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.

Sec. 103 of the Food Safety Modernization Act describes HARPC in the following way:

“The owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 or misbranded under section 403(w), monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice.

From the general statutory definition (see above), 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
  • Reanalyse 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 the site’s food safety management system to ensure compliance with new FDA regulations.

What are the differences from HACCP?

Hazard Analysis and Critical Control Point (HACCP) and current Good Manufacturing Practices (cGMP) are essentially designed to ensure that food is manufactured, processed, packaged and stored in sanitary conditions to prevent post-process contamination.  This ensures the food is safe, wholesome, and without visible quality deterioration.

HARPC applies a similar concept and goal, but the approach is different as HARPC focuses on “preventive controls” in order to identify potential risks or threats to the food supply and implement appropriate controls to proactively prevent contamination.

If you currently function under HACCP guidelines, it is your responsibility to determine if you must comply with HARPC under FSMA.

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