Court filing
Omnibus reply in support of motion to dismiss — White Coat Waste v. HHS (D.D.C.)
Filed December 16, 2022 in White Coat Waste v. HHS; one of 3 filings from this case.
Record facts
| Court | U.S. District Court for the District of Columbia |
|---|---|
| Filed | 2022-12-16 |
U.S. District Court for the District of Columbia · No. 1:22-cv-00006-CJN · Doc. 27 · 2022-12-16 · Docket on CourtListener
Full text
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
WHITE COAT WASTE PROJECT, INC.,
Plaintiff,
v.
U.S. DEPARTMENT OF HEALTH AND
HUMAN SERVICES, et al.,
Defendants.
Civil Action No. 22-0006 (CJN)
OMNIBUS REPLY IN SUPPORT OF DEFENDANTS’ MOTION TO DISMISS
AND MOTION FOR RELIEF FROM LOCAL RULE 7(n)
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
December 16, 2022
Case 1:22-cv-00006-CJN Document 27 Filed 12/16/22 Page 1 of 24
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TABLE OF CONTENTS
ARGUMENT .................................................................................................................................. 4
I.
WHITE COAT FAILS TO SHOW EITHER INFORMATIONAL OR
ORGANIZATIONAL STANDING ............................................................................................... 4
A. White Coat Has Not Established Informational Standing Because It Identifies No
Statutory Entitlement to Any Information It Claims Defendants are
Withholding……………………………………………………………………………4
B. White Coat Does Not Have Organizational Standing ...................................................... 7
i. White Coat Fails to Show Injury to its Organizational Interests ............................... 8
ii. White Coat’s Diversion of Resources to Advocacy Does Not Confer Standing ....... 12
II.
WHITE COAT LACKS PROCEDURAL STANDING TO BRING ITS ALTERNATIVE
CLAIMS FOR RELIEF ................................................................................................................ 14
III. WHITE COAT DOES NOT SATISFY THE HEIGHTENED ZONE OF INTERESTS
TEST FOR INFORMATIONAL INJURIES................................................................................ 15
IV. PRODUCTION OF THE CERTIFIED LIST OF THE CONTENTS OF THE
ADMINISTRATIVE RECORD IS PREMATURE ..................................................................... 18
Case 1:22-cv-00006-CJN Document 27 Filed 12/16/22 Page 2 of 24
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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) ............................................................................................ 7, 13
Am. Anti-Vivisection Soc’y v. USDA,
946 F.3d 615 (D.C. Cir. 2020) .................................................................................................. 9
Animal Legal Def. Fund, Inc. v. Espy,
23 F.3d 496 (D.C. Cir. 1994) .............................................................................................. 3, 16
Animal Legal Def. Fund v. Vilsack,,
No. 1:21-cv-1539, 2022 WL 16921506 (D.D.C. Nov. 14, 2022) ............................................. 9
Architects & Engineers for 9/11 Truth v. Raimondo,
No. 1:21-cv-2365, 2022 WL 3042181 (D.D.C. Aug. 2, 2022) ............................................. 5, 8
Assoc. of Data Processing Serv. Orgs. v. Camp,
397 U.S. 150 (1970) ............................................................................................................... 14
Bennett v. Spear,
520 U.S. 154 (1997) ............................................................................................................... 15
Citizens for Responsibility and Ethics in Washington (CREW) v. U.S. Off. of Special Counsel,
480 F.Supp. 3d 118 (D.D.C. 2020) ..................................................................................... 7, 13
Ctr. for Biological Diversity v. Trump,
453 F.Supp.3d 11 (D.D.C. 2020) ...................................................................................... 15, 16
Ctr. for Democracy & Tech. v. Trump,
No. 1:20-cv-01456, 2020 WL 7318008 (D.D.C. Dec. 11, 2020) ........................................... 12
Ctr. for Responsible Sci. v. Gottlieb,
346 F. Supp. 3d 29 (D.D.C. 2018) .......................................................................................... 13
Elec. Priv. Info. Ctr, v. Presidential Advisory Comm’n on Election Integrity,
266 F.Supp.3d 297 (D.D.C. 2017) ............................................................................................ 5
Environmental Integrity Project v. McCarthy,
139 F. Supp.3d 25 (D.D.C. 2015) ............................................................................................. 5
Equal Rts. Ctr. v. Post Props., Inc.
