Touting a paper in the Food and Drug Law Institute’s (FDLI) Food and Drug Policy Forum, AquaBounty Technologies of Maynard, Mass., on Wednesday questioned the role of politics in the U.S. Food and Drug Administration’s (FDA) approval process for its genetically modified (GM) Atlantic salmon.
“The delay associated with our approval has damaged the credibility of the FDA as an independent science-based regulatory agency,” said Ronald Stotish, CEO of AquaBounty, in a statement. “The influence of politicians and those philosophically opposed to biotechnology on what is supposed to be an evidence-based process is creating an environment of ‘regulation by referendum’ — a disservice to the health and safety of the American people.”
The FDLI point-counterpoint document, dated 24 July, included one half penned by Food & Water Watch Senior Researcher Tim Schwab and the other by a team of scientists that AquaBounty says have “longstanding relationships” with the food-safety agency.
Schwab argued that, should the FDA approve GM salmon for commercial sale, it would set a precedent for how rigorously the agency will assess biotech food animals. Its approval would, he wrote, “establish a dangerously lax legal and regulatory precedent for a whole new era of biotech animals, whose potential risks to consumer health, animal health, the environment and the economy will not be meaningfully examined by FDA prior to commercialization.” The title of his report is “Is FDA Ready to Regulate the World’s First Biotech Food Animal?”
In contrast, the team of scientists, headed by Alison Van Eenennaam, Ph.D., University of California-Davis, said the process FDA is using to regulate products from GM animals is overly rigorous, far beyond the legally required scientific analysis of food and environmental safety. No product could withstand this level of “non-science-based scrutiny,” according to the paper.
“Science is the basis for the FDA’s considerations of all products… Lacking the background to interpret the science associated with GE (genetically engineered) animals as presented, activists often offer biased interpretations of the data and criticize the process by which the regulatory decision making goes forward,” stated the counterpoint paper, titled “Is Unaccountable Regulatory Delay and Political Interference Undermining the FDA and Hurting American Competitiveness?”
Van Eenennaam, a member of FDA’s Veterinary Medicine Animal Committee, the independent body of experts that reviews applications at the request of the agency’s Center for Veterinary Medicine, was joined by William Muir, Ph.D., a professor of animal science at Purdue University, and Eric Hallerman, professor of wildlife and fisheries at Virginia Tech University. Muir and Hallerman reviewed the data and both presented at the public FDA Forum on the AquaBounty application.
The authors echoed the FDA’s findings that fish grown from AquaBounty’s AquAdvantage® Salmon eggs are “as safe as food from conventional salmon” and that the fish “will not have any significant impacts on the quality of the human environment of the United States … when grown and produced under the conditions of use for the proposed action.”
They also criticized elected officials, most notably Rep. Don Young (R-Alaska), who criticize agency actions “on the basis of perceived risks to narrow constituencies. Regulatory actions should be based exclusively on science.”
Food & Water Watch, a non-profit organization known to be opposed to biotechnology, maintains that all foods derived from GM animals should have mandatory labeling to “entitle consumers to a choice in the marketplace.”
For more on the GM salmon issue, look for the September issue of SeaFood Business. To download a pdf copy of the document, click here.
