Frankenfish Flops Risk Assessment

A recently released Canadian document may have thrown a monkey-wrench into U.S. Food and Drug Administration (FDA) plans to finally approve a genetically-engineered salmon (known in some circles as the “Frankenfish”) for human consumption. The trademarked AquAdvantage Salmon, developed in Canada by Massachusetts-based AquaBounty Technologies, has been opposed by environmentalists, wild fisheries proponents, consumer advocacy organizations and others on both sides of the Canada-U.S. border for years.

During the lengthy U.S. federal review process, the FDA in December 2012 released an environmental assessment finding of “no significant impact,” the last step required before making a final decision. The extended public comment period following that assessment resulted in nearly two million responses, which the FDA has been reviewing ever since.

By September 2014, 90 scientists wrote to President Obama, urging him to press the FDA into making a decision, claiming that “obvious regulatory roadblocks…not only undermine our ability to meet the future food needs of the world, but seriously damage the global credibility of FDA and its objective, science-based approval process…” [1]

Now, a different and never-before-seen draft environmental risk assessment of the AquAdvantage Salmon reveals that Canadian government scientists found significant problems with the fish, including increased susceptibility to disease and widely inconsistent growth rates. As a result of this newly released draft risk assessment, U.S. NGOs are calling for the U.S. FDA to stop its own review of the fish.

A May 28 news release from Food & Water Watch, the Center for Food Safety, Friends of the Earth, and the Consumers Union called for the FDA to “terminate its ongoing review of GE salmon.” [2] As Wenonah Hauter of Food & Water Watch stated, “The findings from the Canadian risk assessment show that FDA has based its assessment of this totally unnecessary technology on blind trust.” The draft risk assessment revealed “unique safety issues that FDA has failed to consider, which is why we are calling on the agency to terminate its review,” she said.

The CEO of the American company, Ron Stotish, told the CBC in November 2013 that AquaBounty would not scale up commercial production in Canada unless the FDA gives the company approval to sell its GE salmon in the U.S. [3]

Growth Factor

The lobbyists for the GE salmon have always touted its “fast growth” as the primary benefit of its product. AquaBounty Technologies genetically-engineers the salmon by splicing the genetic material of Chinook salmon and ocean pout (an eel-like marine fish) with Atlantic salmon DNA, in order to create a species of salmon that purportedly grows more rapidly in fish-farms. According to PR Watch, “The new genes make the GE salmon produce growth hormone all year round instead of just for three months a year as they normally would. This helps them grow to market size in 16 to 18 months instead of the usual 30 months required for an Atlantic salmon.” [4] Such a feature could make the GE fish an appealing choice for salmon fish-farms worldwide.

But the July 2013 Canadian draft risk review, prepared by the Office of Aquatic Biotechnology in the Department of Fisheries and Oceans Canada (DFO), found dramatically diminished and highly inconsistent growth rates in the fish. [5] Food & Water Watch states that this “widely varied [growth] performance” suggests “that the growth-hormone gene construct inserted in the fish is not operating in a predictable manner, raising questions about the durability, safety and commercial viability of GE salmon.”

This is especially pertinent because – as the Toronto Star noted five years ago – this first Frankenfish “has a slightly elevated level of ‘insulin-like growth factor 1,’ a hormone related to growth hormone that has been linked in some studies with higher cancer risk.” [6]

Moreover, if the genetic modification is not producing consistent results in the actual fish, then (as a Natural News staff writer recently stated) this may be “evidence of shoddy genetic engineering,” raising “serious concerns…” [7] According to FDA requirements, a genetically-engineered animal must exhibit a durable genetic phenotype and genotype that are stably inherited and predictable over subsequent generations. [8]

Disease Susceptibility

In their ten-page, May 28 letter to Dr. Stephen Ostroff, Acting Commissioner of the FDA, the NGOs also raise concerns about the AquAdvantage Salmon’s susceptibility to disease, as determined by the Canadian scientists. Their letter states: “DFO scientists concluded with ‘reasonable certainty that [AquAdvantage Salmon] is more susceptible to A. salmonicida than domesticated comparators…’ Aeromonas salmonicida is a bacteria that causes furunculosis in salmon, which can be treated with several antibiotics approved by FDA. The use of antibiotics to treat furunculosis in salmon aquaculture has already led to the emergence of antibiotic-resistance bacteria.” [9]

As well, “The DFO review also noted ‘it is highly certain that [AquAdvantage Salmon] is highly susceptible to ISAV [infectious salmon anemia virus]’ and that ‘we have no data on the relative susceptibility of [AquAdvantage Salmon] to other disease agents of environmental significance [compared to wild Atlantic salmon]’.”

