Industry Guidance for Laboratories

Laboratories in Canada that import aquatic animals or infectious materials with aquatic animal disease agents into Canada already require an import permit from the CFIA. Similar requirements are now necessary for movement of aquatic animals or infectious materials to laboratories within Canada.

The following is guidance for laboratories that:

1. will regularly receive declared wild or cultured aquatic animals, live or dead, or a reportable aquatic animal disease agent for the purpose of diagnostic testing or other testing AND
2. are not located in an infected area for at least one of the declared diseases.

Laboratories that may require a permit include those that perform:

• diagnostic testing for a declared reportable aquatic animal disease
• testing for a declared reportable aquatic animal disease for research studies
• testing on aquatic animals or their fluids, organs or tissues for other reasons^Footnote 1 than the declared reportable aquatic animal diseases

Laboratories that will be receiving aquatic animals or things from infected or buffer areas must

• be a Closed Premises (biosecure facility); and
• use the Application for a Movement Permit to a Closed Premises (CFIA/ACIA 5749) - PDF (154 kb).

Currently, permits may be valid for one or two years. To reapply for a permit, laboratories must use the same application form as above and check the Renewal box in Section A.

Additional information:

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

Permit conditions to receive animals and things

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 2 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.

How to comply with the permit conditions

Before the CFIA issues a permit, a CFIA inspector will work with the applicant to verify that the laboratory can meet the permit conditions, and to verify the laboratory's ongoing compliance with the permit conditions during the time that the permit is valid. The CFIA may inspect documents and records, the physical layout of the laboratory, and how it operates in order to assess the laboratory's ability to meet and comply with the permit conditions.

Laboratories that do not conduct specific work on the reportable diseases and will not be keeping live finfish or molluscs for their work 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 laboratory rooms handling the animals, carcasses or tissues; fomites; and vectors. Laboratories 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 laboratory that conducts in vitro or in vivo work with the declared reportable diseases, or laboratories that will be keeping live animals for any type of testing activities 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 laboratory that is a "dry laboratory" (that does not work with live aquatic animals) or a laboratory that is a "wet laboratory" (that works with live aquatic animals but generates smaller volumes of waste effluent water to be decontaminated per day).
• A Certification Letter is required for a "wet laboratory" that works with live aquatic animals and generates larger volumes of waste effluent water to be decontaminated per day.

Laboratories that do not already have either a Compliance or Certification Letter from the OBCS will need to apply. Should the OBCS not be able to provide the laboratory with a Compliance Letter in the first year of this program (December 31, 2015 to December 31, 2016), a CFIA veterinary inspector in the laboratory's area may determine whether the laboratory can comply with the permit condition for a preventive control plan. This decision will be based on the laboratory's consistency with the Containment Standards for Facilities Handling Aquatic Animal Pathogens - First Edition. The laboratory should use the standards to prepare their preventive control plan.

Other examples how laboratories may comply with permit conditions include^Footnote 3:

• In order to meet the condition of safe transport of potentially infected/contaminated animals or things to the laboratory, the laboratory can provide written packaging documentation to clients that describes the use of new or decontaminated containers for shipping, and leak-proof and impact-resistant packaging that prevents the contents from escaping or leaking.
• In order to meet the condition of knowledge of any movement restrictions/destruction orders for disease control purposes, the laboratory can ask clients to attest on the laboratory submission form that the animals or things they are sending are not under any restrictions or destruction orders.

For more information on how to comply with these and other permit conditions, contact the CFIA Area Office closest to the laboratory.

General information related to movements of animals and things to your laboratory

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 Organisation for Animal Health (WOAH; founded as Office International des Épizooties (OIE)). 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

Diagnostic Testing

refers to the end use of aquatic animals (or parts derived from live or dead animals, such as blood), or other things for the purpose of testing for diseases of aquatic animals.

Other Testing

refers to the end use of live aquatic animals or their carcasses, or parts derived from live or dead aquatic animals, for testing for other purposes than detection of diseases of aquatic animals, for example, for nutrients and toxins;

refers to the end use of freshwater sediments, or derivatives from freshwater sediments, for testing for other purposes than detection of diseases of aquatic animals, for example, for biological oxygen demand and toxins.