Court filing
Defendants' motion to dismiss — White Coat Waste v. HHS
Record facts
| Court | UNITED STATES DISTRICT COURT |
|---|---|
| Filed | 2022-09-20 |
UNITED STATES DISTRICT COURT · No. 1:22-cv-00006-CJN · Doc. 21 · 2022-09-20 · Docket on CourtListener
Summary
Defendants' motion to dismiss in White Coat Waste Project, Inc. v. U.S. Department of Health and Human Services, Civil Action No. 22-0006 (CJN), filed September 20, 2022 as Document 21 in the U.S. District Court for the District of Columbia. The U.S. Department of Health and Human Services and the National Institutes of Health move to dismiss the amended complaint under Fed. R. Civ. P. 12(b)(1) and 12(b)(6). The motion argues that the plaintiff, a taxpayer watchdog organization, lacks organizational, representational, informational and procedural standing under Article III, and that its claims fall outside the zone of interests of the Public Health Service Act. The suit challenges guidance issued under Section 495 of that Act, 42 U.S.C. § 289d, that allows foreign grant applicants to obtain an animal welfare assurance without an Institutional Animal Care and Use Committee.
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UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
WHITE COAT WASTE PROJECT, INC.,
Plaintiff,
v.
Civil Action No. 22-0006 (CJN)
U.S. DEPARTMENT OF HEALTH AND
HUMAN SERVICES, et al.,
Defendants.
DEFENDANTS’ MOTION TO DISMISS
Defendants the U.S. Department of Health and Human Services and the National
Institutes of Health (collectively, “Defendants”), by and through undersigned counsel,
respectfully move to dismiss the Complaint filed by the White Coat Waste Project, Inc.
(“Plaintiff”) pursuant to Federal Rules of Civil Procedure (“Rules”) 12(b)(1) and 12(b)(6).
The Complaint is subject to dismissal as Plaintiff lacks Article III standing to bring its
claims under the Administrative Procedure Act (“APA”). Specifically, Plaintiff lacks
organizational and representational standing to challenge the agency policies and guidance at
issue. Additionally, Plaintiff fails to allege a deprivation of information that they are entitled to
receive by statute. For these same reasons, Plaintiff also fails to adequately plead procedural
standing for its alternative claim for relief. Finally, Plaintiff fails to state a claim under the APA
because it fails to assert an interest that is protected by the statute at issue.
A memorandum of points and authorities accompanies this motion. A proposed form of
order is also included.
Case 1:22-cv-00006-CJN Document 21 Filed 09/20/22 Page 1 of 27
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Dated: September 20, 2022
Respectfully submitted,
MATTHEW M. GRAVES
D.C. Bar No. 481052
United States Attorney
BRIAN P. HUDAK
Chief, Civil Division
By:
/s/ Michael E. Yohannan
MICHAEL E. YOHANNAN
Pennsylvania Bar Number 307575
Special Assistant United States Attorney
U.S. Attorney’s Office, Civil Division
601 D Street, N.W.
Washington, D.C. 20530
Tel: (202) 815-8969
Michael.Yohannan@usdoj.gov
Counsel for Defendants
Case 1:22-cv-00006-CJN Document 21 Filed 09/20/22 Page 2 of 27
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
WHITE COAT WASTE PROJECT, INC.,
Plaintiff,
v.
Civil Action No. 22-0006 (CJN)
U.S. DEPARTMENT OF HEALTH AND
HUMAN SERVICES, et al.,
Defendants.
MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF
DEFENDANTS’ MOTION TO DISMISS
MATTHEW M. GRAVES
United States Attorney
BRIAN P. HUDAK
Chief, Civil Division
MICHAEL E. YOHANNAN
Special Assistant United States Attorney
U.S. Attorney’s Office for the District of Columbia
September 20, 2022
Case 1:22-cv-00006-CJN Document 21 Filed 09/20/22 Page 3 of 27
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TABLE OF CONTENTS
BACKGROUND ............................................................................................................................ 3
A. The Animal Welfare Assurance Requirement of the Public Health Service Act ............... 3
B. The Instant Lawsuit............................................................................................................. 5
STANDARD OF REVIEW ............................................................................................................ 7
ARGUMENT .................................................................................................................................. 8
I. PLAINTIFF LACKS ARTICLE III STANDING .............................................................. 8
A. Plaintiff Fails to Establish Organizational Standing…………………………...9
B. Plaintiff Fails to Establish Representational Standing………………………..11
C. Plaintiff Fails to Establish Informational Standing…………………………...13
D. Plaintiff Fails to Establish Procedural Standing……………………………....15
II. PLAINTIFF FAILS TO STATE A CLAIM UNDER THE ADMINISTRATIVE
PROCEDURE ACT .......................................................................................................... 17
CONCLUSION ............................................................................................................................. 19
Case 1:22-cv-00006-CJN Document 21 Filed 09/20/22 Page 4 of 27
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TABLE OF AUTHORITIES
Cases
Page(s)
Abigail All. for Better Access to Dev. Drugs v. Eschenbach,
469 F.3d 129 (D.C. Cir. 2006) ................................................................................................ 10
Allen. v. Wright,
468 U.S. 737 (1984) ............................................................................................................... 17
Animal Legal Defense Fund, Inc. v. Espy,
23 F.3d 496 (D.C. Cir. 1994) ............................................................................................ 17-18
Ariz. Christian Sch. Tuition Org. v. Winn,
563 U.S. 125 (2011) ................................................................................................................. 8
Ashcroft v. Iqbal,
556 U.S. 662 (2009) ............................................................................................................. 7-8
Ass’n of Data Processing Serv. Orgs, Inc. v. Camp,
397 U.S. 150 (1970) ............................................................................................................... 17
Ass’n of Flight Attendants-CWA,
564 F.3d 462 (D.C. Cir. 2009) ................................................................................................ 11
Bell Atl. Corp. v. Twombly,
550 U.S. 544 (2007) ................................................................................................................. 8
Citizens for Responsibility & Ethics in Wash. (“CREW”) v. U.S. Off. of Special Counsel,
480 F. Supp. 3d 118 (D.D.C. 2020) .................................................................................... 9-10
Clapper v. Amnesty Int’l,
568 U.S. 398 (2013) ................................................................................................................. 8
Ctr. for Law & Educ. v. Dep’t of Educ.,
396 F.3d 1152 (D.C. Cir. 2005) ........................................................................... 8-9, 11-12, 16
Ctr. for Responsible Sci. v. Gottlieb,
346 F. Supp. 3d 29 (D.D.C. 2018) .......................................................................................... 10
Dominguez v. UAL Corp.,
666 F.3d 1359 (D.C. Cir. 2012) ................................................................................................ 8
