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Case 3:16-cv-01574-VC Document 53 Filed 07/15/16 Page 1 of 67
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`ADAM KEATS (CSB No. 191157)
`GEORGE KIMBRELL (Pro Hac Vice)
`Center for Food Safety
`303 Sacramento Street, 2nd Floor, San Francisco, CA 94111
`T: (415) 826-2770 / F: (415) 826-0507
`Emails: akeats@centerforfoodsafety.org
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` gkimbrell@centerforfoodsafety.org
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`STEPHEN D. MASHUDA (Pro Hac Vice)
`Earthjustice
`705 Second Avenue, Suite 203, Seattle, WA 98104
`T: (206) 343-7340 / F: (206) 343-1526
`Email: smashuda@earthjustice.org
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`BRETTNY HARDY (Pro Hac Vice)
`Earthjustice
`50 California Street, Suite 500, San Francisco, CA 94111
`T: (415) 217-2142
`Email: bhardy@earthjustice.org
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`Counsel for Plaintiffs
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`
`INSTITUTE FOR FISHERIES RESOURCES;
`PACIFIC COAST FEDERATION OF
`FISHERMEN’S ASSOCIATIONS; GOLDEN
`GATE SALMON ASSOCIATION; KENNEBEC
`REBORN; FRIENDS OF MERRYMEETING BAY;
`CASCADIA WILDLANDS; CENTER FOR
`BIOLOGICAL DIVERSITY; ECOLOGY ACTION
`CENTRE; FRIENDS OF THE EARTH; FOOD
`AND WATER WATCH; THE QUINAULT
`INDIAN NATION; and CENTER FOR FOOD
`SAFETY,
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`Plaintiffs,
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`v.
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`SYLVIA MATHEWS BURWELL, Secretary of the
`United States Department of Health and Human
`Services; DR. ROBERT M. CALIFF, M.D.,
`Commissioner of the United States Food And Drug
`Administration; the UNITED STATES FOOD AND
`DRUG ADMINISTRATION; and the UNITED
`STATES FISH AND WILDLIFE SERVICE,
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`Defendants.
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`THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF CALIFORNIA
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`Case No. 3:16-cv-01574-VC
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`AMENDED COMPLAINT FOR
`DECLARATORY AND
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`CASE NO. 3:16-cv-01574-VC
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`Case 3:16-cv-01574-VC Document 53 Filed 07/15/16 Page 2 of 67
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`INTRODUCTION
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`1.
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`This case challenges the United States Food and Drug Administration’s approval
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`of a novel genetically engineered salmon for human consumption without considering or fully
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`disclosing the environmental and other risks of this unprecedented decision.
`2.
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`Plaintiffs Institute for Fisheries Resources, Pacific Coast Federation of
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`Fishermen’s Associations, Golden Gate Salmon Association, Kennebec Reborn, Friends of
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`Merrymeeting Bay, Cascadia Wildlands, Center for Biological Diversity, Ecology Action Centre,
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`Friends of the Earth, Food and Water Watch, the Quinault Indian Nation, and Center for Food
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`Safety (collectively Plaintiffs), on behalf of their adversely affected members, challenge
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`Defendants’ November 19, 2015, decision to approve an application by AquaBounty
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`Technologies, Inc. (AquaBounty) to develop, market, and sell for human consumption
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`genetically engineered (GE) salmon.
`3.
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`AquaBounty’s GE salmon (AquAdvantage salmon) is a novel, man-made animal:
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`an Atlantic salmon genetically engineered with genes from a deep water ocean eelpout and a
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`Pacific Chinook salmon in order to make it grow unnaturally fast.
`4.
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`The approval of GE salmon by the United States Food and Drug Administration;
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`Sylvia Mathews Burwell, Secretary of the United States Department of Health and Human
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`Services; and Dr. Robert M. Califf, Commissioner of the United States Food and Drug
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`Administration (collectively FDA or the agency) marks the first occasion in history where any
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`country has authorized the mass production of a GE animal of any variety to be sold as food.
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`Accordingly, this action will serve as a precedent for the assessment and regulation of all
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`potential future GE animals manufactured for human consumption, and for review of their
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`impacts on public health and the environment.
