Veterinary Drugs Directorate
Holland Cross Complex
Tower A, Ground Floor, Suite 14
11 Holland Avenue, A.L. 3000A
Ottawa, Ontario K1A 0K9

March 22, 2007

Subject:

Consultation on Health Canada's Proposed Aquaculture Policy - Ensuring that Safe and Effective Veterinary Drugs are Available for Use in Aquatic Animal Species: A Policy Discussion Document

Dear Stakeholder:

Health Canada's Veterinary Drugs Directorate (VDD) is posting a draft policy discussion document regarding veterinary drugs for use in aquaculture for stakeholder consultation. The purpose of this document is to obtain feedback from interested stakeholders on a proposed approach to address the lack of authorized veterinary drugs for use in aquatic species.

The document can be found at the following URL: http://www.hc-sc.gc.ca/dhp-mps/ consultation/vet/consultations/index-eng.php

I would appreciate your collaboration in bringing this information to the attention of all interested parties in your organization so as to solicit their comments.

Written feedback should be submitted by May 21, 2007, and directed to:

• Kathy Dobbin, Director
  Strategic Planning and Stakeholder Relations Division
  Veterinary Drugs Directorate
  Health Products and Food Branch, Health Canada
  Holland Cross Complex, 11 Holland Avenue, Suite 14
  Ottawa, ON K1A 0K9
  Fax: (613) 941-9345
  Email: Kathy_Dobbin@hc-sc.gc.ca

We look forward to receiving your comments.

Sincerely,

Siddika Mithani, Ph.D
Director General

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Ensuring that Safe and Effective Veterinary Drugs are Available for Use in Aquatic Animal Species: A Policy Discussion Document

1. Purpose:

The purpose of this document is to develop a course of action for Health Canada, in conjunction with interested stakeholders, to address the lack of authorized veterinary drugs for use in aquatic species.

2. Background:

The mandate of Health Canada's Veterinary Drugs Directorate (VDD) is to protect human and animal health and the safety of Canada's food supply. VDD evaluates and monitors the safety, quality and effectiveness, sets standards and promotes the prudent use of veterinary drugs administered to food-producing and companion animals.

The aquaculture industry is the fastest growing food production sector in Canada, having increased steadily from $7 million in 1984 to $558 million in 1999. The production of this sector represents over 113,000 tonnes of aquacultured fish species and about 30% of the total landed value of the Canadian fisheries sector. This industry is growing at a rate of 15-20% per annum. This trend is expected to continue, resulting in an industry worth approximately $2.8 billion by 2010. Currently, over 70 species are being commercially farmed in Canada, or are in the experimental stages of development. While salmon is the predominant species, other fish such as cod, haddock, halibut, brook and rainbow trout, tilapia, and arctic char, are also farmed. There is also rapid growth in the shellfish industry, including mussels, oysters, clams, and scallops. There are 600 identified aquaculture producers in Canada.

Intensive aquaculture is a technically complex industry which is increasing at a rate greater than the ability to collect scientific data on issues such as effects on the environment, human health and regulatory oversight. Recent public concern regarding chemical use on fish farms, including tissue residues, environmental impact and antimicrobial resistance, indicates that there are unmet needs for authorized therapeutic products for use in farming fish.

Few veterinary drugs are authorized for use in aquatic animal species, and of these most are authorized for use in salmonids. One of the major limiting factors hindering the authorization of aquaculture drugs in Canada is the access to scientific data to support safety and efficacy.

3. Key Issues:

3.1

The Canadian aquaculture industry may be at a competitive disadvantage with competing the American Aquaculture Industry by the proximity of the American market, where the existence of the Minor Use and Minor Species (MUMS) Animal Health Act (2004) has increased the availability of new therapies for animals (including aquatic animals)¹

3.2

Prior to a veterinary drug being authorized for sale in Canada by VDD, a thorough scientific evaluation is conducted which allows for the establishment of MRLs and associated Withdrawal Periods (WP). These standards reduce the risks of harmful residues that could potentially be present in food-producing animals. Few drugs have undergone this process as far as drugs for use in aquaculture is concerned, and almost all are approved only for salmonids.

