Frequently Asked Questions
Containment Standards for Facilities Handling Aquatic Animal Pathogens

Q1. Who does the Containment Standards for Facilities Handling Aquatic Animal Pathogens apply to?

The Aquatic Standards apply to facilities importing aquatic animal pathogens, aquatic animal product(s) and by-product(s) or other substances that may carry an aquatic animal pathogen or part thereof. The Aquatic Standards are primarily intended to address facilities importing aquatic animal pathogens, but may also be used as a resource for the design and operating requirements for any aquatic animal containment facility.

Q2. Who participated in the development of the Containment Standards for Facilities Handling Aquatic Animal Pathogens?

The CFIA's Office of Biohazard Containment and Safety (OBCS) assumed the lead role for the development of the Aquatic Standards within the CFIA as they are responsible for the importation programs for terrestrial and aquatic animal pathogens as well as for the certification of facilities that handle imported terrestrial, aquatic and plant pathogens.

The Aquatic Standards were developed in collaboration with the Aquatic Animal Health Division and the Canadian Centre for Veterinary Biologics (CCVB) 1. The Standards were then reviewed by a group of multidisciplinary experts from the CFIA, the Department of Fisheries and Oceans (DFO), the Canadian Council on Animal Care, the Public Health Agency of Canada, selected universities and private industry with experience in aquatic animal pathogen containment.

Q3. What is the purpose of the Containment Standards for Facilities Handling Aquatic Animal Pathogens?

The Aquatic Standards describe the physical and operational requirements for facilities working with imported aquatic animal pathogens. Three containment levels are described in detail; Aquatic Containment level 1 (AQC1), AQC2 and AQC3 with both in vivo and in vitro applications. In order to remain consistent with the containment standards for facilities handling human and terrestrial animal pathogens, a fourth level (AQC4) is mentioned, though not described in detail because there are currently no corresponding pathogens that meet the criteria for this level of containment.

Q4. How will the implementation of the Containment Standards for Facilities Handling Aquatic Animal Pathogens affect my operations?

The Aquatic Standards describe the physical and operational requirements for facilities that have imported or plan to import and are subsequently working with aquatic animal pathogens. If you currently operate a facility which handles imported aquatic animal pathogens, physical or operational enhancements to your facility may be required before you can import aquatic animal pathogens in the future. It is also important to note that while the Aquatic Standards are primarily intended to address facilities importing aquatic animal pathogens, they may also be used as a resource for the design and operating requirements for any aquatic animal containment facility.

Q5. Why does my facility need to meet the physical and operational requirements of the Containment Standards for Facilities Handling Aquatic Animal Pathogens?

The CFIA, under the authority of the Health of Animals Act and associated regulations, strives to protect aquatic life and the aquaculture sectors of the Canadian economy by regulating the importation, exportation and preventing the spread of aquatic animal diseases in Canada. The Health of Animals Act and associated regulations authorize the CFIA to prohibit or restrict the movement of aquatic animal pathogens, aquatic animal product(s) and by-product(s) or other substances that may carry an aquatic animal pathogen or part thereof into Canada. This effort includes the need to contain and control imported aquatic animal pathogens that are being used for research purposes.

Q6. What is the process to obtain an aquatic animal pathogen import permit?

To obtain an import permit, an application form - PDF (770 kb) must be completed and submitted to CFIA's Office of Biohazard Containment and Safety (OBCS). For further information please consult the import procedures and the Frequently Asked Questions on the OBCS Animal Pathogen Import Program web pages.

Q7. Can an aquatic animal pathogen/product acquired with an import permit be transferred to another laboratory or facility within Canada?

As indicated on the original import permit, an imported animal pathogen/product can only be transferred to another facility with the approval of the Office of Biohazard Containment and Safety. To receive a transfer letter, which permits the relocation of the imported animal pathogen/product to another laboratory or facility, please contact importzoopath@inspection.gc.ca.

Q8. Can an aquatic animal pathogen/product acquired by an import permit for in vitro purposes also be used for in vivo applications?

An imported aquatic animal pathogen/product must only be used for the purposes intended on the original import permit. If the original import permit was issued for a pathogen to be used in vitro then an amendment must be made in order to add in vivo applications. Please contact importzoopath@inspection.gc.ca to make any amendments regarding the end use of a previously imported aquatic animal pathogen.

Q9. How is the risk group level determined for aquatic animal pathogens?

As aquatic animal pathogen import permit applications are received, the CFIA assesses the risks associated with the pathogen and determines the appropriate risk group level (i.e., RG1-RG4) of the aquatic animal pathogen. The risk group level is an internationally accepted term used for the inherent risks of a pathogen that are based on factors such as the severity of disease caused, routes of infection, virulence and infectivity. It also takes into account the existence of effective therapies, possibilities for immunization, presence of vectors, quantity of agent, whether the agent is indigenous to Canada, possible effects on other species, and possible economic/environmental effects.

