FDA oversight won’t unlock gene editing potential | Michigan Farm News

FDA oversight won’t unlock gene editing potential

Category: Opinion

by National Pork Producers Council

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NPPC urges the Trump administration to move regulatory oversight of gene editing in animals from the FDA to the USDA’s Animal and Plant Health Inspection Service.

Gene editing holds tremendous food safety, animal health and welfare promise for U.S. pork. It is an emerging innovation that allows for simple changes to be made within a pig’s native genetic structure without introducing genes from other species.

Gene editing simply accelerates genetic improvements that could be realized naturally over time through breeding. Emerging applications include the use of gene editing to produce pigs resistant to Porcine Reproductive and Respiratory Syndrome, a highly contagious swine disease that causes significant animal suffering and has cost pork producers worldwide billions of dollars.

Despite the lack of any statutory requirement, the FDA currently holds regulatory authority over gene editing in food producing animals. As a result, an animal health breakthrough that will dramatically enhance animal care and food safety and support economic prosperity in rural America faces an impractical, lengthy and expensive approval process that will render it unavailable to American farmers while countries around the world realize its potential.

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.

NPPC urges the Trump administration to move regulatory oversight of gene editing in animals from the FDA to the USDA’s Animal and Plant Health Inspection Service. APHIS, which already regulates gene editing in plants, can ensure a proper, risk-based regulatory review under the Animal Health Protection Act.

“It’s deeply disturbing to U.S. pork producers to see the FDA adopt a Luddite-like regulatory approach that threatens the global competitiveness of U.S. agriculture,” said Heimerl.

“Common sense regulations have helped make U.S. pork the global leader, and we can’t afford to cede such an important innovation to the rest of the world.”