Three U.S. consumer groups petitioned the Food and Drug Administration on Tuesday to subject a new genetically engineered salmon to a more rigorous review process than is now in place before the fish can be approved as safe to eat.
The fish at issue, AquaBounty Technologies’ AquAdvantage salmon, is currently classified as a new animal drug for the purposes of FDA review.
The FDA considers any genetically altered animal a new animal drug for approval purposes. The petition calls for the salmon to be classified as a food additive instead, which would require a more rigorous FDA review.
AquaBounty is seeking U.S. approval to market its engineered Atlantic salmon, which contains a gene from another fish species, the Chinook salmon, to help it grow twice as fast as normal.
The consumer groups’ petition says the way these salmon are created substantially alters their composition and nutritional value, and so they should be treated as a food additive. Under this standard, they said, the company’s data would have to overwhelmingly prove AquAdvantage salmon are safe to eat.
The consumer groups – Food & Water Watch, Consumers Union, and the Center for Food Safety – said in a statement the “new animal drug” designation is insufficient to protect public health. The review process for food additives offers greater protection, they said.
AquaBounty had no comment on the petition.
The FDA did not comment specifically on the petition, but confirmed that the company’s application for FDA approval for AquAdvantage salmon is under review, and that genetically engineered animals are evaluated under the new animal drug provisions of U.S. law.
So, I got this new animal drug with fins, scales and swims around? And I thought environmental regulations were idiotic. What are these so-called consumer groups after? Reduced food supplies?
FDA’s Food Additive personnel looked at preliminary data on this (or possibly a similar fish) long before submission under Animal Drug provisions. Most likely we would have classified it as GRAS on the basis of information submitted. Changes in composition and nutritional value (as minor as these would be) shouldn’t trigger review as a food additive, where the emphasis is on safety and technical effects.
T. Brown