Genetically Modified Salmon

This issue tracker covers federal statutes, regulatory actions and litigation addressing genetically modified salmon and selected prior events for historical purposes and additional clarity. Our goal is to provide a comprehensive listing of statutes and regulations, but the litigation covered is not exhaustive and focuses on selected issues receiving national attention. This issue tracker covers the period from 2015 to present.  

Note: This Issue Tracker will keep track of federal legislative actions following the signing of the 2016 Consolidated Appropriations Act and will also list and track prior events for historical purposes and additional clarity.

12.18.15 – U.S. President Barack Obama signed into law the 2016 Consolidated Appropriations Act, prohibiting import of AquAdvantage salmon until FDA mandates final labeling guidelines for consumers. The 2016 Act states, “not less than $150,000 shall be used to develop labeling guidelines and implement a program to disclose to consumers whether salmon offered for sale to consumers is a genetically engineered variety.”

This section will keep track of federal regulatory developments following the signing of the 2016 Consolidated Appropriations Act and will also list and track prior events for historical purposes and additional clarity.

A. U.S. Food and Drug Administration (FDA)

Note: On May 10, 2021, genetically engineered (GE) salmon producer AquaBounty announced that it had received purchase orders for all five metric tons of its first harvest of GE Atlantic salmon, due at the end of May, from the company’s Albany, Indiana facility. According to the announcement, AquaBounty will increase its production to full capacity through the end of the year. AquaBounty is currently the only company producing U.S. Food and Drug Administration (FDA)-approved GE Atlantic salmon. 

4.8.19 – The FDA announced the deactivation of an import alert 99-40 that had previously prevented genetically engineered (GE) salmon from entering the U.S.

4.26.18 – The FDA granted AquaBounty permission to raise AquAdvantage salmon at a land-based contained facility near Albany, Indiana; however, the FDA states, “While the Indiana facility is approved for production, the company is prohibited from importing the eggs necessary for producing genetically engineered (GE) salmon at the facility because of a requirement in FDA’s current appropriations law.”

1.19.17 – The FDA published a draft revised guidance for public comment, whose purpose is to broaden the scope of the existing GFI # 187 to address “animals with intentionally altered genomic DNA developed through use of genome editing technologies, as well as techniques such as rDNA in genetic engineering,” including the AquAdvantage salmon.

1.29.16 – Consequent to the 2016 Consolidated Appropriations Act, the FDA issued a related Import Alert 99-40 prohibiting the import of AquAdvantage salmon eggs into the United States. (Link to primary sources removed from FDA website due to March 8 order)

11.24.15 – The FDA published in the Federal Register a Final Rule amending the animal drug regulations (21 CFR part 258) to take into account the approval of AquaBounty Technologies’ NDA.

11.19.15 – The FDA formally approved the NDA from AquaBounty Technologies to produce AquAdvantage salmon for human consumption, provided that certain conditions are met regarding manufacturing methods, facilities and controls, labeling, registration and listing, inspections, and post-market records and reports of adverse events and other experiences.

11.12.15 – The FDA issued a Finding of No Significant Impact (FONSI) based on a Final Environmental Assessment (EA) in support of an approval of a New Animal Drug Application related to AquAdvantage Salmon. The FDA concluded that “the action to approve the NADA for AquAdvantage Salmon would not individually or cumulatively have a significant effect on the quality of the human environment in the United States.”

5.4.12 – The FDA published a Draft Environmental Assessment (EA) as well as a preliminary Finding of No Significant Impact (FONSI) in support of a New Animal Drug Application (NADA) submitted by AquaBounty Technologies for production of a genetically engineered (GE) Atlantic salmon, the AquAdvantage salmon. The EA and preliminary finding are subject to a 120-day public comment period.

1.15.09 – The FDA issued Guidance for Industry (GFI) # 187 to clarify FDA’s requirements and recommendations under the Food, Drug and Cosmetic Act (FDCA) applicable to genetically engineered (GE) animals containing heritable recombinant DNA constructs. The Guidance was then revised in June 2015.

A. Institute for Fisheries Resources, et al. v. Hahn, et al.
(USDC N.D. California, No. 3:16-cv-01574)
(Ninth Circuit, No. 21-15640)

4.22.21 – The Ninth Circuit Court of Appeal ordered dismissal of the case. 

4.21.21 – The U.S. Food and Drug Administration (FDA) filed a motion to dismiss its recent appeal of the district court’s decision ordering the agency, without vacatur, to address defects in its approval analysis for bio-engineered salmon. 

4.12.21 – The U.S. Food and Drug Administration (FDA) filed a notice appealing to the U.S. Court of Appeals for the Ninth Circuit the November 2020 decision of the U.S. District Court, which granted summary against the agency and ordered it to redo its analysis supporting its approval of bioengineered salmon. 

11.12.20 – The district court entered judgment in favor of the plaintiffs as to Claims 2, 6, and 10 and in favor of the defendants as to all other pending claims. 

11.5.20 – The district court issued an order granting summary judgment against the Food and Drug Administration (FDA) in a challenge to its approval of bio-engineered salmon farming. According to the opinion, although FDA determined that the possibility of bio-engineered salmon escape was highly unlikely, the court found that the agency failed to meaningfully analyze the potential effects to the wild salmon population if the bio-engineered salmon were to escape and establish themselves as a population. The court, however, declined to vacate the agency action, instead ordering the agency to “go back and complete the analysis,” and stated that a vacatur would call for the destruction of the existing genetically engineered salmon, “a significant loss of property and animal life that would be wasteful given the real possibility that the FDA will be able to cure the … errors on remand.”

3.26.20 – Plaintiffs filed a Motion for Summary Judgment on remaining claims.

12.19.19 – Judgment entered granting in part and denying in part Defendants’ Motion for Judgment on the Pleadings; denying Plaintiffs’ Motion for Summary Judgment. 

3.16.16 – Institute for Fisheries Resources filed a lawsuit against FDA disputing the agency’s approval of AquaBounty application to produce AquAdvantage salmon for human consumption.

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