633 F.3d 1136 (D.C. Cir. 2011) ................................................................................................ 7
Food & Water Watch, Inc. v. Vilsack,
808 F.3d 905 (D.C. Cir. 2015) ............................................................................................ 7, 13
Case 1:22-cv-00006-CJN Document 27 Filed 12/16/22 Page 3 of 24
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Freedom Republicans, Inc. v. Fed. Election Comm’n,
13 F.3d 412 (D.C. Cir. 1994) .................................................................................................. 14
Friends of Animals v. Jewell,
828 F.3d 989 (D.C. Cir. 2016) .................................................................................................. 4
Havens Realty Corp. v. Coleman,
455 U.S. 363 (1982) ................................................................................................................. 7
Hazardous Waste Treatment Council v. Thomas,
885 F.2d 918 (D.C. Cir. 1989) ................................................................................................ 15
Jud. Watch, Inc. v. Office of Directory of Nat’l Intel.,
No. 1:17-cv-00508, 2018 WL 1440186 (D.D.C. Mar. 22, 2018) ............................................. 5
Kissinger v. Reporters Comm. For Freedom of the Press,
445 U.S. 136 (1980) ................................................................................................................. 5
Lexmark Int’l, Inc. v. Static Control Components, Inc.,
572 U.S. 118 (2014) ............................................................................................................... 15
Match-E-Be-Nash-She-Wish Band of Pottawatomi Indians v. Patchak,
567 U.S. 209, 224 (2012) ...........................................................................................................3
People for the Ethical Treatment of Animals v. U.S. Department of Agriculture
797 F.3d 1087 (D.C. Cir. 2015) ........................................................................ 9, 10, 11, 13, 14
Pub. Citizen Rsch. Grp. v. Pizzella,
513 F. Supp.3d 10 (D.D.C. 2021) ............................................................................................. 5
SafeCard Servs., Inc. v. SEC,
926 F.2d 1197 (D.C. Cir. 1991) ................................................................................................ 5
Schoenman v. F.B.I.,
573 F.Supp.2d 119 (D.D.C. 2008) ............................................................................................ 5
Summers v. Earth Island Inst.,
555 U.S. 488 (2009) ............................................................................................................... 14
Twin Rivers Paper Co., LLC v. SEC,
934 F.3d 607 (D.C. Cir. 2019) ................................................................................................ 15
Statutes
42 U.S.C. § 289d ............................................................................................................ 1, 2, 11, 17
Regulations
2 C.F.R. § 200.338 ......................................................................................................................... 6
45 C.F.R. § 5.1 ............................................................................................................................... 6
Case 1:22-cv-00006-CJN Document 27 Filed 12/16/22 Page 4 of 24
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Rules
Fed. R. Civ. P. 12 ................................................................................................................. 1, 2, 19
Other
D.D.C. LCvR 7 ......................................................................................................................... 3, 18
Case 1:22-cv-00006-CJN Document 27 Filed 12/16/22 Page 5 of 24
Defendants moved under Rule 12(b)(1) to dismiss in this matter because the Plaintiff, the
White Coat Waste Project, Inc. (“White Coat”), has not established standing. ECF No. 21
(“Defendants’ Motion”) (“Def. Mot.”). White Coat challenges Defendants’ implementation of
Section 495 of the Public Health Services Act (“Services Act”) (42 U.S.C. § 289d). Specifically,
White Coat challenges the guidance issued by Defendant the National Institutes of Health
(“NIH”) that allows a foreign grant applicant to obtain approval of an animal welfare assurance
(“foreign assurance”) under 42 U.S.C. § 289d(c) without organizing an entity in the research
institution called an Institutional Animal Care and Use Committee (“institutional animal
committee”).1 The allegations in White Coat’s Amended Complaint are plainly insufficient to
confer standing to challenge NIH’s foreign assurance guidance under the Administrative
Procedures Act (“APA”). White Coat cannot establish standing by alleging that the challenged
guidance prevents it from receiving information under the Freedom of Information Act
(“FOIA”). See Amended Complaint, ECF No. 17, (Am. Compl.) at ¶ 17. Nor can White Coat
establish organizational standing by alleging that the challenged NIH guidance “frustrates its
organizational mission[].” Id. Such allegations do not establish informational or organizational
standing in this Circuit.
Now, White Coat attempts to correct the deficiencies in its Amended Complaint by
offering the Court a detailed step-by-step description of how it conducts research for its
1
As Defendants stated in the opening brief, all recipients of NIH grants that propose to use
laboratory animals in NIH funded research are required to have an animal welfare assurance
approved pursuant to 42 U.S.C. § 289d(c). Def. Mot. at 11. NIH has established an alternative
process for foreign research institutions to obtain approval of an animal welfare assurance.
Institutions receiving a foreign animal welfare assurance (“foreign assurance”) must assure NIH
that they will comply with the International Guiding Principles for Biomedical Research Involving
Animals, which includes oversight and recordkeeping provisions, as well as any laws on the
welfare of laboratory animals that apply in the institution’s local jurisdiction. Id. at 12.
Case 1:22-cv-00006-CJN Document 27 Filed 12/16/22 Page 6 of 24
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advocacy activities related to the use (or alleged misuse) of laboratory animals in NIH funded
medical research. But these details do not cure its failure to establish standing to challenge
Defendants’ implementation of 42 U.S.C. § 289d with respect to foreign institutions that apply
for NIH grants that would fund research involving animals. First, White Coat is incorrect that
the FOIA entitles it to information about foreign NIH grant recipients that NIH does not and is
not required by statute to collect. As Defendants argued in their opening brief, White Coat has
not identified any provision of the Services Act that requires NIH to make available to the public
the records White Coat alleges are being unlawfully withheld. White Coat has still not identified
any such provision of the Services Act or any other federal statute. White Coat’s efforts to
revive its organizational standing theory fare no better. Rather, White Coat tries to frame its
more complex research activities as operational impediments that give rise to an organizational
injury. But White Coat’s failure to identify a specific change to its operations and how such a
change hindered its ability to provide any services other than advocacy defeats its claim to
organizational standing.2
Even if Plaintiff has standing, its injury falls outside the zone of interests protected by
Section 289d and therefore should be dismissed under Rule 12(b)(6). All claims brought under
the APA such as those brought by White Coat in this case must satisfy the zone-of-interests test.
