Registration

SOR/2008-274 September 5, 2008

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1437 — Maximum Residue Limits for Veterinary Drugs)

P.C. 2008-1660 September 5, 2008

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 (see footnote b), hereby makes the annexed Regulations Amending the Food and Drug Regulations (1437 — Maximum Residue Limits for Veterinary Drugs).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1437 — 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 after item D.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
D.1.1	diclazuril	diclazuril	0.5	Muscle of chickens and turkeys
			1.0	Skin and fat of chickens and turkeys
			3.0	Liver of chickens and turkeys

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

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
D.4	doramectin	doramectin	0.01	Muscle of swine
			0.03	Muscle of cattle
			0.035	Liver of swine
			0.07	Liver of cattle
E.01	enrofloxacin	desethylene ciprofloxacin	0.02	Muscle of cattle
			0.07	Liver of cattle
E.02	eprinomectin	eprinomectin B1a	0.02	Milk
			0.1	Muscle of cattle
			1.0	Liver of cattle

3. Table III to Division 15 of Part B of the Regulations is amended by adding the following after item F.2:

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
F.3	flunixin	flunixin free acid	0.02	Muscle of cattle
			0.08	Liver of cattle

4. Table III to Division 15 of Part B of the Regulations is amended by adding the following after item I.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
K.1	ketoprofen	ketoprofen	0.05	Milk
			0.1	Muscle of swine
			0.25	Muscle of cattle
			0.5	Kidney of swine
			0.8	Kidney of cattle

5. Table III to Division 15 of Part B of the Regulations is amended by adding the following after item L.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
L.2	lincomycin	lincomycin	0.1	Muscle of chickens and swine
			0.5	Liver of chickens and swine

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

Item No.	Column III Maximum Residue Limit p.p.m.	Column IV Foods
M.1	0.01	Milk
	0.05	Edible tissue of cattle, chickens and turkeys

7. The portion of item N.01 of Table III to Division 15 of Part B of the Regulations in columns III and IV is replaced by the following:

Item No.	Column III Maximum Residue Limit p.p.m.	Column IV Foods
N.01	0.05	Muscle of chickens and swine; liver of swine
	0.5	Fat of chickens

8.Table III to Division 15 of Part B of the Regulations is amended by adding the following after item N.4:

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
O.1	oxytetracycline	oxytetracycline	0.2	Muscle of cattle, chickens, lobster, salmonids, sheep, swine and turkeys
			0.3	Honey
			0.4	Eggs
			0.6	Liver of cattle, chickens, sheep, swine and turkeys
			1.2	Kidneys of cattle, chickens, sheep, swine and turkeys; fat of cattle and sheep; skin and fat of chicken, swine, and turkeys

COMING INTO FORCE

9. 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 Canadian Food and Drug Regulations (the Regulations), all veterinary drugs must be authorized 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 10 veterinary drugs 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.

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 the specific veterinary drugs 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. There are a number of MRLs already established in Table III to Division 15 of Part B of the Regulations.

Alternatives

The addition of new MRLs for veterinary drugs to Table III to Division 15 of the Regulations can only be accommodated by regulatory amendment. These amendments list new MRLs for diclazuril, doramectin, enrofloxacin, eprinomectin, flunixin, ketoprofen, lincomycin, monensin, narasin and oxytetracycline.

Benefits and c osts

The amendments permit the regulated 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 the quality of products and improving the availability of certain foods.

A number of these MRLs are harmonized with MRLs for veterinary drugs already established by Canada’s major trading partners such as the United States. In addition, these amendments 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 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 amendments were conducted individually. The following groups were consulted on all the amendments: national and provincial veterinary associations, veterinary colleges and universities, Canadian Animal Health Institute, Canadian Pork Council, Canadian Cattlemen’s Association, Dairy Farmers of Canada, Canadian Aquaculture Industry Alliance, Animal Nutrition Association of Canada, Environmental Defence, Society for Environmentally Responsible Livestock Operation of Alberta (SERLO), BC Ministry of Agriculture, Food and Fisheries, Canadian Poultry and Egg Processors Council, Canadian Council on Animal Care, Consumers’ Association of Canada, 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 diclazuril: Further Poultry Processors Association of Canada, Chicken Farmers of Canada, Canadian Turkey Marketing Agency, Canadian Egg Marketing Agency, Poultry Industry Council, Schering-Plough Animal Health and Fisheries and Oceans Canada.

— For doramectin: Canadian Swine Breeders Association, Maple Leaf Foods Inc., Canadian Centre for Swine Improvement and Fisheries and Oceans Canada.

