Proposal for Trenbolone Acetate

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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: 9450-5-22

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 Trenbolone Aceteate (TBA) in edible tissues of food-producing animals as indicated in the following table:

Trenbolone Aceteate (TBA) is a synthetic steroid with anabolic properties. It is administered to cattle either alone or in combination with estradiole-17 β as subcutaneous implant in the ear to improve body weight, feed conversion, and nitrogen retention. It is usually implanted 60-90 days before the intended date of slaughter.

VDD has established an ADI of 0.02 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