Clarification Creates Confusion: Final Comments Received On FSIS' Preliminary Validation Guidance
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In late 2008, the FSIS announced that it intended to issue a Federal Register Notice to better explain the validation requirements under its HACCP regulations.
The Agency deemed this clarification necessary because of the “widespread lack of understanding of validation that FSIS has found among establishments, whether large or small HACCP in size or high or low in production volume, and because of the food safety problems that have occurred as a result.”
Unfortunately, the FSIS’s attempt to clarify has created some confusion and much concern. In the past year and a half, the meat industry and its trade associations have given considerable feedback to the Agency regarding validation. Even before the FSIS even issued its preliminary “Draft Guidance for HACCP System Validation” in March 2010, nine trade associations banded together to submit their comments to FSIS on the issue. Since opening the period for public feedback, FSIS has received almost 2,000 comments.
The thrust of the confusion and concern lies with the FSIS’s expectations for microbiological testing under the guidelines. Currently, the guidelines state that “establishments would need to provide support in instances where they believe microbiological testing data is not needed to demonstrate the effectiveness of the HACCP system in controlling biological food safety hazards.” Although the Agency has explained that the guidelines will not impose new microbiological testing requirements on establishments, there is distrust on the issue, particularly by small processors.
Some confusion has already been dispelled through the comment process, however, which highlights the importance of all processors – large and small – being well versed in the draft guidelines and the changes which need to be incorporated. Following an initial review of comments, the FSIS released a Fact Sheet addressing some concerns. The FSIS Fact Sheet confirmed that, among other things, no microbiological testing would be required for "well-established processes", and that establishments would only need to validate one plan per HACCP category.
The final day to submit comments on the preliminary draft guidance is Saturday, June 19, 2010. The Agency plans to complete a final review of the comments on the preliminary draft guidance and then issue an updated draft document in July 2010 for a second round of comments. The FSIS will also hold two public meetings regarding the updated draft.
Hopefully, the FSIS’s willingness to go through a lengthy drafting and comment process will result in true clarification and, ultimately, fewer of the food safety confusion which spurred the Agency to reevaluate its position on validation.
