Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Proposed Rules 49491 

In appropriate circumstances, when 

compliance would not appear to 

interfere with or adversely affect the law 

enforcement purposes of this system 

and the overall law enforcement 

process, the applicable exemptions may 

be waived on a case-by-case basis. 

A system of records notice for DHS/ 

OIDO–001 Office of the Immigration 

Detention Ombudsman System of 

Records is also published in this issue 

of the Federal Register. 

List of Subjects in 6 CFR Part 5 

Freedom of information; Privacy. 

For the reasons stated in the 

preamble, DHS proposes to amend 

chapter I of title 6, Code of Federal 

Regulations, as follows: 

PART 5—DISCLOSURE OF RECORDS 

AND INFORMATION 

■ 1. The authority citation for part 5 

continues to read as follows: 

Authority: 6 U.S.C. 101 et seq.; Pub. L. 

107–296, 116 Stat. 2135; 5 U.S.C. 301. 

Subpart A also issued under 5 U.S.C. 552. 

Subpart B also issued under 5 U.S.C. 552a. 

■ 2. In appendix C to part 5, add 

paragraph 86 to read as follows: 

Appendix C to Part 5—DHS Systems of 

Records Exempt From the Privacy Act 

* * * * * 

86. The DHS/OIDO–001 Office of the 

Immigration Detention Ombudsman System 

of Records consists of electronic and paper 

records and will be used by DHS and its 

components. The DHS/OIDO–001 Office of 

the Immigration Detention Ombudsman 

System of Records is a repository of 

information held by DHS in connection with 

its several and varied missions and functions, 

including, but not limited to the enforcement 

of civil and criminal laws, and investigations, 

inquiries, and proceedings there under. The 

DHS/OIDO–001 Office of the Immigration 

Detention Ombudsman System of Records 

contains information that is collected by, on 

behalf of, in support of, or in cooperation 

with DHS and its components and may 

contain personally identifiable information 

collected by other federal, state, local, tribal, 

foreign, or international government 

agencies. 

The Secretary of Homeland Security, 

pursuant to 5 U.S.C. 552a(k)(2) and (k)(5), has 

exempted this system from the following 

provisions of the Privacy Act: 5 U.S.C. 

552a(c)(3); (d); (e)(1), (e)(4)(G), (e)(4)(H), 

(e)(4)(I); and (f). Where a record received 

from another system has been exempted in 

that source system under 5 U.S.C. 552a(j)(2), 

(k)(2), or (k)(5), DHS will claim the same 

exemptions for those records that are claimed 

for the original primary systems of records 

from which they originated and claims any 

additional exemptions set forth here. 

Exemptions from these particular 

subsections are justified, on a case-by-case 

basis to be determined at the time a request 

is made, for the following reasons: 

(a) From subsection (c)(3) (Accounting for 

Disclosures) because release of the 

accounting of disclosures could alert the 

subject of an investigation of an actual or 

potential criminal, civil, or regulatory 

violation to the existence of that investigation 

and reveal investigative interest on the part 

of DHS as well as the recipient agency. 

Disclosure of the accounting would therefore 

present a serious impediment to law 

enforcement efforts and efforts to preserve 

national security. Disclosure of the 

accounting would also permit the individual 

who is the subject of a record to impede the 

investigation, to tamper with witnesses or 

evidence, and to avoid detection or 

apprehension, which would undermine the 

entire investigative process. When an 

investigation has been completed, 

information on disclosures made may 

continue to be exempted if the fact that an 

investigation occurred remains sensitive after 

completion. 

(b) From subsection (d) (Access and 

Amendment to Records) because access to 

the records contained in this system of 

records could inform the subject of an 

investigation of an actual or potential 

criminal, civil, or regulatory violation to the 

existence of that investigation and reveal 

investigative interest on the part of DHS or 

another agency. Access to the records could 

permit the individual who is the subject of 

a record to impede the investigation, to 

tamper with witnesses or evidence, and to 

avoid detection or apprehension. 

Amendment of the records could interfere 

with ongoing investigations and law 

enforcement activities. Further, permitting 

amendment to counterintelligence records 

after an investigation has been completed 

would impose an unmanageable 

administrative burden. In addition, 

permitting access and amendment to such 

information could disclose security-sensitive 

information that could be detrimental to 

homeland security. 

(c) From subsection (e)(1) (Relevancy and 

Necessity of Information) because in the 

course of investigations into potential 

violations of federal law, the accuracy of 

information obtained or introduced 

occasionally may be unclear, or the 

information may not be strictly relevant or 

necessary to a specific investigation. In the 

interests of effective law enforcement, it is 

appropriate to retain all information that may 

aid in establishing patterns of unlawful 

activity. 

(d) From subsections (e)(4)(G), (e)(4)(H), 

and (e)(4)(I) (Agency Requirements) and (f) 

(Agency Rules), because portions of this 

system are exempt from the individual access 

provisions of subsection (d) for the reasons 

noted above, and therefore DHS is not 

required to establish requirements, rules, or 

procedures with respect to such access. 

Providing notice to individuals with respect 

to existence of records pertaining to them in 

the system of records or otherwise setting up 

procedures pursuant to which individuals 

may access and view records pertaining to 

themselves in the system would undermine 

investigative efforts and reveal the identities 

of witnesses, and potential witnesses, and 

confidential informants. 

Lynn Parker Dupree, 

Chief Privacy Officer, U.S. Department of 

Homeland Security. 

[FR Doc. 2021–18797 Filed 9–2–21; 8:45 am] 

BILLING CODE 9112–AS–P 

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. 

