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> Proposed rule and Proposed Determination. <SUM> <HD SOURCE="HED">SUMMARY:</HD> FSIS is announcing its proposed determination that raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey products contaminated with certain <E T="03">Salmonella</E> levels and serotypes are adulterated within the meaning of the Poultry Products Inspection Act (PPIA). The proposed determination would establish final product standards based on these <E T="03">Salmonella</E> levels and serotypes and would prevent raw chicken carcasses, chicken parts, comminuted chicken, and comminuted turkey products that contain <E T="03">Salmonella</E> at the levels and serotypes that would render them adulterated from entering commerce. FSIS is also proposing to revise the regulations 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 to clarify that these procedures must include a microbial monitoring program (MMP) that incorporates statistical process control (SPC) monitoring methods, to require sampling at rehang instead of pre-chill, and to require that all establishments conduct paired sampling at rehang and post-chill. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Comments on this proposal must be received on or before October 7, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> FSIS invites interested persons to submit comments on this document. Comments 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> <E T="03">Docket:</E> Go to the Federal eRulemaking Portal at <E T="03">https://www.regulations.gov</E> for access to the rulemaking docket, including any background documents and the plain-language summary of the proposed rule of not more than 100 words in length required by the Providing Accountability Through Transparency Act of 2023. For in-person access to background documents or comments received, call (202) 720-5046 to schedule a time to visit the FSIS Docket Room at 1400 Independence Avenue SW, Washington, DC 20250-3700. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Rachel Edelstein, Assistant Administrator, Office of Policy and Program Development, FSIS, USDA; Telephone: (202) 205-0495. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Executive Summary</HD> FSIS is responsible for verifying that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and properly labeled. In support of this mission, FSIS established a <E T="03">Salmonella</E> verification testing program in 1996 as part of the “Pathogen Reduction; Hazard Analysis and Critical Control Point Systems” (PR/HACCP) final rule (61 FR 38805). Among other things, the PR/HACCP final rule established <E T="03">Salmonella</E> pathogen reduction performance standards for raw product to allow FSIS to verify whether establishments have effective process controls to address <E T="03">Salmonella.</E> The current performance standards for young chicken and turkey carcasses, raw chicken parts, and comminuted chicken and turkey products are represented as a fraction of the maximum number of allowable <E T="03">Salmonella</E> -positive results over a targeted number of samples collected and analyzed in a 52-week moving window. FSIS categorizes establishments based on the <E T="03">Salmonella</E> verification sampling results and posts the performance categorization of all establishments subject to the performance standards on the FSIS website. FSIS uses <E T="03">Salmonella</E> performance standard categorization as a basis to prioritize in-depth evaluations of failing establishments' food safety systems, including their HACCP plan and sanitation Standard Operating Procedures (SOPs). While the results of FSIS' <E T="03">Salmonella</E> verification sampling show that the current prevalence-based performance standards approach has been effective in reducing the proportion of poultry products contaminated with <E T="03">Salmonella,</E> these measures have yet to have an observable impact on human illness rates. The estimated rate of human <E T="03">Salmonella</E> infections from all sources has remained consistent over the last two decades, with over 1.3 million illnesses estimated in the United States each year. Additionally, while current <E T="03">Salmonella</E> performance standards are designed to achieve the Department of Health and Human Services' Healthy People Initiative  <SU>1</SU> <FTREF/> targets for foodborne illness reduction, the 2010 and 2020 Healthy People targets for a reduction in <E T="03">Salmonella</E> infections from all sources were not met. The Healthy People 2030 target is to reduce <E T="03">Salmonella</E> infections from all sources to a national case rate of no more than 11.5 per 100,000 consumers per year. To reach this 2030 target, <E T="03">Salmonella</E> illnesses must be reduced by 25 percent. <FTNT> <SU>1</SU>  Launched by the U.S. Department of Health and Human Services (HHS) in 1980, the Healthy People Initiative sets out to create widely accessible plans to help organizations, communities and individuals improve public health. Each decade, HHS releases new goals after evaluating the successes and areas of growth from the previous ten years. They monitor the progress toward Healthy People's objectives using high-quality data and feedback., the HHS benchmark continues to focus on reducing poultry-based <E T="03">Salmonella</E> infections by 25 percent, a goal that has not been reached over the last decade. The Healthy People 2030 objectives were released on August 18, 2020. </FTNT> Poultry is among the leading sources of <E T="03">Salmonella</E> foodborne illness acquired domestically in the United States. <SU>2</SU> <FTREF/> Therefore, on October 19, 2021, FSIS announced that it was mobilizing a stronger, and more comprehensive effort to reduce <E T="03">Salmonella</E> illnesses associated with poultry products. In the announcement, FSIS stated that it had initiated several activities designed to gather data and information to inform and support future actions related to this new effort. FSIS charged the National Committee on Microbiological Criteria for Food (NACMCF) to provide guidance on the types of microbiological criteria the Agency might use to better prevent <E T="03">Salmonella</E> infections associated with poultry products. The Agency also conducted a risk profile for pathogenic <E T="03">Salmonella</E> subtypes in poultry and developed two quantitative risk assessments <E T="03">—</E> one for <E T="03">Salmonella</E> in chicken and one for <E T="03">Salmonella</E> in turkey. Additionally, FSIS conducted an exploratory sampling program for young chicken carcasses to generate microbial data to help inform future policies and added quantification to its <E T="03">Salmonella</E> testing program. <FTNT> <SU>2</SU>  Interagency Food Safety Analytics Collaboration (FSAC). Foodborne illness source attribution estimates for 2020 for Salmonella, Escherichia coli O157, and Listeria monocytogenes using multi-year outbreak surveillance data, United States. GA and DC: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Food and Drug Administration, U.S. Department of Agriculture's Food Safety and Inspection Service. 2022. Available at: <E T="03">https://www.cdc.gov/ifsac/php/annual-reports/?CDC_AAref_Val=https://www.cdc.gov/foodsafety/ifsac/annual-reports.html.</E> </FTNT> In addition to initiating these activities, on October 17, 2022, FSIS shared with stakeholders a draft regulatory framework that the Agency was considering for a new strategy to control <E T="03">Salmonella</E> in poultry products and announced that FSIS would be hosting a virtual public meeting on November 3, 2022, to discuss the framework. The three components under consideration in the draft framework included: <E T="03">Component One.</E> Requiring that establishments characterize <E T="03">Salmonella</E> as a hazard reasonably likely to occur at receiving and requiring that incoming flocks be tested for <E T="03">Salmonella</E> before entering an establishment. <E T="03">Component Two.</E> Enhancing establishment process control monitoring and FSIS verification. <E T="03">Component Three.</E> Imple ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 546k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━