HACCP vs HARPC: Answers to Common Questions


The Food Safety Modernization Act (FSMA) brings with it a whole new set of rules, regulations, and acronyms. This post provides a quick overview of two rules that look similar but are really quite different: Hazard Analysis and Critical Control Points (HACCP) and Hazard Analysis and Risk-Based Preventive Controls (HARPC).

The biggest difference between the old regulations and the new is the focus on prevention. The goal of HACCP is to ensure food manufacturing, processing, and packaging take place in sanitary conditions so that the food is safe to eat. While the goal of HARPC is the same, it requires a proactive, science-backed approach to identify threats to food safety before they occur. Below we describe the main differences between HACCP and HARPC.

Where are the standards recognized?

  • HACCP is a global standard.
  • HARPC is a US standard, applicable to certain FDA-regulated products.

Who must comply?

  • HACCP is mandatory primarily for facilities processing juice and seafood, as well as USDA-regulated meat and poultry.
  • HARPC applies to almost all other food processing facilities, including all companies required to register with the FDA in accordance with the Bioterrorism Act. There are six categories of exemption to HARPC:
    • Companies covered under the juice and seafood HACCP rules
    • Companies exclusively regulated by the USDA, such as those that handle, process, and ship meat, poultry, and eggs
    • Companies subject to the FDA’s Standards for Produce Safety Authorities, including farms, growers, and harvesters
    • Low-acid and acidified canned food processors
    • “Small” or “very small” businesses
    • Companies whose previous three-year average product value was less than $500,000

What hazards are considered?

  • HACCP covers chemical, biological, and physical hazards.
  • HARPC covers the three above plus radiological hazards, intentionally introduced hazards (e.g., acts of terrorism), and unintentionally introduced hazards.

How are the plans implemented?

  • HACCP focuses on critical control points (CCPs), which are points at which a control is required to prevent or reduce a food safety hazard. Hazard analyses are based on industry-wide documentation, and implementation relies on sanitation standard operating procedures (SSOPs).
  • For HARPC, a hazard analysis is only the first step. The rule also requires companies to develop science- or risk-preventive controls, validate that the controls work, and verify that they are implemented consistently. Each facility is responsible for performing and documenting its own research.

How often do you need to review and update your plan?

  • HACCP plans are reviewed once a year or whenever there is a significant change.
  • HARPC plans are reviewed once every three years or whenever there is a significant change.

What happens if you don’t comply?

  • Noncompliance with HACCP most often results in fines and a plan for re-evaluation.
  • Noncompliance with HARPC can result in anywhere from a suspension of the facility’s registration to criminal prosecution.

If you’re required to comply with HARPC, don’t wait! By starting the process now, you can ensure you’re ready when the inspectors come knocking on your door.

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