On September 2, 2021, the U.S. Department of Agriculture’s Food Safety and Inspection Service (“FSIS”) published an advanced notice of proposed rulemaking to solicit comments from the public regarding the labeling of meat and poultry products made using cultured cells derived from animals. FSIS stated that it would use those comments to make further regulatory requirements.
FSIS also asked for economic data and consumer research to help increase its understanding of the animal cell culture technology industry and related issues regarding labeling and consumer perceptions of food made using this technology.
FSIS asked for public comment on the following fourteen questions:
- Should the product name of a meat or poultry product comprised of or containing cultured animal cells differentiate the product from slaughtered meat or poultry by informing consumers the product was made using animal cell culture technology? If yes, what criteria should the agency consider or use to differentiate the products? If no, why not?
- What term(s), if any, should be in the product name of a food comprised of or containing cultured animal cells to convey the nature or source of the food to consumers? (e.g., "cell-cultured" or "cell cultivated.")
- How do these terms inform consumers of the nature or source of the product?
- What are the benefits or costs to industry and consumers associated with these terms?
- If meat or poultry products comprised of or containing cultured animal cells were to be labeled with the term "culture" or "cultured" in their product names or standards of identity (e.g., "cell culture[d]"), would labeling differentiation be necessary to distinguish these products from other types of foods where the term "culture" or "cultured" is used (such as "cultured celery powder")?
- If a meat or poultry product were comprised of both slaughtered meat or poultry and cultured animal cells, what unique labeling requirements, if any, should be required for such products?
- What term(s), if used in the product name of a food comprised of or containing cultured animal cells, would be potentially false or misleading to consumers? For each term, please provide your reasoning.
- What term(s), if used in the product name of a food comprised of or containing cultured animal cells, would potentially have a negative impact on industry or consumers? For each term, please provide your reasoning.
- Should names for slaughtered meat and poultry products established by common usage (e.g., Pork Loin), statute or regulation be included in the names or standards of identity of such products derived from cultured animal cells?
- If so, is additional qualifying language necessary? What qualifying terms or phrases would be appropriate?
- Do these names, with or without qualifying language, clearly distinguish foods comprised of or containing cultured animal cells from slaughtered products?
- Should terms that specify the form of meat or poultry products (such as "fillet", “patty” or "steak") be allowed to be included in or to accompany the name or standard of identity of foods comprised of or containing cultured animal cells?
- Under what circumstances should these terms be used?
- What information would these terms convey to consumers?
- Should FSIS establish a regulatory standard of identity under its authorities in the FMIA and the PPIA (21 U.S.C. 607(c) and 457(b)) for foods comprised of or containing cultured animal cells?
- If so, what would be the standard and how might compliance with the standard be verified?
- If so, what would be the labeling terminology for products that do and do not meet a formal standard of identity? What would be the anticipated categories of use? For example, mechanically separated poultry that does not meet the standards of identity outlined in 9 CFR 381.173 may be diverted for production in broths and bases, as well as reaction flavors, i.e., flavors produced by the heating of the protein source in the presence of a reducing sugar.
- If so, what are the benefits and costs to industry if the standard of identity is established? Please provide quantitative and qualitative feedback in your response and explain the basis of any quantitative estimates.
- If so, what are the consumer benefits and costs to the standard of identity recommended?
- What nutritional, organoleptic (e.g., appearance, odor, taste), biological, chemical or other characteristics, material to consumers’ purchasing and consumption decisions, vary between slaughtered meat or poultry products and those comprised of or containing cultured animal cells?
- Should any of the definitions for “meat”, “meat byproduct” or “meat food product” found in 9 CFR 301.2 be amended to specifically include or exclude foods comprised of or containing cultured animal cells?
- Should any of the definitions for “poultry product” or “poultry food product” found in 9 CFR 381.1 be amended to specifically include or exclude foods comprised of or containing cultured animal cells?
- Should FSIS-regulated broths, bases and reaction flavors produced from cultured animal cells be required to declare the source material in the product name, ingredient sublisting or elsewhere on the label?
- Should the presence of cultured animal cells in further processed products regulated by FSIS, such as a lasagna made with cell-cultured beef cells as an ingredient, be qualified on the product label? If so, how should this be qualified?
- What label claims are likely to appear on FSIS-regulated products comprised of or containing cultured animal cells? Should FSIS develop new regulations or guidance on such claims to ensure they are neither false nor misleading?