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Appendix 1(A) - CFIA Aquaculture Therapeutant Residue Monitoring List
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This reference list identifies the therapeutants that are currently being monitored in imported and domestically produced aquacultured fish and crustaceans for compliance with Canadian regulatory requirements.
General information on therapeutant use in aquaculture in Canada can be found in Appendix 1 (B) - Therapeutant Use in Aquaculture - Questions and Answers
Monitoring List Legend / Explanatory Notes
|Class Name||Substance Name||Marker Residue / Metabolite||Regulatory Use Status||Species||Tissue||Action LevelTable Note 10:
|Action LevelTable Note 10:
|Amphenicols||Florfenicol||Florfenicol amine||Approved Table Note 11||Salmonids||Muscle||0.8 a||800 a|
|Amphenicols||Chloramphenicol||N/A||Banned Table Note 12||All||N/A||DTC||DTC|
|Amphenicols||Thiamphenicol||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Avermectins||Emamectin Benzoate||N/A||Approved Table Note 11||Salmonids||Muscle||0.1 AMRL||100 AMRL|
|Avermectins||Ivermectin||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Benzoylureas||Teflubenzuron h||N/A||Approved Table Note 11||Salmonids||Muscle||0.3||300|
|Benzoylureas||Teflubenzuron h||N/A||Approved Table Note 11||Salmonids||Skin||3.2||3200|
|Fluoro-quinolones||Ciprofloxacin||N/A||Not accepted to be used||All||N/A||0.001 b||1.0 b|
|Fluoro-quinolones||Danofloxacin||N/A||Not accepted to be used||All||N/A||0.001 b||1.0 b|
|Fluoro-quinolones||Difloxacin||N/A||Not accepted to be used||All||N/A||0.001 b||1.0 b|
|Fluoro-quinolones||Enrofloxacin||N/A||Not accepted to be used||All||N/A||0.001 b||1.0 b|
|Fluoro-quinolones||Marbofloxacin||N/A||Not accepted to be used||All||N/A||0.001 b||1.0 b|
|Fluoro-quinolones||Norfloxacin||N/A||Not accepted to be used||All||N/A||0.001 b||1.0 b|
|Fluoro-quinolones||Orbifloxacin||N/A||Not accepted to be used||All||N/A||0.001 b||1.0 b|
|Fluoro-quinolones||Sarafloxacin||N/A||Not accepted to be used||All||N/A||0.001 b||1.0 b|
|Macrolides||Erythromycin||N/A||EDR||Fish, Crustaceans||Muscle||0.03 c||30 c|
|Nitrofurans||Furaltadone||(AMOZ) 3-Amino-5-morphinomethyl- oxazolidin-2-one||Banned Table Note 12||All||N/A||DTC||DTC|
|Nitrofurans||Furazolidone||(AOZ) 3-Amino- 2-oxazolidinone||Banned Table Note 12||All||N/A||DTC||DTC|
|Nitrofurans||Nitrofurantoin||(AHD) 1-Aminohydantoin hydrochloride||Banned Table Note 12||All||N/A||DTC||DTC|
|Nitrofurans||Nitrofurazone||(SEM) Semicarbazide||Banned Table Note 12||All||N/A||DTC||DTC|
|Nitroimidazoles||2-hydroxymethyl-1-methyl-5-nitroimidazole (HMMNI)||N/A||Banned Table Note 12||All||N/A||DTC||DTC|
|Nitroimidazoles||Ipronidazole (IPZ)||N/A||Banned Table Note 12||All||N/A||DTC||DTC|
|Nitroimidazoles||1-methyl-2-(2'-hydroxyisopropyl)-5-nitroimidazole (IPZ-OH)||N/A||Banned Table Note 12||All||N/A||DTC||DTC|
|Nitroimidazoles||Metronidazole (MNZ)||N/A||Banned Table Note 12||All||N/A||DTC||DTC|
|Nitroimidazoles||1-(2- hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole (MNZ-OH)||N/A||Banned Table Note 12||All||N/A||DTC||DTC|
|Nitroimidazoles||Ronidazole (RNZ)||N/A||Banned Table Note 12||All||N/A||DTC||DTC|
|Nitroimidazoles||Dimetridazole (DMZ)||N/A||Banned Table Note 12||All||N/A||DTC||DTC|
|Pyrethroids||Cypermethrin||N/A||Not accepted to be used||All||N/A||0.1||100|
|Pyrethroids||Deltamethrin||N/A||Not accepted to be used||All||N/A||0.1||100|
