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Case 3:16-cv-01574-VC Document 285 Filed 11/05/20 Page 1 of 16
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`UNITED STATES DISTRICT COURT
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`NORTHERN DISTRICT OF CALIFORNIA
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`INSTITUTE FOR FISHERIES
`RESOURCES, et al.,
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`Plaintiffs,
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`v.
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`UNITED STATES FOOD AND DRUG
`ADMINISTRATION, et al.,
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`Defendants.
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`
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`Case No. 16-cv-01574-VC
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`ORDER GRANTING IN PART AND
`DENYING IN PART PLAINTIFFS'
`MOTION FOR SUMMARY
`JUDGMENT; GRANTING IN PART
`AND DENYING IN PART
`DEFENDANTS' CROSS-MOTION
`FOR SUMMARY JUDGMENT
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`Re: Dkt. Nos. 244, 254
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`This case involves a challenge to a decision by the Food and Drug Administration to
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`allow a company to create and farm genetically engineered salmon. As part of the approval
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`process, the FDA assessed the likelihood that the engineered salmon would escape from captivity
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`and adversely affect normal salmon—including salmon species that are endangered. The agency
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`concluded that the engineered salmon were highly unlikely to escape from the two facilities
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`where the company initially planned to raise them, and that even if the salmon found a way to
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`escape they were unlikely to survive or establish themselves as a population in the wild.
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`The FDA did not, however, meaningfully analyze what might happen to normal salmon
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`in the event the engineered salmon did survive and establish themselves in the wild. Even if this
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`scenario was unlikely, the FDA was still required to assess the consequences of it coming to
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`pass. This is especially true because the FDA knew that the company’s salmon operations would
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`likely grow, with additional facilities being used for farming. Obviously, as the company’s
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`operations grow, so too does the risk of engineered salmon escaping. Thus, it was particularly
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`important at the outset for the agency to conduct a complete assessment of the risks posed by the
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`company’s genetic engineering project, including an assessment of the consequences for normal
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`salmon if the engineered salmon established themselves in the wild.
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`Indeed, we now know that the FDA has subsequently given the company permission to
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`operate a third facility. In approving this facility, the agency relied heavily on the analysis it
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`conducted for the first two facilities, even though that analysis had not meaningfully explained
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`what might happen if the engineered salmon were to establish themselves in the wild. Before
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`starting the country down a road that could well lead to commercial production of genetically
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`engineered fish on a large scale, the FDA should have developed a full understanding—and
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`provided a full explanation—of the potential environmental consequences. The agency is ordered
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`to go back and complete the analysis.
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`I
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`In 2015, the FDA approved an application to create and farm genetically engineered
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`salmon submitted by a company called AquaBounty. The salmon, which the company has named
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`“AquAdvantage,” can grow to full size in roughly half the time it takes for normal salmon to
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`mature. In approving the application, the FDA authorized AquaBounty to produce eggs at a
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`facility on Prince Edward Island in Canada and to grow the eggs into mature fish at a facility in
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`Panama, with the understanding that the fish would be sold as food in the United States. The
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`approval was conditioned on the adoption of several measures designed to minimize the risk that
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`the AquAdvantage salmon would escape into the wild, where it might mix with normal salmon.
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`Most prominently, the FDA specified that the salmon must be created and farmed in landlocked
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`facilities; they may not be farmed in “net pens” that connect to the ocean.
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`After the approval, AquaBounty got its operations up and running in Canada and
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`Panama. Since then, AquaBounty shut down the Panama facility and submitted a supplemental
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`application to grow the salmon at a facility in Indiana. The FDA granted this application, again
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`with conditions designed to minimize the risk that the genetically engineered fish would escape.
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`In approving the supplemental application, the FDA relied on and incorporated the original
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`approval.
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` The plaintiffs in this case are a coalition of advocacy and industry groups concerned with
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`the environmental implications of the decision to approve the AquAdvantage salmon.
