Page 1
Page 2
Page 3
Page 4
Page 5
Page 6
Page 7
Page 8
Page 9
Page 10
Page 11
Page 12
Page 13
Page 14

S.06-69

Simon Fraser University

Memorandum

To: ?

Senate

From: ?

Alison Watt, Secretary

Senate Committee on Agenda and Rules

Date: ?

May 3, 2006

Subject: ?

Policy Revision: R20.02 - Biosafety Policy

At its meeting on May 2, 2006, SCAR recommended that the revisions to Policy R20.02 -

Biosafety Policy be placed on the Senate agenda for information.

J^ ( ' sc. 

Oag

j74

v=r

Biosafety Policy R20.02

1. Purpose

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.

Definitions

Biological Materials

"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;

"Human materials" are defined as human blood, blood products, blood

components, body fluids, tissues or organs;

"Animal materials" are defined as animal blood, blood products, blood

components, body fluids, tissue or organs;

"Plant materials" are defined as plant pathogens, transgenic plants, plant

toxins and exotic plants;

"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.

"CU." applies to a basic microbiology laboratory, where work may be

done on an open bench top;

"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

OH&S ?

March 2, 2006 ?

1/8

of biosafety cabinets, sealed rotor centrifuges as well as appropriate

personal protective equipment;

"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

"PHAC" Public Health Agency of Canada;

"CFIA" Canadian Food Inspection Agency;

k. "NIH" National Institutes of Health;

I. "TDG" Transportation of Dangerous Goods

"WCB" Workers Compensation Board, Occupational Health and Safety

Regulation;

n. "GVRD" Greater Vancouver Regional District.

Administrative Requirement

o. "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

"Principal Investigator (P1)" is defined as the SFU faculty member (or

acceptable equivalent as defined in other SFU policies) in charge of a

research or teaching project;

"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;

r. "Certified User" is defined as the individual whose name appears on the

approved Biosafety Permit;

"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.

3. Scope

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

OH&S ?

March 2, 2006

2/8

(or equivalent as defined in 2p above) as P1. 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.

4. Standards

The University adopts standards compliant with:

the Memorandum of Understanding between the three Canadian federal

granting agencies and Institutions that receive their awards;

the policies and procedures of SFU and the SFU Biosafety Committee;

all relevant federal and provincial regulations (Public Health Agency of

Canada, Canadian Food Inspection Agency);

the National Institutes of Health;

the Workers' Compensation Board; and

Transportation of Dangerous Goods.

5. Policy

Authority

The SFU Biosafety Committee has the authority, on behalf of the Vice-

President, Research, to:

I. 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.

Responsibility

L 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 P1.

ii.

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.

iii.

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.

iv.

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 GVRD regulations and

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 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.

vi.

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.

vii.

The SFU Biosafety Committee ensures that researchers use

appropriate containment facilities for the proposed research involving

biohazardous materials.

viii.

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.

ix. The Biosafety Officer shall undertake continuing education and training

opportunities in biocontainment and security of biohazardous

materials.

c. 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:

L 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;

the Director of the Animal Care Facility;

iii.

one member representing laboratory technical staff;

iv.

two members representing community interests and concerns, with

appropriate expertise in biosafety, and who have no affiliation with

the University.

the Biosafety Officer;

vi.

a graduate student representative;

vii.

the Manager of Occupational Health and Safety as non-voting resource

member;

viii.

the SFU Biosafety committee must have a Vice Chair who can become

designated Chair as required; and

ix.

a quorum of two thirds of the members should be established for the

SFU Biosafety Committee meetings.

d. 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.

Simon Fraser University Biosafety Committee

Procedures

Consideration of Application to Use Biohazardous Materials

The Principal Investigator (P1) 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 (604-291-5728) or from the

OH&S, and SFU Research Policies web site. The P1 must renew their research

applications annually and in the case of teaching protocols, they 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.

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 Occupational

Health and Safety.

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:

L the determination of whether the proposed handling of biohazardous

materials conforms to the standards specified in this Policy; and

ii. the availability of required containment facilities and containment

equipment.

For CL 1 and 2 projects:

L 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.

ii. The SFU Biosafety Committee is informed of all decisions made by the

Chair at the next SFU Biosafety Committee meeting.

For CL 3 projects and for projects described under section c(i) above that

were not approved by the Chair:

L 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.

ii. For all CL 3 projects, or any protocols of concern to the SFU Biosafety

Committee, a presentation by the P1 is required at the SFU Biosafety

Committee meeting at which the application is considered.

For Biosafety Permit renewals:

i. The application is forwarded to the Biosafety Officer and if necessary

to the Biosafety Committee Chair.

ii. The SFU Biosafety Committee is informed of all renewals made by the

Biosafety Officer or Chair at the next SFU Biosafety Committee

meeting.

The Chair of the SFU Biosafety Committee informs the P1 of the SFU

Biosafety Committee decision in writing.

If the project is approved, the Biosafety Permit information will be made

available to the Office of Research Services. The Occupational Health and

Safety Office retain signed copies of all approved applications and

permits.