2
Section IV(A) of White Coat’s opposition includes an argument on the merits of its
allegation that Defendants’ guidance to foreign research institutions on compliance with Section
289d is ultra vires. Pl. Op. at 10-25. This reply will not address those arguments because, at this
juncture, Defendants have moved dismiss under Rule 12(b)(1) for lack of standing and under Rule
12(b)(6) for alleging an injury that is not protected by Section 289d. Additionally, White Coat
inaccurately asserts that Defendants “admit[ed] that it has issued . . . a rule.” Pl. Op. at 51. It is
unclear what “rule” White Coat refers to here, but Defendants at no time conceded that any of the
challenged NIH guidance is a rule. After these threshold questions raised in the instant motion are
decided, Defendant reserves the right to contest the claims made in Section IV(A) of Plaintiff’s
Opposition.
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Match-E-Be-Nash-She-Wish Band of Pottawatomi Indians v. Patchak, 567 U.S. 209, 224 (2012).
The zone-of-interests test is all the more important where, as here, the Plaintiff brings suit based
on an alleged deprivation of information. Indeed, “a continuous line of circuit precedent holds
that claims of information injury can surmount the zone of interest threshold only in very special
statutory contexts.” Animal Legal Def. Fund, Inc. v. Espy, 23 F.3d 496, 502 (D.C. Cir. 1994).
No such special circumstance exists here. The Services Act does not require that any
information about NIH’s approval of assurances under Section 289d(c) be made public and does
contemplate a specific role for an organization like White Coat in the oversight of the use of
laboratory animals by foreign NIH grant recipients. White Coat’s theory of the zone-of-interests
test carries sweeping consequences, because any organization with a policy interest in a federal
agency’s activities could sue to require that agency to collect additional records for the purpose
of aiding the plaintiff organization in its advocacy activities. That understanding of the zone-of-
interests test would eviscerate the test entirely.
Finally, relief from Local Civil Rule 7(n) is appropriate here where the certified list of
contents of the administrative record would not help the Court decide the threshold legal
questions raised in Defendants’ motion to dismiss. Plaintiff’s argument that it is prejudiced in
responding to Defendants’ Motion without the certified list of the contents of the administrative
record is wholly without merit. Indeed, Plaintiff fails to explain how this certified list could cure
the deficiencies in its Amended Complaint.
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ARGUMENT
I.
WHITE COAT FAILS TO SHOW EITHER INFORMATIONAL OR
ORGANIZATIONAL STANDING
A.
White Coat Has Not Established Informational Standing Because It
Identifies No Statutory Entitlement to Any Allegedly Withheld Information
To establish standing based on an alleged deprivation of information, 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). Defendants’ Motion demonstrated that
White Coat’s Amended Complaint failed to identify what information it is entitled to receive by
statute. Def. Mot. at 20. White Coat still has not identified a statute that entitles it to the
information it seeks.
Instead, in its opposition to Defendants’ Motion, White Coat incorrectly argues that the
FOIA entitles it to records that NIH does not possess. Plaintiff’s Opposition to Defendants’
Motion, ECF No. 24, (“Pl. Op.”) at 39-40. Attempting to specify what records it believes it
should receive, White Coat refers to a provision of NIH’s Public Health Service Policy on
Human Care and Use of Laboratory Animals (“Humane Care Policy”) 3 that requires a grantee’s
institutional animal committee to report certain information to NIH. Pl. Op. at 39. Obviously,
the Humane Care Policy is not a statute and does not require that NIH make any information
available to the public anyhow. Therefore, it does not confer a statutory right to information that
might give rise to informational standing.
3
Public Health Service Policy on the Humane Care and Use of Laboratory Animals,
https://olaw.nih.gov/policies/phs-policy.htm (last visited Dec. 14, 2022).
Case 1:22-cv-00006-CJN Document 27 Filed 12/16/22 Page 9 of 24
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White Coat then advances the novel proposition that Defendants’ regulations
implementing the FOIA require that NIH collect information from foreign research institutions
that seek NIH approval of a foreign assurance. Id. The FOIA and Defendants’ regulations
implementing the FOIA may give a right of access to agency records, but these authorities
certainly do not create a statutory right of access to records that are not in Defendants’
possession and that Defendants are not required by statute to collect.
To satisfy the first element of the test for informational standing, a plaintiff must identify
“a statute”—not a regulation and not an agency policy—that “directly requires the defendant[s]
to disclose information that the plaintiff has a right to obtain.” Env’t Integrity Project v.
