FDA Approves Genetically Engineered Salmon With No Label Requirement
WASHINGTON, December 3, 2015—The Food and Drug Administration (FDA) recently approved AquaAdvantage salmon, making it the first genetically engineered animal available for human consumption in the United States. While supporters of genetically modified foods are encouraged by FDA’s approval, critics cite environmental and labeling concerns.
AquAdvantage salmon is the product of AquaBounty, a Massachusetts-based bioengineering firm. It is an Atlantic salmon with an added gene from a Chinook salmon and another added gene from the ocean pout—a kind of eel—which allow the AquAdvantage salmon to grow larger and more quickly (18 to 20 months, compared to 28 to 36 months) than non-genetically engineered Atlantic salmon.
Currently, AquaBounty produces the salmon outside the U.S.; the eggs are created at a lab on Prince Edward Island in Canada and the fish are subsequently grown and farmed in landlocked tanks in the mountains of Panama.
AquaBounty’s chief executive, Ronald Stotish said that he was delighted and surprised by the approval in late November, given that the approval process has taken over 20 years.
“We had no indication that approval was imminent,” he said in an interview with the New York Times.
Supporters of AquAdvantage salmon contend that genetically modified animals can produce a sustainable, low-priced, high-quality protein that is safe for human consumption. Moreover, they argue that when properly managed, genetically engineered salmon is not a threat to the environment.
However, the genetically engineered salmon has a large number of critics. In 2013, FDA received nearly two million public comments, a large majority urging it not to approve AquAdvantage salmon, many citing environmental concerns.
As part of its approval process FDA published an environmental assessment in November 2015, concluding that AquAdvantage fish production on Canada’s Prince Edward Island and Panama does not pose a threat to the U.S. environment. FDA did not require environmental impact studies of the waters around Prince Edward Island or the area around the Panama facility, which is adjacent to a river.
Critics argue FDA’s assessment was inadequate and that little is known about the effects of genetically engineered animals on the environment. Genetically engineered salmon grow twice as fast as natural salmon, eat five times as much, have less fear of natural predators, and can reproduce throughout the year, compared to non-genetically engineered salmon. It is unknown what kind of an impact an escaped fish would have on natural environments. Certain critics believe that fish that manage to escape and survive could significantly impact local fish populations, outcompeting native species for food and resources.
However, FDA’s assessment concluded that it is unlikely the fish will escape AquaBounty facilities and pose a threat to natural species, including the endangered Atlantic wild salmon. According to AquaBounty, fish “grown from AquAdvantage eggs are all female and sterile, making it impossible for them to breed among themselves and with other salmon. In addition, FDA approval requires them to be grown in physically contained land-based systems, further reducing any potential impact on wild populations.”
Even if some individuals manage to escape, claims AquaBounty, they will be unable to survive the warmer waters of the river near the Panamanian facility. However, even though theoretical studies suggest the fish are unlikely to survive should they escape, there is no hard evidence that they will not survive. According to comments submitted by Consumers Union, FDA’s assessment overlooks a 2010 study that found that genetically engineered Coho salmon grew faster at higher water temperatures (18°C vs 12°C) than did non-genetically engineered Coho salmon.
Additionally Consumer’s Union points out that only 95 percent of AquaBounty fish in the Panama facility will actually be sterile. “Since millions of eyed eggs will be sold, this could result in a significant number of fertile female AquAdvantage Salmon,” states the advocacy group.
JayDee Hanson, senior policy analyst with the Center for Food Safety, also points out that the fish producing eggs in the Canadian facility will not be sterile.
Critics are concerned that if a genetically engineered fish escapes either facility, it will be able to breed with wild species. A 2013 study found that it was indeed possible for genetically engineered salmon to hybridize with wild brown trout, a fish commonly found in waters surrounding both AquaBounty facilities.
Right now, the environmental risks may appear minor.
“We are expecting very little risk at the moment, because there are very few facilities that actually hold these fish,” said Fredrik Sundström, an ecologist at Uppsala University in Sweden to NPR. “I think what’s a worry to some people is if it becomes commercialized and you find these kind of fish in millions of hatcheries around the world.”
But this is exactly what AquaBounty has in mind. According to the New York Times, AquaBounty has plans to build a new hatchery in the U.S. and to expand the facility on Prince Edward Island to be able to sell eggs to independent fish farmers who will grow the salmon. It will then be up to all of these individual fish farmers to ensure that the salmon do not escape their farms.
Additionally, a recent Truthout article raised the issue of AquaAdvantage salmon health. To make them sterile, AquAdvantage fish in the Panama facility will be triploid, meaning they will have three sets of chromosomes instead of two. According to JayDee Hanson, of the Center for Food Safety, triploid fish tend to have more genetic defects, including skeletal deformation, gill deformations, and focal inflammation of tissues.
“What bothers me about this is that this is a more sickly fish,” Hanson said to Truthout. “To keep production up, the company might be tempted to add more antibiotics to the feed.”
AquAdvantage salmon does not require a label identifying it as a genetically modified food. Under current FDA regulations, genetically engineered foods only need to be labeled when they are substantially different from the natural version. Since FDA’s position is that AquAdvantage salmon is not substantially different from its natural counterpart, it will not require special labeling identifying it as genetically engineered.
FDA released voluntary guidelines for labeling, but according to Food & Water Watch assistant director Patty Lovera, it is highly unlikely that companies marketing AquAdvantage salmon will actually opt to label their products.
For now, the only way to tell whether salmon is genetically engineered is to rely on country-of-origin labels (COOL) and labels indicating whether the fish is wild caught of farmed, which are required by the U.S. Department of Agriculture (USDA). As Elizabeth Grossman explains in an article in KQED, there is no commercially grown salmon coming into the U.S. from Panama, so informed consumers will be able to identify AquAdvantage salmon if “Panama” and “farm-raised” appears on the COOL label.
However, COOL requirements do not apply to salmon combined with other ingredients or cooked, and they do not apply to restaurants and foodservice establishments. While those who supply restaurants and processors must make information regarding country of origin and whether the fish is wild caught of farmed to restaurant owners and food processors, the restaurants and food processors do not have an obligation to pass this information on to their customers.
Moreover, there is currently a bill aimed at preventing states from passing their own GMO labeling requirements making its way through Congress. Introduced by Rep. Mike Pompeo (R-KS), the Safe and Accurate Food Labeling Act of 2015 passed the House of Representatives in July.
FDA approval of AquAdvantage salmon is likely to set a precedent for other genetically engineered animals. Several labs developing genetically engineered cows, chickens, and pigs will likely petition for approval if AquAdvantage is well received by consumers.
However, it is not clear whether consumers will embrace AquAdvantage salmon and other genetically engineered animal products. To date, a large number of food producers, chain restaurants and retailers have already stopped using and selling genetically modified products; others have imposed a labeling policy. Moreover, giant retailers like Costco, Whole Foods, Target, Trader Joe’s and Aldi have all stated that they will not sell AquAdvantage salmon.
Americans are not likely to find AquAdvantage salmon on their dinner plates or grocery stores in the immediate future. AquaBounty estimates that it will take them about two years to reach U.S. markets, and initially, it will be a small quantity. Aqua Bounty’s Panama plant can produce up to 100 tons of fish per year, which represents a very small percentage of the 200,000 tons of Atlantic salmon imported into the U.S. every year.
This is likely to change if AquaBounty expands its operations and if other firms decide to seek approval for their genetically engineered animals.