What does HARPC Mean for Your Business?

If your establishment has a verified HACCP plan, you may feel that you are covered for the new Hazard Analysis and Risk-Based Preventive Controls (HARPC) plan mandated by the Food Safety Modernization Act (FSMA) and administered by the FDA. Not so - HARPC goes beyond HACCP by placing more emphasis on risk prevention. HARPC requires:

• Extensive preventive controls to minimize or prevent the hazards from arising in the first place.
• Implementation of effective monitoring programs to ascertain whether preventive controls are working.
• Corrective Action steps to handle detected deviations.
• Testing to verify that a HARPC plan is working correctly.
• The FDA requires that extensive records be kept, including the processes, testing results, deviations and corrective actions.  A facility must make these records and documentation available to the FDA upon oral or written request.

When Are HARPC Plans Required?

Compliance dates for businesses are staggered over several years. Companies generally must comply with the requirements of HARPC by September 19, 2016. Later compliance dates apply for small and very small businesses, some types of facilities and for certain provisions (e.g., the supply-chain program).

What if I'm Already Certified to a GFSI Scheme?

You are well ahead of the game. GFSI is working closely with the FDA to determine what changes (if any) may be necessary for HARPC alignment within the various GFSI approved schemes.