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`AquaBounty has intervened to defend the approval alongside the FDA and the other government
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`defendants. At a high level, the plaintiffs contend: (i) the FDA’s authority over “drugs” does not
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`give it the power to regulate genetically engineered animals; and (ii) even if the FDA can
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`regulate genetically engineered animals pursuant to its drug authority, the agency unlawfully
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`abused that authority when it approved the AquAdvantage salmon.
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`The Court addressed the plaintiffs’ broader contention regarding the FDA’s authority in a
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`prior ruling, and the current ruling assumes the reader is familiar with the prior one. But in a
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`nutshell, the prior ruling held that although it might initially sound strange to hear that
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`genetically engineered animals come within the FDA’s authority to regulate “drugs,” it turns out
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`that the relevant statutory definition of a “drug” is much broader than its colloquial meaning, and
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`the process of creating and farming genetically engineered animals indeed falls squarely within
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`the agency’s authority. The claims relating to the plaintiffs’ broader attack on the FDA’s
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`authority were thus resolved in favor of the defendants as a matter of law. Institute for Fisheries
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`v. Hahn, 424 F.Supp.3d 740 (N.D. Cal. 2019).
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`What remain are the claims by which the plaintiffs challenge the FDA’s particular
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`decision to approve the AquAdvantage salmon. Although these claims are numerous, and
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`brought under different statutes, they are all based on the assertion that the FDA failed to
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`adequately assess the risk that the salmon would escape and survive in the wild, and the
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`consequences that would result for the environment if this risk materialized. Technically
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`speaking, the plaintiffs have challenged only the FDA’s approval of the original application
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`relating to the facilities on Prince Edward Island and in Panama; they have not challenged the
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`FDA’s supplemental approval for the Indiana facility. Thus, because the Panama facility has
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`been shut down, the primary focus of this case is the Prince Edward Island facility. Nonetheless,
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`the FDA’s approval of the supplemental application relating to the Indiana facility is relevant,
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`because that approval builds on the original one.
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`At this stage, eight claims remain. Six of those claims come under the National
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`Environmental Policy Act (“NEPA”), which requires agencies to consider the potential effect of
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`their actions on the environment, and the Administrative Procedures Act, which instructs federal
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`courts to set aside the actions of federal agencies that fail to comply with statutory requirements.
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`Most prominently, Claim 2 asserts that the FDA violated NEPA by failing to take a sufficiently
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`“hard look” at the environmental consequences of its decision to approve the AquAdvantage
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`application. That claim is closely related to Claim 6, which alleges that in considering the
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`application the FDA was required to prepare a more thorough environmental impact statement,
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`rather than stopping at the less-comprehensive environmental assessment. The other four NEPA
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`claims are simply more specific arguments about the ways in which the FDA’s NEPA analysis
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`was inadequate: that it failed to consider connected, cumulative, and interdependent actions
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`(Claim 3); failed to adequately evaluate cumulative effects (Claim 4); failed to adequately
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`analyze alternatives (Claim 5); and improperly relied on mitigation measures (Claim 7).
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`As for the two non-NEPA claims, Claim 10 alleges that the FDA violated the Endangered
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`Species Act by failing to properly consult with two other agencies, the National Marine Fisheries
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`Service (“NMFS”) and the Fish and Wildlife Service (“FWS”), before taking an action that “may
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`affect” a listed or endangered species—in this case, the population of wild Atlantic Salmon that
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`lives in the Gulf of Maine. Claim 12 alleges that, aside from the environmental statutes, the
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`Food, Drug, and Cosmetic Act (“FDCA”) itself requires the FDA to consider potential
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`environmental impacts when determining whether a drug is “safe for use” within the meaning of
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`that statute.
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`II
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`Before turning to the individual claims, it’s worth discussing a conceptual issue that runs
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`through many of them. The plaintiffs believe that the FDA should have rejected the new drug
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`application based on environmental concerns. But the parties have a fundamental dispute about
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`the extent to which the FDA even has the authority (much less the obligation) to act on those
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`concerns. This dispute is primarily about the scope of the FDCA, which is the statute that
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`authorizes the FDA to exercise regulatory authority over drugs. But it’s also about the interplay
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`between that statute and NEPA.
