The U.S. government is a step closer to approving the first genetically engineered animal, an Atlantic salmon produced by AquaBounty, for human consumption.

On Dec. 20, 2012, the FDA released a draft assessment concluding that AquaBounty’s application to farm and market the salmon – which grow twice as fast as normal -- does not pose major worries for the environment.

Read the FDA draft environmental assessment or comment here.

Now in the midst of a 60-day comment period, those opposed to the GE salmon have continued to complain about a myriad of issues surrounding the regulatory system. Also in the mix are lawmakers from states where commercial salmon would face competition from their GE cousins.

Initially, AquaBounty plans to prepare eggs from the salmon in a Canadian facility before growing them out in a Panamanian fish farm.

“It’s very straight-forward,” said Ron Stotish, AquaBounty president and CEO, in an earlier interview with Farm Press. “These fish are basically genetically identical to all other Atlantic salmon with one exception: we’ve added a single gene for the growth hormone from a Chinook salmon. A single copy of that gene has been placed in the Atlantic salmon background so that fish grows faster than the unmodified Atlantic salmon.”

(For more, see Genetically-engineered salmon caught in tangled regulatory net)

Stotish said that equates to “roughly one gene out of, probably, 30,000 … a very minor, very specific change. And what we’ve done is basically give the fish the ability to grow faster when conditions – water temperature and food -- permit. That distinguishes it from its wild counterpart.”

The GE salmon’s actual rate of growth means it is able to reach“market-weight in approximately half the time.”

In January of 2012, the Subcommittee on Oceans, Atmosphere, Fisheries, and Coast Guard held a hearing on the GE salmon (read story here). Questions mostly came from the chairman, Alaska Sen. Mark Begich, and Maine Sen. Olympia Snowe (since retired). Both have large salmon industries in their states and Begich had introduced S.1717, which would ban interstate commerce of genetically engineered salmon.

There was little movement from the FDA on the issues until the Dec. 20 environmental assessment. Shortly after its release, Stotish again spoke with Farm Press. Among his comments:

On the FDA ruling going forward…

“This isn’t a final decision. All they did was publish a draft environmental assessment for public comment. The comment period will be 60 days. Normally, the period is for 30 days but they’re allowing 60 even though there’s been a two-year interval since the public meetings since 2010.

“I guess they’re using an abundance of caution and political correctness with this application.

“So, all they’re doing is publishing their assessment for comment. At the end of the 60 days, they’ll consider the comments and then decide what the next step is. That may include requiring additional changes if they receive any comments they believe are material.”

On the FDA ruling’s language…

“We’re quite pleased they’ve released the environmental assessment. It’s been a long time coming. We’re encouraged that, perhaps, we’re back on a science-based process and are hopeful that process will continue once the comments are in.”

Still no plans to move outside Panama and Canada?

“This initial assessment is based on the (Canadian) site for production of the eggs and the one grow-out facility in Panama. The way the FDA has reviewed this is with Panama being the first approved site for growing the fish.

“Additional sites will have to be submitted to the FDA. There will have to be an environmental assessment for those additional sites. The FDA will do approval and inspections of the sites prior to approval. So, any additional site will be subject to the same criteria as Panama has been in this application.

“Every site that grows this fish will be approved and inspected in advance by the FDA.”

Any rumblings about further hearings on this in Congress?

“There’s a lot of noise out there.

“There are people who believe that social, economic and other personal concerns have a place in this process. We don’t believe that’s appropriate.

“Anything is possible. We suspect there will be people who try to block this for all the wrong reasons. But we’ll continue to support the science-based process.

“We believe this application represents an opportunity to reduce imports, to create jobs in the United States, and to put a healthy and desirable food close to the American consumer. This is a good technology – it’s good for the United States and we hope to receive ultimate approval on the merits of the application.”

On Begich’s efforts to keep the GE salmon from production…

“The Alaskans are simply trying to protect their markets. … Well, that’s wrong, that’s bad regulatory policy, that’s bad for the American consumer and society.

“We hope reason prevails in this. But there are a lot of people who have a lot of vested interests and are opposing this for all the wrong reasons.”