Court filing
Appendix — OSHA COVID-19 Vaccination and Testing Emergency Temporary Standard, No. 21A244
Summary
An appendix, No. 21A244, that opens with the Federal Register of Friday, November 5, 2021, and the Occupational Safety and Health Administration interim final rule COVID–19 Vaccination and Testing; Emergency Temporary Standard. The printed summary says 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, and that the rule is effective November 5, 2021. The closing pages come from a document in Case: 21-7000, In re: MCP No. 165, and state that the Secretary likely lacks congressional authority to force the unvaccinated to protect themselves.
Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used
Cite this document
“Appendix — OSHA COVID-19 Vaccination and Testing Emergency Temporary Standard, No. 21A244.”
Original at www.supremecourt.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/court-filings/scotus/undated-order-21a244-002-dec-17-2021-lower-court-ordersopinions-20211217194601996-appendix-opinions-pdfa/
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Appendix 1
App. 1
61402 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
DEPARTMENT OF LABOR electronically at www.regulations.gov, A. Executive Summary
which is the Federal e-Rulemaking B. Request for Comment
Occupational Safety and Health Portal. Follow the online instructions II. Pertinent Legal Authority
Administration for making electronic submissions. III. Rationale for the ETS
A. Grave Danger
Instructions: All submissions must B. Need for the ETS
29 CFR Parts 1910, 1915, 1917, 1918, include the agency’s name and the IV. Feasibility
1926, and 1928 docket number for this rulemaking A. Technological Feasibility
[Docket No. OSHA–2021–0007] (Docket No. OSHA–2021–0007). All B. Economic Analysis
comments, including any personal V. Additional Requirements
RIN 1218–AD42 information you provide, are placed in VI. Summary and Explanation
the public docket without change and A. Purpose
COVID–19 Vaccination and Testing; may be made available online at B. Scope and Application
Emergency Temporary Standard www.regulations.gov. Therefore, OSHA C. Definitions
D. Employer Policy on Vaccination
AGENCY: Occupational Safety and Health cautions commenters about submitting E. Determination of Employee Vaccination
Administration (OSHA), Department of information they do not want made Status
Labor. available to the public, or submitting F. Employer Support for Employee
ACTION: Interim final rule; request for materials that contain personal Vaccination
comments. information (either about themselves or G. COVID–19 Testing for Employees Who
others), such as Social Security Are Not Fully Vaccinated
SUMMARY: The Occupational Safety and Numbers and birthdates. H. Employee Notification to Employer of a
Health Administration (OSHA) is Docket: To read or download Positive COVID–19 Test and Removal
issuing an emergency temporary comments or other material in the I. Face Coverings
J. Information Provided to Employees
standard (ETS) to protect unvaccinated docket, go to Docket No. OSHA–2021– K. Reporting COVID–19 Fatalities and
employees of large employers (100 or 0007 at www.regulations.gov. All Hospitalizations to OSHA
more employees) from the risk of comments and submissions are listed in L. Availability of Records
contracting COVID–19 by strongly the www.regulations.gov index; M. Dates
encouraging vaccination. Covered however, some information (e.g., N. Severability
employers must develop, implement, copyrighted material) is not publicly O. Incorporation by Reference
and enforce a mandatory COVID–19 available to read or download through VII. Authority and Signature
vaccination policy, with an exception that website. All comments and I. Executive Summary and Request for
for employers that instead adopt a submissions, including copyrighted Comment
policy requiring employees to either get material, are available for inspection
vaccinated or elect to undergo regular through the OSHA Docket Office. A. Executive Summary
COVID–19 testing and wear a face Documents submitted to the docket by This ETS is based on the requirements
covering at work in lieu of vaccination. OSHA or stakeholders are assigned of the Occupational Safety and Health
DATES: The rule is effective November 5, document identification numbers Act (OSH Act or Act) and legal
2021. The incorporation by reference of (Document ID) for easy identification precedent arising under the Act. Under
certain publications listed in the rule is and retrieval. The full Document ID is section 6(c)(1) of the OSH Act, 29 U.S.C.
approved by the Director of the Federal the docket number plus a unique four- 655(c)(1), OSHA shall issue an ETS if
Register as of November 5, 2021. digit code. OSHA is identifying the agency determines that employees
Compliance dates: Compliance dates supporting information in this ETS by are subject to grave danger from
for specific provisions are in 29 CFR author name and publication year, when exposure to substances or agents
1910.501(m). appropriate. This information can be determined to be toxic or physically
Comments: Written comments, used to search for a supporting harmful or from new hazards, and an
including comments on any aspect of document in the docket at http:// ETS is necessary to protect employees
this ETS and whether this ETS should www.regulations.gov. Contact the OSHA from such danger. These legal
become a final rule, must be submitted Docket Office at 202–693–2350 (TTY requirements are more fully discussed
by December 6, 2021 in Docket No. number: 877–889–5627) for assistance in Pertinent Legal Authority (Section II.
OSHA–2021–0007. Comments on the in locating docket submissions. of this preamble). This ETS does not
information collection determination FOR FURTHER INFORMATION CONTACT: apply to workplaces subject to E.O.
described in Additional Requirements General information and press 14042 on Requiring Coronavirus Disease
(Section V.K. of this preamble) (OMB inquiries: Contact Frank Meilinger, 2019 Vaccination for Federal
review under the Paperwork Reduction OSHA Office of Communications, U.S. Contractors. In addition, OSHA will
Act of 1995) may be submitted by Department of Labor; telephone (202) treat federal agencies’ compliance with
January 4, 2022 in Docket No. OSHA– 693–1999; email OSHAComms@dol.gov. E.O. 14043, and the Safer Federal
2021–0008. For technical inquiries: Contact Workforce Task Force guidance issued
ADDRESSES: In accordance with 28 Andrew Levinson, OSHA Directorate of under section 4(e) of Executive Order
U.S.C. 2112(a), the Agency designates Standards and Guidance, U.S. 13991 and section 2 of Executive Order
Edmund C. Baird, the Associate Department of Labor; telephone (202) 14043, as sufficient to meet their
Solicitor for Occupational Safety and 693–1950; email ETS@dol.gov. obligations under the OSH Act and E.O.
Health, Office of the Solicitor, U.S. SUPPLEMENTARY INFORMATION: The 12196.
Department of Labor, to receive preamble to the ETS on COVID–19 COVID–19 has killed over 725,000
petitions for review of the ETS. Service vaccination and testing follows this people in the United States in less than
can be accomplished by email to zzSOL- outline: two years, and infected millions more
Covid19-ETS@dol.gov. (CDC, October 18, 2021—Cumulative
Written comments. You may submit Table of Contents US Deaths). The pandemic continues to
comments and attachments, identified I. Executive Summary and Request for affect workers and workplaces. While
by Docket No. OSHA–2021–0007, Comment COVID–19 vaccines authorized or
App. 2
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61403
approved by the U.S. Food and Drug time the standard is in effect. In light of of the ETS to address smaller employers
Administration (FDA) effectively protect the unique occupational safety and in the future. OSHA seeks information
vaccinated individuals against severe health dangers presented by COVID–19, about the ability of employers with
illness and death from COVID–19, and against the backdrop of the fewer than 100 employees to implement
unvaccinated individuals remain at uncertain economic environment of a COVID–19 vaccination and/or testing
much higher risk of severe health pandemic, OSHA is proceeding in a programs. Have you instituted
outcomes from COVID–19. Further, stepwise fashion in addressing the vaccination mandates (with or without
unvaccinated workers are much more emergency this rule covers. OSHA is alternatives), or requirements for regular
likely to contract and transmit COVID– confident that employers with 100 or COVID–19 testing or face covering use?
19 in the workplace than vaccinated more employees have the administrative What have been the benefits of your
workers. OSHA has determined that capacity to implement the standard’s approach? What challenges have you
many employees in the U.S. who are not requirements promptly, but is less had or could you foresee in
fully vaccinated against COVID–19 face confident that smaller employers can do implementing such programs? Is there
grave danger from exposure to SARS– so without undue disruption. OSHA anything specific to your industry, or
CoV–2 in the workplace. This finding of needs additional time to assess the the size of your business, that poses
grave danger is based on the severe capacity of smaller employers, and is particular obstacles in implementing the
health consequences associated with seeking comment to help the agency requirements in this standard? How
exposure to the virus along with make that determination. Nonetheless, much time would it take, what types of
evidence demonstrating the the agency is acting to protect workers costs would you incur, and how much
transmissibility of the virus in the now in adopting a standard that will would it cost for you to implement such
workplace and the prevalence of reach two-thirds of all private-sector requirements?
infections in employee populations, as workers in the nation, including those 2. Significant Risk. If OSHA were to
discussed in Grave Danger (Section working in the largest facilities, where finalize a rule based on this ETS, it
III.A. of this preamble). the most deadly outbreaks of COVID–19 would be a standard adopted under 6(b)
OSHA has also determined that an can occur. of the OSH Act, which requires a
ETS is necessary to protect The agency has also evaluated the finding of significant risk from exposure
unvaccinated workers from the risk of feasibility of this ETS and has to COVID–19. As discussed more fully
contracting COVID–19 at work, as determined that the requirements of the in Pertinent Legal Authority (Section II.
discussed in Need for the ETS (Section ETS are both economically and of this preamble), this is a lower
III.B. of this preamble). At the present technologically feasible, as outlined in showing of risk than grave danger, the
time, workers are becoming seriously ill Feasibility (Section IV. of this finding required to issue a 6(c)
and dying as a result of occupational preamble). The specific requirements of emergency temporary standard. How
exposures to COVID–19, when a simple the ETS are outlined and described in should the scope of the rule change to
measure, vaccination, can largely Summary and Explanation (Section VI. address the significant risk posed by
prevent those deaths and illnesses. The of this preamble). COVID–19 in the workplace? Should
ETS protects these workers through the portions of the rule, such as face
B. Request for Comment
most effective and efficient control coverings, apply to fully vaccinated
available—vaccination—and further Although this ETS takes effect persons?
protects workers who remain immediately, it also serves as a proposal 3. Prior COVID–19 infections. OSHA
unvaccinated through required regular under Section 6(b) of the OSH Act (29 determined that workers who have been
testing, use of face coverings, and U.S.C. 655(b)) for a final standard. infected with COVID–19 but have not
removal of all infected employees from Accordingly, OSHA seeks comment on been fully vaccinated still face a grave
the workplace. OSHA also concludes, all aspects of this ETS and whether it danger from workplace exposure to
based on its enforcement experience should be adopted as a final standard. SARS–CoV–2. This is an area of ongoing
during the pandemic to date, that OSHA encourages commenters to scientific inquiry. Given scientific
continued reliance on existing standards explain why they prefer or disfavor uncertainty and limitations in testing for
and regulations, the General Duty particular policy choices, and include infection and immunity, OSHA is
Clause of the OSH Act, 29 U.S.C. any relevant studies, experiences, concerned that it would be infeasible for
654(a)(1), and workplace guidance, in anecdotes or other information that may employers to operationalize a standard
lieu of an ETS, is not adequate to protect help support the comment. In that would permit or require an
unvaccinated employees from the grave particular, OSHA seeks comments on exception from vaccination or testing
danger of being infected by, and the following topics: and face covering based on prior
suffering death or serious health 1. Employers with fewer than 100 infection with COVID–19. Is there
consequences from, COVID–19. employees. As noted above and fully additional scientific information on this
OSHA will continue to monitor trends discussed in the Summary and topic that OSHA should consider as it
in COVID–19 infections and death as Explanation for Scope and Application determines whether to proceed with a
more of the workforce and the general (Section VI.B. of this preamble), OSHA permanent rule?
population become fully vaccinated has implemented a 100-employee In particular, what scientific criteria
against COVID–19 and the pandemic threshold for the requirements of this can be used to determine whether a
continues to evolve. Where OSHA finds standard to focus the ETS on companies given employee is sufficiently protected
a grave danger from the virus no longer that OSHA is confident will have against reinfection? Are there any
exists for the covered workforce (or sufficient administrative systems in temporal limits associated with this
some portion thereof), or new place to comply quickly with the ETS. criteria to account for potential
information indicates a change in The agency is moving in a stepwise reductions in immunity over time? Do
measures necessary to address the grave fashion on the short timeline you require employees to provide
danger, OSHA will update this ETS, as necessitated by the danger presented by verification of infection with COVID–
appropriate. COVID–19 while soliciting stakeholder 19? If so, what kinds of verification do
This ETS applies to employers with a comment and additional information to you accept (i.e., PCR testing, antigen
total of 100 or more employees at any determine whether to adjust the scope testing, etc.)? What challenges have you
App. 3
61404 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
experienced, if any, in operationalizing experienced other difficulties in you attempted to employ but found
such an exception? implementing a testing and removal ineffective or infeasible? What are they?
4. Experience with COVID–19 scheme, including the length of time to Why did you conclude that they were
vaccination policies. Should OSHA obtain COVID–19 test results? Do you they ineffective or infeasible; for
impose a strict vaccination mandate offer paid leave for testing? example, are there particular aspects of
(i.e., all employers required to (b) How often have you detected and your workplace or industry that make
implement mandatory vaccination removed COVID–19 positive employees certain controls infeasible? Do you
policies as defined in this ETS) with no from the workplace under this policy? require both fully vaccinated and
alternative compliance option? OSHA Do you provide paid leave and job unvaccinated employees to comply with
seeks information on COVID–19 protection to employees you remove for these controls? Have you experienced a
vaccination policies that employers this reason? reduction in infection rates or outbreaks
have implemented to protect workers. If (c) Should OSHA require testing more since implementing these controls?
you have implemented a COVID–19 often than on a weekly basis? 8. Educational materials. Have you
vaccination policy: 6. Face coverings. As discussed in the implemented any policies or provided
(a) When did you implement it, and Summary and Explanation for Face any information that has been helpful in
what does your policy require? Was Coverings (Section VI.I. of this encouraging an employee to be
vaccination mandatory or voluntary preamble), ASTM released a vaccinated?
under the policy? Do you offer specification standard on February 15, 9. Feasibility and health impacts. Do
vaccinations on site? What costs 2021, to establish a national standard you have any experience or data that
associated with vaccination did you baseline for barrier face coverings would inform OSHA’s estimates in its
cover under the policy? What (ASTM F3502–21). Should OSHA economic feasibility analysis or any of
percentage of your workforce was require the use of face coverings the assumptions or estimates used in
vaccinated as a result? Do you offer paid meeting the ASTM F3502–21 standard OSHA’s identification of the number of
leave for receiving a vaccination? If instead of the face coverings specified hospitalizations prevented and lives
vaccination is mandatory, have by the ETS? If so, should OSHA also saved from its health impacts analysis
employees been resistant and if so what require that such face coverings meet (see OSHA, October 2021c)?
steps were required to enforce the the NIOSH Workplace Performance or
policy? Workplace Performance Plus criteria References
(b) How did you verify that employees (see CDC, September 23, 2021)? Are Centers for Disease Control and Prevention
were vaccinated? Are there other there particular workplace settings in (CDC). (2021, October 18). COVID Data
reliable means of vaccination which face coverings meeting one Tracker. https://covid.cdc.gov/covid-
verification not addressed by the ETS standard should be favored over data-tracker/. (CDC, October 18, 2021)
that should be included? Did you allow another? Are there alternative criteria Centers for Disease Control and Prevention
attestation where the employee could OSHA should consider for face (CDC). (2021, September 23). Types of
not find other proof, and if so, have you coverings instead of the F3502–21 Masks and Respirators. https://
standard or NIOSH Workplace www.cdc.gov/coronavirus/2019-ncov/
experienced any difficulties with this
prevent-getting-sick/types-of-masks.html.
approach? Have you experienced any Performance or Workplace Performance
(CDC, September 23, 2021)
issues with falsified records of Plus criteria? Is there sufficient capacity Occupational Safety and Health
vaccination, and if so, how did you deal to supply face coverings meeting Administration (OSHA). (2021c,
with them? F3502–01 and/or NIOSH Workplace October). Health Impacts of the COVID–
(c) Have you experienced a decrease Performance or Workplace Performance 19 Vaccination and Testing ETS. (OSHA,
in infection rates or outbreaks after Plus criteria to all employees covered by October 2021c)
implementing this policy? the ETS? What costs have you incurred
II. Pertinent Legal Authority
(d) If you have received any requests as part of supplying employees with
for reasonable accommodation from face coverings meeting the appropriate The purpose of the Occupational
vaccination, what strategies did you criteria? Safety and Health Act of 1970 (OSH
implement to address the 7. Other controls. This ETS requires Act), 29 U.S.C. 651 et seq., is ‘‘to assure
accommodation and ensure worker employees to either be fully vaccinated so far as possible every working man
safety (e.g., telework, working in against COVID–19 or be tested weekly and woman in the Nation safe and
isolation, regular testing and the use of and wear face coverings, based on the healthful working conditions and to
face coverings)? type of policy their employer adopts. It preserve our human resources.’’ 29
5. COVID–19 testing and removal. stops short of requiring the full suite of U.S.C. 651(b). To this end, Congress
OSHA seeks information on COVID–19 workplace controls against SARS–CoV– authorized the Secretary of Labor
testing and removal practices 2 transmission recommended by OSHA (Secretary) to promulgate and enforce
implemented to protect workers. and the CDC, including distancing, occupational safety and health
(a) Do you have a testing and removal barriers, ventilation, and sanitation. As standards under sections 6(b) and (c) of
policy in your workplace and, if so, OSHA explained in Need for the ETS the OSH Act.1 29 U.S.C. 655(b). These
what does it require? How often do you (Section III.B. of this preamble), OSHA provisions provide bases for issuing
require testing and what types of testing has determined that it needs more occupational safety and health
do you use (e.g., at-home tests, tests information before imposing these standards under the Act. Once OSHA
performed at laboratories, tests requirements on the entire scope of has established as a threshold matter
performed at your worksites)? What industries and employers covered by the that a health standard is necessary
costs have you incurred as part of your standard. OSHA is interested in hearing under section 6(b) or (c)—i.e., to reduce
testing and removal policies? Do you from employers about their experience
have difficulty in finding adequate in implementing a full suite of 1 The Secretary has delegated most of his duties
availability of tests? How often? Have workplace controls against COVID–19. under the OSH Act to the Assistant Secretary of
Labor for Occupational Safety and Health.
you experienced any issues with What measures have you taken to Secretary’s Order 08–2020, 85 FR 58393 (Sept. 18,
falsified test results, and if so, how did protect employees against COVID–19 in 2020). This section uses the terms Secretary and
you deal with them? Have you your workplace? Are there controls that OSHA interchangeably.
App. 4
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61405
a significant risk of material health (D.C. Cir. 1983). The determination of ‘reasonably necessary or appropriate’ ’’
impairment, or a grave danger to what exact level of risk constitutes a as required by the OSH Act’s definition
employee health—the Act gives the ‘‘grave danger’’ is a ‘‘policy of ‘‘occupational safety and health
Secretary ‘‘almost unlimited discretion consideration that belongs, in the first standard’’ in section 3(8)); see also
to devise means to achieve the instance, to the Agency.’’ Asbestos Info. Florida Peach Growers, 489 F.2d at 130
congressionally mandated goal’’ of Ass’n, 727 F.2d at 425 (accepting (recognizing that the promulgation of
protecting employee health, subject to OSHA’s determination that eighty lives any standard, including an ETS, must
the constraints of feasibility. See United at risk over six months was a grave account for its economic effect).
Steelworkers of Am. v. Marshall, 647 danger); Indus. Union Dep’t, AFL–CIO v. However, given that section 6(c) is
F.2d 1189, 1230 (D.C. Cir. 1981). A Am. Petroleum Inst., 448 U.S. 607, 655 aimed at enabling OSHA to protect
standard’s individual requirements need n.62 (1980). However, a ‘‘grave danger’’ workers in emergency situations, the
only be ‘‘reasonably related’’ to the represents a risk greater than the agency is not required to make a
purpose of ensuring a safe and healthful ‘‘significant risk’’ that OSHA must show feasibility showing with the same rigor
working environment. Id. at 1237, 1241; in order to promulgate a permanent as in ordinary section 6(b) rulemaking.
see also Forging Indus. Ass’n v. Sec’y of standard under section 6(b) of the OSH Asbestos Info. Ass’n, 727 F.2d at 424
Labor, 773 F.2d 1436, 1447 (4th Cir. Act, 29 U.S.C. 655(b). Int’l Union, n.18.
1985). OSHA’s authority to regulate United Auto., Aerospace, & Agr. On judicial review of an ETS, OSHA
employers is hedged by constitutional Implement Workers of Am., UAW v. is entitled to great deference on the
considerations and, pursuant to section Donovan, 590 F. Supp. 747, 755–56 determinations of grave danger and
4(b)(1) of the OSH Act, the regulations (D.D.C. 1984), adopted, 756 F.2d 162 necessity required under section 6(c)(1).
and enforcement policies of other (D.C. Cir. 1985); see also Indus. Union See, e.g., Pub. Citizen Health Research
federal agencies. See, e.g., Chao v. Dep’t, AFL–CIO, 448 U.S. at 640 n.45 Grp., 702 F.2d at 1156; Asbestos Info.
Mallard Bay Drilling, Inc., 534 U.S. 235, (noting the distinction between the Ass’n, 727 F.2d at 422 (judicial review
241 (2002). standard for risk findings in permanent of these legislative determinations
The OSH Act in section 6(c)(1) states standards and ETSs). requires deference to the agency); cf.
that the Secretary ‘‘shall’’ issue an In determining the type of health Am. Dental Ass’n v. Martin, 984 F.2d
emergency temporary standard (ETS) effects that may constitute a ‘‘grave 823, 831 (7th Cir. 1993) (‘‘the duty of a
upon a finding that the ETS is necessary danger’’ under the OSH Act, the Fifth reviewing court of generalist judges is
to address a grave danger to workers. Circuit emphasized ‘‘the danger of merely to patrol the boundary of
See 29 U.S.C. 655(c). In particular, the incurable, permanent, or fatal reasonableness’’). These determinations
Secretary shall provide, without regard consequences to workers, as opposed to are ‘‘essentially legislative and rooted in
to the requirements of chapter 5, title 5, easily curable and fleeting effects on inferences from complex scientific and
United States Code, for an emergency their health.’’ Fla. Peach Growers Ass’n, factual data.’’ Pub. Citizen Health
temporary standard to take immediate Inc. v. U. S. Dep’t of Labor, 489 F.2d Research Grp., 702 F.2d at 1156. The
effect upon publication in the Federal 120, 132 (5th Cir. 1974). Although the agency is not required to support its
Register if the Secretary makes two findings of grave danger and necessity conclusions ‘‘with anything
determinations: That employees are must be based on evidence of ‘‘actual, approaching scientific certainty,’’ Indus.
exposed to grave danger from exposure prevailing industrial conditions,’’ see Union Dep’t, AFL–CIO, 448 U.S. at 656,
to substances or agents determined to be Int’l Union, 590 F. Supp. at 751, when and has the ‘‘prerogative to choose
toxic or physically harmful or from new OSHA determines that exposure to a between conflicting evidence.’’ Asbestos
hazards, and that such emergency particular hazard would pose a grave Info. Ass’n, 727 F.2d at 425.
standard is necessary to protect danger to workers, OSHA can assume an The determinations of the Secretary in
employees from such danger. 29 U.S.C. exposure to a grave danger wherever issuing standards under section 6 of the
655(c)(1). A separate section of the OSH that hazard is present in a workplace. OSH Act, including ETSs, must be
Act, section 8(c), authorizes the Dry Color Mfrs. Ass’n, Inc. v. Dep’t of affirmed if supported by ‘‘substantial
Secretary to prescribe regulations Labor, 486 F.2d 98, 102 n.3 (3d Cir. evidence in the record considered as a
requiring employers to make, keep, and 1973). whole.’’ 29 U.S.C. 655(f). The Supreme
preserve records that are necessary or In demonstrating whether OSHA had Court described substantial evidence as
appropriate for the enforcement of the shown that an ETS is necessary, the ‘‘such relevant evidence as a reasonable
Act. 29 U.S.C. 657(c)(1). Section 8(c) Fifth Circuit considered whether OSHA mind might accept as adequate to
also provides that the Secretary shall had another available means of support a conclusion.’’ Am. Textile
require employers to keep records of, addressing the risk that would not Mfrs. Inst., 452 U.S. at 522–23 (quoting
and report, work-related deaths and require an ETS. Asbestos Info. Ass’n, Universal Camera Corp. v. NLRB, 340
illnesses. 29 U.S.C. 657(c)(2). 727 F.2d at 426 (holding that necessity U.S. 474, 477 (1951)). The Court also
The ETS provision, section 6(c)(1), had not been proven where OSHA could noted that ‘‘the possibility of drawing
exempts the Secretary from procedural have increased enforcement of already- two inconsistent conclusions from the
requirements contained in the OSH Act existing standards to address the grave evidence does not prevent an
and the Administrative Procedure Act, risk to workers from asbestos exposure). administrative agency’s finding from
including those for public notice, Additionally, a standard must be both being supported by substantial
comments, and a rulemaking hearing. economically and technologically evidence.’’ Id. at 523 (quoting Consolo
See, e.g., 29 U.S.C. 655(b)(3); 5 U.S.C. feasible in order to be ‘‘reasonably v. FMC, 383 U.S. 607, 620 (1966)). The
552, 553. necessary and appropriate’’ under Fifth Circuit, recognizing the size and
The Secretary must issue an ETS in section 3(8) and, by inference, complexity of the rulemaking record
situations where employees are exposed ‘‘necessary’’ under section 6(c)(1)(B) of before it in the case of OSHA’s ETS for
to a ‘‘grave danger’’ and immediate the Act. Cf. Am. Textile Mfrs. Inst., Inc. organophosphorus pesticides, stated
action is necessary to protect those v. Donovan, 452 U.S. 490, 513 n.31 that a court’s function in reviewing an
employees from such danger. 29 U.S.C. (1981) (noting ‘‘any standard that was ETS to determine whether it meets the
655(c)(1); Pub. Citizen Health Research not economically or technologically substantial evidence standard is
Grp. v. Auchter, 702 F.2d 1150, 1156 feasible would a fortiori not be ‘‘basically [to] determine whether the
App. 5
61406 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
Secretary carried out his essentially standards pursuant to section 18 of the ‘‘the infectious character’’ of the
legislative task in a manner reasonable Act, which must be ‘‘at least as regulated bloodborne diseases might
under the state of the record before effective’’ as the Federal standards. 29 warrant ‘‘more regulation than would be
him.’’ Fla Peach Growers Ass’n, 489 U.S.C. 667; Indus. Truck Ass’n v. Henry, necessary in the case of a
F.2d at 129. 125 F.3d 1305, 1311 (9th Cir. 1997). noncommunicable disease.’’ 984 F.2d at
Although Congress waived the However, the OSH Act does not 826. In addition, in the preamble to the
ordinary rulemaking procedures in the preempt state laws of ‘‘general respiratory protection standard, 29 CFR
interest of ‘‘permitting rapid action to applicability’’ that regulate workers and 1910.134, which was also promulgated
meet emergencies,’’ section 6(e) of the non-workers alike, so long as they do under section 6(b)(5), ‘‘OSHA
OSH Act, 29 U.S.C. 655(e), requires not conflict with an OSHA standard. emphasize[d] that [the] respiratory
OSHA to include a statement of reasons Gade, 505 U.S. at 107. protection standard does apply to
for its action when it issues any As discussed in detail elsewhere in biological hazards.’’ Respiratory
standard. Dry Color Mfrs., 486 F.2d at this preamble, OSHA has determined Protection, 63 FR 1152–01, 1180 (Jan. 8,
105–06 (finding OSHA’s statement of that a grave danger exists necessitating 1998) (citing Mahone Grain Corp., 10
reasons inadequate). By requiring the a new ETS (see Grave Danger and Need BNA OSHC 1275 (No. 77–3041, 1981)).
agency to articulate its reasons for for the ETS, Sections III.A. and III.B. of In addition to being a physically
issuing an ETS, the requirement acts as this preamble), and that compliance harmful agent covered by section
‘‘an essential safeguard to emergency with this ETS is feasible for covered 6(c)(1)(A), SARS–CoV–2 is also, without
temporary standard-setting.’’ Id. at 106. employers (see Feasibility, Section IV. of question, a ‘‘new hazard’’ covered by
However, the Third Circuit noted that it this preamble). OSHA has also provided this provision, as discussed in more
did not require justification of ‘‘every a more detailed explanation of each detail in Grave Danger (Section III.A. of
substance, type of use or production provision of this ETS in Summary and this preamble). SARS–CoV–2 was not
technique,’’ but rather a ‘‘general Explanation (Section VI. of this known to exist until January 2020, and
explanation’’ of why the standard is preamble). In addition, OSHA wishes to since then more than 725,000 people
necessary. Id. at 107. provide here some general guidance on have died from COVID–19 in the U.S.
ETSs are, by design, temporary in its legal authority to regulate COVID–19 alone (CDC, October 18, 2021—
nature. Under section 6(c)(3), an ETS hazards, and for particular provisions of Cumulative US Deaths).
serves as a proposal for a permanent this ETS. Turning to specific provisions of this
standard in accordance with section 6(b) As a threshold matter, OSHA’s standard, the vaccination requirements
of the OSH Act (permanent standards), authority to regulate workplace in this ETS are also well within the
and the Act calls for the permanent exposure to biological hazards like bounds of OSHA’s authority.
standard to be finalized within six SARS–CoV–2 is well-established. Vaccination can be a critical tool in the
months after publication of the ETS. 29 Section 6(b)(5) of the OSH Act uses pursuit of health and safety goals,
U.S.C. 655(c)(3); see Fla. Peach Growers similar language to section 6(c)(1)(A): particularly in response to an infectious
Ass’n, 489 F.2d at 124. The ETS is The former sets forth requirements for and highly communicable disease. See,
effective ‘‘until superseded by a promulgating permanent standards e.g., Jacobson v. Commonwealth of
standard promulgated in accordance addressing ‘‘toxic materials or harmful Mass., 197 U.S. 11, 27–28 (1905)
with’’ section 6(c)(3). 29 U.S.C. physical agents,’’ and the latter (recognizing use of smallpox vaccine as
655(c)(2). authorizes OSHA to promulgate an ETS a reasonable measure to protect public
Section 6(c)(1) states that the addressing ‘‘substances or agents health and safety); Klaassen v. Trustees
Secretary ‘‘shall’’ provide for an ETS determined to be toxic or physically of Ind. Univ., 7 F.4th 592, 593 (7th Cir.
when OSHA makes the prerequisite harmful’’ (as well as ‘‘new hazards’’). 2021) (citing Jacobson and noting that
findings of grave danger and necessity. OSHA has consistently identified vaccination may be an appropriate
See Pub. Citizen Health Research Grp., biological hazards similar to SARS– safety measure against SARS–CoV–2 as
702 F.2d at 1156 (noting the mandatory CoV–2, as well as SARS–CoV–2 itself, to ‘‘[v]accination protects not only the
language of section 6(c)). OSHA is be ‘‘toxic materials or harmful physical vaccinated persons but also those who
entitled to great deference in its agents’’ under the Act. Indeed, in its come in contact with them’’). And the
determinations, and it must also exposure and medical records access OSH Act itself explicitly acknowledges
account for ‘‘the fact that ‘the interests regulation, OSHA has defined ‘‘toxic that such treatments might be necessary,
at stake are not merely economic materials or harmful physical agents’’ to in some circumstances. 29 U.S.C.
interests in a license or a rate structure, include ‘‘any . . . biological agent 669(a)(5) (providing in the Act’s
but personal interests in life and (bacteria, virus, fungus, etc.)’’ for which provisions on research and related
health.’ ’’ Id. (quoting Wellford v. there is evidence that it poses a chronic activities conducted by the Secretary of
Ruckelshaus, 439 F.2d 598, 601 (D.C. or acute health hazard. 29 CFR Health and Human Services to aid
Cir. 1971)). 1910.1020(c)(13). And in addition to OSHA in its formulation of health and
When OSHA issues a standard previously regulating exposure to safety standards that ‘‘[n]othing in this
pursuant to section 6—whether SARS–CoV–2 as a new and physically or any other provision of this Act shall
permanent or an ETS—section 18 of the harmful agent in the Healthcare ETS be deemed to authorize or require
OSH Act provides that OSHA’s standard (see, e.g., 86 FR at 32381), OSHA has medical examination, immunization, or
preempts any state occupational safety also previously regulated biological treatment for those who object thereto
or health standard ‘‘relating to [the hazards like SARS–CoV–2 as health on religious grounds, except where such
same] occupational safety or health hazards under section 6(b)(5), for is necessary for the protection of the
issue’’ as the Federal standard. 29 U.S.C. example in the Bloodborne Pathogens health or safety of others.’’ (emphasis
667(b); see also Gade v. Nat’l Solid (BBP) standard, 29 CFR 1910.1030, added)). In recognition of the health and
Wastes Mgmt. Ass’n, 505 U.S. 88, 97 which addresses workplace exposure to safety benefits provided by vaccination,
(1992). A state can avoid preemption HIV and Hepatitis B. The BBP standard OSHA has previously exercised its
only if it submits, and receives Federal was upheld (except as to application in authority to promulgate vaccine-related
approval for, a state plan for the certain limited industries) in American requirements in the COVID–19
development and enforcement of Dental Association, which observed that Healthcare ETS (29 CFR 1910.502(m))
App. 6
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61407
and the BBP standard (29 CFR OSHA only requires employers to bear the virus that causes COVID–19.3 OSHA
1910.1030(f)). The BBP standard the costs of employee compliance with has determined that occupational
illustrates congressional understanding the preferred, and more protective, exposure to SARS–CoV–2, including the
that the statutory delegation of authority vaccination provision, but not costs Delta variant (B.1.617.2 and AY
to OSHA to issue standards includes associated with testing. The agency does lineages), presents a grave danger to
authority for vaccine provisions, where not believe it appropriate to impose the unvaccinated workers in the U.S., with
appropriate. See Public Law 102–170, costs of testing on an employer where several exceptions explained below.4
Title I, Section 100, 105 Stat. 1107 an employee has made an individual This finding of grave danger is based on
(1991) (directing OSHA to complete the choice to pursue a less protective the science of how the virus spreads, the
BBP rulemaking by a date certain, and option. For the same reasons, OSHA has transmissibility of the disease in
providing that if OSHA did not do so, also determined that it is not workplaces, and the serious adverse
the proposed rule, which included a appropriate to require employers to pay health effects, including death, that can
vaccine provision, would become the for face coverings for employees who be suffered by those who are diagnosed
final standard). choose not to be vaccinated.2 with COVID–19. The protections of this
Additionally, OSHA’s authority to ETS—which will apply, with some
Finally, the Act and its legislative
require employers to bear the costs of limitations, to a broad range of
particular provisions of a standard is history ‘‘both demonstrate
unmistakably’’ OSHA’s authority to workplace settings where exposure to
solidly grounded in the OSH Act. The SARS–CoV–2 may occur—are designed
Act reflects Congress’s determination require employers to temporarily
remove workers from the workplace to to protect employees from infection
that the costs of compliance with the with SARS–CoV–2 and from the dire,
Act and OSHA standards are part of the prevent exposure to a health hazard.
United Steelworkers of Am., 647 F.2d at sometimes fatal, consequences of such
cost of doing business and OSHA may infection.
foreclose employers from shifting those 1230. And again, this is an authority
OSHA has repeatedly exercised in prior The fact that COVID–19 is not a
costs to employees. See Am. Textile uniquely work-related hazard does not
Mfrs. Inst., 452 U.S. at 514; Phelps standards, including in: COVID–19
Healthcare ETS (29 CFR 1910.502); Lead change the determination that it is a
Dodge Corp. v. OSHRC, 725 F.2d 1237, grave danger to which employees are
1239–40 (9th Cir. 1984); see also Sec’y (29 CFR 1910.1025); Cadmium (29 CFR
1910.1027); Benzene (29 CFR exposed, nor does it excuse employers
of Labor v. Beverly Healthcare-Hillview, from their duty to protect employees
541 F.3d 193 (3d Cir. 2008). Consistent 1910.1028); Formaldehyde (29 CFR
1910.1048); Methylenedianiline (29 CFR from the occupational transmission of
with this authority, OSHA has largely SARS–CoV–2. The OSH Act is intended
required employers to bear the costs of 1910.1050); Methylene Chloride (29
CFR 1910.1052); and Beryllium (29 CFR to ‘‘assure so far as possible every
the provisions of this ETS, including the working man and woman in the Nation
typical costs associated with 1910.1024). It is equally appropriate to
impose that obligation here. safe and healthful working conditions’’
vaccination. The allocation of (29 U.S.C. 651(b)), and there is nothing
vaccination costs to employers in this For all of these reasons, as well as in the Act to suggest that its protections
ETS is similar to OSHA’s treatment of those explained more fully in other do not extend to hazards which might
vaccine-related costs in the COVID–19 areas of this preamble, OSHA has the occur outside of the workplace as well
Healthcare ETS and the BBP standards. authority—and obligation—to as within. Indeed, COVID–19 is not the
See 29 CFR 1910.502(m), (p); 29 CFR promulgate this ETS. first hazard that OSHA has regulated
1910.1030(f)(1)(ii)(A).
References that occurs both inside and outside the
The OSH Act provides OSHA with
workplace. For example, the hazard of
discretion, however, to decide whether Centers for Disease Control and Prevention
to impose certain costs—such as those noise is not unique to the workplace,
(CDC). (2021, October 18). COVID Data
related to medical examinations or other but the Fourth Circuit has upheld
Tracker. https://covid.cdc.gov/covid-
tests—on employers ‘‘[w]here [it data-tracker/. (CDC, October 18, 2021) OSHA’s Occupational Noise Exposure
determines that such costs are] standard (29 CFR 1910.95) (Forging
III. Rationale for the ETS Industry Ass’n v. Sec’ of Labor, 773 F.2d
appropriate.’’ 29 U.S.C. 655(b)(7). OSHA
has determined that for purposes of this 1437, 1444 (4th Cir. 1985)). Diseases
A. Grave Danger
ETS, it would not be ‘‘appropriate’’ to caused by bloodborne pathogens,
impose on employers any costs I. Introduction including HIV/AIDS and hepatitis B, are
associated with COVID–19 testing for also not unique to the workplace, but
Section 6(c)(1) of the OSH Act the Seventh Circuit upheld the majority
employees who choose not to be requires the Secretary to issue an ETS in
vaccinated. For most of the agency’s of OSHA’s Bloodborne Pathogens
situations where employees are exposed standard (29 CFR 1910.1030) (Am.
existing standards containing medical to a ‘‘grave danger’’ and immediate
testing and removal provisions, OSHA Dental Ass’n v. Martin, 984 F.2d 823
action is necessary to protect those (7th Cir. 1993)). OSHA’s Sanitation
has found it necessary to impose the employees from such danger (29 U.S.C.
costs of such provisions on employers 655(c)(1)). Consistent with its legal 3 OSHA is defining the grave danger as workplace
in order to remove barriers to employee duties, OSHA is issuing this ETS to exposure to SARS–CoV–2, the virus that causes the
participation in medical examinations address the grave danger posed by development of COVID–19. COVID–19 is the
that are critical to effectuating the occupational exposure to SARS–CoV–2, disease that can occur in people exposed to SARS-
standards’ safety and health protections. CoV–2, and that leads to the health effects
described in this section. This distinction applies
See United Steelworkers of Am., 647 2 OSHA notes that while the ETS does not impose despite OSHA’s use of the terms SARS–CoV–2 and
F.2d at 1229–31, 1237–38. However, as these testing or face covering costs on employers, COVID–19 interchangeably in some parts of this
explained in greater detail elsewhere in in some circumstances employers may be required preamble.
this preamble (see Need for the ETS, to pay for the costs related to testing and/or face 4 OSHA refers to the grave danger from
Section III.B. of this preamble), the coverings by other laws, regulations, or collectively occupational exposure to SARS–CoV–2 throughout
negotiated agreements. OSHA has no authority this document. Those references are intended to
ETS’s safety and health protections are under the OSH Act to determine whether such encompass exposure to SARS–CoV–2 and all
best effectuated by employee obligations under other laws, regulations, or variants of SARS–CoV–2, including the Delta
vaccination, not testing. Accordingly, agreements might exist. variant.
App. 7
61408 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
standard, 29 CFR 1910.141, which that the OSH Act is not a ‘‘mathematical previous ETSs, there were no
requires measures such as cleaning, straitjacket,’’ nor does it require the documented cases of SARS–CoV–2
waste disposal, potable water, toilets, agency to support its findings ‘‘with infections in the United States until
and washing facilities, addresses anything approaching scientific January 2020. Since then, more than
hazards that exist everywhere—both certainty,’’ particularly when operating 725,000 people have died in the U.S.
within and outside of workplaces. on the ‘‘frontiers of scientific alone (CDC, October 18, 2021—
Moreover, employees have more knowledge’’ (Indus. Union Dep’t, AFL– Cumulative US Deaths). The pandemic
freedom to control their environment CIO v. Am. Petroleum Inst., 448 U.S. continues to affect workers and
outside of work, and to make decisions 607, 655–56 (1980)). Courts reviewing workplaces, with workplace exposures
about their behavior and their contact OSHA’s determination of grave danger leading to further exposures among
with others to better minimize their risk do so with ‘‘great deference’’ (Pub. workers’ families and communities.
of exposure. However, during the Citizen Health Research Grp. v. Clearly, SARS–CoV–2 is both a
workday, while under the control of Auchter, 702 F.2d 1150, 1156 (D.C. Cir. physically harmful agent and a new
their employer, workers may have little 1983)). In one case, the Fifth Circuit, in hazard that presents a grave danger to
ability to limit contact with coworkers, reviewing an OSHA ETS for asbestos, workers in the U.S.
clients, members of the public, patients, declined to question the agency’s Published on June 21, 2021, OSHA’s
and others, any one of whom could finding that 80 worker lives at risk Healthcare ETS (86 FR 32376) was
represent a source of exposure to SARS– nationwide over six months constituted written in response to the grave danger
CoV–2. OSHA has a mandate to protect a grave danger (Asbestos Info. Ass’n/N. posed to healthcare workers in the
employees from hazards they are Am., 727 F.2d at 424). OSHA estimates United States who faced a heightened
exposed to at work, even if they may be that this ETS would save over 6,500 risk of infection from COVID–19. In the
exposed to similar hazards outside of worker lives and prevent over 250,000 healthcare ETS, OSHA described its
work. hospitalizations over the course of the finding of grave danger for healthcare
As described above in Pertinent Legal next six months (OSHA, October 2021c). and healthcare support service workers
Authority (Section II. of this preamble), Here, the mortality and morbidity risk to (see 86 FR 32381–32412). OSHA now
‘‘grave danger’’ indicates a risk that is employees from COVID–19 is so dire finds that all unvaccinated workers,
more than ‘‘significant’’ (Int’l Union, that the grave danger from exposures to with some exceptions, face a grave
United Auto., Aerospace, & Agr. SARS–CoV–2 is clear. danger from the SARS–CoV–2 virus.6
Implement Workers of Am., UAW v. SARS–CoV–2 is both a physically II. Nature of the Disease
Donovan, 590 F. Supp. 747, 755–56 harmful agent and a new hazard (see 29 The health effects of symptomatic
(D.D.C. 1984); Indus. Union Dep’t, AFL– U.S.C. 655(c)(1)(A)). The majority of COVID–19 illness can range from mild
CIO v. Am. Petroleum Inst., 448 U.S. OSHA’s previous ETSs addressed toxic disease consisting of fever or chills,
607, 640 n.45, 655 (1980) (stating that a substances that had been familiar to the cough, and shortness of breath to severe
rate of 1 worker in 1,000 workers agency for many years prior to issuance disease. Severe cases can involve
suffering a given health effect of the ETS. OSHA’s Healthcare ETS, respiratory failure, blood clots, long-
constitutes a ‘‘significant’’ risk)). ‘‘Grave issued in response to COVID–19 earlier term cardiovascular and neurological
danger,’’ according to one court, refers this year, is one notable exception. In effects, and organ damage, which can
to ‘‘the danger of incurable, permanent, most cases, OSHA’s ETSs were issued in lead to hospitalization, ICU admission,
or fatal consequences to workers, as response to new information about and death (see 86 FR 32383–32388;
opposed to easily curable and fleeting substances that had been used in NINDS, September 2, 2021). Even in the
effects on their health’’ (Fla. Peach workplaces for decades (e.g., Vinyl short time since the Healthcare ETS’s
Growers Ass’n, Inc. v. U.S. Dep’t of Chloride (39 FR 12342 (April 5, 1974)); publication in June 2021, the risk posed
Labor, 489 F.2d 120, 132 (5th Cir. Benzene (42 FR 22516 (May 3, 1977)); by COVID–19 has changed
1974)). Fleeting effects were described 1,2-Dibromo-3-chloropropane (42 FR meaningfully. Since OSHA considered
as nausea, excessive salivation, 45536 (Sept. 9, 1977))). In some cases, the impact of COVID–19 when
perspiration, or blurred vision and were the hazards of the toxic substance were promulgating the Healthcare ETS, over
considered so minor that they often already so well established that OSHA 135,000 additional Americans have died
went unreported; these effects are in promulgated an ETS simply to update from COVID–19, and over 933,000 have
stark contrast with the adverse health an existing standard (e.g., Vinyl cyanide been hospitalized, (CDC, October 18,
effects of COVID–19 infections, which (43 FR 2586 (Jan. 17, 1978))). The 2021—Cumulative US Deaths; CDC,
are formally referenced as ranging from COVID–19 Healthcare ETS, which was May 28, 2021; CDC, October 18, 2021—
‘‘mild’’ to ‘‘critical,’’ 5 but which can issued in June 2021, was the sole Weekly Review). In August 2021,
involve significant illness, hospital instance in which OSHA issued an ETS COVID–19 was the third leading cause
stays, ICU care, death, and long-term to address a grave danger from a of death in the United States, trailing
health complications for survivors. substance that had only recently come only heart disease and cancer (Ortaliza
Beyond this, however, ‘‘the into existence. Although that action by et al., August 27, 2021). By September
determination of what constitutes a risk the agency was challenged, the case has 20, 2021, COVID–19 had killed as many
worthy of Agency action is a policy not gone to briefing (see United Food & Americans as the 1918–1919 flu
consideration that belongs, in the first Commercial Workers Int’l Union, AFL– pandemic (Johnson, September 20,
instance, to the Agency’’ (Asbestos Info. CIO, CLC and AFL–CIO v. OSHA, Dep’t 2021).
Ass’n/N. Am. v. OSHA, 727 F.2d 415, of Labor, D.C. Circuit No. 21–1143). While the Healthcare ETS addresses
425 (5th Cir. 1984)). Thus, no court has had occasion to the risk of illness and death from
In the context of ordinary 6(b) examine OSHA’s authority under
rulemaking, the Supreme Court has said section (6)(c) of the OSH Act (29 U.S.C. 6 When OSHA refers to ‘‘unvaccinated’’
655(c)) to address a grave danger from individuals in its grave danger finding, it means all
5 See the definitions for the different levels of individuals who are not fully vaccinated against
severity of COVID–19 illness in the National
a ‘‘new hazard.’’ Yet by any measure, COVID–19, i.e., those who are completely
Institutes of Health’s COVID–19 treatment SARS–CoV–2 is a new hazard. Unlike unvaccinated and those who are partially
guidelines (NIH, October 12, 2021). any of the hazards addressed in vaccinated.
App. 8
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61409
COVID–19 as the SARS–CoV–2 virus 4, 2021). CDC defines a VOC as ‘‘[a] be similarly, or even more, disruptive
continues to change over time, it does variant for which there is evidence of an (Liu and Rocklov, August, 4, 2021). In
not specifically address the increases in increase in transmissibility, more severe this context, it is critical that OSHA
infectiousness and transmission, and disease (e.g., increased hospitalizations address the grave danger from COVID–
the potentially more severe health or deaths), significant reduction in 19 that unvaccinated workers are
effects, related to the Delta variant. The neutralization by antibodies generated currently facing by requiring
rapid rise to predominance of the Delta during previous infection or vaccination and the other measures
variant in the U.S. occurred shortly after vaccination, reduced effectiveness of included in this rule, in order to
the ETS was published. At this time, the treatments or vaccines, or diagnostic significantly slow the transmission of
widespread prevalence of the Delta detection failures’’ (CDC, October 4,
COVID–19 in workers and workplaces
variant and its increased 2021).
While the proportions of SARS–CoV– and mitigate the rise of future variants.
transmissibility have resulted in
increased risk of exposure and disease 2 variants in the United States have b. Transmission
relative to the previously-dominant shifted over time (CDC, May 24, 2021c;
strains of the SARS–CoV–2 virus. CDC, October 18, 2021—Variant SARS–CoV–2 is a highly
Adding to the information covered in Proportions, July through October 2021), transmissible virus, regardless of
the Healthcare ETS, the following the primary variant that drove COVID– variant. Since the first case was detected
sections provide a brief review of 19 transmission in the late Winter and in the U.S., there have been close to 45
SARS–CoV–2 and describe the Spring of 2021 was the Alpha variant. million reported cases of COVID–19,
characteristics of the Delta variant that The CDC noted that Alpha is associated affecting every state and territory, with
are different from previous versions of with an increase in transmission, as thousands more infected each day (CDC,
SARS–CoV–2 and have changed the well as potentially increased incidences October 18, 2021—Cumulative US
risks posed by COVID–19. The agency of hospitalization and death, compared Cases), and some indication that these
specifically references the material to the predominant variants before its numbers continue to underestimate the
presented in the Healthcare ETS, which emergence (CDC, October 4, 2021; full burden of disease (CDC, July 27,
is still relevant to this analysis, to Pascall et al., August 24, 2021; Julin et
2021). According to the CDC, the
support OSHA’s finding of grave danger. al., September 22, 2021). As Alpha
primary way the SARS–CoV–2 virus
Taken together, the information transmission subsided in the United
States during the late Spring and early spreads from an infected person to
available to OSHA demonstrates that
SARS–CoV–2 poses a grave danger to Summer of 2021, Delta emerged and others is through the respiratory
unvaccinated workers across all quickly became the predominant variant droplets that are produced when an
industry sectors. in the U.S. by July 3, 2021 (CDC, infected person coughs, sneezes, sings,
October 18, 2021—Variant Proportions, talks, or breathes (CDC, May 7, 2021).
a. Variants of SARS–CoV–2 July through October 2021). Delta now Infection could then occur when
Viral mutations have been a serious accounts for more than 99% of another person breathes in the virus.
concern of scientists, public health circulating virus nationwide (CDC, Most commonly this occurs when
experts, and policymakers from the October 18, 2021—Variant Proportions, people are in close contact with one
beginning of the COVID–19 pandemic. July through October 2021). another in indoor spaces (within
Viral mutations can affect how a virus FDA authorized and approved approximately six feet for at least fifteen
interacts with a cell—altering the virus’s COVID–19 vaccines currently work well minutes) (CDC, August 13, 2021).
transmissibility, infection severity, and against all of these variants; however, Additionally, airborne transmission may
sensitivity to vaccines. The U.S. there are differences in various variants’ occur in indoor spaces without adequate
government’s SARS–CoV–2 Interagency ability to spread and the likelihood of ventilation where small respiratory
Group has a variant classification infection to cause severe illness. Data on particles are able to remain suspended
scheme that defines four classes of the Beta and Gamma variants do not
in the air and accumulate (CDC, May 7,
SARS–CoV–2 variants: Variants Being indicate that infections from these
2021; Fennelly, July 24, 2020). While
Monitored (VBM), Variants of Interest variants caused more severe illness or
(VOI), Variants of Concern (VOC), and death than other VOCs. Data on the scientists’ understanding of the Delta
Variants of High Consequence (VOHC). Alpha variant does indicate its ability to variant’s virology is evolving and
These variant designations are based on cause more severe illness and death in remains at the frontier of science,
their ‘‘proportions at the national and infected individuals. And some data on current data shows that the routes of
regional levels and the potential or the Delta variant suggests that the Delta transmission remain the same for all
known impact of the constellation of variant may cause more severe illness currently-identified SARS–CoV–2
mutations on the effectiveness of than previous variants, including Alpha, variants. In addition, all variants can be
medical countermeasures, severity of in unvaccinated individuals (CDC, transmitted by people who are pre-
disease, and ability to spread from October 4, 2021). symptomatic (i.e., people who are
person to person’’ (CDC, October 4, The emergence of the Delta variant, infected but do not yet feel sick) or
2021), with VOIs considered less serious along with other VOCs, has resulted in asymptomatic (i.e., people who are
than VOCs and VOCs considered less a more deadly pandemic (Fisman and infected but never feel any symptoms of
serious than VOHCs. As of early October Tuite, July 12, 2021). While the Delta COVID–19), as well as those who are
2021, the CDC was monitoring 10 variant is the most transmissible SARS– symptomatic. Pre-symptomatic and
VBMs—Alpha (B.1.1.7, Q.1–Q.8), Beta CoV–2 variant to date, the possibility asymptomatic transmission continue to
(B.1.351, B.1.351.2, B.1.351.3), Gamma remains for the rise of future VOCs, and pose serious challenges to containing
(P.1, P.1.1, P.1.2), Epsilon (B.1.427 and even more dangerous VOHCs, as the the spread of COVID–19. For more
B.1.429), Eta (B.1.525), Iota (B.1.526), virus continues to spread and mutate. extensive information on transmission
Kappa (B.1.617.1), B.1.617.3, Mu Inadequate vaccination rates and the
routes, as well as pre-symptomatic and
(B.1.621, B.1.621.1), and Zeta (P.2)—and abundance of transmission create an
asymptomatic transmission, see the
one VOC—Delta (B.1.617.2 and AY.1 environment that can foster the
sublineages)—in the U.S. (CDC, October development of new variants that could preamble to the Healthcare ETS (86 FR
App. 9
61410 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
32392–32396), which is hereby September 15, 2021). Updated mortality The comorbidities that further
included in the record of this ETS.7 data 8 currently indicate that people of exacerbate COVID–19 infections are
The Delta variant is transmitted from working age (18–64 years old) now have common among adults of working age in
infectious individuals via the same a 1 in 202 chance of dying when they the U.S. For instance, 46.1% of
routes as previous variants, but is much contract the disease, with the risk much individuals with cancer are in the 20–
more transmissible. Specifically, Delta higher (1 in 72) for those aged 50–64 64 year old age range (NCI, April 29,
differs from previous dominant variants (CDC, October 18, 2021—Demographic 2015), and over 40% of working age
of SARS–CoV–2 in terms of the Trends, Cases by Age Group; CDC, adults are obese (Hales et al., February
amplification of viral particles expelled October 18, 2021—Demographic Trends, 2020). Disease severity is also likely
from infected individuals. Testing of Deaths by Age Group). For a more in- exacerbated by long-standing healthcare
Delta-infected individuals indicates that depth description of the health effects inequities experienced by members of
their viral loads are—on average— resulting from SARS–CoV–2 infection, many racial and economic
approximately 1,000x greater than those see the preamble to the Healthcare ETS demographics (CDC, April 19, 2021).
of the SARS–CoV–2 variants from the (86 FR 32383–32392), which is hereby Recent data suggests that Delta variant
first COVID–19 wave in early 2020. This included in the record of this ETS.9 infections may result in even more
finding suggests much faster replication Apart from fatal cases, COVID–19 can severe illness and a higher frequency of
of viral particles during early infection cause serious illness, including long- death than previous COVID–19 variants
with the Delta variant, resulting in lasting effects on health. Many patients due to Delta’s increased transmissibility,
greater infectiousness (contagiousness) who become ill with COVID–19 require virulence, and immune escape (Fisman
when compared to earlier versions of hospitalization. Indeed, updated CDC and Tuite, July 12, 2021). Symptomatic
SARS–CoV–2 (Li et al., July 12, 2021). hospitalization and mortality data Delta variant infections do occur in fully
The transmissibility of viruses is indicate that working age Americans vaccinated people (Mlcochova et al.,
measured in part by the average number (18–64 years old) now have a 1 in 14 June 22, 2021; Musser et al., July 22,
of subsequently-infected people (or chance of hospitalization when infected 2021); however, as reported by the CDC
secondary cases) that are expected to with COVID–19 (CDC, October 18, (CDC, August 26, 2021), the vast
occur from each existing case (often 2021—Demographic Trends, Cases by majority of the continuing instances of
referred to as R0). Several comparisons Age; Total Hospitalizations, by Age). severe and fatal COVID–19 infections
of the transmissibility of the initial Those who are hospitalized frequently are occurring in unvaccinated persons
SARS–CoV–2 variants to the Delta need supplemental oxygen and (discussed further in Grave Danger,
variant have shown that Delta is treatment for the disease’s most Section III.A.IV. Vaccines Effectively
approximately twice as transmissible common complications, which include Reduce Severe Outcomes from and
(contagious) as previous versions of pneumonia, respiratory failure, acute Transmission of SARS–CoV–2). An
SARS–CoV–2 (CDC, August 26, 2021; respiratory distress syndrome (ARDS), assessment of Delta-related hospital
Riou and Althaus, January 30, 2020; Li acute kidney injury, sepsis, myocardial admissions in Scotland found that
et al., July 12, 2021; Liu and Rocklov, injury, arrhythmias, and blood clots. hospitalizations were approximately
August, 4, 2021), likely the result of One study, which included 35,502 doubled in patients with the Delta
higher initial viral loads during the pre- inpatients nationwide, determined that variant when compared to the Alpha
symptomatic phase (Li et al., July 12, the median length of hospital stay was variant (Sheikh et al., June 4, 2021). A
2021). In addition, as described further 6 days, unless the cases required ICU similar study conducted using a
below, data on Delta shows that both treatment. For those cases, ICU stays retrospective cohort in Ontario, Canada
unvaccinated and vaccinated were on median 5 days in addition to compared the virulence of novel SARS–
individuals are more likely to transmit the time spent hospitalized outside of CoV–2 variants and found that the
Delta than previous variants (Liu and the ICU (Rosenthal et al., December 10, incidences of hospitalization, ICU
Rocklov, August, 4, 2021; Eyre et al., 2020). Another study that assessed admission, and death were more
September 29, 2021), making it hospital length of stay for COVID–19 pronounced with the Delta variant than
especially dangerous to those who patients in England estimated that a any other SARS–CoV–2 variant (Fisman
remain unvaccinated. non-ICU hospital stay averaged between and Tuite, July 12, 2021). A large
8 and 9 days, but those estimates ranged national cohort study that included all
c. Health Effects
from approximately 12 to 18 days when Alpha and Delta SARS–CoV–2 patients
COVID–19 infections can lead to patients were admitted to the ICU in England between March 29 and May
death. As reported in the Healthcare (Vekaria et al., July 22, 2021). Moreover, 23, 2021 found a ‘‘higher hospital
ETS, by May 24, 2021, there had been given that SARS–CoV–2 is still a novel admission or emergency care attendance
587,432 deaths and 32,947,548 million virus, the severity of long-term health risk for patients with COVID–19
infections in the U.S. alone (CDC, May effects—such as ‘‘post-COVID infected with the Delta variant
24, 2021a; CDC, May 24, 2021b). At that conditions’’—are not yet fully compared with the Alpha variant,’’
point in the pandemic, 1.8 out of every understood. suggesting that Delta outbreaks—
1,000 people in the U.S. had died from Many members of the workforce are at especially amongst unvaccinated
COVID–19 (CDC, May 24, 2021a). Since increased risk of death and severe populations—may lead to more severe
then, reported cases have increased to disease from COVID–19 because of their health consequences and an equivalent
44,857,861 and the number of deaths age or pre-existing health conditions. or greater burden on healthcare services
has increased to 723,205 (CDC, October
than the Alpha variant (Twohig et al.,
18, 2021– Cumulative US Cases; 8 Risk of death is based on averages from reported
August 27, 2021). However, one more
Cumulative US Deaths). By September CDC data. Risks of hospitalization and death are
much higher in unvaccinated individuals, as recent study examining data from
2021, an astounding 1 in 500 Americans discussed further in Grave Danger, Section III.A.IV. several U.S. states demonstrated a
had died from COVID–19 (Keating, Vaccines Effectively Reduce Severe Health significant increase in hospitalization
Outcomes from and Transmission of SARS–CoV–2.
7 This adoption includes the citations in the 9 This adoption includes the citations in the from the pre-Delta to the Delta period,
referenced section of the Healthcare ETS, which are referenced section of the Healthcare ETS, which are which may be related to increased
also included in the docket for this ETS. also included in the docket for this ETS. transmissibility of Delta rather than
App. 10
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61411
more severe health outcomes (Taylor et widespread effects of SARS–CoV–2 in articles described below establish the
al., October 22, 2021). industry sectors across the national widespread prevalence of COVID–19
economy. While the focus is on more among employees, beginning with a
III. Impact on the Workplace
recent data reflecting the impact of the description of the recent impact from
SARS–CoV–2 is readily transmissible Delta variant, evidence of workplace the Delta variant. OSHA’s findings are
in workplaces because they are areas transmission that occurred prior to the based primarily on the evidence from
where multiple people come into emergence of the Delta variant is also peer-reviewed scientific journal articles
contact with one another, often for presented. and government reports. However, peer
extended periods of time. When The workplace-based clusters review for scientific journal articles and
employees report to their workplace, described below provide evidence that the assembly of information for
they may regularly come into contact workplaces in a wide range of industries government reports and other official
with co-workers, the public, delivery have been affected by COVID–19, that sources of information take time, and
people, patients, and any other people many employees face exposure to therefore those sources do not always
who enter the workplace. Workplace infected people in their workspaces, and reflect the most up-to-date information
factors that exacerbate the risk of that SARS–CoV–2 transmission is (Chan et al., December 14, 2010). In
transmission of SARS–CoV–2 include occurring in the workplace, including addition, while state and local health
working in indoor settings, working in during the recent period where the Delta departments can report workplace
poorly-ventilated areas, and spending variant has predominated. Although the outbreaks to CDC, the agency does not
hours in close proximity with others. presence of a cluster on its own does not provide summary statistics by
Full-time employees typically spend 8 necessarily establish that the cluster is workplace so that those outbreaks can
hours or more at work each shift, more work-related (i.e., a result of be tracked on a national level. In the
time than they spend anywhere else but transmission at the worksite), many context of the COVID–19 pandemic,
where they live. Employees work in state investigation reports and given the recent impacts due to the
proximity to others in workplaces that published studies provide evidence that Delta variant and the emergence of new
were not originally designed to keep transmission is work related by information on a daily basis, it is critical
people six feet away from other people documenting that infections at a for OSHA to rely on the most up-to-date
and that may make it difficult for workplace occurred within 14-days (the information available. Therefore, OSHA
employees to perform work tasks while incubation period for the virus) of each has occasionally supplemented peer-
maintaining a six-foot distance from other and ruling out the possibility that reviewed data and government reports
others. Even in the cases where workers transmission occurred outside the with additional information on
can do most of their work from, for workplace. In addition, the information occupational outbreaks contained in
example, a private office within a below demonstrates that exposures to other sources of media (e.g.,
workplace, they share common areas SARS–CoV–2 happen regularly in a newspapers, digital media, and
like hallways, restrooms, lunch rooms wide variety of different types of information submitted to or obtained by
and meeting rooms. Furthermore, many workplaces. private organizations).10 The reported
work areas are poorly ventilated (Allen The basis for OSHA’s grave danger
information from other sources can
and Ibrahim, May 25, 2021; Lewis, finding is that employees can be
provide further evidence of the impact
March 30, 2021). An additional factor exposed to the virus in almost any work
of an emerging and changing disease,
that exacerbates the risk of transmission setting; that exposure to SARS–CoV–2
of SARS–CoV–2 is interacting with or especially for industries that are not
can lead to infection (CDC, September
caring for people with suspected or well represented in the peer-reviewed
21, 2021); and that infection in turn can
confirmed COVID–19; this was a cause death or serious impairment of scientific literature. Together, these
primary driver of OSHA’s determination health, especially in those who are sources of information represent the
of grave danger for healthcare workers unvaccinated (see Section III.A.IV. best available evidence of the impact on
in the Healthcare ETS (see 86 FR 32381– Vaccines Effectively Reduce Severe employees of the pandemic thus far.
32383). In recent weeks, the majority of Health Outcomes from and The information described herein
states in the U.S. have experienced what Transmission of SARS–CoV–2). The illustrates a significant number of
CDC defines as ‘‘high or substantial information described in this section infections among employees in a variety
community transmission,’’ indicating supports OSHA’s finding that of industries, with virtually every state
that there is a clear risk of the virus employees who work in spaces shared continuing to experience what CDC
being introduced into and circulating in by others are at risk of exposure to defines as high or substantial
workplaces (CDC, October 18, 2021— SARS–CoV–2. The degree of risk from community transmission related to the
Community Transmission Rates). droplet-based transmission may vary recent surge of the Delta variant. The
Although COVID–19 is not based on the duration of close proximity industries and types of workplaces
exclusively an occupational disease, it to a person infected with SARS–CoV–2, described are not the only ones in
is evident from research accrued since including the Delta variant, but the which a grave danger exists. The science
the beginning of the pandemic that simple and brief act of sneezing, of transmission does not vary by
SARS–CoV–2 transmission can and coughing, talking, or even breathing can industry or by type of workplace. OSHA
does occur in workplaces, affecting significantly increase the risk of therefore expects transmission to occur
employees and their lives, health, and transmission if controls are not in place. in diverse workplaces all across the
livelihoods. This continues to be true SARS–CoV–2, including the Delta country (see Dry Color Mfrs. Ass’n, Inc.
for the Delta variant, with its increased variant, might also be spread through v. Dep’t of Labor, 486 F.2d 98, 102 n.3
transmissibility and potentially more airborne particles under certain (3d Cir. 1973) (holding that when OSHA
severe health effects. This section conditions, particularly in enclosed determines a substance poses a grave
describes some of the clusters, settings with inadequate ventilation,
10 OSHA did not make findings based solely on
outbreaks, and other occurrences of which are common characteristics of
non-peer-reviewed sources such as news articles,
workplace COVID–19 cases that some workplaces. but the agency found that those sources can
government agencies, researchers, and The peer-reviewed scientific journal sometimes provide useful information when
journalists have described, and the articles, government reports, and news considered with more robust sources.
App. 11
61412 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
danger to workers, OSHA can assume an recent infections might be investigating more than 124 active
exposure to a grave danger exists underestimated. Some of the reports workplace outbreaks (OHA, September
wherever that substance is present in a include cumulative data representing 1, 2021). Those outbreaks occurred in a
workplace)). In addition, the severity of various phases of the pandemic, wide variety of industries including
COVID–19 does not depend on where beginning prior to the availability of correctional facilities, emergency
an employee is infected; an employee vaccines and continuing through the services, waste management, schools
exposed to SARS–CoV–2 might die recent surge of the Delta variant. In and child care, retail and grocery stores,
whether exposed while working at a addition, some studies report restaurants, warehousing, agriculture,
meat packing facility, a retail investigations of recent outbreaks, food processing/packaging,
establishment, or an office (see Grave which provide insight on the impact of construction, healthcare, mail and
Danger, Section III.A.V.b. Employees the Delta variant as well as impacts delivery services, office locations,
Who Work Exclusively Outside, below, associated with the current vaccination utilities, transportation, and others.
for a discussion of the risk of exposure status of workers. Tennessee Department of Health was
in outdoor workplaces). The Washington State Department of investigating 557 active COVID–19
Health (WSDH) reports outbreaks clusters as of September 8, 2021 (TDH,
a. General Impact on Workers occurring in non-healthcare workplaces September 8, 2021). Clusters are defined
Data on SARS–CoV–2 infections, (WSDH, September 8, 2021). In non- as two or more laboratory confirmed
illnesses, and deaths among employees healthcare workplaces, outbreaks are COVID–19 cases linked to the same
in general industry, agriculture, defined as two or more laboratory location or event that is not a household
construction, and maritime support confirmed cases of COVID–19, with at exposure. The clusters occurred in 13
OSHA’s finding that COVID–19 poses a least two cases reporting symptom onset types of settings, 10 of which were
grave danger to employees in these within 14 days of each other, and workplace settings. Outbreaks at
sectors across the U.S. economy. This plausible epidemiological evidence of workplaces represented more than half
section summarizes studies and reports transmission in a shared location other of the total active outbreaks in the state
of COVID–19 illness and fatalities in a than a household. As of September 4, at that time. Settings comprising more
wide range of workplaces across those 2021, WSDH reported 5,247 outbreaks than 5% of total clusters included
industry sectors. Not all workplace in approximately 40 different types of assisted care living facilities, nursing
settings are discussed; nor is the data non-healthcare work settings. During homes, and correctional facilities. Other
available to do so. However, the the week of August 29 through types of workplaces where outbreaks
characteristics of the various affected September 4, 2021, WSDH identified occurred included bars, construction,
workplaces—such as indoor work 137 separate workplace outbreaks. The farms, homeless shelters, and industrial
settings; contact with coworkers, clients, types of non-medical workplace settings settings.
or members of the public; and sharing that represented more than 5% of the The North Carolina Department of
space with others for prolonged periods total outbreaks during that week Health and Human Services reports
of time—indicate that exposures to included food service/restaurants, cumulative numbers of clusters, cases,
SARS–CoV–2 are occurring in a wide childcare, schools, retail, grocery, and and deaths for workers in poultry
variety of work settings across all shelter/homeless services. Other types processing facilities (beginning in April
industries. Therefore, most employees of non-healthcare settings where of 2020) and other types of workplaces
who work in the presence of other outbreaks occurred recently included (beginning in May of 2020) (NCDHHS,
people (e.g., co-workers, customers, non-food and food manufacturing, August 30, 2021). Clusters are defined
visitors) need to be protected. construction, professional services/ as a minimum of 5 cases with illness
While there is no comprehensive office based, agriculture/produce onset or initial positive results within a
source of nationwide workplace packing, transportation/shipping 14-day period and plausible
infection data, reports from states and delivery, government agencies/facilities, epidemiological linkage between the
communities on outbreaks related to leisure hospitality/recreation, cases. Plausible epidemiological linkage
workplaces provide key, up-to-date data corrections, utilities, warehousing, means that multiple cases were in the
that illustrate the likelihood of facility/domestic cleaning services, same general setting during the same
employee exposure to SARS–CoV–2 at youth sports/activities, camps, and time period (e.g., same shift, same
workplaces throughout the U.S. OSHA public safety. Over the course of the physical area) and that a more likely
identified a number of recent reports pandemic, outbreaks have also been source of exposure is not identified (e.g.,
from various regions of the country that observed at bars/nightclubs, hotels, and household contact or close contact to a
together demonstrate the impact that fishing/commercial seafood vessels. confirmed case in another setting).
SARS–CoV–2 can have on a variety of The Oregon Health Authority (OHA) During that time period of April/May
workplaces, including in service publishes a weekly report detailing 2020 through August 30, 2021,
industries (e.g., restaurants, grocery and outbreaks directly related to work workplaces 11 were associated with
other retail stores, fitness centers, settings. OHA epidemiologists consider nearly 80% of the 1,969 clusters and
hospitality, casinos, salons), corrections, cases to be part of a workplace outbreak 27,097 cases observed and nearly 40%
warehousing, childcare, schools, offices, when clusters form with respect to of the 167 deaths related to the clusters.
homeless shelters, transportation, mail/ space and time, within a plausible Cumulative numbers of cluster-
shipping/delivery services, cleaning incubation period for the virus, and associated deaths were highest in meat
services, emergency services/response, their investigation does not uncover an and poultry processing (25 of 5,351
waste management, construction, alternative source for the outbreak. For cases), followed by healthcare (10 of
agriculture, food packaging/processing, privacy reasons, OHA only reports 1,036 cases), government services and
and healthcare. Deaths are reported in outbreaks with 5 or more cases in manufacturing (5 of 1,048 cases and 5 of
many studies performed prior to the workplaces with 30 or more people.
emergence of the Delta variant but, OHA reported a total of 26,013 cases 11 NCDHHS identifies a ‘‘workplace’’ category in
because the Delta outbreak is so recent and 135 deaths related to workplace their report (e.g., agriculture, construction), but
OSHA includes other settings where employees
and deaths can occur weeks after outbreaks as of September 1, 2021. As would be present (e.g., retail, restaurants, childcare,
infection, the number of deaths from of September 1, 2021, OHA was healthcare).
App. 12
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61413
1,856 cases, respectively), and through May 3, 2021 (Dougherty et al., represented 10.2% of the outbreaks. The
restaurants and childcare (3 of 421 cases July 16, 2021). All 21 of the virus study authors concluded that outbreaks
and 3 of 1,943 cases, respectively). samples sequenced were determined to were larger and lasted longer at facilities
Recently, in July of 2021, the number of be the Delta variant. The majority of the with more onsite staff.
cases associated with workplace clusters infected individuals (85%) were Outbreaks in Wisconsin from March 4
began increasing in several different unvaccinated. Infections were reported through November 16, 2020 were also
types of work settings, including meat in 16 adults aged 20 years or older; two examined (Pray et al., January 29, 2021).
processing, manufacturing, retail, adults were hospitalized and one Non-household outbreaks were defined
restaurants, childcare, schools, and required intensive care. as two or more confirmed COVID–19
higher education. The state of Hawaii defines clusters as cases that occurred within 14 days in
Colorado Department of Public Health three or more confirmed or probable persons who attended the same facility
& Environment/Colorado State cases linked to a site or event within 14 or event and did not share a household.
Emergency Operations Center (CDPHE/ days, with no outside exposure of cases During the period from March 4 through
CSEOC, September 8, 2021) reported to each other (Hawaii State, August 19, November 16, 2020, the largest
5,584 resolved workplace-related 2021). The state reported a COVID–19 percentages of cases were associated
outbreaks involving 40,156 employee cluster in July associated with a concert with outbreaks in long-term care
cases and 79 employee deaths since at a bar that affected 16 people, facilities (26.8% of cases), correctional
May of 2020. The agency’s current including employees, band members, facilities (14.9% of cases), and colleges
investigations, as of September 8, 2021 and concert attendees; infections also or universities (15% of cases). Also
included 291 active outbreaks (not spread to 7 household members. Band notable were the substantial number of
defined), with 2,865 staff cases members had performed while sick. cases associated with outbreaks in food
(assumed to be cases in employees). The Four of the initial 16 people and none production or manufacturing facilities
majority of active outbreaks were of the household members who tested (including meat processing and
reported in childcare, schools, positive for COVID–19 were fully warehousing; 14.5% of cases) and
healthcare, and corrections. Active vaccinated. The concert cluster was schools and childcare facilities (10.6%
outbreaks were also reported in linked to clusters at another workplace of cases).
construction, retail, homeless shelters, and another concert. The report lists
Bui et al. (August 17, 2020) analyzed
casinos, restaurants, hotels, offices, law additional clusters investigated in the
data from the Utah Department of
enforcement, manufacturing, delivery two weeks prior to the report; those
services, and warehouses. Other types of clusters were observed in workplace Health’s COVID–19 case surveillance
work settings that were affected in locations such as correctional facilities, system, which included data on
resolved outbreaks included bars and nightclubs, restaurants, workplace outbreaks. Outbreaks were
warehouses, bars, government locations, construction/industrial sites, travel/ defined as two or more laboratory
waste management, utilities, salons, lodging/tourism, schools, food confirmed cases occurring within a 14
emergency services, meat processing/ suppliers, and gyms. day period among coworkers in a
packaging, and postal services. From Additional evidence that employees common workplace (e.g., same facility).
June 21, 2021 (the date the healthcare are at risk of exposure to SARS–CoV–2 During the time period between March
ETS was published) through September in the workplace is available from 6 and June 5, 2020, 277 COVID–19
8, 2021, 1,469 staff cases associated with published, peer-reviewed studies that outbreaks were reported, of which 210
outbreaks were reported, for an average were conducted before the Delta variant (76%) occurred in workplaces. The 210
of approximately 19 cases per day. emerged. Those studies demonstrate workplace outbreaks occurred in 15 of
Similar reporting is available from that employees have been at risk of 20 industry sectors, and the industry
Louisiana’s Department of Health (LDH, infection, illness, and death throughout sectors of manufacturing (43 outbreaks,
August 24, 2021), with 1,347 outbreaks the COVID–19 pandemic. Because the 20%), construction (32 outbreaks, 15%),
and 9,130 cases reported as of August Delta variant is more transmissible and and wholesale trade (29 outbreaks, 14%)
24, 2021. LDH defines an outbreak as 2 likely causes more severe disease than together represented nearly half of
or more cases among unrelated previous variants, there is even greater workplace outbreaks. Other sectors that
individuals who visited a site within a potential for unvaccinated employees to represented more than 10% of total
14-day period. More than three quarters become seriously ill or die as a result of outbreaks were retail trade (28
of outbreaks through that date were exposure to the Delta variant. outbreaks, 13%) and accommodation
associated with workplaces. Workplace Contreras et al. (July, 2021) examined and food services (25 outbreaks, 12%).
settings in Louisiana that experienced workplace outbreaks (excluding Incidence rates of COVID–19 over the
more than 5% of outbreaks included healthcare settings, homelessness period of March 6 through June 5, 2020
day care facilities, bars, restaurants, services, and emergency medical were 339/100,000 workers in
retail settings, industrial settings, and services) in Los Angeles county from manufacturing, 122/100,000 workers in
office spaces. Other types of workplace March 19 through September 30, 2020. construction, 377/100,000 workers in
settings or industries where outbreaks Workplace outbreaks were defined as 5 wholesale trade, 68/100,000 workers for
occurred included casinos, gyms/fitness or more suspected or laboratory retail trade, and 78/100,000 workers for
centers, banks, automotive services, confirmed COVID–19 cases (prior to accommodation and food services. For
construction, and ships/boats. May 29) or 3 or more laboratory COVID–19 cases associated with
In addition to the state data above, confirmed cases (after May 29) workplace outbreaks in which
some published studies and government occurring within 14 days. Nearly 60% of hospitalization and severity status were
reports provide information on recent the 698 identified outbreaks occurred in known (1,382 and 1,155, respectively),
workplaces outbreaks. For example, 47 three sectors—manufacturing (184, the number in all sectors who were
people, including 3 of 11 staff members, 26.4%), retail trade (137, 19.6%), and admitted to the hospital was 85 (6%)
23 gymnasts, and 21 household transportation and warehousing (73, and the number with severe outcomes
contacts, contracted COVID–19 from an 10.5%). Also notable were the 71 (intensive care unit admission,
outbreak linked to an Oklahoma outbreaks in the accommodation and mechanical ventilation, or death) was 40
gymnastics facility during April 15 food services industry, which (3%).
App. 13
61414 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
The impact of SARS–CoV–2 A COVID–19 case was determined to be facilities face challenges in controlling
exposures on employee infection, school-related if (1) symptom onset or a the spread of infectious diseases
illness, and death has also been positive test was consistent with the because of crowded, shared
demonstrated in studies focusing on incubation period of the virus following environments and potential
specific types of industries, such as contact with an index case or a school- introductions by staff members and new
those where employees have frequent associated case, (2) close contact intakes.’’
contact with each other and the public occurred with the index case or school- Ward et al. (June 2021) analyzed
(e.g., grocery stores, bars, fitness associated case while that person was COVID–19 prevalence among prisoners
facilities, schools, and law enforcement/ infected, and (3) no known contact and staff in 45 states from March 31,
corrections). For example, a study by occurred with an infected community or 2020 through November 4, 2020. During
Lan et al. (September 26, 2020) household contact in the two weeks that time period, COVID–19 cases in
demonstrates the risk of infection in prior to a positive test for COVID–19. staff were 3 to 5 times higher compared
service industries. The cross-sectional The investigators identified nine to the U.S. population. Average daily
study examined the risks of SARS–CoV– clusters of three or more increases in cases were 42 per 100,000
2 exposure and infection for employees epidemiologically linked COVID–19 prison employees, 61 per 100,000
in a Boston, Massachusetts-area retail cases that involved 13 educators and 32 prisoners, and 13 per 100,000 U.S.
grocery store market. The study tested students in six of the eight elementary residents. On November 4, 2020,
104 grocery store employees, of whom schools. Approximately half of the COVID–19 prevalence for prison staff
20% (21 employees) were positive for school-associated cases involved two was 9,316 cases per 100,000 employees,
COVID–19; 76% of confirmed cases did clusters that began with probable which was 3.2 times greater than
not have symptoms. After adjusting for transmission between educators, prevalence in the U.S. population (2,900
gender, smoking, age, and the followed by educator to student cases per 100,000).
prevalence of COVID–19 in the transmission. Eighteen of 69 household Kirbiyik et al. (November 6, 2020)
employees’ residential communities, members tested received positive analyzed movement through a network-
employees who had direct customer results. informed approach to identify likely
exposure (e.g., cashiers, sales associates, A number of studies demonstrate the high points of transmission within the
cart attendants) were 5.1 times more impact of COVID–19 in law enforcement Cook County Jail in Chicago, IL. At that
likely to have a positive test for COVID– and related fields such as corrections. facility, over 900 COVID–19 cases were
19 than employees without direct face- For example, a study examining reported across 10 housing divisions in
to-face customer exposure (e.g., COVID–19 antibodies in employees 13 buildings from March 1–April 30,
stockers, backroom, receiving and from public service agencies in the New 2020. Staff members were required to
maintenance). The infection rate of 20% York City area from May through July of report symptoms of COVID–19
among all employees was significantly 2020, found that 22.5% of participants (probable cases) or receipt of a positive
higher than the rate in the surrounding had COVID–19 antibodies (Sami et al., test result (confirmed cases). A total of
community. March, 2021). The percentage of 2,041 staff members (77% of staff) were
In February of 2021, an event at an correctional officers found to have included in the network analysis
Illinois bar that accommodates COVID–19 antibodies (39.2%) was the because information was available about
approximately 100 people resulted in a highest observed among all the their shift and division assignments,
COVID–19 outbreak that affected 46 occupations. The percentages of police and 198 (9.7%) of those staff members
people, including 3 (10%) staff dispatchers, traffic officers, security had COVID–19 during the two-month
members, 26 (90%) patrons, and 17 guards, and dispatchers found to have study period. Connections between staff
secondary cases (Sami et al., April 9, COVID–19 antibodies (29.8 to 37.3%) members who had COVID–19 were
2021). People at the event included an were among the highest levels observed higher than expected, suggesting likely
asymptomatic person diagnosed with in all the occupations. The study transmission among staff members.
COVID–19 on the previous day and 4 authors noted that those jobs involve Fewer connections than expected were
symptomatic people who were later frequent or close contact with the public observed among detained persons with
diagnosed with COVID–19. The or are done in places where employees SARS–CoV–2 infections, suggesting the
outbreak resulted in a school closure work in close proximity to their effectiveness of medical isolation at
and the hospitalization of a resident at coworkers. reducing transmission.
a long-term care facility. Wallace et al. (May 15, 2020) The Officer Down Memorial Page,
In Minnesota, 47 COVID–19 outbreaks evaluated data on COVID–19 cases and which tracks police officer fatalities
were detected at fitness facilities from deaths among correctional facility determined to be occupationally related,
August through November of 2020 employees and inmates from January 21 reported that the majority of officer
(Suhs et al., July 23, 2021). One to April 21, 2020. Data were reported to deaths for 2021 (157 of 269) were
outbreak at a fitness facility during CDC by 37 (69%) of 54 state and related to COVID–19 (ODMP, September
October through November of 2020 territorial health department 14, 2021). For the 269 officers who died,
resulted in 23 COVID–19 cases jurisdictions. Of these 37 jurisdictions, causes of death were not reported for
including 5 (22%) employees and 18 32 (86%) reported at least one COVID– each month, but the highest numbers of
(78%) members. A genetic analysis of 19 case from a correctional facility. Of monthly deaths, 52 in January and 65 in
specimens from 3 employees and 10 the 420 facilities with a case, 221 (53%) August (compared to 16 to 34 deaths on
members identified 2 distinct genetic reported cases only among staff other reported months), were consistent
subclusters, indicating two distinct members. In total, 4,893 COVID–19 with the winter surge of COVID–19 and,
chains of transmission among members cases among incarcerated or detained more recently, the surge caused by the
and employees. persons and 2,778 cases among staff Delta variant.
School-related outbreaks were members were reported (total tested not The risk of COVID–19 has also been
examined from December 1, 2020 provided). Among staff member cases, examined in industries where
through January 22, 2021 in eight public 79 hospitalizations (3%) and 15 deaths employees have little contact with the
elementary schools of a Georgia school (1%) were reported. The study authors public, such as construction, and food
district (Gold et al., February 26, 2021). noted that ‘‘correctional and detention processing, and where most exposure to
App. 14
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61415
SARS–CoV–2 likely comes from other who died in each state ranged from 0.1 (18–65 years) increased 22% during the
workers. Pasco et al. (October 29, 2020) to 2.4% of those with COVID–19. The COVID–19 pandemic period of March
examined the association between authors found a high burden of disease through November 2020 compared to
construction work during the COVID–19 in persons employed at these facilities pre-pandemic periods. Relative to pre-
pandemic and community transmission who were racial or ethnic minorities. pandemic periods, the groups of
and construction worker hospitalization Higher incidence in these populations employees experiencing the highest,
rates in Austin, Texas from March 13 to might be due to the likelihood of these statistically significant increases in
August 20, 2020. A ‘‘Stay Home-Work employees working in areas in the plant relative excess mortality were those in
Safe’’ order enacted on March 24, 2020, where transmission risk is higher. food/agriculture (39% increase),
limited construction to only critical Steinberg et al. (August 7, 2020) transportation/logistics (31% increase),
infrastructure and excluded commercial reported that attack rates (i.e., the facilities (23% increase), and
and residential work. One week later, number of individuals who are infected manufacturing (24% increase). Other
the Texas governor lifted the restriction in comparison to the total number at groups that also experienced excess,
for essential workers and allowed all risk) among production employees in statistically significant mortality
types of construction work to resume, the Cut (30.2%), Conversion (30.1%), compared to pre-pandemic periods were
while keeping the order in place for and Harvest (29.4%) departments of a health or emergency workers (17%
other workers. The authors found that meat processing plant (where spacing increase), retail workers (21% increase),
resuming construction during the between employees is less than 6 feet) and government and community
shelter-in-place order led to an increase were double that of salaried employees workers (17% increase). The study
in community transmission, an increase (14.8%) whose workstations had been authors concluded that certain
in hospitalizations among community modified to increase physical distancing occupational sectors were impacted
members, and an increase in from others. disproportionally by mortality during
hospitalizations of construction Waltenburg et al. (January, 2021) also the pandemic and that essential work
workers. By mid-July, Austin Public evaluated COVID–19 incidence in food conducted in-person is a likely avenue
Health identified at least 42 clusters (not manufacturing and agricultural settings of infection transmission.
defined) of COVID–19 cases in the (e.g., manufacturing or farming Hawkins et al. (January 10, 2021)
construction industry; 515 individuals involving fruits, vegetables, dairy, baked examined death certificates of
were hospitalized for COVID–19 goods, eggs, prepared foods), as reported individuals who died in Massachusetts
illnesses acquired as part of these in 30 states from March through May between March 1 and July 31, 2020. An
clusters, and 77 of those reported 2020. In food manufacturing and age-adjusted mortality rate of 16.4 per
working in construction. The study farming of fruits, vegetables, dairy, and 100,000 employees was determined
found that construction workers had a other items, 742 workplaces were from 555 death certificates that had
nearly 5-fold increased risk of affected, including 8,978 infections and useable occupation information.
hospitalization in central Texas 55 fatalities. For states that reported Employees in 11 occupational groups
compared with workers in other total numbers of employees, the had particularly high mortality rates:
occupations. The authors’ model proportion of employees who developed healthcare support; transportation and
predicted that allowing unrestricted COVID–19 in each state ranged from 2.0 material moving; food preparation and
construction work would be associated to 43.5%. For states that reported at serving; building and grounds cleaning
least one death, the percentages of and maintenance; production,
with an increase in COVID–19
deaths among cases ranged from 0.1 to construction and extraction;
hospitalization rates from 0.38 per 1,000
3.8%. installation/maintenance/repair;
residents to 1.5 per 1,000 residents Porter et al. (April 30, 2021) reported protective services; personal care
overall, and from 0.22 per 1,000 that 13 COVID–19 outbreaks occurred at services; arts/design/entertainment;
construction workers to 9.3 per 1,000 Alaska seafood processing facilities and sports/media; and community and
construction workers for the vessels (both of which were described as social services. The study authors noted
construction industry specifically. The high density workplaces) during the that occupational groups expected to
authors concluded that stringent Summer and early Fall of 2020. The 13 have frequent contact with sick people,
workplace safety measures could outbreaks involved 539 COVID–19 close contact with the public, and jobs
significantly mitigate risks related to cases, with 2–168 cases per outbreak. that are not practical to do from home
COVID–19 in the industry. Attack rates in facilities and offshore had particularly elevated mortality
The meat packing and processing vessels ranged from less than 5% to rates.
industries and related agricultural and 75%. Outbreaks were also reported in
food processing sectors have also been entry quarantine groups. Because of b. Healthcare Workers
impacted by COVID–19. Waltenburg et these outbreaks, it was determined that As explained in the Healthcare ETS,
al. (January, 2021) reported COVID–19 vaccination of these essential workers is COVID–19 presents a grave danger to
cases in employees from meat and important and requirements for COVID– workers in all U.S. healthcare settings
poultry processing facilities in 31 states 19 prevention were updated to include where people with COVID–19 are
from March 1 through May 31, 2020. As smaller quarantine groups, serial testing, reasonably expected to be present (86
reported in Table 2 of that report, 28,364 and testing before transfers from one FR 32381). Healthcare settings covered
employees in those facilities were facility or vessel to another. by the Healthcare ETS primarily include
confirmed to have COVID–19 by Finally, two published studies settings where people with suspected or
laboratory testing and 132 died. Among analyzed death records to determine confirmed COVID–19 are treated,
the 20 states that reported total numbers how mortality rates among individuals exacerbating the risk present in most
of employees, 11.4% of the workers in various types of workplaces had workplaces. To control the higher level
were diagnosed with COVID–19 (with a changed during the pandemic. Chen et of risk in those settings, OSHA
range of 3.1 to 27.7% of workers in al. (June 4, 2021) analyzed records of determined that a suite of workplace
individual states). For states that deaths occurring on or after January 1, controls was necessary to protect all
reported at least one COVID–19-related 2016 in California and found that employees, whether they are vaccinated
death, the percentages of employees mortality rates in working aged adults or unvaccinated. As explained further
App. 15
61416 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
below, OSHA now finds that first responders, and other frontline Delta variant in healthcare workers was
unvaccinated healthcare workers in workers in eight U.S. locations in six approximately 88–91%, suggesting how
healthcare settings not covered by the states from December 14, 2020 through much more extensive the outbreak
Healthcare ETS are also at grave danger August 14, 2021 revealed 194 infections could have been if a high percentage of
from exposure to SARS–CoV–2, just like in 4,136 unvaccinated participants healthcare workers were not fully
unvaccinated workers in other (89.7% symptomatic) and 34 infections vaccinated.
industries. Data continue to be collected in 2,976 fully vaccinated participants
In the UK, a Delta variant infection in
and reported for healthcare workers, (80.6% symptomatic) (Fowlkes et al.,
a healthcare worker resulted in an
and a small number of peer-reviewed August 27, 2021). During time periods
outbreak in a care home that affected 16
studies demonstrate the potential when the Delta variant represented
impact of the Delta variant on more than 50% of viruses sequenced, 19 of 21 residents and 8 of 21 staff
healthcare workers. infections were detected in 488 (Williams et al., July 8, 2021). One staff
CDC continues to provide updates for unvaccinated participants (94.7% member was hospitalized. Attack rates
COVID–19 cases and deaths among symptomatic) and 24 infections were were 35.7% in staff who were partially
healthcare personnel. However, detected in 2,352 vaccinated vaccinated (i.e., received their second
information on healthcare personnel participants (75% symptomatic). dose of vaccine on the day that the
status continues to be reported for only Monthly COVID–19 cases in index case was diagnosed with COVID–
a fraction (18.91%) of total reported healthcare workers were reported 19 or had only received one vaccine
cases, and death status was reported for during the period from March 1 to July dose) and 40% in staff who were not
only 82.16% of healthcare personnel 31, 2021 at the University of California vaccinated.
cases as of October 18, 2021 (CDC, San Diego (UCSD) health system, which Recent news stories demonstrate that
October 18, 2021—Healthcare is a healthcare provider that includes outbreaks affecting staff members are
Personnel). Given incomplete reporting, primary care services such as family still occurring in U.S. healthcare
the data from this source represent only medicine and pediatrics (Keehner et al., facilities. An outbreak that began in
a fraction of actual healthcare cases and September 1, 2021; UCSD, 2021). During August, 2021 at a Washington State
deaths. Nevertheless, CDC reported that time period, a total of 227 health nursing center resulted in infections in
666,707 healthcare personnel cases care workers tested positive for COVID– 22 staff members and 52 residents. In an
among the 6,754,306 reported cases that 19. One hundred and nine of 130 fully
unrelated outbreak, a nursing facility in
included information on healthcare vaccinated workers who tested positive
Hawaii reported infections in 24
personnel status (9.9%) and 2,229 (83.8%) were symptomatic and 80 of 90
employees and 54 patients (Wingate,
fatalities among the 547,769 cases that unvaccinated workers (88.9%) were
included death status (0.4%) for symptomatic; one unvaccinated person September 24, 2021). Vaccination rates
healthcare employees as of October 18, was hospitalized for COVID–19 were reported at 64.5% of residents and
2021. This is a 26% increase in the symptoms. By July of 2021, after the end 37.1% of staff in the Washington State
number of cases and a 27% increase in of California’s mask mandate on June 15 facility and 91% of staff and more than
the number of deaths since the May 24, and after the Delta variant became 80% of patients at the Hawaii facility.
2021 data reported in the ETS (CDC, dominant, the number of cases detected COVID–19 cases were also observed
October 18, 2021—Healthcare dramatically increased; the Delta variant in staff at ambulatory care settings prior
Personnel). The Delta variant is likely accounted for more than 95% of SARS– to emergence of the Delta variant. Over
responsible for the majority of those CoV–2 viruses sequenced by the end of an 11-week period beginning on March
deaths. No healthcare worker deaths that month. During July of 2021, 20, 2020, 254 tests for SARS–CoV–2
were reported by CDC during the weeks symptomatic infections were detected in were performed on employees who had
of May 30 through June 13, 2021; 94 of 16,492 fully vaccinated workers potential exposures at an outpatient
however, as the Delta variant’s and 31 of 1,895 unvaccinated workers. urology center in New York State
prevalence rose after June 20, healthcare Attack rates in July of 2021 were 5.7 per (Kapoor et al., 2020). Positive test rates
worker deaths began increasing; they 1,000 fully vaccinated workers and 16.4 in employees correlated with rates in
peaked during the period of August 15 per 1,000 unvaccinated workers. New York State, declining over time,
through September 12, 2021, when 34 to In Finland, a Delta variant infection from 26.1% in the early stage to 7.3%
36 healthcare worker deaths were from a hospitalized patient spread in the late stage of the study. According
reported per week (CDC October 18, throughout the hospital and to three
to study authors, the positive test results
2021—Healthcare Personnel, Deaths by primary care facilities, infecting 103
coincided with the implementation of
Week). Independent reporting by Kaiser individuals, including 45 healthcare
infection control procedures (e.g.,
Health News and The Guardian reported workers (Hetemäki et al., July 29, 2021).
Twenty-six of the healthcare workers symptom screening, masking,
more than 3,600 fatalities in health care
were infected at the hospital and 19 distancing, and hygiene). Positivity rates
workers as of April 2021 (Spencer and
were infected at primary care facilities. were similar in administrative and
Jewett, April 8, 2021). That number is
expected to be higher at this time since The affected health care workers clinical staff and the study authors
the earlier figure did not include the included 28 with direct patient contact concluded that ‘‘administrative staff in
most recent 5 months of the pandemic, (11 who were not fully vaccinated), 8 an outpatient setting were equally—if
which includes the period of Delta unvaccinated healthcare worker not more—vulnerable to SARS–CoV–2
variant predominance. students, and 9 other staff, including transmission when compared with
Published studies also demonstrate hospital cleaners and secretaries (of clinical staff who were more directly
that healthcare workers, especially those whom 6 were not fully vaccinated). exposed to patients.’’ The study authors
who are unvaccinated, remain at risk of According to study authors, ‘‘There was speculated that possible reasons for the
being infected with SARS–CoV–2 (see high vaccine coverage among permanent findings were that clinical staff were
Section III.A.IV. Vaccines Effectively staff in the central hospital, but lower more familiar with PPE and that
Reduce Severe Health Outcomes from for HCW in primary healthcare administrative staff, especially in check-
and Transmission of SARS–CoV–2). facilities. . .’’ Study authors estimated in and check-out points, tend to work
Routine testing of health care personnel, that vaccine effectiveness against the close to each other.
App. 16
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61417
c. Conclusion for Employee Impact people, and has led to hospitalization of York found that effectiveness did not
The evidence described above individuals in numbers similar to those change from May 3 to July 25, 2021 as
provides examples of the impact that of the November 2020 to February 2021 the Alpha variant gave way to the Delta
exposures from SARS–CoV–2, including surge. These changes in characteristics variant (91.9–96.2% range; Rosenberg et
those involving the Delta variant, have have provided a clearer realization of al., August 27, 2021). Grannis et al. used
had on employees in general industry, the continuing capacity for SARS–CoV– data from 187 hospitals in nine states
agriculture, construction, maritime, and 2 to present a grave danger to workers. from June to August 2021 to evaluate
healthcare settings. It demonstrates that However, it is well evident that even the efficacy of vaccines against
SARS–CoV–2 has spread to employees given these changed characteristics of hospitalization when Delta had emerged
in these industries and, in many cases, Delta, serious disease and death as the predominant variant causing
infection was linked to exposure to continue to occur overwhelmingly in SARS–CoV–2 infections (September 17,
infected persons at the worksite (WSDH, unvaccinated individuals while the 2021). This study found that vaccines
September 8, 2021; OHA, September 1, vaccinated are afforded great were 89% effective at preventing
2021; TDH, September 8, 2021; protection.13 hospitalization in individuals aged 18 to
NCDHHS, August 30, 2021; Hawaii 74. Similarly, vaccines were also found
a. Impact of Vaccination on Severe
State, August 19, 2021; Pray et al., to be 89% effective in preventing
Health Outcomes
January 29, 2021; Sami et al., April 9, hospitalization in a study collecting
There are currently three vaccines data from five Veteran Affairs Medical
2021; Suhs et al., July 23, 2021; Gold et that are approved or authorized for the
al., February 26, 2021; Porter et al., Centers from July 1 to August 6, 2021,
prevention of COVID–19 in the U.S.: a time when most transmission was
April 30, 2021; Hetemäki et al., July 29, The Pfizer-BioNTech COVID–19 vaccine
2021; Williams et al., July 8, 2021). The attributed to the Delta variant (Bajema et
(FDA approved for ages 16 and above; al., September 10, 2021).
documentation of so many workplace authorized for ages 12 and above), the Two other studies found that,
clusters suggests that exposures to FDA-authorized Moderna COVID–19 although the level of protection
SARS–CoV–2 occur regularly in vaccine (authorized for ages 18 and provided by vaccination has decreased
workplaces where employees come into above), and the FDA-authorized Janssen somewhat with the emergence of the
contact with others. This prevalence of COVID–19 vaccine (also known as the Delta variant, vaccines continue to
clusters, combined with some evidence Johnson & Johnson vaccine; authorized provide high levels of protection against
that many infections occurred within for ages 18 and above.) Pfizer-BioNTech hospitalization. In a U.S. study,
the 14-day incubation period for SARS– and Moderna are mRNA vaccines that researchers found that while the
CoV–2 and that exposures to infected require two primary series doses Moderna and Janssen vaccines mostly
persons outside the workplace were administered three weeks and one maintained their effectiveness at
frequently ruled out, supports the month apart, respectively. Janssen is a preventing hospitalization (going from
proposition that exposures to and viral vector vaccine administered as a 93% to 92% after more than 120 days
transmission of SARS–CoV–2 occur single primary vaccination dose (CDC, post-vaccination and 71% to 68% after
frequently at work. Multiple studies September 15, 2021). The vaccines were more than 28 days post-vaccination,
demonstrate high rates of COVID shown to greatly exceed minimum respectively) from March to August
infections, illnesses, and fatalities in the efficacy thresholds in preventing 2021, the effectiveness of the Pfizer-
wide range of occupations that require COVID–19 in clinical trial participants BioNTech vaccine at preventing those
frequent or prolonged close contact with (FDA, December 11, 2020; FDA, severe outcomes decreased from 91% to
other people, indoor work, and work in December 18, 2020; FDA, February 26, 77% after more than 120 days post-
crowded and/or poorly ventilated areas 2021). Data from clinical trials for all vaccination (Self et al., September 17,
The large numbers of infected three vaccines and observational studies 2021). An Israeli study on infections
employees suggest that SARS–CoV–2 is for the two mRNA vaccines clearly documented between July 11 and July
likely to be present in a wide variety of establish that fully vaccinated persons 31, 2021 found a significant decrease in
workplaces, placing unvaccinated have a greatly reduced risk of SARS– vaccine efficacy for the Pfizer-BioNTech
workers at risk of serious and CoV–2 infection compared to vaccine against severe outcomes in
potentially fatal health effects. unvaccinated individuals. This includes relation to when an individual was
IV. Vaccines Effectively Reduce Severe severe infections requiring vaccinated, but the absolute difference
Health Outcomes From and hospitalization and those resulting in was much less than what was observed
Transmission of SARS–CoV–2 death. For more information about the in the U.S. study (e.g., 98% effective for
effectiveness of vaccines as of late 40–59 year olds vaccinated in March
During the course of the SARS–CoV– Spring 2021, see 86 FR 32397, which versus 94% effective for those in the
2 pandemic, different variants have OSHA hereby includes in the record for same age group who were vaccinated in
emerged with different characteristics this ETS.14 January) (Goldberg et al., August 30,
that better enable transmission and Vaccines remain highly effective 2021).
potentially cause more severe outcomes. against hospitalization and death. A Vaccines also remain extremely
However, vaccines remain very effective study evaluating vaccine effectiveness at effective at preventing death. A UK
at reducing the occurrence of COVID– preventing hospitalization among those study evaluated the effectiveness of the
19-related severe illness, disability and with SARS–CoV–2 infections in New Pfizer-BioNTech vaccine against death
death.12 The Delta variant is more and found it to be 96.3% effective
transmissible than previous variants, 13 While mild cases of COVID–19 are included in
against the Alpha strain and 95.2%
might cause more severe illness than the grave danger presented by COVID–19, as stated
in the Healthcare ETS (see 86 FR 32382), OSHA is
protective against the Delta strain
previous variants in unvaccinated focusing on the most severe health effects, i.e., cases (Andrews et al., September 21, 2021).
requiring hospitalization and cases resulting in Two Israeli studies, Haas et al. and
12 A discussion of vaccination rates, as well as death, in this new rulemaking effort in order to Saciuk et al., performed during time
OSHA’s rationale for why vaccination is a critical prevent the gravest of consequences to workers.
means of protecting workers from the grave danger 14 This adoption includes the citations in the
periods where Alpha was predominant,
described in this section, can be found in Need for referenced section of the Healthcare ETS, which are found the Pfizer-BioNTech vaccine to be
the ETS (Section III.B. of this preamble). also included in the docket for this ETS. 96.7% and 91.1% effective,
App. 17
61418 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
respectively, against death (Haas et al., variant was predominant in Los Angeles (de Gier et al., August 5, 2021).
May 15, 2021; Saciuk et al., June 25, county (Griffin et al., August 27, 2021). Additionally, a study from the UK
2021). A California study found that the However, the level of protection had found that household transmission
Moderna vaccine was 97.9% effective fallen to a factor of 4.9 by July 25, 2021, decreased by as much as 50% when the
against death (Bruxvoort et al., when Delta made up 88% of infections infected individual was vaccinated
September 2, 2021). A study on patients in the county. The findings from this (Harris et al., June 23, 2021).
served by the Veterans Health study indicate that while vaccines More recent research suggests that the
Administration found that Pfizer- maintain robust protection against Delta variant may have reduced the
BioNTech and Moderna vaccines severe outcomes, protection against level of protection vaccination affords
provided 99% effectiveness against infection has fallen with the increased against transmission of the virus to
death (Young-Xu et al., July 14, 2021). circulation of the Delta variant. A others, but still significantly reduces
The risks of hospitalization and death broader study using data from 13 U.S. transmission risk in comparison to
appear to have increased for jurisdictions had similar findings, infected unvaccinated individuals. A
unvaccinated individuals since the observing that the protection vaccines UK study found that fully vaccinated
Delta variant became a common source afforded against infection decreased individuals infected by the Delta variant
of infections. A study of Los Angeles from a factor of 11.1 (i.e., vaccinated are able to transmit the virus to both
County SARS–CoV–2 infections found people were 11.1 times less likely than vaccinated and, to a greater degree,
that vaccinations reduced unvaccinated people to become unvaccinated persons (Singanayagam et
hospitalization risk by a factor of 10 on infected) between April 4 and June 19, al., September 6, 2021). Still, the rate at
May 1, 2021, when the Alpha variant 2021, to a factor of 4.6 between June 20 which transmission to unvaccinated
was dominant, but that the risk of and July 17, 2021 (Scobie et al., individuals occurred was nearly double
hospitalization was even more greatly September 17, 2021). An additional the rate of transmission to vaccinated
reduced (by a factor of 29.2) on July 25, study noted, however, that the decrease individuals (35.7% compared to 19.7%).
2021, when the Delta variant was in vaccine protectiveness against Similarly, Eyre et al., (September 29,
dominant (Griffin et al., August 27, symptomatic infection from the Delta 2021) found that during the
2021). This difference suggests both that variant could be due to the waning of predominance of Alpha, full vaccination
vaccines continue to provide a high immunity specifically in older with the Pfizer-BioNTech vaccines
level of protection against disease that populations. Andrews et al. (September resulted in a significant reduction in
results in hospitalization and that risk 21, 2021) found that while the Pfizer- transmission to others (an adjusted
has increased for those who are BioNTech vaccine effectiveness Odds Ratio (aOR) of 0.18, meaning that
unvaccinated. Similar increased risk for decreased from 94.1% to 67.4% in those being unvaccinated increased the odds
unvaccinated individuals was reported 65 years old and older, vaccine of transmission by over five times). With
in a study that evaluated hospitalization effectiveness for those 40 to 64 years old the rise of the Delta variant, that
and death data from 13 U.S. only decreased from 92.9% to 80.6%. reduction in transmission to others was
jurisdictions between June 20 and July less than with the Alpha variant, but
17, 2021, a period when the Delta While infections themselves do not still significantly more than for
variant gained prominence (Scobie et normally result in serious illness for unvaccinated individuals (aOR of 0.35,
al., September 17, 2021). For those who are vaccinated, evidence meaning that being unvaccinated
unvaccinated 18 to 49 year olds, the risk shows that vaccinated individuals who increased the odds of transmission by
of hospitalization was 15.2 times become infected with the Delta variant almost three times).
greater, and the risk of death was 17.2 can transmit the disease more easily to The greater ability for vaccinated
times greater, than the risks for others than with previous variants. This individuals to transmit the Delta variant
vaccinated people in the same age development poses a great concern for of SARS–CoV–2 to others (compared to
range. For unvaccinated 50 to 64 year the unvaccinated, who generally do not previous variants) appears to be linked
olds, the risk of hospitalization was 10.9 have the protections against severe to the generation of similar viral loads
times greater, and the risk of death was outcomes that vaccination affords. (as estimated by Ct threshold) in the
17.9 times greater, than for those who Before Delta, vaccinated individuals vaccinated compared to the
are vaccinated. These studies illustrate were shown to have lower estimated unvaccinated (Ct threshold is the
that vaccination is an extremely viral loads when infected than those number of RT–PCR cycles that need to
effective control measure to minimize who were unvaccinated, which be run in order to amplify the RNA
severe outcomes resulting from Delta suggested that infected vaccinated enough to be detected—fewer cycles
variant infections. individuals were likely not a major means a greater initial amount of virus
concern for transmission (Levine- was collected) (Singanayagam et al.,
b. Impact of Vaccination on Infection Tiefenbrun et al., March 29, 2021). September 6, 2021). This observation
and Transmission Transmission studies prior to the has been made in several studies. A
Vaccines continue to provide robust emergence of Delta appear to bear this study from Israel observed that viral
protection for vaccinated individuals out. A Scottish study performed during loads among those infected with the
against SARS–CoV–2 infections, even a time period when the Alpha variant Delta variant were only decreased in
though several studies indicate that was predominant in the region, showed people who had been vaccinated
vaccine efficacy against infection may that a fully vaccinated individual was recently (within the past two months) or
have decreased somewhat with the 3.2 times less likely than an in those who had recently received a
emergence of the Delta variant (Fowlkes unvaccinated individual to transmit the booster dose (Levine-Tiefenbrun et al.,
et al., August 27, 2021; Rosenberg et al., virus to unvaccinated family members September 1, 2021). In a study of SARS–
August 27, 2021; Nanduri et al., August (Shah et al., September 10, 2021; CoV–2 infections in Los Angeles
27, 2021; Seppala et al., September 2, supplementary appendix). A County, performed when the Delta
2021; Bernal et al., August 12, 2021). population-based study from the variant was predominant, vaccination
For example, vaccination was observed Netherlands found that vaccination status did not appear to affect the
to reduce the risk of infection by a factor decreased secondary transmission to estimated viral loads, suggesting that
of 8.4 on May 1, 2021, when the Alpha household members from 31% to 11% infected individuals who are vaccinated
App. 18
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61419
may be just as likely to transmit the economy are facing a grave danger of exposure to SARS–CoV–2 at work,
virus (Griffin et al., August 27, 2021). severe health effects or death from because their workplaces typically do
Additionally, estimated viral loads did exposure to SARS–CoV–2. Fully not include any of the characteristics
not appear to be significantly different vaccinated workers are not included in that normally enable transmission to
with respect to vaccination status in a this grave danger finding because, as occur (e.g., indoors, lack of ventilation,
Wisconsin study (Riemersma et al., July described throughout this section, those crowding). Bulfone et al. attributed the
31, 2021). Regardless of viral loads in who are fully vaccinated are much lower risk of transmission in outdoor
vaccinated and unvaccinated better protected from the effects of settings (i.e., open air or structures with
individuals, the fact remains clear that SARS–CoV–2 and, in particular, the one wall) to increased ventilation with
unvaccinated people pose a higher risk most severe effects, than are those who fresh air and a greater ability to
of transmission to others than are unvaccinated.15 Beyond that, maintain physical distancing (November
vaccinated people, simply because they OSHA’s grave danger determination 29, 2020). While the best available
are much more likely to get COVID–19 exempts several categories of workers evidence firmly establishes a grave
in the first place. based on characteristics of their work or danger in indoor settings, the CDC has
These studies, however, appear to workplace: (1) Workers who do not stated that the risk of outdoor
overstate increases in transmission risk report to a workplace where other transmission is ‘‘low’’ (CDC, September
from vaccinated individuals related to individuals are present or who telework 1, 2021) and OSHA is unable to
the Delta variant. From May to July from home; and (2) workers who establish a grave danger in outdoor
2021, UK researchers tested individuals perform their work exclusively settings from exposure during normal
at random to better characterize viral outdoors. The basis for these work activities.
load estimates in people with exemptions is explained below. In this OSHA recognizes that outdoor
asymptomatic as well as symptomatic section, OSHA also addresses the basis transmission has been identified in a
infections; they found that vaccination for OSHA’s grave danger finding for few specific incidents (e.g., 2 of 7,324
was associated with a significantly workers who are unvaccinated yet had cases, Qian et al., October 27, 2020).
lower estimated viral load (Elliott et al., a prior COVID–19 infection, and However, general reviews of
September 10, 2021). This more explains the Agency’s more nuanced transmission studies that include large-
comprehensive study (i.e., Elliott et al., grave danger finding in the healthcare scale and high-density outdoor
September 10, 2021) may have been able industry. gatherings indicate that indoor
to better characterize the course of transmission overwhelmingly is
infection and to incorporate vaccinated a. Employees Who Telework and
Employees Who Do Not Report to a responsible for SARS–CoV–2
individuals whose viral loads were
Workplace Where Other People Are transmission. Additionally, the lack of
decreasing quickly. The findings in
Present. evidence tied to specific case studies
Elliott et al. are consistent with studies
illustrating outdoor transmission in
observing that viral load may fall more Employees who report to workplaces comparison to the bevy of case studies
quickly in vaccinated individuals, where no other people are present face on indoor transmission makes it
resulting in a shorter infectious period no grave danger from occupational difficult to support a conclusion that
and possibly fewer transmission events exposure to COVID–19 because such outdoor transmission rises to the level
(Chia et al., July 31, 2021; Eyre et al., exposure requires the presence of other of a grave danger.
September 29, 2021). people. For those who work from their Bulfone et al. reviewed a collection of
c. Conclusion for the Impact of Vaccines homes, or from workplaces where no SARS–CoV–2 studies that evaluated
other people are present (such as a infections in outdoor and indoor
The studies discussed above indicate remote worksite), the chances of being
that vaccines continue to effectively settings (November 29, 2020), and found
exposed to SARS–CoV–2 through a that transmission is significantly less
protect vaccinated individuals against work activity are negligible. Therefore,
SARS–CoV–2 infections, while the risk likely to occur in outdoor settings than
OSHA is exempting those workers who in indoor settings. The studies overall
of infection, hospitalization, and death do not come into contact with others for
increased among unvaccinated people found that the risk of outdoor
work purposes from its grave danger transmission was less than 10% of the
as the Delta variant became finding as well as the scope of the ETS
predominant in the U.S. The Delta risk of transmission in indoor settings,
(for more information, see the Summary with three of the studies concluding risk
variant is even more dangerous to and Explanation for Scope and
unvaccinated individuals than previous was 5% or less of the risk of
Application, Section VI.B. of this transmission in indoor settings. While
variants because of the higher preamble).
transmission potential from both acknowledging significant gaps in
unvaccinated and vaccinated people. b. Employees Who Work Exclusively knowledge, the authors of a different
Because unvaccinated individuals are at Outside study suggested that increases in
much higher risk of severe health transmission related to large events such
Employees who work exclusively
outcomes from infection with SARS– as the Sturgis motorcycle rally may be
outside face a much lower risk of
CoV–2, and also pose a greater related to lack of local efforts to prevent
transmission risk to those around them, 15 The exclusion of vaccinated workers from this transmission indoors (e.g., requiring the
it is critical to assure that as many grave danger finding does not mean that vaccinated wearing of masks, closing indoor
people as possible are fully vaccinated workers face no risk from exposure to SARS–CoV– dining), rather than the outdoor setting
2. The best available evidence clearly shows that for the rally (Dave et al., December 2,
in order to prevent transmission at vaccination provides great protection from infection
work. and severe outcomes, but breakthrough infections
2020). In contrast, transmission rates
do occur and vaccinated individuals can still did not increase as expected following
V. Coverage of OSHA’s Grave Danger transmit the virus to others. In some cases, the level the Summer 2020 protests on racial
Finding of risk to vaccinated workers may even rise to the injustice. This outcome was attributed,
level of a significant risk, the standard OSHA must
Based on the information discussed meet for promulgation of a permanent standard
in part, to participants having been less
above, OSHA finds that many under section 6(b)(5) of the OSH Act (29 U.S.C. likely to enter indoor commercial
unvaccinated workers across the U.S. 655(b)(5)). establishments.
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61420 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
Weed and Foad (September 10, 2020) Washington State. The researchers players who had SARS–CoV–2; one
found that transmission of SARS–CoV– found that 28% of workers with match involved a team where 44% of
2 related to large scale outdoor predominantly indoor tasks where they the players were infected. Video
gatherings could be largely attributed to were unable to maintain physical analysis was used to determine the type
individual behaviors related to that distance were infected, compared to 6% of contact between players, such as
event, such as communal travel and of workers who performed contact to face or hand slaps. None of
indoor congregation at other facilities predominantly outdoors tasks in the the existing cases were associated with
(e.g., restaurants, shared orchards. Conversely, a study on on-field play and no secondary
accommodations), rather than to the farmworkers in Monterey County, transmission from on-the-field contacts
time spent outdoors at those gatherings. California found a significant was observed. Jones et al. (February 11,
Similarly, a Public Health England correlation between evidence of 2021), evaluated four rugby Super
evaluation of the literature on SARS– infection and individuals who worked League matches involving eight players
CoV–2 and surrogate respiratory viruses in the fields as opposed to indoor work who were found to be infected with
(December 18, 2020) also concluded that (Mora et al., September 15, 2021). The SARS–CoV–2. Using video footage and
when transmission does occur at paper noted that infections were global positioning data, the researchers
outdoor events, outdoor activities were predominant in individuals who lived were able to identify 28 players as high-
mixed with indoor setting use. Public in crowded conditions, commuted risk contacts with the infected players.
