The AquAdvantage Atlantic salmon, which includes a gene from the faster-growing Pacific Chinook salmon enabling it to reach maturity twice as quickly as standard Atlantic salmon, is not harmful to the environment or human health when produced in contained hatchery tanks in Panama and Canada, said the agency.
Should AquaBounty or its partners wish to set up facilities in other locations in which to grow the fish, each would require FDA approval on a case-by-case basis, said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine.
“The FDA has thoroughly analyzed and evaluated the data and information submitted by AquaBounty Technologies regarding AquAdvantage Salmon and determined that they have met the regulatory requirements for approval, including that food from the fish is safe to eat.”
The FDA regulates GE animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act, because the recombinant DNA (rDNA) construct introduced into the animal meets the definition of a drug. In this case, the rDNA construct introduces a trait that makes the AquAdvantage Salmon grow faster.
While it will not be a legal requirement for the salmon - or indeed other GM foods - to be labeled as such unless there is a meaningful difference in safety or nutrition, the FDA has issued guidance documents “to help those manufacturers who wish to voluntarily make the distinction on the labeling of their food products.” They will both be open for comment from Nov 23 HERE.
Companies wishing to label GE foods might use phrases such as: 'Some of our growers plant soybean seeds that were developed through modern biotechnology to be drought tolerant.'
Firms wishing to flag up the fact that they are not using GE ingredients, meanwhile, are advised against using the term ‘GMO’ (genetically modified organism), an acronym that the FDA says can create “potential confusion”.
Instead firms should consider phrases such as ‘Not genetically engineered’ or ‘Not genetically modified through the use of modern biotechnology’ or ‘We do not use Atlantic salmon produced using modern biotechnology’ said the FDA, although it won’t take enforcement action against firms using the term 'GMO' provided the labeling is “not otherwise false or misleading”.
Multiple measures are being taken to contain the fish, said the FDA, while the Canadian and Panamanian governments will also be conducting regular inspections of the facilities: “These measures include a series of multiple and redundant levels of physical barriers placed in the tanks and in the plumbing that carries water out of the facilities to prevent the escape of eggs and fish. Finally, the AquAdvantage Salmon are reproductively sterile so that even in the highly unlikely event of an escape, they would be unable to interbreed or establish populations in the wild.”
However, Tim Schwab, senior researcher at anti-GM lobby group Food & Water Watch, claimed in 2013 that AquaBounty’s sterilization process was "imperfect", and argued that the FDA's review process had revealed that "up to 5% of GE salmon could be fertile, which could amount to many thousands or even millions of fertile fish [potentially escaping and breeding with wild fish] once commercial production begins.”
‘This offers an alternative approach to fish farming that does not exploit the oceans’
AquaBounty CEO Ronald L. Stotish, Ph.D., who noted that the US currently imports more than 95% of the Atlantic salmon it consumes, said wild-caught fish deplete oceanic stocks and do not present a long-term, ecologically sustainable solution to rising global fish demand.
AquAdvantage salmon was a “game-changer that brings healthy and nutritious food to consumers in an environmentally responsible manner without damaging the ocean and other marine habitats,” he claimed. "Using land-based aquaculture systems, this rich source of protein and other nutrients can be farmed close to major consumer markets in a more sustainable manner.”
The company added: “Through greater efficiency and localized production, AquaBounty’s AquAdvantage Salmon increases productivity while reducing costs and the environmental impacts associated with current salmon farming operations. Land-based aquaculture systems can provide a continuous supply of fresh, safe, traceable, and sustainable AquAdvantage Salmon to communities across the US and do it with a reduced carbon footprint. Importantly, it offers an alternative approach to fish farming that does not exploit the oceans.”
Dr Muir: There is no credible evidence that these fish are a risk to either human health or the environment
Dr William Muir, professor of genetics, at Purdue University, said the decision was long overdue - but a "huge win-win for the environment, consumers, and the process."
