By Jaydee Hanson

from GeneWatch 28-3 | Oct-Dec 2015


On November 19, 2015, the Food and Drug Administration approved the first genetically engineered animal intended to be eaten as a food, an Atlantic salmon (Salmo salar) engineered to express the growth hormone from the huge Chinook salmon (Oncorhynchus tsawytscha) continuously. This could be the first of many such approvals. Worldwide, more than 50 fish have been engineered. The company, AquaBounty, has announced that it also has genetically engineered trout and tilapia for which it may seek FDA approval.

FDA used the wrong law

FDA announced in 2009 that it would review genetically engineered animals as "new animal drugs." That is, they decided to review this fish as though the genetically engineered DNA construct was a new drug for the animal, not reviewing the animal as a new food for people. The agency could have used its various food authorities or sought new legislation from Congress on reviewing "novel" foods, as other countries have done.  The Center for Veterinary Medicine is one of the only parts of the FDA that lacks expertise in reviewing human trials for either food or drugs. Also, by choosing to review the animal as a drug, the agency must keep its review confidential. Had AquaBounty not advertised that it had submitted the fish for FDA review, the public would not have known that FDA was reviewing the fish.

Food safety review was inadequate

FDA did not require the AquaBounty company to conduct any human or animal feed studies that would examine the safety of humans or animals eating the fish, but several problems are likely. Routine use of antibiotics such as the ones used by the company in its research facilities is known to cause human health problems and diminish the effectiveness of related human antibiotics. The fish has also been sterilized by the insertion of an extra X chromosome into the eggs. This process, known as triploidy, causes skeletal and gill problems in fish, and these problems seem exacerbated in the AquaBounty fish, probably due to the excess hormone levels.

The fish also may pose higher allergenicity problems than ordinary salmon. Even in the small number of fish (6 fertile and 6 sterile fish) tested by the company, the fertile fish were found to have an increased likelihood of causing an acute allergic reaction in humans. The sample size is too small to say that the sterilized fish won't show an increased risk, too.

In 2009, a study commissioned by the EU raised several food safety concerns about GE fish, including their higher levels of growth hormones and their higher tolerance of environmental toxins. The data released by the FDA shows that the AquaBounty salmon may have a 40% higher level of a hormone called IGF-1 (insulin-like growth hormone factor 1), which has been shown to increase the risk of certain cancers, including breast cancer.

These GE salmon also have lower levels of the beneficial omega fats that wild salmon provide. They even have, according the company's own data, lower ratios of healthy Omega 3 fats to unhealthy Omega 6 fats than do farmed salmon.

Inadequate environmental review

The FDA approved this GE fish without fully reviewing the potential environmental impacts of the fish escaping into the wild. The only fisheries scientist on the FDA Advisory Committee that reviewed the fish called on the FDA to develop a full environmental impact statement. Geneticists working for the U.S. Fish and Wildlife Service warned that the FDA Environmental Analysis is overly simplistic and does not adequately capture the actual risk of environmental damages to wild Atlantic salmon or the ecosystem as a whole. The FDA failed to require studies of the potential for interbreeding with wild salmon, studies of the incorporation of genes from the GE salmon into the gene pool of wild salmon, or studies on the likelihood of hybridization with the closely related brown trout, a fish that is found throughout many parts of the U.S. and Canada. Further studies are needed that look at the likelihood that escaped GE salmon would disturb the habitat of endangered populations of wild salmon, as the GE salmon would compete for resources with the wild salmon. Even unsuccessful attempts to mate with the GE fish would reduce the likelihood of subsequent successful matings of the wild salmon. Moreover, the GE salmon could spread disease to wild salmon and other species.

Escapes of GE salmon from Prince Edward Island, where AquaBounty is raising the fertile GE salmon, could affect wild salmon throughout the entire range of wild Atlantic salmon. Atlantic salmon are known to travel extensively from the areas where they have spawned; tagged salmon from Maine have been caught off the coast of Greenland. The ecological impacts associated with the effects of the GE salmon, the likelihood of their persisting in the ecosystem, and the likely dispersal of the GE fish throughout the waters of the Atlantic should have been studied before the approval of this fish. 

A plan for monitoring the AquaBounty company's procedures to prevent escapes and to assure that the production facility's employees do not take eggs or fry from the facility and grown them out in unapproved locations needs to be in place. The company has been fined for failing to comply with Panamanian environmental laws in its Panama location. The company failed to report in its submission of data to the FDA in 2010 that its Prince Edward Island facility had a major outbreak of ISA, a fish flu that can devastate fish populations. Canadian, Panamanian, and U.S. authorities will have to closely monitor this company's production facilities to assure that it does not cause serious environmental problems that spread beyond the production sites. In mid-December, AquaBounty announced that it planned to sell eggs to fish farmers in other countries and for growth in other locations in the U.S. This makes it even more likely that the genetically engineered salmon will escape confinement and cause great ecological problems.

Pushback - labeling and lawsuit

The FDA decided not to require this new GE salmon to be labeled. Nonetheless, a bi-partisan effort in the Senate headed by Senators Murkowski (R-AK) and Cantwell (D-WA) inserted a provision into the Omnibus government financing bill requiring that FDA develop a labeling program that will indicate to consumers whether the salmon they are buying is GE or not. The provision prohibits sale of the fish in the U.S. until they are labeled.

Finally, a coalition of consumer and environmental groups headed by the Center for Food Safety and Earth Justice has announced that they are suing to stop the approval of the fish.


Jaydee Hanson is Senior Policy Analyst at the Center for Food Safety.


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