Health England concluded that the vast together to the fields, and spoke at home These high-risk players together had as
majority of transmission happens in in indigenous languages, which is many as 32 tackles and were within two
indoor settings, with very little evidence important as written health messages meters of infected players as often as
for outdoor transmission. are often not available in all worker 121 times during the four matches. Of
A systemic review of SARS–CoV–2 languages. These papers cannot identify the 28 players noted as high-risk
clusters identified 201 events through where or when infections occurred in contacts, one became infected with
May 26, 2020 (Leclerc et al., April 28, order to discern causation. The SARS–CoV–2. However, researchers
2021), only 4 of which occurred at associations observed may indicate that determined that the transmission
predominantly outdoor settings. For SARS–CoV–2 infections may be more resulted from internal team outbreaks
those 4 clusters, the authors noted that related to aspects related to indoor and not from exposure on the field.
they were not able to evaluate specific exposures outside of the work activities OSHA acknowledges that the risk of
transmission events and attributed it to (e.g., crowded living conditions) or transmission of SARS–CoV–2 in
local health agencies being potentially overlooked indoor aspects outdoor settings is not zero, and that
overwhelmed by the pandemic. OSHA connected to outdoor work (e.g., shared there may be some low risk to workers
notes that the designations of settings in commuting). performing general tasks exclusively in
this study are somewhat generic, as Several studies discussed below in outdoor settings. However, where
outdoor construction sites will often more detail have evaluated outdoors on- studies have been able to differentiate
have indoor locations, such as mobile field transmission from infected between indoor and outdoor exposures,
offices, or locations with reduced participants during football, soccer, and they indicate that indoor exposures are
airflow, such as areas with a roof or rugby matches. These events include the much more significant drivers of
ceiling and two or more walls. repeated close physical contact between SARS–CoV–2 infections. Therefore, the
Regardless, this study illustrates the players, without PPE or physical best available evidence at this time does
comparable abundance of evidence distancing, over the course of fairly long not provide OSHA with the information
available to evaluate SARS–CoV–2 events, with increased exertion leading needed to establish SARS–CoV–2 as a
transmission in indoor settings versus to greater respiratory effort and grave danger for general work activities
outdoor settings. production of respiratory droplets. in outdoor settings (see Int’l Union,
Cevik et al. (August 1, 2021) reviewed These events also include opposing United Auto., Aerospace, & Agr.
studies on the transmission dynamics of cohorts who only interact during on- Implement Workers of Am., UAW, 590
SARS–CoV–2 infections from large field activities. Therefore, these studies F. Supp. at 755–56, describing a ‘‘grave
scale, contact-tracing studies. The provide some evidence for the low danger’’ as a risk that is more than
authors recommended that, based on the likelihood of outdoor transmission in ‘‘significant’’). Therefore, OSHA has
evidence that outdoor transmission other workplace activities greatly excluded employees who work
dynamics resulted in significantly fewer impacted by the pandemic, such as in exclusively outdoors from the scope of
infections than in indoor settings, construction. this ETS (see the Summary and
public health entities should greatly Mack et al. (January 29, 2021) detailed Explanation for Scope and Application,
encourage use of outdoor settings. The the National Football League’s complex Section VI.B. of this preamble).
researchers highlighted a study by program to assess and prevent
Nishiura et al. (April 16, 2020), who transmission, which included devices c. Employees in Healthcare
evaluated 110 cases in Japan at the that recorded distance and duration of Because OSHA issued a separate
beginning of the pandemic and found interactions with others, for the purpose grave danger determination several
that outdoor settings reduced of improving identification of months ago for some healthcare
transmission risk by 18.7 times and individuals with high-risk exposures. workers, some explanation of how its
reduced the risk of super-spreader Although 329 positive cases were current finding applies to healthcare
events by 32.5 times. identified among roughly 11,400 players workers is necessary. In June 2021,
Agricultural workplace settings have and staff, there were no reported cases OSHA issued its Healthcare ETS (86 FR
experienced significant SARS–CoV–2 of on-field transmission by infected 32376) after determining that some
infections. However, transmission in players. The results led the NFL to focus healthcare workers faced a grave danger
these settings is difficult to characterize more on reducing transmission in of infection from SARS–CoV–2. This
because many jobs in this sector include indoor settings, including grave danger determination, along with
both outdoor and indoor activities. transportation. the protections of the Healthcare ETS,
Miller et al. (April 30, 2021) evaluated Egger et al. (March 18, 2021) reviewed applied to healthcare and healthcare
an outbreak among farmworkers in three soccer matches involving 18 support workers in settings where
App. 20
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61421
people with suspected or confirmed immunity to any infectious disease, antibodies in response to the virus)
cases of COVID–19 are treated, and was including SARS–CoV–2, is achieved would provide some measure of
based on the increased potential for through a complex response to exposure protection, but that these individuals
transmission of the virus in such by the immune system. This response would benefit from a vaccination
settings (see 86 FR 32411–32412). These consists of disease-specific antibody booster. This position appears to be
workers are currently covered by the production guided and augmented by validated by a study that compared the
protections of the Healthcare ETS (29 certain types of immune cells, such as reinfection rates of individuals in
CFR 1910.502). OSHA does not have T and B cells, which work together to Kentucky based on their post-recovery
data to demonstrate that unvaccinated neutralize or destroy the disease-causing vaccination status (Cavanaugh et al.,
workers in settings covered by the agent. Immune responses to viruses like August 13, 2021). Unvaccinated
Healthcare ETS face a grave danger from SARS–CoV–2 can be measured in individuals with previous infection
SARS–CoV–2 when the requirements of several ways. For instance, blood serum were found to be 2.3 times more likely
that standard are followed. However, if can be taken and exposed to specific to be reinfected than those who were
the Healthcare ETS were no longer in proteins found on the SARS–CoV–2 vaccinated after their prior infection.
effect, OSHA would consider the virus, in order to measure the presence These studies demonstrate not only that
workers who were covered by it, and of antibodies in the blood. Another those with milder infections may not be
who remain unvaccinated, to be at grave antibody test, the neutralization test, protected against future infection, but
danger for the reasons described in this measures the ability of the antibodies that it is difficult to tell, on an
ETS. present in a serum to neutralize individual level, which individuals
OSHA’s new finding of grave danger infectivity and prevent cells from being might have had prior infections that
applies to healthcare and healthcare infected. T cell immunity can be conveyed protection equivalent to that
support workers who are not covered by measured using techniques that target a provided by vaccination.
the Healthcare ETS, to the extent they specific biomolecule that is specific to A number of other studies indicate
remain unvaccinated. In this ETS, as SARS–CoV–2. that fully vaccinated individuals may be
discussed in this section, OSHA has
A considerable number of individuals better protected against future infection
made a broader determination of grave
who were previously infected with than those with previous infections. A
danger that applies to most
SARS–CoV–2 do not appear to have study in Massachusetts concluded that
unvaccinated workers, regardless of
acquired effective immunity to the virus the immunity conveyed from a previous
industry. OSHA’s current finding of
(Psichogiou et al., September 13, 2021; SARS–CoV–2 infection was effectively
grave danger supporting this ETS does
not depend on whether a workplace is Wei et al., July 5, 2021; Cavanaugh et equivalent to the immunity of an
one where people with suspected or al., August 13, 2021). The level of uninfected individual who has had only
confirmed COVID–19 are expected to be protection afforded by infection- one dose of an mRNA vaccine
present. Therefore, the finding of grave induced immunity appears to depend (Naranbhai et al., October 13, 2021). The
danger applies to unvaccinated workers on the severity of individuals’ authors found that fully vaccinated
in healthcare settings that are not infections. In a study from Greece, individuals have an immune response
covered by 29 CFR 1910.502 to the same immunogenicity was compared between (i.e., antibodies and neutralization) well
extent it applies to unvaccinated healthcare workers who were above the levels observed in
workers in all other industry sectors. vaccinated with Pfizer-BioNTech and unvaccinated, previously-infected
unvaccinated patients who acquired a individuals. German researchers found
d. Employees Who Were Previously natural infection (Psichogiou et al., that individuals who were fully
Infected With SARS–CoV–2 September 13, 2021). The researchers vaccinated with Pfizer-BioNTech had a
OSHA has carefully evaluated the found that the immune response in significantly greater immune response
effectiveness of previous SARS–CoV–2 unvaccinated individuals correlated to (as measured by antibody levels) than
infections in providing protection the severity of their disease. Fully unvaccinated individuals who had
against reinfection. This section vaccinated healthcare workers had infections, concluding that vaccination
provides a detailed description of the immune responses (measured as would be needed for those unvaccinated
current scientific information in order to antibody levels specific to SARS–CoV– individuals to have similar protection
ascertain what the best available 2) that were 1.3 times greater than against infection (Herzberg et al., June
scientific evidence on this topic patients who had critical cases of 13, 2021). Similarly, a Dutch study
indicates regarding the risk to COVID–19 cases, 2.5 times greater than observed that vaccination greatly
individuals with previous COVID–19 patients who had moderate to severe improved the immune response (as
infections from exposure to SARS–CoV– cases, and 10.5 times greater than measured by antibodies and virus-
2. While the agency acknowledges that patients who had asymptomatic/mild specific T cells) of individuals who had
the science is evolving, OSHA finds that illnesses. Similarly, another study found recovered from COVID–19 (Geers et al.,
there is insufficient evidence to allow that 24.0% (1,742 of 7,256) of May 25, 2021). Planas et al. (August 12,
the agency to consider infection- individuals who had a previous SARS– 2021) also noted that immune response
acquired immunity to allay the grave CoV–2 infection were seronegative (i.e., (as measured by neutralization) to the
danger of exposure to, and reinfection did not produce antibodies in response Alpha, Beta, and Delta (B.1.617.2)
from, SARS–CoV–2. to the virus), suggesting that the variants in unvaccinated, previously-
To determine whether employees previous infection provided insufficient infected individuals was considerably
with infection-induced immunity from protection against future infection (Wei less than the immune response in
SARS–CoV–2 (i.e., those who were et al., July 5, 2021). Individuals who individuals five weeks after their second
infected with SARS–CoV–2 but have not were seronegative were typically older, Pfizer-BioNTech dose. When
been vaccinated) face a grave danger, had lower viral burdens when infected, unvaccinated, previously-infected
OSHA reviewed the scientific evidence and were more likely to be individuals were vaccinated, their
on the protective effects of vaccine- asymptomatic. The authors posited that immune response (as measured by
induced SARS–CoV–2 immunity versus the immunity of those who were neutralization) increased by more than
infection-induced immunity. Individual seropositive (i.e., did produce an order of magnitude. Likewise, Wang
App. 21
61422 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
et al. (July 15, 2021) found that the the context of OSHA’s grave danger this population that is more vulnerable
immune response (as measured by inquiry, the implications of trying to to reinfection, in these studies,
neutralization) of those with previous apply investigative research undercuts their usefulness in OSHA’s
SARS–CoV–2 infection increased by methodology to clinical practice are grave danger analysis, because they may
more than an order of magnitude against even more challenging. The need for the overestimate the protectiveness of
Alpha (B.1.1.7), Beta (B.1.351), Iota development of standardized methods immunity acquired through infection.
(B.1.526), and Gamma (P.1) variants and criteria for establishing sufficient Several other studies in regions less
when they were vaccinated. These immunity preclude the application of known for their sampling approach than
studies show that infection-induced the studies’ findings to robust and Denmark also were heavily dependent
immunity may not equal the protection reliable clinical practice. These three on early, limited pandemic RT–PCR
afforded by vaccination and that rationales for OSHA’s finding are testing. An Austrian study found a
vaccination greatly improves the described in more detail below. roughly ten-fold decrease in reinfection
immune response of those who were Several epidemiological studies used in survivors of reported infections from
previously infected. previous RT–PCR positive cases to February to April 30, 2020 in
The aforementioned studies indicate define previous infections (Hansen et comparison with the general public
that immunity acquired through al., March 27, 2021; Pilz et al., February (Pilz et al., February 11, 2021). The
infection appears to be less protective 11, 2021; Vitale et al., May 28, 2021; authors noted that ‘‘infections in the
than vaccination. There are also a Pouwels et al., October 14, 2021; Braeye first wave are likely to have been far
number of epidemiological studies that et al., September 15, 2021; Hall et al., more common than the documented
provide some evidence that infection- April 17, 2021). RT–PCR tests, ones’’ and referred to their results as a
acquired immunity has the potential to particularly in the beginning of the ‘‘rough estimate.’’ Researchers at the
provide a significant level of protection pandemic, were given high priority to Cleveland Clinic also found a reduced
against reinfection. As OSHA discusses discern who seeking medical care was, rate of reinfection in those who had a
in greater detail below, these studies in fact, infected. For instance, the reported previous infection compared
suffer from methodological limitations progression of testing from medical with those with no prior infection
that render them inconclusive about the needs to more of a community (13.8% infection rate for those
level of immunity conferred by perspective is illustrated in Denmark previously uninfected and 4.9%
infection, and therefore OSHA is unable (Vrangbaek et al., April 29, 2021). infection rate for those previously
to establish that such immunity Denmark, considered one of the gold infected), but noted that testing was
eliminates grave danger. This standard countries for its limited in that the ‘‘Cleveland Clinic did
determination is based in three parts. comprehensive testing program, missed not test asymptomatic patients unless
First, the epidemiological literature five infections for every one it identified they were admitted to hospital or
OSHA reviewed generally suffers from in the spring of 2020 (Espenhaim et al., undergoing a procedure/surgery’’
selection bias to a degree that it serves August 22, 2021). Hansen et al. (March (Sheehan et al., March 15, 2021). These
as an unreliable basis on which to reach 27, 2021) depended greatly on these first criteria for testing create uncertainty in
a robust conclusion on whether surge infection definitions to determine determining the level of effectiveness
previous infection removes workers that survivors had protection of 80.5% previous infection provides against
from grave danger. In general, the effectiveness during the second surge in SARS–CoV–2 because many individuals
studies described below do not account Denmark from September through with asymptomatic infections would not
for people who had mild COVID–19 December, 2020. By only noting RT– have been tested. Similar issues are also
infections, leading to study findings PCR positives from the spring when found in studies on populations in Italy,
regarding the level of protection testing was limited and highly focused Belgium, and the UK (Vitale et al., May
afforded by prior infection that are not on health care needs, it seems apparent 28, 2021; Braeye et al., September 15,
generally applicable. Second, the tests that the study excluded many less 2021; Pouwels et al., October 14, 2021).
employed in the studies are being used severe cases (which are less likely to To avoid the well-known problems
in ways that they were not originally result in an effective immune response with RT–PCRs defining previous
designed to be employed. These tests against reinfection), leading to results infection, other studies have defined
are powerful tools, but there are that may suggest greater protection is previous infection as testing positive for
limitations to their use in determining if afforded by infection than in actuality. antibodies specific for SARS–CoV–2
a specific individual is, in fact, Even by December of 2020, it appears (Lumley et al., February 11, 2021; Abu-
protected from the grave danger of Denmark’s gold standard Raddad et al., April 28, 2021; Hall et al.,
SARS–CoV–2. Particularly problematic comprehensive testing approach was April 17, 2021). As noted above,
is the lack of established thresholds to only able to capture roughly half of all previous infection does not necessarily
determine full protection from infections. Similar systemic result in a seropositive outcome; one
reinfection or even a standardized undercounts have also been determined study indicated that nearly a quarter
methodology to determine infection to be true in the United States where (24%) of those infected with SARS–
severity or immune response. Thus, approximately three out of four CoV–2 subsequently showed no sign of
while these studies broadly establish infections have never been reported an immune response in SARS–CoV–2-
some increase in protectiveness against (CDC, July 27, 2021b). specific antibody testing (Wei et al., July
SARS–CoV–2 among the studied It is important to recognize that RT– 5, 2021). Therefore, studies only
populations, they as yet are unable to PCR testing was not implemented to considering seropositive individuals are
provide a reasonable degree of certainty find every infection, but was used in essence studying only the individuals
on whether the degree of protection instead to assist in determining when most likely to have protection from
afforded any particular individual from medical and community interventions reinfection. Lumley et al. (February 11,
their prior infection is sufficient to were necessary. Infections without 2021) found that those having a
eliminate the grave danger from symptoms or with mild symptoms likely seropositive response had almost an
reinfection (see Milne, et al., October 21, would not require medical intervention order of magnitude fewer infections
2021.) Third, while the research and, therefore, would likely not be (e.g., 0.11 adjusted incidence rate ratio).
methodology itself creates difficulties in identified via testing. The absence of Likewise, Abu-Raddad et al. (April 28,
App. 22
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61423
2021) found that seropositive individual basis. The studies discussed with a standardized dosing regime,
individuals were reinfected less (0.7%) above are based on tests that show only scientific inquiries likely will not be
during their study period in comparison whether a person was or was not able to identify most individuals who
to seronegative individuals (3.09%). In infected and provide no information were infected, the degree of disease
addition to the bias associated with about the severity of the infection. experienced for those with a confirmed
using antibodies to determine previous Because the studies are likely biased infection, and the immunity against
infection, the authors also noted that towards those who had a relatively reinfection. As of October 18, 2021,
there may have been issues with being serious infection, their findings cannot several RT–PCR assays have been
able to document cases with mild or no be generalized to all individuals with authorized without standardization or
symptoms. prior infections. assessment with respect to measuring
Hall et al. (April 17, 2021) cast a RT–PCR and antibody testing are disease severity (FDA, October 18,
wider net by defining previous infection powerful tools with many clinical and 2021). As noted above, the use of the Ct
to include both positive RT–PCR tests research applications. However, the threshold to approximate viral loads
and seropositivity. The researchers application of these tools cannot and infer disease severity is unreliable.
found that those who were considered determine what degree of protection a As the FDA notes, the same is true about
previously infected had an 84% lower particular individual has against SARS– antibody tests, which are considered to
risk of infection compared to those who CoV–2 without a great deal of additional be poor indicators for individuals to use
were unvaccinated with no record of study concerning thresholds to determine whether they are protected
infection. While the study does attempt establishing individual immunity. from reinfection (FDA, May 19, 2021).
to capture as many previously-infected Therefore, these tools are not yet able to There are many different SARS–CoV–2-
individuals as possible, this does not assist OSHA in making more nuanced specific antibody tests that focus on
actually address the weaknesses of each findings about which workers who had different specificity. Not only are the
method. Those with less severe COVID–19 previously are at grave outcomes of these tests not directly
infections were less likely to have danger. There is no established comparable to each other, but the
sought out or been able to get an RT– threshold to determine full protection specificity of these tests is not related to
PCR test during the first surge, which is from reinfection or a standardized any notion of protection against
when an overwhelming number of the methodology to determine infection reinfection. It can be reasonably said
previous infections were recorded in severity or immune response. Studies that a greater antibody response means
this study (March through May, 2020). use Ct threshold to approximate viral a greater likelihood of protection against
Additionally, the less severe infections loads and infer disease severity, but that infection, but, again, the science is not
that are most likely underrepresented in metric depends on many variables (e.g. clear what those thresholds are and
the study appear to be the ones that are time of collection during infection, whether a threshold would be
less likely to produce seropositivity. quality of collection, handling of comparable between laboratories. At
Shenai et al. (September 21, 2021) sample, specifics of the test protocol this point in time, even if OSHA
pooled several studies with the above and materials, precision in performing determined that some individuals with
issues and concluded that immunity the protocol) that are often of far less prior infections are not at grave danger
acquired through a previous infection importance when it is used as a crude from exposure to SARS–CoV–2, there is
from SARS–CoV–2 may be as protective diagnostic to determine the presence of no agreement on what indicators of
as, or more protective than, the an infection. In other words, it is infection might be sufficient to confer
immunity afforded by vaccination to an reasonable to say that the lower the Ct
this level of immunity or how a
individual without previous infection. count, the greater the likelihood that an
healthcare provider or employer could
However, authors of several of those individual is at a lower reinfection risk;
document that a certain level of
underlying studies used in the analysis however, the Ct count is greatly
immunity had been achieved.
noted that their studies were limited by dependent on the RT–PCR test used,
not having the capability to fully and how different laboratories may run Based on the best available evidence
account for asymptomatic infections that test, which cannot be discerned. described above, OSHA concludes that
(the aforementioned Lumley et al., July Similarly, research needs to be done to while some individuals who were
3, 2021; Gazit et al., August 25, 2021; better identify the minimum protective infected with SARS–CoV–2 may have
Shrestha et al., June 19, 2021). As noted threshold of anti-SARS–CoV–2 serum significant protection from subsequent
earlier, infection severity appears to be neutralizing antibodies (Milne et al., infections, the level of protection
correlated with the robustness of October 21, 2021). Thus, these studies afforded by infection may be
immunity acquired through that currently do not allow OSHA to significantly impacted by the severity of
infection, so the failure to account for determine, with a reasonable degree of the infection and some previously
asymptomatic infections may mean that certainty, how much protection infected individuals may have no future
this finding is related to the protection employees with prior infections have protection at all. In addition, given the
afforded by more severe disease. While against reinfection. limitations of the studies described
pooled analyses can be utilized to make Furthermore, while the research above, there is considerable uncertainty
powerful observations, those methodology itself raises challenges in as to whether any given individual is
observations are highly dependent upon making the grave danger determination, adequately protected against reinfection.
the underlying studies not sharing the the implications of trying to apply Furthermore, the level of protection, if
same methodological weakness which, investigative research methodology to any, provided by a given person’s
in this case, was the studies’ exclusion clinical practice are even more difficult. SARS–CoV–2 infection cannot be
of asymptomatic infections. The lack of standardized methods and ascertained based on currently-available
Moreover, while the evidence standardized measures for immunity testing methods. Therefore, OSHA finds
suggests that severe infection may preclude their application to robust and that the requirements of this ETS are
provide significant protection against reliable clinical practice. One major necessary to protect unvaccinated
reinfection in some cases (Milne et al., drawback discussed above is that, in individuals who had prior SARS–CoV–
October 21, 2021), the level of contrast to vaccine studies where 2 infections from the grave danger from
protection cannot be determined on an researchers know who was vaccinated exposure to SARS–CoV–2.
App. 23
61424 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
OSHA recognizes that its finding are more likely than those who are context, OSHA is confident in its
regarding infection-induced immunity vaccinated to be infected and transmit finding that exposure to SARS–CoV–2
is being made in an area of inquiry that the virus to others. Every workplace poses a grave danger to the employees
is currently on the ‘‘frontiers of SARS–CoV–2 exposure or transmission covered by this ETS.
scientific knowledge’’ (Indus. Union has the potential to cause severe illness The above analysis fully satisfies the
Dep’t, AFL–CIO v. Am. Petroleum Inst., or even death, particularly in OSH Act’s requirements for finding a
448 U.S. 607, 656 (1980)). For these unvaccinated workers. Taken together, grave danger. Although OSHA usually
reasons, OSHA finds that those who the severe health consequences of performs a quantitative risk assessment
have previously been infected with COVID–19 and the evidence of its based on extrapolations among exposure
SARS–CoV–2 and are not yet fully transmission in environments levels before promulgating a health
vaccinated are at grave danger from characteristic of the workplaces covered standard under section 6(b)(5) of the
SARS–CoV–2 exposure and that it is by this ETS demonstrate that exposure OSH Act (29 U.S.C. 655(b)(5)), that type
necessary to protect these workers via to SARS–CoV–2 represents a grave of analysis is not necessary in this
vaccination, or testing and the use of danger to unvaccinated employees in situation. OSHA has most often invoked
face coverings, under this standard. many workplaces throughout the section 6(b)(5) authority to regulate
OSHA will continue to follow country. exposures to chemical hazards
developments on this issue, however, The existence of a grave danger to involving much smaller populations,
and make appropriate adjustments to employees from SARS–CoV–2 is further many fewer cases, extrapolations from
this ETS if the evidence warrants. supported by the toll the pandemic has animal evidence, long-term exposure,
already taken on the nation as a whole and delayed effects. In those situations,
VI. Conclusion. and the number of workers who remain mathematical modelling is necessary to
OSHA finds that many employees in unvaccinated. Although OSHA cannot evaluate the extent of the risk at
the U.S. who are not fully vaccinated state with precision the total number of different exposure levels. The gravity of
against COVID–19 face a grave danger workers in our nation who have the danger presented by a disease with
from exposure to SARS–CoV–2 in the contracted COVID–19 at work and acute effects like COVID–19, on the
workplace. OSHA’s determination is became sick or died, COVID–19 has other hand, is made obvious by a
based on the severe health killed 723,205 people in the United straightforward count of deaths and
consequences of exposure to the virus, States as of October 18, 2021 (CDC, illnesses caused by the disease, which
including death; powerful lines of October 18, 2021—Cumulative US reach sums not seen in at least a
evidence demonstrating the Deaths). That death toll includes century. The evidence compiled above
transmissibility of the virus in the 131,478 people who were 18 to 64 years amply supports OSHA’s finding that
workplace; and the prevalence of old, prime working age (CDC, October SARS–CoV–2 presents a grave danger in
infections in employee populations. 18, 2021—Demographic Trends, Deaths American workplaces. In the context of
With respect to the grave health by Age Group). OSHA estimates that ordinary 6(b) rulemaking, the Supreme
consequences of exposure to SARS– there are over 26 million workers Court has said that the OSH Act is not
CoV–2, OSHA has found that regardless subject to the rule who remain a ‘‘mathematical straitjacket,’’ nor does
of where and how exposure occurs, unvaccinated at present and therefore it require the agency to support its
COVID–19 can result in death. Even for are in grave danger. As a result of this findings ‘‘with anything approaching
those who survive a SARS–CoV–2 ETS, the agency estimates that 72% of scientific certainty,’’ particularly when
infection, the virus can cause serious, them will be vaccinated (see OSHA, operating on the ‘‘frontiers of scientific
long-lasting, and potentially permanent October 2021c). knowledge’’ (Indus. Union Dep’t, AFL–
health effects. Serious cases of COVID– Current mortality data shows that CIO v. Am. Petroleum Inst., 448 U.S.
19 require hospitalization and dramatic unvaccinated people of working age 607, 655–56 (1980)). This is true a
medical interventions, and might leave have a 1 in 202 chance of dying when fortiori in the current national crisis,
employees with permanent and they contract COVID–19 (CDC, October where OSHA must act to ensure
disabling health effects. Both death and 18, 2021—Demographic Trends, Cases employees are adequately protected
serious cases of COVID–19 requiring by Age Group; Demographic Trends, from the hazard presented by the
hospitalization provide independent Deaths by Age Group). As of October 18, COVID–19 pandemic (see 29 U.S.C
bases for OSHA’s finding of grave 2021, close to 45 million people in the 655(c)(1)).The grave danger from SARS–
danger. The evidence is clear that the United States have been reported to CoV–2 represents the biggest threat to
safe and effective vaccines authorized have infections, and thousands of new employees in OSHA’s more than 50-year
and/or approved for use in the United cases were being identified daily (CDC, history. The threat applies to employees
States greatly reduce the likelihood of October 18, 2021—Daily Cases).One in in all sectors covered by OSHA,
these severe outcomes. 14 reported cases of COVID–19 in including general industry,
The best available evidence on the people ages 18 to 64 becomes severe and construction, maritime, agriculture, and
science of transmission of the virus requires hospitalization (CDC, October healthcare. Having made the
makes clear that SARS–CoV–2 is 18, 2021—Demographic Trends, Cases determination of grave danger, as well
transmissible from person to person in by Age; Total Hospitalizations, by Age). as the determination that an ETS is
shared workplace settings. The Moreover, public health officials agree necessary to protect employees from
likelihood of transmission can be that these numbers fail to show the full exposure to SARS–CoV–2 (see Need for
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Outbreak-COVID-19-Report-2021-09-01- (Qian et al., October 27, 2020) 17, 2021)
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Peterson-KFF Health System Tracker. 2021.07.31.21261387. (Riemersma et al., Shah ASV et al. (2021, September 10). Effect
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2 Delta VOC in Scotland: Demographics, specialties/primary-care/Pages/ Today. https://www.usatoday.com/story/
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397(10293): 2461–2462. doi:10.1016/ of stay for COVID–19 patients: Data- dozens/5848804001/. (Wingate,
s0140–6736(21)01358–1. (Sheikh et al., driven methods for forward planning. September 24, 2021)
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Shenai MB et al. (2021, September 21). doi.org/10.1186/s12879-021-06371-6. and effectiveness of mRNA COVID–19
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fully vaccinated persons: A systematic SARS–CoV–2 refinfection 1 year after 2021.06.14.21258906. (Young-Xu et al.,
review and pooled analysis. medRxiv primary infection in a population in July 14, 2021)
preprint. doi:10.1101/ Lombardy, Italy. JAMA Intern Med,
2021.09.12.21263461. (Shenai et al., 2021. doi:10.1001/ B. Need for the ETS
September 21, 2021) jamainternmed.2021.2959. (Vitale et al.,
This ETS is necessary to protect
Shrestha NK et al. (2021, June 19). Necessity May 28, 2021)
Vrangbaek K et al. (2021, April 29). unvaccinated workers from the risk of
of COVID–19 vaccination in previously
infected individuals. medRxiv preprint. Transition Measures: Testing. COVD–19 contracting COVID–19, including its
doi:10.1101/2021.06.01.21258176. Health System Response Monitor: more contagious variants, such as the
(Shrestha et al., June 19, 2021) Denmark. https:// B.1.617.2 (Delta), at work. The rule
Singanayagam A et al. (2021, September 6). www.covid19healthsystem.org/countries/ protects workers through the most
Community transmission and viral load denmark/livinghit.aspx?Section= effective and efficient workplace control
kinetics of SARS–CoV–2 Delta 1.5%20Testing&Type=Section. available: Vaccination. Additionally,
(B.1.617.2) variant in vaccinated and (Vrangbaek et al., April 29, 2021)
Wallace M et al. (2020, May 15). COVID–19 this ETS is necessary to protect workers
unvaccinated individuals. Lancet who remain unvaccinated through
preprint. doi:10.2139/ssrn.3918287. in Correctional and Detention
Facilities—United States, February– required regular testing, use of face
(Singanayagam et al., September 6, 2021)
Spencer J and and Jewett C. (2021, April 8). April 2020. MMWR 69: 587–590. http:// coverings, and removal of infected
Lost on the Frontline. 12 months of dx.doi.org/10.15585/mmwr.mm6919e1. employees from the workplace.
Trauma: More than 3,600 US health (Wallace et al., May 15, 2020)
Waltenburg MA et al. (2021, January). I. Events Leading to the ETS
workers died in COVID’s first year.
Coronavirus disease among workers in a This section describes the evolution
https://khn.org/news/article/us-health-
food processing, food manufacturing, of OSHA’s actions to protect employees
workers-deaths-covid-lost-on-the-
and agriculture workplaces. Emerg Infect
frontline/. (Spencer and Jewett, April 8,
Dis 27(1): 243–249. https:// from the grave danger posed by COVID–
2020) 19 and the agency’s reasons for issuing
wwwnc.cdc.gov/eid/article/27/1/20–
Steinberg J et al. (2020, August 7). COVID– 3821_article. (Waltenburg et al., January this ETS at this time.
19 Outbreak among employees at a meat 2021)
processing facility — South Dakota, Wang Z et al. (2021, July 15). Naturally
a. OSHA’s 2020 Actions Regarding
March–April 2020. MMWR Morb Mortal enhanced neutralizing breadth against COVID–19
Wkly Rep 69: 1015–1019. doi: http:// SARS_CoV–2 one year after infection.
dx.doi.org/10.15585/mmwr.mm6931a2.
Beginning in early 2020, OSHA began
Nature 595: 426–431. doi:10.1038/ to monitor the growing cases of the
(Steinberg et al., August 7, 2020) s41586–021–03696–9. (Wang et al., July
Suhs T et al. (2021, July 23). COVID–19 SARS–CoV–2 virus that were occurring
15, 2021)
Outbreak Associated with a Fitness Ward JA et al. (2021, June). COVID–19 cases
around the country. Because scientific
Center—Minnesota, September– among employees of U.S. federal and information about the disease, its
November 2020. Clin Infect Dis. 2021 Jul state prisons. Am J Prev Med. 60(6): 840– potential duration, and ways to mitigate
23: ciab653. doi:10.1093/cid/ciab653. 844. doi:10.1016/j.amepre.2021.01.018. it were undeveloped, OSHA decided to
Epub ahead of print. (Suhs et al., July 23, Epub 2021 Feb 22. (Ward et al., June, monitor the situation. As noted below,
2021) 2021) OSHA subsequently issued numerous
Taylor et al. (2021, October 22). Severity of Washington State Department of Health
Disease Among Adults Hospitalized with
guidance documents advising interested
(WSDH). (2021, September 8). Statewide employers of steps they could take to
Laboratory-Confirmed COVID–19 Before COVID–19 outbreak report. (WSDH,
and During the Period of SARS–CoV–2 September 8, 2021)
mitigate the hazard arising from the
B.1.617.2 (Delta) Predominance— Weed M and Foad A. (2020, September 10). virus.
COVID–NET, 14 States, January–August Rapid Scoping Review of Evidence of Also beginning in early 2020, OSHA
2021. MMWR Early Release/October 22, Outdoor Transmission of COVID–19. received numerous petitions and
2021/70. https://www.cdc.gov/mmwr/ medRxiv preprint. doi:10.1101/ supporting letters from members of
volumes/70/wr/mm7043e1.htm. (Taylor 2020.09.04.20188417. (Weed and Foad, Congress, unions, advocacy groups, and
et al., October 22, 2021). September 10, 2020) one group of large employers urging the
Tennessee Department of Health (TDH). Wei J et al. (2021, July 5). Anti-spike agency to take immediate action by
(2021, September 8). COVID–19 critical antibody response to natural SARS–
indicators. https://www.tn.gov/content/ issuing an ETS to protect employees
CoV–2 infection in the general
dam/tn/health/documents/cedep/novel- population. medRxiv preprint.
from exposure to the virus that causes
coronavirus/CriticalIndicatorReport.pdf. doi:10.1101/2021.07.02.21259897. (Wei COVID–19 (Scott and Adams, January
(TDH, September 8, 2021) et al., July 5, 2021) 30, 2020; NNU, March 4, 2020; AFL–
Twohig K et al. (2021, August 27). Hospital Williams SV et al. (2021, July 8). An outbreak CIO, March 6, 2020; Menendez et al.,
admission and emergency care caused by the SARS–CoV–2 Delta March 9, 2020; Wellington, March 12,
attendance risk for SARS–CoV–2 delta (B.1.617.2) variant in a care home after 2020; DeVito, March 12, 2020; Carome,
(B.1.617.2) compared with alpha partial vaccination with a single dose of March 13, 2020; SMART, March 30,
(B.1.1.7) variants of concern: A cohort the COVID–19 vaccine Vaxzevria, 2020; Blumenthal et al., April 8, 2020;
study. The Lancet Infectious Disease. London, England, April 2021. Euro
https://doi.org/10.1016/S1473- Surveill. 26(27): 2100626. doi:10.2807/
Murray et al., April 29, 2020; Luong,
3099(21)00475–8. (Twohig et al., August 1560–7917.ES.2021.26.27.2100626. April 30, 2020; Novoa, June 24, 2020;
27, 2021) (Williams et al., July 8, 2021) Solt, April 28, 2020; Castro et al., April
University of California San Diego (UCSD). Wingate K. (2021, September 24). Five dead 29, 2020; Talbott and Adely, May 4,
(2021). Better Primary Care for You and and 74 infected after COVID–19 outbreak 2020; Public Citizen, March 13, 2020;
App. 29
61430 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
LULAC, March 31, 2020; Meuser, May In addition to the various petitions for b. OSHA’s Decision To Promulgate a
1, 2020; Raskin, April 29, 2020; rulemaking that were submitted to Healthcare ETS
Cartwright et al., May 7, 2020; Frosh et OSHA, the AFL–CIO filed a petition for OSHA subsequently issued the
al., May 12, 2020; Pellerin, March 19, a writ of mandamus with the U.S. Court Healthcare ETS to protect healthcare
2020; Yborra, March 19, 2020; Owen, of Appeals for the D.C. Circuit, workers. 86 FR 32376. (June 21, 2021),
March 19, 2020; Brown et al., April 30, requesting that the court compel OSHA codified at 29 CFR 1910.502. Looking
2020; Price et al., May 1, 2020; to issue an ETS. (AFL–CIO, May 18, back on a year of experience, OSHA
ORCHSE, October 9, 2020). These 2020). In its administrative decision and found that its enforcement efforts had
petitions and supporting letters argued filing in that case, OSHA explained that encountered significant obstacles,
that many employees had been infected the determination not to issue an ETS demonstrating that existing standards,
because of workplace exposures to the was based on the conditions and regulations, and the General Duty
virus that causes COVID–19, and that information available to the agency at Clause were inadequate to address the
immediate, legally enforceable action is that time and was subject to change as grave danger faced by healthcare
necessary for protection. OSHA quickly additional information indicated the employees. 86 FR 32415. In
began issuing detailed guidance need for an ETS. On June 11, 2020, the promulgating that ETS, OSHA
documents and alerts beginning in U.S. Court of Appeals for the D.C. recognized that ‘‘the impact of [COVID–
March 2020 that helped employers to Circuit issued a one paragraph per 19] has been borne disproportionately
determine employee risk levels of curiam order denying the AFL–CIO’s by the healthcare and healthcare
COVID–19 exposure and made petition to require OSHA to issue an support workers tasked with caring for
recommendations for appropriate ETS. To be clear, nothing in OSHA’s those infected by this disease.’’ 86 FR
controls. As explained in detail in prior position or the D.C. Circuit’s 32377. Furthermore, states and localities
Section IV. of the Healthcare ETS, 86 FR decision in In re Am. Fed’n of Labor & had taken increasingly divergent
32376, 32412–13 (June 21, 2021) and Cong. of Indus. Orgs., No. 20–1158, approaches to workplace protections
hereby included in the record for this 2020 WL 3125324 (D.C. Cir. June 11, against COVID–19, making it clear that
ETS,16 at the time, OSHA leadership 2020); rehearing en banc denied (July a federal standard was needed to ensure
believed that implementing a 28, 2020) precludes OSHA’s decision to sufficient protection in all states. 86 FR
combination of enforcement tools, promulgate an ETS now. To the 32377. Therefore, OSHA focused on the
including guidance, existing OSHA contrary, at an early phase of the unique situation experienced by
standards, and the General Duty Clause, pandemic, when vaccines were not yet healthcare industry workers as the
would provide the necessary protection available and when it was not yet frontline caregivers and support workers
for workers. OSHA also expressed known how extensive the impact would for those suffering from COVID–19. See
concern that an ETS might be on illness and death, the court 86 FR 32376, 32411–12.
unintentionally enshrine requirements decided not to second-guess OSHA’s The Healthcare ETS requires
that are subsequently proven ineffective decision to hold off on regulation in employers to institute a suite of
in reducing transmission. order to see if its nonregulatory engineering controls, administrative
When it decided not to issue an ETS enforcement tools could be used to controls, work practices, and personal
in the spring of 2020, OSHA determined provide adequate protection against the protective equipment to combat the
that the agency could provide sufficient virus. ‘‘OSHA’s decision not to issue an COVID–19 hazard. In the Preamble to
employee protection against COVID–19 ETS is entitled to considerable the Healthcare ETS, OSHA observed
through enforcing existing workplace deference,’’ the court explained, noting that the development of safe and highly
standards and the General Duty Clause ‘‘the unprecedented nature of the effective vaccines is a critical milestone
of the OSH Act, coupled with issuing COVID–19 pandemic’’ and concluding in the nation’s response to COVID–19,
industry-specific, non-mandatory merely that ‘‘OSHA reasonably and that fully vaccinated persons have
guidance. However, in doing so OSHA determined that an ETS is not necessary a greatly reduced risk of death,
indicated that its conclusion that an at this time.’’ (Id., with emphasis hospitalization and other health
ETS was not necessary was specific to added). consequences. 86 FR 32396. The
that time, and that the agency would Healthcare ETS therefore includes
Employers do not have a reliance provisions intended to encourage
continue to monitor the situation and
interest in OSHA’s prior decision not to employees to become vaccinated,
take additional steps as appropriate (see,
issue an ETS on May 29, 2020, which including a requirement for employers
e.g., OSHA, March 18, 2020 Letter to
did not alter the status quo or require to provide reasonable paid leave for
Congressman Scott (stating ‘‘[W]e
employers to change their behavior. See vaccination and recovery from any side
currently see no additional benefit from
Dep’t of Homeland Security v. Regents effects. 86 FR 32415, 29 CFR
an ETS in the current circumstances
of the Univ. of California, 140 S. Ct. 1910.502(m).
relating to COVID–19. OSHA is
continuing to monitor this quickly 1891, 1913–14 (2020). As OSHA In the Healthcare ETS OSHA found
evolving situation and will take the indicated when it made the decision, that employees who work in covered
appropriate steps to protect workers the determination was based on the healthcare workplaces are exposed to
from COVID–19 in coordination with conditions and information available to grave danger. 86 FR 32411. The agency
the overall U.S. government response the agency at that time and was subject also stated that in light of the
effort.’’ (emphasis supplied); DOL May to change as additional information effectiveness of vaccines, there was
29, 2020 at 20 (stating ‘‘OSHA has indicated the need for an ETS. In light ‘‘insufficient evidence in the record to
determined this steep threshold [of of the agency’s express qualifications support a grave danger finding for non-
necessity] is not met here, at least not and the surrounding context, any healthcare workplaces where all
at this time.’’ (emphasis supplied))). employer reliance would have been employees are vaccinated.’’ 86 FR 32396
unjustified and cannot outweigh the (emphasis supplied). OSHA made no
16 This adoption includes the citations in the
countervailing urgent need to protect finding at that time regarding
referenced section of the Healthcare ETS, which are workers covered by this ETS from the unvaccinated workers in non-healthcare
also included in the docket for this ETS. grave danger posed by COVID–19. workplaces.
App. 30
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61431
No employer challenged the moving average reached over 60,000 as 2021). The World Health Organization
Healthcare ETS in court. The United the Delta Variant spread across the has classified the Lambda and Mu
Food and Commercial Workers Union country. (CDC, August 26, 2021). The 7- variants as ‘‘variants of interest,’’
(UFCW) together with the AFL–CIO day moving average of reported cases at meaning that they have genetic changes
filed a petition for review asserting that the beginning of September, 2021 that affect transmissibility, disease
the rule should have gone further and exceeded 161,000 (CDC, October 18, severity, immune escape, diagnostic or
included more industries in its scope 2021—Daily Cases). The most recent 7- therapeutic escape; and have been
(UFCW and AFL–CIO, June 24, 2021). day moving average of reported cases, identified to cause significant
That case is being held in abeyance while lower than the peak in late community transmission or multiple
pending the issuance of this ETS. August and early September, is still over COVID–19 clusters, in multiple
85,000. (CDC, October 18, 2021—Daily countries with increasing relative
c. Subsequent Developments
Cases). These rates are also far higher prevalence alongside increasing number
The preamble to the Healthcare ETS than the rate when OSHA first declined of cases over time, or other apparent
notes that new COVID–19 variants to issue an ETS. (CDC, August 27, 2020 epidemiological impacts to suggest an
might emerge that are more (20,401 confirmed cases per day on May emerging risk to global public health
transmissible and cause more severe 29, 2020)). The jump in infections has (WHO, October 12, 2021). Medical
illness, but does not specifically resulted in increased hospitalizations experts have also explained that
mention the Delta Variant. See 86 FR and deaths for unvaccinated workers, as vaccination reduces the opportunities
32384. Since publication of the discussed in detail in Grave Danger for the virus to continue to mutate by
Healthcare ETS, the Delta Variant has (Section III.A. of this preamble). While reducing transmission and length of
become the dominant form of the virus the most current data reflect a decline infection. And, there is no indication
in the United States, causing large in new cases from the peak, the level of that future variants of COVID–19 will
spikes in transmission, and surges of new cases remains high. CDC data not be equally or even more dangerous
hospitalizations, and deaths, shows that, as of October 18, 2021, than Delta without a higher rate of
overwhelmingly among the approximately 85% of U.S. counties vaccination (Bollinger and Ray, July 23,
unvaccinated (CDC, August 26, 2021; were experiencing ‘‘high’’ rates of 2021).
CDC, October 18, 2021—Variant community transmission, and another Meanwhile, evidence on the power of
Proportions, July Through October, 10% were experiencing ‘‘substantial’’ vaccines to safely protect individuals
2021). As discussed in more detail in community transmission (CDC, October from infection and especially from
Grave Danger (Section III.A. of this serious disease has continued to
18, 2021—Daily Cases). Although the
preamble), the Delta Variant is at least accumulate. (CDC, May 21, 2021). For
number of new detected cases is
twice as contagious as previous COVID– example, as explained in more detail in
currently declining nationwide (see
19 variants, and research suggests that it Grave Danger (Section III.A. of this
CDC, October 18, 2021—Community
also causes more severe illness in the preamble), multiple studies have
Transmission Rates), the agency cannot
unvaccinated population (CDC, August demonstrated that vaccines are highly
assume based on past experience that
26, 2021). More infections mean more effective at reducing instances of
nationwide case levels will not increase
potential for exposures, including in hospitalization and death. In September
again. Indeed, many northern states are
workplaces (see Grave Danger, Section the CDC compiled data from various
currently experiencing increases in their
III.A. of this preamble, for further studies that demonstrated overall
discussion on workplace outbreaks, rate of new cases (see CDC, October 18,
authorized vaccines reduced death and
clusters, and the general impact of 2021—Cases, Deaths, and Laboratory
severe case rates by 91 and 92%
transmission in the workplace.). More Testing (NAATS) by State; Slotnik,
respectively in the population studied
infections also mean more opportunities October 18, 2021), including Vermont,
between April and July (Scobie et al.,
for the virus to undergo mutations to its which set a new record for new COVID–
September 17, 2021, Table 1.).
genetic code, resulting in genetic 19 cases in mid-October 2021 (Murray,
Additionally, the FDA granted approval
variants with the potential to infect or October 18, 2021). Unless vaccination
to the Pfizer-BioNTech COVID–19
re-infect people. rates increase, the experience of
Vaccine for individuals 16 years of age
Some variability in infection rates in northern states during this fall could
and older on August 23, 2021 (FDA,
a pandemic is to be expected. While the presage a greater resurgence in cases August 23, 2021). In announcing the
curves of new infections and deaths can this winter as colder weather drives decision, the FDA Commissioner
bend down after peaks, they often more individuals indoors (see Firozi explained that ‘‘[w]hile this and other
reverse course only to reach additional and Dupree, October 18, 2021). vaccines have met the FDA’s rigorous,
peaks in the future (Moore et al., April While it is important to recognize that scientific standards for emergency use
30, 2020). Last year experts expressed the Delta Variant has caused a spike in authorization, as the first FDA-approved
concern that one or more subsequent hospitalization and death in the United COVID–19 vaccine, the public can be
waves of COVID–19 were possible in States, the SARS–CoV–2 virus, and not very confident that this vaccine meets
2021 (Moore et al., April 30, 2020), just a particular variant of that virus, is the high standards for safety,
especially with new variants of COVID– the hazard that workers face (see Grave effectiveness, and manufacturing quality
19 in circulation (Doughton, February 9, Danger, Section III.A. of this preamble). the FDA requires of an approved
2021). That potential tragically became Like any virus, SARS–CoV–2 has the product.’’ (FDA, August 23, 2021.)
a reality with the spread of the Delta ability to mutate over time and produce Despite this important milestone, and
Variant. variants that may be more or less severe. the demonstrated effectiveness of the
In June 2021, when the Healthcare Indeed, the World Health Organization approved and authorized vaccines
ETS was published, COVID–19 and the CDC both track new variants available to the public, millions of
transmission rates in the United States that have continued to arise, such as the employees remain unvaccinated,
were at a low point, with the 7-day Lamda and Mu Variants (WHO, October approximately 39% of workers who are
moving average of reported cases to be 12, 2021; CDC, October 4, 2021). At this covered by this ETS (See Economic
about 12,000. (CDC, August 26, 2021) time, the CDC is tracking 11 different Analysis, Section IV.B. of this ETS). The
However, by the end of July, the 7-day variants of COVID–19 (CDC, October 4, rate of vaccination in the United States
App. 31
61432 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
has slowed significantly from its peak in for Infectious Disease.’’ (AFL–CIO, Cisneros Jr. GR, Napolitano GF,
April, when the daily number of March 6, 2020) Velazquez NM, Garcia SR, Grijalva R.
vaccination doses administered American Federation of Labor and Congress (2020, April 29). ‘‘COVID–19 ETS
of Industrial Organizations (AFL–CIO). Petition.’’ (Castro et al., April 29, 2020)
exceeded three million at one point. In
(2020, May 18). ‘‘Emergency Petition For Centers for Disease Control and Prevention
recent months, daily vaccination rates A Writ Of Mandamus, and Request For (CDC). (2020, August 27). Previous U.S.
have hovered around one million doses Expedited Briefing And Disposition, No. Covid-19 Case Data. https://
administered, or lower (CDC, October 19–1158.’’ (AFL–CIO, May 18, 2020) www.cdc.gov/coronavirus/2019-ncov/
18, 2021—Daily Vaccination Rate). The An Act Prohibiting Discrimination Based on covid-data/previouscases.html. (CDC,
shortfall in vaccination leaves the a Person’s Vaccination Status or August 27, 2020)
nation’s working population vulnerable Possession of an Immunity Passport; Centers for Disease Control and Prevention
to sickness, hospitalization and death, Montana H.B. 702. (2021, July 1). https:// (CDC). (2021, May 21). Interim Estimates
leg.mt.gov/bills/2021/billpdf/ of Vaccine Effectivness of Pfizer-
whether today under the Delta Variant,
HB0702.pdf. (Montana H.B. 702 July 1, BioNTech and Moderna COVID–19
or under future variants that may arise 2021) Vaccines Among Health Care
(CDC, October 18, 2021—Daily Arizona Executive Order 2021–18. (2021, Personnel—33 U.S. Sites, January–March
Vaccination Rate); see also Grave Danger August 16). https://azgovernor.gov/sites/ 2021. https://www.cdc.gov/mmwr/
(Section III.A. of this preamble). default/files/eo_2021-18.pdf. (AZ volumes/70/wr/mm7020e2.htm. (CDC,
Moreover, in recent months, an Executive Order 2021–18, August 16, May 21, 2021)
increasing number of states have 2021) Centers for Disease Control and Prevention
promulgated Executive Orders or Arkansas H.B. 1977. (2021, October 1). To (CDC). (2021, August 26). Delta Variant:
statutes that prohibit workplace Provide Employee Exemptions From What We Know About the Science.
Federal Mandates and Employer https://www.cdc.gov/coronavirus/2019-
vaccination policies that require
Mandates Related to Coronavirus 2019 ncov/variants/delta-variant.html?s_
vaccination or proof of vaccination (COVID–19); and to Declare an cid=11512:cdc%20delta
status, thus attempting to prevent Emergency. https:// %20variant:sem.ga:p:RG:GM:
employers from implementing the most www.arkleg.state.ar.us/Bills/ gen:PTN:FY21. (CDC, August 26, 2021)
efficient and effective method for FTPDocument?path=%2 Centers for Disease Control and Prevention
protecting workers from the hazard of FAMEND%2F2021R%2FPublic (CDC). (2021, October 4). SARS–CoV–2
COVID–19 (see, e.g., Texas Executive %2FHB1977–H1.pdf. (Arkansas H.B. Variant Classifications and Definitions.
Order GA–40, October 11, 2021; 1977, October 1, 2021) https://www.cdc.gov/coronavirus/2019-
Montana H.B. 702, July 1, 2021; Arkansas S.B. 739. (2021, October 4). An Act ncov/variants/variant-info.html. (CDC,
Concerning Employment Issues Related October 4, 2021)
Arkansas S.B. 739, October 4, 2021 and
to Coronavirus 2019 (COVID–19); To Centers for Disease Control and Prevention
Arkansas H.B. 1977, October 1, 2021; Provide Employee Exemptions From (CDC). (2021, October 18). COVID Data
AZ Executive Order 2021–18, August Federal Mandates and Employer Tracker. https://covid.cdc.gov/covid-
16, 2021). While some States’ bans have Mandates Related to Coronavirus 2019 data-tracker/. (CDC, October 18, 2021)
focused on preventing local (COVID–19); To Declare and Emergency; DeVito J. (2020, March 12). ‘‘Grant OSHA
governments from requiring their public and For Other Purposes. https:// emergency standard for COVID–19 to
employees to be vaccinated or show www.arkleg.state.ar.us/Bills/ protect frontline workers.’’ (DeVito,
proof of vaccination, the Texas, FTPDocument?path=%2 March 12, 2020)
Montana, and Arkansas requirements FBills%2F2021R%2 Doughton S. (2021, February 9). Can a fourth
FPublic%2FSB739.pdf. (Arkansas S.B. wave of COVID–19 be prevented? Not
apply to private employers as well.
739, October 4, 2021) likely, says Fred Hutch model—but the
Other states have banned local Blumenthal R, Murray P, Duckworth T, Casey curve could be flattened. The Seattle
ordinances that require employers to RP, Baldwin B, Brown S, Menendez R. Times. https://www.seattletimes.com/
ensure that customers who enter their (2020, April 8). ‘‘COVID–19 ETS seattle-news/health/can-a-fourth-wave-
premises wear masks, thus endangering Petition.’’ (Blumenthal et al., April 8, of-covid-19-be-prevented-not-likely-says-
the employees who work there, 2020) fred-hutch-model-but-the-curve-could-
particularly those who are unvaccinated Bollinger R and Ray R. (2021, July 23). New be-flattened/. (Doughton, February 9,
(see, e.g., Florida Executive Order 21– Variants of the Coronavirus: What You 2021)
102, May 3, 2021; Texas Executive Should Know. Johns Hopkins Medicine. Firozee P and Dupree J. (2021, October 18).
https://www.hopkinsmedicine.org/ Coronavirus numbers are dropping. More
Order GA–34, March 2, 2021).
health/conditions-and-diseases/ vaccinations can prevent a winter surge,
In short, at the present time, workers
coronavirus/a-new-strain-of-coronavirus- Fauci says. The Washington Post.
are becoming sick and dying what-you-should-know. (Bollinger and https://www.washingtonpost.com/
unnecessarily as a result of occupational Ray, July 23, 2021) health/2021/10/18/faucis-americans-
exposures, when there is a simple and Brown S, Murray P, Baldwin T, Bennet MF, can-prevent-winter-pandemic-surge/.
effective measure, vaccination, that can Casey Jr. RP, Whitehouse S, Hirono MK, (Firozee and Dupree, October 18, 2021)
largely prevent those deaths and Blumenthal R, Van Hollen C, Masto CC, Florida Executive Order 21–102. (2021, May
illnesses (see Grave Danger, Section Sanders B, Reed J, Harris KD, Wyden R, 3). https://www.flgov.com/wp-content/
III.A. of this preamble). Congress Durbin RJ, Booker CA, Warren E, Leahy uploads/orders/2021/EO_21-102.pdf.
charged OSHA with responsibility for PJ. (2020, April 30). ‘‘COVID–19 ETS (Florida Executive Order 21–102, May 3,
Petition.’’ (Brown et al., April 30, 2020) 2021)
issuing emergency standards when they
Carome M. (2020, March 13). ‘‘Letter Food and Drug Administration (FDA) (2021,
are necessary to protect employees from requesting an immediate OSHA August 23). FDA Approves First COVID–
grave danger. 29 U.S.C. 655(c). In light emergency temporary standard for 19 Vaccine. https://www.fda.gov/news-
of the current situation, OSHA is issuing infectious disease.’’ (Carome, March 13, events/press-announcements/fda-
this emergency rule. 2020) approves-first-covid-19-vaccine. (FDA,
Cartwright M, Kaptur M, Roybal-Allard L, August 23, 2021)
References Foster B. (2020, May 7). ‘‘COVID–19 ETS Frosh BE, Becerra X, Weiser PJ, Jennings K,
American Federation of Labor and Congress Petition.’’ (Cartwright et al., May 7, 2020) Racine KA, Raoul K., Frey AM, Healey
of Industrial Organizations (AFL–CIO). Castro J, Espaillat A, Cárdenas T, Ocasio- M., Nessel D, Ellison K, Ford AD, Grewal
(2020, March 6). ‘‘To Address the Cortez A, Sablan GKC, Garcia J, Gallego GS, Balderas H, James L, Rosenblum EF,
Outbreak of COVID–19: A Petition for an R, Escobar V, Vargas J, Trahan L, Torres Shapiro J, Neronha P, Herring MP,
OSHA Emergency Temporary Standard NJ, Correa L, Barragán ND, Serrano JE, Ferguson B, Kaul JL. (2020, May 12).
App. 32
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61433
‘‘COVID–19 ETS Petition.’’ (Frosh et al., Price D, Pocan M, Schakowsky J, DeLauro workers from COVID–19.’’ (Yborra,
May 12, 2020) RL. (2020, May 1). ‘‘COVID–19 ETS March 19, 2020)
League of United Latin American Citizens Petition.’’ (Price et al., May 1, 2020)
(LULAC). (2020, March 31). ‘‘COVID–19 Public Citizen. (2020, March 13). ‘‘Support II. This ETS Is Necessary To Protect
ETS Petition.’’ (LULAC, March 31, 2020) for AFL–CIO’s Petition for an OSHA Unvaccinated Employees From Grave
Luong M. (2020, April 30). ‘‘Petition for an Emergency Temporary Standard for Danger
OSHA Emergency Temporary Standard Infectious Disease to Address the As explained at length in the
for Airborne Infectious Diseases.’’ Epidemic of Novel Coronavirus Disease.’’
(Luong, April 30, 2020) (Public Citizen, March 13, 2020)
preceding section (Grave Danger,
Menendez R, Murray P, Baldwin T, Brown S, Raskin J. (2020, April 29). ‘‘COVID–19 ETS Section III.A. of this preamble), OSHA
Duckworth T, Booker CA, Warren E. Petition.’’ (Raskin, April 29, 2020) has determined that most unvaccinated
(2020). ‘‘Urge DOL to Direct OSHA to Scobie HM et al. (2021, September 17). workers across the U.S. economy are
Issue Comprehensive Emergency Monitoring Incidence of COVID–19 facing a grave danger posed by the
Temporary Standard (ETS) To Protect Cases, Hospitalizations, and Deaths, by COVID–19 hazard.17 This new hazard
Workers Against COVID–19.’’ (Menendez Vaccination Status—13 U.S. has taken the lives of more than 725,000
et al., March 9, 2020) Jurisdictions, April 4–July 17, 2021. people—many of them workers—in the
Meuser D. (2020, May 1). ‘‘COVID–19 ETS MMWR Morb Mortal Wkly Rep 2021; 70:
Petition.’’ (Meuser, May 1, 2020) United States since it was first detected
early release. https://www.cdc.gov/
Moore KA et al. (2020, April 30). COVID–19: mmwr/volumes/70/wr/mm7037e1.htm. in this country in early 2020. As the
The CIDRAP Viewpoint. Part 1: The (Scobie et al., September 17, 2021) federal agency tasked with protecting
Future of the COVID–19 Pandemic: Scott RC and Adams AS. (2020, January 30). the safety and health of workers in the
Lessons Learned from Pandemic ‘‘Prioritize OSHA’s Work on Infectious United States, OSHA is required to act
Influenza. University of Minnesota Diseases Standard/Immediate Issue of when it finds that workers are exposed
Center for Infectious Disease Research Temporary Standard.’’ (Scott and to a grave danger. 29 U.S.C. 655(c)(1).
and Policy. https:// Adams, January 30, 2020)
www.cidrap.umn.edu/sites/default/files/ OSHA now finds that this emergency
Slotnik D. (2021, October 18). Coronavirus temporary standard is necessary to
public/downloads/cidrap-covid19- cases rise in the northern U.S. amid
viewpoint-part1_0.pdf. (Moore et al., lower temperatures. The New York
protect employees who are
April 30, 2020) Times. https://www.nytimes.com/live/ unvaccinated. Asbestos Info. Ass’n, 727
Murray E. (2021, October 18). Vermont sets 2021/10/18/world/covid-delta-variant- F.2d at 423 (‘‘failure to act does not
new positive COVID daily case record as vaccine#covid-cases-us-winter. (Slotnik, conclusively establish that a situation is
delta surge continues. Burlington Free October 18, 2021) not an emergency . . . [when there is a
Press. https://
www.burlingtonfreepress.com/story/
International Association of Sheet Metal, Air, grave danger to workers,] to hold that
Rail and Transportation Workers because OSHA did not act previously it
news/local/2021/10/18/covid-vermont-
(SMART). (2020, March 30). ‘‘Petition for cannot do so now only compounds the
new-daily-positive-case-record-set/
Emergency Standards.’’ (SMART, March consequences of the Agency’s failure to
8505021002/. (Murray, October 18, 2021)
30, 2020)
Murray P, Brown S, Heinrich M, Brown S,
Solt BE. (2020, April 28). ‘‘COVID–19 ETS
act.’’). As explained in detail below,
Blumenthal R., Markey EJ, Van Hollen C, OSHA has determined that vaccination
Durbin RJ, Smith T, Whitehouse S, Petition’’ (Solt, April 28, 2020)
Talbott R and Adely R. (2020, May 4). is the most effective control for abating
Wyden R, King Jr. AS, Kaine T, Reed J, the grave danger that unvaccinated
Menedez R, Gillibrand K, Duckworth T, ‘‘Rulemaking Petition to the United
Warren E, Hassan MW, Casey Jr. RP, States Department of Labor Occupational employees face from the COVID–19
Sanders B, Udall T, Hirono MK, Harris Safety and Health Administration.’’ hazard. And, for workers who are not
KD, Feinstein D, Klobuchar A, Booker (Talbott and Adely, May 4, 2020) vaccinated, the use of testing, face
CA, Shaheen J, Cardin B. (2020, April Texas Executive Order GA–34. (2021, March coverings, and removal from the
29). ‘‘COVID–19 ETS Petition.’’ (Murray 2). https://open.texas.gov/uploads/files/ workplace, while not as effective as
et al., April 29, 2020) organization/opentexas/EO-GA-34-
opening-Texas-response-to-COVID-
vaccination, is still effective and
National Nurses United (NNU). (2020, March necessary.
4). ‘‘National Nurses United Petitions disaster-IMAGE-03-02-2021.pdf. (Texas
Executive Order GA–34, March 2, 2021) OSHA has determined that the best
OSHA for an Emergency Temporary method for addressing the grave danger
Standard on Emerging Infectious Texas Executive Order GA–40. (2021,
Diseases in Response to COVID–19.’’ October 11). https://gov.texas.gov/ that COVID–19 poses to unvaccinated
(NNU, March 4, 2020) uploads/files/press/EO-GA-40_ workers is to strongly encourage the use
Novoa M. (2020, June 24). ‘‘Direct OSHA to prohibiting_vaccine_mandates_ of the single most effective and efficient
issue an emergency temporary standard legislative_action_IMAGE_10-11- protection available: Vaccination. OSHA
to protect all workers from COVID–19 2021.pdf. (Texas Executive Order GA–
now!’’ (Novoa, June 24, 2020) 40, October 11, 2021) 17 As explained in the Grave Danger section, this
Occupational Safety and Health United Food and Commercial Workers ETS focuses on protecting unvaccinated workers
Administration (OSHA). Letter from International Union (UFCW) and from the grave danger that COVID–19 poses in the
Loren Sweatt to Congressman Robert C. American Federation of Labor and workplace. OSHA did not include fully vaccinated
‘‘Bobby’’ Scott. (OSHA, March 18, 2020) Congress of Industrial Organizations workers in its finding of grave danger because such
ORCHSE Strategies. (2020, October 9). (AFL–CIO). (2021, June 24). ‘‘Petition for workers are generally much better protected from
Review, filed with the D.C. Circuit on the effects of COVID–19, and, in particular, the
‘‘Petition to the U.S. Department of most severe effects, than workers who are
Labor—Occupational Safety and Health June 24, 2021.’’ (UFCW and AFL–CIO,
unvaccinated. OSHA’s action in adopting this ETS
Administration (OSHA) for an June 24, 2021) for unvaccinated workers does not mean that
Emergency Temporary Standard (ETS) Wellington M. (2020, March 12). ‘‘Grant vaccinated workers do not face a significant risk
for Infectious Disease.’’ (ORCHSE, OSHA emergency standard for COVID– from COVID–19, or that the OSH Act’s general duty
October 9, 2020) 19 to protect front-line workers’’ clause poses no obligation on employers to protect
Owen M. (2020, March 19). ‘‘Grant OSHA (Wellington, March 12, 2020) their vaccinated workers from COVID–19. Indeed,
emergency standard to protect frontline World Health Organization (WHO). (2021, symptomatic infections can occur in fully
workers from COVID–19.’’ (Owen, March October 12). Tracking SARS–CoV–2 vaccinated people, and COVID–19 therefore poses
at least some risk to vaccinated workers. OSHA has
19, 2020) variants. https://www.who.int/en/
requested comment on the risks faced by vaccinated
Pellerin C. (2020, March 19). ‘‘Grant OSHA activities/tracking-SARS-CoV-2-variants/ workers from COVID–19, and what additional
emergency standard to protect frontline . (WHO, October 12, 2021) measures, if any, should be taken to protect both
workers from COVID–19.’’ (Pellerin, Yborra G. (2020, March 19). ‘‘Grant OSHA vaccinated and unvaccinated workers (see Request
March 19, 2020) emergency standard to protect frontline for Comments, Section I.B. of this preamble).
App. 33
61434 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
has long recognized the importance of administrative, engineering, and other lasting benefits; namely, a drastic
vaccinating workers against preventable controls to reduce workplace exposure reduction in the risk of severe health
illnesses to which they may be exposed to the virus. And, for certain work effects or death. The vaccine works by
on the job. See 56 FR 64004, 64152 (Dec. settings in the healthcare industry bolstering the worker’s immune system
6, 1991) (discussing requirement in where people with COVID–19 are and does not depend on the worker’s
Bloodborne Pathogens standard for reasonably expected to be present, acumen or actions to afford its
employer to make hepatitis B vaccine OSHA both encouraged vaccination and protection. Moreover, where an
available to any employees with mandated a suite of protections, many employer implements one or more non-
occupational exposure to blood and of which involve physical controls (see pharmaceutical controls at the
other potentially infectious materials). 29 CFR 1910.502). Indeed, workers who workplace, vaccination provides
As explained in Grave Danger (Section work indoors and near others are best workers with a backstop of protection
III.A. of this preamble), COVID–19 protected from COVID–19 when they that greatly reduces their risk of serious
vaccines do not completely eliminate are fully vaccinated and their exposure health effects if they are exposed to the
the potential for infection, but to COVID–19 is reduced (to the extent virus despite the presence of other
significantly reduce the likelihood of possible) by non-pharmaceutical controls. Vaccination thus ensures that
infection, and in turn, transmission of controls. workers need not rely on other factors,
the virus to others. Data from clinical Non-pharmaceutical controls, be it the workplace environment, the
trials for all three vaccines and however, focus on preventing employee effectiveness of equipment, or the
observational studies for the two mRNA exposure to the virus, and do not actions of other individuals, to be
vaccines clearly establish that fully directly affect an employee’s immune substantially protected from the worst
vaccinated persons have a greatly response if exposure to the virus does potential outcomes of a COVID–19
reduced risk of SARS–CoV–2 infection occur. Additionally, non- infection.
compared to unvaccinated individuals pharmaceutical controls often rely on This ETS focuses on encouraging
(see FDA, December 11, 2020; FDA, the actions of individuals and/or the vaccination because it is the most
December 18, 2020; FDA, February 26, integrity of equipment to be effective; efficient and effective method for
2021). for example, to use PPE to control addressing the grave danger.
More importantly, vaccination is the exposure, a worker must correctly don Vaccination is patently appropriate and
single most effective method for appropriate PPE each time there is feasible for almost every worker in all
protecting workers from the most potential exposure, must properly clean, industries, and will drastically reduce
serious consequences of a COVID–19 store, and maintain the PPE between the risk that unvaccinated workers will
infection: Hospitalization and death. uses, and must replace the PPE when it suffer the serious health outcomes
Although symptomatic infections can is no longer effective (see, e.g., 29 CFR associated with SARS–CoV–2 infection.
occur in fully vaccinated people, they 1910.132 (general PPE requirements in As described in Section III.A. of this
are less likely to occur, and are far less general industry workplaces)). preamble (Grave Danger), employees
likely to result in severe health Accordingly, OSHA standards have who are unvaccinated are in grave
outcomes or death. As discussed in always followed the principle of the danger from the SARS–CoV–2 virus, but
Grave Danger (Section III.A. of this hierarchy of controls, under which employees who are fully vaccinated are
preamble), studies have established that employers must control hazards by not. Since it is the lack of vaccination
the available COVID–19 vaccines are means other than PPE whenever that results in grave danger, vaccination
highly effective at preventing feasible, and PPE is a supplementary will best allay the grave danger. This
hospitalization, and even more effective control. See e.g., 29 CFR 1910.134(a); 29 ETS, which is designed to strongly
at preventing death. For example, one CFR 1910.1030(d)(2). encourage vaccination, is thus
study found that unvaccinated adults Physical distancing requires workers ‘‘necessary to protect employees’’ from
age 18 to 49 were 15.2 times more likely to maintain constant awareness of their a grave danger. 29 U.S.C. 655(c).
to be hospitalized and 17.2 times more environment in order to avoid coming OSHA continues to encourage
likely to die of COVID–19 than fully into close proximity with colleagues, employers to implement additional
vaccinated people in the same age customers, or other individuals, even controls that may be appropriate to
range, and unvaccinated adults age 50 to though the realities of their jobs and/or eliminate exposure to the SARS–CoV–2
64 were 10.9 times more likely to be the design of the workplace may be virus at their workplace, but, as
hospitalized and 17.9 times more likely unaccommodating to that effort. discussed further below, OSHA has not
to die than their fully vaccinated peers Requiring employees to examine required employers to implement a
(Scobie et al., September 17, 2021). The themselves for signs and symptoms comprehensive and multilayered set of
New York Times reported on October 1, consistent with SARS–CoV–2 infection COVID–19 exposure controls in this
2021, that of the approximately 100,000 before reporting to work is prone to ETS. This decision reflects the
individuals who died of COVID–19 human error and entirely ineffective extraordinary and exigent circumstances
since mid-June 2021, less than 3% had when the employee is infected but have required OSHA to immediately
been identified by the CDC as asymptomatic or pre-symptomatic. promulgate this emergency temporary
vaccinated individuals (Boseman and In contrast, a worker is considered standard. Although OSHA was able to
Leatherby, October 1, 2021). fully vaccinated after completing design a comprehensive infection
Vaccines are also uniquely effective primary vaccination with a COVID–19 prevention program for the specific
when compared to non-pharmaceutical vaccine, or the second dose of any healthcare settings to which the June
methods for controlling exposure to combination of two doses of a COVID– 2021 Healthcare ETS applied, this rule
COVID–19 at the workplace. To be sure, 19 vaccine that is approved, authorized, encompasses all industries covered by
non-pharmaceutical controls play an or listed as a two-dose primary the OSH Act, and targets unvaccinated
important role in employers’ efforts to vaccination by the FDA or WHO (see the workers in any indoor work setting not
prevent exposure to the virus; as Summary and Explanation for covered by the Healthcare ETS where
discussed in detail earlier, OSHA has, paragraph (c), Section VI.C. of this more than one person is present.
throughout the pandemic, advised preamble). Once fully vaccinated, a Crafting a multi-layered standard that is
employers to implement various worker enjoys automatic and long- comprehensive and feasible for all
App. 34
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61435
covered work settings, including mixed thousands of workers from becoming workers to be infected by the virus, they
settings of vaccinated and unvaccinated severely ill. are less likely to spread the virus to
workers, is an extraordinarily others at their workplace, including to
a. OSHA Finds It Necessary To Strongly
challenging and complicated unvaccinated coworkers. Increasing
Encourage Vaccination
undertaking, yet the grave danger that workforce vaccination rates will
COVID–19 poses to unvaccinated Despite the proven safety and efficacy therefore reduce the risk that
workers obliges the agency to act as of the available COVID–19 vaccines, unvaccinated workers will be infected
quickly possible. As discussed above, many workers remain unvaccinated and by a coworker.
OSHA has identified vaccination as the are currently exposed to a grave danger. Evidence shows that mandating
single most efficient and effective means As discussed in Grave Danger (Section vaccination has proven to be an
for removing an unvaccinated worker III.A. of this preamble), countless effective method for increasing
from the grave danger. COVID–19 outbreaks have occurred in vaccination rates, and that vaccination
Given the urgency of the rulemaking, myriad work settings where employees mandates have generally been more
and the singular effectiveness of come into contact with others, and in effective than merely encouraging
vaccination in removing unvaccinated recent weeks, the majority of states in vaccination. Significant numbers of
workers from the grave danger, OSHA is the U.S. have experienced what CDC workers would get vaccinated if their
promulgating this ETS to immediately defines as high or substantial employers required it, and many
address the grave danger that COVID–19 community transmission, indicating workers who were vaccinated over the
that there is a clear risk of the virus last four months were motivated by
poses to unvaccinated workers by
being introduced into and circulating in their employer requiring vaccination.
strongly encouraging vaccination. As
workplaces (CDC, October 18, 2021— The Kaiser Family Foundation (KFF)
discussed in Pertinent Legal Authority
Community Transmission Rates). As of vaccine monitor, an ongoing research
(Section II. of this preamble), a ‘‘grave
October 18, 2021, more than 184 million project tracking the public’s attitudes
danger’’ represents a risk greater than
people in the United States have been and experiences with COVID–19
the ‘‘significant risk’’ that OSHA must
fully vaccinated, but only 68.5% of vaccinations, conducted a survey from
show in order to promulgate a
people ages 18 years or older are fully September 13 to September 22, 2021,
permanent standard under section 6(b)
vaccinated (CDC, October 18, 2021— among a nationally representative
of the OSH Act, 29 U.S.C. 655(b). OSHA
Fully Vaccinated). OSHA has estimated random digit dial telephone sample of
will consider whether it is necessary to that approximately 62.4% percent of 1,519 adults ages 18 and older, and
require additional controls to avert a adults aged 18–74 within the scope of found that those who received their first
significant risk of harm in the this ETS are either fully vaccinated or dose of a COVID–19 vaccine after June
rulemaking proceedings that follow this received their first vaccine dose during 1, 2021 were motivated by mandates of
ETS. OSHA directs employers to its the previous two weeks, leaving various sorts, including one in five
website, www.osha.gov/coronavirus, approximately 31.7 million (19%) who say a major reason was that
and the CDC’s website, www.cdc.gov/ unvaccinated (i.e., not fully vaccinated their employer required it (KFF,
coronavirus, for guidance on the and did not receive a first dose with in September 2021). A survey conducted
engineering, administrative, and other the past two weeks) (see Economic by Change Research from August 30 to
exposure controls that may be effective Analysis, Section IV.B. of this preamble, September 2, 2021 regarding Americans’
and appropriate for their workplace. Table IV.B.7). Meanwhile, the rate of views on COVID–19 vaccines found that
OSHA expects that, by strongly new vaccinations has slowed among the 1,775 respondents, ‘‘one of
encouraging vaccination, this ETS will considerably; on October 15, 2021, the the things that was most likely to lead
have a positive impact on worker 7-day moving average number of someone to get vaccinated was if their
health. As discussed above, millions of administered vaccine doses reported to employer required it’’ (Towey,
workers remain unvaccinated and are the CDC per day was 841,731 doses, a September 27, 2021).
presently exposed to risks of steep reduction from the peak 3,448,156 Vaccine mandates imposed by state
hospitalization and death many times dose average that the CDC reported on governments and large employers have
higher than their vaccinated coworkers. April 11, 2021 (CDC, October 18, 2021— also demonstrated the effectiveness of
Although predicting the health impact Weekly Review). mandates in increasing vaccination
of this ETS is particularly challenging, Given the pervasiveness of the virus rates. For example, when Tyson Foods
given the ever-changing nature of the in workplaces across the country and announced its vaccination requirement
pandemic and the many factors that the unparalleled efficacy of vaccines at in early August 2021, only 45% of its
may motivate workers to become fully preventing serious health effects, OSHA workforce had received a vaccination
vaccinated, OSHA has attempted to finds it necessary to strongly encourage dose, but as of September 30, 2021, the
quantify the potential number of vaccination. Encouraging vaccination is New York Times reported that has
hospitalizations and fatalities that this principally necessary to reduce the increased to 91% (White House, October
ETS could avert by increasing workforce likelihood that workers who are infected 7, 2021; Hirsch, September 30, 2021).
vaccination rates (see OSHA, October by the SARS–CoV–2 virus will suffer Similarly, United Airlines reported that
2021c). OSHA has estimated that, as a the worst outcomes of an infection 97% of its U.S.-based employees were
result of the ETS, over 6,500 fewer (hospitalization and death). Put simply, fully vaccinated against COVID–19
currently unvaccinated workers will die the single best method for protecting an within a week of the deadline of the
from COVID–19 over the next six unvaccinated worker from the serious company’s vaccination mandate, and
months. OSHA also estimates that this health consequences of a COVID–19 the 3% who were not fully vaccinated
ETS will prevent over 250,000 currently infection is for that worker to become included several employees who sought
unvaccinated workers from being fully vaccinated. a medical or religious exemption from
hospitalized during that same time Additionally, encouraging vaccination vaccination (The Associated Press,
period. Even if OSHA’s estimate does is necessary to reduce the overall September 22, 2021). In Washington
not prove to be precisely accurate, prevalence of the SARS–CoV–2 virus at State, the weekly vaccination rate
OSHA is confident that this ETS will workplaces. Because vaccinated workers increased 34% after the Governor
save hundreds of lives and prevent are less likely than unvaccinated announced vaccine requirements for
App. 35
61436 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
state workers (White House, October 7, medical procedures to employees in to unvaccinated workers, a more
2021). The success of these COVID–19 numerous subsequent standards, such proactive approach is necessary than
vaccination mandates comports with the as the standards for asbestos (29 CFR simply requiring employers to make
National Safety Council’s recent finding 1910.1001), benzene (1910.1028), cotton vaccination available to employees.
that employers that instituted a COVID– dust (1910.1043), and formaldehyde None of the standards that OSHA
19 vaccination mandate produced a (1910.1048). promulgated prior to this year
35% increase in employee vaccination OSHA adhered to this approach when concerned an infectious agent as readily
(NSC, September 2021). Similarly, the it promulgated the Bloodborne transmissible as COVID–19. Standards
White House recently reported that its Pathogens standard. The agency like the Lead standard do not concern
analysis of vaccination requirements considered mandating a Hepatitis B infectious agents that can be transmitted
imposed by healthcare systems, vaccination, but instead required between individuals at a workplace;
educational institutions, public-sector employers to make the Hepatitis B accordingly, the medical procedures
agencies, and private businesses vaccination available to employees. 56 that employers are required to make
demonstrated that such requirements FR 64004, 64155 (Dec. 6, 1991); 29 CFR available under those standards are
increased their vaccination rates by 1910.1030(f)(1)(i), (f)(2)(i). OSHA solely aimed at protecting the health of
more than 20 percentage points and explained that the agency may have the the worker who is undergoing the
have routinely seen their share of fully legal authority to mandate vaccination, procedure. The Bloodborne Pathogens
vaccinated workers rise above 90 but believed that, under the standard concerned exposure to
percent (White House, October 7, 2021). circumstances, a voluntary vaccination infectious biological agents (Hepatitis B
program would ‘‘foster greater employee and HIV) that can be transmitted
Given the effectiveness of vaccination
cooperation and trust in the system’’ between individuals, but the potential
mandates in increasing vaccination
and ‘‘enhance [ ] compliance while for those agents to be transmitted
rates, OSHA expects that, in most
respecting individuals’ beliefs and between workers is minimal in
instances, an employer implementing a
rights to privacy.’’ 56 FR at 64155. comparison to the SARS–CoV–2 virus;
policy that requires all employees to be In keeping with this traditional
vaccinated will be the most effective Hepatitis B and HIV are transmitted
practice, the agency has stopped short of through blood and certain body fluids,
approach for increasing the vaccination including a strict vaccination mandate
rate of its employees and ensuring that whereas the SARS–CoV–2 virus spreads
with no alternative compliance option through respiratory droplets that can
they have the best protection available in this ETS. OSHA has never done so,
against the worst consequences of a travel through the air from worker-to-
and if it were to take that step, OSHA worker (see Grave Danger, Section III.A.
COVID–19 infection. Although OSHA believes it more prudent to do so where
may well have the authority to impose of this preamble). Vaccination against
the agency has ample time to fully COVID–19 is thus particularly
a vaccination mandate, OSHA has assess the potential ramifications of
decided against pursuing strict important in reducing the potential for
imposing a vaccination mandate on
vaccination requirement and has instead workers to become infected and spread
covered employers and employees.
crafted the ETS to strongly encourage the virus to others at the workplace, in
Here, exigent circumstances demand
vaccination. Employers are in the best addition to protecting the worker from
that OSHA take immediate action to
position to understand their workforces severe health outcomes if they are
protect workers from the grave danger
and the approach that will work most infected. Moreover, the ease with which
posed by COVID–19, but OSHA has not
effectively with them to secure the SARS–CoV–2 virus spreads between
had a full opportunity to study the
employee cooperation and protection. workers makes it more urgent for
potential spectrum of impacts on
OSHA’s traditional practice when workers to be vaccinated, and this
employers and employees, including the
including medical procedures, such as economic and health impacts, that urgency contributes to the agency’s
medical surveillance testing and would occur if OSHA imposed a strict decision to strongly encourage
vaccinations, in its health standards has vaccination mandate with no alternative vaccination.
been to require the employer to make compliance option. Moreover, Accordingly, to further the goal of
the medical procedure available to employers in their unique workplace increasing workforce vaccination rates,
employees, and has viewed mandating settings may be best situated to this ETS requires employers to
those procedures as a measure to avoid understand their workforce and the implement a mandatory vaccination
if possible. For example, when the strategies that will maximize worker policy unless they adopt a policy in
agency promulgated its standard protection while minimizing workplace which employees may either be fully
regulating occupational exposure to disruptions. These considerations vaccinated or regularly tested for
lead, OSHA considered mandating that persuade the agency that this ETS COVID–19 and wear a face covering in
employees participate in physical should afford employers some flexibility most situations when they work near
examinations and biological monitoring, in the form of an alternative option to other individuals. Employers have the
but ultimately required employers to strictly mandating vaccination. In light duty under the OSH Act to provide safe
make them available to employees (see of the unique and grave danger posed by workplaces to their employees,
43 FR 54354, 54450 (Nov. 21, 1978)). COVID–19, OSHA has requested including protecting employees from
OSHA decided against mandating those comment on whether a strict known hazards by complying with
procedures in part because it believed a vaccination mandate is warranted and occupational safety and health
voluntary approach would elicit more the agency will consider all the standards (see 29 U.S.C. 654), and this
effective employee participation in the information it receives as it determines ETS therefore provides employers with
medical program and in part because of how to proceed with this rulemaking two compliance options for protecting
the agency’s concerns about the (see Request for Comment, Section I.B. unvaccinated workers from the grave
Government intruding into a private and of this preamble). danger posed by COVID–19. But while
sensitive area of workers’ lives (43 FR at Although this ETS does not impose a this ETS offers employers a choice in
54450–51). OSHA has followed that strict vaccination mandate, OSHA has how to comply, OSHA has presented
same approach of requiring employers determined that, to adequately address implementation of a vaccination
to ‘‘provide’’ or ‘‘make available’’ the grave danger that COVID–19 poses mandate as the preferred compliance
App. 36
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61437
option; as discussed above, vaccine to elect to be fully vaccinated. As nonemployees at that location are
mandates have proven to be effective in discussed in the Summary and screened prior to employee entry so that
increasing vaccination rates, and OSHA Explanation for paragraph (f) (Section people with suspected or confirmed
expects that, in most instances, VI.F. of this preamble), the ETS requires COVID–19 are not present (1910.502
implementing a vaccination mandate all covered employers to support (a)(2)(v)).
will be the most effective method for vaccination by providing employees Similar to the Healthcare ETS, this
increasing a workforce’s vaccination with reasonable time, including up to ETS requires employers to support
rate. As discussed below, OSHA also four hours of paid time, to receive each vaccination by providing employees
recognizes that requiring that all vaccination dose, and reasonable time with reasonable time, including up to
employees be vaccinated provides more and paid sick leave to recover from four hours of paid time, to receive
protection to vaccinated workers than vaccination side effects. Many workers vaccination, and reasonable time and
regularly testing unvaccinated workers have been deterred from receiving paid sick leave to recover from
for COVID–19 and requiring them to vaccination by fears of missing work vaccination side effects (see discussion
wear face coverings when they work and/or losing pay to obtain vaccination above and the Summary and
near others. This ETS will preempt and/or recover from side effects (see Explanation for paragraph (f), Section
inconsistent state and local Section VI.F. of this preamble; see, e.g., VI.F. of this preamble). However, as
requirements, including requirements KFF, May 6, 2021; KFF, May 17, 2021), discussed above, this ETS goes further
that ban or limit employers’ authority to and OSHA finds that this employer and expressly requires the
require vaccination (see the Summary support is necessary to ensure that implementation of a mandatory
and Explanation for paragraph (a), employees can become fully vaccinated vaccination policy, unless the employer
Section VI.A. of this preamble), and will without concern that they will be implements an alternative policy that
therefore provide the necessary legal sacrificing pay or their jobs to do so. requires unvaccinated workers to be
authorization to covered employers to All covered employers are required by regularly tested for COVID–19 and to
implement mandatory vaccination the ETS to bear the cost of providing up wear face coverings in most situations
policies, if they choose to comply in this to four hours of paid time and when they work near others. While
preferred manner. reasonable paid sick leave needed to nothing in the Healthcare ETS prohibits
Although the ETS does not require all support vaccination, but where an covered employers from implementing a
covered employers to implement a employee chooses to remain mandatory vaccination policy, this ETS
mandatory vaccination policy, OSHA unvaccinated, the ETS does not require presents the implementation of a
expects that employers that choose that employers to pay for the costs mandatory vaccination policy as a
compliance option will enjoy associated with regular COVID–19 preferred compliance option, and will
advantages that employers that opt out testing or the use of face coverings (see preempt inconsistent state and local
of the vaccination mandate option will the Summary and Explanation for requirements that ban or limit
not. Most obviously, employers with a paragraphs (g) and (i), Sections VI.G. employers’ authority to require
mandatory vaccination policy will enjoy and VI.I. of this preamble). In some vaccination. Additionally, where the
a dramatically reduced risk that their cases, employers may be required to pay employer opts out of implementing a
employees will become severely ill or testing and/or face covering costs under mandatory vaccination policy, and the
die of a COVID–19 infection. In other federal or state laws or collective employee opts out of vaccination, this
addition, employers who implement a bargaining obligations, and some may ETS places no obligation on the
vaccination mandate will likely have choose to do so even without such a employer to pay for costs associated
fewer workers temporarily removed mandate, but otherwise employees will with the regular testing of unvaccinated
from the workplace due to a COVID–19 be required to bear the costs if they workers for COVID–19 or their use of
positive test; this rule requires all choose to be regularly tested and wear face coverings, which will provide a
covered employers to remove from the a face covering in lieu of vaccination. financial incentive for some employees
workplace any employee who tests This ETS more strongly encourages to be fully vaccinated.
positive for COVID–19 or receives a vaccination than the June 2021 OSHA finds it necessary to more
diagnosis of COVID–19 (see the Healthcare ETS. OSHA designed the strongly encourage vaccination in this
Summary and Explanation for Healthcare ETS, which addresses the ETS than in the Healthcare ETS in the
paragraph (h), Section VI.H. of this grave danger that COVID–19 poses manner described above. The
preamble), and because vaccinated workers in specific health care settings Healthcare ETS’s provisions that
workers are less likely than where COVID–19-positive individuals encouraged vaccination were packaged
unvaccinated workers to be infected by are reasonably likely to be present, to with a comprehensive infection
the virus, OSHA expects employers encourage vaccination (see 86 FR at prevention program that was tailored to
with a mandatory vaccination policy 32415, 32423, 32565, 32597). the specific healthcare work settings to
will be statistically less likely to be Specifically, the Healthcare ETS which the ETS applied, including a
obliged to remove a COVID-positive encourages vaccination by requiring suite of layered and overlapping
employee from the workplace in employers to provide employees controls. In contrast, OSHA is
accordance with paragraph (h)(2). reasonable and paid time to receive promulgating this ETS to address the
Additionally, only employers who vaccination doses and recover from side grave danger that COVID–19 now poses
decline to implement a mandatory effects (29 CFR 1910.502(m)), and by to all unvaccinated workers who work
vaccination program are required by the exempting from its scope ‘‘well-defined indoors and in the presence of others.
rule to assume the administrative hospital ambulatory care settings where As mentioned above, crafting a
burden necessary to ensure that all employees are fully vaccinated’’ and comprehensive and multi-layered
unvaccinated workers are regularly all non-employees are screened and standard that is comprehensive and
tested for COVID–19 and wear face denied entry if they are suspected or feasible for the myriad work settings to
coverings when they work near others. confirmed to have COVID–19 which this ETS will apply, including
Where employers opt out of (1910.502(a)(2)(iv)) and ‘‘home workplaces as diverse as schools,
implementing a mandatory vaccination healthcare settings where all employees restaurants, retail settings, offices,
program, the ETS encourages employees are fully vaccinated’’ and all prisons, and factories, is an
App. 37
61438 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
extraordinarily challenging and targeted healthcare workers (Goldberg, established that, by identifying and
complicated undertaking. July 9, 2021; Otterman and Goldstein, isolating infected individuals, regularly
Exigent circumstances require OSHA September 28, 2021; Hubler, September testing individuals for COVID–19
to immediately promulgate this ETS to 30, 2021; Beer, October 4, 2021). Even infection can be an effective method for
protect unvaccinated workers, and more healthcare workers covered by 29 reducing virus transmission. Regularly
vaccination is the single most efficient CFR 1910.502 will be subject to a testing unvaccinated workers is
and effective method for removing vaccination mandate under the Centers essential because SARS–CoV–2
unvaccinated workers from the grave for Medicare & Medicaid Services (CMS) infection is often attributable to
danger. Given the urgency of the rule published elsewhere in this issue of asymptomatic or presymptomatic
rulemaking and the singular efficacy of the Federal Register that requires transmission (Bender et al., February 18,
vaccination, OSHA has decided against COVID–19 vaccinations for workers in 2021; Byambasuren et al., December 11,
including comprehensive and most healthcare settings that receive 2020; Johansson et al., January 7, 2021;
multilayered exposure controls in this Medicare or Medicaid reimbursement, Klompas et al., September 2021). In
ETS, and is instead focusing the ETS on including but not limited to hospitals, accordance with the CDC’s
strongly encouraging vaccination. dialysis facilities, ambulatory surgical recommendations, OSHA has set the
Strongly encouraging vaccination is settings, and home health agencies. This minimum frequency of testing at 7 days
thus critical to the effectiveness of this CMS rule applies to at least 76,000 because the agency expects that it will
ETS at protecting unvaccinated workers providers (i.e., employers) and covers a be effective in slowing the spread of
from the grave danger. In Request for majority of healthcare workers across COVID–19, while taking into account
Comment (Section I.B. of this preamble), the country. OSHA expects that the associated cost considerations (see the
OSHA seeks information on what combination of incentives to Summary and Explanation for
additional measures, if any, should be vaccination in the Healthcare ETS and paragraph (g), Section VI.G. of this
required to protect employees against vaccination mandates applicable to preamble). As noted in the Request for
COVID–19. healthcare workers will leave few Comment (Section I.B. of this preamble),
Moreover, stronger encouragement of healthcare workers within the scope of OSHA is gathering additional
vaccination is needed in this ETS than the Healthcare ETS unvaccinated. information about whether OSHA
in the Healthcare ETS because workers should require testing more often than
who are protected by the Healthcare b. Unvaccinated Workers Must Be
on a weekly basis.
ETS are more likely to be vaccinated Regularly Tested for COVID–19 and Use The requirement for unvaccinated
and/or subject to a vaccination mandate. Face Coverings workers to be regularly tested for
The Healthcare ETS, 29 CFR 1910.502, As discussed above, this ETS COVID–19 operates in tandem with
focused on healthcare work settings presumptively requires employers to paragraph (h)(2), which requires that all
where COVID–19 is reasonably expected implement a mandatory vaccination employers remove from the workplace
to be present, and, this ETS does not policy, but permits employers to opt out any employee who receives a positive
apply in settings where any employee of that requirement. Nonetheless, the COVID–19 test, or a COVID–19
provides healthcare services or grave danger that COVID–19 poses to diagnosis (see the Summary and
healthcare support services while they unvaccinated workers demands that Explanation for paragraph (h), Section
are covered by the requirements of 29 alternative protective measures be taken VI.H. of this preamble). Paragraph (h)(2)
CFR 1910.502 (see the Summary and at workplaces where the employer does ensures that the COVID–19-positive
Explanation for paragraph (b), Section not implement a mandatory vaccination employee will be isolated from the
VI.B. of this preamble). Evidence shows policy. Given that the SARS–CoV–2 workplace until it is safe for the
that workers in settings covered by virus is highly contagious, transmitted employee to return, and also allows the
§ 1910.502 already have a high rate of easily through the air, and can lead to employee to seek medical care sooner
vaccination. As of July 2021, healthcare severe and/or fatal outcomes in and reduce the likelihood that they will
workers had a higher rate of vaccination unvaccinated workers, it is critical that suffer the most severe consequences of
than non-healthcare workers (Lazer et employers who do not require their an infection (e.g., by seeking
al., August, 2021), and many healthcare employees to be vaccinated implement monoclonal antibody treatment). The
workers are currently subject to controls to mitigate the potential for combination of the testing and medical
vaccination mandates. Twenty-two COVID–19 outbreaks to occur. As removal provisions will reduce the
states and the District of Columbia have discussed above, and in Grave Danger likelihood that an unvaccinated worker
instituted vaccination mandates that are (Section III.A. of this preamble), who has been infected with COVID–19,
applicable to healthcare workers unvaccinated workers are more likely including those who are not
(NASHP, October 1, 2021), and nearly than vaccinated workers to be infected experiencing symptoms of infection,
300 hospitals and broader health with COVID–19 and transmit the virus will be permitted to spread the virus to
systems have implemented vaccine to others, and thus pose a heightened others at the workplace, including
mandates for their employees (Renton et risk of spreading the virus at the unvaccinated coworkers.
al., October 14, 2021). The White House workplace, including to other Additionally, OSHA finds it necessary
reported that almost 2,500 hospitals, unvaccinated workers. to require employers that do not
40% of all U.S. hospitals, across all 50 To reduce the risk that unvaccinated implement a mandatory vaccination
states, the District of Columbia, and workers will spread COVID–19 at the policy to ensure that unvaccinated
Puerto Rico, have announced workplace, this rule requires employers workers wear face coverings in most
vaccination requirements for their that do not implement a mandatory situations when they are working near
workforce, and noted numerous vaccination policy to ensure that others. This reflects OSHA’s recognition
examples of highly successful mandates unvaccinated workers who report to a that regularly testing unvaccinated
in those workplaces (White House, workplace where others are present are workers for COVID–19 will not be 100%
October 7, 2021). News reports attest tested at least once a week for COVID– effective in identifying infected workers
that many of these vaccination 19. As discussed in the Summary and before they enter the workplace. Most
mandates have had great success in Explanation for paragraph (g) (Section obviously, testing employees once a
increasing the vaccination rate of the VI.G. of this preamble), it is well- week will not prevent an unvaccinated
App. 38
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61439
worker from exposing others at the given that the agency has never Food and Drug Administration (FDA). (2020,
workplace if the worker becomes previously used its authority to strictly December 11). Emergency use
infected and reports to the workplace in mandate vaccination, and the exigent authorization for an unapproved product
review memorandum (Pfizer-BioNTech
between their weekly tests. And, even if and extraordinary circumstances driving COVID–19 vaccine/BNT 162b2 mRNA–
the rule required unvaccinated workers this emergency rulemaking have not 1273). https://www.fda.gov/emergency-
to be tested more frequently than once afforded OSHA a full opportunity to preparedness-and-response/coronavirus-
a week, infected persons may still be assess the potential ramifications of disease-2019-covid-19/pfizer-biontech-
missed, particularly in areas with high including a strict vaccination mandate covid-19-vaccine. (FDA, December 11,
community spread (Chin et al., in this rule. Given these circumstances, 2020)
September 9, 2020). and employers’ unique understanding of Food and Drug Administration (FDA). (2020,
Accordingly, requiring unvaccinated December 18). Emergency use
the compliance approaches that will
workers to wear face coverings in most authorization for an unapproved product
best increase vaccination rates among review memorandum (Moderna COVID–
situations when they are working near their workforce, OSHA has designed a 19 vaccine/mRNA–1273). https://
others will further mitigate the potential rule that preserves a limited degree of www.fda.gov/emergency-preparedness-
for unvaccinated workers to spread the employer flexibility, and strongly and-response/coronavirus-disease-2019-
virus at the workplace. As discussed in encourages, but does not strictly require, covid-19/moderna-covid-19-vaccine.
the Summary and Explanation for vaccination. OSHA has requested (FDA, December 18, 2020)
paragraph (i) (Section VI.I. of this comment in this ETS on whether a strict Food and Drug Administration (FDA). (2021,
preamble), it is well-established that February 26). Janssen COVID–19
vaccination mandate would be vaccine. Vaccines and Related Biological
face coverings provide effective source appropriate and the agency will Products Advisory Committee February
control; that is, they largely prevent consider those comments as it 26, 2021 Meeting Briefing Document.
respiratory droplets emitted by the determines how to proceed with this https://www.fda.gov/media/146219/
wearer of the face covering from rulemaking. download. (FDA, February 26, 2021)
spreading to others, and thus make it Goldberg C. (2021, July 9). Hospital Vaccine
significantly less likely that the person References Mandates Suggest Success in Boosting
wearing the mask will transmit the Beer T. (2021, October 4). COVID–19 Vaccine U.S. Shots. Bloomberg News. https://
virus, if they are infected. Face Mandates Are Working—Here’s The www.bloomberg.com/news/articles/2021-
coverings are also believed to provide Proof. Forbes. https://www.forbes.com/ 07-09/early-mandates-boost-worker-
sites/tommybeer/2021/10/04/covid-19- vaccine-rates-prompt-few-to-quit.
the wearer some limited protection from (Goldberg, July 9, 2021)
exposure to the respiratory droplets of vaccine-mandates-are-working-heres-
the-proof/?sh=1a08d2e72305. (Beer, Hirsch L. (2021, September 30). After
co-workers and others (e.g., customers) Mandate, 91% of Tyson Workers Are
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benefit of face coverings is to of asymptomatic and presymptomatic 2021/09/30/business/tyson-foods-
significantly reduce the wearer’s ability transmission in SARS–CoV–2 outbreak, vaccination-mandate-rate.html. (Hirsch,
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eid2704.204576. (Bender et al., February Are Working’: Employer Ultimatums Life
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the likelihood that an infected Times. https://www.nytimes.com/2021/
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community transmission: Systematic
workers than simply requiring all review and meta-analysis. Official 6). KFF COVID–19 Vaccine Monitor:
workers to be vaccinated. To be sure, Journal of the Association of Medical April 2021. https://www.kff.org/
OSHA strongly prefers that employers Microbiology and Infectious Disease coronavirus-covid-19/poll-finding/kff-
adopt a mandatory vaccination policy, Canada. 5(4): 223–234 doi:10.3138/ covid-19-vaccine-monitor-april-2021/.
as vaccination is singularly effective at jammi-2020-0030. (Byambasuren et al., (KFF, May 6, 2021)
protecting workers from the severe December 11, 2020) Kaiser Family Foundation (KFF). (2021, May
consequences that can result from a Centers for Disease Control and Prevention 17). How employer actions could
(CDC). (2021, May 7). Science brief: facilitate equity in COVID–19
COVID–19 infection. And, where vaccinations. https://www.kff.org/policy-
Community use of cloth masks to control
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consider alternative feasible measures science/science-briefs/masking-science- vaccinations/. (KFF, May 17, 2021)
that would remove employees who SARS-cov2.html. (CDC, May 7, 2021) Kaiser Family Foundation (KFF). (2021,
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vaccination mandate on all covered outbreaks. https://doi.org/10.1101/ campaign=COVID-19-vaccine-
employees who work in the presence of 2020.04.30.20087015. (Chin et al., monitor#messagesandinformation. (KFF,
others and not exclusively outdoors, September 9, 2020) September 2021)
App. 39
61440 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
Klompas M et al. (2021, September). The case www.whitehouse.gov/wp-content/ spread of the virus in workplaces.
for mandating COVID–19 vaccines for uploads/2021/10/Vaccination- Additionally, as mentioned previously,
health care workers. Annals of Internal Requirements-Report.pdf. (White House, other states have banned certain
Medicine. https://doi.org/10.7326/M21- October 7, 2021)
employers from implementing
2366. (Klompas et al., September 2021)
Lazer D et al. (2021, August). The COVID III. No Other Agency Action is Adequate workplace vaccination mandates or
States Project: A 50-State COVID–19 To Protect Employees Against Grave from verifying an employee’s
Survey Report #62: COVID–19 Vaccine Danger vaccination status or from requiring face
Attitudes Among Healthcare Workers. OSHA’s experience to date shows that coverings. A national standard is
http://news.northeastern.edu/uploads/
the agency’s existing tools are necessary to establish clear
COVID19%20CONSORTIUM%20 requirements regarding vaccination,
REPORT%2062%20HCW%20 inadequate to meet the grave danger
posed by COVID–19 to unvaccinated testing and face coverings that will
August%202021.pdf. (Lazer et al.,
workers not covered by the Healthcare protect employees in all states and
August, 2021)
National Academy for State Health Policy ETS. OSHA has determined that its preempt state or local ordinances that
(NASHP). (2021, October 1). State Efforts existing standards, regulations, the OSH prevent employers from implementing
to Ban or Enforce COVID–19 Vaccine Act’s General Duty Clause, and non- necessary protections.
Mandates and Passports. https:// mandatory guidance will not adequately
www.nashp.org/state-lawmakers-submit-
a. The Current Standards and
promote the most effective means to Regulations Are Inadequate
bills-to-ban-employer-vaccine-mandates/
. (NASHP, October 1, 2021)
protect these workers: Vaccination. The
National Safety Council (NSC). (2021, agency has determined that this ETS is In the Healthcare ETS, OSHA
September). A Year in Review, and necessary to address these inadequacies. considered its enforcement efforts with
What’s Next: COVID–19 Employer Multiple developments support this regard to existing standards and
Approaches and Worker Experiences. change in approach. First, large regulations that OSHA had identified as
https://www.nsc.org/faforms/safer-year- numbers of employees are continuing to potentially applicable to occupational
one-final-report. (NSC, September 2021) contract COVID–19 and die. (See Grave exposure to SARS–CoV–2. OSHA’s
Occupational Safety and Health Danger, Section III.A. of this preamble). analysis in Section IV of the Healthcare
Administration (OSHA). (2021c, Further, based on a thorough review of ETS, 86 FR 32376, 32416–17 and hereby
October). Health Impacts of the COVID–
its existing approach to protecting included in the record of this ETS,18 is
19 Vaccination and Testing ETS. (OSHA,
October 2021c) employees from COVID–19 and the applicable here in considering the need
Otterman S and Goldstein J. (2021, current state of the pandemic, OSHA for this ETS, which covers a much
September 28). Thousands of N.Y. finds that existing OSHA standards, broader set of employers in all
Health Care Workers Get Vaccinated regulations, the General Duty Clause, industries. There OSHA found that none
Ahead of Deadline. The New York and non-mandatory guidance are not of the existing OSHA standards could
Times. https://www.nytimes.com/2021/ adequate to protect employees outside sufficiently abate the hazard posed by
09/28/nyregion/vaccine-health-care- healthcare from COVID–19. The COVID–19 in healthcare settings. Here
workers-mandate.html. (Otterman and Preamble to the Healthcare ETS again OSHA concludes that the
Goldstein, September 28, 2021)
includes a detailed analysis potentially applicable existing standards
Renton B et al. (2021, October 14). New:
Hospital Vaccine Mandate Tracker. demonstrating the inadequacy of are insufficient to address the grave
Global Epidemics, Brown School of existing tools in the healthcare industry. danger faced by workers covered by this
Public Health. https:// See 86 FR 32414–32423. In general, the ETS. None of the current standards,
globalepidemics.org/2021/07/24/new- same analysis applies here. The reasons even if more rigorously enforced, can
hospital-vaccine-mandate-tracker/. existing tools were inadequate to protect sufficiently address this cross-industry
(Renton et al., October 14, 2021) healthcare workers apply in other hazard of national proportions to abate
Scobie HM et al. (2021, September 17). industry sectors as well. The Healthcare the grave danger posed by COVID–19 or
Monitoring Incidence of COVID–19 ETS itself, while necessary to protect lead to the same benefits that this ETS
Cases, Hospitalizations, and Deaths, by
healthcare workers, of course applies will achieve. See Asbestos Info. Ass’n/
Vaccination Status—13 U.S.
Jurisdictions, April 4–July 17, 2021. only to that industry. Finally, the N. Am. v. Occupational Safety & Health
MMWR Morb Mortal Wkly Rep 2021; 70: numerous guidance products published Admin., 727 F.2d 415, 427 (5th Cir.
early release. https://www.cdc.gov/ by other entities, such as CDC, are not 1984) (‘‘[M]uch of the claimed benefit
mmwr/volumes/70/wr/mm7037e1.htm. adequate to protect employees because could be obtained simply by enforcing
(Scobie et al., September 17, 2021) they are not enforceable; there is no the current standard.’’).
The Associated Press. (2021, September 22). penalty for noncompliance. 86 FR at Through its enforcement guidance,
United Airlines says 97% of US 32415. Even as the CDC has increasingly
employees have been vaccinated. https:// OSHA identified a number of current
recommended vaccination to protect standards and regulations that might
www.wifr.com/2021/09/22/united-
airlines-say-97-us-employees-have-been-
from the dangers of transmission and apply when workers have occupational
vaccinated/. (The Associated Press, severe illness related to the SARS–CoV– exposure to SARS–CoV–2, most of
September 22, 2021) 2 virus, vaccination rates remain uneven which are the same standards OSHA
Towey R. (2021, September 27). CNBC poll around the country. (CDC, September 9, considered in the Healthcare ETS.
shows very little will persuade 2021; Leonhardt, September 7, 2021; (Updated Interim Enforcement Response
unvaccinated Americans to get Covid KFF, October 6, 2021; McPhillips and Plan for Coronavirus Disease 2019
shots. https://www.cnbc.com/2021/09/ Cohen, May 19, 2021). (COVID–19)) (OSHA, July 7, 2021).
10/cnbc-poll-shows-very-little-will- The need for this ETS is also reflected
persuade-unvaccinated-americans-to- OSHA has also cited the Hazard
in the number of states and localities communication standard (29 CFR
get-covid-shots.html. (Towey, September
that have issued their own mandatory 1910.1200) during COVID–19
27, 2021)
White House. (2021, October 7). White House standards in recognition that OSHA’s investigations. Accordingly, a list of
Report: Vaccination Requirements Are existing measures (including non-
Helping Vaccinate More People, Protect mandatory guidance, compliance 18 This adoption includes the citations in the
Americans from COVID–19, and assistance, and enforcement of existing referenced section of the Healthcare ETS, which are
Strengthen the Economy. https:// standards) have failed to prevent the also included in the docket for this ETS.
App. 40
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61441
potentially applicable standards and OSHA again finds that none of these Fourth, existing recordkeeping and
regulations follows: existing standards provide for the types reporting regulations do not adequately
• 29 CFR part 1904, Recording and of workplace controls that are necessary allow the employer or the agency to
Reporting Occupational Injuries and to combat the grave danger addressed by assess the full scope of COVID–19
Illnesses. This regulation requires this ETS. First, none of the listed workplace exposures and protection.
certain employers to keep records of potentially applicable standards require OSHA’s general recordkeeping
work-related fatalities, injuries, and vaccination against SARS–CoV–2, the regulations were not written with the
illnesses and report them to the most efficient and effective control to nature of COVID–19 transmission or
government in specific circumstances. combat the grave danger posed by the illness in mind. In order to adequately
• 29 CFR 1910.132, General virus. (The Bloodborne Pathogen understand and thereby control the
requirements—Personal Protective Standard requires that the hepatitis B spread of COVID–19 in the workforce, it
Equipment (PPE). This standard vaccine be made available to certain is critical that the employer has records
requires that appropriate PPE, including employees, but that is not that is not of employees’ vaccination status, and of
PPE for eyes, face, head, and relevant here, since the hepatitis the testing undergone by employees
extremities, protective clothing, vaccine provides no protection against who do not receive vaccination, and
respiratory devices, and protective COVID–19). Nor are the additional that it knows of all cases of COVID–19
shields and barriers, be provided, used, safety measures included in this ETS— occurring among employees. However,
and maintained in a sanitary and vaccination verification, screening such information is outside of the scope
reliable condition. testing, face coverings, and medical of OSHA’s existing recordkeeping
• 29 CFR 1910.134, Respiratory removal of COVID–19 positive requirements, which are limited to
protection. This standard requires that workers— required by existing injuries or illnesses that the employer
employers provide, and ensure the use standards other than OSHA’s Healthcare knows to be work-related.
of, appropriate respiratory protection ETS (covering employees exempted Moreover, existing reporting
when necessary to protect employee from this new ETS while the Healthcare regulations do not adequately ensure
health. ETS is in effect). that OSHA has the full picture of the
• 29 CFR 1910.141, Sanitation. This impact of COVID–19 because those
standard applies to permanent places of Second, because existing standards do
not contain provisions specifically regulations only require employers to
employment and contains, among other report in-patient hospitalizations that
requirements, general housekeeping and targeted at the COVID–19 hazard, it may
occur within 24 hours of the work-
waste disposal requirements. be difficult for employers and
related incident and to report fatalities
• 29 CFR 1910.145, Specification for employees to determine what particular
that occur within thirty days of the
accident prevention signs and tags. This COVID–19 safety measures are required
work-related incident. 86 FR at 32417.
standard requires the use of biological by existing standards, or how the
Many COVID–19 infections will not
hazard signs and tags, in addition to separate standards are expected to work
result in hospitalization or death until
other types of accident prevention signs together as applied to COVID–19. An
well after these limited reporting
and tags. ETS that contains provisions
periods. Under existing regulations,
• 29 CFR Subpart U—COVID–19 specifically addressing COVID–19
such cases are not required to be
Emergency Temporary Standard. The hazards in covered workplaces will
reported to OSHA, which limits the
Healthcare ETS, promulgated on June provide clear instructions. More agency’s ability to fully understand the
21, 2021 includes various controls certainty will lead to more compliance, impact of COVID–19 on the workforce.
(patient screening and management, and more compliance will lead to 86 FR 32417. This ETS includes a
respirators and other PPE, limiting improved protection of employees provision, paragraph (k), that removes
exposure to aerosol-generating covered by this standard. the time limitation on reporting for
procedures, physical distancing, Third, requirements in some COVID–19 cases.
physical barriers, cleaning, disinfection, standards may be appropriate for other In conclusion, OSHA’s experience has
ventilation, health screening and situations but simply do not demonstrated that existing standards
medical management, access to contemplate COVID–19 and fail to and regulations are inadequate to
vaccination, anti-retaliation provisions, address important aspects of the hazard. address the current COVID–19 hazard.
and medical removal protection) to For example, the general sanitation
standard requires employers to provide b. The General Duty Clause Is
address the grave danger posed by
warm water, soap, and towels that can Inadequate To Meet the Current Crisis
COVID–19 to healthcare workers.
• 29 CFR 1910.1020, Access to be used in hand washing, but does not Section 5(a)(1) of the OSH Act, or the
employee exposure and medical require disinfection or provision of General Duty Clause, provides the
records. This standard requires that hand sanitizer where handwashing general mandate that each employer
employers provide employees and their facilities cannot be made readily ‘‘furnish to each of [its] employees
designated representatives access to available. See 86 FR 32417. Although employment and a place of employment
relevant exposure and medical records. the sanitation standard might appear at which are free from recognized hazards
• 29 CFR 1910.1200, Hazard first glance to be relevant here, it simply that are causing or are likely to cause
communication. This standard requires does not require the types of controls death or serious physical harm to [its]
employers to keep Safety Data Sheets that would, even if more rigorously employees.’’ 29 U.S.C. 654(a)(1). For
(SDS) for chemical hazards, provide enforced, sufficiently reduce the threat General Duty Clause citations to be
SDSs to employees and their of COVID–19 in the workplace. As such, upheld, OSHA must demonstrate
representatives when requested, and OSHA affirms its previous elements of proof that are
train employees about those hazards. determination that some of the above- supplementary to, and can be more
The standard does not apply to listed standards—including the difficult to show than, the elements of
biological hazards, but hazard sanitation standard—are in practice too proof required for violations of specific
communication becomes an issue for difficult to apply to the COVID–19 standards, where a hazard is presumed.
the SARS–CoV–2 virus when chemicals hazard and have never been cited in Specifically, to prove a violation of the
are used to disinfect surfaces. COVID enforcement. 86 FR 32416. General Duty Clause, OSHA needs to
App. 41
61442 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
establish—in each individual case— Integra Health Mgmt., Inc., 2019 WL abatement other than the one suggested
that: (1) An activity or condition in the 1142920, at *7 n.10 (No. 13–1124, 2019) by the Secretary.’’).
employer’s workplace presented a (noting that standards ‘‘give clear notice Further, even where OSHA
hazard to an employee; (2) the hazard of what is required of the regulated establishes a violation of the General
was recognized; (3) the hazard was community’’); 56 FR 64007 (‘‘because Duty Clause, the employer is under no
causing or was likely to cause death or the standard is much more specific than obligation to implement the feasible
serious physical harm; and (4) feasible the current requirements [general means of abatement proven by OSHA as
means to eliminate or materially reduce standards and the general duty clause], part of its prima facie case. Cyrus Mines
the hazard existed. BHC Nw. Psychiatric employers and employees are given Corp., 11 OSH Cas. (BNA) 1063, 1982
Hosp., LLC v. Sec’y of Labor, 951 F.3d more guidance in carrying out the goal WL 22717, at *4 (No. 76–616, 1983)
558, 563 (D.C. Cir. 2020). OSHA often of reducing the risks of occupational (‘‘[The employer] is not required to
relies on the General Duty Clause to fill exposure to bloodborne pathogens’’). adopt the abatement method suggested
gaps where specific standards do not by the Secretary, even one found
Moreover, several characteristics of
address a hazard and OSHA enforces it feasible by the Commission; it may
General Duty Clause enforcement
through case-by-case adjudicative satisfy its duty to comply with the
actions make them an inadequate means
proceedings. See United States v. standard by using any feasible method
to address hazards associated with
Strum, 84 F.3d 1, 5 (1st Cir. 1996). that is appropriate to abate the
COVID–19. First, it would be virtually
OSHA has previously found the violation.’’); Brown & Root, Inc., Power
impossible for OSHA to require and
General Duty Clause to be inadequate to Plant Div., 1980 WL 10668 at *5. Thus,
enforce the most important worker-
protect employees from dangers posed even in cases where OSHA prevails, the
protective elements of the ETS (such as
by infectious agents. In promulgating employer need not necessarily
vaccination and testing) under the implement the specific abatement
the bloodborne pathogens standard,
OSHA explained that enforcement General Duty Clause. Second, OSHA’s measure(s) OSHA established would
under the General Duty Clause was burden of proof for establishing a materially reduce the hazard. The
insufficient to protect employees from General Duty Clause violation is heavier employer could select alternative
the serious hazards those pathogens than for standards violations. Third, controls and then it would be up to
present. 56 FR 64007 (December 6, promulgating an ETS will enable OSHA OSHA, if it wished to cite the employer
1991). In the recently promulgated to issue more meaningful penalties for again, to establish that the recognized
Healthcare ETS, OSHA found that the willful and egregious violations, thus hazard continued to exist and that its
General Duty Clause was insufficient to creating effective deterrence against preferred controls could materially
protect healthcare workers from the employers who intentionally disregard reduce the hazard even further.
grave danger they faced as well. 86 FR their obligations under the Act or Given the severity and pervasiveness
32418. While OSHA initially attempted demonstrate plain indifference to of the COVID–19 hazard, OSHA has
to use the General Duty Clause to employee safety. As discussed in more determined that the specific abatement
protect employees across all industries detail below, all of these considerations measures provided in this ETS are
from COVID–19-related hazards, demonstrate OSHA’s need to necessary to protect workers from grave
OSHA’s experience has demonstrated promulgate this ETS in order to protect danger. Under the General Duty Clause
that the Clause is grossly inadequate to unvaccinated workers covered by this alone, it would be nearly impossible to
protect employees covered by this ETS standard from hazards posed by require employers to provide these
from the grave danger posed by COVID– COVID–19. specific measures, and even then, it
19 in the workplace. As explained more The General Duty Clause is ill-suited to could only be on a case-by-case
fully below, OSHA finds this ETS is requiring employers to adopt enforcement basis. Considering the
necessary to protect employees from the vaccination and testing policies, magnitude and ubiquity of the danger
hazards of COVID–19. like those required by the ETS that SARS–CoV–2 poses to workers
As an initial matter, the General Duty across the country, the case-by-case
Clause does not provide employers with Because the General Duty Clause adjudicatory regime set up through the
specific requirements to follow or a requires OSHA to establish the General Duty Clause is simply not
roadmap for implementing appropriate existence and feasibility of abatement adequate to combat the risk of severe
abatement measures. The ETS, however, measures that can materially reduce a illness and death caused by the virus.
provides a clear statement of what hazard, it is difficult for OSHA to use
the clause to require specific control General Duty Clause Citations Impose a
OSHA expects employers to do to
measures where an employer is doing Heavy Litigation Burden on OSHA
protect workers, thus facilitating better
compliance. The General Duty Clause is something, but not what the Secretary Under the General Duty Clause OSHA
so named because it imposes a general has determined is needed to fully must prove that there is a recognized
duty to keep the workplace free of address the serious hazard. See, e.g., hazard, i.e., a workplace condition or
recognized serious hazards; the ETS, in Waldon Health Care Center, 16 BNA practice to which employees are
contrast, lays out clear requirements for OSHC 1052, 1993 WL 119662 at * (No. exposed, creating the potential for death
employers to implement vaccination 89–2804, 1993) (vacating OSHA citation or serious physical harm to employees.
policies including vaccination requiring pre-exposure hepatitis B See SeaWorld of Florida LLC v. Perez,
verification, support for employee vaccination under General Duty Clause 748 F.3d 1202, 1207 (D.C. Cir. 2014);
vaccination, screening testing and face by finding that although vaccination Integra Health Management, 2019 WL
coverings for unvaccinated workers, and would more fully reduce the hazard, the 1142920, at *5. Whether a particular
medical removal of COVID–19 positive employer’s chosen means of abatement workplace condition or practice is a
employees. Conveying obligations as were sufficient); Brown & Root, Inc., ‘‘recognized hazard’’ under the General
clearly and specifically as possible Power Plant Div., 8 BNA OSHC 2140, Duty Clause is a question of fact that
makes it much more likely that 1980 WL 10668 at *5 (No. 76–1296, must be decided in each individual
employers will comply with those 1980) (‘‘[T]he employer may defend case. See SeaWorld of Florida LLC, 748
obligations and thereby protect workers against a section 5(a)(1) citation by F.3d at 1208. In the case of a COVID–
from COVID–19 hazards. See, e.g., asserting that it was using a method of 19-related citation, this means showing
App. 42
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61443
not just that the virus is a hazard as a Although OSHA had attempted to involved. See, e.g., Integra Health
general matter—a fairly indisputable address fire and explosion hazards in Management, 2019 WL 1142920, at *13
point—but also that the specific the grain handling industry under the (requiring expert witness to prove
conditions in the cited workplace, such General Duty Clause, ‘‘employers proposed abatement measures would
as unvaccinated, unmasked employees generally were successful in arguing materially reduce hazard). In contrast,
working in close proximity to other that OSHA had not proved that the where an OSHA standard specifies the
employees for extended periods, create specific condition cited could cause a means of compliance, the agency has
a COVID–19-related hazard. fire or explosion.’’ Id. at 721 & n.6 already made the necessary technical
In contrast, an OSHA standard that (citing cases holding that OSHA failed determinations in the rulemaking and
requires or prohibits specific conditions to establish a fire or explosion hazard therefore does not need to establish
or practices establishes the existence of under the General Duty Clause). The feasibility of compliance as part of its
a hazard. See Harry C. Crooker & Sons, Grain Handling Standard, in contrast, prima facie case in an enforcement
Inc. v. Occupational Safety & Health established specific limits on proceeding. See, e.g., A.J. McNulty & Co.
