UPDATED April 12, 2017: The FDA is extending the comment period to continue seeking public input on draft revised Guidance for Industry #187, Regulation of Intentionally Altered Genomic DNA in Animals. The FDA is taking this action in response to requests for additional time to submit comments. The comment period will now close on June 19, 2017.
Also in response to requests for additional time to submit comments, the FDA is extending the comment period to continue seeking public input to inform its regulatory approach to human and animal foods derived from plants developed using genome editing. The comment period will now close on June 19, 2017.
January 18, 2017
The U.S. Food and Drug Administration released today three documents for public comment about steps the agency is taking to clarify its regulation of certain biotechnology and mosquito-related products.
The FDA is requesting public comment on a draft revised guidance on the regulation of animals with intentionally altered genomic DNA, including animals produced through the use of genome editing and genetic engineering; a request for comment related to the regulation of foods from plants produced using genome editing technologies; and a draft guidance that clarifies which mosquito-related products FDA regulates and which such products EPA regulates, regardless of whether these mosquito-related products are developed using biotechnology.
These announcements are consistent with the FDA’s commitments outlined in the National Strategy for Modernizing the Regulatory System for Biotechnology Products (the Strategy; 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.
Draft guidance for industry on intentionally altered genomic DNA in animals
In the Strategy, the FDA noted its intent to clarify how developers of animals produced using emerging technologies, including genome editing, may meet applicable statutory and regulatory requirements. Consistent with this commitment, FDA is issuing draft revised Guidance for Industry #187, Regulation of Intentionally Altered Genomic DNA in Animals, for public comment.
The draft revised guidance clarifies that the FDA generally regulates animals with intentionally altered genomic DNA, including genetically engineered animals, under the new animal drug provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act, because, unless otherwise excluded, altered genomic DNA in an animal that is intended to affect the structure or function of the body of that animal meets the definition of a drug. The requirements and recommendations for developers of these animals are outlined in the draft revision.
The FDA encourages public comments on draft revised guidance #187 during the 90-day comment period, as well as on several questions the agency posed in the notice of availability announcing the guidance in the Federal Register. These questions concern appropriate terminology, and whether scientific evidence demonstrates that there are categories of intentional alterations of genomic DNA in animals that pose low to no significant risk. Public comments will be accepted starting on January 19, 2017.
Request for comment on the use of genome editing in plants intended for food
As part of the agency’s implementation of the Strategy, the FDA is seeking public input to help inform its regulatory approach to human and animal foods derived from plants developed using genome editing. The agency is seeking scientific evidence and other factual information on specific questions during a 90-day comment period. Comments received will help inform the FDA’s thinking on human and animal foods derived from new plant varieties produced using genome editing.
Any company looking to market foods is responsible for complying with all applicable laws and regulations. Foods from new plant varieties must meet the same food safety requirements under the FD&C Act, regardless of how the new varieties are produced. For more than 20 years, developers have routinely consulted FDA about the safety and regulatory status of foods from new genetically engineered plant varieties prior to marketing. The FDA intends to continue offering consultations for developers of new plant varieties, including those produced using genome editing, in order to help developers ensure that applicable safety and legal questions are resolved prior to marketing.
The agency is accepting public comment on this issue for 90 days starting on January 19, 2017.
Draft guidance for industry on mosquito-related products
As part of the Strategy, the FDA and EPA committed to considering mechanisms that would enable EPA to regulate certain mosquito-related products under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) when the developer claims they are intended to control mosquito population levels, and the FDA to regulate them under the FD&C Act when the developer makes other claims, such as a disease prevention claim.
The FDA’s draft Guidance for Industry #236, developed in coordination with EPA, describes the FDA’s understanding that mosquito-related products intended to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes for population control purposes are not “drugs” under the FD&C Act, and, when the guidance is finalized, will be regulated by EPA under FIFRA. Under the draft guidance, FDA would continue to have jurisdiction over mosquito-related products that meet the FD&C Act drug definition, such as those intended to prevent, treat, or cure a disease.
The FDA encourages public comments on draft guidance #236 for 30 days starting on January 19, 2017.
These activities, together with the recent release of the final 2017 Update to the Coordinated Framework for the Regulation of Biotechnology, are part of an ongoing effort to modernize the regulatory system for biotechnology products.
The FDA is accepting public comments on these documents beginning on January 19, 2017. To electronically submit comments to the docket, visit www.regulations.gov and use the docket numbers listed below.
To submit comments to the docket by mail, use the following address. Be sure to include the appropriate docket number on each page of your written comments.
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Comments will be accepted at any time, but should be submitted no later than the closing date to ensure that the FDA takes the information into consideration before making further decisions on this issue.
- Draft revised GFI #187: Regulation of Intentionally Altered Genomic DNA in Animals, Docket Number FDA-2008-D-039, closes on April 19, 2017
- Request for Comments: Genome Editing in New Plant Varieties Used For Foods, Docket Number FDA-2016-N-4389, closes on April 19, 2017
- Draft GFI #236: Regulation of Mosquito-Related Products, Docket Number FDA-2016-D-4482, closes on February 21, 2017
- FDA Voice: FDA’s Science-based Approach to Genome Edited Products
- GFI #187: Regulation of Intentionally Altered Genomic DNA in Genetically Engineered Animals; Draft Guidance for Industry
- Genome Editing in New Plant Varieties Used for Foods; Request for Comments
- GFI #236: Regulation of Mosquito-Related Products; Draft Guidance for Industry
- Modernizing the Regulatory System for Biotechnology Products
- Animals with Intentionally Altered Genomes – Q&A
- Foods derived from plants produced using genome editing
- Food from Genetically Engineered Plants – Q&A