Industry Concerned with FDA Oversight of Animal Genomics

Brian German Agri-Business, Regulation

Industry members are pushing for the U.S. Department of Agriculture (USDA) to assume regulatory oversight from the U.S. Food and Drug Administration (FDA) when it comes to animal genomics.  In a teleconference led by the National Pork Producers Council (NPPC) researchers, veterinarians, producers, and industry experts discussed the challenges associated with the FDA’s regulation of gene editing (GE) technology.

animal genomics“No other country has approached regulation of GE technologies the same way that FDA is proposing.  Among our competitors in the ag biotech arena – Argentina, Brazil, and Canada in particular – have already adopted risk-based GE regulations that are far less onerous,” said NPPC Lead Counsel for Science and Technology Andrew Bailey.  “More broadly, many other countries and regions are looking to adopt this technology, recognizing the need to update their regulations to accommodate it.”

The opportunities afforded through GE technology include better disease resistance in animals, increased heat tolerance, and better overall animal welfare traits that could reduce the need for antibiotics.  The underlying concern with FDA maintaining its regulatory authority is how it would classify animals that are reared through GE methods.  FDA considers the genes of those animals as a pharmaceutical drug, and therefore under its regulatory purview.  “It stretches incredulity and no other country on earth is proposing to regulate editing as a drug,” said Alison Van Eenennaam, Animal Genomics and Biotechnology Specialist at the University of California, Davis. “It’s just kind of outlying with what’s being proposed in other countries.”

The NPCC has launched a campaign highlighting the need for USDA to oversee GE technology.  Industry members are concerned that such stringent regulations under the FDA framework will hinder further development of the technology, putting American producers at a disadvantage to other market competitors.  Agriculture Secretary Sonny Perdue appears to agree that USDA should be involved in the regulation of gene-edited animals, telling farmers at a recent event in Iowa that he would be discussing the issue with President Donald Trump.

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Brian German

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Ag News Director, AgNet West