FSIS Data Analysis and Reporting: Public Health Regulations FY 2021
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 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 (PDF Only).
FSIS has revised one of those decision criteria to take advantage of new data collected through PHIS. The criterion formerly referred to as W3NRs was based on PBIS inspection findings and was temporarily suspended with the implementation of PHIS. In January 2013, FSIS submitted to the National Advisory Committee on Meat and Poultry Inspection (NACMPI) its plans to implement an updated version of the W3NRs, now called the Public Health Regulations (PHRs). The proposal, a supporting report and NACMPI recommendations can be found on the NACMPI web pages.
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. Updates to the list of PHRs as well as the thresholds used to prioritize establishments for PHREs and to alert inspection personnel of elevated PHR noncompliance levels will be announced around July 1 each year with a targeted implementation month of October. The process used to update the list of PHRs is detailed in this report, FY2021 Public Health Regulations (PDF).
| 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 |
| 381.65(a) | Clean and sanitary practices; products not adulterated |
| 381.71(a) | Condemnation on ante mortem inspection |
| 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 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 |
| 416.3(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) | Contents of HACCP Plan |
| 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 |
| 417.5(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 |
| 417.5(f) | Official Review |
| 417.6 | Inadequate HACCP systems |
| 430.4(a) | Lm, post-lethality exposed RTE |
| 430.4(b)(3) | Lm, post-lethality exposed RTE - Alternative 3 |
| 430.4(c)(2) | Lm, documentation that supports decision in hazard analysis |
| 430.4(c)(3) | Lm, maintain sanitation in post-lethality processing environment |
| 310.18(a) | Carcasses, organs, and other parts handled in a sanitary manner |
| 418.2 | Notification of adulterated or misbranded product in commerce |
| 381.65(g) | Procedures for controlling contamination throughout the slaughter and dressing operation |
| 381.76(b)(6)(ii)(A) | NPIS Sorting, Trimming, and Reprocessing |
| 381.76(b)(6)(ii)(D) | Ready-to-Cook verification in NPIS |
| 311.14 | Abrasions, bruises, abscesses, pus, etc. |
| Operation Type | Tier 1* | Tier 2* |
|---|---|---|
| Processing | 3.73% | 2.50% |
| Combination | 9.84% | 5.85% |
