Center for Food Safety et al v. Price et al

Filing 100

OPINION AND ORDER: re: 65 MOTION for Summary Judgment filed by Center for Food Safety, Environmental Defense Fund, 74 CROSS MOTION for Summary Judgment filed by Tom Price, United States Food and Drug Administration, Scott Gottlieb. Accordingly, because I find that the GRAS Rule (1) does not unlawfully subdelegate FDA's duty to ensure food safety; (2) does not exceed FDA's statutory authority; (3) does not constitute arbitrary and capricious agency action in violation of the FDCA and APA; and (4) does not conflict with the FDCA, Plaintiffs' motion for summary judgment is DENIED, and the Government's motion for summary judgment is GRANTED. The Clerk of Court is respectfully directed to terminate docket entries 65 and 74, and to close this case. SO ORDERED. (Signed by Judge Vernon S. Broderick on 9/30/2021) (ama) Transmission to Orders and Judgments Clerk for processing.

Case 1:17-cv-03833-VSB Document 100 Filed 09/30/21 Page 1 of 35

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
---------------------------------------------------------- X
:
CENTER FOR FOOD SAFETY, BREAST
:
CANCER PREVENTION PARTNERS,
:
CENTER FOR SCIENCE IN THE PUBLIC
:
INTEREST, ENVIRONMENTAL DEFENSE :
FUND, and ENVIRONMENTAL WORKING :
GROUP,
:
:
Plaintiffs,
:
:
- against :
:
:
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. :
:
---------------------------------------------------------- X
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

9/30/2021

17-CV-3833 (VSB)
OPINION & ORDER

Case 1:17-cv-03833-VSB Document 100 Filed 09/30/21 Page 2 of 35

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:
What do enzyme-treated pea protein, oat polar lipid extract, rice bran wax, and refined
shea butter have in common? These are substances that manufacturers have concluded to be
generally recognized as safe (“GRAS”) for their prescribed uses in food.1 Such substances—
substances generally recognized as safe—are at the heart of this case.
Plaintiffs Center for Food Safety (“CFS”) and Environmental Defense Fund (“EDF”)
bring this action seeking declaratory and injunctive relief with respect to a final rule promulgated
by the United States Food and Drug Administration (“FDA”) entitled “Substances Generally
Recognized as Safe,” 81 Fed. Reg. 54,960 (Aug. 17, 2016) (the “GRAS Rule”). Plaintiffs move
for summary judgment on the grounds that the GRAS Rule (1) unlawfully subdelegates FDA’s
duty to ensure food safety in violation of the United States Constitution (the “Constitution”), the
Administrative Procedure Act (“APA”), and the Federal Food, Drug, and Cosmetic Act
(“FDCA”); (2) exceeds FDA’s statutory authority and constitutes arbitrary and capricious agency
action in violation of the FDCA and APA; and (3) conflicts with the FDCA. Defendants Xavier

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).

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Becerra, Secretary of Health and Human Services; Janet Woodcock, Commissioner of Food and
Drugs; and FDA, (collectively, the “Government”), cross-move for summary judgment arguing
that the GRAS Rule is a lawful exercise of FDA’s authority under the FDCA, and is not
unconstitutional.2
Because I find that FDA did not unlawfully subdelegate its authority, that the GRAS Rule
passes muster under the standards set forth in Chevron U.S.A., Inc. v. Natural Res. Def. Council,
Inc. (“Chevron”), 467 U.S. 837, 845 (1984), and Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State
Farm Mut. Auto. Ins. Co., (“State Farm”), 463 U.S. 29, 43 (1983), and that it does not conflict
with the FDCA, the Government’s motion for summary judgment is GRANTED. Plaintiffs’
motion is DENIED.
Background3
A.

The Food Additives Amendment

The FDCA requires FDA to “protect the public health by ensuring that . . . foods are safe,
wholesome, sanitary, and properly labeled.” 21 U.S.C. § 393(b)(2). In 1958, Congress enacted
the Food Additives Amendment to the FDCA (the “Food Additives Amendment”), Pub. L. No.
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.

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chemicals in foods and food processing,” 81 Fed. Reg. at 54,963. The purpose of the Food
Additives Amendment is “to prohibit the use in food of additives which have not been
adequately tested to establish their safety.” 72 Stat. 1784.
The Food Additives Amendment mandates that any “food additive” must go through an
approval process. See 21 U.S.C. § 348(b)–(g). Under this process, “the burden is on the
manufacturer to prove the safety of the use of the substance,” and “FDA must review and
approve the proposed use before the additive can be used in food.” (Compl. ¶ 36.) FDA
considers, among other things, “the probable consumption of the additive and of any substance
formed in or on food because of the use of the additive,” and “the cumulative effect of such
additive in the diet of man or animals, taking into account any chemically or pharmacologically
related substance or substances in such diet.” 21 U.S.C. § 348(c)(5).
The Food Additives Amendment provides a role for the public in the approval of food
additives. See generally 21 U.S.C. § 348. Specifically, it requires that FDA publish notice of a
proposed food additive regulation and the agency’s final decision on the underlying petition. Id.
§ 348(b), (c), (e). Any person adversely affected by FDA’s final decision may file objections
and request a public hearing, and the final decision is subject to judicial review. Id. § 348(f)–(g).
The Food Additives Amendment defines a “food additive” to include “substance the
intended use of which results or may reasonably be expected to result, directly or indirectly, in its
becoming a component or otherwise affecting the characteristics of any food.” 21 U.S.C. §
321(s). This definition exempts a category of substances that are:
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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Id. Based on the GRAS exemption to the Food Additives Amendment, described above,
substances such as vinegar, vegetable oil, baking powder, and many spices, flavors, gums, and
preservatives are lawfully marketed today. 81 Fed. Reg. at 54,963. After the passage of the
Food Additives Amendment, FDA “clarified the regulatory status of a multitude of food
substances that were used in food prior to 1958 and amended . . . regulations to include a list of
food substances that, when used for the purposes indicated and in accordance with good
manufacturing practice, are GRAS.” Id.; see 21 C.F.R. § 184.1005 et seq. (listing GRAS
substances). FDA, however, acknowledged that it would be impractical to list all GRAS
substances. 81 Fed. Reg. at 54,963; see 21 C.F.R. § 182.1(a). Procedurally, the Food Additives
Amendment does not require FDA to conduct a premarket review of whether the use of a
substance is GRAS. See 81 Fed. Reg. at 54,963.
B.

History of the GRAS Rule

Prior to the GRAS Rule, manufacturers could file a petition requesting a non-binding
“‘opinion letter,’ in which Agency officials would render an informal opinion on the GRAS
status of use of a substance.” 81 Fed. Reg. at 54,963. Subsequently, FDA instituted a voluntary
GRAS affirmation process under which manufacturers could ask FDA to affirm the GRAS status
of a particular use of a substance, thereby confirming that the substance was not a food additive
under the FDCA. 81 Fed. Reg. at 54,963–64. In so doing, manufacturers would provide FDA
with certain information, including “information to establish the safety and functionality of the
substance in food.” 21 C.F.R. § 170.35(c)(1) (reserved by 81 Fed. Reg. 54,960). Within thirty
days of the filing, FDA was required to publish a notice of filing in the Federal Register and
allow a sixty-day comment period. Id. § 170.35(c)(2), (c)(4). FDA could then either publish an
order that added the substance to the list of affirmed GRAS substances or publish a ruling that

