Biohazard Safety

The Queen's University Biohazard Committee, on behalf of the University, will determine whether the risk assessment and risk mitigation measures are appropriate for the nature of biohazardous work in progress or proposed, accredit the facilities on an ongoing basis, assist the design of appropriate laboratories, procedures and training of personnel, and serve as an educational resource to members of the University community.

Members of the University community who are contemplating work involving the following biological materials are required to contact the University Biological Safety Officer to begin the process to obtain a Biohazard Permit for this work before such work begins:

•  Human or terrestrial animal pathogens or toxins regulated under the Human Pathogen and Toxin Act (HPTA) (Schedules I, II and III)

•  Biological material regulated by the Canadian Food Inspection Agency

•  Animal material that might contain foreign animal diseases

•  Plant pests or material that might contain such pests

•  Aquatic animal pathogens or material that might contain such pathogens

•  Tissue or fluids of human origin

•  Microorganisms and cultured cell lines regardless of the risk group to which they have been assigned

Permits must be renewed annually.

The Tri-Council Memorandum of Understanding with the University relating to biohazardous research funded by the three federal granting agencies (CIHR, NSERC, and SSHRC) requires compliance with all applicable legislation and regulations, which includes the Canadian Biosafety Standards (CBS). In addition, the University has adopted the CBS, whether or not the work is externally funded and whether or not the sponsoring agency requires such certification.

Committee Terms of Reference (PDF 15 KB)

For information and assistance contact Natalie Roy at royn@queensu.ca.

The University Biohazards Committee is composed of the following members:

Biohazard Permits are required for all research and training activities which involve the use, manipulation and storage of biohazardous material (including, but not limited to, viruses, bacteria, fungi, parasites, recombinant DNA, biological toxins, prions and other micro-organisms/genetic systems, and human and animal tissues, cells, blood and body fluids), and which are:

1. supervised or conducted by employees or members of the University, or
2. conducted on University premises, or in a building or location administer by or under the control of the University, or
3. supported by funds provided by or through the University.

Permits are issued to a Principal Investigator for all the work with biohazardous materials under their supervision, even if it occurs in a shared facility (e.g. shared cell culture rooms will be listed on your biohazard permit; work in an animal facility). The permit is for the specific biohazardous materials, the procedures used with them, and the facility. New materials, procedures, projects, and award titles are to be added to the permit by submitting an amendment event application (through TRAQ).

An application for a Queen's Biohazard Permit is a two-stage process:

1. Review and approval of the application, by the Biohazards Committee, of the research or teaching activity as described in a Biohazard Permit Application. The Committee meets monthly, 9 times per year. Submission and meeting dates.
2. Inspection and approval of the laboratory or facility where the work will be conducted (before work begins).

Biohazard Permit electronic forms and their use is described below. These forms are available on your Queen's TRAQ Researcher Portal

For questions about the TRAQ system contact the TRAQ help team at ext. 78426.

For biosafety questions contact the Biosafety Officer, Raico Lamela at ext. 78820 or by email at lamelar@queensu.ca

The electronic forms can be prepared by:

• Principal Investigators
• Secondary Biohazard contacts
• any biohazard team member who has been given access to the TRAQ/Romeo permit in the system
  • only those requiring access to TRAQ will be given it; other authorized biohazard team members will be recorded outside of TRAQ

Principal Investigators must submit forms:

All forms in TRAQ must be submitted by the Principal Investigator because submitting the form registers their electronic signature in the system's log.

1. New biohazard applications
   • On your TRAQ Researcher Portal click Apply New, then select Biohazard Permit Application Form
   • Answering the questions on the form provides an overview of your application and lab containment facility. The documents that you are to attach contain more detail. There are templates for each of these documents provided on the attachments tab to guide you about what content to include. These three documents are:
     1. Local Risk Assessment and Medical Surveillance Statement
     2. Biohazard Inventory
     3. Lab Specific Training Statement
2. Re-applications for projects that are currently approved
   • required every four years; (you will be reminded at least six weeks before the reapplication is due i.e., two months before the permit expires)
   • start as for a new application above; or if you have done a TRAQ electronic application previously and there are few changes, you may wish to clone it
3. Annual renewal (you will be reminded at the beginning of the month that the renewal is due)
   1. find your active biohazard permit on your Refresher Portal and then click the Events button, select the appropriate form
   2. fill it out
   3. P.I. must submit
4. Amendment Form​
   • to add new biohazardous materials or new procedures that might affect exposure risk or necessitate different risk mitigation measures
     1. find your active biohazard permit on your Researcher Portal and then click the Events button, select the amendment form
     2. fill it out
     3. attach a revised risk assessment document and inventory (use Track Changes to facilitate review)
     4. P.I. must submit
   • change laboratory location
     • ​​follow steps as in above​
   • add a new project/award title with no change in biohazardous materials or procedures just fill out the amendment form and P.I. submits; if there will be changes then follow steps outlined above 
   • change authorized lab personnel
     • Amendments in TRAQ are not required. Instead use forms submitted outside of TRAQ as described below.

