With the shift from Hazard Analysis and Critical Control Points (HACCP) to Hazard Analysis and Risk-Based Preventive Controls (HARPC), the Food Safety Modernization Act (FSMA) has redefined the way food facilities must treat food safety hazards.

This article reviews the new two-step hazard analysis required under HARPC.

Step 1: Hazard identification

In step one, the company is responsible for identifying any “known or reasonably foreseeable” hazards “that [are] known to be, or [have] the potential to be, associated with the facility or the food.”

Hazards may be biological, chemical (including radiological), or physical. In addition, they may be naturally occurring, unintentionally introduced, or intentionally introduced for economic gain.

This process is similar to hazard identification under HACCP. However, there's one major difference. In sectors like seafood and juice, the industry hazards — and their associated controls — are already well documented by the FDA. HARPC requires facilities to stretch beyond the boundaries of HACCP to identify hazards even where the appropriate preventive control is not known.

Step 2: Hazard evaluation

The evaluation phase is where HACCP and HARPC differ most. Here, the facility must evaluate two things:

  1. The severity of the illness or injury that would happen if the hazard occurred, and
  2. The probability that the hazard will occur in the absence of preventive controls.

The evaluation should be based on the available data, including scientific research, illness, and injury data, and the company's own experience.

Importantly, the hazard evaluation must consider the entire manufacturing process. This includes everything from the raw materials that come into the facility to the trucks that transport the finished product out of the facility. For processors, this means increased responsibility and oversight of everything that happens to their products:

  • Raw materials and ingredients
  • Sanitary design of facility and equipment
  • Employee hygiene
  • Manufacturing processes
  • Cleaning and sanitation
  • Packaging and labeling
  • Storage and distribution
  • Transportation
  • And more…

Following the full hazard analysis, food facilities must:

  • Implement risk-based preventive controls to minimize or eliminate the hazards,
  • Monitor to ensure that preventive controls are consistently performed,
  • Take corrective actions when necessary, and
  • Verify that preventive controls are effective.

Learn more about risk-based preventive controls.