by Lucy Sharratt
Some say genetic engineering was always fishy, but now the fish themselves are engineered.
Genetically engineered (GE) canola, corn, soy and sugar are already in our grocery stores, but GE fish and pigs could be next. Salmon is the next genetically engineered – also called genetically modified or GM) – food lined up for introduction to the market. AquaBounty, a Massachusetts-based biotechnology company, is asking the US to approve its genetically engineered Atlantic salmon for human consumption and says it will soon seek approval in Canada as well. The company claims its “AquAdvantage” salmon grow to market-size twice as fast as other farmed salmon. Consumers should be aware of the reason for this: Atlantic salmon are engineered with a growth hormone gene from Chinook salmon and genetic material from ocean pout (an eel-like creature). The fish produce growth hormone throughout the year, rather than for the three months they normally would.
After 10 years of consideration, the US government is about to approve the GE salmon. Or are they? On August 25, the US Food and Drug Administration (FDA) announced the final stages of its process to approve the GE salmon. The FDA called on its Veterinary Medicine Advisory Committee (VMAC) to discuss the science submitted by AquaBounty and to hear from public interest groups, in two days of public meetings in September.
Just two weeks before the meetings, the FDA released two documents that summarize the data presented by AquaBounty and the FDA’s analysis of that science. The FDA’s preliminary conclusion was GE salmon is safe to eat and does not pose a risk to the environment. However, many committee members at the public meetings voiced serious concerns about the quality of the data, asking for more and better studies.
AquaBounty now says it is preparing to ask for approval in Canada. As it turns out, the company’s entire plan to introduce GE salmon fillets into the US relies on producing GE salmon eggs at its facilities in Prince Edward Island (PEI).
Until now, only the FDA and AquaBounty knew that Canada is actually the key to AquaBounty’s plan to introduce GE salmon. On September 3, the FDA released a redacted copy of the environmental assessment conducted by consultants for AquaBounty revealing the company was not actually asking for approval to grow the fish in the US. Instead, they are planning to produce all the GE salmon eggs in PEI, ship the eggs to Panama for growing-out and processing and then sell “table-ready” GE salmon into the US consumer market. AquaBounty is clear its environmental assessment “is limited to specific facilities for the production of eyed-eggs on PEI and grow-out to market size in Panama.”
Environment Canada on the hook
AquaBounty does not yet have permission from Environment Canada to commercially produce GE fish eggs at its PEI facility although its entire plan currently rests on this approval. If the FDA allows the GE salmon, it will be doing so based on an assumption by AquaBounty that the company will get this permission in Canada.
Environment Canada is required to assess any request from AquaBounty within 120 days. The process is fast and involves no public participation or public hearings. In fact, the public would not even know that AquaBounty had requested this permission until Environment Canada published its final decision.
Environment Canada is new to the controversy over genetic engineering, having been denied the responsibility to regulate genetically engineered crops. Assessing the environmental risks of releasing GE plants was instead mandated to Agriculture and Agri-Food Canada via the Canadian Food Inspection Agency, with its dual mandate to promote trade as well as regulate for food safety. In the case of GE fish, the Department of Fisheries and Oceans (DFO) said for 12 years that it was developing specific regulations, but eventually abandoned these efforts. Regulatory responsibility (for GE fish and other GE animals) therefore defaulted to Environment Canada under the Canadian Environmental Protection Act (CEPA), the “safety net” that catches those products that do not have a regulatory home.
The FDA is regulating GE fish as an “animal drug” and if it approves the salmon, as VMAC member James D. McKean concluded, “the Prince Edward Island facility should be viewed as a drug manufacturing facility.” AquaBounty’s current activities in PEI, however, have not triggered an environmental assessment in Canada due to a regulatory exemption for research and development under CEPA.
GE fish gone wild
Conserving wild Atlantic salmon is a serious matter as populations dropped in Canada from about 18 million in 1975 to only 625,000 in 2008. Commercial fisheries for wild Atlantic salmon were closed in 1985 with only recreational, Labrador resident and First Nations fisheries remaining. In 2009, all populations of wild Atlantic salmon were listed in Canada as a “High Priority Candidate” in danger of disappearing, with Lake Ontario populations listed as “Extirpated” and inner Bay of Fundy populations as “Endangered.” The escape of GE Atlantic salmon from fish farms on the East Coast could therefore be a disaster for the species.
