Containment Standards for Facilities Handling Aquatic Animal Pathogens - First Edition
Chapter 1 - Introduction

1.1 Scope

This document applies to facilities^Footnote 1 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 document sets forth the minimum physical and operational requirements for facilities importing and subsequently working with aquatic animal pathogens or infectious materials. These facilities may include private, government, university establishments, research laboratories, vaccine production and vaccine testing facilities. While the Containment Standards for Facilities Handling Aquatic Animal Pathogens are mandatory for facilities importing aquatic pathogens, they also provide general guidance on the design and operating requirements for any aquatic animal containment facility.

This document will be used by Canadian Food Inspection Agency (CFIA) staff responsible for overseeing the importation of aquatic animal pathogens and for the certification of facilities in which imported aquatic animal pathogens are handled and stored. All persons wishing to import aquatic animal pathogens and related infectious materials for in vitro or in vivo work must comply with these standards along with any import requirements established by the CFIA and, where applicable, by the Public Health Agency of Canada (PHAC).

This document also serves as a resource for:

• researchers working with microorganisms for vaccine development, production and testing related to aquatic animal disease;
• researchers conducting pathogenicity/epidemiological investigations for laboratories that routinely handle aquatic animals for disease screening and diagnostics;
• commercial, academic, private and government facilities (e.g., zoos, aquariums, universities, Fisheries and Oceans Canada) working with aquatic animals that carry, or that originate from facilities, zones or countries known to be exposed to, pathogens presenting unknown or unacceptable risks to aquatic resources in the environment surrounding the holding facility.

Compliance with the requirements related to the importation of aquatic animal pathogens and the physical and operational requirements described in these standards will help to prevent the inadvertent release of economically and environmentally significant aquatic animal pathogens.

1.2 Background

Agriculture and Agri-Food Canada's Containment Standards for Veterinary Facilities, 1^st Edition^Footnote 2, 1996, is a document that sets out standards to be applied by those who design, build, operate, or work in facilities in which animal pathogens are handled. The Laboratory Biosafety Guidelines, 3^rd Edition^Footnote 3, published in 2004 by the Public Health Agency of Canada, provides similar guidance for laboratories in which human pathogens are handled. Until now, facilities carrying out aquatic animal diagnostic, research, vaccine production and vaccine testing activities were required to comply with the current version of the Containment Standards for Veterinary Facilities. However, those containment standards are not applicable in all cases to work involving aquatic animal pathogens.

Although only a few aquatic animal pathogens are considered to be zoonotic, some are considered opportunistic and therefore may pose a low direct risk to personnel. Many aquatic animal pathogens pose a significant risk of introduction and spread of infectious diseases to vulnerable aquatic animal populations in Canada. As a result, it is important that personnel working with aquatic animal pathogens and the facilities housing these organisms take steps to prevent the accidental release of potentially harmful pathogens into the aquatic environment. The containment level that is required depends on the biology of the specific pathogens involved and the impact that a release of the pathogens might have on the Canadian environment.

Until 2005, the management of aquatic animal health was regulated by Fisheries and Oceans Canada (DFO) under the Fisheries Act. However, the Fisheries Act and associated Regulations were limited in scope and not specifically designed for the management of aquatic animal diseases, leaving Canada vulnerable to impacts on wild and cultured aquatic resources. With the development and implementation of the National Aquatic Animal Health Program (NAAHP) in Canada, the CFIA is now the lead agency responsible for health management of aquatic resources in Canada. The Containment Standards for Facilities Handling Aquatic Animal Pathogens have been developed to reflect this change in regulatory authority and the corresponding requirements pertaining to the importation of aquatic animal pathogens under the Health of Animals Act and associated Regulations.

1.3 Regulatory Authorities

The Health of Animals Act and associated Regulations give the CFIA the legislative authority to control the importation of pathogens that may cause disease in animals. The CFIA has established the conditions under which imported animal pathogens are to be handled and stored. The CFIA's Office of Biohazard Containment and Safety (OBCS), in collaboration with the CFIA's Aquatic Animal Health Division (AAHD), has taken a lead role in the development and administration of the Containment Standards for Facilities Handling Aquatic Animal Pathogens. Import permits issued by the OBCS are required for the importation of all aquatic animal pathogens into Canada. For work involving zoonotic aquatic animal pathogens, the PHAC's Laboratory Biosafety Guidelines must also be followed and an import permit may be required by the PHAC under the Human Pathogens Importation Regulations.

With the development of specific containment standards for aquatic animal facilities, all facilities importing aquatic animal pathogens, infected aquatic animals or parts thereof are now required to comply with the new standards. In some instances, facilities will be required to upgrade or renovate to meet the new standards, and therefore a transition period will be part of the implementation plan. Facilities wishing to begin or to continue activities that fall within the scope of these standards must comply with the physical requirements and the operational practices described in this document.

Additional requirements apply to work conducted with veterinary biologics, including fish vaccines and in vitro diagnostic test kits for the detection of fish pathogens. The CFIA's Veterinary Biologics Section (VBS) is responsible for regulating veterinary biologics in Canada under the Health of Animals Act and associated Regulations^Footnote 4. Written authorization must be obtained from VBS 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 VBS prior to the release of an unlicensed or an experimental veterinary biologic outside the containment zone. For specific information about the regulatory requirements for veterinary biologics, please contact VBS.

For any work that involves aquatic animal pathogens that may be transmitted via the airborne route or pathogens that affect aquatic mammals, additional containment requirements may be required and will be assessed on a case-by-case basis by the CFIA.