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Regulatory Watch

Regulatory Watch

Shared regulatory approach for livestock, poultry cell-cultured products

Regulatory Watch
May 20, 2019

USDA’s FSIS and FDA released a formal agreement to address the regulatory oversight of human food products derived from the cells of livestock and poultry, which describes the oversight roles and responsibilities for both agencies and how they will collaborate to regulate the development and entry of these products into commerce. This shared regulatory approach will ensure that cell-cultured products derived from the livestock and poultry cell lines are produced safely and are accurately labeled.

Under the formal agreement, the agencies establish 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 production and labeling of human food products derived from livestock and poultry cells.

From Oct. 23-24, 2018, FSIS and FDA held a public meeting to discuss the use of cell culture technology. The meeting focused on the potential hazards, oversight considerations and labeling of cell-cultured food products derived from livestock and poultry.

Visit www.fsis.usda.gov or www.fda.gov to view the agreement. The recorded webinar from the public meeting is available on the FSIS website.

KEYWORDS: FDA FSIS meat products regulations USDA

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