Court filing

Emergency Application for Stay — In re MCP No. 165 (OSHA ETS)

Record facts

Court	Supreme Court of the United States (to Justice Kavanaugh, Circuit Justice)
Filed	2021-12-17

Supreme Court of the United States (to Justice Kavanaugh, Circuit Justice) · No. 21-7000 · Doc. 386-2 · 2021-12-17 · Docket on CourtListener

Summary

An emergency application for stay filed December 17, 2021 in the Supreme Court of the United States and addressed to Justice Brett M. Kavanaugh as Circuit Justice, in In re: MCP No. 165, No. 21-7000, Doc. 386-2. Job Creators Network, Independent Bakers Association, Lawrence Transportation Company, Guy Chemical Company, Rabine Group of Companies, Pan-O-Gold Baking Company, Terri Mitchell and Waterblasting, LLC ask that the COVID-19 Vaccination and Testing Emergency Temporary Standard, 86 Fed. Reg. 61,402 (Nov. 5, 2021), be stayed pending the Sixth Circuit's disposition of their petition for review. The application argues the applicants are likely to succeed because the standard exceeds the agency's authority under clear-statement and nondelegation doctrines, and that it will cause irreparable injury. It invokes 28 U.S.C. § 1254(1) and 28 U.S.C. § 1651(a).

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Full text

No. A-____
_________________________

IN THE SUPREME COURT OF THE UNITED STATES
_________________________

IN RE: MCP NO. 165, OCCUPATIONAL SAFETY AND HEALTH
ADMINISTRATION, INTERIM FINAL RULE: COVID-19 VACCINATION AND
TESTING; EMERGENCY TEMPORARY STANDARD 86 FED. REG. 61402.

JOB CREATORS NETWORK, INDEPENDENT BAKERS ASSOCIATION,
LAWRENCE TRANSPORTATION COMPANY, GUY CHEMICAL COMPANY,
RABINE GROUP OF COMPANIES, PAN-O-GOLD BAKING COMPANY, TERRI
MITCHELL, WATERBLASTING, LLC,

Applicants,
v.

OCCUPATIONAL SAFETY & HEALTH ADMINISTRATION, U.S.
DEPARTMENT OF LABOR, MARTIN J. WALSH, Secretary of Labor,
DOUGLAS L. PARKER, Assistant Secretary of Labor for Occupational
Safety and Health Administration,

Respondents.
_________________________

EMERGENCY APPLICATION FOR STAY OF AGENCY STANDARD
PENDING THE DISPOSITION BY THE UNITED STATES COURT OF
APPEALS FOR THE SIXTH CIRCUIT OF A PETITION FOR REVIEW
AND ANY FURTHER PROCEEDINGS IN THIS COURT

_________________________

Jonathan Berry
Counsel of Record
BOYDEN GRAY & ASSOCIATES PLLC
801 17th Street NW, Suite 350
Washington, DC 20006
(202) 955-0618
berry@boydengrayassociates.com

Counsel for Applicants

TABLE OF CONTENTS
INTRODUCTION .......................................................................................................... 1
OPINIONS BELOW ...................................................................................................... 2
JURISDICTION ............................................................................................................. 2
STATUTORY PROVISIONS ......................................................................................... 3
STATEMENT ................................................................................................................. 3
I.
COVID and the Mandate............................................................................... 3
II.
Applicants ...................................................................................................... 5
ARGUMENT .................................................................................................................. 9
I.
Applicants Are Likely to Succeed on the Merits ........................................ 11
A.
Prior Emergency Temporary Standards ............................................... 11
B.
OSHA Lacked Authority to Issue the Mandate .................................... 12
1.
The Mandate Violates Multiple Clear-Statement Doctrines ..... 12
2.
The Mandate Violates the Nondelegation Doctrine ................... 16
C.
Even if OSHA Has Authority, an ETS Is Inappropriate ...................... 18
II.
Applicants Will Suffer Irreparable Injury in the Absence of a Stay ......... 21
III.
The Equities and Public Interest Strongly Favor a Stay ........................... 26
CONCLUSION ............................................................................................................. 29

Exhibit 1
In re: MCP No. 165, ___ F. 4th ___ (6th Cir. 2021).
Exhibit 2
Exhibit 3

Exhibit 4
Exhibit 5
Exhibit 6
BST Holdings, LLC v. OSHA, 17 F.4th 604 (5th Cir. 2021).
BST Holdings, LLC v. OSHA, No. 21-60845, 2021 WL 5166656 (5th
Cir. Nov. 6, 2021).
Affidavits Submitted to Sixth Circuit.
Statutory Addendum.
COVID-19 Vaccination and Testing Emergency Temporary Standard,
86 Fed. Reg. 61,402 (Nov. 5, 2021).

ii
TABLE OF AUTHORITIES

Page(s)
CASES
Ala. Ass’n of Realtors v. HHS, 141 S. Ct. 2485 (2021) .............................. 14, 15, 23, 26
Am. Petroleum Institute v. OSHA, 581 F.2d 493 (5th Cir. 1978) .............................. 12
Asbestos Information Ass’n v. OSHA,
727 F.2d 415 (5th Cir. 1984) ........................................................ 12, 16, 17, 18, 20
Beniske v. Lamone, 138 S. Ct. 1942 (2018) ................................................................. 27
BST Holdings, LLC v. OSHA, 17 F.4th 604 (5th Cir. 2021) ...... 2, 5, 16, 19, 20, 21, 22
Dry Color Mfrs. Ass’n, Inc. v. Dep’t of Labor, 486 F.2d 98 (3d Cir. 1973) ........... 12, 19
Edison Elec. Institute v. OSHA, 849 F.2d 611 (D.C. Cir. 1988) ................................ 11
Fla. Peach Growers Ass’n v. U.S. Dep’t of Labor,
489 F.2d 120 (5th Cir. 1974) ..................................................................... 12, 18, 20
Gundy v. United States, 139 S. Ct. 2116 (2019) .................................................. 16, 17
In re Am. Fed’n of Lab. & Cong. of Indus. Organizations, No. 20-1158, 2020
WL 3125324, at *1 (D.C. Cir. June 11, 2020) ........................................................ 18
In re: MCP No. 165, No. 21-7000, ___ F. 4th ___, 2021 WL ______ (6th Cir.
Dec. 15, 2021)............................................................................................................ 5
Industrial Union Dep’t, AFL-CIO v. Am. Petroleum Inst.,
448 U.S. 607 (1980) ....................................................................... 10, 13, 14, 15, 19
Jacobson v. Massachusetts, 197 U.S. 11 (1905) ......................................................... 15
Maryland v. King, 569 U.S. 435 (2009) ...................................................................... 24
Nken v. Holder, 556 U.S. 418, (2009) ..................................................................... 9, 26
Precision Instrument Mfg. Co. v. Auto Maint. Mach. Co., 324 U.S. 806 (1945) ........ 27
Taylor Diving Salvage v. U.S. Dept. of Labor, 537 F.2d 819 (5th Cir. 1976) ........... 12
Thunder Basin Coal Co. v. Reich, 510 U.S. 200 (1994) .............................................. 22
Util. Air Regul. Grp. v. EPA, 573 U.S. 302 (2014) ............................................ 9, 13, 14

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Whitman v. Am. Trucking Ass’ns, 531 U.S. 457 (2001) ............................................. 17
STATUTES AND REGULATIONS
28 U.S.C. § 1254 ............................................................................................................. 2
28 U.S.C. § 1651 ............................................................................................................ 2
28 U.S.C. § 2112 ............................................................................................................ 5
29 U.S.C. § 655 ........................................................................................... 11, 14, 17, 20
29 C.F.R. § 1903.15 ....................................................................................................... 4
Fed. R. Civ. P. 65(d)(2) ................................................................................................ 31
COVID-19 Vaccination and Testing Emergency Temporary Standard, 86 Fed.
Reg. 61,402 (Nov. 5, 2021) ............................................ 1, 3, 4, 15, 16, 19, 21, 24, 27
Occupational Exposure to COVID-19; Emergency Temporary Standard, 86
Fed. Reg. 32,376-01 (June 21, 2021) ..................................................................... 18
OTHER AUTHORITIES
White House, Remarks by President Biden on Fighting the COVID-19
Pandemic, Sept. 9, 2021, https://www.whitehouse.gov/briefing-
room/speeches-remarks/2021/09/09/remarks-by-president-biden-on-
fighting-the-covid-19-pandemic-3/ ........................................................................... 3
Morgan Chalfant, White House: Move Forward with Mandate Despite Court
Freeze, THE HILL, Nov. 8, 2021,
https://thehill.com/homenews/administration/580586-whits-house-move-
forward-with-mandate-despite-court-freeze .......................................................... 25
Morgan Chalfant, White House Tells Businesses to Move Forward with
Vaccine Mandate, THE HILL, Nov. 18, 2021,
https://thehill.com/homenews/administration/582232-white-house-tells-
businesses-to-move-forward-with-vaccine-mandate ............................................. 25
Press Briefing by Press Secretary Jen Psaki, WHITE HOUSE, Nov. 18, 2021,
https://www.whitehouse.gov/briefing-room/press-
briefings/2021/11/18/press-briefing-by-press-secretary-jen-psaki-
november-18-2021/ ................................................................................................. 25

iv
Spencer Kimball, Business Groups Ask White House to Delay Biden Covid
Vaccine Mandate Until After the Holidays, CNBC,
https://www.cnbc.com/2021/10/25/businesses-ask-white-house-to-delay-
biden-covid-vaccine-mandate-until-after-holidays.html/ ...................................... 28

To the Honorable Brett M. Kavanaugh, Associate Justice of the United States
and Circuit Justice for the Sixth Circuit:
In accordance with Supreme Court Rule 22 and 23 and the All Writs Act, 28
U.S.C. § 1651, applicants Job Creators Network, Independent Bakers Association,
Lawrence Transportation Company, Guy Chemical Company, Rabine Group of
Companies, Pan-O-Gold Baking Company, Terri Mitchell, and Waterblasting, LLC
(“Applicants”) respectfully request an immediate stay of respondent Occupational
Safety & Health Administration’s emergency temporary standard (“Mandate”),
COVID-19 Vaccination and Testing Emergency Temporary Standard, 86 Fed. Reg.
61,402 (Nov. 5, 2021), pending the disposition of Applicants’ petition for review
currently pending before the United States Court of Appeals for the Sixth Circuit
and pending any further proceedings in this Court.
INTRODUCTION
Applicants represent a collection of small businesses and organizations that
challenge the Occupational Safety and Health Administration’s issuance of an
emergency temporary standard (“ETS”) requiring that every company with 100 or
more employees either forcibly vaccinate its employees, forcibly test them every
week, or fire them—subject to steep fines for violations.
Only nine ETSs were issued before 2021, and of the six that were challenged,
only one fully survived—demonstrating the incredible burden OSHA faces. As
eleven circuit judges—three in the Fifth Circuit and eight in the Sixth Circuit—
have concluded, Applicants are likely to succeed on the merits of their claims
because the Mandate violates multiple “clear-statement” rules like the major-

2
questions doctrine, runs perilously close to illegal delegation, and has numerous
other fatal flaws.
Applicants also demonstrate irreparable harm because they will permanently
lose clients and reputation as a result of losing workers who immediately quit and
join smaller companies rather than be vaccinated or tested weekly. The equities and
public interest also favor Applicants. The status quo (before the most-recent
decision below) was that the Mandate has been stayed effectively ab initio.
Moreover, Applicants provide critical food production, delivery, and supply chain
services for the country, which will suffer tremendously as the Mandate suddenly
springs into life.
OPINIONS BELOW
The Sixth Circuit’s three-judge panel order (a 2-1 vote with Judge Larsen
dissenting) dissolving the Fifth Circuit’s stay has not yet been reported. The Fifth
Circuit’s order granting a stay is reported at BST Holdings, LLC v. OSHA, 17 F.4th
604 (5th Cir. 2021). The Fifth Circuit’s order granting an administrative stay is
available at BST Holdings, LLC v. OSHA, No. 21-60845, 2021 WL 5166656 (5th Cir.
Nov. 6, 2021). The Sixth Circuit’s internal operating procedures apparently do not
authorize en banc petitions on such matters. See Sixth Circ. I.O.P. 35(g)–(h).
JURISDICTION
The Circuit Justice has jurisdiction over this application pursuant to 28
U.S.C. § 1254(1) and has authority to grant Applicants relief under the All Writs
Act, 28 U.S.C. § 1651(a).

3
STATUTORY PROVISIONS
Pertinent provisions are reprinted in the Statutory Addendum. See Ex. 5.
STATEMENT
I.
The Mandate and Proceedings Below.
COVID has presented enormous challenges to all Americans. But after
tremendous sacrifices, the nation has turned the page. Despite this, on September
9, 2021, President Biden decided that there is such an urgent, new emergency in
the form of COVID transmission in the workplace that he ordered OSHA to issue an
ETS mandating that nearly every company in the country with 100 or more
employees either forcibly vaccinate its employees, forcibly test them every week, or
fire them. White House, Remarks by President Biden on Fighting the COVID-19
Pandemic, Sept. 9, 2021, https://www.whitehouse.gov/briefing-room/speeches-
remarks/2021/09/09/remarks-by-president-biden-on-fighting-the-covid-19-pandemic-
3/. This mandate would “affect about 100 million Americans,” or “two thirds of all
workers.” Id.

After a substantial delay, OSHA finally issued the Mandate in accordance
with President Biden’s command. COVID-19 Vaccination and Testing Emergency
Temporary Standard, 86 Fed. Reg. 61,402, 61,549–61,550 (Nov. 5, 2021) (Ex. 6). It
became binding on November 5, 2021. See 29 U.S.C. § 655(c).
The Mandate requires all employers of 100 or more employees to “develop,
implement, and enforce a mandatory COVID-19 vaccination policy” and requires
any workers who remain unvaccinated to “undergo [weekly] COVID-19 testing and
wear a face covering at work in lieu of vaccination.” 86 Fed. Reg. at 61,402. It will

4
apply to roughly 80 million workers, of whom OSHA estimated 32 million were not
currently vaccinated, 22 million of whom OSHA expects will get vaccinated against
their wishes because of the Mandate. Id. at 61,435, 61,472.
Under the emergency rule, the employer must verify “the vaccination status
of each employee,” “maintain a record of each employee’s vaccination status,” and
“preserve acceptable proof of vaccination.” Id. at 61,552. For employees who opt not
to get vaccinated, the employer must require a test every seven days, one that
neither the Federal Government nor the employer must pay for and one that the
employees may not take without the supervision of an authorized person. Id. at
61,530, 61,532, 61,551, 61,553. Unvaccinated employees who do not comply must be
“removed from the workplace.” Id. at 61,532. Unvaccinated employees must wear
masks at work with few exceptions. Id. at 61,553. The testing and masking
requirements do not apply to vaccinated employees. Id. Employers who violate the
Act face penalties imposed by OSHA: up to $13,653 for each violation and up to
$136,532 for each willful violation. 29 C.F.R. § 1903.15(d).
Although the Mandate ostensibly goes into full effect on January 4, 2022,
OSHA “strongly encourages employers to implement the required measures to
support employee vaccination as soon as practicable.” Id. at 61,549–61,550
(emphasis added). The Mandate says it is “critical[ly] importan[t]” to “implement[]
the requirements in this ETS, including the recordkeeping and reporting provisions,
as soon as possible,” id. at 61,505, and “it is essential that remediation efforts at a
workplace be undertaken immediately,” id. at 61,545.

5
On November 4, 2021, Applicants filed suit in the Eighth Circuit and sought
a stay of the Mandate, attaching affidavits demonstrating the imminent and
irreparable harm that would befall them if the Mandate were not stayed. See Job
Creators Network v. U.S. Dep’t of Labor, No. 21-3491 (8th Cir.). During this time, in
a response to petitions filed in the Fifth Circuit, that court issued an administrative
stay and then a stay pending review of the Mandate. BST Holdings, LLC v. OSHA,
17 F.4th 604 (5th Cir. 2021) (Ex. 2).
All of these cases (as well as ones in other circuits) were later transferred to
the Sixth Circuit pursuant to the lottery process in 28 U.S.C. § 2112.
Applicants were among those who sought initial en banc hearing, which the
Sixth Circuit denied in an evenly divided vote, with Chief Judge Sutton writing a
lengthy dissent (joined by seven other judges) explaining not only why the court
should hear the matter en banc but also why the Mandate is illegal. In re: MCP No.
165, No. 21-7000, ___ F. 4th ___, 2021 WL 5914024 (6th Cir. Dec. 15, 2021). The
government also sought to dissolve the Fifth Circuit’s stay, and a three-judge panel
of the Sixth Circuit granted the government’s motion by a 2-1 vote, with Judge
Larsen dissenting. Ex. 1. The Sixth Circuit’s internal operating procedures
apparently do not authorize en banc petitions challenging rulings on motions for
stays of agency rules. See Sixth Circ. I.O.P. 35(g)–(h).
II.
Applicants
Job Creators Network is a nonpartisan membership organization whose
mission is to educate employees of Main Street America and protect the 85 million

6
people who depend on the success of small businesses. Affidavit of Alfredo Ortiz, Ex.
4, ¶¶ 2–5.1 Its members will suffer tremendous harm from the Mandate. See id.,
¶¶ 6–11.
Independent Bakers Association is national trade association of over 200
family-owned wholesale bakeries and allied industry trades. Affidavit of Nicholas
Pyle, Ex. 4, ¶¶ 2–4. IBA’s affidavit explains in detail how its members were deemed
“essential” during lockdowns because of their critical role in feeding the country—
but these members are facing dramatic worker shortages already, and the Mandate
is expected to cause 20–30% of employees to leave, which will severely “disrupt
retail trade patterns, exacerbate fast food supply chain issues and increase the food
insecurity for the nation's most nutritionally at risk.” Id., ¶¶ 5–10. IBA has
standing through its members, one of which has submitted an affidavit explaining
how the Mandate will drastically worsen an already-critical worker shortage for
every link in its production and supply chain, leading to severe reputational and
public harms, including the communities supported by the company’s wages.
Affidavit of Mike McKee, Ex. 4, ¶¶ 10–13.
Lawrence Transportation Company is a refrigerated truckload carrier in
Rochester, Minnesota, with over 100 employees and thus subject to the Mandate.
Affidavit of Eric Lawrence, Ex. 4, ¶¶ 2–3. The company was deemed “essential”
during the COVID lockdowns, id., ¶ 9, and has encouraged its employees to get
vaccinated, id., ¶ 2. The Mandate will cause irreparable harm because Lawrence

1 All affidavits cited herein were presented to the Sixth Circuit below. See ECF No. 98 (6th Cir. Nov.
23, 2021).

7
Transportation is already facing a severe truck driver shortage. Id., ¶ 4. These
drivers and the mechanics who repair the trucks require specialized licenses and
training. Id. Because of this, Lawrence Transportation “simply cannot hire more
employees and have them start quickly.” Id.
Approximately 10–15% of Lawrence Transportation’s workforce “would
rather walk off the job than be forced to get a vaccine or undergo weekly testing,”
and there is an incentive to do this sooner rather than later. Id., ¶ 5. These workers
“cannot be replaced at any point in the near future” and would have a “devastating”
effect on the company. Id., ¶¶ 6–7. Deliveries will be “delayed or canceled, resulting
in severe financial and reputational damages for the Company, as well as a likely
ripple effect of losing business to smaller trucking companies.” Id., ¶ 7.
The Company “would likely have to save costs by laying off non-drivers like
office employees,” who “are almost all vaccinated.” Id. This means “the mandate
would result in vaccinated people losing their jobs.” Id. (emphasis added). The
Mandate also imposes irreparable logistical harms, as drivers are on the road “for 7
to 10 days at a time, making it nearly impossible to get tested weekly.” Id., ¶ 10.
The Mandate is designed to “force[] those drivers either to get vaccinated, or quit.”
Id.
The general public would also suffer because Lawrence Transportation
delivers groceries that must be refrigerated. Id., ¶ 9. “[T]hose deliveries will not be
made, and people will not be able to get food deliveries to their grocery stores.” Id.

8
Guy Chemical Company LLC is a manufacturer in Somerset County,
Pennsylvania, with over 160 employees, and thus is subject to the Mandate.
Affidavit of Guy Berkebile, Ex. 4, ¶¶ 1–4. Guy Chemical was deemed “essential”
during the pandemic lockdowns, due to its work producing materials for household
and construction products. Id., ¶ 9. Guy Chemical is already facing an intense
worker shortage, and its employees typically must have extensive training
(required, ironically, by OSHA) and specialized knowledge that cannot be learned
quickly, and—critically—a majority of employees at the Company would refuse to
comply with the Mandate because Guy Chemical has attracted workers who have
left other companies with onerous vaccine and masking requirements. Id., ¶¶ 6–7. If
even 25% of Guy Chemical’s workers refuse to show up, the Company would be
unable to complete orders, resulting not only in lost business but also reputational
damages. Id., ¶ 8. The Mandate also imposes irreparable harm in the form of
logistics: the onerous testing requirements will have the effect of forcing companies
to abandon testing and mandate the vaccine—“[t]here is no practical choice.” Id., ¶
10.
The Rabine Group of Companies have over 300 employees, including over
100 just at Pipe View L.L.C. These companies perform critical infrastructure
repairs for damaged roofs, roads, HVAC systems, and commercial doors and docks,
as well as snow removal—and, like the other Applicants, are already suffering from
severe worker shortages even without the estimated 20% of workers who will leave
because of the Mandate. Affidavit of Gary Rabine, Ex. 4, ¶¶ 2–6. These projects

9
must be done immediately or customers may face legal liability and physical
dangers, but the Mandate will prevent the Group’s companies from meeting
timeliness obligations, causing tremendous public harm, as well as critical business
and reputational damages. Id., ¶¶ 7–11.
As Job Creators Network CEO Alfredo Ortiz states, these companies
represent only “the tip of the iceberg.” Ortiz Affidavit, Ex. 4, ¶ 11. Thousands of
other companies are in the same situation.
Terri Mitchell is the Administrations Manager at Guy Chemical and is
determined not to receive the vaccine because she previously had the coronavirus
and has the confirmed presence of SARS-COV-2 antibodies. Affidavit of Terri
Mitchell, Ex. 4, ¶¶ 2, 4–5. She also refuses to subject herself to the physical harms
and indignity of involuntary weekly testing. Id., ¶ 5. She would rather lose her
position than comply with the Mandate, and—as a result of her role at the
company—knows that “a majority of employees at Guy Chemical feel the same
way.” Id., ¶ 6.
ARGUMENT
The traditional stay factors all support granting relief to Applicants. See
Nken v. Holder, 556 U.S. 418, 426–27 (2009).
Applicants are likely to prevail on the merits for several reasons. First, the
Mandate violates multiple “clear-statement” doctrines, most notably the major-
questions doctrine, which states that Congress must “speak clearly if it wishes to
assign to an agency decisions of vast economic and political significance.” Util. Air
Regul. Grp. v. EPA, 573 U.S. 302, 324 (2014). But there is not the slightest hint that

10
Congress gave OSHA the power to issue emergency orders covering 84 million
Americans and resulting in compelled vaccination of over 22 million of them.
This Court has previously warned OSHA about issuing such edicts: “In the
absence of a clear mandate in the [OSH] Act, it is unreasonable to assume that
Congress intended to give the Secretary the unprecedented power over American
industry that would result from the Government’s view.” Industrial Union Dep’t,
AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607, 645, 651 (1980) (plurality). The
Court even warned OSHA against abusing ETSs just like the Mandate: “Congress
repeatedly expressed its concern about allowing the Secretary to have too much
power over American industry,” and thus Congress “narrowly circumscribed the
Secretary’s power to issue temporary emergency standards.” Id. (emphasis added).
Shockingly, the majority opinion below fails to address these holdings.
Second, the Mandate violates the nondelegation doctrine, which prohibits
Congress from transferring legislative powers carte blanche to an executive agency.
Third, even if OSHA did have the power to issue the Mandate, there is no
unforeseen emergency necessitating a one-size-fits-all ETS, especially when the
Mandate will severely disrupt essential services and—in a cruel twist—result in
companies laying off vaccinated workers to stay solvent.
Applicants have also demonstrated irreparable injury and favorable equities.
Applicants are small businesses deemed “essential” during lockdowns and have
struggled to survive the last two years. As the attached detailed affidavits make
clear, these companies face the distinct prospect that a substantial number of

11
employees—a majority in some cases—will walk off the job rather than comply with
the Mandate. Critically, they have every incentive to do this immediately rather
than wait for the Mandate’s deadlines to kick in. This will trigger a cascade of
irreparable injuries as companies are unable to satisfy work orders, leading to lost
clients, damaged reputation, and the threat of shutting their doors. After over a
month of dormancy, the Mandate was suddenly sprung back into life by the Sixth
Circuit, greatly upending the status quo and threatening imminent chaos.
The public will suffer tremendously, too. Applicants provide critical supply-
chain services like food production, grocery store food deliveries, and emergency
repairs for buildings and roads. By forcing those companies to operate without a
sizable part of their workforce, the Mandate will cause immediate shortages at
grocery stores, shortages of household and commercial goods, and languishing
critical infrastructure failures.
I.
Applicants Are Likely to Succeed on the Merits.
A.
Prior Emergency Temporary Standards
The Occupational and Health Safety Act of 1970 (“OSH Act”) provides the
Secretary of Labor the incredible power to issue ETSs that are immediately
effective upon publication in the Federal Register, without having to comply with
any of the requirements of the Administrative Procedure Act. 29 U.S.C. § 655(c).
The Secretary must determine, inter alia, that the covered “employees are exposed
to grave danger from exposure to substances or agents determined to be toxic or
physically harmful or from new hazards.” Id. The Secretary has delegated this

12
authority to the Assistant Secretary for Occupational Safety and Health. Edison
Elec. Institute v. OSHA, 849 F.2d 611, 614 (D.C. Cir. 1988).
This is an “extraordinary power,” Fla. Peach Growers Ass’n v. U.S. Dep’t of
Labor, 489 F.2d 120, 129 (5th Cir. 1974), and represents “OSHA’s most dramatic
weapon in its enforcement arsenal.” Asbestos Information Ass’n v. OSHA, 727 F.2d
415, 426 (5th Cir. 1984). This weapon must be “delicately exercised, and only in
those emergency situations which require it.” Peach Growers, 489 F.2d at 129–30.
Before 2021, OSHA had issued fewer than 10 ETSs. Of the six that were
challenged, five (83.3%) were fully or partially vacated or stayed, Asbestos, 727 F.2d
at 426; Am. Petroleum Institute v. OSHA, 581 F.2d 493, 503 (5th Cir. 1978), aff’d,
448 U.S. 607 (1980); Taylor Diving Salvage v. U.S. Dept. of Labor, 537 F.2d 819, 821
(5th Cir. 1976); Peach Growers, 489 F.2d at 129; Dry Color Mfrs. Ass’n, Inc. v. Dep’t
of Labor, 486 F.2d 98 (3d Cir. 1973).
This
lousy
batting
average—even when defending
limited
ETSs—
demonstrates the extraordinarily high burden OSHA must satisfy. As demonstrated
next, the Mandate does not survive this scrutiny.
B.
OSHA Lacked Authority to Issue the Mandate.
Applicants are likely to succeed on the merits of their challenge to the
Mandate for several reasons.
1.
The
Mandate
Violates
Multiple
Clear-Statement
Doctrines.
The Mandate represents an unprecedented assertion of power by OSHA,
regulating far more than any prior ETS in OSHA’s 50 years: 84 million Americans

13
(32 million currently unvaccinated), in every industry, representing almost 2/3 of all
workers across the entire country. Its dictates are also unprecedented: OSHA is
press-ganging private companies into being vaccination police who forcibly inject or
test their employees—or fire them. For the first time in history, OSHA seeks to
regulate the citizenry itself.
Under the major-questions doctrine, “[w]hen an agency claims to discover in
a long-extant statute an unheralded power to regulate a significant portion of the
American economy, we typically greet its announcement with a measure of
skepticism.” Util. Air Regul. Grp. v. E.P.A., 573 U.S. 302, 324 (2014). “We expect
Congress to speak clearly if it wishes to assign to an agency decisions of vast
economic and political significance.” Id.
The Mandate fails this doctrine because there is no “clear statement” in
§ 655(c) giving OSHA such sweeping powers over the nation’s economy, nor to
mandate vaccination or intrusive weekly testing for 32 million people, nor to expand
its purview beyond the workplace.
Only once before has OSHA attempted anything close to the Mandate—and
this Court rejected it and forewarned OSHA from trying again. In the famous
“benzene case,” OSHA had issued a permanent standard pursuant to § 655,
governing low levels of benzene, under such a broad theory of workplace harm that
OSHA could effectively regulate substantial portions of the nation’s industry.
Industrial Union Dep’t, AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607, 623 (1980)
(“API”). The Court rejected OSHA’s power grab: “In the absence of a clear mandate

14
in the [OSH] Act, it is unreasonable to assume that Congress intended to give the
Secretary the unprecedented power over American industry that would result from
the Government’s view” of § 655.” Id. at 645 (plurality). The government’s
argument “would in turn justify pervasive regulation limited only by the constraint
of feasibility.” Id. The Court also criticized OSHA for “apply[ing] the same limit to
all [industries], largely as a matter of administrative convenience.” Id. at 650.
Significantly, the Court made these statements in the context of a permanent
standard while noting that OSHA’s ETS authority is even more “narrowly
circumscribed.” Id. at 651. The Court warned OSHA against abusing ETSs:
“Congress repeatedly expressed its concern about allowing the Secretary to have too
much power over American industry,” and thus Congress “narrowly circumscribed
the Secretary’s power to issue temporary emergency standards.” Id. (emphasis
added). But the Mandate thumbs its nose at this precedent. And, shockingly, the
majority opinion below fails to address these holdings.
Nor can OSHA claim that COVID provides cause to ignore API. The Court
recently relied on the major-questions doctrine in holding that the CDC’s eviction
moratorium was illegal. Ala. Ass’n of Realtors v. HHS, 141 S. Ct. 2485, 2489 (2021).
The moratorium applied to “[a]t least 80% of the country, including between 6 and
17 million tenants at risk of eviction.” Id. Those figures pale in comparison to the
Mandate, which applies to 100% of the country’s geographic scope and over 84
million individuals (forcing vaccination or testing on 32 million of them).

15
In the Sixth Circuit, the government acknowledged that the Mandate causes
vast economic and political consequences, but claimed that the major-questions
doctrine does not apply at all because the text of 29 U.S.C. § 655(c) “unambiguously”
authorizes such seismic agency actions. It is quite a stretch to claim that Congress
unambiguously gave OSHA the power to impose requirements of incalculable
economic and political consequences:
x Imposing vaccine-or-testing requirements for 84 million Americans.
See 86 Fed. Reg. at 61,471.
x Requiring forcible vaccination or testing of over 31 million of those
Americans, 22.7 million of whom will be vaccinated against their
wishes. Id. at 61,471–61,472.
x Imposing these requirements on every single industry in the country,
amounting to over 264,000 businesses. Id. at 61,475.
x Imposing direct compliance costs of nearly $3 billion, not even counting
the economic fall-out, which will be incalculable. Id. at 61,493.
But, again, there is no need to speculate on whether OSHA has this power.
This Court rejected OSHA’s position 40 years ago. See API, 448 U.S. at 645, 650–51
(plurality). The Sixth Circuit lacked the power to disregard this Court’s holding.
Because there is no clear Congressional authorization, the Mandate fails the
major-questions doctrine and violates API.
This Court has similarly held that it expects Congress to use “exceedingly
clear language if it wishes to significantly alter the balance between federal and

16
state power.” Ala. Ass’n, 141 S. Ct. at 2489. But implementing widespread general
health programs is traditionally a matter for the States. See Jacobson v.
Massachusetts, 197 U.S. 11, 38 (1905) (“The safety and the health of the people of [a
State] are, in the first instance, for that [State] to guard and protect” and “are
matters that do not ordinarily concern the national government.”); BST Holdings,
17 F.4th at 617. As noted above, there is no clear authority in the OSH Act for the
Mandate, and thus it fails for this additional reason.
2.
The Mandate Violates the Nondelegation Doctrine.
If OSHA truly does have such broad statutory authority to issue the
Mandate, then § 655 violates the nondelegation doctrine. “[B]y directing that
legislating be done only by elected representatives in a public process, the
Constitution sought to ensure that the lines of accountability would be clear: The
sovereign people would know, without ambiguity, whom to hold accountable for the
laws they would have to follow.” Gundy v. United States, 139 S. Ct. 2116, 2134
(2019) (Gorsuch, J., dissenting, joined by Roberts, C.J., and Thomas, J.). Thus,
Congress may not “delegate ... powers which are strictly and exclusively legislative.”
Wayman v. Southard, 10 Wheat. 1, 42–43 (1825). This requirement—known as the
nondelegation doctrine—is a central component of separation of powers.
The original understanding of the Constitution prohibited any transfer of
Congress’s vested legislative powers to any other entity. Gundy, 139 S. Ct. at 2135–
37 (Gorsuch, J., dissenting). Congress must “make[] the policy decisions when
regulating private conduct.” Id. OSHA’s interpretation of § 655(c) violates this
original understanding. Under OSHA’s view, “what constitutes a risk worthy of

17
Agency action is a policy consideration”—an “essentially legislative task.” Asbestos,
727 F.2d at 421, 425; 86 Fed. Reg. at 61,405 (“determinations are ‘essentially
legislative’”). But policymaking is the role of Congress, and it “would frustrate ‘the
system of government ordained by the Constitution’ if Congress could merely
announce vague aspirations and then assign others the responsibility of adopting
legislation to realize its goals.” Gundy, 139 S. Ct. at 2133 (Gorsuch, J., dissenting).
Indeed, OSHA’s interpretation of § 655 would run afoul even of the more-
lenient modern interpretations of the nondelegation doctrine. Gundy, 139 S. Ct. at
2139 (Gorsuch, J., dissenting). Under OSHA’s view, “the degree of agency
discretion” and “the scope of the power congressionally conferred” are practically
limitless. Whitman v. Am. Trucking Ass’ns, 531 U.S. 457, 475 (2001).
OSHA cannot claim surprise, as API held that if OSHA were correct that
§ 655 permits regulation of the national economy, then “the statute would make
such a sweeping delegation of legislative power that it might be unconstitutional
under the Court’s reasoning in” its nondelegation cases. 448 U.S. at 646 (plurality).
The Court chose to apply a constitutional-avoidance canon to reject a broad
interpretation of OSHA’s power. Id.
The Court here should follow the same path, but if the Court nonetheless
adopts OSHA’s view, the Court should conclude that § 655 violates the
nondelegation doctrine.

18
C.
Even if OSHA Has Authority, an ETS Is Inappropriate.
OSHA has also failed to satisfy the statutory requirements for imposing an
ETS. The Court must “take a ‘harder look’ at OSHA’s action” because it was not
subject to the APA. Asbestos, 727 F.2d at 421.
No Necessity. OSHA can invoke its extraordinary ETS powers only upon a
finding that an urgent emergency has arisen such that the agency simply cannot
wait for the normal notice-and-comment process to occur. 29 U.S.C. § 655(c). That
is, OSHA must “prove[] that the ETS, OSHA’s most dramatic weapon in its
enforcement arsenal, is ‘necessary’ to achieve the projected benefits.” Asbestos, 727
F.2d at 426 (emphasis added).
“[T]he Agency’s failure to act may be evidence that a situation is not a true
emergency.” Asbestos, 727 F.2d at 423; see Peach Growers, 489 F.2d at 131 (the
alleged grave concern “has been going on during the last several years thus failing
to qualify for emergency measures”). But it is common knowledge that the COVID
pandemic has been ongoing since early 2020, and vaccines have been widely
available for almost all of 2021. OSHA provides no persuasive justification for why
there is suddenly such an emergency now when so many Americans have already
gotten vaccinated.
Notably, OSHA refused to issue an ETS in 2020 because “employers are
maintaining hazard-free work environments.” In re Am. Fed’n of Lab. & Cong. of
Indus. Organizations, No. 20-1158, 2020 WL 3125324, at *1 (D.C. Cir. June 11,
2020). That was during the height of the pandemic and is especially telling because
OSHA claims it is mandated to issue an ETS when conditions warrant.

19
Occupational Exposure to COVID-19; Emergency Temporary Standard, 86 Fed. Reg.
32,376-01, 32,380 (June 21, 2021) (claiming § 655(c) “is not discretionary”).
To be sure, an agency can change its mind. But COVID vaccines have been
around for nearly a year, and no explanation was offered for why OSHA issued the
Mandate only now, especially when vaccination rates are even better than before. In
the Sixth Circuit, the government explained away its refusal to issue an ETS in
June 2020 on the basis that there were no vaccines then. But the availability of
vaccines now makes it less necessary—not more—to impose something as drastic as
the Mandate.
In API, the Court criticized OSHA for “decid[ing] to apply the same limit to
all [industries], largely as a matter of administrative convenience.” API, 448 U.S. at
650 (plurality). “[I]t is expected that even an emergency temporary standard not
overlook those obvious distinctions among … uses and plant practices that make
certain regulations that are appropriate in one category of cases entirely
unnecessary in another.” Dry Color, 486 F.2d at 105. The Fifth Circuit correctly
held that the Mandate is not “necessary” because a one-size-fits-all rule is
inappropriate. BST Holdings, 17 F.4th at 615–16. The government argued below
that ETSs need not make “employer-by-employer or employee-by-employee”
distinctions. But an ETS must at least make sensible industry-by-industry
distinctions, and that was not even attempted here. Dry Color, 486 F.2d at 105.
In an attempt to show some degree of tailoring, the government pointed
below to exceptions for employees who work exclusively alone or outside. But these

20
are trivial, especially compared to the 84 million Americans who will nonetheless be
covered. For example, the Mandate estimates that only 9% of landscaping and
groundkeepers will qualify as working exclusively outdoors—and that is the highest
percentage of any occupation. 86 Fed. Reg. at 61,461. If only 9% of landscapers are
deemed to work outside, the entire exception is a fig leaf designed only to provide
the false sense of tailoring.
Further, “an ETS must, on balance, produce a benefit the costs of which are
not unreasonable. The protection afforded to workers should outweigh the economic
consequences to the regulated industry,” Asbestos, 727 F.2d at 423–24, “without
eliminating the [relevant] enterprise and the associated jobs,” Peach Growers, 489
F.2d at 130. But the Mandate will have precisely that effect and, ironically, will
encourage employees to switch to employers who are not covered by the Mandate—
causing severe economic disruption in the meantime. Pyle Affidavit, Ex. 4, ¶ 8;
Lawrence Affidavit, Ex. 4, ¶ 5; Berkebile Affidavit, Ex. 4, ¶¶ 7–8. As one Applicant
notes, the Mandate will actually force him to lay off vaccinated workers to save
costs. Lawrence Affidavit, Ex. 4, ¶ 7.2
No Grave Danger Demonstrated from Workplace Transmission. OSHA
must also demonstrate that the Mandate addresses a “grave” danger. 29 U.S.C.
§ 655(c). The Fifth Circuit aptly concluded that no grave danger would be prevented
by the Mandate. BST Holdings, 17 F.4th at 613–14. The question is not whether

2 Moreover, side effects from vaccines are a critical cost of the Mandate—but OSHA has deliberately
blinded itself to any calculation of these costs by saying it “will not enforce 29 CFR 1904’s recording
requirements to require any employers to record worker side effects from COVID-19 vaccination.”
OSHA, FAQ, https://www.osha.gov/coronavirus/faqs#vaccine.

21
COVID generally presents a grave danger, but whether the lack of a vaccine
mandate and weekly testing for the next few months presents a grave danger to
nearly every workplace in the entire nation such that OSHA was not required to go
through notice-and-comment rulemaking. Asbestos, 727 F.2d at 427. In other words,
OSHA “cannot use its ETS powers as a stop-gap measure” to avoid notice-and-
comment. BST Holdings, 17 F.4th at 616.
OSHA’s prior actions declining to issue an ETS, as well as the lack of
tailoring discussed above confirm no such grave danger. Point in case: employees
with natural immunity from prior COVID infections are included in the Mandate,
but OSHA failed to conclude that such workers actually face a grave danger.
Rather, OSHA stated that it “is unable to establish that such immunity eliminates
grave danger.” 64 Fed. Reg. at 61,422. Through double negatives, OSHA is saying a
lack of evidence showing grave danger is somehow now enough to announce that a
grave danger exists. This alone warrants finding a lack of substantial evidence. See
BST Holdings, 17 F.4th at 615.
II.
Applicants Will Suffer Irreparable Injury in the Absence of a Stay.
Absent a stay, companies will immediately have to start the groundwork for
complying, such that they are in full compliance before the vaccine deadline hits in
early January. The Mandate expressly recognizes this fact: to “reduce burdens on
both employers and employees when the compliance dates for the additional
requirements for employees who are not fully vaccinated arrive,” OSHA “strongly
encourages employers to implement the required measures to support employee

22
vaccination as soon as practicable” after issuance of the Mandate. 86 Fed. Reg. at
61,549–61,550 (emphasis added). Elsewhere, the Mandate says it is “critical[ly]
importan[t]” to “implement[] the requirements in this ETS, including the
recordkeeping and reporting provisions, as soon as possible,” id. at 61,505, and “it is
essential that remediation efforts at a workplace be undertaken immediately,” id. at
61,545.
Having to comply with these requirements will undoubtedly yield irreparable
harm. “[C]omplying with a regulation later held invalid almost always produces the
irreparable harm of nonrecoverable compliance costs.” Thunder Basin Coal Co. v.
Reich, 510 U.S. 200, 220–21 (1994) (Scalia, J., concurring). That alone is sufficient
here. OSHA itself estimated there will be $2.98 billion in compliance costs over six
months. 86 Fed. Reg. at 61,493. Even if that amount were evenly spread over the
six-month life of the ETS, it would mean $16.5 million every single day. But the
costs are not evenly spread. They are overwhelmingly frontloaded (and thus
imminent) because companies will have to create all these programs and deal with
lost time for any employees who get vaccinated before the deadlines hit.
As the Fifth Circuit found, employees are facing imminent, irreparable harm
because the Vaccine Mandate forces “reluctant individual recipients … to a choice
between their job(s) and their jab(s)”; and companies are facing imminent,
irreparable harm in the form of “business and financial effects of a lost or
suspended employee, compliance and monitoring costs associated with the Mandate,
the diversion of resources necessitated by the Mandate, or by OSHA’s plan to

23
impose stiff financial penalties on companies that refuse to punish or test unwilling
employees.” BST Holdings, 17 F.4th at 618.
Those findings are amply supported by the record in this case. Applicants
are already facing intense labor shortages, and they often require many employees
with specialized licenses or training, leading to an extremely small pool of potential
hires, plus on-boarding processes that prevent new hires from quickly ramping up.
McKee Affidavit, Ex. 4, ¶ 7; Lawrence Affidavit, Ex. 4, ¶ 4; Berkebile Affidavit, Ex.
4, ¶ 6; Rabine Affidavit, Ex. 4, ¶¶ 4–5. But sizable portions of their workforce—
sometimes a majority—have indicated that they will not comply with the Mandate,
and to maximize the odds of finding a job at a company not covered by the Mandate,
there is a strong incentive for them to leave soon, regardless of when OSHA will
actually start enforcing the Mandate, and changing jobs is especially easy given the
low unemployment rate. Berkebile Affidavit, Ex. 4, ¶ 7; Lawrence Affidavit, Ex. 4, ¶
5.
Because of the difficulty in finding replacement workers, these companies
will be drastically short in workers, meaning cascading lost business with no hope
of recovery. Ala. Ass’n, 141 S. Ct. at 2489. These delayed and canceled shipments
and services will sour customer relationships, leading to lost business and
reputational harm. Pyle Affidavit, Ex. 4, ¶ 7; Lawrence Affidavit, Ex. 4, ¶¶ 7–8;
Berkebile Affidavit, Ex. 4, ¶ 8; Rabine Affidavit, Ex. 4, ¶ 8. To stay afloat,
companies will have to make drastic employment cuts, including of vaccinated
workers. See, e.g., Lawrence Affidavit, Ex. 4, ¶ 7.

24
The Mandate’s onerous logistical requirements for testing will likewise cause
irreparable harm by effectively “forc[ing] [workers] either to get vaccinated, or quit.”
Id., ¶ 10. Companies often lack the manpower to carry out mass testing—meaning
workers must leave the premises to get tested, causing additional lost productivity.
Berkebile Affidavit, Ex. 4, ¶ 10. The testing regime is undoubtedly designed to be so
burdensome that it presents no real option for the vast majority of companies.
For the individual Applicant Terri Mitchell, a compelled vaccination
represents an irreparable harm because it cannot be undone, and involuntary nasal
or throat testing—by edict of the President—is a breach of personal autonomy. As
Justice Scalia said: “I doubt that the proud men who wrote the charter of our
liberties would have been so eager to open their mouths for royal inspection.”
Maryland v. King, 569 U.S. 435, 482 (2013) (Scalia, J., dissenting).
Incredibly, OSHA never even bothered to calculate the irreparable damage
that will occur from employees leaving businesses because of the impending
Mandate deadlines, and the resulting cascading destruction of an already-stressed
supply chain. Those figures would dwarf the $3 billion in compliance costs.
The government argued below that only a small percentage of employees in
the past actually quit rather than be vaccinated. But those people were the early
adopters. At this point, if someone has not gotten vaccinated, he is unlikely to be
persuadable—and he means it when he says he will switch jobs rather than comply.
Indeed, the entire premise of the Mandate is that the remaining unvaccinated
people cannot be persuaded by the measures used in the past: “OSHA has found

25
that neither reliance on voluntary action by employers nor OSHA non-mandatory
guidance is an adequate substitute for specific, mandatory workplace standards at
the federal level.” 86 Fed. Reg. at 61,445.
Nor can the government claim that companies have not yet started incurring
costs, perhaps because company owners saw that the Fifth Circuit maintained a
stay since November 6, 2021. The White House has repeatedly told businesses to
move forward despite the Fifth Circuit’s rulings, as conveyed by prominent press
reports:
x Morgan Chalfant, White House: Move Forward with Mandate Despite
Court
Freeze,
THE
HILL,
Nov.
8,
2021,
https://thehill.com/homenews/administration/580586-whits-house-
move-forward-with-mandate-despite-court-freeze.
x Morgan Chalfant, White House Tells Businesses to Move Forward with
Vaccine
Mandate,
THE
HILL,
Nov.
18,
2021,
https://thehill.com/homenews/administration/582232-white-house-tells-
businesses-to-move-forward-with-vaccine-mandate.
Far from consisting of the usual puffery about their belief in ultimately
prevailing, these White House statements stepped perilously close to the line of
encouraging contempt of the Fifth Circuit’s order. On November 18, White House
Press Secretary Jen Psaki stated during a press conference that the government
still expects businesses to take action in advance of the now-stayed Mandate’s
January 4 deadline and that the government still views that deadline as the key

26
date for compliance. See Press Briefing by Press Secretary Jen Psaki, WHITE HOUSE,
Nov.
18,
2021,
https://www.whitehouse.gov/briefing-room/press-
briefings/2021/11/18/press-briefing-by-press-secretary-jen-psaki-november-18-2021/
(agreeing that the White House is “still working off of that January 4th compliance
deadline” and “still heading towards the same timeline,” and therefore businesses
are “urg[ed]” “to move forward with the President’s vaccine and weekly testing
rule”).
The government seeks to have it both ways: they tell the courts that there are
no immediate costs, then they tell the public to start complying now if they know
what is good for them.
An immediate stay is both necessary and appropriate, given the imminent
and irreparable harms imposed by the Mandate. The Fifth Circuit correctly
recognized this. This Court should grant this Application.
III.
The Equities and Public Interest Strongly Favor a Stay.
The equities and public interest likewise favor a stay. Nken, 556 U.S. at 435.
It “is indisputable that the public has a strong interest in combating the
spread of the COVID–19 Delta variant. But our system does not permit agencies to
act unlawfully even in pursuit of desirable ends.” Ala. Ass’n, 141 S. Ct. at 2490.
That ends the matter: OSHA has no equitable interest in enforcement of an invalid
ETS.
Moreover, there is an interest in maintaining the status quo, under which the
Mandate has not been in effect for nearly its entire existence. Nken, 556 U.S. at 429.

27
The Mandate has been stayed almost since the moment it was issued, and the Sixth
Circuit’s decision to spring the Mandate back into life—on a Friday night after close
of business, no less—will cause incredible chaos.
Further, the government has diminished equities. OSHA seeks to press-gang
private parties into forcibly vaccinating or testing over 30 million employees. And
OSHA issued the Mandate without even posting drafts or summaries online to
inform the public—unwarranted secrecy in the false name of efficiency, given that
the COVID pandemic has been around for nearly two years. Benisek v. Lamone, 138
S. Ct. 1942, 1944 (2018) (equitable interests “tilt[] against” a party who waits
“years” to initiate action). Meanwhile, even before the Mandate was issued, the
Department of Labor demanded that companies “begin the process of adopting
vaccination mandates,”3 an obvious in terrorem scheme where the government uses
threat of the Mandate to strong-arm companies into giving the government what it
wants, regardless of whether the Mandate will be upheld in court.
Threatening to issue illegal edicts as a strategy to force involuntary
vaccinations and testing is a cynical exercise of government powers, unworthy of
equitable charity. Precision Instrument Mfg. Co. v. Auto. Maint. Mach. Co., 324 U.S.
806, 815 (1945).
The Mandate itself even stoops to personal attacks against those who
question OSHA’s authority, labeling those who “resist curbs on personal freedoms”

3 Ben Penn, Top DOL Lawyer Courts Business Support for Biden’s Vaccine Order, Bloomberg Law,
Sept. 10, 2021, https://news.bloomberglaw.com/daily-labor-report/top-dol-lawyer-courts-business-
support-for-bidens-vaccine-order.

28
as suffering from “psychological reactance,” which OSHA implies is some kind of
undesirable mental condition. 86 Fed. Reg. at 61,444.
By contrast, Applicants have strong equitable interests. They have already
suffered greatly over the last two years and now face terribly difficult choices about
the viability of their businesses, as demonstrated above.
There are also very strong public interests in staying the Mandate, as the
attached affidavits explain in detail. Applicants were deemed “essential” during the
lockdown because they serve as critical cogs in our nation’s economy. Lawrence
Affidavit, Ex. 4, ¶ 9; Berkebile Affidavit, Ex. 4, ¶ 9; Rabine Affidavit, Ex. 4, ¶ 10.
These companies represent just a tiny fraction of those affected. Nationwide, thirty
percent of unvaccinated workers have indicated they will not comply, which will
wreak havoc on supply chains. See, e.g., Spencer Kimball, Business Groups Ask
White House to Delay Biden Covid Vaccine Mandate Until After the Holidays,
CNBC,
https://www.cnbc.com/2021/10/25/businesses-ask-white-house-to-delay-
biden-covid-vaccine-mandate-until-after-holidays.html.
Food will not be produced or transported to grocery stores, schools, and
nursing homes; household products will not be manufactured; damaged roofs and
sinkholes will not be repaired; snow will not get removed; and buildings with
broken HVAC systems will turn into freezing meat lockers. Pyle Affidavit, Ex. 4,
¶ 10; McKee Affidavit, Ex. 4, ¶ 11; Lawrence Affidavit, Ex. 4, ¶ 9; Berkebile
Affidavit, Ex. 4, ¶ 9; Rabine Affidavit, Ex. 4, ¶ 9. This in turn will cause a cascade
effect that takes down companies at each link in the supply chain, along with the

29
workers at those companies and their local communities. McKee Affidavit, Ex. 4,
¶¶ 12–13.
CONCLUSION
For the foregoing reasons, Applicants respectfully request a stay pending the
disposition of Applicants’ petition for review currently pending before the United
States Court of Appeals for the Sixth Circuit and pending any further proceedings
in this Court.
Respectfully submitted,

By_________________________________
Jonathan Berry
Counsel of Record

Jonathan Berry
Counsel of Record
BOYDEN GRAY & ASSOCIATES PLLC
801 17th Street NW, Suite 350
Washington, DC 20006
(202) 955-0618
berry@boydengrayassociates.com

Counsel for Applicants
December 17, 2021

EXHIBITS

EXHIBIT 1

RECOMMENDED FOR PUBLICATION
Pursuant to Sixth Circuit I.O.P. 32.1(b)

File Name: 21a0287p.06

UNITED STATES COURT OF APPEALS

FOR THE SIXTH CIRCUIT

IN RE: MCP NO. 165, OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION,
INTERIM FINAL RULE: COVID-19 VACCINATION AND TESTING; EMERGENCY
TEMPORARY STANDARD 86 FED. REG. 61402.
_________________________________________________________________
MASSACHUSETTS BUILDING TRADES COUNCIL, et al. (21-7000); BENTKEY
SERVICES, LLC (21-4027); PHILLIPS MANUFACTURING & TOWER COMPANY, et
al. (21-4028); COMMONWEALTH OF KENTUCKY, et al. (21-4031); ANSWERS IN
GENESIS, INC. (21-4032); SOUTHERN BAPTIST THEOLOGICAL SEMINARY, et al.
(21-4033); BST HOLDINGS, LLC, et al. (21-4080); REPUBLICAN NATIONAL
COMMITTEE (21-4082); ASSOCIATED BUILDERS AND CONTRACTORS, INC., et al.
(21-4083); MASSACHUSETTS BUILDING TRADES COUNCIL (21-4084); UNION OF
AMERICAN PHYSICIANS AND DENTISTS (21-4085); ASSOCIATED GENERAL
CONTRACTORS OF AMERICA, INC., et al. (21-4086); NATIONAL ASSOCIATION OF
BROADCAST EMPLOYEES & TECHNICIANS, THE BROADCASTING AND CABLE
TELEVISION WORKERS SECTOR OF THE COMMUNICATIONS WORKERS OF
AMERICA, LOCAL 51, AFL-CIO (21-4087); STATE OF MISSOURI, et al. (21-4088);
UNITED ASSOCIATION OF JOURNEYMEN AND APPRENTICES OF THE PLUMBING
AND PIPE FITTING INDUSTRY OF THE UNITED STATES AND CANADA, AFL-CIO
(21-4089); STATE OF INDIANA (21-4090); TANKCRAFT CORPORATION, et al. (21-
4091); NATIONAL ASSOCIATION OF HOME BUILDERS (21-4092); JOB CREATORS
NETWORK, et al. (21-4093); UNITED FOOD AND COMMERCIAL WORKERS
INTERNATIONAL UNION, AFL/CIO-CLC, et al. (21-4094); SERVICE EMPLOYEES
INTERNATIONAL UNION LOCAL 32BJ (21-4095); MFA, INC., et al. (21-4096);
STATE OF FLORIDA, et al. (21-4097); AFT PENNSYLVANIA (21-4099); DENVER
NEWSPAPER GUILD, COMMUNICATIONS WORKERS OF AMERICA, LOCAL 37074,
AFL-CIO (21-4100); DTN STAFFING, INC., et al. (21-4101); FABARC STEEL
SUPPLY, INC., et al. (21-4102); MEDIA GUILD OF THE WEST, THE NEWS GUILD-
COMMUNICATIONS WORKERS OF AMERICA, AFL-CIO, LOCAL 39213 (21-4103);
NATURAL PRODUCTS ASSOCIATION (21-4108); OBERG INDUSTRIES, LLC (21-
4112); BETTEN CHEVROLET, INC. (21-4114); TORE SAYS LLC (21-4115);
KENTUCKY PETROLEUM MARKETERS ASSOCIATION, et al. (21-4117); AARON
ABADI (21-4133),
Petitioners,

v.
UNITED STATES DEPARTMENT OF LABOR, OCCUPATIONAL SAFETY AND HEALTH
ADMINISTRATION, et al.,
Respondents.
ŉ
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
Ň
ŋ

Nos. 21-7000
/4027 /4028 /4031
/4032 /4033 /4080
/4082 /4083 /4084
/4085 /4086 /4087
/4089 /4088 /4090
/4091 /4093 /4092
/4095 /4094 /4096
/4097 /4099 /4100
/4101 /4102 /4103
/4108 /4112 /4114
/4115 /4117 /4133
>
Case: 21-7000 Document: 386-2 Filed: 12/17/2021 Page: 1

Nos. 21-7000, et al.
In re: MCP No. 165, Occupational Safety &
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
Page 2

On Emergency Motion to Dissolve Stay.
Multi-Circuit Petitions for Review from an Order of the U.S. Department of Labor,
Occupational Safety and Health Administration, No. OSHA-2001-0007.

Decided and Filed: December 17, 2021
Before: GIBBONS, STRANCH, and LARSEN, Circuit Judges.
_________________
COUNSEL
ON EMERGENCY MOTION TO DISSOLVE STAY AND REPLY: Sarah E. Harrington,
Michael S. Raab, Adam C. Jed, Brian J. Springer, Martin Totaro, UNITED STATES
DEPARTMENT OF JUSTICE, Washington, D.C., for Respondents. IN RESPONSE: R. Trent
McCotter, BOYDEN GRAY & ASSOCIATES, Washington, D.C., for Job Creators Network
Petitioners. Felicia K. Watson, NATIONAL ASSOCIATION OF HOME BUILDERS OF THE
UNITED STATES, Washington, D.C., for Petitioner National Association of Home Builders of
the United States. Christopher Wiest, CHRIS WIEST, ATTORNEY AT LAW, PLLC,
Crestview Hills, Kentucky, for Petitioner Betten Chevrolet, Inc. Harold Craig Becker,
AMERICAN
FEDERATION
OF
LABOR
AND
CONGRESS
OF
INDUSTRIAL
ORGANIZATIONS, Washington, D.C., Peter J. Ford, UNITED FOOD & COMMERCIAL
WORKERS INTERNATIONAL UNION, Washington, D.C., Randy Rabinowitz, OSH LAW
PROJECT, LLC, Washington, D.C., Andrew D. Roth, BREDHOFF & KAISER, PLLC,
Washington, D.C., Nicole Berner, SERVICE EMPLOYEES INTERNATIONAL UNION,
Washington, D.C., Keith R. Bolek, O’DONOGHUE & O’DONOGHUE LLP, Washington, D.C.,
Victoria L. Bor, SHERMAN DUNN, P.C., Washington, D.C., for Petitioner Union of American
Physicians and Dentists. Cathleen A. Martin, John A. Ruth, NEWMAN, COMLEY & RUTH,
P.C., Jefferson City, Missouri, for MFA Incorporated Petitioners. Benjamin M. Flowers, May
Davis, OFFICE OF THE OHIO ATTORNEY GENERAL, Columbus, Ohio, Christopher L.
Thacker, Lindsey R. Keiser, OFFICE OF THE KENTUCKY ATTORNEY GENERAL,
Frankfort, Kentucky, Clark L. Hildabrand, Brandon J. Smith, OFFICE OF THE TENNESSEE
ATTORNEY GENERAL, Nashville, Tennessee, Brian Kane, Leslie M. Hayes, Megan A.
Larrondo, OFFICE OF THE IDAHO ATTORNEY GENERAL, Boise, Idaho, Jeffrey A.
Chanay, OFFICE OF THE KANSAS ATTORNEY GENERAL, Topeka, Kansas, Mithun
Mansinghani, OFFICE OF THE OKLAHOMA ATTORNEY GENERAL, Oklahoma City,
Oklahoma, Lindsay S. See, OFFICE OF THE WEST VIRGINIA ATTORNEY GENERAL,
Charleston, West Virginia, Edmund G. LaCour Jr., OFFICE OF THE ALABAMA ATTORNEY
GENERAL, Montgomery, Alabama, Charles E. Brasington, OFFICE OF THE ALASKA
ATTORNEY GENERAL, Anchorage, Alaska, Drew C. Ensign, OFFICE OF THE ARIZONA
ATTORNEY GENERAL, Phoenix, Arizona, D. John Sauer, OFFICE OF THE MISSOURI
ATTORNEY GENERAL, Jefferson City, Missouri, David M. S. Dewhirst, Christian B.
Corrigan, OFFICE OF THE MONTANA ATTORNEY GENERAL, Helena, Montana, Nicholas
J. Bronni, Vincent M. Wagner, OFFICE OF THE ARKANSAS ATTORNEY GENERAL, Little
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Rock, Arkansas, Henry C. Whitaker, Jason H. Hilborn, OFFICE OF THE FLORIDA
ATTORNEY GENERAL, Tallahassee, Florida, James A. Campbell, OFFICE OF THE
NEBRASKA ATTORNEY GENERAL, Lincoln, Nebraska, Anthony J. Galdieri, OFFICE OF
THE NEW HAMPSHIRE ATTORNEY GENERAL, Concord, New Hampshire, Matthew A.
Sagsveen, OFFICE OF THE NORTH DAKOTA ATTORNEY GENERAL, Bismarck, North
Dakota, Ross W. Bergethon, OFFICE OF THE GEORGIA ATTORNEY GENERAL, Atlanta,
Georgia, Thomas M. Fisher, OFFICE OF THE INDIANA ATTORNEY GENERAL,
Indianapolis, Indiana, Thomas T. Hydrick, OFFICE OF THE SOUTH CAROLINA
ATTORNEY GENERAL, Columbia, South Carolina, Samuel P. Langholz, OFFICE OF THE
IOWA ATTORNEY GENERAL, Des Moines, Iowa, Elizabeth B. Murrill, OFFICE OF THE
LOUISIANA ATTORNEY GENERAL, Baton Rouge, Louisiana, Judd E. Stone II, William F.
Cole, Ryan S. Baasch, OFFICE OF THE TEXAS ATTORNEY GENERAL, Austin, Texas,
Melissa A. Holyoak, OFFICE OF THE UTAH ATTORNEY GENERAL, Salt Lake City, Utah,
John V. Coghlan, OFFICE OF THE MISSISSIPPI ATTORNEY GENERAL, Jackson,
Mississippi, Ryan Schelhaas, OFFICE OF THE WYOMING ATTORNEY GENERAL,
Cheyenne, Wyoming, for State Petitioners. Michael E. Toner, Thomas M. Johnson, Jr., Stephen
J. Obermeier, Jeremy J. Broggi, Krystal B. Swendsboe, WILEY REIN LLP, Washington, D.C.,
for Petitioner Republican National Committee. Daniel P. Lennington, WISCONSIN
INSTITUTE FOR LAW & LIBERTY, Milwaukee, Wisconsin, for Tankcraft Petitioners.
Matthew R. Miller, Robert Henneke, Chance Weldon, Nathan Curtisi, TEXAS PUBLIC
POLICY FOUNDATION, Austin, Texas, for Burnett Specialists Petitioners. John Stone
Campbell III, John P. Murrill, TAYLOR, PORTER, BROOKS, & PHILLIPS L.L.P., Baton
Rouge, Louisiana, for Cox Operating Petitioners. Jessica Hart Steinmann, Josh Campbell,
Rachel Jag, AMERICA FIRST POLICY INSTITUTE, Washington, D.C., Kris W. Kobach,
ALLIANCE FOR FREE CITIZENS, Lecompton, Kansas, for DTN Staffing Petitioners. Daniel
R. Suhr, M. E. Buck Dougherty III, LIBERTY JUSTICE CENTER, Chicago, Illinois, Sarah
Harbison, PELICAN INSTITUTE FOR PUBLIC POLICY, New Orleans, Louisiana, for BST
Holdings Petitioners. Kurtis T. Wilder, Joseph E. Richotte, Steven R. Eatherly, BUTZEL
LONG, P.C., Detroit, Michigan, for Petitioner Small Business Association of Michigan. Henry
M. Perlowski, Ashley S. Kelly, ARNALL GOLDEN GREGORY LLP, Atlanta, Georgia,
Richard J. Oparil, ARNALL GOLDEN GREGORY LLP, Washington, D.C., for Petitioner
Natural Products Association. Robert Alt, THE BUCKEYE INSTITUTE, Columbus, Ohio,
Patrick Strawbridge, CONSOVOY MCCARTHY PLLC, Boston, Massachusetts, for Petitioner
Phillips Manufacturing & Tower Company. David A. Cortman, John J. Bursch, Matthew S.
Bowman, Frank H. Chang, ALLIANCE DEFENDING FREEDOM, Washington, D.C., Ryan L.
Bangert, Ryan J. Tucker, ALLIANCE DEFENDING FREEDOM, Scottsdale, Arizona, for
Southern Baptist Theological Seminary Petitioners. Jordan A. Sekulow, Abigail A. Southerland,
Miles Terry, Christy Stierhoff, AMERICAN CENTER FOR LAW & JUSTICE, Washington,
D.C., Edward L. White III, AMERICAN CENTER FOR LAW & JUSTICE, Ann Arbor,
Michigan, for Petitioner Heritage Foundation. Steven P. Lehotsky, Scott A. Keller, Michael B.
Schon, LEHOTSKY KELLER LLP, Washington, D.C., for Business Association Petitioners.
Matthew J. Clark, ALABAMA CENTER FOR LAW AND LIBERTY, Birmingham, Alabama,
for FabArc Steel Supply Petitioners. J. Larry Stine, WIMBERLY, LAWSON, STECKEL,
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SCHNEIDER & STINE, P.C., Atlanta, Georgia, for Associated Builders and Contractors
Petitioners. Jeffrey C. Mateer, Hiram S. Sasser III, David J. Hacker, Jeremiah G. Dys, Lea E.
Patterson, Keisha T. Russell, FIRST LIBERTY INSTITUTE, Plano, Texas, for Answers in
Genesis Petitioners. David A. Cortman, John J. Bursch, Matthew S. Bowman, Frank H. Chang,
ALLIANCE DEFENDING FREEDOM, Washington, D.C., Ryan L. Bangert, Ryan J. Tucker,
ALLIANCE DEFENDING FREEDOM, Scottsdale, Arizona, Harmeet K. Dhillon, Ronald D.
Coleman, Mark P. Meuser, Michael A. Columbo, DHILLON LAW GROUP INC., San
Francisco, California, for Petitioner Bentkey Services. Aaron Abadi, New York, New York, pro
se. ON AMICUS BRIEF: Brianne Gorod, CONSTITUTIONAL ACCOUNTABILITY
CENTER, Washington, D.C., Scott E. Rosenow WMC LITIGATION CENTER, Madison,
Wisconsin, Catherine L. Strauss, ICE MILLER LLP, Columbus, Ohio, Sheng Li, NEW CIVIL
LIBERTIES ALLIANCE, Washington, D.C., Emmy L. Levens, COHEN MILSTEIN SELLERS
& TOLL PLLC, Washington, D.C., Rachel L. Fried, Jessica Anne Morton, Jeffrey B. Dubner,
JoAnn Kintz, DEMOCRACY FORWARD FOUNDATION, Washington, D.C., Scott L. Nelson,
Allison M. Zieve, PUBLIC CITIZEN LITIGATION GROUP, Washington, D.C., Michael T.
Anderson, Adam C. Breihan, MURPHY ANDERSON PLLC, Washington, D.C., Deepak Gupta,
GUPTA WESSLER PLLC, Washington, D.C., for Amici Curiae.

STRANCH, J., delivered the opinion of the court in which GIBBONS, J., joined.
GIBBONS, J. (pg. 38), delivered a separate concurring opinion. LARSEN, J. (pp. 39–57),
delivered a separate dissenting opinion.
_________________
OPINION
_________________
JANE B. STRANCH, Circuit Judge. The COVID-19 pandemic has wreaked havoc
across America, leading to the loss of over 800,000 lives, shutting down workplaces and jobs
across the country, and threatening our economy. Throughout, American employees have been
trying to survive financially and hoping to find a way to return to their jobs. Despite access to
vaccines and better testing, however, the virus rages on, mutating into different variants, and
posing new risks. Recognizing that the “old normal” is not going to return, employers and
employees have sought new models for a workplace that will protect the safety and health of
employees who earn their living there. In need of guidance on how to protect their employees
from COVID-19 transmission while reopening business, employers turned to the Occupational
Safety and Health Administration (OSHA or the Agency), the federal agency tasked with
assuring a safe and healthful workplace. On November 5, 2021, OSHA issued an Emergency
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Temporary Standard (ETS or the standard) to protect the health of employees by mitigating
spread of this historically unprecedented virus in the workplace. The ETS requires that
employees be vaccinated or wear a protective face covering and take weekly tests but allows
employers to choose the policy implementing those requirements that is best suited to their
workplace. The next day, the U.S. Court of Appeals for the Fifth Circuit stayed the ETS pending
judicial review, and it renewed that decision in an opinion issued on November 12. Under
28 U.S.C. § 2112(a)(3), petitions challenging the ETS—filed in Circuits across the nation—were
consolidated into this court. Pursuant to our authority under 28 U.S.C. § 2112(a)(4), we
DISSOLVE the stay issued by the Fifth Circuit for the following reasons.
I. BACKGROUND
A. OSHA’s History and Authority
Congress passed the Occupational Safety and Health Act of 1970 (OSH Act or the Act)
and established OSHA “to assure safe and healthful working conditions for the nation’s work
force and to preserve the nation’s human resources.” Asbestos Info. Ass’n/N. Am. v.
Occupational Safety & Health Admin., 727 F.2d 415, 417 (5th Cir. 1984). It expressly found that
“personal injuries and illnesses arising out of work situations impose a substantial burden upon,
and are a hindrance to, interstate commerce in terms of lost production, wage loss, medical
expenses, and disability compensation payments.” 29 U.S.C. § 651(a). OSHA is charged with
ensuring worker safety and health “by developing innovative methods, techniques, and
approaches for dealing with occupational safety and health problems.” Id. § 651(b)(5). To fulfill
that charge, Congress authorized the Secretary of Labor (the Secretary) “to set mandatory
occupational safety and health standards applicable to businesses affecting interstate commerce.”
Id. § 651(b)(3). And it vested the Secretary with “broad authority . . . to promulgate different
kinds of standards” for health and safety in the workplace. Indus. Union Dep’t, AFL-CIO v. Am.
Petroleum Inst., 448 U.S. 607, 611 (1980) (plurality opinion); see, e.g., N. Am.’s Bldg. Trades
Unions v. Occupational Safety & Health Admin., 878 F.3d 271, 281 (D.C. Cir. 2017); United
Steelworkers of Am., AFL-CIO-CLC v. Marshall, 647 F.2d 1189, 1202, 1311 (D.C. Cir. 1980);
29 C.F.R. §§ 1910.141, 1926.51.
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An occupational safety and health standard is one that “requires conditions, or the
adoption or use of one or more practices, means, methods, operations, or processes, reasonably
necessary or appropriate to provide safe or healthful employment and places of employment.”
29 U.S.C. § 652(8). Before going into effect, OSHA’s standards must undergo a notice-and-
comment period for 30 days, during which time anyone who objects to the standard may request
a public hearing. Id. § 655(b)(2)–(3). Within 60 days from the end of the notice-and-comment
period, the Secretary must either publish the standard or decline to issue the standard. Id.
§ 655(b)(4). The Secretary has set standards that affect workplaces across the country in a wide
range of categories, including sanitation, air contaminants, hazardous materials, personal
protective equipment, and fire protection. See National Consensus Standards and Established
Federal Standards, 36 Fed. Reg. 10,466 (May 29, 1971).
In emergency circumstances, OSHA “shall” promulgate an “emergency temporary
standard” that takes “immediate effect.” 29 U.S.C. § 655(c)(1). Emergency temporary standards
do not displace notice-and-comment requirements; rather, the ETS serves as the “proposed rule,”
and OSHA must proceed over the course of six months with the notice-and-comment procedures
of a normal OSHA standard. Id. § 655(c)(2), (3). At the end of that period, the Secretary must
promulgate either the same standard or a revised standard in light of the notice-and-comment
process. Id. § 655(c)(2). Before issuing an ETS, OSHA must determine: (1) “that employees are
exposed to grave danger from exposure to substances or agents determined to be toxic or
physically harmful or from new hazards,” and (2) that an “emergency standard is necessary to
protect employees from such danger.” Id. § 655(c)(1).
With respect to any OSHA standard—emergency or otherwise—employers may seek a
“variance” from the standard. Id. § 655(d). Under that provision, an employer must demonstrate
“that the conditions, practices, means, methods, operations, or processes used or proposed to be
used by an employer will provide employment and places of employment to his employees
which are as safe and healthful as those which would prevail if he complied with the standard.”
Id.
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B. Factual Background
OSHA monitored the COVID-19 pandemic from the beginning. As early as April 2020,
OSHA sought to protect workers through “widespread voluntary compliance” with “safety
guidelines,” specifying that workplaces should comply with personal protective equipment
standards, see 29 C.F.R. § 1910, and by reinforcing employers’ “general duty” to furnish each
worker “employment and a place of employment, which are free from recognized hazards that
are causing or are likely to cause death or serious physical harm,” see 29 U.S.C. § 654(a)(1).
Given the pandemic’s trajectory—and the emergence of rapidly-spreading variants causing
“increases in infectiousness and transmission,” 86 Fed. Reg. at 61,409—OSHA found that its
“nonregulatory enforcement tools” were “inadequate” to ensure all working individuals “safe
and healthful working conditions.” 29 U.S.C. § 651(b); see 86 Fed. Reg. at 61,410–45.
Determining that the continued spread of COVID-19 met the two requirements of
§ 655(c)(1), on November 5, 2021, OSHA published an ETS to fulfill its statutory directive and
address the “extraordinary and exigent circumstances” presented by this unprecedented
pandemic. 86 Fed. Reg. at 61,434. OSHA published a 153-page preamble to the ETS to explain
the bases for its decision to issue the ETS under 29 U.S.C. § 655(c). See COVID-19 Vaccination
and Testing; Emergency Temporary Standard, 86 Fed. Reg. 61,402 (Nov. 5, 2021) (to be
codified at 29 C.F.R. pts. 1910, 1915, 1917, 1918, 1926, and 1928).
The ETS does not require anyone to be vaccinated. Rather, the ETS allows covered
employers—employers with 100 or more employees—to determine for themselves how best to
minimize the risk of contracting COVID-19 in their workplaces. Id. at 61,438 (allowing
employers to “opt out” of any vaccination policies). Employers have the option to require
unvaccinated workers to wear a mask on the job and test for COVID-19 weekly. Id. They can
also require those workers to do their jobs exclusively from home, and workers who work
exclusively outdoors are exempt. Id. at 61,419. The employer—not OSHA—can require that its
workers get vaccinated, something that countless employers across the country have already
done. Id. at 61,436 (“[T]his ETS offers employers a choice in how to comply . . . .”).
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Employers must also confirm their employees’ vaccination status and keep records of that
status. Id. at 61,552. Consistent with other OSHA standard penalties, employers who fail to
follow the standard may be fined penalties up to $13,653 for each violation and up to $136,532
for each willful violation. 29 C.F.R. § 1903.15(d).
C. Procedural History

Shortly after OSHA issued the ETS, private employers, labor unions, state governments,
and individual citizens across the country filed suit in virtually every circuit court, challenging
OSHA’s authority to issue such an ETS and OSHA’s basis for the ETS. One day after the ETS
went into effect, the Fifth Circuit issued a stay barring OSHA from enforcing the ETS until the
completion of judicial review. BST Holdings, LLC v. Occupational Safety & Health Admin.,
No. 21-60845, 2021 WL 5166656 (5th Cir. Nov. 6, 2021) (per curiam). Less than a week later,
the Fifth Circuit issued a written opinion, reaffirming the initial stay after “having conducted . . .
[an] expedited review.” BST Holdings, LLC v. Occupational Safety & Health Admin., 17 F.4th
604 (5th Cir. 2021).

In reaching its decision to stay the ETS, the Fifth Circuit generally forecasted that the
ETS faced fatal statutory and constitutional issues, then concluded that the Petitioners had
demonstrated a strong likelihood of success on the merits. Id. at 611–18. On the other stay
factors, the Fifth Circuit found that individuals, states, and employers would be “substantially
burdened” due to the compliance costs, loss of constitutional freedom, and intrusion into States’
“constitutionally reserved police power.” Id. at 618. Without addressing any of OSHA’s factual
explanations or its supporting scientific evidence concerning harm, the Fifth Circuit summarily
concluded that “a stay will do OSHA no harm whatsoever” and “a stay is firmly in the public
interest.” Id. at 618–19 (emphasis in original).

Under 28 U.S.C. § 2112(a)(3), the Government notified the judicial panel on multidistrict
litigation of petitions across multiple circuits, invoking the lottery procedure to consolidate all
petitions in a single circuit. On November 16, the panel designated the U.S. Court of Appeals
for the Sixth Circuit to review the petitions. On November 23, the Government moved to
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dissolve the stay issued by the Fifth Circuit pursuant to § 2112(a)(4), which provides that the
court of appeals chosen through the multi-circuit lottery may modify, revoke, or extend a stay
that a court of appeals issued before the lottery.
II. ANALYSIS
Relying primarily on the evidence and authority set out in its 153-page preamble, OSHA
moved to dissolve the Fifth Circuit’s stay. Under 28 U.S.C. § 2112(a)(4), we review de novo the
challenged aspects of the ETS to determine whether the Fifth Circuit’s stay should be modified,
revoked, or extended.
A. Standard for Stay
“A stay is an ‘intrusion into the ordinary processes of administration and judicial
review.’” Nken v. Holder, 556 U.S. 418, 427 (2009) (quoting Va. Petroleum Jobbers Ass’n. v.
Fed. Power Comm’n, 259 F.2d 921, 925 (D.C. Cir. 1958)). Therefore, it “is not a matter of right,
even if irreparable injury might otherwise result to the appellant.” Id. (quoting Virginian Ry. Co.
v. United States, 272 U.S. 658, 672 (1926)). “[T]he heavy burden for making out a case for such
extraordinary relief” rests on “the moving parties.” Winston-Salem/Forsyth Cnty. Bd. of Educ. v.
Scott, 404 U.S. 1221, 1231 (1971); see also Nken, 556 U.S. at 433–34.
To determine whether a stay pending judicial review is merited, we consider four factors:
(1) whether the stay applicant has made a strong showing that he is likely to
succeed on the merits; (2) whether the applicant will be irreparably injured absent
a stay; (3) whether issuance of the stay will substantially injure the other parties
interested in the proceeding; and (4) where the public interest lies.
Nken, 556 U.S. at 426 (quoting Hilton v. Braunskill, 481 U.S. 770, 776 (1987)).
B. Likelihood of Success on the Merits
1. Scope of OSHA’s Statutory Authority
Petitioners’ arguments are primarily grounded in the Fifth Circuit’s blanket conclusion
that the ETS is beyond the scope of OSHA’s statutory authority. The ETS was issued under
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§ 655(c)(1) of the Act, which requires OSHA to issue an emergency standard if necessary to
protect workers from a “grave danger” presented by “exposure to substances or agents
determined to be toxic or physically harmful or from new hazards.” 29 U.S.C. § 655(c)(1). In
assessing that authority, the Fifth Circuit focused solely on the words in § 655(c)(1): “substances
or agents,” “toxic or physically harmful,” and “grave danger,” opining that those words are to be
interpreted based on the words and phrases in the immediate vicinity of the statutory language at
issue. BST Holdings, 17 F.4th at 612–13. But the Supreme Court has instructed that words and
phrases must be viewed in the context of the entire statute. See Gade v. Nat’l Solid Wastes
Mgmt. Ass’n, 505 U.S. 88, 99 (1992) (instructing that, when evaluating a statute, a court “must
not be guided by a single sentence or member of a sentence, but look to the provisions of the
whole law”). We therefore take a holistic view of the language that Congress chose to include in
its statutory authorization to OSHA.
An “agent” is “a chemically, physically, or biologically active principle.” Agent,
Merriam-Webster Collegiate Dictionary, https://unabridged.merriam-webster.com/collegiate/
agent. And a virus is defined, in part, as “any large group of submicroscopic infectious agents.”
Virus, Merriam-Webster Collegiate Dictionary, https://unabridged.merriam-webster.com/
collegiate/virus. The statute requires OSHA to determine whether an agent is “toxic or
physically harmful or from new hazards,” 29 U.S.C. § 655(c)(1) (emphasis added), speaking in
the disjunctive, which specifies that words so connected “are to be given separate meanings,”
Loughrin v. United States, 573 U.S. 351, 357 (2014) (quoting United States v. Woods, 571 U.S.
31, 45–46 (2013)). To conflate two descriptors into one meaning would improperly render one
disjunctive phrase superfluous. See Bailey v. United States, 516 U.S. 137, 146 (1995); Reiter v.
Sonotone Corp., 442 U.S. 330, 338–39 (1979). Under the statutory definition, any agent,
including a virus, that is either “toxic” (i.e., poisonous, toxicity) or “physically harmful” (i.e.,
causing bodily harm) falls within OSHA’s purview. An agent that causes bodily harm—a
virus—falls squarely within the scope of that definition.

Other provisions of the Act reinforce OSHA’s authority to regulate infectious diseases
and viruses. As explained above, Congress enacted the OSH Act under the Commerce Clause
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because Congress found that “illnesses arising out of work situations impose a substantial burden
upon . . . interstate commerce.” 29 U.S.C § 651(a) (emphasis added). Congress created the
safety and health administration to protect workers from those illnesses by reducing “health
hazards at their places of employment.” Id. § 651(b)(1). The Act’s objectives include exploring
“ways to discover latent diseases, establishing causal connections between diseases and work in
environmental conditions, and conducting other research relating to health problems . . . .” Id.
§ 651(b)(6). And finally, the Act sought to “provid[e] medical criteria which will assure insofar
as practicable that no employee will suffer diminished health, functional capacity, or life
expectancy as a result of his work experience.” Id. § 651(b)(7).

Section 20 of the OSH Act provides for OSHA to work with and through other agencies
by expressly directing the Secretary of Health and Human Services to conduct research in
consultation with the Secretary of Labor to develop “information regarding potentially toxic
substances or harmful physical agents,” including through medical examination and tests. Id.
§ 669(a)(5). That provision also contains the religious exemption for the entire OSH Act:
“[n]othing in this or any other provision of this chapter shall be deemed to authorize or require
medical examination, immunization, or treatment, for those who object thereto on religious
grounds, except where such is necessary for the protection of the health or safety of others.” Id.
The provision’s reference to immunization and its creation of a limited exception to the Act’s
authorization of standards involving immunization would be rendered meaningless if the statute
did not contemplate both that “harmful agents” include infectious, disease-causing agents, such
as viruses, and that OSHA would employ the use of immunizations to combat those agents.
Congress confirmed OSHA’s infectious disease authority in other statutes. In 1989,
OSHA proposed a standard governing bloodborne pathogens to curb transmission rates of HIV,
hepatitis B (HBV), and hepatitis C. See Occupational Exposure to Bloodborne Pathogens,
54 Fed. Reg. 23,042 (proposed May 30, 1989). When the standard had not been finalized by
1991, Congress ordered OSHA to finalize its rulemaking by a date certain, “warning that if
[OSHA] did not meet its deadline, the proposed standard would become effective in the interim.”
Dale and Tracy, Occupational Safety and Health Law 64 (2018). In 1992, Congress passed the
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Workers Family Protection Act, codified in 29 U.S.C. § 671a, the same U.S. Code chapter as the
OSH Act. The statute resulted from findings that “hazardous chemicals and substances” were
being transported home on workers and their clothing posing a “threat to the health and welfare
of workers and their families.” 29 U.S.C. § 671a(b)(1)(A)–(B). Section 671a requires the
National Institute for Occupational Safety and Health to work with OSHA to study “issues
related to the contamination of workers’ homes with hazardous chemicals and substances,
including infectious agents, transported from the workplaces of such workers.” Id.
§ 671a(c)(1)(A) (emphasis added). OSHA is then specifically required to consider the need for
additional standards on the studied issues and to promulgate such standards “pursuant to . . . the
Occupational Safety and Health Act of 1970.” Id. § 671a(d)(2).
In 2000, Congress passed the Needlestick Safety and Prevention Act, directing OSHA to
strengthen its bloodborne pathogens standard and provide language for the regulatory text. Pub.
L. No. 106-430, 114 Stat. 1901 (2000). Although legal challenges were brought against the
standard, no party challenged OSHA’s authority to regulate bloodborne pathogens. See Am.
Dental Ass’n v. Martin, 984 F.2d 823, 826 (7th Cir. 1993). Removing any basis for doubt that
OSHA is authorized to regulate infectious diseases, Congress expressly included funding for
OSHA in the American Rescue Plan that is to be used “to carry out COVID-19 related worker
protection activities.” Pub. L. No. 117-2, § 2101, 135 Stat. 4, 30 (2021).

Based on the OSH Act’s language, structure, and Congressional approval, OSHA has
long asserted its authority to protect workers against infectious diseases. In 1991, it promulgated
a standard regarding exposure to bloodborne pathogens. Occupational Exposure to Bloodborne
Pathogens; Final Rule; 56 Fed. Reg. 64,004 (1991) (codified at 29 C.F.R. § 1910.1030). That
standard required employers to make the hepatitis B vaccine available to employees at risk of
exposure to HBV. 29 C.F.R. § 1910.1030(f). OSHA has also promulgated standards requiring
employers engaged in hazardous waste cleanup to protect against any “biological agent and other
disease-causing agent” that “upon exposure, ingestion, inhalation or assimilation into any
person,. . . will or may reasonably be anticipated to cause death [or] disease,” id.
§ 1910.120(a)(3); requiring use of respirators to prevent occupational diseases caused by
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“harmful dusts, fogs, fumes, mists, gases, smokes, sprays, or vapors,” id. § 1910.134(a)(1); and
requiring employers to provide adequate toilet and handwashing facilities to protect workers
from pesticides and prevent the spread of harmful bacteria and disease, id. § 1910.141; see also
Field Sanitation, 52 Fed. Reg. 16,050, 16,087, 16,090–91 (May 1, 1987) (codified at 29 C.F.R.
§ 1928.110) (requiring construction employers to ban the use of common drinking cups to avoid
the risk of contracting diseases); 29 C.F.R. § 192.51(a)(4).

Given OSHA’s clear and exercised authority to regulate viruses, OSHA necessarily has
the authority to regulate infectious diseases that are not unique to the workplace. Indeed, no
virus—HIV, HBV, COVID-19—is unique to the workplace and affects only workers. And
courts have upheld OSHA’s authority to regulate hazards that co-exist in the workplace and in
society but are at heightened risk in the workplace. See, e.g., Forging Indus. Ass’n v. Sec’y of
Labor, 773 F.2d 1436, 1442–43 (4th Cir. 1985) (en banc) (rejecting the argument that “because
hearing loss may be sustained as a result of activities which take place outside the workplace . . .
OSHA acted beyond its statutory authority by regulating non-occupational conditions or
causes”); Am. Dental Ass’n, 984 F.2d at 826 (recognizing that the “infectious character of HIV
and HBV warrant[s] even on narrowly economic grounds more regulation than would be
necessary in the case of a noncommunicable disease”); see also 29 C.F.R. § 1910.1025 (OSHA
regulates workplace exposure to lead).

Longstanding precedent addressing the plain language of the Act, OSHA’s interpretations
of the statute, and examples of direct Congressional authorization following the enactment of the
OSH Act all show that OSHA’s authority includes protection against infectious diseases that
present a significant risk in the workplace, without regard to exposure to that same hazard in
some form outside the workplace.
The responsibility the Act imposes on OSHA to protect the safety and health of
employees, moreover, is hardly limited to “hard hats and safety goggles.” OSHA has wide
discretion to form and implement the best possible solution to ensure the health and safety of all
workers, and has historically exercised that discretion. See United Steelworkers of Am., 647 F.2d
at 1260. Having been charged by the Act with creating such health-based standards, it makes
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sense that OSHA’s authority contemplates the use of medical exams and vaccinations as tools in
its arsenal. See id. at 1228–40 (concluding that OSHA has the authority to require medical
surveillance of lead levels). “To suggest otherwise would mean that Congress had to have
anticipated both the unprecedented COVID-19 pandemic and the unprecedented politicization of
the disease to regulate vaccination against it.” Florida v. Dep’t of Health & Hum. Servs., No.
21-14098-JJ, 2021 WL 5768796, at *12 (11th Cir. Dec. 6, 2021). No such prescience is required
to address the health and safety concerns of American workers as they seek to return to their
workplaces. The language of the OSH Act plainly authorizes OSHA to act on its charge “to
assure safe and healthful working conditions for the nation’s work force and to preserve the
nation’s human resources.” Asbestos Info. Ass’n, 727 F.2d at 417.
2. Major Questions Doctrine
Having established OSHA’s statutory authority, we pause to address Petitioners’ and the
Fifth Circuit’s arguments pertaining to the major questions doctrine. The Fifth Circuit’s
complete discussion of the point is contained in a single paragraph:
[T]he major questions doctrine confirms that the Mandate exceeds the bounds of
OSHA’s statutory authority. Congress must “speak clearly if it wishes to assign
to an agency decisions of vast economic and political significance.” The Mandate
derives its authority from an old statute employed in a novel manner, imposes
nearly $3 billion in compliance costs, involves broad medical considerations that
lie outside of OSHA’s core competencies, and purports to definitively resolve one
of today’s most hotly debated political issues. There is no clear expression of
congressional intent in § 655(c) to convey OSHA such broad authority, and this
court will not infer one. Nor can the Article II executive breathe new power into
OSHA’s authority—no matter how thin patience wears.
BST Holdings, 17 F.4th at 617–18 (citations and footnote omitted) (quoting Util. Air Regul. Grp.
v. EPA, 573 U.S. 302, 324 (2014)).
The seldom-used major questions doctrine is a canon of statutory interpretation that has
been described as an exception to Chevron deference. See, e.g., King v. Burwell, 576 U.S. 473,
485–86 (2015). If any agency’s regulatory action “bring[s] about an enormous and
transformative expansion in [the agency’s] regulatory authority,” then there must be “clear
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congressional authorization.” Util. Air Regul. Grp., 573 U.S. at 324. “We expect Congress to
speak clearly if it wishes to assign to an agency decisions of vast ‘economic and political
significance.’” Id. (quoting FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 160
(2000)). The doctrine itself is hardly a model of clarity, and its precise contours—specifically,
what constitutes a question concerning deep economic and political significance—remain
undefined.
The major questions doctrine is inapplicable here, however, because OSHA’s issuance of
the ETS is not an enormous expansion of its regulatory authority. OSHA has regulated
workplace health and safety on a national scale since 1970, including controlling the spread of
disease. See Am. Textile Mfrs. Inst. v. Donovan, 452 U.S. 490, 520 (1981). As cataloged at
length above, vaccination and medical examinations are both tools that OSHA historically
employed to contain illness in the workplace. The ETS is not a novel expansion of OSHA’s
power; it is an existing application of authority to a novel and dangerous worldwide pandemic.
The dissent assumes our conclusion rests on the length of time (since 1970) OSHA has
regulated workplaces and that we miss the point that the major questions doctrine is also about
the “scope or degree” of the power an agency wields. (Dissent Op. at 53) Our conclusion rests
on much more, including: An extensive catalog of OSHA’s regulatory authority, citing the text
of the Act and precedent, both replete with references that contemplate the authority OSHA uses
here; the actual components of OSHA’s work—such as its many years of regulating illness in the
workplace; and other statutes acknowledging OSHA’s authority, including one that expressly
allocates funding to OSHA for its intervention in the COVID-19 crisis. This listing shows that
OSHA was granted the authority that it exercised. The case cited by the dissent, FDA v. Brown
& Williamson Tobacco Corporation, is inapposite because there the FDA made the claim that its
authority to regulate “drugs” extended to cigarettes, but Congress had repeatedly declined to
grant the FDA that authority. See 529 U.S. at 125, 137–39.
Any doubt as to OSHA’s authority is assuaged by the language of the OSH Act. In
arguing that OSHA does not have this authority, Petitioners and the Fifth Circuit rely on the
Supreme Court’s and the Sixth Circuit’s recent cases invoking the major questions doctrine
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regarding a nationwide moratorium on evictions in counties experiencing high levels of COVID-
19 transmission. See Ala. Ass’n of Realtors v. U.S. Dep’t of Health & Hum. Servs., 141 S. Ct.
2485 (2021); Tiger Lily, LLC v. U.S. Dep’t of Hous. & Urb. Dev., 5 F.4th 666 (6th Cir. 2021).
The Centers for Disease Control and Prevention (CDC) promulgated the moratorium under
§ 361(a) of the Public Health Service Act (PHSA), referencing its “broad authority to take
whatever measures it deems necessary to control the spread of COVID-19.” Ala. Ass’n of
Realtors, 141 S. Ct. at 2488. The Supreme Court determined that clear language in the PHSA
expressly limited the scope of the CDC’s authority to specific measures, which scope did not
include moratoria. Id. The Court noted that “[e]ven if the text were ambiguous, the sheer scope
of the CDC’s claimed authority under § 361(a) would counsel against the Government’s agency
interpretation.” Id. at 2489. Because 80 percent of the United States population fell within the
moratorium, which would cost nearly $50 billion, and the moratorium intruded into an area
traditionally left to the States, landlord-tenant law, the Court noted that if Congress wished the
CDC to have such authority, it needed to “enact exceedingly clear language” to that effect. Id.
(quoting U.S. Forest Serv. v. Cowpasture River Pres. Ass’n, 140 S. Ct. 1837, 1850 (2020)).
As an initial point, Alabama Association of Realtors and Tiger Lily do not control this
case. Those cases concerned a different agency, the CDC, and a different regulation, the
suspension of evictions. Any authority to issue such regulation came from a different statute:
the PHSA. The decisions primarily focused on interpreting the language of that underlying
statute. Ala Ass’n of Realtors, 141 S. Ct. at 2488; Tiger Lily, 5 F.4th at 669–71.
Those cases are inapposite because here the statutory language unambiguously grants
OSHA authority for the ETS. As discussed at length, the OSH Act confers authority on OSHA
to impose standards and regulations on employers to protect workplace health and safety,
including the transmission of viruses in the workplace. See 29 U.S.C. §§ 651(b), 655(c).
OSHA’s ETS authority is circumscribed not only by the requirements of grave danger and
necessity, but also by the required relationship to the workplace. Id.; see United Steelworkers of
Am., 647 F.2d at 1230. And OSHA honored those parameters, issuing emergency standards only
eleven times, including the currently challenged ETS. See SCOTT D. SZYMENDRA, CONG. RSCH.
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SERV., R46288, OCCUPATION SAFETY AND HEALTH ADMIN. (OSHA): COVID-19 EMERGENCY
TEMPORARY STANDARDS (ETS) ON HEALTH CARE EMP. AND VACCINATIONS AND TESTING FOR
LARGE EMPS. at 35–36 tbl. A-1 (2021), https://crsreports.congress.gov/product/pdf/R/R46288.
This is, therefore, different from the CDC’s authority under the PHSA, which provided a limited
scope of tools to effectuate the Act’s purposes, which scope did not include moratoria, and which
regulated an area not traditionally in the CDC’s wheelhouse.1 Finally, the same federalism
concerns are not at issue here: “[a]lthough . . . ‘public health issues’ . . . have ‘traditionally been
a primary concern of state and local officials,’ Congress, in adopting the OSH Act, decided that
the federal government would take the lead in regulating the field of occupational health.”
Farmworker Just. Fund v. Brock, 811 F.2d 613, 625 (D.C. Cir. 1987) (quoting Am. Textile Mfrs.
Inst., 452 U.S. at 509).
In sum, the major questions doctrine is inapplicable here. OSHA’s issuance of the ETS is
not a transformative expansion of its regulatory power as OSHA has regulated workplace health
and safety, including diseases, for decades.
3. OSHA’s Basis for the Emergency Temporary Standard
Having found no threshold issue that OSHA exceeded its authority under the statute, we
turn to the challenges to the ETS itself.
As noted, OSHA is permitted to issue an emergency temporary standard, which takes
“immediate effect” and serves as a “proposed rule” for a notice-and-comment rulemaking if it
determines: (1) “that employees are exposed to grave danger from exposure to substances or
agents determined to be toxic or physically harmful or from new hazards,” and (2) that a
standard “is necessary to protect employees from such danger.” 29 U.S.C. § 655(c). Those
determinations are “conclusive if supported by substantial evidence in the record as a whole.”

1In comparing this case with Alabama Association, the Fifth Circuit wrote, “But health agencies do not
make housing policy, and occupational safety administrators do not make health policy.” BST Holdings, 17 F.4th at
619. The Fifth Circuit fails to acknowledge that OSHA stands for the Occupational Safety and Health
Administration. See 29 U.S.C. § 651(b) (“The Congress declares it to be its purpose and policy . . . to assure so far
as possible every working man and woman in the Nation safe and healthful working conditions . . . .” (emphasis
added)).
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Id. § 655(f). On judicial review, we determine “whether the record contains ‘such relevant
evidence as a reasonable mind might accept as adequate to support a conclusion.’” Asbestos
Info. Ass’n, 727 F.2d at 421 (quoting Consol. Edison Co. v. NLRB, 305 U.S. 197, 229 (1938)).
While the ultimate question hinges on whether the record contains substantial evidence,
“the nature of the evidence in this case requires that we inquire into whether OSHA ‘carried out
[its] essentially legislative task in a manner reasonable under the state of the record before [it].’”
Id. at 421 (quoting Aqua Slide ‘n’ Dive Corp. v. Consumer Prod. Safety Comm’n, 569 F.2d 831,
838 (5th Cir. 1978)). To this end, deference is given to OSHA’s fact-finding expertise. Id.
(citing Aqua Slide ‘n’ Dive Corp., 569 F.2d at 838). While “we must take a ‘harder look’ at
OSHA’s action than we would if we were reviewing the action under the more deferential
arbitrary and capricious standard,” id. at 421, by the very nature of the administrative
proceeding, some flexibility is to be exercised in judicial review, id. at 422.
The court “can review [the] data in the record and determine whether it reflects
substantial support for the Secretary’s findings.” Indus. Union Dep’t, AFL-CIO v. Hodgson,
499 F.2d 467, 475 (D.C. Cir. 1974) (recognizing that substantial evidence standard of review in a
legislative-type proceeding is only applicable to some dimensions of the agency’s decision). But
some “determinations involve policy choices or factual determinations so much ‘on the frontiers
of scientific knowledge’ that they resemble policy determinations more than factual ones.”
Asbestos Info. Ass’n, 727 F.2d at 422 (quoting Hodgson, 499 F.2d at 474). For these
determinations we respect “‘the boundaries between the legislative and the judicial function,’
[and] we ‘approach our reviewing task with a flexibility informed and shaped by sensitivity to
the diverse origins of the determinations that enter into a legislative judgment’ made by an
agency.” Id. (quoting Hodgson, 499 F.2d at 475). So too here.
In assessing the likelihood of success of the ETS challenges, we rely on the extensive
preamble to the ETS and the record before the courts.
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i. Emergency
We begin with the contention endorsed by the Fifth Circuit that the standard
automatically fails because OSHA did not issue the ETS at the outset of the pandemic. The
claim that COVID-19 does not present “a true emergency” in the workplace has no foundation in
the record and law and ignores OSHA’s explanations. OSHA addressed COVID-19 in
progressive steps tailored to the stage of the pandemic, including consideration of the growing
and changing virus, the nature of the industries and workplaces involved, and the availability of
effective tools to address the virus. This reasoned policy determination does not undermine the
state of emergency that this unprecedented pandemic currently presents.
Even if we assume that OSHA should have issued an ETS earlier, moreover, “to hold that
because OSHA did not act previously it cannot do so now only compounds the consequences of
the Agency’s failure to act.” Id. at 423. In Asbestos Information Association, the petitioners
challenged the Agency’s motives in promulgating an ETS “when the Agency has known for
years that asbestos constitutes a serious health risk, and, in fact, has had all the data it uses to
support its . . . action at hand, but nevertheless failed to act on it.” Id. The Fifth Circuit
concluded that the statutory language itself precludes a requirement that OSHA may only act on
“new information” because the Act permits regulation of harmful agents or “new hazards,”
proving that not all regulated dangers must be new. Id. “OSHA should, of course, offer some
explanation for its timing in promulgating an ETS,” id., and OSHA has done so here.
The record establishes that COVID-19 has continued to spread, mutate, kill, and block
the safe return of American workers to their jobs. To protect workers, OSHA can and must be
able to respond to dangers as they evolve. As OSHA concluded: with more employees returning
to the workplace, the “rapid rise to predominance of the Delta variant” meant “increases in
infectiousness and transmission” and “potentially more severe health effects.” 86 Fed. Reg. at
61,409–12. OSHA also explained that its traditional nonregulatory options had been proven
“inadequate.” Id. at 61,444. OSHA acted within its discretion in making the practical decision
to wait for Federal Drug Administration (FDA) approval of the vaccines before issuing the ETS;
“this fact demonstrates appropriate caution and thought on the part of the Secretary.”
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Florida, 2021 WL 5768796, at *14 n.2. These findings, therefore, coupled with FDA-approved
vaccines, more widespread testing capabilities, the recognized Delta variant and the possibility of
new variants2 support OSHA’s conclusion that the current situation is an emergency, and one
that can be ameliorated by agency action.
ii. Grave Danger
Health effects may constitute a “grave danger” under the OSH Act if workers face “the
danger of incurable, permanent, or fatal consequences . . . , as opposed to easily curable and
fleeting effects on their health.” Fla. Peach Growers Ass’n, Inc. v. U.S. Dep’t of Labor,
489 F.2d 120, 132 (5th Cir. 1974). The “grave danger” required to warrant an ETS is a risk
greater than the “significant risk” that OSHA must show to promulgate a permanent standard
under § 655(b) of the Act. See Indus. Union Dep’t, 448 U.S. at 640 n.45. But the ultimate
determination of what precise level of risk constitutes a “grave danger” is a “policy consideration
that belongs, in the first instance, to the Agency.” Asbestos Info. Ass’n, 727 F.2d at 425
(accepting OSHA’s determination that 80 lives at risk over six months was a grave danger).
The Fifth Circuit’s conclusion, unadorned by precedent, that OSHA is “required to make
findings of exposure—or at least the presence of COVID-19—in all covered workplaces” is
simply wrong. BST Holdings, 17 F.4th at 613 (emphasis in original). If that were true, no
hazard could ever rise to the level of “grave danger” because a risk cannot exist equally in every
workplace and so the entire provision would be meaningless. Almost fifty years ago, the Third
Circuit quickly dismantled this argument:
Industry petitioners argue that there must also be substantial evidence to support
OSHA’s determination that employees are in fact being exposed to those harmful
substances. Although subsection 6(c)(1) readily lends itself to such a reading, that
interpretation would render ineffective the provision for emergency temporary
standards. The purpose of subsection 6(c)(1) is to provide immediate protection
in cases where there is a grave danger of harm to employees. This necessarily
requires rather sweeping regulation. OSHA cannot be expected to conduct
on-the-spot investigations of every user to determine if exposure is occurring.

2This possibility has borne out with the Omicron variant.
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In cases where OSHA determines that a substance is sufficiently harmful that a
grave danger would be created by exposure, OSHA must be allowed to issue
necessary regulations. In other words exposure can be assumed to be occurring at
any place where there is a substance that has been determined to be sufficiently
harmful to pose a grave danger and where the regulations that have been
determined to be necessary to meet that danger are not in effect. This
interpretation of subsection 6(c)(1) is supported by the existence of subsection
6(d), which provides that any affected employer may obtain a variance from any
standard if he can show that “the conditions, practices, means, methods,
operations, or processes used or proposed to be used by an employer will provide
employment and places of employment to his employees which are as safe and
healthful as those which would prevail if he complied with the standard.”
Dry Color Mfrs. Ass’n v. Dep’t of Labor, 486 F.2d 98, 102 n.3 (3d Cir. 1973) (emphasis added).
Thus, OSHA is not required to investigate every business to show that COVID-19 is present in
each workplace nor is it required to prove that every worker will experience the same risk of
harm.3
On this point, OSHA has demonstrated the pervasive danger that COVID-19 poses to
workers—unvaccinated workers in particular—in their workplaces. First, OSHA explains why
the mechanics of COVID-19 transmission make our traditional workplaces ripe for the spread of
the disease, putting workers at heightened risk of contracting it. Transmission can occur “when
people are in close contact with one another in indoor spaces (within approximately six feet for
at least fifteen minutes)” or “in indoor spaces without adequate ventilation where small
respiratory particles are able to remain suspended in the air and accumulate.” 86 Fed. Reg. at
61,409. Transmissibility is possible from those who are symptomatic, asymptomatic, or pre-
symptomatic, and variants are likely to be more transmissible. Id. American workplaces often
require employees to work in close proximity—whether in office cubicles or shoulder-to-
shoulder in a meatpacking plant—and employees generally “share common areas like hallways,
restrooms, lunchrooms[,] and meeting rooms.” Id. at 61,411. Evidence cited by OSHA

3Our dissenting colleague argues that OSHA fails to satisfy the “grave danger” in the workplace limitation
on its authority because it does not establish that “all covered employees have a high risk both of contracting
COVID-19 and suffering severe consequences.” (Dissent Op. at 49) But this section on “Grave Danger” explains
that OSHA is not required to show the presence of COVID-19 in every workplace industry by industry nor that
every employee will be harmed in the same serious way by it. Am. Dental Ass’n, 984 F.2d at 827 (holding that
OSHA is not required to proceed “workplace by workplace”).
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corroborates its conclusion: scientific studies and findings prescribed by the CDC show that the
nature of the disease itself provides significant cause for concern in the workplace. Id. (citing
studies).
OSHA relied on public health data to support its observations that workplaces have a
heightened risk of exposure to the dangers of COVID-19 transmission. Many empirical, peer-
reviewed studies cited by OSHA have found that because of the characteristics of our workplace,
“most employees who work in the presence of other people (e.g., coworkers, customers, visitors)
need to be protected.” 86 Fed. Reg. at 61,412. Reports produced by state public health
organizations corroborate that finding. See, e.g., id. at 61,413 (North Carolina Department of
Health and Human Services reporting that “number of cases associated with workplace clusters
began increasing in several different types of work settings, including meat processing,
manufacturing, retail, restaurants, childcare, schools, and higher education.”); id. (Colorado
Department of Public Health & Environment reporting similar outbreaks across many types of
industries.); id. (Louisiana Department of Health, reporting that “[m]ore than three quarters of
outbreaks through [August 24, 2021] were associated with workplaces.”).4
Having established the risk to covered employees in the workplace, OSHA also set out
evidence of the severity of the harm from COVID-19. Apart from death, COVID-19 can lead to
“serious illness, including long-lasting effects on health,” (now named “long COVID”). Id. at
61,410. It has also “killed over 725,000 people in the United States in less than two years.” Id.
at 61,402. The number of deaths in America has now topped 800,000 and healthcare systems
across the nation have reached the breaking point. COVID-19 affects individuals of all age
groups; but on the whole “working age Americans (18-64 years old) now have a 1 in 14 chance
of hospitalization when infected with COVID-19.” Id. at 61,410. The “severity is also likely
exacerbated by long-standing healthcare inequities experienced by members of many racial and

4Our dissenting colleague argues that OSHA fails to satisfy the grave danger “in the workplace” limitation
on its authority because the Secretary did not specify how many employees would contract the virus at work and
instead “calculated the number of people who happen to work who would, in any event, contract COVID-19.”
(Dissent Op. at 51) As shown in this section, however, OSHA presented substantial evidence both that the
workplaces of virtually every industry across America present a heightened risk of COVID-19 exposure to
employees and that a clear predominance of COVID-19 outbreaks come from workplaces.
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economic demographics.” Id. Compounding matters, mutations of the virus become
increasingly likely with every transmission, contributing to uncertainty and greater potential for
serious health effects. Id. at 61,409. Based on this record, the symptoms of exposure are
therefore neither “easily curable and fleeting” nor is the risk of developing serious disease
speculative. See Fla. Peach Growers, 489 F.2d at 132; Dry Color Mfrs. Ass’n, 489 F.2d at 106.
OSHA further estimated that the standard would “save over 6,500 worker lives and
prevent over 250,000 hospitalizations over the course of the next six months.” Id. at 61,408.
This well exceeds what the Fifth Circuit previously found to present a grave danger. See
Asbestos Info. Ass’n, 727 F.2d at 424 (assuming that 80 deaths over six months would constitute
a grave danger). As the death rate in America has continued to climb throughout 2021, those
estimates may prove to be understated. Bill Chappell, 800,000 Americans Have Died of
COVID. Now
the
U.S.
Braces
for
an
Omicron-Fueled
Spike,
NPR
(Dec.
14,
2021), https://www.npr.org/sections/coronavirus-live-updates/2021/12/14/1063802370/america-
us-covid-death-toll. And where grave danger exists in a workplace, of course OSHA may
consider the statistical proof on lives saved and hospitalizations prevented when issuing an ETS,
even if the risk to individual workers varies within workplaces.
A few Petitioners attack the veracity of some of the studies on which OSHA relies in its
ETS or point to other studies that they claim contradict the studies on which OSHA relied. But
the court’s “expertise does not lie in technical matters.” Pub. Citizen Health Rsch. Grp. v. Tyson,
796 F.2d 1479, 1495 (D.C. Cir. 1986). “[I]t is not infrequent that the available data do not settle
a regulatory issue, and the agency must then exercise its judgment in moving from facts and
probabilities on the record to a policy conclusion.” Id. (quoting Motor Vehicle Mfrs. Ass’n v.
State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 52 (1983)). OSHA pointed to extensive scientific
evidence, including studies conducted by the CDC, of the dangers posed by COVID-19. We
therefore cannot say that OSHA acted improperly in light of its clear reliance on “a body of
reputable scientific thought.” Indus. Union Dep’t., 448 U.S. at 656.
The claim that COVID-19 exists outside the workplace and thus is not a grave danger in
the workplace is equally unavailing. As discussed above, OSHA routinely regulates hazards that
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and Testing, 86 Fed. Reg. 61402
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exist both inside and outside the workplace. More to the point, OSHA here demonstrated with
substantial evidence that the nature of the workplace—commonplace across the country and in
virtually every industry—presents a heightened risk of exposure. Union Petitioners illustrate this
point as well. Within one week in mid-November, Michigan had reported 162 COVID-19
outbreaks, 157 of which were in workplaces;5 Tennessee reported 280 COVID-19 outbreaks,
161 of which were in workplaces;6 Washington state reported 65 outbreaks, of which 58 were in
workplaces.7 And other states similarly experienced outbreaks predominantly in the workplace.8
COVID-19 is clearly a danger that exists in the workplace.
Some Petitioners contend that COVID-19 is no longer a grave danger and claim that
OSHA’s delay in promulgating the ETS is evidence that no grave danger exists. As explained,
however, OSHA provided its reasoning for the delay. When the pandemic began, “scientific
evidence about the disease” and “ways to mitigate it were undeveloped.” 86 Fed. Reg. at 61,429.
At that point, OSHA chose to focus on nonregulatory options, and crafted workplace guidance
“based on the conditions and information available to the agency at that time,” including that
“vaccines were not yet available.” Id. at 61,429–30. The voluntary guidance, however, proved
inadequate, and as employees returned to workplaces the “rapid rise to predominance of the
Delta variant” meant “increases in infectiousness and transmission” and “potentially more severe
health effects.” Id. at 61,409–12.
At the same time, the options available to combat COVID-19 changed significantly: the
FDA granted approval to one vaccine on August 23, 2021, and testing became more readily
available. Id. at 61,431, 61,452. These changes, coupled with the ongoing risk workers face of

5Mich. Dep’t of Health & Human Servs., https://www.michigan.gov/coronavirus/0,9753,7-406-
98163_98173_ 102057---,00.html.
6TN
Dep’t
of
Health,
https://www.tn.gov/content/dam/tn/health/documents/cedep/novel-
coronavirus/Critical IndicatorReport.pdf
7Wash.
Dep’t
of
Health,
https://www.doh.wa.gov/Portals/1/Documents/1600/coronavirus/data-
tables/Statewide COVID-19 OutbreakReport.pdf.
8Union Petitioners point to California, New Mexico, and Oregon as other states that illustrate significant
outbreaks in a variety of workplaces.
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contracting COVID-19, support OSHA’s conclusion that the time was ripe for OSHA to address
the ongoing danger in the workplace through an ETS. More importantly, we are not to second
guess what the Agency considers a “risk worthy of Agency action” because that “is a policy
consideration that belongs, in the first instance to the Agency.” Asbestos Info. Ass’n, 727 F.2d at
425. Relying on the history of the pandemic, OSHA explained that “the agency cannot assume
based on past experience that nationwide case levels will not increase again.” 96 Fed. Reg. at
61,431. That conclusion has proven correct, as we now see the rise of new and more
transmissible variants and the resulting increases in COVID-19 cases. See Centers for Disease
Control and Prevention (CDC), Omicron Variant: What You Need to Know (Dec. 13, 2021),
https://www.cdc.gov/coronavirus/2019-ncov/variants/omicron-variant.html. And we know that
in our nation, over 800,000 people have died in less than two years and the numbers continue to
climb, with more of those deaths having occurred in 2021 than in 2020. See Bill Chappell,
supra.
Based on the wealth of information in the 153-page preamble, it is difficult to imagine
what more OSHA could do or rely on to justify its finding that workers face a grave danger in
the workplace. It is not appropriate to second-guess that agency determination considering the
substantial evidence, including many peer-reviewed scientific studies, on which it relied. Indeed,
OSHA need not demonstrate scientific certainty. As long as it supports it conclusion with
“a body of reputable scientific thought,” OSHA may “use conservative assumptions in
interpreting the data . . . , risking error on the side of overprotection rather than underprotection.”
Indus. Union Dep’t, 448 U.S. at 656.
iii. Necessity
To issue an ETS, OSHA is also required to show that the ETS is “necessary to protect
employees from” the grave danger. 29 U.S.C. § 655(c)(1). This standard is more demanding
than the “reasonably necessary or appropriate” standard applicable to permanent standards. See
id. § 652(8); see also Indus. Union Dep’t, 448 U.S. at 615. To pass muster, OSHA must
demonstrate, by substantial evidence, that the regulation is essential to reducing the grave danger
asserted. See Dry Color, 486 F.2d at 105. In addition, OSHA must address economic feasibility
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because the ETS’s “protection afforded to workers should outweigh the economic consequences
to the regulated industry.” Asbestos Info. Ass’n, 727 F.2d at 423.
Some Petitioners argue the word “necessity” mandates that OSHA’s standard may use
only the means that are absolutely required to quell the grave danger. Taken seriously, such a
cramped reading of the statute would require OSHA to prognosticate an emergency and devise
the most narrowly tailored ETS to entirely remove the grave danger from the workplace. But in
virtually every emergency situation that would require an ETS, no precaution proposed by
OSHA could ever be 100 percent effective at quelling the emergency. Courts have
acknowledged this practical reality, explaining that ETS standards “may necessarily be
somewhat general . . . . It cannot be expected that every procedure or practice will be strictly
necessary as to every substance, type of use, or plant operation.” Dry Color Mfrs. Ass’n, Inc.,
486 F.2d at 105. OSHA need only demonstrate that the solution it proposes “is necessary to
alleviate a grave risk of worker deaths during [the ETS’s] six month term.” Asbestos Info. Ass’n,
727 F.2d at 427 (emphasis added).
The dissent disagrees, contending that the Secretary must rule out alternatives to show
why his proposed means are “indispensable,” pointing us to Asbestos Information Association.
(Dissent Op. at 44) But in that case, the Fifth Circuit found that OSHA’s determination of
necessity for the proposed ETS was undercut by its existing regulation through which “much of
the claimed benefit could be obtained.” 727 F.2d at 427. The Fifth Circuit did not require that
OSHA rule out every plausible alternative in devising its ETS because the critical question was
whether OSHA’s current regulations were sufficient to address the problem. See id. To answer
that question, the Secretary here cataloged OSHA’s actions involving COVID-19, starting with
advisory guidance then moving to attempts to enforce its General Duty clause. 86 Fed. Reg. at
61,444. These actions were to no avail as COVID-19 transmission rates in the workplace
continued to climb and COVID-19-related complaints continued to pour in, suggesting “a lack of
widespread compliance.” Id. at 61,445. With nothing left at his disposal to curb the
transmission in the workplace, the Secretary issued the ETS. We find that this explanation
satisfies the Secretary’s obligation.
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Turning to assess the remaining evidence supporting OSHA’s necessity finding, OSHA
explained that the pandemic in the United States has significantly changed course since the
emergence of COVID-19 in early 2020, necessitating an ETS at this point in time. In particular,
the emergence of the Delta variant significantly increased transmission when reported cases had
been dwindling for months. The realities of the Delta variant significantly changed public health
policy and underscored a need for issuing an ETS—not only to control the variant itself, but to
control the spread of the disease to slow further mutations. 86 Fed. Reg. at 61,431–32.
Recognizing this new reality, the Agency crafted an ETS with options for employers, noting that
“employers in their unique workplace settings may be best situated to understand their workforce
and strategies that will maximize worker protection while minimizing workplace disruptions.”
Id. at 61,436.
Regarding the vaccine component of the ETS, OSHA explained the importance of
vaccination to combat the transmission of COVID-19 and relied upon studies demonstrating the
“power of vaccines to safely protect individuals,” including from the Delta variant. Id. at 61,432,
61,450. Extensive evidence cited by OSHA shows that vaccination “reduce[s] the presence and
severity of COVID-19 cases in the workplace,” and effectively “ensur[es]” that workers are
protected from being infected and infecting others. Id. at 61,434, 61,520, 61,528–29 (citing
studies). Likewise, the face-covering-and-test facet of the ETS is similarly designed based on
the scientific evidence to reduce the risk of transmission and infection of COVID-19. Regular
testing “is essential because SARS-CoV-2 infection is often attributable to asymptomatic or
pre-symptomatic transmission.” Id. at 61,438 (citing studies). And wearing a face covering
provides an additional layer of protection, designed to reduce “exposure to the respiratory
droplets of co-workers and others[, and] . . . to significantly reduce the wearer’s ability to spread
the virus.” Id. at 61,439.
Vaccinated employees are significantly less likely to bring (or if infected, spread) the
virus into the workplace. Id. 61,418–19. And testing in conjunction with wearing a face
covering “will further mitigate the potential for unvaccinated workers to spread the virus at the
workplace.” Id. at 61,439. Based on the evidence relied on by OSHA, these measures will
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“protect workers” from the grave dangers presented by COVID-19 in the workplace. See
29 U.S.C. § 655(c)(1). And OSHA is required to minimize a grave danger, even if it cannot
eliminate it altogether. Nat’l Grain & Feed Ass’n v. Occupational Safety & Health Admin.,
866 F.2d 717, 737 (5th Cir. 1988).
OSHA limited the ETS to coverage of 100 or more employees, based on four reasons.
First, as a practical matter, those employers have the administrative and managerial capacity to
be able to promptly implement and meet the standard. Id. at 61,511. Second, the coverage
threshold is sufficiently expansive to ensure protection to meaningfully curb transmission rates to
offset the impact of the virus. Id. Third, the ETS “will reach the largest facilities, where the
most deadly outbreaks of COVID-19 can occur.” Id. And finally, the standard is consistent with
size thresholds established in analogous congressional and agency decisions, including standards
promulgated by the Equal Employment Opportunity Commission under Title VII of the Civil
Rights Act of 1964, requirements under the Affordable Care Act (in allowing greater flexibility
with its requirements for employers with 100 or fewer employees), and requirements under the
Family Medical Leave Act (exempting compliance for employers with fewer than 50 employees
given decreased administrative capacity and inability to easily accommodate such employee
absences). Id. at 61,513.

Petitioners contend, relying on the Fifth Circuit’s decision, that the necessity of the ETS
is undermined by the fact that it is both “overinclusive” and “underinclusive.” Neither
observation warrants a stay. OSHA may lean “on the side of overprotection rather than
underprotection” when promulgating an ETS. Indus. Union Dep’t, 448 U.S. at 656.9 And
OSHA is not required to proceed “workplace by workplace,” Am. Dental Ass’n, 984 F.2d at 827,
in its ETS nor would it “be expected to conduct on-the-spot investigations,” Dry Color Mfrs.
Ass’n Inc., 486 F.2d at 102 n.3. To expect otherwise of OSHA would belie the whole point of an

9The dissent contends that our citation is inapposite because it “did not review an emergency standard” and
refers to the Secretary’s interpretation of data underlying a risk assessment. (Dissent Op. at 47) The language cited,
however, addresses whether OSHA’s evidence supporting its estimation of a risk, which was the basis for the
standard, was supported by substantial evidence. Indus. Union Dep’t, 448 U.S. at 656. Critically, the substantial
evidence standard at issue there governs both emergency temporary standards and run-of-the-mill OSHA standards
and is applicable here. See 29 U.S.C. § 655(f).
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emergency temporary standard, which demands that OSHA act quickly “to provide immediate
protection” to workers facing a grave danger. Id. at 105. OSHA explored the dangers in varied
workplaces and industries and concluded that “employees can be exposed to the virus in almost
any work setting” and that employees routinely “share common areas like hallways, restrooms,
lunchrooms[,] and meeting rooms” and are at risk of infection from “contact with coworkers,
clients, or members of the public.” 86 Fed. Reg. at 61,411–12. OSHA supported those
conclusions by relying on peer-reviewed studies and data collected by government health
departments. But in any case, OSHA tailored the ETS by excluding workplaces where the risk is
significantly lower, including those where employees are working exclusively outdoors,
remotely from home, or where the employee does not work near any other individuals. Id. at
61,516.

The argument that the ETS is overinclusive because it imposes requirements on some
workers that are at lesser risk of death than others overlooks OSHA’s reasoning. OSHA
promulgated the ETS to prevent employees from transmitting the virus to other employees—that
risk is not age-dependent. See, e.g., id. at 61,403; 61,418–19; 61,435; 61,438. OSHA found that
unvaccinated workers in workplaces where they encountered other workers or customers faced a
grave danger and that vaccination or testing and masking were necessary to protect those
workers from COVID-19. Those workers are in “a wide variety of work settings across all
industries” thus counseling for the broad standard. Id. at 61,411–12.

That the ETS is underinclusive, as some Petitioners argue, suggests that OSHA has not
done enough to eliminate the grave danger facing workers, and more workplace safeguards—not
fewer—are needed to protect the workplace. And OSHA explained that it chose a tailored
threshold because those employers would be best positioned to actually effectuate the standard
and their employees are more at risk. Id. at 61,513 (“OSHA has set the threshold for coverage
based primarily on administrative capacity for purposes of protecting workers as quickly as
possible.”); id. at 61,512 (suggesting that “larger employers are more likely to have many
employees gathered in the same location” and have “larger” and “longer” outbreaks).
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OSHA also demonstrates that selecting larger employers means that the ETS reaches enough
workers to make a meaningful difference in mitigating the risk. Id. at 61,513.

It has long been the case that an agency “is not required to identify the optimal threshold
with pinpoint precision. It is only required to identify the standard and explain its relationship to
the underlying regulatory concerns.” Nat’l Shooting Sports Found. v. Jones, 716 F.3d 200, 214
(D.C. Cir. 2013) (quoting WorldCom, Inc. v. FCC, 238 F.3d 449, 461–62 (D.C. Cir. 2001)); see
also Providence Yakima Med. Ctr. v. Sebelius, 611 F.3d 1181, 1191 (9th Cir. 2010); Williams-
Yulee v. Fla. Bar, 575 U.S. 433, 449 (2015) (noting that the government “need not address all
aspects of a problem in one fell swoop”). Courts are “generally unwilling to review line-drawing
performed by the [agency] unless a petitioner can demonstrate that lines drawn . . . are patently
unreasonable, having no relationship to the underlying regulatory problem.” Cassel v. FCC,
154 F.3d 478, 485 (D.C. Cir. 1998) (alteration in original) (quoting Home Box Off., Inc. v. FCC,
567 F.2d 9, 60 (D.C. Cir. 1977)). OSHA’s ETS readily shows a relationship to the underlying
regulatory problem—larger employers are better able to implement the policies, are at
heightened risk, and regulating them will be a significant step in protecting the entire workforce
from COVID-19 transmission. And of course, agencies can later revise, refine, and broaden (or
narrow) their regulations, but exigent circumstances allow there to be some reasonable discretion
at the initial steps of promulgating a regulation. See Forging Indus. Ass’n, 773 F.2d at 1454;
United Steelworkers of Am., 647 F.2d at 1309–10 (D.C. Cir. 1980).

Turning to the cost analysis, OSHA is not required to conduct a “formal cost-benefit
analysis” before issuing an ETS. Asbestos Info. Ass’n, 727 F.2d at 423 n.18 (reasoning that it is
“unlikely” that “the agency would have time to conduct such an analysis” in the context of an
emergency). Congress recognized that OSHA standards would impose costs, but placed “the
benefit of worker health above all other considerations save those making attainment of this
benefit unachievable.” Am. Textile Mfrs. Inst., 452 U.S. at 509. The question is whether the
standard is economically feasible. United Steelworkers of Am., 647 F.2d at 1264. An OSHA
“standard is economically feasible if the costs it imposes do not ‘threaten massive dislocation
to, or imperil the existence of, the industry.’” Am. Iron & Steel Inst. v. Occupational Safety
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& Health Admin., 939 F.2d 975, 980 (D.C. Cir. 1991) (quoting United Steelworkers of Am.,
647 F.2d at 1265). OSHA must consider the costs in relation to the financial health of the
affected industries or their impact on consumer prices. United Steelworkers of Am., 647 F.2d at
1265.
Here, OSHA conducted a detailed economic analysis, concluding that the costs amounted
to approximately 0.02 percent of the revenue of the average covered employer, or about $11,298
per affected entity. 86 Fed. Reg. at 61,493–94. “To put this into perspective, if the average firm
decided to raise prices to cover the costs of the ETS, the price of a $100 product or service, for
example, would have to be increased by 2 cents (during the six-month period).” Id. at 61,499.
These costs are modest in comparison to other standards OSHA has implemented. See, e.g.,
United Steelworkers of Am., 647 F.2d at 1281 (estimating capital costs for primary lead smelters
to comply with OSHA’s lead exposure standard to be between $32 million and $47 million).
OSHA’s analysis, moreover, does not consider the economic harm a business will undergo if it is
closed by a COVID-19 outbreak in its workplace—taking this into account would further show
that the benefits will outweigh the costs of the ETS. If the costs of implementation become too
high for a single business, an employer can raise infeasibility or impossibility as a defense to any
citation that OSHA may issue for violating the ETS. 29 C.F.R. § 2200.34(b)(3).

Based on the substantial evidence referenced and relied upon by OSHA, there is little
likelihood of success for the challenges against OSHA’s bases for issuing the ETS.
4. Constitutional Challenges
We turn to the likelihood of success on the remaining constitutional arguments raised by
the Petitioners and were presumed persuasive by the Fifth Circuit.10

10Some Petitioners raise challenges regarding religious liberty. The ETS states, “if the vaccination, and/or
testing for COVID-19, and/or wearing a face covering conflicts with a sincerely held religious belief, practice or
observance, a worker may be entitled to a reasonable accommodation.” 86 Fed. Reg. at 61,522. Therefore,
Petitioners are unlikely to succeed on their argument that the ETS infringes on religious liberty. Regardless, their
circumstance-specific arguments are premature and do not provide a basis to stay the entire ETS.
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i. Commerce Clause
First, Petitioners raise challenges to the ETS under the Commerce Clause, directing us to
the Fifth Circuit’s conclusion that the ETS “likely exceeds the federal government’s authority
under the Commerce Clause because it regulates noneconomic inactivity that falls squarely
within the States’ police power.” BST Holdings, 17 F.4th at 617. Relying on National
Federation of Independent Business v. Sebelius, 567 U.S. 519, 522 (2012), the Fifth Circuit
reasoned that “[a] person’s choice to remain unvaccinated and forego regular testing is
noneconomic activity,” and falls within the States’ police power. Id. On that basis, the stay
opinion summarily concluded that because the ETS “commandeers” employers to compel
activity that falls within the States’ police power, it “far exceed[s] current constitutional
authority.” Id.

Petitioners and the Fifth Circuit miss the mark. The ETS regulates employers with more
than 100 employees, not individuals. It is indisputable that those employers are engaged in
commercial activity that Congress has the power to regulate when hiring employees, producing,
selling and buying goods, etc. See NFIB, 567 U.S. at 550 (“The power to regulate commerce
presupposes the existence of commercial activity to be regulated.”). The ETS regulates
economic activity by regulating employers.
It has long been understood that regulating employers is within Congress’s reach under
the Commerce Clause. To hold otherwise would upend nearly a century of precedent upholding
laws that regulate employers to effectuate a myriad of employee workplace policies. See, e.g.,
United States v. Darby, 312 U.S. 100, 109, 114 (1941) (finding the Fair Labor Standards Act
imposed a permissible use of government power when it set a minimum wage standard to
prevent the production of goods “for interstate commerce, under conditions detrimental to the
maintenance of the minimum standards of living necessary for health and general well-being”);
United Steelworkers of Am., AFL-CIO v. Weber, 443 U.S. 193, 206 n.6 (1979) (finding proper
use of the commerce power to bar employers from discriminating against employees on a
protected ground under Title VII); NLRB v. Jones & Laughlin Steel Corp., 301 U.S. 1, 33 (1937)
(finding proper use of commerce power to safeguard “the right of employees to self-organization
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and to select representatives of their own choosing for collective bargaining or other mutual
protection without restraint or coercion by their employer”). These cases recognize, for example,
that, a person’s choice to discriminate against another based on race is “noneconomic activity,”
but the effect of that choice on the workplace and the flow of commerce in and from that
workplace is economic—hence, it is subject to regulation under the Commerce Clause.
Cf. Heart of Atlanta Motel, Inc. v. United States, 379 U.S. 241, 253 (1964) (finding
“discrimination by hotels and motels impedes interstate travel”).

That principle was at the heart of the Supreme Court’s decision in NLRB v. Jones &
Laughlin Steel, 201 U.S. 1 (1927). There, the Court emphasized that to determine the Commerce
Clause’s applicability, we focus on the “effect upon commerce, not the source of the injury,” 301
U.S. at 32, and that Congress may legislate under the Commerce Clause to ensure the safety of
commerce, id. at 37. When industries occupy a “national scale,” moreover, Congress may
protect interstate commerce from “paraly[sis].” Id. at 41. COVID-19’s paralyzing effect on
commerce has been repeatedly demonstrated throughout the pandemic. See, e.g., U.S. Bureau of
Labor
Statistics,
TED:
The
Economics
Daily
(July
8,
2021),
https://www.bls.gov/opub/ted/2021/6-2-million-unable-to-work-because-employer-closed-or-
lost-business-due-to-the-pandemic-june-20 21.htm.

This also demonstrates why NFIB v. Sebelius is inapposite. In NFIB, the Supreme Court
considered challenges to the Affordable Care Act’s individual mandate. 567 U.S. at 539.
Critically, and fatal to the Fifth Circuit’s point, the Affordable Care Act contains two separate
types of mandates: the individual mandate to direct individuals to purchase health insurance—at
issue in NFIB—and the employer mandate—not at issue in NFIB. See 26 U.S.C. § 4980H. A
plurality of five Justices questioned whether the Commerce Clause gave Congress the power to
mandate that people engage in economic activity to sustain the individual mandate. See NFIB,
567 U.S. at 547–58. But no Justice doubted that Congress could, under the Commerce Clause,
require employers to provide health insurance to their employees. So too here.

Citing Zucht v. King, 260 U.S. 174 (1922), and Jacobson v. Massachusetts, 197 U.S. 11
(1905), Petitioners and the Fifth Circuit contend that the ETS “falls squarely within the States’
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police powers.” BST Holdings, 17 F.4th at 617. But those cases concerned challenges to state
vaccine requirements under the Fourteenth Amendment, not federalism questions over whether
states or the federal government can impose such a requirement. If the suggestion here is that the
federal and state regulatory powers over economic activity are mutually exclusive, the Supreme
Court rejected that argument in Willson v. Black Bird Creek Marsh Co., 27 U.S. 245, 251–52
(1829) (holding an act empowering the State’s construction of a dam that obstructed an interstate
walkway is not “repugnant to the power to regulate commerce in its dormant state”). To be sure,
there are numerous areas—for example, education—in which States and the federal government
have overlapping authority. But that states may regulate COVID-19 safety measures does not
operate to preclude the federal government from doing so.

Finally, Congress already addressed the issue when it passed the OSH Act, expressing its
intention to preempt state and local standards that conflict with OSHA standards. See Gade,
505 U.S. at 98–99 (holding that “nonapproved state regulation of occupational safety and health
issues for which a federal standard is in effect is impliedly preempted” by OSHA’s standard).
Hazards are often regulated by both OSHA and state agencies, such as exposure to lead. But
overlap does not limit the authority Congress granted to OSHA to regulate the same risk of
exposure.

For the foregoing reasons, the Commerce Clause challenges do not have a meaningful
likelihood of success.
ii. Non-Delegation Doctrine

Relying on the Fifth Circuit’s decision, Petitioners cast constitutional doubt on the ETS
by questioning Congress’s delegation of authority to OSHA when it passed the OSH Act. The
Fifth Circuit cursorily concluded that Congress cannot “authorize a workplace safety
administration in the deep recesses of the federal bureaucracy to make sweeping pronouncement
on matters of public health affecting every member of society in the profoundest of ways.” BST
Holdings, 17 F.4th at 611. That contention never specifies which provision of the OSH Act is an
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improper delegation. We therefore construe its analysis in line with the Petitioners’ arguments
that 29 U.S.C. § 655(c)(1) constitutes an improper delegation.

The Supreme Court has only twice invoked the non-delegation doctrine to strike down a
statute. See Panama Refin. Co. v. Ryan, 293 U.S. 388, 430 (1935); A.L.A. Schechter Poultry
Corp. v. United States, 295 U.S. 495, 542 (1935). In Gundy v. United States, the Supreme Court
stated that, “[t]he nondelegation doctrine bars Congress from transferring its legislative power to
another branch of Government.” 139 S.Ct. 2116, 2121 (2019) (plurality opinion). “But the
Constitution ‘does not deny[] to the Congress the necessary resources of flexibility and
practicality [that enable it] to perform its function[s].” Id. at 2123 (alterations in original)
(quoting Yakus v. United States, 321 U.S. 414, 425 (1944)) (alterations in original). To the
contrary, Congress “may confer substantial discretion on executive agencies to implement and
enforce the laws.” Id. (citing Mistretta v. United States, 488 U.S. 361, 372 (1989)). A statutory
delegation is therefore constitutional as long as “Congress ‘lay[s] down by legislative act an
intelligible principle to which the person or body authorized to [exercise the delegated authority]
is directed to conform.’” Id. (quoting Mistretta, 488 U.S. at 372) (alterations in original). The
starting and often ending point for the analysis is “statutory interpretation”: We must “constru[e]
the challenged statute to figure out what task it delegates and what instructions it provides” and
then “decide whether the law sufficiently guides executive discretion to accord with Article I.”
Id. at 2124.

The Supreme Court has long recognized the power of Congress to delegate broad swaths
of authority to executive agencies under this standard and has ultimately concluded that
extremely broad standards will pass review. See id. at 2129. How broad? Delegations to
regulate in the “public interest,” Nat’l Broad. Co. v. United States, 319 U.S. 190, 216 (1943), to
set “fair and equitable prices,” Yakus, 321 U.S. at 427, and to issue air quality standards
“requisite to protect the public health,” Whitman v. Am. Trucking Ass’n, 531 U.S. 457, 472
(2001). See Gundy, 139 S. Ct. at 2129 (collecting sources).

Our extensive discussion of the statutory framework of the OSH Act above starts and
ends the inquiry. OSHA’s statutory authority to issue standards is found in 29 U.S.C. § 655.
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Specific authorization is in § 655(c)(1) and requires the Secretary to promulgate “emergency
temporary standards,” when he determines that employees are in “grave danger” from exposure
to a workplace hazard and that the standard is “necessary to protect the employees from such
danger.” As shown above, it is well-established that the scope of the OSH Act and OSHA’s
authority include infectious diseases in the workplace, even when those diseases also exist
outside the workplace. Therefore, Congress applied an “intelligible principle” when it directly
authorized OSHA to exercise this delegated authority in particular circumstances. The Supreme
Court long ago recognized this authority: “The [Occupational Safety and Health] Act delegates
broad authority to the Secretary to promulgate different kinds of standards.” Indus. Union Dep’t,
448 U.S. at 611.
There is little possibility of success under the non-delegation doctrine.
C. Irreparable Harm
The foregoing analysis shows that Petitioners cannot establish a likelihood of success on
the merits, and this reason alone is sufficient to dissolve the stay. Nken, 556 U.S. at 433–34. We
also conclude, however, that Petitioners have not shown that any injury from lifting the stay
outweighs the injuries to the Government and the public interest.
To merit a stay, Petitioners bear the burden to demonstrate an irreparable injury; “simply
showing some ‘possibility of irreparable injury’ fails to satisfy the second factor.” Nken,
556 U.S. at 434–35 (quoting Abbassi v. INS, 143 F.3d 513, 514 (9th Cir. 1998)). Moreover,
because this case involves the Government as an opposing party, the third and fourth factors
“merge.” Id. at 435. The Fifth Circuit failed to analyze any harm to OSHA, instead baldly
concluding that a stay will “do OSHA no harm whatsoever.” BST Holdings, 17 F.4th at 618.
We engage in our own balancing of the parties’ harm.

The injuries Petitioners assert are entirely speculative. First, some Petitioners assert that
compliance costs will be too high. As detailed in the preceding section, these assertions ignore
the economic analysis OSHA conducted that demonstrates the feasibility of implementing the
ETS. To the extent that a business with over 100 employees impacted at this stage of the ETS
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faces true impossibility of implementation, it can assert that as an affirmative defense in response
to a citation. 29 C.F.R. § 2200.34(b)(3). Relying on employee declarations, other Petitioners
claim that they will need to fire employees, suspend employees, or face employees who quit over
the standard. These concerns fail to address the accommodations, variances, or the option to
mask-and-test that the ETS offers. For example, employers that are confident that they can keep
their employees safe using alternative measures can seek a variance from the standard pursuant
to 29 U.S.C. § 655(d). Or employers may choose to comply with the standard by enforcing the
mask-and-test component, which are entirely temporary in nature and do not create irreparable
injuries. These provisions of the ETS undercut any claim of irreparable injury.

By contrast, the costs of delaying implementation of the ETS are comparatively high.
Fundamentally, the ETS is an important step in curtailing the transmission of a deadly virus that
has killed over 800,000 people in the United States, brought our healthcare system to its knees,
forced businesses to shut down for months on end, and cost hundreds of thousands of workers
their jobs. In a conservative estimate, OSHA finds that the ETS will “save over 6,500 worker
lives and prevent over 250,000 hospitalizations” in just six months. 86 Fed. Reg. 61,402,
61,408. A stay would risk compromising these numbers, indisputably a significant injury to the
public. The harm to the Government and the public interest outweighs any irreparable injury to
the individual Petitioners who may be subject to a vaccination policy, particularly here where
Petitioners have not shown a likelihood of success on the merits. See Coleman v. Paccar, Inc.,
424 U.S. 1301, 1307–08 (1976).

In light of the foregoing, we find that the factors regarding irreparable injury weigh in
favor of the Government and the public interest.
III. CONCLUSION
For the foregoing reasons, we GRANT the Government’s motion and DISSOLVE the
stay issued by the Fifth Circuit.

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_________________
CONCURRENCE
_________________
GIBBONS, Circuit Judge, concurring. I agree that the government’s motion to dissolve
the stay should be granted and concur fully in Judge Stranch’s opinion. I write separately to note
the limited role of the judiciary in this dispute about pandemic policy. Petitioners and various
opinions discuss at length how OSHA could have handled the pandemic’s impact on places of
employment differently. Some of the writings include sweeping pronouncements about
constitutional law and the scope of OSHA’s statutory authority. Much of this writing is
untethered from the specific facts and issues presented here and overlooks the limited nature of
our role.
Reasonable minds may disagree on OSHA’s approach to the pandemic, but we do not
substitute our judgment for that of OSHA, which has been tasked by Congress with policy-
making responsibilities. See Charles D. Bonnano Linen Serv., Inc. v. NLRB, 454 U.S. 404, 418
(1982). This limitation is constitutionally mandated, separating our branch from our political co-
branches. “[F]ederal judges—who have no constituency—have a duty to respect legitimate
policy choices made by those who do.” Chevron, U.S.A., Inc. v. NRDC, Inc., 467 U.S. 837, 866
(1984). Beyond constitutional limitations, the work of an agency, often scientific and technical
in nature, is outside our expertise. See Kisor v. Wilkie, 139 S. Ct. 2400, 2413 (2019).
Our only responsibility is to determine whether OSHA has likely acted within the bounds
of its statutory authority and the Constitution. As it likely has done so, I concur.

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_________________
DISSENT
_________________
LARSEN, Circuit Judge, dissenting. As the Supreme Court has very recently reminded
us, “our system does not permit agencies to act unlawfully even in pursuit of desirable ends.”
Ala. Ass’n of Realtors v. Dep’t of Health & Hum. Servs., 141 S. Ct. 2485, 2490 (2021). The
majority’s theme is that questions of health science and policy lie beyond the judicial ken.
I agree. But this case asks a legal question: whether Congress authorized the action the agency
took. That question is the bread and butter of federal courts. And this case can be resolved using
ordinary tools of statutory interpretation and bedrock principles of administrative law. These tell
us that petitioners are likely to succeed on the merits, so I would stay OSHA’s emergency rule
pending final review.
I.
The majority opinion describes the emergency rule at issue here as permitting employers
“to determine for themselves how best to minimize the risk of contracting COVID-19 in their
workplaces.” Maj. Op. at 7. With respect, that was the state of federal law before the rule, not
after.
Here is what the emergency rule does. It binds nearly all employers with 100 or more
employees,1 and requires them to “establish, implement, and enforce a written mandatory
vaccination policy.” 29 C.F.R. § 1910.501(b)(1), (d)(1). It covers all employees, part-time, full-
time, and seasonal, except for those who work exclusively from home, outdoors, or alone. Id.

