# Presentation: 381517

## 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 rejected

- Seeded 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

- 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 416.15

- 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