ISAV and other diseases can rapidly develop in the crowded conditions of open-net pen salmon fish-farms located in ocean sites, leading to millions of dollars in corporate losses (usually covered by the taxpayer, as in Canada) and endangering wild fish forced to migrate past the fish-farms. [10]

AquaBounty’s Canadian facility in Prince Edward Island (PEI) has had several disease outbreaks, including an ISAV outbreak in 2009. Nonetheless, according to the May 28 NGO letter, the U.S. FDA has made a “favorable risk-asseessment” about the GE salmon, “asserting that the agency ‘found no evidence that AquAdvantage Salmon have any altered resistance to disease or parasites’.” The NGO letter further states: “That scientific evidence has emerged challenging FDA’s assertions about disease resistance is a wholly predictable consequence of the agency’s head-in-the-sand approach to risk assessment through its environmental assessment.”

“Government Secrecy”

The fact that this draft Canadian risk assessment document has even emerged into the light of day is somewhat remarkable, given that the right-wing conservative government of Prime Minister Stephen Harper has long treated the GE salmon issue as “top secret.” For months, Canadian environmentalists could not even get an answer as to whether or not the GE salmon was actually undergoing any environmental assessment in Canada.

Back in 2010, after AquaBounty had first asked the U.S. FDA to approve the GE salmon for human consumption, activists in PEI (where the hatchery is located) questioned all the secrecy in Canada. “It’s ridiculous that Environment Canada refuses to even tell the public if it’s conducting an environmental assessment. Why is this top secret? And why is there no public input? And why is the province excluded in the process,” asked Sharon Labchuk of Earth Action PEI. [11]

According to a November 22, 2010 press release from the Canadian Biotechnology Action Network (CBAN), “Environment Canada will assess the environmental risks of commercial scale GE salmon egg production in a completely secret process. The department must reach its decision in120 days of receiving a request [from industry]. Environment Canada will regulate GE fish or fish eggs under the Canadian Environmental Protection Act because the Department of Fisheries and Oceans [DFO] abandoned development of regulations for Transgenic Aquatic Organisms.” [12]

Three years later, in late November of 2013 (five months after the internal DFO draft risk assessment was written), Environment Canada quietly announced that it had granted AquaBounty Technologies permission to develop and export up to 100,000 GE salmon fish eggs per year from its hatchery in PEI to a site in Panama where they are grown to full size. [13] The Canadian approval prompted AquaBounty CEO Ron Stotish to tell the CBC: “I think there’s a simple choice here. Are you going to believe the professionals, the skilled scientists, or the people that are constantly beating the drum that there is some sort of conspiracy between the government and industry to somehow damage the environment?” [14]

The announcement also prompted legal action by two Canadian NGOs: The Ecology Action Centre and Living Oceans Society. In December 2013, they launched a lawsuit against the Ministers of Environment Canada and Health Canada, as well as AquaBounty Canada Inc., asking the Federal Court to decide if the Canadian government had violated its own law when it permitted the manufacture of GE salmon to proceed.

For many months, however, the Canadian government simply refused to provide information and documents relevant to the legal case, including any documents on which its decisions were based. This clever stonewalling meant that the case could not move forward in court. As well, Health Canada consistently refused to confirm or deny that AquaBounty had made any application for approval to sell the GE fish in Canada.

But in March 2014, CBAN discovered an investment filing at the London Stock Exchange which confirmed that AquaBounty was seeking approval for human consumption of its GE fish in Canada. [15]

As Karen Wristen, executive director of Living Oceans Society, told the press in March 2014, “Every aspect of the assessment of this [genetically-modified] salmon has been shrouded in government secrecy. We’re going to continue to fight this case, and to challenge Canada’s lack of transparency and denial of public scrutiny.”[16]

After being denied information from the federal government’s lawyer, Living Oceans Society filed requests through the Access to Information Act. Finally, just weeks ago, the federal government provided documents pertinent to the legal case – including the 2013 draft risk assessment conducted by DFO. According to Wristen, the 400-page document “was heavily redacted before being handed over to the court.” [17]

Nonetheless, the document has helped U.S. NGOs to now challenge the ongoing U.S. FDA review, and it will be part of the legal challenge to the Canadian federal government’s approval of GE salmon, given that the Frankenfish apparently flopped the government’s own draft assessment in some categories of risk. On May 5, Ecojustice lawyers representing Living Oceans Society and the Ecology Action Centre filed their evidence in the case, which will now move forward in Canada’s Federal Court.

