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Web Content Viewer (JSR 286)

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Web Content Viewer (JSR 286)

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FSIS Data Analysis and Reporting: Public Health Regulations

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. A detailed report on the process used to update the list of PHRs will be posted later in July. View PHRs from Prior Years


Public Health Regulations List, Fiscal Year 2021
(For implementation in October, 2020)

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.

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 listed below.

FY2021 PHR Cut Points

Operation Type Tier 1* Tier 2*
Processing 3.73% 2.50%
Combination 9.84% 5.85%

 

 

* Tier 1 is the higher threshold at which FSIS will consider the establishment for a Public Health Risk Evaluation.  Tier 2 is the lower threshold at which FSIS inspection personnel will be notified via a PHIS Alert that an establishment is at an elevated level.


Historical Information: PHR Archives

 

Last Modified Jul 01, 2020