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AMI Supports Improvements to HACCP Systems Validation Draft Guidance; Offers Assistance in Developing Education Program

Tuesday, June 15, 2010

(American Meat Institute)

AMI voiced its support for the Food Safety and Inspection Service’s (FSIS) recent statements and actions made after the issuance of Draft Guidance: HACCP Systems Validation. The comments were made during a public meeting this week held in Washington, D.C.

Since making the Guidance available, the agency has issued a clarification to validation and acknowledged safe harbors.

The agency has also stated that the guidance is being created to help establishments understand existing requirements that do not impose new testing or microbiological requirements on establishments.

“AMI applauds these statements and actions,” said Scott Goltry, AMI vice president for food safety and inspection services. “AMI 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.”

Goltry further explained if specified parameters are met -- i.e. in a safe harbor document -- the need to supply effectiveness data would not be required. AMI 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.

In his comments, Goltry pointed out that the interpretation of validation given in the Guidance focuses on the effectiveness of the establishment’s HACCP system and the prescriptive use of requiring microbiological testing, which does not does not embrace the theory of HACCP as defined in the Pathogen Reduction; Hazard Analysis and Critical Control Point Systems; Final Rule.

AMI members are currently 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 AMI Interim Validation Guide will be available this summer and will be shared with FSIS.

To view Goltry’s comments presented at the FSIS June 14, 2010 public meeting in their entirety, click here: http://www.meatinstitute.org/ht/a/GetDocumentAction/i/60299



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