Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Institute for Fisheries Resources v. Hahn

United States District Court, N.D. California

December 19, 2019

STEPHEN HAHN, et al., Defendants.



         The Food and Drug Administration has concluded that its authority to regulate drugs includes the authority to regulate the material used to modify an animal's genetic makeup. Pursuant to that asserted authority, the FDA approved a company's application to create, through genetic manipulation, a type of salmon that grows to mature size more quickly than normal. As a condition of approval, the FDA imposed restrictions on how and where the salmon are grown, to reduce the risk that the engineered salmon will mix with normal salmon.

         The FDA's approval of the salmon has drawn a lawsuit by a coalition of environmental and industry groups. The lawsuit is both a broadside attack on the FDA's authority to regulate the genetic engineering of animals and a targeted attack on the particular process by which the agency approved the salmon. Presently, the Court has been asked to address the broadside attack. For the most part, the parties have left for a later date the adjudication of specific claims relating to the salmon approval.

         The plaintiffs' broadside attack has a head-scratching element to it. Although they insist the FDA lacks the authority to regulate the genetic engineering of animals, the plaintiffs have not explained how this conduct can otherwise be regulated under current law. It thus appears that their argument, if successful, would create a regulatory void in which companies would be free to genetically engineer animals without meaningful regulatory oversight (at least unless Congress were able to agree on legislation restricting genetic engineering of animals). But even without considering these consequences, the FDA's assertion of authority is valid. Under the plain language of the Food, Drug, and Cosmetic Act, the FDA has the authority to require companies to seek its approval before creating and breeding genetically engineered animals. Perhaps the genetic material used to modify an animal does not seem like a “drug” in the colloquial sense, but it is the statutory definition that matters. The statutory definition of “drug” is far broader than the ordinary meaning of that word, and the modification of an animal's genetic makeup falls squarely within the statutory definition.

         Because the FDA possesses the authority to regulate this conduct, and for the additional reasons set forth in this ruling, the government largely prevails in this round of the litigation. A hearing will take place in May 2020 on the second round, which involves the question whether the agency's approval of the genetically engineered salmon was faulty, even if its general assertion of jurisdiction over genetic engineering is lawful.


         To genetically engineer an animal, a scientist first derives a sequence of recombinant DNA, known in this field as an rDNA construct. This construct can encode and represent a specific trait. Next, the rDNA construct is integrated into the genome of an animal. In essence, the presence of the construct will cause the animal to express the sought-after trait. And the rDNA construct can be heritable, meaning that the animal will pass the trait to its progeny. Take the following real-world example: If a scientist wants to engineer a fish that glows under certain kinds of light, they would first derive an rDNA construct that represents the trait of glowing under those kinds of light, and then they would integrate the construct into the genome of a fish. Now the scientist has a glowing fish, as well as the ability to breed a whole line of glowing fish.

         The FDA regulates certain rDNA constructs on the theory that they are “drugs” under the Food, Drug, and Cosmetic Act (FDCA). The FDA first signed off on the use of an rDNA construct to genetically engineer an animal in 2009. That construct, when integrated into a goat's genome, causes the goat to produce an anticoagulant in its milk, which in turn is used to produce a medication that prevents certain people from getting blood clots. 21 C.F.R. § 528.1070. The FDA next approved an application for an rDNA construct intended to produce chickens whose egg whites contain a protein that treats a rare enzyme disorder. § 528.2010. And just this year, the FDA greenlit an rDNA construct that causes rabbits to produce milk capable of treating hemophilia. § 528.1080. The FDA has also declined, in an exercise of its enforcement discretion, to regulate the genetic engineering of some animals, including the glow fish mentioned above. See International Center for Technology Assessment v. Thompson, 421 F.Supp.2d 1, 5 (D.D.C. 2006).

         AquaBounty Technologies, Inc. employed a similar technique to create salmon with an abnormally high growth rate. To create its rDNA construct, AquaBounty derived genetic material from a Pacific Chinook salmon and from an ocean pout (which is another type of fish). AquaBounty integrated that rDNA construct into the genome of an Atlantic salmon to produce a line of fish that apparently grow to full size in roughly half the standard time. The commercial moniker for AquaBounty's genetically engineered fish is the AquAdvantage salmon.

         In November 2015, the FDA granted AquaBounty's application for approval of this rDNA construct as a new animal drug. In technical terms, the FDA approved the use of “[a] single copy of the α-form of the opAFP-GHc2 recombinant deoxyribonucleic acid (rDNA) construct at the α-locus in the EO-1 α lineage of triploid, hemizygous, all-female Atlantic salmon (Salmo salar).” 21 C.F.R. § 528.1092(a). The regulation memorializing the FDA's approval limits the production of these fish to “physically-contained, freshwater culture facilities specified in an FDA-approved application.” § 528.1092(d).

