FSIS Data Analysis and Reporting: Public Health Regulations FY 2025
Public Health Regulations (PHRs) are verified regulations with statistically higher individual noncompliance rates in establishments in the 90 days 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 but gives a statistical association to better align scheduling criteria and agency resources. PHRs are not the only important food safety and public health-related regulations; noncompliance with many other regulations are critical indicators of public health concern but may not be statistically associated with the outlined criteria.
FSIS uses decision criteria to prioritize its Public Health Risk Evaluations (PHREs). The decision criteria include factors such as pathogen testing results, recalls, outbreaks, regulatory findings, and inspection results. The PHREs are reviews of FSIS information for an establishment and are used to determine the need for a Food Safety Assessment (FSA) or Enforcement Action. The PHRE methodology and the decision criteria are described in detail in FSIS Directive 5100.4 —Public Health Risk Evaluation Methodology.
FSIS has revised one of those decision criteria to take advantage of data collected through the Public Health Information System (PHIS). The criterion formerly referred to as W3NRs was based on Performance Based Inspection System (PBIS) inspection findings and was temporarily suspended with the implementation of PHIS in 2011. In January 2013, FSIS submitted plans to the National Advisory Committee on Meat and Poultry Inspection (NACMPI) to implement an updated version of the W3NRs, now called the Public Health Regulations (PHRs).
FSIS implemented the PHR criterion starting with the May 2013 cycle of FSA scheduling. FSIS reviews the list annually, as recommended by NACMPI, and makes updates as needed. FSIS periodically analyzes the PHR process to assess if it is operating as intended. Around July 1 each year, the Agency updates and announces the new fiscal year PHR list as well as the thresholds used to prioritize establishments for PHREs and to alert inspection personnel of elevated PHR noncompliance levels. The new PHR list is implemented October 1. The process used to update the list of PHRs is detailed in FY2025 Public Health Regulations.
Public Health Regulations List, Fiscal Year 2025 (For implementation in October 2024)
Regulation | Description* |
---|---|
301.2_Adulterated | Adulterated |
310.22(b) | Inedible and prohibited SRM for use as human food |
310.22(c) | Disposal of 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(e)(4)(i) | Maintain daily records |
310.22(f)(2) | Use of routine operational sanitation procedures on equipment used to cut through SRMs |
310.25(a) | Verification criteria for E. coli testing meat |
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 |
318.24 | Product prepared using advanced meat/bone separation machinery; process control |
381.1_Adulterated | Adulterated |
381.65(a) | Clean and sanitary practices; products not adulterated |
381.83 | Septicemia or toxemia |
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 |
416.12(d) | Plan list frequency for each procedure & responsible individual |
416.13(a) | Conduct pre-op procedures |
416.13(b) | Conduct other procedures listed in the plan |
416.13(c) | Plant monitors implementation of SSOP procedures |
416.14 | Evaluate effectiveness of SSOP's & maintain plan |
416.15(a) | Appropriate corrective actions |
416.15(b) | Corrective action, procedures for |
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 & sufficient size |
416.2(b)(2) | Walls/floors/ceilings durable, impervious, cleaned & sanitized |
416.2(b)(4) | Inedible from edible separated by time or space |
416.3(b) | Constructed, located & 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 & 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)(4) | List of procedures & 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(b)(1) | Segregate and hold the affected product |
417.3(b)(2) | Determine the acceptability of the affected product |
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 |
417.5(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 |
417.6 | Inadequate HACCP systems |
430.4(b)(3) | Alternative 3 |
430.4(c)(3) | Lm, maintain sanitation in post-lethality processing environment |
430.4(c)(5) | Lm, evaluate control measures in Sanitation SOP |
430.4(c)(6) | Lm, prerequisite program requirements |
310.18(a) | Carcasses, organs, and other parts handled in a sanitary manner |
418.3 | Recall Plans |
381.65(f) | Procedures for controlling visible fecal contamination |
381.65(g) | Procedures for controlling contamination throughout the slaughter and dressing operation |
381.76(a) | Post-mortem inspection, when required, extent |
381.76(b)(6)(ii)(A) | NPIS Sorting, Trimming, and Reprocessing |
381.76(b)(6)(ii)(D) | Ready-to-Cook verification in NPIS |
381.76(b)(6)(ii)(C) | NPIS septicemia/toxemia |
311.14 | Abrasions, bruises, abscesses, pus, etc. |
310.18(c)(1) | Sampling locations |
310.26(b) | Carcass sorting and disposition |
Operation Type | Upper Level** | Lower Level** |
---|---|---|
Processing | 3.50% | 2.35% |
Combination | 6.02% | 3.71% |
** Upper level is the higher threshold at which FSIS will consider the establishment for a Public Health Risk Evaluation. Lower level is the lower threshold at which FSIS inspection personnel will be notified via a PHIS Early Warning Alert that an establishment is at an elevated level.