'Few technologies could survive' flawed GM salmon review process, warns ex FDA panel member

By Elaine Watson

- Last updated on GMT

Related tags Salmon

Farmed GM fish could ease pressure on wild fish stocks, argue animal scientists
Farmed GM fish could ease pressure on wild fish stocks, argue animal scientists
A former member of the government committee charged with assessing the safety of the first genetically engineered (GE) fish for human consumption says “few, if any technologies could survive” the flawed review process.

In a commentary published in Nature Biotechnology​ (online), animal scientists William M. Muir and Alison L. Van Eenennaam argue that assessing the risks of new food technologies without also considering any benefits - or indeed risks associated with not​ approving them and sticking with existing food production systems – was both unfair and unscientific.

Muir, a professor of animal sciences at Purdue University, served on the Food and Drug Administration's (FDA's) Veterinary Medicine Advisory Committee, while Dr Van Eenennaam is an animal genomics and biotechnology specialist at the University of California, Davis.

No significant difference in cancer hormone levels

Their commentary follows a recent amendment to the Agriculture Appropriations Bill (HR2112) proposed by Congressman Don Young that would prevent the FDA from spending appropriated funds to finalize its review of the fish.

AquaBounty Technologies’ AquAdvantage Atlantic salmon, which include a gene from the faster-growing Pacific Chinook salmon enabling them to reach maturity twice as quickly as standard Atlantic salmon, could lower carbon emissions as they could be produced closer to market and consumed less food, they claim.

Yet opponents continue to argue that they could present “serious health risks​” and “decimate wild salmon populations​”, despite all scientific evidence to the contrary, claim the authors.

Should the sterile and exclusively-female fish escape from enclosed FDA-regulated facilities into the wild, the data showed they were poorly equipped to multiply, they add.

“The’ Trojan gene effect’ would not be predicted to occur in the unlikely event AquAdvantage salmon did escape from confinement. Rather, selection over time would be expected to simply purge the transgene from any established population...”

As for food safety risks: “Another … allegation was the suggestion that AquAdvantage salmon had 40 percent more IGF-1, a hormone linked to prostate, breast and colon cancers in humans… In fact, the data … showed there was no significant difference between the mean IGF-1 levels for the GE and non-GE diploid salmon.”

Excessive regulatory burden?

By focusing exclusively on risks, however, the FDA review process was almost doomed to fail, conclude the authors: “Few, if any technologies could survive a risk-only analysis."

It was also important to recognize that the alternative was more risky, as wild-caught salmon did "not present a long-term, ecologically sustainable solution to rising global fish demand",​ they added.

“One of the benefits associated with the development of GE fish for aquaculture may well be helping to reduce recognized pressure on wild fish populations.”

Yet these factors were not taken into account in the review process: “The regulatory process associated with GE animals focuses on risks with little consideration of attendant benefits. And paradoxically, similar risks known to be engendered by conventionally bred animals (fish selected to grow faster, outcompeting wild stocks) undergo no regulatory scrutiny.

“Subjecting conventionally bred and GE animals to different regulatory standards is inconsistent from a scientific perspective and places an excessive regulatory burden on the development of GE technologies.”

A cautionary tale for investors …

Most depressingly, AquaBounty’s experience was likely to put off all but the most patient – and fabulously wealthy – investors in GE animals in future, they predicted.

“This could jeopardize future access to improved genetic lines resulting from new technological developments (e.g., disease- resistant GE animals), with negative consequences on food security and other broadly supported societal goals, including improved human and animal health.”

Speaking to FoodNavigator-USA following the publication of the commentary, Van Eenennaam said the "unpredictable timeframe threatens the commercial viability of developing genetically engineered animals for food purposes.

"What is problematic is that AquaBounty has provided the FDA with all of the data requested and at a September 2010 public meeting the FDA reported it had found the AqaAdvantage salmon to be as safe as farm-raised, conventionally-bred salmon, and that the ‘drug’ was effective - ie, the fish grew faster.

“It is now almost one year later and it is uncertain the status of the application. The company has not been asked to provide additional data and from its perspective the absence of a decision must be difficult to explain to investors"

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Precautionary principle

Posted by WD Mindock,

No long term independent study has ever shown GE food to be safe. Things like sterility, lesions, tumors, and premature death have been demonstrated over and over.

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Something overlooked, as usual

Posted by W D Windlan,

Why does the question about the safety of the consumer not enter the picture? AFAIK, no independent study, long term over a couple generations, has ever found GE food to not to cause serious problems: sterility, premature death, tumors. This is always swept under the rug. This is huge disregard, not only of the precautionary principle, but of sanity and ethics.

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Something fishy about this report

Posted by Jennifer Christiano,

Just because we CAN, does not mean we SHOULD. Oh, and if we're so concerned about wild fish stocks and world hunger, perhaps we should stop feeding wild-caught fish to pigs and farmed fish. The developed world consumes far too much protein - a reduction would be good for us. The solutions to world hunger are eating lower on the food chain, and supporting women's rights and family planning. But of course, manging people isn't like managing rats or robots in a lab, so few scientists will admit that their "solutions" are really irrelevant.

By the way, is the purpose of the FDA to protect public and environmental safety, or to protect the pocketbooks of whoever chooses to create new forms of life for profit? The arguments of the researchers bleeding for the fate of GE fish (and all the starving children, of course), are weak and don't answer a variety of basic questions, at least according to the article. A fundamental issue that is soundly ignored is gene flow, as opposed to organismal flow. We know that escapes will happen from time to time, and that's bad enough, but GENE flow is almost impossible to eliminate or even trace. And when the inevitable problems rear their ugly heads, WHO is going to take responsibility? I can assure you, theose cheerleading for GE foods are going to disappear from the scene like rats streaming from a sinking ship when the time comes to pay the piper.

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