FDA Publishes Final Rule for Protection Against Intentional Adulteration as Part of Food Safety Modernization Act

FDA has published as part of the Food Safety Modernization Act (FSMA) a final rule concerning mitigation strategies to protect food against intentional adulteration.  The rule will require domestic and foreign food facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (FFDCA) to address hazards that may be introduced with the intention to cause wide scale public health harm.  More specifically, under this regulation, both domestic and foreign food facilities are required to complete and maintain a written food defense plan that assesses their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm. Facilities will now have to identify and implement mitigation strategies to address these vulnerabilities, establish food defense monitoring procedures and corrective actions, verify that the system is working, ensure that personnel assigned to the vulnerable areas receive appropriate training and maintain certain records.