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Draft Second Edition June 4th, 2014
The Government of Canada's Canadian Biosafety Standard (CBS), 2nd Edition, 2015, is a harmonized national standard for the handling and storing of human and terrestrial animal pathogens and toxins in Canada. Activities in Canada involving human and animal pathogens and toxins are regulated by the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) in accordance with the Human Pathogens and Toxins Act (HPTA), the Human Pathogens and Toxins Regulations (HPTR), the Health of Animals Act, and the Health of Animals Regulations.
The second edition of the CBS updates the biosafety standard originally published as Part I of the Canadian Biosafety Standards and Guidelines (CBSG), 1st Edition, 2013. The CBSG was developed to update and harmonize three existing Canadian biosafety standards and guidelines for the design, construction, and operation of facilities in which pathogens or toxins are handled or stored:
The CBS sets out the physical containment, operational practice, and performance and verification testing requirements for the safe handling and storing of human and terrestrial animal pathogens and toxins. The CBS updates many requirements to be more risk, evidence, and performance-based, as well as incorporating new information in the field of biocontainment engineering. In addition, the CBS includes several new requirements and information to support the full implementation of the HPTA and the HPTR. On the date that the HPTR comes into force, the CBS will come into effect, and supersede the CBSG. The CBS will be used by the PHAC and the CFIA to verify the ongoing compliance of regulated facilities with the applicable legislation. This will support licence applications, renewals, animal pathogen import permit applications, and, where applicable, the certification (and recertification) of containment zones.
The Guidelines originally published as Part II of the CBSG have also been updated and are published in the Canadian Biosafety Handbook (CBH), 2nd Edition, 2015. The CBH is a companion document to the CBS that provides core information and guidance as to how the biosafety and biosecurity requirements outlined in the CBS can be achieved. The CBH systematically addresses the concepts required for the development and maintenance of a comprehensive risk-based biosafety management program. In some instances, however, best practices or risk mitigation strategies other than those described in the CBH may also be acceptable to achieve the requirements of the CBS.
The PHAC and the CFIA welcome comments, clarifications, and suggestions for incorporation into future editions of the CBS. To this end, please send information with references (where applicable) for the continual improvement of the CBS to:
American Society of Mechanical Engineers (ASME) ASME AG-1-2009, Code on Nuclear Air and Gas Treatment. ASME N511-2007, In-service Testing of Nuclear Air Treatment, Heating, Ventilating, and Air-Conditioning Systems.
National Standard of Canada (CAN)/ Canadian Standards Association (CSA) CAN/CSA B64.10-11/B64.10.1-11, Selection and Installation of Backflow Preventers/Maintenance and Field Testing of Backflow Preventers. CAN/CSA Z180.1-00 (R2010), Compressed Breathing Air and Systems.
Sheet Metal and Air Conditioning Contractors National Association, Inc. (SMACNA) HVAC Air Duct Leakage Test Manual.
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