Equal Rights Ctr. v. Post Props.,
633 F.3d 1136 (D.C. Cir. 2011) ................................................................................................ 9
Fed. Election Comm'n v. Akins,
524 U.S. 11 (1998) ............................................................................................................ 14,18
Food & Water Watch v. Vilsack
808 F.3d 905 (D.C. Cir. 2015) ........................................................................................... 9-10
Case 1:22-cv-00006-CJN Document 21 Filed 09/20/22 Page 5 of 27
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Friends of Animals v. Ashe,
174 F. Supp. 3d 20 (D.D.C. 2016) .......................................................................................... 11
Friends of Animals v. Jewell (Friends of Animals I),
824 F.3d 1033 (D.C. Cir. 2016) ........................................................................................ 13, 15
Friends of Animals v. Jewell (Friends of Animals II),
828 F.3d 989 (D.C. Cir. 2016) .................................................................................... 13, 14-15
Friends of Earth, Inc. v. Laidlaw Env’t Servs. (TOC) Inc.,
528 U.S. 167–81 (2000) ......................................................................................................... 11
Grand Lodge of Fraternal Order of Police v. Ashcroft,
185 F.Supp. 2d 9 (D.D.C. 2001) ................................................................................................7
Haitian Refugee Center v. Gracey,
809 F.2d 794 (D.C. Cir. 1987) ................................................................................................ 18
Havens Realty Corp. v. Coleman,
455 U.S. 363 (1982) ............................................................................................................... 10
Herbert v. Nat’l Acad. of Scis.,
974 F.2d 192 (D.C. Cir. 1992) .................................................................................................. 7
Jerome Stevens Pharms. v. FDA,
402 F.3d 1249 (D.C. Cir. 2005) ................................................................................................ 7
Lexmark Int'l, Inc. v. Static Control Components, Inc.,
572 U.S. 118 (2014) ............................................................................................................... 17
Lujan v. Defenders of Wildlife,
504 U.S. 555 (1992) .............................................................................................. 7-9, 8, 11-12
Maiden Creek Assocs. v. U.S. Dep't of Transp.,
823 F.3d 184 (3d Cir. 2016) ................................................................................................... 17
Match-E-Be-Nash-She-Wish Band of Pottawatomi Indians v. Patchak,
567 U.S. 209 (2012) ............................................................................................................... 17
Nader v. Fed. Election Comm'n,
725 F.3d 226 (D.C. Cir. 2013) ................................................................................................ 13
Nat’l Assoc. of Home Builders v. EPA,
667 F.3d 6 (D.C. Cir. 2011) ...................................................................................... 8-9, 11, 16
PETA v. USDA (PETA II)
797 F.3d 1087 (D.C. Cir. 2015) ................................................................................................ 9
Public Citizen v. Dep't of Justice,
491 U.S. 440 ........................................................................................................................... 14
Case 1:22-cv-00006-CJN Document 21 Filed 09/20/22 Page 6 of 27
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Public Citizen v. FTC,
869 F.2d 1541 (1989) ............................................................................................................. 13
Sierra Club v. EPA,
292 F.3d 895–99 (D.C. Cir. 2002) .......................................................................................... 11
Summers v. Earth Island Inst.,
555 U.S. 488, (2009) ........................................................................................................ 11, 16
U.S. Ecology, Inc. v. Dep’t of Interior,
231 F.3d 20 (D.C. Cir. 2000) .................................................................................................... 7
United Food & Com. Workers Union Local 751 v. Brown Grp., Inc.,
517 U.S. 544 (1996) ............................................................................................................... 11
United Transp. Union v. Interstate Com. Comm’n,
891 F.2d 908 (D.C.Cir.1989) .................................................................................................. 16
Venetian Casino Resport, LLC v. EEOC,
409 F.3d 359 (D.C.Cir.2005) .............................................................................................. 7, 15
Warth v. Seldin,
422 U.S. 490 (1975) ................................................................................................................. 8
Zivotofsky ex rel. Ari Z. v. Secretary of State,
444 F.3d 614 (D.C. Cir. 2006) ................................................................................................ 13
Statutes
5 U.S.C. § 553 ................................................................................................................................ 5
5 U.S.C. § 701 ................................................................................................................................ 2
16 U.S.C. § 1539 .......................................................................................................................... 15
42 U.S.C. § 289d ............................................................................................................ 1, 3, 14, 15
Pub. L. No. 99-158 (1985) ...............................................................................................................2
Regulations
22 C.F.R. § 52.8 ........................................................................................................................... 15
Rules
Fed. R. Civ. P. 12(b)(1)............................................................................................................... 2, 7
Fed. R. Civ. P. 12(b)(6)......................................................................................................... 3, 7, 17
Other Authorities
67 Fed. Reg. 14956 ...................................................................................................................... 15
Case 1:22-cv-00006-CJN Document 21 Filed 09/20/22 Page 7 of 27
Plaintiff, the White Coat Waste Project, Inc. (“White Coat”), is a “bipartisan taxpayer
watchdog organization.” ECF No. 17 Amended Complaint (“Am Compl.”) ¶ 6. White Coat’s
“mission is to unite animal-lovers and liberty-lovers to find, expose, and defund wasteful and
cruel taxpayer-funded animal experimentation.” Id. In this action, White Coat challenges
policies and external guidance that Defendants issued or promulgated pursuant to Section 495 of
the Public Health Services Act (“Services Act”) (42 U.S.C. § 289d). Services Act Section 495
provides that the Secretary of Health and Human Services (the “Secretary”) must establish
guidelines for the proper care and use of animals used in biomedical and behavioral research that
is funded by the National Institutes of Health (“NIH”) or any other national research institution.
