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 updated FDPB has been aligned with the requirements in the Intentional Adulteration (IA) rule so that it can be used to easily create food defense plans and support compliance with the rule.
The IA rule 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 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
- Signature
The 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 at: https://collaboration.fda.gov/fdpb_v2/event/registration.html
