The U.S. Food and Drug Administration (FDA) is moving forward with implementing the FDA Food Safety Modernization Act (FSMA), with the first major compliance dates beginning next month for large food facilities.
On August 23, 2016, the FDA issued a final rule that extends and clarifies the compliance dates for certain provisions in four of the seven foundational rules. The changes announced in the final rule 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. Specifically, changes include but are not limited to, 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.
Five chapters of what will be multi-chapter guidance designed to help businesses comply with the CGMP and Preventive Controls for Human Food Rule, has been made available for comment as of August 24, 2016. The FDA will release additional chapters of the draft guidance for public comment as they are completed. The agency plans on releasing all chapters of this draft guidance by early 2018.
Please contact Davidson Law Group, P.A., if you have any questions about FSMA.