McCarthy, 139 F. Supp.3d 25, 36 (D.D.C. 2015). The FOIA does no such thing. Rather, the
FOIA may create an obligation to disclose an agency record only after such an agency record
exists. Schoenman v. F.B.I., 573 F.Supp.2d 119, 140 (D.D.C. 2008) (citing Kissinger v. Reps.
Comm. for Freedom of the Press, 445 U.S. 136, 152 (1980)). Informational standing, by
contrast, is found where “[d]efendants have already incurred an obligation to disclose
information.” Elec. Priv. Info. Ctr. v. Presidential Advisory Comm’n on Election Integrity,
266 F.Supp.3d 297, 311 (D.D.C. 2017). The FOIA also does not require the government to
collect documents. See SafeCard Servs., Inc. v. SEC, 926 F.2d 1197, 1201 (D.C. Cir. 1991)
(noting that the FOIA does not require agencies to “recreate or to reacquire a document that it no
longer has.”).
It is therefore unsurprising that White Coat points to not a single case in which a court
has ever accepted its theory of informational injury by a disappointing FOIA response. In fact,
courts in this district have rejected similar theories of informational injury on at least three
occasions. See Architects & Eng’rs for 9/11 Truth v. Raimondo, 1:21-cv-2365, 2022 WL
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3042181 at * 5 (D.D.C. Aug. 2, 2022) (holding that “FOIA…does not meet the first step for an
informational injury”); Pub. Citizen Rsch. Grp. v. Pizzella, 513 F. Supp.3d 10, 21 (D.D.C. 2021)
(stating that “to hold that FOIA is a statute that satisfies the first requirement for informational
injury would all but eviscerate the requirement.”); Jud. Watch, Inc. v. Off. of Director of Nat’l
Intel., Civ. A. No. 1:17-0508, 2018 WL 1440186, at *3 (D.D.C. Mar. 22, 2018) (stating that
“FOIA does not require the government to create documents but merely to produce documents
that it already maintains.”).
White Coat also references Defendants’ regulations implementing the FOIA, see Pl. Op.
at 41-42, but it is unclear how this helps their cause. By their own terms, those regulations apply
only to records that are subject to the FOIA. 45 C.F.R. § 5.1. It is nonsensical to suggest that
Defendants’ FOIA regulations create a right of access to records that Defendants do not have.
White Coat also attempts to cobble together an argument using 2 C.F.R. § 200.338 but gets
nowhere. Pl. Op. at 40-41. This regulation promulgated by the Office of Management and
Budget (“OMB”) provides that a federal agency may not place certain restrictions on a non-
federal entity that would limit public access to records pertinent to a Federal procurement award.
It is unclear what this regulation has to do with this case since White Coat is not alleging that it
suffered harms because Defendants are placing restrictions on non-Federal entities. Moreover,
the same regulation states that non-Federal entities are not required to permit public access to
their records unless required by statute.
By failing to satisfy the first element of the informational injury test, White Coat does not
and cannot address the second which requires that the plaintiff assert harms that Congress sought
to prevent by requiring the disclosure of the withheld records. Not only does the FOIA not
require NIH to collect any particular information, the Services Act does not require NIH to
Case 1:22-cv-00006-CJN Document 27 Filed 12/16/22 Page 11 of 24
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collect the information it alleges Defendants have withheld. White Coat points to a provision of
the Humane Care policy that instructs institutional animal care committees to submit certain
documentation to NIH. Pl. Op. at 39. But since Congress did not require that these records be
made public, White Coat’s inability to obtain any such records that NIH does not have could not
have been an injury that Congress sought to prevent. Accordingly, White Coat fails to plead
informational standing because it fails to identify a cognizable informational injury.
B.
White Coat Does Not Have Organizational Standing
For White Coat to show an injury for purposes of organizational standing, it must show
that NIH’s guidance and procedures for the approval of foreign animal welfare assurances
injured White Coat’s organizational interest, and that White Coat used its resources to counteract
that particular organizational harm. Food & Water Watch, Inc. v. Vilsack, 808 F.3d 905, 919
(D.C. Cir. 2015) (quoting Equal Rts. Ctr. v. Post Props., Inc. 633 F.3d 1136, 1138 (D.C. Cir.
2011)); 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”). A plaintiff pleading organizational standing
must allege both elements of the test. In reviewing the injury analysis, the government activity
must “perceptibly impair [] the organization’s ability to provide services.” Citizens for Resp. &
Ethics in Wash. (“CREW”) v. Off. of Special Counsel, 480 F.Supp. 3d 118, 127 (D.D.C. 2020).
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)).
Defendants’ opening brief pointed out that White Coat expressly alleged that its
purported injury was the frustration of its organizational mission. Def. Mot. at 17; 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
Case 1:22-cv-00006-CJN Document 27 Filed 12/16/22 Page 12 of 24
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mission”). White Coat now alleges that the challenged NIH guidance adversely impacts the
organization’s “daily operations.” Pl. Op. at 30. But White Coat does not allege that the foreign
assurance guidance has caused it to undertake any activities it was not already doing. White
Coat cannot manufacture organizational standing by reframing its deficient allegation of an
informational injury as an operational problem that impairs its ability to provide services.