He added: "The scientific review is clear, there is no credible evidence that these fish are a risk to either human health or the environment. In contrast, the current practice of using wild caught salmon as a food source is not sustainable, our oceans are over fished. This development provides a safe and sustainable alternative. Further, this opens the door for the use of biotechnology as a tool to improve US food production in other species and in other ways to help feed a growing population.
"This GE technology has been on hold for over a decade waiting for confirmation that the process works, i.e. that the FDA can regulate product of biotechnology through use a rigorous scientific method or be constrained by political considerations. The answer is now clear, the process works, and all sectors will benefit."
"The development of AquAdvantage Salmon is based on more than two decades of scientific research, making it the most studied line of Atlantic salmon... Animal biotechnology can improve livestock to require less feed, produce more protein, and reduce environmental impact, while also providing for enhanced animal health and welfare."
Biotechnology Industry Organization (BIO) president and CEO Jim Greenwood
CSPI biotechnology director Gregory Jaffe also welcomed the decision, but added: "While FDA will not require that GE salmon steaks be labeled, it is critical that the marketing of GE salmon products be transparent. Consumers who want information about the GE salmon should be able to obtain it, either on the label, in printed materials associated with the product, on a website, or through other communications."
He also noted that GE plants did not go through such a rigorous assessment process from the FDA: "While the current GE crops grown in the U.S., too, are perfectly safe to eat, developers of GE crops have only been subject to the FDA’s voluntary consultation process where the agency reviews safety data, but does not provide a ruling that foods and ingredients from the crops are safe."
What happens if the GE salmon escape?
In a 2013 article in the Food & Drug Law Institute’s Food and Drug Policy Forum, biotech experts Dr Alison L. Van Eenennaam, Dr William M. Muir, and Dr Eric M. Hallerman point out that the GE salmon are sterile. However, should they escape from enclosed FDA-regulated facilities, selection over time would be expected to purge the transgene from any established salmon population, they added.
"Based on the data, the long-term risk of GE salmon [multiplying in the wild] is close to zero as no fitness advantages in any component were demonstrated, resulting in a purge scenario for the transgene."
They added: “No Atlantic salmon has ever successfully mated with any of the Pacific salmon species and so fears that sterile, female Atlantic salmon housed in a contained facility in the highlands of Panama will escape, migrate to the ocean, and then traverse thousands of miles across tropical seas and interbreed with wild Alaskan Pacific salmon are scientifically unfounded.”
'People don’t want to eat it and grocery stores are refusing to sell it'
However, opponents – who continue to argue that the GE salmon could present “serious health risks” and “decimate wild salmon populations” - were quick to condemn the FDA’s decision this morning, with Wenonah Hauter, executive director at Food & Water Watch arguing that the FDA should have conducted a “more thorough environmental impact statement that would fully consider the threat this controversial new fish could pose to wild fish populations and ecosystems”.
He added: “To add insult to injury, this product will be hitting store shelves without labeling, making it impossible for concerned consumers to distinguish GMO from non-GMO salmon.”
Moms Across America founder Zen Honeycutt immediately called for “all consumers to boycott GMO Salmon”, while the Center for Food Safety announced plans to file a lawsuit challenging the FDA’s “dangerous and unlawful” decision.
More than 60 grocery store chains representing 9,000+ stores across the U.S. have made commitments to not sell the GE salmon, including Safeway, Kroger, Target, Trader Joe’s, Whole Foods, Aldi and many others, added Friends of the Earth food and technology program director Lisa Archer.
“People don’t want to eat it and grocery stores are refusing to sell it.”
'Their worst fear is that there will be a market for the fish'
However, biotech researchers argue that opposition to the technology is often politically or commercially motivated, and that it doesn’t make sense that the trigger for regulatory review is the process used to produce an animal or plant, rather than the unique characteristics and attributes of the animal or plant in question.
Speaking to FoodNavigator-USA last year, Dr Stotish said opponents of the technology continued to promulgate claims “they know to be untrue”, however, adding: “Their worst fear is that there will be a market for the fish.”
AquaBounty - which has offices in Maynard, Massachusetts and Fortune, Prince Edward Island - first submitted its investigational new animal drug application in 1995.