Case 1:14-Cv-00267-RC Document 8 Filed 03/13/14 Page 1 of 24
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Case 1:14-cv-00267-RC Document 8 Filed 03/13/14 Page 1 of 24 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA ) CENTER FOR FOOD SAFETY, ) Case No. 1:14-cv-267-RC 660 Pennsylvania Avenue, SE, #302 ) Washington, District of Columbia 20003 ) ) Plaintiff, ) COMPLAINT FOR DECLARATORY ) AND INJUNCTIVE RELIEF v. ) ) Administrative Procedure Act Case KATHLEEN SEBELIUS, SECRETARY OF ) U.S. DEPARTMENT OF HEALTH AND ) HUMAN SERVICES, ) 200 Independence Avenue, SW ) Washington, District of Columbia 20201 ) ) and MARGARET A. HAMBURG, M.D., ) COMMISSIONER OF U.S. FOOD AND DRUG ) ADMINISTRATION, ) 5600 Fishers Lane ) Rockville, MD 20854 ) ) Defendants. ) ) ) ) Case 1:14-cv-00267-RC Document 8 Filed 03/13/14 Page 2 of 24 FIRST AMENDED COMPLAINT I. NATURE OF ACTION 1. This is an action for declaratory and injunctive relief challenging the United States Food and Drug Administration (FDA or the agency)’s unlawful action of exempting substances that are generally recognized as safe (GRAS) from regulation as food additives under a proposed rule for more than fifteen years. By indefinitely operating under a proposed rule in lieu of promulgating a final rule, FDA has deprived the public of the vital procedural rights afforded by the Administrative Procedure Act (APA). FDA’s implementation of the proposed rule without considering and responding to public comments, and its failure to promulgate a final GRAS rule, violates the rulemaking requirements of the APA. 2. FDA began operating under its proposed GRAS rule at the time the proposed rule was published. See Substances Generally Recognized as Safe, 62 Fed. Reg. 18938, 18954-18955 (proposed April 17, 1997). Now, more than fifteen years later, FDA is still operating under this proposed rule. 3. Not only does FDA’s action violate the APA’s rulemaking requirements, but it exempts substances from food additive regulations despite the fact that they may pose serious risks to human health and welfare. 4. Several substances or uses of substances allowed under the proposed rule that may pose serious risks to human health include, but are not limited to: Volatile Oil of Mustard, Olestra, and mycoprotein (known by the brand name “Quorn”). 5. Volatile Oil of Mustard and its chief component, allyl isothiocyanate (AITC), were introduced under the proposed rule in 2003 and 2005, respectively. AITC is used as a preservative either directly in food or incorporated into food packaging. Several scientific studies have found that AITC is a potential human carcinogen, including a two-year carcinogenesis bioassay in rats conducted by scientists at the National Institutes of Health. An evaluation of similar proposed uses of AITC by the European Food Safety Authority concluded that the uses would expose children to several-fold higher levels of AITC than is considered safe. 2 Case 1:14-cv-00267-RC Document 8 Filed 03/13/14 Page 3 of 24 6. Olestra was originally approved by FDA as a food additive in 1996 for limited use in savory snacks such as corn chips. Since then, two GRAS notifications submitted under the proposed rule in 2007 and 2010 have expanded the range of GRAS uses of Olestra to include a large array of ready-to-eat and ready-to-heat products, including baked goods, cheese, frostings and icings, mayonnaise, ice cream, frozen yogurt, breakfast bars, and chocolate. Olestra is an indigestible, man-made compound of sugar and fat with the sensory properties of fat, used to wholly or partially replace normal fat in low-fat or fat-free foods for the purpose of reducing caloric consumption. Over 18,000 people have submitted to FDA reports of adverse reactions they attribute to Olestra, including anal leakage, severe diarrhea, and other gastrointestinal complaints. Olestra also depletes the body of vitamins A, D, E, K, and a range of carotenoid compounds, such as lycopene, that are associated with reduced risk of heart disease and certain cancers. 7. Mycoprotein (known by its brand name “Quorn”) was introduced under the proposed rule in 2001. This additive is a fungus-based meat substitute that has been shown to cause hazardous allergic reactions that include vomiting, diarrhea, hives or broken blood vessels in the gastrointestinal tract or eyes, and life-threatening anaphylaxis. 8. As these products illustrate, FDA’s failure to comply with the APA has had serious consequences, exposing Plaintiff and the public to risky products without adequate procedural due process or meaningful agency oversight. This Court should declare that FDA has violated the APA by operating under a proposed rule that did not undergo the rulemaking procedures required by the APA. In addition, this Court should vacate the proposed rule and require FDA to apply the previous GRAS rule until and unless FDA properly promulgates a new GRAS rule in accordance with APA requirements. II. JURISDICTION 9. This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1331 (federal question) and 28 U.S.C. § 1346 (United States as defendant). 