The boss of AquaBounty Technologies - which has spent years waiting for the FDA to decide whether to approve its genetically engineered (GE) salmon - says the tortuous process “has already had a chilling effect on research and investment in this field in the US”.
AquaBounty CEO Ronald L Stotish, PhD, was speaking to FoodNavigator-USA after the FDA finally released an environmental assessment of the firm’s New Animal Drug Application for AquAdvantage Salmon for public comment, more than two years after it told stakeholders in public hearings in September 2010 that the product was safe for consumers and the environment.
This found that the fish - which would have to be grown in contained facilities approved by the FDA - “would not have a significant impact on the U.S. environment”.
A number of potential customers
Stakeholders now have 60 days to comment before the FDA makes a final decision whether to approve AquAdvantage salmon, which includes a gene from the faster-growing Pacific Chinook salmon enabling it to reach maturity twice as quickly as standard Atlantic salmon.
If it gets the thumbs up, the plan is to sell eggs to aquaculture facilities inspected and approved by the FDA, said Stotish: “There are a number of potential customers waiting for the regulatory process to play itself out."
If approved, the AquAdvantage salmon would be the first genetically engineered animal allowed for human consumption.
Tortuous regulatory process likely to put off all but the most patient, and wealthy, biotech investors
However, the regulatory process for approving genetically engineered animals for human consumption is likely to put off all but the most patient, and wealthy, firms in future, predicted Stotish, who warned that further delays could cripple the company.
“AquaBounty is in the process of raising money. If they don’t succeed, the company will not survive. It is completely correct to assume that the inexplicable regulatory delays would have killed the company.”
He added: “We hope that the science based regulatory process will continue so that we can continue to keep things running.”
Opponents have consistently and intentionally misrepresented the facts
Asked why he believed some consumer advocacy groups are so vehemently opposed to the technology, despite the fact that it could potentially reduce pressure on stressed wild fish stocks and generate a lower carbon footprint (the GE fish require less feed to reach maturity and can be bred close to market), he said:
“It seems these groups object to the use of modern food technology in general - even when shown to be safe.
“In our case, they have consistently and intentionally misrepresented the facts - even when asked in writing by scientists to discontinue misrepresenting [the technology].
“They seem to want to frighten the public to pressure politicians and prevent adoption of new technologies... They also appear to oppose us because we are the pioneer, and if they stop us they may prevent future applications.”
Is opposition politically or economically motivated?
AquAdvantage salmon are biologically and chemically indistinguishable from standard Atlantic salmon, they just grow faster, claimed Stotish, who told us last year that a lot of the opposition was politically or economically motivated.
He added: “Some [critics] just have an issue with the technology, but others have been quite candid that their concern is about the price of Alaskan salmon. An economic argument is one thing, but to masquerade your [economically-motivated] opposition as a food safety or environmental issue is at best disingenuous but arguably much worse.”
If approved, he claimed, the AquAdvantage salmon would compete with farm-raised Atlantic salmon, which was imported from all over the world.
Alaskan wild salmon meanwhile, was competing in a different market, and would continue to command a premium price, he predicted.
FDA: If you‘re allergic to Atlantic salmon, you’ll be allergic to AquAdvantage salmon
However, opponents continue to argue that the GE salmon could present “serious health risks” and “decimate wild salmon populations”, claims flatly rejected by animal scientists William M. Muir and Alison L. Van Eenennaam in a commentary published in Nature Biotechnology last August.
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 claim.
“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% 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.”
As regards allergens, the FDA has made it clear that people who are allergic to Atlantic salmon will likely be allergic to AquAdvantage salmon because it is a finfish, not because it has been genetically engineered, they observed.
Alliance for Natural Health USA: Escaped fish could wreak havoc on the ecosystem and our already-threatened wild salmon populations
But the Organic Consumers Association remains unconvinced, and is urging consumers to sign its petition to urge the FDA to reject AquaBounty's technology.
In a statement on its website published after the FDA released the environmental assessment, the association asked: “Do you really want a mutant, likely allergenic salmon on your dinner plate …. mounting concerns that it's likely hazardous for humans and poses a threat to the wild salmon population?"
The Alliance for Natural Health USA also criticized the Environmental Assessment, which it says "fails to mention the fact that up to 5% of the fish may be fertile, when we were assured they would all be sterile. The genetically engineered fish could easily escape into local waterways and wreak havoc on the ecosystem and our already-threatened wild salmon populations."
Wenonah Hauter, executive director of Food & Water Watch, said: “To add insult to injury, this product may be hitting the market without labeling, meaning that concerned consumers who have demanded labeling will be unable to identify GE from non-GE salmon.”