[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:
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.
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.
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: [email protected].
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