The Food Safety Modernization Act (FSMA) drafted the Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration to prevent public health threats. While most FSMA rules focus on possible hazards, the intentional adulteration rule is singular, in that it provides guidance on mitigation and risk-reduction plans for food processing facilities.
The framework for the intentional adulteration rule and the food defense plan both begin with vulnerability assessments. The goal is to identify substantial vulnerabilities and take the necessary steps to prevent deliberate contamination in those areas. HACCP-style methods where the term “critical control points” is used are similar. When it comes to the intentional adulteration rule, critical control points translate to “actionable process steps,” but the process is the same. Also, in HACCP plans, physical or chemical hazards are the goal, where intentional adulteration focuses more on vulnerabilities that can be mitigated by a food defense plan.
Performing vulnerability assessments to determine areas of operation that a food defense plan should cover is the key to compliance. This intentional adulteration rule is inclusive of all but a few facilities (e.g., dairy) and requires completion of a vulnerability assessment.
Mitigation strategies alleviate significant vulnerabilities at each step. These strategies are tailored specifically to each facility and must match the implemented process steps.
Regulators began enforcement of FSMA’s Intentional Adulteration final rule this year. The essential part of this regulation is that an establishment must have a fully implemented and effective Food Defense Plan.
Bill Theis, senior vice president of quality assurance at Kite Hill, joined us to discuss what this means for food and beverage manufacturers. Throughout his 35-year career, Bill has built highly effective quality cultures by focusing on the integrated efforts affecting products, people, and customers. Before joining Kite Hill, Bill founded Quality Culture Partners, enabling organizations to achieve an effective Quality Culture.