`5.
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`Pursuant to the FDA approval, AquaBounty will manufacture its GE salmon at a
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`facility located on Prince Edward Island, Canada, and then transport, by land and air, the
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`resulting eggs to a separate facility located in Panama, where the GE eggs will be grown to
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`maturity, before being processed and shipped back to the United States for sale. Those two
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`operational sites present substantial environmental risks, as discussed below.
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`6.
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`Importantly, this case concerns more than these two sites; it has much broader
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`implications. In order to gain FDA approval and downplay risks and concerns from the public,
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`AquaBounty sought to limit its application to just these two facilities; yet, since at least 2010, the
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`company has been engaged in efforts to expand the production of GE salmon to facilities around
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`the world, repeatedly telling its investors that it plans to raise GE salmon at other locations, in
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`both other foreign markets and the United States, beginning in 2016, and to sell the salmon in
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`other markets, including Canada, Argentina, Brazil, and China. In fact, AquaBounty has already
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`communicated its intent to import GE salmon eggs into the U.S. to be grown at other sites, and
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`has recently expanded its operations on Prince Edward Island. These expansions are a necessary
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`outgrowth of the AquaBounty business plan, since large-scale aquaculture is not economically
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`viable if it relies solely upon the highly convoluted, 5,000-mile multinational journey that
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`AquaBounty has initially proposed. This constitutes merely the company’s effort to open the
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`regulatory door. Yet, despite the company’s public statements, FDA approved the AquaBounty
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`application without disclosing or analyzing the significant environmental effects from this
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`foreseeable expansion.
`7.
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`The challenged decision is unlawful because FDA has not adequately assessed the
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`full range of potentially significant environmental and ecological effects presented by the
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`AquaBounty application, and/or significant changed circumstances since that application was
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`submitted, in violation of the Federal Food, Drug, and Cosmetics Act, 21 U.S.C. §§ 301-399(f)
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`(FFDCA); the National Environmental Policy Act, 42 U.S.C. §§ 4221-4370h (NEPA); the
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`Endangered Species Act, 16 U.S.C. §§ 1531-1544 (ESA); and the Administrative Procedure Act,
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`5 U.S.C. §§ 701-706 (APA). FDA has created a GE animal program that is a major federal
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`action, without preparing or engaging in a programmatic or other analysis of the impacts of that
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`program as required by NEPA. FDA also arbitrarily and capriciously denied the 2011 citizen
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`petition filed by several of the Plaintiffs by not preparing a full Environmental Impact Statement
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`(EIS) pursuant to NEPA on the foreseeable impacts of its decision.
`8.
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`Instead, FDA completed an extremely limited environmental assessment (EA) and
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`made a finding of no significant impact (FONSI) for the approval of AquaBounty’s GE salmon,
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`which together fail to discuss or adequately evaluate myriad scientific questions regarding the
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`risk of significant and irreversible environmental, ecological, and intertwined socioeconomic
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`harms related to the production, commercialization, and proliferation of AquaBounty’s GE fish.
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`These threats include: the risk that GE salmon will escape from the facilities where they are
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`manufactured or grown and interbreed with wild endangered salmon, compete with them for
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`food and space, or pass on infectious diseases; the interrelated impacts to salmon fisheries and
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`the social and economic well-being of those who depend on them; and the risks to ecosystems
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`from the introduction of an invasive species. Expert scientists, including those within other
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`federal agencies charged with the protection of fish and marine ecosystems, repeatedly cited
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`these risks and expressed great concern with FDA’s narrow, incomplete, unsubstantiated, and
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`outdated analysis of the potential environmental and ecological threats posed by GE salmon.
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`But, FDA ignored those concerns in its decisionmaking.
`9.
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`The inadequate EA, FONSI, and attendant decision not to prepare a
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`comprehensive EIS are the result of FDA’s failure to take the legally required “hard look” at
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`these direct, indirect, and cumulative impacts of the agency’s decision to allow mass production
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`of AquaBounty’s GE salmon, and are arbitrary, capricious, and contrary to NEPA. In addition,
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`the agency’s review was improperly segmented from AquaBounty’s broader plan; it failed to
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`adequately consider or assess numerous other reasonable alternatives to the proposed action;
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`FDA has not supplemented that analysis based on AquaBounty’s expanded Canadian facilities
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`and operations; and it improperly relied on AquaBounty’s proposed mitigation.
