Industry Guidance for Researchers

You may need extra time to plan your study

This guidance document is for researchers who will:

• receive declared wild or cultured finfish or molluscs, live or dead, for the purpose of research;
• receive a declared reportable aquatic animal disease agent for the purpose of research; or
• send a declared wild or cultured finfish or molluscs, live or dead, or a declared thing for the purpose of research or another end use, for example, culture.

Research facilities in Canada that import infectious materials with aquatic animal disease agents or aquatic animals into Canada already require an import permit from the CFIA. Similar requirements are now necessary to move finfish and molluscs as well as materials with the disease agents of the declared diseases within Canada.

A permit from the CFIA may be required:

• if the animal, including its carcass or a tissue, the disease agent, or another declared thing is coming from an area with a different reportable aquatic animal disease status than the area where the research facility is located,
• when sending an animal or thing from the research facility to an area with a different reportable aquatic animal disease status than the area where the research facility is located.

For more information, please review the declarations.

Researchers have three options when sending or receiving a declared animal, live or dead, or a declared thing:

1. Receive the animal or thing with an unknown disease status into a biocontained facility; or
2. Send or receive healthy animals as long as:
   • they have been inspected and tested by the CFIA,
   • the test results are determined to be negative, and
   • they have been kept segregated to prevent their exposure to the reportable diseases.
3. Send or receive a thing as long as:
   • it has been decontaminated; and
   • it has been kept segregated to prevent exposure to the reportable diseases.

The research facility must be biocontained when researchers are bringing in a reportable disease agent that does not occur in the area where the facility is located or bringing in wild finfish or molluscs harvested directly from the natural waterways of Canada.

The research facility should complete the application for a Domestic Movement Permit Application for Closed Facilities Within Canada Receiving Aquatic Animals and/or Things From Infected, Buffer or Provisionally Free Areas (CFIA/ACIA 5749) in order to bring in or receive:

• wild finfish or molluscs, including their germplasm or fertilized eggs, that are harvested directly from the natural waters of Canada, or
• a reportable disease agent, or
• animals or things with an unknown health status.

If the animals or things require to be segregated, inspected and tested, or decontaminated before they are moved to your facility, researchers should request that the owner of the animals or things apply for either a

• Domestic Movement Permit Application to Move Finfish and/or Things within Canada (CFIA/ACIA 5743) or
• Domestic Movement Permit Application to Move Molluscs and/or Things within Canada (CFIA/ACIA 5758)

A permit to receive finfish germplasm will also be issued to the researcher, if applicable.

A Domestic Movement Permit Application to Move Finfish and/or Things within Canada (CFIA/ACIA 5743) or a Domestic Movement Permit Application to Move Molluscs and/or Things within Canada (CFIA/ACIA 5758) is required when sending declared animals, carcasses or things from the research facility.

Researchers that may require a permit for live or dead animals from the Canadian Food Inspection Agency (CFIA) may also require one from Fisheries and Oceans Canada and/or a province or territory in which the research facility is located. For example, bringing certain species of finfish into the research facility may be prohibited without authorization from the province. For more information, visit the Introductions and Transfers web site.

The period of time that the permit is valid is flexible depending on the needs of a researcher's study. Please indicate your research study needs on the application and discuss them with the CFIA Inspector who will work with you to verify your compliance with the permit conditions.

There are five sets of permit conditions outlined below depending on your needs. Choose the movement scenario that is applicable to view permit conditions:

• Permit Conditions to Receive Animals and Things into a Biocontained Facility;
• Permit Conditions for Receiving Finfish Germplasm from a Premises where Segregation, Inspection and Testing was Conducted;
• Permit Conditions for Sending Finfish (pre-hatch life stage), Live or Dead, from a Research Facility that Requires Segregation, Inspection and Testing; or
• Permit Conditions for Sending Finfish or Molluscs (post-hatch life stage) from a Research Facility that Requires Segregation, Inspection and Testing;
• Permit Conditions for Sending a Thing from a Research Facility that Requires Decontamination and Segregation.

