In the Editor’s Column Volume 20, Issue 1 (2011), I wrote about genetically modified salmon under review by the US Food and Drug Administration (FDA) for potential use as human food. On 19 November 2015, the FDA announced it “approved AquaBounty Technologies’ application for AquAdvantage Salmon, an Atlantic salmon that reaches market size more quickly than non-genetically engineered (GE) farm-raised Atlantic salmon.”
The FDA claimed its regulatory authority for this action under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act for GE animals. The FDA concluded that the recombinant DNA (rDNA) construct that was introduced into the animal meets the definition of a drug. The FD&C Act defines drugs, in part, by their intended use as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [US FD&C Act, Chapter 9, Sub-Chapter II, Section 321(g)(1)(C)]. In this case, the rDNA construct introduces a trait that makes the AquAdvantage Salmon grow faster.
Based on comprehensive analysis of the scientific data presented by AquaBounty Technologies, the FDA determined that AquAdvantage Salmon meets the statutory requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act. Among the requirements the marine biotechnology-based company had to show were: food from the fish is safe to eat; the drug (rDNA) did not harm the animal; AquAdvantage Salmon meets the claim of a faster growth rate; and that there was no difference in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon.
One of the more interesting requirements was to show not only no nutritional differences exist between GE farm-raised Atlantic salmon and other farm-raised Atlantic salmon but no new allergens (proteins) were present. The scientific data simply showed there was no sound scientific evidence to decline the application based on food safety requirements and meeting the intended use of the animal drug (rDNA).
There are many other environmental and social issues of concern regarding use of GE animals. In the production of AquAdvantage Salmon, specific control measures are also required. This includes raising the AquAdvantage Salmon in land-based, contained hatchery tanks in two specific facilities in Canada and Panama. The FDA approval does not allow AquAdvantage Salmon to be bred or raised in the United States. This is the case even though an environmental assessment required under the National Environmental Policy Act found no significant environmental impact because of the multiple and redundant measures taken to contain the fish, prevent escape of eggs and fish, and unlikely establishment of fish in the wild. AquAdvantage Salmon are reproductively sterile (triploid at greater than 99%).
Based on sound science and a comprehensive review, the FDA is taking steps regarding food from GE plants and animals and will issue guidance documents for manufacturers who wish to voluntarily label their products as containing ingredients from GE or non-GE sources. Because the data and information evaluated show that AquAdvantage Salmon is not materially different from other Atlantic salmon, the FDA has determined that no additional labeling of food from AquAdvantage Salmon is required.
Draft guidance on labeling foods derived from Atlantic salmon and a final guidance on foods derived from GE plants will be published. The agency accepted public comment for 60 days on Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived from Genetically Engineered Atlantic Salmon. The comment period ended 25 January 2016.
Whether we agree with the FDA’s decision or not, the first approval for a genetically engineered animal intended for food has been given. Now we will see if consumers will accept the GE farm-raised Atlantic salmon and whether or not the industry will support the science necessary to open the market for other GE animal products.