Biosafety

The University has an obligation to its community, funding agencies and the public at large to conduct its teaching and research activities in a responsible and accountable manner. To that end, the Nipissing University Biosafety Committee (the Committee) is mandated by the office of the Provost and Vice- President, Academic and administered by the office of Graduate Studies, Innovation and Research to provide policy direction and make recommendations to the Provost and Vice President, Academic for all matters pertaining to the use of biohazardous materials in research and in teaching.

The Committee monitors the use of biohazardous material in teaching and research by performing the following duties:

• Develop and maintain University policies for handling biohazardous materials in compliance with internal and external standards including: Public Health Agency of Canada (PHAC), Canadian Food Inspection Agency (CFIA), National Institute of Health (NIH), Occupational Health and Safety Act and Regulations (OHSA), and Nipissing University’s policies;
• To ensure that all users, are fully aware of the guidelines and of the nature of containment required for research/teaching;
• Review and approve applications for use of biohazardous materials;
• Advise the Provost and Vice President, Academic on matters relating to biohazards.

Nipissing University Biosafety Committee 

Terms of Reference

Updated May 2021

Mandate 

The University has an obligation to its community, funding agencies and the public at large to conduct its teaching and research activities in a responsible and accountable manner.  To that end, the Nipissing University Biosafety Committee is mandated by the office of the Provost and Vice President, Academic and Research and administered by the office of Graduate Studies and Research to provide policy direction and make recommendations to the Provost and Vice President, Academic and Research for all matters pertaining to the use of biohazardous materials in research and in teaching.   

Membership 

The Biosafety Committee has representation from members who have expertise and/or interest in biosafety at Nipissing University. Members are appointed for a two-year period with the possibility of renewal by the Provost and Vice President, Academic and Research as follows:    

• Human Resources Generalist - Health, Safety and Wellness/BSO 
• Laboratory Technician 
• Two (2) faculty** members who represent two different academic departments 
• Senior administrator reporting to the Provost and Vice President, Academic and Research; 
• One (1) member at large from the community 

** The chair will be a member of faculty who is elected by the membership and appointed by the Provost and Vice President, Academic and Research 

Reporting Structure 

The Biosafety Committee is advisory to the Provost and Vice President, Academic and Research. The committee, through the chair shall report at least annually to the Provost and Vice President, Academic and Research, summarizing the activities of the year.  

Meetings 

Meetings shall be held twice a year in the spring and the fall. The chair reserves the right to call additional meetings as required. Quorum consists of at least three members of the biosafety committee and decisions will be made by consensus.  If consensus is not achieved, outside advice may be requested by the Chair.   

Duties 

The Committee monitors the use of biohazardous material in teaching and research by performing the following duties: 

• Develop and maintain University policies for handling biohazardous materials in compliance with internal and external standards including: Public Health Agency of Canada (PHAC), Canadian Food Inspection Agency (CFIA), National Institute of Health (NIH), Occupational Health and Safety Act and Regulations (OHSA), and Nipissing University’s policies; 
• To ensure that all users, are fully aware of the guidelines and of the nature of containment required for research/teaching; 
• Review and approve applications for use of biohazardous materials. 
• Advise the Provost and Vice President, Academic and Research on matters relating to biohazards; 

Note: The biosafety committee will review and amend the terms of reference annually at the spring meeting.

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Section 3 of the Human Pathogens and Toxins Regulations states: If the applicant for a licence is a person who intends to carry out scientific research, before the Minister issues the licence they must determine that the person has developed a plan that sets out how they will administratively manage and control biosafety and biosecurity risks during the term of the licence. To that end, Nipissing University and the Biosafety Committee have developed a Plan for Administrative Oversight that has been vetted and approved by Public Health Agency of Canada (link to document below). 

Plan for Administrative Oversight

All facilities, teaching and research, that intend to engage in the use of risk group 2 or greater, biohazardous substances must be registered with the Public Health Agency of Canada (PHAC) prior to becoming operational. 

Regardless of the risk group, a risk assessment and permit application is required for all research or teaching activities involving the use or manipulation of potentially hazardous biological agents (including viruses, bacteria, fungi, parasites, recombinant DNA, prions and other microorganisms/genetic systems, and human and animal tissues, cells, blood and body fluids) and materials containing such agents and which are:

• supervised or conducted by employees or members of the University, or 
• are supported by funds provided by or through the University.

A Biosafety permit application form must be completed and submitted to the Biosafety Officer (BSO). The application form is reviewed by the BSO to ensure completeness.  Once the form is complete, it is submitted to the Biosafety Committee for review and assessment of the risk level at which the proposed activities should be conducted at, as well as safeguards and protocols that may be required to ensure the safety of the University community. The submission of a Biohazard permit application form implies a willingness to allow the BSO to visit the laboratory in order to ensure compliance with the Nipissing University Biosafety policies and procedures manual and the Canadian Biosafety Standards and Guidelines and any other current Canadian regulatory statute pertaining to the handling of biohazardous material.