`10.
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`The challenged decision is also unlawful, in violation of the ESA, because FDA
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`failed to consult with the federal fish and wildlife agencies to insure that its approval of
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`AquaBounty’s application was not likely to jeopardize endangered and threatened species or
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`adversely modify critical habitat. The expert biologists at the wildlife and fisheries agencies, the
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`National Marine Fisheries Service and U.S. Fish & Wildlife Services (collectively Services),
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`urged FDA to engage in ESA consultation in association with its review of AquaBounty’s
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`application. These agencies’ scientists described the very real potential that approval of the
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`application may affect endangered Atlantic salmon populations. FDA’s determination that its
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`action would have “no effect” on any endangered or threatened species or critical habitat—and
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`consequently, its refusal to complete ESA consultation with the expert agencies—was based on
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`the faulty assumption that GE salmon could not escape from AquaBounty’s facilities, FDA’s
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`outdated risk analysis methods, and the agency’s unlawfully constricted view of the foreseeable
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`impacts of its approval decision.
`11.
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`Even apart from these vital considerations, FDA’s decision to approve
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`AquaBounty’s GE salmon application should be vacated and set aside because FDA lacks the
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`statutory authority to regulate GE animals as a “new animal drug” under the FFDCA. The
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`FFDCA does not explicitly grant FDA authority to regulate GE animals. Indeed, Congress never
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`intended or provided a means for FDA to regulate twenty-first century GE animals using its 1938
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`authority over veterinary animal drugs. To the contrary, GE animals present enormously
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`different risks and impacts than drugs, requiring different expertise, analyses, and regulation than
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`were contemplated when Congress enacted the FFDCA. Nevertheless, FDA issued Guidance for
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`Industry 187, The Regulation of Genetically Engineered Animals Containing Heritable
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`Recombinant DNA Constructs (GE Animal Guidance or the Guidance), interpreting the
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`definition of “new animal drug” under the FFDCA to include GE animals, asserting exclusive
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`authority over GE animals under the new animal drug provisions of the FFDCA, and purportedly
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`outlining the steps that FDA will follow when considering applications for GE animals. FDA’s
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`approval of AquaBounty’s application and the issuance of its GE Animal Guidance represent an
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`unlawful effort to extend FDA’s regulatory reach far beyond the statutory mandates of the
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`FFDCA. FDA’s assertion of jurisdiction under the GE Animal Guidance and its approval of the
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`AquaBounty application are thus ultra vires and contrary to law in violation of the APA and the
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`FFDCA.
`12.
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`Finally, even if FDA had the authority to issue the GE Animal Guidance, the
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`guidance itself fails to explain how FDA will substantively incorporate important environmental
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`considerations into its assessment of safety and effectiveness as a part of the review and approval
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`of GE animals. As a practical result of the inadequacies of the GE Animal Guidance, FDA failed
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`to adequately consider environmental risks as part of its statutory “safety” evaluation when
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`reviewing and approving AquaBounty’s GE salmon application in this case.
`13.
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`Accordingly, Plaintiffs ask this Court to: (1) declare that FDA’s decision to
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`approve the AquaBounty application for GE salmon is arbitrary, capricious, and in violation of
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`the APA, NEPA, and the ESA; (2) declare that the FDA GE Animal Guidance is unlawful under
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`the APA and the FFDCA, that FDA has no jurisdiction to regulate GE animals under the new
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`animal drug provisions of the FFDCA, and that FDA’s approval of AquaBounty’s application is
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`ultra vires and contrary to law under the APA and the FFDCA; (3) vacate FDA’s November 19,
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`2015 approval decision; and (4) enjoin FDA to withdraw its assertion of jurisdiction over GE
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`animals and enjoin FDA from taking further action on AquaBounty’s GE salmon application or
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`any other application for commercialization of a genetically engineered food animal until
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`Congress provides explicit statutory authority governing regulation of such products and vests
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`clear authority for such regulation in a named agency of the Executive Branch of the United
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`States.
