Proposal for Neomycin

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

File No: 9457-5-24

January 2, 2007

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. Since you are the designated contact for your organization, I would appreciate your collaboration in distributing this information to the attention of all interested parties 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 Neomycin in edible tissues of food-producing animals as indicated in the following table:

Column I	Column II	Column III	Column IV Foods
Common Name (Or Brand Name of Drug)	Name of Substance for Drug Analysis Purposes	MRL p.p.m	Foods
neomycin	neomycin	0.5	Muscle, liver, fat of cattle, swine, sheep, goats, chickens, turkeys, ducks.
		10.0	Kidney of cattle, swine, sheep, goats, chickens, turkeys, ducks
		0.5	eggs
		1.5	milk

Neomycin has a long history of use as a veterinary drug. Currently, the only MRL of 0.25 ppm (250 μg/kg) established in Canada in the edible tissues of calves is listed in Table III, part B, Division III of the Food and Drug Regulations. There is a need to provide more MRLs in the edible tissues of other animal species, including milk and eggs to the list of administrative MRLs (AMRLs) with the intention to harmonize trade with other major trading nations. In addition, we have established new set of MRLs in cattle. Therefore, the previously established MRL in calves will be removed. JECFA has done an extensive evaluation on the residues of neomycin in food and established a long list of MRLs in the edible tissues and food products of food producing animals. This list was adopted by Australia in their temporary MRL list and almost identical list was established by the EU in which the only difference is the MRL in kidney tissue of 5000 μg/kg versus 10000 μg/kg by JECFA.

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 2, 2007. Comments should be sent to the attention of Isabelle Caron, Public Involvement Officer, at the above noted address.

Thank you for your cooperation in this matter.

Yours sincerely,

Original signed by

Siddika Mithani, Ph.D
Director General