The fish, developed by Massachusetts-based AquaBounty Technologies, is Atlantic salmon given the growth hormone gene of the faster-growing Pacific salmon, along with DNA from the eel-like ocean pout. The company claims that the resulting AquAvantage salmon reaches maturity at twice the rate of normal Atlantic salmon, and requires 25 percent less food.
This is the first time that the Food and Drug Administration (FDA) has considered the safety of genetic engineering in animals intended for human consumption, and it has no specific framework for doing so. Therefore the GE process is being assessed by its Veterinary Medicine Advisory Committee through its new animal drug approval procedure.
The letter to Hamburg claims that the FDA is using an inappropriate process to assess the salmon’s safety and asks the agency to “halt all proceedings”, saying that potential human health and environmental impacts have not been fully or openly reviewed.
“One of the most serious concerns regarding AquaBounty’s application is the FDA has no adequate process to review a GE animal intended as a human food product,” the letter said.
“FDA is considering this GE fish through its process for reviewing a new drug to be used by animals, not for creation of a new animal, especially one intended for human consumption. Clearly, this is inappropriate.”
The letter’s signatories said that instead the Center for Food Safety and Applied Nutrition should assess the possible human health implications of AquaBounty’s salmon.
The safety of the AquAvantage salmon was the subject of two days of hearings this month, which pitted AquaBounty against consumer and environmental campaigners. But the FDA’s Veterinary Medicine Advisory Committee (VMAC) did not vote or make a recommendation at the end of the hearings, saying that it does not yet have sufficient data.
The lawmakers who signed the letter to the FDA were Sen. Begich (D-AK), Sen. Lisa Murkowski (R-AK), Sen. Patty Murray (D-WA), Sen. Bernard Sanders (D-VT), Sen. Maria Cantwell (D-WA), Sen. Ron Wyden (D-OR), Sen. Patrick Leahy (D-VT), Sen. Kirsten Gillibrand (D-NY), Sen. Barbara Mikulski (D-MD), Sen. Jeff Merkley (D-OR), and Sen. Jon Tester (D-MT).
In a parallel move, Congressmen Peter DeFazio (D-OR), Dennis Kucinich (D-OH), and Mike Thompson (D-CA) led 24 members of the House of Representatives in signing a similar letter to Hamburg asking the FDA to halt the approval process.