Innovations in genetic engineering have provided us with advancements in medicine, agriculture, food, and other applications. More recently, genetic engineering has been used to create the technology to combat COVID-19. While genetic engineering has stirred passionate debates between its defenders and detractors, a recent federal court decision has attempted to settle one dispute: whether the Endangered Species Act (ESA) applies to the U.S. Food and Drug Administration’s approval of genetically engineered (GE) animals for consumption as food. 

In Institute for Fisheries Resources v. U.S. Food & Drug Administration, the U.S. District Court for the Northern District of California held that FDA failed to comply with the ESA when authorizing AquaBounty Technologies Inc. to grow genetically engineered salmon (branded '“AquaAdvantage”) in landlocked pens. The court found that “FDA failed to adequately assess the risk that the salmon would escape and survive in the wild.” Under that scenario, the court explained that “FDA was required to consider—and had the authority to act upon—concerns regarding the effect of the AquaAdvantage salmon on normal salmon,” which are protected under the ESA. On remand, FDA was directed to analyze and address “the consequences that would result from the engineered salmon successfully establishing a persistent population outside of captivity.”

Given this court decision and others that will inevitably follow, companies should work closely with their counsel and consultants to ensure that FDA complies with its obligations under the ESA when seeking FDA approval of a GE animal or contemplating seeking approval for other potentially controversial products. 

The court’s decision reflects a changing dynamic that we have observed in recent years across the food, drug, and agriculture landscape. Long gone are the days where an agency can approve a product while avoiding scrutiny from external stakeholders who are looking for any legal vulnerabilities with the decision, including failure to meet the requirements of the ESA. FDA’s review and approval of GE animals—a frequently debated technology—clearly falls within the scope of this increased scrutiny, as likely will other agency decisions.

For more information on this issue and the court’s decision, please read “Genetic Engineering and the Endangered Species Act,” which I co-authored with my Wiley colleagues Ann Begley and Hume Ross.  Our article was originally published in Law360.