On May 27, 2016, the Food and Drug Administration (FDA) published the seventh and final rule required under the Food Safety Modernization Act (FSMA), imposing new duties on domestic and foreign food companies to prevent intentional adulteration of food. The new rule, like all of the new FSMA rules, is preventative and thus requires implementation of mitigation strategies to avoid an outbreak before it occurs. The FDA website has many free goodies for understanding the new rule, including everything you need to create your own food defense plan, such as a Food Defense Course, Free B's (training packages), and a Food Defense Plan Builder.
The Intentional Contamination rule is effective July 27, 2016 and compliance is required by July 27, 2019. Longer periods are provided for smaller companies. Located at 21 CFR Part 121, the new rule is entitled "Mitigation Strategies to Protect Food Against Intentional Adulteration" and is broken into five subparts:
- Subpart A contains the definitions and general provisions;
- Subpart B lays out the requirements for food defense plans, including vulnerability assessments, mitigation strategies, monitoring procedures, corrective measures, effectiveness verification and reanalysis;
- Subpart C is reserved for future rulemaking;
- Subpart D governs recordkeeping; and
- Subpart E concerns compliance and affirms that failure to comply is a prohibited act. One should never forget that a prohibited act under the Food, Drug and Cosmetic Act is either a misdemeanor or felony, depending on many factors including the severity of the harm inflicted.
While many companies already have written food defense plans that focus on vulnerabilities to anticipate and eliminate potential deliberate contamination, FSMA and the new rule now require companies to complete and maintain a food defense plan. The new regulation is more than a policy to sit in a binder on an office shelf. Now, facilities must not only implement mitigation strategies to identify and address vulnerabilities, but also must have a robust set of procedures for monitoring and taking corrective actions. Moreover, the plan must provide for training and establish procedures to ensure the defense plan is effective, and companies must maintain records to prove compliance.
This new 216 page rule is not a stand-alone piece of the FSMA puzzle, but is designed to integrate into the more than 3,750 pages of new FSMA regulations to prevent problems that have not yet occurred. In the words of the FDA commissioner: "[t]he rule will work in concert with other components of FSMA by preventing food safety problems before they occur."
The final rule takes a Hazard Analysis Critical Control Point (HACCP)-type approach to intentional adulteration, similar to the approach used in the preventive controls rule, to require mitigation strategies that are applied to high vulnerability locations in food production.
Under the new rule, registered food facilities are required to complete a vulnerability assessment of their production system and identify "actionable process steps," which are points, steps, or procedures in a food process that require mitigation strategies to reduce the risk of intentional adulteration. A vulnerability assessment, the required actionable process steps, mitigation strategies and procedures for food defense monitoring, corrective actions and verification must be documented in a written food defense plan. Facilities are also required to have a qualified person overseeing the food defense plan. This person is responsible for compliance and must ensure that personnel assigned to the vulnerable areas receive appropriate training and maintain records for food defense monitoring, corrective actions, and verification activities.
The real burden of FSMA's shift to prevention has yet to be realized. In the meantime, ensuring compliance, including compliance by vendors and suppliers, is a massive undertaking for any food company. It will take years to fully incorporate all of FSMA's seven new rules.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
