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Please note this is an updated version that replaces previous communication o...

Published: Aug 08, 2007

Please note this is an updated version that replaces previous communication on this issue

Canada

Carbadox Notification For U.S. Pork Exports Destined For Canada

In 2001 Canada banned the use of Carbadox, an antibacterial used in pork production, implementing a zero tolerance for Carbadox residues in pork. Canada will enforce this requirement on all imported products. The U.S. Food and Drug Administration (FDA) permits the use of Carbadox (21 CFR 558.115).

The United States and Canada each use a different test to detect Carbadox residues. The sponsor Phibro Animal Health is conducting a study, comparing the two tests. Until the study is complete and the results known the Veterinary Drug Directorate of Health Canada (HC) has issued an interim surveillance and testing program for Carbadox. Canada will conduct a test and release inspection at their expense at the border. In turn, FSIS will continue to test for Carbadox as planned in the 2007 National Residue Program and has agreed to report any positive results, non-violative (0.015-0.03 ppm from liver) and violative (>0.03 ppm from liver), to Canada and to prevent any of that product from entering the Canadian marketplace. 

This measure will be in effect until the release of the final results of the Phibro Animal Health study. According to the FSIS Directive 10800.1, Procedures for Residue Sampling, Testing, and Other Responsibilities for the National Residue Program (July 7, 2007), “Inspection program personnel are to notify the appropriate plant official when they collect a sample and are to give the plant official the flyer ‘Residue Scheduled Sample Information,’ which the laboratories provide in the sample box. FSIS inspection program personnel should inform the establishment the Agency recommends that industry hold these scheduled sample carcasses until FSIS reports the results to prevent a recall if the laboratory detects a residue as a violative level.”

Guidance for Compliance:

1. Producers must adhere to label use and withdrawal statements.   

2. FSIS inspection program personnel will notify the appropriate plant official when a sample for Carbadox residue testing is collected.  The plant official will receive an informational flyer “Residue Scheduled Sample Information,” which the laboratories provide in the sample box.

3. FSIS recommends U.S. pork packing plants hold all carcasses that have been sampled for all residues including Carbadox s until a negative test result is confirmed by FSIS.  A plant may also use traceability programs to ensure that any carcass that is sampled for Carbadox residues does not enter the Canadian food chain*.

4. FSIS inspection program personnel will record the plant official’s decision on whether or not to hold the tested carcass in action block 22 of FSIS Form 10,210-3.

5. FSIS will notify Canada of all positive, non-violative and violative, results*. 

* If a carcass tests positive, this includes results in the non-violative range of 0.015-0.030 ppm, Canada will be notified. It is best to ensure that products from that tested carcass not be shipped to Canada by holding the carcass until a negative result is confirmed by FSIS. The action that Canada may take against U.S. pork in the event of a positive from either U.S. or Canadian tests remains unclear, though a recall is likely.

Please note this is an updated version that replaces previous communication on this issue

Canada

Carbadox Notification For U.S. Pork Exports Destined For Canada

In 2001 Canada banned the use of Carbadox, an antibacterial used in pork production, implementing a zero tolerance for Carbadox residues in pork. Canada will enforce this requirement on all imported products. The U.S. Food and Drug Administration (FDA) permits the use of Carbadox (21 CFR 558.115).

The United States and Canada each use a different test to detect Carbadox residues. The sponsor Phibro Animal Health is conducting a study, comparing the two tests. Until the study is complete and the results known the Veterinary Drug Directorate of Health Canada (HC) has issued an interim surveillance and testing program for Carbadox. Canada will conduct a test and release inspection at their expense at the border. In turn, FSIS will continue to test for Carbadox as planned in the 2007 National Residue Program and has agreed to report any positive results, non-violative (0.015-0.03 ppm from liver) and violative (>0.03 ppm from liver), to Canada and to prevent any of that product from entering the Canadian marketplace. 

This measure will be in effect until the release of the final results of the Phibro Animal Health study. According to the FSIS Directive 10800.1, Procedures for Residue Sampling, Testing, and Other Responsibilities for the National Residue Program (July 7, 2007), “Inspection program personnel are to notify the appropriate plant official when they collect a sample and are to give the plant official the flyer ‘Residue Scheduled Sample Information,’ which the laboratories provide in the sample box. FSIS inspection program personnel should inform the establishment the Agency recommends that industry hold these scheduled sample carcasses until FSIS reports the results to prevent a recall if the laboratory detects a residue as a violative level.”

Guidance for Compliance:

1. Producers must adhere to label use and withdrawal statements.   

2. FSIS inspection program personnel will notify the appropriate plant official when a sample for Carbadox residue testing is collected.  The plant official will receive an informational flyer “Residue Scheduled Sample Information,” which the laboratories provide in the sample box.

3. FSIS recommends U.S. pork packing plants hold all carcasses that have been sampled for all residues including Carbadox s until a negative test result is confirmed by FSIS.  A plant may also use traceability programs to ensure that any carcass that is sampled for Carbadox residues does not enter the Canadian food chain*.

4. FSIS inspection program personnel will record the plant official’s decision on whether or not to hold the tested carcass in action block 22 of FSIS Form 10,210-3.

5. FSIS will notify Canada of all positive, non-violative and violative, results*. 

* If a carcass tests positive, this includes results in the non-violative range of 0.015-0.030 ppm, Canada will be notified. It is best to ensure that products from that tested carcass not be shipped to Canada by holding the carcass until a negative result is confirmed by FSIS. The action that Canada may take against U.S. pork in the event of a positive from either U.S. or Canadian tests remains unclear, though a recall is likely.