Mitigation Strategies Database
FDA issued a final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration in May 2016. The agency intends to update its tools and educational materials to align with the relevant provisions of the final rule.
The Food Defense Mitigation Strategies Database (FDMSD) is a tool designed to help owners and operators of a food facility with identifying mitigation strategies to protect the food against intentional adulteration, and may assist them with meeting some requirements of the Mitigation Strategies to Prevent Food Against Intentional Adulteration regulation (21 CFR Part 121).
The FDMSD contains a collection of potential mitigation strategies that could be implemented to significantly minimize or prevent significant vulnerabilities at actionable process steps. This collection of strategies was developed in collaboration with other government partners and food industry representatives who participated in the vulnerability assessments that FDA conducted. The FDMSD is intended as a starting point for facilities to consider when identifying potential mitigation strategies. These strategies will provide general ideas of mitigation strategies that facilities can then tailor to the specific characteristics of their actionable process steps. Use of the FDMSD is voluntary. For details about the requirements for mitigation strategies and information to help you identify and implement mitigation strategies for the actionable process steps identified during your vulnerability assessment, see Chapter 3 of FDA’s Draft Revised Guidance entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry”.
The FDMSD includes mitigation strategies for some common points, steps, and procedures that are often found at facilities covered under the IA rule.
The FDMSD is not an exhaustive list of potential mitigation strategies or associated points, steps, or procedures; facilities have the flexibility to identify and implement mitigation strategies that are not contained in the FDMSD. Although in some instances, a single strategy may be sufficient to significantly minimize or prevent significant vulnerabilities, some strategies in the FDMSD may not be suitable alone and may need to be complemented with additional strategy(ies) to sufficiently reduce significant vulnerabilities at an actionable process step. The content in FDMSD is the same in Appendix 2 of FDA’s Draft Supplemental Guidance.
If you have questions, please email FoodDefense@fda.hhs.gov.
Launch the Food Defense Mitigation Strategies Database (FDMSD)
Disclaimer for Food Defense Mitigation Strategies Database
FDA has taken all reasonable precautions in creating the Food Defense Mitigation Strategies Database. However, FDA is not responsible for errors, omissions or deficiencies regarding the tool and the accompanying documentation. The FDMSD is being made available “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 database.
The FDMSD is not an exhaustive list of potential mitigation strategies or associated points, steps, or procedures; facilities have the flexibility to identify and implement mitigation strategies that are not contained in the FDMSD. Although in some instances, a single strategy may be sufficient to significantly minimize or prevent significant vulnerabilities, some strategies in the FDMSD may not be suitable alone and may need to be complemented with additional strategy(ies) to sufficiently reduce significant vulnerabilities at an actionable process step. Responsibility for the interpretation and use of the FDMSD lies solely with the user.
Although the content of the FDMSD is consistent with the Food and Drug Administration’s (FDA) existing regulations and guidance, use of the FDMSD does not constitute FDA approval of mitigation strategies or guarantee compliance with FDA’s requirements. Further, in no event shall FDA be liable for direct, indirect, special, incidental, or consequential damages resulting from the use, misuse, or inability to use the database.
Third parties' use of or acknowledgment of the database does not in any way represent that FDA endorses such third parties or expresses any opinion with respect to their statements.