We have reviewed and analyzed FDA's recently-issued final rule to implement the intentional adulteration provisions of the FDA Food Safety Modernization Act (FSMA). The final rule was published in the Federal Register on May 27, 2016. See Mitigation Strategies to Protect Food Against Intentional Adulteration; Final Rule, 81 Fed. Reg. 34166 (May 27, 2016), available at: https://www.gpo.gov/fdsys/pkg/FR-2016-05-27/pdf/2016-12373.pdf.

The final rule establishes criteria for "food defense" plans that facilities must implement to address hazards that may be introduced with the intention to cause wide scale public health harm. With some exceptions, the rule applies to facilities that manufacture, process, pack, or hold humanfood and that are required to register with FDA.

Please find our summary of the requirements and implications of the final rule here.

The final rule is effective July 26, 2016. Companies generally have 3 years from the effective date to comply with the final rule, i.e., July 26, 2019. Small businesses (< 500 full-time equivalent employees) must comply within 4 years, i.e., July 27, 2020.

We will continue to monitor and report on FDA's activities to implement this rule and other FSMA related activities.