In a rule released late last week, the FDA is now requiring companies to construct a "food defense plan." This is the first time that companies are being called on to establish a plan to defend against intentional (tortious) attacks on the U.S. food supply. Should such attacks occur, this new rule could provide a platform to the plaintiffs’ bar to attempt to expand the concept of manufacturers’ civil liability for the crimes or intentional torts of third parties in a dramatic new way. We are working on strategies and approaches to deal with this possibility and would be happy to share our strategies with you.
The seventh and final Food Safety Modernization Act (FSMA) rule addresses strategies to mitigate the risks of intentional adulteration of food. Any entity that is required to register with the FDA as a food facility must develop a food defense plan that not only identifies a food facility's areas of vulnerability but also analyzes the potential public health impact of intentional adulteration aimed at wide-scale harm. The plans must evaluate the following:
- Scale and severity of potential public health impact
- Population size that could be exposed
- Product distribution speed and volume
- Number of resulting illnesses and deaths
- Physical accessibility to the product
- Capacity for actual product contamination
The established food defense plans must minimize vulnerabilities to intentional adulteration and manage the identified mitigation strategies by adequately training personnel working in areas of vulnerability. Additionally, the food facility will need to document that adequate monitoring is occurring, and appropriate corrective actions are taken when appropriate mitigation steps fail to occur.
The rule is effective July 26, 2016. Depending on their size, food facilities have three to five years to comply with the new rule.
The new food defense plan rule has far-reaching implications for food companies from preventative and potential litigation perspectives. As experienced litigation defense attorneys, working with our clients on forward-looking defense plans is a key part of our practice. These "risk-assessments" are geared to prevent future injury and risk, much like the defense plans the FDA expects food companies to begin developing.