Proposal to amend the List of Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods - Proposed MRL 2016-2

Date: October 20 2016
Project Number: Proposed MRL 2016-2
Description: Proposed MRLs for veterinary drugs in foods - Veal

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 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.

This 75 day consultation is open for comment starting October 20, 2016 until January 2, 2017. All comments must cite this document, 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.

Mary Jane Ireland
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
E-mail: consultationVDD-DMV@hc-sc.gc.ca

I. Maximum Residue Limits (MRLs) - revisions to Column III-Foods

The Foods in Column lll listed below will be replaced by the following proposed text:

Summary of Maximum Residue Limit (MRL) Scientific Assessment for Calves to be processed for Veal

Context

Under the Canadian Food and Drug Regulations, all veterinary drugs must be authorized by Health Canada prior to their sale in Canada. 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.

Historically, some veterinary drug MRLs established in cattle have been applied to all production classes, while others have been considered not to apply to calves to be processed for veal. Given the potential human health risk associated with certain drugs, Health Canada is providing clear guidance that for most veterinary drugs, cattle MRLs can be applied to calves to be processed for veal however, there are some exceptions. This proposal identifies those veterinary drugs for which MRLs in cattle tissues are not applicable to calves to be processed for veal in the List of Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods.

Scientific Rationale

The proposed amendments to the List are based on Health Canada’s assessment that certain drugs approved for use in adult cattle should not be used in calves to be processed for veal and therefore the cattle MRLs do not apply to veal calves. These include drugs used for hormonal growth promotion, antimicrobial drugs considered to be of very high importance in human medicine (Category I), and hormonal drug premixes for growth enhancement approved for adult cattle.

Health Canada and the Canadian Food Inspection Agency (CFIA) issued a joint advisory to stakeholders in 2004 advising them that hormonal growth promoters should not be used in any type of veal production. Health Canada’s  risk assessment on Category I antimicrobials has concluded that the use of these drugs in animals in which their safety has not been assessed or in a manner different than that approved on the label could pose serious human health risks, especially through development and spread of antimicrobial resistance. Limited available data on antimicrobial resistance in veal also support this assessment. Consequently, Health Canada has recommended against the extra-label use of these drugs in animals.

Based on the conditions set out in Section C.08.012 (1)(c) of the Food and Drug Regulations (FDR), a drug premix is only permitted for therapeutic purposes even under a veterinary prescription.

Other considerations

It is not anticipated that 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.