1The rule exempts employers covered by two different federal rules: the federal contractors and
subcontractors already subject to a vaccine mandate and healthcare workers subject to OSHA’s June 2021
emergency standard. 29 C.F.R. § 1910.501(b)(2). The latter rule required healthcare employers to adopt a COVID-
19 protection plan and encouraged vaccination but did not impose a vaccinate-or-test mandate. Id. § 1910.502. In
addition, neither “the United States . . . [n]or any State or political subdivision of a State” is a covered “employer.”
29 U.S.C. § 652(5). Several states say that they nonetheless will be forced to comply with the standard because they
have adopted their own OSHA plans pursuant to 29 U.S.C. § 667. Such plans must be “at least as effective in
providing safe and healthful employment and places of employment as the standards promulgated under section
655.” Id. § 667(c)(2).
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§ 1910.501(b)(3). Employees must “be fully vaccinated,” unless they qualify for medical or
religious exemptions or reasonable accommodations. Id. § 1910.501(c). While vaccines are free
to the public, employers must provide employees with paid time off both to secure the vaccine
and to recover from any side effects. Id. § 1910.501(f).
An employer may instead permit unvaccinated employees to undergo weekly COVID-19
testing and wear a mask in the workplace. Id. § 1910.501(d)(2), (g)(1), (i)(1). But OSHA
consciously designed this exception to be less palatable to employers and employees. The
agency expects that employers who adopt a mandatory-vaccination policy will “enjoy
advantages,” including fewer “administrative burden[s],” than employers who permit the mask-
and-test exception. 86 Fed. Reg. at 61,437. And even if an employer elects to take on these
additional burdens, it need not absorb the cost of masks and tests, nor provide time off (paid or
otherwise) to secure them. Id. § 1910.501(d)(2), (g)(1) n.1. This, despite the fact that OSHA’s
ordinary regulations require employers to pay for agency-mandated equipment, tests, and exams.
See Employer Payment for Personal Protective Equipment, 72 Fed. Reg. 64,341, 64,342 (Nov.
15, 2007); 86 Fed. Reg. at 61,532 (noting OSHA “has commonly required” employers to pay for
protective equipment); 29 C.F.R. § 1910.1030(d)(3)(i), (f)(1)(ii) (Hepatitis B equipment and
testing “at no cost”); id. § 1910.1018(j)(1), (n)(1)(ii) (same for arsenic); id. § 1910.1001(h)(1),
(l)(1)(ii)(A) (same for asbestos); Sec’y of Lab. v. Beverly Healthcare-Hillview, 541 F.3d 193,
200–01 (3d Cir. 2008) (OSHA’s interpretation of “at no cost” includes compensation for testing
time and travel expenses). Indeed, OSHA required employers to provide COVID-19 tests “at no
cost” to employees under its earlier healthcare ETS. See 29 C.F.R. § 1910.502(l)(1)(ii). OSHA
was candid about why it deviated from its normal rule: Putting the onus on employees “will
provide a financial incentive . . . to be fully vaccinated.” 86 Fed. Reg. at 61,437. The rule, in
sum, is a mandate to vaccinate or test.
One more background point: The purpose of the mandate is to protect unvaccinated
people. Id. at 61,419. The rule’s premise is that vaccines work. Id. And so, OSHA has
explained that the rule is not about protecting the vaccinated; they do not face “grave danger”
from working with those who are not vaccinated. Id. at 61,434.
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The various monitoring and reporting duties required by the mandate were to go into
effect on December 6, 2021. 29 C.F.R. § 1910.501(m)(2)(i). And employees were required to
be fully vaccinated or comply with mask-and-test requirements (if available) by January 4, 2022.
Id. § 1910.501(m)(2)(ii). The United States Court of Appeals for the Fifth Circuit stayed the
enforcement of the vaccinate-or-test mandate. BST Holdings, LLC v. Occupational Safety
& Health Admin., 17 F.4th 604 (5th Cir. 2021). After a multi-circuit lottery held pursuant to
28 U.S.C. § 2112(a)(3), this court obtained jurisdiction over all petitions challenging the mandate
filed throughout the country. OSHA has now moved to dissolve the stay entered by the Fifth
Circuit.2
II.
A. Likelihood of Success on the Merits
In this case, a multitude of petitioners—individuals, businesses, labor unions, and state
governments—have levied serious, and varied, charges against the mandate’s legality. They say,
for example, that the mandate violates the nondelegation doctrine, the Commerce Clause, and
substantive due process; some say that it violates their constitutionally protected religious
liberties and the Religious Freedom Restoration Act of 1993. To lift the stay entirely, we would
have to conclude that not one of these challenges is likely to succeed. A tall task. To keep the
stay, however, there is no need to resolve each of these questions; the stay should remain if we
conclude that petitioners are likely to succeed on just one ground. In my view, the petitioners
have cleared this much lower bar on even the narrowest ground presented here: The Secretary of
Labor lacks statutory authority to issue the mandate. So the most important factor supporting the
stay is satisfied. See Tiger Lily, LLC v. U.S. Dep’t of Hous. & Urb. Dev., 992 F.3d 518, 524 (6th
Cir. 2021).

2Petitioners moved for initial en banc hearing, which this court denied. In re MCP No. 165, No. 21-7000,
2021 WL 5914024, at *1 (6th Cir. Dec. 15, 2021). I would have granted the petitions regardless of the merits of the
case. Given the unique nature of these consolidated proceedings, I thought it preferable to enlist the talents of all
sixteen active judges. This panel agreed that the work of the en banc court was separate from the work of this panel
and that the orders and opinions from each should issue as soon as they were ready.
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1. Statutory Authority
OSHA cannot act without a source of authority. The ordinary way to bring about a rule
affecting the people’s health and safety is for a state legislature, or sometimes Congress, to pass
one into law. Because the legislature “wields the formidable power of ‘prescrib[ing] the rules by
which the duties and rights of every citizen are to be regulated,’” it is, by design, the branch of
government “most responsive to the will of the people.” Tiger Lily, LLC v. U.S. Dep’t of
Housing & Urb. Dev., 5 F.4th 666, 674 (6th Cir. 2021) (Thapar, J., concurring) (quoting The
Federalist No. 78, at 465 (Alexander Hamilton) (Clinton Rossiter ed., 1961)).
But there is a workaround. “In the modern administrative state, many ‘laws’ emanate not
from Congress but from administrative agencies, inasmuch as Congress has seen fit to vest broad
rulemaking power in the executive branch.” Cmty. Nutrition Inst. v. Young, 818 F.2d 943, 951
(D.C. Cir. 1987) (Starr, J., concurring in part and dissenting in part). To preserve at least a
modicum of democratic protections, Congress created the notice-and-comment requirements of
the Administrative Procedure Act (APA), which provide public notice of a proposed rule and an
opportunity for the public to express its concerns. Id. Whether successful or not, the aim is to
ensure “that agency ‘rules’ are also carefully crafted (with democratic values served by public
participation) and developed only after assessment of relevant considerations.” Id.
Consistent with this scheme, Congress delegated to OSHA the authority to promulgate
“occupational safety or health standard[s]” that are “reasonably necessary or appropriate” to
address a “significant risk” of harm in the workplace. See Indus. Union Dep’t, AFL-CIO v. Am.
Petroleum Inst., 448 U.S. 607, 642–43 (1980); 29 U.S.C. §§ 652(8), 655(b). Those standards
must go through a notice-and-comment procedure. 29 U.S.C. § 655(b) (prescribing procedures
similar to those of the APA).
This case, though, involves yet a more truncated process. Congress understood that
emergencies might arise, and so it provided the Secretary with authority to bypass the public and
the deliberative process, and to issue emergency temporary standards that “take immediate effect
upon publication” and remain effective for six months. Id. § 655(c)(1), (c)(3). Because this is
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such a departure from the ordinary processes, federal courts have recognized this authority as the
“most dramatic weapon in [OSHA’s] enforcement arsenal.” Asbestos Info. Ass’n/N. Am. v.
Occupational Safety & Health Admin., 727 F.2d 415, 426 (5th Cir. 1984). It is an
“[e]xtraordinary power” that “should be delicately exercised, and only in those emergency
situations which require it.” Fla. Peach Growers Ass’n, Inc. v. Dep’t of Lab., 489 F.2d 120,
129–30 (5th Cir. 1974); see also Pub. Citizen Health Rsch. Grp. v. Auchter, 702 F.2d 1150, 1155
(D.C. Cir. 1983) (“[E]mergency standards are to be used only in limited situations” and “only as
an unusual response to exceptional circumstances.” (quotation marks omitted)).
Perhaps wary of misusing such immense authority, OSHA has rarely invoked it. The
agency has issued only ten previous emergency standards in the half-century that it has held that
power. Six of those were challenged in court; five were struck down. BST Holdings, 17 F.4th at
609.
Congress too was wary of conferring this authority, “repeatedly express[ing] its concern
about allowing the Secretary to have too much power” in this area. Indus. Union, 448 U.S. at
651. Accordingly, Congress “narrowly circumscribed” the Secretary’s ability to use this
considerable tool. Id. Before the Secretary may issue an emergency standard, he must
“determine[] (A) that employees are exposed to grave danger from exposure to substances or
agents determined to be toxic or physically harmful or from new hazards, and (B) that such
emergency standard is necessary to protect employees from such danger.”3 29 U.S.C § 655(c)(1)
(emphases added).
So the Secretary’s emergency authority extends no further than to issue temporary
standards that are (1) necessary to protect employees from (2) grave danger. And because the
Secretary’s authority is to set “occupational safety and health standards,” governing
“employment and places of employment,” the danger to be regulated must come from

3I assume here that the virus that causes COVID-19 constitutes a “substance[] or agent[] determined to be
toxic or physically harmful” or a “new hazard,” within the meaning of § 655(c)(1). Even if so, OSHA lacked
authority to issue the rule.
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(3) “exposure” in the workplace. 29 U.S.C. §§ 652(8), 655(c)(1); Indus. Union, 448 U.S. at 612.
I doubt the Secretary has met this test.
a. Necessary
The Secretary has not made the appropriate finding of necessity. An emergency standard
must be “necessary to protect employees from [grave] danger.” 29 U.S.C. § 655(c)(1).
“Necessary,” in the legal vernacular, is a tailoring word. It asks how closely, or how loosely, a
regulatory solution must fit a particular problem. Sometimes “necessary” means simply
“useful.” Necessary, Black’s Law Dictionary (5th ed. 1979). In those instances, the government
may impose solutions that it thinks might help the problem, even if it ends up regulating a good
deal more than it really needs to. At other times, though, “necessary” means “indispensable.”
American Heritage Dictionary of the English Language 877 (1976). Then, the government must
stitch together its solution with more precision, regulating only as much as is critical to its
mission. Every American law student will be familiar with these dueling meanings of
“necessary,” prominently displayed in McCulloch v. Maryland, 17 U.S. (4 Wheat.) 316 (1819).
There, as here, the choice between meanings is revealed by context.
Consider first the textual differences between a permanent OSHA standard and an
emergency one. A permanent standard, issued after public notice and comment, need be only
“reasonably necessary or appropriate” to address the problem at hand. 29 U.S.C. § 652(8); see
Indus. Union, 448 U.S. at 642–43. But when conferring emergency authority on the Secretary,
Congress shaved that down to “necessary.” An emergency measure must, therefore, be more
than “reasonably” needful; it must be closer to “indispensable.” Cf. McCulloch, 17 U.S. (4
Wheat.) at 413–15. And then consider context. The Supreme Court has already said that
Congress “narrowly circumscribed” the Secretary’s authority to issue emergency standards.
Indus. Union, 448 U.S. at 651 & n.59. It follows that, in this context especially, “necessary”
must be read as a word of limitation, not enlargement. Cf. McCulloch, 17 U.S. (4 Wheat.) at
420.
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The majority opinion initially agrees with this statutory construction point. It notes that
an emergency standard must be more than “reasonably necessary”; it must be “essential.” Maj.
Op. at 25. But then that word, and the concept, disappear from the analysis. What starts as a
demand for an “essential” solution, quickly turns into acceptance of any “effective” or
“meaningful[]” remedy, id. at 26–30; and later, acquiescence to a solution with a mere
“reasonable” “relationship” to the problem, id. at 30. The majority opinion never explains why
“necessary” undergoes such a metamorphosis.
While the majority opinion starts with the right read on the statute, the Secretary seems to
have missed this point altogether. He made no finding that the emergency rule is “necessary” in
any sense even approaching “indispensable.” We cannot uphold a rule based on a finding the
agency never made. S.E.C. v. Chenery Corp., 318 U.S. 80, 87 (1943).
What the Secretary did say is that the agency’s existing regulatory tools and “non-
mandatory guidance” were insufficient. 86 Fed. Reg. at 61,440, 61,444. In other words, OSHA
believed there was a problem to be solved. But the statute requires OSHA to find that the
solution it actually picked—the nationwide vaccinate-or-test mandate—was “necessary” to solve
the problem.4 See 29 U.S.C § 655(c)(1); see also Asbestos Info., 727 F.2d at 426–27 (OSHA
failed to show that an emergency standard was “necessary” when other means were available “to
achieve the projected benefits.”). OSHA never makes that case. Like the majority opinion, the
Secretary focused on explaining why his solution will be effective. 86 Fed. Reg. at 61,434–39.
But that is not enough. Many over-broad solutions might work; but they would not be a
“necessary,” or “indispensable,” means of curing the ill.

4The statute requires the Secretary to find that “such” emergency standard is necessary. 29 U.S.C.
§ 655(c)(1). In other words, he must find that this solution—the vaccinate-or-test mandate—is indispensable. The
majority opinion suggests that the Secretary’s duty would be fulfilled if he found simply that “an” emergency
standard (whatever its content) is necessary. Maj. Op. at 6; id. at 26 (citing Asbestos Info., 727 F.2d at 427). That
reading is inconsistent with the statutory text.
To the extent that the majority reads my opinion to say that an emergency standard must remove the grave
danger from the workplace entirely, that is a misread. I do not read “necessary” to require total elimination of the
harm.
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To illustrate (without intending to trivialize) OSHA’s task, consider the danger from fire
in a workplace: a pizzeria. One way to protect the workers would be to require all employees to
wear oven mitts all the time—when taking phone orders, making deliveries, or pulling a pizza
from the flames. That would be effective—no one would be burned—but no one could think
such an approach necessary. What OSHA’s rule says is that vaccines or tests for nearly the
whole American workforce will solve the problem; it does not explain why that solution is
necessary.
Bedrock principles of administrative law also support this point. It is a “quintessential
aspect[] of reasoned decisionmaking” that an agency explore “common and known or otherwise
reasonable options” and “explain any decision to reject” them. Int’l Ladies’ Garment Workers’
Union v. Donovan, 722 F.2d 795, 818 (D.C. Cir. 1983); see also Dist. Hosp. Partners, LP v.
Burwell, 786 F.3d 46, 58–59 (D.C. Cir. 2015) (holding an agency action arbitrary and capricious
for failing to explain inconsistencies in the agency’s own data when the data revealed a
“significant and viable and obvious” alternative that the agency failed to consider (quoting Nat’l
Shooting Sports Found., Inc. v. Jones, 716 F.3d 200, 215, 405 (D.C. Cir. 2013)). Emergency
decisionmaking may lessen, but does not relieve, the agency of this basic responsibility. While a
temporary measure may require “further refinement in the subsequent permanent standard,” the
agency should “not overlook those obvious distinctions . . . that make certain regulations that are
appropriate in one category of cases entirely unnecessary in another.” Dry Color Mfrs.’ Ass’n v.
Dep’t of Lab., 486 F.2d 98, 105 (3d Cir. 1973); see also id. at 107 (Emergency standard must
explain “the alternative kinds of regulations considered by OSHA.”).
OSHA’s mandate applies, in undifferentiated fashion, to a vast swath of Americans: 84
million workers, 26 million unvaccinated, with varying levels of exposure and risk. 86 Fed. Reg.
at 61,424. The burden is on “the agency to articulate rationally why the rule should apply to a
large and diverse class.” United States v. Nova Scotia Food Prods. Corp., 568 F.2d 240, 252 (2d
Cir. 1977). The agency does not do so.
And it is easy to envision more tailored solutions OSHA could have explored. It might,
for example, have considered a standard aimed at the most vulnerable workers; or an exemption
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for the least. The government’s own data show that unvaccinated workers between the ages of
18 and 29 bear a risk roughly equivalent to vaccinated persons between 50 and 64. See Ctr. for
Disease Control, Rates of COVID-19 Cases and Deaths by Vaccination Status (last visited Dec.
16,
2021),
https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status;
https://perma.cc/8SU2-SVLZ. Or it might have considered a standard aimed at specific
industries or types of workplaces with the greatest risk of COVID-19 exposure. Congress told
the Secretary to “give due regard” to the need for standards “for particular industries” and types
of “workplaces or work environments.” 29 U.S.C. § 655(g). And OSHA acknowledges that
death rates are higher in “[c]ertain occupational sectors,” 86 Fed. Reg. at 61,415; yet its rule
never considers what results would obtain from targeting those sectors alone. Would these, or
other alternatives, have achieved similar results? We do not know because OSHA did not ask.
OSHA counters that given the COVID-19 emergency, rough-cut mandates are the best it
can do. I see two problems with OSHA’s assertion. First, even an emergency standard must
consider “obvious distinctions” among those it regulates. Dry Color, 486 F.2d at 105. Here,
there are many, none reflected in the emergency rule. Second, the agency’s claim of emergency
rings hollow. It waited nearly two years since the beginning of the pandemic and nearly one year
since vaccines became available to the public to issue its vaccinate-or-test mandate. The agency
does not explain why, in that time, it could not have explored more finely tuned approaches.
The majority opinion contends that to require more of OSHA would contradict the point
of an emergency standard. But it offers no support for this proposition. It cannot be found in the
text of § 655 itself. Indeed, as discussed, the only distinction apparent from the statutory text is
that emergency standards should be more tailored to the problem, not less. The majority cites
Industrial Union for the proposition that “OSHA may lean ‘on the side of overprotection rather
than underprotection’ when promulgating an ETS.” Maj. Op. at 28 (quoting Indus. Union,
448 U.S. at 656). But that case did not review an emergency standard, and in any event, the
quoted language refers to “us[ing] conservative assumptions in interpreting the data” underlying
a risk assessment. Indus. Union, 448 U.S. at 656. It says nothing about excusing OSHA from
considering alternative means. Perhaps, instead, the majority relies on a bit of intuition;
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Nos. 21-7000, et al.
In re: MCP No. 165, Occupational Safety &
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
Page 48

circumstances demanding swift action often produce a less measured response. That may be
true, but only so far as it goes. Surely, when an agency fails to treat a situation as an emergency,
we should refuse to afford it any extra bit of deference, regardless of what label it attaches. See
Fla. Peach Growers, 489 F.2d at 130–31 (addressing exposure to pesticides that had been used
for years was not an emergency). Here, OSHA waited well over a year to respond to, in the
agency’s words, “the biggest threat to employees in OSHA’s more than 50-year history.”
86 Fed. Reg. at 61,424. To be sure, the agency may have had reasons for its wait-and-see
approach—hoping individuals would vaccinate voluntarily, for example. Id. at 61,431–32. But
that is beside the point. What matters is that the agency had plenty of time to consider and
develop more tailored responses, belying any notion that its blunt approach is merely the
expected product of an unexpected emergency.
Having failed to explore whether other feasible alternatives would have allowed him to
tackle the problem, the Secretary cannot show that his solution is “necessary”; nor is he able to
survive the requirements of “hard look” review. See Asbestos Info., 727 F.2d at 421 (When
reviewing an emergency standard, we must “take a ‘harder look’ . . . than we would if we were
reviewing the action under the more deferential arbitrary and capricious standard applicable to
agencies governed by the [APA].”).
b. Grave Danger in the Workplace
This case can be resolved on the ground that the Secretary is unlikely to be able to show
that the mandate was necessary. But there are also significant concerns with OSHA’s
determination that all unvaccinated employees face grave danger from exposure to the virus in
the workplace. 29 U.S.C. § 655(c)(1).
Grave danger. “Grave danger” comprises two meanings. First, severity: A “grave
danger” is a risk of “incurable, permanent, or fatal consequences to workers.” Fla. Peach
Growers, 489 F.2d at 132. The agency determined that symptomatic cases of COVID-19 can
cause such consequences, 86 Fed. Reg. at 61,408, and no one seriously questions that finding.
But the statutory concept of “danger,” or risk, also carries a second connotation—the likelihood
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Nos. 21-7000, et al.
In re: MCP No. 165, Occupational Safety &
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
Page 49

of its occurrence. See Asbestos Info., 727 F.2d at 424 (noting “gravity” includes “the number of
workers likely to suffer [severe] consequences”); Fla. Peach Growers, 489 F.2d at 132
(measuring danger “relative to the mass of agricultural workers in contact with treated foliage”).
I question whether the Secretary has made this second showing—that all covered employees
have a high risk both of contracting COVID-19 and suffering severe consequences from it.
The agency must provide substantial evidence supporting the risk it has identified and
give reasons for the conclusions it has drawn. Asbestos Info., 727 F.2d at 421; see also Dry
Color, 486 F.2d at 105–06. Substantial evidence is that which “a reasonable mind might accept
as adequate to support a conclusion.” Asbestos Info., 727 F.2d at 421 (quoting Consol. Edison
Co. v. NLRB, 305 U.S. 197, 229 (1938)). Here, a quick look at the evidence raises an eyebrow.
OSHA has determined that no vaccinated worker is in “grave danger,” whereas all unvaccinated
workers are. 86 Fed. Reg. at 61,434, 61,419. But the government’s own data reveal that the
death rate for unvaccinated people between the ages of 18 and 29 is roughly equivalent to that of
vaccinated persons between 50 and 64. See Rates of COVID-19 Cases and Deaths by
Vaccination Status, supra, at 10.5 So an unvaccinated 18-year-old bears the same risk as a
vaccinated 50-year-old. And yet, the 18-year-old is in grave danger, while the 50-year-old is not.
One of these conclusions must be wrong; either way is a problem for OSHA’s rule.
In the Workplace. OSHA’s authority extends only so far as Congress provides. And
Congress has clearly marked the perimeter of OSHA’s authority: the workplace walls. See
29 U.S.C. § 651(a) (“work situations”); id. § 651(b) (“occupational safety and health standards”)
(“working conditions”); see also Steel Joint Inst. v. Occupational Safety & Health Admin.,
287 F.3d 1165, 1167 (D.C. Cir. 2002) (“[T]he Act authorizes OSHA to regulate only the
employer’s conduct at the worksite.”).
The virus that causes COVID-19 is not, of course, uniquely a workplace condition. Its
potency lies in the fact that it exists everywhere an infected person may be—home, school, or
grocery store, to name a few. So how can OSHA regulate an employee’s exposure to it?

5Hospitalization rates corresponding to these age groups is not readily available from the CDC.
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Nos. 21-7000, et al.
In re: MCP No. 165, Occupational Safety &
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
Page 50

OSHA answers that it has authority to protect employees from general types of hazards
that may occur both inside and outside of the workplace. It may, for example, protect employees
from the danger of workplace fire, even though every person in America has some risk of injury
by fire outside the workplace. See, e.g., 29 C.F.R. § 1910.157 (requiring fire extinguishers in the
workplace). Sure. But one’s exposure to fire may be easily differentiated by location, and
OSHA has heretofore respected that its regulatory authority extends no further than the
workplace walls. In Industrial Union, for example, the Court noted that although “[t]he entire
population of the United States is exposed to small quantities of benzene” in the air, OSHA
sought to regulate the increased risk of exposure to benzene only in the workplace. 448 U.S. at
615, 622–23. And the Fourth Circuit upheld OSHA’s Occupational Noise Exposure standard
because workers faced “sustained noise of great intensity” at work, which did not exist at those
levels outside the workplace. Forging Indus. Ass’n v. Sec’y of Lab., 773 F.2d 1436, 1442–44
(4th Cir. 1985) (en banc) (“The hazard is identified as sustained noise of great intensity-85 db
and above. Non-occupational noise of that intensity sustained over a period of eight hours each
day is hard to imagine.”).
Yet OSHA admits that it “cannot state with precision the total number of workers in our
nation who have contracted COVID-19 at work.” 86 Fed. Reg. at 61,424. And it has not
identified any particular rate or risk of workplace exposure to COVID-19. So instead OSHA
determined that each of the 26 million unvaccinated workers are “in grave danger” based on
“current mortality data show[ing] that unvaccinated people of working age have a 1 in 202
chance of dying when they contract COVID-19.” Id. I can find no example of a court accepting
generalized statistics like these, totally untied to the workplace. Cf. Asbestos Info., 727 F.2d at
425–26. “The ‘grave danger’ and ‘necessity’ findings must be based on evidence of actual,
prevailing [workplace] conditions, i.e., current levels of employee exposure.” UAW v. Donovan,
590 F. Supp. 747, 751 (D.D.C. 1984).
The risk the Secretary calculated to support his “grave danger” finding was in no way
tied to any workplace. Instead, he calculated the risk of being a person “of working age” in
America. 86 Fed. Reg. at 61,424. Indeed, in OSHA’s eyes, the risk to an employee who starts a
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Nos. 21-7000, et al.
In re: MCP No. 165, Occupational Safety &
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
Page 51

job today is no more “grave” than it was yesterday, before she entered the workforce; and,
should she quit tomorrow, it will remain the same. In other words, the Secretary did not
calculate the number of people who will contract COVID-19 at work; he calculated the number
of people who happen to work who would, in any event, contract COVID-19. That kind of risk
assessment is hard to justify as an “occupational safety and health standard[].” 29 U.S.C.
§ 651(b)(3). And it is hard to square with Congress’s codified mission statement for the
Agency: to prevent “personal injuries and illnesses arising out of work situations.” Id. § 651(a).
And what of the solution? Here, OSHA has ventured into entirely new territory. An
authority to protect “employees” from a “grave danger” encountered in the workplace, id. at
§ 655(c)(1), is most naturally read to place a workplace boundary on the solution. Flame-
retardant clothing may be mandated at work, but not also at home. And that is true even if taking
such precautions at home would save many “employee” lives.
OSHA has never before acted otherwise. It has consistently regulated workplace hazards
with workplace solutions. See, e.g., 29 C.F.R § 1926.96 (steel-toe boots); id. § 1926.97
(electrical protective equipment); id. § 1926.100 (hard hats); id. § 1926.101 (ear protective
devices); id. § 1926.102 (eye and face protection); id. § 1926.103 (respirators). Even its one
foray into vaccines was offered to, but not required of, employees who had been exposed to
Hepatitis B in the workplace. See, e.g., id. § 1910.1030(f)(2)(i). Here, employers, not
employees, control any non-vaccine option in the first instance; and OSHA has been candid that
it has stacked the deck in favor of vaccination. 86 Fed. Reg. at 61,437. OSHA has alerted us to
no prior attempt on its part to mandate a solution that extends beyond the workplace walls—
much less a permanent and physically intrusive one, promulgated on an emergency basis,
without any chance for public participation. But that it is what OSHA has done here. A vaccine
may not be taken off when the workday ends; and its effects, unlike this rule, will not expire in
six months.
Accordingly, I question whether the Secretary can show that OSHA’s risk assessment
and solution are tied to its authority—to protect employees against grave danger in the
workplace.
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Nos. 21-7000, et al.
In re: MCP No. 165, Occupational Safety &
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
Page 52

2. Major Questions Doctrine
If there were doubt, the major questions doctrine tells us how to respond. Congress must
“speak clearly if it wishes to assign to an agency decisions of vast ‘economic and political
significance.’” Util. Air Reg. Grp. v. EPA, 573 U.S. 302, 324 (2014) (quoting FDA v. Brown &
Williamson Tobacco Corp., 529 U.S. 120, 160 (2000)). And we should be skeptical when an
agency suddenly discovers “in a long-extant statute an unheralded power to regulate a significant
portion of the American economy.” Id. (quotation marks omitted).
OSHA has never issued an emergency standard of this scope. Each of this rule’s few
predecessors addressed discrete problems in particular industries. See 48 Fed. Reg. 51,086,
51,087–93 (Nov. 4, 1983) (targeting workplaces where “asbestos is handled,” specifically
375,000 employees in manufacturing, construction, fabrication, brake repair, and shipbuilding);
43 Fed. Reg. 2,586, 2,593 (Jan. 17, 1978) (targeting acrylonitrile manufacturing, acrylic fiber
production, and similar activities with the “highest exposure” to acrylonitrile); 42 Fed. Reg.
45,536, 45,536 (Sept. 9, 1977) (targeting DBCP manufacturers, specifically 2,000 to 3,000
employees in a handful of companies); 42 Fed. Reg. 22,516, 22,517–22 (May 3, 1977) (targeting
150,000 employees in the chemical, printing, lithograph, rubber, paint, varnish, stain remover,
adhesive, and petroleum industries with high exposure to Benzene, but exempting retail gas
stations); 41 Fed. Reg. 24,272, 24,275 (June 15, 1976) (targeting 2,305 commercial divers);
39 Fed. Reg. 12,342, 12,343 (Apr. 5, 1974) (targeting vinyl chloride manufacturers, processers,
and storers); 38 Fed. Reg. 10,929, 10,929 (May 3, 1973) (targeting 14 carcinogens when
manufactured, processed, used, repackaged, released, or otherwise handled, as requested by oil,
chemical, and atomic workers); 38 Fed. Reg. 17,214, 17,216 (June 29, 1973) (targeting field
workers exposed to 12 pesticides, but limited to crops of apples, citrus, grapes, peaches, and
tobacco); 36 Fed. Reg. 23,207, 23,207 (Dec. 7, 1971) (targeting workplaces with extremely high
levels of asbestos). Most of those were challenged in court and only one of those survived. Now
the Secretary claims authority to impose a vaccinate-or-test mandate across “all industries” on
84 million Americans (26 million unvaccinated) in response to a global pandemic that has been
raging for nearly two years. 86 Fed. Reg. at 61,424. But no congressional grant of authority
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Nos. 21-7000, et al.
In re: MCP No. 165, Occupational Safety &
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
Page 53

does what the Supreme Court requires in such circumstances: speak with “exceedingly clear
language.” Ala. Ass’n of Realtors, 141 S. Ct. at 2489.
The majority deems the major questions doctrine inapplicable, first because, in its eyes,
OSHA’s authority to undertake a nationwide vaccine-or-test mandate is “unambiguous.” Maj.
Op. at 16. It rests that conclusion primarily on the fact that OSHA has been regulating
workplace health and safety since 1970. But the major questions doctrine is not about the age of
the agency; and it is not only about the kind of power but also the scope or degree. Claiming that
it made no such error, the majority doubles down with examples of OSHA exercising power
similar in kind and calls that “scope.” But no matter how many times OSHA has regulated
discrete illnesses in particular workspaces, this emergency rule remains a massive expansion of
the scope of its authority. In Brown & Williamson, the FDA had been regulating “drugs” and
“devices” for 58 years. 529 U.S. at 125. And regulating nicotine seemed to fit in the FDA’s
wheelhouse. See id. at 127. Nonetheless, the Court denied the FDA’s authority to make “a
policy decision of such economic and political magnitude”—even one in the agency’s ken, and
even though tobacco was “perhaps the single most significant threat to public health in the
United States” at the time.6 Id. at 133, 161.
Just months ago, the Supreme Court rejected a similar attempt by a different agency to
take the pandemic into its own hands. See Ala. Ass’n of Realtors, 141 S. Ct. at 2486. The CDC
had imposed an eviction moratorium for any counties with high levels of COVID-19
transmission, citing its authority in the Public Health Act to make “such regulations as . . . are
necessary to prevent the introduction, transmission, or spread of communicable diseases from
foreign countries.” Id. at 2487. Deciding that a challenge to the moratorium was “virtually
certain to succeed on the merits,” the Court found that even if the provision could be read that

6The majority thinks Brown & Williamson is distinguishable because there Congress had directly spoken
on the issue of tobacco, which was further evidence that the FDA had no such authority. See 529 U.S. at 137–39.
However, in Utility Air Regulatory Group, the Supreme Court reaffirmed the language in Brown & Williamson and
applied it even where Congress had been silent. See 573 U.S. at 307, 324 (finding that an EPA determination “that
its motor-vehicle greenhouse-gas regulations automatically triggered permitting requirements” was an “enormous
and transformative expansion” in authority that triggered Brown & Williamson). Utility Air Regulatory Group is yet
another example of the Supreme Court applying the major questions doctrine to a regulation similar in kind but with
an increased scope.
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Nos. 21-7000, et al.
In re: MCP No. 165, Occupational Safety &
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
Page 54

way, “the sheer scope of the CDC’s claimed authority” belied the government’s interpretation.
Id. at 2489.
The majority gives short shrift to this very recent precedent, calling the major questions
doctrine a “seldom-used . . . exception to Chevron deference.” Maj. Op. at 14. It is hard to see
how that can be right when Alabama Association of Realtors just applied the doctrine and
Chevron made no appearance in the case. The majority protests that the doctrine is “hardly a
model of clarity” and that “economic and political significance” is undefined. Id. Maybe so.
Yet it is hard to think of a more apt comparison than the one the Supreme Court just gave us to
follow. Finding it to be a power of “vast economic and political significance,” the Court
emphasized that the CDC’s moratorium covered “80% of the country, including between 6 and
17 million tenants,” all to “combat[] the spread of COVID-19.” Ala. Ass’n of Realtors, 141 S.
Ct. at 2489–90. OSHA’s rule covers two-thirds of the private sector, including 84 million
workers (26 million unvaccinated), also to combat COVID-19. 86 Fed. Reg. at 61,424–41. If it
is not clear on its face that OSHA’s vaccinate-or-test mandate covering most of the country is
significant, then Alabama Association of Realtors tells us it is.
Finally, the majority tries to escape the doctrine by claiming that the Secretary’s authority
is carefully circumscribed by the requirements in § 655 that the rule be “necessary” to combat a
“grave danger,” and that OSHA has “honored those parameters” by using its power infrequently.
Maj. Op. at 16. Two short responses are in order. One, the provision in Alabama Association of
Realtors was similarly circumscribed; the CDC could act only when it was “necessary” to
prevent the “spread of communicable disease,” and it had “rarely . . . invoked” its power.
141 S. Ct. at 2487. Two, the fact that § 655 “narrowly circumscribe[s]” OSHA’s authority,
Indus. Union, 448 U.S. at 651, and that its assertions of power in the past have been limited,
supports a restrictive reading, not an expansive one.
A last point bears mention. Congress may enlist the help of administrative agencies to
implement and enforce the laws, as it has done here. See Gundy v. United States, 139 S. Ct.
2116, 2123 (2019). But there are limits to how much Congress may delegate. See id. And the
greater the putative delegation of power, the less discretion an agency has when exercising it.
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Nos. 21-7000, et al.
In re: MCP No. 165, Occupational Safety &
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
Page 55

See Whitman v. Am. Trucking Ass’ns, 531 U.S. 457, 475 (2001) (“[T]he degree of agency
discretion that is acceptable varies according to the scope of the power congressionally
conferred.”).
Here, the Secretary asks for maximum authority and maximum discretion; he wants to
issue a rule of national import, covering two-thirds of American workers, and he wants to do it
without clear congressional authorization, without even public notice and comment, and with a
capacious understanding of necessity. Such a combination of authority and discretion is
unprecedented, and the Secretary is unlikely to show that he has been granted it.
B. Other Stay Factors
Petitioners have shown a likelihood of success on the merits of their challenge to the
emergency rule. That factor is the most important; but the other factors favor the stay as well.
Will petitioners be irreparably harmed absent a stay? Yes. Nken v. Holder, 556 U.S.
418, 434 (2009). Consider just two classes of petitioners. First, individuals. Without a stay,
they will be forced to decide whether to get vaccinated. In some cases, employers may permit
employees to undergo weekly testing and wear a mask. But some will fire those who are not
vaccinated, rather than deal with the recordkeeping hassles of the testing requirement. In those
instances, the individuals will be irreparably harmed, either by loss of livelihood or an
unwelcome vaccination. And even if given the choice by her employer, an individual petitioner
might reluctantly submit to vaccination, rather than incur a weekly hit to her finances and to her
time. And if it turns out she did so due to an invalid regulation, she will have been irreparably
harmed.
Second, businesses. The business petitioners say they will be harmed in various ways,
including unrecoverable compliance costs and loss of employees amidst a labor shortage. For
example, one petitioner, Oberg Industries, says that it will incur more than “$22 million in lost
revenue per year,” and that the vaccinate-or-test mandate “will imperil Petitioner’s business
going forward given significant labor market shortages.” Docket Nos. 21-7000, 21-4112,
Motion for Emergency Stay at 2. Currently, the company has 21 open positions and, according
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Nos. 21-7000, et al.
In re: MCP No. 165, Occupational Safety &
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
Page 56

to Oberg, “studies show that at least seven million affected workers report that they definitely
will not get the vaccine.” Id. The vaccinate-or-test mandate will exacerbate these shortages,
with Oberg estimating that it will lose “200 employees—approximately 30% of its existing
workforce.” Id. at 2–3. The papers before this court are filled with similar stories. There is no
question that if these harms occur, they will be irreparable.
OSHA responds that the administrative record it compiled does not support the alleged
severity of petitioners’ harms. Of course the record is silent as to petitioners’ concerns, given
that the emergency standard circumvents any public input. And while OSHA says its projected
costs are much lower than petitioners’, the projected costs are not de minimis, ranging from as
little as $2,000 to almost $900,000 per entity, with a combined projected cost of almost
$3 billion. 86 Fed. Reg. at 61,493.
Would the stay substantially injure OSHA and where does the public interest lie? Nken,
556 U.S. at 434. These two factors merge when the government is a party. Id. at 435. It is hard
to find harm to OSHA from delay, as it waited almost two years since the pandemic began, and
nearly a year after vaccines became publicly available, to issue the mandate. That is not to
mention the almost two-month delay between the President’s mandate announcement and the
issuance of the emergency standard.
As for the societal costs of the pandemic, few could dispute their size and scope.
To focus on just one, in many states, the healthcare system is being overrun and many healthcare
workers report both a physical and emotional toll from the relentless effort of caring for the sick
and dying. See Michigan’s Hospitals Near Breaking Point: ‘We Can’t Take Care of Our
Patients as We
Need’,
The
Detroit
News
(last
visited
Dec.
15,
2021),
https://www.detroitnews.com/in-depth/news/nation/coronavirus/2021/12/15/michigan-hospitals-
crisis-health-care-workers-exhausted-covid-19-pandemic/6462036001/. The agency record in
this case contains substantial evidence that we could give them some rest if more of us rolled up
our sleeves. But the Secretary himself claims no authority to regulate for these ends. He cannot
even regulate for the sake of the vaccinated; they are not in “grave danger.” Instead, the mandate
is aimed directly at protecting the unvaccinated from their own choices. Vaccines are freely
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Nos. 21-7000, et al.
In re: MCP No. 165, Occupational Safety &
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
Page 57

available, and unvaccinated people may choose to protect themselves at any time. And because
the Secretary likely lacks congressional authority to force them to protect themselves, the
remaining stay factors cannot tip the balance. See Tiger Lily, 992 F.3d at 524.
* * *
I would deny OSHA’s motion to dissolve the stay.
Case: 21-7000 Document: 386-2 Filed: 12/17/2021 Page: 57

EXHIBIT 2

United States Court of Appeals
for the Fifth Circuit

No. 21-60845

BST Holdings, L.L.C.; RV Trosclair, L.L.C.; Trosclair
Airline, L.L.C.; Trosclair Almonaster, L.L.C.;
Trosclair and Sons, L.L.C.; Trosclair ; Trosclair,
Incorporated; Trosclair Carrollton, L.L.C.; Trosclair
Claiborne, L.L.C.; Trosclair Donaldsonville, L.L.C.;
Trosclair Houma, L.L.C.; Trosclair Judge Perez, L.L.C.;
Trosclair Lake Forest, L.L.C.; Trosclair Morrison,
L.L.C.; Trosclair Paris, L.L.C.; Trosclair Terry, L.L.C.;
Trosclair Williams, L.L.C.; Ryan Dailey; Jasand
Gamble; Christopher L. Jones; David John Loschen;
Samuel Albert Reyna; Kip Stovall; Answers in Genesis,
Incorporated; American Family Association,
Incorporated; Burnett Specialists; Choice Staffing,
L.L.C.; Staff Force, Incorporated; Leadingedge
Personnel, Limited; State of Texas; HT Staffing,
Limited; doing business as HT Group; The State of
Louisiana; Cox Operating, L.L.C.; Dis-Tran Steel,
L.L.C.; Dis-Tran Packaged Substations, L.L.C.; Beta
Engineering, L.L.C. Optimal Field Services, L.L.C.; The
State of Mississippi; Gulf Coast Restaurant Group,
Incorporated; The State of South Carolina; The State
of Utah; Word of God Fellowship, Incorporated, doing
busines as Daystar Television Network,

Petitioners,

versus

Occupational Safety and Health Administration,
United States Department of Labor; United States
United States Court of Appeals
Fifth Circuit
FILED
November 12, 2021

Lyle W. Cayce
Clerk

No. 21-60845
2
Department of Labor; Martin J. Walsh, Secretary, U.S.
Department of Labor; Douglas Parker, in his Official
Capacity as Assistant Secretary of Labor for
Occupational Safety and Health,

Respondents.

Petition for Review of
Occupational Safety and Health Administration
Emergency Temporary Standard

Before Jones, Duncan, and Engelhardt, Circuit Judges.
Kurt D. Engelhardt, Circuit Judge:
The Occupational Safety and Health Administration (OSHA)
“reasonably determined” in June 2020 that an emergency temporary
standard (ETS) was “not necessary” to “protect working people from
occupational exposure to infectious disease, including COVID-19.” In re
AFL-CIO, 2020 WL 3125324, at *1 (D.C. Cir. June 11, 2020). This was not
the first time OSHA had done this; it has refused several times to issue ETSs
despite legal action urging it do so. See, e.g., In re Int’l Chem. Workers Union,
830 F.2d 369 (D.C. Cir. 1987) (per curiam). In fact, in its fifty-year history,
OSHA has issued just ten ETSs.1 Six were challenged in court; only one
survived.2 The reason for the rarity of this form of emergency action is

1 Cong. Rsch. Serv., Occupational Safety and Health
Administration (OSHA): Emergency Temporary Standards (ETS)
and
COVID-19,
at
34
tbl.
A-1
(Nov.
10,
2021),
available
at
https://crsreports.congress.gov/product/pdf/R/R46288.
2 It bears noting at the outset that most of the few ETSs issued by OSHA were
immediately stayed pending merits review. See Asbestos Info. Ass’n/N. Am. v. OSHA, 727
F.2d 415, 418 (5th Cir. 1984); Indus. Union Dep’t, AFL-CIO v. Bingham, 570 F.2d 965, 968
(D.C. Cir. 1977); Taylor Diving Salvage Co. v. U.S. Dep’t of Lab., 537 F.2d 819, 820–21 (5th

No. 21-60845
3
simple: courts and the Agency have agreed for generations that
“[e]xtraordinary power is delivered to [OSHA] under the emergency
provisions of the Occupational Safety and Health Act,” so “[t]hat power
should be delicately exercised, and only in those emergency situations which
require it.” Fla. Peach Growers Ass’n v. U.S. Dep’t of Lab., 489 F.2d 120, 129–
30 (5th Cir. 1974).
This case concerns OSHA’s most recent ETS—the Agency’s
November 5, 2021 Emergency Temporary Standard (the “Mandate”)
requiring employees of covered employers to undergo COVID-19
vaccination or take weekly COVID-19 tests and wear a mask.3 An array of
petitioners seeks a stay barring OSHA from enforcing the Mandate during
the pendency of judicial review. On November 6, 2021, we agreed to stay the
Mandate pending briefing and expedited judicial review. Having conducted
that expedited review, we reaffirm our initial stay.
I.
OSHA promulgated its much anticipated4 vaccine mandate on
November 5, 2021. Framed as an ETS, the Mandate requires all employers
of 100 or more employees to “develop, implement, and enforce a mandatory
COVID-19 vaccination policy” and require any workers who remain

Cir. 1976) (per curiam); Fla. Peach Growers Ass’n v. U.S. Dep’t of Lab., 489 F.2d 120, 126
(5th Cir. 1974).
3 See COVID-19 Vaccination and Testing; Emergency Temporary Standard, 86
Fed. Reg. 61,402 (Nov. 5, 2021) (to be codified at 29 C.F.R. pts. 1910, 1915, 1917, 1918,
1926, and 1928).
4 Debates over the Biden Administration’s forthcoming vaccine mandate roiled the
country throughout much of the Fall. For obvious reasons, the Mandate affects every
person in America in one way or another.

No. 21-60845
4
unvaccinated to “undergo [weekly] COVID-19 testing and wear a face
covering at work in lieu of vaccination.” 86 Fed. Reg. 61,402, 61,402.
On the afternoon of the Mandate’s publication, a diverse group of
petitioners (including covered employers, States, religious groups, and
individual citizens) moved to stay and permanently enjoin the mandate in
federal courts of appeals across the nation. Finding “cause to believe there
are grave statutory and constitutional issues with the Mandate,” we
intervened and imposed a temporary stay on OSHA’s enforcement of the
Mandate. For ease of judicial review, and in light of the pressing need to act
immediately, we consolidated our court’s petitions under the case number
captioned above.
Many of the petitioners are covered private employers within the
geographical boundaries of this circuit.5 Their standing6 to sue is obvious—
the Mandate imposes a financial burden upon them by deputizing their
participation in OSHA’s regulatory scheme, exposes them to severe financial
risk if they refuse or fail to comply, and threatens to decimate their
workforces (and business prospects) by forcing unwilling employees to take
their shots, take their tests, or hit the road.

5 Because these petitioners are the targets of the Mandate and bear the brunt of
OSHA’s regulatory power, we principally analyze the petitions from their perspective.
This is not to say that the claims of other petitioners such as States or individual citizens
would be any less successful on a thorough analysis.
6 “Only one of the petitioners needs to have standing to permit us to consider the
petition for review.” Massachusetts v. EPA, 549 U.S. 497, 518 (2007).

No. 21-60845
5
The petitioners seek a stay—and ultimately a permanent injunction—
of the Mandate’s enforcement pending full judicial review of the Mandate.
We address their request for a stay today.7
II.

The “traditional stay factors . . . govern a request for a stay pending
judicial review.” Nken v. Holder, 556 U.S. 418, 426 (2009). Under the
traditional stay standard, a court considers four factors: “(1) whether the stay
applicant has made a strong showing that he is likely to succeed on the merits;
(2) whether the applicant will be irreparably injured absent a stay; (3)
whether issuance of the stay will substantially injure the other parties
interested in the proceeding; and (4) where the public interest lies.” Hilton
v. Braunskill, 481 U.S. 770, 776 (1987).

Each of these factors favors a stay here.
A.

We first consider whether the petitioners’ challenges to the Mandate
are likely to succeed on the merits. For a multitude of reasons, they are.

7 Our November 6, 2021 stay order preserved the status quo during the pendency
of briefing. The unusual procedural posture of this case makes for an unusual process.
Ordinarily, a federal plaintiff aggrieved by an adversary’s threatened course of action must
go to a district court to seek injunctive relief at the outset. In this ordinary scenario, a
preliminary injunction precedes a permanent injunction, and trial-court review precedes
appellate review. But this is not a typical case. Here, the statute giving OSHA the power to
issue emergency temporary standards like the Mandate also provides for direct and
immediate judicial review in “the United States court of appeals for the circuit wherein”
“[a]ny person who may be adversely affected by” an ETS “resides or has his principal
place of business.” See 29 U.S.C. § 655(f). Satisfied of our jurisdiction to proceed under
that provision, but mindful of our unusual procedural posture, we apply the traditional
factors for a stay pending judicial review and draw factual support from the attachments to
the pleadings, uncontested facts, and judicial notice.

No. 21-60845
6
We begin by stating the obvious. The Occupational Safety and Health
Act, which created OSHA, was enacted by Congress to assure Americans
“safe and healthful working conditions and to preserve our human
resources.” See 29 U.S.C. § 651 (statement of findings and declaration of
purpose and policy). It was not—and likely could not be, under the
Commerce Clause and nondelegation doctrine8—intended to authorize a
workplace safety administration in the deep recesses of the federal
bureaucracy to make sweeping pronouncements on matters of public health
affecting every member of society in the profoundest of ways. Cf. Ala. Ass’n
of Realtors v. HHS, 141 S. Ct. 2485, 2488–90 (2021) (per curiam).

On the dubious assumption that the Mandate does pass constitutional
muster—which we need not decide today9—it is nonetheless fatally flawed
on its own terms. Indeed, the Mandate’s strained prescriptions combine to
make it the rare government pronouncement that is both overinclusive
(applying to employers and employees in virtually all industries and
workplaces in America, with little attempt to account for the obvious
differences between the risks facing, say, a security guard on a lonely night
shift, and a meatpacker working shoulder to shoulder in a cramped
warehouse) and underinclusive (purporting to save employees with 99 or
more coworkers from a “grave danger” in the workplace, while making no
attempt to shield employees with 98 or fewer coworkers from the very same

8 The nondelegation doctrine constrains Congress’s ability to delegate its
legislative authority to executive agencies. See, e.g., Mistretta v. United States, 488 U.S. 361,
371–72 (1989) (“The Constitution +-*1$ ./#/BNO''' "$.'/$1 *2 -.# - $)"-)/
shall be vested in a Congress of the United States’ . . . )2 #1 '*)"$).$./ /#/B/#
integrity and maintenance of the system of government ordered by the Constitution’
mandate that Congress generally cannot delegate its legislative power to another Branch.”
(first quoting U.S. Const. art. I, § 1; then quoting Field v. Clark, 143 U.S. 649, 692
(1892))).
9 But see infra subsection II.A.2.f.

No. 21-60845
7
threat). The Mandate’s stated impetus—a purported “emergency” that the
entire globe has now endured for nearly two years,10 and which OSHA itself
spent nearly two months responding to11—is unavailing as well. And its
promulgation grossly exceeds OSHA’s statutory authority.
1.
After the President voiced his displeasure with the country’s
vaccination rate in September,12 the Administration pored over the U.S.
Code in search of authority, or a “work-around,”13 for imposing a national

10 As Justice Gorsuch recently observed, society’s interest in slowing the spread of
COVID-19 “cannot qualify as [compelling] forever,” for “[i]f human nature and history
teach anything, it is that civil liberties face grave risks when governments proclaim
indefinite states of emergency.” Does 1–3 v. Mills, --- S. Ct. ---, 2021 WL 5027177, at *3
(Oct. 29, 2021) (Gorsuch, J., dissenting); see also Fla. Peach Growers, 489 F.2d at 131
(situation ongoing for “last several years . . . fail[ed] to qualify for [OSHA] emergency
measures”).
11 The President announced his intention to impose a national vaccine mandate on
September 9, 2021. See, e.g., Kevin Liptak & Kaitlan Collins, Biden Announces New Vaccine
Mandates that Could Cover 100 Million Americans, CNN (Sept. 9, 2021),
https://www.cnn.com/2021/09/09/politics/joe-biden-covid-speech/index.html
LDB C1 )+/$ )/60/*0-+/$ ) $.2 -$)"/#$)6)4*0-- !0.'#.*./''*!0.6C
Biden said, his tone hardening toward Americans who still refuse to receive a vaccine
despite ample evidence of their safety and full approval of one . . . .”). OSHA issued the
Mandate nearly two months later, on November 5, 2021, and the Mandate itself
prominently features yet another two-month delay. One could query how an “emergency”
could prompt such a “deliberate” response. In similar cases, we’ve held that OSHA’s
failure to act promptly “does not conclusively establish that a situation is not an
emergency,” but “may be evidence that a situation is not a true emergency.” Asbestos Info.,
727 F.2d at 423 (emphasis added).
12 See supra note 11.
13 On September 9, 2021, White House Chief of Staff Ron Klain retweeted MSNBC
anchor Stephanie Ruhle’s tweet that stated, “OSHA doing this vaxx mandate as an
emergency workplace safety rule is the ultimate work-around for the Federal govt to require
vaccinations.” See, e.g., Pet’rs Burnett Specialists, Choice Staffing, LLC, and Staff Force
Inc.’s Reply Brief at 4 (emphasis added).

No. 21-60845
8
vaccine mandate. The vehicle it landed on was an OSHA ETS. The statute
empowering OSHA allows OSHA to bypass typical notice-and-comment
proceedings for six months by providing “for an emergency temporary
standard to take immediate effect upon publication in the Federal Register”
if it “determines (A) that employees are exposed to grave danger from
exposure to substances or agents determined to be toxic or physically harmful
or from new hazards, and (B) that such emergency standard is necessary to
protect employees from such danger.” 29 U.S.C. § 655(c)(1).
As the name suggests, emergency temporary standards “are an
Bunusual response’ /* B 3 +/$*)'$-0(./) .7C” Int’l Chem. Workers,
830 F.2d at 371 (quoting Pub. Citizen Health Rsch. Grp. v. Auchter, 702 F.2d
1150, 1155 (D.C. Cir. 1983)). Thus, courts have uniformly observed that
OSHA’s authority to establish emergency temporary standards under
§ jiiLMD$.)B 3/-*-$)-4+*2 -C/#/$./* B '$/ '4 3 -$. C$)
*)'4 -/$)B'$($/ .$/0/$*).7CEId. at 370 (quoting Pub. Citizen, 702 F.2d
at 1155).14
But the Mandate at issue here is anything but a “delicate[] exercise[]”
of this “extraordinary power.” Cf. Pub. Citizen, 702 F.2d at 1155. Quite the
opposite, rather than a delicately handled scalpel, the Mandate is a one-size-
fits-all sledgehammer that makes hardly any attempt to account for
differences in workplaces (and workers) that have more than a little bearing
on workers’ varying degrees of susceptibility to the supposedly “grave
danger” the Mandate purports to address.

14 The Agency has thus conceded in the past that “[t]he OSH Act does not
authorize OSHA to issue sweeping health standards to address entire classes of known and
unknown infectious diseases on an emergency basis without notice and comment.” See
Department of Labor’s Resp. to the Emergency Pet. for a Writ of Mandamus at 33–34, In
re AFL-CIO, No. 20-1158 (D.C. Cir. May 29, 2020) [hereinafter OSHA D.C. Circuit Brief].

No. 21-60845
9
2.
Thus, as § 655(c)(1) plainly provides, to be lawfully enacted, an ETS
must: (1) address “substances or agents determined to be toxic or physically
harmful”—or “new hazards”—in the workplace; (2) show that workers are
exposed to such “substances,” “agents,” or “new hazards” in the
workplace; (3) show that said exposure places workers in “grave danger”;
and (4) be “necessary” to alleviate employees’ exposure to gravely
dangerous hazards in the workplace. As we have noted in the past, the
precision of this standard makes it a difficult one to meet. See Fla. Peach
Growers, 489 F.2d at 130 (observing that OSHA’s ETS authority “requires
determination of danger from exposure to harmful substances, not just a
danger of exposure; and, not exposure to just a danger, but to a grave danger;
and, not the necessity of just a temporary standard, but that an emergency
[temporary] standard is necessary”).15
(a)

In its brief, Texas makes a compelling argument that § 655(c)(1)’s
neighboring phrases “substances or agents” and “toxic or physically
harmful” place an airborne virus beyond the purview of an OSHA ETS in the
first place. To avoid “giving unintended breadth to the Acts of Congress,”
courts “rely on the principle of noscitur a sociis—a word is known by the
company it keeps.” Yates v. United States, 574 U.S. 528, 543 (2015) (cleaned
up). Here, OSHA’s attempt to shoehorn an airborne virus that is both widely
present in society (and thus not particular to any workplace) and non-life-

15 In prior litigation, OSHA acknowledged that many “workplaces” covered by a
COVID-19 ETS “are not merely workplaces,” but are also “stores, restaurants, and other
places occupied by workers and the general public alike, in which the measures called for
require a broader lens—and at times a broader mandate—than available to OSHA.” See
OSHA D.C. Circuit Brief at 20.

No. 21-60845
10
threatening to a vast majority of employees into a neighboring phrase
connoting toxicity and poisonousness is yet another transparent stretch. Other
cases involving OSHA (though not ETSs per se) shed further light on the
intended meaning of these terms. See, e.g., UAW v. OSHA, 938 F.2d 1310,
1314 (D.C. Cir. 1991). See generally Indus. Union Dep’t, AFL-CIO v. Am.
Petroleum Inst., 448 U.S. 607 (1980). Any argument OSHA may make that
COVID-19 is a “new hazard[]” would directly contradict OSHA’s prior
representation to the D.C. Circuit that “[t]here can be no dispute that
COVID-19 is a recognized hazard.” See OSHA D.C. Circuit Brief at 25
(emphasis added).
(b)

A natural first step in enacting a lawful ETS is to show that employees
covered by the ETS are in fact exposed to the dangerous substances, agents,
or hazards at issue—here, COVID-19. See, e.g., Int’l Chem. Workers, 830 F.2d
at 371 (noting OSHA’s stated 1$ 2 D/#/ !$)$)" *! B"-1 )" -C /*
support an ETS be based upon exposure in actual levels found in the
workplace”). As it pertains to the vast majority of private employees covered
by the Mandate, however, OSHA fails to meet this threshold burden. In
defending the Mandate before this court, the Government credits OSHA
with “describ[ing] myriad studies showing workplace [COVID-emOB'0./ -.C
)B*0/- &.C)*/# -.$")$!$)/B 1$ ) *!2*-&+' /-).($..$*)C
)B 3+osure.’” See Resp’ts’ Opp’n to Emergency Stay Mot. at 8. But this
misses the mark, as OSHA is required to make findings of exposure—or at
least the presence of COVID-19—in all covered workplaces.
Of course, OSHA cannot possibly show that every workplace covered
by the Mandate currently has COVID-positive employees, or that every
industry covered by the Mandate has had or will have “outbreaks.” As

No. 21-60845
11
discussed below, this kind of overbreadth plagues the Mandate generally. See
infra subsection II.A.2.d.
(c)
Equally problematic, however, is that it remains unclear that COVID-
19—however tragic and devastating the pandemic has been—poses the kind
of grave danger § 655(c)(1) contemplates. See, e.g., Int’l Chem. Workers, 830
F.2d at 371 (noting that OSHA itself *) *)'0 D/#//* B"-1
danger,’ it is not sufficient that a chemical, such as cadmium, can cause cancer
or kidney damage at a high level of exposure” (emphasis added)). For starters,
the Mandate itself concedes that the effects of COVID-19 may range from
“mild” to “critical.” As important, however, the status of the spread of the
virus has varied since the President announced the general parameters of the
Mandate in September. (And of course, this all assumes that COVID-19
poses any significant danger to workers to begin with; for the more than
seventy-eight percent16 of Americans aged 12 and older either fully or partially
inoculated against it, the virus poses—the Administration assures us—little
risk at all.) See, e.g., 86 Fed. Reg. 61,402, 61,402–03 (“COVID-19 vaccines
authorized or approved by the [FDA] effectively protect vaccinated
individuals against severe illness and death from COVID-19.”).
The Administration’s prior statements in this regard further belie the
notion that COVID-19 poses the kind of emergency that allows OSHA to take
the extreme measure of an ETS. In reviewing agency pronouncements,
courts need not turn a blind eye to the statements of those issuing such
pronouncements. See, e.g., FCC v. Fox Television Stations, Inc., 556 U.S. 502,
515 (2009). In fact, courts have an affirmative duty not to do so. It is thus

16 See CDC, Covid Data Tracker, https://covid.cdc.gov/covid-data-
tracker/#datatracker-home.

No. 21-60845
12
critical to note that the Mandate makes no serious attempt to explain why
OSHA and the President himself17 were against vaccine mandates before they
were for one here. See, e.g., Occupational Exposure to Bloodborne Pathogens,
54 Fed. Reg. 23,042, 23,045 (May 30, 1989) (“Health in general is an
intensely personal matter. . . . OSHA prefers to encourage rather than try to
force by governmental coercion, employee cooperation in [a] vaccination
program.”); Letter from Loren Sweatt, Principal Deputy Assistant Sec’y,
OSHA, to Richard L. Trumka, President, AFL-CIO at 3 (May 29, 2020)
[hereinafter Sweatt Letter] (acknowledging as a general matter that it “would
not be necessary for OSHA to issue an ETS to protect workers from
infectious diseases” because “OSHA lacks evidence to conclude that all
infectious diseases to which employees may be exposed at a workplace
*)./$/0/ B"-1 )" -C!*-2#$#)$.)++-*+-$/ - ( dy”).
Because it is generally “arbitrary or capricious” to “depart from a prior
policy sub silentio,” agencies must typically provide a “detailed explanation”
for contradicting a prior policy, particularly when the “prior policy has
engendered serious reliance interests.” FCC v. Fox, 556 U.S. at 515. OSHA’s
reversal here strains credulity, as does its pretextual basis.18 Such
shortcomings are all hallmarks of unlawful agency actions.

To be sure, “OSHA’s assessment of . . . scientifically complex [facts]
and its balancing of the competing policies that underlie the decision whether
to issue an ETS . . . are entitled to great deference,” but this is not a case

17 In December of 2020, the President was quoted as saying, “No I don’t think
[vaccines] should be mandatory.” See, e.g., Jacob Jarvis, Fact Check: Did Joe Biden Reject
Idea of Mandatory Vaccines in December 2020, Newsweek (Sept. 10, 2021),
https://www.newsweek.com/fact-check-joe-biden-no-vaccines-mandatory-december-
2020-1627774.
18 See supra note 13 (Klain endorsement of the term “work-around”).

No. 21-60845
13
where any amount of deference would make a bit of difference. Int’l Chem.
Workers, 830 F.2d at 371.
(d)
We next consider the necessity of the Mandate. The Mandate is
staggeringly overbroad. Applying to 2 out of 3 private-sector employees in
America, in workplaces as diverse as the country itself, the Mandate fails to
consider what is perhaps the most salient fact of all: the ongoing threat of
COVID-19 is more dangerous to some employees than to other employees. All
else equal, a 28 year-old trucker spending the bulk of his workday in the
solitude of his cab is simply less vulnerable to COVID-19 than a 62 year-old
prison janitor. Likewise, a naturally immune unvaccinated worker is
presumably at less risk than an unvaccinated worker who has never had the
virus. The list goes on, but one constant remains—the Mandate fails almost
completely to address, or even respond to, much of this reality and common
sense.
Moreover, earlier in the pandemic, the Agency recognized the
practical impossibility of tailoring an effective ETS in response to COVID-
19. See OSHA D.C. Circuit Brief at 16, 17, 21, 26 (“Based on substantial
evidence, OSHA determined that an ETS is not necessary both because there
are existing OSHA and non-OSHA standards that address COVID-19 and
because an ETS would actually be counterproductive. . . . To address all
employers and to do so with the requisite dispatch, an ETS would at best be
an enshrinement of these general and universally known measures that are
already enforceable through existing OSHA tools that require employers to
assess and address extant hazards. OSHA’s time and resources are better
spent issuing industry-specific guidance that adds real substance and permits
flexibility as we learn more about this virus. Given that we learn more about
COVID-19 every day, setting rules in stone through an ETS (and later a

No. 21-60845
14
permanent rule) may undermine worker protection by permanently
mandating precautions that later prove to be inefficacious. . . . [A]n ETS
could only enshrine broad legal standards that are already in place or direct
employers to develop COVID-19 response plans specific to their businesses,
something employers are already doing. Such a step would be superfluous at
best and could be counterproductive to ongoing state, local, and private
efforts. . . . Additionally, employers may choose any effective method to
abate a recognized hazard under the general duty clause. Contrary to AFL-
CIO’s argument, this flexibility is likely to improve worker safety, because
employers must choose a means of abatement that eliminates the hazard or
materially reduces it to the extent feasible.”). OSHA itself admitted that “an
ETS once issued could very well become ineffective or counterproductive, as
it may be informed by incomplete or ultimately inaccurate information.” Id.
at 30, 32–33 (acknowledging further that “[a]dequate safeguards for workers
could differ substantially based on geographic location, as the pandemic has
had dramatically different impacts on different parts of the country. State and
local requirements and guidance on COVID-19 are thus critical to employers
in determining how to best protect workers, and OSHA must retain flexibility
to adapt its advice regarding incorporation of such local guidance, where
appropriate. . . . [A]n ETS meant to broadly cover all workers with potential
exposure to COVID-19—effectively all workers across the country—would
have to be written at such a general level that it would risk providing very
little assistance at all”).
In light of this immense complexity, one might naturally ask the
Agency—is this situation truly amenable to a one-size-fits-all Mandate? The
likely answer may be why OSHA has in the past “determined that the best
approach for responding to the pandemic is to enforce the existing OSH Act
requirements that address infectious disease hazards, while also issuing
detailed, industry-specific guidance,” which is generally “more effective

No. 21-60845
15
than promulgating a rigid set of requirements for all employers in all
industries based on limited information.” See Sweatt Letter at 2. In sum, as
OSHA itself has previously acknowledged, an ETS appears to be a “poorly-
suited approach for protecting workers against [COVID-19] because no
standard that covers all of the Nation’s workers would protect all those
workers equally.” See id. at 9.
At the same time, the Mandate is also underinclusive. The most
vulnerable worker in America draws no protection from the Mandate if his
company employs 99 workers or fewer. The reason why? Because, as even
OSHA admits, companies of 100 or more employers will be better able to
administer (and sustain) the Mandate. See 86 Fed. Reg. 61,402, 61,403
(“OSHA seeks information about the ability of employers with fewer than
100 employees to implement COVID-19 vaccination and/or testing
programs.”). That may be true. But this kind of thinking belies the premise
that any of this is truly an emergency. Indeed, underinclusiveness of this sort
is often regarded as a telltale sign that the government’s interest in enacting
a liberty-restraining pronouncement is not in fact “compelling.” Cf. Church
of the Lukumi Babalu Aye, Inc. v. City of Hialeah, 508 U.S. 520, 542–46 (1993)
(city’s ban on religious animal sacrifice but corresponding allowance of other
activities similarly endangering public health belied its purportedly
“compelling” interest in safe animal disposal practices). The underinclusive
nature of the Mandate implies that the Mandate’s true purpose is not to
enhance workplace safety, but instead to ramp up vaccine uptake by any
means necessary.19

19 The Mandate is also underinclusive in the solutions it proposes. Indeed, even in
its fullest force, the Mandate cannot prevent vaccinated employees from spreading the
virus in the workplace, or prevent unvaccinated employees from spreading the virus in
between weekly tests.

No. 21-60845
16
(e)

If the deficiencies we’ve already covered aren’t enough, other
miscellaneous considerations seal the Mandate’s fate. For one, “[t]he
Agency cannot use its ETS powers as a stop-gap measure,” Asbestos Info., 727
F.2d at 422, but concedes that that is precisely what the Mandate is intended
to do here. See 86 Fed. Reg. 61,402, 61,434–35 (admitting that “[c]rafting a
multi-layered standard that is comprehensive and feasible for all covered
work settings, including mixed settings of vaccinated and unvaccinated
workers, is an extraordinarily challenging and complicated undertaking, yet
the grave danger that COVID-19 poses to unvaccinated workers obliges the
agency to act as quickly as possible”). For another, courts have consistently
recognized that the “protection afforded to workers [by an ETS] should
outweigh the economic consequences to the regulated industry,” Asbestos
Info., 727 F.2d at 423, but for all the reasons we’ve previously noted, the
Mandate flunks a cost-benefit analysis here.
(f)

It lastly bears noting that the Mandate raises serious constitutional
concerns that either make it more likely that the petitioners will succeed on
the merits, or at least counsel against adopting OSHA’s broad reading of
§ 655(c) as a matter of statutory interpretation.

First, the Mandate likely exceeds the federal government’s authority
under the Commerce Clause because it regulates noneconomic inactivity that
falls squarely within the States’ police power. A person’s choice to remain
unvaccinated and forgo regular testing is noneconomic inactivity. Cf. NFIB
v. Sebelius, 567 U.S. 519, 522 (2012) (Roberts, C.J., concurring); see also id. at
652–53 (Scalia, J., dissenting). And to mandate that a person receive a vaccine
or undergo testing falls squarely within the States’ police power. Zucht v.
King, 260 U.S. 174, 176 (1922) (noting that precedent had long “settled that

No. 21-60845
17
it is within the police power of a state to provide for compulsory
vaccination”); Jacobson v. Massachusetts, 197 U.S. 11, 25–26 (1905) (similar).
The Mandate, however, commandeers U.S. employers to compel millions of
employees to receive a COVID-19 vaccine or bear the burden of weekly
testing. 86 Fed. Reg. 61,402, 61,407, 61,437, 61,552. The Commerce Clause
power may be expansive, but it does not grant Congress the power to regulate
noneconomic inactivity traditionally within the States’ police power. See
Sebelius, 567 U.S. at 554 (Roberts, C.J., concurring) (“People, for reasons of
their own, often fail to do things that would be good for them or good for
society. Those failures—joined with the similar failures of others—can
readily have a substantial effect on interstate commerce. Under the
Government’s logic, that authorizes Congress to use its commerce power to
compel citizens to act as the Government would have them act.”); see also
Bond v. United States, 572 U.S. 844, 854 (2014) (“The States have broad
authority to enact legislation for the public good—what we have often called
B+*'$ +*2 -7C . . . The Federal Government, by contrast, has no such
authority. . . .” (citations omitted)). Indeed, the courts “always have rejected
readings of the Commerce Clause . . . that would permit Congress to exercise
a police power.” United States v. Lopez, 514 U.S. 549, 584 (1995) (Thomas,
J., concurring). In sum, the Mandate would far exceed current constitutional
authority.

Second, concerns over separation of powers principles cast doubt over
the Mandate’s assertion of virtually unlimited power to control individual
conduct under the guise of a workplace regulation. As Judge Duncan points
out, the major questions doctrine confirms that the Mandate exceeds the
bounds of OSHA’s statutory authority. Congress must “speak clearly if it
wishes to assign to an agency decisions of vast economic and political
significance.” Util. Air Regul. Grp. v. EPA, 573 U.S. 302, 324 (2014) (cleaned
up). The Mandate derives its authority from an old statute employed in a

No. 21-60845
18
novel manner,20 imposes nearly $3 billion in compliance costs, involves broad
medical considerations that lie outside of OSHA’s core competencies, and
purports to definitively resolve one of today’s most hotly debated political
issues. Cf. MCI Telecomms. Corp. v. AT&T, 512 U.S. 218, 231 (1994)
(declining to hold that the FCC could eliminate telecommunications rate-
filing requirements); FDA v. Brown & Williamson Tobacco Corp., 529 U.S.
120, 159–60 (2000) (declining to hold that the FDA could regulate
cigarettes); Gonzales v. Oregon, 546 U.S. 243, 262 (2006) (declining to allow
DOJ to ban physician-assisted suicide). There is no clear expression of
congressional intent in § 655(c) to convey OSHA such broad authority, and
this court will not infer one. Nor can the Article II executive breathe new
power into OSHA’s authority—no matter how thin patience wears.

At the very least, even if the statutory language were susceptible to
OSHA’s broad reading—which it is not—these serious constitutional
concerns would counsel this court’s rejection of that reading. Jennings v.
Rodriguez, 138 S. Ct. 830, 836 (2018).
*
*
*
Accordingly, the petitioners’ challenges to the Mandate show a great
likelihood of success on the merits, and this fact weighs critically in favor of
a stay.
B.

It is clear that a denial of the petitioners’ proposed stay would do them
irreparable harm. For one, the Mandate threatens to substantially burden the

20 Here, it is simply unlikely that Congress assigned authority over such a
monumental policy decision to OSHA—hard hats and safety goggles, this is not.

No. 21-60845
19
liberty interests21 of reluctant individual recipients put to a choice between
their job(s) and their jab(s). For the individual petitioners, the loss of
constitutional
freedoms
“for
even
minimal
periods
of
time . . . unquestionably constitutes irreparable injury.” Elrod v. Burns, 427
U.S. 347, 373 (1976) (“The loss of First Amendment freedoms, for even
minimal periods of time, unquestionably constitutes irreparable injury.”).
Likewise, the companies seeking a stay in this case will also be
irreparably harmed in the absence of a stay, whether by the business and
financial effects of a lost or suspended employee, compliance and monitoring
costs associated with the Mandate, the diversion of resources necessitated by
the Mandate, or by OSHA’s plan to impose stiff financial penalties on
companies that refuse to punish or test unwilling employees. The Mandate
places an immediate and irreversible imprint on all covered employers in
America, and “complying with a regulation later held invalid almost always
produces the irreparable harm of nonrecoverable compliance costs.” See
Texas v. EPA, 829 F.3d 405, 433 (5th Cir. 2016) (quoting Thunder Basin Coal
Co. v. Reich, 510 U.S. 200, 220–21 (1994) (Scalia, J., concurring in part and
in the judgment)).
The States, too, have an interest in seeing their constitutionally
reserved police power over public health policy defended from federal
overreach.
C.

In contrast, a stay will do OSHA no harm whatsoever. Any interest
OSHA may claim in enforcing an unlawful (and likely unconstitutional) ETS
is illegitimate. Moreover, any abstract “harm” a stay might cause the Agency

21 Not to mention the free religious exercise of certain employees. See U.S.
Const. amend. I; cf. Holt v. Hobbs, 574 U.S. 352, 361 (2015).

No. 21-60845
20
pales in comparison and importance to the harms the absence of a stay
threatens to cause countless individuals and companies.
D.

For similar reasons, a stay is firmly in the public interest. From
economic uncertainty to workplace strife, the mere specter of the Mandate
has contributed to untold economic upheaval in recent months. Of course,
the principles at stake when it comes to the Mandate are not reducible to
dollars and cents. The public interest is also served by maintaining our
constitutional structure and maintaining the liberty of individuals to make
intensely personal decisions according to their own convictions—even, or
perhaps particularly, when those decisions frustrate government officials.
*
*
*

The Constitution vests a limited legislative power in Congress. For
more than a century, Congress has routinely used this power to delegate
policymaking specifics and technical details to executive agencies charged
with effectuating policy principles Congress lays down. In the mine run of
cases—a transportation department regulating trucking on an interstate
highway, or an aviation agency regulating an airplane lavatory—this is
generally well and good. But health agencies do not make housing policy, and
occupational safety administrations do not make health policy. Cf. Ala. Ass’n
of Realtors, 141 S. Ct. at 2488–90. In seeking to do so here, OSHA runs afoul
of the statute from which it draws its power and, likely, violates the
constitutional structure that safeguards our collective liberty.

For these reasons, the petitioners’ motion for a stay pending review is
GRANTED. Enforcement of the Occupational Safety and Health
Administration’s “COVID-19 Vaccination and Testing; Emergency

No. 21-60845
21
Temporary Standard”22 remains STAYED pending adequate judicial review
of the petitioners’ underlying motions for a permanent injunction.23

In addition, IT IS FURTHER ORDERED that OSHA take no
steps to implement or enforce the Mandate until further court order.

22 86 Fed. Reg. 61,402 (Nov. 5, 2021) (to be codified at 29 C.F.R. pts. 1910, 1915,
1917, 1918, 1926, and 1928).
23 The Clerk of Court shall ensure that this order applies with equal force to all
related motions consolidated into this case in accordance with the court’s November 6,
2021 order.

No. 21-60845
22
Stuart Kyle Duncan, Circuit Judge, concurring:
In addition to the many reasons ably identified by Judge Engelhardt’s
opinion, I underscore one reason why these challenges to OSHA’s
unprecedented mandate are virtually certain to succeed.
Courts “expect Congress to speak clearly when authorizing an agency
/* 3 -$. +*2 -.*!B1./ *)*($)+*'$/$'.$")$!$) 7CEAla. Ass’n
of Realtors v. Dep’t of Health & Human Servs., 141 S. Ct. 2485, 2489 (2021)
(quoting Utility Air Regul. Grp. v. EPA, 573 U.S. 302, 324 (2014)). OSHA’s
rule reaches “two-thirds of all private-sector workers in the nation.”86 Fed.
Reg. 61,402, 61,403 (Nov. 5, 2021). It compels covered employers to (1) make
employees get vaccinated or get weekly tests at their expense and wear
masks; (2) “remove” non-complying employees; (3) pay per-violation fines;
and (4) keep records of employee vaccination or testing status. 86 Fed. Reg.
at 61,402–03, 61,551–54; 29 U.S.C. § 666. OSHA invokes no statute
expressly authorizing the rule. Instead, OSHA issued it under an emergency
provision addressing workplace “substances,” “agents,” or “hazards” that
it has used only ten times in the last 50 years and never to mandate vaccines.
86 Fed. Reg. at 61,403; see 29 U.S.C. § 655(c)(1).
Whether Congress could enact such a sweeping mandate under its
interstate commerce power would pose a hard question. See NFIB v. Sebelius,
567 U.S. 519, 549–61 (2012). Whether OSHA can do so does not.
I concur in granting a stay.

EXHIBIT 3

United States Court of Appeals
for the Fifth Circuit

No. 21-60845

Petitioners,

versus

Occupational Safety and Health Administration,
United States Department of Labor; United States
United States Court of Appeals
Fifth Circuit
FILED
November 6, 2021

Lyle W. Cayce
Clerk

No. 21-60845
2
Department of Labor; Martin J. Walsh, Secretary, U.S.
Department of Labor; Douglas Parker, in his Official
Capacity as Assistant Secretary of Labor for
Occupational Safety and Health,

Respondents.

Petition for Review of
Occupational Safety and Health Administration
Emergency Temporary Standard

Before Jones, Duncan, and Engelhardt, Circuit Judges.
Per Curiam:*
Before the court is the petitioners’1 emergency motion to stay
enforcement of the Occupational Safety and Health Administration’s
November 5, 2021 Emergency Temporary Standard2 (the “Mandate”)
pending expedited judicial review.
Because the petitions give cause to believe there are grave statutory
and constitutional issues with the Mandate, the Mandate is hereby STAYED
pending further action by this court.

* Pursuant to 5th Circuit Rule 47.5, the court has determined that this
opinion should not be published and is not precedent except under the limited
circumstances set forth in 5th Circuit Rule 47.5.4.
1 This order addresses only the emergency motion filed by the above-captioned
petitioners. Going forward, the Clerk of Court shall ensure that all related motions and
petitions in this court be consolidated under this case number, and that all parties—
including the Government—make all related filings in this case.
2 See COVID-19 Vaccination and Testing; Emergency Temporary Standard, 86
Fed. Reg. 61,402 (Nov. 5, 2021) (to be codified at 29 C.F.R. pts. 1910, 1915, 1917, 1918,
1926, and 1928).

No. 21-60845
3
The Government shall respond to the petitioners’ motion for a
permanent injunction by 5:00 PM on Monday, November 8.
The petitioners shall file any reply by 5:00 PM on Tuesday, November
9.

So ordered.

EXHIBIT 4

AFFIDAVIT OF ALFREDO ORTIZ
1.
My name is Alfredo Ortiz. I am over the age of 18 and am competent to make this
declaration. The facts set forth in this declaration are based on my personal
knowledge.
2.
I am the president and CEO of Job Creators Network (“JCN”), a not-for-profit
organization registered under section 501(c)(4) of the Internal Revenue Code.
3.
JCN’s mission is to educate employees of Main Street America, in order to protect
the 85 million people who depend on the success of small businesses. Members join
JCN through its website and receive a weekly newsletter, policy updates,
educational materials, regional and local networking events and media
opportunities that amplify their interests with policymakers and the broader public.
4.
JCN provides its members with the tools to become the voice of free enterprise in
the media, in Congress, in state capitals, in their communities, and their
workplaces – allowing them to hold policymakers and politicians accountable to job
creators and their employees. When JCN members suffer injury due to bad public
policy, JCN amplifies their stories in the media to educate policymakers and the
public about the significant consequences of bad public policy in an attempt to
rectify it.
5.
JCN supports over thirty million small businesses nationwide, many of whom
provide such important public benefits that they were deemed “essential” during
the COVID lockdowns. But after surviving the lockdowns and the height of the
pandemic, these businesses now face substantial, imminent, and irreparable loss
because of the recent OSHA vaccine mandate.
6.
To be clear, JCN is not anti-vaccine. In fact, JCN and many of its members
encourage their employees to get COVID vaccines—but they do not agree with a
government-imposed mandate that will cause incredible injury to businesses,
citizens, and the national economy.
7.
The country—and smaller businesses in particular—is facing a severe labor
shortage, with companies struggling to hire enough workers to keep up with
demand. The strain is even more severe for companies that require workers to have
certain licenses or training, which makes the pool of applicants even smaller.
8.
If any sizable number of unvaccinated employees quit rather than subject
themselves to involuntary vaccination or weekly testing, those companies will
necessarily lose work, damage their reputations, and face a distinct possibility of
shutting down.
9.
And it is not mere conjecture that workers will leave companies rather than comply.
Given the labor shortage, it is easy for those employees to leave a company with 100

or more employees (covered by the mandate) and go to a smaller company (not
covered by the mandate). In fact, even before any deadlines in the mandate take
legal effect, workers will leave for new jobs in order to maximize their future
employment opportunities.
10.
On top of the labor issues caused by the mandate, there will be dramatic compliance
costs: JCN members will have to stand up systems to track their vaccinated
employees and weekly testing of unvaccinated employees. Any oversight or mistake
during this process could lead to fines of nearly $14,000. Further, companies have
been left in the dark about whether they will have to pay for the tracking system
and frequent testing, which tests are acceptable, whether costs can or should be
passed along to employees, and whether the companies will be liable if an employee
suffers an adverse effect from the vaccine.
11.
JCN members like Lawrence Trucking Company and Guy Chemical—whose leaders
are submitting their own affidavits in this matter—provide confirmation of the
incredible damage the mandate will cause to smaller businesses regulated by the
mandate. They are merely the tip of the iceberg, as the mandate will allegedly apply
to 100 million workers across the country, regardless of industry.
12.
On October 19, 2021, I participated in a call with representatives from OSHA,
Office of Information and Regulatory Affairs and the Small Business
Administration to try and persuade them not to issue the mandate, or to narrow its
scope dramatically. But these agencies said they were not allowed to reveal
anything about the scope of the mandate until it was issued publicly. The lack of
transparency and public involvement and scrutiny in formulating the mandate has
provided its own harms because JCN members have no idea what would be included
in the mandate, what exceptions might apply, or even whether they will actually be
covered by it.
13.
I declare under penalty of perjury that the foregoing is true and correct.
Executed on: October 21, 2021
___________________________

Alfredo Ortiz

AFFIDAVIT OF GARY RABINE
My name is Gary Rabine. I am over the age of 18 and am competent to make this
declaration. The facts set forth in this declaration are based on my personal
knowledge.
I am the founder and chairman of the Rabine Group of Companies, whichincludes
over a dozen separate entities in Illinois, totaling over 300 employees. I amalso a
cofounder and shareholder of Pipe View America where we have over 100
employees. Our companies specialize in repairing parking lots, roofs, doors and
commercial docks, and HVAC systems, as well as in snow removal.
Because of our employee totals, we are subject to the new OSHA emergency
vaccine mandate, which requires employees to receive a coronavirus vaccine or get
tested frequently, with noncompliance resulting in major fines.
The new OSHA vaccine mandate causes irreparable and imminent harm to the
Rabine Group and each of its companies. We are already facing severe labor
shortages and are struggling to find enough workers to keep up with our customers’
needs.
Many of our employees must have specialized training and knowledge about
industry safety, machinery and repair processes—knowledge that cannot be learned
quickly. For all of these reasons, our companies face a limited pool of potential hires
to fill any vacancies, and new hires cannot become immediately operational.
Based on my own personal knowledge, I estimate that approximately 20% of our
employees would refuse to comply with the mandate. If forced to comply, some of
them would find jobs with smaller companies not covered (yet) by a federal vaccine
mandate, but others would be left jobless. Many of our employees have been with us
for decades and are like family. They are not job hoppers who know how to move
from one job to the next.
If 20% of our workers cannot show up, we would no longer be a profitable
enterprise. This is especially true because the employees we’d lose are among our
leadership team and often the hardest working: people who love freedom and have
strong independent minds become our greatest leaders and get the job done. These
employees would be unable to provide for their families, pay bills, or even spend
money on necessities—causing a cascading loss of wealth and economic activity in
the smaller towns where many of our employees live. The loss of these people will
cause a downsizing that will cause additional teammates, whether vaccinated or
not, to be laid off.
If this happens, we would undoubtedly lose substantial business and clients to
other companies because customers’ repair work needs to be done as soon as
possible. They cannot wait weeks or months for us to recruit and train more

employees. We would suffer tremendous financial and reputational damages from
not being able to show up quickly to emergency jobs.
9. There would also be terrible consequences for the public. People depend on our
companies to arrive within hours, if not minutes, to repair failing roofs, parking lots
with sink holes and pot holes, failing HVAC systems on cold days, and broken
ramps, docks, and doors that prevent buildings from being operational. These
customers can face legal liability if they do not get repairs finished quickly. We
provide those services—but we will be unable to meet demand because of the
vaccine mandate.
10. Because of the critical services we provide, all of our construction services
companies in the Rabine Group of Companies were deemed “essential” during the
lockdowns.
11. After everything our companies—and other small businesses just like them—
have been through in the last two years, it is unthinkable that the federal
government would impose this mandate. It is a catastrophic job killer and an
offensive and financially devastating violation of liberty.
12. I declare under penalty of perjury that the foregoing is true and correct.
Executed on: October ______, 2021
_______________________
Gary Rabine
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EXHIBIT 5

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EXHIBIT 6

61402
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
29 CFR Parts 1910, 1915, 1917, 1918,
1926, and 1928
[Docket No. OSHA–2021–0007]
RIN 1218–AD42
COVID–19 Vaccination and Testing;
Emergency Temporary Standard
AGENCY: Occupational Safety and Health
Administration (OSHA), Department of
Labor.
ACTION: Interim final rule; request for
comments.
SUMMARY: The Occupational Safety and
Health Administration (OSHA) is
issuing an emergency temporary
standard (ETS) to protect unvaccinated
employees of large employers (100 or
more employees) from the risk of
contracting COVID–19 by strongly
encouraging vaccination. Covered
employers must develop, implement,
and enforce a mandatory COVID–19
vaccination policy, with an exception
for employers that instead adopt a
policy requiring employees to either get
vaccinated or elect to undergo regular
COVID–19 testing and wear a face
covering at work in lieu of vaccination.
DATES: The rule is effective November 5,
2021. The incorporation by reference of
certain publications listed in the rule is
approved by the Director of the Federal
Register as of November 5, 2021.
Compliance dates: Compliance dates
for specific provisions are in 29 CFR
1910.501(m).
Comments: Written comments,
including comments on any aspect of
this ETS and whether this ETS should
become a final rule, must be submitted
by December 6, 2021 in Docket No.
OSHA–2021–0007. Comments on the
information collection determination
described in Additional Requirements
(Section V.K. of this preamble) (OMB
review under the Paperwork Reduction
Act of 1995) may be submitted by
January 4, 2022 in Docket No. OSHA–
2021–0008.
ADDRESSES: In accordance with 28
U.S.C. 2112(a), the Agency designates
Edmund C. Baird, the Associate
Solicitor for Occupational Safety and
Health, Office of the Solicitor, U.S.
Department of Labor, to receive
petitions for review of the ETS. Service
can be accomplished by email to zzSOL-
Covid19-ETS@dol.gov.
Written comments. You may submit
comments and attachments, identified
by Docket No. OSHA–2021–0007,
electronically at www.regulations.gov,
which is the Federal e-Rulemaking
Portal. Follow the online instructions
for making electronic submissions.
Instructions: All submissions must
include the agency’s name and the
docket number for this rulemaking
(Docket No. OSHA–2021–0007). All
comments, including any personal
information you provide, are placed in
the public docket without change and
may be made available online at
www.regulations.gov. Therefore, OSHA
cautions commenters about submitting
information they do not want made
available to the public, or submitting
materials that contain personal
information (either about themselves or
others), such as Social Security
Numbers and birthdates.
Docket: To read or download
comments or other material in the
docket, go to Docket No. OSHA–2021–
0007 at www.regulations.gov. All
comments and submissions are listed in
the www.regulations.gov index;
however, some information (e.g.,
copyrighted material) is not publicly
available to read or download through
that website. All comments and
submissions, including copyrighted
material, are available for inspection
through the OSHA Docket Office.
Documents submitted to the docket by
OSHA or stakeholders are assigned
document identification numbers
(Document ID) for easy identification
and retrieval. The full Document ID is
the docket number plus a unique four-
digit code. OSHA is identifying
supporting information in this ETS by
author name and publication year, when
appropriate. This information can be
used to search for a supporting
document in the docket at http://
www.regulations.gov. Contact the OSHA
Docket Office at 202–693–2350 (TTY
number: 877–889–5627) for assistance
in locating docket submissions.
FOR FURTHER INFORMATION CONTACT:
General information and press
inquiries: Contact Frank Meilinger,
OSHA Office of Communications, U.S.
Department of Labor; telephone (202)
693–1999; email OSHAComms@dol.gov.
For technical inquiries: Contact
Andrew Levinson, OSHA Directorate of
Standards and Guidance, U.S.
Department of Labor; telephone (202)
693–1950; email ETS@dol.gov.
SUPPLEMENTARY INFORMATION: The
preamble to the ETS on COVID–19
vaccination and testing follows this
outline:
Table of Contents
I. Executive Summary and Request for
Comment
A. Executive Summary
B. Request for Comment
II. Pertinent Legal Authority
III. Rationale for the ETS
A. Grave Danger
B. Need for the ETS
IV. Feasibility
A. Technological Feasibility
B. Economic Analysis
V. Additional Requirements
VI. Summary and Explanation
A. Purpose
B. Scope and Application
C. Definitions
D. Employer Policy on Vaccination
E. Determination of Employee Vaccination
Status
F. Employer Support for Employee
Vaccination
G. COVID–19 Testing for Employees Who
Are Not Fully Vaccinated
H. Employee Notification to Employer of a
Positive COVID–19 Test and Removal
I. Face Coverings
J. Information Provided to Employees
K. Reporting COVID–19 Fatalities and
Hospitalizations to OSHA
L. Availability of Records
M. Dates
N. Severability
O. Incorporation by Reference
VII. Authority and Signature
I. Executive Summary and Request for
Comment
A. Executive Summary
This ETS is based on the requirements
of the Occupational Safety and Health
Act (OSH Act or Act) and legal
precedent arising under the Act. Under
section 6(c)(1) of the OSH Act, 29 U.S.C.
655(c)(1), OSHA shall issue an ETS if
the agency determines that employees
are subject to grave danger from
exposure to substances or agents
determined to be toxic or physically
harmful or from new hazards, and an
ETS is necessary to protect employees
from such danger. These legal
requirements are more fully discussed
in Pertinent Legal Authority (Section II.
of this preamble). This ETS does not
apply to workplaces subject to E.O.
14042 on Requiring Coronavirus Disease
2019 Vaccination for Federal
Contractors. In addition, OSHA will
treat federal agencies’ compliance with
E.O. 14043, and the Safer Federal
Workforce Task Force guidance issued
under section 4(e) of Executive Order
13991 and section 2 of Executive Order
14043, as sufficient to meet their
obligations under the OSH Act and E.O.
12196.
COVID–19 has killed over 725,000
people in the United States in less than
two years, and infected millions more
(CDC, October 18, 2021—Cumulative
US Deaths). The pandemic continues to
affect workers and workplaces. While
COVID–19 vaccines authorized or
VerDate Sep<11>2014
22:27 Nov 04, 2021
Jkt 256001
PO 00000
Frm 00002
Fmt 4701
Sfmt 4700
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05NOR2
jspears on DSK121TN23PROD with RULES2

