FSIS to Finalize HACCP Validation Guidance

Negative comments from small establishments in particular held up the guidance several years ago.

USDA's Food Safety and Inspection Service (FSIS) is releasing updated guidance to help establishments validate their Hazard Analysis Critical Control Point (HACCP) systems, and the agency said it will host a public meeting, available by teleconference, on June 25 to review the guidance and take comments. Based on the history of this effort, which FSIS originally planned several years ago, many opposing comments are likely.

Small establishments in particular claimed new guidance and enforcement by the agency of validation requirements weren't necessary, and the requirements were too costly. The opponents objected to having to "revalidate" their systems.

FSIS answered that objection in its May 29 Federal Register announcement of the new guidance by saying it has added an appendix explaining the need for validation, and some recent investigations show it is necessary. It cited its findings following a 2011 Lebanon bologna outbreak that the establishment's scientific support on file did not match the process the establishment was using to make the bologna; non-O157 positives in 2012 that it concluded likely occurred because of improperly designed interventions; and the chicken pot pie outbreaks in 2007 it concluded may have occurred because of improperly validated cooking instructions.

The agency also said beginning about six months after the final guidance is in place, it intends to begin verifying that establishments comply with all validation requirements.

Written comments may be submitted until July 25, 2013. The public meeting will be held in Washington, D.C. To pre-register in order to attend it, visit http://www.fsis.usda.gov/News_&_Events/meetings_&_events/index.asp.

Some commenters argued very small establishments that can’t afford to comply with validation requirements should have the option to return to "conventional" inspection instead of HACCP.

FSIS' answer was this: "HACCP was implemented in 1996 and has resulted in great improvements in food safety. The Agency is not going back to a command and control inspection approach because it would not provide establishments with the flexibility to design innovative systems that ensure food safety."

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