Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Notices 52439 

(Authority: Sec. 6, Pub. L. 113–189, 128 Stat. 

3288 (22 U.S.C. Ch. 32 2152h)) 

Dated: September 16, 2021. 

Lisa Schechtman, 

Senior Policy and Partnerships Advisor, 

Center for Water Security, Sanitation and 

Hygiene, Bureau for Resilience and Food 

Security, United States Agency for 

International Development. 

[FR Doc. 2021–20366 Filed 9–20–21; 8:45 am] 

BILLING CODE 6116–02–P 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

[Docket No. FSIS–2018–0041] 

Availability of Kit Product Labeling 

Guideline 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Notice of availability and 

response to comments. 

SUMMARY: In July 2019, the Food Safety 

and Inspection Service (FSIS) published 

and requested comment on a guideline 

for establishments producing multicomponent kit products that contain 

inspected and assembled meat or 

poultry components. FSIS is 

announcing updates to this guideline 

and responding to comments received 

on the guideline. FSIS intends for this 

guideline to help establishments and 

other food handling facilities producing 

a multi-component food kit determine 

whether the kit product needs to be 

prepared under FSIS inspection and 

how to label a kit product that contains 

fully labeled meat or poultry 

components. The guideline represents 

current FSIS thinking, and FSIS will 

update it as necessary to reflect 

comments received and any additional 

information that becomes available. 

ADDRESSES: A downloadable version of 

the kit guideline is available to view and 

print at: https://www.fsis.usda.gov/ 

policy/fsis-guidelines. No hard copies of 

the kit guideline have been published. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Edelstein, Assistant 

Administrator, Office of Policy and 

Program Development by telephone at 

(202) 205–0425. 

SUPPLEMENTARY INFORMATION: 

Background 

FSIS administers a regulatory program 

under the Federal Meat Inspection Act 

(FMIA) (21 U.S.C. 601 et seq.), the 

Poultry Products Inspection Act (PPIA) 

(21 U.S.C. 451 et seq.), and the Egg 

Products Inspection Act (EPIA) (21 

U.S.C. 1031 et seq.) to, in part, ensure 

that that the labeling of meat, poultry 

and egg products is truthful and not 

misleading. Mandatory labeling 

requirements for meat and poultry 

products are prescribed in Title 9 of the 

Code of Federal Regulations (CFR) 

section 317.2 and part 381 subpart N. 

On July 9, 2019, FSIS announced the 

availability of and requested comment 

on the Food Safety and Inspection 

Service Guideline on Kit Labeling (84 FR 

32705). FSIS developed the guideline 

for establishments and other food 

handling facilities to provide 

information on the labeling and 

inspection of multi-component food kit 

products that contain an inspected and 

assembled meat or poultry component. 

There are many varieties of food kit 

products that contain meat or poultry 

products, including, but not limited to: 

Wraps, pizza, stew, salads, fajitas, 

stroganoff, and stir-fry skillet meals. 

These items are commonly sold as fully 

cooked, but some may require cooking. 

Generally, the meat and poultry 

components are separately wrapped and 

already inspected and fully labeled 

before assembly with various food 

components in the same packaging. 

As announced in the July 2019 

guideline, FSIS determined that the act 

of assembling a food kit product whose 

label refers to meat or poultry in its 

name does not need to be done under 

FSIS inspection, provided that the meat 

or poultry component has already be 

inspected, packaged, and labeled and as 

long as the following conditions are 

met: 

1. The meat or poultry component is 

prepared and separately packaged under 

FSIS inspection and labeled with all 

required features, including: 

• Product Name; 

• Handling statement (e.g., Keep 

Refrigerated), if product is perishable; 

• USDA legend and establishment 

number of the official establishment that 

packaged and labeled the meat or 

poultry component; 

• Name and address of the 

manufacturer, packer, or distributor; 

• Ingredients statement (if composed 

of more than one ingredient); and 

• Safe handling instructions if the 

meat or poultry components is not 

ready-to-eat; 

2. The outer kit label clearly identifies 

all the individual components in the kit; 

and 

3. The outer kit label clearly identifies 

the product as a single unit or ‘‘kit’’ 

such as ‘‘Chicken Barbecue Dinner Kit’’ 

and ‘‘Beef Lasagna Meal.’’ 

