The Food and Drug Administration for the first time cleared the marketing of products from a biotech food animal, approving beef cattle that are genetically altered to be more tolerant of hot weather.
FDA announced Monday that it found no safety concerns with the distribution of products from the two gene-edited cattle and their offspring. The cattle have a short-hair, “slick” coat.
The agency has come under criticism from the livestock industry for the lack of approvals of biotech animal traits. The Trump administration attempted in its final days to transfer some of FDA’s authority to the Agriculture Department.
This case was the first in which the agency had made a “low-risk determination” for a gene-altered food animal.
Steven Solomon, director of FDA’s Center for Veterinary Medicine, said he hoped the decision would encourage other developers of other biotech traits to submit them to the agency for approval.
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The “decision underscores our commitment to using a risk and science-based, data-driven process that focuses on safety to the animals containing intentional genomic alterations and safety to the people who eat the food produced by these animals,” said Solomon.
Because of the low-risk determination, the agency said it will not expect the developer of the beef cattle trait to ask for approval to market food from the animals.
Approval of the trait was requested by Acceligen Inc., a subsidiary of Recombinetics Inc., a biotech firm.
FDA’s risk assessment of the trait said it was "the equivalent to the naturally occurring slick mutations that occur in several breeds of conventionally raised cattle where they likely developed as an adaptation to being raised in tropical or subtropical environments.”
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