Biosafety Directives, Advisories and Notifications

1) Biosafety directives are developed when the containment requirements for a specific pathogen or group of pathogens do not align with their risk group. Biosafety directives provide regulated parties with a comprehensive overview of the customized containment level requirements for activities with the pathogen (i.e., derogations) as well as other biosafety considerations. It is important to note that biosafety directives are to be used in conjunction with the requirements outlined in the Canadian Biosafety Standard (CBS) 2^nd edition.

• Biosafety Directive for Mycobacterium tuberculosis complex (MTBC) (July 18, 2014)

  The Public Health Agency of Canada has developed a biosafety directive for laboratories handling pathogens within the Mycobacterium tuberculosis complex (MTBC). The MTBC Biosafety Directive provides a stratified approach to the containment of MTBC according to the specimen type and procedures used. More specifically, this directive specifies activities that can be safely performed at a lower containment level (i.e., Containment Level 2 with additional biosafety requirements) than what is normally required for research and higher risk activities with pathogens categorized at Risk Group 3.

  The Biosafety Directive for MTBC was developed with input from several external MTBC experts, including the Canadian Tuberculosis Laboratory Technical Network (CTLTN) and the Canadian Biosafety Officer Network (BSON) of the Canadian Public Health Laboratory Network (CPHLN). The MTBC Biosafety Directive is now available to stakeholders and other interested parties.

• Biosafety Directive for Human Immunodeficiency Virus (HIV) and Human T-cell Lymphotropic Virus Type 1(HTLV-1) (January 21, 2014)

  The Public Health Agency of Canada, in collaboration with an Ad hoc Expert Group for HIV and HTLV, has developed a Biosafety Directive for HIV and HTLV-1 which provides a comprehensive overview of the updated containment level requirements for laboratories working with HIV and HTLV-1. The Biosafety Directive for HIV and HTLV-1 is now available to stakeholders and other interested parties.

2) Biosafety advisories are developed when the data obtained from a Risk Assessment of a new or emerging pathogen of interest indicates that new physical and/or operational requirements are required to work with the pathogen safely. The new operational and/or physical requirements need to be disseminated to interested parties as soon as possible for the safe handling of the material. In order to ensure accuracy, biosafety advisories are reviewed frequently and updated when more information becomes available.

• Zika Virus (April 14, 2016)
• Influenza A(H7N9) Virus: Joint Biosafety Advisory (Updated March 17, 2014)
• Middle East Respiratory Syndrome Coronavirus (MERS-CoV) (Updated July 7, 2015)
• Efficiently Transmissible Engineered Influenza A H5N1 Viruses: Biosafety Advisory (February 1, 2012)
• Novel H1N1 Flu Virus (Human Swine Flu) Advisory (June 15, 2009)
• Highly Pathogenic Avian Influenza: Advisory (March 10, 2004)
• Severe Acute Respiratory Syndrome: Advisory (March 25, 2003)
• West Nile Virus (June 2001, Revised June 2003)
  • Surveillance of West Nile virus
  • For further information on where to submit specimens for testing, please contact the office located in your province/territory by accessing the link to the Canadian Cooperative Wildlife Health Centre

3) Biosafety notifications are developed when the data obtained from a Risk Assessment for a particular pathogen indicates that no changes will be required to the pre-existing physical and operational requirements. The notification is created to emphasize these requirements to limit the spread of the particular pathogen.

• Experimental Studies that May Increase the Risk of a Pathogen: Special Biosafety Notification (January 23, 2012)
• New Delhi metallo-beta-Lactamase-1 (NDM-1) containing bacteria: Special Biosafety Notification (August 20, 2009)