The U.S. Food and Drug Administration (FDA) is extending the comment period to continue seeking public input on the draft revised guidance regarding its regulatory approach to human and animal foods derived from plants developed using genome editing. The agency is also extending the comment period for the draft guidance on regulation of intentionally altered genomic DNA in animals. The FDA is taking these actions in response to requests for additional time to submit comments. The comment periods will now close on June 19, 2017.
Originally released in January, the documents concern steps the agency is taking to clarify its regulation of certain biotechnology products. These announcements are consistent with the FDA’s commitments outlined in the “National Strategy for Modernizing the Regulatory System for Biotechnology Products” released in September 2016, which sets forth a vision for ensuring that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology.