[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Proposed Rules]
[Pages 49491-49496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19057]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Chapter III

[Docket No. FSIS-2020-0036]
RIN 0583-AD89


Labeling of Meat or Poultry Products Comprised of or Containing 
Cultured Animal Cells

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing 
this advance notice of proposed rulemaking (ANPR) to request comments 
pertaining to the labeling of meat and poultry products comprised of or 
containing cultured cells derived from animals subject to the Federal 
Meat Inspection Act or the Poultry Products Inspection Act. Issues 
raised in the comments submitted in response to this ANPR will inform 
future rulemaking to establish labeling requirements for these 
products. This ANPR also discusses how FSIS will generally evaluate 
labels for these products if they are submitted before the Agency 
completes rulemaking.

DATES: Submit comments on or before November 2, 2021.

ADDRESSES: FSIS invites interested persons to submit comments on this 
document. Comments may be submitted by one of the following methods:
    <bullet> Federal eRulemaking Portal: This website provides the 
ability to type short comments directly into the comment field on this 
web page or attach a file for lengthier comments. Go to https://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
    <bullet> Mail: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 1400 Independence 
Avenue SW, Mailstop 3758, Washington, DC 20250-3700.
    <bullet> Hand- or courier-delivered submittals: Deliver to 1400 
Independence Avenue SW, Jamie L. Whitten Building, Room 350-E, 
Washington, DC 20250-3700.

[[Page 49492]]

    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2020-0036. 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) 720-5627 to schedule a time to visit the FSIS Docket Room at 
1400 Independence Avenue SW, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant 
Administrator, Office of Policy and Program Development by telephone at 
(202) 205-0495.

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.
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    \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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    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. 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. 607(d) and 457(c)). 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. 607(d) and 457(c)). 
With limited exceptions, U.S. states or territories may not impose 
requirements within the scope of the Acts--such 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. 601(n)(1) and 
453(h)(1)). It is also misbranded if it is offered for sale under the 
name of another food (21 U.S.C. 601(n)(2) and 453(h)(2)) or if it is an 
imitation of another food, but not labeled as such (21 U.S.C. 601(n)(3) 
and 453 (h)(3)).
    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. 601(n)(7) and 453(h)(7)). 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. 607(c) and 457(b)). Standards of identity 
establish specific names, terms, and information to be used on 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. 601(n)(9) and 453(h)(9)). 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 317.2(e) and 381.117(a)).
    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. 601(n)(6) and 
453(h)(6)). 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. 607(d) and 457(c)). 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 Agency's 
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).
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    \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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    FSIS must review and approve all other labels before they are used 
on products intended for distribution in

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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 412.1(e)).\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.
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    \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 412.1(c)).
    \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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    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 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. 601(j)).
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    \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 310.22(a)(1)). SRMs also include the 
distal ileum of the small intestine and the tonsils from all cattle 
(9 CFR 310.22(a)(2)).
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    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. 453(f); 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 (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. FDA-FSIS 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 agency's 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.
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    \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 
USDA-amenable Species, March 7, 2019, available at https://www.fsis.usda.gov/sites/default/files/media_file/2020-07/Formal-Agreement-FSIS-FDA.pdf.
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    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 FDA's 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

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(RFI), similar to this ANPR, soliciting comments on the labeling of 
seafood products under their jurisdiction and made using animal cell 
culture technology (Labeling of Foods Comprised of or Containing 
Cultured Seafood Cells; Request for Information; 85 FR 63277). FSIS 
will consider comments submitted in response to FDA's RFI as it 
develops rules governing the labeling of cell cultured products, to the 
extent they are relevant to the development of joint labeling 
principles and the regulation of meat and poultry.
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    \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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D. United States Cattlemen's Association Petition

