Animal & Veterinary

Intentionally Altered Genomic DNA in Animals and Plants

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 19, 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 the comment period, which closes on June 19, 2017. Comments received will help inform the FDA’s thinking on human and animal foods derived from new plant varieties produced using genome editing.

Page Last Updated: 05/02/2017
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