The Food and Drug Administration released its Environmental Assessment (EA) report for genetically modified (GM) salmon developed by AquaBounty Technologies.
This is one of the last steps for the first transgenic animal to be considered for federal approval, with an approval process that’s been in limbo for 17 years.
The FDA concluded the salmon would have “no significant impact on the environment and was as safe as food from conventional Atlantic salmon.”
The EA report is expected to be officially published in the Federal Register today. Forbes contributor Jon Entine claims the next step is a public review period, which will last 60 days.
“The FDA will then evaluate the public comments and consider a second review period. Unless some dramatically new information emerges from the public responses, the FDA would issue it’s formal approval sometime in 2013.”
And the FDA has no intention of labeling AquaBounty’s GM salmon. The FDA claims that since they’ve concluded there’s no material difference between the flesh of the GE fish and the flesh of regular farm-raised Atlantic salmon, they aren’t required to be labeled separately.
That means unlabeled GM salmon could be on dinner tables by 2014, and consumers will have absolutely no clue as to whether the salmon they buy is genetically modified.
The EA stated that the Center for Veterinary Medicine, which has regulatory responsibility within the FDA, had reached a “no effect” determination under the Endangered Species Act.
But in 2010 hearings on transgenic fish, the FDA knowingly withheld a Federal Biological Opinion by the U.S. Fish and Wildlife Service and National Oceanic and Atmospheric Administration prohibiting the use of transgenic salmon in open-water net pens pursuant to the U.S. Endangered Species Act (ESA).
“This adds further evidence that in fact GE salmon pose a serious threat to marine environments and is another compelling reason for the FDA not to approve the fish for commercial use,” said Andrew Kimbrell, Executive Director of the Center for Food Safety.
“While the FDA applauded the company’s choice of land-based containment as responsible, it never revealed that it is illegal in the U.S. to grow genetically engineered salmon in open-water net pens.”
The Independent’s Steve Connor notes that GM opponents stress the introduction of GM salmon creates risks for both human health and the environment.
“They also argue that the salmon will be the start of concerted efforts to create other GM animals for human consumption, which could raise serious questions about animal welfare.”
Many in opposition to GM salmon have claimed the FDA’s approval is based exclusively on the limited and inadequate studies conducted by AquaBounty Technologies.
Michael Hansen, senior staff scientist with Consumers Union said the FDA approval panel was mostly comprised of GE cheerleaders, with no fish ecologists or allergists despite the AquaBounty tests suggesting the new GM salmon could be much more allergenic than regular salmon.
Hanson explains that AquaBounty did incredibly small sample sizes in their studies, and that the largest sample size of the fish being examined for morphology was 12 animals.
“They found that the skeletons are worse than in normal farmed salmon, that their jaws are eroded more than in normal farmed salmon, that their gills are enlarged and that their flesh is inflamed.”
But they say that it’s OK to eat, said Hanson.
Hanson said they need more data on the allergy question, and adds that fish are one of the top five foods people are most allergic to and the sample size used in the testing was far too small — six fish in all — to determine whether consumers could be allergic.
In addition to the allergen problem, there’s evidence that AquaBounty’s GM salmon might have higher levels of a cancer promoting hormone IGF-1, as well as more antibiotics.
Opponents also argue GM salmon could escape into the wild, interbreed with wild fish and undermine the genetics of the endangered Atlantic salmon.
But AquaBounty claims their genetically engineered fish will be only be grown as sterile females and kept in secure containers on land.
Lord Melchett, UK policy director at the Soil Association says once you have bombarded an animal with other genes, the DNA is unstable, and there is no guarantee these fish remain sterile.
“It poses far too great a risk to wild salmon. A fish that grows that quickly is likely to lose some of its environmental benefits. There is no such thing as a free salmon lunch and we will pay the price,” he said.