|Quinolones||Flumequine||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Quinolones||Oxolinic Acid||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Steroids||Boldenone (17 beta-boldenone)||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Steroids||Methyltestosterone (17 alpha-methyltestosterone)||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Steroids||Nandrolone (17 beta-19-nortestosterone)||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Steroids||epi-Boldenone (17 alpha-boldenone)||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Steroids||epi-Nandrolone (17 alpha-19-nortestosterone)||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Stilbenes||Dienestrol (DIEN)||N/A||Banned Table Note 12||All||N/A||DTC||DTC|
|Stilbenes||Diethylstilbestrol (DES)||N/A||Banned Table Note 12||All||N/A||DTC||DTC|
|Stilbenes||Hexestrol (HEX)||N/A||Banned Table Note 12||All||N/A||DTC||DTC|
|Sulfonamides||Ormetoprim||N/A||Approved Table Note 11||Salmonids||Edible Tissue||0.1 AMRL||100 AMRL|
|Sulfonamides||Sulfadiazine||N/A||Approved Table Note 11||Salmonids||Edible Tissue||0.1||100|
|Sulfonamides||Sulfadimethoxine||N/A||Approved Table Note 11||Salmonids||Edible Tissue||0.1 AMRL||100 AMRL|
|Sulfonamides||Trimethoprim||N/A||Approved Table Note 11||Salmonids||Muscle||0.1||100|
|Sulfonamides||Sulfacetamide||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Sulfonamides||Sulfa- chloropyridazine||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Sulfonamides||Sulfadoxine||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Sulfonamides||Sulfaguanadine||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Sulfonamides||Sulfamerazine||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Sulfonamides||Sulfamethazine||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Sulfonamides||Sulfamethiazole||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Sulfonamides||Sulfamethoxazole||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Sulfonamides||Sulfa- methoxypridazine||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Sulfonamides||Sulfa- monomethoxine||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Sulfonamides||Sulfamoxole||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Sulfonamides||Sulfanilamide||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Sulfonamides||Sulfapyridine||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Sulfonamides||Sulfaquinoxaline||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Sulfonamides||Sulfathiazole||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Sulfonamides||Sulfisoxazole||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Tetracyclines||Doxycycline||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Tetracyclines||Oxytetracycline||N/A||Approved Table Note 11||Salmonids, Lobsters||Muscle||0.2||200|
|Tetracyclines||Chlorotetracycline||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Tetracyclines||Tetracycline||N/A||Not accepted to be used||All||N/A||DTC||DTC|
|Triphenyl-methane Dyes||Gentian Violet||Leucogentian
|Not accepted to be used||All||N/A||notes f, g||notes f, g|
|Triphenyl-methane Dyes||Malachite Green||Leucomalachite Green||Not accepted to be used||All||N/A||notes d, e||notes d, e|
- Table note 10
Action Level Column
For therapeutants where a predetermined guideline has been established by Health Canada (such as Maximum Residue Limits (MRLs), Administrative Maximum Residue Limits (AMRLs), interim guidelines, minimum performance Limit of Quanitification, etc.), the analytical laboratory must use a validated method that is capable of providing an accurate result so that an assessment can be made on whether the product meets the applicable guideline. The residue limits for these therapeutants in the sample are identified in the "Action Level" column.
