FSMA Preventive Controls and HARPC

Hazard Analysis and Risk-Based Preventive Controls (HARPC) is the food safety management system applied under Preventive Controls regulation of the U.S. Food Safety Modernization Act (FSMA).

Food and feed companies (including non-U.S. based facilities) who manufacture, process, pack, and/or hold food for sale in the U.S. are subject to Preventive Controls for Human Food or Preventive Controls for Animal Food regulation with the exception of facilities already in compliance with other U.S. Food and Drug Administration (FDA) or United States Department of Agriculture (USDA) regulations.

In general, the regulations require facilities to identify food safety and adulteration risks associated with their foods and processes, implement controls to minimize the risks, verify controls are effective, and apply corrective actions to address deviations from applied controls.

From the general statutory definition, 7 major tasks are defined in the regulation:

  • Identify hazards
  • Apply risk-based preventive controls to mitigate hazards
  • Monitor the effectiveness of controls
  • Apply corrective actions where controls are not correctly implemented
  • Verify the implementation and effectiveness of controls
  • Reanalyze the food safety plan
  • Maintain records and documentation

 In light of the regulations, food manufacturers should consider a two-fold approach:

  1. Understand how requirements of Preventive Controls regulation compare to HACCP principles, and
  2. Update a site’s food safety management system to ensure compliance with FDA regulations.