Id. § 289d(a). The grant applicant must submit “assurances” to NIH that it complies with the
guidelines for the care and use of laboratory animals and NIH must deem the assurance
satisfactory for the grant applicant to remain eligible for NIH funding. Id. at § 289d(c)-(d).
Specifically, White Coat challenges the NIH guidance that allows a foreign grant applicant to
obtain approval of an animal welfare assurance without organizing an entity called an
Institutional Animal Care and Use Committee (“Institutional Animal Committee”).
White Coat does not claim to have ever applied for a research grant from NIH, nor that it
conducts any medical research at all. Rather, White Coat asserts that NIH’s application of the
animal welfare assurance requirement of Services Act Section 495 to foreign institutions
“directly conflicts with, impairs, and frustrates its organizational mission and has required
[White Coat] to divert and redirect its limited resources to counteract and offset Defendants’
unlawful actions and omissions.” Am Compl. ¶ 7. White Coat further asserts that the NIH
guidance on animal welfare assurances for foreign grant applicants causes White Coat “a
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significant and irreparable informational injury” because it is not able to obtain unspecified
information about the use of laboratory animals by foreign grant applicants. Id.
White Coat brings this action under the Administrative Procedure Act (“APA”) (5 U.S.C.
§ 701 et seq.). and asks the Court to declare that Defendants exceeded their statutory authority
when they issued guidance pursuant to Services Act Section 495 that allows foreign institutions
to obtain an animal welfare assurance without organizing an Institutional Animal Committee.
White Coat claims that portions of four separate publications that describe or implement this
guidance to foreign grant applicants violate the APA. The NIH publications at issue in this case
are: (1) Section II of the Public Health Service Policy on the Humane Care and Use of
Laboratory Animals (“Humane Care Policy”); (2) Section 4.1.1.4 of the NIH Grants Policy
Statement; (3) a NIH website containing instructions for foreign institutions seeking an animal
welfare assurance that White Coat refers to as the “Foreign Grants Website.”1; and (4) a NIH
website containing instructions for foreign Public Health Service grant applicants on obtaining
an animal welfare assurance (“Foreign Animal Welfare Assurance Guidance”)2 Am. Compl. ¶¶
25, 30-31, 33, 43.
The Court should dismiss Plaintiff’s Complaint under 12(b)(1) because Plaintiff lacks
standing to bring any of its claims under the APA. First, Plaintiff cannot maintain this action
because it fails to allege facts sufficient to establish organizational or representational standing.
1
Foreign Grants – Animal Welfare, https://grants.nih.gov/grants/foreign/animal_welfare.
htm (last visited Sept. 20, 2022).
2
Foreign Assurance, https://olaw.nih.gov/resources/documents/foreign.htm (last visited
Sept. 20, 2022). The Amended Complaint refers to this website as “the Foreign Animal Welfare
Assurance Rules” however this is not the title of the website and nowhere on the website does
NIH refer to any of its guidance this way.
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Second, Plaintiff fails to allege an informational injury sufficient to establish standing because
Plaintiff has not identified what information Defendants have failed to provide, why White Coat
is legally entitled to receive such information, or how this causes White Coat at concrete and
particularized injury. Should the Court reach Plaintiff’s alternative claims for relief, such claims
should be dismissed because White Coat lacks standing to assert a procedural claim under the
APA without a concrete injury in fact that could be redressed by the relief it seeks.3
Alternatively, the Court should dismiss the Amended Complaint under 12(b)(6). The Amended
Complaint fails to state a claim under the APA because the claims Plaintiff attempts to assert in
this action fall outside the Services Act’s zone of interests.
BACKGROUND
A.
THE ANIMAL WELFARE ASSURANCE REQUIREMENT OF THE PUBLIC
HEALTH SERVICE ACT
The Services Act was amended in 1985 by the Health Research and Extension Act, which
required the Secretary to establish guidelines for the humane care and use of animals used in
NIH funded biomedical and behavioral research. Pub. L. No. 99-158, § 495(a) (codified as
42 U.S.C. § 289d(a)). As amended, the Services Act requires that institutions receive NIH
approval of its assurances that it complies with these animal care guidelines when NIH funding
would support research involve the use of laboratory animals. Id. at §495(c), 99 Stat. at 876.
Pursuant to 42 U.S.C. § 289d(a), the Secretary of Health and Human Services promulgated the
Humane Care Policy. The Humane Care Policy instructs that institutions whose animal care
3
Local Civil Rule 7(n) requires that, in APA cases, the agency must file a certified copy of
the administrative record when the agency files a dispositive motion. See LCvR 7(n). However,
given that Defendant’s current dispositive motion focuses entirely on purely legal issues—
namely, Plaintiff’s lack of standing to sue, an administrative record is unnecessary for the Court
to rule on this threshold issue. Accordingly, concurrently herein, Defendants separately move to
be excused from Local Rule 7(n)’s requirements or, alternatively, to stay the submission of the
certified list of the administrative record until the Court resolves this dispositive motion.
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committee is an “Institutional Animal Care and Use Committee” seek approval of an animal
welfare assurance through an “institutional official” and sets forth the role of the Institutional
Animal Committee in acting as an agent for the institution that monitors the institution’s use of
animals in research funded by the Public Health Service. See Humane Care Policy Sec. IV.A-B.
The Humane Care Policy provides that the Institutional Animal Committee will prepare certain
reports for the Institutional Official and that some reports are submitted by the Institutional
Official to NIH and other are made available to NIH upon request. Id. at Sec. IV.B, F. NIH is
responsible for approving animal welfare assurances. See Id., Preface.
NIH guidance is clear that both domestic and foreign institutions that propose to use
animals in Public Health Service funded research must have their animal welfare assurance
approved by NIH to receive funding for research involving animals. See generally Humane Care
Policy at Sec. IV.A. (“No activity involving animals may be conducted or supported by the
[Public Health Service] until the institution conducting the activity has provided a written
Assurance acceptable to the [Public Health Service], setting forth compliance with the Policy”).