For therapeutants where a predetermined guideline has not been established by Health Canada and are not accepted for use in aquaculture in Canada, any residue detected in the sample is a violation of Article 4 (a) and/or (d) of the Food and Drugs Act and Section 6 (1) (a) of the Fish Inspection Regulations. The analytical laboratory must use a validated method and report any of these residues that are detected and positively confirmed by Mass Spectrometry (MS). The action level is indicated as "DTC" (i.e. Detected above the reporting limit) in the "Action Level" column.
- Table note 11
Action levels presented are derived from Health Canada - Veterinary Drugs Directorate:
Table 1. Administrative Maximum Residue Limits (AMRLs) and Maximum Residue Limits (MRLs) set by Health Canada
- Table note 12
Banned drugs are those drugs which are prohibited for sale and use on animals (including fish) that produce food or that are intended to be consumed as food as stipulated in the Food and Drug Regulations (s. B.01.048 and C.01.610.1).
A lot of fish is considered unacceptable when residues of a substance found in the product exceed the action level specified in this list.
(Note: for Triphenylmethane Dyes - refer to notes d, e, f and g for relevant information).
Monitoring List Legend / Explanatory Notes
Abbreviations / Terms
AMRL - Administrative Maximum Residue Limit: The definition for AMRL and MRL are basically the same except AMRL is awaiting completion of the legal process for publishing in Food and Drug Regulations.
DTC - Detected above the reporting limit
EDR - Emergency Drug Release: Program administered by Health Canada - Veterinary Drugs Directorate.
Edible Tissue: includes muscle and skin
MRL - Maximum Residue Limit: As stipulated in Food and Drug Regulations, Division 15, Table III. Established value is found in the "Action Level" Column.
a A lot of fish will be considered reject when the sum of florfenicol (parent drug) and florfenicol amine (metabolite) detected in the sample exceeds the florfenicol MRL.
b As a minimum performance level of the laboratories testing for fluoroquinolones, the laboratory must have a limit of quantification (LOQ) of at least 1.0 ng/g for fluoroquinolones.
c Interim action level set by Health Canada.
Malachite Green and Leucomalachite Green Notes
d As a minimum performance level of the laboratories testing for Malachite Green (MG) or Leucomalachite Green (LMG), the laboratory must have a limit of quantification (LOQ) of at least 0.5 ng/g for MG or LMG.
e The "Interim Guidelines for the Presence of Malachite Green (MG) and Leucomalachite Green (LMG) in Aquaculture Fish Products" established by Health Canada and published in the CFIA Industry Notice of March 29, 2006 are as follows:
- Malachite green is not permitted in Canada for use during any part of the aquaculture fish production life-cycle.
- The interim guidelines from Health Canada and CFIA's product acceptability criteria applicable to imported and domestic fish products are described below:
|MG or LMG Levels||Product Action|
|≤ 0.50 ng/g for MG or LMG (Interim LOQ for MG or LMG)||No regulatory actions will be taken.|
|> 1.00 ng/g for MG or LMG||Product is unacceptable. Appropriate regulatory actions will be taken.|
|> 0.50 ng/g to ≤ 1.00 ng/g for MG or LMG
(Note: Gathering of information will be required to determine deliberate use)
|Product is unacceptable unless a review of information gathered shows there has been no deliberate use. Appropriate regulatory actions will be taken, as required.|
For products found to contain levels > 0.50 and ≤ 1.00 ng/g of MG or LMG, the following approach will be used:
- Importers will have the option of gathering information in order to provide evidence of non-deliberate use. The importers should contact the local CFIA office. On a case by case basis, the CFIA will determine when the option for gathering information is available. This will be based on the importer's Quality Management Program and/or on the presence of foreign arrangements or regulatory links with the respective foreign authorities. CFIA will take the appropriate regulatory action.
- Federally registered processors will be required to notify the CFIA of these results and take the appropriate corrective actions according to their QMP plan. Appropriate corrective actions should include gathering information to determine if deliberate use of MG occurred during any part of the aquaculture fish production life cycle. The processor will provide their findings to the CFIA and the information will be reviewed to determine the regulatory compliance. The CFIA may complete a Compliance Verification to determine whether the QMP requirements have been met.
