In 2015 the United States FDA published a rule mandating implementation of minimum standards for the hazard analysis and risk-based preventive control (HARPC) provisions of the FDA Food Safety Modernization Act (FSMA). The rule applies to certain unintentional hazards (e.g., microbiological, chemical, physical or radiological hazards) that may occur at a food facility that manufactures, processes, packs or holds human food.

HARPC is similar in concept to hazard analysis and critical control points (HACCP), which is required in the USA for foods such as seafood, juices and USDA-regulated meat and poultry. HARPC is not applicable to those HACCP facilities or to any USDA-regulated facilities (among others).

Since the early 1960s, Good Manufacturing Practices (GMPs) have provided the main food safety framework for most foods regulated by FDA. The current GMP regulations cover general practices to be followed to ensure that food is manufactured, processed, packed and held under sanitary conditions, and that such food is safe, clean and wholesome.

HARPC has the same goals, but the approach is quite different from GMP. HARPC provides a new preventive framework designed to identify specific potential threats to the food supply and take appropriate steps to counter them before any harm occurs.

HARPC requires the owner, operator, or agent in charge of a food facility to prepare a written plan to:

Evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility.
  • Identify and implement preventive controls.
  • Monitor the performance of those controls.
  • Develop corrective actions if preventative controls are not effective.
  • Verify that preventative controls are effective.
FDA additionally requires that facilities take steps to verify the proper functioning of the overall written plan, including:
  • Validation of the preventive controls.
  • Verification that monitoring is being conducted.
  • Verification that appropriate corrective actions are taken
Verification that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the identified hazards that are reasonably likely to occur.