Per Section II of the Humane Care Policy, institutions in the United States, Puerto Rico, and U.S.
territories are required to follow the procedures described in the Humane Care Policy to obtain
NIH approval of an animal welfare assurance. Practically, this means that such institutions are
required to obtain such approval after a review by their Institutional Animal Committees which,
pursuant to the Humane Care Policy, must review the institution’s use and care of laboratory
animals that are to be used in Public Health Service funded research.
NIH has established an alternate application process for foreign institutions to receive
approval of their animal welfare assurance. See NIH Foreign Assurance, https://olaw.nih.gov/
resources/documents/foreign.htm (last visited Sept. 20, 2022). A foreign institution may obtain
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approval of its animal welfare assurance either through the Institutional Animal Committee
procedures in the Humane Care Policy or by submitting evidence to NIH that its proposed use of
animals in NIH funded research would be sufficiently humane. See Humane Care Policy, Section
II. The foreign institution seeking approval of an animal welfare assurance without an
Institutional Animal Committee (a “foreign assurance”) must also commit to following the
International Guiding Principles for Biomedical Research Involving Animals and any laws on
the welfare of laboratory animals that apply in the institution’s local jurisdiction. See Foreign
Grants Website.
B.
THE INSTANT LAWSUIT
On August 5, 2022, Plaintiff filed its Amended Complaint in the instant lawsuit against
the Department of Health and Human Services and NIH, alleging that specific provisions of the
Humane Care Policy, the Grants Policy Statement and other NIH guidance for foreign
institutions applying for grants violates the APA. See generally Am. Compl. The amended
complaint alleges that “NIH enacted multiple and binding agency rules” exempting foreign grant
recipients of NIH funding from using an animal care committee to monitor the institution’s
compliance with standards for the welfare of any laboratory animals used in NIH funded
research. Am. Compl. ¶ 1. Alternatively, Plaintiff alleges that the above-referenced provisions of
the Grants Policy Statement, the Humane Care Policy and the guidance for foreign grant
applicants constituted rule making within the meaning of the APA and were therefore subject to
the notice and comment requirements of 5 U.S.C. § 553. Am. Compl. ¶ 3.
Plaintiff seeks the following relief: (1) “declaratory judgment that Defendants have
violated the APA by exceeding their statutory authority through agency actions . . . including, at
a minimum, the [Institutional Animal Committee] exemption of NIH Grants Policy Statement
Sec. 4.1.1.4, the [Institutional Animal Committee] [e]xemption of the [Humane Care Policy], the
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[Institutional Animal Committee] exemption on the NIH Foreign Grants website, the
[Institutional Animal Committee] exemption of the Foreign Animal Welfare Assurance Rules,
and any equivalent agency rules, requirements, and publications;” (2) “an order vacating and
setting aside agency actions violating 42 U.S.C.A. §§ 289d(b)(1), (c)(1)(A) including, at a
minimum, the [Institutional Animal Committee] exemption of NIH Grants Policy Statement Sec.
4.1.1.4, the [Institutional Animal Committee] [e]xemption of the [Humane Care Policy], the
[Institutional Animal Committee] exemption on the NIH Foreign Grants website, the
[Institutional Animal Committee] exemption of the Foreign Animal Welfare Assurance Rules,
and any equivalent agency rules, requirements, and publications and enjoining Defendants from
using the Foreign Animal Lab Loophole, or any substantive equivalent”; (3) “an order vacating
and setting aside any awards of taxpayer funding and/or animal welfare assurances granted in
violation of 42 U.S.C.A. §§ 289d(b)(1), (c)(1)(A).” Am. Compl. at 31-32, ¶¶ A, B, C.
Alternatively, Plaintiff seeks (4) “a declaratory judgment that Defendants have violated
the APA by failing to notify the public and afford it an opportunity to comment on, at a
minimum, the [Institutional Animal Committee] exemption of NIH Grants Policy Statement Sec.
4.1.1.4, the [Institutional Animal Committee] [e]xemption of the [Humae Care Policy], the
[Institutional Animal Committee] exemption on the NIH Foreign Grants website, the
[Institutional Animal Committee] exemption of the Foreign Animal Welfare Assurance Rules,
and any equivalent agency rules, requirements, and publications;” and (5) “an order vacating and
setting aside, at a minimum the [Institutional Animal Committee] exemption of NIH Grants
Policy Statement Sec. 4.1.1.4, the [Institutional Animal Committee] [e]xemption of the [Humane
Care Policy], the [Institutional Animal Committee] exemption on the NIH Foreign Grants
website, the [Institutional Animal Committee] exemption of the Foreign Animal Welfare
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Assurance Rules, and any equivalent agency rules, requirements, and publications unless and
until the provisions have been properly adopted through notice-and-comment rulemaking.”
Finally, Plaintiff asks the Court to “award [Plaintiff] its costs and expenses, including reasonable
attorneys’ fees pursuant to applicable statutes and/or rules” and to “grant further and additional
relief as this Court may deem just and proper.” Am. Compl. at 32, ¶¶ D, E, F, G.
The Government now moves to dismiss under Rules 12(b)(1) and (6).
STANDARD OF REVIEW
To survive a motion to dismiss under Rule 12(b)(1), a plaintiff bears the burden of
proving that the Court has subject-matter jurisdiction to hear its claims. See Lujan v. Defenders
of Wildlife, 504 U.S. 555, 561 (1992); U.S. Ecology, Inc. v. Dep’t of Interior, 231 F.3d 20, 24
(D.C. Cir. 2000). A court has an “affirmative obligation to ensure that it is acting within the
scope of its jurisdictional authority.” Grand Lodge of Fraternal Order of Police v. Ashcroft,
185 F. Supp. 2d 9, 13 (D.D.C. 2001). For this reason, “‘the [p]laintiff’s factual allegations in the
complaint . . . will bear closer scrutiny in resolving a 12(b)(1) motion’ than in resolving a
12(b)(6) motion for failure to state a claim.” Id. at 13-14 (quoting 5A Charles A. Wright &
Arthur R. Miller, Federal Practice and Procedure § 1350 (2d ed. 1987) (alteration in original)).
