Regulatory Brief

 Approval and Labeling of Food Made from AquAdvantage Salmon


Formal title: Docket Number [FDA-2010-N0385] Food Labeling: Labeling of Food Made From AquAdvantage Salmon; Public Hearing and Request for Comments


Brief Description:

The Food and Drug Administration (FDA) announced a public hearing regarding the labeling of food derived from AquAdvantage Salmon, a genetically engineered Atlantic salmon. The purpose of the hearing was for FDA to explain the relevant legal principles for food labeling and to solicit information and views from interested persons on the application of these principles to the labeling of food derived from AquAdvantage Salmon. The FDA also announced that it will hold a public Veterinary Medicine Advisory Committee (VMAC) meeting.

AVMA Response:

The AVMA recognizes the importance and value of genetic engineered biotechnology. The AVMA believes that the creation of new genetic-based knowledge through basic genetic research and the practical application of the technology should not be needlessly restricted, so long as it does not negatively impact the integrity of the environment and/or the general health and welfare of the genetically modified animals, and meets human values and needs. To that end the AVMA strongly supports a science-based regulatory policy for the approval of products developed through biotechnology and regulations that require evaluation of product safety and efficacy by U.S. Department of Agriculture (USDA), the FDA, the Environmental Protection Agency (EPA), or other appropriate government agencies, before they can be marketed for the intended uses. All evaluations should be solidly based on sound science and meaningful risk assessments.

In regards to the labeling of food made from AquAdvantage salmon, the FDA has clearly reiterated the five key legal principles for labeling of foods from genetically engineered animals. Specifically that the law prohibits food labeling that is false or misleading, but allows voluntary labeling about production methods, so long as the labeling is not false or misleading. The law also requires that the label include a name that accurately describes the basic nature of the food and that FDA cannot require additional labeling about production methods unless it is necessary to ensure that the labeling is not false or misleading. As eloquently expressed by FDA in recent hearings concerning AquAdvantage salmon, "FDA cannot require labeling based on differences in the production process if the resulting products are not materially different due solely to the production process."

Unfortunately, lack of public understanding that the DNA constructs used in AquAdvantage salmon are not unique has created a public misunderstanding that these DNA constructs are a food safety concern and a public demand that products from these salmon be labeled accordingly. However, these DNA constructs originate from Coho salmon and ocean pout that have been consumed by the public for a very long time. If FDA were to require labeling, because of this public misunderstanding, it would de facto constitute misleading labeling. Furthermore, if FDA were to require labeling of AquAdvantage seafood, and many food products that will inevitably be manufactured from these fish, the FDA would have to retroactively require similar labeling for a huge number of products that have been marketed for the last several decades made from genetically engineered corn and soybeans. Clearly this is infeasible and unrealistic.

Consequently, unless FDA can determine there is a food safety or other hazard that fits the constraints of the law, the agency should not require labeling of these genetically engineered products.

Background Documents:

View August 26, 2010 Federal Register document regarding September 19-20, 2010 VMAC Meeting (PDF)

Background Document: The VMAC Meeting on Science-Based Issues Associated with AquAdvantage Salmon (PDF)

Briefing Packet for AquAdvantage Salmon VMAC (PDF)

Environmental Assessment for AquAdvantage Salmon (Aqua Bounty Technologies, Inc.) (PDF)

View August 26, 2010 Federal Register document regarding Public Hearing on Labeling of Food Made from AquAdvantage Salmon (PDF)

Public Hearing on the Labeling of Food Made from the AquAdvantage Salmon (PDF)

FDA's Final Guidance on Regulating Genetically Engineered Animals (PDF)

CVM Guidance for Industry #187 – Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (PDF)

Status:

The AVMA responded on November 22, 2010. (PDF)