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Tuesday, December 1, 2015

FDA Approves Genetically Engineered Salmon

Wow, this is a big story we covered this week on our main site at Renewable  For the first time not plant/seed related, the FDA approves GM on an animal.  As asked in the story, does this open the floodgates on a steady diet of genetically modified food for consumers?

Some states, including VT and others who interviewed with us, require labeling on GMO sourced food.  Others are contemplating banning those foods completely.  Is that the right answer?

This is a monster sea change.  How we eat will never be the same.  And, who knows what new versions of plants and animals we unleash on the world.  Needless to say we'll follow this closely on the blog and radio show.

Feel free to send us your comments:

re the flood gates about to be opened when it comes to genetically engineered (GE) foods?

On November 19, 2015, the U.S. Food and Drug Administration, based on sound science and a comprehensive review, is taking several important steps regarding food from genetically engineered (GE) plants and animals, including the first approval for a genetically engineered animal intended for food, AquAdvantage Salmon, AKA AquaBounty Technologies. 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for manufacturers who wish to voluntarily label their products as containing ingredients from GE or non-GE sources: a draft guidance on labeling foods derived from Atlantic salmon, and a final guidance on foods derived from GE plants.

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.

The volunteer labeling question is quite interesting considering the push for GMO labeling. Are they one in same by those pushing for GMO labeling, or are they different? Science says they’re different, should the labeling also be uniquely different?
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