FDA Backs Safety of Transgenic Fish

A fast-growing salmon moves closer to approval after a fishy delay















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Transgenic AquAdvantage salmon grow twice as fast as wild Atlantic salmon. Image: Barrett & McKay Photography / AquaBounty

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The first genetically engineered (GE) animal for human consumption—a fast-growing salmon—has come a step closer to the dinner table, with a piece of paperwork posted online on December 22 by the US Food and Drug Administration (FDA).

The FDA’s draft environmental assessment concludes that the fish poses no foreseeable risk to nature. After 60 days of public comment, the FDA may issue a final assessment and approval—at which time AquaBounty, of Maynard, Mass., can begin selling the fish.

However, the draft assessment was dated 4 May, suggesting that the FDA had kept its conclusions under wraps for several months. Advocates on both sides of the issue speculate that political interference may be responsible. “I think it was controversial, and it was an election year,” says Patty Lovera, assistant director of Food and Water Watch, a Washington, D.C., group opposed to GE food animals. An FDA spokeswoman, Morgan Liscinsky, declined to comment on accusations that the process had been politicized, and says it’s possible that the agency could request further studies after the public comment period.

Delays would not shock AquaBounty's CEO, Ron Stotish, whose company has been seeking FDA approval for the fish since 1995. When he was alerted to the decision today, he didn’t initially believe it. “I said, ‘I’ll wait until I see it because I’ve received calls like this before and it never happened,’” he says. The FDA has reviewed more than 50 safety studies, including one that shows the engineered salmon poses no more of an allergic potential than a wild salmon. The engineered Atlantic salmon contains an active growth-hormone gene from a Chinook salmon that allows it to reach market weight in 18 months rather than three years.

Anti-GE groups still have a long list of concerns. Lovera would like to see more studies done on the potential health risks of the salmon, published in peer-reviewed journals and conducted by scientists with no affiliation to AquaBounty. However, it’s not clear where the money to conduct such tests would come from, as federal research funding rarely supports GE animals.

The GE salmon are currently kept within enclosed, inland tanks to prevent the small risk that the nearly sterile females will breed with wild salmon. But Lovera still worries that once the fish are approved, manufacturers will file for permits to keep them within nets in the open ocean in order to lower costs. “This is basically the final step and we think the FDA has given a strong signal that they will accept the fish, and that is a mistake,” she says.

Stotish counters that as part of their application, AquaBounty has promised to not sell the fish to farmers who do not have enclosed, inland tanks. After 17 years and $60 million spent trying to win FDA approval, Stotish is still cautious. ”We are not so foolish to think that this process will suddenly be normal for us,” he says.

This article is reproduced with permission from the magazine Nature. The article was first published on December 22, 2012.



9 Comments

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  1. 1. alan6302 07:37 AM 12/23/12

    Animals have been genetically engineered forever. We are. That is why humans have so many genetic errors.

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  2. 2. brainguy 10:44 AM 12/23/12

    This is beyond crazy! With ALL overwhelming evidence of the dangerous of transgenic foods.

    If you are concerned with, not only your own health, but the health of your future kids, grandkids and so on FIGHT this.

    These frankenfood is very dangerous. A quick study on Monsanto's corn and soy can yield some pretty scary results.

    Be aware... Or suffer!

    Reply | Report Abuse | Link to this
  3. 3. alan6302 11:18 AM 12/23/12

    Here is an easy test.
    Put GMO salmon wild salmon and farmed salmon in rat cages . If rats get sick ,they will eventually stop eating one of them. Rats refuse GMO corn after a while.

    Reply | Report Abuse | Link to this
  4. 4. randoo 02:28 PM 12/23/12


    For all the hue and cry about how we are decimating the planet's biota, we only accelerate the destruction. We need to continue to develop the promise of genetic engineering. We've overrun the planet. Earth will continue to become more fully our own creation. I hope we have the best creative tools we can to deal with that challenge.

    Reply | Report Abuse | Link to this
  5. 5. Dolmance 02:32 PM 12/23/12

    Somehow, I don't have a lot of faith in a country where any industry can buy influence and shut down scientific studies which happen to not jibe with what some hateful old plutocrat believes.

    Reply | Report Abuse | Link to this
  6. 6. genevehicle 02:57 PM 12/23/12

    These "salmon" won't remain restricted to inland pens, despite any "promises" by AquaBounty.
    That salmon farming, as currently practiced in the close-in-shore open net application, causes serious damage to local ecosystems and posses a serious risk to transient wild stocks is beyond question.
    If providing/eating healthy seafood is our goal, our efforts would better spent continuing the proper management of existing wild stocks and rebuilding those runs that are in danger.
    Boycott farmed salmon and demand GMO labeling.
    Write or email your Congressman(woman) today.

    Reply | Report Abuse | Link to this
  7. 7. Dolmance in reply to Forsythkid 05:45 PM 12/23/12

    With a double shot of Paraquat and a Fen-Fen chaser.

    Reply | Report Abuse | Link to this
  8. 8. kienhua68 05:25 PM 12/31/12

    There will always be those who dwell in conjured threat.
    Fish are just a tiny fraction of our efforts to increase
    food productivity. If we want to have certain foods for the future, there is not much choice. Seven billion mouths to feed.

    Reply | Report Abuse | Link to this
  9. 9. escapefromobamastan 10:57 PM 12/31/12

    The thing is NOBODY believes anything the FDA says anymore AND nobody wants to eat (or feed their children) genetically modified food or animals. There is conveniently no labeling law, so it can be stuffed down consumers throats without their knowledge. All for corporate profits. The FDA has been bought of by Monsanto, etc. and there is a revolving door of CEOs of corporations like Monsanto moving into positions in the FDA which makes it easy for them to get their poison approved, such as Aspartame. Even a supreme court judge was once an attorney for Monsanto.

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