Frequently asked questions - development of the Canadian Biosafety Standards and Guidelines

General

1. How does the Canadian Biosafety Standard (CBS) relate to the Human Pathogens and Toxins Act (HPTA)?

The CBS 2nd Edition came into effect on December 1, 2015, and was coordinated with, and corresponds to, the full implementation of the HPTA and the Human Pathogens and Toxins Regulations (HPTR).

2. Why are only human and terrestrial animal pathogens included?

The requirements to safely handle and store human and terrestrial animal pathogens are very similar to each other and for this reason the Public Health Agency of Canada and the Canadian Food Inspection Agency (CFIA) worked together to streamline biosafety practices into a single set of standards and guidelines for stakeholders regulated by both agencies.

Although only a few aquatic animal pathogens are considered to be zoonotic, a select few are considered opportunistic and may pose a low direct risk to personnel. To specifically address the unique physical and operational requirements for safely handling aquatic animal pathogens, aquatic animal products and by-products or other substances that may carry an aquatic animal pathogen or part thereof, in 2010, the CFIA released the Containment Standards for Facilities Handling Aquatic Animal Pathogens.

Plant pests almost never infect or infest healthy people, and therefore pose little direct risk to laboratory personnel. Some can, however, pose a significant threat to agricultural production, forests and natural environments and adequate containment to prevent the accidental escape of potentially damaging pests into the environment is essential. To specifically address the unique physical and operational requirements for safely handling plant pests other than weeds, soil, genetically modified plants and arthropod biological control agents, in 2009, the CFIA released the Containment Standards for Facilities Handling Plant Pests.

3. How was the responsibility divided between the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) on this project?

The two agencies collaborated equally though all aspects of the Canadian Biosafety Standard (CBS) and Canadian Biosafety Handbook (CBH) development, including the decision making process. The two agencies will continue to work together to develop future editions, as the CBS and CBH will always be joint documents.

4. Which types of facilities are required to comply with the Canadian Biosafety Standard (CBS)?

The CBS applies to any facility in Canada where controlled activities with human pathogens or toxins have been authorized by a licence under the Human Pathogens and Toxins Act, as well as any facility authorized to import or transfer an a terrestrial animal pathogen from another country by a permit to import an animal pathogen in accordance with Section 51(a) or (b) of the Health of Animals Regulations.

5. Have the physical and operational requirements changed in the Canadian Biosafety Standard (CBS)?

The CBS, 2nd Edition, continues the vision of the Canadian Biosafety Standards and Guidelines (CBSG), 1st Edition, by updating several requirements in a risk-, performance-, and evidence-based approach, but to allow facilities more versatility in compliance. Updates were made to incorporate new information in the field of biocontainment engineering, where possible, as well as information to support the full implementation of the Human Pathogens and Toxins Act (HPTA) and the Human Pathogens and Toxins Regulations (HPTR).

6. Will this enhance safety in facilities where work with human and terrestrial animal pathogens, prions, and biological toxins is being conducted?

The safe and secure handling of biohazardous materials, the prevention of laboratory acquired infections/intoxications, and the inadvertent release of pathogens or toxins from containment zones, which could potentially pose significant risks to the health of humans or animals, or the environment remain the main objectives of the Canadian Biosafety Standard (CBS), 2nd Edition. The CBS achieves this by outlining the most recent physical and operational requirements to be used to design and operate facilities where activities are conducted with human and/or terrestrial animal pathogens.

A clear, evidence based and up-to-date CBSG will make it easier for personnel to understand and comply with the requirements, and decrease the risks posed to public health and safety by these pathogens.

7. Will the implementation of the Canadian Biosafety Standard (CBS), 2nd Edition, have an effect on the health of the general public and the domestic animal population?

The CBS provides the minimum requirements to safely handle and contain human and terrestrial animal pathogens in a containment facility, which will reduce the likelihood of their inadvertent release and any subsequent adverse health effects on the general public, or the domestic animal population, caused by their release.

Application of the Canadian Biosafety Standard, Canadian Biosafety Handbook, and Canadian Biosafety Guidelines

8. When did the Canadian Biosafety Standard (CBS), 2nd Edition, first edition come into effect?

The CBS, 2nd edition was published on March 11th, 2015, at the same time as the final Human Pathogens and Toxins Regulations (HPTR) were published in the Canada Gazette II. The CBS came into effect on December 1st, 2015, and replaced the Canadian Biosafety Standards and Guidelines (CBSG), 1st Edition. This was coordinated with the day that the HPTR came into force and the Human Pathogens and Toxins Act was fully implemented.

9. Will I need to apply for a new Containment Level 2 Compliance Letter once the Canadian Biosafety Standard (CBS), 2nd Edition, comes into effect?

No. The CBS came into effect on December 1st, 2015 to support the full implementation of the Human Pathogens and Toxins Act (HPTA) and the Human Pathogens and Toxins Regulations (HPTR). At the same time, the Human Pathogens Importation Regulations (HPIR) were repealed. Containment Level 2 Compliance Letters issued by the Public Health Agency of Canada to confirm compliance under the HPIR are no longer be issued beyond December 1st, 2015. From December 1st, 2015, a person conducting controlled activities with human pathogens or toxins is required to apply for a licence under the HPTA. The Canadian Food Inspection Agency (CFIA) may request supplementary information from facilities requesting a permit to import animal pathogens into Canada.

Information on the process to apply for a licence for controlled activities is available on PHAC's website. Information on the process to apply for a permit to import animal pathogens from the CFIA is available on CFIA's website.

10. Will I require a new certification letter for my Containment Level 3 (CL3), Containment Level 4 (CL4) or Prion facilities once the Canadian Biosafety Standard (CBS) 2nd edition comes into effect?

The CBS came into effect on December 1st, 2015 to support the full implementation of the Human Pathogens and Toxins Act (HPTA) and the Human Pathogens and Toxins Regulations (HPTR). As the HPTA requires that a person conducting controlled activities with human pathogens and toxins obtains a licence, the Public Health Agency will no longer certify Containment Level 3 or 4 facilities. However, the Canadian Food Inspection Agency (CFIA) will continue to certify CL3 and CL4 facilities requesting a permit to import animal pathogens into Canada.

Information on the process to apply for a licence for controlled activities is available on PHAC's website. Information on the process to apply for a permit to import animal pathogens from the CFIA is available on CFIA's website.

11. Which requirements do I have to follow in the Canadian Biosafety Handbook (CBH), 2nd Edition?

The CBH is a companion guidance document to the Canadian Biosafety Standard (CBS), 2nd Edition that provides the core information and guidance on how the biosafety requirements outlined in the CBS can be achieved. The CBH does not include or establish additional requirements, but does provide examples and recommendations that may be followed.

12. Do I have to follow the requirements in the Canadian Biosafety Guidelines?

The Canadian Biosafety Guidelines are a series of biosafety and biosecurity themed guidance documents that expand upon a variety of biosafety concepts in the Canadian Biosafety Handbook (CBH), 2nd Edition. These guidelines aim to provide stakeholders with further support and guidance on specific topics that goes into greater depth than the CBH. These guidelines provide recommendations only that can be implemented on a voluntary basis.

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