Intentional Genomic Alterations in Animals and Plant Biotechnology for Animal Food

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.

FDA requested public input to help inform its regulatory approach to human and animal foods derived from plants developed using genome editing. The agency was also seeking scientific evidence and other factual information on specific questions during the comment period, which closed on June 19, 2017.

Resources

• FDA Requests Comments on Documents Related to Certain Biotechnology and Mosquito-related Products
• Animals with Intentional Genomic Alterations
• Q&A on FDA Regulation of Intentional Genomic Alterations in Animals
• Food from New Plant Varieties
• Understanding New Plant Varieties
• Voluntary Labeling of Foods Derived from Genetically Engineered Plants
• Agricultural Biotechnology
• Center for Veterinary Medicine (CVM) Animal Biotechnology Products Resource Center

Voluntary Consultations

• Biotechnology Notification File No. 000164 CVM Note to the File
  FAD2KO, high oleic acid soybean