Biosafety

To ensure the safety of students, faculty, staff, the community and the environment when using biohazardous materials under the auspices of Simon Fraser University, and to facilitate research, teaching and testing in compliance with the applicable regulations and standards outlined below.

Biological Materials

1. "Biohazardous Materials" are defined as biological agents and materials that are potentially hazardous to humans, animals and other forms of life. They include known pathogens and infectious agents including bacteria and their plasmids and phages, viruses, fungi, mycoplasmas, and parasites; cell lines, animal remains, and laboratory animals (including insects) which might harbor such infectious agents, primate body fluids and plant materials. Also included are nucleic acids used in procedures such as recombinant DNA and genetic manipulations;
2. "Human materials" are defined as human blood, blood products, blood components, body fluids, tissues or organs;
3. "Animal materials" are defined as animal blood, blood products, blood components, body fluids, tissue or organs;
4. "Plant materials" are defined as plant pathogens, transgenic plants, plant toxins and exotic plants;
5. "Recombinant DNA"are defined as molecules constructed by joining natural or synthetic DNA or RNA segments to DNA or RNA molecules, able to replicate in a living cell.

Biosafety Containment Levels

Biosafety containment levels are described in general terms. Health Canada Laboratory Biosafety Guidelines apply except in cases where the research is funded by institutions which require containment practices that conform to those specified by the US CDC.

6. "CL1" applies to a basic microbiology laboratory, where work may be done on an open bench top;
7. "CL2" applies to a laboratory that handles agents requiring containment level 2. The primary exposure routes associated with organisms requiring level 2 containment are ingestion, inoculation, and mucous membranes. Although these agents are less commonly transmitted by airborne routes, the generation of aerosols must be avoided through use of biosafety cabinets, sealed rotor centrifuges as well as appropriate personal protective equipment;
8. "CL3" applies to a laboratory that handles agents requiring containment level 3. These agents may be transmitted by the airborne route, often have a low infectious dose to produce effects and can cause life threatening disease. Containment level 3 emphasizes additional primary and secondary barriers to minimize the release of infectious organisms into the immediate laboratory and the environment, such as HEPA filtration of exhausted laboratory air and controlled laboratory access.

Regulators

9. "PHAC" Public Health Agency of Canada;
10. "CFIA" Canadian Food Inspection Agency;
11. "NIH" National Institutes of Health;
12. "TDG" Transportation of Dangerous Goods
13. "WorkSafeBC" WorkSafeBC, Occupational Health and Safety Regulation;
14. Metro Vancouver.

Administrative Requirement

15. "Biosafety Permit" is defined as the document certifying approval by the Biosafety Committee for use of biohazardous materials under specified conditions. Biosafety Permits are granted to SFU faculty or adjunct faculty members proposing to carry out research or teaching involving biohazardous material.

Personnel

16. "Principal Investigator (PI)" is defined as the SFU faculty member (or acceptable equivalent as defined in other SFU policies) in charge of a research or teaching project;
17. "Biosafety Officer" shall be appointed by the Vice President, Research, shall be qualified to assume responsibility for the SFU Biosafety Program, and give technical advice on projects and laboratory facilities involving biohazards;
18. "Certified User" is defined as the individual whose name appears on the approved Biosafety Permit;
19. "Laboratory Workers" are defined as all employees, students and visitors conducting research or educational activities under the auspices of SFU in SFU laboratories involving "biohazardous materials" as defined above.

This policy applies to all research, teaching and testing involving biohazardous material that is undertaken under the auspices of SFU and/or using the resources of SFU. All projects must have an SFU faculty member (or equivalent as defined in 2p above) as PI. Where the SFU Biosafety Committee grants "in principle" approval for research involving biohazards at another institution, a copy of that institution’s permit, for the research, must be filed at SFU.

The University adopts standards compliant with:

1. the Memorandum of Understanding between the three Canadian federal granting agencies and Institutions that receive their awards;
2. the policies and procedures of SFU and the SFU Biosafety Committee;
3. all relevant federal and provincial regulations (Public Health Agency of Canada, Canadian Food Inspection Agency);
4. the National Institutes of Health;
5. WorkSafeBC; and
6. Transportation of Dangerous Goods

1. Authority

                    The SFU Biosafety Committee has the authority, on behalf of the Vice-President, Research, to:

1. stop immediately any use of biohazardous material which deviates from the approval outlined in the Biosafety Permit or is deemed to be in non-compliance with the applicable standards as in part 4.