Additional information:

• How to comply with the permit conditions
• General information related to movements
• Important definitions

Permit Conditions Receive Animals and Things into a Biocontained Facility

1. The permit holder controls and handles the movement of the animal or thing in a manner that prevents the spread of diseases, toxic substances and vectors;
2. The permit holder keeps, for two years after the movement of the animal or thing, a copy of the permit and a record of the date of movement and the name and address of the place from which the animal or thing is moved, as well as the quantity or volume of the animals or things;
3. The permit holder makes that copy and those records available for inspection by a CFIA inspector on request;
4. The animal or thing to be covered by this permit is not under any other movement restriction imposed under a law of Canada or a province, and is not intended for destruction for disease control purposes;
5. The reportable disease status of the animal or thing remains the same as declared for the area of origin of the animal or thing. The permit holder must notify the CFIA of any change in the reportable disease status of the animal or thing;
6. The destination premises has physical, operational and decontamination measures documented in a preventive control plan^Footnote 1 to prevent the spread of any of the reportable diseases from the destination premises and these measures are implemented;
7. The permit holder must notify the CFIA of any breach in implementation of the preventive control plan that may result in spread of any of the reportable diseases from the destination premises;
8. The permit holder must notify the CFIA of any loss of integrity of packaging during transport of the animal or thing to the destination premises;
9. No transfer or shipping from the destination premises of the animal or thing, or anything derived from that animal or thing that is still infectious, can occur without the prior written consent of, or a permit issued by the CFIA.

Permit Conditions if you Receive Finfish Germplasm from a Premises where Segregation, Inspection and Testing was Conducted

1. The disease status of the area of origin that is named in this permit does not change between the time of issuance of this permit and the time of the movement;
2. The permit holder controls and handles the movement of the animal in a manner that prevents the spread of diseases, toxic substances and vectors;
3. The permit holder keeps, for two years after the movement of the animal, a copy of the permit and a record of the date of movement and the name and address of the place from which the animal is moved, as well as the quantity or volume of the animals;
4. The permit holder makes that copy and those records available for inspection by a CFIA Inspector on request;
5. The animal to be covered by this permit is not under any other movement restriction imposed under a law of Canada or a province, and is not intended for destruction for disease control purposes;
6. The permit holder must notify the CFIA of any loss of integrity of packaging during transport of the animal described in Section C to the destination premises described in Section B.
7. The animal holding unit used to move the animal described in Section C is handled and disposed of in a manner that prevents the spread of any of the reportable diseases and vectors from the unit.
8. The fertilized egg derived from the animal described in Section C must be decontaminated in a manner that will inactivate or remove any of the reportable diseases and vectors according to a CFIA-recognized protocol. The permit holder must notify the CFIA if any deviation in the protocol occurs.
9. Any equipment and materials that the animal described in Section C comes in contact with prior to decontamination of the fertilized egg must be decontaminated or disposed of in a manner that prevents the spread of any of the reportable diseases and vectors.
10. The waste water generated during the fertilization process and decontamination protocol is treated or disposed of in a manner that prevents the spread of any of the reportable diseases and vectors.

Permit Conditions if you Send Finfish (pre-hatch life stage), Live or Dead, from your Research Facility that Requires Segregation, Inspection and Testing

Please note that not all the permit conditions will apply as some depend on the type of animal being sent.

