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What is HARPC?

The FDA Food Safety Modernization Act (FSMA) requires food companies to implement Hazard Analysis and Risk Based Preventive Controls, often referred to as HARPC.

The requirements for the hazard analysis and risk based preventive controls are found in the FSMA Preventive Controls Rule for Human Food. Although many people refer to this as “HARPC”, this acronym is not used in the final rule.

Companies need to quickly learn what is in the rule, since most of the industry is expected to be in compliance by September 2016.

In order to comply, facilities that manufacture, process, pack or hold food for sale in the United States will need to have a trained “Preventive Controls Qualified Individual” (PCQI) in place to oversee the preparation and implementation of a “Food Safety Plan”. (There are some exemptions from the preventive controls rule for farms, small facilities and others. These exemptions can be found in the final rule.)

After the compliance date, it will be a Prohibited Act to continue activities without having the Food Safety Plan in place and implemented in the facility, and managed by a PCQI.

The food safety plan requirements include conducting a hazard analysis and implementing risk based preventive controls (referred to by some as HARPC).

Companies must plan ahead and get a trained PCQI in place to establish the Food Safety Plan before the September compliance date. Although many companies have HACCP in place, a HACCP system may not meet all the requirements of the Preventive Controls Rule.

The Food Safety Plan required by the rule includes requirements for supply chain preventive controls, allergen preventive controls and sanitation preventive controls as well as other requirements that may not have been included in a standard HACCP Plan and it may need to be modified to be in compliance.

The FDA has worked with FSPCA to develop a standard curriculum for training the PCQI. The training emphasizes the requirements for the Food Safety Plan.

Taking the standardized class from a PCQI Lead Instructor is one way to ensure that the PCQI that you designate for your facility is appropriately trained. A course taught by a PCQI Lead Instructor will provide a certificate from AFDO to demonstrate that your PCQI has completed the standard training course.

The FSPCA course is also the best way to learn about what is required for a Food Safety Plan under the Preventive Controls for Human food Rule. The two and a half day course covers the development of the Food Safety Plan, required documents and records, and an overview of the rule.

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