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The 11-hour deal removes the FDA's oversight of GM animals

The 11-hour deal removes the FDA’s oversight of GM animals

“The FDA has no intention of waiving our public health mandate,” FDA Commissioner Stephen Hahn chirp Tuesday, after the USDA announced the deal.

The agency’s professional attorneys have already raised several objections to the so-called memorandum of understanding, people familiar with the discussions told Politico.

Hahn in recent days on several occasions refused to sign the agreement – including resisting pressure from HHS on Monday to agree to the MOU, according to a senior HHS official.

Instead, HHS Assistant Secretary of Health Brett Gerwier signed a Memorandum of Understanding in his place – a move that angered FDA officials who He spent months fighting HHS’s efforts to undermine the agency’s regulatory authority.

“This is one last moment, peace be upon you, Mary,” said the senior HHS official. “It is a complete waiver of FDA authority to the USDA.”

A HHS spokesman said the last-minute agreement was prompted by the White House, which orchestrated a “formal political process,” and came despite reservations by HHS Secretary Alex Azar.

The spokesman said that Azar “was and still supports the position of Commissioner Han and the Food and Drug Administration on the memorandum of understanding, but under the direction of the White House, the decision was taken to implement the memorandum of understanding.” The White House did not immediately respond to a request for comment.

Agriculture Minister Sonny Purdue was quick to praise the agreement, issuing a statement that it “paves the way for the introduction of our regulatory framework into the twenty-first century, placing American producers on a par with their competitors around the world. In the past, regulation stifled innovation, driving US companies” To catch up and give up market share. “

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It was a pork strip Leads the charge Of the plan on behalf of the USDA. The National Pork Producers Council, the industry’s largest lobbying group, said in a statement Tuesday that it plans to work with the Biden administration “to implement technology that has the potential to improve animal health, further reduce the environmental footprint of agriculture and improve production efficiency.”

After the FDA for years it was He resisted calls from the Agriculture lobby To cede its oversight, a request the industry paid for in part because they believe the USDA will give them approval more quickly. Throughout its history, the Food and Drug Administration has approved only two animals for productive consumption using these methods: Transgenic salmon And the Pigs are safe for people With some sensitivity.

In the face of mounting pressure to sign the agreement over the past week, Food and Drug Administration officials have argued that the agreement would violate the agency’s public health mission by ceding oversight of genetic modifications that could directly affect humans. The document, published on Tuesday, only requires the USDA to “consult” with the Food and Drug Administration in many cases, a vague requirement that the agency said would not stand up to legal scrutiny.

“With this MOU, the industry has beaten public health,” said the senior HHS official. “It’s a dark day for the agency.”