— For enrofloxacin: Canadian Swine Breeders Association, Maple Leaf Foods Inc., Canadian Centre for Swine Improvement, Fisheries and Oceans Canada and Bayer Inc.

— For eprinomectin: Canadian Dairy Commission, Alberta Milk, British Columbia Dairy Foundation, Canadian Federation of Agriculture, Dairy Farmers of Newfoundland and Labrador, Dairy Farmers of Nova Scotia, Dairy Farmers of Ontario, Dairy Farmers of Saskatchewan Inc., Fédération des producteurs de lait du Québec, Mainland Dairymen’s Association, Manitoba Milk Producers, Prince Edward Island Dairy Producers Association, British Columbia Milk Marketing Board, Alberta Dairy Control Board, Saskatchewan Milk Control Board, New Brunswick Milk Marketing Board, Prince Edward Island Milk Marketing Board and Merial Canada Inc.

— For flunixin: Canadian Meat Council.

— For ketoprofen: Canadian Meat Council, Canadian Dairy Commission, 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 Ontario, Dairy Farmers of Saskatchewan Inc., Fédération des producteurs de lait du Québec, Mainland Dairymen’s Association, Manitoba Milk Producers, Prince Edward Island Dairy Producers Association, British Columbia Milk Marketing Board, Alberta Dairy Control Board, Saskatchewan Milk Control Board, New Brunswick Milk Marketing Board, Prince Edward Island Milk Marketing Board and Fisheries and Oceans Canada.

— For ketoprofen in swine: Canadian Swine Breeders Association, Maple Leaf Foods Inc., Canadian Centre for Swine Improvement, Merial Canada Inc. and Fisheries and Oceans Canada.

— For lincomycin: Canadian Swine Breeders Association, Maple Leaf Foods Inc., Canadian Centre for Swine Improvement, Chicken Farmers of Canada, Poultry Industry Council of Canada, Canadian Food Inspection System Implementation Group, Canadian Animal Health Coalition, Coop fédérée du Québec, Pharmacia Division of Pfizer Canada Animal Health Group, BIO AGRI MIX 1998 Inc. and Fisheries and Oceans Canada.

— For monensin: Canadian Dairy Commission, 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 Ontario, Dairy Farmers of Saskatchewan Inc., Fédération des producteurs de lait du Québec, Mainland Dairymen’s Association, Manitoba Milk Producers, Prince Edward Island Dairy Producers Association, British Columbia Milk Marketing Board, Alberta Dairy Control Board, Saskatchewan Milk Control Board, New Brunswick Milk Marketing Board, Prince Edward Island Milk Marketing Board, Elanco Animal Health and Fisheries and Oceans Canada.

— For narasin: Further Poultry Processors Association of Canada, Chicken Farmers of Canada, Canadian Turkey Marketing Agency, Canadian Egg Marketing Agency, Poultry Industry Council of Canada, Schering-Plough Animal Health and Fisheries and Oceans Canada.

— For oxytetracycline: Canadian Meat Council, Canadian Beef Export Federation, Canadian Swine Breeders Association, Maple Leaf Foods Inc., Canadian Centre for Swine Improvement, Canadian Sheep Federation, Canadian Sheep Breeders’ Association, Canadian Dairy Commission, Alberta Milk, British Columbia Dairy Foundation, Canadian Federation of Agriculture, Dairy Farmers of Newfoundland and Labrador, Dairy Farmers of Nova Scotia, Dairy Farmers of Ontario, Dairy Farmers of Saskatchewan Inc., Fédération des producteurs de lait du Québec, Mainland Dairymen’s Association, Manitoba Milk Producers, Prince Edward Island Dairy Producers Association, Fisheries Council of Canada, Aquaculture Association of Canada, Salmon Health Consortium, Aquaculture Association of Nova Scotia, British Columbia Salmon Farmers Association, New Brunswick Salmon Growers Association, Newfoundland Aquaculture Association, Ontario Aquaculture Association, Further Poultry Processors Association of Canada, Canadian Poultry and Egg Processors Association of Canada, Chicken Farmers of Canada, Canadian Turkey Marketing Agency, Canadian Egg Marketing Agency, Canadian Honey Council, Canadian Association of Professional Apiculturalists, British Columbia Milk Marketing Board, Alberta Dairy Control Board, Saskatchewan Milk Control Board, New Brunswick Milk Marketing Board, Prince Edward Island Milk Marketing Board, A.P.A Division of Vétequinol N.A Inc., Ayerst Veterinary Laboratories, Big Country Agri-Feeds Ltd., Bimeda-MTC Animal Health Inc., BIO AGRI MIX 1998 Inc., Boehringer Ingelheim (Canada) Ltd., Citadel Animal Health, Cross Vetpharm Group Ltd., Dominion Veterinary Labatories Ltd., Interprovincial Co-op Ltd., Jaapharm Canada Inc., J.C. Bright M Ltd., Jamp Pharma Cooperation, Medivet Pharmaceuticals Ltd., Medprodex Inc., MTC Pharmaceuticals, Norbrook Laboratories Ltd., Pfizer Canada Inc., Phibro Animal Health Ltd., Unifeed Ltd., Wendt Labs and Fisheries and Oceans Canada.