3.3

The broad range of species and conditions treated in the course of a veterinarian's aquaculture practice, and the limited number of approved drugs in Canada, may pose challenges to veterinarians as far as using safe and efficacious drugs for treating their patients.

3.4

Very few drugs are approved for use in aquaculture species and there is a need to treat these several other species which are being aquacultured in Canada and for which no labelled indication are available in Canada. This situation leads to extra label use (ELDU) of drugs which are available. When unapproved drugs or approved drugs are used in an extra-label manner appropriate WPs have not been established at those levels and this may cause potential safety concerns with regards to the harmful residues being present in the food being consumed. In addition there are risks to the environment and concerns related to the issue of antimicrobial resistance

3.5

The multi-jurisdictional situation in Canada with regards to the responsibility of overlooking the sale and use of drugs may create an inconsistent approach across the country. Some provincial regulations require treatment of aquatic animals to control diseases, thus obliging veterinarians to prescribe drugs in an extra label manner and the limited number of approved drugs puts pressure on drugs being used.

3.6

Health Canada by itself cannot address this issue which is facing the aquaculture industry. One key area for advancement to address this gap is through an increased cooperation and collaborative effort among the concerned stakeholders so that more drugs can be made available for the aquaculture industry keeping in mind the main priority being the safety of Canada's food supply.

3.7

This situation of lack of approved drugs for use in aquaculture is not unique to Canada. Other countries are also dealing with this issue within their own regulatory context. There are aspects which Health Canada can adopt from other countries however, recognizing the differences in regulatory realm of other jurisdictions.

¹ US MUMS Act or the "The Minor Use and Minor Species Animal Health Act of 2004," http://www.fda.gov/cvm/minortoc.htm came into effect in August 2004.

4. Ongoing Initiatives

The Government of Canada, in particular Health Canada, the Canadian Food Inspection Agency (CFIA), and the Department of Fisheries and Oceans (DFO) are cooperating in a number of initiatives to address industry related challenges.

• Health Canada's VDD has established an Expert Advisory Panel on Aquaculture to explore some of these issues and advise on potential mechanisms that will protect food safety, public health as well as the growing industry. The Panel, which was established in June 2006, is composed of experts in toxicology, fish science and aquaculture veterinarians from the private, provincial and federal sectors.
• Under Section C08.010 of the Food and Drug Regulations, Health Canada (VDD) authorizes the temporary use of unapproved drugs through the Emergency Drug Release (EDR) program. VDD is exploring mechanisms by which such authorization would require the generation/collection of data on safety and efficacy of these drugs.
• A National Aquatic Animal Health Program NAAHP,² is being developed by CFIA with DFO supplying diagnostic services and scientific expertise. The focus of the program is on the management of important diseases in Canada. The NAAHP will not address drug use, nor the monitoring or recording thereof except in rare instances where a disease outbreak may be controlled by treatment.

² National Aquatic Animal Health Program ( NAAHP), http://www.inspection.gc.ca/english/anima/aqua/queste.shtml

5. Action Plan

To address the lack of authorized veterinary drugs for use in aquatic species the VDD is undertaking the following activities in conjunction with its Advisory Panel:

• Identification of drugs which are considered critical for the production of aquatic species.
• Explore partnership initiatives with provincial governments, members of the aquaculture industry and academia;
• Policy and guideline document development. Work is underway to identify data requirements for veterinary drugs to be used in aquatic animal species.
• Work with the industry to collect appropriate data to establish interim MRLs and WPs for drugs being used in aquaculture that have not yet received Health Canada authorization.
• Examine best practices in other regulatory jurisdictions.

Key Messages:

• Access to and availability of approved drugs for aquaculture uses is essential for the ongoing demands on aquaculture industry in Canada as well keeping the Canadian food supply safe.
• Health Canada would like to work with affected stakeholders to ensure access to appropriate veterinary drugs for use in aquaculture.