Additionally, unlike when considering a motion to dismiss under Rule 12(b)(6), the Court “may
consider materials outside the pleadings in deciding whether to grant a motion to dismiss for lack
of jurisdiction.” Jerome Stevens Pharms. v. FDA, 402 F.3d 1249, 1253 (D.C. Cir. 2005); see also
Venetian Casino Resort, LLC v. EEOC, 409 F.3d 359, 366 (D.C. Cir. 2005) (“[G]iven the present
posture of this case—a dismissal under Rule 12(b)(1) on ripeness grounds—the court may
consider materials outside the pleadings.”); Herbert v. Nat’l Acad. of Scis., 974 F.2d 192, 197
(D.C. Cir. 1992).
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The elements of Article III standing are “an indispensable part of the plaintiff’s case,”
and “each element must be supported in the same way as any other matter on which the plaintiff
bears the burden of proof.” Lujan, 504 U.S. at 561. At the pleading stage, a plaintiff’s factual
allegations must be more than merely conclusory legal statements to the effect that standing
exists or that the plaintiff was injured. As the Supreme Court has stated, “[i]t is the
responsibility of the complainant clearly to allege facts demonstrating that he is a proper party to
invoke judicial resolution of the dispute and the exercise of the court’s remedial powers.” Warth
v. Seldin, 422 U.S. 490, 518 (1975); see also Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555
(2007) (complaint’s statement of the grounds for relief requires “more than labels and
conclusions, and a formulaic recitation of the elements of a cause of action will not do”);
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (“the tenet that a court must accept as true all of the
allegations contained in a complaint is inapplicable to legal conclusions,” and a court need not
accept as true “‘naked assertion[s]’ devoid of ‘further factual enhancement’”) (quoting Twombly,
550 U.S. at 557).
ARGUMENT
I.
PLAINTIFF LACKS ARTICLE III STANDING
The Court should dismiss Plaintiff’s claim as White Coat lacks Article III standing. “To
state a case or controversy under Article III, a plaintiff must establish standing.” Ariz. Christian
Sch. Tuition Org. v. Winn, 563 U.S. 125, 133-34 (2011); see Dominguez v. UAL Corp., 666 F.3d
1359, 1361 (D.C. Cir. 2012) (standing is a necessary “predicate to any exercise of our
jurisdiction”). To establish standing generally, a plaintiff must demonstrate having suffered an
injury-in-fact, specifically an injury that is “concrete, particularized, and actual or imminent;
fairly traceable to the challenged action; and redressable by a favorable ruling.” Clapper v.
Amnesty Int’l, 568 U.S. 398, 409 (2013). See Lujan, 504 U.S. at 560-61.
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A plaintiff must meet three requirements to establish standing. First, the plaintiff must
have suffered an injury in fact, “an actual or imminent invasion of a legally protected, concrete
and particularized interest.” Ctr. for Law & Educ. v. Dep’t of Educ., 396 F.3d 1152, 1157 (D.C.
Cir. 2005) (citing Lujan, 504 U.S. at 560-61); Nat’l Assoc. of Home Builders v. EPA, 667 F.3d 6,
11 (D.C. Cir. 2011) (“The ‘irreducible constitutional minimum of standing contains three
elements’: (1) injury-in-fact, (2) causation, and (3) redressability.”). Second, “there must be a
causal connection between the alleged injury and the defendant’s conduct at issue.” Id. That is,
the injury must be “‘fairly traceable to the challenged action.’” Clapper v. Amnesty Int’l USA,
568 U.S. 398, 409 (2013) (citation omitted). Third, “it must be ‘likely,’ not ‘speculative,’ that
the court can redress the injury.” Ctr. for Law & Educ., 396 F.3d at 1157 (citing Lujan, 504 U.S.
at 560-61).
An organization seeking to establish standing may “sue either on their own behalf
(‘organizational standing’) or on behalf of their members (‘representational standing’).” Citizens
for Resp. & Ethics in Wash. (“CREW”) v. U.S. Off. of Special Counsel, 480 F. Supp. 3d 118,
126-27 (D.D.C. 2020). It is not entirely clear from Plaintiff’s Amended Complaint whether
White Coat seeks to establish representational standing in addition to organizational standing.
See generally Am. Compl. One thing is clear—Plaintiff fails to allege facts sufficient to
establish either.
A.
Plaintiff Fails to Establish Organizational Standing
For organizational standing, an organization must allege a “concrete and demonstrable
injury to [its] activities.” CREW, 480 F. Supp. 3d at 127. The organization cannot establish
standing by seeking to “vindicate their own value preferences through the judicial process.” Id.
The D.C. Circuit uses a two-part test to analyze this inquiry: the court asks first “whether the
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agency’s action or omission to act ‘injured the [organization’s] interest’”; then, if satisfied, it
inquires whether “the organization ‘used its resources to counteract the harm.’” PETA v. Dep’t
of Agric. (“PETA II”), 797 F.3d 1087, 1094 (D.C. Cir. 2015); (alteration in original)
(quoting Equal Rts. Ctr. v. Post Props., Inc., 633 F.3d 1136, 1140 (D.C. Cir. 2011); accord Food
& Water Watch, Inc. v. Vilsack, 808 F.3d 905, 919 (D.C. Cir. 2015) (employing same test); see
also Havens Realty Corp. v. Coleman, 455 U.S. 363, 379 (1982) (finding organizational injury
based on an “injury to the organization's activities” followed by “the consequent drain on the
organization's resources”). In reviewing the injury analysis, the government activity must
“perceptively impair [] the organization’s ability to provide services.” CREW, 480 F.Supp. 3d
at 127. It is not enough that the organization’s mission has been compromised. Id.
(citing Abigail All. for Better Access to Dev. Drugs v. Eschenbach, 469 F.3d 129, 133 (D.C. Cir.
2006)). And not all use of resources will meet the second part of the test. CREW, 480 F. Supp.