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`JURISDICTION AND VENUE
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`14.
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`This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1331 (federal
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`question), 28 U.S.C. § 1346 (United States as a defendant), 28 U.S.C. §§ 2201-02 (declaratory
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`and injunctive relief) and 5 U.S.C. §§ 701-706 (APA). An actual controversy exists between the
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`parties within the meaning of 28 U.S.C. § 2201.
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`15.
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`The Court has jurisdiction to review FDA’s failure to consult with the Services
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`under the citizen-suit provision of the ESA, 16 U.S.C. § 1540 (g)(1), which provides that the
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`“district courts shall have jurisdiction … to enforce any such provision or regulation” of the
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`ESA. As required by the ESA, Plaintiffs provided sixty days’ notice of their intent to sue by
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`letter sent to FDA and the Services on December 22, 2015 and January 25, 2016. Copies of
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`those letters are appended as Exhibit 1. FDA has not remedied the violations set out in those
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`sixty-day notices. See 16 U.S.C. § 1540(g)(2)(A).
`16.
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`Venue is properly vested in this judicial district under 28 U.S.C. § 1391 (e)(1)(C)
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`because no real property is involved in this action, several of the Plaintiffs reside in and/or
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`maintain places of business in this district, and members of the Plaintiff organizations reside in
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`this district.
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`Plaintiffs
`17.
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`PARTIES
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`Plaintiff Institute for Fisheries Resources (IFR) is a nonprofit public interest
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`marine resources protection and conservation organization. IFR’s members, most of whom are
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`commercial salmon fishermen or women, have personal interests in the restoration of salmon
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`fisheries.
`18.
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`Plaintiff Pacific Coast Federation of Fishermen’s Associations (PCFFA) is a
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`nonprofit membership organization composed of trade associations of commercial fisherman on
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`the west coast, from San Diego to Alaska. PCFFA is separate from, but closely related to, IFR.
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`PCFFA is incorporated in and headquartered in California. For over thirty years, PCFFA has
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`advocated to ensure the rights of individual fishermen and to fight for the long-term survival of
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`commercial fishing as a livelihood and way of life. PCFFA’s port and member associations and
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`at-large members represent nearly 1,200 commercial fishing families who are small and
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`mid-sized commercial fishing boat owners and operators, most of whom derive all or a portion of
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`their income from the harvesting of Pacific salmon.
`19.
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`Plaintiff Golden Gate Salmon Association (GGSA) is a coalition of salmon
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`advocates, including commercial and recreational fishermen, businesses, restaurants, tribes,
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`environmentalists, and communities that rely on salmon, from Oregon to the Central Coast,
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`through the Bay-Delta and into the Central Valley. GGSA seeks to protect and restore
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`California’s largest salmon producing habitat in the Central Valley for the benefit of the
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`Bay-Delta ecosystem and the diverse communities that rely on salmon as a long-term,
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`sustainable commercial, recreational and cultural resource.
`20.
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`Plaintiff Center for Food Safety (CFS) is a public interest, nonprofit
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`organization whose mission is to empower people, support farmers, and protect the earth from
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`the adverse impacts of industrial food production. CFS has more than 750,000 members across
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`the country and offices in San Francisco, California; Portland, Oregon; Washington, D.C.; and
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`Honolulu, Hawaii. CFS is a recognized national leader on the issue of genetically engineered
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`crops and other GE organisms, and has worked to improve their regulation and address their
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`impacts continuously since the organization’s inception in 1997.
`21.
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`Plaintiff Friends of the Earth, U.S. (FoE) is a national, nonprofit environmental
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`advocacy organization founded in 1969 and incorporated in the District of Columbia, with its
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`headquarters in Washington, D.C. and an office in Berkeley, California. FoE’s mission is to
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`defend the environment and champion a healthy and just world. To this end, FoE promotes
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`policies and actions that address the climate change crisis, minimize the negative impacts of
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`environmental pollution, keep toxic and risky technologies out of the food we eat and products
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`we use, and protect marine ecosystems and the people who live and work near them. FoE has
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`more than 175,000 members in all fifty states.
