More than 20 years after the first genetically engineered plant hit American grocery stores, the FDA has approved the first transgenic animal for human consumption: a salmon.
The AquaBounty Salmon, as it is known, is an Atlantic salmon genetically engineered to grow more rapidly than its non-GE counterpart, allowing it to reach market size in just 18 to 20 months, compared to the standard 28 to 36 months.
The FDA's announcement last week was met with frustration, if not surprise, by environmental and consumer groups, who point to inadequate information regarding the potential impacts of GE salmon on both the environment and human health.
"We were very disappointed in the FDA for this approval," says Michael Hansen, senior scientist with the Consumers Union, a nonprofit that works for a fair and safe marketplace for consumers. "We think it's based on bad science."
The GE fish was approved based on FDA findings that it is safe to eat, that the introduced gene is safe for the fish itself, and that the engineered salmon meets claims that it is faster growing than non-GE salmon. The approval pertains to two land-based salmon facilities: one in Prince Edward Island, Canada, where eggs will be produced, and one in Panama, where fish will be raised. The salmon raised in Panama will then be shipped back to the US for sale.
Hansen and other advocates have pointed to several areas in which the research relied upon by the FDA was severely wanting, including the impact of genetic engineering on human health, the impact of genetic engineering on the health of the fish, and the potential implications for wild fish populations.
Take, for example, the AquaAdvantage salmon's potential impact on wild fish. In its environmental assessment, the FDA found that the GE salmon would not have a significant environmental impact because they could not escape the Panama or Prince Edward Island facilities. Even if they did somehow escape, the FDA concluded the fish couldn't survive in the surrounding environments due to water temperatures.
However, the FDA did not conduct an analysis of the environmental impacts should the fish actually escape and survive in the wild. According to Hansen, that was a big oversight. The Prince Edward Island salmon facility is located near a stream, and there is a risk that fish could escape into nearby water bodies.
"They didn't do a failure mode analysis," Hansen says. "Normally you say, 'what happens if the safeguards fail?'"
JayDee Hanson, senior policy analyst with the Center for Food Safety, agrees that this was a major shortcoming of the FDA's analysis, especially given the proximity of the Prince Edward Island facility to endangered Atlantic salmon populations.
"Prince Edward Island does still have wild Atlantic salmon - not too many, they are hanging on," he says. "But they don't need really hungry genetically engineered fish eating up the food that they should be eating… We would be worried about [the GE salmon] literally decimating what is a barely hanging on wild population right now."
There is also a risk of cross-breeding. Although fish at the Panama facility will be sterilized, the Consumers Union asserts that up to five percent of the salmon could remain fertile. And, as Hansen points out, the fish producing eggs at the Canadian facility will not be sterile. If GE fish somehow escape the facilities, that could present an issue: A 2013 study found that genetically modified Atlantic salmon can hybridize with wild brown trout, a species that is common in areas surrounding the two approved AquaBounty facilities.
The health of wild salmon populations isn't the only thing at stake. Food advocates are also worried that, because GE salmon are engineered to grow more quickly, they will have higher levels of the growth hormone known as IGF-1, which has been linked to an increased risk of several cancers, including prostate, breast, colorectal, and lung. AquaBounty Technologies, the company that developed the fish, conducted a study comparing the IGF-1 levels between non-GE salmon and GE salmon - submitted to the FDA as part of the approval process - which concluded that "no biologically relevant differences were detected" in the levels of the growth hormone.
However, according to Hansen, the results of AquaBounty's test were troubling, due to insufficiently sensitive testing methods: "Here is an animal you engineer with a trait, a growth hormone, and you can't detect the trait in the animal at all," he says. The Consumers Union, in its September 2010 comments on genetically engineered salmon, contended that this result was "like the police using a radar gun that cannot detect speeds below 120 mph and concluding there is no 'relevant difference' in the speed of cars versus bicycles."
Consumer advocates are also concerned about the allergenic risks associated with GE salmon, and again point to insufficient and inadequate research on the part of AquaBounty. JayDee Hanson, senior policy analyst with the Center for Food Safety, says that AquaBounty was required to do two allergy-related tests: one for general allergenic reaction, and a second for salmon allergens. However, the sample sizes were "abysmally small," he says. They tested only six fertile fish for the general allergenic reaction study. "Six fish - that's below high school level statistics," he adds.
On top of the hormone and allergy concerns, the AquaAdvantage salmon may not have the same nutritional value as wild salmon. Specifically, studies indicate that it has significantly lower levels of healthy Omega 3 fatty acids.
The health of the GE salmon themselves could also be an issue. The fish in Panama will be triploid - which means they have three sets of chromosomes, instead of two - making them sterile. JayDee Hanson, of the Center for Food Safety, notes that triploid fish frequently have genetic defects, and that when they are engineered to grow more quickly, "the problems with triploid fish seem to be magnified." Specifically, they are more likely to have gill deformations, skeletal deformation, and focal inflammation of tissues.
"What bothers me about this is that this is a more sickly fish," Hanson adds. "To keep production up, the company might be tempted to add more antibiotics to the feed."
The FDA did not review the GE salmon under the regulatory framework for foods. Instead, in what Hanson calls a "bizarre fiction," the FDA regulates GE animals as new animal drugs, under the reasoning that, as the FDA puts it, the "recombinant DNA (rDNA) construct introduced into the animals meets the definition of a drug."
Adding insult to injury for anti-GE activists is the FDA's decision to adopt a voluntary labeling scheme, rather than requiring AquaBounty to label genetically engineered fish as such.
"Consumers have a right to know what they are eating," says the Consumers Union's Hansen. "This is information that is important to consumers."
Both decisions - to approve the fish and to adopt a voluntary labeling scheme - were made despite the fact that the FDA received roughly 2 million public comments in opposition to the approval of GE salmon, the largest number the agency has ever received on an action.
Environmental and consumer rights groups are concerned about the precedent the approval will have for other GE animals. AquaBounty has expressed interest in building a salmon hatchery in the United States, and is already developing GE trout and tilapia in addition to salmon, though it is unclear whether the company has submitted these fish to the FDA for approval yet.
"This sets a precedent for every engineered animal that comes after it," Hansen says. "It sets the bar for how stringent the approval [process] is going to be. And they just set the bar basically on the floor."
The Center for Food Safety has announced that it will sue the FDA over its approval of AquaBounty salmon. Environmental groups in Canada are also suing the Canadian government for approving the use of the Prince Edward Island facility for GE salmon egg production. And in the meantime, 59 retailers running 4,663 grocery stores in the US have said they will not sell genetically engineered seafood.
GE salmon won't be hitting the shelves tomorrow - it will likely be about two years before the fish even reach the market, if consumer advocates don't stop AquaBounty first. However, if the FDA's recent approval is any indication of how it will review GE animals in the future, these salmon could be the first of many GE animals that Americans may soon find on their dinner plates.