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. 


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49492 Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Proposed Rules 

1This ANPR refers to all meat or poultry products 

not produced using animal cell culture technology 

as ‘‘slaughtered’’ meat and poultry products. 

2There 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. 

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. 

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). 

FSIS must review and approve all 

other labels before they are used on 

products intended for distribution in 


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Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Proposed Rules 49493 

3Other 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)). 

4On 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). 

5Specified 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)). 

6Formal 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. 

7FDA also has jurisdiction over products with 

3% or less raw meat or less than 2% cooked meat 

or poultry meat. 

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. 

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)). 

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. 

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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49494 Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Proposed Rules 

8Petition 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-traditionalsources. 

9Public comments on Petition 18–01 are available 

at https://www.regulations.gov/document/FSIS2018-0016-0001/comment. 

10USDA 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/newsevents/events-meetings/usda-and-fda-joint-publicmeeting-use-cell-culture-technology-develop. 

11Petition 20–03 Submitted by Harvard Law 

School Animal Law & Policy Clinic, June 9, 2020, 

available at https://www.fsis.usda.gov/policy/ 

petitions/. 

(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. 

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.’’ 

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. 

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

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 


lotter on DSK11XQN23PROD with PROPOSALS1
Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Proposed Rules 49495 

12U.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. 

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. 

14Rolland 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. 

questions. To date, FSIS received one 

comment from a non-profit 

organization, conveying broad support 

for the petition. 

G. U.S. Government Accountability 

Office Report 

The U.S. Government Accountability 

Office (GAO) recently completed a 

review to, in part, understand how 

much information on the commercial 

production of cultured meat and poultry 

is available to federal regulators, 

including FSIS.12 It found that federal 

regulators lack specific information on 

the technology being used, eventual 

commercial production methods, and 

composition of the final products. FSIS 

hopes to receive such information in 

response to this ANPR, so that it can 

make informed decisions regarding the 

labeling of these products. 

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 sublisting, or elsewhere on the label? 

13. Should the presence of cultured animal 

cells in further processed products regulated 

by FSIS, such as a lasagna made with cell 

cultured beef cells as an ingredient, be 

qualified on the product label? If so, how 

should this be qualified? 

14. What label claims are likely to appear 

on FSIS-regulated products comprised of or 

containing cultured animal cells? Should 

FSIS develop new regulations or guidance on 

such claims to ensure they are neither false 

nor misleading? 

III. Request for Economic Data and 

Consumer Research 

Along with the above questions about 

the costs and benefits of labeling 

options for cell cultured meat and 

poultry, FSIS seeks economic data and 

consumer research to help increase its 

understanding of the animal cell culture 

technology industry and related issues 

regarding labeling and consumer 

perceptions of food made using this 

technology. FSIS is particularly 

interested in information regarding: (1) 

The impact of the labeling of cell 

cultured meat and poultry on 

consumers’ perception of and 

willingness to pay for cultured meat and 

poultry products; (2) the expected price 

per pound of cultured meat and poultry 

products; (for example, FSIS has 

reviewed recent studies that discuss 

consumer perception 13 and willingness 

to pay 14 for cultured meat products); (2) 

the expected price per pound of 

cultured meat and poultry products; (3) 

the number of domestic and the number 

of international animal cell culture 

technology companies estimated to 

enter the U.S. market (for example, FSIS 

is aware of eight domestic companies 

who belong to the Alliance for Meat, 

Poultry and Seafood Innovation (AMPS 


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49496 Federal Register / Vol. 86, No. 169 / Friday, September 3, 2021 / Proposed Rules 

15FSIS Labeling and Label Approval web page, 

https://www.fsis.usda.gov/inspection/complianceguidance/labeling. 

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. 

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. 

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-aprogram-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: program.intake@usda.gov. 

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 

FARM CREDIT ADMINISTRATION 

12 CFR Part 615 

RIN 3052–AD44 

Bank Liquidity Reserve 

AGENCY: Farm Credit Administration. 

ACTION: Advance notice of proposed 

rulemaking; extension of comment 

period. 

SUMMARY: The Farm Credit 

Administration (FCA or we) is 

extending the comment period on its 

Advance Notice of Proposed 

Rulemaking (ANPRM) that seeks 

comment from the public about whether 

and how FCA should revise its liquidity 

regulatory framework for Farm Credit 

System (System) banks. FCA is 

extending the comment period for an 

additional 60 days, until November 27, 

2021, so interested parties will have 

additional time to provide comments on 

the ANPRM. 

DATES: The comment period for the 

Advance Notice of Proposed 

Rulemaking on Bank Liquidity Reserves, 

published on June 30, 2021 (86 FR 

34645), is extended from September 28, 

2021, to November 27, 2021. 

ADDRESSES: For accuracy and efficiency 

reasons, please submit comments by 

email or through FCA’s website. We do 

not accept comments submitted by 

facsimiles (fax), as faxes are difficult for 

us to process and achieve compliance 

with section 508 of the Rehabilitation 

Act of 1973. Please do not submit your 

comment multiple times via different 

methods. You may submit comments by 

any of the following methods: 

• Email: Send us an email at regcomm@fca.gov. 

• FCA website: http://www.fca.gov. 

Click inside the ‘‘I want to . . .’’ field 

near the top of the page; select 

‘‘comment on a pending regulation’’ 

from the dropdown menu; and click 

‘‘Go.’’ This takes you to an electronic 

public comment form. 

• Mail: Kevin J. Kramp, Director, 

Office of Regulatory Policy, Farm Credit 


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