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Drugs and Health Products

Proposal for Narasin

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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: 9450-5-11

December 5, 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 Narasin in edible tissues of food producing animals as indicated in the following table.

Division 15, Part B of the Food and Drug Regulations for Narasin 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
Narasin Narasin 0.05 Muscle of chickens and swine
0.05 Liver of swine
0.5 Fat of chickens

Narasin is a monovalent polyether ionophore that is a fermentation product of Streptomyces aureofaciens. It is used in meal or pellet feed as an aid in the prevention of coccidiosis and necrotic enteritis in broiler chickens. Narasin is for broilers only and should not be fed to other types of chickens. Also, it is fed to growing-finishing swine for increased rate of weight gain and improved feed efficiency.

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.

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 5, 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 Signature

Diane Kirkpatrick
Director General