The Health and Human Services Department has agreed to an industry-backed plan to effectively strip the FDA of oversight of certain genetically modified animals — the latest instance of Trump political appointees overriding the agency’s scientists.
The deal announced Tuesday would shift regulatory authority to the USDA for reviewing the safety of animals produced for food using gene editing. The FDA would maintain oversight of a certain slice of gene edited products not related to agriculture, such as biopharma and gene therapies. The agency would also act in a “consultation” role as USDA develops and carries out its own regulations, per the agreement.
It’s a move that would fulfill a long-sought priority for the livestock industry and big businesses on the Trump administration’s final full day. Yet it comes after HHS overrode vehement objections from its own FDA, where officials had warned the agreement was illegal and could endanger public health.
"FDA has no intention of abdicating our public health mandate," FDA Commissioner Stephen Hahn tweeted Tuesday, after the USDA announced the agreement.
The agency’s career lawyers had already lodged several objections to the so-called memorandum of understanding, people with knowledge of the discussions told POLITICO.
Hahn in recent days refused on multiple occasions to sign off on the agreement — including resisting pressure from HHS on Monday to consent to the MoU, according to a senior HHS official.
Instead, HHS Assistant Secretary for Health Brett Giroir signed the MoU in his place — a move that further outraged FDA officials who have spent months fighting HHS efforts to erode the agency’s regulatory power.
"This is a last-minute Hail Mary," the senior HHS official said . "It is a total ceding of FDA authority to the USDA."
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An HHS spokesperson said the last-minute agreement was driven by the White House, which coordinated a “formal policy process,” and came despite HHS Secretary Alex Azar’s own reservations.
Azar "was and remains supportive of Commissioner Hahn’s and FDA’s position on the MOU, but at the direction of the White House, the decision was made to execute the MOU," the spokesperson said. The White House did not immediately respond to a request for comment.
Agriculture Secretary Sonny Perdue was quick to praise the agreement, releasing a statement that it “clears a path to bring our regulatory framework into the 21st century, putting American producers on a level playing field with their competitors around the world. In the past, regulations stifled innovation, causing American businesses to play catch-up and cede market share.”
The pork sector has been leading the charge for the plan on behalf of USDA. The National Pork Producers Council, the industry’s biggest lobbying group, said in a statement Tuesday that it plans to work with the Biden administration “to implement a technology that has the potential to improve animal health, further reduce agriculture’s environmental footprint and improve production efficiency.”
Yet the FDA for years had resisted calls from the agriculture lobby to cede its oversight, a request the industry has pushed for in part because they believe the USDA would more quickly grant them approval. Throughout its history, the FDA has only signed off on two animals for consumption produced using these methods: genetically engineered salmon and pigs safe for people with a certain allergy.
In the face of rising pressure to sign the agreement over the last week, FDA officials argued the agreement would violate the agency’s public health mission by giving up oversight of genetic alterations that could directly affect humans. The document published Tuesday requires the USDA only to "consult" with the FDA in many cases, a vague requirement that the agency argued would not hold up to legal scrutiny.
“With this MoU, industry won over public health,” the senior HHS official said. “It’s a dark day for the agency.”