Proposal for Doramectin

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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: 9450-5-9

December 05, 2003

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

Division 15, Part B of the Food and Drug Regulations for Doramectin in edible tissues of food producing animals

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
Doramectin	Doramectin	0.03	Muscle of cattle
		0.07	Liver of cattle
		0.01	Muscle of swine
		0.035	Liver of swine

Doramectin is an antiparasitic agent derived from the avermectin family of compounds. The avermectins are highly active broad-spectrum antiparasitic agents, and doramectin is isolated from fermentation of a selected strain of the soil organism Streptomyces avermitilis in the presence of cyclohexanecarboxylic acid. Doramectin in its injectable form is intended for use in cattle and swine at a dose of 0.2 and 0.3 mg/kg bw, respectively, administered as a single injection. Doramectin is also available in its pour-on formulation.

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 March 04, 2004. 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