“Frankenfish”, “GMO Salmon” or “GE Atlantic Salmon” has been making headlines these past few months as AquaBounty prepares for the first harvest from its fishery in Albany, Indiana. However, a federal judge in the Northern District of California recently issued an order requiring the U.S. Food and Drug Administration (FDA) to reexamine the environmental impacts of allowing the production of genetically engineered salmon on wild salmon. Below is an overview of the decision, some of the food safety and labeling issues in the United States, as well as a brief overview of how Canada has approached regulation of genetically engineered Atlantic salmon.

AquaBounty and AquAdvantage

Genetically engineered Atlantic salmon was developed by the company AquaBounty in 1989. The company refers to the salmon as AquAdvantage Atlantic Salmon (AquAdvantage). According to the FDA’s website, AquAdvantage is able to grow at a faster rate than non-genetically engineered salmon because “it contains an rDNA construct that is composed of the growth hormone gene from Chinook salmon under the control of a promoter (a sequence of DNA that turns on the expression of a gene) from ocean pout (another type of fish).” AquaBounty has facilities in Canada, Panama, and potentially two facilities in the US, one currently in operation in Indiana and the other potentially in Kentucky. All of the AquaBounty facilities are enclosed and on land in an effort to mitigate the risk of AquAdvantage escaping into the ocean.

Recent Decision in Institute for Fisheries Resources et al. v. Stephen Hahn et al.

AquaBounty currently has numerous mitigation efforts in place to stop AquaAdvantage salmon from reaching the ocean. However, plaintiffs in Institute for Fisheries Resources, felt that they were not enough, arguing that the FDA had not done any analysis on what would happen if the GE Atlantic salmon was able to reach the ocean. The court agreed, concluding that because the FDA did not conduct an analysis of “what might happen to normal salmon in the event the engineered salmon did survive and establish themselves in the wild,” the FDA had violated the National Environmental Policy Act (NEPA) in approving the original application for the AquAdvantage facilities in Canada and Panama.[1]. While plaintiffs won summary judgment on three of the eight remaining claims, the case was “remanded to the FDA without vacatur for reconsideration of the environmental assessment under NEPA and the ESA analysis in compliance with this ruling.” Which is to say, the opinion orders the FDA to reanalyze the issues surrounding circumstances where the salmon escape and are able to survive and thrive in the wild. However, this order leaves the approvals of AquAdvantage and the facilities in Canada, Panama, and Indiana in place. This means, AquAdvantage could still be sold in the US as projected later this year. In fact, in response to the court’s order, AquaBounty CEO, Sylvia Wulf stated in an emailed statement, “The focus of this decision was on the potential environmental impacts, and the judge confirmed the ‘low’ threat to the environment of our salmon . . . [t]his decision will not have an impact on our on-going operations on Prince Edward Island, Canada to produce eggs or in the raising and selling of AquAdvantage salmon from our farm in (Albany) Indiana. We are committed to working with FDA on next steps and continue to evaluate the legal decision.”[2] With this in mind, the next questions concern the measures that have been taken to ensure GE Atlantic salmon is safe to eat, how consumers will know that the salmon in their stores is genetically engineered, and how other countries are regulating this product.

Food Safety

In 2015, the FDA approved AquAdvantage as a veterinary drug prompting the initial complaint in the above discussed case, Institute for Fisheries Resources. Part of the plaintiffs’ argument was that FDA did not have the statutory authority to regulate GE animals as a “new animal drug.” In December of 2019, the court found that the FDA had the authority to regulate GE Atlantic salmon as an animal drug. Specifically, the court stated that “[u]nder the plain language of the Food, Drug and Cosmetic Act (FD&C), the FDA has the authority to require companies to seek its approval before creating and breeding genetically engineered animals” noting that the statutory definition of a “drug” is much broader than its colloquial definition. A “drug” is defined in part as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”[3] The court further reasoned, and FDA later released guidance stating that “altered genomic DNA in an animal is a drug within the meaning of section 201(g) of the FD&C Act because such altered DNA is an article intended to affect the structure or function of the body of the animal, and, in some cases, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in the animal.” Therefore, based on the court’s decision and the FDA guidance, GE Atlantic salmon, which contain rDNA construct composed of the growth hormone gene from Chinook salmon under the control of a promoter from ocean pout, are regulated as an animal drug.

The NADA is a formal process in which AquaBounty asked the FDA’s Center for Veterinary Medicine (CVM) to approve GE Atlantic salmon as safe and effective. The CVM reviewed AquaBounty’s application and found that AquAdvantage was as safe to eat as non-GE Atlantic salmon and that the nutritional profiles of the two types of salmon were comparable. The evaluation itself consisted of public meetings, public comments and public review of draft environmental documents. On a more scientific level, the CVM compared AquAdvantage to non-GE farm-raised Atlantic salmon grown by both AquaBounty and a different commercial farm. CVM’s research compared several key hormones in each of the three categories of salmon finding no biologically relevant differences. As a result, AquAdvantage Atlantic salmon was approved with strict requirements regarding containment of the GE Atlantic salmon. For more on the environmental issues surrounding AquAdvantage, please see Staff Attorney Brigit Rollins’s blog post that provides an overview of the alleged NEPA violations in Institute for Fisheries Research.