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the substance was not GRAS and therefore a food additive. Id. § 170.35(c)(5), (c)(6). This
GRAS affirmation process “involved the resource-intensive rulemaking process.” 81 Fed. Reg.
at 54,964.
In April 1997, FDA proposed “to: (1) [c]larify the criteria for eligibility for classification
as GRAS;” “and (2) replace the GRAS affirmation petition process with a notification procedure
whereby any person may notify [the FDA] of a conclusion that a particular use of a substance is
GRAS.” Id. From 2008 to 2010, the Government Accountability Office (“GAO”) conducted a
study related to ingredients used in human food on the basis of the GRAS provision. Id. In
2010, GAO issued a report (“GAO Report”) that raised concerns about the proposed GRAS Rule
and proposed recommendations for FDA, including that FDA finalize the proposed GRAS Rule
and seek to minimize the potential for conflicts of interest in GRAS determinations. (See AR
008470–8543); U.S. Gov’t Accountability Off., GAO-10-246, FDA Should Strengthen Its
Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS) (2010).
In 2010, the comment period for the proposed rule was reopened to update comments and seek
additional comments on specific issues, including those raised by GAO. 81 Fed. Reg. at 54,964.
The proposed rule “invited interested persons to notify [FDA] about their conclusions of GRAS
status as described in the proposed rule.” Id.
FDA operated under the proposed GRAS Rule for nineteen years before publishing the
final GRAS Rule on August 17, 2016. (Compl. ¶¶ 51, 53); see 81 Fed. Reg. 54,960. The final
GRAS Rule codified FDA’s practice of allowing any person to notify FDA that a particular use
of a substance is GRAS. See id. at 54,966.

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C.

The GRAS Rule

Under the GRAS Rule, “[a]ny person may notify FDA of a view that a substance is not
subject to the premarket approval requirements of section 409 of the Federal Food, Drug, and
Cosmetic Act based on that person’s conclusion that the substance is GRAS under the conditions
of its intended use.” 21 C.F.R. § 170.205. The GRAS Rule provides two ways for
demonstrating GRAS status. The first is through “scientific procedures,” which must be “the
same quantity and quality of scientific evidence as is required to obtain approval of a food
additive.” 21 C.F.R. § 170.30(b). GRAS conclusions under this provision “shall be based upon
the application of generally available and accepted scientific data, information, or methods,
which ordinarily are published, as well as the application of scientific principles, and may be
corroborated by the application of unpublished scientific data, information, or methods.” Id.
The second mechanism is for substances used in food prior to January 1, 1958, and requires that
a showing be made “through experience based on common use in food.” Id. § 170.30(a).
If a person chooses to submit a GRAS notice,4 the person providing such notice must
include the following information: (1) signed statements identifying the substance, its intended
conditions of use, the basis for the GRAS status, and a certification that the notice is a complete,
representative, and balanced submission, 21 C.F.R. § 170.225; (2) the identity, method of
manufacture, specifications, and physical or technical effects, id. § 170.230; (3) information
about dietary exposure, id. § 170.235; (4) information about any self-limiting levels of use,
including a level at which the substance would become unpalatable or technologically
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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in food before 1958, id. § 170.245; (6) a narrative of the basis for the GRAS conclusion, id. §
170.250; and (7) a list of supporting data and information in the notice, specifying which data are
generally available, id. § 170.255.
Within 180 days of a GRAS notice, with the opportunity for a 90-day extension, the FDA
will respond to the person who provided notice based on its “evaluation of [the] notice.” Id. §
170.265(b). FDA will respond in one of three ways: (1) a letter stating FDA does not question
the basis for the GRAS determination; (2) a letter stating that FDA concludes that the notice does
not provide a sufficient basis for a GRAS determination; or (3) a letter stating that at the
notifier’s request, FDA has ceased to evaluate the GRAS notice. About the GRAS Notification
Program, U.S. Food and Drug Admin., https://www.fda.gov/food/generally-recognized-safegras/about-gras-notification-program (last visited Sept. 30, 2021). Before FDA’s response, a
person who submitted notice may request in writing that FDA cease to evaluate her GRAS
notice. 21 C.F.R. § 170.260(b). Under the GRAS Rule, FDA makes publicly available “[a] list
of filed GRAS notices, including [certain] information” included in the notice and “[t]he text of
any letter” FDA issues, including any letter issued when granting a request to cease evaluating a
notice. Id. § 170.275(b). Other information in a GRAS notice is subject to disclosure under the
Freedom of Information Act. Id. § 170.275(a).
The GRAS Rule’s notification process is voluntary. See 81 Fed. Reg. 54,960 (FDA noted
that it was “amending [its] regulations to replace the voluntary GRAS affirmation petition
process with a voluntary notification procedure under which any person may notify [FDA] of a
conclusion that a substance is GRAS under the conditions of its intended use.”). FDA, however,
retains authority to take various actions, including issuing warnings and stopping distribution,
when a substance does not qualify for GRAS status. Id. at 54,980–81.

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Procedural History
On May 22, 2017, Plaintiffs—a group of nonprofit advocacy organizations—filed this
action seeking a declaratory judgment that the GRAS Rule (1) violates fundamental principles of
separation of powers; (2) exceeds FDA’s statutory authority; (3) does not accord with the law;
(4) is arbitrary and capricious; and (5) is an abuse of discretion. (Compl. ¶¶ 14, 19–28.)
Plaintiffs also seek equitable relief vacating the GRAS Rule and directing FDA to reissue a rule
that is in accordance with the FDCA. (Id. ¶ 14.)
On September 22, 2017, the Government filed a motion to dismiss for lack of jurisdiction
pursuant to Federal Rule of Procedure 12(b)(1), (Doc. 30), which was fully briefed in November
2017, (see Docs. 31, 35, 36). On September 12, 2018, I issued an Opinion & Order denying the
Government’s motion as to Plaintiffs CFS and EDF because they had standing to pursue their
claims based on harm to their members, and granting the Government’s motion as to Plaintiffs
Breast Cancer Prevention Partners, Center for Science in the Public Interest, and Environmental
Working Group. (Doc. 44.)
After extending the Government’s time to answer, (Doc. 47), the Government answered
on October 4, 2018, (Doc. 50). I subsequently endorsed the parties’ proposed schedule for
production of the Record and summary judgment briefing. (Doc. 52.) Thereafter, I granted
Plaintiffs’ request for an extension of time to advise the Government that they were satisfied that
the Record was complete. (Doc. 59). In December 2018, this case was stayed due to a lapse in
funding to the United States Department of Justice. (Doc. 60.) The government shutdown ended
on January 25, 2019, and funding was restored. On February 19, 2019, the Government filed a
joint letter stating that “Plaintiffs [] advised the government that they will not file any motions to
complete or supplement the record”, and proposing that Plaintiffs’ summary judgment deadline

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be set for March 26, 2019, which was 60 days after the government shutdown ended. (Doc. 63.)
I granted this request. (Doc. 64.)
On March 26, 2019, Plaintiffs filed a motion for summary judgment, a memorandum of
law in support of their motion, and five declarations in support. (Docs. 65–71.) Subsequently, I
extended the remaining briefing deadlines. (Doc. 73.) On June 17, 2019, the Government filed a
cross motion for summary judgment and a memorandum of law in support. (Docs. 74–75.) In
July of 2019, Safe Food Ingredients Coalition (“SFIC”) requested that I grant it leave to file a
brief as amicus curiae in support of the Government’s cross-motion. I granted the request and
directed SFIC to file it amicus brief by July 26, 2019, (Doc. 76), which it did, (Doc. 83.) On
August 23, 2019, Plaintiffs filed their opposition to the Governments’ cross-motion. (Doc. 85.)
After granting the Government’s extension request, (Doc. 87), and request to file excess pages,
(Doc. 89), the Government filed its reply, (Doc. 90). On October 2, 2020, Plaintiffs requested
oral argument, (Doc. 91), and I denied Plaintiffs’ request on October 7, 2020, (Doc. 92).
On July 23, 2021, I issued an order explaining that it was unclear based on the docket
whether the parties provided me with the Record. (Doc. 95.) I directed the parties to inform me
whether they did in fact provide me with the Record, and if so, to provide me with another copy
of the Record, by on or before July 30, 2021. (Id.) If the parties had not provided me with the
record, I directed them to file a certified index of the Record, and a joint appendix containing
only the cited portions of the Record, by on or before August 6, 2021. The parties filed a letter
indicating that after reviewing the case file, the Government could not conclusively determine
whether it previously provided a copy of the administrative record to chambers. (Doc. 96.) The
Government indicated it would file the index of the complete administrative record, including a
certification; and a special appendix including only those documents in the record that either

