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NPPC Wants USDA to Control Gene Editing
USAgNet - 10/14/2020

A producer group is calling for a change in how gene-edited livestock are regulated in the United States. Currently, while the U.S. Department of Agriculture (USDA) has purview over plants, the Food and Drug Administration (FDA) controls genetic editing of livestock.

"We're obviously hoping that will change and change quickly," Dr. Dan Kovich, DMV, told He's the director of science and technology for the National Pork Producers Council (NPPC).

The separation of jurisdiction "dates back to a decades-old decision made by the executive branch to split authority, giving plants to the USDA and animals to the FDA," he explained.

At that time, genetic tools were cruder and "the only applications (in animals) were human biomedical research," he added. For that reason, it made sense for the FDA to regulate their use.

However, now "gene editing is so precise and accurate. We're not taking genes from other species, for example, and trying to put them into farm animals. It's just making small tweaks within the animal's own genome," Kovich explained.

In the swine industry, "you could try to achieve those things through natural breeding but that would take so long and potentially introduce backslide on other pork genetic achievements that we've made. So, it's just not something that you could feasibly do, and that's why we're so excited about gene editing."

However, the FDA regulations have stalled progress on this front.

"The current situation at the FDA is that (officials) are regulating this technology as if it were a drug," Kovich explained. Regulations apply to the altered genome and "the animal is indistinguishable from its genetic material."

Those rules would therefore have strict implications for gene-edited livestock, as well as farms and other production facilities.

"The drug approval process is lengthy and expensive," Kovich added. "In real terms, it's pretty much put a damper on this technology."

Researchers in the U.S. are dealing with the consequences and implications of this drug designation.

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