Gentian Violet and Leucogentian Violet Notes
f As a minimum performance level of the laboratories testing for Gentian Violet (GV) or Leucogentian Violet (LGV), the laboratory must have a limit of quantification (LOQ) of at least 0.5 ng/g for GV or LGV.
g Gentian violet is not permitted in Canada for use during any part of the aquaculture fish production life-cycle.
As a result of on-going discussions with Health Canada regarding Gentian Violet as a therapeutant and as a possible contaminant, the interim guidelines for the presence of GV and LGV and CFIA's product acceptability criteria applicable to imported and domestic aquacultured fish products have been modified as follows:
|GV or LGV Levels||Product Action|
|< 0.50 ng/g for GV and/or LGV (Interim LOQ for GV or LGV)||No regulatory actions will be taken.|
|Sum GV & LGV ≥ 1.0 ng/g
GV ≥ 1.0 ng/g & LGV < 0.5 ng/g or
GV < 0.5 ng/g & LGV ≥ 1.0 ng/g or
GV ≥ 0.5 ng/g & LGV ≥ 0.5 ng/g
|Product is unacceptable. Appropriate regulatory actions will be taken.|
|GV < 0.5 ng/g & LGV ≥ 0.5 ng/g and < 1.0 ng/g or
GV ≥ 0.5 ng/g and < 1.0 ng/g & LGV < 0.5 ng/g
|This result will trigger a follow-up investigation for possible therapeutant use prior to making a lot decision.|
|GV ≥ 0.5 ng/g & LGV not detected at the reporting limit||This result will trigger a follow-up investigation for possible post harvest contamination prior to making a lot decision.|
When a follow up investigation is needed, laboratory reports/results (i.e. from a QMPI importer) should be forwarded to a CFIA inspector.
The CFIA Inspector will communicate with their respective Regional/Area Program Staff who will liase with the National Manager Technical Standards (or delegate), Fish, Seafood and Production Division. The follow up investigation approach may include, but not limited to gathering evidence of non-deliberate use, collecting and reviewing additional information, etc., for an assessment and this will be determined on a case-by-case basis.
h The monitoring of teflubenzuron in aquaculture products is under review and is not applicable at this time.
Version: February 12, 2013
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.
What are therapeutants and why are they used in aquaculture?
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.
What is a veterinary drug?
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. For information on veterinary drugs and the VDD consult the Web site.
What is a pesticide?
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 PMRA can be found at the Health Canada website.
Key Roles in Food Safety
Health Canada: Setting the Standards
What is Health Canada's role with respect to veterinary drugs?
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.
What is a Maximum Residue Limit (MRL)?
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.
What is an Administrative Maximum Residue Limit (AMRL)?
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.
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?
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.
What if a veterinary drug, which has not been approved by Health Canada, is needed for the emergency treatment of aquatic animals in Canada?
Health Canada may provide, under the Emergency Drug Release (EDR) program, an authorization for the sale of a drug, under the Food and Drug RegulationsFootnote 13. 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
What if a pesticide, which has not been approved by Health Canada, is needed for the emergency treatment of aquatic animals in Canada?
The Pest Management Regulatory Agency (PMRA) within Health Canada may grant emergency release permits for pesticides under the Pest Control Products Act.
Industry: Implementing Controls and Verifying Product Safety
What do importers and domestic processors need to know about therapeutant use in aquacultured fish and crustaceans?
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.
What are "banned" drugs?
According to the Food and Drug RegulationsFootnote 14, 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 is unsafe for consumers. Fish and crustaceans containing any residue from these drugs are in violation of the Food and Drug RegulationsFootnote 15 and the Safe Food for Canadians Regulations and would not be permitted for sale in the Canadian market.
What are "approved" drugs in Canada?
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 the Health Canada website.
Any drug residue present in the food must not exceed the MRL or AMRL for that drug set by Health Canada.
