The U.S. Food and Drug Administration (FDA) has launched an updated version of the Food Defense Plan Builder (FDPB) to help companies meet the requirements of the Intentional Adulteration (IA) rule under the FDA Food Safety Modernization Act (FSMA).

The rule, entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration,” was developed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause widespread harm to public health. Unlike the other FSMA rules that address unintentional food safety hazards, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration.

Food facilities covered by the rule are required to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies. The original version of the FDPB was created under a voluntary framework to assist owners and operators of food facilities with developing customized food defense plans and was released in 2013, prior to the publication of the final IA rule. The updated tool has been aligned with the requirements in the IA rule so that it can be used to easily create food defense plans and support compliance with the rule.

The plan builder will prompt owners and operators to enter information about their facilities into each section. Once all the sections are completed, the tool will automatically generate a food defense plan.

Owners and operators of food facilities should note that use of the FDPB version 2.0 is not required by law and is not necessary to comply with the IA rule. FDA expects this tool to supplement and not replace other education, training, and experience needed to understand and implement the requirements of the IA rule.

The first compliance date for largest facilities subject to the IA rule arrived on July 26, 2019. Earlier this year, the FDA announced that inspections would begin in March 2020 to allow industry time with forthcoming materials, training, and tools, such as this updated FDPB.

Press release

In This Article

  1. Food Safety and Defense

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