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party cited in their briefing. (Id.) The parties also proposed to provide a copy of the full record
on compact disk (“CD”) to chambers and to send an additional copy of the same CD to the Clerk
of Court to maintain. (Doc. 96.) I endorsed the parties’ proposed plan for submitting the record.
(Doc. 98.) The Government filed the appendix containing cited excerpts of the record and a
certified index of the complete administrative record. (Docs. 97, 99.) The entire Record was
provided to me on a CD.
Legal Standard
Under Federal Rule of Civil Procedure 56, summary judgment is appropriate when “the
parties’ submissions show that there is no genuine issue as to any material fact and the moving
party is entitled to judgment as a matter of law.” Fay v. Oxford Health Plan, 287 F.3d 96, 103
(2d Cir. 2002); see also Fed. R. Civ. P. 56(a). “When a party seeks review of agency action
under the APA, the ‘entire case on review is a question of law’ such that ‘judicial review of
agency action is often accomplished by filing cross-motions for summary judgment.’” Just
Bagels Mfg., Inc. v. Mayorkas, 900 F. Supp. 2d 363, 372 (S.D.N.Y. 2012) (quoting Connecticut
v. U.S. Dep’t of Commerce, No. 3:04cv1271 (SRU), 2007 WL 2349894, at *1 (D. Conn. Aug.
15, 2007)). Accordingly, “the usual Rule 56 summary judgment standard does not apply in such
cases, because the court is resolving legal questions when it determines if the agency acted in
excess of statutory authorization, not in accordance with law, arbitrarily and capriciously, or in
some other way that violates 5 U.S.C. § 706.” New York v. U.S. Dep’t of Health & Human
Servs., 414 F. Supp. 3d 475, 516 (S.D.N.Y. 2019) (internal quotation marks omitted).
“Generally, a court reviewing an agency decision is confined to the administrative record
compiled by the agency when it made the decision.” Id. at 517 (internal quotation marks
omitted).

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Discussion
Plaintiffs argue that the GRAS Rule (1) unlawfully subdelegates FDA’s duty to ensure
food safety in violation of the Constitution, the APA, and the FDCA; (2) exceeds FDA’s
statutory authority, and constitutes arbitrary and capricious agency action in violation of the
FDCA and APA; and (3) conflicts with the FDCA. The Government cross-moves for summary
judgment essentially arguing the opposite: that the GRAS Rule is a lawful exercise of FDA’s
authority under the FDCA and is not unconstitutional.
A. Subdelegation Challenge
1. Applicable Law
“An agency impermissibly delegates its authority where, without statutory
authorization, ‘it shifts to another party almost the entire determination of whether a specific
statutory requirement . . . has been satisfied, or where it abdicates its final reviewing authority.’”
Cooling Water Intake Structure Coal. v. U.S. Envtl Prot. Agency, 905 F.3d 49, 79 (2d Cir. 2018)
(quoting Fund for Animals v. Kempthorne, 538 F.3d 124, 133 (2d Cir. 2008)); see also United
States Sec. & Exch. Comm’n v. Alpine Sec. Corp., 982 F.3d 68, 81 (2d Cir. 2020). Although
“[a]gencies may seek advice and policy recommendations from outside parties, . . . they may not
‘“rubber-stamp” decisions made by others under the guise of seeking their “advice”.’” Fund for
Animals, 538 F.3d at 133 (quoting U.S. Telecom Ass’n v. FCC, 359 F.3d 554, 568 (D.C. Cir.
2004)).
As the D.C. Circuit has explained, there is a distinction between a subdelegation to a
subordinate federal officer or agency and subdelegation to an outside party. See U.S. Telecom
Ass’n, 359 F.3d at 565.
[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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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.
Id. at 565–66 (internal citations and quotation marks omitted). In other words, “subdelegation to
outside entities aggravates the risk of policy drift inherent in any principal-agent relationship.”
Id. at 566.
2. Application
Plaintiffs argues that “Congress delegated to FDA the responsibility of ensuring that our
nation’s food is safe and free from harmful substances” and that the GRAS Rule “unlawfully
subdelegates—or shifts—to manufacturers this core governmental duty, allowing them to decide
for themselves, in secret, whether the chemical substances they have synthesized may be added
to food.” (Pls.’ Mot. 8.)5 Plaintiffs broadly assert separation of powers concerns. (See id. at 8–
14.) The Government responds that contrary to Plaintiffs’ framing of the issue, subdelegation
claims are treated as statutory, not constitutional claims, and regardless, Plaintiffs’ claim fails
because the GRAS Rule does not subdelegate agency authority.6 (Govt. Mot. 18.)7
In Fund for Animals, the Second Circuit held that a depredation order which authorized
“State fish and wildlife agencies, Federally recognized Tribes, and State Directors of the Wildlife
Services program . . . to prevent depredations on the public resources of fish . . . , wildlife, plants,
and their habitats by taking without a permit double-crested cormorants found committing or
about to commit, such depredations” did not unlawfully subdelegate the responsibility of the Fish

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
(“MBTA”). 538 F.3d at 130, 133 (internal quotation marks omitted). The Second Circuit
explained that:
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.”
Id. at 133. Additionally, the Second Circuit observed that unlike the process for issuing
depredation permits, which requires that FWS affirmatively issue a permit or order before
any depredation control occurs, the Depredation Order allows the parties to provide such
information after the fact. Id.; see id. at 130 (Depredation Order requires a yearly notice
for those years in which the agency intends to act and annual reports describing their
activities under the Depredation Order). The Second Circuit noted, “[t]here is, however,
no statutory requirement that the FWS provide prior authorization in the form of a permit
for specific takings of migratory birds. The MBTA mandates only ‘suitable regulations
permitting and governing’ takings. The regulations restricting the taking of migratory
birds, even in the absence of an advance permitting scheme, satisfy this statutory
requirement.” Id. at 133 (internal citation omitted).
As the Government correctly points out, “the FDCA does not impose mandatory
GRAS notification on manufacturers or require FDA to review industry GRAS
conclusions in advance of marketing.” (Govt. Mot. 18.) Instead, FDA has the power to
take enforcement action if it does not agree with a person’s GRAS determination. See 81
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
GRAS].” 538 F.3d at 131. Although in Fund for Animals, the FWS did retain some
authority to regulate takings before they occurred, Plaintiffs are incorrect that the Second
Circuit “premised its approval on the existence of pre-violation oversight mechanisms,”
(Pls.’ Opp. 9)8; instead, the court explicitly held 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 133.9
Plaintiffs’ argument here is even less compelling than plaintiffs’ argument in
Fund for Animals. Congress delegated “to FDA the responsibility of ensuring that our
nation’s food is safe and free from harmful substances.” (Pls.’ Mot. 8 (citing 72 Stat.
1784; 21 U.S.C. § 393(b)).) If the FDA has delegated anything at all to manufacturers, it
is simply the ability to notify FDA of a GRAS determination, with which FDA can agree
or disagree. “[T]he authority delegated by Congress to the [FDA] . . . bears little
resemblance to the far narrower band of discretion afforded to those acting under the
[GRAS Rule].” Fund for Animals, 538 F.3d at 133. As the Government aptly notes, “[i]f

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 required to survive a subdelegation challenge.

