On December 21st, Dr. Sonny Perdue, Secretary of the USDA released an Advance Notice of Proposed Rule Making to place jurisdiction of GMO animals under the USDA.
The proposed Rule conforms to a 2019 Presidential Executive Order directing Federal agencies to modernize regulatory frameworks to advance agricultural biotechnology.
The proposed Rule would transition regulatory oversight from the FDA to USDA to establish a “flexible, forward-looking, risk-proportionate and science-based regulatory framework that provides a predictable pathway to commercialization.”
The safety review would cover molecular characterization, animal health, efficacy, environmental considerations, food safety evaluation and processing. If adopted the Rule would require regulations to be framed under authority of the Animal Health Protection Act, Federal Meat Inspection Act and the Poultry Products Inspection Act.