Biosafety

here are new forms to submit biosafety permit applications through RISe. 

The Biosafety Committee has two main reasons for updating the forms. Firstly, after five years of use, both researchers and reviewers have found redundancies, inefficiencies, and common pitfalls within the existing forms. We have taken this feedback and have produced a form that streamlines the application process. The second reason is to enable UBC to meet its responsibilities under the Human Pathogens and Toxins Act (HPTA), Public Health Agency of Canada, Canadian Food Inspection Agency, Environment Canada, WorkSafe BC, and the requirements of the granting agencies.

Under HPTA, organizations using biohazardous materials (RG2 and RG3) are required to register and obtain a licence from the Public Health Agency of Canada. UBC is required to track and report on several elements associated to the work on campus including but not limited to: local risk assessments, inventories, authorized users, training, and biosecurity. We have incorporated all of these factors in the biosafety application. If your biosafety permit application has been completed properly and maintained, then most of the elements required by PHAC are covered.

There are now be five types of Biosafety Permit Application forms to streamline the application process and enable UBC to meet its responsibilities with government regulations and granting agencies. These are:

1. RG1 – this includes RG1 microorganisms, animal cells, genetically modified RG1 organisms, recombinant DNA. 
   UBC requires RG1 work to be reviewed because some funding agencies require the tracking of recombinant DNA work, genetically engineered materials, and it helps the Biosafety Committee to ensure that every laboratory has appropriately assessed the risks of the organisms they are using.
2. RG2 – this includes RG2 microorganisms, human cells or cell lines, other primate body fluids and tissues, genetically modified RG2 organisms, toxins listed in HPTA. The hyperlinks provide guidance but are not complete lists.
3. RG3 – this includes RG3 microorganisms. An example: cultured HIV is RG3 but HIV positive blood is considered RG2 with special precautions.  
4. Environmental hazards – Environmental biological hazards are now included in the Biosafety Committee purview to help UBC become compliant under the various environmental regulations, both federally and provincially. This includes invasive plants, plant pests, aquatic pests, plants with novel traits, and genetically engineered organisms that are not classified as RG1, RG2 or RG3. Safety & Risk Services has developed a tool for determining if your samples fall under this category. For more information, please contact Sharlene Eivemark / 604-822-9527, Biological and Radiation Safety Advisor, Safety & Risk Services.
5. Teaching Labs – Teaching labs involving any of the materials listed in the other categories. This simplified expedited application allows UBC to meet its regulatory tracking requirements and ensures that each of our students is being trained in safety from the start.  

Note for applicants: 

If you are using both RG1 and RG2, only a RG2 application needs to be filled out.
If you are using plant pathogens then please fill out an RG1 application.
Use the provided Environmental Hazard Tool, to determine if your organism is considered an invasive plant, plant pest, or aquatic pest.

Genetically engineered organisms are defined as:

The plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism,
the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorganism, or one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for that plant, animal or microorganism.

Note: Tracking genetically engineered organisms has always been required, but will now be specifically tracked using RISe. Due to their minimal risk we are excluding detailed lists for non-pathogenic E.coli, Arabidopsis, Chlamydomonas, Populus, and transgenic mice. If there are other organisms that should be excluded, please contact Sharlene Eivemark / 604-822-9527, Associate, Research Compliance & Occupational Hygiene, Safety & Risk Services 

A biosafety certificate is issued when all prescribed requirements are met and indicates the minimum level of containment necessary. A biosafety certificate is valid for five years unless there are significant changes in the research program, facility or research personnel, in which case notification must be submitted to the Committee. The Office of Research Services cannot release grant funding unless a biosafety certificate has been issued by the Biosafety Committee.

Applications for review and certification by the Biosafety Committee must be submitted electronically on RISe. When applying for a biosafety certificate, the researcher must establish the Risk Group and Containment Level of the agent and must present a Biosecurity Plan. A biosecurity plan is implemented to prevent theft, misuse or intentional release of pathogens. The type of biosecurity plan implemented will depend on the nature of the facility, type of research and diagnostics conducted and the local environment. Key features of a biosecurity plan should include:

• Facility security
• Inventory of biological materials
• Emergency procedures for security incidents (e.g., stolen, misplaced, misused materials)

For more information on biosecurity, please contact Sharlene Eivemark.

Before beginning any work, investigators must complete a proper risk assessment to determine the appropriate work procedures and containment level to safely complete the research. A risk assessment considers the biological agent, the host (or person working with the agent) and the environment.

