In one of his final acts before leaving the USDA, Secretary of Agriculture Sonny Perdue signed an agreement ending a turf war between his department and the Department of Health and Human Services. It shifts oversight of gene-edited livestock to USDA.
A short time earlier, Food and Drug Administration Commissioner Stephen Hahn said he would not sign the memorandum of understanding (MOU) between the USDA and the FDA. But, Assistant Secretary for Health and Public Health Services Admiral Brett Giroir, M.D. did sign for FDA.
Perdue, who left Washington D.C. as the Trump Administration’s longest-serving cabinet member, said the MOU clears the way for agricultural animal biotechnology innovations. Perdue, 74, said the MOU “clears a path to bring our regulatory framework into the 21st century, putting American products on a level playing field with competitors around the world.
“In the past, regulations stifled innovation, causing American business 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 outlines regulatory responsibilities for the USDA and the FDA in the use of genetic engineering in animal development where agricultural purposes are involved such as for human food, fiber, or labor.
The USDA sees agricultural biotechnology as holding “tremendous potential” to improve animal health, enhance farm productivity, improve nutrition and even enhance the need for some animal health measures.
Until now, the USDA and the FDA have had overlapping jurisdictions. The MOU commits the two agencies to cooperate to promote the use of the “promising technology” in the name of encouraging innovation.
The MOU supports the USDA in the Advanced Notice of Proposed Rulemaking (ANPR) published Dec.28, 2020. It addresses the movement of animals developed or modified by genetic engineering.
The MOU supports the USDA’s regulatory framework for cattle, sheep, goats, swine, horses, mules, and other equines, along with catfish and poultry.
“Under this framework, USDA would safeguard animal and human health by providing end-to-end oversight from pre-market reviews through post-market food safety monitoring for certain farm animals modified or developed using genetic engineering that is intended for human food,” according to Perdue’s statement.
The MOU also allows for the transition of portions of the FDA’s pre-existing animal biotech regulatory authority to the USDA. The FDA would continue to review intentional genomic alterations intended for any purpose other than agricultural use. These include biopharma and non-heritable genomic alteration, and the regulation of dairy products and shell eggs, along with certain meat products and animal food derived from animals using genetic engineering.
The USDA first announced it wanted primary jurisdiction over gene-editing on Dec.21, 2020. Gene editing will be used to develop more disease-resistant animals, reduce antibiotic use, and cutback on environmental burdens. Those in the animal agriculture industry see the FDA’s involvement as burdensome because of the agency’s culture. As a result, other countries are said to be moving ahead of the U.S. in this technological area.
“The USDA has put forward an open and transparent process to establish regulatory certainty surrounding a promising technology,” says the National Pork Producers Council’s Howard “A.V.” Roth, a Wisconsin hog farmer.
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