The Food and Drug Administration and U.S. Department of Agriculture last week issued a variety of policy documents on the regulation of products of biotechnology, specifically products produced using new techniques such as gene editing. These guidance documents were issued as part of the National Strategy for Modernizing the Regulatory System for Biotechnology Products, issued by the Obama Administration in the fall of 2016 and the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology, issued by the Obama Administration earlier this month.
This guidance is important to IDFA members that use products or ingredients made through biotechnology, such as sugar from genetically engineered corn or beets or fermentation-produced chymosin. These actions ensure that these and future biotechnology products are properly regulated and safe for consumers and the environment.
At this point in time, it is unclear how the Trump Administration’s regulatory freeze memorandum affects these proposed regulatory guidance documents.
FDA Policy and Request for Comment
FDA released three guidance documents that describe its approach to regulating certain new biotechnology products, including:
The animal guidance provides information on the steps a company would need to take to receive authorization for an animal with intentionally altered genomic DNA to enter the food supply.
FDA’s request for comment on gene-edited plant varieties seeks to help inform the agency’s regulatory approach to human and animal foods derived from those plant varieties. FDA is accepting comments until April 19.
USDA’s Proposed Rule
USDA’s Animal and Plant Health Inspection Service (APHIS) issued a proposed rule, “Plant Pest Regulations; Update of Provisions,” which updates its regulation of genetically engineered organisms that may pose plant pest or noxious weed risks. The changes are meant to take into account advances in genetic engineering.
These revisions would change how APHIS determines which products are under its regulatory authority by creating a new trigger for regulation and by revising definitions that may broaden the array of biotechnology products APHIS regulates. Products that meet the criteria for regulation and are not exempt would undergo a regulatory review to determine if any regulatory restrictions should be placed on the product.
For more information, read “Questions & Answers: APHIS Requests Public Input on Next Steps towards Revision of Its Biotechnology Regulations.”
APHIS is accepting comments on the proposed rule through May 19.
Members with questions may contact Emily Lyons, IDFA director of regulatory affairs and counsel, at email@example.com.