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Center for Food Safety v. Burwell

United States District Court, D. Columbia.

September 4, 2015

SYLVIA BURWELL, in her official capacity as Secretary of U.S. Department of Health and Human Services, et al., Defendants

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          For CENTER FOR FOOD SAFETY, Plaintiff: Peter T. Jenkins, LEAD ATTORNEY, Center for Food Safety, Washington, DC; Cristina R. Stella, Paige M. Tomaselli, PRO HAC VICE, CENTER FOR FOOD SAFETY, San Francisco, CA.

         For SYLVIA M. BURWELL, Secretary of Health and Human Services, STEPHEN OSTROFF, M.D., Acting Commissioner of Food and Drugs, Defendants: Kerala Thie Cowart, LEAD ATTORNEY, U.S. DEPARTMENT OF JUSTICE, Civil Division, Consumer Protection Branch, Washington, DC.

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          Re Document No.: 17


         RUDOLPH CONTRERAS, United States District Judge.

         Denying Plaintiff'S Motion for Attorneys' Fees and Costs


         In this action, the Center for Food Safety (" CFS" ) seeks from the U.S. Food and Drug Administration (" FDA" ), the Secretary of Health and Human Services, and the Commissioner of Food and Drugs (collectively, the " Defendants" ) an award of attorneys' fees and costs incurred in litigating its claims under the Administrative Procedure Act (" APA" ), see 5 U.S.C. § § 500 et seq. CFS contends that, pursuant to the Equal Access to Justice Act, 28 U.S.C. § 2412(d)(1)(A), it is entitled to reasonable attorneys' fees and costs because it was the " prevailing party" in the litigation and because the Defendants' position was not " substantially justified." The Defendants dispute both contentions. Because the Court concludes that the Defendants' position was substantially justified, the Court denies CFS's motion for attorneys' fees and costs.


         In 1958, Congress enacted the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act, see 21 U.S.C. § § 301 et seq. (" FFDCA" ), requiring food manufacturers to submit to FDA evidence demonstrating the safety of food additives before FDA approves the additives for use in the marketplace. See generally Substances Generally Recognized as Safe, 62 Fed.Reg. 18,938, 18,938-39 (proposed Apr. 17, 1997) (to be codified at 21 C.F.R. § 170.36). Under this amendment, " food additive" is defined to exclude substances " generally recognized . . . to be safe under the conditions of [their] intended use," which are often referred to as " GRAS" substances. 21 U.S.C. § 321(s) (2009). Accordingly, if food manufacturers determine independently that their substances are GRAS for a particular use, they are permitted to bring these substances to the marketplace without FDA's approval and without even notifying FDA. See 62 Fed.Reg. at 18,939; Am. Compl. 7; Mem. Supp. Defs.' Mot. Dismiss 12. In the late

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1960s, however, after new scientific information came to light that cast doubt on a substance that FDA had previously considered GRAS for its intended use, FDA promulgated regulations establishing a " petition affirmation process" by which food manufacturers could voluntarily petition FDA for " official recognition" of their substance's GRAS status. See 21 C.F.R. § 170.30-35; U.S. Gov't Accountability Office, GAO-10-246, Food Safety: FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS) 5 (2010) [hereinafter " GAO Report" ]; Am. Compl. 7; Mem. Supp. Defs.' Mot. Dismiss 7. As part of this voluntary process, food manufacturers would submit scientific data as part of their initial petition. See 21 C.F.R. § 170.35 (2011). FDA would then proceed by comprehensively reviewing this scientific data, publishing a notice in the Federal Register for comment, and drafting an explanation of FDA's GRAS determination. GAO Report at 5-6; Am. Compl. 8; Mem. Supp. Defs.' Mot. Dismiss 8.