61403
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
approved by the U.S. Food and Drug
Administration (FDA) effectively protect
vaccinated individuals against severe
illness and death from COVID–19,
unvaccinated individuals remain at
much higher risk of severe health
outcomes from COVID–19. Further,
unvaccinated workers are much more
likely to contract and transmit COVID–
19 in the workplace than vaccinated
workers. OSHA has determined that
many employees in the U.S. who are not
fully vaccinated against COVID–19 face
grave danger from exposure to SARS–
CoV–2 in the workplace. This finding of
grave danger is based on the severe
health consequences associated with
exposure to the virus along with
evidence demonstrating the
transmissibility of the virus in the
workplace and the prevalence of
infections in employee populations, as
discussed in Grave Danger (Section
III.A. of this preamble).
OSHA has also determined that an
ETS is necessary to protect
unvaccinated workers from the risk of
contracting COVID–19 at work, as
discussed in Need for the ETS (Section
III.B. of this preamble). At the present
time, workers are becoming seriously ill
and dying as a result of occupational
exposures to COVID–19, when a simple
measure, vaccination, can largely
prevent those deaths and illnesses. The
ETS protects these workers through the
most effective and efficient control
available—vaccination—and further
protects workers who remain
unvaccinated through required regular
testing, use of face coverings, and
removal of all infected employees from
the workplace. OSHA also concludes,
based on its enforcement experience
during the pandemic to date, that
continued reliance on existing standards
and regulations, the General Duty
Clause of the OSH Act, 29 U.S.C.
654(a)(1), and workplace guidance, in
lieu of an ETS, is not adequate to protect
unvaccinated employees from the grave
danger of being infected by, and
suffering death or serious health
consequences from, COVID–19.
OSHA will continue to monitor trends
in COVID–19 infections and death as
more of the workforce and the general
population become fully vaccinated
against COVID–19 and the pandemic
continues to evolve. Where OSHA finds
a grave danger from the virus no longer
exists for the covered workforce (or
some portion thereof), or new
information indicates a change in
measures necessary to address the grave
danger, OSHA will update this ETS, as
appropriate.
This ETS applies to employers with a
total of 100 or more employees at any
time the standard is in effect. In light of
the unique occupational safety and
health dangers presented by COVID–19,
and against the backdrop of the
uncertain economic environment of a
pandemic, OSHA is proceeding in a
stepwise fashion in addressing the
emergency this rule covers. OSHA is
confident that employers with 100 or
more employees have the administrative
capacity to implement the standard’s
requirements promptly, but is less
confident that smaller employers can do
so without undue disruption. OSHA
needs additional time to assess the
capacity of smaller employers, and is
seeking comment to help the agency
make that determination. Nonetheless,
the agency is acting to protect workers
now in adopting a standard that will
reach two-thirds of all private-sector
workers in the nation, including those
working in the largest facilities, where
the most deadly outbreaks of COVID–19
can occur.
The agency has also evaluated the
feasibility of this ETS and has
determined that the requirements of the
ETS are both economically and
technologically feasible, as outlined in
Feasibility (Section IV. of this
preamble). The specific requirements of
the ETS are outlined and described in
Summary and Explanation (Section VI.
of this preamble).
B. Request for Comment
Although this ETS takes effect
immediately, it also serves as a proposal
under Section 6(b) of the OSH Act (29
U.S.C. 655(b)) for a final standard.
Accordingly, OSHA seeks comment on
all aspects of this ETS and whether it
should be adopted as a final standard.
OSHA encourages commenters to
explain why they prefer or disfavor
particular policy choices, and include
any relevant studies, experiences,
anecdotes or other information that may
help support the comment. In
particular, OSHA seeks comments on
the following topics:
1. Employers with fewer than 100
employees. As noted above and fully
discussed in the Summary and
Explanation for Scope and Application
(Section VI.B. of this preamble), OSHA
has implemented a 100-employee
threshold for the requirements of this
standard to focus the ETS on companies
that OSHA is confident will have
sufficient administrative systems in
place to comply quickly with the ETS.
The agency is moving in a stepwise
fashion on the short timeline
necessitated by the danger presented by
COVID–19 while soliciting stakeholder
comment and additional information to
determine whether to adjust the scope
of the ETS to address smaller employers
in the future. OSHA seeks information
about the ability of employers with
fewer than 100 employees to implement
COVID–19 vaccination and/or testing
programs. Have you instituted
vaccination mandates (with or without
alternatives), or requirements for regular
COVID–19 testing or face covering use?
What have been the benefits of your
approach? What challenges have you
had or could you foresee in
implementing such programs? Is there
anything specific to your industry, or
the size of your business, that poses
particular obstacles in implementing the
requirements in this standard? How
much time would it take, what types of
costs would you incur, and how much
would it cost for you to implement such
requirements?
2. Significant Risk. If OSHA were to
finalize a rule based on this ETS, it
would be a standard adopted under 6(b)
of the OSH Act, which requires a
finding of significant risk from exposure
to COVID–19. As discussed more fully
in Pertinent Legal Authority (Section II.
of this preamble), this is a lower
showing of risk than grave danger, the
finding required to issue a 6(c)
emergency temporary standard. How
should the scope of the rule change to
address the significant risk posed by
COVID–19 in the workplace? Should
portions of the rule, such as face
coverings, apply to fully vaccinated
persons?
3. Prior COVID–19 infections. OSHA
determined that workers who have been
infected with COVID–19 but have not
been fully vaccinated still face a grave
danger from workplace exposure to
SARS–CoV–2. This is an area of ongoing
scientific inquiry. Given scientific
uncertainty and limitations in testing for
infection and immunity, OSHA is
concerned that it would be infeasible for
employers to operationalize a standard
that would permit or require an
exception from vaccination or testing
and face covering based on prior
infection with COVID–19. Is there
additional scientific information on this
topic that OSHA should consider as it
determines whether to proceed with a
permanent rule?
In particular, what scientific criteria
can be used to determine whether a
given employee is sufficiently protected
against reinfection? Are there any
temporal limits associated with this
criteria to account for potential
reductions in immunity over time? Do
you require employees to provide
verification of infection with COVID–
19? If so, what kinds of verification do
you accept (i.e., PCR testing, antigen
testing, etc.)? What challenges have you
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1 The Secretary has delegated most of his duties
under the OSH Act to the Assistant Secretary of
Labor for Occupational Safety and Health.
Secretary’s Order 08–2020, 85 FR 58393 (Sept. 18,
2020). This section uses the terms Secretary and
OSHA interchangeably.
experienced, if any, in operationalizing
such an exception?
4. Experience with COVID–19
vaccination policies. Should OSHA
impose a strict vaccination mandate
(i.e., all employers required to
implement mandatory vaccination
policies as defined in this ETS) with no
alternative compliance option? OSHA
seeks information on COVID–19
vaccination policies that employers
have implemented to protect workers. If
you have implemented a COVID–19
vaccination policy:
(a) When did you implement it, and
what does your policy require? Was
vaccination mandatory or voluntary
under the policy? Do you offer
vaccinations on site? What costs
associated with vaccination did you
cover under the policy? What
percentage of your workforce was
vaccinated as a result? Do you offer paid
leave for receiving a vaccination? If
vaccination is mandatory, have
employees been resistant and if so what
steps were required to enforce the
policy?
(b) How did you verify that employees
were vaccinated? Are there other
reliable means of vaccination
verification not addressed by the ETS
that should be included? Did you allow
attestation where the employee could
not find other proof, and if so, have you
experienced any difficulties with this
approach? Have you experienced any
issues with falsified records of
vaccination, and if so, how did you deal
with them?
(c) Have you experienced a decrease
in infection rates or outbreaks after
implementing this policy?
(d) If you have received any requests
for reasonable accommodation from
vaccination, what strategies did you
implement to address the
accommodation and ensure worker
safety (e.g., telework, working in
isolation, regular testing and the use of
face coverings)?
5. COVID–19 testing and removal.
OSHA seeks information on COVID–19
testing and removal practices
implemented to protect workers.
(a) Do you have a testing and removal
policy in your workplace and, if so,
what does it require? How often do you
require testing and what types of testing
do you use (e.g., at-home tests, tests
performed at laboratories, tests
performed at your worksites)? What
costs have you incurred as part of your
testing and removal policies? Do you
have difficulty in finding adequate
availability of tests? How often? Have
you experienced any issues with
falsified test results, and if so, how did
you deal with them? Have you
experienced other difficulties in
implementing a testing and removal
scheme, including the length of time to
obtain COVID–19 test results? Do you
offer paid leave for testing?
(b) How often have you detected and
removed COVID–19 positive employees
from the workplace under this policy?
Do you provide paid leave and job
protection to employees you remove for
this reason?
(c) Should OSHA require testing more
often than on a weekly basis?
6. Face coverings. As discussed in the
Summary and Explanation for Face
Coverings (Section VI.I. of this
preamble), ASTM released a
specification standard on February 15,
2021, to establish a national standard
baseline for barrier face coverings
(ASTM F3502–21). Should OSHA
require the use of face coverings
meeting the ASTM F3502–21 standard
instead of the face coverings specified
by the ETS? If so, should OSHA also
require that such face coverings meet
the NIOSH Workplace Performance or
Workplace Performance Plus criteria
(see CDC, September 23, 2021)? Are
there particular workplace settings in
which face coverings meeting one
standard should be favored over
another? Are there alternative criteria
OSHA should consider for face
coverings instead of the F3502–21
standard or NIOSH Workplace
Performance or Workplace Performance
Plus criteria? Is there sufficient capacity
to supply face coverings meeting
F3502–01 and/or NIOSH Workplace
Performance or Workplace Performance
Plus criteria to all employees covered by
the ETS? What costs have you incurred
as part of supplying employees with
face coverings meeting the appropriate
criteria?
7. Other controls. This ETS requires
employees to either be fully vaccinated
against COVID–19 or be tested weekly
and wear face coverings, based on the
type of policy their employer adopts. It
stops short of requiring the full suite of
workplace controls against SARS–CoV–
2 transmission recommended by OSHA
and the CDC, including distancing,
barriers, ventilation, and sanitation. As
OSHA explained in Need for the ETS
(Section III.B. of this preamble), OSHA
has determined that it needs more
information before imposing these
requirements on the entire scope of
industries and employers covered by the
standard. OSHA is interested in hearing
from employers about their experience
in implementing a full suite of
workplace controls against COVID–19.
What measures have you taken to
protect employees against COVID–19 in
your workplace? Are there controls that
you attempted to employ but found
ineffective or infeasible? What are they?
Why did you conclude that they were
they ineffective or infeasible; for
example, are there particular aspects of
your workplace or industry that make
certain controls infeasible? Do you
require both fully vaccinated and
unvaccinated employees to comply with
these controls? Have you experienced a
reduction in infection rates or outbreaks
since implementing these controls?
8. Educational materials. Have you
implemented any policies or provided
any information that has been helpful in
encouraging an employee to be
vaccinated?
9. Feasibility and health impacts. Do
you have any experience or data that
would inform OSHA’s estimates in its
economic feasibility analysis or any of
the assumptions or estimates used in
OSHA’s identification of the number of
hospitalizations prevented and lives
saved from its health impacts analysis
(see OSHA, October 2021c)?
References
Centers for Disease Control and Prevention
(CDC). (2021, October 18). COVID Data
Tracker. https://covid.cdc.gov/covid-
data-tracker/. (CDC, October 18, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, September 23). Types of
Masks and Respirators. https://
www.cdc.gov/coronavirus/2019-ncov/
prevent-getting-sick/types-of-masks.html.
(CDC, September 23, 2021)
Occupational Safety and Health
Administration (OSHA). (2021c,
October). Health Impacts of the COVID–
19 Vaccination and Testing ETS. (OSHA,
October 2021c)
II. Pertinent Legal Authority
The purpose of the Occupational
Safety and Health Act of 1970 (OSH
Act), 29 U.S.C. 651 et seq., is ‘‘to assure
so far as possible every working man
and woman in the Nation safe and
healthful working conditions and to
preserve our human resources.’’ 29
U.S.C. 651(b). To this end, Congress
authorized the Secretary of Labor
(Secretary) to promulgate and enforce
occupational safety and health
standards under sections 6(b) and (c) of
the OSH Act.1 29 U.S.C. 655(b). These
provisions provide bases for issuing
occupational safety and health
standards under the Act. Once OSHA
has established as a threshold matter
that a health standard is necessary
under section 6(b) or (c)—i.e., to reduce
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a significant risk of material health
impairment, or a grave danger to
employee health—the Act gives the
Secretary ‘‘almost unlimited discretion
to devise means to achieve the
congressionally mandated goal’’ of
protecting employee health, subject to
the constraints of feasibility. See United
Steelworkers of Am. v. Marshall, 647
F.2d 1189, 1230 (D.C. Cir. 1981). A
standard’s individual requirements need
only be ‘‘reasonably related’’ to the
purpose of ensuring a safe and healthful
working environment. Id. at 1237, 1241;
see also Forging Indus. Ass’n v. Sec’y of
Labor, 773 F.2d 1436, 1447 (4th Cir.
1985). OSHA’s authority to regulate
employers is hedged by constitutional
considerations and, pursuant to section
4(b)(1) of the OSH Act, the regulations
and enforcement policies of other
federal agencies. See, e.g., Chao v.
Mallard Bay Drilling, Inc., 534 U.S. 235,
241 (2002).
The OSH Act in section 6(c)(1) states
that the Secretary ‘‘shall’’ issue an
emergency temporary standard (ETS)
upon a finding that the ETS is necessary
to address a grave danger to workers.
See 29 U.S.C. 655(c). In particular, the
Secretary shall provide, without regard
to the requirements of chapter 5, title 5,
United States Code, for an emergency
temporary standard to take immediate
effect upon publication in the Federal
Register if the Secretary makes two
determinations: That employees are
exposed to grave danger from exposure
to substances or agents determined to be
toxic or physically harmful or from new
hazards, and that such emergency
standard is necessary to protect
employees from such danger. 29 U.S.C.
655(c)(1). A separate section of the OSH
Act, section 8(c), authorizes the
Secretary to prescribe regulations
requiring employers to make, keep, and
preserve records that are necessary or
appropriate for the enforcement of the
Act. 29 U.S.C. 657(c)(1). Section 8(c)
also provides that the Secretary shall
require employers to keep records of,
and report, work-related deaths and
illnesses. 29 U.S.C. 657(c)(2).
The ETS provision, section 6(c)(1),
exempts the Secretary from procedural
requirements contained in the OSH Act
and the Administrative Procedure Act,
including those for public notice,
comments, and a rulemaking hearing.
See, e.g., 29 U.S.C. 655(b)(3); 5 U.S.C.
552, 553.
The Secretary must issue an ETS in
situations where employees are exposed
to a ‘‘grave danger’’ and immediate
action is necessary to protect those
employees from such danger. 29 U.S.C.
655(c)(1); Pub. Citizen Health Research
Grp. v. Auchter, 702 F.2d 1150, 1156
(D.C. Cir. 1983). The determination of
what exact level of risk constitutes a
‘‘grave danger’’ is a ‘‘policy
consideration that belongs, in the first
instance, to the Agency.’’ Asbestos Info.
Ass’n, 727 F.2d at 425 (accepting
OSHA’s determination that eighty lives
at risk over six months was a grave
danger); Indus. Union Dep’t, AFL–CIO v.
Am. Petroleum Inst., 448 U.S. 607, 655
n.62 (1980). However, a ‘‘grave danger’’
represents a risk greater than the
‘‘significant risk’’ that OSHA must show
in order to promulgate a permanent
standard under section 6(b) of the OSH
Act, 29 U.S.C. 655(b). Int’l Union,
United Auto., Aerospace, & Agr.
Implement Workers of Am., UAW v.
Donovan, 590 F. Supp. 747, 755–56
(D.D.C. 1984), adopted, 756 F.2d 162
(D.C. Cir. 1985); see also Indus. Union
Dep’t, AFL–CIO, 448 U.S. at 640 n.45
(noting the distinction between the
standard for risk findings in permanent
standards and ETSs).
In determining the type of health
effects that may constitute a ‘‘grave
danger’’ under the OSH Act, the Fifth
Circuit emphasized ‘‘the danger of
incurable, permanent, or fatal
consequences to workers, as opposed to
easily curable and fleeting effects on
their health.’’ Fla. Peach Growers Ass’n,
Inc. v. U. S. Dep’t of Labor, 489 F.2d
120, 132 (5th Cir. 1974). Although the
findings of grave danger and necessity
must be based on evidence of ‘‘actual,
prevailing industrial conditions,’’ see
Int’l Union, 590 F. Supp. at 751, when
OSHA determines that exposure to a
particular hazard would pose a grave
danger to workers, OSHA can assume an
exposure to a grave danger wherever
that hazard is present in a workplace.
Dry Color Mfrs. Ass’n, Inc. v. Dep’t of
Labor, 486 F.2d 98, 102 n.3 (3d Cir.
1973).
In demonstrating whether OSHA had
shown that an ETS is necessary, the
Fifth Circuit considered whether OSHA
had another available means of
addressing the risk that would not
require an ETS. Asbestos Info. Ass’n,
727 F.2d at 426 (holding that necessity
had not been proven where OSHA could
have increased enforcement of already-
existing standards to address the grave
risk to workers from asbestos exposure).
Additionally, a standard must be both
economically and technologically
feasible in order to be ‘‘reasonably
necessary and appropriate’’ under
section 3(8) and, by inference,
‘‘necessary’’ under section 6(c)(1)(B) of
the Act. Cf. Am. Textile Mfrs. Inst., Inc.
v. Donovan, 452 U.S. 490, 513 n.31
(1981) (noting ‘‘any standard that was
not economically or technologically
feasible would a fortiori not be
‘reasonably necessary or appropriate’ ’’
as required by the OSH Act’s definition
of ‘‘occupational safety and health
standard’’ in section 3(8)); see also
Florida Peach Growers, 489 F.2d at 130
(recognizing that the promulgation of
any standard, including an ETS, must
account for its economic effect).
However, given that section 6(c) is
aimed at enabling OSHA to protect
workers in emergency situations, the
agency is not required to make a
feasibility showing with the same rigor
as in ordinary section 6(b) rulemaking.
Asbestos Info. Ass’n, 727 F.2d at 424
n.18.
On judicial review of an ETS, OSHA
is entitled to great deference on the
determinations of grave danger and
necessity required under section 6(c)(1).
See, e.g., Pub. Citizen Health Research
Grp., 702 F.2d at 1156; Asbestos Info.
Ass’n, 727 F.2d at 422 (judicial review
of these legislative determinations
requires deference to the agency); cf.
Am. Dental Ass’n v. Martin, 984 F.2d
823, 831 (7th Cir. 1993) (‘‘the duty of a
reviewing court of generalist judges is
merely to patrol the boundary of
reasonableness’’). These determinations
are ‘‘essentially legislative and rooted in
inferences from complex scientific and
factual data.’’ Pub. Citizen Health
Research Grp., 702 F.2d at 1156. The
agency is not required to support its
conclusions ‘‘with anything
approaching scientific certainty,’’ Indus.
Union Dep’t, AFL–CIO, 448 U.S. at 656,
and has the ‘‘prerogative to choose
between conflicting evidence.’’ Asbestos
Info. Ass’n, 727 F.2d at 425.
The determinations of the Secretary in
issuing standards under section 6 of the
OSH Act, including ETSs, must be
affirmed if supported by ‘‘substantial
evidence in the record considered as a
whole.’’ 29 U.S.C. 655(f). The Supreme
Court described substantial evidence as
‘‘such relevant evidence as a reasonable
mind might accept as adequate to
support a conclusion.’’ Am. Textile
Mfrs. Inst., 452 U.S. at 522–23 (quoting
Universal Camera Corp. v. NLRB, 340
U.S. 474, 477 (1951)). The Court also
noted that ‘‘the possibility of drawing
two inconsistent conclusions from the
evidence does not prevent an
administrative agency’s finding from
being supported by substantial
evidence.’’ Id. at 523 (quoting Consolo
v. FMC, 383 U.S. 607, 620 (1966)). The
Fifth Circuit, recognizing the size and
complexity of the rulemaking record
before it in the case of OSHA’s ETS for
organophosphorus pesticides, stated
that a court’s function in reviewing an
ETS to determine whether it meets the
substantial evidence standard is
‘‘basically [to] determine whether the
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Secretary carried out his essentially
legislative task in a manner reasonable
under the state of the record before
him.’’ Fla Peach Growers Ass’n, 489
F.2d at 129.
Although Congress waived the
ordinary rulemaking procedures in the
interest of ‘‘permitting rapid action to
meet emergencies,’’ section 6(e) of the
OSH Act, 29 U.S.C. 655(e), requires
OSHA to include a statement of reasons
for its action when it issues any
standard. Dry Color Mfrs., 486 F.2d at
105–06 (finding OSHA’s statement of
reasons inadequate). By requiring the
agency to articulate its reasons for
issuing an ETS, the requirement acts as
‘‘an essential safeguard to emergency
temporary standard-setting.’’ Id. at 106.
However, the Third Circuit noted that it
did not require justification of ‘‘every
substance, type of use or production
technique,’’ but rather a ‘‘general
explanation’’ of why the standard is
necessary. Id. at 107.
ETSs are, by design, temporary in
nature. Under section 6(c)(3), an ETS
serves as a proposal for a permanent
standard in accordance with section 6(b)
of the OSH Act (permanent standards),
and the Act calls for the permanent
standard to be finalized within six
months after publication of the ETS. 29
U.S.C. 655(c)(3); see Fla. Peach Growers
Ass’n, 489 F.2d at 124. The ETS is
effective ‘‘until superseded by a
standard promulgated in accordance
with’’ section 6(c)(3). 29 U.S.C.
655(c)(2).
Section 6(c)(1) states that the
Secretary ‘‘shall’’ provide for an ETS
when OSHA makes the prerequisite
findings of grave danger and necessity.
See Pub. Citizen Health Research Grp.,
702 F.2d at 1156 (noting the mandatory
language of section 6(c)). OSHA is
entitled to great deference in its
determinations, and it must also
account for ‘‘the fact that ‘the interests
at stake are not merely economic
interests in a license or a rate structure,
but personal interests in life and
health.’ ’’ Id. (quoting Wellford v.
Ruckelshaus, 439 F.2d 598, 601 (D.C.
Cir. 1971)).
When OSHA issues a standard
pursuant to section 6—whether
permanent or an ETS—section 18 of the
OSH Act provides that OSHA’s standard
preempts any state occupational safety
or health standard ‘‘relating to [the
same] occupational safety or health
issue’’ as the Federal standard. 29 U.S.C.
667(b); see also Gade v. Nat’l Solid
Wastes Mgmt. Ass’n, 505 U.S. 88, 97
(1992). A state can avoid preemption
only if it submits, and receives Federal
approval for, a state plan for the
development and enforcement of
standards pursuant to section 18 of the
Act, which must be ‘‘at least as
effective’’ as the Federal standards. 29
U.S.C. 667; Indus. Truck Ass’n v. Henry,
125 F.3d 1305, 1311 (9th Cir. 1997).
However, the OSH Act does not
preempt state laws of ‘‘general
applicability’’ that regulate workers and
non-workers alike, so long as they do
not conflict with an OSHA standard.
Gade, 505 U.S. at 107.
As discussed in detail elsewhere in
this preamble, OSHA has determined
that a grave danger exists necessitating
a new ETS (see Grave Danger and Need
for the ETS, Sections III.A. and III.B. of
this preamble), and that compliance
with this ETS is feasible for covered
employers (see Feasibility, Section IV. of
this preamble). OSHA has also provided
a more detailed explanation of each
provision of this ETS in Summary and
Explanation (Section VI. of this
preamble). In addition, OSHA wishes to
provide here some general guidance on
its legal authority to regulate COVID–19
hazards, and for particular provisions of
this ETS.
As a threshold matter, OSHA’s
authority to regulate workplace
exposure to biological hazards like
SARS–CoV–2 is well-established.
Section 6(b)(5) of the OSH Act uses
similar language to section 6(c)(1)(A):
The former sets forth requirements for
promulgating permanent standards
addressing ‘‘toxic materials or harmful
physical agents,’’ and the latter
authorizes OSHA to promulgate an ETS
addressing ‘‘substances or agents
determined to be toxic or physically
harmful’’ (as well as ‘‘new hazards’’).
OSHA has consistently identified
biological hazards similar to SARS–
CoV–2, as well as SARS–CoV–2 itself, to
be ‘‘toxic materials or harmful physical
agents’’ under the Act. Indeed, in its
exposure and medical records access
regulation, OSHA has defined ‘‘toxic
materials or harmful physical agents’’ to
include ‘‘any . . . biological agent
(bacteria, virus, fungus, etc.)’’ for which
there is evidence that it poses a chronic
or acute health hazard. 29 CFR
1910.1020(c)(13). And in addition to
previously regulating exposure to
SARS–CoV–2 as a new and physically
harmful agent in the Healthcare ETS
(see, e.g., 86 FR at 32381), OSHA has
also previously regulated biological
hazards like SARS–CoV–2 as health
hazards under section 6(b)(5), for
example in the Bloodborne Pathogens
(BBP) standard, 29 CFR 1910.1030,
which addresses workplace exposure to
HIV and Hepatitis B. The BBP standard
was upheld (except as to application in
certain limited industries) in American
Dental Association, which observed that
‘‘the infectious character’’ of the
regulated bloodborne diseases might
warrant ‘‘more regulation than would be
necessary in the case of a
noncommunicable disease.’’ 984 F.2d at
826. In addition, in the preamble to the
respiratory protection standard, 29 CFR
1910.134, which was also promulgated
under section 6(b)(5), ‘‘OSHA
emphasize[d] that [the] respiratory
protection standard does apply to
biological hazards.’’ Respiratory
Protection, 63 FR 1152–01, 1180 (Jan. 8,
1998) (citing Mahone Grain Corp., 10
BNA OSHC 1275 (No. 77–3041, 1981)).
In addition to being a physically
harmful agent covered by section
6(c)(1)(A), SARS–CoV–2 is also, without
question, a ‘‘new hazard’’ covered by
this provision, as discussed in more
detail in Grave Danger (Section III.A. of
this preamble). SARS–CoV–2 was not
known to exist until January 2020, and
since then more than 725,000 people
have died from COVID–19 in the U.S.
alone (CDC, October 18, 2021—
Cumulative US Deaths).
Turning to specific provisions of this
standard, the vaccination requirements
in this ETS are also well within the
bounds of OSHA’s authority.
Vaccination can be a critical tool in the
pursuit of health and safety goals,
particularly in response to an infectious
and highly communicable disease. See,
e.g., Jacobson v. Commonwealth of
Mass., 197 U.S. 11, 27–28 (1905)
(recognizing use of smallpox vaccine as
a reasonable measure to protect public
health and safety); Klaassen v. Trustees
of Ind. Univ., 7 F.4th 592, 593 (7th Cir.
2021) (citing Jacobson and noting that
vaccination may be an appropriate
safety measure against SARS–CoV–2 as
‘‘[v]accination protects not only the
vaccinated persons but also those who
come in contact with them’’). And the
OSH Act itself explicitly acknowledges
that such treatments might be necessary,
in some circumstances. 29 U.S.C.
669(a)(5) (providing in the Act’s
provisions on research and related
activities conducted by the Secretary of
Health and Human Services to aid
OSHA in its formulation of health and
safety standards that ‘‘[n]othing in this
or any other provision of this Act shall
be deemed to authorize or require
medical examination, immunization, or
treatment for those who object thereto
on religious grounds, except where such
is necessary for the protection of the
health or safety of others.’’ (emphasis
added)). In recognition of the health and
safety benefits provided by vaccination,
OSHA has previously exercised its
authority to promulgate vaccine-related
requirements in the COVID–19
Healthcare ETS (29 CFR 1910.502(m))
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2 OSHA notes that while the ETS does not impose
these testing or face covering costs on employers,
in some circumstances employers may be required
to pay for the costs related to testing and/or face
coverings by other laws, regulations, or collectively
negotiated agreements. OSHA has no authority
under the OSH Act to determine whether such
obligations under other laws, regulations, or
agreements might exist.
3 OSHA is defining the grave danger as workplace
exposure to SARS–CoV–2, the virus that causes the
development of COVID–19. COVID–19 is the
disease that can occur in people exposed to SARS-
CoV–2, and that leads to the health effects
described in this section. This distinction applies
despite OSHA’s use of the terms SARS–CoV–2 and
COVID–19 interchangeably in some parts of this
preamble.
4 OSHA refers to the grave danger from
occupational exposure to SARS–CoV–2 throughout
this document. Those references are intended to
encompass exposure to SARS–CoV–2 and all
variants of SARS–CoV–2, including the Delta
variant.
and the BBP standard (29 CFR
1910.1030(f)). The BBP standard
illustrates congressional understanding
that the statutory delegation of authority
to OSHA to issue standards includes
authority for vaccine provisions, where
appropriate. See Public Law 102–170,
Title I, Section 100, 105 Stat. 1107
(1991) (directing OSHA to complete the
BBP rulemaking by a date certain, and
providing that if OSHA did not do so,
the proposed rule, which included a
vaccine provision, would become the
final standard).
Additionally, OSHA’s authority to
require employers to bear the costs of
particular provisions of a standard is
solidly grounded in the OSH Act. The
Act reflects Congress’s determination
that the costs of compliance with the
Act and OSHA standards are part of the
cost of doing business and OSHA may
foreclose employers from shifting those
costs to employees. See Am. Textile
Mfrs. Inst., 452 U.S. at 514; Phelps
Dodge Corp. v. OSHRC, 725 F.2d 1237,
1239–40 (9th Cir. 1984); see also Sec’y
of Labor v. Beverly Healthcare-Hillview,
541 F.3d 193 (3d Cir. 2008). Consistent
with this authority, OSHA has largely
required employers to bear the costs of
the provisions of this ETS, including the
typical costs associated with
vaccination. The allocation of
vaccination costs to employers in this
ETS is similar to OSHA’s treatment of
vaccine-related costs in the COVID–19
Healthcare ETS and the BBP standards.
See 29 CFR 1910.502(m), (p); 29 CFR
1910.1030(f)(1)(ii)(A).
The OSH Act provides OSHA with
discretion, however, to decide whether
to impose certain costs—such as those
related to medical examinations or other
tests—on employers ‘‘[w]here [it
determines that such costs are]
appropriate.’’ 29 U.S.C. 655(b)(7). OSHA
has determined that for purposes of this
ETS, it would not be ‘‘appropriate’’ to
impose on employers any costs
associated with COVID–19 testing for
employees who choose not to be
vaccinated. For most of the agency’s
existing standards containing medical
testing and removal provisions, OSHA
has found it necessary to impose the
costs of such provisions on employers
in order to remove barriers to employee
participation in medical examinations
that are critical to effectuating the
standards’ safety and health protections.
See United Steelworkers of Am., 647
F.2d at 1229–31, 1237–38. However, as
explained in greater detail elsewhere in
this preamble (see Need for the ETS,
Section III.B. of this preamble), the
ETS’s safety and health protections are
best effectuated by employee
vaccination, not testing. Accordingly,
OSHA only requires employers to bear
the costs of employee compliance with
the preferred, and more protective,
vaccination provision, but not costs
associated with testing. The agency does
not believe it appropriate to impose the
costs of testing on an employer where
an employee has made an individual
choice to pursue a less protective
option. For the same reasons, OSHA has
also determined that it is not
appropriate to require employers to pay
for face coverings for employees who
choose not to be vaccinated.2
Finally, the Act and its legislative
history ‘‘both demonstrate
unmistakably’’ OSHA’s authority to
require employers to temporarily
remove workers from the workplace to
prevent exposure to a health hazard.
United Steelworkers of Am., 647 F.2d at
1230. And again, this is an authority
OSHA has repeatedly exercised in prior
standards, including in: COVID–19
Healthcare ETS (29 CFR 1910.502); Lead
(29 CFR 1910.1025); Cadmium (29 CFR
1910.1027); Benzene (29 CFR
1910.1028); Formaldehyde (29 CFR
1910.1048); Methylenedianiline (29 CFR
1910.1050); Methylene Chloride (29
CFR 1910.1052); and Beryllium (29 CFR
1910.1024). It is equally appropriate to
impose that obligation here.
For all of these reasons, as well as
those explained more fully in other
areas of this preamble, OSHA has the
authority—and obligation—to
promulgate this ETS.
References
Centers for Disease Control and Prevention
(CDC). (2021, October 18). COVID Data
Tracker. https://covid.cdc.gov/covid-
data-tracker/. (CDC, October 18, 2021)
III. Rationale for the ETS
A. Grave Danger
I. Introduction
Section 6(c)(1) of the OSH Act
requires the Secretary to issue an ETS in
situations where employees are exposed
to a ‘‘grave danger’’ and immediate
action is necessary to protect those
employees from such danger (29 U.S.C.
655(c)(1)). Consistent with its legal
duties, OSHA is issuing this ETS to
address the grave danger posed by
occupational exposure to SARS–CoV–2,
the virus that causes COVID–19.3 OSHA
has determined that occupational
exposure to SARS–CoV–2, including the
Delta variant (B.1.617.2 and AY
lineages), presents a grave danger to
unvaccinated workers in the U.S., with
several exceptions explained below.4
This finding of grave danger is based on
the science of how the virus spreads, the
transmissibility of the disease in
workplaces, and the serious adverse
health effects, including death, that can
be suffered by those who are diagnosed
with COVID–19. The protections of this
ETS—which will apply, with some
limitations, to a broad range of
workplace settings where exposure to
SARS–CoV–2 may occur—are designed
to protect employees from infection
with SARS–CoV–2 and from the dire,
sometimes fatal, consequences of such
infection.
The fact that COVID–19 is not a
uniquely work-related hazard does not
change the determination that it is a
grave danger to which employees are
exposed, nor does it excuse employers
from their duty to protect employees
from the occupational transmission of
SARS–CoV–2. The OSH Act is intended
to ‘‘assure so far as possible every
working man and woman in the Nation
safe and healthful working conditions’’
(29 U.S.C. 651(b)), and there is nothing
in the Act to suggest that its protections
do not extend to hazards which might
occur outside of the workplace as well
as within. Indeed, COVID–19 is not the
first hazard that OSHA has regulated
that occurs both inside and outside the
workplace. For example, the hazard of
noise is not unique to the workplace,
but the Fourth Circuit has upheld
OSHA’s Occupational Noise Exposure
standard (29 CFR 1910.95) (Forging
Industry Ass’n v. Sec’ of Labor, 773 F.2d
1437, 1444 (4th Cir. 1985)). Diseases
caused by bloodborne pathogens,
including HIV/AIDS and hepatitis B, are
also not unique to the workplace, but
the Seventh Circuit upheld the majority
of OSHA’s Bloodborne Pathogens
standard (29 CFR 1910.1030) (Am.
Dental Ass’n v. Martin, 984 F.2d 823
(7th Cir. 1993)). OSHA’s Sanitation
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5 See the definitions for the different levels of
severity of COVID–19 illness in the National
Institutes of Health’s COVID–19 treatment
guidelines (NIH, October 12, 2021).
6 When OSHA refers to ‘‘unvaccinated’’
individuals in its grave danger finding, it means all
individuals who are not fully vaccinated against
COVID–19, i.e., those who are completely
unvaccinated and those who are partially
vaccinated.
standard, 29 CFR 1910.141, which
requires measures such as cleaning,
waste disposal, potable water, toilets,
and washing facilities, addresses
hazards that exist everywhere—both
within and outside of workplaces.
Moreover, employees have more
freedom to control their environment
outside of work, and to make decisions
about their behavior and their contact
with others to better minimize their risk
of exposure. However, during the
workday, while under the control of
their employer, workers may have little
ability to limit contact with coworkers,
clients, members of the public, patients,
and others, any one of whom could
represent a source of exposure to SARS–
CoV–2. OSHA has a mandate to protect
employees from hazards they are
exposed to at work, even if they may be
exposed to similar hazards outside of
work.
As described above in Pertinent Legal
Authority (Section II. of this preamble),
‘‘grave danger’’ indicates a risk that is
more than ‘‘significant’’ (Int’l Union,
United Auto., Aerospace, & Agr.
Implement Workers of Am., UAW v.
Donovan, 590 F. Supp. 747, 755–56
(D.D.C. 1984); Indus. Union Dep’t, AFL–
CIO v. Am. Petroleum Inst., 448 U.S.
607, 640 n.45, 655 (1980) (stating that a
rate of 1 worker in 1,000 workers
suffering a given health effect
constitutes a ‘‘significant’’ risk)). ‘‘Grave
danger,’’ according to one court, refers
to ‘‘the danger of incurable, permanent,
or fatal consequences to workers, as
opposed to easily curable and fleeting
effects on their health’’ (Fla. Peach
Growers Ass’n, Inc. v. U.S. Dep’t of
Labor, 489 F.2d 120, 132 (5th Cir.
1974)). Fleeting effects were described
as nausea, excessive salivation,
perspiration, or blurred vision and were
considered so minor that they often
went unreported; these effects are in
stark contrast with the adverse health
effects of COVID–19 infections, which
are formally referenced as ranging from
‘‘mild’’ to ‘‘critical,’’ 5 but which can
involve significant illness, hospital
stays, ICU care, death, and long-term
health complications for survivors.
Beyond this, however, ‘‘the
determination of what constitutes a risk
worthy of Agency action is a policy
consideration that belongs, in the first
instance, to the Agency’’ (Asbestos Info.
Ass’n/N. Am. v. OSHA, 727 F.2d 415,
425 (5th Cir. 1984)).
In the context of ordinary 6(b)
rulemaking, the Supreme Court has said
that the OSH Act is not a ‘‘mathematical
straitjacket,’’ nor does it require the
agency to support its findings ‘‘with
anything approaching scientific
certainty,’’ particularly when operating
on the ‘‘frontiers of scientific
knowledge’’ (Indus. Union Dep’t, AFL–
CIO v. Am. Petroleum Inst., 448 U.S.
607, 655–56 (1980)). Courts reviewing
OSHA’s determination of grave danger
do so with ‘‘great deference’’ (Pub.
Citizen Health Research Grp. v.
Auchter, 702 F.2d 1150, 1156 (D.C. Cir.
1983)). In one case, the Fifth Circuit, in
reviewing an OSHA ETS for asbestos,
declined to question the agency’s
finding that 80 worker lives at risk
nationwide over six months constituted
a grave danger (Asbestos Info. Ass’n/N.
Am., 727 F.2d at 424). OSHA estimates
that this ETS would save over 6,500
worker lives and prevent over 250,000
hospitalizations over the course of the
next six months (OSHA, October 2021c).
Here, the mortality and morbidity risk to
employees from COVID–19 is so dire
that the grave danger from exposures to
SARS–CoV–2 is clear.
SARS–CoV–2 is both a physically
harmful agent and a new hazard (see 29
U.S.C. 655(c)(1)(A)). The majority of
OSHA’s previous ETSs addressed toxic
substances that had been familiar to the
agency for many years prior to issuance
of the ETS. OSHA’s Healthcare ETS,
issued in response to COVID–19 earlier
this year, is one notable exception. In
most cases, OSHA’s ETSs were issued in
response to new information about
substances that had been used in
workplaces for decades (e.g., Vinyl
Chloride (39 FR 12342 (April 5, 1974));
Benzene (42 FR 22516 (May 3, 1977));
1,2-Dibromo-3-chloropropane (42 FR
45536 (Sept. 9, 1977))). In some cases,
the hazards of the toxic substance were
already so well established that OSHA
promulgated an ETS simply to update
an existing standard (e.g., Vinyl cyanide
(43 FR 2586 (Jan. 17, 1978))). The
COVID–19 Healthcare ETS, which was
issued in June 2021, was the sole
instance in which OSHA issued an ETS
to address a grave danger from a
substance that had only recently come
into existence. Although that action by
the agency was challenged, the case has
not gone to briefing (see United Food &
Commercial Workers Int’l Union, AFL–
CIO, CLC and AFL–CIO v. OSHA, Dep’t
of Labor, D.C. Circuit No. 21–1143).
Thus, no court has had occasion to
examine OSHA’s authority under
section (6)(c) of the OSH Act (29 U.S.C.
655(c)) to address a grave danger from
a ‘‘new hazard.’’ Yet by any measure,
SARS–CoV–2 is a new hazard. Unlike
any of the hazards addressed in
previous ETSs, there were no
documented cases of SARS–CoV–2
infections in the United States until
January 2020. Since then, more than
725,000 people have died in the U.S.
alone (CDC, October 18, 2021—
Cumulative US Deaths). The pandemic
continues to affect workers and
workplaces, with workplace exposures
leading to further exposures among
workers’ families and communities.
Clearly, SARS–CoV–2 is both a
physically harmful agent and a new
hazard that presents a grave danger to
workers in the U.S.
Published on June 21, 2021, OSHA’s
Healthcare ETS (86 FR 32376) was
written in response to the grave danger
posed to healthcare workers in the
United States who faced a heightened
risk of infection from COVID–19. In the
healthcare ETS, OSHA described its
finding of grave danger for healthcare
and healthcare support service workers
(see 86 FR 32381–32412). OSHA now
finds that all unvaccinated workers,
with some exceptions, face a grave
danger from the SARS–CoV–2 virus.6
II. Nature of the Disease
The health effects of symptomatic
COVID–19 illness can range from mild
disease consisting of fever or chills,
cough, and shortness of breath to severe
disease. Severe cases can involve
respiratory failure, blood clots, long-
term cardiovascular and neurological
effects, and organ damage, which can
lead to hospitalization, ICU admission,
and death (see 86 FR 32383–32388;
NINDS, September 2, 2021). Even in the
short time since the Healthcare ETS’s
publication in June 2021, the risk posed
by COVID–19 has changed
meaningfully. Since OSHA considered
the impact of COVID–19 when
promulgating the Healthcare ETS, over
135,000 additional Americans have died
from COVID–19, and over 933,000 have
been hospitalized, (CDC, October 18,
2021—Cumulative US Deaths; CDC,
May 28, 2021; CDC, October 18, 2021—
Weekly Review). In August 2021,
COVID–19 was the third leading cause
of death in the United States, trailing
only heart disease and cancer (Ortaliza
et al., August 27, 2021). By September
20, 2021, COVID–19 had killed as many
Americans as the 1918–1919 flu
pandemic (Johnson, September 20,
2021).
While the Healthcare ETS addresses
the risk of illness and death from
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COVID–19 as the SARS–CoV–2 virus
continues to change over time, it does
not specifically address the increases in
infectiousness and transmission, and
the potentially more severe health
effects, related to the Delta variant. The
rapid rise to predominance of the Delta
variant in the U.S. occurred shortly after
the ETS was published. At this time, the
widespread prevalence of the Delta
variant and its increased
transmissibility have resulted in
increased risk of exposure and disease
relative to the previously-dominant
strains of the SARS–CoV–2 virus.
Adding to the information covered in
the Healthcare ETS, the following
sections provide a brief review of
SARS–CoV–2 and describe the
characteristics of the Delta variant that
are different from previous versions of
SARS–CoV–2 and have changed the
risks posed by COVID–19. The agency
specifically references the material
presented in the Healthcare ETS, which
is still relevant to this analysis, to
support OSHA’s finding of grave danger.
Taken together, the information
available to OSHA demonstrates that
SARS–CoV–2 poses a grave danger to
unvaccinated workers across all
industry sectors.
a. Variants of SARS–CoV–2
Viral mutations have been a serious
concern of scientists, public health
experts, and policymakers from the
beginning of the COVID–19 pandemic.
Viral mutations can affect how a virus
interacts with a cell—altering the virus’s
transmissibility, infection severity, and
sensitivity to vaccines. The U.S.
government’s SARS–CoV–2 Interagency
Group has a variant classification
scheme that defines four classes of
SARS–CoV–2 variants: Variants Being
Monitored (VBM), Variants of Interest
(VOI), Variants of Concern (VOC), and
Variants of High Consequence (VOHC).
These variant designations are based on
their ‘‘proportions at the national and
regional levels and the potential or
known impact of the constellation of
mutations on the effectiveness of
medical countermeasures, severity of
disease, and ability to spread from
person to person’’ (CDC, October 4,
2021), with VOIs considered less serious
than VOCs and VOCs considered less
serious than VOHCs. As of early October
2021, the CDC was monitoring 10
VBMs—Alpha (B.1.1.7, Q.1–Q.8), Beta
(B.1.351, B.1.351.2, B.1.351.3), Gamma
(P.1, P.1.1, P.1.2), Epsilon (B.1.427 and
B.1.429), Eta (B.1.525), Iota (B.1.526),
Kappa (B.1.617.1), B.1.617.3, Mu
(B.1.621, B.1.621.1), and Zeta (P.2)—and
one VOC—Delta (B.1.617.2 and AY.1
sublineages)—in the U.S. (CDC, October
4, 2021). CDC defines a VOC as ‘‘[a]
variant for which there is evidence of an
increase in transmissibility, more severe
disease (e.g., increased hospitalizations
or deaths), significant reduction in
neutralization by antibodies generated
during previous infection or
vaccination, reduced effectiveness of
treatments or vaccines, or diagnostic
detection failures’’ (CDC, October 4,
2021).
While the proportions of SARS–CoV–
2 variants in the United States have
shifted over time (CDC, May 24, 2021c;
CDC, October 18, 2021—Variant
Proportions, July through October 2021),
the primary variant that drove COVID–
19 transmission in the late Winter and
Spring of 2021 was the Alpha variant.
The CDC noted that Alpha is associated
with an increase in transmission, as
well as potentially increased incidences
of hospitalization and death, compared
to the predominant variants before its
emergence (CDC, October 4, 2021;
Pascall et al., August 24, 2021; Julin et
al., September 22, 2021). As Alpha
transmission subsided in the United
States during the late Spring and early
Summer of 2021, Delta emerged and
quickly became the predominant variant
in the U.S. by July 3, 2021 (CDC,
October 18, 2021—Variant Proportions,
July through October 2021). Delta now
accounts for more than 99% of
circulating virus nationwide (CDC,
October 18, 2021—Variant Proportions,
July through October 2021).
FDA authorized and approved
COVID–19 vaccines currently work well
against all of these variants; however,
there are differences in various variants’
ability to spread and the likelihood of
infection to cause severe illness. Data on
the Beta and Gamma variants do not
indicate that infections from these
variants caused more severe illness or
death than other VOCs. Data on the
Alpha variant does indicate its ability to
cause more severe illness and death in
infected individuals. And some data on
the Delta variant suggests that the Delta
variant may cause more severe illness
than previous variants, including Alpha,
in unvaccinated individuals (CDC,
October 4, 2021).
The emergence of the Delta variant,
along with other VOCs, has resulted in
a more deadly pandemic (Fisman and
Tuite, July 12, 2021). While the Delta
variant is the most transmissible SARS–
CoV–2 variant to date, the possibility
remains for the rise of future VOCs, and
even more dangerous VOHCs, as the
virus continues to spread and mutate.
Inadequate vaccination rates and the
abundance of transmission create an
environment that can foster the
development of new variants that could
be similarly, or even more, disruptive
(Liu and Rocklov, August, 4, 2021). In
this context, it is critical that OSHA
address the grave danger from COVID–
19 that unvaccinated workers are
currently facing by requiring
vaccination and the other measures
included in this rule, in order to
significantly slow the transmission of
COVID–19 in workers and workplaces
and mitigate the rise of future variants.
b. Transmission
SARS–CoV–2 is a highly
transmissible virus, regardless of
variant. Since the first case was detected
in the U.S., there have been close to 45
million reported cases of COVID–19,
affecting every state and territory, with
thousands more infected each day (CDC,
October 18, 2021—Cumulative US
Cases), and some indication that these
numbers continue to underestimate the
full burden of disease (CDC, July 27,
2021). According to the CDC, the
primary way the SARS–CoV–2 virus
spreads from an infected person to
others is through the respiratory
droplets that are produced when an
infected person coughs, sneezes, sings,
talks, or breathes (CDC, May 7, 2021).
Infection could then occur when
another person breathes in the virus.
Most commonly this occurs when
people are in close contact with one
another in indoor spaces (within
approximately six feet for at least fifteen
minutes) (CDC, August 13, 2021).
Additionally, airborne transmission may
occur in indoor spaces without adequate
ventilation where small respiratory
particles are able to remain suspended
in the air and accumulate (CDC, May 7,
2021; Fennelly, July 24, 2020). While
scientists’ understanding of the Delta
variant’s virology is evolving and
remains at the frontier of science,
current data shows that the routes of
transmission remain the same for all
currently-identified SARS–CoV–2
variants. In addition, all variants can be
transmitted by people who are pre-
symptomatic (i.e., people who are
infected but do not yet feel sick) or
asymptomatic (i.e., people who are
infected but never feel any symptoms of
COVID–19), as well as those who are
symptomatic. Pre-symptomatic and
asymptomatic transmission continue to
pose serious challenges to containing
the spread of COVID–19. For more
extensive information on transmission
routes, as well as pre-symptomatic and
asymptomatic transmission, see the
preamble to the Healthcare ETS (86 FR
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7 This adoption includes the citations in the
referenced section of the Healthcare ETS, which are
also included in the docket for this ETS.
8 Risk of death is based on averages from reported
CDC data. Risks of hospitalization and death are
much higher in unvaccinated individuals, as
discussed further in Grave Danger, Section III.A.IV.
Vaccines Effectively Reduce Severe Health
Outcomes from and Transmission of SARS–CoV–2.
9 This adoption includes the citations in the
referenced section of the Healthcare ETS, which are
also included in the docket for this ETS.
32392–32396), which is hereby
included in the record of this ETS.7
The Delta variant is transmitted from
infectious individuals via the same
routes as previous variants, but is much
more transmissible. Specifically, Delta
differs from previous dominant variants
of SARS–CoV–2 in terms of the
amplification of viral particles expelled
from infected individuals. Testing of
Delta-infected individuals indicates that
their viral loads are—on average—
approximately 1,000x greater than those
of the SARS–CoV–2 variants from the
first COVID–19 wave in early 2020. This
finding suggests much faster replication
of viral particles during early infection
with the Delta variant, resulting in
greater infectiousness (contagiousness)
when compared to earlier versions of
SARS–CoV–2 (Li et al., July 12, 2021).
The transmissibility of viruses is
measured in part by the average number
of subsequently-infected people (or
secondary cases) that are expected to
occur from each existing case (often
referred to as R0). Several comparisons
of the transmissibility of the initial
SARS–CoV–2 variants to the Delta
variant have shown that Delta is
approximately twice as transmissible
(contagious) as previous versions of
SARS–CoV–2 (CDC, August 26, 2021;
Riou and Althaus, January 30, 2020; Li
et al., July 12, 2021; Liu and Rocklov,
August, 4, 2021), likely the result of
higher initial viral loads during the pre-
symptomatic phase (Li et al., July 12,
2021). In addition, as described further
below, data on Delta shows that both
unvaccinated and vaccinated
individuals are more likely to transmit
Delta than previous variants (Liu and
Rocklov, August, 4, 2021; Eyre et al.,
September 29, 2021), making it
especially dangerous to those who
remain unvaccinated.
c. Health Effects
COVID–19 infections can lead to
death. As reported in the Healthcare
ETS, by May 24, 2021, there had been
587,432 deaths and 32,947,548 million
infections in the U.S. alone (CDC, May
24, 2021a; CDC, May 24, 2021b). At that
point in the pandemic, 1.8 out of every
1,000 people in the U.S. had died from
COVID–19 (CDC, May 24, 2021a). Since
then, reported cases have increased to
44,857,861 and the number of deaths
has increased to 723,205 (CDC, October
18, 2021– Cumulative US Cases;
Cumulative US Deaths). By September
2021, an astounding 1 in 500 Americans
had died from COVID–19 (Keating,
September 15, 2021). Updated mortality
data 8 currently indicate that people of
working age (18–64 years old) now have
a 1 in 202 chance of dying when they
contract the disease, with the risk much
higher (1 in 72) for those aged 50–64
(CDC, October 18, 2021—Demographic
Trends, Cases by Age Group; CDC,
October 18, 2021—Demographic Trends,
Deaths by Age Group). For a more in-
depth description of the health effects
resulting from SARS–CoV–2 infection,
see the preamble to the Healthcare ETS
(86 FR 32383–32392), which is hereby
included in the record of this ETS.9
Apart from fatal cases, COVID–19 can
cause serious illness, including long-
lasting effects on health. Many patients
who become ill with COVID–19 require
hospitalization. Indeed, updated CDC
hospitalization and mortality data
indicate that working age Americans
(18–64 years old) now have a 1 in 14
chance of hospitalization when infected
with COVID–19 (CDC, October 18,
2021—Demographic Trends, Cases by
Age; Total Hospitalizations, by Age).
Those who are hospitalized frequently
need supplemental oxygen and
treatment for the disease’s most
common complications, which include
pneumonia, respiratory failure, acute
respiratory distress syndrome (ARDS),
acute kidney injury, sepsis, myocardial
injury, arrhythmias, and blood clots.
One study, which included 35,502
inpatients nationwide, determined that
the median length of hospital stay was
6 days, unless the cases required ICU
treatment. For those cases, ICU stays
were on median 5 days in addition to
the time spent hospitalized outside of
the ICU (Rosenthal et al., December 10,
2020). Another study that assessed
hospital length of stay for COVID–19
patients in England estimated that a
non-ICU hospital stay averaged between
8 and 9 days, but those estimates ranged
from approximately 12 to 18 days when
patients were admitted to the ICU
(Vekaria et al., July 22, 2021). Moreover,
given that SARS–CoV–2 is still a novel
virus, the severity of long-term health
effects—such as ‘‘post-COVID
conditions’’—are not yet fully
understood.
Many members of the workforce are at
increased risk of death and severe
disease from COVID–19 because of their
age or pre-existing health conditions.
The comorbidities that further
exacerbate COVID–19 infections are
common among adults of working age in
the U.S. For instance, 46.1% of
individuals with cancer are in the 20–
64 year old age range (NCI, April 29,
2015), and over 40% of working age
adults are obese (Hales et al., February
2020). Disease severity is also likely
exacerbated by long-standing healthcare
inequities experienced by members of
many racial and economic
demographics (CDC, April 19, 2021).
Recent data suggests that Delta variant
infections may result in even more
severe illness and a higher frequency of
death than previous COVID–19 variants
due to Delta’s increased transmissibility,
virulence, and immune escape (Fisman
and Tuite, July 12, 2021). Symptomatic
Delta variant infections do occur in fully
vaccinated people (Mlcochova et al.,
June 22, 2021; Musser et al., July 22,
2021); however, as reported by the CDC
(CDC, August 26, 2021), the vast
majority of the continuing instances of
severe and fatal COVID–19 infections
are occurring in unvaccinated persons
(discussed further in Grave Danger,
Section III.A.IV. Vaccines Effectively
Reduce Severe Outcomes from and
Transmission of SARS–CoV–2). An
assessment of Delta-related hospital
admissions in Scotland found that
hospitalizations were approximately
doubled in patients with the Delta
variant when compared to the Alpha
variant (Sheikh et al., June 4, 2021). A
similar study conducted using a
retrospective cohort in Ontario, Canada
compared the virulence of novel SARS–
CoV–2 variants and found that the
incidences of hospitalization, ICU
admission, and death were more
pronounced with the Delta variant than
any other SARS–CoV–2 variant (Fisman
and Tuite, July 12, 2021). A large
national cohort study that included all
Alpha and Delta SARS–CoV–2 patients
in England between March 29 and May
23, 2021 found a ‘‘higher hospital
admission or emergency care attendance
risk for patients with COVID–19
infected with the Delta variant
compared with the Alpha variant,’’
suggesting that Delta outbreaks—
especially amongst unvaccinated
populations—may lead to more severe
health consequences and an equivalent
or greater burden on healthcare services
than the Alpha variant (Twohig et al.,
August 27, 2021). However, one more
recent study examining data from
several U.S. states demonstrated a
significant increase in hospitalization
from the pre-Delta to the Delta period,
which may be related to increased
transmissibility of Delta rather than
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10 OSHA did not make findings based solely on
non-peer-reviewed sources such as news articles,
but the agency found that those sources can
sometimes provide useful information when
considered with more robust sources.
more severe health outcomes (Taylor et
al., October 22, 2021).
III. Impact on the Workplace
SARS–CoV–2 is readily transmissible
in workplaces because they are areas
where multiple people come into
contact with one another, often for
extended periods of time. When
employees report to their workplace,
they may regularly come into contact
with co-workers, the public, delivery
people, patients, and any other people
who enter the workplace. Workplace
factors that exacerbate the risk of
transmission of SARS–CoV–2 include
working in indoor settings, working in
poorly-ventilated areas, and spending
hours in close proximity with others.
Full-time employees typically spend 8
hours or more at work each shift, more
time than they spend anywhere else but
where they live. Employees work in
proximity to others in workplaces that
were not originally designed to keep
people six feet away from other people
and that may make it difficult for
employees to perform work tasks while
maintaining a six-foot distance from
others. Even in the cases where workers
can do most of their work from, for
example, a private office within a
workplace, they share common areas
like hallways, restrooms, lunch rooms
and meeting rooms. Furthermore, many
work areas are poorly ventilated (Allen
and Ibrahim, May 25, 2021; Lewis,
March 30, 2021). An additional factor
that exacerbates the risk of transmission
of SARS–CoV–2 is interacting with or
caring for people with suspected or
confirmed COVID–19; this was a
primary driver of OSHA’s determination
of grave danger for healthcare workers
in the Healthcare ETS (see 86 FR 32381–
32383). In recent weeks, the majority of
states in the U.S. have experienced what
CDC defines as ‘‘high or substantial
community transmission,’’ indicating
that there is a clear risk of the virus
being introduced into and circulating in
workplaces (CDC, October 18, 2021—
Community Transmission Rates).
Although COVID–19 is not
exclusively an occupational disease, it
is evident from research accrued since
the beginning of the pandemic that
SARS–CoV–2 transmission can and
does occur in workplaces, affecting
employees and their lives, health, and
livelihoods. This continues to be true
for the Delta variant, with its increased
transmissibility and potentially more
severe health effects. This section
describes some of the clusters,
outbreaks, and other occurrences of
workplace COVID–19 cases that
government agencies, researchers, and
journalists have described, and the
widespread effects of SARS–CoV–2 in
industry sectors across the national
economy. While the focus is on more
recent data reflecting the impact of the
Delta variant, evidence of workplace
transmission that occurred prior to the
emergence of the Delta variant is also
presented.
The workplace-based clusters
described below provide evidence that
workplaces in a wide range of industries
have been affected by COVID–19, that
many employees face exposure to
infected people in their workspaces, and
that SARS–CoV–2 transmission is
occurring in the workplace, including
during the recent period where the Delta
variant has predominated. Although the
presence of a cluster on its own does not
necessarily establish that the cluster is
work-related (i.e., a result of
transmission at the worksite), many
state investigation reports and
published studies provide evidence that
transmission is work related by
documenting that infections at a
workplace occurred within 14-days (the
incubation period for the virus) of each
other and ruling out the possibility that
transmission occurred outside the
workplace. In addition, the information
below demonstrates that exposures to
SARS–CoV–2 happen regularly in a
wide variety of different types of
workplaces.
The basis for OSHA’s grave danger
finding is that employees can be
exposed to the virus in almost any work
setting; that exposure to SARS–CoV–2
can lead to infection (CDC, September
21, 2021); and that infection in turn can
cause death or serious impairment of
health, especially in those who are
unvaccinated (see Section III.A.IV.
Vaccines Effectively Reduce Severe
Health Outcomes from and
Transmission of SARS–CoV–2). The
information described in this section
supports OSHA’s finding that
employees who work in spaces shared
by others are at risk of exposure to
SARS–CoV–2. The degree of risk from
droplet-based transmission may vary
based on the duration of close proximity
to a person infected with SARS–CoV–2,
including the Delta variant, but the
simple and brief act of sneezing,
coughing, talking, or even breathing can
significantly increase the risk of
transmission if controls are not in place.
SARS–CoV–2, including the Delta
variant, might also be spread through
airborne particles under certain
conditions, particularly in enclosed
settings with inadequate ventilation,
which are common characteristics of
some workplaces.
The peer-reviewed scientific journal
articles, government reports, and news
articles described below establish the
widespread prevalence of COVID–19
among employees, beginning with a
description of the recent impact from
the Delta variant. OSHA’s findings are
based primarily on the evidence from
peer-reviewed scientific journal articles
and government reports. However, peer
review for scientific journal articles and
the assembly of information for
government reports and other official
sources of information take time, and
therefore those sources do not always
reflect the most up-to-date information
(Chan et al., December 14, 2010). In
addition, while state and local health
departments can report workplace
outbreaks to CDC, the agency does not
provide summary statistics by
workplace so that those outbreaks can
be tracked on a national level. In the
context of the COVID–19 pandemic,
given the recent impacts due to the
Delta variant and the emergence of new
information on a daily basis, it is critical
for OSHA to rely on the most up-to-date
information available. Therefore, OSHA
has occasionally supplemented peer-
reviewed data and government reports
with additional information on
occupational outbreaks contained in
other sources of media (e.g.,
newspapers, digital media, and
information submitted to or obtained by
private organizations).10 The reported
information from other sources can
provide further evidence of the impact
of an emerging and changing disease,
especially for industries that are not
well represented in the peer-reviewed
scientific literature. Together, these
sources of information represent the
best available evidence of the impact on
employees of the pandemic thus far.
The information described herein
illustrates a significant number of
infections among employees in a variety
of industries, with virtually every state
continuing to experience what CDC
defines as high or substantial
community transmission related to the
recent surge of the Delta variant. The
industries and types of workplaces
described are not the only ones in
which a grave danger exists. The science
of transmission does not vary by
industry or by type of workplace. OSHA
therefore expects transmission to occur
in diverse workplaces all across the
country (see Dry Color Mfrs. Ass’n, Inc.
v. Dep’t of Labor, 486 F.2d 98, 102 n.3
(3d Cir. 1973) (holding that when OSHA
determines a substance poses a grave
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11 NCDHHS identifies a ‘‘workplace’’ category in
their report (e.g., agriculture, construction), but
OSHA includes other settings where employees
would be present (e.g., retail, restaurants, childcare,
healthcare).
danger to workers, OSHA can assume an
exposure to a grave danger exists
wherever that substance is present in a
workplace)). In addition, the severity of
COVID–19 does not depend on where
an employee is infected; an employee
exposed to SARS–CoV–2 might die
whether exposed while working at a
meat packing facility, a retail
establishment, or an office (see Grave
Danger, Section III.A.V.b. Employees
Who Work Exclusively Outside, below,
for a discussion of the risk of exposure
in outdoor workplaces).
a. General Impact on Workers
Data on SARS–CoV–2 infections,
illnesses, and deaths among employees
in general industry, agriculture,
construction, and maritime support
OSHA’s finding that COVID–19 poses a
grave danger to employees in these
sectors across the U.S. economy. This
section summarizes studies and reports
of COVID–19 illness and fatalities in a
wide range of workplaces across those
industry sectors. Not all workplace
settings are discussed; nor is the data
available to do so. However, the
characteristics of the various affected
workplaces—such as indoor work
settings; contact with coworkers, clients,
or members of the public; and sharing
space with others for prolonged periods
of time—indicate that exposures to
SARS–CoV–2 are occurring in a wide
variety of work settings across all
industries. Therefore, most employees
who work in the presence of other
people (e.g., co-workers, customers,
visitors) need to be protected.
While there is no comprehensive
source of nationwide workplace
infection data, reports from states and
communities on outbreaks related to
workplaces provide key, up-to-date data
that illustrate the likelihood of
employee exposure to SARS–CoV–2 at
workplaces throughout the U.S. OSHA
identified a number of recent reports
from various regions of the country that
together demonstrate the impact that
SARS–CoV–2 can have on a variety of
workplaces, including in service
industries (e.g., restaurants, grocery and
other retail stores, fitness centers,
hospitality, casinos, salons), corrections,
warehousing, childcare, schools, offices,
homeless shelters, transportation, mail/
shipping/delivery services, cleaning
services, emergency services/response,
waste management, construction,
agriculture, food packaging/processing,
and healthcare. Deaths are reported in
many studies performed prior to the
emergence of the Delta variant but,
because the Delta outbreak is so recent
and deaths can occur weeks after
infection, the number of deaths from
recent infections might be
underestimated. Some of the reports
include cumulative data representing
various phases of the pandemic,
beginning prior to the availability of
vaccines and continuing through the
recent surge of the Delta variant. In
addition, some studies report
investigations of recent outbreaks,
which provide insight on the impact of
the Delta variant as well as impacts
associated with the current vaccination
status of workers.
The Washington State Department of
Health (WSDH) reports outbreaks
occurring in non-healthcare workplaces
(WSDH, September 8, 2021). In non-
healthcare workplaces, outbreaks are
defined as two or more laboratory
confirmed cases of COVID–19, with at
least two cases reporting symptom onset
within 14 days of each other, and
plausible epidemiological evidence of
transmission in a shared location other
than a household. As of September 4,
2021, WSDH reported 5,247 outbreaks
in approximately 40 different types of
non-healthcare work settings. During
the week of August 29 through
September 4, 2021, WSDH identified
137 separate workplace outbreaks. The
types of non-medical workplace settings
that represented more than 5% of the
total outbreaks during that week
included food service/restaurants,
childcare, schools, retail, grocery, and
shelter/homeless services. Other types
of non-healthcare settings where
outbreaks occurred recently included
non-food and food manufacturing,
construction, professional services/
office based, agriculture/produce
packing, transportation/shipping
delivery, government agencies/facilities,
leisure hospitality/recreation,
corrections, utilities, warehousing,
facility/domestic cleaning services,
youth sports/activities, camps, and
public safety. Over the course of the
pandemic, outbreaks have also been
observed at bars/nightclubs, hotels, and
fishing/commercial seafood vessels.
The Oregon Health Authority (OHA)
publishes a weekly report detailing
outbreaks directly related to work
settings. OHA epidemiologists consider
cases to be part of a workplace outbreak
when clusters form with respect to
space and time, within a plausible
incubation period for the virus, and
their investigation does not uncover an
alternative source for the outbreak. For
privacy reasons, OHA only reports
outbreaks with 5 or more cases in
workplaces with 30 or more people.
OHA reported a total of 26,013 cases
and 135 deaths related to workplace
outbreaks as of September 1, 2021. As
of September 1, 2021, OHA was
investigating more than 124 active
workplace outbreaks (OHA, September
1, 2021). Those outbreaks occurred in a
wide variety of industries including
correctional facilities, emergency
services, waste management, schools
and child care, retail and grocery stores,
restaurants, warehousing, agriculture,
food processing/packaging,
construction, healthcare, mail and
delivery services, office locations,
utilities, transportation, and others.
Tennessee Department of Health was
investigating 557 active COVID–19
clusters as of September 8, 2021 (TDH,
September 8, 2021). Clusters are defined
as two or more laboratory confirmed
COVID–19 cases linked to the same
location or event that is not a household
exposure. The clusters occurred in 13
types of settings, 10 of which were
workplace settings. Outbreaks at
workplaces represented more than half
of the total active outbreaks in the state
at that time. Settings comprising more
than 5% of total clusters included
assisted care living facilities, nursing
homes, and correctional facilities. Other
types of workplaces where outbreaks
occurred included bars, construction,
farms, homeless shelters, and industrial
settings.
The North Carolina Department of
Health and Human Services reports
cumulative numbers of clusters, cases,
and deaths for workers in poultry
processing facilities (beginning in April
of 2020) and other types of workplaces
(beginning in May of 2020) (NCDHHS,
August 30, 2021). Clusters are defined
as a minimum of 5 cases with illness
onset or initial positive results within a
14-day period and plausible
epidemiological linkage between the
cases. Plausible epidemiological linkage
means that multiple cases were in the
same general setting during the same
time period (e.g., same shift, same
physical area) and that a more likely
source of exposure is not identified (e.g.,
household contact or close contact to a
confirmed case in another setting).
During that time period of April/May
2020 through August 30, 2021,
workplaces 11 were associated with
nearly 80% of the 1,969 clusters and
27,097 cases observed and nearly 40%
of the 167 deaths related to the clusters.
Cumulative numbers of cluster-
associated deaths were highest in meat
and poultry processing (25 of 5,351
cases), followed by healthcare (10 of
1,036 cases), government services and
manufacturing (5 of 1,048 cases and 5 of
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1,856 cases, respectively), and
restaurants and childcare (3 of 421 cases
and 3 of 1,943 cases, respectively).
Recently, in July of 2021, the number of
cases associated with workplace clusters
began increasing in several different
types of work settings, including meat
processing, manufacturing, retail,
restaurants, childcare, schools, and
higher education.
Colorado Department of Public Health
& Environment/Colorado State
Emergency Operations Center (CDPHE/
CSEOC, September 8, 2021) reported
5,584 resolved workplace-related
outbreaks involving 40,156 employee
cases and 79 employee deaths since
May of 2020. The agency’s current
investigations, as of September 8, 2021
included 291 active outbreaks (not
defined), with 2,865 staff cases
(assumed to be cases in employees). The
majority of active outbreaks were
reported in childcare, schools,
healthcare, and corrections. Active
outbreaks were also reported in
construction, retail, homeless shelters,
casinos, restaurants, hotels, offices, law
enforcement, manufacturing, delivery
services, and warehouses. Other types of
work settings that were affected in
resolved outbreaks included
warehouses, bars, government locations,
waste management, utilities, salons,
emergency services, meat processing/
packaging, and postal services. From
June 21, 2021 (the date the healthcare
ETS was published) through September
8, 2021, 1,469 staff cases associated with
outbreaks were reported, for an average
of approximately 19 cases per day.
Similar reporting is available from
Louisiana’s Department of Health (LDH,
August 24, 2021), with 1,347 outbreaks
and 9,130 cases reported as of August
24, 2021. LDH defines an outbreak as 2
or more cases among unrelated
individuals who visited a site within a
14-day period. More than three quarters
of outbreaks through that date were
associated with workplaces. Workplace
settings in Louisiana that experienced
more than 5% of outbreaks included
day care facilities, bars, restaurants,
retail settings, industrial settings, and
office spaces. Other types of workplace
settings or industries where outbreaks
occurred included casinos, gyms/fitness
centers, banks, automotive services,
construction, and ships/boats.
In addition to the state data above,
some published studies and government
reports provide information on recent
workplaces outbreaks. For example, 47
people, including 3 of 11 staff members,
23 gymnasts, and 21 household
contacts, contracted COVID–19 from an
outbreak linked to an Oklahoma
gymnastics facility during April 15
through May 3, 2021 (Dougherty et al.,
July 16, 2021). All 21 of the virus
samples sequenced were determined to
be the Delta variant. The majority of the
infected individuals (85%) were
unvaccinated. Infections were reported
in 16 adults aged 20 years or older; two
adults were hospitalized and one
required intensive care.
The state of Hawaii defines clusters as
three or more confirmed or probable
cases linked to a site or event within 14
days, with no outside exposure of cases
to each other (Hawaii State, August 19,
2021). The state reported a COVID–19
cluster in July associated with a concert
at a bar that affected 16 people,
including employees, band members,
and concert attendees; infections also
spread to 7 household members. Band
members had performed while sick.
Four of the initial 16 people and none
of the household members who tested
positive for COVID–19 were fully
vaccinated. The concert cluster was
linked to clusters at another workplace
and another concert. The report lists
additional clusters investigated in the
two weeks prior to the report; those
clusters were observed in workplace
locations such as correctional facilities,
bars and nightclubs, restaurants,
construction/industrial sites, travel/
lodging/tourism, schools, food
suppliers, and gyms.
Additional evidence that employees
are at risk of exposure to SARS–CoV–2
in the workplace is available from
published, peer-reviewed studies that
were conducted before the Delta variant
emerged. Those studies demonstrate
that employees have been at risk of
infection, illness, and death throughout
the COVID–19 pandemic. Because the
Delta variant is more transmissible and
likely causes more severe disease than
previous variants, there is even greater
potential for unvaccinated employees to
become seriously ill or die as a result of
exposure to the Delta variant.
Contreras et al. (July, 2021) examined
workplace outbreaks (excluding
healthcare settings, homelessness
services, and emergency medical
services) in Los Angeles county from
March 19 through September 30, 2020.
Workplace outbreaks were defined as 5
or more suspected or laboratory
confirmed COVID–19 cases (prior to
May 29) or 3 or more laboratory
confirmed cases (after May 29)
occurring within 14 days. Nearly 60% of
the 698 identified outbreaks occurred in
three sectors—manufacturing (184,
26.4%), retail trade (137, 19.6%), and
transportation and warehousing (73,
10.5%). Also notable were the 71
outbreaks in the accommodation and
food services industry, which
represented 10.2% of the outbreaks. The
study authors concluded that outbreaks
were larger and lasted longer at facilities
with more onsite staff.
Outbreaks in Wisconsin from March 4
through November 16, 2020 were also
examined (Pray et al., January 29, 2021).
Non-household outbreaks were defined
as two or more confirmed COVID–19
cases that occurred within 14 days in
persons who attended the same facility
or event and did not share a household.
During the period from March 4 through
November 16, 2020, the largest
percentages of cases were associated
with outbreaks in long-term care
facilities (26.8% of cases), correctional
facilities (14.9% of cases), and colleges
or universities (15% of cases). Also
notable were the substantial number of
cases associated with outbreaks in food
production or manufacturing facilities
(including meat processing and
warehousing; 14.5% of cases) and
schools and childcare facilities (10.6%
of cases).
Bui et al. (August 17, 2020) analyzed
data from the Utah Department of
Health’s COVID–19 case surveillance
system, which included data on
workplace outbreaks. Outbreaks were
defined as two or more laboratory
confirmed cases occurring within a 14
day period among coworkers in a
common workplace (e.g., same facility).
During the time period between March
6 and June 5, 2020, 277 COVID–19
outbreaks were reported, of which 210
(76%) occurred in workplaces. The 210
workplace outbreaks occurred in 15 of
20 industry sectors, and the industry
sectors of manufacturing (43 outbreaks,
20%), construction (32 outbreaks, 15%),
and wholesale trade (29 outbreaks, 14%)
together represented nearly half of
workplace outbreaks. Other sectors that
represented more than 10% of total
outbreaks were retail trade (28
outbreaks, 13%) and accommodation
and food services (25 outbreaks, 12%).
Incidence rates of COVID–19 over the
period of March 6 through June 5, 2020
were 339/100,000 workers in
manufacturing, 122/100,000 workers in
construction, 377/100,000 workers in
wholesale trade, 68/100,000 workers for
retail trade, and 78/100,000 workers for
accommodation and food services. For
COVID–19 cases associated with
workplace outbreaks in which
hospitalization and severity status were
known (1,382 and 1,155, respectively),
the number in all sectors who were
admitted to the hospital was 85 (6%)
and the number with severe outcomes
(intensive care unit admission,
mechanical ventilation, or death) was 40
(3%).
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The impact of SARS–CoV–2
exposures on employee infection,
illness, and death has also been
demonstrated in studies focusing on
specific types of industries, such as
those where employees have frequent
contact with each other and the public
(e.g., grocery stores, bars, fitness
facilities, schools, and law enforcement/
corrections). For example, a study by
Lan et al. (September 26, 2020)
demonstrates the risk of infection in
service industries. The cross-sectional
study examined the risks of SARS–CoV–
2 exposure and infection for employees
in a Boston, Massachusetts-area retail
grocery store market. The study tested
104 grocery store employees, of whom
20% (21 employees) were positive for
COVID–19; 76% of confirmed cases did
not have symptoms. After adjusting for
gender, smoking, age, and the
prevalence of COVID–19 in the
employees’ residential communities,
employees who had direct customer
exposure (e.g., cashiers, sales associates,
cart attendants) were 5.1 times more
likely to have a positive test for COVID–
19 than employees without direct face-
to-face customer exposure (e.g.,
stockers, backroom, receiving and
maintenance). The infection rate of 20%
among all employees was significantly
higher than the rate in the surrounding
community.
In February of 2021, an event at an
Illinois bar that accommodates
approximately 100 people resulted in a
COVID–19 outbreak that affected 46
people, including 3 (10%) staff
members, 26 (90%) patrons, and 17
secondary cases (Sami et al., April 9,
2021). People at the event included an
asymptomatic person diagnosed with
COVID–19 on the previous day and 4
symptomatic people who were later
diagnosed with COVID–19. The
outbreak resulted in a school closure
and the hospitalization of a resident at
a long-term care facility.
In Minnesota, 47 COVID–19 outbreaks
were detected at fitness facilities from
August through November of 2020
(Suhs et al., July 23, 2021). One
outbreak at a fitness facility during
October through November of 2020
resulted in 23 COVID–19 cases
including 5 (22%) employees and 18
(78%) members. A genetic analysis of
specimens from 3 employees and 10
members identified 2 distinct genetic
subclusters, indicating two distinct
chains of transmission among members
and employees.
School-related outbreaks were
examined from December 1, 2020
through January 22, 2021 in eight public
elementary schools of a Georgia school
district (Gold et al., February 26, 2021).
A COVID–19 case was determined to be
school-related if (1) symptom onset or a
positive test was consistent with the
incubation period of the virus following
contact with an index case or a school-
associated case, (2) close contact
occurred with the index case or school-
associated case while that person was
infected, and (3) no known contact
occurred with an infected community or
household contact in the two weeks
prior to a positive test for COVID–19.
The investigators identified nine
clusters of three or more
epidemiologically linked COVID–19
cases that involved 13 educators and 32
students in six of the eight elementary
schools. Approximately half of the
school-associated cases involved two
clusters that began with probable
transmission between educators,
followed by educator to student
transmission. Eighteen of 69 household
members tested received positive
results.
A number of studies demonstrate the
impact of COVID–19 in law enforcement
and related fields such as corrections.
For example, a study examining
COVID–19 antibodies in employees
from public service agencies in the New
York City area from May through July of
2020, found that 22.5% of participants
had COVID–19 antibodies (Sami et al.,
March, 2021). The percentage of
correctional officers found to have
COVID–19 antibodies (39.2%) was the
highest observed among all the
occupations. The percentages of police
dispatchers, traffic officers, security
guards, and dispatchers found to have
COVID–19 antibodies (29.8 to 37.3%)
were among the highest levels observed
in all the occupations. The study
authors noted that those jobs involve
frequent or close contact with the public
or are done in places where employees
work in close proximity to their
coworkers.
Wallace et al. (May 15, 2020)
evaluated data on COVID–19 cases and
deaths among correctional facility
employees and inmates from January 21
to April 21, 2020. Data were reported to
CDC by 37 (69%) of 54 state and
territorial health department
jurisdictions. Of these 37 jurisdictions,
32 (86%) reported at least one COVID–
19 case from a correctional facility. Of
the 420 facilities with a case, 221 (53%)
reported cases only among staff
members. In total, 4,893 COVID–19
cases among incarcerated or detained
persons and 2,778 cases among staff
members were reported (total tested not
provided). Among staff member cases,
79 hospitalizations (3%) and 15 deaths
(1%) were reported. The study authors
noted that ‘‘correctional and detention
facilities face challenges in controlling
the spread of infectious diseases
because of crowded, shared
environments and potential
introductions by staff members and new
intakes.’’
Ward et al. (June 2021) analyzed
COVID–19 prevalence among prisoners
and staff in 45 states from March 31,
2020 through November 4, 2020. During
that time period, COVID–19 cases in
staff were 3 to 5 times higher compared
to the U.S. population. Average daily
increases in cases were 42 per 100,000
prison employees, 61 per 100,000
prisoners, and 13 per 100,000 U.S.
residents. On November 4, 2020,
COVID–19 prevalence for prison staff
was 9,316 cases per 100,000 employees,
which was 3.2 times greater than
prevalence in the U.S. population (2,900
cases per 100,000).
Kirbiyik et al. (November 6, 2020)
analyzed movement through a network-
informed approach to identify likely
high points of transmission within the
Cook County Jail in Chicago, IL. At that
facility, over 900 COVID–19 cases were
reported across 10 housing divisions in
13 buildings from March 1–April 30,
2020. Staff members were required to
report symptoms of COVID–19
(probable cases) or receipt of a positive
test result (confirmed cases). A total of
2,041 staff members (77% of staff) were
included in the network analysis
because information was available about
their shift and division assignments,
and 198 (9.7%) of those staff members
had COVID–19 during the two-month
study period. Connections between staff
members who had COVID–19 were
higher than expected, suggesting likely
transmission among staff members.
Fewer connections than expected were
observed among detained persons with
SARS–CoV–2 infections, suggesting the
effectiveness of medical isolation at
reducing transmission.
The Officer Down Memorial Page,
which tracks police officer fatalities
determined to be occupationally related,
reported that the majority of officer
deaths for 2021 (157 of 269) were
related to COVID–19 (ODMP, September
14, 2021). For the 269 officers who died,
causes of death were not reported for
each month, but the highest numbers of
monthly deaths, 52 in January and 65 in
August (compared to 16 to 34 deaths on
other reported months), were consistent
with the winter surge of COVID–19 and,
more recently, the surge caused by the
Delta variant.
The risk of COVID–19 has also been
examined in industries where
employees have little contact with the
public, such as construction, and food
processing, and where most exposure to
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SARS–CoV–2 likely comes from other
workers. Pasco et al. (October 29, 2020)
examined the association between
construction work during the COVID–19
pandemic and community transmission
and construction worker hospitalization
rates in Austin, Texas from March 13 to
August 20, 2020. A ‘‘Stay Home-Work
Safe’’ order enacted on March 24, 2020,
limited construction to only critical
infrastructure and excluded commercial
and residential work. One week later,
the Texas governor lifted the restriction
for essential workers and allowed all
types of construction work to resume,
while keeping the order in place for
other workers. The authors found that
resuming construction during the
shelter-in-place order led to an increase
in community transmission, an increase
in hospitalizations among community
members, and an increase in
hospitalizations of construction
workers. By mid-July, Austin Public
Health identified at least 42 clusters (not
defined) of COVID–19 cases in the
construction industry; 515 individuals
were hospitalized for COVID–19
illnesses acquired as part of these
clusters, and 77 of those reported
working in construction. The study
found that construction workers had a
nearly 5-fold increased risk of
hospitalization in central Texas
compared with workers in other
occupations. The authors’ model
predicted that allowing unrestricted
construction work would be associated
with an increase in COVID–19
hospitalization rates from 0.38 per 1,000
residents to 1.5 per 1,000 residents
overall, and from 0.22 per 1,000
construction workers to 9.3 per 1,000
construction workers for the
construction industry specifically. The
authors concluded that stringent
workplace safety measures could
significantly mitigate risks related to
COVID–19 in the industry.
The meat packing and processing
industries and related agricultural and
food processing sectors have also been
impacted by COVID–19. Waltenburg et
al. (January, 2021) reported COVID–19
cases in employees from meat and
poultry processing facilities in 31 states
from March 1 through May 31, 2020. As
reported in Table 2 of that report, 28,364
employees in those facilities were
confirmed to have COVID–19 by
laboratory testing and 132 died. Among
the 20 states that reported total numbers
of employees, 11.4% of the workers
were diagnosed with COVID–19 (with a
range of 3.1 to 27.7% of workers in
individual states). For states that
reported at least one COVID–19-related
death, the percentages of employees
who died in each state ranged from 0.1
to 2.4% of those with COVID–19. The
authors found a high burden of disease
in persons employed at these facilities
who were racial or ethnic minorities.
Higher incidence in these populations
might be due to the likelihood of these
employees working in areas in the plant
where transmission risk is higher.
Steinberg et al. (August 7, 2020)
reported that attack rates (i.e., the
number of individuals who are infected
in comparison to the total number at
risk) among production employees in
the Cut (30.2%), Conversion (30.1%),
and Harvest (29.4%) departments of a
meat processing plant (where spacing
between employees is less than 6 feet)
were double that of salaried employees
(14.8%) whose workstations had been
modified to increase physical distancing
from others.
Waltenburg et al. (January, 2021) also
evaluated COVID–19 incidence in food
manufacturing and agricultural settings
(e.g., manufacturing or farming
involving fruits, vegetables, dairy, baked
goods, eggs, prepared foods), as reported
in 30 states from March through May
2020. In food manufacturing and
farming of fruits, vegetables, dairy, and
other items, 742 workplaces were
affected, including 8,978 infections and
55 fatalities. For states that reported
total numbers of employees, the
proportion of employees who developed
COVID–19 in each state ranged from 2.0
to 43.5%. For states that reported at
least one death, the percentages of
deaths among cases ranged from 0.1 to
3.8%.
Porter et al. (April 30, 2021) reported
that 13 COVID–19 outbreaks occurred at
Alaska seafood processing facilities and
vessels (both of which were described as
high density workplaces) during the
Summer and early Fall of 2020. The 13
outbreaks involved 539 COVID–19
cases, with 2–168 cases per outbreak.
Attack rates in facilities and offshore
vessels ranged from less than 5% to
75%. Outbreaks were also reported in
entry quarantine groups. Because of
these outbreaks, it was determined that
vaccination of these essential workers is
important and requirements for COVID–
19 prevention were updated to include
smaller quarantine groups, serial testing,
and testing before transfers from one
facility or vessel to another.
Finally, two published studies
analyzed death records to determine
how mortality rates among individuals
in various types of workplaces had
changed during the pandemic. Chen et
al. (June 4, 2021) analyzed records of
deaths occurring on or after January 1,
2016 in California and found that
mortality rates in working aged adults
(18–65 years) increased 22% during the
COVID–19 pandemic period of March
through November 2020 compared to
pre-pandemic periods. Relative to pre-
pandemic periods, the groups of
employees experiencing the highest,
statistically significant increases in
relative excess mortality were those in
food/agriculture (39% increase),
transportation/logistics (31% increase),
facilities (23% increase), and
manufacturing (24% increase). Other
groups that also experienced excess,
statistically significant mortality
compared to pre-pandemic periods were
health or emergency workers (17%
increase), retail workers (21% increase),
and government and community
workers (17% increase). The study
authors concluded that certain
occupational sectors were impacted
disproportionally by mortality during
the pandemic and that essential work
conducted in-person is a likely avenue
of infection transmission.
Hawkins et al. (January 10, 2021)
examined death certificates of
individuals who died in Massachusetts
between March 1 and July 31, 2020. An
age-adjusted mortality rate of 16.4 per
100,000 employees was determined
from 555 death certificates that had
useable occupation information.
Employees in 11 occupational groups
had particularly high mortality rates:
healthcare support; transportation and
material moving; food preparation and
serving; building and grounds cleaning
and maintenance; production,
construction and extraction;
installation/maintenance/repair;
protective services; personal care
services; arts/design/entertainment;
sports/media; and community and
social services. The study authors noted
that occupational groups expected to
have frequent contact with sick people,
close contact with the public, and jobs
that are not practical to do from home
had particularly elevated mortality
rates.
b. Healthcare Workers
As explained in the Healthcare ETS,
COVID–19 presents a grave danger to
workers in all U.S. healthcare settings
where people with COVID–19 are
reasonably expected to be present (86
FR 32381). Healthcare settings covered
by the Healthcare ETS primarily include
settings where people with suspected or
confirmed COVID–19 are treated,
exacerbating the risk present in most
workplaces. To control the higher level
of risk in those settings, OSHA
determined that a suite of workplace
controls was necessary to protect all
employees, whether they are vaccinated
or unvaccinated. As explained further
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below, OSHA now finds that
unvaccinated healthcare workers in
healthcare settings not covered by the
Healthcare ETS are also at grave danger
from exposure to SARS–CoV–2, just like
unvaccinated workers in other
industries. Data continue to be collected
and reported for healthcare workers,
and a small number of peer-reviewed
studies demonstrate the potential
impact of the Delta variant on
healthcare workers.
CDC continues to provide updates for
COVID–19 cases and deaths among
healthcare personnel. However,
information on healthcare personnel
status continues to be reported for only
a fraction (18.91%) of total reported
cases, and death status was reported for
only 82.16% of healthcare personnel
cases as of October 18, 2021 (CDC,
October 18, 2021—Healthcare
Personnel). Given incomplete reporting,
the data from this source represent only
a fraction of actual healthcare cases and
deaths. Nevertheless, CDC reported
666,707 healthcare personnel cases
among the 6,754,306 reported cases that
included information on healthcare
personnel status (9.9%) and 2,229
fatalities among the 547,769 cases that
included death status (0.4%) for
healthcare employees as of October 18,
2021. This is a 26% increase in the
number of cases and a 27% increase in
the number of deaths since the May 24,
2021 data reported in the ETS (CDC,
October 18, 2021—Healthcare
Personnel). The Delta variant is likely
responsible for the majority of those
deaths. No healthcare worker deaths
were reported by CDC during the weeks
of May 30 through June 13, 2021;
however, as the Delta variant’s
prevalence rose after June 20, healthcare
worker deaths began increasing; they
peaked during the period of August 15
through September 12, 2021, when 34 to
36 healthcare worker deaths were
reported per week (CDC October 18,
2021—Healthcare Personnel, Deaths by
Week). Independent reporting by Kaiser
Health News and The Guardian reported
more than 3,600 fatalities in health care
workers as of April 2021 (Spencer and
Jewett, April 8, 2021). That number is
expected to be higher at this time since
the earlier figure did not include the
most recent 5 months of the pandemic,
which includes the period of Delta
variant predominance.
Published studies also demonstrate
that healthcare workers, especially those
who are unvaccinated, remain at risk of
being infected with SARS–CoV–2 (see
Section III.A.IV. Vaccines Effectively
Reduce Severe Health Outcomes from
and Transmission of SARS–CoV–2).
Routine testing of health care personnel,
first responders, and other frontline
workers in eight U.S. locations in six
states from December 14, 2020 through
August 14, 2021 revealed 194 infections
in 4,136 unvaccinated participants
(89.7% symptomatic) and 34 infections
in 2,976 fully vaccinated participants
(80.6% symptomatic) (Fowlkes et al.,
August 27, 2021). During time periods
when the Delta variant represented
more than 50% of viruses sequenced, 19
infections were detected in 488
unvaccinated participants (94.7%
symptomatic) and 24 infections were
detected in 2,352 vaccinated
participants (75% symptomatic).
Monthly COVID–19 cases in
healthcare workers were reported
during the period from March 1 to July
31, 2021 at the University of California
San Diego (UCSD) health system, which
is a healthcare provider that includes
primary care services such as family
medicine and pediatrics (Keehner et al.,
September 1, 2021; UCSD, 2021). During
that time period, a total of 227 health
care workers tested positive for COVID–
19. One hundred and nine of 130 fully
vaccinated workers who tested positive
(83.8%) were symptomatic and 80 of 90
unvaccinated workers (88.9%) were
symptomatic; one unvaccinated person
was hospitalized for COVID–19
symptoms. By July of 2021, after the end
of California’s mask mandate on June 15
and after the Delta variant became
dominant, the number of cases detected
dramatically increased; the Delta variant
accounted for more than 95% of SARS–
CoV–2 viruses sequenced by the end of
that month. During July of 2021,
symptomatic infections were detected in
94 of 16,492 fully vaccinated workers
and 31 of 1,895 unvaccinated workers.
Attack rates in July of 2021 were 5.7 per
1,000 fully vaccinated workers and 16.4
per 1,000 unvaccinated workers.
In Finland, a Delta variant infection
from a hospitalized patient spread
throughout the hospital and to three
primary care facilities, infecting 103
individuals, including 45 healthcare
workers (Hetema¨ki et al., July 29, 2021).
Twenty-six of the healthcare workers
were infected at the hospital and 19
were infected at primary care facilities.
The affected health care workers
included 28 with direct patient contact
(11 who were not fully vaccinated), 8
unvaccinated healthcare worker
students, and 9 other staff, including
hospital cleaners and secretaries (of
whom 6 were not fully vaccinated).
According to study authors, ‘‘There was
high vaccine coverage among permanent
staff in the central hospital, but lower
for HCW in primary healthcare
facilities. . .’’ Study authors estimated
that vaccine effectiveness against the
Delta variant in healthcare workers was
approximately 88–91%, suggesting how
much more extensive the outbreak
could have been if a high percentage of
healthcare workers were not fully
vaccinated.
In the UK, a Delta variant infection in
a healthcare worker resulted in an
outbreak in a care home that affected 16
of 21 residents and 8 of 21 staff
(Williams et al., July 8, 2021). One staff
member was hospitalized. Attack rates
were 35.7% in staff who were partially
vaccinated (i.e., received their second
dose of vaccine on the day that the
index case was diagnosed with COVID–
19 or had only received one vaccine
dose) and 40% in staff who were not
vaccinated.
Recent news stories demonstrate that
outbreaks affecting staff members are
still occurring in U.S. healthcare
facilities. An outbreak that began in
August, 2021 at a Washington State
nursing center resulted in infections in
22 staff members and 52 residents. In an
unrelated outbreak, a nursing facility in
Hawaii reported infections in 24
employees and 54 patients (Wingate,
September 24, 2021). Vaccination rates
were reported at 64.5% of residents and
37.1% of staff in the Washington State
facility and 91% of staff and more than
80% of patients at the Hawaii facility.
COVID–19 cases were also observed
in staff at ambulatory care settings prior
to emergence of the Delta variant. Over
an 11-week period beginning on March
20, 2020, 254 tests for SARS–CoV–2
were performed on employees who had
potential exposures at an outpatient
urology center in New York State
(Kapoor et al., 2020). Positive test rates
in employees correlated with rates in
New York State, declining over time,
from 26.1% in the early stage to 7.3%
in the late stage of the study. According
to study authors, the positive test results
coincided with the implementation of
infection control procedures (e.g.,
symptom screening, masking,
distancing, and hygiene). Positivity rates
were similar in administrative and
clinical staff and the study authors
concluded that ‘‘administrative staff in
an outpatient setting were equally—if
not more—vulnerable to SARS–CoV–2
transmission when compared with
clinical staff who were more directly
exposed to patients.’’ The study authors
speculated that possible reasons for the
findings were that clinical staff were
more familiar with PPE and that
administrative staff, especially in check-
in and check-out points, tend to work
close to each other.
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12 A discussion of vaccination rates, as well as
OSHA’s rationale for why vaccination is a critical
means of protecting workers from the grave danger
described in this section, can be found in Need for
the ETS (Section III.B. of this preamble).
13 While mild cases of COVID–19 are included in
the grave danger presented by COVID–19, as stated
in the Healthcare ETS (see 86 FR 32382), OSHA is
focusing on the most severe health effects, i.e., cases
requiring hospitalization and cases resulting in
death, in this new rulemaking effort in order to
prevent the gravest of consequences to workers.
14 This adoption includes the citations in the
referenced section of the Healthcare ETS, which are
also included in the docket for this ETS.
c. Conclusion for Employee Impact
The evidence described above
provides examples of the impact that
exposures from SARS–CoV–2, including
those involving the Delta variant, have
had on employees in general industry,
agriculture, construction, maritime, and
healthcare settings. It demonstrates that
SARS–CoV–2 has spread to employees
in these industries and, in many cases,
infection was linked to exposure to
infected persons at the worksite (WSDH,
September 8, 2021; OHA, September 1,
2021; TDH, September 8, 2021;
NCDHHS, August 30, 2021; Hawaii
State, August 19, 2021; Pray et al.,
January 29, 2021; Sami et al., April 9,
2021; Suhs et al., July 23, 2021; Gold et
al., February 26, 2021; Porter et al.,
April 30, 2021; Hetema¨ki et al., July 29,
2021; Williams et al., July 8, 2021). The
documentation of so many workplace
clusters suggests that exposures to
SARS–CoV–2 occur regularly in
workplaces where employees come into
contact with others. This prevalence of
clusters, combined with some evidence
that many infections occurred within
the 14-day incubation period for SARS–
CoV–2 and that exposures to infected
persons outside the workplace were
frequently ruled out, supports the
proposition that exposures to and
transmission of SARS–CoV–2 occur
frequently at work. Multiple studies
demonstrate high rates of COVID
infections, illnesses, and fatalities in the
wide range of occupations that require
frequent or prolonged close contact with
other people, indoor work, and work in
crowded and/or poorly ventilated areas
The large numbers of infected
employees suggest that SARS–CoV–2 is
likely to be present in a wide variety of
workplaces, placing unvaccinated
workers at risk of serious and
potentially fatal health effects.
IV. Vaccines Effectively Reduce Severe
Health Outcomes From and
Transmission of SARS–CoV–2
During the course of the SARS–CoV–
2 pandemic, different variants have
emerged with different characteristics
that better enable transmission and
potentially cause more severe outcomes.
However, vaccines remain very effective
at reducing the occurrence of COVID–
19-related severe illness, disability and
death.12 The Delta variant is more
transmissible than previous variants,
might cause more severe illness than
previous variants in unvaccinated
people, and has led to hospitalization of
individuals in numbers similar to those
of the November 2020 to February 2021
surge. These changes in characteristics
have provided a clearer realization of
the continuing capacity for SARS–CoV–
2 to present a grave danger to workers.
However, it is well evident that even
given these changed characteristics of
Delta, serious disease and death
continue to occur overwhelmingly in
unvaccinated individuals while the
vaccinated are afforded great
protection.13
a. Impact of Vaccination on Severe
Health Outcomes
There are currently three vaccines
that are approved or authorized for the
prevention of COVID–19 in the U.S.:
The Pfizer-BioNTech COVID–19 vaccine
(FDA approved for ages 16 and above;
authorized for ages 12 and above), the
FDA-authorized Moderna COVID–19
vaccine (authorized for ages 18 and
above), and the FDA-authorized Janssen
COVID–19 vaccine (also known as the
Johnson & Johnson vaccine; authorized
for ages 18 and above.) Pfizer-BioNTech
and Moderna are mRNA vaccines that
require two primary series doses
administered three weeks and one
month apart, respectively. Janssen is a
viral vector vaccine administered as a
single primary vaccination dose (CDC,
September 15, 2021). The vaccines were
shown to greatly exceed minimum
efficacy thresholds in preventing
COVID–19 in clinical trial participants
(FDA, December 11, 2020; FDA,
December 18, 2020; FDA, February 26,
2021). Data from clinical trials for all
three vaccines and observational studies
for the two mRNA vaccines clearly
establish that fully vaccinated persons
have a greatly reduced risk of SARS–
CoV–2 infection compared to
unvaccinated individuals. This includes
severe infections requiring
hospitalization and those resulting in
death. For more information about the
effectiveness of vaccines as of late
Spring 2021, see 86 FR 32397, which
OSHA hereby includes in the record for
this ETS.14
Vaccines remain highly effective
against hospitalization and death. A
study evaluating vaccine effectiveness at
preventing hospitalization among those
with SARS–CoV–2 infections in New
York found that effectiveness did not
change from May 3 to July 25, 2021 as
the Alpha variant gave way to the Delta
variant (91.9–96.2% range; Rosenberg et
al., August 27, 2021). Grannis et al. used
data from 187 hospitals in nine states
from June to August 2021 to evaluate
the efficacy of vaccines against
hospitalization when Delta had emerged
as the predominant variant causing
SARS–CoV–2 infections (September 17,
2021). This study found that vaccines
were 89% effective at preventing
hospitalization in individuals aged 18 to
74. Similarly, vaccines were also found
to be 89% effective in preventing
hospitalization in a study collecting
data from five Veteran Affairs Medical
Centers from July 1 to August 6, 2021,
a time when most transmission was
attributed to the Delta variant (Bajema et
al., September 10, 2021).
Two other studies found that,
although the level of protection
provided by vaccination has decreased
somewhat with the emergence of the
Delta variant, vaccines continue to
provide high levels of protection against
hospitalization. In a U.S. study,
researchers found that while the
Moderna and Janssen vaccines mostly
maintained their effectiveness at
preventing hospitalization (going from
93% to 92% after more than 120 days
post-vaccination and 71% to 68% after
more than 28 days post-vaccination,
respectively) from March to August
2021, the effectiveness of the Pfizer-
BioNTech vaccine at preventing those
severe outcomes decreased from 91% to
77% after more than 120 days post-
vaccination (Self et al., September 17,
2021). An Israeli study on infections
documented between July 11 and July
31, 2021 found a significant decrease in
vaccine efficacy for the Pfizer-BioNTech
vaccine against severe outcomes in
relation to when an individual was
vaccinated, but the absolute difference
was much less than what was observed
in the U.S. study (e.g., 98% effective for
40–59 year olds vaccinated in March
versus 94% effective for those in the
same age group who were vaccinated in
January) (Goldberg et al., August 30,
2021).
Vaccines also remain extremely
effective at preventing death. A UK
study evaluated the effectiveness of the
Pfizer-BioNTech vaccine against death
and found it to be 96.3% effective
against the Alpha strain and 95.2%
protective against the Delta strain
(Andrews et al., September 21, 2021).
Two Israeli studies, Haas et al. and
Saciuk et al., performed during time
periods where Alpha was predominant,
found the Pfizer-BioNTech vaccine to be
96.7% and 91.1% effective,
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respectively, against death (Haas et al.,
May 15, 2021; Saciuk et al., June 25,
2021). A California study found that the
Moderna vaccine was 97.9% effective
against death (Bruxvoort et al.,
September 2, 2021). A study on patients
served by the Veterans Health
Administration found that Pfizer-
BioNTech and Moderna vaccines
provided 99% effectiveness against
death (Young-Xu et al., July 14, 2021).
The risks of hospitalization and death
appear to have increased for
unvaccinated individuals since the
Delta variant became a common source
of infections. A study of Los Angeles
County SARS–CoV–2 infections found
that vaccinations reduced
hospitalization risk by a factor of 10 on
May 1, 2021, when the Alpha variant
was dominant, but that the risk of
hospitalization was even more greatly
reduced (by a factor of 29.2) on July 25,
2021, when the Delta variant was
dominant (Griffin et al., August 27,
2021). This difference suggests both that
vaccines continue to provide a high
level of protection against disease that
results in hospitalization and that risk
has increased for those who are
unvaccinated. Similar increased risk for
unvaccinated individuals was reported
in a study that evaluated hospitalization
and death data from 13 U.S.
jurisdictions between June 20 and July
17, 2021, a period when the Delta
variant gained prominence (Scobie et
al., September 17, 2021). For
unvaccinated 18 to 49 year olds, the risk
of hospitalization was 15.2 times
greater, and the risk of death was 17.2
times greater, than the risks for
vaccinated people in the same age
range. For unvaccinated 50 to 64 year
olds, the risk of hospitalization was 10.9
times greater, and the risk of death was
17.9 times greater, than for those who
are vaccinated. These studies illustrate
that vaccination is an extremely
effective control measure to minimize
severe outcomes resulting from Delta
variant infections.
b. Impact of Vaccination on Infection
and Transmission
Vaccines continue to provide robust
protection for vaccinated individuals
against SARS–CoV–2 infections, even
though several studies indicate that
vaccine efficacy against infection may
have decreased somewhat with the
emergence of the Delta variant (Fowlkes
et al., August 27, 2021; Rosenberg et al.,
August 27, 2021; Nanduri et al., August
27, 2021; Seppala et al., September 2,
2021; Bernal et al., August 12, 2021).
For example, vaccination was observed
to reduce the risk of infection by a factor
of 8.4 on May 1, 2021, when the Alpha
variant was predominant in Los Angeles
county (Griffin et al., August 27, 2021).
However, the level of protection had
fallen to a factor of 4.9 by July 25, 2021,
when Delta made up 88% of infections
in the county. The findings from this
study indicate that while vaccines
maintain robust protection against
severe outcomes, protection against
infection has fallen with the increased
circulation of the Delta variant. A
broader study using data from 13 U.S.
jurisdictions had similar findings,
observing that the protection vaccines
afforded against infection decreased
from a factor of 11.1 (i.e., vaccinated
people were 11.1 times less likely than
unvaccinated people to become
infected) between April 4 and June 19,
2021, to a factor of 4.6 between June 20
and July 17, 2021 (Scobie et al.,
September 17, 2021). An additional
study noted, however, that the decrease
in vaccine protectiveness against
symptomatic infection from the Delta
variant could be due to the waning of
immunity specifically in older
populations. Andrews et al. (September
21, 2021) found that while the Pfizer-
BioNTech vaccine effectiveness
decreased from 94.1% to 67.4% in those
65 years old and older, vaccine
effectiveness for those 40 to 64 years old
only decreased from 92.9% to 80.6%.
While infections themselves do not
normally result in serious illness for
those who are vaccinated, evidence
shows that vaccinated individuals who
become infected with the Delta variant
can transmit the disease more easily to
others than with previous variants. This
development poses a great concern for
the unvaccinated, who generally do not
have the protections against severe
outcomes that vaccination affords.
Before Delta, vaccinated individuals
were shown to have lower estimated
viral loads when infected than those
who were unvaccinated, which
suggested that infected vaccinated
individuals were likely not a major
concern for transmission (Levine-
Tiefenbrun et al., March 29, 2021).
Transmission studies prior to the
emergence of Delta appear to bear this
out. A Scottish study performed during
a time period when the Alpha variant
was predominant in the region, showed
that a fully vaccinated individual was
3.2 times less likely than an
unvaccinated individual to transmit the
virus to unvaccinated family members
(Shah et al., September 10, 2021;
supplementary appendix). A
population-based study from the
Netherlands found that vaccination
decreased secondary transmission to
household members from 31% to 11%
(de Gier et al., August 5, 2021).
Additionally, a study from the UK
found that household transmission
decreased by as much as 50% when the
infected individual was vaccinated
(Harris et al., June 23, 2021).
More recent research suggests that the
Delta variant may have reduced the
level of protection vaccination affords
against transmission of the virus to
others, but still significantly reduces
transmission risk in comparison to
infected unvaccinated individuals. A
UK study found that fully vaccinated
individuals infected by the Delta variant
are able to transmit the virus to both
vaccinated and, to a greater degree,
unvaccinated persons (Singanayagam et
al., September 6, 2021). Still, the rate at
which transmission to unvaccinated
individuals occurred was nearly double
the rate of transmission to vaccinated
individuals (35.7% compared to 19.7%).
Similarly, Eyre et al., (September 29,
2021) found that during the
predominance of Alpha, full vaccination
with the Pfizer-BioNTech vaccines
resulted in a significant reduction in
transmission to others (an adjusted
Odds Ratio (aOR) of 0.18, meaning that
being unvaccinated increased the odds
of transmission by over five times). With
the rise of the Delta variant, that
reduction in transmission to others was
less than with the Alpha variant, but
still significantly more than for
unvaccinated individuals (aOR of 0.35,
meaning that being unvaccinated
increased the odds of transmission by
almost three times).
The greater ability for vaccinated
individuals to transmit the Delta variant
of SARS–CoV–2 to others (compared to
previous variants) appears to be linked
to the generation of similar viral loads
(as estimated by Ct threshold) in the
vaccinated compared to the
unvaccinated (Ct threshold is the
number of RT–PCR cycles that need to
be run in order to amplify the RNA
enough to be detected—fewer cycles
means a greater initial amount of virus
was collected) (Singanayagam et al.,
September 6, 2021). This observation
has been made in several studies. A
study from Israel observed that viral
loads among those infected with the
Delta variant were only decreased in
people who had been vaccinated
recently (within the past two months) or
in those who had recently received a
booster dose (Levine-Tiefenbrun et al.,
September 1, 2021). In a study of SARS–
CoV–2 infections in Los Angeles
County, performed when the Delta
variant was predominant, vaccination
status did not appear to affect the
estimated viral loads, suggesting that
infected individuals who are vaccinated
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15 The exclusion of vaccinated workers from this
grave danger finding does not mean that vaccinated
workers face no risk from exposure to SARS–CoV–
2. The best available evidence clearly shows that
vaccination provides great protection from infection
and severe outcomes, but breakthrough infections
do occur and vaccinated individuals can still
transmit the virus to others. In some cases, the level
of risk to vaccinated workers may even rise to the
level of a significant risk, the standard OSHA must
meet for promulgation of a permanent standard
under section 6(b)(5) of the OSH Act (29 U.S.C.
655(b)(5)).
may be just as likely to transmit the
virus (Griffin et al., August 27, 2021).
Additionally, estimated viral loads did
not appear to be significantly different
with respect to vaccination status in a
Wisconsin study (Riemersma et al., July
31, 2021). Regardless of viral loads in
vaccinated and unvaccinated
individuals, the fact remains clear that
unvaccinated people pose a higher risk
of transmission to others than
vaccinated people, simply because they
are much more likely to get COVID–19
in the first place.
These studies, however, appear to
overstate increases in transmission risk
from vaccinated individuals related to
the Delta variant. From May to July
2021, UK researchers tested individuals
at random to better characterize viral
load estimates in people with
asymptomatic as well as symptomatic
infections; they found that vaccination
was associated with a significantly
lower estimated viral load (Elliott et al.,
September 10, 2021). This more
comprehensive study (i.e., Elliott et al.,
September 10, 2021) may have been able
to better characterize the course of
infection and to incorporate vaccinated
individuals whose viral loads were
decreasing quickly. The findings in
Elliott et al. are consistent with studies
observing that viral load may fall more
quickly in vaccinated individuals,
resulting in a shorter infectious period
and possibly fewer transmission events
(Chia et al., July 31, 2021; Eyre et al.,
September 29, 2021).
c. Conclusion for the Impact of Vaccines
The studies discussed above indicate
that vaccines continue to effectively
protect vaccinated individuals against
SARS–CoV–2 infections, while the risk
of infection, hospitalization, and death
increased among unvaccinated people
as the Delta variant became
predominant in the U.S. The Delta
variant is even more dangerous to
unvaccinated individuals than previous
variants because of the higher
transmission potential from both
unvaccinated and vaccinated people.
Because unvaccinated individuals are at
much higher risk of severe health
outcomes from infection with SARS–
CoV–2, and also pose a greater
transmission risk to those around them,
it is critical to assure that as many
people as possible are fully vaccinated
in order to prevent transmission at
work.
V. Coverage of OSHA’s Grave Danger
Finding
Based on the information discussed
above, OSHA finds that many
unvaccinated workers across the U.S.
economy are facing a grave danger of
severe health effects or death from
exposure to SARS–CoV–2. Fully
vaccinated workers are not included in
this grave danger finding because, as
described throughout this section, those
who are fully vaccinated are much
better protected from the effects of
SARS–CoV–2 and, in particular, the
most severe effects, than are those who
are unvaccinated.15 Beyond that,
OSHA’s grave danger determination
exempts several categories of workers
based on characteristics of their work or
workplace: (1) Workers who do not
report to a workplace where other
individuals are present or who telework
from home; and (2) workers who
perform their work exclusively
outdoors. The basis for these
exemptions is explained below. In this
section, OSHA also addresses the basis
for OSHA’s grave danger finding for
workers who are unvaccinated yet had
a prior COVID–19 infection, and
explains the Agency’s more nuanced
grave danger finding in the healthcare
industry.
a. Employees Who Telework and
Employees Who Do Not Report to a
Workplace Where Other People Are
Present.
Employees who report to workplaces
where no other people are present face
no grave danger from occupational
exposure to COVID–19 because such
exposure requires the presence of other
people. For those who work from their
homes, or from workplaces where no
other people are present (such as a
remote worksite), the chances of being
exposed to SARS–CoV–2 through a
work activity are negligible. Therefore,
OSHA is exempting those workers who
do not come into contact with others for
work purposes from its grave danger
finding as well as the scope of the ETS
(for more information, see the Summary
and Explanation for Scope and
Application, Section VI.B. of this
preamble).
b. Employees Who Work Exclusively
Outside
Employees who work exclusively
outside face a much lower risk of
exposure to SARS–CoV–2 at work,
because their workplaces typically do
not include any of the characteristics
that normally enable transmission to
occur (e.g., indoors, lack of ventilation,
crowding). Bulfone et al. attributed the
lower risk of transmission in outdoor
settings (i.e., open air or structures with
one wall) to increased ventilation with
fresh air and a greater ability to
maintain physical distancing (November
29, 2020). While the best available
evidence firmly establishes a grave
danger in indoor settings, the CDC has
stated that the risk of outdoor
transmission is ‘‘low’’ (CDC, September
1, 2021) and OSHA is unable to
establish a grave danger in outdoor
settings from exposure during normal
work activities.
OSHA recognizes that outdoor
transmission has been identified in a
few specific incidents (e.g., 2 of 7,324
cases, Qian et al., October 27, 2020).
However, general reviews of
transmission studies that include large-
scale and high-density outdoor
gatherings indicate that indoor
transmission overwhelmingly is
responsible for SARS–CoV–2
transmission. Additionally, the lack of
evidence tied to specific case studies
illustrating outdoor transmission in
comparison to the bevy of case studies
on indoor transmission makes it
difficult to support a conclusion that
outdoor transmission rises to the level
of a grave danger.
Bulfone et al. reviewed a collection of
SARS–CoV–2 studies that evaluated
infections in outdoor and indoor
settings (November 29, 2020), and found
that transmission is significantly less
likely to occur in outdoor settings than
in indoor settings. The studies overall
found that the risk of outdoor
transmission was less than 10% of the
risk of transmission in indoor settings,
with three of the studies concluding risk
was 5% or less of the risk of
transmission in indoor settings. While
acknowledging significant gaps in
knowledge, the authors of a different
study suggested that increases in
transmission related to large events such
as the Sturgis motorcycle rally may be
related to lack of local efforts to prevent
transmission indoors (e.g., requiring the
wearing of masks, closing indoor
dining), rather than the outdoor setting
for the rally (Dave et al., December 2,
2020). In contrast, transmission rates
did not increase as expected following
the Summer 2020 protests on racial
injustice. This outcome was attributed,
in part, to participants having been less
likely to enter indoor commercial
establishments.
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Weed and Foad (September 10, 2020)
found that transmission of SARS–CoV–
2 related to large scale outdoor
gatherings could be largely attributed to
individual behaviors related to that
event, such as communal travel and
indoor congregation at other facilities
(e.g., restaurants, shared
accommodations), rather than to the
time spent outdoors at those gatherings.
Similarly, a Public Health England
evaluation of the literature on SARS–
CoV–2 and surrogate respiratory viruses
(December 18, 2020) also concluded that
when transmission does occur at
outdoor events, outdoor activities were
mixed with indoor setting use. Public
Health England concluded that the vast
majority of transmission happens in
indoor settings, with very little evidence
for outdoor transmission.
A systemic review of SARS–CoV–2
clusters identified 201 events through
May 26, 2020 (Leclerc et al., April 28,
2021), only 4 of which occurred at
predominantly outdoor settings. For
those 4 clusters, the authors noted that
they were not able to evaluate specific
transmission events and attributed it to
local health agencies being
overwhelmed by the pandemic. OSHA
notes that the designations of settings in
this study are somewhat generic, as
outdoor construction sites will often
have indoor locations, such as mobile
offices, or locations with reduced
airflow, such as areas with a roof or
ceiling and two or more walls.
Regardless, this study illustrates the
comparable abundance of evidence
available to evaluate SARS–CoV–2
transmission in indoor settings versus
outdoor settings.
Cevik et al. (August 1, 2021) reviewed
studies on the transmission dynamics of
SARS–CoV–2 infections from large
scale, contact-tracing studies. The
authors recommended that, based on the
evidence that outdoor transmission
dynamics resulted in significantly fewer
infections than in indoor settings,
public health entities should greatly
encourage use of outdoor settings. The
researchers highlighted a study by
Nishiura et al. (April 16, 2020), who
evaluated 110 cases in Japan at the
beginning of the pandemic and found
that outdoor settings reduced
transmission risk by 18.7 times and
reduced the risk of super-spreader
events by 32.5 times.
Agricultural workplace settings have
experienced significant SARS–CoV–2
infections. However, transmission in
these settings is difficult to characterize
because many jobs in this sector include
both outdoor and indoor activities.
Miller et al. (April 30, 2021) evaluated
an outbreak among farmworkers in
Washington State. The researchers
found that 28% of workers with
predominantly indoor tasks where they
were unable to maintain physical
distance were infected, compared to 6%
of workers who performed
predominantly outdoors tasks in the
orchards. Conversely, a study on
farmworkers in Monterey County,
California found a significant
correlation between evidence of
infection and individuals who worked
in the fields as opposed to indoor work
(Mora et al., September 15, 2021). The
paper noted that infections were
predominant in individuals who lived
in crowded conditions, commuted
together to the fields, and spoke at home
in indigenous languages, which is
important as written health messages
are often not available in all worker
languages. These papers cannot identify
where or when infections occurred in
order to discern causation. The
associations observed may indicate that
SARS–CoV–2 infections may be more
related to aspects related to indoor
exposures outside of the work activities
(e.g., crowded living conditions) or
potentially overlooked indoor aspects
connected to outdoor work (e.g., shared
commuting).
Several studies discussed below in
more detail have evaluated outdoors on-
field transmission from infected
participants during football, soccer, and
rugby matches. These events include
repeated close physical contact between
players, without PPE or physical
distancing, over the course of fairly long
events, with increased exertion leading
to greater respiratory effort and
production of respiratory droplets.
These events also include opposing
cohorts who only interact during on-
field activities. Therefore, these studies
provide some evidence for the low
likelihood of outdoor transmission in
other workplace activities greatly
impacted by the pandemic, such as in
construction.
Mack et al. (January 29, 2021) detailed
the National Football League’s complex
program to assess and prevent
transmission, which included devices
that recorded distance and duration of
interactions with others, for the purpose
of improving identification of
individuals with high-risk exposures.
Although 329 positive cases were
identified among roughly 11,400 players
and staff, there were no reported cases
of on-field transmission by infected
players. The results led the NFL to focus
more on reducing transmission in
indoor settings, including
transportation.
Egger et al. (March 18, 2021) reviewed
three soccer matches involving 18
players who had SARS–CoV–2; one
match involved a team where 44% of
the players were infected. Video
analysis was used to determine the type
of contact between players, such as
contact to face or hand slaps. None of
the existing cases were associated with
on-field play and no secondary
transmission from on-the-field contacts
was observed. Jones et al. (February 11,
2021), evaluated four rugby Super
League matches involving eight players
who were found to be infected with
SARS–CoV–2. Using video footage and
global positioning data, the researchers
were able to identify 28 players as high-
risk contacts with the infected players.
These high-risk players together had as
many as 32 tackles and were within two
meters of infected players as often as
121 times during the four matches. Of
the 28 players noted as high-risk
contacts, one became infected with
SARS–CoV–2. However, researchers
determined that the transmission
resulted from internal team outbreaks
and not from exposure on the field.
OSHA acknowledges that the risk of
transmission of SARS–CoV–2 in
outdoor settings is not zero, and that
there may be some low risk to workers
performing general tasks exclusively in
outdoor settings. However, where
studies have been able to differentiate
between indoor and outdoor exposures,
they indicate that indoor exposures are
the much more significant drivers of
SARS–CoV–2 infections. Therefore, the
best available evidence at this time does
not provide OSHA with the information
needed to establish SARS–CoV–2 as a
grave danger for general work activities
in outdoor settings (see Int’l Union,
United Auto., Aerospace, & Agr.
Implement Workers of Am., UAW, 590
F. Supp. at 755–56, describing a ‘‘grave
danger’’ as a risk that is more than
‘‘significant’’). Therefore, OSHA has
excluded employees who work
exclusively outdoors from the scope of
this ETS (see the Summary and
Explanation for Scope and Application,
Section VI.B. of this preamble).
c. Employees in Healthcare
Because OSHA issued a separate
grave danger determination several
months ago for some healthcare
workers, some explanation of how its
current finding applies to healthcare
workers is necessary. In June 2021,
OSHA issued its Healthcare ETS (86 FR
32376) after determining that some
healthcare workers faced a grave danger
of infection from SARS–CoV–2. This
grave danger determination, along with
the protections of the Healthcare ETS,
applied to healthcare and healthcare
support workers in settings where
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people with suspected or confirmed
cases of COVID–19 are treated, and was
based on the increased potential for
transmission of the virus in such
settings (see 86 FR 32411–32412). These
workers are currently covered by the
protections of the Healthcare ETS (29
CFR 1910.502). OSHA does not have
data to demonstrate that unvaccinated
workers in settings covered by the
Healthcare ETS face a grave danger from
SARS–CoV–2 when the requirements of
that standard are followed. However, if
the Healthcare ETS were no longer in
effect, OSHA would consider the
workers who were covered by it, and
who remain unvaccinated, to be at grave
danger for the reasons described in this
ETS.
OSHA’s new finding of grave danger
applies to healthcare and healthcare
support workers who are not covered by
the Healthcare ETS, to the extent they
remain unvaccinated. In this ETS, as
discussed in this section, OSHA has
made a broader determination of grave
danger that applies to most
unvaccinated workers, regardless of
industry. OSHA’s current finding of
grave danger supporting this ETS does
not depend on whether a workplace is
one where people with suspected or
confirmed COVID–19 are expected to be
present. Therefore, the finding of grave
danger applies to unvaccinated workers
in healthcare settings that are not
covered by 29 CFR 1910.502 to the same
extent it applies to unvaccinated
workers in all other industry sectors.
d. Employees Who Were Previously
Infected With SARS–CoV–2
OSHA has carefully evaluated the
effectiveness of previous SARS–CoV–2
infections in providing protection
against reinfection. This section
provides a detailed description of the
current scientific information in order to
ascertain what the best available
scientific evidence on this topic
indicates regarding the risk to
individuals with previous COVID–19
infections from exposure to SARS–CoV–
2. While the agency acknowledges that
the science is evolving, OSHA finds that
there is insufficient evidence to allow
the agency to consider infection-
acquired immunity to allay the grave
danger of exposure to, and reinfection
from, SARS–CoV–2.
To determine whether employees
with infection-induced immunity from
SARS–CoV–2 (i.e., those who were
infected with SARS–CoV–2 but have not
been vaccinated) face a grave danger,
OSHA reviewed the scientific evidence
on the protective effects of vaccine-
induced SARS–CoV–2 immunity versus
infection-induced immunity. Individual
immunity to any infectious disease,
including SARS–CoV–2, is achieved
through a complex response to exposure
by the immune system. This response
consists of disease-specific antibody
production guided and augmented by
certain types of immune cells, such as
T and B cells, which work together to
neutralize or destroy the disease-causing
agent. Immune responses to viruses like
SARS–CoV–2 can be measured in
several ways. For instance, blood serum
can be taken and exposed to specific
proteins found on the SARS–CoV–2
virus, in order to measure the presence
of antibodies in the blood. Another
antibody test, the neutralization test,
measures the ability of the antibodies
present in a serum to neutralize
infectivity and prevent cells from being
infected. T cell immunity can be
measured using techniques that target a
specific biomolecule that is specific to
SARS–CoV–2.
A considerable number of individuals
who were previously infected with
SARS–CoV–2 do not appear to have
acquired effective immunity to the virus
(Psichogiou et al., September 13, 2021;
Wei et al., July 5, 2021; Cavanaugh et
al., August 13, 2021). The level of
protection afforded by infection-
induced immunity appears to depend
on the severity of individuals’
infections. In a study from Greece,
immunogenicity was compared between
healthcare workers who were
vaccinated with Pfizer-BioNTech and
unvaccinated patients who acquired a
natural infection (Psichogiou et al.,
September 13, 2021). The researchers
found that the immune response in
unvaccinated individuals correlated to
the severity of their disease. Fully
vaccinated healthcare workers had
immune responses (measured as
antibody levels specific to SARS–CoV–
2) that were 1.3 times greater than
patients who had critical cases of
COVID–19 cases, 2.5 times greater than
patients who had moderate to severe
cases, and 10.5 times greater than
patients who had asymptomatic/mild
illnesses. Similarly, another study found
that 24.0% (1,742 of 7,256) of
individuals who had a previous SARS–
CoV–2 infection were seronegative (i.e.,
did not produce antibodies in response
to the virus), suggesting that the
previous infection provided insufficient
protection against future infection (Wei
et al., July 5, 2021). Individuals who
were seronegative were typically older,
had lower viral burdens when infected,
and were more likely to be
asymptomatic. The authors posited that
the immunity of those who were
seropositive (i.e., did produce
antibodies in response to the virus)
would provide some measure of
protection, but that these individuals
would benefit from a vaccination
booster. This position appears to be
validated by a study that compared the
reinfection rates of individuals in
Kentucky based on their post-recovery
vaccination status (Cavanaugh et al.,
August 13, 2021). Unvaccinated
individuals with previous infection
were found to be 2.3 times more likely
to be reinfected than those who were
vaccinated after their prior infection.
These studies demonstrate not only that
those with milder infections may not be
protected against future infection, but
that it is difficult to tell, on an
individual level, which individuals
might have had prior infections that
conveyed protection equivalent to that
provided by vaccination.
A number of other studies indicate
that fully vaccinated individuals may be
better protected against future infection
than those with previous infections. A
study in Massachusetts concluded that
the immunity conveyed from a previous
SARS–CoV–2 infection was effectively
equivalent to the immunity of an
uninfected individual who has had only
one dose of an mRNA vaccine
(Naranbhai et al., October 13, 2021). The
authors found that fully vaccinated
individuals have an immune response
(i.e., antibodies and neutralization) well
above the levels observed in
unvaccinated, previously-infected
individuals. German researchers found
that individuals who were fully
vaccinated with Pfizer-BioNTech had a
significantly greater immune response
(as measured by antibody levels) than
unvaccinated individuals who had
infections, concluding that vaccination
would be needed for those unvaccinated
individuals to have similar protection
against infection (Herzberg et al., June
13, 2021). Similarly, a Dutch study
observed that vaccination greatly
improved the immune response (as
measured by antibodies and virus-
specific T cells) of individuals who had
recovered from COVID–19 (Geers et al.,
May 25, 2021). Planas et al. (August 12,
2021) also noted that immune response
(as measured by neutralization) to the
Alpha, Beta, and Delta (B.1.617.2)
variants in unvaccinated, previously-
infected individuals was considerably
less than the immune response in
individuals five weeks after their second
Pfizer-BioNTech dose. When
unvaccinated, previously-infected
individuals were vaccinated, their
immune response (as measured by
neutralization) increased by more than
an order of magnitude. Likewise, Wang
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et al. (July 15, 2021) found that the
immune response (as measured by
neutralization) of those with previous
SARS–CoV–2 infection increased by
more than an order of magnitude against
Alpha (B.1.1.7), Beta (B.1.351), Iota
(B.1.526), and Gamma (P.1) variants
when they were vaccinated. These
studies show that infection-induced
immunity may not equal the protection
afforded by vaccination and that
vaccination greatly improves the
immune response of those who were
previously infected.
The aforementioned studies indicate
that immunity acquired through
infection appears to be less protective
than vaccination. There are also a
number of epidemiological studies that
provide some evidence that infection-
acquired immunity has the potential to
provide a significant level of protection
against reinfection. As OSHA discusses
in greater detail below, these studies
suffer from methodological limitations
that render them inconclusive about the
level of immunity conferred by
infection, and therefore OSHA is unable
to establish that such immunity
eliminates grave danger. This
determination is based in three parts.
First, the epidemiological literature
OSHA reviewed generally suffers from
selection bias to a degree that it serves
as an unreliable basis on which to reach
a robust conclusion on whether
previous infection removes workers
from grave danger. In general, the
studies described below do not account
for people who had mild COVID–19
infections, leading to study findings
regarding the level of protection
afforded by prior infection that are not
generally applicable. Second, the tests
employed in the studies are being used
in ways that they were not originally
designed to be employed. These tests
are powerful tools, but there are
limitations to their use in determining if
a specific individual is, in fact,
protected from the grave danger of
SARS–CoV–2. Particularly problematic
is the lack of established thresholds to
determine full protection from
reinfection or even a standardized
methodology to determine infection
severity or immune response. Thus,
while these studies broadly establish
some increase in protectiveness against
SARS–CoV–2 among the studied
populations, they as yet are unable to
provide a reasonable degree of certainty
on whether the degree of protection
afforded any particular individual from
their prior infection is sufficient to
eliminate the grave danger from
reinfection (see Milne, et al., October 21,
2021.) Third, while the research
methodology itself creates difficulties in
the context of OSHA’s grave danger
inquiry, the implications of trying to
apply investigative research
methodology to clinical practice are
even more challenging. The need for the
development of standardized methods
and criteria for establishing sufficient
immunity preclude the application of
the studies’ findings to robust and
reliable clinical practice. These three
rationales for OSHA’s finding are
described in more detail below.
Several epidemiological studies used
previous RT–PCR positive cases to
define previous infections (Hansen et
al., March 27, 2021; Pilz et al., February
11, 2021; Vitale et al., May 28, 2021;
Pouwels et al., October 14, 2021; Braeye
et al., September 15, 2021; Hall et al.,
April 17, 2021). RT–PCR tests,
particularly in the beginning of the
pandemic, were given high priority to
discern who seeking medical care was,
in fact, infected. For instance, the
progression of testing from medical
needs to more of a community
perspective is illustrated in Denmark
(Vrangbaek et al., April 29, 2021).
Denmark, considered one of the gold
standard countries for its
comprehensive testing program, missed
five infections for every one it identified
in the spring of 2020 (Espenhaim et al.,
August 22, 2021). Hansen et al. (March
27, 2021) depended greatly on these first
surge infection definitions to determine
that survivors had protection of 80.5%
effectiveness during the second surge in
Denmark from September through
December, 2020. By only noting RT–
PCR positives from the spring when
testing was limited and highly focused
on health care needs, it seems apparent
that the study excluded many less
severe cases (which are less likely to
result in an effective immune response
against reinfection), leading to results
that may suggest greater protection is
afforded by infection than in actuality.
Even by December of 2020, it appears
Denmark’s gold standard
comprehensive testing approach was
only able to capture roughly half of all
infections. Similar systemic
undercounts have also been determined
to be true in the United States where
approximately three out of four
infections have never been reported
(CDC, July 27, 2021b).
It is important to recognize that RT–
PCR testing was not implemented to
find every infection, but was used
instead to assist in determining when
medical and community interventions
were necessary. Infections without
symptoms or with mild symptoms likely
would not require medical intervention
and, therefore, would likely not be
identified via testing. The absence of
this population that is more vulnerable
to reinfection, in these studies,
undercuts their usefulness in OSHA’s
grave danger analysis, because they may
overestimate the protectiveness of
immunity acquired through infection.
Several other studies in regions less
known for their sampling approach than
Denmark also were heavily dependent
on early, limited pandemic RT–PCR
testing. An Austrian study found a
roughly ten-fold decrease in reinfection
in survivors of reported infections from
February to April 30, 2020 in
comparison with the general public
(Pilz et al., February 11, 2021). The
authors noted that ‘‘infections in the
first wave are likely to have been far
more common than the documented
ones’’ and referred to their results as a
‘‘rough estimate.’’ Researchers at the
Cleveland Clinic also found a reduced
rate of reinfection in those who had a
reported previous infection compared
with those with no prior infection
(13.8% infection rate for those
previously uninfected and 4.9%
infection rate for those previously
infected), but noted that testing was
limited in that the ‘‘Cleveland Clinic did
not test asymptomatic patients unless
they were admitted to hospital or
undergoing a procedure/surgery’’
(Sheehan et al., March 15, 2021). These
criteria for testing create uncertainty in
determining the level of effectiveness
previous infection provides against
SARS–CoV–2 because many individuals
with asymptomatic infections would not
have been tested. Similar issues are also
found in studies on populations in Italy,
Belgium, and the UK (Vitale et al., May
28, 2021; Braeye et al., September 15,
2021; Pouwels et al., October 14, 2021).
To avoid the well-known problems
with RT–PCRs defining previous
infection, other studies have defined
previous infection as testing positive for
antibodies specific for SARS–CoV–2
(Lumley et al., February 11, 2021; Abu-
Raddad et al., April 28, 2021; Hall et al.,
April 17, 2021). As noted above,
previous infection does not necessarily
result in a seropositive outcome; one
study indicated that nearly a quarter
(24%) of those infected with SARS–
CoV–2 subsequently showed no sign of
an immune response in SARS–CoV–2-
specific antibody testing (Wei et al., July
5, 2021). Therefore, studies only
considering seropositive individuals are
in essence studying only the individuals
most likely to have protection from
reinfection. Lumley et al. (February 11,
2021) found that those having a
seropositive response had almost an
order of magnitude fewer infections
(e.g., 0.11 adjusted incidence rate ratio).
Likewise, Abu-Raddad et al. (April 28,
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2021) found that seropositive
individuals were reinfected less (0.7%)
during their study period in comparison
to seronegative individuals (3.09%). In
addition to the bias associated with
using antibodies to determine previous
infection, the authors also noted that
there may have been issues with being
able to document cases with mild or no
symptoms.
Hall et al. (April 17, 2021) cast a
wider net by defining previous infection
to include both positive RT–PCR tests
and seropositivity. The researchers
found that those who were considered
previously infected had an 84% lower
risk of infection compared to those who
were unvaccinated with no record of
infection. While the study does attempt
to capture as many previously-infected
individuals as possible, this does not
actually address the weaknesses of each
method. Those with less severe
infections were less likely to have
sought out or been able to get an RT–
PCR test during the first surge, which is
when an overwhelming number of the
previous infections were recorded in
this study (March through May, 2020).
Additionally, the less severe infections
that are most likely underrepresented in
the study appear to be the ones that are
less likely to produce seropositivity.
Shenai et al. (September 21, 2021)
pooled several studies with the above
issues and concluded that immunity
acquired through a previous infection
from SARS–CoV–2 may be as protective
as, or more protective than, the
immunity afforded by vaccination to an
individual without previous infection.
However, authors of several of those
underlying studies used in the analysis
noted that their studies were limited by
not having the capability to fully
account for asymptomatic infections
(the aforementioned Lumley et al., July
3, 2021; Gazit et al., August 25, 2021;
Shrestha et al., June 19, 2021). As noted
earlier, infection severity appears to be
correlated with the robustness of
immunity acquired through that
infection, so the failure to account for
asymptomatic infections may mean that
this finding is related to the protection
afforded by more severe disease. While
pooled analyses can be utilized to make
powerful observations, those
observations are highly dependent upon
the underlying studies not sharing the
same methodological weakness which,
in this case, was the studies’ exclusion
of asymptomatic infections.
Moreover, while the evidence
suggests that severe infection may
provide significant protection against
reinfection in some cases (Milne et al.,
October 21, 2021), the level of
protection cannot be determined on an
individual basis. The studies discussed
above are based on tests that show only
whether a person was or was not
infected and provide no information
about the severity of the infection.
Because the studies are likely biased
towards those who had a relatively
serious infection, their findings cannot
be generalized to all individuals with
prior infections.
RT–PCR and antibody testing are
powerful tools with many clinical and
research applications. However, the
application of these tools cannot
determine what degree of protection a
particular individual has against SARS–
CoV–2 without a great deal of additional
study concerning thresholds
establishing individual immunity.
Therefore, these tools are not yet able to
assist OSHA in making more nuanced
findings about which workers who had
COVID–19 previously are at grave
danger. There is no established
threshold to determine full protection
from reinfection or a standardized
methodology to determine infection
severity or immune response. Studies
use Ct threshold to approximate viral
loads and infer disease severity, but that
metric depends on many variables (e.g.
time of collection during infection,
quality of collection, handling of
sample, specifics of the test protocol
and materials, precision in performing
the protocol) that are often of far less
importance when it is used as a crude
diagnostic to determine the presence of
an infection. In other words, it is
reasonable to say that the lower the Ct
count, the greater the likelihood that an
individual is at a lower reinfection risk;
however, the Ct count is greatly
dependent on the RT–PCR test used,
and how different laboratories may run
that test, which cannot be discerned.
Similarly, research needs to be done to
better identify the minimum protective
threshold of anti-SARS–CoV–2 serum
neutralizing antibodies (Milne et al.,
October 21, 2021). Thus, these studies
currently do not allow OSHA to
determine, with a reasonable degree of
certainty, how much protection
employees with prior infections have
against reinfection.
Furthermore, while the research
methodology itself raises challenges in
making the grave danger determination,
the implications of trying to apply
investigative research methodology to
clinical practice are even more difficult.
The lack of standardized methods and
standardized measures for immunity
preclude their application to robust and
reliable clinical practice. One major
drawback discussed above is that, in
contrast to vaccine studies where
researchers know who was vaccinated
with a standardized dosing regime,
scientific inquiries likely will not be
able to identify most individuals who
were infected, the degree of disease
experienced for those with a confirmed
infection, and the immunity against
reinfection. As of October 18, 2021,
several RT–PCR assays have been
authorized without standardization or
assessment with respect to measuring
disease severity (FDA, October 18,
2021). As noted above, the use of the Ct
threshold to approximate viral loads
and infer disease severity is unreliable.
As the FDA notes, the same is true about
antibody tests, which are considered to
be poor indicators for individuals to use
to determine whether they are protected
from reinfection (FDA, May 19, 2021).
There are many different SARS–CoV–2-
specific antibody tests that focus on
different specificity. Not only are the
outcomes of these tests not directly
comparable to each other, but the
specificity of these tests is not related to
any notion of protection against
reinfection. It can be reasonably said
that a greater antibody response means
a greater likelihood of protection against
infection, but, again, the science is not
clear what those thresholds are and
whether a threshold would be
comparable between laboratories. At
this point in time, even if OSHA
determined that some individuals with
prior infections are not at grave danger
from exposure to SARS–CoV–2, there is
no agreement on what indicators of
infection might be sufficient to confer
this level of immunity or how a
healthcare provider or employer could
document that a certain level of
immunity had been achieved.
Based on the best available evidence
described above, OSHA concludes that
while some individuals who were
infected with SARS–CoV–2 may have
significant protection from subsequent
infections, the level of protection
afforded by infection may be
significantly impacted by the severity of
the infection and some previously
infected individuals may have no future
protection at all. In addition, given the
limitations of the studies described
above, there is considerable uncertainty
as to whether any given individual is
adequately protected against reinfection.
Furthermore, the level of protection, if
any, provided by a given person’s
SARS–CoV–2 infection cannot be
ascertained based on currently-available
testing methods. Therefore, OSHA finds
that the requirements of this ETS are
necessary to protect unvaccinated
individuals who had prior SARS–CoV–
2 infections from the grave danger from
exposure to SARS–CoV–2.
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OSHA recognizes that its finding
regarding infection-induced immunity
is being made in an area of inquiry that
is currently on the ‘‘frontiers of
scientific knowledge’’ (Indus. Union
Dep’t, AFL–CIO v. Am. Petroleum Inst.,
448 U.S. 607, 656 (1980)). For these
reasons, OSHA finds that those who
have previously been infected with
SARS–CoV–2 and are not yet fully
vaccinated are at grave danger from
SARS–CoV–2 exposure and that it is
necessary to protect these workers via
vaccination, or testing and the use of
face coverings, under this standard.
OSHA will continue to follow
developments on this issue, however,
and make appropriate adjustments to
this ETS if the evidence warrants.
VI. Conclusion.
OSHA finds that many employees in
the U.S. who are not fully vaccinated
against COVID–19 face a grave danger
from exposure to SARS–CoV–2 in the
workplace. OSHA’s determination is
based on the severe health
consequences of exposure to the virus,
including death; powerful lines of
evidence demonstrating the
transmissibility of the virus in the
workplace; and the prevalence of
infections in employee populations.
With respect to the grave health
consequences of exposure to SARS–
CoV–2, OSHA has found that regardless
of where and how exposure occurs,
COVID–19 can result in death. Even for
those who survive a SARS–CoV–2
infection, the virus can cause serious,
long-lasting, and potentially permanent
health effects. Serious cases of COVID–
19 require hospitalization and dramatic
medical interventions, and might leave
employees with permanent and
disabling health effects. Both death and
serious cases of COVID–19 requiring
hospitalization provide independent
bases for OSHA’s finding of grave
danger. The evidence is clear that the
safe and effective vaccines authorized
and/or approved for use in the United
States greatly reduce the likelihood of
these severe outcomes.
The best available evidence on the
science of transmission of the virus
makes clear that SARS–CoV–2 is
transmissible from person to person in
shared workplace settings. The
likelihood of transmission can be
exacerbated by common characteristics
of many workplaces, including working
indoors, working with others for
extended periods of time, poor
ventilation, and close contact with
potentially infectious individuals. The
likelihood of transmission in the
workplace is also exacerbated by the
presence of unvaccinated workers, who
are more likely than those who are
vaccinated to be infected and transmit
the virus to others. Every workplace
SARS–CoV–2 exposure or transmission
has the potential to cause severe illness
or even death, particularly in
unvaccinated workers. Taken together,
the severe health consequences of
COVID–19 and the evidence of its
transmission in environments
characteristic of the workplaces covered
by this ETS demonstrate that exposure
to SARS–CoV–2 represents a grave
danger to unvaccinated employees in
many workplaces throughout the
country.
The existence of a grave danger to
employees from SARS–CoV–2 is further
supported by the toll the pandemic has
already taken on the nation as a whole
and the number of workers who remain
unvaccinated. Although OSHA cannot
state with precision the total number of
workers in our nation who have
contracted COVID–19 at work and
became sick or died, COVID–19 has
killed 723,205 people in the United
States as of October 18, 2021 (CDC,
October 18, 2021—Cumulative US
Deaths). That death toll includes
131,478 people who were 18 to 64 years
old, prime working age (CDC, October
18, 2021—Demographic Trends, Deaths
by Age Group). OSHA estimates that
there are over 26 million workers
subject to the rule who remain
unvaccinated at present and therefore
are in grave danger. As a result of this
ETS, the agency estimates that 72% of
them will be vaccinated (see OSHA,
October 2021c).
Current mortality data shows that
unvaccinated people of working age
have a 1 in 202 chance of dying when
they contract COVID–19 (CDC, October
18, 2021—Demographic Trends, Cases
by Age Group; Demographic Trends,
Deaths by Age Group). As of October 18,
2021, close to 45 million people in the
United States have been reported to
have infections, and thousands of new
cases were being identified daily (CDC,
October 18, 2021—Daily Cases).One in
14 reported cases of COVID–19 in
people ages 18 to 64 becomes severe and
requires hospitalization (CDC, October
18, 2021—Demographic Trends, Cases
by Age; Total Hospitalizations, by Age).
Moreover, public health officials agree
that these numbers fail to show the full
extent of the deaths and illnesses from
this disease, and racial and ethnic
minority groups are disproportionately
represented among COVID–19 cases,
hospitalizations, and deaths (CDC,
December 10, 2020; CDC, May 26, 2021;
Escobar et al., February 9, 2021; Gross
et al., October 2020; McLaren, June
2020; CDC, October 6, 2021). Given this
context, OSHA is confident in its
finding that exposure to SARS–CoV–2
poses a grave danger to the employees
covered by this ETS.
The above analysis fully satisfies the
OSH Act’s requirements for finding a
grave danger. Although OSHA usually
performs a quantitative risk assessment
based on extrapolations among exposure
levels before promulgating a health
standard under section 6(b)(5) of the
OSH Act (29 U.S.C. 655(b)(5)), that type
of analysis is not necessary in this
situation. OSHA has most often invoked
section 6(b)(5) authority to regulate
exposures to chemical hazards
involving much smaller populations,
many fewer cases, extrapolations from
animal evidence, long-term exposure,
and delayed effects. In those situations,
mathematical modelling is necessary to
evaluate the extent of the risk at
different exposure levels. The gravity of
the danger presented by a disease with
acute effects like COVID–19, on the
other hand, is made obvious by a
straightforward count of deaths and
illnesses caused by the disease, which
reach sums not seen in at least a
century. The evidence compiled above
amply supports OSHA’s finding that
SARS–CoV–2 presents a grave danger in
American workplaces. In the context of
ordinary 6(b) rulemaking, the Supreme
Court has said that the OSH Act is not
a ‘‘mathematical straitjacket,’’ nor does
it require the agency to support its
findings ‘‘with anything approaching
scientific certainty,’’ particularly when
operating on the ‘‘frontiers of scientific
knowledge’’ (Indus. Union Dep’t, AFL–
CIO v. Am. Petroleum Inst., 448 U.S.
607, 655–56 (1980)). This is true a
fortiori in the current national crisis,
where OSHA must act to ensure
employees are adequately protected
from the hazard presented by the
COVID–19 pandemic (see 29 U.S.C
655(c)(1)).The grave danger from SARS–
CoV–2 represents the biggest threat to
employees in OSHA’s more than 50-year
history. The threat applies to employees
in all sectors covered by OSHA,
including general industry,
construction, maritime, agriculture, and
healthcare. Having made the
determination of grave danger, as well
as the determination that an ETS is
necessary to protect employees from
exposure to SARS–CoV–2 (see Need for
the ETS, Section III.B. of this preamble),
OSHA is required to issue this standard
to protect employees from getting sick
or dying from COVID–19 acquired at
work (see 29 U.S.C. 655(c)(1)).
References
Allen JG and Ibrahim AM. (2021, May 25).
Indoor air changes and potential
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61425
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
implications for SARS–CoV–2
transmission. JAMA 325(20): 2112–2113.
doi:10.1001/jama.2021.5053. (Allen and
Ibrahim, May 25, 2021)
Abu-Raddad LJ et al. (2021, May 1). SARS–
Cov–2 antibody-positivity protects
against reinfection for at least seven
months with 95% efficacy.
EClinicalMedicine, 2021. 35: p. 100861.
https://doi.org/10.1016/
j.eclinm.2021.100861. (Abu-Raddad et
al., May 1, 2021)
Andrews et al. (2021, September 21). Vaccine
effectiveness and duration of protection
of Comirnaty, Vaxzevria and Spikevax
against mild and severe COVID–19 in the
UK. medRxiv preprint. doi:10.1101/
2021.09.15.21263583. (Andrews et al.,
September 21, 2021)
Bajema KL et al. (2021, September 10).
Effectiveness of COVIF–19 mRNA
Vaccines Against COVID–19—
Associated Hospitzalization—Five
Veteran Affairs Medical Centers, United
States February 1–August 6, 2021.
MMWR Morb Mortal Wkly Rep 2021; 70:
early release. https://www.cdc.gov/
mmwr/volumes/70/wr/pdfs/mm7037e3-
H.pdf. (Bajema et al., September 10,
2021)
Bernal JL et al. (2021, August 12).
Effectiveness of Covid–19 Vaccines
against the B.1.617.2 (Delta) Variant. N
Eng J Med. 2021 Aug 12; 385(7): 585–
594. doi:10.1056/NEJMoa2108891.
(Bernal et al., August 12, 2021)
Braeye T et al. (2021, September 15). Vaccine
effectiveness against infection and
onwards transmission of COVID–19:
Analysis of Belgian contact tracing data,
January–June 2021. Vaccine, 2021.
39(39): p. 5456–5460. doi:10.1016/
j.vaccine.2021.08.060. (Braeye et al.,
September 15, 2021)
Bruxvoort et al. (September 2, 2021). Real-
World Effectiveness of the mRNA–1273
Vaccine Against COVID–19: Interim
Results from a Prospective Observational
Cohort Study. Lancet preprint. https://
papers.ssrn.com/sol3/
papers.cfm?abstract_id=3916094.
(Bruxvoort et al., September 2, 2021)
Bui D et al. (2020, August 17). Racial and
ethnic disparities among COVID–19
cases in workplace outbreaks by industry
sector—Utah, March 6–June 5, 2020.
MMWR: 69: 1133–1138. https://
www.cdc.gov/mmwr/volumes/69/wr/
mm6933e3.htm.(Bui et al., August 17,
2020)
Bulfone TC et al. (2020, November 29).
Outdoor Transmission of SARS–CoV–2
and Other Respiratory Viruses: A
Systematic Review. (2020). The Journal
of Infectious Diseases 223: 550–561.
https://doi.org/10.1093/infdis/jiaa742.
(Bulfone et al., November 29, 2020)
Cavanaugh A et al. (2021, August 13).
Reduced Risk of Reinfection with SARS–
CoV–2 After COVID–19 Vaccination—
Kentucky, May–June 2021. MMWR Morb
Mortal Wkly Rep 2021; 70: 32. 1081–
1082. https://www.cdc.gov/mmwr/
volumes/70/wr/mm7032e1.htm.
(Cavanaugh et al., August 13, 2021)
Centers for Disease Control and Prevention
(CDC). (2020, December 10). COVID–19
Racial and Ethnic Health Disparities.
https://www.cdc.gov/coronavirus/2019-
ncov/community/health-equity/racial-
ethnic-disparities/index.html. (CDC,
December 10, 2020)
Centers for Disease Control and Prevention
(CDC). (2021, April 19). Health equity
considerations and racial and ethnic
minority groups. https://www.cdc.gov/
coronavirus/2019-ncov/community/
health-equity/race-ethnicity.html. (CDC,
April 19, 2021)
Center for Disease Control and Prevention
(CDC). (2021, May 7). Scientific Brief:
SARS–CoV–2 Transmission. https://
www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/SARS-cov-2-
transmission.html#print. (CDC, May 7,
2021)
Centers for Disease Control and Prevention
(CDC). (2021a, May 24). COVID data
tracker. Trends in number of COVID–19
cases and deaths in the US reported to
CDC, by state/territory: Trends in Total
COVID–19 Deaths in the United States
Reported to CDC. https://covid.cdc.gov/
covid-data-tracker/#trends_
dailytrendscases. (CDC, May 24, 2021a)
Centers for Disease Control and Prevention
(CDC). (2021b, May 24). COVID data
tracker. Trends in number of COVID–19
cases and deaths in the US reported to
CDC, by state/territory: Trends in Total
COVID–19 Cases in the United States
Reported to CDC. https://covid.cdc.gov/
covid-data-tracker/#trends_
dailytrendscases. (CDC, May 24, 2021b)
Centers for Disease Control and Prevention
(CDC). (2021c, May 24). COVID data
tracker. Variant proportions. https://
covid.cdc.gov/covid-data-tracker/
#variant-proportions. (CDC, May 24,
2021c)
Centers for Disease Control and Prevention
(CDC). (2021, May 26). Health
disparities: Race and Hispanic origin.
https://www.cdc.gov/nchs/nvss/vsrr/
covid19/health_disparities.htm. (CDC,
May 26, 2021)
Center for Disease Control and Prevention
(CDC). (2021, May 28). COVID Data
Tracker Weekly Review: What’s Up,
Doc? https://www.cdc.gov/coronavirus/
2019-ncov/covid-data/covidview/past-
reports/05282021.html#print. (CDC, May
28, 2021)
Center for Disease Control and Prevention
(CDC). (2021, June 25). COVID Data
Tracker Weekly Review: Keep Variants at
Bay. Get Vaccinated Today. https://
www.cdc.gov/coronavirus/2019-ncov/
covid-data/covidview/past-reports/
06252021.html. (CDC, June 25, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, July 27). Estimated
COVID–19 Burden. https://www.cdc.gov/
coronavirus/2019-ncov/cases-updates/
burden.html. (CDC, July 27, 2021)
Center for Disease Control and Prevention
(CDC). (2021, August 13). How to Protect
Yourself & Others. https://www.cdc.gov/
coronavirus/2019-ncov/prevent-getting-
sick/prevention.html. (CDC, August 13,
2021)
Centers for Disease Control and Prevention
(CDC). (2021, August 26). Delta Variant:
What we know about the science.
https://www.cdc.gov/coronavirus/2019-
ncov/variants/delta-variant.html?s_
cid=11512:cdc%20delta%20variant:sem.
ga:p:RG:GM:gen:PTN:FY21. (CDC.
August 26, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, September 1). Interim
Public Health Recommendations for
Fully Vaccinated People. https://
www.cdc.gov/coronavirus/2019-ncov/
vaccines/fully-vaccinated-guidance.html.
(CDC, September 1, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, September 15). Science
brief: background rationale and evidence
for public health recommendations for
fully vaccinated people. https://
www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/fully-vaccinated-
people.html. (CDC, September 15, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, September 21). Appendix
A—Glossary of key terms. https://
www.cdc.gov/coronavirus/2019-ncov/
php/contact-tracing/contact-tracing-
plan/appendix.html#print. (CDC,
September 21, 2021)
Center for Disease Control and Prevention
(CDC). (2021, October 1). COVID Data
Tracker Weekly Review: Three Point
Shot. https://www.cdc.gov/coronavirus/
2019-ncov/covid-data/covidview/
index.html. (CDC, October 1, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, October 4). SARS–CoV–2
Variant Classifications and Definitions.
https://www.cdc.gov/coronavirus/2019-
ncov/variants/variant-info.html. (CDC,
October 4, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, October 6). Health
Disparities: Provisional Death Counts for
Coronavirus Disease 2019 (COVID–19).
https://www.cdc.gov/nchs/nvss/vsrr/
covid19/health_disparities.htm. (CDC,
October 6, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, October 18). COVID Data
Tracker. https://covid.cdc.gov/covid-
data-tracker/. (CDC, October 18, 2021)
Cevik M et al. (2021, August 1). Severe Acute
Respiratory Syndrome Coronavirus 2
(SARS–CoV–2) Transmission Dynamics
Should Inform Policy. Clinical Infectious
Disease 73(S2): S170–S176. doi:10.1093/
cid/ciaa1442. (Cevik et al., August 1,
2021)
Chan E et al. (2010, December 14). Global
capacity for emerging infectious disease
detection. Proceedings of the National
Academy of Sciences of the United
States of America, 107(50), 21701–21706.
https://doi.org/10.1073/
pnas.1006219107. (Chan et al., December
14, 2010)
Chen YH et al. (2021, June 4). Excess
mortality associated with the COVID–19
pandemic among Californians 18–65
years of age, by occupational sector and
occupation: March through November
2020. PLoS One 16(6): e0252454.
doi:10.1371/journal.pone.0252454.
(Chen et al., June 4, 2021)
Chia PY et al. (2021, July 31). Virological and
serological kinetics of SARS–CoV–2
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Delta variant vaccine-breakthrough
infections: A multi-center cohort study.
medRxiv preprint. doi: https://doi.org/
10.1101/2021.07.28.21261295. (Chia et
al., July 31, 2021)
Colorado Department of Public Health &
Environment (CDPHE)/Colorado State
Emergency Operations Center (CSEOC)
(2021, September 8). COVID–19
Outbreak data. https://
covid19.colorado.gov/covid19-outbreak-
data. (CDPHE/CSEOC, September 8,
2021)
Contreras Z et al. (2021, July). Industry
Sectors Highly Affected by Worksite
Outbreaks of Coronavirus Disease, Los
Angeles County, California, USA, March
19–September 30, 2020. Emerg Infect
Dis. 2021; 27(7): 1769–1775.
doi:10.3201/eid2707.210425. (Contreras
et al., July, 2021)
Dave D et al. (2020, December 2). The
Contagion Externality of a
Superspreading Event: The Sturgis
Motorcycle Rally and COVID–19. South
Econ J 2020 Dec 2; 10. doi:10.1002/
soej.12475. (Dave et al., December 2,
2020)
de Gier B et al. (2021, August 5). Vaccine
effectiveness against SARS–CoV–2
transmission and infections among
household and other close contacts of
confirmed cases, the Netherlands,
February to May 2021. Eurosurveillance
26(31): 7–13. doi:10.2807/1560–
7917.ES.2021.26.31.2100640. (de Gier et
al., August 5, 2021)
Dougherty K et al. (2021, July 16). SARS–
CoV–2 B.1.617.2 (Delta) variant COVID–
19 outbreak associated with a gymnastics
facility—Oklahoma, April–May 2021.
MMWR Morb Mortal Wkly Rep 70:
1004–1007. http://dx.doi.org/10.15585/
mmwr.mm7028e2external icon.
(Dougherty et al., July 16, 2021)
Egger F et al. (2021, March 18). Does playing
football (soccer) lead to SARS–CoV–2
transmission? A case study of 3 matches
with 18 infected football players. Science
and Medicine in Football. doi:https://
doi.org/10.1080/24733938.2021.1895442.
(Egger et al., March 18, 2021)
Elliott P et al. (2021, September 10). REACT–
1 round 13 final report: Exponential
growth, high prevalence of SARS–CoV–
2 and vaccine effectiveness associated
with Delta variant in England during
May to July 2021. medRxiv preprint.
doi:10.1101/2021.09.02.21262979.
(Elliott et al., September 10, 2021)
Escobar GJ et al. (2021, February 9). Racial
disparities in COVID–19 testing and
outcomes. Annals of Internal Medicine.
doi:10.7326/M20–6979. (Escobar et al.,
February 9, 2021).
Espenhain L et al. (2021, August 22).
Prevalence of SARS–CoV–2 antibodies in
Denmark: Nationwide, population-based
seroepidemiological study. European
Journal of Epidemiology (2021) 36: 715–
725. https://doi.org/10.1007/s10654–021-
00796-8. (Espenhain et al., August 22,
2021)
Eyre DW et al. (2021, September 29). The
impact of SARS–CoV–2 vaccination on
Alpha and Delta variant transmission.
medRxiv preprint. doi:10.1101/
2021.09.28.21264260. (Eyre et al.,
September 29, 2021)
Fennelly K. (2020, July 24). Particle sizes of
infectious aerosols: Implications for
infection control. Lancet Respir Med
2020; 8: 914–24. https://doi.org/10.1016/
S2213-2600(20)30323-4. (Fennelly, July
24, 2020)
Fisman DN and Tuite AR. (2021, July 12).
Progressive Increase in Virulence of
Novel SARS–CoV–2 Variants in Ontario,
Canada. medRxiv 2021.07.05.21260050.
https://doi.org/10.1101/
2021.07.05.21260050. (Fisman and Tuite,
July 12, 2021)
Food and Drug Administration (FDA). (2020,
December 11). Emergency use
authorization for an unapproved product
review memorandum (Pfizer-BioNTech
COVID–19 vaccine/BNT 162b2 mRNA–
1273). https://www.fda.gov/emergency-
preparedness-and-response/coronavirus-
disease-2019-covid-19/pfizer-biontech-
covid-19-vaccine. (FDA, December 11,
2020)
Food and Drug Administration (FDA). (2020,
December 18). Emergency use
authorization for an unapproved product
review memorandum (Moderna COVID–
19 vaccine/mRNA–1273). https://
www.fda.gov/emergency-preparedness-
and-response/coronavirus-disease-2019-
covid-19/moderna-covid-19-vaccine.
(FDA, December 18, 2020)
Food and Drug Administration (FDA). (2021,
February 26). Janssen COVID–19
vaccine. Vaccines and Related Biological
Products Advisory Committee February
26, 2021 Meeting Briefing Document.
https://www.fda.gov/media/146219/
download. (FDA, February 26, 2021)
Food and Drug Administration (FDA). (2021,
May 19). Antibody testing is not
currently recommended to assess
immunity after COVID–19 vaccination:
FDA safety communication. https://
www.fda.gov/medical-devices/safety-
communications/antibody-testing-not-
currently-recommended-assess-
immunity-after-covid-19-vaccination-
fda-safety. (FDA, May 19, 2021)
Food and Drug Administration (FDA). (2021,
October 18). In vitro diagnostics EUAs—
Molecular diagnostic tests for SARS–
CoV–2. https://www.fda.gov/medical-
devices/coronavirus-disease-2019-covid-
19-emergency-use-authorizations-
medical-devices/in-vitro-diagnostics-
euas-molecular-diagnostic-tests-SARS-
cov-2. (FDA, October 18, 2021)
Fowlkes A et al. (2021, August 27).
Effectiveness of COVID–19 Vaccines in
Preventing SARS–CoV–2 Infection
Among Frontline Workers Before and
During B.1.617.2 (Delta) Variant
Predominance—Eight U.S. Locations,
December 2020–August 2021. MMWR
Morb Mortal Wkly Rep 70: 1167–1169.
doi: http://dx.doi.org/10.15585/
mmwr.mm7034e4external icon. (Fowlkes
et al., August 27, 2021)
Gazit S et al. (2021, August 25, 2021).
Comparing SARS–CoV–2 natural
immunity to vaccine-induced immunity:
Reinfection versus breakthrough
infections. medRxiv preprint.
doi:10.1101/2021.08.24.21262415. (Gazit
et al., August 25, 2021)
Geers D et al. (2021, May 25). SARS–CoV–2
variants of concern partially escape
humoral but not T cell responses in
COVID–19 convalescent donors and
vaccine recipients. Science Immunology
2021 May 25; 6(59). doi:10.1126/
sciimmunol.abj1750. (Geers et al., May
25, 2021)
Gold JAW et al. (2021, February 26). Georgia
K–12 School COVID–19 Investigation
Team. Clusters of SARS–CoV–2 Infection
Among Elementary School Educators
and Students in One School District—
Georgia, December 2020–January 2021.
MMWR Morb Mortal Wkly Rep.
70(8):289–292. doi:10.15585/
mmwr.mm7008e4. Erratum in: MMWR
Morb Mortal Wkly Rep. 2021 Mar 12;
70(10): 364. PMID: 33630823; PMCID:
PMC8344983. (Gold et al., February 26,
2021)
Goldberg Y et al. (2021, August 30). Waning
immunity of the BNT162b2 vaccine: A
nationwide study from Israel. medRxiv
preprint. https://doi.org/10.1101/
2021.08.24.21262423. (Goldberg et al.,
August 30, 2021)
Grannis SJ et al. (2021, September 10).
Interim Estimates of COVID–19 Vaccine
Effectiveness Against COVID–19-
Associated Emergency Department or
Urgent Care Clinic Encounters and
Hospitalizations Among Adults During
SARS–CoV–2 B.1.617.2 (Delta) Variant
Predominance—Nine States, June–
August 2021. MMWR Morb Mortal Wkly
Rep 2021; 70: early release. https://
www.cdc.gov/mmwr/volumes/70/wr/
mm7037e2.htm. (Grannis et al.,
September 10, 2021)
Griffin JB et al. (2021, August 27). SARS–
CoV–2 Infections and Hospitalizations
Among Persons Aged >16 Years by
Vaccination Stats—Los Angeles County,
California, May 1–July 25, 2021. MMWR
Morb Mortal Wkly Rep 2021; 70(34):
1170–1176. https://www.cdc.gov/mmwr/
volumes/70/wr/pdfs/mm7034e5–H.pdf.
(Griffin et al., August 27, 2021)
Gross CP et al. (2020, October). Racial and
ethnic disparities in population-level
COVID–19 mortality. Journal of General
Internal Medicine 35(10): 3097–3099.
doi:10.1007/s11606–020–06081-w.
(Gross et al., October 2020)
Haas EJ et al. (2021, May 15). Impact and
effectiveness of mRNA BNT162b2
vaccine against SARS–CoV–2 infections
and COVID–19 cases hospitalizations,
and deaths following a nationwide
vaccination campaign in Israel: An
observational study using national
surveillance data. Lancet; 397: 1819–
1829. doi:10.1016/S0140–
6736(21)00947–8. (Haas et al., May 15,
2021)
Hales CM et al. (2020, February). Prevalence
of Obesity and Severe Obesity Among
Adults: United States, 2017–2018.
National Center for Health Statistics No.
30. https://www.cdc.gov/nchs/products/
databriefs/db360.htm. (Hales et al.,
February, 2020)
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22:27 Nov 04, 2021
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jspears on DSK121TN23PROD with RULES2

