Health Canada declined an on-camera interview with Marketplace for this story. Instead, they insisted on replying to our questions via email. Below are their responses to our questions about Canadian regulations for antibiotic use in food animals:
Q: What kind of regulatory oversight does Health Canada have for monitoring antibiotic use in food animal production in Canada?
A: The Federal Food and Drugs Act and Regulations address matters pertaining to the approval for sale and advertisement of drug products in Canada. Accordingly, the Veterinary Drugs Directorate (VDD) of Health Canada is responsible for evaluating and monitoring the safety, quality, and effectiveness of veterinary drugs in addition to setting standards and promoting the prudent use of drugs administered to food-producing and companion animals.
The use of drugs in animals falls under the practice of veterinary medicine, and is regulated by provincial jurisdictions.
Through its Pharmacovigilance program, VDD monitors the safety and effectiveness for all types of veterinary drugs administered to animals in Canada. This adverse drug reaction reporting system provides post-market safety surveillance to improve the monitoring of the use of veterinary drugs in Canada. It is also a source of valuable data for consideration in drug reviews.
Q: Are there quotas set for antibiotic use in farm animal production — by sector? If so, who sets these quotas?
A: No. Health Canada is not aware of any quota system for antibiotic use in farm animal production in Canada. Health Canada during the review of a product will do a critical assessment of the information on the product label. As such, the dosage prescribed for the treatment of disease, and conditions stated on the labels, are well defined. The labels will explain how the product can be used in a safe and effective manner. The overall amount of a product used will, to a large extent, depend on the number of animals to be treated.
Q: Is the industry required to report amounts of antibiotics used? How?
A: Currently, the Food and Drugs Act and Regulations do not specify requirements for the industry to report the amount of drugs sold/used.
Q: What regulatory power does Health Canada have for approval of antibiotics for use in animal agriculture?
A: Canada’s Food and Drugs Act and Regulations, gives Health Canada the authority to regulate the sale of veterinary drug products including antibiotics for use in animals including livestock.
In accordance with the Regulations, before any new veterinary drug, such as a new antibiotic, is approved for sale in Canada, Health Canada’s Veterinary Drugs Directorate (VDD) must be satisfied that the drug meets quality, efficacy and safety standards, which include:
that the drug is manufactured according to strict specifications and must remain stable up to its expiry date;
that the drug is effective for the purpose it is being marketed as well as that the drug is safe for the animals to be treated and;
that the drug does not pose health hazard to humans, including no potentially harmful residues that could pose any health hazard to humans consuming food products from treated animals (meat and milk) or no undue adverse impact on human health through antibiotic resistance.
In particular, VDD’s human safety pre-market evaluation of antibiotics includes the establishment of the withdrawal periods for antibiotics in livestock and the maximum drug residue limits in edible tissues of livestock as well as the microbiological safety assessment, which includes an antibiotic resistance risk assessment.
The labels of veterinary antibiotic products in Canada, when necessary, include warning statements concerning antibiotic resistance. Overall, as part of the comprehensive review of veterinary drugs, the VDD makes recommendations on the label in terms of conditions of use for a veterinary drug. This may include restricting access to the drug by only allowing the sale of the drug by prescription through a licensed veterinarian, defining conditions under which such drugs should be used.
After the approval of the sale of antimicrobials, Health Canada continues to monitor the post-market drug product safety through the pharmacovigilance program. The Canadian Food Inspection Agency (CFIA) regularly monitors the veterinary drug residues in edible tissues of livestock and, if necessary, takes appropriate enforcement actions. The VDD carries out human health risk assessments and provides recommendations with respect to veterinary drug residues in food products. In addition, the Public Health Agency of Canada, via the Canadian Integrated Program for Antimicrobial Resistance Surveillance (CIPARS), monitors the antibiotic resistance trends in foodborne bacteria derived from livestock. Taken together, the Canadian government has established appropriate mechanisms to ensure that veterinary antibiotic products, when administered to animals, are safe in the food chain.
Q: PHAC through its CIPARS program conducts surveillance of antibiotic resistant bacteria in retail meat. How does Health Canada respond to (or use) CIPARS data?
A: Health Canada uses an evidence based approach in making decisions, including those related to food safety.
Data generated by the Canadian Integrated Program for Antimicrobial Resistance Surveillance (CIPARS) program has helped Health Canada scientists in assessing the safety of foods of animal origin, including the regulation of veterinary drugs in food producing animals. CIPARS data has been regularly applied since 2004 by the Veterinary Drugs Directorate for pre-market human safety assessment for all new submissions of antimicrobial drug products.
CIPARS data have also been used in post-market safety assessments of certain antimicrobials as well as in the antimicrobial resistance risk assessment of veterinary antimicrobials (both pre- and post-market). CIPARS data provides information on trends in resistance development, and helps identify the risk factors that may be important for risk management decisions.
Various risk management recommendations for the use of veterinary antimicrobials in food producing animals in recent years has always considered the evidence provided by CIPARS data, examples of which include:
• Defining conditions of use on the approved label of certain drugs (two examples: extra-label use restriction on labels of fluoroquinolone, and third and fourth generation cephalosporin antimicrobials; and restriction on the use of fluoroquinolones only as a second line treatment);
• Defining conditions which should be met for certain uses of antimicrobials (two examples: use for on-arrival treatment of cattle for bovine respiratory disease is only permitted when the high risk conditions of development of disease are met (e.g., macrolides, amphenicols etc.); antimicrobials are only to be used on farms where the clinical experience and the laboratory sensitivity testing indicate the antimicrobial is likely be effective (e.g., amonxicillin, penicillin, fluoroquinolones etc.)); and
• Updating the labels (warning statements) of previously approved drugs (post-market changes). For example, restriction on extra-label use of fluoroquinolones and cephalosporins approved in companion animals.