Removing personnel form your Biohazard permit:

Email their names to the Safety Technician (Biohazard & Chemical), Natalie Roy at royn@queensu.ca

Adding personnel to your Biohazard permit:

Personnel who work in the lab unaccompanied (i.e. without direct supervision) must be added to a list of authorized lab team members associated with your Biohazard Permit record in the Department of Environmental Health and Safety (outside of the TRAQ system).

• Do not add undergraduate project students who must always be directly supervised by an authorized lab member and who should not be given keys to the lab.

Add personnel when:

1. You have a newly approved Biohazard permit.
2. New personnel have joined your lab.

Steps to follow:

1. Download the two required forms:
   • Laboratory Personnel Attestation and Signature Form (PDF 184 KB)
   • The New Authorized Biohazard Users Form (XLS 12 KB)
2. Attestation to be completed by:
   • each new person
   • each team member after a full reapplication to document that they have read the new approved permit and its attachments
     1. After completing EH&S and lab specific biosafety training and reading the current approved biohazard local risk assessment -- fill out, print, and sign the Biohazard Attestation form.
     2. Scan the form and save it as a pdf with a file name following the convention: PI Last Name, Attestation, Personnel Last Name, First Name, Month Day Year, e.g., Smith Attestation Doe John March 2 2017.pdf
     3. Send the file to your P.I. or Secondary Biohazard Contact
3. Personnel added to permit by:
   • Secondary Biohazard Contact, or Principal Investigator will add personnel to permit:
   1. Fill out the New Biohazard Authorized Users spreadsheet form (unless this is after approval of a reapplication, please only list new people, not your entire personnel list) and save the spreadsheet form, appending to the file name the PI last name and date e.g. New Biohazard Authorized Users Smith May 30 2017
   2. Review the attestation form(s) for completeness and accuracy
   3. Email the form accompanied by an attestation file for each new team member to the Safety Technician (Biohazard & Chemical), Natalie Roy at royn@queensu.ca

Labs are inspected by members of the Biohazards Committee at a frequency determined by their containment level. You will be notified when an inspection will occur.

Preparing for the inspection by doing a self-inspection is your opportunity to ensure that your lab is compliant with PHAC/CFIA/Queen's requirements.

Prior to the inspection download and fill out the appropriate form below for the highest containment level in each lab.

Check each item on the list as either N/A, Yes, or No. Mark any items you wish to discuss with the inspectors or the Biosafety Officer.

Present the completed form to the inspectors from the Biohazard Committee. They will verify some items and discuss your containment practices.

Containment Level 1

• Level 1 Full Form (PDF 304 KB) for your main lab with the highest containment level (i.e. fill out this form if you don't have a level 2 tab)
• Level 1 Short Form (PDF 232 KB) for your other labs

Containment Level 2

• Level 2 Full Form (PDF 336 KB) for your main lab with the highest containment level (i.e. fill out this form for the lab with the most level 2 or 2+work, usually the lab with the biological safety cabinet) 
• Level 2 Short Form (PDF 264 KB) for your other labs

Principal Investigators must develop Emergency Procedures specific to their laboratory and post it in the laboratory where it is clearly visible.  Ensure that all personnel are familiar with the contents of the protocol and that they know where it is posted. 

Ensure that the Emergency Protocol is amended when changes occur and that the revised protocol is posted in the laboratory. A generic version of an Emergency Procedures Document is provided with detailed instructions on how to personalize it for your lab. Please note: An annual review, updating and retraining of your personnel is required. 

For more detailed information in how to work safely with biological material that can be hazardous to people and/or animals please refer to the Biosafety Manual (PDF 1.5 MB).

1. Download this form and customize it for your lab so that it only contains relevant material.
2. Post it in the lab.
3. Ensure that all lab members know the contents and where to find the posted emergency protocol.
   • Retrain on the emergency protocol annually and document the training in your lab training records.