Although FSIS will no longer conduct 

mandatory inspection of the assembly of 

the kit product, the meat or poultry 

component of the kit remains under 

FSIS’ jurisdiction and, as such, is 

required to meet all applicable FSIS 

labeling requirements. 

The revised guideline is posted at: 

https://www.fsis.usda.gov/policy/fsisguidelines. Although comments will no 

longer be accepted through https://

www.regulations.gov/ on this guideline, 

FSIS will update this document as 

necessary if new information becomes 

available. 

Comments and FSIS Responses 

FSIS received 15 comments on the kit 

guideline. Most comments were 

submitted by firms that prepare kits and 

trade associations that represent the 

meat and retail industries. In addition, 

FSIS received comments from an animal 

welfare organization, a firm that exports 

kit products from the United States, an 

FSIS employee, and several individuals. 

The following is a summary of the 

comments and FSIS’ responses: 

Kit Definition 

Comment: One consumer requested 

that FSIS provide a clearer definition of 

a kit and clarify whether Agency policy 

distinguishes between a kit and a meal 

kit. One firm that prepares kits similarly 

requested a clearer definition of a kit 

and asked for additional guidance on 

the distinction between a single unit 

and a kit. 

Response: As stated in the guideline, 

a kit product consists of individually 

packaged meat or poultry components 

and other food components sold 

together as a single unit. FSIS policy 

does not distinguish between the terms 

‘‘kit’’, ‘‘meal kit’’, or ‘‘single unit.’’ 

Although the word ‘‘kit’’ is not required 

on the label, all labeling should clearly 

indicate that the product consists of 

individual components. Because this 

information is already stated in the 

guideline, FSIS did not make any 

changes to it in response to these 

comments. 

Retail Exemption 

Comment: Several commenters, 

including firms that prepare kit 

products and trade associations 

representing the meat and retail food 

industries, requested that FSIS revise 

the guideline to provide clarifying or 

additional information about eligibility 

for the retail exemption from FSIS 

inspection. One firm requested 

explanation of how the retail exemption 

applies to kits assembled and sold by 

retail grocery stores, prepared kits sold 

at retail, and kits sold through online 

marketplaces and other direct-toconsumer platforms. Several trade 

associations requested that FSIS clarify 

which meat or poultry components 


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52440 Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Notices 

produced under the retail exemption 

need not bear all required features for 

labeling. One firm stated that such 

clarification would avoid manufacturer 

confusion about whether meal kits that 

include a recipe card would be eligible 

for the retail exemption. 

Response: The guideline does not 

apply to facilities preparing kits under 

the retail exemption from FSIS 

inspection (9 CFR 303.1(d) and 

381.10(a)(1)) because these facilities 

were not previously required to 

assemble kits under FSIS inspection. 

The retail exemption remains 

unchanged by the guideline. Kits 

prepared under the retail exemption 

may only be sold directly to the end 

consumer and cannot be sold for resale. 

FSIS has updated the guideline to 

clarify that the scope of the document 

does not include products produced 

under the retail exemption. The original 

version and updated version of the 

guideline explain that FSIS labeling 

regulations, other than the requirement 

of the official inspection legend, apply 

to kits that are assembled under the 

retail exemption (9 CFR 303.1(f), 

381.10(d)(4)). 

Bulk Labeling 

Comment: One firm that prepares kits 

requested clarification on whether FSIS 

inspection and label approval 

requirements apply to firms that receive 

and further process bulk product as part 

of final kit assembly, including 

portioning and packaging the meat 

component. Another firm that prepares 

kits using bulk-packed FSIS-inspected 

products asked whether the firm may 

make copies of the label on the bulk 

container and apply them to the product 

components that have been separated 

and rewrapped. 

