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Vol. 138, No. 19 — May 8, 2004 Regulations Amending the Food and Drug Regulations (1346 — Maximum Residue Limits for Veterinary Drugs)Statutory Authority Food and Drugs Act Sponsoring Department Department of Health REGULATORY IMPACT Description Under the Canadian 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. Amendments to the Regulations are proposed to 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 (p.p.m.) 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 at Health Canada review the toxicity and residue depletion data submitted by manufacturers, and 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 product 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 proposed amendments are safe for consumption. These MRLs would 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 proposed amendments would list new MRLs for ceftiofur, monensin, pirlimycin and teflubenzuron. Benefits and costs The proposed amendments would permit the sale of food containing residues of veterinary drugs up to the specified level, as a result of the use of these drugs to prevent and treat diseases in food-producing animals. These proposed amendments would benefit both industry and the consumer by reducing potential losses in production, increasing the quality of products and improving the availability of certain foods. The MRLs for pirlimycin are compatible with MRLs for this drug already established by the United States. In addition, the proposed 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 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 proposed amendments to the Regulations. Compliance costs would not be a factor, as the use of these drugs at the production level is optional. Consultation Prior to prepublication in the Canada Gazette, Part I, consultations on the MRLs for each veterinary drug included in these proposed amendments were conducted individually. The following groups were consulted on all the proposals: national and provincial veterinary associations, veterinary colleges, the 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 of the University of Guelph, MacDonald College of 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 of the University of Guelph, MacDonald College of 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 of 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 prepublication. 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 on 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 proposed 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 proposed 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 proposal 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. Compliance and enforcement If these proposed amendments are adopted, compliance would be monitored by ongoing domestic and import inspection programs conducted by the Canadian Food Inspection Agency. Ms. Diane Kirkpatrick, Director General, Veterinary Drugs Directorate, Health Products and Food Branch, Health Canada, 11 Holland Avenue, Address Locator 3000A, Ottawa, Ontario K1A 0K9, (613) 954-5661 (telephone), (613) 954-5694 (facsimile), Diane_Kirkpatrick@hc-sc.gc.ca (electronic mail). Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1346 — Maximum Residue Limits for Veterinary Drugs). Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Diane Kirkpatrick, Director General, Veterinary Drugs Directorate, Department of Health, Address Locator 3000A, 11 Holland Avenue, Ottawa, Ontario K1A 0K9 (tel.: (613) 954-5661; fax: (613) 954-5694; e-mail: diane_Kirkpatrick@hc- sc.gc.ca). Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act. Ottawa, May 3, 2004
EILEEN BOYD
REGULATIONS AMENDING THE FOOD AND DRUG 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:
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:
3. Table III to Division 15 of Part B of the Regulations is amended by adding the following after item P.1:
4. Table III to Division 15 of Part B of the Regulations is amended by adding the following before item T.1:
COMING INTO FORCE 5. These Regulations come into force on the day on which they are registered. [19-1-o] S.C. 1999, c. 33, s. 347 C.R.C., c. 870 |
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