1. The disease status of the area of origin that is named in this permit does not change between the time of issuance of this permit and the time of the movement;
2. The permit holder controls and handles the movement of the animal in a manner that prevents the spread of diseases, toxic substances and vectors;
3. The permit holder keeps, for two years after the movement of the animal or thing,  a copy of the permit and a record of the date of movement and the name and address of the place from which the animal is moved, as well as the quantity or volume of the animals;
4. The permit holder makes that copy and those records available for inspection by a CFIA inspector on request;
5. The animal to be covered by this permit is not under any other movement restriction imposed under a law of Canada or a province, and is not intended for destruction for disease control purposes;
6. The animal described in Section C that is a live gamete or a live fertilized egg is cryopreserved in a medium that is free of any of the reportable diseases and vectors or the medium is treated in a manner that removes or inactivates any of the reportable diseases and vectors;
7. The broodstock animals, from which the animal described in Section C is derived, are not vaccinated for any of the reportable diseases if the vaccine will interfere with the determination of the reportable disease status of the animal by a CFIA Inspector;
8. The animal described in Section C must not come into direct or indirect contact with any animal that is not part of the population for which the reportable disease status has been established from the time of inspection of the broodstock animals by the CFIA until the animal described in Section C is moved;
9. A representative sample from broodstock animals that the animal described in Section C was derived from was taken by the CFIA, submitted for testing by NAAHLS^Footnote 2, and determined by the CFIA to be negative for any of the reportable diseases;
10. The broodstock animals were inspected by the CFIA at the time of sampling for clinical signs and/or lesions of any of the reportable diseases and none were observed;
11. The permit holder must notify the CFIA of any morbidity shown by or mortality of the broodstock animals that can be attributed to any of the reportable diseases after inspection by the CFIA but prior to the shipment of the animal described in Section C;
12. The animal described in Section C that is a fertilized or eyed egg, live or dead, or the animal described in Section C that is a dead unfertilized egg must be decontaminated in a manner that will inactivate or remove any of the reportable diseases and vectors prior to the movement according to a CFIA-recognized protocol. The permit holder must notify the CFIA if any deviation in the protocol occurs;
13. The shipping container, animal holding unit, shipping material, equipment and conveyance to be used during the movement are new or are decontaminated in a manner that removes or inactivates any of the reportable diseases and vectors;
14. The new or decontaminated shipping container, animal holding unit, shipping material, equipment and conveyance must not come into direct or indirect contact with an animal or thing that will not be moved to the location of the destination described in Section B;
15. The water, including ice, or other medium used during the shipment is free of any of the reportable diseases and vectors or is treated in a manner that removes or inactivates any of the reportable diseases and vectors.

Permit Conditions if you Send Finfish or Molluscs (post-hatch life stage) from your Research Facility that Requires Segregation, Inspection and Testing

Please note that not all the permit conditions will apply as some depend on the type of animal being sent.

1. The disease status of the area of origin that is named in this permit does not change between the time of issuance of this permit and the time of the movement;
2. The permit holder controls and handles the movement of the animal in a manner that prevents the spread of diseases, toxic substances and vectors;
3. The permit holder keeps, for two years after the movement of the animal,  a copy of the permit and a record of the date of movement and the name and address of the place from which the animal is moved, as well as the quantity or volume of the animals;
4. The permit holder makes that copy and those records  available for inspection by a CFIA inspector on request;
5. The animal to be covered by this permit is not under any other movement restriction imposed under a law of Canada or a province, and is not intended for destruction for disease control purposes;
6. The animal described in Section C that is a mollusc has been reared since fertilization under a documented preventive control plan^Footnote 3 with measures that prevent the introduction of any of the reportable diseases to that animal and the measures are implemented.
7. The animal described in Section C is not vaccinated for any of the reportable diseases if the vaccine will interfere with the determination of the reportable disease status of the vaccinated animal by a CFIA Inspector.
8. The animal that moves under this permit must not come into direct or indirect contact with any animal that is not part of the population for which the reportable disease status has been established from the time of inspection by the CFIA until the animal is moved.
9. A representative sample from the population of animals that is to be moved under this permit was taken by the CFIA, submitted for testing by NAAHLS^Footnote 4, and determined by the CFIA to be negative for any of the reportable diseases.
10. The population of animals that is to be moved under this permit was inspected by the CFIA at the time of sampling for clinical signs and/or lesions of any of the reportable diseases and none were observed.
11. The permit holder must notify the CFIA of any morbidity shown by or mortality of the animal noticed after the inspection by the CFIA but prior to the movement of the animal that can be attributed to a reportable disease.
12. The shipping container, animal holding unit, shipping material, equipment and conveyance used during the movement are new or are decontaminated in a manner that removes or inactivates any of the reportable diseases and vectors.
13. The new or decontaminated shipping container, animal holding unit, shipping material, equipment and conveyance must not come into direct or indirect contact with an animal or thing that will not be moved to the location of the destination described in Section B.
14. The water, including ice, used during the shipment is free of any of the reportable diseases and vectors or is treated in a manner that removes or inactivates any of the reportable diseases and vectors.