Response: FSIS has updated the 

guideline to clarify that Agency 

guidance on the preparation of kit 

products without FSIS inspection does 

not apply when the meat or poultry 

component is processed, including 

portioned or packaged, by the firm 

assembling the kit. Such processing 

activities would require FSIS inspection 

if the production does not qualify for 

the retail exemption. Further, the 

resulting assembled kit product would 

require label approval by FSIS if the 

outer kit label met any of the conditions 

for required label approval under the 

regulations at 9 CFR 412.1. A firm 

portioning and repackaging bulk-packed 

products typically would not be 

permitted to make a copy of the original 

label since that label would likely bear 

the original establishment’s USDA 

legend, company name, and a net 

weight. 

Component Standard of Identity 

Comment: One consumer requested 

clarification on whether, if the finished 

product of the meat or poultry 

component of a kit is labeled as a 

product that has a standard of identity, 

must the fully assembled kit label meet 

that standardized product name. 

Response: FSIS updated the guideline 

to clarify that if a kit is labeled as a 

product with a standard of identity as 

defined under the regulations in 9 CFR 

part 319 or 381 subpart P, the 

components, once assembled, must 

meet the applicable standard of identity. 

For example, a ‘‘Beef Chili Kit’’ must 

contain 40 percent beef computed based 

on the weight of the fresh meat as 

described in 9 CFR 319.300. 

Shipping Container Labeling 

Comment: A USDA employee asked 

whether a shipping container 

comprising one or multiple kit products 

that were assembled at an official 

establishment without FSIS inspection 

would need to bear a USDA legend. 

Response: The regulatory requirement 

that the shipping container bear a USDA 

legend (9 CFR 316.13 and 381.27) only 

applies to products that have been 

inspected and passed. FSIS updated the 

guideline to clarify that when a kit is 

assembled in an official establishment 

without FSIS inspection, the shipping 

container into which the kit is placed 

may not bear a USDA legend. In such 

case, the mark of inspection will be 

displayed on the label and packaging of 

the meat or poultry component included 

in the kit. 

Outer Package Labeling 

Comment: Comments from several 

trade associations, firms that prepare kit 

products, individuals, and one USDA 

employee asked FSIS to clarify what 

language should be used on the kit label 

to describe the product as a single unit 

of individual components. These 

commenters also asked where the 

description of the individual 

components should be displayed on the 

outer label. 

Response: FSIS has updated the 

guideline to clarify that the 

requirements for the language on the 

outer kit label that identify the product 

as a kit are flexible. The outer label for 

the kit should identify all the individual 

components in the kit, as well as 

identify the product as a single unit. 

The use of the word ‘‘kit’’ on the outer 

label is not required, nor is a specific 

location on the outer label for the 

identification of the individual 

components. For example, the outer 

label could display the product name 

‘‘Chicken Barbecue Dinner Kit’’ or ‘‘Beef 

Lasagna Meal.’’ 

Immediate Package Labeling 

Comment: One consumer asked 

whether FSIS would require safe 

handling instructions on the immediate 

package of a not ready to eat (NRTE) 

meat or poultry component in a kit. 

Response: As stated in the guideline, 

if the meat or poultry component of a 

kit product is NRTE, the immediate 

package must include safe handling 

instructions in order to meet the 

regulatory requirements for kit assembly 

without FSIS inspection. 

Export Labeling 

Comment: One firm that exports kit 

products to Canada asked which 

package components need to include 

bilingual labels. 

Response: FSIS does not require 

bilingual labels; however, Canada does 

have such labeling requirements (i.e., 

French and English). More information 

about Canada’s requirements can be 

found on the Import and Export Library 

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

inspection/import-export/import-exportlibrary. FSIS inspectors verify and 

certify that products intended to be 

exported to a foreign country meet the 

foreign country’s requirements. 

Labeling Claims and Declarations 

Comment: An animal welfare 

organization requested that FSIS require 

pre-market label approval for animalraising claims on the exterior packaging 

of kit products. 

Response: As a kit meeting the criteria 

as described in the guideline may be 

assembled without FSIS inspection and, 

as such, the outer label does not bear a 

USDA legend, the outer label is not 

subject to label approval requirements 

under the regulations at 9 CFR 412.1. 

Outer kit labels for products assembled 

without FSIS inspection under the 

conditions described in the guideline 

are required to comply with FSIS 

labeling requirements. 

