Frankenfish: genetically engineered salmon close to winning FDA approval

As AquAdvantage salmon nears FDA approval, this genetically engineered fish is likely to show up on your plate – and you may not even know it.

By Andrea Pokrzywinski

By Andrea Pokrzywinski

From my column in Communities @ Washington Times

WASHINGTON DC, February 2, 2013- Genetically modified crops have been a part of the U.S. food supply for many years.  Genetically engineered (GE) animals, however, have not.

If successful, AquAdvantage® salmon will be the first genetically engineered animal allowed into the U.S. food supply.

AquAdvantage salmon is an Atlantic salmon that has two added genes; an added gene from the Pacific salmon to make it grow faster, and an added gene from an eel that makes it grow throughout the year.  GE salmon grow in half the time – 18 months instead of three years- but do not grow larger than natural salmon. Currently AquAdvantage eggs are created in Prince Edward Island and the fish are grown and farmed in Panama.

AquAdvantage creator, Massachusetts-based AquaBounty, has been working to obtain FDA approval to market its product for human consumption in the U.S. for 17 years.  Currently in the final stages of the lengthy New Animal Drug Application (NADA) required by FDA, GE salmon could reach American plates as early as the end of 2013.

The FDA concluded in 2010 that the AquAdvantage salmon was safe for human consumption. Clearing the salmon of a final hurdle in December of 2012, the FDA’s draft environmental assessment concluded that AquAdvantage fish did not pose a threat to the U.S. environment.  This draft assessment will be open to public comments for 60 days.

By clearing this last major regulatory hurdle, it is likely that AquAdvantage will gain FDA approval despite opposition and make its way into the American food supply by the end of 2013.  While the debate over GE animals rages on, there is also a growing question concerning the labeling of these foods once they are on the market.

The controversy

There are compelling arguments on both sides of the issue of whether to allow genetically modified animals into our food supply.  Most of the arguments center on whether GE animals are safe for human consumption, whether they pose a threat to the environment, and whether they should be labeled as GE foods.

Supporters of AquAdvantage and similar products argue that genetically modified animals will produce a low-priced, high-quality protein that is not a threat to the environment and is safe for human consumption.

On the other side of the argument, Andrew Kimbrell, executive director for Center for Food Safety (CFS) says that “GE salmon has no socially redeeming value; it’s bad for the consumer, bad for the salmon industry and bad for the environment.”

In 2010, as part of the FDA investigation of the AquaBoyndy’s NADA application, the FDA tested six specimens.  Based on the results of these tests, many health professionals agreed with the FDA assessment that the salmon is unlikely to cause more allergies or harmful effects than natural salmon.

However, opponents argue that testing, especially on the possible long-term health effects of consuming genetically engineered fish, has not been adequate.  According to the Organic Consumers’ Association (OCA), “even with such limited testing, the results showed an increase in allergy-causing potential, […] AquAdvantage also contains elevated levels of the growth hormone, IGF-1, which is linked to prostate, breast and colon cancers.”

Opponents also argue that little is known about the long-term effects GE organisms have on the environment. GE fish grow twice as fast as natural salmon, eat five times as much, have less fear of natural predators, and can reproduce throughout the year. While FDA’s environmental assessment concludes that the salmon will not have a negative impact on environs surrounding the U.S., FDA did not require a similar study in the waters around Prince Edward Island, where the eggs are currently produced; or Panama, where the fish are being farmed.

The FDA assessment concluded that it is unlikely the fish will escape their farms and pose a threat to natural species, including the endangered Atlantic wild salmon.  This is because the fish “will be grown as sterile, all-female populations in land-based facilities with redundant biological and physical containment,” according to AquaBounty and the FDA. AquaBounty also claims that even if some individuals manage to escape, they will not survive the salty warm waters surrounding the Panamanian facility.

Critics note, however, that an escaped fish could impact local populations.  Only 95% of the fish are actually sterile, and even though theoretical studies suggest the fish are unlikely to survive should they escape, there is no proof that they will not survive.  Neither the FDA nor AquaBounty performed an environmental assessment in Panama to determine the impact if an escaped salmon does survive, so the effect of escaped fish is relatively unknown.

Moreover, despite AquaBounty’s claims that their GE faming methods are safer than traditional aquaculture, CFS provided evidence that AquaBounty’s Canadian production site was contaminated by a new strain of Infectious Salmon Anemia, an untreatable virus that affects salmon. However, CFS claims that information about the facility’s contamination with this deadly fish flu was not considered by the FDA and was hidden from the public.

The labeling issue

Once approved, which is very likely, AquAdvantage salmon will not require special labeling identifying it as genetically engineered.  Under current FDA regulations, GE foods are only required to be identified as such when they are substantially different from the natural version.  The FDA stated that AquAdvantage salmon is not substantially different from its natural counterpart, and therefore will not require special labeling.

Without special labeling of GE salmon, consumers will lack information to allow them to choose whether to consume and financially support a completely new kind of food and food industry—one that we know very little about.

Additionally, FDA approval of AquAdvantage salmon is likely to set precedent for other GE foods.  Firms that produce GE cows, chickens, and pigs are eagerly awaiting the results and are poised to petition for approval if AquAdvantage wins FDA authorization. If AquAdvantage ultimately does gain approval, it should be easier for these products to do so as well.

As FDA regulations stand, none of these genetically engineered foods would require special labeling identifying them as GE foods, and consumers will have no clear way of knowing whether they are eating food from a GE animal.

Writer Peter Murray calls the move toward genetically engineered food a “grand experiment.” Shouldn’t American consumers have the right to decide – and the information to make a choice about — whether they want to be part of that experiment?