January 21, 2020

Overview of the Regulatory and Legal Developments Surrounding the FDA Approved Genetically-Modified Atlantic Salmon

Written by Chloe Marie – Research Specialist

Background

The AquAdvantage salmon is a genetically modified Atlantic salmon developed by AquaBounty Technology, a Massachusetts-based company. The technology behind the AquAdvantage® salmon originated from the discovery in 1989 of advanced molecular genetics that enabled the grow-out period of the fish to be reduced. Specifically, the AquAdvantage® technology consists of integrating the Chinook salmon growth hormone gene into the genome of the Atlantic salmon; thus, enabling the Atlantic salmon to grow faster and end up more quickly on our plates.

Unlike Canada which approved commercial production of the genetically-modified fish in November 2013, the regulatory process in the United States has moved more slowly to approve AquAdvantage® salmon production and, despite the technology being available since the 1990s, it is only very recently that the selling of AquAdvantage® salmon to U.S. customers has come close to fruition.

About 20 years ago, AquaBounty filed a New Animal Drug (NAD) application with the U.S. Food & Drug Administration (FDA) to produce AquAdvantage® salmon for human consumption. In August 2010, FDA announced that it would hold a public hearing regarding the labeling of food derived from AquAdvantage® salmon as well as a public Veterinary Medicine Advisory Committee (VMAC) meeting. FDA made the following findings that the consumption of AquAdvantage® salmon would be equally as safe as salmon that are non-genetically modified even though many environmental and labeling concerns were raised among legislators and the public.

In December 2012, FDA published a Draft Environmental Assessment (EA) as well as a preliminary Finding of No Significant Impact subject to a 120-day public comment period. According to FDA, a total of approximately 38,000 comments were made; however, the agency “determined that approximately 90 specific comments from nearly 70 different organizations and individuals were responsive to the … draft EA or preliminary FONSI and were substantive in nature.”

FDA’s Approval of the AquAdvantage Salmon Production

On November 19, 2015, FDA approved the New Animal Drug Application (NADA) from AquaBounty Technologies to produce AquAdvantage® salmon for human consumption. FDA issued a Finding of No Significant Impact (FONSI) based on a Final Environmental Assessment (EA) issued on November 12, 2015. FDA determined that AquAdvantage salmon production would not jeopardize the existence of Atlantic salmon populations or adversely impact their critical habitat, but required production to take place under certain conditions described in FDA’s approval letter regarding manufacturing methods, facilities and controls, labeling, registration and listing, inspections, and post-market records and reports of adverse events and other experiences.

The approval of the AquAdvantage® salmon in 2015, however, raised serious objections from major U.S. retailers, including, but not limited to, Whole Foods, Safeway, Target, Walmart, Trader Joe’s and Costco. Just one day following the FDA approval, Costco Wholesale issued a short but clear statement whereby it declared that “Although the FDA has approved the sale of GM salmon, Costco has not sold and does not intend to sell GM salmon at this time.” Similarly, Safeway notified Friends of the Earth in writing via email that “Should GE salmon come to market, we are not considering nor do we have any plans to carry GE salmon. The seafood products we offer will continue to be selected consistent with our Responsible Seafood Purchasing Policy, Responsible Sourcing Commitment and our partnership with FishWise.” Katherine Neebe, Director of Sustainability at Walmart, also wrote in an email dated May 2016 that the company’s policy is “committed to finding safe, affordable and sustainable food for our customers that does not negatively affect global communities or the environment” before adding that “Walmart has no plans to sell GMO-salmon.”

The approval process appeared to recognize these market concerns when President Barack Obama signed the 2016 Consolidated Appropriations Act on December 18, 2015, which prohibited the import of AquAdvantage® salmon until FDA mandated final labeling guidelines for consumers. The 2016 Consolidated Appropriations Act specifically stated that “[o]f the amounts made available to the Food and Drug Administration, Salaries and Expenses, 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.” Consequently, FDA issued a related Import Alert 99-40 based on the terms of the Appropriations Act forbidding the import of AquAdvantage® salmon eggs into the United States. These terms were also included in the 2017 and 2018 Omnibus Appropriations Acts.

On April 26, 2018, FDA granted AquaBounty permission to raise AquAdvantage® salmon at a land-based contained facility near Albany, Indiana; however, FDA strictly stated that the company remained subject to the prohibition on importing the eggs necessary for the production of genetically-modified salmon into the United States.

Lifting of Ban on Importation of Salmon Eggs

In March 2019, the Food & Drug Administration (FDA) Commissioner Scott Gottlieb announced that the Import Alert 99-40 banning imports of genetically-modified salmon engineered using the AquAdvantage® technology had been deactivated. According to FDA Commissioner Gottlieb, this decision could be reached after the U.S. Department of Agriculture had successfully fulfilled the Congressional mandate under the National Bioengineered Food Disclosure Standards to implement regulations for disclosure of bioengineered food and ingredients.

