Proposal to amend the List of Maximum Residue Limits (MRLs) for veterinary drugs in foods - Proposed MRL 2013-1

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Date: June 4, 2013
Project Number: Proposed MRL 2013-1
Description: Proposed MRLs for veterinary drugs in foods

Notice is hereby given that the Director General, Veterinary Drugs Directorate, Health Canada, on behalf of the Minister of Health, pursuant to sections 30.3(1) to 30.5(1) of the Food and Drugs Act, proposes to amend the List of Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods. These proposed MRLs for veterinary drugs in foods, referenced below, are approved for public consultation as part of the  Marketing Authorization for Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods.

These proposed MRLs were previously published on the Health Canada website as administrative MRLs, but have not yet gone through regulatory promulgation. Residue compliance for the proposed MRLs has been monitored and confirmed by the Canadian Food Inspection Agency (CFIA).

Interested persons may make representations with respect to the proposed MRLs within 75 days after the date of publication of this notice. All such representations must cite this document and the date of publication of this notice, and be addressed to the undersigned.

To comply with Canada's international trade obligations, consultation on the proposed MRLs is also being conducted internationally by notifying the World Trade Organization.

After the period of consultation is complete, and the issues noted in the consultation have been appropriately addressed by Health Canada, the proposed MRLs will be included in the List of Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods with a Final Notice to Amend the List of MRLs for Veterinary Drugs in Foods and the effective implementation date.

Daniel Chaput
Director General

Veterinary Drugs Directorate
Health Products and Foods Branch, Health Canada
Holland Cross Complex
11 Holland Avenue
Ground Floor, Suite 14
Ottawa, Ontario K1A 0K9
Fax: 613-954-5694
E-mail: consultationVDD-DMV@hc-sc.gc.ca

I. Proposed Maximum Residue Limits (MRLs)

The List will be amended by inserting MRLs for the veterinary drugs (new entries) listed below:

Proposed MRLs - new entries
Column I
Veterinary Drug
Column II
Name of the Substance for Drug Analysis Purposes
Column III
Foods
Column IV
Maximum Residue Limits p.p.m.
Amoxicillin Amoxicillin Kidney of chickens 0.01
Liver of chickens 0.01
Muscle of chickens 0.01
Skin and fat of chickens 0.01
Kidney of swine 0.01
Liver of swine 0.01
Muscle of swine 0.01
Skin and fat of swine 0.01
Bacitracin Bacitracin A Kidney of chickens 0.5
Liver of chickens 0.5
Muscle of chickens 0.5
Skin and fat of chickens 0.5
Kidney of swine 0.5
Liver of swine 0.5
Muscle of swine 0.5
Skin and fat of swine 0.5
Kidney of turkeys 0.5
Liver of turkeys 0.5
Muscle of turkeys 0.5
Skin and fat of turkeys 0.5
Cloxacillin Cloxacillin Fat of cattle 0.01
Kidney of cattle 0.01
Liver of cattle 0.01
Muscle of cattle 0.01
Dichlorvos Dichlorvos Kidney of swine 0.05
Liver of swine 0.05
Muscle of swine 0.05
Skin and fat of swine 0.05
Emamectin Emamectin B1a free base Muscle of salmonids 0.1
Skin of salmonids 1.0
Gamithromycin Gamithromycin Fat of cattle 0.02
Kidney of cattle 0.1
Liver of cattle 0.2
Muscle of cattle 0.02
Meloxicam Meloxicam Kidney of cattle 0.2
Liver of cattle 0.06
Muscle of cattle 0.02
Ormetoprim Ormetoprim Muscle and skin of salmonids in natural proportions 0.1
Toltrazuril Toltrazuril-sulfone Kidney of swine 0.5
Liver of swine 0.7
Muscle of swine 0.1
Skin and fat of swine 0.15
Tricaine methanesulfonate Tricaine methanesulfonate Muscle and skin of salmonids in natural proportions 0.01
Tulathromycin CP-60,300 Kidney of cattle 4.0 - expressed as tulathromycin equivalent
Liver of cattle 2.0 - expressed as tulathromycin equivalent
Muscle of cattle 1.0 - expressed as tulathromycin equivalent
Kidney of swine 5.0 - expressed as tulathromycin equivalent
Liver of swine 4.0 - expressed as tulathromycin equivalent
Muscle of swine 1.5 - expressed as tulathromycin equivalent
Zilpaterol Zilpaterol free base Kidney of cattle 0.005
Liver of cattle 0.005
Muscle of cattle 0.002

