September 19, 2019
The U.S. 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 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. The sections in FDPB now include:
- Facility Information
- Process/Product Description
- Vulnerability Assessment
- Mitigation Strategies
- Food Defense Monitoring Procedures
- Food Defense Corrective Action Procedures
- Food Defense Verification Procedures
- Supporting Documents
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 Food Defense Plan Builder v. 2.0 is a desktop tool that resides only on the user's computer. FDA does not track or monitor its use and does not have access to any content or documents saved using this tool. Furthermore, while the content of the tool is aligned with federal regulations, its use does not mean that your food defense plan is approved by the FDA or compliant with the applicable IA rule requirements.
FDA will also 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 at 1 p.m. eastern time. Those interested can register here: https://collaboration.fda.gov/fdpb_v2/event/registration.html
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.
For More Information
- Food Defense Plan Builder
- Protecting the Food Supply from Intentional Adulteration, Such as Acts of Terrorism
- Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
- FSMA Final Rule on Intentional Adulteration