Genetically Engineered Salmon Need Not Be Labeled

WASHINGTON, D.C. (Monday, November 22, 2010) - As part of the U.S. Food and Drug Administration (FDA) rigorous, scientific regulatory review governing genetically engineered (GE) animal technologies, the Biotechnology Industry Organization (BIO) has submitted comments on the “Labeling of Food Made From AquAdvantage Salmon.”

The AquAdvantage Salmon is genetically engineered to reach its market weight in half the time of conventionally raised salmon thus contributing to more sustainable aquaculture systems.  It was developed by Massachusetts-based AquaBounty Technologies, a BIO member.

“FDA is the world leader in science-based reviews of products benefiting human and animal health, and we’re seeing that process at work in the consideration of the AquAdvantage salmon,” said Dr. David Edwards, BIO’s director of animal biotechnology.  “Part of that process calls for looking at whether or not this product needs to be labeled if it were to be approved.  According to FDA’s existing food labeling policy, the answer should be ‘no’.”

The FDA’s Veterinary Medicine Advisory Committee (VMAC) held a series of meetings September 19-21 where it heard from independent experts about the salmon’s safety, efficacy, and environmental benefits.  At that time, FDA also began a 60-day public comment period to hear from interested parties on how food labeling laws and principles should apply to the AquAdvantage salmon.

In its comments, BIO reiterates its strong support for FDA’s science-based labeling requirements that apply to all foods.  These requirements include:

• No special label is required if a new food is substantially equivalent to its traditional counterpart in terms of safety, nutrition, taste, appearance, smell, and preparation methods.
• A label is required if the food is materially different from its traditional counterpart in nutritional or safety attributes, taste, appearance or smell, or in how its preparation methods may differ.
• Voluntary claims are allowed on food labels provided such labels are truthful, do not mislead consumers and are verifiable. 

“Salmon grown from AquAdvantage eggs are nutritionally and biologically the same as any other Atlantic salmon, so it is substantially equivalent,” said Edwards. “There is no reason for it to be labeled as different.”

The first U.S. approval for a GE animal product came in February 2009 when the FDA approved ATryn^®, a therapeutic protein derived from the milk of goats genetically engineered to produce recombinant antithrombin. BIO is hopeful that, as the FDA considers its first genetically engineered food animal, the process will pave the way for future technologies currently in the pipeline.

“The application of technology to animal agriculture is not something that is new.  It has allowed us to produce food and fiber more efficiently and sustainably for a growing population,” said Edwards. “GE animals have already realized the promise of advancing human health, and now this technology could lead to more sustainable and environmentally friendly food production.”

For More Information

• BIO’s comments to the FDA are posted at http://bio.org/foodag/action/20101119.pdf
• FDA's nalysis and other summary documents related to the AquAdvantage  Salmon are posted here:  http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM224762.pdf
• Visit AquaBounty’s Pressroom to get more information on the AquAdvantage Salmon:  http://www.aquabounty.com/PressRoom/
• Visit BIO’s Online GE Animal Resource Center at http://bio.org/foodag/animal_biotech/#genetic. 

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About BIO

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIO produces BIOtech Now, an online portal and monthly newsletter chronicling “innovations transforming our world.” Subscribe to BIOtech Now.

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