As FDA implements the various sections of the Food Safety Modernization Act (FSMA) through rulemaking, the agency continues to convey a pragmatic approach complicated by regulatory reality. With its latest proposal, FDA attempts to design a system for preventing acts of terrorism impacting food production. In FDA’s words, “food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation.”

The upshot is that large-scale food producers—distributors, small and alcohol beverage producers, and farms are largely excluded—would need to add chapters to their HACCP plans identifying steps in production or locations in their facilities where individuals or groups could poison food and “cause massive public health harm.” These chapters would constitute a “food defense plan” calculated to prevent acts of health terrorism.

FDA does a decent job of mapping out the specifics and exclusions, but long-term implementation is likely to be complicated. Ensuring that food defense plans mesh successfully with existing business needs and production controls will no doubt be challenging. FDA has deemed a variety of specific production steps and facility locations “significant vulnerabilities.” This list and its administration are likely to be the subject of debate and disagreement, and could lead to many future meetings between individual producers and FDA over the adequacy of “mitigation strategies” and their execution.

Bottom line: if the proposal is implemented as written, expect a need for counsel to advise and discuss how to balance regulatory compliance and business efficiency.