Food & Water Watch filed two legal petitions asking the FDA to evaluate AquaBounty’s (ABTX) genetically engineered salmon as a “food additive,” instead of as an animal drug, and to declare GMO salmon unsafe to eat based on the food additive review process.
“It couldn’t be more clear to consumers that GMO salmon is a food, not a drug,” said Wenonah Hauter, Executive Director of Food & Water Watch. “It’s also clear that there are serious food safety concerns with this fish and major scientific gaps in FDA’s animal drug risk assessment. It’s time for FDA to step up and protect the health and welfare of American citizens rather than the economic interests of the biotechnology industry.”
Food & Water Watch’s identical petitions filed with the FDA — one citizen petition and one food additive petition — both argue that FDA’s current animal drug review process is insufficient to protect public health, and that the agency is required by law to review GMO salmon under what should be a more rigorous food additive review process. As a food additive, GMO salmon would be presumed unsafe unless it undergoes comprehensive toxicological studies to ensure that it is safe to consume and properly labeled.
Food & Water Watch filed a similar petition in 2012, but the FDA refused to review it. The newly filed petitions include new data showing major weaknesses with FDA’s review of hormone levels and potential allergens in GMO salmon, both of which appear highly elevated. In the allergy study that FDA examined, AquaBounty only examined six GMO salmon, which showed a 20 to 50 percent increased allergenic potency.
“The agency needs to seriously evaluate this petition, as it supports what consumers, scientists, grocery retailers and even the commercial salmon industry have been saying all along: GMO salmon is totally unnecessary and highly risky,” said Hauter.
If approved, AquaBounty’s GMO salmon would be the first biotech animal ever to enter the food supply anywhere in the world. Many scientists have noted major weaknesses in the FDA’s review of food safety concerns.
“For an agency responsible for 80 percent of the food that we eat—and which often touts its commitment to science-based regulations—the FDA is shockingly lenient with the quality of science it is requiring of AquaBounty,” Hauter said. “We can’t make science-based risk assessments based on six fish. And we can’t declare that GMO salmon is safe to eat based on a regulatory review process that treats a food product like a drug. The only appropriate course of action for FDA is to evaluate GMO salmon as a food and declare it unsafe.”