         In 1997, claiming that the previous GRAS " petition affirmation process" was too cumbersome for both food manufacturers and the agency, FDA issued a proposed rule (the " Proposed Rule" ) changing this voluntary procedure to permit food companies to merely " notify" FDA of their GRAS determinations. See 62 Fed.Reg. at 18,938-41. Under the Proposed Rule, FDA no longer conducts a comprehensive scientific investigation of submitted data or " affirms" the GRAS status of a substance. GAO Report at 6; Am. Compl. 9; Mem. Supp. Defs.' Mot. Dismiss 9. Instead, once FDA reviews a company's GRAS notice, it sends the company a letter with one of three notifications: 1) FDA has " no questions" about the company's independent GRAS determination; 2) the company's GRAS notice does not provide a sufficient basis for a GRAS determination; or 3) FDA has ceased to evaluate the GRAS notice at the company's request. GAO Report at 6. FDA stresses that these letters are nonbinding and do not constitute a legal or factual determination that a substance is or is not GRAS. See Defs.' Resp. to Pl.'s Mot. Att'y Fees 2, ECF No. 18.

         In the Proposed Rule, FDA also announced an interim policy (the " Interim Policy" ) permitting food manufacturers to submit GRAS notices under the process described in the Proposed Rule until FDA finalizes any rule based on the proposal. See 62 Fed.Reg. at 18,954-55. Since 1997, FDA has operated under the Interim Policy, though FDA has sought comments during two different time periods. See id. at 18,954; Substances Generally Recognized as Safe, 75 Fed.Reg. 81,536, 81,536 (Dec. 28, 2010). FDA has neither responded to any of the comments nor issued a final rule. See Am. Compl. 2; Mem. Supp. Defs.' Mot. Dismiss 11-12.

         In February 2014, CFS brought this action against the Defendants. See generally Compl. The amended complaint alleged that FDA's failure to adopt a final rule or respond to commenters after seventeen years " deprive[s] the public of the vital procedural rights afforded by the [APA]." [1] Am. Compl. 2. Because of the long delay in finalizing the Proposed Rule and because FDA currently operates under the Interim Policy, CFS argued that the Proposed Rule " constitutes final agency action within the meaning" of 5 U.S.C. § 704, and is thus subject to judicial review.

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Am. Compl. 22. After finding that FDA's action meets this threshold test, the Court, CFS argued, should " hold unlawful and set aside" the Proposed Rule under § 706(2)(A) as " arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law," or, in the alternative, under § 706(2)(D) as " without observance of procedure required by law." Id.; see also 5 U.S.C. § 553(c) (requiring agencies to " give interested parties an opportunity to participate" in rulemaking). Accordingly, in its prayer for relief, CFS requested that the Court vacate the Proposed Rule and declare that the Defendants had violated and continue to violate the APA " by failing to respond to comments and properly promulgate a final GRAS rule." Am. Compl. 23.

         In response, the Defendants filed a motion to dismiss, arguing that CFS lacked standing to sue, that the Proposed Rule and the Interim Policy are not final agency action and are thus not subject to judicial review, and that CFS's challenge was barred by the statute of limitations. See generally Mem. Supp. Defs.' Mot. Dismiss. The parties later agreed, however, that resolution of this matter without further litigation was in their best interest. See Consent Decree, ECF No. 15. Upon agreement between CFS and the Defendants, the Court issued a Consent Decree on October 20, 2014, requiring FDA to finalize the Proposed Rule and submit the final rule to the Federal Register for publication no later than August 31, 2016. Id. at 2. The Court may grant FDA an extension of this deadline only if 1) the Court obtains the written consent of both CFS and FDA, or 2) FDA files a motion that the Court finds successfully demonstrates " good cause and/or exceptional circumstances warranting the extension." Id. at 2-3. In that same Consent Decree, CFS agreed to release all of its claims in the case. Id. at 5.

         Now before the Court is CFS's motion for attorneys' fees and costs under the Equal Access to Justice Act. See Pl.'s Mot. Att'y Fees, ECF No. 17. The motion is now fully briefed and ripe for decision.

         III. ...

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