On June 20, 2018, the FDA released draft guidance regarding the FDA’s Mitigation Strategies to Protect Food Against Intentional Adulteration Rule (IA Rule).  This is the first of three installments of guidance the FDA plans to release related to the IA Rule.

The new guidance covers the development of a food defense plan, which includes the following:

  • Vulnerability assessment: an assessment that identifies vulnerabilities in a facility’s food manufacturing processes and provides actionable process steps, which are places in the process where a facility can implement mitigation strategies to minimize or prevent the vulnerability;
  • Mitigation strategies: strategies that significantly minimize or prevent significant vulnerabilities at actionable process steps;
  • Food defense monitoring procedures: procedures, including the frequency with which they are to be performed, for monitoring mitigation strategies to assess whether mitigation strategies are operating as intended;
  • Food defense corrective action procedures: actions taken if the mitigation strategies are improperly implemented based on the nature of the actionable process step and the mitigation strategy; and
  • Food defense verification procedures: verification activities to ensure that monitoring is being conducted and appropriate decisions about corrective actions are being made.

This guidance covers the vulnerability assessment, mitigation strategies, and food defense monitoring procedures. Remaining FDA guidance will cover food defense corrective actions, food defense verification, reanalysis, and recordkeeping.

The guidance also provides an overview of the IA Rule requirements and examples of how facilities may implement such requirements in their operations, and offers an appendix of worksheets facilities can use to develop and document their food defense plans and associated procedures. FDA will continue to update this appendix with resources as additional guidance is released.

Although FDA highlights strategies and methods, such as the Key Activity Types method, for implementing a successful food defense plan, Commissioner Scott Gottlieb highlighted in his statement that this guidance is meant to be flexible to allow for facilities to implement those strategies that are most effective for their practices.

Facilities should use this guidance as a starting point for developing their own food defense plans. The templates and scenarios provide helpful examples for thinking through how to implement such a plan based on a facility’s specific needs. For a more detailed look at the guidance, check out our Client Advisory.

The FDA will accept comments regarding this guidance until December 17, 2018. We’ll continue to monitor and post updates related to forthcoming guidance documents, so be sure to check back as they are released.