Rev. Comm’n, 537 F.3d 79, 85 (1st Cir. accumulations of grain dust based on its v. Sec’y of Labor, 283 F.3d 328, 334
2008); Bunge Corp. v. Sec’y of Labor, combustible and explosive nature, and (D.C. Cir. 2002); S. Colorado Prestress
638 F.2d 831, 834 (5th Cir. 1981). Thus, the standard allowed OSHA to cite Co. v. Occupational Safety & Health
in enforcement proceedings under employers for exceeding those limits Rev. Comm’n, 586 F.2d 1342, 1351 (10th
OSHA standards, as opposed to the without the need to prove at the Cir. 1978). Preventing the initial
General Duty Clause, ‘‘the Secretary enforcement stage that each cited exposure and protecting as many
need not prove that the violative accumulation was likely to cause a fire workers as quickly as possible is
conditions are actually hazardous.’’ or explosion. See id. at 725–26. especially critical in the context of
Modern Drop Forge Co. v. Sec’y of The same logic applies to COVID–19 COVID–19 because, as explained in
Labor, 683 F.2d 1105, 1114 (7th Cir. hazards. Given OSHA’s burden under Grave Danger, Section III.A. of this
1982). With OSHA’s finding that the the General Duty Clause to prove that preamble, it can spread so easily in
hazard of exposure to COVID–19 can conditions at the cited workplace are workplaces.
exist for unvaccinated workers in all hazardous, it is difficult for OSHA to
covered workplaces (see Grave Danger, ensure necessary abatement before The ETS will also permit OSHA to
Section III.A. of this preamble), the ETS individual employee lives and health achieve meaningful deterrence
will eliminate the burden to repeatedly are unnecessarily endangered by when necessary to address willful
prove, workplace by workplace, the exposure to COVID–19, despite or egregious failures to protect
existence of a COVID–19 hazard under widespread evidence of the grave employees against the COVID–19
the General Duty Clause. danger posed by worker exposure to hazard
One of the most significant COVID–19. Indeed, despite publishing a
advantages to standards like the ETS voluminous collection of COVID–19 As described above, in contrast to the
that establish the existence of the hazard guidance online and receiving and broad language of the General Duty
at the rulemaking stage is that the investigating thousands of complaints, Clause, this ETS will prescribe specific
Secretary can require specific abatement OSHA did not believe it could justify measures employers covered by this
measures without having to prove that the issuance of more than 20 COVID–19 standard must implement. This
a specific cited workplace is already related General Duty Clause citations specificity will make it easier for OSHA
hazardous.19 In contrast, as discussed over the entire span of the pandemic so to determine whether an employer has
above, under the General Duty Clause far, because of the quantum of proof the intentionally disregarded its obligations
the Secretary cannot require abatement Secretary must amass under the General or exhibited a plain indifference to
before proving in the enforcement Duty Clause. Unlike enforcement under employee safety or health. In such
proceeding that an existing condition at the General Duty Clause, this ETS instances, OSHA can classify the
the workplace is hazardous. For allows OSHA to cite employers for each citations as ‘‘willful,’’ allowing it to
example, in a challenge to OSHA’s protective requirement they fail to propose higher penalties, with increased
Grain Handling Standard, which was implement without the need to wait for deterrent effects. In promulgating the
promulgated in part to protect employee infection or death to prove in Healthcare ETS, OSHA noted that early
employees from the risk of fire and an enforcement proceeding that the in the pandemic, shifting guidance on
explosion from accumulations of grain particular cited workplace was the safety measures employers should
dust, the Fifth Circuit acknowledged hazardous without that particular take to protect their employees from
OSHA’s inability to effectively protect measure in place. Thus, this ETS, which COVID–19 created ambiguity regarding
employees from these hazards under the covers millions of workers nation-wide, employers’ specific obligations. Thus,
General Duty Clause in upholding, in is significantly preferable to the General OSHA could not readily determine
large part, the standard. See Nat’l Grain Duty Clause with respect to such a whether a particular employer had
& Feed Ass’n v. Occupational Safety & highly transmissible virus because the ‘‘intentionally’’ disregarded obligations
Health Admin., 866 F.2d 717, 721 (5th inability to prevent a single exposure that were not yet clear. And, even as the
Cir. 1988) (noting Secretary’s difficulty can quickly result in an exponential guidance began to stabilize, OSHA’s
in proving explosion hazards of grain increase in exposures and illnesses or ability to determine ‘‘intentional
handling under General Duty Clause). fatalities even at a single worksite. disregard’’ or ‘‘plain indifference’’ was
An additional limitation of the difficult, for example, when an
19 ‘‘The Act does not wait for an employee to die
General Duty Clause is that proving that employer took some steps address the
or become injured. It authorizes the promulgation there are feasible means to materially COVID–19 hazard. 86 FR 32420. The
of health and safety standards and the issuance of
citations in the hope that these will act to prevent reduce a recognized hazard typically Healthcare ETS largely resolved this
deaths and injuries from ever occurring.’’ Whirlpool requires testimony from an expert issue for employers covered by that
Corp, v. Marshall, 445 U.S. 1, 12 (1980); see also witness in each separate case, which standard, by laying out clearly what
Arkansas-Best Freight Sys., Inc. v. Occupational parameters to put in place to protect
Safety & Health Rev. Comm’n, 529 F.2d 649, 653
limits OSHA’s ability to prosecute these
(8th Cir. 1976) (noting that the ‘‘[OSH] Act is cases as broadly as needed to protect healthcare workers. However, this
intended to prevent the first injury’’). workers, in light of the expense general challenge persists in OSHA’s
App. 43
61444 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
attempts at enforcement in other use the General Duty Clause to address existing standards. 86 FR 32421. As
industries. this widespread hazard, OSHA finds explained above, that has not proven to
Further, OSHA has adopted its that the General Duty Clause is not an be an effective strategy. Moreover, when
‘‘egregious violation’’ policy to impose adequate enforcement tool to protect OSHA made its initial necessity
sufficiently large penalties that achieve employees covered by this standard determination at the beginning of the
appropriate deterrence against bad actor from the grave danger posed by COVID– pandemic, it made an assumption that
employers who willfully disregard their 19. given the unprecedented nature of the
obligation to protect their employees COVID–19 pandemic, there would be an
when certain aggravating circumstances c. OSHA and Other Entity Guidance Is
Insufficient unusual level of widespread voluntary
are present, such as a large number of compliance by the regulated community
injuries or illnesses, bad faith, or an OSHA has issued numerous non- with COVID–19-related safety
extensive history of noncompliance mandatory guidance products to advise guidelines. (See, e.g., DOL, May 29,
(OSHA Directive CPL 02–00–080 employers on how to protect workers 2020 at 20 (observing that ‘‘[n]ever in
(October 21, 1990)). Its purpose is to from SARS–CoV–2 infection (see the last century have the American
increase the deterrent impact of OSHA’s https://www.osha.gov/coronavirus). people been as mindful, wary, and
enforcement activity. This policy Even the most comprehensive guidance cautious about a health risk as they are
utilizes OSHA’s authority to issue a makes clear, as it must, that the now with respect to COVID–19,’’ and
separate penalty for each instance of guidance itself imposes no new legal that many ‘‘protective measures are
noncompliance with an OSHA standard, obligations, and that its being implemented voluntarily, as
such as each employee lacking the same recommendations are ‘‘advisory in reflected in a plethora of industry
required protections, or each nature.’’ (See OSHA’s online guidance, guidelines, company-specific plans, and
workstation lacking the same required Protecting Workers: Guidance on other sources’’)).
controls. It can be more difficult to use Mitigating and Preventing the Spread of
COVID–19 in the Workplace (OSHA, Since that time, however,
this policy under the General Duty
Updated August 13, 2021); and OSHA’s developments have led OSHA to
Clause because the Fifth Circuit and the
earlier 35-page booklet, Guidance on conclude that the same uneven
Occupational Safety and Health Review
Preparing Workplaces for COVID–19, compliance documented by CDC, IOM,
Commission have held that, under the
(OSHA, March 9, 2020)). This guidance, and WHO is also occurring for the
General Duty Clause, OSHA may only
as well as guidance products issued by COVID–19 guidance issued by OSHA
cite a hazardous condition once,
regardless of its scope or the number of other government agencies and and other agencies. For example, rising
workers affected. Reich v. Arcadian organizations, including the CDC, the ‘‘COVID fatigue’’ or ‘‘pandemic fatigue’’
Corp., 110 F.3d 1192, 1199 (5th Cir. Centers for Medicare & Medicaid has been reported for nearly a year
1997). Thus, even where OSHA finds Services (CMS), the Institute of already—i.e., a decrease in voluntary
that an employer willfully failed to Medicine (IOM), and the World Health use of COVID–19 mitigation measures
protect a large number of employees Organization (WHO), help protect over time (Meichtry et al., October 26,
from a COVID–19 hazard, OSHA might employees to the extent that employers 2020; Silva and Martin, November 14,
not be able to cite the employer on a voluntarily choose to implement the 2020; Belanger and Leander, December
per-instance basis for failing to protect practices they recommend. 9, 2020; Millard, February 18, 2021).
each of its employees. The provisions of Unfortunately, OSHA’s experience and Other reasons that people have not
this ETS have been intentionally drafted the continued spread of COVID–19 followed COVID–19 guidance include
to make clear OSHA’s authority to throughout the country shows that does fear of financial loss; skepticism about
separately cite employers for each not happen consistently or rigorously the danger posed by COVID–19; and
instance of the employer’s failure to enough, resulting in inadequate even a simple human tendency, called
protect employees and for each affected protection for employees. For example, ‘‘psychological reactance,’’ to resist
employee, where appropriate. the CDC has strongly recommended curbs on personal freedoms, i.e., an urge
By providing needed clarity, the ETS vaccination since vaccines became to do the opposite of what somebody
will facilitate ‘‘willful’’ and ‘‘egregious’’ widely available earlier in the year, but tells you to do (Belanger and Leander,
determinations that are critical many employees have yet to take this December 9, 2020; Markman, April 20,
enforcement tools OSHA can use to simple step, which would protect 2020). OSHA is seeing evidence of these
adequately address violations by themselves and their co-workers from trends in its COVID–19 enforcement.
employers who have shown a conscious the danger of COVID–19. For example, although OSHA has issued
disregard for the health and safety of As documented in numerous peer- guidance since the spring of 2020
their workers in response to the reviewed scientific publications, CDC, encouraging the use of physical
pandemic. Without the necessary IOM, and WHO have recognized a lack distancing and barriers as a means of
clarity, OSHA has been limited in its of compliance with non-mandatory protecting employees at fixed work
ability to impose penalties high enough recommended infection-control locations, there have been a number of
to motivate the very large employers practices (Siegel et al., 2007; IOM, 2009; news reports indicating that employers
who are unlikely to be deterred by WHO, 2009). As noted in the preamble ignore that guidance (Romo, November
penalty assessments of tens of to the Healthcare ETS, OSHA was aware 19, 2020; Richards, May 5, 2020; Lynch,
thousands of dollars, but whose of these findings when it previously July 9, 2020). This was evidenced by a
noncompliance can endanger thousands concluded that an ETS was not cross-sectional study performed from
of workers. Indeed, OSHA has only been necessary, but at the time of that late summer to early fall of 2020 in New
able to issue two COVID–19-related conclusion, the agency erroneously York and New Jersey that found non-
‘‘willful’’ citations and no ‘‘egregious’’ believed that it would be able to compliance and widespread
citations since the start of the pandemic effectively use the non-mandatory inconsistencies in COVID–19 response
because of the challenges described guidance as a basis for establishing the programs (Koshy et al., February 4,
above. mandatory requirements of the General 2021). Indeed, OSHA continues to
For all of the reasons described above, Duty Clause, and informing employers receive complaints and referrals
and after over a year of attempting to of their compliance obligations under attesting to such workplace practices.
App. 44
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61445
(OSHA, October 17, 2021). Worse, some significant reduction in COVID–19- the workplace. Currently, the spectrum
employers must now deal with related complaints from employees. ranges from states and localities
employees who not only have yet to be The dramatic increases in the requiring vaccine mandates and face
vaccinated but compound the danger by percentage of the population that coverings to states prohibiting or
hiding their unvaccinated status and contracted the virus during the summer restricting them, with many states
declining to wear source protection that of 2021 indicates a continued risk of falling somewhere in between. Due to
would identify them as unvaccinated, COVID–19 transmission in workplace uneven approaches to vaccination
even though it could provide some settings (for more information on the across the country, states with the
protection to their coworkers, in prevalence of COVID–19 see Grave lowest rates of vaccination have
workplaces where there is a stigma Danger, Section III.A. of this preamble) COVID–19 infection rates four times as
attached to being unvaccinated. (Ember despite OSHA’s publication of high as in states with the highest
and Murphy Marcos, August 7, 2021). numerous specific and comprehensive vaccine rates. (Leonhardt, September 7,
This ETS contains notification and guidance documents. OSHA has found 2021). Given that thousands of working
vaccine verification requirements that that neither reliance on voluntary action age people continue to be infected with
address these avoidant behaviors and by employers nor OSHA non-mandatory COVID–19 each week, many of whom
mitigate the hazard of undisclosed guidance is an adequate substitute for will become hospitalized or die, OSHA
exposure and transmission (see the specific, mandatory workplace recognizes that a patchwork approach to
Summary and Explanation for standards at the federal level. Public worker safety has not been successful in
paragraphs (e), (g), and (h), Sections Citizen v. Auchter, 702 F.2d 1150 at mitigating this infectious disease
VI.E., VI.G., and VI.H. of this preamble). 1153 (voluntary action by employers outbreak (CDC, October 18, 2021—
OSHA’s more recent guidance update ‘‘alerted and responsive’’ to new health Cases, By Age). It has become clear that
encourages employers to facilitate data is not an adequate substitute for a Federal standard, by way of this ETS,
employee vaccination by providing paid government action). is necessary to provide clear and
time off and encourages testing and consistent protection to employees
d. A Uniform Nationwide Response to
masks for unvaccinated workers. across the country. As explained in
the Pandemic Is Necessary To Protect
However, as discussed previously, Pertinent Legal Authority (Section II. of
Workers
vaccination rates remain inconsistent this preamble) and the Summary and
across the country and have slowed As the pandemic has continued in the
Explanation for paragraph (a) (Section
significantly since the spring of 2021. United States, there has been increasing
VI.A. of this preamble), OSHA has the
And infection rates remain high, recognition of the need for a more
authority to comprehensively address
especially among the unvaccinated. It is consistent national approach (GAO,
the issue(s) described in this ETS, and
clear, as discussed previously, that September, 2020; Budryk, November 17,
2020; Horsley, May 1, 2020; DOL OIG, the standard is intended to preempt
voluntary self-regulation by employers conflicting state and local laws.
will not sufficiently reduce the danger February 25, 2021). Many employers
that COVID–19 poses in workplaces have advised OSHA that they would In sum, based on its enforcement
covered by this standard. As noted in welcome a nationwide ETS. For experience during the pandemic to date,
the White House Report on vaccination example, in its October 9, 2020 petition OSHA concludes that continued
requirements released on October 7, at for a COVID–19 ETS, ORCHSE reliance on existing standards and
this time only 25% of businesses have Strategies, LLC explained that it is regulations, the General Duty Clause,
vaccine mandates in place (White ‘‘imperative’’ that OSHA issue an ETS to and guidance, in lieu of an ETS, is not
House, October 7, 2021). Since this ETS provide employers one standardized set adequate to protect unvaccinated
and other federal efforts to require of requirements to address safety and employees from the grave danger of
vaccination were announced more health for their workers (ORCHSE, being infected by, and suffering death or
private and public sector institutions October 9, 2020). This group of serious health consequences from,
have begun to prepare to implement prominent business representatives COVID–19.
vaccination requirements, further explained that an ETS would eliminate
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an impetus for employer action (White workplaces that are struggling to Belanger J and Leander P. (2020, December
House, October 7, 2021). understand how best to protect their 9). What Motivates COVID Rule
The high number of COVID–19- employees in the face of confusing and Breakers? Scientific American. https://
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localities. what-motivates-covid-rule-breakers/.
OSHA continues to receive on a regular
The lack of a national standard on this (Belanger and Leander, December 9,
basis suggests a lack of widespread 2020)
compliance with existing voluntary hazard has led to increasing imbalance Budryk Z. (2020, November 17). Fauci calls
guidance: From March 2020 to October in state and local regulation, a problem for ‘a uniform approach’ to coronavirus
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hundreds of COVID–19-related concerning in its Healthcare ETS. See 86 policy/healthcare/526378-fauci-calls-for-
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400 complaints during the month of state and local regulations led to pandemic?rl=1. (Budryk, November 17,
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Horsley S. (2020, May 1). U.S. Workplace Administration (OSHA). (2021, July 7). Workers’ Safety at Increased Risk. http://
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Vaccinations by Race/Ethnicity. https:// Mitigating and Preventing the Spread of strengthen the economy. https://
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brief/latest-data-on-covid-19- uploads/2021/10/Vaccination-
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Occupational Safety and Health
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17). Summary Data for Federal and State
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doi.org/10.1016/j.ssci.2021.105193. www.ncbi.nlm.nih.gov/books/
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Leonhardt D. (2021, September 7). One in
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www.nytimes.com/2021/09/07/briefing/ Labor—Occupational Safety and Health
Administration (OSHA) for an IV. Conclusion
risk-breakthrough-infections-delta.html.
(Leonhardt, September 7, 2021) Emergency Temporary Standard (ETS) This pandemic continues to take a
Lynch R. (2020, July 9). Orange County to for Infectious Disease.’’ (ORCHSE, massive toll on American society, and
crack down on gyms that ignore Covid- October 9, 2020) addressing it requires a comprehensive
19 safety guidelines. Orlando Business Richards C. (2020, May 5). 2 Utah County national response. This ETS is part of
Journal. https://www.bizjournals.com/ businesses told staff to ignore COVID–19
that response. OSHA shares the nation’s
orlando/news/2020/07/09/orange- guidelines, resulting in 68 positive cases.
Daily Herald. https:// hope for the promise of recovery created
county-gyms-could-face-scrutiny-for- by the vaccines. But in the meantime, it
not.html. (Lynch, July 9, 2020) www.heraldextra.com/news/local/2-
Markman A. (2020, April 20). Why are there utah-county-businesses-told-staff-to- recognizes that we have not yet
still so many coronavirus skeptics? Fast ignore-covid-19-guidelines-resulting-in- succeeded in defeating the virus, and
Company. https:// 68-positive/article_d8426991-a693-5879- that many workers across the country
www.fastcompany.com/90492518/why- 9d88-f9e094aef5b5.html. (Richards, May are in grave danger. Therefore, this ETS,
are-there-still-so-many-coronavirus- 5, 2020) with mitigation measures emphasizing
skeptics. (Markman, April 20, 2020) Romo V. (2020, November 19). Tyson worker vaccination, is necessary.
McPhillips D and Cohen E. (2021, May 19). managers suspended after allegedly
Although OSHA finds it necessary to
Uneven vaccination rates across the US betting if workers would contract
COVID. National Public Radio. https:// institute specific mitigation measures
linked to COVID–19 case trends, worry
experts. CNN Health. https:// www.npr.org/2020/11/19/936905707/ for the immediate future, the agency can
www.cnn.com/2021/05/19/health/ tyson-managers-suspended-after- adjust as conditions change. Even after
uneven-vaccination-rates-covid-19- allegedly-betting-if-workers-would- issuing an ETS, OSHA retains the
trends/index.html. (McPhillips and contract-covid. (Romo, November 19, flexibility to update the ETS to adjust to
Cohen, May 19, 2021) 2020) the subsequent evolution of CDC
Meichtry S et al. (2020, October 26). Siegel J, Rhinehart E, Jackson M, Chiarello L, workplace guidance. This ETS
Pandemic Fatigue is Real—And It’s and the Healthcare Infection Control addresses (and incorporates as a main
Spreading; Collective exhaustion with Practices Advisory Committee. (2007).
component) the major development in
coronavirus restrictions has emerged as a 2007 Guideline for isolation precautions:
formidable adversary for governments. Preventing transmission of infectious infection control over the last year—the
The Wall Street Journal. https:// agents in healthcare settings. https:// development and growing
www.wsj.com/articles/pandemic-fatigue- www.cdc.gov/infectioncontrol/pdf/ implementation of COVID–19 vaccines.
is-realand-its-spreading-11603704601. guidelines/isolation-guidelines-H.pdf. Going forward, further developments
(Meichtry et al., October 26, 2020) (Siegel et al., 2007) can be addressed through OSHA’s
App. 46
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61447
authority to modify the ETS if needed, implemented, or were in process of federal governmental bodies. While
or to terminate it entirely if vaccination implementing, procedures similar to OSHA discusses several examples of
and other efforts end the current those required by the Healthcare ETS. these plans and policies below,20
emergency. However, at this point in Similarly, OSHA’s feasibility findings OSHA’s feasibility determination is
time, the available evidence indicates for this ETS are based on evidence that based on all evidence in the rulemaking
that the ETS is necessary to protect vaccination and testing policies, along record. The majority of the survey data
unvaccinated employees across the with the use of face coverings consistent and other publicly available material
country from the grave danger of with recommendations from the CDC, that OSHA reviewed pertains to large
COVID–19. have been implemented in multiple employers with 100 or more employees.
industry sectors as testing and Additionally, OSHA thoroughly
IV. Feasibility vaccinations were made more widely reviewed current and future projections
A. Technological Feasibility available during the course of the of the availability of COVID–19 tests,
pandemic. testing supplies, and laboratory
This section presents an overview of
As discussed in Summary and capacity. Based on a review of
the technological feasibility assessment
Explanation (Section VI. of this vaccination and testing policies among
for OSHA’s Emergency Temporary preamble), this ETS for vaccination and large employers, OSHA has determined
Standard (ETS) for COVID–19 that testing applies to all employers with 100 that most employers covered by this
requires all employers with 100 or more or more employees, except as noted standard across a wide range of
employees to ensure that all employees here. It does not apply to workplaces industries have either already
are fully vaccinated unless they covered under the Safer Federal implemented vaccination and testing
implement a policy requiring employees Workforce Task Force COVID–19 programs and require unvaccinated
to undergo testing for COVID–19 at least Workplace Safety: Guidance for Federal employees to wear face coverings, or are
once every seven days and wear face Contractors and Subcontractors or capable of implementing programs that
coverings. settings where any employee provides comply with the requirements in the
Technological feasibility has been healthcare services or healthcare ETS most of the time. OSHA therefore
interpreted broadly to mean ‘‘capable of support services when subject to the finds that the standard is
being done’’ (Am. Textile Mfrs. Inst. v. requirements of the Healthcare ETS (29 technologically feasible.
Donovan, 452 U.S. 490, 509–510 CFR 1910.502). It also does not apply to
(1981)). A standard is technologically I. Employer Policy on Vaccination
employees who do not report to a
feasible if the protective measures it workplace where other individuals such Paragraph (d)(1) of the ETS requires
requires already exist, can be brought as coworkers or customers are present, each covered employer to establish and
into existence with available employees while they are working from implement a written mandatory
technology, or can be created with home, or employees who work vaccination policy unless the employer
technology that can reasonably be exclusively outdoors. adopts an alternative policy requiring
expected to be developed, i.e., As noted above, OSHA has the legal COVID–19 testing and face coverings for
technology that ‘‘looms on today’s duty to demonstrate that the average unvaccinated employees, which is
horizon’’ (United Steelworkers of Am., employer covered by this ETS can discussed later. To meet the definition
AFL–CIO–CLC v. Marshall, 647 F.2d comply with that standard in most of ‘‘mandatory vaccination policy’’
1189, 1272 (D.C. Cir. 1980) (Lead I)); operations most of the time. This legal under paragraph (c), the policy must
Amer. Iron & Steel Inst. v. OSHA, 939 analysis is therefore focused solely on require: Vaccination of all employees,
F.2d 975, 980 (D.C. Cir. 1991) (Lead II); whether employers with 100 or more including all new employees as soon as
American Iron and Steel Inst. v. OSHA, employees can comply with the practicable, other than those employees
577 F.2d 825 (3d Cir. 1978)). Courts standard. OSHA’s rationale for that (1) for whom a vaccine is medically
have also interpreted technological scope threshold of 100 or more contraindicated, (2) for whom medical
feasibility to mean that a typical firm in employees is explained in the Summary necessity requires a delay in
each affected industry or application and Explanation for paragraph (b), vaccination, or (3) those legally entitled
group will reasonably be able to Section VI.B. of this preamble. to a reasonable accommodation under
implement the requirements of the As discussed below, OSHA finds no federal civil rights laws because they
standard in most operations most of the technological feasibility barriers related have a disability or sincerely-held
time (see Public Citizen v. OSHA, 557 to compliance with the requirements in religious beliefs, practices, or
F.3d 165 (3d Cir. 2009); Lead I, 647 F.2d the ETS. These requirements include observances that conflict with the
at 1272; Lead II, 939 F.2d at 990). establishing and implementing a written vaccination requirement.
OSHA issued an ETS in June 2021 to mandatory COVID–19 vaccination OSHA requires employers to
protect healthcare and healthcare policy or alternative policy requiring implement a mandatory vaccination
support employees in covered testing and face coverings; determining requirement, but provides an exemption
healthcare settings from exposure to employee vaccination status; supporting for an alternative policy that allows
SARS–CoV–2. See 86 FR 32376 (June employee vaccination by providing paid employees to choose either to be fully
21, 2021) (Healthcare ETS). OSHA time for vaccination and time off for vaccinated or to be regularly tested and
found the requirements in that ETS to recovery; ensuring that employees who wear a face covering. This compliance
be technologically feasible, including a are not fully vaccinated are tested for options mean that the ETS is
requirement for employers to pay for COVID–19 at least once every seven
vaccination of employees that is very days and wear face coverings; and 20 While OSHA references several employers’
policies, this is not intended to serve as an
similar to the requirement in this new recordkeeping for employee vaccination endorsement of those plans or an indication that
ETS. OSHA’s finding that the status and testing. those plans comply with the ETS. Rather, the plans
Healthcare ETS was technologically OSHA reviewed numerous large-scale and best practice documents show that developing
feasible was primarily based on employer surveys and vaccination and and implementing policies to address employee
COVID–19 vaccination in various workplaces is
available evidence showing that most testing policies developed by capable of being done in a variety of industries, and
healthcare employers, and employers employers, public health organizations, therefore, compliance with the ETS is
across all industry sectors, had already trade association, and local, state, and technologically feasible.
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61448 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
technologically feasible if employers service; hotels and casinos; called SAFER, aimed at helping
across various industries are capable of transportation, distribution, and employers prioritize health and safety as
implementing either policy, but logistics; consumer transportation; and they develop plans and polices for their
nevertheless OSHA analyzes both recreation (ASU WEF, September 2021). employees to return to the workplace
employer policy options to demonstrate The survey responses related to (NSC, May 17, 2021). Through SAFER,
that there are no significant vaccination policies support OSHA’s the NSC and HAA developed a web-
technological barriers to either determination that it is feasible for based decision tool to guide employers
approach. covered employers to implement on health, legal, and other
OSHA reviewed several large-scale mandatory COVID–19 vaccination considerations to prioritize the health
employer surveys related to vaccination policies. The survey results showed that and safety of workers. Due to the Delta
policies across the country covering a 45% of employers surveyed require all Variant surge of new COVID–19 cases
wide range of industry sectors. Surveys employees to be vaccinated against across the United States, the NSC and
conducted by Arizona State University COVID–19, and an additional 16% HAA revised the SAFER resources,
(ASU) and the World Economic Forum require some of its employees to be including the online tool, to include
(WEF), called COVID–19 Workplace vaccinated against COVID–19. (ASU information about employer
Commons—Keeping Workers Well, WEF, September 2021). Only three requirements for COVID–19
show that most employers already have percent of employers surveyed did not vaccinations. These include guides for
some type of vaccination policy, with have a vaccination policy at the time developing plans and policies to
more than 60 percent of surveyed (ASU WEF, September 2021). While this support employee vaccination through
employers requiring vaccinations for survey covers a wide range of industries mandates and incentives; the collection
some or all employees. These survey it may not represent the percentage of and maintenance of COVID–19
results further support OSHA’s companies implementing mandatory vaccination records; and various
determination that the vaccination vaccination policies in general considerations for testing unvaccinated
policy requirement is feasible. populations but for the feasibility workers. (HAA and NSC, September 17,
The ASU WEF workplace COVID–19 purposes it demonstrates that it has and 2021). The availability of these publicly-
surveys collected information from can be done. accessible tools to help employers
employers across industry sectors about OSHA also reviewed slightly older develop vaccination policies further
their response to the COVID–19 survey data, which, even though it reduces any potential barriers for
pandemic. The results and responses shows somewhat lower rates of covered employers to establish and
from more than 1,400 companies are employer vaccination mandates, still implement a written policy requiring
publicly available through the ASU supports OSHA’s finding that such each employee to be fully vaccinated
College of Health Solutions web page vaccination polices are feasible. In late against COVID–19, or alternatively to
COVID–19 Diagnostics Commons (ASU, June 2021, the National Safety Council
establish a policy allowing employees to
October 5, 2021). Case studies from (NSC) conducted three national surveys,
choose whether to be fully vaccinated or
employers are also available within the one organizational and two workforce,
tested for COVID–19 at least every seven
interactive dashboard on that web page. of private companies, nonprofits, legal
days and wear face coverings.
The surveys consisted of numerous experts, public health professionals, The HAA maintains an online list of
questions about workplace pandemic medical professionals and government large companies requiring vaccinations
response, including questions related to agencies that have addressed workforce for all or part of their workforce or
vaccination policies and testing COVID–19 vaccinations based on best customers. OSHA reviewed the list of
unvaccinated employees. practices and proven workplace safety
companies, drawn from news reports
The most recent COVID–19 survey strategies. The survey results show that
and employer websites, with
data was collected between August 2, many employers and organizations are
2021 and August 20, 2021 and reported requirements for COVID–19 vaccination.
currently requiring employees to be
in September 2021 (accessible through Most of the companies listed require
vaccinated.
the COVID–19 Workplace Commons). The three surveys were distributed to some or all employees to be vaccinated
More than 1,400 companies operating 300 employers and organizations across against COVID–19 while allowing
1143 facilities in 23 industry sectors the country and from a wide range of medical exemptions or reasonable
were part of the survey, the majority of industries to collect data on pandemic accommodations for disability or
which are companies of the size covered response, including implementation of religious reasons. There are currently
by the ETS. Ninety percent of facilities COVID–19 vaccine policies and testing 188 listed companies across numerous
surveyed had 100 or more employees at among their workforce. Of the industry sectors, including Amtrak,
their facilities, and 56% had more than employers and organizations surveyed Deloitte, Google, The Walt Disney
100 but less than 1,000 employees at in June 2021, the NSC found that 20% Company, Walmart, and the U.S.
their facilities. The industry sectors were implementing some form of a Chamber of Commerce.21
surveyed include: Technology and worker vaccination requirement. While While healthcare employers subject to
software; business and professional OSHA believes that the ASU WEF 29 CFR 1910.502 are not covered by this
services; manufacturing; construction; surveys (which included more ETS, a number of large healthcare
healthcare, hospitals, and clinics; retail employers and are more recent) are employers have implemented
stores; retail food stores; consumer retail better indicators of current employer mandatory vaccine policies. This also
service; energy and utilities; nonprofit vaccination policies, the NSC surveys shows the feasibility of the employers
organizations; education (colleges and also support the feasibility of employer implementing mandatory vaccination
universities); education (pre-K to 12); vaccination mandates (NSC, September requirements, often on large scales.
real estate and property management; 2021) According to the American Hospital
agriculture and food production; The NSC, in partnership with the Association (AHA), over 1,800 hospitals
healthcare services; media and Health Action Alliance (HAA) and the 21 https://www.healthaction.org/resources/
entertainment; government and quasi- Centers for Disease Control and vaccines/covid-19-vaccines-employer-requirements-
public; biotech, pharmaceuticals, and Prevention (CDC), have developed a health-action-alliance?0405d6f4_page=1 (last
diagnostics; restaurants and food multifaceted, comprehensive effort visited October 2, 2021).
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61449
have one or more vaccination for personnel in health care settings vaccination status. This information is
requirements in place (Becker’s Hospital with high-risk patients. All personnel subject to applicable legal requirements
Review, October 11, 2021). Large affected by this rule needed to receive for confidentiality of medical
healthcare employers mandating that their first dose of COVID–19 vaccine by information. These records must be
their employees be vaccinated include September 30, 2021, and must be fully preserved while the ETS is in effect.
Kaiser Permanente, the nation’s largest vaccinated by October 31, 2021 (CDPHE, OSHA is not aware of any technological
integrated, nonprofit health care September 17, 2021). challenges that the large employers
organization with more than 216,000 A number of local governments have covered by this ETS would face with
employees and more than 23,000 also implemented policies requiring respect to collecting and maintaining
physicians (Kaiser Permanente, August COVID–19 vaccination or testing for records. This is a performance-based
2, 2021); Trinity Health, one of the employees. For example, the Fulton requirement, meaning that employers
largest multi-institutional Catholic County Board of Commissioners in have the flexibility to structure their
health care delivery systems in the Georgia recently approved a ‘‘Vax or systems to fit within current systems,
nation, with more than 123,000 Test’’ policy requiring employees to get such as those relating to personnel
employees and 90 hospitals in 22 states vaccinated or tested for COVID–19 each records, tax records, and other sensitive
(Trinity Health, July 8, 2021); Sanford week. Since September 6, 2021, Fulton or confidential records gathered and
Health, which operates in 26 states and County has required all County maintained by large employers.
employs nearly 50,000 people (Sanford employees, as a condition of A number of the surveys discussed
Health, July 22, 2021); and Genesis employment, to either be vaccinated above also show that most employers
Health Care, a large U.S. nursing home against COVID–19 or be tested weekly with vaccine mandates require proof of
chain with over 40,000 employees for COVID–19 unless an employee is vaccination. For example, ASU WEF
working in more than 250 centers across granted a reasonable accommodation workplace COVID–19 survey from fall
23 states (Genesis Health Care, (Fulton County Government, September 2021 found that 60% of employers that
September 29, 2021). 03, 2021). The multitude of local, state, required vaccinations also required
Under paragraph (d)(2), if employers and employer vaccination or testing proof of vaccination from employees.
do not establish and implement a mandates across the country support The NSC study from June 2021 found
written mandatory vaccination policy, OSHA’s finding that such policies are that 45% of employers with COVID–19
the employer must establish and feasible. vaccination requirements required proof
implement a written policy allowing of vaccination, such as submitting a
II. Determining Employee Vaccination
any employees not subject to a copy of the COVID–19 vaccination card.
Status
mandatory vaccination policy to either An additional 30% of employers
choose to be fully vaccinated or Paragraph (e) of the ETS requires surveyed verify employee vaccination
regularly tested for COVID–19 and wear employers to determine the vaccination status through self-reporting based on
a face covering. A substantial number of status of each employee. Employers the honor system.
employers already have such policies in must require employees to provide an Additionally, a large-scale survey
place. For example, the ASU WEF acceptable proof of vaccination status, conducted by the Willis Towers Watson
survey shows that 30% of employers including whether they are fully or consulting firm between August 18 and
surveyed require unvaccinated partially vaccinated. As discussed in 25, 2021, showed that a majority of
employees to participate in mandatory Summary and Explanation (Section VI. employers currently track their
COVID–19 testing and 30% of of this preamble), acceptable proof of employees’ vaccination status. Nearly
employers require face coverings for vaccination status is: (i) The record of one thousand employers responded to
unvaccinated employees (ASU WEF, immunization from a health care this survey, and they collectively
September 2021). provider or pharmacy; (ii) a copy of the employ 9.7 million workers from
OSHA also notes a number of state COVID–19 Vaccination Record Card; industries across the public and private
COVID–19 vaccination requirements. In (iii) a copy of medical records sectors including manufacturing,
response to the Delta Variant surge, 19 documenting the vaccination; (iv) a general services, wholesale and retail, IT
states have implemented written copy of immunization records from a and telecom, healthcare, financial
COVID–19 vaccination and testing public health, state, or tribal services, energy and utilities, and public
policies for state employees and 23 immunization information system; or a sector and education (Willis Towers
states have done so for healthcare copy of any other official Watson, June 23, 2021). Nearly six in 10
employees (NASHP, October 1, 2021). documentation that contains the type of (59%) currently track their workers’
For example, on September 20, 2021, vaccine administered, date(s) of vaccination status and another 19% are
the Colorado Department of Public administration, and the name of the planning or considering doing so later
Health and Environment (CDPHE) health care professional(s) or clinic this year. A majority (62%) of those
implemented policies requiring state site(s) administering the vaccine(s). A employers who currently track their
employees and personnel at health care signed and dated employee attestation is workers’ vaccination status require
facilities and hospitals to be fully acceptable in instances when an proof of vaccination, such as CDC
vaccinated against COVID–19. All state employee is unable to produce proof of vaccination cards, while 36% rely on
employees must either be fully vaccination. Given the attestation employees to self-report (Willis Towers
vaccinated against COVID–19 or option, there are no technological Watson, September 1, 2021).
participate in twice-weekly testing. barriers to the provision for proof of Other evidence in the record also
Employees are allowed work time to get vaccination status. As discussed below, supports the feasibility both of gathering
tested and administrative or Public many employers requiring proof of proof of vaccination and determining
Health Emergency Leave to get vaccination have successfully employees’ vaccination status. Many
vaccinated. Employees who are not fully implemented such policies even large employers with vaccination
vaccinated must wear masks inside state without allowing the flexibility of the policies require employees to submit
facilities when they are around others. attestation option. proof of vaccination. For example,
On August 30, 2021, the State Board of The employer must maintain a record Tyson Foods requires employees to
Health approved a vaccine requirement and a roster of each employee’s submit proof of vaccination to Tyson
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61450 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
Foods Vaccination Verification Program that 60% of employers surveyed offered present are: (1) Tested for COVID–19 at
in order to qualify for the company’s incentives for employees to be least once every seven days; and (2)
vaccination incentive (Tyson Foods, vaccinated. These incentives ranged provide documentation of the most
August 3, 2021). Similarly, Capital One from additional paid time off, cash, the recent COVID–19 test result to the
bank requires all employees, ability to bypass regular testing and/or employer no later than the seventh day
contractors, vendors, and visitors to daily health screening requirements, following the date the employee last
Capital One facilities to show proof of and gifts. Eighteen percent of surveyed provided a test result. Employers must
vaccination. (Capital One, August 11, employers already provide additional also ensure that employees who are not
2021). The International Union of time off for COVID–19 vaccination. fully vaccinated and do not report
Painters and Allied Trades (IUPAT), Moreover, the NSC survey found that during a period of seven or more days
which represents 140,000 craftspeople 86% of surveyed organizations had to a workplace where other individuals
in the U.S. and Canada and has implemented policies such as paid time are present are: (1) Tested for COVID–
implemented vaccine requirements for off, assistance with scheduling and 19 within seven days prior to returning
its members, also requires all of its own transportation, and/or onsite to the workplace; and (2) provide
non–bargaining unit office and field vaccination. documentation of that test result upon
employees to show proof of vaccination. OSHA’s review of plans and best return to the workplace.
(IUPAT, May 10, 2021). practice documents from the HAA Employees who are not fully
CVS Health, a health conglomerate registry and from other publicly- vaccinated must be tested with a
with more than 300,000 employees, available sources also inform OSHA’s COVID–19 test, which is a test for
including more than 40,000 physicians, finding that it is feasible for large SARS–CoV–2 that is: (i) Cleared,
pharmacists, nurses and nurse employers to support employee approved, or authorized, including in an
practitioners, has mandated COVID–19 vaccination (HAA, October 10, 2021). Emergency Use Authorization (EUA) by
vaccination for its nurses, pharmacists As part of this review, OSHA analyzed the U.S. Food and Drug Administration
and other employees who interact with the ways that employers are currently (FDA) to detect current infection with
patients and requires proof of supporting employee vaccination. One the SARS–CoV–2 virus (e.g., a viral
vaccination for those employees (CVS employer in the restaurant industry, the test); (ii) administered in accordance
Health, August 23, 2021). Fifty/50 Group, a Chicago-based with the authorized instructions; and
The surveys and employer policies restaurant group comprised of 14 (iii) not both self-administered and self-
reviewed by OSHA all support the establishments that requires employees read unless observed by the employer or
agency’s finding that it is feasible for to be fully vaccinated, offers paid time an authorized telehealth proctor.
employers to determine their off for anyone getting a vaccine or Examples of tests that satisfy this
employees’ vaccination status and feeling the mild after-effects. (Fifty/50 requirement include tests with
collect proof of vaccination. Group, May 18, 2021). Another specimens that are processed by a
III. Providing Support for Vaccination employer in the animal slaughtering and laboratory (including home or on-site
processing industry, Tyson Foods, collected specimens which are
Paragraph (f) of the ETS requires requires COVID–19 vaccinations for its processed either individually or as
employers to support COVID–19 U.S. workforce and also offers $200 and pooled specimens), proctored over-the-
vaccination for each employee by up to four hours of regular pay if counter tests, point of care tests, and
providing a reasonable amount of time employees are vaccinated outside of tests where specimen collection is either
to each employee for vaccination and their normal shift or through an external done or observed by an employer.
reasonable time and paid sick leave to source (Tyson Foods, August 3, 2021). COVID–19 testing has become more
each employee for side effects In addition, Tyson Foods supports widely available throughout the
experienced following vaccination. The onsite vaccination events in pandemic and as of September 2021, the
feasibility of paying for the time is collaboration with local health FDA has authorized approximately 250
addressed in OSHA’s economic departments and healthcare providers to tests and collection kits that diagnose
analysis. improve accessibility to vaccination. current infection with the SARS–
This technological feasibility Tyson Foods has hosted more than 100 CoV–2 virus and may be acceptable
determination focuses on whether vaccination events at its locations across under the ETS (FDA, September 10,
employers would encounter obstacles in the country. 2021), and by October 1, 2021, the
implementing payment policies that The evidence in the record number of EUAs issued had grown to
would make this requirement infeasible demonstrates that many employers are 324 (FDA, October 1, 2021). The ETS
for the large employers covered by this already offering the types of vaccination permits compliance through use of a
ETS. OSHA has determined that there support required by paragraph (f). wide range of FDA-authorized tests that
are no such obstacles. Most Combined with OSHA’s previous are readily available, so there is little
significantly, OSHA has already finding for a similar provision in the doubt that testing itself is
required this type of system for Healthcare ETS and the lack of technologically feasible.
employers covered by the Healthcare compliance difficulties reported while This technological feasibility analysis
ETS and nearly four months after that that ETS has been in effect, OSHA therefore focuses on whether testing
ETS took effect, OSHA is not aware that therefore finds this requirement is will continue to be readily available in
employers covered by that ETS technologically feasible. quantities sufficient to meet the
experienced any technological potential increase in testing demand
compliance difficulties with respect to IV. COVID–19 Testing for Employees while this ETS is in place. Given the
that requirement. In addition, many Who Are Not Fully Vaccinated wide variety of tests that can be used to
employers have already implemented Paragraph (g) of the ETS requires comply with this ETS and OSHA’s
policies such as those required to employers to ensure that employees review of information about the existing
comply with this new ETS as a way of who are not fully vaccinated and who manufacturing and distribution
incentivizing employee vaccination. For report at least once every seven days to capabilities of test manufacturers, the
example, the ASU WEF workplace a workplace where other individuals agency does not anticipate feasibility
COVID–19 survey from fall 2021 found such as coworkers or customers are issues related to ensuring that
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61451
employees can get access to one of the the facility is operating under a CLIA employers (797 employers) had testing
acceptable tests within the time frames certificate of waiver. A CLIA certificate policies for their workforce, and 76% of
required by the ETS. of waiver can be issued by CMS and those employers had implemented
may, when consistent with FDA’s mandatory testing requirements.
a. Brief Overview of Testing and
authorization, allow a laboratory to run Additionally, 25% of employers with
Administration
a SARS–CoV–2 test outside a high or testing polices had implemented
COVID–19 tests that are cleared, moderate complexity traditional clinical requirements for routine testing of a
approved, or authorized, including in an laboratory setting (CDC, September 9, portion of or the entire workforce, and
Emergency Use Authorization (EUA), by 2021). In accordance with the CLIA 41% no longer require testing for fully
the FDA to detect current infection with certificate of waiver, the laboratory or vaccinated employees. Of the employers
the SARS–CoV–2 virus (e.g., a viral test) POC testing site must use a test that test employees, 27% of those
satisfy the ETS. FDA-cleared, approved, authorized for that location, like an FDA perform viral testing daily and 46%
or authorized molecular diagnostic tests EUA POC test, and must adhere to the perform viral test once a week. Finally,
and antigen tests are permitted under authorized test instructions to avoid 38% of companies exclusively
the ETS when used as authorized by the human error. Certain COVID–19 antigen administer polymerase chain reaction
FDA and with a Clinical Laboratory diagnostic tests can be analyzed on-site (PCR) tests (PCR tests are a type of
Improvement Amendments of 1988 (where the person took the nasal swab) NAAT), 17% exclusively administer
(CLIA) certification when appropriate. when that facility is operating under a antigen tests, and 45% administer both.
As described in the Summary and CLIA certificate of waiver, while others Companies administer a range of
Explanation for paragraph (g) (Section must be analyzed in a CLIA certified COVID–19 tests and conduct testing at
VI.G. of this preamble), NAATs are a high or moderate complexity laboratory a variety of locations (some companies
type of molecular test that detect genetic setting. Some COVID–19 antigen use more than one location). Forty-two
material. As of October 14, 2021, the diagnostic tests are authorized for use at percent of companies test workers at
FDA had issued EUAs for 264 molecular home, without the need to send a health testing laboratories, 35% test
COVID–19 tests including tests sample to a laboratory. Antigen tests onsite at work, 28% test at hospitals,
specified to be used ‘‘with certain generally return results in 23% test at retail pharmacies, 13% test
conditions of authorization required of approximately 15–30 minutes. The CDC at universities, 9% test at home to be
the manufacturer and authorized provides training materials created by sent a lab for evaluation, and 5% test at
laboratories’’, 81 of which are test manufacturers for POC antigen home for immediate results (ASU WEF,
authorized for home collection. testing and reading of results for SARS– September 2021).
Additionally, the FDA has issued EUAs CoV–2 (CDC, July 8, 2021). OSHA also evaluated evidence of
for 2 OTC molecular COVID–19 test kits COVID–19 antigen diagnostic tests are employers’ current testing efforts by
available without a prescription (FDA, found at physician offices; urgent care reviewing existing COVID–19 practices
October 14, 2021b). facilities; pharmacies, such as CVS or developed by employers, trade
NAATs, such as real-time reverse Walgreens; school health clinics; long- associations, and other organizations.
transcription-polymerase chain reaction term care facilities and nursing homes; Based on its review, OSHA concludes
(RT–PCR), have greater accuracy than temporary locations, such as drive- that it is feasible for most covered
antigen tests. However, most FDA- through sites managed by local employees (and therefore their
authorized NAATs need to be processed organizations; and other locations across employers) to be tested in compliance
in a laboratory certified under the the country (CDC, July 8, 2021; CVS with the ETS requirements for
Clinical Laboratory Improvement Health, October 2021; Walgreens, frequency of testing.
Amendments of 1988 (referred to as a October 8, 2021). The availability of OSHA notes that there are several
‘‘CLIA-certified laboratory’’) with government-offered antigen tests varies options for large employers to consider
variable time to results (∼1–2 days). by state, and may be free or subsidized if they want to help facilitate testing for
While the NAAT test is a more reliable and accessible without a prescription or employees who are not vaccinated.
test, the antigen test is faster and less physician note (RiteAid, October 2021; Delta Airlines, for example, currently
expensive. Walgreens, October 2021; HHS, June 11, requires weekly COVID–19 testing for
An antigen test is an in vitro 2021). The Department of Health and all of its employees who are not
diagnostic test used to detect active Human Services (HHS) provides a vaccinated, and the company has
SARS–CoV–2 infection. As of October publicly-available list of community- engaged the Mayo Clinic Laboratories to
14, 2021, the FDA had issued 37 EUAs based testing locations in each state that help design the employee testing
for COVID–19 antigen tests, including offer free COVID–19 testing for insured program, assist in administering
eight EUAs for over-the-counter (OTC) and uninsured residents (HHS, August diagnostic and serology tests, and
antigen tests that can be used without a 17, 2021). Pharmacies and other analyze the results to determine broader
prescription (FDA, October 14, 2021a). locations often provide antigen tests by trends and provide recommendations to
Administration of an antigen test that appointment, although some will allow Delta’s existing policies and procedures
meets the definition of COVID–19 test testing for walk-ins (CVS Health, (Mayo Clinic Laboratories, June 30,
under this ETS falls into one of several September 2021; Walgreens, October 8, 2020). Delta Airlines also operates
categories: OTC employee self-tests that 2021). COVID test kits are currently onsite testing in cities with large
are observed by employers or authorized available from several on-line retailers employee populations including
telehealth proctors; point-of-care (POC) (Amazon, October 12, 2021). Atlanta, Minneapolis, and New York. It
or OTC tests performed by employers recently extended an at-home specimen
with a CLIA certificate of waiver; and b. Testing Frequency collection option to all U.S. employees,
other FDA cleared, approved, or The ASU WEF survey data also through which Quest Diagnostics will
authorized antigen tests that are supports OSHA’s finding that the send self-collection kits directly to an
analyzed in a CLIA certified laboratory requirement for employees who are not employee’s doorstep upon request and
setting (FDA, October 14, 2021a). The fully vaccinated to be tested at least support complete laboratory
FDA has authorized POC tests that can every seven days is feasible. The ASU confirmation for results (Delta, August
be used at a place of employment when WEF found that 73% of survey surveyed 25, 2021).
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61452 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
c. Availability of COVID–19 Tests August 2021, the period of the summer below, because of the substantial
In the spring and early summer including the Delta Variant surge and investments made, OSHA projects that
months of 2021, demand for tests other reasons for substantial testing the diagnostic testing capacity can meet
decreased as vaccinations began to increases such as re-opening of schools, the increased demand due to this ETS.
was approximately 87 million tests, an OSHA evaluated multiple projections
increase and the number of COVID–19
average of approximately 6.7 million per of current and future testing capacity
cases declined before the Delta surge
week (JHU, October 8, 2021). During and determined that projections related
and some manufacturers slowed
that period, more than 400 million to the NIH initiatives discussed below
production of COVID–19 tests.
COVID–19 tests were produced through are the most reliable estimates of current
However, the number of tests performed
the NIH RADx initiative, or roughly 33 and future testing capacity for its
daily has grown considerably over the
million per week. OSHA anticipates that technological feasibility assessment.
summer due to the Delta Variant surge
this surplus of tests will continue to Test manufacturers receiving NIH, FDA,
and re-openings of workplaces and
increase the availability of tests that can and Biomedical Advanced Research and
schools. In parallel with the Delta surge, Development Authority (BARDA) (a
be used to comply with the ETS.
COVID–19 testing has increased from a The data from the Johns Hopkins component of HHS) funding as part of
daily average of about 450,000 in early Coronavirus Resource Center is these programs undergo a submission
July 2021 to about 1.8 million by mid- collected from state and county and authorization process where their
September 2021, or roughly 12.6 million government sources, so it does not production capacity and pipeline are
per week (JHU, October 8, 2021). This include any self-administered OTC assessed and production quantities are
data does not include any self- tests. Additionally, while all states validated. As explained below, as of
administered OTC tests, which will be report PCR testing, not all states report August 2021, the NIH data indicates
discussed below. antigen testing. Nevertheless, the data testing capacity stands at about 30
OSHA’s review of the evidence shows from Johns Hopkins Coronavirus million tests per week, and capacity
that the increasing rate of production of Resource Center is the best available continues to grow (NIBIB, September
COVID–19 tests is more than adequate evidence from which to estimate the 28, 2021). OSHA notes that this number
to meet rising demand related to total number of tests administered underestimates the total number of tests
compliance with the ETS testing option during a given period of time. Even available each week, as it only includes
before the 60-day delayed testing though the number of administered tests companies that have received funding
compliance date (see paragraph reported through the Johns Hopkins for tests and testing supplies through
(m)(2)(ii)). This determination is largely Coronavirus Resource Center does not the NIH initiatives described below.
based on the number of tests with FDA include unreported OTC tests, the NIH The NIH has identified constraints on
EUAs actively being produced through RADx program data shows a large testing capacity as an area of focus and
the National Institutes of Health (NIH) surplus and sufficient additional investment since the beginning of the
Rapid Acceleration of Diagnostics COVID–19 test capacity relative to the COVID–19 pandemic, and OSHA
(RADx) initiative described below. number of administered tests reported. examined potential constraints on
According to the Johns Hopkins Additionally, the NIH RADx program testing capacity as part of its feasibility
University of Medicine Coronavirus will further allow for increased test analysis. As described below, massive
Resource Center, the total tests distribution through retail markets and investments in testing capabilities,
administered in August 2021 was will address any increase in demand particularly in underserved areas, have
approximately 44.4 million (or due to companies that may stockpile largely mitigated issues with the
approximately 11.1 million per week). tests. This increased availability will availability of COVID–19 tests. Further,
Id. During that same month, the total strengthen test capacity, further testing capacity continues to grow as
tests produced by the NIH RADx enabling compliance with the ETS new tests are developed and brought to
contracts was approximately 121 testing provision (NIBIB, September 28, market and manufacturers can ramp up
million (which would average to 30.25 2021). OSHA has determined that even supply to meet any future testing
million per week), resulting in a with an estimated additional 7.2 million demands if need be.
substantial surplus of available tests tests administered weekly due to the The FDA has authorized more than
(NIBIB, September 28, 2021). As ETS (see Economic Analysis (Section 320 tests and collection kits that
discussed in Economic Analysis, IV.B. of this preamble)), there are diagnose current infection with the
Section IV.B. of this preamble, Table sufficient COVID–19 tests available to SARS–CoV–2 virus and may be
IV.B.8, OSHA estimates that as many as allow for both employers and employees acceptable under the ETS (FDA, October
7.2 million tests may be administered to obtain COVID–19 tests through a 1, 2021). Among other criteria, the
weekly under this standard; however, variety of retail sources (e.g., local standard allows for the use of tests with
7.2 million is almost certainly an pharmacies, on-line purchasing as specimens that are processed by a CLIA
overestimate because it does not discussed above). certified laboratory (including home or
exclude employees who are already Determinations of testing capacity are on-site collected specimens which are
required to be tested by their employers aggregate measures of domestic and processed either individually or as
and would continue to be tested at the global market and supply chains. pooled specimens), proctored over-the-
same frequency after the ETS. Even if Throughout the pandemic, diagnostic counter tests, point of care tests, and
testing is increased by 7.2 million tests testing capacity has been stressed by the tests where specimen collection and
per week because of the ETS, that would increased demand, as some products processing is either done or observed by
still mean a surplus of nearly 12 million that are part of a global market cannot an employer. As explained above, many
tests per week beyond what would be adapt by simply increasing employers across various industry
need to continue at current testing manufacturing in one country (e.g., sectors have already implemented
levels with the addition of ETS-related laboratory instruments), and other policies for onsite testing. The use of
tests (30.25 ¥ 11.1 ¥ 7.2 = 11.95 products manufactured domestically FDA-authorized POC tests by these
million surplus per week). require capital investments to address employers would be compliant with the
The total number of tests rising demands (e.g., extraction kits) testing provision of the ETS if the entity
administered during June, July, and (CRS, February 25, 2021). As discussed administering the test holds a CLIA
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61453
certificate as required by the EUA. the RADx Tech program and determined another $70 million contract for
COVID–19 OTC tests that are both self- that the initiatives had succeeded in manufacturing Capacity Scale-Up for
administered and self-read by dramatically increasing COVID–19 Sofia SARS Antigen and Sofia Influenza
employees do not satisfy the testing testing capacity in the United States. A+B/SARS FIAs on June 11, 2021 (FDA,
requirement unless observed by the The IEEE report found that the RADx June 11, 2021).
employer or an authorized telehealth Tech/ATP programs, in conjunction The RADx-TECH/ATP initiative
proctor. In the event that the employer with BARDA and the FDA, had maintains a dashboard of manufacturer
is merely observing the employee streamlined and bolstered the national testing data from supported U.S. firms.
conduct a test, a CLIA certificate would COVID–19 testing capacity. At the time OSHA reviewed the data available on
not be needed. of the report, the RADx Tech/ATP the dashboard as part of its
There have been extensive programs had increased the number of determination of feasibility. In August
investments, including by the federal testing makers to 150 companies that, as 2021, the data showed that U.S.
government, to help ensure that COVID– a result of the NIH/BARDA investments, manufacturers supported by the NIH
19 tests are widely available. Section had the capacity to produce up to 1.9 RADx-TECH/ATP were producing
2401 of the American Rescue Plan million tests per day (IEEE, April 28, approximately 30 million tests per week
appropriated $47,800,000 to the 2021). (NIBIB, September 28, 2021).
Secretary of the HHS, to remain The NIH RADx-TECH/ATP initiative While consumers in some parts of the
available until expended, to carry out entered its second phase on September country have encountered difficulty
activities to detect, diagnose, trace, and 28, 2021, and at that time the supported obtaining rapid at-home tests, on
monitor SARS–CoV–2 and COVID–19 companies had collectively produced October 4, 2021, the FDA granted EUA
infections and related strategies to over 500 million tests, received 27 FDA for the ACON Laboratories Flowflex
mitigate the spread of COVID–19. Funds authorizations, and developed the first COVID–19 Home Test, which is
were made available to implement a OTC COVID–19 test for use at home. anticipated to double rapid at-home
national testing strategy; provide These September 2021 investments are testing capacity in the United States
technical assistance, guidance, support, supporting late stage development of within weeks (and well before
and awards grants or cooperative innovative point-of-care and home- compliance dates for testing required by
agreements to State, local, and territorial based tests, as well as improved clinical this ETS) (FDA, October 4, 2021). By the
public health departments; and support laboratory tests that will increase the end of the 2021 (ahead of the paragraph
the development, manufacturing, capacity of testing in the U.S. A full list (g) compliance date), the manufacturer
procurement, distribution, and of active contracts and supported U.S. plans to produce more than 100 million
administration of tests to detect or COVID–19 testing manufacturers can be tests per month and plans to produce
diagnose SARS–CoV–2 and COVID–19; found on the NIH RADx-TECH/ATP more than 200 million tests per month
and establish federal, state, local and programs: Phase 2 awards (NIBIB, by February 2022 (FDA, October 4,
territorial testing capabilities. October 14, 2021). 2021). On October 6, 2021, the
On April 29, 2020, the NIH The following example shows the NIH Administration announced a plan to
established the RADx initiative with a RADx EUA pipeline process. On May 9, buy $1 billion worth of rapid at-home
$1.5 billion investment. The RADx 2020, the FDA authorized the first EUA COVID–19 tests; this purchase, coupled
initiative has used this funding to speed for a COVID–19 antigen test, a new with the October 4 authorization of the
development of rapid and widely- category of tests for use in the ongoing Flowflex COVID–19 test, is expected to
accessible COVID–19 testing (NIH, April pandemic. Quidel was awarded a increase the number of available at-
29, 2020). On October 6, 2020, the NIH contract under the NIH RADx TECH/ home COVID–19 tests to 200 million per
and BARDA established the RADx ATP phase 1 initiative for the Sofia 2 month by December 2021 (Washington
Technology (RADx-Tech) and RADx SARS Antigen FIA for use in high and Post, October 6, 2021).
Advanced Technology Platforms (RADx- moderate complexity laboratories These investments have had a
ATP) programs to speed innovation in certified by CLIA, as well as for point- pronounced impact on the availability
the development, commercialization, of-care testing by facilities operating of testing and employers’ use of testing
and implementation of technologies for under a CLIA certificate of waiver (FDA, in the workplace. ASU’s recent report,
COVID–19 testing specifically for late- May 9, 2020). On July 31, 2020, Quidel How Work has Changed: The Lasting
stage scale-up projects. Through the announced that it had received a Impact of COVID–19 on the Workplace,
RADx Tech and RADx-ATP programs, contract for $71 million under the NIH ascribed the jump in the percentage of
the NIH and BARDA have awarded a RADx TECH/ATP program, phase 1, to employers that test their employees
total of $476.4 million in manufacturing accelerate the expansion of its from 17% in the fall of 2020 to 70% in
expansion contracts supporting a manufacturing capacity for production the fall of 2021 in large part to the
combined portfolio of 22 companies in of the SARS–CoV–2 rapid antigen test increased availability of testing. In
the U.S. (NIH, October 6, 2020). and quickly exceeded that capacity particular, the report noted that by the
These programs have significantly (Quidel Corp., July 31, 2020). On March spring of 2021, ‘‘it became relatively
increased testing capacity throughout 31, 2021, the FDA then authorized a easy to acquire tests and hire testing
the country. Since being established, second EUA from Quidel under contract service providers. There are more labs
RADx has worked closely with the FDA, with the NIH RADx initiative for the and companies with EUA’s and most
the CDC, and BARDA to move more QuickVue At-Home OTC COVID–19 have enough capacity that there are few
advanced diagnostic technologies Test, another antigen test where certain shortages.’’ (ASU WEF, September
swiftly through the development individuals can rapidly collect and test 2021).
pipeline toward commercialization and their sample at home, without needing Moreover, to ensure a broad,
broad availability. On April 28, 2021, to send a sample to a CLIA certifed sustained capacity for COVID–19 test
the Institute of Electrical and Electronic laboratory for analysis (FDA, March 31, production, multiple COVID–19 test
Engineers (IEEE) dedicated a special 2021). Furthermore, based on the manufacturers have been mobilized by
issue in the Journal of Engineering in success of the Quidel for the Sofia 2 authority of the Defense Production Act.
Medicine and Biology exploring the SARS Antigen FIA increasing Under the Administration’s plan to
innovative structure and operation of production capacity, the NIH granted increase COVID–19 testing, the federal
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61454 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
government will directly purchase and up for review for NIH/BARDA funding. laboratory COVID–19 tests is rising
distribute 280 million- rapid point-of- Furthermore, 517 of these submissions across the country.
care and over-the-counter at-home are for the authorization and production Testing for COVID–19 involves many
COVID–19 tests, sending 25 million free of multiple types of COVID–19 tests different components that are
at-home rapid tests to community health including one or more of the following: manufactured, transported, and used
centers and food banks. These actions Blood, sputum, nasal swab, oral swab, independently (e.g., bulk solvents,
will provide tests for use by fecal, saliva, or other types. OSHA extracting reagents, packaging) or semi-
communities to build adequate considers this to be further support for independently (e.g., test kits). Most of
stockpiles, as well as the sustained its determination that testing capacity the supplies used in COVID–19 testing
production to be able to scale up will continue to grow and that increased are disposable, requiring a constant
production as needed in the future. COVID–19 testing supplies are on the sustained capacity for new supplies.
Additionally, to ensure convenient horizon (NIBIB, September 28, 2021). Some distribution channels move
access to free testing, 10,000 pharmacies Based on data from the Johns Hopkins supplies directly to medical and
will be added to the Department of Coronavirus Resource Center, which laboratory end-users and others move
Health and Human Services free testing examined publicly-available data from supplies through distributors. In either
program. multiple sources, approximately 12.4 case, the combination of increased
In response to rising demands for million tests were conducted during the testing demand and the established
testing, U.S. manufacturers have week of August 26–September 2, 2021. supply chains indicate that testing kits
increased production of COVID–19 test As noted earlier, in the economic will be available in sufficient quantities
kit, reagents, and supplies. Advanced analysis of this ETS, OSHA projects throughout the country, including in
Medical Technology Association testing rates to increase by rural areas where large employers may
(AdvaMed), a trade group for testing approximately 7.2 million tests per be located.
manufacturers, reported that its week starting 60 days after publication There have been substantial
members are ramping up production of of the ETS. As described above, many investments from federal and state
rapid point-of-care test supplies to meet employers are currently testing their programs and private industry to
demand and that laboratory-based workforce. This 7.2 million is almost stimulate the production and
testing capacity for test confirmation is certainly an overestimate because it distribution of testing supplies to bolster
strong. AdvaMed has created a national does not exclude employees who are testing capacity across the country.
COVID–19 Diagnostic Supply Registry already required to be tested by their Many products, such as swabs and
of COVID–19 test manufacturers that employers and would continue to be reagents for RNA extraction kits,
support state and federal governments tested at the same frequency after the exhibited rising demand and, at some
in their pandemic responses. Registry ETS. The data reviewed by OSHA on point during the pandemic, were subject
participants are thirteen leading the RADx-TECH/ATP Dashboard shows to shortages that threatened continued
diagnostic manufacturers whose tests that the manufacturers supported by the testing capacity. For example, there was
together comprise approximately 75– initiative are producing approximately only one domestic manufacturer of
80% of the COVID–19 in vitro 30 million tests per week, and capacity medical grade flocked swabs, Puritan
diagnostic devices (IVD) on the market continues to grow. As explained above, Medical Products Company of Guilford,
in the U.S. While these manufacturers it is expected that roughly 50 million at- Maine, and the company’s pre-
produce a majority of molecular home COVID–19 tests will be available pandemic capacity was insufficient to
COVID–19 tests, they do not produce a each week by December 2021. OSHA meet demand of increased testing in the
majority of the total COVID–19 tests therefore finds that there are (and will early period of the COVID–19 pandemic
manufactured. These COVID–19 test continue to be) sufficient COVID–19 (Puritan Products, April 20, 2020). On
manufacturers collectively shipped tests available to meet the anticipated July 29, 2020, the Department of
approximately 3.8 million tests in July demand related to compliance with Defense (DOD), in coordination with the
2021, 8.2 million tests in August 2021, paragraph (g) by the 60-day delayed Department of Health and Human
and 9.4 million molecular tests for the compliance date. Services, awarded $51.15 million to
week ending September 4th, 2021 Puritan to expand industrial production
d. Availability of COVID–19 Test capacity of flock tip testing swabs (DOD,
(AdvaMed, September 10, 2021). While
Supplies July 31, 2020). On March 26, 2021,
these figures are not representative of
the total weekly testing capacity in the OSHA has also analyzed the Puritan was awarded another $146.77
U.S., this data demonstrates that testing availability of COVID–19 test supplies million to increase the company’s total
capacity has grown significantly over for use by COVID–19 test kit production capacity to 250 million foam
the past few months and reflects the manufacturers, diagnostic laboratories, tip swabs per month at its Tennessee
success manufacturers have had in and determined that there are sufficient facility by February 2022 (DOD, March
ramping up production of tests. supplies to allow compliance with the 29, 2021).
While current test availability is ETS testing option. The COVID–19 Other private sector companies were
sufficient to meet the increased testing pandemic and recent Delta Variant mobilized to change the products they
demands due to the ETS, OSHA is also surge have caused some disruptions in manufactured to accelerate production
confident that the RADx-TECH/ATP the availability of testing supplies such of COVID–19 test components, such as
initiatives will continue to spur testing as swabs, viral transport medium, RNA swabs, reagents, and solvents for RNA
capacity and growth. The RADx-TECH/ extraction kits, serology consumables, extraction kits. For example,
ATP initiatives have focused on moving diagnostic reagents, plastic Microbrush, a U.S.-based manufacturer
test makers’ products through the late consumables, and diagnostic of sterile applicators for the dental
stage pipeline and securing FDA instruments. The COVID–19 testing industry, began production of a
authorization for entry into the market. supply market is driven by the need to nasopharyngeal test swab to meet the
So far, there have been 27 such rapidly screen large segments of the growing demand for COVID–19 testing
authorizations. As of September 2021, population and deliver test results. The requirements in July 2020. The
there were 824 eligible late-stage scale data presented throughout this Microbrush test swabs are sterilized and
up proposals from various test makers assessment has shown demand for individually packaged in a medical-
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61455
grade pouch intended for any potential disruption of COVID–19 regions where demand is comparatively
nasopharyngeal sample collection such testing capacity (Millipore Sigma, high and has implemented an online
as in dental procedures and also October 2021). In light of the foregoing, consumer-initiated test service for
COVID–19 testing (Microbrush, July 1, OSHA believes that there is sufficient— individuals and small businesses to
2020). and increasing—availability of COVID– request COVID–19 testing. In August
RNA extraction kits are used by the 19 testing supplies to enable compliance 2021, Quest Diagnostics began to offer
majority of NAAT protocols. These kits with the ETS testing option. clinician-guided rapid COVID–19
are sets of consumable plastic laboratory antigen testing to employers through a
materials (small centrifuge tubes, filters, e. Sufficiency of Laboratory Capacity
guided telehealth visit using a self-
and collection vials) and chemical As noted above, a wide range of tests administered, nasal swab antigen test
reagents (solutions for breaking the are acceptable under the ETS, including that provides results in 15 minutes that
virus apart and purification) assembled those that can be observed by employers is then shipped to a Quest Diagnostics
by a manufacturer. Each kit has enough without laboratory processing. lab for confirmation (Quest Diagnostics,
materials to process several dozen Moreover, there has been rapid growth September 28, 2021).
samples. The use of RNA extraction kits in the availability of OTC tests that do Based on the evidence reviewed,
is not exclusive to COVID–19 testing, not require laboratory processing. OSHA has determined that there is
meaning that a market existed pre- Authorized OTC tests self-administered adequate laboratory capacity to enable
COVID–19, and manufacturers were by employees and proctored by the compliance with the ETS testing option.
able to adapt to fluctuations in demand employer do not require a CLIA
certificate of waiver. f. Access to Testing in Underserved
spurred by the pandemic.
There are multiple companies with The Association of Public Health Communities
facilities in the United States that Laboratories (APHL) has conducted Individuals in underserved
produce RNA extraction kits for the weekly surveys of its membership to communities (including Black, Latino,
domestic market that have been monitor their current and projected and Indigenous and Native American
awarded federal grants to increase the capability and capacity to test for persons, Asian Americans and Pacific
supply of COVID–19 test kits and COVID–19. Data from this survey is Islanders and other persons of color;
reagent supplies. For example, in used to inform HHS, FEMA, CDC, and members of religious minorities;
December 2020, the DOD and HHS other federal partners to support public lesbian, gay, bisexual, transgender, and
identified several key reagents with the health laboratory supply and reagent queer persons; persons with disabilities;
potential for supply chain bottlenecks needs. OSHA reviewed the weekly persons who live in rural areas; and
and awarded a $4.8 million Indefinite COVID–19 survey results through the persons otherwise adversely affected by
Delivery/Indefinite Quantity contract to APHL COVID–19 Lab Testing Capacity persistent poverty or inequality) are
Anatrace Products, LLC to support and Capability Data Dashboard. The disproportionately burdened by the
increased production of key reagents for data comes from voluntary participation COVID–19 pandemic as many
sample processing; Polyadenylic Acid in the weekly surveys collected from individuals in these communities are
(Poly A), Guanidinium Thiocyanate approximately 100 state, local and essential workers who cannot work from
(GTC), and Proteinase K (Pro K) to territorial public health laboratories home, increasing their risk of being
process samples (DOD, December 21, (PHLs) and reported to the CDC. The exposed to the virus. Access to COVID–
2020). Additionally, QIAGEN (based in APHL weekly survey data supports 19 testing in these communities has
Germany with U.S. manufacturing in OSHA’s feasibility determination and been identified as contributing factor to
Germantown, Maryland) produces demonstrates that COVID–19 testing COVID–19 related health disparities in
extraction kits for authorized COVID–19 demand will be met. For example, from these communities. For example, the
tests and has responded to the August 15, 2021 to September 12, 2021, NSC June 2021 survey found that the
pandemic by scaling their production to the APHL weekly survey data found that most common barrier to testing for rural
around the clock production to 96–100% of PHLs are meeting their employers and workers is access to
strengthen testing kit capacity (Qiagen, current testing demand since the Delta vaccination and testing sites (NSC,
October 2, 2021). On August 23, 2021, Variant surge began (APHL, September September 2021).
DOD, on behalf of and in coordination 27, 2021). Several federal efforts have recently
with HHS, awarded a $600,000 contract Laboratory capacity for processing been implemented to strengthen testing
to QIAGEN to expand manufacturing and confirmation of at-home COVID–19 capabilities in underserved
capacity of enzymatic reagents and rapid tests provided by manufacturer communities. The NIH has invested
reagent kits used in COVID–19 retailers such as Walmart has also heavily to improve COVID–19 testing in
molecular diagnostic tests, thereby increased. Laboratory and diagnostic underserved communities throughout
allowing QIAGEN to increase its service providers have implemented the COVID–19 pandemic. On September
monthly production of reagent kits by parallel strategies to strengthen 30, 2020, the NIH received nearly $234
7,000 and enzymes by 5,100 milligrams laboratory capacity for confirmation of million to improve COVID–19 testing
by the end of February 2022 to support at-home COVID–19 rapid tests available for underserved and vulnerable
domestic laboratory testing for COVID– on the market for employers and populations that have been
19 (DOD, August 23, 2021). employees to utilize. For example, disproportionately affected by this
Additionally, manufacturers of raw Quest Diagnostics, which is the pandemic and launched the RADx
materials and solvents for COVID–19 laboratory processing the samples and Underserved Populations (RADx-UP)
test kits have implemented strategies to delivering results to those tested at program (NIH, September 30, 2020).
strengthen their portions of the COVID– Walmart’s drive-through and curbside The RADx-UP program has primary
19 test supply chain. Millipore Sigma, a testing sites, has scaled up laboratory components supported by these NIH
large producer of solvents and raw testing capacity and rapid antigen test grants to increase availability,
materials for tests, has created a global inventory should demand increase accessibility, and acceptance of testing
task force to actively evaluate the (Walmart, July 9, 2021). Quest among underserved and vulnerable
overall supply chain of products and Diagnostics has added COVID–19 populations. The RADx-UP program
key raw material suppliers to mitigate testing platforms in laboratories in also provides overarching support and
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61456 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
guidance on administrative operations employers in these communities host the aforementioned OSHA standards,
and logistics, facilitating effective use of on-site vaccinations to increase worker and OSHA therefore concludes that
COVID–19 testing technologies, access. Applications for mobile compliance is feasible. Employers
supporting community and health vaccination are available on most local subject to the ETS will be able to
system engagement, and providing and state health department websites comply with the provisions in the ETS
overall infrastructure for data collection, (NSC, September 2021; ASU WEF, using straightforward recordkeeping
integration, and sharing from a September 2021). systems that are already widely used by
coordination and data collection center CVS has collaborated with several large employers as part of their usual
(NIH, September 30, 2021). Through the organizations, including the National and customary business practices.
RADx-UP program, the NIH has Medical Association, to increase access OSHA concludes that it is feasible for
continued to support the needs of to testing in underserved communities such employers to comply with the
underserved populations and is and has developed mobile solutions that requirements in the ETS for maintaining
currently funding 70 community-based allow health care professionals to bring records related to COVID–19
projects across the country (NIH, testing capabilities to businesses in vaccination status and COVID–19 test
September 30, 2021). these communities as they re-open (CVS results.
The CDC has also focused its efforts Health, September 2021). Walgreens has
to improve COVID–19 testing in implemented efforts to increase access VI. Other Provisions
underserved communities throughout in underserved communities such as There are no technological feasibility
the COVID–19 pandemic. For example, rural and/or lower socioeconomic barriers related to compliance with
on September 20, 2021, Maine Health, communities as well, with now more other requirements in the ETS (e.g., face
the largest health care organization in than half of Walgreens testing sites coverings, employee notification). As
Maine and also serving northern New currently located in areas the CDC has explained above, many of the employer
Hampshire, was awarded nearly $1 identified as socially vulnerable and plans and best practice documents
million for COVID–19 testing in higher underserved (Walgreens, October 2021). reviewed by OSHA indicate that
risk communities (Maine Health, Because of these investments, OSHA employers have implemented the
September 20, 2021). In March 2021, the concludes that employers and their measures in these provisions across
CDC implemented a plan to invest $2.25 employees in underserved communities, industry sectors. OSHA highlights two
billion over two years to address including those in rural areas, will have of the ETS’s other requirements below,
COVID–19 related health disparities and sufficient access to COVID–19 tests and which are explored in more depth in
advance health equity among will be able to comply with the ETS’s other sections of this preamble.
populations that are at high-risk and testing requirements for employees who
underserved, including racial and are not fully vaccinated. • Face Coverings. Paragraph (i) of the
ethnic minority groups and people ETS requires the employer to ensure
V. Management of Confidential Medical that all employees who are not fully
living in rural areas. Since that time, the
Records, Including Employee COVID–19 vaccinated wear a face covering when
CDC has awarded grants to public
Vaccination and Testing Records indoors and when occupying a vehicle
health departments to improve testing
capabilities; improve data collection The ETS requires employers to with another person for work purposes,
and reporting; and build, leverage, and maintain a record of each employee’s except: (i) When an employee is alone
expand infrastructure support for testing vaccination status. Employers must also in a room with floor to ceiling walls and
(CDC, March 17, 2021). On September maintain a record of each test result a closed door; (ii) for a limited time
30, 2021, the CDC awarded an $8.1 provided by each employee. These while the employee is eating or drinking
million grant to the Arizona Center for records must be maintained as at the workplace or for identification
Rural Health (ACRH) to address COVID– confidential medical records and must purposes in compliance with safety and
19 disparities across Arizona by not be disclosed except as required or security requirements; (iii) when
improving the delivery of COVID–19 authorized by this ETS or other federal employees are wearing respirators or
testing to rural and underserved law. The records are not subject to the face masks; or (iv) where the employer
communities (ASU CRH, September 30, retention requirements of 29 CFR can show that the use of face coverings
2021). A number of other federal and 1910.1020(d)(1)(i) but must be is infeasible or creates a greater hazard.
state government agencies have been maintained and preserved while the The definition of face covering allows
expanding support for COVID–19 ETS is in effect. various different types of masks,
testing in underserved communities as Other OSHA rules have a similar including clear face coverings or cloth
well. On June 11, 2021, HHS through requirement to maintain employee face coverings with a clear plastic panel
the Health Resources and Services medical records, which could include which may be used to facilitate
Administration (HRSA) provided $424.7 vaccination records. See, e.g., communication with people who are
million in American Rescue Plan Bloodborne Pathogens (29 CFR deaf or hard-of-hearing or others who
funding to over 4,200 Rural Health 1910.1030), Respiratory Protection (29 need to see a speaker’s mouth or facial
Clinics (RHCs) for COVID–19 testing CFR 1910.134), Respirable Crystalline expressions to understand speech or
(HHS, June 11, 2021). Silica (29 CFR 1910.1053), Beryllium sign language respectively. The types of
Private industry has also mobilized (29 CFR 1910.1024), Lead (29 CFR face coverings permitted under this ETS
considerably to increase access and 1910.1025), and OSHA’s requirements are widely used and readily available.
testing capacity in rural and other for employee access to medical and The results of the ASU WEF June 2021
underserved communities. The NSC exposure records (29 CFR 1910.1020). survey found that 30% of employers
June 2021 survey found that a common OSHA is not aware of any potential required face coverings for unvaccinated
barrier to employers and employees in technological feasibility issues related to employees, which demonstrates that
rural and other underserved recordkeeping. this provision of the ETS is currently
communities is transportation and The requirement under this ETS to being implemented by a substantial
access to vaccination and testing sites maintain records of employees’ COVID– number of employers and is ‘‘capable of
(NSC, September 2021). In its final 19 vaccination status and COVID–19 being done.’’ (ASU WEF, September
report, the NSC recommended test results is similar to requirements in 2021). OSHA identifies no technological
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61457
feasibility issues with this provision of largely mirror the requirements for the media/releases/2021/p0317-COVID-19-
the ETS. collection and maintenance of similar Health-Disparities.html. (CDC, March 17,
• Notification. Paragraph (h) of the employee medical records in OSHA’s 2021)
ETS contains COVID–19 notification Centers for Disease Control and Prevention
Bloodborne Pathogens standard (29 CFR
(CDC). (2021, July 8). Guidance for
requirements for both the employer and 1910.1030) and the Respiratory SARS-CoV–2 Point-of-Care and Rapid
the employee. Under this provision, the Protection standard (29 CFR 1910.134). Testing. https://www.cdc.gov/
employer must require each employee The ETS provides a flexible compliance coronavirus/2019-ncov/lab/point-of-
to promptly notify the employer if they option for employers to tailor their care-testing.html. (CDC, July 8, 2021)
receive a positive COVID–19 test or are procedures and practices to the needs of Centers for Disease Control and Prevention
diagnosed with COVID–19 by a licensed their workplace. OSHA finds that (CDC). (2021, September 9). Interim
healthcare provider and must employers in typical firms in all Guidance for Antigen Testing for SARS-
immediately remove any employee from CoV–2. https://www.cdc.gov/
industry sectors can comply with the
the workplace who receives a positive coronavirus/2019-ncov/lab/resources/
requirements of the ETS, and antigen-tests-guidelines.html. (CDC,
COVID–19 test or is diagnosed with compliance with the ETS is therefore September 9, 2021)
COVID–19 by a licensed healthcare technologically feasible. Colorado Department of Public Health and
provider. OSHA identifies no Environment (CDPHE). (2021, September
technological feasibility issues in References 17). Vaccine laws and regulations.
connection with the ETS’s notification Advanced Medical Technology Association https://covid19.colorado.gov/vaccine-
requirements. It is the employer’s (AdvaMed). (2021, September 10). laws-regulations. (CDPHE, September 17,
responsibility to ensure that appropriate ADVAMED COVID–19 Diagnostic 2021)
instructions and procedures are in place Supply Registry. https:// Congressional Research Service (CRS). (2021,
so that designated representatives of the www.advamed.org/wp-content/uploads/ February 25). COVID–19 Testing Supply
2021/09/AdvaMed-COVID-Testing- Chain. https://crsreports.congress.gov/
employer (e.g., managers, supervisors)
Supply-Registry-weekly-report- product/pdf/IF/IF11774. (CRS, February
and employees conform to the rule’s 091021.pdf (AdvaMed, September 10, 25, 2021)
requirements. 2021) CVS Health. (2021, August 23). CVS Health
VII. Conclusion Amazon.com (Amazon). (2021, October 12). will require COVID–19 vaccinations for
Amazon.com product search results: clinical and corporate employees.
OSHA has determined that complying FDA EUA covid-19 tests. https:// https://cvshealth.com/news-and-
with this ETS is technologically feasible www.amazon.com/ insights/statements/cvs-health-will-
for typical firms covered by this s?k=FDA+EUA+covid-19+tests&ref=nb_ require-covid-19-vaccinations-for-
standard, at least most of the time (see sb_noss_2. (Amazon, October 12, 2021) clinical-and-corporate-employees. (CVS
Public Citizen v. OSHA, 557 F.3d 165 Arizona State University College of Health Health, August 23, 2021)
(3d Cir. 2009); Lead I, 647 F.2d at 1272; Solutions (ASU). (2021, October 5). CVS Health. (2021, September). COVID–19:
Lead II, 939 F.2d at 990). OSHA COVID–19 Diagnostic Commons. https:// Testing information. https://
chs.asu.edu/diagnostics-commons. cvshealth.com/covid-19/testing-
reviewed extensive evidence across
(ASU, October 5, 2021) information. (CVS Health, September
industries and did not identify any Arizona State University (ASU) and the 2021)
industry-specific compliance barriers. World Economic Forum (WEF). (2021, Delta Airlines. (2021, August 25). Bastian
Evidence in the record that shows that September). How work has changed: The memo to employees outlines COVID
the written workplace COVID–19 Lasting Impact of COVID–19 on the vaccine updates. https://news.delta.com/
vaccination policy requiring each Workplace. https://issuu.com/ bastian-memo-employees-outlines-covid-
employee to be fully vaccinated against asuhealthsolutions/docs/asu_workplace_ vaccine-updates. (Delta, August 25,
COVID–19 unless they establish and commons_sept2021_ 2021)
implement a written policy that permits singles?fr=sNjBiNDE5NTg1NjM. (ASU Fifty/50 Group. (2021, May 18). Employee
an employee to choose to be tested for WEF, September 2021) Vaccination Requirement Policy. https://
Association of Public Health Laboratories www.thefifty50group.com/covidvaccines.
COVID–19 at least every seven days and
(APHL). (2021, September 27). Lab (Fifty/50 Group, May 18, 2021)
wear a face covering is feasible. In fact, Testing Capacity and Capability Data Food and Drug Administration (FDA). (2020,
such policies have already been Dashboard. https://www.aphl.org/ May 9). Coronavirus (COVID–19)
implemented by hundreds of large programs/preparedness/Crisis- Update: FDA Authorizes First Antigen
companies across industry sectors. Management/COVID-19-Response/ Test to Help in the Rapid Detection of
OSHA has also determined that there Pages/COVID-19-Dashboard.aspx. the Virus that Causes COVID–19 in
are sufficient COVID–19 tests available (APHL, September 27, 2021) Patients. https://www.fda.gov/news-
and adequate laboratory capacity to Becker’s Hospital Review. (2021, October 11). events/press-announcements/
meet the anticipated increased testing Hospitals, health systems mandating coronavirus-covid-19-update-fda-
demand related to compliance with the vaccines for workers. https:// authorizes-first-antigen-test-help-rapid-
www.beckershospitalreview.com/ detection-virus-causes. (FDA, May 9,
ETS testing option. workforce/hospitals-health-systems- 2020)
Additionally, the ETS’s requirements mandating-vaccines-for- Food and Drug Administration (FDA). (2021,
to determine employee vaccination workersjune17.html. (Becker’s Hospital March 31). Emergency Use Authorization
status, support employee vaccination by Review, October 11, 2021) QuickVue At-Home OTC COVID–19
providing time off for vaccination and Capital One. (2021, August 11). Capital Test. https://www.fda.gov/media/
time off for recovery, and maintain One Announces Modifications to 147247/download. (FDA, March 31,
records of employee COVID–19 Workplace Return. https:// 2021)
vaccination status and COVID–19 test www.capitalone.com/about/newsroom/ Food and Drug Administration (FDA). (2021,
results are also technologically feasible. return-to-office-update/. (Capital One, June 11). Emergency Use Authorization
August 11, 2021) Sofia SARS Antigen FIA OTC COVID–19
As discussed above, that many
Centers for Disease Control and Prevention Test. https://www.fda.gov/media/
employers and organizations have (CDC). (2021, March 17). CDC 137886/download. (FDA, June 11, 2021)
already implemented such requirements Announces $2.25 Billion to Address Food and Drug Administration (FDA). (2021,
demonstrates that they are ‘‘capable of COVID–19 Health Disparities in September 10). COVID–19 Tests and
being done.’’ Moreover, the Communities that are at High-Risk and Collection Kits Authorized by the FDA:
recordkeeping requirements in this ETS Underserved. https://www.cdc.gov/ Infographic. https://www.fda.gov/
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medical-devices/coronavirus-covid-19- RADxSM Tech: A New Paradigm for advances six new COVID–19 testing
and-medical-devices/covid-19-tests-and- MedTech Development Overview of This technologies. https://www.nih.gov/news-
collection-kits-authorized-fda- Special Section. https:// events/news-releases/nih-radx-initiative-
infographic. (FDA, September 10, 2021) ieeexplore.ieee.org/document/9418526. advances-six-new-covid-19-testing-
Food and Drug Administration (FDA). (2021, (IEEE, April 28, 2021) technologies. (NIH, October 6, 2020)
September 22). Coronavirus Disease 2019 International Union of Painters and Allied National Institutes of Health (NIH). (2020,
Testing Basics. https://www.fda.gov/ Trades (IUPAT). (2021, May 10). IUPAT September 30). NIH to assess and expand
consumers/consumer-updates/ Supports Vaccine Mandates. https:// COVID–19 testing for underserved
coronavirus-disease-2019-testing-basics. www.iupat.org/press-room/vaccine- communities. https://www.nih.gov/news-
(FDA, September 22, 2021) policy/. (IUPAT, May 10, 2021) events/news-releases/nih-assess-expand-
Food and Drug Administration (FDA). (2021, Johns Hopkins University. (2021, October 8). covid-19-testing-underserved-
October 1). Coronavirus (COVID–19) Coronavirus Resource Center: Testing communities. (NIH, September 30, 2020)
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www.fda.gov/news-events/press- individual-states. (JHU, October 8, 2021) April 29). NIH mobilizes national
announcements/coronavirus-covid-19- Kaiser Permanente. (2021, August 2). innovation initiative for COVID–19
update-october-1-2021. (FDA, October 1, Protecting health and safety through diagnostics. https://www.nih.gov/news-
2021) vaccination. https:// events/news-releases/nih-mobilizes-
Food and Drug Administration (FDA). (2021, about.kaiserpermanente.org/our-story/ national-innovation-initiative-covid-19-
October 4). Coronavirus (COVID–19) news/announcements/protecting-health- diagnostics. (NIH, April 29, 2020)
Update: FDA Authorizes Additional OTC and-safety-through-vaccination. (Kaiser National Safety Council (NSC). (2021, May
Home Test to Increase Access to Rapid Permanente, August 2, 2021) 17). SAFER: Safe Actions For Employee
Testing for Consumers. https:// MaineHealth. (2021, September 20). Returns. https://www.nsc.org/getmedia/
www.fda.gov/news-events/press- MaineHealth awarded nearly $1M by f5dfd05d-83bf-4753-8903-
announcements/coronavirus-covid-19- National Institutes of Health to study 538a24157725/safer-framework-
update-fda-authorizes-additional-otc- COVID–19 testing in higher risk summary.pdf. (NSC, May 17, 2021)
home-test-increase-access-rapid-testing. communities. https:// National Safety Council (NSC). (2021,
(FDA, October 4, 2021) www.mainehealth.org/News/2021/09/ September). SAFER Report: A Year in
Food and Drug Administration (FDA). MaineHealth-awarded-nearly-1M-by- Review, and What’s Next. https://
(2021a, October 14). In Vitro Diagnostics NIH-to-study-COVID19-testing. (Maine www.nsc.org/workplace/safety-topics/
EUAs—Antigen Diagnostic Tests for Health, September 20, 2021) safer/state-of-the-response-state-actions-
SARS-CoV–2. https://www.fda.gov/ Mayo Clinic Laboratories. (2020, June 30). to-address-the. (NSC, September 2021)
medical-devices/coronavirus-disease- Mayo Clinic experts to help guide Delta Puritan Products. (2020, April 20). Puritan
2019-covid-19-emergency-use-
Air Lines COVID–19 safety measures. Blog: Puritan at the Epicenter of COVID–
authorizations-medical-devices/in-vitro-
https://newsnetwork.mayoclinic.org/ 19 Testing. https://
diagnostics-euas-antigen-diagnostic-
discussion/delta-engages-mayo-clinic- blog.puritanmedproducts.com/puritan-
tests-sars-cov-2. (FDA, October 14,
experts-to-advise-on-making-travel-even- at-epicenter-of-covid-19-testing. (Puritan
2021a)
safer/. (Mayo Clinic Laboratories, June Products, April 20, 2020)
Food and Drug Administration (FDA).
30, 2020) Qiagen. (2021, October 2). COVID–19 Latest
(2021b, October 14). In Vitro Diagnostics
Microbrush. (2020, July 1). Microbrush News. https://www.qiagen.com/us/
EUAs—Molecular Diagnostic Tests for
SARS-CoV–2. https://www.fda.gov/ Introduces New Nasopharyngeal Test customer-stories/latest-news-on-the-
medical-devices/coronavirus-disease- Swabs. https://www.prnewswire.com/ fight-against-coronavirus. (Qiagen,
2019-covid-19-emergency-use- news-releases/microbrush-introduces- October 2, 2021)
authorizations-medical-devices/in-vitro- new-nasopharyngeal-test-swabs- Quest Diagnostics. (2021, September 28).
diagnostics-euas-molecular-diagnostic- 301087276.html. (Microbrush, July 1, Quest Diagnostics Media Statement
tests-sars-cov-2. (FDA, October 14, 2020) about COVID–19 Testing. https://
2021b) Millipore Sigma. (2021, October). newsroom.questdiagnostics.com/
Fulton County, Georgia. (2021, September 3). Coronavirus COVID–19 (SARS-CoV–2) COVIDTestingUpdates. (Quest
Fulton Commissioners Approve Detection, Characterization, Vaccine and Diagnostics, September 28, 2021)
Employee Vaccine Protocols. https:// Therapy Production. https:// Quidel Corporation. (2020, July 31). Press
www.fultoncountyga.gov/news/2021/09/ www.sigmaaldrich.com/US/en/life- release, Quidel Corp. https://
03/fulton-commissioners-approve- science/covid. (Millipore Sigma, October ir.quidel.com/news/news-release-details/
employee-vaccine-protocols. (Fulton 2021) 2020/Quidel-Receives-Preliminary-
County Government, September 3, 2021) National Academy for State Health Policy Contract-Leading-to-Definitive-
Genesis Health Care. (2021, September 29). (NASHP). (2021, October 1). State Agreement-for-71-Million-Under-NIHs-
Coronavirus Updates. https:// Efforts to Ban or Enforce COVID–19 RADx-ATP-Program-to-Accelerate-the-
www.genesishcc.com/coronavirus- Vaccine Mandates and Passports. Expansion-of-Its-Manufacturing-
updates. (Genesis Health Care, https://www.nashp.org/state-lawmakers- Capacity-for-Sofia-SARS-CoV-2-Antigen-
September 29, 2021) submit-bills-to-ban-employer-vaccine- Detection-Test-for-Rapid-Diagnosis-of-
Health Action Alliance (HAA). (2021, mandates/. (NASHP, October 1, 2021) COVID-19/default.aspx. (Quidel Corp.,
October 10). COVID–19 Vaccines: National Institutes of Health (NIH) National July 31, 2020)
Employers & Requirements. A list of Institute of Biomedical Imaging and RiteAid. (2021, October). Free* COVID–19
companies requiring vaccinations for all Bioengineering (NIBIB). (2021, Testing. https://www.riteaid.com/
or part of their workforce or customers. September 28). RADx Tech/ATP pharmacy/services/covid-19-testing.
https://www.healthaction.org/resources/ Dashboard. https://www.nibib.nih.gov/ (RiteAid, October 2021)
vaccines/covid-19-vaccines-employer- covid-19/radx-tech-program/radx-tech- Sanford Health. (2021, July 22). Sanford
requirements-health-action-alliance. dashboard. (NIBIB, September 28, 2021) Health to require COVID–19 vaccine for
(HAA, October 10, 2021) National Institutes of Health (NIH) National employees. https://
Health Action Alliance (HAA) and the Institute of Biomedical Imaging and news.sanfordhealth.org/news-release/
National Safety Council (NSC). (2021, Bioengineering (NIBIB). (2021, October sanford-to-require-covid-19-vaccine-for-
September 17). COVID–19 Employer 14). RADxSM Tech and ATP Programs: employees/. (Sanford Health, July 22,
Policies: A Decision Tool for Business Phase 2 Awards. https:// 2021)
Leaders. https://www.healthaction.org/ www.nibib.nih.gov/covid-19/radx-tech- Trinity Health. (2021, July 8). Trinity Health
reopening-questions#Q. (HAA and NSC, program/radx-tech-phase2-awards. Announces COVID–19 Vaccine
September 17, 2021) (NBIB, October14, 2021) Requirement for All Colleagues. https://
Institutes of Electrical and Electronics National Institutes of Health (NIH). (2020, www.trinity-health.org/news/trinity-
Engineers. (IEEE). (2021, April 28). October 6). NIH RADx initiative health-announces-covid-19-vaccine-
App. 58
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61459
requirement-for-all-colleagues. (Trinity testing?ban=covid_hp_cause2. focused only on costs to employers
Health, July 8, 2021) (Walgreens, October 2021) when evaluating economic feasibility. In
Tyson Foods. (2021, August 3) Tyson Foods Walgreens. (2021, October 8). COVID–19 a regulatory impact analysis, the costs to
to Require COVID–19 Vaccinations for FAQs. https://news.walgreens.com/our-
stories/covid-19-stories/covid-19-
all parties (e.g., employers, employees,
its U.S. Workforce. https://
www.tysonfoods.com/news/news- faq.htm#testinghome. (Walgreens, and governments) are included. While
releases/2021/8/tyson-foods-require- October 8, 2021) this is not the case for an economic
covid-19-vaccinations-its-us-workforce. Walmart. (2021, July 9). Supporting COVID– feasibility analysis, it does not
(Tyson Foods, August 3, 2021) 19 Testing. https:// necessarily mean that the ETS imposes
University of Arizona Center for Rural Health corporate.walmart.com/covid19testing. no costs or burdens on parties other
(ASU CRH). (2021, September 30). (Walmart, July 9, 2021) than employers. For example, the rule
ADHS–CDC COVID Disparities Initiative. Washington Post. (2021, October 6). White imposes certain costs on employees who
https://crh.arizona.edu/programs/covid- House announces $1 billion purchase of
rapid, at-home coronavirus tests. https://
choose not to become vaccinated (e.g.,
disparities-initiative. (ASU CRH,
September 30, 2021) www.washingtonpost.com/health/2021/ for face coverings and testing. While
U.S. Department of Defense (DOD). (2021, 10/06/biden-rapid-at-home-covid-tests/. these costs are not relevant for the
March 29) DOD Awards $146.77 Million (Washington Post, October 6, 2021) purpose of establishing economic
Contract to Puritan Medical Products to Willis Towers Watson. (2021, June 23) feasibility, these costs would be
Increase Domestic Production Capacity COVID–19 Vaccination and Reopening attributable to the ETS in a regulatory
of Foam Tip Swabs. https:// the Workplace Survey press release. impact analysis. In addition, these costs
www.defense.gov/News/Releases/ https://www.willistowerswatson.com/en- are not mandatory because any
Release/Article/2554073/dod-awards- US/News/2021/09/workplace-vaccine-
mandates-expected-to-accelerate-wtw-
employee who does not wish to pay
14677-million-contract-to-puritan-
medical-products-to-increase-domes/. survey-finds. (Willis Towers Watson, them may choose to become vaccinated
(DOD, March 29, 2021) June 23, 2021) or leave employment (see discussion
U.S. Department of Defense (DOD). (2021, Willis Towers Watson. (2021, September 1) below on turnover), after which the
July 31). DOD Awards $51.15 Million Workplace vaccine mandates expected to costs would not be incurred. Some
Undefinitized Contract Action to Puritan accelerate, Willis Towers Watson survey employees may also be entitled to a
Medical Products Company LLC to finds. https:// reasonable accommodation that may
Increase Domestic Production Capacity www.willistowerswatson.com/en-US/ avoid additional cost (e.g., telework).
of Flock Tip Testing Swabs. https:// News/2021/09/workplace-vaccine-
www.defense.gov/News/Releases/ mandates-expected-to-accelerate-wtw- ‘‘[T]he Supreme Court has
Release/Article/2295387/dod-awards- survey-finds. (Willis Towers Watson, conclusively ruled that economic
5115-million-undefinitized-contract- September 1, 2021) feasibility [under the OSH Act] does not
action-to-puritan-medical-produc/. involve a cost-benefit analysis.’’ Pub.
B. Economic Analysis
(DOD, July 31, 2021) Citizen Health Research Grp. v. U.S.
U.S. Department of Defense (DOD). (2021, I. Introduction Dept. of Labor, 557 F.3d 165, 177 (3d
August 23). DOD Awards $0.6 Million Cir. 2009); see also Asbestos Info. Ass’n,
Contract to QIAGEN to Increase This section presents OSHA’s
estimates of the costs and impacts, 727 F.2d at 424 n.18 (noting that formal
Domestic Production Capacity of
anticipated to result from the COVID–19 cost benefit is not required for an ETS,
COVID–19 Diagnostic Test Kits and
Reagents. https://www.defense.gov/ Vaccination and Testing ETS, 29 CFR and indeed may be impossible in an
News/Releases/Release/Article/2742967/ 1910.501. The purpose of this ETS is to emergency). The OSH Act ‘‘place[s] the
dod-awards-06-million-contract-to- address the grave danger of COVID–19 ‘benefit’ of worker health above all other
qiagen-to-increase-domestic-production- in the workplace by promoting considerations save those making
capaci/. (DOD, August 23, 2021) vaccination, while allowing an attainment of this ‘benefit’
U.S. Department of Defense (DOD). (2021, unachievable.’’ Cotton Dust, 452 U.S. at
alternative for face covering and testing
December 21). DOD Awards $4.8 Million 509. Therefore, ‘‘[a]ny standard based
Indefinite Delivery/Indefinite Quantity requirements, and also to remove
COVID–19 positive workers from the on a balancing of costs and benefits by
to a Calibre Scientific Subsidiary, the Secretary that strikes a different
Anatrace, to Increase Domestic workplace regardless of vaccination
Production Capacity of COVID–19 status. The estimated costs are based on balance than that struck by Congress
Testing Reagents. https:// employers achieving full compliance would be inconsistent with the
www.defense.gov/News/Releases/ with the requirements of the ETS. They command set forth in’’ the statute. Id.
Release/Article/2454163/dod-awards-48- do not include prior costs associated While this case law arose with respect
million-indefinite-deliveryindefinite- with firms whose current practices are to health standards issued under section
quantity-to-a-calibre-scien/. (DOD, 6(b)(5) of the Act, which specifically
already in compliance with the ETS
December 21, 2020) require feasibility, OSHA finds the same
U.S. Department of Health and Human requirements. The purpose of this
analysis is to: concerns applicable to emergency
Services. (HHS). (2021, June 11). HHS temporary standards issued under
Provides $424.7 Million to Rural Health • Identify the entities/establishments
Clinics for COVID–19 Testing and and industries affected by the ETS; section 6(c) of the Act. An ETS ‘‘serve[s]
Mitigation in Rural Communities. • Estimate and evaluate the costs and as a proposed rule’’ for a section 6(b)(5)
https://www.hhs.gov/about/news/2021/ economic impacts that regulated standard, and therefore the same limits
06/11/hhs-provides-424-million-to-rural- entities/establishments will incur to on any requirement for cost-benefit
health-clinics-for-covid-19-testing.html. achieve compliance with the ETS; and analysis should apply. Indeed, OSHA
(HHS, June 11, 2021) • Evaluate the economic feasibility of has also rejected the use of formal cost
U.S. Department of Health and Human the rule for affected industries. benefit analysis for safety standards,
Services (HHS). (2021, August 17). In this analysis, OSHA is fulfilling the which are not governed by section
Community based testing sites. https:// 6(b)(5). See 58 FR 16,612, 16,622–23
requirement under the OSH Act to show
www.hhs.gov/coronavirus/community-
based-testing-sites/index.html. (HHS, the economic feasibility of this ETS. (Mar. 30, 1993) (‘‘in OSHA’s judgment,
August 17, 2021) This analysis is different from the cost its statutory mandate to achieve safe and
Walgreens. (2021, October). Free Drive-Thru portion of a regulatory impact analysis healthful workplaces for the nation’s
COVID–19 Testing for Ages 3+. https:// prepared in accordance with Executive employees limits the role monetization
www.walgreens.com/findcare/covid19/ Order 12866 in that the agency is of benefits and analysis of extra-
App. 59
61460 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
workplace effects can play in setting F.3d at 296 (quoting Lead II, 939 F.2d However, the requirements of this ETS
safety standards.’’).22 A standard must at 1006). Rather, OSHA’s estimates must do not apply to: (1) Workplaces covered
be economically feasible in order to be represent ‘‘a reasonable assessment of under the Safer Federal Workforce Task
‘‘reasonably necessary and appropriate’’ the likely range of costs of its standard, Force COVID–19 Workplace Safety:
under section 3(8) and, by inference, and the likely effects of those costs on Guidance for Federal Contractors and
‘‘necessary’’ under section 6(c)(1)(B) of the industry.’’ Lead I, 647 F.2d at 1266. Subcontractors (Contractor Guidance);
the OSH Act. Cf. Am. Textile Mfrs. Inst., The ‘‘mere ‘possibility of drawing two or (2) settings where any employee
Inc. v. Donovan, 452 U.S. 490, 513 n.31 inconsistent conclusions from the provides healthcare services or
(1981) (noting ‘‘any standard that was evidence,’ or deriving two divergent healthcare support services when
not economically . . . feasible would a cost models from the data ‘does not subject to the requirements of 29 CFR
fortiori not be ‘reasonably necessary or prevent [the] agency’s finding from 1910.502 (i.e., the Healthcare ETS).
appropriate’ ’’ as required by the OSH being supported by substantial Furthermore, the requirements of this
Act’s definition of ‘‘occupational safety evidence.’ ’’ Silica, 878 F.3d at 296 ETS do not apply to the employees of
and health standard’’ in section 3(8)); (quoting Cotton Dust, 452 U.S. at 523). covered employers: (1) Who do not
see also Florida Peach Growers, 489 Executive Orders 12866 and 13563 report to a workplace where other
F.2d at 130 (recognizing that the direct agencies to assess the costs and individuals, such as coworkers or
promulgation of any standard, including benefits of the intended regulation and, customers, are present; or (2) while
an ETS, must account for its economic if regulation is necessary, to select working from home; or (3) who work
effect). A standard is economically regulatory approaches that maximize exclusively outdoors. Based on this
feasible when industries can absorb or net benefits (including potential scope, employers in nearly every sector
pass on the costs of compliance without economic, environmental, and public are expected to be covered by this ETS.
threatening industry’s long-term health and safety effects; distributive OSHA’s assumptions may result in an
profitability or competitive structure, impacts; and equity). Executive Order overestimate of the number of
Cotton Dust, 452 U.S. at 530 n.55, or 13563 emphasized the importance of employees affected by the ETS. First,
‘‘threaten[ing] massive dislocation to, or quantifying both costs and benefits, of OSHA is not estimating the number and
imperil[ing] the existence of, the reducing costs, of harmonizing rules, type of workplaces covered by the Safer
industry.’’ United Steelworkers of Am. and of promoting flexibility. Because of Federal Workforce Task Force COVID–
v. Marshall, 647 F.2d 1189, 1272 (D.C. the continued impact of the pandemic 19 Workplace Safety: Guidance for
Cir. 1981) (Lead I). Given that section on occupational safety and health, Federal Contractors and Subcontractors
6(c) is aimed at enabling OSHA to OSHA has prepared this ETS and the or removing them from the profile of
protect workers in emergency situations, accompanying economic analysis on an employers affected by this ETS. OSHA
the agency is not required to make the extremely condensed timeline. Thus, in assumes for the purpose of this analysis
showing with the same rigor as in light of the Secretary’s conclusion that that employers covered under the
ordinary section 6(b) rulemaking. the COVID–19 pandemic constitutes an Contractor Guidance will also have
Asbestos Info. Ass’n/N. Am. v. OSHA, emergency situation, the Secretary has contracts to perform work in workplaces
727 F.2d 415, 424 n.18 (5th Cir. 1984). notified OIRA that it is necessary for where they are not covered under that
In Asbestos Information Association, the OSHA to promulgate this regulation Guidance (i.e., where the employer
Fifth Circuit concluded that the costs of more quickly than normal review contracts with an entity other than the
federal government), and so those
compliance were not unreasonable to procedures allow, pursuant to E.O.
employers are included in the scope
address a grave danger where the costs 12866 Sec. 6 (a)(3)(D). OIRA has waived
here.
of the ETS did not exceed 7.2% of compliance with Sec. 6(a)(3)(B) and (C) Second, OSHA estimates that all
revenues in any affected industry. Id. at for this economically significant rule. employers in all private sector
424. industries are affected by this ETS to
II. COVID–19 ETS Industry Profile
The scope of judicial review of some extent. Although this ETS imposes
OSHA’s determinations regarding a. Introduction
no compliance burden on employers
feasibility (both technological and In this section, OSHA provides whose employees work remotely 100
economic) ‘‘is narrowly circumscribed.’’ estimates of the number of affected percent of the time, in OSHA’s analysis,
N. Am.’s Bldg. Trades Unions v. OSHA, entities, establishments, and employees no employers with 100 or more
878 F.3d 271, 296 (D.C. Cir. 2017) for the industries that have settings employees have all of their employees
(Silica). ‘‘OSHA is not required to prove covered by this ETS. The term ‘‘entity’’ working remotely 100 percent of the
economic feasibility with certainty, but describes a legal for-profit business, a time (i.e., at least some employees in
is required to use the best available non-profit organization, or a local each affected firm do not work
evidence and to support its conclusions governmental unit, whereas the term remotely). Moreover, OSHA’s analysis
with substantial evidence.’’ Amer. Iron ‘‘establishment’’ describes a particular does not take into account that some
& Steel Inst. v. OSHA, 939 F.2d 975, physical site of economic activity. Some employees may engage in part-time
980–81 (D.C. Cir. 1991) (Lead II); 29 entities own and operate more than one telework (i.e., it assumes that employees
U.S.C. 655(b)(5), (f). ‘‘Courts, establishment. either work remotely full-time or do not
[moreover], ‘cannot expect hard and Throughout this analysis, where work remotely at all). Finally, OSHA’s
precise estimates of costs.’ ’’ Silica, 878 estimates were derived from available analysis does not fully take into account
data those sources have been noted in the exemption for employees who do
22 To support its Asbestos ETS, OSHA conducted
the text. Estimates without sources not report to a workplace where other
an economic feasibility analysis on these terms. 48
FR 51086, 51136–38 (Nov. 4, 1983). In upholding noted in the text are based on agency individuals are present, meaning that
that analysis, the Fifth Circuit said that OSHA was expertise. this analysis may overestimate the
required to show that the balance of costs to number of employees affected by the
benefits was not unreasonable. Asbestos Info. Ass’n, b. Scope of the COVID–19 ETS
rule.
727 F.2d at 423. As explained above, OSHA does
not believe that is a correct statement of the
This ETS applies to all employers As stated, the requirements of this
economic feasibility test. However, even under that with a total of 100 or more employees ETS do not apply to the employees of
approach this ETS easily passes muster. at any time this ETS is in effect. covered employers who work
App. 60
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61461
exclusively outdoors. To determine the where workers are outdoors primarily outdoors are actually there
percentage of employees in occupations ‘‘constantly,’’ which OSHA interprets as exclusively. See Table IV.B.1 for the
for which the exception is relevant, the being nearly continuously outdoors. occupations, the ORS percentages, and
agency uses data from the BLS’s 2020 Because the majority of workers who final percentages for workers OSHA
Occupational Requirements Survey work outdoors ‘‘constantly’’ likely work estimates are exempt from the scope of
(ORS) (BLS, 2020). This survey looks at indoors at least some of the time, the this ETS based on the outdoor work
various aspects of job requirements. In agency judges that no more than 10 exemption.
particular, the survey lists occupations percent of the workers who are
OSHA’s estimate of employees who to the requirements of the Healthcare Healthcare ETS will be subject to the
work exclusively outdoors does not ETS). This potentially impacts two requirements of 29 CFR 1910.501 for
account for employers who only need to types of costs: Employer-based costs approximately 4 months (4 months of
make slight adjustments to their current (e.g., employer policy on vaccination) the 6 month estimated lifespan of 29
work practices to ensure that their and employee-based (periodic) costs CFR 1910.501). OSHA’s estimate of
employees qualify for the outdoor (e.g., recordkeeping). those employees exempted by the
exemption, such as by holding tool box Employer-Based Costs: For the Healthcare ETS was based on the
talks outdoors instead of in a traditional purpose of the economic analysis only, Industry Profile of employees in firms
indoor location. This may result in more OSHA treats the Healthcare ETS as with 100 employees or more covered by
employees falling within the exemption though it will no longer be in effect after the Healthcare ETS, as estimated in
than estimated by OSHA; therefore, December, 2021, because at that point Table VI.B.3 in the economic analysis
OSHA’s cost analysis likely the Healthcare ETS will have been in for that rulemaking (see 86 FR 32488).
overestimates costs. effect for the six months that OSHA had OSHA notes that some employees
The requirements of the ETS also do calculated costs for that ETS. Therefore, currently covered by the Healthcare ETS
not apply to settings where any OSHA estimates that some employers might also be currently covered by 29
employee provides healthcare services including those with 100 or more CFR 1910.501 (albeit at different times
or healthcare support services when employees subject to the 29 CFR or in different locations) because the
subject to the requirements of 29 CFR 1910.502 exemption, will need to take Healthcare ETS is settings-based. For
1910.502 (the Healthcare ETS). The employer-based costs because all these example, a pharmacist would normally
Healthcare ETS is a temporary standard employers will ultimately be subject to not need to comply with the
that may not remain in effect for the 29 CFR 1910.501 under this assumption. requirements of § 1910.502 when just
entire period that 29 CFR 1910.501 Employee-Based Costs: OSHA’s filling prescriptions in a retail pharmacy
remains in effect. This means that some estimates incorporate two assumptions store (see 29 CFR 1910.502(a)(2)(ii)), but
employers or employees covered by the for the purposes of this analysis only. would need to comply when
Healthcare ETS, those in firms that have First, for the purposes of assumptions administering vaccinations within an
100 or more employees, may ultimately for this analysis only, § 1910.501 will embedded clinic inside that retail
be covered by 29 CFR 1910.501 (because remain in effect for 6 months. Second, pharmacy. Thus, there are a number of
the exception in 29 CFR 1910.501 is many employers and employees variables that could impact the extent to
limited to when employers are subject currently covered only by the which the pharmacist’s employer might
App. 61
61462 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
incur any costs. However, even to the associated with any potential that were removed from the Industry
extent that such costs might occur (e.g., underestimate. Profile) before the end date of the
recordkeeping for testing if the In all respects (other than the 4⁄6 share Healthcare ETS based on the conclusion
pharmacist works for an employer of employee-based costs), OSHA is that 29 CFR 1910.501 will ultimately
covered by 29 CFR 1910.501 and is taking the same approach in the apply in full to them. Since these costs
unvaccinated), OSHA judges that they Industry Profile and Cost Estimates for still occur due to 29 CFR 1910.501,
would be de minimis for several employers and employees currently OSHA is appropriately including them
reasons. First, this pool of workers is covered by the Healthcare ETS as it does in this cost analysis.
likely to be very small, especially when for all other industries. These employers There are 9.9 million employees who
compared to the population of workers and employees are fully integrated into will newly be covered by 29 CFR
covered by the Healthcare ETS. Second, Table IV.B.5, below, which contains a 1910.501 starting in December whose
most employees subject to both summary of covered entities and employers will incur an additional $318
employees. Moreover, the same million in costs. These costs are
standards will have been fully
assumptions on outdoor work and other integrated into the agency’s main cost
vaccinated before OSHA takes costs for
scope exemptions that OSHA explains analysis, which is described later in this
these employees under 29 CFR 1910.501
earlier holds for these employers and economic analysis.
by operation of the CMS rule mandating employees. In addition, OSHA makes Only some state- and local-
vaccination or as a result of the the same downward adjustment in government entities are included in this
voluntary vaccination incentives telework for these employers and analysis. State- and local-government
promoted by OSHA’s Healthcare ETS employees in accordance with the entities are specifically excluded from
(therefore negating most of the costs methodology it sets out below. Thus, the coverage under the OSH Act (29 U.S.C.
associated with vaccination and testing Healthcare ETS profile used in this ETS 652(5)). Workers employed by these
under 29 CFR 1910.501). Third, any to account for employees exempted by entities only have OSH Act protections
underestimate of periodic costs will the Healthcare ETS into the Profile in if they work in states that have an
only apply during the first two months the event the Healthcare ETS expires OSHA-approved State Plan. (29 U.S.C.
after 29 CFR 1910.501 goes into effect (i.e., in Table IV.B.5, below) is an 667). Consequently, this analysis
and the standard has a delayed updated version of Table VI.B.3 in the excludes public entities in states that do
compliance date of 30 days after the Healthcare ETS (see 86 FR 32488).23 not have OSHA-approved State Plans.
effective date for most provisions, OSHA notes that some firms may decide Table IV.B.2 presents the states that
except for testing, which has a delayed to proactively comply with certain 29 have OSHA-approved State Plans and
compliance date of 60 days. This will CFR 1910.501 requirements (such as their public entities are included in the
further lessen the periodic costs mandating vaccination for all employees analysis.
OSHA notes, finally, that the not account for increases in vaccination point to determine the percentage of
percentage of employers mandating that would occur absent the standard, employees, by occupation, who are not
vaccination, and hence the employee resulting in a likely overestimate of the expected to work remotely (i.e., the
vaccination rate, would likely rise to costs. percentage of workers for whom
some degree absent this ETS due to employers have employee-based costs
c. Teleworking
other federal actions, such as the under this ETS) (Dingel and Neiman,
vaccination mandate for federal Dingel-Neiman Approach for Estimating July 2020).
contractors, the CMS rule published Who Can Work Remotely
In Dingel and Neiman’s paper, the
elsewhere in this issue of the Federal OSHA uses the estimates in a paper authors estimate the number of jobs in
Register, and as a result of vaccination by J.I. Dingel and B. Neiman, ‘‘How the U.S. economy that workers can
mandates that have been adopted at Many Jobs Can be Done at Home?,’’ feasibly perform remotely. The authors
state and local levels. This analysis does published in July 2020, as a starting use two different surveys from the
23 The CMS rule published elsewhere in this issue Medicaid. OSHA is ignoring this for the purpose of the CMS rule were not promulgated. This creates
of the Federal Register mandates vaccination for its cost analysis and taking costs into account as if a substantial overestimate.
employees in facilities that receive Medicare or
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61463
Occupational Information Network occupations can be performed remotely occupations for which the average
(O*Net) 24 to evaluate which and combine the O*Net estimates with response to a given prompt met a preset
the Bureau of Labor Statistics’ (BLS) threshold. Table IV.B.3 presents the
24 24 The O*Net Program is a major source of
Occupational Employment and Wage Dingel and Neiman response threshold
occupational information for the U.S. The O*NET
database surveys ask both specific occupational
Statistics (OEWS) data on employment for each survey question as well as the
experts and workers in those occupations questions by occupation to estimate the total percent of occupations that meet each
covering multiple aspects of almost 1,000 number of workers nationally who can respective predetermined threshold. For
occupations covering the entire U.S. economy. See work remotely. example, in 10.8 percent of occupations,
https://www.onetonline.org/ for more information.
The occupation definitions in the O*NET data are To evaluate the survey responses, the average response to the ‘‘Performing
Standard Occupation Codes—the same definitions Dingel and Neiman first determined the general physical activities’’ (4.A.3.a.1)
that are used in the BLS OEWS data. Dingel and question met the threshold, falling in
Neiman use the responses to two surveys included
in release 24.2 of the database administered by strongest agreement and 1 represents the strongest the range of 4 to 5.
O*NET, the Worker Context Questionnaire and the disagreement (see Table IV.B.3). The O*Net data Dingel and Neiman determined that
Generalized Work Activities Questionnaire. The contain the average response to each question for employees in a given occupation can
occupation with the median number of respondents each occupation code. For instance, for occupation telework full time if they did not meet
had 26 respondents for each work context question ‘‘Chief Executives’’ (SOC 11–1011), the average
and 25 respondents for each generalized work response to the prompt ‘‘Performing General the predetermined threshold for any of
activities question per detailed-level SOC Physical Activities is very important’’ was 1.39, the questions highlighted in grey and
occupation code. indicating that performing general physical activity denoted with a ‘‘Yes’’ in the column
In the O*Net Questionnaires, survey respondents is not, on average, critical to the work of chief that reports whether that activity is used
responded to statements about the nature and executives. The average responses by occupation for
requirements of the daily tasks associated with their other prompts in the relevant surveys utilized by in determining whether a job can be
job on a 1–5 ordinal scale, where 5 represents the Dingel and Neiman are contained in those surveys. done remotely in Table IV.B.3.
