Biological Safety Permits

To apply for a biosafety certificate, follow the below steps or refer to ERSO How-to Videos at the bottom of page.

1. Ensure that all workers working with biological materials have the appropriate training.

2. Complete the Application for Biological Safety Certificate through the ERSO Portal. 

   • Refer to the ERSO Guide for Researchers for guidance about completing your application through ERSO or watch the How-to Video included at the bottom of this page.

   • If you have any biosafety related questions for your application, please consult with the Biosafety Officer by contacting ccc@uwindsor.ca.

   • If you experience any technical issues with ERSO, please contact the Office of Research and Innovation Services (ORIS) at erso@uwindsor.ca. 

3. When your application has been submitted through ERSO, it will move to the "Applications: Under Review" folder. Once it has moved to this folder, you may view your submission, but edits cannot be made to the application. The Biosafety Officer will conduct an initial file audit of the application to identify any potential issues. Once satisfied, the Biosafety Officer will forward the application to the Research Safety Committee for vetting.

4. The Research Safety Committee will review the application and may approve, conditionally approve, or defer the application.

   • If you receive a deferral decision, address outstanding conditions, and consult with the committee and the Biosafety Officer.

   • If you receive a conditional approval, address the minor changes, and resubmit application to the committee for final approval.

   • Once approved, you will receive an email notifying you of the decision, with a copy sent to the Biosafety Officer and Environmental Health and Safety Manager. You can view your approved application in ERSO under the "Applications: Post Review" folder. 

5. A copy of the biosafety permit will be sent to the Principal Investigator to print and display in their facility and the University of Windsor Certification Management System (ERSO) will be updated to reflect the new permit.

NOTE: Principal investigators must adhere to the conditions specified in their application, and the Research Safety Committee may visit a laboratory to confirm that approved protocols are being followed. Ensure that you have a Biological Inventory List Sheet available, as this will be checked during regular biosafety inspections.

Any changes to materials, personnel, and facilities require an amendment to the biosafety permit. To submit a biosafety amendment, follow the below steps or refer to ERSO How-to Videos at the bottom of page.

1. Complete the Renewal/Amendment to Biological Safety Certification through the ERSO Portal. 

   • Click on the “Applications: Post Review” folder. 

   • Click the “Events” button on the application you wish to amend.

   • Under the “Create New Event” heading, select the "Renewal/Amendment to Biological Safety Certification" form. 

   • Fill in the required information and outline the changes being made to your permit.

   • Click the “Submit” button.  Indicate any further comments, if required, in the pop-up comment box, and then click submit. 

   • Refer to the How-to Video at the bottom of this page for further guidance. 

2. When your amendment has been submitted through ERSO, you can view it under the “Applications: Post Review” folder. Click the “Events” button on the application in which you submitted the amendment. You will see your submitted amendment under the “Events: Under Review” folder. The Biosafety Officer will conduct an initial file audit of the amendment to identify any potential issues. Once satisfied, the Biosafety Officer will forward the amendment to the Research Safety Committee for vetting.

   • If there are reviewer comments, you will see them under the header "Events: Requiring Attention" on the ERSO homepage, and it will be highlighted in red.

   • Click on "Events: Requiring Attention", and then click "Events" under the corresponding file. 

   • Select the "Latest Workflow" button under the "Events Requiring Attention" folder. You will then be able to view the comments under the "Logs" tab. 

   • Make the requested edits in the application and click "Re-Submit." Indicate any further comments, if required, in the pop-up comment box, and then click submit.  

3. The Research Safety Committee will review the application and may approve, conditionally approve, or defer the application. 

   • If you receive a deferral decision, address outstanding conditions, and consult with the committee and the Biosafety Officer.

   • If you receive a conditional approval, address the minor changes, and resubmit application to the committee for final approval.

   • Once approved, you will receive an email notifying you of the decision, with a copy sent to the Biosafety Officer and Environmental Health and Safety Manager. You can view your approved amendment in ERSO under the “Applications: Post Review” folder. Click the “Events” button on the application in which you submitted the amendment. You will then see your approved amendment under the “Events: Post Review” folder.

4. A copy of the amended biosafety permit will be sent to the Principal Investigator to print and display in their facility and the University of Windsor Certification Management System (ERSO) will be updated to reflect the new permit.

If you have any biosafety related questions for your application, please consult with the Biosafety Officer by contacting ccc@uwindsor.ca.