The containment level is then determined based on the pathogen risk group level and the associated work to be done with the pathogen. The risk group level and containment level may not necessarily be the same, but the containment level must always be the same level or higher than the risk group level of the particular pathogen. As an example, a RG2 level pathogen can be handled in an AQC2 or AQC3 facility but never in an AQC1 facility.

Q10. Will there be an aquatic animal pathogens risk group level list provided to stakeholders?

As with other similar containment standards published for terrestrial animal pathogens, human pathogens and plant pests, risk group level lists are not provided in published format. If you require information on the classification of a particular aquatic animal pathogen, please do not hesitate to contact importzoopath@inspection.gc.ca.

Q11. How are the required Aquatic Containment (AQC) levels determined?

The required containment level and the stringency of operational practices are based on an evaluation of the hazards and risks posed by the aquatic animal pathogens, the proposed activities involving the pathogens, and mitigating measures. In the case of live aquatic animal holding facilities (also referred to as in vivo facilities), consideration is given to the facility's physical characteristics and also to the pathogen itself in determining the containment level required. A list of potential risk assessment criteria is provided in Chapter 2 of the Aquatic Standards. It is important to note that the containment level for many aquatic animal pathogens increases when the pathogen will be used in vivo.

Q12. What is the process to obtain certification?

Ifyou currently operate a facility which handles aquatic animal pathogens or if you are building a new facility, please contact the Office of Biohazard Containment and Safety (OBCS) early in the planning phase at biocon@inspection.gc.ca. Please complete Form A-AQ which provides the OBCS with details on the facility such as the address, the contact information, the program intent and the workobjectives.Oncethis form is returned to the OBCS, a Biosafety Specialist will review the information provided to determine the required Aquatic Containment (AQC) level and provide recommendations on how to attain the desired AQC level.

Certification will be valid for a period of one year. If a facility is not granted certification, or certification is revoked for any reason, the deficiencies must be corrected before the facility can be certified or re-certified. For more information, contact us at biocon@inspection.gc.ca .

Q13. How much does certification cost?

Currently there is no fee for facility certification or re-certification.

Q14. I am building a new facility where aquatic animal pathogens will be handled, and would like to know when I should contact the CFIA?

Please contact us early in the planning phase at biocon@inspection.gc.ca . Working collaboratively with the Office of Biohazard Containment and Safety will help ensure compliance with the appropriate requirements, and should reduce delays in the certification of your facility.

Q15. Which operational practices in Chapter 4 do facilities have to comply with?

The operational practices outlined in Chapter 4 are the general operational practices for work carried out in research and diagnostic laboratories as well as live animal holding facilities. Facilities are required to comply with the operational practices corresponding to the assigned physical containment level of their facility. The operational practices outlined in sections 4.1 through 4.3 are cumulative. Section 4.4 outlines the requirements that in vivo facilities must comply with in addition to those described in the previous sections. As an example, an AQC2 in vivo facility would have to comply with sections 4.1, 4.2 and 4.4.

Q16. How will the Containment Standards for Facilities Handling Aquatic Animal Pathogens affect aquatic pathogen aquaculture vaccine production and testing facilities?

The CFIA's Canadian Centre for Veterinary Biologics (CCVB) 1 is responsible for regulating veterinary biologics in Canada under the Health of Animals Act and associated regulations. Written authorization must be obtained from CCVB prior to the introduction of a new aquatic animal pathogen into veterinary biologics production, testing, research and development facilities. A Permit to Release Veterinary Biologics must be obtained from CCVB prior to the release of an unlicensed or an experimental veterinary biologic outside the containment zone. The CCVB and the Office of Biohazard Containment and Safety will collaborate when an aquatic facility is handling veterinary biologics and requires certification.

Q17. Does the Containment Standards for Facilities Handling Aquatic Animal Pathogens apply to facilities working with pathogens that affect marine mammals?

Work involving imported animal pathogens that affect marine mammals will be assessed on a case-by-case basis. Neither the Aquatic Standards nor the Containment Standards for Veterinary Facilities pertain specifically to the unique containment requirements of marine mammals but a combination of the requirements from each Standard may be applicable. When a pathogen that affects a marine mammal is requested for import, our Biosafety Specialists assess the hazards and risks posed by the animal pathogen, the proposed activities involving the pathogen, and mitigating measures in order to determine the appropriate containment requirements. These specific requirements will be listed as conditions on your animal pathogen import permit.

1. Formally known as CFIA's Veterinary Biologics Section (VBS).