Biological Agent: The risk associated with using bacteria, viruses, fungi and other pathogenic organisms varies with each agent and its method of use. Accordingly, the Public Health Agency of Canada (PHAC) developed the Canadian Biosafety Standards and Guidelines to classify biological agents into four Risk Groups: 

• Risk Group 1: Low individual and community risk
• Risk Group 2: Moderate individual risk, low community risk
• Risk Group 3: High individual risk, low community risk
• Risk Group 4: High individual risk, high community risk

Consult the Canadian Biosafety Standards and Guidelines or Schedule 1-5 of the Human Pathogen Toxins Act to determine the Risk Group of a biological agent. Visit the PHAC website to consult Pathogen Safety Data Sheets (PSDS) for infectious agents.

Host: Of primary concern in assessing host factors are the worker’s medical status, attitudes and experience with biological materials. A worker with special health conditions or poor immune status could be more at risk when working with biological materials; for more information, contact Occupational & Preventative Health. Risk increases substantially when workers have not been adequately trained or informed of the risks associated with their work. 

Environment: This element of the risk assessment considers the manner and location in which the biological agent is manipulated, how it is manipulated, and specifics such as the quantity of the agent, aerosol production and the use of sharps and needles.

Determine the required Containment Level after the agent’s Risk Group is identified. Establishing a Containment Level minimizes risk by considering the operational requirements (e.g., training, SOPs, engineering control, personal protective equipment) and physical requirements (e.g., lab design, barriers) of the biohazard.

A biological agent’s Risk Group is not the sole determinant for establishing a Containment Level.  The risk group system does not account for the procedures employed during the manipulation of a particular organism or the host factors. Depending on host and environmental factors, the containment level may be higher or lower than the agent’s risk group.

The PHAC Canadian Biosafety Guidelines (Local Risk Assessment) establishes four containment levels:

1. Containment Level 1 (CL1) agents require no special design features beyond those suitable for a well-designed and functional laboratory.
2. Containment Level 2 (CL2) agents are primarily transmitted through the ingestion, inoculation and mucous membrane routes, but are not typically airborne.
3. Containment Level 3 (CL3) agents may be transmitted by an airborne route, often have a low infectious dose to produce effects and can cause serious or life-threatening disease. CL3 facilities require primary and secondary barriers to minimize the release of infectious organisms.
4. Containment Level 4 (CL4) agents have potential for aerosol transmission, often have a low infectious dose and produce very serious and often fatal disease with no available treatment or vaccine. CL4 facilities are functionally isolated and, when necessary, structurally independent of other facilities.

A biosecurity plan is implemented to prevent theft, misuse or intentional release of pathogens. The type of biosecurity plan that is created and implemented, will depend on the nature of the facility, the type of research and diagnostics conducted and the local environment. Personnel from varying levels of administration can be involved in the creation of the biosecurity plan. Key features of a biosecurity plan should include:

• Facility security;
• Inventory of biological materials; and
• Emergency protocols for security incidents.

General biosecurity requirements for CL1 and CL2 work

For CL1 and CL2 work, the UBC Biosafety Committee needs to know:

• Biological material(s) being handled by the lab; and
• Room number(s) of where they are being handled.

Please note that an exhaustive list accounting for each tube is not currently needed for any Risk Group 1 or 2 agents, although it is recommended for pathogens.

Recommendations for CL1 and CL2 pathogens

A pathogen is defined as an agent that can cause disease in humans or animals. When working with pathogens, labs should have an inventory of all vials, plates and tubes that are being stored. Working solutions of the agents that are currently being used for on-going experiments do not need to be inventoried. Access to the pathogens must be restricted to specific laboratory personnel and a tracking system must be established to determine if vials are unaccounted for. Personnel who do have access to the pathogens must be documented and kept on file.

Facility Security

In this part of the plan, strategies used to prevent the entry of unauthorized personnel and the theft of pathogens must be examined. For instance, is access to pathogens restricted (i.e., kept under lock and key) and whether the facility has specific security protocols in place to minimize the entry of unauthorized personnel (i.e., key card access, identity badges, protocols for locking doors).

Protocols for Security Incidents

In those cases where there have been unauthorized personnel entering the building or pathogen samples stolen, misplaced, misused or intentionally released, an emergency protocol must be in place. In this protocol, it must state a clear procedure on who needs to be contacted about the theft or unauthorized entry (e.g., supervisor, security, law enforcement agencies, UBC Safety and Risk Services - 604-822-9527).

Biosafety applications must be submitted through RISe. For assistance accessing RISe, please email risesupport@ors.ubc.ca. 

Applications are due by 8:00 a.m. on the "Submission Deadlines" dates indicated below. Please note that new applications are first routed for departmental review and approval so please allow sufficient time for that process. Applications received by each deadline will be reviewed at the corresponding monthly Biosafety Committee meeting.