# Presentation: 721823

## HACCP Validation The FSIS Perspective

- Charles Gioglio
- FSIS/OPPD
- Director, Meat and Poultry Advisory Committee Staff

## The HACCP Plan

- According to 9 CFR 417.2 (b), “every establishment shall develop and implement a written HACCP plan covering each product produced ... whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur . . ..”

## Food Safety Hazard

- As stated in 9 CFR 417.2 (a), “A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls.”

## Hazard Analysis

- Requires supporting documentation that each step of a HACCP plan accounts for all hazards likely to occur.

## Validation of the Adequacy of its HACCP plans

- Section 417.4 of the meat and poultry regulations requires “Every establishment shall validate the HACCP plan’s adequacy in controlling the food safety hazards identified during the hazard analysis....”

## What This Means

- Validation is the process of demonstrating that the HACCP system, if operated as designed, can adequately control identified hazards to produce a safe product.

## Verification 

- Activities designed to determine that the system is operating as designed.
- Plant
- Agency

## Elements of Validation 

- The scientific or technical justification or documented basis for the system.
- The initial practical demonstration proving the system will perform as expected.

## Scientific or Technical Basis

- The supporting documentation can consist of an article from:
- A peer-reviewed scientific journal,
- A documented challenge study,
- Data underlying published guidelines, or
- In-house data.

## Scientific or Technical Basis

- The documentation must identify:
- The hazard and pathogen, including the level of hazard prevention or pathogen reduction to be achieved,
- All associated factors or conditions, identify which processing steps will achieve the specified reduction or prevention, and how these processing steps will be monitored.

## Scientific or Technical Basis

- Related to the specific hazard or pathogen
- Identifies specific control parameters

## Practical Demonstration

- Early testing in-plant through
- Observation
- Measurements
- Test Results
- Designed to demonstrate that plant can routinely meet scientifically documented parameters
- Records kept

## Agency’s Verification

- FSIS verifies that the scientific and technical materials exist and provide a scientific and technical basis for the CCPs and Critical Limits.
- Ascertain the status of reference material in scientific community and review it.

## Documentation Criteria

- Is the research widely accepted by the relevant professionals?
- Is this the best available scientific data?
- Is it considered dated, but still a reliable approach to control?

## Documentation 

- Supporting Documentation - **Study data  (plant specific or broad based) - a copy of the article or study not just a reference to the article or study.**
- Recorded Documentation (Practical Demonstration) - **Records confirming that the parameters or specifications in the study, or article can be routinely met in the plant setting.****	**

## CCP Example

- Product        --         **Beef Carcass**
- Hazard         --         ***Salmonella***
- CCP/ CL       --          **Steam **
**                                ****pasteurization/ **
**                                ****6.5 seconds **
**                                ****exposure at **
**                                ****180°F (82.2°C)**

## Documentation Example

- Supporting Documentation - **Published scientific articles stating time and temperature of process and the level of pathogen reduction**
- Recorded Documentation - **Records confirming the steam pasteurization process can be applied per specifications in the article in the plant setting.**

##          CCP EXAMPLE

- Product     --
- Hazard      --
- CCP / CL   --

- Ground Beef
- Foreign Material
-             (Metal)
- Functioning Metal
- 		Detector Calibrated at 2mm.

## Documentation Example

- Supporting Documentation – Documented **Risk Assessments, Journal Articles, Regulatory Compliance Guides**
- Recorded Documentation - **Records confirming that the equipment as installed can routinely detect material at sizes specified in the articles or guides.**

## Reassessment

- According 417.4, every establishment shall reassess the adequacy of the HACCP plan and Hazard Analysis yearly or when changes are made.
- Reassessment includes reviewing scientific validation documentation and adding new information when possible.