[Federal Register Volume 86, Number 180 (Tuesday, September 21, 2021)]
[Notices]
[Pages 52439-52441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20403]


=======================================================================
-----------------------------------------------------------------------

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 multi-component 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:
    <bullet> Product Name;
    <bullet> Handling statement (e.g., Keep Refrigerated), if product 
is perishable;
    <bullet> USDA legend and establishment number of the official 
establishment that packaged and labeled the meat or poultry component;
    <bullet> Name and address of the manufacturer, packer, or 
distributor;
    <bullet> Ingredients statement (if composed of more than one 
ingredient); and
    <bullet> 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/fsis-guidelines. 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-to-consumer platforms. Several 
trade associations requested that FSIS clarify which meat or poultry 
components

[[Page 52440]]

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-export-library. 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 animal-raising 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

[[Page 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-a-program-discrimination-complaint and 
at any USDA office or write a letter addressed to USDA and provide in 
the letter all of the information requested in the form. To request a 
copy of the complaint form, call (866) 632-9992. Submit your completed 
form or letter to USDA by: (1) Mail: U.S. Department of Agriculture, 
Office of the Assistant Secretary for Civil Rights, 1400 Independence 
Avenue SW, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3) 
email: <a href="/cdn-cgi/l/email-protection#b2c2c0ddd5c0d3df9cdbdcc6d3d9d7f2c7c1d6d39cd5ddc4"><span class="__cf_email__" data-cfemail="c2b2b0ada5b0a3afecabacb6a3a9a782b7b1a6a3eca5adb4">[email protected]</span></a>.
    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


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>