November 19, 2015 - Based on sound science and a comprehensive review, the U.S. Food and Drug Administration is taking several important steps today regarding food from genetically engineered (GE) plants and animals, including the first approval for a genetically engineered animal intended for food, AquAdvantage Salmon. The agency is also issuing two guidances for manufacturers who wish to voluntarily label their products as containing ingredients from GE or non-GE sources: a draft guidance on labeling foods derived from Atlantic salmon, and a final guidance on foods derived from GE plants.
FDA approves application for AquAdvantage Salmon
The FDA has approved AquaBounty Technologies’ application for AquAdvantage Salmon, an Atlantic salmon that reaches market size more quickly than non-GE farm-raised Atlantic salmon. The FDA regulates GE animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act, because the recombinant DNA (rDNA) construct introduced into the animal meets the definition of a drug. In this case, the rDNA construct introduces a trait that makes the AquAdvantage Salmon grow faster.
“The FDA has thoroughly analyzed and evaluated the data and information submitted by AquaBounty Technologies regarding AquAdvantage Salmon and determined that they have met the regulatory requirements for approval, including that food from the fish is safe to eat,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine.
Based on a comprehensive analysis of the scientific evidence, 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 sponsor had to meet are that food from the fish is safe to eat; the rDNA construct (the piece of DNA that makes the salmon grow faster) is safe for the fish itself; and the AquAdvantage Salmon meets the sponsor’s claim about faster growth. In addition, the FDA determined that food from AquAdvantage Salmon is as safe to eat and as nutritious as food from other non-GE Atlantic salmon and that there are no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon.
The AquAdvantage Salmon may be raised only in land-based, contained hatchery tanks in two specific facilities in Canada and Panama. The approval does not allow AquAdvantage Salmon to be bred or raised in the United States. In fact, under this approval, no other facilities or locations, in the United States or elsewhere, are authorized for breeding or raising AquAdvantage Salmon that are intended for marketing as food to U.S. consumers. As required by the National Environmental Policy Act, the FDA completed an environmental assessment to determine whether approval of the application would result in significant effects on the quality of the human environment in the United States. The FDA has determined that the approval of the AquAdvantage Salmon application would not have a significant environmental impact because of the multiple and redundant measures being taken to contain the fish and prevent their escape and establishment in the environment.
These measures include a series of multiple and redundant levels of physical barriers placed in the tanks and in the plumbing that carries water out of the facilities to prevent the escape of eggs and fish. Finally, the AquAdvantage Salmon are reproductively sterile so that even in the highly unlikely event of an escape, they would be unable to interbreed or establish populations in the wild.
The FDA will maintain regulatory oversight over the production and facilities, and will conduct inspections to confirm that adequate physical containment measures remain in place. In addition, the Canadian and Panamanian governments will also be conducting inspections of the facilities.
The FDA held a Veterinary Medicine Advisory Committee meeting on the sufficiency of the scientific review and a hearing to gather opinions on labeling of food from AquAdvantage Salmon. The agency received and reviewed comments from these two meetings. In addition, the agency released a draft environmental assessment and preliminary finding of no significant impact for public comment; these comments were also reviewed prior to the agency’s final decision.
Agency publishes guidances on voluntary labeling of food from genetically engineered sources
The FDA’s responsibility is to ensure that foods under its purview meet applicable safety, labeling, and other statutory and regulatory requirements. Foods derived from GE plants and animals must meet the same requirements, including safety and labeling requirements, as other foods. Under the Federal Food, Drug, and Cosmetic Act, the FDA can only require additional labeling of foods derived from GE sources if there is a material difference – such as a different nutritional profile – between the GE product and its non-GE counterpart. In the case of the AquAdvantage Salmon, the FDA did not find any such differences.
“We recognize that some consumers are interested in knowing whether food ingredients are derived from GE sources,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “The FDA is issuing two guidance documents that explain how food companies that want to voluntarily label their products can provide this information to consumers.”
These two guidance documents include a draft guidance on voluntary labeling indicating whether food has or has not been derived from GE Atlantic salmon, and a final guidance on voluntary labeling indicating whether food has or has not been derived from GE plants.
Although companies can always voluntarily add labeling to their products as long as it’s truthful and not misleading, these guidances provide recommended actions for manufacturers who may wish to voluntarily label their products with information about whether the foods contain ingredients from GE sources.
The agency is accepting public comment for 60 days starting on November 23 via instructions in the Federal Register on Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived from Genetically Engineered Atlantic Salmon.
How to Comment on the Draft Guidance
To comment on the draft guidance on voluntary labeling indicating whether food has or has not been derived from GE Atlantic salmon:
- Read the Draft Guidance.
- Starting Monday, November 23, submit comments on the draft guidance on Regulations.gov.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety and effectiveness of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety of our nation’s food supply, cosmetics, dietary supplements, and products that give off electronic radiation, and for regulating tobacco products.
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