3-Step Process - Biohazard Permit Application

Step 1: Classify

Find the human and animal risk group of the biological agent of interest by accessing Public Health Agency of Canada's (PHAC) ePATHogen database. If working with potentially infectious human or animal specimens or environmental samples, first develop a list of potential or tentative pathogens. Then classify each listed biological agent by accessing the ePATHogen database. 

1. If any of the pathogens of interest are Risk Group (RG) 2, complete a Level 2 permit application (See below). 
   • Note: If you have three RG1 & one RG2 human/animal pathogen in accordance with the ePATHogen database or pathogens requiring enhanced containment in accordance to Enhanced containment (CL2+) SOP, complete a Level 2 permit application.
2. If the projects involve only RG 1 materials/biological agents, the work can be registered as Level 1 permit application using the BSC-11 Risk Group 1 application. 

If you will only be storing the biohazardous materials, register using the BSC-13 Risk Group 1 and 2 Storage application form. 

Note: Work with similar risk groups scope and intent of research can be consolidated as a single biohazard application. RG1 organisms may be included within a Level 2 permit. Projects requiring Enhanced Containment should be outlined in a stand-alone application. We currently do not have a licence to use RG3 organisms at the University of Guelph 

Step 2: Complete the required forms

For a Level 2 permit application, complete:

1. Biohazard main application
   • For Biohazard main form completion, review the “Instructions for completing Biohazard permit RG-2 application” 
2. Required supplementary forms
   • For instance: BSC -1 for the pathogens to be included, BSC-2 for cell lines and BSC -7 for animal use and so on. Note that sections under 6.0 of the main application provide direction on the required attachment options. 
   • If inoculating animals with a biohazard, a BSC -7 form must be signed by the Manager, Campus Animal Facilities

Additionally, provide the following supporting information: 

1. Pathogen Safety Data sheet (PSDS): PSDS for each pathogen listed in section 6.1 of the main application or Safety Data Sheets (SDS) for cell lines or ATCC strains. PSDSs are available on the PHAC Website.
2. Biohazard work specific manual: This could be a lab or department manual but should list all relevant procedures and PPE that will be used to process and/or manipulate biohazards. The manual should have the current date of writing and/or review and responsible person listed. Please do not include University Biosafety manual.
3. References: This should be provided as required (for instance, if working with human/animal specimen, provide reference(s) to support your tentative list of biohazards). Reference(s) could also be provided to support your procedures, required PPE etc. if these are not standard. 
4. Complete Annual Refresher Emergency Response plan (ARER), Biological Spill response plan template and Pathogen status inventory form: Please note Biosafety videos and established SOP’s for biosafety-related emergencies are available on Biosafety webpage. These must be reviewed by the PI and/Investigative staff prior to completing the ARER. 
5. Curriculum vitae (CV): For first time biohazard permit applicants, the PI’s background regarding work with biological materials covered under the Biosafety program (microorganism, cell lines, recombinants, etc.) is to be included. Alternatively, a link to relevant experience/background provided. E.g. Faculty webpage. 
6. Emergency contact form: This should be submitted only if a copy was not submitted to the admin of your department (preferable).

Complete Agreement on Biosafety (AOB) for PI and each investigative staff.

Instructions to register for EHS courses and online course access are available on the Biosafety Training and Registration page.

For both Level 1 and 2 permit applications:

General Training

All training listed below must be completed by the PI and Investigative staff for both Level 1 & 2 permits:

1. Lab safety (also offered in-class) 
2. Online Biosafety for Principal investigator or Investigative Staff 
3. Workplace Hazard Management Information System (WHMIS)
4. Health Safety Awareness training for Supervisors or Workers 

Instructions to register for EHS courses and online course access are available on the Biosafety Training and Registration page.

Lab and/or program specific training will be dependent on the activities. For example, if shipping or receiving biohazardous materials, TDG training may be required. 

Additionally, an Agreement on Biosafety (AOB) - must be completed for the PI and each investigative staff. 

 For Level 1 permit application:

• Complete BSC-11 Risk Group 1 application

Step 3: Submit the forms to the Biosafety officer (BSO):

Forms are pdf-fillable and should submitted electronically via email at bso@uoguelph.ca. Paper copies are not required. Forms are screened for completeness, followed by a preliminary content review by the BSO. Level 2 applications are then reviewed by the Biosafety committee. 

Transfers/imports/purchases should occur only after approval of the Biohazard permit.