The U.S. Food and Drug Administration (FDA) has issued a final rule, Mitigation Strategies To Protect Food Against Intentional Adulteration, requiring domestic and foreign food facilities to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be introduced with the intention of causing wide-scale public health harm.
The rule also specifies that food facilities are required to conduct a vulnerability assessment to identify significant vulnerabilities and actionable process steps, and implement mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation.
This last rule completes the implementation of the FDA Food Safety Modernization Act (FSMA) and is effective beginning July 26, 2016.