2024-11310. 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.

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 [phone].

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 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]

• 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 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.

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 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 [phone] (voice and TTY) or contact USDA through the Federal Relay Service at [phone]. 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 [phone].

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: [phone]; or

(3) Email: [e-mail].

USDA is an equal opportunity provider, employer, and lender.

Done at Washington, DC.

Paul Kiecker,

Administrator.

Footnotes

1.  See: https://www.govinfo.gov/​content/​pkg/​FR-2016-04-06/​pdf/​2016-07330.pdf.

2.  See: https://www.govinfo.gov/​content/​pkg/​FR-2016-04-06/​pdf/​2016-07330.pdf.