Indeed, White Coat’s supposed operational problems are just descriptions of the complexities of
some of its research on foreign research institutions. To accept White Coat’s allegations as
stating an injury in fact would substantially expand the scope of organizational standing.
1.
White Coat Fails to Show Injury to its Organizational Interests
White Coat attempts bolster its theory that Defendants’ alleged frustration of its
organizational mission by recharacterizing frustration of its mission as an impact on its
operations. See Pl. Op. at 11 (“White Coat has organizational standing because its mission…and
its daily operations are directly impacted and perceptibly impaired” by the NIH foreign
assurance guidance). This allegation, however, is just White Coat’s attempt to shoehorn its
deficient informational injury into an organizational standing theory. Specifically, White Coat
alleges that the challenged NIH guidance causes an “information blackout” that “force[s]” White
Coat “to deviate from its normal operations and instead sort through an exponentially larger
volume of documents, none of which originate from [NIH].” Pl. Op. at 31-32. This theory
organizational injury depends on the existence of an informational harm which White Coat
cannot establish and, therefore, its organizational standing theory fails with it. See Architects &
Eng’rs, 2022 WL 3042181 at *3 (holding that the plaintiff failed to establish organizational
standing based on an informational injury). Moreover, White Coat’s description of the alleged
impact on its operations of NIH’s foreign assurance guidance is just a description of how White
Coat researches foreign NIH grantees and how that is more complex than research into domestic
Case 1:22-cv-00006-CJN Document 27 Filed 12/16/22 Page 13 of 24
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grantees. Pl. Op. at 32-33. But White Coat does not allege any specific new expenditures such as
additional staff it had to hire or services it had to procure as a result of the NIH foreign assurance
guidance.
An organization’s expenditure of its resources does not constitute an injury in fact unless
such an expenditure “subjects the organization to operational costs beyond those normally
expended.” Animal Legal Def. Fund v. Vilsack, Civ. A. No. 1:21-1539 (CJN), 2022 WL
16921506, at *6 (D.D.C. Nov. 14, 2022). In support of its theory that the complexity of some of
its research is a cognizable organizational injury, White Coat cites to cases in which, unlike
White Coat, the plaintiff organization actually changed or undertook new activities as a result of
the challenged government action. For example, in Am. Anti-Vivisection Society v. USDA, 946
F.3d 615 (D.C. Cir. 2020), the Court held that the plaintiff alleged an organizational injury by
alleging that it had to “fill the void” caused by USDA’s failure to enact a regulation as required
by statute. Id. at 619. The plaintiff in that case alleged that it had to issue guidance that would
have otherwise been provided by USDA. Id. But here, White Coat identifies no particular
change in its operations. White Coat’s research operations into foreign NIH grantees may
involve more steps than its research into domestic grantees, but White Coat does not allege that
these operations at some point changed as a result of Defendants’ actions. In short, White Coat
appears to be doing what it has always done.
White Coat also cites to People for the Ethical Treatment of Animals (“PETA”) v. USDA,
797 F.3d 1087 (D.C. Cir. 2015) but misstates the holding in that case. White Coat asserts that
the Court in PETA found that USDA’s failure to promulgate animal welfare regulations
pertaining to birds “frustrated [PETA’s] mission- forcing PETA to divert organizational
resources to conduct cruelty investigations of bird abuse and related educational efforts to offset
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the impact.” Pl. Op. at 27. That is incorrect. The Court in PETA did not find that plaintiff’s
organizational injury was the frustration of its mission. Rather, the Court found organizational
standing because plaintiff alleged that USDA’s failure to promulgate the regulations at issue
precluded plaintiff “from preventing cruelty and inhumane treatment of [birds] through its
normal process of submitting USDA complaints and it deprived [plaintiff] of key information
that it relies on to educate the public.” PETA, 797 F.3d at 1094. According to the plaintiff,
USDA’s action had the concrete effect of preventing it from using an established process for
redressing the mistreatment of animals due to USDA’s failure to promulgate the regulation at
issue. Id. at 1095. Here, White Coat identifies no formal process for it to request an investigation
into the use of laboratory animals by any NIH grant recipient and therefore cannot establish
organizational standing on the same theory accepted by the Court in PETA.
To be sure, the Court in PETA held that the plaintiff alleged an organizational injury
because of the plaintiff’s inability to file complaints with USDA about the mistreatment of birds,
which also caused the plaintiff to be deprived of information that would have resulted from those
investigations. Id. at 1094. But the Court did not find that plaintiff had informational standing on
the basis that it was deprived of information to which it was entitled by law. Rather, the
information at issue in PETA apparently consisted of inspection reports that USDA voluntarily
produced after investigative and enforcement efforts taken as a result of complaints involving
other animals. See id. at 1095 (noting that PETA alleged that the “resulting USDA inspection
reports are made available in an online database”). White Coat, by contrast, cannot show that it
would have automatically obtained additional information about foreign NIH grantees had
Defendants implemented the foreign assurances a different way because there is no statute that
gives White Coat access to that information and, as White Coat makes abundantly clear, the
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information it seeks is not made public as part of an agency process because White Coat requests
the information through the FOIA.