If you experience any technical issues with ERSO, please contact the Office of Research and Innovation Services (ORIS) at erso@uwindsor.ca. 

Biosafety certificates are valid for one to three years, depending on the risk classification of the project (see pages 7-10 of the Biosafety Manual for more information). If a certificate is set to expire, a renewal application is required and should be submitted to the Research Safety Committee at least two months before the expiration date for review and approval. Follow the steps below or refer to ERSO How-to Videos at the bottom of page.

1. Complete the Renewal/Amendment to Biological Safety Certification through the ERSO Portal. 

   • Click on the “Applications: Post Review” folder. 

   • Click the “Events” button on the application you wish to renew.

   • Under the “Create New Event” heading, select the "Renewal/Amendment to Biological Safety Certification" form. 

   • Fill in the required information and outline any changes being made to your permit. If there are no changes to your biosafety permit, you may click the "Renewal Only: No Changes" box in the amendment/renewal form and complete the remainder of the application as required. Please note that if there has been a change in the authorized personnel, this constitutes as a change to the permit. 

   • Click the “Submit” button. Indicate any further comments, if required, in the pop-up comment box, and then click submit. 

   • Refer to the How-to Video at the bottom of this page for further guidance. 

2. When your renewal has been submitted through ERSO, you can view it under the “Applications: Post Review” folder. Click the “Events” button on the application in which you submitted the renewal. You will see your submitted renewal under the “Events: Under Review” folder. The Biosafety Officer will conduct an initial file audit of the renewal to identify any potential issues. Once satisfied, the Biosafety Officer will forward the renewal to the Research Safety Committee for vetting.

   • If there are reviewer comments, you will see them under the header "Events: Requiring Attention" on the ERSO homepage, and it will be highlighted in red.

   • Click on "Events: Requiring Attention", and then click "Events" under the corresponding file. 

   • Select the "Latest Workflow" button under the "Events Requiring Attention" folder. You will then be able to view the comments under the "Logs" tab.

   • Make the requested edits in the application, and click "Re-Submit." Indicate any further comments, if required, in the pop-up comment box, and then click submit. 

3. The Research Safety Committee will review the application and may approve, conditionally approve, or defer the application. 

   • If you receive a deferral decision, address outstanding conditions, and consult with the committee and the Biosafety Officer.

   • If you receive a conditional approval, address the minor changes, and resubmit application to the committee for final approval.

   • Once approved, you will receive an email notifying you of the decision, with a copy sent to the Biosafety Officer and Environmental Health and Safety Manager. You can view the approved renewal in ERSO under the “Applications: Post Review” folder. Click the “Events” button on the application in which you submitted the renewal, and you will see your approved renewal under the “Events: Post Review” folder.  

4. A copy of the renewed biosafety permit will be sent to the Principal Investigator to print and display in their facility and the University of Windsor Certification Management System (ERSO) will be updated to reflect the new permit.

If you have any biosafety related questions for your application, please consult with the Biosafety Officer by contacting ccc@uwindsor.ca.

If you experience any technical issues with ERSO, please contact the Office of Research and Innovation Services (ORIS) at erso@uwindsor.ca. 

1.0     PURPOSE

This standard operating procedure (SOP) describes the Research Safety Committee’s (RSC) process for expired biosafety certificates.

2.0     SCOPE

This SOP applies to biosafety permits that are approaching and/or have expired. The SOP outlines the steps that will be taken to notify the Primary Investigator of the impending expiration and the notifications and actions that will be taken should a renewal application not be completed.

3.0     RESPONSIBILITIES

The Research Safety Committee (RSC) is responsible for establishing and enforcing the University’s Research Safety Programs. The RSC formulates and reviews such programs as are necessary to ensure that the University is in compliance with guidelines and regulations outlined by the Canadian Nuclear Safety Commission (CNSC), Public Health Agency of Canada, Canadian Food Inspection Agency (CFIA), The Ministry of Environment, and all applicable Federal, Provincial and municipal legislation. The RSC reviews, approves and enforces the standards through the issuance of Certificates for all work with potentially hazardous biological, radioactive, and chemical materials, the oversight of research programs involving laser safety, biohazard safety and radiation safety. If the RSC finds that a principal investigator is not following their approved protocol, the RSC reserves the right to suspend/revoke a previously approved certificate, which would suspend all research activities and access to research funds until further notice.  

The Biosafety Officer (BSO) provides advice and assistance in matters related to biological safety, performs laboratory inspections and assists in the administration of the biosafety program. Responsible for tracking and notifying the Primary Investigator of impending expired permits.

