E. coli O157:H7 Contamination of Beef Products

The Food Safety and Inspection Service (FSIS) is publishing this document to inform manufacturers of beef products of the Agency's views about the application of the hazard analysis and critical control point (HACCP) system regulations to contamination with Escherichia coli (E. coli) O157:H7. FSIS believes that the availability of certain scientific data on E. coli O157:H7 constitutes a change that could affect an establishment's hazard analysis or alter its HACCP plans for raw beef products. Therefore, under the HACCP regulations, if establishments have not already reassessed their HACCP plans for raw beef products in light of this data, they must do so now. Establishments that have not already reassessed their HACCP plans in light of this data must reassess their HACCP plans to determine whether E. coli O157:H7 contamination is a hazard reasonably likely to occur in their production process. This requirement applies to HACCP plans for all raw beef products, including ground beef, other non-intact beef products, and intact beef products. If reassessment results in a determination that E. coli O157:H7 contamination is a food safety hazard reasonably likely to occur in the establishment's production process, then it must be addressed in a HACCP plan. All establishments producing raw beef products are required to reassess their HACCP plans. However, establishments receiving product for grinding may have purchase specifications requiring all their suppliers to have one or more critical control points (CCPs) validated to eliminate or to reduce E. coli O157:H7 below detectable levels. Such establishments may determine that no additional steps to address this pathogen are necessary in their production process. Establishments adopting this approach should incorporate these purchase specifications and their means of ensuring that their specifications are met in their HACCP plans, in their Sanitation SOPs, which FSIS has recognized as prerequisites for HACCP, or in other prerequisite programs. In addition, FSIS is issuing new guidance material related to the control of E. coli O157:H7 and is making available the Agency's draft comparative risk assessment of intact and non-intact (blade tenderized) steaks. (See ADDRESSES.) Additionally, FSIS will be issuing a revised E. coli O157:H7 sampling and testing Directive and this notice discusses the revisions expected to be made. FSIS invites comments on the matters presented in this notice, on its guidance material, and on the draft comparative risk assessment.