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Senate budget chief wants USDA and FDA to provide more information on cell technology pact

2019-05-05 foodsafetynews

Tag: USDA FDA Enzi

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Senate Budget Committee Chairman Mike Enzi, R-WY, wants to know “how the U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) will implement a policy to oversee human food produced using animal cell technology that is derived from livestock and poultry cells.”

Enzi has written Secretary of Agriculture Sonny Perdue and Acting FDA Commissioner Norman E. Sharpless, demanding answers about the food technology that the Wyoming Senator says could be on supermarket shelves by 2021. He says it is important that a “clear and functional regulator framework be in place by that time.”

The April 24 letter to Perdue and Sharpless was released to the public by Enzi on April 29. It mentions the USDA-FDA agreement to jointly oversee cell cultured products, which was announced in November 2018.

The FDA will have oversight over cell collection, cell banks, and cell growth and differentiation. During the cell harvest stage, oversight will transition to USDA to oversee production and labeling of food products produced from cells collected from livestock and poultry.

“The framework provides more detail regarding how the agencies will define their roles with regards to oversight of this novel food technology and identify any statutory or regulatory changes the agencies deem necessary to effect intended regulatory oversight,” Enzi wrote.

The Senator says the release of the formal USDA-FDA agreement is a positive development, but it is “general in nature” and the public needs the “more extact specifications.

“For example, the formal agreement expands on the agencies’ November 2018 announcement that FDA oversight will transition to USDA oversight during the cell harvest stage,” Enzi wrote. “Specifically, it explains that FDA will at harvest, help coordinate the transfer of the regulatory oversight to (USDA), including, but not limited to providing information necessary for USDA to determine whether harvested cells are eligible to be processed into meat or poultry products that bear the USDA mark of inspection.”

The Senator says USDA will also coordinate the transfer of oversight by reviewing such information.

Enzi was first elected to the U.S. Senate in Wyoming in 1996. He is a former mayor of Gillette, WY, who also served for a decade in the Wyoming Legislature.

His letter to USDA and FDA asks for “a clear explanation” of plans for labeling “these novel food products” by USDA. Enzi also wants the two agencies to publish more information on their joint regulatory framework.

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