Comment: One firm that prepares kits 

requested that FSIS require allergen 

declarations to be displayed on the 

outer packaging and to prohibit 

ingredient statements on the meat or 

poultry component. The commenter 

stated that such requirements would 

reduce consumer confusion by 

identifying all allergens and other 

ingredients in a central location on the 

retail package. 

Response: If the only component 

within the kit that includes an 

ingredients statement is the meat or 

poultry component, that should not 

cause any confusion. FSIS does not 


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Federal Register / Vol. 86, No. 180 / Tuesday, September 21, 2021 / Notices 52441 

think that consumers will assume other 

unlabeled components, such as soy 

sauce or pasta, do not contain allergens. 

Both the outer kit label and the meat or 

poultry component must be fully 

labeled in compliance with FSIS 

labeling regulations. Therefore, the 

outer kit label will bear a complete 

ingredients statement that declares all 

ingredients in each component within 

the kit. These labeling requirements 

were already explained in the previous 

version of the guideline; therefore, FSIS 

did not make any changes in response 

to this comment. 

Comment: One individual asked FSIS 

to explain how the nutrition facts 

declaration should be displayed on a 

kit. 

Response: A kit label bearing 

nutrition facts may present this 

information 1. centrally, based on the 

prepared, assembled product; 2. with 

separate panels for each component as 

packaged; or 3. as one panel with 

multiple columns for each component 

as packaged. The nutrition labeling 

requirements of 9 CFR 317.309 and 

381.409 remain unchanged by this 

guideline. FSIS did not make any 

changes to the guideline based on this 

comment. Based on FSIS 

communications with these facilities, 

they understand nutrition labeling 

requirements. 

Labeling Verification 

Comment: One firm that prepares kits 

stated that the Agency should provide 

clear communication to FSIS inspectors 

to ensure the consistent application of 

kit labeling policies. 

Response: FSIS will issue a directive 

to provide instructions to inspection 

program personal for conducting 

verification activities for kit products to 

ensure compliance with FSIS 

regulations. 

Mandatory and Voluntary FSIS 

Inspection 

Comment: An FSIS employee 

requested that FSIS clarify whether a kit 

may be assembled under voluntary FSIS 

inspection and, therefore, bear a USDA 

inspection legend. 

Response: FSIS clarified in the 

guideline that the assembly of a kit 

product as described in this guideline is 

eligible for voluntary inspection as a 

food inspection service under 9 CFR 

350.3(c). FSIS also announced that, 

going forward, it will no longer conduct 

mandatory inspection services for such 

kits, as the Agency determined that 

providing inspection for these products 

as a voluntary food inspection service is 

the best use of Agency resources. After 

publication of this notice, FSIS will 

provide instructions for firms currently 

receiving mandatory inspection for such 

products regarding the procedures and 

timelines for withdrawing mandatory 

inspection and the option to seek 

voluntary inspection. 

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. 

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 make copies of this publication 

available 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. 2021–20403 Filed 9–20–21; 8:45 am] 

BILLING CODE 3410–DM–P 

DEPARTMENT OF COMMERCE 

Census Bureau 

Agency Information Collection 

Activities; Submission to the Office of 

Management and Budget (OMB) for 

Review and Approval; Comment 

Request; Generic Clearance for 

Emergency Economic Information 

Collections 

The Department of Commerce will 

submit the following information 

collection request to the Office of 

Management and Budget (OMB) for 

review and clearance in accordance 

with the Paperwork Reduction Act of 

1995, on or after the date of publication 

of this notice. We invite the general 

public and other Federal agencies to 

comment on proposed, and continuing 

information collections, which helps us 

assess the impact of our information 

collection requirements and minimize 

the public’s reporting burden. Public 

comments were previously requested 

via the Federal Register on February 8, 

2021 during a 60-day comment period. 

This notice allows for an additional 30 

days for public comments. 

Agency: U.S. Census Bureau, 

Department of Commerce. 

Title: Generic Clearance for 

Emergency Economic Information 

Collections. 

OMB Control Number: 0607–XXXX. 


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