ASA Asks FDA to Extend Comment Periods on Gene Editing Proposals

The American Soybean Association (ASA) and several others in the agriculture industry are asking the Food and Drug Administration (FDA) for an extension of the comment periods for two proposed regulations:

  • Genome Editing in New Plant Varieties Used for Foods: FDA-2016-N-4389
  • Regulation of Intentionally Altered Genomic DNA in Animals: FDA-2008-D-0394

The regulations were proposed on Jan. 19, just as the Obama administration was leaving office. 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 The second is a draft guidance on “Regulation of Intentional Altered Genomic DNA in Animals,” which extends the scope of FDA’s regulatory authority to include gene-edited animals.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 have comment periods that end on April 19.

The proposals were issued at the same time as the U.S. Department of Agriculture’s (USDA) proposed rule on Part 340 of the Plant Protection Act, which would update how GMO plants are regulated.

Because the issues are interrelated, ASA and others asked that the comment periods be extended to match the June 19 comment deadline for Part 340, giving stakeholders more time to review all of the documents and take a more coordinated approach to comments.