Vol. 147, No. 11 — May 22, 2013
SOR/2013-87 May 2, 2013
FOOD AND DRUGS ACT
Marketing Authorization for Maximum Residue Limits for Veterinary Drugs in Foods
The Minister of Health, pursuant to subsections 30.3(1) (see footnote a) and 30.5(1)(see footnote b) of the Food and Drugs Act (see footnote c), issues the annexed Marketing Authorization for Maximum Residue Limits for Veterinary Drugs in Foods.
Ottawa, May 1, 2013
Minister of Health
MARKETING AUTHORIZATION FOR MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS IN FOODS
Definition of “List”
1. (1) In this Marketing Authorization, “List” means the List of Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods published by the Department of Health on its website, as amended from time to time.
(2) Words and expressions used in the List have the same meaning as in Part B of the Food and Drug Regulations.
2. When a veterinary drug that is set out in column I of the List or one of its metabolites — and that is analysed as being the substance named in column II — is present in a food that is set out in column III, the food is exempt from the application of paragraphs 4(1)(a) and (d) of the Food and Drugs Act in respect of the drug and its metabolites, if the amount of the substance present in the food does not exceed the maximum residue limit that is set out in column IV for that food and if any other condition that is set out in that column is met.
COMING INTO FORCE
3. This Marketing Authorization comes into force on the day on which it is registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Marketing Authorization.)
Issue and objectives
Recent updates to the Food and Drugs Act that were introduced in sections 30.1 to 30.5 as part of the Jobs, Growth and Long-term Prosperity Act, 2012 (Bill C-38), give the Minister of Health the power to issue Marketing Authorizations and incorporate documents by reference.
A Marketing Authorization (MA) for veterinary drug maximum residue limits is needed to realize the efficiencies from Bill C-38. It will permit the Department of Health to respond more efficiently to new scientific information that impacts the health and safety of Canadians.
- — Exempts certain substances approved as veterinary drugs that could be present in certain foods up to established residue limits, which would otherwise be prohibited from sale in the Food and Drugs Act andthe Food and Drug Regulations; and
- — Allows for the incorporation by reference of the List of Maximum Residue Limits for Veterinary Drugs in Foods (List). This List is based upon the existing Table III of veterinary drug maximum residue limits of Part B, Division 15 of the Food and Drug Regulations.
Description and rationale
A maximum residue limit (MRL) is an amount of drug residue that — if present in the tissue of a food animal or a food product derived from a food-producing animal that has been treated with a veterinary drug — will not pose an unacceptable risk to the safety of the food. This residue, at this level, is considered to pose no adverse health effects if ingested daily by humans over a lifetime.
A Marketing Authorization is a regulation made by the Minister of Health that permits the sale of foods that contain specified substances at specified levels. Marketing Authorizations are limited in what they can do; they only exempt a food from an existing prohibition in the Food and Drugs Act or in the Food and Drug Regulations. Conditions of the exemption may be set by the Minister and documents may be incorporated by reference. Incorporated documents have the force of law and are enforceable.
The Marketing Authorization for veterinary drug maximum residue limits will
- Define what is covered by the MA to match the existing “Table III” of maximum residue limits for veterinary drugs found in Part B, Division 15 of the Food and Drug Regulations.
- Exempt the food containing substances at or below specified levels from paragraphs 4.(1)(a) and (d) of the Food and Drugs Act.
- Exempt the MRL from section B.15.003 of the Food and Drug Regulations.
- Incorporate by reference the List of Maximum Residue Limits for Veterinary Drugs in Foods as a document published by the Department of Health on its Web site as amended from time to time. This list will be incorporated by reference into and form part of the Marketing Authorization regulation. The entries in this list will be included based on assessments of applications for veterinary drugs, new scientific information, or housekeeping. The initial List will reflect the existing “Table III” found in the Food and Drug Regulations.
After this MA comes into force, subsequent changes to the List will be made by updating and publishing an amended list on Health Canada’s Web site. The requirements for the supporting scientific information and the review and consultation process to maintain and amend these lists will be described in a guidance document made available on the Health Canada Web site. The rigour of the scientific assessment of safety will not change. Further to this “reset” of the MRL process, Governor in Council regulations are planned to be prepublished at a later date in order to repeal the existing “Table III” in Part B, Division 15 of the Food and Drug Regulations.
The introduction of the Jobs, Growth and Long-term Prosperity Act has proactively streamlined the process for food additives, and the Department is looking to make the same improvements for efficiencies and burden reduction in the context of veterinary drug MRLs.
Information about this proposal was published in a Notice of Intent (February 2, 2013, for a 60-day comment period) to interested parties, and it is anticipated by stakeholders. No comments or concerns have been raised. Further consultation is not considered necessary at this time, as the MA and associated List reproduce existing veterinary drug MRLs that have previously undergone public consultation and are already available on the Department’s Web site.
Going forward, any proposed changes (e.g. new, revised or removed MRLs) would be the subject of consultation, and the List would then be updated administratively and available on Health Canada’s Web site.
The “One-for-One” Rule does not apply to this proposal as there is no change in administrative costs on business.
Small business lens
The small business lens does not apply to this proposal, as there are no costs (or insignificant costs) on small business.
Implementation, enforcement and service standards
As part of the implementation, Health Canada will make available the List of Maximum Residue Limits for Veterinary Drugs in Foods and guidance on its Web site. Administrative procedures for maintaining and amending the List will also include the ability to track changes over time such that the List as it existed at any specific time can be reproduced. Timelines for all activities will be included in the guidance to allow the Department to monitor and maintain a performance standard when amending the List.
This amendment does not alter existing compliance mechanisms enforced by the Canadian Food Inspection Agency (CFIA).
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Holland Cross, Tower B, 5th Floor
1600 Scott Street