         From a regulatory standpoint, the AquAdvantage salmon present somewhat different issues from the goats, chickens, and rabbits mentioned above. Those other animals are engineered to produce something that becomes an ingredient in a drug to be taken by human beings. The FDA's drug authority is exercised at the front end (when the rDNA construct is used on the animal) and the back end (when the animal's byproduct is turned into a drug for people). The salmon, on the other hand, merely become food to be consumed by people. AquaBounty's application represents the FDA's first approval of the use of an rDNA construct to develop genetically engineered animals destined for the kitchen table.

         In its initial approval, the FDA mandated a production process whereby AquaBounty produced eggs in Canada on Prince Edward Island and grew the eggs into mature fish inside freshwater tanks in Panama. Application AR 23116. The FDA also imposed various conditions of use (including agency inspections) to ensure that the AquAdvantage salmon are sterile and cannot escape into the wild. Application AR 23117-19. At present, with the FDA's permission, AquaBounty is raising the salmon in landlocked, freshwater tanks in Indiana. See Statement of FDA Commissioner Scott Gottlieb, Continued Efforts to Advance Safe Biotechnology Innovations, and the Deactivation of an Import Alert on Genetically Engineered Salmon (Apr. 8, 2019), The Department of Agriculture recently finalized labeling standards for the AquAdvantage salmon that carry an implementation date of January 1, 2020. National Bioengineered Food Disclosure Standard, 83 Fed. Reg. 65, 814 (Dec. 21, 2018); see 7 C.F.R. §§ 66.6, 66.13. The first harvest of AquAdvantage salmon is planned for late 2020, so filets of these genetically engineered salmon could be sold for consumption in the United States not long after.

         A coalition of environmental and industry groups, believing the FDA's approval of AquAdvantage salmon to be unlawful, brought this lawsuit against the FDA and its Commissioner, as well as the Secretary of Health and Human Services and the Fish and Wildlife Service.[1] At a ten-thousand-foot level, the plaintiffs contend that: (i) the FDA lacks the authority to regulate rDNA constructs as drugs; and (ii) the agency has not adequately evaluated the environmental risks posed by genetically engineered animals in general, or by the AquAdvantage salmon in particular. AquaBounty intervened as a defendant to protect its interests in the litigation.

         This lawsuit has been divided into two stages. In the current stage, the Court has been asked to adjudicate four claims. Two of those claims challenge a document in which the FDA explained its authority to regulate genetically engineered animals. As explained in Section II, however, the document does not reflect “final agency action” and therefore is not subject to judicial review. Another claim seeks to set aside approval of the AquAdvantage salmon on the ground that the FDA lacks statutory authority to regulate genetically engineered animals. As explained in Section III, the government prevails on this claim, because the plain language of the FDCA authorizes the FDA to require approval of genetically engineered animals and impose conditions on their use. Finally, the plaintiffs contend that the genetically engineered salmon are dangerous to the environment, and that the FDCA precludes the FDA from approving drugs that are not environmentally safe. As discussed in Section IV, adjudication of this claim will be deferred to the next stage of the case. This claim raises several questions that the parties have not adequately addressed, and in any event these arguments are better considered in the context of the plaintiffs' other targeted challenges to the AquAdvantage salmon approval.


         To explain the basis for its prior assertions of regulatory authority over the creation of genetically engineered animals, the FDA issued a guidance document. This document, which is called “Guidance for Industry 187, ” announces and outlines the FDA's understanding of how the FDCA and its implementing regulations apply to the process of genetically engineering animals. Claim 8 of the plaintiffs' lawsuit alleges that the FDA should have prepared, in connection with the guidance document, a programmatic environmental impact statement pursuant to the National Environmental Policy Act (NEPA). See 40 C.F.R. § 1502.4. Claim 13 targets the FDA's decision not to make the guidance document available in accordance with the notice-and-comment procedures of the Administrative Procedure Act (APA). See 5 U.S.C. § 553.