If the project is not approved, the P1 is asked for more information, and

may be required to submit a revised project proposal for review by

members of the SFU Biosafety Committee.

If these actions fail to lead to approval of the project, the Chair of the SFU

Biosafety Committee provides the P1 with a written statement of reason

for non-approval of the project.

The P1 may ask for a hearing before the SFU Biosafety Committee to

appeal the decision. In the event the appeal is not successful, the P1 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

Biosafety Committee (R20.02)

Policies and

Procedures

Policy Gazette

Draft Policies

Archived Policies

AVP, Legal Affairs

Date

September 23, 1999

Revision Date

EXISTING POLICY

Search SFU.ca

Number

R 20.02

Revision No.

Biosafety Committee (R20.02)

SIMON FRASER UNIVERSITY

Policies and Procedures

Biosafety Committee

Purpose

Simon Fraser University is committed to providing a safe work environment. The Biosafety

Committee will review and approve all potentially biohazardous research or teaching prior to the

work being undertaken. All work shall comply with all relevant standards including Health

Canada's Laboratory Biosafety Guidelines, Agriculture Canada's Containment Standards for

Veterinary Facilities, and University procedures.

The Biosafety Committee will monitor research grant applications, facility design, and

containment procedures and equipment. Teaching labs using biohazardous materials will be

assessed by the same criteria as research labs.

Definition of Biohazards

Biohazards are defined as biological agents and materials which 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; and primate body fluids. Also included are potentially biohazardous organisms

used in procedures such as recombinant DNA and genetic manipulations. Biohazards will be

classified according to risk levels requiring appropriate containment.

Applicability

This policy applies to all personnel at Simon Fraser University associated with biohazardous

research and teaching, and students working in research and teaching laboratories involving

biohazards.

Scope

The University acknowledges its responsibility to provide a program for the handling, storage

and disposal of biohazardous waste material as well as a capacity to provide emergency

response to biohazardous incidents, through the Biosafety Program. It also affirms the

responsibility of the researcher to comply with the applicable guidelines. These guidelines have

been adopted by many research granting agencies as a condition of issuing a research grant. A

Biosafety Certificate is required to certify that the grant requester is aware of the hazards

involved, is familiar with the applicable guidelines, develops safe work procedures and ensures

anyone who may come in contact with the biohazard is appropriately trained.

http://www.sfu.ca/policies/research/r20-02.htm ?

- ?

Page I of 5

Biosafety Committee (R20.02)

4/27/06 2:04 PM

S. Responsibility of the Occupational Health and Safety Office (O.H.&S.)

Publicizes guidelines, monitors adherence to guidelines and reports problems or infraction

to the Chair of the Biosafety Committee.

Investigates reported accidents or spills of biohazardous material and reports to the chair of

the Biosafety Committee if a perceived hazard persists. Ensures appropriate corrective

measures are implemented.

Arranges for appropriate testing of Biosafety equipment.

Coordinates general biosafety training.

S. Processes applications for Biohazardous/ Recombinant DNA Research for the approval of the

Biosafety Committee.

6. Maintains records of certification for all certified users of biohazardous material.

6. Responsibilities of Principal Investigator

1. Ensures compliance with all relevant standards and guidelines including the Simon Fraser

University Biosafety Policies and Procedures.

2. Initiates a review and seeks approval of research/teaching program by the Biosafety

Committee. The process involves filling in the form

"Application for Approval of

Biohazardous/Recombinant DNA/RNA Research or Teaching Facilities."

This form

must be completed to reflect the full range of projects contained in the research/teaching

program . If necessary make duplicates of applicable pages where more than one project

must be described.

3. Develops a detailed protocol of specific work procedures for handling biohazardous

materials.

Ensures that researchers, students and employees for which he/she is responsible have

been given adequate direction, training, and instruction in the safe performance of their

work.

S. Limits the use of biohazardous material to the certified facilities.

Develops appropriate emergency and decontamination procedures for his/her area of work.

7. Ensures reports of potentially hazardous incidents and accidents are prepared and

forwarded to the Biosafety Committee Chair with copy to the O.H.&S. Office.

7. Responsibilities of Certified User

Familiarity with SFU Biosafety Policy and Procedures.

2. Follows specified work procedures

ltttp://www.sfu.ca/policieslresearch/r20-02.htm ?

0 .

Page 2 of

Biosafety Committee (R20.02)

4127/06

2:04 PM

3. Uses the appropriate protective equipment.

Reports to the Principal Investigator any incidents or accidents involving the use of

biohazardous materials.

S. Biosafety Committee Terms of Reference

Advise the Vice-President, Research on matters related to biohazards and biosafety.

Develop, recommend and implement policies and procedures for the safe use of

biohazardous materials in accordance with the current Medical Research Council guidelines

and other pertinent regulatory agencies.

Review all research and teaching proposals involving biohazardous materials. When

deemed necessary, approve containment requirements, inspect facilities and review work

procedures to ensure compliance with regulatory agencies.