Permit Conditions if you Send Things from a Research Facility

1. The disease status of the area of origin that is named in this permit does not change between the time of issuance of this permit and the time of the movement;
2. The permit holder controls and handles the movement of the thing in a manner that prevents the spread of diseases, toxic substances and vectors;
3. The permit holder keeps, for two years after the movement of the thing,  a copy of the permit and a record of the date of movement and the name and address of the place from which the thing is moved, as well as the quantity or volume of the things;
4. The permit holder makes that copy and those records  available for inspection by a CFIA inspector on request;
5. The thing to be covered by this permit is not under any other movement restriction imposed under a law of Canada or a province, and is not intended for destruction for disease control purposes;
6. The thing described in Section C is decontaminated for any of the reportable diseases and vectors in a manner that removes or inactivates any of the reportable diseases and vectors prior to the movement according to a CFIA-recognized protocol. The permit holder must notify the CFIA if any deviation in the protocol occurs.
7. After decontamination, the thing described in Section C must not come into direct or indirect contact with an animal, or with a thing that was not decontaminated.
8. The shipping container, shipping material, equipment and conveyance used during the movement of the thing described in Section C are new, or are decontaminated prior to the movement in a manner that removes or inactivates any of the reportable diseases and vectors.
9. The new or decontaminated shipping container, shipping material, equipment and conveyance must not come into direct or indirect contact with an animal or thing that will not be moved to the location of the destination described in Section B.

How to comply with the permit conditions

Preventive control plan

Before the CFIA issues a permit, a CFIA inspector will work with the research facility (for example, an aquatic animal holding/rearing facility for experimentation) to verify that the facility can meet the permit conditions, and to verify ongoing compliance with the permit conditions during the period of time that the permit is valid. The CFIA may inspect documents and records, the physical layout of the facility, and how it operates in order to assess the facility's ability to meet and comply with the permit conditions.

Research facilities that do not conduct specific work on the reportable diseases or will not be keeping live animals for study will need to have a documented preventive control plan that addresses biocontainment of: the introduced finfish or molluscs, including their carcasses or tissues and all shipping materials; effluent generated by the facility; fomites; and vectors. Researchers should use the standards in the Containment Standards for Facilities Handling Aquatic Animal Pathogens – First Edition to help prepare their plan.

In order to meet the condition for a preventive control plan, the research facility that conducts in vitro or in vivo work with the reportable diseases or will be keeping live finfish or molluscs for study will need a Compliance Letter or a Certification Letter from the CFIA's Office of Biohazard Containment and Safety (OBCS).

• A Compliance Letter is issued for either a research facility that is a "dry laboratory" (that does not work with live aquatic animals) or a research facility that is a "wet laboratory" (that works with live aquatic animals but generates small volumes of waste effluent water to be decontaminated per day).
• A Certification Letter is required for a research facility that is a "wet laboratory" that works with live aquatic animals and generates large volumes of waste effluent water to be decontaminated per day.

Research facilities that do not already have either a Compliance or Certification Letter from the OBCS will need to apply.

