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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Proposed Rules
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Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS
20200036. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to https
www.regulations.gov.
Docket: For access to background documents or comments received, call 202 7205627 to schedule a time to visit the FSIS Docket Room at 1400
Independence Avenue SW, Washington, DC 202503700.
FOR FURTHER INFORMATION CONTACT:
Rachel Edelstein, Assistant Administrator, Office of Policy and Program Development by telephone at 202 2050495.
SUPPLEMENTARY INFORMATION:
I. Background This ANPR concerns the labeling of meat and poultry products produced using animal cell culture technology, including how these products are to be identified and described specifically in regard to their nature, source, or characteristics. Animal cell culture technology is a process that involves taking a small number of cells from living animals and growing them in a controlled environment to create food, among other things. Scientists typically start with a sample of cells from the tissue of an animal, some of which are selected, screened, and stored for future use. Later, some of these stored cells are retrieved and placed in a controlled environment with appropriate nutrients and other factors to support growth and cellular multiplication. After the cells have multiplied, additional inputs such as growth factors, new surfaces for cell attachment, and additional nutrients are added to the controlled environment to enable the cells to differentiate into various cell types. Once produced, the harvested cells can be processed, packaged, and marketed in the same, or similar, manner as slaughtered 1 meat and poultry products. This ANPR refers to such foods as cultured meat and poultry products or as products compromised of or containing cultured animal cells. The use of this term, however, is not intended to establish or suggest nomenclature for labeling purposes.
Many companies, both domestic and foreign, are currently developing cultured products derived from the cells of food animals amenable to the Federal Meat Inspection Act FMIA; 21 U.S.C.
1 This ANPR refers to all meat or poultry products not produced using animal cell culture technology as slaughtered meat and poultry products.

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601 et. seq. cattle, sheep, swine, goats, and fish of the order Siluriformes, e.g., catfish or the Poultry Products Inspection Act PPIA; 21 U.S.C. 451 et seq. chickens, turkeys, ducks, geese, guineas, ratites, and squabs. Human food products derived from these species hereinafter meat and poultry products fall under FSIS jurisdiction.
Under the FMIA and PPIA hereinafter the Acts, FSIS regulates the labeling of all meat and poultry products under its jurisdiction to ensure such products are not misbranded 21 U.S.C. 607d and 457c. FSIS is now seeking comments to inform future regulatory requirements for the labeling of cultured meat and poultry products intended to prevent misbranding.
A. FSIS Authority Over the Labeling of Cultured Meat and Poultry Products FSIS is the federal agency that, under the authority of the Acts, protects public health by ensuring that meat and poultry products are wholesome, not adulterated, and properly marked, labeled, and packaged. To that end, FSIS issues and enforces federal regulations to ensure, among other things, that meat and poultry products in commerce within the United States are not misbranded 21 U.S.C. 607d and 457c. With limited exceptions, U.S. states or territories may not impose requirements within the scope of the Actssuch as labeling requirements that are in addition to, or different from, the requirements established by the Acts or their implementing regulations 21
U.S.C. 678 and 476e.
B. Relevant Misbranding Provisions Under the Acts Under the Acts, a meat or poultry product is misbranded under a number of circumstances. In general, it is misbranded if its labeling is false or misleading in any particular 21 U.S.C.
601n1 and 453h1. It is also misbranded if it is offered for sale under the name of another food 21 U.S.C.
601n2 and 453h2 or if it is an imitation of another food, but not labeled as such 21 U.S.C. 601n3 and 453 h3.
A product is also misbranded if it purports to be or is represented as a food for which a standard of identity has been prescribed, without conforming to the standard 21 U.S.C.
601n7 and 453h7. FSIS has authority to establish standards of identity for meat and poultry products to help ensure such products have the characteristics expected by consumers 21 U.S.C. 607c and 457b. Standards of identity establish specific names, terms, and information to be used on
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product labels. Standards may also require the presence of certain expected ingredients in products, regulate the minimum or maximum amount of ingredients in products, or specify how products are formulated, processed, or prepared.
If a product is not covered by a standard of identity, it is misbranded unless its label bears the common or usual name of the food, if there is one, and the common or usual name of its ingredients 21 U.S.C. 601n9 and 453h9. Common or usual names are generally established by common usage but, in some cases, they may be established by regulation. In the absence of either a standard of identity or appropriate common or usual name, the product must be identified by a descriptive name 9 CFR 317.2e and 381.117a.
Words or statements that are required to appear on product labeling must be in terms likely to be understood by the ordinary individual under customary conditions of purchase and use 21
U.S.C. 601n6 and 453h6. In some instances, FSIS may require qualifying language to appear on product labels when necessary to ensure product names are not misleading. For example, a product identified as a turkey-ham, must be qualified with the statement cured turkey thigh meat 9 CFR
381.171.
C. FSIS Evaluation of Product Labels To prevent misbranded products from entering commerce, the Acts require FSIS to approve meat and poultry product labels before they may be used in commerce 21 U.S.C. 607d and 457c. To that end, FSIS implements a prior approval program for labels used on meat and poultry products 9 CFR
part 412. Under the program, labels that bear only mandatory labeling features 2, otherwise comply with the Agencys labeling regulations, and bear only claims that are defined in the regulations or are factual statements not considered a special statement or claim, are deemed generically approved and, thus, not subject to FSIS review before entering commerce. These labels are, however, subject to periodic compliance verification by FSIS inspectors in the field FSIS Directive 7221.1, Prior Labeling Approval.
FSIS must review and approve all other labels before they are used on products intended for distribution in 2 There are up to eight mandatory label features for each product label: 1 Product name, 2
inspection legend and establishment number, 3
handling statement, 4 net weight statement, 5
ingredients statement, 6 address line, 7 nutrition facts, and 8 safe handling instructions.

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