2024-27280. Salmonella Framework for Raw Poultry Products

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Department of Agriculture

Food Safety and Inspection Service

1. 9 CFR Part 381
2. [Docket No. FSIS-2023-0028]
3. RIN 0583-AD96

AGENCY:

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

ACTION:

Notification of public meetings.

SUMMARY:

FSIS is hosting two virtual public meetings to give stakeholders an opportunity to present their views on and discuss the Salmonella Framework for Raw Poultry Products proposed rule and proposed determination. The first meeting will focus on the proposed final product standards under Component Three of the proposed Framework. The second meeting will focus on Component Two's proposed regulatory amendments to enhance establishment process control monitoring and will also address additional aspects of the proposed Salmonella Framework raised by stakeholders. FSIS is holding these public meetings to solicit stakeholder views on the proposed Salmonella Framework and to facilitate dialogue among stakeholders and the Agency.

DATES:

The virtual public meetings will be held on Tuesday, December 3, 2024, from 1 p.m.-4 p.m. Eastern Standard Time (EST) and Thursday, December 5, 2024, from 1 p.m.-4 p.m. EST.

ADDRESSES:

The meetings will be virtual and will be viewed via the Teams link provided by email when you register for the meetings. Attendees must be pre-registered for the meetings. See the pre-registration instructions under “Registration and Meeting Materials.”

Written comments on the Salmonella Framework for Raw Poultry Products Proposed Rule and Proposed Determination may be submitted by one of the following methods:

• Federal eRulemaking Portal: This website provides the ability to type short comments directly into the comment field on this web page or attach a file for lengthier comments. Go to: https://www.regulations.gov. Follow the on-line instructions at that site for submitting comments.
• Mail: Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Mailstop 3758, Washington, DC 20250-3700.
• Hand- or courier-delivered submittals: Deliver to 1400 Independence Avenue SW, Jamie L. Whitten Building, Room 350-E, Washington, DC 20250-3700.

Instructions: All items submitted by mail or electronic mail must include the Agency name and docket number FSIS-2023-0028. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Julie Lastra, Director Internal Affairs by telephone at [phone] or email at [e-mail].

SUPPLEMENTARY INFORMATION:

Background

FSIS is the public health agency in USDA whose mission is to ensure that meat, poultry, and egg products are safe, wholesome, and properly labeled and packaged. In October 2022, FSIS published a Salmonella Framework document, a precursor to a proposed rule and determination, which shared the agency's thinking on an alternative approach to reducing Salmonella contamination in raw poultry and related illnesses.^[1] The Framework document was informed by months of information-gathering and discussions with a wide range of stakeholders, researchers, and scientists. On August 7, 2024, FSIS published the Salmonella Framework for Raw Poultry Products proposed rule and proposed determination (89 FR 64678), which, if finalized, would constitute a new strategy to control Salmonella in poultry products. The proposed rule and determination consist of three components. Component One focuses on a non-regulatory approach for mitigating the risk of introducing Salmonella into the processing establishment.

Component Two of the proposal would revise the regulations in 9 CFR 381.65(g) and (h) that require that all poultry slaughter establishments develop, implement, and maintain written procedures to prevent contamination by enteric pathogens throughout the entire slaughter and dressing operation and maintain records documenting those procedures. FSIS is proposing to amend these regulations to establish new requirements pertaining to how establishments monitor and document whether their processes for preventing microbial contamination are in control. The proposed revisions are intended to clarify existing regulatory requirements related to process control monitoring in 9 CFR 381.65(g) and (h). Under this proposal, establishments would be required to incorporate statistical process control (SPC) monitoring principles into their microbial monitoring programs (MMPs).

Component Three of the proposed Framework would establish final product standards that would define whether certain raw poultry products contaminated with a certain Salmonella level and particular serotypes are adulterated as defined in the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.). The Salmonella level and serotypes in the proposed final product standards were informed by two peer-reviewed quantitative risk assessments developed by FSIS—one for Salmonella in chicken and one for Salmonella in turkey ^[2] —and a thorough review of multiple FSIS efforts initiated to inform the proposal, including scientific information provided at a February 2022 research and science roundtable,^[3] stakeholder input received at a November 2022 virtual public ( print page 92608) meeting,^[4] a 2023 National Advisory Committee on Microbiological Criteria for Food (NACMCF) report,^[5] and an externally peer-reviewed 2023 risk profile.^[6] The proposed final product standards would apply to raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey. As stated in the proposal, FSIS has tentatively determined that these products are adulterated if they contain any type of Salmonella at or above 10 colony forming units/per milliliter or gram (10 cfu/mL(g)) in analytical portion ( i.e., mL of rinsate or gram of product) and contain any detectable level of at least one of the Salmonella serotypes of public health significance identified for that commodity. The proposed Salmonella serotypes of public health significance identified for raw chicken carcasses, chicken parts, and comminuted chicken are Enteritidis, Typhimurium, and I 4,[5],12:i:-, and for raw comminuted turkey are Hadar, Typhimurium, and Muenchen.