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`The FDCA instructs the Secretary of Health and Human Services (whose umbrella of
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`authority includes the FDA) to approve a new animal drug application if the drug is “safe for
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`use.” 21 U.S.C. § 360b. The statute gives the word “safe” some context by stating that it “has
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`reference to the health of man or animal.” 21 U.S.C. § 321(u). When the Secretary makes a
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`safety determination, the FDCA requires him to consider:
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`among other relevant factors, (A) the probable consumption of such drug and of any
`substance formed in or on food because of the use of such drug, (B) the cumulative effect
`on man or animal of such drug, taking into account any chemically or pharmacologically
`related substance, (C) safety factors which in the opinion of experts, qualified by
`scientific training and experience to evaluate the safety of such drugs, are appropriate for
`the use of animal experimentation data, and (D) whether the conditions of use prescribed,
`recommended, or suggested in the proposed labeling are reasonably certain to be
`followed in practice.
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`21 U.S.C. § 360b(d)(2). This language suggests that the safety determination focuses singularly
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`on the health of humans and animals, perhaps with a particular focus on those who will, by
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`design, come directly into contact with the drug.
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`For its part, NEPA requires federal agencies undertaking any major action to first
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`consider the impact that action will have on the environment. The statute serves two related
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`purposes. First, it promotes public awareness of the environmental impacts of the actions being
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`contemplated by agencies. Second—and more importantly—it forces the agencies themselves to
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`consider the environmental impact of their actions, giving the agencies an opportunity to change
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`course upon discovering that the impact would be significant. Robertson v. Methow Valley
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`Citizens Council, 490 U.S. 332, 349 (1989).
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`In this litigation, the FDA has taken the narrow position that its decision whether to
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`approve a new animal drug application must be guided by the terms of the FDCA alone. The
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`agency further contends that the FDCA restricts the agency to considering the health and safety
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`of the animal to whom the drug is being administered, the person administering the drug, and any
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`people who might eat the animal for food. Thus, the FDA insists that although it must follow
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`NEPA’s procedural requirements for evaluating and publishing environmental risks, it must
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`ignore the results of that evaluation while deciding whether the new animal drug is safe (and thus
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`deciding whether to approve the application).
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`Even by the terms of the FDCA alone, that position is wrong. Although
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`section 360b(d)(2) mentions factors related to the humans and animals who come into direct
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`contact with the drug, it also requires the Secretary to consider “other relevant factors.” At a
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`minimum, the broad definition of safety given by the statute—that is, having “reference to the
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`health of man or animal”—means that a threat to the health of any human or animal would be
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`properly within the scope of the Secretary’s evaluation. Cf. Natural Resources Defense Council,
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`Inc. v. United States Food and Drug Administration, 760 F.3d. 151 (2d Cir. 2014) (apparently
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`accepting without deciding that the risk posed by antibiotic-resistant bacteria to people other than
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`those who administer antibiotics to pigs could be relevant to animal drug safety). That
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`interpretation also squares well with the FDA’s statutory purpose of “protect[ing] the public
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`health by ensuring that” drugs “are safe and effective.” 21 U.S.C. § 393(b)(2)(B). So even if the
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`FDA is correct that environmental considerations writ large were not relevant to its decision, the
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`agency is always required to consider the subset of environmental impacts that directly involve
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`the health of animals or humans.
