Vol. 136, No. 4 — February 13, 2002

Its content is very similar except for the footnotes, the symbols and the tables

Registration SOR/2002-52 31 January, 2002

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1173 — Maximum Residue Limits for Veterinary Drugs)

P.C. 2002-86 31 January, 2002

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 (1173 — Maximum Residue Limits for Veterinary Drugs).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1173 — 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 A.1:

Item No.	Column I	Column II	Column III	Column IV
	Common Name (or Brand Name) of Drug	Name of Substance for Drug Analysis Purposes	Maximum Residue Limit p.p.m.	Foods
A.01	albendazole	albendazole-2-aminosulfone	0.2	Liver of cattle

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

Item No.	Column I	Column II	Column III	Column IV
	Common Name (or Brand Name) of Drug	Name of Substance for Drug Analysis Purposes	Maximum Residue Limit p.p.m.	Foods
F.1	fenbendazole	fenbendazole	0.45 4.5	Liver of cattle Liver of swine
F.2	florfenicol	florfenicol amine	0.8 2	Muscle of salmonids Liver of cattle

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

Item No.	Column I	Column II	Column III	Column IV
	Common Name (or Brand Name) of Drug	Name of Substance for Drug Analysis Purposes	Maximum Residue Limit p.p.m.	Foods
H.01	halofuginone	halofuginone	0.1	Liver of chicken

4. The portion of item I.1 of Table III to Division 15 of Part B of the Regulations in columns III (see footnote 2)  and IV (see footnote 3)  is replaced by the following:

Item No.	Column III	Column IV
	Maximum Residue Limit p.p.m	Foods
I.1	0.015 0.03 0.07	Liver of swine Liver of sheep Liver of cattle

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

Item No.	Column I	Column II	Column III	Column IV
	Common Name (or Brand Name) of Drug	Name of Substance for Drug Analysis Purposes	Maximum Residue Limit p.p.m.	Foods
L.01	lasalocid	lasalocid	0.35 0.65	Fat and skin of chicken Liver of cattle

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

Item No.	Column I	Column II	Column III	Column IV
	Common Name (or Brand Name) of Drug	Name of Substance for Drug Analysis Purposes	Maximum Residue Limit p.p.m.	Foods
M.01	maduramicin	maduramicin	0.4	Fat and skin of chicken

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

Item No.	Column I	Column II	Column III	Column IV
	Common Name (or Brand Name) of Drug	Name of Substance for Drug Analysis Purposes	Maximum Residue Limit p.p.m.	Foods
M.2	morantel tartrate	N-methyl-1,3-propane diamine	0.1 0.5	Milk Liver of cattle
M.3	moxidectin	moxidectin	0.55	Fat of cattle
N.01	narasin	narasin	0.5	Fat of chicken

8. The portion of item P.1 of Table III to Division 15 of Part B of the Regulations in column IV (see footnote 4)  is replaced by the following:

Item No.	Column IV
	Foods
P.1	Milk Edible tissue of turkeys Edible tissue of cattle and swine

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

Item No.	Column I	Column II	Column III	Column IV
	Common Name (or Brand Name) of Drug	Name of Substance for Drug Analysis Purposes	Maximum Residue Limit p.p.m.	Foods
S.01	salinomycin	salinomycin	0.35	Fat and skin of chicken; Liver of cattle and swine

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

Item No.	Column I	Column II	Column III	Column IV
	Common Name (or Brand Name) of Drug	Name of Substance for Drug Analysis Purposes	Maximum Residue Limit p.p.m.	Foods
S.3.1	sulfadiazine	sulfadiazine	0.1	Muscle of salmonids

11. The portion of item S.6 of Table III to Division 15 of Part B of the Regulations in columns III (see footnote 5)  and IV (see footnote 6)  is replaced by the following:

Item No.	Column III	Column IV
	Maximum Residue Limit p.p.m.	Foods
S.6	0.01 0.1	Milk Edible tissue of calves, cattle, chickens, swine and turkeys

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

Item No.	Column I	Column II	Column III	Column IV
	Common Name (or Brand Name) of Drug	Name of Substance for Drug Analysis Purposes	Maximum Residue Limit p.p.m.	Foods
T.3.1	tilmicosin	tilmicosin	1.6	Liver of cattle
T.3.2	trimethoprim	trimethoprim	0.1	Muscle of salmonids

COMING INTO FORCE

13. 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, 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 will establish safe limits for residues of sixteen (16) 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 levels 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 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 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 amendments are safe for consumption. These MRLs will apply to foods produced domestically or imported into Canada.

