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Genetically engineered salmon produced by Massachusetts-based AquaBounty Technologies are not a significant risk to the environment, according to a draft assessment released by FDA last month. The company has been waiting for FDA approval of the engineered salmon, which grow faster than nonengineered salmon, for more than a decade. Genetically engineered animals are considered new animal drugs and therefore need FDA’s approval before they can be marketed. As the first step in this process, FDA previously declared the engineered salmon safe for human consumption. The environmental assessment—an additional requirement under new animal drug provisions of the Federal Food, Drug & Cosmetic Act—could be the last step before FDA approval. So far, the process has been plagued by politics, and some members of Congress are likely to keep trying to stop the approval, the company says. The primary concern is that the engineered salmon could escape from farms and outcompete wild salmon species. If FDA approves the salmon, it will be the first time a genetically engineered animal has been approved for food consumption in the U.S.
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