Which therapeutants are "accepted to be used" in aquaculture in Canada?
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.
- 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 Health Canada's ELDU Policy for more information.
- 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.
Can I import or process fish products that contain therapeutants not "accepted to be used" in aquaculture in Canada?
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.
How can importers provide assurances regarding the safety of the aquaculture products they import with respect to therapeutants?
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.
Find additional information on affirmative actions and importing fish and seafood products into Canada.
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.
How can domestic processors provide assurances regarding the safety of the aquaculture products they process with respect to therapeutants?
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 SQAs 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.
What is the policy for using private laboratory services to test fish and fish products for therapeutants to determine regulatory compliance?
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
What is the Canadian Food Inspection Agency's (CFIA) role with respect to therapeutants and assuring food safety?
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.
Where can I find a list of aquaculture therapeutants currently monitored by the Canadian Food Inspection Agency (CFIA)?
Consult 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.
Appendix 2 - Bacteriological Guidelines for Fish and Fish Products (end product)
|Test Organism Table Note 16||Product Type||Number of sample units||Acceptance number (c) Table Note 17||m/g Table Note 17||M/g Table Note 17||Criteria for action|
|Escherichia coli||Cooked or ready-to-eat products||5||1||4||40||Reject if 2 or more units exceed m, or if any unit exceeds M|
|Escherichia coli||Raw bivalve molluscs||5||1||230/100 g||330/100 g||Reject if 2 or more units exceed m, or if any unit exceeds M|
|Escherichia coli||All other types||5||2||4||40||Reject if 3 or more units exceed m, or if any unit exceeds M|
|Coagulase-Positive Staphylococci||All types||5||1||1000||10000||Reject if 2 or more units exceed m, or if any unit exceeds M|
|Salmonella spp.||All types||5||Absent in each 25 g sample or in pooled samples of 125 g.||-||-||Reject if Salmonella spp is detected|
|Vibrio cholerae||Cooked or ready-to-eat products||5||Absent in each 25 g sample or in pooled samples of 125 g||-||-||Reject if Vibrio cholerae is detected.|
|Vibrio parahaemolyticus Table Note 18||Live Oyster||5||0||100||-||Reject if any unit exceeds m|
- Table Note 16
The analysis of all fish or fishery products shall be conducted in accordance with approved methods. Approved methods can be obtained from the Health Canada Compendium of Analytical Methods. Note that the most recent published version of the method should be used. The "application" section of the method chosen must be appropriate for the intended purpose.
Other methods of analysis may be considered acceptable. For consideration of alternative methods, please contact the CFIA Food Safety Science Directorate (FSSD), Executive Director through the following e-mail address CFIA.LCD-DCL.ACIA@inspection.gc.ca
- Table Note 17
m - number of bacteria per gram separating acceptable from marginally acceptable samples, c - number of samples that may exceed this number of bacteria per gram, M - no sample can exceed this number of bacteria per gram
- Table Note 18
The guideline, intended for oysters destined for raw consumption, means that none of the five sample units can exceed 100 Vibrio parahaemolyticus MPN/g of oysters.
Listeria monocytogenes (From Health Canada's "Policy on Listeria monocytogenes in Ready-to-Eat Foods")
|Product Type / Category Table Note 20||Laboratory method to be applied||Action Level|
|RTE Fish products in which the growth of L. monocytogenes can occur and could exceed 100 CFU/g before the end of the stated shelf-life.
Includes all products that do not fall in either below-mentioned product types.
(Equivalent to Category 1 foods in the HC Listeria policy)Table Note 21
|Presence/absence in 125 g
(MFHPB-30 Table Note 24) on 5 sample units of 25 g each
|RTE Fish products in which the growth of L. monocytogenes can occur but is limited to levels no greater than 100 CFU/g over the course of their stated shelf-life.
RTE products that have a refrigerated shelf-life of 5 days or less fall under this category.
Other products require validation data Table Note 22 demonstrating growth cannot exceed 100 CFU/g Table Note 23.
