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 FY2024 Public Health Regulations.

** 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.