By Jay W. Cormier –
Just a little more than four months after FDA approved AquAdvantage Salmon (AAS) – the first genetically engineered (GE) animal intended for food use – several organizations filed suit against FDA and the U.S. Fish and Wildlife Service (FWS) challenging that approval. Plaintiffs include the Center for Food Safety (not to be confused with FDA’s Center for Food Safety and Applied Nutrition, or CFSAN), Earthjustice, and Food and Water Watch, among others. As we predicted when FDA approved AquaBounty’s AquAdvantage Salmon last November, Plaintiffs filed suit and allege that FDA and FWS violated various statutes, including the FDCA, the Administrative Procedures Act (APA), the National Environmental Policy Act (NEPA), and the Endangered Species Act (ESA).
Without going through each of the thirteen alleged causes of action and the twelve actions requested of the U.S. District Court for the Northern District of California, we briefly discuss the merits of the case below. For a detailed description of AAS, see our earlier post regarding Food and Water Watch’s petitions to FDA, which FDA denied when the agency approved the new animal drug application (NADA) for AAS.
Plaintiffs claim that the FDCA does not grant FDA the authority to approve NADAs for GE animals. Recall that FDA has asserted its authority over GE animals through the “structure-function” clause of the drug definition. That clause defines a drug as any article “intended to affect the structure or any function of the body of man or other animals.” FDCA § 201(g)(1)(C). FDA has argued for over a decade that the recombinant DNA (rDNA) construct used to genetically engineer AAS is an article that is intended to affect the structure and function of the body of the salmon, and, therefore, the rDNA construct meets the statutory definition of a drug. Because the construct is present in the genome of the salmon, and is heritable from one generation to the next, FDA has argued that it has jurisdiction over the salmon itself in perpetuity.
Plaintiffs’ claim that FDA lacks statutory authority to approve NADAs for GE animals faces two hurdles. First, a government agency generally is given deference when the agency is interpreting a statute it administers (referred to as Chevron deference). FDA will likely argue that its regulation of GE animals as new animal drugs is consistent with the plain meaning of the statute, and, to the extent that there is any ambiguity in the statute on this point, that FDA’s interpretation of the statute is reasonable. Second, the District Court for the District of Columbia has implicitly addressed FDA’s jurisdiction over GE animals. In International Center For Tech. Assess. v. Thompson, 421 F.Supp.2d 1 (D.D.C. 2006), the court considered whether FDA’s exercise of enforcement discretion over GE ornamental zebrafish was permissible. Because FDA would not be able to exercise enforcement discretion if it had no jurisdiction over GE animals, the court’s finding that FDA’s actions were lawful implies that FDA has the statutory authority to regulate these animals. Although the court wasn’t asked to specifically address FDA’s jurisdiction by either party, it would be surprising if FDA were to ignore such a helpful precedent in its filings in the AAS case.
The bulk of Plaintiffs’ case revolves around allegations of violations of NEPA. While the NEPA issues are numerous, in essence, Plaintiffs allege that FDA’s environmental assessment and finding of no significant impact failed to consider the environmental impact of future GE salmon grow-out facilities, failed to consider alternative actions, and relied excessively on risk mitigations strategies.
In alleging that the scope of NEPA review was deficient, Plaintiffs seem to ignore the fact that a drug approval is limited to the specific manufacturing sites that are encompassed in that approval. FDA and AquaBounty have stated that any new GE salmon hatcheries or grow-out facilities will be considered changes to an application that will require approval from FDA prior to implementation. Thus, adding any new facility will trigger a new agency action that will require its own NEPA analysis, and these subsequent approvals may need to consider cumulative effects on the environment. Until then, it is not clear how FDA could conduct an environmental analysis of fictitious facilities in unknowable locations, as Plaintiff’s position would appear to require.
With respect to alternative actions FDA could have taken, Plaintiffs allege that FDA could have considered the “development of new projects and policies designed to support and expand sustainable commercial fishing or aquaculture practices; actions to protect and restore native Atlantic salmon populations; and non-GE alternatives to developing ‘faster growing’ salmon . . . .” Complaint at paragraph 191. Not surprisingly, Plaintiffs point to no statutory authority under which FDA could achieve any of those purposes, however laudable those purposes may be.
Finally, Plaintiffs allege that the risk mitigation strategies required of AquaBounty are unenforceable, and, therefore, FDA cannot rely on those strategies to come to a finding of no significant impact. Given FDA’s broad statutory authority to inspect foreign and domestic facilities, and FDA’s long history of taking enforcement action based on such inspections, it will be interesting to see how this line of reasoning plays out in the courts.
Plaintiffs also allege that there were violations of the ESA because FDA failed to adequately consult with other government agencies (such as FWS) regarding whether the approval “may affect” wild Atlantic salmon, an endangered species. However, FDA’s final environmental assessment of AAS includes a letter from FWS that states “[FDA’s] ‘no effect’ determination seems well supported for this approval.” That same document includes a letter from the National Oceanic and Atmospheric Administration’s National Marine Fisheries Service that identifies eight meetings between that agency and FDA regarding the potential effects (or lack thereof) of an approval on wild Atlantic salmon populations.
Plaintiffs also allege that, under the ESA, once FDA determined there were “no effects” of approving AAS on endangered species, FDA was not permitted to consult with, and seek concurrence from, other agencies. It is not clear what a victory for Plaintiffs on this point would gain.
Potentially Broad Implications
In a Wall Street Journal article regarding the AAS lawsuit, one of the attorneys for the plaintiffs is reported as saying that “the groups’ lawsuit is aimed at GMO animals raised for food production, though it could ‘indirectly affect’ the FDA’s jurisdiction over other modified animals.” This is a curious characterization of the scope of the lawsuit, given that the first claim in the complaint alleges that FDA lacks the jurisdiction to approve GE animals in toto. In any event, the import of this “indirect effect” acknowledged by Plaintiffs should not be lost on our readers. One of the interesting consequences of a victory for Plaintiffs would be that FDA would no longer have the statutory authority to regulate GE animals, absent circumstances that trigger application of another statutory provision. Because no other federal agency would appear to have authority to regulate the kinds of GE animals currently regulated by FDA, those animals might not face any regulatory hurdle before marketing. This result would seem to go against Plaintiffs’ interests and play to the hands of those who have argued against any regulation of GE animals. What would come next is unclear. Congress could enact clarifying legislation to explicitly give FDA jurisdiction over these GE animals, but the prospects for that type of legislation appear highly uncertain.
Defendants must file a responsive pleading within 60 days of being served the complaint. We will continue to closely watch developments in this case.