Biosafety

Any activities conducted at UBC facilities or affiliated institutions that involve biohazardous materials must be reviewed and approved by the UBC Biosafety Committee prior to the start of the research project.

This includes research and teaching with: cultured animal cells, cell lines, recombinant DNA, plasmids, parasites, toxins, microorganisms (including viruses and bacteria), and primate body fluids (including blood), and PRIONS.

All research activities are subject to this review regardless of funding source. Applications for review and certification by the Biosafety Committee must be submitted electronically on RISe.

The Office of Research Services provides administrative support in applying for a Biosafety Certificate. UBC Risk Management Services (formerly the Department of Health, Safety and Environment) provides technical expertise to researchers working with biohazardous materials, provides biosafety training, and reviews all procedures and facilities involving biohazardous materials.

Open the accordions below to navigate detailed policies, procedures, FAQs and other information regarding the use of biohazardous materials in teaching and research.

If you are a researcher seeking assistance with obtaining a Biosafety Certificate, please contact: Lynn Macdonald, Manager, Animal Care & Biosafety Committees (604-827-5111) or Fred Woo, Animal Care & Biosafety Assistant (604-827-5115).

If you are a researcher seeking biosafety training or technical support for a biosafety issue, please contact Stephanie Thomson, Biosafety Advisor, Occupational and Research Safety, Risk Management Services (604-822-9527).

Biosafety FAQs

When do I need to contact Risk Management Services (formerly the Department of Health Safety and Environment) regarding biohazards?

Contact  Stephanie Thomson, Biosafety Advisor, Occupational and Research Safety, Risk Management Services (604-822-9527) to request training or technical expertise with biohazardous materials, or to request a review of procedures or facilities involving bio-hazardous materials.

When do I need to contact the Office of Research Services regarding biohazards?

Contact Lynn Macdonald, Manager, Animal Care & Biosafety Committees (604-827-5111) or Roger Chow, Animal Care & Biosafety Assistant (604-827-5115) for assistance with applying for or obtaining a Biosafety Certificate, or with questions about the Biosafety Committee.

Who regulates and determines Containment Level requirements in Canada?

Two federal agencies regulate work with biological materials in Canada. The Public Health Agency of Canada primarily oversees work with human pathogens. The Canadian Food and Inspection Agency oversees work with animal pathogens. 

What if I am working with human blood and body fluids?

Human blood and body fluids are potentially pathogenic and are considered biohazards. Users of these materials must apply for and receive a Biosafety Compliance Certificate prior to use and must complete Laboratory Biological Safety Course administered by UBC Risk Management Services. The materials must be handled under Containment Level 2 protocols.

Human blood samples for experimental use may only be obtained from the following sources:

  1. Commercial vendors
  2. Volunteers other than the User who are not personnel from the User’s lab and who do not have access to the lab.

Human ethics approval must be obtained when using volunteers. For more information about working with blood, please refer to the Standard Operating Procedure entitled Working with Human Blood.

Biosafety Policies, SOPs and Guidelines

Biosafety Policies

UBC IBC 001 Lentivirus Policy
Lentivirus Production Form

Biosafety Non-Compliance Policy

Standard Operating Procedures

  1. Biological Spill Cleanup
  2. Centrifuge Safety
  3. Blood Work
  4. Working with a Class 2 Biological Safety Cabinet

If you need assistance with these documents or if you have any questions, please contact:

Roger Chow, Assistant, Animal Ethics & Biosafety Committees (604-827-5115)
Lynn Macdonald, Manager, Animal Care & Biosafety Committees (604-827-5111)
Stephanie Thomson, Biosafety Advisor, Occupational and Research Safety, Risk Management Services (604-822-9527).

Submitting a Biosafety Protocol

The UBC Biosafety Committee assesses each proposal to determine whether the research falls within the Public Health Agency of Canada’s Canadian Biosafety Standards and Guidelines (CBSG) released in July 2013 and establishes the appropriate level of containment.

The Committee also ensures that the proposed research facility is adequate for the work, confirms that safety equipment (including biological safety cabinets) are functioning properly, and advises on the training required by the faculty and staff conducting the research.  

1. New Biosafety Forms

There 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. So if your biosafety permit application has been completed properly, and is 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 or cell lines, 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 – 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.
    NEW! 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. Risk Management Services has developed a tool for determining if your samples fall under this category. Please click on the link for more information: Environmental Biological Hazards Tool.
  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 Stephanie Thomson

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 four 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, each of which is described in the following sections.

2. Risk Assessment

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 Laboratory Biosafety Guidelines (3rd edition, 2004) 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 PHAC Laboratory Biosafety Guidelines or Schedule 1-5 of the Human Pathogen Toxin 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 Workplace Health Services. 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.

