USA – The US Food and Drug Administration has launched an updated version of the Food Defense Plan Builder (FDPB) to help companies meet the requirements of the Intentional Adulteration (IA) rule.

The rule, entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration,” under the FDA Food Safety Modernization Act (FSMA) was developed to address hazards that may be intentionally introduced to foods.

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.

FDA says that the plan builder will prompt owners and operators to enter information about their facilities into each section which upon completion, the tool will automatically generate a food defense plan.

Sections covered under the newly launched plan include; facility information, process and product description, vulnerability assessment, mitigation strategies, food defense monitoring procedures, corrective action procedures, verification procedures, supporting documents and signature.

However, the agency noted that “the 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 Food Defense Plan Builder v. 2.0 is a desktop tool that resides only on the user’s computer and FDA does not track or monitor.

However, the agency maintains that the use of does not necessary imply that food operators and processors’ defense plan is approved by the FDA or compliant with the applicable IA rule requirements.

FDA will be holding a webinar to provide stakeholders with a brief demonstration of the Food Defense Plan Builder v. 2.0 and offer a question and answer session about the tool on October 10, 2019.

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