Salmonella Framework for Raw Poultry Products

DEPARTMENT OF AGRICULTURE <SUBAGY>Food Safety and Inspection Service</SUBAGY> <CFR>9 CFR Part 381</CFR> <DEPDOC>[Docket No. FSIS-2023-0028]</DEPDOC> <RIN>RIN 0583-AD96</RIN> <SUBJECT>Salmonella Framework for Raw Poultry Products</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food Safety and Inspection Service (FSIS), U.S. Department of Agriculture (USDA). <HD SOURCE="HED">ACTION:</HD> Notification of public meetings. <SUM> <HD SOURCE="HED">SUMMARY:</HD> FSIS is hosting two virtual public meetings to give stakeholders an opportunity to present their views on and discuss the <E T="03">Salmonella</E> 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 <E T="03">Salmonella</E> Framework raised by stakeholders. FSIS is holding these public meetings to solicit stakeholder views on the proposed <E T="03">Salmonella</E> Framework and to facilitate dialogue among stakeholders and the Agency. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> 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. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> 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 <E T="03">Salmonella</E> Framework for Raw Poultry Products Proposed Rule and Proposed Determination may be submitted by one of the following methods: • <E T="03">Federal eRulemaking Portal:</E> 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: <E T="03">https://www.regulations.gov.</E> Follow the on-line instructions at that site for submitting comments. • <E T="03">Mail:</E> Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Mailstop 3758, Washington, DC 20250-3700. • <E T="03">Hand- or courier-delivered submittals:</E> Deliver to 1400 Independence Avenue SW, Jamie L. Whitten Building, Room 350-E, Washington, DC 20250-3700. <E T="03">Instructions:</E> 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 <E T="03">https://www.regulations.gov.</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Julie Lastra, Director Internal Affairs by telephone at (202) 731-4584 or email at <E T="03">Julie.Lastra@usda.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Background</HD> 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 <E T="03">Salmonella</E> Framework document, a precursor to a proposed rule and determination, which shared the agency's thinking on an alternative approach to reducing <E T="03">Salmonella</E> contamination in raw poultry and related illnesses. <SU>1</SU> <FTREF/> 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 <E T="03">Salmonella</E> Framework for Raw Poultry Products proposed rule and proposed determination (89 FR 64678), which, if finalized, would constitute a new strategy to control <E T="03">Salmonella</E> 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 <E T="03">Salmonella</E> into the processing establishment. <FTNT> <SU>1</SU>  Proposed Regulatory Framework to Salmonella Illnesses Attributable to Poultry. Available at: <E T="03">https://www.fsis.usda.gov/inspection/inspection-programs/inspection-poultry-products/reducing-salmonella-poultry/proposed.</E> </FTNT> 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 <E T="03">Salmonella</E> level and particular serotypes are adulterated as defined in the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 <E T="03">et seq.</E> ). The <E T="03">Salmonella</E> level and serotypes in the proposed final product standards were informed by two peer-reviewed quantitative risk assessments developed by FSIS—one for <E T="03">Salmonella</E> in chicken and one for <E T="03">Salmonella</E> in turkey  <SU>2</SU> <FTREF/> —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, <SU>3</SU> <FTREF/> stakeholder input received at a November 2022 virtual public meeting, <SU>4</SU> <FTREF/> a 2023 National Advisory Committee on Microbiological Criteria for Food (NACMCF) report, <SU>5</SU> <FTREF/> and an externally peer-reviewed 2023 risk profile. <SU>6</SU> <FTREF/> 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 <E T="03">Salmonella</E> at or above 10 colony forming units/per milliliter or gram (10 cfu/mL(g)) in analytical portion ( <E T="03">i.e.,</E> mL of rinsate or gram of product) and contain any detectable level of at least one of the <E T="03">Salmonella</E> serotypes of public health significance identified for that commodity. The proposed <E T="03">Salmonella</E> 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. <FTNT> <SU>2</SU>   <E T="03">Quantitative Risk Assessment for Salmonella in Raw Chicken and Chicken Products</E> and <E T="03">Quantitative Risk Assessment for Salmonella in Raw Turkey and Turkey Products</E> available at: <E T="03">https://www.fsis.usda.gov/science-data/risk-assessments/poultry-risk-assessment-files-salmonella-framework.</E> </FTNT> <FTNT> <SU>3</SU>   <E T="03">Salmonella</E> in Poultry: Research and Science Roundtable. Available at: <E T="03">https://www.fsis.usda.gov/news-events/events-meetings/salmonella-poultry-research-and-science-roundtable.</E> </FTNT> <FTNT> <SU>4</SU>  Public Meeting on Reducing <E T="03">Salmonella</E> in Poultry available at: <E T="03">https://www.fsis.usda.gov/news-events/events-meetings/public-meeting-reducing-salmonella-poultry.</E> </FTNT> <FTNT> <SU>5</SU>  NACMR final report: <E T="03">Response to Questions Posed by the Food Safety and Inspection Service: Enhancing Salmonella Control in Poultry Products</E> (March 13, 2023). Available at: <E T="03">https://www.fsis.usda.gov/policy/advisory-committees/national-advisory-committee-microbiological-criteria-foods-nacmcf/2021.</E> </FTNT> <FTNT> <SU>6</SU>   <E T="03">Risk Profile for Pathogenic Salmonella in Poultry</E> available at: <E T="03">https://www.regulations.gov/docket/FSIS-2023-0028.</E> </FTNT> In the proposal, FSIS requested comments on various aspects of all three Components in the proposed <E T="03">Salmonella</E> Framework. The comment period was originally scheduled to close on October 7, 2024, but was extended until January 17, 2025. <SU>7</SU> <FTREF/> <FTNT> <SU>7</SU>  FSIS Constituent Update—October 11, 2024; FSIS Extends Comment Period on Proposed <E T="03">Salmonella</E> Framework for Raw Poultry Products. Available at: <E T="03">https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-october-11-2024.</E> </FTNT> <HD SOURCE="HD1">Public Meetings</HD> 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 ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 15k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━