         Through the FDA Modernization Act of 1997, Congress authorized the FDA to issue guidance documents. Pub. L. No. 105-115, § 405, 111 Stat. 2296, 2368-69 (codified as amended at 21 U.S.C. § 371(h)). That Act empowers the FDA to “develop guidance documents with public participation, ” subject to the limitation that such guidance documents “shall not create or confer any rights for or on any person.” 21 U.S.C. § 371(h)(1)(A). Consistent with the public-participation requirement, the FDA posted notice of a draft version of the guidance document relating to genetically engineered animals, and the agency finalized the document only after the period for public comment had passed. 73 Fed. Reg. 54, 407 (Sept. 19, 2008); 74 Fed. Reg. 3, 057 (Jan. 16, 2009).[2]

         In the guidance document, the FDA defines genetically engineered animals as “those animals modified by rDNA techniques, including the entire lineage of animals that contain the modification.” AR 569.[3] The FDCA provides multiple definitions of the term “drug, ” but the foothold for the FDA's assertion of authority is the phrase “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” 21 U.S.C. § 321(g)(1)(C). According to the guidance document, an “rDNA construct in a GE animal that is intended to affect the structure or function of the body of a GE animal” qualifies as a drug under this provision. AR 572.

         The guidance document then addresses the steps an applicant must take to secure FDA approval of an rDNA construct. AR 578-91. To that end, the document canvasses the existing statutory and regulatory requirements for new animal drugs. See 21 U.S.C. § 360b; 21 C.F.R. § 514.1. In the document, the FDA acknowledged that the “application of some of the statutory and regulatory requirements for new animal drug applications to GE animals may not be obvious, ” but the FDA nonetheless concluded that these generally applicable provisions can sensibly be used in this context. AR 579. The same day it adopted the guidance document, the FDA denied a citizen petition requesting rulemaking tailored to genetically engineered animals on the ground “that it already has a comprehensive regulatory framework in place.” Citizen Petition AR 806 (internal quotation marks omitted).

         Judicial review under the APA extends to “[a]gency action made reviewable by statute and final agency action for which there is no other adequate remedy in a court.” 5 U.S.C. § 704. Section 704 reflects a congressional policy against premature judicial intervention into the administrative process, and in favor of courts resolving only disputes with concrete legal stakes. In Bennett v. Spear, 520 U.S. 154 (1997), the Supreme Court identified the two hallmarks of final agency action: “First, the action must mark the consummation of the agency's decisionmaking process-it must not be of a merely tentative or interlocutory nature. And second, the action must be one by which rights or obligations have been determined, or from which legal consequences will flow.” Id. at 177-78 (internal quotation marks and citation omitted). An action that “carries no direct consequences” and serves “more like a tentative recommendation than a final and binding determination” is not reviewable under the APA. Franklin v. Massachusetts, 505 U.S. 788, 798 (1992).

         The guidance document contains two primary parts: (i) the FDA's interpretation of the term “drug” as including the use of an rDNA construct to create a genetically engineered animal; and (ii) recommendations to applicants regarding the approval process for new animal drugs. The two-step test for finality applies on an issue-by-issue basis. See Navajo Nation v. U.S. Department of Interior, 819 F.3d 1084, 1091 (9th Cir. 2016). In theory, then, both parts, one part, or neither part of the guidance document could be final agency action reviewable under the APA.

         As the D.C. Circuit recently noted, when a guidance document is challenged under the APA, “the finality inquiry is often framed as the question of whether the challenged action is best understood as a non-binding action, like a policy statement or interpretive rule, or a binding legislative rule.” Association of Flight Attendants-CWA, AFL-CIO v. Huerta, 785 F.3d 710, 716 (D.C. Cir. 2015). The plaintiffs argue that the guidance document is a legislative rule; on that basis (and only on that basis), they contend that the guidance document is final agency action. The Ninth Circuit holds that “a rule has the ‘force of law' and is therefore legislative: (1) when, in the absence of the rule, there would not be an adequate legislative basis for enforcement action; (2) when the agency has explicitly invoked its general legislative authority; or (3) when the rule effectively amends a prior legislative rule.” Wilson v. Lynch, 835 F.3d 1083, 1099 (9th Cir. 2016) (internal quotation marks omitted).

         The guidance document fits none of the three categories of legislative rules, so it cannot be considered final agency action based on the argument put forth by the plaintiffs. First, as will be explained in Section III, the statutory drug definition furnishes an adequate legislative basis to consider new-animal-drug applications related to genetically engineered animals. Cf. Hemp Industries Association v. DEA, 33 F.3d 1082, 1090 (9th Cir. 2003).[4] Second, the FDA disavowed resort to its legislative authority to issue the guidance document. AR 571. And third, the guidance document's recommendations to applicants don't effectively amend any legislative rules. The only supposed amendment identified by the plaintiffs is the FDA's suggestion that applicants place “animal care and safety information (e.g., husbandry or containment), ” when relevant, on the drug's label. ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.