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FDA had promulgated no rule at all, manufacturers would have the same option they
have now: to act without notifying FDA and assume the risk of enforcement if FDA later
determines that they violated the law. The Rule provides them no additional authority.”10
(Govt. Reply 9.)11 This is due, at least in part, to the fact that the law does not require
manufacturers to get preapproval before using a substance the manufacturer believes to
be GRAS.
Plaintiffs contend that the GRAS Rule fails to ensure that FDA retains oversight
over GRAS determinations and therefore the public cannot hold FDA accountable for the
safety of substances, leaving the public with no recourse. (Pls.’ Mot. 11–13.) Plaintiffs
aver that “[w]hen actions that Congress delegated to an executive agency—such as
decisions about what chemical substances can be added to food—are shielded from
judicial review, separation of powers principles are violated.” (Id. at 13.) According to
Plaintiffs, this is exacerbated by the potential conflicts of interest that may arise during
GRAS determinations. (Id.) Although Plaintiffs’ assertions do raise legitimate concerns,
here, FDA retains the power to disagree with manufacturers’ GRAS determinations and
bring enforcement actions. See 81 Fed. Reg. at 54,963; (AR 8649–56, 8662–66). The
FDCA does provide for certain ways for the public to participate in the food additive

10
Plaintiffs also contend that “FDA misstates the function of the Second Circuit tests as asking whether a
subdelegation has occurred at all, rather than evaluating whether a subdelegation is permissible.” (Pls.’ Opp. 7 n.3
(internal quotation marks omitted)). In Fund for Animals, the Second Circuit explained that because the MBTA did
not explicitly provide for delegation to third parties, the court’s “inquiry focuses on whether the Depredation Order
is, in fact, such a delegation” because any delegation would be impermissible. 538 F.3d at 132–33. Regardless of
whether I ask whether a delegation occurred or whether a delegation was impermissible, my determination is the
same—FDA has not unlawfully delegated its authority. Plaintiffs dedicate time to arguing that “FDA’s
subdelegation in no way qualifies as one of the three types of ‘legitimate outside party input into agency decisionmaking processes’ recognized by the courts.” (Pls.’ Mot. 14 (citing U.S. Telecom Ass’n, 359 F.3d at 566).) Given
that I find that FDA has not unlawfully delegated its authority, I find it unnecessary to delve into whether the GRAS
Rule falls within the exceptions laid out by Plaintiffs.
11

“Govt. Reply” refers to the Government’s reply memorandum of law in further support of its cross-motion for
summary judgment, filed on September 19, 2019. (Doc. 90.)

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process, see 21 U.S.C. § 348(b)(5), (f)(1), (g); however, there is nothing within the
statutory scheme to require FDA to make GRAS determinations so that such
determinations can be challenged in court. Other than prudential concerns and citations
to inapposite case law, Plaintiffs provide no legal support for their argument that the
GRAS Rule violates the Constitution by adopting a voluntary notification system and
allowing post-violation, instead of pre-violation enforcement.12 Moreover, FDA uses a
similar voluntary notification system to regulate the marketing of cosmetics.13
Accordingly, I find that the GRAS Rule is not an unlawful subdelegation of FDA’s
authority.
B.

Challenge Under the Administrative Procedure Act

Plaintiffs appear to challenge the GRAS Rule under the standards set forth in Chevron
and State Farm. (See Pls.’ Opp. 22.) As explained more fully below, I will analyze the GRAS
Rule under both standards.14

12

Plaintiffs’ citations on this point are unpersuasive or non-binding. (See, e.g., Pls.’ Mot. 13–14 (citing Connecticut
v. Am. Elec. Power Co., Inc., 406 F. Supp. 2d 265, 267 (S.D.N.Y. 2005) (broadly describing the separation of
powers principle), vacated and remanded, 582 F.3d 309 (2d Cir. 2009), rev’d, 564 U.S. 410 (2011); Defs. of Wildlife
v. Gutierrez, 532 F.3d 913, 926 (D.C. Cir. 2008); Nat’l Park & Conservation Ass’n v. Stanton, 54 F. Supp. 2d 7, 18
(D.D.C. 1999)); Pls.’ Opp. 10 (citing R.H. Johnson & Co. v. SEC, 198 F.2d 690, 695 (2d Cir. 1952) (no
unconstitutional delegation of legislative power)).

13

See Voluntary Cosmetic Registration Program, U.S. Food and Drug Admin.,
https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program (last visited Sept. 30, 2021) (explaining
that the program “assists FDA in carrying out its responsibility to regulate cosmetics marketed in the United States.
Because [cosmetic] product filings and establishment registrations are not mandatory, voluntary submissions
provide FDA with the best estimate of information available about cosmetic products and ingredients, their
frequency of use, and businesses engaged in their manufacture and distribution.”).
14

Although it may make sense to conduct a State Farm analysis before Chevron because if a “State Farm challenge
is successful there is no need for the reviewing court to engage in Chevron analysis,” Catskill Mountains Chapter of
Trout Unlimited, Inc. v. EPA, 846 F.3d 492, 522 (2d Cir. 2017), here, because Plaintiffs’ challenge is more properly
a Chevron challenge, I consider it first. I also note that because I conduct a searching review of FDA’s rationale
during my Chevron analysis, I find it practical to conduct that analysis first.

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1. Chevron Analysis
a. Applicable Law
Chevron sets forth a two-step framework. At Chevron Step One, the court asks “whether
Congress has directly spoken to the precise question at issue.” 467 U.S. at 842. “If the intent of
Congress is clear, that is the end of the matter; for the court, as well as the agency, must give
effect to the unambiguously expressed intent of Congress.” Id. at 842–43. If, however, the
statutory language is “silent or ambiguous,” the court proceeds to Chevron Step Two, where “the
question for the court is whether the agency’s answer is based on a permissible construction of
the statute.” Id. at 843. “If it is—i.e., if it is not ‘arbitrary, capricious, or manifestly contrary to
the statute,’—[the court] will accord deference to the agency’s interpretation of the statute so
long as it is supported by a reasoned explanation, and ‘so long as the construction is a reasonable
policy choice for the agency to make.’” Catskill Mountains Chapter of Trout Unlimited, Inc. v.
EPA, 846 F.3d 492, 507 (2d Cir. 2017) (quoting Chevron, 467 U.S. at 844 and Nat’l Cable &
Telecomms. Ass’n v. Brand X Internet Servs., 545 U.S. 967, 986 (2005)). Therefore, the
principal question, whether FDA’s interpretation of the FDCA, as embodied in the GRAS Rule,
is consistent with the FDCA, must be analyzed under the two-step framework set forth in
Chevron.
b. Application
i.

