The U.S. Food and Drug Administration (FDA) has released two documents for public comment concerning the agency’s regulation of certain forms of biotechnology. First, FDA released a draft revised guidance document on the regulation of animals produced using biotechnology, expanded in scope to include animals produced through the use of genome editing. In the notice of availability for the guidance, FDA also is soliciting comments on the terminology it should use to be inclusive of the use of genome editing techniques as well as the level of risk associated with animals that have been altered using genome editing. Second, FDA issued a request for comment related to the regulation of food from plants produced using genome editing techniques. These documents signal that FDA is contemplating revising its current regulatory structure to address the use of genome editing technology in plants and animals. Comments for both items are due April 19, 2017.
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