The Food Defense Plan Builder (FDPB) version 2.0 is a user-friendly tool designed to help owners and operators of a food facility in the development of a food defense plan that is specific to their facility and may assist them with meeting the requirements of the Mitigation Strategies to Prevent Food Against Intentional Adulteration regulation (21 CFR Part 121) (IA rule).
This user-friendly tool harnesses existing FDA tools, guidance, and resources for food defense into one single application. Use of this tool is not required by law (see legal disclaimer) and is not required 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 guides the user through the following sections:
- Facility Information
- Product/Process Descriptions
- Vulnerability Assessments
- Mitigation Strategies
- Food Defense Monitoring Procedures
- Food Defense Corrective Actions Procedures
- Food Defense Verification Procedures
- Supporting Documents
- Food Defense Plan Signatures
For the Food Defense Plan Builder (FDPB) v2.0 to operate correctly, your computer configuration must meet the minimum requirements outlined in the table below. Note that the FDPB does not work on the MAC operating system.
|Computer||2.80 GHz||3.0 GHz|
|Hard Disk Space||100 MB||125MB|
|Operating System||Windows 7||Windows 7, Windows 8.1, and Windows 10|
The Food Defense Plan Builder (FDPB) version 2.0 is a user-friendly tool designed to help owners and operators of a food facility in the development of a food defense plan that is specific to their facility and may assist them with meeting the requirements of the Mitigation Strategies to Prevent Food Against Intentional Adulteration regulation (21 CFR Part 121). A food defense plan is a set of written documents that is based upon food defense principles and incorporates a vulnerability assessment, includes mitigation strategies, and delineates food defense monitoring, corrective action, and verification procedures to be followed. A written food defense plan is essential for you to significantly minimize or prevent significant vulnerabilities related to intentional adulteration of food.
Although the content of the Food Defense Plan Builder v. 2.0 is consistent with the Food and Drug Administration’s (FDA) existing regulations and guidance, use of the Food Defense Plan Builder v 2.0 does not constitute FDA approval of a food defense plan or guarantee compliance with FDA’s requirements.
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. FDA has taken all reasonable precautions in creating the Food Defense Plan Builder v. 2.0 and the documentation accompanying it. However, FDA is not responsible for errors, omissions or deficiencies regarding the tool and the accompanying documentation. The Food Defense Plan Builder and the accompanying documentation are available for download “as is” and without warranties of any kind, either expressed or implied, including, but not limited to, warranties of performance, merchantability, and fitness for a particular purpose. FDA is not making a commitment in any way to regularly update the tool and the accompanying documentation.
Responsibility for the interpretation and use of the Food Defense Plan Builder v. 2.0 and of the accompanying documentation lies solely with the user.
Third parties’ use of or acknowledgment of the tool and its accompanying documentation does not in any way represent that FDA endorses such third parties or expresses any opinion with respect to their statements.
- Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration
- Final Rule: Mitigation Strategies To Protect Food Against Intentional Adulteration
- Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration - What You Need to Know About the FDA Regulation: Small Entity Compliance Guide
- All Food Defense Guidance and Regulations
- Intentional Adulteration Rule Training
If you have additional questions or need more information, please email email@example.com