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`To say otherwise would seem to create absurd possibilities. Suppose, for example, that a
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`company submitted an application for a drug that would treat a disease in livestock, but the
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`process for manufacturing that drug would invariably contaminate the water supply near the
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`factory in a way that would kill people in the surrounding community. Surely the FDA could
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`deny that application to avoid killing people, even if those people are not directly administering
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`the drug or eating the livestock.1
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`Once NEPA enters the discussion, the FDA’s narrow view of its authority becomes even
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`less defensible. As previously noted, NEPA is largely designed to ensure that agencies take
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`environmental concerns into account when deciding whether to take a particular action. If the
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`FDA were precluded from acting on the concerns that NEPA requires it to consider, the purpose
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`of the statute would be largely undermined. “When confronted with two Acts of Congress
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`allegedly touching on the same topic,” courts must “strive to give effect to both.” Epic Systems
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`Corp. v. Lewis, 138 S. Ct. 1612, 1624 (2018) (quoting Morton v. Mancari, 417 U.S. 535, 551
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`(1974)). Thus, to the extent that the FDCA itself is unclear on whether the FDA may impose
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`conditions or deny a permit application based on environmental concerns, the presence of NEPA
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`counsels in favor of a broader understanding of the agency’s authority. See Natural Resources
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`Defense Council, Inc. v. United States Environmental Protection Agency, 859 F.2d 156, 170
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`(D.C. Cir. 1988) (explaining that EPA may impose “NEPA-inspired” conditions on permits for
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`discharge of pollutants under the Clean Water Act). Perhaps it would be different if the FDCA
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`explicitly precluded the agency from considering environmental concerns (even environmental
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`concerns that directly affect the health of humans and animals), but the statute does no such
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`thing.2
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`In sum, the FDA was required to consider—and had the authority to act upon—concerns
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`1 The narrow interpretation of its own authority that the FDA has taken in this litigation does not
`appear to match up with the agency’s prior statements and actions. For example, in its Guidance
`for Industry on Regulation of Genetically Engineered Animals Containing Heritable
`Recombinant DNA Constructs, the agency stated that “environmental risks are among the factors
`we intend to consider in determining whether to exercise enforcement discretion.” Guidance for
`Industry 187. And indeed, the FDA conducted an Environmental Safety Review of AquaBounty
`salmon in accordance with that Guidance. See Dkt. No. 269 at 111–39. Nor has the FDA pointed
`to any other instance in which it has taken the position (much less acted on the position) that it is
`not permitted to make decisions or take actions based on environmental concerns created by the
`drugs it considers for approval. The agency’s position is thus not entitled to Chevron-style
`deference. United States v. Mead Corporation, 533 U.S. 218, 229–31 (2001).
`2 Indeed, the presence of NEPA suggests that perhaps the FDA may take account of
`environmental effects writ large, rather than merely effects that directly impact humans and
`animals, when deciding whether to approve a drug. But that question is not presented here,
`because the only environmental effects at issue in the case relate to the effect of the
`AquAdvantage salmon on normal salmon.
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`regarding the effect of the AquAdvantage salmon on normal salmon. The remaining sections
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`discuss whether the agency complied with its legal obligations in this regard.
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`III
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`In Claims 2 and 6, the plaintiffs assert that the FDA violated NEPA by concluding that
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`approval of the new drug application would not have a significant impact on the environment—
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`specifically, on wild salmon. The plaintiffs contend that AquaBounty’s operations on Prince
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`Edward Island will likely have a significant impact on wild salmon, and that the agency was
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`therefore required under the statute to prepare an environmental impact statement before
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`deciding whether to approve the application.
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`NEPA requires the FDA and other federal agencies to prepare a detailed environmental
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`impact statement for any major action “significantly affecting the quality of the human
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`environment.” 42 U.S.C. § 4332(2)(C). As a preliminary step, an agency may choose to prepare
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`a more concise “environmental assessment” that simply analyzes whether the proposed project
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`would have a “significant” environmental impact, and thus whether the agency must prepare a
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`full-blown environmental impact statement or may instead issue a “finding of no significant
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`impact.” Blue Mountains Biodiversity Project v. Blackwood, 161 F.3d 1208, 1212 (9th Cir.
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`1998); 40 § C.F.R. 1508.9.
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`The conclusion the agency reaches in the environmental assessment (that is, whether to
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`prepare an environmental impact statement or issue a finding of no significant impact) is subject
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`to judicial review under the Administrative Procedures Act. The decision may be reversed only if
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`it is found to be “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance
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`with law.” 5 U.S.C. § 706(2)(A). Under this rule, a court reverses the determination if the agency
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`has failed to take a sufficiently “hard look” at the question. Blue Mountains, 161 F.3d at 1211.
