The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and the U.S. Department of Health and Human Services’ (HHS) Food and Drug Administration (FDA) announced a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry.
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. 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.
“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. “Collaboration between USDA and FDA will allow us to draw upon the unique expertise of each agency in addressing the many important technical and regulatory considerations that can arise with the development of animal cell-cultured food products for human consumption.”
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.
On Oct. 23-24, 2018, FSIS and FDA held a 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.
Trade groups in the meat and poultry industry applauded the decision.
“The framework announced today will ensure cell-based meat and poultry products are wholesome, safe for consumption, and properly labeled,” said Meat Institute President and CEO Julie Anna Potts. “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.”
“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. NTF applauds the teams at USDA and FDA for their commitment to a joint process, and we look forward to working with both agencies moving forward. This is just the first of many steps in developing a regulatory framework, and NTF will continue to be an active voice in this discussion.”
To view the recorded webinar from the public meeting on the FSIS website at www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/past-meetings.
To view the Formal Agreement, visit the FSIS website at www.fsis.usda.gov/formalagreement or the FDA website at www.fda.gov/Food/InternationalInteragencyCoordination/DomesticInteragencyAgreements/UCM632752.htm.
Source: FSIS, NAMI, NTF
