`
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`Plaintiffs,
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`
`
`- against -
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`----------------------------------------------------------
`X
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`:
`CENTER FOR FOOD SAFETY, BREAST
`:
`CANCER PREVENTION PARTNERS,
`:
`CENTER FOR SCIENCE IN THE PUBLIC
`:
`INTEREST, ENVIRONMENTAL DEFENSE
`:
`FUND, and ENVIRONMENTAL WORKING
`:
`GROUP,
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
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`:
`----------------------------------------------------------
`X
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`Appearances:
`
`Alexis Charlotte Andiman
`Carrie Apfel
`Peter Hans Lehner
`Eve C. Gartner
`Jonathan James Smith
`Earthjustice
`New York, New York
`Counsel for Plaintiffs
`
`George Kimbrell
`Center for Food Safety
`Portland, Oregon
`Counsel for Plaintiffs
`
`
`
`
`
`XAVIER BECERRA, SECRETARY,
`DEPARTMENT OF HEALTH AND HUMAN
`SERVICES; JANET WOODCOCK,
`COMMISSIONER, UNITED STATES FOOD
`AND DRUG ADMINISTRATION; and
`UNITED STATES FOOD AND DRUG
`ADMINISTRATION,
`
`
`Defendants.
`
`
`
`
`
`17-CV-3833 (VSB)
`
`OPINION & ORDER
`
`
`
`
`
`
`
`
`
`9/30/2021
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`
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`Case 1:17-cv-03833-VSB Document 100 Filed 09/30/21 Page 2 of 35
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`
`
`Michael James Byars
`Peter Max Aronoff
`U.S. Attorney’s Office, SDNY
`New York, New York
`Counsel for Defendants
`
`Devon Hill
`Eric P. Gotting
`Joseph Michael Dages
`Keller and Heckman LLP
`Washington, DC
`Counsel for Amicus Curiae Safe Food Ingredients Coalition
`
`
`VERNON S. BRODERICK, United States District Judge:
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`What do enzyme-treated pea protein, oat polar lipid extract, rice bran wax, and refined
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`shea butter have in common? These are substances that manufacturers have concluded to be
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`generally recognized as safe (“GRAS”) for their prescribed uses in food.1 Such substances—
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`substances generally recognized as safe—are at the heart of this case.
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`
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`Plaintiffs Center for Food Safety (“CFS”) and Environmental Defense Fund (“EDF”)
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`bring this action seeking declaratory and injunctive relief with respect to a final rule promulgated
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`by the United States Food and Drug Administration (“FDA”) entitled “Substances Generally
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`Recognized as Safe,” 81 Fed. Reg. 54,960 (Aug. 17, 2016) (the “GRAS Rule”). Plaintiffs move
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`for summary judgment on the grounds that the GRAS Rule (1) unlawfully subdelegates FDA’s
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`duty to ensure food safety in violation of the United States Constitution (the “Constitution”), the
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`Administrative Procedure Act (“APA”), and the Federal Food, Drug, and Cosmetic Act
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`(“FDCA”); (2) exceeds FDA’s statutory authority and constitutes arbitrary and capricious agency
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`action in violation of the FDCA and APA; and (3) conflicts with the FDCA. Defendants Xavier
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`
`1 See GRAS Notices, Nos. 892, 941, 948, 962, U.S. Food and Drug Admin.,
`https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=GRASNotices&sort=GRN_No&order=DESC&st
`artrow=1&type=basic&search= (last visited Sept. 30, 2021).
`
`2
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`
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`Case 1:17-cv-03833-VSB Document 100 Filed 09/30/21 Page 3 of 35
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`Becerra, Secretary of Health and Human Services; Janet Woodcock, Commissioner of Food and
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`Drugs; and FDA, (collectively, the “Government”), cross-move for summary judgment arguing
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`that the GRAS Rule is a lawful exercise of FDA’s authority under the FDCA, and is not
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`unconstitutional.2
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`
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`Because I find that FDA did not unlawfully subdelegate its authority, that the GRAS Rule
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`passes muster under the standards set forth in Chevron U.S.A., Inc. v. Natural Res. Def. Council,
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`Inc. (“Chevron”), 467 U.S. 837, 845 (1984), and Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State
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`Farm Mut. Auto. Ins. Co., (“State Farm”), 463 U.S. 29, 43 (1983), and that it does not conflict
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`with the FDCA, the Government’s motion for summary judgment is GRANTED. Plaintiffs’
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`motion is DENIED.