New Employee/Student Safety Orientation Checklist 

1. Download this form. Customize it for your lab to include any additional lab specific training.
2. Use this form to train all new personnel who will work in the lab.
   1. Trainer and trainee to initial each section as it is completed.
   2. Retain this document in your lab training records.

To ensure that proper containment facilities, practices and permits are in place, you must contact the Biosafety Officer before you transfer any biohazardous material from the facility of one Principal Investigator to another, whether it is within Queen's or between different institutions.

1. Initial contact by phone (78820) or email lamelar@queensu.ca is recommended to discuss a potential biohazard permit amendment application and to determine what type of documentation and review will be required.
2. Ultimately a completed transfer form will be needed:
   • Biohazardous Agent Transfer Notification Form (PDF 455 KB)

The Queen’s University Biohazard Committee requires that the Principal Investigator ensure that all personnel have both general and laboratory-specific training in the handling of biohazardous material.

Training Documentation

Training must be documented and the documents retained in the lab or in the departmental office. Copies of training certificates and also departmental or lab specific orientation checklists signed by the trainee and the trainer must be retained for a minimum of 5 years (PHAC CBS section 4.10.10).

The training program is designed:

1. so that training starts as soon as an individual joins a laboratory both for their personal safety and so that they can begin supervised work without waiting for a centralized course;
2. to provide centralized accreditation for biosafety training through the Department of Environmental Health and Safety (EH&S) to ensure that certain information is provided and understood;
3. to promote safety and regulatory compliance;
4. to demonstrate an element of “due diligence” in the institution; and to assist the laboratory should there be an inspection by a regulatory agency.

Training Requirements

Note - Ensure that you understand the material and that you have any questions answered by your Principal Investigator (or designate) or the University Biosafety Officer.

The employee/student may not work unsupervised with biohazardous materials until they have completed the Lab Specific training and the Queen’s Biosafety training requirements described below.

• After you have been trained, your Principal Investigator or the lab member who has been designated as the Secondary Biohazard Contact will request that you be noted as an authorized user of their biohazard laboratory.
• They will submit an email to the Biosafety Officer with information about your position and with an attestation that you must sign.
• Your attestation will indicate that you have been trained, and will follow the requirements of the Queen’s Biosafety program and the Biohazard Permit on which you are listed.

Undergraduate students who are working on a thesis or project for academic credit are not permitted to work unsupervised (and should not be given keys to the lab). They should still be trained about any hazards present in the laboratory and how these risks are mitigated.

Undergraduate summer students who are paid for their work are considered employees, are covered by different insurance, and may be given unsupervised access to the lab after they are fully trained, at the discretion of their supervisor.

1. Work with your Principal Investigator or their designate to complete the New Employee/Student Safety Orientation Checklist. 
2. The approved biohazard permit and amendments are key sources of biosafety information for work in the lab. The current version of documents must be readily available to personnel, either electronically or as a hardcopy.
   • When reading the documents:
     • For any infectious agent or any material that might contain an infectious agent, take note of the symptoms of infection, the mode of transmission, effective disinfectants and the recommended biosafety level.
     • note any medical conditions that could make an individual more susceptible to the biohazard and inform your supervisor if you are at a greater risk so that measures can be taken for your protection.
       • Remember this information so that if your health status changes you will think to inform your supervisor.
     • Read your Principal Investigator’s approved Biohazard permit form and the attached documents, including the risk assessment, the inventory, the lab specific training statement, and any lab specific biosafety related SOPs and complete any lab quizzes that may be required (e.g. a containment level 2+ quiz).
     • Read any documents listed in the lab specific training statement.
       • This statement will specify which Queen’s Environmental Health & Safety Standard Operating Procedures (SOPs) apply to your laboratory.
       • If there are MSDS (called Pathogen Safety Data Sheet, PSDS) for infectious substances in your lab then read them.
     • Obtain required training through the EH&S website (see details below re: Queen’s Biosafety Training)
     • Obtain any recommended immunization and/or have serum antibody titers checked to confirm that you have responded to an immunization.
3. Locate the Emergency Response Protocol posted in the lab, read it, and learn what to do if you are exposed to a biohazard.
4. Obtain hands-on training in operational procedures for working with and disposing of biohazardous materials.
   • If a respirator (N95 or P100) is required then you need to be fit-tested at EH&S.

