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Federal agencies regulate cell-cultured products from livestock

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The Food Safety and Inspection Service (part of the USDA) and the Food and Drug Administration today announced a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry. This shared regulatory approach will ensure that cell-cultured products derived from the cell lines of livestock and poultry are produced safely and are accurately labeled.

The FSIS and FDA released a formal agreement to address the regulatory oversight of human food produced using this new technology. The formal agreement describes the oversight roles and responsibilities for both agencies and how the agencies will collaborate to regulate the development and entry of these products into commerce. 

“Consumers trust the USDA mark of inspection to ensure safe, wholesome and accurately labeled products,” said USDA Deputy Under Secretary for Food Safety Mindy Brashears. “We look forward to continued collaboration with FDA and our stakeholders to safely regulate these new products and ensure parity in labeling.”

“We recognize that our stakeholders want clarity on how we will move forward with a regulatory regime to ensure the safety and proper labeling of these cell-cultured human food products while continuing to encourage innovation,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response.

United States Cattlemen’s Association President Kenny Graner said, “We are encouraged by USDA and FDA preemptively formalizing a joint regulatory framework prior to the commercialization of these products. Further, we’re pleased with language in the formal agreement that will allow USDA FSIS pre-market labeling authority.”

Although pleased USCA had some drawbacks. “However, we’d like to reiterate our position that the term ‘meat’, and more specifically ‘beef’, refers to products derived exclusively from the flesh of a bovine animal harvested in the traditional manner. Under the formal agreement, it appears that USDA FSIS will issue the USDA meat inspection stamp to be used on these products.”

Graner continued, “USCA is strongly opposed to the utilization of any of the three purple-inked USDA meat inspection stamps for cell-cultured product. A new stamp should be created for cell-cultured products that is inspected by USDA and by state inspection agencies, using a different format and color ink on the stamp. Neither the Federal or State meat inspection stamps should appear on the cell-cultured protein products, retail packaging or wholesale containers.”

To view the Formal Agreement, visit the FSIS website. Under the formal agreement, the agencies agree upon a joint regulatory framework wherein FDA oversees cell collection, cell banks, and cell growth and differentiation. A transition from FDA to FSIS oversight will occur during the cell harvest stage. FSIS will oversee the production and labeling of human food products derived from the cells of livestock and poultry.

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