USE OF RISK ASSESSMENT MODELING TECHNIQUES TO DEVELOP QUANTITATIVE RISK-BASED HAZARD ANALYSIS AND CRITICAL CONTROL POINT (RB-HACCP) PLANS

Abstract

Hazard Analysis and Critical Control Point (HACCP) is the internationally recognized system to assure the safety of food products and the foundation of food safety programs worldwide. However, its success is limited by its inability to relate stringency to measurable public health impacts and its inherent qualitative nature. The aim of this research was to incorporate quantitative microbiological risk assessment (QMRA) techniques into HACCP to develop risk-based HACCP (RB-HACCP) plans. The research hypothesized that the Critical Control Points (CCPs) are steps in the process that significantly reduce the mean and/or variance of a hazard and that these can be identified and quantified using risk assessment modeling techniques such as sensitivity analysis (SA) and what-if scenario analysis, as well as providing a more objective means in considering Critical Limits (CLs). QMRA models were developed for two distinctly different commercial food products, frankfurters and cold-smoked salmon (CSS). The former has a definitive inactivation step while the latter achieves control through a series of partial control steps. Modular Product Pathogen Pathway risk assessment models were developed to identify potential risk-based CCPs (RB-CCPs) for the control of <i>Listeria monocytogenes</i>. Steps of the processes within modules were evaluated and prioritized using SA to determine the relative contribution of the process steps to control <i>L. monocytogenes</i>. What-if scenario analyses were subsequently used to quantitatively determine the consequences of system deviations, thereby allowing risk-based CLs (RB-CLs) to be set and the most-effective risk mitigation strategies to be identified. This conceptual framework, combined with relevant plant-specific data, was used to identify RB-CCPs and RB-CLs, thereby producing RB-HACCP plans that are linked with public health goals to lower the risk of listeriosis. This allowed a direct comparison between current industry HACCP plans for frankfurters and CSS with RB-HACCP plans derived from the risk assessments. The comparison suggests that the use of RB-HACCP plans may offer advantages in developing the “preventive controls” risk management food safety plans required under the FDA Food Safety Modernization Act of 2011.