The first major compliance dates regarding FSMA for large food facilities begin in September 2016. While the major provisions of FSMA are being implemented as planned, FDA issued a final rule that extends and clarifies the compliance dates for certain provisions in four of the seven foundational rules. These changes are part of the FDA’s continuing efforts to make the rules as practical as possible while still protecting public health. The final rule addresses technical issues and better aligns compliance dates across the four rules.
The provisions in the final FSMA rules remain unchanged. FDA also issued a new draft guidance to help industry to comply with certain requirements in the Preventive Controls for Human Food rule. Compliance dates are fast approaching for large food facilities that produce human and animal foods:
- Human food companies other than small and very small businesses must be in compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule by September 19, 2016.
- Animal food companies other than small and very small businesses must be in compliance with Current Good Manufacturing Practices (CGMPs) under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule by September 19, 2016, and with preventive controls by September 18, 2017.
The two CGMP and preventive controls rules—together with the five other foundational rules that will be implemented over the next several years to strengthen FDA oversight of produce, imported foods, sanitary transportation and intentional adulteration—will create the preventive and risk-based food safety system mandated by FSMA and reduce foodborne illness.
The changes impact the compliance dates for certain provisions in these four rules: the two CGMP and Preventive Controls rules for human and animal food, Foreign Supplier Verification Programs (FSVP), and Produce Safety. The changes include providing more time for manufacturers to meet requirements related to certain assurances that their customers must provide, more time for importers of food contact substances, and other extensions to align compliance dates for various other food operations or provide time for FDA to resolve specified issues. The rule also clarifies the timeframe for agricultural water testing.
A draft guidance, now available for public comment, involves five chapters of what will be multi-chapter guidance designed to help businesses comply with the CGMP and Preventive Controls for Human Food Rule. The draft guidance explains FDA’s current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls and includes a discussion about establishing a food safety plan.
FDA will release additional chapters of the draft guidance for public comment as they are completed. The agency plans on releasing all chapters of this draft guidance by early 2018.
Resources:
Compliance Date Extensions and Clarifications for FSMA Final Rules
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food
