FDA releases draft guidance on regulating GE animals and their products
Genetically engineered animals and their products, most notably food products, are closer to reaching the market now that the Food and Drug Administration has released draft guidance on their regulation.
The FDA intends for the guidance document, which the agency released Sept. 18 for comment, to clarify its regulatory authority and the requirements and recommendations for developers of GE animals and products from GE animals.
“This is a cutting-edge technology that has significant implications, including real benefits, not just for human health, but also for animal health, such as developing disease-resistant animals,” said Dr. Bernadette M. Dunham, director of the FDA Center for Veterinary Medicine.
The AVMA responded to the FDA guidance with a statement that noted potential benefits of GE animals while urging stakeholders to keep animal welfare in mind.
“The development and appropriate regulation of this technology has widespread applications in advancing our knowledge of diseases, food safety, environmental conservation, and efficient food and fiber production,” wrote Dr. W. Ron DeHaven, AVMA chief executive officer, in the AVMA response
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