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`
`
`Background3
`
`A.
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`The Food Additives Amendment
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`The FDCA requires FDA to “protect the public health by ensuring that . . . foods are safe,
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`wholesome, sanitary, and properly labeled.” 21 U.S.C. § 393(b)(2). In 1958, Congress enacted
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`the Food Additives Amendment to the FDCA (the “Food Additives Amendment”), Pub. L. No.
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`85-929, 72 Stat. 1784 (1958), “in response to public concern about the increased use of
`
`
`2 Xavier Becerra, Secretary of Health and Human Services and Janet Woodcock, Commissioner of Food and Drugs
`are automatically substituted as parties pursuant to Fed. R. Civ. P. 25(d).
`3 The following factual summary is drawn from the allegations in the Complaint for Declaratory and Injunctive
`Relief (“Complaint” or “Compl.”), (Doc. 1), the special appendix, which contains the documents in the
`administrative record cited by the parties, (Docs. 97), and the administrative record (“Record”) provided to my
`chambers on a compact disk (“CD”). I will cite to the special appendix and Record interchangeably as “AR”. The
`parties previously agreed that Local Rule 56.1 statements of undisputed material fact were not necessary, and that
`the facts could be drawn from the Record. (Doc. 51.) My references to allegations within the Complaint should not
`be construed as a finding as to their veracity, and I make no such findings.
`Plaintiffs submitted five declarations with their motion for summary judgment, (see Docs. 67–71); however, these
`declarations are not referenced in their papers, and I do not rely on them here—therefore, I do not consider whether
`submission of these declarations was proper, (see Govt Mot. 9 n.2). The parties debate whether I should consider
`certain citations to evidence outside of the administrative record, (see Pls.’ Opp. 20); because these citations have no
`bearing on my resolution of the parties’ motions, I find it unnecessary to resolve this dispute.
`
`3
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`Case 1:17-cv-03833-VSB Document 100 Filed 09/30/21 Page 4 of 35
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`chemicals in foods and food processing,” 81 Fed. Reg. at 54,963. The purpose of the Food
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`Additives Amendment is “to prohibit the use in food of additives which have not been
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`adequately tested to establish their safety.” 72 Stat. 1784.
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`The Food Additives Amendment mandates that any “food additive” must go through an
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`approval process. See 21 U.S.C. § 348(b)–(g). Under this process, “the burden is on the
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`manufacturer to prove the safety of the use of the substance,” and “FDA must review and
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`approve the proposed use before the additive can be used in food.” (Compl. ¶ 36.) FDA
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`considers, among other things, “the probable consumption of the additive and of any substance
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`formed in or on food because of the use of the additive,” and “the cumulative effect of such
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`additive in the diet of man or animals, taking into account any chemically or pharmacologically
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`related substance or substances in such diet.” 21 U.S.C. § 348(c)(5).
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`The Food Additives Amendment provides a role for the public in the approval of food
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`additives. See generally 21 U.S.C. § 348. Specifically, it requires that FDA publish notice of a
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`proposed food additive regulation and the agency’s final decision on the underlying petition. Id.
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`§ 348(b), (c), (e). Any person adversely affected by FDA’s final decision may file objections
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`and request a public hearing, and the final decision is subject to judicial review. Id. § 348(f)–(g).
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`The Food Additives Amendment defines a “food additive” to include “substance the
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`intended use of which results or may reasonably be expected to result, directly or indirectly, in its
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`becoming a component or otherwise affecting the characteristics of any food.” 21 U.S.C. §
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`321(s). This definition exempts a category of substances that are:
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`generally recognized, among experts qualified by scientific training and experience
`to evaluate [their] safety, as having been adequately shown through scientific
`procedures (or, in the case of a substance used in food prior to January 1, 1958,
`through either scientific procedures or experience based on common use in food)
`to be safe under the conditions of [their] intended use.
