Process for approving genetically engineered animals flawed, says AU professor
by PAUL HOLLIS
Federal regulators have approved a fast-growing transgenic salmon as the first genetically engineered animal available for human consumption. And while some are hailing it as a historic breakthrough, others are questioning whether the current approval process for the technology is stringent enough to prevent risks to the environment.
One of those doing the questioning is Auburn University’s Conner Bailey.
Bailey recently published a policy review, “Transgenic Salmon: Science, Politics, and Flawed Policy,” in the international journal Society & Natural Resources, in which he calls for reconsideration of the policy that designated the Food and Drug Administration as the approving agency for genetically engineered animals.
The FDA has the lead regulatory role because of a federal decision made in 1986 and updated in 1992 that established the Coordinated Framework for the Regulation of Biotechnology, Bailey said. This framework was designed to establish clear responsibilities over genetically engineered products among the U.S. Department of Agriculture, the U.S. Environmental Protection Agency and the FDA.
While Bailey’s article was working its way through the review process, the Obama Administration ordered a reconsideration of how transgenic animals and plans are reviewed and subsequently approved, giving the three agencies one year to accomplish the task. This reconsideration, however, will not affect the FDA’s Nov. 19 decision to approve production and consumption of a transgenic salmon.
Bailey, a professor in the College of Agriculture’s Department of Agricultural Economics and Rural Sociology, contends the FDA should not being making such a determination on its own.
“The FDA is ill-equipped, on its own, to make a science-based decision on ecological impacts,” Bailey said. “While the agency has staff expertise on questions of food safety, they have zero staff expertise on issues associated with aquatic ecology and aquaculture. The risk of releasing what is essentially an exotic species into the wild is real and potentially significant.”
The agency’s recent action is precedent setting, said Bailey, and likely will lead to the adoption of genetic engineering in other fish species and possibly other animals as well.
AquaBounty Technologies, a private corporation, began developing a transgenic salmon in 1989 by inserting genes from two different species of fish into the Atlantic salmon to promote more rapid growth. The company also has developed transgenic tilapia, trout and shrimp. In addition, genetic engineering research is underway on 35 fish species in different countries, including China, Cuba, India, the Philippines and Thailand, as well as the United States. Thus, the FDA’s approval of the transgenic salmon could have far-reaching consequences.
“Fish are ideally suited to genetic engineering, due to the large number of eggs produced by a single female, allowing for faster genetic testing and development compared to land-based animals,” Bailey said.
The FDA permit authorizes production of transgenic salmon eggs in Canada and production of the fish itself in the highlands of Panama, and there are few ecological risks associated with this production system, Bailey said. The problem, he said, is that the FDA only looked at physical barriers associated with these two sites and did not conduct a more comprehensive risk analysis that would have prepared FDA for the all-but-inevitable expansion of production into new areas, possibly using open water cages such as those used in conventional salmon farming. Escapes from such farms have established breeding populations of Atlantic salmon in the Pacific Northwest. The consequences of a release of a transgenic fish into the aquatic environment are unknown but potentially serious.
Bailey said a careful, comprehensive approach is needed to address transgenic fish—a process involving those federal agencies that have the requisite expertise to make a full evaluation of food safety, social impacts, and environmental risks.
“In the case of transgenic marine fish species, the National Marine Fisheries Service would be the appropriate agency, while for freshwater transgenic fish, USDA could take the lead,” Bailey said. “In both cases, the U.S. Fish and Wildlife Service should be involved to ensure that a strong conservation voice is represented.”
A full environmental impact statement, including a full social impact assessment, should be the standard approach when considering the introduction of transgenic animals, and, in particular, transgenic fish that may pose unique environmental risks, Bailey said.
“But the more pressing need is to overhaul the existing approval framework to address the unique challenges posed by introducing transgenic fish,” he said.
Read the full content of Bailey’s article here.
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