Overview

What is a biosafety permit?

A biosafety permit documents a researcher's facilities, personnel, materials and scope of research.

An approved biosafety permit ensures compliance with all regulatory agencies and allows for the release of research funds from the Office of Research Services.

When is a biosafety permit needed?

Work with live biological agents must be described in a UM biosafety permit while they are being used, stored or manipulated in a UM facility.

Work with all biological agents is reviewed to verify that potential biohazards have not been underestimated.

A permit is no longer needed when the agent is sterilized (autoclaved), chemically fixed or undergoes another process that renders the sample non-viable (cell lysis).

Where on campus is a biosafety permit required?

The biosafety permit applies to labs owned by the University of Manitoba and labs where the UM is contracted to provide safety services.

These include:

  • Both Fort Garry and Bannatyne campuses
  • Research Institute of Oncology and Hematology
  • Children’s Hospital Research Institute of Medicine
  • Health Sciences Centre Research Foundation
  • Kleysen Institute of Advanced Medicine (HSC)

Researchers in external facilities (e.g. St. Boniface Research Centre, National Microbiology lab etc.) are required to follow the university’s health and safety policies and procedures.

Who can hold a biosafety permit?

Faculty who work with and store live biological agents on UM property can hold a biosafety permit. Support staff and students who will be working with live biological agents must be listed on the permit.

Types of biosafety permits

A permit classification will be assigned to permits depending on the biological materials and procedures being used. Facilities will need to meet specific design, safety and security requirements for their designated permit type as outlined in the Canadian Biosafety Standard and Handbook.

Clinical biosafety permits This permit covers areas where clinical services are being provided such as collecting clinical samples from patients or participants or storing these collected samples. Any further handling or analyses of these samples require a CL 2 permit.
Containment Level 1 CL 1 permits are for work with Risk Group 1 biological materials.
Containment Level 2 (Unregulated) CL 2 permits are for work with samples which are not known to be pathogenic but may be contaminated with pathogens (such as cell lines, blood and body fluids etc).
Containment Level 2R (Regulated) This permit is for controlled activities that involve direct work with pathogens (Risk Group 2 and higher). In addition to CL 2 facility requirements, security requirements must also be met.
Containment Level 2R and Risk Group 3 (Regulated) This permit is for controlled activities for a narrow range of Risk Group 3 biological materials that can be handled at containment level 2.
Containment Level 3 and 4 Not available at the UM

Storage Permits

Storage permits allow for the storage of biological materials without holding a full biosafety permit. This permit does not allow active work with these materials and cannot be used for the release of grant funds.

If you would like to step down your permit to storage only, please review the Biosafety Policy and Procedure Statement: Biological Agent Storage Permits 2019 (PDF).

Biosafety permit process and approvals

Applications

Initial biosafety permit applications are reviewed and approved by the Biosafety Committee at monthly meetings. Once approved, this permit can be amended to update information as needed.

Amendments are also required for the release of research funds from the Office of Research Services.

Amendments

Once a program permit has been approved, it can be amended to update information (such as personnel, facilities, research and new project additions). Depending on the type of amendment, it can be approved by the biosafety officers or Biosafety Committee chair on a weekly basis.

If the submitted amendment increases the risk of the approved permit, this amendment will need to be reviewed and approved by the committee at monthly meetings.

Terminating a permit

To terminate a biosafety permit, complete a Declaration of Decommissioning Form (DOC) and submit it to biosafety.program@umanitoba.ca.

Committee meeting schedules

The Biosafety Committee meets on the third Thursday of each month to review submissions. There is no meeting scheduled for the months of July and December. 

Submissions for committee review are due the first Thursday of each month at 4:30pm Central Time.

Instructions for biosafety permit submissions

Initial applications/First time users

  1. Request access to the Environmental Health and Safety Assistant database

    ** The server can be slow and time out, for sections that require extensive writing, please write your answers in a word document and copy them into the questionnaire**.

  2. Login to EHSA using your UMNetID credentials.
  3. Under the Questionnaire menu, click Biosafety Permit to access the new questionnaire. Allow the sections for the questionnaire to load (the page should refresh and sections will appear).
  4. There are 19 sections to complete. You can save your submission at any time by clicking the Save & Stay button at the bottom of each section. You can navigate to any section by clicking on the section name on the left-hand side menu. Use our Biosafety Permit Guide (PDF) to assist you in filling out this questionnaire.
    1. To exit the questionnaire, click My Biosafety Permit…. in the menu at the top of the screen
    2. Your submission will be saved as a draft and is located in your dashboard. To edit an existing draft, click Edit.
  5. When you have completed the questionnaire, review the Assurances section and click on the checkbox (in this section a PDF version of your application can be downloaded for your records) and click Submit.

Review and respond to reviewer comments

  1. Login to EHSA using your UMNetID credentials.
  2. Under the Questionnaire menu, click Biosafety Permit to access the dashboard.
  3. Click the Edit button next to the submission that is "In Review".
  4. Ensure that “show all questions” is selected from the drop-down menu that’s along the top of the screen.
  5. The sections with comments have numbered bubbles next to them on the left hand menu. Scroll through the section to see the comments made by reviewers and click Reply to this entry to respond to the comments.
  6. When comments have been addressed, click Submit for Review at the top of screen.

Submit an amendment

  1. Login to EHSA using your UMNetID credentials.
  2. Under the Questionnaire menu, click Biosafety Permit o access the dashboard.
  3. On the menu along the top, click Add/Amend/Renew Biosafety Permit and click Amend or Change an existing.
  4. This will open your currently approved biosafety program permit and will allow you to make changes to the permit.
  5. When desired changes have been made, click Submit for Review at the top of screen.

If you are amending your permit for the release of research funds, ensure you have appropriately answered the questions in the "Adding Grants and Contracts" section. Described EXACTLY how the project fits within your proposed scope of research program. Simply putting "it fits within my program" or "procedures are as described" will delay approval.

Terminate a permit

  1. Complete a Declaration of Decommissioning Form (DOC) and submit to biosafety.program@umanitoba.ca.
  2. Login to EHSA using your UMNetID credentials.
  3. Under the Questionnaire menu, click Biosafety Permit to access the dashboard.
  4. On the menu along the top, click Add/Amend/Renew Biosafety Permit... and click Amend or Change an Existing Permit. This will open your currently approved biosafety program permit and will allow you to make changes to the permit.
  5. Under the Permit Process Questions section, select "Termination" from the drop-down for the "What's the purpose of this application?" question.
  6. Click Save and Stay at the bottom of the screen, this will remove the remaining question sections.
  7. Click Submit for Review at the top of screen.