2. Responsibility

1. The day-to-day requirement to comply with safe use of biohazardous materials in research and teaching under the auspices of SFU is the responsibility of the PI.
2. All lab workers using biohazardous materials in research or teaching must have the necessary expertise and appropriate training in accordance with the policies of SFU and Standards outlined in part 4. The Biosafety Officer in consultation with the SFU Biosafety Committee will decide upon the appropriate methods of achieving the appropriate expertise and training levels.
3. The acquisition of all biohazardous materials (by purchase, culture or transfer from another source) must be arranged in accordance with protocols approved by the SFU Biosafety Committee.
4. The disposal of all biohazardous materials must be in accordance with protocols approved by the SFU Biosafety Committee and in compliance with all relevant federal, provincial and Metro Vancouver regulations and guidelines.
5. The Biosafety Officer, in close collaboration with and support of the SFU Biosafety Committee, is responsible for monitoring the compliance of researchers and instructors with SFU policy and the terms of the approval of their projects. If the Biosafety Officer observes or becomes aware that relevant regulations or guidelines are not being followed in any teaching program or research study, she/he advises the Principal Investigator so that prompt remedial action can be taken. In the event that this is not done to her/his satisfaction, the Biosafety Officer will alert and consult with the SFU Biosafety Committee. In circumstances where the Biosafety Officer is of the opinion that the situation presents an immediate significant risk, the Biosafety Officer may take whatever action she/he considers necessary to remedy the situation. The Biosafety Officer keeps the SFU Biosafety Committee Chair and the Vice President, Research fully informed of such incidents and the reason for the action taken. She/he may also, at her/his discretion, seek the advice of PHAC, CFIA, or other experts as may be appropriate.
6. The Biosafety Officer maintains up-to–date records of all Biosafety Permits, approved locations, certified users, containment equipment, equipment certifications and personnel training. The Biosafety Officer reports, at least yearly to the Chair of the SFU Biosafety Committee with a summary of such records, and granting agencies as required.
7. The SFU Biosafety Committee ensures that researchers use appropriate containment facilities for the proposed research involving biohazardous materials.
8. All proposals involving the use of biohazardous materials in research and teaching require the prior approval of the SFU Biosafety Committee. The detailed responsibilities and powers of the SFU Biosafety Committee are those set out in its Terms of Reference and its Procedures. These are published and may be modified from time to time under the authority of the Vice-President, Research. The current procedures for consideration of Biosafety Permit application for the use of biohazardous materials are attached to this policy.
9. The Biosafety Officer shall undertake continuing education and training opportunities in biocontainment and security of biohazardous materials.

3. SFU Biosafety Committee membership

The SFU Biosafety Committee members will be appointed by the Vice-President, Research for renewable terms of three to four years. The committee membership should include:

1. five faculty members drawn from key units where faculty members hold biosafety permits. Expertise of the faculty must encompass microbiology, plant or animal pathogens, recombinant DNA, and containment principles;
2. the Director of the Animal Resource Centre;
3. one member representing laboratory technical staff;
4. two members representing community interests and concerns, with appropriate expertise in biosafety, and who have no affiliation with the University.
5. the Biosafety Officer;
6. a graduate student representative;
7. the Director of Environmental Health and Safety as non-voting resource member;
8. the SFU Biosafety committee must have a Vice Chair who can become designated Chair as required; and
9. a quorum of two thirds of the members should be established for the SFU Biosafety Committee meetings.

4. Standard Operating Procedures (SOPs)

SOPs and other guidelines for compliance inspections, acquisition, use, storage, and disposal of biohazardous materials are developed and published by the Biosafety Officer after having been approved by the SFU Biosafety Committee.

6. Interpretation

Questions of interpretation or application of this policy or its procedures shall be referred to the VP Research, whose decision shall be final.

