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Gene editing oversight clarification needed

Development of an emerging technology promising major animal health and environmental benefits is currently stalled at the U.S. Food & Drug Administration, prompting the National Pork Producers Council to renew its call for U.S. Department of Agriculture regulatory oversight of gene editing for livestock.

“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,” said Jim Heimerl, a pork producer from Johnstown, Ohio and president of the National Pork Producers Council. “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.

Dr. Dan Kovich, NPPC director of science and technology, is advocating for USDA oversight of gene editing. 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 a drug manufacturing facility — undermining U.S. agricultural competitiveness relative to other countries with more progressive gene editing regulatory policies.

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