All Risk/No Reward?

Dana Perls, food and technology campaigner for Friends of the Earth, recently told the press, “Major grocery chains, consumers and salmon producers are all rejecting genetically engineered salmon. This new assessment adds to the body of science showing that this genetically engineered fish doesn’t offer any benefit to aquaculture, has unique health problems and presents environmental risks. Why is the FDA continuing to spend scarce tax-payer dollars reviewing this fish that offers all risk and no reward?” [18]

Consumers Union senior scientist Michael Hansen may have found the answer. Two years ago Hansen stated that the quality of the scientific data submitted to the U.S. FDA by AquaBounty Technologies was “the worst stuff I’ve ever seen submitted for a GMO. There’s stuff there that couldn’t make it through a high school science class.” [19]

Hansen warned, “If they [the U.S. FDA] let the GE salmon go through, why would any other company that wants to get a genetically engineered animal through [the regulatory system] bother” to produce rigorous and valid scientific data proving its product’s safety?

Hansen called the company’s data “a joke,” but if this Frankenfish ends up in fish-farms and then grocery stores, it will be no laughing matter. The AquAdvantage Salmon is the first of several genetically-engineered fish (including trout, catfish, tilapia, cod) and a host of other genetically-modified animals being developed by the biotech industry for eventual human consumption. As Hansen put it, approving the GE salmon on the basis of obviously shoddy science would “set a precedent,” one that the industry is waiting for.

Joyce Nelson is an award-winning Canadian freelance writer/researcher working on her sixth book.


[1] http://www.foodnavigator-usa.com/content/view/print/968769

[2] Food & Water Watch, “Canadian Risk Assessment Finds GMO Salmon Susceptible to Disease,” May 28, 2015.

[3] CBC News, “GMO salmon criticisms ‘don’t merit comment’,” Nov. 27, 2013.

[4] PR Watch, “FDA Ready to Approve Frankenfish Despite Fishy Science,” March 19, 2013.

[5] “Environmental and Indirect Human Health Risk Assessment of the AquAdvantage Salmon: Draft In Revision,” Office of Aquatic Biotechnology, Department of Fisheries and Oceans Canada, July 2, 2013.

[6] David Olive, “Olive: A fish story that’s tough to believe,” The Toronto Star, Sept. 7, 2010.

[7] David Gutierrez, “GM salmon susceptible to disease, slow growth, GMO scientists alarmed that biotech is unpredictable,” Natural News, June 6, 2015.

[8] May 28, 2015 Letter to Dr. Stephen Ostroff, Acting Commissioner, U.S. Food and Drug Administration, from Food & Water Watch, Center for Food Safety, Friends of the Earth.

[9] Ibid.

[10] Briony Penn, “BC’s Expensive Fish Farms,” Watershed Sentinel, Summer 2015.

[11] Canadian Biotechnology Action Network, “PEI Groups request Premier Ghize to press Environment Canada for disclosure on GE Salomon,” November 22, 2010.

[12] Ibid.

[13] Suzanne Goldenberg, “Canada approves production of GM salmon eggs on commercial scale,” The Guardian, November 25, 2013.

[14] CBC News, “GMO salmon criticisms ‘don’t merit comment’,” November 27, 2013.

[15] Ecology Action Centre and Living Oceans Society, “Genetically Modified Salmon Court Case Prompts Federal Government to Publish Vague Notice of Waiver for Toxicity Information,” March 13, 2014.

[16] Ibid.

[17] Living Oceans Society, “World’s first genetically modified food animal approval proceeds to trial,” May 5, 2015.

[18] David Gutierrez, “GM salmon susceptible to disease, slow growth, GMO scientists alarmed that biotech is unpredictable,” Natural News, June 6, 2015.

[19] PR Watch, “FDA Ready to Approve Frankenfish Despite Fishy Science,” March 19, 2013.

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Joyce Nelson’s sixth book, Beyond Banksters: Resisting the New Feudalism, can be ordered at: http://watershedsentinel.ca/banksters. She can be reached through www.joycenelson.ca.

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