The Primary Investigator (PI) is responsible for obtaining and renewing biological safety permits when required and ensuring that all conditions of the certificate and the Biological Safety Manual are followed. The PI is responsible for ensuring that all the information included in their permit application is accurate and should the PI wish to cancel their permit, they are responsible for notifying the RSC.

The Department Head is responsible for ensuring that the PIs within the department are adhered to the conditions of biological safety certificates and that the Biological Safety Manual is followed.

The Dean is responsible for ensuring that the PIs within the faculty are adhering to the conditions of biological safety certificates and that the Biological Safety Manual is followed.

The Office of Research & Innovation Services (ORIS) administers research grants and contracts and is the point of contact for the federal granting councils, government ministries, industry, associations and foundations which typically provide financial support for the university scholarship research and creative activities.

4.0    DEFINITIONS

eRSO Research Portal – The University of Windsor’s hosted system, Electronic Research Services Office (eRSO), is a database for the digital management and reporting of internal and external research funding and certifications. The portal offers faculty and researchers online access to the database to create, collaborate, manage, submit, edit, review and make determinations on applications, supported by the electronic workflow, including approvals by department and faculty. The RSC utilizes eRSO for reviewing research applications (new applications, amendments, renewals) and maintains all records associated with research applications within eRSO.

5.0    PROCEDURE

5.1    The University of Windsor’s Biological Safety Manual establishes the policies of the Biological Safety sub-committee of the RSC. The manual includes information about safe usage and handling of biological materials and the required laboratory safety procedures. Section 1.4.4 Biological Safety Certificate Renewal and Validation Periods outlines the timeline for certification renewals:

Containment Level 3 (1 year only)

A Biological Safety Certificate for activities requiring Containment Level 3 conditions is valid for one year from the date of approval by the University of Windsor’s Research Safety Committee. The Principal Investigator / Course Instructor must submit a new application form, even if the activities involving biological agents have not been altered or modified since the previous submission.

Containment Level 2 (2 year only)

A Biological Safety Certificate for activities requiring Containment Level 2 conditions is valid for two years from the date of approval by the University of Windsor’s Research Safety Committee. In the case of multi-year research or recurring teaching programs involving potentially hazardous biological agents, the Biological Safety Certificate must be renewed annually. The renewal is valid for one year from the expiration date of the previous Certificate. The Principal Investigator / Course Instructor must submit a new application form, even if the activities involving biological agents have not been altered or modified since the previous submission.

Containment Level 1 (3 years)

A Biological Safety Certificate for activities requiring Containment Level 1 is valid for three years from the date of approval by the University of Windsor’s Research Safety Committee or, in the case of renewal, from the expiration date of the previous Certificate, after which it must be renewed. The Principal Investigator / Course Instructor must submit a new application form even if the activities involving biological agents have not been altered or modified since the previous submission.

5.2    When a biosafety certificate is due for renewal, the following steps shall be taken:

Initial Notification – Two weeks prior to expiry date

The Biosafety Officer will forward an email with the subject line “Biosafety Permit Renewal is Due” to the Primary Investigator (PI) and a copy to the RSC informing them that the permit is due to be updated and includes instructions on how to renew the permit in the eRSO Research Portal.

Second notification – One week prior to expiry date

The Biosafety Officer will forward an email with the subject line “Biosafety Permit Renewal is Due – Second Notification” to the PI and a copy to the RSC informing them that the permit is due to be updated and includes instructions on how to renew the permit in the eRSO Research Portal.

Third notification – On the date of expiration

The Biosafety Officer will forward an email with the subject line “Biosafety Permit Now Expired” with a copy to the Department Head and the RSC. The email will inform the PI of two options, 1 – Apply for a permit renewal or 2 – Contact the RSC that they wish to close the permit.

Fourth notification – Two weeks past due

The RSC will forward an email with the subject line “Biosafety Permit Now Cancelled” with a copy to the Department Head and the Dean. The email will inform the PI that all work associated with the project is to cease immediately and that the Biosafety Officer has been directed to ensure that the room(s) and any biological materials associated with the project be safeguarded and that ORIS will be notified of the expired permit.

Notification to ORIS

The RSC will forward an email with the subject line “Expired Safety Certificate – Project [#####]” with a copy to the Biosafety Officer and Director, Campus Safety and Emergency Planning. The email will inform ORIS of the expired permit, indicating the notifications sent to the PI.