Health Canada
Symbol of the Government of Canada

Common menu bar links

Drugs and Health Products

Proposal to amend the List of Maximum Residue Limits (MRLs) for veterinary drugs in foods - Proposed MRL 2014-1

Warning This content was archived on February 13, 2015.

Archived Content

Information identified as archived on the Web is for reference, research or recordkeeping purposes. It has not been altered or updated after the date of archiving. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats on the "Contact Us" page.

Notice to the reader: The online consultation is now closed.

Date: January 10, 2014
Project Number: Proposed MRL 2014-1
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  and the Next link will take you to another Web site Marketing Authorization for Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods proposes to amend the List of Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods. The proposed MRLs for veterinary drugs in foods, referenced below, are approved for public consultation.

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)- new MRLs

The List will be amended by inserting new MRLs listed below. The proposed MRLs may either be for a new veterinary drug (Column I), or for a new food (Column III) for an existing veterinary drug.

Proposed new MRLs
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.

Table 1 footnotes

Table 1 footnote 1

Under the approved conditions of use, the predicted levels of residues of these veterinary drugs in foods are considered unlikely to be of human safety concern, and there is no need to routinely monitor these residues to ensure consumer safety. See Frequently Asked Questions - MRLs for further information.

Return to table 1 footnote 1 referrer

Acetyl salicylic acid Not applicable Fat of cattle No MRL requiredTable 1 footnote 1
Kidney of cattle
Liver of cattle
Muscle of cattle
Altrenogest Altrenogest Muscle of swine 0.001
Skin and fat of swine 0.001
Apramycin Not applicable Liver of swine No MRL requiredTable 1 footnote 1
Muscle of swine
Skin and fat of swine
Enrofloxacin Desethylene ciprofloxacin Fat of cattle 0.02
Kidney of cattle 0.02
Enrofloxacin Kidney of swine 0.2
Liver of swine 0.2
Muscle of swine 0.1
Skin and fat of swine 0.1
Eprinomectin Eprinomectin B1a Fat of cattle 0.5
Kidney of cattle 0.3
Florfenicol Florfenicol amine Fat of cattle 0.2
Kidney of cattle 0.5
Kidney of chickens 0.75
Liver of chickens 2.0
Muscle of chickens 0.1
Skin and fat of chickens 0.2
Kidney of swine 1.0
Skin and fat of swine 0.5
Gonadotropin releasing factor analogue - protein conjugate Not applicable Kidney of swine No MRL requiredTable 1 footnote 1
Liver of swine
Muscle of swine
Skin and fat of swine
Lasalocid Lasalocid Fat of cattle 0.1
Kidney of cattle 0.2
Muscle of cattle 0.05
Kidney of chickens 0.4
Liver of chickens 0.4
Muscle of chickens 0.03
Fat of sheep 0.1
Kidney of sheep 0.2
Liver of sheep 0.8
Muscle of sheep 0.05
Kidney of turkeys 0.4
Liver of turkeys 0.4
Muscle of turkeys 0.03
Skin and fat of turkeys 0.4
Lincomycin Lincomycin Kidney of chickens 0.5
Skin and fat of chickens 0.3
Kidney of swine 1.5
Skin and fat of swine 0.3
Maduramacin Maduramacin Kidney of chickens 1.0
Liver of chickens 0.5
Muscle of chickens 0.1
Kidney of turkeys 1.0
Liver of turkeys 0.5
Muscle of turkeys 0.1
Skin and fat of turkeys 0.4
Narasin Narasin Kidney of chickens 0.05
Liver of chickens 0.05
Kidney of swine 0.05
Skin and fat of swine 0.05
Pirlimycin Pirlimycin Fat of cattle 0.1
Kidney of cattle 0.4
Semduramicin Semduramicin Kidney of chickens 0.2
Liver of chickens 0.4
Muscle of chickens 0.13
Skin and fat of chickens 0.5
Tildipirosin Tildipirosin Fat of cattle 1.0
Kidney of cattle 4.0
Liver of cattle 3.5
Muscle of cattle 0.4
Tylosin Tylosin A and B Honey 0.2 (sum of tylosin A and B, calculated as tylosin A)
Tylvalosin Tylvalosin Kidney of swine 0.05
Liver of swine 0.05
Muscle of swine 0.05
Skin and fat of swine 0.05

II. Proposed Maximum Residue Limits (MRLs)- revisions to existing MRLs

The MRLs in foods (Column III) listed below will be replaced by the following proposed MRLs:

Proposed MRLs - revisions to existing MRLs
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.
Lasalocid Lasalocid Liver of cattle 0.7
    Skin and fat of chickens 0.4
Monensin Monensin Liver of cattle 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. The MRLs apply to foods produced domestically or imported into Canada.

According to sections 30.3(1) and 30.5(1) of the Food and Drugs Act, and the Next link will take you to another Web site Marketing Authorization for Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods, 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. 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.

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 proposed 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 while ensuring 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. 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.