The U.S. Food and Drug Administration’s Food Safety and Inspection Service (USDA’s FSIS) has published its Public Health Regulations (PHRs) for fiscal year 2023 (FY2023). The PHRs, which are updated annually, describe the thresholds that FSIS uses to prioritize establishments for Public Health Risk Evaluations (PHREs) and to alert inspection personnel of elevated PHR noncompliance levels.
PHRs are verified regulations that have statistically higher individual noncompliance rates in establishments during the three-month period prior to a microbiological positive or a public health-related enforcement action. The statistical association does not always imply that a particular regulation constitutes a more serious food safety concern; rather, the statistical associations are leveraged to better align scheduling criteria and agency resources.
FSIS uses decision criteria to prioritize its 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 the 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 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 and its thresholds. The new PHR list is implemented on October 1.