On May 9, 2012, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS or Agency) published a notice in the Federal Register requesting comments on the Agency’s revised draft guidance on the requirements for validation of an establishment’s Hazard Analysis and Critical Control Points (HACCP) system (Compliance Guideline). This is the second draft of the Compliance Guideline; the first draft was released in March 2010.

FSIS will require HACCP validation to consist of two parts: First, an establishment must gather scientific or technical support for the judgments it makes in designing its HACCP system. Second, the establishment must gather evidence from its HACCP system while it is operating to demonstrate that the establishment is able to implement the “critical operational parameters necessary to achieve the results documented in the scientific or technical support” that form the basis of its HACCP system.

The Compliance Guideline recommends that scientific or technical support used in designing a HACCP system be from one of the following sources: Published processing guidelines; a scientific article from a peer-reviewed journal; a challenge or inoculated pack study that is designed to determine the lethality or stabilization of a process; data gathered in-house; or regulatory performance standards.[3] In order for the scientific or technical support to be considered effective, it must identify: (1) The hazard that the measures are intended to address; (2) the expected level of hazard reduction or prevention that the measures will achieve; (3) the critical operational parameters, such as time, temperature, humidity, and pH, that must be met for the measures to be effective; (4) the processing steps necessary to achieve the specified level of hazard reduction or prevention; and (5) how the processing steps can be monitored.[4]