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Understanding FSMA’s Intentional Adulteration Rule By Bob Hirst, IBWA Vice President of Education, Science, and Technical Relations

“Mitigation Strategies to Protect Food Against Intentional Adulteration,” also known as the Intentional Adulteration Rule (“IA Rule”), was published by the U.S. Food and Drug Administration (FDA) as a final rule on May 27, 2016. IBWA initiated an assessment of the rule to determine its impact on members of the association. Staff quickly found a surprise, and our first thoughts were that FDA had made an error in applying the rule. As you know, IBWA’s Bottled Water Code of Practice has required member bottling facilities to develop and maintain a food defense plan since 2004. The exemptions in the final rule based on company size triggered a reassessment of that policy by the IBWA Technical Committee and Board of Directors. 32



Overview of the Final Rule The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, and economic disruption of the food supply absent mitigation strategies. Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities.

Key Provisions of the Rule FDA has taken an approach similar to the Hazard Analysis Critical

Control Point (HACCP) system, a process adopted by industry for the identification, evaluation, and control of food safety hazards. Each covered facility is required to prepare and implement a food defense plan. This written plan must identify vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions, and verification. A reanalysis is required every three years or when certain criteria are met, including mitigation strategies that are determined to be improperly implemented. The rule and the food defense plan include the following components: Vulnerability assessment. This is the identification of vulnerabilities

Bottled Water Reporter