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FDA sitting on gene editing development; USDA needs to oversee

FDA oversight will treat any gene-edited animal as a living animal drug — and every farm raising them as a drug manufacturing facility.

The development of gene editing for livestock is currently stalled at the U.S. Food and Drug Administration, prompting the National Pork Producers Council to renew its call for USDA regulatory oversight of the process.

“The pace of FDA’s process to develop a regulatory framework for this important innovation only reinforces our belief that the USDA is best equipped to oversee gene editing for livestock production,” says Jim Heimerl, a pork producer from Johnstown, Ohio, and president of the NPPC. “U.S. agriculture is one our nation’s most successful export products; we can’t afford to cede leadership of gene editing to other countries.”

Gene editing accelerates genetic improvements that could be realized over long periods of time through breeding. It allows for simple changes in a pig’s native genetic structure without introducing genes from another species. Emerging applications include raising pigs resistant to porcine reproductive and respiratory syndrome, a highly contagious swine disease that causes significant animal suffering and costs pork producers worldwide billions of dollars.

Dan Kovich, NPPC director of science and technology, will advocate today for USDA oversight of gene editing at an Innovations in Agriculture panel moderated by USDA Under Secretary Greg Ibach during the agency’s 95th Annual Agricultural Outlook Forum. According to Kovich, “In addition to dramatic animal health gains and reduced financial risk for farmers, gene editing’s promise includes less need to use antibiotics to care for livestock and reduced environmental impact from more efficient farm operations.”        

Despite no statutory requirement, the FDA currently holds regulatory authority over gene editing in food-producing animals. FDA oversight will treat any gene-edited animal as a living animal drug — and every farm raising them as a drug manufacturing facility — undermining U.S. agricultural competitiveness relative to other countries with more progressive gene editing regulatory policies.

Source: National Pork Producers Council, which is solely responsible for the information provided, and wholly owns the information. Informa Business Media and all its subsidiaries are not responsible for any of the content contained in this information asset.
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