Federal Register - September 3, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Proposed Rules questions. To date, FSIS received one comment from a non-profit organization, conveying broad support for the petition.
G. U.S. Government Accountability Office Report The U.S. Government Accountability Office GAO recently completed a review to, in part, understand how much information on the commercial production of cultured meat and poultry is available to federal regulators, including FSIS.12 It found that federal regulators lack specific information on the technology being used, eventual commercial production methods, and composition of the final products. FSIS
hopes to receive such information in response to this ANPR, so that it can make informed decisions regarding the labeling of these products.
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II. Issues for Comment FSIS invites comment on the issues discussed in this ANPR to help inform future rulemaking on the labeling of products made using animal cell-culture technology. Specifically, FSIS seeks responses to the questions listed below.
Please explain the reasoning behind your responses in detail. Also, provide any data, studies, or other evidence that supports your response. To help FSIS
review comments efficiently, please identify the question to which you are responding by its associated number and letter e.g., 2a or whether you are commenting on a topic not listed below.
1. 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?
2. What terms, 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.
a. How do these terms inform consumers of the nature or source of the product?
b. What are the benefits or costs to industry and consumers associated with these terms?
c. 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 cultured, would labeling differentiation be necessary to distinguish these products from other types of foods where the term culture or 12 U.S. Government Accountability Office, Food Safety: FDA and USDA Could Strengthen Existing Efforts to Prepare for Oversight of Cell-Cultured Meat, April 2020, available at: https www.gao.gov/
products/gao-20-325.
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cultured is used such as cultured celery powder?
3. 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?
4. What terms, 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.
5. What terms, 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.
6. 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?
a. If so, is additional qualifying language necessary? What qualifying terms or phrases would be appropriate?
b. Do these names, with or without qualifying language, clearly distinguish foods comprised of or containing cultured animal cells from slaughtered products?
7. 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?
a. Under what circumstances should these terms be used?
b. What information would these terms convey to consumers?
8. Should FSIS establish a regulatory standard of identity under its authorities in the FMIA and the PPIA 21 U.S.C. 607c and 457b for foods comprised of or containing cultured animal cells?
a. If so, what would be the standard and how might compliance with the standard be verified?
b. 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.
c. 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.
d. If so, what are the consumer benefits and costs to the standard of identity recommended?
9. 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?
10. Should any of the definitions for meat, meat byproduct, or meat food
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product found in 9 CFR 301.2 be amended to specifically include or exclude foods comprised of or containing cultured animal cells?
11. 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?
12. 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?
13. 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?
14. 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?
III. Request for Economic Data and Consumer Research Along with the above questions about the costs and benefits of labeling options for cell cultured meat and poultry, FSIS seeks 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 is particularly interested in information regarding: 1
The impact of the labeling of cell cultured meat and poultry on consumers perception of and willingness to pay for cultured meat and poultry products; 2 the expected price per pound of cultured meat and poultry products; for example, FSIS has reviewed recent studies that discuss consumer perception 13 and willingness to pay 14 for cultured meat products; 2
the expected price per pound of cultured meat and poultry products; 3
the number of domestic and the number of international animal cell culture technology companies estimated to enter the U.S. market for example, FSIS
is aware of eight domestic companies who belong to the Alliance for Meat, Poultry and Seafood Innovation AMPS
13 Kantor, Bella Nichole, Kantor, Jonathan. Public Attitudes and Willingness to Pay for Cultured Meat:
A Cross-Sectional Experimental Study. Frontiers in Sustainable Food Systems. Volume 5 2021 pg 26.
Accessed on June 22, 2021: https
www.frontiersin.org/articles/10.3389/
fsufs.2021.594650/full.
14 Rolland NCM, Markus CR, Post MJ. The Effect of Information Content on Acceptance of Cultured Meat in a Tasting Context. PLOS ONE 154:
e02311762020 Accessed on June 22, 2021: https
journals.plos.org/plosone/article?id=10.1371/
journal.pone.0231176.
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