Government Connection

FDA Issues Initial Draft Guidance on FSMA Rules

On August 23, the Food and Drug Administration published initial draft guidance for complying with the Hazard Analysis and Risk-Based Preventive Controls for Human Food regulation.  The draft guidance represents the FDA’s current thinking related to complying with the preventive controls requirements.  The current document only covers 5 of the 14 planned chapters of the guidance.

The initial draft includes chapters covering:

  • The Food Safety Plan
  • Conducting a Hazard Analysis
  • Potential Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Human Food
  • Preventive Controls
  • Application of Preventive Controls and Preventive Control Management Components

Additional chapters will be added as they become available.  A copy of the draft guidance can be found by clicking here.

FDA also announced the extension of certain compliance deadlines related to the following rules:  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.

These extensions will not likely have a major impact on the refrigerated warehousing industry and the main underlying compliance dates for the regulations have not changed.  More information about the extended compliance dates can be found here.

August 29, 2016