[Federal Register Volume 89, Number 101 (Thursday, May 23, 2024)]
[Notices]
[Pages 45626-45629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11310]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2020-0030]


Availability of FSIS Guideline To Assist With the Donation of 
Eligible Meat, Poultry and Egg Products to Non-Profit Organizations

AGENCY: Food Safety and Inspection Service (FSIS), U.S. Department of 
Agriculture (USDA).

ACTION: Notice of availability and response to comments.

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SUMMARY: On December 21, 2020, FSIS published and requested comments on 
a guideline addressing the donation of meat and poultry products from 
official establishments to non-profit organizations. FSIS is announcing 
updates to this guideline and responding to comments received on the 
previous version of the guideline.

ADDRESSES: A downloadable version of the guideline is available to view 
and print at https://www.fsis.usda.gov/policy/fsis-guidelines.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant 
Administrator, Office of Policy and Program Development by telephone at 
(202) 205-0495.

SUPPLEMENTARY INFORMATION: 

Background

    On December 21, 2020, FSIS announced in the Federal Register the 
availability of the FSIS Guideline to Assist with the Donation of 
Eligible Meat and Poultry Products to Non-Profit Organizations (85 FR 
83029). FSIS published the guideline to address food donation questions 
from meat and poultry establishments and non-profit organizations. The 
guideline explained inspection, labeling, shipping requirements, and 
exemptions. FSIS requested comments on the guideline.
    After review and consideration of all comments, FSIS has made 
changes to and clarified certain aspects of the

[[Page 45627]]

guideline. For example, FSIS revised the donation flowchart in the 
guideline to improve readability. The other revisions to the guideline 
are summarized below and are discussed in more detail in FSIS' 
responses to comments. The revised guideline is available at the FSIS 
guidance web page at https://www.fsis.usda.gov/policy/fsis-guidelines. 
Although comments on this guideline will no longer be accepted through 
www.regulations.gov, FSIS will continue to update this document as 
necessary.
    Meat and poultry establishments can be a critical component of 
reducing food loss and waste. FSIS encourages establishments to donate 
meat and poultry products to non-profit organizations, when possible, 
to reduce food loss and waste.

Summary of Changes to the Guideline

     FSIS updated the ``Preface'' section to specify which 
products are covered under the guideline;
     FSIS added information on donating egg products to help 
establishments and non-profit organizations better understand the 
relevant statutes, regulations, and FSIS policies;
     FSIS added a section to the guideline that addresses 
limited liability protection for donors including information related 
to the Bill Emerson Good Samaritan Food Donation Act and the Food 
Donation Improvement Act;
     FSIS updated the text to reflect the updated and 
recommitted formal agreement between USDA, the U.S. Environmental 
Protection Agency, and the U.S. Food and Drug Administration (FDA);
     FSIS removed the ``Donation Recipients'' section to 
eliminate confusion;
     FSIS moved the ``State-Inspected Products,'' ``Expired 
Products,'' ``Incorrect Standards of Identity,'' and ``Statement of 
Limited Use/Distribution'' sections to under the ``Products Eligible 
for Donation'' heading to improve readability;
     FSIS ensured that all in-text citations are properly 
linked;
     FSIS revised the ``Guidance for Organizations Receiving 
Donated Products'' section of the guideline to alleviate confusion and 
improve readability;
     FSIS updated the donation flowchart to improve readability 
and include references to State inspected products;
     FSIS added a reference to FDA's final rule ``Sanitary 
Transportation of Human and Animal Food as an additional resource to 
assist stakeholders in keeping products safe during transport;'' \1\
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    \1\ See: https://www.govinfo.gov/content/pkg/FR-2016-04-06/pdf/2016-07330.pdf.
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     FSIS modified the ``Misbranded and Economically 
Adulterated Products'' section of the guideline to clarify labeling 
requirements for products with ingredients of public health concern; 
and
     FSIS revised the ``Misbranded and Economically Adulterated 
Products'' section of the guideline to remove language that could have 
been misinterpreted as FSIS creating new policy.

Comments and Responses

    FSIS received five comments on the guideline from two meat 
producers, two State governments, and an academic institution. The 
following is a summary of the comments and FSIS' responses.