The following are examples of ways to comply with specific permit conditions:

Inspection and sampling of finfish and carcasses

• Make an appointment with the CFIA Inspector and provide inventory and location information of all the animals or carcasses to be inspected and sampled. Several appointments may be required if broodstock are to be inspected and sampled. If broodstock are sampled because their germplasm or fertilized eggs are to be moved, milt or ovarian fluid will be collected from ALL the broodstock that contribute to the pre-hatch population to be moved.
• Make sure the finfish or finfish carcasses to be moved under the permit are segregated from those that will not be moved. This can be done right after the inspection or when the fertilized eggs are placed in the incubators. Sampled broodstock that will not be moved under the permit do not require segregation but their location must be known so that they can continue to be observed for signs of disease.
• Make sure that staff can assist in the process and provide all equipment required to gain access to the animals or carcasses for selection of samples by the CFIA. Expect that finfish and carcasses will be sampled from each holding unit (or a selection of them if there are many).
• Note, during the first year of this program (December 31, 2015 to December 31, 2016), the CFIA may accept test results associated with certification under the Fish Health Protection Regulations. If the finfish or carcasses to be moved were tested during that time period by DFO, ask for a derogation of the testing and segregation permit conditions when you apply for a movement permit, and check the Derogation box in Section A of the application form.

Non-interference of vaccines with testing results

• If a vaccine against a declared disease has been used, please provide information that demonstrates the vaccine will not affect test results. The vaccine company should be able to provide this information.
• If the vaccine company cannot provide this information, then search for research articles.
• If there is no available information, the permit will not be issued and those animals can only be moved to destinations where a permit is not required from the CFIA.

Egg decontamination protocol

• Submit a written protocol to the CFIA.
• Depending on the disinfectant used, the protocol should be consistent with manufacturer's recommendations.
• For decontamination of newly fertilized or eyed salmon and trout eggs, the protocol should be consistent with current World Organisation for Animal Health (WOAH; founded as Office International des Épizooties (OIE)) recommendations.
• If international or manufacturer's recommendations are not suitable for the finfish species, another protocol should be documented with available scientific evidence that demonstrates the efficacy of the disinfectant. The CFIA may conduct a scientific evaluation of the protocol before issuing a permit.

Decontamination protocol for a thing (fomite)

• Submit a written protocol to the CFIA. The protocol for decontamination typically includes:
  • a procedure for cleaning the thing prior to disinfection if required,
  • rinsing the thing after cleaning if required,
  • applying the disinfectant, and
  • rinsing the thing after disinfection if required.
• Consider the following items, as appropriate:
  • cleaner compatibility with the disinfectant,
  • efficacy of the disinfectant for the declared disease(s) in the area (dose and contact time),
  • proper storage of the disinfectant,
  • not using expired product, and
  • water quality parameters that need to be taken into account when diluting the disinfectant (for example, temperature and pH).

These considerations are usually addressed in the manufacturer's directions for use but you will need to provide written notes to explain any deviation from recommended directions. The CFIA may conduct a scientific evaluation of the protocol before issuing a permit.

General information related to movements

The permit and its conditions may be amended only by the Minister of Agriculture and Agri-Food or by an inspector who is designated for the purposes of the Health of Animals Act. The permit and its conditions may not be amended with respect to a specific movement after it has already occurred. If an amendment is required to a valid movement permit that has already been issued under this program, or if a change to permit conditions is desired, submit a new application and check the Amendment or Derogation box in Section A.

The permit holder must meet all of the conditions specified in documents attached to the permit, or else the movement of the animal or thing is not permitted. The permit holder is also required to notify the CFIA when they suspect or detect any reportable disease in an animal.

The CFIA may dispose of an animal or thing, or order that it be disposed of, when it:

• is suspected of being affected or contaminated by a disease or toxic substance;
• has been in contact with an animal or thing that is, or is suspected of being affected or contaminated by a disease or toxic substance; or
• is suspected of being a vector or the causative agent of a disease or a toxic substance.

The CFIA inspector may also order that that an animal or thing be treated if they consider that the treatment will effectively eliminate the disease or prevent it from spreading. Although compensation may be awarded in respect of disposal or treatment costs, the Government of Canada is not liable for any costs incurred by a person required to do anything under the legislation respecting the health of animals.

