FDA hearings into AquaBounty's genetically engineered salmon, AquaAdvantage got underway Monday in New York. One scientist has said he will be testifying at the hearing about the 'sloppy science' involved in the FDA approval process.
Should the AquAdvantage Salmon be approved as a food, it will be the first genetically engineered animal on the market. Originally created by Canadian scientists, the fish is an Atlantic salmon that has the genes of a Chinook salmon, as well as a species of eel that allow the transgenic fish to grow faster than it would naturally. Some have dubbed the salmon ''frankenfish.'
The genetically modified salmon is close to receiving approval to be sold to shoppers in American supermarkets after being considered for ten years by the United States Food and Drug Administration (FDA). But while approval for the technologically engineered animal is close, there are dissenters who say the FDA did not use rigorous qualifications when it began to evaluate the salmon.
One dissenter is a scientist from the US Consumer's Union. In a press release, Dr. Michael Hansen said “FDA should be especially cognizant of the scientific quality of the data and the rigor of the analysis needed to do a proper safety assessment of GE animals in this case, since it is the first genetically engineered animal FDA has had to consider. Unfortunately, the evidence of FDA’s evaluation of the AquAdvantage salmon suggests that FDA has set the bar very low. This analysis does not conform to FDA standard for assessment of a New Animal Drug (NAD).”
Hansen was to testify Monday in the two-day public hearing into the salmon being conducted by the Veterinary Medicine Advisory Committee (VMAC). Hansen is critical of the process the FDA has followed in assessing the fish, saying “The FDA is relying on woefully inadequate data. There is sloppy science, small sample sizes, and questionable practices."
Hansen also pointed out a previously unaddressed issue with the fish, said CBAN in a press release issued Monday. "AquaBounty's own data, although incomplete, do raise a potential serious human health issue – that of increased allergenicity."
The Council of Canadians issued a press release last week stating that AquaBounty would seek permission from the Canadian government "... to commercially produce genetically engineered (GE) fish eggs" at a Prince Edward Island facility owned by AquaBounty. The eggs would then be sent to Panama, where the fish would be cultivated for market. When market-ready, the fish will be sold in the United States. The Council is monitoring the proceedings closely.
The FDA is withholding approval of the salmon until after the public hearings, although the organization has already determined the technology is safe. Once the hearing wraps up in Maryland late Tuesday, the FDA will be looking into labelling of the fish if it is approved for sale to consumers. Those who are interested will have an opportunity to comment on labelling requirements up to November 22, said spokesperson for the FDA, Sihobhan DeLancey.
Delancey stressed approval of the GE salmon has not been granted. "The FDA has not issued any approval. The analyses posted on our web site are preliminary conclusions and do not consitute an approval. We look forward to the comments from the public and the discussion from the Veterinary Medicine Advisory Committee to aid in our review."
That is small comfort to scientists like Henson, who said the FDA's initial approval is not based on solid science. Hensen is concerned about research of the trangenetic salmon's growth hormones, stating “... two different studies were evaluated and both were deficient. The first study of growth hormone levels examined fish that weighed just 2 ounces instead of using 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. Yet the FDA concluded from these studies that there is “no biologically relevant difference” when it comes to the levels of growth hormone in the GE fish compared to the non-GE fish."
AquaBounty, in the meanwhile, anticipating good news from the FDA, is already pushing ahead with commercialization. In a press release, Ronald Stotish, AquaBounty's Chief Executive Officer said “We are pleased that AAS is nearing the end of the FDA approval process and we anticipate receiving formal approval before the year end. As a result, our attention now is on meeting the production and commercialization challenges for this exciting new product.”
AquaBounty is also working on transgenic Tilapia and Trout. The company says it is a leader in the field of aquaculture, and claims "... The salmon AquAdvantage® Salmon (AAS) reach market size twice as fast as traditional salmon. This advancement provides a compelling economic benefit to farmers (reduced growing cycle) as well as enhancing the economic viability of inland operations, thereby diminishing the need for ocean pens. AAS are also reproductively sterile, which eliminates the threat of interbreeding amongst themselves or with native populations, a major recent concern in dealing with fish escaping from salmon farms."
The company has been hemorrhaging money over the past ten years, and decided to focus on getting the AquaAdvantage Salmon to market in an attempt to stop up the loss of multiple millions of dollars.
AquaBounty was the recipient of a grant from the Canadian Atlantic Innovation Fund to produce sterile salmon. The government of Canada announced the funding in early 2009. The government awarded AquaBounty Canada with $2.9 million.
Hearings on labelling requirements for the GMO fish begin Tuesday.
Correction: Please note the article originally said the VMCA hearing was taking place in New York, which was erroneous. The article has been corrected, and the author apologizes for any confusion she might have caused. Also the title was amended to say 'evaluation' instead of the original 'approval,' which is erroneous.