Alternatives

The addition of new MRLs for veterinary drugs to Table III in Division 15 of the Food and Drug Regulations, can only be accommodated by regulatory amendment. These amendments will list additional MRLs for specific veterinary drugs which are beneficial to the food industry and do not pose any health hazard to consumers.

Benefits and Costs

These amendments will permit the sale of food containing residues of veterinary drugs used to prevent and treat diseases in food producing animals. These amendments will 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 MRLs are harmonized with MRLs for veterinary drugs already established by Canada's major trading partners such as the United States. In addition, the amendments include MRLs that are harmonized with levels established by the Codex Alimentarius Commission and adopted by many countries.

There will not be an increased cost to government from the administration of these amendments to the Regulations. Compliance costs will not be 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, consultation was undertaken with provincial and federal health and agriculture authorities, Canadian veterinary colleges, provincial veterinary medical associations, the Canadian Veterinary Medical Association, the Dairy Farmers of Canada, the Aquaculture Association of Canada, the Canadian Feed Industry, the Canadian Chicken Marketing Agency, the Canadian Turkey Marketing Agency, the National Dairy Council of Canada, the Further Poultry Processors Association of Canada, the Canadian Cattlemen's Association, the Canadian Animal Health Institute, the Canadian Meat Council, the Fisheries Council of Canada, the Canadian Pork Council, the Canadian Poultry and Egg Processors Council, the Federal/Provincial/Territorial Committee on Food Safety Policy, the Canadian Beef Export Federation, the Canadian Food Inspection Agency, Agriculture and Agri-Food Canada, and the Department of Fisheries and Oceans.

There were twenty responses received as a result of the above consultation. The letters were generally supportive of the MRLs but they did raise several issues. Health Canada responded in writing to each of these letters addressing the issues, as indicated below, and if necessary, modified the proposed schedule accordingly, prior to pre-publication. There were no modifications to the final schedule after pre-publication.

Comments on specific MRLs proposed received before pre-publication in this schedule of amendments

A representative of the Quebec provincial government was concerned that specific proposed MRLs would have allowed antibiotic residues in milk. New legislation, pertaining to agricultural, marine and dairy products, was enacted in Quebec in the summer 2000. Further time is needed to examine this legislation to determine what impact, if any, it may have on MRLs for veterinary drug residues in milk. Accordingly, the MRLs of concern to Quebec were removed from this schedule of amendments, prior to pre-publication, to allow the other MRLs to continue through the regulatory process.

Harmonization with Trading Partners

Many of the MRLs in this schedule are harmonized, where possible, 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.

Screening Tests and Methods of Detection

An industry association expressed concerns that the increased number of MRLs for antibiotics in milk would adversely affect the suitability of screening tests used to detect antibiotics in milk. Health Canada responded that no increase in the overall residues of antibiotics in milk was anticipated as a result of the additional MRLs and accordingly the suitability of the screening tests should not be affected.

No additional comments were received as a result of the prepublication of this schedule on September 16, 2000.

Compliance and Enforcement

Compliance will be monitored by ongoing domestic and import inspection programs.

Contact

Mr. Ronald Burke

Director

Bureau of Food Regulatory,

International and Interagency Affairs

Health Canada

A.L. 0702C1

Ottawa, Ontario

K1A 0L2

Tel.: (613) 957-1828

FAX: (613) 941-3537

E-mail: sche-ann@hc-sc.gc.ca

 Footnote a 

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

 Footnote 1 

C.R.C., c. 870

 Footnote 2 

SOR/91-255

 Footnote 3 

SOR/91-255

 Footnote 4 

SOR/91-255

 Footnote 5 

SOR/91-255

 Footnote 6 

SOR/91-255

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