Ctr. for Food Safety v. Becerra
| Citation | 565 F.Supp.3d 519 |
| Decision Date | 30 September 2021 |
| Docket Number | 17-CV-3833 (VSB) |
| Parties | CENTER FOR FOOD SAFETY, Breast Cancer Prevention Partners, Center for Science in the Public Interest, Environmental Defense Fund, and Environmental Working Group, Plaintiffs, v. 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. |
| Court | U.S. District Court — Southern District of New York |
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.
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.
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 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, 104 S.Ct. 2778, 81 L.Ed.2d 694 (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, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983), and that it does not conflict with the FDCA, the Government's motion for summary judgment is GRANTED. Plaintiffs’ motion is DENIED.
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 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.
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.
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 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.
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...
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