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Web Content Viewer (JSR 286)

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FSIS Data Analysis and Reporting: Public Health Regulations

FSIS uses decision criteria to prioritize its Food Safety Assessments (FSAs). FSAs are in-depth evaluations of an establishment's food safety system. FSAs can be routine, or for cause. The decision criteria include factors such as pathogen testing results, recalls, outbreaks, regulatory findings, and inspection results. These criteria are described in detail in FSIS' Public Health Decision Criteria Report (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 making updates as needed. Updates 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, FY2015 Public Health Regulations (PDF).


Public Health Regulations List, Fiscal Year 2015

Regulation
Verified
Description
310.18 Contamination of carcasses, organs, or other parts
310.3 Carcasses and parts in certain instances to be retained
381.83 (HIMP ONLY) Septicemia or toxemia
416.1 Operate in a manner to prevent insanitary conditions
416.14 Evaluate effectiveness of SSOP's and maintain plan
301.2_Adulterated Adulterated
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
318.2(d) Removal of U.S. retained by authorized Program employees only
381.1_Adulterated Adulterated
381.22(c) Conduct hazard analysis and develop HACCP plan for new product
381.65(a) Clean and sanitary practices; products not adulterated
381.65(e) Zero-tolerance for visible fecal material entering chiller
381.91(b) Reprocessing of carcasses accidentally contaminated with digestive tract contents
381.94(a) Verification criteria for E. coli testing poultry
381.94(b) Exceeds Pathogen reduction performance standards for Salmonella
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 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
416.5(c) Employees who appears to have any abnormal source of microbial contamination
417.2(c) Contents of 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)(1) Segregate and hold the affected product
417.3(b)(2) Determine the acceptability of the affected product
417.3(b)(3) Deviation not covered (unforeseen hazard)
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
417.5(f) Official Review
430.4(a) Lm, post-lethality exposed RTE
430.4(b)(2) Alternative 2
430.4(b)(3) 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

Compliance by establishments with these regulations will be evaluated and compared to cut points that have been set for three broad categories of establishment operations: Slaughter, Processing and Combination. The cut points are listed below.

Cut Points, Fiscal Year 2015

Operation Type FY 2015 PHR Cut Points FY 2014 PHR Cut Points
Processing 6.55% 6.09%
Combination 9.37% 9.21%


Note: For FY 2015, the Slaughter category has been combined with the Combination category.
 


Historical Information

Public Health Regulations List, Fiscal Years 2013-2014
Regulation
Verified
Description
301.2_Adulterated The term adulterated applies to any carcass, part thereof, meat or meat food product under one or more of a number of circumstances (See 9 CFR).
310.22(e)(1) Establishments that slaughter cattle or process the carcasses or parts of cattle must develop, implement, and maintain written procedures for the removal, segregation, and disposition of specified risk materials.
310.22(e)(3) Establishments that slaughter cattle or process the carcasses or parts of cattle must routinely evaluate the effectiveness of their procedures for the removal, segregation, and disposition of specified risk materials in preventing the use of these materials for human food and must revise the procedures whenever any changes occur that could affect the removal, segregation, and disposition of specified risk materials.
310.22(f)(2) Use of routine operational sanitation procedures on equipment used to cut through SRMs if processing cattle under 30 months before cattle 30+ months
381.1_Adulterated The term adulterated applies to any poultry product under one or more of a number of circumstances (See 9 CFR).
381.144(a) Packaging materials not to be composed of any poisonous or deleterious substance
381.65(a) Operations must adhere strictly to clean and sanitary practices; products must not be adulterated.
381.65(e) Zero-tolerance for visible fecal material entering chiller
381.83 Septicemia or toxemia
381.91(a) Certain contaminated carcasses to be condemned
381.91(b) Reprocessing of carcasses contaminated with digestive tract contents must be under the supervision of an inspector and thereafter found not to be adulterated.
416.1 Operate in a manner to prevent insanitary conditions to ensure product is not adulterated.
416.15(a) Appropriate corrective actions
416.15(b) Procedures for corrective action
416.14 Evaluate effectiveness of SSOPs and maintain plan.
416.16(a) Maintain daily records documenting the implementation and monitoring of SSOP and corrective actions taken.
416.3(b) Constructed, located and operated in a manner that does not deter inspection to determine sanitary condition.
416.4(d) Product processing, handling, storage, loading, unloading, and during transportation must be protected.
416.6 Any room, compartment, equipment or utensil found insanitary or could create adulterated product must be marked with a US Rejected tag and cannot be used until made acceptable. Only FSIS program employee may remove "U.S. Rejected" tag.
417.2(c)(4) List of procedures and frequency must be in the HACCP plan.
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)(1) Segregate and hold the affected product.
417.3(b)(3) No adulterated product enters commerce.
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(a)(3) Reassessment, at least annually or when necessary
417.4(b) Reassessment of hazard analysis
417.5(a)(1) Establishment shall maintain a written hazard analysis.
417.5(a)(3) Records documentation and monitoring of CCPs and Critical Limits as prescribed in the HACCP plan

Compliance by establishments with these regulations will be evaluated and compared to cut points that have been set for three broad categories of establishment operations: Slaughter, Processing and Combination. The cut points are listed below.

Cut Points, Fiscal Years 2013-2014
Operation Type FY13 Cut Point
Slaughter 14.36%
Processing 6.09%
Combination 9.21%
Last Modified Jul 25, 2014