3d at 128. “[T]he devotion of resources to advocacy for the organization’s preferred policy—
whether that advocacy is directed at Congress, the courts, or an administrative agency—falls
short of the line.” Id. at 128 (citing, among others, Ctr. for Responsible Sci. v. Gottlieb, 346 F.
Supp. 3d 29, 37 (D.D.C. 2018)). These are considered “self-inflicted” injuries. Id. (citing Abigail
All., 469 F.3d at 133).
Here, Plaintiff fails both prongs of the test. Nothing alleged in the Amended Complaint
supports the conclusion that Defendants’ actions have perceptively impaired the White Coat’s
ability to provide any services. See generally Am. Compl. Rather, White Coat expressly alleges
that its mission is being compromised, see Am. Compl. ¶ 7 (“[White Coat] brings this action on
its own behalf, and on behalf of its members, because the challenged conduct conflicts with,
impairs, and frustrates its organizational mission”), which is insufficient under D.C. Circuit
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precedents. See Abigail All., 469 F.3d at 133. White Coat alleges that Defendants’ actions have
“required it to divert and redirect its limited resources” and that this “hinders the development of
other organizational projects that would better advance [White Coat’s] mission[.]” Am Compl.
¶ 7. White Coat fails to specify what resources that it has invested as a result of Defendants’
action and why it was required to invest such resources. Nor does White Coat articulate what
alternative projects it was compelled to forego and why such decisions were compelled by
Defendants’ actions. Plaintiff has thus failed to allege facts sufficient to meet either prong of the
D.C. Circuit’s test to establish organizational standing.
B.
Plaintiff Fails to Establish Representational Standing
Any attempt by Plaintiff to establish representational standing fares no better. “To have
representational standing, an organization must show that ‘(a) its members would otherwise have
standing to sue in their own right; (b) the interests it seeks to protect are germane to the
organization’s purpose; and (c) neither the claim asserted nor the relief requested requires the
participation of individual members in the lawsuit.” Friends of Animals v. Ashe, 174 F. Supp.
3d 20, 28 (D.D.C. 2016) (citing Home Builders, 667 F.3d at 11 (quoting Ass’n of Flight
Attendants v. Dep’t of Transp., 564 F.3d 462, 464 (D.C. Cir. 2009), and United Food & Com.
Workers Union v. Brown Grp., Inc., 517 U.S. 544, 553 (1996))). To obtain injunctive relief in
particular, as White Coat seeks to do, a plaintiff “must show under the first prong of the test that
at least one of its members ‘is under threat of suffering injury in fact that is concrete and
particularized; the threat must be actual and imminent, not conjectural or hypothetical’; it ‘must
be fairly traceable to the challenged action of the defendant’[]—and “it must be likely that a
favorable judicial decision will prevent or redress the injury.”’ Home Builders, 667 F.3d at 12
(citing Summers v. Earth Island Inst., 555 U.S. 488, 493, (2009) (quoting Friends of Earth, Inc.
Case 1:22-cv-00006-CJN Document 21 Filed 09/20/22 Page 18 of 27
12
v. Laidlaw Env’t Servs. (TOC), Inc., 528 U.S. 167, 180–81 (2000))). While the burden of
production to establish standing is more relaxed at the pleading stage than at summary judgment,
a plaintiff must nonetheless allege “‘general factual allegations of injury resulting from the
defendant's conduct.’” Sierra Club v. EPA, 292 F.3d 895, 898–99 (D.C. Cir. 2002)
(quoting Lujan, 504 U.S. at 561 (alteration in Sierra Club)).
Again, Plaintiff fails to allege facts sufficient to meet several of the test’s prongs. First,
Plaintiff fails to allege facts sufficient to demonstrate that its members would have standing to
sue in their own right. See generally Am. Compl. White Coat has not carried its burden because
it has neither sufficiently alleged nor persuasively demonstrated any threat of injury in fact to
any of its members that is fairly traceable to an action of Defendants. On the causation prong,
Plaintiff must demonstrate a connection between the alleged injury to the member and the
agency action at issue. Ctr. for Law & Educ., 396 F.3d at 1157 (citing Lujan, 504 U.S. at 560–
61). Here, White Coat takes issue with the process NIH uses to approve animal welfare
assurances for foreign institutions applying for research grants but never explains what injury
this causes to its individual members aside from the inability to obtain unspecified information
about foreign grant applicants. Second, Plaintiff fails to show that it seeks to protect interests
that are “germane to the organization’s purpose.” In the Amended Complaint, White Coat
asserts that the separate process for obtaining an animal welfare assurance as a foreign institution
disadvantages domestic research institutions. See Am. Compl. ¶ ¶ 56, 74, 92, 110, 123, 143, 165,
183 (alleging that the NIH guidance at issue “allows foreign entities to compete for taxpayer
funds at a discount, as compared to domestic entities”). But the White Coat does not claim to
represent domestic research institutions and so its claimed interest in the way that NIH issues
animal welfare assurances to domestic and foreign grant applicants is not germane to White
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Coat’s purpose. In sum, White Coat fails to meet multiple prongs of the test required to establish
representational standing, and its claim should therefore be dismissed.
C.
Plaintiff Fails to Establish Informational Standing
Plaintiff fails to plead informational standing because it does not identify what
information it is entitled to by law or how the deprivation of this information results in a
particularized injury in fact. Plaintiff alleges that NIH’s foreign assurance guidance “excuses
foreign grant recipients from maintaining records related to its animal care committee as well as
reporting requirements involving violations that White Coat would otherwise be able to obtain
through the Freedom of Information Act, had the recipient been a domestic entity.” Plaintiff
asserts that this alleged double standard caused it to suffer “a significant and irreparable
informational injury that is actual and/or imminent.” Am. Compl. ¶ ¶ 7, 194. These allegations
cannot sustain an informational injury.
