Biosafety Internal Permit Permit Request

Scope of Application

a) All Principal Investigator/Faculty members use/planning to use risk group* 2 or above (as defined by the PHAC) biological materials and/or human blood, body fluids, cell lines, sewage water and/or toxins at locations administered by the University of Winnipeg are required to apply for and obtain an approved Internal Biosafety Permit. No research funds will be released for the acquisition of Biological Materials until an approved Internal Biosafety Permit and Approval Certificate are submitted to the Research Office by the BSO.

b) All lab personnel and Permit holders must be registered with the Safety Office.

c) Biosafety permits are not required in areas that only receive biological materials in a fixed state.

If you have answered NO to all of the questions in the Instructions section, you do not need a Biosafety Permit.

CONDITIONS OF APPROVAL:

To qualify for a Biosafety permit the permit holder is responsible for establishing and maintaining the following conditions:

1. Work in areas controlled and/or used by the permit holder shall be in conformity with all applicable federal, provincial, municipal and institutional acts, regulations and guidelines at all times.

1. Work will be conducted only in the containment level stated in the permit by the permit holder.

1. All workers listed on permit have effective site-specific biosafety training on all the biological agents used and Biosecurity in the permitted lab(s). Use the UWinnipeg Laboratory Safety Orientation Checklist and the biosecurity checklist to document the training, file them in the laboratory and also attach with the permit application.

1. The information provided as part of the biosafety permit application is true and accurate. Any changes to the information given as part of the biosafety permit application shall be updated within 30 calendar days of the change (personnel, biological material, or procedure).

1. The following documents are required and must be maintained in applicant’s lab in a format and location which is readily accessible to all workers in the lab, and to institutional and federal inspectors without prior notice of audit or inspection:

• A signed copy of the permit holder’s biosafety permit application
• A copy of the Public Health Agency of Canada (PHAC) biosafety guidelines (electronic copy is acceptable)
• A copy of the Human Pathogens and Toxins Act and Regulations (electronic copy is acceptable)
• A copy of the University of Winnipeg Biosafety Policy and Procedures Manual (work is in progress) (electronic copy is acceptable).
• A copy of site-specific biosafety training records for all lab personnel and authorized students in research labs
• Pathogen Safety Data Sheets for all biohazard agents present in the laboratory or to which workers are at risk for occupational exposures (http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/index-eng.php).

1. The following documents must be conspicuously and visibly posted in the permitted labs:

• A signed copy of all biosafety permits applicable to space upon the issue
• An up-to-date lab door placard
• A copy of the appropriate University of Winnipeg Post-Exposure Protocol or an approved alternate procedure.

1. Report immediately to the Safety Office and Biosafety Officer if there is:

• Any reason to believe that a biological material (e.g. toxins, genetically modified organism or microorganism) has been released inadvertently from the facility;
• Any inadvertent production of a human, animal, or plant pathogen or toxin in the course of an activity;
• Any reason to believe that an incident involving a human pathogen or toxin that is in your possession has, or may have, caused an exposure to an individual or disease in an individual;
• Any reason to believe that a human, animal, or plant pathogen or toxin that was in your possession has been stolen or is otherwise missing;

*Risk Group Determination using:

1. ePATHogen – Risk Group Database from the Public Health Agency of Canada, https://health.canada.ca/en/epathogen
2. PHAC Pathogen Risk Assessment, https://www.canada.ca/content/dam/phac-aspc/documents/services/canadian-biosafety-standards-guidelines/guidance/pathogen-risk-assessment/pathogen-risk-assessment.pdf
3. PHAC Pathogen Risk Assessment, https://www.canada.ca/content/dam/phac-aspc/documents/services/canadian-biosafety-standards-guidelines/guidance/pathogen-risk-assessment/pathogen-risk-assessment.pdf
4. Human Pathogen and Toxins Act Schedules 2-4, https://www.canada.ca/en/public-health/corporate/mandate/about-agency/external-advisory-bodies/list/advisory-committee-human-pathogens-toxins/2017-schedule-2-4-ac-hpt-recommendations.html
5. ATCC or other vendor information