61427
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
Hall VJ et al. (2021, April 17). SARS–CoV–
2 infection reates of antibody-positive
compared with antibody-negative health-
care workers in England: A large,
multicenter, prospective cohort study
(SIREN). Lancet, 2021. 397(10283): p.
1459–1469. https://doi.org/10.1016/
S0140–6736(21)00675–9. (Hall et al.,
April 17, 2021)
Hansen CH et al. (2021, March 27).
Assessment of protection against
reinfection with SARS–CoV–2 among 4
million PCR-tested individuals in
Denmark in 2020: A population-level
observsational study. Lancet, 2021.
397(10280): p. 1204–1212. https://
doi.org/10.1016/S0140-6736(21)00575-4.
(Hansen et al., March 27, 2021)
Harris RJ et al. (2021, June 23). Effect of
Vaccination on Household Transmission
of SARS–CoV–2 in England. N Eng J
Med. 2021 Jun 23. doi:10.1056/
NEJMc2107717. (Harris et al., June 23,
2021)
Hawaii State. (2021, August 19). State of
Hawaii Weekly COVID–19 Cluster
Report. https://health.hawaii.gov/
coronavirusdisease2019/files/2021/08/
Hawaii_COVID-19_BiWeekly_Cluster_
Report_19-August-2021_FINAL.pdf.
(Hawaii State, August 19, 2021)
Hawkins D et al. (2021, January 10). COVID–
19 deaths by occupation, Massachusetts,
March 1–July 31, 2020. American Journal
of Industrial Medicine 2021: 1–7.
doi:10.1002/ajim.23227. (Hawkins et al.,
January 10, 2021)
Herzberg J et al. (2021, June 13). SARS–CoV–
2-antibody response in health care
workers after vaccination or natural
infection in a longitudinal observational
study. medRxiv preprint. doi:10.1101/
2021.06.09.21258648. (Herzberg et al.,
June 13, 2021)
Hetema¨ki I et al. (2021, July 29). An outbreak
caused by the SARS–CoV–2 Delta variant
(B.1.617.2) in a secondary care hospital
in Finland, May 2021. Euro Surveill
26(30): 2100636. doi:10.2807/1560–
7917.ES.2021.26.30.2100636. (Hetema¨ki
et al., July 29, 2021)
Johnson C. (2021, September 20). COVID has
killed about as many Americans as the
1918–19 flu. AP News. https://
apnews.com/article/science-health-
pandemics-united-states-coronavirus-
pandemic-c15d5c6dd7ece88d0832993f
11279fbb. (Johnson, September 20, 2021)
Jones B et al. (2021, February 11). SARS–
CoV–2 transmission during rugby league
matches: Do players become infected
after participating with SARS–CoV–2
positive players? Br J Sports Med.
doi:10.1136/bjsports-2020–103714.
(Jones et al., February 11, 2021)
Julin CH et al. (2021, September 22).
Household transmission of SARS–CoV–
2; a prospective longitudinal study
showing higher viral load and
transmissibility of the Alpha variant
compared to previous strains. medRxiv
preprint. https://doi.org/10.1101/
2021.08.15.21261478. (Julin et al.,
September 22, 2021)
Kapoor DA et al. (2020). The Impact of
Systematic Safety Precautions on
COVID–19 Risk Exposure and
Transmission Rates in Outpatient
Healthcare Workers. Rev Urol 22: 3.
https://pubmed.ncbi.nlm.nih.gov/
33239968. (Kapoor et al., 2020)
Keating D et al. (2021, September 15). The
pandemic marks another grim milestone:
1 in 500 Americans have died of covid-
19. Washington Post. https://
www.washingtonpost.com/health/
interactive/2021/1-in-500-covid-deaths/.
(Keating et al., September 15, 2021)
Keehner J et al. (2021, September 1).
Resurgence of SARS–CoV–2i Infection in
a highly vaccinated health system
workforce. N Engl J Med. 2021 Sep 1.
doi:10.1056/NEJMc2112981. Epub ahead
of print. PMID: 34469645. (Keehner et
al., September 1, 2021)
Kirbiyik U et al. (2020, November 6).
Network Characteristics and
Visualization of COVID–19 Outbreak in
a Large Detention Facility in the United
States—Cook County, Illinois. MMWR
69: 44. https://www.cdc.gov/mmwr/
volumes/69/wr/pdfs/mm6944a3-H.pdf.
(Kirbiyik et al., November 6, 2020)
Lan FY et al. (2020, September 26).
Association between SARS–CoV–2
infection, exposure risk and mental
health among a cohort of essential retail
workers in the USA. Occup Environ
Med. doi:10.1136/oemed-2020–106774.
(Lan et al., September 26, 2020)
Leclerc et al. (2021, April 28). What settings
have been linked to SARS–CoV–2
transmission clusters? Wellcome Open
Research 5: 83. doi:10.12688/
wellcomeopenres.15889.2. (Leclerc et al.,
April 28, 2021)
Levine-Tiefenburn M et al. (2021, March 29).
Initial report of decreased SARS–CoV–2
viral load after inoculation with the
BNT162b2 vaccine. Nature Medicine. 27:
790–792. https://doi.org/10.1038/s41591-
021-01316-7. (Levine-Tiefenbrun et al.,
March 29, 2021)
Levine-Tiefenburn M et al. (2021, September
1). Viral loads of Delta-variant SARS–
CoV–2 breakthrough infections following
vaccination and booster with the
BNT162b2 vaccine. medRxiv preprint.
https://doi.org/10.1101/
2021.08.29.21262798. (Levine-
Tiefenbrun et al., September 1, 2021)
Lewis D. (2021 March 30). Why indoor
spaces are still prime COVID hotspots.
Nature 592(7852): 22–25. doi:10.1038/
d41586–021–00810–9. PMID: 33785914.
(Lewis, March 30, 2021)
Li B et al. (2021, July, 12). Viral Infection and
Transmission in a Large Well-Traced
Outbreak Caused by the Delta SARS–
CoV–2 Variant. medRxiv
2021.07.07.21260122. https://doi.org/
10.1101/2021.07.07.21260122. (Li et al.,
July 12, 2021)
Liu Y and Rocklov J. (2021, August 4). The
reproductive number of the Delta variant
of SARS–CoV–2 is far higher compared
to the ancestral SARS–CoV–2 virus. J
Travel Med 2021 Aug 9; taab124. https://
doi.org/10.1093/jtm/taab124. (Liu and
Rocklov, August, 4, 2021)
Louisiana Department of Health (LDH).
(2021, August 24). COVID–19 outbreaks.
https://ldh.la.gov/index.cfm/page/3997.
(LDH, August 24, 2021)
Lumley SF et al. (2021, July 3). An
observational cohort study on the
incidence of severe acute respiratory
syndrome coronavirus 2 (SARS–CoV–2)
infection and B.1.1.7 variant infection in
healthcare workers by antibody and
vaccination status. Clinical Infectious
Diseases. 2021; ciab608. https://doi.org/
10.1093/cid/ciab608. (Lumley et al., July
3, 2021)
Lumley SF et al. (2021, February 11).
Antibody Status and Incidence of SARS–
CoV–2 Infection in Health Care Workers.
New England Journal of Medicine, 2020.
384(6): p. 533–540. doi:10.1056/
NEJMoa2034545. (Lumley et al.,
February 11, 2021)
Mack CD et al. (2021, January 29).
Implementation and evolution of
mitigation measures, testing, contact
tracing in the National Football League,
August 9–November 21, 2020. MMWR
Morb Mortal Wkly Rep 2021; 70(4): 130–
135. https://www.cdc.gov/mmwr/
volumes/70/wr/mm7004e2.htm. (Mack et
al., January 29, 2021)
McLaren J. (2020, June). Racial disparity in
COVID–19 deaths: Seeking economic
roots with Census data. NBER Working
Paper Series. Working Paper 27407.
doi:10.3386/w27407. (McLaren, June
2020).
Miller JS et al. (2021, April 30). COVID–19
Outbreak Among Farmworkers—
Okanogan County, Washington, May–
August 2020. MMWR Morb Mortal Wkly
Rep 2021; 70(17): 617–621. https://
www.cdc.gov/mmwr/volumes/70/wr/
mm7017a3.htm. (Miller et al., April 30,
2021)
Milne et al. (2021, October 21). Does
infection with or vaccine against SARS–
CoV–2 lead to lasting immunity? Lancet
Respir Med 2021. https://doi.org/
10.1016/S2213-2600(21)00407-0. (Milne
et al., October 21, 2021)
Mlcochova P et al. (2021, June 22). SARS–
CoV–2 B.1.617.2 Delta Variant
Emergence and Vaccine Breakthrough.
Research Square Platform LLC. 2021 Jun
22; doi:10.21203/rs.3.rs-637724/v1.
(Mlcochova et al., June 22, 2021)
Mora AM et al. (2021, September 15). Risk
Factors Assoicated with SARS–CoV–2
Infection Among Farmworkers in
Monterey County, California. JAMA
Network Open: 4(9): e2124116.
doi:10.1001/
jamanetworkopen.2021.24116. (Mora et
al., September 15, 2021)
Musser JM et al. (2021, July 22). Delta
Variants of SARS–CoV–2 Cause
Significantly Increased Vaccine
Breakthrough COVID–19 Cases in
Houston, Texas. medRxiv
2021.07.19.21260808; doi:10.1101/
2021.07.19.21260808. (Musser et al., July
22, 2021)
Nanduri S et al. (2021, August 27).
Effectiveness of Pfizer-BioNTech and
Moderna Vaccines in Preventing SARS–
CoV–2 Infection Among Nursing Home
Residents Before and During Widespread
Circulation of the SARS–CoV–2
VerDate Sep<11>2014
22:27 Nov 04, 2021
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61428
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
B.1.617.2 (Delta) Variant—National
Healthcare Safety Network, March 1–
August 1, 2021. MMWR Morb Mortal
Wkly Rep 2021; 70(34): 1163–1166.
https://www.cdc.gov/mmwr/volumes/70/
wr/mm7034e3.htm. (Nanduri et al.,
August 27, 2021)
Naranbhai V et al. (2021, October 13).
Comparative immunogenicity and
effectiveness of mRNA–1273, BNT162b2
and Ad26.COV2.S COVID–19 vaccines.
medRxiv preprint. https://doi.org/
10.1101/2021.07.18.21260732.
(Naranbhai et al., October 13, 2021)
National Cancer Institute (NCI). (2015, April
29). Age and Cancer Risk. https://
www.cancer.gov/about-cancer/causes-
prevention/risk/age. (NCI, April 29,
2015)
National Institutes of Health (NIH). (2021,
October 12). Coronavirus Disease 2019
(COVID–19) Treatment Guidelines.
https://files.covid19treatmentguidelines.
nih.gov/guidelines/covid19treatment
guidelines.pdf. (NIH, October 12, 2021)
National Insitute of Neurological Disorders
and Stroke (NINDS). (2021, September
2). Coronovirus and the Nervous System.
https://www.ninds.nih.gov/Current-
Research/Coronavirus-and-NINDS/
nervous-system#complications. (NINDS,
September 2, 2021)
Nishiura H et al. (2020, April 16). Closed
environments facilitate secondary
transmission of coronavirus disease
2019. medRxiv preprint. https://doi.org/
10.1101/2020.02.28.20029272. (Nishiura
et al., April 16, 2020)
North Carolina Department of Health and
Human Services (NCDHHS). (2021,
August 30). COVID–19 Clusters in North
Carolina. https://covid19.ncdhhs.gov/
media/725/download. (NCDHHS, August
30, 2021)
Occupational Safety and Health
Administration (OSHA). (2021c,
October). Health Impacts of the COVID–
19 Vaccination and Testing ETS. (OSHA,
October 2021c)
Officer Down Memorial Page (ODMP) (2021,
September 14). 2021 Honor Roll of
Heroes. https://www.odmp.org/search/
year/2021. (ODMP, September 14, 2021).
(ODMP, September 14, 2021)
Oregon Health Authority (OHA) (2021,
September 1). COVID–19 Weekly
Outbreak Report—September 1, 2021.
https://www.oregon.gov/oha/covid19/
Documents/DataReports/Weekly-
Outbreak-COVID-19-Report-2021-09-01-
FINAL.pdf?utm_medium=email&utm_
source=govdelivery. (OHA, September 1,
2021)
Ortaliza J et al. (2021, August 27). COVID–
19 continues to be a leading cause of
death in the U.S. in August 2021.
Peterson-KFF Health System Tracker.
https://www.healthsystemtracker.org/
brief/covid-19-continues-to-be-a-leading-
cause-of-death-in-the-u-s-in-august-
2021/. (Ortaliza et al., August 27, 2021)
Pascall DJ et al. (2021, August 24). The
SARS–CoV–2 Alpha variant causes
increased clinical severity of disease.
medRxiv preprint. https://doi.org/
10.1101/2021.08.17.21260128. (Pascall et
al., August 24, 2021)
Pasco RF et al. (2020, October 29). Estimated
association of construction work with
risks of COVID–19 infection and
hospitalization in Texas. JAMA Network
Open 3(10): e2026373. doi:10.1001/
jamanetworkopen.2020.26373. (Pasco et
al., October 29, 2020)
Pilz S et al. (2021, February 11). SARS–CoV–
2 re-infection risk in Austria. Eur J Clin
Invest, 2021. 51(4): p. e13520.
doi:10.1111/eci.13520. (Pilz et al.,
February 11, 2021)
Planas D et al. (2021, August 12). Reduced
sensitivity of SARS_CoV–2 variant Delta
to antibody neutralization. Nature 596:
276–280. doi:10.1038/s41586–021–
03777–9. (Planas et al., August 12, 2021)
Porter KA et al. (2021, April 30). COVID–19
among workers in the seafood processing
industry: Implications for prevention
measures—Alaska, March-October 2020.
MMWR Morb Mortal Wkly Rep; 70: 622–
626. https://www.cdc.gov/mmwr/
volumes/70/wr/mm7017a4.htm. (Porter
et al., April 30, 2021)
Pouwels KB et al. (2021, October 14). Effect
of Delta variant on viral burden and
vaccine effectiveness against new SARS–
CoV–2 infections in the UK. Nat Med
(2021). https://doi.org/10.1038/s41591-
021-01548-7. (Pouwels et al., October 14,
2021)
Pray IW et al. (2021, January 29). Trends in
Outbreak-Associated Cases of COVID–
19—Wisconsin, March–November 2020.
MMWR Morb Mortal Wkly Rep. 70(4):
114–117. doi:10.15585/
mmwr.mm7004a2. Erratum in: MMWR
Morb Mortal Wkly Rep. 2021 Feb 05;
70(5): 183. (Pray et al., January 29, 2021)
Psichogiou M et al. (2021, September 13).
Comparative Immunogenicity of
BNT162b2 mRNA Vaccine with Natural
SARS–CoV–2 Infection. Vaccines
9(1017). doi:10.3390/vaccines9091017.
(Psichogiou et al., September 13, 2021)
Public Health England. (2020, December 18).
Factors contributing to risk of SARS–
CoV–2 transmission associated with
various settings. https://www.gov.uk/
government/publications/phe-factors-
contributing-to-risk-of-SARS-cov2-
transmission-in-various-settings-26-
november-2020. (Public Health England,
December 18, 2020)
Qian et al. (2020, October 27). Indoor
transmission of SARS–CoV–2. Indoor Air
31: 639–645. doi:10.1111/ina.12766.
(Qian et al., October 27, 2020)
Riemersma KK et al. (2021, July 31).
Vaccinated and unvaccinated
individuals have similar viral loads in
communities with a high prevalence of
the SARS_CoV–2 delta variant. medRxiv
preprint. https://doi.org/10.1101/
2021.07.31.21261387. (Riemersma et al.,
July 31, 2021)
Riou J and Althaus CL. (2020, January 30).
Pattern of early human-to-human
transmission of Wuhan 2019 novel
coronavirus (2019-nCoV), December
2019 to January 2020. Eurosurveillance
25(4): pii=2000058. https://doi.org/
10.2807/1560-
7917.ES.2020.25.4.2000058. (Riou and
Althaus, January 30, 2020)
Rosenberg ES et al. (2021, August 27). New
COVID–19 Cases and Hospitalizations
Among Adults, by Vaccination Status—
New York, May 3–July 25, 2021. MMWR
Morb Mortal Wkly Rep 2021; 70(34):
1150–1155. https://www.cdc.gov/mmwr/
volumes/70/wr/mm7034e1.htm.
(Rosenberg et al., August 27, 2021)
Rosenthal N et al. (2020, December 10). Risk
Factors Associated With In-Hospital
Mortality in a US National Sample of
Patients With COVID–19. JAMA Netw
Open. 2020 Dec 1; 3(12): e2029058.
doi:10.1001/
jamanetworkopen.2020.29058.
(Rosenthal et al., December 10, 2020)
Saciuk Y et al. (2021, June 25). Pfizer-
BioNTech vaccine effectiveness against
SARS_CoV–2 infection: Findings from a
large observational study in Israel.
Lancet preprint. https://papers.ssrn.com/
sol3/papers.cfm?abstract_id=3868853.
(Saciuk et al., June 25, 2021)
Sami S et al. (2021, March). Prevalence of
SARS–CoV–2 antibodies in first
responders and public safety personnel,
New York City, New York, USA, May–
July 2020. Emerging Infectious Diseases,
27(3), 796–804. https://doi.org/10.3201/
eid2703.204340. (Sami et al., March
2021)
Sami S et al. (2021, April 9). Community
Transmission of SARS–CoV–2
Associated with a Local Bar Opening
Event—Illinois, February 2021. MMWR
Morb Mortal Wkly Rep. 70(14): 528–532.
doi:10.15585/mmwr.mm7014e3. (Sami et
al., April 9, 2021)
Scobie HM et al. (2021, September 17).
Monitoring Incidence of COVID–19
Cases, Hospitalizations, and Deaths, by
Vaccination Status—13 U.S.
Jurisdictions, April 4–July 17, 2021.
MMWR Morb Mortal Wkly Rep 2021; 70:
early release. https://www.cdc.gov/
mmwr/volumes/70/wr/mm7037e1.htm.
(Scobie et al., September 17, 2021)
Self WH et al. (2021, September 17).
Comparative effectiveness of Moderna,
Pfizer-BioNTech, and Janssen (Johnson
and Johnson) vaccines in preventing
COVID–19 hospitalizations among adults
without immunocompromising
conditions—United States, March–
August 2021. MMWR Morb Mortal Wkly
Rep 2021; 70: early release. https://
www.cdc.gov/mmwr/volumes/70/wr/
mm7038e1.htm. (Self et al., September
17, 2021)
Seppala E et al. (2021, September 2). Vaccine
effectiveness against infection with the
Delta (B.1.617.2) variant, Norway, April
to August 2021. 26(35): 1–7. doi:10.2807/
1560-7917.ES.2021.26.35.2100793.
(Seppala et al., September 2, 2021)
Shah ASV et al. (2021, September 10). Effect
of Vaccination on Transmission of
SARS–CoV–2. N Enf J Med. doi:10.1056/
NEJMc2106757. (Shah et al., September
10, 2021)
Sheehan MM et al. (2021, March 15).
Reinfection rates among patients who
previously tested positive for COVID–19:
A retrospective cohort study. Clin Infect
Dis, 2021. doi:10.1093/cid/ciab234.
(Sheehan et al., March 15, 2021)
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Sheikh A et al. (2021, June 4). SARS–CoV–
2 Delta VOC in Scotland: Demographics,
risk of hospital admission, and vaccine
effectiveness. The Lancet. 2021;
397(10293): 2461–2462. doi:10.1016/
s0140–6736(21)01358–1. (Sheikh et al.,
June 4, 2021)
Shenai MB et al. (2021, September 21).
Equivalency of protection from natural
immunity in COVID–19 recovered versus
fully vaccinated persons: A systematic
review and pooled analysis. medRxiv
preprint. doi:10.1101/
2021.09.12.21263461. (Shenai et al.,
September 21, 2021)
Shrestha NK et al. (2021, June 19). Necessity
of COVID–19 vaccination in previously
infected individuals. medRxiv preprint.
doi:10.1101/2021.06.01.21258176.
(Shrestha et al., June 19, 2021)
Singanayagam A et al. (2021, September 6).
Community transmission and viral load
kinetics of SARS–CoV–2 Delta
(B.1.617.2) variant in vaccinated and
unvaccinated individuals. Lancet
preprint. doi:10.2139/ssrn.3918287.
(Singanayagam et al., September 6, 2021)
Spencer J and and Jewett C. (2021, April 8).
Lost on the Frontline. 12 months of
Trauma: More than 3,600 US health
workers died in COVID’s first year.
https://khn.org/news/article/us-health-
workers-deaths-covid-lost-on-the-
frontline/. (Spencer and Jewett, April 8,
2020)
Steinberg J et al. (2020, August 7). COVID–
19 Outbreak among employees at a meat
processing facility — South Dakota,
March–April 2020. MMWR Morb Mortal
Wkly Rep 69: 1015–1019. doi: http://
dx.doi.org/10.15585/mmwr.mm6931a2.
(Steinberg et al., August 7, 2020)
Suhs T et al. (2021, July 23). COVID–19
Outbreak Associated with a Fitness
Center—Minnesota, September–
November 2020. Clin Infect Dis. 2021 Jul
23: ciab653. doi:10.1093/cid/ciab653.
Epub ahead of print. (Suhs et al., July 23,
2021)
Taylor et al. (2021, October 22). Severity of
Disease Among Adults Hospitalized with
Laboratory-Confirmed COVID–19 Before
and During the Period of SARS–CoV–2
B.1.617.2 (Delta) Predominance—
COVID–NET, 14 States, January–August
2021. MMWR Early Release/October 22,
2021/70. https://www.cdc.gov/mmwr/
volumes/70/wr/mm7043e1.htm. (Taylor
et al., October 22, 2021).
Tennessee Department of Health (TDH).
(2021, September 8). COVID–19 critical
indicators. https://www.tn.gov/content/
dam/tn/health/documents/cedep/novel-
coronavirus/CriticalIndicatorReport.pdf.
(TDH, September 8, 2021)
Twohig K et al. (2021, August 27). Hospital
admission and emergency care
attendance risk for SARS–CoV–2 delta
(B.1.617.2) compared with alpha
(B.1.1.7) variants of concern: A cohort
study. The Lancet Infectious Disease.
https://doi.org/10.1016/S1473-
3099(21)00475–8. (Twohig et al., August
27, 2021)
University of California San Diego (UCSD).
(2021). Better Primary Care for You and
Your Family. https://health.ucsd.edu/
specialties/primary-care/Pages/
default.aspx. (UCSD, 2021)
Vekaria et al. (2021, July 22). Hospital length
of stay for COVID–19 patients: Data-
driven methods for forward planning.
BMC Infect Dis 21, 700 (2021). https://
doi.org/10.1186/s12879-021-06371-6.
(Vekaria et al., July 22, 2021)
Vitale J et al. (2021, May 28). Assessment of
SARS–CoV–2 refinfection 1 year after
primary infection in a population in
Lombardy, Italy. JAMA Intern Med,
2021. doi:10.1001/
jamainternmed.2021.2959. (Vitale et al.,
May 28, 2021)
Vrangbaek K et al. (2021, April 29).
Transition Measures: Testing. COVD–19
Health System Response Monitor:
Denmark. https://
www.covid19healthsystem.org/countries/
denmark/livinghit.aspx?Section=
1.5%20Testing&Type=Section.
(Vrangbaek et al., April 29, 2021)
Wallace M et al. (2020, May 15). COVID–19
in Correctional and Detention
Facilities—United States, February–
April 2020. MMWR 69: 587–590. http://
dx.doi.org/10.15585/mmwr.mm6919e1.
(Wallace et al., May 15, 2020)
Waltenburg MA et al. (2021, January).
Coronavirus disease among workers in a
food processing, food manufacturing,
and agriculture workplaces. Emerg Infect
Dis 27(1): 243–249. https://
wwwnc.cdc.gov/eid/article/27/1/20–
3821_article. (Waltenburg et al., January
2021)
Wang Z et al. (2021, July 15). Naturally
enhanced neutralizing breadth against
SARS_CoV–2 one year after infection.
Nature 595: 426–431. doi:10.1038/
s41586–021–03696–9. (Wang et al., July
15, 2021)
Ward JA et al. (2021, June). COVID–19 cases
among employees of U.S. federal and
state prisons. Am J Prev Med. 60(6): 840–
844. doi:10.1016/j.amepre.2021.01.018.
Epub 2021 Feb 22. (Ward et al., June,
2021)
Washington State Department of Health
(WSDH). (2021, September 8). Statewide
COVID–19 outbreak report. (WSDH,
September 8, 2021)
Weed M and Foad A. (2020, September 10).
Rapid Scoping Review of Evidence of
Outdoor Transmission of COVID–19.
medRxiv preprint. doi:10.1101/
2020.09.04.20188417. (Weed and Foad,
September 10, 2020)
Wei J et al. (2021, July 5). Anti-spike
antibody response to natural SARS–
CoV–2 infection in the general
population. medRxiv preprint.
doi:10.1101/2021.07.02.21259897. (Wei
et al., July 5, 2021)
Williams SV et al. (2021, July 8). An outbreak
caused by the SARS–CoV–2 Delta
(B.1.617.2) variant in a care home after
partial vaccination with a single dose of
the COVID–19 vaccine Vaxzevria,
London, England, April 2021. Euro
Surveill. 26(27): 2100626. doi:10.2807/
1560–7917.ES.2021.26.27.2100626.
(Williams et al., July 8, 2021)
Wingate K. (2021, September 24). Five dead
and 74 infected after COVID–19 outbreak
in Washington nursing home. USA
Today. https://www.usatoday.com/story/
news/nation/2021/09/24/covid-outbreak-
nursing-home-washington-kills-infects-
dozens/5848804001/. (Wingate,
September 24, 2021)
Young-Xu Y et al. (2021, July 14). Coverage
and effectiveness of mRNA COVID–19
vaccines among veterans. medRxiv
preprint. doi:10.1101/
2021.06.14.21258906. (Young-Xu et al.,
July 14, 2021)
B. Need for the ETS
This ETS is necessary to protect
unvaccinated workers from the risk of
contracting COVID–19, including its
more contagious variants, such as the
B.1.617.2 (Delta), at work. The rule
protects workers through the most
effective and efficient workplace control
available: Vaccination. Additionally,
this ETS is necessary to protect workers
who remain unvaccinated through
required regular testing, use of face
coverings, and removal of infected
employees from the workplace.
I. Events Leading to the ETS
This section describes the evolution
of OSHA’s actions to protect employees
from the grave danger posed by COVID–
19 and the agency’s reasons for issuing
this ETS at this time.
a. OSHA’s 2020 Actions Regarding
COVID–19
Beginning in early 2020, OSHA began
to monitor the growing cases of the
SARS–CoV–2 virus that were occurring
around the country. Because scientific
information about the disease, its
potential duration, and ways to mitigate
it were undeveloped, OSHA decided to
monitor the situation. As noted below,
OSHA subsequently issued numerous
guidance documents advising interested
employers of steps they could take to
mitigate the hazard arising from the
virus.
Also beginning in early 2020, OSHA
received numerous petitions and
supporting letters from members of
Congress, unions, advocacy groups, and
one group of large employers urging the
agency to take immediate action by
issuing an ETS to protect employees
from exposure to the virus that causes
COVID–19 (Scott and Adams, January
30, 2020; NNU, March 4, 2020; AFL–
CIO, March 6, 2020; Menendez et al.,
March 9, 2020; Wellington, March 12,
2020; DeVito, March 12, 2020; Carome,
March 13, 2020; SMART, March 30,
2020; Blumenthal et al., April 8, 2020;
Murray et al., April 29, 2020; Luong,
April 30, 2020; Novoa, June 24, 2020;
Solt, April 28, 2020; Castro et al., April
29, 2020; Talbott and Adely, May 4,
2020; Public Citizen, March 13, 2020;
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16 This adoption includes the citations in the
referenced section of the Healthcare ETS, which are
also included in the docket for this ETS.
LULAC, March 31, 2020; Meuser, May
1, 2020; Raskin, April 29, 2020;
Cartwright et al., May 7, 2020; Frosh et
al., May 12, 2020; Pellerin, March 19,
2020; Yborra, March 19, 2020; Owen,
March 19, 2020; Brown et al., April 30,
2020; Price et al., May 1, 2020;
ORCHSE, October 9, 2020). These
petitions and supporting letters argued
that many employees had been infected
because of workplace exposures to the
virus that causes COVID–19, and that
immediate, legally enforceable action is
necessary for protection. OSHA quickly
began issuing detailed guidance
documents and alerts beginning in
March 2020 that helped employers to
determine employee risk levels of
COVID–19 exposure and made
recommendations for appropriate
controls. As explained in detail in
Section IV. of the Healthcare ETS, 86 FR
32376, 32412–13 (June 21, 2021) and
hereby included in the record for this
ETS,16 at the time, OSHA leadership
believed that implementing a
combination of enforcement tools,
including guidance, existing OSHA
standards, and the General Duty Clause,
would provide the necessary protection
for workers. OSHA also expressed
concern that an ETS might
unintentionally enshrine requirements
that are subsequently proven ineffective
in reducing transmission.
When it decided not to issue an ETS
in the spring of 2020, OSHA determined
that the agency could provide sufficient
employee protection against COVID–19
through enforcing existing workplace
standards and the General Duty Clause
of the OSH Act, coupled with issuing
industry-specific, non-mandatory
guidance. However, in doing so OSHA
indicated that its conclusion that an
ETS was not necessary was specific to
that time, and that the agency would
continue to monitor the situation and
take additional steps as appropriate (see,
e.g., OSHA, March 18, 2020 Letter to
Congressman Scott (stating ‘‘[W]e
currently see no additional benefit from
an ETS in the current circumstances
relating to COVID–19. OSHA is
continuing to monitor this quickly
evolving situation and will take the
appropriate steps to protect workers
from COVID–19 in coordination with
the overall U.S. government response
effort.’’ (emphasis supplied); DOL May
29, 2020 at 20 (stating ‘‘OSHA has
determined this steep threshold [of
necessity] is not met here, at least not
at this time.’’ (emphasis supplied))).
In addition to the various petitions for
rulemaking that were submitted to
OSHA, the AFL–CIO filed a petition for
a writ of mandamus with the U.S. Court
of Appeals for the D.C. Circuit,
requesting that the court compel OSHA
to issue an ETS. (AFL–CIO, May 18,
2020). In its administrative decision and
filing in that case, OSHA explained that
the determination not to issue an ETS
was based on the conditions and
information available to the agency at
that time and was subject to change as
additional information indicated the
need for an ETS. On June 11, 2020, the
U.S. Court of Appeals for the D.C.
Circuit issued a one paragraph per
curiam order denying the AFL–CIO’s
petition to require OSHA to issue an
ETS. To be clear, nothing in OSHA’s
prior position or the D.C. Circuit’s
decision in In re Am. Fed’n of Labor &
Cong. of Indus. Orgs., No. 20–1158,
2020 WL 3125324 (D.C. Cir. June 11,
2020); rehearing en banc denied (July
28, 2020) precludes OSHA’s decision to
promulgate an ETS now. To the
contrary, at an early phase of the
pandemic, when vaccines were not yet
available and when it was not yet
known how extensive the impact would
be on illness and death, the court
decided not to second-guess OSHA’s
decision to hold off on regulation in
order to see if its nonregulatory
enforcement tools could be used to
provide adequate protection against the
virus. ‘‘OSHA’s decision not to issue an
ETS is entitled to considerable
deference,’’ the court explained, noting
‘‘the unprecedented nature of the
COVID–19 pandemic’’ and concluding
merely that ‘‘OSHA reasonably
determined that an ETS is not necessary
at this time.’’ (Id., with emphasis
added).
Employers do not have a reliance
interest in OSHA’s prior decision not to
issue an ETS on May 29, 2020, which
did not alter the status quo or require
employers to change their behavior. See
Dep’t of Homeland Security v. Regents
of the Univ. of California, 140 S. Ct.
1891, 1913–14 (2020). As OSHA
indicated when it made the decision,
the determination was based on the
conditions and information available to
the agency at that time and was subject
to change as additional information
indicated the need for an ETS. In light
of the agency’s express qualifications
and the surrounding context, any
employer reliance would have been
unjustified and cannot outweigh the
countervailing urgent need to protect
workers covered by this ETS from the
grave danger posed by COVID–19.
b. OSHA’s Decision To Promulgate a
Healthcare ETS
OSHA subsequently issued the
Healthcare ETS to protect healthcare
workers. 86 FR 32376. (June 21, 2021),
codified at 29 CFR 1910.502. Looking
back on a year of experience, OSHA
found that its enforcement efforts had
encountered significant obstacles,
demonstrating that existing standards,
regulations, and the General Duty
Clause were inadequate to address the
grave danger faced by healthcare
employees. 86 FR 32415. In
promulgating that ETS, OSHA
recognized that ‘‘the impact of [COVID–
19] has been borne disproportionately
by the healthcare and healthcare
support workers tasked with caring for
those infected by this disease.’’ 86 FR
32377. Furthermore, states and localities
had taken increasingly divergent
approaches to workplace protections
against COVID–19, making it clear that
a federal standard was needed to ensure
sufficient protection in all states. 86 FR
32377. Therefore, OSHA focused on the
unique situation experienced by
healthcare industry workers as the
frontline caregivers and support workers
for those suffering from COVID–19. See
86 FR 32376, 32411–12.
The Healthcare ETS requires
employers to institute a suite of
engineering controls, administrative
controls, work practices, and personal
protective equipment to combat the
COVID–19 hazard. In the Preamble to
the Healthcare ETS, OSHA observed
that the development of safe and highly
effective vaccines is a critical milestone
in the nation’s response to COVID–19,
and that fully vaccinated persons have
a greatly reduced risk of death,
hospitalization and other health
consequences. 86 FR 32396. The
Healthcare ETS therefore includes
provisions intended to encourage
employees to become vaccinated,
including a requirement for employers
to provide reasonable paid leave for
vaccination and recovery from any side
effects. 86 FR 32415, 29 CFR
1910.502(m).
In the Healthcare ETS OSHA found
that employees who work in covered
healthcare workplaces are exposed to
grave danger. 86 FR 32411. The agency
also stated that in light of the
effectiveness of vaccines, there was
‘‘insufficient evidence in the record to
support a grave danger finding for non-
healthcare workplaces where all
employees are vaccinated.’’ 86 FR 32396
(emphasis supplied). OSHA made no
finding at that time regarding
unvaccinated workers in non-healthcare
workplaces.
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No employer challenged the
Healthcare ETS in court. The United
Food and Commercial Workers Union
(UFCW) together with the AFL–CIO
filed a petition for review asserting that
the rule should have gone further and
included more industries in its scope
(UFCW and AFL–CIO, June 24, 2021).
That case is being held in abeyance
pending the issuance of this ETS.
c. Subsequent Developments
The preamble to the Healthcare ETS
notes that new COVID–19 variants
might emerge that are more
transmissible and cause more severe
illness, but does not specifically
mention the Delta Variant. See 86 FR
32384. Since publication of the
Healthcare ETS, the Delta Variant has
become the dominant form of the virus
in the United States, causing large
spikes in transmission, and surges of
hospitalizations, and deaths,
overwhelmingly among the
unvaccinated (CDC, August 26, 2021;
CDC, October 18, 2021—Variant
Proportions, July Through October,
2021). As discussed in more detail in
Grave Danger (Section III.A. of this
preamble), the Delta Variant is at least
twice as contagious as previous COVID–
19 variants, and research suggests that it
also causes more severe illness in the
unvaccinated population (CDC, August
26, 2021). More infections mean more
potential for exposures, including in
workplaces (see Grave Danger, Section
III.A. of this preamble, for further
discussion on workplace outbreaks,
clusters, and the general impact of
transmission in the workplace.). More
infections also mean more opportunities
for the virus to undergo mutations to its
genetic code, resulting in genetic
variants with the potential to infect or
re-infect people.
Some variability in infection rates in
a pandemic is to be expected. While the
curves of new infections and deaths can
bend down after peaks, they often
reverse course only to reach additional
peaks in the future (Moore et al., April
30, 2020). Last year experts expressed
concern that one or more subsequent
waves of COVID–19 were possible in
2021 (Moore et al., April 30, 2020),
especially with new variants of COVID–
19 in circulation (Doughton, February 9,
2021). That potential tragically became
a reality with the spread of the Delta
Variant.
In June 2021, when the Healthcare
ETS was published, COVID–19
transmission rates in the United States
were at a low point, with the 7-day
moving average of reported cases to be
about 12,000. (CDC, August 26, 2021)
However, by the end of July, the 7-day
moving average reached over 60,000 as
the Delta Variant spread across the
country. (CDC, August 26, 2021). The 7-
day moving average of reported cases at
the beginning of September, 2021
exceeded 161,000 (CDC, October 18,
2021—Daily Cases). The most recent 7-
day moving average of reported cases,
while lower than the peak in late
August and early September, is still over
85,000. (CDC, October 18, 2021—Daily
Cases). These rates are also far higher
than the rate when OSHA first declined
to issue an ETS. (CDC, August 27, 2020
(20,401 confirmed cases per day on May
29, 2020)). The jump in infections has
resulted in increased hospitalizations
and deaths for unvaccinated workers, as
discussed in detail in Grave Danger
(Section III.A. of this preamble). While
the most current data reflect a decline
in new cases from the peak, the level of
new cases remains high. CDC data
shows that, as of October 18, 2021,
approximately 85% of U.S. counties
were experiencing ‘‘high’’ rates of
community transmission, and another
10% were experiencing ‘‘substantial’’
community transmission (CDC, October
18, 2021—Daily Cases). Although the
number of new detected cases is
currently declining nationwide (see
CDC, October 18, 2021—Community
Transmission Rates), the agency cannot
assume based on past experience that
nationwide case levels will not increase
again. Indeed, many northern states are
currently experiencing increases in their
rate of new cases (see CDC, October 18,
2021—Cases, Deaths, and Laboratory
Testing (NAATS) by State; Slotnik,
October 18, 2021), including Vermont,
which set a new record for new COVID–
19 cases in mid-October 2021 (Murray,
October 18, 2021). Unless vaccination
rates increase, the experience of
northern states during this fall could
presage a greater resurgence in cases
this winter as colder weather drives
more individuals indoors (see Firozi
and Dupree, October 18, 2021).
While it is important to recognize that
the Delta Variant has caused a spike in
hospitalization and death in the United
States, the SARS–CoV–2 virus, and not
just a particular variant of that virus, is
the hazard that workers face (see Grave
Danger, Section III.A. of this preamble).
Like any virus, SARS–CoV–2 has the
ability to mutate over time and produce
variants that may be more or less severe.
Indeed, the World Health Organization
and the CDC both track new variants
that have continued to arise, such as the
Lamda and Mu Variants (WHO, October
12, 2021; CDC, October 4, 2021). At this
time, the CDC is tracking 11 different
variants of COVID–19 (CDC, October 4,
2021). The World Health Organization
has classified the Lambda and Mu
variants as ‘‘variants of interest,’’
meaning that they have genetic changes
that affect transmissibility, disease
severity, immune escape, diagnostic or
therapeutic escape; and have been
identified to cause significant
community transmission or multiple
COVID–19 clusters, in multiple
countries with increasing relative
prevalence alongside increasing number
of cases over time, or other apparent
epidemiological impacts to suggest an
emerging risk to global public health
(WHO, October 12, 2021). Medical
experts have also explained that
vaccination reduces the opportunities
for the virus to continue to mutate by
reducing transmission and length of
infection. And, there is no indication
that future variants of COVID–19 will
not be equally or even more dangerous
than Delta without a higher rate of
vaccination (Bollinger and Ray, July 23,
2021).
Meanwhile, evidence on the power of
vaccines to safely protect individuals
from infection and especially from
serious disease has continued to
accumulate. (CDC, May 21, 2021). For
example, as explained in more detail in
Grave Danger (Section III.A. of this
preamble), multiple studies have
demonstrated that vaccines are highly
effective at reducing instances of
hospitalization and death. In September
the CDC compiled data from various
studies that demonstrated overall
authorized vaccines reduced death and
severe case rates by 91 and 92%
respectively in the population studied
between April and July (Scobie et al.,
September 17, 2021, Table 1.).
Additionally, the FDA granted approval
to the Pfizer-BioNTech COVID–19
Vaccine for individuals 16 years of age
and older on August 23, 2021 (FDA,
August 23, 2021). In announcing the
decision, the FDA Commissioner
explained that ‘‘[w]hile this and other
vaccines have met the FDA’s rigorous,
scientific standards for emergency use
authorization, as the first FDA-approved
COVID–19 vaccine, the public can be
very confident that this vaccine meets
the high standards for safety,
effectiveness, and manufacturing quality
the FDA requires of an approved
product.’’ (FDA, August 23, 2021.)
Despite this important milestone, and
the demonstrated effectiveness of the
approved and authorized vaccines
available to the public, millions of
employees remain unvaccinated,
approximately 39% of workers who are
covered by this ETS (See Economic
Analysis, Section IV.B. of this ETS). The
rate of vaccination in the United States
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has slowed significantly from its peak in
April, when the daily number of
vaccination doses administered
exceeded three million at one point. In
recent months, daily vaccination rates
have hovered around one million doses
administered, or lower (CDC, October
18, 2021—Daily Vaccination Rate). The
shortfall in vaccination leaves the
nation’s working population vulnerable
to sickness, hospitalization and death,
whether today under the Delta Variant,
or under future variants that may arise
(CDC, October 18, 2021—Daily
Vaccination Rate); see also Grave Danger
(Section III.A. of this preamble).
Moreover, in recent months, an
increasing number of states have
promulgated Executive Orders or
statutes that prohibit workplace
vaccination policies that require
vaccination or proof of vaccination
status, thus attempting to prevent
employers from implementing the most
efficient and effective method for
protecting workers from the hazard of
COVID–19 (see, e.g., Texas Executive
Order GA–40, October 11, 2021;
Montana H.B. 702, July 1, 2021;
Arkansas S.B. 739, October 4, 2021 and
Arkansas H.B. 1977, October 1, 2021;
AZ Executive Order 2021–18, August
16, 2021). While some States’ bans have
focused on preventing local
governments from requiring their public
employees to be vaccinated or show
proof of vaccination, the Texas,
Montana, and Arkansas requirements
apply to private employers as well.
Other states have banned local
ordinances that require employers to
ensure that customers who enter their
premises wear masks, thus endangering
the employees who work there,
particularly those who are unvaccinated
(see, e.g., Florida Executive Order 21–
102, May 3, 2021; Texas Executive
Order GA–34, March 2, 2021).
In short, at the present time, workers
are becoming sick and dying
unnecessarily as a result of occupational
exposures, when there is a simple and
effective measure, vaccination, that can
largely prevent those deaths and
illnesses (see Grave Danger, Section
III.A. of this preamble). Congress
charged OSHA with responsibility for
issuing emergency standards when they
are necessary to protect employees from
grave danger. 29 U.S.C. 655(c). In light
of the current situation, OSHA is issuing
this emergency rule.
References
American Federation of Labor and Congress
of Industrial Organizations (AFL–CIO).
(2020, March 6). ‘‘To Address the
Outbreak of COVID–19: A Petition for an
OSHA Emergency Temporary Standard
for Infectious Disease.’’ (AFL–CIO,
March 6, 2020)
American Federation of Labor and Congress
of Industrial Organizations (AFL–CIO).
(2020, May 18). ‘‘Emergency Petition For
A Writ Of Mandamus, and Request For
Expedited Briefing And Disposition, No.
19–1158.’’ (AFL–CIO, May 18, 2020)
An Act Prohibiting Discrimination Based on
a Person’s Vaccination Status or
Possession of an Immunity Passport;
Montana H.B. 702. (2021, July 1). https://
leg.mt.gov/bills/2021/billpdf/
HB0702.pdf. (Montana H.B. 702 July 1,
2021)
Arizona Executive Order 2021–18. (2021,
August 16). https://azgovernor.gov/sites/
default/files/eo_2021-18.pdf. (AZ
Executive Order 2021–18, August 16,
2021)
Arkansas H.B. 1977. (2021, October 1). To
Provide Employee Exemptions From
Federal Mandates and Employer
Mandates Related to Coronavirus 2019
(COVID–19); and to Declare an
Emergency. https://
www.arkleg.state.ar.us/Bills/
FTPDocument?path=%2
FAMEND%2F2021R%2FPublic
%2FHB1977–H1.pdf. (Arkansas H.B.
1977, October 1, 2021)
Arkansas S.B. 739. (2021, October 4). An Act
Concerning Employment Issues Related
to Coronavirus 2019 (COVID–19); To
Provide Employee Exemptions From
Federal Mandates and Employer
Mandates Related to Coronavirus 2019
(COVID–19); To Declare and Emergency;
and For Other Purposes. https://
www.arkleg.state.ar.us/Bills/
FTPDocument?path=%2
FBills%2F2021R%2
FPublic%2FSB739.pdf. (Arkansas S.B.
739, October 4, 2021)
Blumenthal R, Murray P, Duckworth T, Casey
RP, Baldwin B, Brown S, Menendez R.
(2020, April 8). ‘‘COVID–19 ETS
Petition.’’ (Blumenthal et al., April 8,
2020)
Bollinger R and Ray R. (2021, July 23). New
Variants of the Coronavirus: What You
Should Know. Johns Hopkins Medicine.
https://www.hopkinsmedicine.org/
health/conditions-and-diseases/
coronavirus/a-new-strain-of-coronavirus-
what-you-should-know. (Bollinger and
Ray, July 23, 2021)
Brown S, Murray P, Baldwin T, Bennet MF,
Casey Jr. RP, Whitehouse S, Hirono MK,
Blumenthal R, Van Hollen C, Masto CC,
Sanders B, Reed J, Harris KD, Wyden R,
Durbin RJ, Booker CA, Warren E, Leahy
PJ. (2020, April 30). ‘‘COVID–19 ETS
Petition.’’ (Brown et al., April 30, 2020)
Carome M. (2020, March 13). ‘‘Letter
requesting an immediate OSHA
emergency temporary standard for
infectious disease.’’ (Carome, March 13,
2020)
Cartwright M, Kaptur M, Roybal-Allard L,
Foster B. (2020, May 7). ‘‘COVID–19 ETS
Petition.’’ (Cartwright et al., May 7, 2020)
Castro J, Espaillat A, Ca´rdenas T, Ocasio-
Cortez A, Sablan GKC, Garcia J, Gallego
R, Escobar V, Vargas J, Trahan L, Torres
NJ, Correa L, Barraga´n ND, Serrano JE,
Cisneros Jr. GR, Napolitano GF,
Velazquez NM, Garcia SR, Grijalva R.
(2020, April 29). ‘‘COVID–19 ETS
Petition.’’ (Castro et al., April 29, 2020)
Centers for Disease Control and Prevention
(CDC). (2020, August 27). Previous U.S.
Covid-19 Case Data. https://
www.cdc.gov/coronavirus/2019-ncov/
covid-data/previouscases.html. (CDC,
August 27, 2020)
Centers for Disease Control and Prevention
(CDC). (2021, May 21). Interim Estimates
of Vaccine Effectivness of Pfizer-
BioNTech and Moderna COVID–19
Vaccines Among Health Care
Personnel—33 U.S. Sites, January–March
2021. https://www.cdc.gov/mmwr/
volumes/70/wr/mm7020e2.htm. (CDC,
May 21, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, August 26). Delta Variant:
What We Know About the Science.
https://www.cdc.gov/coronavirus/2019-
ncov/variants/delta-variant.html?s_
cid=11512:cdc%20delta
%20variant:sem.ga:p:RG:GM:
gen:PTN:FY21. (CDC, August 26, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, October 4). SARS–CoV–2
Variant Classifications and Definitions.
https://www.cdc.gov/coronavirus/2019-
ncov/variants/variant-info.html. (CDC,
October 4, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, October 18). COVID Data
Tracker. https://covid.cdc.gov/covid-
data-tracker/. (CDC, October 18, 2021)
DeVito J. (2020, March 12). ‘‘Grant OSHA
emergency standard for COVID–19 to
protect frontline workers.’’ (DeVito,
March 12, 2020)
Doughton S. (2021, February 9). Can a fourth
wave of COVID–19 be prevented? Not
likely, says Fred Hutch model—but the
curve could be flattened. The Seattle
Times. https://www.seattletimes.com/
seattle-news/health/can-a-fourth-wave-
of-covid-19-be-prevented-not-likely-says-
fred-hutch-model-but-the-curve-could-
be-flattened/. (Doughton, February 9,
2021)
Firozee P and Dupree J. (2021, October 18).
Coronavirus numbers are dropping. More
vaccinations can prevent a winter surge,
Fauci says. The Washington Post.
https://www.washingtonpost.com/
health/2021/10/18/faucis-americans-
can-prevent-winter-pandemic-surge/.
(Firozee and Dupree, October 18, 2021)
Florida Executive Order 21–102. (2021, May
3). https://www.flgov.com/wp-content/
uploads/orders/2021/EO_21-102.pdf.
(Florida Executive Order 21–102, May 3,
2021)
Food and Drug Administration (FDA) (2021,
August 23). FDA Approves First COVID–
19 Vaccine. https://www.fda.gov/news-
events/press-announcements/fda-
approves-first-covid-19-vaccine. (FDA,
August 23, 2021)
Frosh BE, Becerra X, Weiser PJ, Jennings K,
Racine KA, Raoul K., Frey AM, Healey
M., Nessel D, Ellison K, Ford AD, Grewal
GS, Balderas H, James L, Rosenblum EF,
Shapiro J, Neronha P, Herring MP,
Ferguson B, Kaul JL. (2020, May 12).
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17 As explained in the Grave Danger section, this
ETS focuses on protecting unvaccinated workers
from the grave danger that COVID–19 poses in the
workplace. OSHA did not include fully vaccinated
workers in its finding of grave danger because such
workers are generally much better protected from
the effects of COVID–19, and, in particular, the
most severe effects, than workers who are
unvaccinated. OSHA’s action in adopting this ETS
for unvaccinated workers does not mean that
vaccinated workers do not face a significant risk
from COVID–19, or that the OSH Act’s general duty
clause poses no obligation on employers to protect
their vaccinated workers from COVID–19. Indeed,
symptomatic infections can occur in fully
vaccinated people, and COVID–19 therefore poses
at least some risk to vaccinated workers. OSHA has
requested comment on the risks faced by vaccinated
workers from COVID–19, and what additional
measures, if any, should be taken to protect both
vaccinated and unvaccinated workers (see Request
for Comments, Section I.B. of this preamble).
‘‘COVID–19 ETS Petition.’’ (Frosh et al.,
May 12, 2020)
League of United Latin American Citizens
(LULAC). (2020, March 31). ‘‘COVID–19
ETS Petition.’’ (LULAC, March 31, 2020)
Luong M. (2020, April 30). ‘‘Petition for an
OSHA Emergency Temporary Standard
for Airborne Infectious Diseases.’’
(Luong, April 30, 2020)
Menendez R, Murray P, Baldwin T, Brown S,
Duckworth T, Booker CA, Warren E.
(2020). ‘‘Urge DOL to Direct OSHA to
Issue Comprehensive Emergency
Temporary Standard (ETS) To Protect
Workers Against COVID–19.’’ (Menendez
et al., March 9, 2020)
Meuser D. (2020, May 1). ‘‘COVID–19 ETS
Petition.’’ (Meuser, May 1, 2020)
Moore KA et al. (2020, April 30). COVID–19:
The CIDRAP Viewpoint. Part 1: The
Future of the COVID–19 Pandemic:
Lessons Learned from Pandemic
Influenza. University of Minnesota
Center for Infectious Disease Research
and Policy. https://
www.cidrap.umn.edu/sites/default/files/
public/downloads/cidrap-covid19-
viewpoint-part1_0.pdf. (Moore et al.,
April 30, 2020)
Murray E. (2021, October 18). Vermont sets
new positive COVID daily case record as
delta surge continues. Burlington Free
Press. https://
www.burlingtonfreepress.com/story/
news/local/2021/10/18/covid-vermont-
new-daily-positive-case-record-set/
8505021002/. (Murray, October 18, 2021)
Murray P, Brown S, Heinrich M, Brown S,
Blumenthal R., Markey EJ, Van Hollen C,
Durbin RJ, Smith T, Whitehouse S,
Wyden R, King Jr. AS, Kaine T, Reed J,
Menedez R, Gillibrand K, Duckworth T,
Warren E, Hassan MW, Casey Jr. RP,
Sanders B, Udall T, Hirono MK, Harris
KD, Feinstein D, Klobuchar A, Booker
CA, Shaheen J, Cardin B. (2020, April
29). ‘‘COVID–19 ETS Petition.’’ (Murray
et al., April 29, 2020)
National Nurses United (NNU). (2020, March
4). ‘‘National Nurses United Petitions
OSHA for an Emergency Temporary
Standard on Emerging Infectious
Diseases in Response to COVID–19.’’
(NNU, March 4, 2020)
Novoa M. (2020, June 24). ‘‘Direct OSHA to
issue an emergency temporary standard
to protect all workers from COVID–19
now!’’ (Novoa, June 24, 2020)
Occupational Safety and Health
Administration (OSHA). Letter from
Loren Sweatt to Congressman Robert C.
‘‘Bobby’’ Scott. (OSHA, March 18, 2020)
ORCHSE Strategies. (2020, October 9).
‘‘Petition to the U.S. Department of
Labor—Occupational Safety and Health
Administration (OSHA) for an
Emergency Temporary Standard (ETS)
for Infectious Disease.’’ (ORCHSE,
October 9, 2020)
Owen M. (2020, March 19). ‘‘Grant OSHA
emergency standard to protect frontline
workers from COVID–19.’’ (Owen, March
19, 2020)
Pellerin C. (2020, March 19). ‘‘Grant OSHA
emergency standard to protect frontline
workers from COVID–19.’’ (Pellerin,
March 19, 2020)
Price D, Pocan M, Schakowsky J, DeLauro
RL. (2020, May 1). ‘‘COVID–19 ETS
Petition.’’ (Price et al., May 1, 2020)
Public Citizen. (2020, March 13). ‘‘Support
for AFL–CIO’s Petition for an OSHA
Emergency Temporary Standard for
Infectious Disease to Address the
Epidemic of Novel Coronavirus Disease.’’
(Public Citizen, March 13, 2020)
Raskin J. (2020, April 29). ‘‘COVID–19 ETS
Petition.’’ (Raskin, April 29, 2020)
Scobie HM et al. (2021, September 17).
Monitoring Incidence of COVID–19
Cases, Hospitalizations, and Deaths, by
Vaccination Status—13 U.S.
Jurisdictions, April 4–July 17, 2021.
MMWR Morb Mortal Wkly Rep 2021; 70:
early release. https://www.cdc.gov/
mmwr/volumes/70/wr/mm7037e1.htm.
(Scobie et al., September 17, 2021)
Scott RC and Adams AS. (2020, January 30).
‘‘Prioritize OSHA’s Work on Infectious
Diseases Standard/Immediate Issue of
Temporary Standard.’’ (Scott and
Adams, January 30, 2020)
Slotnik D. (2021, October 18). Coronavirus
cases rise in the northern U.S. amid
lower temperatures. The New York
Times. https://www.nytimes.com/live/
2021/10/18/world/covid-delta-variant-
vaccine#covid-cases-us-winter. (Slotnik,
October 18, 2021)
International Association of Sheet Metal, Air,
Rail and Transportation Workers
(SMART). (2020, March 30). ‘‘Petition for
Emergency Standards.’’ (SMART, March
30, 2020)
Solt BE. (2020, April 28). ‘‘COVID–19 ETS
Petition’’ (Solt, April 28, 2020)
Talbott R and Adely R. (2020, May 4).
‘‘Rulemaking Petition to the United
States Department of Labor Occupational
Safety and Health Administration.’’
(Talbott and Adely, May 4, 2020)
Texas Executive Order GA–34. (2021, March
2). https://open.texas.gov/uploads/files/
organization/opentexas/EO-GA-34-
opening-Texas-response-to-COVID-
disaster-IMAGE-03-02-2021.pdf. (Texas
Executive Order GA–34, March 2, 2021)
Texas Executive Order GA–40. (2021,
October 11). https://gov.texas.gov/
uploads/files/press/EO-GA-40_
prohibiting_vaccine_mandates_
legislative_action_IMAGE_10-11-
2021.pdf. (Texas Executive Order GA–
40, October 11, 2021)
United Food and Commercial Workers
International Union (UFCW) and
American Federation of Labor and
Congress of Industrial Organizations
(AFL–CIO). (2021, June 24). ‘‘Petition for
Review, filed with the D.C. Circuit on
June 24, 2021.’’ (UFCW and AFL–CIO,
June 24, 2021)
Wellington M. (2020, March 12). ‘‘Grant
OSHA emergency standard for COVID–
19 to protect front-line workers’’
(Wellington, March 12, 2020)
World Health Organization (WHO). (2021,
October 12). Tracking SARS–CoV–2
variants. https://www.who.int/en/
activities/tracking-SARS-CoV-2-variants/
. (WHO, October 12, 2021)
Yborra G. (2020, March 19). ‘‘Grant OSHA
emergency standard to protect frontline
workers from COVID–19.’’ (Yborra,
March 19, 2020)
II. This ETS Is Necessary To Protect
Unvaccinated Employees From Grave
Danger
As explained at length in the
preceding section (Grave Danger,
Section III.A. of this preamble), OSHA
has determined that most unvaccinated
workers across the U.S. economy are
facing a grave danger posed by the
COVID–19 hazard.17 This new hazard
has taken the lives of more than 725,000
people—many of them workers—in the
United States since it was first detected
in this country in early 2020. As the
federal agency tasked with protecting
the safety and health of workers in the
United States, OSHA is required to act
when it finds that workers are exposed
to a grave danger. 29 U.S.C. 655(c)(1).
OSHA now finds that this emergency
temporary standard is necessary to
protect employees who are
unvaccinated. Asbestos Info. Ass’n, 727
F.2d at 423 (‘‘failure to act does not
conclusively establish that a situation is
not an emergency . . . [when there is a
grave danger to workers,] to hold that
because OSHA did not act previously it
cannot do so now only compounds the
consequences of the Agency’s failure to
act.’’). As explained in detail below,
OSHA has determined that vaccination
is the most effective control for abating
the grave danger that unvaccinated
employees face from the COVID–19
hazard. And, for workers who are not
vaccinated, the use of testing, face
coverings, and removal from the
workplace, while not as effective as
vaccination, is still effective and
necessary.
OSHA has determined that the best
method for addressing the grave danger
that COVID–19 poses to unvaccinated
workers is to strongly encourage the use
of the single most effective and efficient
protection available: Vaccination. OSHA
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has long recognized the importance of
vaccinating workers against preventable
illnesses to which they may be exposed
on the job. See 56 FR 64004, 64152 (Dec.
6, 1991) (discussing requirement in
Bloodborne Pathogens standard for
employer to make hepatitis B vaccine
available to any employees with
occupational exposure to blood and
other potentially infectious materials).
As explained in Grave Danger (Section
III.A. of this preamble), COVID–19
vaccines do not completely eliminate
the potential for infection, but
significantly reduce the likelihood of
infection, and in turn, transmission of
the virus to others. Data from clinical
trials for all three vaccines and
observational studies for the two mRNA
vaccines clearly establish that fully
vaccinated persons have a greatly
reduced risk of SARS–CoV–2 infection
compared to unvaccinated individuals
(see FDA, December 11, 2020; FDA,
December 18, 2020; FDA, February 26,
2021).
More importantly, vaccination is the
single most effective method for
protecting workers from the most
serious consequences of a COVID–19
infection: Hospitalization and death.
Although symptomatic infections can
occur in fully vaccinated people, they
are less likely to occur, and are far less
likely to result in severe health
outcomes or death. As discussed in
Grave Danger (Section III.A. of this
preamble), studies have established that
the available COVID–19 vaccines are
highly effective at preventing
hospitalization, and even more effective
at preventing death. For example, one
study found that unvaccinated adults
age 18 to 49 were 15.2 times more likely
to be hospitalized and 17.2 times more
likely to die of COVID–19 than fully
vaccinated people in the same age
range, and unvaccinated adults age 50 to
64 were 10.9 times more likely to be
hospitalized and 17.9 times more likely
to die than their fully vaccinated peers
(Scobie et al., September 17, 2021). The
New York Times reported on October 1,
2021, that of the approximately 100,000
individuals who died of COVID–19
since mid-June 2021, less than 3% had
been identified by the CDC as
vaccinated individuals (Boseman and
Leatherby, October 1, 2021).
Vaccines are also uniquely effective
when compared to non-pharmaceutical
methods for controlling exposure to
COVID–19 at the workplace. To be sure,
non-pharmaceutical controls play an
important role in employers’ efforts to
prevent exposure to the virus; as
discussed in detail earlier, OSHA has,
throughout the pandemic, advised
employers to implement various
administrative, engineering, and other
controls to reduce workplace exposure
to the virus. And, for certain work
settings in the healthcare industry
where people with COVID–19 are
reasonably expected to be present,
OSHA both encouraged vaccination and
mandated a suite of protections, many
of which involve physical controls (see
29 CFR 1910.502). Indeed, workers who
work indoors and near others are best
protected from COVID–19 when they
are fully vaccinated and their exposure
to COVID–19 is reduced (to the extent
possible) by non-pharmaceutical
controls.
Non-pharmaceutical controls,
however, focus on preventing employee
exposure to the virus, and do not
directly affect an employee’s immune
response if exposure to the virus does
occur. Additionally, non-
pharmaceutical controls often rely on
the actions of individuals and/or the
integrity of equipment to be effective;
for example, to use PPE to control
exposure, a worker must correctly don
appropriate PPE each time there is
potential exposure, must properly clean,
store, and maintain the PPE between
uses, and must replace the PPE when it
is no longer effective (see, e.g., 29 CFR
1910.132 (general PPE requirements in
general industry workplaces)).
Accordingly, OSHA standards have
always followed the principle of the
hierarchy of controls, under which
employers must control hazards by
means other than PPE whenever
feasible, and PPE is a supplementary
control. See e.g., 29 CFR 1910.134(a); 29
CFR 1910.1030(d)(2).
Physical distancing requires workers
to maintain constant awareness of their
environment in order to avoid coming
into close proximity with colleagues,
customers, or other individuals, even
though the realities of their jobs and/or
the design of the workplace may be
unaccommodating to that effort.
Requiring employees to examine
themselves for signs and symptoms
consistent with SARS–CoV–2 infection
before reporting to work is prone to
human error and entirely ineffective
when the employee is infected but
asymptomatic or pre-symptomatic.
In contrast, a worker is considered
fully vaccinated after completing
primary vaccination with a COVID–19
vaccine, or the second dose of any
combination of two doses of a COVID–
19 vaccine that is approved, authorized,
or listed as a two-dose primary
vaccination by the FDA or WHO (see the
Summary and Explanation for
paragraph (c), Section VI.C. of this
preamble). Once fully vaccinated, a
worker enjoys automatic and long-
lasting benefits; namely, a drastic
reduction in the risk of severe health
effects or death. The vaccine works by
bolstering the worker’s immune system
and does not depend on the worker’s
acumen or actions to afford its
protection. Moreover, where an
employer implements one or more non-
pharmaceutical controls at the
workplace, vaccination provides
workers with a backstop of protection
that greatly reduces their risk of serious
health effects if they are exposed to the
virus despite the presence of other
controls. Vaccination thus ensures that
workers need not rely on other factors,
be it the workplace environment, the
effectiveness of equipment, or the
actions of other individuals, to be
substantially protected from the worst
potential outcomes of a COVID–19
infection.
This ETS focuses on encouraging
vaccination because it is the most
efficient and effective method for
addressing the grave danger.
Vaccination is patently appropriate and
feasible for almost every worker in all
industries, and will drastically reduce
the risk that unvaccinated workers will
suffer the serious health outcomes
associated with SARS–CoV–2 infection.
As described in Section III.A. of this
preamble (Grave Danger), employees
who are unvaccinated are in grave
danger from the SARS–CoV–2 virus, but
employees who are fully vaccinated are
not. Since it is the lack of vaccination
that results in grave danger, vaccination
will best allay the grave danger. This
ETS, which is designed to strongly
encourage vaccination, is thus
‘‘necessary to protect employees’’ from
a grave danger. 29 U.S.C. 655(c).
OSHA continues to encourage
employers to implement additional
controls that may be appropriate to
eliminate exposure to the SARS–CoV–2
virus at their workplace, but, as
discussed further below, OSHA has not
required employers to implement a
comprehensive and multilayered set of
COVID–19 exposure controls in this
ETS. This decision reflects the
extraordinary and exigent circumstances
have required OSHA to immediately
promulgate this emergency temporary
standard. Although OSHA was able to
design a comprehensive infection
prevention program for the specific
healthcare settings to which the June
2021 Healthcare ETS applied, this rule
encompasses all industries covered by
the OSH Act, and targets unvaccinated
workers in any indoor work setting not
covered by the Healthcare ETS where
more than one person is present.
Crafting a multi-layered standard that is
comprehensive and feasible for all
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covered work settings, including mixed
settings of vaccinated and unvaccinated
workers, is an extraordinarily
challenging and complicated
undertaking, yet the grave danger that
COVID–19 poses to unvaccinated
workers obliges the agency to act as
quickly possible. As discussed above,
OSHA has identified vaccination as the
single most efficient and effective means
for removing an unvaccinated worker
from the grave danger.
Given the urgency of the rulemaking,
and the singular effectiveness of
vaccination in removing unvaccinated
workers from the grave danger, OSHA is
promulgating this ETS to immediately
address the grave danger that COVID–19
poses to unvaccinated workers by
strongly encouraging vaccination. As
discussed in Pertinent Legal Authority
(Section II. of this preamble), a ‘‘grave
danger’’ represents a risk greater than
the ‘‘significant risk’’ that OSHA must
show in order to promulgate a
permanent standard under section 6(b)
of the OSH Act, 29 U.S.C. 655(b). OSHA
will consider whether it is necessary to
require additional controls to avert a
significant risk of harm in the
rulemaking proceedings that follow this
ETS. OSHA directs employers to its
website, www.osha.gov/coronavirus,
and the CDC’s website, www.cdc.gov/
coronavirus, for guidance on the
engineering, administrative, and other
exposure controls that may be effective
and appropriate for their workplace.
OSHA expects that, by strongly
encouraging vaccination, this ETS will
have a positive impact on worker
health. As discussed above, millions of
workers remain unvaccinated and are
presently exposed to risks of
hospitalization and death many times
higher than their vaccinated coworkers.
Although predicting the health impact
of this ETS is particularly challenging,
given the ever-changing nature of the
pandemic and the many factors that
may motivate workers to become fully
vaccinated, OSHA has attempted to
quantify the potential number of
hospitalizations and fatalities that this
ETS could avert by increasing workforce
vaccination rates (see OSHA, October
2021c). OSHA has estimated that, as a
result of the ETS, over 6,500 fewer
currently unvaccinated workers will die
from COVID–19 over the next six
months. OSHA also estimates that this
ETS will prevent over 250,000 currently
unvaccinated workers from being
hospitalized during that same time
period. Even if OSHA’s estimate does
not prove to be precisely accurate,
OSHA is confident that this ETS will
save hundreds of lives and prevent
thousands of workers from becoming
severely ill.
a. OSHA Finds It Necessary To Strongly
Encourage Vaccination
Despite the proven safety and efficacy
of the available COVID–19 vaccines,
many workers remain unvaccinated and
are currently exposed to a grave danger.
As discussed in Grave Danger (Section
III.A. of this preamble), countless
COVID–19 outbreaks have occurred in
myriad work settings where employees
come into contact with others, and in
recent weeks, the majority of states in
the U.S. have experienced what CDC
defines as high or substantial
community transmission, indicating
that there is a clear risk of the virus
being introduced into and circulating in
workplaces (CDC, October 18, 2021—
Community Transmission Rates). As of
October 18, 2021, more than 184 million
people in the United States have been
fully vaccinated, but only 68.5% of
people ages 18 years or older are fully
vaccinated (CDC, October 18, 2021—
Fully Vaccinated). OSHA has estimated
that approximately 62.4% percent of
adults aged 18–74 within the scope of
this ETS are either fully vaccinated or
received their first vaccine dose during
the previous two weeks, leaving
approximately 31.7 million
unvaccinated (i.e., not fully vaccinated
and did not receive a first dose with in
the past two weeks) (see Economic
Analysis, Section IV.B. of this preamble,
Table IV.B.7). Meanwhile, the rate of
new vaccinations has slowed
considerably; on October 15, 2021, the
7-day moving average number of
administered vaccine doses reported to
the CDC per day was 841,731 doses, a
steep reduction from the peak 3,448,156
dose average that the CDC reported on
April 11, 2021 (CDC, October 18, 2021—
Weekly Review).
Given the pervasiveness of the virus
in workplaces across the country and
the unparalleled efficacy of vaccines at
preventing serious health effects, OSHA
finds it necessary to strongly encourage
vaccination. Encouraging vaccination is
principally necessary to reduce the
likelihood that workers who are infected
by the SARS–CoV–2 virus will suffer
the worst outcomes of an infection
(hospitalization and death). Put simply,
the single best method for protecting an
unvaccinated worker from the serious
health consequences of a COVID–19
infection is for that worker to become
fully vaccinated.
Additionally, encouraging vaccination
is necessary to reduce the overall
prevalence of the SARS–CoV–2 virus at
workplaces. Because vaccinated workers
are less likely than unvaccinated
workers to be infected by the virus, they
are less likely to spread the virus to
others at their workplace, including to
unvaccinated coworkers. Increasing
workforce vaccination rates will
therefore reduce the risk that
unvaccinated workers will be infected
by a coworker.
Evidence shows that mandating
vaccination has proven to be an
effective method for increasing
vaccination rates, and that vaccination
mandates have generally been more
effective than merely encouraging
vaccination. Significant numbers of
workers would get vaccinated if their
employers required it, and many
workers who were vaccinated over the
last four months were motivated by
their employer requiring vaccination.
The Kaiser Family Foundation (KFF)
vaccine monitor, an ongoing research
project tracking the public’s attitudes
and experiences with COVID–19
vaccinations, conducted a survey from
September 13 to September 22, 2021,
among a nationally representative
random digit dial telephone sample of
1,519 adults ages 18 and older, and
found that those who received their first
dose of a COVID–19 vaccine after June
1, 2021 were motivated by mandates of
various sorts, including one in five
(19%) who say a major reason was that
their employer required it (KFF,
September 2021). A survey conducted
by Change Research from August 30 to
September 2, 2021 regarding Americans’
views on COVID–19 vaccines found that
among the 1,775 respondents, ‘‘one of
the things that was most likely to lead
someone to get vaccinated was if their
employer required it’’ (Towey,
September 27, 2021).
Vaccine mandates imposed by state
governments and large employers have
also demonstrated the effectiveness of
mandates in increasing vaccination
rates. For example, when Tyson Foods
announced its vaccination requirement
in early August 2021, only 45% of its
workforce had received a vaccination
dose, but as of September 30, 2021, the
New York Times reported that has
increased to 91% (White House, October
7, 2021; Hirsch, September 30, 2021).
Similarly, United Airlines reported that
97% of its U.S.-based employees were
fully vaccinated against COVID–19
within a week of the deadline of the
company’s vaccination mandate, and
the 3% who were not fully vaccinated
included several employees who sought
a medical or religious exemption from
vaccination (The Associated Press,
September 22, 2021). In Washington
State, the weekly vaccination rate
increased 34% after the Governor
announced vaccine requirements for
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state workers (White House, October 7,
2021). The success of these COVID–19
vaccination mandates comports with the
National Safety Council’s recent finding
that employers that instituted a COVID–
19 vaccination mandate produced a
35% increase in employee vaccination
(NSC, September 2021). Similarly, the
White House recently reported that its
analysis of vaccination requirements
imposed by healthcare systems,
educational institutions, public-sector
agencies, and private businesses
demonstrated that such requirements
increased their vaccination rates by
more than 20 percentage points and
have routinely seen their share of fully
vaccinated workers rise above 90
percent (White House, October 7, 2021).
Given the effectiveness of vaccination
mandates in increasing vaccination
rates, OSHA expects that, in most
instances, an employer implementing a
policy that requires all employees to be
vaccinated will be the most effective
approach for increasing the vaccination
rate of its employees and ensuring that
they have the best protection available
against the worst consequences of a
COVID–19 infection. Although OSHA
may well have the authority to impose
a vaccination mandate, OSHA has
decided against pursuing strict
vaccination requirement and has instead
crafted the ETS to strongly encourage
vaccination. Employers are in the best
position to understand their workforces
and the approach that will work most
effectively with them to secure
employee cooperation and protection.
OSHA’s traditional practice when
including medical procedures, such as
medical surveillance testing and
vaccinations, in its health standards has
been to require the employer to make
the medical procedure available to
employees, and has viewed mandating
those procedures as a measure to avoid
if possible. For example, when the
agency promulgated its standard
regulating occupational exposure to
lead, OSHA considered mandating that
employees participate in physical
examinations and biological monitoring,
but ultimately required employers to
make them available to employees (see
43 FR 54354, 54450 (Nov. 21, 1978)).
OSHA decided against mandating those
procedures in part because it believed a
voluntary approach would elicit more
effective employee participation in the
medical program and in part because of
the agency’s concerns about the
Government intruding into a private and
sensitive area of workers’ lives (43 FR at
54450–51). OSHA has followed that
same approach of requiring employers
to ‘‘provide’’ or ‘‘make available’’
medical procedures to employees in
numerous subsequent standards, such
as the standards for asbestos (29 CFR
1910.1001), benzene (1910.1028), cotton
dust (1910.1043), and formaldehyde
(1910.1048).
OSHA adhered to this approach when
it promulgated the Bloodborne
Pathogens standard. The agency
considered mandating a Hepatitis B
vaccination, but instead required
employers to make the Hepatitis B
vaccination available to employees. 56
FR 64004, 64155 (Dec. 6, 1991); 29 CFR
1910.1030(f)(1)(i), (f)(2)(i). OSHA
explained that the agency may have the
legal authority to mandate vaccination,
but believed that, under the
circumstances, a voluntary vaccination
program would ‘‘foster greater employee
cooperation and trust in the system’’
and ‘‘enhance [ ] compliance while
respecting individuals’ beliefs and
rights to privacy.’’ 56 FR at 64155.
In keeping with this traditional
practice, the agency has stopped short of
including a strict vaccination mandate
with no alternative compliance option
in this ETS. OSHA has never done so,
and if it were to take that step, OSHA
believes it more prudent to do so where
the agency has ample time to fully
assess the potential ramifications of
imposing a vaccination mandate on
covered employers and employees.
Here, exigent circumstances demand
that OSHA take immediate action to
protect workers from the grave danger
posed by COVID–19, but OSHA has not
had a full opportunity to study the
potential spectrum of impacts on
employers and employees, including the
economic and health impacts, that
would occur if OSHA imposed a strict
vaccination mandate with no alternative
compliance option. Moreover,
employers in their unique workplace
settings may be best situated to
understand their workforce and the
strategies that will maximize worker
protection while minimizing workplace
disruptions. These considerations
persuade the agency that this ETS
should afford employers some flexibility
in the form of an alternative option to
strictly mandating vaccination. In light
of the unique and grave danger posed by
COVID–19, OSHA has requested
comment on whether a strict
vaccination mandate is warranted and
the agency will consider all the
information it receives as it determines
how to proceed with this rulemaking
(see Request for Comment, Section I.B.
of this preamble).
Although this ETS does not impose a
strict vaccination mandate, OSHA has
determined that, to adequately address
the grave danger that COVID–19 poses
to unvaccinated workers, a more
proactive approach is necessary than
simply requiring employers to make
vaccination available to employees.
None of the standards that OSHA
promulgated prior to this year
concerned an infectious agent as readily
transmissible as COVID–19. Standards
like the Lead standard do not concern
infectious agents that can be transmitted
between individuals at a workplace;
accordingly, the medical procedures
that employers are required to make
available under those standards are
solely aimed at protecting the health of
the worker who is undergoing the
procedure. The Bloodborne Pathogens
standard concerned exposure to
infectious biological agents (Hepatitis B
and HIV) that can be transmitted
between individuals, but the potential
for those agents to be transmitted
between workers is minimal in
comparison to the SARS–CoV–2 virus;
Hepatitis B and HIV are transmitted
through blood and certain body fluids,
whereas the SARS–CoV–2 virus spreads
through respiratory droplets that can
travel through the air from worker-to-
worker (see Grave Danger, Section III.A.
of this preamble). Vaccination against
COVID–19 is thus particularly
important in reducing the potential for
workers to become infected and spread
the virus to others at the workplace, in
addition to protecting the worker from
severe health outcomes if they are
infected. Moreover, the ease with which
the SARS–CoV–2 virus spreads between
workers makes it more urgent for
workers to be vaccinated, and this
urgency contributes to the agency’s
decision to strongly encourage
vaccination.
Accordingly, to further the goal of
increasing workforce vaccination rates,
this ETS requires employers to
implement a mandatory vaccination
policy unless they adopt a policy in
which employees may either be fully
vaccinated or regularly tested for
COVID–19 and wear a face covering in
most situations when they work near
other individuals. Employers have the
duty under the OSH Act to provide safe
workplaces to their employees,
including protecting employees from
known hazards by complying with
occupational safety and health
standards (see 29 U.S.C. 654), and this
ETS therefore provides employers with
two compliance options for protecting
unvaccinated workers from the grave
danger posed by COVID–19. But while
this ETS offers employers a choice in
how to comply, OSHA has presented
implementation of a vaccination
mandate as the preferred compliance
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option; as discussed above, vaccine
mandates have proven to be effective in
increasing vaccination rates, and OSHA
expects that, in most instances,
implementing a vaccination mandate
will be the most effective method for
increasing a workforce’s vaccination
rate. As discussed below, OSHA also
recognizes that requiring that all
employees be vaccinated provides more
protection to vaccinated workers than
regularly testing unvaccinated workers
for COVID–19 and requiring them to
wear face coverings when they work
near others. This ETS will preempt
inconsistent state and local
requirements, including requirements
that ban or limit employers’ authority to
require vaccination (see the Summary
and Explanation for paragraph (a),
Section VI.A. of this preamble), and will
therefore provide the necessary legal
authorization to covered employers to
implement mandatory vaccination
policies, if they choose to comply in this
preferred manner.
Although the ETS does not require all
covered employers to implement a
mandatory vaccination policy, OSHA
expects that employers that choose that
compliance option will enjoy
advantages that employers that opt out
of the vaccination mandate option will
not. Most obviously, employers with a
mandatory vaccination policy will enjoy
a dramatically reduced risk that their
employees will become severely ill or
die of a COVID–19 infection. In
addition, employers who implement a
vaccination mandate will likely have
fewer workers temporarily removed
from the workplace due to a COVID–19
positive test; this rule requires all
covered employers to remove from the
workplace any employee who tests
positive for COVID–19 or receives a
diagnosis of COVID–19 (see the
Summary and Explanation for
paragraph (h), Section VI.H. of this
preamble), and because vaccinated
workers are less likely than
unvaccinated workers to be infected by
the virus, OSHA expects employers
with a mandatory vaccination policy
will be statistically less likely to be
obliged to remove a COVID-positive
employee from the workplace in
accordance with paragraph (h)(2).
Additionally, only employers who
decline to implement a mandatory
vaccination program are required by the
rule to assume the administrative
burden necessary to ensure that
unvaccinated workers are regularly
tested for COVID–19 and wear face
coverings when they work near others.
Where employers opt out of
implementing a mandatory vaccination
program, the ETS encourages employees
to elect to be fully vaccinated. As
discussed in the Summary and
Explanation for paragraph (f) (Section
VI.F. of this preamble), the ETS requires
all covered employers to support
vaccination by providing employees
with reasonable time, including up to
four hours of paid time, to receive each
vaccination dose, and reasonable time
and paid sick leave to recover from
vaccination side effects. Many workers
have been deterred from receiving
vaccination by fears of missing work
and/or losing pay to obtain vaccination
and/or recover from side effects (see
Section VI.F. of this preamble; see, e.g.,
KFF, May 6, 2021; KFF, May 17, 2021),
and OSHA finds that this employer
support is necessary to ensure that
employees can become fully vaccinated
without concern that they will be
sacrificing pay or their jobs to do so.
All covered employers are required by
the ETS to bear the cost of providing up
to four hours of paid time and
reasonable paid sick leave needed to
support vaccination, but where an
employee chooses to remain
unvaccinated, the ETS does not require
employers to pay for the costs
associated with regular COVID–19
testing or the use of face coverings (see
the Summary and Explanation for
paragraphs (g) and (i), Sections VI.G.
and VI.I. of this preamble). In some
cases, employers may be required to pay
testing and/or face covering costs under
other federal or state laws or collective
bargaining obligations, and some may
choose to do so even without such a
mandate, but otherwise employees will
be required to bear the costs if they
choose to be regularly tested and wear
a face covering in lieu of vaccination.
This ETS more strongly encourages
vaccination than the June 2021
Healthcare ETS. OSHA designed the
Healthcare ETS, which addresses the
grave danger that COVID–19 poses
workers in specific health care settings
where COVID–19-positive individuals
are reasonably likely to be present, to
encourage vaccination (see 86 FR at
32415, 32423, 32565, 32597).
Specifically, the Healthcare ETS
encourages vaccination by requiring
employers to provide employees
reasonable and paid time to receive
vaccination doses and recover from side
effects (29 CFR 1910.502(m)), and by
exempting from its scope ‘‘well-defined
hospital ambulatory care settings where
all employees are fully vaccinated’’ and
all non-employees are screened and
denied entry if they are suspected or
confirmed to have COVID–19
(1910.502(a)(2)(iv)) and ‘‘home
healthcare settings where all employees
are fully vaccinated’’ and all
nonemployees at that location are
screened prior to employee entry so that
people with suspected or confirmed
COVID–19 are not present (1910.502
(a)(2)(v)).
Similar to the Healthcare ETS, this
ETS requires employers to support
vaccination by providing employees
with reasonable time, including up to
four hours of paid time, to receive
vaccination, and reasonable time and
paid sick leave to recover from
vaccination side effects (see discussion
above and the Summary and
Explanation for paragraph (f), Section
VI.F. of this preamble). However, as
discussed above, this ETS goes further
and expressly requires the
implementation of a mandatory
vaccination policy, unless the employer
implements an alternative policy that
requires unvaccinated workers to be
regularly tested for COVID–19 and to
wear face coverings in most situations
when they work near others. While
nothing in the Healthcare ETS prohibits
covered employers from implementing a
mandatory vaccination policy, this ETS
presents the implementation of a
mandatory vaccination policy as a
preferred compliance option, and will
preempt inconsistent state and local
requirements that ban or limit
employers’ authority to require
vaccination. Additionally, where the
employer opts out of implementing a
mandatory vaccination policy, and the
employee opts out of vaccination, this
ETS places no obligation on the
employer to pay for costs associated
with the regular testing of unvaccinated
workers for COVID–19 or their use of
face coverings, which will provide a
financial incentive for some employees
to be fully vaccinated.
OSHA finds it necessary to more
strongly encourage vaccination in this
ETS than in the Healthcare ETS in the
manner described above. The
Healthcare ETS’s provisions that
encouraged vaccination were packaged
with a comprehensive infection
prevention program that was tailored to
the specific healthcare work settings to
which the ETS applied, including a
suite of layered and overlapping
controls. In contrast, OSHA is
promulgating this ETS to address the
grave danger that COVID–19 now poses
to all unvaccinated workers who work
indoors and in the presence of others.
As mentioned above, crafting a
comprehensive and multi-layered
standard that is comprehensive and
feasible for the myriad work settings to
which this ETS will apply, including
workplaces as diverse as schools,
restaurants, retail settings, offices,
prisons, and factories, is an
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extraordinarily challenging and
complicated undertaking.
Exigent circumstances require OSHA
to immediately promulgate this ETS to
protect unvaccinated workers, and
vaccination is the single most efficient
and effective method for removing
unvaccinated workers from the grave
danger. Given the urgency of the
rulemaking and the singular efficacy of
vaccination, OSHA has decided against
including comprehensive and
multilayered exposure controls in this
ETS, and is instead focusing the ETS on
strongly encouraging vaccination.
Strongly encouraging vaccination is
thus critical to the effectiveness of this
ETS at protecting unvaccinated workers
from the grave danger. In Request for
Comment (Section I.B. of this preamble),
OSHA seeks information on what
additional measures, if any, should be
required to protect employees against
COVID–19.
Moreover, stronger encouragement of
vaccination is needed in this ETS than
in the Healthcare ETS because workers
who are protected by the Healthcare
ETS are more likely to be vaccinated
and/or subject to a vaccination mandate.
The Healthcare ETS, 29 CFR 1910.502,
focused on healthcare work settings
where COVID–19 is reasonably expected
to be present, and, this ETS does not
apply in settings where any employee
provides healthcare services or
healthcare support services while they
are covered by the requirements of 29
CFR 1910.502 (see the Summary and
Explanation for paragraph (b), Section
VI.B. of this preamble). Evidence shows
that workers in settings covered by
§ 1910.502 already have a high rate of
vaccination. As of July 2021, healthcare
workers had a higher rate of vaccination
than non-healthcare workers (Lazer et
al., August, 2021), and many healthcare
workers are currently subject to
vaccination mandates. Twenty-two
states and the District of Columbia have
instituted vaccination mandates that are
applicable to healthcare workers
(NASHP, October 1, 2021), and nearly
300 hospitals and broader health
systems have implemented vaccine
mandates for their employees (Renton et
al., October 14, 2021). The White House
reported that almost 2,500 hospitals,
40% of all U.S. hospitals, across all 50
states, the District of Columbia, and
Puerto Rico, have announced
vaccination requirements for their
workforce, and noted numerous
examples of highly successful mandates
in those workplaces (White House,
October 7, 2021). News reports attest
that many of these vaccination
mandates have had great success in
increasing the vaccination rate of the
targeted healthcare workers (Goldberg,
July 9, 2021; Otterman and Goldstein,
September 28, 2021; Hubler, September
30, 2021; Beer, October 4, 2021). Even
more healthcare workers covered by 29
CFR 1910.502 will be subject to a
vaccination mandate under the Centers
for Medicare & Medicaid Services (CMS)
rule published elsewhere in this issue of
the Federal Register that requires
COVID–19 vaccinations for workers in
most healthcare settings that receive
Medicare or Medicaid reimbursement,
including but not limited to hospitals,
dialysis facilities, ambulatory surgical
settings, and home health agencies. This
CMS rule applies to at least 76,000
providers (i.e., employers) and covers a
majority of healthcare workers across
the country. OSHA expects that the
combination of incentives to
vaccination in the Healthcare ETS and
vaccination mandates applicable to
healthcare workers will leave few
healthcare workers within the scope of
the Healthcare ETS unvaccinated.
b. Unvaccinated Workers Must Be
Regularly Tested for COVID–19 and Use
Face Coverings
As discussed above, this ETS
presumptively requires employers to
implement a mandatory vaccination
policy, but permits employers to opt out
of that requirement. Nonetheless, the
grave danger that COVID–19 poses to
unvaccinated workers demands that
alternative protective measures be taken
at workplaces where the employer does
not implement a mandatory vaccination
policy. Given that the SARS–CoV–2
virus is highly contagious, transmitted
easily through the air, and can lead to
severe and/or fatal outcomes in
unvaccinated workers, it is critical that
employers who do not require their
employees to be vaccinated implement
controls to mitigate the potential for
COVID–19 outbreaks to occur. As
discussed above, and in Grave Danger
(Section III.A. of this preamble),
unvaccinated workers are more likely
than vaccinated workers to be infected
with COVID–19 and transmit the virus
to others, and thus pose a heightened
risk of spreading the virus at the
workplace, including to other
unvaccinated workers.
To reduce the risk that unvaccinated
workers will spread COVID–19 at the
workplace, this rule requires employers
that do not implement a mandatory
vaccination policy to ensure that
unvaccinated workers who report to a
workplace where others are present are
tested at least once a week for COVID–
19. As discussed in the Summary and
Explanation for paragraph (g) (Section
VI.G. of this preamble), it is well-
established that, by identifying and
isolating infected individuals, regularly
testing individuals for COVID–19
infection can be an effective method for
reducing virus transmission. Regularly
testing unvaccinated workers is
essential because SARS–CoV–2
infection is often attributable to
asymptomatic or presymptomatic
transmission (Bender et al., February 18,
2021; Byambasuren et al., December 11,
2020; Johansson et al., January 7, 2021;
Klompas et al., September 2021). In
accordance with the CDC’s
recommendations, OSHA has set the
minimum frequency of testing at 7 days
because the agency expects that it will
be effective in slowing the spread of
COVID–19, while taking into account
associated cost considerations (see the
Summary and Explanation for
paragraph (g), Section VI.G. of this
preamble). As noted in the Request for
Comment (Section I.B. of this preamble),
OSHA is gathering additional
information about whether OSHA
should require testing more often than
on a weekly basis.
The requirement for unvaccinated
workers to be regularly tested for
COVID–19 operates in tandem with
paragraph (h)(2), which requires that all
employers remove from the workplace
any employee who receives a positive
COVID–19 test, or a COVID–19
diagnosis (see the Summary and
Explanation for paragraph (h), Section
VI.H. of this preamble). Paragraph (h)(2)
ensures that the COVID–19-positive
employee will be isolated from the
workplace until it is safe for the
employee to return, and also allows the
employee to seek medical care sooner
and reduce the likelihood that they will
suffer the most severe consequences of
an infection (e.g., by seeking
monoclonal antibody treatment). The
combination of the testing and medical
removal provisions will reduce the
likelihood that an unvaccinated worker
who has been infected with COVID–19,
including those who are not
experiencing symptoms of infection,
will be permitted to spread the virus to
others at the workplace, including
unvaccinated coworkers.
Additionally, OSHA finds it necessary
to require employers that do not
implement a mandatory vaccination
policy to ensure that unvaccinated
workers wear face coverings in most
situations when they are working near
others. This reflects OSHA’s recognition
that regularly testing unvaccinated
workers for COVID–19 will not be 100%
effective in identifying infected workers
before they enter the workplace. Most
obviously, testing employees once a
week will not prevent an unvaccinated
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worker from exposing others at the
workplace if the worker becomes
infected and reports to the workplace in
between their weekly tests. And, even if
the rule required unvaccinated workers
to be tested more frequently than once
a week, infected persons may still be
missed, particularly in areas with high
community spread (Chin et al.,
September 9, 2020).
Accordingly, requiring unvaccinated
workers to wear face coverings in most
situations when they are working near
others will further mitigate the potential
for unvaccinated workers to spread the
virus at the workplace. As discussed in
the Summary and Explanation for
paragraph (i) (Section VI.I. of this
preamble), it is well-established that
face coverings provide effective source
control; that is, they largely prevent
respiratory droplets emitted by the
wearer of the face covering from
spreading to others, and thus make it
significantly less likely that the person
wearing the mask will transmit the
virus, if they are infected. Face
coverings are also believed to provide
the wearer some limited protection from
exposure to the respiratory droplets of
co-workers and others (e.g., customers)
(CDC, May 7, 2021), but the principal
benefit of face coverings is to
significantly reduce the wearer’s ability
to spread the virus. By requiring
unvaccinated workers to wear face
coverings, this rule significantly reduces
the likelihood that an infected
unvaccinated worker who enters the
workplace despite the testing
requirements will spread the virus to
others, including unvaccinated
coworkers.
OSHA acknowledges that regularly
testing unvaccinated workers for
COVID–19 and requiring them to wear
face coverings when they work near
others is less protective of unvaccinated
workers than simply requiring all
workers to be vaccinated. To be sure,
OSHA strongly prefers that employers
adopt a mandatory vaccination policy,
as vaccination is singularly effective at
protecting workers from the severe
consequences that can result from a
COVID–19 infection. And, where
employers do not adopt a mandatory
vaccination policy, employers may also
consider alternative feasible measures
that would remove employees who
remain unvaccinated from the scope of
this ETS, such as increasing telework
(see the Summary and Explanation for
paragraph (b), Section VI.B. of this
preamble). Nonetheless, as discussed
above, OSHA has not imposed a strict
vaccination mandate on all covered
employees who work in the presence of
others and not exclusively outdoors,
given that the agency has never
previously used its authority to strictly
mandate vaccination, and the exigent
and extraordinary circumstances driving
this emergency rulemaking have not
afforded OSHA a full opportunity to
assess the potential ramifications of
including a strict vaccination mandate
in this rule. Given these circumstances,
and employers’ unique understanding of
the compliance approaches that will
best increase vaccination rates among
their workforce, OSHA has designed a
rule that preserves a limited degree of
employer flexibility, and strongly
encourages, but does not strictly require,
vaccination. OSHA has requested
comment in this ETS on whether a strict
vaccination mandate would be
appropriate and the agency will
consider those comments as it
determines how to proceed with this
rulemaking.
References
Beer T. (2021, October 4). COVID–19 Vaccine
Mandates Are Working—Here’s The
Proof. Forbes. https://www.forbes.com/
sites/tommybeer/2021/10/04/covid-19-
vaccine-mandates-are-working-heres-
the-proof/?sh=1a08d2e72305. (Beer,
October 4, 2021)
Bender JK et al. (2021, February 18). Analysis
of asymptomatic and presymptomatic
transmission in SARS–CoV–2 outbreak,
Germany, 2020. Emerging Infectious
Diseases. 27(4). https://doi.org/10.3201/
eid2704.204576. (Bender et al., February
18, 2021)
Boseman J and Leatherby L. (2021, October
1). U.S. Coronavirus Death Toll
Surpasses 700,000 Despite Wide
Availability of Vaccines. The New York
Times. https://www.nytimes.com/2021/
10/01/us/us-covid-deaths-700k.html.
(Boseman and Leatherby, October 1,
2021)
Byambasuren O et al., (2020, December 11).
Estimating the extent of asymptomatic
COVID–19 and its potential for
community transmission: Systematic
review and meta-analysis. Official
Journal of the Association of Medical
Microbiology and Infectious Disease
Canada. 5(4): 223–234 doi:10.3138/
jammi-2020-0030. (Byambasuren et al.,
December 11, 2020)
Centers for Disease Control and Prevention
(CDC). (2021, May 7). Science brief:
Community use of cloth masks to control
the spread of SARS–CoV–2. https://
www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/masking-science-
SARS-cov2.html. (CDC, May 7, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, October 18). COVID Data
Tracker. https://covid.cdc.gov/covid-
data-tracker/. (CDC, October 18, 2021)
Chin E et al. (2020, September 9). Frequency
of routine testing for COVID–19 in high-
risk healthcare environments to reduce
outbreaks. https://doi.org/10.1101/
2020.04.30.20087015. (Chin et al.,
September 9, 2020)
Food and Drug Administration (FDA). (2020,
December 11). Emergency use
authorization for an unapproved product
review memorandum (Pfizer-BioNTech
COVID–19 vaccine/BNT 162b2 mRNA–
1273). https://www.fda.gov/emergency-
preparedness-and-response/coronavirus-
disease-2019-covid-19/pfizer-biontech-
covid-19-vaccine. (FDA, December 11,
2020)
Food and Drug Administration (FDA). (2020,
December 18). Emergency use
authorization for an unapproved product
review memorandum (Moderna COVID–
19 vaccine/mRNA–1273). https://
www.fda.gov/emergency-preparedness-
and-response/coronavirus-disease-2019-
covid-19/moderna-covid-19-vaccine.
(FDA, December 18, 2020)
Food and Drug Administration (FDA). (2021,
February 26). Janssen COVID–19
vaccine. Vaccines and Related Biological
Products Advisory Committee February
26, 2021 Meeting Briefing Document.
https://www.fda.gov/media/146219/
download. (FDA, February 26, 2021)
Goldberg C. (2021, July 9). Hospital Vaccine
Mandates Suggest Success in Boosting
U.S. Shots. Bloomberg News. https://
www.bloomberg.com/news/articles/2021-
07-09/early-mandates-boost-worker-
vaccine-rates-prompt-few-to-quit.
(Goldberg, July 9, 2021)
Hirsch L. (2021, September 30). After
Mandate, 91% of Tyson Workers Are
Vaccinated. https://www.nytimes.com/
2021/09/30/business/tyson-foods-
vaccination-mandate-rate.html. (Hirsch,
September 30, 2021)
Hubler S. (2021, September 30). ‘Mandates
Are Working’: Employer Ultimatums Life
Vaccination Rates, So Far. The New York
Times. https://www.nytimes.com/2021/
09/30/us/california-vaccine-mandate-
health-care.html. (Hubler, September 30,
2021)
Johansson MA et al., (2021, January 7).
SARS–CoV–2 transmission from people
without COVID–19 symptoms. JAMA
Network Open. 4(1): e2035057.
doi:10.1001/jamanetworkopen.
2020.35057. (Johansson et al., January 7,
2021)
Kaiser Family Foundation (KFF). (2021, May
6). KFF COVID–19 Vaccine Monitor:
April 2021. https://www.kff.org/
coronavirus-covid-19/poll-finding/kff-
covid-19-vaccine-monitor-april-2021/.
(KFF, May 6, 2021)
Kaiser Family Foundation (KFF). (2021, May
17). How employer actions could
facilitate equity in COVID–19
vaccinations. https://www.kff.org/policy-
watch/how-employer-actions-could-
facilitate-equity-in-covid-19-
vaccinations/. (KFF, May 17, 2021)
Kaiser Family Foundation (KFF). (2021,
September). Does The Public Want To
Get A COVID–19 Vaccine? When?
https://www.kff.org/coronavirus-covid-
19/dashboard/kff-covid-19-vaccine-
monitor-dashboard/?utm_
source=web&utm_
medium=trending&utm_
campaign=COVID-19-vaccine-
monitor#messagesandinformation. (KFF,
September 2021)
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18 This adoption includes the citations in the
referenced section of the Healthcare ETS, which are
also included in the docket for this ETS.
Klompas M et al. (2021, September). The case
for mandating COVID–19 vaccines for
health care workers. Annals of Internal
Medicine. https://doi.org/10.7326/M21-
2366. (Klompas et al., September 2021)
Lazer D et al. (2021, August). The COVID
States Project: A 50-State COVID–19
Survey Report #62: COVID–19 Vaccine
Attitudes Among Healthcare Workers.
http://news.northeastern.edu/uploads/
COVID19%20CONSORTIUM%20
REPORT%2062%20HCW%20
August%202021.pdf. (Lazer et al.,
August, 2021)
National Academy for State Health Policy
(NASHP). (2021, October 1). State Efforts
to Ban or Enforce COVID–19 Vaccine
Mandates and Passports. https://
www.nashp.org/state-lawmakers-submit-
bills-to-ban-employer-vaccine-mandates/
. (NASHP, October 1, 2021)
National Safety Council (NSC). (2021,
September). A Year in Review, and
What’s Next: COVID–19 Employer
Approaches and Worker Experiences.
https://www.nsc.org/faforms/safer-year-
one-final-report. (NSC, September 2021)
Occupational Safety and Health
Administration (OSHA). (2021c,
October). Health Impacts of the COVID–
19 Vaccination and Testing ETS. (OSHA,
October 2021c)
Otterman S and Goldstein J. (2021,
September 28). Thousands of N.Y.
Health Care Workers Get Vaccinated
Ahead of Deadline. The New York
Times. https://www.nytimes.com/2021/
09/28/nyregion/vaccine-health-care-
workers-mandate.html. (Otterman and
Goldstein, September 28, 2021)
Renton B et al. (2021, October 14). New:
Hospital Vaccine Mandate Tracker.
Global Epidemics, Brown School of
Public Health. https://
globalepidemics.org/2021/07/24/new-
hospital-vaccine-mandate-tracker/.
(Renton et al., October 14, 2021)
Scobie HM et al. (2021, September 17).
Monitoring Incidence of COVID–19
Cases, Hospitalizations, and Deaths, by
Vaccination Status—13 U.S.
Jurisdictions, April 4–July 17, 2021.
MMWR Morb Mortal Wkly Rep 2021; 70:
early release. https://www.cdc.gov/
mmwr/volumes/70/wr/mm7037e1.htm.
(Scobie et al., September 17, 2021)
The Associated Press. (2021, September 22).
United Airlines says 97% of US
employees have been vaccinated. https://
www.wifr.com/2021/09/22/united-
airlines-say-97-us-employees-have-been-
vaccinated/. (The Associated Press,
September 22, 2021)
Towey R. (2021, September 27). CNBC poll
shows very little will persuade
unvaccinated Americans to get Covid
shots. https://www.cnbc.com/2021/09/
10/cnbc-poll-shows-very-little-will-
persuade-unvaccinated-americans-to-
get-covid-shots.html. (Towey, September
27, 2021)
White House. (2021, October 7). White House
Report: Vaccination Requirements Are
Helping Vaccinate More People, Protect
Americans from COVID–19, and
Strengthen the Economy. https://
www.whitehouse.gov/wp-content/
uploads/2021/10/Vaccination-
Requirements-Report.pdf. (White House,
October 7, 2021)
III. No Other Agency Action is Adequate
To Protect Employees Against Grave
Danger
OSHA’s experience to date shows that
the agency’s existing tools are
inadequate to meet the grave danger
posed by COVID–19 to unvaccinated
workers not covered by the Healthcare
ETS. OSHA has determined that its
existing standards, regulations, the OSH
Act’s General Duty Clause, and non-
mandatory guidance will not adequately
promote the most effective means to
protect these workers: Vaccination. The
agency has determined that this ETS is
necessary to address these inadequacies.
Multiple developments support this
change in approach. First, large
numbers of employees are continuing to
contract COVID–19 and die. (See Grave
Danger, Section III.A. of this preamble).
Further, based on a thorough review of
its existing approach to protecting
employees from COVID–19 and the
current state of the pandemic, OSHA
finds that existing OSHA standards,
regulations, the General Duty Clause,
and non-mandatory guidance are not
adequate to protect employees outside
healthcare from COVID–19. The
Preamble to the Healthcare ETS
includes a detailed analysis
demonstrating the inadequacy of
existing tools in the healthcare industry.
See 86 FR 32414–32423. In general, the
same analysis applies here. The reasons
existing tools were inadequate to protect
healthcare workers apply in other
industry sectors as well. The Healthcare
ETS itself, while necessary to protect
healthcare workers, of course applies
only to that industry. Finally, the
numerous guidance products published
by other entities, such as CDC, are not
adequate to protect employees because
they are not enforceable; there is no
penalty for noncompliance. 86 FR at
32415. Even as the CDC has increasingly
recommended vaccination to protect
from the dangers of transmission and
severe illness related to the SARS–CoV–
2 virus, vaccination rates remain uneven
around the country. (CDC, September 9,
2021; Leonhardt, September 7, 2021;
KFF, October 6, 2021; McPhillips and
Cohen, May 19, 2021).
The need for this ETS is also reflected
in the number of states and localities
that have issued their own mandatory
standards in recognition that OSHA’s
existing measures (including non-
mandatory guidance, compliance
assistance, and enforcement of existing
standards) have failed to prevent the
spread of the virus in workplaces.
Additionally, as mentioned previously,
other states have banned certain
employers from implementing
workplace vaccination mandates or
from verifying an employee’s
vaccination status or from requiring face
coverings. A national standard is
necessary to establish clear
requirements regarding vaccination,
testing and face coverings that will
protect employees in all states and
preempt state or local ordinances that
prevent employers from implementing
necessary protections.
a. The Current Standards and
Regulations Are Inadequate
In the Healthcare ETS, OSHA
considered its enforcement efforts with
regard to existing standards and
regulations that OSHA had identified as
potentially applicable to occupational
exposure to SARS–CoV–2. OSHA’s
analysis in Section IV of the Healthcare
ETS, 86 FR 32376, 32416–17 and hereby
included in the record of this ETS,18 is
applicable here in considering the need
for this ETS, which covers a much
broader set of employers in all
industries. There OSHA found that none
of the existing OSHA standards could
sufficiently abate the hazard posed by
COVID–19 in healthcare settings. Here
again OSHA concludes that the
potentially applicable existing standards
are insufficient to address the grave
danger faced by workers covered by this
ETS. None of the current standards,
even if more rigorously enforced, can
sufficiently address this cross-industry
hazard of national proportions to abate
the grave danger posed by COVID–19 or
lead to the same benefits that this ETS
will achieve. See Asbestos Info. Ass’n/
N. Am. v. Occupational Safety & Health
Admin., 727 F.2d 415, 427 (5th Cir.
1984) (‘‘[M]uch of the claimed benefit
could be obtained simply by enforcing
the current standard.’’).
Through its enforcement guidance,
OSHA identified a number of current
standards and regulations that might
apply when workers have occupational
exposure to SARS–CoV–2, most of
which are the same standards OSHA
considered in the Healthcare ETS.
(Updated Interim Enforcement Response
Plan for Coronavirus Disease 2019
(COVID–19)) (OSHA, July 7, 2021).
OSHA has also cited the Hazard
communication standard (29 CFR
1910.1200) during COVID–19
investigations. Accordingly, a list of
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potentially applicable standards and
regulations follows:
• 29 CFR part 1904, Recording and
Reporting Occupational Injuries and
Illnesses. This regulation requires
certain employers to keep records of
work-related fatalities, injuries, and
illnesses and report them to the
government in specific circumstances.
• 29 CFR 1910.132, General
requirements—Personal Protective
Equipment (PPE). This standard
requires that appropriate PPE, including
PPE for eyes, face, head, and
extremities, protective clothing,
respiratory devices, and protective
shields and barriers, be provided, used,
and maintained in a sanitary and
reliable condition.
• 29 CFR 1910.134, Respiratory
protection. This standard requires that
employers provide, and ensure the use
of, appropriate respiratory protection
when necessary to protect employee
health.
• 29 CFR 1910.141, Sanitation. This
standard applies to permanent places of
employment and contains, among other
requirements, general housekeeping and
waste disposal requirements.
• 29 CFR 1910.145, Specification for
accident prevention signs and tags. This
standard requires the use of biological
hazard signs and tags, in addition to
other types of accident prevention signs
and tags.
• 29 CFR Subpart U—COVID–19
Emergency Temporary Standard. The
Healthcare ETS, promulgated on June
21, 2021 includes various controls
(patient screening and management,
respirators and other PPE, limiting
exposure to aerosol-generating
procedures, physical distancing,
physical barriers, cleaning, disinfection,
ventilation, health screening and
medical management, access to
vaccination, anti-retaliation provisions,
and medical removal protection) to
address the grave danger posed by
COVID–19 to healthcare workers.
• 29 CFR 1910.1020, Access to
employee exposure and medical
records. This standard requires that
employers provide employees and their
designated representatives access to
relevant exposure and medical records.
• 29 CFR 1910.1200, Hazard
communication. This standard requires
employers to keep Safety Data Sheets
(SDS) for chemical hazards, provide
SDSs to employees and their
representatives when requested, and
train employees about those hazards.
The standard does not apply to
biological hazards, but hazard
communication becomes an issue for
the SARS–CoV–2 virus when chemicals
are used to disinfect surfaces.
OSHA again finds that none of these
existing standards provide for the types
of workplace controls that are necessary
to combat the grave danger addressed by
this ETS. First, none of the listed
potentially applicable standards require
vaccination against SARS–CoV–2, the
most efficient and effective control to
combat the grave danger posed by the
virus. (The Bloodborne Pathogen
Standard requires that the hepatitis B
vaccine be made available to certain
employees, but that is not that is not
relevant here, since the hepatitis
vaccine provides no protection against
COVID–19). Nor are the additional
safety measures included in this ETS—
vaccination verification, screening
testing, face coverings, and medical
removal of COVID–19 positive
workers— required by existing
standards other than OSHA’s Healthcare
ETS (covering employees exempted
from this new ETS while the Healthcare
ETS is in effect).
Second, because existing standards do
not contain provisions specifically
targeted at the COVID–19 hazard, it may
be difficult for employers and
employees to determine what particular
COVID–19 safety measures are required
by existing standards, or how the
separate standards are expected to work
together as applied to COVID–19. An
ETS that contains provisions
specifically addressing COVID–19
hazards in covered workplaces will
provide clear instructions. More
certainty will lead to more compliance,
and more compliance will lead to
improved protection of employees
covered by this standard.
Third, requirements in some
standards may be appropriate for other
situations but simply do not
contemplate COVID–19 and fail to
address important aspects of the hazard.
For example, the general sanitation
standard requires employers to provide
warm water, soap, and towels that can
be used in hand washing, but does not
require disinfection or provision of
hand sanitizer where handwashing
facilities cannot be made readily
available. See 86 FR 32417. Although
the sanitation standard might appear at
first glance to be relevant here, it simply
does not require the types of controls
that would, even if more rigorously
enforced, sufficiently reduce the threat
of COVID–19 in the workplace. As such,
OSHA affirms its previous
determination that some of the above-
listed standards—including the
sanitation standard—are in practice too
difficult to apply to the COVID–19
hazard and have never been cited in
COVID enforcement. 86 FR 32416.
Fourth, existing recordkeeping and
reporting regulations do not adequately
allow the employer or the agency to
assess the full scope of COVID–19
workplace exposures and protection.
OSHA’s general recordkeeping
regulations were not written with the
nature of COVID–19 transmission or
illness in mind. In order to adequately
understand and thereby control the
spread of COVID–19 in the workforce, it
is critical that the employer has records
of employees’ vaccination status, and of
the testing undergone by employees
who do not receive vaccination, and
that it knows of all cases of COVID–19
occurring among employees. However,
such information is outside of the scope
of OSHA’s existing recordkeeping
requirements, which are limited to
injuries or illnesses that the employer
knows to be work-related.
Moreover, existing reporting
regulations do not adequately ensure
that OSHA has the full picture of the
impact of COVID–19 because those
regulations only require employers to
report in-patient hospitalizations that
occur within 24 hours of the work-
related incident and to report fatalities
that occur within thirty days of the
work-related incident. 86 FR at 32417.
Many COVID–19 infections will not
result in hospitalization or death until
well after these limited reporting
periods. Under existing regulations,
such cases are not required to be
reported to OSHA, which limits the
agency’s ability to fully understand the
impact of COVID–19 on the workforce.
86 FR 32417. This ETS includes a
provision, paragraph (k), that removes
the time limitation on reporting for
COVID–19 cases.
In conclusion, OSHA’s experience has
demonstrated that existing standards
and regulations are inadequate to
address the current COVID–19 hazard.
b. The General Duty Clause Is
Inadequate To Meet the Current Crisis
Section 5(a)(1) of the OSH Act, or the
General Duty Clause, provides the
general mandate that each employer
‘‘furnish to each of [its] employees
employment and a place of employment
which are free from recognized hazards
that are causing or are likely to cause
death or serious physical harm to [its]
employees.’’ 29 U.S.C. 654(a)(1). For
General Duty Clause citations to be
upheld, OSHA must demonstrate
elements of proof that are
supplementary to, and can be more
difficult to show than, the elements of
proof required for violations of specific
standards, where a hazard is presumed.
Specifically, to prove a violation of the
General Duty Clause, OSHA needs to
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establish—in each individual case—
that: (1) An activity or condition in the
employer’s workplace presented a
hazard to an employee; (2) the hazard
was recognized; (3) the hazard was
causing or was likely to cause death or
serious physical harm; and (4) feasible
means to eliminate or materially reduce
the hazard existed. BHC Nw. Psychiatric
Hosp., LLC v. Sec’y of Labor, 951 F.3d
558, 563 (D.C. Cir. 2020). OSHA often
relies on the General Duty Clause to fill
gaps where specific standards do not
address a hazard and OSHA enforces it
through case-by-case adjudicative
proceedings. See United States v.
Strum, 84 F.3d 1, 5 (1st Cir. 1996).
OSHA has previously found the
General Duty Clause to be inadequate to
protect employees from dangers posed
by infectious agents. In promulgating
the bloodborne pathogens standard,
OSHA explained that enforcement
under the General Duty Clause was
insufficient to protect employees from
the serious hazards those pathogens
present. 56 FR 64007 (December 6,
1991). In the recently promulgated
Healthcare ETS, OSHA found that the
General Duty Clause was insufficient to
protect healthcare workers from the
grave danger they faced as well. 86 FR
32418. While OSHA initially attempted
to use the General Duty Clause to
protect employees across all industries
from COVID–19-related hazards,
OSHA’s experience has demonstrated
that the Clause is grossly inadequate to
protect employees covered by this ETS
from the grave danger posed by COVID–
19 in the workplace. As explained more
fully below, OSHA finds this ETS is
necessary to protect employees from the
hazards of COVID–19.
As an initial matter, the General Duty
Clause does not provide employers with
specific requirements to follow or a
roadmap for implementing appropriate
abatement measures. The ETS, however,
provides a clear statement of what
OSHA expects employers to do to
protect workers, thus facilitating better
compliance. The General Duty Clause is
so named because it imposes a general
duty to keep the workplace free of
recognized serious hazards; the ETS, in
contrast, lays out clear requirements for
employers to implement vaccination
policies including vaccination
verification, support for employee
vaccination, screening testing and face
coverings for unvaccinated workers, and
medical removal of COVID–19 positive
employees. Conveying obligations as
clearly and specifically as possible
makes it much more likely that
employers will comply with those
obligations and thereby protect workers
from COVID–19 hazards. See, e.g.,
Integra Health Mgmt., Inc., 2019 WL
1142920, at *7 n.10 (No. 13–1124, 2019)
(noting that standards ‘‘give clear notice
of what is required of the regulated
community’’); 56 FR 64007 (‘‘because
the standard is much more specific than
the current requirements [general
standards and the general duty clause],
employers and employees are given
more guidance in carrying out the goal
of reducing the risks of occupational
exposure to bloodborne pathogens’’).
Moreover, several characteristics of
General Duty Clause enforcement
actions make them an inadequate means
to address hazards associated with
COVID–19. First, it would be virtually
impossible for OSHA to require and
enforce the most important worker-
protective elements of the ETS (such as
vaccination and testing) under the
General Duty Clause. Second, OSHA’s
burden of proof for establishing a
General Duty Clause violation is heavier
than for standards violations. Third,
promulgating an ETS will enable OSHA
to issue more meaningful penalties for
willful and egregious violations, thus
creating effective deterrence against
employers who intentionally disregard
their obligations under the Act or
demonstrate plain indifference to
employee safety. As discussed in more
detail below, all of these considerations
demonstrate OSHA’s need to
promulgate this ETS in order to protect
unvaccinated workers covered by this
standard from hazards posed by
COVID–19.
The General Duty Clause is ill-suited to
requiring employers to adopt
vaccination and testing policies,
like those required by the ETS
Because the General Duty Clause
requires OSHA to establish the
existence and feasibility of abatement
measures that can materially reduce a
hazard, it is difficult for OSHA to use
the clause to require specific control
measures where an employer is doing
something, but not what the Secretary
has determined is needed to fully
address the serious hazard. See, e.g.,
Waldon Health Care Center, 16 BNA
OSHC 1052, 1993 WL 119662 at * (No.
89–2804, 1993) (vacating OSHA citation
requiring pre-exposure hepatitis B
vaccination under General Duty Clause
by finding that although vaccination
would more fully reduce the hazard, the
employer’s chosen means of abatement
were sufficient); Brown & Root, Inc.,
Power Plant Div., 8 BNA OSHC 2140,
1980 WL 10668 at *5 (No. 76–1296,
1980) (‘‘[T]he employer may defend
against a section 5(a)(1) citation by
asserting that it was using a method of
abatement other than the one suggested
by the Secretary.’’).
Further, even where OSHA
establishes a violation of the General
Duty Clause, the employer is under no
obligation to implement the feasible
means of abatement proven by OSHA as
part of its prima facie case. Cyrus Mines
Corp., 11 OSH Cas. (BNA) 1063, 1982
WL 22717, at *4 (No. 76–616, 1983)
(‘‘[The employer] is not required to
adopt the abatement method suggested
by the Secretary, even one found
feasible by the Commission; it may
satisfy its duty to comply with the
standard by using any feasible method
that is appropriate to abate the
violation.’’); Brown & Root, Inc., Power
Plant Div., 1980 WL 10668 at *5. Thus,
even in cases where OSHA prevails, the
employer need not necessarily
implement the specific abatement
measure(s) OSHA established would
materially reduce the hazard. The
employer could select alternative
controls and then it would be up to
OSHA, if it wished to cite the employer
again, to establish that the recognized
hazard continued to exist and that its
preferred controls could materially
reduce the hazard even further.
Given the severity and pervasiveness
of the COVID–19 hazard, OSHA has
determined that the specific abatement
measures provided in this ETS are
necessary to protect workers from grave
danger. Under the General Duty Clause
alone, it would be nearly impossible to
require employers to provide these
specific measures, and even then, it
could only be on a case-by-case
enforcement basis. Considering the
magnitude and ubiquity of the danger
that SARS–CoV–2 poses to workers
across the country, the case-by-case
adjudicatory regime set up through the
General Duty Clause is simply not
adequate to combat the risk of severe
illness and death caused by the virus.
General Duty Clause Citations Impose a
Heavy Litigation Burden on OSHA
Under the General Duty Clause OSHA
must prove that there is a recognized
hazard, i.e., a workplace condition or
practice to which employees are
exposed, creating the potential for death
or serious physical harm to employees.
See SeaWorld of Florida LLC v. Perez,
748 F.3d 1202, 1207 (D.C. Cir. 2014);
Integra Health Management, 2019 WL
1142920, at *5. Whether a particular
workplace condition or practice is a
‘‘recognized hazard’’ under the General
Duty Clause is a question of fact that
must be decided in each individual
case. See SeaWorld of Florida LLC, 748
F.3d at 1208. In the case of a COVID–
19-related citation, this means showing
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19 ‘‘The Act does not wait for an employee to die
or become injured. It authorizes the promulgation
of health and safety standards and the issuance of
citations in the hope that these will act to prevent
deaths and injuries from ever occurring.’’ Whirlpool
Corp, v. Marshall, 445 U.S. 1, 12 (1980); see also
Arkansas-Best Freight Sys., Inc. v. Occupational
Safety & Health Rev. Comm’n, 529 F.2d 649, 653
(8th Cir. 1976) (noting that the ‘‘[OSH] Act is
intended to prevent the first injury’’).
not just that the virus is a hazard as a
general matter—a fairly indisputable
point—but also that the specific
conditions in the cited workplace, such
as unvaccinated, unmasked employees
working in close proximity to other
employees for extended periods, create
a COVID–19-related hazard.
In contrast, an OSHA standard that
requires or prohibits specific conditions
or practices establishes the existence of
a hazard. See Harry C. Crooker & Sons,
Inc. v. Occupational Safety & Health
Rev. Comm’n, 537 F.3d 79, 85 (1st Cir.
2008); Bunge Corp. v. Sec’y of Labor,
638 F.2d 831, 834 (5th Cir. 1981). Thus,
in enforcement proceedings under
OSHA standards, as opposed to the
General Duty Clause, ‘‘the Secretary
need not prove that the violative
conditions are actually hazardous.’’
Modern Drop Forge Co. v. Sec’y of
Labor, 683 F.2d 1105, 1114 (7th Cir.
1982). With OSHA’s finding that the
hazard of exposure to COVID–19 can
exist for unvaccinated workers in all
covered workplaces (see Grave Danger,
Section III.A. of this preamble), the ETS
will eliminate the burden to repeatedly
prove, workplace by workplace, the
existence of a COVID–19 hazard under
the General Duty Clause.
One of the most significant
advantages to standards like the ETS
that establish the existence of the hazard
at the rulemaking stage is that the
Secretary can require specific abatement
measures without having to prove that
a specific cited workplace is already
hazardous.19 In contrast, as discussed
above, under the General Duty Clause
the Secretary cannot require abatement
before proving in the enforcement
proceeding that an existing condition at
the workplace is hazardous. For
example, in a challenge to OSHA’s
Grain Handling Standard, which was
promulgated in part to protect
employees from the risk of fire and
explosion from accumulations of grain
dust, the Fifth Circuit acknowledged
OSHA’s inability to effectively protect
employees from these hazards under the
General Duty Clause in upholding, in
large part, the standard. See Nat’l Grain
& Feed Ass’n v. Occupational Safety &
Health Admin., 866 F.2d 717, 721 (5th
Cir. 1988) (noting Secretary’s difficulty
in proving explosion hazards of grain
handling under General Duty Clause).
Although OSHA had attempted to
address fire and explosion hazards in
the grain handling industry under the
General Duty Clause, ‘‘employers
generally were successful in arguing
that OSHA had not proved that the
specific condition cited could cause a
fire or explosion.’’ Id. at 721 & n.6
(citing cases holding that OSHA failed
to establish a fire or explosion hazard
under the General Duty Clause). The
Grain Handling Standard, in contrast,
established specific limits on
accumulations of grain dust based on its
combustible and explosive nature, and
the standard allowed OSHA to cite
employers for exceeding those limits
without the need to prove at the
enforcement stage that each cited
accumulation was likely to cause a fire
or explosion. See id. at 725–26.
The same logic applies to COVID–19
hazards. Given OSHA’s burden under
the General Duty Clause to prove that
conditions at the cited workplace are
hazardous, it is difficult for OSHA to
ensure necessary abatement before
individual employee lives and health
are unnecessarily endangered by
exposure to COVID–19, despite
widespread evidence of the grave
danger posed by worker exposure to
COVID–19. Indeed, despite publishing a
voluminous collection of COVID–19
guidance online and receiving and
investigating thousands of complaints,
OSHA did not believe it could justify
the issuance of more than 20 COVID–19
related General Duty Clause citations
over the entire span of the pandemic so
far, because of the quantum of proof the
Secretary must amass under the General
Duty Clause. Unlike enforcement under
the General Duty Clause, this ETS
allows OSHA to cite employers for each
protective requirement they fail to
implement without the need to wait for
employee infection or death to prove in
an enforcement proceeding that the
particular cited workplace was
hazardous without that particular
measure in place. Thus, this ETS, which
covers millions of workers nation-wide,
is significantly preferable to the General
Duty Clause with respect to such a
highly transmissible virus because the
inability to prevent a single exposure
can quickly result in an exponential
increase in exposures and illnesses or
fatalities even at a single worksite.
An additional limitation of the
General Duty Clause is that proving that
there are feasible means to materially
reduce a recognized hazard typically
requires testimony from an expert
witness in each separate case, which
limits OSHA’s ability to prosecute these
cases as broadly as needed to protect
workers, in light of the expense
involved. See, e.g., Integra Health
Management, 2019 WL 1142920, at *13
(requiring expert witness to prove
proposed abatement measures would
materially reduce hazard). In contrast,
where an OSHA standard specifies the
means of compliance, the agency has
already made the necessary technical
determinations in the rulemaking and
therefore does not need to establish
feasibility of compliance as part of its
prima facie case in an enforcement
proceeding. See, e.g., A.J. McNulty & Co.
v. Sec’y of Labor, 283 F.3d 328, 334
(D.C. Cir. 2002); S. Colorado Prestress
Co. v. Occupational Safety & Health
Rev. Comm’n, 586 F.2d 1342, 1351 (10th
Cir. 1978). Preventing the initial
exposure and protecting as many
workers as quickly as possible is
especially critical in the context of
COVID–19 because, as explained in
Grave Danger, Section III.A. of this
preamble, it can spread so easily in
workplaces.
The ETS will also permit OSHA to
achieve meaningful deterrence
when necessary to address willful
or egregious failures to protect
employees against the COVID–19
hazard
As described above, in contrast to the
broad language of the General Duty
Clause, this ETS will prescribe specific
measures employers covered by this
standard must implement. This
specificity will make it easier for OSHA
to determine whether an employer has
intentionally disregarded its obligations
or exhibited a plain indifference to
employee safety or health. In such
instances, OSHA can classify the
citations as ‘‘willful,’’ allowing it to
propose higher penalties, with increased
deterrent effects. In promulgating the
Healthcare ETS, OSHA noted that early
in the pandemic, shifting guidance on
the safety measures employers should
take to protect their employees from
COVID–19 created ambiguity regarding
employers’ specific obligations. Thus,
OSHA could not readily determine
whether a particular employer had
‘‘intentionally’’ disregarded obligations
that were not yet clear. And, even as the
guidance began to stabilize, OSHA’s
ability to determine ‘‘intentional
disregard’’ or ‘‘plain indifference’’ was
difficult, for example, when an
employer took some steps address the
COVID–19 hazard. 86 FR 32420. The
Healthcare ETS largely resolved this
issue for employers covered by that
standard, by laying out clearly what
parameters to put in place to protect
healthcare workers. However, this
general challenge persists in OSHA’s
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attempts at enforcement in other
industries.
Further, OSHA has adopted its
‘‘egregious violation’’ policy to impose
sufficiently large penalties that achieve
appropriate deterrence against bad actor
employers who willfully disregard their
obligation to protect their employees
when certain aggravating circumstances
are present, such as a large number of
injuries or illnesses, bad faith, or an
extensive history of noncompliance
(OSHA Directive CPL 02–00–080
(October 21, 1990)). Its purpose is to
increase the deterrent impact of OSHA’s
enforcement activity. This policy
utilizes OSHA’s authority to issue a
separate penalty for each instance of
noncompliance with an OSHA standard,
such as each employee lacking the same
required protections, or each
workstation lacking the same required
controls. It can be more difficult to use
this policy under the General Duty
Clause because the Fifth Circuit and the
Occupational Safety and Health Review
Commission have held that, under the
General Duty Clause, OSHA may only
cite a hazardous condition once,
regardless of its scope or the number of
workers affected. Reich v. Arcadian
Corp., 110 F.3d 1192, 1199 (5th Cir.
1997). Thus, even where OSHA finds
that an employer willfully failed to
protect a large number of employees
from a COVID–19 hazard, OSHA might
not be able to cite the employer on a
per-instance basis for failing to protect
each of its employees. The provisions of
this ETS have been intentionally drafted
to make clear OSHA’s authority to
separately cite employers for each
instance of the employer’s failure to
protect employees and for each affected
employee, where appropriate.
By providing needed clarity, the ETS
will facilitate ‘‘willful’’ and ‘‘egregious’’
determinations that are critical
enforcement tools OSHA can use to
adequately address violations by
employers who have shown a conscious
disregard for the health and safety of
their workers in response to the
pandemic. Without the necessary
clarity, OSHA has been limited in its
ability to impose penalties high enough
to motivate the very large employers
who are unlikely to be deterred by
penalty assessments of tens of
thousands of dollars, but whose
noncompliance can endanger thousands
of workers. Indeed, OSHA has only been
able to issue two COVID–19-related
‘‘willful’’ citations and no ‘‘egregious’’
citations since the start of the pandemic
because of the challenges described
above.
For all of the reasons described above,
and after over a year of attempting to
use the General Duty Clause to address
this widespread hazard, OSHA finds
that the General Duty Clause is not an
adequate enforcement tool to protect
employees covered by this standard
from the grave danger posed by COVID–
19.
c. OSHA and Other Entity Guidance Is
Insufficient
OSHA has issued numerous non-
mandatory guidance products to advise
employers on how to protect workers
from SARS–CoV–2 infection (see
https://www.osha.gov/coronavirus).
Even the most comprehensive guidance
makes clear, as it must, that the
guidance itself imposes no new legal
obligations, and that its
recommendations are ‘‘advisory in
nature.’’ (See OSHA’s online guidance,
Protecting Workers: Guidance on
Mitigating and Preventing the Spread of
COVID–19 in the Workplace (OSHA,
Updated August 13, 2021); and OSHA’s
earlier 35-page booklet, Guidance on
Preparing Workplaces for COVID–19,
(OSHA, March 9, 2020)). This guidance,
as well as guidance products issued by
other government agencies and
organizations, including the CDC, the
Centers for Medicare & Medicaid
Services (CMS), the Institute of
Medicine (IOM), and the World Health
Organization (WHO), help protect
employees to the extent that employers
voluntarily choose to implement the
practices they recommend.
Unfortunately, OSHA’s experience and
the continued spread of COVID–19
throughout the country shows that does
not happen consistently or rigorously
enough, resulting in inadequate
protection for employees. For example,
the CDC has strongly recommended
vaccination since vaccines became
widely available earlier in the year, but
many employees have yet to take this
simple step, which would protect
themselves and their co-workers from
the danger of COVID–19.
As documented in numerous peer-
reviewed scientific publications, CDC,
IOM, and WHO have recognized a lack
of compliance with non-mandatory
recommended infection-control
practices (Siegel et al., 2007; IOM, 2009;
WHO, 2009). As noted in the preamble
to the Healthcare ETS, OSHA was aware
of these findings when it previously
concluded that an ETS was not
necessary, but at the time of that
conclusion, the agency erroneously
believed that it would be able to
effectively use the non-mandatory
guidance as a basis for establishing the
mandatory requirements of the General
Duty Clause, and informing employers
of their compliance obligations under
existing standards. 86 FR 32421. As
explained above, that has not proven to
be an effective strategy. Moreover, when
OSHA made its initial necessity
determination at the beginning of the
pandemic, it made an assumption that
given the unprecedented nature of the
COVID–19 pandemic, there would be an
unusual level of widespread voluntary
compliance by the regulated community
with COVID–19-related safety
guidelines. (See, e.g., DOL, May 29,
2020 at 20 (observing that ‘‘[n]ever in
the last century have the American
people been as mindful, wary, and
cautious about a health risk as they are
now with respect to COVID–19,’’ and
that many ‘‘protective measures are
being implemented voluntarily, as
reflected in a plethora of industry
guidelines, company-specific plans, and
other sources’’)).
Since that time, however,
developments have led OSHA to
conclude that the same uneven
compliance documented by CDC, IOM,
and WHO is also occurring for the
COVID–19 guidance issued by OSHA
and other agencies. For example, rising
‘‘COVID fatigue’’ or ‘‘pandemic fatigue’’
has been reported for nearly a year
already—i.e., a decrease in voluntary
use of COVID–19 mitigation measures
over time (Meichtry et al., October 26,
2020; Silva and Martin, November 14,
2020; Belanger and Leander, December
9, 2020; Millard, February 18, 2021).
Other reasons that people have not
followed COVID–19 guidance include
fear of financial loss; skepticism about
the danger posed by COVID–19; and
even a simple human tendency, called
‘‘psychological reactance,’’ to resist
curbs on personal freedoms, i.e., an urge
to do the opposite of what somebody
tells you to do (Belanger and Leander,
December 9, 2020; Markman, April 20,
2020). OSHA is seeing evidence of these
trends in its COVID–19 enforcement.
For example, although OSHA has issued
guidance since the spring of 2020
encouraging the use of physical
distancing and barriers as a means of
protecting employees at fixed work
locations, there have been a number of
news reports indicating that employers
ignore that guidance (Romo, November
19, 2020; Richards, May 5, 2020; Lynch,
July 9, 2020). This was evidenced by a
cross-sectional study performed from
late summer to early fall of 2020 in New
York and New Jersey that found non-
compliance and widespread
inconsistencies in COVID–19 response
programs (Koshy et al., February 4,
2021). Indeed, OSHA continues to
receive complaints and referrals
attesting to such workplace practices.
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(OSHA, October 17, 2021). Worse, some
employers must now deal with
employees who not only have yet to be
vaccinated but compound the danger by
hiding their unvaccinated status and
declining to wear source protection that
would identify them as unvaccinated,
even though it could provide some
protection to their coworkers, in
workplaces where there is a stigma
attached to being unvaccinated. (Ember
and Murphy Marcos, August 7, 2021).
This ETS contains notification and
vaccine verification requirements that
address these avoidant behaviors and
mitigate the hazard of undisclosed
exposure and transmission (see the
Summary and Explanation for
paragraphs (e), (g), and (h), Sections
VI.E., VI.G., and VI.H. of this preamble).
OSHA’s more recent guidance update
encourages employers to facilitate
employee vaccination by providing paid
time off and encourages testing and
masks for unvaccinated workers.
However, as discussed previously,
vaccination rates remain inconsistent
across the country and have slowed
significantly since the spring of 2021.
And infection rates remain high,
especially among the unvaccinated. It is
clear, as discussed previously, that
voluntary self-regulation by employers
will not sufficiently reduce the danger
that COVID–19 poses in workplaces
covered by this standard. As noted in
the White House Report on vaccination
requirements released on October 7, at
this time only 25% of businesses have
vaccine mandates in place (White
House, October 7, 2021). Since this ETS
and other federal efforts to require
vaccination were announced more
private and public sector institutions
have begun to prepare to implement
vaccination requirements, further
demonstrating the need for this rule as
an impetus for employer action (White
House, October 7, 2021).
The high number of COVID–19-
related complaints and reports that
OSHA continues to receive on a regular
basis suggests a lack of widespread
compliance with existing voluntary
guidance: From March 2020 to October
2021, OSHA has continued to receive
hundreds of COVID–19-related
complaints every month, including over
400 complaints during the month of
August 2021, and over 450 complaints
to date in the month of September
(OSHA, October 11, 2021). And, as of
October 17, OSHA has received 223
additional COVID–19-related
complaints. (OSHA, October 17, 2021).
If guidance were followed more strictly,
or if there were enough voluntary
compliance with steps to prevent
illness, OSHA would expect to see a
significant reduction in COVID–19-
related complaints from employees.
The dramatic increases in the
percentage of the population that
contracted the virus during the summer
of 2021 indicates a continued risk of
COVID–19 transmission in workplace
settings (for more information on the
prevalence of COVID–19 see Grave
Danger, Section III.A. of this preamble)
despite OSHA’s publication of
numerous specific and comprehensive
guidance documents. OSHA has found
that neither reliance on voluntary action
by employers nor OSHA non-mandatory
guidance is an adequate substitute for
specific, mandatory workplace
standards at the federal level. Public
Citizen v. Auchter, 702 F.2d 1150 at
1153 (voluntary action by employers
‘‘alerted and responsive’’ to new health
data is not an adequate substitute for
government action).
d. A Uniform Nationwide Response to
the Pandemic Is Necessary To Protect
Workers
As the pandemic has continued in the
United States, there has been increasing
recognition of the need for a more
consistent national approach (GAO,
September, 2020; Budryk, November 17,
2020; Horsley, May 1, 2020; DOL OIG,
February 25, 2021). Many employers
have advised OSHA that they would
welcome a nationwide ETS. For
example, in its October 9, 2020 petition
for a COVID–19 ETS, ORCHSE
Strategies, LLC explained that it is
‘‘imperative’’ that OSHA issue an ETS to
provide employers one standardized set
of requirements to address safety and
health for their workers (ORCHSE,
October 9, 2020). This group of
prominent business representatives
explained that an ETS would eliminate
confusion and unnecessary burden on
workplaces that are struggling to
understand how best to protect their
employees in the face of confusing and
differing requirements across states and
localities.
The lack of a national standard on this
hazard has led to increasing imbalance
in state and local regulation, a problem
that OSHA already identified as
concerning in its Healthcare ETS. See 86
FR 32413 (‘‘The resulting patchwork of
state and local regulations led to
inadequate and varying levels of
protection for workers across the
country, and has caused problems for
many employees and businesses.’’)
Since the Healthcare ETS was
published, states and localities have
taken increasingly more divergent
approaches to COVID–19 vaccination,
vaccination verification, screening
testing, and the use of face coverings in
the workplace. Currently, the spectrum
ranges from states and localities
requiring vaccine mandates and face
coverings to states prohibiting or
restricting them, with many states
falling somewhere in between. Due to
uneven approaches to vaccination
across the country, states with the
lowest rates of vaccination have
COVID–19 infection rates four times as
high as in states with the highest
vaccine rates. (Leonhardt, September 7,
2021). Given that thousands of working
age people continue to be infected with
COVID–19 each week, many of whom
will become hospitalized or die, OSHA
recognizes that a patchwork approach to
worker safety has not been successful in
mitigating this infectious disease
outbreak (CDC, October 18, 2021—
Cases, By Age). It has become clear that
a Federal standard, by way of this ETS,
is necessary to provide clear and
consistent protection to employees
across the country. As explained in
Pertinent Legal Authority (Section II. of
this preamble) and the Summary and
Explanation for paragraph (a) (Section
VI.A. of this preamble), OSHA has the
authority to comprehensively address
the issue(s) described in this ETS, and
the standard is intended to preempt
conflicting state and local laws.
In sum, based on its enforcement
experience during the pandemic to date,
OSHA concludes that continued
reliance on existing standards and
regulations, the General Duty Clause,
and guidance, in lieu of an ETS, is not
adequate to protect unvaccinated
employees from the grave danger of
being infected by, and suffering death or
serious health consequences from,
COVID–19.
References
Belanger J and Leander P. (2020, December
9). What Motivates COVID Rule
Breakers? Scientific American. https://
www.scientificamerican.com/article/
what-motivates-covid-rule-breakers/.
(Belanger and Leander, December 9,
2020)
Budryk Z. (2020, November 17). Fauci calls
for ‘a uniform approach’ to coronavirus
pandemic. The Hill. https://thehill.com/
policy/healthcare/526378-fauci-calls-for-
a-uniform-approach-to-the-coronavirus-
pandemic?rl=1. (Budryk, November 17,
2020)
Centers for Disease Control and Prevention
(CDC). (2021, September 9). Your
COVID–19 Vaccination. https://
www.cdc.gov/coronavirus/2019-ncov/
vaccines/your-vaccination.html. (CDC,
September 9, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, October 18). COVID Data
Tracker. https://covid.cdc.gov/covid-
data-tracker/. (CDC, October 18, 2021)
VerDate Sep<11>2014
22:27 Nov 04, 2021
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61446
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
Ember S and Murphy Marcos C. (2021,
August 7). They Don’t Want the Shot.
They Don’t Want Colleagues to Know.
The New York Times. https://
www.nytimes.com/2021/08/07/business/
workplace-vaccinations-coronavirus-
reopenings.html. (Ember and Murphy
Marcos, August 7, 2021)
Government Accountability Office (GAO).
(2020, September). COVID–19: Federal
Efforts Could Be Strengthened by Timely
and Concerted Actions. https://
www.gao.gov/assets/710/709934.pdf.
(GAO, September 2020)
Horsley S. (2020, May 1). U.S. Workplace
Safety Rules Missing in the Pandemic.
National Public Radio. https://
www.npr.org/2020/05/01/849212026/it-
s-the-wild-west-u-s-workplace-safety-
rules-missing-in-the-pandemic. (Horsley,
May 1, 2020)
Institute of Medicine (IOM). (2009).
Respiratory Protection for Healthcare
Workers in a Workplace Against Novel
H1N1 Influenza A: A letter report. The
National Academies Press. http://
www.nap.edu/catalog/12748.html. (IOM,
2009)
Kaiser Family Foundation (KFF). (2021,
October 6). Latest Data on COVID–19
Vaccinations by Race/Ethnicity. https://
www.kff.org/coronavirus-covid-19/issue-
brief/latest-data-on-covid-19-
vaccinations-by-race-ethnicity/. (KFF,
October 6, 2021)
Koshy K et al., (February 4, 2021).
Perspectives of region II OSHA
authorized safety and health trainers
about initial COVID–19 response
programs. Safety Science 138. https://
doi.org/10.1016/j.ssci.2021.105193.
(Koshy et al., February 4, 2021)
Leonhardt D. (2021, September 7). One in
5,000. The New York Times. https://
www.nytimes.com/2021/09/07/briefing/
risk-breakthrough-infections-delta.html.
(Leonhardt, September 7, 2021)
Lynch R. (2020, July 9). Orange County to
crack down on gyms that ignore Covid-
19 safety guidelines. Orlando Business
Journal. https://www.bizjournals.com/
orlando/news/2020/07/09/orange-
county-gyms-could-face-scrutiny-for-
not.html. (Lynch, July 9, 2020)
Markman A. (2020, April 20). Why are there
still so many coronavirus skeptics? Fast
Company. https://
www.fastcompany.com/90492518/why-
are-there-still-so-many-coronavirus-
skeptics. (Markman, April 20, 2020)
McPhillips D and Cohen E. (2021, May 19).
Uneven vaccination rates across the US
linked to COVID–19 case trends, worry
experts. CNN Health. https://
www.cnn.com/2021/05/19/health/
uneven-vaccination-rates-covid-19-
trends/index.html. (McPhillips and
Cohen, May 19, 2021)
Meichtry S et al. (2020, October 26).
Pandemic Fatigue is Real—And It’s
Spreading; Collective exhaustion with
coronavirus restrictions has emerged as a
formidable adversary for governments.
The Wall Street Journal. https://
www.wsj.com/articles/pandemic-fatigue-
is-realand-its-spreading-11603704601.
(Meichtry et al., October 26, 2020)
Millard E. (2021, February 18). How to not
let pandemic fatigue turn into pandemic
burnout. Everyday Health. https://
www.everydayhealth.com/coronavirus/
how-to-not-let-pandemic-fatigue-turn-
into-pandemic-burnout/. (Millard,
February 18, 2021)
Occupational Safety and Health
Administration (OSHA). (2020, March 9).
Guidance on Preparing Workplaces for
Covid-19. https://www.osha.gov/sites/
default/files/publications/
OSHA3990.pdf. (OSHA, March 9, 2020
Occupational Safety and Health
Administration (OSHA). (2021, July 7).
Updated Interim Enforcement Response
Plan for Coronavirus Disease 2019
(COVID–19). https://www.osha.gov/laws-
regs/standardinterpretations/2021–07–
07. (OSHA, July 7, 2021)
Occupational Safety and Health
Administration (OSHA). (2021, August
13). Guidance on Preparing Workplaces
for Covid-19. https://www.osha.gov/
sites/default/files/publications/
OSHA3990.pdf. (OSHA, August 13,
2021)
Occupational Safety and Health
Administration (OSHA). (2021, August
13). Protecting Workers: Guidance on
Mitigating and Preventing the Spread of
COVID–19 in the Workplace. https://
www.osha.gov/coronavirus/safework.
(OSHA, Updated August 13, 2021)
Occupational Safety and Health
Administration (OSHA). (2021, October
17). Summary Data for Federal and State
Programs—Enforcement. https://
www.osha.gov/enforcement/covid-19-
data#complaints_referrals. (OSHA,
October 17, 2021)
ORCHSE Strategies. (2020, October 9).
‘‘Petition to the U.S. Department of
Labor—Occupational Safety and Health
Administration (OSHA) for an
Emergency Temporary Standard (ETS)
for Infectious Disease.’’ (ORCHSE,
October 9, 2020)
Richards C. (2020, May 5). 2 Utah County
businesses told staff to ignore COVID–19
guidelines, resulting in 68 positive cases.
Daily Herald. https://
www.heraldextra.com/news/local/2-
utah-county-businesses-told-staff-to-
ignore-covid-19-guidelines-resulting-in-
68-positive/article_d8426991-a693-5879-
9d88-f9e094aef5b5.html. (Richards, May
5, 2020)
Romo V. (2020, November 19). Tyson
managers suspended after allegedly
betting if workers would contract
COVID. National Public Radio. https://
www.npr.org/2020/11/19/936905707/
tyson-managers-suspended-after-
allegedly-betting-if-workers-would-
contract-covid. (Romo, November 19,
2020)
Siegel J, Rhinehart E, Jackson M, Chiarello L,
and the Healthcare Infection Control
Practices Advisory Committee. (2007).
2007 Guideline for isolation precautions:
Preventing transmission of infectious
agents in healthcare settings. https://
www.cdc.gov/infectioncontrol/pdf/
guidelines/isolation-guidelines-H.pdf.
(Siegel et al., 2007)
Silva C and Martin M. (2020, November 14).
U.S. Surgeon General Blames ‘‘Pandemic
Fatigue’’ for Recent COVID–19 Surge.
NPR. https://www.npr.org/sections/
coronavirus-live-updates/2020/11/14/
934986232/u-s-surgeon-general-blames-
pandemic-fatigue-for-recent-covid-19-
surge. (Silva and Martin, November 14,
2020)
United States Department of Labor (DOL) and
Office of the Inspector General (OIG).
(2021, February 25). COVID–19:
Increased Worksite Complaints and
Reduced OSHA Inspections Leave U.S.
Workers’ Safety at Increased Risk. http://
www.oig.dol.gov/public/reports/oa/2021/
19-21-003-10-105.pdf. (DOL OIG,
February 25, 2021)
United States Department of Labor (DOL).
(2020, May 29). In Re: American
Federation Of Labor And Congress Of
Industrial Organizations. Department Of
Labor’s Response to the Emergency
Petition for a Writ of Mandamus, No. 20–
1158 (D.C. Cir., May 29, 2020). (DOL,
May 29, 2020)
White House. (2021, October 7). White House
Report: Vaccination requirements are
helping vaccinate more people, protect
Americans from COVID–19, and
strengthen the economy. https://
www.whitehouse.gov/wp-content/
uploads/2021/10/Vaccination-
Requirements-Report.pdf. (White House,
October 7, 2021)
World Health Organization (WHO). (2009).
WHO Guidelines on Hand Hygiene in
Health Care: A Summary—First Global
Patient Safety Challenge Clean Care is
Safer Care. https://
www.ncbi.nlm.nih.gov/books/
NBK144013/pdf/Bookshelf_
NBK144013.pdf. (WHO, 2009)
IV. Conclusion
This pandemic continues to take a
massive toll on American society, and
addressing it requires a comprehensive
national response. This ETS is part of
that response. OSHA shares the nation’s
hope for the promise of recovery created
by the vaccines. But in the meantime, it
recognizes that we have not yet
succeeded in defeating the virus, and
that many workers across the country
are in grave danger. Therefore, this ETS,
with mitigation measures emphasizing
worker vaccination, is necessary.
Although OSHA finds it necessary to
institute specific mitigation measures
for the immediate future, the agency can
adjust as conditions change. Even after
issuing an ETS, OSHA retains the
flexibility to update the ETS to adjust to
the subsequent evolution of CDC
workplace guidance. This ETS
addresses (and incorporates as a main
component) the major development in
infection control over the last year—the
development and growing
implementation of COVID–19 vaccines.
Going forward, further developments
can be addressed through OSHA’s
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20 While OSHA references several employers’
policies, this is not intended to serve as an
endorsement of those plans or an indication that
those plans comply with the ETS. Rather, the plans
and best practice documents show that developing
and implementing policies to address employee
COVID–19 vaccination in various workplaces is
capable of being done in a variety of industries, and
therefore, compliance with the ETS is
technologically feasible.
authority to modify the ETS if needed,
or to terminate it entirely if vaccination
and other efforts end the current
emergency. However, at this point in
time, the available evidence indicates
that the ETS is necessary to protect
unvaccinated employees across the
country from the grave danger of
COVID–19.
IV. Feasibility
A. Technological Feasibility
This section presents an overview of
the technological feasibility assessment
for OSHA’s Emergency Temporary
Standard (ETS) for COVID–19 that
requires all employers with 100 or more
employees to ensure that all employees
are fully vaccinated unless they
implement a policy requiring employees
to undergo testing for COVID–19 at least
once every seven days and wear face
coverings.
Technological feasibility has been
interpreted broadly to mean ‘‘capable of
being done’’ (Am. Textile Mfrs. Inst. v.
Donovan, 452 U.S. 490, 509–510
(1981)). A standard is technologically
feasible if the protective measures it
requires already exist, can be brought
into existence with available
technology, or can be created with
technology that can reasonably be
expected to be developed, i.e.,
technology that ‘‘looms on today’s
horizon’’ (United Steelworkers of Am.,
AFL–CIO–CLC v. Marshall, 647 F.2d
1189, 1272 (D.C. Cir. 1980) (Lead I));
Amer. Iron & Steel Inst. v. OSHA, 939
F.2d 975, 980 (D.C. Cir. 1991) (Lead II);
American Iron and Steel Inst. v. OSHA,
577 F.2d 825 (3d Cir. 1978)). Courts
have also interpreted technological
feasibility to mean that a typical firm in
each affected industry or application
group will reasonably be able to
implement the requirements of the
standard in most operations most of the
time (see Public Citizen v. OSHA, 557
F.3d 165 (3d Cir. 2009); Lead I, 647 F.2d
at 1272; Lead II, 939 F.2d at 990).
OSHA issued an ETS in June 2021 to
protect healthcare and healthcare
support employees in covered
healthcare settings from exposure to
SARS–CoV–2. See 86 FR 32376 (June
21, 2021) (Healthcare ETS). OSHA
found the requirements in that ETS to
be technologically feasible, including a
requirement for employers to pay for
vaccination of employees that is very
similar to the requirement in this new
ETS. OSHA’s finding that the
Healthcare ETS was technologically
feasible was primarily based on
available evidence showing that most
healthcare employers, and employers
across all industry sectors, had already
implemented, or were in process of
implementing, procedures similar to
those required by the Healthcare ETS.
Similarly, OSHA’s feasibility findings
for this ETS are based on evidence that
vaccination and testing policies, along
with the use of face coverings consistent
with recommendations from the CDC,
have been implemented in multiple
industry sectors as testing and
vaccinations were made more widely
available during the course of the
pandemic.
As discussed in Summary and
Explanation (Section VI. of this
preamble), this ETS for vaccination and
testing applies to all employers with 100
or more employees, except as noted
here. It does not apply to workplaces
covered under the Safer Federal
Workforce Task Force COVID–19
Workplace Safety: Guidance for Federal
Contractors and Subcontractors or
settings where any employee provides
healthcare services or healthcare
support services when subject to the
requirements of the Healthcare ETS (29
CFR 1910.502). It also does not apply to
employees who do not report to a
workplace where other individuals such
as coworkers or customers are present,
employees while they are working from
home, or employees who work
exclusively outdoors.
As noted above, OSHA has the legal
duty to demonstrate that the average
employer covered by this ETS can
comply with that standard in most
operations most of the time. This legal
analysis is therefore focused solely on
whether employers with 100 or more
employees can comply with the
standard. OSHA’s rationale for that
scope threshold of 100 or more
employees is explained in the Summary
and Explanation for paragraph (b),
Section VI.B. of this preamble.
As discussed below, OSHA finds no
technological feasibility barriers related
to compliance with the requirements in
the ETS. These requirements include
establishing and implementing a written
mandatory COVID–19 vaccination
policy or alternative policy requiring
testing and face coverings; determining
employee vaccination status; supporting
employee vaccination by providing paid
time for vaccination and time off for
recovery; ensuring that employees who
are not fully vaccinated are tested for
COVID–19 at least once every seven
days and wear face coverings; and
recordkeeping for employee vaccination
status and testing.
OSHA reviewed numerous large-scale
employer surveys and vaccination and
testing policies developed by
employers, public health organizations,
trade association, and local, state, and
federal governmental bodies. While
OSHA discusses several examples of
these plans and policies below,20
OSHA’s feasibility determination is
based on all evidence in the rulemaking
record. The majority of the survey data
and other publicly available material
that OSHA reviewed pertains to large
employers with 100 or more employees.
Additionally, OSHA thoroughly
reviewed current and future projections
of the availability of COVID–19 tests,
testing supplies, and laboratory
capacity. Based on a review of
vaccination and testing policies among
large employers, OSHA has determined
that most employers covered by this
standard across a wide range of
industries have either already
implemented vaccination and testing
programs and require unvaccinated
employees to wear face coverings, or are
capable of implementing programs that
comply with the requirements in the
ETS most of the time. OSHA therefore
finds that the standard is
technologically feasible.
I. Employer Policy on Vaccination
Paragraph (d)(1) of the ETS requires
each covered employer to establish and
implement a written mandatory
vaccination policy unless the employer
adopts an alternative policy requiring
COVID–19 testing and face coverings for
unvaccinated employees, which is
discussed later. To meet the definition
of ‘‘mandatory vaccination policy’’
under paragraph (c), the policy must
require: Vaccination of all employees,
including all new employees as soon as
practicable, other than those employees
(1) for whom a vaccine is medically
contraindicated, (2) for whom medical
necessity requires a delay in
vaccination, or (3) those legally entitled
to a reasonable accommodation under
federal civil rights laws because they
have a disability or sincerely-held
religious beliefs, practices, or
observances that conflict with the
vaccination requirement.
OSHA requires employers to
implement a mandatory vaccination
requirement, but provides an exemption
for an alternative policy that allows
employees to choose either to be fully
vaccinated or to be regularly tested and
wear a face covering. This compliance
options mean that the ETS is
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21 https://www.healthaction.org/resources/
vaccines/covid-19-vaccines-employer-requirements-
health-action-alliance?0405d6f4_page=1 (last
visited October 2, 2021).
technologically feasible if employers
across various industries are capable of
implementing either policy, but
nevertheless OSHA analyzes both
employer policy options to demonstrate
that there are no significant
technological barriers to either
approach.
OSHA reviewed several large-scale
employer surveys related to vaccination
policies across the country covering a
wide range of industry sectors. Surveys
conducted by Arizona State University
(ASU) and the World Economic Forum
(WEF), called COVID–19 Workplace
Commons—Keeping Workers Well,
show that most employers already have
some type of vaccination policy, with
more than 60 percent of surveyed
employers requiring vaccinations for
some or all employees. These survey
results further support OSHA’s
determination that the vaccination
policy requirement is feasible.
The ASU WEF workplace COVID–19
surveys collected information from
employers across industry sectors about
their response to the COVID–19
pandemic. The results and responses
from more than 1,400 companies are
publicly available through the ASU
College of Health Solutions web page
COVID–19 Diagnostics Commons (ASU,
October 5, 2021). Case studies from
employers are also available within the
interactive dashboard on that web page.
The surveys consisted of numerous
questions about workplace pandemic
response, including questions related to
vaccination policies and testing
unvaccinated employees.
The most recent COVID–19 survey
data was collected between August 2,
2021 and August 20, 2021 and reported
in September 2021 (accessible through
the COVID–19 Workplace Commons).
More than 1,400 companies operating
1143 facilities in 23 industry sectors
were part of the survey, the majority of
which are companies of the size covered
by the ETS. Ninety percent of facilities
surveyed had 100 or more employees at
their facilities, and 56% had more than
100 but less than 1,000 employees at
their facilities. The industry sectors
surveyed include: Technology and
software; business and professional
services; manufacturing; construction;
healthcare, hospitals, and clinics; retail
stores; retail food stores; consumer retail
service; energy and utilities; nonprofit
organizations; education (colleges and
universities); education (pre-K to 12);
real estate and property management;
agriculture and food production;
healthcare services; media and
entertainment; government and quasi-
public; biotech, pharmaceuticals, and
diagnostics; restaurants and food
service; hotels and casinos;
transportation, distribution, and
logistics; consumer transportation; and
recreation (ASU WEF, September 2021).
The survey responses related to
vaccination policies support OSHA’s
determination that it is feasible for
covered employers to implement
mandatory COVID–19 vaccination
policies. The survey results showed that
45% of employers surveyed require all
employees to be vaccinated against
COVID–19, and an additional 16%
require some of its employees to be
vaccinated against COVID–19. (ASU
WEF, September 2021). Only three
percent of employers surveyed did not
have a vaccination policy at the time
(ASU WEF, September 2021). While this
survey covers a wide range of industries
it may not represent the percentage of
companies implementing mandatory
vaccination policies in general
populations but for the feasibility
purposes it demonstrates that it has and
can be done.
OSHA also reviewed slightly older
survey data, which, even though it
shows somewhat lower rates of
employer vaccination mandates, still
supports OSHA’s finding that such
vaccination polices are feasible. In late
June 2021, the National Safety Council
(NSC) conducted three national surveys,
one organizational and two workforce,
of private companies, nonprofits, legal
experts, public health professionals,
medical professionals and government
agencies that have addressed workforce
COVID–19 vaccinations based on best
practices and proven workplace safety
strategies. The survey results show that
many employers and organizations are
currently requiring employees to be
vaccinated.
The three surveys were distributed to
300 employers and organizations across
the country and from a wide range of
industries to collect data on pandemic
response, including implementation of
COVID–19 vaccine policies and testing
among their workforce. Of the
employers and organizations surveyed
in June 2021, the NSC found that 20%
were implementing some form of a
worker vaccination requirement. While
OSHA believes that the ASU WEF
surveys (which included more
employers and are more recent) are
better indicators of current employer
vaccination policies, the NSC surveys
also support the feasibility of employer
vaccination mandates (NSC, September
2021)
The NSC, in partnership with the
Health Action Alliance (HAA) and the
Centers for Disease Control and
Prevention (CDC), have developed a
multifaceted, comprehensive effort
called SAFER, aimed at helping
employers prioritize health and safety as
they develop plans and polices for their
employees to return to the workplace
(NSC, May 17, 2021). Through SAFER,
the NSC and HAA developed a web-
based decision tool to guide employers
on health, legal, and other
considerations to prioritize the health
and safety of workers. Due to the Delta
Variant surge of new COVID–19 cases
across the United States, the NSC and
HAA revised the SAFER resources,
including the online tool, to include
information about employer
requirements for COVID–19
vaccinations. These include guides for
developing plans and policies to
support employee vaccination through
mandates and incentives; the collection
and maintenance of COVID–19
vaccination records; and various
considerations for testing unvaccinated
workers. (HAA and NSC, September 17,
2021). The availability of these publicly-
accessible tools to help employers
develop vaccination policies further
reduces any potential barriers for
covered employers to establish and
implement a written policy requiring
each employee to be fully vaccinated
against COVID–19, or alternatively to
establish a policy allowing employees to
choose whether to be fully vaccinated or
tested for COVID–19 at least every seven
days and wear face coverings.
The HAA maintains an online list of
large companies requiring vaccinations
for all or part of their workforce or
customers. OSHA reviewed the list of
companies, drawn from news reports
and employer websites, with
requirements for COVID–19 vaccination.
Most of the companies listed require
some or all employees to be vaccinated
against COVID–19 while allowing
medical exemptions or reasonable
accommodations for disability or
religious reasons. There are currently
188 listed companies across numerous
industry sectors, including Amtrak,
Deloitte, Google, The Walt Disney
Company, Walmart, and the U.S.
Chamber of Commerce.21
While healthcare employers subject to
29 CFR 1910.502 are not covered by this
ETS, a number of large healthcare
employers have implemented
mandatory vaccine policies. This also
shows the feasibility of the employers
implementing mandatory vaccination
requirements, often on large scales.
According to the American Hospital
Association (AHA), over 1,800 hospitals
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have one or more vaccination
requirements in place (Becker’s Hospital
Review, October 11, 2021). Large
healthcare employers mandating that
their employees be vaccinated include
Kaiser Permanente, the nation’s largest
integrated, nonprofit health care
organization with more than 216,000
employees and more than 23,000
physicians (Kaiser Permanente, August
2, 2021); Trinity Health, one of the
largest multi-institutional Catholic
health care delivery systems in the
nation, with more than 123,000
employees and 90 hospitals in 22 states
(Trinity Health, July 8, 2021); Sanford
Health, which operates in 26 states and
employs nearly 50,000 people (Sanford
Health, July 22, 2021); and Genesis
Health Care, a large U.S. nursing home
chain with over 40,000 employees
working in more than 250 centers across
23 states (Genesis Health Care,
September 29, 2021).
Under paragraph (d)(2), if employers
do not establish and implement a
written mandatory vaccination policy,
the employer must establish and
implement a written policy allowing
any employees not subject to a
mandatory vaccination policy to either
choose to be fully vaccinated or
regularly tested for COVID–19 and wear
a face covering. A substantial number of
employers already have such policies in
place. For example, the ASU WEF
survey shows that 30% of employers
surveyed require unvaccinated
employees to participate in mandatory
COVID–19 testing and 30% of
employers require face coverings for
unvaccinated employees (ASU WEF,
September 2021).
OSHA also notes a number of state
COVID–19 vaccination requirements. In
response to the Delta Variant surge, 19
states have implemented written
COVID–19 vaccination and testing
policies for state employees and 23
states have done so for healthcare
employees (NASHP, October 1, 2021).
For example, on September 20, 2021,
the Colorado Department of Public
Health and Environment (CDPHE)
implemented policies requiring state
employees and personnel at health care
facilities and hospitals to be fully
vaccinated against COVID–19. All state
employees must either be fully
vaccinated against COVID–19 or
participate in twice-weekly testing.
Employees are allowed work time to get
tested and administrative or Public
Health Emergency Leave to get
vaccinated. Employees who are not fully
vaccinated must wear masks inside state
facilities when they are around others.
On August 30, 2021, the State Board of
Health approved a vaccine requirement
for personnel in health care settings
with high-risk patients. All personnel
affected by this rule needed to receive
their first dose of COVID–19 vaccine by
September 30, 2021, and must be fully
vaccinated by October 31, 2021 (CDPHE,
September 17, 2021).
A number of local governments have
also implemented policies requiring
COVID–19 vaccination or testing for
employees. For example, the Fulton
County Board of Commissioners in
Georgia recently approved a ‘‘Vax or
Test’’ policy requiring employees to get
vaccinated or tested for COVID–19 each
week. Since September 6, 2021, Fulton
County has required all County
employees, as a condition of
employment, to either be vaccinated
against COVID–19 or be tested weekly
for COVID–19 unless an employee is
granted a reasonable accommodation
(Fulton County Government, September
03, 2021). The multitude of local, state,
and employer vaccination or testing
mandates across the country support
OSHA’s finding that such policies are
feasible.
II. Determining Employee Vaccination
Status
Paragraph (e) of the ETS requires
employers to determine the vaccination
status of each employee. Employers
must require employees to provide an
acceptable proof of vaccination status,
including whether they are fully or
partially vaccinated. As discussed in
Summary and Explanation (Section VI.
of this preamble), acceptable proof of
vaccination status is: (i) The record of
immunization from a health care
provider or pharmacy; (ii) a copy of the
COVID–19 Vaccination Record Card;
(iii) a copy of medical records
documenting the vaccination; (iv) a
copy of immunization records from a
public health, state, or tribal
immunization information system; or a
copy of any other official
documentation that contains the type of
vaccine administered, date(s) of
administration, and the name of the
health care professional(s) or clinic
site(s) administering the vaccine(s). A
signed and dated employee attestation is
acceptable in instances when an
employee is unable to produce proof of
vaccination. Given the attestation
option, there are no technological
barriers to the provision for proof of
vaccination status. As discussed below,
many employers requiring proof of
vaccination have successfully
implemented such policies even
without allowing the flexibility of the
attestation option.
The employer must maintain a record
and a roster of each employee’s
vaccination status. This information is
subject to applicable legal requirements
for confidentiality of medical
information. These records must be
preserved while the ETS is in effect.
OSHA is not aware of any technological
challenges that the large employers
covered by this ETS would face with
respect to collecting and maintaining
records. This is a performance-based
requirement, meaning that employers
have the flexibility to structure their
systems to fit within current systems,
such as those relating to personnel
records, tax records, and other sensitive
or confidential records gathered and
maintained by large employers.
A number of the surveys discussed
above also show that most employers
with vaccine mandates require proof of
vaccination. For example, ASU WEF
workplace COVID–19 survey from fall
2021 found that 60% of employers that
required vaccinations also required
proof of vaccination from employees.
The NSC study from June 2021 found
that 45% of employers with COVID–19
vaccination requirements required proof
of vaccination, such as submitting a
copy of the COVID–19 vaccination card.
An additional 30% of employers
surveyed verify employee vaccination
status through self-reporting based on
the honor system.
Additionally, a large-scale survey
conducted by the Willis Towers Watson
consulting firm between August 18 and
25, 2021, showed that a majority of
employers currently track their
employees’ vaccination status. Nearly
one thousand employers responded to
this survey, and they collectively
employ 9.7 million workers from
industries across the public and private
sectors including manufacturing,
general services, wholesale and retail, IT
and telecom, healthcare, financial
services, energy and utilities, and public
sector and education (Willis Towers
Watson, June 23, 2021). Nearly six in 10
(59%) currently track their workers’
vaccination status and another 19% are
planning or considering doing so later
this year. A majority (62%) of those
employers who currently track their
workers’ vaccination status require
proof of vaccination, such as CDC
vaccination cards, while 36% rely on
employees to self-report (Willis Towers
Watson, September 1, 2021).
Other evidence in the record also
supports the feasibility both of gathering
proof of vaccination and determining
employees’ vaccination status. Many
large employers with vaccination
policies require employees to submit
proof of vaccination. For example,
Tyson Foods requires employees to
submit proof of vaccination to Tyson
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Foods Vaccination Verification Program
in order to qualify for the company’s
vaccination incentive (Tyson Foods,
August 3, 2021). Similarly, Capital One
bank requires all employees,
contractors, vendors, and visitors to
Capital One facilities to show proof of
vaccination. (Capital One, August 11,
2021). The International Union of
Painters and Allied Trades (IUPAT),
which represents 140,000 craftspeople
in the U.S. and Canada and has
implemented vaccine requirements for
its members, also requires all of its own
non–bargaining unit office and field
employees to show proof of vaccination.
(IUPAT, May 10, 2021).
CVS Health, a health conglomerate
with more than 300,000 employees,
including more than 40,000 physicians,
pharmacists, nurses and nurse
practitioners, has mandated COVID–19
vaccination for its nurses, pharmacists
and other employees who interact with
patients and requires proof of
vaccination for those employees (CVS
Health, August 23, 2021).
The surveys and employer policies
reviewed by OSHA all support the
agency’s finding that it is feasible for
employers to determine their
employees’ vaccination status and
collect proof of vaccination.
III. Providing Support for Vaccination
Paragraph (f) of the ETS requires
employers to support COVID–19
vaccination for each employee by
providing a reasonable amount of time
to each employee for vaccination and
reasonable time and paid sick leave to
each employee for side effects
experienced following vaccination. The
feasibility of paying for the time is
addressed in OSHA’s economic
analysis.
This technological feasibility
determination focuses on whether
employers would encounter obstacles in
implementing payment policies that
would make this requirement infeasible
for the large employers covered by this
ETS. OSHA has determined that there
are no such obstacles. Most
significantly, OSHA has already
required this type of system for
employers covered by the Healthcare
ETS and nearly four months after that
ETS took effect, OSHA is not aware that
employers covered by that ETS
experienced any technological
compliance difficulties with respect to
that requirement. In addition, many
employers have already implemented
policies such as those required to
comply with this new ETS as a way of
incentivizing employee vaccination. For
example, the ASU WEF workplace
COVID–19 survey from fall 2021 found
that 60% of employers surveyed offered
incentives for employees to be
vaccinated. These incentives ranged
from additional paid time off, cash, the
ability to bypass regular testing and/or
daily health screening requirements,
and gifts. Eighteen percent of surveyed
employers already provide additional
time off for COVID–19 vaccination.
Moreover, the NSC survey found that
86% of surveyed organizations had
implemented policies such as paid time
off, assistance with scheduling and
transportation, and/or onsite
vaccination.
OSHA’s review of plans and best
practice documents from the HAA
registry and from other publicly-
available sources also inform OSHA’s
finding that it is feasible for large
employers to support employee
vaccination (HAA, October 10, 2021).
As part of this review, OSHA analyzed
the ways that employers are currently
supporting employee vaccination. One
employer in the restaurant industry, the
Fifty/50 Group, a Chicago-based
restaurant group comprised of 14
establishments that requires employees
to be fully vaccinated, offers paid time
off for anyone getting a vaccine or
feeling the mild after-effects. (Fifty/50
Group, May 18, 2021). Another
employer in the animal slaughtering and
processing industry, Tyson Foods,
requires COVID–19 vaccinations for its
U.S. workforce and also offers $200 and
up to four hours of regular pay if
employees are vaccinated outside of
their normal shift or through an external
source (Tyson Foods, August 3, 2021).
In addition, Tyson Foods supports
onsite vaccination events in
collaboration with local health
departments and healthcare providers to
improve accessibility to vaccination.
Tyson Foods has hosted more than 100
vaccination events at its locations across
the country.
The evidence in the record
demonstrates that many employers are
already offering the types of vaccination
support required by paragraph (f).
Combined with OSHA’s previous
finding for a similar provision in the
Healthcare ETS and the lack of
compliance difficulties reported while
that ETS has been in effect, OSHA
therefore finds this requirement is
technologically feasible.
IV. COVID–19 Testing for Employees
Who Are Not Fully Vaccinated
Paragraph (g) of the ETS requires
employers to ensure that employees
who are not fully vaccinated and who
report at least once every seven days to
a workplace where other individuals
such as coworkers or customers are
present are: (1) Tested for COVID–19 at
least once every seven days; and (2)
provide documentation of the most
recent COVID–19 test result to the
employer no later than the seventh day
following the date the employee last
provided a test result. Employers must
also ensure that employees who are not
fully vaccinated and do not report
during a period of seven or more days
to a workplace where other individuals
are present are: (1) Tested for COVID–
19 within seven days prior to returning
to the workplace; and (2) provide
documentation of that test result upon
return to the workplace.
Employees who are not fully
vaccinated must be tested with a
COVID–19 test, which is a test for
SARS–CoV–2 that is: (i) Cleared,
approved, or authorized, including in an
Emergency Use Authorization (EUA) by
the U.S. Food and Drug Administration
(FDA) to detect current infection with
the SARS–CoV–2 virus (e.g., a viral
test); (ii) administered in accordance
with the authorized instructions; and
(iii) not both self-administered and self-
read unless observed by the employer or
an authorized telehealth proctor.
Examples of tests that satisfy this
requirement include tests with
specimens that are processed by a
laboratory (including home or on-site
collected specimens which are
processed either individually or as
pooled specimens), proctored over-the-
counter tests, point of care tests, and
tests where specimen collection is either
done or observed by an employer.
COVID–19 testing has become more
widely available throughout the
pandemic and as of September 2021, the
FDA has authorized approximately 250
tests and collection kits that diagnose
current infection with the SARS–
CoV–2 virus and may be acceptable
under the ETS (FDA, September 10,
2021), and by October 1, 2021, the
number of EUAs issued had grown to
324 (FDA, October 1, 2021). The ETS
permits compliance through use of a
wide range of FDA-authorized tests that
are readily available, so there is little
doubt that testing itself is
technologically feasible.
This technological feasibility analysis
therefore focuses on whether testing
will continue to be readily available in
quantities sufficient to meet the
potential increase in testing demand
while this ETS is in place. Given the
wide variety of tests that can be used to
comply with this ETS and OSHA’s
review of information about the existing
manufacturing and distribution
capabilities of test manufacturers, the
agency does not anticipate feasibility
issues related to ensuring that
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employees can get access to one of the
acceptable tests within the time frames
required by the ETS.
a. Brief Overview of Testing and
Administration
COVID–19 tests that are cleared,
approved, or authorized, including in an
Emergency Use Authorization (EUA), by
the FDA to detect current infection with
the SARS–CoV–2 virus (e.g., a viral test)
satisfy the ETS. FDA-cleared, approved,
or authorized molecular diagnostic tests
and antigen tests are permitted under
the ETS when used as authorized by the
FDA and with a Clinical Laboratory
Improvement Amendments of 1988
(CLIA) certification when appropriate.
As described in the Summary and
Explanation for paragraph (g) (Section
VI.G. of this preamble), NAATs are a
type of molecular test that detect genetic
material. As of October 14, 2021, the
FDA had issued EUAs for 264 molecular
COVID–19 tests including tests
specified to be used ‘‘with certain
conditions of authorization required of
the manufacturer and authorized
laboratories’’, 81 of which are
authorized for home collection.
Additionally, the FDA has issued EUAs
for 2 OTC molecular COVID–19 test kits
available without a prescription (FDA,
October 14, 2021b).
NAATs, such as real-time reverse
transcription-polymerase chain reaction
(RT–PCR), have greater accuracy than
antigen tests. However, most FDA-
authorized NAATs need to be processed
in a laboratory certified under the
Clinical Laboratory Improvement
Amendments of 1988 (referred to as a
‘‘CLIA-certified laboratory’’) with
variable time to results (∼1–2 days).
While the NAAT test is a more reliable
test, the antigen test is faster and less
expensive.
An antigen test is an in vitro
diagnostic test used to detect active
SARS–CoV–2 infection. As of October
14, 2021, the FDA had issued 37 EUAs
for COVID–19 antigen tests, including
eight EUAs for over-the-counter (OTC)
antigen tests that can be used without a
prescription (FDA, October 14, 2021a).
Administration of an antigen test that
meets the definition of COVID–19 test
under this ETS falls into one of several
categories: OTC employee self-tests that
are observed by employers or authorized
telehealth proctors; point-of-care (POC)
or OTC tests performed by employers
with a CLIA certificate of waiver; and
other FDA cleared, approved, or
authorized antigen tests that are
analyzed in a CLIA certified laboratory
setting (FDA, October 14, 2021a). The
FDA has authorized POC tests that can
be used at a place of employment when
the facility is operating under a CLIA
certificate of waiver. A CLIA certificate
of waiver can be issued by CMS and
may, when consistent with FDA’s
authorization, allow a laboratory to run
a SARS–CoV–2 test outside a high or
moderate complexity traditional clinical
laboratory setting (CDC, September 9,
2021). In accordance with the CLIA
certificate of waiver, the laboratory or
POC testing site must use a test
authorized for that location, like an FDA
EUA POC test, and must adhere to the
authorized test instructions to avoid
human error. Certain COVID–19 antigen
diagnostic tests can be analyzed on-site
(where the person took the nasal swab)
when that facility is operating under a
CLIA certificate of waiver, while others
must be analyzed in a CLIA certified
high or moderate complexity laboratory
setting. Some COVID–19 antigen
diagnostic tests are authorized for use at
home, without the need to send a
sample to a laboratory. Antigen tests
generally return results in
approximately 15–30 minutes. The CDC
provides training materials created by
test manufacturers for POC antigen
testing and reading of results for SARS–
CoV–2 (CDC, July 8, 2021).
COVID–19 antigen diagnostic tests are
found at physician offices; urgent care
facilities; pharmacies, such as CVS or
Walgreens; school health clinics; long-
term care facilities and nursing homes;
temporary locations, such as drive-
through sites managed by local
organizations; and other locations across
the country (CDC, July 8, 2021; CVS
Health, October 2021; Walgreens,
October 8, 2021). The availability of
government-offered antigen tests varies
by state, and may be free or subsidized
and accessible without a prescription or
physician note (RiteAid, October 2021;
Walgreens, October 2021; HHS, June 11,
2021). The Department of Health and
Human Services (HHS) provides a
publicly-available list of community-
based testing locations in each state that
offer free COVID–19 testing for insured
and uninsured residents (HHS, August
17, 2021). Pharmacies and other
locations often provide antigen tests by
appointment, although some will allow
testing for walk-ins (CVS Health,
September 2021; Walgreens, October 8,
2021). COVID test kits are currently
available from several on-line retailers
(Amazon, October 12, 2021).
b. Testing Frequency
The ASU WEF survey data also
supports OSHA’s finding that the
requirement for employees who are not
fully vaccinated to be tested at least
every seven days is feasible. The ASU
WEF found that 73% of survey surveyed
employers (797 employers) had testing
policies for their workforce, and 76% of
those employers had implemented
mandatory testing requirements.
Additionally, 25% of employers with
testing polices had implemented
requirements for routine testing of a
portion of or the entire workforce, and
41% no longer require testing for fully
vaccinated employees. Of the employers
that test employees, 27% of those
perform viral testing daily and 46%
perform viral test once a week. Finally,
38% of companies exclusively
administer polymerase chain reaction
(PCR) tests (PCR tests are a type of
NAAT), 17% exclusively administer
antigen tests, and 45% administer both.
Companies administer a range of
COVID–19 tests and conduct testing at
a variety of locations (some companies
use more than one location). Forty-two
percent of companies test workers at
health testing laboratories, 35% test
onsite at work, 28% test at hospitals,
23% test at retail pharmacies, 13% test
at universities, 9% test at home to be
sent a lab for evaluation, and 5% test at
home for immediate results (ASU WEF,
September 2021).
OSHA also evaluated evidence of
employers’ current testing efforts by
reviewing existing COVID–19 practices
developed by employers, trade
associations, and other organizations.
Based on its review, OSHA concludes
that it is feasible for most covered
employees (and therefore their
employers) to be tested in compliance
with the ETS requirements for
frequency of testing.
OSHA notes that there are several
options for large employers to consider
if they want to help facilitate testing for
employees who are not vaccinated.
Delta Airlines, for example, currently
requires weekly COVID–19 testing for
all of its employees who are not
vaccinated, and the company has
engaged the Mayo Clinic Laboratories to
help design the employee testing
program, assist in administering
diagnostic and serology tests, and
analyze the results to determine broader
trends and provide recommendations to
Delta’s existing policies and procedures
(Mayo Clinic Laboratories, June 30,
2020). Delta Airlines also operates
onsite testing in cities with large
employee populations including
Atlanta, Minneapolis, and New York. It
recently extended an at-home specimen
collection option to all U.S. employees,
through which Quest Diagnostics will
send self-collection kits directly to an
employee’s doorstep upon request and
support complete laboratory
confirmation for results (Delta, August
25, 2021).
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c. Availability of COVID–19 Tests
In the spring and early summer
months of 2021, demand for tests
decreased as vaccinations began to
increase and the number of COVID–19
cases declined before the Delta surge
and some manufacturers slowed
production of COVID–19 tests.
However, the number of tests performed
daily has grown considerably over the
summer due to the Delta Variant surge
and re-openings of workplaces and
schools. In parallel with the Delta surge,
COVID–19 testing has increased from a
daily average of about 450,000 in early
July 2021 to about 1.8 million by mid-
September 2021, or roughly 12.6 million
per week (JHU, October 8, 2021). This
data does not include any self-
administered OTC tests, which will be
discussed below.
OSHA’s review of the evidence shows
that the increasing rate of production of
COVID–19 tests is more than adequate
to meet rising demand related to
compliance with the ETS testing option
before the 60-day delayed testing
compliance date (see paragraph
(m)(2)(ii)). This determination is largely
based on the number of tests with FDA
EUAs actively being produced through
the National Institutes of Health (NIH)
Rapid Acceleration of Diagnostics
(RADx) initiative described below.
According to the Johns Hopkins
University of Medicine Coronavirus
Resource Center, the total tests
administered in August 2021 was
approximately 44.4 million (or
approximately 11.1 million per week).
Id. During that same month, the total
tests produced by the NIH RADx
contracts was approximately 121
million (which would average to 30.25
million per week), resulting in a
substantial surplus of available tests
(NIBIB, September 28, 2021). As
discussed in Economic Analysis,
Section IV.B. of this preamble, Table
IV.B.8, OSHA estimates that as many as
7.2 million tests may be administered
weekly under this standard; however,
7.2 million is almost certainly an
overestimate because it does not
exclude employees who are already
required to be tested by their employers
and would continue to be tested at the
same frequency after the ETS. Even if
testing is increased by 7.2 million tests
per week because of the ETS, that would
still mean a surplus of nearly 12 million
tests per week beyond what would be
need to continue at current testing
levels with the addition of ETS-related
tests (30.25 ¥ 11.1 ¥ 7.2 = 11.95
million surplus per week).
The total number of tests
administered during June, July, and
August 2021, the period of the summer
including the Delta Variant surge and
other reasons for substantial testing
increases such as re-opening of schools,
was approximately 87 million tests, an
average of approximately 6.7 million per
week (JHU, October 8, 2021). During
that period, more than 400 million
COVID–19 tests were produced through
the NIH RADx initiative, or roughly 33
million per week. OSHA anticipates that
this surplus of tests will continue to
increase the availability of tests that can
be used to comply with the ETS.
The data from the Johns Hopkins
Coronavirus Resource Center is
collected from state and county
government sources, so it does not
include any self-administered OTC
tests. Additionally, while all states
report PCR testing, not all states report
antigen testing. Nevertheless, the data
from Johns Hopkins Coronavirus
Resource Center is the best available
evidence from which to estimate the
total number of tests administered
during a given period of time. Even
though the number of administered tests
reported through the Johns Hopkins
Coronavirus Resource Center does not
include unreported OTC tests, the NIH
RADx program data shows a large
surplus and sufficient additional
COVID–19 test capacity relative to the
number of administered tests reported.
Additionally, the NIH RADx program
will further allow for increased test
distribution through retail markets and
will address any increase in demand
due to companies that may stockpile
tests. This increased availability will
strengthen test capacity, further
enabling compliance with the ETS
testing provision (NIBIB, September 28,
2021). OSHA has determined that even
with an estimated additional 7.2 million
tests administered weekly due to the
ETS (see Economic Analysis (Section
IV.B. of this preamble)), there are
sufficient COVID–19 tests available to
allow for both employers and employees
to obtain COVID–19 tests through a
variety of retail sources (e.g., local
pharmacies, on-line purchasing as
discussed above).
Determinations of testing capacity are
aggregate measures of domestic and
global market and supply chains.
Throughout the pandemic, diagnostic
testing capacity has been stressed by the
increased demand, as some products
that are part of a global market cannot
adapt by simply increasing
manufacturing in one country (e.g.,
laboratory instruments), and other
products manufactured domestically
require capital investments to address
rising demands (e.g., extraction kits)
(CRS, February 25, 2021). As discussed
below, because of the substantial
investments made, OSHA projects that
the diagnostic testing capacity can meet
the increased demand due to this ETS.
OSHA evaluated multiple projections
of current and future testing capacity
and determined that projections related
to the NIH initiatives discussed below
are the most reliable estimates of current
and future testing capacity for its
technological feasibility assessment.
Test manufacturers receiving NIH, FDA,
and Biomedical Advanced Research and
Development Authority (BARDA) (a
component of HHS) funding as part of
these programs undergo a submission
and authorization process where their
production capacity and pipeline are
assessed and production quantities are
validated. As explained below, as of
August 2021, the NIH data indicates
testing capacity stands at about 30
million tests per week, and capacity
continues to grow (NIBIB, September
28, 2021). OSHA notes that this number
underestimates the total number of tests
available each week, as it only includes
companies that have received funding
for tests and testing supplies through
the NIH initiatives described below.
The NIH has identified constraints on
testing capacity as an area of focus and
investment since the beginning of the
COVID–19 pandemic, and OSHA
examined potential constraints on
testing capacity as part of its feasibility
analysis. As described below, massive
investments in testing capabilities,
particularly in underserved areas, have
largely mitigated issues with the
availability of COVID–19 tests. Further,
testing capacity continues to grow as
new tests are developed and brought to
market and manufacturers can ramp up
supply to meet any future testing
demands if need be.
The FDA has authorized more than
320 tests and collection kits that
diagnose current infection with the
SARS–CoV–2 virus and may be
acceptable under the ETS (FDA, October
1, 2021). Among other criteria, the
standard allows for the use of tests with
specimens that are processed by a CLIA
certified laboratory (including home or
on-site collected specimens which are
processed either individually or as
pooled specimens), proctored over-the-
counter tests, point of care tests, and
tests where specimen collection and
processing is either done or observed by
an employer. As explained above, many
employers across various industry
sectors have already implemented
policies for onsite testing. The use of
FDA-authorized POC tests by these
employers would be compliant with the
testing provision of the ETS if the entity
administering the test holds a CLIA
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certificate as required by the EUA.
COVID–19 OTC tests that are both self-
administered and self-read by
employees do not satisfy the testing
requirement unless observed by the
employer or an authorized telehealth
proctor. In the event that the employer
is merely observing the employee
conduct a test, a CLIA certificate would
not be needed.
There have been extensive
investments, including by the federal
government, to help ensure that COVID–
19 tests are widely available. Section
2401 of the American Rescue Plan
appropriated $47,800,000 to the
Secretary of the HHS, to remain
available until expended, to carry out
activities to detect, diagnose, trace, and
monitor SARS–CoV–2 and COVID–19
infections and related strategies to
mitigate the spread of COVID–19. Funds
were made available to implement a
national testing strategy; provide
technical assistance, guidance, support,
and awards grants or cooperative
agreements to State, local, and territorial
public health departments; and support
the development, manufacturing,
procurement, distribution, and
administration of tests to detect or
diagnose SARS–CoV–2 and COVID–19;
and establish federal, state, local and
territorial testing capabilities.
On April 29, 2020, the NIH
established the RADx initiative with a
$1.5 billion investment. The RADx
initiative has used this funding to speed
development of rapid and widely-
accessible COVID–19 testing (NIH, April
29, 2020). On October 6, 2020, the NIH
and BARDA established the RADx
Technology (RADx-Tech) and RADx
Advanced Technology Platforms (RADx-
ATP) programs to speed innovation in
the development, commercialization,
and implementation of technologies for
COVID–19 testing specifically for late-
stage scale-up projects. Through the
RADx Tech and RADx-ATP programs,
the NIH and BARDA have awarded a
total of $476.4 million in manufacturing
expansion contracts supporting a
combined portfolio of 22 companies in
the U.S. (NIH, October 6, 2020).
These programs have significantly
increased testing capacity throughout
the country. Since being established,
RADx has worked closely with the FDA,
the CDC, and BARDA to move more
advanced diagnostic technologies
swiftly through the development
pipeline toward commercialization and
broad availability. On April 28, 2021,
the Institute of Electrical and Electronic
Engineers (IEEE) dedicated a special
issue in the Journal of Engineering in
Medicine and Biology exploring the
innovative structure and operation of
the RADx Tech program and determined
that the initiatives had succeeded in
dramatically increasing COVID–19
testing capacity in the United States.
The IEEE report found that the RADx
Tech/ATP programs, in conjunction
with BARDA and the FDA, had
streamlined and bolstered the national
COVID–19 testing capacity. At the time
of the report, the RADx Tech/ATP
programs had increased the number of
testing makers to 150 companies that, as
a result of the NIH/BARDA investments,
had the capacity to produce up to 1.9
million tests per day (IEEE, April 28,
2021).
The NIH RADx-TECH/ATP initiative
entered its second phase on September
28, 2021, and at that time the supported
companies had collectively produced
over 500 million tests, received 27 FDA
authorizations, and developed the first
OTC COVID–19 test for use at home.
These September 2021 investments are
supporting late stage development of
innovative point-of-care and home-
based tests, as well as improved clinical
laboratory tests that will increase the
capacity of testing in the U.S. A full list
of active contracts and supported U.S.
COVID–19 testing manufacturers can be
found on the NIH RADx-TECH/ATP
programs: Phase 2 awards (NIBIB,
October 14, 2021).
The following example shows the NIH
RADx EUA pipeline process. On May 9,
2020, the FDA authorized the first EUA
for a COVID–19 antigen test, a new
category of tests for use in the ongoing
pandemic. Quidel was awarded a
contract under the NIH RADx TECH/
ATP phase 1 initiative for the Sofia 2
SARS Antigen FIA for use in high and
moderate complexity laboratories
certified by CLIA, as well as for point-
of-care testing by facilities operating
under a CLIA certificate of waiver (FDA,
May 9, 2020). On July 31, 2020, Quidel
announced that it had received a
contract for $71 million under the NIH
RADx TECH/ATP program, phase 1, to
accelerate the expansion of its
manufacturing capacity for production
of the SARS–CoV–2 rapid antigen test
and quickly exceeded that capacity
(Quidel Corp., July 31, 2020). On March
31, 2021, the FDA then authorized a
second EUA from Quidel under contract
with the NIH RADx initiative for the
QuickVue At-Home OTC COVID–19
Test, another antigen test where certain
individuals can rapidly collect and test
their sample at home, without needing
to send a sample to a CLIA certifed
laboratory for analysis (FDA, March 31,
2021). Furthermore, based on the
success of the Quidel for the Sofia 2
SARS Antigen FIA increasing
production capacity, the NIH granted
another $70 million contract for
manufacturing Capacity Scale-Up for
Sofia SARS Antigen and Sofia Influenza
A+B/SARS FIAs on June 11, 2021 (FDA,
June 11, 2021).
The RADx-TECH/ATP initiative
maintains a dashboard of manufacturer
testing data from supported U.S. firms.
OSHA reviewed the data available on
the dashboard as part of its
determination of feasibility. In August
2021, the data showed that U.S.
manufacturers supported by the NIH
RADx-TECH/ATP were producing
approximately 30 million tests per week
(NIBIB, September 28, 2021).
While consumers in some parts of the
country have encountered difficulty
obtaining rapid at-home tests, on
October 4, 2021, the FDA granted EUA
for the ACON Laboratories Flowflex
COVID–19 Home Test, which is
anticipated to double rapid at-home
testing capacity in the United States
within weeks (and well before
compliance dates for testing required by
this ETS) (FDA, October 4, 2021). By the
end of the 2021 (ahead of the paragraph
(g) compliance date), the manufacturer
plans to produce more than 100 million
tests per month and plans to produce
more than 200 million tests per month
by February 2022 (FDA, October 4,
2021). On October 6, 2021, the
Administration announced a plan to
buy $1 billion worth of rapid at-home
COVID–19 tests; this purchase, coupled
with the October 4 authorization of the
Flowflex COVID–19 test, is expected to
increase the number of available at-
home COVID–19 tests to 200 million per
month by December 2021 (Washington
Post, October 6, 2021).
These investments have had a
pronounced impact on the availability
of testing and employers’ use of testing
in the workplace. ASU’s recent report,
How Work has Changed: The Lasting
Impact of COVID–19 on the Workplace,
ascribed the jump in the percentage of
employers that test their employees
from 17% in the fall of 2020 to 70% in
the fall of 2021 in large part to the
increased availability of testing. In
particular, the report noted that by the
spring of 2021, ‘‘it became relatively
easy to acquire tests and hire testing
service providers. There are more labs
and companies with EUA’s and most
have enough capacity that there are few
shortages.’’ (ASU WEF, September
2021).
Moreover, to ensure a broad,
sustained capacity for COVID–19 test
production, multiple COVID–19 test
manufacturers have been mobilized by
authority of the Defense Production Act.
Under the Administration’s plan to
increase COVID–19 testing, the federal
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government will directly purchase and
distribute 280 million- rapid point-of-
care and over-the-counter at-home
COVID–19 tests, sending 25 million free
