WASHINGTON — The National Pork Producers Council (NPPC) is advocating for the transfer of regulatory authority regarding gene editing from the US Food and Drug Administration (FDA) to the US Department of Agriculture (USDA). The group is concerned that treating gene editing like an “animal drug” could deter the technology to other countries, where a science-based approach is already implemented.

On July 31, NPPC wrote a letter to the FDA on the agency’s updated guidance for gene editing in food animals. The group said the updates do not offer “any significant improvement to the burdensome regulatory process historically imposed on developers” of gene edited animals.

NPPC believes gene editing has the potential to improve animal health, reduce antibiotic use and help produce safe food if it is not overregulated.

The group supports FDA’s efforts to clarify regulatory requirements for developers of intentional genomic alterations in animals and to clarify downstream producers choosing to invest in this technology will be exempt from regulatory oversight. NPPC had previously asked FDA to use a National Academies of Sciences report to determine what, if any, approval under the Food, Drug & Cosmetic (FD&C) Act is required for gene edited animals that are not intended for producing biopharmaceuticals or medical devices.

However, the FDA’s clarification on oversight of gene edited animals has the pork group in dissent.

FDA’s guidance treats altered genomic DNA as a drug under the 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 NPPC’s argument, the group notes that the deletion or insertion of DNA can be found naturally in an animal, which it says FDA does not take into account.

The updated guidance clarifies that 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.

“Gene editing offers a tremendous opportunity for the US 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 said.