1. Learn the location of the links to Biosafety related material on the lab’s computer and/or install them on your own computer and become familiar with the Queen’s EH&S website as a source of information.
2. Read the Queen’s Biosafety Manual and complete the Queen’s Biosafety quiz that is based on the Manual. You will be required to have knowledge of different sections of the Biosafety Manual depending on which quiz you need to write.
   1. Write either the Biosafety – Level 1 quiz OR the Biosafety - Level 2 quiz as required.
   2. A copy of the Biosafety certificate is to be kept by the supervisor with other training records.
3. If your lab uses unfixed human material then you are required to complete the online biosafety course through EH&S on Human Blood, Tissues, and Bodily Fluids and write the 20 question quiz (not just read the relevant SOP-Biosafety-08).

Continuing Education and Refresher training:

1. Annual retraining on your Emergency Response Plan/Protocol (ERP) is required by PHAC.
   • Your ERP is posted in your lab and it should be updated annually, based on the plan/protocol on the Environmental Health and Safety website.
   • We recommend that lab members do this retraining as a group, perhaps during a lab meeting, when the PI receives a notice that it is time to renew their Biohazard Permit.
     • There is a question on the biohazard renewal application to indicate that this has been done.
2. Containment level 2 labs must assess their training needs annually. This is a PHAC regulatory requirement.
   • All personnel must be trained on any changes that are required.
     • In practice most of the changes will be identified at the time of a biohazard permit amendment application and the retraining done then. Nevertheless, the assessment needs to be done annually by your Principal Investigator.
   • There is a question on the biohazard renewal application to indicate that this has been done.
3. WHMIS training must be refreshed annually.
4. Other courses or refresher quizzes related to biohazards may be offered in the future and may become a requirement for the work under your Biosafety permit. Your supervisor and lab secondary biohazard contact will be informed by email if such requirements are implemented.

The federal regulatory agencies, the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) publish laboratory standards that anyone working with human, animal, or plant pathogens (level 2 or higher) must follow. 

• There should be electronic access via a bookmark in your web browser in a biosafety folder, or a hard copy of the standards in the laboratory.
• Note that the Queen’s Biosafety Manual and associated SOPs contain the operational requirements of the PHAC Canadian Biosafety Standards which apply to pathogens and toxins that affect human and terrestrial animal species, so that reading the Queen’s Biosafety Manual and the associated SOPs will fulfill the requirement to have read these documents for most users of risk group 2 pathogens. 
  • For pathogens affecting humans or terrestrial animal pathogens:
    • The Public Health Agency of Canada’s Canadian Biosafety Standards (Third Edition, 2022)
  • For foreign animal diseases, pathogens affecting aquatic species or for plant pests:
    • The CFIA Containment Standards

• Centre for Biosafety and Biosecurity Government of Canada
• Canadian Biosafety Standard (CBS) Third Edition 2022
• Canadian Food Inspection Agency Biohazard Containment and Safety
• American Biosafety in Microbiological and Biomedical Laboratories(BMBL) 6th Edition (2020)
• Pathogen Safety Data Sheets and Risk Assessments (Public Health Agency of Canada)
• American Biological Safety Association

Title: Biological Safety: Principles and Practices
Editors: Diane O. Fleming, Debra L. Hunt.
Edition: 4th ed.
Published: Washington, D.C. : ASM Press, c2006.
Location: Bracken Health Sciences
Call Number: WA485 .B615 2006

Title: Disinfection, Sterilization, and Preservation
Editor: Seymour S. Block.
Edition: 5th ed.
Published: Philadelphia : Lippincott Williams & Wilkins, c2001.
Location: Bracken Health Sciences
Call Number: QV220 .D611 2001

If there is an exposure incident for which you have a Standard Operating Procedure that indicates you should contact Walsh and Associates during normal business hours, contact their main office in Belleville at 613-966-4114.

• Outside of those defined incident types, or if unable to contact Walsh and Associates, if there is an exposure incident requiring urgent medical attention then workers should go to the Kingston Health Sciences Centre – Kingston General Hospital (KHSC – KGH) Emergency. Location of the Emergency Room Entrance (Google Maps) at Kingston General Hospital.

Routine biohazard related matters:

Queen's employees and students working in or around laboratories with biohazards may use the services of the Walsh and Associates Occupational Health Services clinic for routine matters such as:

• work-related immunizations and antibody titre testing

• respiratory assessments related to respirator use for those with certain medical conditions
• medical counselling and serum testing as necessary for certain biohazard exposure incidents for which a Queen’s SOP has been written e.g. exposure to a non-human primate or to human blood

For more information, including how to make appointments or how to create an SOP for specific potential hazard exposure incidents, see the document describing Walsh and Associates Occupational Health Services. (PDF 471 KB)