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`An agency’s decision not to prepare an environmental impact statement is considered arbitrary
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`and capricious if the agency “fails to supply a convincing statement of reasons why potential
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`effects are insignificant.” Id. (quoting Save the Yaak Committee v. Block, 840 F.2d 714, 717 (9th
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`Cir. 1988)). Plaintiffs challenging the agency’s decision will succeed in their claim if
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`“substantial questions are raised” as to whether the proposed project will have significant
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`environmental impacts. Blue Mountains, 161 F.3d at 1212 (quoting Idaho Sporting Congress v.
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`Thomas, 137 F.3d 1146, 1149 (9th Cir. 1998)).
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`Here, the FDA did not adequately explain in its environmental assessment why the
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`potential impacts of the production and growth of engineered salmon will be insignificant. The
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`central problem is that the document failed to conduct the very inquiry it stated was necessary. In
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`the section describing the “approach to assessment,” the environmental assessment stated that an
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`analysis of environmental risk would need to consider two probabilities: the probability of
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`“exposure,” or a bad event, and the probability of harm that could occur given exposure.
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`Environmental Assessment § 3.1. The document thoroughly analyzed the probability of
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`exposure, concluding that it was low. But it failed to assess and explain the potential
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`consequences of that low probability being realized.
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`For the engineered salmon project, there are several steps in the chain of an “exposure.”
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`First, the engineered salmon may escape from their physical confinement. Second, they may
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`survive in the wild. Third, they may directly interact with wild salmon, such as by mating or
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`simply by competing for resources. Fourth, the engineered salmon may “establish,” meaning that
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`they could breed and produce a stable population that persists outside of captivity indefinitely.
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`The “probability of exposure” therefore considers the likelihood that all these steps may occur.
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`The FDA did a careful job on this step of the equation. It marshalled a great deal of evidence to
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`show that the probability of engineered salmon escaping, surviving, and establishing a
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`population is quite low. See Environmental Assessment § 7.5. And in the course of assessing the
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`probability of exposure, the FDA did evaluate the risk of harm resulting from each of those
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`intermediate steps in the exposure chain. Effectively, the agency found that the harm given
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`escape is low because the engineered salmon are unlikely to survive long enough to do any
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`damage; the harm given survival is low because the engineered salmon are unlikely to interact
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`with wild salmon; and even the harm given interaction is low because the engineered salmon are
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`not likely to establish a population.
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`But the analysis contained in the environmental assessment essentially stopped without
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`assessing the possibility of harm to the natural salmon species in the unlikely event of genetically
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`engineered salmon establishing themselves in the wild. That means that the second variable in
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`the FDA’s own risk equation, the likelihood of harm given exposure, remains unknown. Because
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`the FDA did not fully carry out the risk analysis it prescribed for itself, the finding that approving
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`the production and growth of these salmon will have no significant impact falls short of being a
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`“convincing statement.” Blue Mountains, 161 F.3d at 1211.3
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`Up to this point, a reader could not be blamed for wondering if the plaintiffs are winning
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`their NEPA claim on little more than a technicality. If the agency did a careful job of analyzing
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`and explaining why there is a very low risk of escape, survival, and establishment in the wild,
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`why should it be required to go back and analyze the potential consequences of these remote
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`risks being realized? Part of the answer is simply what the FDA itself acknowledged in the
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`environmental assessment: a proper hazard assessment requires the equation to be completed in
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`this fashion. But a more compelling answer lies in the NEPA regulations. In particular, agencies
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`must evaluate the “context” and “intensity” of a proposed action by considering ten “intensity
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`factors.” 40 C.F. R. § 1508.27(b). The sixth factor, which requires the agency to consider the
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`“degree to which the action…represents a decision in principle about a future consideration,”
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`helps show why the requirement to assess the consequences of establishment in the wild is not a
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`mere technicality. 40 C.F.R. § 1508.27(b)(6).
