As readers of our blog know, FDA and the Food Safety Inspection Service of the USDA (FSIS) agreed to jointly oversee the production of human food products using animal cell culture technology. Under the Memorandum of Understanding signed in March 2019, FDA will oversee cell collection, growth, and differentiation of cells, and help coordinate transfer of oversight to FSIS at the cell harvest stage. FSIS will then determine whether harvested cells are eligible to be processed into meat or poultry products, and oversee processing, packaging, and labeling of those products.
FDA and FSIS also agreed to develop joint principles for the labeling of products made using cell culture technology under their respective labeling jurisdictions. As we previously reported, FDA issued a request for information regarding labeling of products made using cell culture seafood cells in Oct. 2020.
On Sept. 2, 2021, FSIS issued an advance notice of proposed rulemaking (ANPR) asking for comment on several issues that will help the Agency develop a proposed regulation addressing labeling of cultured meat and poultry products. See here and here. (The ANPR does not appear to address Suliformes fish (including catfish)). Like FDA, FSIS uses the term “cultured” for this type of product. However, FSIS notes that the use of this term is not intended to establish or suggest nomenclature for labeling purposes.
FSIS requests input on a range of issues, including:
- Should the names of cultured products differ from those of slaughtered products?
- What terms should be used to differentiate cultured products?
- What terms would be potentially false/misleading or have negative impacts on consumers or the industry?
- Should it be permissible to use established names of slaughtered products (e.g., loin) or terms that specify form (e.g., fillet)?
- Should USDA establish a standard of identity for cultured products?
- What are the material differences between cultured and slaughtered products?
- Should meat and poultry-related definitions be amended to include or exclude cultured products?
FSIS also asks for economic data and consumer research regarding cultured products, including:
- impact of labeling on consumer perception and willingness to pay for cultured products;
- expected price of cultured products;
- number of companies in the sector;
- expected annual volume per company;
- data on consumer benefits of labels that differentiate cultured from slaughtered products;
- naming conventions that would discourage purchase or innovation.
FSIS mentions that it will consider comments submitted in response to FDA’s RFI as FSIS develops rules governing the labeling of cell cultured products under its jurisdiction, to the extent those comments are relevant to the development of joint labeling principles.
FSIS indicates that it is willing to review labels for cultured products before its rulemaking process is complete. Labels for such products must be submitted for review and approval by FSIS so the Agency can prevent false or misleading labeling. Although this will help industry avoid delays associated with rulemaking, labels approved during the interim (pre-final rule) period may need to be modified once FSIS finalizes the rule.
FSIS mentions that it does not plan to issue any other regulation addressing other aspects of cultured meat/poultry products (e.g., safety) because the existing regulatory requirements, including sanitation and Hazard Analysis and Critical Control Point (HACCP) systems, are immediately applicable and sufficient to ensure the safety of products cultured from the cells of livestock and poultry.
Comments may be submitted to the docket here through Nov. 2, 2021.