If a designated animal is moved into an area that either violates the conditions of the permit or contravenes the Health of Animals Act or Health of Animals Regulations, the CFIA may order the animal returned without delay to the area from which it was moved or to an area of equal or lesser health status.

Those who transport live aquatic animals by air should comply with the International Air Transport Association (IATA) Live Animals Regulations, approved by the World Organization for Animal Health (WOAH). For all forms of transport, suitable arrangements must be made for water quality, ambient temperature, oxygenation and general care of the animal during transportation. An animal must be fit to be transported and should not suffer stress that renders them infirm, ill, injured or fatigued during the journey.

The permit and its conditions cover all persons who are moving the animal or thing on behalf of the permit holder. The permit holder remains responsible for the shipment's continued compliance with the conditions of the permit.

Important definitions

Culture:

refers to the end use of keeping or holding of live aquatic animals for sale, or enhancement, restoration or stocking that may or may not employ some method of intervention in the process, such as feeding or collection of germplasm. This definition excludes live aquatic animals kept in aquaria for the end use of education, display or retail (private or public).

Decontamination:

refers to the process of cleaning and/or disinfection of a fomite or the surface of eggs of aquatic animals to remove or inactivate the declared diseases.

Depuration:

means the process of using a controlled aquatic environment to reduce the level of bacteria and viruses in live molluscs.

Dry Storage:

means the storage of live molluscs out of water.

Enhancement:

means live finfish that will be put directly into natural waterways, including the territorial seas and contiguous zones for the purpose of augmenting commercial fisheries.

Feed for Finfish:

refers to the end use of feeding live or dead finfish, including finfish germplasm or fertilized eggs, directly to live finfish.

Fomite:

refers to an inanimate object capable of transmitting a disease.

Processing Commercial:

refers to the end use of processing of live molluscs at a federally-registered establishment and intended for human consumption. This definition includes the activities of depuration, dry storage, short-term container relaying, and wet storage.

Relay:

means the transfer of molluscs from marginally contaminated areas to approved areas for natural biological cleansing, using the ambient environment as a treatment system for periods of 14 days or greater. Areas are approved by Fisheries and Oceans Canada (DFO).

Release into Natural Waterways:

means the end use of release of live aquatic animals into the Canadian fisheries waters and the contiguous zone of Canada. This definition does not include aquatic animals that are kept or held in the natural waterways. Canadian fisheries waters means all waters in the fishing zones of Canada, all waters in the territorial sea of Canada and all internal waters of Canada (section 2 of the Fisheries Act).

Repair:

includes maintenance.

Research:

refers to the end use of aquatic animals, aquatic animal carcasses or things for scientific research or experimentation.

Restoration:

means live finfish that will be put directly into natural waterways, including the territorial seas and contiguous zones, for the purpose of bringing back a species into the ecosystem; the purpose may include restoration of recreational or commercial fishing opportunities.

Salting Up:

means the transfer of molluscs from low salinity growing areas to high salinity growing areas to improve the growth and marketability of the mollusc for human consumption. Synonym: High Salinity Relay.

Short-term Container Relaying:

means the transfer of live molluscs from marginally contaminated areas to approved areas for natural biological cleansing in a container using the ambient environment as a treatment system for periods of less than 14 days.

Stocking:

means live finfish that will be put directly into natural waterways, including the territorial seas and contiguous zones or ponds with access to natural waterways, for the purpose of augmenting recreational fishing.

Vector:

refers to a living animal that has the potential to transmit a disease, directly or indirectly, from one animal or its excreta to another animal.

Wet Storage:

means the temporary storage (less than 60 days) of live molluscs from approved sources (harvest sites are approved by Fisheries and Oceans Canada (DFO)), intended for marketing, in containers or floats in natural bodies of seawater or in tanks containing natural or synthetic seawater.