Policy 58: Use of Biohazardous and Infectious Materials in Research and Teaching

1. Purpose

While the use of Biohazardous or Infectious Materials can be very valuable to determine new knowledge and understanding, they may present a potential risk to the well-being of humans or other animals, either directly through infection or indirectly through disruption of the environment. The purpose of this Policy is to ensure that the use of Biohazardous or Infectious Materials in the course of Scholarly, Research and Creative (SRC) and/or teaching activities undertaken by the Toronto Metropolitan University (TMU) community is done so in a responsible manner that ensures the safety of students, faculty, staff, the community and the environment. This Policy also assures the use of such material conforms with the terms of the University's Pathogen and Toxin Licence obligations issued by the Public Health Agency of Canada.

2. Application and Scope

This Policy applies to all members of the TMU community (faculty, staff including postdoctoral fellows, and graduate and undergraduate students) using Biohazardous or Infectious Materials in the course of SRC and/or any teaching activities under the auspices of the University.

3. Definitions

3.1 “Biohazardous Materials” means any biological material, which is potentially harmful to humans, animals, plants and/or the environment.

3.2. "Biosafety" means the containment principles, technologies, and practices that are implemented to prevent unintentional exposure to Biohazardous or Infectious Materials, and their accidental release.

3.3. "Biosecurity" means the security measures designed to prevent the loss, theft, misuse, diversion, or intentional release of regulated Infectious Materials under the University's Pathogen and Toxin Licence, and other related assets (e.g., personnel, equipment, non-Infectious Material, animals, sensitive information).

3.4. “Infectious Materials” means any isolate of a pathogen or any biological material that contains human or animal pathogens and, therefore, poses a risk to human or animal health as defined by the Government of Canada's Canadian Biosafety Standards.

3.5. “SRC Activity” means funded and non-funded creative, scholarly, and/or knowledge-generating activities, whether fundamental or applied, whose primary objective is discovery, problem-solving, or to achieve some desired result that can be specified to a significant extent but that cannot be produced with existing knowledge. SRC Activity is undertaken in the course of an individual’s role at the University, and is made, discovered or developed using the University facilities, support personnel, support services, equipment, materials or funds, or otherwise under the auspices of the University.

4. Policy

No SRC and/or teaching activities using Biohazardous or Infectious Materials shall be conducted by any member of the University unless the activity has been approved through the issuance of a biosafety permit from the University's Biosafety Officer, and any necessary ethics approvals in accordance with University policies, as relevant.

5. Procedure

All individuals working with Biohazardous or Infectious Materials shall do so in accordance with the applicable regulations and standards and established processes and procedures outlined in the University's biosafety program.

6. Roles and Responsibilities

6.1. Licence Holder

6.1.1. The licence holder has the ultimate executive power over the University’s pathogen and toxin licence and is responsible for supporting the University through the provision of adequate resources, both human and financial, to ensure competent administration of the biosafety program and that all controlled activities under the licence are maintained in accordance with all relevant legislation.

6.2. Institutional Biosafety Committee

6.2.1. The institutional biosafety committee is vested with the ultimate authority to determine Biosafety and Biosecurity policies and procedures within the University and to oversee and enforce the University’s biosafety program to ensure compliance with required legislation, standards and guidelines.

6.3. Biosafety Officer

6.3.1. The University's Biosafety Officer (BSO) is responsible for managing the administrative operations of the biosafety program and oversees the Biosafety and Biosecurity practices at the University. The BSO has the authority to immediately order the stoppage of any use of Biohazardous or Infectious Materials which deviates from the approved biosafety permit or is deemed to be in non-compliance with relevant legislation, regulations or University policies and procedures.

6.4. Biosafety Permit Holders/Principal Investigators

6.4.1. Biosafety permit holders have overall accountability for ensuring all activities with Biohazardous or Infectious Materials under their supervision are in compliance with the protocols and procedures outlined in the University’s biosafety program and any additional requirements prescribed by their biosafety permit or a regulatory authority.

6.5. Authorized users

6.5.1. Authorized users are responsible for working in compliance with all related Biosafety and Biosecurity policies, procedures and requirements as set out in the University’s biosafety program.

7. Related Documents

Biosafety Website - includes the biosafety program manual and permit application process
Policy 51: Ethical Conduct for Research Involving Human Participants
Policy 52: Ethics Review of Research involving Animals
Human Pathogens and Toxins Act and Regulations
Health of Animals Act and Regulations