`22.
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`Plaintiff Center for Biological Diversity (the Center) is a nonprofit incorporated
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`in California and headquartered in Tucson, Arizona, with field offices throughout the United
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`States, including Arizona, New Mexico, California, Nevada, Oregon, Washington, Alaska,
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`Minnesota, Vermont, Florida, and Washington, D.C. The Center uses science, law, and media to
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`secure a future for all species, great or small, hovering on the brink of extinction.
`23.
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`Plaintiff Food and Water Watch (FWW) is a national, nonprofit consumer
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`advocacy organization with its headquarters in Washington, D.C. and several offices throughout
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`the United States, including in Oakland, California. FWW works to ensure safe food and clean
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`water, advocating for safe, wholesome food produced in a humane and sustainable manner, and
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`public, rather than private control of water resources, including oceans, rivers, and groundwater.
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`For more than five years, FWW has advocated for stronger regulation and labeling of genetically
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`engineered organisms, including salmon. FWW has approximately 76,000 members and
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`900,000 supporters in the United States.
`24.
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`Plaintiff Ecology Action Centre (EAC), established in 1971, is Nova Scotia’s
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`largest and oldest environmental organization, serving Nova Scotia in a variety of capacities for
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`over forty years. EAC has over 3,000 members who reside predominantly in Nova Scotia, with
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`some members residing in the other Atlantic provinces, the rest of Canada and internationally.
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`Drawing on current science and public policy, staff and members of the organization work to
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`protect and conserve terrestrial and aquatic ecosystems in Nova Scotia and Atlantic Canada.
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`EAC has played a pivotal role in protecting important ecological areas in Nova Scotia including
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`some of the remaining Atlantic salmon rivers and their surrounding habitat. EAC has a strong
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`track record when it comes to marine conservation, with staff participating in a range of
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`provincial, national and international processes and fora to advance sustainable fishing practices
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`and the protection of endangered or threatened species such as Atlantic salmon. In early 2014
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`EAC, along with Living Oceans Society, challenged the Canadian government’s decision to
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`allow AquaBounty Canada Inc. to manufacture and export genetically modified salmon eggs.
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`EAC considers genetically modified salmon and genetic contamination a serious threat to
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`Atlantic salmon in Nova Scotia and throughout its range.
`25.
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`Plaintiff Cascadia Wildlands (Cascadia) is a nonprofit organization incorporated
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`in Oregon, with a field office in Cordova, Alaska, that focuses on conservation of the wildlife
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`and communities of the Cascadia bioregion (i.e., the Pacific coastal temperate rainforest,
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`stretching from northern California to southeast Alaska). Cascadia has approximately 5,000
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`members throughout the United States, including subsistence, commercial, and recreational
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`fishermen; and, processors, marketers, and consumers of salmon. Cascadia educates, agitates,
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`and inspires a movement to protect and restore Cascadia’s wild ecosystems, including healthy
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`wild salmon populations. Salmon are widely acknowledged as a keystone species in the
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`bioregion, and so Cascadia members, like most residents, have a special relationship with
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`salmon.
`26.
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`Plaintiff Kennebec Reborn is a 501(c)(3) Maine nonprofit conservation
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`organization founded in 2011 to advocate and promote the restoration of Atlantic salmon and
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`other native sea-run fish to their historic habitat in the rivers of New England. Kennebec Reborn
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`and its board members work closely with allied national, regional, and local conservation groups
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`at various levels of formality to bring native sea-run fish back to their homes by advocating for
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`fish passage and improved habitat conditions within the Kennebec and Maine’s other coastal
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`watersheds. Kennebec Reborn members have been involved as plaintiffs and citizen intervenors
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`CASE NO. 3:16-cv-01574-VC
`AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF
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`Case 3:16-cv-01574-VC Document 53 Filed 07/15/16 Page 10 of 67
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`since 1996 in successful litigation to protect native Atlantic salmon in Maine under the ESA,
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`including litigation to expand ESA protections to Atlantic salmon in the Kennebec,
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`Androscoggin, and Penobscot Rivers. Kennebec Reborn also is the caretaker of the Atlantic
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`Salmon History Project, an online archive of historic documents and records that describe the
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`former abundance of sea-run fish in New England rivers and their progressive diminution since
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`the late 1700s.
