Appendix 1 (B)
Therapeutant Use in Aquaculture - Questions and Answers

Preamble: This document outlines key information, for importers and domestic processors of fish and fish products, on the Canadian regulatory and testing requirements for therapeutants in aquaculture production. Fish importers and domestic processors are responsible for ensuring product compliance by implementing measures to address therapeutants in aquacultured fish and crustaceans intended for human consumption.

Content

• General
• Health Canada: Setting the Standards
• Industry: Implementing Controls and Verifying Product Safety
• Canadian Food Inspection Agency: Monitoring and Compliance Verification Activities

General

Q: What are therapeutants and why are they used in aquaculture?

A: Therapeutants are chemical substances used on fish farms or aquaculture operations when necessary to keep aquatic animals (i.e. fish or crustaceans) healthy while they are being raised. Therapeutants could be drugs or pesticides.

In Canada, therapeutants are prescribed by licensed veterinarians after they have diagnosed health problems in aquatic animals under their care. Veterinarians are responsible for treatment using the prescribed therapeutant on the fish farm and are also involved with the aquaculture operator to ensure that the treated fish or crustaceans are safe for human consumption.

While other countries may have different procedures for administrating therapeutants, the final fish product imported into Canada must be safe for human consumption.

Q: What is a veterinary drug?

A: A veterinary drug is a therapeutant that is used to treat a disease in aquatic animals and is usually given to them to consume (for example, through medicated feed). However, some drugs may be given by injection. At this moment, most aquaculture therapeutants in Canada are delivered through feed and are regulated by Health Canada's Veterinary Drugs Directorate (VDD) under the Canadian Food and Drugs Act and Regulations. Information on veterinary drugs and the VDD can be found at:
http://www.hc-sc.gc.ca/dhp-mps/vet/legislation/pol/aquaculture-eng.php

Q: What is a pesticide?

A: When certain therapeutants (such as some antiparasitic products) are added to the water to specifically control only external parasites (i.e. topically applied to fish by submersion in a bath), they are deemed a pesticide and are regulated under the Canadian Pest Control Products Act and Regulations. The Pest Management Regulatory Agency (PMRA) within Health Canada approves pesticides under the Pest Control Products Act. Information on pesticides and the PMRA can be found at:
http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/pmra-arla/index-eng.php

Key Roles in Food Safety

Health Canada: Setting the Standards

Q: What is Health Canada's role with respect to veterinary drugs?

A: The Veterinary Drugs Directorate (VDD) within Health Canada is responsible for protecting human and animal health and the safety of Canada's food supply. Through the VDD, Health Canada 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. For drug products used in food-producing animals, VDD establishes mandatory withdrawal times and sets maximum residue limits (MRLs) and administrative maximum residue limits (AMRLs) for veterinary drugs after it has conducted an extensive review of data submitted by manufacturers and has assessed the veterinary drugs' safety and risk.

Q: What is a Maximum Residue Limit (MRL)?

A: A Maximum Residue Limit (MRL) is an amount of drug residue present in treated aquatic animals that will not pose adverse human health effects if the food is consumed daily over a lifetime. A MRL applies to a specific tissue for a specific species. For example, sulfadiazine (in the approved drug, Tribressen 40% Powder), a drug approved for use in salmonids in Canada, could be administered to salmonids and the residual level in the edible tissues of fish offered for sale cannot exceed the MRL of 0.1 µg/g.

Q: What is an Administrative Maximum Residue Limit (AMRL)?

A: The definition of an Administrative Maximum Residue Limit (AMRL) and a MRL are basically the same since the process and rigour that the VDD uses to assess the safety and risk of a veterinary drug are the same. The only difference is that, for an AMRL, the Canadian legal process to publish this information in the Food and Drug Regulations is in progress. Once the legal process is complete, the AMRL is officially known as an MRL. While their legal status differ, there is no difference between an MRL and AMRL in terms of scientific validity and thus the VDD posts a formal list of established AMRLs on its website. In this context, AMRLs can be a factor in considering if a food is acceptable for sale in Canada and considering action to be taken where the possible adulteration of foodstuffs is suspected or known.

Q: How does Health Canada establish a MRL for a veterinary drug or expand the scope of application of an existing MRL to a new species or target tissue?

