Legal counsel for the coalition is being provided by the Center for Food Safety and Earthjustice. They are challenging the FDA’s claim that it has the authority to approve and regulate GE animals as “animal drugs” under the 1938 federal Food, Drug and Cosmetic Act.
EcoWatch quotes lawyer, George Kimbrell, senior attorney for the Center for Food Safety and co-counsel for the plaintiffs, who said, “FDA’s decision is as unlawful as it is irresponsible. This case is about protecting our fisheries and ocean ecosystems from the foreseeable harms of the first-ever GE fish, harms FDA refused to even consider, let alone prevent. But it’s also about the future of our food: FDA should not, and cannot, responsibly regulate this GE animal, nor any future GE animals, by treating them as drugs under a 1938 law.”
And, yes, it is true. The FDA probably couldn’t figure out where to place genetically engineered salmon, so it stuck them into the regulations as an “animal drug.” So what is the active ingredient in this AquaBounty drug? It is called opAFP-GHc2 rDNA construct. And despite opposition from the public, the FDA approved the fish for human consumption in November 2015.
The provisions of the 1938 federal Food, Drug, and Cosmetic Act were meant to ensure the safety of veterinary drugs used to treat diseases in livestock. There is no provision written that in any way describes genetically engineered food products made for human consumption. This fact, in itself, makes the FDA ruling on the AquaBounty fish illegal.
AquaBounty’s salmon are actually man-made fish, to put it bluntly. The genetically engineered salmon was created by using the DNA from three fish: Atlantic salmon, Pacific king salmon, and the Arctic ocean eelpout.
The lawsuit also alleges the FDA did not take into consideration the environmental impact the GE salmon would have on the environment as well as fishing communities. Even though the FDA says the GE salmon cannot reproduce in the wild, there are no confirmed studies to back the claim, and the disregard for the GE salmon’s impact on wild populations is reckless on the FDA’s part.
“It’s clear that the market has rejected GE salmon despite FDA’s reckless approval,” Dana Perls, food and technology campaigner for Friends of the Earth, said. “Major retailers including Costco, Safeway, and Kroger won’t sell it and polls show the vast majority of people don’t want to eat it. Yet under this approval it won’t be labeled, violating our fundamental right to know what we are feeding our families.”
Labeling is another issue with the lawsuit. The FDA opted to make labeling voluntary, but this action was foiled when in December’s congressional spending bill, according to EcoWatch, Alaska Sen. Lisa Murkowski successfully included a provision that directed the FDA to provide a label for the genetically engineered salmon. Now the agency must act in accordance with the directive to develop a label to better inform consumers about the product they are purchasing.
Basically, the FDA went off half-cocked and decided on its own to approve a product that just about everyone, from other federal agencies to environmental groups and millions of citizens did not want. This is not the way a federal agency is supposed to be protecting the health and welfare of the public.