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`The new animal drug application clearly contemplated that the engineered salmon eggs
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`produced at the Prince Edward Island facility would be transported elsewhere to be “grown out”
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`3 One scientist opined that “selection over time would be expected to simply purge the transgene
`from any established population, suggesting a low probability of harm resulting from exposure to
`AquAdvantage salmon.” Environmental Assessment § 7.5.1.1 (quoting Dr. William Muir). But
`even if such a purge did occur, what of the impacts on wild salmon from the added competition
`of a new population of fish? And how would the gene be “purged” if not by interbreeding with
`wild salmon? The environmental assessment does not even raise these questions, let alone
`address them.
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`into fish. That implies at least a significant possibility that future applications would seek
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`approval to build additional grow-out facilities at other locations. With every new facility built,
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`the possibility of exposure grows. Understanding the harm that could result from that exposure—
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`and having an explanation of it on record—will only become more important. And if that issue is
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`not properly assessed at the outset, it may never be. The Indiana facility, for example, was
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`approved with a “supplemental” environmental assessment based on the one created for the
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`Prince Edward Island and Panama facilities’ application. Although the adequacy of that
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`supplemental assessment is not at issue in this litigation, the fact of its reliance on the initial
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`assessment demonstrates the importance of ensuring that the FDA analyzed the risk thoroughly
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`at the outset.
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`To be sure, the FDA is correct that it was not required to formally consider future
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`projects that had not yet been submitted for approval. But this does not mean it would be
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`appropriate to conduct its analysis of the proposed action without taking account of the obvious
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`likelihood that future actions would build on it. It is not enough for the FDA to declare with
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`respect to this initial project that the risk of exposure is so small as to justify forgoing analysis of
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`the risk of harm given exposure. The NEPA regulations underscore that point by making
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`possible future developments relevant to an evaluation of the environmental significance of any
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`agency’s actions.
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`Accordingly, on remand the FDA must complete the final step of its own risk analysis by
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`addressing the consequences that would result from the engineered salmon successfully
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`establishing a persistent population outside of captivity. The results of that revised analysis may
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`show that an environmental impact statement is required, but they may also show that a finding
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`of no significant impact is appropriate.4
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`4 The remainder of plaintiffs’ NEPA claims—Claims 3, 4, 5, and 7—are easily adjudicated in
`favor of the defendants. The plaintiffs have not demonstrated that there were any connected,
`cumulative, or interdependent actions before the FDA for consideration at the time of this
`environmental assessment, nor that there were cumulative impacts from prior agency actions that
`needed to be considered. Compare Blue Mountains, 161 F.3d at 1214–15 (agency was required
`to consider the cumulative impacts of five potential projects in the same watershed). Nor was the
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`IV
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`Section 7 of the Endangered Species Act (“ESA”) instructs agencies to determine
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`whether a proposed action “may affect listed species or critical habitat.” 16 U.S.C. § 1536(a)(2);
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`50 C.F.R. § 402.14. If so, the agency is required to consult with the National Marine Fisheries
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`Service (“NMFS”) and the Fish and Wildlife Service (“FWS”) before proceeding. In a strange
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`sequence of events: NMFS and FWS initially urged the FDA to undergo a Section 7 consultation
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`regarding the AquaBounty operations; the FDA took the view that the production of the
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`AquAdvantage salmon “may affect” endangered salmon, thus triggering the consultation
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`requirement; then FWS prodded FDA to change its “may affect” determination to a “no effect”
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`determination, the result being that formal consultation among the agencies would not be
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`required; and thereafter the FDA issued a formal statement that approval of the engineered
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`salmon would have no effect on the endangered species. See Institute for Fisheries Resources v.
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`Burwell, No. 16-cv-01574-VC, 2016 WL 4529517, at *1 (N.D. Cal. Aug. 30, 2016). In Claim 10,
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`the plaintiffs contend the FDA violated the ESA by failing to consult with the expert agencies,
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`rendering the approval of AquaBounty’s application arbitrary and capricious within the meaning
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`of the APA.
