Remember Frankenfood? No, that’s not the name of a long-forgotten, sugary kids cereal. It’s the moniker given to GMO food including corn, soy, canola, and cotton by critics. And there are many.
Through modifications at the genetic level, GMO technology makes seeds resistant to heavy doses of herbicides. In some cases, seeds are modified to generate pesticides themselves, as in the case of Bt corn and cotton, for example, where the seed expresses a toxin to kill pests.
But the technology has seen other iterations, including genetically modified salmon designed (way back in 1989) to reach market weight in a fraction of the time as non-GMO salmon. The fish, AquaBounty's AquAdvantage Salmon, has been in regulatory limbo since 2015. And a new federal court ruling issued earlier this month says it’s still not ready for the U.S. market.
According to the court, the FDA needs to revisit AquaBounty’s GMO salmon due to the risks if fish escape their enclosures. The judge said the agency failed to fully consider these risks before it issued its approval. If approved, the salmon would be hatched in Canada and raised in pens in Indiana, with other farm facilities already in the works in Kentucky.
The judge's decision requires the FDA to “finally grapple with what scientists both inside and outside the government have been telling it for a very long time," said Earthjustice lawyer Stephen Mashuda, who represents conservation and fishing industry groups that sued the FDA, “which is that there are unacceptable risks from genetically engineered salmon.”
Those critical of GMO foods are largely concerned with two core issues. First, there’s the increased pesticide and herbicide loads sprayed on crops such as corn and soy. Many of these chemicals have been linked to serious human health issues, including an increased risk of cancer. That connection led to the first court ruling of its kind in 2018, when California groundskeeper Dewayne Johnson was awarded more than $280 million in a lawsuit claiming that Monsanto’s glyphosate-based Roundup weedkiller was the source of his fatal non-Hodgkin’s lymphoma. (Johnson later accepted a reduced award of $78 million.)
The second issue, though, is the technology itself. What exactly happens to a seed — or a fish — when genes are altered? Does that modification impact other profiles, like nutrient density or allergen risks? Could it even increase the risk of expressing latent toxins? Those questions haven’t been fully answered by the industry. And according to the FDA, bioengineered foods (the new regulatory term for GMO) are functionally identical to non-GMO foods.
But that's not necessarily the case. The risks, at least in part, became evident back in 2000 when a batch of GMO corn called StarLink approved only for livestock made its way into the food system. Several dozen people who consumed the corn reported adverse allergic reactions, forcing an FDA investigation into seven of those cases. There was concern over Cry9C, a medium-risk potential human allergen in the corn, but the findings were inconclusive.
When it comes to genetically modified animals, there are potentially more devastating consequences to the environment and, in this case, endangered fish.
AquaBounty’s AquAdvantage salmon is a genetic hybrid between an ocean pout and Pacific Chinook. The FDA gave the fish approval five years ago, but it’s been facing legal hurdles ever since.
The fish was granted approval as a “drug” per the FDA’s Food, Drug, and Cosmetics Act. But the same judge who first gave FDA authority to approve the fish rejected the agency’s position earlier this month.
According to court filings, the FDA argued that it wasn’t bound to consider the environmental impact of GMO animals. The agency said its only responsibility is to ensure a drug, even if it’s actually a fish, is “safe for use.”
U.S. District Judge Vince Chhabria disagreed.
“Even if the FDA is correct that environmental considerations writ large were not relevant to its decision, the agency is always required to consider the subset of environmental impacts that directly involve the health of animals or humans,” the judge wrote.
The FDA argues that it imposed restrictions on AquaBounty in 2015 when it first approved the fish. It claims the hatcheries would be very difficult for the fish to escape.
But despite that consideration on prevention, the agency failed to address the “what if” question: What if any number of these modified fish did get into the open water? What if they mated with non-GMO fish?
“Even if this scenario was unlikely, the FDA was still required to assess the consequences of it coming to pass,” Chhabria wrote.
Now, the agency must review the risk factors and the potential of “genetic pollution” — breeding with non-GMO fish. The agency must also review the possible threats to the endangered Gulf of Maine Atlantic salmon population. Only 1,200 are estimated left in the wild, according to the National Oceanic and Atmospheric Administration Fisheries. Mating with GMO fish could further impact the species.
The judge didn’t reverse approval of the AquAdvantage salmon altogether.
“Revoking the approval would presumably require the current stock of salmon to be destroyed, a significant loss of property and animal life that would be wasteful given the real possibility that the FDA will be able to cure the [National Environmental Policy Act] and [Endangered Species Act] errors on remand,” Chhabria wrote.
In a statement, AquaBounty CEO and President Sylvia Wulf said the company is pressing on, despite being disappointed with the judge’s ruling.
“This decision will not have an impact on our on-going operations on Prince Edward Island, Canada, to produce eggs or in the raising and selling of AquAdvantage salmon from our farm in Indiana,” Wulf said. “We are committed to working with FDA on next steps and continue to evaluate the legal decision.”
Assessing the Risks
So now the question remains as to whether or not GMO fish could integrate into the wild and just exactly what impact they could have. For Sarah Jane Alger, writing in Nature back in 2015, the fact that accelerated growth rates – the main effect of the genetic modification – have not naturally evolved in wild salmon "suggests that they would be disadvantageous in a natural setting."
“For one thing, fish with excessive growth hormone sometimes have abnormal skull shapes or organ sizes that can reduce their ability to compete and survive in harsh natural conditions," continues Alger.
But she also notes that the excess growth hormone in the fish means higher metabolisms and thus more ravenous appetites.
"Their high feeding drive means that, if they were to escape, they could potentially outcompete native fish for food.”
But Alger also pointed out that their feeding drive could push them toward their own demise: “their feeding drive is often so high that they spend more time at the water surface, which exposes them to more predators, which may remove them from natural environments sooner. In fact, research suggests that many GMO fish with excess growth hormone only have faster growth rates in highly controlled tanks with lots of food; if food is not abundant and predators are present, some GMO fish actually grow slower than their wild counterparts.”
There is still a lot we don't know about this salmon, and that, critics say, is a problem in and of itself. Fish is already a common allergen, like corn and soy. And, like with the StarLink corn issue, it’s not yet known what kind of human health risk GMO salmon could have on sensitive individuals.
According to GM Watch, AquaBounty “botched” its test for allergic reactions and wasn't required to re-test. “They did another test that was really small, on just six fertile fish and six regular fish," Jaydee Hanson, the Senior Policy Analyst at the Center for Food Safety in 2017 said in an interview at the time. "They found the fertile genetically engineered fish were so likely to cause allergic reactions that the FDA said, ‘We’re not going to let you sell fertile fish.’”
Critics of the fish also question whether the GMO fish could be more susceptible to parasites, putting those who consume the fish at risk as well of contamination.
And there's also the issue of transparency to consider. After all, under its current approval language, markets and restaurants would not need to note the salmon was genetically modified. Although a number of supermarkets pledged to voluntarily label the fish, it's still likely to appear in stores and on menus without clear labeling.
Despite all these risks, if AquaBounty and the FDA can satisfy the court requirements, AquAdvantage could be in the food supply as early as next year.
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