Current Thinking and Draft Directive on Foreign Material Contamination in HACCP, SSOP, and Prerequisite Programs

Lee Puricelli

Program Analyst

RDDS, OPPD, FSIS

Foreign particlecontamination considered

the hazard analysis

Establishment must havesupporting documentationfor monitoring proceduresfrequencies (417.5(a)(2))

Metal contaminationdetermined to be a food

safety hazard likely to occur

Establishment must havesupporting documentation

for and for selection of CCP (417.5(a)(2))

Establishment must havesupporting documentationfor verification proceduresand frequencies(417.5(a)(2))

CCP establishedCL= “functionalMetal detector”

Establishment must havesupporting documentation

for critical limit (417.5(a)(2))

CCP establishedCL= “functional metal detector”

Product rejected Seeded sample not rejected

Deviation fromthe critical limit

Implement correctiveactions that meet

requirements of417.3(a)

Establishment evaluates

Detector functionalIsolated Incident

Appropriate dispositionof product and recordresults

Detector functionalnot an isolated incidentidentify and eliminate

cause

Appropriate disposition of product

System working

Foreign particle contamination consideredIn the hazard analysis

Foreign particleContamination

Determined to be a Food hazard not

likely to occurEstablishment must have documentation to demonstrate thecontinued effectiveness of the prerequisite program preventingthe hazard from being likely tooccur

No documentationdemonstrating the success or theprerequisite program is unsuccessfulbecause plant is not followingthe program

Prerequisite Program

Establishment musthave supporting

documentation forthe prerequisite

program

No supportingdocumentation –

est. must reassessthe hazard analysis

Establishment must support decisions

during reassessment

Food safetyHazard occurs

Supporting decisions made during reassessment

Implement corrective actionReassess the hazard analysis

Foreign particle contaminationConsidered in the hazard analysis

Foreign particle contaminationDetermined likely to occur

BUT not a food safety hazard

Establishment must Have program

For productwholesomeness

Prerequisite Program

Establishment musthave documentation to demonstrate thatongoing contaminationis not a foodsafety hazard

Foreign particlecontamination occursthat is a foodsafety hazard Appropriate disposition

Of product

System workingImplement corrective actions that meet 417.3(b)

Reassess to determine ifthe food safety hazard needsinclusion in the HACCP plan Support the decisions made during the

reassessment

Foreign particle contaminationconsidered in the hazard analysis

Foreign particlecontamination determined

not likely to occur

Historical Data to supportthis decision

If contamination is determined to NOT be a food safety hazard, the est.

must implement correctiveactions under its SSOPs

9 CFR 416.15

If contamination is determined to be a food safety hazard, the est.must implement correctiveactions that meetrequirements of417.3(b)

Contamination Occurs

Support the decisionsmade during the reassessment