Production Sequences - Record of Decision - Request for Review of Feed Inspection Policies and Procedures

Analysis

Section 14 (b) of the Feeds Regulations requires that medicated feeds contain the level of medication identified in the Compendium of Medicating Ingredient Brochures (CMIB) or on a veterinary prescription while Section 20 requires that a feed have the chemical composition to ensure it is efficacious for its intended use.

Thorough cleaning of manufacturing and distribution equipment following every batch of medicated feed is impractical and is not required if appropriate precautions are taken. Carryover of drugs in feeds needs to be managed so that it does not negatively impact on animal and human health. Production sequences should be developed to ensure that drug residue carryover is managed to minimize risk to animal and public health. Canadian Food Inspection Agency (CFIA) requires that production sequences are:

1. Consistent with conditions of drug approval
2. Take into consideration production stage and species/class receiving the sequenced feed
3. Factor in drug concentration of medicated feed and intended use of the sequenced feed

The CFIA has developed two inspection documents; the Sequencing Guide and the Sequencing Tool. The Sequencing Guide provides a listing of each approved drug and identifies the species/classes of animals whose feeds are acceptable targets for residual levels of that drug. The Sequencing Tool is a tool used by the inspection staff to determine whether the level of drug in the second batch would be acceptable, e.g., it establishes whether the level is a residual level or a treatment level. The inspection protocol includes a two step process using the Sequencing Guide to determine whether the proposed sequence is generally acceptable and if it is, using the Sequencing Tool to determine whether the calculated level of carryover would be safe.

The CFIA continues to work with Health Canada to identify flexibility for production sequences that are not consistent with drug approvals using the Risk Ranking Model. This is an approach supported by the Medicated Feed Regulations Multi-Stakeholder Working Group. When additional flexibilities are sought, the facility is to provide the scientific data necessary to populate the Risk Ranking Model (details are in the Validation Studies for Modification of Sequencing Guidelines).

Decision

Significant modifications to both the Sequencing Guide (more flexibility for Narasin and Nicarbazin) and the Sequencing Tool (changing the definition of residual level to reflect the lowest level for which there is a CMIB claim) have been made. These revised inspection tools which provide additional flexibility to the industry will be supplied to the inspection staff for use in inspections of commercial and on-farm feed manufacturing facilities.

CFIA has worked with Animal Nutrition Association of Canada (ANAC) to draft acceptable standardized methodology for measuring carryover for regulatory (inspection) purposes. Once finalized, results of carryover studies using the approved methodology may provide additional flexibility for production sequencing if warranted.

In the longer term, the inspection approach remains the same, i.e., a two-step process is used to assess production sequences that determines whether the sequence is generally acceptable using the Sequencing Guide and whether the amount is acceptable using the Sequencing Tool. More time is required to finalize the carryover protocol, for facilities to assess their individual carryover (if they choose to) and to provide additional education regarding application of the Sequencing Tool.  As a result, full implementation of the two step process will be delayed. The Sequencing Guide (Step 1) will continue to be applied and the Sequencing Tool (Step 2) will resume April 1, 2010.

Review Decision made by

CFIA Issue Resolution Working Group

December 17, 2009