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61464 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
Source: (Dingel and Neiman, July 2020).
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61465
Adjusting Dingel and Neiman To Reflect gyms, casinos and places of worship), percent of the jobs in the United States
Current Conditions and, since more people have returned to are performed entirely at home, with
While many employees can and are the office, there is more need for significant variation across cities and
working remotely, many have returned childcare. Therefore, OSHA also industries. It should be noted that the
to their places of employment. This changed the status of these employees Dingel and Neiman analysis does not
conclusion is borne out by BLS’s and others from telework to non- specify a proportion of jobs that can be
Current Population Survey (CPS) (BLS, telework. This has the ultimate effect of performed at home part of the time;
2021c). To address the tendency toward increasing costs estimates for the rule. under the analysis, employees are either
Appendix A (Table A–1), in the working remotely full-time or are
employees returning to work on site and
accompanying document in the docket, working on site full time.
more accurately reflect current remote
‘‘Vaccination, and Testing ETS:
work conditions, OSHA made two The second adjustment OSHA made
Economic Profile and Cost Chapter
adjustments to Dingel and Neiman’s used monthly COVID-specific
Appendices’’ (OSHA, October 2021b),
estimates. In the COVID–19 Healthcare presents Dingel and Neiman’s (July teleworking data from telework
ETS, OSHA also used Dingel and 2020) unmodified percentages of questions added during the pandemic to
Neiman’s paper to estimate the number workers that can work remotely in each the CPS to estimate the reduction in
of workers who teleworked in response detailed occupation (based on BLS’s teleworking since its peak and applied
to the pandemic and the ETS under the Standard Occupation Code (SOC)).25 those estimates to further adjust
assumption that anyone who could Appendix A also presents, in separate downward the number of workers
work remotely would do so in response columns, percentages reflecting the currently teleworking (BLS, 2021c).
to the pandemic and the Healthcare modifications OSHA made in those Specifically, the CPS questions asked
ETS. Dingel and Neiman’s estimates are occupations where OSHA changed the respondents whether they were
therefore framed as the upper-bound of results from telework to non-telework teleworking due to COVID–19 (as
potential teleworking. for the reasons stated, as well as opposed to teleworking for other
The adjustments OSHA made reflect percentages reflecting the modifications reasons) and OSHA estimated the
changing circumstances. First, based on made in occupations where employees difference in teleworking from the peak
agency expertise, OSHA changed the work exclusively outdoors. of COVID-related teleworking in all
status of certain occupations in its According to the OSHA-adjusted industries, which occurred in May 2020,
occupational list from working remotely Dingel and Neiman estimates, 14 through August 2021 (see Table
to not working remotely. For example, IV.B.4).26 The reduction in teleworking
when Dingel and Neiman published 25 Except for the adjustments to Dingel and was then applied as the change in
their study, many schools were Neiman discussed above, OSHA used the Dingel percentage points to the estimated
operating virtually so the Dingel and and Neiman estimates for telework by occupation overall level of employees covered by
without change. The agency recognizes that the
Neiman finding that teachers were able authors’ methodology (i.e., the use of 0–1 the ETS in each NAICS code estimated
to work remotely lined up with the thresholds) led to a small number of results that based on data from Dingel and Neiman
situation where teachers were working may appear not to reflect real-world experiences (July 2020). OSHA’s final teleworking
remotely. At this point in the pandemic, within an occupation. However, Dingel and Neiman estimates are provided in Appendix B in
represents the best available evidence for
on the other hand, in-person learning determining the percentage of employees, by the accompanying document in the
has mostly recommenced. To this end, occupation, who are expected to work remotely. docket, ‘‘Vaccination, and Testing ETS:
OSHA changed the status of teachers OSHA is aware of no other source for this Economic Profile and Cost Chapter
and other employees in the education information that contains the level of detail Appendices’’ (OSHA, October 2021b).
necessary to conduct this analysis. Moreover, as
sector from working remotely to not explained above, OSHA modified the results for Reductions due to employees working
working remotely in this analysis. As individual occupations when it had a reasoned exclusively outdoors were applied to
another example, many activities that basis for doing so. In any event, every NAICS reduce the percentage of covered
ceased or were reduced significantly industry is comprised of many occupations, so for employees in Appendix B as well.
every occupation where OSHA suspects remote
have now resumed and many locations work is overestimated in Dingel and Neiman’s
that were closed to the public have results, there may be another where remote work is 26 The CPS data were available only at the 2-digit
reopened (e.g., athletic events, shows, underestimated. NAICS level as shown in Table IV.B.4.
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61466 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
Other Teleworking Literature maintain some physical workspace but anticipate they will not be returning to
now offer their employees who are the office in January 2022 or earlier
A number of companies have telework eligible the option to work (Chesto, June 22, 2021).
announced plans to allow employees to from home at least part of the time on Additional studies provide qualitative
work from home at least through the a permanent basis (Id.). Google, Ford, support for the conclusion that a range
end of 2021—suggesting that the levels of employees will ‘‘predictably’’ work
Amazon, Apple and other large
of remote work will not be returning to from home both during the pandemic
employers are expecting their telework
pre pandemic levels in the near future. and beyond. In Bick, Blandin, and
eligible workers to return to on-site
Many technology and internet based Martens’s paper, ‘‘Work from Home
work (in some capacity) no earlier than
companies, such as Dropbox, Coinbase, Before and After the COVID–19
VMWare, and Slack, have announced a January 2022 with Lyft anticipating a
Outbreak’’ the authors use the following
complete, permanent move to fully February 2022 return (Cerullo, August information to establish the physical
remote work (Courtney, September 27, 31, 2021). As a final example, a survey location of employment (home or
2021). Large employers such as of businesses in Massachusetts found workplace) of workers: Data from the
Facebook, Amazon, and Siemens plan to that about 40 percent of teleworkers Real-Time Population Survey (RPS), a
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61467
national labor market survey of adults contributing towards the more conditions for NAICS 111 and 112 using
between ages 18–64 that mirrors the permanent shift to telework: Diminished the average result for support activities
Current Population Survey (CPS) and stigma, better-than-expected for agriculture (NAICS 114 and 115). For
collects information used in pandemic experiences working from home, the postal service industry, NAICS
analysis, such as commuting behavior investments in physical and human 491110, which is not included in SUSB,
before and after the World Health capital enabling work from home, OSHA obtains total entity and
Organization declared a global reluctance to return to pre-pandemic employment data for private postal
pandemic; mobility data on commuting; activities, and innovation supporting services from the QCEW. Since these
and information from the CPS since work from home. data do not indicate the number of
May 2020 on ‘pandemic-related’ d. Affected Entities and Employees entities with more than 100 employees,
telework (Bick et al., February 2021). OSHA assumes it is the same as the
Based on these data, Bick et al., found OSHA used data from the U.S. average proportion as the related
that there was a sudden decline in Census’ 2017 Statistics of U.S. industries, couriers and express delivery
commuting trips in the U.S. after the Businesses (SUSB) to identify private (NAICS 492110), and local delivery
initial COVID–19 outbreak, and that sector entities and employees affected (NAICS 492120).
even when these trips subsequently by this section of the ETS (U.S. Census OSHA used the BLS 2020
began increasing back toward the Bureau, 2019), and used the BLS 2017 Occupational Employment and Wage
original number of commuting trips, the Quarterly Census of Employment and Statistics (OEWS), which provides
overall number of trips did not return to Wages (QCEW) to characterize state and NAICS-specific estimates of
normal at the end of 2020 because many local government entities (BLS, 2017). employment and wages by occupation,
teleworking employees continued SUSB provides estimates of entities and
along with the data in Appendix B
working from home. The authors found employees by employer size range,
(discussed earlier), to determine the
that the surge in work from home came which OSHA used to exclude employers
subset of non-teleworking employees
almost entirely from employees working with fewer than 100 employees.27
For rail transportation (NAICS 482), affected by the ETS.
from home every workday in the Table IV.B.5 summarizes the set of
reference week. The authors also suggest which is not included in SUSB or
QCEW data, OSHA relied on Federal entities covered by the ETS. OSHA
that, for some occupations, especially estimates a total of approximately
Railroad Administration and
those occupations with more educated 263,879 entities and approximately 1.9
Association of American Railroads
workers, the change to increased work million establishments incur costs
statistics reported in OSHA’s 2020 final
from home appears to be a long-term under the ETS.28 OSHA estimates these
rule, Cranes and Derricks in
change; the data showed that, as of entities employ approximately 102.7
Construction: Railroad Roadway Work.
December 2020, 12.5 percent of these million employees, and of these, OSHA
See 85 FR 57109 (September 15, 2020).
workers reported they expect to be estimates approximately 84.2 million
OSHA used these data sources to
working from home full-time in the employees are covered by the ETS and
identify public and private railroad
future, and 24.5 percent reported they are not excluded from coverage by
employers with more than 100
expect to be working from home part- working remotely 100 percent of the
employees. For agricultural NAICS (111
time. and 112), OSHA relies on the National time or exclusively outside.29 For the
In ‘‘COVID–19 and Remote Work: An purpose of this analysis, OSHA
Agricultural Statistics Service, 2017
Early Look At U.S. Data,’’ Brynjolfsson estimates that all employees that OSHA
Census of Agriculture (NASS, 2017) to
et al., noted that some of the shift to estimated will work remotely will
obtain estimates of total entities,
working from home seems to be a long- continue to do so for the duration of this
employees, and revenues. Since these
term phenomenon (Brynjolfsson et al., data do not indicate the number of ETS.30
June 2020). The authors found, using an entities with more than 100 employees,
online survey, that 35.2 percent of OSHA assumes it is the same as the 28 This includes public entities only in states with
workers had switched to working from average proportion as the support an approved OSHA State Plan. See Table IV.B.2
home. Additionally, 15 percent of activity sectors for crop and animal above for further discussion of state plans.
workers reported they were already production (NAICS 114 and 115). OSHA
29 OSHA’s estimate of covered employees is based
working from home before COVID–19. on the discussion in the text. For example, as OSHA
similarly specifies teleworking writes above: OSHA assumes for the purpose of its
Therefore, this study finds that about analysis that employers covered under the
half of workers are now working from 27 SUSB with revenue data is only collected every Contractor Guidance will conduct work at least
home—an even greater percentage than 5 years. While OSHA could attempt to extrapolate some of the time in workplaces not covered under
estimated by Dingel and Neiman. these data to more recent years, the results would that Guidance and so are fully integrated into the
be imprecise because they would change the scope of the ETS; and the employers and employees
Finally, in ‘‘Why Working from Home covered by the Healthcare ETS are also fully
revenue-employee size distributions. Those
Will Stick,’’ Barrero et al. predict that 22 distributions are crucial for measuring impacts so integrated into the scope of the ETS.
percent of all full workdays will be the agency has opted to use the data as is. The total 30 Conditions are changing rapidly, and though
performed from home after the number of employees in OSHA’s estimate is fairly many firms are planning to keep expanded telework
close to that of SUSB. The 2017 SUSB data includes to some extent, as the rate of vaccinated workers
pandemic ends, compared to 5 percent a total of 128.6 million employees, while the more increases, there may be increased movement back
before (Barrero et al., April 2021). The recent 2018 SUSB data includes a total of 130.9 to the workplace beyond what OSHA has estimated
authors highlight five factors million. here.
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61470 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
III. Baseline Vaccine Status for Covered the number who will test under the based on the total number of people
Employees ETS. OSHA’s methodology for this who are fully-vaccinated and had their
To estimate the cost of the ETS, analysis is detailed below. first shot in the past two weeks, as a
OSHA must first estimate the baseline fraction of the population in each age
a. Estimate the Current Vaccination Rate
vaccination status for the 84.2m covered for Covered Employees group, obtained from the BLS Current
employees (those who work for Population Survey (CPS) (BLS, 2021d).
employers with 100 or more employees To estimate the current vaccinate rate Then, to estimate the overall average
and are not otherwise excluded from for covered employees, OSHA obtained vaccination rate across age groups 18–74
coverage). OSHA recognizes that recent vaccination data by age group years old, OSHA weighted each group
employees’ current vaccination status from the CDC COVID Data Tracker based on the distribution of the labor
continues to change on a daily basis. (CDC, October 4, 2021a).31 For age force by age, also obtained from the BLS
When specifying baseline vaccination groups covering 18–74 years old, these CPS (BLS, 2021d). As shown in Table
rates, OSHA used the most recently data include the number of people who IV.B.6, OSHA estimates an overall
available vaccination data from CDC, are fully-vaccinated as well as the vaccination rate of 61.3 percent for
reflecting current conditions. For the number of people of who have initiated covered employees (and 38.7 percent
remaining set of unvaccinated their first shot in the past two weeks unvaccinated). The healthcare sector
employees covered by the ETS, after (relative to the October 4, 2021 data).32 had an earlier push to get healthcare
accounting for baseline vaccinations, OSHA estimates the vaccination rate for workers vaccinated and has a higher
OSHA estimates the number of these each group (percent of total population current rate, estimated to be 70
employees who will be vaccinated and in the age group who are vaccinated) percent.33
31 The data from the CDC website was retrieved sector. OSHA is including this group now that more the workplace and notes that more costs are
on October 4, 2021. of the other age populations have been vaccinated included than if the age group had been excluded
32 Age groups included: 18–24, 25–39, 40–49, 50– and those concerns are no longer as relevant. This from the analysis.
ETS will therefore indicate that a slightly higher 33 The agency takes a recent survey (Lazer et al.,
64, and 65–74. OSHA had not included the group
percentage of universe of covered employees is
65–74 in the economic analysis of the Healthcare vaccinated than if that age group of 65–74 was August 16, 2021) which breaks out rates for
ETS this past spring because for the healthcare excluded altogether, but it also increases the healthcare vaccination and non-healthcare, and
sector, using the population wide average of number of employees for which additional rather than replacing the CDC base vaccination rate
workers in this age bracket was felt would compliance costs are factored in. OSHA interprets uses the CDC rate to make an adjustment upwards
overcount the number of such workers in this the ultimate result as a more accurate reflection of to the healthcare rate of 70 percent.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61471
Based on the above, OSHA estimates remainder, who while unvaccinated, are and Washington data contain workers
that the 84.2m covered employees not hesitant because they are not in the that have applied, but not yet been
includes 52.5 million (62 percent) ‘‘probably or definitely will not’’ group accepted, for a religious exemption
vaccinated employees and 31.7 million (23.8 percent). (O’Sullivan, September 18, 2021; KEZI
unvaccinated employees (38 percent). Among those who are vaccine- News, September 25, 2021). In Oregon,
b. Adjust Baseline Vaccination for hesitant, OSHA estimates that 5 percent 5 percent and in Washington 8 percent
Continuing Trends of covered employees (or about 36 of the employees have requested
percent of the vaccine-hesitant), are accommodations though only a fraction
OSHA adjusts the current vaccination so far have been accepted. However, the
rate to account for continuing trends in hesitant due to a religious (4 percent) or
medical (1 percent) exemption. The data are not inconsistent with the
vaccinations among covered employees Vermont data even though the process
due to employers’ continued remaining 8.8 percent include those
who are vaccine-hesitant for other in both Oregon and Washington are not
implementation of vaccine mandates yet complete. For the 1 percent estimate
and other policies (described below), reasons. For the 4 percent estimate for
religious exemptions, OSHA relies on for medical exemptions, OSHA relied
under the ETS. To make this on the Household Pulse Survey (HPS)
adjustment, OSHA requires 1) further data from Vermont, which removed its
vaccine exemption for nonreligious conducted by the U.S. Census (U.S.
characterization of the set of
personal beliefs in 2016 and saw the Census Bureau, 2021). In Table 6a of the
unvaccinated employees in terms of
proportion of kindergarten students Health Tables for Week 31, September 1,
their likelihood to receive the vaccine,
with a religious exemption rise to about 2021 through September 13, 2021, about
and 2) specification of the extent of
4 percent (Graham, September 15, 1% of the US population said they
employer-mandated and other employer
vaccination policies. 2021). In analyzing this issue, the would not get the vaccine because
Based on vaccine confidence data agency also reviewed other religious ‘‘Doctor has not recommended it,’’ and
from CDC (CDC, October 2021a), 13.8 exemption data concerning state OSHA uses this response as a proxy for
percent of the population ‘‘probably or workers in Oregon and Washington; the all medical conditions.34
definitely will not’’ get the vaccine; agency decided not to rely on these data Table IV.B.7 presents the number of
hereafter referred to as ‘‘vaccine- because the Vermont data is a more employees in each vaccination category,
hesitant’’. Since this group is by accurate measure of the correct religious which informs OSHA’s subsequent
definition part of the currently exemption rate, although the data does estimates of which currently
unvaccinated, OSHA characterizes the represent parents deciding on whether unvaccinated employees may be
currently unvaccinated (37.6 percent) as to claim an exemption for their child, vaccinated by employer-mandates,
being comprised of those who are not for themselves. This is because, vaccinated under the ETS, or tested
vaccine—hesitant (13.8 percent) and the unlike the Vermont data, the Oregon under the ETS.
34 Table 6a presents that 3,884,902 of the 38,936,606 who will not get the vaccine for any the ones who won’t get the vaccine are about 10%
population will not take the vaccine because the reason. Medical reasons are then about 10% of the of the whole population, giving 1% (.10 * .10).
‘‘doctor has not recommended it’’ out of a total of general population that will not get the vaccine, and
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61472 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
Next, OSHA estimates the number of ETS and thereby increase the except for employees who are vaccine-
currently unvaccinated employees that vaccination rate (again because of hesitant, which includes not only those
are likely to become vaccinated while factors such as other federal vaccine who remain unvaccinated for medical
the ETS is in effect, based on their mandates), then the agency’s costs are and religious reasons, but also those
employers’ policies. Based on limited overestimated because the agency’s who are hesitant for any other reason.
data on current vaccine mandate baseline vaccination rate is too low. The OSHA carries through its assumptions
implementation and forecasts for future assumption of an increase from 25 to 60 and estimates into its total cost
implementation (Mishra and Hartstein, percent is based on the same set of estimates. For example, OSHA estimates
August 23, 2021; ASU COVID–19 surveys that indicate that the share of that the 25 percent of firms in scope that
Diagnostic Commons, October 6, 2021), employers who will mandate currently have a vaccination mandate
OSHA estimates that 25 percent of firms vaccinations after the ETS (including will not need to implement a new
in scope currently have a mandate, and those that already mandate written policy on vaccination in
assumes that this will rise to 60 percent vaccinations) range from 25–75 percent, response to the ETS since they will
of employers after the ETS is in place. see above references. The agency also already have implemented a policy that
The baseline of 25 percent is based on assumes that employees are distributed meets the requirements of the ETS.
recent surveys showing a range of in the same proportion across employers In total, OSHA estimates that 27
approximately 13–45 percent of with and without a vaccine mandate percent of covered employees (22.7
employers currently requiring or (e.g., if 60 percent of firms mandate million) will be vaccinated based on
planning to require vaccination among vaccination, 60 percent of employees employer policies under the ETS; or 72
employees (see Willis Towers Watson, will be vaccinated due to the mandate percent of covered employees who are
June 23, 2021; Mishra and Hartstein, (less those who remain unvaccinated currently unvaccinated. The resulting
August 23, 2021; ASU COVID–19 due to religious or medical exemptions). vaccination rate, adjusted for the ETS, is
Diagnostic Commons, October 6, 2021). OSHA assumes that all unvaccinated estimated based on the total of those
Absent the ETS, OSHA assumes that the employees subject to an employer who are currently vaccinated and those
percentage of firms would remain 25 mandate will be vaccinated under that who will be vaccinated under employer
percent (with some measure of upward employer mandate, except for those policies, 89.4 percent as shown in Table
adjustment due to other federal vaccine seeking a medical or religious IV.B.8. Calculations of this nature, while
mandates affecting select populations, exemption. For unvaccinated employees not discussed in more detail in this
as discussed above). To the extent more not subject to an employer mandate, analysis, are contained fully in the
firms than OSHA estimates would OSHA assumes that they will also be spreadsheets supporting this analysis
mandate vaccination independent of the vaccinated at their employer’s request, (OSHA, October 2021a).35
35 OSHA notes that these estimates differ for While OSHA does not describe in detail how it spreadsheets supporting this analysis. (OSHA,
employees covered by the Healthcare ETS. OSHA derived estimates for employees covered by the October 2021a).
calculated these estimates separately because, as Healthcare ETS in this analysis, the derivation of
stated above, OSHA is only taking costs for these those estimates run parallel to those described
employees in the last four months of the assumed above. For more information, please see the
6-month period while the ETS remains in effect.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61473
From Table IV.B.8, OSHA estimates overall average 22 percent of those who workers contracting COVID–19
that approximately 75.3 million (89.4 returned to work after teleworking (Groenewold et al., July 10, 2020).
percent) of covered employees will be earlier in the pandemic (see teleworking Absenteeism can also affect the
vaccinated when the ETS is in full discussion above), OSHA assumes for productivity of workers who are
effect, and that approximately 8.9 this cost analysis that only 22 percent of present, similar to how turnover can
million employees (10.6 percent, made workers needing a reasonable impose costs on incumbent workers
up of approximately 6.3 million covered accommodation will return to full time (Kuhn and Yu, April 2021).
employees who will be tested for COVID telework as a reasonable In aggregate, productivity losses from
under the ETS and approximately 2.6 accommodation. OSHA also assumes absences can be costly, as evidenced by
million employees who return to that the 78 percent remainder will the economic losses from seasonal
telework (see next paragraph)) will follow the testing/masking protocols in influenza. One estimate found that the
remain unvaccinated. This final set of the ETS as a reasonable accommodation. United States loses 20.1 million days of
unvaccinated employees includes all For hesitant employees who will not economic productivity every year due to
employees not vaccinated because of seek a religious or medical influenza, an ongoing loss equivalent to
religious or medical accommodations or accommodation, and who work in a 80,400 full-time worker-years (Putri et
medical contraindication, plus the firm with a testing option, the agency al., June 22, 2018). Another recent study
portion of those who are vaccine- assumes as above that those who were found that higher influenza vaccination
hesitant for any other reason, who were teleworking before (again on average 22 rates result in both fewer deaths and
not vaccinated because their employer percent) will return to telework rather significantly reduced illness-related
has opted for a voluntary vaccination than being tested. work absences (White, 2021).
OSHA recognizes that absenteeism
policy. c. Cost of Absenteeism to Employers has been a problem. However, as
From the above, OSHA estimates that Even mild cases of Covid-19 can be explained in other sections of the
about 5 percent of all covered costly to employers as they can induce preamble, the ETS vaccination and
employees will seek and receive productivity losses due to work testing and face covering requirements
religious or medical accommodations or absences, both among those infected are necessary to reduce the spread of
exemption for medical contraindication. and their close contacts who may be COVID–19 in the workplace, which may
While the agency encourages employers subject to quarantine requirements. in part reduce absenteeism. The ETS
to consider the most protective While many workers were able to might in a limited sense also increase
accommodations such as telework, engage in telework in March-April 2020, absenteeism because the rule requires
which would prevent the employee several occupational groups deemed employers to temporarily remove from
from being exposed at work or from essential, including childcare workers, the workplace any employee who
transmitting the virus at work, for cost personal care aids, healthcare support receives a positive COVID–19 test or is
analysis purposes the agency assumes occupations, and food processing diagnosed with COVID–19 by a licensed
these workers will largely be tested in workers, exhibited significantly higher healthcare provider. However, this
order for their employers to comply rates of absenteeism during that period, provision will also help to further
with the ETS. Consistent with the which the authors attributed to some reduce absenteeism because, when an
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61474 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
infected employee is promptly removed received 20,000 applications for 2,000 positive economic impacts accruing to
from the workplace, that can prevent flight attendant positions, a much employers that institute vaccine
one employee from infecting other higher ratio than before the pandemic mandates. These include reduced
employees in the workplace and (Chokshi and Scheiber, October 2, absenteeism due to fewer COVID–19
potentially causing an outbreak or a 2021). In addition, one survey reports illnesses and quarantines, as discussed
super-spreader event. Thus, OSHA that among employee resignations due above. Other positive economic impacts
concludes that the ETS may, on net, to COVID–19 workplace policies, 42 of a vaccine mandate are increased retail
help ameliorate absenteeism by percent reported lack of workplace trade from customers that feel less at
reducing illnesses, but in any event will safety policies, 17 percent reported that risk and better relations with suppliers
not increase absenteeism (see OSHA, existing workplace policies were not and other business partners. These all
October 2021c). stringent enough, and only 39 percent would contribute to improved business
reported overly restrictive workplace and increased profits.
d. The Effect of Employee Turnover The existence of these cost savings
policies, suggesting that many
One of the primary concerns among employees will welcome vaccine and other positive economic impacts
employers in imposing vaccination mandates (ASU COVID–19 Diagnostic accruing to employers that comply with
mandates is loss of staff, with 60 percent Commons, October 6, 2021).37 the ETS suggests that the actual net
of employers selecting it as a concern While employee turnover is a natural costs of the ETS could be much lower
with regard to mandating COVID–19 part of business in any industry, higher than the costs reported in this section of
vaccination, according to one survey employee turnover rate than normal can the economic analysis. As OSHA
(Mishra and Hartstein, August 23, have a direct impact on profit and discusses above, OSHA has provided
2021).36 To this end, employer revenue. The normal range of employee evidence to support its estimate that 25
vaccination mandates could lead to turnover differs widely by industry, percent of covered employers already
employee turnover; employees could with an average turnover rate of about voluntarily require that their employees
either leave on their own volition or 50 percent per year overall for the be vaccinated and a much larger
employers who have instituted strict private sector.38 For example, between percentage are considering a vaccine
vaccination policies may fire workers 2016 and 2020, employee turnover mandate. This supports the conclusion
who are not vaccinated, or place them ranged from 55 percent to 70 percent in that these businesses agree that doing so
on unpaid leave. the retail industry and from 40 percent will ultimately save costs.
On the other hand, there is to 60 percent in the transportation In addition, under the ETS, employers
countervailing evidence to suggest that industry (the industry sectors with the may implement a policy that allows for
employers who implement a vaccine highest employment).39 testing and face covering instead. Firms
mandate will be met with an influx of OSHA acknowledges that a vaccine will have a tendency to self-select: If a
potential workers. Many employees mandate may result in increased large proportion of its work force has
would prefer a mandate in place, and employee turnover, but one recent indicated concern about a vaccine
would be more likely to stay with, or survey 40 suggests it is very unlikely that mandate, the firm is more likely to
apply to, a firm that had a vaccine this potential increase in employee choose the testing option to retain their
mandate in place. For example, turnover will exceed the ranges that workers. This is one factor that led the
although Inova health system in industries have experienced over time. agency to estimate that approximately
Northern Virginia, lost 89 workers for The survey, though limited because 40 percent of employers will allow
noncompliance with the system’s many respondents did not have employees to choose testing and face
vaccination mandate, that loss mandates in place at that time, shows coverings in lieu of vaccination. To the
amounted to less than 0.5 percent of its that there was no impact on turnover for extent employers are concerned about
workforce, (Portnoy, October 3, 2021), 71 percent of those with mandates in employee testing costs, employers can
and, in any event, Inova’s CEO stated place. Only 25 percent saw a slight generally absorb testing costs or help
that the vaccine mandate has helped increase in turnover (1 percent to 5 employees reduce those costs through
with recruitment, and that its workers percent above normal) and only 4 low-cost assistance such as employer
are concerned for their own safety and percent saw a significant increase (more proctoring of tests (even though that is
want to know they are working with than 5 percent above normal). As such, not required by this ETS). Departure of
vaccinated colleagues. This same article OSHA does not anticipate that the personnel because of vaccine mandates
listed some other Virginia healthcare potentially increased employee turnover is also likely to be less common when
systems with higher rates of loss in attributable to vaccine mandates will be vaccine mandates are more prevalent
connection with vaccine mandates. substantial enough to negate normal across employers in a region or
Valley Health terminated 1 percent of its profit and revenue. industry. One survey reports that 65
employees, while Luminis Health had To this end, an important factor to percent of employers state that actions
about 2 percent of its workers still consider in examining turnover in of other companies in their industry are
unvaccinated at the time of its mandate connection with vaccine mandates is very, or at least moderately, important
deadline. As another example, although the unquantified cost savings and other in deciding to mandate vaccination
United Airlines had 593 employees (out (Mishra and Hartstein, August 23, 2021).
of the company’s 67,000 U.S. 37 This August 2021 global survey (all results Mandatory vaccinations for COVID–
employees) who had not complied with presented here are for the US only) has 1,143 19 are still relatively new because
the company’s vaccination mandate at responses. It covers 28 industries, including: vaccines only became available in
Technology and Software, Business and
the end of September (a number that Professional Services, Manufacturing, Construction, quantities sufficient to support such
dropped below 240 employees by and Healthcare. Ninety percent of respondents were mandates only about 6 months ago, and
October 1), the company reported it has from companies with more than 100 employees. the FDA has only recently moved past
38 BLS (March 11, 2021).
emergency clearance to final clearance.
39 Id.
36 This survey done in August, 2021, has 1,630
40 Umland, October 13, 2021. This October 2021
While there is not an abundance of
responses, reported by HR staff, attorneys, and evidence about whether employees have
executives. Described as being ‘‘from a variety of survey has 1,059 total respondents, though only 365
industries,’’ 83 percent of respondents were from have implemented a vaccination mandate and actually left or joined an employer
companies with more than 100 employees. answered this turnover question. based on a vaccine mandate,
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61475
particularly one with an alternative employers, it will not, on balance, add Costs are estimated using three labor
allowing for testing in lieu of significant new costs to covered rates for each NAICS industry: The
vaccination, OSHA has examined the employers or threaten the economic average labor rate for all employees, the
best available evidence it could locate in feasibility of any industry during a six labor rate for General and Operations
the timeline necessary to respond with month period. Managers (SOC code 11–1021), and the
urgency to the grave danger addressed OSHA seeks comments on these labor rate for Office Clerks, General
in this ETS. Based on that, OSHA is estimates and conclusions, as well as (SOC 43–9060). Industry-specific wage
persuaded that the net effect of the further data that it could use to refine rates are presented in Appendix C in the
OSHA ETS on employee turnover will its estimates. accompanying document in the docket,
be relatively small, given the option for IV. Cost Analysis for COVID–19 ‘‘Vaccination and Testing ETS:
employers to implement a testing and Vaccination and Testing ETS, Economic Profile and Cost Chapter
face covering policy and the § 1910.501 Appendices (OSHA, October, 2021b).’’
countervailing forces surrounding
turnover that will limit those effects, as In this section, OSHA provides b. Rule Familiarization, Employer
discussed above. estimates of the per-entity and total Policy on Vaccination, and Information
Finally, OSHA finds one line of costs for the requirements of this ETS. Provided to Employees
evidence particularly persuasive Section 6(c)(3) of the OSH Act states ETS Requirements
because it involves data instead of polls: that the Secretary will publish a final
standard ‘‘no later than six months after Section 1910.501(d)(1) of the ETS
While different surveys may suggest
different levels of worker intentions publication of the emergency standard.’’ specifies that the employer must
(joining or remaining with a safer Costs are therefore estimated over a six- establish and implement a written
employer versus leaving an employer to month time period. Note that the mandatory vaccination policy. The
avoid vaccination),41 the data suggests estimates are presented in this section at employer is exempted from the
that the number of employees who the 3-digit NAICS level, but the analysis requirement in paragraph (d)(1) only if
actually leave an employer is much was conducted at the 6-digit NAICS the employer establishes and
lower than the number who claimed level and aggregated to the 3-digit level implements a written policy allowing
they might: 1% to 3% or less actually for presentation purposes. The 6-digit any employee not subject to a
leave, compared to the 48–50% who NAICS level data is accessible in the mandatory vaccination policy to either
claimed they would.42 As discussed supporting spreadsheet. It should be choose to be fully vaccinated against
earlier, this turnover number is well noted that this analysis deals strictly COVID–19 or to provide proof of regular
below the average turnover rate in most with averages. For any given entity, testing for COVID–19 in accordance
industries. Thus, OSHA concludes that actual costs may be higher or lower than with paragraph (g) of the ETS and to
whether or not the ETS proves helpful the point estimate shown here, but wear a face covering in accordance with
to recruitment efforts for some using an average allows OSHA to paragraph (i) of the ETS.43
evaluate feasibility by industry as In addition, under § 1910.501(j),
41 Two polls from June 2021, when the number required by the OSH Act. In addition, information provided to employees, the
of COVID–19 cases had dropped dramatically just OSHA has limited data on many of the ETS requires the employer to inform
before the Delta Variant led to a surge in cases,
parameters needed in this analysis and each employee, in a language and at a
indicated that 50% of unvaccinated employees
surveyed said that they would leave their job rather has estimated them based on the literacy level the employee understand
than accept a vaccination mandate from their available data, estimates for similar about: (1) The requirements of the ETS
employer. (KFF et al., June 30, 2021) (the same requirements for other OSHA standards, as well as any employer policies and
percentage also responded that ‘‘The number of procedures established to implement
cases is so low that there is no need for more people
consultation with experts in other
to get the vaccine.’’). A separate poll from the same government agencies, and internal the ETS; (2) COVID–19 vaccine efficacy,
time also stated that 48% of ‘‘vaccine hesitant’’ agency judgment where necessary. safety, and the benefits of being
employees claimed they would quit their jobs rather OSHA’s estimates are therefore based on vaccinated; (3) the requirements of 29
than be vaccinated. (Barry et al., September 24, CFR 1904.35(b)(1)(iv) and Section 11(c)
2021—citing yet unpublished June 2021 poll). In a the best evidence available to the agency
more recent poll, about 44% of workers said that at the time this analysis of costs and of the OSH Act; and (4) the prohibitions
they would consider leaving their jobs if they were feasibility was performed. of 18 U.S.C. 1001 and Section 17(g) of
forced to get vaccinated, while around 38% of As mentioned above, OSHA estimates the OSH Act.
workers would consider leaving their current As stated, the ETS face covering
employer if the organization did not enact a vaccine
that approximately 264,000 entities
mandate. (Kelly August 12, 2021). Interestingly, in have employees who will be subject to requirements are contained in paragraph
that survey there was a direct correlation between the requirements of the ETS, including
the age of the worker and the desire to have a approximately 84.2 million employees. 43 Note to paragraph (d): Under federal law,
vaccinated workplace: Younger workers, usually including the Americans with Disabilities Act
the most mobile portion of the workforce, had a Many ETS requirements result in labor (ADA) and Title VII of the Civil Rights Act of 1964,
much higher desire for a vaccinated workforce burdens that are monetized using the some workers may be entitled to a reasonable
(50% of Generation Z employees, as compared to labor rates described next. accommodation from their employer, absent undue
33% of Baby Boomers). hardship. If the worker requesting a reasonable
42 An article titled ‘‘Unvaccinated Workers Say a. Wage Rates accommodation cannot be vaccinated against
They’d Rather Quit Than Get a Shot, but Data COVID–19 and/or wear a face covering because of
Suggest Otherwise’’ noted the 48%–50% threat to
OSHA used occupation-specific wage a disability, as defined by the ADA, or if the
leave, but included hard data showing nothing rates from BLS 2020 OEWS data (BLS, vaccination, testing, and/or wearing a face covering
close to those levels actually occurred: Houston 2021a). Within each affected 6-digit conflicts with the worker’s sincerely held religious
Methodist Hospital required its 25,000 workers NAICS industry, OSHA calculated the belief, practice or observance, the worker may be
(including its 3,580 unvaccinated employees) to get entitled to a reasonable accommodation. For more
a vaccine by June 7, and only 153 resigned or were
employee-weighted average wage to be information about evaluating requests for these
fired (4% of the 3,580 unvaccinated employees; used in the analysis. OSHA estimated types of reasonable accommodations for disability
0.6% of the total number of employees); other loaded wages using the BLS’ Employer or sincerely held religious belief, employers should
examples of the numbers of employees who left in Cost for Employee Compensation data consult the Equal Employment Opportunity
response to their employers’ mandatory vaccine Commission’s regulations, guidance, and technical
policy involved 5 out of 527 (0.9%), 2 out of 250
(BLS, 2021b), as well as OSHA’s assistance including at: https://www.eeoc.gov/wysk/
(0.8%), 6 out of 260 (3%), and 125 out of 35,800 standard estimate for overhead of 17 what-you-should-know-about-covid-19-and-ada-
(0.3%). (Barry et al., September 24, 2021). percent times the base wage. rehabilitation-act-and-other-eeo-laws.
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61476 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
(i) of the ETS. Under that paragraph, the OSHA is also estimating no costs in notes, that like the Healthcare ETS (id.),
employer, with certain exceptions connection with the employer providing the cost of implementing the plan for
specified in the ETS, must ensure that respirators to the employee. The ETS this ETS are included in the costs of
each employee who is not fully does not require the employer to implementing the corresponding
vaccinated wears a face covering when provide respirators to employees. requirements in the ETS, which are
indoors and when occupying a vehicle Therefore, any such provision is discussed below.
with another person for work purposes. voluntary and not relevant to economic To provide information to employees
The ETS does not require, nor does it feasibility of this rule. in accordance with paragraph (j) of the
prohibit, the employer to pay for any The face covering provisions in ETS, OSHA assumes a one-time average
costs associated with face coverings paragraph (i) contain several other labor burden per firm of 10 minutes of
(although employer payment for face requirements, none of which have costs manager time. The agency expects
coverings may be required by other associated with them. activities like posting the information
laws, regulations, or collective on a community board, mass emailing,
bargaining agreements or other Cost Analysis Assumptions
etc., will satisfy this requirement.
collectively negotiated agreements). In this section, OSHA estimates the
The total cost for rule familiarization,
However, the employer must permit the cost for establishing the employer policy
establishing an employer policy on
employee to wear a respirator instead of on vaccination, providing required
vaccination and providing required
a face covering whether required or not. information to employees, and rule
information to employees is calculated
In addition, the employer may provide familiarization. OSHA assumes each
as the product of:
respirators or face coverings to the entity will require an average one-time
employee, even if not required. In such labor burden of 1 hour of management • One-time labor burden for rule
circumstances, where the employer labor for rule familiarization. OSHA familiarization and establishing a policy
provides respirators, the employer must based this unit cost on that taken for (a total of 6 hours of manager time per
also comply with § 1910.504, Mini rule familiarization in the Healthcare entity) plus a one-time labor burden for
respiratory protection program. ETS (86 FR at 32496), but adjusted the providing information to employees (10
OSHA estimates no costs associated time downward by a half-hour because minutes of manager time per entity);
with an employee voluntarily bringing this ETS is a simpler standard than the • The labor rate for General and
in their own respirator to use instead of Healthcare ETS. Operations Managers (SOC code 11–
a face covering other than those costs To establish a written policy in 1021, NAICS-specific wages); and,
that OSHA is estimating below in accordance with paragraph (d) of the • The total number of covered
connection with 29 CFR 1910.501(j), ETS, OSHA assumes a one-time average entities.
information provided to employees. labor burden of 5 hours of manager time
That section provides, again, that the Cost for Employer Policy on Vaccination
per firm. OSHA bases this estimate on and Information Provided to Employees
employer must inform each employee, its cost estimates in the Healthcare ETS,
in a language and at a literacy level the where OSHA estimated that Costs per entity and total costs for
employee understands about the development of the COVID–19 Plan employer policy on vaccination and
requirements of the ETS as well as any required by that standard would take information provided to employees are
employer policies and procedures between 5 and 40 hours (see 86 FR at shown below in Table IV.B.9.
established to implement the ETS. One 32496–32497). OSHA concludes that 5 BILLING CODE 4120–01–P
policy the employer would need to hours is a reasonable estimate because
establish to implement the ETS is a the development of a written policy on the time to create the various processes under the
policy to comply with the requirements vaccination will be much simpler than CMS rule published elsewhere in this issue of the
of 29 CFR 1910.504 when an employee the development of the written COVID– Federal Register since the requirements of what is
voluntarily brings in their own 19 Plan required by the Healthcare ETS needed to be included in the plans differ. For
respirator. Those requirements require example, the CMS plan requires a process for
(see 29 CFR 1910.502(c)).44 OSHA ensuring the implementation of additional
only that the employer provide certain precautions to mitigate the transmission and spread
information to the employee (see 29 44 The estimates for the time to create the written of COVID–19 while OSHA’s vaccination policy
CFR 1910.504(c)). vaccine policy plan under this ETS may differ from requirements do not include this requirement.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61477
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61478 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
BILLING CODE 4120–01–C vaccinated, which is 2 weeks after the • The record of immunization from a
c. Determining Employee Vaccination full required vaccine course is health care provider or pharmacy;
Status completed. • A copy of the COVID–19
ETS Requirements Paragraph (e)(2). The employer must Vaccination Record Card;
require each vaccinated employee to • A copy of medical records
Under § 1910.501(e): provide acceptable proof of vaccination documenting the vaccination;
Paragraph (e)(1). The employer must status, including whether they are fully
• A copy of immunization records
determine the vaccination status of each or partially vaccinated. Acceptable
from a public health, state, or tribal
employee. This determination must proof of vaccination status is:
include whether the employee is fully immunization information system; or
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61479
• A copy of any other official d. Employer Support for Employee to a vaccination site (for a total of 30
documentation that contains the type of Vaccination minutes). OSHA then estimates 5
vaccine administered, date(s) of ETS Requirements minutes to wait, fill out any necessary
administration, and the name of the paperwork, and receive the shot, and a
health care professional(s) or clinic Under 29 CFR 1910.501(f): post-shot wait time of 20 minutes, per
site(s) administering the vaccine(s). The employer must support COVID– employee. Some firms, particularly
In instances where an employee is 19 vaccination by providing: larger ones, will find it cheaper to have
• Time for vaccination. The employer vaccines administered on site. They
unable to produce acceptable proof of
must: (i) Provide a reasonable amount of may have an on-site health clinic or may
vaccination, per above, a signed and
time to each employee for each of their hire a 3rd party purveyor to come to the
dated statement by the employee,
primary vaccination series dose(s); and facility.46 This will minimize travel and
subject to criminal penalties for (ii) provide up to 4 hours paid time,
knowingly providing false information: also allow the companies to mitigate
including travel time, at the employee’s some of the logistical issues that may be
• Attesting to their vaccination status regular rate of pay for this purpose.
(fully vaccinated or partially preventing employees from receiving a
• Time for recovery. The employer
vaccinated); and vaccine (finding a convenient
must provide reasonable time and paid
• Attesting that they have lost and are appointment time, etc.). OSHA
sick leave to recover from side effects
otherwise unable to produce proof estimates that 10 percent of firms with
experienced following any primary
required by the ETS. employees between 100 to 500
vaccination series dose to each
Paragraph (e)(3). Any employee who employees will select this option, while,
employee for each dose.
does not provide one of the acceptable Under the ETS, fully vaccinated given decreased average costs associated
forms of proof of vaccination status in means (i) a person’s status 2 weeks after with economies of scale, 25 percent of
paragraph (e)(2) of the ETS to the completing primary vaccination with a firms with over 500 employees will
employer must be treated as not fully COVID–19 vaccine with, if applicable, select this option. OSHA was unable to
vaccinated for the purpose of the ETS. at least the minimum recommended obtain an estimate of the cost savings
Paragraph (e)(4). The employer must interval between doses in accordance associated with on-site vaccination in
maintain a record of each employee’s with the approval, authorization, or the time allotted to issue this emergency
vaccination status and must preserve listing that is: (A) Approved or standard, so it is assuming that the costs
acceptable proof of vaccination for each authorized for emergency use by the for off-site vaccination are the same as
employee who is fully or partially FDA; (B) listed for emergency use by the the costs for on-site vaccination. This
vaccinated. The employer must World Health Organization (WHO); or results in a likely over-estimate of costs
maintain a roster of each employee’s (C) administered as part of a clinical given that the entities that choose the
trial at a U.S. site, if the recipient is on-site option will do so as a cost-saving
vaccination status. These records and
documented to have primary measure.
roster are considered to be employee
In OSHA’s cost analysis, OSHA
medical records and must be vaccination with the ‘‘active’’ (not
assumes that all employees will be
maintained as such records in placebo) COVID–19 vaccine candidate,
vaccinated during working hours and
accordance with 29 CFR 1910.1020 and for which vaccine efficacy has been
employers would adjust the employee
must not be disclosed except as required independently confirmed (e.g., by a data
work schedule to ensure that the
or authorized by the ETS or other and safety monitoring board), or if the
employee would not become eligible for
federal law. These records and roster are clinical trial participant from the U.S.
overtime pay as a result of the
not subject to the retention requirements site had received a COVID–19 vaccine
vaccination time. However, it should be
of 29 CFR 1910.1020(d)(1)(i) but must be that is neither approved nor authorized
noted that, if an employee chooses to
maintained and preserved while the for use by FDA but is listed for
receive the vaccine outside of work
ETS remains in effect. emergency use by WHO; or (ii) a
hours, OSHA does not require
Paragraph (e)(5). Finally, when an person’s status 2 weeks after receiving
employers to grant paid time to the
employer has ascertained employee the second dose of any combination of employee for the time spent receiving
vaccination status prior to the effective two doses of a COVID–19 vaccine that the vaccine during non-work hours
date of this section through another is approved or authorized by the FDA, (although other laws may include
form of attestation or proof, and retained or listed as a two-dose series by the additional requirements for employers,
records of that ascertainment, the WHO (i.e., heterologous primary series such as those addressing reasonable
employer is exempt from the of such vaccines, receiving doses of accommodations or exemptions).
requirements in paragraphs (e)(1)–(e)(3) different COVID–19 vaccines as part of OSHA’s analysis may be an
only for each employee whose fully one primary series). The second dose of overestimate as it reflects an assumption
vaccinated status has been documented the series must not be received earlier that all vaccinations are received during
prior to the effective date of this section. than 17 days (21 days with a 4-day grace work hours.
For purposes of paragraph (e)(4), the period) after the first dose. CDC data indicated that 5 percent of
employer’s records of ascertainment of Cost Analysis Assumptions employees vaccinated have received the
vaccination status for each such person Johnson & Johnson vaccine, and 95
constitute acceptable proof of OSHA assumes there will be no costs percent have received either Pfizer or
vaccination. to employers or employees associated Moderna (CDC, October 2021b). OSHA
The full costs for these provisions are with the vaccine itself.45 However, to applies the same allocation to
taken under the costs for recordkeeping, provide support for vaccination of employees being vaccinated under the
discussed below, because determining employees, OSHA estimates that it will ETS. For those receiving Pfizer or
vaccination status, providing acceptable take an average of 15 minutes of travel Moderna, the labor burden outlined
proof of vaccination status, and creating time, each way, per employee to travel
and maintaining a roster of each 45 While there may be some administrative costs
46 Prior to the effective date of this rule, some
employee’s vaccination status will be companies offered on-site vaccination according to
borne by the government, such costs are not a limited survey. (Willis Towers Watson, June 23,
part and parcel of the recordkeeping germane to this analysis of whether the ETS is 2021). See also CDC on creating an on-site program
process. economically feasible for covered employers. (CDC, March 25, 2021; CDC, October 4, 2021b).
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61480 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
above occurs twice, since vaccination Because there is the same number of wage by NAICS to calculate the cost per
requires two shots. days across all levels of employee employee. Since OSHA does not know
The employer must provide tenure (1 year, 5 years, 10 years, and 20 which firms make up the 12 percent, the
reasonable time and paid sick leave to years), OSHA used 9 days for all agency spreads this total cost across all
recover from side effects experienced covered employees. The agency assumes firms by employee. Since firms without
following any vaccination dose to each that 75% of the available paid sick leave any sick leave are likely to be lower-
employee for each vaccination dose. has been used by the current 4th quarter wage firms, this will likely lead to a cost
Employers may require employees to of the calendar year. So the average overestimate.
use paid sick leave benefits otherwise number of days available is 1.98 days: Therefore, the total cost for paid time
provided by the employer to offset these 9 (days) * 88% (employees with off for vaccination is based on the costs
costs, if available. The average amount available paid sick leave) * 25% for providing paid sick leave for the 12
of time off an employee may need for (amount of leave remaining in the year) percent of firms that do not offer paid
side effects while receiving the vaccine = 1.98 days available. Given that the sick leave and:
doses necessary to achieve full average overall time out due to side • Travel time per employee of
vaccination (one or two doses, effects is 0.36 days (see above), OSHA covered firms of 15 minutes each way
depending on the vaccine) depends on concludes that, on average, employees per vaccination dose (total of 30
several factors. First, the percentage of should have sufficient existing paid sick minutes).
people who will have side effects that leave available to cover the time needed • Pre-shot wait time per employee of
are severe enough to require time. as a result of vaccine-related side covered firms of 5 minutes per
Second, the average time duration for effects. As a result, OSHA is taking no vaccination dose.
those who have such a severe reaction. costs to employers in connection with • Post-shot wait time per employee of
For estimates of these parameters OSHA the ETS’s requirement to provide time covered firms of 20 minutes per
is using a recent study (Levi et al., for recovery from vaccination (except as vaccination dose.47
September 29, 2021) which surveyed provided below), as these costs will • The average labor rate for
workers at a state-wide health care have been incurred by the employer employees (NAICS-specific wages).
system who had been vaccinated. The independent of the ETS. • Total number of employees at
study found that, for the first dose, 4.9% While this analysis is entirely covered firms getting vaccinated due to
needed administrative leave, with an consistent with OSHA’s standard the ETS with the Johnson & Johnson
average length of absence of 1.66 days. procedure of strictly using averages in vaccine.
For the second dose, 19.79% needed cost analysis, it nonetheless masks some • Total number of employees at
leave and their average length of significant effects resulting from the covered firms getting vaccinated due to
absence was 1.39 days. Together, the time for recovery requirements. From the ETS with the Pfizer and Moderna
average time on leave is .36 days (.049 the BLS data, OSHA knows there are vaccines, multiplied by two to account
* 1.66 + .1979 * 1.39) for a person 12% of establishments that have 100+ for two shots.
receiving two doses, which reflects the employees and do not provide paid sick
fact that many people who receive the leave. Correspondingly, there is a group Cost for Support for Employee
vaccine do not have any side effects for of entities with no paid sick leave that Vaccination
either dose while others have more will obviously incur costs that result Costs per firm and total costs for
severe side effects. directly from these requirements. In vaccination are shown below in Table
In order to determine the amount of addition, some employees may not IV.B.10.
paid sick leave that would be available have, or some other entities may not BILLING CODE 4120–01–P
to employees, OSHA relied on data from offer, sufficient paid sick leave to cover
BLS (BLS, 2021e). BLS estimates that for these costs. 47 According to the CDC, people with allergies
civilian workers in establishments with To account for the 12 percent of firms require a wait time of 30 minutes, but they are a
100+ employees, 88% have access to that do not offer paid sick leave, the small group, and, in any event, the CDC
recommends that routine wait time is 15 minutes,
paid sick leave (Table 33). BLS states agency uses the above estimate of so the agency considers that its average of 20
that the average number of paid sick average days for two doses, 0.36 days, minutes is probably an overestimate. (See CDC,
leave available is 9 days (Table 36). and multiplies the average employee October 4, 2021a; CDC, March 3,2021.)
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61482 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
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61484 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
BILLING CODE 4120–01–C because providing documentation of test CoV–2 that is: (i) Cleared, approved, or
e. COVID–19 Testing for Employees results to the employer will be part and authorized, including in an Emergency
Who Are Not Fully Vaccinated parcel of the recordkeeping process. Use Authorization (EUA), by the FDA to
Employees who are partially detect current infection with the SARS–
ETS Requirements vaccinated are also required to be tested CoV–2 virus (e.g., a viral test); (ii)
Section 1910.501(g)(1) of the ETS weekly until they are fully vaccinated. Administered in accordance with the
requires the employer to ensure that Those receiving the J&J vaccine will authorized instructions; and (iii) Not
each employee who is not fully require two weeks of testing after the both self-administered and self-read
vaccinated do the following: single shot, employees who received the unless observed by the employer or an
An employee who reports at least Pfizer-BioNTech Vaccine will require 5 authorized telehealth proctor. Examples
once every 7 days to a workplace where weeks of testing (3 weeks between shots of tests that satisfy this requirement
other individuals, such as coworkers or and 2 weeks following the second shot), include tests with specimens that are
customers, are present: and Moderna recipients require 6 weeks processed by a laboratory (including
• Must be tested for COVID–19 at of testing (4 weeks between shots and 2 home or on-site collected specimens
least once every 7 days; and weeks following the second shot) (CDC, which are processed either individually
• Must provide documentation of the October 4, 2021b). Notwithstanding this, or as pooled specimens), proctored over-
most recent COVID–19 test result to the in the agency’s total cost estimate OSHA the-counter tests, point of care tests, and
employer no later than the 7th day accounts for the fact that employers tests where specimen collection and
following the date on which the need not comply with the requirements processing is either done or observed by
employee last provided a test result. of this section in paragraph (g) by 60 an employer. Employers may have costs
An employee who does not report days after the rule’s effective date, and associated with doing, observing or
during a period of 7 or more days to a that employees who have completed the proctoring employee testing, if
workplace where other individuals, entire primary vaccination series by that employers choose to do so. However, for
such as coworkers or customers, are date do not have to be tested, even if economic feasibility purposes, OSHA
present (e.g., teleworking for two weeks they have not yet completed the 2 week does not account for these costs in its
prior to reporting to a workplace with waiting period. estimates because they are not required
others): There is no requirement in the rule for compliance with the ETS.
• Must be tested for COVID–19 that the employer pay for this testing so
within 7 days prior to returning to the these testing-related costs are not Costs Associated with Reasonable
workplace; and included in the main analysis (although, Accommodation: Testing, Face
• Must provide documentation of that as discussed below OSHA takes into Coverings, and Determinations
test result to the employer upon return account costs for testing in connection The ETS does not require the
to the workplace. with the ETS’s recordkeeping
Furthermore, if an employee does not employer to pay for any costs associated
requirements). The agency estimates with testing; however employer
provide documentation of a COVID–19 that 6.3 million weekly tests will need
test result as required by paragraph payment for testing may be required by
to be given due to this ETS (see Table other laws, regulations, or collective
(g)(1) of the ETS, the employer must IV.B.8). This 6.3 million is likely an
keep that employee removed from the bargaining agreements. Thus, while
overestimate of new costs because it OSHA does not include any costs for
workplace until they provide a test encompasses tests for employees who
result. In addition, when an employee reasonable accommodation requests in
were already required to conduct testing its main cost analysis in recognition that
has received a positive COVID–19 test, by their employers prior to this ETS.
or has been diagnosed with COVID–19 such costs would result from the
OSHA also notes that its cost
by a licensed healthcare provider, the application of other laws, OSHA notes
estimates for testing do not take into
employer must not require that that even if employers were to agree to
account the 90-day break in testing that
employee to undergo COVID–19 testing pay for COVID–19 testing as part of a
occurs following the date of a positive
as required under paragraph (g) of this reasonable accommodation or some
test or diagnosis. OSHA’s cost estimates
section for 90 days following the date of other reason required by law, such costs
are also potentially overcounting costs
their positive test or diagnosis. Finally, would not alter OSHA’s findings
in that OSHA does not take into account
the employer must maintain a record of regarding the economic feasibility of the
that not all employees for whom testing
each test result provided by each rule.48 OSHA reached this conclusion
is required will report at least once
employee under paragraph (g)(1) of this after conducting a separate analysis of
every 7 days to a workplace where other
section or obtained during tests reasonable accommodation costs that an
individuals, such as coworkers or
conducted by the employer. These employer might assume if they do not
customers, are present. Thus, OSHA’s
records are considered to be employee represent an undue hardship for the
estimate assumes that employees for
medical records and must be employer. This analysis is available in
whom testing is required will need to be
maintained as such records in the docket at OSHA, October 2021d.
tested at least once every 7 days and not
accordance with 29 CFR 1910.1020 and OSHA notes that this separate
less frequently as will often be the case.
must not be disclosed except as required OSHA notes, in addition, that there analysis is limited to employees who
or authorized by this section or other are no costs associated with paragraph request accommodation, and accounts
federal law. These records are not (g)’s removal provision. The ETS does for costs of reviewing medical and/or
subject to the retention requirements of not require the employer to provide religious accommodation requests, as
29 CFR 1910.1020(d)(1)(i) but must be paid time off to any employee for 48 OSHA notes that while the testing required
maintained and preserved while this removal as a result of the employee’s under this standard might be an option for
section remains in effect. refusal/failure to provide employees who request a reasonable
OSHA addresses the costs associated documentation of a COVID–19 test accommodation to avoid vaccination, other
with testing in the next section. The result as required by paragraph (g)(1) of alternatives such as telework would be more
protective to the employee by preventing COVID–
remaining costs required by paragraph the ETS. 19 exposure. These alternatives may also be
(g) are taken under the costs for Finally, OSHA notes that a COVID–19 available at no additional cost to the employer or
recordkeeping, discussed below, test under the ETS is a test for SARS– employee.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61485
well as costs for COVID–19 testing and With respect to notification, to the analysis is broadly consistent, using
face coverings that would satisfy the extent employee notification is updated data, with OSHA’s analysis of
requirements of this ETS. OSHA expects connected to the ETS’s testing and a nearly identical provision in 29 CFR
a reasonable accommodation request documentation requirements in 1910.502, the Healthcare ETS. OSHA
could lead to a review of the employee’s paragraph (g), those costs to the also estimates, based on the Healthcare
request by a manager and then a employer are taken under the costs for ETS, that reporting of each fatality and
conference between the manager and recordkeeping, discussed below, hospitalization will require 45 minutes
the employee. OSHA concludes that the because, as explained above, receiving of an employer’s time (86 FR at 32516).
combination of these costs would not documentation of test results under This includes hospitalizations and
alter OSHA’s findings regarding the paragraph (g) will be part and parcel of fatalities for employees that remain
economic feasibility of the ETS. the recordkeeping process. unvaccinated, as well as a small
OSHA notes also that the costs percentage of hospitalizations and
f. Employee Notification to Employer of associated with employee notification fatalities of vaccinated employees due to
a Positive COVID–19 Test and Removal by vaccinated employees (not required breakthrough cases. Because of the
ETS Requirements by this ETS to undergo testing) should timing requirements in the rule, the
Under § 1910.501(h): also be negligible because it will not agency assumes that a hospitalization
Regardless of COVID–19 vaccination occur with any real frequency. The very followed by a death will need two
status or any COVID–19 testing required low breakthrough rates of infection reports from the employer (i.e., the
under paragraph (g) of the ETS, the among vaccinated persons suggests that agency assumes that reporting for
employer must: the overwhelming majority of COVID– hospitalizations will occur within 8
• Require each employee to promptly 19 cases reported to a covered employer hours, before reporting for fatalities
notify the employer when they receive will be in the pool of unvaccinated occurs, within 24 hours). This will
a positive COVID–19 test or are employees. result in a slight over-estimate.
diagnosed with COVID–19 by a licensed g. Reporting COVID–19 Fatalities and The total cost for reporting COVID–19
healthcare provider; and Hospitalizations to OSHA fatalities and hospitalizations to OSHA
• Immediately remove from the is calculated as the product of:
workplace any employee who receives a ETS Requirements
• One-time labor burden of 45
positive COVID–19 test or is diagnosed Under § 1910.501(j): minutes per report of hospitalization or
with COVID–19 by a licensed healthcare The employer must report to OSHA: fatality.
provider and keep the employee • Each work-related COVID–19
• Wage range for General and
removed until the employee: (i) fatality within 8 hours of the employer
Operations Managers (SOC code 11–
Receives a negative result on a COVID– learning about the fatality.
• Each work-related COVID–19 in- 1021, NAICS-specific wages).
19 nucleic acid amplification test • Total number of fatalities for
(NAAT) following a positive result on a patient hospitalization within 24 hours
of the employer learning about the in- employees at covered firms.
COVID–19 antigen test if the employee
patient hospitalization. • Total number of hospitalizations for
chooses to seek a NAAT test for
When reporting COVID–19 fatalities employees at covered firms.
confirmatory testing; (ii) meets the
return to work criteria in CDC’s and in-patient hospitalizations to OSHA Cost for Reporting COVID–19 Fatalities
‘‘Isolation Guidance’’ (incorporated by in accordance with paragraph (j)(1) of and Hospitalizations to OSHA
reference, § 1910.509); or (iii) receives a the ETS, the employer must follow the
requirements in 29 CFR part 1904.39, Costs per entity and total costs for
recommendation to return to work from
except for 29 CFR part 1904.39(a)(1) and vaccination are shown below in Table
a licensed healthcare provider.
(2) and (b)(6). IV.B.11.
Costs Analysis Assumptions
Cost Analysis Assumptions number of hospitalizations and fatalities to
The ETS does not require employers
to provide paid time off to any OSHA estimates a total of 1,464 vaccinated employees is calculated in a similar
fatalities and 59,570 hospitalizations for fashion, but with a lower infection rate because
employee for removal from the vaccination makes it considerably less likely that an
workplace as a result of a positive employees of covered firms.49 This individual will be tested and found to be infected.
COVID–19 test or diagnosis of COVID– See (OSHA, October 2021a and OSHA, October
49 These counts represent hospitalizations and 2021c). One difference in methodology between
19; however paid time off may be fatalities that would occur to the in-scope labor these counts and the Health Impacts analysis is that
required by other laws, regulations, or force despite the ETS. The numbers are derived these counts use a baseline of the last 19 months
collective bargaining agreements or using methodology similar to that used in Health of CDC data to estimate the case fatality rate (similar
other collectively negotiated Impacts to generate hospitalizations and fatalities to Alternative C in the Health Impacts analysis),
prevented. An infection rate and case fatality rate rather than a baseline of the last 6 months (which
agreements. Therefore, there are no are multiplied by the number of unvaccinated OSHA used for the main Health Impacts analysis).
costs associated with paragraph (h)’s workers to derive a total number of fatalities. That This results in an estimate toward the upper bound
removal provision. number is used to derive hospitalizations. The for these counts (i.e., an overestimate of costs).
App. 85
61486 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61487
h. Recordkeeping record of each employee’s vaccination not subject to the retention requirements
ETS Requirements status and must preserve acceptable of 29 CFR 1910.1020(d)(1)(i) but must be
proof of vaccination for each employee maintained and preserved while the
As discussed above, the full costs for who is fully or partially vaccinated. The ETS remains in effect.
the requirements in paragraph (e) of the employer must also maintain a roster of With respect to vaccination, it should
ETS are taken under the costs for each employee’s vaccination status. be noted that, under paragraph (e)(5) of
recordkeeping because determining These records and roster are considered the ETS, when an employer has
vaccination status, providing acceptable ascertained employee vaccination status
to be employee medical records and
proof of vaccination status, and creating prior to the effective date of this section
must be maintained in accordance with
and maintaining a roster of each through another form of attestation or
employee’s vaccination status will be 29 CFR 1910.1020 as such records and
proof, and retained records of that
part and parcel of the recordkeeping must not be disclosed except as required ascertainment, the employer is exempt
process. Under paragraph (e)(4) of the or authorized by the ETS or other from the determination of vaccination
ETS, the employer must maintain a federal law. These records and roster are requirements in paragraphs (e)(1)–(e)(3)
App. 87
61488 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
only for each employee whose fully consent of that employee. In addition, OSHA notes that there will be a cost
vaccinated status has been documented under paragraph 1910.501(l)(2) of the associated with setting up the
prior to the effective date of this section. ETS, by the end of the next business day recordkeeping system (e.g., a
For purposes of the recordkeeping after a request by an employee or an spreadsheet) used to comply with the
requirements in paragraph (e)(4), the employee representative, the employer ETS. OSHA takes these costs in
employer’s records of ascertainment of must make available to the requester the connection with the costs for the
vaccination status for each such person aggregate number of fully vaccinated employer policy on vaccination, which
constitute acceptable proof of employees at a workplace along with are described above.
vaccination. OSHA estimates, based on the total number of employees at that
Given the relative complexity of
this provision, that 60% of employees workplace. Under paragraph
who were vaccinated prior to the 1910.501(l)(3) of the ETS, the employer recordkeeping in the Healthcare ETS,
promulgation of the ETS will not need must also provide to the Assistant OSHA has simplified its assumptions to
to document vaccination status in Secretary for examination and copying: reflect a variety of small costs in a
connection with paragraph (e) (ASU (i) Within 4 business hours of a request, combined estimate. As in the Healthcare
COVID–19 Diagnostic Commons, the employer’s written policy required ETS, the cost estimate of 5 minutes per
October 6, 2021). by paragraph (d) of the ETS, and the event is likely much higher than
As also discussed above, the costs for aggregate numbers described in necessary to account for just the actions
the requirements for documenting test paragraph (l)(2) of the ETS; and (ii) By of receiving and maintaining copies of
results in paragraph (g), including the the end of the next business day after a records, so retaining this time will yield
timing for when recordkeeping costs for request, all other records and other a tendency toward overestimation.
testing accrue under the ETS, are taken documents required to be maintained by However, this cost also reflects a margin
under the costs for recordkeeping the ETS. to encompass additional outlier costs
because providing documentation of test such as a second documentation of
results to the employer will be part and Cost Analysis Assumptions
vaccination status for all employees
parcel of the recordkeeping process. To fulfill the recordkeeping who need to submit documentation
Under paragraph (g)(4) of the ETS, the requirements in the ETS, OSHA twice (first for partial vaccination and
employer must maintain a record of estimates that it will take an average of then for full vaccination) under the ETS.
each test result provided by each 5 minutes of clerical time per employee This 5 minutes for recordkeeping also
employee under paragraph (g)(1) of the record. OSHA bases this cost estimate encompasses the marginal time for
ETS or obtained during tests conducted on the estimate for recordkeeping in the creating and maintaining a roster of
by the employer. These records must be Healthcare ETS (86 FR at 32515). While each employee’s vaccination status
maintained in accordance with 29 CFR OSHA estimated an average of 10 (paragraph (e)) and making aggregate
1910.1020 and must not be disclosed minutes of clerical time per employee employee data available (paragraph (l)).
except as required or authorized by this record in the Healthcare ETS, that Since normally the system used for
section or other federal law. These standard includes more extensive recordkeeping will be electronic in
records are not subject to the retention recordkeeping requirements than what businesses with more than 100
requirements of 29 CFR is being required under this ETS. See 29 employees, the time to create an
1910.1020(d)(1)(i) but must be CFR 1910.502(q)(2)(ii) (Healthcare ETS aggregate report and a roster should be
maintained and preserved while this record must contain, for each instance, de minimis. Finally, this inflated
section remains in effect. the employee’s name, one form of
recordkeeping cost encompasses time
With respect to testing, it should be contact information, occupation,
for employee notification to the
noted that, under paragraph (m) of the location where the employee worked,
employer of a positive COVID–19 test
ETS, employers are not required to the date of the employee’s last day at the
connected to the ETS’s testing and
comply with the requirements in workplace, the date of the positive test
documentation requirements in
paragraph (g) of the ETS until 60 days for, or diagnosis of, COVID–19, and the
paragraph (g),which is a notification
after the effective date of the ETS, date the employee first had one or more
under paragraph (h). Finally, the burden
meaning that for cost analysis purposes COVID–19 symptoms, if any were
of making available, for examination
OSHA assumes that employers would experienced).
In addition, OSHA includes in this and copying, the individual COVID–19
not receive any testing records until the
estimate 5 minutes of employee time to vaccine documentation and any
end of that 60-day period.
Finally, under paragraph provide documentation of vaccination COVID–19 test results for a particular
1910.501(l)(1) of the ETS, availability of status or testing, as applicable, to the employee are included in this estimate
records, by the end of the next business employer. OSHA notes that, for an because this documentation will
day after a request, the employer must employee who is vaccinated, the normally be pulled from the electronic
make available, for examination and employer will determine the recordkeeping system described
copying, the individual COVID–19 vaccination status of that employees and above.50
vaccine documentation and any obtain acceptable proof of vaccination 50 The cost of providing to the Assistant Secretary
COVID–19 test results for a particular status at the same time, thus negating
for examination and copying the employer’s written
employee to that employee and to the need to create two separate records policy required by paragraph (d) of the ETS will be
anyone having written authorized for these requirements. de minimis.
App. 88
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61489
The total cost for these requirements • Total number of employees at • Total number of tests for employees
is calculated based on: covered firms getting vaccinated due to at covered firms who are unvaccinated
• One-time labor burden of 5 minutes the ETS with the Johnson & Johnson and will get vaccinated by receiving the
of employee labor to provide vaccine, who receive one shot. Pfizer and Moderna vaccines.
documentation and 5 minutes of clerk
• Total number of employees at • Total number of employees at
labor per employee record (one record
covered firms getting vaccinated due to covered firms who are unvaccinated and
per test administered and one record per
the ETS with the Pfizer-BioNTech and will be tested weekly.
documentation of vaccination status).
• The average labor rate for Office Moderna vaccines, multiplied by two to
account for two shots. Cost for Recordkeeping
Clerks, General (SOC 43–9060, NAICS-
specific wages) and employees • Total number of tests for employees Costs per entity and total costs for
providing documentation (average wage at covered firms who are unvaccinated recordkeeping are shown below in Table
over all employees, NAICS-specific and will get vaccinated by receiving the IV.B.12.
wages) Johnson and Johnson vaccine.
App. 89
61490 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61491
App. 91
61492 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
i. Summary of Total Cost
Total Cost and Total Cost per Entity
App. 92
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61493
App. 93
61494 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
j. Sensitivity Analysis Diagnostic Commons, October 6, 2021), has no historic reference on which to
As stated above, based on limited data OSHA estimates that 25 percent of firms base its assumptions regarding vaccine
on current vaccine mandate in scope currently have a vaccination mandates, the agency adjusted the
implementation and forecasts for future mandate, and assumes that this will rise percentage of firms that will institute a
implementation (Mishra and Hartstein, to 60 percent of covered employers after vaccine mandate because of the ETS as
August 23, 2021; ASU COVID–19 the ETS is in place. Because the agency part of a sensitivity analysis. Along with
App. 94
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61495
the baseline estimate of 60 percent of Compensation by Ownership, All 2018 corporations-covid-pandemic/. (Cerullo,
firms having a mandate, the agency Civilian Wages and Salaries, March August 31, 2021)
looked at a vaccine mandate rate of 40 2021. https://www.bls.gov/news.release/ Chesto J. (2021, June 22). Almost 40 percent
archives/ecec_06172021.pdf. (BLS, of remote workers in Mass. won’t be back
percent and 80 percent for covered in the office until January, at the earliest.
2021b)
firms, which OSHA judged to be a Bureau of Labor Statistics (BLS). (2021c). Boston Globe. https://
reasonable range based on the data Current Population Survey, Table 2. www.bostonglobe.com/2021/06/22/
available. The total costs associated Employed persons who teleworked or business/back-office-not-so-fast/.
with a 40 percent vaccine mandate are worked at home for pay at any time in (Chesto, June 22, 2021)
$2.998 billion, and the total costs the last 4 weeks because of the Chokshi N and Scheiber N. (2021, October 2).
associated with an 80 percent vaccine coronavirus pandemic by usual full- or Inside United Airlines’ Decision to
mandate are $2.964 billion. This part-time status, occupation, industry, Mandate Coronavirus Vaccines. The New
and class of worker; Persons who York Times. https://www.nytimes.com/
compares to the baseline costs 2021/10/02/business/united-airlines-
teleworked because of the coronavirus
associated with a 60 percent vaccine coronavirus-vaccine-mandate.html.
pandemic. https://www.bls.gov/cps/
mandate of $2.981 billion. A higher effects-of-the-coronavirus-covid-19- (Chokshi and Scheiber, October 2, 2021)
vaccine mandate increases the share of pandemic.htm#data. (BLS, 2021c) Courtney E. (2021, September 27). 30
employees who get vaccinated while Bureau of Labor Statistics (BLS). (2021d). Companies Switching to Long-Term
reducing the share that must get weekly Current Population Survey, Household Remote Work. flexjobs. https://
testing. It is this shift in shares that Data, Annual Averages, Employment www.flexjobs.com/blog/post/companies-
causes the costs to change because the status of the civilian noninstitutional switching-remote-work-long-term/.
population by age, sex, and race, Civilian Accessed September 27, 2021. (Courtney,
total costs associated with weekly September 27, 2021).
testing (recordkeeping) are more noninstitutional population. https://
www.bls.gov/cps/cpsaat03.htm. (BLS, Dingel J and Neiman B. (2020, July). How
expensive than the total costs associated 2021d) many jobs can be done at home? Journal
with vaccination under the ETS Bureau of Labor Statistics (BLS). (2021e). of Public Economics. Volume 189, July
(employer support for vaccination, National Compensation Survey: 2020, 104235. https://
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61496 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
#62: COVID–19 Vaccine Attitudes science/article/pii/S0264410X18306777? OSHA calculated the average
Among Healthcare Workers. The COVID via%3Dihub. (Putri et al., June 22, 2018) compounded annual rate of growth or
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19 mRNA vaccination, reactogenicity, survey-looks-at-vaccine-mandates-and- 100 or more employees in the 479
work-related absences and the impact on employee-turnover.html. (Umland, NAICS (out of 546) industries covered
operating room staffing: A cross- October 13, 2021) by this ETS for which Census data were
sectional study. https:// U.S. Census Bureau. (2019). Statistics of U.S. available and found that the average
www.ncbi.nlm.nih.gov/pmc/articles/ Businesses (SUSB). https:// annual real rate of change in revenues
PMC8479312/. (Levi et al., September 29, www.census.gov/programs-survey/ in absolute terms for the average firm
2021). susb.html. (U.S. Census Bureau, 2019)
Mishra D and Hartstein B. (2021, August 23). was 2.2 percentage points a year.51 In
U.S. Census Bureau. (2021). Household Pulse
Littler COVID–19 Vaccine Employer Survey (HPS), Week 37 Table 6A. other words, revenues are generally
Survey Report—Delta Variant Update. https://www.census.gov/programs- observed to change by well more than
https://www.littler.com/publication- surveys/household-pulse-survey/ one percent per year, on average, for
press/press/littler-survey-employers- data.html. (U.S. Census Bureau, 2021) firms with 100 or more employees in
increasingly-consider-vaccine-mandates- White C. (2021). Measuring Social and covered industries, indicating that
covid-19. (Mishra and Hartstein, August Externality Benefits of Influenza changes of this magnitude are normal in
23, 2021) Vaccination. Journal of Human
National Agricultural Statistics Service
these industries and that covered firms
Resources Vol 56 Number 3, pp. 749– are typically able to withstand such
(NASS). (2017). Census of Agriculture. 785. https://muse.jhu.edu/article/
https://www.nass.usda.gov/Quick_Stats/ 798143. (White, 2021) changes over the course of a year, much
CDQT/chapter/1/table/1. (NASS, 2017) Willis Towers Watson. (2021, June 23). less six months. As discussed below, the
O’Sullivan J. (2021, September 18). COVID–19 Vaccination and Reopening average percentage change due to this
Washington state workers are getting the Workplace Survey. https:// ETS for all covered NAICS is a fraction
exemptions to avoid the COVID–19 www.willistowerswatson.com/en-US/ of this fluctuation in revenues.
vaccine—but will they keep their jobs? Insights/2021/06/covid-19-vaccination-
Seattle Times. https:// and-reopening-the-workplace-survey.
The second screening test that OSHA
www.seattletimes.com/seattle-news/ (Willis Towers Watson, June 23, 2021) traditionally uses to consider whether a
politics/washington-state-workers-are- standard is economically feasible for an
getting-exemptions-to-avoid-the-covid- V. ETS Economic Feasibility affected industry is if the costs of
19-vaccine-but-will-they-keep-their-jobs/. Determination compliance are less than ten percent of
(O’Sullivan, September 18, 2021). annual profits (see, e.g., OSHA’s
Occupational Safety and Health a. OSHA’s Screening Tests for Economic
Feasibility economic analysis of its Silica standard,
Administration (OSHA). (2021,
September 25). State Plans. https:// 81 FR 16286, 16533 (March 25, 2016);
As noted in the introduction to the upheld in N. Am.’s Bldg. Trades Unions
www.osha.gov/stateplans/faqs. (OSHA, economic analysis, an OSHA standard is
September 25, 2021) v. OSHA, 878 F.3d 271, 300 (D.C. Cir.
economically feasible when industries
Occupational Safety and Health 2017)). The ten-percent profit test is also
can absorb or pass on the costs of
Administration (OSHA). (2021a, intended to be at a sufficiently low level
October). Analytical Spreadsheets in compliance without threatening
so as to allow OSHA to identify
Support of the COVID–19 Vaccination industry’s long-term profitability or
industries that might require further
and Testing ETS. (OSHA, October 2021a) competitive structure, Cotton Dust, 452
examination. Specifically, the profit
Occupational Safety and Health U.S. at 530 n.55, or ‘‘threaten[ing]
Administration (OSHA). (2021b, screen is primarily used to alert OSHA
massive dislocation to, or imperil[ing]
October). COVID–19 Vaccination and to potential impacts on industries where
the existence of, the industry.’’ United
Testing ETS: Economic Profile and Cost the price elasticity of demand does not
Steelworkers of Am. v. Marshall (Lead
Chapter Appendices. (OSHA, October allow for ready absorption of new costs
I), 647 F.2d 1189, 1272 (D.C. Cir. 1981).
2021b) in higher prices (e.g., industries with
Occupational Safety and Health To determine whether a rule is
economically feasible, OSHA typically foreign competition where the American
Administration (OSHA). (2021c, firms would incur costs that their
October). Health Impacts of the COVID– begins by using two screening tests to
determine whether the costs of the rule foreign competitors would not because
19 Vaccination and Testing ETS. (OSHA,
October 2021c) are beneath the threshold level at which they are not subject to OSHA
Occupational Safety and Health the economic feasibility of an affected requirements). In addition, setting the
Administration (OSHA). (2021d, industry might be threatened. The first threshold for the profit test low permits
October). Costs Associated with screening test is a revenue test. While OSHA to reasonably conclude that the
Reasonable Accommodation: Testing,
there is no hard and fast rule on which rule would be economically feasible for
Face Coverings, and Determinations. industries below the threshold. To put
(OSHA, October 2021d) to base the threshold, OSHA generally
considers a standard to be economically the ten-percent profit threshold test into
Portnoy J. (2021, October, 3). Several perspective, evidence used by OSHA in
hundred Virginia health-care workers feasible for an affected industry when
have been suspended or fired over the annualized costs of compliance are its 2016 OSHA silica rule indicates that,
coronavirus vaccine mandates. The less than one percent of annual for the combined affected
Washington Post. https:// revenues. The one-percent revenue manufacturing industries in general
www.washingtonpost.com/local/covid- threshold is intentionally set at a low industry and maritime from 2000
vaccine-mandate-hospitals-virginia/ level so that OSHA can confidently through 2012, the average year-to-year
2021/10/01/b7976d16-21ff-11ec-8200-
assert that the rule is economically fluctuation in profit rates (both up and
5e3fd4c49f5e_story.html. (Portnoy,
October 3, 2021) feasible for industries that are below the
51 These results are presented in the Excel ETS
Putri W et al. (2018, June, 22). Economic threshold (i.e., industries for which the
Revenue Threshold Test Tables available in the
burden of seasonal influenza in the costs of compliance are less than one Docket for this ETS. The data used for six-digit
United States. Vaccine 36(27), 3960– percent of annual revenues). To put the NAICS were from the Bureau of the Census,
3966. https://www.sciencedirect.com/ one-percent threshold into perspective, available every five years (2002, 2007, 2012, 2107).
App. 96
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61497
down) was 138.5 percent (81 FR to marshal revenue and minimize Book (IRS, 2013). The IRS discontinued
16545).52 impacts on reserves). the publication of these data after 2013,
When an industry ‘‘passes’’ both the The compliance costs for this ETS are and therefore the most current years
‘‘cost-to-revenue’’ and ‘‘cost-to-profit’’ for a temporary rule for a period of six available are 2000–2013.54 The most
screening tests, OSHA is assured that months (which, again, is the time period recent version of the Source Book
the costs of compliance with the rule are that OSHA assumes this ETS will last, represents the best available evidence
economically feasible for that industry. solely for economic purposes). While for these data on profit rates.55
The vast majority of the industries OSHA believes the most appropriate For each of the years 2000 through
covered by the ETS fall into this screens would be based on annual 2013, OSHA calculated profit rates by
category. profits and revenue, it has followed the dividing the ‘‘net income’’ from all firms
A rule is not necessarily economically more cautious route of basing the (both profitable and unprofitable) by
infeasible, however, for the industries screens on 6 months of profits and total receipts from all firms (both
that do not pass the initial revenue revenues to avoid any potential profitable and unprofitable) for each
screening test (i.e., those for which the uncertainty about whether the ETS is NAICS.56 OSHA then averaged these
costs of compliance with the rule are economically feasible for the industries rates across the 14-year (2000 through
one percent or more of annual covered by this ETS. Using one year of 2013) period. Since some data provided
revenues), the initial profit screening revenues and profits as the by the IRS were not available at
test (i.e, those for which the costs of denominators in the cost-to-revenue and disaggregated levels for all industries
compliance are ten percent or more of cost-to-profit ratios would have resulted and profit rates, data at more highly
annual profits), or both. Instead, OSHA in ratios that are half of the estimated aggregated levels were used for some
normally views those industries as ratios presented in this analysis. It is industries; that is, where data were not
requiring additional examination as to therefore unsurprising that businesses available for each six-digit NAICS code,
whether the rule would be economically in some number of NAICs have edged data for the corresponding four- or five-
feasible (see N. Am.’s Bldg. Trades above the profit-thresholds using a 6
digit NAICS codes were used. Data were
Unions v. OSHA, 878 F.3d at 291). month screen (as will be discussed
used for all firms in the NAICS (as
OSHA therefore conducts further later), and OSHA believes that edging
opposed to just firms with 100 or more
analysis of the industries that ‘‘fail’’ one above the screening thresholds is less of
employees) since data disaggregated by
or both of the screening tests in order to an indicator of economic peril in this
employment size-class were not
evaluate whether the rule would context than in the context of a
available. Profit rates are expressed as a
threaten the existence or competitive permanent rulemaking analysis.
percentage (see OSHA, October 2021a).
structure of those industries (see United Nevertheless, OSHA has examined each
Profits themselves were used to
Steelworkers of Am., AFL–CIO–CLC v. of the NAICS that did not clear either of
calculate the cost-to-profit estimates for
Marshall, 647 F.2d 1189, 1272 (D.C. Cir. these conservative screening tests and
has concluded that the ETS is all firms contained in a particular
1980)). NAICS code (see OSHA, October 2021a).
economically feasible for each one.
Time Parameters for Analysis OSHA has estimated costs over a 6-
Data Used for the Screening Tests month timeframe for this ETS. As
OSHA’s economic analyses almost discussed above, OSHA has therefore
The estimated costs of complying
always measure the costs of a standard used six months of revenue to conduct
with the ETS, which OSHA relied upon
on an annual basis, conducting the the cost-to-revenue tests and six months
to examine feasibility is based on the
screening tests by measuring the cost of of profit to conduct the cost-to-profit
two tests described above (see OSHA,
the standard against the annual profits October 2021a). The revenue numbers tests.
and annual revenues for a given used to determine cost-to-revenue ratios
industry. One year is typically the General Use of Revenues and Profits To
were obtained from the 2017 Economic
minimum period for evaluating the Measure Economic Feasibility
Census for firms with 100 or more
status of a business; for example, most employees in covered industries. This is As with other OSHA rulemaking
business filings for tax or financial the most current information available efforts, the agency relies on the two
purposes are annual in nature. from this source, which OSHA screening tests (costs less than one
Some compliance costs are up-front considers to be the best available source percent of revenue and costs less than
costs and others are spread over the of revenue data for U.S. businesses.53 ten percent of profit) as an initial
duration of the ETS; regardless, the OSHA adjusted these figures to 2020 indicator of economic feasibility. OSHA
costs of the rule overall will not dollars using the Bureau of Economic has generally found that the cost-to-
typically be incurred or absorbed by Analysis’s GDP deflator, which is revenue test is a more reliable indicator
businesses all at once. However, OSHA OSHA’s standard source for inflation of feasibility simply because the
does not expect that the ETS will and deflation analysis. revenue data are more accurate than the
require employers to incur initial capital The profit screening test for feasibility profit data. There are several reasons for
costs for equipment to be used over (i.e., the cost-to-profit ratio) was this.
many years (which would typically be calculated as ETS costs divided by
addressed through installments over a First, OSHA has been using corporate
profits. Profits were calculated as profit balance sheet data from the IRS as the
year or a longer period to leverage loans rates multiplied by revenues. The
or payment options to allow more time best available evidence for estimating
before-tax profit rates that OSHA used
were estimated using corporate balance 54 See IRS, 2013.
52 Profits are subject to the dynamics of the
sheet data from the Internal Revenue 55 OSHA also investigated Bizminer and RMA as
overall economy. Many factors, including a national
or global recession, a downturn in a particular Service (IRS), 2013 Corporation Source potential sources of profit information and
industry, foreign competition, or the increased determined that they do not represent adequate and
competitiveness of producers of close domestic 53 For information regarding the standards and random samples of the affected industries.
substitutes are all easily capable of causing a practices used by the Census Bureau to ensure the 56 There is one code reported per tax entity and
decline in profit rates in an industry of well in quality and integrity of its data, see (US Census it may not be representative to the six-digit level.
excess of ten percent in one year or for several years Bureau, October 8, 2021a; US Census Bureau, See Corporation Sourcebook on limitations of the
in succession (See OSHA, March 24, 2016). October 8, 2021b). industry classification for details. (IRS, 2013).
App. 97
61498 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
corporate profits for years.57 tax-related incentives, as previously larger the decrease in the quantity
Nevertheless, because firms typically noted. demanded for a product when the price
have an incentive to minimize their tax Whatever the reason, the cost-to-profit goes up. When demand is elastic,
burden, it is reasonable to expect that calculations for NAICS with negative establishments have less ability to pass
some of the reported accounting data profit rates fail to provide reliable compliance costs on to customers in the
may have been strategically adjusted to information about the long-term form of a price increase and must absorb
reduce reported profits and their profitability of these industries, such costs in the form of reduced
associated tax implications. Business independent of the ETS. Companies and profits. In contrast, when demand is
profits are much more likely to reflect industries that consistently lose money relatively inelastic, the quantity
such strategic accounting than business do not typically stay in business, and demanded for the product or service
revenues; accordingly, revenues are a would almost certainly not still be in will be less affected by a change in
more accurate measure than profits for business in 2021 if that loss continued price. In such cases, establishments can
evaluating economic feasibility for a at the same level for each of the 8 years recover most of the variable costs of
multitude of reasons.58 since the profit data was published in compliance (i.e., costs that are highly
2012. Revenue streams are a more correlated with the amount of output)
Second, because OSHA is using data dependable measure for those firms by raising the prices they charge; under
from both profitable and unprofitable because those streams tend to be more this scenario, if costs are variable rather
firms, the average profit rate for a small stable and more indicative of the actual than fixed, business activity and profit
number of industries is negative (as capabilities of sustainable firms than rates are largely unchanged for small
described above, using 14 years of data reported negative profit margins. As a changes in costs. Ultimately, where
that predate the pandemic). This result result, for the purposes of this analysis, demand is relatively inelastic, any
could have occurred because of the way OSHA has relied more heavily on its impacts are primarily borne by those
profits are calculated, which cost-to-revenue estimates, in lieu of customers who purchase the relevant
unnaturally skews average profit rates cost-to-profit estimates, as the more product or service for a slightly higher
downward by including firms that have reliable indicator for economic price. Most of the costs of this ETS are
large losses (negative profits) or feasibility for the industries with variable costs because they depend
subnormal profits and have already negative profit rates. primarily on the level of production or
closed or are in the process of closing, Third, and similarly, profit rates that the number of employees at an
irrespective of any action by OSHA. The are only slightly positive (i.e., less than establishment. For example, under the
negative rates could also be the result of one percent) are inconclusive and not ETS, a firm with 500 employees must
macroeconomic fluctuations during the useful for the purpose of OSHA’s cost- determine and record the vaccination
14-year period used to determine the to-profit test. In economics terms, profit status of 500 employees, while a firm
average, a period in which some of these entails a reasonable rate of return on
with 250 employees need determine and
industries may have experienced investment, and long-term profits of less
record the vaccination status of only 250
unusually adverse financial impacts than one percent a year are not generally
employees.59
(see, e.g., the explanation in Chapter VI, reasonable for firms that expect to
In general, ‘‘[w]hen an industry is
pp. VI–20 of the Final Economic and remain in business. Thus data showing
subjected to a higher cost, it does not
Regulatory Flexibility Analysis for industry-wide profits in this range do
simply swallow it; it raises its price and
OSHA’s Rule on Occupational Exposure not measure the true ability of
reduces its output, and in this way
to Respirable Crystalline Silica, Docket companies to pay for the ETS costs. As
shifts a part of the cost to its consumers
No. OSHA–2010–0034–4247, which previously stated, revenue streams tend
to be more stable and more indicative of and a part to its suppliers’’ (Am. Dental
notes the skew from negative impacts Ass’n v. Sec’y of Labor, 984 F.2d 823,
during recession years (OSHA, March the actual capabilities of sustainable
firms. Therefore, where possible, OSHA 829 (7th Cir. 1993)). A reduction in
24, 2016)). Or they could result from output could happen in a variety of
prefers to rely on the cost-to-revenue
test to evaluate economic feasibility for ways: Individual establishments could
57 OSHA funded and accepted a final report by
industries that have a less than one reduce their levels of service (e.g., retail
Contractor Henry Beale (Beale Report, 2003) that
reviewed alternative financial data sources and percent profit rate. firms) or production (e.g.,
concluded that the IRS data were the best. Since The qualification, and by far the most manufacturing), both of which could
then OSHA has been relying on IRS data to provide
important reason for the general take the form of a reduction of worker
the financial data to support its rulemaking hours; some marginal establishments
analyses. See, for example, Occupational Safety and primacy of revenues versus profits as
Health Administration (OSHA) (2016), Final the appropriate metric for determining could close; or, in the case of an
Economic and Regulatory Flexibility Analysis for economic feasibility, for most OSHA industry with high turnover of
OSHA’s Rule on Occupational Exposure to
rules, is that the regulated firms are able establishments, new entry could be
Respirable Crystalline Silica, Chapter VI, pp. VI–2 delayed until demand equals supply. In
to VI–3, Docket No. OSHA–2010–0034–4247 to pass on the costs of the rule in the
(OSHA, March 24, 2016), which includes a more form of higher prices. When they many cases, a decrease in overall output
recent review of data sources for corporate financial cannot, the profit test functions for an industry will be a combination of
profit data and further support for OSHA’s choice
primarily as a screen for a limited all three kinds of reductions. The
of IRS data. primary means of achieving the
58 In fact, all other Department of Labor agencies purpose: Alerting OSHA to potential
rely solely on revenues to assess economic impacts, impacts where unregulated competitors reduction in output most likely depends
such as Regulatory Flexibility Act certifications, in can prevent firms from passing costs on the rate of turnover in the industry
their rulemakings (see, e.g., Employment and along to customers. and on the form that the costs of the
Training Administration, Final Rule on regulation take. Further, the temporary
Strengthening Wage Protections for the Temporary
To understand this point, some
and Permanent Employment of Certain Aliens in economic background is needed. The nature of the ETS and its associated
the United States, https://www.govinfo.gov/content/ price elasticity of demand refers to the
pkg/FR-2021-01-14/pdf/2021-00218.pdf; Wage and 59 While fixed cost can be more limiting in terms
relationship between the price charged
Hour Division, Tip Regulations Under the Fair of options for businesses, most of the costs of this
Labor Standards Act (FLSA), https://
for a product or service and the quantity rule are not fixed. Instead, most of the compliance
www.govinfo.gov/content/pkg/FR-2020-12-30/pdf/ demanded for that product or service: costs vary with the level of output or employment
2020-28555.pdf). The more elastic the relationship, the at a facility.
App. 98
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61499
costs suggests that firms may have more covered by the ETS as soon as they ten percent of profit) as an initial
flexibility to respond than when facing reached 100 employees.60 indicator of economic feasibility. In this
a permanent increase in costs. For 2. An important factor to consider in section, OSHA discusses the industries
example, firms may be able to calculating the costs and impacts and that fall above the threshold level for
temporarily increase prices or economic feasibility of this ETS is the either screening test.
temporarily defer planned capital unquantified and unmonetized cost The overall effect of compliance with
expenditures or other maintenance to savings and other positive economic the general section of the ETS on
cover compliance costs. impacts accruing to employers that covered industries is very small (see
comply with the ETS. These include OSHA, October 2021a). The vast
There are two situations typically reduced absenteeism due to COVID–19 majority of the covered NAICS have
mentioned when an industry subject to illnesses 61 and quarantine.62 Other very low cost-to-revenue and cost-to-
regulatory costs might be unable to pass positive economic impacts that profit ratios, with the overall averages
those costs on: (1) Foreign competition compliant employers would enjoy from being 0.02 percent of revenues and 0.49
not subject to the regulation, or (2) a safer business environment are percent of profits. To put this into
domestic competitors in other increased retail trade from customers perspective, if the average firm decided
industries, not subject to the regulation, that feel less at risk and better relations to raise prices to cover the costs of the
that produce goods or services that are with suppliers and other business ETS, the price of a $100 product or
close substitutes. Otherwise, when all partners. These all would contribute to service, for example, would have to be
affected domestic industries are covered improved business and increased increased by 2 cents (during the six-
by a rule and foreign businesses must profits. month period).
also comply with the rule or are unable 3. The existence of these cost savings
and other positive economic impacts Based on the information presented
to compete effectively, the ability of a here, the costs of the ETS are below both
accruing to employers that comply with
competing industry to offer a substitute the threshold revenue test (1 percent of
the ETS suggests that the actual net
product or service at a lower price is revenues) and the threshold profit test
costs of the ETS will be much lower
greatly diminished. than the costs reported in the (10 percent of profits) for the vast
There is a third situation that is supporting economic analysis for this majority of NAICS industries.63 This
relevant to this ETS—when only some ETS used to estimate cost impacts and indicates that the average firm in these
firms in a domestic industry (in this demonstrate economic feasibility. In industries will be able either to raise
case, only employers with 100 or more fact, for some share of covered prices to cover ETS costs or to absorb
employees) are subject to the ETS and employers, the net costs of the ETS may the costs of the ETS out of available
its regulatory costs. In principle, well be negative. Indeed, this is being profits. In either case, OSHA concludes
confirmed by revealed preference in the that the ETS is economically feasible for
competition from smaller employers in
market. Elsewhere in the economic all of these industries.
a NAICS could prevent the larger
employers from passing on their costs in analysis for this ETS (Cost Analysis Critically, there are no industries
the form of higher prices and instead section 4.2), OSHA has provided covered by the general section of the
evidence to support its estimate that 25 ETS that are above OSHA’s cost-to-
require them to absorb the costs in the
percent of covered employers already revenue threshold level of one percent
form of lost profits. There are, however,
voluntarily require that their employees and most are a small fraction of this
several important caveats: level. Because OSHA is using data from
be vaccinated and a much larger
1. As a practical matter, it is percentage are considering a vaccine both profitable and unprofitable firms,
implausible to expect that covered mandate. This strongly supports the the average profit rate for a small
employers (with 100 or more conclusion that these businesses agree number of industries is negative. There
employees) would feel constrained by that doing so will ultimately save costs. are 14 NAICS with negative cost-to-
smaller competitors in their industry so profit ratios, resulting from negative
as not to pass on costs for a rule lasting b. Economic Feasibility Analysis and average profit rates. These industries
6 months that imposes costs equal to Determination with negative profit rates are domestic
0.02 percent of revenues, on average This section summarizes OSHA’s service industries that are not subject to
across all NAICS, over that time period feasibility findings for industries international competition.
(see OSHA, October 2021a). This time covered by the ETS. As stated There are eight six-digit NAICS
period would likely be too short for previously, the agency uses two industries, covering all establishments
small firms to expand to take business screening tests (costs less than one in those industries covered by the
away from the larger firms or for new percent of revenue and costs less than general section of the ETS, with cost-to-
firms to form to take advantage of such profit ratios above 10 percent:
60 This cost advantage may be exaggerated or non-
minor and transitory business 1. NAICS 221118—Other Electric
existent in many cases (see the discussion directly
opportunities. Furthermore, smaller below in the text in Caveat 2). Power Generation, 23.97 percent;
firms (particularly very small firms— 61 Several occupational groups less able to avoid 2. NAICS 488119—Other Airport
those with fewer than 20 employees) exposure to SARS–CoV–2 infection exhibited Operations, 18.41 percent;
significantly higher rates of absenteeism in March–
typically can’t compete on price with April 2020 compared to earlier periods 3. NAICS 488410—Motor Vehicle
large firms that have cost advantages (Groenewold et al., July 10, 2020). Towing, 15.75 percent;
due to various economies of scale; as a 62 For a discussion of turnover (i.e. whether the
4. NAICS 488490—Other Support
ETS could affect the likelihood that an employee
result, smaller firms often serve a will remain with an employer, either because the
Activities for Road Transportation,
specialized niche market rather than imposition of a vaccine requirement will lead some 14.32 percent;
compete directly with larger firms. To employees to leave and find employment at an 5. NAICS 713920—Skiing Facilities,
the extent that this ETS creates new establishment not subject to the ETS, or, 13.16 percent; and
alternatively, to stay due to a preference for
business opportunities for these smaller enhanced COVID–19 safety procedures), please see
uncovered firms, they would also be the cost section (Section III.d.) of this economic 63 By OSHA’s calculation, 524 out of the 546 six-
analysis. digit NAICS covered by the ETS.
App. 99
61500 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
6. NAICS 713940—Fitness and employees can take away significant employers with 100 or more employees
Recreational Sports Centers, 12.33 portions of business from the larger will somehow put these larger firms in
percent; firms without becoming subject to the economic jeopardy from the smaller
7. NAICS 713120—Amusement requirements of the rule themselves. If firms to which the ETS does not
Arcades, 11.18 percent; and the larger firms do not feel threatened currently apply. This is highly
8. NAICS 488320—Marine Cargo by being underpriced by smaller firms improbable for several reasons
Handling, 10.03 percent. in these NAICS industries, then they discussed earlier, including the fact that
The average profit rate reported over could raise prices an average of less these are large employers with
the 14 years for which OSHA has profit than 0.05 percent 64 to cover the cost of advantages of economies of scale and
data for all the NAICS affected by the the ETS—a small fraction of the 1.0 access to capital and the fact that this is
ETS is 4.2 percent. All of the eight percent of revenues threshold (beneath a temporary standard that would result,
NAICS industries with a cost-to-profit which OSHA has determined that at most, in marginal impacts over 6
ratio above the 10 percent threshold economic feasibility is not a concern). months (on average, equal to costs of
report an annual profit rate below one 3. These firms must not generate 0.02 percent of revenues, which, again,
percent—75 percent or more below the sufficient profits or have adequate translates to a cost increase of a penny
overall average for all NAICS covered by borrowing capacity during the six on a fifty dollar item).
the ETS. These eight industries all months the ETS is in force to cover the But even that misses the main point:
provide domestic services and are not costs of the ETS. There are several Economic feasibility refers to the
subject to international competition. reasons to doubt that this condition industry, not to the firm. OSHA must
The fact that the covered firms in broadly applies. First, the estimates of construct a reasonable estimate of
these 22 NAICS industries (the 14 with business profits come from corporate compliance costs and demonstrate a
negative cost-to-profit ratios and the 8 balance sheet data that firms report to reasonable likelihood that these costs
with more sustainable cost-to-profit the IRS. But, as previously noted, it is will not threaten the existence or
ratios) exceeded the profit screen generally the case that firms have an competitive structure of an industry,
suggests that they might in theory have incentive to minimize their tax burden, even if it does portend disaster for some
difficulty paying for the costs of the ETS and it is reasonable to expect that some marginal firms (Lead I, 647 F.2d at
out of profits gained over the six-month of the reported accounting data may 1272). In the (again) highly unlikely
duration of the ETS if they had no have been strategically adjusted to event that individual firms exit an
savings or access to capital, but even if reduce reported profits and their industry and are replaced by other firms
that were true it would be highly associated tax implications. Another in the industry, then the ETS would
unlikely to place the firms in financial point concerning the IRS data is that preserve the economic feasibility of the
jeopardy. OSHA examines these they include the negative profits of covered industries. If an employer
industries more closely below, but firms that are going out of business or covered by this standard actually had to
before even considering the reasons in have since gone out of business. To the increase its prices slightly to account for
NAICs-specific analysis it is important extent that these points are true, many the cost of this standard, there are two
to consider the larger context. For the or most of the covered firms in these potential groups of smaller businesses
ETS to threaten the economic solvency NAICS industries (still in business) that could seek to supplant the covered
of these firms, the following 3 actually would generate sufficient profit firms. The first group of businesses are
conditions must apply: to cover the cost of the ETS. A related much smaller than the covered firms.
1. These firms must not enjoy certain point is that for this condition to apply, Those businesses, however, will
cost savings and positive economic the firms must not be able to borrow the typically have higher costs and prices to
impacts from the ETS that would money to pay for the costs of the ETS. begin with due to their scale
partially or totally offset their costs. Recall, however, that these are all large disadvantages to the larger firms. The
This condition is questionable because firms with 100+ employees. It is larger firm’s small price increases
of the estimated 25 percent of employers reasonable to expect that many or most attributable to this ETS would not be
sampled that reported voluntarily firms of this size in the 22 NAICS likely to create an actionable
imposing a vaccine mandate and the industries at issue either have available competitive advantage for this group of
substantial number more contemplating funds or could obtain a short-term loan smaller businesses. The second group of
the voluntary adoption of such a to cover costs equal to the 0.01 to 0.11 businesses are those closer in size to the
mandate. They can be expected to base percent of revenues that these firms 100-employee cutoff. If the marginal
their decisions, partly or entirely, on would incur over the six-month period price increases did actually cause some
anticipated cost savings or positive that OSHA assumes the ETS will remain of the larger firms to fail and the slightly
economic impacts (which would reduce in effect. Firms of this size normally smaller firms to take their place, the
or eliminate their risk of insolvency due have banking relationships and some industry itself would not suffer a
to the ETS). unencumbered assets. They also have massive dislocation or be imperiled.
2. These firms (all with 100 or more And, of course, if all of the firms in an
access to national and international
employees) must not be able to raise industry are large employers with 100 or
capital markets. If these firms can
prices to cover ETS costs because of the more employees, no competitive
borrow funds to pay for the ETS, then
threat that smaller firms in their NAICS disadvantage from within the industry
the profit restriction doesn’t matter.
industry, not covered by the ETS, could Finally, OSHA anticipates concern would exist (even hypothetically), and
underprice them and take away their that limiting the scope of the ETS to there would be no question that they
business. This condition is unlikely or could cover the cost of ETS by raising
limited because of the economies of 64 If not underpriced by smaller firms, covered prices to customers accordingly.
scale the larger firms enjoy and the fact firms in the 8 NAICS industries reporting ETS costs Although the preceding discussion
that the smaller firms out of necessity above 10 percent of profits could cover these costs demonstrates that the ETS is
tend to serve a market niche not in by raising prices an average of 0.08 percent (highest, economically feasible, OSHA has
0.11 percent); covered firms in the 14 NAICS
direct competition with the larger firms. industries reporting negative profits could cover
provided an additional examination of
Also, there is a severe limit to the extent ETS costs with a price increase of 0.01 percent each of the NAICS that have crossed the
that firms with fewer than 100 (highest, 0.02 percent). profit screen (again noting that none of
App. 100
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61501
these failed the revenue screen): The investment phase of the business, where services are geographically based, there
eight NAICS industries with positive short-term losses are expected and offset is no risk of international competition.
profit ratios but profit rates below 1 with the anticipation of enormous
4. NAICS 488490—Other Support
percent. revenue growth potential (in an
Activities for Road Transportation,
acknowledged very limited energy
1. NAICS 221118—Other Electric Power 14.32 Percent 68
market.) Given these factors, OSHA’s
Generation, 23.97 Percent
typical revenue and profit screen are a This industry offers services that must
This U.S. industry comprises poor predictor of future viability with be done to ensure proper operation of
establishments primarily engaged in respect to this NAICS industry roadways (for example, bridge, tunnel,
operating electric power generation (although, as pointed out, this NAICS and highway operations, pilot car
facilities (except hydroelectric, fossil industry, like all other NAICS services (i.e., wide load warning
fuel, nuclear, solar, wind, geothermal, industries, falls well below the revenue services), driving services (e.g.,
biomass). These facilities convert other screen threshold). The estimated cost of automobile, truck delivery), and truck or
forms of energy, such as tidal power, this ETS per firm is $866 in this NAICS weighing station operations), thus
into electric energy. The electric energy industry, which equals about 11 cents negating the potential for substitution.
produced in these establishments is per hundred dollars of revenue over a In addition, because these services need
provided to electric power transmission limited six-month duration. OSHA to be done in particular domestic
systems or to electric power distribution concludes that this industry will be able locations (i.e., roadways), there is no
systems. to withstand this small cost in order to risk of international competition.
Using tides to generate power is not keep its workers protected during the
yet economically viable, according to pandemic. 5. NAICS 713920—Skiing Facilities,
one source, because ‘‘[t]otal availability 13.16 Percent 69
of tidal power is restricted by its 2. NAICS 488119—Other Airport
Operations, 18.41 Percent 66 This industry caters to a wealthy
relatively high cost and limited number
clientele who ensure an inelastic
of sites having high flow velocities and The services this industry offers are demand easily capable of absorbing any
tidal ranges,’’ although ‘‘with [ ] recent integrated into a particular geographic fractional increases attributable to this
advancements in tidal technologies, the location and entail specific tasks, such ETS.70 In addition, skiing is done
total availability of tidal power in terms as parking and baggage handling outdoors, which will incentivize
of turbine technology as well as design services, that must be done to ensure the clientele to continue engaging in this
may be higher than before, and the proper functioning of airports, thus
particular activity in lieu of indoor
economic costs may be reduced negating the potential for substitution
substitutions, during the pandemic.
significantly to competitive levels.’’ In during the 6 month period that OSHA
support, in the same article, ‘‘recent Finally, there is little to no risk of
is assuming the ETS will be in effect for
reports state that the UK, which has the international competition from foreign
economic purposes. In addition,
largest tidal and wave resource in ski resorts because the added and
because these are services that need to
Europe, is capable of harnessing up to substantial costs of international travel
be done in particular domestic locations
153GW of tidal power capacity with the outweigh the costs associated with
(i.e., airports), there is no risk of
help of three types of technologies and marginally higher prices resulting from
international competition.
thus meeting 20% of current UK the ETS.
3. NAICS 488410—Motor Vehicle
electricity demand and reducing carbon 6. NAICS 713940—Fitness and
Towing, 15.75 Percent 67
emissions. Hence it is evident that wave Recreational Sports Centers, 12.33
and tidal energy could contribute more The actual cost impacts on this Percent 71
to the increasing electricity demands industry are likely significantly
across the globe.’’ 65 overstated to the extent that most As these settings are generally located
At the time OSHA obtained the most employees performing towing services close to where clients live or work, there
recent NAICS data, there were 7 affected ride alone in their trucks and their is no risk of international competition.
entities in this NAICS industry. The services do not typically require Some of the largest employers in this
entities in this NAICS industry include exposure to others. In the event that industry have already responded to
firms like Berkshire Hathaway Energy individual large towing firms are customer feedback by not only requiring
Company, (with annual sales of $19.8 concerned about economic impacts, it employees to be vaccinated, but also
billion, whose ‘‘portfolio consists of would not be difficult to structure their
locally managed business that share a employee interactions with the 68 This industry comprises establishments
company and customers to take primarily engaged in providing services (except
vision for a secure and sustainable motor vehicle towing) to road network users.
energy future’’); Dominion Energy (with advantage of the scope restrictions. 69 This industry comprises establishments
annual sales of $13.4 billion); and other Moreover, the primary services this engaged in (1) operating downhill, cross country, or
leading firms in this industry including industry offers involve the use of related skiing areas and/or (2) operating equipment,
some of the largest power generation specialized vehicles designed uniquely such as ski lifts and tows. These establishments
often provide food and beverage services,
companies in the US (See NAICS for towing, thus lowering the risk of equipment rental services, and ski instruction
Association, 2018a; NAICS Association substitution. In addition, because these services. Four season resorts without
2018d; and NAICS Association 2018e). accommodations are included in this industry.
As this NAICS industry is not yet 66 This U.S. industry comprises establishments 70 See Brown, January 19, 2017, ‘‘[o]f the 9.4
primarily engaged in (1) operating international, million skiers in the U.S., more than half earn a
viable, (in the United States, at least), it national, or regional airports, or public flying fields salary higher than $100,000. For some context, only
is to be expected that revenues and or (2) supporting airport operations, such as rental 20 percent of American households have a
profits would be low. In fact, OSHA of hangar space, and providing baggage handling combined income of $100K. . . .’’)
believes the best way to view this and/or cargo handling services. 71 This industry comprises establishments
67 This industry comprises establishments primarily engaged in operating fitness and
industry is as a series of incredibly well-
primarily engaged in towing light or heavy motor recreational sports facilities featuring exercise and
funded start-up companies during the vehicles, both local and long-distance. These other active physical fitness conditioning or
establishments may provide incidental services, recreational sports activities, such as swimming,
65 See Walker, January 22, 2013. such as storage and emergency road repair services. skating, or racquet sports.
App. 101
61502 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
members.72 This suggests both that the (Scheduled Freight Air Transportation), routes to take advantage of the 100-
costs estimates attributed to the ETS are NAICS 481211 (Nonscheduled employee cutoff in the ETS in the 6-
overstated for these employers because Chartered Passenger Air months the ETS is assumed to be in
higher levels of compliance may have Transportation), NAICS 481212 effect.
already occurred than projected in (Nonscheduled Chartered Freight Air
2. Telecommunications 76
OSHA’s analysis, and that the ETS Transportation), NAICS 481219 (Other
requirements reflect more of an industry Nonscheduled Air Transportation). NAICS 517311 (Wired
trend than a threat to the existence of This group of NAICS industries is Telecommunications Carriers), NAICS
the industry. comprised of U.S. industries that 517312 (Wireless Telecommunications
primarily engage in providing air Carriers (except Satellite), NAICS
7. NAICS 713120—Amusement transportation. There is little to no risk 517410 (Satellite Telecommunications),
Arcades, 11.18 Percent 73 of substitution for this group of NAICS NAICS 517911 (Telecommunications
This industry caters to a select industries. Air transportation provides Resellers), NAICS 517919 (All Other
clientele who have chosen to engage in unique and important benefits that Telecommunications).
leisure activities in the unique settings cannot be substituted via other forms of This group of NAICS industries is
offered by the industry, thus negating transportation (e.g., rail, freight, bus). entirely comprised of U.S. industries,
the likelihood for substitution. In (See ATAG, September 2005). To this except for NAICS 517410 (Satellite
addition, because these settings are end, air transportation is often the Telecommunications). All of these
localized, there is no risk of speediest means of transporting industries provide specialized unique
international competition. passengers and cargo, giving it a unique services in the telecommunications
purpose that cannot be met by other industry that require specialized unique
8. NAICS 488320—Marine Cargo forms of transport. It should be noted knowledge and are thus resistant to
Handling, 10.03 Percent 74 that the five NAICS in this group of substitution. While it is perhaps
The services this industry offers are industries are the only NAICS in NAICS
76 NAICS 517311 (Wired Telecommunications
integrated into a particular location and 4811 (Scheduled Air Transportation)
Carriers) comprises establishments primarily
entail specific tasks, such as loading and and 4812 (Nonscheduled Air engaged in operating and/or providing access to
unloading services at ports and harbors, Transportation). The other industries in transmission facilities and infrastructure that they
longshoremen services, marine cargo NAICS 48 (Transportation) do not own and/or lease for the transmission of voice, data,
handling services, ship hold cleaning provide air transportation (See NAICS text, sound, and video using wired
telecommunications networks. Establishments in
services, and stevedoring services, that Association, 2018b). This further this industry use the wired telecommunications
must be done to ensure the proper reduces the risk of substitution, as all network facilities that they operate to provide a
movement of cargo off of and onto five NAICS at issue have a negative variety of services, such as wired telephony
profit ratio and therefore face similar services, including VoIP services; wired (cable)
ships, thus negating the potential for audio and video programming distribution; wired
substitution. In addition, because these challenges that appear to be endemic to broadband internet services; and, by exception,
are services that need to be done in air transportation. Firms in this industry establishments providing satellite television
particular domestic locations (e.g., that have been able to weather the distribution services using facilities and
pandemic this long are typically highly infrastructure that they operate are included in this
docks), there is no risk of international industry. NAICS 517312 (Wireless
competition. capitalized or have access to loans, so it Telecommunications Carriers (except Satellite))
As with towing, the actual cost is highly likely that they could also comprises establishments primarily engaged in
impacts on this industry are likely weather the temporary marginal costs of operating and maintaining switching and
OSHA’s ETS. transmission facilities to provide communications
significantly overstated to the extent via the airwaves. Establishments in this industry
that some of the employees may be able There is also no risk of international have spectrum licenses and provide services using
to perform their work exclusively competition with respect to this group that spectrum, such as cellular phone services,
outdoors. of NAICS industries because any paging services, wireless internet access, and
workers, whether they work for an wireless video services. NAICS 517410 (Satellite
The Fourteen NAICS Industries With Telecommunications) comprises establishments
international company or not, who are primarily engaged in providing telecommunications
Negative Profit Ratios in the US, are subject to US laws, services to other establishments in the
1. Air Transportation 75 including the ETS, and foreign air telecommunications and broadcasting industries by
carriers will need to follow the ETS for forwarding and receiving communications signals
NAICS 481111 (Scheduled Passenger those workers. In addition, OSHA via a system of satellites or reselling satellite
Air Transportation), NAICS 481112 telecommunications. NAICS 517911
suspects that any smaller foreign air (Telecommunications Resellers) comprises
72 See Jackson, August 2, 2021 ‘‘Equinox also
carriers will not have an incentive to establishments engaged in purchasing access and
expand their routes significantly or network capacity from owners and operators of
noted in the press release that ‘an overwhelming telecommunications networks and reselling wired
majority of members’ have expressed support for a change their routes to domestic US and wireless telecommunications services (except
vaccination requirement for entry to Equinox satellite) to businesses and households.
clubs.’’ scheduled air transportation of mail on a contract Establishments in this industry resell
73 This industry comprises establishments
basis. NAICS 481211 (Nonscheduled Chartered telecommunications; they do not operate
primarily engaged in operating amusement (except Passenger Air Transportation) provides air transmission facilities and infrastructure. NAICS
gambling, billiard, or pool) arcades and parlors. transportation of passengers or passengers and 517919 (All Other Telecommunications) comprises
74 This industry comprises establishments
cargo with no regular routes and regular schedules. establishments primarily engaged in providing
primarily engaged in providing stevedoring and NAICS 481212 (Nonscheduled Chartered Freight specialized telecommunications services, such as
other marine cargo handling services (except Air Transportation) provides air transportation of satellite tracking, communications telemetry, and
warehousing). cargo without transporting passengers with no radar station operation, and also includes
75 NAICS 481111 (Scheduled Passenger Air regular routes and regular schedules. NAICS 481219 establishments primarily engaged in providing
Transportation) provides air transportation of (Other Nonscheduled Air Transportation) provides satellite terminal stations and associated facilities
passengers or passengers and freight over regular air transportation with no regular routes and regular connected with one or more terrestrial systems and
routes and on regular schedules, including schedules (except nonscheduled chartered capable of transmitting telecommunications to, and
commuter and helicopter carriers (except scenic passenger and/or cargo air transportation). These receiving telecommunications from, satellite
and sightseeing). NAICS 481112 (Scheduled Freight establishments provide a variety of specialty air systems, as well as establishments providing
Air Transportation) provides air transportation of transportation or flying services based on internet services or Voice over internet protocol
cargo without transporting passengers over regular individual customer needs using general purpose (VoIP) services via client-supplied
routes and on regular schedules, including aircraft. telecommunications connections.
App. 102
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61503
possible that different forms of NAICS 532120 (Truck, Utility Trailer), www.fcc.gov/licensing-databases/
telecommunications might be and RV (Recreational Vehicle) Rental licensing. (FCC, October 12, 2021a)
substituted for one another (e.g., the and Leasing) NAICS 532310 (General Federal Communications Commission (FCC).
(2021, October 12b) Satellite. https://
substitution of wired Rental Centers).
www.fcc.gov/general/satellite. (FCC,
telecommunications carriers for wireless This group of industries rent motor October 12, 2021b)
telecommunications carriers), the reality vehicles (NAICS 532111, 532112, Groenewold M et al., (2020, July 10).
is that these different forms exist 532120) or equipment (NAICS 532310), Increases in Health-Related Workplace
separately and feed different markets for example, audio visual equipment, Absenteeism Among Workers in
and customer needs that are contractors’ and builders’ tools and Essential Critical Infrastructure
independent of the ETS. Moreover, the equipment, home repair tools, lawn and Occupations During the COVID–19
five NAICS in this group of industries Pandemic—United States, March–April
garden equipment, moving equipment 2020. Centers for Disease Control and
are the only NAICS in NAICS 5173 and supplies, and party and banquet Prevention MMWR Vol. 69, No. 27.
(Wired and Wireless equipment and supplies, to individuals (Groenewold et al., July 10, 2020)
Telecommunications Carriers), NAICS and businesses, for personal and Internal Revenue Service (IRS). (2013). 2013
5174 (Satellite Telecommunications), professional use. There is no risk of Corporation Source Book. https://
and NAICS 5179 (Other substitution with respect to these www.irs.gov/statistics/soi-tax-stats-
Telecommunications). The other industries, as these industries rent corporation-source-book-us-total-and-
industries in NAICS 51 (Information) specific items to those who want to use sectors-listing. (IRS, 2013)
are not engaged in telecommunications Jackson S. (2021, August 2). Gyms like
them. There is also no risk of foreign Equinox and SoulCycle will soon require
(NAICS Association, 2018c). This competition with respect to these
further reduces the risk of one industry members to show proof of vaccination to
industries, as consumers and businesses use their clubs and studios. https://
substituting for the others, as all five rent and pick up vehicles, as well as the www.businessinsider.com/equinox-
NAICS at issue have a negative profit type of equipment offered for rent by soulcycle-will-require-covid-19-vaccines-
ratio and therefore face similar NAICS 532310, from specific locations, for-members-staff-2021–8. (Jackson,
challenges that appear to be endemic to including car rental and other rental August 2, 2021)
telecommunications. centers. NAICS Association. (2018a). NAICS Codes
Moreover, three of the five NAICS Description, 2018: 221118—Other
These industries have not been hard
industries in this group (NAICS 517311, Electric Power Generation. https://
hit by the pandemic, as many www.naics.com/naics-code-description/
517312, 517410) operate or control the
consumers have turned from group ?code=221118. Last accessed October 12,
infrastructure needed for engaging in
travel to individual transportation. For 2021. (NAICS Association, 2018a)
the particular type of
example, RV rentals and leasing has NAICS Association. (2018b). Six Digit NAICS
telecommunications in which those Codes and Titles, 2018: Codes 48–49.
soared during the pandemic, which is
industries engage. This not only fully https://www.naics.com/six-digit-naics/
not reflected in the pre-pandemic profit
negates the risk of substitution, but also ?code=48-49. Last accessed October 12,
and revenue data available for this
negates the risk of international 2021. (NAICS Association, 2018b)
analysis.78
competition for these industries. NAICS Association. (2018c). Six Digit NAICS
The other two industries in the group References Codes and Titles, 2018: Code 51. https://
apparently do not operate or control the www.naics.com/six-digit-naics/
Air Transport Action Group (ATAG). (2005, ?code=51. Last accessed October 12,
infrastructure needed for September). The economic & social
telecommunications. However, the 2021. (NAICS Association, 2018c)
benefits of air transport. https:// NAICS Association. (2018d). NAICS Profile
telecommunications industry faces strict www.icao.int/meetings/wrdss2011/ Page, 2018: Berkshire Hathaway Energy
state and federal licensing requirements, documents/jointworkshop2005/atag_ Co. https://www.naics.com/company-
which severely limit the risk of socialbenefitsairtransport.pdf. (ATAG, profile-page/?co=4973. Last accessed
competition both internationally and September 2005) October 12, 2021. (NAICS Association,
from smaller firms seeking to take Beale HBR. (2003). Financial Data Sources. 2018d)
advantage of the ETS’s 100-employee Microeconomic Applications Inc. (Beale NAICS Association. (2018e). NAICS Profile
cutoff. (See FCC, 2014; FCC, October 12, Report, 2003) Page, 2018: Dominion Energy Inc.