To establish an informational injury, a plaintiff must allege that “(1) it has been deprived
of information that, on its interpretation, a statute requires the government or a third party to
disclose to it, and (2) it suffers, by being denied access to that information, the type of harm
Congress sought to prevent by requiring disclosure.” Friends of Animals v. Jewell, 828 F.3d 989,
992 (D.C. Cir. 2016) (“Friends of Animals II”). “It is not enough . . . to assert that disclosure is
required by law. Only if the statute grants a plaintiff a concrete interest in the information sought
will he be able to assert an injury in fact.” Nader v. Fed. Election Comm’n, 725 F.3d 226, 229
(D.C. Cir. 2013); compare Friends of Animals v. Jewell, 824 F.3d 1033, 1041 (D.C. Cir. 2016)
(“Friends of Animals I”) (finding informational injury under Section 10(c) of the Endangered
Species Act, which required that information received by the Secretary be made available to the
public) with Friends of Animals II, 828 F.3d at 992-94 (finding no informational injury under
Case 1:22-cv-00006-CJN Document 21 Filed 09/20/22 Page 20 of 27
14
Section 4 of the ESA). As in Friends of Animals II, Plaintiff cannot assert that a general interest
in legal compliance creates a right to particular information, and that the inability to access that
information confers Article III standing.
The Supreme Court and this Court have found that a party has standing when Congress
expressly creates an individual right to receive information and subsequent conduct infringes on
the informational right. Pub. Citizen v. FTC, 869 F.2d 1541, 1548 (1989); Zivotofsky v. Sec’y of
State, 444 F.3d 614, 617 (D.C. Cir. 2006). An invasion of an individual right to information is
sufficiently concrete because it is “capable of judicial resolution” and is sufficiently
particularized because it affects the plaintiffs in an individual way. Zivitofsky, 444 F.3d at 619.
Thus, courts recognize a cognizable injury sufficient for standing only when the statutory
provisions under which a plaintiff sues are intended by Congress to grant a right of
information. See Fed. Election Comm’n v. Akins, 524 U.S. 11, 20-21 (1998) (holding that a
plaintiff's “inability to obtain information” that the Federal Election Campaign Act required to be
made public created an injury in fact because the Act's purpose was to protect voters by ensuring
that they had relevant information that was required); see also Pub. Citizen v. Dep’t of Just.,
491 U.S. 440, 445-46, 449-50 (1989) (finding that denial of information subject to disclosure
under the Federal Advisory Committee Act established standing because the purpose of the Act
was to keep Congress and the public apprised of the existence, activities, and cost of advisory
committees).
Here, Plaintiff has not alleged a concrete and particularized deprivation of information to
which it is entitled by law. White Coat alleges that it has been unlawfully deprived of
unspecified “pertinent information” about the animal care practices of foreign institutions with
approved animal welfare assurances. Am. Compl. ¶¶ 57, 75, 93, 111, 124, 144, 164, 184.
Case 1:22-cv-00006-CJN Document 21 Filed 09/20/22 Page 21 of 27
15
Section 495 of the Services Act does not require that NIH make public any records it receives as
part of grant applicants’ requests for approval of animal welfare assurances. In fact, the
Services Act does not even require grantees to report violations of animal care standards to NIH.
Rather, the only provision of the Services Act that requires grantees’ animal care committees to
submit information about violations to NIH is 42 U.S.C. § 289d(b)(3)(c) and this allows
grantees’ animal care committees to file assurances that the grantee is complying with 42 U.S.C.
§ 289d(b)(1) in lieu of reporting each violation. Accordingly, while it is not clear what specific
information White Coat believes it is entitled to, the Services Act does not confer on the public a
right to receive any particular information about approved animal welfare assurances.
Indeed, this provision is distinguishable from the one that conferred an informational right
in Friends of Animals I, 824 F.3d 1033. In that case, the court determined that Section 10(c) of
the ESA created a right to information because Section 10(c), in pertinent part, provided:
“Information received by the Secretary as a part of any application shall be available to the
public as a matter of public record at every stage of the proceeding.” 16 U.S.C. § 1539(c). Here,
by contrast, the Services Act Section 495 does not confer any informational rights on the White
Coat and does not require that NIH make public any information that it obtains as part of the
process that NIH follows to approve animal welfare assurances. Even if White Coat could
explain its legal entitlement to the “pertinent information” it seeks, it fails to articulate its
particularized need for this information aside from a general interest in the use of animals in NIH
funded research. Accordingly, Plaintiff fails to plead informational standing.
D.
Plaintiff Lacks Procedural Standing to Bring its Alternative Claims for
Relief
Contrary to Plaintiff’s allegations, NIH has in fact offered the public the opportunity to
submit comments on the Humane Care Policy. See e.g., 67 Fed. Reg. 14,956. (Mar. 28, 2002). In
Case 1:22-cv-00006-CJN Document 21 Filed 09/20/22 Page 22 of 27
16
fact, the Humane Care Policy is among the policies listed in the Code of Federal Regulations as
applying to NIH grant applicants. 22 C.F.R. § 52.8. Even assuming NIH never provided an
opportunity for the public to submit comments on its application of the animal welfare assurance
requirement to foreign grant applicants, White Coat lacks standing to bring its procedural claims
under the APA. In Summers v. Earth Island Institute, 555 U.S. 488, 496 (2009), the Supreme
Court stated that “deprivation of a procedural right without some concrete interest that is affected
by the deprivation—a procedural right in vacuo—is insufficient to create Article III standing.”
Id. The requirement of an injury-in-fact is a “hard floor” for Article III standing. Id at 497.
Because White Coat has failed to establish that the NIH guidance on foreign animal
welfare assurances has caused or will imminently cause the organization or its members injury-
in-fact, it therefore fails to establish any procedural standing to challenge Defendants’
promulgation of this guidance. See Home Builders v. EPA, 667 F.3d at 15 (“Without an
imminent threat of injury traceable to the challenged action, that floor [i.e., the requirement of
injury in fact] stands as a ceiling.”); United Transp. Union v. Interstate Com. Comm’n, 891 F.2d
908, 918 (D.C.Cir.1989) (“[B]efore we find standing in procedural injury cases, we must ensure
that there is some connection between the alleged procedural injury and a substantive injury that
would otherwise confer Article III standing. Without such a nexus, the procedural injury doctrine
could swallow Article III standing requirements.”) As discussed above, Plaintiff fails to allege a
specific, concrete injury that is traceable to NIH’s guidance to foreign research institutions on
obtaining an animal welfare assurance. “A prospective plaintiff must demonstrate that the
defendant caused the particularized injury, and not just the alleged procedural violation.” Ctr. for
Law & Educ., 396 F.3d at 1159 (internal quotation marks omitted; emphasis in original).
