The FDA has long had jurisdiction over animal biotechnology, but USDA wants to take the reins.
The head of the Food and Drug Administration (FDA) is refusing to sign off on an agreement that would transfer oversight of genetically engineered livestock to the more industry-friendly Department of Agriculture (USDA), reviving a longstanding debate about how the new food technology should be regulated.
FDA Commissioner Stephen Hahn cited concerns about the legality and health consequences of such a move to FDA’s parent agency, the Department of Health and Human Services (DHHS), Politico reported.
Animal biotechnology has long been the jurisdiction of FDA: In mid-December, the agency approved the first-ever genetically engineered pig for human consumption and medical use, a development that could potentially produce pork for red meat allergy sufferers. Before that, it had approved a genetically engineered salmon, as well.
In mid-December, the agency approved the first-ever genetically engineered pig for human consumption and medical use.
But producers and gene editing companies repeatedly called for USDA to regulate the sector instead, arguing that FDA has been too slow to green-light new developments. They seem to have found a particularly sympathetic ear in the outgoing administration.
A few days before the new year, USDA began to solicit feedback on a proposal to take over regulation of genetically engineered livestock meant for food. Under the suggested framework, the agency would oversee “end-to-end regulatory oversight from pre-market reviews through post-market food safety monitoring for animals modified or developed using genetic engineering intended for use as human food.” It also said that the proposal was developed “in consultation with FDA.” (Apparently, FDA leadership does not feel very consulted.)
To pass the baton, USDA and FDA have to agree to what is called a “Memorandum of Understanding” that delineates each agency’s jurisdiction in the sector. Commissioner Hahn’s refusal to sign the memorandum is significant because it would block USDA from moving forward with its plans. (Neither USDA nor FDA responded to requests for comment by press time.)
“There’s a perception, that I think is real, that USDA is more accommodating for farmers and ranchers than FDA would be.”
In the past, producers have complained that FDA’s biotechnology approval process is overly cumbersome, a characterization echoed by both Secretary of Agriculture Sonny Perdue and President Donald Trump. In a press release published Thursday, the National Pork Producers Council characterized Hahn’s refusal as one of many “delay tactics that are holding back U.S. agriculture.”
But USDA’s proposal has raised some concerns that the agency is too friendly with the industry it wants to regulate, and that it wouldn’t adequately scrutinize the new technology.
“There’s a perception, that I think is real, that USDA is more accommodating for farmers and ranchers than FDA would be,” said Joe Grogan, head of the Domestic Policy Council under Trump and senior advisor at FDA under George W. Bush. “[USDA] has a marketing mission. In earlier policy discussions, it was always a tension: Is it appropriate to put a promoter in charge of something this complicated?”
“When you have the FDA commissioner saying he doesn’t agree, it casts doubt on the policy.”
Indeed, USDA is heavily involved with the promotion of agriculture, and has faced criticism in the past for being especially cozy with large meat processing companies—a concern that came up in the recent debate over cell-cultured meat regulation. (FDA and USDA now have joint oversight of the sector.)
Jaydee Hanson, policy director for the Center for Food Safety, doesn’t agree with FDA’s current approach of regulating edited genes as drugs, but said that animal biotechnology should remain under the purview of FDA. “Genetic engineering should be treated as a new food additive, which is why FDA should be looking at it.”
Some officials told Politico that they feared DHHS leadership, empowered by the White House, may go so far as to override Hahn’s refusal. Should the turf war over genetically engineered livestock escalate to that point, Grogan says, it could ultimately backfire on the sector.
“When you have the FDA commissioner saying he doesn’t agree, it casts doubt on the policy,” he said. “And it will ultimately cast doubt on the products.”