There were 56 responses received as a result of the above consultations. Most of the letters were supportive of the MRLs; however, some issues were raised. The comments provided by the respondents can be summarized as follows: comments on specific MRLs (3), harmonization of specific MRLs with those of Canada’s major trading partners (11), methods for detection (1), adjustment of withdrawal times (1), requests for additional MRLs (2).

Comments on specific MRLs in this schedule of amendments were very technical in nature and responses have been sent directly to the respondents.

Harmonization with trading partners and trade implications

Eleven respondents commented on harmonization of these MRLs with those of Canada’s major trading partners. Although harmonization with other countries is a worthwhile consideration, the primary concern in establishing MRLs remains the health and safety of Canadians. It is not anticipated that these MRLs would have an impact on Canada’s activities because many of the MRLs are harmonized, where possible, with those adopted by Canada’s major trading partners. For example, when compared with the United States, seven drugs (diclazuril, dormaectin, enrofloxacin, flunixin, lincomycin, monesin and narasin) have identical or similar MRLs, one drug (ketoprofen) is not approved, and two (eprinomectin for liver, and notably oxytetracyline) are lower. Canadian MRLs for oxytretracycline were harmonised with Codex Alimentararius MRLs which are used as World Trade Organization benchmark standards in international disputes and are similar to that of other jurisdictions. The United States “tolerances” for oxytetracycline are 10 times higher than the Canadian and international standards. 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.

Methods of detection

One respondent commented that analytical methods should be developed and validated for all species/tissue pairs, and surveillance programs should include some testing of milk derived from food-producing animals, as well as sheep muscle and liver samples. The veterinary drug of interest has only been indicated for non-lactating cattle and is not authorized for use in sheep or any lactating food-producing animal. As a result, there would be a zero tolerance for residues in products derived from sheep and milk.

Adjustments of withdrawal times

One respondent inquired whether it would be possible to make changes to the established withdrawal times for the various formulations of a particular veterinary drug currently registered for use in Canada. Health Canada does not anticipate changes to the withdrawal period since these MRLs were established to ensure safety of Canada’s food supply. Scientists review the residue depletion data and determine an acceptable withdrawal period (the time between the last treatment with a veterinary drug and slaughter for human consumption) based on analysis of marker substances indicative of the total residue of the administered drug in the tissue of the animal. This withdrawal period is intended to ensure that residues, if any, in the food products originating from animals treated with these particular veterinary drugs will not pose a health hazard to the consumer.

Requests for additional MRLs

Two respondents requested additional MRLs for use of a veterinary drug in an application of interest to them. The interested parties were informed that Health Canada would conduct health risk assessments for the MRL of interest to establish and determine whether the existing withholding times vary for different food products. The assessment is based on the best scientific data available and the pattern of consumption of the foods containing the residues of the drug. If sufficient data are available to establish the safety of the suggested MRLs, they would be included in a future schedule of amendments.

These amendments were published in the Canada Gazette, Part I, on April 28, 2007, for a 75-day period. No comments were received as a result of the prepublication.

Compliance and e nforcement

Compliance is monitored by ongoing domestic and import inspection programs conducted by the Canadian Food Inspection Agency (CFIA). If levels of drug residues in excess of these limits are found in food products derived from food animals intended for human consumption such that the levels pose a risk to human health, the product will be considered “adulterated,” in accordance with section 4 of the Food and Drugs Act. The CFIA is authorized under the Food and Drugs Act to take compliance action, when they find violative residues. The CFIA’s regulatory activities help to maintain consumer and market confidence in Canada’s food supply.

Contact

Louis Boulay
Acting Director General
Veterinary Drugs Directorate
Health Products and Food Branch
Health Canada
11 Holland Avenue
Address Locator 3000A
Ottawa, Ontario
K1A 0K9
Fax: 613-957-3884
Email: vetdrugs-medsvet@hc-sc.gc.ca

Footnote a
S.C. 2005, c. 42, s. 2

Footnote b
R.S., c. F-27

Footnote 1
C.R.C., c. 870

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