Chevron Step One

The question before me under Chevron Step One is whether the FDCA requires that FDA
be made aware of GRAS conclusions. Plaintiffs contend that the GRAS Rule fails at Step 1
because it “contravenes . . . plain statutory language” by “allow[ing] manufacturers to make
secret safety determinations.” (Pls.’ Mot. 16.) In other words, because manufactures do not

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have to disclose GRAS determinations, “FDA cannot possibly assess the risks that new uses of
food additives might pose in combination with ‘chemically or pharmacologically related
substances’ in our diets, despite its statutory duty to do so.” (Id. at 16–17 (quoting 21 U.S.C. §
348(c)(5)(B).) The Government argues that the FDCA is silent on whether the manufacturer
must notify FDA of GRAS conclusions. (Govt. Mot. 10.)
To resolve this question, I employ “traditional tools of statutory construction,” Catskill
Mountains, 846 F.3d at 508 (internal quotation marks omitted), and “examine the statutory text,
structure, and purpose as reflected in its legislative history,” id. at 512. “As with any question of
statutory interpretation, [I] begin with the text of the statute to determine whether the language at
issue has a plain and unambiguous meaning.” Id. (internal quotation marks omitted).
Plaintiffs argue that the statutory text specifically speaks on the issue because the Food
Additives Amendment requires that in order to determine whether a food additive is safe, the
FDA “shall consider . . . the cumulative effect of such additive in the diet of man or animals,
taking into account any chemically or pharmacologically related substance or substances in such
diet,” 21 U.S.C. § 348(c)(5)(B), and the FDA cannot make this determination without
information about current exposures to substances already present in food, (see Pls.’ Mot. 16–
17). Plaintiffs’ strained interpretation is unpersuasive—this language does not have an
“unambiguous meaning,” Catskill Mountains, 846 F.3d at 512 (internal quotation marks
omitted); it is dubious to think that Congress used such language to require manufacturers to
inform FDA of GRAS determinations without explicitly saying so. Congress “does not, one
might say, hide elephants in mouseholes.” Whitman v. Am. Trucking Ass’ns, Inc., 531 U.S. 457,
468 (2001).
The FDCA broadly requires FDA to “protect the public health by ensuring that . . . foods

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are safe, wholesome, sanitary, and properly labeled.” 21 U.S.C. § 393(b)(2). This mandate cuts
in favor of Plaintiffs’ argument, as FDA may be hindered in carrying out this objective if it does
not have access to all GRAS determinations. On the other hand, the Food Additives Amendment
establishes a rigorous statutory scheme for approving food additives, see id. § 348(b)–(g), but
GRAS substances are specifically exempted from this scheme, id. § 321(s). This exemption
lessens the requirements applicable to GRAS determinations. See 81 Fed. Reg. at 54,981–82
(responding to comments regarding mandatory GRAS notifications, and “agree[ing] that [FDA]
lacks express statutory authority to require companies to submit GRAS notices.”). In other
words, the statutory text does not indicate that Congress “clearly spoke to the precise question at
issue.” Catskill Mountains, 846 F.3d at 514.
I next consider Congress’s purpose in enacting the Food Additives Amendment. The
purpose of the Amendment was “to protect the public health by amending the Federal Food,
Drug, and Cosmetic Act to prohibit the use in food of additives which have not been adequately
tested to establish their safety,” 72 Stat. 1784, and was “in response to public concern about the
increased use of chemicals in foods and food processing and with the support of the food
industry,” 81 Fed. Reg. at 54,962. As Plaintiffs note, the GRAS Rule may undermine this
purpose, as substances could potentially be included in food that have not been adequately tested,
of which FDA is unaware. However, as noted above, although the Food Additives Amendment
establishes a rigorous statutory scheme for approving food additives, GRAS substances are
specifically exempted from this scheme. In addition, as the Government correctly points out,
“no law pursues its purpose at all costs,” Rapanos v. United States, 547 U.S. 715, 752 (2006),
and the FDCA explicitly provides FDA “the authority to promulgate regulations for . . . efficient
enforcement,” 21 U.S.C. § 371(a). In short, an analysis of the “statutory text, structure, and

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purpose as reflected in its legislative history,” Catskill Mountains, 846 F.3d at 512, reveals that
Congress did not in the FDCA speak directly to the question of whether GRAS notifications
must be mandatory. The FDCA “is therefore silent or ambiguous as to this question, which
means that this case cannot be resolved by the Step One analysis under Chevron.” Id. at 519.
Therefore, I proceed to Step Two.
ii.

Chevron Step Two

Plaintiffs argue that the GRAS Rule is unlawful at Step Two because “it rests on an
impermissible statutory construction” and “fails to address important aspects of food safety
documented in the record.” (Pls.’ Mot. 19.) The Government responds that FDA is engaging in
proper gap filling and “FDA has reasonably determined that a voluntary notice submission
regime for GRAS substances, rather than a preapproval process with mandatory submissions,
constitutes the best use of its resources to effectuate Congressional intent and the core statutory
purpose.” (Govt. Mot. 12.) The Government is correct.
At Step Two, I “deem Congress to have delegated the resolution of statutory ambiguity to
the administering agency, so that [my] judicial task is simply to determine ‘whether the agency’s
answer is based on a permissible construction of the statute.’” New York v. FERC, 783 F.3d 946,
954 (2d Cir. 2015) (quoting Chevron, 467 U.S. at 843). “That inquiry is deferential, asking only
whether the agency’s interpretation is ‘reasonable,’ while ‘respecting legitimate policy choices’
made by the agency.” Id. (quoting Chevron, 467 U.S. at 866) (collecting cases); Catskill
Mountains, 846 F.3d at 520 (“Generally, an agency interpretation is not arbitrary, capricious, or
manifestly contrary to the statute if it is reasonable.” (internal quotation marks omitted)).
First, I consider whether FDA has provided a reasoned explanation for its decision to not
require mandatory GRAS notifications. See id. at 524. I find that FDA has done so. In

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promulgating the GRAS Rule, FDA clearly considered whether to make GRAS notifications
mandatory—an issue that was raised by numerous comments during consideration of the GRAS
Rule. See 81 Fed. Reg. at 54,964–65, 54,979, 54,981–82. In response to comments asserting
that a voluntary notification system would violate the Food Additives Amendment, FDA
explained that although the FDCA provides for its review of food additives, “it is silent with
respect to industry submissions to us on the use of GRAS substances.” Id. at 54,971 (Response
1). In response to other similar comments, FDA explained:
We agree that we lack express statutory authority to require companies to submit
GRAS notices. In creating the premarket approval requirement for food additives
in the 1958 amendment, Congress excluded a substance that is GRAS under the
conditions of its intended use from the definition of food additive. The creation of
this GRAS provision reflected Congress’ determination that many substances
intentionally added to food for a specific use do not need premarket review by FDA
to ensure their safety, either because their safety has been established by a long
history of use in food, or because their safety has been established by information
that is generally available to and accepted by qualified experts, regarding the
intended conditions of use of a substance in food.
Id. at 54,981–82.
FDA noted that even without express authorization from the FDCA, it could potentially
make GRAS notifications mandatory, and commentators suggested that a mandatory system
would increase GRAS filings. See id. FDA considered these concerns and observed that even
under the voluntary system, the food industry had continued to actively submit GRAS notices.
Id. at 54,981 (Response 26). Such submissions increased in the years after the proposed GRAS
Rule was in place; between implementation of the proposed GRAS Rule and 2015, more than
600 GRAS notices were filed, resulting in an average of approximately 34 GRAS notices per
year. Id. Between 1987 and 1996, FDA received a total of fewer than 100 GRAS affirmation
petitions, with an average of approximately 8 GRAS affirmation petitions per year. Id.
Additionally, FDA observed that a voluntary notification system compared to the previous