II. Proposed Maximum Residue Limits (MRLs)

The List will be amended by replacing the MRLs for the veterinary drugs (existing entries) listed below by the following MRLs:

Proposed MRLs - revisions to existing entries
Column I
Veterinary Drug
Column II
Name of the Substance
for Drug Analysis Purposes
Column III
Foods
Column IV
Maximum Residue Limits p.p.m.
Albendazole Albendazole
2-aminosulfone
Fat of cattle 0.1
Kidney of cattle 0.5
Liver of cattle 0.2
Muscle of cattle 0.05
Amprolium Amprolium Fat of cattle 2.0
Kidney of cattle 0.5
Liver of cattle 0.5
Muscle of cattle 0.5
Kidney of chickens 1.0
Liver of chickens 1.0
Muscle of chickens 0.5
Kidney of turkeys 1.0
Liver of turkeys 1.0
Muscle of turkeys 0.5
Eggs 7.0
Chlortetracycline Chlortetracycline Kidney of cattle 1.2
Liver of cattle 0.6
Muscle of cattle 0.2
Kidney of chickens 1.2
Liver of chickens 0.6
Muscle of chickens 0.2
Kidney of sheep 1.2
Liver of sheep 0.6
Muscle of sheep 0.2
Kidney of swine 1.2
Liver of swine 0.6
Muscle of swine 0.2
Kidney of turkeys 1.2
Liver of turkeys 0.6
Muscle of turkeys 0.2
Eggs 0.4
Milk of cattle 0.1
Dihydrostreptomycin Dihydrostreptomycin Fat of cattle 0.5
Kidney of cattle 2.0
Liver of cattle 0.5
Muscle of cattle 0.5
Kidney of swine 2.0
Liver of swine 0.5
Muscle of swine 0.5
Skin and fat of swine 0.5
Milk of cattle 0.125
Dinitolmide (Zoalene) Dinitolmide, including the metabolite
3-amino-5-nitro-o-toluamide
Kidney of chickens 6.0
Liver of chickens 6.0
Muscle of chickens 3.0
Skin and fat of chickens 2.0
Liver of turkeys 3.0
Muscle of turkeys 3.0
Kidney of turkeys 6.0
Skin and fat of turkeys 3.0
Doramectin Doramectin Fat of cattle 0.18
Kidney of cattle 0.12
Liver of cattle 0.07
Muscle of cattle 0.03
Kidney of swine 0.07
Liver of swine 0.035
Muscle of swine 0.01
Skin and fat of swine 0.12
Erythromycin Erythromycin Fat of cattle 0.1
Kidney of cattle 0.1
Liver of cattle 0.1
Muscle of cattle 0.1
Kidney of chickens 0.125
Liver of chickens 0.125
Muscle of chickens 0.125
Skin and fat of chickens 0.125
Fat of sheep 0.2
Kidney of sheep 0.2
Liver of sheep 0.2
Muscle of sheep 0.2
Kidney of swine 0.1
Liver of swine 0.1
Muscle of swine 0.1
Skin and fat of swine 0.1
Kidney of turkeys 0.125
Liver of turkeys 0.125
Muscle of turkeys 0.125
Skin and fat of turkeys 0.125
Milk of cattle 0.05
Fenbendazole Fenbendazole Fat of cattle 0.2
Kidney of cattle 0.2
Liver of cattle 0.45
Muscle of cattle 0.1
Kidney of swine 2.0
Muscle of swine 1.0
Liver of swine 4.5
Skin and fat of swine 1.0
Fendendazole sulfoxide Milk of cattle 0.6
Flunixin Flunixin free acid Fat of cattle 0.09
Kidney of cattle 0.03
Liver of cattle 0.08
Muscle of cattle 0.02
Kidney of swine 0.03
Liver of swine 0.03
Muscle of swine 0.02
Skin and fat of swine 0.04
5-Hydroxy Flunixin Milk of cattle 0.006
Gentamicin Gentamicin Fat of cattle 0.1
Kidney of cattle 1.0
Liver of cattle 0.5
Muscle of cattle 0.1
Kidney of chickens 0.1
Liver of chickens 0.1
Muscle of chickens 0.1
Skin and fat of chickens 0.1
Kidney of swine 0.4
Liver of swine 0.3
Muscle of swine 0.1
Skin and fat of swine 0.1
Kidney of turkeys 0.1
Liver of turkeys 0.1
Muscle of turkeys 0.1
Skin and fat of turkeys 0.1
Milk of cattle 0.1
