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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Proposed Rules commerce. This includes labels that display special statements or claims.3
Special statements or claims include those not defined by regulation or policy, organic claims, health claims, ingredient and processing method claims, structure-function claims, animal-raising claims, and instructional or disclaimer statements concerning pathogens 9 CFR 412.1e.4
Establishments must provide FSIS with documentation and data to support special statements and claims for Agency review, or the labels will not be approved.
The labels for cell cultured products under FSIS jurisdiction will be subject to premarket review under the same process as other special statements or claims. This will ensure that labeling for products developed using cell culture technology are not false or misleading, that labeling requirements are applied consistently as these novel products enter the marketplace, and that the label provides the necessary product information for consumers to make informed purchasing decisions. FSIS
has provided for generic approval of labeling features, statements, and claims based on demonstrated prevalent industry understanding of the effective application of those features, statements, or claims and consumer understanding of labeling statements.
No widespread industry understanding of the labeling requirements for cell cultured meat and poultry products currently exists. Similarly, consumers have not yet had experience reading these types of labels.
B. Evaluating the Need for New Labeling Requirements FSIS has established numerous labeling requirements for meat and poultry products in response to, among other things, the advent of new methods of production. In assessing the labeling of meat and poultry products developed using new methods or technologies, the Agency typically focuses on the biological, chemical, nutritional, and organoleptic characteristics of the finished product. The statutory and regulatory definitions of meat and poultry are also pertinent.
Pursuant to 9 CFR 301.2, the term meat refers to the muscle of amenable lotter on DSK11XQN23PROD with PROPOSALS1

3 Other
types of labels that require prior review include labels for religious exempt products, labels for export with deviations from domestic labeling requirements, and labels for temporary approval 9
CFR 412.1c.
4 On September 14, 2020, FSIS published the Prior Label Approval System: Expansion of Generic Label Approval proposed rule, which proposes amendments to the generic labeling and special statements and claims provisions of 9 CFR part 412.
85 FR 56538.

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livestock that is skeletal or found in the tongue, diaphragm, heart, or esophagus, with or without the bone, skin, sinew, nerve, and blood vessels, which normally accompany such tissue and are not separated from it in the process of dressing. Meat does not include the muscle found in the lips, snout, or ears, or significant portions of bone or related components, or any amount of brain, trigeminal ganglia, spinal cord, or dorsal root ganglia.5 Any part of amenable livestock that is capable of use as human food, but does not qualify as meat, is a meat byproduct. Any article capable of use as human food that is made wholly or in part from any meat or other portion of amenable livestock is a meat food product 21
U.S.C. 601j.
Regarding poultry, the PPIA and its implementing regulations define the term poultry product as any poultry carcass or part thereof; or any product which is made wholly or in part from any poultry carcass or part thereof 21
U.S.C. 453f; 9 CFR 381.1. The term poultry food product refers to any product capable of use as human food which is made in part from any poultry carcass or part thereof 9 CFR 381.1.
If a new method of production or processing alters the biological, chemical, nutritional, or organoleptic properties of meat or poultry to the extent that the resulting product no longer aligns with consumers expectations, FSIS establishes new label requirements to ensure consumers expectations are met. For example, in 1995, FSIS evaluated the need to establish new labeling requirements for mechanically separated poultry MSP
60 FR 55962, November 3, 1995. FSIS
found that this novel method of deriving poultry products using the mechanical separation process resulted in a product whose physical form, texture, and ingredients, e.g., bone content, differ materially from those of other boneless poultry products produced by hand deboning techniques. FSIS therefore established a new standard of identity for MSP 9 CFR 381.173 to ensure consumer expectations are met.
Conversely, in 2004, FSIS evaluated the need to establish new labeling requirements for meat derived using advanced meat recovery AMR systems 5 Specified
risk materials SRMs are inedible and must be removed from all cattle presented for slaughter in accordance with 9 CFR 310.22. SRMs include the brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum, and dorsal root ganglia from cattle 30
months of age and older 9 CFR 310.22a1. SRMs also include the distal ileum of the small intestine and the tonsils from all cattle 9 CFR 310.22a2.

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69 FR 1874, January 12, 2004. There, FSIS found that AMR product was comparable to meat derived by hand deboning in terms of its composition, appearance, and texture so long as it was produced in accordance with the regulations. FSIS therefore did not need to establish new labeling regulations for AMR products to meet consumer expectations. Instead, the Agency set compositional criteria for AMR products and modified the definition of meat to make it clear that boneless meat products, such as AMR products, may not include a significant portion of bone or related components 9 CFR 318.24.
C. FDAFSIS Joint Agreement Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived From Cell Lines of USDA-Amenable Species On March 7, 2019, the Food and Drug Administration FDA and FSIS signed a formal agreement to jointly oversee the production of human food products comprised of or containing cultured cells derived from cell lines of those species covered under the Acts.6 The agreement describes each agencys intended role with respect to the oversight of such products. In summary, FDA will oversee 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.
FDA will continue to have the sole responsibility to regulate foods for animals, as well as for those foods for humans comprised of or containing cultured animal cells from species under FDAs jurisdiction, i.e., those not amenable to the FMIA or PPIA, such as seafood species other than Siluriformes fish.7 In the formal agreement, FSIS and FDA have agreed to develop joint principles for product labeling and claims to ensure that FDA and FSIS
regulated products are labeled consistently and transparently and work developing those principles is continuing. On October 7, 2020, FDA
published a Request for Information 6 Formal agreement between the U.S. Department of Health and Human Services Food and Drug Administration and U.S. Department of Agriculture Office of Food Safety Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDAamenable Species, March 7, 2019, available at https www.fsis.usda.gov/sites/default/files/media_
file/2020-07/Formal-Agreement-FSIS-FDA.pdf.
7 FDA also has jurisdiction over products with 3% or less raw meat or less than 2% cooked meat or poultry meat.

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