By Eric Hoffman

The environmental dangers posed by the FDA's approval of genetically engineered salmon for human consumption were highlighted in the fall issue of GeneWatch.1 Unfortunately, a whole herd of genetically engineered animals are in the works. If we do not fix our inadequate regulatory system now, we could face a host of irreversible risks in the future.

In the U.S., the process of regulating biotechnology comes from the "Coordinated Framework for Regulation of Biotechnology," which was created in 1986 to prevent biotechnology-specific regulations from being written. In their place, agencies were asked to use current rules and find ways to apply them to biotechnology products. The coordinated framework also designates which U.S. agencies will oversee which products. For example, the USDA approves genetically engineered (GE) crops before they can be planted, while the FDA governs GE crops once they leave the farm. The FDA also regulates GE animals for the production of food and pharmaceuticals. This has led to an absurd status quo, with FDA approving GE animals not as new foods, but as new animal drugs.

The FDA defines a "drug" as something that is intended to affect an animal's structure or function. For GE animals, recombinant DNA (the engineered genes) qualifies as a "drug" under the FDA's definition.  It is important to note that in the case of GE salmon, this "drug" does not improve the health of the salmon or the people consuming it. In fact, the rDNA construct that produces growth hormone year round is responsible for a number of adverse effects, such as jaw erosion and other physical abnormalities in the salmon, the potential for increased allergenicity among human consumers, and lower ratios of Omega-3 and -6 fatty acids in the meat-even though the presence of these healthy fats is one of the primary reasons many people choose to eat salmon in the first place.

The only reason GE salmon is being proposed as a "drug" is to allow the company that produces it to avoid the more stringent regulations that it may be subjected to if the GE salmon were defined as "food." Yet the salmon's recombinant DNA makes for a poor drug, as - it does not appear to provide any benefit to consumers or the environment. Like trying to fit a square peg into a round hole, the FDA is trying to force a genetically engineered food product into a regulation written for drugs.

Using the New Animal Drug (NAD) process to approve GE animals is also inappropriate, as it only compares the risk of GE salmon compared to eating non-GE salmon. The process fails to properly look at the major impact GE salmon will have on the environment or human health. It does not look at the impact GE salmon farming will have on fishing communities or the impact expanding use of GE salmon will have on the production and consumption of these fish. The NAD process does not require a proper cost-benefit analysis, nor does it look at alternatives to using GE fish entirely. At the heart of the issue, the NAD process fails to look at GE salmon approved for food as food and slyly tries to get these fish onto our plates without the proper precautions or environmental review. 

While this "frankenfish" is unsettling to most Americans (91% of whom don't want this fish to reach their plates), the trouble with GE animals does not end there. The same company that is marketing this GE salmon, AquaBounty Technologies, also has GE tilapia and GE trout waiting in the pipeline for approval. Another company, Hematech, is working on GE cows that theoretically cannot get mad cow disease, which begs the question: Is it really easier to alter the genome of a cow to stop producing prions in its brain than to simply stop feeding cows dead animal brains (which is how mad cow disease is spread)?

Other companies are looking into developing GE chickens that are unable to transmit bird flu, and recent reports from China revealed that researchers have created a GE cow that makes "human breast milk" instead of cow milk. And of course there is the "Enviropig" from a Canadian university, a transgenic pig that produces less phosphorus in its waste-allowing industrial animal factories to shove even more pigs into their tightly confined feedlots while continuing to pollute as much as they do today.

If the FDA approves the GE salmon for human consumption, it will open up a floodgate of GE animals onto our plates-and it is likely GE food products will not even be labeled as such. These approvals will all happen under the illogical regulatory framework of approving GE animals for food as "animal drugs" and not the foods they truly are.

So where are we now? The U.S. Food & Drug Administration's Veterinary Medicine Advisory Committee held a public hearing on the approval of GE salmon last September. Since then, the FDA has remained silent on the issue as it finalizes its Environmental Assessment, which will be posted for a 30-day comment period sometime soon (and will likely be completely inadequate).2  Approval will shortly follow this Environmental Assessment if the FDA does not find any significant environmental harms.

Since the FDA's hearings on the GE salmon, two federal bills were introduced in both the House and Senate by Senators Mark Begich (D-Alaska) and Lisa Murkowski (R-Alaska) as well as Representative Don Young (R-Alaska). These bills would ban the approval of GE salmon or require labeling if the fish is indeed approved. The current legislation proposed in Congress is important but the bills, if passed, are only a temporary fix for the larger problem of a completely inadequate system surrounding GE animal regulation.

What would the proper oversight of GE animals look like? Below is an outline of what regulations on GE animals that protect human health and the environment would entail.

Legislation on the approval, use, and commercialization of genetically engineered animals must:

  1. 1. Encompass all GE organisms for human or animal food, or food and feed containing GE organisms.
  2. 2. Require independent and comprehensive risk assessment of GE organisms, including:
    • Analysis of the engineered genes and their long term stability over multiple generations;
    • Safety of eating the GE animal or products from the GE animal;
    • Comprehensive and independent environmental impact reviews, including whether approval of any animal with a wild relative that lives in or could ever enter US jurisdiction;
    • Assess the economic harms likely to be caused by any approval; and
    • Assess the health and welfare of all GE animals over the lifespan of the animals.
  3. Require labeling of GE animals for:
    • All products intended for human or animal consumption that have been genetically engineered;
    • Any foods containing any amount of GE product; and
    • The creation of a tracking system of GE animals and products through the food supply.
  4. Mandate transparency in the approval process with adequate time and ability for public participation.3

Until such regulations are put in place, all decisions on the approval of GE animals for food must be stopped. Our current way of regulating GE animals as "new animal drugs" is nonsensical and does not require the proper analysis of risks to human health, the environment, the health of wild-type populations related to the GE animals, the economic impact these GE animals may have, or the level of transparency needed to guarantee a reasonable level of public participation in the decision-making process.

Contact your members of Congress today and ask them to co-sponsor HR 520 and HR 521 (in the House of Representatives) and S 229 and S 230 (in the Senate)  to stop the approval of GE salmon or require that these fish be labeled if approved.

Eric Hoffman is Biotechnology Policy Campaigner at Friends of the Earth U.S.



1. See "Fishy Business at the FDA," from Genewatch, Volume 23 Issue 4:

2. Twelve of the nation's largest environmental groups sent an open letter to the FDA asking for an independent and comprehensive Environmental Impact Statement to be completed in place of the less-thorough Environmental Assessment, as mandated by the National Environmental Policy Act:

3. This is an abridgment of DRAFT legislative principles for the regulation of genetically engineered animals developed by the Center for Food Safety

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The Council for Responsible Genetics’ Genetic Privacy Manual: Understanding the Threats- Understanding Your Rights will be a comprehensive, electronic source of information for the consumer on these issues.
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CRG has investigated and reported on the commercial claims made about genetically modified crops and transgenic animals introduced into the food supply.
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