    The United States Cattlemen's Association (USCA) filed a petition 
dated February 9, 2018, with FSIS regarding the labeling of cultured 
meat.\8\ The petition requests that FSIS limit the definition of 
``beef'' to products derived from cattle born, raised, and harvested in 
the traditional manner, and thereby prohibit foods comprised of or 
containing cultured animal cells from being labeled as ``beef.'' The 
petition similarly requests that FSIS limit the definition of ``meat'' 
to the tissue or flesh of animals that have been harvested in the 
traditional manner, and thereby prohibit foods comprised of or 
containing cultured animal cells from being labeled as ``meat.''
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    \8\ Petition 18-01 Submitted by the U.S. Cattlemen's 
Association, February 9, 2018, available at https://www.fsis.usda.gov/federal-register/petitions/petition-limit-definition-beef-traditional-sources.
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    FSIS received over 6000 comments \9\ on the petition from trade 
associations, consumer advocacy groups, businesses operating in the 
meat, poultry, and cultured food product markets, and consumers. Most 
comments opposed the petition overall; however, nearly all generally 
agreed that cultured meat and beef should be labeled in a manner that 
indicates how it was produced and differentiates it from slaughtered 
meat products.
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    \9\ Public comments on Petition 18-01 are available at https://www.regulations.gov/document/FSIS-2018-0016-0001/comment.
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    Several commenters, both for and against the petition, discussed 
the nature and source of cultured meat to support their arguments. 
Generally, commenters in support of the petition argued that cultured 
meat will not have the same characteristics as slaughtered meat or beef 
and, thus, should not be marketed as such. Commenters opposed to the 
petition, however, noted that cultured meat is derived from the same 
species as slaughtered meat and beef and can be produced with 
substantially similar characteristics as such products. Many commenters 
opposed to the petition also argued that the terms ``meat'' and 
``beef'' were necessary to inform consumers of the texture, shape, and 
function of certain cultured meat products.
    Commenters in support of the petition typically favored the 
creation of a standard of identity to differentiate slaughtered meat 
and beef from cultured products. Some livestock industry organizations 
that opposed the petition overall, also supported the creation of a 
standard of identity for cultured meat products. However, most opposed 
to the petition argued that standards of identity are not warranted, 
based on their assertions that cultured products, like slaughtered 
products, fall within the statutory and regulatory definitions of 
``meat'' or ``meat food product'' under the FMIA.
    Finally, some commenters expressed concern that the petition, if 
granted, would hamper innovation and, thereby, hurt the meat industry. 
A few others opposed the petition contending that the regulation of 
cultured meat labeling would violate the First Amendment.

E. Public Meeting on Animal Cell Culture Technology

    FSIS and FDA held a joint public meeting in October 2018 to discuss 
the potential hazards, oversight considerations, and labeling of 
cultured food products derived from livestock and poultry tissue (83 FR 
46476). The aforementioned USCA petition was also a topic of 
discussion. Transcripts of the meeting are available on the FSIS 
website.\10\
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    \10\ USDA and FDA Joint Public Meeting on the Use of Cell 
Culture Technology to Develop Products Derived from Livestock and 
Poultry, October 23-24, 2018, available at https://www.fsis.usda.gov/news-events/events-meetings/usda-and-fda-joint-public-meeting-use-cell-culture-technology-develop.
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    FSIS received approximately 315 comments on the joint public 
meeting, many of which were concerned with the labeling of cultured 
meat and poultry products. Comments expressed divergent views on 
whether cultured meat products should be labeled ``meat.'' Many felt 
the term would be misleading, arguing that cultured products are not 
produced in the same manner as, nor share substantially similar 
characteristics with, traditional meat. Some, however, felt it would be 
misleading not to refer to cultured products as ``meat,'' arguing that 
such products are derived from the same amenable livestock and can be 
produced to have the same characteristics as slaughtered meat products.
    Many on both sides of the issue agreed that the product name and 
other information on cultured meat and poultry product labels should 
indicate they were made using animal cell culture technology. Some also 
asked FSIS to establish standards of identity for cultured products. A 
few commenters, however, opposed such requirements, reasoning that 
animal cell culture technology does not alter the basic characteristics 
of the foods and that a standard of identity or other new labeling 
rules would stifle innovation in the cultured foods industry. A few 
comments were also concerned that new labeling requirements would 
unnecessarily put cultured products at a competitive disadvantage to 
slaughtered products.
    Commenters were also concerned with the regulation of special 
statements and claims on cell cultured products labels. Many comments 
asked FSIS to subject such claims to the same prior label approval 
process and oversight as slaughtered products. Others asked FSIS to 
establish specific guidance for such claims to ensure they are truthful 
and supported by sound science. A few advocated that animal cell 
culture technology companies be allowed to make special statements and 
claims about the environmental, food safety, and other benefits of 
their products, so long as they provide evidence to support such 
assertions.

F. Harvard Law School Animal Law & Policy Clinic Petition

    FSIS also has received a petition from the Harvard Law School 
Animal Law & Policy Clinic dated June 9, 2020, concerning the labeling 
of products made using animal cell culture technology.\11\ The petition 
requests that FSIS adopt a labeling approach for cultured meat and 
poultry products that respects First Amendment commercial speech 
protections. The petition specifically requests that FSIS establish a 
labeling approach that does not require new standards of identity and 
does not ban the use of common or usual meat or poultry terms or other 
product terms specified in regulatory standards of identity. The 
petition asserts that FSIS should wait until the Agency has a better 
understanding of the compositional and safety characteristics of 
finished products made using animal cell culture technology, and until 
it has had the opportunity to review proposed labels, before 
establishing speech restrictions that could raise constitutional

