After requests from the American Soybean Association (ASA) and others in the agriculture industry, the Food and Drug Administration (FDA) has agreed to extend comment periods for two proposed regulations:
- Draft revised GFI #187: Regulation of Intentionally Altered Genomic DNA in Animals, FDA-2008-D-0394
- Request for Comments: Genome Editing in New Plant Varieties Used For Foods, FDA-2016-N-4389
The regulations were originally proposed on Jan. 19. The first is a request for information on Genome Editing in New Plant Varieties Used for Foods which seeks input on food safety risks associated with foods derived from gene-edited crops. The second is a draft guidance on Regulation of Intentional Altered Genomic DNA in Animals, which extends the scope of FDA’s regulatory authority to include gene-edited animals. Both proposals originally had comment periods ending April 19, but they have been extended to coincide the June 19 comment deadline for Part 340. This gives ASA and other stakeholders the time needed to thoroughly review all the documents and take a more coordinated approach to comments.