Biosafety Permit

Requirement for University of Toronto Biosafety Permit

A University of Toronto Biosafety Permit is required for any research or teaching activities which involve the use or manipulation of biological materials and which are conducted on University premises, or in a building or location administered by, or under the control of, the University.

All activities involving biological materials, whether directly supported by grants or contracts administered by the University or not, must be identified on the application for a University of Toronto Biosafety Permit. The release of related grant funds by the University is dependent on an approved University Biosafety Permit.

The submission of an application for a University of Toronto Biosafety Permit implies willingness to allow the U of T Biosafety Officer or Health and Safety Officers to visit or inspect the laboratory sites used by the Biosafety Permit holder in order to determine compliance with the Human Pathogens and Toxins Act and Regulation, the Canadian Biosafety Standards, the Canadian Biosafety Handbook, and these policies and procedures.

Applying for a permit to work with biological materials

In order to work with biological materials at the University of Toronto, Principal Investigators must have a Biosafety Permit approved by the University.

Application forms (PDF) for a University Biosafety Permit along with Explanatory Notes to assist the applicant are available on the EHS website.

The completed form may then be signed by the applicant and the department chair and submitted to the Local Biosafety Coordinator for review and approval.

The required information must be typed on the application form. The Principal Investigator should use a single form to identify projects and locations for both risk groups 1 and 2, but a separate form must be completed for risk group 3 agents. The hazardous biological materials to be used (e.g. human whole blood, Hepatitis B virus, chick embryo primary cell culture, CHO cells, E. coli O157) must be disclosed and usage and storage information must be provided, e.g. building(s) and room number(s).

After entering the requested information, Biosafety Permit application forms should be signed by the Principal Investigator and by the departmental Chair, and then submitted directly to the Local Biosafety Coordinator with jurisdiction over the laboratory location. The Local Biosafety Coordinator will review the application form and forward it to the Biosafety Office for additional review (e.g. medical surveillance requirements) and approval by the Senior Biosafety Officer and IBC Chair.

Following the review and approval process, a copy of the approved Biosafety Permit will be returned to the applicant. The original will be retained on file in EHS. Information will also be entered into RIS (Research Information System) for review by the Research Services Office, and shared with Campus Police for emergency response. A valid Biosafety Permit must be on file before the University will release grant funds.

Containment Level 1:

The University Biosafety Permit for activities requiring Containment Level 1 is valid for three years from the date of approval. The Principal Investigator / Course Instructor must submit a new application form even if the activities involving biological materials have not been altered or modified since the previous submission.

Containment Level 2:

The University Biosafety Permit for activities requiring Containment Level 2 conditions is valid for two years from the date of approval. In the case of multi-year research or recurring teaching programs involving risk group 2 biological materials, the Principal Investigator / Course Instructor must submit a new application form, even if the activities involving biological materials have not been altered or modified since the previous submission.

Containment Level 3:

University Biosafety Permits for Containment Level 3 conditions are valid for one year from the date of final approval. In the case of multi-year research projects involving risk group 3 materials, the Principal Investigator must submit a new application form, even if the activities involving the biological materials have not been altered or modified since the previous submission.

Amendment form to add biological material(s) to a Biosafety Permit (PDF)

It is only permissible to perform activities and use the biological material(s) listed on the Biosafety Permit and amendment(s) in the specified location(s) and by the listed personnel approved in a Biosafety Permit application and amendment(s). The use of additional biological materials, new locations, new personnel and any other significant changes must be requested via submission of a Biosafety Permit amendment form. Any proposed changes to the work must not be implemented until the amendment is approved.

Memorandum of Understanding and Agreement on Biosafety (PDF)

All lab personnel must read and understand the statements listed in the MOU and sign off on the MOU in order to be authorized to work with biological materials in the laboratory. The MOU must be kept on file in the laboratory and for three years after the last day of work of the personnel.