at-home rapid tests to community health
centers and food banks. These actions
will provide tests for use by
communities to build adequate
stockpiles, as well as the sustained
production to be able to scale up
production as needed in the future.
Additionally, to ensure convenient
access to free testing, 10,000 pharmacies
will be added to the Department of
Health and Human Services free testing
program.
In response to rising demands for
testing, U.S. manufacturers have
increased production of COVID–19 test
kit, reagents, and supplies. Advanced
Medical Technology Association
(AdvaMed), a trade group for testing
manufacturers, reported that its
members are ramping up production of
rapid point-of-care test supplies to meet
demand and that laboratory-based
testing capacity for test confirmation is
strong. AdvaMed has created a national
COVID–19 Diagnostic Supply Registry
of COVID–19 test manufacturers that
support state and federal governments
in their pandemic responses. Registry
participants are thirteen leading
diagnostic manufacturers whose tests
together comprise approximately 75–
80% of the COVID–19 in vitro
diagnostic devices (IVD) on the market
in the U.S. While these manufacturers
produce a majority of molecular
COVID–19 tests, they do not produce a
majority of the total COVID–19 tests
manufactured. These COVID–19 test
manufacturers collectively shipped
approximately 3.8 million tests in July
2021, 8.2 million tests in August 2021,
and 9.4 million molecular tests for the
week ending September 4th, 2021
(AdvaMed, September 10, 2021). While
these figures are not representative of
the total weekly testing capacity in the
U.S., this data demonstrates that testing
capacity has grown significantly over
the past few months and reflects the
success manufacturers have had in
ramping up production of tests.
While current test availability is
sufficient to meet the increased testing
demands due to the ETS, OSHA is also
confident that the RADx-TECH/ATP
initiatives will continue to spur testing
capacity and growth. The RADx-TECH/
ATP initiatives have focused on moving
test makers’ products through the late
stage pipeline and securing FDA
authorization for entry into the market.
So far, there have been 27 such
authorizations. As of September 2021,
there were 824 eligible late-stage scale
up proposals from various test makers
up for review for NIH/BARDA funding.
Furthermore, 517 of these submissions
are for the authorization and production
of multiple types of COVID–19 tests
including one or more of the following:
Blood, sputum, nasal swab, oral swab,
fecal, saliva, or other types. OSHA
considers this to be further support for
its determination that testing capacity
will continue to grow and that increased
COVID–19 testing supplies are on the
horizon (NIBIB, September 28, 2021).
Based on data from the Johns Hopkins
Coronavirus Resource Center, which
examined publicly-available data from
multiple sources, approximately 12.4
million tests were conducted during the
week of August 26–September 2, 2021.
As noted earlier, in the economic
analysis of this ETS, OSHA projects
testing rates to increase by
approximately 7.2 million tests per
week starting 60 days after publication
of the ETS. As described above, many
employers are currently testing their
workforce. This 7.2 million is almost
certainly an overestimate because it
does not exclude employees who are
already required to be tested by their
employers and would continue to be
tested at the same frequency after the
ETS. The data reviewed by OSHA on
the RADx-TECH/ATP Dashboard shows
that the manufacturers supported by the
initiative are producing approximately
30 million tests per week, and capacity
continues to grow. As explained above,
it is expected that roughly 50 million at-
home COVID–19 tests will be available
each week by December 2021. OSHA
therefore finds that there are (and will
continue to be) sufficient COVID–19
tests available to meet the anticipated
demand related to compliance with
paragraph (g) by the 60-day delayed
compliance date.
d. Availability of COVID–19 Test
Supplies
OSHA has also analyzed the
availability of COVID–19 test supplies
for use by COVID–19 test kit
manufacturers, diagnostic laboratories,
and determined that there are sufficient
supplies to allow compliance with the
ETS testing option. The COVID–19
pandemic and recent Delta Variant
surge have caused some disruptions in
the availability of testing supplies such
as swabs, viral transport medium, RNA
extraction kits, serology consumables,
diagnostic reagents, plastic
consumables, and diagnostic
instruments. The COVID–19 testing
supply market is driven by the need to
rapidly screen large segments of the
population and deliver test results. The
data presented throughout this
assessment has shown demand for
laboratory COVID–19 tests is rising
across the country.
Testing for COVID–19 involves many
different components that are
manufactured, transported, and used
independently (e.g., bulk solvents,
extracting reagents, packaging) or semi-
independently (e.g., test kits). Most of
the supplies used in COVID–19 testing
are disposable, requiring a constant
sustained capacity for new supplies.
Some distribution channels move
supplies directly to medical and
laboratory end-users and others move
supplies through distributors. In either
case, the combination of increased
testing demand and the established
supply chains indicate that testing kits
will be available in sufficient quantities
throughout the country, including in
rural areas where large employers may
be located.
There have been substantial
investments from federal and state
programs and private industry to
stimulate the production and
distribution of testing supplies to bolster
testing capacity across the country.
Many products, such as swabs and
reagents for RNA extraction kits,
exhibited rising demand and, at some
point during the pandemic, were subject
to shortages that threatened continued
testing capacity. For example, there was
only one domestic manufacturer of
medical grade flocked swabs, Puritan
Medical Products Company of Guilford,
Maine, and the company’s pre-
pandemic capacity was insufficient to
meet demand of increased testing in the
early period of the COVID–19 pandemic
(Puritan Products, April 20, 2020). On
July 29, 2020, the Department of
Defense (DOD), in coordination with the
Department of Health and Human
Services, awarded $51.15 million to
Puritan to expand industrial production
capacity of flock tip testing swabs (DOD,
July 31, 2020). On March 26, 2021,
Puritan was awarded another $146.77
million to increase the company’s total
production capacity to 250 million foam
tip swabs per month at its Tennessee
facility by February 2022 (DOD, March
29, 2021).
Other private sector companies were
mobilized to change the products they
manufactured to accelerate production
of COVID–19 test components, such as
swabs, reagents, and solvents for RNA
extraction kits. For example,
Microbrush, a U.S.-based manufacturer
of sterile applicators for the dental
industry, began production of a
nasopharyngeal test swab to meet the
growing demand for COVID–19 testing
requirements in July 2020. The
Microbrush test swabs are sterilized and
individually packaged in a medical-
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grade pouch intended for
nasopharyngeal sample collection such
as in dental procedures and also
COVID–19 testing (Microbrush, July 1,
2020).
RNA extraction kits are used by the
majority of NAAT protocols. These kits
are sets of consumable plastic laboratory
materials (small centrifuge tubes, filters,
and collection vials) and chemical
reagents (solutions for breaking the
virus apart and purification) assembled
by a manufacturer. Each kit has enough
materials to process several dozen
samples. The use of RNA extraction kits
is not exclusive to COVID–19 testing,
meaning that a market existed pre-
COVID–19, and manufacturers were
able to adapt to fluctuations in demand
spurred by the pandemic.
There are multiple companies with
facilities in the United States that
produce RNA extraction kits for the
domestic market that have been
awarded federal grants to increase the
supply of COVID–19 test kits and
reagent supplies. For example, in
December 2020, the DOD and HHS
identified several key reagents with the
potential for supply chain bottlenecks
and awarded a $4.8 million Indefinite
Delivery/Indefinite Quantity contract to
Anatrace Products, LLC to support
increased production of key reagents for
sample processing; Polyadenylic Acid
(Poly A), Guanidinium Thiocyanate
(GTC), and Proteinase K (Pro K) to
process samples (DOD, December 21,
2020). Additionally, QIAGEN (based in
Germany with U.S. manufacturing in
Germantown, Maryland) produces
extraction kits for authorized COVID–19
tests and has responded to the
pandemic by scaling their production to
around the clock production to
strengthen testing kit capacity (Qiagen,
October 2, 2021). On August 23, 2021,
DOD, on behalf of and in coordination
with HHS, awarded a $600,000 contract
to QIAGEN to expand manufacturing
capacity of enzymatic reagents and
reagent kits used in COVID–19
molecular diagnostic tests, thereby
allowing QIAGEN to increase its
monthly production of reagent kits by
7,000 and enzymes by 5,100 milligrams
by the end of February 2022 to support
domestic laboratory testing for COVID–
19 (DOD, August 23, 2021).
Additionally, manufacturers of raw
materials and solvents for COVID–19
test kits have implemented strategies to
strengthen their portions of the COVID–
19 test supply chain. Millipore Sigma, a
large producer of solvents and raw
materials for tests, has created a global
task force to actively evaluate the
overall supply chain of products and
key raw material suppliers to mitigate
any potential disruption of COVID–19
testing capacity (Millipore Sigma,
October 2021). In light of the foregoing,
OSHA believes that there is sufficient—
and increasing—availability of COVID–
19 testing supplies to enable compliance
with the ETS testing option.
e. Sufficiency of Laboratory Capacity
As noted above, a wide range of tests
are acceptable under the ETS, including
those that can be observed by employers
without laboratory processing.
Moreover, there has been rapid growth
in the availability of OTC tests that do
not require laboratory processing.
Authorized OTC tests self-administered
by employees and proctored by the
employer do not require a CLIA
certificate of waiver.
The Association of Public Health
Laboratories (APHL) has conducted
weekly surveys of its membership to
monitor their current and projected
capability and capacity to test for
COVID–19. Data from this survey is
used to inform HHS, FEMA, CDC, and
other federal partners to support public
health laboratory supply and reagent
needs. OSHA reviewed the weekly
COVID–19 survey results through the
APHL COVID–19 Lab Testing Capacity
and Capability Data Dashboard. The
data comes from voluntary participation
in the weekly surveys collected from
approximately 100 state, local and
territorial public health laboratories
(PHLs) and reported to the CDC. The
APHL weekly survey data supports
OSHA’s feasibility determination and
demonstrates that COVID–19 testing
demand will be met. For example, from
August 15, 2021 to September 12, 2021,
the APHL weekly survey data found that
96–100% of PHLs are meeting their
current testing demand since the Delta
Variant surge began (APHL, September
27, 2021).
Laboratory capacity for processing
and confirmation of at-home COVID–19
rapid tests provided by manufacturer
retailers such as Walmart has also
increased. Laboratory and diagnostic
service providers have implemented
parallel strategies to strengthen
laboratory capacity for confirmation of
at-home COVID–19 rapid tests available
on the market for employers and
employees to utilize. For example,
Quest Diagnostics, which is the
laboratory processing the samples and
delivering results to those tested at
Walmart’s drive-through and curbside
testing sites, has scaled up laboratory
testing capacity and rapid antigen test
inventory should demand increase
(Walmart, July 9, 2021). Quest
Diagnostics has added COVID–19
testing platforms in laboratories in
regions where demand is comparatively
high and has implemented an online
consumer-initiated test service for
individuals and small businesses to
request COVID–19 testing. In August
2021, Quest Diagnostics began to offer
clinician-guided rapid COVID–19
antigen testing to employers through a
guided telehealth visit using a self-
administered, nasal swab antigen test
that provides results in 15 minutes that
is then shipped to a Quest Diagnostics
lab for confirmation (Quest Diagnostics,
September 28, 2021).
Based on the evidence reviewed,
OSHA has determined that there is
adequate laboratory capacity to enable
compliance with the ETS testing option.
f. Access to Testing in Underserved
Communities
Individuals in underserved
communities (including Black, Latino,
and Indigenous and Native American
persons, Asian Americans and Pacific
Islanders and other persons of color;
members of religious minorities;
lesbian, gay, bisexual, transgender, and
queer persons; persons with disabilities;
persons who live in rural areas; and
persons otherwise adversely affected by
persistent poverty or inequality) are
disproportionately burdened by the
COVID–19 pandemic as many
individuals in these communities are
essential workers who cannot work from
home, increasing their risk of being
exposed to the virus. Access to COVID–
19 testing in these communities has
been identified as contributing factor to
COVID–19 related health disparities in
these communities. For example, the
NSC June 2021 survey found that the
most common barrier to testing for rural
employers and workers is access to
vaccination and testing sites (NSC,
September 2021).
Several federal efforts have recently
been implemented to strengthen testing
capabilities in underserved
communities. The NIH has invested
heavily to improve COVID–19 testing in
underserved communities throughout
the COVID–19 pandemic. On September
30, 2020, the NIH received nearly $234
million to improve COVID–19 testing
for underserved and vulnerable
populations that have been
disproportionately affected by this
pandemic and launched the RADx
Underserved Populations (RADx-UP)
program (NIH, September 30, 2020).
The RADx-UP program has primary
components supported by these NIH
grants to increase availability,
accessibility, and acceptance of testing
among underserved and vulnerable
populations. The RADx-UP program
also provides overarching support and
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guidance on administrative operations
and logistics, facilitating effective use of
COVID–19 testing technologies,
supporting community and health
system engagement, and providing
overall infrastructure for data collection,
integration, and sharing from a
coordination and data collection center
(NIH, September 30, 2021). Through the
RADx-UP program, the NIH has
continued to support the needs of
underserved populations and is
currently funding 70 community-based
projects across the country (NIH,
September 30, 2021).
The CDC has also focused its efforts
to improve COVID–19 testing in
underserved communities throughout
the COVID–19 pandemic. For example,
on September 20, 2021, Maine Health,
the largest health care organization in
Maine and also serving northern New
Hampshire, was awarded nearly $1
million for COVID–19 testing in higher
risk communities (Maine Health,
September 20, 2021). In March 2021, the
CDC implemented a plan to invest $2.25
billion over two years to address
COVID–19 related health disparities and
advance health equity among
populations that are at high-risk and
underserved, including racial and
ethnic minority groups and people
living in rural areas. Since that time, the
CDC has awarded grants to public
health departments to improve testing
capabilities; improve data collection
and reporting; and build, leverage, and
expand infrastructure support for testing
(CDC, March 17, 2021). On September
30, 2021, the CDC awarded an $8.1
million grant to the Arizona Center for
Rural Health (ACRH) to address COVID–
19 disparities across Arizona by
improving the delivery of COVID–19
testing to rural and underserved
communities (ASU CRH, September 30,
2021). A number of other federal and
state government agencies have been
expanding support for COVID–19
testing in underserved communities as
well. On June 11, 2021, HHS through
the Health Resources and Services
Administration (HRSA) provided $424.7
million in American Rescue Plan
funding to over 4,200 Rural Health
Clinics (RHCs) for COVID–19 testing
(HHS, June 11, 2021).
Private industry has also mobilized
considerably to increase access and
testing capacity in rural and other
underserved communities. The NSC
June 2021 survey found that a common
barrier to employers and employees in
rural and other underserved
communities is transportation and
access to vaccination and testing sites
(NSC, September 2021). In its final
report, the NSC recommended
employers in these communities host
on-site vaccinations to increase worker
access. Applications for mobile
vaccination are available on most local
and state health department websites
(NSC, September 2021; ASU WEF,
September 2021).
CVS has collaborated with several
organizations, including the National
Medical Association, to increase access
to testing in underserved communities
and has developed mobile solutions that
allow health care professionals to bring
testing capabilities to businesses in
these communities as they re-open (CVS
Health, September 2021). Walgreens has
implemented efforts to increase access
in underserved communities such as
rural and/or lower socioeconomic
communities as well, with now more
than half of Walgreens testing sites
currently located in areas the CDC has
identified as socially vulnerable and
underserved (Walgreens, October 2021).
Because of these investments, OSHA
concludes that employers and their
employees in underserved communities,
including those in rural areas, will have
sufficient access to COVID–19 tests and
will be able to comply with the ETS’s
testing requirements for employees who
are not fully vaccinated.
V. Management of Confidential Medical
Records, Including Employee COVID–19
Vaccination and Testing Records
The ETS requires employers to
maintain a record of each employee’s
vaccination status. Employers must also
maintain a record of each test result
provided by each employee. These
records must be maintained as
confidential medical records and must
not be disclosed except as required or
authorized by this ETS or other federal
law. The records are not subject to the
retention requirements of 29 CFR
1910.1020(d)(1)(i) but must be
maintained and preserved while the
ETS is in effect.
Other OSHA rules have a similar
requirement to maintain employee
medical records, which could include
vaccination records. See, e.g.,
Bloodborne Pathogens (29 CFR
1910.1030), Respiratory Protection (29
CFR 1910.134), Respirable Crystalline
Silica (29 CFR 1910.1053), Beryllium
(29 CFR 1910.1024), Lead (29 CFR
1910.1025), and OSHA’s requirements
for employee access to medical and
exposure records (29 CFR 1910.1020).
OSHA is not aware of any potential
technological feasibility issues related to
recordkeeping.
The requirement under this ETS to
maintain records of employees’ COVID–
19 vaccination status and COVID–19
test results is similar to requirements in
the aforementioned OSHA standards,
and OSHA therefore concludes that
compliance is feasible. Employers
subject to the ETS will be able to
comply with the provisions in the ETS
using straightforward recordkeeping
systems that are already widely used by
large employers as part of their usual
and customary business practices.
OSHA concludes that it is feasible for
such employers to comply with the
requirements in the ETS for maintaining
records related to COVID–19
vaccination status and COVID–19 test
results.
VI. Other Provisions
There are no technological feasibility
barriers related to compliance with
other requirements in the ETS (e.g., face
coverings, employee notification). As
explained above, many of the employer
plans and best practice documents
reviewed by OSHA indicate that
employers have implemented the
measures in these provisions across
industry sectors. OSHA highlights two
of the ETS’s other requirements below,
which are explored in more depth in
other sections of this preamble.
• Face Coverings. Paragraph (i) of the
ETS requires the employer to ensure
that all employees who are not fully
vaccinated wear a face covering when
indoors and when occupying a vehicle
with another person for work purposes,
except: (i) When an employee is alone
in a room with floor to ceiling walls and
a closed door; (ii) for a limited time
while the employee is eating or drinking
at the workplace or for identification
purposes in compliance with safety and
security requirements; (iii) when
employees are wearing respirators or
face masks; or (iv) where the employer
can show that the use of face coverings
is infeasible or creates a greater hazard.
The definition of face covering allows
various different types of masks,
including clear face coverings or cloth
face coverings with a clear plastic panel
which may be used to facilitate
communication with people who are
deaf or hard-of-hearing or others who
need to see a speaker’s mouth or facial
expressions to understand speech or
sign language respectively. The types of
face coverings permitted under this ETS
are widely used and readily available.
The results of the ASU WEF June 2021
survey found that 30% of employers
required face coverings for unvaccinated
employees, which demonstrates that
this provision of the ETS is currently
being implemented by a substantial
number of employers and is ‘‘capable of
being done.’’ (ASU WEF, September
2021). OSHA identifies no technological
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feasibility issues with this provision of
the ETS.
• Notification. Paragraph (h) of the
ETS contains COVID–19 notification
requirements for both the employer and
the employee. Under this provision, the
employer must require each employee
to promptly notify the employer if they
receive a positive COVID–19 test or are
diagnosed with COVID–19 by a licensed
healthcare provider and must
immediately remove any employee from
the workplace who receives a positive
COVID–19 test or is diagnosed with
COVID–19 by a licensed healthcare
provider. OSHA identifies no
technological feasibility issues in
connection with the ETS’s notification
requirements. It is the employer’s
responsibility to ensure that appropriate
instructions and procedures are in place
so that designated representatives of the
employer (e.g., managers, supervisors)
and employees conform to the rule’s
requirements.
VII. Conclusion
OSHA has determined that complying
with this ETS is technologically feasible
for typical firms covered by this
standard, at least most of the time (see
Public Citizen v. OSHA, 557 F.3d 165
(3d Cir. 2009); Lead I, 647 F.2d at 1272;
Lead II, 939 F.2d at 990). OSHA
reviewed extensive evidence across
industries and did not identify any
industry-specific compliance barriers.
Evidence in the record that shows that
the written workplace COVID–19
vaccination policy requiring each
employee to be fully vaccinated against
COVID–19 unless they establish and
implement a written policy that permits
an employee to choose to be tested for
COVID–19 at least every seven days and
wear a face covering is feasible. In fact,
such policies have already been
implemented by hundreds of large
companies across industry sectors.
OSHA has also determined that there
are sufficient COVID–19 tests available
and adequate laboratory capacity to
meet the anticipated increased testing
demand related to compliance with the
ETS testing option.
Additionally, the ETS’s requirements
to determine employee vaccination
status, support employee vaccination by
providing time off for vaccination and
time off for recovery, and maintain
records of employee COVID–19
vaccination status and COVID–19 test
results are also technologically feasible.
As discussed above, that many
employers and organizations have
already implemented such requirements
demonstrates that they are ‘‘capable of
being done.’’ Moreover, the
recordkeeping requirements in this ETS
largely mirror the requirements for the
collection and maintenance of similar
employee medical records in OSHA’s
Bloodborne Pathogens standard (29 CFR
1910.1030) and the Respiratory
Protection standard (29 CFR 1910.134).
The ETS provides a flexible compliance
option for employers to tailor their
procedures and practices to the needs of
their workplace. OSHA finds that
employers in typical firms in all
industry sectors can comply with the
requirements of the ETS, and
compliance with the ETS is therefore
technologically feasible.
References
Advanced Medical Technology Association
(AdvaMed). (2021, September 10).
ADVAMED COVID–19 Diagnostic
Supply Registry. https://
www.advamed.org/wp-content/uploads/
2021/09/AdvaMed-COVID-Testing-
Supply-Registry-weekly-report-
091021.pdf (AdvaMed, September 10,
2021)
Amazon.com (Amazon). (2021, October 12).
Amazon.com product search results:
FDA EUA covid-19 tests. https://
www.amazon.com/
s?k=FDA+EUA+covid-19+tests&ref=nb_
sb_noss_2. (Amazon, October 12, 2021)
Arizona State University College of Health
Solutions (ASU). (2021, October 5).
COVID–19 Diagnostic Commons. https://
chs.asu.edu/diagnostics-commons.
(ASU, October 5, 2021)
Arizona State University (ASU) and the
World Economic Forum (WEF). (2021,
September). How work has changed: The
Lasting Impact of COVID–19 on the
Workplace. https://issuu.com/
asuhealthsolutions/docs/asu_workplace_
commons_sept2021_
singles?fr=sNjBiNDE5NTg1NjM. (ASU
WEF, September 2021)
Association of Public Health Laboratories
(APHL). (2021, September 27). Lab
Testing Capacity and Capability Data
Dashboard. https://www.aphl.org/
programs/preparedness/Crisis-
Management/COVID-19-Response/
Pages/COVID-19-Dashboard.aspx.
(APHL, September 27, 2021)
Becker’s Hospital Review. (2021, October 11).
Hospitals, health systems mandating
vaccines for workers. https://
www.beckershospitalreview.com/
workforce/hospitals-health-systems-
mandating-vaccines-for-
workersjune17.html. (Becker’s Hospital
Review, October 11, 2021)
Capital One. (2021, August 11). Capital
One Announces Modifications to
Workplace Return. https://
www.capitalone.com/about/newsroom/
return-to-office-update/. (Capital One,
August 11, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, March 17). CDC
Announces $2.25 Billion to Address
COVID–19 Health Disparities in
Communities that are at High-Risk and
Underserved. https://www.cdc.gov/
media/releases/2021/p0317-COVID-19-
Health-Disparities.html. (CDC, March 17,
2021)
Centers for Disease Control and Prevention
(CDC). (2021, July 8). Guidance for
SARS-CoV–2 Point-of-Care and Rapid
Testing. https://www.cdc.gov/
coronavirus/2019-ncov/lab/point-of-
care-testing.html. (CDC, July 8, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, September 9). Interim
Guidance for Antigen Testing for SARS-
CoV–2. https://www.cdc.gov/
coronavirus/2019-ncov/lab/resources/
antigen-tests-guidelines.html. (CDC,
September 9, 2021)
Colorado Department of Public Health and
Environment (CDPHE). (2021, September
17). Vaccine laws and regulations.
https://covid19.colorado.gov/vaccine-
laws-regulations. (CDPHE, September 17,
2021)
Congressional Research Service (CRS). (2021,
February 25). COVID–19 Testing Supply
Chain. https://crsreports.congress.gov/
product/pdf/IF/IF11774. (CRS, February
25, 2021)
CVS Health. (2021, August 23). CVS Health
will require COVID–19 vaccinations for
clinical and corporate employees.
https://cvshealth.com/news-and-
insights/statements/cvs-health-will-
require-covid-19-vaccinations-for-
clinical-and-corporate-employees. (CVS
Health, August 23, 2021)
CVS Health. (2021, September). COVID–19:
Testing information. https://
cvshealth.com/covid-19/testing-
information. (CVS Health, September
2021)
Delta Airlines. (2021, August 25). Bastian
memo to employees outlines COVID
vaccine updates. https://news.delta.com/
bastian-memo-employees-outlines-covid-
vaccine-updates. (Delta, August 25,
2021)
Fifty/50 Group. (2021, May 18). Employee
Vaccination Requirement Policy. https://
www.thefifty50group.com/covidvaccines.
(Fifty/50 Group, May 18, 2021)
Food and Drug Administration (FDA). (2020,
May 9). Coronavirus (COVID–19)
Update: FDA Authorizes First Antigen
Test to Help in the Rapid Detection of
the Virus that Causes COVID–19 in
Patients. https://www.fda.gov/news-
events/press-announcements/
coronavirus-covid-19-update-fda-
authorizes-first-antigen-test-help-rapid-
detection-virus-causes. (FDA, May 9,
2020)
Food and Drug Administration (FDA). (2021,
March 31). Emergency Use Authorization
QuickVue At-Home OTC COVID–19
Test. https://www.fda.gov/media/
147247/download. (FDA, March 31,
2021)
Food and Drug Administration (FDA). (2021,
June 11). Emergency Use Authorization
Sofia SARS Antigen FIA OTC COVID–19
Test. https://www.fda.gov/media/
137886/download. (FDA, June 11, 2021)
Food and Drug Administration (FDA). (2021,
September 10). COVID–19 Tests and
Collection Kits Authorized by the FDA:
Infographic. https://www.fda.gov/
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medical-devices/coronavirus-covid-19-
and-medical-devices/covid-19-tests-and-
collection-kits-authorized-fda-
infographic. (FDA, September 10, 2021)
Food and Drug Administration (FDA). (2021,
September 22). Coronavirus Disease 2019
Testing Basics. https://www.fda.gov/
consumers/consumer-updates/
coronavirus-disease-2019-testing-basics.
(FDA, September 22, 2021)
Food and Drug Administration (FDA). (2021,
October 1). Coronavirus (COVID–19)
Update: October 1, 2021. https://
www.fda.gov/news-events/press-
announcements/coronavirus-covid-19-
update-october-1-2021. (FDA, October 1,
2021)
Food and Drug Administration (FDA). (2021,
October 4). Coronavirus (COVID–19)
Update: FDA Authorizes Additional OTC
Home Test to Increase Access to Rapid
Testing for Consumers. https://
www.fda.gov/news-events/press-
announcements/coronavirus-covid-19-
update-fda-authorizes-additional-otc-
home-test-increase-access-rapid-testing.
(FDA, October 4, 2021)
Food and Drug Administration (FDA).
(2021a, October 14). In Vitro Diagnostics
EUAs—Antigen Diagnostic Tests for
SARS-CoV–2. https://www.fda.gov/
medical-devices/coronavirus-disease-
2019-covid-19-emergency-use-
authorizations-medical-devices/in-vitro-
diagnostics-euas-antigen-diagnostic-
tests-sars-cov-2. (FDA, October 14,
2021a)
Food and Drug Administration (FDA).
(2021b, October 14). In Vitro Diagnostics
EUAs—Molecular Diagnostic Tests for
SARS-CoV–2. https://www.fda.gov/
medical-devices/coronavirus-disease-
2019-covid-19-emergency-use-
authorizations-medical-devices/in-vitro-
diagnostics-euas-molecular-diagnostic-
tests-sars-cov-2. (FDA, October 14,
2021b)
Fulton County, Georgia. (2021, September 3).
Fulton Commissioners Approve
Employee Vaccine Protocols. https://
www.fultoncountyga.gov/news/2021/09/
03/fulton-commissioners-approve-
employee-vaccine-protocols. (Fulton
County Government, September 3, 2021)
Genesis Health Care. (2021, September 29).
Coronavirus Updates. https://
www.genesishcc.com/coronavirus-
updates. (Genesis Health Care,
September 29, 2021)
Health Action Alliance (HAA). (2021,
October 10). COVID–19 Vaccines:
Employers & Requirements. A list of
companies requiring vaccinations for all
or part of their workforce or customers.
https://www.healthaction.org/resources/
vaccines/covid-19-vaccines-employer-
requirements-health-action-alliance.
(HAA, October 10, 2021)
Health Action Alliance (HAA) and the
National Safety Council (NSC). (2021,
September 17). COVID–19 Employer
Policies: A Decision Tool for Business
Leaders. https://www.healthaction.org/
reopening-questions#Q. (HAA and NSC,
September 17, 2021)
Institutes of Electrical and Electronics
Engineers. (IEEE). (2021, April 28).
RADxSM Tech: A New Paradigm for
MedTech Development Overview of This
Special Section. https://
ieeexplore.ieee.org/document/9418526.
(IEEE, April 28, 2021)
International Union of Painters and Allied
Trades (IUPAT). (2021, May 10). IUPAT
Supports Vaccine Mandates. https://
www.iupat.org/press-room/vaccine-
policy/. (IUPAT, May 10, 2021)
Johns Hopkins University. (2021, October 8).
Coronavirus Resource Center: Testing
Hub. https://coronavirus.jhu.edu/testing/
individual-states. (JHU, October 8, 2021)
Kaiser Permanente. (2021, August 2).
Protecting health and safety through
vaccination. https://
about.kaiserpermanente.org/our-story/
news/announcements/protecting-health-
and-safety-through-vaccination. (Kaiser
Permanente, August 2, 2021)
MaineHealth. (2021, September 20).
MaineHealth awarded nearly $1M by
National Institutes of Health to study
COVID–19 testing in higher risk
communities. https://
www.mainehealth.org/News/2021/09/
MaineHealth-awarded-nearly-1M-by-
NIH-to-study-COVID19-testing. (Maine
Health, September 20, 2021)
Mayo Clinic Laboratories. (2020, June 30).
Mayo Clinic experts to help guide Delta
Air Lines COVID–19 safety measures.
https://newsnetwork.mayoclinic.org/
discussion/delta-engages-mayo-clinic-
experts-to-advise-on-making-travel-even-
safer/. (Mayo Clinic Laboratories, June
30, 2020)
Microbrush. (2020, July 1). Microbrush
Introduces New Nasopharyngeal Test
Swabs. https://www.prnewswire.com/
news-releases/microbrush-introduces-
new-nasopharyngeal-test-swabs-
301087276.html. (Microbrush, July 1,
2020)
Millipore Sigma. (2021, October).
Coronavirus COVID–19 (SARS-CoV–2)
Detection, Characterization, Vaccine and
Therapy Production. https://
www.sigmaaldrich.com/US/en/life-
science/covid. (Millipore Sigma, October
2021)
National Academy for State Health Policy
(NASHP). (2021, October 1). State
Efforts to Ban or Enforce COVID–19
Vaccine Mandates and Passports.
https://www.nashp.org/state-lawmakers-
submit-bills-to-ban-employer-vaccine-
mandates/. (NASHP, October 1, 2021)
National Institutes of Health (NIH) National
Institute of Biomedical Imaging and
Bioengineering (NIBIB). (2021,
September 28). RADx Tech/ATP
Dashboard. https://www.nibib.nih.gov/
covid-19/radx-tech-program/radx-tech-
dashboard. (NIBIB, September 28, 2021)
National Institutes of Health (NIH) National
Institute of Biomedical Imaging and
Bioengineering (NIBIB). (2021, October
14). RADxSM Tech and ATP Programs:
Phase 2 Awards. https://
www.nibib.nih.gov/covid-19/radx-tech-
program/radx-tech-phase2-awards.
(NBIB, October14, 2021)
National Institutes of Health (NIH). (2020,
October 6). NIH RADx initiative
advances six new COVID–19 testing
technologies. https://www.nih.gov/news-
events/news-releases/nih-radx-initiative-
advances-six-new-covid-19-testing-
technologies. (NIH, October 6, 2020)
National Institutes of Health (NIH). (2020,
September 30). NIH to assess and expand
COVID–19 testing for underserved
communities. https://www.nih.gov/news-
events/news-releases/nih-assess-expand-
covid-19-testing-underserved-
communities. (NIH, September 30, 2020)
National Institutes of Health (NIH). (2020,
April 29). NIH mobilizes national
innovation initiative for COVID–19
diagnostics. https://www.nih.gov/news-
events/news-releases/nih-mobilizes-
national-innovation-initiative-covid-19-
diagnostics. (NIH, April 29, 2020)
National Safety Council (NSC). (2021, May
17). SAFER: Safe Actions For Employee
Returns. https://www.nsc.org/getmedia/
f5dfd05d-83bf-4753-8903-
538a24157725/safer-framework-
summary.pdf. (NSC, May 17, 2021)
National Safety Council (NSC). (2021,
September). SAFER Report: A Year in
Review, and What’s Next. https://
www.nsc.org/workplace/safety-topics/
safer/state-of-the-response-state-actions-
to-address-the. (NSC, September 2021)
Puritan Products. (2020, April 20). Puritan
Blog: Puritan at the Epicenter of COVID–
19 Testing. https://
blog.puritanmedproducts.com/puritan-
at-epicenter-of-covid-19-testing. (Puritan
Products, April 20, 2020)
Qiagen. (2021, October 2). COVID–19 Latest
News. https://www.qiagen.com/us/
customer-stories/latest-news-on-the-
fight-against-coronavirus. (Qiagen,
October 2, 2021)
Quest Diagnostics. (2021, September 28).
Quest Diagnostics Media Statement
about COVID–19 Testing. https://
newsroom.questdiagnostics.com/
COVIDTestingUpdates. (Quest
Diagnostics, September 28, 2021)
Quidel Corporation. (2020, July 31). Press
release, Quidel Corp. https://
ir.quidel.com/news/news-release-details/
2020/Quidel-Receives-Preliminary-
Contract-Leading-to-Definitive-
Agreement-for-71-Million-Under-NIHs-
RADx-ATP-Program-to-Accelerate-the-
Expansion-of-Its-Manufacturing-
Capacity-for-Sofia-SARS-CoV-2-Antigen-
Detection-Test-for-Rapid-Diagnosis-of-
COVID-19/default.aspx. (Quidel Corp.,
July 31, 2020)
RiteAid. (2021, October). Free* COVID–19
Testing. https://www.riteaid.com/
pharmacy/services/covid-19-testing.
(RiteAid, October 2021)
Sanford Health. (2021, July 22). Sanford
Health to require COVID–19 vaccine for
employees. https://
news.sanfordhealth.org/news-release/
sanford-to-require-covid-19-vaccine-for-
employees/. (Sanford Health, July 22,
2021)
Trinity Health. (2021, July 8). Trinity Health
Announces COVID–19 Vaccine
Requirement for All Colleagues. https://
www.trinity-health.org/news/trinity-
health-announces-covid-19-vaccine-
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requirement-for-all-colleagues. (Trinity
Health, July 8, 2021)
Tyson Foods. (2021, August 3) Tyson Foods
to Require COVID–19 Vaccinations for
its U.S. Workforce. https://
www.tysonfoods.com/news/news-
releases/2021/8/tyson-foods-require-
covid-19-vaccinations-its-us-workforce.
(Tyson Foods, August 3, 2021)
University of Arizona Center for Rural Health
(ASU CRH). (2021, September 30).
ADHS–CDC COVID Disparities Initiative.
https://crh.arizona.edu/programs/covid-
disparities-initiative. (ASU CRH,
September 30, 2021)
U.S. Department of Defense (DOD). (2021,
March 29) DOD Awards $146.77 Million
Contract to Puritan Medical Products to
Increase Domestic Production Capacity
of Foam Tip Swabs. https://
www.defense.gov/News/Releases/
Release/Article/2554073/dod-awards-
14677-million-contract-to-puritan-
medical-products-to-increase-domes/.
(DOD, March 29, 2021)
U.S. Department of Defense (DOD). (2021,
July 31). DOD Awards $51.15 Million
Undefinitized Contract Action to Puritan
Medical Products Company LLC to
Increase Domestic Production Capacity
of Flock Tip Testing Swabs. https://
www.defense.gov/News/Releases/
Release/Article/2295387/dod-awards-
5115-million-undefinitized-contract-
action-to-puritan-medical-produc/.
(DOD, July 31, 2021)
U.S. Department of Defense (DOD). (2021,
August 23). DOD Awards $0.6 Million
Contract to QIAGEN to Increase
Domestic Production Capacity of
COVID–19 Diagnostic Test Kits and
Reagents. https://www.defense.gov/
News/Releases/Release/Article/2742967/
dod-awards-06-million-contract-to-
qiagen-to-increase-domestic-production-
capaci/. (DOD, August 23, 2021)
U.S. Department of Defense (DOD). (2021,
December 21). DOD Awards $4.8 Million
Indefinite Delivery/Indefinite Quantity
to a Calibre Scientific Subsidiary,
Anatrace, to Increase Domestic
Production Capacity of COVID–19
Testing Reagents. https://
www.defense.gov/News/Releases/
Release/Article/2454163/dod-awards-48-
million-indefinite-deliveryindefinite-
quantity-to-a-calibre-scien/. (DOD,
December 21, 2020)
U.S. Department of Health and Human
Services. (HHS). (2021, June 11). HHS
Provides $424.7 Million to Rural Health
Clinics for COVID–19 Testing and
Mitigation in Rural Communities.
https://www.hhs.gov/about/news/2021/
06/11/hhs-provides-424-million-to-rural-
health-clinics-for-covid-19-testing.html.
(HHS, June 11, 2021)
U.S. Department of Health and Human
Services (HHS). (2021, August 17).
Community based testing sites. https://
www.hhs.gov/coronavirus/community-
based-testing-sites/index.html. (HHS,
August 17, 2021)
Walgreens. (2021, October). Free Drive-Thru
COVID–19 Testing for Ages 3+. https://
www.walgreens.com/findcare/covid19/
testing?ban=covid_hp_cause2.
(Walgreens, October 2021)
Walgreens. (2021, October 8). COVID–19
FAQs. https://news.walgreens.com/our-
stories/covid-19-stories/covid-19-
faq.htm#testinghome. (Walgreens,
October 8, 2021)
Walmart. (2021, July 9). Supporting COVID–
19 Testing. https://
corporate.walmart.com/covid19testing.
(Walmart, July 9, 2021)
Washington Post. (2021, October 6). White
House announces $1 billion purchase of
rapid, at-home coronavirus tests. https://
www.washingtonpost.com/health/2021/
10/06/biden-rapid-at-home-covid-tests/.
(Washington Post, October 6, 2021)
Willis Towers Watson. (2021, June 23)
COVID–19 Vaccination and Reopening
the Workplace Survey press release.
https://www.willistowerswatson.com/en-
US/News/2021/09/workplace-vaccine-
mandates-expected-to-accelerate-wtw-
survey-finds. (Willis Towers Watson,
June 23, 2021)
Willis Towers Watson. (2021, September 1)
Workplace vaccine mandates expected to
accelerate, Willis Towers Watson survey
finds. https://
www.willistowerswatson.com/en-US/
News/2021/09/workplace-vaccine-
mandates-expected-to-accelerate-wtw-
survey-finds. (Willis Towers Watson,
September 1, 2021)
B. Economic Analysis
I. Introduction
This section presents OSHA’s
estimates of the costs and impacts,
anticipated to result from the COVID–19
Vaccination and Testing ETS, 29 CFR
1910.501. The purpose of this ETS is to
address the grave danger of COVID–19
in the workplace by promoting
vaccination, while allowing an
alternative for face covering and testing
requirements, and also to remove
COVID–19 positive workers from the
workplace regardless of vaccination
status. The estimated costs are based on
employers achieving full compliance
with the requirements of the ETS. They
do not include prior costs associated
with firms whose current practices are
already in compliance with the ETS
requirements. The purpose of this
analysis is to:
• Identify the entities/establishments
and industries affected by the ETS;
• Estimate and evaluate the costs and
economic impacts that regulated
entities/establishments will incur to
achieve compliance with the ETS; and
• Evaluate the economic feasibility of
the rule for affected industries.
In this analysis, OSHA is fulfilling the
requirement under the OSH Act to show
the economic feasibility of this ETS.
This analysis is different from the cost
portion of a regulatory impact analysis
prepared in accordance with Executive
Order 12866 in that the agency is
focused only on costs to employers
when evaluating economic feasibility. In
a regulatory impact analysis, the costs to
all parties (e.g., employers, employees,
and governments) are included. While
this is not the case for an economic
feasibility analysis, it does not
necessarily mean that the ETS imposes
no costs or burdens on parties other
than employers. For example, the rule
imposes certain costs on employees who
choose not to become vaccinated (e.g.,
for face coverings and testing. While
these costs are not relevant for the
purpose of establishing economic
feasibility, these costs would be
attributable to the ETS in a regulatory
impact analysis. In addition, these costs
are not mandatory because any
employee who does not wish to pay
them may choose to become vaccinated
or leave employment (see discussion
below on turnover), after which the
costs would not be incurred. Some
employees may also be entitled to a
reasonable accommodation that may
avoid additional cost (e.g., telework).
‘‘[T]he Supreme Court has
conclusively ruled that economic
feasibility [under the OSH Act] does not
involve a cost-benefit analysis.’’ Pub.
Citizen Health Research Grp. v. U.S.
Dept. of Labor, 557 F.3d 165, 177 (3d
Cir. 2009); see also Asbestos Info. Ass’n,
727 F.2d at 424 n.18 (noting that formal
cost benefit is not required for an ETS,
and indeed may be impossible in an
emergency). The OSH Act ‘‘place[s] the
‘benefit’ of worker health above all other
considerations save those making
attainment of this ‘benefit’
unachievable.’’ Cotton Dust, 452 U.S. at
509. Therefore, ‘‘[a]ny standard based
on a balancing of costs and benefits by
the Secretary that strikes a different
balance than that struck by Congress
would be inconsistent with the
command set forth in’’ the statute. Id.
While this case law arose with respect
to health standards issued under section
6(b)(5) of the Act, which specifically
require feasibility, OSHA finds the same
concerns applicable to emergency
temporary standards issued under
section 6(c) of the Act. An ETS ‘‘serve[s]
as a proposed rule’’ for a section 6(b)(5)
standard, and therefore the same limits
on any requirement for cost-benefit
analysis should apply. Indeed, OSHA
has also rejected the use of formal cost
benefit analysis for safety standards,
which are not governed by section
6(b)(5). See 58 FR 16,612, 16,622–23
(Mar. 30, 1993) (‘‘in OSHA’s judgment,
its statutory mandate to achieve safe and
healthful workplaces for the nation’s
employees limits the role monetization
of benefits and analysis of extra-
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22 To support its Asbestos ETS, OSHA conducted
an economic feasibility analysis on these terms. 48
FR 51086, 51136–38 (Nov. 4, 1983). In upholding
that analysis, the Fifth Circuit said that OSHA was
required to show that the balance of costs to
benefits was not unreasonable. Asbestos Info. Ass’n,
727 F.2d at 423. As explained above, OSHA does
not believe that is a correct statement of the
economic feasibility test. However, even under that
approach this ETS easily passes muster.
workplace effects can play in setting
safety standards.’’).22 A standard must
be economically feasible in order to be
‘‘reasonably necessary and appropriate’’
under section 3(8) and, by inference,
‘‘necessary’’ under section 6(c)(1)(B) of
the OSH Act. Cf. Am. Textile Mfrs. Inst.,
Inc. v. Donovan, 452 U.S. 490, 513 n.31
(1981) (noting ‘‘any standard that was
not economically . . . feasible would a
fortiori not be ‘reasonably necessary or
appropriate’ ’’ as required by the OSH
Act’s definition of ‘‘occupational safety
and health standard’’ in section 3(8));
see also Florida Peach Growers, 489
F.2d at 130 (recognizing that the
promulgation of any standard, including
an ETS, must account for its economic
effect). A standard is economically
feasible when industries can absorb or
pass on the costs of compliance without
threatening industry’s long-term
profitability or competitive structure,
Cotton Dust, 452 U.S. at 530 n.55, or
‘‘threaten[ing] massive dislocation to, or
imperil[ing] the existence of, the
industry.’’ United Steelworkers of Am.
v. Marshall, 647 F.2d 1189, 1272 (D.C.
Cir. 1981) (Lead I). Given that section
6(c) is aimed at enabling OSHA to
protect workers in emergency situations,
the agency is not required to make the
showing with the same rigor as in
ordinary section 6(b) rulemaking.
Asbestos Info. Ass’n/N. Am. v. OSHA,
727 F.2d 415, 424 n.18 (5th Cir. 1984).
In Asbestos Information Association, the
Fifth Circuit concluded that the costs of
compliance were not unreasonable to
address a grave danger where the costs
of the ETS did not exceed 7.2% of
revenues in any affected industry. Id. at
424.
The scope of judicial review of
OSHA’s determinations regarding
feasibility (both technological and
economic) ‘‘is narrowly circumscribed.’’
N. Am.’s Bldg. Trades Unions v. OSHA,
878 F.3d 271, 296 (D.C. Cir. 2017)
(Silica). ‘‘OSHA is not required to prove
economic feasibility with certainty, but
is required to use the best available
evidence and to support its conclusions
with substantial evidence.’’ Amer. Iron
& Steel Inst. v. OSHA, 939 F.2d 975,
980–81 (D.C. Cir. 1991) (Lead II); 29
U.S.C. 655(b)(5), (f). ‘‘Courts,
[moreover], ‘cannot expect hard and
precise estimates of costs.’ ’’ Silica, 878
F.3d at 296 (quoting Lead II, 939 F.2d
at 1006). Rather, OSHA’s estimates must
represent ‘‘a reasonable assessment of
the likely range of costs of its standard,
and the likely effects of those costs on
the industry.’’ Lead I, 647 F.2d at 1266.
The ‘‘mere ‘possibility of drawing two
inconsistent conclusions from the
evidence,’ or deriving two divergent
cost models from the data ‘does not
prevent [the] agency’s finding from
being supported by substantial
evidence.’ ’’ Silica, 878 F.3d at 296
(quoting Cotton Dust, 452 U.S. at 523).
Executive Orders 12866 and 13563
direct agencies to assess the costs and
benefits of the intended regulation and,
if regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, and public
health and safety effects; distributive
impacts; and equity). Executive Order
13563 emphasized the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. Because of
the continued impact of the pandemic
on occupational safety and health,
OSHA has prepared this ETS and the
accompanying economic analysis on an
extremely condensed timeline. Thus, in
light of the Secretary’s conclusion that
the COVID–19 pandemic constitutes an
emergency situation, the Secretary has
notified OIRA that it is necessary for
OSHA to promulgate this regulation
more quickly than normal review
procedures allow, pursuant to E.O.
12866 Sec. 6 (a)(3)(D). OIRA has waived
compliance with Sec. 6(a)(3)(B) and (C)
for this economically significant rule.
II. COVID–19 ETS Industry Profile
a. Introduction
In this section, OSHA provides
estimates of the number of affected
entities, establishments, and employees
for the industries that have settings
covered by this ETS. The term ‘‘entity’’
describes a legal for-profit business, a
non-profit organization, or a local
governmental unit, whereas the term
‘‘establishment’’ describes a particular
physical site of economic activity. Some
entities own and operate more than one
establishment.
Throughout this analysis, where
estimates were derived from available
data those sources have been noted in
the text. Estimates without sources
noted in the text are based on agency
expertise.
b. Scope of the COVID–19 ETS
This ETS applies to all employers
with a total of 100 or more employees
at any time this ETS is in effect.
However, the requirements of this ETS
do not apply to: (1) Workplaces covered
under the Safer Federal Workforce Task
Force COVID–19 Workplace Safety:
Guidance for Federal Contractors and
Subcontractors (Contractor Guidance);
or (2) settings where any employee
provides healthcare services or
healthcare support services when
subject to the requirements of 29 CFR
1910.502 (i.e., the Healthcare ETS).
Furthermore, the requirements of this
ETS do not apply to the employees of
covered employers: (1) Who do not
report to a workplace where other
individuals, such as coworkers or
customers, are present; or (2) while
working from home; or (3) who work
exclusively outdoors. Based on this
scope, employers in nearly every sector
are expected to be covered by this ETS.
OSHA’s assumptions may result in an
overestimate of the number of
employees affected by the ETS. First,
OSHA is not estimating the number and
type of workplaces covered by the Safer
Federal Workforce Task Force COVID–
19 Workplace Safety: Guidance for
Federal Contractors and Subcontractors
or removing them from the profile of
employers affected by this ETS. OSHA
assumes for the purpose of this analysis
that employers covered under the
Contractor Guidance will also have
contracts to perform work in workplaces
where they are not covered under that
Guidance (i.e., where the employer
contracts with an entity other than the
federal government), and so those
employers are included in the scope
here.
Second, OSHA estimates that all
employers in all private sector
industries are affected by this ETS to
some extent. Although this ETS imposes
no compliance burden on employers
whose employees work remotely 100
percent of the time, in OSHA’s analysis,
no employers with 100 or more
employees have all of their employees
working remotely 100 percent of the
time (i.e., at least some employees in
each affected firm do not work
remotely). Moreover, OSHA’s analysis
does not take into account that some
employees may engage in part-time
telework (i.e., it assumes that employees
either work remotely full-time or do not
work remotely at all). Finally, OSHA’s
analysis does not fully take into account
the exemption for employees who do
not report to a workplace where other
individuals are present, meaning that
this analysis may overestimate the
number of employees affected by the
rule.
As stated, the requirements of this
ETS do not apply to the employees of
covered employers who work
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exclusively outdoors. To determine the
percentage of employees in occupations
for which the exception is relevant, the
agency uses data from the BLS’s 2020
Occupational Requirements Survey
(ORS) (BLS, 2020). This survey looks at
various aspects of job requirements. In
particular, the survey lists occupations
where workers are outdoors
‘‘constantly,’’ which OSHA interprets as
being nearly continuously outdoors.
Because the majority of workers who
work outdoors ‘‘constantly’’ likely work
indoors at least some of the time, the
agency judges that no more than 10
percent of the workers who are
primarily outdoors are actually there
exclusively. See Table IV.B.1 for the
occupations, the ORS percentages, and
final percentages for workers OSHA
estimates are exempt from the scope of
this ETS based on the outdoor work
exemption.
OSHA’s estimate of employees who
work exclusively outdoors does not
account for employers who only need to
make slight adjustments to their current
work practices to ensure that their
employees qualify for the outdoor
exemption, such as by holding tool box
talks outdoors instead of in a traditional
indoor location. This may result in more
employees falling within the exemption
than estimated by OSHA; therefore,
OSHA’s cost analysis likely
overestimates costs.
The requirements of the ETS also do
not apply to settings where any
employee provides healthcare services
or healthcare support services when
subject to the requirements of 29 CFR
1910.502 (the Healthcare ETS). The
Healthcare ETS is a temporary standard
that may not remain in effect for the
entire period that 29 CFR 1910.501
remains in effect. This means that some
employers or employees covered by the
Healthcare ETS, those in firms that have
100 or more employees, may ultimately
be covered by 29 CFR 1910.501 (because
the exception in 29 CFR 1910.501 is
limited to when employers are subject
to the requirements of the Healthcare
ETS). This potentially impacts two
types of costs: Employer-based costs
(e.g., employer policy on vaccination)
and employee-based (periodic) costs
(e.g., recordkeeping).
Employer-Based Costs: For the
purpose of the economic analysis only,
OSHA treats the Healthcare ETS as
though it will no longer be in effect after
December, 2021, because at that point
the Healthcare ETS will have been in
effect for the six months that OSHA had
calculated costs for that ETS. Therefore,
OSHA estimates that some employers
including those with 100 or more
employees subject to the 29 CFR
1910.502 exemption, will need to take
employer-based costs because all these
employers will ultimately be subject to
29 CFR 1910.501 under this assumption.
Employee-Based Costs: OSHA’s
estimates incorporate two assumptions
for the purposes of this analysis only.
First, for the purposes of assumptions
for this analysis only, § 1910.501 will
remain in effect for 6 months. Second,
many employers and employees
currently covered only by the
Healthcare ETS will be subject to the
requirements of 29 CFR 1910.501 for
approximately 4 months (4 months of
the 6 month estimated lifespan of 29
CFR 1910.501). OSHA’s estimate of
those employees exempted by the
Healthcare ETS was based on the
Industry Profile of employees in firms
with 100 employees or more covered by
the Healthcare ETS, as estimated in
Table VI.B.3 in the economic analysis
for that rulemaking (see 86 FR 32488).
OSHA notes that some employees
currently covered by the Healthcare ETS
might also be currently covered by 29
CFR 1910.501 (albeit at different times
or in different locations) because the
Healthcare ETS is settings-based. For
example, a pharmacist would normally
not need to comply with the
requirements of § 1910.502 when just
filling prescriptions in a retail pharmacy
store (see 29 CFR 1910.502(a)(2)(ii)), but
would need to comply when
administering vaccinations within an
embedded clinic inside that retail
pharmacy. Thus, there are a number of
variables that could impact the extent to
which the pharmacist’s employer might
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23 The CMS rule published elsewhere in this issue
of the Federal Register mandates vaccination for
employees in facilities that receive Medicare or
Medicaid. OSHA is ignoring this for the purpose of
its cost analysis and taking costs into account as if
the CMS rule were not promulgated. This creates
a substantial overestimate.
incur any costs. However, even to the
extent that such costs might occur (e.g.,
recordkeeping for testing if the
pharmacist works for an employer
covered by 29 CFR 1910.501 and is
unvaccinated), OSHA judges that they
would be de minimis for several
reasons. First, this pool of workers is
likely to be very small, especially when
compared to the population of workers
covered by the Healthcare ETS. Second,
most employees subject to both
standards will have been fully
vaccinated before OSHA takes costs for
these employees under 29 CFR 1910.501
by operation of the CMS rule mandating
vaccination or as a result of the
voluntary vaccination incentives
promoted by OSHA’s Healthcare ETS
(therefore negating most of the costs
associated with vaccination and testing
under 29 CFR 1910.501). Third, any
underestimate of periodic costs will
only apply during the first two months
after 29 CFR 1910.501 goes into effect
and the standard has a delayed
compliance date of 30 days after the
effective date for most provisions,
except for testing, which has a delayed
compliance date of 60 days. This will
further lessen the periodic costs
associated with any potential
underestimate.
In all respects (other than the 4⁄6 share
of employee-based costs), OSHA is
taking the same approach in the
Industry Profile and Cost Estimates for
employers and employees currently
covered by the Healthcare ETS as it does
for all other industries. These employers
and employees are fully integrated into
Table IV.B.5, below, which contains a
summary of covered entities and
employees. Moreover, the same
assumptions on outdoor work and other
scope exemptions that OSHA explains
earlier holds for these employers and
employees. In addition, OSHA makes
the same downward adjustment in
telework for these employers and
employees in accordance with the
methodology it sets out below. Thus, the
Healthcare ETS profile used in this ETS
to account for employees exempted by
the Healthcare ETS into the Profile in
the event the Healthcare ETS expires
(i.e., in Table IV.B.5, below) is an
updated version of Table VI.B.3 in the
Healthcare ETS (see 86 FR 32488).23
OSHA notes that some firms may decide
to proactively comply with certain 29
CFR 1910.501 requirements (such as
mandating vaccination for all employees
that were removed from the Industry
Profile) before the end date of the
Healthcare ETS based on the conclusion
that 29 CFR 1910.501 will ultimately
apply in full to them. Since these costs
still occur due to 29 CFR 1910.501,
OSHA is appropriately including them
in this cost analysis.
There are 9.9 million employees who
will newly be covered by 29 CFR
1910.501 starting in December whose
employers will incur an additional $318
million in costs. These costs are
integrated into the agency’s main cost
analysis, which is described later in this
economic analysis.
Only some state- and local-
government entities are included in this
analysis. State- and local-government
entities are specifically excluded from
coverage under the OSH Act (29 U.S.C.
652(5)). Workers employed by these
entities only have OSH Act protections
if they work in states that have an
OSHA-approved State Plan. (29 U.S.C.
667). Consequently, this analysis
excludes public entities in states that do
not have OSHA-approved State Plans.
Table IV.B.2 presents the states that
have OSHA-approved State Plans and
their public entities are included in the
analysis.
OSHA notes, finally, that the
percentage of employers mandating
vaccination, and hence the employee
vaccination rate, would likely rise to
some degree absent this ETS due to
other federal actions, such as the
vaccination mandate for federal
contractors, the CMS rule published
elsewhere in this issue of the Federal
Register, and as a result of vaccination
mandates that have been adopted at
state and local levels. This analysis does
not account for increases in vaccination
that would occur absent the standard,
resulting in a likely overestimate of the
costs.
c. Teleworking
Dingel-Neiman Approach for Estimating
Who Can Work Remotely
OSHA uses the estimates in a paper
by J.I. Dingel and B. Neiman, ‘‘How
Many Jobs Can be Done at Home?,’’
published in July 2020, as a starting
point to determine the percentage of
employees, by occupation, who are not
expected to work remotely (i.e., the
percentage of workers for whom
employers have employee-based costs
under this ETS) (Dingel and Neiman,
July 2020).
In Dingel and Neiman’s paper, the
authors estimate the number of jobs in
the U.S. economy that workers can
feasibly perform remotely. The authors
use two different surveys from the
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24 24 The O*Net Program is a major source of
occupational information for the U.S. The O*NET
database surveys ask both specific occupational
experts and workers in those occupations questions
covering multiple aspects of almost 1,000
occupations covering the entire U.S. economy. See
https://www.onetonline.org/ for more information.
The occupation definitions in the O*NET data are
Standard Occupation Codes—the same definitions
that are used in the BLS OEWS data. Dingel and
Neiman use the responses to two surveys included
in release 24.2 of the database administered by
O*NET, the Worker Context Questionnaire and the
Generalized Work Activities Questionnaire. The
occupation with the median number of respondents
had 26 respondents for each work context question
and 25 respondents for each generalized work
activities question per detailed-level SOC
occupation code.
In the O*Net Questionnaires, survey respondents
responded to statements about the nature and
requirements of the daily tasks associated with their
job on a 1–5 ordinal scale, where 5 represents the
strongest agreement and 1 represents the strongest
disagreement (see Table IV.B.3). The O*Net data
contain the average response to each question for
each occupation code. For instance, for occupation
‘‘Chief Executives’’ (SOC 11–1011), the average
response to the prompt ‘‘Performing General
Physical Activities is very important’’ was 1.39,
indicating that performing general physical activity
is not, on average, critical to the work of chief
executives. The average responses by occupation for
other prompts in the relevant surveys utilized by
Dingel and Neiman are contained in those surveys.
Occupational Information Network
(O*Net) 24 to evaluate which
occupations can be performed remotely
and combine the O*Net estimates with
the Bureau of Labor Statistics’ (BLS)
Occupational Employment and Wage
Statistics (OEWS) data on employment
by occupation to estimate the total
number of workers nationally who can
work remotely.
To evaluate the survey responses,
Dingel and Neiman first determined the
occupations for which the average
response to a given prompt met a preset
threshold. Table IV.B.3 presents the
Dingel and Neiman response threshold
for each survey question as well as the
percent of occupations that meet each
respective predetermined threshold. For
example, in 10.8 percent of occupations,
the average response to the ‘‘Performing
general physical activities’’ (4.A.3.a.1)
question met the threshold, falling in
the range of 4 to 5.
Dingel and Neiman determined that
employees in a given occupation can
telework full time if they did not meet
the predetermined threshold for any of
the questions highlighted in grey and
denoted with a ‘‘Yes’’ in the column
that reports whether that activity is used
in determining whether a job can be
done remotely in Table IV.B.3.
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Source: (Dingel and Neiman, July 2020).
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25 Except for the adjustments to Dingel and
Neiman discussed above, OSHA used the Dingel
and Neiman estimates for telework by occupation
without change. The agency recognizes that the
authors’ methodology (i.e., the use of 0–1
thresholds) led to a small number of results that
may appear not to reflect real-world experiences
within an occupation. However, Dingel and Neiman
represents the best available evidence for
determining the percentage of employees, by
occupation, who are expected to work remotely.
OSHA is aware of no other source for this
information that contains the level of detail
necessary to conduct this analysis. Moreover, as
explained above, OSHA modified the results for
individual occupations when it had a reasoned
basis for doing so. In any event, every NAICS
industry is comprised of many occupations, so for
every occupation where OSHA suspects remote
work is overestimated in Dingel and Neiman’s
results, there may be another where remote work is
underestimated.
26 The CPS data were available only at the 2-digit
NAICS level as shown in Table IV.B.4.
Adjusting Dingel and Neiman To Reflect
Current Conditions
While many employees can and are
working remotely, many have returned
to their places of employment. This
conclusion is borne out by BLS’s
Current Population Survey (CPS) (BLS,
2021c). To address the tendency toward
employees returning to work on site and
more accurately reflect current remote
work conditions, OSHA made two
adjustments to Dingel and Neiman’s
estimates. In the COVID–19 Healthcare
ETS, OSHA also used Dingel and
Neiman’s paper to estimate the number
of workers who teleworked in response
to the pandemic and the ETS under the
assumption that anyone who could
work remotely would do so in response
to the pandemic and the Healthcare
ETS. Dingel and Neiman’s estimates are
therefore framed as the upper-bound of
potential teleworking.
The adjustments OSHA made reflect
changing circumstances. First, based on
agency expertise, OSHA changed the
status of certain occupations in its
occupational list from working remotely
to not working remotely. For example,
when Dingel and Neiman published
their study, many schools were
operating virtually so the Dingel and
Neiman finding that teachers were able
to work remotely lined up with the
situation where teachers were working
remotely. At this point in the pandemic,
on the other hand, in-person learning
has mostly recommenced. To this end,
OSHA changed the status of teachers
and other employees in the education
sector from working remotely to not
working remotely in this analysis. As
another example, many activities that
ceased or were reduced significantly
have now resumed and many locations
that were closed to the public have
reopened (e.g., athletic events, shows,
gyms, casinos and places of worship),
and, since more people have returned to
the office, there is more need for
childcare. Therefore, OSHA also
changed the status of these employees
and others from telework to non-
telework. This has the ultimate effect of
increasing costs estimates for the rule.
Appendix A (Table A–1), in the
accompanying document in the docket,
‘‘Vaccination, and Testing ETS:
Economic Profile and Cost Chapter
Appendices’’ (OSHA, October 2021b),
presents Dingel and Neiman’s (July
2020) unmodified percentages of
workers that can work remotely in each
detailed occupation (based on BLS’s
Standard Occupation Code (SOC)).25
Appendix A also presents, in separate
columns, percentages reflecting the
modifications OSHA made in those
occupations where OSHA changed the
results from telework to non-telework
for the reasons stated, as well as
percentages reflecting the modifications
made in occupations where employees
work exclusively outdoors.
According to the OSHA-adjusted
Dingel and Neiman estimates, 14
percent of the jobs in the United States
are performed entirely at home, with
significant variation across cities and
industries. It should be noted that the
Dingel and Neiman analysis does not
specify a proportion of jobs that can be
performed at home part of the time;
under the analysis, employees are either
working remotely full-time or are
working on site full time.
The second adjustment OSHA made
used monthly COVID-specific
teleworking data from telework
questions added during the pandemic to
the CPS to estimate the reduction in
teleworking since its peak and applied
those estimates to further adjust
downward the number of workers
currently teleworking (BLS, 2021c).
Specifically, the CPS questions asked
respondents whether they were
teleworking due to COVID–19 (as
opposed to teleworking for other
reasons) and OSHA estimated the
difference in teleworking from the peak
of COVID-related teleworking in all
industries, which occurred in May 2020,
through August 2021 (see Table
IV.B.4).26 The reduction in teleworking
was then applied as the change in
percentage points to the estimated
overall level of employees covered by
the ETS in each NAICS code estimated
based on data from Dingel and Neiman
(July 2020). OSHA’s final teleworking
estimates are provided in Appendix B in
the accompanying document in the
docket, ‘‘Vaccination, and Testing ETS:
Economic Profile and Cost Chapter
Appendices’’ (OSHA, October 2021b).
Reductions due to employees working
exclusively outdoors were applied to
reduce the percentage of covered
employees in Appendix B as well.
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Other Teleworking Literature
A number of companies have
announced plans to allow employees to
work from home at least through the
end of 2021—suggesting that the levels
of remote work will not be returning to
pre pandemic levels in the near future.
Many technology and internet based
companies, such as Dropbox, Coinbase,
VMWare, and Slack, have announced a
complete, permanent move to fully
remote work (Courtney, September 27,
2021). Large employers such as
Facebook, Amazon, and Siemens plan to
maintain some physical workspace but
now offer their employees who are
telework eligible the option to work
from home at least part of the time on
a permanent basis (Id.). Google, Ford,
Amazon, Apple and other large
employers are expecting their telework
eligible workers to return to on-site
work (in some capacity) no earlier than
January 2022 with Lyft anticipating a
February 2022 return (Cerullo, August
31, 2021). As a final example, a survey
of businesses in Massachusetts found
that about 40 percent of teleworkers
anticipate they will not be returning to
the office in January 2022 or earlier
(Chesto, June 22, 2021).
Additional studies provide qualitative
support for the conclusion that a range
of employees will ‘‘predictably’’ work
from home both during the pandemic
and beyond. In Bick, Blandin, and
Martens’s paper, ‘‘Work from Home
Before and After the COVID–19
Outbreak’’ the authors use the following
information to establish the physical
location of employment (home or
workplace) of workers: Data from the
Real-Time Population Survey (RPS), a
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27 SUSB with revenue data is only collected every
5 years. While OSHA could attempt to extrapolate
these data to more recent years, the results would
be imprecise because they would change the
revenue-employee size distributions. Those
distributions are crucial for measuring impacts so
the agency has opted to use the data as is. The total
number of employees in OSHA’s estimate is fairly
close to that of SUSB. The 2017 SUSB data includes
a total of 128.6 million employees, while the more
recent 2018 SUSB data includes a total of 130.9
million.
28 This includes public entities only in states with
an approved OSHA State Plan. See Table IV.B.2
above for further discussion of state plans.
29 OSHA’s estimate of covered employees is based
on the discussion in the text. For example, as OSHA
writes above: OSHA assumes for the purpose of its
analysis that employers covered under the
Contractor Guidance will conduct work at least
some of the time in workplaces not covered under
that Guidance and so are fully integrated into the
scope of the ETS; and the employers and employees
covered by the Healthcare ETS are also fully
integrated into the scope of the ETS.
30 Conditions are changing rapidly, and though
many firms are planning to keep expanded telework
to some extent, as the rate of vaccinated workers
increases, there may be increased movement back
to the workplace beyond what OSHA has estimated
here.
national labor market survey of adults
between ages 18–64 that mirrors the
Current Population Survey (CPS) and
collects information used in pandemic
analysis, such as commuting behavior
before and after the World Health
Organization declared a global
pandemic; mobility data on commuting;
and information from the CPS since
May 2020 on ‘pandemic-related’
telework (Bick et al., February 2021).
Based on these data, Bick et al., found
that there was a sudden decline in
commuting trips in the U.S. after the
initial COVID–19 outbreak, and that
even when these trips subsequently
began increasing back toward the
original number of commuting trips, the
overall number of trips did not return to
normal at the end of 2020 because many
teleworking employees continued
working from home. The authors found
that the surge in work from home came
almost entirely from employees working
from home every workday in the
reference week. The authors also suggest
that, for some occupations, especially
those occupations with more educated
workers, the change to increased work
from home appears to be a long-term
change; the data showed that, as of
December 2020, 12.5 percent of these
workers reported they expect to be
working from home full-time in the
future, and 24.5 percent reported they
expect to be working from home part-
time.
In ‘‘COVID–19 and Remote Work: An
Early Look At U.S. Data,’’ Brynjolfsson
et al., noted that some of the shift to
working from home seems to be a long-
term phenomenon (Brynjolfsson et al.,
June 2020). The authors found, using an
online survey, that 35.2 percent of
workers had switched to working from
home. Additionally, 15 percent of
workers reported they were already
working from home before COVID–19.
Therefore, this study finds that about
half of workers are now working from
home—an even greater percentage than
estimated by Dingel and Neiman.
Finally, in ‘‘Why Working from Home
Will Stick,’’ Barrero et al. predict that 22
percent of all full workdays will be
performed from home after the
pandemic ends, compared to 5 percent
before (Barrero et al., April 2021). The
authors highlight five factors
contributing towards the more
permanent shift to telework: Diminished
stigma, better-than-expected
experiences working from home,
investments in physical and human
capital enabling work from home,
reluctance to return to pre-pandemic
activities, and innovation supporting
work from home.
d. Affected Entities and Employees
OSHA used data from the U.S.
Census’ 2017 Statistics of U.S.
Businesses (SUSB) to identify private
sector entities and employees affected
by this section of the ETS (U.S. Census
Bureau, 2019), and used the BLS 2017
Quarterly Census of Employment and
Wages (QCEW) to characterize state and
local government entities (BLS, 2017).
SUSB provides estimates of entities and
employees by employer size range,
which OSHA used to exclude employers
with fewer than 100 employees.27
For rail transportation (NAICS 482),
which is not included in SUSB or
QCEW data, OSHA relied on Federal
Railroad Administration and
Association of American Railroads
statistics reported in OSHA’s 2020 final
rule, Cranes and Derricks in
Construction: Railroad Roadway Work.
See 85 FR 57109 (September 15, 2020).
OSHA used these data sources to
identify public and private railroad
employers with more than 100
employees. For agricultural NAICS (111
and 112), OSHA relies on the National
Agricultural Statistics Service, 2017
Census of Agriculture (NASS, 2017) to
obtain estimates of total entities,
employees, and revenues. Since these
data do not indicate the number of
entities with more than 100 employees,
OSHA assumes it is the same as the
average proportion as the support
activity sectors for crop and animal
production (NAICS 114 and 115). OSHA
similarly specifies teleworking
conditions for NAICS 111 and 112 using
the average result for support activities
for agriculture (NAICS 114 and 115). For
the postal service industry, NAICS
491110, which is not included in SUSB,
OSHA obtains total entity and
employment data for private postal
services from the QCEW. Since these
data do not indicate the number of
entities with more than 100 employees,
OSHA assumes it is the same as the
average proportion as the related
industries, couriers and express delivery
(NAICS 492110), and local delivery
(NAICS 492120).
OSHA used the BLS 2020
Occupational Employment and Wage
Statistics (OEWS), which provides
NAICS-specific estimates of
employment and wages by occupation,
along with the data in Appendix B
(discussed earlier), to determine the
subset of non-teleworking employees
affected by the ETS.
Table IV.B.5 summarizes the set of
entities covered by the ETS. OSHA
estimates a total of approximately
263,879 entities and approximately 1.9
million establishments incur costs
under the ETS.28 OSHA estimates these
entities employ approximately 102.7
million employees, and of these, OSHA
estimates approximately 84.2 million
employees are covered by the ETS and
are not excluded from coverage by
working remotely 100 percent of the
time or exclusively outside.29 For the
purpose of this analysis, OSHA
estimates that all employees that OSHA
estimated will work remotely will
continue to do so for the duration of this
ETS.30
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31 The data from the CDC website was retrieved
on October 4, 2021.
32 Age groups included: 18–24, 25–39, 40–49, 50–
64, and 65–74. OSHA had not included the group
65–74 in the economic analysis of the Healthcare
ETS this past spring because for the healthcare
sector, using the population wide average of
workers in this age bracket was felt would
overcount the number of such workers in this
sector. OSHA is including this group now that more
of the other age populations have been vaccinated
and those concerns are no longer as relevant. This
ETS will therefore indicate that a slightly higher
percentage of universe of covered employees is
vaccinated than if that age group of 65–74 was
excluded altogether, but it also increases the
number of employees for which additional
compliance costs are factored in. OSHA interprets
the ultimate result as a more accurate reflection of
the workplace and notes that more costs are
included than if the age group had been excluded
from the analysis.
33 The agency takes a recent survey (Lazer et al.,
August 16, 2021) which breaks out rates for
healthcare vaccination and non-healthcare, and
rather than replacing the CDC base vaccination rate
uses the CDC rate to make an adjustment upwards
to the healthcare rate of 70 percent.
III. Baseline Vaccine Status for Covered
Employees
To estimate the cost of the ETS,
OSHA must first estimate the baseline
vaccination status for the 84.2m covered
employees (those who work for
employers with 100 or more employees
and are not otherwise excluded from
coverage). OSHA recognizes that
employees’ current vaccination status
continues to change on a daily basis.
When specifying baseline vaccination
rates, OSHA used the most recently
available vaccination data from CDC,
reflecting current conditions. For the
remaining set of unvaccinated
employees covered by the ETS, after
accounting for baseline vaccinations,
OSHA estimates the number of these
employees who will be vaccinated and
the number who will test under the
ETS. OSHA’s methodology for this
analysis is detailed below.
a. Estimate the Current Vaccination Rate
for Covered Employees
To estimate the current vaccinate rate
for covered employees, OSHA obtained
recent vaccination data by age group
from the CDC COVID Data Tracker
(CDC, October 4, 2021a).31 For age
groups covering 18–74 years old, these
data include the number of people who
are fully-vaccinated as well as the
number of people of who have initiated
their first shot in the past two weeks
(relative to the October 4, 2021 data).32
OSHA estimates the vaccination rate for
each group (percent of total population
in the age group who are vaccinated)
based on the total number of people
who are fully-vaccinated and had their
first shot in the past two weeks, as a
fraction of the population in each age
group, obtained from the BLS Current
Population Survey (CPS) (BLS, 2021d).
Then, to estimate the overall average
vaccination rate across age groups 18–74
years old, OSHA weighted each group
based on the distribution of the labor
force by age, also obtained from the BLS
CPS (BLS, 2021d). As shown in Table
IV.B.6, OSHA estimates an overall
vaccination rate of 61.3 percent for
covered employees (and 38.7 percent
unvaccinated). The healthcare sector
had an earlier push to get healthcare
workers vaccinated and has a higher
current rate, estimated to be 70
percent.33
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34 Table 6a presents that 3,884,902 of the
population will not take the vaccine because the
‘‘doctor has not recommended it’’ out of a total of
38,936,606 who will not get the vaccine for any
reason. Medical reasons are then about 10% of the
general population that will not get the vaccine, and
the ones who won’t get the vaccine are about 10%
of the whole population, giving 1% (.10 * .10).
Based on the above, OSHA estimates
that the 84.2m covered employees
includes 52.5 million (62 percent)
vaccinated employees and 31.7 million
unvaccinated employees (38 percent).
b. Adjust Baseline Vaccination for
Continuing Trends
OSHA adjusts the current vaccination
rate to account for continuing trends in
vaccinations among covered employees
due to employers’ continued
implementation of vaccine mandates
and other policies (described below),
under the ETS. To make this
adjustment, OSHA requires 1) further
characterization of the set of
unvaccinated employees in terms of
their likelihood to receive the vaccine,
and 2) specification of the extent of
employer-mandated and other employer
vaccination policies.
Based on vaccine confidence data
from CDC (CDC, October 2021a), 13.8
percent of the population ‘‘probably or
definitely will not’’ get the vaccine;
hereafter referred to as ‘‘vaccine-
hesitant’’. Since this group is by
definition part of the currently
unvaccinated, OSHA characterizes the
currently unvaccinated (37.6 percent) as
being comprised of those who are
vaccine—hesitant (13.8 percent) and the
remainder, who while unvaccinated, are
not hesitant because they are not in the
‘‘probably or definitely will not’’ group
(23.8 percent).
Among those who are vaccine-
hesitant, OSHA estimates that 5 percent
of covered employees (or about 36
percent of the vaccine-hesitant), are
hesitant due to a religious (4 percent) or
medical (1 percent) exemption. The
remaining 8.8 percent include those
who are vaccine-hesitant for other
reasons. For the 4 percent estimate for
religious exemptions, OSHA relies on
data from Vermont, which removed its
vaccine exemption for nonreligious
personal beliefs in 2016 and saw the
proportion of kindergarten students
with a religious exemption rise to about
4 percent (Graham, September 15,
2021). In analyzing this issue, the
agency also reviewed other religious
exemption data concerning state
workers in Oregon and Washington; the
agency decided not to rely on these data
because the Vermont data is a more
accurate measure of the correct religious
exemption rate, although the data does
represent parents deciding on whether
to claim an exemption for their child,
not for themselves. This is because,
unlike the Vermont data, the Oregon
and Washington data contain workers
that have applied, but not yet been
accepted, for a religious exemption
(O’Sullivan, September 18, 2021; KEZI
News, September 25, 2021). In Oregon,
5 percent and in Washington 8 percent
of the employees have requested
accommodations though only a fraction
so far have been accepted. However, the
data are not inconsistent with the
Vermont data even though the process
in both Oregon and Washington are not
yet complete. For the 1 percent estimate
for medical exemptions, OSHA relied
on the Household Pulse Survey (HPS)
conducted by the U.S. Census (U.S.
Census Bureau, 2021). In Table 6a of the
Health Tables for Week 31, September 1,
2021 through September 13, 2021, about
1% of the US population said they
would not get the vaccine because
‘‘Doctor has not recommended it,’’ and
OSHA uses this response as a proxy for
all medical conditions.34
Table IV.B.7 presents the number of
employees in each vaccination category,
which informs OSHA’s subsequent
estimates of which currently
unvaccinated employees may be
vaccinated by employer-mandates,
vaccinated under the ETS, or tested
under the ETS.
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35 OSHA notes that these estimates differ for
employees covered by the Healthcare ETS. OSHA
calculated these estimates separately because, as
stated above, OSHA is only taking costs for these
employees in the last four months of the assumed
6-month period while the ETS remains in effect.
While OSHA does not describe in detail how it
derived estimates for employees covered by the
Healthcare ETS in this analysis, the derivation of
those estimates run parallel to those described
above. For more information, please see the
spreadsheets supporting this analysis. (OSHA,
October 2021a).
Next, OSHA estimates the number of
currently unvaccinated employees that
are likely to become vaccinated while
the ETS is in effect, based on their
employers’ policies. Based on limited
data on current vaccine mandate
implementation and forecasts for future
implementation (Mishra and Hartstein,
August 23, 2021; ASU COVID–19
Diagnostic Commons, October 6, 2021),
OSHA estimates that 25 percent of firms
in scope currently have a mandate, and
assumes that this will rise to 60 percent
of employers after the ETS is in place.
The baseline of 25 percent is based on
recent surveys showing a range of
approximately 13–45 percent of
employers currently requiring or
planning to require vaccination among
employees (see Willis Towers Watson,
June 23, 2021; Mishra and Hartstein,
August 23, 2021; ASU COVID–19
Diagnostic Commons, October 6, 2021).
Absent the ETS, OSHA assumes that the
percentage of firms would remain 25
percent (with some measure of upward
adjustment due to other federal vaccine
mandates affecting select populations,
as discussed above). To the extent more
firms than OSHA estimates would
mandate vaccination independent of the
ETS and thereby increase the
vaccination rate (again because of
factors such as other federal vaccine
mandates), then the agency’s costs are
overestimated because the agency’s
baseline vaccination rate is too low. The
assumption of an increase from 25 to 60
percent is based on the same set of
surveys that indicate that the share of
employers who will mandate
vaccinations after the ETS (including
those that already mandate
vaccinations) range from 25–75 percent,
see above references. The agency also
assumes that employees are distributed
in the same proportion across employers
with and without a vaccine mandate
(e.g., if 60 percent of firms mandate
vaccination, 60 percent of employees
will be vaccinated due to the mandate
(less those who remain unvaccinated
due to religious or medical exemptions).
OSHA assumes that all unvaccinated
employees subject to an employer
mandate will be vaccinated under that
employer mandate, except for those
seeking a medical or religious
exemption. For unvaccinated employees
not subject to an employer mandate,
OSHA assumes that they will also be
vaccinated at their employer’s request,
except for employees who are vaccine-
hesitant, which includes not only those
who remain unvaccinated for medical
and religious reasons, but also those
who are hesitant for any other reason.
OSHA carries through its assumptions
and estimates into its total cost
estimates. For example, OSHA estimates
that the 25 percent of firms in scope that
currently have a vaccination mandate
will not need to implement a new
written policy on vaccination in
response to the ETS since they will
already have implemented a policy that
meets the requirements of the ETS.
In total, OSHA estimates that 27
percent of covered employees (22.7
million) will be vaccinated based on
employer policies under the ETS; or 72
percent of covered employees who are
currently unvaccinated. The resulting
vaccination rate, adjusted for the ETS, is
estimated based on the total of those
who are currently vaccinated and those
who will be vaccinated under employer
policies, 89.4 percent as shown in Table
IV.B.8. Calculations of this nature, while
not discussed in more detail in this
analysis, are contained fully in the
spreadsheets supporting this analysis
(OSHA, October 2021a).35
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From Table IV.B.8, OSHA estimates
that approximately 75.3 million (89.4
percent) of covered employees will be
vaccinated when the ETS is in full
effect, and that approximately 8.9
million employees (10.6 percent, made
up of approximately 6.3 million covered
employees who will be tested for COVID
under the ETS and approximately 2.6
million employees who return to
telework (see next paragraph)) will
remain unvaccinated. This final set of
unvaccinated employees includes all
employees not vaccinated because of
religious or medical accommodations or
medical contraindication, plus the
portion of those who are vaccine-
hesitant for any other reason, who were
not vaccinated because their employer
has opted for a voluntary vaccination
policy.
From the above, OSHA estimates that
about 5 percent of all covered
employees will seek and receive
religious or medical accommodations or
exemption for medical contraindication.
While the agency encourages employers
to consider the most protective
accommodations such as telework,
which would prevent the employee
from being exposed at work or from
transmitting the virus at work, for cost
analysis purposes the agency assumes
these workers will largely be tested in
order for their employers to comply
with the ETS. Consistent with the
overall average 22 percent of those who
returned to work after teleworking
earlier in the pandemic (see teleworking
discussion above), OSHA assumes for
this cost analysis that only 22 percent of
workers needing a reasonable
accommodation will return to full time
telework as a reasonable
accommodation. OSHA also assumes
that the 78 percent remainder will
follow the testing/masking protocols in
the ETS as a reasonable accommodation.
For hesitant employees who will not
seek a religious or medical
accommodation, and who work in a
firm with a testing option, the agency
assumes as above that those who were
teleworking before (again on average 22
percent) will return to telework rather
than being tested.
c. Cost of Absenteeism to Employers
Even mild cases of Covid-19 can be
costly to employers as they can induce
productivity losses due to work
absences, both among those infected
and their close contacts who may be
subject to quarantine requirements.
While many workers were able to
engage in telework in March-April 2020,
several occupational groups deemed
essential, including childcare workers,
personal care aids, healthcare support
occupations, and food processing
workers, exhibited significantly higher
rates of absenteeism during that period,
which the authors attributed to some
workers contracting COVID–19
(Groenewold et al., July 10, 2020).
Absenteeism can also affect the
productivity of workers who are
present, similar to how turnover can
impose costs on incumbent workers
(Kuhn and Yu, April 2021).
In aggregate, productivity losses from
absences can be costly, as evidenced by
the economic losses from seasonal
influenza. One estimate found that the
United States loses 20.1 million days of
economic productivity every year due to
influenza, an ongoing loss equivalent to
80,400 full-time worker-years (Putri et
al., June 22, 2018). Another recent study
found that higher influenza vaccination
rates result in both fewer deaths and
significantly reduced illness-related
work absences (White, 2021).
OSHA recognizes that absenteeism
has been a problem. However, as
explained in other sections of the
preamble, the ETS vaccination and
testing and face covering requirements
are necessary to reduce the spread of
COVID–19 in the workplace, which may
in part reduce absenteeism. The ETS
might in a limited sense also increase
absenteeism because the rule requires
employers to temporarily remove from
the workplace any employee who
receives a positive COVID–19 test or is
diagnosed with COVID–19 by a licensed
healthcare provider. However, this
provision will also help to further
reduce absenteeism because, when an
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36 This survey done in August, 2021, has 1,630
responses, reported by HR staff, attorneys, and
executives. Described as being ‘‘from a variety of
industries,’’ 83 percent of respondents were from
companies with more than 100 employees.
37 This August 2021 global survey (all results
presented here are for the US only) has 1,143
responses. It covers 28 industries, including:
Technology and Software, Business and
Professional Services, Manufacturing, Construction,
and Healthcare. Ninety percent of respondents were
from companies with more than 100 employees.
38 BLS (March 11, 2021).
39 Id.
40 Umland, October 13, 2021. This October 2021
survey has 1,059 total respondents, though only 365
have implemented a vaccination mandate and
answered this turnover question.
infected employee is promptly removed
from the workplace, that can prevent
one employee from infecting other
employees in the workplace and
potentially causing an outbreak or a
super-spreader event. Thus, OSHA
concludes that the ETS may, on net,
help ameliorate absenteeism by
reducing illnesses, but in any event will
not increase absenteeism (see OSHA,
October 2021c).
d. The Effect of Employee Turnover
One of the primary concerns among
employers in imposing vaccination
mandates is loss of staff, with 60 percent
of employers selecting it as a concern
with regard to mandating COVID–19
vaccination, according to one survey
(Mishra and Hartstein, August 23,
2021).36 To this end, employer
vaccination mandates could lead to
employee turnover; employees could
either leave on their own volition or
employers who have instituted strict
vaccination policies may fire workers
who are not vaccinated, or place them
on unpaid leave.
On the other hand, there is
countervailing evidence to suggest that
employers who implement a vaccine
mandate will be met with an influx of
potential workers. Many employees
would prefer a mandate in place, and
would be more likely to stay with, or
apply to, a firm that had a vaccine
mandate in place. For example,
although Inova health system in
Northern Virginia, lost 89 workers for
noncompliance with the system’s
vaccination mandate, that loss
amounted to less than 0.5 percent of its
workforce, (Portnoy, October 3, 2021),
and, in any event, Inova’s CEO stated
that the vaccine mandate has helped
with recruitment, and that its workers
are concerned for their own safety and
want to know they are working with
vaccinated colleagues. This same article
listed some other Virginia healthcare
systems with higher rates of loss in
connection with vaccine mandates.
Valley Health terminated 1 percent of its
employees, while Luminis Health had
about 2 percent of its workers still
unvaccinated at the time of its mandate
deadline. As another example, although
United Airlines had 593 employees (out
of the company’s 67,000 U.S.
employees) who had not complied with
the company’s vaccination mandate at
the end of September (a number that
dropped below 240 employees by
October 1), the company reported it has
received 20,000 applications for 2,000
flight attendant positions, a much
higher ratio than before the pandemic
(Chokshi and Scheiber, October 2,
2021). In addition, one survey reports
that among employee resignations due
to COVID–19 workplace policies, 42
percent reported lack of workplace
safety policies, 17 percent reported that
existing workplace policies were not
stringent enough, and only 39 percent
reported overly restrictive workplace
policies, suggesting that many
employees will welcome vaccine
mandates (ASU COVID–19 Diagnostic
Commons, October 6, 2021).37
While employee turnover is a natural
part of business in any industry, higher
employee turnover rate than normal can
have a direct impact on profit and
revenue. The normal range of employee
turnover differs widely by industry,
with an average turnover rate of about
50 percent per year overall for the
private sector.38 For example, between
2016 and 2020, employee turnover
ranged from 55 percent to 70 percent in
the retail industry and from 40 percent
to 60 percent in the transportation
industry (the industry sectors with the
highest employment).39
OSHA acknowledges that a vaccine
mandate may result in increased
employee turnover, but one recent
survey 40 suggests it is very unlikely that
this potential increase in employee
turnover will exceed the ranges that
industries have experienced over time.
The survey, though limited because
many respondents did not have
mandates in place at that time, shows
that there was no impact on turnover for
71 percent of those with mandates in
place. Only 25 percent saw a slight
increase in turnover (1 percent to 5
percent above normal) and only 4
percent saw a significant increase (more
than 5 percent above normal). As such,
OSHA does not anticipate that the
potentially increased employee turnover
attributable to vaccine mandates will be
substantial enough to negate normal
profit and revenue.
To this end, an important factor to
consider in examining turnover in
connection with vaccine mandates is
the unquantified cost savings and other
positive economic impacts accruing to
employers that institute vaccine
mandates. These include reduced
absenteeism due to fewer COVID–19
illnesses and quarantines, as discussed
above. Other positive economic impacts
of a vaccine mandate are increased retail
trade from customers that feel less at
risk and better relations with suppliers
and other business partners. These all
would contribute to improved business
and increased profits.
The existence of these cost savings
and other positive economic impacts
accruing to employers that comply with
the ETS suggests that the actual net
costs of the ETS could be much lower
than the costs reported in this section of
the economic analysis. As OSHA
discusses above, OSHA has provided
evidence to support its estimate that 25
percent of covered employers already
voluntarily require that their employees
be vaccinated and a much larger
percentage are considering a vaccine
mandate. This supports the conclusion
that these businesses agree that doing so
will ultimately save costs.
In addition, under the ETS, employers
may implement a policy that allows for
testing and face covering instead. Firms
will have a tendency to self-select: If a
large proportion of its work force has
indicated concern about a vaccine
mandate, the firm is more likely to
choose the testing option to retain their
workers. This is one factor that led the
agency to estimate that approximately
40 percent of employers will allow
employees to choose testing and face
coverings in lieu of vaccination. To the
extent employers are concerned about
employee testing costs, employers can
generally absorb testing costs or help
employees reduce those costs through
low-cost assistance such as employer
proctoring of tests (even though that is
not required by this ETS). Departure of
personnel because of vaccine mandates
is also likely to be less common when
vaccine mandates are more prevalent
across employers in a region or
industry. One survey reports that 65
percent of employers state that actions
of other companies in their industry are
very, or at least moderately, important
in deciding to mandate vaccination
(Mishra and Hartstein, August 23, 2021).
Mandatory vaccinations for COVID–
19 are still relatively new because
vaccines only became available in
quantities sufficient to support such
mandates only about 6 months ago, and
the FDA has only recently moved past
emergency clearance to final clearance.
While there is not an abundance of
evidence about whether employees have
actually left or joined an employer
based on a vaccine mandate,
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41 Two polls from June 2021, when the number
of COVID–19 cases had dropped dramatically just
before the Delta Variant led to a surge in cases,
indicated that 50% of unvaccinated employees
surveyed said that they would leave their job rather
than accept a vaccination mandate from their
employer. (KFF et al., June 30, 2021) (the same
percentage also responded that ‘‘The number of
cases is so low that there is no need for more people
to get the vaccine.’’). A separate poll from the same
time also stated that 48% of ‘‘vaccine hesitant’’
employees claimed they would quit their jobs rather
than be vaccinated. (Barry et al., September 24,
2021—citing yet unpublished June 2021 poll). In a
more recent poll, about 44% of workers said that
they would consider leaving their jobs if they were
forced to get vaccinated, while around 38% of
workers would consider leaving their current
employer if the organization did not enact a vaccine
mandate. (Kelly August 12, 2021). Interestingly, in
that survey there was a direct correlation between
the age of the worker and the desire to have a
vaccinated workplace: Younger workers, usually
the most mobile portion of the workforce, had a
much higher desire for a vaccinated workforce
(50% of Generation Z employees, as compared to
33% of Baby Boomers).
42 An article titled ‘‘Unvaccinated Workers Say
They’d Rather Quit Than Get a Shot, but Data
Suggest Otherwise’’ noted the 48%–50% threat to
leave, but included hard data showing nothing
close to those levels actually occurred: Houston
Methodist Hospital required its 25,000 workers
(including its 3,580 unvaccinated employees) to get
a vaccine by June 7, and only 153 resigned or were
fired (4% of the 3,580 unvaccinated employees;
0.6% of the total number of employees); other
examples of the numbers of employees who left in
response to their employers’ mandatory vaccine
policy involved 5 out of 527 (0.9%), 2 out of 250
(0.8%), 6 out of 260 (3%), and 125 out of 35,800
(0.3%). (Barry et al., September 24, 2021).
43 Note to paragraph (d): Under federal law,
including the Americans with Disabilities Act
(ADA) and Title VII of the Civil Rights Act of 1964,
some workers may be entitled to a reasonable
accommodation from their employer, absent undue
hardship. If the worker requesting a reasonable
accommodation cannot be vaccinated against
COVID–19 and/or wear a face covering because of
a disability, as defined by the ADA, or if the
vaccination, testing, and/or wearing a face covering
conflicts with the worker’s sincerely held religious
belief, practice or observance, the worker may be
entitled to a reasonable accommodation. For more
information about evaluating requests for these
types of reasonable accommodations for disability
or sincerely held religious belief, employers should
consult the Equal Employment Opportunity
Commission’s regulations, guidance, and technical
assistance including at: https://www.eeoc.gov/wysk/
what-you-should-know-about-covid-19-and-ada-
rehabilitation-act-and-other-eeo-laws.
particularly one with an alternative
allowing for testing in lieu of
vaccination, OSHA has examined the
best available evidence it could locate in
the timeline necessary to respond with
urgency to the grave danger addressed
in this ETS. Based on that, OSHA is
persuaded that the net effect of the
OSHA ETS on employee turnover will
be relatively small, given the option for
employers to implement a testing and
face covering policy and the
countervailing forces surrounding
turnover that will limit those effects, as
discussed above.
Finally, OSHA finds one line of
evidence particularly persuasive
because it involves data instead of polls:
While different surveys may suggest
different levels of worker intentions
(joining or remaining with a safer
employer versus leaving an employer to
avoid vaccination),41 the data suggests
that the number of employees who
actually leave an employer is much
lower than the number who claimed
they might: 1% to 3% or less actually
leave, compared to the 48–50% who
claimed they would.42 As discussed
earlier, this turnover number is well
below the average turnover rate in most
industries. Thus, OSHA concludes that
whether or not the ETS proves helpful
to recruitment efforts for some
employers, it will not, on balance, add
significant new costs to covered
employers or threaten the economic
feasibility of any industry during a six
month period.
OSHA seeks comments on these
estimates and conclusions, as well as
further data that it could use to refine
its estimates.
IV. Cost Analysis for COVID–19
Vaccination and Testing ETS,
§ 1910.501
In this section, OSHA provides
estimates of the per-entity and total
costs for the requirements of this ETS.
Section 6(c)(3) of the OSH Act states
that the Secretary will publish a final
standard ‘‘no later than six months after
publication of the emergency standard.’’
Costs are therefore estimated over a six-
month time period. Note that the
estimates are presented in this section at
the 3-digit NAICS level, but the analysis
was conducted at the 6-digit NAICS
level and aggregated to the 3-digit level
for presentation purposes. The 6-digit
NAICS level data is accessible in the
supporting spreadsheet. It should be
noted that this analysis deals strictly
with averages. For any given entity,
actual costs may be higher or lower than
the point estimate shown here, but
using an average allows OSHA to
evaluate feasibility by industry as
required by the OSH Act. In addition,
OSHA has limited data on many of the
parameters needed in this analysis and
has estimated them based on the
available data, estimates for similar
requirements for other OSHA standards,
consultation with experts in other
government agencies, and internal
agency judgment where necessary.
OSHA’s estimates are therefore based on
the best evidence available to the agency
at the time this analysis of costs and
feasibility was performed.
As mentioned above, OSHA estimates
that approximately 264,000 entities
have employees who will be subject to
the requirements of the ETS, including
approximately 84.2 million employees.
Many ETS requirements result in labor
burdens that are monetized using the
labor rates described next.
a. Wage Rates
OSHA used occupation-specific wage
rates from BLS 2020 OEWS data (BLS,
2021a). Within each affected 6-digit
NAICS industry, OSHA calculated the
employee-weighted average wage to be
used in the analysis. OSHA estimated
loaded wages using the BLS’ Employer
Cost for Employee Compensation data
(BLS, 2021b), as well as OSHA’s
standard estimate for overhead of 17
percent times the base wage.
Costs are estimated using three labor
rates for each NAICS industry: The
average labor rate for all employees, the
labor rate for General and Operations
Managers (SOC code 11–1021), and the
labor rate for Office Clerks, General
(SOC 43–9060). Industry-specific wage
rates are presented in Appendix C in the
accompanying document in the docket,
‘‘Vaccination and Testing ETS:
Economic Profile and Cost Chapter
Appendices (OSHA, October, 2021b).’’
b. Rule Familiarization, Employer
Policy on Vaccination, and Information
Provided to Employees
ETS Requirements
Section 1910.501(d)(1) of the ETS
specifies that the employer must
establish and implement a written
mandatory vaccination policy. The
employer is exempted from the
requirement in paragraph (d)(1) only if
the employer establishes and
implements a written policy allowing
any employee not subject to a
mandatory vaccination policy to either
choose to be fully vaccinated against
COVID–19 or to provide proof of regular
testing for COVID–19 in accordance
with paragraph (g) of the ETS and to
wear a face covering in accordance with
paragraph (i) of the ETS.43
In addition, under § 1910.501(j),
information provided to employees, the
ETS requires the employer to inform
each employee, in a language and at a
literacy level the employee understand
about: (1) The requirements of the ETS
as well as any employer policies and
procedures established to implement
the ETS; (2) COVID–19 vaccine efficacy,
safety, and the benefits of being
vaccinated; (3) the requirements of 29
CFR 1904.35(b)(1)(iv) and Section 11(c)
of the OSH Act; and (4) the prohibitions
of 18 U.S.C. 1001 and Section 17(g) of
the OSH Act.
As stated, the ETS face covering
requirements are contained in paragraph
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44 The estimates for the time to create the written
vaccine policy plan under this ETS may differ from
the time to create the various processes under the
CMS rule published elsewhere in this issue of the
Federal Register since the requirements of what is
needed to be included in the plans differ. For
example, the CMS plan requires a process for
ensuring the implementation of additional
precautions to mitigate the transmission and spread
of COVID–19 while OSHA’s vaccination policy
requirements do not include this requirement.
(i) of the ETS. Under that paragraph, the
employer, with certain exceptions
specified in the ETS, must ensure that
each employee who is not fully
vaccinated wears a face covering when
indoors and when occupying a vehicle
with another person for work purposes.
The ETS does not require, nor does it
prohibit, the employer to pay for any
costs associated with face coverings
(although employer payment for face
coverings may be required by other
laws, regulations, or collective
bargaining agreements or other
collectively negotiated agreements).
However, the employer must permit the
employee to wear a respirator instead of
a face covering whether required or not.
In addition, the employer may provide
respirators or face coverings to the
employee, even if not required. In such
circumstances, where the employer
provides respirators, the employer must
also comply with § 1910.504, Mini
respiratory protection program.
OSHA estimates no costs associated
with an employee voluntarily bringing
in their own respirator to use instead of
a face covering other than those costs
that OSHA is estimating below in
connection with 29 CFR 1910.501(j),
information provided to employees.
That section provides, again, that the
employer must inform each employee,
in a language and at a literacy level the
employee understands about the
requirements of the ETS as well as any
employer policies and procedures
established to implement the ETS. One
policy the employer would need to
establish to implement the ETS is a
policy to comply with the requirements
of 29 CFR 1910.504 when an employee
voluntarily brings in their own
respirator. Those requirements require
only that the employer provide certain
information to the employee (see 29
CFR 1910.504(c)).
OSHA is also estimating no costs in
connection with the employer providing
respirators to the employee. The ETS
does not require the employer to
provide respirators to employees.
Therefore, any such provision is
voluntary and not relevant to economic
feasibility of this rule.
The face covering provisions in
paragraph (i) contain several other
requirements, none of which have costs
associated with them.
Cost Analysis Assumptions
In this section, OSHA estimates the
cost for establishing the employer policy
on vaccination, providing required
information to employees, and rule
familiarization. OSHA assumes each
entity will require an average one-time
labor burden of 1 hour of management
labor for rule familiarization. OSHA
based this unit cost on that taken for
rule familiarization in the Healthcare
ETS (86 FR at 32496), but adjusted the
time downward by a half-hour because
this ETS is a simpler standard than the
Healthcare ETS.
To establish a written policy in
accordance with paragraph (d) of the
ETS, OSHA assumes a one-time average
labor burden of 5 hours of manager time
per firm. OSHA bases this estimate on
its cost estimates in the Healthcare ETS,
where OSHA estimated that
development of the COVID–19 Plan
required by that standard would take
between 5 and 40 hours (see 86 FR at
32496–32497). OSHA concludes that 5
hours is a reasonable estimate because
the development of a written policy on
vaccination will be much simpler than
the development of the written COVID–
19 Plan required by the Healthcare ETS
(see 29 CFR 1910.502(c)).44 OSHA
notes, that like the Healthcare ETS (id.),
the cost of implementing the plan for
this ETS are included in the costs of
implementing the corresponding
requirements in the ETS, which are
discussed below.
To provide information to employees
in accordance with paragraph (j) of the
ETS, OSHA assumes a one-time average
labor burden per firm of 10 minutes of
manager time. The agency expects
activities like posting the information
on a community board, mass emailing,
etc., will satisfy this requirement.
The total cost for rule familiarization,
establishing an employer policy on
vaccination and providing required
information to employees is calculated
as the product of:
• One-time labor burden for rule
familiarization and establishing a policy
(a total of 6 hours of manager time per
entity) plus a one-time labor burden for
providing information to employees (10
minutes of manager time per entity);
• The labor rate for General and
Operations Managers (SOC code 11–
1021, NAICS-specific wages); and,
• The total number of covered
entities.
Cost for Employer Policy on Vaccination
and Information Provided to Employees
Costs per entity and total costs for
employer policy on vaccination and
information provided to employees are
shown below in Table IV.B.9.
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BILLING CODE 4120–01–C
c. Determining Employee Vaccination
Status
ETS Requirements
Under § 1910.501(e):
Paragraph (e)(1). The employer must
determine the vaccination status of each
employee. This determination must
include whether the employee is fully
vaccinated, which is 2 weeks after the
full required vaccine course is
completed.
Paragraph (e)(2). The employer must
require each vaccinated employee to
provide acceptable proof of vaccination
status, including whether they are fully
or partially vaccinated. Acceptable
proof of vaccination status is:
• The record of immunization from a
health care provider or pharmacy;
• A copy of the COVID–19
Vaccination Record Card;
• A copy of medical records
documenting the vaccination;
• A copy of immunization records
from a public health, state, or tribal
immunization information system; or
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45 While there may be some administrative costs
borne by the government, such costs are not
germane to this analysis of whether the ETS is
economically feasible for covered employers.
46 Prior to the effective date of this rule, some
companies offered on-site vaccination according to
a limited survey. (Willis Towers Watson, June 23,
2021). See also CDC on creating an on-site program
(CDC, March 25, 2021; CDC, October 4, 2021b).
• A copy of any other official
documentation that contains the type of
vaccine administered, date(s) of
administration, and the name of the
health care professional(s) or clinic
site(s) administering the vaccine(s).
In instances where an employee is
unable to produce acceptable proof of
vaccination, per above, a signed and
dated statement by the employee,
subject to criminal penalties for
knowingly providing false information:
• Attesting to their vaccination status
(fully vaccinated or partially
vaccinated); and
• Attesting that they have lost and are
otherwise unable to produce proof
required by the ETS.
Paragraph (e)(3). Any employee who
does not provide one of the acceptable
forms of proof of vaccination status in
paragraph (e)(2) of the ETS to the
employer must be treated as not fully
vaccinated for the purpose of the ETS.
Paragraph (e)(4). The employer must
maintain a record of each employee’s
vaccination status and must preserve
acceptable proof of vaccination for each
employee who is fully or partially
vaccinated. The employer must
maintain a roster of each employee’s
vaccination status. These records and
roster are considered to be employee
medical records and must be
maintained as such records in
accordance with 29 CFR 1910.1020 and
must not be disclosed except as required
or authorized by the ETS or other
federal law. These records and roster are
not subject to the retention requirements
of 29 CFR 1910.1020(d)(1)(i) but must be
maintained and preserved while the
ETS remains in effect.
Paragraph (e)(5). Finally, when an
employer has ascertained employee
vaccination status prior to the effective
date of this section through another
form of attestation or proof, and retained
records of that ascertainment, the
employer is exempt from the
requirements in paragraphs (e)(1)–(e)(3)
only for each employee whose fully
vaccinated status has been documented
prior to the effective date of this section.
For purposes of paragraph (e)(4), the
employer’s records of ascertainment of
vaccination status for each such person
constitute acceptable proof of
vaccination.
The full costs for these provisions are
taken under the costs for recordkeeping,
discussed below, because determining
vaccination status, providing acceptable
proof of vaccination status, and creating
and maintaining a roster of each
employee’s vaccination status will be
part and parcel of the recordkeeping
process.
d. Employer Support for Employee
Vaccination
ETS Requirements
Under 29 CFR 1910.501(f):
The employer must support COVID–
19 vaccination by providing:
• Time for vaccination. The employer
must: (i) Provide a reasonable amount of
time to each employee for each of their
primary vaccination series dose(s); and
(ii) provide up to 4 hours paid time,
including travel time, at the employee’s
regular rate of pay for this purpose.
• Time for recovery. The employer
must provide reasonable time and paid
sick leave to recover from side effects
experienced following any primary
vaccination series dose to each
employee for each dose.
Under the ETS, fully vaccinated
means (i) a person’s status 2 weeks after
completing primary vaccination with a
COVID–19 vaccine with, if applicable,
at least the minimum recommended
interval between doses in accordance
with the approval, authorization, or
listing that is: (A) Approved or
authorized for emergency use by the
FDA; (B) listed for emergency use by the
World Health Organization (WHO); or
(C) administered as part of a clinical
trial at a U.S. site, if the recipient is
documented to have primary
vaccination with the ‘‘active’’ (not
placebo) COVID–19 vaccine candidate,
for which vaccine efficacy has been
independently confirmed (e.g., by a data
and safety monitoring board), or if the
clinical trial participant from the U.S.
site had received a COVID–19 vaccine
that is neither approved nor authorized
for use by FDA but is listed for
emergency use by WHO; or (ii) a
person’s status 2 weeks after receiving
the second dose of any combination of
two doses of a COVID–19 vaccine that
is approved or authorized by the FDA,
or listed as a two-dose series by the
WHO (i.e., heterologous primary series
of such vaccines, receiving doses of
different COVID–19 vaccines as part of
one primary series). The second dose of
the series must not be received earlier
than 17 days (21 days with a 4-day grace
period) after the first dose.
Cost Analysis Assumptions
OSHA assumes there will be no costs
to employers or employees associated
with the vaccine itself.45 However, to
provide support for vaccination of
employees, OSHA estimates that it will
take an average of 15 minutes of travel
time, each way, per employee to travel
to a vaccination site (for a total of 30
minutes). OSHA then estimates 5
minutes to wait, fill out any necessary
paperwork, and receive the shot, and a
post-shot wait time of 20 minutes, per
employee. Some firms, particularly
larger ones, will find it cheaper to have
vaccines administered on site. They
may have an on-site health clinic or may
hire a 3rd party purveyor to come to the
facility.46 This will minimize travel and
also allow the companies to mitigate
some of the logistical issues that may be
preventing employees from receiving a
vaccine (finding a convenient
appointment time, etc.). OSHA
estimates that 10 percent of firms with
employees between 100 to 500
employees will select this option, while,
given decreased average costs associated
with economies of scale, 25 percent of
firms with over 500 employees will
select this option. OSHA was unable to
obtain an estimate of the cost savings
associated with on-site vaccination in
the time allotted to issue this emergency
standard, so it is assuming that the costs
for off-site vaccination are the same as
the costs for on-site vaccination. This
results in a likely over-estimate of costs
given that the entities that choose the
on-site option will do so as a cost-saving
measure.
In OSHA’s cost analysis, OSHA
assumes that all employees will be
vaccinated during working hours and
employers would adjust the employee
work schedule to ensure that the
employee would not become eligible for
overtime pay as a result of the
vaccination time. However, it should be
noted that, if an employee chooses to
receive the vaccine outside of work
hours, OSHA does not require
employers to grant paid time to the
employee for the time spent receiving
the vaccine during non-work hours
(although other laws may include
additional requirements for employers,
such as those addressing reasonable
accommodations or exemptions).
OSHA’s analysis may be an
overestimate as it reflects an assumption
that all vaccinations are received during
work hours.
CDC data indicated that 5 percent of
employees vaccinated have received the
Johnson & Johnson vaccine, and 95
percent have received either Pfizer or
Moderna (CDC, October 2021b). OSHA
applies the same allocation to
employees being vaccinated under the
ETS. For those receiving Pfizer or
Moderna, the labor burden outlined
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47 According to the CDC, people with allergies
require a wait time of 30 minutes, but they are a
small group, and, in any event, the CDC
recommends that routine wait time is 15 minutes,
so the agency considers that its average of 20
minutes is probably an overestimate. (See CDC,
October 4, 2021a; CDC, March 3,2021.)
above occurs twice, since vaccination
requires two shots.
The employer must provide
reasonable time and paid sick leave to
recover from side effects experienced
following any vaccination dose to each
employee for each vaccination dose.
Employers may require employees to
use paid sick leave benefits otherwise
provided by the employer to offset these
costs, if available. The average amount
of time off an employee may need for
side effects while receiving the vaccine
doses necessary to achieve full
vaccination (one or two doses,
depending on the vaccine) depends on
several factors. First, the percentage of
people who will have side effects that
are severe enough to require time.
Second, the average time duration for
those who have such a severe reaction.
For estimates of these parameters OSHA
is using a recent study (Levi et al.,
September 29, 2021) which surveyed
workers at a state-wide health care
system who had been vaccinated. The
study found that, for the first dose, 4.9%
needed administrative leave, with an
average length of absence of 1.66 days.
For the second dose, 19.79% needed
leave and their average length of
absence was 1.39 days. Together, the
average time on leave is .36 days (.049
* 1.66 + .1979 * 1.39) for a person
receiving two doses, which reflects the
fact that many people who receive the
vaccine do not have any side effects for
either dose while others have more
severe side effects.
In order to determine the amount of
paid sick leave that would be available
to employees, OSHA relied on data from
BLS (BLS, 2021e). BLS estimates that for
civilian workers in establishments with
100+ employees, 88% have access to
paid sick leave (Table 33). BLS states
that the average number of paid sick
leave available is 9 days (Table 36).
Because there is the same number of
days across all levels of employee
tenure (1 year, 5 years, 10 years, and 20
years), OSHA used 9 days for all
covered employees. The agency assumes
that 75% of the available paid sick leave
has been used by the current 4th quarter
of the calendar year. So the average
number of days available is 1.98 days:
9 (days) * 88% (employees with
available paid sick leave) * 25%
(amount of leave remaining in the year)
= 1.98 days available. Given that the
average overall time out due to side
effects is 0.36 days (see above), OSHA
concludes that, on average, employees
should have sufficient existing paid sick
leave available to cover the time needed
as a result of vaccine-related side
effects. As a result, OSHA is taking no
costs to employers in connection with
the ETS’s requirement to provide time
for recovery from vaccination (except as
provided below), as these costs will
have been incurred by the employer
independent of the ETS.
While this analysis is entirely
consistent with OSHA’s standard
procedure of strictly using averages in
cost analysis, it nonetheless masks some
significant effects resulting from the
time for recovery requirements. From
the BLS data, OSHA knows there are
12% of establishments that have 100+
employees and do not provide paid sick
leave. Correspondingly, there is a group
of entities with no paid sick leave that
will obviously incur costs that result
directly from these requirements. In
addition, some employees may not
have, or some other entities may not
offer, sufficient paid sick leave to cover
these costs.
To account for the 12 percent of firms
that do not offer paid sick leave, the
agency uses the above estimate of
average days for two doses, 0.36 days,
and multiplies the average employee
wage by NAICS to calculate the cost per
employee. Since OSHA does not know
which firms make up the 12 percent, the
agency spreads this total cost across all
firms by employee. Since firms without
any sick leave are likely to be lower-
wage firms, this will likely lead to a cost
overestimate.
Therefore, the total cost for paid time
off for vaccination is based on the costs
for providing paid sick leave for the 12
percent of firms that do not offer paid
sick leave and:
• Travel time per employee of
covered firms of 15 minutes each way
per vaccination dose (total of 30
minutes).
• Pre-shot wait time per employee of
covered firms of 5 minutes per
vaccination dose.
• Post-shot wait time per employee of
covered firms of 20 minutes per
vaccination dose.47
• The average labor rate for
employees (NAICS-specific wages).
• Total number of employees at
covered firms getting vaccinated due to
the ETS with the Johnson & Johnson
vaccine.
• Total number of employees at
covered firms getting vaccinated due to
the ETS with the Pfizer and Moderna
vaccines, multiplied by two to account
for two shots.
Cost for Support for Employee
Vaccination
Costs per firm and total costs for
vaccination are shown below in Table
IV.B.10.
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48 OSHA notes that while the testing required
under this standard might be an option for
employees who request a reasonable
accommodation to avoid vaccination, other
alternatives such as telework would be more
protective to the employee by preventing COVID–
19 exposure. These alternatives may also be
available at no additional cost to the employer or
employee.
BILLING CODE 4120–01–C
e. COVID–19 Testing for Employees
Who Are Not Fully Vaccinated
ETS Requirements
Section 1910.501(g)(1) of the ETS
requires the employer to ensure that
each employee who is not fully
vaccinated do the following:
An employee who reports at least
once every 7 days to a workplace where
other individuals, such as coworkers or
customers, are present:
• Must be tested for COVID–19 at
least once every 7 days; and
• Must provide documentation of the
most recent COVID–19 test result to the
employer no later than the 7th day
following the date on which the
employee last provided a test result.
An employee who does not report
during a period of 7 or more days to a
workplace where other individuals,
such as coworkers or customers, are
present (e.g., teleworking for two weeks
prior to reporting to a workplace with
others):
• Must be tested for COVID–19
within 7 days prior to returning to the
workplace; and
• Must provide documentation of that
test result to the employer upon return
to the workplace.
Furthermore, if an employee does not
provide documentation of a COVID–19
test result as required by paragraph
(g)(1) of the ETS, the employer must
keep that employee removed from the
workplace until they provide a test
result. In addition, when an employee
has received a positive COVID–19 test,
or has been diagnosed with COVID–19
by a licensed healthcare provider, the
employer must not require that
employee to undergo COVID–19 testing
as required under paragraph (g) of this
section for 90 days following the date of
their positive test or diagnosis. Finally,
the employer must maintain a record of
each test result provided by each
employee under paragraph (g)(1) of this
section or obtained during tests
conducted by the employer. These
records are considered to be employee
medical records and must be
maintained as such records in
accordance with 29 CFR 1910.1020 and
must not be disclosed except as required
or authorized by this section or other
federal law. These records are not
subject to the retention requirements of
29 CFR 1910.1020(d)(1)(i) but must be
maintained and preserved while this
section remains in effect.
OSHA addresses the costs associated
with testing in the next section. The
remaining costs required by paragraph
(g) are taken under the costs for
recordkeeping, discussed below,
because providing documentation of test
results to the employer will be part and
parcel of the recordkeeping process.
Employees who are partially
vaccinated are also required to be tested
weekly until they are fully vaccinated.
Those receiving the J&J vaccine will
require two weeks of testing after the
single shot, employees who received the
Pfizer-BioNTech Vaccine will require 5
weeks of testing (3 weeks between shots
and 2 weeks following the second shot),
and Moderna recipients require 6 weeks
of testing (4 weeks between shots and 2
weeks following the second shot) (CDC,
October 4, 2021b). Notwithstanding this,
in the agency’s total cost estimate OSHA
accounts for the fact that employers
need not comply with the requirements
of this section in paragraph (g) by 60
days after the rule’s effective date, and
that employees who have completed the
entire primary vaccination series by that
date do not have to be tested, even if
they have not yet completed the 2 week
waiting period.
There is no requirement in the rule
that the employer pay for this testing so
these testing-related costs are not
included in the main analysis (although,
as discussed below OSHA takes into
account costs for testing in connection
with the ETS’s recordkeeping
requirements). The agency estimates
that 6.3 million weekly tests will need
to be given due to this ETS (see Table
IV.B.8). This 6.3 million is likely an
overestimate of new costs because it
encompasses tests for employees who
were already required to conduct testing
by their employers prior to this ETS.
OSHA also notes that its cost
estimates for testing do not take into
account the 90-day break in testing that
occurs following the date of a positive
test or diagnosis. OSHA’s cost estimates
are also potentially overcounting costs
in that OSHA does not take into account
that not all employees for whom testing
is required will report at least once
every 7 days to a workplace where other
individuals, such as coworkers or
customers, are present. Thus, OSHA’s
estimate assumes that employees for
whom testing is required will need to be
tested at least once every 7 days and not
less frequently as will often be the case.
OSHA notes, in addition, that there
are no costs associated with paragraph
(g)’s removal provision. The ETS does
not require the employer to provide
paid time off to any employee for
removal as a result of the employee’s
refusal/failure to provide
documentation of a COVID–19 test
result as required by paragraph (g)(1) of
the ETS.
Finally, OSHA notes that a COVID–19
test under the ETS is a test for SARS–
CoV–2 that is: (i) Cleared, approved, or
authorized, including in an Emergency
Use Authorization (EUA), by the FDA to
detect current infection with the SARS–
CoV–2 virus (e.g., a viral test); (ii)
Administered in accordance with the
authorized instructions; and (iii) Not
both self-administered and self-read
unless observed by the employer or an
authorized telehealth proctor. Examples
of tests that satisfy this requirement
include tests with specimens that are
processed by a laboratory (including
home or on-site collected specimens
which are processed either individually
or as pooled specimens), proctored over-
the-counter tests, point of care tests, and
tests where specimen collection and
processing is either done or observed by
an employer. Employers may have costs
associated with doing, observing or
proctoring employee testing, if
employers choose to do so. However, for
economic feasibility purposes, OSHA
does not account for these costs in its
estimates because they are not required
for compliance with the ETS.
Costs Associated with Reasonable
Accommodation: Testing, Face
Coverings, and Determinations
The ETS does not require the
employer to pay for any costs associated
with testing; however employer
payment for testing may be required by
other laws, regulations, or collective
bargaining agreements. Thus, while
OSHA does not include any costs for
reasonable accommodation requests in
its main cost analysis in recognition that
such costs would result from the
application of other laws, OSHA notes
that even if employers were to agree to
pay for COVID–19 testing as part of a
reasonable accommodation or some
other reason required by law, such costs
would not alter OSHA’s findings
regarding the economic feasibility of the
rule.48 OSHA reached this conclusion
after conducting a separate analysis of
reasonable accommodation costs that an
employer might assume if they do not
represent an undue hardship for the
employer. This analysis is available in
the docket at OSHA, October 2021d.
OSHA notes that this separate
analysis is limited to employees who
request accommodation, and accounts
for costs of reviewing medical and/or
religious accommodation requests, as
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49 These counts represent hospitalizations and
fatalities that would occur to the in-scope labor
force despite the ETS. The numbers are derived
using methodology similar to that used in Health
Impacts to generate hospitalizations and fatalities
prevented. An infection rate and case fatality rate
are multiplied by the number of unvaccinated
workers to derive a total number of fatalities. That
number is used to derive hospitalizations. The
number of hospitalizations and fatalities to
vaccinated employees is calculated in a similar
fashion, but with a lower infection rate because
vaccination makes it considerably less likely that an
individual will be tested and found to be infected.
See (OSHA, October 2021a and OSHA, October
2021c). One difference in methodology between
these counts and the Health Impacts analysis is that
these counts use a baseline of the last 19 months
of CDC data to estimate the case fatality rate (similar
to Alternative C in the Health Impacts analysis),
rather than a baseline of the last 6 months (which
OSHA used for the main Health Impacts analysis).
This results in an estimate toward the upper bound
for these counts (i.e., an overestimate of costs).
well as costs for COVID–19 testing and
face coverings that would satisfy the
requirements of this ETS. OSHA expects
a reasonable accommodation request
could lead to a review of the employee’s
request by a manager and then a
conference between the manager and
the employee. OSHA concludes that the
combination of these costs would not
alter OSHA’s findings regarding the
economic feasibility of the ETS.
f. Employee Notification to Employer of
a Positive COVID–19 Test and Removal
ETS Requirements
Under § 1910.501(h):
Regardless of COVID–19 vaccination
status or any COVID–19 testing required
under paragraph (g) of the ETS, the
employer must:
• Require each employee to promptly
notify the employer when they receive
a positive COVID–19 test or are
diagnosed with COVID–19 by a licensed
healthcare provider; and
• Immediately remove from the
workplace any employee who receives a
positive COVID–19 test or is diagnosed
with COVID–19 by a licensed healthcare
provider and keep the employee
removed until the employee: (i)
Receives a negative result on a COVID–
19 nucleic acid amplification test
(NAAT) following a positive result on a
COVID–19 antigen test if the employee
chooses to seek a NAAT test for
confirmatory testing; (ii) meets the
return to work criteria in CDC’s
‘‘Isolation Guidance’’ (incorporated by
reference, § 1910.509); or (iii) receives a
recommendation to return to work from
a licensed healthcare provider.
Costs Analysis Assumptions
The ETS does not require employers
to provide paid time off to any
employee for removal from the
workplace as a result of a positive
COVID–19 test or diagnosis of COVID–
19; however paid time off may be
required by other laws, regulations, or
collective bargaining agreements or
other collectively negotiated
agreements. Therefore, there are no
costs associated with paragraph (h)’s
removal provision.
With respect to notification, to the
extent employee notification is
connected to the ETS’s testing and
documentation requirements in
paragraph (g), those costs to the
employer are taken under the costs for
recordkeeping, discussed below,
because, as explained above, receiving
documentation of test results under
paragraph (g) will be part and parcel of
the recordkeeping process.
OSHA notes also that the costs
associated with employee notification
by vaccinated employees (not required
by this ETS to undergo testing) should
also be negligible because it will not
occur with any real frequency. The very
low breakthrough rates of infection
among vaccinated persons suggests that
the overwhelming majority of COVID–
19 cases reported to a covered employer
will be in the pool of unvaccinated
employees.
g. Reporting COVID–19 Fatalities and
Hospitalizations to OSHA
ETS Requirements
Under § 1910.501(j):
The employer must report to OSHA:
• Each work-related COVID–19
fatality within 8 hours of the employer
learning about the fatality.
• Each work-related COVID–19 in-
patient hospitalization within 24 hours
of the employer learning about the in-
patient hospitalization.
When reporting COVID–19 fatalities
and in-patient hospitalizations to OSHA
in accordance with paragraph (j)(1) of
the ETS, the employer must follow the
requirements in 29 CFR part 1904.39,
except for 29 CFR part 1904.39(a)(1) and
(2) and (b)(6).
Cost Analysis Assumptions
OSHA estimates a total of 1,464
fatalities and 59,570 hospitalizations for
employees of covered firms.49 This
analysis is broadly consistent, using
updated data, with OSHA’s analysis of
a nearly identical provision in 29 CFR
1910.502, the Healthcare ETS. OSHA
also estimates, based on the Healthcare
ETS, that reporting of each fatality and
hospitalization will require 45 minutes
of an employer’s time (86 FR at 32516).
This includes hospitalizations and
fatalities for employees that remain
unvaccinated, as well as a small
percentage of hospitalizations and
fatalities of vaccinated employees due to
breakthrough cases. Because of the
timing requirements in the rule, the
agency assumes that a hospitalization
followed by a death will need two
reports from the employer (i.e., the
agency assumes that reporting for
hospitalizations will occur within 8
hours, before reporting for fatalities
occurs, within 24 hours). This will
result in a slight over-estimate.
The total cost for reporting COVID–19
fatalities and hospitalizations to OSHA
is calculated as the product of:
• One-time labor burden of 45
minutes per report of hospitalization or
fatality.
• Wage range for General and
Operations Managers (SOC code 11–
1021, NAICS-specific wages).
• Total number of fatalities for
employees at covered firms.
• Total number of hospitalizations for
employees at covered firms.
Cost for Reporting COVID–19 Fatalities
and Hospitalizations to OSHA
Costs per entity and total costs for
vaccination are shown below in Table
IV.B.11.
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h. Recordkeeping
ETS Requirements
As discussed above, the full costs for
the requirements in paragraph (e) of the
ETS are taken under the costs for
recordkeeping because determining
vaccination status, providing acceptable
proof of vaccination status, and creating
and maintaining a roster of each
employee’s vaccination status will be
part and parcel of the recordkeeping
process. Under paragraph (e)(4) of the
ETS, the employer must maintain a
record of each employee’s vaccination
status and must preserve acceptable
proof of vaccination for each employee
who is fully or partially vaccinated. The
employer must also maintain a roster of
each employee’s vaccination status.
These records and roster are considered
to be employee medical records and
must be maintained in accordance with
29 CFR 1910.1020 as such records and
must not be disclosed except as required
or authorized by the ETS or other
federal law. These records and roster are
not subject to the retention requirements
of 29 CFR 1910.1020(d)(1)(i) but must be
maintained and preserved while the
ETS remains in effect.
With respect to vaccination, it should
be noted that, under paragraph (e)(5) of
the ETS, when an employer has
ascertained employee vaccination status
prior to the effective date of this section
through another form of attestation or
proof, and retained records of that
ascertainment, the employer is exempt
from the determination of vaccination
requirements in paragraphs (e)(1)–(e)(3)
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50 The cost of providing to the Assistant Secretary
for examination and copying the employer’s written
policy required by paragraph (d) of the ETS will be
de minimis.
only for each employee whose fully
vaccinated status has been documented
prior to the effective date of this section.
For purposes of the recordkeeping
requirements in paragraph (e)(4), the
employer’s records of ascertainment of
vaccination status for each such person
constitute acceptable proof of
vaccination. OSHA estimates, based on
this provision, that 60% of employees
who were vaccinated prior to the
promulgation of the ETS will not need
to document vaccination status in
connection with paragraph (e) (ASU
COVID–19 Diagnostic Commons,
October 6, 2021).
As also discussed above, the costs for
the requirements for documenting test
results in paragraph (g), including the
timing for when recordkeeping costs for
testing accrue under the ETS, are taken
under the costs for recordkeeping
because providing documentation of test
results to the employer will be part and
parcel of the recordkeeping process.
Under paragraph (g)(4) of the ETS, the
employer must maintain a record of
each test result provided by each
employee under paragraph (g)(1) of the
ETS or obtained during tests conducted
by the employer. These records must be
maintained in accordance with 29 CFR
1910.1020 and must not be disclosed
except as required or authorized by this
section or other federal law. These
records are not subject to the retention
requirements of 29 CFR
1910.1020(d)(1)(i) but must be
maintained and preserved while this
section remains in effect.
With respect to testing, it should be
noted that, under paragraph (m) of the
ETS, employers are not required to
comply with the requirements in
paragraph (g) of the ETS until 60 days
after the effective date of the ETS,
meaning that for cost analysis purposes
OSHA assumes that employers would
not receive any testing records until the
end of that 60-day period.
Finally, under paragraph
1910.501(l)(1) of the ETS, availability of
records, by the end of the next business
day after a request, the employer must
make available, for examination and
copying, the individual COVID–19
vaccine documentation and any
COVID–19 test results for a particular
employee to that employee and to
anyone having written authorized
consent of that employee. In addition,
under paragraph 1910.501(l)(2) of the
ETS, by the end of the next business day
after a request by an employee or an
employee representative, the employer
must make available to the requester the
aggregate number of fully vaccinated
employees at a workplace along with
the total number of employees at that
workplace. Under paragraph
1910.501(l)(3) of the ETS, the employer
must also provide to the Assistant
Secretary for examination and copying:
(i) Within 4 business hours of a request,
the employer’s written policy required
by paragraph (d) of the ETS, and the
aggregate numbers described in
paragraph (l)(2) of the ETS; and (ii) By
the end of the next business day after a
request, all other records and other
documents required to be maintained by
the ETS.
Cost Analysis Assumptions
To fulfill the recordkeeping
requirements in the ETS, OSHA
estimates that it will take an average of
5 minutes of clerical time per employee
record. OSHA bases this cost estimate
on the estimate for recordkeeping in the
Healthcare ETS (86 FR at 32515). While
OSHA estimated an average of 10
minutes of clerical time per employee
record in the Healthcare ETS, that
standard includes more extensive
recordkeeping requirements than what
is being required under this ETS. See 29
CFR 1910.502(q)(2)(ii) (Healthcare ETS
record must contain, for each instance,
the employee’s name, one form of
contact information, occupation,
location where the employee worked,
the date of the employee’s last day at the
workplace, the date of the positive test
for, or diagnosis of, COVID–19, and the
date the employee first had one or more
COVID–19 symptoms, if any were
experienced).
In addition, OSHA includes in this
estimate 5 minutes of employee time to
provide documentation of vaccination
status or testing, as applicable, to the
employer. OSHA notes that, for an
employee who is vaccinated, the
employer will determine the
vaccination status of that employees and
obtain acceptable proof of vaccination
status at the same time, thus negating
the need to create two separate records
for these requirements.
OSHA notes that there will be a cost
associated with setting up the
recordkeeping system (e.g., a
spreadsheet) used to comply with the
ETS. OSHA takes these costs in
connection with the costs for the
employer policy on vaccination, which
are described above.
Given the relative complexity of
recordkeeping in the Healthcare ETS,
OSHA has simplified its assumptions to
reflect a variety of small costs in a
combined estimate. As in the Healthcare
ETS, the cost estimate of 5 minutes per
event is likely much higher than
necessary to account for just the actions
of receiving and maintaining copies of
records, so retaining this time will yield
a tendency toward overestimation.
However, this cost also reflects a margin
to encompass additional outlier costs
such as a second documentation of
vaccination status for all employees
who need to submit documentation
twice (first for partial vaccination and
then for full vaccination) under the ETS.
This 5 minutes for recordkeeping also
encompasses the marginal time for
creating and maintaining a roster of
each employee’s vaccination status
(paragraph (e)) and making aggregate
employee data available (paragraph (l)).
Since normally the system used for
recordkeeping will be electronic in
businesses with more than 100
employees, the time to create an
aggregate report and a roster should be
de minimis. Finally, this inflated
recordkeeping cost encompasses time
for employee notification to the
employer of a positive COVID–19 test
connected to the ETS’s testing and
documentation requirements in
paragraph (g),which is a notification
under paragraph (h). Finally, the burden
of making available, for examination
and copying, the individual COVID–19
vaccine documentation and any
COVID–19 test results for a particular
employee are included in this estimate
because this documentation will
normally be pulled from the electronic
recordkeeping system described
above.50
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The total cost for these requirements
is calculated based on:
• One-time labor burden of 5 minutes
of employee labor to provide
documentation and 5 minutes of clerk
labor per employee record (one record
per test administered and one record per
documentation of vaccination status).
• The average labor rate for Office
Clerks, General (SOC 43–9060, NAICS-
specific wages) and employees
providing documentation (average wage
over all employees, NAICS-specific
wages)
• Total number of employees at
covered firms getting vaccinated due to
the ETS with the Johnson & Johnson
vaccine, who receive one shot.
• Total number of employees at
covered firms getting vaccinated due to
the ETS with the Pfizer-BioNTech and
Moderna vaccines, multiplied by two to
account for two shots.
• Total number of tests for employees
at covered firms who are unvaccinated
and will get vaccinated by receiving the
Johnson and Johnson vaccine.
• Total number of tests for employees
at covered firms who are unvaccinated
and will get vaccinated by receiving the
Pfizer and Moderna vaccines.
• Total number of employees at
covered firms who are unvaccinated and
will be tested weekly.
Cost for Recordkeeping
Costs per entity and total costs for
recordkeeping are shown below in Table
IV.B.12.
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i. Summary of Total Cost
Total Cost and Total Cost per Entity
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j. Sensitivity Analysis
As stated above, based on limited data
on current vaccine mandate
implementation and forecasts for future
implementation (Mishra and Hartstein,
August 23, 2021; ASU COVID–19
Diagnostic Commons, October 6, 2021),
OSHA estimates that 25 percent of firms
in scope currently have a vaccination
mandate, and assumes that this will rise
to 60 percent of covered employers after
the ETS is in place. Because the agency
has no historic reference on which to
base its assumptions regarding vaccine
mandates, the agency adjusted the
percentage of firms that will institute a
vaccine mandate because of the ETS as
part of a sensitivity analysis. Along with
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the baseline estimate of 60 percent of
firms having a mandate, the agency
looked at a vaccine mandate rate of 40
percent and 80 percent for covered
firms, which OSHA judged to be a
reasonable range based on the data
available. The total costs associated
with a 40 percent vaccine mandate are
$2.998 billion, and the total costs
associated with an 80 percent vaccine
mandate are $2.964 billion. This
compares to the baseline costs
associated with a 60 percent vaccine
mandate of $2.981 billion. A higher
vaccine mandate increases the share of
employees who get vaccinated while
reducing the share that must get weekly
testing. It is this shift in shares that
causes the costs to change because the
total costs associated with weekly
testing (recordkeeping) are more
expensive than the total costs associated
with vaccination under the ETS
(employer support for vaccination,
recordkeeping).
References
ASU COVID–19 Diagnostic Commons. (2021,
October 6). https://chs.asu.edu/
diagnostics-commons/workplace-
commons. (ASU COVID–19 Diagnostic
Commons, October 6, 2021)
Barrero J et al. (2021, April). Why Working
From Home Will Stick. Becker Friedman
Institute Working Paper No. 2020–174.
https://bfi.uchicago.edu/wp-content/
uploads/2020/12/BFI_WP_2020174.pdf.
(Barrero et al., April 2021)
Barry J et al. (2021, September 24).
Unvaccinated Workers Say They’d
Rather Quit Than Get a Shot, but Data
Suggest Otherwise. Scientific American.
https://www.scientificamerican.com/
article/unvaccinated-workers-say-theyd-
rather-quit-than-get-a-shot-but-data-
suggest-otherwise/. (Barry et al.,
September 24, 2021)
Bick A et al. (2021, February). Work from
Home Before and After the COVID–19
Outbreak. Federal Reserve Bank of Dallas
No. 2017, Revised February 2021.
https://doi.org/10.24149/wp2017r2.
(Bick et al., February 2021)
Brynjolfsson E et al. (2020, June). COVID–19
and Remote Work: An Early Look At US
Data. National Bureau of Economic
Research. https://www.nber.org/system/
files/working_papers/w27344/
w27344.pdf. (Brynjolfsson et al., June
2020)
Bureau of Labor Statistics (BLS). (2017).
Quarterly Census of Employment and
Wages (QCEW). https://www.bls.gov/
cew/. (BLS, 2017)
Bureau of Labor Statistics (BLS). (2020).
Occupational Requirements Survey
(ORS). https://www.bls.gov/ors/. (BLS,
2020)
Bureau of Labor Statistics (BLS). (2021a).
Occupational Employment and Wage
Statistics (OEWS) Survey, May 2020.
https://www.bls.gov/oes/. (BLS, 2021a)
Bureau of Labor Statistics (BLS). (2021b).
Employer Costs for Employee
Compensation by Ownership, All 2018
Civilian Wages and Salaries, March
2021. https://www.bls.gov/news.release/
archives/ecec_06172021.pdf. (BLS,
2021b)
Bureau of Labor Statistics (BLS). (2021c).
Current Population Survey, Table 2.
Employed persons who teleworked or
worked at home for pay at any time in
the last 4 weeks because of the
coronavirus pandemic by usual full- or
part-time status, occupation, industry,
and class of worker; Persons who
teleworked because of the coronavirus
pandemic. https://www.bls.gov/cps/
effects-of-the-coronavirus-covid-19-
pandemic.htm#data. (BLS, 2021c)
Bureau of Labor Statistics (BLS). (2021d).
Current Population Survey, Household
Data, Annual Averages, Employment
status of the civilian noninstitutional
population by age, sex, and race, Civilian
noninstitutional population. https://
www.bls.gov/cps/cpsaat03.htm. (BLS,
2021d)
Bureau of Labor Statistics (BLS). (2021e).
National Compensation Survey:
Employee Benefits in the United States,
March 2021. https://www.bls.gov/ncs/
ebs/benefits/2021/employee-benefits-in-
the-united-states-march-2021.pdf. (BLS,
2021e)
Centers for Disease Control and Prevention
(CDC). (2021, March 3). Interim
Considerations: Preparing for the
Potential Management of Anaphylaxis
after COVID–19 Vaccination. https://
www.cdc.gov/vaccines/covid-19/clinical-
considerations/managing-
anaphylaxis.html. (CDC, March 3, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, March 25). Workplace
Vaccination Program. https://
www.cdc.gov/coronavirus/2019-ncov/
vaccines/recommendations/
essentialworker/workplace-vaccination-
program.html. (CDC, March 25, 2021)
Centers for Disease Control and Prevention
(CDC). (2021a, October). Trends in
COVID–19 Vaccine Confidence in the
US. https://covid.cdc.gov/covid-data-
tracker/#vaccine-confidence. (CDC,
October 2021a)
Centers for Disease Control and Prevention
(CDC). (2021b, October). COVID–19
Vaccinations in the United States.
https://covid.cdc.gov/covid-data-tracker/
#vaccinations_vacc-total-admin-rate-
total. (CDC, October 2021b)
Centers for Disease Control and Prevention
(CDC). (2021a, October 4). Demographic
Characteristics of People Receiving
COVID–19 Vaccinations in the United
States. https://covid.cdc.gov/covid-data-
tracker/#vaccination-demographic.
(CDC, October 4, 2021a)
Center for Disease Control and Prevention
(CDC). (2021b, October 4). COVID–19
Vaccines That Require 2 Shots. https://
www.cdc.gov/coronavirus/2019-ncov/
vaccines/second-shot.html. (CDC,
October 4, 2021b)
Cerullo M. (2021, August 31). The New
Return Office Date for Google? Try 2022.
CBS News. https://www.cbsnews.com/
news/return-to-office-big-companies-
corporations-covid-pandemic/. (Cerullo,
August 31, 2021)
Chesto J. (2021, June 22). Almost 40 percent
of remote workers in Mass. won’t be back
in the office until January, at the earliest.
Boston Globe. https://
www.bostonglobe.com/2021/06/22/
business/back-office-not-so-fast/.
(Chesto, June 22, 2021)
Chokshi N and Scheiber N. (2021, October 2).
Inside United Airlines’ Decision to
Mandate Coronavirus Vaccines. The New
York Times. https://www.nytimes.com/
2021/10/02/business/united-airlines-
coronavirus-vaccine-mandate.html.
(Chokshi and Scheiber, October 2, 2021)
Courtney E. (2021, September 27). 30
Companies Switching to Long-Term
Remote Work. flexjobs. https://
www.flexjobs.com/blog/post/companies-
switching-remote-work-long-term/.
Accessed September 27, 2021. (Courtney,
September 27, 2021).
Dingel J and Neiman B. (2020, July). How
many jobs can be done at home? Journal
of Public Economics. Volume 189, July
2020, 104235. https://
www.sciencedirect.com/science/article/
pii/S0047272720300992. (Dingel and
Neiman, July 2020)
Graham R. (2021, September 15). Vaccine
Resistors Seek Exemptions. But What
Counts as Religious? The New York
Times. https://www.nytimes.com/2021/
09/11/us/covid-vaccine-religion-
exemption.html. (Graham, September 15,
2021)
Groenewold M et al., (2020, July 10).
Increases in Health-Related Workplace
Absenteeism Among Workers in
Essential Critical Infrastructure
Occupations During the COVID–19
Pandemic—United States, March–April
2020. Centers for Disease Control and
Prevention MMWR Vol. 69, No. 27.
https://www.cdc.gov/mmwr/volumes/69/
wr/mm6927a1.htm. (Groenewold et al.,
July 10, 2020)
Kaiser Family Foundation (KFF). (2021, June
30). KFF COVID–19 Vaccine Monitor:
June 2021. https://www.kff.org/
coronavirus-covid-19/poll-finding/kff-
covid-19-vaccine-monitor-june-2021/.
(KFF, June 30, 2021)
Kelly J. (2021, August 12) Study Shows That
44% Of Employees Would Quit If
Ordered To Get Vaccinated. https://
www.forbes.com/sites/jackkelly/2021/08/
12/study-shows-that-44-of-employees-
would-quit-if-ordered-to-get-vaccinated/.
(Kelly, August 12, 2021)
KEZI News. (2021, September 25). Here’s
How Many Oregon State Employees
Have Requested a COVID Vaccine
Exemption. https://www.kezi.com/
content/news/Heres-how-many-Oregon-
state-employees-have-requested-a-
COVID-vaccine-exemption-
575395141.html. (KEZI News, September
25, 2021)
Kuhn P and Yu L. (2021, April). How Costly
is Turnover? Evidence from Retail.
Journal of Labor Economics 39(2), 461–
496. https://doi.org/10.1086/710359.
(Kuhn and Yu, April, 2021)
Lazer D et al. (2021, August 16). The COVID
States Project: A 50-State Survey, Report
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51 These results are presented in the Excel ETS
Revenue Threshold Test Tables available in the
Docket for this ETS. The data used for six-digit
NAICS were from the Bureau of the Census,
available every five years (2002, 2007, 2012, 2107).
#62: COVID–19 Vaccine Attitudes
Among Healthcare Workers. The COVID
States Project Report 62. https://
covidstates.org/reports. (Lazer et al.,
August 16, 2021)
Levi M et al. (2021, September 29). COVID–
19 mRNA vaccination, reactogenicity,
work-related absences and the impact on
operating room staffing: A cross-
sectional study. https://
www.ncbi.nlm.nih.gov/pmc/articles/
PMC8479312/. (Levi et al., September 29,
2021).
Mishra D and Hartstein B. (2021, August 23).
Littler COVID–19 Vaccine Employer
Survey Report—Delta Variant Update.
https://www.littler.com/publication-
press/press/littler-survey-employers-
increasingly-consider-vaccine-mandates-
covid-19. (Mishra and Hartstein, August
23, 2021)
National Agricultural Statistics Service
(NASS). (2017). Census of Agriculture.
https://www.nass.usda.gov/Quick_Stats/
CDQT/chapter/1/table/1. (NASS, 2017)
O’Sullivan J. (2021, September 18).
Washington state workers are getting
exemptions to avoid the COVID–19
vaccine—but will they keep their jobs?
Seattle Times. https://
www.seattletimes.com/seattle-news/
politics/washington-state-workers-are-
getting-exemptions-to-avoid-the-covid-
19-vaccine-but-will-they-keep-their-jobs/.
(O’Sullivan, September 18, 2021).
Occupational Safety and Health
Administration (OSHA). (2021,
September 25). State Plans. https://
www.osha.gov/stateplans/faqs. (OSHA,
September 25, 2021)
Occupational Safety and Health
Administration (OSHA). (2021a,
October). Analytical Spreadsheets in
Support of the COVID–19 Vaccination
and Testing ETS. (OSHA, October 2021a)
Occupational Safety and Health
Administration (OSHA). (2021b,
October). COVID–19 Vaccination and
Testing ETS: Economic Profile and Cost
Chapter Appendices. (OSHA, October
2021b)
Occupational Safety and Health
Administration (OSHA). (2021c,
October). Health Impacts of the COVID–
19 Vaccination and Testing ETS. (OSHA,
October 2021c)
Occupational Safety and Health
Administration (OSHA). (2021d,
October). Costs Associated with
Reasonable Accommodation: Testing,
Face Coverings, and Determinations.
(OSHA, October 2021d)
Portnoy J. (2021, October, 3). Several
hundred Virginia health-care workers
have been suspended or fired over
coronavirus vaccine mandates. The
Washington Post. https://
www.washingtonpost.com/local/covid-
vaccine-mandate-hospitals-virginia/
2021/10/01/b7976d16-21ff-11ec-8200-
5e3fd4c49f5e_story.html. (Portnoy,
October 3, 2021)
Putri W et al. (2018, June, 22). Economic
burden of seasonal influenza in the
United States. Vaccine 36(27), 3960–
3966. https://www.sciencedirect.com/
science/article/pii/S0264410X18306777?
via%3Dihub. (Putri et al., June 22, 2018)
Umland B. (2021, October 13). Survey Looks
at Vaccine Mandates and Employee
Turnover. Mercer. https://
www.mercer.us/our-thinking/healthcare/
survey-looks-at-vaccine-mandates-and-
employee-turnover.html. (Umland,
October 13, 2021)
U.S. Census Bureau. (2019). Statistics of U.S.
Businesses (SUSB). https://
www.census.gov/programs-survey/
susb.html. (U.S. Census Bureau, 2019)
U.S. Census Bureau. (2021). Household Pulse
Survey (HPS), Week 37 Table 6A.
https://www.census.gov/programs-
surveys/household-pulse-survey/
data.html. (U.S. Census Bureau, 2021)
White C. (2021). Measuring Social and
Externality Benefits of Influenza
Vaccination. Journal of Human
Resources Vol 56 Number 3, pp. 749–
785. https://muse.jhu.edu/article/
798143. (White, 2021)
Willis Towers Watson. (2021, June 23).
COVID–19 Vaccination and Reopening
the Workplace Survey. https://
www.willistowerswatson.com/en-US/
Insights/2021/06/covid-19-vaccination-
and-reopening-the-workplace-survey.
(Willis Towers Watson, June 23, 2021)
V. ETS Economic Feasibility
Determination
a. OSHA’s Screening Tests for Economic
Feasibility
As noted in the introduction to the
economic analysis, an OSHA standard is
economically feasible when industries
can absorb or pass on the costs of
compliance without threatening
industry’s long-term profitability or
competitive structure, Cotton Dust, 452
U.S. at 530 n.55, or ‘‘threaten[ing]
massive dislocation to, or imperil[ing]
the existence of, the industry.’’ United
Steelworkers of Am. v. Marshall (Lead
I), 647 F.2d 1189, 1272 (D.C. Cir. 1981).
To determine whether a rule is
economically feasible, OSHA typically
begins by using two screening tests to
determine whether the costs of the rule
are beneath the threshold level at which
the economic feasibility of an affected
industry might be threatened. The first
screening test is a revenue test. While
there is no hard and fast rule on which
to base the threshold, OSHA generally
considers a standard to be economically
feasible for an affected industry when
the annualized costs of compliance are
less than one percent of annual
revenues. The one-percent revenue
threshold is intentionally set at a low
level so that OSHA can confidently
assert that the rule is economically
feasible for industries that are below the
threshold (i.e., industries for which the
costs of compliance are less than one
percent of annual revenues). To put the
one-percent threshold into perspective,
OSHA calculated the average
compounded annual rate of growth or
decay in average revenues over the 15-
year period from 2002 to 2017 (inflated
to 2005 to 2020 dollars) for firms with
100 or more employees in the 479
NAICS (out of 546) industries covered
by this ETS for which Census data were
available and found that the average
annual real rate of change in revenues
in absolute terms for the average firm
was 2.2 percentage points a year.51 In
other words, revenues are generally
observed to change by well more than
one percent per year, on average, for
firms with 100 or more employees in
covered industries, indicating that
changes of this magnitude are normal in
these industries and that covered firms
are typically able to withstand such
changes over the course of a year, much
less six months. As discussed below, the
average percentage change due to this
ETS for all covered NAICS is a fraction
of this fluctuation in revenues.
The second screening test that OSHA
traditionally uses to consider whether a
standard is economically feasible for an
affected industry is if the costs of
compliance are less than ten percent of
annual profits (see, e.g., OSHA’s
economic analysis of its Silica standard,
81 FR 16286, 16533 (March 25, 2016);
upheld in N. Am.’s Bldg. Trades Unions
v. OSHA, 878 F.3d 271, 300 (D.C. Cir.
2017)). The ten-percent profit test is also
intended to be at a sufficiently low level
so as to allow OSHA to identify
industries that might require further
examination. Specifically, the profit
screen is primarily used to alert OSHA
to potential impacts on industries where
the price elasticity of demand does not
allow for ready absorption of new costs
in higher prices (e.g., industries with
foreign competition where the American
firms would incur costs that their
foreign competitors would not because
they are not subject to OSHA
requirements). In addition, setting the
threshold for the profit test low permits
OSHA to reasonably conclude that the
rule would be economically feasible for
industries below the threshold. To put
the ten-percent profit threshold test into
perspective, evidence used by OSHA in
its 2016 OSHA silica rule indicates that,
for the combined affected
manufacturing industries in general
industry and maritime from 2000
through 2012, the average year-to-year
fluctuation in profit rates (both up and
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52 Profits are subject to the dynamics of the
overall economy. Many factors, including a national
or global recession, a downturn in a particular
industry, foreign competition, or the increased
competitiveness of producers of close domestic
substitutes are all easily capable of causing a
decline in profit rates in an industry of well in
excess of ten percent in one year or for several years
in succession (See OSHA, March 24, 2016).
53 For information regarding the standards and
practices used by the Census Bureau to ensure the
quality and integrity of its data, see (US Census
Bureau, October 8, 2021a; US Census Bureau,
October 8, 2021b).
54 See IRS, 2013.
55 OSHA also investigated Bizminer and RMA as
potential sources of profit information and
determined that they do not represent adequate and
random samples of the affected industries.
56 There is one code reported per tax entity and
it may not be representative to the six-digit level.
See Corporation Sourcebook on limitations of the
industry classification for details. (IRS, 2013).
down) was 138.5 percent (81 FR
16545).52
When an industry ‘‘passes’’ both the
‘‘cost-to-revenue’’ and ‘‘cost-to-profit’’
screening tests, OSHA is assured that
the costs of compliance with the rule are
economically feasible for that industry.
The vast majority of the industries
covered by the ETS fall into this
category.
A rule is not necessarily economically
infeasible, however, for the industries
that do not pass the initial revenue
screening test (i.e., those for which the
costs of compliance with the rule are
one percent or more of annual
revenues), the initial profit screening
test (i.e, those for which the costs of
compliance are ten percent or more of
annual profits), or both. Instead, OSHA
normally views those industries as
requiring additional examination as to
whether the rule would be economically
feasible (see N. Am.’s Bldg. Trades
Unions v. OSHA, 878 F.3d at 291).
OSHA therefore conducts further
analysis of the industries that ‘‘fail’’ one
or both of the screening tests in order to
evaluate whether the rule would
threaten the existence or competitive
structure of those industries (see United
Steelworkers of Am., AFL–CIO–CLC v.
Marshall, 647 F.2d 1189, 1272 (D.C. Cir.
1980)).
Time Parameters for Analysis
OSHA’s economic analyses almost
always measure the costs of a standard
on an annual basis, conducting the
screening tests by measuring the cost of
the standard against the annual profits
and annual revenues for a given
industry. One year is typically the
minimum period for evaluating the
status of a business; for example, most
business filings for tax or financial
purposes are annual in nature.
Some compliance costs are up-front
costs and others are spread over the
duration of the ETS; regardless, the
costs of the rule overall will not
typically be incurred or absorbed by
businesses all at once. However, OSHA
does not expect that the ETS will
require employers to incur initial capital
costs for equipment to be used over
many years (which would typically be
addressed through installments over a
year or a longer period to leverage loans
or payment options to allow more time
to marshal revenue and minimize
impacts on reserves).
The compliance costs for this ETS are
for a temporary rule for a period of six
months (which, again, is the time period
that OSHA assumes this ETS will last,
solely for economic purposes). While
OSHA believes the most appropriate
screens would be based on annual
profits and revenue, it has followed the
more cautious route of basing the
screens on 6 months of profits and
revenues to avoid any potential
uncertainty about whether the ETS is
economically feasible for the industries
covered by this ETS. Using one year of
revenues and profits as the
denominators in the cost-to-revenue and
cost-to-profit ratios would have resulted
in ratios that are half of the estimated
ratios presented in this analysis. It is
therefore unsurprising that businesses
in some number of NAICs have edged
above the profit-thresholds using a 6
month screen (as will be discussed
later), and OSHA believes that edging
above the screening thresholds is less of
an indicator of economic peril in this
context than in the context of a
permanent rulemaking analysis.
Nevertheless, OSHA has examined each
of the NAICS that did not clear either of
these conservative screening tests and
has concluded that the ETS is
economically feasible for each one.
Data Used for the Screening Tests
The estimated costs of complying
with the ETS, which OSHA relied upon
to examine feasibility is based on the
two tests described above (see OSHA,
October 2021a). The revenue numbers
used to determine cost-to-revenue ratios
were obtained from the 2017 Economic
Census for firms with 100 or more
employees in covered industries. This is
the most current information available
from this source, which OSHA
considers to be the best available source
of revenue data for U.S. businesses.53
OSHA adjusted these figures to 2020
dollars using the Bureau of Economic
Analysis’s GDP deflator, which is
OSHA’s standard source for inflation
and deflation analysis.
The profit screening test for feasibility
(i.e., the cost-to-profit ratio) was
calculated as ETS costs divided by
profits. Profits were calculated as profit
rates multiplied by revenues. The
before-tax profit rates that OSHA used
were estimated using corporate balance
sheet data from the Internal Revenue
Service (IRS), 2013 Corporation Source
Book (IRS, 2013). The IRS discontinued
the publication of these data after 2013,
and therefore the most current years
available are 2000–2013.54 The most
recent version of the Source Book
represents the best available evidence
for these data on profit rates.55
For each of the years 2000 through
2013, OSHA calculated profit rates by
dividing the ‘‘net income’’ from all firms
(both profitable and unprofitable) by
total receipts from all firms (both
profitable and unprofitable) for each
NAICS.56 OSHA then averaged these
rates across the 14-year (2000 through
2013) period. Since some data provided
by the IRS were not available at
disaggregated levels for all industries
and profit rates, data at more highly
aggregated levels were used for some
industries; that is, where data were not
available for each six-digit NAICS code,
data for the corresponding four- or five-
digit NAICS codes were used. Data were
used for all firms in the NAICS (as
opposed to just firms with 100 or more
employees) since data disaggregated by
employment size-class were not
available. Profit rates are expressed as a
percentage (see OSHA, October 2021a).
Profits themselves were used to
calculate the cost-to-profit estimates for
all firms contained in a particular
NAICS code (see OSHA, October 2021a).
OSHA has estimated costs over a 6-
month timeframe for this ETS. As
discussed above, OSHA has therefore
used six months of revenue to conduct
the cost-to-revenue tests and six months
of profit to conduct the cost-to-profit
tests.
General Use of Revenues and Profits To
Measure Economic Feasibility
As with other OSHA rulemaking
efforts, the agency relies on the two
screening tests (costs less than one
percent of revenue and costs less than
ten percent of profit) as an initial
indicator of economic feasibility. OSHA
has generally found that the cost-to-
revenue test is a more reliable indicator
of feasibility simply because the
revenue data are more accurate than the
profit data. There are several reasons for
this.
First, OSHA has been using corporate
balance sheet data from the IRS as the
best available evidence for estimating
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57 OSHA funded and accepted a final report by
Contractor Henry Beale (Beale Report, 2003) that
reviewed alternative financial data sources and
concluded that the IRS data were the best. Since
then OSHA has been relying on IRS data to provide
the financial data to support its rulemaking
analyses. See, for example, Occupational Safety and
Health Administration (OSHA) (2016), Final
Economic and Regulatory Flexibility Analysis for
OSHA’s Rule on Occupational Exposure to
Respirable Crystalline Silica, Chapter VI, pp. VI–2
to VI–3, Docket No. OSHA–2010–0034–4247
(OSHA, March 24, 2016), which includes a more
recent review of data sources for corporate financial
profit data and further support for OSHA’s choice
of IRS data.
58 In fact, all other Department of Labor agencies
rely solely on revenues to assess economic impacts,
such as Regulatory Flexibility Act certifications, in
their rulemakings (see, e.g., Employment and
Training Administration, Final Rule on
Strengthening Wage Protections for the Temporary
and Permanent Employment of Certain Aliens in
the United States, https://www.govinfo.gov/content/
pkg/FR-2021-01-14/pdf/2021-00218.pdf; Wage and
Hour Division, Tip Regulations Under the Fair
Labor Standards Act (FLSA), https://
www.govinfo.gov/content/pkg/FR-2020-12-30/pdf/
2020-28555.pdf).
59 While fixed cost can be more limiting in terms
of options for businesses, most of the costs of this
rule are not fixed. Instead, most of the compliance
costs vary with the level of output or employment
at a facility.
corporate profits for years.57
Nevertheless, because firms typically
have an incentive to minimize their tax
burden, it is reasonable to expect that
some of the reported accounting data
may have been strategically adjusted to
reduce reported profits and their
associated tax implications. Business
profits are much more likely to reflect
such strategic accounting than business
revenues; accordingly, revenues are a
more accurate measure than profits for
evaluating economic feasibility for a
multitude of reasons.58
Second, because OSHA is using data
from both profitable and unprofitable
firms, the average profit rate for a small
number of industries is negative (as
described above, using 14 years of data
that predate the pandemic). This result
could have occurred because of the way
profits are calculated, which
unnaturally skews average profit rates
downward by including firms that have
large losses (negative profits) or
subnormal profits and have already
closed or are in the process of closing,
irrespective of any action by OSHA. The
negative rates could also be the result of
macroeconomic fluctuations during the
14-year period used to determine the
average, a period in which some of these
industries may have experienced
unusually adverse financial impacts
(see, e.g., the explanation in Chapter VI,
pp. VI–20 of the Final Economic and
Regulatory Flexibility Analysis for
OSHA’s Rule on Occupational Exposure
to Respirable Crystalline Silica, Docket
No. OSHA–2010–0034–4247, which
notes the skew from negative impacts
during recession years (OSHA, March
24, 2016)). Or they could result from
tax-related incentives, as previously
noted.
Whatever the reason, the cost-to-profit
calculations for NAICS with negative
profit rates fail to provide reliable
information about the long-term
profitability of these industries,
independent of the ETS. Companies and
industries that consistently lose money
do not typically stay in business, and
would almost certainly not still be in
business in 2021 if that loss continued
at the same level for each of the 8 years
since the profit data was published in
2012. Revenue streams are a more
dependable measure for those firms
because those streams tend to be more
stable and more indicative of the actual
capabilities of sustainable firms than
reported negative profit margins. As a
result, for the purposes of this analysis,
OSHA has relied more heavily on its
cost-to-revenue estimates, in lieu of
cost-to-profit estimates, as the more
reliable indicator for economic
feasibility for the industries with
negative profit rates.
Third, and similarly, profit rates that
are only slightly positive (i.e., less than
one percent) are inconclusive and not
useful for the purpose of OSHA’s cost-
to-profit test. In economics terms, profit
entails a reasonable rate of return on
investment, and long-term profits of less
than one percent a year are not generally
reasonable for firms that expect to
remain in business. Thus data showing
industry-wide profits in this range do
not measure the true ability of
companies to pay for the ETS costs. As
previously stated, revenue streams tend
to be more stable and more indicative of
the actual capabilities of sustainable
firms. Therefore, where possible, OSHA
prefers to rely on the cost-to-revenue
test to evaluate economic feasibility for
industries that have a less than one
percent profit rate.
The qualification, and by far the most
important reason for the general
primacy of revenues versus profits as
the appropriate metric for determining
economic feasibility, for most OSHA
rules, is that the regulated firms are able
to pass on the costs of the rule in the
form of higher prices. When they
cannot, the profit test functions
primarily as a screen for a limited
purpose: Alerting OSHA to potential
impacts where unregulated competitors
can prevent firms from passing costs
along to customers.
To understand this point, some
economic background is needed. The
price elasticity of demand refers to the
relationship between the price charged
for a product or service and the quantity
demanded for that product or service:
The more elastic the relationship, the
larger the decrease in the quantity
demanded for a product when the price
goes up. When demand is elastic,
establishments have less ability to pass
compliance costs on to customers in the
form of a price increase and must absorb
such costs in the form of reduced
profits. In contrast, when demand is
relatively inelastic, the quantity
demanded for the product or service
will be less affected by a change in
price. In such cases, establishments can
recover most of the variable costs of
compliance (i.e., costs that are highly
correlated with the amount of output)
by raising the prices they charge; under
this scenario, if costs are variable rather
than fixed, business activity and profit
rates are largely unchanged for small
changes in costs. Ultimately, where
demand is relatively inelastic, any
impacts are primarily borne by those
customers who purchase the relevant
product or service for a slightly higher
price. Most of the costs of this ETS are
variable costs because they depend
primarily on the level of production or
the number of employees at an
establishment. For example, under the
ETS, a firm with 500 employees must
determine and record the vaccination
status of 500 employees, while a firm
with 250 employees need determine and
record the vaccination status of only 250
employees.59
In general, ‘‘[w]hen an industry is
subjected to a higher cost, it does not
simply swallow it; it raises its price and
reduces its output, and in this way
shifts a part of the cost to its consumers
and a part to its suppliers’’ (Am. Dental
Ass’n v. Sec’y of Labor, 984 F.2d 823,
829 (7th Cir. 1993)). A reduction in
output could happen in a variety of
ways: Individual establishments could
reduce their levels of service (e.g., retail
firms) or production (e.g.,
manufacturing), both of which could
take the form of a reduction of worker
hours; some marginal establishments
could close; or, in the case of an
industry with high turnover of
establishments, new entry could be
delayed until demand equals supply. In
many cases, a decrease in overall output
for an industry will be a combination of
all three kinds of reductions. The
primary means of achieving the
reduction in output most likely depends
on the rate of turnover in the industry
and on the form that the costs of the
regulation take. Further, the temporary
nature of the ETS and its associated
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60 This cost advantage may be exaggerated or non-
existent in many cases (see the discussion directly
below in the text in Caveat 2).
61 Several occupational groups less able to avoid
exposure to SARS–CoV–2 infection exhibited
significantly higher rates of absenteeism in March–
April 2020 compared to earlier periods
(Groenewold et al., July 10, 2020).
62 For a discussion of turnover (i.e. whether the
ETS could affect the likelihood that an employee
will remain with an employer, either because the
imposition of a vaccine requirement will lead some
employees to leave and find employment at an
establishment not subject to the ETS, or,
alternatively, to stay due to a preference for
enhanced COVID–19 safety procedures), please see
the cost section (Section III.d.) of this economic
analysis.
63 By OSHA’s calculation, 524 out of the 546 six-
digit NAICS covered by the ETS.
costs suggests that firms may have more
flexibility to respond than when facing
a permanent increase in costs. For
example, firms may be able to
temporarily increase prices or
temporarily defer planned capital
expenditures or other maintenance to
cover compliance costs.
There are two situations typically
mentioned when an industry subject to
regulatory costs might be unable to pass
those costs on: (1) Foreign competition
not subject to the regulation, or (2)
domestic competitors in other
industries, not subject to the regulation,
that produce goods or services that are
close substitutes. Otherwise, when all
affected domestic industries are covered
by a rule and foreign businesses must
also comply with the rule or are unable
to compete effectively, the ability of a
competing industry to offer a substitute
product or service at a lower price is
greatly diminished.
There is a third situation that is
relevant to this ETS—when only some
firms in a domestic industry (in this
case, only employers with 100 or more
employees) are subject to the ETS and
its regulatory costs. In principle,
competition from smaller employers in
a NAICS could prevent the larger
employers from passing on their costs in
the form of higher prices and instead
require them to absorb the costs in the
form of lost profits. There are, however,
several important caveats:
1. As a practical matter, it is
implausible to expect that covered
employers (with 100 or more
employees) would feel constrained by
smaller competitors in their industry so
as not to pass on costs for a rule lasting
6 months that imposes costs equal to
0.02 percent of revenues, on average
across all NAICS, over that time period
(see OSHA, October 2021a). This time
period would likely be too short for
small firms to expand to take business
away from the larger firms or for new
firms to form to take advantage of such
minor and transitory business
opportunities. Furthermore, smaller
firms (particularly very small firms—
those with fewer than 20 employees)
typically can’t compete on price with
large firms that have cost advantages
due to various economies of scale; as a
result, smaller firms often serve a
specialized niche market rather than
compete directly with larger firms. To
the extent that this ETS creates new
business opportunities for these smaller
uncovered firms, they would also be
covered by the ETS as soon as they
reached 100 employees.60
2. An important factor to consider in
calculating the costs and impacts and
economic feasibility of this ETS is the
unquantified and unmonetized cost
savings and other positive economic
impacts accruing to employers that
comply with the ETS. These include
reduced absenteeism due to COVID–19
illnesses 61 and quarantine.62 Other
positive economic impacts that
compliant employers would enjoy from
a safer business environment are
increased retail trade from customers
that feel less at risk and better relations
with suppliers and other business
partners. These all would contribute to
improved business and increased
profits.
3. The existence of these cost savings
and other positive economic impacts
accruing to employers that comply with
the ETS suggests that the actual net
costs of the ETS will be much lower
than the costs reported in the
supporting economic analysis for this
ETS used to estimate cost impacts and
demonstrate economic feasibility. In
fact, for some share of covered
employers, the net costs of the ETS may
well be negative. Indeed, this is being
confirmed by revealed preference in the
market. Elsewhere in the economic
analysis for this ETS (Cost Analysis
section 4.2), OSHA has provided
evidence to support its estimate that 25
percent of covered employers already
voluntarily require that their employees
be vaccinated and a much larger
percentage are considering a vaccine
mandate. This strongly supports the
conclusion that these businesses agree
that doing so will ultimately save costs.
b. Economic Feasibility Analysis and
Determination
This section summarizes OSHA’s
feasibility findings for industries
covered by the ETS. As stated
previously, the agency uses two
screening tests (costs less than one
percent of revenue and costs less than
ten percent of profit) as an initial
indicator of economic feasibility. In this
section, OSHA discusses the industries
that fall above the threshold level for
either screening test.
The overall effect of compliance with
the general section of the ETS on
covered industries is very small (see
OSHA, October 2021a). The vast
majority of the covered NAICS have
very low cost-to-revenue and cost-to-
profit ratios, with the overall averages
being 0.02 percent of revenues and 0.49
percent of profits. To put this into
perspective, if the average firm decided
to raise prices to cover the costs of the
ETS, the price of a $100 product or
service, for example, would have to be
increased by 2 cents (during the six-
month period).
Based on the information presented
here, the costs of the ETS are below both
the threshold revenue test (1 percent of
revenues) and the threshold profit test
(10 percent of profits) for the vast
majority of NAICS industries.63 This
indicates that the average firm in these
industries will be able either to raise
prices to cover ETS costs or to absorb
the costs of the ETS out of available
profits. In either case, OSHA concludes
that the ETS is economically feasible for
all of these industries.
Critically, there are no industries
covered by the general section of the
ETS that are above OSHA’s cost-to-
revenue threshold level of one percent
and most are a small fraction of this
level. Because OSHA is using data from
both profitable and unprofitable firms,
the average profit rate for a small
number of industries is negative. There
are 14 NAICS with negative cost-to-
profit ratios, resulting from negative
average profit rates. These industries
with negative profit rates are domestic
service industries that are not subject to
international competition.
There are eight six-digit NAICS
industries, covering all establishments
in those industries covered by the
general section of the ETS, with cost-to-
profit ratios above 10 percent:
1. NAICS 221118—Other Electric
Power Generation, 23.97 percent;
2. NAICS 488119—Other Airport
Operations, 18.41 percent;
3. NAICS 488410—Motor Vehicle
Towing, 15.75 percent;
4. NAICS 488490—Other Support
Activities for Road Transportation,
14.32 percent;
5. NAICS 713920—Skiing Facilities,
13.16 percent; and
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64 If not underpriced by smaller firms, covered
firms in the 8 NAICS industries reporting ETS costs
above 10 percent of profits could cover these costs
by raising prices an average of 0.08 percent (highest,
0.11 percent); covered firms in the 14 NAICS
industries reporting negative profits could cover
ETS costs with a price increase of 0.01 percent
(highest, 0.02 percent).
6. NAICS 713940—Fitness and
Recreational Sports Centers, 12.33
percent;
7. NAICS 713120—Amusement
Arcades, 11.18 percent; and
8. NAICS 488320—Marine Cargo
Handling, 10.03 percent.
The average profit rate reported over
the 14 years for which OSHA has profit
data for all the NAICS affected by the
ETS is 4.2 percent. All of the eight
NAICS industries with a cost-to-profit
ratio above the 10 percent threshold
report an annual profit rate below one
percent—75 percent or more below the
overall average for all NAICS covered by
the ETS. These eight industries all
provide domestic services and are not
subject to international competition.
The fact that the covered firms in
these 22 NAICS industries (the 14 with
negative cost-to-profit ratios and the 8
with more sustainable cost-to-profit
ratios) exceeded the profit screen
suggests that they might in theory have
difficulty paying for the costs of the ETS
out of profits gained over the six-month
duration of the ETS if they had no
savings or access to capital, but even if
that were true it would be highly
unlikely to place the firms in financial
jeopardy. OSHA examines these
industries more closely below, but
before even considering the reasons in
NAICs-specific analysis it is important
to consider the larger context. For the
ETS to threaten the economic solvency
of these firms, the following 3
conditions must apply:
1. These firms must not enjoy certain
cost savings and positive economic
impacts from the ETS that would
partially or totally offset their costs.
This condition is questionable because
of the estimated 25 percent of employers
sampled that reported voluntarily
imposing a vaccine mandate and the
substantial number more contemplating
the voluntary adoption of such a
mandate. They can be expected to base
their decisions, partly or entirely, on
anticipated cost savings or positive
economic impacts (which would reduce
or eliminate their risk of insolvency due
to the ETS).
2. These firms (all with 100 or more
employees) must not be able to raise
prices to cover ETS costs because of the
threat that smaller firms in their NAICS
industry, not covered by the ETS, could
underprice them and take away their
business. This condition is unlikely or
limited because of the economies of
scale the larger firms enjoy and the fact
that the smaller firms out of necessity
tend to serve a market niche not in
direct competition with the larger firms.
Also, there is a severe limit to the extent
that firms with fewer than 100
employees can take away significant
portions of business from the larger
firms without becoming subject to the
requirements of the rule themselves. If
the larger firms do not feel threatened
by being underpriced by smaller firms
in these NAICS industries, then they
could raise prices an average of less
than 0.05 percent 64 to cover the cost of
the ETS—a small fraction of the 1.0
percent of revenues threshold (beneath
which OSHA has determined that
economic feasibility is not a concern).
3. These firms must not generate
sufficient profits or have adequate
borrowing capacity during the six
months the ETS is in force to cover the
costs of the ETS. There are several
reasons to doubt that this condition
broadly applies. First, the estimates of
business profits come from corporate
balance sheet data that firms report to
the IRS. But, as previously noted, it is
generally the case that firms have an
incentive to minimize their tax burden,
and it is reasonable to expect that some
of the reported accounting data may
have been strategically adjusted to
reduce reported profits and their
associated tax implications. Another
point concerning the IRS data is that
they include the negative profits of
firms that are going out of business or
have since gone out of business. To the
extent that these points are true, many
or most of the covered firms in these
NAICS industries (still in business)
actually would generate sufficient profit
to cover the cost of the ETS. A related
point is that for this condition to apply,
the firms must not be able to borrow the
money to pay for the costs of the ETS.
Recall, however, that these are all large
firms with 100+ employees. It is
reasonable to expect that many or most
firms of this size in the 22 NAICS
industries at issue either have available
funds or could obtain a short-term loan
to cover costs equal to the 0.01 to 0.11
percent of revenues that these firms
would incur over the six-month period
that OSHA assumes the ETS will remain
in effect. Firms of this size normally
have banking relationships and some
unencumbered assets. They also have
access to national and international
capital markets. If these firms can
borrow funds to pay for the ETS, then
the profit restriction doesn’t matter.
Finally, OSHA anticipates concern
that limiting the scope of the ETS to
employers with 100 or more employees
will somehow put these larger firms in
economic jeopardy from the smaller
firms to which the ETS does not
currently apply. This is highly
improbable for several reasons
discussed earlier, including the fact that
these are large employers with
advantages of economies of scale and
access to capital and the fact that this is
a temporary standard that would result,
at most, in marginal impacts over 6
months (on average, equal to costs of
0.02 percent of revenues, which, again,
translates to a cost increase of a penny
on a fifty dollar item).
But even that misses the main point:
Economic feasibility refers to the
industry, not to the firm. OSHA must
construct a reasonable estimate of
compliance costs and demonstrate a
reasonable likelihood that these costs
will not threaten the existence or
competitive structure of an industry,
even if it does portend disaster for some
marginal firms (Lead I, 647 F.2d at
1272). In the (again) highly unlikely
event that individual firms exit an
industry and are replaced by other firms
in the industry, then the ETS would
preserve the economic feasibility of the
covered industries. If an employer
covered by this standard actually had to
increase its prices slightly to account for
the cost of this standard, there are two
potential groups of smaller businesses
that could seek to supplant the covered
firms. The first group of businesses are
much smaller than the covered firms.
Those businesses, however, will
typically have higher costs and prices to
begin with due to their scale
disadvantages to the larger firms. The
larger firm’s small price increases
attributable to this ETS would not be
likely to create an actionable
competitive advantage for this group of
smaller businesses. The second group of
businesses are those closer in size to the
100-employee cutoff. If the marginal
price increases did actually cause some
of the larger firms to fail and the slightly
smaller firms to take their place, the
industry itself would not suffer a
massive dislocation or be imperiled.
And, of course, if all of the firms in an
industry are large employers with 100 or
more employees, no competitive
disadvantage from within the industry
would exist (even hypothetically), and
there would be no question that they
could cover the cost of ETS by raising
prices to customers accordingly.
Although the preceding discussion
demonstrates that the ETS is
economically feasible, OSHA has
provided an additional examination of
each of the NAICS that have crossed the
profit screen (again noting that none of
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65 See Walker, January 22, 2013.
66 This U.S. industry comprises establishments
primarily engaged in (1) operating international,
national, or regional airports, or public flying fields
or (2) supporting airport operations, such as rental
of hangar space, and providing baggage handling
and/or cargo handling services.
67 This industry comprises establishments
primarily engaged in towing light or heavy motor
vehicles, both local and long-distance. These
establishments may provide incidental services,
such as storage and emergency road repair services.
68 This industry comprises establishments
primarily engaged in providing services (except
motor vehicle towing) to road network users.
69 This industry comprises establishments
engaged in (1) operating downhill, cross country, or
related skiing areas and/or (2) operating equipment,
such as ski lifts and tows. These establishments
often provide food and beverage services,
equipment rental services, and ski instruction
services. Four season resorts without
accommodations are included in this industry.
70 See Brown, January 19, 2017, ‘‘[o]f the 9.4
million skiers in the U.S., more than half earn a
salary higher than $100,000. For some context, only
20 percent of American households have a
combined income of $100K. . . .’’)
71 This industry comprises establishments
primarily engaged in operating fitness and
recreational sports facilities featuring exercise and
other active physical fitness conditioning or
recreational sports activities, such as swimming,
skating, or racquet sports.
these failed the revenue screen): The
eight NAICS industries with positive
profit ratios but profit rates below 1
percent.
1. NAICS 221118—Other Electric Power
Generation, 23.97 Percent
This U.S. industry comprises
establishments primarily engaged in
operating electric power generation
facilities (except hydroelectric, fossil
fuel, nuclear, solar, wind, geothermal,
biomass). These facilities convert other
forms of energy, such as tidal power,
into electric energy. The electric energy
produced in these establishments is
provided to electric power transmission
systems or to electric power distribution
systems.
Using tides to generate power is not
yet economically viable, according to
one source, because ‘‘[t]otal availability
of tidal power is restricted by its
relatively high cost and limited number
of sites having high flow velocities and
tidal ranges,’’ although ‘‘with [ ] recent
advancements in tidal technologies, the
total availability of tidal power in terms
of turbine technology as well as design
may be higher than before, and the
economic costs may be reduced
significantly to competitive levels.’’ In
support, in the same article, ‘‘recent
reports state that the UK, which has the
largest tidal and wave resource in
Europe, is capable of harnessing up to
153GW of tidal power capacity with the
help of three types of technologies and
thus meeting 20% of current UK
electricity demand and reducing carbon
emissions. Hence it is evident that wave
and tidal energy could contribute more
to the increasing electricity demands
across the globe.’’ 65
At the time OSHA obtained the most
recent NAICS data, there were 7 affected
entities in this NAICS industry. The
entities in this NAICS industry include
firms like Berkshire Hathaway Energy
Company, (with annual sales of $19.8
billion, whose ‘‘portfolio consists of
locally managed business that share a
vision for a secure and sustainable
energy future’’); Dominion Energy (with
annual sales of $13.4 billion); and other
leading firms in this industry including
some of the largest power generation
companies in the US (See NAICS
Association, 2018a; NAICS Association
2018d; and NAICS Association 2018e).
As this NAICS industry is not yet
viable, (in the United States, at least), it
is to be expected that revenues and
profits would be low. In fact, OSHA
believes the best way to view this
industry is as a series of incredibly well-
funded start-up companies during the
investment phase of the business, where
short-term losses are expected and offset
with the anticipation of enormous
revenue growth potential (in an
acknowledged very limited energy
market.) Given these factors, OSHA’s
typical revenue and profit screen are a
poor predictor of future viability with
respect to this NAICS industry
(although, as pointed out, this NAICS
industry, like all other NAICS
industries, falls well below the revenue
screen threshold). The estimated cost of
this ETS per firm is $866 in this NAICS
industry, which equals about 11 cents
per hundred dollars of revenue over a
limited six-month duration. OSHA
concludes that this industry will be able
to withstand this small cost in order to
keep its workers protected during the
pandemic.
2. NAICS 488119—Other Airport
Operations, 18.41 Percent 66
The services this industry offers are
integrated into a particular geographic
location and entail specific tasks, such
as parking and baggage handling
services, that must be done to ensure the
proper functioning of airports, thus
negating the potential for substitution
during the 6 month period that OSHA
is assuming the ETS will be in effect for
economic purposes. In addition,
because these are services that need to
be done in particular domestic locations
(i.e., airports), there is no risk of
international competition.
3. NAICS 488410—Motor Vehicle
Towing, 15.75 Percent 67
The actual cost impacts on this
industry are likely significantly
overstated to the extent that most
employees performing towing services
ride alone in their trucks and their
services do not typically require
exposure to others. In the event that
individual large towing firms are
concerned about economic impacts, it
would not be difficult to structure their
employee interactions with the
company and customers to take
advantage of the scope restrictions.
Moreover, the primary services this
industry offers involve the use of
