Notice2021-20403
Availability of Kit Product Labeling Guideline
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 21, 2021
Issuing agencies
Agriculture DepartmentFood Safety and Inspection Service
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 180 (Tuesday, September 21, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 180 (Tuesday, September 21, 2021)]
[Notices]
[Pages 52439-52441]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://www.fsis.usda.gov/policy/fsis-guidelines">https://www.fsis.usda.gov/policy/fsis-guidelines</a>. 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: <a href="https://www.fsis.usda.gov/policy/fsis-guidelines">https://www.fsis.usda.gov/policy/fsis-guidelines</a>. Although comments will no longer be accepted
through <a href="https://www.regulations.gov/">https://www.regulations.gov/</a> 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: <a href="https://www.fsis.usda.gov/inspection/import-export/import-export-library">https://www.fsis.usda.gov/inspection/import-export/import-export-library</a>. 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 <a href="https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint">https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint</a> 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:
<a href="https://www.fsis.usda.gov/federal-register">https://www.fsis.usda.gov/federal-register</a>. 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: <a href="https://www.fsis.usda.gov/subscribe">https://www.fsis.usda.gov/subscribe</a>. 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>Indexed from Federal Register on September 21, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.