USDA-FSIS Publishes FY 2024 PHRs and Thresholds

The U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA’s FSIS) recently posted its fiscal year (FY) 2024 Public Health Regulations (PHR) report. The report covers how FSIS determines PHRs and their thresholds. The FY 2024 PHRs and their thresholds will go into effect October 2023.

Public Health Regulations (PHRs) are verified regulations with statistically higher individual noncompliance rates in establishments in the three months prior to a microbiological positive or a public health-related enforcement action than in establishments with no positives or enforcement actions. This statistical association does not inherently imply that a particular regulation constitutes a more serious food safety concern, rather, it provides a statistical association to help FSIS better align scheduling criteria and agency resources. PHRs are not the only important food safety and public health related regulations, as noncompliance with other regulations remain critical indicators of public health concern but may not be statistically associated with PHR criteria.

FSIS updates its PHRs annually, and uses decision criteria described in FSIS Directive 5100.4 to prioritize establishments for Public Health Risk Evaluations (PHREs), including PHR noncompliance. FSIS has analyzed the most recent data to develop the FY 2024 PHR list, including the thresholds used to prioritize establishments for PHREs and to alert inspection personnel of elevated PHR noncompliance levels.

The PHR list for FY 2024 is as follows, the complete regulation descriptions for which can be read in the 2021 Code of Federal Regulations:

310.18(a): Carcasses, organs, and other parts handled in a sanitary manner
310.18(c): Written procedures to prevent contamination; all swine slaughter
310.18(c)(2)(iii): Records of test results for sampling program
310.18(d): Daily records sufficient to document the implementation and monitoring of contamination control procedures
310.22(c): Disposal of specified risk material (SRM)
310.22(e)(1): Written procedures for removal, segregation, and disposition of SRMs
310.22(e)(2): Appropriate corrective actions
310.22(e)(3): Evaluate effectiveness of procedures for removal, segregation, and disposition of SRMs
310.22(f)(2): Use of routine operational sanitation procedures on equipment used to cut through SRMs
310.3: Carcasses and parts in certain instances to be retained.
318.2(a): All products subject to reinspection by program employees
318.2(d): Removal of U.S. retained by authorized program employees only
381.65(a): Clean and sanitary practices; products not adulterated
381.65(f): Procedures for controlling visible fecal contamination
381.65(g): Procedures for controlling contamination throughout the slaughter and dressing operation
381.65(h): Recordkeeping requirements
381.71(a): Condemnation on ante mortem inspection
381.76(a): Post-mortem inspection, when required, extent
381.76(b)(6)(ii)(A): New Poultry Inspection System (NPIS) Sorting, Trimming, and Reprocessing
381.76(b)(6)(ii)(B): NPIS reprocessing and salvage
381.76(b)(6)(ii)(D): Ready-to-Cook verification in NPIS
381.91(a): Certain contaminated carcasses to be condemned
381.91(b): Reprocessing of carcasses accidentally contaminated with digestive tract contents.
416.1: Operate in a manner to prevent insanitary conditions
416.12(c): Plan identifies procedures for pre-op
416.13(a): Conduct pre-op procedures
416.13(b): Conduct other procedures listed in the plan
416.13(c): Plant monitors implementation of sanitation standard operating procedures (SSOPs)
416.14: Evaluate effectiveness of SSOPs and maintain plan
416.15(a): Appropriate corrective actions
416.15(b): Procedures for corrective action
416.16(a): Daily records required, responsible individual, initialed and dated
416.2(a): Grounds and Pest Control
416.2(b)(1): Sound construction, good repair and sufficient size
416.2(b)(2): Walls/floors/ceilings durable, impervious, cleaned and sanitized
416.2(b)(4): Inedible from edible separated by time or space
416.3(b): Constructed, located and operated in a manner that does not deter inspection
416.3(c): Receptacles for storing inedible material must identify permitted use
416.4(a): Food contact surface, cleaning and sanitizing as frequency
416.4(d): Product processing, handling, storage, loading, unloading, and during transportation must be protected
416.6: Only FSIS program employee may remove "U.S. Rejected" tag
417.2(a)(1): Hazard analysis
417.2(c): Contents of Hazards Analysis and Critical Control Points (HACCP) Plan
417.2(c)(4): List of procedures and frequency
417.3(a)(1): Identify and eliminate the cause
417.3(a)(2): CCP is under control
417.3(a)(3): Establish measures to prevent recurrence
417.3(a)(4): No adulterated product enters commerce.
417.3(b)(3): No adulterated product enters commerce.
417.3(b)(4): Reassessment
417.3(c): Document corrective actions
417.4(a): Adequacy of HACCP in controlling food safety hazards
417.4(a)(1): Initial validation
417.4(b): Reassessment of hazard analysis
417.5(a)(1): Written hazard analysis
417.5(a)(2): Written HACCP plan
417.5(a)(3): Records documentation and monitoring of CCP's and critical limits
418.2: Notification of adulterated or misbranded product in commerce
430.4(a): Listeria monocytogenes, post-lethality exposed ready-to-eat (RTE)
430.4(b)(3): Alternative 3
430.4(c)(2): Listeria monocytogenes, documentation that supports decision in hazard analysis
430.4(c)(3): Listeria monocytogenes, maintain sanitation in post-lethality processing environment
430.4(c)(5): Listeria monocytogenes, evaluate control measures in SSOP.

Compliance by establishments with these regulations will be evaluated and compared to cut points that have been set for two broad categories of establishment operations: Slaughter, and Combination (Processing plus Slaughter). The cut points are, for processing 2.49–3.76 percent, and for combination, 4.44–7.17 percent. The higher end of the range is the threshold at which FSIS will consider the establishment for a PHRE. The lower end of the range is the threshold at which FSIS inspection personnel will be notified via a PHIS Early Warning Alert that an establishment is at an elevated level.