With the May 27th publication of the Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration (commonly referred to as the “Food Defense Rule”), all rules that comprise the Food Safety Modernization Act (FSMA) have been finalized, completing a process of submission, review, and publication that began last September. At this point, processors, manufacturers, distributors, and other organizations within the food industry now face a series of deadlines to achieve compliance with each rule. These deadlines are determined by a given company’s size (in the case of the Food Defense Rule, the deadline ranges anywhere between three to five years from the date of publication).

While each FSMA rules deals with some aspect of food safety, the first six rules all addressed issues of accidental or unplanned contamination that are a simple reality of working with food items. The Food Defense Rule is a bit unique in that it focuses on the intentional contamination of food products with the goal of causing wide-scale panic, harm, and casualty. Security personnel, government officials, and protection agencies have long feared that food companies, with their extensive supply chains that deliver mass quantities of ingestible products to large numbers of people across the country, present a ready-made delivery system for a terrorist action. The Food Defense Rule attempts to combat such an event, requiring each organization that falls beneath its auspices to develop and implement a comprehensive mitigation plan. The plan must be written and include a vulnerability assessment, mitigation strategies (including the steps that will be taken to properly manage these strategies), training programs, and recordkeeping considerations. Implemented plans must undergo a re-analysis every three years, or whenever certain conditions exist (such as improperly implemented strategies).

To read the final version of this rule, please click here.