10. The relief requested is specifically authorized pursuant to 28 U.S.C. § 1651 3 Case 1:14-cv-00267-RC Document 8 Filed 03/13/14 Page 4 of 24 (writs) and 28 U.S.C. §§ 2201-02 (declaratory relief). An actual controversy exists between the parties within the meaning of 28 U.S.C. § 2201 (declaratory judgments). 11. Plaintiffs have a right to bring this action pursuant to the APA, 5 U.S.C. § 702. III. VENUE 12. Venue properly lies in this Court pursuant to 28 U.S.C. § 1391(e) because the Plaintiff resides in this District. IV. PARTIES 13. Plaintiff Center for Food Safety (CFS) is a nationwide nonprofit organization incorporated in the District of Columbia, with offices in the District of Columbia; San Francisco, California; and Portland, Oregon. Founded in 1997, CFS is dedicated to addressing the human health, environmental, economic, ethical, and social impacts associated with the development and commercialization of industrial agricultural and food processing technologies. 14. CFS has more than 400,000 members, including members in every state across the country, many of whom purchase and consume products containing potentially harmful substances that have been granted GRAS status unlawfully through FDA’s proposed rule. CFS and its members are being, and will be, adversely affected by FDA’s continued failure to respond to public comments and properly promulgate a final GRAS rule that adequately protects human health and safety. 15. CFS combines multiple tools and strategies in pursuing its goals, including public education, grassroots organizing, public and policymaker outreach, media outreach, campaigning, petitioning, submitting comments on agency rules, and when necessary, litigation. CFS has active campaigns dedicated to protecting food safety and preventing potentially harmful and untested substances from entering our food supply. 16. With regard to education, CFS disseminates to government agencies, members of Congress, and the general public a wide array of informational materials regarding new food substances and their actual and potential harms. 17. CFS and its members support thorough, comprehensive scientific review of any 4 Case 1:14-cv-00267-RC Document 8 Filed 03/13/14 Page 5 of 24 new and potentially dangerous substances introduced into our food supply. To that end, CFS and its members believe it is imperative that FDA promotes a responsible approach to the approval of substances as GRAS and require a thorough, independent review and analysis of all scientific evidence prior to granting GRAS status to any substance. 18. CFS also sends action alerts to its membership. These action alerts generate public involvement, education, and engagement with governmental officials on issues related to fighting the health and environmental impacts of industrial agriculture and promoting a more sustainable, healthier food system. Collectively, the dissemination of this material has made CFS an information clearinghouse for public involvement and governmental oversight of food safety issues. 19. Defendant Kathleen Sebelius is the Secretary of the United States Department of Health and Human Services, and is sued in her official capacity. 20. Defendant Dr. Margaret A. Hamburg is the Commissioner of FDA, and is sued in her official capacity. As Commissioner, Dr. Hamburg has the ultimate responsibility for FDA’s activities and policies. V. LEGAL BACKGROUND Administrative Procedure Act 21. Pursuant to the APA, “[g]eneral notice of proposed rulemaking shall be published in the Federal Register.” 5 U.S.C. § 553(b). In addition, agencies are required to give “interested persons an opportunity to participate in the rule making.” Id. § 553(c). “After consideration of the relevant matter presented, the agency shall incorporate in the rules adopted a concise general statement of their basis and purpose.” Id. 22. The APA defines a “rule” that is subject to its requirements as “the whole or part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy . and includes the approval or prescription for the future of . valuations, costs, or accounting, or practices bearing on any of the foregoing.” Id. § 551(4). 5 Case 1:14-cv-00267-RC Document 8 Filed 03/13/14 Page 6 of 24 23. The APA provides that “[a] person suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action . is entitled to judicial review thereof.” Id. § 702. 24. Courts shall “hold unlawful and set aside agency action . found to be . arbitrary, capricious, an abuse of discretion or otherwise not in accordance with the law,” or “without observance of procedure required by law.” Id. § 706(2)(A), (D). Food Additives Amendment of 1958 25. In 1958, Congress enacted the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act in response to public concern about the increased use of chemicals in foods and food processing.