Welcome

Welcome

Friday, March 8, 2019

USDA and the Food and Drug Administration (FDA) have outlined their much-anticipated agreement for how the nascent cell-based meat industry would be regulated in the United States

In a joint release, the Food Safety and Inspection Service (FSIS) and FDA, a unit of the U.S. Department of Health and Human Services, said the formal agreement describes the oversight responsibilities for both agencies and how they will collaborate to regulate the development and entry of these products into commerce. The joint regulatory framework has FDA overseeing 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. 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 agencies said. “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.” Said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, “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.” Last October, FSIS and FDA held a sometimes-contentious joint public meeting to discuss the use of cell culture technology to develop products derived from livestock and poultry. The public meeting focused on the potential hazards, oversight considerations and labeling of cell cultured food products derived from livestock and poultry. To read the formal agreement, visit the FSIS website here. Response Industry representatives breathed a collective sigh of relief that the agreement finally had been reached. “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,” said United States Cattlemen’s Association (USCA) President Kenny Graner. The North American Meat Institute said it “appreciates the agencies’ collaborative efforts to establish a regulatory system that protects consumers, prioritizes product safety and fosters innovation. “We support a fair and competitive marketplace that lets consumers decide what food products make sense for them and their families, and this agreement will help achieve these goals by establishing the level playing field necessary to ensure consumer confidence,” said Meat Institute President and CEO Julie Anna Potts. Joint regulatory oversight of animal cell-cultured protein, with USDA regulating production and labeling, is the best path forward, said Joel Brandenberger, National Turkey Federation president. “Today’s formal agreement appears to address the concerns expressed by NTF members and other meat and poultry producers," he said. Good Food Institute Director of Policy Jessica Almy said the agreement “is a significant step forward in providing a transparent and predictable regulatory path to market for cell-based meat, which will help to ensure that the U.S. does not fall behind Israel, China, Japan, the Netherlands, Singapore and other countries that are moving quickly to ensure a clear path to market for this method of meat production.” Next steps Most of the groups also used the announcement also as an opportunity to remind members of other lingering priorities. “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," USCA’s Graner said. "Under the formal agreement, it appears that USDA FSIS will issue the USDA meat inspection stamp to be used on [cell-based] products. “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 (are) 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.” National Cattlemen’s Beef Association President Jennifer Houston, “The formal agreement announced today solidifies USDA’s lead oversight role in the production and labeling of lab-grown fake meat products. … We look forward to working collaboratively with the USDA and FDA on next steps, including the development of a more detailed framework concerning the cell harvest stage.” GFI’s Almy said with leadership at the federal level, "there is no need for states to pass legislation that would censor these labels before cell-based meat even comes to market.”