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`It is instructive to compare the requirements under the ESA to those under NEPA.
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`Whereas NEPA asks the agency to identify and prepare an environmental impact report for
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`“significant” impacts on any aspect of the environment, the ESA requirements are triggered by a
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`lower threshold, but for a narrower set of impacts. The agency must identify any potential effect,
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`however small, on listed species and consult with the relevant agencies about the proposed
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`action. See Karuk Tribe of California v. U.S. Forest Service, 681 F.3d 1006, 1027 (9th Cir.
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`environmental assessment deficient in the number of alternatives it analyzed (although to the
`extent that its risk assessment of the proposed action was insufficient, so too was the application
`of that assessment to the no action alternative). Earth Island Institute v. U.S. Forest Service, 697
`F.3d 1010, 1022 (9th Cir. 2012) (noting that NEPA’s “statutory and regulatory requirements do
`not dictate the minimum number of alternatives that an agency must consider”) (internal citations
`and quotations omitted). Arguments that the FDA improperly relied on mitigation strategies also
`fall short, because the agency did nothing but rely on the enforceable conditions of approval
`embedded in the application.
`
`12
`
`

`

`Case 3:16-cv-01574-VC Document 285 Filed 11/05/20 Page 13 of 16
`
`
`
`2012).
`
`In this case, the NEPA and ESA review processes shared a single focus. The NEPA
`
`evaluation addressed the potential impacts of engineered salmon on wild salmon; the ESA
`
`analysis was also concerned with wild salmon, albeit more specifically the endangered Gulf of
`
`Maine Atlantic salmon. Because the FDA did not sufficiently examine whether the engineered
`
`salmon would significantly impact wild salmon under NEPA, it follows that the agency cannot
`
`defend its conclusion that the engineered salmon would have no effect at all on Gulf of Maine
`
`salmon. Indeed, the fact that the FDA apparently reached a conclusive determination that the
`
`AquaBounty salmon would have “no effect” on the Gulf of Maine Salmon in 2010, while the
`
`environmental assessment was still under active consideration and five years before the NEPA
`
`process was completed, suggests that the agency may have failed to grasp the practical
`
`relationship between the two statutes’ requirements in this case. Accordingly, the plaintiffs
`
`prevail on this claim as well. On remand, the FDA must reconsider its “no effect” determination
`
`under the ESA together with its revised NEPA evaluation. Or perhaps, as it apparently tried to do
`
`early on, it should initiate consultation with NMFS and FWS about whether AquaBounty’s
`
`application would have an effect on endangered salmon, so that the conclusions the FDA
`
`ultimately reaches in its environmental assessment are supported by the guidance of the expert
`
`agencies.
`
`
`
`V
`
`In Claim 12, the plaintiffs contend that the FDA violated its own authorizing statute—the
`
`FDCA—when it approved AquaBounty’s application. According to the plaintiffs, flaws in the
`
`agency’s analysis of potential environmental harms amount not only to a violation of NEPA and
`
`the ESA, but also the FDCA, meaning that the approval was arbitrary and capricious within the
`
`meaning of the APA for that reason as well.
`
`As already discussed in Section II, the language of the FDCA is, at a minimum, broad
`
`enough to require the FDA to consider impacts on the health of any human or animal when
`
`13
`
`

`

`Case 3:16-cv-01574-VC Document 285 Filed 11/05/20 Page 14 of 16
`
`
`
`reviewing safety. The agency may deny a permit application if it concludes that adverse impacts
`
`on humans and animals render the drug unsafe. And again, the core environmental concern with
`
`respect to the engineered salmon is that they might escape and ultimately impact the health of
`
`wild salmon and fish populations. Thus, to the extent that the FDA responds to this claim by
`
`arguing it would not be allowed to consider impacts on wild salmon as part of its “safety”
`
`analysis even if it wanted to, that argument is wrong.
`
`But ironically, it does not follow that the FDA loses on this claim, because the FDA did
`
`take measures that prevent the genetically engineered salmon from mixing with wild salm

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