For activities involving risk group 2 and 2+ biohazardous substances, the BSO will inspect and conduct a Biosafety audit of the worksite to ensure it meets the operational and physical requirements as per the current regulations and standards of the Public Health Agency of Canada and/or the Canadian Food Inspection Agency.

Once the permit application is approved , a permit, valid for up to 5 years, subject to annual review, will be issued by the BSO. During this period, the BSO will audit the activities to ensure compliance with the permit conditions.  If the activities involving biological agents are to be altered or modified in any way from that specified in the previous submission, a permit amendment form must be completed and submitted to the BSO for review  and approval by the Biosafety Committee before those changes can be implemented.  All activities involving the biological agent must cease until the Biosafety Committee has approved the permit amendment.

A visual overview of the Permit Application/Renewal/Amendment Process can be found here;

A visual overview of the Permit Decision Process can be found here;

The Biohazard Permit Application Form & Risk Assessment can be found here;

The Biohazard Material Use Permit Annual Renewal and Amendment Form can be found here;​

The Training Record for Permit Application can be found here.

Before making any arrangements to either import or transfer a human or animal pathogen or toxin, the BSO must be notified.  This is to ensure that sufficient safety precautions for handling the human or animal pathogen or toxin are in place.

Before making any arrangements to either export or transfer a human or animal pathogen or toxin within Canada, the BSO must be notified.  In addition, persons transferring human pathogens or toxins within Canada must take reasonable care to ensure that the intended recipient is licensed to work with the agent or otherwise exempted from the requirement to hold a licence.  In order to export pathogens or toxins, reasonable care must be taken to ensure that the intended recipient will follow applicable biosafety and biosecurity standards and policies in the foreign jurisdiction.  To that end, prior to exporting or transferring the pathogen or toxin, a Biohazardous Agent Transfer Notification form must be filled out and submitted to the BSO.  The BSO will then provide further advice and instruction.   

No.  Nipissing University has a single site licence that covers all laboratory space for work with RG2 human or animal pathogens and toxins.  However, before any work with human or animal pathogens or toxins can begin, approval for that work must be granted by the Biosafety Committee.  To obtain approval a Biohazard Permit Application form must be filled out and submitted to the Biosafety Committee through the BSO.

Before beginning any work the BSO must be notified and a Biohazard Permit Application form must be filled out and submitted to the Biosafety Committee through the BSO.  The Biosafety Committee will assess the hazards and risks associated with the proposed work and determine the appropriate safety measures that need to be incorporated into the work.  A permit or letter will be issued, depending on the containment level required to do the work.

The laboratory must first be assessed by the BSO to ensure that the space is suitable for working with RG2 material.  If the BSO is satisfied that RG2 work can be safely accommodated in the laboratory space, the licence holder (Provost and Vice President, Academic and Research) will be notified and the license will be updated to include the new RG2 work space.  Once the licence update has been approved by PHAC, a Biohazard Permit Application form must be filled out and submitted to the Biosafety Committee through the BSO.  The Biosafety Committee will assess the hazards and risks associated with the proposed work and determine the appropriate safety measures that need to be incorporated into the work. A permit or letter will be issued, depending on the containment level required to do the work.

Contact the BSO to ensure that the risk group of the pathogen will allow the organism to be cultured under the terms of our PHAC licence.

You must immediately notify the BSO and ensure that the organism is handled and stored appropriately.  Within 30 days it must either be transferred to a licenced laboratory authorized to conduct controlled activities with that organism or it must be destroyed.

The training required depends on what you will be working with. Please contact the Laboratory Safety Coordinator to arrange for your training (training requirements outlined below).

1. RG1 material:  WHMIS 2015, Basic Laboratory Safety Training and CL1 Biosafety Training.
2. RG2 material: WHMIS 2015, Basic Laboratory Safety Training and CL2 Research Biosafety Training.
3. Human blood or Other Potentially Infectious Material (OPIM) including saliva: WHMIS 2015, Basic Laboratory Safety Training, CL1 Biosafety Training and Blood Borne Pathogen Safety Training.
4. Animals: you will also require Animal Care Training.

While RG1 organisms are not specifically covered by the Canadian Biosafety Guidelines, Nipissing University policy requires any research involving a human or animal pathogen or toxin to be approved by the Biosafety Committee.  To obtain approval a Biohazard Permit Application form must be filled out and submitted to the Biosafety Committee through the BSO. ​ 

For more information please contact the HR Generalist: Health, Safety & Wellness Ext. 4811