Brown J. (2017, January 19). Bring More https://www.naics.com/company-profile-
2021a; FCC, October 12, 2021b; Diversity to Skiing. https://
Caltrans, October 12, 2021; and UTC, page/?co=11715. Last accessed October
www.powder.com/stories/opinion/ 12, 2021. (NAICS Association, 2018e)
October 12, 2021). extend-the-family/. (Brown, January 19, Occupational Safety and Health
3. Car and Equipment Rental 77 2017) Administration (OSHA). (2016, March
Caltrans. (2021, October 12). Wireless 24). Final Economic and Regulatory
NAICS 532111 (Passenger Car Rental), Licensing Program, California Flexibility Analysis for OSHA’s Rule on
NAICS 532112 (Passenger Car Leasing), Department of Transportation. https:// Occupational Exposure to Respirable
dot.ca.gov/programs/right-of-way/ Crystalline Silica, Chapter VI, pp. VI–20.
77 NAICS 532111 (Passenger Car Rental) wireless-licensing-program. (Caltrans, Docket No. OSHA–2010–0034–4247.
comprises establishments primarily engaged in October 12, 2021) (OSHA, March 24, 2016)
renting passenger cars without drivers, generally for Federal Communications Commission (FCC).
short periods of time. NAICS 532112 (Passenger Car
Occupational Safety and Health
(2021, October 12a) Licensing. https:// Administration (OSHA). (2021a,
Leasing) comprises establishments primarily
engaged in leasing passenger cars without drivers, October). Analytical Spreadsheets in
generally for long periods of time. NAICS 532120 industry typically operate from conveniently Support of the COVID–19 Vaccination
(Truck, Utility Trailer, and RV (Recreational located facilities where they maintain inventories of and Testing ETS. (OSHA, October 2021a)
Vehicle) Rental and Leasing comprises goods and equipment that they rent for short Park S. (2021, January 23). RV sales soar
establishments primarily engaged in renting or periods of time. The type of equipment that during coronavirus pandemic. https://
leasing, without drivers, one or more of the establishments in this industry provide often
includes, but is not limited to: Audio visual
www.foxbusiness.com/lifestyle/rv-sales-
following: Trucks, truck tractors, buses, semi-
trailers, utility trailers, or RVs (recreational equipment, contractors’ and builders’ tools and soar-during-pandemic-travel-road-trip.
vehicles). NAICS 532310 (General Rental Centers) equipment, home repair tools, lawn and garden (Park, January 23, 2021)
comprises establishments primarily engaged in equipment, moving equipment and supplies, and U.S. Census Bureau. (2021, October 8a).
renting a range of consumer, commercial, and party and banquet equipment and supplies. Scientific Integrity. https://
industrial equipment. Establishments in this 78 See Park, January 23, 2021. www.census.gov/about/policies/quality/
App. 103
61504 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
scientific_integrity.html. (US Census includes a Federal mandate that may demands for testing created as a result
Bureau, October 8, 2021a) result in expenditures in any one year of the rule. Therefore, tests used for
U.S. Census Bureau. (2021, October 8b). by state, local, or Tribal governments, or purposes of or for compliance with this
Statement of Commitment to Scientific
by the private sector, of at least $100 ETS are not being produced as a result
Integrity by Principal Statistical
Agencies. https://www.census.gov/ million, adjusted annually for inflation. of this standard, and the standard will
content/dam/Census/about/about-the- The assessment requirement also not generate significant new streams of
bureau/policies_and_notices/ applies to ‘‘any final rule for which a waste beyond what would be generated
scientificintegrity/Scientific_Integrity_ general notice of proposed rulemaking in the absence of the standard.
Statement_of_the_Principal_Statistical_ was published.’’ Although no general
Agencies.pdf. (US Census Bureau, E. Congressional Review Act
notice of proposed rulemaking was
October 8, 2021b) published, the agency has analyzed the This ETS is considered a major rule
Walker C. (2013, January 22). Is Tidal Power under the Congressional Review Act
ETS’s economic feasibility and health
a Viable Source of Energy? https:// (CRA), 5 U.S.C. 801 et seq. Section
www.azocleantech.com/article.aspx? impacts in Section IV.B. of this
ArticleID=350. (Walker, January 22, preamble (Economic Analysis) and 801(a)(3) of the CRA normally requires
2013) Health Impacts Appendix (OSHA, a 60-day delay in the effective date of
Washington Utilities and Transportation October 2021c). a major rule. 5 U.S.C. 801(a)(3), 804(2).
Commission (UTC). (2021, October 12). However, section 808(2) of the CRA
Eligible Telecommunications Carriers. C. Executive Order 13175 allows the issuing agency to make a rule
https://www.utc.wa.gov/regulated- Section 5 of E.O. 13175, on effective sooner than otherwise
industries/utilities/telecommunications/ Consultation and Coordination with provided by the CRA if the agency
federal-universal-service-funds/eligible- Indian Tribal Governments, requires makes a good cause finding that notice
telecommunications-carriers. (UTC,
agencies to consult with tribal officials and public procedure are impracticable,
October 12, 2021)
early in the process of developing unnecessary, or contrary to the public
V. Additional Requirements regulations that: (1) Have tribal interest. 5 U.S.C. 808(2). OSHA finds
implications, that impose substantial that there is good cause to make this
A. Regulatory Flexibility Act
direct compliance costs on Indian rule effective upon publication because
Whenever an agency is required by governments, and that are not required notice and public procedure with
the Administrative Procedure Act, 5 by statute; or (2) have tribal implications respect to this ETS are both
U.S.C. 553, or another law, to publish a and preempt tribal law. 65 FR 67249, impracticable and contrary to the public
general notice of proposed rulemaking, 67250 (Nov. 6, 2000). E.O. 13175 interest, given the expedited timeline on
the Regulatory Flexibility Act (RFA), 5 requires that such consultation occur to which this standard was developed and
U.S.C. 601 et seq., requires the agency the extent practicable. Given the the grave danger threatening workers’
to prepare an initial regulatory expedited nature of issuing the ETS, it lives and health (see Grave Danger and
flexibility analysis (IRFA). 5 U.S.C. was not practicable for OSHA to consult Need for the ETS, both in Section III. of
601(2), 603(a). Since this ETS ‘‘shall and incorporate non-federal input prior this preamble). Congress authorized
serve as a proposed rule’’ for a final to promulgation of the standard. OSHA OSHA to take swift action in
standard under section 6(c)(3) of the commits to meaningful consultation promulgating an ETS to address this
OSH Act, it is treated as a general notice with tribal representatives after type of grave danger, and provided
of proposed rulemaking under the RFA. publication of the ETS and during the explicitly that an ETS is effective upon
An agency may waive or defer the IRFA comment period before finalizing any publication, 29 U.S.C. 655(c)(1);
in the event a rule is promulgated in permanent standard. Such consultation delaying the effective date of such an
response to an emergency that makes will be consistent with the expedited process would thwart that
compliance with the requirements of Administrative Procedure Act. purpose. It is specifically because of the
section 603 impracticable. 5 U.S.C. emergency nature of this rulemaking
D. National Environmental Policy Act
608(a). The agency hereby certifies that that the OSH Act allows for OSHA to
compliance with the IRFA requirement OSHA has reviewed this ETS proceed without the extensive public
is impracticable under the according to the National input the agency normally solicits in
circumstances. OSHA prepared this ETS Environmental Policy Act (NEPA) of issuing occupational safety and health
on an expedited basis in response to a 1969, 42 U.S.C. 4321 et seq., the standards. 29 U.S.C. 655(c)(1). For rules
national emergency affecting the lives regulations of the Council on to which section 808(2) applies, the
and health of the nation’s workers; the Environmental Quality, 40 CFR chapter agency may set the effective date. In this
IRFA is inherently a relatively lengthy V, subchapter A, and the Department of case, consistent with the OSH Act
process that would be impracticable to Labor’s NEPA procedures, 29 CFR part requirement cited above, the ETS takes
undertake for a standard of such broad 11. As a result of this review, the agency immediate effect upon publication in
applicability in the limited time has determined that the rule will have the Federal Register.
available. Because OSHA is not no significant impact on air, water, or
soil quality; plant or animal life; the use F. Administrative Procedure Act
preparing an IRFA for the ETS, the
agency is also not required to convene of land; or other aspects of the external The Administrative Procedure Act
a small entity panel under section environment. Although the ETS (APA) normally requires notice and
609(b). contains testing requirements, and test comment, and a 30-day delay of the
kits and supplies can generate some effective date of a final rule, for
B. Unfunded Mandates Reform Act additional materials that will enter the recordkeeping and reporting regulations
(UMRA), 2 U.S.C. 1501 et seq. waste stream, the impact of this ETS promulgated under section 8(c) of the
Section 202 of the Unfunded will be minimal. As discussed in more OSH Act. 29 U.S.C. 657(c); 5 U.S.C.
Mandates Reform Act of 1995 (UMRA), detail in Technological Feasibility 553(b), (d). This ETS contains
2 U.S.C. 1532, requires agencies to (Section IV.A. of this preamble), there is recordkeeping and reporting
assess the anticipated costs and benefits already a surplus of available tests, and requirements tailored to address
of a rule before issuing ‘‘any general projected production of COVID–19 tests COVID–19 illness. To the extent that
notice of proposed rulemaking’’ that will be more than sufficient to meet these requirements are not already
App. 104
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exempt from the APA’s requirements for of why the planned regulation is occupational safety and health
notice and comment under section 6(c) preferable to other potentially effective standards.
of the Act (29 U.S.C. 655(c)), OSHA and reasonably feasible alternatives This ETS complies with E.O. 13132.
invokes the ‘‘good cause’’ exemption to considered by the agency (62 FR 19885 The problems addressed by this ETS for
the APA’s notice requirement because (April 23, 1997)). Executive Order 13045 COVID–19 are national in scope. As
the agency finds that notice and public defines ‘‘covered regulatory actions’’ as explained in Grave Danger (Section
procedure are impracticable and rules that may (1) be economically III.A. of this preamble), employees face
contrary to the public interest under 5 significant under Executive Order a grave danger from exposure to
U.S.C. 553(b)(B). As explained in more 12866, and (2) concern an COVID–19 in the workplace. Employees
detail in Grave Danger and Need for the environmental health risk or safety risk across the country face the danger of
ETS (both in Section III. of this that an agency has reason to believe may exposure to COVID–19 at work, and as
preamble), this finding is based on the disproportionately affect children. explained in Need for the ETS (Section
critical importance of implementing the Because OSHA has no reason to believe III.B. of this preamble), a national
requirements in this ETS, including the that the risk from COVID–19 standard is needed to protect workers
recordkeeping and reporting provisions, disproportionately affects children, the from the grave danger of COVID–19 by
as soon as possible to address the grave ETS is not a covered regulatory action strongly encouraging vaccination and
danger that COVID–19 presents to and OSHA is not required to provide limiting the presence of COVID–19
workers. OIRA with further analysis under positive workers in the workplace
As noted above, the ETS is required section 5 of the executive order. through testing and to ensure that a
by the OSH Act to take immediate effect However, to the extent children are clear and consistent baseline approach
upon publication. 29 U.S.C. 655(c)(1). exposed to COVID–19 either as is taken across the country to protect
For that reason, and the underlying employees or at home as a result of them. The SARS–CoV–2 virus is highly
public health emergency that prompted family members’ workplace exposures communicable and infects workers
this ETS as discussed above, OSHA to COVID–19, the ETS should provide without regard to state borders, making
finds good cause to waive the normal some protection for children. a national approach necessary.
30-day delay in the effective date of a Accordingly, the ETS establishes
final rule from the date of its I. Federalism minimum requirements for employers
publication in the Federal Register. See The agency reviewed this ETS in every State to protect employees from
5 U.S.C. 553(d)(3). OSHA notes, according to Executive Order 13132, on the risks of exposure to COVID–19.
however, that OSHA does not require Federalism, which requires that Federal In States without OSHA-approved
compliance with any provision of the agencies, to the extent possible, refrain State Plans, Congress provides for
ETS within the first 30 days after it from limiting State policy options, OSHA standards to preempt State
becomes effective. consult with States before taking actions occupational safety and health
that would restrict States’ policy standards for issues addressed by the
G. Consensus Standards options, and take such actions only Federal standards. In these States, this
OSHA must consider adopting an when clear constitutional authority ETS limits State policy options in the
existing national consensus standard exists and the problem is of national same manner as every standard
that differs substantially from OSHA’s scope. 64 FR 43255 (August 10, 1999). promulgated by the agency.
standard if the consensus standard The Executive Order generally allows Furthermore, as discussed in the
would better effectuate the purposes of Federal agencies to preempt State law Summary and Explanation for Purpose,
the Act. See section 12(d)(1) of the only as provided by Congress or where nothing in the ETS is intended to limit
National Technology Transfer and State law conflicts with Federal law. In generally applicable public health
Advancement Act of 1995 (15 U.S.C.A. such cases, Federal agencies must limit measures instituted by state or local
272 Note); see also 29 U.S.C. 655(b)(8). preemption of State law to the extent governments that go beyond, and are not
OSHA considered incorporation of possible. inconsistent with, the requirements of
ASTM F3502–21 in this ETS, as The Occupational Safety and Health the ETS. (See Summary and
required. However, the agency has Act is an exercise of Congress’s Explanation for Purpose, Section VI.A.
insufficient evidence to make a general Commerce Clause authority, and under of this preamble); Gade v. National
finding of feasibility at this time. The Section 18 of the Act, 29 U.S.C. 667, Solid Wastes Management Ass’n, 505
agency notes that face coverings that Congress expressly provided that States U.S. 88, 107 (1992). In States with
meet ASTM F3502–21 criteria also meet may adopt, with Federal approval, a OSHA-approved State Plans, this ETS
the definition of ‘‘face coverings’’ in this plan for the development and does not significantly limit State policy
ETS (see the discussion of this issue in enforcement of occupational safety and options. Any special workplace
Summary and Explanation, Section VI. health standards. OSHA refers to States problems or conditions in a State with
of this preamble). The agency has asked that obtain Federal approval for such an OSHA-approved State Plan may be
questions about this topic to gather plans as ‘‘State Plans.’’ Occupational dealt with by that State’s standard,
additional information. safety and health standards developed provided the standard is at least as
by State Plans must be at least as effective as this ETS.
H. Executive Order 13045 effective in providing safe and healthful As discussed in the Summary and
Executive Order 13045, on Protection employment and places of employment Explanation for Purpose in this
of Children from Environmental Health as the Federal standards. As discussed preamble, OSHA has included a
Risks and Safety Risks, requires that below, State Plans must submit to provision that states the purpose of this
Federal agencies submitting covered Federal OSHA for approval, standards ETS, as well as OSHA’s intent to
regulatory actions to OIRA for review that differ from Federal standards preempt all inconsistent State and local
pursuant to Executive Order 12866 must addressing the same issues, in order for requirements that relate to the issues
provide OIRA with (1) an evaluation of such standards to become part of the addressed by this ETS. (See section
the environmental health or safety OSHA-approved State Plan. Subject to 1910.501(a); Summary and Explanation
effects that the planned regulation may these requirements, State Plans are free for Purpose, Section VI.A. of this
have on children, and (2) an explanation to develop and enforce their own preamble). This includes State and local
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61506 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
requirements banning or limiting the cover only state and local government normal clearance procedures if either (a)
authority of employers to require employees: Connecticut, Illinois, Maine, the relevant agency determines that the
vaccination, face covering, or testing. As New Jersey, New York, and the Virgin collection of information is essential to
discussed in that section, such State and Islands. the mission of the agency and public
local bans would be preempted by this harm is reasonably likely to result if
K. Paperwork Reduction Act
ETS, even in States with OSHA- normal clearance procedures are
approved State Plans, because such bans I. Overview followed, or (b) the use of normal
are not approved by federal OSHA as The Emergency Temporary Standard clearance procedures is reasonably
part of the State Plan and could not be (ETS) for COVID–19 Vaccination and likely to cause a statutory or court
approved, because such bans are clearly Testing contains collection of ordered deadline to be missed (44
not as effective—and, indeed, are information requirements that are U.S.C. 3507(j) and 5 CFR 1320.13).
contrary to—the federal ETS. See subject to review by the Office of Because COVID–19 presents an ongoing
Indust. Truck Ass’n v. Henry, 125 F.3d Management and Budget (OMB) under public health threat to workers and
1305, 1311 (9th Cir. 1997). the Paperwork Reduction Act of 1995 American businesses, OSHA has
(PRA), 44 U.S.C. 3501, et seq., and requested the use of these emergency
J. State Plans
OMB’s regulations at 5 CFR part 1320. procedures for this ETS. In accordance
When Federal OSHA promulgates an with 44 U.S.C. 3507(j)(1), OMB
The PRA defines a collection of
emergency temporary standard, States approved the request and assigned this
information to mean the obtaining,
and U.S. Territories with their own ETS an OMB control number that is
causing to be obtained, soliciting, or
OSHA-approved occupational safety valid for 180 days. Therefore, the
requiring the disclosure to third parties
and health plans (‘‘State Plans’’) must information collection provisions
or the public, of facts or opinions by or
either amend their standards to be contained within this ETS will take
for an agency, regardless of form or
identical or ‘‘at least as effective as’’ the effect at the same time as all other
format (44 U.S.C. 3502(3)(A)). OSHA
new standard, or show that an existing provisions.
has determined an ETS is necessary to
State Plan standard covering this area is
protect workers from the grave danger II. Summary of Information Collection
‘‘at least as effective’’ as the new Federal
posed by COVID–19 and is issuing an Requirements
standard. 29 CFR 1953.5(b). This ETS
ETS that amends 29 CFR 1910 subpart
imposes new requirements to protect This information collection is
U to provide COVID–19 protections to
workers across the nation from COVID– summarized as follows.
workers of employers with 100 or more
19. Adoption of this ETS, or an ETS that 1. Title: COVID–19 Vaccination and
employees. Section 1910.501 contains
is at least as effective as this ETS, by Testing Emergency Temporary Standard
collections of information necessary to
State Plans must be completed within (29 CFR 1910, subpart U; 1915, subpart
effectuate the purpose of the ETS. The
30 days of the promulgation date of the Z; 1917, subpart B; 1918, subpart K;
collections of information appear in
final Federal rule, and State Plans must 1926, subpart D; 1928, subpart B).
paragraphs 1910.501(d), (e)(2), (e)(4), 2. Type of Review: Emergency.
notify Federal OSHA of the action they
(f)(1), (g)(1), (g)(4), (h)(1), (j), (k)(1), 3. OMB Control Number: 1218–0278.
will take within 15 days. The State Plan
(k)(2), (l)(1), and (l)(2). For a more 4. Affected Public: This rule applies to
standard must remain in effect for the
comprehensive discussion of these employers with a total of 100 or more
duration of the Federal ETS. As noted
provisions, see the sectional analysis employees except where the workplace
above in Federalism (Section V.I. of this
earlier in this preamble. These is covered under the Safer Federal
preamble), this ETS preempts all State
information collections are applied by Workforce Task Force COVID–19
and local requirements, including in
cross reference to other industries in Workplace Safety: Guidance for Federal
States with State Plans, that ban or limit
regulations 29 CFR 1915.1501 (Shipyard Contractors and Subcontractors; or in
the authority of employers to require
Employment), 1917.31 (Marine setting where the employee provides
vaccination, face covering, or testing.
Terminals), 1918.110 (Longshoring), healthcare services or healthcare
(See also the Summary and Explanation
1926.58 (Construction), 1928.21 support services that falls under the
for Purpose, Section VI.A. of this
(Agriculture).79 requirements of 29 CFR 1910.502. This
preamble). As with all non-identical Under the PRA, a Federal agency
State Plan standards, OSHA will review rule does not apply to employees of
cannot conduct or sponsor a collection
any comparable State standards to covered employers who work from
of information unless OMB approves it
determine whether they are at least as home, exclusively outdoors, or who do
and the agency displays a currently
effective as this ETS. A State Plan not report to a workplace where other
valid OMB control number (44 U.S.C.
standard that prohibits employers from individuals such as coworkers or
3507). Notwithstanding any other
requiring vaccination would not be at customers are present.
provision of law, if a collection of
least as effective as this ETS because 5. Description of the ICR. This ICR
information does not display a currently
OSHA has recognized in this ETS that contains collections of information
valid control number, an employer shall
vaccination is the most protective policy requirements for employers with 100 or
not be subject to penalty for failing to
choice for employers to adopt to protect more employees. The employer must
comply with the collection of
their workplaces. establish, implement, and enforce a
information (44 U.S.C. 3512). The PRA
Of the 28 States and Territories with written mandatory vaccination policy
has special provisions for emergency
OSHA-approved State Plans, 22 cover that requires each employee to be fully
situations that are applicable to this
both public and private-sector vaccinated against COVID–19 unless the
ETS. OMB may authorize a collection of
employees: Alaska, Arizona, California, information without regard to the employer implements a policy that
Hawaii, Indiana, Iowa, Kentucky, allows employees to choose between
Maryland, Michigan, Minnesota, 79 The ETS applies to agricultural establishments being fully vaccinated or both tested
Nevada, New Mexico, North Carolina, with 11 or more employees engaged on any day in and wearing a face covering. Employers
Oregon, Puerto Rico, South Carolina, hand-labor occupations in the field and agricultural must determine employee vaccination
establishments that maintain a temporary labor status, and must require than any
Tennessee, Utah, Vermont, Virginia, camp, regardless of how many employees are
Washington, and Wyoming. The engaged on any day in hand-labor occupations in employees who are not vaccinated be
remaining six States and Territories the field). tested for COVID–19 at least once every
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61507
7 days. Employers must provide October). Health Impacts of the COVID– Second, State and local laws that do
specified information to employees 19 Vaccination and Testing ETS. (OSHA, not constitute occupational safety or
regarding COVID–19 vaccine efficacy, October 2021c) health laws because they are ‘‘laws of
safety, and the benefits of being VI. Summary and Explanation general applicability’’ that regulate
vaccinated, and must maintain a record workers and nonworkers alike are
of the COVID–19 vaccination status, A. Purpose preempted only if they conflict with the
proof of vaccination, and copies of The ETS includes a sentence that federal standard. Laws of general
employee COVID–19 test results, and states the purpose of the rule. The first applicability that are consistent with the
the aggregate number of fully vaccinated part of the sentence in the paragraph federal standard are not preempted.
employees at a workplace along with indicates that the standard addresses the Gade, 505 U.S. at 107.
the total number of employees at that grave danger of COVID–19 in the While section 18 applies to every
workplace. workplace by establishing workplace occupational safety and health standard
6. Number of respondents: 1,858,935. vaccination, vaccination verification, that OSHA promulgates, this ETS raises
7. Frequency: Varies. face covering and testing requirements. particular concerns because of the
8. Number of Responses: 205,262,803. current landscape of existing State and
The second part of the sentence
9. Estimated Burden Hours: local requirements that may overlap
addresses the preemption of State and
79,720,444. with, or directly conflict with, the
10. Estimated Cost (Capital-operation local laws, regulations, executive orders,
and other requirements, by this Federal requirements of this ETS. As discussed
and maintenance): $1,383,751,520. in Need for the ETS (Section III.B. of
These totals are explained and standard. It indicates OSHA’s intention
that the ETS address comprehensively this preamble), OSHA is adopting this
supported in the agency’s Supporting ETS in response to an unprecedented
Statement as required by the PRA. the occupational safety and health
issues of vaccination, wearing face health crisis that has resulted in a global
III. Request for Comment coverings, and testing for COVID–19, pandemic severely impacting the health
and thus that the standard is intended and wellbeing of people in the United
Although the ETS takes effect
to preempt States, and political States, and globally. This ETS is issued
immediately, with implementation
subdivisions of States, from adopting based on OSHA’s determination that
dates specified in the Dates provision of
and enforcing workplace requirements employees in the United States face a
this publication, it also serves as a
relating to these issues, except under the grave danger from workplace exposures
temporary standard that can only be
to SARS–CoV–2, that the ETS is
made permanent following an authority of a Federally-approved State
necessary to protect those workers, and
opportunity for public notice and Plan. In particular, OSHA intends to
that the measures for vaccination,
comment. OSHA therefore invites the preempt any State or local requirements
vaccine verification, face coverings, and
public to submit comments to OSHA on that ban or limit an employer’s authority
testing that this ETS requires will help
the proposed collections of information to require vaccination, face covering, or
ensure that workers covered by the ETS
with regard to the following. testing.
• Whether the proposed collections of are protected from severe illness and
Preemption of such State and local
information are necessary for the proper death resulting from contracting
requirements derives from section 18 of
performance of the Agency’s functions, COVID–19 in the workplace.
OSH Act and general principles of As explained in Need for the ETS
including whether the information is conflict preemption. See Gade v. (Section III.B. of this preamble), the lack
useful. National Solid Wastes Management
• The accuracy of OSHA’s estimate of of a national standard on this hazard has
Ass’n, 505 U.S. 88 (1992).80 Gade led to disparate State and local
the burden (time and cost) of the clarified two important principles. First,
collections of information, including the requirements, and this underscores the
section 18 expresses Congress’ intent to need for OSHA’s ETS to provide clear
validity of the methodology and preempt State workplace safety or
assumptions used. and consistent protection to employees
health laws relating to issues on which across the country. Over the past
• The quality, utility, and clarity of Federal OSHA has promulgated
the information collected. months, an increasing number of States
occupational safety and health have passed laws or enacted other
• Ways to minimize the compliance standards. Under section 18, a State can
burden on employers, for example, by requirements banning workplace
avoid preemption of such laws only if vaccination policies that would
using automated or other technological
it submits and receives Federal approval mandate vaccination or require proof of
techniques for collecting and
for a State Plan for the development and vaccination status, thus prohibiting
transmitting information.
Please submit comments related to the enforcement of standards. OSHA- employers operating in those
Paperwork Act analysis to OSHA in the approved State Plans operate under jurisdictions from implementing this
PRA docket (Docket Number OSHA– authority of State law and must adopt proven method of protecting workers
2021–0008). Comments related to other occupational safety and health from the hazard of COVID–19 that is at
parts of the ETS should be submitted to standards which, among other things, the core of this ETS (see, e.g., Texas
the rulemaking docket (Docket Number must be at least as effective in providing Executive Order GA–40, October 11,
OSHA–2021–0007). OSHA will accept safe and healthful employment and 2021; Montana H.B. 702, July 1, 2021;
comments for 60 days on the places of employment as Federal Arkansas S.B. 739, October 4, 2021 and
information collection aspects of the standards. 29 U.S.C. 667. Arkansas H.B. 1977, October 1, 2021;
rule. For instructions on submitting AZ Executive Order 2021–18, Aug. 16,
80 The Court held that the dual impact licensing
these comments to the rulemaking and/ 2021). While some States’ bans have
statutes were preempted; however, no rationale
or PRA docket, see the sections of this commanded a majority. A four-justice plurality
focused on preventing local
Federal Register notice titled DATES and found that supplementary State regulation is governments from requiring their public
ADDRESSES. impliedly preempted. Id. at 98–99. Justice employees to be vaccinated or show
Kennedy’s concurrence would have found express proof of vaccination, the Texas,
References preemption rather than implied preemption, Id. at
Montana, and Arkansas requirements
110–111, but otherwise agreed that ‘‘in the OSH
Occupational Safety and Health statute Congress intended to pre-empt apply to private employers as well.
Administration (OSHA). (2021c, supplementary state regulation.’’ Id. at 113. Likewise, some States and localities
App. 107
61508 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
have enacted requirements that prohibit 505 U.S. at 99. As the Court explained, aimed at distinct and different evils’’
businesses, government offices, schools section 18 preempts States without but whether they ‘‘operate upon the
or other public spaces from requiring approved plans from adopting or same object’’).
that face coverings be worn (see, e.g., enforcing any laws that constitute, ‘‘in That a State has articulated a purpose
Florida Executive Order 21–102, May 3, a direct, clear and substantial way other than, or in addition to, workplace
2021; Texas Executive Order GA–34, regulation of worker health and safety’’ health and safety would not divest the
March 2, 2021; Texas Executive Order relating to an issue addressed by an OSH Act of its preemptive force,
GA–36, May 18, 2021). State and local OSHA standard. Id. at 107. because preemption law looks to the
requirements that prohibit employers State and local requirements that ban effects as well as the purpose of a State
from implementing employee or otherwise limit workplace law, and thus a dual-impact State law
vaccination mandates, or from requiring vaccination, face covering, or testing cannot avoid OSH Act preemption
face coverings in workplaces, serve as a clearly ‘‘relate’’ to the occupational simply because the regulation serves
barrier to OSHA’s implementation of safety and health ‘‘issues’’ that OSHA is several objectives. Gade, 505 U.S. at 107
this ETS, and to the protection of regulating in this ETS. 29 U.S.C. 667(b). (holding ‘‘a law directed at workplace
America’s workforce from this deadly Such bans regulate key workplace safety is not saved from pre-emption
virus. COVID–19 protections that are simply because the State can
As discussed below, state restrictions encompassed by this ETS ‘‘in a direct, demonstrate some additional effect
of this kind are clearly preempted clear and substantial way.’’ Gade, 505 outside of the workplace’’ and ‘‘[t]hat
whether they take the form of direct U.S. at 107. The direct effect of such such law may also have a
workplace regulation or are part of a law bans is to prohibit employers from nonoccupational impact does not render
of general applicability because they requiring employees to implement it any less of an occupational standard
relate to the issues addressed by this measures, such as vaccination for purposes of pre-emption analysis’’).
standard and conflict with it. Gade, 505 requirements, face coverings, or testing. Thus, to the extent that the stated
U.S. at 99, 107. As is also discussed These workplace protective measures purpose of a requirement that bans or
below, this is true even for State or local are covered by, and, in many limits employers from requiring
requirements that may not prevent circumstances required by, this ETS. For vaccinations, face coverings, or testing
employers from compliance with the example, vaccination mandate bans is something other than, or in addition
ETS, but that prescribe or limit the directed at employers specifically bar to, occupational health, such laws,
employer’s ability to mandate them from requiring employee which have a specific and direct impact
vaccination for its workforce as the vaccination requirements for the on worker health, are nevertheless
employer’s chosen means of purposes of protecting their workforce. preempted.
compliance. See Gade, 505 at 107; see Prohibitions on face covering mandates Further, section 18 preempts even
also Geier v. American Honda, 529 U.S. likewise directly prohibit individuals in ‘‘nonconflicting’’ State and local
861, 869, 875–886 (2000) (finding positions of authority, including occupational safety and health
Department of Transportation (DOT) employers, from requiring face covering requirements relating to the issues
regulations preempted a State tort action use. addressed by this standard. Gade, 505
where the state action ‘‘upset the careful Although the expressly stated U.S. at 98–99, 103; see id. at 100 (‘‘state
regulatory scheme established by federal purposes for State and local laws regulating the same issue as federal
law’’ and placing weight on DOT’s requirements banning or limiting laws are not saved, even if they merely
interpretation that such tort suit would employers from requiring vaccinations, supplement the federal standard’’). This
be ‘‘an obstacle to the accomplishment face coverings, or testing may not be is because OSHA ‘‘’pre-empts the field’
and execution’’ of Agency objectives). occupational safety and health,81 this for any nonapproved State law
An employer’s choice to mandate does not control their preemption under regulating the same safety and health
vaccination is a critical aspect of this section 18 of the OSH Act. In assessing issue.’’ See Gade, 505 U.S. at 104, n. 2,
ETS, and state laws that remove that State and local requirements’ impact on citing English v. General Electric. Co.,
choice conflict with it. a federal statutory scheme, courts ‘‘have 496 U.S. 72, 79–80, n.5 (‘‘[F]ield
Thus, to ensure that the ETS refused to rely solely on the legislature’s preemption may be understood as a
supplants the existing State and local professed purpose and have looked as species of conflict pre-emption: A State
vaccination bans and other well to the effects of the law.’’ Gade, 505 law that falls within a pre-empted field
requirements that could undercut its U.S. at 105; see also, e.g., Perez v. conflicts with Congress’ intent (either
effectiveness, and to foreclose the Campbell, 402 U. S. 637, 651–652 (1971) express or plainly implied) to exclude
possibility of future bans, OSHA has (‘‘[A]ny state legislation which frustrates state regulation’’); see also id. at 105
clearly defined the issues addressed by the full effectiveness of federal law is (discussing effect of field preemption).
this section to encompass vaccination, rendered invalid by the Supremacy See generally Geier, 529 U.S. at 869,
face covering, and testing needed to Clause’’); Napier v. Atlantic Coast Line 875–886 (finding State law preemption
protect against transmission of COVID– R. Co., 272 U.S. 605, 612 (1926) (pre- where it ‘‘upset the careful regulatory
19 to employees in the workplace. To emption analysis does not depend on scheme established by federal law’’);
avoid ambiguity, OSHA has stated whether federal and State laws ‘‘are Williamson v. Mazda Motor of Am., Inc.,
expressly that it intends this ETS to 562 U.S. 323, 330–36 (2011) (affirming
preempt all State and local workplace 81 The express purposes of such requirements the conflict pre-emption principle that
requirements that ‘‘relate’’ to these banning or limiting employers from requiring ‘‘a state law that stands as an obstacle
issues, except pursuant to a State Plan. vaccination, face coverings, or testing may often not to the accomplishment and execution of
relate to occupational safety and health. For
29 U.S.C. 667(b). example, Governor Greg Abbott’s Texas face the full purposes and objectives of a
The ‘‘unavoidable implication’’ of covering mandate ban in Executive Order GA–16, federal law is pre-empted’’ and finding
section 18 is that because OSHA has is based on alleged decreasing COVID–19 rates and preemption where State law interfered
adopted this ETS, States may no longer the need to alleviate ‘‘confusion,’’ (Texas Executive with ‘‘significant objective’’ of the
Order GA–36, May 18, 2021); the stated purpose of
regulate these issues except with Montana’s vaccination mandate ban is to address federal regulation).
OSHA’s approval and the authority of a health care privacy interests (Montana H.B. 702, For example, the ETS would preempt
Federally-approved State Plan. Gade, July 1, 2021). State or local governments from
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61509
dictating that employers adopt a scheme therefore, the authority to determine protective State and local regulations of
of testing and face coverings that which ‘‘issues’’ to address with general applicability that mandate face
complies with 1910.501(g) and (i) of the occupational safety and health coverings or vaccination will
ETS, but that bars employers from standards. See Indust. Truck, 125 F.3d complement, rather than interfere with
electing the preferred vaccine mandate at 1311 (relying on OSHA’s regulation OSHA’s enforcement of the ETS, and
alternative in paragraph (d), because and statements in the preamble to also does not intend to preempt such
this interferes with OSHA’s significant identify the relevant ‘‘issue’’ for requirements. Indeed, OSHA believes
regulatory objectives and its preemption preemption purposes in OSHA’s Hazard that such measures have significantly
of the field.82 (See Need for the ETS Communication standard). reduced the harmful effects of the
(Section III.B. of this preamble) Importantly, although OSHA’s stated pandemic and total fatalities. See Steel
discussing that vaccination is the intention is to preempt conflicting State Institute of NY v. The City of NY, 716
preferred compliance option under this and local requirements relating to the F.3d 31, 38 (affording some weight to
rule because it is the most effective issues addressed by this standard, OSHA’s view that municipal regulations
method of protecting workers from OSHA recognizes that the OSH Act does governing construction cranes did not
COVID–19). Likewise, the ETS would not allow, and OSHA does not intend, interfere with OSHA’s regulatory
preempt such State or local for the ETS to preempt non-conflicting scheme in its crane standards and
occupational requirements, even to the State or local requirements of general ultimately adopted OSHA’s view in
extent that they may regulate employers applicability. In Gade, the Supreme finding these municipal regulations
with fewer than 100 employees, Court qualified its ruling by saving from were not preempted by OSHA crane
notwithstanding that the requirements preemption non-conflicting State and standards).83
in this ETS only apply to employers local ‘‘laws of general applicability
with more than 100 employees. (such as laws regarding traffic safety or In Steel Institute, the Second Circuit
Case law is instructive on this point. fire safety) that do not conflict with held that OSHA’s crane regulations did
In Gade, the Supreme Court found OSHA standards and that regulate the not preempt New York City municipal
regulations implementing a State statute conduct of workers and nonworkers regulations governing construction
that required training for workers alike.’’ Gade, 505 U.S. at 107. The cranes, finding that such regulations
handling hazardous waste that went Majority reasoned that, ‘‘[a]lthough were requirements of general
beyond, but did not conflict with, some laws of general applicability may applicability, notwithstanding their
OSHA’s hazardous waste training have a ‘direct and substantial’ effect on direct bearing on worker safety, because
requirements to be preempted by the worker safety, they cannot fairly be their primary purpose and effect was to
OSHA requirements. Id. Likewise, in characterized as ‘occupational’ preserve the safety of the general public,
Industrial Truck Association standards, because they regulate and they regulated workers and
Incorporated v. Henry, the Ninth Circuit workers simply as members of the nonworkers alike. Id. The Steel Institute
found that OSHA’s hazard general public.’’ Id. court noted the ‘‘strong presumption
communication standard preempted During the pandemic, many States against preemption when states and
California’s Hazard Communication and municipal governments have localities ‘‘exercise[ ] their police
regulations that were not submitted to adopted requirements intended to powers to protect the health and safety
OSHA for approval through its State protect public health by helping to of their citizens.’’ Id. at 36, citing
Plan, even to the extent that California’s prevent the spread of COVID–19 in Medtronic, Inc. v. Lohr, 518 U.S. 470,
Hazard Communication rule regulated public spaces. These have included 475 (1996). The Second Circuit was also
manufacturers and distributers who requirements mandating face coverings influenced by the clear danger
were excluded from coverage under in indoor public spaces, including presented to the public by unsafe crane
federal OSHA’s rule. Indust. Truck businesses, government buildings, and operation. This is analogous to the
Ass’n v. Henry, 125 F.3d 1305, 1311–14 schools (see, e.g., Baltimore City Health situation here, because exposure to
(9th Cir. 1997). In the same way, the Department, August 10, 2021; Illinois COVID–19 is a hazard that directly
ETS preempts all State and local Executive Order 2021–20, August 26, impacts everyone. Thus, generally
requirements that bar or limit the ability 2021; Hawai’i Emergency Proclamation, applicable State and local mandates
of an employer to require workplace October 1, 2021). In addition, in recent requiring face coverings or vaccination
vaccination, testing, and face coverings months, some States and municipal should not be preempted and should
to protected employees against COVID– governments have adopted requirements
19 in any respect, since OSHA has mandating that members of the public 83 OSHA’s Cranes and Derricks in Construction
occupied the entire field of regulation provide proof of vaccination or recent rule directly discussed its expectations and intent
on these issues. COVID–19 testing in order to enter regarding the preemptive effect of the rule,
restaurants, bars, or other businesses or including that it was not intended to preempt
OSHA’s definition of the ‘‘issue’’ in generally applicable municipal regulations, such as
this rule should be afforded weight, public spaces (see, e.g., NYC Emergency building codes, which serve public safety purposes.
since the OSH Act vests OSHA with Executive Order 225, August 16, 2021 Cranes and Derricks in Construction, 75 FR 47,906,
standard-setting responsibility and, (mandating COVID–19 vaccination for 48,128 (August 9, 2010). This rule also includes a
most individuals for indoor provision that requires employers to comply with
State crane operator licensing requirements that
82 OSHA is aware that some States have adopted entertainment, recreation, dining and meet the federal floor for crane operator
or are considering adopting such requirements, fitness settings)). Requirements such as certification in the rule. 29 CFR 1926.1427(c)(1).
which this ETS would preempt (see, e.g., Arkansas these apply to ‘‘workers and nonworkers OSHA has also indicated that its rule would not
S.B. 739, October 4, 2021 and Arkansas H.B. 1977, alike’’ and ‘‘regulate workers simply as preempt State or local requirements in other
October 1, 2021, which Arkansas Governor Asa rulemakings. See e.g., 72 FR 7136, 7188 (Feb. 14,
Hutchinson allowed to became law without his member of the general public’’ and are 2007) (Preamble to OSHA’s most recent electrical
signature, and which require employers in Arkansas accordingly not preempted. Gade, 505 safety standard) (‘‘State and local fire and building
to allow employees to opt out of vaccination for U.S.at 107. codes, which are designed to protect a larger group
purposes of complying with federal vaccination Based on OSHA’s observations and of persons than employees,’’ are not preempted); 29
requirements; see also Governor Hutchinson, CFR 1910.134(e) (requiring compliance with State
October 13, 2021; Marr, October 7, 2021 (describing
experience during the past year and a and local laws by requiring ‘‘a licensed health care
the Arkansas legislation and noting that other states half that the pandemic has been professional’’ to perform a medical evaluation of an
may contemplate similar legislation)). ongoing, OSHA is confident that employee’s ability to use a respirator).
App. 109
61510 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
remain in effect, notwithstanding this adopt a State emergency temporary employers might agree to cover the costs
ETS.84 standard,’’ or to demonstrate ‘‘that of face coverings or medical removal, or
On the other hand, as noted above, promulgation of an emergency to a requirement that all employees,
this standard will preempt requirements temporary standard is not necessary regardless of vaccination status, wear
that conflict with it, regardless of because the State standard is already the face coverings while working indoors.
whether the requirements are part of a same or at least as effective as the
References
law of general applicability.85 Federal standard change.’’ 29 CFR
The effect of the ETS on State law 1953.5(b)(1). The new ETS becomes part An Act Prohibiting Discrimination Based on
requirements in State Plan States works of the OSHA-approved State Plan a Person’s Vaccination Status or
somewhat differently. As previously through the State Plan’s submission to Possession of an Immunity Passport;
Montana H.B. 702. (2021, July 1). https://
noted, under section 18 of the OSH Act OSHA documentation showing it leg.mt.gov/bills/2021/billpdf/
States that wish to assume adopted an identical ETS or a ‘‘Plan HB0702.pdf. (Montana H.B. 702, July 1,
responsibility for the development and Change Supplement’’ showing that it 2021)
enforcement of ‘‘occupational safety and has adopted requirements that are ‘‘at Arizona Executive Order 2021–18. (2021,
health standards relating to any least as effective’’ as federal OSHA’s August 16). https://azgovernor.gov/sites/
occupational safety or health issue with ETS. 29 CFR 1953.5(b)(3); 1953.4. default/files/eo_2021–18.pdf. (AZ
respect to which a Federal standard has Even in States with OSHA-approved Executive Order 2021–18, August 16,
State Plans, any State law relating to an 2021)
been promulgated’’ may submit a State Arkansas H.B. 1977. (2021, October 1). To
Plan to OSHA for approval. Id. section occupational safety and health issue Provide Employee Exemptions From
667(b); see also id. section 667(c) that OSHA regulates is preempted Federal Mandates and Employer
(describing requirements for OSHA unless it is submitted for OSHA’s Mandates Related to Coronavirus 2019
approval of State Plans on issues for approval as a supplement to the State (COVID–19); and to Declare an
which OSHA has adopted standards). Plan. Indust. Truck Ass’n, 125 F.3d at Emergency. https://
There are 22 States and territories that 1311 (‘‘If a State wishes to regulate an www.arkleg.state.ar.us/Bills/
issue of worker safety for which a FTPDocument?path=%
have OSHA-approved State Plans for
2FAMEND%2F2021R%2FPublic%
private employers, and 6 additional federal standard is in effect, its only
2FHB1977–H1.pdf. (Arkansas H.B. 1977,
States and territories that have OSHA- option is to obtain the prior approval of October 1, 2021)
approved State Plans for public the Secretary of Labor . . . [and] [i]t Arkansas S.B. 739. (2021, October 4). An Act
employers only. would make the state plan approval Concerning Employment Issues Related
Under section 18(c)(2) of the OSH requirement superfluous if a state could to Coronavirus 2019 (COVID–19); To
Act, State Plans are required to adopt pick and choose which occupational Provide Employee Exemptions From
and enforce occupational safety and health and safety regulations to submit Federal Mandates and Employer
to OSHA’’). Thus, a State or local Mandates Related to Coronavirus 2019
health standards that are at least as
(COVID–19); To Declare and Emergency;
effective as federal OSHA’s requirement banning or limiting
and For Other Purposes. https://
requirements. Id. section 667(c)(2). In employer vaccine mandates would www.arkleg.state.ar.us/Bills/
addition, the OSH Act requires that similarly be preempted because it has FTPDocument?path=%
State Plans must cover State and local not been approved by federal OSHA as 2FBills%2F2021R%
government employees (including, e.g., part of the State Plan. And, indeed, it 2FPublic%2FSB739.pdf. (Arkansas S.B.
State and local school systems within could not be approved by federal OSHA, 739, October 4, 2021)
the scope of this rule), even though because such bans or limitations Arkansas Governor Asa Hutchinson. (2021,
federal OSHA does not have coverage undercut the ETS’s requirements and October 13). Press Release: Governor
Hutchinson Allows Vaccine Mandate,
over such employees in States without are clearly not as effective as the federal
Redistricting Bills to Become Law
OSHA-approved State Plans. ETS. See 29 U.S.C. 667(c)(2).86 Without His Signature. https://governor.
Once OSHA promulgates an ETS, Finally, this provision includes a note arkansas.gov/news-media/press-
OSHA’s regulations provide that those that this section establishes minimum releases/governor-hutchinson-allows-
States have ‘‘30 days after the date of requirements for employers, that vaccine-mandate-redistricting-bills-to-
promulgation of the Federal standard to nothing in this section prevents become-la. (Governor Hutchinson,
employers from agreeing with their October 13, 2021)
84 In addition, some State and local governments employees to implement additional Baltimore City Health Department. (2021,
have adopted vaccination mandates directed at measures, and that this section does not August 10). Health Commissioner
State and/or local government employees. The OSH Updated Directive and Order for Face
Act and OSHA’s standards would not preempt such
supplant collective bargaining Coverings. https://www.baltimore
requirements since State or local government agreements or other collectively city.gov/sites/default/files/HEALTH%20
employers and employees are exempt from OSHA negotiated agreements in effect that may COMMISSIONER%
coverage under the OSH Act. 29 U.S.C. 652 (5) have negotiated terms that exceed the 20AUGUST%2010,%202021%
(defining employer to exclude ‘‘any State or
political subdivision of a State’’). However, many
requirements herein. It also references 20DIRECTIVE%20AND%
State and local government employers in States the National Labor Relations Act of 20ORDER%20FOR%
with OSHA-approved State Plans will be covered 1935, which protects most private-sector 20FACE%20COVERINGS_FINAL.pdf.
by State occupational safety and health employees’ right to take collective (Baltimore City Health Department,
requirements, and State Plans must adopt August 10, 2021)
requirements for State and local government
action. The purpose of this note is to Emergency Executive Order 225. (2021,
employers, as well as covered private sector remind employers and employees that August 16). Key to NYC: Requiring
employers, that are at least as effective as federal OSHA’s ETS establishes a floor for COVID–19 Vaccination for Indoor
OSHA’s requirements; State Plans may also choose protections, and that it does not Entertainment, Recreation, Dining and
to adopt more protective occupational safety and
health requirements. 29 U.S.C. 667(c).
preclude bargaining for additional Fitness Settings. https://www1.nyc.gov/
85 As previously discussed, bans on mandating protective measures. For example, office-of-the-mayor/news/225–001/
vaccinations or face coverings have not typically
emergency-executive-order-225. (NYC
been generally applicable, but even the least 86 For example, Arizona has an OSHA-approved Emergency Executive Order 225, August
workplace-specific, most generally applied bans State Plan, but its vaccination ban, which is not part 16, 2021)
will not survive preemption because they directly of its State Plan, is preempted by this ETS (see AZ Florida Executive Order 21–102. (2021, May
interfere with the ETS’s regulatory scheme. Executive Order 2021–18, Aug. 16, 2021). 3). https://www.flgov.com/wp-content/
App. 110
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61511
uploads/orders/2021/EO_21–102.pdf. generally covers employers in all public comment and seeking additional
(Florida Executive Order 21–102, May 3, workplaces that are under OSHA’s information to assess the ability of
2021) authority and jurisdiction, including smaller employers to do so in the
Hawai’i Emergency Proclamation Related to industries as diverse as manufacturing, rulemaking commenced by this ETS.
the State’s COVID–19 Delta Response.
(2021, October 1). https://governor. retail, delivery services, warehouses, OSHA will determine the issue on the
hawaii.gov/wp-content/uploads/2021/ meatpacking, agriculture, construction, basis of the record, after receiving
10/2109152–ATG_Emergency- logging, maritime, and healthcare. public comment.87 The SARS–CoV–2
Proclamation-Related-to-the-States- virus continues to spread rapidly, and
I. Decision To Limit Coverage of This
COVID–19-Delta-Response-distribution- each day that passes, tens of thousands
signed.pdf. (Hawai’i Emergency ETS to Employers With 100 or More
more people are infected. The
Proclamation, October 1, 2021) Employees
employees of larger firms should not
Illinois Executive Order 2021–20. (2021, This ETS applies to employers with a have to wait for the protections of this
August 26). https://www.illinois.gov/ total of 100 or more employees at any standard while OSHA takes the
government/executive-orders/executive- time the standard is in effect. In light of
order.executive-order-number-
additional time necessary to assess the
the unique occupational safety and feasibility of the standard for smaller
20.2021.html. (Illinois Executive Order
2021–20, August 26, 2021) health dangers presented by COVID–19, employers.
Marr C. (2021, October 7). Workplace and against the backdrop of the The pandemic has presented special
Vaccine Exemption Bills Sent to uncertain economic environment of a challenges for small businesses.
Arkansas Governor. Bloomberg Law. pandemic, OSHA established this According to a survey conducted during
https://news.bloomberglaw.com/daily- coverage threshold for four reasons. its early stages, 66% of businesses with
labor-report/workplace-vaccine- First, OSHA is confident that employers fewer than 100 employees had suffered
exemption-bills-sent-to-arkansas- with 100 or more employees will be able revenues losses exceeding 30%. (SHRM,
governor. (Marr, October 7, 2021) to meet the standard’s requirements May 6, 2020a). By contrast, only 27% of
Texas Executive Order GA–34. (2021, March promptly, as the emergency addressed larger businesses with more than 100
2). Executive Order No. GA–34 relating
by the standard necessitates. OSHA is employees had seen revenue drops of
to the opening of Texas in response to
the COVID–19 disaster. https:// less confident that smaller employers more than 30% (SHRM, May 6, 2020b).
open.texas.gov/uploads/files/ can do so without undue disruption. More recently, 61% of the members of
organization/opentexas/E.O.-GA–34- Second, this coverage threshold will the National Federation of Independent
opening-Texas-response-to-COVID- enable the standard to reach two-thirds Businesses, mostly very small
disaster-IMAGE–03–02–2021.pdf. (Texas of all private-sector workers in the businesses, responded to a survey
Executive Order GA–34, March 2, 2021) nation, providing them with prompt reported that they were experiencing
Texas Executive Order GA–36. (2021, May protection. Third, the standard will staff shortages, with half of that group
18). Executive Order No. GA–36 relating reach the largest facilities, where the reporting a moderate to significant loss
to the prohibition of governmental most deadly outbreaks of COVID–19 can of sales because of unfilled positions
entities and officials from mandating
occur. Fourth, the 100-employee (NFIB, July 12, 2021).
face coverings or restricting activities in
response to the COVID–19 disaster. threshold in this standard is comparable The requirements of the ETS could
https://gov.texas.gov/uploads/files/ with the size thresholds established by have a differential impact on small
press/E.O.-GA–36_prohibition_on_ congressional and agency decisions in businesses compared with larger firms.
mandating_face_coverings_response_to_ analogous contexts. Many small businesses lack separate
COVID–19_disaster_IMAGE_05–18– human resources departments and
a. Challenges to Feasibility Analysis for
2021.pdf. (Texas Executive Order GA– struggle to carry out HR functions. A
36, May 18, 2021) Small Businesses
study found that some 70% of small
Texas Executive Order GA–40. (2021, An OSHA standard, including an businesses (with 5 to 49 employees)
October 11). Executive Order No. GA–40 ETS, must be both economically and handle HR tasks in an ad hoc way.
relating to prohibiting vaccine mandates, technologically feasible. A standard is (ADP, December 2016). Only 23% of ad
subject to legislative action. https://
economically feasible under the OSH hoc managers believed they had the
gov.texas.gov/uploads/files/press/E.O.-
GA–40_prohibiting_vaccine_mandates_ Act if it neither threatens ‘‘massive tools and resources necessary to perform
legislative_action_IMAGE_10–11– dislocation to’’ nor upsets the HR tasks well, and only 19% were fully
2021.pdf. (Texas Executive Order GA– ‘‘competitive stability of’’ the regulated confident in their ability to handle HR
40, October 11, 2021) industries. United Steelworkers of Am., tasks without making mistakes (ADP,
AFL–CIO–CLC v. Marshall, 647 F.2d December 2016). Another survey found
B. Scope and Application 1189, 1265 (D.C. Cir. 1980). that HR functions are proportionally far
Paragraph (b)(1) of this ETS provides Technological feasibility has been more expensive for smaller firms than
that the ETS applies to all employers interpreted broadly to mean ‘‘capable of for larger (small firms defined as up to
that have a total of at least 100 being done’’ Am. Textile Mfrs. Inst. v. 250 workers) (SHRM, 2015). The ETS
employees at any time the ETS is in Donovan, 452 U.S. 490, 509–510 (1981). requires employers to establish new
effect. OSHA has determined that the As shown in Economic Analysis, systems to track vaccination status
unvaccinated employees of these Section IV.B. of this preamble, OSHA is among workers, to keep related records,
employers face a grave danger of confident that this standard is feasible and for firms that allow the testing
exposure to SARS–CoV–2, including the for employers with 100 or more option, to keep records of each test.
Delta variant, while they are at work employees. OSHA is not at this time
(see Grave Danger, Section III.A. of this making any determination about 87 If OSHA receives information suggesting that a
preamble). Because this grave danger whether it would be appropriate to broader scope would be appropriate, the agency
could expand the scope of the ETS quickly through
finding applies to all unvaccinated extend the ETS to cover smaller a supplemental action. Fla. Peach Growers Ass’n,
employees who come into contact with employers. Put simply, the agency is Inc. v. U. S. Dep’t of Labor, 489 F.2d 120, 127 (5th
other people in indoor work settings as requiring that employers it is confident Cir. 1974) (‘‘It is inconceivable that Congress,
can implement the provisions of the having granted the Secretary the authority to react
part of their employment, this ETS is quickly in fast-breaking emergency situations,
not limited by industrial sector or standard without delay do so. At the intended to limit his ability to react to
NAICS code. Therefore, this standard same time, the agency is soliciting developments subsequent to his initial response.’’)
App. 111
61512 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
These records must be treated as while still leaving many employees Health Authority, October 6, 2021;
confidential medical records subject to outside the standard. (U.S. Census CDPHE, October 6, 2021). A study of
detailed regulations, which is not Bureau, May 2021). outbreaks in Los Angeles County found
something most smaller employers that the median number of employees in
c. The ETS Will Help Prevent Large
typically need to do or have existing an establishment in which an outbreak
Outbreaks of COVID–19
systems in place to address. 29 CFR occurred was 95, well above the 50
1910.1020. While OSHA has imposed The ETS’s focus on employers with employee median for locations of
similar requirements on smaller more than 100 employees will also help employers covered by this rule,
employers before, it has typically done prevent large-scale outbreaks. As indicating that the rule will protect
so in highly regulated industries, such addressed in more detail in the employees in the places where
as healthcare, or in industries involving discussion of Grave Danger (Section outbreaks are most likely to occur.
complicated industrial processes, which III.A. of this preamble), all unvaccinated (Contreras et al., July, 2021). And those
already require a certain degree of employees who work in indoor settings outbreaks occurred even before the
administrative capacity even when not face a grave danger from COVID–19, emergence of the SARS–CoV–2 Delta
responding to a grave danger, through a which is why the scope of the ETS is variant, which the CDC says ‘‘causes
rulemaking process that provides not limited to worksites of a specific more infections and spreads faster than
additional time for notice and size. The standard is based on employer early forms of SARS–CoV–2.’’ (CDC,
implementation, and when there is size primarily because administrative August 26, 2021) In fact, the studies
more time to assess the impact that the capacity is more closely related to noted earlier in this paragraph were
standard would have on small business. employer size. In addition, employer published just as the Delta variant was
This emergency standard by contrast size provides a clear measure that is emerging, meaning that the risk of
applies across the board to all easy for employers (and OSHA) to track, transmission cited in those studies has
industries, including less regulated as opposed to an alternative such as a likely increased.
retail and service sectors. workplace-based approach, which could While virus transmission is certainly
Moreover, OSHA estimates that some fluctuate from day to day and mean not limited to large facilities, the
5% of employees may have a medical more places and information for the potential scope of an outbreak is
contraindication or request an employer to track. But OSHA also chose inherently more limited when fewer
accommodation from the rule’s the 100 employee size threshold in employees are present. In limiting the
requirements for disability or sincerely recognition of the fact that larger scope of the ETS to employers with 100
held religious belief reasons. (Please see employers are more likely to have many or more employees, OSHA is
Economic Analysis, Section IV.B. of this employees gathered in the same prioritizing coverage of those businesses
preamble). Assessing these requests may location. For employers with 100 or in which the spread of the virus could
require more resources for smaller firms more employees, the median number of potentially affect the largest number of
with less experience in this area, employees at any one location is employees and for which the agency is
particularly if they lack HR staff. By the approximately 50 (the average is also most confident that it is feasible to
same token, a delay in applying the ETS 50). (U.S. Census Bureau, May 2021). apply the standard.
to businesses with fewer than 100 For employers with fewer than 100
employees would allow those employees, the median number of any d. Analogous Regulatory Regimes Use
businesses the benefit of learning from one location is approximately 2 (with an Comparable Employee Size Thresholds
the models established by larger average number of 7) (U.S. Census Congress and federal agencies have
businesses with respect to Bureau, May 2021). frequently recognized that an employee
accommodations. Similarly, Employees at larger locations are size threshold may be appropriate in
implementing the ETS’s testing statistically more likely to be exposed to different regulatory contexts. They have
provisions in a stepwise fashion will someone with COVID–19 during the not settled on any one number as the
allow OSHA the time necessary to course of their shifts, and thus face a most appropriate, presumably because
assess any impact the new requirements heightened risk of virus transmission. that depends on balancing different
may have on the testing infrastructure Studies indicate that introduction of considerations that are relevant to the
and related supply chains before infection and the risk of infection particular context, as OSHA has done
considering extending those transmission is increased with the size here. But several analogous regulatory
requirements to additional employers. of a gathering (Champredon et al., April, regimes use employee size thresholds
2021), and with larger populations comparable to the one selected here, in
b. The ETS Provides Prompt Protection (Shacham et al., July 5, 2021). See also
for Most of America’s Workforce light of similar concerns about
(Contreras et al., July, 2021) (concluding administrative feasibility.
The 100 employee threshold means that outbreaks were larger and lasted For example, the EEOC has issued
the ETS will reach two-thirds of the longer at facilities with more onsite regulations requiring employers with
nation’s private sector workforce, staff). It is therefore not surprising that 100 or more employees to submit
providing protection to millions of significant COVID–19 outbreaks have annual reports related to equal
workers while issues regarding smaller occurred at large facilities of employers employment opportunity in their
firms are reviewed. OSHA considered with 100 or more employees 88 (Oregon workforce, in recognition that larger
that a 100 employee threshold was employers are better equipped to absorb
superior to a 150 employee threshold in 88 See, e.g., Oregon Health Authority, October 6,
the types of administrative burdens
this respect, because it would protect 2021, (publishing data on outbreaks in large
workplaces including two Amazon facilities,
more employees: 67% rather than 63%, several hospitals, and a Walmart distribution have little bearing on the statistical probability of
which is a difference of 4.856 million center); CDPHE, Oct. 6, 2021, (identifying an active exposure and transmission once the infected people
workers. (U.S. Census Bureau, May Covid outbreak in Cargill’s Fort Morgan, CO meat are together in the workplace with unvaccinated co-
2021). And while a 50 employee processing plant, which employs more than 2,000 workers. The most effective way to prevent further
workers). While some have speculated that clusters transmission is to protect the other workers through
threshold would have covered more of infections among employees at the same facility vaccination or, when that is not possible, identify
employees (78%), it would have might result initially from shared exposures outside and remove the infected workers from the
required additional feasibility analysis, of work, the original source of the infection would workplace as quickly as possible.
App. 112
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61513
imposed by surveying, tracking and smaller employers, and that a contractors do not. As discussed above,
recordkeeping requirements. See 42 comparable size threshold has been OSHA has not found that the standard
U.S.C. 2000e–8(c), 29 CFR 1602.7–.14 found appropriate in similar contexts. is feasible for firms with fewer than 100
and 41 CFR 60–1.7(a). In earlier Where employees are dying every day, employees, because it needs additional
measures adopted in response to the it is not unreasonable for the agency to time to assess the impact of the standard
COVID–19 pandemic, Congress adopted prioritize doing what it can to address on these employers, particularly as
special protections and exemptions the problem quickly, regardless of many smaller firms lack separate human
based on employee counts. The Families whether there are further actions it resources departments and may face
First Coronavirus Response Act, Public might be able to take later. additional challenges when carrying out
Law 116–127 (2020), sections 7001 and Doing so implements the statutory human resources functions. In contrast,
7003 provided tax credits to businesses delegation of authority to the agency to OSHA has determined that the standard
with fewer than 500 employees to assist establish priorities for issuing standards is feasible for firms with 100 or more
compliance with the Act’s expansion of by giving ‘‘due regard to the urgency of employees, regardless of where those
paid sick and family leave, in the need’’ for standards for particular employees report to work. These firms
recognition of the challenges facing workplaces. 29 U.S.C. 655(g). The courts generally have greater administrative
smaller employers. Congress again have recognized that this provision capacities, and including all such
relied on the same 500 employee authorizes the Secretary to make employers in the scope of this ETS
threshold when it later extended tax reasonable decisions limiting the scope ensures that OSHA can cover two-thirds
credits only to employers who granted of a standard, particularly where as here of all workers in the private sector as
employees paid time off to be the agency has said it will address the quickly as possible.
vaccinated, implicitly acknowledging reserved issue in subsequent For a single corporate entity with
the financial obstacles that can exist for rulemaking. Forging Indus. Assoc. v. multiple locations, all employees at all
smaller employers for the same activity Donovan, 773 F.2d 1436, 1454 (4th Cir. locations are counted for purposes of
that this ETS promotes (and without the 1985) (hearing conservation standard); the 100-employee threshold for coverage
vaccine policy and verification United Steelworkers of Am. v. Marshall, under this ETS. In a traditional
requirement in this ETS). American 647 F.2d 1189, 1309–1310 (D.C. Cir. franchisor-franchisee relationship in
Rescue Plan Act, Public Law 117–2, Sec. 1980) (lead standard). which each franchise location is
9641 (2021). Where competing considerations are independently owned and operated, the
In the Affordable Care Act, Congress in play and there is no clear perfect franchisor and franchisees would be
set the maximum size of a ‘‘small choice, OSHA has a degree of discretion separate entities for coverage purposes,
employer’’ at 100 employees for to draw a reasonable line. Courts have such that the franchisor would only
purposes of allowing greater flexibility consistently recognized that agencies count ‘‘corporate’’ employees, and each
to these employers. 42 U.S.C.A. have discretion to draw reasonable franchisee would only count employees
18024(b)(3). Likewise, private lines. As the D.C. Circuit has explained: of that individual franchise. In other
employers with fewer than 50 An agency has ‘‘wide discretion’’ in situations, two or more related entities
employees are exempt from complying making line-drawing decisions and may be regarded as a single employer
with the Family and Medical Leave Act, ‘‘[t]he relevant question is whether the for OSH Act purposes if they handle
in recognition of smaller employers’ agency’s numbers are within a zone of safety matters as one company, in which
decreased administrative capacity, as reasonableness, not whether its numbers case the employees of all entities
well as their inability to easily are precisely right.’’ WorldCom, Inc. v. making up the integrated single
accommodate employee absences. 29 FCC, 238 F.3d 449, 462 (D.C. Cir. 2001) employer must be counted.
U.S.C.A. 2611(2)(b)(2). (quotation marks omitted). An agency In scenarios in which employees of a
‘‘is not required to identify the optimal staffing agency are placed at a host
e. The 100 Employee Coverage employer location, only the staffing
threshold with pinpoint precision. It is
Provision Is a Reasonable Exercise of the agency would count these jointly
only required to identify the standard
Secretary’s Authority employed workers for purposes of the
and explain its relationship to the
OSHA’s choice of a 100 employee underlying regulatory concerns.’’ Id. at 100-employee threshold for coverage
threshold is based on balancing the 461–62. Nat’l Shooting Sports Found. v. under this ETS. Although the staffing
fundamentally incommensurable Jones, 716 F.3d. 200, 214–215 (D.C. Cir agency and the host employer would
considerations described above. Under 2013). See also Providence Yakima Med. normally share responsibility for these
the statute OSHA ‘‘shall’’ issue an ETS Ctr. v. Sebelius, 611 F.3d 1181, 1190– workers under the OSH Act, this ETS
when employees are exposed to grave 1191 (9th Cir. 2010). raises unique concerns in that OSHA
danger, and is not to follow normal For the reasons discussed above, the has set the threshold for coverage based
notice and comment procedures to build balance the agency struck here falls well primarily on administrative capacity for
a record. 29 U.S.C. 655(e). But OSHA within this zone of reasonableness. purposes of protecting workers as
may not issue an ETS unless it shows quickly as possible, as discussed above,
that the rule is feasible for the II. Explanation of Who Is Included in and the staffing agency would typically
employers covered, and it has not yet the 100-Employee Threshold handle administrative matters for these
made a feasibility determination for The applicability of this ETS is based workers. Thus, for purposes of the 100-
smaller employers. In the circumstances on the size of an employer, in terms of employee threshold, only the staffing
of this case, OSHA considered that an number of employees, rather than on the agency would count the jointly
ETS was urgently needed to protect type or number of workplaces. In employed employees. The host
employees, that a 100 employee determining the number of employees, employer, however, would still be
threshold would protect the great employers must include all employees covered by this ETS if it has 100 or more
majority of them and prevent the largest across all of their U.S. locations, employees in addition to the employees
outbreaks, that it would avoid the regardless of employees’ vaccination of the staffing agency. For enforcement
delays that would be needed if the status or where they perform their work. purposes, traditional joint employer
agency were required to gather Part-time employees do count towards principles would apply where both
information and analyze feasibility for the company total, but independent employers are covered by the ETS, as
App. 113
61514 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
illustrated further by the examples • If an employer has 200 employees, unlikely to make them less capable of
below. See also https://www.osha.gov/ all of whom are vaccinated, that compliance.
temporaryworkers/. employer would be covered. The determination of whether an
On a typical multi-employer worksite • If an employer has 125 employees, employer falls within the scope of this
such as a construction site, each and 115 of them work exclusively ETS based on number of employees
company represented—the host outdoors, that employer would be should initially be made as of the
employer, the general contractor, and covered. effective date of the standard, as set out
each subcontractor—would only need to • If a single corporation has 50 small in paragraph (m)(1). If the employer has
count its own employees, and the host locations (e.g., kiosks, concession 100 or more employees on the effective
employer and general contractor would stands) with at least 100 total employees date, this ETS applies for the duration
not need to count the total number of in its combined locations, that employer of the standard. If the employer has
workers at each site. That said, each would be covered even if some of the fewer than 100 employees on the
employer must count the total number locations have no more than one or two effective date of the standard, the
of workers it employs regardless of employees assigned to work there. standard would not apply to that
where they report for work on a • If a host employer has 80 employer as of the effective date.
particular day. Thus, for example, if a permanent employees and 30 temporary However, if that same employer
general contractor has more than 100 employees supplied by a staffing subsequently hires more workers and
agency, the host employer would not hits the 100-employee threshold for
employees spread out over multiple
count the staffing agency employees for coverage, the employer would then be
construction sites, that employer is
coverage purposes and therefore would expected to come into compliance with
covered under this ETS even if it does
not be covered. (So long as the staffing the standard’s requirements. Once an
not have 100 or more employees present
agency has at least 100 employees, employer has come within the scope of
at any one worksite. Covering the
however, the staffing agency would be the ETS, the standard continues to
employees of larger employers at multi-
responsible for ensuring compliance apply for the remainder of the time the
employer worksites would mitigate the
with the ETS for the jointly employed standard is in effect, regardless of
spread of COVID–19 at the workplace
workers.) fluctuations in the size of the
even where not all employees are
• If a host employer has 110 employer’s workforce. For example, an
covered by this ETS because fully
permanent employees and 10 temporary employer that has 103 employees on the
vaccinated employees (or unvaccinated
employees from a small staffing agency effective date of the standard, but then
employees wearing face coverings and
(with fewer than 100 employees of its loses four within the next month, would
submitting to weekly testing) would be
own), the host employer is covered continue to be covered by the ETS.
less likely to spread the virus to
under this ETS and the staffing agency OSHA is confident that employers with
unvaccinated workers at the site who
is not. 100 or more employees at any point
are not covered by this ETS.
• If a host employer has 110 while this ETS is in effect have the
The determination as to whether a administrative capacity to comply with
particular employer is covered by the permanent employees and 10 employees
from a large staffing agency (with more the ETS, even if the number of
standard should be made separately employees fluctuates somewhat above
from whether individual employees are than 100 employees of its own), both the
host employer and the staffing agency and below 100.
covered by the standard’s requirements, Paragraph (b)(2) of this ETS sets forth
as described by paragraph (b)(3) (e.g., are covered under this standard, and
two exemptions to the standard.89
some employers may be covered but traditional joint employer principles
Under paragraph (b)(2)(i), this ETS does
have no duties with respect to some of apply.
not apply to workplaces covered by the
their employees under this standard). • Generally, in a traditional
Safer Federal Workforce Task Force
Some additional examples include: franchisor-franchisee relationship, if the
COVID–19 Workplace Safety: Guidance
• If an employer has 75 part-time franchisor has more than 100 employees
for Federal Contractors and
employees and 25 full-time employees, but each individual franchisee has fewer
Subcontractors (see Safer Federal
the employer would be within the scope than 100 employees, the franchisor
Workforce Task Force, September 24,
of this ETS because it has 100 would be covered by this ETS but the
2021). With limited exceptions, such as
employees. individual franchises would not be
where a medical contraindication,
covered.
• If an employer has 150 employees, disability, or sincerely held religious
As explained earlier, part of OSHA’s
100 of whom work from their homes belief would prevent an employee from
rationale in adopting the 100-employee
full-time and 50 of whom work in the complying with certain provisions,
threshold is to focus the ETS on
office at least part of the time, the those guidelines require covered
companies that OSHA is confident will
employer would be within the scope of have sufficient administrative systems 89 Note that, in addition to the scope exceptions
this ETS because it has more than 100 in place to comply quickly with the contained in the ETS itself, which are discussed in
employees. ETS. Thus, the ETS applies to all this section, there may be situations where the ETS
• If an employer has 102 employees employers who have the requisite does not apply by operation of the OSH Act. For
and only 3 ever report to an office example, the OSH Act does not apply to working
number of employees at any time this conditions of employees with respect to which
location, that employer would be ETS is in effect. Along with employers other Federal agencies have exercised their
covered. that always have more than 100 statutory authority to prescribe or enforce standards
• If an employer has 150 employees, employees, OSHA intends to cover or regulations affecting occupational safety or
health (see 29 U.S.C. 653(b)(1)). Moreover, the ETS
and 100 of them perform maintenance employers that fluctuate above and does not apply where states with OSHA-approved
work in customers’ homes, primarily below the 100-employee threshold occupational safety and health programs (‘‘State
working from their company vehicles during the term of the ETS because Plans’’) have coverage (see 29 U.S.C. 667). State
(i.e., mobile workplaces), and rarely or those employers will typically have Plans must adopt and enforce COVID–19
requirements that are at least as effective as this
never report to the main office, that already developed systems and ETS. Finally, the ETS does not apply to state and
employer would also fall within the capabilities for compliance; a decrease local government employers in states without State
scope. in the number of employees is therefore Plans (see 29 U.S.C. 652(5)).
App. 114
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61515
contractors to ensure that all covered are consistent with the ETS’s (see Safer ambulatory care clinics embedded in its
contractor employees (1) are fully Federal Workforce Task Force, October stores, where those embedded clinics
vaccinated by December 8, 2021; (2) 11, 2021). Note, however, that under the are the only areas in the store that are
follow CDC guidelines for masks and OSH Act, the U.S. Postal Service is covered under 1910.502 (see section
physical distancing, including masking treated as a private employer, see 29 1910.502(a)(3)(i)), would have to ensure
and distancing requirements based on U.S.C. 652(5), and it is therefore that the remainder of its employees in
the employee’s vaccination status and required to comply with this ETS in the other parts of its stores are protected
the level of community transmission of same manner as any other employer under this ETS if the company has 100
COVID–19 where the workplace is covered by the Act. or more employees company-wide,
located; and (3) designate a person to For similar reasons, paragraph including those covered under
coordinate COVID–19 workplace safety (b)(2)(ii) provides that this ETS does not 1910.502.
efforts at covered workplaces. Because apply in settings where any employee Paragraph (b)(3) provides that, even
covered contractor employees are provides healthcare services or where the standard applies to a
already covered by the protections in healthcare support services while they particular employer, its requirements do
those guidelines, OSHA has determined are covered by the requirements of 29 not apply to employees: (i) Who do not
that complying with this standard in CFR 1910.502. Section 1910.502 report to a workplace where other
addition to the federal contractor requires a multi-layered suite of individuals such as coworkers or
guidelines is not necessary to protect protections for employees covered by its customers are present; (ii) while
covered contractor employees from a requirements, including patient working from home; or (iii) who work
grave danger posed by COVID–19. screening and management, facemasks exclusively outdoors. OSHA intends
Although there may be some respects in or respirators, other personal protective these provisions to exempt workplace
which the OSHA standard is somewhat equipment (PPE), limiting exposure to settings where workers do not interact
more protective, such as providing paid aerosol-generating procedures, physical indoors with other individuals, and to
leave for vaccination, the federal distancing, physical barriers, cleaning, exempt work performed in the
contractor guidelines are somewhat disinfection, ventilation, health employee’s home regardless of whether
more protective in other respects, such screening and medical management, other individuals may be present in the
as requiring vaccination for everyone access to vaccination, and medical home.
who does not have a right to an removal protection. Section 1910.502 OSHA has determined that the
accommodation rather than allowing was carefully tailored to the healthcare provisions of this ETS are not necessary
employees to submit to testing in lieu of workplaces it covers and, given the full to protect employees from COVID–19
vaccination. In essence, they are similar suite of protections it requires, when they are working alone, or when
including (like this ETS) the provision they are working from home (see Grave
but slightly different schemes that
of paid time for vaccination, OSHA has Danger, Section III.A. of this preamble).
provide roughly equivalent protection,
determined that it adequately protects These two provisions may overlap in
and OSHA has determined that
the employees covered by its some cases, but also can apply to
imposing a second set of similar
requirements from the grave danger slightly different situations. Paragraph
protections on covered federal
posed by COVID–19. Therefore, (b)(3)(i) would apply to work in a
contractors by subjecting them to this
complying with the additional solitary location, such as a research
ETS in addition to the federal contractor
requirements of this ETS is not station where only one person (the
guidance is not necessary at this time to
necessary to protect those employees employee) is present at a time. In that
reduce a grave danger to covered
while they are covered by that situation, the employee is not exposed
contractor employees from COVID–19. to any potentially infectious individuals
standard’s protections.
Under Executive Order 14043, every OSHA’s intent was to leave no at work. Paragraph (b)(3)(ii) would
federal agency must implement a coverage gaps between section 1910.502 apply to employees working in their
program requiring each of its federal and this ETS. In other words, the homes, regardless of whether other
employees to be vaccinated against purpose of paragraph (b)(2)(ii) is to individuals who are not employees of
COVID–19, except as required by law. ensure that all workers in healthcare the same employer are present. In a
86 FR 50989. OSHA will regard a and healthcare support jobs who are at home telework environment, many
federal agency’s compliance with this grave danger from exposure to SARS- factors—such as the presence of family
requirement, and the related Safer CoV–2 are protected by either section members and other individuals
Federal Workforce Task Force guidance 1910.502 or this ETS while performing unrelated to the employee’s work, who
issued under section 4(e) of Executive their jobs. Therefore, it will be necessary may not be fully vaccinated or wearing
Order 13991 and section 2 of Executive for employers with employees covered face coverings—may be beyond the
Order 14043 (including guidance on by section 1910.502 to determine if they employer’s control. Employees are
employer support in the form of paid also have employees covered by this typically in the best position to manage
time for vaccination and paid leave for ETS. For example, a healthcare COVID–19 risks in their homes. Note
post-vaccination recovery), as sufficient employer with more than 100 that the exemption in paragraph
to meet its obligation to comply with employees that has non-hospital (b)(3)(ii) only applies to employees
this ETS under Section 19 of the OSH ambulatory care facilities that are while they are working from home. An
Act and Executive Order 12196. In exempt under section 1910.502(a)(2)(iii) employee who switches back and forth
essence, the federal government has (for non-hospital ambulatory care from teleworking to working in a setting
chosen the mandatory vaccination settings where all non-employees are where other people are present (e.g., an
option of this rule, and all federal screened prior to entry and those with office) is covered by this ETS and must
employees are required to be fully suspected or confirmed COVID–19 are be vaccinated if required by the
vaccinated by the compliance date of prohibited from entry) would be employer. If the employer does not
this standard, except where entitled to required to protect the employees in require vaccination, the teleworking
a reasonable accommodation. The Safer those ambulatory care facilities under employee must either be vaccinated or
Federal Workforce Task Force’s this ETS. Similarly, a retail pharmacy complete testing and wear a face
guidelines for vaccination verification chain that operates a series of covering in accordance with their
App. 115
61516 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
employer’s policy under paragraph (d). exemptions in paragraph (b)(2), the Workplaces that are truly outdoors
How often such an employee must be standard applies to that employer even typically do not include any of the
tested for COVID–19 and wear a face if a majority of the company’s characteristics that normally enable
covering, however, depends on how employees work exclusively outdoors. transmission of SARS–CoV–2 to occur,
often they report to the office (see, e.g., The standard’s protections would only such as poor ventilation, enclosed
paragraph (g)(1)(ii)). apply to employees working in indoor spaces, and crowding. As discussed in
Paragraph (b)(3)(iii) provides that, settings around other individuals (other Bulfone et al. (November 29, 2020), the
even if a particular employer is covered than telework in their own homes), not lower risk of transmission in outdoor
by the standard, the requirements of the to those employees working exclusively settings (i.e., open air or structures with
standard do not apply to employees outdoors. In some cases, it may be true only one wall) is likely due to increased
who work exclusively outdoors. OSHA that the standard applies to an employer ventilation with fresh air and a greater
has determined that COVID–19 does not but the employer would not have to ability to maintain physical distancing
pose a grave danger to employees who implement its provisions at all because (see Grave Danger, Section III.A. of this
work exclusively outdoors because of all of its employees fall within preamble, for more information on risk
the significantly reduced likelihood of exemptions in paragraph (b)(3). Going of transmission outdoors).
transmission in outdoor settings. As back to the example of the large
discussed in more detail in Grave landscaping contractor, if all indoor References
Danger (Section III.A. of this preamble), workers either work from home or in Always Designing for People (ADP). (2016,
the record contains very little evidence locations where no other individuals are December). Opportunity is calling.
of COVID–19 transmission in outdoor present, and all outdoors workers work Answer it. Insights and solutions for
settings. And, in studies where clusters exclusively outdoors and do not drive to moving beyond risky ad hoc HR
were identified in worksites worksites together in a company management. (ADP, December 2016)
characterized as being outdoors, the Bulfone TC et al. (2020, November 29).
vehicle, the employer would be covered Outdoor Transmission of SARS-CoV–2
study authors were not able to identify by the ETS but not required to comply and Other Respiratory Viruses: A
specific incidents that led to with its provisions. Systematic Review. (2020). The Journal
transmission. In addition, workplaces An employee will only be covered by of Infectious Diseases 223: 550–561.
characterized as ‘‘outdoors’’ may in fact the exemption in paragraph (b)(3)(iii) if https://doi.org/10.1093/infdis/jiaa742.
involve significant time spent indoors. the employee works exclusively (Bulfone et al., November 29, 2020)
For example, on a construction site, outdoors. Thus, an employee who works Centers for Disease Control and Prevention
workers inside a partially complete indoors on some days and outdoors on (CDC). (2021, August 26). Delta Variant:
structure are not truly outdoors, and other days would not be exempt from What We Know About the Science.
some individuals on a construction site the requirements of this ETS. Likewise, https://www.cdc.gov/coronavirus/2019-
ncov/variants/delta-variant.html?s_
may spend significant amounts of time if an employee works primarily
cid=11512:cdc%20delta%20variant:sem.
in a construction trailer where other outdoors but routinely occupies ga:p:RG:GM:gen:PTN:FY21. (CDC,
individuals are present. Workers at vehicles with other employees as part of August 26, 2021)
outdoor locations may also routinely work duties, that employee is not Champredon D et al. (2021, May 12).
share work vehicles. These indoor covered by the exemption in paragraph Modelling approach to assessing risk of
exposures could account for COVID–19 (b)(3)(iii). However, if an employee transmission of SARS-CoV–2 at
clusters among employees at worksites works outdoors for the duration of every gatherings. https://www.canada.ca/en/
otherwise characterized as being workday except for de minimis use of public-health/services/reports-
outdoors. And employees whose indoor spaces where other individuals publications/canada-communicable-
outdoor time is interrupted by the may be present—such as a multi-stall disease-report-ccdr/monthly-issue/2021-
47/issue-4-april-2021/assessing-risk-
indoor periods will still be subject to the bathroom or an administrative office—
transmission-sars-cov-2-gatherings.html.
requirements in this ETS. that employee would be considered to (Champredon et al., May 12, 2021)
Studies of athletic teams further work exclusively outdoors and covered Colorado Department of Public Health and
indicate that evidence of COVID–19 by the exemption under paragraph Environment (CDPHE). (2021, October
clusters among workers characterized as (b)(3)(iii) as long as time spent indoors 6). CDPHE COVID–19 outbreak map
working outdoors could actually be is brief, or occurs exclusively in the updated October 6, 2021. https://
caused by indoor exposures. Even employee’s home (e.g., a lunch break at cdphe.maps.arcgis.com/apps/
where athletes were in very close home). Extremely brief periods of webappviewer/index.html?id=
contact during outdoor exposures on the indoor work would not normally expose dcc0b993632a4bc68dc7b9a1dd015cfe.
playing field, the study authors could employees to a high risk of contracting (CDPHE, October 6, 2021)
not identify a single case of COVID–19 Contreras Z et al. (2021, July). Industry
COVID–19; however, OSHA will look at
Sectors Highly Affected by Worksite
transmission between teams that cumulative time spent indoors to Outbreaks of Coronavirus Disease, Los
occurred outdoors (see Mack et al., determine whether that time is de Angeles County, California, USA, March
January 29, 2021; Egger et al., March 18, minimis. Thus, if there are several brief 19-September 30, 2020. Emerg Infect Dis.
2021; Jones et al., February 11, 2021). periods in a day when an employee goes 2021; 27(7): 1769–1775. doi:10.3201/
For all of these reasons, and as inside, OSHA will total those periods of eid2707.210425. (Contreras et al., July,
discussed more fully in Grave Danger time when determining whether the 2021)
(Section III.A. of this preamble), OSHA exception for exclusively outdoors work Egger F et al. (2021, March 18). Does playing
has determined that COVID–19 does not applies. football (soccer) lead to SARS–CoV–2
pose a grave danger to employees who Finally, to qualify for this exception, transmission?—a case study of 3 matches
work exclusively outdoors. the employee’s work must truly occur with 19 infected football players. Science
and Medicine in Football. doi:10.1080/
As a practical matter, determining the ‘‘outdoors,’’ which would not include
24733938.2021.1895442. (Egger et al.,
applicability of paragraph (b)(3)(iii) buildings under construction where March 18, 2021)
depends on the working conditions of substantial portions of the structure are Jones B et al. (2021, February 11). SARS–
individual employees. For example, if a in place, such as walls and ceiling CoV–2 transmission during rugby league
landscaping contractor has at least 100 elements that would impede the natural matches: do players become infected
employees and is not covered by the flow of fresh air at the worksite. after participating with SARS–CoV–2
App. 116
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61517
positive players? Br J Sports Med and states, NAICS sector,’’ https:// COVID–19 tests can broadly be
doi:10.1136/bjsports-2020–103714. www.census.gov/data/tables/2017/econ/ divided into two categories, diagnostic
(Jones et al., February 11, 2021) susb/2017-susb-annual.html. (US Census tests and antibody tests. Diagnostic tests
Mack CD et al. (2021, January 29). Bureau, May 2021) detect parts of the SARS–CoV–2 virus
Implementation and evolution of
mitigation measures, testing, and contact C. Definitions and can be used to diagnose current
tracing in the national football league, infection. On the other hand, antibody
Paragraph (c) of the ETS provides
August 9–November 21, 2020. MMWR tests look for antibodies in the immune
definitions of terms used in the section.
70: 130–135. doi:http://dx.doi.org/ system produced in response to SARS–
‘‘Assistant Secretary’’ means the
10.15585/mmwr.mm7004e2. (Mack et al., CoV–2, and are not used to diagnose an
January 29, 2021)
Assistant Secretary of Labor for
active COVID–19 infection. Antibody
National Federation of Independent Business Occupational Safety and Health, U.S.
tests do not meet the definition of
(NFIB) Research Center. (2021, July 12). Department of Labor, or designee. This
COVID–19 test for the purposes of this
Covid-19 small business survey (18): definition provides clarification about
ETS.
federal small business programs, the who can request and receive records Diagnostic tests for current infection
vaccine, labor shortage, and supply specified in paragraph (l)(3) of this
chain disruptions. https:// fall into two categories: Nucleic acid
section. A designee includes a amplification tests (NAATs) and antigen
assets.nfib.com/nfibcom/Covid-19-18- representative conducting an inspection
Questionnaire.pdf. (NFIB, July 12, 2021) tests. NAATs are a type of molecular
Oregon Health Authority. (2021, October 6).
or an investigation. test that detect genetic material (nucleic
COVID–19 weekly outbreak report— ‘‘COVID–19 (Coronavirus Disease acids); NAATs for COVID–19 identify
October 6, 2021. https:// 2019)’’ means the disease caused by the ribonucleic acid (RNA) sequences
www.oregon.gov/oha/covid19/ SARS–CoV–2 (severe acute respiratory that comprise the genetic material of the
Documents/DataReports/Weekly- syndrome coronavirus 2). SARS–CoV–2 virus. NAATs can reliably detect small
Outbreak-COVID-19-Report.pdf. (Oregon is a highly transmissible virus that amounts of SARS–CoV–2 and are
Health Authority, October 6, 2021) spreads primarily through the
Safer Federal Workforce Task Force. (2021, unlikely to return a false-negative result.
respiratory droplets that are produced NAATs use many different methods to
September 24). COVID–19 Workplace when an infected person coughs,
Safety: Guidance for Federal Contractors detect the virus, including reverse
sneezes, sings, talks, or breathes. The transcription-polymerase chain reaction
and Subcontractors. https://
www.saferfederal/workforce./gov/ nature of the disease, variants of SARS– (RT–PCR), which is a high-sensitivity,
downloads/Draft%/20contractor%/ CoV–2, disease transmission, and high-specificity 90 test for diagnosing
20guidance%/20doc_20210922.pdf. associated health effects are all SARS–CoV–2 infection. Other types of
(Safer Federal Workforce Task Force, described in great detail in Grave NAATs that use isothermal
September 24, 2021) Danger (Section III.A. of this preamble). amplification methods include nicking
Safer Federal Workforce Task Force. (2021, For clarity and ease of reference, the endonuclease amplification reaction
October 11). Vaccinations: Vaccination ETS also uses the term ‘‘COVID–19’’
Documentation and Information. https:// (NEAR), transcription mediated
when describing exposures or potential amplification (TMA), loop-mediated
www.saferfederalworkforce.gov/faq/
exposures to SARS–CoV–2. The isothermal amplification (LAMP),
vaccinations/. (Safer Federal Workforce
Task Force, October 11, 2021) requirements of the ETS are intended to helicase-dependent amplification
Shacham E et al. (2021, July 5). Examining address the grave danger of exposure to (HDA), clustered regularly interspaced
the relationship between COVID–19 COVID–19 in the workplace. short palindromic repeats (CRISPR), and
vaccinations and reported incidence. A ‘‘COVID–19 test’’ means a test for strand displacement amplification
doi:https://doi.org/10.1101/ SARS–CoV–2 that is: (1) Cleared, (SDA) (CDC, June 14, 2021).
2021.06.30.21259794. (Shacham et al., approved, or authorized, including in an Most NAATs need to be processed in
July 5, 2021) Emergency Use Authorization (EUA), by a laboratory with variable time to
Society for Human Resource Management the U.S. Food and Drug Administration receive results (approximately 1–2
(SHRM). (2015). How organizational staff (FDA) to detect current infection with
size influences HR metrics. https:// days), but some NAATs are point-of-
www.shrm.org/resourcesandtools/
the SARS–CoV–2 virus (e.g., a viral care tests with results available in about
business-solutions/documents/ test); (2) administered in accordance 15–45 minutes. As of October 14, 2021,
organizational%20staff%20size.pdf. with the authorized instructions; and (3) 264 molecular tests (NAATs) and
(SHRM, 2015) not both self-administered and self-read collection devices have EUA from the
Society for Human Resource Management unless observed by the employer or an FDA for COVID–19 (FDA, October 14,
(SHRM). (2020a, May 6). Navigating authorized telehealth proctor. Examples 2021b). These tests may be acceptable
COVID–19: impact of the pandemic on of tests that satisfy this requirement under the ETS.
small businesses. https://shrm.org/hr- include tests with specimens that are Antigen tests may also meet the
today/trends-and-forecasting/research- processed by a laboratory (including definition of COVID–19 test under this
andsurveys/Documents/
SHRM%20CV19%20SBO%20Research%
home or on-site collected specimens standard. Antigen tests indicate current
20Presentation%20v1.1.pdf. (SHRM, which are processed either individually infection by detecting the presence of a
May 6, 2020a) or as pooled specimens), proctored over- specific viral antigen. Most can be
Society for Human Resource Management the-counter tests, point of care tests, and processed at the point of care with
(SHRM). (2020b, May 6). Survey: tests where specimen collection and results available in about 1530 minutes.
COVID–19 could shutter most small processing is either done or observed by Antigen tests generally have similar
businesses. https://www.shrm.org/about- an employer. specificity to, but are less sensitive than,
shrm/press-room/press-releases/pages/ Under paragraph (g), employees who NAATs (CDC, October 7, 2021). As of
survey-covid-19-could-shutter-most- are not fully vaccinated must be tested October 14, 2021, thirty-seven antigen
small-businesses.aspx. (SHRM, May 6,
for COVID–19. When an employee must
2020b)
United States (US) Census Bureau. (2021, be tested, the test is considered 90 Test sensitivity indicates the ability of a test to
acceptable only if the test and the correctly identify people who have a disease. Test
May). 2017 SUSB Annual Data Tables by specificity indicates the ability of a test to correctly
Establishment Industry, The annual data administration of the test satisfy the identify people who do not have a disease. A test
table titled ‘‘U.S. & states, NAICS, definition of COVID–19 test in this with high sensitivity and high specificity minimizes
detailed employment sizes U.S., 6-digit standard. inaccurate results.
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61518 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
tests have EUA from the FDA for may simply require that employees will provide effective source control and
COVID–19 (FDA, October 14, 2021a). perform and read their own OTC test some degree of personal protection.
These tests may be acceptable under the while an authorized employee observes Source control means reducing the
ETS. the administration and reading of the spread of large respiratory droplets to
Most antigen tests and some NAATs test to ensure that a new test kit was others by covering a person’s mouth and
are conducted at the point of care, used and that the test was administered nose. The personal protection afforded
which means the test processing and properly (e.g., nostrils were swabbed), by face coverings, as well as the benefits
result reading is performed at or near and to witness the test result. and necessity, are described in the
the place where a specimen is collected Due to the potential for employee Summary and Explanation for
so that results can be obtained within misconduct (e.g., falsified results), tests paragraph (i) (Section VI.I. of this
minutes rather than hours or days. that are both self-administered and self- preamble).
Rapid point-of-care tests are read are not acceptable unless they are Face coverings differ from facemasks
administered in various settings observed by the employer or an and respirators, which are also defined
operating under a Clinical Laboratory authorized telehealth proctor. Some in paragraph (c) of this section. Face
Improvement Amendments of 1988 COVID–19 tests are authorized by the coverings, unlike facemasks and
(CLIA) certificate of waiver, such as FDA to be performed only with the respirators, are not considered to be
physician offices, urgent care facilities, supervision of a telehealth proctor, personal protective equipment (PPE)
pharmacies, school health clinics, which is someone who is trained to under OSHA’s general PPE standard (29
workplace health clinics, long-term care observe sample collection and provide CFR 1910.132), as discussed in the
facilities and nursing homes, and at instructions and result interpretation Summary and Explanation for
temporary locations, such as drive- assistance to individuals using the test. paragraph (i) (Section VI.I. of this
through sites managed by local health The term ‘‘authorized telehealth preamble).
organizations (FDA, November 16, proctor’’ refers to proctors who follow Lastly, face coverings as required by
2020). the requirements for proctoring this standard do not have to meet a
To be a valid COVID–19 test under specified by the FDA authorization. For consensus standard, although face
this standard, a test may not be both a more detailed discussion on COVID– coverings that adhere to such consensus
self-administered and self-read unless 19 testing requirements under this ETS, standards, with design and construction
observed by the employer or an see the Summary and Explanation for specifications, meet the definition and
authorized telehealth proctor. OSHA paragraph (g) (Section VI.G. of this may offer both greater protection and
included the requirement for some type preamble). the confidence that at least a minimum
of independent confirmation of the test A ‘‘face covering’’ means a covering level of protection has been provided.
result in order to ensure the integrity of that: (1) Completely covers the nose and The National Institute for Occupational
the result given the ‘‘many social and mouth; (2) is made with two or more Safety and Health (NIOSH) recommends
financial pressures for test-takers to layers of a breathable fabric that is that employers and workers who want
misrepresent their results’’ (Schulte et tightly woven (i.e., fabrics that do not let a face covering that provides a known
al., May 19, 2021). This independent light pass through when held up to a level of protection use face coverings
confirmation can be accomplished in light source); (3) is secured to the head that meet a new standard, called
multiple ways, including through the with ties, ear loops, or elastic bands that Workplace Performance and Workplace
involvement of a licensed healthcare go behind the head. If gaiters are worn, Performance Plus masks, for
provider or a point-of-care test provider. they should have two layers of fabric or workplaces. As discussed in the
If an over-the-counter (OTC) test is be folded to make two layers; (4) fits Summary and Explanation for
being used, it must be used in snugly over the nose, mouth, and chin paragraph (i) (Section VI.I. of this
accordance with the authorized with no large gaps on the outside of the preamble), the new NIOSH criteria and
instructions. The employer can validate face; and (5) is a solid piece of material the ASTM Specification for Barrier Face
the test through the use of a proctored without slits, exhalation valves, visible Coverings, F3502–21 (ASTM Standard)
test that is supervised by an authorized holes, punctures, or other openings. provide a greater level of source control
telehealth provider. Alternatively, the This definition includes clear face performance for workers when wearing
employer could proctor the OTC test coverings or cloth face coverings with a the face covering according to
itself. clear plastic panel that, despite the non- manufacturer’s instructions. The NIOSH
Employers have the flexibility to cloth material allowing light to pass criteria require that face coverings
select the testing scenario that is most through, otherwise meet this definition conform to the ASTM Standard and
appropriate for their workplace. Some and which may be used to facilitate meet additional quantitative leakage
employees and employers may rely on communication with people who are criteria. Although not required by the
testing that is conducted by a healthcare deaf or hard-of-hearing or others who standard, OSHA notes that face
provider (e.g., doctor or nurse) who need to see a speaker’s mouth or facial coverings that meet ASTM F3502–21
arranges for the specimen to be analyzed expressions to understand speech or requirements and the new NIOSH
at a laboratory or at a point-of-care sign language respectively. Face criteria may offer a higher level of
testing location (e.g., a pharmacy). The coverings can be manufactured or source control and wearer protection
involvement of licensed or accredited homemade, and they can incorporate a than those face coverings that do not
healthcare providers allows employers variety of designs, structures, and meet a consensus standard.
to have a high degree of confidence in materials. Face coverings provide A ‘‘facemask’’ means a surgical,
the suitability of the test and the test variable levels of protection based on medical procedure, dental, or isolation
results. Some large employers who set their design and construction. mask that is FDA-cleared, authorized by
up their own on-site testing program As explained in paragraph (i), face an FDA EUA, or offered or distributed
may partner with a healthcare covering use is required based on an as described in an FDA enforcement
organization (e.g., a local hospital or employee’s vaccination status. The policy. Facemasks may also be referred
clinic) or rely on a licensed healthcare criteria in the definition help to ensure to as ‘‘medical procedure masks.’’ This
provider to help obtain a CLIA that face coverings that are worn by definition provides clarification about
certificate of waiver. Other employers workers who are not fully vaccinated the exception to the face covering
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61519
requirement under paragraph (i)(1)(iii) October 15, 2021). OSHA has included includes only employees that are
that permits facemask use in lieu of face this because people who have received covered by this ETS and does not
coverings. OSHA notes that facemasks a heterologous primary vaccination include employees who are excluded
are not respirators, which are also series (including mixing of mRNA, from coverage under paragraph (b)(3).
defined in this section. adenoviral, and mRNA plus adenoviral Paragraph (d)(1) of the standard
Facemasks provide protection against products) are considered by the CDC to requires an employer to establish,
exposure to splashes, sprays, and spatter also meet this definition. OSHA implement, and enforce a written
of body fluids. Facemasks offer both considers a vaccination series that meets mandatory vaccination policy that
source control, as defined in this section the definition in subparagraph (ii) to be meets this definition. The benefits of
under face coverings, and protection for a primary vaccination for purposes of vaccination, including the effectiveness
the wearer. OSHA has previously the requirements to support vaccination of vaccination mandates, are discussed
established that facemasks are essential in paragraph (f). in Grave Danger (Section III.A. of this
PPE for employees in healthcare, under The employer obligations under the preamble) and Need for the ETS
both the general PPE standard (29 CFR ETS differ based on whether each (Section III.B. of this preamble).
part 1910.132) and the Bloodborne employee is fully vaccinated. This OSHA recognizes that vaccination
Pathogens standard (29 CFR part definition is relevant to the definition of policies may vary, as indicated in
1910.1030). Although not required, the mandatory vaccination policy, in this paragraph (d)(2). Any policy that
Summary and Explanation for paragraph (c), as well as the provisions permits the employee to choose between
paragraph (i) (Section VI.I. of this under paragraph (d) regarding written vaccination and COVID–19 testing and
preamble) addresses their inclusion in vaccination policy requirements and face covering use would not be
this standard. Additional information relevant procedures for workers who are considered a mandatory vaccination
on such facemasks can be found in fully vaccinated. Paragraph (e)(2) also policy under paragraph (d)(1), although
relevant FDA guidance. addresses fully vaccinated employees, such policy is permissible under
‘‘Fully vaccinated’’ means (i) a including the determination of paragraph (d)(2). In some cases,
person’s status 2 weeks after completing vaccination status and acceptable forms employers may implement vaccination
primary vaccination with a COVID–19 of proof. Lastly, the definition provides policies that differ by location or type of
vaccine with, if applicable, at least the clarity with regard to the requirements business operation and thus the
minimum recommended interval of paragraphs (g) and (i) respectively, application of paragraph (d)(2) might
between doses in accordance with the which contain requirements for regular vary across an employer’s workforce.
approval, authorization, or listing that COVID–19 testing and face covering use This is discussed in greater detail in the
is: (A) Approved or authorized for among employees who are not fully Summary and Explanation for
emergency use by the FDA; (B) listed for vaccinated. paragraph (d) (Section VI.D. of this
emergency use by the World Health Paragraph (e) requires employers to preamble).
Organization (WHO); or (C) determine each employee’s vaccination A ‘‘respirator’’ is a type of PPE that is
administered as part of a clinical trial at status, including whether they are fully certified by NIOSH under 42 CFR part
U.S. site, if the recipient is documented or partially vaccinated. By ‘‘partially 84 or is authorized under an EUA by the
to have of primary vaccination with the vaccinated,’’ OSHA means someone FDA. These specifications are intended
‘‘active’’ (not placebo) COVID–19 who has started a primary vaccination to ensure some consistent level of
vaccine candidate, for which vaccine series but not completed it (e.g., has testing, approval, and protection and to
efficacy has been independently received one dose of a two-dose series) prevent the use of counterfeit respirators
confirmed (e.g., by a data and safety or has completed their primary that will not offer adequate protection,
monitoring board) or if the clinical trial vaccination and two weeks have not which is important because respirators
participant from the U.S. sites had elapsed since the last dose of the are intended to protect the wearer when
received a COVID–19 vaccine that is primary vaccination. directly exposed to hazards. Respirators
neither approved nor authorized for use A ‘‘mandatory vaccination policy’’ is protect against airborne hazards by
by the FDA but is listed for emergency an employer policy requiring each removing specific air contaminants from
use by the WHO. Currently-authorized employee to be fully vaccinated. To the ambient (surrounding) air or by
FDA vaccines include Janssen (Johnson meet the definition of a mandatory supplying breathable air from a safe
& Johnson), which is a single-dose vaccination policy, the policy must source. Common types of respirators
primary vaccination, and Pfizer- require: Vaccination of all employees, include filtering facepiece respirators
BioNTech and Moderna, which have a including vaccination of all new (e.g., N95), elastomeric respirators, and
two-dose primary vaccination series. employees as soon as practicable, other powered air-purifying respirators
This definition is consistent with the than those employees (1) for whom a (PAPRs). Face coverings, facemasks, and
CDC definition of fully vaccinated (CDC, vaccine is medically contraindicated, (2) face shields are not respirators.
September 16, 2021). for whom medical necessity requires a As stated above, there are various
The definition of ‘‘fully vaccinated’’ delay in vaccination,91 or (3) who are types of respirators that would fall
also means a person’s status 2 weeks legally entitled to a reasonable within this definition. A filtering
after receiving the second dose of any accommodation under federal civil facepiece respirator (FFR) is a negative-
combination of two doses of a COVID– rights laws because they have a pressure particulate respirator with a
19 vaccine that is approved or disability or sincerely held religious non-replaceable filter as an integral part
authorized by the FDA, or listed as a beliefs, practices, or observances that of the facepiece or with the entire
two-dose series by the WHO (i.e., conflict with the vaccination facepiece composed of the non-
heterologous primary series of such requirement. OSHA intends that replaceable filtering medium. N95 FFRs
vaccines, receiving doses of different ‘‘employee,’’ as used in this definition, are the most common type of FFR and
COVID–19 vaccines as part of one are the type of respirator most often
primary series). The second dose of the 91 As defined by CDC’s informational document,
used to control exposures to infections
series must not be received earlier than Summary Document for Interim Clinical transmitted via the airborne route.
Considerations for Use of COVID–19 Vaccines
17 days (21 days with a 4-day grace Currently Authorized in the United States (CDC, When properly worn, N95 FFRs filter at
period) after the first dose (CDC, September 29, 2021). least 95% of airborne particles. An
App. 119
61520 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
elastomeric respirator is a tight-fitting employees who have mobile workplaces authorizations-medical-devices/in-vitro-
respirator with a facepiece that is made include maintenance and repair diagnostics-euas-molecular-diagnostic-
of synthetic or rubber material that technicians who go to homes or tests-sars-cov-2. (FDA, October 14,
2021b)
permits it to be disinfected, cleaned, businesses to provide repair services, or
Schulte P et al. (2021, May 19). Proposed
and reused according to the those who provide delivery services. Framework for Considering SARS–CoV–
manufacturer’s instructions. Elastomeric 2 Antigen Testing of Unexposed
respirators are equipped with References
Asymptomatic Workers in Selected
replaceable cartridges, canisters, or Centers for Disease Control and Prevention Workplaces. J Occup Environ Med. 2021
filters. Lastly, a powered air-purifying (CDC). (2021, June 14). Nucleic Acid Aug; 63(8): 646–656. Published online
respirator (PAPR) is an air-purifying Amplification Tests. https:// 2021, May 19. https://
respirator that uses a blower to force the www.cdc.gov/coronavirus/2019-ncov/ www.ncbi.nlm.nih.gov/pmc/articles/
ambient air through air-purifying lab/naats.html. (CDC, June 14, 2021). PMC8327768/. (Schulte et al., May 19,
Centers for Disease Control and Prevention 2021)
elements to the inlet covering. (CDC). (2021, September 16). When
This standard does not require the use You’ve Been Fully Vaccinated: How to D. Employer Policy on Vaccination
of respirators. This definition is Protect Yourself and Others. https:// Vaccination is a vital tool to reduce
included because it relates to paragraph www.cdc.gov/coronavirus/2019-ncov/ the presence and severity of COVID–19
(i)(1)(iii), which exempts employees vaccines/fully-vaccinated.html. (CDC, cases in the workplace, in communities,
from wearing face coverings when they September 16, 2021)
and in the nation as a whole. Despite
are wearing respirators or facemasks. In Centers for Disease Control and Prevention
(CDC). (2021, September 29). Summary the robust protection against COVID–19
addition, paragraph (i)(4) requires
Document for Interim Clinical that vaccination affords, millions of
employers to permit employees to wear
a respirator instead of a face covering Considerations for Use of COVID–19 eligible individuals have not yet been
and permits employers to provide Vaccines Currently Authorized in the vaccinated. Current efforts to increase
respirators to their employees, instead
United States. https://www.cdc.gov/ the proportion of the U.S. population
vaccines/covid-19/downloads/summary- that is fully vaccinated against COVID–
of face coverings. When respirators are interim-clinical-considerations.pdf.
used pursuant to paragraph (i)(4), the 19 are critical to ending the COVID–19
(CDC, September 29, 2021) pandemic (CDC, September 15, 2021).
employer must also comply with Centers for Disease Control and Prevention
§ 1910.504, the Mini Respiratory (CDC). (2021, October 7). Interim
As described more fully in Need for the
Protection Program. Guidance for SARS–CoV–2 Testing in ETS (Section III.B. of this preamble),
NIOSH has developed a set of Non-Healthcare Workplaces. https:// mandatory vaccination policies work.
regulations in 42 CFR part 84 for testing www.cdc.gov/coronavirus/2019-ncov/ Therefore, OSHA has determined that
and certifying non-powered, air- community/organizations/testing-non- requiring or strongly encouraging
purifying, particulate-filter respirators. healthcare-workplaces.html. (CDC, vaccination—the most effective and
October 7, 2021) efficient control for reducing COVID–
To help address concerns about
Centers for Disease Control and Prevention 19—is key to ensuring the protection of
availability during the COVID–19 (CDC). (2021, October 15). Interim Public
pandemic, the FDA has issued EUAs for workers against the grave danger of
Health Recommendations for Fully
certain PPE products, including Vaccinated People. https://www.cdc.gov/
exposure to SARS–CoV–2 in the
respiratory protective devices such as coronavirus/2019-ncov/vaccines/fully- workplace (see Grave Danger, Section
respirators. For the purposes of this vaccinated-guidance.html. (CDC, III.A. of this preamble). Therefore, this
standard, respirators certified by October 15, 2021) ETS requires employers to adopt
NIOSH, under 42 CFR part 84 or Equal Employment Opportunity Commission mandatory vaccination policies for their
authorized under an EUA by the FDA (EEOC). (2021, October 25). What You workplaces, with an exception for
meet the definition. Additional Should Know About COVID–19 and the employers that instead adopt a policy
ADA, the Rehabilitation Act, and Other allowing employees to elect to undergo
information on such respirators can be
EEO Laws. https://www.eeoc.gov/wysk/ regular COVID–19 testing and wear a
found in relevant FDA and NIOSH what-you-should-know-about-covid-19-
guidance. and-ada-rehabilitation-act-and-other-
face covering at work in lieu of
A ‘‘workplace’’ is a physical location eeo-laws. (EEOC, October 25, 2021) vaccination. In Need for the ETS
(e.g., fixed, mobile) where the Food and Drug Administration (FDA). (2020, (Section III.B of this preamble), OSHA
employer’s work or operations are November 16). COVID–19 Test Settings: explains its rationale for providing the
performed. It does not include an FAQs on Testing for SARS–CoV–2. exception.
employee’s residence, even if the https://www.fda.gov/medical-devices/ Paragraph (d) of this ETS is a critical
employee is teleworking from their coronavirus-covid-19-and-medical- element in ensuring employees’
residence. Examples of fixed locations devices/covid-19-test-settings-faqs- protection, as it requires covered
include: Offices, retail establishments, testing-sars-cov-2. (FDA, November 16, employers to develop, implement, and
2020) enforce written policies on COVID–19
co-working facilities, and factories or
Food and Drug Administration (FDA).
manufacturing facilities. A workplace (2021a, October 14). In Vitro Diagnostics
vaccination for their workforces.
includes the entire site (including EUAs—Antigen Diagnostic Tests for Paragraph (d)(1) requires the employer
outdoor and indoor areas, a structure or SARS–CoV–2. https://www.fda.gov/ to establish, implement, and enforce a
a group of structures) or an area within medical-devices/coronavirus-disease- written mandatory vaccination policy.
a site where work or any work-related 2019-covid-19-emergency-use- As defined in paragraph (c), a
activity occurs (e.g., taking breaks, going authorizations-medical-devices/in-vitro- mandatory vaccination policy is an
to the restroom, eating, entering or diagnostics-euas-antigen-diagnostic- employer policy requiring each
exiting work). The workplace includes tests-sars-cov-2. (FDA, October 14, employee to be fully vaccinated. Such a
the entirety of any space associated with 2021a) policy must require vaccination of all
Food and Drug Administration (FDA).
the site (e.g., workstations, hallways, (2021b, October 14)). In Vitro Diagnostics
employees, other than those employees
stairwells, breakrooms, bathrooms, EUAs—Molecular Diagnostic Tests for who fall into one of three categories: (1)
elevators) and any other space that an SARS–CoV–2. https://www.fda.gov/ Those for whom a vaccine is medically
employee might occupy in arriving, medical-devices/coronavirus-disease- contraindicated, (2) those for whom
working, or leaving. Examples of 2019-covid-19-emergency-use- medical necessity requires a delay in
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61521
vaccination, or (3) those who are legally employer must then ensure that it is policy under paragraph (d)(1); for
entitled to a reasonable accommodation following the policy, as laid out in its example, an employer with a mandatory
under federal civil rights laws because written plan. Finally, employers must vaccination policy might have
they have a disability or sincerely held ensure that they enforce the employees who cannot be vaccinated for
religious beliefs, practices, or requirements of their policies with medical reasons. Given the additional
observances that conflict with the respect to their workforce, through safety protocols under this standard for
vaccination requirement. The policy training and the use of such individuals who are not fully vaccinated
must also require all new employees to mechanisms as work rules and the (see paragraphs (g) and (i)), an employer
be vaccinated as soon as practicable. workplace disciplinary system, if who has both vaccinated and
Paragraph (d)(2) is a limited necessary. These requirements apply to unvaccinated employees will have to
exemption from the mandatory the written policy required under develop and include the relevant
vaccination policy requirement. As paragraph (d), whether employers procedures for two sets of employees in
discussed in Need for the ETS (Section choose to implement the mandatory the written policy. The procedures for
III.B. of this preamble), vaccination vaccination policy under paragraph those who are fully vaccinated should
mandates are effective at increasing (d)(1) or utilize the exemption under contain all the information previously
overall vaccination rates and protecting paragraph (d)(2) for all or a portion of discussed relevant to establishing,
employees and, therefore, the agency their workforce. implementing, and enforcing a
encourages all employers to implement To ensure that employers’ vaccination comprehensive written policy.
a mandatory vaccination policy. Under policies under paragraph (d) are However, the procedures applicable to
paragraph (d)(2), however, employers comprehensive and effective, the employees who are not fully vaccinated
can avoid the mandate in paragraph policies should address all of the (i.e., those who decline vaccination,
(d)(1) if the employer establishes, applicable requirements in paragraphs those who are unable to receive
implements, and enforces a written (e)–(j) of this standard, including: vaccination and are, absent undue
policy allowing any employee not Requirements for COVID–19 hardship to their employers, entitled to
subject to a mandatory vaccination vaccination; applicable exclusions from reasonable accommodation) and those
policy to choose either to: (1) Be fully the written policy (e.g., medical who are unable to provide proof of
vaccinated against COVID–19 or (2) contraindications, medical necessity vaccination as required by paragraph (e)
provide proof of regular testing for requiring delay in vaccination, or (who must be treated as not fully
COVID–19 in accordance with reasonable accommodations for workers vaccinated), must include COVID–19
paragraph (g) of this section and wear a with disabilities or sincerely held testing and face covering use as required
face covering in accordance with religious beliefs); information on by paragraphs (g) and (i), respectively,
paragraph (i). An employer who chooses determining an employee’s vaccination unless the reasonable accommodation
to operate under paragraph (d)(2), status and how this information will be from vaccination removes the employee
however, must still offer the support for collected (as described in paragraph (e)); from the scope of § 1910.501 (e.g., full
vaccination required under paragraph (f) paid time and sick leave for vaccination time telework consistent with one of the
and may not prevent employees from purposes (as described in paragraph (f)); exceptions in § 1910.501(b)(3)). OSHA
getting vaccinated. Adopting a policy notification of positive COVID–19 tests intends that such an employer will
under paragraph (d)(2) simply means and removal of COVID–19 positive develop one written plan that includes
that employees themselves may choose employees from the workplace (as different policies and procedures for
not to get vaccinated, in which case they described in paragraph (h)); information
vaccinated and unvaccinated
must get tested and wear face coverings to be provided to employees (pursuant
employees. The requirements of
per the requirements of the standard. to paragraph (j)—e.g., how the employer
OSHA recognizes there may be paragraphs (e), (f), (h), and (j) should be
is making that information available to
employers who develop and implement addressed in the policy regardless of the
employees); and disciplinary action for
partial mandatory vaccination policies, vaccination requirements adopted by
employees who do not abide by the
i.e., that apply to only a portion of their the employer.
policy. In addition to addressing the
workforce. An example might be a retail requirements of paragraphs (e)–(j) of this As with all elements of the written
corporation employer who has a standard, the employer should include plan, an effective written plan will
mixture of staff working at the corporate all relevant information regarding the explain the testing requirements
headquarters, performing intermittent policy’s effective date, who the policy contained in paragraph (g) for
telework from home, and working in applies to, deadlines (e.g., for unvaccinated employees, and how the
stores serving customers. In this type of submitting vaccination information, for employer will implement and enforce
situation, the employer may choose to getting vaccinated), and procedures for those policies. As described in
require vaccination of only some subset compliance and enforcement, all of paragraph (g)(1), the testing
of its employees (e.g., those working in which are necessary components of an requirements differ for employees who
stores), and to treat vaccination as effective plan. Having a comprehensive report at least once every 7 days to a
optional for others (e.g., those who work written policy will provide a solid workplace compared to those who do
from headquarters or who perform foundation for an effective COVID–19 not. Thus, the policy may describe
intermittent telework). This approach vaccination program, while making it different testing procedures for those
would comply with the standard so long easier for employers to inform different groups of employees,
as the employer complies in full with employees about the program-related depending on how often they physically
paragraph (d)(1) and (d)(2) for the policies and procedures, as required report to a workplace where other
respective groups. under paragraph (j)(1). individuals are present. As described in
OSHA uses the terms establish, If an employer utilizes the exemption paragraph (g)(3), the testing
implement, and enforce in paragraph (d) under paragraph (d)(2), its workplace requirements are temporarily suspended
to emphasize that it is necessary for an may contain employees who are for 90 days following a positive COVID–
employer to first determine its policy vaccinated and unvaccinated. This 19 test or diagnosis. Thus, the
and create a written record of that might be the case even for employers employer’s policy and procedures to
policy. After determining the policy, an who establish a mandatory vaccination implement this temporary suspension of
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61522 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
testing should be included in their hardship. If the worker requesting a vaccines/covid-19/downloads/summary-
written workplace policy. In addition to reasonable accommodation cannot be interim-clinical-considerations.pdf.
the testing requirements in paragraph vaccinated and/or wear a face covering (CDC, September 29, 2021)
Equal Employment Opportunity Commission
(g), an effective policy must address because of a disability, as defined by the (EEOC). (2021, October 25). What You
mandatory face covering use as Americans with Disabilities Act (ADA), Should Know About COVID–19 and the
described in paragraph (i), including that worker may be entitled to a ADA, the Rehabilitation Act, and Other
procedures for employee compliance. reasonable accommodation. In addition, EEO Laws. https://www.eeoc.gov/wysk/
Employers can get more information on if the vaccination, and/or testing for what-you-should-know-about-covid-19-
the requirements for paragraphs (e) COVID–19, and/or wearing a face and-ada-rehabilitation-act-and-other-
through (j), and what they must do to covering conflicts with a sincerely held eeo-laws. (EEOC, October 25, 2021)
comply with those provisions of the religious belief, practice or observance, E. Determination of Employee
standard, in the relevant Summary and a worker may be entitled to a reasonable Vaccination Status
Explanation sections (see Section VI. of accommodation. Such accommodations
this preamble). To comply with the requirements of
exist independently of the Occupational
As an employer develops their written the standard, it is essential that
Safety and Health Act and, therefore,
policy, they must address how the employers are aware of each employee’s
OSHA does not administer or enforce
policy will apply to new employees. vaccination status. As discussed in the
these laws. Examples of relevant federal
Although many new hires will be fully Summary and Explanation for
laws under which an accommodation
vaccinated, there should be procedures paragraph (d) (Section VI.D. of this
can be requested include the Americans
within the plan to collect information preamble), effective implementation and
with Disabilities Act (ADA) and Title enforcement of a written vaccination
about the new employee’s vaccination VII of the Civil Rights Act of 1964.
status, and determine when an policy requires the employer to know
For more information, the note refers
unvaccinated new hire must be the vaccination status of all employees.
to a resource produced by the Equal
vaccinated and, for employers using a Furthermore, the employer must know
Employment Opportunity Commission
plan under paragraph (d)(2), when each employee’s vaccination status in
(EEOC), which is responsible for
COVID–19 testing and face covering use order to ensure that the vaccination,
enforcing federal laws that prohibit
will commence if an employee remains testing, and face covering requirements
employment-related discrimination
unvaccinated. All new hires should be of the standard are met. As such,
based on a person’s race, color, religion,
treated similarly to any employee who paragraph (e) includes provisions for
sex (including pregnancy, gender
has not entered the workplace in the last determining each employee’s
identity, and sexual orientation),
seven days and will need to be fully vaccination status. The standard
national origin, age (40 or older),
vaccinated or provide proof of a requires employers to determine the
disability, or genetic information. The
negative COVID–19 test within the last vaccination status of each employee
EEOC resource listed in the note, What
seven days prior to entering the (paragraph (e)(1)), and also to maintain
You Should Know About COVID–19
workplace for the first time. It is not records of each employee’s vaccination
and the ADA, the Rehabilitation Act,
OSHA’s intention to discourage status, preserve acceptable proof of
and Other EEO Laws, available at
employers from hiring new employees, vaccination for each employee who is
https://www.eeoc.gov/wysk/what-you-
but rather to ensure that new employees fully or partially vaccinated, and
should-know-about-covid-19-and-ada-
are as well-protected from COVID–19 maintain a roster of each employee’s
rehabilitation-act-and-other-eeo-laws,
hazards in the workplace as current vaccination status (paragraph (e)(4)). As
should be helpful to employers in
employees and are less likely to spread discussed more fully below,
navigating employees’ requests for
the virus to other employees. maintenance of records in accordance
accommodations, including the process
An employer may have already with this paragraph is subject to
for determining a reasonable
developed and implemented a written applicable legal requirements for
accommodation and information on
policy on vaccination, testing, and/or confidentiality of medical information.
undue hardship (EEOC, October 25,
face covering use to protect employees Additional provisions in paragraph (e)
2021). An additional resource that might
from COVID–19. It is not OSHA’s intent define acceptable proof of vaccination
be helpful is the CDC’s informational
for employers to duplicate current status for vaccinated employees
document, Summary Document for
effective policies covering the (paragraph (e)(2)) and provide that any
Interim Clinical Considerations for Use
requirements of this ETS; however, each employee who does not submit an
of COVID–19 Vaccines Currently
employer with a current policy must acceptable form of proof of vaccination
Authorized in the United States (CDC,
evaluate that policy to ensure it satisfies status must be treated as not fully
all of the requirements of this rule. September 29, 2021), which lists the
vaccinated (paragraph (e)(3)).