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`4
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`Case 1:17-cv-03833-VSB Document 100 Filed 09/30/21 Page 5 of 35
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`Id. Based on the GRAS exemption to the Food Additives Amendment, described above,
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`substances such as vinegar, vegetable oil, baking powder, and many spices, flavors, gums, and
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`preservatives are lawfully marketed today. 81 Fed. Reg. at 54,963. After the passage of the
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`Food Additives Amendment, FDA “clarified the regulatory status of a multitude of food
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`substances that were used in food prior to 1958 and amended . . . regulations to include a list of
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`food substances that, when used for the purposes indicated and in accordance with good
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`manufacturing practice, are GRAS.” Id.; see 21 C.F.R. § 184.1005 et seq. (listing GRAS
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`substances). FDA, however, acknowledged that it would be impractical to list all GRAS
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`substances. 81 Fed. Reg. at 54,963; see 21 C.F.R. § 182.1(a). Procedurally, the Food Additives
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`Amendment does not require FDA to conduct a premarket review of whether the use of a
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`substance is GRAS. See 81 Fed. Reg. at 54,963.
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`B.
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`History of the GRAS Rule
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`Prior to the GRAS Rule, manufacturers could file a petition requesting a non-binding
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`“‘opinion letter,’ in which Agency officials would render an informal opinion on the GRAS
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`status of use of a substance.” 81 Fed. Reg. at 54,963. Subsequently, FDA instituted a voluntary
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`GRAS affirmation process under which manufacturers could ask FDA to affirm the GRAS status
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`of a particular use of a substance, thereby confirming that the substance was not a food additive
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`under the FDCA. 81 Fed. Reg. at 54,963–64. In so doing, manufacturers would provide FDA
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`with certain information, including “information to establish the safety and functionality of the
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`substance in food.” 21 C.F.R. § 170.35(c)(1) (reserved by 81 Fed. Reg. 54,960). Within thirty
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`days of the filing, FDA was required to publish a notice of filing in the Federal Register and
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`allow a sixty-day comment period. Id. § 170.35(c)(2), (c)(4). FDA could then either publish an
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`order that added the substance to the list of affirmed GRAS substances or publish a ruling that
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`5
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`Case 1:17-cv-03833-VSB Document 100 Filed 09/30/21 Page 6 of 35
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`the substance was not GRAS and therefore a food additive. Id. § 170.35(c)(5), (c)(6). This
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`GRAS affirmation process “involved the resource-intensive rulemaking process.” 81 Fed. Reg.
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`at 54,964.
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`
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`In April 1997, FDA proposed “to: (1) [c]larify the criteria for eligibility for classification
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`as GRAS;” “and (2) replace the GRAS affirmation petition process with a notification procedure
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`whereby any person may notify [the FDA] of a conclusion that a particular use of a substance is
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`GRAS.” Id. From 2008 to 2010, the Government Accountability Office (“GAO”) conducted a
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`study related to ingredients used in human food on the basis of the GRAS provision. Id. In
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`2010, GAO issued a report (“GAO Report”) that raised concerns about the proposed GRAS Rule
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`and proposed recommendations for FDA, including that FDA finalize the proposed GRAS Rule
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`and seek to minimize the potential for conflicts of interest in GRAS determinations. (See AR
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`008470–8543); U.S. Gov’t Accountability Off., GAO-10-246, FDA Should Strengthen Its
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`Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS) (2010).
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`In 2010, the comment period for the proposed rule was reopened to update comments and seek
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`additional comments on specific issues, including those raised by GAO. 81 Fed. Reg. at 54,964.
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`The proposed rule “invited interested persons to notify [FDA] about their conclusions of GRAS
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`status as described in the proposed rule.” Id.
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`FDA operated under the proposed GRAS Rule for nineteen years before publishing the
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`final GRAS Rule on August 17, 2016. (Compl. ¶¶ 51, 53); see 81 Fed. Reg. 54,960. The final
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`GRAS Rule codified FDA’s practice of allowing any person to notify FDA that a particular use
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`of a substance is GRAS. See id. at 54,966.
