Intentionally altering genomic DNA is a process that includes, but is not necessarily limited to, the use of genome editing technologies or genetic engineering to introduce desirable traits into organisms.
On January 18, 2017, the FDA released draft revised Guidance for Industry (GFI) #187, “Regulation of Intentionally Altered Genomic DNA in Animals,” and requested public comment regarding the regulation of animals with intentionally altered genomic DNA.
The FDA is also 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.
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.
Modernizing the Regulatory System for Biotechnology Products FDA Requests Comments on Documents Related to Certain Biotechnology and Mosquito-related Products Animals with Intentionally Altered Genomic DNA Q&A on FDA Regulation of Intentionally Altered Genomic DNA in Animals
- Genetically Engineered Plants for Food & Feed
Foods Derived From Plants Produced Using Genome Editing Labeling of Foods Derived From Genetically Engineered Plants