`27.
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`Plaintiff Friends of Merrymeeting Bay is a nonprofit organization, incorporated
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`in Maine, dedicated to preserving the ecological, aesthetic, biological, and commercial values of
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`Merrymeeting Bay, its watershed, and the Gulf of Maine (the part of the Northwest Atlantic
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`Ocean where Merrymeeting Bay is located). Friends of Merrymeeting Bay and its members
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`work to protect these waters and their fish and wildlife through research, advocacy, education,
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`and land conservation. Friends of Merrymeeting Bay and its members are dedicated to the
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`protection of the last remaining Atlantic salmon populations in Maine and were instrumental in
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`the fight to secure the ESA listing for Atlantic salmon in the Kennebec, Androscoggin, and
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`Penobscot Rivers.
`28.
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`Plaintiff Quinault Indian Nation is a federally-recognized Indian tribe and
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`sovereign nation consisting of the Quinault and Queets tribes and descendants of five other
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`coastal tribes: Quileute, Hoh, Chehalis, Chinook, and Cowlitz. The Quinault Reservation is
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`located in the southwestern corner of the Olympic Peninsula in Washington State and is
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`comprised of magnificent forests, swift-flowing rivers, gleaming lakes, and twenty-three miles of
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`unspoiled Pacific coastline. The Quinault have been called the Canoe People because of the
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`primacy of the ocean, bays, estuaries, and rivers to every aspect of tribal life. The Quinault
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`Indian Nation is a signatory to the Treaty of Olympia (1856) in which it reserved a right to take
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`fish at its “usual and accustomed fishing grounds and stations” and the privilege of hunting and
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`gathering, among other rights, in exchange for ceding lands it historically roamed
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`freely. Treaties create a special fiduciary duty and trust responsibility upon all agencies of the
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`United States and states to protect treaty rights, including fishing rights. Seminole Nation v.
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`United States, 316 U.S. 286, 297 (1942). These rights cannot be abrogated except by explicit
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`CASE NO. 3:16-cv-01574-VC
`AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF
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`Case 3:16-cv-01574-VC Document 53 Filed 07/15/16 Page 11 of 67
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`Congressional authorization. In the landmark “Boldt decision,” a federal court confirmed that
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`Indian tribes, including the Quinault Nation, have a right to half of the harvestable fish in state
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`waters and established the tribes as co-managers of the fisheries resource with the State of
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`Washington. The Boldt decision also confirmed the Quinault Nation’s usual and accustomed
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`fishing areas include Reservation waters, Grays Harbor and the streams emptying into it, and the
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`Pacific Ocean adjacent to its territory. United States v. Washington, 384 F. Supp. 312, 374-375
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`(W.D. Wash. 1974). The Quinault Indian Nation has an obvious and keen interest in protecting
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`the fish and fish habitat that it relies on to exercise its federally-guaranteed treaty fishing rights,
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`as well as the traditional areas used for gathering plants for traditional cultural use. FDA’s
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`approval of GE salmon for commercial production and human consumption without adequate
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`consideration for the environmental consequences of that approval threatens these interests and
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`harms the Quinault’s commercial, recreational, aesthetic, spiritual, and other interests.
`29. Members of the Plaintiff organizations and the Quinault Indian Nation use and
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`enjoy salmon and salmon habitats on both the east and west coasts of the United States and
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`Canada for recreational, scientific, aesthetic, cultural, spiritual, subsistence, and commercial
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`purposes. Plaintiffs’ members observe and interact with Atlantic and Pacific salmon and their
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`marine and freshwater habitats through wildlife observation, study and photography, and
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`recreational, commercial, and subsistence fishing. These activities require viable populations of
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`wild Atlantic and Pacific salmon that contribute to healthy, functioning ecosystems. The identity
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`and genetic integrity of wild salmon runs, populations, and fisheries is itself an asset that is used
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`and valued by Plaintiffs’ members. Plaintiffs and their members derive or, but for the threatened
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`and endangered status of many Atlantic and Pacific salmon species, would derive recreational,
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`scientific, aesthetic, cultural, spiritual, and commercial benefits from the existence of these
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`species in the wild.
