The University of Toronto Biosafety Program is designed to protect lab personnel and the public from potential exposure to biological materials used within the University and to prevent unintentional release into the environment. The program includes a number of components, including laboratory containment requirements (physical and operational controls); medical surveillance (including immunization where appropriate); classroom and online training; and compliance with regulatory requirements for importing and shipping biological material.
The Biosafety Team under the Office of Environmental Health & Safety administers this program by providing expertise and technical support. The Biosafety Team, in conjunction with the EHS office and the Local Biosafety Committees, execute the mandate of the Institutional Biosafety Committee (IBC), which is charged with ensuring that all activities within the University involving biological agents are conducted in a safe manner and in conformity with generally accepted standards.
Biological agents used at the University include: viruses; bacteria; fungi; prions; toxins; viral vectors; recombinant DNA (rDNA); synthetic DNA (sDNA); microorganisms; parasites, human / animal tissues; cell lines and cell cultures; and blood and bodily fluids from humans and animals.
Biological agents are classified into Risk Groups based on their inherent characteristics (e.g. pathogenicity, mode of transmission, etc.) and risk to the health of individuals and the surrounding community. Risk groups range from the least hazardous RG1 agents (e.g. non-pathogenic E. coli K-12) up to the most hazardous RG4 agents (e.g. Ebola and monkeypox viruses). Work with RG4 agents is not permitted at the University of Toronto. The following sites may be used to help you identify the risk group of the biological agent you are working with:
- Pathogen Safety Data Sheets (PSDS) from the Public Health Agency of Canada (PHAC)
- ePATHogen - Risk Group Database from PHAC
- Schedules 1-5 of the Human Pathogens and Toxins Act
- Risk Group Database from the American Biological Safety Association
When the risk group is factored into the overall risk assessment, which includes other environmental factors (e.g. quantity of the agent, aerosol production, usage of sharps, etc.), the appropriate Containment Level (CL) of the laboratory space can be determined. At U of T, most laboratories where biological agents are used fall under the CL1 or CL2 category. The operational and design requirements for a CL3 facility are much more stringent than a CL1 or CL2 space.
In Canada, facilities where Risk Group 2, 3, and 4 human pathogens or toxins are handled and stored are regulated by the Public Health Agency of Canada (PHAC) under the Human Pathogens and Toxins Act (HPTA) and the Human Pathogens and Toxins Regulations (HPTR). The importation of animal pathogens, infected animals, animal products or by-products (e.g., tissue, serum), or other substances that may carry an animal pathogen or toxin or parts thereof are regulated by the PHAC or the Canadian Food Inspection Agency (CFIA) under the Health of Animals Act (HAA) and Health of Animals Regulations (HAR). Zoonotic pathogens, capable of causing disease in human and animal hosts that are imported into Canada are regulated by HPTA, HPTR, HAA and HAR.
The University has developed biosafety policies and procedures with the objective of meeting the minimum requirements set out in the applicable standards:
- Canadian Biosafety Standard (CBS)
- Canadian Biosafety Handbook (CBH)
- Canadian Biosafety Guideline - Containment Level 1: Physical Design and Operational Practices
- Containment Standards for Facilities Handling Plant Pests
- Containment Standards for Facilities Handling Aquatic Pathogens
Under the conditions of the University's license from PHAC, the Biosafety Officer (BSO) must notify PHAC if any of the following situations occur:
- Where a human pathogen or toxin has been inadvertently released from a facility.
- If a permit holder has in their possession or inadvertently produces a human pathogen or toxin that is not listed on their permit.
- When an incident involving a human pathogen or toxin has caused or may have caused disease in an individual.
- When there is reason to believe that a human pathogen or toxin has been stolen or is missing.
Should you become aware of any of the above circumstances at UTSC, CONTACT THE BSO IMMEDIATELY!
A biosafety permit is required prior to purchasing, importing or conducting projects involving biological agents. Biosafety permit applications must be filled out and signed by the PI and Departmental Chair before the Local Biosafety Committee reviews it. The permit application form fulfills several documentation requirements, including (but not limited to): local risk assessments for the proposed work and mitigation strategies; list of authorized users approved to handle the materials listed; biosafety training records; and basic inventory of where the approved materials are used / stored.
Any proposed changes to your permit should be submitted for approval prior to implementing the changes, which includes providing the Biosafety Office with updates on the following:
- User list of authorized personnel attached to the permit: this should be done at any time personnel join and leave the laboratory
- Biological agents being used or stored: any additions require an Amendment Form to be submitted
- Rooms / locations where work with biological agents is undertaken
- Decommissioning or changes affecting the required containment level of a work location
Biological Safety Cabinets (BSCs)
BSC certification by a third party vendor is required:
- Annually, regardless of what the cabinet is used for
- When installed
- After being moved
- After major services or repairs
All personnel working in a BSC should be familiar with and follow the applicable SOPs so as to avoid exposure to, or release of pathogens. Working knowledge of the best practices and proper use of this essential piece of safety equipment should be considered important and reviewed periodically. For a full overview of how to work in a BSC, refer to Section 11.4.2 in the CBH.
For information about certification vendors for your BSC, please contact the EHS office.
EHS provides in-class and online training courses on biosafety, bloodborne pathogens, and other biosafety-related topics.
In addition, a hard copy of the Memorandum of Understanding and Agreement on Biosafety (MOU) signed by each lab worker on the biosafety permit must be kept on file for at least 3 years from the last date of their appointment.