Employers with existing policies must recognized clinical contraindications to Paragraph (e)(1) requires the employer
modify and/or update their current receiving a COVID–19 vaccine. to determine the vaccination status of
policies to incorporate any missing References each employee, including whether the
required elements, and must provide employee is fully vaccinated. Under
Centers for Disease Control and Prevention
information on these new updates or (CDC). (2021, September 15). Science paragraph (e)(2), the employer must
modifications to all employees in Brief: Background rationale and evidence require each vaccinated employee to
accordance with paragraph (j)(1). Once for public health recommendations for provide acceptable proof of vaccination
the employer has developed its policy fully vaccinated people. https:// status, including whether they are fully
pursuant to paragraph (d), the policy www.cdc.gov/coronavirus/2019-ncov/ or partially vaccinated. This is an
must be reduced to writing in order to science/science-briefs/fully-vaccinated- ongoing requirement for the employer
be compliant with paragraph (d). people.html. (CDC, September 15, 2021) (i.e., the employer needs to update this
The note to paragraph (d) was Centers for Disease Control and Prevention
(CDC). (2021, September 29). Summary
information as employees proceed
included in recognition that, under Document for Interim Clinical through the vaccination process).
federal law, some employees may be Considerations for Use of COVID–19 Paragraph (e)(2) defines what
entitled to a reasonable accommodation Vaccines Currently Authorized in the ‘‘acceptable proof of vaccination status’’
from their employer, absent undue United States. https://www.cdc.gov/ means for purposes of the ETS, and
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61523
employers must accept any of the proofs code itself, to comply with paragraph be acceptable for proof of vaccination
listed in accordance with the terms of (e)(4). In requesting proof of under paragraph (e)(2)(vi), the employee
the standard and as explained more vaccination, the employer must take must have attempted to secure alternate
fully below. Under paragraph (e)(2), the care to comply with any applicable forms of documentation via other means
following are acceptable for proof of Federal laws, including requirements (e.g., from the vaccine administrator or
vaccination: (i) The record of under the Privacy Act, 5 U.S.C. 552a, their state health department) and been
immunization from a health care and the Americans with Disabilities Act unsuccessful in doing so. The agency
provider or pharmacy; (ii) a copy of the (ADA), 42 U.S.C. 12101 et seq. recognizes that securing vaccination
U.S. CDC COVID–19 Vaccination Each employee who has been partially documentation may be challenging for
Record Card (CDC Form MLS–319813_ or fully vaccinated should be able to some members of the workforce, such as
r, published on September 3, 2020) provide one of the forms of acceptable migrant workers, employees who do not
(CDC, October 5, 2021); (iii) a copy of proof listed above (paragraphs (e)(2)(i)– have access to a computer, or employees
medical records documenting the (e)(2)(v)). An employee who does not who may not recall who administered
vaccination; (iv) a copy of immunization possess their COVID–19 vaccination their vaccines (e.g., if the vaccination
records from a public health, state, or record (e.g., because it was lost or was provided at a temporary location,
tribal immunization information system; stolen) should contact their vaccination such as a church, or during a state or
or (v) a copy of any other official provider (e.g., local pharmacy, local mass vaccination campaign). Thus,
documentation that contains the type of physician’s office) to obtain a new copy for employees who have no other means
vaccine administered, date(s) of or utilize their state health department’s of obtaining proof of vaccination, the
administration, and the name of the immunization information system. In standard permits employers to accept
health care professional(s) or clinic instances where an employee is unable attestations meeting the requirements in
site(s) administering the vaccine(s). to produce acceptable proof of paragraph (e)(2)(vi) as proof of
vaccination under paragraphs (e)(2)(i)– vaccination. However, employers
To be acceptable as proof of
(e)(2)(v), paragraph (e)(2)(vi) provides should explain to their employees that
vaccination, any documentation should
that a signed and dated statement by the they need to produce vaccination proof
generally include the employee’s name,
employee will be acceptable. The through the other means listed in
type of vaccine administered, date(s) of
employee’s statement must: (A) Attest to paragraph (e)(2), such as by contacting
administration, and the name of the
their vaccination status (fully the vaccination administrator, if they
health care professional(s) or clinic vaccinated or partially vaccinated); (B) are able to do so. Once the employee has
site(s) administering the vaccine(s). In attest that they have lost or are provided a signed and dated attestation
some cases, state immunization records otherwise unable to produce proof that meets the requirements of
may not include one or more of these required by the standard; and (C) paragraph (e)(2)(vi), the employer no
data fields, such as clinic site; in those include the following language: ‘‘I longer needs to seek out one of the other
circumstances, an employer can still declare (or certify, verify, or state) that forms of vaccination proof for that
rely upon the State immunization this statement about my vaccination employee and, depending on the
record as acceptable proof of status is true and accurate. I understand content of the attestation, the employer
vaccination. OSHA notes that clinic that knowingly providing false may consider that employee either fully
sites can include temporary vaccination information regarding my vaccination or partially vaccinated for purposes of
facilities used during large vaccine status on this form may subject me to the ETS.
distribution campaigns, such as schools, criminal penalties.’’ The note to Recently, there has been evidence of
churches, or sports stadiums. Copies, paragraph (e)(2)(vi) explains that an fraud associated with people attesting to
including digital copies, of the listed employee who attests to their their vaccination status (Bergal,
forms of proof are acceptable means of vaccination status should, to the best of September 16, 2021). While employers
documentation so long as they clearly their recollection, include the following may not invite or facilitate fraud, the
and legibly display the necessary information in their attestation: The ETS does not require employers to
information. Digital copies can include, type of vaccine administered; date(s) of monitor for or detect fraud. By defining
for example, a digital photograph, administration; and the name of the what constitutes acceptable proof of
scanned image, or PDF of an acceptable health care professional(s) or clinic vaccination under the ETS, OSHA is
form of proof. Some state governments site(s) administering the vaccine(s). For ensuring that employers can accept
are utilizing digital COVID–19 vaccine example, some of the information may proof meeting the requirements of
records showing the same information be easier to recall, such as receiving a paragraph (e) for purposes of
as the U.S. CDC COVID–19 Vaccination vaccine at a mass vaccination site or compliance with the standard. However,
Record Card (CDC Form MLS–319813_ local pharmacy, while the dates of the standard’s requirements for proof of
r, published on September 3, 2020) and administration might only be vaccination are integral to ensuring that
providing quick response (QR) codes remembered as falling within a employees are protected appropriately,
that when scanned will provide the particular month or months. OSHA either through vaccination (the
same information (see, e.g., New York understands that employees may not be preferred and most effective workplace
State Government, n.d., Retrieved able to recall certain information, such control in this ETS), or through regular
October 4, 2021). In certain states, the as the type of vaccine received. testing and use of face coverings. Thus,
QR code confirms the vaccine record as Employees providing attestations it is paramount that employees provide
an official record of the state (see, e.g., should include as much of this truthful information regarding their
State of California, n.d., Retrieved information as they can remember to the vaccination status.
October 7, 2021) and therefore would best of their ability. As discussed in more detail in the
provide acceptable proof of vaccination Any statement provided under Summary and Explanation for
under the ETS (see paragraph (e)(2)(iv)). paragraph (e)(2)(vi) must include an paragraph (j) (Section VI.J. of this
However, as discussed later, the attestation that the employee is unable section), 18 U.S.C. 1001(a), which
employer must retain a copy of the to produce another type of proof of provides for fines or imprisonment of
vaccination information retrieved when vaccination (paragraph (e)(2)(vi)(B)). generally up to 5 years for any person
the QR code is scanned, not just the QR Thus, before an employee statement will who ‘‘in any matter within the
App. 123
61524 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
jurisdiction’’ of the executive branch that include COVID–19 testing in their vaccinated, not fully vaccinated because
U.S. Government ‘‘knowingly and written policies under paragraph (d), of a medical or religious
willfully’’ engages in any of the employees without acceptable proof of accommodation (see Note to paragraph
following: vaccination status must submit to (d)), or not fully vaccinated because
(1) Falsifies, conceals, or covers up by weekly tests (as required by paragraph they have not provided acceptable proof
any trick, scheme, or device a material (g)) and wear a face covering (as of their vaccination status. As noted
fact; required by paragraph (i)). previously, any employee that has not
(2) makes any materially false, Paragraph (e)(4) requires the employer provided acceptable proof of their
fictitious, or fraudulent statement or to maintain a record of each employee’s vaccination status must be treated as not
representation; or vaccination status and preserve fully vaccinated. Although
(3) makes or uses any false writing or acceptable proof of vaccination for each unvaccinated employees will not have
document knowing the same to contain employee who is fully or partially proof of vaccination status, the standard
any materially false, fictitious, or vaccinated. As discussed previously, the requires the employer to include all
fraudulent statement or entry. employer has various options for employees, regardless of vaccination
Similarly, the OSH Act recognizes acquiring proof of vaccination from each status, on the roster.
that OSHA’s ability to protect workers’ employee. An employer may allow The roster allows the employer to
safety and health hinges on truthful employees to provide a digital copy of easily access the vaccination status for
reporting. For that reason section 17(g) acceptable records, including, for any employee quickly and easily. This
of the OSH Act subjects anyone who example, a digital photograph, scanned will be useful should the employer need
‘‘knowingly makes any false statement, image, or PDF of such a record that to respond to a request from an
representation, or certification in any clearly and legibly displays the employee or employee representative
application, record, report, plan, or necessary vaccination information. for the aggregate number of fully
other document filed or required to be However, to be in compliance with vaccinated employees at a workplace
maintained pursuant to this chapter’’ to paragraph (e)(4), the employer must (along with the total number of
criminal penalties. 29 U.S.C. 666(g). ensure they are able to maintain a employees at that workplace), as
False statements made in any proof record of each employee’s vaccination required under paragraph (l)(2).
submitted under paragraph (e)(2) of the status. Therefore, obtaining an Additionally, the roster will help the
standard could fall under either or both employee’s vaccination information employer implement the written policy
of 18 U.S.C. 1001 or section 17(g) of the verbally would not comply with developed in accordance with
OSH Act. And by requiring a specific paragraph (e)(2) or satisfy the record paragraph (d) and comply with other
declaration about the truth and accuracy maintenance requirements of the requirements of the ETS. And finally,
of employee statements provided under standard. Similarly, the record the roster, which must be provided to
paragraph (e)(2)(vi), employees who are maintenance requirements of paragraph OSHA on request (paragraph (l)(3)), will
unable to provide any means of proof (e)(4) cannot be fulfilled by an employee aid OSHA’s ability to effectively and
other than their own attestation are merely showing the employer their efficiently enforce this ETS.
being made aware that their words are vaccination status (e.g., by bringing the The records and roster required by
being held to the same standard of CDC COVID–19 vaccination card to the paragraph (e)(4) are considered to be
truthfulness as any other record workplace and showing it to an employee medical records and must be
presented for proof of vaccination. employer representative or showing an maintained as such records in
OSHA notes that these same employer representative a picture of the accordance with 29 CFR 1910.1020 and
prohibitions on false statements and immunization records on a personal must not be disclosed except as required
documentation can apply to employers. cellphone). To satisfy paragraph (e)(4), or authorized by this ETS or other
If an employer knows that proof the employer must retain a copy of the federal law, including the Americans
submitted by an employee is fraudulent, documentation. As mentioned above, with Disabilities Act (ADA), 42 U.S.C.
and even with this knowledge, accepts some states and local governments 12101 et seq. These records and roster
and maintains the fraudulent proof as a utilize QR codes to facilitate proof of are not subject to the retention
record of compliance with this ETS, it vaccination. This can be an acceptable requirements of 29 CFR
may be subject to the penalties in 18 form of proof for compliance with the 1910.1020(d)(1)(i) but must be
U.S.C. 1001 and 17(g) of the OSH Act. standard so long as the employer retains maintained and preserved while this
Paragraph (e)(3) provides the a copy of the information retrieved by ETS remains in effect. OSHA considers
mechanism for employers to determine scanning the QR code and maintains vaccination records required by
vaccination status for employees who that record. Required records of paragraphs (e)(2) and (e)(4) of the ETS
do not submit any of the acceptable vaccination status can be maintained to be employee medical records
forms of proof of vaccination status. physically or electronically, but the concerning the health status of an
Under paragraph (e)(3), any employee employer must ensure they have access employee and is requiring this
who does not provide their employer to the records at all times. personally identifiable medical
with one of the acceptable forms of In addition to obtaining and information to be maintained in a
proof of vaccination status in paragraph maintaining individual records of each confidential manner. OSHA notes that
(e)(2) must be treated as not fully employee’s vaccination status and under paragraph (e)(4), vaccination
vaccinated for the purpose of the preserving acceptable proof of records and rosters are employee
standard. An unvaccinated employee vaccination for each employee who is medical records, and must be treated as
does not need to provide any partially or fully vaccinated, under employee medical records under 29 CFR
documentation regarding vaccination paragraph (e)(4) the employer must 1910.1020, without regard to whether
status under this ETS; however, failing maintain a roster of each employee’s the records satisfy the definition of
to provide acceptable proof of vaccination status, subject to applicable employee medical record at 29 CFR
vaccination status will signal the confidentiality requirements. The roster 1910.1020(c)(6)(i).
employer to consider the employee as must list all employees and clearly Paragraph (e) in 29 CFR 1910.1020
not fully vaccinated and to note that as indicate for each one whether they are includes requirements for access to
their status in the roster. For employers fully vaccinated, partially (not fully) employee medical records by
App. 124
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61525
employees, their designated considered to have retained records of State of California. (n.d.) Frequently Asked
representatives, and OSHA. However, as that ascertainment for the purposes of Questions. Retrieved October 7, 2021
discussed in more detail below, this ETS. However, if, for example, the from https://
paragraph (l) of the ETS includes employer had the employees provide myvaccinerecord.cdph.ca.gov/faq. (State
of California, n.d., Retrieved October 7,
specific timeframes within which their vaccine information on a dated 2021).
employers must make vaccine records form, or through individual emails
available to employees, OSHA, and retained by the employer, or on an F. Employer Support for Employee
other specified individuals. employer portal specifically created for Vaccination
Accordingly, the timeframes for employees to provide documentation As discussed in the Summary and
providing access to employee medical status, or the employer created and Explanation for paragraph (d) (Section
records in 29 CFR 1910.1020(e) do not retained some other means of VI.D. of this preamble), as well as in
apply, and employers must follow the documentation, the employer is Grave Danger and Need for the ETS
specific timeframes set forth in considered to have retained records of (Sections III.A. and III.B. of this
paragraph (l) of the ETS for providing ascertainment for the purposes of this preamble), vaccination is the single
access to vaccination records. ETS. Even if the record does not have most efficient and effective method for
Additionally, 29 CFR 1910.1020(d) all of the elements of the acceptable protecting unvaccinated workers from
addresses the preservation of employee forms of proof listed in paragraph (e)(2), the grave danger posed by COVID–19.
exposure and medical records. so long as the employer has ascertained This emergency temporary standard is
Paragraph (d)(1)(i) in section 1910.1020 employee vaccination status prior to the therefore designed to strongly encourage
generally provides that unless a specific effective date of the ETS through vaccination. As discussed in detail
occupational safety and health standard another form of attestation or proof, and
below, paragraph (f) requires employers
provides a different period of time, each retained records of that ascertainment,
to support vaccination by providing
employer must preserve and maintain the employer does not need to re-
employees reasonable time, including
employee medical records for at least determine vaccination status (paragraph
the duration of employment plus thirty up to four hours of paid time, to receive
(e)(1)) or obtain proof of vaccination
(30) years. Paragraph (e)(4) of the ETS each primary vaccination dose, and
status (paragraph (e)(2)) for fully
specifically provides that the reasonable time and paid sick leave to
vaccinated employees. For purposes of
vaccination records required by the ETS recover from side effects experienced
paragraph (e)(4), the employer’s records
are not subject to the retention following each primary vaccination
of vaccination status for each employee
requirements of 29 CFR dose. For purposes of the requirements
whose fully vaccinated status was
1910.1020(d)(1)(i). Instead, paragraph to support vaccination in paragraph (f),
previously documented constitute
(e)(4) states that vaccination records OSHA considers a vaccination series
acceptable proof of vaccination.
must be maintained and preserved only that meets the criteria in subparagraph
However, the employer must still
so long as the ETS remains in effect. (ii) of the definition of ‘‘fully-
develop a roster of each employee’s
Finally, while the provisions on vaccinated’’ (i.e., a heterologous primary
vaccination status and include on that
timeframes for access to records and the series of such vaccines, receiving doses
roster the employees for whom it had
retention provisions of 29 CFR of different COVID–19 vaccines as part
previously determined and retained
1910.1020 do not apply to vaccine of one primary series) to be a primary
records of vaccination status. OSHA
records required by the ETS, other vaccination series, along with the
notes that if the employer has not
provisions in that regulation can still primary vaccination described in
ascertained employee vaccination status
apply. For example, 29 CFR subparagraph (i) of that definition (see
for employees prior to the effective date
1910.1020(h) includes requirements for the Summary and Explanation for
of the ETS, then all requirements of
the transfer of employee medical paragraph (c), Section VI.C. of this
paragraph (e) would apply. And all
records when an employer ceases to do preamble, for more information on the
requirements of paragraph (e) also apply
business. definition of fully vaccinated).
with respect to employees for whom the
OSHA recognizes the possibility that Removing logistical barriers to
employer ascertained only partial
an employer may have already collected obtaining vaccination is essential to
vaccination status prior to the effective
information about the vaccination status increasing workforce vaccination rates,
date of the ETS.
of employees, including proof of and one such barrier for many
vaccination, prior to the effective date of References employees is their lack of time off of
this ETS. Under paragraph (e)(5), when Bergal J. (2021, September 16). Fake Vaccine
work to receive the vaccine and recover
an employer has ascertained employee Card Sales Have Skyrocketed Since from any potential side effects (SEIU
vaccination status prior to the effective Biden Mandate. https:// Healthcare, February 8, 2021).
date of the ETS through another form of www.pewtrusts.org/en/research-and- Employees’ concerns about missing
attestation or proof, and retained analysis/blogs/stateline/2021/09/16/ work to obtain and recover from a
records of that ascertainment, the fake-vaccine-card-sales-have- COVID–19 vaccination dose are well
employer is exempt from the skyrocketed-since-biden-mandate. documented. In a McKinsey survey,
(Bergal, September 16, 2021).
requirements in paragraphs (e)(1)–(e)(3). Centers for Disease Control and Prevention
12% of respondents stated that the time
The exemption applies only for each (CDC). (2021, October 5). Getting Your spent away from work to get vaccinated
employee whose fully vaccinated status CDC COVID–19 Vaccination Record or due to vaccine side effects was a
has been documented prior to the Card. https://www.cdc.gov/coronavirus/ barrier to vaccination (Azimi et al.,
effective date of the standard. For 2019-ncov/vaccines/vaccination- April 9, 2021). In a survey conducted of
example, an employer may have asked card.html. (CDC, October 5, 2021). unvaccinated adults in April 2021, a
each employee to self-report their New York State Government. (n.d.) Excelsior fifth of respondents said they were very
vaccination status without requiring the Pass and Excelsior Pass Plus. Retrieved or somewhat concerned that they may
October 4, 2021 from https://
employee to provide any form of proof. covid19vaccine.health.ny.gov/excelsior- need to take time off to go and get the
If that self-reporting was through oral pass-and-excelsior-pass-plus. (New York vaccine, and 48% of respondents said
conversation only, and not documented State Government, n.d., Retrieved that they were very or somewhat
in some way, the employer is not October 4, 2021). concerned that they might miss work if
App. 125
61526 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
the vaccine side effects make them feel workers’ lack of access to paid time off vaccination or for recovery from side
sick (KFF, May 6, 2021). Black and for vaccination comports with a effects, employee vaccination rates were
Hispanic adults were particularly different report indicating that, before higher than if no support was provided,
worried about the potential time the pandemic, about 65% of the lowest- and in May 2021, workers with paid
necessary to receive the vaccine and to wage workers had no access to paid sick sick leave were 15% more likely to have
recover from vaccine side effects; 64% leave, meaning that any time off for gotten the vaccine than workers without
of unvaccinated Hispanic adults and vaccination or recovery would result in such leave (Bellew et al., June 2021).
55% of unvaccinated Black adults lost wages for those who can least afford To address this barrier to vaccination,
expressed concern that they might have those losses (BLS, September 2021). The paragraph (f) requires employers to
to miss work due to the side effects of need for paid time off to receive support COVID–19 vaccination by
a COVID–19 vaccine, and 30% of vaccination is also particularly providing each employee with
Hispanic adults and 23% of Black important for workers with disabilities reasonable time, including up to four
adults were concerned that they might and workers in rural areas because hours of paid time, to receive each
need to take time off work to get a travel to and from vaccination sites may primary vaccination dose, and
COVID–19 vaccine (KFF, May 6, 2021; take more time or be more logistically reasonable time and paid sick leave to
KFF, May 17, 2021). News and journal difficult for those populations (National recover from side effects experienced
articles further evince this concern (Roy Safety Council, 2021). following any primary vaccination dose.
et al., December 29, 2020; Cleveland Paying workers for the time spent to Providing this time is essential for all
Documenters, 2021; Rosenberg and receive vaccination and to recover from unvaccinated employees who are
Stein, August 18, 2021). side effects has proven to be an effective covered by this rule to ensure that they
This concern reflects the fact that method for increasing vaccination rates. can receive primary vaccination dose(s)
many workers do not have access to In June 2021, KFF found that and recover from side effects without
paid time off to receive vaccination or approximately 75% of employed adults sacrificing pay or their jobs. In
to recover from side effects. A KFF surveyed who received paid time off to workplaces where employers implement
survey found that only half of all get the vaccine or to recover from side a mandatory vaccination policy in
workers reported that their employer effects had received at least one dose of accordance with paragraph (d)(1) of this
provided them with paid time off either the vaccine compared to only 51% of rule, the requirements of paragraph (f)
to get a COVID–19 vaccine or to recover those surveyed who did not receive paid ensure that employees are able to
from any side effects (KFF, June 30, time off from their employer (KFF, June comply with the mandatory vaccination
2021). A subsequent KFF survey found 30, 2021). KFF also found that policy without concern about missing
that only about one-third of workers employees who are provided paid time work to do so. In workplaces where the
were sure that their employer offered off and are encouraged by their employer opts out of implementing a
them paid time off to get a COVID–19 employers to get vaccinated are more mandatory vaccination policy in
vaccine and recover from side effects likely to get vaccinated, even after accordance with paragraph (d)(2), the
(KFF, September 28, 2021). Although controlling for demographic requirements of paragraph (f) encourage
employee access to paid sick leave is characteristics that may impact employees to choose vaccination, and
less of a concern for employers with 100 vaccination uptake (KFF, June 30, 2021). ensure that employees who choose to
or more employees, approximately 12% Another KFF survey found that 28% of obtain vaccination, rather than be
of employees in these situations do not unvaccinated respondents who did not regularly tested for COVID–19 and wear
have paid sick leave (BLS, September want to get the vaccine as soon as a face covering in most situations when
2021) and in some cases, employees possible said that they would be more they work near others, are not penalized
may have already exhausted paid sick likely to obtain vaccination if their for making that choice.
leave they have received and would employer gave them paid time off to get Paragraph (f)(1) requires employers to
need additional time from their vaccinated and recover from any side support COVID–19 vaccination for each
employers to recover from vaccine side effects (KFF, May 6, 2021). KFF has also employee by providing reasonable time
effects. found that increasing access to paid to each employee during work hours for
The scarcity of paid time off for leave for vaccination or recovery from each of their primary vaccination
vaccination and side effect recovery is side effects can also help further reduce dose(s), including up to four hours of
particularly acute for certain disparities in vaccination by age and paid time, at the employee’s regular rate
demographic groups. The June 2021 income (KFF, September 28, 2021). of pay, for the purposes of vaccination.
KFF survey found that only 38% of In a different survey, paid time off for Reasonable time may include, but is not
Black workers reported getting either vaccination and the recovery period limited to, time spent during work
paid time off to get a COVID–19 vaccine post-vaccination was the single most- hours related to the vaccination
or to recover from side effects, and that influential action for encouraging appointment(s), such as registering,
only 41% of workers with household employee vaccination, with 75% of completing required paperwork, all time
incomes less than $40,000 annually had respondents indicating that such paid spent at the vaccination site (e.g.,
access to such paid time off (KFF, June time off would significantly or receiving the vaccination dose, post-
30, 2021). Similarly, the September moderately increase the likelihood that vaccination monitoring by the vaccine
2021 KFF survey found that lower-wage they would get vaccinated (Azimi et al., provider), and time spent traveling to
workers were particularly unlikely to April 9, 2021). Another survey of nearly and from the location for vaccination
report access to paid time off for 9,000 service workers across large (including travel to an off-site location
vaccination or recovery, with only 23% grocery, retail, food service, pharmacy, (e.g., a pharmacy), or situations in
of workers whose household incomes and delivery firms, found that which an employee working remotely
was less than $40,000 reporting that vaccination rates were lower than other (e.g., telework) or in an alternate
they could take paid time off to get frontline workers who also regularly location must travel to the workplace to
vaccinated, and only 28% of that group work in-person and indoors, and when receive the vaccine).
reporting that they could take paid time employers supported and facilitated Employers are not, however, obligated
off to recover from side effects (KFF, vaccination, such as through providing by this ETS to reimburse employees for
September 28, 2021). Lower-wage paid time off or paid sick leave for transportation costs (e.g., gas money,
App. 126
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61527
train/bus fare, etc.) incurred to receive of the emergency paid leave created for Although some individuals
the vaccination. This could include the federal employees in the American experience no side effects from COVID–
costs of travel to an off-site vaccination Rescue Plan Act of 2021 (Public Law 19 vaccination doses, the CDC has
location (e.g., a pharmacy) or travel from 117–2), which encouraged agencies to identified a range of side effects that
an alternate work location (e.g., offer up to four hours of administrative other individuals may experience
telework) to the workplace to receive a leave per dose to cover time spent following a vaccination dose (CDC,
vaccination dose. getting a vaccine dose, plus additional April 2, 2021; CDC, September 30,
Because employers are required to time if reasonably necessary, instead of 2021). Side effects may affect
provide reasonable time for vaccination having employees use emergency paid individuals’ ability to engage in daily
during work hours, if an employee leave (OPM, April 29, 2021). OSHA activities, are typically mild-to-
chooses to receive a primary vaccination expects that most employees will need moderate in severity, and usually go
dose outside of work hours, employers less than four hours to receive a away in a few days. Common side
are not required to grant paid time to the vaccination dose. effects include pain, redness, and
employee for the time spent receiving The maximum of four hours of paid swelling at the site of injection, and
the vaccine during non-work hours. time that employers must provide under systemic side effects throughout the
However, even if employees receive a paragraph (f)(1)(ii) for the body, including tiredness, headache,
primary vaccination dose outside of administration of each primary muscle pain, chills, fever, and nausea.
work hours, employers must still afford vaccination dose cannot be offset by any Side effects may be sufficiently severe to
them reasonable time and paid sick other leave that the employee has require the employee to take sick leave
leave to recover from side effects that accrued, such as sick leave or vacation from work, but will rarely extend
they experience during scheduled work leave. OSHA is concerned that beyond a few days. One study found
time in accordance with paragraph employees forced to use their sick leave that ‘‘unanticipated paid administrative
(f)(2). or vacation leave for vaccination would leave was only required for 4.9% and
An employer may make other efforts have a disincentive to gaining the health 19.79% of individuals after the first and
to facilitate vaccination of its employees protection of vaccination. Employers second doses of vaccine, respectively’’
by, for example, hosting a vaccine clinic (Levi et al., September 25, 2021).
must pay employees for up to four hours
at the workplace (e.g., mobile trailer) or Employees would not typically be
of time at the employee’s regular rate of
partnering with another entity, such as expected to need leave solely to address
pay. This may be achieved by paying for
a pharmacy or healthcare provider, so redness or swelling at the site of
the time to be vaccinated as work hours
that employees can be vaccinated at the injection, but it is not uncommon for
for up to four hours. Requiring
workplace or at an off-site location. If an vaccine recipients to require some
employers to pay for vaccine
employer chooses to make the vaccine recovery time for many of the other side
administration is consistent with
available to its employees, it must effects. The CDC notes, however, that
OSHA’s normal approach of requiring
support full vaccination (i.e., provide all
employers to bear the costs of cough, shortness of breath, runny nose,
doses in a primary vaccination, as
compliance with safety and health sore throat, or loss of taste or smell are
applicable), and assure the availability
standards. not consistent with post-vaccination
of reasonable time and paid time to each
OSHA understands that employees symptoms and instead may be
employee to receive the full primary
may need much less than four hours to symptoms of COVID–19 or another
vaccination, and reasonable time and
receive a primary vaccination dose, for infection (CDC, April 2, 2021).
paid sick leave to recover from side
effects that they may experience. Any example, if vaccinations are offered on- If an employee already has accrued
additional costs incurred by the site. However, OSHA also understands paid sick leave, an employer may
employer to bring vaccination on-site that, in some circumstances, an require the employee to use that paid
would be covered by the employer, employee may need more than four sick leave when recovering from side
though such an approach would likely hours to receive a primary vaccination effects experienced following a primary
reduce the amount of paid time needed dose, in which case the additional time, vaccination dose. Additionally, if an
for vaccine administration (but not side as long as it is reasonable, would be employer does not specify between
effects) because of reduced employee considered unpaid but protected leave. different types of leave (i.e., employees
travel time. The employer cannot terminate the are granted only one type of leave), the
Paragraph (f)(1) specifies that the employee if they use a reasonable employer may require employees to use
amount of paid time that an employer amount of time to receive their primary that leave when recovering from
is required to provide each employee to vaccination doses. The employee may vaccination side effects. If an employer
receive each primary vaccination dose is use other leave time that they have provides employees with multiple types
capped at four hours. OSHA has available (e.g., sick leave or vacation of leave, such as sick leave and vacation
determined that four hours would time) to cover the additional time leave, the employer can only require
provide reasonable time for most needed to receive a vaccination dose employees to use the sick leave when
employees to get each vaccination dose. that would otherwise be unpaid. recovering from vaccination side effects.
Vaccines are widely available to the Paragraph (f)(2) also requires Employers cannot require employees to
public at clinics, pharmacies, and other employers to support COVID–19 use advanced sick leave to cover
locations across the country (see CDC, vaccination for each employee by reasonable time needed to recover from
October 8, 2021). Providing four hours providing reasonable time and paid sick vaccination side effects under paragraph
of paid time to receive each primary leave to recover from side effects (f)(2). An employer may not require an
vaccination dose is consistent with experienced following any primary employee to accrue negative paid sick
OSHA’s presumption of the amount of vaccination dose to each employee for leave or borrow against future paid sick
time needed to receive a vaccination each dose. The paid sick leave can be leave to recover from vaccination side
dose in the June 2021 Healthcare ETS in the form of an employee’s accrued effects. In other words, the employer
(86 FR 32598), and with the U.S. Office sick leave, if available. If the employee cannot require an employee to go into
of Personnel Management’s guidance to does not have available sick leave, leave the negative for paid sick leave if the
federal government agencies on the use must be provided for this purpose. employee does not have accrued paid
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61528 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
sick leave when they need to recover Bellew E et al. (2021, June). Half of service undermines vaccine campaign,
from side effects experienced following sector workers are not yet vaccinated for according to surveys, policy experts.
a primary vaccination dose. Neither the COVID–19: What gets in the way? The Washington Post. https://
Shift Project: Research Brief. https:// www.washingtonpost.com/us-policy/
paid time required to receive any shift.hks.harvard.edu/wp-content/ 2021/08/16/paid-leave-covid-vaccine/.
vaccine dose(s) nor the paid sick leave uploads/2021/06/Vax_Brief_6.28.21- (Rosenberg and Stein, August 18, 2021)
required to recover from side effects 2.pdf. (Bellew et al., June 2021) Roy B et al. (2020, December 29). Health Care
experienced following any vaccination Centers for Disease Control and Prevention Workers’ Reluctance to Take the COVID–
dose are retroactive requirements for (CDC). (2021, April 2). Post-vaccination 19 Vaccine: A Consumer-Marketing
vaccine dose(s) received prior to the considerations for workplaces. https:// Approach to Identifying and Overcoming
promulgation of this ETS. www.cdc.gov/coronavirus/2019-ncov/ Hesitancy.NEJM Catalyst. https://
community/workplaces-businesses/ catalyst.nejm.org/doi/pdf/10.1056/
Paragraph (f)(2) requires employers to vaccination-considerations-for- CAT.20.0676. (Roy et al., December 29,
provide reasonable time and paid sick workplaces.html. (CDC, April 2, 2021) 2020)
leave to employees to recover from side Centers for Disease Control and Prevention SEIU Healthcare. (2021, February 8).
effects experienced following a primary (CDC). (2021, September 30). Possible Research shows 81% of healthcare
vaccination dose, but does not specify side effects after getting a COVID–19 workers willing to take COVID–19
the amount of paid sick leave that the vaccine. https://www.cdc.gov/ vaccines but personal financial pressures
employer is required to provide for that coronavirus/2019-ncov/vaccines/expect/ remain a significant barrier for uptake.
after.html. (CDC, September 30, 2021) https://www.newswire.ca/news-releases/
purpose. Employers may set a cap on Centers for Disease Control and Prevention
the amount of paid sick leave available research-shows-81-of-healthcare-
(CDC). (2021, accessed October 8). We workers-willing-to-take-covid-19-
to employees to recover from any side can do this: Vaccines.gov website. vaccines-but-personal-financial-
effects, but the cap must be reasonable. https://www.vaccines.gov/. (CDC, pressures-remain-a-significant-barrier-
CDC notes that although some people October 8, 2021) for-uptake-888810789.html. (SEIU
have no side effects, side effects, if Cleveland Documenters. (2021). Why some Healthcare, February 8, 2021)
experienced, should go away in a few Clevelanders are still on the fence or not United States Bureau of Labor Statistics
getting vaccinated: Voices on the
days (CDC, September 30, 2021). vaccine. The Cleveland Observer.
(BLS). (2021, September). National
Another study found that the average Compensation Survey: Employee
https://www.freshwatercleveland.com/
unanticipated paid administrative leave Benefits in the United States, March
street-level/VaccineVoice050521.aspx.
required by individuals experiencing 2021. https://www.bls.gov/ncs/ebs/
(Cleveland Documenters, 2021)
benefits/2021/employee-benefits-in-the-
side effects was around two days (1.66 Kaiser Family Foundation (KFF). (2021, May
6). KFF COVID–19 Vaccine Monitor: united-states-march-2021.pdf. (BLS,
days for the first dose and 1.39 days for September, 2021)
the second dose) (Levi et al., September April 2021. https://www.kff.org/
coronavirus-covid-19/poll-finding/kff- United States Office of Personnel
25, 2021). Generally, OSHA presumes Management (OPM). (2021, April 29).
covid-19-vaccine-monitor-april-2021/.
that, if an employer makes available up (KFF, May 6, 2021) American Rescue Plan: COVID–19
to two days of paid sick leave per Kaiser Family Foundation (KFF). (2021, May Emergency Paid Leave for Federal
primary vaccination dose for side 17). How employer actions could Employees. https://chcoc.gov/sites/
effects, the employer would be in facilitate equity in COVID–19 default/files/
compliance with this requirement. vaccinations. https://www.kff.org/policy- Attachment%205%20COVID–
watch/how-employer-actions-could- 19%20Emergency%20Paid%20
When setting the cap, an employer
facilitate-equity-in-covid-19- Leave%20Questions%20
would not be expected to account for and%20Answers_0.pdf. (OPM, April 29,
vaccinations/. (KFF, May 17, 2021)
the unlikely possibility of the Kaiser Family Foundation (KFF). (2021, June 2021)
vaccination resulting in a prolonged 30). KFF COVID–19 Vaccine Monitor:
illness in the vaccinated employee (e.g., June 2021. https://www.kff.org/report-
G. COVID–19 Testing for Employees
a severe allergic reaction). section/kff-covid-19-vaccine-monitor- Who Are Not Fully Vaccinated
OSHA is aware that other federal, june-2021-findings/. (KFF, June 30, 2021) Paragraph (g) of this ETS addresses
state, or local laws, or collective Kaiser Family Foundation (KFF). (2021, employers’ obligations with respect to
bargaining agreements, may require September 28). KFF COVID–19 Vaccine employees who are not fully vaccinated,
Monitor: September 2021. https://
employers to provide employees including the requirement to ensure
www.kff.org/coronavirus-covid-19/poll-
additional paid time for vaccination finding/kff-covid-19-vaccine-monitor- unvaccinated employees are tested for
and/or paid sick leave to recover from september-2021/. (KFF, September 28, COVID–19. As explained in Need for the
vaccination side effects. Where such an 2021) ETS (Section III.B. of this preamble),
overlap exists, the requirements of this Levi ML et al. (2021, September 25). COVID– OSHA strongly prefers that employers
standard are satisfied so long as the 19 mRNA vaccination, reactogenicity, implement written mandatory
employer provides each employee work-related absences and the impact on vaccination policies because that is the
reasonable time and four hours of paid operating room staffing: A cross- most effective and efficient workplace
sectional study. Perioperative Care and
time to receive each primary control available for preventing the
Operating Room Management preprint.
vaccination dose, and reasonable time https://doi.org/10.1016/ spread of COVID–19. However, this ETS
and paid sick leave to recover from side j.pcorm.2021.100220. (Levi et al., is also necessary to protect workers who
effects experienced following a primary September 25, 2021) remain unvaccinated through required
vaccination dose. National Safety Council. (2021). A Year in regular testing, use of face coverings,
Review, and What’s Next: COVID–19 and removal of infected employees from
References Employer Approaches and Worker the workplace, and to protect other
Azimi T et al. (2021, April 9). Getting to Experiences. https://www.nsc.org/ workers from the greater likelihood that
work: Employers’ role in COVID–19 faforms/safer-year-one-final-report.
unvaccinated workers may spread
vaccination.1(Azimi et al., April 9, 2021) (National Safety Council, 2021)
Rosenberg E and Stein J. (2021, August 18). COVID–19 in the workplace. People
1 Azimi T et al. (2021, April 9). Getting to work: America’s failure to pay workers time off who are unvaccinated are at increased
Employers’ role in COVID–19 vaccination. https://
risk of becoming infected with COVID–
www.mckinsey.com/industries/pharmaceuticals- employers-role-in-covid-19-vaccination# (Azimi et 19 and are more likely to spread the
and-medical-products/our-insights/getting-to-work- al., April 9, 2021) disease when compared to people who
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61529
are fully vaccinated (CDC, September seeking monoclonal antibody treatment when appropriate. In addition to being
15, 2021). Additionally, people who are or anti-viral medication). Although the more likely to become infected with
unvaccinated are more likely to testing required in paragraph (g)(1) of COVID–19, people who are
experience severe clinical outcomes if this ETS is screening testing, both unvaccinated are more likely to
they become infected than people who screening and diagnostic testing can experience severe clinical outcomes
are vaccinated (Lopez Bernal et al., July help prevent the spread of COVID–19. from COVID–19 than fully vaccinated
21, 2021). Therefore, routine COVID–19 Paragraph (g) does not preclude people (see Grave Danger, Section III.A.
testing of unvaccinated employees is additional diagnostic testing if an of this preamble). In a recent CDC
necessary to identify employees with employee shows signs or symptoms Morbidity and Mortality Weekly Report
COVID–19 so they can be removed from consistent with COVID–19 or has recent (MMWR) out of Los Angeles County, the
the workplace to prevent transmission known or suspected exposure to SARS– SARS–CoV–2 infection rate among
to other employees and to facilitate CoV–2. unvaccinated persons was 4.9 times and
early medical intervention for infected Both screening and diagnostic testing the hospitalization rate was 29.2 times
employees when appropriate. involve the use of viral COVID–19 tests the rates among fully vaccinated
Routine testing of unvaccinated to detect current infection, as opposed persons (Griffin et al., August 27, 2021).
employees is necessary regardless of to antibody COVID–19 tests, which are As explained below, regular screening
whether the unvaccinated employees used to detect whether a person has testing of individuals for COVID–19 is
have symptoms because SARS–CoV–2 antibodies for COVID–19. A positive an effective method of identifying
infection is often attributable to antibody test indicates someone has asymptomatic and pre-symptomatic
asymptomatic and/or pre-symptomatic antibodies to SARS–CoV–2, the virus infections. Screening testing of
transmission (i.e., individuals who are that causes COVID–19, which could unvaccinated employees is necessary
not exhibiting symptoms) (Bender et al., either be the result of a prior infection because symptom and temperature
February 18, 2021; Klompas, September with the virus or vaccination against checks will miss both asymptomatic and
2021; Johansson et al., January 7, 2021; COVID–19 (FDA, May 19, 2021; CDC, pre-symptomatic infections, which is a
Byambasuren et al., December 11, 2020). September 10, 2021). Viral tests for serious problem because pre-
Although less effective and efficient current infection fall into two symptomatic and asymptomatic
than vaccination, the CDC has categories: Nucleic acid amplification transmission are significant drivers of
recognized regularly testing tests (NAATs) and antigen tests. The the continued spread of COVID–19
unvaccinated employees for COVID–19 Food and Drug Administration (FDA) (Johansson et al., January 7, 2021). Once
as a useful tool for identifying (October 6, 2021) has issued a number infected employees are identified, they
asymptomatic and/or pre-symptomatic of Emergency Use Authorizations can be removed from the workplace,
infected individuals so that they can be (EUAs) for viral COVID–19 tests. It is thereby reducing virus transmission to
isolated (CDC, May 4, 2021; CDC, important to note that OSHA’s other employees.
October 7, 2021). In contrast, the CDC definition of ‘‘COVID–19 test’’ requires
recommends that fully vaccinated that COVID–19 tests be cleared, Several studies have indicated that
employees with no symptoms and no approved, or authorized by the FDA and the time from exposure to becoming
known exposure should be exempt from administered in accordance with contagious for COVID–19 is shorter than
routine testing programs (CDC, May 4, authorized instructions, with the noted the time for symptoms to develop
2021). Additional information about the exception of not allowing tests that are (incubation period), meaning that
risks of COVID–19 transmission in both self-administered and self-read by individuals can transmit SARS–CoV–2
vaccinated and unvaccinated workers is the employee unless observed by the before they begin to feel ill (i.e., pre-
discussed in Grave Danger (Section employer or an authorized telehealth symptomatic transmission) (Nishiura et
III.A. of this preamble). proctor. In this regard, OSHA recognizes al., March 4, 2020; Tindale et al., June
Testing for COVID–19 can broadly be that it is within FDA’s authority and 22, 2020). Pre-symptomatic individuals
divided into two categories: diagnostic jurisdiction to help to assure the can transmit the virus to others before
testing and screening testing. The appropriate safety, efficacy, and they know they are sick. These
purpose of diagnostic testing is to accuracy of COVID–19 tests. The individuals should isolate but would
identify current infection when a person definition of ‘‘COVID–19 test’’ has not know to do so if they are unaware
has signs or symptoms consistent with previously been discussed in the of their infection. It is also possible for
COVID–19, or when a person is Summary and Explanation for individuals to be infected and
asymptomatic but has recent known or paragraph (c) (Section VI.C. of this subsequently transmit the virus without
suspected exposure to SARS–CoV–2. preamble). Additional information ever exhibiting symptoms. This is called
The information provided by diagnostic about the type of COVID–19 tests that asymptomatic transmission. A meta-
testing can be used by a healthcare would satisfy the requirements of analysis of 351 studies from January 1,
provider to diagnose or treat a patient. paragraph (g) are available in that 2020, to April 2, 2021, estimated that
The purpose of screening testing is to section of this preamble. 42.8% of those infected with the SARS–
identify infected people who are As explained above, the most effective CoV–2 virus exhibited no symptoms at
asymptomatic and do not have known, and efficient workplace control for the time of testing and so had either
suspected, or reported exposure to preventing the spread of COVID–19 is asymptomatic or pre-symptomatic
COVID–19. Screening testing helps to vaccination and OSHA strongly prefers infections (Sah et al., August 10, 2021).
identify unknown cases both so that that employers implement written In another meta-analysis of studies,
measures can be taken to prevent further mandatory vaccination policies. which included people of all ages at risk
transmission to others (e.g., removal However, where employers have of contracting COVID–19 who were
from the workplace and home isolation) unvaccinated employees, regular tested regardless of presence or absence
and also to allow infected, but COVID–19 screening tests are necessary of symptoms, seventeen percent of cases
asymptomatic, people to begin medical so infected employees can be identified never developed symptoms during
treatment, as appropriate, so they can and removed from the workplace to entire COVID–19 infection (i.e.,
better avoid the most severe outcomes of prevent workplace transmission and to asymptomatic infection). In those
COVID–19 (e.g., high risk individuals facilitate early medical intervention, studies, a diagnosis was confirmed with
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61530 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
a positive result on a RT–PCR and all 2021). In a study with a well-defined frequently based on factors such as the
positive cases had a follow-up period of population of SARS–CoV–2 infected level of community transmission,
at least seven days to distinguish individuals, researchers found that workplace experience with outbreaks,
asymptomatic cases from pre- frequent testing (i.e., at least twice per and type of workplace (e.g., specific
symptomatic cases (Byambasuren et al., week) maximizes the likelihood of workplace factors such as high volume
December 11, 2020). In another study, detecting infected individuals. retail or critical infrastructure sector).
researchers used a decision analytical However, even when used weekly, rapid Early detection of COVID–19-positive
model to assess the proportion of antigen tests still had a 76% probability employees through screening testing of
SARS–CoV–2 transmission from pre- of detection (i.e., weekly rapid antigen unvaccinated employees also facilitates
symptomatic, never symptomatic, and tests correctly identified 76% of true early medical intervention, when
symptomatic individuals in the positive infected COVID–19 appropriate, to avoid the most severe
community. Based on their modeling, individuals) (Smith et al., September 15, health outcomes associated with
they predicted that 59% of transmission 2021). By identifying pre-symptomatic COVID–19. Early effective treatment of
came from asymptomatic transmission, and asymptomatic unvaccinated disease can help avert progression to
including 35% from pre-symptomatic employees, employers can remove them more serious illness, especially for
individuals and 24% from individuals from the workplace to prevent those patients at high risk of disease
who never develop symptoms employees from spreading SARS–CoV– progression and severe illness, with the
(Johansson et al., January 7, 2021). 2 to other employees. More information additional benefit of reducing the
The existence of pre-symptomatic and about the removal requirements in this burden on healthcare systems (CDC,
asymptomatic infections pose serious ETS is available in the Summary and December 4, 2021). For example, anti-
challenges to containing the spread of Explanation for paragraph (h) (Section SARS–CoV–2 monoclonal antibodies
SARS–CoV–2. Although the risk of VI.H. of this preamble). have been shown to reduce the risk of
asymptomatic transmission is 42% hospitalization and death in the
Since the incubation period for
lower than from symptomatic COVID– outpatient setting in those with mild to
COVID–19 can be up to 14 days, the
19 patients (Byambasuren et al., moderate COVID–19 symptoms and
CDC recommends that screening testing
December 11, 2020), asymptomatic certain risk factors for disease
be conducted at least weekly in non-
transmission may result in more progression. Treatment should be
healthcare workplaces (CDC, October 7,
transmissions than symptomatic cases started as soon as possible after the
2021; CDC, May 4, 2021). Other patient receives a positive result on a
because asymptomatic persons are less
likely to be aware of their infection and researchers also recognize the COVID–19 test and within 10 days of
can unknowingly continue to spread the effectiveness of weekly screening testing symptom onset (NIH, September 24,
disease to others (Sah et al., August 10, to control surges of COVID–19 2021). Any COVID–19 medical
2021). The challenge of containing pre- infections (Larremore, January 1, 2021). treatment should be used in accordance
symptomatic and asymptomatic SARS– Consequently, in workplaces with with a licensed healthcare provider. The
CoV–2 transmission is amplified among unvaccinated employees, OSHA has set screening tests required by this rule will
unvaccinated individuals because, as the minimum frequency of testing facilitate such treatment.
explained above, they are more likely to unvaccinated workers at seven days Pursuant to paragraph (g)(1)(i),
become infected with COVID–19 in the because the agency expects that it will covered employers must ensure that
first place. be effective in slowing the spread of each employee who is not fully
Because unvaccinated employees are COVID–19 in those workplaces, when vaccinated and reports at least once
at higher risk of COVID–19 infection used in tandem with face coverings every seven days to a workplace where
and COVID–19 transmission among (paragraph (i)) and removal of infected other individuals (e.g., coworkers,
individuals without symptoms is a individuals (paragraph (h)). OSHA customers) are present: (A) Is tested for
significant driver of the spread of emphasizes that each of these infection COVID–19 at least once every seven
COVID–19, OSHA has determined it is controls provides some protection from days; and (B) provides documentation of
necessary to prevent the pre- COVID–19 by itself, but that they work the most recent COVID–19 test result to
symptomatic and asymptomatic best when used together, layering their the employer no later than the 7th day
transmission of COVID–19 from protective impact to boost overall following the date on which the
unvaccinated workers, through a effectiveness. Although some studies employee last provided a test result.
requirement for weekly screening have shown that more regular screening Employers must ensure these
testing. Screening testing with antigen testing (e.g., twice weekly) would unvaccinated employees are tested at
tests is a rapidly evolving and important identify even more cases, OSHA has least once every seven calendar days,
tool that can be used to reduce the decided to require testing only on a regardless of their work schedule. For
spread of SARS–CoV–2 in the weekly basis. This is in line with the example, an unvaccinated part-time
workplace, particularly when coupled CDC recommendations, and as noted employee who is scheduled to work
with other COVID–19 prevention and above the evidence shows that this only every Monday and Tuesday must
control measures (e.g., workplace frequency is effective in detecting still be tested at least once every seven
removal of infected persons, proper use asymptomatic and pre-symptomatic days. Because employees must provide
of face coverings) (Schulte et al., May cases. A more frequent testing schedule documentation of their most recent
19, 2021). The CDC recommends would result in significant additional COVID–19 test results to their
screening testing of unvaccinated costs, and OSHA is hesitant to impose employers no later than the 7th day
asymptomatic workers as a useful tool these costs and depart from CDC following the date on which they last
to detect COVID–19 and stop recommendations without a fuller provided a test result, employees may
transmission quickly. Screening testing record generated through the benefit of want to set a schedule for their testing
is particularly useful in areas with notice and comment rulemaking. OSHA (e.g., get a COVID–19 test every
moderate to high community seeks comment on this issue. Wednesday). A consistent testing day
transmission of COVID–19, which is Nonetheless, it should be noted that may help employees ensure their
currently the overwhelming majority of nothing in this rule prevents screening documentation is provided every seven
the United States (CDC, October 7, testing from being conducted more calendar days.
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61531
Paragraph (g)(1)(ii) addresses must specify how testing will be antigen testing should not result in an
situations where an employee does not conducted (e.g., testing provided by the inability to provide the employer with
report to a workplace where other employer at the workplace, employees test results in a timely fashion.
individuals, such as coworkers or independently scheduling tests at point- However, the agency recognizes that
customers, are present during a period of-care locations, etc.). The employer where the employee or employer uses
of seven or more days (e.g., when an must also specify in their policy how an off-site laboratory for testing, there
employee is teleworking for an extended employees should provide their COVID– may be delays beyond the employee’s or
period of time). In such cases, the 19 test results to the employer (e.g., an employer’s control. In the event that
employer must ensure the employee is online portal, to the human resources there is a delay in the laboratory
tested for COVID–19 within seven days department). The Summary and reporting results and the employer
prior to returning to the workplace and Explanation for paragraph (d) (Section permits the employee to continue
provides documentation of that test VI.D. of this preamble) provides working, OSHA will look at the pattern
result to the employer upon return to additional information regarding the and practice of the individual employee
the workplace. For example, if an requirements of paragraph (d)(2) of this or the employer’s testing verification
unvaccinated office employee has been ETS. Test results given to the employer process and consider refraining from
teleworking for two weeks but must must contain information that identifies enforcement where the facts show good
report to the office, where other the worker (i.e., full name plus at least faith in attempting to comply with the
employees will be present (e.g., one other identifier, such as date of standard.
coworkers, security officers, mailroom birth), the specimen collection date, the OSHA has determined that employers
workers), on a specific Monday to copy type of test, the entity issuing the result may use pooling procedures to satisfy
and fax documents, that employee must (e.g., laboratory, healthcare entity), and the requirements of screening testing
receive a COVID–19 test within the the test result. under paragraph (g)(1). Pooling (also
seven days prior to the Monday and If an employer is notified that an referred to as pool testing or pooled
provide documentation of that test employee has a positive screening test, testing) means combining the same type
result to the employer upon return to the employer must remove that of specimen from several people and
the workplace. The employee’s test employee from the workplace pursuant conducting one laboratory test on the
must occur within the seven days before to paragraph (h)(2) of this ETS. The combined pool of specimens to detect
the Monday the employee is scheduled employee should quarantine and the SARS–CoV–2 (e.g., four samples may be
to report to the office, but it also must employer must not allow the employee tested together, using only the resources
happen early enough to allow time for to return to the workplace until they needed for a single test). The advantages
the results to be received before meet the requirements in paragraphs of pooling include preserving testing
returning to the workplace. Similarly, (h)(2)(i) through (iii). More discussion of resources, reducing the amount of time
unvaccinated new hires would need to employee notification to their employer required to test large numbers of
be tested for COVID–19 within seven of a COVID–19 positive status and specimens (increasing throughput), and
days prior to reporting to a workplace removal requirements is available in the lowering the overall cost of testing
where other employees will be present Summary and Explanation for (CDC, June 30, 2021).
and provide documentation of their test paragraph (h) (Section VI.H. of this If pooling procedures are used and a
results no later than arrival on their first preamble). pooled test result comes back negative,
day of work. Since point-of-care testing OSHA expects that most screening then all the specimens can be presumed
that uses an antigen test allows for testing will be antigen testing that is negative with the single test. In other
results within minutes, OSHA does not conducted at point-of-care locations due words, all of the employees who
expect that scheduling tests or to the reduced cost and faster processing provided specimens for that pool test
providing results to employers will be time when compared to NAAT testing can be assumed to have a negative test
an impediment. in laboratories. Most NAATs need to be result for SARS–CoV–2 infection.
OSHA chose the seven-day period for processed in a laboratory with variable Therefore, documentation of the
employees returning to work after more time to results (approximately 1–2 negative pooled test result would satisfy
than a week away from the workplace days). In contrast, most antigen tests can the paragraph (g)(1) documentation
based on the evidence noted above be processed at the point of care with requirement for each employee in the
about the effectiveness of testing at results available in about 15–30 minutes pool and no additional testing is
seven-day intervals. While it considered (CDC, October 7, 2021). Rapid point-of- necessary. However, if the pooled test
using a shorter time period in this care tests are administered in various result is positive, immediate additional
situation, OSHA concluded that it settings, such as: Physician offices, testing would be necessary to determine
would be less confusing for employers urgent care facilities, pharmacies, which employees are positive or
to use a uniform time period for both school health clinics, workplace health negative. Each of the original specimens
situations. OSHA was concerned that clinics, long-term care facilities and collected in the pool must be tested
requiring different time periods in the nursing homes, and at temporary individually to determine which
two situations would cause confusion locations, such as drive-through sites specimen(s) is (are) positive. If original
among both employees and supervisors managed by local organizations. As specimens from the workers in a pooled
implementing the program that would explained above, COVID–19 tests that test with a positive result are
undermine the effectiveness of the are both self-administered and self-read insufficient to be subsequently tested
testing scheme. OSHA seeks comment do not meet the definition of ‘‘COVID– individually, those workers in the
on this issue. 19 test’’ in this ETS (unless observed by positive pool would need to be
An employer has some discretion the employer or an authorized immediately re-swabbed and tested. The
regarding how to satisfy its obligations telehealth proctor) and therefore do not individual employee test results would
under paragraph (g)(1), but those satisfy the testing requirements of be necessary to satisfy the employee
policies and procedures must be paragraph (g). documentation requirements of
detailed in the employer’s written Because antigen testing in point-of- paragraph (g)(1). Where pooled testing is
policy pursuant to paragraph (d)(2) of care locations will typically produce used (in accordance with paragraph
this ETS. For example, the employer results within minutes, the use of (g)(1)), CDC and FDA procedures and
App. 131
61532 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
recommendations for implementing ETS to strongly encourage vaccination, consult the Equal Employment
screening pooled tests should be requiring employers to bear the costs of Opportunity Commission’s website:
followed (CDC, June 30, 2021; FDA, COVID–19 testing would be counter- https://www.eeoc.gov/wysk/what-you-
August 24, 2020). OSHA notes that only productive. As mentioned above, should-know-about-covid-19-and-ada-
some tests are authorized for pooled requiring employers to pay for rehabilitation-act-and-other-eeo-laws.
testing, and should be performed per the workplace protections makes it more Pursuant to paragraph (g)(2), if an
authorization. likely that employees will take employee does not provide the result of
In a note to paragraph (g)(1), OSHA advantage of that protection, and in this a COVID–19 test as required by
explains that this section does not ETS, OSHA intends to strongly paragraph (g)(1), the employer must
require the employer to pay for any encourage employees to choose keep the employee removed from the
costs associated with testing. As vaccination, not regular COVID–19 workplace until the employee provides
explained in Pertinent Legal Authority, testing. Because employees who choose a test result. This provision is
Section II. of this preamble, the OSH to remain unvaccinated will generally imperative because workers with
Act authorizes OSHA to require be required to pay for their own COVID– asymptomatic or pre-symptomatic
employers to bear the costs of 19 testing, this standard creates a SARS–CoV–2 infection are significant
compliance with occupational safety financial incentive for those employees contributors to COVID–19 transmission,
and health standards, but OSHA has to become fully vaccinated and avoid and screening testing will help to
discretion to decide whether to impose that cost. identify and remove those individuals
certain costs—such as those related to from the workplace. Employees
Although this ETS does not require
medical examinations or other tests—on providing accurate and weekly test
employers to pay for testing, employer
employers ‘‘[w]here [it determines that results to their employer is of utmost
payment for testing may be required by
such costs are] appropriate.’’ 29 U.S.C. importance for preventing and reducing
other laws, regulations, or collective
655(b)(7). OSHA has commonly the transmission of COVID–19 in the
bargaining agreements or other
required employers to bear the costs of workplace.
collectively negotiated agreements. This Paragraph (g)(3) provides that when
compliance with standards as a cost of
section also does not prohibit the an employee has received a positive
doing business, including requiring
employer from paying for costs COVID–19 test, or has been diagnosed
employers to bear the costs of medical
associated with testing required by with COVID–19 by a licensed healthcare
examinations and procedures (see, e.g.,
paragraph (g)(1) of this section. provider, the employer must not require
29 CFR 1910.1018(n)(1)(i) (inorganic
arsenic standard requires employers to Otherwise, the agency leaves the that employee to undergo COVID–19
ensure that medical examinations and decision regarding who pays for the testing for 90 days following the date of
procedures are provided ‘‘without cost testing to the employer. Because OSHA their positive test or diagnosis. This
to the employee’’); see also United does not specify who pays for the provision is specifically intended to
Steelworkers, 647 F.2d at 1229–31 testing, OSHA expects that some prohibit screening testing for 90 days
(discussing Lead standard’s medical workers and/or their representatives because of the high likelihood of false
removal provisions and OSHA’s will negotiate the terms of payment. positive results that do not indicate
authority for imposing cost of medical OSHA has also considered that some active infection but are rather a
removal on employers)). Requiring employers may choose to pay for some reflection of past infection. Studies of
employers to bear the costs of or all of the costs of testing as an patients who were hospitalized and
compliance makes it more likely that inducement to keep employees in a tight recovered indicate that SARS–CoV–2
employees will take advantage of labor market. Other employers may RNA can be detected in upper
workplace protections (see 86 FR choose to put the full cost of testing on respiratory tract specimens for up to
32605). For example, employees are employees in recognition of the three months (90 days) after symptom
more likely to use personal protective employee’s decision not to become fully onset (CDC, August 2, 2021; CDC,
equipment (PPE) when employers vaccinated. It is also possible that some September 14, 2021). If employees were
provide the PPE to their employees at employers may be required to cover the to be subjected to screening tests in such
no cost (see 72 FR 64342, 64344). cost of testing for employees pursuant to a situation it would both undermine the
In this ETS, OSHA has largely other laws or regulations. OSHA notes, confidence in the COVID–19 screening
required employers to bear the costs of for instance, that in certain tests and could result in a harm to the
compliance, including the typical costs circumstances, the employer may be worker of being unnecessarily removed
associated with vaccination, but has required, under the Fair Labor from the workplace and subjected to the
determined that it would not be Standards Act, to pay for the time it additional burden of unnecessary tests.
appropriate to impose on employers any takes an employee to be tested (e.g., if Where employers implement a
costs associated with COVID–19 testing employee testing is conducted in the vaccination policy that allows
for employees who choose not to be middle of a work shift). The subject of employees to choose to provide proof of
vaccinated. As explained in Need for payment for the costs associated with regular testing and wear a face covering
the ETS, Section III.B. of this preamble, testing pursuant to other laws or rather than getting vaccinated, the
this ETS is designed to strongly regulations not associated with the OSH employer’s policy and procedures to
encourage vaccination because Act is beyond OSHA’s authority and implement this temporary suspension of
vaccination is the most efficient and jurisdiction. As explained in a note to testing must be included in their written
effective control for protecting paragraph (d) of this ETS, under various workplace policy as required by
unvaccinated workers from the grave anti-discrimination laws, workers who paragraph (d)(2) of this ETS.
danger posed by COVID–19. COVID–19 cannot be tested because of a sincerely Paragraph (g)(4) provides that the
testing is only required under the ETS held religious belief may ask for a employer must maintain a record of
where an employee has made an reasonable accommodation from their each test result required to be provided
individual choice to forgo vaccination employer. For more information about by each employee under paragraph
and pursue a less protective option. evaluating requests for reasonable (g)(1) of this ETS or obtained during
Given the superior protectiveness of accommodation for a sincerely held tests conducted by the employer. These
vaccination, and OSHA’s intent for this religious belief, employers should records must be maintained in
App. 132
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61533
accordance with 29 CFR 1910.1020 as Canada. 5(4): 223–234 doi:10.3138/ Food and Drug Administration (FDA). (2021,
an employee medical record and must jammi-2020–0030. (Byambasuren et al., October 6). In Vitro Diagnostics EUAs.
not be disclosed except as required by December 11, 2020). https://www.fda.gov/medical-devices/
Centers for Disease Control and Prevention coronavirus-disease-2019-covid-19-
this ETS or other federal law. However, (CDC). (2020, December 4). Information emergency-use-authorizations-medical-
these records are not subject to the for Clinicians on Investigational devices/in-vitro-diagnostics-euas. (FDA,
retention requirements of 29 CFR Therapeutics for Patients with COVID– October 6, 2021).
1910.1020(d)(1)(i) (Employee medical 19. https://www.cdc.gov/coronavirus/ Griffin JB et al. (2021, August 27). SARS–
records), but must be maintained and 2019-ncov/hcp/therapeutic-options.html. CoV–2 infections and hospitalizations
preserved while this ETS remains in (CDC, December 4, 2020). among persons aged ≥16 years, by
effect. Centers for Disease Control and Prevention vaccination status—Los Angeles County,
Additionally, paragraph (l) of this ETS (CDC). (2021, May 4). Antigen Testing for California, May 1–July 25, 2021. MMWR
includes specific timeframes for Screening in Non-Healthcare 70: 1170–1176. http://dx.doi.org/
Workplaces: A tool to prevent the spread 10.15585/mmwr.mm7034e5. (Griffin et
providing access to records, including of COVID–19. https://www.cdc.gov/ al., August 27, 2021).
the COVID–19 test results required by coronavirus/2019-ncov/community/ Johansson MA et al. (2021, January 7). SARS–
paragraph (g)(1). As a result, the workplaces-businesses/antigen- CoV–2 transmission from people without
timeframes for providing access to testing.html. (CDC, May 4, 2021). COVID–19 symptoms. JAMA Network
employee medical records in 29 CFR Centers for Disease Control and Prevention Open. 4(1): e2035057. doi:10.1001/
1910.1020(e) do not apply. Instead, (CDC). (2021, June 30). Interim Guidance jamanetworkopen.2020.35057.
when providing access to an employee, for Use of Pooling Procedures in SARS– (Johansson et al., January 7, 2021).
CoV–2 Diagnostic and Screening Testing. Klompas M et al., (2021, September). The
anyone with written authorized consent https://www.cdc.gov/coronavirus/2019-
from that employee, and OSHA, case for mandating COVID–19 vaccines
ncov/lab/pooling-procedures.html. (CDC, for health care workers. Annals of
employers must follow the access June 30, 2021). Internal Medicine. https://doi.org/
timeframes set forth in paragraph (l) of Centers for Disease Control and Prevention 10.7326/M21-2366. (Klompas et al.,
this ETS. The Summary and (CDC). (2021, August 2). COVID–19 September 2021).
Explanation for paragraph (l) (Section Testing Overview. https://www.cdc.gov/ Larremore DB et al. (2021, January 1). Test
VI.L. of this preamble) contains coronavirus/2019-ncov/symptoms- sensitivity is secondary to frequency and
testing/testing.html. (CDC, August 2,
additional information about accessing 2021).
turnaround time for COVID–19
records gathered pursuant to paragraph screening. Sci Adv 2021; 7(1): eabd5393.
Centers for Disease Control and Prevention https://doi.org/10.1126/sciadv.abd5393.
(g)(1). (CDC). (2021, September 10). Using
Finally, while the access timeframes (Larremore, January 1, 2021).
Antibody Tests for COVID–19. https://
Lopez Bernal et al. (2021, July 21).
in 29 CFR 1910.1020(e) and retention www.cdc.gov/coronavirus/2019-ncov/
Effectiveness of COVID–19 vaccines
requirements of 29 CFR lab/resources/antibody-tests.html. (CDC,
against the B.1.617.2 (Delta) variant. The
1910.1020(d)(1)(i) do not apply to test September 10, 2021).
New England Journal of Medicine,
result records required by this ETS, the Centers for Disease Control and Prevention
385(7), 585–594. https://doi.org/10.1056/
other provisions in 29 CFR 1910.1020 (CDC). (2021, September 14). Ending
Isolation and Precautions for People with NEJMoa2108891. (Lopez Bernal, July 21,
do apply. For example, 29 CFR COVID–19: Interim Guidance. https:// 2021).
1910.1020(h) includes requirements for www.cdc.gov/coronavirus/2019-ncov/ National Institutes of Health (NIH). (2021,
the transfer of employee medical hcp/duration-isolation.html. (CDC, September 24). Therapeutic Management
records when an employer ceases to do September 14, 2021). of Nonhospitalized Adults With COVID–
19. https://www.covid19treatmentguide
business. Like the vaccine records Centers for Disease Control and Prevention
(CDC). (2021, September 15). Science lines.nih.gov/management/clinical-
required by paragraph (e)(4) of this ETS, management/nonhospitalized-adults--
and because they concern the health Brief: COVID–19 Vaccines and
Vaccination. https://www.cdc.gov/ therapeutic-management/. (NIH,
status of an employee, test result records September 24, 2021).
coronavirus/2019-ncov/science/science-
required by paragraph (g)(1) are briefs/fully-vaccinated-people.html. Nishiura H et al. (2020, March 4). Serial
employee medical records for purposes (CDC, September 15, 2021). interval of novel coronavirus (COVID–
of 29 CFR 1910.1020. These test result Centers for Disease Control and Prevention 19) infections. Int J Infect Dis. 2020 Apr;
records contain personally identifiable (CDC). (2021, October 7) Interim 93: 284–286. doi:10.1016/
medical information and must be Guidance for SARS–CoV–2 Testing in j.ijid.2020.02.060. Epub 2020 Mar 4.
Non-Healthcare Workplaces. https:// PMID: 32145466; PMCID: PMC7128842.
maintained in a confidential manner.
www.cdc.gov/coronavirus/2019-ncov/ (Nishiura et al., March 4, 2020).
The Summary and Explanation for Sah P et al. (2021, August 10). Asymptomatic
paragraph (e) (Section VI.E. of this community/organizations/testing-non-
healthcare-workplaces.html. (CDC, SARS–COV–2 infection: A systematic
preamble) contains additional October 7, 2021). review and meta-analysis. Proceedings of
information about the interplay between Food and Drug Administration (FDA). (2020, the National Academy of Sciences,
this ETS and OSHA’s regulation at 29 August 24). Pooled Sample Testing and 118(34), 1–12. https://doi.org/10.1073/
CFR 1910.1020. Screening Testing for COVID–19. https:// pnas.2109229118. (Sah et al., August 10,
www.fda.gov/medical-devices/ 2021).
References coronavirus-covid-19-and-medical- Schulte P et al. (2021, May 19). Proposed
Bender et al., (2021, February 18). Analysis devices/pooled-sample-testing-and- Framework for Considering SARS–CoV–
of Asymptomatic and Presymptomatic screening-testing-covid-19. (FDA, August 2 Antigen Testing of Unexposed
Transmission in SARS–CoV–2 Outbreak, 24, 2020). Asymptomatic Workers in Selected
Germany, 2020. https://wwwnc.cdc.gov/ Food and Drug Administration (FDA). (2021, Workplaces. J Occup Environ Med. 2021
eid/article/27/4/20-4576_article. (Bender May 19). Antibody Testing Is Not Aug; 63(8): 646–656. Published online
et al., February 18, 2021). Currently Recommended to Assess 2021, May 19. https://www.ncbi
Byambasuren O et al. (2020, December 11). Immunity After COVID–19 Vaccination: .nlm.nih.gov/pmc/articles/PMC8327768/
Estimating the extent of asymptomatic FDA Safety Communication. https:// . (Schulte et al., May 19, 2021).
COVID–19 and its potential for www.fda.gov/medical-devices/safety- Smith R et al. (2021, September 15).
community transmission: Systematic communications/antibody-testing-not- Longitudinal assessment of diagnostic
review and meta-analysis. Official currently-recommended-assess- test performance over the course of acute
Journal of the Association of Medical immunity-after-covid-19-vaccination- SARS–CoV–2 infection. The Journal of
Microbiology and Infectious Disease fda-safety. (FDA, May 19, 2021). Infectious Diseases; 224(6), 976–982.
App. 133
61534 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
https://doi.org/10.1093/infdis/jiab337. notification requirements in this requirement in paragraph (h)(2) to
(Smith et al., September 15, 2021). paragraph, is to reduce transmission of remove, from the workplace, any
Tindale LC et al. (2020, June 22). Evidence COVID–19 in the workplace, employees employee who receives a positive
for transmission of COVID–19 prior to
are required to notify the employer of COVID–19 test or is diagnosed with
symptom onset. Elife. 2020; 9: e57149.
Published 2020 Jun 22. doi:10.7554/ any COVID–19 positive test or diagnosis COVID–19. It is important to remove
eLife.57149. (Tindale et al., June 22, that they receive, not just positive employees who test positive or are
2020). results that are received from testing diagnosed with COVID–19 from the
required under paragraph (g) of this workplace as soon as possible to prevent
H. Employee Notification to Employer of ETS. the transmission of COVID–19 to other
a Positive COVID–19 Test and Removal Paragraph (h)(1) states that the employees. Therefore, the requirement
Employers can substantially reduce employer must require each employee that employees promptly inform their
disease transmission in the workplace who is COVID–19 positive to notify the employer of a positive COVID–19 test
by removing employees who are employer of their COVID–19 test result result or COVID–19 diagnosis is
confirmed to have COVID–19 based on or diagnosis ‘‘promptly.’’ For employees necessary because this information
a COVID–19 test or diagnosis by a who are not at the workplace when they allows the employer to take actions to
healthcare provider. It is necessary that receive a positive COVID–19 test result protect other employees, including most
employees who are confirmed to have or diagnosis, ‘‘promptly’’ notifying the critically by removing employees whose
COVID–19 be removed from the employer means notifying the employer illness poses a direct threat of infection
workplace to prevent transmission to as soon as practicable before the to other employees in the workplace.
other employees. Several studies have employee is scheduled to start their Paragraph (h)(2) requires employers to
focused on the impact of isolating shift or return to work. In the event that immediately remove from the workplace
persons with COVID–19 from others the employee is in the workplace when any employee, regardless of vaccination
during their likely known infectious they receive a positive COVID–19 test status, who receives a positive COVID–
period, and those studies show that result or diagnosis of COVID–19, 19 test or is diagnosed with COVID–19
isolation is a strategy that reduces the ‘‘promptly’’ notifying the employer by a licensed healthcare provider.
transmission of infections. For example, means notifying the employer as soon as OSHA determined that directing an
Kucharski et al. (2020) found that safely possible while avoiding exposing employee who tests positive or is
transmission of SARS–CoV–2 would any other individuals in the workplace. diagnosed with COVID–19 to stay home
decrease by 29% with self-isolation The employer should establish until return to work criteria are
within the household, which would notification procedures and inform achieved is critical to preventing the
extend to 37% if the entire household employees about these procedures (see transmission of COVID–19 in the
quarantined. Similarly, Wells et al. paragraph (j)(1)), so that employees are workplace. Similar to the notification
(2021) found that isolation of aware of the appropriate method for required in paragraph (h)(1), this
individuals at symptom onset would providing this notification to their removal must occur regardless of
decrease the reproductive rate (R0) of employer. These notification procedures employee vaccination status since
COVID–19 from 2.5 to 1.6. Lastly, can be based on the employer’s current someone who is fully vaccinated can
Moghadas et al. (2020) reported results protocols for employees to notify the still transmit COVID–19 to others,
that highlight the role of silent employer if they are not able to come to including other employees (see Grave
transmission, from a combination of the work or need to leave work because of Danger, Section III.A. of this preamble).
pre-symptomatic stage and illness or injury. However the employer OSHA notes that, in most
asymptomatic infections, as the primary chooses to implement its notification circumstances, any positive COVID–19
driver of COVID–19 outbreaks and procedures, it must ensure that an test would result in removal. However,
underscore the need for mitigation employee notification of a positive this is not necessarily the case where an
strategies, including those that detect COVID–19 test or diagnoses results in employer uses pooled COVID–19
and isolate infectious individuals prior the employee’s immediate removal from testing, a method where one laboratory
to the onset of symptoms. Isolating the workplace, as required under test is conducted using the specimens of
contagious employees from their co- paragraph (h)(2). For example, the several people to detect the virus that
workers can prevent further spread at employer may require employees to causes COVID–19 (CDC, June 30, 2021).
the workplace and safeguard the health report any positive COVID–19 test or If an employer conducts pooled testing
of other employees. diagnosis to a company supervisor with for COVID–19, a positive pooled test
Paragraph (h) provides that employers the authority to temporarily remove the result would trigger a need to
must require each employee to promptly employee from the workplace. If an immediately re-test those employees in
notify the employer when the employee employer takes all steps required under the pool using an individual COVID–19
receives a positive COVID–19 test or is this paragraph but an employee fails to test because the positive pooled result
diagnosed with COVID–19 by a licensed report required information, the ETS would not satisfy the requirements of
healthcare provider. This notification does not dictate that any disciplinary paragraph (g). Only those employees
must occur regardless of employee action be taken against the employee. If who test positive on their individual re-
vaccination status. As discussed in an employer is cited by OSHA under test would need to be removed from the
Grave Danger (Section III.A. of this this provision under such workplace.
preamble), exposure to SARS–CoV–2 in circumstances, the employer is entitled OSHA intends ‘‘removal’’ under
the workplace presents a grave danger to to contest the citation if it can establish paragraph (h)(2) to refer only to the
employees; removing those who are an employee misconduct defense in temporary removal from the workplace
confirmed to have COVID–19 from the accordance with applicable case law. of an employee while that employee is
workplace mitigates that grave danger. The notification requirement in infectious. The requirement in
This is true even for fully vaccinated paragraph (h)(1) is an important paragraph (h)(2) to temporarily remove
employees since they also have the measure to ensure employers can take a COVID–19 positive employee from the
potential to transmit COVID–19 to other adequate steps to protect their workplace does not mean permanent
individuals, including other employees. employees from the hazard of COVID– removal of an employee from their
Because the goal of this ETS, and the 19 because it is connected to a parallel position. Any time an employee is
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61535
required to be removed from the The employee may also return to workplace. Similarly, employers may
workplace under paragraph (h)(2) of this work if they meet the return to work consider removing employees from the
section, the employer can require the criteria in CDC’s ‘‘Isolation Guidance’’ workplace if the employer learns that
employee to work remotely or in (incorporated by reference, § 1910.509) the employee was notified by a state or
isolation if suitable work is available (CDC, February 18, 2021) as described local public health authority to
and if the employee is not too ill to in paragraph (h)(2)(ii). CDC’s guidance quarantine or isolate; the employer
work. In cases where working remotely states that a COVID–19 positive person might even be contacted by such an
or in isolation is not possible, OSHA can stop isolating when three criteria authority directly. Although this ETS
encourages employers to consider are met: (1) At least ten days have does not require removal from the
flexible and creative solutions, such as passed since the first appearance of the workplace in those situations, the
a temporary reassignment to a different person’s symptoms; (2) the person has employer might choose to remove
position that can be performed by gone at least 24 hours without a fever employees from the workplace, above
telework. However, if an employee is (without the use of fever-reducing and beyond what is required by this
too ill to work, remote work should not medication); and (3) the person’s other ETS.
be required, and sick leave or other symptoms of COVID–19 are improving Finally, the note to paragraph (h)(2)
leave should be made available as (excluding loss of taste and smell). If a clarifies that this ETS does not require
consistent with the employer’s general person has tested positive but never employers to provide paid time to any
policies and practices, and as may be experiences symptoms, then the person employee for removal as a result of a
required under applicable laws. can stop isolating after ten days from the positive COVID–19 test or diagnosis of
After an employee has been removed date of their positive test. These COVID–19; however, paid time may be
from the workplace as required by recommendations are based on required by other laws, regulations, or
paragraph (h)(2), the employer must scientific evidence reviewed by CDC, collective bargaining agreements or
ensure that they do not return to the which indicates that levels of viral RNA other collectively negotiated
workplace until the employee meets one in upper respiratory tract samples begin agreements. On the other hand, the ETS
of three criteria outlined in paragraphs decreasing after the onset of symptoms does not preclude employers from
(h)(2)(i) through (h)(2)(iii). The purpose (CDC, September 14, 2021). The choosing to pay employees for time
of these provisions is to ensure that an rationale for including CDC’s ‘‘Isolation required for removal under this
employee who has COVID–19 does not Guidance’’ in the ETS was addressed in standard. Additionally, employers
return to work until the risk that they detail in Need for Specific Provisions in should allow their employees to make
will transmit the disease to others in the the agency’s prior rulemaking on use of any accrued leave in accordance
workplace has been minimized. Each of 1910.502 (see 86 FR 32376, 32455). with the employer’s policies and
these provisions is based on the best Finally, the employee may return to practices on use of leave. This
scientific evidence available on when a work, per paragraph (h)(2)(iii), if the provision, while not placing the burden
person with COVID–19 is no longer employee receives a return-to-work on the employer to provide paid time,
likely to transmit the virus. recommendation from a licensed should not be read as depriving
Under paragraph (h)(2)(i), the healthcare provider. The appropriate employees of the benefits they are
employee can return to work if they duration of removal from work for any normally entitled to as part of their
receive a negative result on a COVID–19 given individual may differ depending employment.
nucleic acid amplification test (NAAT) on factors such as disease severity or the Because it does not require employers
following a positive result on a COVID– health of the employee’s immune to provide paid time to employees who
19 antigen test (the most common system. For this reason, the ETS permits are removed for a positive COVID–19
screening test). There is a small employers to make decisions about an test or diagnosis of COVID–19, this ETS
possibility for employees to receive false employee’s return to work in differs from OSHA’s COVID–19
positive test results when conducting accordance with guidance from a Healthcare ETS, which applies to
regular screening with an antigen test. licensed healthcare provider (who employees in the healthcare industry
Positive results are usually highly would be better acquainted with a who are expected to be exposed to
accurate at moderate-to-high peak viral particular employee’s condition). If a COVID–19, and requires paid medical
load, but false positives can occur, licensed healthcare provider removal protection benefits
depending on the course of infection recommends a longer period of isolation (§ 1910.502(l)(5)) for most employees.
(FDA, April 2021). OSHA recognizes for a particular employee than the CDC’s This difference reflects the structure and
that an employee might choose to seek ‘‘Isolation Guidance’’ would otherwise focus of this ETS relative to the
a NAAT test for confirmatory testing. recommend, then the employer would Healthcare ETS. The Healthcare ETS
NAATs are considered the ‘‘gold need to abide by that longer period requires employees to report symptoms
standard’’ for clinical diagnosis of rather than returning the employee to of COVID–19 to their employers, as well
SARS–CoV–2 and may have a higher work after ten days. as positive COVID–19 tests or diagnoses
sensitivity (i.e., ability to correctly OSHA’s removal requirements as (see § 1910.502(l)(2)), but does not
generate a positive result) than antigen outlined in paragraph (h)(2) are require employees to be regularly tested
tests (CDC, September 9, 2021). If an intended to set the floor for what is for COVID–19. A primary function of
employee tested positive for COVID–19 required; however, OSHA encourages the payment for medical removal in that
via an antigen test, but then received employers who are able to do so to have standard is, therefore, to remove the
follow-up confirmatory testing via a a more robust program of medical potential for financial disincentives that
NAAT and the NAAT was negative, the removal, as indeed some employers might deter employees from reporting
positive antigen test can be considered have already done. In addition to any signs or symptoms of COVID–19
a false positive and the employee can removal from the workplace based on a that they experience. Because this ETS
return to work (CDC, September 9, positive COVID–19 test or diagnosis of already requires testing for
2021). For a more detailed discussion of COVID–19, employers may consider unvaccinated workers, which should
COVID–19 tests, see the Summary and removal based on COVID–19 symptoms result in employers learning of cases of
Explanation for paragraph (c) (Section or certain exposure or close contacts COVID–19 in unvaccinated workers,
VI.C. of this preamble). employees have had outside of the and does not otherwise require
App. 135
61536 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
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symptoms of COVID–19 to their doi:10.1038/s41467–020–20742–8.
Centers for Disease Control and Prevention PMID: 33414470; PMCID: PMC7788536.
employers, OSHA found that requiring (CDC). (2021, February 18). Isolate if you (Wells et al., 2021)
employer payment for removal was not are sick. https://www.cdc.gov/
necessary in this standard. coronavirus/2019-ncov/if-you-are-sick/ I. Face Coverings
As the note to paragraph (h) indicates, isolation.html. (CDC, February 18, 2021).
Centers for Disease Control and Prevention
Paragraph (i) of this standard
the employer may be required to follow addresses the use of face coverings. As
(CDC). (2021, June 30). Interim Guidance
other laws or regulations that would previously discussed in Grave Danger
for Use of Pooling Procedures in SARS-
require paid medical removal. For CoV–2 Diagnostic and Screening Testing. (Section III.A. of this preamble),
example, if an employee covered by this https://www.cdc.gov/coronavirus/2019- COVID–19 spreads when an infected
ETS believes they were exposed to ncov/lab/pooling-procedures.html. (CDC, person breathes out droplets and very
COVID–19 in the workplace and then June 30, 2021) small particles that contain the virus.
tested positive, that employee may be Centers for Disease Control and Prevention These droplets and particles can be
entitled to workers’ compensation (CDC). (2021, September 9). Interim
Guidance for Antigen Testing for SARS-
breathed in by other people or land on
benefits. Workers’ compensation is a their eyes, noses, or mouth. Face
CoV–2. https://www.cdc.gov/
system already in place to provide coverings reduce the risk of droplet
coronavirus/2019-ncov/lab/resources/
benefits to employees who get sick or antigen-tests-guidelines.html. (CDC, transmission of COVID–19. The CDC
injured on the job from occupational September 9, 2021). recommends that people who are not
disease or a work-related injury. Some Centers for Disease Control and Prevention fully vaccinated wear a face covering
states have expressly clarified or (CDC). (2021, September 14). Ending (e.g., a mask) in indoor public places.
expanded their workers compensation Isolation and Precautions for People with (CDC, July 14, 2021). Additional
rules to allow for COVID–19 claims COVID–19: Interim Guidance. https://
www.cdc.gov/coronavirus/2019-ncov/
discussion on the efficacy of face
during the pandemic (see, e.g., coverings is provided below.
hcp/duration-isolation.html. (CDC,
Industrial Commission of Arizona, May Face coverings are simple bi-
September 14, 2021).
15, 2020; Connecticut Executive Order Connecticut Executive Order No. 7JJJ. (2020, directional barriers that tend to keep
No. 7JJJ, July 24, 2020; Minn. Stat. Ann. July 24). Executive Order No. 7JJJ droplets, and to a lesser extent airborne
§ 176.011 Subd. (15)(f), 2020)). Protection of public health and safety particulates, on the side of the filter
Finally, the ETS does not contain during COVID–19 pandemic and from which they originate. An
specific requirements under this response—rebuttable presumption explanation of the term ‘‘face covering’’,
paragraph for the employer to establish regarding workers compensation benefits as used in this ETS, can be found in the
or maintain records of employee related to contraction of COVID–19.
https://portal.ct.gov/-/media/Office-of-
Summary and Explanation for
notifications of a positive COVID–19 the-Governor/Executive-Orders/Lamont- paragraph (c) (Section VI.C. of this
test or diagnosis of COVID–19 by a Executive-Orders/Executive-Order-No- preamble). The CDC (August 13, 2021)
licensed healthcare provider. However, 7JJJ.pdf. (Connecticut Executive Order recommends unvaccinated people wear
should an employer determine that a No. 7JJJ, July 24, 2020). face coverings when indoors to prevent
reported case of COVID–19 is work- Food and Drug Administration (FDA). (2021, getting and spreading COVID–19 mostly
related, the employer must continue to April). Coronavirus Disease 2019 Testing by blocking large respiratory droplets
record that information on the OSHA Basics. https://www.fda.gov/media/ from either leaving the face covering of
Forms 300, 300A, and 301, or on 140161/download. (FDA, April 2021).
Industrial Commission of Arizona. (2020,
the wearer (source control) or by
equivalent forms, if required to do so May 15). COVID–19 Workers’ preventing someone else’s droplets from
under 29 CFR part 1904. This also Compensation Claims. https:// reaching the wearer (personal
includes confirmed cases of COVID–19 www.azica.gov/sites/default/files/ protection). The need for face coverings
identified under paragraph (h) that an SPS%20-COVID-19%20FINAL.pdf. in workplaces applies particularly to
employer determines are work-related. (Industrial Commission of Arizona, May unvaccinated workers due to their
Under 29 CFR part 1904, COVID–19 is 15, 2020). increased potential for asymptomatic
a recordable illness and employers are Kucharski AJ et al. (2020). Effectiveness of and pre-symptomatic transmission of
responsible for recording cases of isolation, testing, contact tracing, and
physical distancing on reducing
COVID–19.
COVID–19 if: (1) The case is a transmission of SARS–CoV–2 in
The CDC Healthcare Infection Control
confirmed case of COVID–19 as defined different settings: a mathematical Practices Advisory Committee’s
by the Centers for Disease Control and modelling study. The Lancet Infectious (HICPAC) ‘‘Isolation Guidance’’ for
Prevention (CDC); (2) the case is work- Disease. 2020 Oct; 20(10): 1151–1160. healthcare settings has long
related as defined by 29 CFR part doi:10.1016/S1473–3099(20)30457–6. recommended facemasks, among other
1904.5; and (3) the case involves one or Epub 2020 Jun 16. PMID: 32559451; controls, to prevent the transmission of
more of the general recording criteria in PMCID: PMC7511527. (Kucharski et al., viruses that cause respiratory illnesses
set forth in 29 CFR part 1904.7 (e.g., 2020) (Siegel et al., 2007). Face coverings play
Minnesota Statutes Annotated, Section
medical treatment beyond first aid, days 176.011 Definitions. Subd. 15(f). (2020).
an important dual role in protecting
away from work). Under 29 CFR part https://www.revisor.mn.gov/statutes/ workers from droplet transmission of
1904, employers must generally provide cite/176.011/pdf. (Minn. Stat. Ann. COVID–19. One of their key purposes is
access to the 300 log to employees, § 176.011 Subd. (15)(f), 2020) to function as source control. In this
former employees, and their Moghadas S et al. (2020, July 6). The role, the face covering helps protect
representatives with the names of implications of silent transmission for people around the wearer by reducing
injured or ill employees included on the the control of COVID–19 outbreaks. the number of infectious droplets
form. If, however, the employee requests Proceedings of the National Academy of released into the air by the wearer and
Sciences of the United States of America,
that their name not be entered on the 117(30), 17513–17515. doi:https://
limiting the distance traveled by any
300 log, the employer must treat their doi.org/10.1073/pnas.2008373117. particles that are released. As a result,
illness as a privacy concern case and (Moghadas et al., July 6, 2020) anyone near the wearer is exposed to
may not enter their name on the log (see Wells CR et al. (2021). Optimal COVID–19 fewer (if any) droplets and the
29 CFR 1904.29(b)(6), (b)(7)(vi)). quarantine and testing strategies. Nature transmission risk is lowered (OSHA,
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61537
January 28, 2021; Siegel et al., 2007). wearer will be at reduced risk of, and indoor settings and in outdoor settings
Face coverings also provide a degree of could be protected from, infection. where physical distancing cannot be
particulate filtration to reduce the Accordingly, over the course of the maintained (WHO, December 1, 2020).
amount of inhaled particulate matter, pandemic, through its guidance, OSHA In the United States, several states
meaning face coverings can help protect has strongly encouraged workers to have imposed statewide face covering
the wearer themselves, by reducing their wear face coverings when they are in mandates in order to mitigate the spread
inhalation of droplets produced by an close contact with others to reduce the of COVID–19. One study examined data
infected person nearby (CDC, May 7, risk of spreading COVID–19 despite the on statewide face covering mandates
2021; Brooks et al., February 10, 2021). shortcomings that have prevented the during March 1–October 22, 2020, and
The efficacy of any given face agency from considering them to be PPE found that statewide face covering
covering in either functioning as source that complies with the requirement of mandates were associated with a
control or protecting the wearer will the PPE standard. To enhance the decline in weekly COVID–19–associated
depend on the construction, design, and effectiveness of any face covering hospitalization growth rates by up to 5.6
material used for the face covering. The required by this standard, this ETS percentage points for adults aged 18–64
CDC has stated that ‘‘masks are imposes certain minimum design years after mandate implementation,
primarily intended to reduce the criteria, consistent with CDC compared with growth rates during the
emission of virus-laden droplets recommendations. Thus, the face 4 weeks preceding implementation of
(‘‘source control’’), which is especially covering must consist of at least two the mandate (Joo et al., February 12,
relevant for asymptomatic or layers of material that is either tightly 2021). Similarly, another study
presymptomatic infected wearers who woven or non-woven, and the face examined the association of state-issued
feel well and may be unaware of their covering must not have visible holes or face covering mandates with COVID–19
infectiousness to others, and who are openings. CDC has found face coverings cases and deaths during March 1–
estimated to account for more than 50% that are tightly woven and made with at December 31, 2020, and found
of transmissions’’ (CDC, May 7, 2021). least two layers are more effective at mandating face coverings was
The CDC has also stated that: ‘‘Multi- filtering droplets than face coverings associated with a decrease in daily
layer cloth masks block release of that are loosely woven or consist of a COVID–19 case and death growth rates
exhaled respiratory particles into the single layer of fabric (CDC, May 7, 2021; within 20 days of implementation (Guy
environment, along with the Ueki et al., June 25, 2020). et al., March 12, 2021).
microorganisms these particles carry. School face covering policies for
Cloth masks not only effectively block OSHA’s determination on the students, staff members, faculty, and
most large droplets (i.e., 20–30 microns importance of face coverings is visitors are associated with a reduction
and larger) but they can also block the supported by a substantial body of in COVID–19 outbreaks. Between July
exhalation of fine droplets and particles evidence. As described in further detail 15 and August 31, 2021, schools in
(also often referred to as aerosols) below, consistent and correct use of face Arizona were analyzed for school mask
smaller than 10 microns; which increase coverings is widely recognized and policies, which provided that all
in number with the volume of speech scientifically supported as an important persons, regardless of vaccination
and specific types of phonation. Multi- evidence-based strategy for COVID–19 status, were required to wear a mask
layer cloth masks can both block up to control. Accordingly, with specific indoors. The odds of a school-associated
50–70% of these fine droplets and exceptions relevant to outdoor areas and COVID–19 outbreak in schools without
particles and limit the forward spread of vaccinated persons, the CDC a mask requirement were 3.5 times
those that are not captured. Upwards of recommends everyone two years of age higher than those in schools with an
80% blockage has been achieved in and older wear a face covering in public early mask requirement (Odds Ratio =
human experiments that have measured settings and when around people 3.5; 95% Confidence Interval = 1.8–6.9)
blocking of all respiratory droplets, with outside of their household (CDC, August (Jehn et al., October 1, 2021).
cloth masks in some studies performing 13, 2021). And, on January 21, 2021, The effectiveness of face coverings in
on par with surgical masks as barriers President Biden issued Executive Order limiting the emission and spread of
for source control’’ (CDC, May 7, 2021). 13998, which recognizes the use of face droplets has also been demonstrated in
Thus, the construction of the face coverings or facemasks as a necessary, numerous studies. For example,
covering is a significant factor in science-based public health measure to multiple studies in which droplets were
determining its efficacy at reducing prevent the spread of COVID–19, and visualized while individuals were
COVID–19 transmission. therefore directed regulatory action to talking or a manikin was used to
While face coverings are generally require that they be worn in compliance simulate coughs and sneezes
effective as source control, because of with CDC guidance while traveling on demonstrated that two-layer face
the potential variations in protective public transportation (e.g., buses, trains, coverings limited the number of
properties, OSHA has not considered subway) and while at airports droplets released into the air, and
face coverings that are not certified to a (Executive Order 13998, 86 FR 7205, limited the forward spread of those not
consensus standard to be personal 7205 (Jan. 21, 2021); CDC, February 2, captured (Fischer et al., September 2,
protective equipment (PPE) under 2021). Similarly, the World Health 2020; Verma et al., June 30, 2020; CDC,
OSHA’s general PPE standard (29 CFR Organization (WHO) has recognized face May 7, 2021).
1910.132), as there is insufficient coverings as a key measure in The effectiveness of face coverings in
assurance that any given face covering suppressing COVID–19 transmission, preventing infections was also observed
is of safe design and construction for the and thus, saving lives. The WHO in a number of epidemiological studies.
work to be performed, which is required observes that face coverings serve two For example, in June of 2020 an
by the PPE standard. Despite these purposes, to both protect healthy people outbreak was studied aboard the USS
limitations, many of the available face from acquiring COVID–19 and to Theodore Roosevelt, an environment
coverings have proven to be effective at prevent sick people from further notable for congregate living quarters,
providing source control, and where a spreading it. Since December of 2020, close working environments, and a
face covering is also effective in the WHO has recommended that the sample of mostly young, healthy adults.
providing personal protection, the general public wear face coverings in The investigation found that use of face
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61538 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
coverings on board was associated with (Chernozhukov et al., September 15, individuals wear a cotton face covering,
a 70% reduced risk of transmission, 2020) nationally. Each community the exposure is reduced 67%. If both are
which demonstrates that the use of face analysis demonstrated that, following wearing facemasks, exposure is reduced
coverings, especially among universal face covering directives from by 76%. When an infected individual
asymptomatic cases, can help mitigate both organizational and political wore an N95 respirator, exposure was
future transmission (Payne et al., June leadership, new infections were shown reduced by 96% or, when the seams
12, 2020). Another publication, released to fall significantly. These analyses have were taped, 99.7%.
in July of 2020, included an also shown reductions in mortality and As demonstrated by the studies above,
investigation of a high-exposure event the need for lockdowns, with their proper face covering usage leads to a
among 139 clients exposed to two associated monetary/gross domestic substantial reduction in the emission of
symptomatic hair stylists with product losses (Leffler et al., December virus-containing droplets and
confirmed cases of COVID–19. Both of 2, 2020; Hatzius et al., June 29, 2020). consequent transmission of the virus.
the stylists and all of their clients wore Additionally, multiple investigations This is especially critical for
face coverings during their interactions. involving infected passengers aboard asymptomatic or pre-symptomatic
Among 67 clients subsequently tested flights longer than ten hours strongly infected wearers who feel well and may
for COVID–19, all test results were suggest that face covering usage not be taking other preventative
negative; no symptomatic secondary prevented in-flight transmissions, as measures—like self-isolation—because
cases were reported by any clients, demonstrated by the absence of they are unaware of their infectiousness
including those who were not tested. infection developing in other passengers to others. Combined, these individuals
The study concluded that the strict use and crew in the 14 days following are estimated to account for more than
of face coverings likely mitigated the exposure (Schwartz et al., April 14, 50% of COVID–19 transmissions
spread of COVID–19 (Hendrix et al., 2020; Freedman and Wilder-Smith, (Honein et al., December 11, 2020;
July 17, 2020). September 25, 2020). Moghadas et al., July 6, 2020; Johansson
Several other observational Researchers from the COVID–19 et al., January 7, 2021). This figure could
epidemiological studies have reviewed Systematic Urgent Review Group Effort be substantially reduced if face
data regarding the ‘‘real-world’’ investigated the effects of face coverings coverings are required, even for
effectiveness of face covering usage. and eye protection on virus individuals who do not feel sick. Face
First, in a study of 124 Beijing transmission in both healthcare and covering use is also especially important
households with one or more non-healthcare settings. They identified in indoor spaces (Honein et al.,
laboratory-confirmed case of COVID–19, 172 observational studies for their December 11, 2020). The studies
face covering use by both the index systematic review and 44 comparative reviewed above show that face
patient and all family contacts before studies for their meta-analysis, coverings reduce the release of droplets
the index patient developed symptoms including data on 25,697 COVID–19, but do not completely eliminate them.
reduced secondary transmission (i.e., SARS, or MERS patients. They CDC guidance affirms that COVID–19
infections occurring within two weeks concluded for the general public, based pandemic control requires face covering
of symptom onset in the index case) mainly on evidence from face covering use (Honein et al., December 11, 2020;
within the households by 79% (Wang et use within households and among CDC, May 7, 2021). Similarly, the WHO
al., May 11, 2020). Second, a contacts of cases, that disposable advises face covering use as a critical
retrospective case-control study from surgical masks or face coverings measure of a comprehensive package of
Thailand documented that, among more (reusable multi-layer cotton face prevention and control measures to
than 1,000 persons interviewed as part coverings) are associated with limit the spread of COVID–19 (WHO,
of contact tracing investigations, those protection from viral transmission. December 1, 2020).
who reported having always worn a face Through the meta-analysis, combining Although increasing COVID–19
covering during high-risk exposures 39 of the studies’ results, they found a vaccination coverage remains the most
experienced a greater than 70% reduced 14.3% reduction in the difference of effective means to achieve control of the
risk of infection compared with persons anticipated absolute effect (e.g., the pandemic, additional layered
who did not wear face coverings under chance of viral infection or prevention strategies will be needed in
these circumstances. The risk for transmission) between no face covering the short term to minimize preventable
infection was not significantly lower in and face covering groups (Chu et al., morbidity and mortality among
those who reported only sometimes June 27, 2020). unvaccinated individuals. Unvaccinated
wearing face coverings compared to Ueki et al. (June 25, 2020) evaluated individuals remain at substantial risk
those who did not wear face coverings the effectiveness of cotton face for infection, severe illness, and death,
at all. This evidence supports the coverings, facemasks, and N95s (a especially in areas where the level of
conclusion that face coverings must be commonly used respirator) in SARS–CoV–2 community transmission
worn consistently and correctly to preventing transmission of SARS–CoV– is high (discussed in detail in Grave
meaningfully reduce the risk of 2 using a laboratory experimental Danger (Section III.A. of this preamble)).
infection (Doung-ngern et al., September setting with manikins. The researchers Among strategies to prevent COVID–19,
14, 2020). found that all offerings provided some CDC recommends all unvaccinated
Community-level analyses have also measure of protection as source control, individuals wear face coverings in
confirmed the benefit of universal face limiting droplets expelled from both public indoor settings. A proven
covering use in: A unified hospital infected and uninfected wearers. For effective strategy against SARS–CoV–2
system (Wang et al., July 14, 2020); a instance, when spaced roughly 20 transmission, beyond vaccination,
German city (Mitze et al., June 1, 2020); inches apart, an uninfected person can includes using face coverings
a U.S. state (Gallaway et al., October 6, reduce inhalation of infectious virus by consistently and correctly (Christie et
2020); a panel of 15 U.S. states and 37% by wearing a cotton face covering. al., July 30, 2021).
Washington, DC (Lyu and Wehby, June If only the infected person wears a The agency is not requiring the use of
16, 2020; Hatzius et al., June 29, 2020); cotton face covering, the amount face coverings by workers who are fully
as well as both Canada (Karaivanov et breathed in by the uninfected recipient vaccinated because vaccination is
al., October 1, 2020) and the U.S. is reduced by 57%. However, if both sufficient to reduce the grave danger to
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61539
themselves or others. While vaccination Bloodborne Pathogens standard (29 CFR completely covers the nose and mouth
is sufficient to reduce grave danger to 1910.1030). Facemasks are intended for of the wearer, excluding face shields,
the workers themselves, the agency a medical purpose, such as prevention which is made with two or more layers
recognizes that there may still be of infectious disease transmission of a breathable fabric that is tightly
residual risk (e.g., breakthrough (including uses related to COVID–19). woven, is secured to the wearer’s head
infections); severe health outcomes Facemasks can function as a barrier to with ties, ear loops, or elastic bands that
among vaccinated workers, however, are protect the wearer from hazards such as go behind the head, and is a solid piece
unlikely. Vaccination is also sufficient splashes or large droplets of blood and of material without slits, exhalation
to reduce the grave danger that fully bodily fluids. Facemasks, such as valves, visible holes, or other openings
vaccinated workers present to others surgical masks, must be FDA-cleared or in the material. This definition
given the reduced likelihood of authorized by FDA, including under an encompasses face coverings that
transmission (see Grave Danger in EUA and provide a similar or greater otherwise meet the definition of face
Section III.A. of this preamble). level of protection when serving the covering under paragraph (c), but
Nonetheless, the use of face coverings purposes of a face covering. Respirators include clear plastic windows, such as
by fully vaccinated workers, while not are another type of personal protective those utilized by persons
required by this ETS, is strongly device that OSHA has regulated under communicating with those who are deaf
encouraged in a wide range of the Respiratory Protection standard (29 or hard-of-hearing or when seeing a
circumstances to reduce the overall risk CFR 1910.134). person’s mouth is otherwise important.
of transmitting COVID–19, particularly The best available experimental and Face coverings can be manufactured or
in areas of substantial or high epidemiological data support consistent homemade, and they can incorporate a
transmission, when indoors and when use of face coverings by unvaccinated variety of designs, structures, and
in crowded outdoor areas. The use of workers in work settings to reduce the materials. Face coverings can be
face coverings by customers and visitors spread of COVID–19 through droplet disposable or reusable. Face coverings
to workplaces is also beneficial in transmission. As discussed in Need for do not have to meet a consensus
reducing the overall risk of workplace the ETS (Section III.B. of this preamble), standard, although they might. Apart
transmission of COVID–19. adopting face covering policies is from any applicable FDA or NIOSH
OSHA has always considered necessary, as part of a strategy combined regulatory requirements that might
recognized consensus standards, with with testing, to protect employees from otherwise apply, such requirements are
design and construction specifications, exposure to COVID–19. Requiring not required solely for the purposes of
when determining the PPE requirements unvaccinated workers to wear face meeting the requirements of this
of the agency’s standards. The OSH Act coverings in the workplace will reduce standard.
(29 U.S.C. 655(b)(8)) requires the agency the likelihood that, in conjunction with
to generally give deference to consensus the testing (paragraph (g)) and removal, As a general rule, OSHA has authority
standards unless setting its own of infected workers, (paragraph (h)) to, and does, require employers to bear
specifications would better effectuate requirements, they will spread the virus the costs for protective equipment,
the purposes of the Act. The agency’s to others, including other unvaccinated among other worker protections,
standards generally require PPE to coworkers. Based on the proven required by an OSHA standard. See,
conform to the specifications in effectiveness of face covering use, e.g., 29 CFR 1910.1018(j) (requiring the
consensus standards through OSHA’s COVID–19 ETS includes employer to provide protective clothing
incorporation by reference (e.g., eye and necessary provisions for required use of at no cost to the employee). However, in
face protection, head protection, foot face coverings by unvaccinated workers limited circumstances, OSHA has
protection). ASTM released a and provisions to allow vaccinated chosen not to require employers to pay
specification standard on February 15, workers and customers and visitors to for some forms of non-specialized
2021, to establish a national standard wear face coverings or respirators as a protective equipment, such as every-day
baseline for barrier face coverings component of reducing the overall risk clothing, products providing weather-
(ASTM F3502–21). OSHA considered, of COVID–19 transmission in the related protection, and non-specialized
as required, incorporation of ASTM workplace. equipment that the employee wears off
F3502–21 in this ETS. However, the The benefits that result from the use the job site. See 29 CFR 1910.132(h)(2)–
agency has determined that it is of face coverings for preventing (5). Like the analogous situations listed
infeasible for the timeframe of this ETS transmission of COVID–19 are derived above, here employees may use their
to incorporate this consensus standard from the combination of source control personal face coverings in a variety of
or to otherwise establish additional (i.e., reducing the spread of large circumstances on and off the job site as
criteria for face coverings beyond that respiratory droplets to others by part of their every-day protection.
already recommended by the CDC due covering an infected person’s mouth Because the types of face coverings
to the time needed to manufacture and and nose) and some personal protection permitted under this ETS are widely
distribute any new product. OSHA for the wearer, as was discussed above used and readily available, (see
notes the CDC’s guidance on types of in the Need for Face Coverings section. Technological Feasibility (Section IV.A.
masks, including those that meet ASTM Face coverings are a vital layer of of this preamble)), employees will have
F3502–21 requirements, and respirators protection, and the benefit to any given no difficulty obtaining them. OSHA is
as helpful to employers and workers in individual increases with increasing requiring employers to bear the costs for
selecting an appropriate product (CDC, community use. Paragraph (i) contains employee vaccination, because it is the
September 23, 2021). requirements for the use of face more protective control, (Need for the
Relatedly, OSHA has previously coverings by each employee who is not ETS (Section III.B. of this preamble).
established that medical facemasks are fully vaccinated, as well as alternatives OSHA does not believe it appropriate to
essential PPE for workers in healthcare to face coverings (e.g., facemasks, impose the costs of personal face
and associated industries, and are respirators) that may be acceptable in coverings on an employer where an
already used by workers under both the some situations (described in detail employee has made an individual
general PPE standard (29 CFR below). As defined in paragraph (c), a choice to pursue a less protective
1910.132), and more specifically, the face covering means a covering that option. For these reasons, OSHA has
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61540 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
determined not to impose the costs of related to their job duties, or their job coverings more frequently (e.g., in food,
face coverings on the employer as a requires the use of their uncovered meat, or poultry processing plants;
requirement under this ETS. mouth, or when the use of a face water, sanitation, or wastewater
Paragraph (i)(1) requires employers to covering presents a risk of serious injury treatment facilities; or restaurants). As
ensure that each employee who is not or death to the employee, would also be note 1 to paragraph (i) addresses, face
fully vaccinated wears a face covering covered under this provision. As has shields may be worn in addition to face
when indoors or when occupying a been previously discussed in Summary coverings to prevent them from getting
vehicle with another person for work and Explanation for paragraph (d) wet and soiled. For work where face
purposes, except (i) when an employee (Section VI.D. of this preamble), OSHA coverings are expected to become dirty
is alone in a room with floor to ceilings recognizes that there may be certain or soiled less frequently, employees may
windows and a closed door. However, if workers who may not be able to wear a only need to replace their face coverings
that employee exits the room or another face covering due to a disability or daily (e.g., in retail or office buildings).
individual enters the room, they are sincerely held religious belief and are Regardless of work location, reusable
required to wear a face covering. The entitled to an accommodation. face coverings can become soiled after
second exception is (ii) for a limited If employers receive accommodation each use and may be contaminated with
time while an employee is eating or requests relating to face coverings or bacteria and viruses, including the virus
drinking at the workplace or for other protective gear, for example due to that causes COVID–19. To ensure
identification purposes in compliance disability or religious garb or grooming, performance and minimize the risk of
with safety and security requirements. they should evaluate those requests contaminating employees after contact
Under this exception, employees are not under applicable laws (EEOC, October with a soiled face covering, as described
required to wear face coverings during 25, 2021). previously, the CDC recommends
the limited time while eating or Paragraph (i)(2) requires that washing them whenever they get dirty,
drinking at the workplace. Employers employers ensure that any face covering but at least once a day. The CDC also
may also let employees eat or drink required to be worn by this section is: has guidance on the selection, proper
outside where there may be more space (i) Worn by the employee to fully cover wearing, cleaning, and storage of face
and reduced risk of transmission. the employee’s nose and mouth; and (ii) coverings (CDC, August 13, 2021).
Additionally, under the exception in replaced when wet, soiled, or damaged The employer must not prevent any
paragraph (i)(1)(ii), employees are not (e.g., is ripped, has holes, or has broken employee, regardless of vaccination
required to wear a face covering for a ear loops). To be worn properly, face status, from voluntarily wearing a face
limited time for identification purposes coverings must completely cover the covering or facemask unless the
in compliance with safety and security wearer’s mouth and nose and must fit employer can demonstrate that doing so
requirements. This means that an snugly against the sides of the face would create a hazard (paragraph (i)(3)).
unvaccinated employee can temporarily without gaps. Gaps can let air with While vaccination greatly reduces the
remove their face covering when at a respiratory droplets leak in and out risk of the most severe consequences of
security checkpoint within their around the edges of the mask. Face COVID–19 (e.g. hospitalizations and
worksite and when identification is coverings with a nose wire help to avoid fatalities) to workers, it does not reduce
otherwise required. issues with glasses fogging and create a the risk to zero and thus workers must
Another exception for required face snug fit. Workers can also use a mask be permitted to wear face coverings or
coverings is under paragraph (i)(1)(iii) fitter or brace over a disposable mask or facemasks even when not required to in
for when an employee is wearing a a cloth mask to prevent air from leaking order to allow the workers to further
respirator or facemask in accordance around the edges of the mask. To ensure address residual risk. The agency has
with other OSHA standards (e.g., face coverings are worn properly, an determined this provision is necessary
1910.134, 1910.504, 1910.1030, employer might appoint a manager or because employees may themselves
1910.502). Facemask or respirator use in senior employee to check that each have additional medical risk factors that
accordance with other OSHA standards unvaccinated employee is properly employers may or may not be aware of,
takes precedence over face covering use wearing a face covering at the start of and which require enhanced
in this ETS. For example, OSHA and throughout each shift. Many aspects precautions. Similarly, employees may
standard 1910.1030 has requirements of proper mask use are easily observable live with or have frequent contact with
for facemasks in healthcare settings and (e.g., covering the mouth and nose, as family members or others who have
requires that workers should continue to well as no observable gaps). enhanced risk if infected with COVID–
use the required facemask appropriate Additionally, employers may consider 19 and thus justify assuring the
for that setting. Another example may utilizing workplace announcements employees’ ability to take reasonable
include a worker who is required to use (email messages, safety talks, etc.) or precautions to protect their own health
a respirator under 1910.134 for displaying signs or posters throughout and safety or that of loved ones.
workplace exposure to harmful dusts, the facility about proper face covering Paragraph (i)(4) states that the
where effective engineering controls are usage. employer must permit the employee to
not feasible; that worker should The employer must ensure that wear a respirator instead of a face
continue to use the required respirator. employees replace face coverings when covering whether required or not (i.e.,
Employees must resume wearing a face wet, soiled, or damaged (paragraph without regard to vaccination status),
covering when not engaged in the (i)(2)(ii)). Face coverings can become and the employer may provide
activity where a facemask or respirator soiled by splashes, sprays, or splatters, respirators to the employee, even if not
is required as an essential part of their from contact with a contaminated required. This means that when a face
job. The last exception, contained in surface, or by touching/adjusting them covering is not required by paragraph
paragraph (i)(1)(iv), is for a very limited with contaminated hands. Damaged face (i)(1), the employer must permit the
set of circumstances where employers coverings may not fit properly and thus employee to wear a respirator or the
can show that the use of the face will have reduced effectiveness. employer may even provide a respirator;
covering is infeasible or creates a greater Employees who work where there is in such circumstances, the employer
hazard. Situations where it is important potential for spills, sprays, or splashes must also comply with 1910.504 (the
to see an employee’s mouth for reasons may need to change or replace their face mini respiratory protection program).
App. 140
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61541
Respirators, as defined in paragraph (c), higher filter efficiency and better sealing other collectively negotiated
are a type of PPE that are certified by characteristics of respirators when agreements.