Case 1:22-cv-00006-CJN Document 21 Filed 09/20/22 Page 23 of 27
17
II.
PLAINTIFF FAILS TO STATE A CLAIM UNDER THE ADMINISTRATIVE
PROCEDURE ACT
Plaintiff fails to state an APA claim in this case because Section 495 of the Services Act
does not protect Plaintiff’s interest in acquiring more information about foreign recipients of
NIH funding. In what used to be referred to as “prudential standing,” a plaintiff cannot bring suit
for violations of statutes that were never intended to promote the interests plaintiff's suit would
advance, based on the presumption “that a statutory cause of action extends only to plaintiffs
whose interests ‘fall within the zone of interests protected by the law invoked.”’ Lexmark Int’l,
Inc. v. Static Control Components, Inc., 572 U.S. 118, 129 (2014) (quoting Allen v. Wright,
468 U.S. 737, 751 (1984)). To challenge agency action under the APA, a plaintiff must assert an
interest that falls “arguably within the zone of interests protected or regulated by the statute.”
Match-E-Be-Nash-She-Wish Band of Pottawatomi Indians v. Patchak, 567 U.S. 209, 224 (2012)
(quoting Ass’n of Data Processing Serv. Orgs. Inc. v. Camp, 397 U.S. 150, 153 (1970)). A zone
of interests dismissal is made under Rule 12(b)(6). See Maiden Creek Assocs. v. Dep’t of
Transp., 823 F.3d 184, 189 n.1 (3d Cir. 2016) (“[W]e must analyze . . . dismissal under Rule
12(b)(6) because the issue is whether appellants alleged harm that falls within NEPA’s zone of
interests, a question of statutory standing.”).
Plaintiff’s stated interest in NIH’s guidance on animal welfare assurances for foreign
grantees does not fall within the zone of interests protected by Section 495 of the Services Act.
White Coat asserts that the foreign animal welfare assurance guidance prevents it from receiving
the type of information that it receives about domestic grantees through requests under the
Freedom of Information Act. “To come within the zone of interests of the statute under which
suit is brought, an organization must show more than a general corporate purpose to promote the
Case 1:22-cv-00006-CJN Document 21 Filed 09/20/22 Page 24 of 27
18
interests to which the statute is addressed. Animal Legal Def. Fund, Inc. v. Espy, 23 F.3d 496,
503 (D.C. Cir. 1994). Rather, it must show a congressional intent to benefit the organization or
some indication that the organization is “a peculiarly suitable challenger of administrative
neglect.” Id. (quoting Akins, 524 U.S. at 20). “Informational injury, without more, does not fall
within the zone of interests of the statute under which suit is brought.” Animal Legal Def. Fund,
23 F.3d at 502. The D.C. Circuit has observed that “[i]f any person or organization interested in
promoting knowledge, enjoyment, and protection of the rights created by a statute . . . has an
interest that falls within the zone protected or regulated by the statute . . . then the zone-of-
interests test is not a test because it excludes nothing.” Haitian Refugee Ctr. v. Gracey, 809 F.2d
794, 813 (D.C. Cir. 1987); see also Animal Legal Def. Fund, 23 F.3d at 502 (stating that “[a]
continuous line of circuit precedent hold that claims of informational injury can surmount the
zone of interests threshold only in very special statutory contexts”).
Services Act Section 495 provides for the establishment of laboratory animal care
guidelines for institutions that receive NIH funds. It requires HHS to establish such guidelines
and for the grant applicants to assure NIH of their compliance with those guidelines. Plaintiff
does not allege that it applies for or receives NIH funds or submits animal welfare assurances for
NIH approval. Rather, Plaintiff tersely asserts that the guidance at issue “reduces transparency”
about the use of animals in government-funded research. See Am. Compl. ¶¶ 93, 111, 124, 144,
164, 184. The inability to disseminate more comprehensive information about the institutional
oversight of the use of laboratory animals by NIH grantees is not an injury against which the
Services Act protects and therefore it falls outside the zone of interests of the statute.
Accordingly, Plaintiff fails to state an APA claim challenging NIH’s foreign animal welfare
Case 1:22-cv-00006-CJN Document 21 Filed 09/20/22 Page 25 of 27
19
assurance guidance based on its desire that NIH make more information about its grant recipients
accessible to Plaintiff through the Freedom of Information Act.
CONCLUSION
Defendants present numerous justifications for the dismissal of the Complaint. In sum,
dismissal is warranted under Rules 12(b)(1) and 12(b)(6) as Plaintiff lacks Article III standing
and fails to state a claim.
Dated: September 20, 2022
Washington, D.C
Respectfully submitted,
MATTHEW M. GRAVES
United States Attorney
BRIAN P. HUDAK
Chief, Civil Division
By:
/s/ Michael E. Yohannan
MICHAEL E. YOHANNAN
Pennsylvania Bar No. 307575
Special Assistant United States Attorney
U.S. Attorney’s Office, Civil Division
601 D Street, N.W.
Washington, D.C. 20530
Tel: (202) 815-8969
Michael.Yohannan@usdoj.gov
Counsel for Defendants
Case 1:22-cv-00006-CJN Document 21 Filed 09/20/22 Page 26 of 27
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
WHITE COAT WASTE PROJECT, INC.,
Plaintiff,
v.
Civil Action No. 22-0006 (CJN)
U.S. DEPARTMENT OF HEALTH AND
HUMAN SERVICES, et al.,
Defendants.
[PROPOSED] ORDER
Upon consideration of Defendants’ Motion to Dismiss, Plaintiffs’ opposition and any
replies thereto, it is hereby
ORDERED that Defendants’ motion is GRANTED; and it is further
ORDERED that the Complaint is DISMISSED.
SO ORDERED.
Dated
United States District Judge
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