After years of delay, the U.S. Food and Drug Administration (FDA) has finalized the Food Safety Modernization Act (FSMA) final rules related to the preventive controls rules for human and animal food. As required by court order, FDA submitted the final rules to the Federal Register on August 31, 2015, and the pre-publication versions became available September 10, 2015. The final rules are set to publish in the Federal Register on September 17, 2015, and the September 17, 2015 date will start the clock on the period of time facilities regulated by either rule will have to reach compliance.
The two rules, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” and "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals," were initially proposed in January and October 2013, respectively, and then supplemented in September 2014. According to FDA, the final rules have elements of both the original and supplemental proposals, in addition to new requirements that are the result of public input received during the comment period for both preventive controls proposals.
Key requirements for both rules include an analysis of hazards and risk-based preventative controls, as well as implementation of Current Good Manufacturing Practice requirements. With these final rules, FDA has also announced it is developing several guidance documents and planning for training and technical assistance efforts.
According to FDA’s settlement in the Center for Food Safety et al. v. Hamburg case, three more FSMA rules will be finalized by October 31, 2015 (Foreign Supplier Verification Program rule, Produce Safety Standards rule and Accreditation of Third Party Auditors rule). The last two FSMA rules will be issued in March and May 2016, respectively (Sanitary Transport of Food and Feed rules and Intentional Contamination rules).
We are in the process of reviewing the final rules and will provide a more detailed analysis as we complete our review.