Vol. 139, No. 25 — December 14, 2005

Registration
SOR/2005-396 November 28, 2005

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1346 — Maximum Residue Limits for Veterinary Drugs)

P.C. 2005-2221 November 28, 2005

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, hereby makes the annexed Regulations Amending the Food and Drug Regulations (1346 — Maximum Residue Limits for Veterinary Drugs).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1346 — MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS)

AMENDMENTS

1. Table III to Division 15 of Part B of the Food and Drug Regulations (see footnote 1) is amended by adding the following before item C.1:

Item No.	Column I Common Name (or Brand Name) of Drug	Column II Name of substance for Drug Analysis Purposes	Column III Maximum Residue Limit p.p.m.	Column IV Foods
C.01	ceftiofur	desfuroyl-ceftiofur (DFC)	0.1	Milk
			1.0	Muscle of cattle, sheep and swine
			2.0	Liver and fat of cattle, sheep and swine
			5.0	Kidney of swine
			6.0	Kidney of cattle and sheep

2. The portion of item M.1 of Table III to Division 15 of Part B of the Regulations in column IV is replaced by the following:

Item No.	Column IV Foods
M.1	Edible tissue of cattle, chickens and turkeys

3. Table III to Division 15 of Part B of the Regulations is amended by adding the following after item P.1:

Item No.	Column I Common Name (or Brand Name) of Drug	Column II Name of substance for Drug Analysis Purposes	Column III Maximum Residue Limit p.p.m.	Column IV Foods
P.1.1	pirlimycin	pirlimycin	0.3	Muscle of cattle
			0.4	Milk
			0.5	Liver of cattle

4. Table III to Division 15 of Part B of the Regulations is amended by adding the following before item T.1:

Item No.	Column I Common Name (or Brand Name) of Drug	Column II Name of substance for Drug Analysis Purposes	Column III Maximum Residue Limit p.p.m.	Column IV Foods
T.01	teflubenzuron	teflubenzuron	0.3	Muscle of salmonids
			3.2	Skin of salmonids

COMING INTO FORCE

5. These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

Under the Food and Drug Regulations, all veterinary drugs must be approved by Health Canada prior to their sale and administration to prevent and treat diseases in animals. Some drugs are only permitted in certain species not intended to be used for foods while others are used in food producing animals. These amendments to the Regulations establish safe limits for residues of the veterinary drugs ceftiofur, monensin, pirlimycin and teflubenzuron in foods originating from animals treated with these particular drugs. These veterinary drugs are an important tool in the production of healthy animals which are destined for use as food.

Acceptable limits of residues of veterinary drugs in food commodities are called maximum residue limits (MRLs). MRLs are the maximum concentrations of residues, expressed in parts per million (ppm) on a fresh weight basis, in edible tissues of food producing animals as a result of the treatment of those animals with veterinary drugs. An MRL is based on the type and amount of residue considered to pose no adverse health effects if ingested daily by humans over a lifetime. There are a number of MRLs already established in Table III to Division 15 of Part B of the Food and Drug Regulations.

In order to determine whether MRLs are safe, scientists in Health Canada review the toxicity and residue depletion data submitted by manufacturers, assess the risks and benefits of the resulting use of the drug and the acceptability of the resulting levels of residues of the drugs that are found in food products. Only when there is assurance that the residues found will not pose any health hazards to consumers can the drug be permitted for administration to food producing animals and the related food products sold in Canada. Extensive studies have determined that the food commodities containing residues of ceftiofur, monensin, pirlimycin and teflubenzuron at levels up to the MRLs listed in the amendments are safe for consumption. These MRLs apply to foods produced domestically or imported into Canada.

Alternatives

The addition of new MRLs for veterinary drugs to Table III to Division 15 of the Food and Drug Regulations can only be accommodated by regulatory amendment. These amendments list new MRLs for ceftiofur, monensin, pirlimycin and teflubenzuron.

Benefits and Costs

The amendments permit the sale of food containing residues of veterinary drugs up to the specified level, as a result of use of these drugs to prevent and treat diseases in food producing animals. These amendments benefit both industry and the consumer by reducing potential losses in production, increasing quality of products and improving availability of certain foods.

The MRLs for pirlimycin are compatible with MRLs for this drug already established by the United States. In addition, the amendments for ceftiofur, in the case of MRLs for milk, muscle of cattle and swine, and liver and fat of cattle and swine, include MRLs that are compatible with levels established by the Joint Food and Agriculture Organization of the United Nations/ World Health Organization Food Standards Programme of the Codex Alimentarius Commission and adopted by the European Union and the United States.

There is no anticipated increase in cost to government from the administration of these amendments to the Regulations. Compliance costs are not a factor as the use of these drugs at the production level is optional.

