Current Thinking and Draft Directive on Foreign Material Contamination in HACCP, SSOP, and Prerequisite Programs Lee Puricelli Program Analyst RDDS, OPPD, FSIS

Foreign particle contamination considered the hazard analysis Establishment must have supporting documentation for monitoring procedures frequencies (417.5(a)(2)) Metal contamination determined to be a food safety hazard likely to occur Establishment must have supporting documentation for and for selection of CCP (417.5(a)(2)) Establishment must have supporting documentation for verification procedures and frequencies (417.5(a)(2)) CCP established CL= “functional Metal detector” Establishment must have supporting documentation for critical limit (417.5(a)(2))

CCP established CL= “functional metal detector” Product rejectedSeeded sample not rejected Deviation from the critical limit Implement corrective actions that meet requirements of 417.3(a) Establishment evaluates Detector functional Isolated Incident Appropriate disposition of product and record results Detector functional not an isolated incident identify and eliminate cause Appropriate disposition of product System working

Foreign particle contamination considered In the hazard analysis Foreign particle Contamination Determined to be a Food hazard not likely to occur Establishment must have documentation to demonstrate the continued effectiveness of the prerequisite program preventing the hazard from being likely to occur No documentation demonstrating the success or the prerequisite program is unsuccessful because plant is not following the program Prerequisite Program Establishment must have supporting documentation for the prerequisite program No supporting documentation – est. must reassess the hazard analysis Establishment must support decisions during reassessment Food safety Hazard occurs Supporting decisions made during reassessment Implement corrective action Reassess the hazard analysis

Foreign particle contamination Considered in the hazard analysis Foreign particle contamination Determined likely to occur BUT not a food safety hazard Establishment must Have program For product wholesomeness Prerequisite Program Establishment must have documentation to demonstrate that ongoing contamination is not a food safety hazard Foreign particle contamination occurs that is a food safety hazard Appropriate disposition Of product System working Implement corrective actions that meet 417.3(b) Reassess to determine if the food safety hazard needs inclusion in the HACCP plan Support the decisions made during the reassessment

Foreign particle contamination considered in the hazard analysis Foreign particle contamination determined not likely to occur Historical Data to support this decision If contamination is determined to NOT be a food safety hazard, the est. must implement corrective actions under its SSOPs 9 CFR If contamination is determined to be a food safety hazard, the est. must implement corrective actions that meet requirements of 417.3(b) Contamination Occurs Support the decisions made during the reassessment