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USDA, FDA to jointly regulate cell-cultured meat

FDA to regulate cell stage, while USDA controls production/labeling

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USDA and FDA have formally agreed to jointly regulate cell-based meat, and USDA Secretary Sonny Perdue and FDA Commissioner Scott Gottlieb said Friday (Nov. 16) no new legislation is needed to make it work.

The two leaders with oversight of the U.S. food supply hinted that there was a role for both agencies to play in regulating cell-based meat at last month’s USDA-FDA meeting.

The regulatory pathway for these products has been a nagging question, along with an elusive agreement on terminology, that has caused roadblocks for the startup companies and dissention within the government on how to proceed.

There were early reports the two agencies wrestled over control of regulating cell-cultured meat, and the issue has spilled over to Congress, as the current appropriations bill for USDA/FDA, which is on the agenda for the lame duck session, would hand the controller over to USDA to exclusively regulate these products.

Now FDA and USDA have issued a joint statement that makes clear to lawmakers and lobbyists there is an agreement on the path forward in regulating cell-cultured meat.

“After several thoughtful discussions between our two Agencies that incorporated this stakeholder feedback, we have concluded that both the USDA and the FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry,” Perdue and Gottlieb said Friday.

“Drawing on the expertise of both USDA and FDA, the Agencies are today announcing agreement on a joint regulatory framework wherein FDA oversees cell collection, cell banks, and cell growth and differentiation,” they said.

Not surprisingly, the “bright line” Perdue said he was seeking at the USDA/FDA meeting occurs after the cell harvest stage when USDA would be overseeing production and labeling for the new product.

“A transition from FDA to USDA oversight will occur during the cell harvest stage. USDA will then oversee the production and labeling of food products derived from the cells of livestock and poultry. And, the Agencies are actively refining the technical details of the framework, including robust collaboration and information sharing between the agencies to allow each to carry out our respective roles,” they said.

The two agencies said the framework will tap FDA’s experience in regulating cell-culture technology and living biosystems, while relying on USDA’s expertise in regulating livestock and poultry products.

“USDA and FDA are confident that this regulatory framework can be successfully implemented and assure the safety of these products,” Perdue and Gottlieb said.

And the two agencies sent a message to lawmakers that no new legislation is needed to go forward with regulating these products.

“Because our agencies have the statutory authority necessary to appropriately regulate cell-cultured food products derived from livestock and poultry, the Administration does not believe that legislation on this topic is necessary.”

Sen. Pat Roberts (R-Kan.), chairman of the Senate Agriculture Committee, praised FDA and USDA for finding a “workable solution.”

“It seems Secretary Perdue and Commissioner Gottlieb listened to stakeholders and developed a workable solution. I’m pleased that USDA and FDA worked together on a proposal for regulation of these products that is respectful to the producer and the consumer,” Roberts said.

The National Cattlemen’s Beef Association (NCBA) said it was a “step in the right direction,” but suggested more work needs to be done and the fight to level the playing field between the new upstarts and conventionally raised meat is far from over.

“This announcement that USDA would have primary jurisdiction over the most important facets of lab-produced fake meat is a step in the right direction, but 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,” said Colin Woodall, NCBA’s senior vice president of government affairs.

“We look forward to continuing our work with the Administration and Congress as this moves forward, and we continue to encourage producers to file official comments with USDA and FDA between now and December 26th.”

Memphis Meats says news brings products 'one step closer to your plates'

News of the agreement was warmly received by Memphis Meats and the Good Food Institute (GFI).

The regulatory plan announced by Perdue and Gottlieb mirrored comments from Memphis Meats’ Eric Schulze at a recent meeting, where he suggested FDA could use its cell-based field expertise to regulate the product until it’s “harvested.” Once the product is developed into a meat tissue, USDA should take over regulation, applying its long-standing expertise in ensuring the safety of meat, said Schulze, Memphis Meats’ vice president of product and regulation.

In response to the latest news, the company tweeted their products were “one step closer to your plates” when the agencies provided “a clear path forward for cell-based meat.”

Memphis Meats’ poultry and beef is expected to reach the market by 2021, while the Netherlands-based Mosa Meat says it plans to start selling cell-based hamburgers within the next one or two years.

JUST, Inc. also praised the move. “We commend FDA Commissioner Gottlieb and USDA Secretary Perdue for their commitment to creating a regulatory framework for cultured meat and we look forward to working with both agencies.”

GFI Policy Director Jessica Almy called the agreement an “exciting indication that FDA and USDA are clearing the way for a transparent and predictable regulatory path forward.”

Almy agreed that no new laws or regulations are needed to oversee the cell-based meat industry and said she looked forward to working with the two agencies on guidance to build out the framework.

“We are confident that together the USDA and FDA will ensure that cell-based meat and poultry are safe for consumers and appropriately labeled. We look forward to the day in the not-so-distant future when American families will be sitting down to a dinner of meat made directly from cells, courtesy of this new industry that Commissioner Gottlieb and Secretary Perdue helped make possible,” Almy said.

She also noted the marketing potential of these products and the role U.S. regulators are playing in promoting the commercialization of cell-based meat.

“The governments of Israel, Japan, and Singapore have already signaled significant interest in this important food technology, and so we share FDA’s and USDA’s commitment to ensuring a clear regulatory path forward for cell-based meat as quickly as possible.”



 
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