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voluntary affirmation system would provide greater flexibility to respond to safety concerns. Id.
at 54,980 (Response 25). Unlike the affirmation process, responding to a safety issue related to a
GRAS substance would not require rulemaking. Id.
Finally, FDA concluded that mandatory submissions would consume FDA’s resources,
which could better be directed towards evaluating “more, and higher priority, substances.” See
id. at 54,961, 54,964 (observing that GRAS affirmation process “involved the resource-intensive
rulemaking process”), 55,030. FDA explained that instead of conducting a pre-market review,
safety concerns could be served by “issuing a [public] warning letter . . .; issuing a public alert;
taking enforcement action . . . ; and issuing a declaratory order determining that the substance is
not GRAS.” Id. at 54,981. Not only those who submit GRAS notices are subject to FDA’s
enforcement authority. For example, in 2013, FDA published a notice in the Federal Register
describing its findings that partially hydrogenated oils were not GRAS, and in 2015 issued a
declaratory order issuing a final determination that such substances were not GRAS. Id. at
54,965. Additionally, FDA issued warning letters related to the use of caffeine in alcohol,
resulting in the companies ceasing such distribution. Id.; (see AR 8649–56, 8662–66).
Based on the nineteen years operating under the proposed GRAS Rule, FDA concluded
that the “filing of more than 600 GRAS notices for substances used in human food is evidence
that the substitution of a GRAS notification procedure for the GRAS affirmation petition process
has benefits for consumers, FDA, the regulated industry, and other stakeholders.” 81 Fed. Reg.
at 54,966. It found that the notification procedure “increased [its] awareness of the composition
of the nation’s food supply and the dietary exposure to GRAS substances, which helps [FDA] to
ensure the safe use of substances added to food.” Id. I find that FDA’s rationale “was
sufficiently reasoned to clear Chevron’s rather minimal requirement that the agency give a

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reasoned explanation for its interpretation. [I] see nothing illogical in the [FDA]’s rationale.”
Catskill Mountains, 846 F.3d at 524 (finding EPA provided a reasoned explanation for its
decision to interpret the Clean Water Act to not require certain permits where EPA based the rule
on a “holistic interpretation of the Clean Water Act” taking into account “the statutory language,
the broader statutory scheme, the statute’s legislative history, [and] the EPA’s longstanding
position” on water transfers).
Next, I consider the reasonableness of FDA’s interpretation of the FDCA, see id. at 525,
and conclude that the FDA’s interpretation is reasonable. First, as I have noted throughout my
analysis, the FDCA is silent on whether GRAS notifications must be mandatory, and specifically
exempts GRAS substances from the pre-market review regime to which food additives are
subject. In promulgating the GRAS Rule, FDA noted that GRAS substances were excluded from
the food additives process, and it is entirely reasonable that FDA would view this as suggesting
Congress intended GRAS substances to be treated differently because Congress itself had done
so.
Second, FDA operated under the proposed GRAS Rule for nineteen years and during that
time, GRAS notices increased. When announcing the proposed GRAS Rule, FDA explained
with regards to the GRAS affirmation process, “FDA believes that, in practice, this resourceintensive process deters many persons from petitioning the agency to affirm their independent
GRAS determinations.” 62 Fed. Reg. 18,938, 18,941 (1997). Based on FDA’s history operating
under the proposed GRAS Rule, it is reasonable that FDA would believe that such a rule would
increase its awareness about the ingredients being put into food. Indeed, the increase in GRAS
notices as compared to GRAS affirmation petitions bears this out.
Third, as amicus curiae SFIC points out in its brief, FDA has a “long-standing record” of

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interpreting the FDCA to exempt GRAS substances from premarket review. (Amicus 6.)15
Indeed, the system in place before the GRAS Rule was also voluntary. See 81 Fed. Reg. at
54,960. Similarly, as the Government notes, Congress has amended the Food Additives
Amendment but has never amended the language to require mandatory GRAS submissions. (See
Govt. Mot. 14 (citing as examples Food Quality Protection Act of 1996, Pub. L. 104-170, 110
Stat. 1489 (amending 21 U.S.C. § 342(a)); Dietary Supplement Health and Education Act of
1994, Pub. L. 103-417, 108 Stat. 4325 (amending § 342(f)); Act of June 29, 1966, Pub. L. 89477, 80 Stat. 231 (amending § 342(d))). Plaintiffs respond that this argument fails because
“FDA fails to identify subsequent congressional action bearing on the meaning of the GRAS
exception or FDA’s statutory responsibilities,” and point out that the Government’s examples
occurred before the proposed GRAS Rule. (Pls.’ Opp. 21.) I find it unnecessary here to resolve
whether Congress has implicitly ratified FDA’s interpretation, but find it persuasive that
Congress has remained silent for more than sixty years on whether GRAS submissions should be
voluntary, and has amended the statute at issue when a voluntary system was in place. See
Catskill Mountains, 846 F.3d at 525 (noting that in the forty years since the passage of the Clean
Water Act, water transfers were never subject to a general permit requirement and therefore
“Congress . . . appears to have, however silently, acquiesced in this state of affairs.”).
Finally, it was reasonable for FDA to determine that its resources could better be
allocated to higher public health priorities. As SFIC’s brief explains, FDA regulates a large
percentage of the United States food supply, but less than a fifth of its budget is allocated to food
regulatory activities.16 (Amicus 11.) SFIC argues that “[t]he GRAS Notification program allows

15

“Amicus” refers to SFIC’s amicus brief, filed on July 26, 2019. (Doc. 83.)

16

As of November 2020, FDA regulated around 78 percent of the United States food supply, and 19 percent of its
budget is dedicated to food regulatory activities. Fact Sheet: FDA at a Glance, U.S. Food & Drug Admin. (last

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FDA to best direct these limited resources. Specifically, it not only allows FDA to focus on
higher priority food ingredients, but also other important health-related issues”, including foodborne illness and the safety of imported food. (Id. at 12.) SFIC also notes that a change to the
GRAS Rule would result in confusion and overwhelm FDA with reviewing the status of
countless ingredients that are being used in food. (Id. 12–13.) FDA’s determination that
resources could be conserved by taking enforcement action after the fact, instead of requiring
pre-market approval, is reasonable and commonplace in the administrative state. See Nat. Res.
Def. Council, Inc. v. U.S. Food & Drug Admin., 760 F.3d 151, 170–71 (2d Cir. 2014) (“Agencies
have many responsibilities, and limited resources. Deciding whether and when to deploy those
resources . . . is an important and difficult responsibility. It is rare that agencies lack discretion
to choose their own enforcement priorities.”).
In sum, I find FDA’s interpretation reasonable given that GRAS substances are
specifically exempted from the rigorous review applicable to food additives, GRAS submissions
increased under the proposed GRAS Rule, in more than sixty years Congress has never required
mandatory GRAS submissions, and that FDA has limited resources to allocate to food safety.
Plaintiffs assert numerous reasons why the GRAS Rule fails at Chevron Step Two. At
their core, however, Plaintiffs’ arguments boil down to the contention that if GRAS notifications
were mandatory, FDA could obtain all of the information it needs to make food safety
determinations before ingredients are placed into food. (Pls.’ Opp. 19.) As Plaintiffs suggest,
FDA could, for example, “require[e] any company that conducts a GRAS determination to
provide FDA with basic information . . . such as the substance’s identity and intended uses.”
(Pls.’ Opp. 18 (quoting AR 008507).) However, this is not the law. FDA’s interpretation need

updated Nov. 2020), https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance.

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not be “the only possible interpretation, nor even the interpretation deemed most reasonable by
the courts.” Entergy Corp. v. Riverkeeper, Inc., 556 U.S. 208, 218 (2009). Instead, it must
simply be a reasonable interpretation of the FDCA.
In further support of their arguments, Plaintiffs point to a comment made by the FDA’s
deputy commissioner in 2014, when the proposed GRAS Rule was in place, that “[FDA] simply
do[es] not have the information to vouch for the safety of many of the[] chemicals [added to
food]”, and that it is “the opposite of what [Congress] intended,” (Pls.’ Mot. 19–20 (quoting AR
008088, 8092) (alterations by Plaintiffs)17, and the GAO Report. The language quoted by
Plaintiffs comes from a 2014 Washington Post article exploring issues with the proposed GRAS
Rule. I note that the quote excerpted from the deputy commissioner appears to refer not
necessarily to the voluntary nature of the Rule being the problem, but rather the potential for
conflicts of interest and backdoor dealings. (See AR 008092 (“Although informing the FDA is
voluntary, he said, the law was meant to increase public scrutiny of additive safety by
encouraging companies to publish their science in academic journals. ‘The assessments need to
be based on publicly available information where there is agreement among scientists,’ he said.
‘It has got to be more than three employees in a room looking at information that is only
available to them.’”).) Nevertheless, the article and comments from the FDA’s deputy
commissioner do raise potential issues with the GRAS Rule, (see AR 008088–94); however,
these do not rise to the level of defeating Chevron deference. Instead, gap-filling the Food
Additives Amendment “involves difficult policy choices that agencies are better equipped to
make than courts.” Nat’l Cable, 545 U.S. at 980.