specialized vehicles designed uniquely
for towing, thus lowering the risk of
substitution. In addition, because these
services are geographically based, there
is no risk of international competition.
4. NAICS 488490—Other Support
Activities for Road Transportation,
14.32 Percent 68
This industry offers services that must
be done to ensure proper operation of
roadways (for example, bridge, tunnel,
and highway operations, pilot car
services (i.e., wide load warning
services), driving services (e.g.,
automobile, truck delivery), and truck or
weighing station operations), thus
negating the potential for substitution.
In addition, because these services need
to be done in particular domestic
locations (i.e., roadways), there is no
risk of international competition.
5. NAICS 713920—Skiing Facilities,
13.16 Percent 69
This industry caters to a wealthy
clientele who ensure an inelastic
demand easily capable of absorbing any
fractional increases attributable to this
ETS.70 In addition, skiing is done
outdoors, which will incentivize
clientele to continue engaging in this
particular activity in lieu of indoor
substitutions, during the pandemic.
Finally, there is little to no risk of
international competition from foreign
ski resorts because the added and
substantial costs of international travel
outweigh the costs associated with
marginally higher prices resulting from
the ETS.
6. NAICS 713940—Fitness and
Recreational Sports Centers, 12.33
Percent 71
As these settings are generally located
close to where clients live or work, there
is no risk of international competition.
Some of the largest employers in this
industry have already responded to
customer feedback by not only requiring
employees to be vaccinated, but also
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72 See Jackson, August 2, 2021 ‘‘Equinox also
noted in the press release that ‘an overwhelming
majority of members’ have expressed support for a
vaccination requirement for entry to Equinox
clubs.’’
73 This industry comprises establishments
primarily engaged in operating amusement (except
gambling, billiard, or pool) arcades and parlors.
74 This industry comprises establishments
primarily engaged in providing stevedoring and
other marine cargo handling services (except
warehousing).
75 NAICS 481111 (Scheduled Passenger Air
Transportation) provides air transportation of
passengers or passengers and freight over regular
routes and on regular schedules, including
commuter and helicopter carriers (except scenic
and sightseeing). NAICS 481112 (Scheduled Freight
Air Transportation) provides air transportation of
cargo without transporting passengers over regular
routes and on regular schedules, including
scheduled air transportation of mail on a contract
basis. NAICS 481211 (Nonscheduled Chartered
Passenger Air Transportation) provides air
transportation of passengers or passengers and
cargo with no regular routes and regular schedules.
NAICS 481212 (Nonscheduled Chartered Freight
Air Transportation) provides air transportation of
cargo without transporting passengers with no
regular routes and regular schedules. NAICS 481219
(Other Nonscheduled Air Transportation) provides
air transportation with no regular routes and regular
schedules (except nonscheduled chartered
passenger and/or cargo air transportation). These
establishments provide a variety of specialty air
transportation or flying services based on
individual customer needs using general purpose
aircraft.
76 NAICS 517311 (Wired Telecommunications
Carriers) comprises establishments primarily
engaged in operating and/or providing access to
transmission facilities and infrastructure that they
own and/or lease for the transmission of voice, data,
text, sound, and video using wired
telecommunications networks. Establishments in
this industry use the wired telecommunications
network facilities that they operate to provide a
variety of services, such as wired telephony
services, including VoIP services; wired (cable)
audio and video programming distribution; wired
broadband internet services; and, by exception,
establishments providing satellite television
distribution services using facilities and
infrastructure that they operate are included in this
industry. NAICS 517312 (Wireless
Telecommunications Carriers (except Satellite))
comprises establishments primarily engaged in
operating and maintaining switching and
transmission facilities to provide communications
via the airwaves. Establishments in this industry
have spectrum licenses and provide services using
that spectrum, such as cellular phone services,
paging services, wireless internet access, and
wireless video services. NAICS 517410 (Satellite
Telecommunications) comprises establishments
primarily engaged in providing telecommunications
services to other establishments in the
telecommunications and broadcasting industries by
forwarding and receiving communications signals
via a system of satellites or reselling satellite
telecommunications. NAICS 517911
(Telecommunications Resellers) comprises
establishments engaged in purchasing access and
network capacity from owners and operators of
telecommunications networks and reselling wired
and wireless telecommunications services (except
satellite) to businesses and households.
Establishments in this industry resell
telecommunications; they do not operate
transmission facilities and infrastructure. NAICS
517919 (All Other Telecommunications) comprises
establishments primarily engaged in providing
specialized telecommunications services, such as
satellite tracking, communications telemetry, and
radar station operation, and also includes
establishments primarily engaged in providing
satellite terminal stations and associated facilities
connected with one or more terrestrial systems and
capable of transmitting telecommunications to, and
receiving telecommunications from, satellite
systems, as well as establishments providing
internet services or Voice over internet protocol
(VoIP) services via client-supplied
telecommunications connections.
members.72 This suggests both that the
costs estimates attributed to the ETS are
overstated for these employers because
higher levels of compliance may have
already occurred than projected in
OSHA’s analysis, and that the ETS
requirements reflect more of an industry
trend than a threat to the existence of
the industry.
7. NAICS 713120—Amusement
Arcades, 11.18 Percent 73
This industry caters to a select
clientele who have chosen to engage in
leisure activities in the unique settings
offered by the industry, thus negating
the likelihood for substitution. In
addition, because these settings are
localized, there is no risk of
international competition.
8. NAICS 488320—Marine Cargo
Handling, 10.03 Percent 74
The services this industry offers are
integrated into a particular location and
entail specific tasks, such as loading and
unloading services at ports and harbors,
longshoremen services, marine cargo
handling services, ship hold cleaning
services, and stevedoring services, that
must be done to ensure the proper
movement of cargo off of and onto
ships, thus negating the potential for
substitution. In addition, because these
are services that need to be done in
particular domestic locations (e.g.,
docks), there is no risk of international
competition.
As with towing, the actual cost
impacts on this industry are likely
significantly overstated to the extent
that some of the employees may be able
to perform their work exclusively
outdoors.
The Fourteen NAICS Industries With
Negative Profit Ratios
1. Air Transportation 75
NAICS 481111 (Scheduled Passenger
Air Transportation), NAICS 481112
(Scheduled Freight Air Transportation),
NAICS 481211 (Nonscheduled
Chartered Passenger Air
Transportation), NAICS 481212
(Nonscheduled Chartered Freight Air
Transportation), NAICS 481219 (Other
Nonscheduled Air Transportation).
This group of NAICS industries is
comprised of U.S. industries that
primarily engage in providing air
transportation. There is little to no risk
of substitution for this group of NAICS
industries. Air transportation provides
unique and important benefits that
cannot be substituted via other forms of
transportation (e.g., rail, freight, bus).
(See ATAG, September 2005). To this
end, air transportation is often the
speediest means of transporting
passengers and cargo, giving it a unique
purpose that cannot be met by other
forms of transport. It should be noted
that the five NAICS in this group of
industries are the only NAICS in NAICS
4811 (Scheduled Air Transportation)
and 4812 (Nonscheduled Air
Transportation). The other industries in
NAICS 48 (Transportation) do not
provide air transportation (See NAICS
Association, 2018b). This further
reduces the risk of substitution, as all
five NAICS at issue have a negative
profit ratio and therefore face similar
challenges that appear to be endemic to
air transportation. Firms in this industry
that have been able to weather the
pandemic this long are typically highly
capitalized or have access to loans, so it
is highly likely that they could also
weather the temporary marginal costs of
OSHA’s ETS.
There is also no risk of international
competition with respect to this group
of NAICS industries because any
workers, whether they work for an
international company or not, who are
in the US, are subject to US laws,
including the ETS, and foreign air
carriers will need to follow the ETS for
those workers. In addition, OSHA
suspects that any smaller foreign air
carriers will not have an incentive to
expand their routes significantly or
change their routes to domestic US
routes to take advantage of the 100-
employee cutoff in the ETS in the 6-
months the ETS is assumed to be in
effect.
2. Telecommunications 76
NAICS 517311 (Wired
Telecommunications Carriers), NAICS
517312 (Wireless Telecommunications
Carriers (except Satellite), NAICS
517410 (Satellite Telecommunications),
NAICS 517911 (Telecommunications
Resellers), NAICS 517919 (All Other
Telecommunications).
This group of NAICS industries is
entirely comprised of U.S. industries,
except for NAICS 517410 (Satellite
Telecommunications). All of these
industries provide specialized unique
services in the telecommunications
industry that require specialized unique
knowledge and are thus resistant to
substitution. While it is perhaps
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77 NAICS 532111 (Passenger Car Rental)
comprises establishments primarily engaged in
renting passenger cars without drivers, generally for
short periods of time. NAICS 532112 (Passenger Car
Leasing) comprises establishments primarily
engaged in leasing passenger cars without drivers,
generally for long periods of time. NAICS 532120
(Truck, Utility Trailer, and RV (Recreational
Vehicle) Rental and Leasing comprises
establishments primarily engaged in renting or
leasing, without drivers, one or more of the
following: Trucks, truck tractors, buses, semi-
trailers, utility trailers, or RVs (recreational
vehicles). NAICS 532310 (General Rental Centers)
comprises establishments primarily engaged in
renting a range of consumer, commercial, and
industrial equipment. Establishments in this
industry typically operate from conveniently
located facilities where they maintain inventories of
goods and equipment that they rent for short
periods of time. The type of equipment that
establishments in this industry provide often
includes, but is not limited to: Audio visual
equipment, contractors’ and builders’ tools and
equipment, home repair tools, lawn and garden
equipment, moving equipment and supplies, and
party and banquet equipment and supplies.
78 See Park, January 23, 2021.
possible that different forms of
telecommunications might be
substituted for one another (e.g., the
substitution of wired
telecommunications carriers for wireless
telecommunications carriers), the reality
is that these different forms exist
separately and feed different markets
and customer needs that are
independent of the ETS. Moreover, the
five NAICS in this group of industries
are the only NAICS in NAICS 5173
(Wired and Wireless
Telecommunications Carriers), NAICS
5174 (Satellite Telecommunications),
and NAICS 5179 (Other
Telecommunications). The other
industries in NAICS 51 (Information)
are not engaged in telecommunications
(NAICS Association, 2018c). This
further reduces the risk of one industry
substituting for the others, as all five
NAICS at issue have a negative profit
ratio and therefore face similar
challenges that appear to be endemic to
telecommunications.
Moreover, three of the five NAICS
industries in this group (NAICS 517311,
517312, 517410) operate or control the
infrastructure needed for engaging in
the particular type of
telecommunications in which those
industries engage. This not only fully
negates the risk of substitution, but also
negates the risk of international
competition for these industries.
The other two industries in the group
apparently do not operate or control the
infrastructure needed for
telecommunications. However, the
telecommunications industry faces strict
state and federal licensing requirements,
which severely limit the risk of
competition both internationally and
from smaller firms seeking to take
advantage of the ETS’s 100-employee
cutoff. (See FCC, 2014; FCC, October 12,
2021a; FCC, October 12, 2021b;
Caltrans, October 12, 2021; and UTC,
October 12, 2021).
3. Car and Equipment Rental 77
NAICS 532111 (Passenger Car Rental),
NAICS 532112 (Passenger Car Leasing),
NAICS 532120 (Truck, Utility Trailer),
and RV (Recreational Vehicle) Rental
and Leasing) NAICS 532310 (General
Rental Centers).
This group of industries rent motor
vehicles (NAICS 532111, 532112,
532120) or equipment (NAICS 532310),
for example, audio visual equipment,
contractors’ and builders’ tools and
equipment, home repair tools, lawn and
garden equipment, moving equipment
and supplies, and party and banquet
equipment and supplies, to individuals
and businesses, for personal and
professional use. There is no risk of
substitution with respect to these
industries, as these industries rent
specific items to those who want to use
them. There is also no risk of foreign
competition with respect to these
industries, as consumers and businesses
rent and pick up vehicles, as well as the
type of equipment offered for rent by
NAICS 532310, from specific locations,
including car rental and other rental
centers.
These industries have not been hard
hit by the pandemic, as many
consumers have turned from group
travel to individual transportation. For
example, RV rentals and leasing has
soared during the pandemic, which is
not reflected in the pre-pandemic profit
and revenue data available for this
analysis.78
References
Air Transport Action Group (ATAG). (2005,
September). The economic & social
benefits of air transport. https://
www.icao.int/meetings/wrdss2011/
documents/jointworkshop2005/atag_
socialbenefitsairtransport.pdf. (ATAG,
September 2005)
Beale HBR. (2003). Financial Data Sources.
Microeconomic Applications Inc. (Beale
Report, 2003)
Brown J. (2017, January 19). Bring More
Diversity to Skiing. https://
www.powder.com/stories/opinion/
extend-the-family/. (Brown, January 19,
2017)
Caltrans. (2021, October 12). Wireless
Licensing Program, California
Department of Transportation. https://
dot.ca.gov/programs/right-of-way/
wireless-licensing-program. (Caltrans,
October 12, 2021)
Federal Communications Commission (FCC).
(2021, October 12a) Licensing. https://
www.fcc.gov/licensing-databases/
licensing. (FCC, October 12, 2021a)
Federal Communications Commission (FCC).
(2021, October 12b) Satellite. https://
www.fcc.gov/general/satellite. (FCC,
October 12, 2021b)
Groenewold M et al., (2020, July 10).
Increases in Health-Related Workplace
Absenteeism Among Workers in
Essential Critical Infrastructure
Occupations During the COVID–19
Pandemic—United States, March–April
2020. Centers for Disease Control and
Prevention MMWR Vol. 69, No. 27.
(Groenewold et al., July 10, 2020)
Internal Revenue Service (IRS). (2013). 2013
Corporation Source Book. https://
www.irs.gov/statistics/soi-tax-stats-
corporation-source-book-us-total-and-
sectors-listing. (IRS, 2013)
Jackson S. (2021, August 2). Gyms like
Equinox and SoulCycle will soon require
members to show proof of vaccination to
use their clubs and studios. https://
www.businessinsider.com/equinox-
soulcycle-will-require-covid-19-vaccines-
for-members-staff-2021–8. (Jackson,
August 2, 2021)
NAICS Association. (2018a). NAICS Codes
Description, 2018: 221118—Other
Electric Power Generation. https://
www.naics.com/naics-code-description/
?code=221118. Last accessed October 12,
2021. (NAICS Association, 2018a)
NAICS Association. (2018b). Six Digit NAICS
Codes and Titles, 2018: Codes 48–49.
https://www.naics.com/six-digit-naics/
?code=48-49. Last accessed October 12,
2021. (NAICS Association, 2018b)
NAICS Association. (2018c). Six Digit NAICS
Codes and Titles, 2018: Code 51. https://
www.naics.com/six-digit-naics/
?code=51. Last accessed October 12,
2021. (NAICS Association, 2018c)
NAICS Association. (2018d). NAICS Profile
Page, 2018: Berkshire Hathaway Energy
Co. https://www.naics.com/company-
profile-page/?co=4973. Last accessed
October 12, 2021. (NAICS Association,
2018d)
NAICS Association. (2018e). NAICS Profile
Page, 2018: Dominion Energy Inc.
https://www.naics.com/company-profile-
page/?co=11715. Last accessed October
12, 2021. (NAICS Association, 2018e)
Occupational Safety and Health
Administration (OSHA). (2016, March
24). Final Economic and Regulatory
Flexibility Analysis for OSHA’s Rule on
Occupational Exposure to Respirable
Crystalline Silica, Chapter VI, pp. VI–20.
Docket No. OSHA–2010–0034–4247.
(OSHA, March 24, 2016)
Occupational Safety and Health
Administration (OSHA). (2021a,
October). Analytical Spreadsheets in
Support of the COVID–19 Vaccination
and Testing ETS. (OSHA, October 2021a)
Park S. (2021, January 23). RV sales soar
during coronavirus pandemic. https://
www.foxbusiness.com/lifestyle/rv-sales-
soar-during-pandemic-travel-road-trip.
(Park, January 23, 2021)
U.S. Census Bureau. (2021, October 8a).
Scientific Integrity. https://
www.census.gov/about/policies/quality/
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61504
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
scientific_integrity.html. (US Census
Bureau, October 8, 2021a)
U.S. Census Bureau. (2021, October 8b).
Statement of Commitment to Scientific
Integrity by Principal Statistical
Agencies. https://www.census.gov/
content/dam/Census/about/about-the-
bureau/policies_and_notices/
scientificintegrity/Scientific_Integrity_
Statement_of_the_Principal_Statistical_
Agencies.pdf. (US Census Bureau,
October 8, 2021b)
Walker C. (2013, January 22). Is Tidal Power
a Viable Source of Energy? https://
www.azocleantech.com/article.aspx?
ArticleID=350. (Walker, January 22,
2013)
Washington Utilities and Transportation
Commission (UTC). (2021, October 12).
Eligible Telecommunications Carriers.
https://www.utc.wa.gov/regulated-
industries/utilities/telecommunications/
federal-universal-service-funds/eligible-
telecommunications-carriers. (UTC,
October 12, 2021)
V. Additional Requirements
A. Regulatory Flexibility Act
Whenever an agency is required by
the Administrative Procedure Act, 5
U.S.C. 553, or another law, to publish a
general notice of proposed rulemaking,
the Regulatory Flexibility Act (RFA), 5
U.S.C. 601 et seq., requires the agency
to prepare an initial regulatory
flexibility analysis (IRFA). 5 U.S.C.
601(2), 603(a). Since this ETS ‘‘shall
serve as a proposed rule’’ for a final
standard under section 6(c)(3) of the
OSH Act, it is treated as a general notice
of proposed rulemaking under the RFA.
An agency may waive or defer the IRFA
in the event a rule is promulgated in
response to an emergency that makes
compliance with the requirements of
section 603 impracticable. 5 U.S.C.
608(a). The agency hereby certifies that
compliance with the IRFA requirement
is impracticable under the
circumstances. OSHA prepared this ETS
on an expedited basis in response to a
national emergency affecting the lives
and health of the nation’s workers; the
IRFA is inherently a relatively lengthy
process that would be impracticable to
undertake for a standard of such broad
applicability in the limited time
available. Because OSHA is not
preparing an IRFA for the ETS, the
agency is also not required to convene
a small entity panel under section
609(b).
B. Unfunded Mandates Reform Act
(UMRA), 2 U.S.C. 1501 et seq.
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA),
2 U.S.C. 1532, requires agencies to
assess the anticipated costs and benefits
of a rule before issuing ‘‘any general
notice of proposed rulemaking’’ that
includes a Federal mandate that may
result in expenditures in any one year
by state, local, or Tribal governments, or
by the private sector, of at least $100
million, adjusted annually for inflation.
The assessment requirement also
applies to ‘‘any final rule for which a
general notice of proposed rulemaking
was published.’’ Although no general
notice of proposed rulemaking was
published, the agency has analyzed the
ETS’s economic feasibility and health
impacts in Section IV.B. of this
preamble (Economic Analysis) and
Health Impacts Appendix (OSHA,
October 2021c).
C. Executive Order 13175
Section 5 of E.O. 13175, on
Consultation and Coordination with
Indian Tribal Governments, requires
agencies to consult with tribal officials
early in the process of developing
regulations that: (1) Have tribal
implications, that impose substantial
direct compliance costs on Indian
governments, and that are not required
by statute; or (2) have tribal implications
and preempt tribal law. 65 FR 67249,
67250 (Nov. 6, 2000). E.O. 13175
requires that such consultation occur to
the extent practicable. Given the
expedited nature of issuing the ETS, it
was not practicable for OSHA to consult
and incorporate non-federal input prior
to promulgation of the standard. OSHA
commits to meaningful consultation
with tribal representatives after
publication of the ETS and during the
comment period before finalizing any
permanent standard. Such consultation
will be consistent with the
Administrative Procedure Act.
D. National Environmental Policy Act
OSHA has reviewed this ETS
according to the National
Environmental Policy Act (NEPA) of
1969, 42 U.S.C. 4321 et seq., the
regulations of the Council on
Environmental Quality, 40 CFR chapter
V, subchapter A, and the Department of
Labor’s NEPA procedures, 29 CFR part
11. As a result of this review, the agency
has determined that the rule will have
no significant impact on air, water, or
soil quality; plant or animal life; the use
of land; or other aspects of the external
environment. Although the ETS
contains testing requirements, and test
kits and supplies can generate some
additional materials that will enter the
waste stream, the impact of this ETS
will be minimal. As discussed in more
detail in Technological Feasibility
(Section IV.A. of this preamble), there is
already a surplus of available tests, and
projected production of COVID–19 tests
will be more than sufficient to meet
demands for testing created as a result
of the rule. Therefore, tests used for
purposes of or for compliance with this
ETS are not being produced as a result
of this standard, and the standard will
not generate significant new streams of
waste beyond what would be generated
in the absence of the standard.
E. Congressional Review Act
This ETS is considered a major rule
under the Congressional Review Act
(CRA), 5 U.S.C. 801 et seq. Section
801(a)(3) of the CRA normally requires
a 60-day delay in the effective date of
a major rule. 5 U.S.C. 801(a)(3), 804(2).
However, section 808(2) of the CRA
allows the issuing agency to make a rule
effective sooner than otherwise
provided by the CRA if the agency
makes a good cause finding that notice
and public procedure are impracticable,
unnecessary, or contrary to the public
interest. 5 U.S.C. 808(2). OSHA finds
that there is good cause to make this
rule effective upon publication because
notice and public procedure with
respect to this ETS are both
impracticable and contrary to the public
interest, given the expedited timeline on
which this standard was developed and
the grave danger threatening workers’
lives and health (see Grave Danger and
Need for the ETS, both in Section III. of
this preamble). Congress authorized
OSHA to take swift action in
promulgating an ETS to address this
type of grave danger, and provided
explicitly that an ETS is effective upon
publication, 29 U.S.C. 655(c)(1);
delaying the effective date of such an
expedited process would thwart that
purpose. It is specifically because of the
emergency nature of this rulemaking
that the OSH Act allows for OSHA to
proceed without the extensive public
input the agency normally solicits in
issuing occupational safety and health
standards. 29 U.S.C. 655(c)(1). For rules
to which section 808(2) applies, the
agency may set the effective date. In this
case, consistent with the OSH Act
requirement cited above, the ETS takes
immediate effect upon publication in
the Federal Register.
F. Administrative Procedure Act
The Administrative Procedure Act
(APA) normally requires notice and
comment, and a 30-day delay of the
effective date of a final rule, for
recordkeeping and reporting regulations
promulgated under section 8(c) of the
OSH Act. 29 U.S.C. 657(c); 5 U.S.C.
553(b), (d). This ETS contains
recordkeeping and reporting
requirements tailored to address
COVID–19 illness. To the extent that
these requirements are not already
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exempt from the APA’s requirements for
notice and comment under section 6(c)
of the Act (29 U.S.C. 655(c)), OSHA
invokes the ‘‘good cause’’ exemption to
the APA’s notice requirement because
the agency finds that notice and public
procedure are impracticable and
contrary to the public interest under 5
U.S.C. 553(b)(B). As explained in more
detail in Grave Danger and Need for the
ETS (both in Section III. of this
preamble), this finding is based on the
critical importance of implementing the
requirements in this ETS, including the
recordkeeping and reporting provisions,
as soon as possible to address the grave
danger that COVID–19 presents to
workers.
As noted above, the ETS is required
by the OSH Act to take immediate effect
upon publication. 29 U.S.C. 655(c)(1).
For that reason, and the underlying
public health emergency that prompted
this ETS as discussed above, OSHA
finds good cause to waive the normal
30-day delay in the effective date of a
final rule from the date of its
publication in the Federal Register. See
5 U.S.C. 553(d)(3). OSHA notes,
however, that OSHA does not require
compliance with any provision of the
ETS within the first 30 days after it
becomes effective.
G. Consensus Standards
OSHA must consider adopting an
existing national consensus standard
that differs substantially from OSHA’s
standard if the consensus standard
would better effectuate the purposes of
the Act. See section 12(d)(1) of the
National Technology Transfer and
Advancement Act of 1995 (15 U.S.C.A.
272 Note); see also 29 U.S.C. 655(b)(8).
OSHA considered incorporation of
ASTM F3502–21 in this ETS, as
required. However, the agency has
insufficient evidence to make a general
finding of feasibility at this time. The
agency notes that face coverings that
meet ASTM F3502–21 criteria also meet
the definition of ‘‘face coverings’’ in this
ETS (see the discussion of this issue in
Summary and Explanation, Section VI.
of this preamble). The agency has asked
questions about this topic to gather
additional information.
H. Executive Order 13045
Executive Order 13045, on Protection
of Children from Environmental Health
Risks and Safety Risks, requires that
Federal agencies submitting covered
regulatory actions to OIRA for review
pursuant to Executive Order 12866 must
provide OIRA with (1) an evaluation of
the environmental health or safety
effects that the planned regulation may
have on children, and (2) an explanation
of why the planned regulation is
preferable to other potentially effective
and reasonably feasible alternatives
considered by the agency (62 FR 19885
(April 23, 1997)). Executive Order 13045
defines ‘‘covered regulatory actions’’ as
rules that may (1) be economically
significant under Executive Order
12866, and (2) concern an
environmental health risk or safety risk
that an agency has reason to believe may
disproportionately affect children.
Because OSHA has no reason to believe
that the risk from COVID–19
disproportionately affects children, the
ETS is not a covered regulatory action
and OSHA is not required to provide
OIRA with further analysis under
section 5 of the executive order.
However, to the extent children are
exposed to COVID–19 either as
employees or at home as a result of
family members’ workplace exposures
to COVID–19, the ETS should provide
some protection for children.
I. Federalism
The agency reviewed this ETS
according to Executive Order 13132, on
Federalism, which requires that Federal
agencies, to the extent possible, refrain
from limiting State policy options,
consult with States before taking actions
that would restrict States’ policy
options, and take such actions only
when clear constitutional authority
exists and the problem is of national
scope. 64 FR 43255 (August 10, 1999).
The Executive Order generally allows
Federal agencies to preempt State law
only as provided by Congress or where
State law conflicts with Federal law. In
such cases, Federal agencies must limit
preemption of State law to the extent
possible.
The Occupational Safety and Health
Act is an exercise of Congress’s
Commerce Clause authority, and under
Section 18 of the Act, 29 U.S.C. 667,
Congress expressly provided that States
may adopt, with Federal approval, a
plan for the development and
enforcement of occupational safety and
health standards. OSHA refers to States
that obtain Federal approval for such
plans as ‘‘State Plans.’’ Occupational
safety and health standards developed
by State Plans must be at least as
effective in providing safe and healthful
employment and places of employment
as the Federal standards. As discussed
below, State Plans must submit to
Federal OSHA for approval, standards
that differ from Federal standards
addressing the same issues, in order for
such standards to become part of the
OSHA-approved State Plan. Subject to
these requirements, State Plans are free
to develop and enforce their own
occupational safety and health
standards.
This ETS complies with E.O. 13132.
The problems addressed by this ETS for
COVID–19 are national in scope. As
explained in Grave Danger (Section
III.A. of this preamble), employees face
a grave danger from exposure to
COVID–19 in the workplace. Employees
across the country face the danger of
exposure to COVID–19 at work, and as
explained in Need for the ETS (Section
III.B. of this preamble), a national
standard is needed to protect workers
from the grave danger of COVID–19 by
strongly encouraging vaccination and
limiting the presence of COVID–19
positive workers in the workplace
through testing and to ensure that a
clear and consistent baseline approach
is taken across the country to protect
them. The SARS–CoV–2 virus is highly
communicable and infects workers
without regard to state borders, making
a national approach necessary.
Accordingly, the ETS establishes
minimum requirements for employers
in every State to protect employees from
the risks of exposure to COVID–19.
In States without OSHA-approved
State Plans, Congress provides for
OSHA standards to preempt State
occupational safety and health
standards for issues addressed by the
Federal standards. In these States, this
ETS limits State policy options in the
same manner as every standard
promulgated by the agency.
Furthermore, as discussed in the
Summary and Explanation for Purpose,
nothing in the ETS is intended to limit
generally applicable public health
measures instituted by state or local
governments that go beyond, and are not
inconsistent with, the requirements of
the ETS. (See Summary and
Explanation for Purpose, Section VI.A.
of this preamble); Gade v. National
Solid Wastes Management Ass’n, 505
U.S. 88, 107 (1992). In States with
OSHA-approved State Plans, this ETS
does not significantly limit State policy
options. Any special workplace
problems or conditions in a State with
an OSHA-approved State Plan may be
dealt with by that State’s standard,
provided the standard is at least as
effective as this ETS.
As discussed in the Summary and
Explanation for Purpose in this
preamble, OSHA has included a
provision that states the purpose of this
ETS, as well as OSHA’s intent to
preempt all inconsistent State and local
requirements that relate to the issues
addressed by this ETS. (See section
1910.501(a); Summary and Explanation
for Purpose, Section VI.A. of this
preamble). This includes State and local
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79 The ETS applies to agricultural establishments
with 11 or more employees engaged on any day in
hand-labor occupations in the field and agricultural
establishments that maintain a temporary labor
camp, regardless of how many employees are
engaged on any day in hand-labor occupations in
the field).
requirements banning or limiting the
authority of employers to require
vaccination, face covering, or testing. As
discussed in that section, such State and
local bans would be preempted by this
ETS, even in States with OSHA-
approved State Plans, because such bans
are not approved by federal OSHA as
part of the State Plan and could not be
approved, because such bans are clearly
not as effective—and, indeed, are
contrary to—the federal ETS. See
Indust. Truck Ass’n v. Henry, 125 F.3d
1305, 1311 (9th Cir. 1997).
J. State Plans
When Federal OSHA promulgates an
emergency temporary standard, States
and U.S. Territories with their own
OSHA-approved occupational safety
and health plans (‘‘State Plans’’) must
either amend their standards to be
identical or ‘‘at least as effective as’’ the
new standard, or show that an existing
State Plan standard covering this area is
‘‘at least as effective’’ as the new Federal
standard. 29 CFR 1953.5(b). This ETS
imposes new requirements to protect
workers across the nation from COVID–
19. Adoption of this ETS, or an ETS that
is at least as effective as this ETS, by
State Plans must be completed within
30 days of the promulgation date of the
final Federal rule, and State Plans must
notify Federal OSHA of the action they
will take within 15 days. The State Plan
standard must remain in effect for the
duration of the Federal ETS. As noted
above in Federalism (Section V.I. of this
preamble), this ETS preempts all State
and local requirements, including in
States with State Plans, that ban or limit
the authority of employers to require
vaccination, face covering, or testing.
(See also the Summary and Explanation
for Purpose, Section VI.A. of this
preamble). As with all non-identical
State Plan standards, OSHA will review
any comparable State standards to
determine whether they are at least as
effective as this ETS. A State Plan
standard that prohibits employers from
requiring vaccination would not be at
least as effective as this ETS because
OSHA has recognized in this ETS that
vaccination is the most protective policy
choice for employers to adopt to protect
their workplaces.
Of the 28 States and Territories with
OSHA-approved State Plans, 22 cover
both public and private-sector
employees: Alaska, Arizona, California,
Hawaii, Indiana, Iowa, Kentucky,
Maryland, Michigan, Minnesota,
Nevada, New Mexico, North Carolina,
Oregon, Puerto Rico, South Carolina,
Tennessee, Utah, Vermont, Virginia,
Washington, and Wyoming. The
remaining six States and Territories
cover only state and local government
employees: Connecticut, Illinois, Maine,
New Jersey, New York, and the Virgin
Islands.
K. Paperwork Reduction Act
I. Overview
The Emergency Temporary Standard
(ETS) for COVID–19 Vaccination and
Testing contains collection of
information requirements that are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(PRA), 44 U.S.C. 3501, et seq., and
OMB’s regulations at 5 CFR part 1320.
The PRA defines a collection of
information to mean the obtaining,
causing to be obtained, soliciting, or
requiring the disclosure to third parties
or the public, of facts or opinions by or
for an agency, regardless of form or
format (44 U.S.C. 3502(3)(A)). OSHA
has determined an ETS is necessary to
protect workers from the grave danger
posed by COVID–19 and is issuing an
ETS that amends 29 CFR 1910 subpart
U to provide COVID–19 protections to
workers of employers with 100 or more
employees. Section 1910.501 contains
collections of information necessary to
effectuate the purpose of the ETS. The
collections of information appear in
paragraphs 1910.501(d), (e)(2), (e)(4),
(f)(1), (g)(1), (g)(4), (h)(1), (j), (k)(1),
(k)(2), (l)(1), and (l)(2). For a more
comprehensive discussion of these
provisions, see the sectional analysis
earlier in this preamble. These
information collections are applied by
cross reference to other industries in
regulations 29 CFR 1915.1501 (Shipyard
Employment), 1917.31 (Marine
Terminals), 1918.110 (Longshoring),
1926.58 (Construction), 1928.21
(Agriculture).79
Under the PRA, a Federal agency
cannot conduct or sponsor a collection
of information unless OMB approves it
and the agency displays a currently
valid OMB control number (44 U.S.C.
3507). Notwithstanding any other
provision of law, if a collection of
information does not display a currently
valid control number, an employer shall
not be subject to penalty for failing to
comply with the collection of
information (44 U.S.C. 3512). The PRA
has special provisions for emergency
situations that are applicable to this
ETS. OMB may authorize a collection of
information without regard to the
normal clearance procedures if either (a)
the relevant agency determines that the
collection of information is essential to
the mission of the agency and public
harm is reasonably likely to result if
normal clearance procedures are
followed, or (b) the use of normal
clearance procedures is reasonably
likely to cause a statutory or court
ordered deadline to be missed (44
U.S.C. 3507(j) and 5 CFR 1320.13).
Because COVID–19 presents an ongoing
public health threat to workers and
American businesses, OSHA has
requested the use of these emergency
procedures for this ETS. In accordance
with 44 U.S.C. 3507(j)(1), OMB
approved the request and assigned this
ETS an OMB control number that is
valid for 180 days. Therefore, the
information collection provisions
contained within this ETS will take
effect at the same time as all other
provisions.
II. Summary of Information Collection
Requirements
This information collection is
summarized as follows.
1. Title: COVID–19 Vaccination and
Testing Emergency Temporary Standard
(29 CFR 1910, subpart U; 1915, subpart
Z; 1917, subpart B; 1918, subpart K;
1926, subpart D; 1928, subpart B).
2. Type of Review: Emergency.
3. OMB Control Number: 1218–0278.
4. Affected Public: This rule applies to
employers with a total of 100 or more
employees except where the workplace
is covered under the Safer Federal
Workforce Task Force COVID–19
Workplace Safety: Guidance for Federal
Contractors and Subcontractors; or in
setting where the employee provides
healthcare services or healthcare
support services that falls under the
requirements of 29 CFR 1910.502. This
rule does not apply to employees of
covered employers who work from
home, exclusively outdoors, or who do
not report to a workplace where other
individuals such as coworkers or
customers are present.
5. Description of the ICR. This ICR
contains collections of information
requirements for employers with 100 or
more employees. The employer must
establish, implement, and enforce a
written mandatory vaccination policy
that requires each employee to be fully
vaccinated against COVID–19 unless the
employer implements a policy that
allows employees to choose between
being fully vaccinated or both tested
and wearing a face covering. Employers
must determine employee vaccination
status, and must require than any
employees who are not vaccinated be
tested for COVID–19 at least once every
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80 The Court held that the dual impact licensing
statutes were preempted; however, no rationale
commanded a majority. A four-justice plurality
found that supplementary State regulation is
impliedly preempted. Id. at 98–99. Justice
Kennedy’s concurrence would have found express
preemption rather than implied preemption, Id. at
110–111, but otherwise agreed that ‘‘in the OSH
statute Congress intended to pre-empt
supplementary state regulation.’’ Id. at 113.
7 days. Employers must provide
specified information to employees
regarding COVID–19 vaccine efficacy,
safety, and the benefits of being
vaccinated, and must maintain a record
of the COVID–19 vaccination status,
proof of vaccination, and copies of
employee COVID–19 test results, and
the aggregate number of fully vaccinated
employees at a workplace along with
the total number of employees at that
workplace.
6. Number of respondents: 1,858,935.
7. Frequency: Varies.
8. Number of Responses: 205,262,803.
9. Estimated Burden Hours:
79,720,444.
10. Estimated Cost (Capital-operation
and maintenance): $1,383,751,520.
These totals are explained and
supported in the agency’s Supporting
Statement as required by the PRA.
III. Request for Comment
Although the ETS takes effect
immediately, with implementation
dates specified in the Dates provision of
this publication, it also serves as a
temporary standard that can only be
made permanent following an
opportunity for public notice and
comment. OSHA therefore invites the
public to submit comments to OSHA on
the proposed collections of information
with regard to the following.
• Whether the proposed collections of
information are necessary for the proper
performance of the Agency’s functions,
including whether the information is
useful.
• The accuracy of OSHA’s estimate of
the burden (time and cost) of the
collections of information, including the
validity of the methodology and
assumptions used.
• The quality, utility, and clarity of
the information collected.
• Ways to minimize the compliance
burden on employers, for example, by
using automated or other technological
techniques for collecting and
transmitting information.
Please submit comments related to the
Paperwork Act analysis to OSHA in the
PRA docket (Docket Number OSHA–
2021–0008). Comments related to other
parts of the ETS should be submitted to
the rulemaking docket (Docket Number
OSHA–2021–0007). OSHA will accept
comments for 60 days on the
information collection aspects of the
rule. For instructions on submitting
these comments to the rulemaking and/
or PRA docket, see the sections of this
Federal Register notice titled DATES and
ADDRESSES.
References
Occupational Safety and Health
Administration (OSHA). (2021c,
October). Health Impacts of the COVID–
19 Vaccination and Testing ETS. (OSHA,
October 2021c)
VI. Summary and Explanation
A. Purpose
The ETS includes a sentence that
states the purpose of the rule. The first
part of the sentence in the paragraph
indicates that the standard addresses the
grave danger of COVID–19 in the
workplace by establishing workplace
vaccination, vaccination verification,
face covering and testing requirements.
The second part of the sentence
addresses the preemption of State and
local laws, regulations, executive orders,
and other requirements, by this Federal
standard. It indicates OSHA’s intention
that the ETS address comprehensively
the occupational safety and health
issues of vaccination, wearing face
coverings, and testing for COVID–19,
and thus that the standard is intended
to preempt States, and political
subdivisions of States, from adopting
and enforcing workplace requirements
relating to these issues, except under the
authority of a Federally-approved State
Plan. In particular, OSHA intends to
preempt any State or local requirements
that ban or limit an employer’s authority
to require vaccination, face covering, or
testing.
Preemption of such State and local
requirements derives from section 18 of
OSH Act and general principles of
conflict preemption. See Gade v.
National Solid Wastes Management
Ass’n, 505 U.S. 88 (1992).80 Gade
clarified two important principles. First,
section 18 expresses Congress’ intent to
preempt State workplace safety or
health laws relating to issues on which
Federal OSHA has promulgated
occupational safety and health
standards. Under section 18, a State can
avoid preemption of such laws only if
it submits and receives Federal approval
for a State Plan for the development and
enforcement of standards. OSHA-
approved State Plans operate under
authority of State law and must adopt
occupational safety and health
standards which, among other things,
must be at least as effective in providing
safe and healthful employment and
places of employment as Federal
standards. 29 U.S.C. 667.
Second, State and local laws that do
not constitute occupational safety or
health laws because they are ‘‘laws of
general applicability’’ that regulate
workers and nonworkers alike are
preempted only if they conflict with the
federal standard. Laws of general
applicability that are consistent with the
federal standard are not preempted.
Gade, 505 U.S. at 107.
While section 18 applies to every
occupational safety and health standard
that OSHA promulgates, this ETS raises
particular concerns because of the
current landscape of existing State and
local requirements that may overlap
with, or directly conflict with, the
requirements of this ETS. As discussed
in Need for the ETS (Section III.B. of
this preamble), OSHA is adopting this
ETS in response to an unprecedented
health crisis that has resulted in a global
pandemic severely impacting the health
and wellbeing of people in the United
States, and globally. This ETS is issued
based on OSHA’s determination that
employees in the United States face a
grave danger from workplace exposures
to SARS–CoV–2, that the ETS is
necessary to protect those workers, and
that the measures for vaccination,
vaccine verification, face coverings, and
testing that this ETS requires will help
ensure that workers covered by the ETS
are protected from severe illness and
death resulting from contracting
COVID–19 in the workplace.
As explained in Need for the ETS
(Section III.B. of this preamble), the lack
of a national standard on this hazard has
led to disparate State and local
requirements, and this underscores the
need for OSHA’s ETS to provide clear
and consistent protection to employees
across the country. Over the past
months, an increasing number of States
have passed laws or enacted other
requirements banning workplace
vaccination policies that would
mandate vaccination or require proof of
vaccination status, thus prohibiting
employers operating in those
jurisdictions from implementing this
proven method of protecting workers
from the hazard of COVID–19 that is at
the core of this ETS (see, e.g., Texas
Executive Order GA–40, October 11,
2021; Montana H.B. 702, July 1, 2021;
Arkansas S.B. 739, October 4, 2021 and
Arkansas H.B. 1977, October 1, 2021;
AZ Executive Order 2021–18, Aug. 16,
2021). While some States’ bans have
focused on preventing local
governments from requiring their public
employees to be vaccinated or show
proof of vaccination, the Texas,
Montana, and Arkansas requirements
apply to private employers as well.
Likewise, some States and localities
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81 The express purposes of such requirements
banning or limiting employers from requiring
vaccination, face coverings, or testing may often not
relate to occupational safety and health. For
example, Governor Greg Abbott’s Texas face
covering mandate ban in Executive Order GA–16,
is based on alleged decreasing COVID–19 rates and
the need to alleviate ‘‘confusion,’’ (Texas Executive
Order GA–36, May 18, 2021); the stated purpose of
Montana’s vaccination mandate ban is to address
health care privacy interests (Montana H.B. 702,
July 1, 2021).
have enacted requirements that prohibit
businesses, government offices, schools
or other public spaces from requiring
that face coverings be worn (see, e.g.,
Florida Executive Order 21–102, May 3,
2021; Texas Executive Order GA–34,
March 2, 2021; Texas Executive Order
GA–36, May 18, 2021). State and local
requirements that prohibit employers
from implementing employee
vaccination mandates, or from requiring
face coverings in workplaces, serve as a
barrier to OSHA’s implementation of
this ETS, and to the protection of
America’s workforce from this deadly
virus.
As discussed below, state restrictions
of this kind are clearly preempted
whether they take the form of direct
workplace regulation or are part of a law
of general applicability because they
relate to the issues addressed by this
standard and conflict with it. Gade, 505
U.S. at 99, 107. As is also discussed
below, this is true even for State or local
requirements that may not prevent
employers from compliance with the
ETS, but that prescribe or limit the
employer’s ability to mandate
vaccination for its workforce as the
employer’s chosen means of
compliance. See Gade, 505 at 107; see
also Geier v. American Honda, 529 U.S.
861, 869, 875–886 (2000) (finding
Department of Transportation (DOT)
regulations preempted a State tort action
where the state action ‘‘upset the careful
regulatory scheme established by federal
law’’ and placing weight on DOT’s
interpretation that such tort suit would
be ‘‘an obstacle to the accomplishment
and execution’’ of Agency objectives).
An employer’s choice to mandate
vaccination is a critical aspect of this
ETS, and state laws that remove that
choice conflict with it.
Thus, to ensure that the ETS
supplants the existing State and local
vaccination bans and other
requirements that could undercut its
effectiveness, and to foreclose the
possibility of future bans, OSHA has
clearly defined the issues addressed by
this section to encompass vaccination,
face covering, and testing needed to
protect against transmission of COVID–
19 to employees in the workplace. To
avoid ambiguity, OSHA has stated
expressly that it intends this ETS to
preempt all State and local workplace
requirements that ‘‘relate’’ to these
issues, except pursuant to a State Plan.
29 U.S.C. 667(b).
The ‘‘unavoidable implication’’ of
section 18 is that because OSHA has
adopted this ETS, States may no longer
regulate these issues except with
OSHA’s approval and the authority of a
Federally-approved State Plan. Gade,
505 U.S. at 99. As the Court explained,
section 18 preempts States without
approved plans from adopting or
enforcing any laws that constitute, ‘‘in
a direct, clear and substantial way
regulation of worker health and safety’’
relating to an issue addressed by an
OSHA standard. Id. at 107.
State and local requirements that ban
or otherwise limit workplace
vaccination, face covering, or testing
clearly ‘‘relate’’ to the occupational
safety and health ‘‘issues’’ that OSHA is
regulating in this ETS. 29 U.S.C. 667(b).
Such bans regulate key workplace
COVID–19 protections that are
encompassed by this ETS ‘‘in a direct,
clear and substantial way.’’ Gade, 505
U.S. at 107. The direct effect of such
bans is to prohibit employers from
requiring employees to implement
measures, such as vaccination
requirements, face coverings, or testing.
These workplace protective measures
are covered by, and, in many
circumstances required by, this ETS. For
example, vaccination mandate bans
directed at employers specifically bar
them from requiring employee
vaccination requirements for the
purposes of protecting their workforce.
Prohibitions on face covering mandates
likewise directly prohibit individuals in
positions of authority, including
employers, from requiring face covering
use.
Although the expressly stated
purposes for State and local
requirements banning or limiting
employers from requiring vaccinations,
face coverings, or testing may not be
occupational safety and health,81 this
does not control their preemption under
section 18 of the OSH Act. In assessing
State and local requirements’ impact on
a federal statutory scheme, courts ‘‘have
refused to rely solely on the legislature’s
professed purpose and have looked as
well to the effects of the law.’’ Gade, 505
U.S. at 105; see also, e.g., Perez v.
Campbell, 402 U. S. 637, 651–652 (1971)
(‘‘[A]ny state legislation which frustrates
the full effectiveness of federal law is
rendered invalid by the Supremacy
Clause’’); Napier v. Atlantic Coast Line
R. Co., 272 U.S. 605, 612 (1926) (pre-
emption analysis does not depend on
whether federal and State laws ‘‘are
aimed at distinct and different evils’’
but whether they ‘‘operate upon the
same object’’).
That a State has articulated a purpose
other than, or in addition to, workplace
health and safety would not divest the
OSH Act of its preemptive force,
because preemption law looks to the
effects as well as the purpose of a State
law, and thus a dual-impact State law
cannot avoid OSH Act preemption
simply because the regulation serves
several objectives. Gade, 505 U.S. at 107
(holding ‘‘a law directed at workplace
safety is not saved from pre-emption
simply because the State can
demonstrate some additional effect
outside of the workplace’’ and ‘‘[t]hat
such law may also have a
nonoccupational impact does not render
it any less of an occupational standard
for purposes of pre-emption analysis’’).
Thus, to the extent that the stated
purpose of a requirement that bans or
limits employers from requiring
vaccinations, face coverings, or testing
is something other than, or in addition
to, occupational health, such laws,
which have a specific and direct impact
on worker health, are nevertheless
preempted.
Further, section 18 preempts even
‘‘nonconflicting’’ State and local
occupational safety and health
requirements relating to the issues
addressed by this standard. Gade, 505
U.S. at 98–99, 103; see id. at 100 (‘‘state
laws regulating the same issue as federal
laws are not saved, even if they merely
supplement the federal standard’’). This
is because OSHA ‘‘’pre-empts the field’
for any nonapproved State law
regulating the same safety and health
issue.’’ See Gade, 505 U.S. at 104, n. 2,
citing English v. General Electric. Co.,
496 U.S. 72, 79–80, n.5 (‘‘[F]ield
preemption may be understood as a
species of conflict pre-emption: A State
law that falls within a pre-empted field
conflicts with Congress’ intent (either
express or plainly implied) to exclude
state regulation’’); see also id. at 105
(discussing effect of field preemption).
See generally Geier, 529 U.S. at 869,
875–886 (finding State law preemption
where it ‘‘upset the careful regulatory
scheme established by federal law’’);
Williamson v. Mazda Motor of Am., Inc.,
562 U.S. 323, 330–36 (2011) (affirming
the conflict pre-emption principle that
‘‘a state law that stands as an obstacle
to the accomplishment and execution of
the full purposes and objectives of a
federal law is pre-empted’’ and finding
preemption where State law interfered
with ‘‘significant objective’’ of the
federal regulation).
For example, the ETS would preempt
State or local governments from
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82 OSHA is aware that some States have adopted
or are considering adopting such requirements,
which this ETS would preempt (see, e.g., Arkansas
S.B. 739, October 4, 2021 and Arkansas H.B. 1977,
October 1, 2021, which Arkansas Governor Asa
Hutchinson allowed to became law without his
signature, and which require employers in Arkansas
to allow employees to opt out of vaccination for
purposes of complying with federal vaccination
requirements; see also Governor Hutchinson,
October 13, 2021; Marr, October 7, 2021 (describing
the Arkansas legislation and noting that other states
may contemplate similar legislation)).
83 OSHA’s Cranes and Derricks in Construction
rule directly discussed its expectations and intent
regarding the preemptive effect of the rule,
including that it was not intended to preempt
generally applicable municipal regulations, such as
building codes, which serve public safety purposes.
Cranes and Derricks in Construction, 75 FR 47,906,
48,128 (August 9, 2010). This rule also includes a
provision that requires employers to comply with
State crane operator licensing requirements that
meet the federal floor for crane operator
certification in the rule. 29 CFR 1926.1427(c)(1).
OSHA has also indicated that its rule would not
preempt State or local requirements in other
rulemakings. See e.g., 72 FR 7136, 7188 (Feb. 14,
2007) (Preamble to OSHA’s most recent electrical
safety standard) (‘‘State and local fire and building
codes, which are designed to protect a larger group
of persons than employees,’’ are not preempted); 29
CFR 1910.134(e) (requiring compliance with State
and local laws by requiring ‘‘a licensed health care
professional’’ to perform a medical evaluation of an
employee’s ability to use a respirator).
dictating that employers adopt a scheme
of testing and face coverings that
complies with 1910.501(g) and (i) of the
ETS, but that bars employers from
electing the preferred vaccine mandate
alternative in paragraph (d), because
this interferes with OSHA’s significant
regulatory objectives and its preemption
of the field.82 (See Need for the ETS
(Section III.B. of this preamble)
discussing that vaccination is the
preferred compliance option under this
rule because it is the most effective
method of protecting workers from
COVID–19). Likewise, the ETS would
preempt such State or local
occupational requirements, even to the
extent that they may regulate employers
with fewer than 100 employees,
notwithstanding that the requirements
in this ETS only apply to employers
with more than 100 employees.
Case law is instructive on this point.
In Gade, the Supreme Court found
regulations implementing a State statute
that required training for workers
handling hazardous waste that went
beyond, but did not conflict with,
OSHA’s hazardous waste training
requirements to be preempted by the
OSHA requirements. Id. Likewise, in
Industrial Truck Association
Incorporated v. Henry, the Ninth Circuit
found that OSHA’s hazard
communication standard preempted
California’s Hazard Communication
regulations that were not submitted to
OSHA for approval through its State
Plan, even to the extent that California’s
Hazard Communication rule regulated
manufacturers and distributers who
were excluded from coverage under
federal OSHA’s rule. Indust. Truck
Ass’n v. Henry, 125 F.3d 1305, 1311–14
(9th Cir. 1997). In the same way, the
ETS preempts all State and local
requirements that bar or limit the ability
of an employer to require workplace
vaccination, testing, and face coverings
to protected employees against COVID–
19 in any respect, since OSHA has
occupied the entire field of regulation
on these issues.
OSHA’s definition of the ‘‘issue’’ in
this rule should be afforded weight,
since the OSH Act vests OSHA with
standard-setting responsibility and,
therefore, the authority to determine
which ‘‘issues’’ to address with
occupational safety and health
standards. See Indust. Truck, 125 F.3d
at 1311 (relying on OSHA’s regulation
and statements in the preamble to
identify the relevant ‘‘issue’’ for
preemption purposes in OSHA’s Hazard
Communication standard).
Importantly, although OSHA’s stated
intention is to preempt conflicting State
and local requirements relating to the
issues addressed by this standard,
OSHA recognizes that the OSH Act does
not allow, and OSHA does not intend,
for the ETS to preempt non-conflicting
State or local requirements of general
applicability. In Gade, the Supreme
Court qualified its ruling by saving from
preemption non-conflicting State and
local ‘‘laws of general applicability
(such as laws regarding traffic safety or
fire safety) that do not conflict with
OSHA standards and that regulate the
conduct of workers and nonworkers
alike.’’ Gade, 505 U.S. at 107. The
Majority reasoned that, ‘‘[a]lthough
some laws of general applicability may
have a ‘direct and substantial’ effect on
worker safety, they cannot fairly be
characterized as ‘occupational’
standards, because they regulate
workers simply as members of the
general public.’’ Id.
During the pandemic, many States
and municipal governments have
adopted requirements intended to
protect public health by helping to
prevent the spread of COVID–19 in
public spaces. These have included
requirements mandating face coverings
in indoor public spaces, including
businesses, government buildings, and
schools (see, e.g., Baltimore City Health
Department, August 10, 2021; Illinois
Executive Order 2021–20, August 26,
2021; Hawai’i Emergency Proclamation,
October 1, 2021). In addition, in recent
months, some States and municipal
governments have adopted requirements
mandating that members of the public
provide proof of vaccination or recent
COVID–19 testing in order to enter
restaurants, bars, or other businesses or
public spaces (see, e.g., NYC Emergency
Executive Order 225, August 16, 2021
(mandating COVID–19 vaccination for
most individuals for indoor
entertainment, recreation, dining and
fitness settings)). Requirements such as
these apply to ‘‘workers and nonworkers
alike’’ and ‘‘regulate workers simply as
member of the general public’’ and are
accordingly not preempted. Gade, 505
U.S.at 107.
Based on OSHA’s observations and
experience during the past year and a
half that the pandemic has been
ongoing, OSHA is confident that
protective State and local regulations of
general applicability that mandate face
coverings or vaccination will
complement, rather than interfere with
OSHA’s enforcement of the ETS, and
also does not intend to preempt such
requirements. Indeed, OSHA believes
that such measures have significantly
reduced the harmful effects of the
pandemic and total fatalities. See Steel
Institute of NY v. The City of NY, 716
F.3d 31, 38 (affording some weight to
OSHA’s view that municipal regulations
governing construction cranes did not
interfere with OSHA’s regulatory
scheme in its crane standards and
ultimately adopted OSHA’s view in
finding these municipal regulations
were not preempted by OSHA crane
standards).83
In Steel Institute, the Second Circuit
held that OSHA’s crane regulations did
not preempt New York City municipal
regulations governing construction
cranes, finding that such regulations
were requirements of general
applicability, notwithstanding their
direct bearing on worker safety, because
their primary purpose and effect was to
preserve the safety of the general public,
and they regulated workers and
nonworkers alike. Id. The Steel Institute
court noted the ‘‘strong presumption
against preemption when states and
localities ‘‘exercise[ ] their police
powers to protect the health and safety
of their citizens.’’ Id. at 36, citing
Medtronic, Inc. v. Lohr, 518 U.S. 470,
475 (1996). The Second Circuit was also
influenced by the clear danger
presented to the public by unsafe crane
operation. This is analogous to the
situation here, because exposure to
COVID–19 is a hazard that directly
impacts everyone. Thus, generally
applicable State and local mandates
requiring face coverings or vaccination
should not be preempted and should
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84 In addition, some State and local governments
have adopted vaccination mandates directed at
State and/or local government employees. The OSH
Act and OSHA’s standards would not preempt such
requirements since State or local government
employers and employees are exempt from OSHA
coverage under the OSH Act. 29 U.S.C. 652 (5)
(defining employer to exclude ‘‘any State or
political subdivision of a State’’). However, many
State and local government employers in States
with OSHA-approved State Plans will be covered
by State occupational safety and health
requirements, and State Plans must adopt
requirements for State and local government
employers, as well as covered private sector
employers, that are at least as effective as federal
OSHA’s requirements; State Plans may also choose
to adopt more protective occupational safety and
health requirements. 29 U.S.C. 667(c).
85 As previously discussed, bans on mandating
vaccinations or face coverings have not typically
been generally applicable, but even the least
workplace-specific, most generally applied bans
will not survive preemption because they directly
interfere with the ETS’s regulatory scheme.
86 For example, Arizona has an OSHA-approved
State Plan, but its vaccination ban, which is not part
of its State Plan, is preempted by this ETS (see AZ
Executive Order 2021–18, Aug. 16, 2021).
remain in effect, notwithstanding this
ETS.84
On the other hand, as noted above,
this standard will preempt requirements
that conflict with it, regardless of
whether the requirements are part of a
law of general applicability.85
The effect of the ETS on State law
requirements in State Plan States works
somewhat differently. As previously
noted, under section 18 of the OSH Act
States that wish to assume
responsibility for the development and
enforcement of ‘‘occupational safety and
health standards relating to any
occupational safety or health issue with
respect to which a Federal standard has
been promulgated’’ may submit a State
Plan to OSHA for approval. Id. section
667(b); see also id. section 667(c)
(describing requirements for OSHA
approval of State Plans on issues for
which OSHA has adopted standards).
There are 22 States and territories that
have OSHA-approved State Plans for
private employers, and 6 additional
States and territories that have OSHA-
approved State Plans for public
employers only.
Under section 18(c)(2) of the OSH
Act, State Plans are required to adopt
and enforce occupational safety and
health standards that are at least as
effective as federal OSHA’s
requirements. Id. section 667(c)(2). In
addition, the OSH Act requires that
State Plans must cover State and local
government employees (including, e.g.,
State and local school systems within
the scope of this rule), even though
federal OSHA does not have coverage
over such employees in States without
OSHA-approved State Plans.
Once OSHA promulgates an ETS,
OSHA’s regulations provide that those
States have ‘‘30 days after the date of
promulgation of the Federal standard to
adopt a State emergency temporary
standard,’’ or to demonstrate ‘‘that
promulgation of an emergency
temporary standard is not necessary
because the State standard is already the
same or at least as effective as the
Federal standard change.’’ 29 CFR
1953.5(b)(1). The new ETS becomes part
of the OSHA-approved State Plan
through the State Plan’s submission to
OSHA documentation showing it
adopted an identical ETS or a ‘‘Plan
Change Supplement’’ showing that it
has adopted requirements that are ‘‘at
least as effective’’ as federal OSHA’s
ETS. 29 CFR 1953.5(b)(3); 1953.4.
Even in States with OSHA-approved
State Plans, any State law relating to an
occupational safety and health issue
that OSHA regulates is preempted
unless it is submitted for OSHA’s
approval as a supplement to the State
Plan. Indust. Truck Ass’n, 125 F.3d at
1311 (‘‘If a State wishes to regulate an
issue of worker safety for which a
federal standard is in effect, its only
option is to obtain the prior approval of
the Secretary of Labor . . . [and] [i]t
would make the state plan approval
requirement superfluous if a state could
pick and choose which occupational
health and safety regulations to submit
to OSHA’’). Thus, a State or local
requirement banning or limiting
employer vaccine mandates would
similarly be preempted because it has
not been approved by federal OSHA as
part of the State Plan. And, indeed, it
could not be approved by federal OSHA,
because such bans or limitations
undercut the ETS’s requirements and
are clearly not as effective as the federal
ETS. See 29 U.S.C. 667(c)(2).86
Finally, this provision includes a note
that this section establishes minimum
requirements for employers, that
nothing in this section prevents
employers from agreeing with their
employees to implement additional
measures, and that this section does not
supplant collective bargaining
agreements or other collectively
negotiated agreements in effect that may
have negotiated terms that exceed the
requirements herein. It also references
the National Labor Relations Act of
1935, which protects most private-sector
employees’ right to take collective
action. The purpose of this note is to
remind employers and employees that
OSHA’s ETS establishes a floor for
protections, and that it does not
preclude bargaining for additional
protective measures. For example,
employers might agree to cover the costs
of face coverings or medical removal, or
to a requirement that all employees,
regardless of vaccination status, wear
face coverings while working indoors.
References
An Act Prohibiting Discrimination Based on
a Person’s Vaccination Status or
Possession of an Immunity Passport;
Montana H.B. 702. (2021, July 1). https://
leg.mt.gov/bills/2021/billpdf/
HB0702.pdf. (Montana H.B. 702, July 1,
2021)
Arizona Executive Order 2021–18. (2021,
August 16). https://azgovernor.gov/sites/
default/files/eo_2021–18.pdf. (AZ
Executive Order 2021–18, August 16,
2021)
Arkansas H.B. 1977. (2021, October 1). To
Provide Employee Exemptions From
Federal Mandates and Employer
Mandates Related to Coronavirus 2019
(COVID–19); and to Declare an
Emergency. https://
www.arkleg.state.ar.us/Bills/
FTPDocument?path=%
2FAMEND%2F2021R%2FPublic%
2FHB1977–H1.pdf. (Arkansas H.B. 1977,
October 1, 2021)
Arkansas S.B. 739. (2021, October 4). An Act
Concerning Employment Issues Related
to Coronavirus 2019 (COVID–19); To
Provide Employee Exemptions From
Federal Mandates and Employer
Mandates Related to Coronavirus 2019
(COVID–19); To Declare and Emergency;
and For Other Purposes. https://
www.arkleg.state.ar.us/Bills/
FTPDocument?path=%
2FBills%2F2021R%
2FPublic%2FSB739.pdf. (Arkansas S.B.
739, October 4, 2021)
Arkansas Governor Asa Hutchinson. (2021,
October 13). Press Release: Governor
Hutchinson Allows Vaccine Mandate,
Redistricting Bills to Become Law
Without His Signature. https://governor.
arkansas.gov/news-media/press-
releases/governor-hutchinson-allows-
vaccine-mandate-redistricting-bills-to-
become-la. (Governor Hutchinson,
October 13, 2021)
Baltimore City Health Department. (2021,
August 10). Health Commissioner
Updated Directive and Order for Face
Coverings. https://www.baltimore
city.gov/sites/default/files/HEALTH%20
COMMISSIONER%
20AUGUST%2010,%202021%
20DIRECTIVE%20AND%
20ORDER%20FOR%
20FACE%20COVERINGS_FINAL.pdf.
(Baltimore City Health Department,
August 10, 2021)
Emergency Executive Order 225. (2021,
August 16). Key to NYC: Requiring
COVID–19 Vaccination for Indoor
Entertainment, Recreation, Dining and
Fitness Settings. https://www1.nyc.gov/
office-of-the-mayor/news/225–001/
emergency-executive-order-225. (NYC
Emergency Executive Order 225, August
16, 2021)
Florida Executive Order 21–102. (2021, May
3). https://www.flgov.com/wp-content/
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87 If OSHA receives information suggesting that a
broader scope would be appropriate, the agency
could expand the scope of the ETS quickly through
a supplemental action. Fla. Peach Growers Ass’n,
Inc. v. U. S. Dep’t of Labor, 489 F.2d 120, 127 (5th
Cir. 1974) (‘‘It is inconceivable that Congress,
having granted the Secretary the authority to react
quickly in fast-breaking emergency situations,
intended to limit his ability to react to
developments subsequent to his initial response.’’)
uploads/orders/2021/EO_21–102.pdf.
(Florida Executive Order 21–102, May 3,
2021)
Hawai’i Emergency Proclamation Related to
the State’s COVID–19 Delta Response.
(2021, October 1). https://governor.
hawaii.gov/wp-content/uploads/2021/
10/2109152–ATG_Emergency-
Proclamation-Related-to-the-States-
COVID–19-Delta-Response-distribution-
signed.pdf. (Hawai’i Emergency
Proclamation, October 1, 2021)
Illinois Executive Order 2021–20. (2021,
August 26). https://www.illinois.gov/
government/executive-orders/executive-
order.executive-order-number-
20.2021.html. (Illinois Executive Order
2021–20, August 26, 2021)
Marr C. (2021, October 7). Workplace
Vaccine Exemption Bills Sent to
Arkansas Governor. Bloomberg Law.
https://news.bloomberglaw.com/daily-
labor-report/workplace-vaccine-
exemption-bills-sent-to-arkansas-
governor. (Marr, October 7, 2021)
Texas Executive Order GA–34. (2021, March
2). Executive Order No. GA–34 relating
to the opening of Texas in response to
the COVID–19 disaster. https://
open.texas.gov/uploads/files/
organization/opentexas/E.O.-GA–34-
opening-Texas-response-to-COVID-
disaster-IMAGE–03–02–2021.pdf. (Texas
Executive Order GA–34, March 2, 2021)
Texas Executive Order GA–36. (2021, May
18). Executive Order No. GA–36 relating
to the prohibition of governmental
entities and officials from mandating
face coverings or restricting activities in
response to the COVID–19 disaster.
https://gov.texas.gov/uploads/files/
press/E.O.-GA–36_prohibition_on_
mandating_face_coverings_response_to_
COVID–19_disaster_IMAGE_05–18–
2021.pdf. (Texas Executive Order GA–
36, May 18, 2021)
Texas Executive Order GA–40. (2021,
October 11). Executive Order No. GA–40
relating to prohibiting vaccine mandates,
subject to legislative action. https://
gov.texas.gov/uploads/files/press/E.O.-
GA–40_prohibiting_vaccine_mandates_
legislative_action_IMAGE_10–11–
2021.pdf. (Texas Executive Order GA–
40, October 11, 2021)
B. Scope and Application
Paragraph (b)(1) of this ETS provides
that the ETS applies to all employers
that have a total of at least 100
employees at any time the ETS is in
effect. OSHA has determined that the
unvaccinated employees of these
employers face a grave danger of
exposure to SARS–CoV–2, including the
Delta variant, while they are at work
(see Grave Danger, Section III.A. of this
preamble). Because this grave danger
finding applies to all unvaccinated
employees who come into contact with
other people in indoor work settings as
part of their employment, this ETS is
not limited by industrial sector or
NAICS code. Therefore, this standard
generally covers employers in all
workplaces that are under OSHA’s
authority and jurisdiction, including
industries as diverse as manufacturing,
retail, delivery services, warehouses,
meatpacking, agriculture, construction,
logging, maritime, and healthcare.
I. Decision To Limit Coverage of This
ETS to Employers With 100 or More
Employees
This ETS applies to employers with a
total of 100 or more employees at any
time the standard is in effect. In light of
the unique occupational safety and
health dangers presented by COVID–19,
and against the backdrop of the
uncertain economic environment of a
pandemic, OSHA established this
coverage threshold for four reasons.
First, OSHA is confident that employers
with 100 or more employees will be able
to meet the standard’s requirements
promptly, as the emergency addressed
by the standard necessitates. OSHA is
less confident that smaller employers
can do so without undue disruption.
Second, this coverage threshold will
enable the standard to reach two-thirds
of all private-sector workers in the
nation, providing them with prompt
protection. Third, the standard will
reach the largest facilities, where the
most deadly outbreaks of COVID–19 can
occur. Fourth, the 100-employee
threshold in this standard is comparable
with the size thresholds established by
congressional and agency decisions in
analogous contexts.
a. Challenges to Feasibility Analysis for
Small Businesses
An OSHA standard, including an
ETS, must be both economically and
technologically feasible. A standard is
economically feasible under the OSH
Act if it neither threatens ‘‘massive
dislocation to’’ nor upsets the
‘‘competitive stability of’’ the regulated
industries. United Steelworkers of Am.,
AFL–CIO–CLC v. Marshall, 647 F.2d
1189, 1265 (D.C. Cir. 1980).
Technological feasibility has been
interpreted broadly to mean ‘‘capable of
being done’’ Am. Textile Mfrs. Inst. v.
Donovan, 452 U.S. 490, 509–510 (1981).
As shown in Economic Analysis,
Section IV.B. of this preamble, OSHA is
confident that this standard is feasible
for employers with 100 or more
employees. OSHA is not at this time
making any determination about
whether it would be appropriate to
extend the ETS to cover smaller
employers. Put simply, the agency is
requiring that employers it is confident
can implement the provisions of the
standard without delay do so. At the
same time, the agency is soliciting
public comment and seeking additional
information to assess the ability of
smaller employers to do so in the
rulemaking commenced by this ETS.
OSHA will determine the issue on the
basis of the record, after receiving
public comment.87 The SARS–CoV–2
virus continues to spread rapidly, and
each day that passes, tens of thousands
more people are infected. The
employees of larger firms should not
have to wait for the protections of this
standard while OSHA takes the
additional time necessary to assess the
feasibility of the standard for smaller
employers.
The pandemic has presented special
challenges for small businesses.
According to a survey conducted during
its early stages, 66% of businesses with
fewer than 100 employees had suffered
revenues losses exceeding 30%. (SHRM,
May 6, 2020a). By contrast, only 27% of
larger businesses with more than 100
employees had seen revenue drops of
more than 30% (SHRM, May 6, 2020b).
More recently, 61% of the members of
the National Federation of Independent
Businesses, mostly very small
businesses, responded to a survey
reported that they were experiencing
staff shortages, with half of that group
reporting a moderate to significant loss
of sales because of unfilled positions
(NFIB, July 12, 2021).
The requirements of the ETS could
have a differential impact on small
businesses compared with larger firms.
Many small businesses lack separate
human resources departments and
struggle to carry out HR functions. A
study found that some 70% of small
businesses (with 5 to 49 employees)
handle HR tasks in an ad hoc way.
(ADP, December 2016). Only 23% of ad
hoc managers believed they had the
tools and resources necessary to perform
HR tasks well, and only 19% were fully
confident in their ability to handle HR
tasks without making mistakes (ADP,
December 2016). Another survey found
that HR functions are proportionally far
more expensive for smaller firms than
for larger (small firms defined as up to
250 workers) (SHRM, 2015). The ETS
requires employers to establish new
systems to track vaccination status
among workers, to keep related records,
and for firms that allow the testing
option, to keep records of each test.
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88 See, e.g., Oregon Health Authority, October 6,
2021, (publishing data on outbreaks in large
workplaces including two Amazon facilities,
several hospitals, and a Walmart distribution
center); CDPHE, Oct. 6, 2021, (identifying an active
Covid outbreak in Cargill’s Fort Morgan, CO meat
processing plant, which employs more than 2,000
workers). While some have speculated that clusters
of infections among employees at the same facility
might result initially from shared exposures outside
of work, the original source of the infection would
have little bearing on the statistical probability of
exposure and transmission once the infected people
are together in the workplace with unvaccinated co-
workers. The most effective way to prevent further
transmission is to protect the other workers through
vaccination or, when that is not possible, identify
and remove the infected workers from the
workplace as quickly as possible.
These records must be treated as
confidential medical records subject to
detailed regulations, which is not
something most smaller employers
typically need to do or have existing
systems in place to address. 29 CFR
1910.1020. While OSHA has imposed
similar requirements on smaller
employers before, it has typically done
so in highly regulated industries, such
as healthcare, or in industries involving
complicated industrial processes, which
already require a certain degree of
administrative capacity even when not
responding to a grave danger, through a
rulemaking process that provides
additional time for notice and
implementation, and when there is
more time to assess the impact that the
standard would have on small business.
This emergency standard by contrast
applies across the board to all
industries, including less regulated
retail and service sectors.
Moreover, OSHA estimates that some
5% of employees may have a medical
contraindication or request an
accommodation from the rule’s
requirements for disability or sincerely
held religious belief reasons. (Please see
Economic Analysis, Section IV.B. of this
preamble). Assessing these requests may
require more resources for smaller firms
with less experience in this area,
particularly if they lack HR staff. By the
same token, a delay in applying the ETS
to businesses with fewer than 100
employees would allow those
businesses the benefit of learning from
the models established by larger
businesses with respect to
accommodations. Similarly,
implementing the ETS’s testing
provisions in a stepwise fashion will
allow OSHA the time necessary to
assess any impact the new requirements
may have on the testing infrastructure
and related supply chains before
considering extending those
requirements to additional employers.
b. The ETS Provides Prompt Protection
for Most of America’s Workforce
The 100 employee threshold means
the ETS will reach two-thirds of the
nation’s private sector workforce,
providing protection to millions of
workers while issues regarding smaller
firms are reviewed. OSHA considered
that a 100 employee threshold was
superior to a 150 employee threshold in
this respect, because it would protect
more employees: 67% rather than 63%,
which is a difference of 4.856 million
workers. (U.S. Census Bureau, May
2021). And while a 50 employee
threshold would have covered more
employees (78%), it would have
required additional feasibility analysis,
while still leaving many employees
outside the standard. (U.S. Census
Bureau, May 2021).
c. The ETS Will Help Prevent Large
Outbreaks of COVID–19
The ETS’s focus on employers with
more than 100 employees will also help
prevent large-scale outbreaks. As
addressed in more detail in the
discussion of Grave Danger (Section
III.A. of this preamble), all unvaccinated
employees who work in indoor settings
face a grave danger from COVID–19,
which is why the scope of the ETS is
not limited to worksites of a specific
size. The standard is based on employer
size primarily because administrative
capacity is more closely related to
employer size. In addition, employer
size provides a clear measure that is
easy for employers (and OSHA) to track,
as opposed to an alternative such as a
workplace-based approach, which could
fluctuate from day to day and mean
more places and information for the
employer to track. But OSHA also chose
the 100 employee size threshold in
recognition of the fact that larger
employers are more likely to have many
employees gathered in the same
location. For employers with 100 or
more employees, the median number of
employees at any one location is
approximately 50 (the average is also
50). (U.S. Census Bureau, May 2021).
For employers with fewer than 100
employees, the median number of any
one location is approximately 2 (with an
average number of 7) (U.S. Census
Bureau, May 2021).
Employees at larger locations are
statistically more likely to be exposed to
someone with COVID–19 during the
course of their shifts, and thus face a
heightened risk of virus transmission.
Studies indicate that introduction of
infection and the risk of infection
transmission is increased with the size
of a gathering (Champredon et al., April,
2021), and with larger populations
(Shacham et al., July 5, 2021). See also
(Contreras et al., July, 2021) (concluding
that outbreaks were larger and lasted
longer at facilities with more onsite
staff). It is therefore not surprising that
significant COVID–19 outbreaks have
occurred at large facilities of employers
with 100 or more employees 88 (Oregon
Health Authority, October 6, 2021;
CDPHE, October 6, 2021). A study of
outbreaks in Los Angeles County found
that the median number of employees in
an establishment in which an outbreak
occurred was 95, well above the 50
employee median for locations of
employers covered by this rule,
indicating that the rule will protect
employees in the places where
outbreaks are most likely to occur.
(Contreras et al., July, 2021). And those
outbreaks occurred even before the
emergence of the SARS–CoV–2 Delta
variant, which the CDC says ‘‘causes
more infections and spreads faster than
early forms of SARS–CoV–2.’’ (CDC,
August 26, 2021) In fact, the studies
noted earlier in this paragraph were
published just as the Delta variant was
emerging, meaning that the risk of
transmission cited in those studies has
likely increased.
While virus transmission is certainly
not limited to large facilities, the
potential scope of an outbreak is
inherently more limited when fewer
employees are present. In limiting the
scope of the ETS to employers with 100
or more employees, OSHA is
prioritizing coverage of those businesses
in which the spread of the virus could
potentially affect the largest number of
employees and for which the agency is
most confident that it is feasible to
apply the standard.
d. Analogous Regulatory Regimes Use
Comparable Employee Size Thresholds
Congress and federal agencies have
frequently recognized that an employee
size threshold may be appropriate in
different regulatory contexts. They have
not settled on any one number as the
most appropriate, presumably because
that depends on balancing different
considerations that are relevant to the
particular context, as OSHA has done
here. But several analogous regulatory
regimes use employee size thresholds
comparable to the one selected here, in
light of similar concerns about
administrative feasibility.
For example, the EEOC has issued
regulations requiring employers with
100 or more employees to submit
annual reports related to equal
employment opportunity in their
workforce, in recognition that larger
employers are better equipped to absorb
the types of administrative burdens
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imposed by surveying, tracking and
recordkeeping requirements. See 42
U.S.C. 2000e–8(c), 29 CFR 1602.7–.14
and 41 CFR 60–1.7(a). In earlier
measures adopted in response to the
COVID–19 pandemic, Congress adopted
special protections and exemptions
based on employee counts. The Families
First Coronavirus Response Act, Public
Law 116–127 (2020), sections 7001 and
7003 provided tax credits to businesses
with fewer than 500 employees to assist
compliance with the Act’s expansion of
paid sick and family leave, in
recognition of the challenges facing
smaller employers. Congress again
relied on the same 500 employee
threshold when it later extended tax
credits only to employers who granted
employees paid time off to be
vaccinated, implicitly acknowledging
the financial obstacles that can exist for
smaller employers for the same activity
that this ETS promotes (and without the
vaccine policy and verification
requirement in this ETS). American
Rescue Plan Act, Public Law 117–2, Sec.
9641 (2021).
In the Affordable Care Act, Congress
set the maximum size of a ‘‘small
employer’’ at 100 employees for
purposes of allowing greater flexibility
to these employers. 42 U.S.C.A.
18024(b)(3). Likewise, private
employers with fewer than 50
employees are exempt from complying
with the Family and Medical Leave Act,
in recognition of smaller employers’
decreased administrative capacity, as
well as their inability to easily
accommodate employee absences. 29
U.S.C.A. 2611(2)(b)(2).
e. The 100 Employee Coverage
Provision Is a Reasonable Exercise of the
Secretary’s Authority
OSHA’s choice of a 100 employee
threshold is based on balancing the
fundamentally incommensurable
considerations described above. Under
the statute OSHA ‘‘shall’’ issue an ETS
when employees are exposed to grave
danger, and is not to follow normal
notice and comment procedures to build
a record. 29 U.S.C. 655(e). But OSHA
may not issue an ETS unless it shows
that the rule is feasible for the
employers covered, and it has not yet
made a feasibility determination for
smaller employers. In the circumstances
of this case, OSHA considered that an
ETS was urgently needed to protect
employees, that a 100 employee
threshold would protect the great
majority of them and prevent the largest
outbreaks, that it would avoid the
delays that would be needed if the
agency were required to gather
information and analyze feasibility for
smaller employers, and that a
comparable size threshold has been
found appropriate in similar contexts.
Where employees are dying every day,
it is not unreasonable for the agency to
prioritize doing what it can to address
the problem quickly, regardless of
whether there are further actions it
might be able to take later.
Doing so implements the statutory
delegation of authority to the agency to
establish priorities for issuing standards
by giving ‘‘due regard to the urgency of
the need’’ for standards for particular
workplaces. 29 U.S.C. 655(g). The courts
have recognized that this provision
authorizes the Secretary to make
reasonable decisions limiting the scope
of a standard, particularly where as here
the agency has said it will address the
reserved issue in subsequent
rulemaking. Forging Indus. Assoc. v.
Donovan, 773 F.2d 1436, 1454 (4th Cir.
1985) (hearing conservation standard);
United Steelworkers of Am. v. Marshall,
647 F.2d 1189, 1309–1310 (D.C. Cir.
1980) (lead standard).
Where competing considerations are
in play and there is no clear perfect
choice, OSHA has a degree of discretion
to draw a reasonable line. Courts have
consistently recognized that agencies
have discretion to draw reasonable
lines. As the D.C. Circuit has explained:
An agency has ‘‘wide discretion’’ in
making line-drawing decisions and
‘‘[t]he relevant question is whether the
agency’s numbers are within a zone of
reasonableness, not whether its numbers
are precisely right.’’ WorldCom, Inc. v.
FCC, 238 F.3d 449, 462 (D.C. Cir. 2001)
(quotation marks omitted). An agency
‘‘is not required to identify the optimal
threshold with pinpoint precision. It is
only required to identify the standard
and explain its relationship to the
underlying regulatory concerns.’’ Id. at
461–62. Nat’l Shooting Sports Found. v.
Jones, 716 F.3d. 200, 214–215 (D.C. Cir
2013). See also Providence Yakima Med.
Ctr. v. Sebelius, 611 F.3d 1181, 1190–
1191 (9th Cir. 2010).
For the reasons discussed above, the
balance the agency struck here falls well
within this zone of reasonableness.
II. Explanation of Who Is Included in
the 100-Employee Threshold
The applicability of this ETS is based
on the size of an employer, in terms of
number of employees, rather than on the
type or number of workplaces. In
determining the number of employees,
employers must include all employees
across all of their U.S. locations,
regardless of employees’ vaccination
status or where they perform their work.
Part-time employees do count towards
the company total, but independent
contractors do not. As discussed above,
OSHA has not found that the standard
is feasible for firms with fewer than 100
employees, because it needs additional
time to assess the impact of the standard
on these employers, particularly as
many smaller firms lack separate human
resources departments and may face
additional challenges when carrying out
human resources functions. In contrast,
OSHA has determined that the standard
is feasible for firms with 100 or more
employees, regardless of where those
employees report to work. These firms
generally have greater administrative
capacities, and including all such
employers in the scope of this ETS
ensures that OSHA can cover two-thirds
of all workers in the private sector as
quickly as possible.
For a single corporate entity with
multiple locations, all employees at all
locations are counted for purposes of
the 100-employee threshold for coverage
under this ETS. In a traditional
franchisor-franchisee relationship in
which each franchise location is
independently owned and operated, the
franchisor and franchisees would be
separate entities for coverage purposes,
such that the franchisor would only
count ‘‘corporate’’ employees, and each
franchisee would only count employees
of that individual franchise. In other
situations, two or more related entities
may be regarded as a single employer
for OSH Act purposes if they handle
safety matters as one company, in which
case the employees of all entities
making up the integrated single
employer must be counted.
In scenarios in which employees of a
staffing agency are placed at a host
employer location, only the staffing
agency would count these jointly
employed workers for purposes of the
100-employee threshold for coverage
under this ETS. Although the staffing
agency and the host employer would
normally share responsibility for these
workers under the OSH Act, this ETS
raises unique concerns in that OSHA
has set the threshold for coverage based
primarily on administrative capacity for
purposes of protecting workers as
quickly as possible, as discussed above,
and the staffing agency would typically
handle administrative matters for these
workers. Thus, for purposes of the 100-
employee threshold, only the staffing
agency would count the jointly
employed employees. The host
employer, however, would still be
covered by this ETS if it has 100 or more
employees in addition to the employees
of the staffing agency. For enforcement
purposes, traditional joint employer
principles would apply where both
employers are covered by the ETS, as
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89 Note that, in addition to the scope exceptions
contained in the ETS itself, which are discussed in
this section, there may be situations where the ETS
does not apply by operation of the OSH Act. For
example, the OSH Act does not apply to working
conditions of employees with respect to which
other Federal agencies have exercised their
statutory authority to prescribe or enforce standards
or regulations affecting occupational safety or
health (see 29 U.S.C. 653(b)(1)). Moreover, the ETS
does not apply where states with OSHA-approved
occupational safety and health programs (‘‘State
Plans’’) have coverage (see 29 U.S.C. 667). State
Plans must adopt and enforce COVID–19
requirements that are at least as effective as this
ETS. Finally, the ETS does not apply to state and
local government employers in states without State
Plans (see 29 U.S.C. 652(5)).
illustrated further by the examples
below. See also https://www.osha.gov/
temporaryworkers/.
On a typical multi-employer worksite
such as a construction site, each
company represented—the host
employer, the general contractor, and
each subcontractor—would only need to
count its own employees, and the host
employer and general contractor would
not need to count the total number of
workers at each site. That said, each
employer must count the total number
of workers it employs regardless of
where they report for work on a
particular day. Thus, for example, if a
general contractor has more than 100
employees spread out over multiple
construction sites, that employer is
covered under this ETS even if it does
not have 100 or more employees present
at any one worksite. Covering the
employees of larger employers at multi-
employer worksites would mitigate the
spread of COVID–19 at the workplace
even where not all employees are
covered by this ETS because fully
vaccinated employees (or unvaccinated
employees wearing face coverings and
submitting to weekly testing) would be
less likely to spread the virus to
unvaccinated workers at the site who
are not covered by this ETS.
The determination as to whether a
particular employer is covered by the
standard should be made separately
from whether individual employees are
covered by the standard’s requirements,
as described by paragraph (b)(3) (e.g.,
some employers may be covered but
have no duties with respect to some of
their employees under this standard).
Some additional examples include:
• If an employer has 75 part-time
employees and 25 full-time employees,
the employer would be within the scope
of this ETS because it has 100
employees.
• If an employer has 150 employees,
100 of whom work from their homes
full-time and 50 of whom work in the
office at least part of the time, the
employer would be within the scope of
this ETS because it has more than 100
employees.
• If an employer has 102 employees
and only 3 ever report to an office
location, that employer would be
covered.
• If an employer has 150 employees,
and 100 of them perform maintenance
work in customers’ homes, primarily
working from their company vehicles
(i.e., mobile workplaces), and rarely or
never report to the main office, that
employer would also fall within the
scope.
• If an employer has 200 employees,
all of whom are vaccinated, that
employer would be covered.
• If an employer has 125 employees,
and 115 of them work exclusively
outdoors, that employer would be
covered.
• If a single corporation has 50 small
locations (e.g., kiosks, concession
stands) with at least 100 total employees
in its combined locations, that employer
would be covered even if some of the
locations have no more than one or two
employees assigned to work there.
• If a host employer has 80
permanent employees and 30 temporary
employees supplied by a staffing
agency, the host employer would not
count the staffing agency employees for
coverage purposes and therefore would
not be covered. (So long as the staffing
agency has at least 100 employees,
however, the staffing agency would be
responsible for ensuring compliance
with the ETS for the jointly employed
workers.)
• If a host employer has 110
permanent employees and 10 temporary
employees from a small staffing agency
(with fewer than 100 employees of its
own), the host employer is covered
under this ETS and the staffing agency
is not.
• If a host employer has 110
permanent employees and 10 employees
from a large staffing agency (with more
than 100 employees of its own), both the
host employer and the staffing agency
are covered under this standard, and
traditional joint employer principles
apply.
• Generally, in a traditional
franchisor-franchisee relationship, if the
franchisor has more than 100 employees
but each individual franchisee has fewer
than 100 employees, the franchisor
would be covered by this ETS but the
individual franchises would not be
covered.
As explained earlier, part of OSHA’s
rationale in adopting the 100-employee
threshold is to focus the ETS on
companies that OSHA is confident will
have sufficient administrative systems
in place to comply quickly with the
ETS. Thus, the ETS applies to all
employers who have the requisite
number of employees at any time this
ETS is in effect. Along with employers
that always have more than 100
employees, OSHA intends to cover
employers that fluctuate above and
below the 100-employee threshold
during the term of the ETS because
those employers will typically have
already developed systems and
capabilities for compliance; a decrease
in the number of employees is therefore
unlikely to make them less capable of
compliance.
The determination of whether an
employer falls within the scope of this
ETS based on number of employees
should initially be made as of the
effective date of the standard, as set out
in paragraph (m)(1). If the employer has
100 or more employees on the effective
date, this ETS applies for the duration
of the standard. If the employer has
fewer than 100 employees on the
effective date of the standard, the
standard would not apply to that
employer as of the effective date.
However, if that same employer
subsequently hires more workers and
hits the 100-employee threshold for
coverage, the employer would then be
expected to come into compliance with
the standard’s requirements. Once an
employer has come within the scope of
the ETS, the standard continues to
apply for the remainder of the time the
standard is in effect, regardless of
fluctuations in the size of the
employer’s workforce. For example, an
employer that has 103 employees on the
effective date of the standard, but then
loses four within the next month, would
continue to be covered by the ETS.
OSHA is confident that employers with
100 or more employees at any point
while this ETS is in effect have the
administrative capacity to comply with
the ETS, even if the number of
employees fluctuates somewhat above
and below 100.
Paragraph (b)(2) of this ETS sets forth
two exemptions to the standard.89
Under paragraph (b)(2)(i), this ETS does
not apply to workplaces covered by the
Safer Federal Workforce Task Force
COVID–19 Workplace Safety: Guidance
for Federal Contractors and
Subcontractors (see Safer Federal
Workforce Task Force, September 24,
2021). With limited exceptions, such as
where a medical contraindication,
disability, or sincerely held religious
belief would prevent an employee from
complying with certain provisions,
those guidelines require covered
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contractors to ensure that all covered
contractor employees (1) are fully
vaccinated by December 8, 2021; (2)
follow CDC guidelines for masks and
physical distancing, including masking
and distancing requirements based on
the employee’s vaccination status and
the level of community transmission of
COVID–19 where the workplace is
located; and (3) designate a person to
coordinate COVID–19 workplace safety
efforts at covered workplaces. Because
covered contractor employees are
already covered by the protections in
those guidelines, OSHA has determined
that complying with this standard in
addition to the federal contractor
guidelines is not necessary to protect
covered contractor employees from a
grave danger posed by COVID–19.
Although there may be some respects in
which the OSHA standard is somewhat
more protective, such as providing paid
leave for vaccination, the federal
contractor guidelines are somewhat
more protective in other respects, such
as requiring vaccination for everyone
who does not have a right to an
accommodation rather than allowing
employees to submit to testing in lieu of
vaccination. In essence, they are similar
but slightly different schemes that
provide roughly equivalent protection,
and OSHA has determined that
imposing a second set of similar
protections on covered federal
contractors by subjecting them to this
ETS in addition to the federal contractor
guidance is not necessary at this time to
reduce a grave danger to covered
contractor employees from COVID–19.
Under Executive Order 14043, every
federal agency must implement a
program requiring each of its federal
employees to be vaccinated against
COVID–19, except as required by law.
86 FR 50989. OSHA will regard a
federal agency’s compliance with this
requirement, and the related Safer
Federal Workforce Task Force guidance
issued under section 4(e) of Executive
Order 13991 and section 2 of Executive
Order 14043 (including guidance on
employer support in the form of paid
time for vaccination and paid leave for
post-vaccination recovery), as sufficient
to meet its obligation to comply with
this ETS under Section 19 of the OSH
Act and Executive Order 12196. In
essence, the federal government has
chosen the mandatory vaccination
option of this rule, and all federal
employees are required to be fully
vaccinated by the compliance date of
this standard, except where entitled to
a reasonable accommodation. The Safer
Federal Workforce Task Force’s
guidelines for vaccination verification
are consistent with the ETS’s (see Safer
Federal Workforce Task Force, October
11, 2021). Note, however, that under the
OSH Act, the U.S. Postal Service is
treated as a private employer, see 29
U.S.C. 652(5), and it is therefore
required to comply with this ETS in the
same manner as any other employer
covered by the Act.
For similar reasons, paragraph
(b)(2)(ii) provides that this ETS does not
apply in settings where any employee
provides healthcare services or
healthcare support services while they
are covered by the requirements of 29
CFR 1910.502. Section 1910.502
requires a multi-layered suite of
protections for employees covered by its
requirements, including patient
screening and management, facemasks
or respirators, other personal protective
equipment (PPE), limiting exposure to
aerosol-generating procedures, physical
distancing, physical barriers, cleaning,
disinfection, ventilation, health
screening and medical management,
access to vaccination, and medical
removal protection. Section 1910.502
was carefully tailored to the healthcare
workplaces it covers and, given the full
suite of protections it requires,
including (like this ETS) the provision
of paid time for vaccination, OSHA has
determined that it adequately protects
the employees covered by its
requirements from the grave danger
posed by COVID–19. Therefore,
complying with the additional
requirements of this ETS is not
necessary to protect those employees
while they are covered by that
standard’s protections.
OSHA’s intent was to leave no
coverage gaps between section 1910.502
and this ETS. In other words, the
purpose of paragraph (b)(2)(ii) is to
ensure that all workers in healthcare
and healthcare support jobs who are at
grave danger from exposure to SARS-
CoV–2 are protected by either section
1910.502 or this ETS while performing
their jobs. Therefore, it will be necessary
for employers with employees covered
by section 1910.502 to determine if they
also have employees covered by this
ETS. For example, a healthcare
employer with more than 100
employees that has non-hospital
ambulatory care facilities that are
exempt under section 1910.502(a)(2)(iii)
(for non-hospital ambulatory care
settings where all non-employees are
screened prior to entry and those with
suspected or confirmed COVID–19 are
prohibited from entry) would be
required to protect the employees in
those ambulatory care facilities under
this ETS. Similarly, a retail pharmacy
chain that operates a series of
ambulatory care clinics embedded in its
stores, where those embedded clinics
are the only areas in the store that are
covered under 1910.502 (see section
1910.502(a)(3)(i)), would have to ensure
that the remainder of its employees in
other parts of its stores are protected
under this ETS if the company has 100
or more employees company-wide,
including those covered under
1910.502.
Paragraph (b)(3) provides that, even
where the standard applies to a
particular employer, its requirements do
not apply to employees: (i) Who do not
report to a workplace where other
individuals such as coworkers or
customers are present; (ii) while
working from home; or (iii) who work
exclusively outdoors. OSHA intends
these provisions to exempt workplace
settings where workers do not interact
indoors with other individuals, and to
exempt work performed in the
employee’s home regardless of whether
other individuals may be present in the
home.
OSHA has determined that the
provisions of this ETS are not necessary
to protect employees from COVID–19
when they are working alone, or when
they are working from home (see Grave
Danger, Section III.A. of this preamble).
These two provisions may overlap in
some cases, but also can apply to
slightly different situations. Paragraph
(b)(3)(i) would apply to work in a
solitary location, such as a research
station where only one person (the
employee) is present at a time. In that
situation, the employee is not exposed
to any potentially infectious individuals
at work. Paragraph (b)(3)(ii) would
apply to employees working in their
homes, regardless of whether other
individuals who are not employees of
the same employer are present. In a
home telework environment, many
factors—such as the presence of family
members and other individuals
unrelated to the employee’s work, who
may not be fully vaccinated or wearing
face coverings—may be beyond the
employer’s control. Employees are
typically in the best position to manage
COVID–19 risks in their homes. Note
that the exemption in paragraph
(b)(3)(ii) only applies to employees
while they are working from home. An
employee who switches back and forth
from teleworking to working in a setting
where other people are present (e.g., an
office) is covered by this ETS and must
be vaccinated if required by the
employer. If the employer does not
require vaccination, the teleworking
employee must either be vaccinated or
complete testing and wear a face
covering in accordance with their
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employer’s policy under paragraph (d).
How often such an employee must be
tested for COVID–19 and wear a face
covering, however, depends on how
often they report to the office (see, e.g.,
paragraph (g)(1)(ii)).
Paragraph (b)(3)(iii) provides that,
even if a particular employer is covered
by the standard, the requirements of the
standard do not apply to employees
who work exclusively outdoors. OSHA
has determined that COVID–19 does not
pose a grave danger to employees who
work exclusively outdoors because of
the significantly reduced likelihood of
transmission in outdoor settings. As
discussed in more detail in Grave
Danger (Section III.A. of this preamble),
the record contains very little evidence
of COVID–19 transmission in outdoor
settings. And, in studies where clusters
were identified in worksites
characterized as being outdoors, the
study authors were not able to identify
specific incidents that led to
transmission. In addition, workplaces
characterized as ‘‘outdoors’’ may in fact
involve significant time spent indoors.
For example, on a construction site,
workers inside a partially complete
structure are not truly outdoors, and
some individuals on a construction site
may spend significant amounts of time
in a construction trailer where other
individuals are present. Workers at
outdoor locations may also routinely
share work vehicles. These indoor
exposures could account for COVID–19
clusters among employees at worksites
otherwise characterized as being
outdoors. And employees whose
outdoor time is interrupted by the
indoor periods will still be subject to the
requirements in this ETS.
Studies of athletic teams further
indicate that evidence of COVID–19
clusters among workers characterized as
working outdoors could actually be
caused by indoor exposures. Even
where athletes were in very close
contact during outdoor exposures on the
playing field, the study authors could
not identify a single case of COVID–19
transmission between teams that
occurred outdoors (see Mack et al.,
January 29, 2021; Egger et al., March 18,
2021; Jones et al., February 11, 2021).
For all of these reasons, and as
discussed more fully in Grave Danger
(Section III.A. of this preamble), OSHA
has determined that COVID–19 does not
pose a grave danger to employees who
work exclusively outdoors.
As a practical matter, determining the
applicability of paragraph (b)(3)(iii)
depends on the working conditions of
individual employees. For example, if a
landscaping contractor has at least 100
employees and is not covered by the
exemptions in paragraph (b)(2), the
standard applies to that employer even
if a majority of the company’s
employees work exclusively outdoors.
The standard’s protections would only
apply to employees working in indoor
settings around other individuals (other
than telework in their own homes), not
to those employees working exclusively
outdoors. In some cases, it may be true
that the standard applies to an employer
but the employer would not have to
implement its provisions at all because
all of its employees fall within
exemptions in paragraph (b)(3). Going
back to the example of the large
landscaping contractor, if all indoor
workers either work from home or in
locations where no other individuals are
present, and all outdoors workers work
exclusively outdoors and do not drive to
worksites together in a company
vehicle, the employer would be covered
by the ETS but not required to comply
with its provisions.
An employee will only be covered by
the exemption in paragraph (b)(3)(iii) if
the employee works exclusively
outdoors. Thus, an employee who works
indoors on some days and outdoors on
other days would not be exempt from
the requirements of this ETS. Likewise,
if an employee works primarily
outdoors but routinely occupies
vehicles with other employees as part of
work duties, that employee is not
covered by the exemption in paragraph
(b)(3)(iii). However, if an employee
works outdoors for the duration of every
workday except for de minimis use of
indoor spaces where other individuals
may be present—such as a multi-stall
bathroom or an administrative office—
that employee would be considered to
work exclusively outdoors and covered
by the exemption under paragraph
(b)(3)(iii) as long as time spent indoors
is brief, or occurs exclusively in the
employee’s home (e.g., a lunch break at
home). Extremely brief periods of
indoor work would not normally expose
employees to a high risk of contracting
COVID–19; however, OSHA will look at
cumulative time spent indoors to
determine whether that time is de
minimis. Thus, if there are several brief
periods in a day when an employee goes
inside, OSHA will total those periods of
time when determining whether the
exception for exclusively outdoors work
applies.
Finally, to qualify for this exception,
the employee’s work must truly occur
‘‘outdoors,’’ which would not include
buildings under construction where
substantial portions of the structure are
in place, such as walls and ceiling
elements that would impede the natural
flow of fresh air at the worksite.
Workplaces that are truly outdoors
typically do not include any of the
characteristics that normally enable
transmission of SARS–CoV–2 to occur,
such as poor ventilation, enclosed
spaces, and crowding. As discussed in
Bulfone et al. (November 29, 2020), the
lower risk of transmission in outdoor
settings (i.e., open air or structures with
only one wall) is likely due to increased
ventilation with fresh air and a greater
ability to maintain physical distancing
(see Grave Danger, Section III.A. of this
preamble, for more information on risk
of transmission outdoors).
References
Always Designing for People (ADP). (2016,
December). Opportunity is calling.
Answer it. Insights and solutions for
moving beyond risky ad hoc HR
management. (ADP, December 2016)
Bulfone TC et al. (2020, November 29).
Outdoor Transmission of SARS-CoV–2
and Other Respiratory Viruses: A
Systematic Review. (2020). The Journal
of Infectious Diseases 223: 550–561.
https://doi.org/10.1093/infdis/jiaa742.
(Bulfone et al., November 29, 2020)
Centers for Disease Control and Prevention
(CDC). (2021, August 26). Delta Variant:
What We Know About the Science.
https://www.cdc.gov/coronavirus/2019-
ncov/variants/delta-variant.html?s_
cid=11512:cdc%20delta%20variant:sem.
ga:p:RG:GM:gen:PTN:FY21. (CDC,
August 26, 2021)
Champredon D et al. (2021, May 12).
Modelling approach to assessing risk of
transmission of SARS-CoV–2 at
gatherings. https://www.canada.ca/en/
public-health/services/reports-
publications/canada-communicable-
disease-report-ccdr/monthly-issue/2021-
47/issue-4-april-2021/assessing-risk-
transmission-sars-cov-2-gatherings.html.
(Champredon et al., May 12, 2021)
Colorado Department of Public Health and
Environment (CDPHE). (2021, October
6). CDPHE COVID–19 outbreak map
updated October 6, 2021. https://
cdphe.maps.arcgis.com/apps/
webappviewer/index.html?id=
dcc0b993632a4bc68dc7b9a1dd015cfe.
(CDPHE, October 6, 2021)
Contreras Z et al. (2021, July). Industry
Sectors Highly Affected by Worksite
Outbreaks of Coronavirus Disease, Los
Angeles County, California, USA, March
19-September 30, 2020. Emerg Infect Dis.
2021; 27(7): 1769–1775. doi:10.3201/
eid2707.210425. (Contreras et al., July,
2021)
Egger F et al. (2021, March 18). Does playing
football (soccer) lead to SARS–CoV–2
transmission?—a case study of 3 matches
with 19 infected football players. Science
and Medicine in Football. doi:10.1080/
24733938.2021.1895442. (Egger et al.,
March 18, 2021)
Jones B et al. (2021, February 11). SARS–
CoV–2 transmission during rugby league
matches: do players become infected
after participating with SARS–CoV–2
VerDate Sep<11>2014
22:27 Nov 04, 2021
Jkt 256001
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90 Test sensitivity indicates the ability of a test to
correctly identify people who have a disease. Test
specificity indicates the ability of a test to correctly
identify people who do not have a disease. A test
with high sensitivity and high specificity minimizes
inaccurate results.
positive players? Br J Sports Med
doi:10.1136/bjsports-2020–103714.
(Jones et al., February 11, 2021)
Mack CD et al. (2021, January 29).
Implementation and evolution of
mitigation measures, testing, and contact
tracing in the national football league,
August 9–November 21, 2020. MMWR
70: 130–135. doi:http://dx.doi.org/
10.15585/mmwr.mm7004e2. (Mack et al.,
January 29, 2021)
National Federation of Independent Business
(NFIB) Research Center. (2021, July 12).
Covid-19 small business survey (18):
federal small business programs, the
vaccine, labor shortage, and supply
chain disruptions. https://
assets.nfib.com/nfibcom/Covid-19-18-
Questionnaire.pdf. (NFIB, July 12, 2021)
Oregon Health Authority. (2021, October 6).
COVID–19 weekly outbreak report—
October 6, 2021. https://
www.oregon.gov/oha/covid19/
Documents/DataReports/Weekly-
Outbreak-COVID-19-Report.pdf. (Oregon
Health Authority, October 6, 2021)
Safer Federal Workforce Task Force. (2021,
September 24). COVID–19 Workplace
Safety: Guidance for Federal Contractors
and Subcontractors. https://
www.saferfederal/workforce./gov/
downloads/Draft%/20contractor%/
20guidance%/20doc_20210922.pdf.
(Safer Federal Workforce Task Force,
September 24, 2021)
Safer Federal Workforce Task Force. (2021,
October 11). Vaccinations: Vaccination
Documentation and Information. https://
www.saferfederalworkforce.gov/faq/
vaccinations/. (Safer Federal Workforce
Task Force, October 11, 2021)
Shacham E et al. (2021, July 5). Examining
the relationship between COVID–19
vaccinations and reported incidence.
doi:https://doi.org/10.1101/
2021.06.30.21259794. (Shacham et al.,
July 5, 2021)
Society for Human Resource Management
(SHRM). (2015). How organizational staff
size influences HR metrics. https://
www.shrm.org/resourcesandtools/
business-solutions/documents/
organizational%20staff%20size.pdf.
(SHRM, 2015)
Society for Human Resource Management
(SHRM). (2020a, May 6). Navigating
COVID–19: impact of the pandemic on
small businesses. https://shrm.org/hr-
today/trends-and-forecasting/research-
andsurveys/Documents/
SHRM%20CV19%20SBO%20Research%
20Presentation%20v1.1.pdf. (SHRM,
May 6, 2020a)
Society for Human Resource Management
(SHRM). (2020b, May 6). Survey:
COVID–19 could shutter most small
businesses. https://www.shrm.org/about-
shrm/press-room/press-releases/pages/
survey-covid-19-could-shutter-most-
small-businesses.aspx. (SHRM, May 6,
2020b)
United States (US) Census Bureau. (2021,
May). 2017 SUSB Annual Data Tables by
Establishment Industry, The annual data
table titled ‘‘U.S. & states, NAICS,
detailed employment sizes U.S., 6-digit
and states, NAICS sector,’’ https://
www.census.gov/data/tables/2017/econ/
susb/2017-susb-annual.html. (US Census
Bureau, May 2021)
C. Definitions
Paragraph (c) of the ETS provides
definitions of terms used in the section.
‘‘Assistant Secretary’’ means the
Assistant Secretary of Labor for
Occupational Safety and Health, U.S.
Department of Labor, or designee. This
definition provides clarification about
who can request and receive records
specified in paragraph (l)(3) of this
section. A designee includes a
representative conducting an inspection
or an investigation.
‘‘COVID–19 (Coronavirus Disease
2019)’’ means the disease caused by
SARS–CoV–2 (severe acute respiratory
syndrome coronavirus 2). SARS–CoV–2
is a highly transmissible virus that
spreads primarily through the
respiratory droplets that are produced
when an infected person coughs,
sneezes, sings, talks, or breathes. The
nature of the disease, variants of SARS–
CoV–2, disease transmission, and
associated health effects are all
described in great detail in Grave
Danger (Section III.A. of this preamble).
For clarity and ease of reference, the
ETS also uses the term ‘‘COVID–19’’
when describing exposures or potential
exposures to SARS–CoV–2. The
requirements of the ETS are intended to
address the grave danger of exposure to
COVID–19 in the workplace.
A ‘‘COVID–19 test’’ means a test for
SARS–CoV–2 that is: (1) Cleared,
approved, or authorized, including in an
Emergency Use Authorization (EUA), by
the U.S. Food and Drug Administration
(FDA) to detect current infection with
the SARS–CoV–2 virus (e.g., a viral
test); (2) administered in accordance
with the authorized instructions; and (3)
not both self-administered and self-read
unless observed by the employer or an
authorized telehealth proctor. Examples
of tests that satisfy this requirement
include tests with specimens that are
processed by a laboratory (including
home or on-site collected specimens
which are processed either individually
or as pooled specimens), proctored over-
the-counter tests, point of care tests, and
tests where specimen collection and
processing is either done or observed by
an employer.
Under paragraph (g), employees who
are not fully vaccinated must be tested
for COVID–19. When an employee must
be tested, the test is considered
acceptable only if the test and the
administration of the test satisfy the
definition of COVID–19 test in this
standard.
COVID–19 tests can broadly be
divided into two categories, diagnostic
tests and antibody tests. Diagnostic tests
detect parts of the SARS–CoV–2 virus
and can be used to diagnose current
infection. On the other hand, antibody
tests look for antibodies in the immune
system produced in response to SARS–
CoV–2, and are not used to diagnose an
active COVID–19 infection. Antibody
tests do not meet the definition of
COVID–19 test for the purposes of this
ETS.
Diagnostic tests for current infection
fall into two categories: Nucleic acid
amplification tests (NAATs) and antigen
tests. NAATs are a type of molecular
test that detect genetic material (nucleic
acids); NAATs for COVID–19 identify
the ribonucleic acid (RNA) sequences
that comprise the genetic material of the
virus. NAATs can reliably detect small
amounts of SARS–CoV–2 and are
unlikely to return a false-negative result.
NAATs use many different methods to
detect the virus, including reverse
transcription-polymerase chain reaction
(RT–PCR), which is a high-sensitivity,
high-specificity 90 test for diagnosing
SARS–CoV–2 infection. Other types of
NAATs that use isothermal
amplification methods include nicking
endonuclease amplification reaction
(NEAR), transcription mediated
amplification (TMA), loop-mediated
isothermal amplification (LAMP),
helicase-dependent amplification
(HDA), clustered regularly interspaced
short palindromic repeats (CRISPR), and
strand displacement amplification
(SDA) (CDC, June 14, 2021).
Most NAATs need to be processed in
a laboratory with variable time to
receive results (approximately 1–2
days), but some NAATs are point-of-
care tests with results available in about
15–45 minutes. As of October 14, 2021,
264 molecular tests (NAATs) and
collection devices have EUA from the
FDA for COVID–19 (FDA, October 14,
2021b). These tests may be acceptable
under the ETS.
Antigen tests may also meet the
definition of COVID–19 test under this
standard. Antigen tests indicate current
infection by detecting the presence of a
specific viral antigen. Most can be
processed at the point of care with
results available in about 1530 minutes.
Antigen tests generally have similar
specificity to, but are less sensitive than,
NAATs (CDC, October 7, 2021). As of
October 14, 2021, thirty-seven antigen
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tests have EUA from the FDA for
COVID–19 (FDA, October 14, 2021a).
These tests may be acceptable under the
ETS.
Most antigen tests and some NAATs
are conducted at the point of care,
which means the test processing and
result reading is performed at or near
the place where a specimen is collected
so that results can be obtained within
minutes rather than hours or days.
Rapid point-of-care tests are
administered in various settings
operating under a Clinical Laboratory
Improvement Amendments of 1988
(CLIA) certificate of waiver, such as
physician offices, urgent care facilities,
pharmacies, school health clinics,
workplace health clinics, long-term care
facilities and nursing homes, and at
temporary locations, such as drive-
through sites managed by local health
organizations (FDA, November 16,
2020).
To be a valid COVID–19 test under
this standard, a test may not be both
self-administered and self-read unless
observed by the employer or an
authorized telehealth proctor. OSHA
included the requirement for some type
of independent confirmation of the test
result in order to ensure the integrity of
the result given the ‘‘many social and
financial pressures for test-takers to
misrepresent their results’’ (Schulte et
al., May 19, 2021). This independent
confirmation can be accomplished in
multiple ways, including through the
involvement of a licensed healthcare
provider or a point-of-care test provider.
If an over-the-counter (OTC) test is
being used, it must be used in
accordance with the authorized
instructions. The employer can validate
the test through the use of a proctored
test that is supervised by an authorized
telehealth provider. Alternatively, the
employer could proctor the OTC test
itself.
Employers have the flexibility to
select the testing scenario that is most
appropriate for their workplace. Some
employees and employers may rely on
testing that is conducted by a healthcare
provider (e.g., doctor or nurse) who
arranges for the specimen to be analyzed
at a laboratory or at a point-of-care
testing location (e.g., a pharmacy). The
involvement of licensed or accredited
healthcare providers allows employers
to have a high degree of confidence in
the suitability of the test and the test
results. Some large employers who set
up their own on-site testing program
may partner with a healthcare
organization (e.g., a local hospital or
clinic) or rely on a licensed healthcare
provider to help obtain a CLIA
certificate of waiver. Other employers
may simply require that employees
perform and read their own OTC test
while an authorized employee observes
the administration and reading of the
test to ensure that a new test kit was
used and that the test was administered
properly (e.g., nostrils were swabbed),
and to witness the test result.
Due to the potential for employee
misconduct (e.g., falsified results), tests
that are both self-administered and self-
read are not acceptable unless they are
observed by the employer or an
authorized telehealth proctor. Some
COVID–19 tests are authorized by the
FDA to be performed only with the
supervision of a telehealth proctor,
which is someone who is trained to
observe sample collection and provide
instructions and result interpretation
assistance to individuals using the test.
The term ‘‘authorized telehealth
proctor’’ refers to proctors who follow
the requirements for proctoring
specified by the FDA authorization. For
a more detailed discussion on COVID–
19 testing requirements under this ETS,
see the Summary and Explanation for
paragraph (g) (Section VI.G. of this
preamble).
A ‘‘face covering’’ means a covering
that: (1) Completely covers the nose and
mouth; (2) is made with two or more
layers of a breathable fabric that is
tightly woven (i.e., fabrics that do not let
light pass through when held up to a
light source); (3) is secured to the head
with ties, ear loops, or elastic bands that
go behind the head. If gaiters are worn,
they should have two layers of fabric or
be folded to make two layers; (4) fits
snugly over the nose, mouth, and chin
with no large gaps on the outside of the
face; and (5) is a solid piece of material
without slits, exhalation valves, visible
holes, punctures, or other openings.
This definition includes clear face
coverings or cloth face coverings with a
clear plastic panel that, despite the non-
cloth material allowing light to pass
through, otherwise meet this definition
and which may be used to facilitate
communication with people who are
deaf or hard-of-hearing or others who
need to see a speaker’s mouth or facial
expressions to understand speech or
sign language respectively. Face
coverings can be manufactured or
homemade, and they can incorporate a
variety of designs, structures, and
materials. Face coverings provide
variable levels of protection based on
their design and construction.
As explained in paragraph (i), face
covering use is required based on an
employee’s vaccination status. The
criteria in the definition help to ensure
that face coverings that are worn by
workers who are not fully vaccinated
will provide effective source control and
some degree of personal protection.
Source control means reducing the
spread of large respiratory droplets to
others by covering a person’s mouth and
nose. The personal protection afforded
by face coverings, as well as the benefits
and necessity, are described in the
Summary and Explanation for
paragraph (i) (Section VI.I. of this
preamble).
Face coverings differ from facemasks
and respirators, which are also defined
in paragraph (c) of this section. Face
coverings, unlike facemasks and
respirators, are not considered to be
personal protective equipment (PPE)
under OSHA’s general PPE standard (29
CFR 1910.132), as discussed in the
Summary and Explanation for
paragraph (i) (Section VI.I. of this
preamble).
Lastly, face coverings as required by
this standard do not have to meet a
consensus standard, although face
coverings that adhere to such consensus
standards, with design and construction
specifications, meet the definition and
may offer both greater protection and
the confidence that at least a minimum
level of protection has been provided.
The National Institute for Occupational
Safety and Health (NIOSH) recommends
that employers and workers who want
a face covering that provides a known
level of protection use face coverings
that meet a new standard, called
Workplace Performance and Workplace
Performance Plus masks, for
workplaces. As discussed in the
Summary and Explanation for
paragraph (i) (Section VI.I. of this
preamble), the new NIOSH criteria and
the ASTM Specification for Barrier Face
Coverings, F3502–21 (ASTM Standard)
provide a greater level of source control
performance for workers when wearing
the face covering according to
manufacturer’s instructions. The NIOSH
criteria require that face coverings
conform to the ASTM Standard and
meet additional quantitative leakage
criteria. Although not required by the
standard, OSHA notes that face
coverings that meet ASTM F3502–21
requirements and the new NIOSH
criteria may offer a higher level of
source control and wearer protection
than those face coverings that do not
meet a consensus standard.
A ‘‘facemask’’ means a surgical,
medical procedure, dental, or isolation
mask that is FDA-cleared, authorized by
an FDA EUA, or offered or distributed
as described in an FDA enforcement
policy. Facemasks may also be referred
to as ‘‘medical procedure masks.’’ This
definition provides clarification about
the exception to the face covering
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91 As defined by CDC’s informational document,
Summary Document for Interim Clinical
Considerations for Use of COVID–19 Vaccines
Currently Authorized in the United States (CDC,
September 29, 2021).
requirement under paragraph (i)(1)(iii)
that permits facemask use in lieu of face
coverings. OSHA notes that facemasks
are not respirators, which are also
defined in this section.
Facemasks provide protection against
exposure to splashes, sprays, and spatter
of body fluids. Facemasks offer both
source control, as defined in this section
under face coverings, and protection for
the wearer. OSHA has previously
established that facemasks are essential
PPE for employees in healthcare, under
both the general PPE standard (29 CFR
part 1910.132) and the Bloodborne
Pathogens standard (29 CFR part
1910.1030). Although not required, the
Summary and Explanation for
paragraph (i) (Section VI.I. of this
preamble) addresses their inclusion in
this standard. Additional information
on such facemasks can be found in
relevant FDA guidance.
‘‘Fully vaccinated’’ means (i) a
person’s status 2 weeks after completing
primary vaccination with a COVID–19
vaccine with, if applicable, at least the
minimum recommended interval
between doses in accordance with the
approval, authorization, or listing that
is: (A) Approved or authorized for
emergency use by the FDA; (B) listed for
emergency use by the World Health
Organization (WHO); or (C)
administered as part of a clinical trial at
U.S. site, if the recipient is documented
to have of primary vaccination with the
‘‘active’’ (not placebo) COVID–19
vaccine candidate, for which vaccine
efficacy has been independently
confirmed (e.g., by a data and safety
monitoring board) or if the clinical trial
participant from the U.S. sites had
received a COVID–19 vaccine that is
neither approved nor authorized for use
by the FDA but is listed for emergency
use by the WHO. Currently-authorized
FDA vaccines include Janssen (Johnson
& Johnson), which is a single-dose
primary vaccination, and Pfizer-
BioNTech and Moderna, which have a
two-dose primary vaccination series.
This definition is consistent with the
CDC definition of fully vaccinated (CDC,
September 16, 2021).
The definition of ‘‘fully vaccinated’’
also means a person’s status 2 weeks
after receiving the second dose of any
combination of two doses of a COVID–
19 vaccine that is approved or
authorized by the FDA, or listed as a
two-dose series by the WHO (i.e.,
heterologous primary series of such
vaccines, receiving doses of different
COVID–19 vaccines as part of one
primary series). The second dose of the
series must not be received earlier than
17 days (21 days with a 4-day grace
period) after the first dose (CDC,
October 15, 2021). OSHA has included
this because people who have received
a heterologous primary vaccination
series (including mixing of mRNA,
adenoviral, and mRNA plus adenoviral
products) are considered by the CDC to
also meet this definition. OSHA
considers a vaccination series that meets
the definition in subparagraph (ii) to be
a primary vaccination for purposes of
the requirements to support vaccination
in paragraph (f).
The employer obligations under the
ETS differ based on whether each
employee is fully vaccinated. This
definition is relevant to the definition of
mandatory vaccination policy, in this
paragraph (c), as well as the provisions
under paragraph (d) regarding written
vaccination policy requirements and
relevant procedures for workers who are
fully vaccinated. Paragraph (e)(2) also
addresses fully vaccinated employees,
including the determination of
vaccination status and acceptable forms
of proof. Lastly, the definition provides
clarity with regard to the requirements
of paragraphs (g) and (i) respectively,
which contain requirements for regular
COVID–19 testing and face covering use
among employees who are not fully
vaccinated.
Paragraph (e) requires employers to
determine each employee’s vaccination
status, including whether they are fully
or partially vaccinated. By ‘‘partially
vaccinated,’’ OSHA means someone
who has started a primary vaccination
series but not completed it (e.g., has
received one dose of a two-dose series)
or has completed their primary
vaccination and two weeks have not
elapsed since the last dose of the
primary vaccination.
A ‘‘mandatory vaccination policy’’ is
an employer policy requiring each
employee to be fully vaccinated. To
meet the definition of a mandatory
vaccination policy, the policy must
require: Vaccination of all employees,
including vaccination of all new
employees as soon as practicable, other
than those employees (1) for whom a
vaccine is medically contraindicated, (2)
for whom medical necessity requires a
delay in vaccination,91 or (3) who are
legally entitled to a reasonable
accommodation under federal civil
rights laws because they have a
disability or sincerely held religious
beliefs, practices, or observances that
conflict with the vaccination
requirement. OSHA intends that
‘‘employee,’’ as used in this definition,
includes only employees that are
covered by this ETS and does not
include employees who are excluded
from coverage under paragraph (b)(3).
Paragraph (d)(1) of the standard
requires an employer to establish,
implement, and enforce a written
mandatory vaccination policy that
meets this definition. The benefits of
vaccination, including the effectiveness
of vaccination mandates, are discussed
in Grave Danger (Section III.A. of this
preamble) and Need for the ETS
(Section III.B. of this preamble).
OSHA recognizes that vaccination
policies may vary, as indicated in
paragraph (d)(2). Any policy that
permits the employee to choose between
vaccination and COVID–19 testing and
face covering use would not be
considered a mandatory vaccination
policy under paragraph (d)(1), although
such policy is permissible under
paragraph (d)(2). In some cases,
employers may implement vaccination
policies that differ by location or type of
business operation and thus the
application of paragraph (d)(2) might
vary across an employer’s workforce.
This is discussed in greater detail in the
Summary and Explanation for
paragraph (d) (Section VI.D. of this
preamble).
A ‘‘respirator’’ is a type of PPE that is
certified by NIOSH under 42 CFR part
84 or is authorized under an EUA by the
FDA. These specifications are intended
to ensure some consistent level of
testing, approval, and protection and to
prevent the use of counterfeit respirators
that will not offer adequate protection,
which is important because respirators
are intended to protect the wearer when
directly exposed to hazards. Respirators
protect against airborne hazards by
removing specific air contaminants from
the ambient (surrounding) air or by
supplying breathable air from a safe
source. Common types of respirators
include filtering facepiece respirators
(e.g., N95), elastomeric respirators, and
powered air-purifying respirators
(PAPRs). Face coverings, facemasks, and
face shields are not respirators.
As stated above, there are various
types of respirators that would fall
within this definition. A filtering
facepiece respirator (FFR) is a negative-
pressure particulate respirator with a
non-replaceable filter as an integral part
of the facepiece or with the entire
facepiece composed of the non-
replaceable filtering medium. N95 FFRs
are the most common type of FFR and
are the type of respirator most often
used to control exposures to infections
transmitted via the airborne route.
When properly worn, N95 FFRs filter at
least 95% of airborne particles. An
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elastomeric respirator is a tight-fitting
respirator with a facepiece that is made
of synthetic or rubber material that
permits it to be disinfected, cleaned,
and reused according to the
manufacturer’s instructions. Elastomeric
respirators are equipped with
replaceable cartridges, canisters, or
filters. Lastly, a powered air-purifying
respirator (PAPR) is an air-purifying
respirator that uses a blower to force the
ambient air through air-purifying
elements to the inlet covering.
This standard does not require the use
of respirators. This definition is
included because it relates to paragraph
(i)(1)(iii), which exempts employees
from wearing face coverings when they
are wearing respirators or facemasks. In
addition, paragraph (i)(4) requires
employers to permit employees to wear
a respirator instead of a face covering
and permits employers to provide
respirators to their employees, instead
of face coverings. When respirators are
used pursuant to paragraph (i)(4), the
employer must also comply with
§ 1910.504, the Mini Respiratory
Protection Program.
NIOSH has developed a set of
regulations in 42 CFR part 84 for testing
and certifying non-powered, air-
purifying, particulate-filter respirators.
To help address concerns about
availability during the COVID–19
pandemic, the FDA has issued EUAs for
certain PPE products, including
respiratory protective devices such as
respirators. For the purposes of this
standard, respirators certified by
NIOSH, under 42 CFR part 84 or
authorized under an EUA by the FDA
meet the definition. Additional
information on such respirators can be
found in relevant FDA and NIOSH
guidance.
A ‘‘workplace’’ is a physical location
(e.g., fixed, mobile) where the
employer’s work or operations are
performed. It does not include an
employee’s residence, even if the
employee is teleworking from their
residence. Examples of fixed locations
include: Offices, retail establishments,
co-working facilities, and factories or
manufacturing facilities. A workplace
includes the entire site (including
outdoor and indoor areas, a structure or
a group of structures) or an area within
a site where work or any work-related
activity occurs (e.g., taking breaks, going
to the restroom, eating, entering or
exiting work). The workplace includes
the entirety of any space associated with
the site (e.g., workstations, hallways,
stairwells, breakrooms, bathrooms,
elevators) and any other space that an
employee might occupy in arriving,
working, or leaving. Examples of
employees who have mobile workplaces
include maintenance and repair
technicians who go to homes or
businesses to provide repair services, or
those who provide delivery services.
References
Centers for Disease Control and Prevention
(CDC). (2021, June 14). Nucleic Acid
Amplification Tests. https://
www.cdc.gov/coronavirus/2019-ncov/
lab/naats.html. (CDC, June 14, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, September 16). When
You’ve Been Fully Vaccinated: How to
Protect Yourself and Others. https://
www.cdc.gov/coronavirus/2019-ncov/
vaccines/fully-vaccinated.html. (CDC,
September 16, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, September 29). Summary
Document for Interim Clinical
Considerations for Use of COVID–19
Vaccines Currently Authorized in the
United States. https://www.cdc.gov/
vaccines/covid-19/downloads/summary-
interim-clinical-considerations.pdf.
(CDC, September 29, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, October 7). Interim
Guidance for SARS–CoV–2 Testing in
Non-Healthcare Workplaces. https://
www.cdc.gov/coronavirus/2019-ncov/
community/organizations/testing-non-
healthcare-workplaces.html. (CDC,
October 7, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, October 15). Interim Public
Health Recommendations for Fully
Vaccinated People. https://www.cdc.gov/
coronavirus/2019-ncov/vaccines/fully-
vaccinated-guidance.html. (CDC,
October 15, 2021)
Equal Employment Opportunity Commission
(EEOC). (2021, October 25). What You
Should Know About COVID–19 and the
ADA, the Rehabilitation Act, and Other
EEO Laws. https://www.eeoc.gov/wysk/
what-you-should-know-about-covid-19-
and-ada-rehabilitation-act-and-other-
eeo-laws. (EEOC, October 25, 2021)
Food and Drug Administration (FDA). (2020,
November 16). COVID–19 Test Settings:
FAQs on Testing for SARS–CoV–2.
https://www.fda.gov/medical-devices/
coronavirus-covid-19-and-medical-
devices/covid-19-test-settings-faqs-
testing-sars-cov-2. (FDA, November 16,
2020)
Food and Drug Administration (FDA).
(2021a, October 14). In Vitro Diagnostics
EUAs—Antigen Diagnostic Tests for
SARS–CoV–2. https://www.fda.gov/
medical-devices/coronavirus-disease-
2019-covid-19-emergency-use-
authorizations-medical-devices/in-vitro-
diagnostics-euas-antigen-diagnostic-
tests-sars-cov-2. (FDA, October 14,
2021a)
Food and Drug Administration (FDA).
(2021b, October 14)). In Vitro Diagnostics
EUAs—Molecular Diagnostic Tests for
SARS–CoV–2. https://www.fda.gov/
medical-devices/coronavirus-disease-
2019-covid-19-emergency-use-
authorizations-medical-devices/in-vitro-
diagnostics-euas-molecular-diagnostic-
tests-sars-cov-2. (FDA, October 14,
2021b)
Schulte P et al. (2021, May 19). Proposed
Framework for Considering SARS–CoV–
2 Antigen Testing of Unexposed
Asymptomatic Workers in Selected
Workplaces. J Occup Environ Med. 2021
Aug; 63(8): 646–656. Published online
2021, May 19. https://
www.ncbi.nlm.nih.gov/pmc/articles/
PMC8327768/. (Schulte et al., May 19,
2021)
D. Employer Policy on Vaccination
Vaccination is a vital tool to reduce
the presence and severity of COVID–19
cases in the workplace, in communities,
and in the nation as a whole. Despite
the robust protection against COVID–19
that vaccination affords, millions of
eligible individuals have not yet been
vaccinated. Current efforts to increase
the proportion of the U.S. population
that is fully vaccinated against COVID–
19 are critical to ending the COVID–19
pandemic (CDC, September 15, 2021).
As described more fully in Need for the
ETS (Section III.B. of this preamble),
mandatory vaccination policies work.
Therefore, OSHA has determined that
requiring or strongly encouraging
vaccination—the most effective and
efficient control for reducing COVID–
19—is key to ensuring the protection of
workers against the grave danger of
exposure to SARS–CoV–2 in the
workplace (see Grave Danger, Section
III.A. of this preamble). Therefore, this
ETS requires employers to adopt
mandatory vaccination policies for their
workplaces, with an exception for
employers that instead adopt a policy
allowing employees to elect to undergo
regular COVID–19 testing and wear a
face covering at work in lieu of
vaccination. In Need for the ETS
(Section III.B of this preamble), OSHA
explains its rationale for providing the
exception.
Paragraph (d) of this ETS is a critical
element in ensuring employees’
protection, as it requires covered
employers to develop, implement, and
enforce written policies on COVID–19
vaccination for their workforces.
Paragraph (d)(1) requires the employer
to establish, implement, and enforce a
written mandatory vaccination policy.
As defined in paragraph (c), a
mandatory vaccination policy is an
employer policy requiring each
employee to be fully vaccinated. Such a
policy must require vaccination of all
employees, other than those employees
who fall into one of three categories: (1)
Those for whom a vaccine is medically
contraindicated, (2) those for whom
medical necessity requires a delay in
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vaccination, or (3) those who are legally
entitled to a reasonable accommodation
under federal civil rights laws because
they have a disability or sincerely held
religious beliefs, practices, or
observances that conflict with the
vaccination requirement. The policy
must also require all new employees to
be vaccinated as soon as practicable.
Paragraph (d)(2) is a limited
exemption from the mandatory
vaccination policy requirement. As
discussed in Need for the ETS (Section
III.B. of this preamble), vaccination
mandates are effective at increasing
overall vaccination rates and protecting
employees and, therefore, the agency
encourages all employers to implement
a mandatory vaccination policy. Under
paragraph (d)(2), however, employers
can avoid the mandate in paragraph
(d)(1) if the employer establishes,
implements, and enforces a written
policy allowing any employee not
subject to a mandatory vaccination
policy to choose either to: (1) Be fully
vaccinated against COVID–19 or (2)
provide proof of regular testing for
COVID–19 in accordance with
paragraph (g) of this section and wear a
face covering in accordance with
paragraph (i). An employer who chooses
to operate under paragraph (d)(2),
however, must still offer the support for
vaccination required under paragraph (f)
and may not prevent employees from
getting vaccinated. Adopting a policy
under paragraph (d)(2) simply means
that employees themselves may choose
not to get vaccinated, in which case they
must get tested and wear face coverings
per the requirements of the standard.
OSHA recognizes there may be
employers who develop and implement
partial mandatory vaccination policies,
i.e., that apply to only a portion of their
workforce. An example might be a retail
corporation employer who has a
mixture of staff working at the corporate
headquarters, performing intermittent
telework from home, and working in
stores serving customers. In this type of
situation, the employer may choose to
require vaccination of only some subset
of its employees (e.g., those working in
stores), and to treat vaccination as
optional for others (e.g., those who work
from headquarters or who perform
intermittent telework). This approach
would comply with the standard so long
as the employer complies in full with
paragraph (d)(1) and (d)(2) for the
respective groups.
OSHA uses the terms establish,
implement, and enforce in paragraph (d)
to emphasize that it is necessary for an
employer to first determine its policy
and create a written record of that
policy. After determining the policy, an
employer must then ensure that it is
following the policy, as laid out in its
written plan. Finally, employers must
ensure that they enforce the
requirements of their policies with
respect to their workforce, through
training and the use of such
mechanisms as work rules and the
workplace disciplinary system, if
necessary. These requirements apply to
the written policy required under
paragraph (d), whether employers
choose to implement the mandatory
vaccination policy under paragraph
(d)(1) or utilize the exemption under
paragraph (d)(2) for all or a portion of
their workforce.
To ensure that employers’ vaccination
policies under paragraph (d) are
comprehensive and effective, the
policies should address all of the
applicable requirements in paragraphs
(e)–(j) of this standard, including:
Requirements for COVID–19
vaccination; applicable exclusions from
the written policy (e.g., medical
contraindications, medical necessity
requiring delay in vaccination, or
reasonable accommodations for workers
with disabilities or sincerely held
religious beliefs); information on
determining an employee’s vaccination
status and how this information will be
collected (as described in paragraph (e));
paid time and sick leave for vaccination
purposes (as described in paragraph (f));
notification of positive COVID–19 tests
and removal of COVID–19 positive
employees from the workplace (as
described in paragraph (h)); information
to be provided to employees (pursuant
to paragraph (j)—e.g., how the employer
is making that information available to
employees); and disciplinary action for
employees who do not abide by the
policy. In addition to addressing the
requirements of paragraphs (e)–(j) of this
standard, the employer should include
all relevant information regarding the
policy’s effective date, who the policy
applies to, deadlines (e.g., for
submitting vaccination information, for
getting vaccinated), and procedures for
compliance and enforcement, all of
which are necessary components of an
effective plan. Having a comprehensive
written policy will provide a solid
foundation for an effective COVID–19
vaccination program, while making it
easier for employers to inform
employees about the program-related
policies and procedures, as required
under paragraph (j)(1).
If an employer utilizes the exemption
under paragraph (d)(2), its workplace
may contain employees who are
vaccinated and unvaccinated. This
might be the case even for employers
who establish a mandatory vaccination
policy under paragraph (d)(1); for
example, an employer with a mandatory
vaccination policy might have
employees who cannot be vaccinated for
medical reasons. Given the additional
safety protocols under this standard for
individuals who are not fully vaccinated
(see paragraphs (g) and (i)), an employer
who has both vaccinated and
unvaccinated employees will have to
develop and include the relevant
procedures for two sets of employees in
the written policy. The procedures for
those who are fully vaccinated should
contain all the information previously
discussed relevant to establishing,
implementing, and enforcing a
comprehensive written policy.
However, the procedures applicable to
employees who are not fully vaccinated
(i.e., those who decline vaccination,
those who are unable to receive
vaccination and are, absent undue
hardship to their employers, entitled to
reasonable accommodation) and those
who are unable to provide proof of
vaccination as required by paragraph (e)
(who must be treated as not fully
vaccinated), must include COVID–19
testing and face covering use as required
by paragraphs (g) and (i), respectively,
unless the reasonable accommodation
from vaccination removes the employee
from the scope of § 1910.501 (e.g., full
time telework consistent with one of the
exceptions in § 1910.501(b)(3)). OSHA
intends that such an employer will
develop one written plan that includes
different policies and procedures for
vaccinated and unvaccinated
employees. The requirements of
paragraphs (e), (f), (h), and (j) should be
addressed in the policy regardless of the
vaccination requirements adopted by
the employer.
As with all elements of the written
plan, an effective written plan will
explain the testing requirements
contained in paragraph (g) for
unvaccinated employees, and how the
employer will implement and enforce
those policies. As described in
paragraph (g)(1), the testing
requirements differ for employees who
report at least once every 7 days to a
workplace compared to those who do
not. Thus, the policy may describe
different testing procedures for those
different groups of employees,
depending on how often they physically
report to a workplace where other
individuals are present. As described in
paragraph (g)(3), the testing
requirements are temporarily suspended
for 90 days following a positive COVID–
19 test or diagnosis. Thus, the
employer’s policy and procedures to
implement this temporary suspension of
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testing should be included in their
written workplace policy. In addition to
the testing requirements in paragraph
(g), an effective policy must address
mandatory face covering use as
described in paragraph (i), including
procedures for employee compliance.
Employers can get more information on
the requirements for paragraphs (e)
through (j), and what they must do to
comply with those provisions of the
standard, in the relevant Summary and
Explanation sections (see Section VI. of
this preamble).
As an employer develops their written
policy, they must address how the
policy will apply to new employees.
Although many new hires will be fully
vaccinated, there should be procedures
within the plan to collect information
about the new employee’s vaccination
status, and determine when an
unvaccinated new hire must be
vaccinated and, for employers using a
plan under paragraph (d)(2), when
COVID–19 testing and face covering use
will commence if an employee remains
unvaccinated. All new hires should be
treated similarly to any employee who
has not entered the workplace in the last
seven days and will need to be fully
vaccinated or provide proof of a
negative COVID–19 test within the last
seven days prior to entering the
workplace for the first time. It is not
OSHA’s intention to discourage
employers from hiring new employees,
but rather to ensure that new employees
are as well-protected from COVID–19
hazards in the workplace as current
employees and are less likely to spread
the virus to other employees.
An employer may have already
developed and implemented a written
policy on vaccination, testing, and/or
face covering use to protect employees
from COVID–19. It is not OSHA’s intent
for employers to duplicate current
effective policies covering the
requirements of this ETS; however, each
employer with a current policy must
evaluate that policy to ensure it satisfies
all of the requirements of this rule.
Employers with existing policies must
modify and/or update their current
policies to incorporate any missing
required elements, and must provide
information on these new updates or
modifications to all employees in
accordance with paragraph (j)(1). Once
the employer has developed its policy
pursuant to paragraph (d), the policy
must be reduced to writing in order to
be compliant with paragraph (d).
The note to paragraph (d) was
included in recognition that, under
federal law, some employees may be
entitled to a reasonable accommodation
from their employer, absent undue
hardship. If the worker requesting a
reasonable accommodation cannot be
vaccinated and/or wear a face covering
because of a disability, as defined by the
Americans with Disabilities Act (ADA),
that worker may be entitled to a
reasonable accommodation. In addition,
if the vaccination, and/or testing for
COVID–19, and/or wearing a face
covering conflicts with a sincerely held
religious belief, practice or observance,
a worker may be entitled to a reasonable
accommodation. Such accommodations
exist independently of the Occupational
Safety and Health Act and, therefore,
OSHA does not administer or enforce
these laws. Examples of relevant federal
laws under which an accommodation
can be requested include the Americans
with Disabilities Act (ADA) and Title
VII of the Civil Rights Act of 1964.
For more information, the note refers
to a resource produced by the Equal
Employment Opportunity Commission
(EEOC), which is responsible for
enforcing federal laws that prohibit
employment-related discrimination
based on a person’s race, color, religion,
sex (including pregnancy, gender
identity, and sexual orientation),
national origin, age (40 or older),
disability, or genetic information. The
EEOC resource listed in the note, What
You Should Know About COVID–19
and the ADA, the Rehabilitation Act,
and Other EEO Laws, available at
https://www.eeoc.gov/wysk/what-you-
should-know-about-covid-19-and-ada-
rehabilitation-act-and-other-eeo-laws,
should be helpful to employers in
navigating employees’ requests for
accommodations, including the process
for determining a reasonable
accommodation and information on
undue hardship (EEOC, October 25,
2021). An additional resource that might
be helpful is the CDC’s informational
document, Summary Document for
Interim Clinical Considerations for Use
of COVID–19 Vaccines Currently
Authorized in the United States (CDC,
September 29, 2021), which lists the
recognized clinical contraindications to
receiving a COVID–19 vaccine.
References
Centers for Disease Control and Prevention
(CDC). (2021, September 15). Science
Brief: Background rationale and evidence
for public health recommendations for
fully vaccinated people. https://
www.cdc.gov/coronavirus/2019-ncov/
science/science-briefs/fully-vaccinated-
people.html. (CDC, September 15, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, September 29). Summary
Document for Interim Clinical
Considerations for Use of COVID–19
Vaccines Currently Authorized in the
United States. https://www.cdc.gov/
vaccines/covid-19/downloads/summary-
interim-clinical-considerations.pdf.
(CDC, September 29, 2021)
Equal Employment Opportunity Commission
(EEOC). (2021, October 25). What You
Should Know About COVID–19 and the
ADA, the Rehabilitation Act, and Other
EEO Laws. https://www.eeoc.gov/wysk/
what-you-should-know-about-covid-19-
and-ada-rehabilitation-act-and-other-
eeo-laws. (EEOC, October 25, 2021)
E. Determination of Employee
Vaccination Status
To comply with the requirements of
the standard, it is essential that
employers are aware of each employee’s
vaccination status. As discussed in the
Summary and Explanation for
paragraph (d) (Section VI.D. of this
preamble), effective implementation and
enforcement of a written vaccination
policy requires the employer to know
the vaccination status of all employees.
Furthermore, the employer must know
each employee’s vaccination status in
order to ensure that the vaccination,
testing, and face covering requirements
of the standard are met. As such,
paragraph (e) includes provisions for
determining each employee’s
vaccination status. The standard
requires employers to determine the
vaccination status of each employee
(paragraph (e)(1)), and also to maintain
records of each employee’s vaccination
status, preserve acceptable proof of
vaccination for each employee who is
fully or partially vaccinated, and
maintain a roster of each employee’s
vaccination status (paragraph (e)(4)). As
discussed more fully below,
maintenance of records in accordance
with this paragraph is subject to
applicable legal requirements for
confidentiality of medical information.
Additional provisions in paragraph (e)
define acceptable proof of vaccination
status for vaccinated employees
(paragraph (e)(2)) and provide that any
employee who does not submit an
acceptable form of proof of vaccination
status must be treated as not fully
vaccinated (paragraph (e)(3)).
Paragraph (e)(1) requires the employer
to determine the vaccination status of
each employee, including whether the
employee is fully vaccinated. Under
paragraph (e)(2), the employer must
require each vaccinated employee to
provide acceptable proof of vaccination
status, including whether they are fully
or partially vaccinated. This is an
ongoing requirement for the employer
(i.e., the employer needs to update this
information as employees proceed
through the vaccination process).
Paragraph (e)(2) defines what
‘‘acceptable proof of vaccination status’’
means for purposes of the ETS, and
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employers must accept any of the proofs
listed in accordance with the terms of
the standard and as explained more
fully below. Under paragraph (e)(2), the
following are acceptable for proof of
vaccination: (i) The record of
immunization from a health care
provider or pharmacy; (ii) a copy of the
U.S. CDC COVID–19 Vaccination
Record Card (CDC Form MLS–319813_
r, published on September 3, 2020)
(CDC, October 5, 2021); (iii) a copy of
medical records documenting the
vaccination; (iv) a copy of immunization
records from a public health, state, or
tribal immunization information system;
or (v) a copy of any other official
documentation that contains the type of
vaccine administered, date(s) of
administration, and the name of the
health care professional(s) or clinic
site(s) administering the vaccine(s).
To be acceptable as proof of
vaccination, any documentation should
generally include the employee’s name,
type of vaccine administered, date(s) of
administration, and the name of the
health care professional(s) or clinic
site(s) administering the vaccine(s). In
some cases, state immunization records
may not include one or more of these
data fields, such as clinic site; in those
circumstances, an employer can still
rely upon the State immunization
record as acceptable proof of
vaccination. OSHA notes that clinic
sites can include temporary vaccination
facilities used during large vaccine
distribution campaigns, such as schools,
churches, or sports stadiums. Copies,
including digital copies, of the listed
forms of proof are acceptable means of
documentation so long as they clearly
and legibly display the necessary
information. Digital copies can include,
for example, a digital photograph,
scanned image, or PDF of an acceptable
form of proof. Some state governments
are utilizing digital COVID–19 vaccine
records showing the same information
as the U.S. CDC COVID–19 Vaccination
Record Card (CDC Form MLS–319813_
r, published on September 3, 2020) and
providing quick response (QR) codes
that when scanned will provide the
same information (see, e.g., New York
State Government, n.d., Retrieved
October 4, 2021). In certain states, the
QR code confirms the vaccine record as
an official record of the state (see, e.g.,
State of California, n.d., Retrieved
October 7, 2021) and therefore would
provide acceptable proof of vaccination
under the ETS (see paragraph (e)(2)(iv)).
However, as discussed later, the
employer must retain a copy of the
vaccination information retrieved when
the QR code is scanned, not just the QR
code itself, to comply with paragraph
(e)(4). In requesting proof of
vaccination, the employer must take
care to comply with any applicable
Federal laws, including requirements
under the Privacy Act, 5 U.S.C. 552a,
and the Americans with Disabilities Act
(ADA), 42 U.S.C. 12101 et seq.
Each employee who has been partially
or fully vaccinated should be able to
provide one of the forms of acceptable
proof listed above (paragraphs (e)(2)(i)–
(e)(2)(v)). An employee who does not
possess their COVID–19 vaccination
record (e.g., because it was lost or
stolen) should contact their vaccination
provider (e.g., local pharmacy,
physician’s office) to obtain a new copy
or utilize their state health department’s
immunization information system. In
instances where an employee is unable
to produce acceptable proof of
vaccination under paragraphs (e)(2)(i)–
(e)(2)(v), paragraph (e)(2)(vi) provides
that a signed and dated statement by the
employee will be acceptable. The
employee’s statement must: (A) Attest to
their vaccination status (fully
vaccinated or partially vaccinated); (B)
attest that they have lost or are
otherwise unable to produce proof
required by the standard; and (C)
include the following language: ‘‘I
declare (or certify, verify, or state) that
this statement about my vaccination
status is true and accurate. I understand
that knowingly providing false
information regarding my vaccination
status on this form may subject me to
criminal penalties.’’ The note to
paragraph (e)(2)(vi) explains that an
employee who attests to their
vaccination status should, to the best of
their recollection, include the following
information in their attestation: The
type of vaccine administered; date(s) of
administration; and the name of the
health care professional(s) or clinic
site(s) administering the vaccine(s). For
example, some of the information may
be easier to recall, such as receiving a
vaccine at a mass vaccination site or
local pharmacy, while the dates of
administration might only be
remembered as falling within a
particular month or months. OSHA
understands that employees may not be
able to recall certain information, such
as the type of vaccine received.
Employees providing attestations
should include as much of this
information as they can remember to the
best of their ability.
Any statement provided under
paragraph (e)(2)(vi) must include an
attestation that the employee is unable
to produce another type of proof of
vaccination (paragraph (e)(2)(vi)(B)).
Thus, before an employee statement will
be acceptable for proof of vaccination
under paragraph (e)(2)(vi), the employee
must have attempted to secure alternate
forms of documentation via other means
(e.g., from the vaccine administrator or
their state health department) and been
unsuccessful in doing so. The agency
recognizes that securing vaccination
documentation may be challenging for
some members of the workforce, such as
migrant workers, employees who do not
have access to a computer, or employees
who may not recall who administered
their vaccines (e.g., if the vaccination
was provided at a temporary location,
such as a church, or during a state or
local mass vaccination campaign). Thus,
for employees who have no other means
of obtaining proof of vaccination, the
standard permits employers to accept
attestations meeting the requirements in
paragraph (e)(2)(vi) as proof of
vaccination. However, employers
should explain to their employees that
they need to produce vaccination proof
through the other means listed in
paragraph (e)(2), such as by contacting
the vaccination administrator, if they
are able to do so. Once the employee has
provided a signed and dated attestation
that meets the requirements of
paragraph (e)(2)(vi), the employer no
longer needs to seek out one of the other
forms of vaccination proof for that
employee and, depending on the
content of the attestation, the employer
may consider that employee either fully
or partially vaccinated for purposes of
the ETS.
Recently, there has been evidence of
fraud associated with people attesting to
their vaccination status (Bergal,
September 16, 2021). While employers
may not invite or facilitate fraud, the
ETS does not require employers to
monitor for or detect fraud. By defining
what constitutes acceptable proof of
vaccination under the ETS, OSHA is
ensuring that employers can accept
proof meeting the requirements of
paragraph (e) for purposes of
compliance with the standard. However,
the standard’s requirements for proof of
vaccination are integral to ensuring that
employees are protected appropriately,
either through vaccination (the
preferred and most effective workplace
control in this ETS), or through regular
testing and use of face coverings. Thus,
it is paramount that employees provide
truthful information regarding their
vaccination status.
As discussed in more detail in the
Summary and Explanation for
paragraph (j) (Section VI.J. of this
section), 18 U.S.C. 1001(a), which
provides for fines or imprisonment of
generally up to 5 years for any person
who ‘‘in any matter within the
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jurisdiction’’ of the executive branch
U.S. Government ‘‘knowingly and
willfully’’ engages in any of the
following:
(1) Falsifies, conceals, or covers up by
any trick, scheme, or device a material
fact;
(2) makes any materially false,
fictitious, or fraudulent statement or
representation; or
(3) makes or uses any false writing or
document knowing the same to contain
any materially false, fictitious, or
fraudulent statement or entry.
Similarly, the OSH Act recognizes
that OSHA’s ability to protect workers’
safety and health hinges on truthful
reporting. For that reason section 17(g)
of the OSH Act subjects anyone who
‘‘knowingly makes any false statement,
representation, or certification in any
application, record, report, plan, or
other document filed or required to be
maintained pursuant to this chapter’’ to
criminal penalties. 29 U.S.C. 666(g).
False statements made in any proof
submitted under paragraph (e)(2) of the
standard could fall under either or both
of 18 U.S.C. 1001 or section 17(g) of the
OSH Act. And by requiring a specific
declaration about the truth and accuracy
of employee statements provided under
paragraph (e)(2)(vi), employees who are
unable to provide any means of proof
other than their own attestation are
being made aware that their words are
being held to the same standard of
truthfulness as any other record
presented for proof of vaccination.
OSHA notes that these same
prohibitions on false statements and
documentation can apply to employers.
If an employer knows that proof
submitted by an employee is fraudulent,
and even with this knowledge, accepts
and maintains the fraudulent proof as a
record of compliance with this ETS, it
may be subject to the penalties in 18
U.S.C. 1001 and 17(g) of the OSH Act.
Paragraph (e)(3) provides the
mechanism for employers to determine
vaccination status for employees who
do not submit any of the acceptable
forms of proof of vaccination status.
Under paragraph (e)(3), any employee
who does not provide their employer
with one of the acceptable forms of
proof of vaccination status in paragraph
(e)(2) must be treated as not fully
vaccinated for the purpose of the
standard. An unvaccinated employee
does not need to provide any
documentation regarding vaccination
status under this ETS; however, failing
to provide acceptable proof of
vaccination status will signal the
employer to consider the employee as
not fully vaccinated and to note that as
their status in the roster. For employers
that include COVID–19 testing in their
written policies under paragraph (d),
employees without acceptable proof of
vaccination status must submit to
weekly tests (as required by paragraph
(g)) and wear a face covering (as
required by paragraph (i)).
Paragraph (e)(4) requires the employer
to maintain a record of each employee’s
vaccination status and preserve
acceptable proof of vaccination for each
employee who is fully or partially
vaccinated. As discussed previously, the
employer has various options for
acquiring proof of vaccination from each
employee. An employer may allow
employees to provide a digital copy of
acceptable records, including, for
example, a digital photograph, scanned
image, or PDF of such a record that
clearly and legibly displays the
necessary vaccination information.
However, to be in compliance with
paragraph (e)(4), the employer must
ensure they are able to maintain a
record of each employee’s vaccination
status. Therefore, obtaining an
employee’s vaccination information
verbally would not comply with
paragraph (e)(2) or satisfy the record
maintenance requirements of the
standard. Similarly, the record
maintenance requirements of paragraph
(e)(4) cannot be fulfilled by an employee
merely showing the employer their
vaccination status (e.g., by bringing the
CDC COVID–19 vaccination card to the
workplace and showing it to an
employer representative or showing an
employer representative a picture of the
immunization records on a personal
cellphone). To satisfy paragraph (e)(4),
the employer must retain a copy of the
documentation. As mentioned above,
some states and local governments
utilize QR codes to facilitate proof of
vaccination. This can be an acceptable
form of proof for compliance with the
standard so long as the employer retains
a copy of the information retrieved by
scanning the QR code and maintains
that record. Required records of
vaccination status can be maintained
physically or electronically, but the
employer must ensure they have access
to the records at all times.
In addition to obtaining and
maintaining individual records of each
employee’s vaccination status and
preserving acceptable proof of
vaccination for each employee who is
partially or fully vaccinated, under
paragraph (e)(4) the employer must
maintain a roster of each employee’s
vaccination status, subject to applicable
confidentiality requirements. The roster
must list all employees and clearly
indicate for each one whether they are
fully vaccinated, partially (not fully)
vaccinated, not fully vaccinated because
of a medical or religious
accommodation (see Note to paragraph
(d)), or not fully vaccinated because
they have not provided acceptable proof
of their vaccination status. As noted
previously, any employee that has not
provided acceptable proof of their
vaccination status must be treated as not
fully vaccinated. Although
unvaccinated employees will not have
proof of vaccination status, the standard
requires the employer to include all
employees, regardless of vaccination
status, on the roster.
The roster allows the employer to
easily access the vaccination status for
any employee quickly and easily. This
will be useful should the employer need
to respond to a request from an
employee or employee representative
for the aggregate number of fully
vaccinated employees at a workplace
(along with the total number of
employees at that workplace), as
required under paragraph (l)(2).
Additionally, the roster will help the
employer implement the written policy
developed in accordance with
paragraph (d) and comply with other
requirements of the ETS. And finally,
the roster, which must be provided to
OSHA on request (paragraph (l)(3)), will
aid OSHA’s ability to effectively and
efficiently enforce this ETS.
The records and roster required by
paragraph (e)(4) are considered to be
employee medical records and must be
maintained as such records in
accordance with 29 CFR 1910.1020 and
must not be disclosed except as required
or authorized by this ETS or other
federal law, including the Americans
with Disabilities Act (ADA), 42 U.S.C.
12101 et seq. These records and roster
are not subject to the retention
requirements of 29 CFR
1910.1020(d)(1)(i) but must be
maintained and preserved while this
ETS remains in effect. OSHA considers
vaccination records required by
paragraphs (e)(2) and (e)(4) of the ETS
to be employee medical records
concerning the health status of an
employee and is requiring this
personally identifiable medical
information to be maintained in a
confidential manner. OSHA notes that
under paragraph (e)(4), vaccination
records and rosters are employee
medical records, and must be treated as
employee medical records under 29 CFR
1910.1020, without regard to whether
the records satisfy the definition of
employee medical record at 29 CFR
1910.1020(c)(6)(i).
Paragraph (e) in 29 CFR 1910.1020
includes requirements for access to
employee medical records by
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employees, their designated
representatives, and OSHA. However, as
discussed in more detail below,
paragraph (l) of the ETS includes
specific timeframes within which
employers must make vaccine records
available to employees, OSHA, and
other specified individuals.
Accordingly, the timeframes for
providing access to employee medical
records in 29 CFR 1910.1020(e) do not
apply, and employers must follow the
specific timeframes set forth in
paragraph (l) of the ETS for providing
access to vaccination records.
Additionally, 29 CFR 1910.1020(d)
addresses the preservation of employee
exposure and medical records.
Paragraph (d)(1)(i) in section 1910.1020
generally provides that unless a specific
occupational safety and health standard
provides a different period of time, each
employer must preserve and maintain
employee medical records for at least
the duration of employment plus thirty
(30) years. Paragraph (e)(4) of the ETS
specifically provides that the
vaccination records required by the ETS
are not subject to the retention
requirements of 29 CFR
1910.1020(d)(1)(i). Instead, paragraph
(e)(4) states that vaccination records
must be maintained and preserved only
so long as the ETS remains in effect.
Finally, while the provisions on
timeframes for access to records and the
retention provisions of 29 CFR
1910.1020 do not apply to vaccine
records required by the ETS, other
provisions in that regulation can still
apply. For example, 29 CFR
1910.1020(h) includes requirements for
the transfer of employee medical
records when an employer ceases to do
business.
OSHA recognizes the possibility that
an employer may have already collected
information about the vaccination status
of employees, including proof of
vaccination, prior to the effective date of
this ETS. Under paragraph (e)(5), when
an employer has ascertained employee
vaccination status prior to the effective
date of the ETS through another form of
attestation or proof, and retained
records of that ascertainment, the
employer is exempt from the
requirements in paragraphs (e)(1)–(e)(3).
The exemption applies only for each
employee whose fully vaccinated status
has been documented prior to the
effective date of the standard. For
example, an employer may have asked
each employee to self-report their
vaccination status without requiring the
employee to provide any form of proof.
If that self-reporting was through oral
conversation only, and not documented
in some way, the employer is not
considered to have retained records of
that ascertainment for the purposes of
this ETS. However, if, for example, the
employer had the employees provide
their vaccine information on a dated
form, or through individual emails
retained by the employer, or on an
employer portal specifically created for
employees to provide documentation
status, or the employer created and
retained some other means of
documentation, the employer is
considered to have retained records of
ascertainment for the purposes of this
ETS. Even if the record does not have
all of the elements of the acceptable
forms of proof listed in paragraph (e)(2),
so long as the employer has ascertained
employee vaccination status prior to the
effective date of the ETS through
another form of attestation or proof, and
retained records of that ascertainment,
the employer does not need to re-
determine vaccination status (paragraph
(e)(1)) or obtain proof of vaccination
status (paragraph (e)(2)) for fully
vaccinated employees. For purposes of
paragraph (e)(4), the employer’s records
of vaccination status for each employee
whose fully vaccinated status was
previously documented constitute
acceptable proof of vaccination.
However, the employer must still
develop a roster of each employee’s
vaccination status and include on that
roster the employees for whom it had
previously determined and retained
records of vaccination status. OSHA
notes that if the employer has not
ascertained employee vaccination status
for employees prior to the effective date
of the ETS, then all requirements of
paragraph (e) would apply. And all
requirements of paragraph (e) also apply
with respect to employees for whom the
employer ascertained only partial
vaccination status prior to the effective
date of the ETS.
References
Bergal J. (2021, September 16). Fake Vaccine
Card Sales Have Skyrocketed Since
Biden Mandate. https://
www.pewtrusts.org/en/research-and-
analysis/blogs/stateline/2021/09/16/
fake-vaccine-card-sales-have-
skyrocketed-since-biden-mandate.
(Bergal, September 16, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, October 5). Getting Your
CDC COVID–19 Vaccination Record
Card. https://www.cdc.gov/coronavirus/
2019-ncov/vaccines/vaccination-
card.html. (CDC, October 5, 2021).
New York State Government. (n.d.) Excelsior
Pass and Excelsior Pass Plus. Retrieved
October 4, 2021 from https://
covid19vaccine.health.ny.gov/excelsior-
pass-and-excelsior-pass-plus. (New York
State Government, n.d., Retrieved
October 4, 2021).
State of California. (n.d.) Frequently Asked
Questions. Retrieved October 7, 2021
from https://
myvaccinerecord.cdph.ca.gov/faq. (State
of California, n.d., Retrieved October 7,
2021).
F. Employer Support for Employee
Vaccination
As discussed in the Summary and
Explanation for paragraph (d) (Section
VI.D. of this preamble), as well as in
Grave Danger and Need for the ETS
(Sections III.A. and III.B. of this
preamble), vaccination is the single
most efficient and effective method for
protecting unvaccinated workers from
the grave danger posed by COVID–19.
This emergency temporary standard is
therefore designed to strongly encourage
vaccination. As discussed in detail
below, paragraph (f) requires employers
to support vaccination by providing
employees reasonable time, including
up to four hours of paid time, to receive
each primary vaccination dose, and
reasonable time and paid sick leave to
recover from side effects experienced
following each primary vaccination
dose. For purposes of the requirements
to support vaccination in paragraph (f),
OSHA considers a vaccination series
that meets the criteria in subparagraph
(ii) of the definition of ‘‘fully-
vaccinated’’ (i.e., a heterologous primary
series of such vaccines, receiving doses
of different COVID–19 vaccines as part
of one primary series) to be a primary
vaccination series, along with the
primary vaccination described in
subparagraph (i) of that definition (see
the Summary and Explanation for
paragraph (c), Section VI.C. of this
preamble, for more information on the
definition of fully vaccinated).
Removing logistical barriers to
obtaining vaccination is essential to
increasing workforce vaccination rates,
and one such barrier for many
employees is their lack of time off of
work to receive the vaccine and recover
from any potential side effects (SEIU
Healthcare, February 8, 2021).
Employees’ concerns about missing
work to obtain and recover from a
COVID–19 vaccination dose are well
documented. In a McKinsey survey,
12% of respondents stated that the time
spent away from work to get vaccinated
or due to vaccine side effects was a
barrier to vaccination (Azimi et al.,
April 9, 2021). In a survey conducted of
unvaccinated adults in April 2021, a
fifth of respondents said they were very
or somewhat concerned that they may
need to take time off to go and get the
vaccine, and 48% of respondents said
that they were very or somewhat
concerned that they might miss work if
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the vaccine side effects make them feel
sick (KFF, May 6, 2021). Black and
Hispanic adults were particularly
worried about the potential time
necessary to receive the vaccine and to
recover from vaccine side effects; 64%
of unvaccinated Hispanic adults and
55% of unvaccinated Black adults
expressed concern that they might have
to miss work due to the side effects of
a COVID–19 vaccine, and 30% of
Hispanic adults and 23% of Black
adults were concerned that they might
need to take time off work to get a
COVID–19 vaccine (KFF, May 6, 2021;
KFF, May 17, 2021). News and journal
articles further evince this concern (Roy
et al., December 29, 2020; Cleveland
Documenters, 2021; Rosenberg and
Stein, August 18, 2021).
This concern reflects the fact that
many workers do not have access to
paid time off to receive vaccination or
to recover from side effects. A KFF
survey found that only half of all
workers reported that their employer
provided them with paid time off either
to get a COVID–19 vaccine or to recover
from any side effects (KFF, June 30,
2021). A subsequent KFF survey found
that only about one-third of workers
were sure that their employer offered
them paid time off to get a COVID–19
vaccine and recover from side effects
(KFF, September 28, 2021). Although
employee access to paid sick leave is
less of a concern for employers with 100
or more employees, approximately 12%
of employees in these situations do not
have paid sick leave (BLS, September
2021) and in some cases, employees
may have already exhausted paid sick
leave they have received and would
need additional time from their
employers to recover from vaccine side
effects.
The scarcity of paid time off for
vaccination and side effect recovery is
particularly acute for certain
demographic groups. The June 2021
KFF survey found that only 38% of
Black workers reported getting either
paid time off to get a COVID–19 vaccine
or to recover from side effects, and that
only 41% of workers with household
incomes less than $40,000 annually had
access to such paid time off (KFF, June
30, 2021). Similarly, the September
2021 KFF survey found that lower-wage
workers were particularly unlikely to
report access to paid time off for
vaccination or recovery, with only 23%
of workers whose household incomes
was less than $40,000 reporting that
they could take paid time off to get
vaccinated, and only 28% of that group
reporting that they could take paid time
off to recover from side effects (KFF,
September 28, 2021). Lower-wage
workers’ lack of access to paid time off
for vaccination comports with a
different report indicating that, before
the pandemic, about 65% of the lowest-
wage workers had no access to paid sick
leave, meaning that any time off for
vaccination or recovery would result in
lost wages for those who can least afford
those losses (BLS, September 2021). The
need for paid time off to receive
vaccination is also particularly
important for workers with disabilities
and workers in rural areas because
travel to and from vaccination sites may
take more time or be more logistically
difficult for those populations (National
Safety Council, 2021).
Paying workers for the time spent to
receive vaccination and to recover from
side effects has proven to be an effective
method for increasing vaccination rates.
In June 2021, KFF found that
approximately 75% of employed adults
surveyed who received paid time off to
get the vaccine or to recover from side
effects had received at least one dose of
the vaccine compared to only 51% of
those surveyed who did not receive paid
time off from their employer (KFF, June
30, 2021). KFF also found that
employees who are provided paid time
off and are encouraged by their
employers to get vaccinated are more
likely to get vaccinated, even after
controlling for demographic
characteristics that may impact
vaccination uptake (KFF, June 30, 2021).
Another KFF survey found that 28% of
unvaccinated respondents who did not
want to get the vaccine as soon as
possible said that they would be more
likely to obtain vaccination if their
employer gave them paid time off to get
vaccinated and recover from any side
effects (KFF, May 6, 2021). KFF has also
found that increasing access to paid
leave for vaccination or recovery from
side effects can also help further reduce
disparities in vaccination by age and
income (KFF, September 28, 2021).
In a different survey, paid time off for
vaccination and the recovery period
post-vaccination was the single most-
influential action for encouraging
employee vaccination, with 75% of
respondents indicating that such paid
time off would significantly or
moderately increase the likelihood that
they would get vaccinated (Azimi et al.,
April 9, 2021). Another survey of nearly
9,000 service workers across large
grocery, retail, food service, pharmacy,
and delivery firms, found that
vaccination rates were lower than other
frontline workers who also regularly
work in-person and indoors, and when
employers supported and facilitated
vaccination, such as through providing
paid time off or paid sick leave for
vaccination or for recovery from side
effects, employee vaccination rates were
higher than if no support was provided,
and in May 2021, workers with paid
sick leave were 15% more likely to have
gotten the vaccine than workers without
such leave (Bellew et al., June 2021).
To address this barrier to vaccination,
paragraph (f) requires employers to
support COVID–19 vaccination by
providing each employee with
reasonable time, including up to four
hours of paid time, to receive each
primary vaccination dose, and
reasonable time and paid sick leave to
recover from side effects experienced
following any primary vaccination dose.
Providing this time is essential for all
unvaccinated employees who are
covered by this rule to ensure that they
can receive primary vaccination dose(s)
and recover from side effects without
sacrificing pay or their jobs. In
workplaces where employers implement
a mandatory vaccination policy in
accordance with paragraph (d)(1) of this
rule, the requirements of paragraph (f)
ensure that employees are able to
comply with the mandatory vaccination
policy without concern about missing
work to do so. In workplaces where the
employer opts out of implementing a
mandatory vaccination policy in
accordance with paragraph (d)(2), the
requirements of paragraph (f) encourage
employees to choose vaccination, and
ensure that employees who choose to
obtain vaccination, rather than be
regularly tested for COVID–19 and wear
a face covering in most situations when
they work near others, are not penalized
for making that choice.
Paragraph (f)(1) requires employers to
support COVID–19 vaccination for each
employee by providing reasonable time
to each employee during work hours for
each of their primary vaccination
dose(s), including up to four hours of
paid time, at the employee’s regular rate
of pay, for the purposes of vaccination.
Reasonable time may include, but is not
limited to, time spent during work
hours related to the vaccination
appointment(s), such as registering,
completing required paperwork, all time
spent at the vaccination site (e.g.,
receiving the vaccination dose, post-
vaccination monitoring by the vaccine
provider), and time spent traveling to
and from the location for vaccination
(including travel to an off-site location
(e.g., a pharmacy), or situations in
which an employee working remotely
(e.g., telework) or in an alternate
location must travel to the workplace to
receive the vaccine).
Employers are not, however, obligated
by this ETS to reimburse employees for
transportation costs (e.g., gas money,
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train/bus fare, etc.) incurred to receive
the vaccination. This could include the
costs of travel to an off-site vaccination
location (e.g., a pharmacy) or travel from
an alternate work location (e.g.,
telework) to the workplace to receive a
vaccination dose.
Because employers are required to
provide reasonable time for vaccination
during work hours, if an employee
chooses to receive a primary vaccination
dose outside of work hours, employers
are not required to grant paid time to the
employee for the time spent receiving
the vaccine during non-work hours.
However, even if employees receive a
primary vaccination dose outside of
work hours, employers must still afford
them reasonable time and paid sick
leave to recover from side effects that
they experience during scheduled work
time in accordance with paragraph
(f)(2).
An employer may make other efforts
to facilitate vaccination of its employees
by, for example, hosting a vaccine clinic
at the workplace (e.g., mobile trailer) or
partnering with another entity, such as
a pharmacy or healthcare provider, so
that employees can be vaccinated at the
workplace or at an off-site location. If an
employer chooses to make the vaccine
available to its employees, it must
support full vaccination (i.e., provide all
doses in a primary vaccination, as
applicable), and assure the availability
of reasonable time and paid time to each
employee to receive the full primary
vaccination, and reasonable time and
paid sick leave to recover from side
effects that they may experience. Any
additional costs incurred by the
employer to bring vaccination on-site
would be covered by the employer,
though such an approach would likely
reduce the amount of paid time needed
for vaccine administration (but not side
effects) because of reduced employee
travel time.
Paragraph (f)(1) specifies that the
amount of paid time that an employer
is required to provide each employee to
receive each primary vaccination dose is
capped at four hours. OSHA has
determined that four hours would
provide reasonable time for most
employees to get each vaccination dose.
Vaccines are widely available to the
public at clinics, pharmacies, and other
locations across the country (see CDC,
October 8, 2021). Providing four hours
of paid time to receive each primary
vaccination dose is consistent with
OSHA’s presumption of the amount of
time needed to receive a vaccination
dose in the June 2021 Healthcare ETS
(86 FR 32598), and with the U.S. Office
of Personnel Management’s guidance to
federal government agencies on the use
of the emergency paid leave created for
federal employees in the American
Rescue Plan Act of 2021 (Public Law
117–2), which encouraged agencies to
offer up to four hours of administrative
leave per dose to cover time spent
getting a vaccine dose, plus additional
time if reasonably necessary, instead of
having employees use emergency paid
leave (OPM, April 29, 2021). OSHA
expects that most employees will need
less than four hours to receive a
vaccination dose.
The maximum of four hours of paid
time that employers must provide under
paragraph (f)(1)(ii) for the
administration of each primary
vaccination dose cannot be offset by any
other leave that the employee has
accrued, such as sick leave or vacation
leave. OSHA is concerned that
employees forced to use their sick leave
or vacation leave for vaccination would
have a disincentive to gaining the health
protection of vaccination. Employers
must pay employees for up to four hours
of time at the employee’s regular rate of
pay. This may be achieved by paying for
the time to be vaccinated as work hours
for up to four hours. Requiring
employers to pay for vaccine
administration is consistent with
OSHA’s normal approach of requiring
employers to bear the costs of
compliance with safety and health
standards.
OSHA understands that employees
may need much less than four hours to
receive a primary vaccination dose, for
example, if vaccinations are offered on-
site. However, OSHA also understands
that, in some circumstances, an
employee may need more than four
hours to receive a primary vaccination
dose, in which case the additional time,
as long as it is reasonable, would be
considered unpaid but protected leave.
The employer cannot terminate the
employee if they use a reasonable
amount of time to receive their primary
vaccination doses. The employee may
use other leave time that they have
available (e.g., sick leave or vacation
time) to cover the additional time
needed to receive a vaccination dose
that would otherwise be unpaid.
Paragraph (f)(2) also requires
employers to support COVID–19
vaccination for each employee by
providing reasonable time and paid sick
leave to recover from side effects
experienced following any primary
vaccination dose to each employee for
each dose. The paid sick leave can be
in the form of an employee’s accrued
sick leave, if available. If the employee
does not have available sick leave, leave
must be provided for this purpose.
Although some individuals
experience no side effects from COVID–
19 vaccination doses, the CDC has
identified a range of side effects that
other individuals may experience
following a vaccination dose (CDC,
April 2, 2021; CDC, September 30,
2021). Side effects may affect
individuals’ ability to engage in daily
activities, are typically mild-to-
moderate in severity, and usually go
away in a few days. Common side
effects include pain, redness, and
swelling at the site of injection, and
systemic side effects throughout the
body, including tiredness, headache,
muscle pain, chills, fever, and nausea.
Side effects may be sufficiently severe to
require the employee to take sick leave
from work, but will rarely extend
beyond a few days. One study found
that ‘‘unanticipated paid administrative
leave was only required for 4.9% and
19.79% of individuals after the first and
second doses of vaccine, respectively’’
(Levi et al., September 25, 2021).
Employees would not typically be
expected to need leave solely to address
redness or swelling at the site of
injection, but it is not uncommon for
vaccine recipients to require some
recovery time for many of the other side
effects. The CDC notes, however, that
cough, shortness of breath, runny nose,
sore throat, or loss of taste or smell are
not consistent with post-vaccination
symptoms and instead may be
symptoms of COVID–19 or another
infection (CDC, April 2, 2021).
If an employee already has accrued
paid sick leave, an employer may
require the employee to use that paid
sick leave when recovering from side
effects experienced following a primary
vaccination dose. Additionally, if an
employer does not specify between
different types of leave (i.e., employees
are granted only one type of leave), the
employer may require employees to use
that leave when recovering from
vaccination side effects. If an employer
provides employees with multiple types
of leave, such as sick leave and vacation
leave, the employer can only require
employees to use the sick leave when
recovering from vaccination side effects.
Employers cannot require employees to
use advanced sick leave to cover
reasonable time needed to recover from
vaccination side effects under paragraph
(f)(2). An employer may not require an
employee to accrue negative paid sick
leave or borrow against future paid sick
leave to recover from vaccination side
effects. In other words, the employer
cannot require an employee to go into
the negative for paid sick leave if the
employee does not have accrued paid
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1 Azimi T et al. (2021, April 9). Getting to work:
Employers’ role in COVID–19 vaccination. https://
www.mckinsey.com/industries/pharmaceuticals-
and-medical-products/our-insights/getting-to-work-
employers-role-in-covid-19-vaccination# (Azimi et
al., April 9, 2021)
sick leave when they need to recover
from side effects experienced following
a primary vaccination dose. Neither the
paid time required to receive any
vaccine dose(s) nor the paid sick leave
required to recover from side effects
experienced following any vaccination
dose are retroactive requirements for
vaccine dose(s) received prior to the
promulgation of this ETS.
Paragraph (f)(2) requires employers to
provide reasonable time and paid sick
leave to employees to recover from side
effects experienced following a primary
vaccination dose, but does not specify
the amount of paid sick leave that the
employer is required to provide for that
purpose. Employers may set a cap on
the amount of paid sick leave available
to employees to recover from any side
effects, but the cap must be reasonable.
CDC notes that although some people
have no side effects, side effects, if
experienced, should go away in a few
days (CDC, September 30, 2021).
Another study found that the average
unanticipated paid administrative leave
required by individuals experiencing
side effects was around two days (1.66
days for the first dose and 1.39 days for
the second dose) (Levi et al., September
25, 2021). Generally, OSHA presumes
that, if an employer makes available up
to two days of paid sick leave per
primary vaccination dose for side
effects, the employer would be in
compliance with this requirement.
When setting the cap, an employer
would not be expected to account for
the unlikely possibility of the
vaccination resulting in a prolonged
illness in the vaccinated employee (e.g.,
a severe allergic reaction).
OSHA is aware that other federal,
state, or local laws, or collective
bargaining agreements, may require
employers to provide employees
additional paid time for vaccination
and/or paid sick leave to recover from
vaccination side effects. Where such an
overlap exists, the requirements of this
standard are satisfied so long as the
employer provides each employee
reasonable time and four hours of paid
time to receive each primary
vaccination dose, and reasonable time
and paid sick leave to recover from side
effects experienced following a primary
vaccination dose.
References
Azimi T et al. (2021, April 9). Getting to
work: Employers’ role in COVID–19
vaccination.1(Azimi et al., April 9, 2021)
Bellew E et al. (2021, June). Half of service
sector workers are not yet vaccinated for
COVID–19: What gets in the way? The
Shift Project: Research Brief. https://
shift.hks.harvard.edu/wp-content/
uploads/2021/06/Vax_Brief_6.28.21-
2.pdf. (Bellew et al., June 2021)
Centers for Disease Control and Prevention
(CDC). (2021, April 2). Post-vaccination
considerations for workplaces. https://
www.cdc.gov/coronavirus/2019-ncov/
community/workplaces-businesses/
vaccination-considerations-for-
workplaces.html. (CDC, April 2, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, September 30). Possible
side effects after getting a COVID–19
vaccine. https://www.cdc.gov/
coronavirus/2019-ncov/vaccines/expect/
after.html. (CDC, September 30, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, accessed October 8). We
can do this: Vaccines.gov website.
https://www.vaccines.gov/. (CDC,
October 8, 2021)
Cleveland Documenters. (2021). Why some
Clevelanders are still on the fence or not
getting vaccinated: Voices on the
vaccine. The Cleveland Observer.
https://www.freshwatercleveland.com/
street-level/VaccineVoice050521.aspx.
(Cleveland Documenters, 2021)
Kaiser Family Foundation (KFF). (2021, May
6). KFF COVID–19 Vaccine Monitor:
April 2021. https://www.kff.org/
coronavirus-covid-19/poll-finding/kff-
covid-19-vaccine-monitor-april-2021/.
(KFF, May 6, 2021)
Kaiser Family Foundation (KFF). (2021, May
17). How employer actions could
facilitate equity in COVID–19
vaccinations. https://www.kff.org/policy-
watch/how-employer-actions-could-