Following the lifting of the ban on imports of AquAdvantage® salmon into the U.S. on March 8, 2019, FDA Commissioner Gottlieb declared that “AquAdvantage Salmon eggs can now be imported to the company’s contained grow-out facility in Indiana to be raised into salmon for food.” Prior to the lifting of the import ban, AquAdvantage® salmon eggs were produced at the Prince Edward Island-based facility in Canada and subsequently transported to the Panamanian highlands to grow into adult fish. The genetically-modified fish were then shipped back to Canada where the first AquAdvantage® salmon was marketed in August 2017.

FDA’s Guidance for Industry # 187

FDA issued Guidance for Industry (GFI) # 187 that aimed to clarify FDA’s requirements and recommendations under the Food, Drug and Cosmetic Act (FDCA) applicable to genetically engineered (GE) animals. GFI # 187 is entitled “Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs” and specifically interprets and explains how GE animals meet both FFDCA definitions of “drug” and “new animal drug.” It was initially published in January 2009 and then first revised in June 2015.

On January 19, 2017, FDA published a draft revised guidance for public comment for the purpose of broadening 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. FDA is currently working on the final version of the guidance.

AquAdvantage Salmon Related-Litigation

Institute for Fisheries Resources et al. v. Hahn et al., No. 3:16-cv-01574

On March 30, 2016, the Institute for Fisheries Resources along with ten environmental groups brought legal action against FDA before the U.S. District Court for the Northern District of California disputing FDA’s approval of AquaBounty application to produce AquAdvantage salmon for human consumption. Specifically, the environmental groups argued that FDA failed to properly consider the potential environmental and ecological impacts from the AquAdvantage salmon production.

Plaintiffs alleged that FDA should have prepared an Environmental Impact Statement (EIS) instead of an Environmental Assessment (EA) / Findings of No Significant Impact (FONSI) as producing AquaBounty’s GE salmon is a major federal action that could significantly affect public health and the environment; and thus, violated several federal statutes, including among others the Food, Drug and Cosmetics Act (FDCA), the National Environmental Policy Act (NEPA) and the Administrative Procedure Act (APA).

Plaintiffs also challenged FDA’s statutory authority in reviewing and approving the genetic engineering of the AquAdvantage® salmon as a “new animal drug” pursuant to FDCA. According to plaintiffs, the plain language of the statute did not give FDA explicit authority to regulate GE animals, and plaintiffs argued that the position of FDA, expressed in Guidance for Industry # 187, that interpreted GE animals as a “new animal drug” pursuant to the FDCA was in error.

In August 2018, FDA motioned the District Court for judgment on the pleadings against some of the Plaintiffs’ claims, including the claim that challenged FDA’s statutory authority to approve the AquAdvantage® salmon production. Plaintiffs subsequently filed cross-motions in April 2019 in opposition to FDA’s motion for judgment on the pleadings and for summary judgment.

On December 19, 2019, the U.S. District Court sided with FDA and ruled that the agency had statutory authority to regulate AquaBounty’s GE salmon. The District Court held that it did not have jurisdiction to consider whether Guidance for Industry #187 interpretation of the FDCA was lawful because this guidance document was not a final agency action and thus could not be judicially reviewed.

The court nevertheless pointed out that the “foothold for the FDA’s assertion of authority” is found in the FDCA definition of “drug” under section 201(v), which states “article (other than food) intended to affect the structure or any function of the body of man or other animals.” Indeed, according to the guidance, “an rDNA construct in a GE animal that is intended to affect the structure or function of the body of a GE animal” is considered as a drug under the FDCA.

The District Court also found that FDA did have proper authority to regulate genetically engineered animals pursuant to the explicit language of the FDCA. In this respect, the court recognized that the AquAdvantage rDNA construct is a drug under the FDCA, reasoning that the rDNA construct cannot be considered as a food and is “intended to affect the structure and function” of the Atlantic salmon to stimulate growth. As a result, “the rDNA construct in this case is a ‘drug’ and (with an added layer of precision) a ‘new animal drug’ – that is, ‘any drug intended for use for animals other than man.’”

The District Court postponed its decision on whether the AquAdvantage salmon was dangerous to the environment and human health until a hearing set in May 2020.

The court finally concluded that “[p]erhaps 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.”

References:

AquaBounty Technology Official Website

Notice of Public Hearing; request for comments, Federal Register Vol. 75, No. 165 (August 26, 2010)

AquAdvantage Salmon Draft Environmental Assessment, FDA (May 4, 2012)

AquAdvantage Salmon Preliminary Finding of No Significant Impact, FDA (May 4, 2012)

AquAdvantage Salmon Final Environmental Assessment, FDA (November 12, 2015)

AquAdvantage Salmon Finding of No Significant Impact, FDA (November 12, 2015)

FDA AquAdvantage Salmon Approval Letter and Appendix

Consolidated Appropriations Act, 2016, 114^th Congress Public Law 113

“FDA Approves Application for AquaBounty Salmon Facility in Indiana,” (April 26, 2018)

FDA Commissioner Scott Gottlieb, M.D., on continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered salmon, FDA Statement (March 8, 2019)

Guidance for Industry # 187; Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs, Food and Drug Administration (June 2015)