Validation of Equipment Cleanout (other than Production Sequencing) - Record of Decision - Request for Review of Feed Inspection Policies and Procedures

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Area of Reference

Validation of Equipment Cleanout (other than Production Sequencing)

Compliance Verification System (CVS) Task(s)

1114 and 1113

Effective Date

January 11, 2010

Analysis

Canadian Food Inspection Agency (CFIA) requires that equipment cross utilized for handling medications or prohibited material are subject to procedures to prevent cross-contamination of feeds that may negatively impact human or animal health. In cases where appropriate feed sequencing is not an option and a flush or other physical cleanout is required to control this risk, the specific cleanout procedure used requires validation to demonstrate it is effective for the intended purpose. Given the wide variation in manufacturing practices and equipment that exist and the lack of scientific information regarding appropriate cleanout, there is no one universally accepted validation method (indicating where and how to collect samples). CFIA has discussed, with the Animal Nutrition Association of Canada (ANAC), the importance of both sampling location and sampling methodology when it comes to validating equipment cleanout.

Decision

Requirements on how facilities will validate cleanout procedures for cross-utilized equipment will be contingent on the Transmissible Spongiform Encephalopathy (TSE) risk profile of the facility. All facilities that are high risk for TSE (handle prohibited material and manufacture ruminant feeds) will be required to meet process control validation criteria that demonstrate effective cleanout at each piece of equipment in the manufacturing process. If the high risk TSE facility uses only sequencing, equipment clean out validation is not required.

In facilities that are not high risk for TSE, greater flexibility in the nature of the validation will be accepted. These facilities may validate according to the same criteria established for High Risk TSE facilities or they may employ end product verification that residues are not present.

Task 1113 (Health of Animals Regulations) has been revised to assess validation of process controls to prevent cross contamination with prohibited material for High Risk TSE facilities, incorporating the precautionary approach of testing samples collected from the first portion of the batch at each piece of cross-utilized equipment.

Task 1114 (Feeds Regulations) has been revised to confirm that the facility meets the task standard for validation in the corresponding animal health task or for facilities that are not high risk for TSE; the facility will provide evidence that equipment cleanout procedures were validated through sampling at the exit of each processing stream.

Review Decision made by

CFIA Issue Resolution Working Group
December 17, 2009

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