Proposal for Enrofloxacin

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

File No: 9450-5-13

February 18, 2004

Dear Stakeholder:

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 Enrofloxacin in edible tissues of food producing animals as indicated in the following table:

Column I Common Name (Or Brand Name of Drug)	Column II Name of Substance For the Drug Analysis Purpose	Column III MRL PPM	Column IV Foods
Enrofloxacin	Desethylene Ciprofloxacin	0.07	Liver of cattle
		0.02	Muscle of cattle

Enrofloxacin is a synthetic fluoroquinolone antibiotic developed for use in cattle for the treatment of bovine respiratory disease. It has a broad spectrum of antibacterial activity that is excellent against gram-negative and good against gram-positive bacteria and Mycoplasma species.

The result of our Health Risk Assessment shows that residues at the above noted concentrations will not pose any undue 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 May 10, 2004. Comments should be sent to the attention of Dhurata Ikonomi, Public Involvement Officer, at the above noted address.

For more information about this antibiotic, please visit our website at the following URL:

http://www.hc-sc.gc.ca/dhp-mps/vet/faq/baytril_qa-qr-eng.php

http://www.hc-sc.gc.ca/dhp-mps/vet/faq/baytril_fact_information-eng.php

Thank you for your cooperation in this matter.

Yours sincerely,

Diane Kirkpatrick
Director General