In March 2020, the FDA began inspections to enforce the Intentional Adulteration rule, which is part of the Food Safety and Modernization Act (FSMA).
The final rule on IA addresses hazards that might be introduced deliberately to foods, including acts of terrorism, with the intent to cause widespread harm to public health. Unlike other FSMA rules that address specific foods or hazards, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are particularly vulnerable to intentional adulteration.
This final installment of the IA rule draft guidance adds to earlier guidance with chapters covering topics focusing on food defense corrective actions, food defense verification, reanalysis, and recordkeeping. The installment also includes information on the FDA’s online Mitigation Strategies Database and how businesses can identify their status as a “small” or “very small” businesses under the rule.
Food facilities covered by the rule must develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those weaknesses. The rule also requires these to ensure the mitigation strategies are effective by implementing mitigation strategy management components. Compliance requirements for large facilities began in July 2019.
In this recorded webinar, Earl Arnold, AIB International Global Manager for Food Safety and FSMA, provides an overview of the regulatory requirements, details on the three vulnerability assessment methodologies, and how to calculate public health impact. Earl serves as the lead instructor for AIB’s food defense & food fraud seminars, writes and presents on food defense issues, and has completed training for HACCP, FSMA, and food safety and sanitation. Before joining AIB, Earl had a 15-year military career with the U.S. Army as a food inspection manager.
An overview of the regulatory requirements.
Details on the three vulnerability assessment methodologies.
How to calculate public health impact based on FDA guidance.