facilitate-equity-in-covid-19-
vaccinations/. (KFF, May 17, 2021)
Kaiser Family Foundation (KFF). (2021, June
30). KFF COVID–19 Vaccine Monitor:
June 2021. https://www.kff.org/report-
section/kff-covid-19-vaccine-monitor-
june-2021-findings/. (KFF, June 30, 2021)
Kaiser Family Foundation (KFF). (2021,
September 28). KFF COVID–19 Vaccine
Monitor: September 2021. https://
www.kff.org/coronavirus-covid-19/poll-
finding/kff-covid-19-vaccine-monitor-
september-2021/. (KFF, September 28,
2021)
Levi ML et al. (2021, September 25). COVID–
19 mRNA vaccination, reactogenicity,
work-related absences and the impact on
operating room staffing: A cross-
sectional study. Perioperative Care and
Operating Room Management preprint.
https://doi.org/10.1016/
j.pcorm.2021.100220. (Levi et al.,
September 25, 2021)
National Safety Council. (2021). A Year in
Review, and What’s Next: COVID–19
Employer Approaches and Worker
Experiences. https://www.nsc.org/
faforms/safer-year-one-final-report.
(National Safety Council, 2021)
Rosenberg E and Stein J. (2021, August 18).
America’s failure to pay workers time off
undermines vaccine campaign,
according to surveys, policy experts.
Washington Post. https://
www.washingtonpost.com/us-policy/
2021/08/16/paid-leave-covid-vaccine/.
(Rosenberg and Stein, August 18, 2021)
Roy B et al. (2020, December 29). Health Care
Workers’ Reluctance to Take the COVID–
19 Vaccine: A Consumer-Marketing
Approach to Identifying and Overcoming
Hesitancy.NEJM Catalyst. https://
catalyst.nejm.org/doi/pdf/10.1056/
CAT.20.0676. (Roy et al., December 29,
2020)
SEIU Healthcare. (2021, February 8).
Research shows 81% of healthcare
workers willing to take COVID–19
vaccines but personal financial pressures
remain a significant barrier for uptake.
https://www.newswire.ca/news-releases/
research-shows-81-of-healthcare-
workers-willing-to-take-covid-19-
vaccines-but-personal-financial-
pressures-remain-a-significant-barrier-
for-uptake-888810789.html. (SEIU
Healthcare, February 8, 2021)
United States Bureau of Labor Statistics
(BLS). (2021, September). National
Compensation Survey: Employee
Benefits in the United States, March
2021. https://www.bls.gov/ncs/ebs/
benefits/2021/employee-benefits-in-the-
united-states-march-2021.pdf. (BLS,
September, 2021)
United States Office of Personnel
Management (OPM). (2021, April 29).
American Rescue Plan: COVID–19
Emergency Paid Leave for Federal
Employees. https://chcoc.gov/sites/
default/files/
Attachment%205%20COVID–
19%20Emergency%20Paid%20
Leave%20Questions%20
and%20Answers_0.pdf. (OPM, April 29,
2021)
G. COVID–19 Testing for Employees
Who Are Not Fully Vaccinated
Paragraph (g) of this ETS addresses
employers’ obligations with respect to
employees who are not fully vaccinated,
including the requirement to ensure
unvaccinated employees are tested for
COVID–19. As explained in Need for the
ETS (Section III.B. of this preamble),
OSHA strongly prefers that employers
implement written mandatory
vaccination policies because that is the
most effective and efficient workplace
control available for preventing the
spread of COVID–19. However, this ETS
is also necessary to protect workers who
remain unvaccinated through required
regular testing, use of face coverings,
and removal of infected employees from
the workplace, and to protect other
workers from the greater likelihood that
unvaccinated workers may spread
COVID–19 in the workplace. People
who are unvaccinated are at increased
risk of becoming infected with COVID–
19 and are more likely to spread the
disease when compared to people who
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are fully vaccinated (CDC, September
15, 2021). Additionally, people who are
unvaccinated are more likely to
experience severe clinical outcomes if
they become infected than people who
are vaccinated (Lopez Bernal et al., July
21, 2021). Therefore, routine COVID–19
testing of unvaccinated employees is
necessary to identify employees with
COVID–19 so they can be removed from
the workplace to prevent transmission
to other employees and to facilitate
early medical intervention for infected
employees when appropriate.
Routine testing of unvaccinated
employees is necessary regardless of
whether the unvaccinated employees
have symptoms because SARS–CoV–2
infection is often attributable to
asymptomatic and/or pre-symptomatic
transmission (i.e., individuals who are
not exhibiting symptoms) (Bender et al.,
February 18, 2021; Klompas, September
2021; Johansson et al., January 7, 2021;
Byambasuren et al., December 11, 2020).
Although less effective and efficient
than vaccination, the CDC has
recognized regularly testing
unvaccinated employees for COVID–19
as a useful tool for identifying
asymptomatic and/or pre-symptomatic
infected individuals so that they can be
isolated (CDC, May 4, 2021; CDC,
October 7, 2021). In contrast, the CDC
recommends that fully vaccinated
employees with no symptoms and no
known exposure should be exempt from
routine testing programs (CDC, May 4,
2021). Additional information about the
risks of COVID–19 transmission in
vaccinated and unvaccinated workers is
discussed in Grave Danger (Section
III.A. of this preamble).
Testing for COVID–19 can broadly be
divided into two categories: diagnostic
testing and screening testing. The
purpose of diagnostic testing is to
identify current infection when a person
has signs or symptoms consistent with
COVID–19, or when a person is
asymptomatic but has recent known or
suspected exposure to SARS–CoV–2.
The information provided by diagnostic
testing can be used by a healthcare
provider to diagnose or treat a patient.
The purpose of screening testing is to
identify infected people who are
asymptomatic and do not have known,
suspected, or reported exposure to
COVID–19. Screening testing helps to
identify unknown cases both so that
measures can be taken to prevent further
transmission to others (e.g., removal
from the workplace and home isolation)
and also to allow infected, but
asymptomatic, people to begin medical
treatment, as appropriate, so they can
better avoid the most severe outcomes of
COVID–19 (e.g., high risk individuals
seeking monoclonal antibody treatment
or anti-viral medication). Although the
testing required in paragraph (g)(1) of
this ETS is screening testing, both
screening and diagnostic testing can
help prevent the spread of COVID–19.
Paragraph (g) does not preclude
additional diagnostic testing if an
employee shows signs or symptoms
consistent with COVID–19 or has recent
known or suspected exposure to SARS–
CoV–2.
Both screening and diagnostic testing
involve the use of viral COVID–19 tests
to detect current infection, as opposed
to antibody COVID–19 tests, which are
used to detect whether a person has
antibodies for COVID–19. A positive
antibody test indicates someone has
antibodies to SARS–CoV–2, the virus
that causes COVID–19, which could
either be the result of a prior infection
with the virus or vaccination against
COVID–19 (FDA, May 19, 2021; CDC,
September 10, 2021). Viral tests for
current infection fall into two
categories: Nucleic acid amplification
tests (NAATs) and antigen tests. The
Food and Drug Administration (FDA)
(October 6, 2021) has issued a number
of Emergency Use Authorizations
(EUAs) for viral COVID–19 tests. It is
important to note that OSHA’s
definition of ‘‘COVID–19 test’’ requires
that COVID–19 tests be cleared,
approved, or authorized by the FDA and
administered in accordance with
authorized instructions, with the noted
exception of not allowing tests that are
both self-administered and self-read by
the employee unless observed by the
employer or an authorized telehealth
proctor. In this regard, OSHA recognizes
that it is within FDA’s authority and
jurisdiction to help to assure the
appropriate safety, efficacy, and
accuracy of COVID–19 tests. The
definition of ‘‘COVID–19 test’’ has
previously been discussed in the
Summary and Explanation for
paragraph (c) (Section VI.C. of this
preamble). Additional information
about the type of COVID–19 tests that
would satisfy the requirements of
paragraph (g) are available in that
section of this preamble.
As explained above, the most effective
and efficient workplace control for
preventing the spread of COVID–19 is
vaccination and OSHA strongly prefers
that employers implement written
mandatory vaccination policies.
However, where employers have
unvaccinated employees, regular
COVID–19 screening tests are necessary
so infected employees can be identified
and removed from the workplace to
prevent workplace transmission and to
facilitate early medical intervention,
when appropriate. In addition to being
more likely to become infected with
COVID–19, people who are
unvaccinated are more likely to
experience severe clinical outcomes
from COVID–19 than fully vaccinated
people (see Grave Danger, Section III.A.
of this preamble). In a recent CDC
Morbidity and Mortality Weekly Report
(MMWR) out of Los Angeles County, the
SARS–CoV–2 infection rate among
unvaccinated persons was 4.9 times and
the hospitalization rate was 29.2 times
the rates among fully vaccinated
persons (Griffin et al., August 27, 2021).
As explained below, regular screening
testing of individuals for COVID–19 is
an effective method of identifying
asymptomatic and pre-symptomatic
infections. Screening testing of
unvaccinated employees is necessary
because symptom and temperature
checks will miss both asymptomatic and
pre-symptomatic infections, which is a
serious problem because pre-
symptomatic and asymptomatic
transmission are significant drivers of
the continued spread of COVID–19
(Johansson et al., January 7, 2021). Once
infected employees are identified, they
can be removed from the workplace,
thereby reducing virus transmission to
other employees.
Several studies have indicated that
the time from exposure to becoming
contagious for COVID–19 is shorter than
the time for symptoms to develop
(incubation period), meaning that
individuals can transmit SARS–CoV–2
before they begin to feel ill (i.e., pre-
symptomatic transmission) (Nishiura et
al., March 4, 2020; Tindale et al., June
22, 2020). Pre-symptomatic individuals
can transmit the virus to others before
they know they are sick. These
individuals should isolate but would
not know to do so if they are unaware
of their infection. It is also possible for
individuals to be infected and
subsequently transmit the virus without
ever exhibiting symptoms. This is called
asymptomatic transmission. A meta-
analysis of 351 studies from January 1,
2020, to April 2, 2021, estimated that
42.8% of those infected with the SARS–
CoV–2 virus exhibited no symptoms at
the time of testing and so had either
asymptomatic or pre-symptomatic
infections (Sah et al., August 10, 2021).
In another meta-analysis of studies,
which included people of all ages at risk
of contracting COVID–19 who were
tested regardless of presence or absence
of symptoms, seventeen percent of cases
never developed symptoms during
entire COVID–19 infection (i.e.,
asymptomatic infection). In those
studies, a diagnosis was confirmed with
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a positive result on a RT–PCR and all
positive cases had a follow-up period of
at least seven days to distinguish
asymptomatic cases from pre-
symptomatic cases (Byambasuren et al.,
December 11, 2020). In another study,
researchers used a decision analytical
model to assess the proportion of
SARS–CoV–2 transmission from pre-
symptomatic, never symptomatic, and
symptomatic individuals in the
community. Based on their modeling,
they predicted that 59% of transmission
came from asymptomatic transmission,
including 35% from pre-symptomatic
individuals and 24% from individuals
who never develop symptoms
(Johansson et al., January 7, 2021).
The existence of pre-symptomatic and
asymptomatic infections pose serious
challenges to containing the spread of
SARS–CoV–2. Although the risk of
asymptomatic transmission is 42%
lower than from symptomatic COVID–
19 patients (Byambasuren et al.,
December 11, 2020), asymptomatic
transmission may result in more
transmissions than symptomatic cases
because asymptomatic persons are less
likely to be aware of their infection and
can unknowingly continue to spread the
disease to others (Sah et al., August 10,
2021). The challenge of containing pre-
symptomatic and asymptomatic SARS–
CoV–2 transmission is amplified among
unvaccinated individuals because, as
explained above, they are more likely to
become infected with COVID–19 in the
first place.
Because unvaccinated employees are
at higher risk of COVID–19 infection
and COVID–19 transmission among
individuals without symptoms is a
significant driver of the spread of
COVID–19, OSHA has determined it is
necessary to prevent the pre-
symptomatic and asymptomatic
transmission of COVID–19 from
unvaccinated workers, through a
requirement for weekly screening
testing. Screening testing with antigen
tests is a rapidly evolving and important
tool that can be used to reduce the
spread of SARS–CoV–2 in the
workplace, particularly when coupled
with other COVID–19 prevention and
control measures (e.g., workplace
removal of infected persons, proper use
of face coverings) (Schulte et al., May
19, 2021). The CDC recommends
screening testing of unvaccinated
asymptomatic workers as a useful tool
to detect COVID–19 and stop
transmission quickly. Screening testing
is particularly useful in areas with
moderate to high community
transmission of COVID–19, which is
currently the overwhelming majority of
the United States (CDC, October 7,
2021). In a study with a well-defined
population of SARS–CoV–2 infected
individuals, researchers found that
frequent testing (i.e., at least twice per
week) maximizes the likelihood of
detecting infected individuals.
However, even when used weekly, rapid
antigen tests still had a 76% probability
of detection (i.e., weekly rapid antigen
tests correctly identified 76% of true
positive infected COVID–19
individuals) (Smith et al., September 15,
2021). By identifying pre-symptomatic
and asymptomatic unvaccinated
employees, employers can remove them
from the workplace to prevent those
employees from spreading SARS–CoV–
2 to other employees. More information
about the removal requirements in this
ETS is available in the Summary and
Explanation for paragraph (h) (Section
VI.H. of this preamble).
Since the incubation period for
COVID–19 can be up to 14 days, the
CDC recommends that screening testing
be conducted at least weekly in non-
healthcare workplaces (CDC, October 7,
2021; CDC, May 4, 2021). Other
researchers also recognize the
effectiveness of weekly screening testing
to control surges of COVID–19
infections (Larremore, January 1, 2021).
Consequently, in workplaces with
unvaccinated employees, OSHA has set
the minimum frequency of testing
unvaccinated workers at seven days
because the agency expects that it will
be effective in slowing the spread of
COVID–19 in those workplaces, when
used in tandem with face coverings
(paragraph (i)) and removal of infected
individuals (paragraph (h)). OSHA
emphasizes that each of these infection
controls provides some protection from
COVID–19 by itself, but that they work
best when used together, layering their
protective impact to boost overall
effectiveness. Although some studies
have shown that more regular screening
testing (e.g., twice weekly) would
identify even more cases, OSHA has
decided to require testing only on a
weekly basis. This is in line with the
CDC recommendations, and as noted
above the evidence shows that this
frequency is effective in detecting
asymptomatic and pre-symptomatic
cases. A more frequent testing schedule
would result in significant additional
costs, and OSHA is hesitant to impose
these costs and depart from CDC
recommendations without a fuller
record generated through the benefit of
notice and comment rulemaking. OSHA
seeks comment on this issue.
Nonetheless, it should be noted that
nothing in this rule prevents screening
testing from being conducted more
frequently based on factors such as the
level of community transmission,
workplace experience with outbreaks,
and type of workplace (e.g., specific
workplace factors such as high volume
retail or critical infrastructure sector).
Early detection of COVID–19-positive
employees through screening testing of
unvaccinated employees also facilitates
early medical intervention, when
appropriate, to avoid the most severe
health outcomes associated with
COVID–19. Early effective treatment of
disease can help avert progression to
more serious illness, especially for
patients at high risk of disease
progression and severe illness, with the
additional benefit of reducing the
burden on healthcare systems (CDC,
December 4, 2021). For example, anti-
SARS–CoV–2 monoclonal antibodies
have been shown to reduce the risk of
hospitalization and death in the
outpatient setting in those with mild to
moderate COVID–19 symptoms and
certain risk factors for disease
progression. Treatment should be
started as soon as possible after the
patient receives a positive result on a
COVID–19 test and within 10 days of
symptom onset (NIH, September 24,
2021). Any COVID–19 medical
treatment should be used in accordance
with a licensed healthcare provider. The
screening tests required by this rule will
facilitate such treatment.
Pursuant to paragraph (g)(1)(i),
covered employers must ensure that
each employee who is not fully
vaccinated and reports at least once
every seven days to a workplace where
other individuals (e.g., coworkers,
customers) are present: (A) Is tested for
COVID–19 at least once every seven
days; and (B) provides documentation of
the most recent COVID–19 test result to
the employer no later than the 7th day
following the date on which the
employee last provided a test result.
Employers must ensure these
unvaccinated employees are tested at
least once every seven calendar days,
regardless of their work schedule. For
example, an unvaccinated part-time
employee who is scheduled to work
only every Monday and Tuesday must
still be tested at least once every seven
days. Because employees must provide
documentation of their most recent
COVID–19 test results to their
employers no later than the 7th day
following the date on which they last
provided a test result, employees may
want to set a schedule for their testing
(e.g., get a COVID–19 test every
Wednesday). A consistent testing day
may help employees ensure their
documentation is provided every seven
calendar days.
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Paragraph (g)(1)(ii) addresses
situations where an employee does not
report to a workplace where other
individuals, such as coworkers or
customers, are present during a period
of seven or more days (e.g., when an
employee is teleworking for an extended
period of time). In such cases, the
employer must ensure the employee is
tested for COVID–19 within seven days
prior to returning to the workplace and
provides documentation of that test
result to the employer upon return to
the workplace. For example, if an
unvaccinated office employee has been
teleworking for two weeks but must
report to the office, where other
employees will be present (e.g.,
coworkers, security officers, mailroom
workers), on a specific Monday to copy
and fax documents, that employee must
receive a COVID–19 test within the
seven days prior to the Monday and
provide documentation of that test
result to the employer upon return to
the workplace. The employee’s test
must occur within the seven days before
the Monday the employee is scheduled
to report to the office, but it also must
happen early enough to allow time for
the results to be received before
returning to the workplace. Similarly,
unvaccinated new hires would need to
be tested for COVID–19 within seven
days prior to reporting to a workplace
where other employees will be present
and provide documentation of their test
results no later than arrival on their first
day of work. Since point-of-care testing
that uses an antigen test allows for
results within minutes, OSHA does not
expect that scheduling tests or
providing results to employers will be
an impediment.
OSHA chose the seven-day period for
employees returning to work after more
than a week away from the workplace
based on the evidence noted above
about the effectiveness of testing at
seven-day intervals. While it considered
using a shorter time period in this
situation, OSHA concluded that it
would be less confusing for employers
to use a uniform time period for both
situations. OSHA was concerned that
requiring different time periods in the
two situations would cause confusion
among both employees and supervisors
implementing the program that would
undermine the effectiveness of the
testing scheme. OSHA seeks comment
on this issue.
An employer has some discretion
regarding how to satisfy its obligations
under paragraph (g)(1), but those
policies and procedures must be
detailed in the employer’s written
policy pursuant to paragraph (d)(2) of
this ETS. For example, the employer
must specify how testing will be
conducted (e.g., testing provided by the
employer at the workplace, employees
independently scheduling tests at point-
of-care locations, etc.). The employer
must also specify in their policy how
employees should provide their COVID–
19 test results to the employer (e.g., an
online portal, to the human resources
department). The Summary and
Explanation for paragraph (d) (Section
VI.D. of this preamble) provides
additional information regarding the
requirements of paragraph (d)(2) of this
ETS. Test results given to the employer
must contain information that identifies
the worker (i.e., full name plus at least
one other identifier, such as date of
birth), the specimen collection date, the
type of test, the entity issuing the result
(e.g., laboratory, healthcare entity), and
the test result.
If an employer is notified that an
employee has a positive screening test,
the employer must remove that
employee from the workplace pursuant
to paragraph (h)(2) of this ETS. The
employee should quarantine and the
employer must not allow the employee
to return to the workplace until they
meet the requirements in paragraphs
(h)(2)(i) through (iii). More discussion of
employee notification to their employer
of a COVID–19 positive status and
removal requirements is available in the
Summary and Explanation for
paragraph (h) (Section VI.H. of this
preamble).
OSHA expects that most screening
testing will be antigen testing that is
conducted at point-of-care locations due
to the reduced cost and faster processing
time when compared to NAAT testing
in laboratories. Most NAATs need to be
processed in a laboratory with variable
time to results (approximately 1–2
days). In contrast, most antigen tests can
be processed at the point of care with
results available in about 15–30 minutes
(CDC, October 7, 2021). Rapid point-of-
care tests are administered in various
settings, such as: Physician offices,
urgent care facilities, pharmacies,
school health clinics, workplace health
clinics, long-term care facilities and
nursing homes, and at temporary
locations, such as drive-through sites
managed by local organizations. As
explained above, COVID–19 tests that
are both self-administered and self-read
do not meet the definition of ‘‘COVID–
19 test’’ in this ETS (unless observed by
the employer or an authorized
telehealth proctor) and therefore do not
satisfy the testing requirements of
paragraph (g).
Because antigen testing in point-of-
care locations will typically produce
results within minutes, the use of
antigen testing should not result in an
inability to provide the employer with
test results in a timely fashion.
However, the agency recognizes that
where the employee or employer uses
an off-site laboratory for testing, there
may be delays beyond the employee’s or
employer’s control. In the event that
there is a delay in the laboratory
reporting results and the employer
permits the employee to continue
working, OSHA will look at the pattern
and practice of the individual employee
or the employer’s testing verification
process and consider refraining from
enforcement where the facts show good
faith in attempting to comply with the
standard.
OSHA has determined that employers
may use pooling procedures to satisfy
the requirements of screening testing
under paragraph (g)(1). Pooling (also
referred to as pool testing or pooled
testing) means combining the same type
of specimen from several people and
conducting one laboratory test on the
combined pool of specimens to detect
SARS–CoV–2 (e.g., four samples may be
tested together, using only the resources
needed for a single test). The advantages
of pooling include preserving testing
resources, reducing the amount of time
required to test large numbers of
specimens (increasing throughput), and
lowering the overall cost of testing
(CDC, June 30, 2021).
If pooling procedures are used and a
pooled test result comes back negative,
then all the specimens can be presumed
negative with the single test. In other
words, all of the employees who
provided specimens for that pool test
can be assumed to have a negative test
result for SARS–CoV–2 infection.
Therefore, documentation of the
negative pooled test result would satisfy
the paragraph (g)(1) documentation
requirement for each employee in the
pool and no additional testing is
necessary. However, if the pooled test
result is positive, immediate additional
testing would be necessary to determine
which employees are positive or
negative. Each of the original specimens
collected in the pool must be tested
individually to determine which
specimen(s) is (are) positive. If original
specimens from the workers in a pooled
test with a positive result are
insufficient to be subsequently tested
individually, those workers in the
positive pool would need to be
immediately re-swabbed and tested. The
individual employee test results would
be necessary to satisfy the employee
documentation requirements of
paragraph (g)(1). Where pooled testing is
used (in accordance with paragraph
(g)(1)), CDC and FDA procedures and
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recommendations for implementing
screening pooled tests should be
followed (CDC, June 30, 2021; FDA,
August 24, 2020). OSHA notes that only
some tests are authorized for pooled
testing, and should be performed per the
authorization.
In a note to paragraph (g)(1), OSHA
explains that this section does not
require the employer to pay for any
costs associated with testing. As
explained in Pertinent Legal Authority,
Section II. of this preamble, the OSH
Act authorizes OSHA to require
employers to bear the costs of
compliance with occupational safety
and health standards, but OSHA has
discretion to decide whether to impose
certain costs—such as those related to
medical examinations or other tests—on
employers ‘‘[w]here [it determines that
such costs are] appropriate.’’ 29 U.S.C.
655(b)(7). OSHA has commonly
required employers to bear the costs of
compliance with standards as a cost of
doing business, including requiring
employers to bear the costs of medical
examinations and procedures (see, e.g.,
29 CFR 1910.1018(n)(1)(i) (inorganic
arsenic standard requires employers to
ensure that medical examinations and
procedures are provided ‘‘without cost
to the employee’’); see also United
Steelworkers, 647 F.2d at 1229–31
(discussing Lead standard’s medical
removal provisions and OSHA’s
authority for imposing cost of medical
removal on employers)). Requiring
employers to bear the costs of
compliance makes it more likely that
employees will take advantage of
workplace protections (see 86 FR
32605). For example, employees are
more likely to use personal protective
equipment (PPE) when employers
provide the PPE to their employees at
no cost (see 72 FR 64342, 64344).
In this ETS, OSHA has largely
required employers to bear the costs of
compliance, including the typical costs
associated with vaccination, but has
determined that it would not be
appropriate to impose on employers any
costs associated with COVID–19 testing
for employees who choose not to be
vaccinated. As explained in Need for
the ETS, Section III.B. of this preamble,
this ETS is designed to strongly
encourage vaccination because
vaccination is the most efficient and
effective control for protecting
unvaccinated workers from the grave
danger posed by COVID–19. COVID–19
testing is only required under the ETS
where an employee has made an
individual choice to forgo vaccination
and pursue a less protective option.
Given the superior protectiveness of
vaccination, and OSHA’s intent for this
ETS to strongly encourage vaccination,
requiring employers to bear the costs of
COVID–19 testing would be counter-
productive. As mentioned above,
requiring employers to pay for
workplace protections makes it more
likely that employees will take
advantage of that protection, and in this
ETS, OSHA intends to strongly
encourage employees to choose
vaccination, not regular COVID–19
testing. Because employees who choose
to remain unvaccinated will generally
be required to pay for their own COVID–
19 testing, this standard creates a
financial incentive for those employees
to become fully vaccinated and avoid
that cost.
Although this ETS does not require
employers to pay for testing, employer
payment for testing may be required by
other laws, regulations, or collective
bargaining agreements or other
collectively negotiated agreements. This
section also does not prohibit the
employer from paying for costs
associated with testing required by
paragraph (g)(1) of this section.
Otherwise, the agency leaves the
decision regarding who pays for the
testing to the employer. Because OSHA
does not specify who pays for the
testing, OSHA expects that some
workers and/or their representatives
will negotiate the terms of payment.
OSHA has also considered that some
employers may choose to pay for some
or all of the costs of testing as an
inducement to keep employees in a tight
labor market. Other employers may
choose to put the full cost of testing on
employees in recognition of the
employee’s decision not to become fully
vaccinated. It is also possible that some
employers may be required to cover the
cost of testing for employees pursuant to
other laws or regulations. OSHA notes,
for instance, that in certain
circumstances, the employer may be
required, under the Fair Labor
Standards Act, to pay for the time it
takes an employee to be tested (e.g., if
employee testing is conducted in the
middle of a work shift). The subject of
payment for the costs associated with
testing pursuant to other laws or
regulations not associated with the OSH
Act is beyond OSHA’s authority and
jurisdiction. As explained in a note to
paragraph (d) of this ETS, under various
anti-discrimination laws, workers who
cannot be tested because of a sincerely
held religious belief may ask for a
reasonable accommodation from their
employer. For more information about
evaluating requests for reasonable
accommodation for a sincerely held
religious belief, employers should
consult the Equal Employment
Opportunity Commission’s website:
https://www.eeoc.gov/wysk/what-you-
should-know-about-covid-19-and-ada-
rehabilitation-act-and-other-eeo-laws.
Pursuant to paragraph (g)(2), if an
employee does not provide the result of
a COVID–19 test as required by
paragraph (g)(1), the employer must
keep the employee removed from the
workplace until the employee provides
a test result. This provision is
imperative because workers with
asymptomatic or pre-symptomatic
SARS–CoV–2 infection are significant
contributors to COVID–19 transmission,
and screening testing will help to
identify and remove those individuals
from the workplace. Employees
providing accurate and weekly test
results to their employer is of utmost
importance for preventing and reducing
the transmission of COVID–19 in the
workplace.
Paragraph (g)(3) provides that when
an employee has received a positive
COVID–19 test, or has been diagnosed
with COVID–19 by a licensed healthcare
provider, the employer must not require
that employee to undergo COVID–19
testing for 90 days following the date of
their positive test or diagnosis. This
provision is specifically intended to
prohibit screening testing for 90 days
because of the high likelihood of false
positive results that do not indicate
active infection but are rather a
reflection of past infection. Studies of
patients who were hospitalized and
recovered indicate that SARS–CoV–2
RNA can be detected in upper
respiratory tract specimens for up to
three months (90 days) after symptom
onset (CDC, August 2, 2021; CDC,
September 14, 2021). If employees were
to be subjected to screening tests in such
a situation it would both undermine the
confidence in the COVID–19 screening
tests and could result in a harm to the
worker of being unnecessarily removed
from the workplace and subjected to the
additional burden of unnecessary tests.
Where employers implement a
vaccination policy that allows
employees to choose to provide proof of
regular testing and wear a face covering
rather than getting vaccinated, the
employer’s policy and procedures to
implement this temporary suspension of
testing must be included in their written
workplace policy as required by
paragraph (d)(2) of this ETS.
Paragraph (g)(4) provides that the
employer must maintain a record of
each test result required to be provided
by each employee under paragraph
(g)(1) of this ETS or obtained during
tests conducted by the employer. These
records must be maintained in
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accordance with 29 CFR 1910.1020 as
an employee medical record and must
not be disclosed except as required by
this ETS or other federal law. However,
these records are not subject to the
retention requirements of 29 CFR
1910.1020(d)(1)(i) (Employee medical
records), but must be maintained and
preserved while this ETS remains in
effect.
Additionally, paragraph (l) of this ETS
includes specific timeframes for
providing access to records, including
the COVID–19 test results required by
paragraph (g)(1). As a result, the
timeframes for providing access to
employee medical records in 29 CFR
1910.1020(e) do not apply. Instead,
when providing access to an employee,
anyone with written authorized consent
from that employee, and OSHA,
employers must follow the access
timeframes set forth in paragraph (l) of
this ETS. The Summary and
Explanation for paragraph (l) (Section
VI.L. of this preamble) contains
additional information about accessing
records gathered pursuant to paragraph
(g)(1).
Finally, while the access timeframes
in 29 CFR 1910.1020(e) and retention
requirements of 29 CFR
1910.1020(d)(1)(i) do not apply to test
result records required by this ETS, the
other provisions in 29 CFR 1910.1020
do apply. For example, 29 CFR
1910.1020(h) includes requirements for
the transfer of employee medical
records when an employer ceases to do
business. Like the vaccine records
required by paragraph (e)(4) of this ETS,
and because they concern the health
status of an employee, test result records
required by paragraph (g)(1) are
employee medical records for purposes
of 29 CFR 1910.1020. These test result
records contain personally identifiable
medical information and must be
maintained in a confidential manner.
The Summary and Explanation for
paragraph (e) (Section VI.E. of this
preamble) contains additional
information about the interplay between
this ETS and OSHA’s regulation at 29
CFR 1910.1020.
References
Bender et al., (2021, February 18). Analysis
of Asymptomatic and Presymptomatic
Transmission in SARS–CoV–2 Outbreak,
Germany, 2020. https://wwwnc.cdc.gov/
eid/article/27/4/20-4576_article. (Bender
et al., February 18, 2021).
Byambasuren O et al. (2020, December 11).
Estimating the extent of asymptomatic
COVID–19 and its potential for
community transmission: Systematic
review and meta-analysis. Official
Journal of the Association of Medical
Microbiology and Infectious Disease
Canada. 5(4): 223–234 doi:10.3138/
jammi-2020–0030. (Byambasuren et al.,
December 11, 2020).
Centers for Disease Control and Prevention
(CDC). (2020, December 4). Information
for Clinicians on Investigational
Therapeutics for Patients with COVID–
19. https://www.cdc.gov/coronavirus/
2019-ncov/hcp/therapeutic-options.html.
(CDC, December 4, 2020).
Centers for Disease Control and Prevention
(CDC). (2021, May 4). Antigen Testing for
Screening in Non-Healthcare
Workplaces: A tool to prevent the spread
of COVID–19. https://www.cdc.gov/
coronavirus/2019-ncov/community/
workplaces-businesses/antigen-
testing.html. (CDC, May 4, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, June 30). Interim Guidance
for Use of Pooling Procedures in SARS–
CoV–2 Diagnostic and Screening Testing.
https://www.cdc.gov/coronavirus/2019-
ncov/lab/pooling-procedures.html. (CDC,
June 30, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, August 2). COVID–19
Testing Overview. https://www.cdc.gov/
coronavirus/2019-ncov/symptoms-
testing/testing.html. (CDC, August 2,
2021).
Centers for Disease Control and Prevention
(CDC). (2021, September 10). Using
Antibody Tests for COVID–19. https://
www.cdc.gov/coronavirus/2019-ncov/
lab/resources/antibody-tests.html. (CDC,
September 10, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, September 14). Ending
Isolation and Precautions for People with
COVID–19: Interim Guidance. https://
www.cdc.gov/coronavirus/2019-ncov/
hcp/duration-isolation.html. (CDC,
September 14, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, September 15). Science
Brief: COVID–19 Vaccines and
Vaccination. https://www.cdc.gov/
coronavirus/2019-ncov/science/science-
briefs/fully-vaccinated-people.html.
(CDC, September 15, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, October 7) Interim
Guidance for SARS–CoV–2 Testing in
Non-Healthcare Workplaces. https://
www.cdc.gov/coronavirus/2019-ncov/
community/organizations/testing-non-
healthcare-workplaces.html. (CDC,
October 7, 2021).
Food and Drug Administration (FDA). (2020,
August 24). Pooled Sample Testing and
Screening Testing for COVID–19. https://
www.fda.gov/medical-devices/
coronavirus-covid-19-and-medical-
devices/pooled-sample-testing-and-
screening-testing-covid-19. (FDA, August
24, 2020).
Food and Drug Administration (FDA). (2021,
May 19). Antibody Testing Is Not
Currently Recommended to Assess
Immunity After COVID–19 Vaccination:
FDA Safety Communication. https://
www.fda.gov/medical-devices/safety-
communications/antibody-testing-not-
currently-recommended-assess-
immunity-after-covid-19-vaccination-
fda-safety. (FDA, May 19, 2021).
Food and Drug Administration (FDA). (2021,
October 6). In Vitro Diagnostics EUAs.
https://www.fda.gov/medical-devices/
coronavirus-disease-2019-covid-19-
emergency-use-authorizations-medical-
devices/in-vitro-diagnostics-euas. (FDA,
October 6, 2021).
Griffin JB et al. (2021, August 27). SARS–
CoV–2 infections and hospitalizations
among persons aged ≥16 years, by
vaccination status—Los Angeles County,
California, May 1–July 25, 2021. MMWR
70: 1170–1176. http://dx.doi.org/
10.15585/mmwr.mm7034e5. (Griffin et
al., August 27, 2021).
Johansson MA et al. (2021, January 7). SARS–
CoV–2 transmission from people without
COVID–19 symptoms. JAMA Network
Open. 4(1): e2035057. doi:10.1001/
jamanetworkopen.2020.35057.
(Johansson et al., January 7, 2021).
Klompas M et al., (2021, September). The
case for mandating COVID–19 vaccines
for health care workers. Annals of
Internal Medicine. https://doi.org/
10.7326/M21-2366. (Klompas et al.,
September 2021).
Larremore DB et al. (2021, January 1). Test
sensitivity is secondary to frequency and
turnaround time for COVID–19
screening. Sci Adv 2021; 7(1): eabd5393.
https://doi.org/10.1126/sciadv.abd5393.
(Larremore, January 1, 2021).
Lopez Bernal et al. (2021, July 21).
Effectiveness of COVID–19 vaccines
against the B.1.617.2 (Delta) variant. The
New England Journal of Medicine,
385(7), 585–594. https://doi.org/10.1056/
NEJMoa2108891. (Lopez Bernal, July 21,
2021).
National Institutes of Health (NIH). (2021,
September 24). Therapeutic Management
of Nonhospitalized Adults With COVID–
19. https://www.covid19treatmentguide
lines.nih.gov/management/clinical-
management/nonhospitalized-adults--
therapeutic-management/. (NIH,
September 24, 2021).
Nishiura H et al. (2020, March 4). Serial
interval of novel coronavirus (COVID–
19) infections. Int J Infect Dis. 2020 Apr;
93: 284–286. doi:10.1016/
j.ijid.2020.02.060. Epub 2020 Mar 4.
PMID: 32145466; PMCID: PMC7128842.
(Nishiura et al., March 4, 2020).
Sah P et al. (2021, August 10). Asymptomatic
SARS–COV–2 infection: A systematic
review and meta-analysis. Proceedings of
the National Academy of Sciences,
118(34), 1–12. https://doi.org/10.1073/
pnas.2109229118. (Sah et al., August 10,
2021).
Schulte P et al. (2021, May 19). Proposed
Framework for Considering SARS–CoV–
2 Antigen Testing of Unexposed
Asymptomatic Workers in Selected
Workplaces. J Occup Environ Med. 2021
Aug; 63(8): 646–656. Published online
2021, May 19. https://www.ncbi
.nlm.nih.gov/pmc/articles/PMC8327768/
. (Schulte et al., May 19, 2021).
Smith R et al. (2021, September 15).
Longitudinal assessment of diagnostic
test performance over the course of acute
SARS–CoV–2 infection. The Journal of
Infectious Diseases; 224(6), 976–982.
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https://doi.org/10.1093/infdis/jiab337.
(Smith et al., September 15, 2021).
Tindale LC et al. (2020, June 22). Evidence
for transmission of COVID–19 prior to
symptom onset. Elife. 2020; 9: e57149.
Published 2020 Jun 22. doi:10.7554/
eLife.57149. (Tindale et al., June 22,
2020).
H. Employee Notification to Employer of
a Positive COVID–19 Test and Removal
Employers can substantially reduce
disease transmission in the workplace
by removing employees who are
confirmed to have COVID–19 based on
a COVID–19 test or diagnosis by a
healthcare provider. It is necessary that
employees who are confirmed to have
COVID–19 be removed from the
workplace to prevent transmission to
other employees. Several studies have
focused on the impact of isolating
persons with COVID–19 from others
during their likely known infectious
period, and those studies show that
isolation is a strategy that reduces the
transmission of infections. For example,
Kucharski et al. (2020) found that
transmission of SARS–CoV–2 would
decrease by 29% with self-isolation
within the household, which would
extend to 37% if the entire household
quarantined. Similarly, Wells et al.
(2021) found that isolation of
individuals at symptom onset would
decrease the reproductive rate (R0) of
COVID–19 from 2.5 to 1.6. Lastly,
Moghadas et al. (2020) reported results
that highlight the role of silent
transmission, from a combination of the
pre-symptomatic stage and
asymptomatic infections, as the primary
driver of COVID–19 outbreaks and
underscore the need for mitigation
strategies, including those that detect
and isolate infectious individuals prior
to the onset of symptoms. Isolating
contagious employees from their co-
workers can prevent further spread at
the workplace and safeguard the health
of other employees.
Paragraph (h) provides that employers
must require each employee to promptly
notify the employer when the employee
receives a positive COVID–19 test or is
diagnosed with COVID–19 by a licensed
healthcare provider. This notification
must occur regardless of employee
vaccination status. As discussed in
Grave Danger (Section III.A. of this
preamble), exposure to SARS–CoV–2 in
the workplace presents a grave danger to
employees; removing those who are
confirmed to have COVID–19 from the
workplace mitigates that grave danger.
This is true even for fully vaccinated
employees since they also have the
potential to transmit COVID–19 to other
individuals, including other employees.
Because the goal of this ETS, and the
notification requirements in this
paragraph, is to reduce transmission of
COVID–19 in the workplace, employees
are required to notify the employer of
any COVID–19 positive test or diagnosis
that they receive, not just positive
results that are received from testing
required under paragraph (g) of this
ETS.
Paragraph (h)(1) states that the
employer must require each employee
who is COVID–19 positive to notify the
employer of their COVID–19 test result
or diagnosis ‘‘promptly.’’ For employees
who are not at the workplace when they
receive a positive COVID–19 test result
or diagnosis, ‘‘promptly’’ notifying the
employer means notifying the employer
as soon as practicable before the
employee is scheduled to start their
shift or return to work. In the event that
the employee is in the workplace when
they receive a positive COVID–19 test
result or diagnosis of COVID–19,
‘‘promptly’’ notifying the employer
means notifying the employer as soon as
safely possible while avoiding exposing
any other individuals in the workplace.
The employer should establish
notification procedures and inform
employees about these procedures (see
paragraph (j)(1)), so that employees are
aware of the appropriate method for
providing this notification to their
employer. These notification procedures
can be based on the employer’s current
protocols for employees to notify the
employer if they are not able to come to
work or need to leave work because of
illness or injury. However the employer
chooses to implement its notification
procedures, it must ensure that an
employee notification of a positive
COVID–19 test or diagnoses results in
the employee’s immediate removal from
the workplace, as required under
paragraph (h)(2). For example, the
employer may require employees to
report any positive COVID–19 test or
diagnosis to a company supervisor with
the authority to temporarily remove the
employee from the workplace. If an
employer takes all steps required under
this paragraph but an employee fails to
report required information, the ETS
does not dictate that any disciplinary
action be taken against the employee. If
an employer is cited by OSHA under
this provision under such
circumstances, the employer is entitled
to contest the citation if it can establish
an employee misconduct defense in
accordance with applicable case law.
The notification requirement in
paragraph (h)(1) is an important
measure to ensure employers can take
adequate steps to protect their
employees from the hazard of COVID–
19 because it is connected to a parallel
requirement in paragraph (h)(2) to
remove, from the workplace, any
employee who receives a positive
COVID–19 test or is diagnosed with
COVID–19. It is important to remove
employees who test positive or are
diagnosed with COVID–19 from the
workplace as soon as possible to prevent
the transmission of COVID–19 to other
employees. Therefore, the requirement
that employees promptly inform their
employer of a positive COVID–19 test
result or COVID–19 diagnosis is
necessary because this information
allows the employer to take actions to
protect other employees, including most
critically by removing employees whose
illness poses a direct threat of infection
to other employees in the workplace.
Paragraph (h)(2) requires employers to
immediately remove from the workplace
any employee, regardless of vaccination
status, who receives a positive COVID–
19 test or is diagnosed with COVID–19
by a licensed healthcare provider.
OSHA determined that directing an
employee who tests positive or is
diagnosed with COVID–19 to stay home
until return to work criteria are
achieved is critical to preventing the
transmission of COVID–19 in the
workplace. Similar to the notification
required in paragraph (h)(1), this
removal must occur regardless of
employee vaccination status since
someone who is fully vaccinated can
still transmit COVID–19 to others,
including other employees (see Grave
Danger, Section III.A. of this preamble).
OSHA notes that, in most
circumstances, any positive COVID–19
test would result in removal. However,
this is not necessarily the case where an
employer uses pooled COVID–19
testing, a method where one laboratory
test is conducted using the specimens of
several people to detect the virus that
causes COVID–19 (CDC, June 30, 2021).
If an employer conducts pooled testing
for COVID–19, a positive pooled test
result would trigger a need to
immediately re-test those employees in
the pool using an individual COVID–19
test because the positive pooled result
would not satisfy the requirements of
paragraph (g). Only those employees
who test positive on their individual re-
test would need to be removed from the
workplace.
OSHA intends ‘‘removal’’ under
paragraph (h)(2) to refer only to the
temporary removal from the workplace
of an employee while that employee is
infectious. The requirement in
paragraph (h)(2) to temporarily remove
a COVID–19 positive employee from the
workplace does not mean permanent
removal of an employee from their
position. Any time an employee is
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required to be removed from the
workplace under paragraph (h)(2) of this
section, the employer can require the
employee to work remotely or in
isolation if suitable work is available
and if the employee is not too ill to
work. In cases where working remotely
or in isolation is not possible, OSHA
encourages employers to consider
flexible and creative solutions, such as
a temporary reassignment to a different
position that can be performed by
telework. However, if an employee is
too ill to work, remote work should not
be required, and sick leave or other
leave should be made available as
consistent with the employer’s general
policies and practices, and as may be
required under applicable laws.
After an employee has been removed
from the workplace as required by
paragraph (h)(2), the employer must
ensure that they do not return to the
workplace until the employee meets one
of three criteria outlined in paragraphs
(h)(2)(i) through (h)(2)(iii). The purpose
of these provisions is to ensure that an
employee who has COVID–19 does not
return to work until the risk that they
will transmit the disease to others in the
workplace has been minimized. Each of
these provisions is based on the best
scientific evidence available on when a
person with COVID–19 is no longer
likely to transmit the virus.
Under paragraph (h)(2)(i), the
employee can return to work if they
receive a negative result on a COVID–19
nucleic acid amplification test (NAAT)
following a positive result on a COVID–
19 antigen test (the most common
screening test). There is a small
possibility for employees to receive false
positive test results when conducting
regular screening with an antigen test.
Positive results are usually highly
accurate at moderate-to-high peak viral
load, but false positives can occur,
depending on the course of infection
(FDA, April 2021). OSHA recognizes
that an employee might choose to seek
a NAAT test for confirmatory testing.
NAATs are considered the ‘‘gold
standard’’ for clinical diagnosis of
SARS–CoV–2 and may have a higher
sensitivity (i.e., ability to correctly
generate a positive result) than antigen
tests (CDC, September 9, 2021). If an
employee tested positive for COVID–19
via an antigen test, but then received
follow-up confirmatory testing via a
NAAT and the NAAT was negative, the
positive antigen test can be considered
a false positive and the employee can
return to work (CDC, September 9,
2021). For a more detailed discussion of
COVID–19 tests, see the Summary and
Explanation for paragraph (c) (Section
VI.C. of this preamble).
The employee may also return to
work if they meet the return to work
criteria in CDC’s ‘‘Isolation Guidance’’
(incorporated by reference, § 1910.509)
(CDC, February 18, 2021) as described
in paragraph (h)(2)(ii). CDC’s guidance
states that a COVID–19 positive person
can stop isolating when three criteria
are met: (1) At least ten days have
passed since the first appearance of the
person’s symptoms; (2) the person has
gone at least 24 hours without a fever
(without the use of fever-reducing
medication); and (3) the person’s other
symptoms of COVID–19 are improving
(excluding loss of taste and smell). If a
person has tested positive but never
experiences symptoms, then the person
can stop isolating after ten days from the
date of their positive test. These
recommendations are based on
scientific evidence reviewed by CDC,
which indicates that levels of viral RNA
in upper respiratory tract samples begin
decreasing after the onset of symptoms
(CDC, September 14, 2021). The
rationale for including CDC’s ‘‘Isolation
Guidance’’ in the ETS was addressed in
detail in Need for Specific Provisions in
the agency’s prior rulemaking on
1910.502 (see 86 FR 32376, 32455).
Finally, the employee may return to
work, per paragraph (h)(2)(iii), if the
employee receives a return-to-work
recommendation from a licensed
healthcare provider. The appropriate
duration of removal from work for any
given individual may differ depending
on factors such as disease severity or the
health of the employee’s immune
system. For this reason, the ETS permits
employers to make decisions about an
employee’s return to work in
accordance with guidance from a
licensed healthcare provider (who
would be better acquainted with a
particular employee’s condition). If a
licensed healthcare provider
recommends a longer period of isolation
for a particular employee than the CDC’s
‘‘Isolation Guidance’’ would otherwise
recommend, then the employer would
need to abide by that longer period
rather than returning the employee to
work after ten days.
OSHA’s removal requirements as
outlined in paragraph (h)(2) are
intended to set the floor for what is
required; however, OSHA encourages
employers who are able to do so to have
a more robust program of medical
removal, as indeed some employers
have already done. In addition to
removal from the workplace based on a
positive COVID–19 test or diagnosis of
COVID–19, employers may consider
removal based on COVID–19 symptoms
or certain exposure or close contacts
employees have had outside of the
workplace. Similarly, employers may
consider removing employees from the
workplace if the employer learns that
the employee was notified by a state or
local public health authority to
quarantine or isolate; the employer
might even be contacted by such an
authority directly. Although this ETS
does not require removal from the
workplace in those situations, the
employer might choose to remove
employees from the workplace, above
and beyond what is required by this
ETS.
Finally, the note to paragraph (h)(2)
clarifies that this ETS does not require
employers to provide paid time to any
employee for removal as a result of a
positive COVID–19 test or diagnosis of
COVID–19; however, paid time may be
required by other laws, regulations, or
collective bargaining agreements or
other collectively negotiated
agreements. On the other hand, the ETS
does not preclude employers from
choosing to pay employees for time
required for removal under this
standard. Additionally, employers
should allow their employees to make
use of any accrued leave in accordance
with the employer’s policies and
practices on use of leave. This
provision, while not placing the burden
on the employer to provide paid time,
should not be read as depriving
employees of the benefits they are
normally entitled to as part of their
employment.
Because it does not require employers
to provide paid time to employees who
are removed for a positive COVID–19
test or diagnosis of COVID–19, this ETS
differs from OSHA’s COVID–19
Healthcare ETS, which applies to
employees in the healthcare industry
who are expected to be exposed to
COVID–19, and requires paid medical
removal protection benefits
(§ 1910.502(l)(5)) for most employees.
This difference reflects the structure and
focus of this ETS relative to the
Healthcare ETS. The Healthcare ETS
requires employees to report symptoms
of COVID–19 to their employers, as well
as positive COVID–19 tests or diagnoses
(see § 1910.502(l)(2)), but does not
require employees to be regularly tested
for COVID–19. A primary function of
the payment for medical removal in that
standard is, therefore, to remove the
potential for financial disincentives that
might deter employees from reporting
any signs or symptoms of COVID–19
that they experience. Because this ETS
already requires testing for
unvaccinated workers, which should
result in employers learning of cases of
COVID–19 in unvaccinated workers,
and does not otherwise require
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employees to report signs and
symptoms of COVID–19 to their
employers, OSHA found that requiring
employer payment for removal was not
necessary in this standard.
As the note to paragraph (h) indicates,
the employer may be required to follow
other laws or regulations that would
require paid medical removal. For
example, if an employee covered by this
ETS believes they were exposed to
COVID–19 in the workplace and then
tested positive, that employee may be
entitled to workers’ compensation
benefits. Workers’ compensation is a
system already in place to provide
benefits to employees who get sick or
injured on the job from occupational
disease or a work-related injury. Some
states have expressly clarified or
expanded their workers compensation
rules to allow for COVID–19 claims
during the pandemic (see, e.g.,
Industrial Commission of Arizona, May
15, 2020; Connecticut Executive Order
No. 7JJJ, July 24, 2020; Minn. Stat. Ann.
§ 176.011 Subd. (15)(f), 2020)).
Finally, the ETS does not contain
specific requirements under this
paragraph for the employer to establish
or maintain records of employee
notifications of a positive COVID–19
test or diagnosis of COVID–19 by a
licensed healthcare provider. However,
should an employer determine that a
reported case of COVID–19 is work-
related, the employer must continue to
record that information on the OSHA
Forms 300, 300A, and 301, or on
equivalent forms, if required to do so
under 29 CFR part 1904. This also
includes confirmed cases of COVID–19
identified under paragraph (h) that an
employer determines are work-related.
Under 29 CFR part 1904, COVID–19 is
a recordable illness and employers are
responsible for recording cases of
COVID–19 if: (1) The case is a
confirmed case of COVID–19 as defined
by the Centers for Disease Control and
Prevention (CDC); (2) the case is work-
related as defined by 29 CFR part
1904.5; and (3) the case involves one or
more of the general recording criteria in
set forth in 29 CFR part 1904.7 (e.g.,
medical treatment beyond first aid, days
away from work). Under 29 CFR part
1904, employers must generally provide
access to the 300 log to employees,
former employees, and their
representatives with the names of
injured or ill employees included on the
form. If, however, the employee requests
that their name not be entered on the
300 log, the employer must treat their
illness as a privacy concern case and
may not enter their name on the log (see
29 CFR 1904.29(b)(6), (b)(7)(vi)).
References
Centers for Disease Control and Prevention
(CDC). (2021, February 18). Isolate if you
are sick. https://www.cdc.gov/
coronavirus/2019-ncov/if-you-are-sick/
isolation.html. (CDC, February 18, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, June 30). Interim Guidance
for Use of Pooling Procedures in SARS-
CoV–2 Diagnostic and Screening Testing.
https://www.cdc.gov/coronavirus/2019-
ncov/lab/pooling-procedures.html. (CDC,
June 30, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, September 9). Interim
Guidance for Antigen Testing for SARS-
CoV–2. https://www.cdc.gov/
coronavirus/2019-ncov/lab/resources/
antigen-tests-guidelines.html. (CDC,
September 9, 2021).
Centers for Disease Control and Prevention
(CDC). (2021, September 14). Ending
Isolation and Precautions for People with
COVID–19: Interim Guidance. https://
www.cdc.gov/coronavirus/2019-ncov/
hcp/duration-isolation.html. (CDC,
September 14, 2021).
Connecticut Executive Order No. 7JJJ. (2020,
July 24). Executive Order No. 7JJJ
Protection of public health and safety
during COVID–19 pandemic and
response—rebuttable presumption
regarding workers compensation benefits
related to contraction of COVID–19.
https://portal.ct.gov/-/media/Office-of-
the-Governor/Executive-Orders/Lamont-
Executive-Orders/Executive-Order-No-
7JJJ.pdf. (Connecticut Executive Order
No. 7JJJ, July 24, 2020).
Food and Drug Administration (FDA). (2021,
April). Coronavirus Disease 2019 Testing
Basics. https://www.fda.gov/media/
140161/download. (FDA, April 2021).
Industrial Commission of Arizona. (2020,
May 15). COVID–19 Workers’
Compensation Claims. https://
www.azica.gov/sites/default/files/
SPS%20-COVID-19%20FINAL.pdf.
(Industrial Commission of Arizona, May
15, 2020).
Kucharski AJ et al. (2020). Effectiveness of
isolation, testing, contact tracing, and
physical distancing on reducing
transmission of SARS–CoV–2 in
different settings: a mathematical
modelling study. The Lancet Infectious
Disease. 2020 Oct; 20(10): 1151–1160.
doi:10.1016/S1473–3099(20)30457–6.
Epub 2020 Jun 16. PMID: 32559451;
PMCID: PMC7511527. (Kucharski et al.,
2020)
Minnesota Statutes Annotated, Section
176.011 Definitions. Subd. 15(f). (2020).
https://www.revisor.mn.gov/statutes/
cite/176.011/pdf. (Minn. Stat. Ann.
§ 176.011 Subd. (15)(f), 2020)
Moghadas S et al. (2020, July 6). The
implications of silent transmission for
the control of COVID–19 outbreaks.
Proceedings of the National Academy of
Sciences of the United States of America,
117(30), 17513–17515. doi:https://
doi.org/10.1073/pnas.2008373117.
(Moghadas et al., July 6, 2020)
Wells CR et al. (2021). Optimal COVID–19
quarantine and testing strategies. Nature
Communications 2021 Jan 7; 12(1): 356.
doi:10.1038/s41467–020–20742–8.
PMID: 33414470; PMCID: PMC7788536.
(Wells et al., 2021)
I. Face Coverings
Paragraph (i) of this standard
addresses the use of face coverings. As
previously discussed in Grave Danger
(Section III.A. of this preamble),
COVID–19 spreads when an infected
person breathes out droplets and very
small particles that contain the virus.
These droplets and particles can be
breathed in by other people or land on
their eyes, noses, or mouth. Face
coverings reduce the risk of droplet
transmission of COVID–19. The CDC
recommends that people who are not
fully vaccinated wear a face covering
(e.g., a mask) in indoor public places.
(CDC, July 14, 2021). Additional
discussion on the efficacy of face
coverings is provided below.
Face coverings are simple bi-
directional barriers that tend to keep
droplets, and to a lesser extent airborne
particulates, on the side of the filter
from which they originate. An
explanation of the term ‘‘face covering’’,
as used in this ETS, can be found in the
Summary and Explanation for
paragraph (c) (Section VI.C. of this
preamble). The CDC (August 13, 2021)
recommends unvaccinated people wear
face coverings when indoors to prevent
getting and spreading COVID–19 mostly
by blocking large respiratory droplets
from either leaving the face covering of
the wearer (source control) or by
preventing someone else’s droplets from
reaching the wearer (personal
protection). The need for face coverings
in workplaces applies particularly to
unvaccinated workers due to their
increased potential for asymptomatic
and pre-symptomatic transmission of
COVID–19.
The CDC Healthcare Infection Control
Practices Advisory Committee’s
(HICPAC) ‘‘Isolation Guidance’’ for
healthcare settings has long
recommended facemasks, among other
controls, to prevent the transmission of
viruses that cause respiratory illnesses
(Siegel et al., 2007). Face coverings play
an important dual role in protecting
workers from droplet transmission of
COVID–19. One of their key purposes is
to function as source control. In this
role, the face covering helps protect
people around the wearer by reducing
the number of infectious droplets
released into the air by the wearer and
limiting the distance traveled by any
particles that are released. As a result,
anyone near the wearer is exposed to
fewer (if any) droplets and the
transmission risk is lowered (OSHA,
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January 28, 2021; Siegel et al., 2007).
Face coverings also provide a degree of
particulate filtration to reduce the
amount of inhaled particulate matter,
meaning face coverings can help protect
the wearer themselves, by reducing their
inhalation of droplets produced by an
infected person nearby (CDC, May 7,
2021; Brooks et al., February 10, 2021).
The efficacy of any given face
covering in either functioning as source
control or protecting the wearer will
depend on the construction, design, and
material used for the face covering. The
CDC has stated that ‘‘masks are
primarily intended to reduce the
emission of virus-laden droplets
(‘‘source control’’), which is especially
relevant for asymptomatic or
presymptomatic infected wearers who
feel well and may be unaware of their
infectiousness to others, and who are
estimated to account for more than 50%
of transmissions’’ (CDC, May 7, 2021).
The CDC has also stated that: ‘‘Multi-
layer cloth masks block release of
exhaled respiratory particles into the
environment, along with the
microorganisms these particles carry.
Cloth masks not only effectively block
most large droplets (i.e., 20–30 microns
and larger) but they can also block the
exhalation of fine droplets and particles
(also often referred to as aerosols)
smaller than 10 microns; which increase
in number with the volume of speech
and specific types of phonation. Multi-
layer cloth masks can both block up to
50–70% of these fine droplets and
particles and limit the forward spread of
those that are not captured. Upwards of
80% blockage has been achieved in
human experiments that have measured
blocking of all respiratory droplets, with
cloth masks in some studies performing
on par with surgical masks as barriers
for source control’’ (CDC, May 7, 2021).
Thus, the construction of the face
covering is a significant factor in
determining its efficacy at reducing
COVID–19 transmission.
While face coverings are generally
effective as source control, because of
the potential variations in protective
properties, OSHA has not considered
face coverings that are not certified to a
consensus standard to be personal
protective equipment (PPE) under
OSHA’s general PPE standard (29 CFR
1910.132), as there is insufficient
assurance that any given face covering
is of safe design and construction for the
work to be performed, which is required
by the PPE standard. Despite these
limitations, many of the available face
coverings have proven to be effective at
providing source control, and where a
face covering is also effective in
providing personal protection, the
wearer will be at reduced risk of, and
could be protected from, infection.
Accordingly, over the course of the
pandemic, through its guidance, OSHA
has strongly encouraged workers to
wear face coverings when they are in
close contact with others to reduce the
risk of spreading COVID–19 despite the
shortcomings that have prevented the
agency from considering them to be PPE
that complies with the requirement of
the PPE standard. To enhance the
effectiveness of any face covering
required by this standard, this ETS
imposes certain minimum design
criteria, consistent with CDC
recommendations. Thus, the face
covering must consist of at least two
layers of material that is either tightly
woven or non-woven, and the face
covering must not have visible holes or
openings. CDC has found face coverings
that are tightly woven and made with at
least two layers are more effective at
filtering droplets than face coverings
that are loosely woven or consist of a
single layer of fabric (CDC, May 7, 2021;
Ueki et al., June 25, 2020).
OSHA’s determination on the
importance of face coverings is
supported by a substantial body of
evidence. As described in further detail
below, consistent and correct use of face
coverings is widely recognized and
scientifically supported as an important
evidence-based strategy for COVID–19
control. Accordingly, with specific
exceptions relevant to outdoor areas and
vaccinated persons, the CDC
recommends everyone two years of age
and older wear a face covering in public
settings and when around people
outside of their household (CDC, August
13, 2021). And, on January 21, 2021,
President Biden issued Executive Order
13998, which recognizes the use of face
coverings or facemasks as a necessary,
science-based public health measure to
prevent the spread of COVID–19, and
therefore directed regulatory action to
require that they be worn in compliance
with CDC guidance while traveling on
public transportation (e.g., buses, trains,
subway) and while at airports
(Executive Order 13998, 86 FR 7205,
7205 (Jan. 21, 2021); CDC, February 2,
2021). Similarly, the World Health
Organization (WHO) has recognized face
coverings as a key measure in
suppressing COVID–19 transmission,
and thus, saving lives. The WHO
observes that face coverings serve two
purposes, to both protect healthy people
from acquiring COVID–19 and to
prevent sick people from further
spreading it. Since December of 2020,
the WHO has recommended that the
general public wear face coverings in
indoor settings and in outdoor settings
where physical distancing cannot be
maintained (WHO, December 1, 2020).
In the United States, several states
have imposed statewide face covering
mandates in order to mitigate the spread
of COVID–19. One study examined data
on statewide face covering mandates
during March 1–October 22, 2020, and
found that statewide face covering
mandates were associated with a
decline in weekly COVID–19–associated
hospitalization growth rates by up to 5.6
percentage points for adults aged 18–64
years after mandate implementation,
compared with growth rates during the
4 weeks preceding implementation of
the mandate (Joo et al., February 12,
2021). Similarly, another study
examined the association of state-issued
face covering mandates with COVID–19
cases and deaths during March 1–
December 31, 2020, and found
mandating face coverings was
associated with a decrease in daily
COVID–19 case and death growth rates
within 20 days of implementation (Guy
et al., March 12, 2021).
School face covering policies for
students, staff members, faculty, and
visitors are associated with a reduction
in COVID–19 outbreaks. Between July
15 and August 31, 2021, schools in
Arizona were analyzed for school mask
policies, which provided that all
persons, regardless of vaccination
status, were required to wear a mask
indoors. The odds of a school-associated
COVID–19 outbreak in schools without
a mask requirement were 3.5 times
higher than those in schools with an
early mask requirement (Odds Ratio =
3.5; 95% Confidence Interval = 1.8–6.9)
(Jehn et al., October 1, 2021).
The effectiveness of face coverings in
limiting the emission and spread of
droplets has also been demonstrated in
numerous studies. For example,
multiple studies in which droplets were
visualized while individuals were
talking or a manikin was used to
simulate coughs and sneezes
demonstrated that two-layer face
coverings limited the number of
droplets released into the air, and
limited the forward spread of those not
captured (Fischer et al., September 2,
2020; Verma et al., June 30, 2020; CDC,
May 7, 2021).
The effectiveness of face coverings in
preventing infections was also observed
in a number of epidemiological studies.
For example, in June of 2020 an
outbreak was studied aboard the USS
Theodore Roosevelt, an environment
notable for congregate living quarters,
close working environments, and a
sample of mostly young, healthy adults.
The investigation found that use of face
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coverings on board was associated with
a 70% reduced risk of transmission,
which demonstrates that the use of face
coverings, especially among
asymptomatic cases, can help mitigate
future transmission (Payne et al., June
12, 2020). Another publication, released
in July of 2020, included an
investigation of a high-exposure event
among 139 clients exposed to two
symptomatic hair stylists with
confirmed cases of COVID–19. Both of
the stylists and all of their clients wore
face coverings during their interactions.
Among 67 clients subsequently tested
for COVID–19, all test results were
negative; no symptomatic secondary
cases were reported by any clients,
including those who were not tested.
The study concluded that the strict use
of face coverings likely mitigated the
spread of COVID–19 (Hendrix et al.,
July 17, 2020).
Several other observational
epidemiological studies have reviewed
data regarding the ‘‘real-world’’
effectiveness of face covering usage.
First, in a study of 124 Beijing
households with one or more
laboratory-confirmed case of COVID–19,
face covering use by both the index
patient and all family contacts before
the index patient developed symptoms
reduced secondary transmission (i.e.,
infections occurring within two weeks
of symptom onset in the index case)
within the households by 79% (Wang et
al., May 11, 2020). Second, a
retrospective case-control study from
Thailand documented that, among more
than 1,000 persons interviewed as part
of contact tracing investigations, those
who reported having always worn a face
covering during high-risk exposures
experienced a greater than 70% reduced
risk of infection compared with persons
who did not wear face coverings under
these circumstances. The risk for
infection was not significantly lower in
those who reported only sometimes
wearing face coverings compared to
those who did not wear face coverings
at all. This evidence supports the
conclusion that face coverings must be
worn consistently and correctly to
meaningfully reduce the risk of
infection (Doung-ngern et al., September
14, 2020).
Community-level analyses have also
confirmed the benefit of universal face
covering use in: A unified hospital
system (Wang et al., July 14, 2020); a
German city (Mitze et al., June 1, 2020);
a U.S. state (Gallaway et al., October 6,
2020); a panel of 15 U.S. states and
Washington, DC (Lyu and Wehby, June
16, 2020; Hatzius et al., June 29, 2020);
as well as both Canada (Karaivanov et
al., October 1, 2020) and the U.S.
(Chernozhukov et al., September 15,
2020) nationally. Each community
analysis demonstrated that, following
universal face covering directives from
both organizational and political
leadership, new infections were shown
to fall significantly. These analyses have
also shown reductions in mortality and
the need for lockdowns, with their
associated monetary/gross domestic
product losses (Leffler et al., December
2, 2020; Hatzius et al., June 29, 2020).
Additionally, multiple investigations
involving infected passengers aboard
flights longer than ten hours strongly
suggest that face covering usage
prevented in-flight transmissions, as
demonstrated by the absence of
infection developing in other passengers
and crew in the 14 days following
exposure (Schwartz et al., April 14,
2020; Freedman and Wilder-Smith,
September 25, 2020).
Researchers from the COVID–19
Systematic Urgent Review Group Effort
investigated the effects of face coverings
and eye protection on virus
transmission in both healthcare and
non-healthcare settings. They identified
172 observational studies for their
systematic review and 44 comparative
studies for their meta-analysis,
including data on 25,697 COVID–19,
SARS, or MERS patients. They
concluded for the general public, based
mainly on evidence from face covering
use within households and among
contacts of cases, that disposable
surgical masks or face coverings
(reusable multi-layer cotton face
coverings) are associated with
protection from viral transmission.
Through the meta-analysis, combining
39 of the studies’ results, they found a
14.3% reduction in the difference of
anticipated absolute effect (e.g., the
chance of viral infection or
transmission) between no face covering
and face covering groups (Chu et al.,
June 27, 2020).
Ueki et al. (June 25, 2020) evaluated
the effectiveness of cotton face
coverings, facemasks, and N95s (a
commonly used respirator) in
preventing transmission of SARS–CoV–
2 using a laboratory experimental
setting with manikins. The researchers
found that all offerings provided some
measure of protection as source control,
limiting droplets expelled from both
infected and uninfected wearers. For
instance, when spaced roughly 20
inches apart, an uninfected person can
reduce inhalation of infectious virus by
37% by wearing a cotton face covering.
If only the infected person wears a
cotton face covering, the amount
breathed in by the uninfected recipient
is reduced by 57%. However, if both
individuals wear a cotton face covering,
the exposure is reduced 67%. If both are
wearing facemasks, exposure is reduced
by 76%. When an infected individual
wore an N95 respirator, exposure was
reduced by 96% or, when the seams
were taped, 99.7%.
As demonstrated by the studies above,
proper face covering usage leads to a
substantial reduction in the emission of
virus-containing droplets and
consequent transmission of the virus.
This is especially critical for
asymptomatic or pre-symptomatic
infected wearers who feel well and may
not be taking other preventative
measures—like self-isolation—because
they are unaware of their infectiousness
to others. Combined, these individuals
are estimated to account for more than
50% of COVID–19 transmissions
(Honein et al., December 11, 2020;
Moghadas et al., July 6, 2020; Johansson
et al., January 7, 2021). This figure could
be substantially reduced if face
coverings are required, even for
individuals who do not feel sick. Face
covering use is also especially important
in indoor spaces (Honein et al.,
December 11, 2020). The studies
reviewed above show that face
coverings reduce the release of droplets
but do not completely eliminate them.
CDC guidance affirms that COVID–19
pandemic control requires face covering
use (Honein et al., December 11, 2020;
CDC, May 7, 2021). Similarly, the WHO
advises face covering use as a critical
measure of a comprehensive package of
prevention and control measures to
limit the spread of COVID–19 (WHO,
December 1, 2020).
Although increasing COVID–19
vaccination coverage remains the most
effective means to achieve control of the
pandemic, additional layered
prevention strategies will be needed in
the short term to minimize preventable
morbidity and mortality among
unvaccinated individuals. Unvaccinated
individuals remain at substantial risk
for infection, severe illness, and death,
especially in areas where the level of
SARS–CoV–2 community transmission
is high (discussed in detail in Grave
Danger (Section III.A. of this preamble)).
Among strategies to prevent COVID–19,
CDC recommends all unvaccinated
individuals wear face coverings in
public indoor settings. A proven
effective strategy against SARS–CoV–2
transmission, beyond vaccination,
includes using face coverings
consistently and correctly (Christie et
al., July 30, 2021).
The agency is not requiring the use of
face coverings by workers who are fully
vaccinated because vaccination is
sufficient to reduce the grave danger to
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themselves or others. While vaccination
is sufficient to reduce grave danger to
the workers themselves, the agency
recognizes that there may still be
residual risk (e.g., breakthrough
infections); severe health outcomes
among vaccinated workers, however, are
unlikely. Vaccination is also sufficient
to reduce the grave danger that fully
vaccinated workers present to others
given the reduced likelihood of
transmission (see Grave Danger in
Section III.A. of this preamble).
Nonetheless, the use of face coverings
by fully vaccinated workers, while not
required by this ETS, is strongly
encouraged in a wide range of
circumstances to reduce the overall risk
of transmitting COVID–19, particularly
in areas of substantial or high
transmission, when indoors and when
in crowded outdoor areas. The use of
face coverings by customers and visitors
to workplaces is also beneficial in
reducing the overall risk of workplace
transmission of COVID–19.
OSHA has always considered
recognized consensus standards, with
design and construction specifications,
when determining the PPE requirements
of the agency’s standards. The OSH Act
(29 U.S.C. 655(b)(8)) requires the agency
to generally give deference to consensus
standards unless setting its own
specifications would better effectuate
the purposes of the Act. The agency’s
standards generally require PPE to
conform to the specifications in
consensus standards through
incorporation by reference (e.g., eye and
face protection, head protection, foot
protection). ASTM released a
specification standard on February 15,
2021, to establish a national standard
baseline for barrier face coverings
(ASTM F3502–21). OSHA considered,
as required, incorporation of ASTM
F3502–21 in this ETS. However, the
agency has determined that it is
infeasible for the timeframe of this ETS
to incorporate this consensus standard
or to otherwise establish additional
criteria for face coverings beyond that
already recommended by the CDC due
to the time needed to manufacture and
distribute any new product. OSHA
notes the CDC’s guidance on types of
masks, including those that meet ASTM
F3502–21 requirements, and respirators
as helpful to employers and workers in
selecting an appropriate product (CDC,
September 23, 2021).
Relatedly, OSHA has previously
established that medical facemasks are
essential PPE for workers in healthcare
and associated industries, and are
already used by workers under both the
general PPE standard (29 CFR
1910.132), and more specifically, the
Bloodborne Pathogens standard (29 CFR
1910.1030). Facemasks are intended for
a medical purpose, such as prevention
of infectious disease transmission
(including uses related to COVID–19).
Facemasks can function as a barrier to
protect the wearer from hazards such as
splashes or large droplets of blood and
bodily fluids. Facemasks, such as
surgical masks, must be FDA-cleared or
authorized by FDA, including under an
EUA and provide a similar or greater
level of protection when serving the
purposes of a face covering. Respirators
are another type of personal protective
device that OSHA has regulated under
the Respiratory Protection standard (29
CFR 1910.134).
The best available experimental and
epidemiological data support consistent
use of face coverings by unvaccinated
workers in work settings to reduce the
spread of COVID–19 through droplet
transmission. As discussed in Need for
the ETS (Section III.B. of this preamble),
adopting face covering policies is
necessary, as part of a strategy combined
with testing, to protect employees from
exposure to COVID–19. Requiring
unvaccinated workers to wear face
coverings in the workplace will reduce
the likelihood that, in conjunction with
the testing (paragraph (g)) and removal,
of infected workers, (paragraph (h))
requirements, they will spread the virus
to others, including other unvaccinated
coworkers. Based on the proven
effectiveness of face covering use,
OSHA’s COVID–19 ETS includes
necessary provisions for required use of
face coverings by unvaccinated workers
and provisions to allow vaccinated
workers and customers and visitors to
wear face coverings or respirators as a
component of reducing the overall risk
of COVID–19 transmission in the
workplace.
The benefits that result from the use
of face coverings for preventing
transmission of COVID–19 are derived
from the combination of source control
(i.e., reducing the spread of large
respiratory droplets to others by
covering an infected person’s mouth
and nose) and some personal protection
for the wearer, as was discussed above
in the Need for Face Coverings section.
Face coverings are a vital layer of
protection, and the benefit to any given
individual increases with increasing
community use. Paragraph (i) contains
requirements for the use of face
coverings by each employee who is not
fully vaccinated, as well as alternatives
to face coverings (e.g., facemasks,
respirators) that may be acceptable in
some situations (described in detail
below). As defined in paragraph (c), a
face covering means a covering that
completely covers the nose and mouth
of the wearer, excluding face shields,
which is made with two or more layers
of a breathable fabric that is tightly
woven, is secured to the wearer’s head
with ties, ear loops, or elastic bands that
go behind the head, and is a solid piece
of material without slits, exhalation
valves, visible holes, or other openings
in the material. This definition
encompasses face coverings that
otherwise meet the definition of face
covering under paragraph (c), but
include clear plastic windows, such as
those utilized by persons
communicating with those who are deaf
or hard-of-hearing or when seeing a
person’s mouth is otherwise important.
Face coverings can be manufactured or
homemade, and they can incorporate a
variety of designs, structures, and
materials. Face coverings can be
disposable or reusable. Face coverings
do not have to meet a consensus
standard, although they might. Apart
from any applicable FDA or NIOSH
regulatory requirements that might
otherwise apply, such requirements are
not required solely for the purposes of
meeting the requirements of this
standard.
As a general rule, OSHA has authority
to, and does, require employers to bear
the costs for protective equipment,
among other worker protections,
required by an OSHA standard. See,
e.g., 29 CFR 1910.1018(j) (requiring the
employer to provide protective clothing
at no cost to the employee). However, in
limited circumstances, OSHA has
chosen not to require employers to pay
for some forms of non-specialized
protective equipment, such as every-day
clothing, products providing weather-
related protection, and non-specialized
equipment that the employee wears off
the job site. See 29 CFR 1910.132(h)(2)–
(5). Like the analogous situations listed
above, here employees may use their
personal face coverings in a variety of
circumstances on and off the job site as
part of their every-day protection.
Because the types of face coverings
permitted under this ETS are widely
used and readily available, (see
Technological Feasibility (Section IV.A.
of this preamble)), employees will have
no difficulty obtaining them. OSHA is
requiring employers to bear the costs for
employee vaccination, because it is the
more protective control, (Need for the
ETS (Section III.B. of this preamble).
OSHA does not believe it appropriate to
impose the costs of personal face
coverings on an employer where an
employee has made an individual
choice to pursue a less protective
option. For these reasons, OSHA has
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determined not to impose the costs of
face coverings on the employer as a
requirement under this ETS.
Paragraph (i)(1) requires employers to
ensure that each employee who is not
fully vaccinated wears a face covering
when indoors or when occupying a
vehicle with another person for work
purposes, except (i) when an employee
is alone in a room with floor to ceilings
windows and a closed door. However, if
that employee exits the room or another
individual enters the room, they are
required to wear a face covering. The
second exception is (ii) for a limited
time while an employee is eating or
drinking at the workplace or for
identification purposes in compliance
with safety and security requirements.
Under this exception, employees are not
required to wear face coverings during
the limited time while eating or
drinking at the workplace. Employers
may also let employees eat or drink
outside where there may be more space
and reduced risk of transmission.
Additionally, under the exception in
paragraph (i)(1)(ii), employees are not
required to wear a face covering for a
limited time for identification purposes
in compliance with safety and security
requirements. This means that an
unvaccinated employee can temporarily
remove their face covering when at a
security checkpoint within their
worksite and when identification is
otherwise required.
Another exception for required face
coverings is under paragraph (i)(1)(iii)
for when an employee is wearing a
respirator or facemask in accordance
with other OSHA standards (e.g.,
1910.134, 1910.504, 1910.1030,
1910.502). Facemask or respirator use in
accordance with other OSHA standards
takes precedence over face covering use
in this ETS. For example, OSHA
standard 1910.1030 has requirements
for facemasks in healthcare settings and
requires that workers should continue to
use the required facemask appropriate
for that setting. Another example may
include a worker who is required to use
a respirator under 1910.134 for
workplace exposure to harmful dusts,
where effective engineering controls are
not feasible; that worker should
continue to use the required respirator.
Employees must resume wearing a face
covering when not engaged in the
activity where a facemask or respirator
is required as an essential part of their
job. The last exception, contained in
paragraph (i)(1)(iv), is for a very limited
set of circumstances where employers
can show that the use of the face
covering is infeasible or creates a greater
hazard. Situations where it is important
to see an employee’s mouth for reasons
related to their job duties, or their job
requires the use of their uncovered
mouth, or when the use of a face
covering presents a risk of serious injury
or death to the employee, would also be
covered under this provision. As has
been previously discussed in Summary
and Explanation for paragraph (d)
(Section VI.D. of this preamble), OSHA
recognizes that there may be certain
workers who may not be able to wear a
face covering due to a disability or
sincerely held religious belief and are
entitled to an accommodation.
If employers receive accommodation
requests relating to face coverings or
other protective gear, for example due to
disability or religious garb or grooming,
they should evaluate those requests
under applicable laws (EEOC, October
25, 2021).
Paragraph (i)(2) requires that
employers ensure that any face covering
required to be worn by this section is:
(i) Worn by the employee to fully cover
the employee’s nose and mouth; and (ii)
replaced when wet, soiled, or damaged
(e.g., is ripped, has holes, or has broken
ear loops). To be worn properly, face
coverings must completely cover the
wearer’s mouth and nose and must fit
snugly against the sides of the face
without gaps. Gaps can let air with
respiratory droplets leak in and out
around the edges of the mask. Face
coverings with a nose wire help to avoid
issues with glasses fogging and create a
snug fit. Workers can also use a mask
fitter or brace over a disposable mask or
a cloth mask to prevent air from leaking
around the edges of the mask. To ensure
face coverings are worn properly, an
employer might appoint a manager or
senior employee to check that each
unvaccinated employee is properly
wearing a face covering at the start of
and throughout each shift. Many aspects
of proper mask use are easily observable
(e.g., covering the mouth and nose, as
well as no observable gaps).
Additionally, employers may consider
utilizing workplace announcements
(email messages, safety talks, etc.) or
displaying signs or posters throughout
the facility about proper face covering
usage.
The employer must ensure that
employees replace face coverings when
wet, soiled, or damaged (paragraph
(i)(2)(ii)). Face coverings can become
soiled by splashes, sprays, or splatters,
from contact with a contaminated
surface, or by touching/adjusting them
with contaminated hands. Damaged face
coverings may not fit properly and thus
will have reduced effectiveness.
Employees who work where there is
potential for spills, sprays, or splashes
may need to change or replace their face
coverings more frequently (e.g., in food,
meat, or poultry processing plants;
water, sanitation, or wastewater
treatment facilities; or restaurants). As
note 1 to paragraph (i) addresses, face
shields may be worn in addition to face
coverings to prevent them from getting
wet and soiled. For work where face
coverings are expected to become dirty
or soiled less frequently, employees may
only need to replace their face coverings
daily (e.g., in retail or office buildings).
Regardless of work location, reusable
face coverings can become soiled after
each use and may be contaminated with
bacteria and viruses, including the virus
that causes COVID–19. To ensure
performance and minimize the risk of
contaminating employees after contact
with a soiled face covering, as described
previously, the CDC recommends
washing them whenever they get dirty,
but at least once a day. The CDC also
has guidance on the selection, proper
wearing, cleaning, and storage of face
coverings (CDC, August 13, 2021).
The employer must not prevent any
employee, regardless of vaccination
status, from voluntarily wearing a face
covering or facemask unless the
employer can demonstrate that doing so
would create a hazard (paragraph (i)(3)).
While vaccination greatly reduces the
risk of the most severe consequences of
COVID–19 (e.g. hospitalizations and
fatalities) to workers, it does not reduce
the risk to zero and thus workers must
be permitted to wear face coverings or
facemasks even when not required to in
order to allow the workers to further
address residual risk. The agency has
determined this provision is necessary
because employees may themselves
have additional medical risk factors that
employers may or may not be aware of,
and which require enhanced
precautions. Similarly, employees may
live with or have frequent contact with
family members or others who have
enhanced risk if infected with COVID–
19 and thus justify assuring the
employees’ ability to take reasonable
precautions to protect their own health
and safety or that of loved ones.
Paragraph (i)(4) states that the
employer must permit the employee to
wear a respirator instead of a face
covering whether required or not (i.e.,
without regard to vaccination status),
and the employer may provide
respirators to the employee, even if not
required. This means that when a face
covering is not required by paragraph
(i)(1), the employer must permit the
employee to wear a respirator or the
employer may even provide a respirator;
in such circumstances, the employer
must also comply with 1910.504 (the
mini respiratory protection program).
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Respirators, as defined in paragraph (c),
are a type of PPE that are certified by
NIOSH or authorized under an
Emergency Use Authorization (EUA) by
the FDA, and protect against airborne
hazards by removing specific air
contaminants from the ambient
(surrounding) air or by supplying
breathable air from a safe source.
Respirator use can provide an additional
level of comfort and protection beyond
that provided by face coverings for
employees in circumstances that do not
require a respirator to be used. As
discussed previously, the agency has
determined that workers need the
ability to wear PPE, even when it is not
required, in order to address residual
risk and due to health conditions that
either they or their close contacts may
have that warrant enhanced
precautions. For a more in-depth
description of the mini respiratory
protection program, see the preamble to
the Healthcare ETS (86 FR 32615–
32617). OSHA intends the mini
respirator protection program to be
preserved for the duration of this ETS,
and any references relied upon by
OSHA in those sections of the
Healthcare ETS are also incorporated
explicitly into the rulemaking docket for
this ETS.
The mini respiratory protection
program is designed to strengthen
employee protections with a small set of
provisions for the safe use of respirators
designed to be easier and faster to
implement than the more
comprehensive respiratory protection
program under 29 CFR 1910.134. This
ETS is addressing an emergency health
crisis, so it is critical for employers to
be able to get more employee protection
in place quickly. OSHA expects that this
approach will facilitate additional
employee choice for the additional
protection provided by respirators while
reducing disincentives that may have
discouraged employers from allowing or
voluntarily providing respirators. A
mini respirator program is therefore an
important control to protect employees
from the hazard posed by COVID–19.
The mini respiratory protection
program is primarily intended to be
used for addressing circumstances
where employees are not exposed to
suspected or confirmed sources of
COVID–19, but where respirator use
could offer enhanced protection to
employees. Examples include when a
respirator could offer enhanced
protection in circumstances where a less
protective (in terms of filtering and fit)
face covering is required under the ETS
(See 29 CFR 1910.501(i)(1)). The
decision to use a respirator in place of
a face covering could be due to the
higher filter efficiency and better sealing
characteristics of respirators when
compared to face coverings. For
additional discussion, the rationale for
the mini respiratory protection program
was addressed in detail in Need for
Specific Provisions in the agency’s prior
rulemaking on 1910.504, and the
requirements of the mini respiratory
protection program section are
discussed in Summary and Explanation
in the agency’s prior rulemaking on
1910.504.
As required by paragraph (i)(5), the
employers must not prohibit customers
or visitors from wearing face coverings.
Face coverings are a vital layer of
protection against the risk of COVID–19.
(See the discussion earlier in this
section on the benefits to individuals
associated with increased community
use.) This provision is necessary
because increased use of face coverings
also reduces the overall risk of COVID–
19 transmission from the customers and
visitors to workers, both unvaccinated
and vaccinated alike. Additionally, it
allows customers and visitors to protect
their own health and safety. Employers
may even want to create a policy
encouraging the use of face coverings by
anyone who enters the business; they
are encouraged to coordinate with state
and local health officials to obtain and
respond appropriately to timely and
accurate information (e.g., level of
community transmission, health system
capacity, vaccination coverage, capacity
for early detection of increases in
COVID–19 cases, and populations at
risk for severe outcomes from COVID–
19). Local conditions will influence the
decisions that public health officials
make regarding community-level
strategies. Additionally, workers and
their representatives may also negotiate
additional face covering measures not
required by the ETS through collective
bargaining agreements or other
collectively negotiated agreements.
Lastly, for the reasons explained
above, note 2 to paragraph (i) clarifies
that this section does not require the
employer to pay for any costs associated
with face coverings. However, the note
also makes clear that this section does
not prohibit the employer from paying
for costs associated with face coverings
required by this section. OSHA notes
that employer payment for face
coverings may be required by other
laws, regulations, or collective
bargaining agreements or other
collectively negotiated agreements.
Additionally, workers and their
representatives may also negotiate
employer payment for face coverings
not required by the ETS through
collective bargaining agreements or
other collectively negotiated
agreements.
References
Brooks J et al. (2021, February 10).
Maximizing fit for cloth and medical
procedure masks to improve
performance and reduce SARS–CoV–2
transmission and exposure. MMWR. doi:
http://dx.doi.org/10.15585/
mmwr.mm7007e1. (Brooks et al.,
February 10, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, February 2). Order under
Section 361 of the Public Health Service
Act (42 U.S.C. 264) and 42 Code of
Federal Regulations 70.2, 71.31(b),
71.32(b). Federal Register notice:
Wearing of face masks while on
conveyances and at transportation hubs.
https://www.cdc.gov/quarantine/masks/
mask-travel-guidance.html. (CDC,
February 2, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, May 7). Scientific brief:
Community Use of Cloth Masks to
Control the Spread of SARS–CoV–2.
https://www.cdc.gov/coronavirus/2019-
ncov/more/masking-science-sars-
cov2.html. (CDC, May 7, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, July 14). How COVID–19
spreads. https://www.cdc.gov/
coronavirus/2019-ncov/prevent-getting-
sick/how-covid-spreads.html. (CDC, July
14, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, August 13). Your Guide to
Masks. https://www.cdc.gov/
coronavirus/2019-ncov/prevent-getting-
sick/about-face-coverings.html. (CDC,
August 13, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, September 23). Types of
Masks and Respirators. https://
www.cdc.gov/coronavirus/2019-ncov/
prevent-getting-sick/types-of-masks.html.
(CDC, September 23, 2021)
Chernozhukov V et al. (2020, September 15).
Causal impact of masks, policies,
behavior on early COVID–19 pandemic
in the U.S. Journal of Econometrics. doi:
https://doi.org/10.1016/
j.jeconom.2020.09.003. (Chernozhukov et
al., September 15, 2020)
Christie A et al. (2021, July 30). Guidance for
implementing COVID–19 prevention
strategies in the context of varying
community transmission levels and
vaccination coverage. MMWR 70: 1044–
1047. http://dx.doi.org/10.15585/
mmwr.mm7030e2. (Christie et at., July
30, 2021).
Chu DK et al. (2020, June 27). Physical
Distancing, Face Masks, and Eye
Protection to Prevent Person-to-Person
Transmission of SARS–CoV–2 and
COVID–19: A systematic review and
meta-analysis. The Lancet. 395: 1973–
1987. https://doi.org/10.1016/. (Chu et
al., June 27, 2020)
Doung-ngern P et al. (2020). Case-control
study of use of personal protective
measures and risk for SARS–CoV–2
infection, Thailand. Emerging Infectious
Diseases, 26(11), 2607–2616. doi: https://
VerDate Sep<11>2014
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61542
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dx.doi.org/10.3201/eid2611.203003.
(Doung-ngern et al., September 14, 2020).
Equal Employment Opportunity Commission
(EEOC). (2021, October 25). What You
Should Know About COVID–19 and the
ADA, the Rehabilitation Act, and Other
EEO Laws. https://www.eeoc.gov/wysk/
what-you-should-know-about-covid-19-
and-ada-rehabilitation-act-and-other-
eeo-laws. (EEOC, October 25, 2021)
Fischer E et al. (2020, September 2). Low-cost
measurement of face mask efficacy for
filtering expelled particles during
speech. Science Advances, 6(36). doi:
https://doi.org/10.1126/sciadv.abd3083.
(Fischer et al., September 2, 2020)
Freedman D and Wilder-Smith A. (2020,
September 25). In-flight transmission of
SARS–CoV–2: A review of the attack
rates and available data on the efficacy
of face masks. Journal of Travel
Medicine. doi: https://doi.org/10.1093/
jtm/taaa178. (Freedman and Wilder-
Smith, September 25, 2020)
Gallaway S et al. (2020, October 6). Trends
in COVID–19 incidence after
implementation of mitigation
measures—Arizona, January 22–August
7, 2020. MMWR, 69, 1460–1463. doi:
http://dx.doi.org/10.15585/
mmwr.mm6940e3. (Gallaway et al.,
October 6, 2020)
Guy GP Jr et al. (2021, March 12). Association
of State-Issued Mask Mandates and
Allowing On-Premises Restaurant Dining
with County-Level COVID–19 Case and
Death Growth Rates—United States,
March 1–December 31, 2020. MMWR
Morb Mortal Wkly Rep 2021; 70: 350–
354. doi: http://dx.doi.org/10.15585/
mmwr.mm7010e3. (Guy et al., March 12,
2021)
Hatzius J et al. (2020, June 29). Face masks
and GDP. Goldman Sachs Research.
https://www.goldmansachs.com/
insights/pages/face-masks-and-gdp.html.
(Hatzius et al., June 29, 2020)
Hendrix J et al. (2020, July 17). Absence of
apparent transmission of SARS–CoV–2
from two stylists after exposure at a hair
salon with a universal face covering
policy—Springfield, Missouri, May 2020.
MMWR, 69, 930–932. doi: http://
dx.doi.org/10.15585/mmwr.mm6928e2.
(Hendrix et al., July 17, 2020)
Honein MA et al. (2020, December 11).
Summary of Guidance for Public Health
Strategies to Address High Levels of
Community Transmission of SARS–
CoV–2 and Related Deaths, December
2020. MMWR Morb Mortal Wkly Rep
2020; 69: 1860–1867. doi: http://
dx.doi.org/10.15585/mmwr.mm6949e2.
(Honein et al., December 11, 2020)
Jehn M et al. (2021, October 1). Association
between K–12 school mask policies and
school-associated COVID–19 outbreaks—
Maricopa and Pima Counties, Arizona,
July–August 2021. MMWR 70: 1372–
1373. http://dx.doi.org/10.15585/
mmwr.mm7039e1. (Jehn et al., October 1,
2021).
Johansson MA et al. (2021, January 7). SARS–
CoV–2 transmission from people without
COVID–19 symptoms. JAMA Network
Open, 4(1), e2035057. https://doi.org/
10.1001/jamanetworkopen.2020.35057.
(Johansson et al., January 7, 2021)
Joo H, Miller GF, Sunshine G, et al. (2021,
February 12). Decline in COVID–19
Hospitalization Growth Rates Associated
with Statewide Mask Mandates—10
States, March–October 2020. MMWR
Morb Mortal Wkly Rep 2021; 70: 212–
216. doi: http://dx.doi.org/10.15585/
mmwr.mm7006e2. (Joo et al., February
12, 2021)
Karaivanov A et al. (2020, October 1). Face
masks, public policies and slowing the
spread of COVID–19: Evidence from
Canada. National Bureau of Economic
Research. http://www.nber.org/papers/
w27891. (Karaivanov et al., October 1,
2020)
Leffler C et al. (2020, December 2).
Association of country-wide Coronavirus
mortality with demographics, testing,
lockdowns, and public wearing of masks.
The American Journal of Tropical
Medicine and Hygiene, 103(6), 2400–
2411. https://doi.org/10.4269/ajtmh.20–
1015. (Leffler et al., December 2, 2020)
Lyu W and Wehby G. (2020, June 16).
Community use of face masks and
COVID–19: Evidence from a natural
experiment of state mandates in the U.S.
Health Affairs, 39(8), 1419–1425. doi:
10.1377/hlthaff.2020.00818. (Lyu and
Wehby, June 16, 2020)
Mitze T et al. (2020, June 1). Face masks
considerably reduce COVID–19 cases in
Germany: A synthetic control method
approach. IZA—Institute of Labor
Economics (Germany). http://ftp.iza.org/
dp13319.pdf. (Mitze et al., June 1, 2020)
Moghadas S et al. (2020, July 6). The
implications of silent transmission for
the control of COVID–19 outbreaks.
Proceedings of the National Academy of
Sciences of the United States of America,
117(30), 17513–17515. doi: https://
doi.org/10.1073/pnas.2008373117.
(Moghadas et al., July 6, 2020)
Occupational Safety and Health
Administration (OSHA). (2021, January
28). Frequently asked questions COVID–
19. https://www.osha.gov/coronavirus/
faqs. (OSHA, January 28, 2021)
Payne D et al. (2020, June 12). SARS–CoV–
2 infections and serologic responses from
a sample of U.S. Navy Service
Members—USS Theodore Roosevelt.
MMWR, 69(23), 714–721. doi: https://
doi.org/10.15585/mmwr.mm6923e4.
(Payne et al., June 12, 2020)
Schwartz K et al. (2020, April 14). Lack of
COVID–19 transmission on an
international flight. Canadian Medical
Association Journal, 192(15), E410. doi:
https://doi.org/10.1503/cmaj.75015.
(Schwartz et al., April 14, 2020)
Siegel J, Rhinehart E, Jackson M, Chiarello L,
and the Healthcare Infection Control
Practices Advisory Committee. (2007).
2007 Guideline for isolation precautions:
Preventing transmission of infectious
agents in healthcare settings. https://
www.cdc.gov/infectioncontrol/pdf/
guidelines/isolation-guidelines-H.pdf.
(Siegel et al., 2007)
Ueki H et al. (2020, October 21). Effectiveness
of Face Masks in Preventing Airborne
Transmission of SARS–CoV–2. mSphere
5: e00637–20. https://doi.org/10.1128/
mSphere.00637-20. (Ueki et al., October
21, 2020)
Verma S et al. (2020, June 30). Visualizing
the effectiveness of face masks in
obstructing respiratory jets. Physics of
Fluids, 32(6), 061708. doi: https://
doi.org/10.1063/5.0016018. (Verma et al.,
June 30, 2020)
Wang X et al. (2020, July 14). Association
between universal masking in a health
care system and SARS–CoV–2 positivity
among health care workers. Journal of
the American Medical Association,
324(7), 703–704. doi: 10.1001/
jama.2020.12897. (Wang et al., July 14,
2020)
Wang Y et al. (2020, May 11). Reduction of
secondary transmission of SAR–CoV–2
in households by face mask use,
disinfection and social distancing: A
cohort study in Beijing, China. BMJ
Global Health, 5, e002794. doi: 10.1136/
bmjgh–2020–002794. (Wang et al., May
11, 2020)
World Health Organization (WHO). (2020,
December 1). Mask use in the context of
COVID–19. https://www.who.int/
emergencies/diseases/novel-coronavirus-
2019/advice-for-public/when-and-how-
to-use-masks. (WHO, December 1, 2020)
J. Information Provided to Employees
In order to successfully implement
the provisions of the ETS, it is critical
that employers provide relevant
information to employees. Employers
must provide employees with the
information specified in paragraph (j),
an essential part of this ETS, because it
helps to ensure that employees
understand both their rights and
responsibilities under the ETS and their
employer’s policies and procedures. The
ETS cannot be effective if employees do
not have sufficient knowledge and
understanding of the requirements of
the ETS, their employers’ policies and
procedures, information about available
COVID–19 vaccines, their protections
against retaliation and discrimination,
and the potential penalties for
knowingly providing false information
to their employer.
Paragraph (j) provides that employers
must provide the required information
to each employee in a language and at
a literacy level the employee
understands. This means that if an
employer has employees that speak
different languages or are at different
literacy levels, the employer must
present information in a way that
ensures each employee can understand
it. This may require an employer to
create different materials for different
groups of employees (e.g., materials in
different languages). When information
must be translated into different
languages, employers must ensure the
translation is one the employees can
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understand. When an employer
provides employees with the required
information in a manner employees
understand, they help ensure that their
implementation of this ETS is
successful.
The manner in which employers
provide the required information to
employees may vary based on the size
and type of workplace. Employers have
flexibility to communicate this
information to employees using any
effective methods that are typically used
in their workplaces, and may choose
any method of informing employees so
long as each employee receives the
information specified in the standard in
a language and at a literacy level they
understand. For example, an employer
may provide this information to
employees through email
communications, printed fact sheets, or
during a discussion at a regularly
scheduled team meeting. To ensure
comprehension of the information
provided, employers can identify a
point-of-contact for employees who
have questions about the information
provided.
Paragraphs (j)(1)–(4) specify the
information that employers must
provide to employees. Paragraph (j)(1)
requires employers to provide each
employee with information regarding
the requirements of § 1910.501 and any
policies and procedures the employer
establishes to implement this ETS. The
information provided to employees
must cover any employer policies under
paragraph (d), including the details of
the employer’s vaccination policy.
Employers must also inform employees
about the process that will be used to
determine employee vaccination status,
as required under paragraph (e). In
addition, employers must inform
employees about the time and pay/leave
they are entitled to for vaccinations and
any side effects experienced following
vaccinations, as required by paragraph
(f). And employers must also inform
employees about the procedures they
need to follow to provide notice of a
positive COVID–19 test or diagnosis of
COVID–19 by a licensed healthcare
provider, as required under paragraph
(h), as well as the procedures to be used
for requesting records under paragraph
(l). Employers must provide additional
information to unvaccinated employees,
including information about the
employer’s policies and procedures for
COVID–19 testing and face coverings, as
required by paragraphs (g) and (i),
respectively.
Some employers may have informed
employees about their COVID-related
workplace-specific policies, e.g.,
policies on vaccination, testing, and face
coverings, prior to the effective date of
this ETS. Employers may rely on any
such prior communications for purposes
of complying with paragraph (j)(1) to the
extent that the prior communications
meet the relevant requirements of
paragraph (j) and there have been no
changes to the relevant policies.
Employers must review and evaluate the
information already provided to
determine whether it covers all of the
information necessary under paragraph
(j)(1). If previous information provided
to employees did not cover all of the
required elements, the employer must
provide employees the information on
those missing elements to come into
compliance with the ETS. For example,
if an employer has a mandatory
vaccination policy and has already
provided information to the employees
on the policies and procedures the
employer has established to implement
that policy, and provided that
information in a language and at a
literacy level each employee can
understand, the employer would not
need to expend resources to provide
that information again to meet the
requirements under this ETS. However,
the employer would still need to
provide information to its employees
about other new policies and
procedures established to implement
the ETS.
When an employer’s policies or
procedures change, the employer must
provide any updated or supplemental
information to employees. For example,
an employer may initially opt to allow
only paper copies as proof of COVID–19
test results. Over time, however, the
employer may decide that it wants to
accept electronic proof of test results. If
that employer modifies its policy to
permit employees to submit electronic
proof of test results, the employer must
inform employees of any new or altered
policies and procedures that the
employer implements as a result.
Paragraph (j)(2) requires employers to
provide information to each employee
about COVID–19 vaccine efficacy,
safety, and the benefits of being
vaccinated. To meet this requirement,
employers must provide the CDC’s
document, ‘‘Key Things to Know About
COVID–19 Vaccines,’’ available at
https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/keythingstoknow.html
(CDC, October 7, 2021), to each
employee. The employer may choose to
provide this information to employees
in either an electronic or print format.
The CDC currently provides this
document in multiple languages;
however, employers may need to
provide additional translations if
necessary to inform each employee of
the contents of the document in a
language they understand. Employers
do not have any further obligations to
create or provide information on
vaccine efficacy, safety, or the benefits
of being vaccinated beyond providing
the aforementioned CDC document to
each employee.
Paragraph (j)(3) requires employers to
inform each employee about the
requirements of 29 CFR
1904.35(b)(1)(iv) and section 11(c) of the
OSH Act. These two provisions work
together to protect employees from
retaliation for engaging in activities
protected by OSHA statute or
regulation. The first of these provisions,
section 1904.35(b)(1)(iv), prohibits
employers from discharging or in any
manner discriminating against any
employee for reporting a work-related
injury or illness. The second provision,
section 11(c) of the OSH Act, prohibits
employers from discriminating against
employees for exercising rights under,
or as a result of actions required by, the
ETS. Section 11(c) also protects
employees from retaliation for filing an
occupational safety or health complaint,
reporting a work-related injury or
illness, or otherwise exercising any
rights afforded by the OSH Act.
Retaliation takes many forms; it
occurs when an employer (through a
manager, supervisor, or administrator)
fires an employee or takes any other
type of adverse employment action
against an employee for engaging in a
protected activity. Adverse employment
actions include discipline, reducing pay
or hours, reassignment to a less
desirable position, denying overtime or
promotion, intimidation or harassment,
and any other action that would
dissuade a reasonable employee from
raising a concern about a possible
violation or engaging in other protected
activity (see Burlington Northern &
Santa Fe Railway Co. v. White, 548 U.S.
53, 57 (2006) holding, in the Title VII
context, that the test for determining
whether a particular employment action
is materially adverse is whether it
‘‘could well dissuade’’ a reasonable
person from engaging in protected
activity).
The ETS does not change employers’
substantive obligations under either 29
CFR 1904.35(b)(1)(iv) or section 11(c) of
the OSH Act. Rather, it simply requires
employers to make employees aware of
these provisions and their requirements.
By increasing awareness, OSHA
believes that paragraph (j)(3) will
prevent acts of retaliation from
occurring in the workplace, encourage
employees to exercise their right to the
protections of the ETS, and engage
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employees in actions required by the
ETS.
It is critically important for employees
to be aware of, and to be able to
exercise, their rights under the ETS.
Employee participation is essential to
mitigating the spread of COVID–19 in
the workplace, and fear of retaliation
would undermine the effectiveness of
the ETS. For example, per paragraph (f)
of this ETS, employers must provide
employees up to 4 hours of paid time at
the employee’s regular rate of pay for
each vaccination dose, as well as
reasonable time and paid sick leave for
employees to recover from side effects
experienced following any vaccination
dose. If an employer fails to comply
with paragraph (f) and then retaliates
against employees who object,
employees may be deterred from being
vaccinated. Similarly, if employees fear
retaliation, they will be less likely to
voice concerns about unvaccinated co-
workers who do not wear required face
coverings (see paragraph (i)(1)). A
workplace free from the threat of
retaliation promotes collaboration
between employers and employees and
allows employers to more effectively
implement the various requirements of
this ETS.
OSHA has received a record number
of complaints of retaliation during the
COVID–19 pandemic. The agency’s
website shows that, as of September 26,
2021, OSHA had received 5,788
complaints of retaliation related to
workplace protections from COVID–19
(OSHA, September 29, 2021). These
figures indicate that some employers
need to be reminded that they are
legally prohibited from engaging in
retaliatory actions. Additionally,
employees likely need reassurance of
their legal right to engage in protected
activity without fear of suffering from
adverse employment actions. As such, it
is critical for employers to inform
employees of the prohibitions against
retaliation in 29 CFR 1904.35(b)(1)(iv)
and section 11(c) after the effective date
of the ETS, without regard to any
information they may have provided
previously on these anti-retaliation
provisions. As with the other parts of
paragraph (j), employers have flexibility
regarding how they will provide the
required information.
Paragraph (j)(4) requires employers to
provide each employee with
information regarding the prohibitions
of 18 U.S.C. 1001 and Section 17(g) of
the OSH Act, which provide for
criminal penalties associated with
knowingly supplying false statements or
documentation. The first of these two
provisions, 18 U.S.C. 1001(a) is
described earlier in this preamble and
provides for fines or imprisonment for
persons who ‘‘knowingly and willfully’’
(1) falsifies, conceals, or covers up by
any trick, scheme, or device a material
fact; (2) makes any materially false,
fictitious, or fraudulent statement or
representation; or (3) makes or uses any
false writing or document knowing the
same to contain any materially false,
fictitious, or fraudulent statement or
entry. And section 17(g) of the OSH Act
provides for fines up to $10,000, and
imprisonment for not more than six
months, or both, for anyone who
‘‘knowingly makes any false statement,
representation, or certification’’ in any
application, record, report, plan, or
other document ‘‘filed or required to be
maintained pursuant to this chapter.’’
False statements or documents made or
submitted for purposes of complying
with policies required by this ETS could
fall under either or both of these
statutory provisions.
This ETS requires that each employee
provide their employer either COVID–
19 vaccination documentation
(paragraph (e)), or, if applicable, regular
COVID–19 test results (paragraph (g)).
There is a significant public health
interest in ensuring employees provide
this information truthfully to the
employer. Employers cannot effectively
implement the requirements of this ETS
based on false information. By
increasing awareness of the possible
penalties an employee may face for
misrepresenting their vaccination status
or test results, OSHA intends to
discourage such behavior. Employers
can satisfy the requirement of paragraph
(j)(4) by providing each employee with
the text of the two statutory provisions
in hard copy or via electronic
communication (e.g., email), translated
as necessary into other languages,
emphasizing the importance of
providing truthful information about
vaccine status and test results, and
explaining that providing false
information could be punishable under
the two provisions. Employers are not
required to provide further explanation
of the statutory provisions or to provide
legal advice.
Information requirements are routine
components of OSHA standards. The
inclusion of information requirements
in this ETS reflects the agency’s
conviction, as noted above, that
informed employees are essential to the
implementation of any effective
occupational safety and health policy or
procedure. OSHA believes that
informing employees about their rights
and responsibilities under the ETS; the
employer’s policies and procedures; and
the safety, efficacy, and benefits of
vaccination will help increase the
number of employees vaccinated and
will facilitate effective implementation
of the standard by employers.
References
Centers for Disease Control and Prevention
(CDC). (2021, October 7). Key Things to
Know About COVID–19 Vaccines.
https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/keythingstoknow.html.
(CDC, October 7, 2021).
Occupational Safety and Health
Administration (OSHA). (2021,
September 29). COVID–19 Response
Summary: Summary Data for Federal
Programs—Whistleblower Data. https://
www.whistleblowers.gov/covid-19-data.
(OSHA, September 29, 2021).
K. Reporting COVID–19 Fatalities and
Hospitalizations to OSHA
OSHA has required employers to
report work-related fatalities and certain
work-related hospitalizations under its
recordkeeping regulation since 1971.
These requirements have been an
important part of the agency’s statutory
mission to assure safe and healthful
working conditions for all working
people. All employers covered by the
OSH Act, including employers who are
partially exempt from maintaining
injury and illness records, are required
to comply with OSHA reporting
requirements at 29 CFR 1904.39. Under
OSHA’s current reporting regulation,
employers are required to report each
work-related fatality to OSHA within 8
hours of the event, and each work-
related in-patient hospitalization,
amputation, and loss of an eye within
24 hours of the event.
The purpose of the reporting
requirement in § 1904.39 is to provide
OSHA with information to determine
whether it is necessary for the agency to
conduct an immediate investigation at a
specific establishment. Employer
reports of work-related COVID–19
fatalities and in-patient hospitalizations
are an important element of the agency’s
efforts to reduce occupational exposure
to the virus. After receiving an employer
report, OSHA decides whether an
inspection is needed to determine the
cause of a work-related COVID–19
fatality or in-patient hospitalization, and
whether any OSHA standards may have
been violated. These reports are critical
for the agency to respond quickly to
COVID–19 exposure that may pose an
ongoing risk to other employees at the
worksite. Timely investigation also
allows OSHA to view evidence at a
workplace soon after a work-related
COVID–19 fatality or in-patient
hospitalization has occurred, and can
make it easier for the agency to gather
relevant information from others at the
worksite that might be useful in
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protecting other employees. Moreover,
prompt inspection enables OSHA to
gather information to evaluate whether
its current standards adequately address
the workplace hazard presented from
COVID–19. The information gathered
from employer reports is also used by
the agency to form the basis of statistical
data on the causes and remediation of
work-related COVID–19 fatalities and
in-patient hospitalizations.
In order to address the unique
circumstances presented by COVID–19,
and to facilitate OSHA investigation and
better workplace health surveillance,
paragraph (k)(1) requires covered
employers to report each work-related
COVID–19 fatality to OSHA within 8
hours of the employer learning about
the fatality, and each work-related
COVID–19 in-patient hospitalization to
OSHA within 24 hours of the employer
learning about the in-patient
hospitalization. As described in more
detail in the following discussion,
OSHA is adding these additional
COVID–19 reporting requirements
because the delay in the manifestation
and progression of symptoms of
COVID–19 can lead to hospitalization or
fatality outside the normal window for
reporting those workplace events.
Paragraph (k)(1)(i) provides that
employers must report each work-
related COVID–19 fatality to OSHA
within 8 hours of the employer learning
about the fatality. Under this paragraph,
an employer must make a report to
OSHA within 8 hours of learning both
(1) that an employee has died from a
confirmed case of COVID–19, and (2)
that the cause of death was the result of
a work-related exposure to COVID–19.
Employers are only required to report
confirmed cases of COVID–19 as
defined by the Centers for Disease
Control and Prevention (CDC) (CDC,
May 20, 2020). Typically, the cause of
death is determined by the physician
who was responsible for a patient who
died in a hospital, although the cause of
death can also be determined by others
such as medical examiners or coroners
(Pappas, May 19, 2020).
The requirement in paragraph (k)(1)(i)
is similar to the fatality reporting
requirement in OSHA’s regulation at 29
CFR 1904.39(a)(1), which requires an
employer to report to OSHA within 8
hours after the death of any employee as
the result of a work-related incident.
However, 29 CFR 1904.39(b)(6) requires
employers to report a work-related
fatality to OSHA only if the fatality
occurs within 30 days of ‘‘the work-
related incident.’’ Prior to this ETS, for
purposes of reporting events involving
COVID–19, OSHA interpreted the
phrase ‘‘the work-related incident’’ to
mean ‘‘exposure’’ in the work
environment. Therefore, in order to be
reportable under 29 CFR 1904.39(a)(1),
a work-related fatality due to COVID–19
needed to have occurred within 30 days
of an employee’s exposure in the work
environment. Given the possibility of
long-term illness before death, the 30-
day limitation for reporting fatalities to
OSHA could restrict OSHA’s ability to
receive information about work-related
COVID–19 fatalities.
To address these issues, OSHA has
chosen not to apply the 30-day
limitation period from 29 CFR
1904.39(b)(6) to the reporting provision
in paragraph (k) (see paragraph (k)(2)).
Therefore, the requirement to report
these fatalities is not limited by the
length of time between workplace
exposure and death. The reporting of
work-related COVID–19 fatalities that
occur beyond 30 days from the time of
exposure will enable the agency to
evaluate more work-related COVID–19
fatalities to determine whether
immediate investigations are needed to
prevent other employees at the same
worksite from being exposed to the
virus. The report of these fatalities to
OSHA facilitates the agency’s timely
tracking of this data. Accordingly,
paragraph (k)(1)(i) requires employers to
report each work-related COVID–19
fatality to OSHA within 8 hours of the
employer learning about the fatality
regardless of when the exposure in the
work environment occurred.
Paragraph (k)(1)(ii) of the standard
requires an employer to report each
work-related COVID–19 in-patient
hospitalization to OSHA within 24
hours of the employer learning about
the in-patient hospitalization. Under
this paragraph, and similar to OSHA’s
reporting regulation at 29 CFR 1904.39,
an employer must make a report to
OSHA within 24 hours of learning that
(1) an employee has been in-patient
hospitalized due to a confirmed case of
COVID–19, and (2) the reason for the
hospitalization was the result of a work-
related exposure to the illness.
OSHA’s current reporting regulation
at 29 CFR 1904.39(a)(2) provides that,
within 24 hours after the in-patient
hospitalization of one or more
employees, as the result of a work-
related incident, an employer must
report the in-patient hospitalization to
OSHA. 29 CFR 1904.39(b)(6) requires
employers to only report in-patient
hospitalizations to OSHA if the
hospitalization occurs within 24 hours
of the work-related incident. For
example, if an employee trips in the
workplace and sustains an injury on
Monday, but is not hospitalized until
Thursday, the employer does not need
to report the event. In this example, ‘‘the
work-related incident’’ occurred on
Monday when the employee tripped
and was injured in the workplace. Also,
under § 1904.39, employers must report
in-patient hospitalizations to OSHA
within 24 hours of knowing both that
the employee has been in-patient
hospitalized and that the reason for the
hospitalization was the result of ‘‘the
work-related incident’’ (see 29 CFR
1904.39(a)(2), (b)(7)–(b)(8)). In non-
COVID cases, the work-relatedness of
the injury is typically apparent
immediately.
Since the beginning of the pandemic,
the reporting of work-related COVID–19
in-patient hospitalizations under 29
CFR 1904.39 has presented unique
challenges. As noted above, for
purposes of reporting COVID–19
fatalities and in-patient hospitalizations,
OSHA has interpreted the phrase ‘‘the
work-related incident’’ in 29 CFR
1904.39(b)(6) to mean an employee’s
‘‘exposure’’ to COVID–19 in the work
environment. Thus, in order to be
reportable, an in-patient hospitalization
needed to occur within 24 hours of an
employee’s exposure to COVID–19 in
the work environment. Given the
incubation period of the virus, and the
typical timeframe between exposure and
the emergence of symptoms serious
enough to require hospitalization, it is
extremely unlikely for an in-patient
hospitalization to occur within 24 hours
of an employee’s exposure to the virus.
To address these issues, paragraph
(k)(1)(ii) does not limit the COVID–19
reporting requirement to only those
hospitalizations that occur within 24
hours of exposure, as in 29 CFR
1904.39(b)(6). This change in the
reporting requirement will result in
OSHA making more determinations as
to whether immediate investigations are
needed at additional worksites. Given
the severity of the disease, and how
quickly it can spread, it is essential that
remediation efforts at a workplace be
undertaken immediately. As noted
above, it is critical for OSHA to respond
quickly to hazardous conditions where
employees have been hospitalized. The
elimination of the 24-hour limitation
period will not only allow OSHA to
receive more employer reports about
work-related COVID–19 in-patient
hospitalizations and, as a result, shed
light on where severe COVID–19 events
are occurring, but it will also enable the
agency to respond more quickly and
effectively to these situations.
Accordingly, employers must report
each work-related COVID–19 in-patient
hospitalization to OSHA regardless of
when the employee’s exposure in the
workplace occurred (paragraph
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(k)(1)(ii)). But consistent with OSHA’s
normal reporting requirements, when
hospitalization for a work-related case
of COVID–19 does occur, the employer
must report it within 24 hours of
learning about the hospitalization.
Additionally, for purposes of this
section, OSHA defines in-patient
hospitalization as a formal admission to
the in-patient services of a hospital or
clinic for care or treatment (see 29 CFR
1904.39(b)(9) and (b)(10)). The
determination as to whether an
employee is formally admitted into the
in-patient service is made by the
hospital or clinic. Treatment in an
Emergency Room only is not reportable.
I. Work-Relatedness Determinations
Given the nature of the disease, and
the extent of community spread, in
some cases, it may be difficult for an
employer to determine whether an
employee’s COVID–19 illness is work-
related, especially when an employee
has experienced potential exposure both
in and out of the workplace. For
purposes of this ETS, when evaluating
whether a fatality or in-patient
hospitalization is the result of a work-
related case of COVID–19, employers
must follow the criteria in OSHA’s
recordkeeping regulation at 29 CFR
1904.5 for determining work-
relatedness. Applying the criteria in 29
CFR 1904.5 under paragraph (k) of this
ETS is consistent with how employers
make work-relatedness determinations
when reporting fatalities and other
serious events under 29 CFR 1904.39.
Under § 1904.5, employers must
consider an injury or illness to be work-
related if an event or exposure in the
work environment either caused or
contributed to the resulting condition,
or significantly aggravated a pre-existing
injury or illness. An injury or illness is
presumed work-related if it results from
events or exposures occurring in the
work environment, unless an exception
in § 1904.5(b)(2) specifically applies.
Under this language, an injury or illness
is presumed work-related if an event or
exposure in the work environment is a
discernable cause of the injury or illness
(see 66 FR 66,943 (December 27, 2001)).
According to 29 CFR 1904.5(b)(3), the
‘‘work environment’’ includes the
employer’s establishment and any other
location where work is performed or
where employees are present as a
condition of their employment. Under
29 CFR 1904.5(b)(3), employers should
evaluate the employee’s work duties
and environment and determine
whether it is more likely than not that
exposure at work caused or contributed
to the illness (see 66 FR 5958–59
(January 19, 2001)).
Because of the typical incubation
period of 3 to 14 days, an employee’s
exposure to COVID–19 will usually be
determined after the fact. Employers
must make reasonable efforts to acquire
the necessary information to make good-
faith work-relatedness determinations
under this section. In addition, the
employer should rely on information
that is reasonably available at the time
of the fatality or in-patient
hospitalization.
A work-related exposure in the work
environment would likely include close
contact with a person known to be
infected with COVID–19. For example,
although work-relatedness must be
determined on a case-by-case basis, if a
number of COVID–19 illnesses develop
among coworkers who work closely
together without an alternative
explanation, it is reasonable to conclude
that an employee’s fatality or in-patient
hospitalization is work-related. On the
other hand, if there is not a known
exposure to COVID–19 that would
trigger the presumption of work-
relatedness, the employer must evaluate
the employee’s work duties and
environment to determine whether it is
more likely than not that the employee
was exposed to COVID–19 during the
course of their employment. Employers
should consider factors such as:
• The type, extent, and duration of
contact the employee had at the work
environment with other people,
particularly the general public.
• Physical distancing and other
controls that impact the likelihood of
work-related exposure.
• The extent and duration of time
spent in a shared indoor space with
limited ventilation.
• Whether the employee had work-
related contact with anyone who
exhibited signs and symptoms of
COVID–19.
Since 1971, under OSHA’s
recordkeeping system, employers have
been making work-relatedness
determinations regarding workplace
fatalities, injuries, and illnesses. In
general, employers are in the best
position to obtain information, both
from the employee and the workplace,
necessary to make a work-relatedness
determination. Although employers may
rely on experts and healthcare
professionals for guidance, the
determination of work-relatedness
ultimately rests with the employer.
Finally, OSHA wishes to emphasize
that, under OSHA’s recordkeeping
regulation at 29 CFR 1904, employers
must record on the OSHA 300 log each
work-related fatality, injury, and illness
reported to OSHA under § 1904.39. The
work-relatedness determination for
fatality and in-patient hospitalization is
no different than the requirement to
determine work-relatedness when
entering fatalities, injuries and illness
on the OSH 300 log. Accordingly, the
work-relatedness determination for
reporting COVID–19 fatalities and in-
patient hospitalizations is a
determination that is already required to
be made by the employer.
II. Time Periods for Reporting COVID–
19 Fatalities and In-Patient
Hospitalizations
As noted above, under paragraph (k),
employers must report each work-
related COVID–19 fatality or
hospitalization to OSHA within the
specified timeframes based on when any
agent or employee of the employer
becomes aware of the reportable event.
For example, an employer ‘‘learns’’ of a
COVID–19 fatality or in-patient
hospitalization when a supervisor,
receptionist, or other employee at the
company receives information from a
family member or medical professional
about an employee fatality or in-patient
hospitalization. It is the employer’s
responsibility to ensure that appropriate
instructions and procedures are in place
so that managers, supervisors, medical
personnel, as well as other employees or
agents of the company, who learn of an
employee’s death or in-patient
hospitalization due to COVID–19 know
that the company must make a report to
OSHA.
Consistent with OSHA’s regulation at
29 CFR 1904.39, the reporting clock
begins to run with the occurrence of the
reportable event. Under paragraph (k),
in situations where the employer or the
employer’s agent does not learn about
the work-related COVID–19 fatality or
in-patient hospitalization right away,
the employer must make the report to
OSHA within 8 hours for a fatality, or
24 hours for an in-patient
hospitalization, from the time the
employer (or the employer’s agent)
learns about the reportable event. For
example, if an employee dies from a
work-related case of COVID–19 on
Sunday at 6:00 a.m., but the employer
does not learn about the death until
Monday at 8:00 a.m., the employer has
until 4:00 p.m. that day to make the
report to OSHA. Similarly, if an
employee is in-patient hospitalized for a
work-related case of COVID–19 at 8:30
p.m. on Monday, but the employer or
the employer’s agent(s) does not learn
about the hospitalization until 9:00 a.m.
the next day (Tuesday), then the
employer would be required to make the
report to OSHA within 24 hours of
learning of the in-patient hospitalization
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(i.e., by 9:00 a.m. on Wednesday) (see 29
CFR 1904.39(b)(7)).
Likewise, if an employer does not
learn right away that a reportable
fatality or in-patient hospitalization is
work-related, the employer must make
the report to OSHA within 8 hours or
24 hours of learning that the death or in-
patient hospitalization was the result of
a work-related COVID–19 exposure. For
example, if an employee is in-patient
hospitalized for a case of COVID–19 at
9:00 a.m. on Monday, but the employer
does not have enough information to
make a work-relatedness determination
until 11:00 a.m. on Monday, then the
employer would be required to report
the hospitalization within 24 hours of
learning that the hospitalization was
work-related (i.e., by 11:00 a.m. on
Tuesday) (see 29 CFR 1904.39(b)(8)).
Finally, if an employer makes a report
to OSHA concerning a work-related
COVID–19 in-patient hospitalization
and that employee subsequently dies
from the illness, the employer does not
need to make an additional fatality
report to OSHA.
III. How To Report COVID–19 Fatalities
and In-Patient Hospitalizations and
What Information Must Be Included in
the Report
Paragraph (k)(2) of the standard
provides that when reporting work-
related COVID–19 fatalities and in-
patient hospitalizations to OSHA in
accordance with paragraph (k)(1), the
employer must follow the requirements
in 29 CFR 1904.39, except for 29 CFR
parts 1904.39(a)(1)–(2) and (b)(6). As
explained above, OSHA has included
specific provisions for the reporting of
work-related COVID–19 fatalities and
in-patient hospitalizations that differ
from 29 CFR 1904.39. However, when
making COVID–19 fatality and in-
patient hospitalization reports to OSHA,
employers must follow the other
reporting procedures set forth in
§ 1904.39. Specifically, under
§ 1904.39(a)(3), employers have three
options for reporting work-related
fatalities and in-patient hospitalizations
to OSHA:
1. By telephone to the OSHA Area
Office that is nearest to the site of the
incident;
2. by telephone to the OSHA toll-free
central telephone number, 1–800–321–
OSHA (1–800–321–6742);
3. by electronic submission using the
reporting application located on
OSHA’s public website at
www.osha.gov.
Section 1904.39(a)(3) also allows
employers to report work-related
fatalities and in-patient hospitalizations
to OSHA in person to the OSHA Area
Office that is nearest to the site of the
incident. However, because many
OSHA Area Offices are closed to the
public during the COVID–19 pandemic,
employers must use one of the three
options listed above. In addition,
§ 1904.39(b)(1) makes clear that, if the
OSHA Area Office is closed, an
employer may not report a work-related
fatality or in-patient hospitalization by
leaving a message on OSHA’s answering
machine, faxing the Area Office, or
sending an email. Instead, the employer
must make the report by using the 800
number or the reporting application
located on OSHA’s public website at
www.osha.gov.
The other provisions in 29 CFR
1904.39 (except for 29 CFR
1904.39(a)(1)–(2) and (b)(6)) also apply
to the reports required by paragraph (k).
For example, employers should consult
29 CFR 1904.39(b)(2) to determine what
information employers must give to
OSHA when making COVID–19 fatality
or in-patient hospitalization reports. Per
that provision, employers must give
OSHA the following information for
each fatality or in-patient
hospitalization: The establishment
name, the location of the work-related
incident, the time of the work-related
incident, the type of reportable event
(i.e., fatality or in-patient
hospitalization), the number of
employees who suffered a fatality or in-
patient hospitalization, the names of the
employees who suffered a fatality or in-
patient hospitalization, the employer’s
contact person and his or her phone
number, and a brief description of the
work-related incident.
References
Centers for Disease Control and Prevention.
(2020, May 20). Reporting and Coding
Deaths Due to COVID–19. https://
www.cdc.gov/nchs/covid19/coding-and-
reporting.htm. (CDC, May 20, 2020).
Pappas, S. (2020, May 19). How COVID–19
Deaths are Counted. Scientific American.
https://www.scientificamerican.com/
article/how-covid-19-deaths-are-
counted1/. (Pappas, May 19, 2020).
L. Availability of Records
Section 8(c)(1) of the Act requires
employers to ‘‘make, keep and preserve,
and make available to the Secretary [of
Labor] or the Secretary of Health and
Human Services, such records regarding
his activities relating to this Act as the
Secretary, in cooperation with the
Secretary of Health and Human
Services, may prescribe by regulation as
necessary or appropriate for the
enforcement of this Act or for
developing information regarding the
causes and prevention of occupational
accidents and illnesses.’’ Section 8(c)(2)
of the Act specifically directs the
Secretary of Labor to promulgate
regulations requiring employers to
maintain accurate records of work-
related injuries and illnesses. Section
8(c)(3) of the Act requires employers to
‘‘maintain accurate records of employee
exposures to potentially toxic materials
or harmful physical agents which are
required to be monitored or measured
under section 6 [of the Act.]’’ In
accordance with section 8(c), paragraph
(l) of the ETS includes availability of
records requirements for certain
COVID–19-related records required to
be created and maintained by the ETS.
This paragraph provides a right of
access to records by employees,
employee representatives, and OSHA.
Paragraph (l)(1) specifies that the
employer must make available, for
examination and copying, the
individual COVID–19 vaccine
documentation and any COVID–19 test
results required by the ETS for a
particular employee to that employee
and to anyone having written
authorized consent of that employee by
the end of the next business day after a
request. Prompt employee access to this
information ensures that employees
have the information necessary to take
an active role in their employers’ efforts
to prevent COVID–19 transmission in
the workplace. In particular, in
circumstances where employers or
employees choose to have the
employee’s COVID–19 test results go
directly to the employer, paragraph
(l)(1) gives the employee access to their
own records. Access to COVID–19 test
results may be helpful for a requesting
employee in evaluating information
relevant to COVID–19 exposure,
including if that exposure occurred at
the workplace. Prompt production of
these records can also assist employees
in making personal medical decisions
and seeking care from a licensed
healthcare provider if necessary.
Employers should note that employee
privacy is protected under the access to
records provisions in paragraph (l)(1).
Specifically, as noted above, paragraph
(l)(1) requires employers to provide
access to the vaccination records or
COVID–19 test results for a particular
employee to that employee or to anyone
having that employee’s written
permission. However, it does not
authorize employers to allow anyone
other than the particular employee to
access their records or results without
the written consent of that employee
(except as provided for under paragraph
(l)(3)).
Paragraph (l)(2) requires the employer
to make the following information
available to an employee or an
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employee representative on request: (1)
The aggregate number of fully
vaccinated employees at a workplace
and (2) the total number of employees
at that workplace. This information
must be made available to these
individuals by the end of the next
business day after a request. Employers
will be able to utilize the roster of each
employee’s vaccination status they are
required to maintain under paragraph
(e)(4) of this section to provide this
information promptly to a requester.
Since the aggregate totals of fully
vaccinated employees and total
employees made available by request in
paragraph (l)(2) do not contain any
personal identifiable information or
personal medical information, OSHA
does not believe that access to these
records raises any serious
confidentiality or privacy concern if
disclosed to employees or their
representatives.
OSHA believes that access to this
information will allow employees and
employee representatives to calculate a
percentage of fully vaccinated
employees at a workplace, evaluate the
efficacy of the employer’s vaccination
policy, raise any concerns identified to
OSHA, and actively participate in the
employer’s vaccination efforts. Without
the provision of this information to
employees and their representatives, the
only potential check on whether the
employer is complying with the
requirements of the ETS would be
OSHA inspections. The agency believes
that making this information available
to employee representatives will help
ensure compliance with the
requirements of the ETS and thereby
protect workers.
Consistent with 29 CFR 1904.35(a)(3),
OSHA interprets the term ‘‘employee’’
as used in paragraph (l) to include
former employees. In addition, for
purposes of paragraph (l)(2), the term
‘‘representative’’ is intended to have the
same meanings as in 29 CFR
1904.35(b)(2), which encompasses two
types of employee representatives. The
first is a personal representative of the
employee, who is a person the employee
designates, in writing, as his or her
personal representative, or is a legal
representative of a deceased or legally
incapacitated employee. The second is
an authorized representative, which is
defined as an authorized collective
bargaining agent of one or more
employees working at the employer’s
worksite. In accordance with these
interpretations, OSHA also interprets
the phrase ‘‘employee representative,’’
as used in paragraph (l)(2), to include
the personal and authorized
representatives of former employees.
These interpretations are limited to
these provisions.
Under paragraphs (l)(1) and (l)(2),
requesters are entitled to one free copy
of each requested record, which is
consistent with OSHA’s recordkeeping
regulation at 29 CFR 1904.35. The cost
of providing one free copy to
employees, former employees, and/or
their representatives is minimal, and
these individuals are more likely to
access the records if it is without cost.
Allowing the employer to charge for a
copy of the record would only delay the
production of the information. After
receiving an initial, free copy of a
requested record or document, an
employee, former employee, or
representative may be charged a
reasonable fee for copying duplicative
records. However, no fee may be
charged for an update to a previously
requested record. It should be noted that
each COVID–19 test is a separate record,
and, as such, the employee or the
representative is entitled to one free
copy of each COVID–19 test record.
Paragraph (l)(3) provides OSHA with
a specific right of access. Under
paragraph (l)(3)(i), employers must
provide the written policy required by
paragraph (d), and the aggregate
numbers described in paragraph (l)(2) of
this section (both the aggregate number
of fully vaccinated employees at a
workplace and the total number of
employees at that workplace), to the
Assistant Secretary for examination and
copying within 4 business hours of a
request. Consistent with the
requirements in 29 CFR 1904.40(b)(2), if
the records are maintained at a location
in a different time zone, the employer
may use the business hours of the
establishment at which the records are
located when calculating the deadline.
Providing OSHA with prompt access
to the written policy and the aggregate
numbers allows the agency to more
rapidly focus inspections on employers
that may not be in compliance with the
requirements of this ETS. In addition,
this information will help OSHA
determine what to focus on in an
investigation. For example, if an
employer has established, implemented,
and is enforcing a written mandatory
vaccination policy under paragraph
(d)(1) and their aggregate numbers
indicate that their entire workforce is
fully vaccinated against COVID–19, the
agency might approach the investigation
differently than in a workplace where
the employer’s written policy (under
paragraph (d)(2)) allows employees to
provide proof of regular testing for
COVID–19 in accordance with
paragraph (g) and wear a face covering
in accordance with paragraph (i),
instead of being fully vaccinated. This
information also provides OSHA
representatives with the ability to
quickly check any vaccination claims
made by an employer without
undertaking an employee-by-employee
assessment and assists OSHA
representatives in their evaluation of the
effectiveness of the employer’s written
policy.
Having this information within 4
business hours of the request helps the
agency act more quickly to protect
employees and preserves agency
resources. In addition, the 4-hour
response time is consistent with similar
obligations under other OSHA
recordkeeping requirements, such as the
recordkeeping requirement in 29 CFR
1904.40(a).
Paragraph (l)(3)(ii) requires employers
to provide all other records and other
documents that are required to be
maintained by this section to the
Assistant Secretary for examination and
copying by the end of the next business
day after a request. This means that
employers must allow OSHA
representatives to examine and copy
each employee’s COVID–19 vaccine
documentation (required to be
maintained under paragraph (e)(4)), the
roster of employee vaccination status
(required to be maintained under
paragraph (e)(4)), and each employee’s
COVID–19 test results (required to be
maintained under paragraph (g)(4)),
upon request.
As indicated in paragraph (c), the
term Assistant Secretary includes the
Assistant Secretary’s designees.
Consequently, the records and
information required to be provided to
the Assistant Secretary under paragraph
(l)(3) must be given to the Assistant
Secretary or their representatives, such
as OSHA’s Compliance Safety and
Health Officers.
As noted above, section 8 of the OSH
Act recognizes OSHA’s right of access to
records relating to employer compliance
with occupational safety and health
standards and regulations, including
access to relevant employee medical
records. OSHA does not believe that its
inspectors need to obtain employee
permission to access and review
personally identifiable information.
Gaining this permission would
essentially make it impossible to obtain
full access to the records in a timely
manner, which is needed by OSHA to
perform a meaningful workplace
investigation. OSHA also has policies
and procedures in place to ensure the
privacy and confidentiality of employee
records it accesses during inspections.
Finally, without complete and timely
access to the vaccine and testing
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records, agency efforts to conduct
immediate interventions to ensure
employees are protected from COVID–
19 at a specific workplace would be
limited.
OSHA does not prescribe specific
methods for requests for records in this
ETS. Employees, employee
representatives, and the Assistant
Secretary and designees can submit
requests in any manner that provides
adequate notice of the request to the
employer. This may include requests by
in writing (e.g., email, fax, letter), by
phone, or in person.
M. Dates
To minimize transmission of COVID–
19 in the workplace, it is essential that
employers ensure that the provisions of
this ETS are implemented as quickly as
possible, but no later than the dates
outlined in paragraph (m). This
paragraph sets forth the effective date of
the section and the compliance dates for
specific requirements of the standard.
The effective date for this ETS, as
required by section 6(c)(1) of the OSH
Act (29 U.S.C. 655(c)(1)), is the date of
publication in the Federal Register. The
compliance date for all provisions in the
ETS is 30 days after the effective date,
except for paragraph (g) (COVID–19
testing for employees who are not fully
vaccinated), which requires compliance
within 60 days of the effective date.
Given the grave danger to employees
from occupational exposure to COVID–
19, as previously described, the effective
date and compliance dates provided for
this ETS are reasonable and appropriate.
For over a year and a half—since at
least January 2020, when the Secretary
of Health and Human Services declared
COVID–19 to be a public health
emergency for the entire United States—
all employers have been made acutely
aware of the importance of minimizing
employees’ exposure to COVID–19 and
many have willingly joined the global
response to stop the spread of COVID–
19 and to protect their employees.
Therefore, many employers have
already been encouraging their
employees to get vaccinated against
COVID–19. Many employers have also
instituted vaccination mandates (see
Technological Feasibility, Section IV.A.
of this preamble, for more information).
OSHA has published this ETS
because there is great urgency in
instituting the workplace protections
OSHA has found to be necessary as
quickly as possible. Unvaccinated
workers are being hospitalized with
COVID–19 every day, and many are
dying, so it is particularly critical to
remove obstacles as soon as possible for
those who wish to be vaccinated. At the
same time, OSHA has set the
compliance dates to allow enough time
for employers to obtain and read the
standard, become knowledgeable about
the standard’s requirements, and
undertake the necessary steps for
compliance.
OSHA anticipates that employers will
be able to implement measures to
comply with most provisions of the ETS
well within 30 days, pursuant to
paragraph (m)(2)(i). Even in situations
where an employer has not previously
taken the required actions to address
COVID–19 hazards in the workplace,
steps such as developing a vaccination
policy, determining employee
vaccination status, providing support
for employee vaccination, ensuring
employees who are not fully vaccinated
wear face coverings, and most other
measures required under the standard
can readily be completed within the 30-
day time period. These measures do not
require extensive lead times for large
employers to implement. The scope of
the standard is limited to employers
with more than 100 employees largely
because OSHA is especially confident
that these employers will have the
ability to implement the standard.
Paragraph (m)(2)(ii) of the ETS
provides a longer period of time—60
days—for employers to comply with the
requirements for COVID–19 testing in
paragraph (g). Paragraph (g) requires
employers to implement COVID–19
testing and reporting of results for
employees who are not fully vaccinated.
One reason for this extended period of
time for testing is that employers may
need additional time to develop policies
and procedures regarding COVID–19
testing and associated recordkeeping.
Perhaps more critically, this ETS is
intended to incentivize vaccination, so
this delayed compliance date was
established to allow sufficient time for
employees to complete a COVID–19
primary vaccination before it is
necessary to comply with the testing
requirements in paragraph (g). The 60-
day compliance period in paragraph
(m)(2)(ii) provides employees with
sufficient time to receive one dose of a
single-dose primary vaccination (e.g.,
Janssen (Johnson & Johnson)) or both
doses of a two-dose primary vaccination
series (e.g., Pfizer-BioNTech, Moderna).
For the Janssen COVID–19 vaccine, the
primary vaccination takes 1 day to
complete (CDC, August 10, 2021).
Employees who receive the Janssen
vaccine could therefore begin their
primary vaccination at any time up to
and including the 60th day from the
date of publication in the Federal
Register in order to be exempt from the
testing requirements of paragraph (g).
For the Pfizer-BioNTech COVID–19
vaccine, the primary vaccination series
takes 21 days to complete (CDC, August
25, 2021). Employees receiving the
Pfizer-BioNTech series could begin their
primary vaccination series up to 39 days
from the date of publication in the
Federal Register. Finally, for the
Moderna COVID–19 vaccine, the
primary vaccination series takes 28 days
to complete (CDC, August 23, 2021).
Employees receiving the Moderna series
could therefore begin their primary
vaccination series up to 32 days from
the date of publication in the Federal
Register.
As specified in paragraph (m)(2)(ii), if
an employee completes the entire
primary vaccination within 60 days
following publication in the Federal
Register, that employee does not have to
be tested under paragraph (g), even if
they have not yet completed the two
week waiting period that is required to
meet the definition of fully vaccinated
in paragraph (c). Employers must begin
compliance with the testing
requirements of paragraph (g) only for
employees who have not yet completed
primary vaccination (i.e., employees
who have not received any doses,
employees who have received only one
dose of a two-dose series) within 60
days from the date of publication in the
Federal Register. And because
employers must have their vaccination
support processes (as required by
paragraph (f)) in place before employees
would need to initiate their primary
vaccination in time to avoid testing
under this section, employees will be
able to avoid all testing costs required
by this ETS.
Compliance with the requirements of
the ETS within the specified dates is
achievable. Many employers are likely
already in compliance with at least
some of the provisions of the ETS.
Resources are also readily available to
help employers achieve compliance.
These resources include guidance
issued by OSHA, the CDC, state and
local governments, trade associations,
and other organizations to help
employers successfully implement
vaccination, testing, and face covering
requirements to minimize the
transmission of COVID–19 in the
workplace. OSHA therefore concludes
that the compliance dates in this ETS
strike a reasonable balance between
incentivizing vaccination and allowing
enough time for employers to comply.
Although employers are not required
to comply with the requirements of this
ETS until 30 days from the date of
publication in the Federal Register (60
days for paragraph (g)), OSHA strongly
encourages employers to implement the
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required measures to support employee
vaccination as soon as practicable.
Providing support for employees to
receive the COVID–19 vaccine and
recover from side effects, as required in
paragraph (f) of the ETS, prior to the
compliance date may encourage
employees to receive a COVID–19
vaccination at the earliest possible date.
This would not only reduce the grave
danger of COVID–19 in the workplace
but also reduce burdens on both
employers and employees when the
compliance dates for the additional
requirements for employees who are not
fully vaccinated arrive.
References
Centers for Disease Control and Prevention
(CDC). (2021, August 10). Janssen
COVID–19 Vaccine (Johnson & Johnson).
https://www.cdc.gov/vaccines/covid-19/
info-by-product/moderna/index.html.
(CDC, August 10, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, August 23). Moderna
COVID–19 Vaccine. https://
www.cdc.gov/vaccines/covid-19/info-by-
product/moderna/index.html. (CDC,
August 23, 2021)
Centers for Disease Control and Prevention
(CDC). (2021, August 25). Pfizer-
BioNTech COVID–19 Vaccine. https://
www.cdc.gov/vaccines/covid-19/info-by-
product/pfizer/index.html. (CDC, August
25, 2021)
N. Severability
OSHA’s amendment to its COVID–19
ETS, Part 1910, Subpart U, includes a
republication of § 1910.505,
Severability. Section 1910.505 contains
a severability clause, the primary
purpose of which is to express OSHA’s
intent that if any section or provision of
the COVID–19 ETS is held invalid or
unenforceable or is stayed or enjoined
by any court of competent jurisdiction,
the remaining sections or provisions
should remain effective and operative.
OSHA is including 29 CFR 1910.505 as
part of this ETS for the same reasons the
agency included the provision in the
Healthcare ETS, and OSHA intends for
it to have the same purposes and effects
as those expressed in the preamble to
the Healthcare ETS (86 FR 32617–
32618), which is hereby included in the
record for this ETS.
Because subpart U is the result of two
separate ETSs published at different
times and subject to different time
frames, but OSHA intends for both ETSs
to be subject to the same principles of
severability, OSHA has relied on the
same centralized severability section for
both for efficiency. For the benefit of the
reader and for administrative
convenience, this centralized
severability section is located in the
same subpart as the other provisions of
the ETS. While either ETS remains in
effect, it is OSHA’s intent that 29 CFR
1910.505 remain in subpart U and
operative as to either ETS still in effect.
If both ETSs are not made permanent,
29 CFR 1910.505 will cease to have
effect along with the rest of subpart U.
If either ETS is made permanent, OSHA
will provide notice at that time of the
agency’s intended application of 29 CFR
1910.505 to the newly permanent
standard. For example, if 29 CFR
1910.502 becomes permanent because it
has been finalized, but 29 CFR 1910.501
remains a temporary requirement
because it is not yet finalized, 29 CFR
1910.505 would remain in subpart U
and operative as to 29 CFR 1910.501
and the agency would separately
provide notice of how severability is
intended to apply to the newly
permanent 29 CFR 1910.502.
O. Incorporation by Reference
OSHA’s amendment to its COVID–19
ETS, Part 1910, Subpart U, includes the
addition of § 1910.501, Vaccination,
Testing, and Face Coverings. This
section incorporates by reference CDC’s
‘‘Isolation Guidance.’’
This document, listed below, will be
fixed in time and made publicly
available. OSHA had previously
incorporated this same document into
29 CFR 1910.502 and listed it in subpart
U’s incorporation by reference (IBR)
section, 29 CFR 1910.509. Because
subpart U is the result of two separate
ETSs published at different times and
subject to different time frames, but both
incorporate documents by reference,
OSHA has relied on the same
centralized IBR section for both. For the
benefit of the reader and for
administrative convenience, this
centralized IBR section is located in the
same subpart as the other provisions of
the ETS.
While either ETS remains in effect, it
is OSHA’s intent that 29 CFR 1910.509
remain in subpart U. If both ETSs are
not made permanent, 29 CFR 1910.509
will cease to have effect along with the
rest of subpart U. If either ETS is made
permanent, OSHA intends to recodify
the relevant standards for that ETS from
29 CFR 1910.509 into 29 CFR 1910.6,
the centralized IBR section for part
1910. For example, if 29 CFR 1910.502
becomes permanent because it has been
finalized, but 29 CFR 1910.501 remains
a temporary requirement because it is
not yet finalized, OSHA would relocate
all of 29 CFR 1910.502’s incorporated
documents into 29 CFR 1910.6, but 29
CFR 1910.509 would remain in subpart
U and would list the one document
incorporated by reference into 29 CFR
1910.501.
In this section, OSHA includes a list
of the titles, editions/versions, and years
of the incorporated documents.
Stakeholders may consult 29 CFR
1910.509 both to locate all of the
documents incorporated by reference in
subpart U (the paragraph in which the
document is incorporated is listed there)
and to find more details regarding how
to locate the specific consensus
standard and guidelines that have been
incorporated by reference in the ETS.
OSHA recognizes that the Centers for
Disease Control and Prevention (CDC)
may update their guidelines based on
the most current available scientific
evidence, but OSHA is only requiring
compliance with CDC’s ‘‘Isolation
Guidance’’ as incorporated by reference,
which is fixed in time as of February 18,
2021.
As discussed in the preamble of the
Healthcare ETS at 86 FR 32619, CDC’s
guidance, including its ‘‘Isolation
Guidance,’’ is not expressed in
mandatory terms. As such, OSHA has
determined it is not sufficiently
protective or a meaningful alternative to
a mandatory standard. OSHA has
reviewed this guidance and determined
that compliance with the safety
measures and specific instructions in
CDC’s ‘‘Isolation Guidance’’ is
important to protect workers who work
for employees with over 100 employees.
For the same reasons as described in the
Healthcare ETS (86 FR 32619), OSHA is
incorporating this guidance by
reference, and compliance with the
recommendations will be mandatory.
OSHA will be able to cite employers
who do not follow them. Compliance
with all applicable provisions of the
incorporated document is required
where the provisions into which they
are incorporated are mandatory,
whether the incorporated document sets
out its directions in mandatory language
or recommendations. OSHA recognizes
that this document incorporated by
reference into the ETS may become
outdated when newer versions are
published or other entities revise those
documents. In that case, OSHA will
work quickly to update the ETS through
a new rulemaking or issue enforcement
guidance, as appropriate. But OSHA
also has a longstanding de minimis
enforcement policy to allow employers
to rely on documents that are at least as
protective.
OSHA is incorporating by reference
(in 29 CFR 1910.509) the material
below. A brief description of the
guidance is provided in the text below.
A description of its use can be found in
the Regulatory Text, and Summary and
Explanation (Section VI. of this
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preamble), where the guidance is
referenced.
Regulatory Text—§§ 1910.501(h);
1910.502(l)
CDC’s Isolation Guidance (2021): This
guidance provides steps to take when
someone is experiencing COVID–19
symptoms and/or tested positive for
COVID–19. This document is available
at www.osha.gov/coronavirus/ets/ibr.
The CDC document is available at no
cost through the contact information
listed above. In addition, in accordance
with § 1910.509(a)(1), this guidance is
available for inspection at any Regional
Office of the Occupational Safety and
Health Administration (OSHA), or at the
OSHA Docket Office, U.S. Department
of Labor, 200 Constitution Avenue NW,
Room N–3508, Washington, DC 20210;
telephone: 202–693–2350 (TTY number:
877–889–5627). Due to copyright issues,
OSHA cannot post consensus standards
on the OSHA website or through
www.regulations.gov.
List of Subjects
29 CFR Part 1910
COVID–19, Disease, Health, Health
care, Health facilities, Incorporation by
reference, Occupational safety and
health, Public health, Quarantine,
Reporting and recordkeeping
requirements, Respirators, SARS–CoV–
2, Telework, Vaccines, Viruses.
29 CFR Parts 1915, 1917, 1918, 1926,
and 1928
COVID–19, Disease, Health, Health
care, Health facilities, Occupational
safety and health, Public health,
Quarantine, Reporting and
recordkeeping requirements,
Respirators, SARS–CoV–2, Telework,
Vaccines, Viruses.
Authority and Signature
James S. Frederick, Acting Assistant
Secretary of Labor for Occupational
Safety and Health, U.S. Department of
Labor, authorized the preparation of this
document pursuant to the following
authorities: Sections 4, 6, and 8 of the
Occupational Safety and Health Act of
1970 (29 U.S.C. 653, 655, 657); Secretary
of Labor’s Order 8–2020 (85 FR 58393
(Sept. 18, 2020)); 29 CFR part 1911; and
5 U.S.C. 553.
James S. Frederick,
Acting Assistant Secretary of Labor for
Occupational Safety and Health.
For the reasons set forth in the
preamble, chapter XVII of title 29 of the
Code of Federal Regulations is amended
as follows:
PART 1910—OCCUPATIONAL SAFETY
AND HEALTH STANDARDS
Subpart U—COVID–19
■1. Revise the heading for Subpart U to
read as set forth above.
■2. The authority citation for subpart U
continues to read as follows:
Authority: 29 U.S.C. 653, 655, and 657;
Secretary of Labor’s Order No. 8–2020 (85 FR
58393); 29 CFR part 1911; and 5 U.S.C. 553.
■3. Add § 1910.501 to subpart U to read
as follows:
§ 1910.501
Vaccination, testing, and face
coverings.
(a) Purpose. This section is intended
to establish minimum vaccination,
vaccination verification, face covering,
and testing requirements to address the
grave danger of COVID–19 in the
workplace, and to preempt inconsistent
state and local requirements relating to
these issues, including requirements
that ban or limit employers’ authority to
require vaccination, face covering, or
testing, regardless of the number of
employees.
Note 1 to paragraph (a): This section
establishes minimum requirements that
employers must implement. Nothing in this
section prevents employers from agreeing
with workers and their representatives to
additional measures not required by this
section and this section does not supplant
collective bargaining agreements or other
collectively negotiated agreements in effect
that may have negotiated terms that exceed
the requirements herein. The National Labor
Relations Act of 1935 (NLRA) protects the
right of most private-sector employees to take
collective action to improve their wages and
working conditions.
(b) Scope and application. (1) This
section covers all employers with a total
of 100 or more employees at any time
this section is in effect.
(2) The requirements of this section
do not apply to:
(i) Workplaces covered under the
Safer Federal Workforce Task Force
COVID–19 Workplace Safety: Guidance
for Federal Contractors and
Subcontractors; or
(ii) Settings where any employee
provides healthcare services or
healthcare support services when
subject to the requirements of
§ 1910.502.
(3) The requirements of this section
do not apply to the employees of
covered employers:
(i) Who do not report to a workplace
where other individuals such as
coworkers or customers are present;
(ii) While working from home; or
(iii) Who work exclusively outdoors.
(c) Definitions. The following
definitions apply to this section.
Assistant Secretary means the
Assistant Secretary of Labor for
Occupational Safety and Health, U.S.
Department of Labor, or designee.
COVID–19 (Coronavirus Disease 2019)
means the disease caused by SARS–
CoV–2 (severe acute respiratory
syndrome coronavirus 2). For clarity
and ease of reference, this section also
uses the term ‘‘COVID–19’’ when
describing exposures or potential
exposures to SARS–CoV–2.
COVID–19 test means a test for SARS–
CoV–2 that is:
(i) Cleared, approved, or authorized,
including in an Emergency Use
Authorization (EUA), by the FDA to
detect current infection with the SARS–
CoV–2 virus (e.g., a viral test);
(ii) Administered in accordance with
the authorized instructions; and
(iii) Not both self-administered and
self-read unless observed by the
employer or an authorized telehealth
proctor. Examples of tests that satisfy
this requirement include tests with
specimens that are processed by a
laboratory (including home or on-site
collected specimens which are
processed either individually or as
pooled specimens), proctored over-the-
counter tests, point of care tests, and
tests where specimen collection and
processing is either done or observed by
an employer.
Face covering means a covering that:
(i)(A) completely covers the nose and
mouth;
(B) Is made with two or more layers
of a breathable fabric that is tightly
woven (i.e., fabrics that do not let light
pass through when held up to a light
source);
(C) Is secured to the head with ties,
ear loops, or elastic bands that go
behind the head. If gaiters are worn,
they should have two layers of fabric or
be folded to make two layers;
(D) Fits snugly over the nose, mouth,
and chin with no large gaps on the
outside of the face; and
(E) Is a solid piece of material without
slits, exhalation valves, visible holes,
punctures, or other openings.
(ii) This definition includes clear face
coverings or cloth face coverings with a
clear plastic panel that, despite the non-
cloth material allowing light to pass
through, otherwise meet this definition
and which may be used to facilitate
communication with people who are
deaf or hard-of-hearing or others who
need to see a speaker’s mouth or facial
expressions to understand speech or
sign language respectively.
Facemask means a surgical, medical
procedure, dental, or isolation mask that
is FDA-cleared, authorized by an FDA
EUA, or offered or distributed as
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described in an FDA enforcement
policy. Facemasks may also be referred
to as ‘‘medical procedure masks.’’
Fully vaccinated means:
(i) A person’s status 2 weeks after
completing primary vaccination with a
COVID–19 vaccine with, if applicable,
at least the minimum recommended
interval between doses in accordance
with the approval, authorization, or
listing that is:
(A) Approved or authorized for
emergency use by the FDA;
(B) Listed for emergency use by the
World Health Organization (WHO); or
(C) Administered as part of a clinical
trial at a U.S. site, if the recipient is
documented to have primary
vaccination with the active (not
placebo) COVID–19 vaccine candidate,
for which vaccine efficacy has been
independently confirmed (e.g., by a data
and safety monitoring board) or if the
clinical trial participant at U.S. sites had
received a COVID–19 vaccine that is
neither approved nor authorized for use
by FDA but is listed for emergency use
by WHO; or
(ii) A person’s status 2 weeks after
receiving the second dose of any
combination of two doses of a COVID–
19 vaccine that is approved or
authorized by the FDA, or listed as a
two-dose series by the WHO (i.e., a
heterologous primary series of such
vaccines, receiving doses of different
COVID–19 vaccines as part of one
primary series). The second dose of the
series must not be received earlier than
17 days (21 days with a 4-day grace
period) after the first dose.
Mandatory Vaccination Policy is an
employer policy requiring each
employee to be fully vaccinated. To
meet this definition, the policy must
require: Vaccination of all employees,
including vaccination of all new
employees as soon as practicable, other
than those employees:
(i) For whom a vaccine is medically
contraindicated;
(ii) For whom medical necessity
requires a delay in vaccination; or
(iii) Who are legally entitled to a
reasonable accommodation under
federal civil rights laws because they
have a disability or sincerely held
religious beliefs, practices, or
observances that conflict with the
vaccination requirement.
Respirator means a type of personal
protective equipment (PPE) that is
certified by the National Institute for
Occupational Safety and Health
(NIOSH) under 42 CFR part 84 or is
authorized under an EUA by the FDA.
Respirators protect against airborne
hazards by removing specific air
contaminants from the ambient
(surrounding) air or by supplying
breathable air from a safe source.
Common types of respirators include
filtering facepiece respirators (e.g., N95),
elastomeric respirators, and powered air
purifying respirators (PAPRs). Face
coverings, facemasks, and face shields
are not respirators.
Workplace means a physical location
(e.g., fixed, mobile) where the
employer’s work or operations are
performed. It does not include an
employee’s residence.
(d) Employer policy on vaccination.
(1) The employer must establish,
implement, and enforce a written
mandatory vaccination policy.
(2) The employer is exempted from
the requirement in paragraph (d)(1) of
this section only if the employer
establishes, implements, and enforces a
written policy allowing any employee
not subject to a mandatory vaccination
policy to choose either to be fully
vaccinated against COVID–19 or provide
proof of regular testing for COVID–19 in
accordance with paragraph (g) of this
section and wear a face covering in
accordance with paragraph (i) of this
section.
Note 1 to paragraph (d): Under federal law,
including the Americans with Disabilities
Act (ADA) and Title VII of the Civil Rights
Act of 1964, workers may be entitled to a
reasonable accommodation from their
employer, absent undue hardship. If the
worker requesting a reasonable
accommodation cannot be vaccinated and/or
wear a face covering because of a disability,
as defined by the ADA, the worker may be
entitled to a reasonable accommodation. In
addition, if the vaccination, and/or testing for
COVID–19, and/or wearing a face covering
conflicts with a worker’s sincerely held
religious belief, practice or observance, the
worker may be entitled to a reasonable
accommodation. For more information about
evaluating requests for reasonable
accommodation for disability or sincerely
held religious belief, employers should
consult the Equal Employment Opportunity
Commission’s regulations, guidance, and
technical assistance including at: https://
www.eeoc.gov/wysk/what-you-should-know-
about-covid-19-and-ada-rehabilitation-act-
and-other-eeo-laws.
(e) Determination of employee
vaccination status. (1) The employer
must determine the vaccination status of
each employee. This determination
must include whether the employee is
fully vaccinated.
(2) The employer must require each
vaccinated employee to provide
acceptable proof of vaccination status,
including whether they are fully or
partially vaccinated. Acceptable proof of
vaccination status is:
(i) The record of immunization from
a health care provider or pharmacy;
(ii) A copy of the COVID–19
Vaccination Record Card;
(iii) A copy of medical records
documenting the vaccination;
(iv) A copy of immunization records
from a public health, state, or tribal
immunization information system; or
(v) A copy of any other official
documentation that contains the type of
vaccine administered, date(s) of
administration, and the name of the
health care professional(s) or clinic
site(s) administering the vaccine(s);
(vi) In instances where an employee is
unable to produce acceptable proof of
vaccination under paragraphs (e)(2)(i)
through (v) of this section, a signed and
dated statement by the employee:
(A) Attesting to their vaccination
status (fully vaccinated or partially
vaccinated);
(B) Attesting that they have lost and
are otherwise unable to produce proof
required by this section; and
(C) Including the following language:
‘‘I declare (or certify, verify, or state)
that this statement about my vaccination
status is true and accurate. I understand
that knowingly providing false
information regarding my vaccination
status on this form may subject me to
criminal penalties.’’
Note 1 to paragraph (e)(2)(vi): An
employee who attests to their vaccination
status should, to the best of their recollection,
include the following information in their
attestation: The type of vaccine administered;
date(s) of administration; and the name of the
health care professional(s) or clinic site(s)
administering the vaccine(s).
(3) Any employee who does not
provide one of the acceptable forms of
proof of vaccination status in paragraph
(e)(2) of this section to the employer
must be treated as not fully vaccinated
for the purpose of this section.
(4) The employer must maintain a
record of each employee’s vaccination
status and must preserve acceptable
proof of vaccination for each employee
who is fully or partially vaccinated. The
employer must maintain a roster of each
employee’s vaccination status. These
records and roster are considered to be
employee medical records and must be
maintained as such records in
accordance with § 1910.1020 and must
not be disclosed except as required or
authorized by this section or other
federal law. These records and roster are
not subject to the retention requirements
of § 1910.1020(d)(1)(i) but must be
maintained and preserved while this
section remains in effect.
(5) When an employer has ascertained
employee vaccination status prior to the
effective date of this section through
another form of attestation or proof, and
retained records of that ascertainment,
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the employer is exempt from the
requirements in paragraphs (e)(1)
through (3) of this section only for each
employee whose fully vaccinated status
has been documented prior to the
effective date of this section. For
purposes of paragraph (e)(4) of this
section, the employer’s records of
ascertainment of vaccination status for
each such person constitute acceptable
proof of vaccination.
(f) Employer support for employee
vaccination. The employer must
support COVID–19 vaccination as
described in this paragraph.
(1) Time for vaccination. The
employer must:
(i) Provide a reasonable amount of
time to each employee for each of their
primary vaccination dose(s); and
(ii) Provide up to 4 hours paid time,
including travel time, at the employee’s
regular rate of pay for this purpose.
(2) Time for recovery. The employer
must provide reasonable time and paid
sick leave to recover from side effects
experienced following any primary
vaccination dose to each employee for
each dose.
(g) COVID–19 testing for employees
who are not fully vaccinated. (1) The
employer must ensure that each
employee who is not fully vaccinated
complies with paragraph (g)(1)(i) or (ii)
of this section:
(i) An employee who reports at least
once every 7 days to a workplace where
other individuals such as coworkers or
customers are present:
(A) Must be tested for COVID–19 at
least once every 7 days; and
(B) Must provide documentation of
the most recent COVID–19 test result to
the employer no later than the 7th day
following the date on which the
employee last provided a test result.
(ii) An employee who does not report
during a period of 7 or more days to a
workplace where other individuals such
as coworkers or customers are present
(e.g., teleworking for two weeks prior to
reporting to a workplace with others):
(A) Must be tested for COVID–19
within 7 days prior to returning to the
workplace; and
(B) Must provide documentation of
that test result to the employer upon
return to the workplace.
Note 1 to paragraph (g)(1): This section
does not require the employer to pay for any
costs associated with testing; however
employer payment for testing may be
required by other laws, regulations, or
collective bargaining agreements or other
collectively negotiated agreements. This
section also does not prohibit the employer
from paying for costs associated with testing
required by paragraph (g)(1) of this section.
(2) If an employee does not provide
documentation of a COVID–19 test
result as required by paragraph (g)(1) of
this section, the employer must keep
that employee removed from the
workplace until the employee provides
a test result.
(3) When an employee has received a
positive COVID–19 test, or has been
diagnosed with COVID–19 by a licensed
healthcare provider, the employer must
not require that employee to undergo
COVID–19 testing as required under
paragraph (g) of this section for 90 days
following the date of their positive test
or diagnosis.
(4) The employer must maintain a
record of each test result provided by
each employee under paragraph (g)(1) of
this section or obtained during tests
conducted by the employer. These
records are considered to be employee
medical records and must be
maintained as such records in
accordance with § 1910.1020 and must
not be disclosed except as required or
authorized by this section or other
federal law. These records are not
subject to the retention requirements of
§ 1910.1020(d)(1)(i) but must be
maintained and preserved while this
section remains in effect.
(h) Employee notification to employer
of a positive COVID–19 test and
removal. Regardless of COVID–19
vaccination status or any COVID–19
testing required under paragraph (g) of
this section, the employer must:
(1) Require each employee to
promptly notify the employer when
they receive a positive COVID–19 test or
are diagnosed with COVID–19 by a
licensed healthcare provider; and
(2) Immediately remove from the
workplace any employee who receives a
positive COVID–19 test or is diagnosed
with COVID–19 by a licensed healthcare
provider and keep the employee
removed until the employee:
(i) Receives a negative result on a
COVID–19 nucleic acid amplification
test (NAAT) following a positive result
on a COVID–19 antigen test if the
employee chooses to seek a NAAT test
for confirmatory testing;
(ii) meets the return to work criteria
in CDC’s ‘‘Isolation Guidance’’
(incorporated by reference, § 1910.509);
or
(iii) Receives a recommendation to
return to work from a licensed
healthcare provider.
Note 1 to paragraph (h)(2): This section
does not require employers to provide paid
time to any employee for removal as a result
of a positive COVID–19 test or diagnosis of
COVID–19; however, paid time may be
required by other laws, regulations, or
collective bargaining agreements or other
collectively negotiated agreements.
(i) Face coverings. (1) The employer
must ensure that each employee who is
not fully vaccinated wears a face
covering when indoors and when
occupying a vehicle with another
person for work purposes, except:
(i) When an employee is alone in a
room with floor to ceiling walls and a
closed door.
(ii) For a limited time while the
employee is eating or drinking at the
workplace or for identification purposes
in compliance with safety and security
requirements.
(iii) When an employee is wearing a
respirator or facemask.
(iv) Where the employer can show
that the use of face coverings is
infeasible or creates a greater hazard
that would excuse compliance with this
paragraph (e.g., when it is important to
see the employee’s mouth for reasons
related to their job duties, when the
work requires the use of the employee’s
uncovered mouth, or when the use of a
face covering presents a risk of serious
injury or death to the employee).
(2) The employer must ensure that
any face covering required to be worn
by this section:
(i) Is worn by the employee to fully
cover the employee’s nose and mouth;
and
(ii) Is replaced when wet, soiled, or
damaged (e.g., is ripped, has holes, or
has broken ear loops).
(3) The employer must not prevent
any employee from voluntarily wearing
a face covering or facemask unless the
employer can demonstrate that doing so
would create a hazard of serious injury
or death, such as interfering with the
safe operation of equipment.
(4) The employer must permit the
employee to wear a respirator instead of
a face covering whether required or not.
In addition, the employer may provide
respirators to the employee, even if not
required. In such circumstances, the
employer must also comply with
§ 1910.504.
(5) The employer must not prohibit
customers or visitors from wearing face
coverings.
Note 1 to paragraph (i)(5): Nothing in this
section precludes employers from requiring
customers or visitors to wear face coverings.
Note 1 to paragraph (i): Face shields may
be worn in addition to face coverings to
prevent them from getting wet and soiled.
Note 2 to paragraph (i): This section does
not require the employer to pay for any costs
associated with face coverings; however
employer payment for face coverings may be
required by other laws, regulations, or
collective bargaining agreements or other
collectively negotiated agreements. This
section also does not prohibit the employer
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from paying for costs associated with face
coverings required by this section.
(j) Information provided to employees.
The employer must inform each
employee, in a language and at a literacy
level the employee understands, about:
(1) The requirements of this section as
well as any employer policies and
procedures established to implement
this section;
(2) COVID–19 vaccine efficacy, safety,
and the benefits of being vaccinated, by
providing the document, ‘‘Key Things to
Know About COVID–19 Vaccines,’’
available at https://www.cdc.gov/
coronavirus/2019-ncov/vaccines/
keythingstoknow.html;
(3) The requirements of 29 CFR
1904.35(b)(1)(iv), which prohibits the
employer from discharging or in any
manner discriminating against an
employee for reporting a work-related
injuries or illness, and section 11(c) of
the OSH Act, which prohibits the
employer from discriminating against an
employee for exercising rights under, or
as a result of actions that are required
by, this section. Section 11(c) also
protects the employee from retaliation
for filing an occupational safety or
health complaint, reporting a work-
related injuries or illness, or otherwise
exercising any rights afforded by the
OSH Act; and
(4) The prohibitions of 18 U.S.C. 1001
and of section 17(g) of the OSH Act,
which provide for criminal penalties
associated with knowingly supplying
false statements or documentation.
(k) Reporting COVID–19 fatalities and
hospitalizations to OSHA. (1) The
employer must report to OSHA:
(i) Each work-related COVID–19
fatality within 8 hours of the employer
learning about the fatality.
(ii) Each work-related COVID–19 in-
patient hospitalization within 24 hours
of the employer learning about the in-
patient hospitalization.
(2) When reporting COVID–19
fatalities and in-patient hospitalizations
to OSHA in accordance with paragraph
(j)(1) of this section, the employer must
follow the requirements in 29 CFR part
1904.39, except for 29 CFR part
1904.39(a)(1) and (2) and (b)(6).
(l) Availability of records. (1) By the
end of the next business day after a
request, the employer must make
available, for examination and copying,
the individual COVID–19 vaccine
documentation and any COVID–19 test
results for a particular employee to that
employee and to anyone having written
authorized consent of that employee.
(2) By the end of the next business
day after a request by an employee or an
employee representative, the employer
must make available to the requester the
aggregate number of fully vaccinated
employees at a workplace along with
the total number of employees at that
workplace.
(3) The employer must provide to the
Assistant Secretary for examination and
copying:
(i) Within 4 business hours of a
request, the employer’s written policy
required by paragraph (d) of this
section, and the aggregate numbers
described in paragraph (l)(2) of this
section; and
(ii) By the end of the next business
day after a request, all other records and
other documents required to be
maintained by this section.
(m) Dates—(1) Effective date. This
section is effective as of November 5,
2021.
(2) Compliance dates. (i) Employers
must comply with all requirements of
this section, except for requirements in
paragraph (g) of this section, by
December 6, 2021.
(ii) Employers must comply with the
requirements of this section in
paragraph (g) by January 4, 2022, but
employees who have completed the
entire primary vaccination by that date
do not have to be tested, even if they
have not yet completed the 2-week
waiting period.
■4. Amend § 1910.504 by revising
paragraph (a) to read as follows:
§ 1910.504
Mini Respiratory Protection
Program.
(a) Scope and application. This
section applies only to respirator use in
accordance with §§ 1910.501(i)(4) and
1910.502(f)(4).
*
*
*
*
*
■5. Republish § 1910.505 to read as
follows:
§ 1910.505
Severability.
Each section of this subpart U, and
each provision within those sections, is
separate and severable from the other
sections and provisions. If any provision
of this subpart is held to be invalid or
unenforceable on its face, or as applied
to any person, entity, or circumstance,
or is stayed or enjoined, that provision
shall be construed so as to continue to
give the maximum effect to the
provision permitted by law, unless such
holding shall be one of utter invalidity
or unenforceability, in which event the
provision shall be severable from this
subpart and shall not affect the
remainder of the subpart.
■6. Amend § 1910.509 by revising
paragraph (b)(5) to read as follows:
§ 1910.509
Incorporation by reference.
*
*
*
*
*
(b) * * *
(5) Isolation Guidance. COVID–19:
Isolation If You Are Sick; Separate
yourself from others if you have
COVID–19, updated February 18, 2021,
IBR approved for §§ 1910.501(h) and
1910.502(l).
*
*
*
*
*
PART 1915—OCCUPATIONAL SAFETY
AND HEALTH STANDARDS FOR
SHIPYARD EMPLOYMENT
■7. The authority citation for part 1915
is revised to read as follows:
Authority: 33 U.S.C. 941; 29 U.S.C. 653,
655, 657; Secretary of Labor’s Order No. 12–
71 (36 FR 8754); 8–76 (41 FR 25059), 9–83
(48 FR 35736), 1–90 (55 FR 9033), 6–96 (62
FR 111), 3–2000 (65 FR 50017), 5–2002 (67
FR 65008), 5–2007 (72 FR 31160), 4–2010 (75
FR 55355), 1–2012 (77 FR 3912), or 8–2020
(85 FR 58393); 29 CFR part 1911; and 5
U.S.C. 553, as applicable.
Subpart Z—Toxic and Hazardous
Substances
■8. Add § 1915.1501 to subpart Z to
read as follows:
§ 1915.1501
COVID–19.
The requirements applicable to
shipyard employment under this section
are identical to those set forth at 29 CFR
1910.501.
PART 1917—MARINE TERMINALS
■9. The authority citation for part 1917
is revised to read as follows:
Authority: 33 U.S.C. 941; 29 U.S.C. 653,
655, 657; Secretary of Labor’s Order No. 12–
71 (36 FR 8754), 8–76 (41 FR 25059), 9–83
(48 FR 35736), 1–90 (55 FR 9033), 6–96 (62
FR 111), 3–2000 (65 FR 50017), 5–2002 (67
FR 65008), 5–2007 (72 FR 31160), 4–2010 (75
FR 55355), 1–2012 (77 FR 3912), or 8–2020
(85 FR 58393), as applicable; and 29 CFR part
1911.
Sections 1917.28 and 1917.31 also issued
under 5 U.S.C. 553.
Section 1917.29 also issued under 49
U.S.C. 1801–1819 and 5 U.S.C. 553.
Subpart B—Marine Terminal
Operations
■10. Add § 1917.31 to subpart B to read
as follows:
§ 1917.31
COVID–19.
The requirements applicable to
marine terminal work under this section
are identical to those set forth at 29 CFR
1910.501.
PART 1918—SAFETY AND HEALTH
REGULATIONS FOR LONGSHORING
■11. The authority citation for part
1918 is revised to read as follows:
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Authority: 33 U.S.C. 941; 29 U.S.C. 653,
655, 657; Secretary of Labor’s Order No. 12–
71 (36 FR 8754), 8–76 (41 FR 25059), 9–83
(48 FR 35736), 1–90 (55 FR 9033), 6–96 (62
FR 111), 3–2000 (65 FR 50017), 5–2002 (67
FR 65008), 5–2007 (72 FR 31160), 4–2010 (75
FR 55355), 1–2012 (77 FR 3912), or 8–2020
(85 FR 58393), as applicable; and 29 CFR
1911.
Sections 1918.90 and 1918.110 also issued
under 5 U.S.C. 553.
Section 1918.100 also issued under 49
U.S.C. 5101 et seq. and 5 U.S.C. 553.
■12. Add subpart K to part 1918 to read
as follows:
Subpart K—COVID–19.
Sec.
1918.107–1918.109
[Reserved]
1918.110
COVID–19.
1918.107 through 1918.109
[Reserved]
§ 1918.110
COVID–19.
The requirements applicable to
longshoring work under this section are
identical to those set forth at 29 CFR
1910.501.
PART 1926—SAFETY AND HEALTH
REGULATIONS FOR CONSTRUCTION
■13. The authority citation for part
1926 is revised to read as follows:
Authority: 40 U.S.C. 3704; 29 U.S.C. 653,
655, and 657; and Secretary of Labor’s Order
No. 12–71 (36 FR 8754), 8–76 (41 FR 25059),
9–83 (48 FR 35736), 1–90 (55 FR 9033), 6–
96 (62 FR 111), 3–2000 (65 FR 50017), 5–
2002 (67 FR 65008), 5–2007 (72 FR 31159),
4–2010 (75 FR 55355), 1–2012 (77 FR 3912),
or 8–2020 (85 FR 58393), as applicable; and
29 CFR part 1911.
Sections 1926.58, 1926.59, 1926.60, and
1926.65 also issued under 5 U.S.C. 553 and
29 CFR part 1911.
Section 1926.61 also issued under 49
U.S.C. 1801–1819 and 5 U.S.C. 553.
Section 1926.62 also issued under sec.
1031, Public Law 102–550, 106 Stat. 3672 (42
U.S.C. 4853).
Section 1926.65 also issued under sec. 126,
Public Law 99–499, 100 Stat. 1614 (reprinted
at 29 U.S.C.A. 655 Note) and 5 U.S.C. 553.
Subpart D—Occupational Health and
Environmental Controls
■14. Add § 1926.58 to read as follows:
§ 1926.58
COVID–19.
The requirements applicable to
construction work under this section are
identical to those set forth at 29 CFR
1910.501 Subpart U.
PART 1928—OCCUPATIONAL SAFETY
AND HEALTH STANDARDS FOR
AGRICULTURE
■15. The authority citation for part
1928 is revised to read as follows:
Authority: Sections 4, 6, and 8 of the
Occupational Safety and Health Act of 1970
(29 U.S.C. 653, 655, 657); Secretary of Labor’s
Order No. 12–71 (36 FR 8754), 8–76 (41 FR
25059), 9–83 (48 FR 35736), 1–90 (55 FR
9033), 6–96 (62 FR 111), 3–2000 (65 FR
50017), 5–2002 (67 FR 65008), 4–2010 (75 FR
55355), or 8–2020 (85 FR 58393), as
applicable; and 29 CFR 1911.
Section 1928.21 also issued under 49
U.S.C. 1801–1819 and 5 U.S.C. 553.
Subpart B—Applicability of Standards
■16. Amend § 1928.21 by adding
paragraph (a)(8) to read as follows:
§ 1928.21
Applicable standards in 29 CFR
part 1910.
(a) * * *
(8) COVID–19—§ 1910.501, but only
with respect to—
(i) Agricultural establishments where
eleven (11) or more employees are
engaged on any given day in hand-labor
operations in the field; and
(ii) Agricultural establishments that
maintain a temporary labor camp,
regardless of how many employees are
engaged on any given day in hand-labor
operations in the field.
*
*
*
*
*
[FR Doc. 2021–23643 Filed 11–4–21; 8:45 am]
BILLING CODE 4510–26–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 416, 418, 441, 460, 482,
483, 484, 485, 486, 491 and 494
[CMS–3415–IFC]
RIN 0938–AU75
Medicare and Medicaid Programs;
Omnibus COVID–19 Health Care Staff
Vaccination
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment
period.
SUMMARY: This interim final rule with
comment period revises the
requirements that most Medicare- and
Medicaid-certified providers and
suppliers must meet to participate in the
Medicare and Medicaid programs.
These changes are necessary to help
protect the health and safety of
residents, clients, patients, PACE
participants, and staff, and reflect
lessons learned to date as a result of the
COVID–19 public health emergency.
The revisions to the requirements
establish COVID–19 vaccination
requirements for staff at the included
Medicare- and Medicaid-certified
providers and suppliers.
DATES:
Effective date: These regulations are
effective on November 5, 2021.
Implementation dates: The
regulations included in Phase 1 [42 CFR
416.51(c) through (c)(3)(i) and (c)(3)(iii)
through (x), 418.60(d) through (d)(3)(i)
and (d)(3)(iii) through (x), 441.151(c)
through (c)(3)(i) and (c)(3)(iii) through
(x), 460.74(d) through (d)(3)(i) and
(d)(3)(iii) through (x), 482.42(g) through
(g)(3)(i) and (g)(3)(iii) through (x),
483.80(d)(3)(v) and 483.80(i) through
(i)(3)(i) and (i)(3)(iii) through (x),
483.430(f) through (f)(3)(i) and (f)(3)(iii)
through (x), 483.460(a)(4)(v), 484.70(d)
through (d)(3)(i) and (d)(3)(iii) through
(x), 485.58(d)(4), 485.70(n) through
(n)(3)(i) and (n)(3)(iii) through (x),
485.640(f) through (f)(3)(i) and (f)(3)(iii)
through (x), 485.725(f) through (f)(3)(i)
through (f)(3)(iii) through (x), 485.904(c)
through (c)(3)(i) and (c)(3)(iii) through
(x), 486.525(c) through (c)(3)(i) and
(c)(3)(iii) through (x), 491.8(d) through
(d)(3)(i) and (d)(3)(iii) through (x),
494.30(b) through (b)((3)(i) and (b)(3)(iii)
through (x) must be implemented by
December 6, 2021.
The regulations included in Phase 2
[42 CFR 416.51(c)(3)(ii), 418.60(d)(3)(ii),
441.151(c)(3)(ii), 460.74(d)(3)(ii),
482.42(g)(3)(ii), 483.80(i)(3)(ii),
483.430(f)(3)(ii), 484.70(d)(3)(ii),
485.70(n)(3)(ii), 485.640(f)(3)(ii),
485.725(f)(3)(ii), 485.904(c)(3)(ii),
486.525(c)(3)(ii), 491.8(d)(3)(ii),
494.30(b)(3)(ii)] must be implemented
by January 4, 2022. Staff who have
completed a primary vaccination series
by this date are considered to have met
these requirements, even if they have
not yet completed the 14-day waiting
period required for full vaccination.
Comment date: To be assured
consideration, comments must be
received at one of the addresses
provided below, no later than 5 p.m. on
January 4, 2022.
ADDRESSES: In commenting, please refer
to file code CMS–3415–IFC.
Comments, including mass comment
submissions, must be submitted in one
of the following three ways (please
choose only one of the ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to http://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–3415–IFC, P.O. Box 8016,
Baltimore, MD 21244–8016.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
VerDate Sep<11>2014
22:27 Nov 04, 2021
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Frm 00155
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No. A-____
_________________________

