What is HARPC?

HARPC stands for “Hazard Analysis and Risk-Based Preventive Controls.”  It is one of many new provisions of the FDA Food Safety Modernization Act, a sweeping food safety legislation amending the Food, Drug and Cosmetic Act that was enacted in January of 2011.  HARPC requires virtually every food manufacturer, packer, bottler and storage facility to identify food safety and adulteration risks associated with their foods and processes, to implement controls to minimize the risks, to verify that the controls are working, and to design and implement corrective actions to address any deviations from the controls that might arise.  Everything in a HARPC plan must be properly documented and must conform to FDA’s standards and definitions surrounding facilities, controls, hazards, and the adulteration of foods.  HARPC requires each food facility to document all aspects of its plan, periodically review it, constantly maintain it, and document its verification steps.

There are certain exemptions provided for in the law, but except for very small businesses, most food will originate in or come through facilities that are subject to HARPC to some degree. For all food supply chains, domestic or imported, HARPC represents a substantial new regulatory requirement that must be taken seriously.  Companies must create their unique HARPC plan, update it as required by FSMA, and produce the documentation to FDA upon oral request or inspection.

HARPC.com is the place for food companies to understand the relevant law, the FDA regulations as they become available, and FDA guidances. You will be able to assess appropriate action steps for each requirement, read updates in plain language, understand the implementation timelines, and obtain qualified subject matter assistance developing, reviewing, modifying, or adjusting any food HARPC plan.  So what exactly is involved in a HARPC plan?   Keep Reading//