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`6
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`Case 1:17-cv-03833-VSB Document 100 Filed 09/30/21 Page 7 of 35
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`C.
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`The GRAS Rule
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`Under the GRAS Rule, “[a]ny person may notify FDA of a view that a substance is not
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`subject to the premarket approval requirements of section 409 of the Federal Food, Drug, and
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`Cosmetic Act based on that person’s conclusion that the substance is GRAS under the conditions
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`of its intended use.” 21 C.F.R. § 170.205. The GRAS Rule provides two ways for
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`demonstrating GRAS status. The first is through “scientific procedures,” which must be “the
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`same quantity and quality of scientific evidence as is required to obtain approval of a food
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`additive.” 21 C.F.R. § 170.30(b). GRAS conclusions under this provision “shall be based upon
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`the application of generally available and accepted scientific data, information, or methods,
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`which ordinarily are published, as well as the application of scientific principles, and may be
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`corroborated by the application of unpublished scientific data, information, or methods.” Id.
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`The second mechanism is for substances used in food prior to January 1, 1958, and requires that
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`a showing be made “through experience based on common use in food.” Id. § 170.30(a).
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`If a person chooses to submit a GRAS notice,4 the person providing such notice must
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`include the following information: (1) signed statements identifying the substance, its intended
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`conditions of use, the basis for the GRAS status, and a certification that the notice is a complete,
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`representative, and balanced submission, 21 C.F.R. § 170.225; (2) the identity, method of
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`manufacture, specifications, and physical or technical effects, id. § 170.230; (3) information
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`about dietary exposure, id. § 170.235; (4) information about any self-limiting levels of use,
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`including a level at which the substance would become unpalatable or technologically
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`impractical, id. § 170.240; (5) if applicable, information about experience based on common use
`
`
`4 GRAS notice refers to the submission to FDA that “informs [FDA] of [a person’s] view that a substance is not
`subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act based on [a person’s]
`conclusion that the substance is GRAS under the conditions of its intended use in accordance with § 170.30.” 21
`C.F.R. § 170.203. A GRAS notice has seven parts, id. § 170.220, which are described above.
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`7
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`Case 1:17-cv-03833-VSB Document 100 Filed 09/30/21 Page 8 of 35
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`in food before 1958, id. § 170.245; (6) a narrative of the basis for the GRAS conclusion, id. §
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`170.250; and (7) a list of supporting data and information in the notice, specifying which data are
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`generally available, id. § 170.255.
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`Within 180 days of a GRAS notice, with the opportunity for a 90-day extension, the FDA
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`will respond to the person who provided notice based on its “evaluation of [the] notice.” Id. §
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`170.265(b). FDA will respond in one of three ways: (1) a letter stating FDA does not question
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`the basis for the GRAS determination; (2) a letter stating that FDA concludes that the notice does
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`not provide a sufficient basis for a GRAS determination; or (3) a letter stating that at the
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`notifier’s request, FDA has ceased to evaluate the GRAS notice. About the GRAS Notification
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`Program, U.S. Food and Drug Admin., https://www.fda.gov/food/generally-recognized-safe-
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`gras/about-gras-notification-program (last visited Sept. 30, 2021). Before FDA’s response, a
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`person who submitted notice may request in writing that FDA cease to evaluate her GRAS
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`notice. 21 C.F.R. § 170.260(b). Under the GRAS Rule, FDA makes publicly available “[a] list
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`of filed GRAS notices, including [certain] information” included in the notice and “[t]he text of
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`any letter” FDA issues, including any letter issued when granting a request to cease evaluating a
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`notice. Id. § 170.275(b). Other information in a GRAS notice is subject to disclosure under the
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`Freedom of Information Act. Id. § 170.275(a).