3. Containment Level

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 Laboratory Biological Safety Guidelines (3rd Edition, 2004) 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.
4. Biosecurity Plan

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 being handled by the lab; and
Room numbers of where they are being handled.

Please Note:  An exhaustive list accounting for each tube is not currently needed for any Risk Group 1 or 2 agents, although we do recommend it 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 somehow (i.e., kept under lock and key) and does the facility have 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, 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 (i.e., Supervisor, security, law enforcement agencies, HSE etc.)

5.  Submission Deadlines

Biosafety applications must be submitted through RISe. For assistance accessing RISe, please email risesupport@ors.ubc.ca or call Roger Chow, Animal Care and Biosafety Assistant (604-827-5115). 

Applications are due by 8:00 a.m. on the "Submission Deadline" date indicated below. Applications received by each deadline will be reviewed at the corresponding monthly Biosafety Committee meeting.

Submission Deadline:  January 20, 2016

Meeting Date: January 27, 2016

Submission Deadline: February 17, 2016

Meeting Date: February 24, 2016

Submission Deadline: March 23, 2016

Meeting Date: March 30, 2016

Submission Deadline: April 20, 2016

Meeting Date: April 27, 2016

Submission Deadline: May 18, 2016

Meeting Date: May 25, 2016

Submission Deadline: June 22, 2016

Meeting Date: June 29, 2016

Submission Deadline: August 24, 2016

Meeting Date: August 31, 2016

Submission Deadline: September 21, 2016

Meeting Date: September, 2016

Submission Deadline: October 19, 2016

Meeting Date: October 26, 2016

Submission Deadline: November 23, 2016

Meeting Date: November 30, 2016

Submission Deadline: December 7, 2016

Meeting Date: December 14, 2016

 

Biosafety Training

All new faculty members and lab personnel must complete an introductory orientation, in-lab training, and training by UBC Risk Management Services.

Each worker must complete safety orientations for both their facility and lab space, and must be appropriately trained prior to performing any work duties.

Introductory Orientation

An introductory orientation should include the hazards in the laboratory space as well as general facility knowledge such as the location of washrooms, photocopiers, fire exits, etc. This orientation is required by WorkSafe BC’s New and Young Worker Regulation, which applies to any worker who is new to a work site or is under the age of 25.

Supervisors are responsible for creating a checklist to ensure consistent orientations and to document the delivery of training.

In-Lab Training

Supervisors are required to provide in-lab training to all lab personnel to address the specific risks and hazards associated with their work. Federal regulations require the training to be documented and kept on file while the individual is working in the space. Each training document must include:

  1. Name of protocol;
  2. Trainee/Trainer name and signature; and
  3. Date training was completed.

If the trainer or trainee feels that training was insufficient, more training must be provided until the trainee is competent in completing the protocol or procedure.

UBC Risk Management Training

Any personnel working with biological materials (RG1-3) must complete the Laboratory Biological Safety Course and may require the Transportation of Dangerous Goods (TDG) 6.2 course offered by UBC Risk Management Services. Personnel shipping many biological materials must complete the TDG 6.2: Infectious Materials course. Please contact Risk Management (604-822-9527) for more information, or to determine if the course is necessary for you.

Biosafety Committee

The Biosafety Committee assesses each research proposal to determine whether the research falls within the Public Health Agency of Canada’s Laboratory Biosafety Guidelines (3rd Edition 2004) and proposes the appropriate level of containment. 

The Committee ensures that the proposed research facility is adequate for the work, confirms that safety equipment (including biological safety cabinets) are functioning properly, and advises on the training required by the faculty and staff conducting the research.

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 four 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.

Contact Us

For assistance with applying for or obtaining a Biosafety Certificate, or with questions about the Biosafety Committee, contact:

Roger Chow, Assistant, Animal Ethics & Biosafety Committees (604-827-5115)
Lynn Macdonald, Manager, Animal Care & Biosafety Committees (604-827-5111)
Stephanie Thomson, Biosafety Advisor, Occupational and Research Safety, Risk Management Services (604-822-9527).

Fees for Service

There is no charge for applications requiring ethical review that are either unfunded, funded internally (including teaching), or funded by grants from federal/provincial granting agencies or charitable or not-for-profit organizations.

A fee of $600 applies to applications funded by a for-profit agency. The fee is a one-time-only fee for each specific application and covers initial review, annual renewals, and minor amendments for the next three years. Major amendments (after initial approval) involving full review, and a renewal after three years, will be charged $300. If the associated research project is withdrawn prior to the application review the fee will be totally refunded. If the associated research project is withdrawn after the application review, one half of the fee amount ($300) will be refunded.

A Biosafety Certificate will not be issued until fee payment has been received. Normally a cheque for the fee amount will accompany the application submission. In special cases the Director of Research Services may approve invoicing for the fee amount.

The fee may be waived or reduced in special circumstances, upon the recommendation of the Office of Research Services.