(Equivalent to Category 2A foods in the HC Listeria policyTable Note 21)
|Enumeration in 50 g
(MFLP-74 Table Note 24) on 5 sample units of 10 g each
|> 100 CFU/g Table Note 23|
|RTE Fish products in which growth of L. monocytogenes can not occur over the course of the stated shelf-life.
Products with the following characteristics fall under this category:
For products that don't meet the above characteristics, validation data Table Note 22 demonstrating the absence of growth is required.
(Equivalent to Category 2B foods in the HC Listeria policyTable Note 21)
|Enumeration in 50 g (MFLP-74 Table Note 24) on 5 sample units of 10 g each||> 100 CFU/g Table Note 23|
- Table Note 20
For further guidance on the determination of a product category, see Figure 1 Classification Of Ready-to Eat Foods in the Health Canada document Validation of Ready-to-Eat Foods for Changing the Classification of a Category 1 into a Category 2A or 2B Food - in relation to Health Canada's Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011).
- Table Note 21
Health Canada's "Policy on Listeria monocytogenes in Ready-to-Eat Foods" will be referred to as the "HC Listeria Policy" validation.
- Table Note 22
See HC's guide on "Listeria monocytogenes Challenge Testing of Ready-to-Eat Refrigerated Foods" for information on challenge testing as part of validation.
- Table Note 23
Counts between 5 and 100 CFU/g can be an indication of a possible loss of control and should prompt the processor to verify and/or re-evaluate his process controls.
- Table Note 24
Or any other method published in the Health Canada's Compendium of Analytical Methods for Listeria monocytogenes in which the "application" section is appropriate for the intended purpose (e.g., MFHPB-methods and MFLP-methods).
Appendix 3 - Canadian Guidelines for Chemical Contaminants and Toxins in Fish and Fish Products
|Contaminants||Product Type||Action Level Table Note 25|
|MercuryTable Note 26||Swordfish, shark, escolar, orange roughy, marlin; tuna in fresh and frozen form||1 ppm|
|Mercury||All other fish, including canned tuna||0.5 ppm|
|Arsenic||Fish proteinTable Note 27||3.5 ppm|
|Lead||Fish protein||0.5 ppm|
|Fluoride||Fish protein||150 ppm|
|2,3,7,8 TCDD (Dioxin)||All fish||20 ppt
|DDT and metabolites
(DDD and DDE)
|All fish||5.0 ppm|
|PCB||All fish||2.0 ppm
|Piperonyl butoxide||Dried Cod||1.0 ppm|
|Other agricultural chemicals or their derivatives||All fish||0.1 ppm|
- Table Note 25
Based on contaminant levels in wet weight of muscle tissue; does not apply to other types of tissues (e.g. roe, organ meat) or products (e.g. oil), unless otherwise specified in the product type description. For dehydrated or concentrated products, the action level applies to the food that is rehydrated or reconstituted to its original form.
- Table Note 26
Health Canada has issued consumption advice for certain types of fish in order to maintain mercury exposure within safe levels.
- Table Note 27
"Fish protein" is a standardized product that is defined in B.21.027 of the Food and Drug Regulations
Sampling: Samples to consist of a minimum of 5 units representative of the lot. Analysis will be performed on the composite of all sample units.
Criteria for Action: A lot of fish will be considered reject if the sample value exceeds the action level. Fish or fish products exceeding these guidelines may be permitted for export if they do not violate regulations of the importing country.