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questions. To date, FSIS received one comment from a non-profit 
organization, conveying broad support for the petition.
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    \11\ Petition 20-03 Submitted by Harvard Law School Animal Law & 
Policy Clinic, June 9, 2020, available at https://www.fsis.usda.gov/policy/petitions/.
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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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    \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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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 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.'')
    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 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'')?
    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 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.
    5. 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.
    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. 607(c) and 
457(b)) 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 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 sub-listing, 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

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Innovation) trade association); (4) the expected average annual volume 
per company, broken down by species or product type; (5) the expected 
number of labels per company, broken down by species or product type; 
(6) company size by expected revenue and number of employees; (7) data 
on the consumer benefits from labels that clearly identify or 
differentiate cultured meat and poultry products (e.g., saved research 
costs); and (8) information on naming conventions that would discourage 
consumer purchases or producer innovations and the associated economic 
impact. FSIS also seeks consumer research related to labeling 
nomenclature for products made using animal cell culture technology.
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    \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 15(4): e0231176(2020) Accessed on June 22, 2021: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0231176.
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IV. Label Evaluation Prior to Rulemaking

    Should any establishment wish to distribute a cultured meat or 
poultry product in commerce prior to related labeling rulemaking being 
completed, the establishment would need to submit the product label to 
FSIS for review. To learn about the process for submitting labels to 
FSIS, please see the ``Labeling and Label Approval'' web page.\15\ As 
discussed above, labels for cultured product are not eligible for 
generic approval at this time because neither industry nor consumers 
have experience with cultured products or their labels. Therefore, FSIS 
will need to review and approve cultured meat and poultry product 
labels before they are used in commerce to ensure they are not false or 
misleading. During label review, FSIS will ensure the labels clearly 
differentiate cell cultured product from slaughtered meat and poultry 
products and will ensure the labels bear all mandatory features 
required by the regulations for meat and poultry products. 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.
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    \15\ FSIS Labeling and Label Approval web page, https://www.fsis.usda.gov/inspection/compliance-guidance/labeling.
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V. USDA Non-Discrimination Statement

    In accordance with Federal civil rights law and U.S. Department of 
Agriculture (USDA) civil rights regulations and policies, the USDA, its 
Agencies, offices, and employees, and institutions participating in or 
administering USDA programs are prohibited from discriminating based on 
race, color, national origin, religion, sex, gender identity (including 
gender expression), sexual orientation, disability, age, marital 
status, family/parental status, income derived from a public assistance 
program, political beliefs, or reprisal or retaliation for prior civil 
rights activity, in any program or activity conducted or funded by USDA 
(not all bases apply to all programs). Remedies and complaint filing 
deadlines vary by program or incident.
    Persons with disabilities who require alternative means of 
communication for program information (e.g., Braille, large print, 
audiotape, American Sign Language, etc.) should contact the responsible 
Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or 
contact USDA through the Federal Relay Service at (800) 877-8339. 
Additionally, program information may be made available in languages 
other than English.
    To file a program discrimination complaint, complete the USDA 
Program Discrimination Complaint Form, AD-3027, found online at https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint and 
at any USDA office or write a letter addressed to USDA and provide in 
the letter all of the information requested in the form. To request a 
copy of the complaint form, call (866) 632-9992. Submit your completed 
form or letter to USDA by: (1) Mail: U.S. Department of Agriculture, 
Office of the Assistant Secretary for Civil Rights, 1400 Independence 
Avenue SW, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3) 
email: <a href="/cdn-cgi/l/email-protection#c4b4b6aba3b6a5a9eaadaab0a5afa184b1b7a0a5eaa3abb2"><span class="__cf_email__" data-cfemail="d4a4a6bbb3a6b5b9fabdbaa0b5bfb194a1a7b0b5fab3bba2">[email protected]</span></a>.
    USDA is an equal opportunity provider, employer, and lender.

VI. Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication online through the FSIS web page located at: 
https://www.fsis.usda.gov/federal-register.
    FSIS also will announce and provide a link to it through the FSIS 
Constituent Update, which is used to provide information regarding FSIS 
policies, procedures, regulations, Federal Register notices, FSIS 
public meetings, and other types of information that could affect or 
would be of interest to our constituents and stakeholders. The 
Constituent Update is available on the FSIS web page. Through the web 
page, FSIS is able to provide information to a much broader, more 
diverse audience. In addition, FSIS offers an email subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at https://www.fsis.usda.gov/subscribe. Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves and have the option to password protect 
their accounts.

Paul Kiecker,
Administrator.
[FR Doc. 2021-19057 Filed 9-2-21; 8:45 am]
BILLING CODE 3410-DM-P


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