with the passing of the Food Safety Modernization Act (FSMA), the federal government decided to develop Hazard Analysis Risked Based Preventative Controls (HARPC)




As most of you are aware, with the passing of the Food Safety Modernization Act (FSMA), the federal government decided to develop Hazard Analysis Risked Based Preventative Controls (HARPC) as the foundation for food safety models in non FSIS plants as opposed to Hazard Analysis Critical Control Points (HACCP). 

HARPC mandates that facilities:

  •  Conduct a thorough hazard analysis for all food processing procedures
  •  Develop and implement preventative controls, and then monitor the controls' effectiveness
  •  Provide a detailed plan in writing, describing how the hazards will be controlled, the preventative controls put in place, and a schedule and methodology for monitoring the efficiency of the controls
  •  Verify the effectiveness of the controls, also maintaining written records of the verification processes
  •  Reanalyze the HARPC plan at least every three years; more often as new product lines are added, equipment is changed or upgraded, and /or when other changes require a new analysis

Unlike HACCP, HARPC includes planning for potential terrorist acts and/or intentional adulteration and food fraud.  A facility's HARPC, food defense plan should include additional security, such as visitor access and control.


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


The table below further highlights some of the key differences between HACCP and HARPC:







Requires a team

Requires a qualified individual with training and experience


Chemical, Biological, Physical

Chemical, Biological, Physical and Radiological

Critical Control Point (CCP)

Identifies CCPs, doesn’t recognize Preventative Controls

Doesn’t distinguish CCPs from other Preventative Controls


CCPs have a critical limit

Not all Preventative Controls have specific limits


1 year for perishable items, 2 years for nonperishable items

2-year retention plan for all records

Plan Reviews

At least once per year

At least once every three years




A preventative control is defined as a reasonable appropriate procedure, practice or process that a person knowledgeable about the safety of food would employ to significantly minimize or prevent.

Radiological hazards are very rarely encountered in foods.  This hazard was included due to potential sources such as contaminated ground, water or air.  The contamination can be natural and present in the soil or water, which can then be incorporated into the food product during the growing period or manufacturing process.  The other potential source of contamination is related to radiation leaks from nuclear facilities.  In the event of such an accident, the food plant needs to activate a crisis management response per their location to the accident site or in relationship to the sourcing of their raw materials or ingredients if that accident were to occur.






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