News in brief

AquaBounty posts $3.5m loss in first half, says 'no scientific reason' why FDA shouldn't give GE salmon the green light

AquaBounty's GE salmon present the opportunity for a new, more sustainable fish farming business that will create American jobs and reduce dependence on imported Atlantic salmon, says CEO Dr Ron Stotish

AquaBounty Technologies - which is hoping to become the first company to introduce a genetically engineered (GE) animal to the human food supply - posted net losses of $3.5m in the six months to June 30, up from a loss of $2.1m in the first half of 2013.

However, the firm - which has been stuck in regulatory limbo for years as the FDA mulls over its technology - says it has enough cash to keep funding its operations after majority shareholder Intrexon Corporation agreed to undertake a subscription for new common shares of $10m in January.

AIM-listed AquaBounty, which is also preparing to list on NASDAQ, says it expects its AquAdvantage genetically engineered salmon (AAS) to gain regulatory approval this year.

The salmon contains a growth hormone gene from the faster-growing Chinook salmon that is effectively ‘turned on’ all year round instead of only during the warmer months, halving the time it takes to reach maturity.     

More sustainable fish production that will reduce US dependence on imported Atlantic salmon

CEO Dr Ron Stotish said: "The Board knows of no scientific reason why the FDA has not given approval to AAS. It continues to believe that approval will be granted this year and has commenced preparations for commercialization of AAS.

"AquAdvantage Salmon presents the opportunity for a new and sustainable fish farming business that will create American jobs and reduce US dependence upon imported Atlantic salmon. We look forward to making this possible."

Regulatory limbo

Last November, Environment Canada concluded the AquAdvantage salmon are not harmful to the environment or human health when produced in contained facilities, following a risk assessment by Fisheries and Oceans Canada.

However, for the eggs and fish to be approved for sale in the US and Canada, AquaBounty still needs final regulatory approvals from the FDA and Health Canada.

So far, the only approved growing facility for the fish is operated by AquaBounty in Panama. However, if the FDA gives the technology the green light, several partners are poised to set up facilities in other locations in which to grow the fish, each of which would require FDA approval on a case-by-case basis.

In the meantime, the list of retailers that have pledged not to stock the salmon should it get the regulatory green light is rising, and now includes Kroger, Safeway, Target, Whole Foods and Trader Joe’s.  

Is the FDA’s review process for genetically engineered animals fit for purpose?

AquaBounty first submitted its investigational new animal drug application in 1995 and has still not had a ‘yes’ or a ‘no’ from the FDA - which gave it the provisional thumbs up in 2010, noted Dr Alison Van Eenennaam, who works in the department of animal science at the University of California, Davis.

Speaking to FoodNavigator-USA at the IFT show last year, Dr Van Eenennaam said that AquaBounty's experience is likely to put off all but the most patient – and fabulously wealthy – investors in GE animals in future, which was depressing as the fish offered sustainability benefits because they get to market faster, eat less and could be grown in domestic facilities, she said.

Click HERE for some perspective from supporters and opponents of the technology.

Related News

Scientists to Obama: AquaBounty's experience gives 'credence to those who publicly contend FDA regulation is based on politics and public opinion rather than science'

Regulatory roadblocks to AquaBounty's GE salmon ‘seriously damage the global credibility of FDA and its objective, science-based approval process’, warn scientists

The Ecology Action Center claims GE salmon could cause 'irreversible genetic contamination' of wild salmon populations, a claim AquaBounty rejects

AquaBounty: Lawsuit just another attempt to delay commercialization of GE salmon

Trigger for review of GE animals should be the novelty of the introduced traits, not the process that creates them, says biotech expert

Trigger for review of GE animals should be the novelty of the introduced traits, not the process that creates them, says biotech expert

The hurdles faced by GM salmon expert AquaBounty have had a "chilling effect upon the development and commercial adoption of GE animals more generally", claim scientists

GE salmon... Is the FDA’s review process for genetically engineered animals fit for purpose?

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