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`The GRAS Rule’s notification process is voluntary. See 81 Fed. Reg. 54,960 (FDA noted
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`that it was “amending [its] regulations to replace the voluntary GRAS affirmation petition
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`process with a voluntary notification procedure under which any person may notify [FDA] of a
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`conclusion that a substance is GRAS under the conditions of its intended use.”). FDA, however,
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`retains authority to take various actions, including issuing warnings and stopping distribution,
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`when a substance does not qualify for GRAS status. Id. at 54,980–81.
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`8
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`Case 1:17-cv-03833-VSB Document 100 Filed 09/30/21 Page 9 of 35
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`
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`Procedural History
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`On May 22, 2017, Plaintiffs—a group of nonprofit advocacy organizations—filed this
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`action seeking a declaratory judgment that the GRAS Rule (1) violates fundamental principles of
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`separation of powers; (2) exceeds FDA’s statutory authority; (3) does not accord with the law;
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`(4) is arbitrary and capricious; and (5) is an abuse of discretion. (Compl. ¶¶ 14, 19–28.)
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`Plaintiffs also seek equitable relief vacating the GRAS Rule and directing FDA to reissue a rule
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`that is in accordance with the FDCA. (Id. ¶ 14.)
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`On September 22, 2017, the Government filed a motion to dismiss for lack of jurisdiction
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`pursuant to Federal Rule of Procedure 12(b)(1), (Doc. 30), which was fully briefed in November
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`2017, (see Docs. 31, 35, 36). On September 12, 2018, I issued an Opinion & Order denying the
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`Government’s motion as to Plaintiffs CFS and EDF because they had standing to pursue their
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`claims based on harm to their members, and granting the Government’s motion as to Plaintiffs
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`Breast Cancer Prevention Partners, Center for Science in the Public Interest, and Environmental
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`Working Group. (Doc. 44.)
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`After extending the Government’s time to answer, (Doc. 47), the Government answered
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`on October 4, 2018, (Doc. 50). I subsequently endorsed the parties’ proposed schedule for
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`production of the Record and summary judgment briefing. (Doc. 52.) Thereafter, I granted
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`Plaintiffs’ request for an extension of time to advise the Government that they were satisfied that
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`the Record was complete. (Doc. 59). In December 2018, this case was stayed due to a lapse in
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`funding to the United States Department of Justice. (Doc. 60.) The government shutdown ended
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`on January 25, 2019, and funding was restored. On February 19, 2019, the Government filed a
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`joint letter stating that “Plaintiffs [] advised the government that they will not file any motions to
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`complete or supplement the record”, and proposing that Plaintiffs’ summary judgment deadline
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`9
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`Case 1:17-cv-03833-VSB Document 100 Filed 09/30/21 Page 10 of 35
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`be set for March 26, 2019, which was 60 days after the government shutdown ended. (Doc. 63.)
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`I granted this request. (Doc. 64.)
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`On March 26, 2019, Plaintiffs filed a motion for summary judgment, a memorandum of
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`law in support of their motion, and five declarations in support. (Docs. 65–71.) Subsequently, I
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`extended the remaining briefing deadlines. (Doc. 73.) On June 17, 2019, the Government filed a
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`cross motion for summary judgment and a memorandum of law in support. (Docs. 74–75.) In
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`July of 2019, Safe Food Ingredients Coalition (“SFIC”) requested that I grant it leave to file a
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`brief as amicus curiae in support of the Government’s cross-motion. I granted the request and
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`directed SFIC to file it amicus brief by July 26, 2019, (Doc. 76), which it did, (Doc. 83.) On
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`August 23, 2019, Plaintiffs filed their opposition to the Governments’ cross-motion. (Doc. 85.)
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`After granting the Government’s extension request, (Doc. 87), and request to file excess pages,
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`(Doc. 89), the Government filed its reply, (Doc. 90). On October 2, 2020, Plaintiffs requested
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`oral argument, (Doc. 91), and I denied Plaintiffs’ request on October 7, 2020, (Doc. 92).