`30.
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`FDA’s approval of the AquaBounty GE salmon harms Plaintiffs and their
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`members’ past, present, and future enjoyment of salmonids and salmonid habitat by allowing
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`production of GE salmon to proceed without adequate regulation and analyses of associated, and
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`potentially irreversible, environmental and ecological impacts. These aesthetic, cultural,
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`CASE NO. 3:16-cv-01574-VC
`AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF
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`Case 3:16-cv-01574-VC Document 53 Filed 07/15/16 Page 12 of 67
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`spiritual, conservation, recreational, commercial, subsistence, scientific, and procedural interests
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`of Plaintiffs and their respective members have been, are being, and, unless the relief prayed for
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`herein is granted, will continue to be adversely affected and irreparably injured by FDA’s failure
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`to comply with NEPA, the APA, the ESA, and the FFDCA, as described below. Plaintiffs have
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`no adequate remedy at law.
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`Defendants
`31.
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`Defendant Sylvia Mathews Burwell is the Secretary of the United States
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`Department of Health and Human Services, which includes the United States Food and Drug
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`Administration. The Secretary of the U.S. Department of Health and Human Services, “through
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`the Commissioner” of FDA, regulates new animal drugs. 21 U.S.C. § 393(d)(2). Secretary
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`Burwell is named a defendant solely in her official capacity.
`32.
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`Defendant Dr. Robert M. Califf, M.D. is the Commissioner of the U.S. Food and
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`Drug Administration. In that capacity, he is directly responsible for overseeing the FDA review
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`process for the AquaBounty application and is tasked with the authority to approve or deny
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`AquaBounty’s application upon a finding that applicable legal requirements have or have not
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`been met. Commissioner Califf is named as a defendant solely in his official capacity.
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`Commissioner Califf is responsible for the approval of AquaBounty’s application on November
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`19, 2015, through Bernadette M. Dunham, D.V.M., Ph.D., Director, Center for Veterinary
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`Medicine, who formally signed the agency’s approval letter.
`33.
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`Defendant United States Food and Drug Administration is a federal agency within
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`the U.S. Department of Health and Human Services. FDA is charged with the regulation of
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`medical products, tobacco, foods, and veterinary medicine. As described by the agency itself,
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`FDA is responsible for protecting public health by assuring that foods (except for meat from
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`livestock, poultry, and some egg products which are regulated by the U.S. Department of
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`Agriculture) are safe, wholesome, sanitary, and properly labeled; ensuring that human and
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`veterinary drugs, vaccines and other biological products, and medical devices intended for
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`human use are safe and effective; protecting the public from electronic product radiation;
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`assuring cosmetics and dietary supplements are safe and properly labeled; regulating tobacco
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`CASE NO. 3:16-cv-01574-VC
`AMENDED COMPLAINT FOR DECLARATORY & INJUNCTIVE RELIEF
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`11
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`Case 3:16-cv-01574-VC Document 53 Filed 07/15/16 Page 13 of 67
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`products; and advancing the public health by helping to speed product innovations. FDA’s
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`November 19, 2015, approval of the AquaBounty new animal drug application is the only
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`existing federal agency approval of AquaBounty’s GE salmon.
`34.
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`Defendant United States Fish and Wildlife Service (FWS) is a federal agency
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`within the Department of the Interior authorized and required by law to protect and manage fish,
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`wildlife, and native plant resources of the United States, including enforcing the ESA. FWS has
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`been delegated authority by the Secretary of the Interior to implement the ESA for many
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`endangered fish species, including shared responsibility for making decisions and promulgating
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`regulations for endangered Atlantic salmon.
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`STATUTORY AND REGULATORY BACKGROUND
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`I.
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`Federal Food Drug and Cosmetic Act
`35.
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`In enacting the FFDCA in 1938, Congress provided FDA the authority and
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`obligation to protect public health and safety by overseeing ce

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