In the proposal, FSIS requested comments on various aspects of all three Components in the proposed Salmonella Framework. The comment period was originally scheduled to close on October 7, 2024, but was extended until January 17, 2025.^[7]

Public Meetings

FSIS is announcing that it will hold two virtual public meetings during the open comment period. The first meeting will be held on Tuesday, December 3, 2024, from 1 p.m.-4 p.m. EST, and will focus on the final product standards under Component Three. The second will be held on Thursday, December 5, 2024, from 1 p.m.-4 p.m. EST, and will focus on the enhanced process control monitoring provisions under Component Two and any additional issues raised by stakeholders on the proposed Framework. The purpose of the meetings is to give stakeholders an opportunity to present their views on certain aspects of the proposed Salmonella Framework and to facilitate discussion among stakeholders and the agency. An agenda will be published online before the public meetings. FSIS will finalize the agenda on or before the meeting dates and post it on the FSIS website for the December 3, 2024 meeting at: https://www.fsis.usda.gov/​news-events/​events-meetings/​product-standards-and-salmonella-framework-raw-poultry-products and the December 5, 2024 meeting at: https://www.fsis.usda.gov/​news-events/​events-meetings/​process-control-monitoring-and-salmonella-framework-raw-poultry.

Registration and Meeting Materials

There is no fee to register for the meetings, but pre-registration is mandatory for participants attending. All attendees must register online by visiting the event page for the December 3, 2024 meeting at: https://www.fsis.usda.gov/​news-events/​events-meetings/​product-standards-and-salmonella-framework-raw-poultry-products and the December 5, 2024 meeting at: https://www.fsis.usda.gov/​news-events/​events-meetings/​process-control-monitoring-and-salmonella-framework-raw-poultry. After registering, they will receive an email acknowledging their registration. Stakeholders interested in presenting their views on a particular topic must notify FSIS when they register and must submit a brief description of the information they would like to present. Stakeholders interested in presenting must register by November 26, 2024. FSIS will review the stakeholder submissions and extend invitations for selected stakeholders to speak at the meetings. The Agency's goal is to have presentations from a wide variety of stakeholders, including industry, consumer groups, and academia. FSIS will provide time for the stakeholders in the larger audience to provide input and ask the presenting stakeholders questions. Attendees that do not plan to speak at the meetings may register at any time up to the day of the meeting.

Transcripts

As soon as the meeting transcripts are available, they will be accessible on the FSIS website for the December 3, 2024 meeting at: https://www.fsis.usda.gov/​news-events/​events-meetings/​product-standards-and-salmonella-framework-raw-poultry-products and the December 5, 2024 meeting at: https://www.fsis.usda.gov/​news-events/​events-meetings/​process-control-monitoring-and-salmonella-framework-raw-poultry.

USDA Non-Discrimination Statement

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(1) Mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410; or

(2) Fax: [phone] or [phone]; or

(3) Email: [e-mail].

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

Paul Kiecker,

Administrator.

Footnotes

1.  Proposed Regulatory Framework to Salmonella Illnesses Attributable to Poultry. Available at: https://www.fsis.usda.gov/​inspection/​inspection-programs/​inspection-poultry-products/​reducing-salmonella-poultry/​proposed.

2.   Quantitative Risk Assessment for Salmonella in Raw Chicken and Chicken Products and Quantitative Risk Assessment for Salmonella in Raw Turkey and Turkey Products available at: https://www.fsis.usda.gov/​science-data/​risk-assessments/​poultry-risk-assessment-files-salmonella-framework.

3.   Salmonella in Poultry: Research and Science Roundtable. Available at: https://www.fsis.usda.gov/​news-events/​events-meetings/​salmonella-poultry-research-and-science-roundtable.

4.  Public Meeting on Reducing Salmonella in Poultry available at: https://www.fsis.usda.gov/​news-events/​events-meetings/​public-meeting-reducing-salmonella-poultry.

5.  NACMR final report: Response to Questions Posed by the Food Safety and Inspection Service: Enhancing Salmonella Control in Poultry Products (March 13, 2023). Available at: https://www.fsis.usda.gov/​policy/​advisory-committees/​national-advisory-committee-microbiological-criteria-foods-nacmcf/​2021.

6.   Risk Profile for Pathogenic Salmonella in Poultry available at: https://www.regulations.gov/​docket/​FSIS-2023-0028.

7.  FSIS Constituent Update—October 11, 2024; FSIS Extends Comment Period on Proposed Salmonella Framework for Raw Poultry Products. Available at: https://www.fsis.usda.gov/​news-events/​news-press-releases/​constituent-update-october-11-2024.