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`On July 23, 2021, I issued an order explaining that it was unclear based on the docket
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`whether the parties provided me with the Record. (Doc. 95.) I directed the parties to inform me
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`whether they did in fact provide me with the Record, and if so, to provide me with another copy
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`of the Record, by on or before July 30, 2021. (Id.) If the parties had not provided me with the
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`record, I directed them to file a certified index of the Record, and a joint appendix containing
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`only the cited portions of the Record, by on or before August 6, 2021. The parties filed a letter
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`indicating that after reviewing the case file, the Government could not conclusively determine
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`whether it previously provided a copy of the administrative record to chambers. (Doc. 96.) The
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`Government indicated it would file the index of the complete administrative record, including a
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`certification; and a special appendix including only those documents in the record that either
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`10
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`Case 1:17-cv-03833-VSB Document 100 Filed 09/30/21 Page 11 of 35
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`party cited in their briefing. (Id.) The parties also proposed to provide a copy of the full record
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`on compact disk (“CD”) to chambers and to send an additional copy of the same CD to the Clerk
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`of Court to maintain. (Doc. 96.) I endorsed the parties’ proposed plan for submitting the record.
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`(Doc. 98.) The Government filed the appendix containing cited excerpts of the record and a
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`certified index of the complete administrative record. (Docs. 97, 99.) The entire Record was
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`provided to me on a CD.
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` Legal Standard
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`Under Federal Rule of Civil Procedure 56, summary judgment is appropriate when “the
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`parties’ submissions show that there is no genuine issue as to any material fact and the moving
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`party is entitled to judgment as a matter of law.” Fay v. Oxford Health Plan, 287 F.3d 96, 103
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`(2d Cir. 2002); see also Fed. R. Civ. P. 56(a). “When a party seeks review of agency action
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`under the APA, the ‘entire case on review is a question of law’ such that ‘judicial review of
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`agency action is often accomplished by filing cross-motions for summary judgment.’” Just
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`Bagels Mfg., Inc. v. Mayorkas, 900 F. Supp. 2d 363, 372 (S.D.N.Y. 2012) (quoting Connecticut
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`v. U.S. Dep’t of Commerce, No. 3:04cv1271 (SRU), 2007 WL 2349894, at *1 (D. Conn. Aug.
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`15, 2007)). Accordingly, “the usual Rule 56 summary judgment standard does not apply in such
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`cases, because the court is resolving legal questions when it determines if the agency acted in
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`excess of statutory authorization, not in accordance with law, arbitrarily and capriciously, or in
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`some other way that violates 5 U.S.C. § 706.” New York v. U.S. Dep’t of Health & Human
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`Servs., 414 F. Supp. 3d 475, 516 (S.D.N.Y. 2019) (internal quotation marks omitted).
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`“Generally, a court reviewing an agency decision is confined to the administrative record
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`compiled by the agency when it made the decision.” Id. at 517 (internal quotation marks
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`omitted).
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`11
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`Case 1:17-cv-03833-VSB Document 100 Filed 09/30/21 Page 12 of 35
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` Discussion
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`Plaintiffs argue that the GRAS Rule (1) unlawfully subdelegates FDA’s duty to ensure
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`food safety in violation of the Constitution, the APA, and the FDCA; (2) exceeds FDA’s
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`statutory authority, and constitutes arbitrary and capricious agency action in violation of the
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`FDCA and APA; and (3) conflicts with the FDCA. The Government cross-moves for summary
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`judgment essentially arguing the opposite: that the GRAS Rule is a lawful exercise of FDA’s
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`authority under the FDCA and is not unconstitutional.
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`A. Subdelegation Challenge
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`1. Applicable Law
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`“An agency impermissibly delegates its authority where, without statutory
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`authorization, ‘it shifts to another party almost the entire determination of whether a specific
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`statutory requirement . . . has been satisfied, or where it abdicates its final reviewing authority.’”
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`Cooling Water Intake Structure Coal. v. U.S. Envtl Prot. Agency, 905 F.3d 49, 79 (2d Cir. 2018)
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`(quoting Fund for Animals v. Kempthorne, 538 F.3d 124, 133 (2d Cir. 2008)); see also United
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`States Sec. & Exch. Comm’n v. Alpine Sec. Corp., 982 F.3d 68, 81 (2d Cir. 2020). Although
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`“[a]gencies may seek advice and policy recommendations from outside parties, . . . they may not
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`‘“rubber-stamp” decisions made by others under the guise of seeking their “advice”.’” Fund for
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`Animals, 538 F.3d at 133 (quoting U.S. Telecom Ass’n v. FCC, 359 F.3d 554, 568 (D.C. Cir.