Ivermectin 22, 23-dihydro-avermectin B1a Fat of cattle 0.1
Kidney of cattle 0.14
Liver of cattle 0.07
Muscle of cattle 0.01
Fat of sheep 0.12
Kidney of sheep 0.18
Liver of sheep 0.03
Muscle of sheep 0.01
Fat of swine 0.1
Kidney of swine 0.15
Liver of swine 0.015
Muscle of swine 0.01
Moxidectin Moxidectin Fat of cattle 0.55
Kidney of cattle 0.4
Liver of cattle 0.15
Muscle of cattle 0.05
Milk of cattle 0.04
Neomycin Neomycin Fat of cattle 0.5
Kidney of cattle 10.0
Liver of cattle 0.5
Muscle of cattle 0.5
Kidney of chickens 10.0
Liver of chickens 0.5
Muscle of chickens 0.5
Skin and fat of chickens 0.5
Kidney of ducks 10.0
Liver of ducks 0.5
Muscle of ducks 0.5
Skin and fat of ducks 0.5
Fat of goats 0.5
Kidney of goats 10.0
Liver of goats 0.5
Muscle of goats 0.5
Fat of sheep 0.5
Kidney of sheep 10.0
Liver of sheep 0.5
Muscle of sheep 0.5
Kidney of swine 10.0
Liver of swine 0.5
Muscle of swine 0.5
Skin and fat of swine 0.5
Kidney of turkeys 10.0
Liver of turkeys 0.5
Muscle of turkeys 0.5
Skin and fat of turkeys 0.5
Eggs 0.5
Milk of cattle 1.5
Novobiocin Novobiocin Fat of cattle 1.0
Kidney of cattle 1.0
Liver of cattle 1.0
Muscle of cattle 1.0
Kidney of chickens 1.0
Liver of chickens 1.0
Muscle of chickens 1.0
Skin and fat of chickens 1.0
Kidney of turkeys 1.0
Liver of turkeys 1.0
Muscle of turkeys 1.0
Skin and fat of turkeys 1.0
Milk of cattle 0.1
Oxytetracycline Oxytetracycline Kidney of cattle 1.2
Liver of cattle 0.6
Muscle of cattle 0.2
Kidney of chickens 1.2
Liver of chickens 0.6
Muscle of chickens 0.2
Muscle of lobsters 0.2
Muscle of salmonids 0.2
Kidney of sheep 1.2
Liver of sheep 0.6
Muscle of sheep 0.2
Kidney of swine 1.2
Liver of swine 0.6
Muscle of swine 0.2
Kidney of turkeys 1.2
Liver of turkeys 0.6
Muscle of turkeys 0.2
Eggs 0.4
Honey 0.3
Milk of cattle 0.1
Penicillin G Penicillin G Fat of cattle 0.05
Kidney of cattle 0.05
Liver of cattle 0.05
Muscle of cattle 0.05
Kidney of chickens 0.05
Liver of chickens 0.05
Muscle of chickens 0.05
Skin and fat of chickens 0.05
Fat of sheep 0.05
Kidney of sheep 0.05
Liver of sheep 0.05
Muscle of sheep 0.05
Kidney of swine 0.05
Liver of swine 0.05
Muscle of swine 0.05
Skin and fat of swine 0.05
Kidney of turkeys 0.01
Liver of turkeys 0.01
Muscle of turkeys 0.01
Skin and fat of turkeys 0.01
Eggs 0.05
Milk of cattle 0.01 I.U./mL
Streptomycin Streptomycin Fat of cattle 0.5
Kidney of cattle 2.0
Liver of cattle 0.5
Muscle of cattle 0.5
Kidney of chickens 2.0
Liver of chickens 0.5
Muscle of chickens 0.5
Skin and fat of chickens 0.5
Kidney of swine 2.0
Liver of swine 0.5
Muscle of swine 0.5
Skin and fat of swine 0.5
Kidney of turkeys 2.0
Liver of turkeys 0.5
Muscle of turkeys 0.5
Skin and fat of turkeys 0.5
Milk of cattle 0.125
Tetracycline Tetracycline Kidney of cattle 1.2
Liver of cattle 0.6
Muscle of cattle 0.2
Kidney of chickens 1.2
Liver of chickens 0.6
Muscle of chickens 0.2
Kidney of sheep 1.2
Liver of sheep 0.6
Muscle of sheep 0.2
Kidney of swine 1.2
Liver of swine 0.6
Muscle of swine 0.2
Kidney of turkeys 1.2
Liver of turkeys 0.6
Muscle of turkeys 0.2
Milk of cattle 0.1
Tilmicosin Tilmicosin Liver of cattle 1.0
Muscle of cattle 0.1
Liver of sheep 1.0
Muscle of sheep 0.1
Liver of swine 1.5
Muscle of swine 0.1

