This blog was originally published on November 30, 2015. It now contains recent updates.
UPDATE | Pending Litigation
The Center for Food Safety and a coalition of environmental and consumer advocacy groups filed a lawsuit against the Food and Drug Administration— disputing their November approval of AquaBounty’s GE salmon. The lawsuit, filed back in March, challenges the FDA’s authority to regulate genetically modified animals as “animal drugs” under the Federal Food, Drug and Cosmetic Act established in 1938.
This is a prime example of how outdated policies are being bent to regulate the relatively new technology of genetic engineering. The Federal Food, Drug and Cosmetic Act was originally written to assure the safety of veterinary drugs used to treat disease in livestock, not to address entirely new GE animals. This approval sets a precedent for a whole range of genetically engineered animals to enter our food system—emphasizing the immense need for updating our current regulatory framework for addressing genetically modified organisms.
UPDATE | Canada Weighs in
On May 19th, Health Canada followed the US Food and Drug Administration’s hasty lead and approved AquaBounty’s GE salmon for human consumption in Canada. Canadian officials have approved the GMO salmon without public consultation and with no plans to require any special labeling. This decision comes despite widespread public outcry from concerned citizens, environmental and consumer advocacy groups in both the US and Canada.
“GM salmon production threatens the future of wild Atlantic salmon,” Calinda Brown of the Ecology Action Centre said. “Retailers can protect consumers and the environment by making sure this GM fish never makes it to grocery store shelves.”
The AquaBounty salmon is still over a year away from hitting the marketplace – and even then, in limited quantities. With over 60 major grocery chains refusing to carry the salmon and growing opposition from consumers, it is likely this genetically engineered fish will be a big flop at the supermarket.
– Original post –
On November 19th the Food and Drug Administration made US history—for the first time ever a genetically modified animal has been approved for human consumption. The FDA effectively ended a long struggle for AquaBounty Technologies who had been seeking approval for its AquAdvantage salmon since the 1990s. The AquAdvantage salmon is genetically engineered to reach market size twice as fast as conventional, farmed Atlantic salmon. Not only does this new salmon contain a growth hormone from Chinook salmon, but it also contains a gene from a completely different species—the ocean pout—which allows the new growth hormone to remain active year round.
Genetically engineered animals are regulated by the FDA as veterinary drugs. The FDA oversees these organisms with the logic that an inserted gene meets the definition of a drug. This outdated policy is being forced to apply to new technologies and the food in our grocery carts.
Going Against the Current
The issue has been hotly contested. More than 40 congressmen, 300 environmental, consumer, salmon and fishing groups and associations, and 2 million individuals all voiced their opposition to the GMO salmon. So why did the approval come now? The FDA claims the process took so much time due to the fact this was the first decision of its kind—one that will surely set a precedent—and one where public safety and concern falls by the wayside.
“The FDA’s approval of GMO salmon is irresponsible and dangerous. We hope, with ongoing consumer awareness, that the genetically engineered salmon will be removed from the marketplace.” Megan Westgate, Executive Director, Non-GMO Project
What makes this situation most concerning is that the FDA has failed to require any labeling of these GMO fish, so consumers will not be able to effectively distinguish the genetically altered salmon from their non-GMO counterparts at the supermarket. The Center for Food Safety had recently submitted a citizen petition requiring labeling of “foods that are genetically engineered organisms, or contain ingredients derived from genetically engineered organisms” under the Federal Food, Drug, and Cosmetic Act. The FDA denied the petition claiming, “consumer interest alone does not provide a sufficient basis to require labeling disclosing whether a food has been produced with or without the use of such genetic engineering.” So while the overwhelming voices of concerned US citizens are still being ignored and minimized, the best way to avoid this risky salmon is to look for the Butterfly when buying seafood products with salmon ingredients and to avoid Atlantic salmon when buying fresh fish.
Multitudes of environmental concerns regarding this GMO salmon have surfaced including questions about what might happen if the fish escape, interbreed or compete for resources with native salmon. AquaBounty has already set a poor record of meeting environmental regulations. After growing the fish eggs on Canada’s Prince Edward Island, the company raises its fish in Panama. AquaBounty has received numerous fines from the Panamanian government for repeated environmental violations. While the FDA claims the approved facilities have appropriate safeguards in place to reduce the risk of salmon getting out, there are already instances of salmon escaping the facility—showing how inadequate the FDA’s studies have been. If these fish escape and make it into the North Atlantic, their impact on the native salmon could be irreversible. With the help of USDA funding, the AquAdvantage salmon have been engineered to be sterile, thereby reducing the risk for interbreeding within salmon. While we can only hope that the sterility is successful, the GMO salmon could interbreed not only with other salmon, but also with the genetically similar Brown Trout species.
The good news is that the fight is far from over. The Center for Food Safety has vowed to sue the Food and Drug Administration over the recent approval. Congress passed a spending bill in December 2015 that included language calling on the FDA to ban the sale of genetically modified salmon until the agency publishes rules about how the fish should be labeled. More than 60 grocery store chains have promised to keep this “frankenfish” off their shelves— including Costco, Kroger, Safeway, Target, Trader Joe’s and Whole Foods Market. There is no telling how this salmon will fare in the marketplace. At the start, AquaBounty’s Panama facility will only be able to annually produce 100 tons of salmon. Although this is only a fraction of the 200,000 tons of Atlantic salmon consumed annually by the United States, the AquAdvantage fish might make way for other genetically engineered animals to come surging through the flood gates.
What does this mean for the Non-GMO Project? In order for a genetically modified organism to be included in the high risk list of our Standard, the GMO must have received regulatory approval and also be commercially available. While the AquAdvantage salmon has received regulatory approval, it is not yet commercially available. According to AquaBounty, it will take up to two years for this GMO salmon to hit the supermarket. You can rest assured that we will be monitoring the situation closely and will provide updates as they happen.