A: MRLs are established only after the VDD has conducted extensive reviews of data submitted by manufacturers and has determined that foods containing these veterinary drug residues up to the established levels are safe for human consumption. Health Canada's website provides additional information on the risk assessment and approval process for establishing MRLs:
http://www.hc-sc.gc.ca/dhp-mps/vet/mrl-lmr/mrl-lmr_levels-niveaux-eng.php
http://www.hc-sc.gc.ca/dhp-mps/vet/applic-demande/proces/approval-approbation-eng.php

Q: What if a veterinary drug, which has not been approved by Health Canada, is needed for the emergency treatment of aquatic animals in Canada?

A: Health Canada may provide, under the Emergency Drug Release (EDR) program, an authorization for the sale of a drug, under the Food and Drug Regulations¹. This authorization permits the manufacturer of a new drug to sell a limited quantity of the new drug to a veterinarian.

• The new drug is one which is not marketed in Canada and is requested by a veterinarian as an emergency treatment for aquatic animals under his or her care.
• Before the request is authorized, the veterinarian must provide the VDD with detailed information regarding the emergency treatment of the aquatic animal(s), safety data (including human safety) of the drug, and any other relevant information. Once the evaluation has been completed, the VDD may issue the EDR authorization along with the conditions which must be met (for example, adhering to a withdrawal time).
• Veterinarians are responsible for reporting on the drug use results. Health Canada's website provides additional information on the Emergency Drug Release program

Q: What if a pesticide, which has not been approved by Health Canada, is needed for the emergency treatment of aquatic animals in Canada?

A: The Pest Management Regulatory Agency (PMRA) within Health Canada may grant emergency release permits for pesticides under the Pest Control Products Act. More information concerning this program can be found at:
http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/pmra-arla/index-eng.php

Industry: Implementing Controls and Verifying Product Safety

Q: What do importers and domestic processors need to know about therapeutant use in aquacultured fish and crustaceans?

A: Fish importers and domestic processors should be aware that not all therapeutants that may be accessible to fish farms or aquaculture operations are accepted to be used in aquacultured aquatic animals intended for human consumption. Importers and domestic processors should be knowledgeable of therapeutants which are "banned", "approved" and "accepted to be used" in Canada in relation to aquacultured products so that they can take actions to reduce or eliminate the consumer exposure to therapeutants that may pose a food safety risk.

Q: What are "banned" drugs?

A: According to the Food and Drug Regulations², banned drugs are those drugs which are prohibited for sale for administration to animals that produce food or that are intended to be consumed as food because the drug contains one of the following:

• chloramphenicol or its salts and derivatives;
• a 5-nitrofuran compound;
• clenbuterol or its salts and derivatives;
• a 5-nitroimidazole compound or;
• diethylstilbestrol or other stilbene compounds.

Scientific evidence has shown that exposure to these substances, at any level, is unsafe for consumers. Fish and crustaceans containing any residue from these drugs are in violation of the Food and Drug Regulations³ and the Fish Inspection Regulations and would not be permitted for sale in the Canadian market.

Q: What are "approved" drugs in Canada?

A: Drugs that have a Drug Identification Number (DIN) on the label are drugs that are approved by Health Canada. A list of veterinary drugs approved for sale by Health Canada to be used in aquatic animals can be found at:
http://www.hc-sc.gc.ca/dhp-mps/vet/legislation/pol/aquaculture_anim-eng.php

Any drug residue present in the food must not exceed the MRL or AMRL for that drug set by Health Canada.

Q: Which therapeutants are "accepted to be used" in aquaculture in Canada?

A: A therapeutant "accepted to be used" in aquaculture in Canada can be either of the following:

• A drug authorized for sale by Health Canada to be used specifically in aquatic animals. Health Canada's website provides additional information:
  http://www.hc-sc.gc.ca/dhp-mps/vet/legislation/pol/aquaculture-eng.php
• A drug authorized for sale by Health Canada through an Emergency Drug Release (EDR) when the drug has not been approved in Canada;
• A drug authorized for sale by Health Canada for testing purposes under an Experimental Studies Certificate (ESC);
• A drug authorized for sale by Health Canada as an Investigational New Drug Submission for clinical trials;
• A drug, prescribed by a licensed veterinarian, as extra-label drug use (ELDU) (only applies to products with a Drug Identification Number (DIN) assigned by Health Canada). Please refer to the ELDU Policy Statement of Health Canada for more information:
  http://www.hc-sc.gc.ca/dhp-mps/vet/label-etiquet/index-eng.php
• A pesticide that is approved to be used in aquatic animals by the Pest Management Regulatory Agency (PMRA) within Health Canada. This pesticide should be used according exactly to the label instructions;
• A pesticide which has been granted an emergency release permit by PMRA under the Pest Control Products Act.

