FDA Issues Draft Guidance for Industry: Regulation of Intentionally Altered Genomic DNA in Animals

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.

This draft revised guidance applies to the intentionally altered genomic DNA in both the founder animal in which the initial alteration event occurred and the entire subsequent lineage of animals that contains the genomic alteration.

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. Specifically, FDA is evaluating their regulatory program to determine if they should revise regulations regarding the importation, interstate movement, and environmental release of genetically engineered organisms.

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.

Intentionally altering genomic DNA is defined as 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.”

“FDA is issuing this draft revised Guidance for Industry to clarify its approach to the regulation of intentionally altered genomic DNA in animals. This guidance addresses animals whose genomes have been intentionally altered using modern molecular technologies, which may include random or targeted DNA sequence changes including nucleotide insertions, substitutions, or deletions, or other technologies that introduce specific changes to the genome of the animal. This guidance applies to the intentionally altered genomic DNA in both the founder animal in which the initial alteration event occurred and the entire subsequent lineage of animals that contains the genomic alteration.”

FDA has also determined that it would be appropriate to announce concurrently the availability of draft guidance GFI 236, which clarifies ‎that products intended for preventing, destroying, repelling or mitigating mosquitoes for population control are excluded from the new animal drug definition, including those mosquito-related products with intentionally altered genomic DNA.

The new Biotechnology Working Group under the Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has implemented the following tasks:

EPA, FDA, AND USDA HAVE COMMISSIONED AN INDEPENDENT STUDY BY THE NATIONAL ACADEMY OF SCIENCES (NAS), AN EXPERT ANALYSIS OF THE FUTURE LANDSCAPE OF BIOTECHNOLOGY PRODUCTS, TO SUPPORT THE NATIONAL STRATEGY FOR MODERNIZING THE REGULATORY FRAMEWORK FOR BIOTECHNOLOGY PRODUCTS. REPRESENTATIVES OF MORE THAN 12 SCIENTIFIC SOCIETIES WILL MEET TO EXPLORE THE FINDINGS, CONCLUSIONS, AND RECOMMENDATIONS OF THE REPORT.

ABOUT THE EXPERT ANALYSIS

The committee has provided an independent and objective examination of the future products of biotechnology that includes:

  • Describing the major advances and the potential new types of biotechnology products likely to emerge over the next five to ten years;
  • Describing the existing risk analysis system for biotechnology products, including but not limited to risk analyses developed and used by the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA), and describing each agency’s authorities as they pertain to the products of biotechnology;
  • Determining whether potential future products could pose different types of risks relative to existing products and organisms (where appropriate, identifying areas in which the risks or lack of risks relating to the products of biotechnology are well understood); and
  • Indicating what scientific capabilities, tools, and expertise may be useful to the regulatory agencies to support oversight of potential future products of biotechnology.

 

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