General

    Comment: A State government recommended that FSIS add language to 
the guideline on proper cooking temperatures for raw meat and poultry 
products and cooking instructions for pre-packaged food. The commenter 
suggested that adding this information to the guideline would benefit 
donation recipients and reduce the risk of wasted resources.
    Response: FSIS did not add information about proper cooking 
temperatures to the food donation guideline because they are not 
relevant to the guideline. Information on proper cooking temperatures 
can be found in other guidance documents, such as the Safe Minimum 
Cooking Temperatures charts found at https://www.foodsafety.gov/food-safety-charts/safe-minimum-cooking-temperature.
    Comment: A meat producer, an academic institution, and a State 
government stated that FSIS should allow products produced under the 
custom exemptions to be donated. The academic institution stated that 
there are instances when products produced at custom processing or 
slaughter facilities are eligible for donation at the State and local 
level. The academic institution suggested that revising the exemptions 
table in the guideline would help avoid confusion and potential 
jurisdictional concerns and would promote donation practices that are 
currently allowed and encouraged under many State and local laws. The 
State government further noted that there is meat and poultry waste 
generated at custom processing establishments, and that there is an 
opportunity to allow for donation. A separate meat producer noted that 
there are other instances when uninspected meat is permissible for 
donation (i.e., hunter-harvested venison).
    Response: Custom slaughtered and processed meat and poultry 
products that are prepared from amenable species under the Federal Meat 
Inspection Act (FMIA) or Poultry Products Inspection Act (PPIA) are 
prohibited from being donated (21 U.S.C. 623(a) and 21 U.S.C. 
464(c)(1)(B)). Custom products are for the exclusive use of the owner 
of the livestock or poultry, members of the owner's household, 
nonpaying guests, or household employees. Additionally, specific 
exemptions under the Egg Products Inspection Act (EPIA) can be found in 
21 U.S.C. 1044.
    Meat products amenable to the FMIA include those derived from 
carcasses and parts of cattle, sheep, swine, goat, and fish of the 
order Siluriformes. Poultry products amenable to the PPIA are derived 
from any domesticated bird (chickens, turkeys, ducks, geese, ratites, 
or squabs, also termed young pigeons from 1 to about 30 days of age). 
Egg products amenable to the EPIA are from the shell eggs of the 
domesticated chicken, turkey, duck, goose, or guinea.
    Nonamenable products (e.g., deer, elk, and bison) that fall under 
the jurisdiction of other regulatory authorities (i.e., FDA, State, or 
local governments) may have different policies related to donating 
products. FSIS recommends consulting with these regulatory authorities 
for further clarification on donating those products. FSIS did not 
revise the exemptions table in the guideline to incorporate nonamenable 
products. However, FSIS updated the ``Preface'' section of the 
guideline to specify which products are covered under the guideline and 
FSIS jurisdiction.
    Comment: A State government and an academic institution suggested 
that FSIS include information in the guideline on the Bill Emerson Good 
Samaritan Act (42 U.S.C. 1791) and liability protections for food 
donors. The State government stated that liability protection is 
potential donors' primary concern.
    Response: FSIS agrees and has added a section to the guideline that 
addresses limited liability protection for donors. However, it is 
important to reiterate that donations of apparently wholesome meat and 
poultry products by qualified direct donors must be made in compliance 
with FSIS regulations.
    Comment: A State government noted that the guideline includes an 
exclusion from temporary label approval and relabeling, provided that 
certain bill of lading statements are provided. The

[[Page 45628]]

commenter argued that this exclusion could be exploited by unscrupulous 
firms seeking to move products, originally diverted into the animal 
food chain, back to the human food chain. The commenter suggested that 
FSIS reconsider this exclusion.
    Response: FSIS has no reason to believe that establishments are 
exploiting its streamlined donation process, which allows 
establishments to donate wholesome products with minor labeling issues 
without temporary label approval and relabeling, provided that certain 
information is included on bill of lading statements. The FSIS Office 
of Investigation, Enforcement and Audit conducts surveillance and 
investigation of regulated in-commerce meat, poultry, and egg products 
facilities to prevent situations like the commenter suggested.
    Comment: A State government expressed concern that the guideline 
uses language that may conflict with State meat and poultry inspection 
(MPI) and local regulations. The State government noted that the term 
``Not for Sale'' conflicts with their State's use of the same term, and 
that this may lead to confusion. The commenter also noted that their 
State does not permit inspection-exempt poultry processed by the 
producer (fewer than 1,000 birds) and labeled as ``Not for Sale'' to be 
sold at retail or donated to charity, and that donated product in their 
State must be inspected and passed.
    Response: FSIS does not believe that it is necessary to revise the 
guideline to avoid potential conflicting terminology with State MPI 
regulations. The terminology used in the guideline has been used for 
many years, and potential conflicts with State MPI regulatory language 
have not been found to be a problem. Also, the table in the guideline 
referenced by the commenter explicitly states that it covers poultry 
products slaughtered and/or produced under an exemption from Federal 
Inspection. The guideline also states that donations must be made in 
compliance with applicable State and local laws.
    Comment: A State government questioned whether the retail exemption 
still applies when the non-profit organization is exempted by State law 
from being required to hold a retail food establishment license. The 
commenter suggested that the guideline could mention that States may 
have specific licensing requirements or exemptions applicable to the 
non-profit organization.
    Response: FSIS did not revise the guideline in response to the 
commenter's suggestion. The guideline already states that retailers are 
subject to the licensing requirements of State and local (i.e., county, 
city) authorities while producing products under the retail exemption 
from FSIS inspection.
    Comment: An academic institution and a State government recommended 
that FSIS clarify that the donation recipients mentioned in the 
guideline are not exclusive but illustrative. The academic institution 
suggested that producers and donation recipients will benefit from 
making this change to the guideline, because it will be clearer which 
donation recipients are eligible and will increase potential donations.
    Response: FSIS has removed the ``Donation Recipients'' section from 
the guideline to alleviate any potential confusion.

