(Beyond Pesticides, February 9, 2012) Consumer groups submitted a formal petition on Tuesday asking the Food and Drug Administration (FDA) to classify and evaluate AquaBounty’s “AquAdvantage” genetically engineered (GE) salmon and all of its components as a food additive. Currently FDA’s review process classifies the GE salmon as a new animal drug, which the petitioners find insufficient to protect public health. The groups, Center for Food Safety, Food & Water Watch, and Consumers Union say that the agency is required by law to review the GE salmon under a more rigorous process for food additives which offers greater protection. The AquAdvantage salmon would be the first GE animal meant for human consumption.
“The data FDA has on GE salmon, which were supplied by Aquabounty, are incomplete, biased, and cannot be relied upon to show that the GE salmon is safe to consume,” said Food & Water Watch Executive Director Wenonah Hauter. “Aquabounty’s own study showed that GE salmon may contain increased levels of IGF-1, a hormone that helps accelerate the growth of the transgenic fish and is linked to breast, colon, prostate, and lung cancer.”
The potential health risks of GE salmon, the groups warn, are no different from a number of food additives that FDA has banned in the past, including those that are cancer causing.
“FDA’s choice to allow the first proposed transgenic animal for food to somehow only be review as a drug is contrary to law, science and common sense,” said George Kimbrell, Senior Attorney for the Center for Food Safety. “Public health and transparency should be championed, not skirted, particularly when contemplating such an unprecedented approval.”
In order to create the transgenic fish, Aquabounty genetically engineered an Atlantic salmon by inserting a Chinook salmon growth-hormone gene, as well as a gene sequence from an ocean pout. The company claims this engineering causes the GE salmon to undergo an increase in growth rate that allows the fish to reach market size in half the normal time.
Aquabounty has submitted an application to FDA for approval of the transgenic salmon under the new animal drug provisions of the Federal Food, Drug and Cosmetic Act. Members of the FDA’s own advisory committee have described the agency’s review of the GE salmon under this process as lacking in rigor.
The consumer groups’ petition asserts that the process used to create the GE salmon substantially alters its composition””including its nutrition value””and demand that the fish and its components be treated as a food additive pursuant to FDA’s guidelines. As a food additive, AquaBounty’s GE salmon would be considered unsafe for consumption unless the company’s data overwhelmingly proved otherwise.
“If FDA actually evaluated GE salmon as a food additive, including allergy-causing potential, they would not likely be able to approve it because of the health risks that have can already be seen in an incomplete set of data.” said Michael Hansen, Senior Scientist with Consumers Union.
The groups assert that a proper review process would require GE salmon to undergo comprehensive toxicological studies, specifically those developed to ensure that foods entering the market are safe to consume and are properly labeled.