White Coat also claims that the foreign assurance guidance “obfuscates the identity and
number of foreign grantees conducting taxpayer-funded animal experimentation.” Pl. Op. at 30.
As an initial matter, it is not at all clear what White Coat believes is being “obfuscated” since
White Coat acknowledges that NIH makes public the identities of “foreign entities” with
assurances under the Services Act. Id. To the extent White Coat believes that additional
information would be helpful to its “daily operations[,]” it does not identify what that
information is or why it is entitled to such information. White Coat only claims that Section
298d requires that “certain documents” be filed with NIH “at least annually.” Pl. Op. 30. But
Section 289d only requires that animal care committees file an annual certification that they
conducted a compliance review and, if the committee observed violations, assurances that the
grantee has returned to compliance. See 42 U.S.C. § 289d(b)(3)(C). It does not require that any
of these records be made public. Crucially, White Coat does not claim that the alleged
withholding of this information hindered its ability to provide services. Indeed, White Coat’s
own detailed description of how it obtains the information it claims it was deprived of suggests
that White Coat is able to acquire such information by “querying public databases and
triangulating the findings with published research.” Pl. Op. at 31. The Court should not permit
White Coat solve its informational standing problem by extending the holding in PETA.4
Indeed, the PETA decision “marks the outer bounds of the Circuit’s highly permissive
4
Notably, White Coat does not argue that the alleged “informational blackout” and
“obfuscation” of the “identity and number of foreign grantees conducting tax-payer funded animal
experimentation” constitutes an informational injury.
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organizational standing doctrine.” Ctr. for Democracy & Tech. v. Trump, Civ. A. No. 20-1456,
2020 WL 7318008, at *5 (D.D.C. Dec. 11, 2020).
Rather than alleging that the NIH foreign assurance guidance hindered its ability to
provide services, White Coat alleges that the NIH foreign assurance guidance has “increase[ed]
[its] workload.” Pl. Op. at 11. But this is based on White Coat’s bald assertion that NIH’s
foreign assurance guidance “increases the prevalence of animal welfare violations” and that it
“increases the incidents of waste and abuse the [it] must discovery and investigate, while
simultaneously making it harder for White Coat to investigate them.” Id. at 35. White Coat
offers no basis for its assertion that NIH’s foreign animal guidance results in the mistreatment of
laboratory animals or waste and abuse of NIH grant funds. Moreover, White Coat does not
allege what particular steps it took to deal with an allegedly increased workload or how this
impacted its ability to provide any service. The closest it comes is in the Amended Complaint
wherein White Coat alleges that Defendants’ actions “hinder[] the development of other
organizational projects that would better advance [White Coat’s] mission[.].” Am Compl. ¶ 7.
But Defendants’ Motion pointed out that White Coat does not say what alternative projects were
hindered by Defendants’ actions. Def. Mot. at 18. White Coat still has not identified any
alternative activities it had to forego because of the challenged NIH guidance. White Coat’s
inability to articulate when its workload supposedly increased or how having more work
hindered its ability to deliver services further forecloses the availability or organizational
standing to bring this case.
2.
White Coat’s Diversion of Resources to Advocacy Does Not Confer
Standing
White Coat alleges that the foreign assurance guidance caused it to “divert resources
from enacting its mission and daily operations” when White Coat engaged in lobbying activities
Case 1:22-cv-00006-CJN Document 27 Filed 12/16/22 Page 17 of 24
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“to force NIH to comply with its duties under [Section] 289d.” Pl. Op. at 35-36. White Coat
further alleges that it “diverted resources to report to the media, the general public, and White
Coat’s…members and supporters about the [NIH foreign assurance guidance] to further pressure
NIH[]. Id.5 White Coat’s use of its resources to advocate for changes to the NIH foreign
assurance guidance is insufficient to show that it used its resources to counteract an injury to its
organizational interests. See 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.” CREW. at 128 (citing, among
others, Ctr. for Resp. 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). “[A]n
organization’s use of resources for litigation, investigation in anticipation of litigation, or
advocacy is not sufficient to give rise to an Article III injury.” Food & Water Watch, 808 F.3d
at 919 (quoting PETA, 797 F.3d at 1094).
In sum, Plaintiff fails both elements of the test for organizational standing. Neither the
Amended Complaint nor Plaintiff’s Opposition identifies a cognizable organizational injury to
White Coat. As for the second element, to the extent White Coat identifies any specific actions it
has taken to counteract alleged injuries, such actions consist only of lobbying and advocacy,
5
White Coat also alleges that it “has diverted at least $25,372.96 in organizational resources
in response” to the NIH foreign assurance guidance. Pl. Op. at 37. But a review of White Coat’s
explanation for how it arrived at this cost estimate reveals that it reflects the proportion of the
salaries of two of its staff members that corresponds to the amount of time those staff members
claim to have spent on researching institutions with foreign assurances. It does not reflect any
additional expenditures that White Coat has made. White Coat was not forced to “divert”
resources, rather it simply chose to have two employees conduct relatively more complicated
research.
