FDA Releases Final Supplemental Draft Guidance On Intentional Adulteration

The FDA released a supplemental draft guidance designed to support compliance with the intentional adulteration rule under the Food Safety Modernization Act.

The final rule on intentional adulteration addresses 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 specific foods or hazards, the intentional adulteration rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration.

This third and final installment of the intentional adulteration rule adds to the previously published draft guidance with chapters covering topics focusing on food defense corrective actions, food defense verification, reanalysis, and recordkeeping. This installment also includes appendices on FDA’s online Mitigation Strategies Database and how businesses can determine their status as a small or very small business under the rule.

Food facilities covered by the final rule are required to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities are also required to ensure that the mitigation strategies are working by implementing mitigation strategy management components.

Under the final rule, food companies must establish and implement written food defense corrective actions procedures that must be taken if mitigation strategies are not properly implemented. The food defense corrective actions procedures must describe the corrective action steps companies would take to ensure that appropriate action is taken to identify and correct a problem that has occurred with implementation of a mitigation strategy and, when necessary, to reduce the likelihood that the problem will recur.

Mitigation strategies are usually implemented to reduce access to the product at a particular point, to reduce the ability of an attacker to contaminate at that point, or both. Food defense corrective actions are intended to address situations where those strategies are not properly implemented.

Food defense verification is the application of methods, procedures, and other evaluations, in addition to food defense monitoring, to determine whether a mitigation strategy or combination of mitigation strategies is or has been operating as intended according to the food defense plan.

Food defense verification activities must be documented and must include, as appropriate to the nature of the mitigation strategy and its role in the facility’s food defense system: verification that food defense monitoring is being conducted; verification that appropriate decisions about food defense corrective actions are being made; verification that mitigation strategies are properly implemented and are significantly minimizing or preventing the significant vulnerabilities; and verification of reanalysis.

The purpose of the reanalysis is to determine whether a food defense plan (FDP) continues to be current and accurately reflects a company’s significant vulnerabilities and to determine whether mitigation strategies and mitigation strategy management components remain appropriate for a facility. A reanalysis of a company’s FDP as a whole must be...

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