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`2004)).
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`As the D.C. Circuit has explained, there is a distinction between a subdelegation to a
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`subordinate federal officer or agency and subdelegation to an outside party. See U.S. Telecom
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`Ass’n, 359 F.3d at 565.
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`[W]hen an agency delegates power to outside parties, lines of accountability may
`blur, undermining an important democratic check on government decision-making.
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`12
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`Case 1:17-cv-03833-VSB Document 100 Filed 09/30/21 Page 13 of 35
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`Also, delegation to outside entities increases the risk that these parties will not share
`the agency’s national vision and perspective, and thus may pursue goals
`inconsistent with those of the agency and the underlying statutory scheme.
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` Id. at 565–66 (internal citations and quotation marks omitted). In other words, “subdelegation to
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`outside entities aggravates the risk of policy drift inherent in any principal-agent relationship.”
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`Id. at 566.
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`2. Application
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`Plaintiffs argues that “Congress delegated to FDA the responsibility of ensuring that our
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`nation’s food is safe and free from harmful substances” and that the GRAS Rule “unlawfully
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`subdelegates—or shifts—to manufacturers this core governmental duty, allowing them to decide
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`for themselves, in secret, whether the chemical substances they have synthesized may be added
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`to food.” (Pls.’ Mot. 8.)5 Plaintiffs broadly assert separation of powers concerns. (See id. at 8–
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`14.) The Government responds that contrary to Plaintiffs’ framing of the issue, subdelegation
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`claims are treated as statutory, not constitutional claims, and regardless, Plaintiffs’ claim fails
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`because the GRAS Rule does not subdelegate agency authority.6 (Govt. Mot. 18.)7
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`In Fund for Animals, the Second Circuit held that a depredation order which authorized
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`“State fish and wildlife agencies, Federally recognized Tribes, and State Directors of the Wildlife
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`Services program . . . to prevent depredations on the public resources of fish . . . , wildlife, plants,
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`and their habitats by taking without a permit double-crested cormorants found committing or
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`about to commit, such depredations” did not unlawfully subdelegate the responsibility of the Fish
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`5 “Pls.’ Mot.” refers to Plaintiffs’ memorandum of law in support of Plaintiffs’ motion for summary judgment, filed
`on March 26, 2019. (Doc. 66.)
`6 I note at the outset that I do not resolve whether Plaintiffs’ claim should be treated as constitutional or statutory
`because I find that the GRAS Rule is not an unlawful subdelegation of FDA’s authority.
`7 “Govt. Mot.” refers to the Government’s memorandum of law in support of their cross-motion for summary
`judgment and opposition to Plaintiffs’ motion for summary judgment, filed on June 17, 2019. (Doc. 75.)
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`and Wildlife Service (“FWS”) to regulate migratory birds under the Migratory Bird Treaty Act
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`(“MBTA”). 538 F.3d at 130, 133 (internal quotation marks omitted). The Second Circuit
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`explained that:
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`the authority delegated by Congress to the FWS under the MBTA bears little
`resemblance to the far narrower band of discretion afforded to those acting under
`the Depredation Order. The MBTA requires the Secretary “to determine when, to
`what extent, if at all, and by what means, it is compatible with the terms of the
`conventions” to permit takings and killings of migratory birds. By contrast, third
`parties acting pursuant to the Depredation Order are limited to takings of
`cormorants, and cormorants only, and even then, solely “to prevent depredations
`on the public resources of fish . . . , wildlife, plants, and their habitats.”