Issue certification for use of biohazardous material and stipulate the conditions of use to

ensure compliance with current guidelines and other pertinent guidelines or regulations.

Review certification periodically.

S. Ensure proper procedures are in place for acquisition, storage, use, disposal, and transport

of biohazardous materials.

Advise the University Occupational Health and Safety Office on matters regarding biosafety,

and arrange for dissemination of information pertinent to the use of biohazardous material.

Maintain in the Occupational Health and Safety Office records associated with use of

potentially biohazardous material.

Investigate reports of user infractions of procedures and relevant guidelines and

recommend corrective action.

Biosafety Committee Membership

The committee membership is to be drawn from those departments engaged in research

considered biohazardous and be chaired by a senior committee member. The Manager of

Occupational Health and Safety shall also be a member. The committee is to meet as needed,

and report to the Vice-President, Research.

The Committee will also include the following

ex officio

members:

Consultants as required

Director, Research Services

Occupational Health and Safety Officer

Medical Team Leader, Health Services

Procedures for Approval to Work with Biohazardous materials

1. Application To Use Biohazardous Materials

hup://www.sfu.ca/policies/research/r20-02.htm ?

1/ -

Page 3 of

Biosafeiy Committee (R20.02) ?

4127/06

2:04 PM

Click here for the Biosafety Permit Application for use of biohazardous materials. The form is

also available from the Occupational Health and Safety (OH&S) Office, and from the Chair of the

Biosafety Committee. Once the form is completed, it is signed by the principal investigator an

forwarded to the Chair of the Biosafety Committee for assessment and signature. The Chair

forwards the signed application to OH&S where an Approval number is assigned. OH&S retains

the original application and forwards to the principal investigator a copy of the cover page with

both signatures and a cover letter explaining responsibilities of the permit. Research Services

also receives a copy of the cover page as required to release funds from granting agencies.

Approval will be granted for a program and the associated facility. Approval for use of

biohazardous material will only be issued to faculty members. Biohazardous material may not be

used for any purpose or in any other location, other than that originally approved by the

Biosafety Committee. Project changes will require an amendment to the application.

Amendments to Approved Applications

Should a new project be initiated, enquiries should be directed to OH&S to determine if an

amendment to the application is necessary. If necessary, amendment requests must be received

in writing at OH&S who will arrange for Biosafety Committee review. Personnel changes are to

be reported to OH&S as they occur. Once a year OH&S will generate a list of certified personnel

and request that the principal investigator verify it is current.

3. Renewal of Previously Approved Applications

Approval to work with biohazardous material is for a maximum period of four years. Two months

prior to expiry, OH&S will issue a reminder of the expiry date. At that time, the principal

investigator must specify whether the program is to continue and whether any changes are

planned. Major changes to an application will require referral to the Biosafety Committee.

Certification of Granting Agency Forms

All granting agency biosafety forms are to be completed by the applicant and forwarded to

Research Services. Research Services will ensure that biosafety forms for granting agencies ar

signed by a member of the Biosafety Committee (or a Biosafety Committee member other than

the applicant).

S. Facilities and Equipment Assessment

The facilities and equipment will be assessed as part of the research/course approval. The

assessment will be done by the O.H.&S. Office. Biosafety cabinets and all HEPA filtered

equipment must have a valid performance certificate attached on a conspicuous location to

verify current testing. Testing is required:

Prior to use

b. Annually thereafter

After relocation

d. After HEPA filter replacement

After servicing such as a fan motor replacement.

The Biosafety Committee will reserve the right to periodically repeat the assessment to verify

current status or implementation of guideline and regulation amendments.

6. Biohazard Signs

The sign shown in Appendix 1 should be posted for facilities approved for biohazardous work or

storage of Risk Groups 2, 3 or 4. The sign signifies the presence of a biohazard, identifies the

principal investigator, and displays emergency telephone numbers which are also registered with

Security for emergency purposes.

Orientation and Training

Principal investigators are responsible for being cognizant of all hazards associated with their

http://www.sfu.ca/policies/rcsearch/r20-O2.htin ?

I? ?

Page 4 of

Biosafety Committee (R20.02)

4/27/06 2:04 PM

research projects and for ensuring that personnel reporting to them are trained in safe

laboratory practices and understand the hazards. Training and understanding cannot be

• ?

assumed for employees or students transferring from another laboratory or institution.

8. Emergency Response

Emergency response procedures must be developed and posted for all facilities approved for

biohazardous work or storage of Risk Groups 2, 3, or 4. Every person using the containment

facility must be made aware of its contents. For practical purposes, procedures should be simple,

and a copy filed with OH&S.

Interpretation

Questions of interpretation or application of this policy or its procedures shall be referred to the

President, whose decision shall be final.

Appendix #1

Biohazard Sign

(for a copy of this sign, please contact the SFU Safety Office at 604.291.4978)

Terms & Conditions ?

MARQUi

http://www.sfu.caJpolicieslresearch/r20-02.htm ?

13.

Page 5 of 5