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"