February 13, 2013

FDA Feeling the Heat on Genetically Engineered Salmon

Leo Horrigan, MHS

Leo Horrigan, MHS

CLF Correspondent

Center for a Livable Future

Jillian Fry, Congressional briefing

Opposition is building rapidly to a pending approval of the first genetically-engineered animal in the U.S. food supply—AquaBounty’s GE version of the Atlantic salmon. The opposition is so strong, in fact, that the U.S. Food and Drug Administration just extended its public comment period by another 60 days.

Up until yesterday, the public was invited to submit comments until February 25 on FDA’s draft environmental assessment of GE salmon, in which the agency issued a preliminary finding that the salmon would have no significant impact on the U.S. environment. As of this morning, the deadline was extended to April 26, 2013.

As part of the mounting pressure on FDA, on Monday three groups opposed to the current process being used to consider approval of GE salmon—including the Johns Hopkins Center for a Livable Future—held a standing room only Capitol Hill briefing on the issue for Congressional staffers.

The three groups pilloried the process being used by the FDA to consider the GE salmon proposal, critiquing the process from three angles—the legal, public health, and consumer perspectives.

Attorney Andrew Kimbrell, Executive Director of the Center for Food Safety, laid out the problems with the regulatory process followed thus far, beginning with FDA’s decision to treat GE salmon as if it were a new animal drug instead of something much more momentous and precedent-setting. That decision meant that the GE salmon would be evaluated using a regulatory process primarily focused on evaluating a drug’s impact on an animal and it’s efficacy, and not on food safety considerations relevant to GE animals.

Jillian Fry, director of CLF’s Public Health & Sustainable Aquaculture Project, spelled out the reasons that the Center opposes the process for considering GE salmon, which she blogged about last week. These include the inadequate evaluation of the danger of GE salmon escaping into the wild and disrupting populations of wild salmon, especially as the industry adds more facilities; the lack of quality data from independent scientists rather than the company itself; and the lack of a labeling requirement for GE salmon, which means scientists would not be able to evaluate the societal impacts of the product.

Patty Lovera, assistant director of Food & Water Watch, stressed public opposition to the introduction of AquaBounty’s GE salmon (78 percent against in one poll), and public support for labeling such a product, if it does get approved. In a 2008 Consumer Reports poll, 95 percent of respondents said products derived from GE animals should be labeled as such.

The push for labeling got a boost last week when Rep. Don Young (R–AK) introduced a bill amending the Food, Drug and Cosmetic Act that would require labeling of genetically engineered fish.

As of yesterday, and despite all of the points being raised against GE salmon, AquaBounty’s product was in the home stretch in its persistent drive for approval. On Monday, at the briefing, Kimbrell said, “I think [FDA has] to at least act as if they’re paying attention to all of these comments coming in,” said Kimbrell, “but, you could see approval in the next 60 to 90 days [after Feb. 25], unless they feel the political pressure very strongly.”

Now it seems that FDA may be responding to the pressure.

To submit electronic comments to FDA about AquaBounty’s GE salmon, go to http://www.regulations.gov; or, submit written comments to the Division of Dockets Management (HFA–305); Food and Drug Administration; 5630 Fishers Lane, Room 1061; Rockville, MD 20852. (CLF’s comment to FDA is here.)

As of late Tuesday, the online global advocacy group Avaaz had generated nearly 1 million signatures on a petition asking FDA to not approve AquaBounty’s transgenic salmon.

17 Comments

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  14. Posted by Ekaterina Mikheeva

    Genetically engineered fish endangers wild populations of fish and the
    marine environment itself. Wild Salmon can not compete with any of GE salmon`s super-skills. It is not as temperature-resistant, or agressive; It has no cannibalism, unlike GE Salmon. Wild Salmon has no chances of survival in a competition with GE Salmon.
    Besides, GE Salmon might be the first GE animal for human consumption. And in a long-term period, nobody knows what causes and effects it might have.
    We shouldn`t forget that all of those chemicals and antibiotics that are injected into GE products for better resistance – all of that will be consumpted with the fish.
    It`s been years since GMO has been succesfully growing and had been popular among coorporations. And only recently, people started to notice, that the better look or better price of a product doesn`t worth it when it comes to health.

  15. Posted by Jonah McIntosh

    This seems like a seriously bad idea. I mean, look what happened to the introduction of the Cane Toad into the Australian ecosystem.

    And what about the damage that Monsanto’s genetically modified crop has wrought on the american farmer? Even a single stray seed carried by wind, animal, or even placed as sabotage by competing farmers can lead to a lawsuit. Previous lawsuits have bankrupted families that had no intention or even awareness that a few errant corn stalks might be Monsanto’s branded corn.

    What does it mean for american fishermen when they can be sued for hooking the wrong fish?

  16. Posted by Dan Terracin

    I have very mixed feelings when it comes to GMO’s in public food sources. First off, I 100% agree that any food that has been genetically altered through processes other that selective breeding should be labeled properly. This is just basic human consideration-we should be aware of what we are eating. I saw that the initial FDA report on the GE salmon produced in 2010 indicated that the fish showed no negative i pacts on human health. Just a few months ago, the same FDA team concluded that the salmon pose no foreseeable environmental impacts. I agree that the first statement may be true. Many GMO’s have been studied over the years and I know of no valid (published) scientific finding that states otherwise. However, I am not sure how dependable the latest report by the FDA can be. I did not read the report, however I believe I could speculate some potential problems. I initially thought of an idea revolving around the process of fish harvest. Aquaculture (fish farming) has long provided high quality protein sources around the world. However, these fish have been known to escape/mix with wild populations. This would be a huge concern with these Aquabounty salmon. Given that they grow larger and faster (although not that much larger) they could potentially exclude wild populations. For many fish species, the larger the individual, the more that fish can forage. This may be a possibility. Another is that these faster growing fish may quickly mate with wild populations. Many salmon populations and associated salon harvests are very reliant on the range of genetic diversity present within a population (run). If a bunch of super salmon invade an area- there is a potential that they may establish and potentially homogenize the population. This would decrease the populations ability to survive a wide range of environmental/physical changes that regularly mess with season runs and the amount available to fishers. Therefore, the management effort of pacific salmon should be to maximize genetic variation within the population so that runs can remain consistent. This idea is called the “portfolio effect”.

    Howver I read on the Aquabounty website that salmon farms are found on land rather than in sectioned off natural bodies of water (as many aquaculture systems usually are). Therefore the threat of mixing is reduced. However I had heard of how escape is still possible. A promise by the company to maintain only on land farm systems must be made. Many companies have moved to traditional within-aquatic systems- it is cheaper and allows for more harvest. There is too much incentive for a company like Aquabounty to follow in a similar manner.

    I think there is a need for more research regarding the effect of genetically altered salmon on the environment and how potential threats can be reduced by strict regulations in production and company procedures. I personally believe that a sustainable system of GMO aquaculture could help the public. Salmon are a safe, healthy form of protein that could help reduce North America’s preference for more unhealthy and less suitable sources of protein (i.e. cattle). Salmon runs have become more variable over the years due to impacts such as climate change, and this may be a solution. However,like I said, more research is required.

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