Questions and Answers - Containment Standards for Facilities Handling Aquatic Animal Pathogens

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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.

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.

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.

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.

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.

What is the process to obtain certification?

I fyou 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.

How much does certification cost?

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

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.

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) 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.

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