Source: FDA, Jan. 2018

At this time, FDA does not intend to enforce certain provisions in four regulations implementing FSMA. Which provisions and why?

The FDA has announced that it does not intend to enforce certain provisions in four of the rules that implement the FDA Food Safety Modernization Act (FSMA). The enforcement discretion covers certain entities or activities covered by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal food rules (PC Human Food and PC Animal Food or CGMP & PC rules), Foreign Supplier Verification Programs rule (FSVP), and the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety rule).

While this enforcement policy is in place, FDA will consider the most effective and practical approaches to address issues that have been raised since the FSMA rules became final and provide long-term certainty for stakeholders.

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