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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 CBH systematically addresses the concepts required for the development and maintenance of a comprehensive risk-based biosafety management program. 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 Guidelines originally published as Part II of the CBSG have also been updated and are published in the Canadian Biosafety Handbook (CBH), 2 nd Edition, 2015. This will support licence applications, renewals, animal pathogen import permit applications, and, where applicable, the facility certification (and recertification) of containment zones. The CBS will be used by the PHAC and the CFIA to verify the ongoing compliance of regulated facilities with the applicable legislation. On December 1 st, 2015, the HPTR comes into force and the CBS will come into effect and supersede the CBSG.
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In addition, the CBS includes several new requirements and information to support the full implementation of the HPTA and the HPTR. 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.
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The CBS sets out the physical containment, operational practice, and performance and verification testing requirements for the safe handling or storing of human and terrestrial animal pathogens and toxins. Prions: Containment Standards for Laboratories, Animal Facilities and Post Mortem Rooms Handling Prion Disease Agents, 1 st Edition, 2005 (CFIA).Terrestrial animal pathogens: Containment Standards for Veterinary Facilities, 1 st Edition, 1996 (CFIA).Human pathogens and toxins: Laboratory Biosafety Guidelines, 3 rd Edition, 2004 (PHAC).
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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 second edition of the CBS updates the biosafety standard originally published as Part I of the Canadian Biosafety Standards and Guidelines (CBSG), 1 st Edition, 2013. 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 Government of Canada's Canadian Biosafety Standard (CBS), 2 nd Edition, 2015, is a harmonized national standard for the handling or storing of human and terrestrial animal pathogens and toxins in Canada. 5.3 Performance and Verification Tests to be Conducted on Commissioning of Containment Zone.5.2 Additional Performance and Verification Tests for Select CL2 and CL2- Ag Zones and All C元-CL4 Zones.5.1 Performance and Verification Tests for All Containment Levels.Chapter 5 - Performance and Verification Testing Requirements.
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4.8 Decontamination and Waste Management.4.5 Entry and Exit of Personnel, Animals, and Material.Chapter 4 - Operational Practice Requirements.Chapter 3 - Physical Containment Requirements.2.6 Matrix Layout: Chapters 3, 4, and 5.
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Chapter 2 - How to Use the Canadian Biosafety Standard.1.4 Legislative and Regulatory Requirements for Animal Pathogens, Toxins, and other Regulated Infectious Material.1.3 Legislative and Regulatory Requirements for Human Pathogens and Toxins.