The Food and Drug Administration conceived HARPC (Hazard Analysis and Risk-Based Preventive Controls for Human Food), introduced with FSMA, it requires that food-processing companies operate respecting the following guidelines:

  1. Food Safety Plan, every food-processing facility must have an individual that, through a specific training and a certificate released by an acknowledged authority, FSPCA, is able to elaborate a suitable food safety plan;
  2.  Identify Hazards, an identification plan for those hazards such as: non-approved additives, medicine residuals, toxins and radiological hazards;
  3. Validation of Preventive Controls, validating the preventive controls carried out according the proper specific scientific references such as experts’ advice, on-site examinations under the PCQI’s supervision;
  4. Record Keeping, to provide documentary evidence of control and verification practices carried out on the plan in case of both inspection or audit also carried out by FDA;
  5. Continuous Analysis of the Food Safety Plan, a constant update of the food safety plan following each modification within the production processes or any evolution of the expertise.

Both HACCP and HARPC define biological, chemical and physical risks however, HARPC includes allergens, radiological hazards, and intentional adulteration among the chemical risks.

HARPC applies to every processed food product except:

  • Juice (falls under its own HACCP regulation);
  • Alcoholic drinks (Wine, beer and spirit under their own regulation);
  • Fresh seafood (under its own HACCP regulation);
  • Live animals, meat, poultry and egg (under USDA).

In brief, HARPC is like HACCP with specific attention, focus on preventing, and minimize risks.