Proposal for Ractopamine

Veterinary Drugs Directorate
Holland Cross Complex
Ground floor, Suite 14
11 Holland Avenue
Address Locator: 3000A
Ottawa , ON K1A OK9
File No: 9450-5-20

August 26, 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. 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 Ractopamine (ractopamine hydrochloride) 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 DRUG ANALYSIS PURPOSES	COLUMN III MRL p.p.m.	COLUMN IV FOODS
Ractopamine	Ractopamine	0.04	Muscle of swine
Ractopamine	Ractopamine	0.12	Liver of swine
Ractopamine	Ractopamine	0.14	Kidney of swine

Paylean 20 and 100 Premixes containing ractopamine hydrochloride are indicated for use in swine for improved carcass index, increased carcass leanness and carcass dressing percent, improved rate of weight gain and feed efficiency.

VDD has established an ADI of 1.4 µg/kg/bw . The withdrawal period is zero (0) day for swine.

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 November 24, 2005. Comments should be sent to the attention of Marc M Plante, Public Involvement Officer, at the above noted address.

Thank you for your cooperation in this matter.

Yours sincerely,

Kathy Dobbin

Acting Director General