Consultation

Prior to pre-publication in the Canada Gazette, Part I, consultations on the MRLs for each veterinary drug included in the amendments were conducted individually. The following groups were consulted on all the amendments: national and provincial veterinary associations, veterinary colleges, Canadian Animal Health Institute, Federal/Provincial/Territorial Food Committees, the Canadian Food Inspection Agency, Agriculture and Agri-food Canada, and the officials responsible for international trade of the Department of Foreign Affairs and International Trade (currently under the new Department of International Trade). Additional consultees for each specific veterinary drug are indicated below:

- For ceftiofur: Alberta Milk Producers, British Columbia Dairy Foundation, Canadian Federation of Agriculture, Dairy Farmers of Newfoundland and Labrador, Dairy Farmers of Nova Scotia, Dairy Farmers of Canada, Dairy Farmers of Ontario, Dairy Farmers of Saskatchewan, « Fédération des producteurs de lait du Québec », Mainland Dairymen's Association, Manitoba Milk Producers, Prince Edward Island Dairy Producers Association, « Association des techniciens en santé animale du Québec », provincial milk boards, Canadian Cattlemen's Association, Canadian Meat Council, Canadian Beef Export Federation, Canadian Pork Council, Canadian Swine Breeders Association, Maple Leaf Pork, Canadian Centre for Swine Improvements, Canadian Sheep Federation, Canadian Sheep Breeders' Association, Canadian Equestrian Federation, Canadian Animal Health Coalition, Canadian Council on Animal Welfare, Consumer Association of Canada, Cheminex Animal Health, Nova Scotia College of Agriculture, University of Alberta, University of British Columbia, University of Manitoba, Department of Animal Health, University of Guelph, MacDonald College, McGill University.

- For monensin: Canadian Egg Marketing Agency, Canadian Meat Council, Canadian Poultry & Egg Processors Council, Canadian Turkey Marketing Agency, Chicken Farmers of Canada, Further Poultry Processors Association of Canada, Newfoundland and Labrador Veterinary Licensing Board.

- For pirlimycin: Alberta Milk Producers, British Columbia Dairy Foundation, Canadian Federation of Agriculture, Dairy Farmers of Newfoundland and Labrador, Dairy Farmers of Nova Scotia, Dairy Farmers of Canada, Dairy Farmers of Ontario, Dairy Farmers of Saskatchewan, « Fédération des producteurs de lait du Québec », Mainland Dairymen's Association, Manitoba Milk Producers, PEI Dairy Producers Association, « Association des techniciens en santé animale du Québec », Canadian Animal Health Coalition, Canadian Council on Animal Welfare, Consumer Association of Canada, provincial milk boards, Pharmacia - Animal Health, Nova Scotia College of Agriculture, University of Alberta, University of British Columbia, University of Manitoba, Department of Animal Health, University of Guelph, MacDonald College, McGill University.

For teflubenzuron: Aquaculture Association of Canada, Aquaculture Association of Nova Scotia, British Columbia Salmon Farmers, Canadian Aquaculture Industry Alliance, Fisheries Council of Canada, New Brunswick Salmon Growers Association, Newfoundland Aquaculture Industry Association, Ontario Aquaculture Association, Salmon Health Consortium, Aquaculture Science Branch, Fisheries and Oceans Canada, Newfoundland and Labrador Veterinary Licensing Board.

There were twenty-eight responses received as a result of the above consultations. The letters were generally supportive of the MRLs but they did raise several issues. Health Canada responded in writing to each of these issues, as indicated below, and if necessary, modified the proposed amendments accordingly, prior to pre-publication.

Basis for Approval of MRLs

Under the Food and Drug Regulations, there is a pre-clearance requirement to establish the safety and efficacy of a veterinary drug before it can be used for treating animals. The assessment is based on the best scientific data available and the pattern of consumption of the foods containing the residues of the drug. An MRL can be established only when there is sufficient evidence to indicate that the use of the veterinary drug in food producing animals and the resulting residue of the drug in the food would not pose a hazard to the health of the Canadian consumer. The MRLs are applicable only to residues of the named veterinary drug in the food products specified in the Regulations.

Harmonization with Trading Partners and Trade Implications

The MRLs in the amendments are compatible with those adopted by Canada's trading partners. Efforts to achieve greater harmonization will continue to be supported by Canada and MRLs will be harmonized whenever possible if there are no health and safety concerns. It is not anticipated that the MRLs would have an impact on Canada's activities with major trading partners.

Lack of Quick Screening Tests

There are no quick screening tests available for ceftiofur and pirlimycin in milk. The availability of screening methods is not one of Health Canada's criteria for the determination of an MRL. Screening tests are developed by private industry and if there is a demand for such a test, then a commercial company may undertake to develop one. In the meantime, Health Canada suggested that this concern for a screening test be conveyed to the Canadian Food Inspection Agency, responsible for monitoring residues for compliance with the regulations, other provincial associations and companies that develop such tests.

No additional comments were received as a result of the prepublication of these amendments in the Canada Gazette, Part I, on May 8, 2004. There were no modifications to the amendments after pre-publication.

Compliance and Enforcement

Compliance will be monitored by ongoing domestic and import inspection programs conducted by the Canadian Food Inspection Agency.

Contact

Director General
Veterinary Drugs Directorate
Health Products and Food Branch
Health Canada
11, Holland Avenue
Address Locator 3000A
Ottawa, Ontario
K1A 0K9
Telephone: (613) 954-5661
FAX: (613) 954-5694

Footnote a

S.C. 1999, c. 33, s. 347

Footnote 1

C.R.C., c. 870

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