Q: Can I import or process fish products that contain therapeutants not "accepted to be used" in aquaculture in Canada?

A: No, any therapeutants which are not considered "accepted to be used" are essentially unapproved and their residues should not be present in fish offered for sale in Canada.

Q: How can importers provide assurances regarding the safety of the aquaculture products they import with respect to therapeutants?

A: All importers should be aware that there could be a food safety risk associated with therapeutants in the aquaculture products they import. To help ensure that consumers are not exposed to non-compliant products, importers are responsible for discussing the potential of therapeutant use and residues in aquaculture products with their suppliers. Fish importers need to take affirmative actions when sourcing product by dealing with suppliers that can provide assurances that the products meet the applicable Canadian requirements and do not contain illegal drug residues. Affirmative actions may include, but are not limited to, providing suppliers with a description of all Canadian regulatory standards for aquaculture products as a part of their product specification outlined in a buyer-seller agreement or selecting producers that use a Hazard Analysis Critical Control Point (HACCP) based system in the production of their fish and seafood products.

Additional information on affirmative actions and importing fish and seafood products into Canada can be found at:
http://www.inspection.gc.ca/english/fssa/fispoi/import/pol/queste.shtml

Quality Management Program Importer (QMPI) licence holders must verify that each lot of imported aquatic animals complies with Canadian regulatory requirements and applicable product standards by conducting inspection activities as outlined in their QMPI plan. The QMPI licence holder is also required to review their QMPI plan annually and perform routine verification activities as appropriate, to ensure it is functioning effectively.

Q: How can domestic processors provide assurances regarding the safety of the aquaculture products they process with respect to therapeutants?

A: Domestic processors should discuss the potential for therapeutant use and residues with their suppliers of aquaculture products when establishing drug residue controls under their Quality Management Program (QMP) plan. Buyer-seller agreements, such as a Supplier Quality Assurance (SQA) agreement and/or product testing are examples of measures that can be implemented to assure that the product meets Canadian requirements. Processors should also ensure that their SQA's and/or HACCP plan related to therapeutants are kept up to date as needed.

Domestic processors must conduct monitoring activities so that each lot of incoming aquatic animals complies with Canadian regulatory requirements and applicable product standards as outlined in their QMP plan. The processor is also required to review their QMP plan annually and perform routine verifications, including their HACCP plan, to ensure it is functioning effectively.

When establishing drug residue controls, establishments that process aquacultured aquatic animals in Canada should also give consideration to Health Canada's Emergency Drug Release Program, which allows veterinarians controlled access to drugs which have not been approved for use in aquaculture.

Q: What is the policy for using private laboratory services to test fish and fish products for therapeutants to determine regulatory compliance?

A: Importers and domestic processors that use a private (third party) laboratory to test fish and fish products to verify regulatory compliance shall adhere to the CFIA Policy on the Use of Third Party Laboratories for Testing Fish and Fish Products Under the Fish Inspection Program

Canadian Food Inspection Agency: Monitoring and Compliance Verification Activities

Q: What is the Canadian Food Inspection Agency's (CFIA) role with respect to therapeutants and assuring food safety?

A: The CFIA's inspection program routinely monitors commercially sold aquaculture products to verify that the residue limits established by Health Canada have not been exceeded and that the products do not contain illegal therapeutants. Product analysis, using fully validated methods, are performed in accredited CFIA laboratories based on an ISO 17025 system. The CFIA will take appropriate regulatory action on non-compliant aquaculture products.

By conducting product monitoring and other verification activities, the CFIA is able to assess whether effective controls have been implemented by domestic processors and licensed importers that will provide reasonable assurance that aquaculture products consistently meet Canadian regulatory requirements concerning therapeutants.

Q: Where can I find a list of aquaculture therapeutants currently monitored by the Canadian Food Inspection Agency (CFIA)?

A: A List of aquaculture therapeutants that the CFIA currently monitors (imported and domestically produced aquacultured products), including but not limited to, "banned" drugs and "accepted to be used" therapeutants, can be found at:
http://www.inspection.gc.ca/english/fssa/fispoi/man/samnem/app1ae.shtml

Footnotes:

¹ Section C.08.010 and C.08.011 of the Food and Drug Regulations

² Section C.01.610.1 of the Food and Drug Regulations

³ Article B.01.048(1)(2)(d) of the Food and Drug Regulations

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