The FDA is extending the period for interested parties to comment on the environmental assessment of the GE salmon and the preliminary Finding of No Significant Impact by an additional 60 days, to April 26.
Given that no new information has been presented, the additional delay was frustrating, said AquaBounty CEO Ronald L Stotish, PhD.
But he added: "Although we are not pleased, we do not believe this materially affects our chances for approval.
"The FDA panel of experts concluded in September 2010 that AAS is indistinguishable from other Atlantic salmon, is safe to eat and does not pose a threat to the environment under its conditions of use. There has been neither new information nor a clear legal or regulatory issue raised by the FDA since that time."
Technology enables GE salmon to mature twice as quickly as standard Atlantic salmon and consume 25% less feed
While genetically modified crops were approved for human consumption two decades ago, the 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 and consume 25% less feed - would be the first transgenic animal to gain FDA approval.
If AquaBounty gets the thumbs up, the plan is to sell eggs to aquaculture facilities inspected and approved by the FDA.
Murkowski: We have raised our voices and outrage to a level where the FDA relented
However, opponents say the GE salmon could present health risks and destroy wild salmon populations.
In a press release welcoming the extension to the comment period for the 'Frankenfish', Alaskan state senator Lisa Murkowski said: “We have raised our voices and outrage to a level where the FDA relented and is giving us more time to further lay out the case against GE salmon”.
Earlier this month, Murkowski co-sponsored two bills. The first would make it illegal to sell, possess, transport or purchase GE salmon in the US unless the National Oceanic and Atmospheric Administration concludes there is no harmful impact on the environment. The second requires that GE salmon be labeled as such.
Alaskan Congressman Don Young, has also introduced a similar bill (H.R. 584) to the House of Representatives, which would require all GE fish should be labeled as such.
FDA: GE salmon would not have a significant impact on the U.S. environment
In December, the FDA released an environmental assessment of AquaBounty’s New Animal Drug Application for AquAdvantage Salmon for public comment. 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”.
If approved, says AquaBounty, 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, it predicts.
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”, said the authors.
“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 allergenicity, 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.
Organic Consumers Association: If it escapes into the wild, it could threaten the entire wild salmon population
But the Organic Consumers Association is not convinced, and is urging consumers to sign its petition to urge the FDA to reject AquaBounty's technology.
In a statement on its website, the association asks: “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.
“If it escapes into the wild, it could threaten the entire wild salmon population.”
Two new GMO labeling bills introduced in Illinois and Iowa
Meanwhile, two new GMO labeling bills have been introduced at state level.
Senate File 194, introduced in Iowa by Senator Joe Bolkcom with the support of consumer advocacy group Food & Water Watch, would require labeling for all foods containing more than 0.9% GE ingredients; while SB 1666, introduced in Illinois by Senator Dave Koehler, would require labeling for all foods containing more than 1% GE ingredients.
The bills are the latest in a series of state-based GMO labeling initiatives including California’s Proposition 37 - which was narrowly defeated in November - and Washington State’s I-522, which has just secured enough signatures to go to the state legislature. Similar initiatives are also underway in other states, including Vermont, Missouri and Hawaii.