Summary of Maximum Residue Limit (MRL) Scientific Assessment

Context

Under the Canadian Food and Drug Regulations all veterinary drugs must be authorized by Health Canada prior to their sale and administration to prevent and treat diseases, or as a production aid, 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. When a drug is approved for use in a food-producing animal, residues of drugs could remain in tissues or products of treated animals. Health Canada sets acceptable limits of residues of veterinary drugs in food commodities 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 or products of food-producing animals as a result of the treatment of those animals with veterinary drugs, which are recognized as safe by Health Canada. 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.

According to sections 30.3(1) and 30.5(1) of the Food and Drugs Act, the Minister of Health publishes the List of Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods on the Health Canada website through incorporation by reference. The proposed amendment establishes safe limits for residues of various 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. The amendments would permit the regulated sale of food containing residues of veterinary drugs up to the specified levels (MRLs) as a result of use of these drugs in food-producing animals. These amendments benefit both industry and the consumer by reducing potential losses in production, increasing quality of products, improving availability of certain foods, and supporting the trade of safe and high quality products derived from animals.

In order to determine MRLs, scientists at Health Canada conduct extensive reviews on the toxicity, metabolism and residue depletion data submitted by manufacturers, assess the risks and benefits of the 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 sufficient evidence to demonstrate that the residues found will not pose undue risks to consumers can the drug be permitted for administration to food-producing animals and the related food products sold in Canada. The MRLs apply to foods produced domestically or imported into Canada.

Scientific Rationale

Extensive toxicological (such as acute and chronic toxicity, reproduction toxicity, teratogenicity and mutagenic or carcinogenic effects) and microbiological studies (where applicable) provided by the drug manufacturers and also information from international scientific bodies were evaluated in order to establish the no or lowest-observed-effect-level (NOEL or LOEL) for each drug entity with respect to the most sensitive parameter in the most appropriate sensitive test species, or in some cases, in humans. A safety factor is then applied to take into account the inherent uncertainties in extrapolating toxicity data from animals to humans, as well as the variations within the human population to determine the acceptable daily intake (ADI) on which subsequently MRLs are based. Also, data from pharmacokinetics, metabolism and residue depletion studies provided by the drug sponsors as well as relevant information available from the recognized jurisdictions were evaluated using the principles of risk analysis to establish the proposed MRLs. In light of this information Health Canada's scientists have determined that the food commodities containing residues at levels up to the MRLs listed in the amendments are safe for human consumption.

Other considerations

It is not anticipated that the MRLs listed in the proposed amendments would have an impact on Canada's international trade activities because many of them are harmonized, where possible, or comparable with those established by Canada's major trading partners such as the United States. In addition, in many cases the proposed amendments include MRLs that are harmonized with levels established by the Joint Food and Agriculture Organization of the United Nations/World Health Organization Food Standards Programme - Codex Alimentarius Commission.

Complete harmonization with trading partners or international organizations is desirable, although it may not always be possible for various reasons (e.g., differences in food consumption patterns, regulatory requirements, testing methodologies, climate, and animal husbandry practices). Greater harmonization of food standards continues to be a priority for Health Canada and MRLs will be harmonized with those of our trading partners or Codex whenever possible provided that there are no health and safety concerns.

Implementation, enforcement and service standards

The CFIA enforces compliance with the MRLs published in the List of Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods. Compliance is monitored by the 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 food-producing animals intended for human consumption, the product will be considered "adulterated" in accordance with sections 4(a) and 4(d) 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.

The implementation date for the proposed MRLs will be announced at a later date, but will not be less than 6 months from the date of this publication.

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