Proposal for Ceftiofur

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Veterinary Drugs Directorate
Holland Cross Complex
Tower A, Ground floor, Suite 14
11 Holland Avenue
Address Locator: 3000A
Ottawa, ON K1A OK9

File No: 9450-5-5

January 8, 2003

The Veterinary Drugs Directorate (VDD) of Health Products and Food Branch, Health Canada is considering regulatory amendments which may be of interest to your organization. As the designated contact person of your organization, I would appreciate your collaboration in distributing this information to the attention of all interested parties in your organization to solicit their comments.

More specifically, the Veterinary Drugs Directorate is proposing to establish Maximum Residue Limits (MRLs) in Table III to Division 15, Part B of the Food and Drug Regulations for Ceftiofur in edible tissues of food producing animals and milk as indicated.

Common name (or brand name of drug): Ceftiofur
Name of substance for the drug analysis purpose: All residues retaining the -lactam structure expressed as desfuroylceftiofur (DFC)
MRL PPM/Food: 0.1 - Milk, 1.0 - Muscle of cattle, swine, and sheep, 2.0 - Liver and fat of cattle, swine and sheep, 5.0 - Kidney of swine, 6.0 - Kidney of cattle and sheep.

Ceftiofur is a third -generation cephalosporin antibiotic active against gram-positive and gram-negative bacteria including -lactamase-producing strains. Ceftiofur is used as a veterinary drug to treat respiratory disease in cattle (including lactating cows), swine, sheep, and horses and also has been approved for foot rot infections in cattle and for the control of early poult mortality in day-old turkeys.

The results of our Health Risk Assessment shows that residues at this concentration will not pose a health risk for consumers. These proposed MRLs will be published in the Canada Gazette, Part I, after consideration of comments from stakeholders.

I would appreciate receiving your comments on this proposal by March 7th, 2003. Comments should be sent to the attention of Dhurata Ikonomi, Public Involvement Officer, at the above noted address.

Thank you for your cooperation in this matter.

Yours sincerely,

Diane Kirkpatrick
Director General