Outgoing Agriculture Secretary Sonny Perdue on Tuesday announced he had signed a memorandum of understanding with an assistant secretary for Health and Human Services that "clears a path" for USDA to take over as the primary regulatory jurisdiction for gene-edited livestock.
The timing of the four-page memorandum of understanding (MOU) will leave the decision as closely watched with new leadership heading to both USDA and the Department of Health and Human Services. The MOU states the agreement can be modified at any time, and could be terminated after three years as well.
Perdue signed a four-page memorandum last week between USDA, Health and Human Services and the FDA spelling out responsibilities for using genetic engineering of animals for human food, fiber and labor. The move follows President Donald Trump's executive order in 2019 to streamline the regulations around animal biotechnology. "Today's Memorandum of Understanding clears a path to bring our regulatory framework into the 21st century, putting American producers on a level playing field with their competitors around the world. In the past, regulations stifled innovation, causing American businesses to play catch-up and cede market share," Perdue said. "America has the safest and most affordable food supply in the entire world thanks to the innovation of our farmers, ranchers and producers. Establishing a new, transparent, risk and science-based regulatory framework would ensure this continues to be the case."
The MOU also falls in line with USDA's "advance notice of proposed rulemaking" posted last month in the Federal Register seeking comments that would turn control of regulations for genetically-engineered animals to USDA's Animal and Plant Health Inspection Service.
Perdue signed the MOU on Jan. 13 with Admiral Brett Giroir, the assistant secretary for health, and head of the Public Health Service at the U.S. Department of Health and Human Services. The MOU was signed by Giroir instead of FDA Commissioner Stephen Hahn. The news outlet Politico had reported last week Hahn had refused to sign the proposal to transfer regulatory power from his agency to USDA.
The MOU gives USDA the authority to start drafting rules for regulating genetically engineered animals through the Animal Health Protection Act. As a "single point of entry" for genetically engineered animals, USDA will become the "one-stop shop" Perdue pitched in a news release back in December.
USDA also will set up rules for meat inspection and food-safety oversight as well. FDA will continue some oversight of certain products and consult with USDA, as well as maintain oversight for biopharma products.
The move to shift regulatory approval of genetically-engineered animals from FDA to USDA has been a focus of the National Pork Producers Council. NPPC has criticized FDA's regulatory process as too slow and cumbersome, arguing FDA is hindering innovation. NPPC on Tuesday applauded the MOU.
"NPPC has been calling for this decision for more than three years to ensure that U.S. agriculture maintains its competitive edge globally. We look forward to working with the Biden administration to implement a technology that has the potential to improve animal health, further reduce agriculture's environmental footprint and improve production efficiency."
The American Soybean Association also issued a news release backing the announcement and move to establish USDA as the lead agency for regulating genetically engineered animals.
"Genetic solutions have the capability of protecting the health of our herds and flocks, and ASA continues to support predictable, timely, science-based processes for making these innovations available to producers," said Kevin Scott, president of ASA and a soybean farmer from South Dakota. "We have great confidence in USDA's ability to develop an appropriate regulatory pathway for these important tools."
USDA-HHS memorandum of understanding: https://www.aphis.usda.gov/…
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