IN THE SUPREME COURT OF THE UNITED STATES
_________________________

IN RE: MCP NO. 165, OCCUPATIONAL SAFETY AND HEALTH
ADMINISTRATION, INTERIM FINAL RULE: COVID-19 VACCINATION AND
TESTING; EMERGENCY TEMPORARY STANDARD 86 FED. REG. 61402.

JOB CREATORS NETWORK, INDEPENDENT BAKERS ASSOCIATION,
LAWRENCE TRANSPORTATION COMPANY, GUY CHEMICAL COMPANY,
RABINE GROUP OF COMPANIES, PAN-O-GOLD BAKING COMPANY, TERRI
MITCHELL, WATERBLASTING, LLC,

Applicants,
v.

Respondents.
_________________________

CERTIFICATE OF SERVICE

I, Jonathan Berry, hereby certify that I am a member of the Bar of this Court,
and that I will cause the Emergency Application for Stay of Agency Standard
Pending the Disposition by the United States Court of Appeals for the Sixth
Circuit of a Petition for Review and Any Further Proceedings in This Court to be
served via first-class mail postage pre-paid to:

Ms. Elizabeth Prelogar
U.S. Department of Justice
950 Pennsylvania Avenue, N.W.
Washington, DC 20530

Mr. Aaron Abadi
82 Nassau Street
Apartment 140
New York, NY 10038

Mr. Robert Alt
The Buckeye Institute
88 E. Broad Street
Suite 1300
Columbus, OH 43215

Mr. Michael Timothy Anderson
Murphy Anderson
1401 K Street, N.W.
Suite 300
Washington, DC 20005

Mr. Edmund Charles Baird
U.S. Department of Labor
Office of the Solicitor
200 Constitution Avenue, N.W.
Suite S-4004
Washington, DC 20210

Mr. Ryan Bangert
Alliance Defending Freedom
15100 N. 90th Street
Scottsdale, AZ 85260

Mr. David Joseph Beck
Beck Redden
1221 McKinney Street
Suite 4500
Houston, TX 77010

Mr. Craig Becker
Office of the General Counsel
815 16th Street, N.W.
6th Floor
Washington, DC 20006

Mr. Josh Belinfante
Robbins Ross Alloy Belinfante Littlefield
500 14th Street, N.W.
Atlanta, GA 30318

Mr. Ross Warren Bergethon
Office of the Attorney General

3
of Georgia
40 Capitol Square, S.W.
Atlanta, GA 30334

Ms. Nicole G. Berner
Service Employees International Union
1800 Massachusetts Avenue, N.W.
Washington, DC 20036

Mr. Keith R. Bolek
O'Donoghue & O'Donoghue
5301 Wisconsin Avenue, N.W.
Suite 800
Washington, DC 20015

Ms. Victoria Louise Bor
Sherman, Dunn, Cohen, Leifer & Yellig
900 Seventh Street, N.W.
Suite 1000
Washington, DC 20001

Mr. Matthew Scott Bowman
Alliance Defending Freedom
440 First Street, N.W.
Suite 600
Washington, DC 20001

Mr. Charles Edmond Brasington
Department of Law
State of Alaska
1031 W. 4th Avenue
Suite 200
Anchorage, AK 99501

Mr. Adam C. Breihan
Murphy Anderson
1401 K Street, N.W.
Suite 300
Washington, DC 20005

Mr. Nicholas J. Bronni
Office of the Attorney General
of Arkansas
323 Center Street

4
Suite 200
Little Rock, AR 72201-2610

James A. Campbell
Office of the Attorney General
of Nebraska
2115 State Capitol
Lincoln, NE 68509-8920

Mr. John Stone Campbell III
Taylor, Porter, Brooks & Phillips
P.O. Box 2471
Baton Rouge, LA 70801

Mr. Joshua Joseph Campbell
America First Policy Institute
1001 Pennsylvania Avenue, N.W.
Suite 350
Washington, DC 20004

Mr. Jeffrey A. Chanay
Office of the Attorney General
of Kansas
120 S.W. 10th Avenue
Second Floor
301
Topeka, KS 66612-1597

Mr. Matthew James Clark
Alabama Center for Law and Liberty
2213 Morris Avenue
Floor 1
Birmingham, AL 35203

Mr. John V. Coghlan
Office of the Attorney General
for Mississippi
550 High Street
Jackson, MS 20043

Mr. David Andrew Cortman
Alliance Defending Freedom
1000 Hurricane Shoals Road, N.E.
Suite D-1100

5
Lawrenceville, GA 30043

Mr. Nate Curtisi
Texas Public Policy Foundation
901 Congress Avenue
Austin, TX 78701

Ms. Sylvia May Davis
Office of the Attorney General
of Ohio
615 W. Superior Avenue
11th Floor
Cleveland, OH 44113

Mr. David M.S. Dewhirst
Office of the Attorney General
of Montana
P.O. Box 201401
Helena, MT 59620-1401

Ms. Harmeet Dhillon
Dhillon Law Group
177 Post Street
Suite 700
San Francisco, CA 94108

Mr. Buck Dougherty
Liberty Justice Center
141 W. Jackson Street
Suite 1605
Chicago, IL 60603

Mr. Jefferson Downing
Keating & O'Gara
P.O. Box 82248
Lincoln, NE 68501-2248

Mr. Jeffrey B. Dubner
Democracy Forward Foundation
P.O. Box 34553
Washington, DC 20043

Mr. Jeremy Dys
First Liberty Institute

6
2001 W. Plano Parkway
Suite 1600
Plano, TX 75075

Mr. Steven R. Eatherly
Butzel Long
150 W. Jefferson Avenue
Suite 100
Detroit, MI 48226

Mr. Drew Curtis Ensign
Office of the Attorney General
State of Arizona
2005 N. Central Avenue
Phoenix, AZ 85004

Mr. Thomas Molnar Fisher
Office of the Attorney General
of Indiana
302 W. Washington Street
Fifth Floor
Indianapolis, IN 46204

Mr. Charles Flores
Beck Redden
1221 McKinney Street
Suite 4500
Houston, TX 77010

Mr. Benjamin Michael Flowers
Office of the Attorney General
30 E. Broad Street
14th Floor
Columbus, OH 43215

Mr. Peter Ford
United Food & Commercial Workers International Union
1775 K Street, N.W.
Suite 700
Washington, DC 20006-1598

Mr. Anthony J. Galdieri
Office of the Attorney General
of New Hampshire

7
33 Capitol Street
Concord, NH 03301

Mr. Thomas P. Gies
Crowell & Moring
1001 Pennsylvania Avenue, N.W.
8th Floor
Washington, DC 20004

Ms. Brianne Jenna Gorod
Constitutional Accountability Center
1200 18th Street, N.W.
Suite 501
Washington, DC 20036

Mr. Stanley M. Gosch
Rosenblatt & Gosch
8085 E. Prentice Avenue
Greenwood Village, CO 80111

Ms. Shannon Marie Grammel
Office of the Attorney General
of Kansas
120 S.W. 10th Avenue
Second Floor
Topeka, KS 66612-1597

Mr. Grant Joseph Guillot
Law Office
5028 River Meadow Drive
Baton Rouge, LA 70820

Mr. Deepak Gupta
Law Office
1900 L. Street, N.W.
Suite 312
Washington, DC 20036

Ms. Sarah Harbison
Pelican Institute for Public Policy
400 Poydras Street
Suite 900
New Orleans, LA 70130

Ms. Leslie Hayes
Office of the Attorney General of Idaho
Civil Litigation
P.O. Box 83720
Boise, ID 83720-0010

Mr. Ryan Lawrence Heath
Gavel Project
4022 E. Greenway Road
Suite 11 - 139
Phoenix, AZ 85032

Mr. Clark Lassiter Hildabrand
Office of the Attorney General
of Tennessee
P.O. Box 20207
Nashville, TN 37202-0207

Ms. Melissa Ann Holyoak
Office of the Attorney General
of Utah
160 E. 300 South
Fifth Floor
Salt Lake City, UT 84114-0857

Mr. Thomas T. Hydrick
Office of the Attorney General
of South Carolina
P.O. Box 11549
Columbia, SC 29211

Mr. Thomas M. Johnson Jr.
Wiley Rein
2050 M Street, N.W.
Washington, DC 20006

Mr. Brian Patrick Kane
Office of the Attorney General of Idaho
Civil Litigation
P.O. Box 83720
Boise, ID 83720-0010

Ms. Lindsey Keiser

9
Office of the Attorney General
of Kentucky
700 Capital Avenue
Suite 118
Frankfort, KY 40601

Mr. Scott Allen Keller
Lehotsky Keller
200 Massachusetts Avenue, N.W.
Washington, DC 20001

Ms. Ashley Steiner Kelly
Arnall Golden Gregory
171 17th Street, N.W.
Suite 2100
Atlanta, GA 30363

Mr. Kris W. Kobach
Alliance for Free Citizens
P.O. Box 155
Lecompton, KS 66050

Mr. Edmund Gerard LaCour Jr.
Office of the Attorney General
P.O. Box 300152
Montgomery, AL 36130-0152

Mr. Samuel Paul Langholz
Office of the Attorney General
of Iowa
1305 E. Walnut Street
Second Floor
Des Moines, IA 50319

Ms. Megan Ann Larrondo
Office of the Attorney General of Idaho
Civil Litigation
P.O. Box 83720
Boise, ID 83720-0010

Mr. Daniel P. Lennington
Wisconsin Institute for Law and Liberty
330 E. Kilbourn Aveue
Suite 725

10
Milwaukee, WI 53202

Ms. Emmy L. Levens
Cohen, Milstein, Sellers & Toll
1100 New York Avenue, N.W.
Suite 500-W
Washington, DC 20005

Mr. Sheng Tao Li
New Civil Liberties Alliance
1225 19th Street, N.W.
Suite 450
Washington, DC 20036

Mr. Mithun Mansinghani
Office of the Attorney General
of Oklahoma
313 N.E. 21st Street
Oklahoma City, OK 73105

Ms. Cathleen A. Martin
Newman, Comley & Ruth
P.O. Box 537
Suite 301
Jefferson City, MO 65102

Mr. David M. McVey
Office of the Attorney General
of South Dakota
1302 E. Highway 14
Suite 1
Pierre, SD 57501-4106

Mr. Matthew W. Murphy
Vessell Bridges Murphy Law Offices
3901 S. Providence Road
Suite D
Columbia, MO 65203

Ms. Elizabeth B. Murrill
Office of the Attorney General
of Louisiana
P.O. Box 94005
Baton Rouge, LA 70804-9005

Mr. John Parham Murrill
Taylor, Porter, Brooks & Phillips
P.O. Box 2471
Baton Rouge, LA 70801

Mr. William G. Myers III
Holland & Hart LLP
P.O. Box 2527
Boise, ID 83701

Mr. Scott Lawrence Nelson
Public Citizen Litigation Group
1600 Twentieth Street, N.W.
Washington, DC 20009

Mr. Russell A. Newman
Law Office
6688 Nolensville Road
Suite 108-22
Brentwood, TN 37075

Mr. Richard J. Oparil
Law Office
1775 Pennsylvania Avenue, N.W.
Suite 1000
Washington, DC 20006-0000

Mr. Henry M. Perlowski
Arnall Golden Gregory
171 17th Street, N.W.
Suite 2100
Atlanta, GA 30363

Mr. Javier Pico-Prats
Robbins Ross Alloy Belinfante Littlefield
500 14th Street, N.W.
Atlanta, GA 30318

Mr. David Andrew Porter
Kienbaum, Hardy, Viviano, Pelton & Forrest
280 N. Old Woodward Avenue
Suite 400
Birmingham, MI 48009

Ms. Randy Sue Rabinowitz
Law Office
P.O. Box 3769
Washington, DC 20027

Mr. Aaron Randall Rice
Mississippi Justice Institute
520 George Street
Jackson, MS 39202

Mr. Joseph E. Richotte
Butzel Long
201 W. Big Beaver Road
Suite 1200
Troy, MI 48084

Ms. Amy L. Rosenberger
Willig, Williams & Davidson
1845 Walnut Street
24th Floor
Philadelphia, PA 19103

Mr. David A. Rosenfeld
Weinberg, Roger & Rosenfeld
1375 55th Street
Emeryville, CA 94608

Mr. Scott E. Rosenow
WMC Litigaton Center
501 E. Washington Avenue
Madison, WI 53703

Mr. Andrew Dean Roth
Bredhoff & Kaiser
805 Fifteenth Street, N.W.
Suite 1000
Washington, DC 20005

Mr. John A. Ruth
Newman, Comley & Ruth
P.O. Box 537
Jefferson City, MO 65102

13
Mr. Matthew A. Sagsveen
Office of the Attorney General
of North Dakota
500 N. Ninth Street
Bismarck, ND 58501

Mr. Dean John Sauer
Office of the Attorney General
of Missouri
P.O. Box 899
Jefferson City, MO 65102

Mr. Ryan T. Schelhaas
Office of the Attorney General
of Wyoming
109 State Capitol
Cheyenne, WY 82002

Ms. Lindsay Sara See
Office of the Attorney General
of West Virginia
State Capitol Complex
Building 1, Room E-26
Charleston, WV 25305

Mr. Jordan A. Sekulow
American Center for Law and Justice
201 Maryland Avenue, N.E.
Washington, DC 20002

Mr. Brandon James Smith
Office of the Attorney General
of Tennessee
P.O. Box 20207
Nashville, TN 37202-0207

Mr. James Larry Stine
Wimberly Lawson
3400 Peachtree Road, NE
Suite 400
Atlanta, GA 30326

Mr. Judd Edward Stone II
Office of the Attorney General

14
Solicitor General Division
209 W. 14th Street
Seventh Floor (MC 059)
Austin, TX 78681

Ms. Catherine L. Strauss
Ice Miller
250 West Street
Suite 700
Columbus, OH 43215

Mr. Patrick Strawbridge
Consovoy McCarthy
10 Post Office Square
Eighth Floor South, PMB 706
Boston, MA 02109

Mr. Daniel Robert Suhr
Liberty Justice Center
141 W. Jackson Street
Suite 1605
Chicago, IL 60603

Mr. James Patrick Sullivan
Office of the Governor
of Texas
1100 San Jacinto Boulevard
Fourth Floor
Austin, TX 78701

Mr. Christopher L. Thacker
Office of the Attorney General
of Kentucky
700 Capitol Avenue
Suite 118
Frankfort, KY 40601

Mr. Halron Waites Turner
Turner Onderdonk Kimbrough Howell Huggins & Bradley
P.O. Box 1389
Chatom, AL 36518

Mr. Vincent M. Wagner
Office of the Attorney General

15
of Arkansas
323 Center Street
Suite 200
Little Rock, AR 72201-2610

Mr. Thomas J. Ward
National Association of Home Builders
1201 15th Street, N.W.
Washington, DC 20005

Mr. Henry Charles Whitaker
Office of the Attorney General
of Florida
The Capitol, PL-01
Tallahassee, FL 32399-1050

Mr. Christopher David Wiest
Law Office
25 Town Center Boulevard
Suite 104
Crestview Hills, KY 41017

Mr. Kurtis T. Wilder
Butzel Long
150 W. Jefferson Avenue
Suite 100
Detroit, MI 48226

Ms. Allison M. Zieve
Public Citizen Litigation Group
1600 Twentieth Street, N.W.
Washington, DC 20009

By _________________________________
Jonathan Berry
Counsel of Record

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Emergency Application for Stay — In re MCP No. 165 (OSHA ETS)

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