Source: Tom Johnston, MEATINGPLACE, 5/3/19


That the U.S. Food and Drug Administration (FDA) is hiring more scientists to evaluate development of animal biotechnology does not bode well for livestock groups like the National Pork Producers Council (NPPC) that are clamoring for USDA jurisdiction over gene-edited animals.

FDA Acting Commissioner announced the agency’s push on Thursday at the Food and Drug Law Institute’s annual conference in Washington D.C. He also said that FDA is looking to release additional guidance on the topic.

FDA must “make sure that the genetic modification is safe to the animal, that it does what it’s supposed to do and that any food-producing animal is safe to eat,” Sharpless was quoted as saying in a keynote speech at the FDLI conference.

NPPC has criticized FDA’s management of the technology, saying its regulatory red tape is slowing the pace of its development at the risk of U.S. agriculture’s competitiveness in the global market. Specifically, the pork group contends FDA oversight treats any gene-edited animal as a living animal drug — and every farm raising them a drug manufacturing facility. 

FDA officials have refuted NPPC's argument.

“It’s important to clarify that the FDA is not regulating an animal as a drug. Rather, the agency regulates the intentional genomic alteration in the animal, not the animal itself,” former FDA Commissioner Scott Gottlieb said in a recent statement updating the agency’s approach to animal biotechnology. “We don’t consider farmers or producers who simply purchase and raise animals with intentional genomic alternations to be drug manufacturers or their farms to be drug-manufacturing sites in the traditional sense of those terms. And we won’t use nomenclature that could wrongly imply that the animals or the farms should be classified that way.

Similarly, performing post-market surveillance is generally a requirement for sponsors of approved applications, not an obligation for farmers or producers.”

Nonetheless, NPPC had fresh criticism following Sharpless’s latest comments on the issue.

"The FDA's regulatory framework for gene edited livestock will seriously damage U.S. agriculture by virtually ensuring that this breakthrough technology is ceded to foreign competitors," Dan Kovich, NPPC's director of science and technology, told POLITICO. 

"The FDA's regulatory land grab flies in the face of positive regulatory reform by the Trump administration."
Gene editing accelerates genetic improvements that could be realized over long periods of time through breeding, NPPC notes. It allows for simple changes, for example, 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.

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