AquaBounty Technologies’ AquAdvantage Atlantic salmon includes a gene from the faster-growing Pacific Chinook salmon, which enables it to reach maturity twice as quickly as standard Atlantic salmon and consume less feed.

The reduced production costs meant the fish could be reared inland in tanks in the US, reducing transport costs and carbon emissions, said the firm’s chief executive Ronald Stotish.

The transgenic fish were biologically and chemically indistinguishable from standard Atlantic salmon, but simply grew faster, claimed Stotish, who was speaking to FoodNavigator-USA.com after a group of senators and congressmen wrote to the Food and Drug Administration (FDA) calling it to cease the approval process.

“The physical size of the end fish is just the same. This really is a very precise technology and a remarkably simple change. It just makes them grow faster.”

Claims flatly contradicted by the evidence

Letters to FDA commissioner Margaret Hamburg – signed by eight senators and 15 members of the House of Representatives - cite “a variety of [unspecified] concerns from potential threats to public health and the environment to the socio-economic impacts on producers of sustainable wild salmon”.

A press release by one signatory - senator Mark Begich - warns the fish could "decimate wild salmon populations" and adds: "We don’t need Frankenfish threatening our fish populations and the coastal communities that rely on them.”

But these claims were flatly contradicted by evidence made public by the FDA after a meeting of its Veterinary Medicine Advisory Committee last year, insisted Stotish, who was “pulling my hair out” waiting for the FDA to make a final decision.

As the politicians in question were well aware, he said, the transgenic salmon were sterile, exclusively-female, and unable to breed even if they did escape from enclosed, FDA-regulated facilities into the wild.

“The data is out there – although it has been ignored by all of the opposition groups – the FDA has already concluded that there is no food safety or environmental risk. But a science-based review process is being threatened by political shenanigans.” (Click here to read the FDA’s conclusions.)

The economics of salmon production

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.

“We have got a location in Panama that can rear the fish – which we set up in order to test the technology – but the plan is that we would act as a hatchery to supply the eggs to producers that would grow the fish. There are appropriate locations all over the US and we’ve had a lot of interest.”

Time consuming and unpredictable regulatory process

The next stage in the approval process is the publication by the FDA of an Environmental Assessment (based on its review of the company’s own EA document), followed by a period for public comment.

But it was anybody’s guess when this would happen, he said. “I wish I had a clear answer, but in some respects the timeline seems to be driven by concerns about liability [USDA and the EPA had faced legal challenges in relation to some GM crop approvals on “procedural” National Environmental Policy Act issues, he said].”

It was something of a miracle that investors kept the faith in many biotech firms considering how time-consuming and unpredictable the regulatory approval process was, added Stotish. “Should we fail in the US of course we will try [to gain regulatory approval in] other regions, but we wanted to start in America. We are an American company.”

FDA: No effects on wild salmon stocks

In its analysis of the AquaBounty technology published last September, the FDA said: "The food from AquAdvantage Salmon that is the subject of this application is as safe as food from conventional Atlantic salmon... In addition, no effects on stocks of wild Atlantic salmon are expected.”

In a Q&A document about the fish on its website, it also answers a question about whether its animal drug approval process is appropriate for GM fish.

It responds: “Yes. The review of the AquAdvantage Salmon, conducted under that process, includes a rigorous analysis of food safety and application of a stringent safety standard: reasonable certainty of no harm.”

As regards allergenicity, it says: “People who are allergic to Atlantic salmon will likely be allergic to AquAdvantage Salmon because it is a finfish (one of the eight most allergenic foods in the US), not because it has been genetically engineered.”