Since making the Guidance available, the agency has issued a clarification to validation and acknowledged safe harbors. F.S.I.S. has also stated the guidance is being created to help establishments understand existing requirements that do not impose new testing or microbiological requirements on establishments.
“A.M.I. applauds these statements and actions,” said Scott Goltry, A.M.I. vice president for food safety and inspection services. “A.M.I. also supports the premise of not imposing new testing or microbiological requirements on establishments. At issue is what type of data is needed demonstrate that a process or intervention achieves intended results.”
If specified parameters are met – i.e. in a safe harbor document – the need to supply effectiveness data would not be required, Goltry further explained. A.M.I. believes if the specified parameters are not met or if the supporting document does not apply to the process, then more information would be needed to confirm validation.
Goltry commented that the interpretation of validation given in the Guidance focuses on the effectiveness of the establishment’s H.A.C.C.P. system and the prescriptive use of requiring microbiological testing, which does not does not embrace the theory of H.A.C.C.P. as defined in the Pathogen Reduction; Hazard Analysis and Critical Control Point Systems; Final Rule.
At present, A.M.I. members are engaged in a review of not only what validation is but also how validation would be completed to meet the current regulations and will also address the use of prerequisite programs. The A.M.I. Interim Validation Guide will be available this summer and will be shared with F.S.I.S.
Goltry’s comments presented at the FSIS public meeting on June 14 are available online.