NIOSH or authorized under an compared to face coverings. For
References
Emergency Use Authorization (EUA) by additional discussion, the rationale for
the FDA, and protect against airborne the mini respiratory protection program Brooks J et al. (2021, February 10).
hazards by removing specific air was addressed in detail in Need for Maximizing fit for cloth and medical
contaminants from the ambient Specific Provisions in the agency’s prior procedure masks to improve
(surrounding) air or by supplying rulemaking on 1910.504, and the performance and reduce SARS–CoV–2
transmission and exposure. MMWR. doi:
breathable air from a safe source. requirements of the mini respiratory http://dx.doi.org/10.15585/
Respirator use can provide an additional protection program section are mmwr.mm7007e1. (Brooks et al.,
level of comfort and protection beyond discussed in Summary and Explanation February 10, 2021)
that provided by face coverings for in the agency’s prior rulemaking on Centers for Disease Control and Prevention
employees in circumstances that do not 1910.504. (CDC). (2021, February 2). Order under
require a respirator to be used. As As required by paragraph (i)(5), the Section 361 of the Public Health Service
discussed previously, the agency has employers must not prohibit customers Act (42 U.S.C. 264) and 42 Code of
determined that workers need the or visitors from wearing face coverings. Federal Regulations 70.2, 71.31(b),
ability to wear PPE, even when it is not Face coverings are a vital layer of 71.32(b). Federal Register notice:
Wearing of face masks while on
required, in order to address residual protection against the risk of COVID–19.
conveyances and at transportation hubs.
risk and due to health conditions that (See the discussion earlier in this https://www.cdc.gov/quarantine/masks/
either they or their close contacts may section on the benefits to individuals mask-travel-guidance.html. (CDC,
have that warrant enhanced associated with increased community February 2, 2021)
precautions. For a more in-depth use.) This provision is necessary Centers for Disease Control and Prevention
description of the mini respiratory because increased use of face coverings (CDC). (2021, May 7). Scientific brief:
protection program, see the preamble to also reduces the overall risk of COVID– Community Use of Cloth Masks to
the Healthcare ETS (86 FR 32615– 19 transmission from the customers and Control the Spread of SARS–CoV–2.
visitors to workers, both unvaccinated https://www.cdc.gov/coronavirus/2019-
32617). OSHA intends the mini
ncov/more/masking-science-sars-
respirator protection program to be and vaccinated alike. Additionally, it
cov2.html. (CDC, May 7, 2021)
preserved for the duration of this ETS, allows customers and visitors to protect Centers for Disease Control and Prevention
and any references relied upon by their own health and safety. Employers (CDC). (2021, July 14). How COVID–19
OSHA in those sections of the may even want to create a policy spreads. https://www.cdc.gov/
Healthcare ETS are also incorporated encouraging the use of face coverings by coronavirus/2019-ncov/prevent-getting-
explicitly into the rulemaking docket for anyone who enters the business; they sick/how-covid-spreads.html. (CDC, July
this ETS. are encouraged to coordinate with state 14, 2021)
The mini respiratory protection and local health officials to obtain and Centers for Disease Control and Prevention
program is designed to strengthen respond appropriately to timely and (CDC). (2021, August 13). Your Guide to
Masks. https://www.cdc.gov/
employee protections with a small set of accurate information (e.g., level of coronavirus/2019-ncov/prevent-getting-
provisions for the safe use of respirators community transmission, health system sick/about-face-coverings.html. (CDC,
designed to be easier and faster to capacity, vaccination coverage, capacity August 13, 2021)
implement than the more for early detection of increases in Centers for Disease Control and Prevention
comprehensive respiratory protection COVID–19 cases, and populations at (CDC). (2021, September 23). Types of
program under 29 CFR 1910.134. This risk for severe outcomes from COVID– Masks and Respirators. https://
ETS is addressing an emergency health 19). Local conditions will influence the www.cdc.gov/coronavirus/2019-ncov/
crisis, so it is critical for employers to decisions that public health officials prevent-getting-sick/types-of-masks.html.
be able to get more employee protection make regarding community-level (CDC, September 23, 2021)
Chernozhukov V et al. (2020, September 15).
in place quickly. OSHA expects that this strategies. Additionally, workers and Causal impact of masks, policies,
approach will facilitate additional their representatives may also negotiate behavior on early COVID–19 pandemic
employee choice for the additional additional face covering measures not in the U.S. Journal of Econometrics. doi:
protection provided by respirators while required by the ETS through collective https://doi.org/10.1016/
reducing disincentives that may have bargaining agreements or other j.jeconom.2020.09.003. (Chernozhukov et
discouraged employers from allowing or collectively negotiated agreements. al., September 15, 2020)
voluntarily providing respirators. A Lastly, for the reasons explained Christie A et al. (2021, July 30). Guidance for
mini respirator program is therefore an above, note 2 to paragraph (i) clarifies implementing COVID–19 prevention
important control to protect employees that this section does not require the strategies in the context of varying
community transmission levels and
from the hazard posed by COVID–19. employer to pay for any costs associated
vaccination coverage. MMWR 70: 1044–
The mini respiratory protection with face coverings. However, the note 1047. http://dx.doi.org/10.15585/
program is primarily intended to be also makes clear that this section does mmwr.mm7030e2. (Christie et at., July
used for addressing circumstances not prohibit the employer from paying 30, 2021).
where employees are not exposed to for costs associated with face coverings Chu DK et al. (2020, June 27). Physical
suspected or confirmed sources of required by this section. OSHA notes Distancing, Face Masks, and Eye
COVID–19, but where respirator use that employer payment for face Protection to Prevent Person-to-Person
could offer enhanced protection to coverings may be required by other Transmission of SARS–CoV–2 and
employees. Examples include when a laws, regulations, or collective COVID–19: A systematic review and
respirator could offer enhanced bargaining agreements or other meta-analysis. The Lancet. 395: 1973–
1987. https://doi.org/10.1016/. (Chu et
protection in circumstances where a less collectively negotiated agreements. al., June 27, 2020)
protective (in terms of filtering and fit) Additionally, workers and their Doung-ngern P et al. (2020). Case-control
face covering is required under the ETS representatives may also negotiate study of use of personal protective
(See 29 CFR 1910.501(i)(1)). The employer payment for face coverings measures and risk for SARS–CoV–2
decision to use a respirator in place of not required by the ETS through infection, Thailand. Emerging Infectious
a face covering could be due to the collective bargaining agreements or Diseases, 26(11), 2607–2616. doi: https://
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dx.doi.org/10.3201/eid2611.203003. 10.1001/jamanetworkopen.2020.35057. Transmission of SARS–CoV–2. mSphere
(Doung-ngern et al., September 14, 2020). (Johansson et al., January 7, 2021) 5: e00637–20. https://doi.org/10.1128/
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Should Know About COVID–19 and the Hospitalization Growth Rates Associated Verma S et al. (2020, June 30). Visualizing
ADA, the Rehabilitation Act, and Other with Statewide Mask Mandates—10 the effectiveness of face masks in
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eeo-laws. (EEOC, October 25, 2021) mmwr.mm7006e2. (Joo et al., February June 30, 2020)
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filtering expelled particles during masks, public policies and slowing the care system and SARS–CoV–2 positivity
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Freedman D and Wilder-Smith A. (2020, w27891. (Karaivanov et al., October 1, jama.2020.12897. (Wang et al., July 14,
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SARS–CoV–2: A review of the attack Leffler C et al. (2020, December 2). Wang Y et al. (2020, May 11). Reduction of
rates and available data on the efficacy Association of country-wide Coronavirus secondary transmission of SAR–CoV–2
of face masks. Journal of Travel mortality with demographics, testing, in households by face mask use,
Medicine. doi: https://doi.org/10.1093/ lockdowns, and public wearing of masks. disinfection and social distancing: A
jtm/taaa178. (Freedman and Wilder- The American Journal of Tropical cohort study in Beijing, China. BMJ
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Gallaway S et al. (2020, October 6). Trends 2411. https://doi.org/10.4269/ajtmh.20– bmjgh–2020–002794. (Wang et al., May
in COVID–19 incidence after 1015. (Leffler et al., December 2, 2020) 11, 2020)
implementation of mitigation Lyu W and Wehby G. (2020, June 16). World Health Organization (WHO). (2020,
measures—Arizona, January 22–August Community use of face masks and December 1). Mask use in the context of
7, 2020. MMWR, 69, 1460–1463. doi: COVID–19: Evidence from a natural COVID–19. https://www.who.int/
http://dx.doi.org/10.15585/ experiment of state mandates in the U.S. emergencies/diseases/novel-coronavirus-
mmwr.mm6940e3. (Gallaway et al., Health Affairs, 39(8), 1419–1425. doi: 2019/advice-for-public/when-and-how-
October 6, 2020) 10.1377/hlthaff.2020.00818. (Lyu and to-use-masks. (WHO, December 1, 2020)
Guy GP Jr et al. (2021, March 12). Association Wehby, June 16, 2020)
of State-Issued Mask Mandates and Mitze T et al. (2020, June 1). Face masks
J. Information Provided to Employees
Allowing On-Premises Restaurant Dining considerably reduce COVID–19 cases in In order to successfully implement
with County-Level COVID–19 Case and Germany: A synthetic control method the provisions of the ETS, it is critical
Death Growth Rates—United States, approach. IZA—Institute of Labor that employers provide relevant
March 1–December 31, 2020. MMWR Economics (Germany). http://ftp.iza.org/ information to employees. Employers
Morb Mortal Wkly Rep 2021; 70: 350– dp13319.pdf. (Mitze et al., June 1, 2020) must provide employees with the
354. doi: http://dx.doi.org/10.15585/ Moghadas S et al. (2020, July 6). The
mmwr.mm7010e3. (Guy et al., March 12, implications of silent transmission for
information specified in paragraph (j),
2021) the control of COVID–19 outbreaks. an essential part of this ETS, because it
Hatzius J et al. (2020, June 29). Face masks Proceedings of the National Academy of helps to ensure that employees
and GDP. Goldman Sachs Research. Sciences of the United States of America, understand both their rights and
https://www.goldmansachs.com/ 117(30), 17513–17515. doi: https:// responsibilities under the ETS and their
insights/pages/face-masks-and-gdp.html. doi.org/10.1073/pnas.2008373117. employer’s policies and procedures. The
(Hatzius et al., June 29, 2020) (Moghadas et al., July 6, 2020) ETS cannot be effective if employees do
Hendrix J et al. (2020, July 17). Absence of Occupational Safety and Health not have sufficient knowledge and
apparent transmission of SARS–CoV–2 Administration (OSHA). (2021, January understanding of the requirements of
from two stylists after exposure at a hair 28). Frequently asked questions COVID–
salon with a universal face covering 19. https://www.osha.gov/coronavirus/
the ETS, their employers’ policies and
policy—Springfield, Missouri, May 2020. faqs. (OSHA, January 28, 2021) procedures, information about available
MMWR, 69, 930–932. doi: http:// Payne D et al. (2020, June 12). SARS–CoV– COVID–19 vaccines, their protections
dx.doi.org/10.15585/mmwr.mm6928e2. 2 infections and serologic responses from against retaliation and discrimination,
(Hendrix et al., July 17, 2020) a sample of U.S. Navy Service and the potential penalties for
Honein MA et al. (2020, December 11). Members—USS Theodore Roosevelt. knowingly providing false information
Summary of Guidance for Public Health MMWR, 69(23), 714–721. doi: https:// to their employer.
Strategies to Address High Levels of doi.org/10.15585/mmwr.mm6923e4. Paragraph (j) provides that employers
Community Transmission of SARS– (Payne et al., June 12, 2020) must provide the required information
CoV–2 and Related Deaths, December Schwartz K et al. (2020, April 14). Lack of
to each employee in a language and at
2020. MMWR Morb Mortal Wkly Rep COVID–19 transmission on an
2020; 69: 1860–1867. doi: http:// international flight. Canadian Medical a literacy level the employee
dx.doi.org/10.15585/mmwr.mm6949e2. Association Journal, 192(15), E410. doi: understands. This means that if an
(Honein et al., December 11, 2020) https://doi.org/10.1503/cmaj.75015. employer has employees that speak
Jehn M et al. (2021, October 1). Association (Schwartz et al., April 14, 2020) different languages or are at different
between K–12 school mask policies and Siegel J, Rhinehart E, Jackson M, Chiarello L, literacy levels, the employer must
school-associated COVID–19 outbreaks— and the Healthcare Infection Control present information in a way that
Maricopa and Pima Counties, Arizona, Practices Advisory Committee. (2007). ensures each employee can understand
July–August 2021. MMWR 70: 1372– 2007 Guideline for isolation precautions: it. This may require an employer to
1373. http://dx.doi.org/10.15585/ Preventing transmission of infectious
create different materials for different
mmwr.mm7039e1. (Jehn et al., October 1, agents in healthcare settings. https://
2021). www.cdc.gov/infectioncontrol/pdf/ groups of employees (e.g., materials in
Johansson MA et al. (2021, January 7). SARS– guidelines/isolation-guidelines-H.pdf. different languages). When information
CoV–2 transmission from people without (Siegel et al., 2007) must be translated into different
COVID–19 symptoms. JAMA Network Ueki H et al. (2020, October 21). Effectiveness languages, employers must ensure the
Open, 4(1), e2035057. https://doi.org/ of Face Masks in Preventing Airborne translation is one the employees can
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61543
understand. When an employer coverings, prior to the effective date of the contents of the document in a
provides employees with the required this ETS. Employers may rely on any language they understand. Employers
information in a manner employees such prior communications for purposes do not have any further obligations to
understand, they help ensure that their of complying with paragraph (j)(1) to the create or provide information on
implementation of this ETS is extent that the prior communications vaccine efficacy, safety, or the benefits
successful. meet the relevant requirements of of being vaccinated beyond providing
The manner in which employers paragraph (j) and there have been no the aforementioned CDC document to
provide the required information to changes to the relevant policies. each employee.
employees may vary based on the size Employers must review and evaluate the Paragraph (j)(3) requires employers to
and type of workplace. Employers have information already provided to inform each employee about the
flexibility to communicate this determine whether it covers all of the requirements of 29 CFR
information to employees using any information necessary under paragraph 1904.35(b)(1)(iv) and section 11(c) of the
effective methods that are typically used (j)(1). If previous information provided OSH Act. These two provisions work
in their workplaces, and may choose to employees did not cover all of the together to protect employees from
any method of informing employees so required elements, the employer must retaliation for engaging in activities
long as each employee receives the provide employees the information on protected by OSHA statute or
information specified in the standard in those missing elements to come into regulation. The first of these provisions,
a language and at a literacy level they compliance with the ETS. For example, section 1904.35(b)(1)(iv), prohibits
understand. For example, an employer if an employer has a mandatory employers from discharging or in any
may provide this information to vaccination policy and has already manner discriminating against any
employees through email provided information to the employees employee for reporting a work-related
communications, printed fact sheets, or on the policies and procedures the injury or illness. The second provision,
during a discussion at a regularly employer has established to implement section 11(c) of the OSH Act, prohibits
scheduled team meeting. To ensure that policy, and provided that employers from discriminating against
comprehension of the information information in a language and at a employees for exercising rights under,
provided, employers can identify a literacy level each employee can or as a result of actions required by, the
point-of-contact for employees who understand, the employer would not ETS. Section 11(c) also protects
have questions about the information need to expend resources to provide employees from retaliation for filing an
provided. that information again to meet the occupational safety or health complaint,
Paragraphs (j)(1)–(4) specify the requirements under this ETS. However, reporting a work-related injury or
information that employers must the employer would still need to illness, or otherwise exercising any
provide to employees. Paragraph (j)(1) provide information to its employees rights afforded by the OSH Act.
requires employers to provide each about other new policies and
employee with information regarding Retaliation takes many forms; it
procedures established to implement
the requirements of § 1910.501 and any occurs when an employer (through a
the ETS.
policies and procedures the employer When an employer’s policies or manager, supervisor, or administrator)
establishes to implement this ETS. The procedures change, the employer must fires an employee or takes any other
information provided to employees provide any updated or supplemental type of adverse employment action
must cover any employer policies under information to employees. For example, against an employee for engaging in a
paragraph (d), including the details of an employer may initially opt to allow protected activity. Adverse employment
the employer’s vaccination policy. only paper copies as proof of COVID–19 actions include discipline, reducing pay
Employers must also inform employees test results. Over time, however, the or hours, reassignment to a less
about the process that will be used to employer may decide that it wants to desirable position, denying overtime or
determine employee vaccination status, accept electronic proof of test results. If promotion, intimidation or harassment,
as required under paragraph (e). In that employer modifies its policy to and any other action that would
addition, employers must inform permit employees to submit electronic dissuade a reasonable employee from
employees about the time and pay/leave proof of test results, the employer must raising a concern about a possible
they are entitled to for vaccinations and inform employees of any new or altered violation or engaging in other protected
any side effects experienced following policies and procedures that the activity (see Burlington Northern &
vaccinations, as required by paragraph employer implements as a result. Santa Fe Railway Co. v. White, 548 U.S.
(f). And employers must also inform Paragraph (j)(2) requires employers to 53, 57 (2006) holding, in the Title VII
employees about the procedures they provide information to each employee context, that the test for determining
need to follow to provide notice of a about COVID–19 vaccine efficacy, whether a particular employment action
positive COVID–19 test or diagnosis of safety, and the benefits of being is materially adverse is whether it
COVID–19 by a licensed healthcare vaccinated. To meet this requirement, ‘‘could well dissuade’’ a reasonable
provider, as required under paragraph employers must provide the CDC’s person from engaging in protected
(h), as well as the procedures to be used document, ‘‘Key Things to Know About activity).
for requesting records under paragraph COVID–19 Vaccines,’’ available at The ETS does not change employers’
(l). Employers must provide additional https://www.cdc.gov/coronavirus/2019- substantive obligations under either 29
information to unvaccinated employees, ncov/vaccines/keythingstoknow.html CFR 1904.35(b)(1)(iv) or section 11(c) of
including information about the (CDC, October 7, 2021), to each the OSH Act. Rather, it simply requires
employer’s policies and procedures for employee. The employer may choose to employers to make employees aware of
COVID–19 testing and face coverings, as provide this information to employees these provisions and their requirements.
required by paragraphs (g) and (i), in either an electronic or print format. By increasing awareness, OSHA
respectively. The CDC currently provides this believes that paragraph (j)(3) will
Some employers may have informed document in multiple languages; prevent acts of retaliation from
employees about their COVID-related however, employers may need to occurring in the workplace, encourage
workplace-specific policies, e.g., provide additional translations if employees to exercise their right to the
policies on vaccination, testing, and face necessary to inform each employee of protections of the ETS, and engage
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61544 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
employees in actions required by the provides for fines or imprisonment for number of employees vaccinated and
ETS. persons who ‘‘knowingly and willfully’’ will facilitate effective implementation
It is critically important for employees (1) falsifies, conceals, or covers up by of the standard by employers.
to be aware of, and to be able to any trick, scheme, or device a material
exercise, their rights under the ETS. References
fact; (2) makes any materially false,
Employee participation is essential to fictitious, or fraudulent statement or Centers for Disease Control and Prevention
mitigating the spread of COVID–19 in representation; or (3) makes or uses any (CDC). (2021, October 7). Key Things to
the workplace, and fear of retaliation false writing or document knowing the Know About COVID–19 Vaccines.
would undermine the effectiveness of https://www.cdc.gov/coronavirus/2019-
same to contain any materially false,
ncov/vaccines/keythingstoknow.html.
the ETS. For example, per paragraph (f) fictitious, or fraudulent statement or (CDC, October 7, 2021).
of this ETS, employers must provide entry. And section 17(g) of the OSH Act Occupational Safety and Health
employees up to 4 hours of paid time at provides for fines up to $10,000, and Administration (OSHA). (2021,
the employee’s regular rate of pay for imprisonment for not more than six September 29). COVID–19 Response
each vaccination dose, as well as months, or both, for anyone who Summary: Summary Data for Federal
reasonable time and paid sick leave for ‘‘knowingly makes any false statement, Programs—Whistleblower Data. https://
employees to recover from side effects representation, or certification’’ in any www.whistleblowers.gov/covid-19-data.
experienced following any vaccination application, record, report, plan, or (OSHA, September 29, 2021).
dose. If an employer fails to comply other document ‘‘filed or required to be K. Reporting COVID–19 Fatalities and
with paragraph (f) and then retaliates maintained pursuant to this chapter.’’ Hospitalizations to OSHA
against employees who object, False statements or documents made or
employees may be deterred from being OSHA has required employers to
submitted for purposes of complying
vaccinated. Similarly, if employees fear report work-related fatalities and certain
with policies required by this ETS could
retaliation, they will be less likely to work-related hospitalizations under its
fall under either or both of these
voice concerns about unvaccinated co- recordkeeping regulation since 1971.
statutory provisions.
workers who do not wear required face This ETS requires that each employee These requirements have been an
coverings (see paragraph (i)(1)). A provide their employer either COVID– important part of the agency’s statutory
workplace free from the threat of 19 vaccination documentation mission to assure safe and healthful
retaliation promotes collaboration (paragraph (e)), or, if applicable, regular working conditions for all working
between employers and employees and COVID–19 test results (paragraph (g)). people. All employers covered by the
allows employers to more effectively There is a significant public health OSH Act, including employers who are
implement the various requirements of interest in ensuring employees provide partially exempt from maintaining
this ETS. this information truthfully to the injury and illness records, are required
OSHA has received a record number employer. Employers cannot effectively to comply with OSHA reporting
of complaints of retaliation during the implement the requirements of this ETS requirements at 29 CFR 1904.39. Under
COVID–19 pandemic. The agency’s based on false information. By OSHA’s current reporting regulation,
website shows that, as of September 26, increasing awareness of the possible employers are required to report each
2021, OSHA had received 5,788 penalties an employee may face for work-related fatality to OSHA within 8
complaints of retaliation related to misrepresenting their vaccination status hours of the event, and each work-
workplace protections from COVID–19 or test results, OSHA intends to related in-patient hospitalization,
(OSHA, September 29, 2021). These discourage such behavior. Employers amputation, and loss of an eye within
figures indicate that some employers can satisfy the requirement of paragraph 24 hours of the event.
need to be reminded that they are (j)(4) by providing each employee with The purpose of the reporting
legally prohibited from engaging in the text of the two statutory provisions requirement in § 1904.39 is to provide
retaliatory actions. Additionally, in hard copy or via electronic OSHA with information to determine
employees likely need reassurance of communication (e.g., email), translated whether it is necessary for the agency to
their legal right to engage in protected as necessary into other languages, conduct an immediate investigation at a
activity without fear of suffering from emphasizing the importance of specific establishment. Employer
adverse employment actions. As such, it providing truthful information about reports of work-related COVID–19
is critical for employers to inform vaccine status and test results, and fatalities and in-patient hospitalizations
employees of the prohibitions against explaining that providing false are an important element of the agency’s
retaliation in 29 CFR 1904.35(b)(1)(iv) information could be punishable under efforts to reduce occupational exposure
and section 11(c) after the effective date the two provisions. Employers are not to the virus. After receiving an employer
of the ETS, without regard to any required to provide further explanation report, OSHA decides whether an
information they may have provided of the statutory provisions or to provide inspection is needed to determine the
previously on these anti-retaliation legal advice. cause of a work-related COVID–19
provisions. As with the other parts of Information requirements are routine fatality or in-patient hospitalization, and
paragraph (j), employers have flexibility components of OSHA standards. The whether any OSHA standards may have
regarding how they will provide the inclusion of information requirements been violated. These reports are critical
required information. in this ETS reflects the agency’s for the agency to respond quickly to
Paragraph (j)(4) requires employers to conviction, as noted above, that COVID–19 exposure that may pose an
provide each employee with informed employees are essential to the ongoing risk to other employees at the
information regarding the prohibitions implementation of any effective worksite. Timely investigation also
of 18 U.S.C. 1001 and Section 17(g) of occupational safety and health policy or allows OSHA to view evidence at a
the OSH Act, which provide for procedure. OSHA believes that workplace soon after a work-related
criminal penalties associated with informing employees about their rights COVID–19 fatality or in-patient
knowingly supplying false statements or and responsibilities under the ETS; the hospitalization has occurred, and can
documentation. The first of these two employer’s policies and procedures; and make it easier for the agency to gather
provisions, 18 U.S.C. 1001(a) is the safety, efficacy, and benefits of relevant information from others at the
described earlier in this preamble and vaccination will help increase the worksite that might be useful in
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61545
protecting other employees. Moreover, mean ‘‘exposure’’ in the work to report the event. In this example, ‘‘the
prompt inspection enables OSHA to environment. Therefore, in order to be work-related incident’’ occurred on
gather information to evaluate whether reportable under 29 CFR 1904.39(a)(1), Monday when the employee tripped
its current standards adequately address a work-related fatality due to COVID–19 and was injured in the workplace. Also,
the workplace hazard presented from needed to have occurred within 30 days under § 1904.39, employers must report
COVID–19. The information gathered of an employee’s exposure in the work in-patient hospitalizations to OSHA
from employer reports is also used by environment. Given the possibility of within 24 hours of knowing both that
the agency to form the basis of statistical long-term illness before death, the 30- the employee has been in-patient
data on the causes and remediation of day limitation for reporting fatalities to hospitalized and that the reason for the
work-related COVID–19 fatalities and OSHA could restrict OSHA’s ability to hospitalization was the result of ‘‘the
in-patient hospitalizations. receive information about work-related work-related incident’’ (see 29 CFR
In order to address the unique COVID–19 fatalities. 1904.39(a)(2), (b)(7)–(b)(8)). In non-
circumstances presented by COVID–19, To address these issues, OSHA has COVID cases, the work-relatedness of
and to facilitate OSHA investigation and chosen not to apply the 30-day the injury is typically apparent
better workplace health surveillance, limitation period from 29 CFR immediately.
paragraph (k)(1) requires covered 1904.39(b)(6) to the reporting provision Since the beginning of the pandemic,
employers to report each work-related in paragraph (k) (see paragraph (k)(2)). the reporting of work-related COVID–19
COVID–19 fatality to OSHA within 8 Therefore, the requirement to report in-patient hospitalizations under 29
hours of the employer learning about these fatalities is not limited by the CFR 1904.39 has presented unique
the fatality, and each work-related length of time between workplace challenges. As noted above, for
COVID–19 in-patient hospitalization to exposure and death. The reporting of purposes of reporting COVID–19
OSHA within 24 hours of the employer work-related COVID–19 fatalities that fatalities and in-patient hospitalizations,
learning about the in-patient occur beyond 30 days from the time of OSHA has interpreted the phrase ‘‘the
hospitalization. As described in more exposure will enable the agency to work-related incident’’ in 29 CFR
detail in the following discussion, evaluate more work-related COVID–19 1904.39(b)(6) to mean an employee’s
OSHA is adding these additional fatalities to determine whether ‘‘exposure’’ to COVID–19 in the work
COVID–19 reporting requirements immediate investigations are needed to environment. Thus, in order to be
because the delay in the manifestation prevent other employees at the same reportable, an in-patient hospitalization
and progression of symptoms of worksite from being exposed to the needed to occur within 24 hours of an
COVID–19 can lead to hospitalization or virus. The report of these fatalities to employee’s exposure to COVID–19 in
fatality outside the normal window for OSHA facilitates the agency’s timely the work environment. Given the
reporting those workplace events. tracking of this data. Accordingly, incubation period of the virus, and the
Paragraph (k)(1)(i) provides that paragraph (k)(1)(i) requires employers to typical timeframe between exposure and
employers must report each work- report each work-related COVID–19 the emergence of symptoms serious
related COVID–19 fatality to OSHA fatality to OSHA within 8 hours of the enough to require hospitalization, it is
within 8 hours of the employer learning employer learning about the fatality extremely unlikely for an in-patient
about the fatality. Under this paragraph, regardless of when the exposure in the hospitalization to occur within 24 hours
an employer must make a report to work environment occurred. of an employee’s exposure to the virus.
OSHA within 8 hours of learning both Paragraph (k)(1)(ii) of the standard To address these issues, paragraph
(1) that an employee has died from a requires an employer to report each (k)(1)(ii) does not limit the COVID–19
confirmed case of COVID–19, and (2) work-related COVID–19 in-patient reporting requirement to only those
that the cause of death was the result of hospitalization to OSHA within 24 hospitalizations that occur within 24
a work-related exposure to COVID–19. hours of the employer learning about hours of exposure, as in 29 CFR
Employers are only required to report the in-patient hospitalization. Under 1904.39(b)(6). This change in the
confirmed cases of COVID–19 as this paragraph, and similar to OSHA’s reporting requirement will result in
defined by the Centers for Disease reporting regulation at 29 CFR 1904.39, OSHA making more determinations as
Control and Prevention (CDC) (CDC, an employer must make a report to to whether immediate investigations are
May 20, 2020). Typically, the cause of OSHA within 24 hours of learning that needed at additional worksites. Given
death is determined by the physician (1) an employee has been in-patient the severity of the disease, and how
who was responsible for a patient who hospitalized due to a confirmed case of quickly it can spread, it is essential that
died in a hospital, although the cause of COVID–19, and (2) the reason for the remediation efforts at a workplace be
death can also be determined by others hospitalization was the result of a work- undertaken immediately. As noted
such as medical examiners or coroners related exposure to the illness. above, it is critical for OSHA to respond
(Pappas, May 19, 2020). OSHA’s current reporting regulation quickly to hazardous conditions where
The requirement in paragraph (k)(1)(i) at 29 CFR 1904.39(a)(2) provides that, employees have been hospitalized. The
is similar to the fatality reporting within 24 hours after the in-patient elimination of the 24-hour limitation
requirement in OSHA’s regulation at 29 hospitalization of one or more period will not only allow OSHA to
CFR 1904.39(a)(1), which requires an employees, as the result of a work- receive more employer reports about
employer to report to OSHA within 8 related incident, an employer must work-related COVID–19 in-patient
hours after the death of any employee as report the in-patient hospitalization to hospitalizations and, as a result, shed
the result of a work-related incident. OSHA. 29 CFR 1904.39(b)(6) requires light on where severe COVID–19 events
However, 29 CFR 1904.39(b)(6) requires employers to only report in-patient are occurring, but it will also enable the
employers to report a work-related hospitalizations to OSHA if the agency to respond more quickly and
fatality to OSHA only if the fatality hospitalization occurs within 24 hours effectively to these situations.
occurs within 30 days of ‘‘the work- of the work-related incident. For Accordingly, employers must report
related incident.’’ Prior to this ETS, for example, if an employee trips in the each work-related COVID–19 in-patient
purposes of reporting events involving workplace and sustains an injury on hospitalization to OSHA regardless of
COVID–19, OSHA interpreted the Monday, but is not hospitalized until when the employee’s exposure in the
phrase ‘‘the work-related incident’’ to Thursday, the employer does not need workplace occurred (paragraph
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61546 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
(k)(1)(ii)). But consistent with OSHA’s Because of the typical incubation fatality and in-patient hospitalization is
normal reporting requirements, when period of 3 to 14 days, an employee’s no different than the requirement to
hospitalization for a work-related case exposure to COVID–19 will usually be determine work-relatedness when
of COVID–19 does occur, the employer determined after the fact. Employers entering fatalities, injuries and illness
must report it within 24 hours of must make reasonable efforts to acquire on the OSH 300 log. Accordingly, the
learning about the hospitalization. the necessary information to make good- work-relatedness determination for
Additionally, for purposes of this faith work-relatedness determinations reporting COVID–19 fatalities and in-
section, OSHA defines in-patient under this section. In addition, the patient hospitalizations is a
hospitalization as a formal admission to employer should rely on information determination that is already required to
the in-patient services of a hospital or that is reasonably available at the time be made by the employer.
clinic for care or treatment (see 29 CFR of the fatality or in-patient
1904.39(b)(9) and (b)(10)). The hospitalization. II. Time Periods for Reporting COVID–
determination as to whether an A work-related exposure in the work 19 Fatalities and In-Patient
employee is formally admitted into the environment would likely include close Hospitalizations
in-patient service is made by the contact with a person known to be As noted above, under paragraph (k),
hospital or clinic. Treatment in an infected with COVID–19. For example, employers must report each work-
Emergency Room only is not reportable. although work-relatedness must be related COVID–19 fatality or
determined on a case-by-case basis, if a hospitalization to OSHA within the
I. Work-Relatedness Determinations
number of COVID–19 illnesses develop specified timeframes based on when any
Given the nature of the disease, and among coworkers who work closely agent or employee of the employer
the extent of community spread, in together without an alternative becomes aware of the reportable event.
some cases, it may be difficult for an explanation, it is reasonable to conclude For example, an employer ‘‘learns’’ of a
employer to determine whether an that an employee’s fatality or in-patient COVID–19 fatality or in-patient
employee’s COVID–19 illness is work- hospitalization is work-related. On the hospitalization when a supervisor,
related, especially when an employee other hand, if there is not a known receptionist, or other employee at the
has experienced potential exposure both exposure to COVID–19 that would company receives information from a
in and out of the workplace. For trigger the presumption of work- family member or medical professional
purposes of this ETS, when evaluating relatedness, the employer must evaluate
whether a fatality or in-patient about an employee fatality or in-patient
the employee’s work duties and hospitalization. It is the employer’s
hospitalization is the result of a work- environment to determine whether it is
related case of COVID–19, employers responsibility to ensure that appropriate
more likely than not that the employee instructions and procedures are in place
must follow the criteria in OSHA’s was exposed to COVID–19 during the
recordkeeping regulation at 29 CFR so that managers, supervisors, medical
course of their employment. Employers personnel, as well as other employees or
1904.5 for determining work- should consider factors such as:
relatedness. Applying the criteria in 29 agents of the company, who learn of an
• The type, extent, and duration of employee’s death or in-patient
CFR 1904.5 under paragraph (k) of this contact the employee had at the work
ETS is consistent with how employers hospitalization due to COVID–19 know
environment with other people, that the company must make a report to
make work-relatedness determinations particularly the general public.
when reporting fatalities and other OSHA.
• Physical distancing and other
serious events under 29 CFR 1904.39. controls that impact the likelihood of Consistent with OSHA’s regulation at
Under § 1904.5, employers must work-related exposure. 29 CFR 1904.39, the reporting clock
consider an injury or illness to be work- • The extent and duration of time begins to run with the occurrence of the
related if an event or exposure in the spent in a shared indoor space with reportable event. Under paragraph (k),
work environment either caused or limited ventilation. in situations where the employer or the
contributed to the resulting condition, • Whether the employee had work- employer’s agent does not learn about
or significantly aggravated a pre-existing related contact with anyone who the work-related COVID–19 fatality or
injury or illness. An injury or illness is exhibited signs and symptoms of in-patient hospitalization right away,
presumed work-related if it results from COVID–19. the employer must make the report to
events or exposures occurring in the Since 1971, under OSHA’s OSHA within 8 hours for a fatality, or
work environment, unless an exception recordkeeping system, employers have 24 hours for an in-patient
in § 1904.5(b)(2) specifically applies. been making work-relatedness hospitalization, from the time the
Under this language, an injury or illness determinations regarding workplace employer (or the employer’s agent)
is presumed work-related if an event or fatalities, injuries, and illnesses. In learns about the reportable event. For
exposure in the work environment is a general, employers are in the best example, if an employee dies from a
discernable cause of the injury or illness position to obtain information, both work-related case of COVID–19 on
(see 66 FR 66,943 (December 27, 2001)). from the employee and the workplace, Sunday at 6:00 a.m., but the employer
According to 29 CFR 1904.5(b)(3), the necessary to make a work-relatedness does not learn about the death until
‘‘work environment’’ includes the determination. Although employers may Monday at 8:00 a.m., the employer has
employer’s establishment and any other rely on experts and healthcare until 4:00 p.m. that day to make the
location where work is performed or professionals for guidance, the report to OSHA. Similarly, if an
where employees are present as a determination of work-relatedness employee is in-patient hospitalized for a
condition of their employment. Under ultimately rests with the employer. work-related case of COVID–19 at 8:30
29 CFR 1904.5(b)(3), employers should Finally, OSHA wishes to emphasize p.m. on Monday, but the employer or
evaluate the employee’s work duties that, under OSHA’s recordkeeping the employer’s agent(s) does not learn
and environment and determine regulation at 29 CFR 1904, employers about the hospitalization until 9:00 a.m.
whether it is more likely than not that must record on the OSHA 300 log each the next day (Tuesday), then the
exposure at work caused or contributed work-related fatality, injury, and illness employer would be required to make the
to the illness (see 66 FR 5958–59 reported to OSHA under § 1904.39. The report to OSHA within 24 hours of
(January 19, 2001)). work-relatedness determination for learning of the in-patient hospitalization
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61547
(i.e., by 9:00 a.m. on Wednesday) (see 29 Office that is nearest to the site of the of the Act specifically directs the
CFR 1904.39(b)(7)). incident. However, because many Secretary of Labor to promulgate
Likewise, if an employer does not OSHA Area Offices are closed to the regulations requiring employers to
learn right away that a reportable public during the COVID–19 pandemic, maintain accurate records of work-
fatality or in-patient hospitalization is employers must use one of the three related injuries and illnesses. Section
work-related, the employer must make options listed above. In addition, 8(c)(3) of the Act requires employers to
the report to OSHA within 8 hours or § 1904.39(b)(1) makes clear that, if the ‘‘maintain accurate records of employee
24 hours of learning that the death or in- OSHA Area Office is closed, an exposures to potentially toxic materials
patient hospitalization was the result of employer may not report a work-related or harmful physical agents which are
a work-related COVID–19 exposure. For fatality or in-patient hospitalization by required to be monitored or measured
example, if an employee is in-patient leaving a message on OSHA’s answering under section 6 [of the Act.]’’ In
hospitalized for a case of COVID–19 at machine, faxing the Area Office, or accordance with section 8(c), paragraph
9:00 a.m. on Monday, but the employer sending an email. Instead, the employer (l) of the ETS includes availability of
does not have enough information to must make the report by using the 800 records requirements for certain
make a work-relatedness determination number or the reporting application COVID–19-related records required to
until 11:00 a.m. on Monday, then the located on OSHA’s public website at be created and maintained by the ETS.
employer would be required to report www.osha.gov. This paragraph provides a right of
the hospitalization within 24 hours of The other provisions in 29 CFR access to records by employees,
learning that the hospitalization was 1904.39 (except for 29 CFR employee representatives, and OSHA.
work-related (i.e., by 11:00 a.m. on 1904.39(a)(1)–(2) and (b)(6)) also apply Paragraph (l)(1) specifies that the
Tuesday) (see 29 CFR 1904.39(b)(8)). to the reports required by paragraph (k). employer must make available, for
Finally, if an employer makes a report For example, employers should consult examination and copying, the
to OSHA concerning a work-related 29 CFR 1904.39(b)(2) to determine what individual COVID–19 vaccine
COVID–19 in-patient hospitalization information employers must give to documentation and any COVID–19 test
and that employee subsequently dies OSHA when making COVID–19 fatality results required by the ETS for a
from the illness, the employer does not or in-patient hospitalization reports. Per particular employee to that employee
need to make an additional fatality that provision, employers must give and to anyone having written
report to OSHA. OSHA the following information for authorized consent of that employee by
each fatality or in-patient the end of the next business day after a
III. How To Report COVID–19 Fatalities hospitalization: The establishment request. Prompt employee access to this
and In-Patient Hospitalizations and name, the location of the work-related information ensures that employees
What Information Must Be Included in incident, the time of the work-related have the information necessary to take
the Report incident, the type of reportable event an active role in their employers’ efforts
Paragraph (k)(2) of the standard (i.e., fatality or in-patient to prevent COVID–19 transmission in
provides that when reporting work- hospitalization), the number of the workplace. In particular, in
related COVID–19 fatalities and in- employees who suffered a fatality or in- circumstances where employers or
patient hospitalizations to OSHA in patient hospitalization, the names of the employees choose to have the
accordance with paragraph (k)(1), the employees who suffered a fatality or in- employee’s COVID–19 test results go
employer must follow the requirements patient hospitalization, the employer’s directly to the employer, paragraph
in 29 CFR 1904.39, except for 29 CFR contact person and his or her phone (l)(1) gives the employee access to their
parts 1904.39(a)(1)–(2) and (b)(6). As number, and a brief description of the own records. Access to COVID–19 test
explained above, OSHA has included work-related incident. results may be helpful for a requesting
specific provisions for the reporting of employee in evaluating information
work-related COVID–19 fatalities and References relevant to COVID–19 exposure,
in-patient hospitalizations that differ Centers for Disease Control and Prevention. including if that exposure occurred at
from 29 CFR 1904.39. However, when (2020, May 20). Reporting and Coding the workplace. Prompt production of
making COVID–19 fatality and in- Deaths Due to COVID–19. https:// these records can also assist employees
patient hospitalization reports to OSHA, www.cdc.gov/nchs/covid19/coding-and- in making personal medical decisions
reporting.htm. (CDC, May 20, 2020).
employers must follow the other Pappas, S. (2020, May 19). How COVID–19
and seeking care from a licensed
reporting procedures set forth in Deaths are Counted. Scientific American. healthcare provider if necessary.
§ 1904.39. Specifically, under https://www.scientificamerican.com/ Employers should note that employee
§ 1904.39(a)(3), employers have three article/how-covid-19-deaths-are- privacy is protected under the access to
options for reporting work-related counted1/. (Pappas, May 19, 2020). records provisions in paragraph (l)(1).
fatalities and in-patient hospitalizations Specifically, as noted above, paragraph
L. Availability of Records (l)(1) requires employers to provide
to OSHA:
1. By telephone to the OSHA Area Section 8(c)(1) of the Act requires access to the vaccination records or
Office that is nearest to the site of the employers to ‘‘make, keep and preserve, COVID–19 test results for a particular
incident; and make available to the Secretary [of employee to that employee or to anyone
2. by telephone to the OSHA toll-free Labor] or the Secretary of Health and having that employee’s written
central telephone number, 1–800–321– Human Services, such records regarding permission. However, it does not
OSHA (1–800–321–6742); his activities relating to this Act as the authorize employers to allow anyone
3. by electronic submission using the Secretary, in cooperation with the other than the particular employee to
reporting application located on Secretary of Health and Human access their records or results without
OSHA’s public website at Services, may prescribe by regulation as the written consent of that employee
www.osha.gov. necessary or appropriate for the (except as provided for under paragraph
Section 1904.39(a)(3) also allows enforcement of this Act or for (l)(3)).
employers to report work-related developing information regarding the Paragraph (l)(2) requires the employer
fatalities and in-patient hospitalizations causes and prevention of occupational to make the following information
to OSHA in person to the OSHA Area accidents and illnesses.’’ Section 8(c)(2) available to an employee or an
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61548 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
employee representative on request: (1) These interpretations are limited to instead of being fully vaccinated. This
The aggregate number of fully these provisions. information also provides OSHA
vaccinated employees at a workplace Under paragraphs (l)(1) and (l)(2), representatives with the ability to
and (2) the total number of employees requesters are entitled to one free copy quickly check any vaccination claims
at that workplace. This information of each requested record, which is made by an employer without
must be made available to these consistent with OSHA’s recordkeeping undertaking an employee-by-employee
individuals by the end of the next regulation at 29 CFR 1904.35. The cost assessment and assists OSHA
business day after a request. Employers of providing one free copy to representatives in their evaluation of the
will be able to utilize the roster of each employees, former employees, and/or effectiveness of the employer’s written
employee’s vaccination status they are their representatives is minimal, and policy.
required to maintain under paragraph these individuals are more likely to Having this information within 4
(e)(4) of this section to provide this access the records if it is without cost. business hours of the request helps the
information promptly to a requester. Allowing the employer to charge for a agency act more quickly to protect
Since the aggregate totals of fully copy of the record would only delay the employees and preserves agency
vaccinated employees and total production of the information. After resources. In addition, the 4-hour
employees made available by request in receiving an initial, free copy of a response time is consistent with similar
paragraph (l)(2) do not contain any requested record or document, an obligations under other OSHA
personal identifiable information or employee, former employee, or recordkeeping requirements, such as the
personal medical information, OSHA representative may be charged a recordkeeping requirement in 29 CFR
does not believe that access to these reasonable fee for copying duplicative 1904.40(a).
records raises any serious records. However, no fee may be Paragraph (l)(3)(ii) requires employers
confidentiality or privacy concern if charged for an update to a previously to provide all other records and other
disclosed to employees or their requested record. It should be noted that documents that are required to be
representatives. each COVID–19 test is a separate record, maintained by this section to the
OSHA believes that access to this and, as such, the employee or the Assistant Secretary for examination and
information will allow employees and representative is entitled to one free copying by the end of the next business
employee representatives to calculate a copy of each COVID–19 test record. day after a request. This means that
percentage of fully vaccinated Paragraph (l)(3) provides OSHA with employers must allow OSHA
employees at a workplace, evaluate the a specific right of access. Under representatives to examine and copy
efficacy of the employer’s vaccination paragraph (l)(3)(i), employers must each employee’s COVID–19 vaccine
policy, raise any concerns identified to provide the written policy required by documentation (required to be
OSHA, and actively participate in the paragraph (d), and the aggregate maintained under paragraph (e)(4)), the
employer’s vaccination efforts. Without numbers described in paragraph (l)(2) of roster of employee vaccination status
the provision of this information to this section (both the aggregate number (required to be maintained under
employees and their representatives, the of fully vaccinated employees at a paragraph (e)(4)), and each employee’s
only potential check on whether the workplace and the total number of COVID–19 test results (required to be
employer is complying with the employees at that workplace), to the maintained under paragraph (g)(4)),
requirements of the ETS would be Assistant Secretary for examination and upon request.
OSHA inspections. The agency believes copying within 4 business hours of a As indicated in paragraph (c), the
that making this information available request. Consistent with the term Assistant Secretary includes the
to employee representatives will help requirements in 29 CFR 1904.40(b)(2), if Assistant Secretary’s designees.
ensure compliance with the the records are maintained at a location Consequently, the records and
requirements of the ETS and thereby in a different time zone, the employer information required to be provided to
protect workers. may use the business hours of the the Assistant Secretary under paragraph
Consistent with 29 CFR 1904.35(a)(3), establishment at which the records are (l)(3) must be given to the Assistant
OSHA interprets the term ‘‘employee’’ located when calculating the deadline. Secretary or their representatives, such
as used in paragraph (l) to include Providing OSHA with prompt access as OSHA’s Compliance Safety and
former employees. In addition, for to the written policy and the aggregate Health Officers.
purposes of paragraph (l)(2), the term numbers allows the agency to more As noted above, section 8 of the OSH
‘‘representative’’ is intended to have the rapidly focus inspections on employers Act recognizes OSHA’s right of access to
same meanings as in 29 CFR that may not be in compliance with the records relating to employer compliance
1904.35(b)(2), which encompasses two requirements of this ETS. In addition, with occupational safety and health
types of employee representatives. The this information will help OSHA standards and regulations, including
first is a personal representative of the determine what to focus on in an access to relevant employee medical
employee, who is a person the employee investigation. For example, if an records. OSHA does not believe that its
designates, in writing, as his or her employer has established, implemented, inspectors need to obtain employee
personal representative, or is a legal and is enforcing a written mandatory permission to access and review
representative of a deceased or legally vaccination policy under paragraph personally identifiable information.
incapacitated employee. The second is (d)(1) and their aggregate numbers Gaining this permission would
an authorized representative, which is indicate that their entire workforce is essentially make it impossible to obtain
defined as an authorized collective fully vaccinated against COVID–19, the full access to the records in a timely
bargaining agent of one or more agency might approach the investigation manner, which is needed by OSHA to
employees working at the employer’s differently than in a workplace where perform a meaningful workplace
worksite. In accordance with these the employer’s written policy (under investigation. OSHA also has policies
interpretations, OSHA also interprets paragraph (d)(2)) allows employees to and procedures in place to ensure the
the phrase ‘‘employee representative,’’ provide proof of regular testing for privacy and confidentiality of employee
as used in paragraph (l)(2), to include COVID–19 in accordance with records it accesses during inspections.
the personal and authorized paragraph (g) and wear a face covering Finally, without complete and timely
representatives of former employees. in accordance with paragraph (i), access to the vaccine and testing
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61549
records, agency efforts to conduct same time, OSHA has set the For the Pfizer-BioNTech COVID–19
immediate interventions to ensure compliance dates to allow enough time vaccine, the primary vaccination series
employees are protected from COVID– for employers to obtain and read the takes 21 days to complete (CDC, August
19 at a specific workplace would be standard, become knowledgeable about 25, 2021). Employees receiving the
limited. the standard’s requirements, and Pfizer-BioNTech series could begin their
OSHA does not prescribe specific undertake the necessary steps for primary vaccination series up to 39 days
methods for requests for records in this compliance. from the date of publication in the
ETS. Employees, employee OSHA anticipates that employers will Federal Register. Finally, for the
representatives, and the Assistant be able to implement measures to Moderna COVID–19 vaccine, the
Secretary and designees can submit comply with most provisions of the ETS primary vaccination series takes 28 days
requests in any manner that provides well within 30 days, pursuant to to complete (CDC, August 23, 2021).
adequate notice of the request to the paragraph (m)(2)(i). Even in situations Employees receiving the Moderna series
employer. This may include requests by where an employer has not previously could therefore begin their primary
in writing (e.g., email, fax, letter), by taken the required actions to address vaccination series up to 32 days from
phone, or in person. COVID–19 hazards in the workplace, the date of publication in the Federal
steps such as developing a vaccination Register.
M. Dates
policy, determining employee As specified in paragraph (m)(2)(ii), if
To minimize transmission of COVID– vaccination status, providing support an employee completes the entire
19 in the workplace, it is essential that for employee vaccination, ensuring primary vaccination within 60 days
employers ensure that the provisions of employees who are not fully vaccinated following publication in the Federal
this ETS are implemented as quickly as wear face coverings, and most other Register, that employee does not have to
possible, but no later than the dates measures required under the standard be tested under paragraph (g), even if
outlined in paragraph (m). This can readily be completed within the 30- they have not yet completed the two
paragraph sets forth the effective date of day time period. These measures do not week waiting period that is required to
the section and the compliance dates for require extensive lead times for large meet the definition of fully vaccinated
specific requirements of the standard. employers to implement. The scope of in paragraph (c). Employers must begin
The effective date for this ETS, as the standard is limited to employers compliance with the testing
required by section 6(c)(1) of the OSH with more than 100 employees largely requirements of paragraph (g) only for
Act (29 U.S.C. 655(c)(1)), is the date of because OSHA is especially confident employees who have not yet completed
publication in the Federal Register. The that these employers will have the primary vaccination (i.e., employees
compliance date for all provisions in the ability to implement the standard. who have not received any doses,
ETS is 30 days after the effective date, Paragraph (m)(2)(ii) of the ETS employees who have received only one
except for paragraph (g) (COVID–19 provides a longer period of time—60 dose of a two-dose series) within 60
testing for employees who are not fully days—for employers to comply with the days from the date of publication in the
vaccinated), which requires compliance requirements for COVID–19 testing in Federal Register. And because
within 60 days of the effective date. paragraph (g). Paragraph (g) requires employers must have their vaccination
Given the grave danger to employees employers to implement COVID–19 support processes (as required by
from occupational exposure to COVID– testing and reporting of results for paragraph (f)) in place before employees
19, as previously described, the effective employees who are not fully vaccinated. would need to initiate their primary
date and compliance dates provided for One reason for this extended period of vaccination in time to avoid testing
this ETS are reasonable and appropriate. time for testing is that employers may under this section, employees will be
For over a year and a half—since at need additional time to develop policies able to avoid all testing costs required
least January 2020, when the Secretary and procedures regarding COVID–19 by this ETS.
of Health and Human Services declared testing and associated recordkeeping. Compliance with the requirements of
COVID–19 to be a public health Perhaps more critically, this ETS is the ETS within the specified dates is
emergency for the entire United States— intended to incentivize vaccination, so achievable. Many employers are likely
all employers have been made acutely this delayed compliance date was already in compliance with at least
aware of the importance of minimizing established to allow sufficient time for some of the provisions of the ETS.
employees’ exposure to COVID–19 and employees to complete a COVID–19 Resources are also readily available to
many have willingly joined the global primary vaccination before it is help employers achieve compliance.
response to stop the spread of COVID– necessary to comply with the testing These resources include guidance
19 and to protect their employees. requirements in paragraph (g). The 60- issued by OSHA, the CDC, state and
Therefore, many employers have day compliance period in paragraph local governments, trade associations,
already been encouraging their (m)(2)(ii) provides employees with and other organizations to help
employees to get vaccinated against sufficient time to receive one dose of a employers successfully implement
COVID–19. Many employers have also single-dose primary vaccination (e.g., vaccination, testing, and face covering
instituted vaccination mandates (see Janssen (Johnson & Johnson)) or both requirements to minimize the
Technological Feasibility, Section IV.A. doses of a two-dose primary vaccination transmission of COVID–19 in the
of this preamble, for more information). series (e.g., Pfizer-BioNTech, Moderna). workplace. OSHA therefore concludes
OSHA has published this ETS For the Janssen COVID–19 vaccine, the that the compliance dates in this ETS
because there is great urgency in primary vaccination takes 1 day to strike a reasonable balance between
instituting the workplace protections complete (CDC, August 10, 2021). incentivizing vaccination and allowing
OSHA has found to be necessary as Employees who receive the Janssen enough time for employers to comply.
quickly as possible. Unvaccinated vaccine could therefore begin their Although employers are not required
workers are being hospitalized with primary vaccination at any time up to to comply with the requirements of this
COVID–19 every day, and many are and including the 60th day from the ETS until 30 days from the date of
dying, so it is particularly critical to date of publication in the Federal publication in the Federal Register (60
remove obstacles as soon as possible for Register in order to be exempt from the days for paragraph (g)), OSHA strongly
those who wish to be vaccinated. At the testing requirements of paragraph (g). encourages employers to implement the
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61550 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
required measures to support employee the ETS. While either ETS remains in In this section, OSHA includes a list
vaccination as soon as practicable. effect, it is OSHA’s intent that 29 CFR of the titles, editions/versions, and years
Providing support for employees to 1910.505 remain in subpart U and of the incorporated documents.
receive the COVID–19 vaccine and operative as to either ETS still in effect. Stakeholders may consult 29 CFR
recover from side effects, as required in If both ETSs are not made permanent, 1910.509 both to locate all of the
paragraph (f) of the ETS, prior to the 29 CFR 1910.505 will cease to have documents incorporated by reference in
compliance date may encourage effect along with the rest of subpart U. subpart U (the paragraph in which the
employees to receive a COVID–19 If either ETS is made permanent, OSHA document is incorporated is listed there)
vaccination at the earliest possible date. will provide notice at that time of the and to find more details regarding how
This would not only reduce the grave agency’s intended application of 29 CFR to locate the specific consensus
danger of COVID–19 in the workplace 1910.505 to the newly permanent standard and guidelines that have been
but also reduce burdens on both standard. For example, if 29 CFR incorporated by reference in the ETS.
employers and employees when the 1910.502 becomes permanent because it OSHA recognizes that the Centers for
compliance dates for the additional has been finalized, but 29 CFR 1910.501 Disease Control and Prevention (CDC)
requirements for employees who are not remains a temporary requirement may update their guidelines based on
fully vaccinated arrive. because it is not yet finalized, 29 CFR the most current available scientific
1910.505 would remain in subpart U evidence, but OSHA is only requiring
References
and operative as to 29 CFR 1910.501 compliance with CDC’s ‘‘Isolation
Centers for Disease Control and Prevention and the agency would separately Guidance’’ as incorporated by reference,
(CDC). (2021, August 10). Janssen provide notice of how severability is
COVID–19 Vaccine (Johnson & Johnson).
which is fixed in time as of February 18,
intended to apply to the newly 2021.
https://www.cdc.gov/vaccines/covid-19/
info-by-product/moderna/index.html.
permanent 29 CFR 1910.502. As discussed in the preamble of the
(CDC, August 10, 2021) O. Incorporation by Reference Healthcare ETS at 86 FR 32619, CDC’s
Centers for Disease Control and Prevention guidance, including its ‘‘Isolation
(CDC). (2021, August 23). Moderna OSHA’s amendment to its COVID–19
ETS, Part 1910, Subpart U, includes the Guidance,’’ is not expressed in
COVID–19 Vaccine. https:// mandatory terms. As such, OSHA has
www.cdc.gov/vaccines/covid-19/info-by- addition of § 1910.501, Vaccination,
product/moderna/index.html. (CDC, Testing, and Face Coverings. This determined it is not sufficiently
August 23, 2021) section incorporates by reference CDC’s protective or a meaningful alternative to
Centers for Disease Control and Prevention ‘‘Isolation Guidance.’’ a mandatory standard. OSHA has
(CDC). (2021, August 25). Pfizer- This document, listed below, will be reviewed this guidance and determined
BioNTech COVID–19 Vaccine. https:// that compliance with the safety
fixed in time and made publicly
www.cdc.gov/vaccines/covid-19/info-by- measures and specific instructions in
product/pfizer/index.html. (CDC, August available. OSHA had previously
incorporated this same document into CDC’s ‘‘Isolation Guidance’’ is
25, 2021)
29 CFR 1910.502 and listed it in subpart important to protect workers who work
N. Severability U’s incorporation by reference (IBR) for employees with over 100 employees.
OSHA’s amendment to its COVID–19 section, 29 CFR 1910.509. Because For the same reasons as described in the
ETS, Part 1910, Subpart U, includes a subpart U is the result of two separate Healthcare ETS (86 FR 32619), OSHA is
republication of § 1910.505, ETSs published at different times and incorporating this guidance by
Severability. Section 1910.505 contains subject to different time frames, but both reference, and compliance with the
a severability clause, the primary incorporate documents by reference, recommendations will be mandatory.
purpose of which is to express OSHA’s OSHA has relied on the same OSHA will be able to cite employers
intent that if any section or provision of centralized IBR section for both. For the who do not follow them. Compliance
the COVID–19 ETS is held invalid or benefit of the reader and for with all applicable provisions of the
unenforceable or is stayed or enjoined administrative convenience, this incorporated document is required
by any court of competent jurisdiction, centralized IBR section is located in the where the provisions into which they
the remaining sections or provisions same subpart as the other provisions of are incorporated are mandatory,
should remain effective and operative. the ETS. whether the incorporated document sets
OSHA is including 29 CFR 1910.505 as While either ETS remains in effect, it out its directions in mandatory language
part of this ETS for the same reasons the is OSHA’s intent that 29 CFR 1910.509 or recommendations. OSHA recognizes
agency included the provision in the remain in subpart U. If both ETSs are that this document incorporated by
Healthcare ETS, and OSHA intends for not made permanent, 29 CFR 1910.509 reference into the ETS may become
it to have the same purposes and effects will cease to have effect along with the outdated when newer versions are
as those expressed in the preamble to rest of subpart U. If either ETS is made published or other entities revise those
the Healthcare ETS (86 FR 32617– permanent, OSHA intends to recodify documents. In that case, OSHA will
32618), which is hereby included in the the relevant standards for that ETS from work quickly to update the ETS through
record for this ETS. 29 CFR 1910.509 into 29 CFR 1910.6, a new rulemaking or issue enforcement
Because subpart U is the result of two the centralized IBR section for part guidance, as appropriate. But OSHA
separate ETSs published at different 1910. For example, if 29 CFR 1910.502 also has a longstanding de minimis
times and subject to different time becomes permanent because it has been enforcement policy to allow employers
frames, but OSHA intends for both ETSs finalized, but 29 CFR 1910.501 remains to rely on documents that are at least as
to be subject to the same principles of a temporary requirement because it is protective.
severability, OSHA has relied on the not yet finalized, OSHA would relocate OSHA is incorporating by reference
same centralized severability section for all of 29 CFR 1910.502’s incorporated (in 29 CFR 1910.509) the material
both for efficiency. For the benefit of the documents into 29 CFR 1910.6, but 29 below. A brief description of the
reader and for administrative CFR 1910.509 would remain in subpart guidance is provided in the text below.
convenience, this centralized U and would list the one document A description of its use can be found in
severability section is located in the incorporated by reference into 29 CFR the Regulatory Text, and Summary and
same subpart as the other provisions of 1910.501. Explanation (Section VI. of this
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Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61551
preamble), where the guidance is PART 1910—OCCUPATIONAL SAFETY Assistant Secretary means the
referenced. AND HEALTH STANDARDS Assistant Secretary of Labor for
Occupational Safety and Health, U.S.
Regulatory Text—§§ 1910.501(h); Subpart U—COVID–19 Department of Labor, or designee.
1910.502(l) COVID–19 (Coronavirus Disease 2019)
■ 1. Revise the heading for Subpart U to means the disease caused by SARS–
CDC’s Isolation Guidance (2021): This
read as set forth above. CoV–2 (severe acute respiratory
guidance provides steps to take when
■ 2. The authority citation for subpart U syndrome coronavirus 2). For clarity
someone is experiencing COVID–19
symptoms and/or tested positive for continues to read as follows: and ease of reference, this section also
COVID–19. This document is available Authority: 29 U.S.C. 653, 655, and 657; uses the term ‘‘COVID–19’’ when
at www.osha.gov/coronavirus/ets/ibr. Secretary of Labor’s Order No. 8–2020 (85 FR describing exposures or potential
The CDC document is available at no
58393); 29 CFR part 1911; and 5 U.S.C. 553. exposures to SARS–CoV–2.
cost through the contact information ■ 3. Add § 1910.501 to subpart U to read COVID–19 test means a test for SARS–
listed above. In addition, in accordance as follows: CoV–2 that is:
(i) Cleared, approved, or authorized,
with § 1910.509(a)(1), this guidance is § 1910.501 Vaccination, testing, and face including in an Emergency Use
available for inspection at any Regional coverings. Authorization (EUA), by the FDA to
Office of the Occupational Safety and (a) Purpose. This section is intended detect current infection with the SARS–
Health Administration (OSHA), or at the to establish minimum vaccination, CoV–2 virus (e.g., a viral test);
OSHA Docket Office, U.S. Department vaccination verification, face covering, (ii) Administered in accordance with
of Labor, 200 Constitution Avenue NW, and testing requirements to address the the authorized instructions; and
Room N–3508, Washington, DC 20210; grave danger of COVID–19 in the (iii) Not both self-administered and
telephone: 202–693–2350 (TTY number: workplace, and to preempt inconsistent self-read unless observed by the
877–889–5627). Due to copyright issues, state and local requirements relating to employer or an authorized telehealth
OSHA cannot post consensus standards these issues, including requirements proctor. Examples of tests that satisfy
on the OSHA website or through that ban or limit employers’ authority to this requirement include tests with
www.regulations.gov. require vaccination, face covering, or specimens that are processed by a
List of Subjects testing, regardless of the number of laboratory (including home or on-site
employees. collected specimens which are
29 CFR Part 1910 processed either individually or as
Note 1 to paragraph (a): This section
COVID–19, Disease, Health, Health establishes minimum requirements that pooled specimens), proctored over-the-
care, Health facilities, Incorporation by employers must implement. Nothing in this counter tests, point of care tests, and
reference, Occupational safety and section prevents employers from agreeing tests where specimen collection and
with workers and their representatives to processing is either done or observed by
health, Public health, Quarantine,
additional measures not required by this an employer.
Reporting and recordkeeping section and this section does not supplant
requirements, Respirators, SARS–CoV– Face covering means a covering that:
collective bargaining agreements or other (i)(A) completely covers the nose and
2, Telework, Vaccines, Viruses. collectively negotiated agreements in effect
that may have negotiated terms that exceed
mouth;
29 CFR Parts 1915, 1917, 1918, 1926, (B) Is made with two or more layers
the requirements herein. The National Labor
and 1928 Relations Act of 1935 (NLRA) protects the of a breathable fabric that is tightly
right of most private-sector employees to take woven (i.e., fabrics that do not let light
COVID–19, Disease, Health, Health
collective action to improve their wages and pass through when held up to a light
care, Health facilities, Occupational
working conditions. source);
safety and health, Public health, (C) Is secured to the head with ties,
Quarantine, Reporting and (b) Scope and application. (1) This
section covers all employers with a total ear loops, or elastic bands that go
recordkeeping requirements, behind the head. If gaiters are worn,
Respirators, SARS–CoV–2, Telework, of 100 or more employees at any time
this section is in effect. they should have two layers of fabric or
Vaccines, Viruses. be folded to make two layers;
(2) The requirements of this section
Authority and Signature do not apply to: (D) Fits snugly over the nose, mouth,
(i) Workplaces covered under the and chin with no large gaps on the
James S. Frederick, Acting Assistant outside of the face; and
Safer Federal Workforce Task Force
Secretary of Labor for Occupational (E) Is a solid piece of material without
COVID–19 Workplace Safety: Guidance
Safety and Health, U.S. Department of slits, exhalation valves, visible holes,
for Federal Contractors and
Labor, authorized the preparation of this punctures, or other openings.
Subcontractors; or
document pursuant to the following (ii) This definition includes clear face
(ii) Settings where any employee
authorities: Sections 4, 6, and 8 of the coverings or cloth face coverings with a
provides healthcare services or
Occupational Safety and Health Act of clear plastic panel that, despite the non-
healthcare support services when
1970 (29 U.S.C. 653, 655, 657); Secretary cloth material allowing light to pass
subject to the requirements of
of Labor’s Order 8–2020 (85 FR 58393 through, otherwise meet this definition
§ 1910.502.
(Sept. 18, 2020)); 29 CFR part 1911; and (3) The requirements of this section and which may be used to facilitate
5 U.S.C. 553. do not apply to the employees of communication with people who are
James S. Frederick, covered employers: deaf or hard-of-hearing or others who
(i) Who do not report to a workplace need to see a speaker’s mouth or facial
Acting Assistant Secretary of Labor for
Occupational Safety and Health. where other individuals such as expressions to understand speech or
coworkers or customers are present; sign language respectively.
For the reasons set forth in the (ii) While working from home; or Facemask means a surgical, medical
preamble, chapter XVII of title 29 of the (iii) Who work exclusively outdoors. procedure, dental, or isolation mask that
Code of Federal Regulations is amended (c) Definitions. The following is FDA-cleared, authorized by an FDA
as follows: definitions apply to this section. EUA, or offered or distributed as
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61552 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
described in an FDA enforcement (surrounding) air or by supplying (ii) A copy of the COVID–19
policy. Facemasks may also be referred breathable air from a safe source. Vaccination Record Card;
to as ‘‘medical procedure masks.’’ Common types of respirators include (iii) A copy of medical records
Fully vaccinated means: filtering facepiece respirators (e.g., N95), documenting the vaccination;
(i) A person’s status 2 weeks after elastomeric respirators, and powered air (iv) A copy of immunization records
completing primary vaccination with a purifying respirators (PAPRs). Face from a public health, state, or tribal
COVID–19 vaccine with, if applicable, coverings, facemasks, and face shields immunization information system; or
at least the minimum recommended are not respirators. (v) A copy of any other official
interval between doses in accordance Workplace means a physical location documentation that contains the type of
with the approval, authorization, or (e.g., fixed, mobile) where the vaccine administered, date(s) of
listing that is: employer’s work or operations are administration, and the name of the
(A) Approved or authorized for performed. It does not include an health care professional(s) or clinic
emergency use by the FDA; employee’s residence. site(s) administering the vaccine(s);
(B) Listed for emergency use by the (d) Employer policy on vaccination. (vi) In instances where an employee is
World Health Organization (WHO); or (1) The employer must establish, unable to produce acceptable proof of
(C) Administered as part of a clinical implement, and enforce a written vaccination under paragraphs (e)(2)(i)
trial at a U.S. site, if the recipient is mandatory vaccination policy. through (v) of this section, a signed and
documented to have primary (2) The employer is exempted from dated statement by the employee:
vaccination with the active (not the requirement in paragraph (d)(1) of (A) Attesting to their vaccination
placebo) COVID–19 vaccine candidate, this section only if the employer status (fully vaccinated or partially
for which vaccine efficacy has been establishes, implements, and enforces a vaccinated);
independently confirmed (e.g., by a data (B) Attesting that they have lost and
written policy allowing any employee
and safety monitoring board) or if the are otherwise unable to produce proof
not subject to a mandatory vaccination
clinical trial participant at U.S. sites had required by this section; and
policy to choose either to be fully (C) Including the following language:
received a COVID–19 vaccine that is vaccinated against COVID–19 or provide
neither approved nor authorized for use ‘‘I declare (or certify, verify, or state)
proof of regular testing for COVID–19 in that this statement about my vaccination
by FDA but is listed for emergency use accordance with paragraph (g) of this
by WHO; or status is true and accurate. I understand
section and wear a face covering in that knowingly providing false
(ii) A person’s status 2 weeks after accordance with paragraph (i) of this
receiving the second dose of any information regarding my vaccination
section. status on this form may subject me to
combination of two doses of a COVID–
19 vaccine that is approved or Note 1 to paragraph (d): Under federal law, criminal penalties.’’
authorized by the FDA, or listed as a including the Americans with Disabilities
Act (ADA) and Title VII of the Civil Rights Note 1 to paragraph (e)(2)(vi): An
two-dose series by the WHO (i.e., a employee who attests to their vaccination
Act of 1964, workers may be entitled to a
heterologous primary series of such reasonable accommodation from their status should, to the best of their recollection,
vaccines, receiving doses of different employer, absent undue hardship. If the include the following information in their
COVID–19 vaccines as part of one worker requesting a reasonable attestation: The type of vaccine administered;
primary series). The second dose of the accommodation cannot be vaccinated and/or date(s) of administration; and the name of the
health care professional(s) or clinic site(s)
series must not be received earlier than wear a face covering because of a disability,
as defined by the ADA, the worker may be administering the vaccine(s).
17 days (21 days with a 4-day grace
period) after the first dose. entitled to a reasonable accommodation. In (3) Any employee who does not
Mandatory Vaccination Policy is an addition, if the vaccination, and/or testing for provide one of the acceptable forms of
employer policy requiring each COVID–19, and/or wearing a face covering proof of vaccination status in paragraph
conflicts with a worker’s sincerely held (e)(2) of this section to the employer
employee to be fully vaccinated. To religious belief, practice or observance, the
meet this definition, the policy must worker may be entitled to a reasonable
must be treated as not fully vaccinated
require: Vaccination of all employees, accommodation. For more information about for the purpose of this section.
including vaccination of all new evaluating requests for reasonable (4) The employer must maintain a
employees as soon as practicable, other accommodation for disability or sincerely record of each employee’s vaccination
than those employees: held religious belief, employers should status and must preserve acceptable
(i) For whom a vaccine is medically consult the Equal Employment Opportunity proof of vaccination for each employee
contraindicated; Commission’s regulations, guidance, and who is fully or partially vaccinated. The
(ii) For whom medical necessity technical assistance including at: https:// employer must maintain a roster of each
requires a delay in vaccination; or www.eeoc.gov/wysk/what-you-should-know- employee’s vaccination status. These
(iii) Who are legally entitled to a about-covid-19-and-ada-rehabilitation-act- records and roster are considered to be
and-other-eeo-laws.
reasonable accommodation under employee medical records and must be
federal civil rights laws because they (e) Determination of employee maintained as such records in
have a disability or sincerely held vaccination status. (1) The employer accordance with § 1910.1020 and must
religious beliefs, practices, or must determine the vaccination status of not be disclosed except as required or
observances that conflict with the each employee. This determination authorized by this section or other
vaccination requirement. must include whether the employee is federal law. These records and roster are
Respirator means a type of personal fully vaccinated. not subject to the retention requirements
protective equipment (PPE) that is (2) The employer must require each of § 1910.1020(d)(1)(i) but must be
certified by the National Institute for vaccinated employee to provide maintained and preserved while this
Occupational Safety and Health acceptable proof of vaccination status, section remains in effect.
(NIOSH) under 42 CFR part 84 or is including whether they are fully or (5) When an employer has ascertained
authorized under an EUA by the FDA. partially vaccinated. Acceptable proof of employee vaccination status prior to the
Respirators protect against airborne vaccination status is: effective date of this section through
hazards by removing specific air (i) The record of immunization from another form of attestation or proof, and
contaminants from the ambient a health care provider or pharmacy; retained records of that ascertainment,
App. 152
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61553
the employer is exempt from the result as required by paragraph (g)(1) of (i) Face coverings. (1) The employer
requirements in paragraphs (e)(1) this section, the employer must keep must ensure that each employee who is
through (3) of this section only for each that employee removed from the not fully vaccinated wears a face
employee whose fully vaccinated status workplace until the employee provides covering when indoors and when
has been documented prior to the a test result. occupying a vehicle with another
effective date of this section. For (3) When an employee has received a person for work purposes, except:
purposes of paragraph (e)(4) of this positive COVID–19 test, or has been (i) When an employee is alone in a
section, the employer’s records of diagnosed with COVID–19 by a licensed room with floor to ceiling walls and a
ascertainment of vaccination status for healthcare provider, the employer must closed door.
each such person constitute acceptable not require that employee to undergo (ii) For a limited time while the
proof of vaccination. COVID–19 testing as required under employee is eating or drinking at the
(f) Employer support for employee paragraph (g) of this section for 90 days workplace or for identification purposes
vaccination. The employer must following the date of their positive test in compliance with safety and security
support COVID–19 vaccination as or diagnosis. requirements.
described in this paragraph. (4) The employer must maintain a (iii) When an employee is wearing a
(1) Time for vaccination. The record of each test result provided by respirator or facemask.
employer must: (iv) Where the employer can show
each employee under paragraph (g)(1) of
(i) Provide a reasonable amount of that the use of face coverings is
this section or obtained during tests
time to each employee for each of their infeasible or creates a greater hazard
primary vaccination dose(s); and conducted by the employer. These
records are considered to be employee that would excuse compliance with this
(ii) Provide up to 4 hours paid time, paragraph (e.g., when it is important to
including travel time, at the employee’s medical records and must be
maintained as such records in see the employee’s mouth for reasons
regular rate of pay for this purpose. related to their job duties, when the
(2) Time for recovery. The employer accordance with § 1910.1020 and must
not be disclosed except as required or work requires the use of the employee’s
must provide reasonable time and paid uncovered mouth, or when the use of a
sick leave to recover from side effects authorized by this section or other
federal law. These records are not face covering presents a risk of serious
experienced following any primary
subject to the retention requirements of injury or death to the employee).
vaccination dose to each employee for (2) The employer must ensure that
each dose. § 1910.1020(d)(1)(i) but must be
maintained and preserved while this any face covering required to be worn
(g) COVID–19 testing for employees
section remains in effect. by this section:
who are not fully vaccinated. (1) The
(i) Is worn by the employee to fully
employer must ensure that each (h) Employee notification to employer
cover the employee’s nose and mouth;
employee who is not fully vaccinated of a positive COVID–19 test and
and
complies with paragraph (g)(1)(i) or (ii) removal. Regardless of COVID–19
(ii) Is replaced when wet, soiled, or
of this section: vaccination status or any COVID–19
(i) An employee who reports at least damaged (e.g., is ripped, has holes, or
testing required under paragraph (g) of
once every 7 days to a workplace where has broken ear loops).
this section, the employer must: (3) The employer must not prevent
other individuals such as coworkers or (1) Require each employee to
customers are present: any employee from voluntarily wearing
promptly notify the employer when a face covering or facemask unless the
(A) Must be tested for COVID–19 at they receive a positive COVID–19 test or
least once every 7 days; and employer can demonstrate that doing so
are diagnosed with COVID–19 by a would create a hazard of serious injury
(B) Must provide documentation of licensed healthcare provider; and
the most recent COVID–19 test result to or death, such as interfering with the
(2) Immediately remove from the safe operation of equipment.
the employer no later than the 7th day workplace any employee who receives a
following the date on which the (4) The employer must permit the
positive COVID–19 test or is diagnosed employee to wear a respirator instead of
employee last provided a test result.
with COVID–19 by a licensed healthcare a face covering whether required or not.
(ii) An employee who does not report
provider and keep the employee In addition, the employer may provide
during a period of 7 or more days to a
removed until the employee: respirators to the employee, even if not
workplace where other individuals such
as coworkers or customers are present (i) Receives a negative result on a required. In such circumstances, the
(e.g., teleworking for two weeks prior to COVID–19 nucleic acid amplification employer must also comply with
reporting to a workplace with others): test (NAAT) following a positive result § 1910.504.
(A) Must be tested for COVID–19 on a COVID–19 antigen test if the (5) The employer must not prohibit
within 7 days prior to returning to the employee chooses to seek a NAAT test customers or visitors from wearing face
workplace; and for confirmatory testing; coverings.
(B) Must provide documentation of (ii) meets the return to work criteria Note 1 to paragraph (i)(5): Nothing in this
that test result to the employer upon in CDC’s ‘‘Isolation Guidance’’ section precludes employers from requiring
return to the workplace. (incorporated by reference, § 1910.509); customers or visitors to wear face coverings.
Note 1 to paragraph (g)(1): This section
or
(iii) Receives a recommendation to Note 1 to paragraph (i): Face shields may
does not require the employer to pay for any
return to work from a licensed be worn in addition to face coverings to
costs associated with testing; however
healthcare provider. prevent them from getting wet and soiled.
employer payment for testing may be
required by other laws, regulations, or
Note 1 to paragraph (h)(2): This section Note 2 to paragraph (i): This section does
collective bargaining agreements or other
does not require employers to provide paid not require the employer to pay for any costs
collectively negotiated agreements. This
time to any employee for removal as a result associated with face coverings; however
section also does not prohibit the employer
of a positive COVID–19 test or diagnosis of employer payment for face coverings may be
from paying for costs associated with testing
required by paragraph (g)(1) of this section. COVID–19; however, paid time may be required by other laws, regulations, or
required by other laws, regulations, or collective bargaining agreements or other
(2) If an employee does not provide collective bargaining agreements or other collectively negotiated agreements. This
documentation of a COVID–19 test collectively negotiated agreements. section also does not prohibit the employer
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61554 Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations
from paying for costs associated with face must make available to the requester the (b) * * *
coverings required by this section. aggregate number of fully vaccinated (5) Isolation Guidance. COVID–19:
(j) Information provided to employees. employees at a workplace along with Isolation If You Are Sick; Separate
The employer must inform each the total number of employees at that yourself from others if you have
employee, in a language and at a literacy workplace. COVID–19, updated February 18, 2021,
level the employee understands, about: (3) The employer must provide to the IBR approved for §§ 1910.501(h) and
(1) The requirements of this section as Assistant Secretary for examination and 1910.502(l).
well as any employer policies and copying: * * * * *
procedures established to implement (i) Within 4 business hours of a
this section; request, the employer’s written policy PART 1915—OCCUPATIONAL SAFETY
(2) COVID–19 vaccine efficacy, safety, required by paragraph (d) of this AND HEALTH STANDARDS FOR
and the benefits of being vaccinated, by section, and the aggregate numbers SHIPYARD EMPLOYMENT
providing the document, ‘‘Key Things to described in paragraph (l)(2) of this
section; and ■ 7. The authority citation for part 1915
Know About COVID–19 Vaccines,’’
(ii) By the end of the next business is revised to read as follows:
available at https://www.cdc.gov/
coronavirus/2019-ncov/vaccines/ day after a request, all other records and Authority: 33 U.S.C. 941; 29 U.S.C. 653,
keythingstoknow.html; other documents required to be 655, 657; Secretary of Labor’s Order No. 12–
(3) The requirements of 29 CFR maintained by this section. 71 (36 FR 8754); 8–76 (41 FR 25059), 9–83
(m) Dates—(1) Effective date. This (48 FR 35736), 1–90 (55 FR 9033), 6–96 (62
1904.35(b)(1)(iv), which prohibits the
section is effective as of November 5, FR 111), 3–2000 (65 FR 50017), 5–2002 (67
employer from discharging or in any FR 65008), 5–2007 (72 FR 31160), 4–2010 (75
2021.
manner discriminating against an (2) Compliance dates. (i) Employers FR 55355), 1–2012 (77 FR 3912), or 8–2020
employee for reporting a work-related must comply with all requirements of (85 FR 58393); 29 CFR part 1911; and 5
injuries or illness, and section 11(c) of this section, except for requirements in U.S.C. 553, as applicable.
the OSH Act, which prohibits the paragraph (g) of this section, by
employer from discriminating against an Subpart Z—Toxic and Hazardous
December 6, 2021. Substances
employee for exercising rights under, or (ii) Employers must comply with the
as a result of actions that are required requirements of this section in ■ 8. Add § 1915.1501 to subpart Z to
by, this section. Section 11(c) also paragraph (g) by January 4, 2022, but
protects the employee from retaliation read as follows:
employees who have completed the
for filing an occupational safety or entire primary vaccination by that date § 1915.1501 COVID–19.
health complaint, reporting a work- do not have to be tested, even if they The requirements applicable to
related injuries or illness, or otherwise have not yet completed the 2-week shipyard employment under this section
exercising any rights afforded by the waiting period. are identical to those set forth at 29 CFR
OSH Act; and ■ 4. Amend § 1910.504 by revising 1910.501.
(4) The prohibitions of 18 U.S.C. 1001 paragraph (a) to read as follows:
and of section 17(g) of the OSH Act, PART 1917—MARINE TERMINALS
which provide for criminal penalties § 1910.504 Mini Respiratory Protection
associated with knowingly supplying Program. ■ 9. The authority citation for part 1917
false statements or documentation. (a) Scope and application. This is revised to read as follows:
(k) Reporting COVID–19 fatalities and section applies only to respirator use in Authority: 33 U.S.C. 941; 29 U.S.C. 653,
hospitalizations to OSHA. (1) The accordance with §§ 1910.501(i)(4) and 655, 657; Secretary of Labor’s Order No. 12–
employer must report to OSHA: 1910.502(f)(4). 71 (36 FR 8754), 8–76 (41 FR 25059), 9–83
(i) Each work-related COVID–19 * * * * * (48 FR 35736), 1–90 (55 FR 9033), 6–96 (62
fatality within 8 hours of the employer FR 111), 3–2000 (65 FR 50017), 5–2002 (67
■ 5. Republish § 1910.505 to read as
learning about the fatality. FR 65008), 5–2007 (72 FR 31160), 4–2010 (75
follows: FR 55355), 1–2012 (77 FR 3912), or 8–2020
(ii) Each work-related COVID–19 in-
(85 FR 58393), as applicable; and 29 CFR part
patient hospitalization within 24 hours § 1910.505 Severability.
1911.
of the employer learning about the in- Each section of this subpart U, and Sections 1917.28 and 1917.31 also issued
patient hospitalization. each provision within those sections, is under 5 U.S.C. 553.
(2) When reporting COVID–19 separate and severable from the other Section 1917.29 also issued under 49
fatalities and in-patient hospitalizations sections and provisions. If any provision U.S.C. 1801–1819 and 5 U.S.C. 553.
to OSHA in accordance with paragraph of this subpart is held to be invalid or
(j)(1) of this section, the employer must unenforceable on its face, or as applied Subpart B—Marine Terminal
follow the requirements in 29 CFR part to any person, entity, or circumstance, Operations
1904.39, except for 29 CFR part or is stayed or enjoined, that provision
■ 10. Add § 1917.31 to subpart B to read
1904.39(a)(1) and (2) and (b)(6). shall be construed so as to continue to
(l) Availability of records. (1) By the give the maximum effect to the as follows:
end of the next business day after a provision permitted by law, unless such § 1917.31 COVID–19.
request, the employer must make holding shall be one of utter invalidity The requirements applicable to
available, for examination and copying, or unenforceability, in which event the marine terminal work under this section
the individual COVID–19 vaccine provision shall be severable from this are identical to those set forth at 29 CFR
documentation and any COVID–19 test subpart and shall not affect the 1910.501.
results for a particular employee to that remainder of the subpart.
employee and to anyone having written ■ 6. Amend § 1910.509 by revising PART 1918—SAFETY AND HEALTH
authorized consent of that employee. paragraph (b)(5) to read as follows: REGULATIONS FOR LONGSHORING
(2) By the end of the next business
day after a request by an employee or an § 1910.509 Incorporation by reference. ■ 11. The authority citation for part
employee representative, the employer * * * * * 1918 is revised to read as follows:
App. 154
Federal Register / Vol. 86, No. 212 / Friday, November 5, 2021 / Rules and Regulations 61555
Authority: 33 U.S.C. 941; 29 U.S.C. 653, (29 U.S.C. 653, 655, 657); Secretary of Labor’s DATES:
655, 657; Secretary of Labor’s Order No. 12– Order No. 12–71 (36 FR 8754), 8–76 (41 FR Effective date: These regulations are
71 (36 FR 8754), 8–76 (41 FR 25059), 9–83 25059), 9–83 (48 FR 35736), 1–90 (55 FR effective on November 5, 2021.
(48 FR 35736), 1–90 (55 FR 9033), 6–96 (62 9033), 6–96 (62 FR 111), 3–2000 (65 FR Implementation dates: The
FR 111), 3–2000 (65 FR 50017), 5–2002 (67 50017), 5–2002 (67 FR 65008), 4–2010 (75 FR
regulations included in Phase 1 [42 CFR
FR 65008), 5–2007 (72 FR 31160), 4–2010 (75 55355), or 8–2020 (85 FR 58393), as
FR 55355), 1–2012 (77 FR 3912), or 8–2020 applicable; and 29 CFR 1911. 416.51(c) through (c)(3)(i) and (c)(3)(iii)
(85 FR 58393), as applicable; and 29 CFR Section 1928.21 also issued under 49 through (x), 418.60(d) through (d)(3)(i)
1911. U.S.C. 1801–1819 and 5 U.S.C. 553. and (d)(3)(iii) through (x), 441.151(c)
Sections 1918.90 and 1918.110 also issued through (c)(3)(i) and (c)(3)(iii) through
under 5 U.S.C. 553. Subpart B—Applicability of Standards (x), 460.74(d) through (d)(3)(i) and
Section 1918.100 also issued under 49 (d)(3)(iii) through (x), 482.42(g) through
U.S.C. 5101 et seq. and 5 U.S.C. 553. ■ 16. Amend § 1928.21 by adding (g)(3)(i) and (g)(3)(iii) through (x),
■ 12. Add subpart K to part 1918 to read
paragraph (a)(8) to read as follows: 483.80(d)(3)(v) and 483.80(i) through
as follows: § 1928.21 Applicable standards in 29 CFR (i)(3)(i) and (i)(3)(iii) through (x),
part 1910. 483.430(f) through (f)(3)(i) and (f)(3)(iii)
Subpart K—COVID–19. (a) * * * through (x), 483.460(a)(4)(v), 484.70(d)
(8) COVID–19—§ 1910.501, but only through (d)(3)(i) and (d)(3)(iii) through
Sec.
1918.107–1918.109 [Reserved] with respect to— (x), 485.58(d)(4), 485.70(n) through
1918.110 COVID–19. (i) Agricultural establishments where (n)(3)(i) and (n)(3)(iii) through (x),
1918.107 through 1918.109 [Reserved] eleven (11) or more employees are 485.640(f) through (f)(3)(i) and (f)(3)(iii)
engaged on any given day in hand-labor through (x), 485.725(f) through (f)(3)(i)
§ 1918.110 COVID–19. operations in the field; and through (f)(3)(iii) through (x), 485.904(c)
The requirements applicable to (ii) Agricultural establishments that through (c)(3)(i) and (c)(3)(iii) through
longshoring work under this section are maintain a temporary labor camp, (x), 486.525(c) through (c)(3)(i) and
identical to those set forth at 29 CFR regardless of how many employees are (c)(3)(iii) through (x), 491.8(d) through
1910.501. engaged on any given day in hand-labor (d)(3)(i) and (d)(3)(iii) through (x),
operations in the field. 494.30(b) through (b)((3)(i) and (b)(3)(iii)
PART 1926—SAFETY AND HEALTH through (x) must be implemented by
* * * * *
REGULATIONS FOR CONSTRUCTION [FR Doc. 2021–23643 Filed 11–4–21; 8:45 am] December 6, 2021.
The regulations included in Phase 2
■ 13. The authority citation for part BILLING CODE 4510–26–P
[42 CFR 416.51(c)(3)(ii), 418.60(d)(3)(ii),
1926 is revised to read as follows: 441.151(c)(3)(ii), 460.74(d)(3)(ii),
Authority: 40 U.S.C. 3704; 29 U.S.C. 653, DEPARTMENT OF HEALTH AND 482.42(g)(3)(ii), 483.80(i)(3)(ii),
655, and 657; and Secretary of Labor’s Order HUMAN SERVICES 483.430(f)(3)(ii), 484.70(d)(3)(ii),
No. 12–71 (36 FR 8754), 8–76 (41 FR 25059), 485.70(n)(3)(ii), 485.640(f)(3)(ii),
9–83 (48 FR 35736), 1–90 (55 FR 9033), 6– Centers for Medicare & Medicaid 485.725(f)(3)(ii), 485.904(c)(3)(ii),
96 (62 FR 111), 3–2000 (65 FR 50017), 5–
2002 (67 FR 65008), 5–2007 (72 FR 31159), Services 486.525(c)(3)(ii), 491.8(d)(3)(ii),
4–2010 (75 FR 55355), 1–2012 (77 FR 3912), 494.30(b)(3)(ii)] must be implemented
or 8–2020 (85 FR 58393), as applicable; and 42 CFR Parts 416, 418, 441, 460, 482, by January 4, 2022. Staff who have
29 CFR part 1911. 483, 484, 485, 486, 491 and 494 completed a primary vaccination series
Sections 1926.58, 1926.59, 1926.60, and
[CMS–3415–IFC] by this date are considered to have met
1926.65 also issued under 5 U.S.C. 553 and these requirements, even if they have
29 CFR part 1911. RIN 0938–AU75 not yet completed the 14-day waiting
Section 1926.61 also issued under 49
period required for full vaccination.
U.S.C. 1801–1819 and 5 U.S.C. 553. Medicare and Medicaid Programs;
Section 1926.62 also issued under sec.
Comment date: To be assured
Omnibus COVID–19 Health Care Staff consideration, comments must be
1031, Public Law 102–550, 106 Stat. 3672 (42 Vaccination
U.S.C. 4853). received at one of the addresses
Section 1926.65 also issued under sec. 126, AGENCY: Centers for Medicare & provided below, no later than 5 p.m. on
Public Law 99–499, 100 Stat. 1614 (reprinted Medicaid Services (CMS), HHS. January 4, 2022.
at 29 U.S.C.A. 655 Note) and 5 U.S.C. 553. ACTION: Interim final rule with comment ADDRESSES: In commenting, please refer
period. to file code CMS–3415–IFC.
Subpart D—Occupational Health and Comments, including mass comment
Environmental Controls SUMMARY: This interim final rule with submissions, must be submitted in one
comment period revises the of the following three ways (please
■ 14. Add § 1926.58 to read as follows:
requirements that most Medicare- and choose only one of the ways listed):
§ 1926.58 COVID–19. Medicaid-certified providers and 1. Electronically. You may submit
The requirements applicable to suppliers must meet to participate in the electronic comments on this regulation
construction work under this section are Medicare and Medicaid programs. to http://www.regulations.gov. Follow
identical to those set forth at 29 CFR These changes are necessary to help the ‘‘Submit a comment’’ instructions.
1910.501 Subpart U. protect the health and safety of 2. By regular mail. You may mail
residents, clients, patients, PACE written comments to the following
PART 1928—OCCUPATIONAL SAFETY participants, and staff, and reflect address ONLY: Centers for Medicare &
AND HEALTH STANDARDS FOR lessons learned to date as a result of the Medicaid Services, Department of
AGRICULTURE COVID–19 public health emergency. Health and Human Services, Attention:
The revisions to the requirements CMS–3415–IFC, P.O. Box 8016,
■ 15. The authority citation for part establish COVID–19 vaccination Baltimore, MD 21244–8016.
1928 is revised to read as follows: requirements for staff at the included Please allow sufficient time for mailed
Authority: Sections 4, 6, and 8 of the Medicare- and Medicaid-certified comments to be received before the
Occupational Safety and Health Act of 1970 providers and suppliers. close of the comment period.
App. 155
Appendix 2
App. 156
United States Court of Appeals
for the Fifth Circuit
United States Court of Appeals
Fifth Circuit
FILED
November 6, 2021
No. 21-60845 Lyle W. Cayce
Clerk
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
App. 157
No. 21-60845
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 Standard 2 (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).
2
App. 158
No. 21-60845
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.
3
App. 159
Appendix 3
App. 160
Case: 21-60845 Document: 00516091902 Page: 1 Date Filed: 11/12/2021
United States Court of Appeals
for the Fifth Circuit
United States Court of Appeals
Fifth Circuit
FILED
November 12, 2021
No. 21-60845 Lyle W. Cayce
Clerk
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
App. 161
Case: 21-60845 Document: 00516091902 Page: 2 Date Filed: 11/12/2021
No. 21-60845
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
2
App. 162
Case: 21-60845 Document: 00516091902 Page: 3 Date Filed: 11/12/2021
No. 21-60845
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 anticipated 4 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.
3
App. 163
Case: 21-60845 Document: 00516091902 Page: 4 Date Filed: 11/12/2021
No. 21-60845
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 standing 6 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).
4
App. 164
Case: 21-60845 Document: 00516091902 Page: 5 Date Filed: 11/12/2021
No. 21-60845
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.
5
App. 165
Case: 21-60845 Document: 00516091902 Page:6 Date Filed: 11/12/2021
No. 21-60845
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 doctrine*—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 today®—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 provides that ‘[al]ll legislative Powers herein granted
shall be vested in a Congress of the United States’ ... and we have long insisted that ‘the
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))).
° But see infra subsection II.A.2.f.
App. 166
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threat). The Mandate’s stated impetus—a purported “emergency” that the
entire globe has now endured for nearly two years,'° and which OSHA itself
spent nearly two months responding to!!—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,” the Administration pored over the U.S.
Code in search of authority, or a “work-around,” * 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”).
" 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.htm]
(“‘We’ve been patient, but our patience is wearing thin, and your refusal has cost all of us,’
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).
? See supra note 11.
3 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 zs 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).
App. 167
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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
‘unusual response’ to ‘exceptional circumstances.’” Jnt’] 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
§ 655(c) “is an ‘extraordinary power’ that is to be ‘delicately exercised’ in
only certain ‘limited situations.’” Jd. at 370 (quoting Pub. Citizen, 702 F.2d
at 1155).4
But the Mandate at issue here is anything Jut 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.
* 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].
App. 168
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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.
9
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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 Dept, 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? Chem. Workers, 830 F.2d
at 371 (noting OSHA’s stated view “that a finding of ‘grave danger’ to
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-19] ‘clusters’
and ‘outbreaks’ and other significant ‘evidence of workplace transmission’
and ‘exposure.’” 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
10
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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’! Chem. Workers, 830
F.2d at 371 (noting that OSHA itself once concluded “that to be a ‘grave
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 percent’ 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 vot to do so. It is thus
© See CDC, Covip DaTa TRACKER, https://covid.cdc.gov/covid-data-
tracker/#datatracker-home.
11
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critical to note that the Mandate makes no serious attempt to explain why
OSHA and the President himself” 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
constitute a ‘grave danger’ for which an ETS is an appropriate remedy”).
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 ». Fox, 556 U.S. at 515. OSHA’s
reversal here strains credulity, as does its pretextual basis. 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
” 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”’).
12
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No. 21-60845
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
13
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No. 21-60845
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
14
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No. 21-60845
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.
15
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No. 21-60845
(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
16
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No. 21-60845
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
17
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No. 21-60845
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.
18
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No. 21-60845
liberty interests 21 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).
19
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No. 21-60845
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
20
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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.
21
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No. 21-60845
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
to exercise powers of ‘vast economic and political significance.’” Ala. Ass°n
of Realtors v. Dept 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. OHSA 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 VFIB v. Sebelius,
567 U.S. 519, 549-61 (2012). Whether OSHA can do so does not.
I concur in granting a stay.
22
App. 182
Appendix 4
App. 183
Case: 21-7000 Document: 380-2 Filed: 12/15/2021 Page: 1
RECOMMENDED FOR PUBLICATION
Pursuant to Sixth Circuit I.O.P. 32.1(b)
File Name: 21a0283p.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 > Nos. 21-7000
SERVICES, LLC (21-4027); PHILLIPS MANUFACTURING & TOWER COMPANY, et /4027 /4028 /4031
al. (21-4028); COMMONWEALTH OF KENTUCKY, et al. (21-4031); ANSWERS IN /4032 /4033 /4080
GENESIS, INC. (21-4032); SOUTHERN BAPTIST THEOLOGICAL SEMINARY, et al. /4082 /4083 /4084
(21-4033); BST HOLDINGS, LLC, et al. (21-4080); REPUBLICAN NATIONAL /4085 /4086 /4087
/4089 /4088 /4090
COMMITTEE (21-4082); ASSOCIATED BUILDERS AND CONTRACTORS, INC., et al. /4091 /4093 /4092
(21-4083); MASSACHUSETTS BUILDING TRADES COUNCIL (21-4084); UNION OF /4095 /4094 /4096
AMERICAN PHYSICIANS AND DENTISTS (21-4085); ASSOCIATED GENERAL /4097 /4099 /4100
CONTRACTORS OF AMERICA, INC., et al. (21-4086); NATIONAL ASSOCIATION OF /4101 /4102 /4103
BROADCAST EMPLOYEES & TECHNICIANS, THE BROADCASTING AND CABLE /4108 /4112 /4114
TELEVISION WORKERS SECTOR OF THE COMMUNICATIONS WORKERS OF /4115 /4117 /4133
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.
App. 184
Case: 21-7000 Document: 380-2 Filed: 12/15/2021 Page: 2
Nos. 21-7000, et al. In re: MCP No. 165, Occupational Safety & Page 2
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
On Petitions for Initial Hearing En Banc.
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 15, 2021
Before: SUTTON, Chief Judge; MOORE, COLE, CLAY, GIBBONS, GRIFFIN,
KETHLEDGE, WHITE, STRANCH, DONALD, THAPAR, BUSH, LARSEN,
NALBANDIAN, READLER and MURPHY, Circuit Judges.
_________________
COUNSEL
ON PETITIONS FOR INITIAL HEARING EN BANC: 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 Ensign, OFFICE OF THE ARIZONA
ATTORNEY GENERAL, Phoenix, Arizona, John V. Coghlan, OFFICE OF THE MISSISSIPPI
ATTORNEY GENERAL, Jackson, Mississippi, 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 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, Ryan
Schelhaas, OFFICE OF THE WYOMING ATTORNEY GENERAL, Cheyenne, Wyoming,
App. 185
Case: 21-7000 Document: 380-2 Filed: 12/15/2021 Page: 3
Nos. 21-7000, et al. In re: MCP No. 165, Occupational Safety & Page 3
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
Michael E. Toner, Thomas M. Johnson, Jr., Stephen J. Obermeier, Jeremy J. Broggi, Krystal B.
Swendsboe, WILEY REIN LLP, Washington, D.C., Jeffrey C. Mateer, Hiram S. Sasser III,
David J. Hacker, Jeremiah G. Dys, Lea E. Patterson, Keisha T. Russell, FIRST LIBERTY
INSTITUTE, Plano, Texas, Cathleen A. Martin, John A. Ruth, NEWMAN, COMLEY & RUTH,
P.C., Jefferson City, Missouri, Robert Henneke, Chance Weldon, TEXAS PUBLIC POLICY
FOUNDATION, Austin, Texas, Matthew J. Clark, ALABAMA CENTER FOR LAW AND
LIBERTY, Birmingham, Alabama, 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, Richard J. Oparil,
ARNALL GOLDEN GREGORY LLP, Washington, D.C., Grant J. Guillot, GRANT GUILLOT,
LLC, Baton Rouge, Louisiana, Russell A. Newman, THE NEWMAN LAW FIRM, Brentwood,
Tennessee, Christopher Wiest, CHRIS WIEST, ATTORNEY AT LAW, PLLC, Crestview Hills,
Kentucky, James P. Sullivan, OFFICE OF THE GOVERNOR, Austin, Texas, Harmeet K.
Dhillon, Ronald D. Coleman, Mark P. Meuser, Michael A. Columbo, DHILLON LAW GROUP
INC., San Francisco, California, Robert Alt, THE BUCKEYE INSTITUTE, Columbus, Ohio,
Patrick Strawbridge, CONSOVOY MCCARTHY PLLC, Boston, Massachusetts, for Petitioners.
ON RESPONSE: Sarah E. Harrington, Michael S. Raab, Adam C. Jed, Brian J. Springer,
Martin Totaro, UNITED STATES DEPARTMENT OF JUSTICE, Washington, D.C., for
Respondents.
The En Banc Court of the Sixth Circuit Court of Appeals delivered an order. MOORE, J.
(pp. 4 5), delivered a separate opinion concurring in the denial of the petitions for initial hearing
en banc in which COLE, CLAY, WHITE, and DONALD, JJ., joined. SUTTON, C.J. (pp. 6 32),
in which KETHLEDGE, THAPAR, BUSH, LARSEN, NALBANDIAN, READLER, and
MURPHY, JJ., joined, and BUSH, J. (pp. 33 42), delivered separate opinions dissenting from
the denial of the petitions for initial hearing en banc.
_________________
ORDER
_________________
The court having received petitions for initial hearing en banc, and the petitions having
been circulated to all active judges of this court, and less than a majority of the active judges of
this court having voted in favor of initial hearing en banc,
IT IS ORDERED that the petitions be, and hereby are, DENIED.
App. 186
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Nos. 21-7000, et al. In re: MCP No. 165, Occupational Safety & Page 4
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
________________________________________________________________
CONCURRING IN THE DENIAL OF INITIAL HEARING EN BANC
________________________________________________________________
KAREN NELSON MOORE, Circuit Judge, concurring in the denial of initial hearing en
banc. This is an important case on an accelerated timeframe. And yet, many challengers
proposed initial hearing en banc, an often nprod cti e, al a s inefficient process. See Mitts
v. Bagley, 626 F.3d 366, 370 (6th Cir. 2010) (Sutton, J., concurring in denial of en banc review).
Because a three-judge panel of our court has already devoted significant time to this case, and
because initial hearing en banc would subvert our normal process and require the full court to
grapple with a sprawling record, I concur in the denial of initial hearing en banc.
Courts have repeatedly recognized that en banc hearing is an inefficient process. See
Mitts, supra; Hart v. Massanari, 266 F.3d 1155, 1172 & n.29 (9th Cir. 2001) (calling en banc
proceedings nwieldy and time-cons ming ) (internal q otation omitted); Bartlett ex rel.
Neumann v. Bowen, 824 F.2d 1240, 1243 (D.C. Cir. 1987) (Edwards, J., concurring in the denial
of rehearing en banc) (noting that en banc rehearing s bstantiall dela s the case being
reheard ). This potential for dela is magnified hen there has been no prior panel
consideration of a case. Belk v. Charlotte-Mecklenburg Bd. of Educ., 211 F.3d 853, 854 (4th
Cir. 2000) (Wilkinson, C.J., concurring in denial of initial hearing en banc).
This case shows the folly of initial hearing en banc. The massive docket and profusion of
briefs, as in an especially complex matter before a district court, require focused consideration by
a de oted panel. En banc hearing does indeed p t all hands on deck. C.J. S tton Dissent at
11. In a case as important, accelerated, and briefing-filled as this one, however, gathering all
hands on deck would have strained the resources of the sixteen active judges, requiring each of
us to review the volumino s record and the rele ant nderl ing legal doctrines. What s more, it
would have done so for no discernable purpose: the case already sits before three thoughtful,
independent judges on the panel who have spent the past weeks steeped in this matter.
We properly leave the matter in their hands.
App. 187
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Nos. 21-7000, et al. In re: MCP No. 165, Occupational Safety & Page 5
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
O r decisions arrant the tmost respect hen the are percei ed b the p blic to ha e
been reached in the most reg lar and caref l manner. Belk, 211 F.3d at 856 (Wilkinson, C.J.,
concurring in denial of initial hearing en banc). I am relieved that this court adheres to those
standards of regularity and care today.
App. 188
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Nos. 21-7000, et al. In re: MCP No. 165, Occupational Safety & Page 6
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
________________________________________________________________
DISSENTING FROM THE DENIAL OF INITIAL HEARING EN BANC
________________________________________________________________
SUTTON, Chief Judge, dissenting from the denial of initial hearing en banc. When
much is sought from a statute, much must be shown. The Secretary of Labor asks a lot of the
Occupational Safety and Health Act. He claims authority to issue an emergency rule, scheduled
to go into effect on January 4, 2022, that will require roughly 80 million workers to become
vaccinated or face a weekly self-financed testing requirement and a daily masking requirement.
At the same time, he assumes authority to regulate an area public health and safety
traditionally regulated by the States. If valid, the rule would nullify all contrary state and local
regulations, as the power to regulate nationally is the power to preempt locally. Such broad
assertions of administrative power demand unmistakable legislative support. The federal courts
e pect Congress to speak clearl hen a thori ing an agenc to e ercise po ers of ast
economic and political significance and to se e ceedingl clear lang age if it ishes to
significantl alter the balance bet een federal and state po er. A a. A f Rea . De
of Health & Hum. Servs., 141 S. Ct. 2485, 2489 (2021) (quotation omitted).
Congress did not clearl grant the Secretar of Labor a thorit to impose this
vaccinate-or-test mandate. First, as a threshold matter, the Occupational Safety and Health Act
gives the Secretary power to address only occupational health and safety risks. But it is by no
means clear that this authority extends to all hazards that might affect employees at some point
during the 16 hours of each weekday and the 48 hours of each weekend when they are not at
work, whether the hazard arises from a coronavirus of one sort or another, a virulent flu, traffic
safety, air pollution, vandalism, or some other risk to which people are equally exposed at work
and outside of work. It is one thing to tell a worker to don a mask at the start of a hazard-filled
shift and doff it at the end. It is quite another to tell a worker to vaccinate on the basis of a risk
that exists whether he is on the clock or off and that amounts to a medical procedure that cannot
be removed at the end of the shift. Confirming the point, the Secretary of Labor has never
imposed a vaccine mandate or for that matter a vaccinate-or-test mandate on American workers.
App. 189
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Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
The Act does not clearly give the Secretary power to regulate all health risks and all new health
hazards, largely through off-site medical procedures, so long as the individual goes to work and
may face the hazard in the course of the workday.
Second, even apart from the workplace-anchored scope of the Act, the Secretary of
Labor s po er to iss e emergenc temporar standards does not j stif the first accinate-or-
test mandate in federal labor law history. This emergency po er e tends onl to necessar
meas res, namel meas res indispensable or essential to address a gra e danger in the
workplace. But this set of preconditions does not apply (1) when the key population group at
risk from COVID-19 the elderly in the main no longer works, (2) when members of the
working-age population at risk the unvaccinated have chosen for themselves to accept the
risk and any risk is not grave for most individuals in the group, and (3) when the remaining
group the vaccinated does not face a gra e risk b the Secretar s o n admission, e en if
they work with unvaccinated individuals. Countless lesser and more focused measures were
available to the Secretary: targeting certain industries susceptible to high risk, focusing on
protections for workers most vulnerable to the virus, and varying any requirements to account for
the wide range of settings in which people work. A blunt national vaccine mandate for
80 million workers with little regard to the relevant employment circumstances well-spaced or
not, together or apart, high risk individuals or not, indoors or mainly outdoors was not
necessary under the Act, and Congress did not clearly say otherwise.
Third, the setting of these requirements a thorit to set emergenc temporar
standards itho t compl ing ith the notice-and-comment process confirms the narrowness
of this a thorit and its inapplicabilit here. Start ith emergenc . The Secretar does not
invoke this power based on a sudden revelation that the virus presents a serious health risk. How
could he? He relies on something else the increased availability of vaccines. That
development, however, does not heighten health risks; it alleviates them and it s hardl a ne
de elopment an a . What, moreo er, is temporar about a vaccination? A reluctant or
coerced vaccination cannot be undone if the Secretary changes course during the notice-and-
comment process or if the proposed r le e ceeds the Secretar s a thorit . All of the Secretar s
App. 190
Case: 21-7000 Document: 380-2 Filed: 12/15/2021 Page: 8
Nos. 21-7000, et al. In re: MCP No. 165, Occupational Safety & Page 8
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
emergency decrees to date, even the ones invalidated by the courts, have involved truly
temporary measures to protect workers from certain hazards at work until the notice-and-
comment process ends. Ready access to free vaccinations may not have quelled the pandemic as
quickly as the Secretary, or any of us, would like. But that reality does not justify, much less
justify clearly, a sudden invocation of an emergency medical power at roughly the two-year
anniversary of the pandemic merely because the Secretary determines that not enough Americans
are vaccinated.
For m part, the resol tion of this conflict bet een e isting la and the Secretar s
proposed policy is not particularly hard. What makes the case difficult are the ongoing
challenges of the pandemic and the health-and-safety benefits of obtaining vaccinations. The
challenges presented by the pandemic are serious, no one can deny. The record confirms what
common experience shows that the p blic has a strong interest in combating the spread of a
virus that has prematurely ended over three-quarters of a million American lives. A a. A f
Realtors, 141 S. Ct. at 2490. The record also shows the utility of vaccinations. The medical
studies to date show that vaccinated individuals face fewer risks of getting the virus and, for
those who still suffer breakthrough infections, fewer risks of serious symptoms or death. It is the
rare federal judge, indeed the rare employee in the third branch, I suspect, who has not gotten the
message.
But the issue here is not that simple. No matter the policy benefits of a well-intended
reg lation, a co rt ma not enforce it if the agenc s reach e ceeds a stat te s grasp. Once
before, in the throes of another threat to the country, the executive branch claimed it needed to
seize control of the co ntr s steel mills as a necessar meas re to a ert a national
catastrophe. Youngstown Sheet & Tube Co. v. Sawyer, 343 U.S. 579, 582 (1952). But that
threat, like this one, did not permit the second branch to act without authorization from the first
branch. Id. at 588 89. As the Supreme Court recently explained in invalidating an eviction
moratori m prom lgated b the Center for Disease Control, o r s stem does not permit
agencies to act nla f ll e en in p rs it of desirable ends. A a. A n of Realtors, 141 S. Ct.
at 2490. Shortcuts in furthering preferred policies, even urgent policies, rarely end well, and
App. 191
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Nos. 21-7000, et al. In re: MCP No. 165, Occupational Safety & Page 9
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
they always undermine, sometimes permanently, American vertical and horizontal separation of
powers, the true mettle of the U.S. Constitution, the true long-term guardian of liberty.
For these reasons and those elaborated below, the challengers are likely to prevail on the
merits when it comes to their petitions targeting the emergency rule. That reality together with
the other stay factors show that the emergency rule should remain stayed. Nken v. Holder,
556 U.S. 418, 434 (2009); A a. A f Rea , 141 S. Ct. at 2490.
I.
Congress passed the Occupational Safety and Health Act in 1970. Pub. L. No. 91-596,
84 Stat. 1590. With the Act, Congress created an agency to administer the statute the
Occupational Safety and Health Administration, called OSHA for short which sits within the
Department of Labor. From the o tset, the Act as designed to ens re safe and healthf l
working conditions for emplo ees. 29 U.S.C. 651(b). The Act empowers the Secretary of
Labor, through OSHA, to create health and safety regulations for workplaces across the country.
Id. § 655(b). Before such regulations go into effect, they must withstand a rigorous process. The
Secretary must provide notice of any proposed regulation and give 30 days for any affected
entity to submit data or offer comment about the costs, benefits, feasibility, legality, or any other
reason for rejecting, adopting, or modifying the proposed rule. Id. § 655(b)(2). Those who
object to the rule may request a public hearing. Id. § 655(b)(3). Within 60 days of the end of the
period for submitting comments or the completion of a requested hearing, the Secretary must
publish a rule or decide not to issue one. Id. § 655(b)(4). Still more process is called for if the
proposed rule involves, as this one allegedly does, to ic materials or harmf l ph sical agents,
in hich case its de elopment m st be based pon research, demonstrations, e periments, and
s ch other information as ma be appropriate. Id. § 655(b)(5).
An exception exists. The Act allows the Secretary to create an emergenc temporar
standard itho t ndergoing all of these notice-and-comment requirements. Id. § 655(c). To
allo an emergenc reg lation to go into immediate effect, the Secretar m st sho (1) that
emplo ees are e posed to gra e danger from exposure to substances or agents determined to be
App. 192
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Nos. 21-7000, et al. In re: MCP No. 165, Occupational Safety & Page 10
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
to ic or ph sicall harmf l or from ne ha ards, and (2) that the emergenc standard is
necessar to protect emplo ees from s ch danger. Id. § 655(c)(1).
Since 1970, the Secretary of Labor has used these emergency powers infrequently and
never to require a medical procedure. Over more than a half-century, the agency has used this
power just nine times before this year. BST Holdings, L.L.C. v. Occupational Safety & Health
Admin., 17 F.4th 604, 609 (5th Cir. 2021). Six of these standards were challenged in court. Id.
Just one was allowed to go into effect. Id.; see also 79 Fed. Reg. 61,384, 61,419 (Oct. 10, 2014)
(noting that OSHA has not s ccessf ll adopted an emergenc temporar standard for over
thirt ears ). In a more recent exercise of this power, which a court has not yet addressed, the
Secretary issued an emergency regulation in June 2021, which imposed requirements on the
healthcare industry to reduce transmission of COVID-19, mainly protective clothing and
physical distancing. 86 Fed. Reg. 32,376 (June 21, 2021). The emergency rule did not require
workers to get vaccinated or subject themselves to uncompensated weekly tests.
At iss e is OSHA s No ember 5 emergenc standard, entitled COVID-19 Vaccination
and Testing; Emergenc Temporar Standard. 86 Fed. Reg. 61,402 (No . 5, 2021). It applies
to employers with 100 or more employees, what comes to roughly 80 million employees
nationwide. Id. at 61,467. And it contains a narro e emption for emplo ees ho ork[]
remotel 100 percent of the time or ho perform their ork e cl si el o tdoors. Id. at
61,419, 61,467.
The emergency rule also applies to the 26 States in the country that administer their own
state OSHA Plans, which means that those States must enforce the vaccinate-or-test mandate
against any covered public employees and private businesses in their jurisdiction. Id. at 61,462.
Although Congress did not require state and local governments to adhere to the Act, see
29 U.S.C. §§ 652(5), 654(a)(2), it used its spending power to encourage States to accept federal
funding up to 50% of the total cost of each state plan in return for adopting an
OSHA-approved state plan, id. § 672(g). Under the Act, state plans must be at least as effective
as the federal standards required by the Secretary. Id. § 667(b), (c)(2).
App. 193
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Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
Under the emergenc r le, the emplo er m st erif the accination stat s of each
emplo ee, maintain a record of each emplo ee s accination stat s, and preser e acceptable
proof of accination. 86 Fed. Reg. at 61,552. For emplo ees ho opt not to get accinated, the
employer must require a test every seven days, one that neither the Federal Government nor the
employers 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
compl m st be remo ed from the orkplace. 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).
Several companies, organizations, individuals, and 27 States filed challenges to the
emergency rule, raising a variety of claims in the various courts of appeals. On November 12, in
one of those cases, the U.S. Court of Appeals for the Fifth Circuit stayed the vaccinate-or-test
mandate. BST Holdings, 17 F.4th at 619. After our circuit was selected to handle the petitions
for review on a consolidated basis, we received two sets of pertinent motions: a motion by the
Secretar of Labor to acate the Fifth Circ it s sta order, see 28 U.S.C. § 2112(a)(4), and
requests by various parties to grant initial hearing en banc.
II.
A few words are in order about the en banc motions in front of us requests by roughly
59 parties that the full Court hear this case at the outset. At one level, granting the motion makes
considerable sense. This is an extraordinary case, suitable for an extraordinary procedure.
Given the unusual setting of these consolidated cases a statutory delegation of authority over
countless appeals to one regional court of appeals, 28 U.S.C. § 2112(a) there is something to be
said for putting all hands on deck, particularly when it comes to handling the stay motion, which
could turn out to be the key decision point in all of these petitions for review. If the stay motion
is the main event in a case about the legitimacy of a six-month emergency rule that ends on May
5, 2022, little opportunity for traditional en banc review will exist at the back end of the case.
App. 194
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All of this explains why we favor granting the motion. But at another level, it makes little
difference that our Court has divided 8-8 on whether to grant the en banc motion. We likely will
not be the final decisionmakers in this case, given the prospect of review by the U.S. Supreme
Court. And the existence of the en banc motion gives the judges of our Court the option to offer
their perspectives on the stay motion, in opinions concurring in the denial of initial hearing en
banc or dissenting from it.
III.
In evaluating a stay motion, we ask four questions: Which side is likely to prevail on the
merits? What are the costs to the challengers of allowing the emergency rule to go into effect?
What are the costs to the Secretary of Labor and others of barring the emergency rule from going
into effect? What does the public interest favor? Nken, 556 U.S. at 434. In this instance, as in
many others, we focus primarily on the likelihood-of-success inquiry. See A a. A f
Realtors, 141 S. Ct. at 2490.
IV.
The challengers should prevail for two main reasons. A clear-statement rule applies to
this wide-ranging and unprecedented assertion of administrative power, and the Secretary of
Labor has failed to show that Congress clearly delegated this authority to him.
A.
Toda s emergenc r le is not an e er da e ercise of federal po er. The Secretar
claims authority to require 80 million Americans in virtually every type of American business
there is to obtain a COVID-19 vaccine or, in the alternative, to undertake a weekly COVID-19
test and wear a mask throughout each workday. Because the Federal Government pays for the
vaccine but not the weekly test, it is fair to say that the Secretary is prioritizing the vaccine
mandate over the test-and-mask mandate, if not coercing vaccinations. See 86 Fed. Reg. at
61,434 (ackno ledging that the emergenc r le is designed to strongl enco rage
accination ). F rther press re on emplo ees comes from other feat res of the r le:
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(1) Employers must provide time off for employees to get vaccinated and to recover from any
side effects, id. at 61,457, while the rule does not require them to do so for employees who must
undergo weekly tests, even if that requires considerable travel in rural areas, see id. at 61,484;
(2) the agency normally requires employers to compensate employees for occupational safety
gear and required testing but not in this instance, compare 29 C.F.R. § 1910.132(h), with 86 Fed.
Reg. at 61,407 & n.2; and (3) employers can escape many of the administrative burdens of
administering the rule if they require their employees to get vaccinated, 86 Fed. Reg. at 61,437.
Either way, whether treated as a vaccine mandate or a vaccinate-or-test mandate, the Secretary
must answer mandates of his own if he wishes to regulate large swaths of Americans with
respect to substantial public policy, medical, and economic matters customarily regulated by the
States.
In the first place, the federal co rts e pect Congress to speak clearl hen a thori ing
an agency to exercise po ers o er large n mbers of Americans ith respect to contested p blic
policy choices of vast significance. A a. A f Rea , 141 S. Ct. at 2489. Skeptical of
mismatches between invocations of power by agencies and the statutes that purport to delegate
that power, the federal courts require broad assertions of policymaking authority to be premised
on direct and specific congressional delegations of that po er. Congress m st speak clearl 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) (quotation omitted); see Whitman v. Am. Trucking
A , 531 U.S. 457, 468 (2001). What J stice Ste ens said in 1980 in rejecting the Ben ene
r le, designed by OSHA to protect American workers from cancer, applies with equal force to
toda s r le: In the absence of a clear mandate in the Act, it is nreasonable to ass me that
Congress intended to give the Secretary the unprecedented power over American industry that
o ld res lt from the Go ernment s ie of the stat te. I d . U De , AFL-CIO v. Am.
Petroleum Inst., 448 U.S. 607, 645 (1980) (plurality opinion). Notably, OSHA initially
attempted to issue the Benzene Rule as an emergency rule, but it abandoned that approach in
favor of notice-and-comment rulemaking after the Fifth Circuit stayed the rule. Id. at 623.
App. 196
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A national vaccinate-or-test mandate likewise is unprecedented, whether with respect to
OSHA or any other federal agency, presumably because the intrusion on individual liberty is
serio s and beca se, in OSHA s case, the req ired medical proced res do not comfortabl map
onto workplace-specific protective remedies. See Cong. Rsch. Serv., Mandatory Vaccinations:
Precedent and Current Laws 9 (May 21, 2014); see also 86 Fed. Reg. at 61,436. If OSHA
claims to disco er in a long-extant statute an unheralded power to regulate a significant portion
of the American econom , it sho ld not be s rprised if co rts greet its anno ncement ith a
meas re of skepticism. Util. Air Regul. Grp., 573 U.S. at 324 (quotation omitted). As with the
eviction moratorium created by the federal Center for Disease Control and invalidated by the
S preme Co rt, toda s claim of e pansi e a thorit nder this pro ision is nprecedented.
A a. A f Rea , 141 S. Ct. at 2489; ee T ge L , LLC . U.S. De fH . & U b.
Dev., 5 F.4th 666, 668 (6th Cir. 2021). If federal courts have been skeptical when a medically
based agency (the CDC) issues broad mandates with respect to housing, they should be equally
skeptical when a workplace agency (OSHA) issues broad mandates with respect to medical
procedures.
