Proposal for Zeranol
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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:
9450-5-23
April 18, 2006
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 Zeranol in edible tissues of food-producing animals as indicated in the following table:
| COLUMN I |
COLUMN II |
COLUMN III |
COLUMN IV |
COMMON NAME
(OR BRAND NAME OF DRUG) |
NAME OF SUBSTANCE FOR DRUG ANALYSIS PURPOSES |
MRL
p.p.m. |
FOODS |
| Zeranol |
Zeranol |
0.002 |
Muscle of cattle |
| Zeranol |
0.01 |
Liver of cattle |
Zeranol is a synthetic non-steroidal estrogenic growth promoter. It is an anabolic agent which is an estrogenic derivative of naturally occurring zearalenone. Zearalenone occurs in corn, barley, wheat hay, and oats. Zeranol improves the rate of weight gain and feed efficiency in food animals following implantation. Presently marketed products consist of small pellets each containing 12 mg zeranol. These pellets, three (Ralgro) or six (Ralgro Magnum) are implanted subcutaneously into the ears of cattle.
VDD has established an ADI of 0.5 µg/kg/bw.
The withdrawal period is zero (0) day for 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 July 12, 2006 . 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,
Siddika Mithani, Ph.D
Director General
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