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Appendix 1
Approved Therapeutants for Aquaculture Use
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This appendix provides information on the authorized use of drugs and pesticides in the
aquaculture of fish and crustaceans.
A drug used in aquaculture must be either:
- approved by Health Canada specifically for use in fish or crustaceans;
- authorized as an Emergency Drug Release (EDR) by Health Canada when the drug has not
been approved in Canada (i.e., the drug has not been assigned a Drug Identification Number
(DIN) by Health Canada);
- authorized for testing purposes under an Experimental Studies Certificate, issued by
Health Canada;
- approved as an Investigational New Drug Submission by Health Canada for clinical trials;
or
- prescribed by a licensed veterinarian for "off-label" use (only applies to
products with an assigned Drug Identification Number).
Health Canada's Veterinary Drugs Program is responsible for establishing the maximum
residue limits (MRLs), administrative maximum residue limits (AMRLs) or residue limits for
these drugs. MRLs are published in Table III of Division 15 of the Food and Drugs
Regulations. Administrative MRLs or residue limits are established as policy by the
Veterinary Drugs Program of Health Canada. If levels of drug residues in excess of these
limits are found in fish intended for human consumption, the fish will be considered
"unwholesome", according to Section 6.(1)(a) of the Fish Inspection
Regulations.
Dosages and withdrawal times for veterinary drugs must be followed as indicated in the
veterinary prescription or, in those cases where a prescription is not required, in the
Compendium of Medicating Ingredient Brochures (CMIB) published and maintained by the CFIA.
When an antiparasitic product is orally administered to fish (via feed or another
mechanism) it is deemed to be a drug and it is regulated by the Food and Drugs Act
and Regulations.
When the same antiparasitic is applied externally to fish (not ingested) it is deemed a
pesticide and it is regulated by the Pest Control Products Act. The Pest
Management Regulatory Agency within Health Canada approves or grants emergency release
permits for pesticides under the Pest Control Products Act.
The Veterinary Drugs Program of Health Canada has approved, or temporarily authorized
as an EDR, the use in aquaculture of the following veterinary drug products:
| PRODUCT BRAND NAME |
APPROVED SUBSTANCE |
RESIDUE LIMIT
(µg/g) |
TISSUE |
SPECIES |
| Terramycin-Aqua |
Oxytetracycline |
0.2 2 |
Edible Tissue |
Salmonids
Lobster |
| Romet 30 |
Sulfadimethoxine |
0.1 2 |
Edible Tissue |
Salmonids |
| Ormetoprim |
0.5 |
Muscle |
Salmonids |
| 1 |
Skin |
| Tribrissen 40% |
Sulfadiazine |
0.1 1 |
Edible Tissue |
Salmonids |
| Trimethoprim |
0.1 1 |
Muscle |
Salmonids |
| Aqua Life TMS |
Tricaine methanesulfonate |
0.02 |
Edible Tissue |
Salmonids |
| Aquaflor |
Florfenicol |
0.8 1, 4 |
Muscle |
Salmonids |
| Formalin-R |
Formaldehyde |
n/a 5 |
n/a |
Salmonid eggs |
| Parasite-S |
| Perox-Aid |
Hydrogen peroxide |
n/a 5 |
n/a |
Salmonid eggs |
| Calicide |
Teflubenzuron |
0.3 2 |
Muscle |
Salmonids |
| 3.2 2 |
Skin |
| Slice |
Emamectin benzoate |
0.042 3 |
Muscle |
Salmonids |
- MRL (Maximum Residue Limit) Table III of Division 15 of the Food and
Drugs Regulations
- AMRL (Administrative Maximum Residue Limit)
- EDR (Emergency Drug Release)
- MRL is specified for the metabolite florfenicol amine.
- Regulated biological substance, ubiquitous in nature.
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