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HACCP Validation The FSIS Perspective Charles Gioglio FSIS/OPPD Director, Meat and Poultry Advisory Committee Staff The HACCP Plan According to 9 CFR 417.2 (b), “every establishment shall develop and implement a written HACCP plan covering each product produced … whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur . . ..” Food Safety Hazard As stated in 9 CFR 417.2 (a), “A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls.” Hazard Analysis Requires supporting documentation that each step of a HACCP plan accounts for all hazards likely to occur. Validation of the Adequacy of its HACCP plans Section 417.4 of the meat and poultry regulations requires “Every establishment shall validate the HACCP plan’s adequacy in controlling the food safety hazards identified during the hazard analysis.…” What This Means Validation is the process of demonstrating that the HACCP system, if operated as designed, can adequately control identified hazards to produce a safe product. Verification Activities designed to determine that the system is operating as designed. Plant Agency Elements of Validation The scientific or technical justification or documented basis for the system. The initial practical demonstration proving the system will perform as expected. Scientific or Technical Basis The supporting documentation can consist of an article from: A peer-reviewed scientific journal, A documented challenge study, Data underlying published guidelines, or In-house data. Scientific or Technical Basis The documentation must identify: The hazard and pathogen, including the level of hazard prevention or pathogen reduction to be achieved, All associated factors or conditions, iden