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`Id. at 133. Additionally, the Second Circuit observed that unlike the process for issuing
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`depredation permits, which requires that FWS affirmatively issue a permit or order before
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`any depredation control occurs, the Depredation Order allows the parties to provide such
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`information after the fact. Id.; see id. at 130 (Depredation Order requires a yearly notice
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`for those years in which the agency intends to act and annual reports describing their
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`activities under the Depredation Order). The Second Circuit noted, “[t]here is, however,
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`no statutory requirement that the FWS provide prior authorization in the form of a permit
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`for specific takings of migratory birds. The MBTA mandates only ‘suitable regulations
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`permitting and governing’ takings. The regulations restricting the taking of migratory
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`birds, even in the absence of an advance permitting scheme, satisfy this statutory
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`requirement.” Id. at 133 (internal citation omitted).
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`As the Government correctly points out, “the FDCA does not impose mandatory
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`GRAS notification on manufacturers or require FDA to review industry GRAS
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`conclusions in advance of marketing.” (Govt. Mot. 18.) Instead, FDA has the power to
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`take enforcement action if it does not agree with a person’s GRAS determination. See 81
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`Fed. Reg. at 54,980–81. Like the statute at issue in Fund for Animals, “there is . . . no
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`statutory requirement that the [FDA] provide prior authorization [that a substance is
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`GRAS].” 538 F.3d at 131. Although in Fund for Animals, the FWS did retain some
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`authority to regulate takings before they occurred, Plaintiffs are incorrect that the Second
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`Circuit “premised its approval on the existence of pre-violation oversight mechanisms,”
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`(Pls.’ Opp. 9)8; instead, the court explicitly held that “[t]he regulations restricting the
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`taking of migratory birds, even in the absence of an advance permitting scheme, satisfy
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`th[e] statutory requirement,” Fund for Animals, 538 F.3d at 133.9
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`Plaintiffs’ argument here is even less compelling than plaintiffs’ argument in
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`Fund for Animals. Congress delegated “to FDA the responsibility of ensuring that our
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`nation’s food is safe and free from harmful substances.” (Pls.’ Mot. 8 (citing 72 Stat.
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`1784; 21 U.S.C. § 393(b)).) If the FDA has delegated anything at all to manufacturers, it
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`is simply the ability to notify FDA of a GRAS determination, with which FDA can agree
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`or disagree. “[T]he authority delegated by Congress to the [FDA] . . . bears little
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`resemblance to the far narrower band of discretion afforded to those acting under the
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`[GRAS Rule].” Fund for Animals, 538 F.3d at 133. As the Government aptly notes, “[i]f
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`8 “Pls.’ Opp.” refers to Plaintiffs’ opposition to Defendants’ cross-motion for summary judgment and reply to
`Defendants’ opposition to Plaintiffs’ motion for summary judgment, filed on August 23, 2019. (Doc. 85.)
`9 Plaintiffs argue that FDA “invokes one of two independent Second Circuit tests set forth in Fund for Animals for
`determining whether a subdelegation is permissible,” and “completely ignores the Second Circuit’s second,
`independent test for determining whether an unlawful subdelegation has occurred. Under this test, an agency
`subdelegates authority when it abdicates ‘final reviewing authority,’ or pre-violation oversight.” (Pls.’ Opp. 7–8)
`(quoting Fund for Animals, 538 F.3d at 133).) While the test does include determining whether an agency abdicated
`its “final reviewing authority,” Fund for Animals makes clear that is not equivalent to “pre-violation oversight”;
`Plaintiffs’ citation to a sentence from a non-binding case that was cited in Fund for Animals is misleading, (see Pls.’
`Opp. 8–9), and is inconsistent with the holding in Fund for Animals that “[t]he regulations restricting the taking of
`migratory birds, even in the absence of an advance permitting scheme, satisfy th[e] statutory requirement,” Fund for
`Animals, 538 F.3d at 133.
`Cooling Water, 905 F.3d at 80, cited to by both parties, (see Pls.’ Mot. 10–11; Govt. Mot. 18), held that an unlawful
`delegation did not occur where the agency retained oversight and the rule reflected a “cooperative arrangement
`specified by Congress in the [statute] and by the agencies in their [memorandum of agreement].” Although the
`regulatory scheme in Cooling Water is different than that at issue here, it did not establish that pre-violation
`oversight is re