Formatting

    Comment: Two State governments recommended that FSIS add sections 
to the guideline highlighting any updates or changes to previous FSIS 
policies, explaining case studies, and defining key terms.
    Response: Consistent with other FSIS guidelines, this updated 
guideline contains a section summarizing changes from the previous 
version. FSIS does not believe that additional examples are needed in 
the guideline, so the Agency did not revise the guideline to include 
additional examples. If firms need further clarification on any 
information in the guideline in relation to their specific situation, 
FSIS recommends contacting the Office of Policy and Program Development 
through askFSIS, or by telephone at 1-800-233-3935. Lastly, all 
significant terminology in the guideline is defined throughout the 
document. Therefore, FSIS did not revise the guideline to add a 
specific section that defines key words.
    Comment: A State government recommended moving content about 
donating State-inspected products and donating ``expired'' products to 
earlier in the guideline with the other donation standards.
    Response: FSIS agrees and has moved the ``State-Inspected 
Products'' and ``Expired Products'' sections to under the ``Products 
Eligible for Donation'' section. FSIS believes that these changes will 
improve readability. FSIS also moved the ``Incorrect Standards of 
Identity'' and ``Statement of Limited Use/Distribution'' sections to 
under the ``Products Eligible for Donation'' to achieve the same 
objective.
    Comment: An academic institution commented on the ``Retail 
Exemption'' section under the ``Guidance for Organizations Receiving 
Donated Products.'' The academic institution argued that the retail 
exemption for non-profit organizations is already addressed in the 
``relabeling'' section.
    Response: FSIS agrees with the comment and has revised the 
``Guidance for Organizations Receiving Donated Products'' section of 
the guideline to alleviate confusion and improve readability.

Donation Flowchart

    Comment: A State government and an academic institution suggested 
that FSIS revise the donation flowchart in the guideline to improve 
readability and to indicate that certain State-inspected and passed 
products can also be eligible for donation.
    Response: FSIS has updated the flowchart to improve readability and 
to address the donation of meat and poultry products produced under 
State MPI or Cooperative Interstate Shipment inspection.

Shipping Donated Products

    Comment: A State government suggested that FSIS should consider 
expanding the ``Shipping Donated Products'' section of the guideline to 
include proper storage temperatures and times. The commenter argued 
that this will reduce the risk of products spoiling during transport.
    Response: FSIS added a reference to FDA's Sanitary Transportation 
of Human and Animal Food Final Rule \2\ in the updated guideline. The 
rule addresses the commenter's concerns about proper storage 
temperatures and times during transport.
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    \2\ See: https://www.govinfo.gov/content/pkg/FR-2016-04-06/pdf/2016-07330.pdf.
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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: 
http://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 
can 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

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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.

USDA Non-Discrimination Statement

    In accordance with Federal civil rights law and 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/forms/electronic-forms and at any USDA office or write a 
letter addressed to USDA and provide in the letter all of the 
information requested in the form. To request a copy of the complaint 
form, call (866) 632-9992.
    Submit your completed form or letter to USDA by:
    (1) Mail: U.S. Department of Agriculture, Office of the Assistant 
Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 
20250-9410;
    (2) Fax: (202) 690-7442; or
    (3) Email: [email protected].
    USDA is an equal opportunity provider, employer, and lender.

    Done at Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2024-11310 Filed 5-22-24; 8:45 am]
BILLING CODE 3410-DM-P