The Department of Agriculture and the Food and Drug Administration will share regulatory oversight of cell-cultured meat products, Ag Secretary Sonny Perdue and FDA Commissioner Scott Gottlieb said today.
The declaration comes after lengthy debate over which agency was best positioned to regulate the technology, which produces foods derived from animal cells grown in a laboratory environment rather than from traditional production agriculture.
“This regulatory framework will leverage both the FDA’s experience regulating cell-culture technology and living biosystems and the USDA’s expertise in regulating livestock and poultry products for human consumption,” Perdue and Gottlieb said in a joint statement. “USDA and FDA are confident that this regulatory framework can be successfully implemented and assure the safety of these products.”
According to Perdue and Gottlieb, FDA will oversee “cell collection, cell banks, and cell growth and differentiation.” Once the process transitions over to the harvest stage, oversight will switch to USDA, which will supervise “the production and labeling of food products derived from the cells of livestock and poultry.”
The two agencies are “actively refining the technical details of the framework,” the two leaders said. Sufficient regulatory authority already exists, Perdue and Gottlieb insist, so “the Administration does not believe that legislation on this topic is necessary.”
A joint approach has been suggested before, including in a joint letter from the North American Meat Institute and cultured meat producer Memphis Meats. In a letter to the White House in August, the two entities suggested both USDA and FDA oversight, saying such a framework “is not new and plays into the strengths and experience of FDA and USDA.”
Perdue told reporters in October he thought the letter from the two groups “had it right.”
“I think we can go a long way between FDA and USDA in resolving how we move forward quickly,” he said in a media availability after addressing NAMI members in Washington. “The main thing is we don’t want this new technology to feel like they’ve got to go offshore outside the United States to get a fair regulatory protocol.”
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Uma Valeti, CEO and co-founder of Memphis Meats, offered a statement commending Perdue and Gottlieb for the approach.
"This regulatory framework plays to the respective strengths of both USDA and FDA, while continuing to foster innovation and assure a safe and reliable food system," he said. "We look forward to providing additional input as this process continues."
Colin Woodall, chief lobbyist for the National Cattlemen's Beef Association, called the joint approach with USDA having "primary jurisdiction over the most important facets" of the process "a step in the right direction." He added there is " there is still a lot of work to do on this issue to ensure that real beef producers and consumers are protected and treated fairly."
USDA and FDA held a joint meeting in Washington last month to examine the technology and the challenges posed by it. A comment period stemming from that meeting will be extended to Dec. 26.
(Story updated to include additional reaction.)
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