PROCEDURES
Consideration of Application to Use Biohazardous Materials

The Principal Investigator (PI) submits a completed form entitled “Application for a Biosafety Permit for Research or Teaching” to the Biosafety Officer at least eight weeks before the planned commencement of the project. In certain cases, such as teaching protocols, the Biosafety Officer may agree to a different time scale. In all cases sufficient time must be allowed for the review of the procedures to be employed in the project. It is recommended that the application be reviewed by the Biosafety Officer prior to submission to the SFU Biosafety Committee. The application form is available from the Biosafety Officer or from the EHS, and SFU Research Services web site. The PI must review their research permit applications annually and renew their permits every four years.  In the case of teaching protocols, permits must be renewed every semester. Any changes to the application must be submitted as an amendment and approved before implementation. Major changes may warrant submission of a new application.

1. As part of the application, the PIs assign the risk group for each organism they propose to work with. Information on risk groups can be obtained by contacting the Biosafety Officer or Safety Advisors in Environmental Health and Safety.

    

2. Upon receipt by the Biosafety Officer, she/he reviews the application for consistency with the SFU Biosafety Committee Terms of Reference, assigns a permit number and considers the following:

1. the determination of whether the proposed handling of biohazardous materials conforms to the standards specified in this Policy; and
2. the availability of required containment facilities and containment equipment.

3. For CL 1 and 2 projects:

1. After review by the Biosafety Officer, the application is forwarded to the Chair of the SFU Biosafety Committee for review and decision. If a decision cannot be made, the permit application is forwarded to the SFU Biosafety Committee for the final decision.
2. The SFU Biosafety Committee is informed of all decisions made by the Chair at the next SFU Biosafety Committee meeting.

4. For CL 3 projects and for projects described under section c(i) above that were not approved by the Chair:

1. After a review is made by the Biosafety Officer, the application is sent to all SFU Biosafety Committee members for review. A decision by majority vote is made by the SFU Biosafety Committee at their next committee meeting. The Chair does not normally vote except to create or break a tie.
2. For all CL 3 projects, or any protocols of concern to the SFU Biosafety Committee, a presentation by the PI is required at the SFU Biosafety Committee meeting at which the application is considered.

5. For Biosafety Permit renewals:

1. The application is forwarded to the Biosafety Officer and if necessary to the Biosafety Committee Chair.
2. The SFU Biosafety Committee is informed of all renewals made by the Biosafety Officer or Chair at the next SFU Biosafety Committee meeting.

6. The Chair of the SFU Biosafety Committee informs the PI of the SFU Biosafety Committee decision in writing.
   
7. If the project is approved, the Biosafety Permit information will be made available to the Office of Research Services. The Environmental Health and Safety Department retains signed copies of all approved applications and permits.
   
8. If the project is not approved, the PI is asked for more information, and may be required to submit a revised project proposal for review by members of the SFU Biosafety Committee.
   
9. If these actions fail to lead to approval of the project, the Chair of the SFU Biosafety Committee provides the PI with a written statement of reason for non-approval of the project.
   
10. The PI may ask for a hearing before the SFU Biosafety Committee to appeal the decision. In the event the appeal is not successful, the PI may appeal to the Vice President, Research who may appoint an appeal committee. The decision of that committee, if ratified by the Vice President, Research, would be final. Health Canada may be called upon for information purposes; however, appeals cannot be directed to Health Canada.

BIOSAFETY COMMITTEE TERMS OF REFERENCE

The Simon Fraser University Biosafety Committee is authorized to oversee the University’s Biosafety Program, provide policy direction and recommend changes to the Vice President, Research for all teaching, research and testing activities involving the use of biohazardous materials. The Committee reviews biosafety permit applications for teaching, research and testing, issues permits, and monitors activities involving the use of biohazardous materials to confirm compliance with the standards outlined in the Biosafety Policy R20.02. These standards include Public Health Agency of Canada (PHAC), Canadian Food Inspection Agency (CFIA) National Institutes of Health (NIH), Occupational Health and Safety Regulation of BC (WCB), SFU Policies and SFU Biosafety Committee (SFUBC) Procedures.

