FSIS Seeks Public Comments on the Labeling of Cultured Animal Cells

Background

• FSIS is the federal agency that, under the authority of the Federal Meat Inspection Act or the Poultry Products Inspection Act, protects public health by ensuring that meat and poultry products are not adulterated, and properly labeled.  On March 7, 2019, the U.S. Food and Drug Administration (FDA) and FSIS entered into a formal agreement to jointly oversee the production of human food products comprised of or containing cultured cells from animal species that are under FSIS’ jursidiction.  Under the agreement, FDA oversees the collection, growth and differentiation of livestock and poultry cells until cell harvest.  A transition from FDA to FSIS oversight will occur during the cell harvest stage.   FSIS will then oversee the processing, packaging, and labeling of the resulting meat and poultry products made using animal cell culture technology.

• Both agencies have expressed interest in how these products would be labeled.  On October 7, 2020, FDA published a Request for Information (RFI), similar to this ANPR, soliciting comments on the labeling of seafood products under their jurisdiction and made using animal cell culture technology.¹ FSIS’s ANPR solicits similar comments for products falling under FSIS’s jurisdiction.

Label Review Prior to Rulemaking

The ANPR contemplates that FSIS-regulated products made using animal cell culture technology may reach the market before FSIS can complete rulemaking on product naming.  FSIS specifically explains that the labels for these products would need to be submitted to FSIS for sketch approval before being used in commerce.  The ANPR indicates that, when reviewing labels, “FSIS will ensure the labels clearly differentiate cell cultured product from slaughtered meat and poultry products” in addition to ensuring that other label elements comply with FSIS requirements.  FSIS also cautions that “labels approved for cell cultured meat and poultry products prior to the conclusion of this rulemaking may need to be changed for compliance with the requirements of final regulations.”

Issues for Comment

In this ANPR, FSIS invites public comments on the specific questions listed below, which the agency noted should be also supported by any applicable data, studies, or other evidence.

• 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 sub-listing, 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?

Next steps

We will continue to monitor the legal and regulatory developments related to cultured animal cells.  If you have any questions in the meantime, please don’t hesitate to contact us.

References

1. FDA, “Labeling of Foods Comprised of or Containing Cultured Seafood Cells; Request for Information” 85 FR 63277 (October 7, 2020).

Authored by Brian D. Eyink and Xin Tao.