Gene editing has the potential to improve animal health, reduce antibiotic use, and help produce safe food if it is not overregulated, the National Pork Producers Council (NPPC) said in Capital Update on Aug. 23.
“Treating gene edits as an “animal drug” could force the technology to other countries, which already are taking a science-based approach on the issue,” the organization noted.
Although NPPC supports the FDA’s efforts to clarify regulatory requirements for developers of intentional genomic alterations in animals, as well as efforts clarifying that downstream producers choosing to invest in this technology will be exempt from regulatory oversight, it does not believe the updated guidance offers any significant improvement to the burdensome regulatory process.
The updated guidance, GFI #187B Heritable Intentional Genomic Alterations in Animals: The Approval Process, treats “altered genomic DNA” as a drug under the Food, Drug & Cosmetic (FD&C) Act because it is “an article intended to affect the structure or function of the body of the animal, and, in some cases, intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in the animal.”
In comments to the FDA on July 31, NPPC notes that the updated guidance did not take into account gene editing that deletes DNA or inserts DNA that could be found naturally. In updating the guidance, FDA said an alteration that has an effect on animal disease, such as creating resistance to a disease, would be subject to regulation under the FD&C Act — a burdensome, costly, and time-consuming process.
NPPC previously asked FDA to use a National Academies of Sciences report to determine what, if any, approval under the FD&C Act is required for gene edited animals that are not intended for producing biopharmaceuticals or medical devices.
“Gene editing offers a tremendous opportunity for the U.S. pork industry, but continued regulation under FDA and the FD&C Act create extreme barriers to utilization by industry and is not in keeping with federal policy and precedence — and indeed global regulatory trends — concerning the use of biotechnology in agriculture,” NPPC concluded in its comments.
NPPC will continue to advocate for the transfer regulatory authority over gene editing from FDA to the USDA.
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