Mandate
Administrative:

• Issues and renews Biosafety Permits for the use of all biohazardous materials and specifies appropriate procedural and physical laboratory containment requirements, and as required, implementation of health surveillance program;
• Reviews and, as required, amends containment level one, two and three permits issued by the Biosafety Committee Chair;
• Reviews and, as required, amends permit renewals issued by the Biosafety Officer;
• Advises the Vice President, Research of any perceived need for additional resources to establish, maintain, or improve the Biosafety Program.

 

Compliance & Conformance:

• Suspends Biosafety Permits in cases of non-compliance or in cases of emergencies involving loss or potential loss of containment;
• Monitors certification and re-certification of containment level 3 laboratories;
• Monitors movement of biohazardous materials within the University and for compliance with Transportation of Dangerous Goods Regulations when shipping or receiving biohazardous materials;
• Reviews summary results of external and internal inspections and recommends appropriate action;
• Reviews reports of incidents involving biohazardous materials and ensures appropriate action is taken to prevent reoccurrence.

 

Lab Containment & Security:

• Investigates and ensures remediation of containment failure;
• Ensures appropriate access control of containment level 2 and 3 laboratories and secure storage of potentially biohazardous materials.

 

Advisement:

• Advises on policies and protocols relating to the Biosafety Program to promote safe and environmentally appropriate practices, in support of compliance with regulatory and University requirements;
• On a three-year cycle, undertakes a formal review of the Biosafety Policy;
• Reviews research and teaching proposals involving the procurement, use, storage, transfer, and disposal of biohazardous materials to assess risk, containment requirements, proposed procedures, training and expertise of personnel;
• In consultation with the University Biosafety Officer, reviews, recommends and acts as an expert resource for biosafety education and training programs for University employees and researchers, and monitors training activity.

 

Reporting:

• Reports to the appropriate regulatory body substantial problems or violations of guidelines, and significant accidents or illnesses;
• Provides an annual report of its activities in the previous year and compliance status to the Vice President, Research each April.

Membership
All members are appointed by the Vice President, Research for a three-year renewable term. When deemed necessary for specific expertise, ad hoc consultants will be brought in.

The committee membership shall be as outlined in the Biosafety Policy R20.02:

• Five faculty drawn from key units where faculty members hold biosafety permits. Expertise of the committee must encompass microbiology, plant or animal pathogens, recombinant DNA, and containment principles;
• The Director of the Animal Resource Centre;
• One member representing laboratory technical staff;
• Two members representing community interests and concerns with appropriate expertise in biosafety, and who have no affiliation with the University;
• Biosafety Officer; and
• Graduate Student Representative.

 

Non- Voting resource members:

• Director of Environmental Health and Safety (EHS).

 

Chair
The chair shall be nominated and elected by the members for a three-year term.

The chair will also be responsible for encouraging all committee members to attend an orientation session, organized by the Biosafety Officer, on the duties of the committee and protocol of biosafety review.

Quorum
For voting purposes, two thirds of voting members must be present.

Voting Privileges
The Chair does not normally vote, except to create or break a tie. All other duly appointed members have voting privileges. Resource persons, as listed, are non-voting members of the committee.

Secretariat
EHS shall provide an individual to act as secretary. The secretary shall be responsible for:

• Recording minutes of the meetings and related correspondence;
• Issuing notices of meetings after consultation with the chair;
• Circulating meeting minutes to the members and Vice President Research; and
• Maintaining all biosafety committee documentation.

 

Meetings
The committee shall meet at least semesterly. To deal with any critical issues, the chair may call special meetings.

BIOSAFETY PROGRAM INSPECTION PROTOCOL

Regulations

Regulations pertaining to biohazard safety include 1) those from Canadian Federal Agencies, 2) those from agencies that provide funding, 3) WorkSafeBC, 4) transport regulations including vehicle, marine, and aircraft, 5) University requirements, and 6) codes of best practice.

PI (Principal Investigator) Inspection Responsibilities

• Completes the biosafety checklist each month and posts a copy. Although the PI may delegate responsibilities, the PI remains accountable for all activities occurring in his/her laboratory and common rooms.
• Reports significant problems, illnesses suspected of originating from biohazard work, incidents, or instances of non-compliance / non-conformance.
• PI may delegate inspection responsibilities to other lab personnel.
• The Biosafety Officer is available for consultation and guidance.

