Currently, the FDA regulates the genetic modification of livestock
By Jackie Clark
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 Farms.com. 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.
“Meanwhile, the rest of the world is moving forward with already developed or are developing very common-sense, practical regulatory schemes that aren’t saddled with that drug designation,” he said. As a result, those countries should be able “to move forward with introducing some of those gene edits,” Kovich said.
That situation puts the U.S. at a competitive disadvantage, he added. Most countries have or are forming a unified strategy for both plants and animals with gene edits.
“It’s going to be to our detriment as a country if we have two systems for plants and animals as we try to export agricultural products around the world. … Having a common agricultural policy under one agency will be critical if this technology is going to be a boon to farmers and consumers,” Kovich said.
The NPPC hopes the government can transfer regulatory jurisdiction of gene-edited livestock to the USDA.
“We’d really like to see swift action by the administration that has the authority to affect this change to get it done,” Kovich said. “We want to be clear; we’re not asking for this to be deregulated … we want these edits subject to regulatory review, that’s important.”
Applications of gene-editing could benefit the livestock industries.
“As a veterinarian, what’s got me most excited is having (gene editing) as a new tool to combat viral diseases,” Kovich explained. Research indicates, for example, that an edit may be effective at controlling porcine reproductive and respiratory syndrome.
“That is a really good example of this technology already having experimentally … been shown to work,” he added. Other potential applications include combatting more viral diseases and improving food safety.
“There are researchers out there who have said they just don’t see a path forward with this current regulatory framework,” Kovich explained.
It comes down to a lack of acknowledgement that new tools differ from old methodologies.
“We really need a regulatory system that recognizes that and takes it into account. So far, the FDA has failed to do so,” he said.
konglinguang\iStock\Getty Images Plus photo