May 25, 2013
Biotech Gets Fishy with GE Salmon
An abbreviated version of this article was published in Common Ground Magazine, October 2010. Lucy Sharratt is the coordinator of the Canadian Biotechnology Action Network.
Some say genetic engineering was always fishy, but now the fish themselves are engineered.
For 15 years genetically engineered (GE, also called genetically modified or GM) canola, corn, and soy ingredients (and recently, some GE sugar) proliferated in processed foods in North America. (www.cban.ca/gefoods) Now salmon is the next genetically engineered food that threatens to be introduced to 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 ask for approval soon in Canada as well. The company claims its “AquAdvantage” salmon grow to market-size twice as fast as other farmed salmon. That’s because the 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 just for 3 months as they would normally.
After ten years of consideration, the US government is about to approve the GE salmon. Or are they? On August 25, the U.S Food and Drug Administration (FDA) announced the final stages of its process to approve the GE salmon. The FDA called on their 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 the 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. The FDA did not ask the VMAC for an overall recommendation but is now left to consider the fact that questions were raised and virtually no one answered yes to the question “Do the data and information demonstrate a reasonable certainty of no harm from consumption of foods derived from AquAdvantage salmon?”
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 on 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 on 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.”
But while the FDA is busy assessing the PEI-Panama production plan, AquaBounty is selling a completely different story to the American public. Even recently, including at the VMAC hearings, AquaBounty’s CEO Ron Stotish restated the company's vision for raising fish closer to mainland consuming populations in the US. FDA official Larissa Rudenko had to intervene and remind the committee that the application before them only relates to production in Canada and Panama. Stotish's comments give credence to warnings from US groups that the company does not intend to stick to its original production plan, but will expand and shift its production of GE fish to other countries and conditions as soon as it can.
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 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 on PEI however have not triggered an environmental assessment in Canada due to a CEPA regulatory exemption for research and development.
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 resulting in reoccurring environmental pollution that can threaten native species. For example, mature escaped Atlantic salmon have been recorded in freshwater streams in British Columbia and there is evidence of successful spawning in a few locations. To try and avoid the question of escape risk for their GE fish, AquaBounty is seeking permission to grow-out the fish in a land-based facility in a “remote highland area” of Panama. The company says the facility is accessible only by a securely gated footbridge, has an entrance with locked gates, and is “protected by dogs.”
The other primary containment strategy being relied on is the company’s plan to only produce female fish that are triploid, meaning they will not be able to reproduce. AquaBounty concedes that up to 5% of the salmon could still be fertile at any given time but concludes that, “the production, grow-out, and disposal of AquAdvantage Salmon under the conditions described in this Environmental Assessment are highly unlikely to cause any significant effects on the environment”. This includes their plan for shipping the GE fish eggs from PEI to Panama using a “rugged” Styrofoam egg crate packed in a hard-plastic “Igloo” cooler bound with packing straps and further secured in a heavy-cardboard shipping container.
The FDA has announced that it will conduct a new environmental assessment that will include a 30-day pubic comment period. Ultimately, the FDA may conclude that 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.
Risky Fish Fingers
Ten years may seem like a long time to study a product and review its safety, but that is only if those ten 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. More data are clearly needed. Data from testing two small samples show that there could be a risk of increased allergy potential. The problem of small sample sizes and questionable design characterizes AquaBounty’s study on this health question. As VMAC member Robert H. Poppenga of the Animal Health and Food Safety Lab at the School of Veterinary Medicine, University of California, told the FDA meeting, "I can't interpret the allergenicity data that's there." The company maintains however that its GE fish are “substantially equivalent to farmed salmon.”
Among other specific problems, the two studies to look at potential risks from elevated growth hormone levels were deficient. The first of these examined fish that weighed just 2 ounces, instead of market-sized fish. The second study used market-sized fish, but the sensitivity test method was so high that it did not detect growth hormone in any of the GE or non-GE sample fish. The company similarly used insensitive tests to look for levels of IGF-1, a hormone linked to a number of cancers. This means that the FDA currently has no real data to make conclusions on these safety questions.
The aquaculture industry in Canada and internationally says there is no market demand for the GE salmon and, 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 stated.
AquaBounty’s controversial fish and the FDA’s release of its shoddy data have, however, 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 Policy 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.