FDA Extends Compliance Dates on FSMA & Issues New Draft Guidance

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FDA, FSMA, New Draft Guidance, Extends Deadline

The U.S. Food and Drug Administration (FDA) issued a final rule on August 24th that extends and clarifies the compliance dates for certain provisions in four of the seven foundational rules for the Food Safety Modernization Act (FSMA).

The changes, which will 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,” are part of the FDA’s efforts to make the rules as practical as possible while still protecting public health. The changes will impact the following rules:

  • Preventive Controls for Human Food
  • Preventive Controls for Food for Animals
  • Produce Safety Final Rule
  • Foreign Supplier Verification Programs (FSVP)

The FDA also issued five chapters of a multi-chapter draft guidance for public commenting, that is designed to help businesses comply with the CGMP and Preventive Controls for Human Food Rule. The guidance addresses 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.”

All chapters of the new draft guidance are expected to be released by early 2018.

Posted on WholeFoods Magazine Online 8/31/2016