17

I note that the unaltered quotations read: “We simply do not have the information to vouch for the safety of many
of these chemicals” and “This is the opposite of what the overight law intended.” (AR 008088, 8092.)

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The GAO Report, titled: “FDA Should Strengthen Its Oversight of Food Ingredients
Generally Recognized as Safe,” (see AR 008470–8543), was critical of the proposed Rule’s
voluntary nature, and reported that “FDA generally does not have information about . . . GRAS
determinations because companies are not required to inform the agency of their GRAS
determinations.” (AR 008481.) GAO explained that without such information, FDA’s ability to
ensure food safety is hindered, and expressed concern over how FDA could conduct an audit of a
company if manufacturers are not subject to recordkeeping requirements. (See AR 008485,
8486, 008489.) In characterizing FDA’s response to the GAO Report, GAO noted that “[FDA’s]
comments suggest that FDA would prefer to make notifications mandatory,” however, GAO also
noted, that “[i]f this is FDA’s intended strategy in response to our recommendation, we
encourage the agency to seek legal authority from Congress, as needed, to implement this
approach.” (Id. at 8509.) After the GAO report, FDA reopened the comment period for the
proposed GRAS Rule, in part due to the findings in the GAO report. See 75 Fed. Reg. 81,536,
81,537 (Dec. 28, 2010).
Plaintiffs argue that although the GAO Report alerted FDA to the problems inherent
within the GRAS Rule, FDA ignored the Report, and “enacted the GRAS Rule, permitting
secrecy and undermining transparency.” (Pls.’ Mot. 18.) This argument is unpersuasive and
ignores the objective facts. As the Government correctly points out, FDA addressed the GAO
Report numerous times when enacting the GRAS Rule. See generally 81 Fed. Reg. at 54,960–
55,028 (mentioning GAO Report more than 10 times). In fact, FDA took steps recommended by
GAO, including issuing guidance on the use of nanotechnology, announcing its intent to issue
guidance on the potential for conflicts of interest, and reminding the food industry that the same
standards apply to a GRAS determination, regardless of whether such a determination is

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submitted to FDA. 81 Fed. Reg. at 54,964.
Finally, certain portions of the Record cited by Plaintiffs raise an issue inherent in this
case—the increase in processed foods and food additives. (See AR 8088) (“In the five decades
since Congress gave the FDA responsibility for ensuring the safety of additives in the food
supply, the number has spiked from 800 to more than 9,000, ranging from common substances
such as salt to new green tea extracts.”). I am cognizant of this reality, and of the fact that
circumstances have changed since the enactment of the Food Additives Amendment. Still, as
was recognized by both FDA and GAO, it remains unclear under the statute whether FDA even
has the authority to make GRAS notifications mandatory. I decline Plaintiffs’ invitation to
rewrite the statute. The remedy Plaintiffs seek lies with Congress, not me, and Congress has
chosen not to act despite the increase in the number of food additives over the last five decades.
In sum, because the GRAS Rule is “a reasonable construction of the [FDCA] supported
by a reasoned explanation, it survives deferential review under Chevron.” Catskill Mountains,
846 F.3d at 533.
2. State Farm Analysis
a. Applicable Law
Pursuant to the APA, a reviewing court may “hold unlawful and set aside agency action,
findings, and conclusions found to be . . . arbitrary [or] capricious.” 5 U.S.C. § 706(2)(A). In
State Farm the Supreme Court explained that:
an agency rule would be arbitrary and capricious [under § 706(2)(A)] if the agency
has relied on factors which Congress has not intended it to consider, entirely failed
to consider an important aspect of the problem, offered an explanation for its
decision that runs counter to the evidence before the agency, or is so implausible
that it could not be ascribed to a difference in view or the product of agency
expertise.
463 U.S. at 43.

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In Catskill Mountains, the Second Circuit declined to incorporate the State Farm standard
into the Chevron analysis. 846 F.3d at 521. The Court explained that “[a]n agency’s initial
interpretation of a statutory provision should be evaluated only under the Chevron framework,
which does not incorporate the State Farm standard” and that “State Farm review may be
appropriate in a case involving a non-interpretive rule or a rule setting forth a changed
interpretation of a statute.” Id. “State Farm is used to evaluate whether a rule is procedurally
defective as a result of flaws in the agency’s decisionmaking process. Chevron, by contrast, is
generally used to evaluate whether the conclusion reached as a result of that process—an
agency’s interpretation of a statutory provision it administers—is reasonable.” Id. (internal
citations omitted).
A litigant may bring a challenge under either standard or both. Id. There is typically
overlap between a Chevron Step Two analysis and State Farm analysis. Id. at 522 (collecting
cases). The Second Circuit has “in many . . . cases, . . . applied Chevron Step Two without
applying State Farm or conducting an exacting review of the agency’s decisionmaking and
rationale.” Id. at 522–23; see, e.g., Stryker v. SEC, 780 F.3d 163, 167 (2d Cir. 2015); Florez v.
Holder, 779 F.3d 207, 211–12 (2d Cir. 2015); Kar Onn Lee v. Holder, 701 F.3d 931, 937 (2d
Cir. 2012); Adams v. Holder, 692 F.3d 91, 95 (2d Cir. 2012).
b. Application
Plaintiffs argue that under State Farm, “FDA’s construction of the [FDCA] . . .
constitutes quintessential arbitrary and capricious rulemaking in violation of the APA because it
ignores important aspects of food safety, and is inconsistent with the weight of the evidence in
the record showing the dangers of this approach.” (Pls.’ Mot. 20; Pls.’ Opp. 22.) Plaintiffs aver
that FDA has more than 20 years of evidence of the GRAS Rule’s shortcomings yet did nothing

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to grapple with these concerns. (Pls.’ Mot. 20–21.) Plaintiffs cite to Nat. Res. Def. Council v.
U.S. E.P.A., 658 F.3d 200, 215–16 (2d Cir. 2011) (“NRDC”), in which the Second Circuit held
an agency’s action was arbitrary and capricious under State Farm where the agency failed to
provide an explanation for its action as was required by the statute at issue.
Plaintiffs’ citation to NRDC is misplaced. FDA’s actions here are not akin to those at
issue in NRDC. As I detailed in my Chevron analysis, supra IV.B.1.b, FDA provided numerous
cogent explanations for adopting the GRAS Rule—including the increase in GRAS submissions
under the proposed GRAS Rule and that based on FDA’s experience “streamlining [its]
evaluation of conclusions of GRAS status will enable [FDA] to evaluate more, and higher
priority, substances,” 81 Fed. Reg. at 54,961. Additionally, FDA considered countless
comments suggesting what Plaintiffs suggest here—that notifications should be mandatory—and
considered the GAO Report, which Plaintiffs rely on heavily in building their argument. See 81
Fed. Reg. at 54,960–55,028. For the aforementioned reasons, I do not find FDA’s actions to be
arbitrary and capricious.18
C.