Labeling Requirements

Throughout the NADA process and after, the question of how GE Atlantic salmon would be labeled has been a highly debated issue. One of the main issues is the interplay between the United States Department of Agriculture (USDA) and FDA in labeling foods that have been created through in vitro nucleic acid techniques, including the rDNA injection used in the creation of AquAdvantage. The FDA released guidance in 2015 that does not require any labeling requirements for GE Atlantic salmon because it is not materially different from other Atlantic salmon and meets the regulatory standard for Atlantic Salmon. Therefore, AquAdvantage products can be labeled as “Atlantic Salmon” under the FD&C Act. However, in FDA’s guidance, the agency states that it supports voluntary labeling of non-genetically engineered products while cautioning against deceptive mislabeling products. As a result of FDA’s decision regarding labeling, language was added to the 2016 federal budget requiring labeling for GE Atlantic salmon before it could be imported into the US. This back and forth on the labeling requirements caused many issues for AquaBounty as its grow out facility was located in Indiana while the eggs were cultivated in Canada. The import alert blocked AquaBounty from bringing its eggs to the Indiana facility for growing.

In December of 2018, the USDA passed the National Bioengineered Food Disclosure Standard (NBFDS). This USDA-developed standard regulates the labeling of foods that are genetically engineered, including GE Atlantic salmon. After the passage of this standard, the import alert on GE Atlantic Salmon was lifted in March of 2019 allowing AquaBounty to import AquAdvantage eggs from the Canadian facility to the facility in Indiana. According to the NBFDS, a bioengineered food, “contain[s] detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in nature.” USDA maintains the List of Bioengineered Foods which includes AquAdvantage Atlantic salmon. Therefore, products that contain AquAdvantage must be appropriately labeled under the NBFDS as bioengineered with one of the four disclosure options: on-package text stating “bioengineered food”; the USDA approved symbol for bioengineered food; an electronic or digital link, such as a QR code; or a text message disclosure prompt.[4]

Canadian Regulations

Yet another wrinkle in this complex issue is the fact that AquAdvantage has been sold in Canada for several years. Canada refers to bioengineered foods as Genetically Engineered (GE). For a GE food product to be approved for market access in Canada, companies must engage in extensive research to ensure the product is safe and nutritious, and submit an application for market access to the Canadian government. This application and accompanying research were reviewed by Health Canada, the Canadian Food Inspection Agency and Environment and Climate Change Canada to assess AquAdvantage’s safety and nutrition for use as food and livestock feed, and the risk to the environment.

In 2016 Canada approved AquAdvantage for market access. However, contrary to the United States, Canada does not require disclosure that AquAdvantage is genetically engineered. Instead, Canada has developed a national standard for Voluntary Labelling and Advertising of Foods that Are and Are Not Products of Genetic Engineering. Under this standard, labeling of foods as GE or non-GE is up to companies in accordance with the standards.

Moving Forward

While many consumers are wary of consuming genetically engineered Atlantic salmon, the labeling requirements of the Bioengineered Foods Disclosure Standard ensure that consumers are aware of what they are purchasing through USDA approved on-package labeling. FDA will be reassessing parts of its environmental analysis in the coming months in accordance with the court’s order. However, in the mean time AquaBounty is able to continue its operations as planned.

To read the court’s opinion and order, click here.

For more information regarding FDA’s review and approval of AquAdvantage and labeling, click here.

For more information on Canada’s GE Atlantic Salmon regulations, click here.

To view the FDA approval letter and supporting documents for AquAdvantage, click here.

To view the FDA’s Guidance on GE Atlantic Salmon labeling, click here.

[1] Inst. for Fisheries Res., et al., Plaintiffs, v. United States Food & Drug Admin., et al., Defendants., No. 16-CV-01574-VC, 2020 WL 6495656 at *1 (N.D. Cal. Nov. 5, 2020)

[2] Hill, Sam, Federal Judge Rules FDA Must Revaluate Effects of Potential GE Salmon Escape, Seafood Source (November 16, 2020) https://www.seafoodsource.com/news/food-safety-health/federal-judge-rules-fda-must-reevaluate-effects-of-potential-ge-salmon-escape

[3] 21 U.S.C. § 321

[4] National Bioengineered Food Disclosure Standard Fact Sheet, USDA Agricultural Marketing Service (November 17, 2020) https://www.ams.usda.gov/sites/default/files/media/BEFactSheet.pdf