On Aug. 14, 2012, the Food Safety and Inspection Service (FSIS) issued Directive 5,000.6, “Performance of the Hazard Analysis Verification (HAV) Task.” The HAV is a new procedure under the Public Health Information System (PHIS). When performing the HAV, the FSIS in-plant inspector will review the hazard analyses for each HACCP plan at the facility to determine whether the establishment has addressed all relevant food-safety hazards. Although a HAV is not the same as a Food Safety Assessment, a HAV may result in one.

In brief:

·        The inspector begins with the establishment’s flow diagram.

·        At each step in the flow diagram, the inspector will compare the hazards identified by the establishment to the hazards FSIS has identified in its Hazards and Controls Guide.[i]

·        Regardless of whether the establishment has identified a hazard as reasonably likely to occur (RLTO) or not, it must have support for the determination.

Although the inspector is not to determine adequacy of the supporting documentation, the inspector is to verify that the establishment has:

·        Scientific references to support the effectiveness of the interventions used in the HACCP system;

·        Any data developed by processing authorities or scientific experts to support unique processes or unusual technologies;

·        Supporting documentation for the CCPs and pre-requisite programs; and

·        Additional data to support the adequacy of control measures that do not incorporate exact limits from scientific references.

If the establishment has determined a hazard is not RLTO because of a pre-requisite program, the program is subject to review. The agency may deem that the establishment lacks support for the “not RLTO” determination if there are repetitive failures to follow the pre-requisite program or evidence that the pre-requisite program is not effective in controlling the hazard.

FSIS will begin implementing the HAV task at 30 establishments producing comminuted poultry products in October. The HAV will start nationwide in January 2013. Inspection personnel are not to conduct the initial HAV until scheduled under PHIS. Thereafter, HAVs will be scheduled once a quarter, or more frequently for cause, e.g., repetitive non-compliances. Additionally, a HAV should be performed when there are changes to the establishment’s HACCP plan, such as the addition or removal of a CCP or a reassessment following an unforeseen hazard event.

In the event the inspector is unsure whether there is compliance, the inspector is to reach out to their supervisor. If there is non-compliance, the inspectors are to document in a non-compliance record. The establishment will be expected to reassess its plan to correct any deficiency. One point of note, if the inspector finds the pre-requisite program is inadequate, the establishment must follow § 417.3(b), corrective action for unforeseen hazard, which includes reassessment of the HACCP plan and determination as to whether the product produced is adulterated.

Although the HAV tasks will not be implemented for several months, an establishment would be well advised to review its hazard analysis now and compare it to the FSIS Hazards and Controls Guide. For each determination, the establishment should ensure it has at least some documentation. Finally, the establishment should assess the effectiveness of any pre-requisite program being used to support a determination that a hazard is not RLTO. In the words of the Boy Scouts: Be prepared.