FSIS Data Analysis and Reporting: Public Health Regulations FY 2018
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, FY2018 Public Health Regulations (PDF).
Public Health Regulations List, Fiscal Year 2018 (For implementation in October, 2017)
| Regulation | Description |
|---|---|
| 310.3 | Carcasses and parts in certain instances to be retained. |
| 311.14 | Abrasions, bruises, abscesses, pus, etc. |
| 316.6 | Products not to be removed from official establishments unless marked in accordance with the regulations |
| 381.69 | Maximum line speed rates under the New Poultry Inspection System |
| 381.83 | Septicemia or toxemia |
| 416.1 | Operate in a manner to prevent insanitary conditions |
| 416.14 | Evaluate effectiveness of SSOP's & maintain plan |
| 416.6 | Only FSIS program employee may remove "U.S. Rejected" tag |
| 418.3 | Recall Plans |
| 301.2_Adulterated | Adulterated |
| 310.18(a) | Carcasses, organs, and other parts handled in a sanitary manner |
| 310.22(c) | Disposal of SRM |
| 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 |
| 310.25(a) | Verification criteria for E. coli testing meat |
| 317.24(a) | Packaging materials composed of poisonous or deleterious substances |
| 318.1(b) | Only inspected and passed poultry product to enter official establishment |
| 318.2(a) | All products subject to reinspection by program employees |
| 381.1_Adulterated | Adulterated |
| 381.65(a) | Clean and sanitary practices; products not adulterated |
| 381.65(f) | Procedures for controlling visible fecal contamination |
| 381.71(a) | Condemnation on ante-mortem inspection |
| 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)(B) | NPIS reprocessing and salvage |
| 381.76(b)(6)(ii)(D) | Ready-to-Cook verification in NPIS |
| 381.91(b) | Reprocessing of carcasses accidentally contaminated with digestive tract contents. |
| 416.12(c) | Plan identifies procedures for pre-op |
| 416.12(d) | Plan lists 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 |
| 416.15(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 |
| 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(a)(4) | No adulterated product enters commerce. |
| 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 |
| 430.4(a) | Lm, post-lethality exposed RTE |
| 430.4(b)(3) | Alternative 3 |
| Operation Type | Tier 1* | Tier 2* |
|---|---|---|
| Processing | 4.22% | 2.82% |
| Combination | 8.73% | 5.38% |