Case 1:22-cv-00006-CJN Document 27 Filed 12/16/22 Page 18 of 24
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which are insufficient to establish organizational standing. Accordingly, White Coat had not
established organizational standing to bring this lawsuit.
II.
WHITE COAT LACKS PROCEDURAL STANDING TO BRING ITS
ALTERNATIVE CLAIMS FOR RELIEF
Defendants’ Motion argued that White Coat failed to establish procedural standing for its
alternative claims for relief because it had not alleged a cognizable informational or
organizational injury in fact. Def. Mot. at 23. 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.” Summers v. Earth Island Inst., 555
U.S. 488, 496 (2009). The requirement of an injury-in-fact is a “hard floor” for Article III
standing. Id at 497. White Coat’s only response to Defendants’ argument that it lacks procedural
standing to bring its alternative claims for relief is a two- sentence footnote in which White Coat
asserts that its proffered grounds for informational and organizational standing satisfy the test for
procedural standing. Pl. Op. at 51, n.11. “In order to make out [a] constitutionally cognizable
injury, plaintiffs must demonstrate that the allegedly deficient procedures implicate distinct
substantive interests as to which Article III standing requirements are independently satisfied.”
Freedom Republicans, Inc. v. Fed. Election Comm’n, 13 F.3d 412, 416 (D.C. Cir. 1994). Here,
White Coat has not adequately pled an informational or organizational injury so any possible
violation of notice-and-comment procedures, does not establish standing for White Coat’s
procedural claims under the APA.6
6
White Coat inaccurately claims that Defendants’ “assert[ed] [they] performed notice-and-
comment rulemaking regarding the [NIH foreign assurance guidance] contained in the [Humane
Care Policy]. Pl. Op. at 52. Defendants did no such thing. Rather, Defendants’ opening brief
pointed out that “NIH has in fact offered the public the opportunity to submit comments on the
Humane Care Policy” and cited one instance when this occurred. Def. Mot. at 22-23. Defendants’
Motion challenged White Coat’s procedural claim on issue of standing, not the merits. After the
Court addresses the threshold questions in Defendants’ Motion, Defendants reserve the right to
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III.
WHITE COAT DOES NOT SATISFY THE HEIGHTENED ZONE OF
INTERESTS TEST FOR INFORMATIONAL INJURIES
To satisfy the zone-of-interests test, a plaintiff must show that the interest it seeks to
protect is arguably within the zone of interests to be protected or regulated by the statute in
question. Assoc. of Data Processing Serv. Orgs. v. Camp, 397 U.S. 150, 153 (1970). The
Supreme Court has made clear that the zone-of-interests test “is a requirement of general
application” and “always applies and is never negated[.]” See Lexmark Int’l, Inc. v. Static
Control Components, Inc., 572 U.S. 118, 129 (2014) (quoting Bennett v. Spear, 520 U.S. 154,
163-64 (1997)). “Protected interests are ones asserted either by intended beneficiaries of the
statute at issue or by other suitable challengers—i.e., parties whose interests coincide
systemically, not fortuitously with those of intended beneficiaries.” Twin Rivers Paper Co., LLC
v. SEC, 934 F.3d 607, 616 (D.C. Cir. 2019) (quoting Hazardous Waste Treatment Council v.
Thomas, 885 F.2d 918, 921-22 (D.C. Cir. 1989).
White Coat first asserts that “a plaintiff need not satisfy the zone of interests analysis for
ultra vires claims” and cites to Ctr. for Biological Diversity v. Trump, 453 F. Supp. 3d 11, 48-49
(D.D.C. 2020) in support of that proposition. Pl. Op. at 43. But, unlike in this case, the ultra
vires claim in Ctr. for Biological Diversity was not brought under the APA.7 Ctr. for Biological
Diversity, at 24. Rather, in that case, the APA violations were alternative claims. Id. at 46.
contest White Coat’s procedural challenges including whether NIH’s foreign assurance guidance
requires notice-and-comment under the APA.
7
White Coat also asserts that “cases related to animal welfare proceeded without zone of
interests analysis” and cites PETA and Am. Anti-Vivisection as examples. Pl. Op. at 44, n.9. This
is misleading. Whether the claims in those cases satisfied the zone-of-interests test was not raised
and then considered by the Court. Indeed, White Coat itself cites to cases involving animal welfare
where the Court applied the zone-of-interests test. Pl. Op. at 36. White Coat is therefore incorrect
to the extent it argues that the zone-of-interests test need not apply to claims involving animal
welfare.
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Indeed, the Court in Ctr. for Biological Diversity applied the zone-of-interests test to the APA
claims in that case. Id. at 39. Here, White Coat brought its ultra vires claims under the APA (see
Am. Compl. at 11-18) and, therefore, it must still show that its interest in obtaining information
about foreign assurances approved by NIH falls within the zone of interests protected or
regulated by Section 289d.