 

Simon Fraser University Biosafety Committee Responsibilities

• The Simon Fraser University Biosafety Committee (hereafter referred to as the committee) will investigate and report on incidents relating to biosafety brought to its attention whenever it is believed or suspected that any breach of compliance or conformance or other safety hazard may have occurred or is occurring.
• Committee members and Environmental Health and Safety employees who are trained in biosafety to the satisfaction of the committee may enter any containment level 1 or 2 laboratory or its related premises under the jurisdiction of SFU, at any time, to examine items related to biosafety operational procedures or physical containment. Inspection of containment level 3 facilities will be pre-arranged with laboratory personnel.
• The committee may decide to not grant a biosafety permit where previous indications of non-compliance / non-conformance either at SFU or other institutions indicates an unacceptable risk.
• The committee is responsible for conducting and/or delegating inspections.
• Inspections will be regularly conducted and of such frequency so as to provide an assurance to the University that all labs are reasonably believed to be in compliance and conformance at least once every year.

 

EHS Responsibilities

• Promote and monitor compliance with policies, regulations and procedures for safe use, handling, monitoring, storage, transport, and disposal of biohazardous materials.
• Advise the Vice-President, Research and the committee on matters related to non-compliance / non-conformance.
• Be available for consultation on problems.
• Ensure proper maintenance of records.
• Investigate reports of biosafety non-compliance / non-conformance in consultation with the committee.

 

1st Formal Inspection

• Inspections will identify items requiring attention and a written list of these items will be made available to the PI.
• Items that were rectified during the inspection will be noted.
• Items that cannot be rectified immediately will necessitate a 2nd inspection.

 

2nd Formal Inspection

Will be conducted to determine whether the items requiring rectification were addressed in a timely fashion. A summary of the inspection results will be made available to the PI and to the committee. The committee, upon reviewing the 2nd inspection results, may:

•  file a report in EHS and notify the PI that the laboratory or area is in compliance / conformance; or
• issue a notice to the PI requesting a written response to indicate either 1) how compliance / conformance will be attained and / or 2) why the PI believes the laboratory and personnel are in full compliance / conformance.

 

Review of Written Response

If the committee has requested a written response, the committee will review that response and:

• if the committee concurs that the laboratory or area is in compliance / conformance, the committee will so notify the PI and Environmental Health and Safety;
• if the committee believes that the written proposed actions will suitably address the non-compliance / non-conformance, the committee will so notify the PI, and schedule a 3rd inspection for verification; or
• if the committee believes that the laboratory or its personnel will remain in a state of non-compliance / non-conformance, the committee will engage in communication with the PI until such time as the committee deems that a 3rd inspection or alternate action (such as permit suspension) is appropriate. If the permit is suspended, the committee will notify the Vice President, Research and the granting agencies.

 

3rd Formal Inspection

Will be conducted under the conditions noted above. A summary of results will be made available to the PI and to the committee. The committee upon reviewing the 3rd inspection results may:

• file a report in EHS and notify the PI that the laboratory or area is in compliance / conformance; or
• if the committee believes that the laboratory or its personnel remain in a state of non-compliance / non-conformance, notify the PI and engage in communication with the PI until such time as the committee deems that alternate action is appropriate.

 

Consultation Outcome

• file a report in EHS and notify the PI that the laboratory or area is in compliance / conformance; or
• notify the Vice President, Research, the PI and granting agencies that the permit is suspended.

 

SFU Permit Suspension
If the committee has deemed it necessary to suspend an SFU biosafety permit, the committee will request records of non-compliance / non-conformance be held on a PI’s record for four years.

Immediate Dangers
If an immediate danger to people or the environment is observed, the committee may immediately suspend the SFU biosafety permit for that work and require the cessation of that work. The committee will notify the Vice President, Research and Environmental Health and Safety of the suspension.

Interpretation
Questions of interpretation or application of inspection procedures shall be referred to the committee.

Appeals
Decisions of the committee may be appealed to the Vice President, Research.