FDCA Challenge

In a final attempt to strike down the GRAS Rule, Plaintiffs argue that the GRAS Rule is
unlawful because its criteria for determining GRAS status contradicts the FDCA. (Pls.’ Mot.
21–25.) In particular, Plaintiffs aver that the criteria within the GRAS Rule differs from the
FDCA’s requirement that a substance is eligible for GRAS status only if that substance is

18

It bears noting that Catskill Mountains distinguished between Chevron and State Farm based in part on whether
the agency’s interpretation of the statute was its first. See 846 F.3d at 521 (“State Farm review may be appropriate
in a case involving . . . a rule setting forth a changed interpretation of a statute.”). Although FDA has previously
interpreted the GRAS provision within the Food Additives Amendment, those prior interpretations, like the current
GRAS Rule, provided only for voluntary submissions. See 81 Fed. Reg. at 54,963–64 (describing the history of
FDA’s approach). Therefore, there was no change in FDA’s interpretation, which is the heart of Plaintiffs’
challenge here.

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“generally recognized, among experts qualified by scientific training and experience . . . as
having been adequately shown through scientific procedures . . . to be safe under the conditions
of its intended use.” 21 U.S.C. § 321(s); (Pls.’ Mot. 21.) Plaintiffs cite to five reasons: (1) the
GRAS Rule fails to include sufficient criteria to ensure that the data, information, and methods
upon which manufacturers base their GRAS determinations are “generally recognized”; (2) the
GRAS Rule does not include criteria to ensure that manufacturers’ GRAS determinations are
free from conflicts of interest; (3) the GRAS Rule does not contain any criteria to ensure
manufacturers do not self-certify substances as GRAS after FDA raises safety concerns about
them; (4) FDA finalized the GRAS Rule without including any criteria to prevent manufacturers
from secretly self-certifying newly synthesized or novel substances as GRAS; and (5) the GRAS
Rule fails to include criteria clarifying that carcinogenic substances can never be deemed safe for
use in food. (Pls.’ Mot. 21–25.)
At the outset, I note that reasons three and four are essentially reiterations of the issues
Plaintiffs flagged in their other challenges, and I do not restate my findings here. Regarding
Plaintiffs’ first reason, Plaintiffs make much of the fact that GRAS determinations can be based
on unpublished material. (Id. at 22.) Plaintiffs argue that because the information is
unpublished, it cannot be “generally recognized.” (Id.) However, as the Government points out,
general recognition is embodied within the GRAS Rule’s criteria. (See Govt. Mot. 21.) For
example, in general, GRAS determinations must be “based upon the application of generally
available and accepted scientific data, information, or methods,” 21 C.F.R. § 170.30(b), require
“common knowledge throughout the scientific community,” id. § 170.30(a), and require “the
same quantity and quality of scientific evidence as is required to obtain approval of a food
additive,” id. § 170.30(b). In responding to a comment, FDA explained “the common

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knowledge element of the GRAS standard precludes a GRAS conclusion if the data and
information . . . are only available in files that are not publicly accessible, such as in confidential
industry files.” 81 Fed. Reg. at 54,973. Although FDA itself notes the material used in making
GRAS determinations is “ordinarily . . . published,” 21 C.F.R. § 170.30(b); see 81 Fed. Reg. at
54,973, this is not inconsistent with its choice not to ban unpublished evidence from being
considered. Unpublished material is just one potential part of the GRAS determination.
Additionally, the use of unpublished material is not inconsistent with the FDCA. There is no
blanket prohibition on considering such material.19
Plaintiffs’ second concern about conflicts of interest does not render the GRAS Rule
inconsistent with the FDCA. Although Plaintiffs’ concern may be valid, in 2017, FDA issued
draft guidance on the issue, see Best Practices for Convening a GRAS Panel: Guidance for
Industry, U.S. Food and Drug Admin., https://www.fda.gov/media/109006/download, and the
FDCA is silent on what steps must be taken for addressing conflicts in GRAS determinations.
Plaintiffs cite to a study in the Record, showing that in “more than 450 GRAS determinations
voluntarily reported to FDA, every determination was made by experts with financial ties to the
manufacturer of the substance at issue.” (Pls.’ Mot. 23 (citing AR 008220).) This study reports
that of the 451 GRAS notices that were reviewed, “22.4% were made by an employee of an
additive manufacturer, 13.3% were made by an employee of a consulting firm selected by a
manufacturer, and 64.3% were made by an expert panel selected by the manufacturer or a firm

19

Plaintiffs argue that “[t]he conclusion that the GRAS Rule’s criteria fail to ensure true ‘general recognition’ is
confirmed by long-standing interpretations of that term, as it appears elsewhere in the FDCA. For example, the
Second Circuit has concluded that, in the absence of any ‘published scientific literature,’ qualified experts are likely
unable to make any determination as to the ‘general recognition’ of a drug product’s safety.” (Pls.’ Mot. 22 n.11
(quoting Premo Pharm. Labs., Inc. v. U.S., 629 F.2d 795, 804 (2d Cir. 1980).) Plaintiffs, however, fail to point me
to any provision within the FDCA that requires that general recognition be based on published material, and
Plaintiffs’ citation to a 40-year-old case involving a drug is inapposite.

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that was a consultant to the manufacturer.” (AR 008220.) The study, however, broadly uses the
term “financial interest” and noted that the interest of a selected expert panel would be the
interest in “[b]eing selected for more panels.” (Id. at 8219–20.) Additionally, inherent in the
GRAS Rule are certain safeguards, including that GRAS notices must have a signed statement
certifying that the notice is a “complete, representative, and balanced submission that includes
[known] unfavorable information.” 21 C.F.R. § 170.225(c)(9).
Finally, I consider Plaintiffs’ fifth reason: that the GRAS Rule is contrary to the Delaney
Clause, a provision within the FDCA that prohibits FDA from approving food additives that are
found to induce cancer. See 21 U.S.C. § 348(c)(3)(A). Plaintiffs state that FDA is aware that
certain manufactures have determined cancer-causing substances to be GRAS, and has not
articulated a position that “carcinogenic substances can never be deemed safe for use in food.”
(Pls.’ Mot. 24–25.) The Government notes that the Delaney Clause governs food additives, not
GRAS substances, and point to dicta from a D.C. Circuit case suggesting the Delaney Clause
may not bar a finding that a substance with de minimis carcinogenicity is GRAS. (Govt. Mot. 24
(citing Public Citizen v. Young, 831 F.2d 1108, 1119–20 (D.C. Cir. 1987)).) Plaintiffs respond
with a convoluted argument—“if a substance cannot be deemed ‘safe’ as a food additive, it
certainly cannot qualify to be generally recognized as safe.” (Pls.’ Opp. 25.)
Inherent in the GRAS Rule are criteria that would likely prevent a carcinogenic substance
from being deemed GRAS. See 21 C.F.R. § 170.30(a) (“General recognition of safety requires
common knowledge throughout the scientific community . . . that there is a reasonable certainty
that the substance is not harmful under the conditions of its intended use.”). Additionally, if the
Delaney Clause does in fact apply to GRAS determinations, then the criteria that Plaintiffs
contend is missing from the GRAS Rule, is already present. In conclusion, I find that the GRAS

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Rule does not unlawfully conflict with the FDCA.
Conclusion
Accordingly, because I find that the GRAS Rule (1) does not unlawfully subdelegate
FDA’s duty to ensure food safety; (2) does not exceed FDA’s statutory authority; (3) does not
constitute arbitrary and capricious agency action in violation of the FDCA and APA; and (4)
does not conflict with the FDCA, Plaintiffs’ motion for summary judgment is DENIED, and the
Government’s motion for summary judgment is GRANTED.
The Clerk of Court is respectfully directed to terminate docket entries 65 and 74, and to
close this case.
SO ORDERED.
Dated: September 30, 2021
New York, New York
______________________
Vernon S. Broderick
United States District Judge

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