Testing Program Critical Control Points (TP-CCP): Characterizing and Optimizing Decision-making Power in Food Safety Testing

Abstract

Foodborne illness affects 48 million people annually in the U.S., resulting in 128,000 hospitalizations and 3,000 deaths, and an estimated economic burden of $17.6 billion. To address this important public health issue, ongoing industry efforts have been undertaken to promote a proactive food safety culture that focuses on prevention-based approaches to food safety. In the 1960s, Good Manufacturing Processes (GMPs) and Hazard Analysis and Critical Control Points (HACCP) were introduced to provide a systematic process to identify and mitigate physical, chemical, and biological risks, and quickly became standard components of a comprehensive quality and food safety program. In 2011, the Food Safety Modernization Act (FSMA) introduced Hazard Analysis and Risk-Based Preventive Controls (HARPC), an expansion of HACCP to products regulated by the United States Food and Drug Administration. This article proposes a complementary program using the HACCP/HARPC construct for the systematic characterization and assessment of analytical tools used in monitoring critical steps in food processes. The Testing Program Critical Control Point (TP-CCP) framework extends the comprehensive HACCP/HARPC model to microbiological monitoring programs (e.g., sampling, testing methodology) to define the theoretical operating limits and realized performance of testing systems. TP-CCP identifies risk mitigation opportunities, supports broad prevention-based control efforts, and establishes a missing feedback loop for continuous improvement in food safety. The proposed TP-CCP ensures a robust network that the food industry can use to obtain a more efficient and reliable testing system to advance public health.