Perdue signs memo to take over genetic engineering, but FDA head objects
Agriculture Secretary Sonny Perdue and Assistant Secretary for Health and Public Health Service Admiral Brett Giroir signed a memorandum of understanding transferring some of the responsibilities for agricultural animal biotechnology regulation from the Food and Drug Administration to USDA, but FDA Commissioner Stephen Hahn said the agency does not support it, making it unlikely the agreement will be honored in the Biden administration.
FDA is a division of the Health and Human Services Department.
“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 after signing the agreement. “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.”
But Hahn tweeted, “FDA does not support the Memorandum of Understanding that @HHSGov signed with @USDA announced today. FDA has no intention of abdicating our public health mandate. We’ll continue to stay focused on executing our vital public health mission entrusted to us by the American people.”
This agreement says it “will become effective when signed by both parties and made publicly available on the USDA and FDA websites. This agreement may be modified by mutual written consent by the parties at any time and may be terminated by mutual written consent by the parties no sooner than three years following the latest date upon which this MOU is signed or anytime thereafter. The agencies agree that they will review this agreement every three years to determine whether it should be modified.”
The National Pork Producers Council and the American Soybean Association praised the agreement.
NPP said it “applauds the memorandum of understanding (MOU) signed today between the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA), giving USDA primary regulatory jurisdiction over the development of gene-edited livestock. 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 (ASA) said it applauded an agreement “that would establish USDA as the lead regulatory agency for genetically engineered animals intended for agricultural purposes, transitioning parts of FDA’s existing role over to USDA.”
ASA President Kevin Scott, a soy grower from Valley Springs, S.D., said, “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. We have great confidence in USDA’s ability to develop an appropriate regulatory pathway for these important tools.”
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