White Coat urges the Court to use a “lenient standard” when applying the zone-of
interests-test to its claims. Pl. Op. at 45. But the D.C. Circuit has been clear that zone-of-
interests test is particularly narrow in the context of an alleged informational injury. See Animal
Legal Def. Fund v. Espy, 23 F.3d 496, 502 (D.C. Cir. 1994) (noting that “informational injury
can surmount the zone of interests threshold only in very special statutory contexts”). The
heightened standard for an informational injury to clear the zone-of-interests test is unsurprising
given that any plaintiff with an interest in an agency’s activities could sue the agency to change
its policies so that the plaintiff could obtain more information through vehicles such as FOIA.
Thus, to satisfy the zone-of-interests test, White Coat must demonstrate that Section 289d
protects its right to receive the specific information about institutions with NIH approved foreign
assurances.
White Coat does not explain how Section 289d of the Services Act protects its right to
obtain information about foreign assurances. Rather, White Coat incorrectly asserts that Section
289d “[]was crafted to generate public records[.]” Pl. Op. at 50. This is obviously incorrect
since Section 289d does not require that any information be made public. White Coat also
assumes that because it “routinely rel[ies] upon such records for investigation,” its alleged
informational injury “must be considered within [Section 289d’s] zone of interest.” Id. This self-
serving theory puts the statute in service of White Coat regardless of what the statute says.
Case 1:22-cv-00006-CJN Document 27 Filed 12/16/22 Page 21 of 24
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Section 289d requires NIH to collect very minimal information and does not require that any
such information be made public. Therefore, Section 289d does not even arguably protect White
Coat’s ability to receive information about foreign institutions with NIH approved foreign
assurances.
White Coat asserts that its “organizational injuries plainly fall within the zone of interests
of [Section] 289d[].” Pl. Op. at 49. It proffers two reasons for this, neither of which has
anything to do with whether White Coat’s purported organizational injuries (which, again, are
based entirely on an insufficient allegation of an informational injury) are protected by the
Services Act. First, White Coat claims that grant applicants seeking NIH approval of animal
welfare assurances are “conflicted by economic considerations” and therefore will not sue
Defendants over their implementation of Section 289d of the Services Act Pl. Op. at 47. But the
Services Act does not prescribe any particular role for an organization such as White Coat.8
Rather the Services Act provides that it is the responsibility of the Director of NIH to determine
that a grant applicant or recipient has submitted an adequate animal welfare assurance. 42 U.S.C.
§ 289d(c)(1). White Coat also claims that “NIH routinely relies on and acts upon the
investigations of animal welfare organizations.” Id. at 47. Even if this were true, it could not be
characterized as White Coat’s organizational injury.
It follows that White Coat is not a “suitable challenger” of Defendants’ compliance with
Section 289d of the Services Act because, though it characterizes its injury as an organizational
one, White Coat’s alleged injury is fundamentally about how NIH’s implementation of Section
8
Defendants acknowledge that the U.S. Government Accountability Office is presently
engaged in an audit of NIH’s oversight of the use of animals in foreign research that it funds. A
report on this audit is expected next year. This underscores that White Coat is incorrect that only
its deficient APA claims can prompt oversight of these activities. In fact, that oversight is
occurring.
Case 1:22-cv-00006-CJN Document 27 Filed 12/16/22 Page 22 of 24
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289d affects the scope of the public records it can acquire through the FOIA. But this is not an
interest that the Services Act protects and, therefore, White Coat is not a “peculiarly suitable
challenger” to the way in which Defendants implement Section 289d.
IV.
PRODUCTION OF THE CERTIFIED LIST OF THE CONTENTS OF THE
ADMINISTRATIVE RECORD IS PREMATURE
Simultaneous with the filing of its Motion to Dismiss, Defendants also moved for relief
from Local Civil Rule 7(n)(1) to file a certified list of the contents of the administrative record
(“certified index”). ECF No. 22. White Coat opposes that motion and claims that it is
prejudiced in responding to Defendants’ Motion to Dismiss without the certified index. See ECF
No. 25. White Coat claims that one reference to a Federal Register notice in Defendants’ Motion
to Dismiss “put the administrative record at issue” and “represent[ed] to the Court that the
Humane Care Policy underwent notice-and-comment. Id. at 3. That is simply not true.
At no time did Defendants “put the administrative record at issue” or represent that the
Humane Care Policy underwent notice-and-comment rulemaking. Moreover, White Coat does
not coherently or adequately explain why this reference to a Federal Register notice prejudiced
its ability to respond to Defendants’ legal arguments as to Article III standing and whether its
APA claims are within the zone of interests of the Services Act. Plaintiff’s claims of being
prejudiced in responding to Defendants’ Motion to Dismiss are based on mischaracterizations
and are all the more unconvincing given that Plaintiff in fact responded to Defendants’ standing
and zone of interests arguments without the certified index. Indeed, Plaintiff fails to articulate
with any specificity how the administrative record would establish standing, which is clearly
lacking here. In any event, the certified index of the administrative record would not help the
Court address the questions raised in Defendants’ Motion and is therefore unnecessary at this
juncture.
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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. Furthermore, the Court should grant Defendants’ motion for relief
from Local Civil Rule 7(n)(1).
Dated: December 16, 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
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