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Changes to the Biosafety Program

New Biosafety Program Permit reduces wait times and administrative work for the release of grants funds.

November 20, 2018 — 

To reduce the administrative work for the release of grant and contract funds, the old Biosafety Project Approval Certificates (BPAC) will now be combined with Biosafety Permits in a simplified system.

Biosafety Program Permits replaces the old system January 1, 2019, and will encompass both processes. The new, simplified system will reduce wait times and eliminate re-applications common in the old system.   

What is a biosafety program permit?

A biosafety program permit documents facilities, personnel, equipment and scope of research of the Principal Investigator (PI). The scope of research is reviewed by the institutional biological safety advisory (BSAC) committee as part of our Plan for Administrative Oversight required for our Human Pathogens and Toxins Act License with the Public Health Agency of Canada. It is required for the release of grant and contract funds for university researchers whose project involves work with Risk Group 1-3 biological agents.

A biosafety program permit can be applied for through a questionnaire in the Environmental Health and Safety Assistant (EHSA) Database

What information does a biosafety program permit include?

The questionnaire requests information about the following:

  • Principal Investigator (permit-holder) and alternate contact information
  • Personnel, facilities and equipment
  • Site specific training, operating and waste procedures in use
  • Description of the scope of research, including objectives, plan and potential hazards
  • Adding and amending grants/contracts (for new funds only, not retroactive)

Facility Certification

Based on this information, the biosafety program permit will be assigned a level depending on the risk group and containment requirements for the biological agents used. 

Biosafety Permit Tiers

Tiers of Biosafety Permits at the University of Manitoba are as follows:

  • Containment Level (CL)1/Clinical
    • Work with RG1 biological agents
    • Providing clinical services
    • Collecting clinical samples from patients or participants
  • CL2 (Unregulated)
    • Work with samples which are not known to be pathogenic
    • May be contaminated with pathogens
    • Blood, body fluid, tissues, cell cultures etc.
  • CL-2R (Regulated)
    • Controlled activities
    • Human and Terrestrial animal pathogens and toxins
    • Risk group and containment level 2
  • CL-2R + RG3
    • Controlled activities
    • Narrow range of Risk group 3 containment level 2 pathogens

Facilities will be certified at the appropriate containment level for the declared scope of work using the Canadian Biosafety Standard. The certification will need to be posted in all your spaces, similar to the previous biosafety permit.

What’s different with the biosafety program permit?

The previous biosafety permit and BPAC processes are now integrated into one. Whether you are adding new personnel to your lab or need to release new research funds, the program permit is designed to include all changes to your bio-agent use lab.

BPACs are no longer required to release grant/contract funds for each project. The biosafety program permit covers a researcher’s entire scope of work, and any new funds can be released without committee review if the scope of the project falls within the approved research program. Projects with new biological agents or procedures may need to be reviewed by the BSAC committee as an amendment to your program’s research scope. More information regarding submission deadlines and the approval process can be found on our webpage.

Note: There are no changes to the process for external applicants for release of funds.

When and how can I start my biosafety program permit?

Existing biosafety permit holders can find the questionnaire in EHSA, along with a guiding document on how to fill out the biosafety program permit questionnaire. You can begin your questionnaire at any time, but to release funds as of January 2019 only biosafety program permit submissions will be accepted. 

If you are new to the University of Manitoba, or have questions about our new program permits, please contact us at biosafety [dot] program [at] umanitoba [dot] ca  

 

 

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