In the second place, the States, not the Federal Government, are the traditional source of
authority over safety, health, and public welfare. In the context of a vast attempt to assume these
police powers by the Federal Government, Congress must speak unequivocally. Whether it is
sei ing a thorit to reg late the landlord-tenant relationship, A a. A of Realtors, 141 S. Ct.
at 2489, to regulate private property, U.S. F e Se . . C a e R e Pe. A ,
140 S. Ct. 1837, 1849 50 (2020), to enact run-of-the-mine criminal laws, Jones v. United States,
529 U.S. 848, 858 (2000), to enact out-of-the-ordinary criminal laws, Bond v. United States,
572 U.S. 844, 848 (2014), or to regulate the retirement age of state court judges, Gregory v.
Ashcroft, 501 U.S. 452, 460 61 (1991), Congress m st enact e ceedingl clear lang age if it
wishes to significantl alter the balance bet een federal and state po er, A a. A f Rea ,
141 S. Ct. at 2489 (quotation omitted).
In applying this federalism clear-statement canon, it s orth remembering that the onl
Supreme Court cases that permitted a government to impose a vaccination mandate on
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individuals arose from the States, not the National Government. Jacobson v. Massachusetts,
197 U.S. 11 (1905); Zucht v. King, 260 U.S. 174 (1922). In upholding a vaccination requirement
against a substantive due process challenge, the U.S. S preme Co rt reasoned that [t]he safet
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 ordinaril concern the national go ernment. Jacobson,
197 U.S. at 38. It s orth remembering that the po er of a federal agenc to reg late is the
power to preempt to nullify the sovereign power of the States in the area which explains why
27 States oppose the emergenc r le. And it s orth remembering that, if one casually accepts
congressional authority to regulate in this area, that recalibration of power comes with easy-to-
overlook risks. It would mean that another administration could destroy the trial-and-error
benefits of federalism in a different direction, say by adopting a federal law that banned state and
local governments from issuing all kinds of health-protective orders: stay-at-home orders, mask
mandates, vaccine mandates, and many other measures besides. The power to give with
preemptive national regulation includes the power to take away.
B.
In passing the Occupational Safety and Health Act, Congress did not clearly give the
Secretary authority to require workers to undertake a medical procedure like a vaccine or a
medical test, whether under his general a thorit to reg late emplo ees in the orkplace or
nder his specific a thorit to iss e emergenc temporar standards.
1.
The Occupational Safety and Health Act covers only workplace-specific hazards and
permits only workplace-specific safety measures. As a threshold matter, the Act is designed to
protect emplo ees from dangers that arise directl o t of the orkplace and addresses only
orkplace conditions, as the title of the Act s ggests (the Occ pational Safet and Health Act )
and as the rest of the Act confirms. The language of the Act covers dangers arising out of work,
say a chemical used to make a plastic product or the heat generated at a steel foundry, not any
risk facing the country and every citizen in it. Any other approach would facilitate a
App. 198
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breathtaking e pansion of the Secretar of Labor s po er. Whate er the health and safet
challenges of today (air pollution, violent crime, obesity, a virulent flu, all manner of
communicable diseases) or tomorrow (the impact of using the internet on mental health), the
Secretary does not have emergency authority to regulate them all simply because most
Americans who face such endemic risks also have jobs and simply because they face those same
risks on the clock. By going to work each day, American workers do not transform these other
risks into ha ards or gra e dangers to hich emplo ees are e posed. The Secretar s
authority to regulate workplace safety is simply too indirect[] to cover this nearly horizonless
assertion of power. A a. A f Rea , 141 S. Ct. at 2488.
A comparison bet een the Secretar s emergenc proposal (a accinate-or-test mandate)
and the kinds of requirements he has previously imposed on various industries during the
pandemic (a mask mandate) illustrates the problem. Accept for now that, under some
circumstances and in some places, the Secretary could impose a mask mandate. That would be a
workplace requirement at least. It is one thing for the Secretary to require masks to minimize
dangers to hich emplo ees are e posed d ring the orkda and at the orkplace. It is q ite
another to make an across-the-board judgment that the employee is strongl enco raged
emphasis on strongly to undertake a medical procedure (a vaccination) that cannot be undone
at the end of the workday.
Whether it s the Act as a hole or the narro e ception for emergenc r lemaking, the
both apply, in the words of the D.C. Circ it, onl to dangers arising o t of ork or ork-related
acti ities, O , C e . & A cW e I U .A .C a a d C ., 741 F.2d 444, 449
(D.C. Cir. 1984), not all hazards working people may face in their daily lives. That explains why
the D.C. Circuit found another medical procedure the sterilization of women who otherwise
would encounter chemicals at work dangerous to the unborn to be be ond the Act s scope. Id.;
see also Steel Joist Inst. v. Occupational Safety & Health Admin., 287 F.3d 1165, 1167 (D.C.
Cir. 2002) (noting that the Act a thori es OSHA to reg late onl the emplo er s cond ct at the
orksite ). [F]or co erage nder the Act to be properl e tended to a partic lar area, seconds
the Ele enth Circ it, the conditions to be regulated must fairly be considered working
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conditions, the safety and health hazards to be remedied occupational, and the injuries to be
avoided work-related. Fa De Fa . Sec f Lab., 696 F.2d 1325, 1332 (11th Cir.
1983).
Other provisions of the Occupational Safety and Health Act reinforce the message. The
Act, it is tr e, refers to ha ards, s bstances, and agents, terms that read in isolation might
suggest that the Secretary could regulate any hazardous substance or agent. But context
illuminates meaning. Throughout the Act, it speaks to hazards facing employees in work-
specific contexts and to occupational risks faced due to work:
x The Act s preamble sa s it is designed to ass re . . . safe and healthful
working conditions, 29 U.S.C. 651(b), and to a oid personal inj ries and
illnesses arising o t of ork sit ations, id. § 651(a).
x A pro ision sa s that the Act applies to emplo ment performed in a
orkplace and to orking conditions of emplo ees. Id. § 653(a), (b).
x A pro ision tells the Secretar to make r les for de eloping information
regarding the ca ses and pre ention of occ pational accidents and illnesses,
id. § 657(c)(1), or ork-related deaths, inj ries and illnesses, id.
§ 657(c)(2).
The agenc s reg lations reflect this nderstanding too. In general, OSHA req ires
employers to compensate employees for protective gear and tests needed for work safety.
29 C.F.R. § 1910.132(h). An exception exists for costs that are not specific to the workplace, say
sunscreen or steel-reinforced boots. Id. § 1910.132(h)(2), (4)(iii). In this instance, the
Secretar s decision not to req ire emplo ers to pa for emplo ees eekl COVID-19 tests
depletes his claim that this emergency rule arises from a work-focused, as opposed to society-
focused, imperative. See 86 Fed. Reg. at 61,437. The Secretary conceded that, while OSHA
s all req ires emplo ers to bear s ch costs in order to remo e barriers to emplo ee
participation, the agenc has not done so here in order to strongl enco rage accination. Id.
at 61,407.
OSHA also requires employers to give their employees and the agency access to
rele ant e pos re and medical records to identif , handle, and pre ent occ pational disease.
29 C.F.R. § 1910.1020(a). The agenc req ires emplo ers to keep records that monitor[] the
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amount of a toxic substance or harmful physical agent to which the employee is or has been
e posed. Id. § 1910.1020(e)(2)(i)(A)(1). B t these e pos re risks do not co er sit ations
where the employer can demonstrate that the toxic substance or harmful physical agent is not
used, handled, stored, generated, or present in the workplace in any manner different from
typical non-occ pational sit ations. Id. § 1910.1020(c)(8). As still another example, the
agency has rules about occupational noise exposure, which require employers with affected
emplo ees to administer a testing program that determines the emplo ee s hearing loss. Id.
§ 1910.95(g). If the hearing loss is determined not to be ork related, ho e er, the emplo er
does not have to provide assistance. Id. § 1910.95(g)(8). With respect to the recordkeeping
req irements, moreo er, an emplo er m st consider an inj r or illness to be ork-related if an
event or exposure in the work environment either caused or contributed to the resulting condition
or significantly aggravated a pre-e isting inj r or illness. Id. § 1904.5(a). In OSHA s r les
concerning air contaminants, the r les center on the amo nt of an emplo ee s e posure to a
s bstance d ring an 8-ho r shift. Id. § 1910.1000(a) (c).
The agency in the past has understood its authority in this work-anchored way. An
e amination of the nine emergenc temporar standards prom lgated before 2021, e en the
five of six that were successfully challenged, reveals only regulations addressing exposures
solely because of, not in spite of or in addition to, the workplace. See 36 Fed. Reg. 23,207 (Dec.
7, 1971) (workplace protection from asbestos); 38 Fed. Reg. 17,214 (June 29, 1973) (workplace
protection from pesticides); 38 Fed. Reg. 10,929 (May 3, 1973) (workplace protection from
carcinogenic s bstances in area[s] to hich access is restricted and controlled b the
emplo er ); 39 Fed. Reg. 12,342 (Apr. 5, 1974) (workplace protection from vinyl chloride);
41 Fed. Reg. 24,272 (June 15, 1976) (workplace protections for diving operations, while noting
that di ing b persons engaged in recreational or sport di ing or other di ing not in an
employment context are beyond the jurisdiction of the Act ); 42 Fed. Reg. 22,516 (Ma 3, 1977)
(workplace protections from benzene); 42 Fed. Reg. 45,536 (Sept. 9, 1977) (workplace
protection from manufacturing pesticides); 43 Fed. Reg. 2586 (Jan. 17, 1978) (workplace
protection from acrylonitrile); 48 Fed. Reg. 51,086 (Nov. 4, 1983) (workplace protection from
asbestos).
App. 201
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All in all, the Secretary might have authority to impose mandates of some sort on doctors
and nurses who treat COVID-19 patients or researchers who work with the underlying virus
gi en the orkplace e pos re risks ca sed b that ork. And it might gi e the Secretar
authority to impose workday masking requirements in other settings vulnerable to COVID-19
exposures. But the emergency rule extends well beyond such workplace-specific hazards and
workplace-specific remedies.
2.
Not only is it doubtful that Congress gave the Secretary of Labor clear authority to
impose this vaccinate-or-test mandate through the general provisions of the Act, but Congress
also failed to do so clearl nder the pro ision for emergenc temporar standards. In rele ant
part, the provision for emergency rules says:
The Secretary shall provide, without regard to the requirements of chapter 5 of
Title 5, for an emergency temporary standard to take immediate effect upon
publication in the Federal Register if he 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).
T e a e a e ece a a add e ga e ace
dangers. The term necessar has one of t o meanings, either sef l or
indispensable / essential. B ac La Dc a 928 (5th ed. 1979); American Heritage
Dictionary of the English Language 877 (1975). Picking between the options might be difficult
if the word appeared alone. But it does not. It appears in the context of a provision dealing with
an emergenc and gra e danger. Understanding ords, like filling in cross ord p les,
works best by attending to context what is nearby, what is known. Gutierrez v. Ada, 528 U.S.
250, 255 (2000). Once connected, the reference to necessar po ers to address gra e
dangers in an emergenc clarifies that necessar has the narro er meaning. It refers onl to
indispensable or essential measures, not to whatever the Secretary determines is useful or
beneficial.
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A comparison to the Secretar s a thorit to impose permanent standards confirms this
reading. When he p ts a r le thro gh notice and comment, the standard need not be necessar
to protect emplo ees, 29 U.S.C. 655(c)(1), onl reasonabl necessar or appropriate to
provide safe or healthf l emplo ment, id. § 652(8); see id. § 655(b). An emergency measure
thus must be more than just appropriate; it must be indispensable or essential.
T rn to gra e dangers, hich refer to serio s orkplace dangers. Web e N
New Collegiate Dictionary 534 (1984). Taken by itself, there is room for debate about the
meaning of a serious workplace danger, particularly one that the statute allows the Secretary to
determine[] himself. B t the record in this case and the Secretar s position in describing his
rulemaking narrow the range of debate. Whatever a grave or serious workplace danger might
mean in the abstract, the Secretary concedes that vaccinated individuals who get the virus do not
face that risk, even though they can contract it while going to work with unvaccinated
individuals. 86 Fed. Reg. at 61,434. Else, the Secretary would require vaccinated Americans to
work at home or stay home altogether.
This interpretation of the stat te and the Secretar s concession make it exceedingly
difficult to maintain under any standard of review that the emergency mandate is necessary or
indispensable to address a grave danger. One problem arises from a core tenet of administrative
law. The Secretary never considered this meaning of the statute that it requires indispensable
or essential measures, not simply useful or beneficial ones in proposing the emergency rule. It
is a staple of administrative law that federal courts may not uphold a rule on a ground never
addressed by the agency. SEC v. Chenery Corp., 318 U.S. 80, 87 (1943). The Secretary to date
has explained only why he thinks the vaccinate-or-test mandate is beneficial to protect workers
and society as a whole. He has not explained why it is the indispensable or essential way to
protect orkers. We ha e no a thorit to phold a r le as necessar hen the Secretar has
not made that finding himself under the correct interpretation of the law. See 5 U.S.C. § 706(2).
The other problem is that the Secretary cannot satisfy this interpretation of the statute.
Consider the many less intrusive, more tailored protective measures that address grave dangers
on the Secretar s o n terms. J st as the Secretar targeted the healthcare ind str in J ne 2021
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with mask and other protective-gear requirements, he could do the same for industries that face
high spreading risks. The record does not show that full vaccination or weekly testing is
necessary on top of a tailored mask mandate. The Secretary could focus any requirements on the
workers most at risk those over 65, those with pre-existing conditions most vulnerable to the
virus, those who have not already gotten the virus. The Secretary could create exemptions for
those least at risk, say cohorts from age 18 to 49, a population range that faces healthcare risks
from COVID-19 at ro ghl the same le el as the Secretar s o n assessment of hat is not a
grave risk, with some slightly above and some slightly below. See 86 Fed. Reg. at 61,434; Ctr.
for Disease Control, Rates of COVID-19 Cases and Deaths by Vaccination Status,
https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status. Or the Secretary could impose
requirements that account for the many environments in which Americans work. Consider the
range of possibilities from the two-person janitorial staff working the night shift, to the
consultant who comes into the office a few times a week, to the company that already requires
masks (but not weekly tests) and requires significant separation of workers protected by up-to-
date ventilation systems, to the firm that rotates workers between telework and in-person to
minimi e contact. B t that is not hat the r le does. Appl ing to 2 o t of 3 pri ate-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 emplo ees. BST Holdings, 17 F.4th at 615.
In the face of the many less intrusive options available to the Secretary, the idea that a
national vaccinate-or-test mandate for 80 million workers is necessary is hard to maintain. And
that is true under any standard of review: fresh review of the language of the statute, substantial
evidence review, arbitrary or capricio s re ie , or the harder look re ie d e emergenc
rules. A be I f .A . Occ a a Safe & Hea Ad ., 727 F.2d 415, 421 (5th Cir.
1984).
T e a e c e a e e ge c a d e a e e e . In
construing statutes, courts frequently look to the context in which they arise here authority to
set emergenc temporar standards that sidestep the notice-and-comment process. See, e.g.,
App. 204
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Bond, 572 U.S. at 861 63; Johnson v. United States, 559 U.S. 133, 139 40 (2010). Whether one
looks to the Secretar s strongl enco raged preference ( accinate) or disco raged alternati e
(test and ear a mask), it is diffic lt to nderstand ho on No ember 5, 2021, an emergenc
suddenly took hold requiring the imposition of a vaccinate-or-test mandate by January 4, 2022.
Start with the mask requirement. As the Secretary well knows, masks are not a new idea. They
have been a protective tool from the outset. Given the wide availability of this option since the
beginning, the ie that this req irement co nts as an emergenc meas re, all at a time hen
fewer people face lethal risks from COVID-19, sucks the concept dry of meaning.
Vaccines are newer, to be sure. But they hardly are a revelation. They have been readily
available since last spring, and they alleviate the health risks from the pandemic rather than make
them worse. Why now? Why above all immediately impose such a controversial mandate on 80
million workers without undergoing the give and take that comes with the notice-and-comment
process and that usually leads to better rulemaking and always leads to more transparency
about the costs and benefits of any new rule for workers and companies. See Azar v. Allina
Health Servs., 139 S. Ct. 1804, 1816 (2019). The more e pansi e a r le s reach, the greater
the necessit for p blic comment. A . Fed fG E . . B c , 655 F.2d 1153, 1156
(D.C. Cir. 1981).
Ho , moreo er, is a accine temporar ? That approach con e s considerable
insensitivity to those who, for reasons of their own, are reluctant to roll up their sleeves. By any
measure, a vaccine injection is not temporary.
Making the invocation of this emergency temporary power odder still is the nature of the
risks presented by COVID-19 today. It is not working men and women in the main who face the
most serious risks. It is older men and women, most of whom are retired and who no longer are
s bject to the Secretar s o ersight. The ke risks to indi id als ho do ork and ho remain
unvaccinated are to them, not to their vaccinated colleagues. Sure, there have been, and likely
will continue to be, breakthrough cases that infect vaccinated individuals, some no doubt
facilitated by unvaccinated individuals. But the Secretary agrees that this risk is not serious.
During the rulemaking process, he acknowledged that the risk to vaccinated employees of
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contin ing to ork ith n accinated emplo ees is not a gra e danger. 86 Fed. Reg. at
61,434.
That leaves the Secretary with the burden of answering this question: Is it really an
emergency to protect retired individuals from a workplace they no longer visit, to protect
vaccinated working people from a risk the Secretary does not consider grave, and to protect
unvaccinated working people from themselves based on highly personal medical decisions?
That is a heavy lift, one that is highly unlikely to withstand any standard of review.
Eq all na ailing is the Secretar s other e planation for the emergenc r le.
Education, public-health advocacy, and easy-to-obtain free vaccinations, he points out, have not
worked as well as or as quickly as the Federal Government hoped because just 70% or so of
Americans have received one shot and just 60% or so of Americans are fully vaccinated. Ctr. for
Disease Control, COVID-19 Vaccinations in the United States, https://covid.cdc.gov/covid-data-
tracker/#vaccinations_vacc-total-admin-rate-total; see 86 Fed. Reg. at 61,431 32. The Secretary
projects that the strongl enco rage[d] accination option would lead an additional
22.7 million workers to get vaccinated, increasing the vaccination rate in the covered workforce
from 62% to 89%. 86 Fed. Reg. at 61,433, 61,472. These estimates as an initial matter lift the
eil on the Secretar s nderstanding of the rule, revealing that he thinks it will operate much
more like a vaccine mandate than a vaccine option. Another problem lurks as well. In the
context of new viruses, new variants, and other challenges presented by communicable diseases,
there will always be a spectrum of medical developments and innovations, whether it is new
types of vaccinations, booster shots, medical treatments, or something else. That ongoing reality
does not give one national agency the option of labeling something an emergenc in
perpetuity, immediately imposing a one-size-fits-all-companies solution on the country,
preempting all contrary approaches to the matter in our States and cities, and circumventing the
notice-and-comment process. In case of emergenc break glass this is not unless we wish to
sideline the notice-and-comment process and the trial-and-error benefits of American federalism
with respect to every future medical innovation concerning COVID-19 for this federal agency
and other ones too.
App. 206
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One last point on this score. The statute gives the Secretary authority to issue an
emergency rule only for six months. 29 U.S.C. § 655(c)(2) (3). It does not mention any
authority to extend the rule for another six months. To our knowledge, the Secretary has never
used this narrow authority to extend an emergency rule for another six months. All of this
prompts a question: Does the Secretary expect to finish the notice-and-comment process with
respect to this uniquely important and uniquely wide-ranging rule by May 5, 2022, when the
emergency rule dissolves? That seems improbable. As our circuit has come to appreciate, this
rule affects a lot of industries and a lot of people. Consistent with that reality, the Secretary has
already granted one 45-day extension of time, extending the end of the public comment period
from December 6, 2021, to mid-January 2022. The six-month nat re of the Secretar s
emergency-rule authority highlights the unusual nature of its exercise today.
In view of this conclusion, we need not address several serious constitutional claims
raised by the challengers. Among others, there are at least these three that would need to be
addressed before the emergency rule could be enforced. One, does this regulation of non-
commercial inactivity a requirement that the unvaccinated get shots or weekly tests exceed
Congress s Commerce Cla se po er? See Na Fed. f I d. B . . Sebe , 567 U.S. 519,
550 52 (2012); infra at 33 (Bush, J., dissenting); BST Holdings, 17 F.4th at 619 (Duncan, J.,
conc rring). T o, if e accepted the Secretar s s eeping reading of the Act permitting him
to regulate any substance, whether unique to work or not, so long as the Secretary finds it
dangerous would that amount to an unconstitutional delegation of power? See Gundy v. United
States, 139 S. Ct. 2116, 2123 (2019); id. at 2135 37 (Gorsuch, J., dissenting). Compare Indus.
U De , 448 U.S. at 645 (plurality opinion) (avoiding this constitutional question by
constr ing the stat te to narro OSHA s a thority), with id. at 687 (Rehnquist, J., concurring in
the j dgment) (finding an nconstit tional delegation beca se [i]t is diffic lt to imagine a more
obvious example of Congress simply avoiding a choice which was both fundamental for
purposes of the statute and yet politically so divisive that the necessary decision or compromise
as diffic lt, if not impossible ). Three, does compelling faith-sensitive employers to
administer these mandates violate the Free Exercise Clause or the Religious Freedom Restoration
Act by interfering with their employment decisions or religious mission? See Burwell v. Hobby
App. 207
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Lobby Stores, Inc., 573 U.S. 682, 719 20 (2014); Our Lady of Guadalupe Sch. v. Morrissey-
Berru, 140 S. Ct. 2049, 2060 61 (2020). Because our interpretation of the relevant statutes
avoids these constitutional claims and any others, we need not address them. See United States
v. Erpenbeck, 682 F.3d 472, 476 (6th Cir. 2012). By contrast, anyone who takes the view that
the Fifth Circ it s sta sho ld be lifted must come to grips with each of the statutory imperatives,
each of the clear statement requirements, and all of the constitutional claims.
C.
The Secretary insists that any ambiguity in the statute favors him, not the challengers. He
claims that uncertainty about the meaning of the statute allows him to construe the statute to
exercise more power, not less. Resp. Mot. to Dissolve Stay at 17; Chevron, U.S.A., Inc. v. Nat.
Res. Def. Council, 467 U.S. 837, 843 44 (1984). But ambiguity for Chevron purposes comes at
the end of the interpretation process, not at the beginning. Id. at 843 n.9. The clear-statement
canons eliminate any power-enhancing uncertainty in the meaning of the statute. With
significant constit tional and federalism q estions raised and a federalism-protecting
interpretation of the stat te not clearl r led o t, e m st accept that interpretation and reject
the req est for administrati e deference. Solid Waste Agency of N. Cook Cnty. v. U.S. Army
C fE g , 531 U.S. 159, 174 (2001).
A contrary approach leads to a characterization of administrative law under which
significant decisions of the U.S. Supreme Court were one emergency regulation, no notice, no
comment, away from oblivion, indeed from effectively being overruled. If the Secretary is right,
the federal office of civil rights suddenly could have construed the ambiguity in the ADEA to
cover state court judges. Cf. Gregory, 501 U.S. at 460 61. If true, the Department of the
Interior suddenly could have construed the ambiguity in the Mineral Leasing Act and National
Trails System Act to regulate all manner of private property. Cf. C a eR e P e .A ,
140 S. Ct. at 1848 50. If true, the SEC suddenly could have construed the Securities and
Exchange Act to apply outside the United States. Cf. M . Na A . Ba L d., 561
U.S. 247, 272 73 (2010). And so on. Chevron has no role to play in this case.
App. 208
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The Secretary counters that he is entitled to issue an emergency rule given new
knowledge about the dangers of COVID-19 and the increased risk of infection and transmission
d e to the Delta ariant. B t the Delta ariant has dominated o r co ntr s COVID-19 statistics
since June. See 86 Fed. Reg. at 61,408 09. Even then, the Secretary found that vaccinated
orkers do not face a gra e danger from COVID-19, with or without the existence of Delta.
Id. at 61,434.
The Secretary emphasizes that he is regulating the workplace because the virus creates
risks for working men and women. But authority to regulate the workplace with protective gear
designed to handle on-the-job exposures to substances and tailored to the circumstances of that
job is one thing; authority to require medical procedures or tests for two-thirds of American
workers, no matter their work circumstances or individual risks, is quite another. This is
precisely the kind of broad assertion of administrative power that should be accompanied by
clear, direct, and channeled delegations by Congress. It is hard to think of a better example of
the need for a clear statement of congressional authority than this one.
The Secretary and some of his supporters claim that regulating infectious diseases
through vaccines is not as unusual as the challengers maintain, pointing to a bloodborne
pathogen regulation from 1991. See 29 C.F.R. § 1910.1030. But that regulation shows what
works and what does not. The 1991 regulation required employers to make the hepatitis B
accine a ailable to emplo ees ho ha e occ pational e pos re to bloodborne pathogens at
no cost to the employee and at a reasonable time and place. Id. § 1910.1030(f)(1)(i) (ii).
Consider all of the differences between that regulation and this one. It narrowly targeted health
care orkers for protection from ir ses, partic larl those ca sing Hepatitis B and AIDS, that
can be transmitted in the blood of patients. A . De a A . Ma , 984 F.2d 823, 824 (7th
Cir. 1993). It did not regulate all American businesses, no matter the nature of the industry,
prod ct, or ser ice, so long as 100 emplo ees or more ork there. It as [p]rom lgated after a
protracted notice-and-comment r lemaking proceeding. Id. It did not sidestep that process.
And it appreciated the personal nature of the decision whether to get a vaccine that a truly
ol ntar program, in OSHA s ords, o ld foster greater emplo ee cooperation and tr st in
App. 209
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the s stem. 56 Fed. Reg. 64,004, 64,155 (Dec. 6, 1991). It did not press re or coerce
unvaccinated employees by imposing significant costs and burdens on them alone. Instead of
helping the Secretar s ca se, a comparison bet een the 1991 r le and the 2021 r le ndermines
it.
The Secretary relatedly points to a different part of the statute to suggest that Congress
contemplated imm ni ation hen delegating its a thorit . In a section on Research and
Related Acti ities, Congress gi es the Secretar of Health and H man Ser ices a thorit to
establish programs to examine and test the workplace to determin[e] the incidence of
occ pational illnesses. 29 U.S.C. 669(a)(5). The a thori ation comes ith this ca eat:
Nothing in this or an other pro ision of this chapter shall be deemed to a thori e or req ire
medical examination, immunization, or treatment for those who object thereto on religious
gro nds, e cept here s ch is necessar for the protection of the health or safet of others. Id.
This argument tries to squeeze a lot of power out of a very small statutory tube. It involves a
single reference to immunizations, a reference that explains when they are prohibited. It comes
from a different part of the statute and concerns the Secretary of Health and Human Services, not
OSHA and not the Secretar of Labor. If this is a clear statement of congressional a thorit
that OSHA may impose a vaccinate-or-test mandate on the American workforce, we should call
it a nearl silent r le, not a clear statement r le.
What of the Secretar s claim that he sho ld not be second-guessed for applying the
emergency rule just to companies with 100 employees or more? The problem is not second-
g essing; it is matching the Secretar s e planations for this emergenc r le ith its scope.
If the e planation for anno ncing an emergenc r le is the gra e dangers that American
workers face on the job from getting the virus, that risk applies to all companies in which
employees work together inside. Nor does it answer the point to say, as the Secretary does, that
he was concerned about imposing administrative burdens on smaller companies. Think of how
that argument would fare in another context. If the Secretary suddenly realized that exposure to
a ne chemical created a gra e danger of cancer, it is diffic lt to imagine that an one o ld
App. 210
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permit an emergency rule targeting the problem to apply only to companies with over 100
employees in order to save the other companies money.
What of a related reality that federal agencies historically have been able to impose
drug tests on workers? But, again, those regulations illustrate the permitted and forbidden sides
of the line. The Department of Transportation, to be sure, may require employees in a few
industries airlines, railroads, motor carriers, public transit to take periodic drug tests given the
flat-line risks to the public of having impaired pilots, conductors, truckers, or bus drivers. See,
e.g., 49 U.S.C. §§ 45102(a)(1), 20140(b)(1)(A), 31306(b)(1)(A), 5331(b)(1)(A). But that
authority, specific to a few industries and clearly delegated by Congress, would not give the
Department of Transportation power to require American workers to take a drug test to end the
opioid crisis even if such tests could save up to 100,000 lives a year.
This last question and answer largely take care of the next objection that the emergency
rule is needed to deal with certain types of private employers that have been devastated by virus
break-outs. A good example, as the Secretary and many others point out, is the meatpacking
industry, where many of the largest spreading events initially occurred. Two responses. As with
the special risks facing the transportation industry, Congress and OSHA may wish to focus on
special risks facing healthcare workers and the workers in other high-risk industries. But that is
not what this rule does. The other response is to note that the industries most at risk happen to be
the ones most proactive in addressing the risks of the pandemic. How could an emergency rule
be necessary to protect meatpacking workers when, so far as the record shows, that industry has
obtained high vaccination rates on its own? See, e.g., Am. P b. Health Ass n et al. Amic s Br. at
16 (noting that more than 96% of T son Food s 120,000 U.S. orkers are accinated); 86 Fed.
Reg. at 61,435. Just as the Secretary must match his assertion of power with the statute, he must
match his exercise of power with explanations in the record that fit the bill.
What of the collective-action problem at the root of this assertion of po er? Doesn t the
agency have authority to deal with the external costs created by vaccination decisions the cost
to others created by individuals who choose not to get vaccinated and the cost to society of
slowing down efforts to bring the virus to heel? See 86 Fed. Reg. at 61,539 (explaining that
App. 211
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accination red ces the risks that orkers present to others gi en the red ced likelihood of
transmission ); id. at 61,520 (noting that [c] rrent 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 ). B t, as sho n, the risk to accinated orkers from n accinated orkers is one
that the Secretar agrees is not a gra e danger. No less significantl , it s do btf l this federal
power sweeps this broadly given the vertical separation of powers embedded in our Constitution.
There is a Commerce Clause, yes. It gives Congress broad powers, to be sure. And it helps the
Federal Government to resolve some collective-action problems affecting interstate commerce,
no doubt. But through it all, it remains a Commerce Clause, not a collective-action clause and
not a clause that grants the national government all of the police powers customarily associated
with state governments in order to fix any new societal challenge.
That the Constitution permits the Federal Government to resolve some collective-action
problems facing societ b t not all of them simpl confirms that there are t o sides to toda s
stor . Tiger Lily, 5 F.4th at 675 (Thapar, J., concurring). On one side, yes, the Federal
Government has considerable authority to regulate and sometimes mandate what individuals may
do. But the other side reveals many libertarian guarantees of the U.S. Constitution, each
empowering individuals to resist national solutions to pedestrian and urgent policy problems
alike. Before we rush to lament the reality that American individualism may present obstacles to
q elling the pandemic as q ickl as e o ld like, it s orth keeping in mind that it is a national
trait that has done the co ntr some good from time to time. Perhaps indeed Americans
non-conformist ways have had something to do with American businesses bringing vaccines to
market more quickly than any vaccine in history and doing so more quickly than any other
country, collectivist or not, has been able to do. See Drew Armstrong, T e W d
Most Loathed Industry Gave Us a Vaccine in Record Time, Bloomberg Businessweek (Dec. 23,
2020), https://www.bloomberg.com/news/features/2020-12-23/covid-vaccine-how-big-pharma-
saved-the-world-in-2020; Jared S. Hopkins, How Pfizer Delivered a Covid Vaccine in
Record Time: Crazy Deadlines, a Pushy CEO, Wall St. J. (Dec. 11,
2020), https://www.wsj.com/articles/how-pfizer-delivered-a-covid-vaccine-in-record-time-crazy-
deadlines-a-pushy-ceo-11607740483.
App. 212
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What of the concern that the federal courts should take a low-impact approach to the
public policy exigencies created by a crisis like the pandemic? It is a fair question. But it
submits to fair answers. One is that, in the absence of a notice-and-comment process, the federal
co rts are all that s left. Who else, hat else, is there to assess nfo nded assertions of
emergency powers by a federal agency that will have irreversible consequences for American
workers and companies? The other answer is that overlooking rule-of-law limitations on federal
power usually increases it does not ameliorate the footprint of the federal courts. It is the rare
accretion of power to the President, Congress, or a federal agency that does not eventually take
the federal courts along for the ride.
V.
The other sta factors largel fa or the challengers as ell. Beca se OSHA s a thorit
extends only to regulating the workplace, the equities embedded in the stay factors do not extend
to the costs to society of having unvaccinated Americans. They extend only to the risks to
workers and companies.
From the perspective of the challengers, there are serious irreversible costs if the
emergency rule is immediately allowed to go into effect. Start with employees. The vaccinate-
or-test mandate has costs for them that cannot be undone. Whether it is an irreversible
vaccination, uncompensated testing costs, or a lost job, the affected employees face considerable
jeopardy if the federal courts mistakenly allow this rule to go into effect. The same is true of
employers, whether one focuses on the estimated $3 billion in compliance costs or the
difficulties small companies (with just over 100 workers) will face in competing with smaller
companies who can attract workers disinterested in complying with the mandate. From the
perspective of the Secretary of Labor and other parties that support the emergency rule, the main
risk of staying the rule is to unvaccinated American workers. But as we near the two-year
anniversary of the pandemic, it is hard to see why American workers are not allowed to assess
the risk-benefit choice of this personal medical decision for themselves. Even if the mandate
would have ancillary benefits for Americans who come into contact with unvaccinated workers
o tside the orkda , that consideration is not OSHA s to reg late. From the perspecti e of the
App. 213
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public interest, it is both wise and beneficial to stick with historical norms that the default rule
in agency rulemaking should be the notice-and-comment process, particularly when a rule
imposes highly consequential new regulations on American workers and companies and when
the agency has ne er in oked s ch a po er before. A lack of historical precedent tends to be
the most telling indication that no a thorit e ists. Free Enter. Fund v. Pub. Co. Acct.
Oversight Bd., 561 U.S. 477, 505 (2010) (quotation omitted).
All of this undermines the Secretar s ie that e sho ld lift the sta iss ed b the Fifth
Circuit. But it leaves unmentioned one other part of the stay calculation that the Secretary
estimated during the rulemaking process that the emergency rule would save 6,500 lives a
point unmentioned until now because it is never easy for judges to deal with. In one sense, it is
far better to have the President, Congress, an authorized federal agency, or the States making
cost-benefit decisions when American lives are at stake. Who are we to say when an emergency
rule should go into effect if the rule would save lives? The only thing that prevents such a job
from being unbearable is to appreciate that not every such decision is for us to make.
In this instance, the first answer is that the Secretary has assumed a power he does not
ha e. E en tho gh the CDC s e iction moratori m as defended on the same gro nd that it
would save thousands of lives the Supreme Court refused to allow the agency to enforce it.
A a. A f Rea , 141 S. Ct. at 2490. So also when States defended stay-at-home orders
that restricted religious services on the ground that they would save lives. These orders, too,
were stayed. Roman Cath. Diocese of Brooklyn v. Cuomo, 141 S. Ct. 63, 69 (2020) (per curiam).
The second answer is that, once judges go beyond the modest task of determining whether
statutes permit agency action, these broader considerations become exceedingly complicated
and well be ond o r ken. E en the Secretar s o n actions ill strate this complexity, especially
if saving lives is the only consideration. Look back on the many times when a vaccinate-or-test
mandate was not pressed by the Secretary: not in June 2021, when he issued the protective-gear
orders with respect to the healthcare industry; not in September 2021, when he initiated this
rulemaking procedure; and not on November 5, 2021, when he announced this six-month rule
and said it would not go into effect until January 4, 2022. Consider too the many Americans still
App. 214
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unprotected by this emergency rule: workers in companies with fewer than 100 employees and
all customers who visit any American retail store or business. But it would be no more fair to
criticize the Secretary of Labor on this ground than it would be to register a similar criticism
against the Fifth Circuit for staying the emergency rule. That takes us back to where we started:
The Secretar s emergenc r le likel e ceeds his a thorit .
The Court should grant the petition for initial hearing en banc and leave the Fifth
Circ it s sta of the emergenc r le in place.
App. 215
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________________________________________________________________
DISSENTING FROM THE DENIAL OF INITIAL HEARING EN BANC
________________________________________________________________
BUSH, Circuit Judge, dissenting from the denial of initial hearing en banc. This is a case
about the Occupational Safety and Health Administration, but it is really a case about power.
Specifically, it concerns the attempted exercise of a purported power to impose a de facto
national vaccine mandate1 upon some eighty-million Americans that OSHA was never given
and that Congress likely could never have given to it. Chief J dge S tton s dissent abl explains
the former defect, and so I join it in full. I write separately to address the latter.
Whether it uses a clear statement or not, Congress likely has no authority under the
Commerce Clause to impose, much less to delegate the imposition of, a de facto national vaccine
mandate upon the American public. Such claimed authority runs contrary to the text and
structure of the Constitution and historical practice. The regulation of health and safety through
compulsory vaccination is a traditional prerogative of the states not the domain of Congress
and certainly not fodder for the diktat of a federal administrative agency. Because we should
have granted initial hearing en banc to vindicate the correct understanding of the Constitution
and to cabin OSHA to its legitimate role, I respectfully dissent.
I.
This case has a veneer of complexity, so it is useful to start with some first principles of
constitutional adjudication. It may seem paradoxical that some of the most effusive guarantees
of liberty can be fo nd in the bills of rights of some of the orld s most sa age dictatorships.
See Antonin Scalia, Foreword: The Importance of Structure in Constitutional Interpretation,
83 N.D. L. Rev. 1417, 1418 (2008). Why do we seem to respect our bill of rights, at least in the
main, while other attempts have faltered the world over? The answer is structure. Id. Our
Framers nderstood that the tr e b l ark of libert is not a parchment g arantee[ ], b t the
diffusion of power both horizontally and vertically. Id. (quoting The Federalist No. 51, at 323
1For a disc ssion of h I appl this label to OSHA s standard, see infra pages 35 36.
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(James Madison) (Clinton Rossiter ed., 1961)); see also United States v. Morrison, 529 U.S. 598,
616 n.7 (2000) ( [T]he Framers crafted the federal s stem of Go ernment so that the people s
rights o ld be sec red b the di ision of po er. ).
James Madison called o r constit tional str ct re a do ble sec rit for the rights of
the people. The Federalist No. 51, supra, at 320 (James Madison). Power was first divided by
the Constit tion bet een t o distinct go ernments federal and state. Id. And that power
as then s bdi ided among distinct and separate departments legislative, executive, and
judicial. Id. Th s, j st as each go ernment as controlled b itself, the federal and state
go ernments o ld control each other. Id. The e tensi e portion of acti e so ereignt the
Constit tion left to the states o ld pre ent o r instit tions from degenerating into one
consolidated go ernment and o ld thereb check the res lting infringement on the people s
liberty. The Federalist No. 45, supra, at 286 87 (James Madison); see also New York v. United
States, 505 U.S. 144, 181 (1992) ( State so ereignt is not j st an end in itself: Rather,
federalism secures to citizens the liberties that deri e from the diff sion of so ereign po er.
(cleaned up)).
The constitutional text bears out that original design. Congress inherited from the
Constitutional Convention no roving warrant to legislate on whatever matter it sees fit. Indeed,
the Framers directly rejected such sweeping authority. See 2 The Records of the Federal
Convention of 1787, at 21 27 (Max Farrand, ed. 1911). That was not because the idea lacked a
proponent Go erne r Morris took the contro ersial position that the federal government
sho ld possess the police po er. William Michael Treanor, The Case of the Dishonest
Scrivener: Gouverneur Morris and the Creation of the Federalist Constitution, 120 Mich. L.
Rev. 1, 28 (2021). But he was alone in that view. No one else at the . . . Convention argued
that the national go ernment sho ld ha e the police po er. Id. at 29. Rather, Morris s fello
delegates spoke of it onl as a po er of the states. Id. And so our limited Constitution
emerged, caref ll en merating and th s caref ll cabining each federal branch s respecti e
powers. See Na Fed. f I de . B . . Sebe , 567 U.S. 519, 534 (2012) ( The en meration
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of po ers is also a limitation of po ers[.] ). As a result, when Congress wishes to legislate, it
m st sho that a constit tional grant of po er a thori es each of its actions. Id. at 535.
B t [t]he same does not appl to the States, beca se the Constit tion is not the so rce of
their po er. Id. States instead enjoy a residual authority to regulate within their borders a
power that pre-dates the Constitution and does not derive from it. Id. at 535 36. The Tenth
Amendment memoriali es that point, clarif ing that those po ers not delegated to the United
States b the Constit tion are reser ed to the States respecti el , or to the people. U.S.
Const. amend. X (emphasis added); see also Joseph Story, Commentaries on the Constitution of
the United States 711 12 (Ronald D. Rotunda & John E. Nowak, eds. 1987). The states under
o r federated s stem th s enjo a general po er of go erning what the Supreme Court has
repeatedl termed their police po er. Na Fed. f I de . B ., 567 U.S. at 536.
Part and parcel of that traditional police power and thus an a thorit reser ed to the
States is the power to regulate public health. U.S. Const. amend. X; Jacobson v.
Massachusetts, 197 U.S. 11, 25 (1905). Indeed, the Co rt has called it a settled principle[ ]
that states enjoy a police power to promulgate legislati e enactment[s to] protect the p blic
health and the p blic safet . Jacobson, 197 U.S. at 25; see also Chicago, B. & Q. Ry. Co. v.
Illinois, 200 U.S. 561, 592 (1906) (holding that the police po er of a State
embraces . . . regulations designed to promote the p blic health ); Berman v. Parker, 348 U.S.
26, 32 (1954) (describing reg lation of p blic health as a traditional application of the police
po er ). And in the specific context of compulsory vaccination, the Court has twice confirmed
that the propriety of such mandates is a matter vested to the police power of the states. See
Jacobson, 197 U.S. at 24 25; Zucht v. King, 260 U.S. 174, 176 (1922) (describing it as ithin
the police po er of a State to pro ide for comp lsor accination ).
Those holdings notwithstanding, OSHA invokes the Commerce Clause to suggest that it
is really the federal government, not the states, that enjoys the authority to mandate vaccination
for employees nationwide. Before I explore the constitutional validity of that position, let me
first explain why I label the standard a de facto national vaccine mandate for eighty-million
Americans. OSHA has not minced words about the purpose and effect of its standard; according
App. 218
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Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
to OSHA itself, [c]o ered emplo ers must develop, implement, and enforce a mandatory
COVID-19 accination polic for their emplo ees. 86 Fed. Reg. 61,402 (Nov. 5, 2021)
(emphases added). Thus, some half of our workforce must either become vaccinated or both
(1) ear a face co ering at ork in lie of accination and (2) s bmit to eekl testing for
COVID-19. Id. Neither OSHA nor the employer is required to bear the expense. Id. at 61,532.
Rather, it falls on the unvaccinated employee to shoulder the costs of compliance. Id. And if
states do not adopt OSHA s standard or some other plan that is at least as effecti e, the face
penalties like the revocation of approval of their State Plans and the associated loss of millions in
federal funding. See Emergenc Temporar Standard, Occupational Safety and Health
Administration, https://www.osha.gov/coronavirus/ets2/faqs (last visited Dec. 14, 2021)
(e plaining that if a State Plan is not at least as effecti e as OSHA s emergenc r le,
conseq ences incl de OSHA s reconsideration and possible re ocation of the State Plan s final
appro al stat s ); see also What is an OSHA-Appro ed State Plan? , id.,
https:// .osha.go /stateplans/faqs (last isited Dec. 14, 2021) ( OSHA appro es and
monitors all State Plans and provides as much as 50 percent of the f nding for each program. ).
So again, what constitutional warrant does OSHA possess for this scheme? The agency
appeals to commerce. But the Commerce Clause likely cannot be read to grant such an
authority, because it cannot be read to confer a general police power upon the national
government. True, the Court has at times read the Clause broadly, stretching its meaning to the
edge of plausibility. See, e.g., Wickard v. Filburn, 317 U.S. 111 (1942). Yet the Court has never
crossed the Rubicon of declaring a federal police power. Time after time, it has rejected the
notion that such a power exists. See United States v. Lopez, 514 U.S. 549, 566 (1995)
(e plaining that the Constit tion ithhold[s] from Congress a plenar police po er ); id. at 584
(Thomas, J., conc rring) ( [W]e always have rejected readings of the Commerce Clause and the
scope of federal po er that o ld permit Congress to e ercise a police po er[.] ); Na Fed. f
Indep. Bus., 567 U.S. at 536 ( O r cases refer to this general power of governing, possessed by
the States b t not b the Federal Go ernment, as the police po er. ). So the Commerce
Cla se, hich generated no apprehensions pon its addition to the Constit tion, cannot be read
to effect a late-breaking revolution in state-federal affairs by granting a federal agency the right
App. 219
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Health Admin. Rule on COVID-19 Vaccination
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to regulate a core area of traditional state concern. The Federalist No. 45, supra, at 290 (James
Madison).
What first principles dictate, fresh precedent confirms. The Supreme Court in recent
ears has sq arel rejected a ie of the commerce po er nder hich indi id als ma be
regulated . . . whenever enough of them are not doing something the Government would have
them do. Na Fed. f I de . B ., 567 U.S. at 553 (opinion of Roberts, C.J.); accord id. at
649 60 (Scalia, Kennedy, Thomas, and Alito, JJ., dissenting). The case I mention involved an
individual mandate to coerce those without health insurance to purchase it. Id. Congress
claimed the power to regulate the failure to engage in a commercial activity the buying of
insurance beca se nins red persons fail re to do so had a s bstantial aggregate effect on
interstate commerce. Id. at 554. Here, by contrast, OSHA claims the power to regulate the
failure to engage in a non-commercial activity the taking of a vaccine because unvaccinated
persons fail re to do so ma affect interstate commerce. OSHA s theor of the commerce
power is thus even more extravagant than what the Supreme Court has already rejected.
If Congress cannot sol e a percei ed commercial problem ith a mandator p rchase, then
how can it possess the authority, much less delegate it, to solve a perceived commercial problem
by mandating that Americans engage in a non-commercial activity?2 Id. at 553. The answer, of
course, is that it likely cannot.
Before I turn to history, let me close with a final word on precedent, lest I be
misunderstood. Here, I do not question the constitutionality of OSHA itself, or of federal
workplace-safety regulations more broadly. But see Cass R. Sunstein, Is OSHA
Unconstitutional?, 94 Va. L. Re . 1407 (2008) (q estioning OSHA s constit tionalit on non-
delegation grounds). For even accepting that Congress (and thus, perhaps, OSHA) has the power
to regulate a workplace hazard that affects interstate commerce, that is not what OSHA has done.
OSHA has instead pretextually redefined what is at this point a hazard of life in the United States
2 The states arguing in support of the stay put it this way: If Congress does not have the power under the
Commerce Clause to force individuals to buy health insurance, could it make an end-run around that rule by telling
employers that they cannot retain uninsured employees? And if Congress cannot do so, then why can it tell
employers that they cannot retain unvaccinated employees?
App. 220
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and throughout the world COVID-19 as a hazard of the workplace. See, e.g., 86 Fed. Reg. at
61,545 (misleadingly characterizing COVID-19 as a orkplace ha ard ). It engages in this
pretext in its attempt to bring a traditional matter of state concern compulsory vaccination
within the ambit of federal jurisdiction. But caselaw is clear. Neither Congress nor OSHA may
prete t all relabel s ch an area as commerce to gain hat is, in effect, a no el police po er
of the national government. See Morrison, 529 U.S. at 616 18 (rejecting the notion that
Congress may regulate domestic iolence merel beca se of a p rported effect on interstate
commerce ); see also id. at 617 18 ( The Constit tion req ires a distinction bet een hat is
tr l national and hat is tr l local. ); Lopez, 514 U.S. at 567 68 (rejecting Congress s attempt
to relabel firearms near schools a problem of interstate commerce).
II.
Given that OSHA is so disarmed of precedent, one might reasonably have expected it to
come into court bearing historical examples of the power it seeks to exercise the federal
imposition of a de facto nationwide vaccine mandate. Yet it has none. To the contrary, the
rele ant histor act all nderc ts OSHA s position. For while Congress has long sought to
facilitate safe and effective vaccines, it has never invoked the commerce power to mandate their
administration upon the public at large.3
In the early years of the Republic, Congress did little to respond to epidemics. 4 In the
s mmer of 1793, for e ample, ello fe er descended on Philadelphia, then the nation s capital.
See Letter from Thomas Jefferson to Martha Jefferson Randolph (Sept. 8, 1793), Founders
3To be sure, the federal government has, at one time or another, mandated vaccination for discrete
segments of the population, such as for soldiers or members of the foreign service working abroad. George
Washington himself ordered that his soldiers in the Continental Army receive variolation against smallpox in the
winter of 1777. See Ann M. Becker, S a Wa g A : S a eg c I ca f e D ea e D g
the American Revolutionary War, 68 J. of Mil. Hist. 381, 427 28 (2004). But the relevant question is not whether
the federal government has the authority to order the vaccination of certain populations in a special relationship with
it. What is at stake here is whether Congress has a general police power to mandate vaccination for tens of millions
of private citizens with no special relationship to the federal government. History suggests that it has no such
power.
4And when it did intervene, it did not impose unilateral mandates upon the states, but instead assisted in a
cooperative fashion. See Act of Ma 27, 1796, 4 Cong. Ch. 31, 1 Stat. 474 (a thori ing the President to aid in the
execution of quarantine, and also in the execution of the health-laws of the states d ring a ello -fever epidemic).
App. 221
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Online, https://founders.archives.gov/documents/Jefferson/01-27-02-0060 (last visited Dec. 12,
2021); see also Letter from George Washington to Edmund Randolph (Sept. 30, 1793), Founders
Online, https://founders.archives.gov/documents/Washington/05-14-02-0105 (last visited Dec.
12, 2021); James Higgins, P blic Health, Enc clopedia of Greater Philadelphia,
https://philadelphiaencyclopedia.org/archive/public-health/ (last visited Dec. 12, 2021); Mathew
Carey, A Short Account of the Malignant Fever, Lately Prevalent in Philadelphia 11 (1794),
available at Harv. Univ. Lib. Viewer, https://iiif.lib.harvard.edu/manifests/view/drs:7374219$11i
(last visited Dec. 14, 2021) (describing the destro ing sco rge, the malignant fe er, that had
crept in among s ). The federal go ernment s response as primaril to lea e to n for the
countryside. See Letter from Thomas Jefferson to Martha Jefferson Randolph, supra. President
Washington chose to work remotely at Mount Vernon; the Secretary of State, Thomas Jefferson,
fled to Monticello. Id.
There was no vaccine available in the 1790s for yellow fever but, in 1796, Sir Edward
Jenner discovered a vastly improved vaccination for smallpox rather than use live virus as had
the earlier ariolation process, Jenner sed co po instead. See Stefan Riedel, Edward Jenner
and the History of Smallpox and Vaccination, 18 Baylor U. Med. Ctr. Proceedings 21, 23 24
(2005). That discovery led Congress less than two decades later, in 1813, to enter the vaccine
arena. See Tess Lanzarotta & Marco A. Ramos, Mistrust in Medicine: The Rise and Fall of
A e ca F Vacc e I e, 108 Am. J. of Pub. Health 741 (2018). In response to an
outbreak of smallpo , Congress passed An Act to Enco rage Vaccination, sometimes called
the Vaccine Act of 1813. Id. at 742; see also James Colgrove, Immunity for the People: The
Challenge of Achieving High Vaccination Coverage in American History, 122 Pub. Health Rep.
248, 249 (2007).
The Act had three salient features: it created the position of a federal vaccine agent, gave
him the authority to curate an unadulterated supply of smallpox vaccine, and gave him a franking
privilege to distribute vaccines to those who requested them, free of charge, through the U.S.
mail. Id. Noted Mar land ph sician James Smith ser ed as the nation s first (and onl ) accine
agent for nine ears, o erseeing t ent agents nation ide ho inoc lated aro nd 100,000
App. 222
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Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
people d ring his tenure. See Letter from James Smith (of Baltimore) to Thomas Jefferson
(Mar. 28, 1818), Founders Online, https://founders.archives.gov/documents/Jefferson/03-12-02-
0472 (last visited Dec. 12, 2021). Yet Smith s role as accine agent and the Vaccine Act
itself came to a tragic end in 1822. See Lanzarotta & Ramos, supra, at 742. Smith
accidentally shipped packages of live smallpox (rather than cowpox vaccine) to the town of
Tarboro, North Carolina, resulting in ten fatalities. Id. Two months later, President Monroe
dismissed Smith from his position and Congress repealed the Act, relinquishing further
vaccination efforts to the states. Id.
Public response to the vaccine was strikingly similar to modern attitudes about the
COVID vaccine. Many voluntarily took the smallpox vaccine and gave it to their children. See,
e.g., The Diaries of Gouverneur Morris: New York 1799 1816, 777 (Melanie Randolph Miller,
ed. 2018); see also Letter from Abigail Adams to John Adams (July 13, 1776), Mass. Hist.
Society, https://www.masshist.org/digitaladams/archive/doc?id=L17760713aa (last visited Dec.
14, 2021). But others, like some today, were suspicious of a vaccine. See Cynthia M.A. Geppert
& Reid A. Paul, The Shot That Won the Revolutionary War and Is Still Reverberating, Fed.
Practitioner 298, 298 (2019), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6654165/pdf/fp-
36-07-298.pdf (last visited Dec. 14, 2021). And smallpox was as devastating and transmissible,
if not more so, than COVID-19. See Histor of Smallpo , Centers for Disease Control and
Prevention, https://www.cdc.gov/smallpox/history/history.html (last visited Dec. 12, 2021). Yet
there is no indication that anyone in the 1813 Congress thought the federal government had a
general police power to nationally mandate vaccination.
Congressional involvement in vaccination ever since has followed the basic contours of
the 1813 regime. Congress has passed many laws to regulate the purity of vaccines, facilitate
their distribution with information and funding, and compensate those injured by their
administration, but it has apparently never invoked the commerce power5 to mandate their
5I pause to note a seeming counterexample that is, upon further inspection, no counterexample at all. In
1832, Congress passed the Indian Vaccination Act a functional vaccine mandate for those tribes selected for
smallpox vaccination by federal Indian agents. See J. Diane Pearson, Lewis Cass and the Politics of Disease: The
Indian Vaccination Act of 1832, 18 Wicazso Sa Rev. 9, 12 (2003) (noting that it as left to the secretar of ar to
App. 223
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Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
imposition upon the general public. See, e.g., Biologics Control Act, Pub. L. No. 57-244, 32
Stat. 728 (1902) (current version at 42 U.S.C. § 262 (2006)); see also Pure Food and Drug Act of
1906, Pub. L. No. 59-384, 34 Stat. 768; Virus-Serum-Toxin Act, ch. 145, § 1, 37 Stat. 832
(1913) (current version at 21 U.S.C. §§ 151 159); Federal Food, Drug, and Cosmetic Act, Pub.
L. No. 75-717, 52 Stat. 1040 (1938); Public Health Service Act, Pub. L. No. 78-410, 58 Stat. 682
(1944); Poliomyelitis Vaccination Assistance Act of 1955, Pub. L. No. 277, 69 Stat. 704;
National Childhood Vaccine Injury Act, Pub. L. No. 99-660, 100 Stat. 3755 (1986); Food and
Drug Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296.
The Poliomyelitis Vaccine Assistance Act of 1955 provides a good example. Soon after
Dr. Jonas Salk developed the first effective polio vaccine in 1955, Congress responded with
millions of dollars in grants to assist states in accinating children nder 20 and e pectant
mothers, ith f nds allotted to the states according to their respecti e needs. See Otis L.
Anderson, The Polio Vaccine Assistance Act of 1955, 45 Am. J. Pub. Health 1349, 1349 (1955).
Yet it as the states [that had] responsibility for the intrastate distribution of the vaccine
thro gh both p blic agenc and normal commercial channels. Id. (emphasis added); see also
42 U.S.C. § 243(a) (directing the Secretar of Health and H man Ser ices to assist States . . . in
the pre ention and s ppression of comm nicable diseases and to cooperate with and aid State
and Local a thorities. (emphases added)).
OSHA would turn this history on its head. It proposes not a partnership in which the
federal government simply encourages vaccination, but an unfunded mandate in which half our
workforce must either become vaccinated or subject itself to regular out-of-pocket testing. See
86 Fed. Reg. at 61,532. If Congress p rported to delegate s ch a sensiti e mone or li es
determine which American Indians were vaccinated and when and where they would be vaccinated. American
Indians had no input into any of the political or decision-making processes involved with the bill or into
implementation of the act. ). The Act s marketing as beneficent, id. at 10, but its administration was sinister.
Indian agents selected for vaccination (1) those tribes scheduled for removal, so that smallpox would not derail the
journey, id. at 25, and (2) tribes that were considered valuable trading partners of the United States. Id. at 19 23.
B contrast, tribes considered be ond the pale of ci ili ation ere deliberatel e cl ded from accination. Id. at
20. Even if a modern agency were inclined to rely on this poisoned precedent, see Ramos v. Louisiana, 140 S. Ct.
1390, 1401 & n.44 (2020), it would do nothing to advance an interpretation of the Commerce Clause. Congress
reg lates Indian tribes internal affairs nder a s pposed plenar po er much as a state would regulate its own
citizens rather than under its commerce authority. See Puerto Rico v. Sanchez Valle, 579 U.S. 59, 70 (2016).
App. 224
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Nos. 21-7000, et al. In re: MCP No. 165, Occupational Safety & Page 42
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
determination to an unaccountable agency, we would have to think hard about the propriety of
that delegation. See I d . U De , AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607, 687
(1980) (Rehnquist, J., concurring in the judgment). Yet here there likely existed no authority to
delegate.
III.
I have no doubt that the pandemic imperils our society, and I recognize that there is
sometimes a j dicial imp lse to sta o t of the a in times of crisis. Roman Catholic
Diocese of Brooklyn v. Cuomo, 141 S. Ct. 63, 71 (2020) (Gorsuch, J., concurring). But while an
emergenc ma afford a reason for the e ertion of a li ing po er alread enjo ed, it cannot
call into life a po er hich has ne er li ed. Wilson v. New, 243 U.S. 332, 348 (1917). OSHA
claims just such a power history and precedent notwithstanding. It is surely incumbent on the
third branch in these circ mstances to check the actions of the fo rth. And because the full
court should have had the opportunity to do so, I respectfully dissent.
ENTERED BY ORDER OF THE COURT
___________________________________
Deborah S. Hunt, Clerk
App. 225
Appendix 5
App. 226
Case: 21-7000 Document: 386-2 Filed: 12/17/2021 Page: 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 > Nos. 21-7000
SERVICES, LLC (21-4027); PHILLIPS MANUFACTURING & TOWER COMPANY, et /4027 /4028 /4031
al. (21-4028); COMMONWEALTH OF KENTUCKY, et al. (21-4031); ANSWERS IN /4032 /4033 /4080
GENESIS, INC. (21-4032); SOUTHERN BAPTIST THEOLOGICAL SEMINARY, et al. /4082 /4083 /4084
(21-4033); BST HOLDINGS, LLC, et al. (21-4080); REPUBLICAN NATIONAL /4085 /4086 /4087
/4089 /4088 /4090
COMMITTEE (21-4082); ASSOCIATED BUILDERS AND CONTRACTORS, INC., et al. /4091 /4093 /4092
(21-4083); MASSACHUSETTS BUILDING TRADES COUNCIL (21-4084); UNION OF /4095 /4094 /4096
AMERICAN PHYSICIANS AND DENTISTS (21-4085); ASSOCIATED GENERAL /4097 /4099 /4100
CONTRACTORS OF AMERICA, INC., et al. (21-4086); NATIONAL ASSOCIATION OF /4101 /4102 /4103
BROADCAST EMPLOYEES & TECHNICIANS, THE BROADCASTING AND CABLE /4108 /4112 /4114
TELEVISION WORKERS SECTOR OF THE COMMUNICATIONS WORKERS OF /4115 /4117 /4133
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.
App. 227
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Nos. 21-7000, et al. In re: MCP No. 165, Occupational Safety & Page 2
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
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,
Wa hing on, D.C., Kei h R. Bolek, O DONOGHUE & O DONOGHUE LLP, Wa hing on, 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
App. 228
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Nos. 21-7000, et al. In re: MCP No. 165, Occupational Safety & Page 3
Health Admin. Rule on COVID-19 Vaccination
and Testing, 86 Fed. Reg. 61402
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
po ing ne ri k . Recogni ing ha he old normal i no going o re rn, emplo er 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 e abli hed OSHA oa re afe and heal hf l orking condi ion for he na ion ork
force and o pre er e he na ion h man re o rce . A be I f . A /N. A . .
Occupational Safety & Health Admin., 727 F.2d 415, 417 (5th Cir. 1984). It expressly found that
per onal inj rie and illne e ari ing o of ork i a ion impo e a b an ial b rden pon,
and are a hindrance to, interstate commerce in terms of lost production, wage loss, medical
e pen e , and di abili compen a ion pa men . 29 U.S.C. 651(a). OSHA i charged ih
en ring orker afe and heal h b de eloping inno a i e me hod , echniq e , and
approache for dealing i h occ pa ional afe and heal h problem . Id. § 651(b)(5). To fulfill
ha charge, Congre a hori ed he Secre ar of Labor ( he Secre ar ) o e manda or
occupational safety and health standards applicable to businesses affec ing in er a e commerce.
Id. 651(b)(3). And i e ed he Secre ar i h broad a hori . . . to promulgate different
kind of andard for heal h and afe in he orkplace. I d . U De , AFL-CIO v. Am.
Petroleum Inst., 448 U.S. 607, 611 (1980) (plurality opinion); see, e.g., N. A . B dg. T ade
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 occ pa ional afe and heal h andard i one ha req ire condi ion , or he
adoption or use of one or more practices, means, methods, operations, or processes, reasonably
necessary or appropriate to provide safe or healthf l emplo men and place of emplo men .
29 U.S.C. § 652(8). Before going in o effec , OSHA andard m ndergo a no ice-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 circ m ance , OSHA hall prom lga e an emergenc emporar
andard ha ake immedia e effec . 29 U.S.C. 655(c)(1). Emergenc emporar andard
do not displace notice-and-commen req iremen ; ra her, he ETS er e a he propo ed r le,
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 i ing an ETS, OSHA m de ermine: (1) ha emplo ee are
exposed to grave danger from exposure to substances or agents determined to be toxic or
ph icall harmf l or from ne ha ard , and (2) ha an emergenc andard i nece ar o
pro ec emplo ee from ch danger. Id. § 655(c)(1).
With respect to any OSHA standard emergency or otherwise employers may seek a
ariance from he andard. Id. § 655(d). Under that provision, an employer must demonstrate
ha he condi ion , prac ice , mean , me hod , opera ion , or proce e ed or propo ed o 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 i h he andard.
Id.
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B. Factual Background
OSHA monitored the COVID-19 pandemic from the beginning. As early as April 2020,
OSHA o gh o pro ec orker hro gh ide pread ol n ar compliance ih afe
g ideline , pecif ing that workplaces should comply with personal protective equipment
standards, see 29 C.F.R. § 1910, and b reinforcing emplo er general d o f rni h each
orker emplo men and a place of emplo men , hich are free from recogni ed ha ard ha
are ca ing or are likel o ca e dea h or erio ph ical harm, see 29 U.S.C. § 654(a)(1).
Gi en he pandemic rajec or and the emergence of rapidly-spreading variants causing
increa e in infec io ne and ran mi ion, 86 Fed. Reg. a 61,409 OSHA found that its
nonreg la or enforcemen ool ere inadeq a e o en re all orking indi id al afe
and heal hf l orking condi ion . 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
addre he e raordinar and e igen circ m ance pre en ed b hi npreceden ed
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
emplo er o op o of an accina ion policie ). Emplo er ha e he op ion o req ire
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. a 61,436 ( [T]his ETS offers employers a choice in how to comply . . . . ).
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Emplo er m al o confirm heir emplo ee accina ion a and keep record of ha
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 a hori oi e ch an ETS and OSHA ba i for he 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,
he Fif h Circ i i ed a ri en opinion, reaffirming he ini ial a af er ha ing cond c ed . . .
[an] e pedi ed re ie . 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
fac or , he Fif h Circ i fo nd ha indi id al , a e , and emplo er o ld be b an iall
b rdened d e o he compliance co , lo of con i ional freedom, and in r ion in o S a e
con i ionall re er ed police po er. Id. a 618. Wi ho addre ing an of OSHA fac al
explanations or its supporting scientific evidence concerning harm, the Fifth Circuit summarily
concl ded ha a a ill do OSHA no harm ha oe er and a a i firml in he p blic
intere . 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 o di ol e he Fif h Circ i a . Under 28 U.S.C. 2112(a)(4), e re ie de no o he
challenged a pec of he ETS o de ermine he her he Fif h Circ i a ho ld be modified,
revoked, or extended.
A. Standard for Stay
A a i an in r ion into the ordinary processes of administration and judicial
re ie . Nken v. Holder, 556 U.S. 418, 427 (2009) (quoting Va. Pe e J bbe A . v.
Fed. P e C , 259 F.2d 921, 925 (D.C. Cir. 1958)). Therefore, i i no a ma er of righ ,
even if irreparable inj r migh o her i e re l o he appellan . Id. (quoting Virginian Ry. Co.
v. United States, 272 U.S. 658, 672 (1926)). [T]he hea b rden for making o a ca e for ch
e raordinar relief re on he mo ing par ie . 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 a or A hori
Pe i ioner arg men are primaril gro nded in he Fif h Circ i blanke concl ion
ha he ETS i be ond he cope of OSHA a or a hori . The ETS a i ed nder
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§ 655(c)(1) of the Act, which requires OSHA to issue an emergency standard if necessary to
pro ec orker from a gra e danger pre en ed b e po re o b ance or agen
de ermined o be o ic or ph icall harmf l or from ne ha ard . 29 U.S.C. 655(c)(1). In
assessing that authority, the Fifth Circuit focused solely on the words in § 655(c)(1): b ance
or agen , o ic or ph icall harmf l, and gra e danger, opining ha ho e ord are o 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 . Na S d Wa e
Mg .A , 505 U.S. 88, 99 (1992) (in r c ing ha , hen e al a ing a a e, a co r m
not be guided by a single sentence or member of a sentence, but look to the provisions of the
hole la ). We herefore ake a holi ic ie of he lang age ha Congre chose to include in
its statutory authorization to OSHA.
An agen i a chemicall , ph icall , or biologicall ac i e principle. Agent,
Merriam-Webster Collegiate Dictionary, https://unabridged.merriam-webster.com/collegiate/
agent. And a virus is defined, in par , a an large gro p of bmicro copic infec io agen .
Virus, Merriam-Webster Collegiate Dictionary, https://unabridged.merriam-webster.com/
collegia e/ ir . The a e req ire OSHA o de ermine he her an agen i o ic or
physically harmful or from ne ha ard , 29 U.S.C. 655(c)(1) (emphasis added), speaking in
he di j nc i e, hich pecifie ha ord o connec ed are o be gi en epara e meaning ,
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 o ic (i.e., poi ono , o ici ) or ph icall harmf l (i.e.,
ca ing bodil harm) fall i hin OSHA p r ie . An agen ha ca e bodil harm a
virus falls squarely within the scope of that definition.
O her pro i ion of he Ac reinforce OSHA a hori o reg la e infec io di ea e
and viruses. As explained above, Congress enacted the OSH Act under the Commerce Clause
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beca e Congre fo nd ha illnesses arising out of work situations impose a substantial burden
upon . . . in er a e commerce. 29 U.S.C § 651(a) (emphasis added). Congress created the
safety and health admini ra ion o pro ec orker from ho e illne e b red cing heal h
hazards at their place of emplo men . Id. 651(b)(1). The Ac objec i e incl de e ploring
a o di co er la en di ea e , e abli hing ca al connec ion be een di ea e and ork in
environmental conditions, and conducting other research relating to health problems . . . . Id.
§ 651(b)(6). And finall , he Ac o gh o pro id[e] medical cri eria hich ill a re in ofar
as practicable that no employee will suffer diminished health, functional capacity, or life
e pec anc a a re l of hi ork e perience. 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
con l a ion i h he Secre ar of Labor o de elop informa ion regarding potentially toxic
b ance or harmf l ph ical agen , incl ding hro gh medical e amina ion and e . Id.
§ 669(a)(5). That provision also contains the religious exemption for the entire OSH Act:
[n]o hing in hi or an o her pro i ion of this chapter shall be deemed to authorize or require
medical examination, immunization, or treatment, for those who object thereto on religious
gro nd , e cep here ch i nece ar for he pro ec ion of he heal h or afe of o her . Id.
The pro i ion reference o imm ni a ion and i crea ion of a limi ed e cep ion o he Ac
authorization of standards involving immunization would be rendered meaningless if the statute
did no con empla e bo h ha harmf l agen incl de infec io , di ea e-causing agents, such
as viruses, and that OSHA would employ the use of immunizations to combat those agents.
Congre confirmed OSHA infec io di ea e a hori in o her a e . 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 b a da e cer ain, arning ha if
[OSHA] did no mee i deadline, he propo ed andard o ld become effec i e in he in erim.
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 Ac . The a e re l ed from finding ha ha ardo chemical and b ance ere
being ran por ed home on orker and heir clo hing po ing a hrea o he heal h and elfare
of orker and heir familie . 29 U.S.C. 671a(b)(1)(A) (B). Section 671a requires the
Na ional In i e for Occ pa ional Safe and Heal h o ork i h OSHA o d i e
rela ed o he con amina ion of orker home i h ha ardo chemical and substances,
including infectious agents, ran por ed from he orkplace of ch orker . 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 ch andard p r an o . . . the
Occ pa ional Safe and Heal h Ac 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
andard, no par challenged OSHA a hori o reg la e bloodborne pa hogen . See Am.
De a A . Ma , 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 he American Re c e Plan ha i o be ed o carr o COVID-19 related worker
pro ec ion ac i i ie . Pub. L. No. 117-2, § 2101, 135 Stat. 4, 30 (2021).
Ba ed on he OSH Ac lang age, r c re, and Congre ional appro al, OSHA ha
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
emplo er engaged in ha ardo a e clean p o pro ec again an biological agen and o her
disease-ca ing agen ha pon e po re, inge ion, inhala ion or assimilation into any
person,. . . ill or ma rea onabl be an icipa ed o ca e dea h [or] di ea e, id.
§ 1910.120(a)(3); requiring use of respirators to prevent occupational diseases caused by
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harmf l d , fog , f me , mi , ga e , moke , pra , or apor , 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).
Gi en OSHA clear and e erci ed a hori o reg la e ir e , OSHA nece aril ha
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
co r ha e pheld OSHA a hori o reg la e ha ard ha co-exist in the workplace and in
society but are at heightened risk in the workplace. See, e.g., F g g I d . A . Sec f
Labor, 773 F.2d 1436, 1442 43 (4th Cir. 1985) (en banc) (rejec ing he arg men ha beca e
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
ca e ); A . De a A , 984 F.2d a 826 (recogni ing ha he infec io charac er of HIV
and HBV warrant[s] even on narrowly economic grounds more regulation than would be
nece ar in he ca e of a noncomm nicable di ea e ); see also 29 C.F.R. § 1910.1025 (OSHA
regulates workplace exposure to lead).
Long anding preceden addre ing he plain lang age of he Ac , OSHA in erpre a ion
of the statute, and examples of direct Congressional authorization following the enactment of the
OSH Ac all ho ha OSHA a hori incl de 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
emplo ee , moreo er, i hardl limi ed o hard ha and afe goggle . OSHA ha ide
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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en e ha OSHA a hori con empla e he e of medical e am and accina ion a ool in
its arsenal. See id. at 1228 40 (concluding that OSHA has the authority to require medical
surveillance of lead levels). To gge o her i e o ld mean ha Congre had o ha e
anticipated both the unprecedented COVID-19 pandemic and the unprecedented politicization of
the disease to regula e accina ion again i. F da . De f Hea &H . Se ., 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
orkplace . The lang age of he OSH Ac plainl a hori e OSHA o ac on i charge o
a re afe and heal hf l orking condi ion for he na ion ork force and o pre er e he
na ion h man re o rce . A be I f .A , 727 F.2d at 417.
2. Major Questions Doctrine
Ha ing e abli hed OSHA a or a hori , e pa e o addre Pe i ioner and he
Fif h Circ i arg men per aining o he major q e ion doc rine. The Fif h Circ i
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 a or a hori . Congre m peak clearl if i i he o a ign
o an agenc deci ion of a economic and poli ical ignificance. 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 o ide of OSHA core compe encie , and p rpor o defini i el re ol e one
of oda mo ho l deba ed poli ical i e . There i no clear e pre ion 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 a hori 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 an agenc reg la or ac ion bring[ ] abo an enormo and
ran forma i e e pan ion in [ he agenc ] reg la or a hori , hen here m be clear
App. 240
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congre ional a hori a ion. Util. Air Regul. Grp., 573 U.S. a 324. We e pec Congre o
peak clearl if i i he o a ign o an agenc deci ion of a economic and poli ical
ignificance. 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 q e ion doc rine i inapplicable here, ho e er, beca e OSHA i ance 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 no el e pan ion of OSHA
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
he scope or degree of he po er an agenc ield . (Di en Op. a 53) Our conclusion rests
on m ch more, incl ding: An e en i e ca alog of OSHA reg la or a hori , ci ing he e
of the Act and precedent, both replete with references that contemplate the authority OSHA uses
here; he ac al componen of OSHA ork such as its many years of regulating illness in the
orkplace; and o her a e ackno ledging OSHA a hori , incl ding one ha 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
a hori o reg la e dr g e ended o cigare e , b Congre had repeatedly declined to
grant the FDA that authority. See 529 U.S. at 125, 137 39.
An do b a o OSHA a hori i a aged b he lang age of the OSH Act. In
arguing that OSHA does not have this authority, Petitioners and the Fifth Circuit rely on the
S preme Co r and he Si h Circ i recen ca e in oking he major q e ion doc rine
App. 241
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regarding a nationwide moratorium on evictions in counties experiencing high levels of COVID-
19 transmission. See A a. A f Rea . U.S. De f Hea &H . Se ., 141 S. Ct.
2485 (2021); T ge L , LLC . U.S. De fH . & U b. De ., 5 F.4th 666 (6th Cir. 2021).
The Centers for Disease Control and Prevention (CDC) promulgated the moratorium under
§ 361(a) of he P blic Heal h Ser ice Ac (PHSA), referencing i broad a hori o ake
whatever measures it deems necessary to control the spread of COVID-19. A a. A f
Realtors, 141 S. Ct. at 2488. The Supreme Court determined that clear language in the PHSA
e pre l limi ed he cope of he CDC a hori o pecific mea re , hich cope did no
include moratoria. Id. The Co r no ed ha [e] en if he e ere ambig o , he heer scope
of he CDC claimed a hori nder 361(a) o ld co n el again he Go ernmen agenc
in erpre a ion. 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 o ha e ch a hori , i needed o enac e ceedingl clear lang age o ha effec . Id.
(quoting U.S. Forest Ser . . C a eR e P e .A , 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. A a A f Rea , 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 ETS a hori i circ mscribed 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.
App. 242
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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.
Thi i , herefore, differen from he CDC a hori nder he PHSA, hich pro ided a limi ed
cope of ool o effec a e he Ac p rpo e , hich cope did no incl de moratoria, and which
reg la ed an area no radi ionall in he CDC heelho e.1 Finally, the same federalism
concern are no a i e here: [a]l ho gh . . . p blic heal h i e . . . ha e radi ionall been
a primary concern of state and local official , Congre , in adop ing he OSH Ac , decided ha
he federal go ernmen o ld ake he lead in reg la ing he field of occ pa ional heal h.
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 m, he major q e ion doc rine i inapplicable here. OSHA i ance of he ETS i
not a transformative expansion of its regulatory power as OSHA has regulated workplace health
and safety, including diseases, for decades.
3. OSHA 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
immedia e effec and er e a a propo ed r le for a no ice-and-comment rulemaking if it
de ermine : (1) ha emplo ee are e po ed o gra e danger from e po re o b ance or
agen de ermined o be o ic or ph icall harmf l or from ne ha ard , and (2) that a
andard i nece ar o pro ec emplo ee from ch danger. 29 U.S.C. § 655(c). Those
de ermina ion are concl i e if ppor ed b b an ial e idence in he record a a hole.
1In comparing this case with Alabama Association, he Fif h Circ i ro e, B heal h agencie do no
make ho ing polic , and occ pa ional afe admini ra or do no make heal h polic . 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 Congre declare i o be i p rpo e and polic . . . to assure so far
as possible every working man and woman in the Nation safe and healthful working conditions . . . . (empha i
added)).
App. 243
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Id. 655(f). On j dicial re ie , e de ermine he her he record con ain ch rele an
e idence a a rea onable mind migh accep a adeq a e o ppor a concl ion. Asbestos
I f .A , 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,
he na re of he e idence in hi ca e req ire ha e inq ire in o he her OSHA carried o
[i ] e en iall legi la i e a k in a manner rea onable nder he a e of he record before [i ].
Id. at 421 (quoting A a S de D eC . .C e P d. Safe C , 569 F.2d 831,
838 (5 h Cir. 1978)). To hi end, deference i gi en o OSHA fac -finding expertise. Id.
(citing A a S de D eC ., 569 F.2d a 838). While em ake a harder look a
OSHA ac ion han e o ld if e ere re ie ing he ac ion nder he more deferen ial
arbi rar and capricio andard, id. at 421, by the very nature of the administrative
proceeding, some flexibility is to be exercised in judicial review, id. at 422.
The co r can re ie [ he] da a in he record and de ermine he her i reflec
b an ial ppor for he Secre ar finding . I d . U De , AFL-CIO v. Hodgson,
499 F.2d 467, 475 (D.C. Cir. 1974) (recognizing that substantial evidence standard of review in a
legislative- pe proceeding i onl applicable o ome dimen ion of he agenc deci ion). B
ome de ermina ion in ol e polic choice or fac al de ermina ion o m ch on he fron ier
of cien ific kno ledge ha he re emble polic de ermina ion more han fac al one .
A be I f . A , 727 F.2d at 422 (quoting Hodgson, 499 F.2d at 474). For these
de ermina ion e re pec he bo ndarie be een he legi la i e and he j dicial f nc ion,
[and] e approach o r re ie ing a k i h a fle ibili informed and haped b en i i i o
he di er e origin of he de ermina ion ha en er in o a legi la i e j dgmen made b an
agenc . 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.
App. 244
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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 doe no pre en a r e emergenc in he orkplace ha no fo nda ion in
he record and la and ignore OSHA e plana ion . 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.
E en if e a me ha OSHA ho ld ha e i ed an ETS earlier, moreo er, o hold ha
because OSHA did not act previously it cannot do so now only compounds the consequences of
he Agenc fail re o ac . Id. at 423. In Asbestos Information Association, the petitioners
challenged he Agenc mo i e in prom lga ing an ETS hen he Agenc ha kno n for
years that asbestos constitutes a serious health risk, and, in fact, has had all the data it uses to
support its . . . ac ion a hand, b ne er hele failed o ac on i . Id. The Fifth Circuit
concluded that the statutory language itself precludes a requirement that OSHA may only act on
ne informa ion beca e he Ac permi reg la ion of harmf l agen or ne ha ard ,
proving that not all regulated dangers must be new. Id. OSHA ho ld, of co r e, offer ome
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
o he orkplace, he rapid ri e o predominance of he Del a arian mean increa e in
infec io ne and ran mi ion and po en iall more e ere heal h effec . 86 Fed. Reg. a
61,409 12. OSHA also explained that its traditional nonregulatory options had been proven
inadeq a e. 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;
hi fac demon ra e appropria e ca ion and ho gh on he par of he Secre ar .
App. 245
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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 ppor OSHA concl ion ha he c rren i a ion i an emergenc , and one
that can be ameliorated by agency action.
ii. Grave Danger
Heal h effec ma con i e a gra e danger nder he OSH Ac if orker face he
danger of incurable, permanent, or fatal consequences . . . , as opposed to easily curable and
flee ing effec on heir heal h. F a. Peac G e A , I c. . U.S. De f Lab ,
489 F.2d 120, 132 (5 h Cir. 1974). The gra e danger req ired o arran an ETS i a ri k
grea er han he ignifican ri k ha OSHA m ho o prom lga e a permanen andard
under § 655(b) of the Act. See I d . U De , 448 U.S. at 640 n.45. But the ultimate
determination of what precise level of ri k con i e a gra e danger i a polic con idera ion
ha belong , in he fir in ance, o he Agenc . A be I f . A , 727 F.2d at 425
(accep ing OSHA de ermina ion ha 80 li e a ri k o er i mon h a a gra e danger).
The Fif h Circ i concl ion, nadorned b preceden , ha OSHA i req ired o make
findings of exposure or at least the presence of COVID-19 in all co ered orkplace i
simply wrong. BST Holdings, 17 F.4th at 613 (emphasis in original). If that were true, no
ha ard co ld e er ri e o he le el of gra e danger beca e a ri k canno e i eq all in e er
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 de ermina ion ha emplo ee 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.
App. 246
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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
andard if he can ho ha he 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 andard.
D C Mf . A . De f Lab , 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
he di ea e, p ing orker a heigh ened ri k of con rac ing i . Tran mi ion can occ r hen
people are in close contact with one another in indoor spaces (within approximately six feet for
a lea fif een min e ) or in indoor pace i hout adequate ventilation where small
re pira or par icle are able o remain pended in he air and acc m la e. 86 Fed. Reg. a
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 emplo ee generall hare common area like hall a ,
restrooms, lunchroom [,] and mee ing room . Id. at 61,411. Evidence cited by OSHA
3Our dissenting colleague argues that OSHA fails to satisfy
he gra e danger in he orkplace limi a ion
on i a hori beca e i doe no e abli h ha all co ered emplo ee ha e a high ri k bo h of con rac ing
COVID-19 and ffering e ere con eq ence . (Di en Op. a 49) B hi ec ion on Grave Danger e plain
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. A . De a A , 984 F.2d at 827 (holding that
OSHA is not required to proceed orkplace b orkplace ).
App. 247
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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,
mo emplo ee ho ork in he pre ence of o her people (e.g., co orker , c omer , i i or )
need o be pro ec ed. 86 Fed. Reg. a 61,412. Repor prod ced b a e p blic heal h
organizations corroborate that finding. See, e.g., id. at 61,413 (North Carolina Department of
Heal h and H man Ser ice repor ing ha n mber of ca e a ocia ed ih orkplace cl er
began increasing in several different types of work settings, including meat processing,
manufacturing, re ail, re a ran , childcare, chool , and higher ed ca ion. ); id. (Colorado
Department of Public Health & Environment reporting similar outbreaks across many types of
industries.); id. (Lo i iana Depar men of Heal h, repor ing ha [m]ore han hree quarters of
o break hro gh [A g 24, 2021] ere a ocia ed i h orkplace . ).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
erio illne , incl ding long-la ing effec on heal h, (no named long COVID ). Id. at
61,410. I ha al o killed o er 725,000 people in he Uni ed S a e in le han o ear . 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
gro p ; b on he hole orking age American (18-64 years old) now have a 1 in 14 chance
of hospitalization when infected with COVID-19. Id. at 61,410. The e eri i al o likel
exacerbated by long-standing healthcare inequities experienced by members of many racial and
4O r di en ing colleag e arg e ha OSHA fail o a i f he gra e danger in he orkplace limi a ion
on its authority because the Secretary did not specify how many employees would contract the virus at work and
in ead calc la ed he n mber 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.
App. 248
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economic demographic . 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
herefore nei her ea il c rable and flee ing nor i he ri k of de eloping erio disease
speculative. See Fla. Peach Growers, 489 F.2d at 132; D C Mf . A , 489 F.2d at 106.
OSHA f r her e ima ed ha he andard o ld a e o er 6,500 orker li e and
prevent over 250,000 hospitalizations over the course of the next six mon h . Id. at 61,408.
This well exceeds what the Fifth Circuit previously found to present a grave danger. See
A be I f .A , 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
he co r e per i e doe no lie in echnical ma er . Pub. Citizen Health Rsch. Grp. v. Tyson,
796 F.2d 1479, 1495 (D.C. Cir. 1986). [I] i no infreq en ha he a ailable da a do no e le
a regulatory issue, and the agency must then exercise its judgment in moving from facts and
probabili ie on he record o a polic concl ion. Id. (quoting M Ve c e Mf . A .
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
herefore canno a ha OSHA ac ed improperl in ligh of i clear reliance on a bod of
rep able cien ific ho gh . I d . U De ., 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
App. 249
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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 dela in prom lga ing he ETS i e idence ha no gra e danger e i . A e plained,
however, OSHA provided i rea oning for he dela . When he pandemic began, cien ific
e idence abo he di ea e and a o mi iga e i ere nde eloped. 86 Fed. Reg. a 61,429.
At that point, OSHA chose to focus on nonregulatory options, and crafted workplace guidance
ba ed on he condi ion and informa ion a ailable o he agenc a ha ime, incl ding ha
accine ere no e a ailable. Id. at 61,429 30. The voluntary guidance, however, proved
inadeq a e, and a emplo ee re rned o orkplace he rapid rise to predominance of the
Del a arian mean increa e in infec io ne and ran mi ion and po en iall more e ere
heal h effec . 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 of Heal h & H man Ser ., https://www.michigan.gov/coronavirus/0,9753,7-406-
98163_98173_ 102057---,00.html.
6TN Dep of Heal h, https://www.tn.gov/content/dam/tn/health/documents/cedep/novel-
coronavirus/Critical IndicatorReport.pdf
7Wa h. Dep of Heal h, 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.
App. 250
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contracting COVID-19, ppor OSHA concl ion ha he ime a ripe for OSHA o address
the ongoing danger in the workplace through an ETS. More importantly, we are not to second
g e ha he Agenc con ider a ri k or h of Agenc ac ion beca e ha i a polic
consideration that belongs, in the first instance to the Agency. A be I f .A , 727 F.2d at
425. Rel ing on he hi or of he pandemic, OSHA e plained ha he agenc canno a me
ba ed on pa e perience ha na ion ide ca e le el ill no increa e again. 96 Fed. Reg. a
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 bod of rep able cien ific ho gh , OSHA ma e con er a i e a mp ion in
interpreting the data . . . , ri king error on he ide of o erpro ec ion ra her han nderpro ec ion.
I d .U De , 448 U.S. at 656.
iii. Necessity
To i e an ETS, OSHA i al o req ired o ho ha he ETS i nece ar o pro ec
emplo ee from he gra e danger. 29 U.S.C. 655(c)(1). Thi andard i more demanding
han he rea onabl nece ar or appropria e andard applicable to permanent standards. See
id. § 652(8); ee a I d . U De , 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
App. 251
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beca e he ETS pro ec ion afforded o orker ho ld o eigh he economic con eq ence
o he reg la ed ind r . A be I f .A , 727 F.2d at 423.
Some Petitioners argue he ord nece i manda e ha OSHA andard ma e
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
ackno ledged hi prac ical reali , e plaining ha ETS andard ma nece aril be
somewhat general . . . . It cannot be expected that every procedure or practice will be strictly
nece ar a o e er b ance, pe of e, or plan opera ion. Dry C Mf . A , I c.,
486 F.2d a 105. OSHA need onl demon ra e ha he ol ion i propo e i nece ar o
alleviate a gra e ri k of orker dea h d ring [ he ETS ] i mon h erm. A be I f .A ,
727 F.2d at 427 (emphasis added).
The dissent disagrees, contending that the Secretary must rule out alternatives to show
h hi propo ed mean are indi pen able, poin ing o Asbestos Information Association.
(Dissent Op. at 44) B in ha ca e, he Fif h Circ i fo nd ha OSHA determination of
nece i for he propo ed ETS a nderc b i e i ing reg la ion hro gh hich m ch of
he claimed benefi co ld be ob ained. 727 F.2d a 427. The Fif h Circ i did no req ire ha
OSHA rule out every plausible alternative in devising its ETS because the critical question was
he her OSHA c rren reg la ion ere fficien o addre he problem. See id. To answer
ha q e ion, he Secre ar here ca aloged OSHA ac ion in ol ing 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-rela ed complain con in ed o po r in, gge ing a lack of
wide pread 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
a i fie he Secre ar obliga ion.
App. 252
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Turning to assess the remaining evidence ppor ing OSHA nece i 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
emplo er in heir niq e orkplace e ing ma be be ituated to understand their workforce
and ra egie ha ill ma imi e orker pro ec ion hile minimi ing orkplace di r p ion .
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
po er of accine o afel pro ec indi id al , incl ding from he Del a arian . Id. at 61,432,
61,450. E en i e e idence ci ed b OSHA ho ha accina ion red ce[ ] he pre ence and
severity of COVID-19 ca e in he orkplace, and effec i el en r[e ] ha orker 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
e ing i e en ial beca e SARS-CoV-2 infection is often attributable to asymptomatic or
pre- mp oma ic ran mi ion. Id. at 61,438 (citing studies). And wearing a face covering
pro ide an addi ional la er of pro ec ion, de igned o red ce e po re o he re pira or
droplets of co-workers and others[, and] . . . o ignifican l red ce he earer abili o pread
he ir . 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
co ering ill f r her mi iga e he po en ial for n accina ed workers to spread the virus at the
orkplace. Id. at 61,439. Based on the evidence relied on by OSHA, these measures will
App. 253
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pro ec orker from he gra e danger pre en ed b 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. Na Ga & Feed A . Occ a a Safe & Hea Ad .,
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, he ETS ill reach he large facili ie , here he
most deadly outbreaks of COVID-19 can occ r. 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.
Pe i ioner con end, rel ing on he Fif h Circ i deci ion, ha he nece i of he ETS
is undermined by the fac ha i i bo h o erincl i e and nderincl i e. Nei her
ob er a ion arran a a . OSHA ma lean on he ide of o erpro ec ion ra her han
nderpro ec ion hen prom lga ing an ETS. I d . U De , 448 U.S. at 656.9 And
OSHA i no req ired o proceed orkplace b orkplace, A . De a A , 984 F.2d at 827,
in i ETS nor o ld i be e pec ed o cond c on-the- po in e iga ion , Dry Color Mfrs.
A I c., 486 F.2d at 102 n.3. To expect otherwise of OSHA would belie the whole point of an
9The dissent contends that o r ci a ion i
inappo i e beca e i did no re ie an emergenc standard and
refer o he Secre ar in erpre a ion of da a nderl ing a ri k a e men . (Di en Op. a 47) The language cited,
ho e er, addre e he her OSHA e idence ppor ing i e ima ion of a ri k, hich a he ba i for he
standard, was supported by substantial evidence. I d . U De , 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).
App. 254
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emergency emporar andard, hich demand ha OSHA ac q ickl o pro ide immedia e
pro ec ion o orker facing a gra e danger. Id. at 105. OSHA explored the dangers in varied
workplaces and industries and concluded tha emplo ee can be e po ed o he ir in almo
an ork e ing and ha emplo ee ro inel hare common area like hall a , re room ,
l nchroom [,] and mee ing room and are a ri k of infec ion from con ac i h co orker ,
clients, or members of he p blic. 86 Fed. Reg. a 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
orker ha are a le er ri k of dea h han o her o erlook OSHA rea oning. 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 ide arie of ork e ing acro all
ind rie h co n eling for he broad andard. 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. a 61,513 ( OSHA ha e he hre hold for co erage
based primarily on administrative capacity for purposes of protecting workers as quickly as
po ible. ); id. a 61,512 ( gge ing ha larger emplo er are more likel o ha e man
employees ga hered in he ame loca ion and ha e larger and longer o break ).
App. 255
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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 i no req ired o iden if he op imal hre hold
with pinpoint precision. It is only required to identify the standard and explain its relationship to
he nderl ing reg la or concern . Na S gS F d. . 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) (no ing ha he go ernmen need no addre all
a pec of a problem in one fell oop ). Co r are generall n illing o re ie line-drawing
performed by the [agency] unless a petitioner can demonstrate that lines drawn . . . are patently
unreasonable, ha ing no rela ion hip o he nderl ing reg la or 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 ETS readil ho a rela ion hip o he 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 F g g I d . A , 773 F.2d at 1454;
United Steelworkers of Am., 647 F.2d at 1309 10 (D.C. Cir. 1980).
T rning o he co anal i , OSHA i no req ired o cond c a formal co -benefit
anal i before i ing an ETS. A be I f .A , 727 F.2d at 423 n.18 (reasoning that it is
nlikel ha he agenc o ld ha e ime o cond c ch an anal i in he con e of an
emergenc ). Congre recogni ed ha OSHA andard o ld impo e co ,b placed he
benefit of worker health above all other considerations save those making attainment of this
benefit unachie able. 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
andard i economicall fea ible if he co i impo e do no hrea en ma i e di loca ion
to, or imperil he e i ence of, he ind r . Am. Iron & Steel Inst. v. Occupational Safety
App. 256
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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 p hi in o per pec i e, if he a erage 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-mon h 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
o compl i h OSHA lead e po re andard o be be een $32 million and $47 million).
OSHA anal i , moreo er, doe no con ider he economic harm a b ine ill ndergo if i i
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 cce for he challenge again OSHA ba e for i ing he 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 Pe i ioner rai e challenge regarding religio liber . The ETS a e , if he accina ion, and/or
testing for COVID-19, and/or wearing a face covering conflicts with a sincerely held religious belief, practice or
ob er ance, a orker ma be en i led o a rea onable accommoda ion. 86 Fed. Reg. a 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.
App. 257
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i. Commerce Clause
First, Petitioners raise challenges to the ETS under the Commerce Clause, directing us to
he Fif h Circ i concl ion ha he ETS likel e ceed he federal go ernmen a hori
under the Commerce Clause because it regulates noneconomic inactivity that falls squarely
i hin he S a e police po er. 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
rea oned ha [a] per on choice o remain n accina ed and forego reg lar e ing i
noneconomic ac i i , and fall i hin he S a e police po er. Id. On that basis, the stay
opinion mmaril concl ded ha beca e he ETS commandeer emplo er o compel
ac i i ha fall i hin he S a e police po er, i far e ceed[ ] c rren con i tional
a hori . 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. a 550 ( The po er o regulate commerce
pre ppo e he e i ence of commercial ac i i o be reg la ed. ). The ETS reg la e
economic activity by regulating employers.
I ha long been nder ood ha reg la ing emplo er i i hin Congre reach nder
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
pre en he prod c ion of good for in er a e 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 e of commerce po er o afeg ard he righ of emplo ee o elf-organization
App. 258
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and to select representatives of their own choosing for collective bargaining or other mutual
pro ec ion i ho re rain or coercion b heir emplo er ). The e ca e recogni e, for e ample,
ha , a per on choice o di crimina e again ano her ba ed on race i noneconomic ac i i ,
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
di crimina ion b ho el and mo el impede in er a e ra el ).
Tha principle a a he hear of he S preme Co r deci ion in NLRB v. Jones &
Laughlin Steel, 201 U.S. 1 (1927). There, the Court emphasized that to determine the Commerce
Cla e applicabili , e foc on he effec pon commerce, no he o rce of he inj r , 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 na ional cale, moreo er, Congre ma
pro ec in er a e commerce from paral [ i ]. Id. at 41. COVID-19 paral ing effec 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
con idered challenge o he Affordable Care Ac indi id al manda e. 567 U.S. a 539.
Cri icall , and fa al o he Fif h Circ i poin , he Affordable Care Ac con ain o epara e
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 Circ i con end ha he ETS fall q arel i hin he S a e
App. 259
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police po er . 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 ac empo ering he S a e con r c ion of a dam ha ob r c ed an in er a e
alk a i no rep gnan o he po er o reg la e commerce in i dorman a e ). To be re,
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 ha nonappro ed a e reg la ion of occ pa ional afe and heal h
issues for which a federal standard i in effec i impliedl preemp ed b OSHA andard).
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
Rel ing on he Fif h Circ i deci ion, Pe i ioner ca con i ional do b on he ETS
b q e ioning Congre delegation of authority to OSHA when it passed the OSH Act. The
Fif h Circ i c r oril concl ded ha Congre canno a hori e a orkplace afe
administration in the deep recesses of the federal bureaucracy to make sweeping pronouncement
on matters of p blic heal h affec ing e er member of ocie in he profo nde of a . BST
Holdings, 17 F.4th at 611. That contention never specifies which provision of the OSH Act is an
App. 260
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improper delegation. We therefore construe its analysis in line with the Peti ioner arg men
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
a ed ha , [ ]he nondelega ion doc rine bar Congre from ran ferring i legi la i e po er o
ano her branch of Go ernmen . 139 S.C . 2116, 2121 (2019) (pl rali opinion). B he
Con i ion doe no den [] o he Congre he nece ar re o rce of fle ibili and
prac icali [ ha enable i ] o perform i f nc ion[ ]. Id. at 2123 (alterations in original)
(quoting Yakus v. United States, 321 U.S. 414, 425 (1944)) (alterations in original). To the
con rar , Congre ma confer b an ial di cre ion on e ec i e agencie o implemen and
enforce he la . Id. (citing Mistretta v. United States, 488 U.S. 361, 372 (1989)). A statutory
delega ion i herefore con i ional a long a Congre la [ ] do n b legi la i e ac an
intelligible principle to which the person or body authorized to [exercise the delegated authority]
i direc ed o conform. Id. (quoting Mistretta, 488 U.S. at 372) (alterations in original). The
ar ing and of en ending poin for he anal i i a or in erpre a ion : We m con r [e]
he challenged a e o fig re o ha a k i delega e and ha in r c ion i pro ide and
hen decide he her he la fficien l g ide e ec i e di cre ion o accord i h Ar icle 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
reg la e in he p blic in ere , Na B ad. C . . U ed S a e , 319 U.S. 190, 216 (1943), to
e fair and eq i able price , Yakus, 321 U.S. at 427, and to issue air quality standards
req i i e o pro ec he p blic heal h, W a . A . T c g A , 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
end he inq ir . OSHA a or a hori oi e andard i fo nd in 29 U.S.C. 655.
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Specific authorization is in § 655(c)(1) and requires the Secretary to promulga e emergenc
emporar andard , hen he de ermine ha emplo ee are in gra e danger from e po re
oa orkplace ha ard and ha he andard i nece ar o pro ec he emplo ee from ch
danger. As shown above, it is well-established that the cope of he OSH Ac and OSHA
authority include infectious diseases in the workplace, even when those diseases also exist
o ide he orkplace. Therefore, Congre applied an in elligible principle hen i direc l
authorized OSHA to exercise this delegated authority in particular circumstances. The Supreme
Co r long ago recogni ed hi a hori : The [Occ pa ional Safe and Heal h] Ac delega e
broad a hori o he Secre ar o prom lga e differen kind of andard . I d . U De ,
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 meri a a , Pe i ioner bear he b rden o demon ra e an irreparable inj r ; impl
ho ing ome po ibili of irreparable inj r fail o ai f he econd fac or. 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
concl ding ha a a ill do OSHA no harm ha oe er. BST Holdings, 17 F.4th at 618.
We engage in o r o n balancing of he par ie 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
App. 262
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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 job . In a con er a i e e ima e, OSHA find ha he ETS ill a e o er 6,500 orker
li e and pre en o er 250,000 ho pi ali a ion in j i mon h . 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 he Go ernmen mo ion and DISSOLVE the
stay issued by the Fifth Circuit.
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_________________
CONCURRENCE
_________________
GIBBONS, Circ i J dge, conc rring. I agree ha he go ernmen mo ion o di ol e
the stay should be gran ed and conc r f ll in J dge S ranch opinion. I ri e epara el o no e
the limited role of the judiciary in this dispute about pandemic policy. Petitioners and various
opinion di c a leng h ho OSHA co ld ha e handled he pandemic impac on places of
employment differently. Some of the writings include sweeping pronouncements about
con i ional la and he cope of OSHA a or a hori . M ch of hi ri ing i
untethered from the specific facts and issues presented here and overlooks the limited nature of
our role.
Rea onable mind ma di agree on OSHA approach o he pandemic, b e do no
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-
branche . [F]ederal j dge 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
, o r em doe no permi agencie o ac nla f ll e en in p r i of de irable end .
A a. A f Rea . De f Hea &H . Se ., 141 S. Ct. 2485, 2490 (2021). The
majori heme i ha q e ion of heal h cience and polic lie be ond he j dicial 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 emergenc r le
pending final review.
I.
The majority opinion describes the emergency rule at issue here as permitting employers
o de ermine for hem el e ho be o minimi e he ri k of con rac ing COVID-19 in their
orkplace . Maj. Op. a 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 req ire hem o e abli h, implemen , and enforce a ri en manda or
accina ion polic . 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
bcon rac or alread bjec o a accine manda e and heal hcare orker bjec o OSHA J ne 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
addi ion, nei her he Uni ed S a e . . . [n]or an S a e or poli ical bdi i ion of a S a e i a co ered emplo er.
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. S ch plan m be a lea a effec i e 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). Emplo ee m be f ll accina ed, nle he q alif 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- accina ion polic ill enjo
ad an age , incl ding fe er admini ra i e b rden[ ], han 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. Thi , de pi e he fac ha OSHA
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. a 61,532 (no ing OSHA ha commonl req ired emplo er o pa for
protective equipment); 29 C.F.R. § 1910.1030(d)(3)(i), (f)(1)(ii) (Hepatitis B equipment and
e ing a no co ); id. § 1910.1018(j)(1), (n)(1)(ii) (same for arsenic); id. § 1910.1001(h)(1),
(l)(1)(ii)(A) (same for asbestos); Sec f Lab. . Be e Hea ca e-Hillview, 541 F.3d 193,
200 01 (3d Cir. 2008) (OSHA in erpre a ion of a no co incl de compen a ion for e ing
time and travel expenses). Indeed, OSHA required employers to provide COVID-19 e a no
co o emplo ee nder i earlier heal hcare ETS. See 29 C.F.R. § 1910.502(l)(1)(ii). OSHA
was candid about why it deviated from its normal rule: P ing he on on emplo ee ill
provide a financial incentive . . . o be f ll accina ed. 86 Fed. Reg. a 61,437. The r le, in
sum, is a mandate to vaccinate or test.
One more background point: The purpose of the mandate is to protect unvaccinated
people. Id. a 61,419. The r le premi e i ha accine ork. Id. And so, OSHA has
e plained ha he r le i no abo pro ec ing he accina ed; he do no face gra e 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 ha e le ied erio , and aried, charge again he manda e 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 T ge L , LLC . U.S. De fH . & U b. De ., 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
affec ing he people heal h and afe i for a a e legi la re, or ome ime Congre , o pa
one in o la . Beca e he legi la re ield he formidable po er of pre crib[ing] he r le by
hich he d ie and righ of e er ci i en are o be reg la ed, i i , b de ign, he branch of
go ernmen mo re pon i e o he ill of he people. T ge L , LLC . U.S. De f
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)).
B here i a orkaro nd. In he modern admini ra i e a e, man la emana e no
from Congress but from administrative agencies, inasmuch as Congress has seen fit to vest broad
r lemaking po er in he e ec i e 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
en re ha agenc r le are al o caref ll craf ed ( i h democra ic al e er ed b p blic
par icipa ion) and de eloped onl af er a e men of rele an con idera ion . Id.
Consistent with this scheme, Congress delegated to OSHA the authority to promulgate
occ pa ional afe or heal h andard[ ] ha are rea onabl nece ar or appropria e o
addre a ignifican ri k of harm in he orkplace. See I d . U De , 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
he delibera i e proce , and o i e emergenc emporar andard ha ake immedia e effec
pon p blica ion and remain effec i e for i mon h . 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
mo drama ic eapon in [OSHA ] enforcemen ar enal. A be I f . A /N. A . .
Occupational Safety & Health Admin., 727 F.2d 415, 426 (5th Cir. 1984). It is an
[e] raordinar po er ha ho ld be delica el e erci ed, and onl in ho e emergenc
i a ion hich req ire i . F a. Peac G e A , I c. . De f 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]mergenc andard are o be ed onl in limi ed i a ion and onl a
an n al re pon e o e cep ional circ m ance . (q o a ion mark omi ed)).
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.
Congre oo a ar of conferring hi a hori , repea edl e pre [ing] i concern
abo allo ing he Secre ar o ha e oo m ch po er in hi area. Indus. Union, 448 U.S. at
651. Accordingl , Congre narro l circ m cribed he Secre ar ability to use this
considerable tool. Id. Before the Secretary may issue an emergency standard, he must
de ermine[] (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 o pro ec emplo ee from ch danger. 3 29 U.S.C § 655(c)(1)
(emphases added).
So he Secre ar emergenc a hori e end no f r her han o i e emporar
standards that are (1) necessary to protect employees from (2) grave danger. And because the
Secre ar a hori i o e occ pa ional afe and heal h andard , go erning
emplo men and place of emplo men , he danger o be reg la ed m come from
3I assume here that the virus that causes COVID-19 con i e a b ance[] or agen [] de ermined o be
o ic or ph icall harmf l or a ne ha ard, i hin he meaning of § 655(c)(1). Even if so, OSHA lacked
authority to issue the rule.
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(3) e po re in he orkplace. 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
m be nece ar o pro ec emplo ee from [gra e] danger. 29 U.S.C. 655(c)(1).
Nece ar , in he legal ernac lar, i a ailoring ord. I a k ho clo el , or how loosely, a
reg la or ol ion m fi a par ic lar problem. Some ime nece ar mean impl
ef l. Necessary, Black La Dic ionar (5 h ed. 1979). In ho e in ance , he go ernmen
may impose solutions that it thinks might help the problem, even if it ends up regulating a good
deal more han i reall need o. A o her ime , ho gh, nece ar mean indi pen able.
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
nece ar , prominen l di pla ed 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
rea onabl nece ar or appropria e o addre he problem a hand. 29 U.S.C. 652(8); see
Indus. Union, 448 U.S. at 642 43. But when conferring emergency authority on the Secretary,
Congre ha ed ha do n o nece ar . An emergenc mea re m , herefore, be more
than rea onabl needf l; i m be clo er o indi pen able. Cf. McCulloch, 17 U.S. (4
Wheat.) at 413 15. And then consider context. The Supreme Court has already said that
Congre narro l circ m cribed he Secre ar a hori o i e emergenc standards.
Indus. Union, 448 U.S. a 651 & n.59. I follo ha , in hi con e e peciall , nece ar
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 emergenc andard m be more han rea onabl nece ar ; i m be e en ial. Maj.
Op. at 25. But then that word, and the concept, disappear from the analysis. What starts as a
demand for an e en ial ol ion, q ickl rn in o accep ance of an effec i e or
meaningf l[] remed , id. at 26 30; and later, acquiescence to a solution with a mere
rea onable rela ion hip o he problem, id. at 30. The majority opinion never explains why
nece ar ndergoe ch a me amorpho i .
While the majority opinion starts with the right read on the statute, the Secretary seems to
ha e mi ed hi poin al oge her. He made no finding ha he emergenc r le i nece ar in
an en e e en approaching indi pen able. We canno phold a r le ba ed on a finding he
agency never made. S.E.C. v. Chenery Corp., 318 U.S. 80, 87 (1943).
Wha he Secre ar did a i ha he agenc e i ing reg la or ool and non-
manda or g idance ere in fficien . 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 a nece ar o ol e
the problem.4 See 29 U.S.C § 655(c)(1); see also Asbestos Info., 727 F.2d at 426 27 (OSHA
failed o ho ha an emergenc andard a nece ar hen o her mean ere a ailable o
achie e he projec ed benefi . ). OSHA ne er make ha ca e. Like he majori 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
nece ar , or indi pen able, mean of c ring he ill.
4The a e req ire he Secre ar o find ha ch emergenc andard i nece ar . 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 gge ha he Secre ar d o ld be f lfilled if he found impl ha an emergenc
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, ha i a mi read. I do no read nece ar o req ire o al elimination of the
harm.
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To ill ra e ( i ho in ending o ri iali e) OSHA a k, con ider he 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
ch an approach nece ar . Wha OSHA r le a i ha accine or e for nearl he
whole American workforce will solve the problem; it does not explain why that solution is
necessary.
Bedrock principle of admini ra i e la al o ppor hi poin . I i a q in e en ial
a pec [] of rea oned deci ionmaking ha an agenc e plore common and kno n or o her i e
rea onable op ion and e plain an deci ion o rejec hem. I Lad e Ga e W e
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 o e plain incon i encie in he agenc o n da a hen he da a re ealed a
ignifican and iable and ob io al erna i e ha he agenc failed o con ider (q o ing Na
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
emporar mea re ma req ire f r her refinemen in he b eq en permanen andard, he
agenc ho ld no o erlook ho e ob io distinctions . . . that make certain regulations that are
appropria e in one ca egor of ca e en irel nnece ar in ano her. D C Mf . A .
De f Lab., 486 F.2d 98, 105 (3d Cir. 1973); see also id. at 107 (Emergency standard must
explain he al erna i e kind of reg la ion con idered b OSHA. ).
OSHA manda e applie , in ndifferen ia ed fa hion, o a a a h of American : 84
million workers, 26 million unvaccinated, with varying levels of exposure and risk. 86 Fed. Reg.
at 61,424. The b rden i on he agenc o ar ic la e ra ionall h he r le ho ld appl oa
large and di er e cla . 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
App. 272
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and Testing, 86 Fed. Reg. 61402
for he lea . The go ernmen o n da a ho ha n accina ed orker be een he age 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
he Secre ar o gi e d e regard o he need for andard for par ic lar ind rie and pe
of orkplace or ork en ironmen . 29 U.S.C. 655(g). And OSHA acknowledges that
dea h ra e are higher in [c]er ain occ pa ional ec or , 86 Fed. Reg. a 61,415; e i r le
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 a er ion. Fir , e en an emergenc andard m
con ider ob io di inc ion among ho e i reg la e . Dry Color, 486 F.2d at 105. Here,
here are man , none reflec ed in he emergenc r le. Second, he agenc claim of emergenc
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 he propo i ion ha OSHA ma lean on he ide of o erpro ec ion ra her
than underpro ec ion hen prom lga ing 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
q o ed lang age refer o [ing] con er a i e a mp ion in in erpre ing he da a nderl ing
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;
App. 273
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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
agenc ord , he bigge hrea o emplo ee in OSHA more han 50- ear hi or .
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, he Secre ar canno ho ha hi ol ion i nece ar ; nor i he able o
r i e he req iremen of hard look re ie . See Asbestos Info., 727 F.2d at 421 (When
re ie ing an emergenc andard, em ake a harder look . . . than we would if we were
reviewing the action under the more deferential arbitrary and capricious standard applicable to
agencie go erned b he [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
ha he manda e a nece ar . B here are al o ignifican concern i h OSHA
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. Gra e danger comprises two meanings. First, severity: A gra e
danger i a ri k of inc rable, permanen , or fa al con eq ence o orker . 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.
B he a or concep of danger, or ri k, al o carrie a econd conno a ion the likelihood
App. 274
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and Testing, 86 Fed. Reg. 61402
of its occurrence. See Asbestos Info., 727 F.2d a 424 (no ing gra i incl de he number of
orker likel o ffer [ e ere] con eq ence ); Fla. Peach Growers, 489 F.2d at 132
(mea ring danger rela i e o he ma of agric l ral orker in con ac i h rea ed 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. S b an ial e idence i ha hich a rea onable mind migh accep
a adeq a e o ppor a concl ion. 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 accina ed orker i in gra e danger, herea all unvaccinated
orker are. 86 Fed. Reg. a 61,434, 61,419. B he go ernmen o n da a re eal hat 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 he e concl ion m be rong; ei her a i a problem for OSHA r le.
In the Workplace. OSHA a hori e end onl o far as Congress provides. And
Congre ha clearl marked he perime er of OSHA a hori : the workplace walls. See
29 U.S.C. § 651(a) ( ork i a ion ); id. § 651(b) ( occ pa ional afe and heal h andard )
( orking condi ion ); see also Steel Joint Inst. v. Occupational Safety & Health Admin.,
287 F.3d 1165, 1167 (D.C. Cir. 2002) ( [T]he Ac a hori e OSHA o reg la e onl he
emplo er cond c a he ork i e. ).
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
grocer ore, o name a fe . So ho can OSHA reg la e an emplo ee e po re o i ?
5Hospitalization rates corresponding to these age groups is not readily available from the CDC.
App. 275
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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
orkplace). S re. B one e po re o fire ma be ea il differen ia ed b loca ion, and
OSHA has heretofore respected that its regulatory authority extends no further than the
workplace walls. In Industrial Union, for e ample, he Co r no ed ha al ho gh [ ]he en ire
pop la ion of he Uni ed S a e i e po ed o mall q an i ie of ben ene in he 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 Occ pa ional Noi e E po re andard
beca e orker faced ained noi e of grea in en i a ork, hich did no e i a ho e
levels outside the workplace. F g g I d . A v. Sec of Lab., 773 F.2d 1436, 1442 44
(4th Cir. 1985) (en banc) ( The ha ard i iden ified a ained noi e of grea in en i -85 db
and above. Non-occupational noise of that intensity sustained over a period of eight hours each
da i hard o imagine. ).
Ye OSHA admi ha i canno ae i h preci ion he o al n mber of orker in o r
nation who have contracted COVID-19 a ork. 86 Fed. Reg. a 61,424. And i ha no
identified any particular rate or risk of workplace exposure to COVID-19. So instead OSHA
de ermined ha each of he 26 million n accina ed orker are in gra e danger ba ed on
c rren mor ali da a ho [ing] ha n accina ed people of orking age ha e 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 gra e danger and nece i finding m be ba ed on e idence of actual,
prevailing [workplace] conditions, i.e., c rren le el of emplo ee e po re. UAW v. Donovan,
590 F. Supp. 747, 751 (D.D.C. 1984).
The ri k he Secre ar calc la ed o ppor hi gra e danger finding a in no a
tied to any workplace. Instead, he calculated the risk of being a person of orking age in
America. 86 Fed. Reg. a 61,424. Indeed, in OSHA e e , he ri k o an emplo ee ho ar a
App. 276
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job oda i no more gra e han i a e erda , before he en ered he orkforce; 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 a an occ pa ional afe and heal h andard[]. 29 U.S.C.
§ 651(b)(3). And i i hard o q are i h Congre codified mi ion a emen for he
Agency: o pre en per onal inj rie and illne e ari ing o of ork i a ion . Id. § 651(a).
And what of the solution? Here, OSHA has ventured into entirely new territory. An
a hori o pro ec emplo ee from a gra e danger enco n ered in he orkplace, 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
ch preca ion a home o ld a e man emplo ee li e .
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.
Accordingl , I q e ion he her he Secre ar can ho ha OSHA ri k a e men
and solution are tied to its authority to protect employees against grave danger in the
workplace.
App. 277
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2. Major Questions Doctrine
If there were doubt, the major questions doctrine tells us how to respond. Congress must
peak clearl if i i he o a ign o an agenc deci ion of a economic and poli ical
ignificance. 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
agenc ddenl di co er in a long-extant statute an unheralded power to regulate a significant
por ion of he American econom . Id. (quotation marks omitted).
OSHA ha ne er i ed an emergenc andard of hi cope. Each of hi r le fe
predecessors addressed discrete problems in particular industries. See 48 Fed. Reg. 51,086,
51,087 93 (No . 4, 1983) ( arge ing orkplace here a be o i handled, pecificall
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 wi h he highe e po re o acr loni rile); 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- e manda e acro all ind rie 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
App. 278
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does what the Supreme Court requires in such circumstances: speak with e ceedingl clear
lang age. A a. A f Rea , 141 S. Ct. at 2489.
The majority deems the major questions doctrine inapplicable, first because, in its eyes,
OSHA a hori o nder ake a na ion ide accine-or- e manda e i nambig o . 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
imilar in kind and call ha cope. B no ma er ho man ime OSHA ha reg la ed
discrete illnesses in particular workspaces, this emergency rule remains a massive expansion of
the scope of its authority. In Brown & Williamson, he FDA had been reg la ing dr g and
de ice for 58 ear . 529 U.S. a 125. And reg la ing nico ine eemed o fi in he FDA
wheelhouse. See id. a 127. None hele , he Co r denied he FDA a hori o make a
polic deci ion of ch economic and poli ical magni de e en one in he agenc ken, and
e en ho gh obacco a perhap he ingle mo ignifican hrea o p blic heal h in he
Uni ed S a e a he ime.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 A a. A f Rea , 141 S. Ct. at 2486. The CDC
had imposed an eviction moratorium for any counties with high levels of COVID-19
ran mi ion, ci ing i a hori in he P blic Heal h Ac o make ch reg la ion a . . . are
necessary to prevent the introduction, transmission, or spread of communicable diseases from
foreign co n rie . Id. a 2487. Deciding ha a challenge o he mora ori m a ir all
cer ain o cceed on he meri , he Co r fo nd ha e en if he pro i ion co ld be read ha
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-ga reg la ion a oma icall riggered permi ing req iremen a an enormo
and ran forma i e e pan ion in a hori ha riggered 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.
App. 279
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and Testing, 86 Fed. Reg. 61402
a , he heer cope of he CDC claimed a hori belied he go ernmen in erpre a ion.
Id. at 2489.
The majority gives short shrift to this very recent precedent, calling the major questions
doc rine a eldom-used . . . exception to Chevron deference. Maj. Op. a 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 he ca e. The majori pro e ha he doc rine i hardl a
model of clari and ha economic and poli ical ignificance i ndefined. Id. Maybe so.
Yet it is hard to think of a more apt comparison than the one the Supreme Court just gave us to
follo . Finding i o be a po er of a economic and poli ical ignificance, he Co r
empha i ed ha he CDC mora ori m co ered 80% of he co n r , incl ding between 6 and
17 million tenants, all o comba [] he pread of COVID-19. A a. A f Rea , 141 S.
Ct. at 2489 90. OSHA r le co er o-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
i no clear on i face ha OSHA accina e-or-test mandate covering most of the country is
significant, then Alabama Association of Realtors tells us it is.
Finall , he majori rie o e cape he doc rine b claiming ha he Secre ar a hori
is carefully circumscribed by the requirements in § 655 ha he r le be nece ar o comba a
gra e danger, and ha OSHA ha honored ho e parame er b ing i po er infreq en l .
Maj. Op. at 16. Two short responses are in order. One, the provision in Alabama Association of
Realtors was similarly circumscribed; the CDC co ld ac onl hen i a nece ar o
pre en he pread of comm nicable di ea e, and i had rarel . . . in oked i po er.
141 S. Ct. at 2487. Two, the fact that § 655 narro l circ m cribe[ ] OSHA a hori ,
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.
App. 280
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and Testing, 86 Fed. Reg. 61402
See Whitman v. Am. T c g A , 531 U.S. 457, 475 (2001) ( [T]he degree of agenc
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
e ample, one pe i ioner, Oberg Ind rie , a ha i ill inc r more han $22 million in lo
re en e per ear, and ha he accina e-or- e manda e ill imperil Pe i ioner business
going for ard gi en ignifican labor marke hor age . Docke No . 21-7000, 21-4112,
Motion for Emergency Stay at 2. Currently, the company has 21 open positions and, according
App. 281
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o Oberg, die ho ha a lea e en million affec ed orkers report that they definitely
ill no ge he accine. Id. The vaccinate-or-test mandate will exacerbate these shortages,
i h Oberg e ima ing ha i ill lo e 200 emplo ee approximately 30% of its existing
orkforce. 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
e eri of pe i ioner harm . Of co r e he record i ilen a o pe i ioner concern , gi en
that the emergency standard circumvents any public input. And while OSHA says its projected
co are m ch lo er han pe i ioner , he projec ed co are no 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-mon h dela be een he Pre iden manda e anno ncemen and he
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 M c ga Hospitals Near Breaking Point: We Ca 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
e en reg la e for he ake of he accina ed; he are no in gra e danger. In ead, he manda e
is aimed directly at protecting the unvaccinated from their own choices. Vaccines are freely
App. 282
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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 o ld den OSHA mo ion o di ol e he a .
App. 283
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