Proposal for Danofloxacin

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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: 9450-5-16

January 24, 2005

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 Danofloxacin 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 p.p.m	Column IV Foods
Danofloxacin	Danofloxacin	0.07	Muscle of cattle
		0.07	Liver of cattle
		0.4	Kidney of cattle

Danofloxacin is a synthetic fluoroquinolone antimicrobial and antimycoplasmal drug. It possesses potent in vitro activity against Mannheimia haemolytica, Pasterurella multocida, Haemophilus somnus and Escherichia coli, the bacterial pathogens most commonly associated with bovine respiratory and enteric disease. Danofloxacin has been proposed for administration to beef cattle by subcutaneous injection, for the treatment of bovine respiratory disease (BRD).

VDD has established an ADI of 144 μg/person/day . The withdrawal period is seven days for beef cattle.

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 April 25, 2005. 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.

Your sincerely,

Diane Kirkpatrick
Director General