|Toxins||Product Type||Action Level|
|Histamine Table Note 28||Enzyme ripened products (e.g. anchovies, anchovy paste, fish sauce)||20 mg/100 g|
|Histamine Table Note 28||All other fish products (e.g. canned or fresh or frozen tuna, mackerel, mahi-mahi)||10 mg/100 g|
|Saxitoxins (PSP) Table Note 29||Bivalve molluscan shellfish (edible tissue)||80 µg / 100 g|
|Domoic Acid (ASP) Table Note 29||Bivalve molluscan shellfish (edible tissue)||20 µg/g|
|Okadaic Acid (OA) + DTX1 + DTX2 + OA esters + DTX1 esters + DTX2 esters (DSP) Table Note 29||Bivalve molluscan shellfish (edible tissue)
Bivalve molluscan shellfish digestive tissue
|0.2 µg/g (under review)
1 mg/kg (under review)
PTX-1, PTX-2, PTX-3, PTX-4, PTX-6 and PTX-11
|Bivalve molluscan shellfish (edible tissue)
Bivalve molluscan shellfish digestive tissue
- Table note 28
- Samples are collected according to Sampling Plan 1 (AQL 6.5) for initial inspection and Sampling Plan 2 (AQL 6.5) for reinspection. See the Sampling Policy and Procedures
- Any sample exceeding 50 mg/100 g will result in the lot being rejected with no right to reinspection.
- The acceptance number is that corresponding to the number for decomposition.
- Table note 29
PSP, ASP and DSP (Paralytic Shellfish Poisoning, Amnesic Shellfish Poisoning - Diarrhetic Shellfish Poisoning
- Procedures for closure of shellfish areas, and possible recall of product due to samples of shellfish containing toxin levels equal to or greater than the above action levels can be found in Chapter 11 of the Canadian Shellfish Sanitation program
- The minimum acceptable sample is that which when shucked will produce 100 g of drained meats from 5 pooled sub-samples. Depending on the size of animals, the total number of shellfish required varies from 3 (geoduck) to 25 (pink scallops).
|Additive Table Note 30||Product Type Table Note 31||Background Levels Table Note 32||Amount permitted to be Added||Action Level|
|Nitrites||All fish and fish products (except marine mammal meat Table Note 33)||15 ppm (see note 2)||Not permitted||>15 ppm
(see note 2)
|Nitrates||All fish and fish products||15 ppm (see note 2)||Not permitted||>15 ppm
(see note 2)
|Sulphites Table Note 34||Clams (raw and canned)||10 ppm||Not permitted||>10 ppm|
|Phosphates Table Note 35||Shrimp (frozen, raw, cooked and canned)||1.60%||0.5%||>2.10%|
|Phosphates Table Note 35||Scallops (raw)||1.47%||Not permitted||>1.47%|
|Phosphates Table Note 35||Frozen fish fillets, frozen minced fish, canned seafood||1.37%||0.5%||>1.87%|
|Phosphates Table Note 35||Crab (frozen, raw, canned and cooked)||1.70%||0.5%||>2.20%|
|Phosphates Table Note 35||Lobster (frozen, raw, canned and cooked)||1.47%||0.5%||>1.97%|
|Phosphates Table Note 35||Surf clams (frozen, raw and cooked)||1.00%||0.5%||>1.50%|
|Phosphates Table Note 35||A blend of prepared fish and prepared meat||1.37%||0.1%||>1.47%|
|Phosphates Table Note 35||Squid||1.10%||0.5%||>1.60%|
- Table Note 30
The compounds listed in this table are food additives; however some background levels may occur naturally in some foods. See Division 16 of the Food and Drug Regulations.
- Table Note 31
See Division 21 of the Food and Drug Regulations.
- Table Note 32
When the additive is not permitted, then the action level is the background level or detection limit; when the additive is permitted, then the action level is the background level or detection limit plus the permitted amount.
- Table Note 33
Marine mammals, including seals are included in the definition of "fish" as per the Canadian Food and Drug Regulations. Sodium nitrite is permitted in marine mammal meats at the maximum level of 200 ppm.
- Table note 34
Calculated as sulphur dioxide.
- Table note 35
Calculated as sodium phosphate, dibasic.
- If a processor can provide reliable data for naturally occurring background levels that are higher than those shown above, this may be considered before product action is taken.
- Some herbs, including parsley, contain high levels of naturally occurring nitrates. This has to be considered when nitrates are detected in fish products containing herbs as an ingredient.
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