Atlantic salmon are also intensively farmed in net-pens in the Pacific Ocean, primarily in Chile and along the West Coast of Canada and the US and the escape of Atlantic salmon from either pens or hatcheries is a serious problem, representing a reoccurring environmental pollution that can also threaten native species. For example, mature escaped Atlantic salmon have been recorded in freshwater streams in BC and there is evidence of successful spawning in a few locations. To try and avoid the question of escape risk for its GE fish, AquaBounty is seeking permission to grow-out the fish in a land-based facility in a “remote highland area” of Panama, saying the facility is accessible only by a securely gated footbridge, with an entrance with locked gates, “protected by dogs.”
The FDA has announced it will conduct a new environmental assessment that will include a 30-day pubic comment period. Ultimately, the FDA may conclude the environmental risks are insignificant for the purposes of approval, but given the numerous and very serious critiques of AquaBounty’s science on health questions, the FDA will not easily get away with approving the GE salmon for human consumption.
Ten years may seem like a long time to study a product and review its safety, but that is only if those 10 years were well spent. Dr. Michael Hansen, Senior Scientist at Consumers Union in the US, testified before the Veterinary Medicine Advisory Committee on September 20, saying, “The data are too superficial and of insufficient scientific quality to warrant approval.” Having examined the summary of AquaBounty’s science, he says, “The FDA is relying on woefully inadequate data. There is sloppy science, small sample sizes and questionable practices.”
Critics have long warned that the process of genetic engineering itself could result in the increased allergenicity of foods and AquaBounty’s own data appear to confirm this potential. Additional data are clearly needed. Data from testing two small samples show there could be a risk of increased allergy potential.
The aquaculture industry in Canada and internationally says there is no market demand for the GE salmon. As Ruth Salmon, executive director of the Canadian Aquaculture Industry Alliance told CBC, “The Canadian aquaculture industry does not support the commercial production of transgenic fish for human consumption.” The aquaculture industry is right to be afraid of the GE fish. Not only is approval of GE salmon likely to scare consumers off farmed salmon, but the media attention may also highlight the existing criticisms of factory fish farming. Through this debate, for example, consumers may discover that farmed salmon are nutritionally inferior to wild Atlantic salmon, being substantially lower in beneficial omega-3 fatty acids. According to AquaBounty’s data, the GE salmon have an even lower ratio of omega-3 to omega-6 fatty acids than other farmed salmon.
Fishy Canadian research
Just like the GE “Enviropig” that came from the University of Guelph, this GE salmon is the product of publicly funded university research in Canada. Dr. Garth Fletcher from Memorial University of Newfoundland (MUN) and Dr. Choy Hew of the University of Toronto patented their gene construct for transgenic fish in 2001. As recently as January 2010, the federal government granted public funds to AquaBounty for research that can be applied to their GE salmon. The company was given $2.9 million from the Atlantic Innovation Fund to “improve the culture of reproductively sterile Atlantic salmon” with the objective of “the safe commercial launch of triploid salmon with Atlantic Canada identified as the source for associated commercial benefits, and worldwide distribution of the product.”
The Future is now – or never
AquaBounty’s transgenic salmon is in competition with the University of Guelph’s “Enviropig” to become the first GE animal introduced into our food system. “As the FDA considers its first genetically engineered food animal, we’re hopeful that this process will pave the way for future technologies currently in the pipeline,” said Jim Greenwood, president and CEO of the Biotechnology Industry Organization in a September 20 press release. “Other new technologies in development include GE cattle, goats, pigs and fish that can advance human health, mitigate environmental impact, optimize animal welfare, improve state-of-the-art industrial products and provide sustainable food sources in agriculture and aquaculture, ” Greenwood added.
However, AquaBounty’s controversial fish and the FDA’s release of its shoddy data have made the biotech industry more vulnerable than ever. Mark Walton, president of Viagen, “The Cloning Company” and Chair of the Biotechnology Industry Organization’s Animal Biotechnology Committee, told the recent Agricultural Biotechnology Industry Conference in Saskatoon that FDA staff themselves were concerned that AquaBounty would not have enough allies in the room at the September FDA hearings.
They were right.
Lucy Sharratt is the coordinator of the Canadian Biotechnology Action Network. www.cban.ca