Vol. 141, No. 17 — April 28, 2007

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

Statutory authority

Food and Drugs Act

Sponsoring department

Department of Health

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. Amendments to the Regulations are proposed to promulgate safe limits for residues of ten 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 (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.

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 product 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 proposed amendments are safe for consumption. These MRLs would apply to foods produced domestically or imported into Canada.

There are a number of authorized veterinary drugs for use in food producing animals with MRLs already established and listed in Table III to Division 15 of Part B of the Regulations. In the past, MRLs were not always established when a veterinary drug was authorized for sale in Canada. Further, the regulatory process could take up to two years to promulgate an MRL, which could only be done after an Notice of Compliance (NOC) had been issued. Where residues of the authorized drugs were found in food products, in the absence of an MRL listed in the Regulations, a zero tolerance policy was exercised and appropriate compliance action was taken. This situation was creating difficulties and costly delays for the producer sector and, importantly, was not contributing to enhancing public health.

A joint Health Canada and Canadian Food Inspection Agency (CFIA) policy regarding the use of Administrative MRLs (AMRLs) was established in 2002 as a mechanism for applying enforceable limits for authorized drugs prior to their promulgation in regulations. In 2004, to further help address this situation, the Veterinary Drugs Directorate (VDD) of Health Canada made a commitment to establish MRLs with every NOC for food producing animal drugs. MRLs and AMRLs enhance health protection by identifying and measuring the risks of veterinary drug residues to the health of consumers, and, as a result, the appropriate action can be taken to protect Canadians from those risks. AMRLs are scientifically equivalent to MRLs, that is, they result from the scientific evaluation process, they differ only in that they are not yet promulgated. Once the regulatory process is complete, the AMRL is promulgated as an MRL.

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 proposed amendments would list new MRLs for diclazuril, doramectin, enrofloxacin, eprinomectin, flunixin, ketoprofen, lincomycin, monensin, narasin and oxytetracycline.

CFIA is responsible for the enforcement of the MRLs set in Table III to Division 15 of the Regulations. Where no MRL exists in the Regulations, rather than having to enforce a zero tolerance policy, CFIA can take AMRLs into consideration as part of their monitoring and compliance program. The condition is that the AMRLs are in the public domain and listed on VDD's Web site. By adopting the use of AMRLs, CFIA is better equipped to focus the risk-based enforcement of efforts regarding these veterinary drugs and thus make a greater contribution to ensuring the safety of food in the Canadian marketplace. In the case where no MRL or AMRL exists, there will continue to be case-by-case assessments. For more information, refer to VDD's Web site for AMRLs and MRLs that are currently in the legislative process: www.hc-sc.gc.ca/dhp-mps/vet/mrl-lmr/mrl-lmr_versus_new-nouveau_e.html.

Benefits and costs

The proposed amendments would 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 proposed amendments would benefit both industry and the consumer by reducing potential losses in production, increasing quality of products and improving availability of certain foods.

A number of the proposed MRLs are harmonized with MRLs for veterinary drugs already established by Canada's major trading partners such as the United States. In addition, the proposed 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 proposed amendments to the Regulations. Compliance costs would not be a factor, because 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 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), British Columbia 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, BC 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, PEI Dairy Producers Association, BC Milk Marketing Board, Alberta Dairy Control Board, Saskatchewan Milk Control Board, Dairy Farmers of New Brunswick, 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, BC 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, PEI Dairy Producers Association, BC Milk Marketing Board, Alberta Dairy Control Board, Saskatchewan Milk Control Board, Dairy Farmers of New Brunswick, 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, 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, BC 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, PEI Dairy Producers Association, BC Milk Marketing Board, Alberta Dairy Control Board, Saskatchewan Milk Control Board, Dairy Farmers of New Brunswick, 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, 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, BC 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, PEI Dairy Producers Association, Fisheries Council of Canada, Aquaculture Association of Canada, Salmon Health Consortium, Aquaculture Association of Nova Scotia, BC Salmon Farmers Association, New Brunswick Salmon Growers Association, Newfoundland Aquaculture Industry Association, Ontario Aquaculture Association, Further Poultry Processors Association of Canada, Canadian Poultry and Egg Processors Council, Chicken Farmers of Canada, Canadian Turkey Marketing Agency, Canadian Egg Marketing Agency, Canadian Honey Council, Canadian Association of Professional Apiculturists, BC Milk Marketing Board, Alberta Dairy Control Board, Saskatchewan Milk Control Board, Dairy Farmers of New Brunswick, Prince Edward Island Milk Marketing Board, APA 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 of detection (1), adjustment of withdrawal times (1), requests for additional MRLs (2).

Comments on specific MRLs proposed 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 proposed MRLs with those of Canada's major trading partners. It is not anticipated that the proposed 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. Complete harmonization with trading partners or international organizations is desirable, but will not occur until countries start conducting joint reviews of scientific data. 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 the proposed 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.

Compliance and enforcement

Compliance is monitored by ongoing domestic and import inspection programs conducted by the CFIA. If levels of drug residues in excess of these limits are found in food products derived from animals intended for human consumption, 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 it finds violative residues. The CFIA's regulatory activities help to maintain consumer and market confidence in Canada's food supply.

Contact

Siddika Mithani, Director General, Veterinary Drugs Directorate, Health Products and Food Branch, Health Canada, 11 Holland Avenue, Address Locator 3000A, Ottawa, Ontario K1A 0K9, 613-954-5694 (fax), vetdrugs-medsvet@hc-sc.gc.ca (email).

PROPOSED REGULATORY TEXT

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 (1437 — 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 Dr. Siddika Mithani, Director General, Veterinary Drugs Directorate, Department of Health, Holland Cross Complex, Suite 14, Address Locator 3000A, 11 Holland Avenue, Ottawa, Ontario K1A 0K9 (fax: 613-954-5694; e-mail: vetdrugs-medsvet@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, April 19, 2007

MARY O'NEILL
Assistant Clerk of the Privy Council

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:

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

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

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

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

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:

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:

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

COMING INTO FORCE

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

[17-1-o]

Footnote a

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

Footnote 1

C.R.C., c. 870

NOTICE:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with hypertext language (HTML). Its content is very similar except for the footnotes, the symbols and the tables.

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