Governing Documents: Staff
PROCEDURES:
BIOLOGICAL SAFETY
Effective Date:
May 16, 2011
Revised Date:
September 9, 2012
Review Date:
September 9, 2022
Approving Body:
Administration: President
Authority:
Biological Safety Policy
Implementation:
President delegated to Vice-President (Research and International) and Vice-President (Administration), jointly
Contact:
Associate Vice-President (Human Resources)
Applies to:
All Employees; All Students; External Parties: All Contractors


1.0 Reason for Procedures

To set out Procedures secondary to the Policy entitled "Biological Safety", in connection with the Biological Safety Program for all biological materials, agents and other sources of biological hazards used for education and research at the University of Manitoba.

For purposes of these Procedures:

Biological hazards or biologically hazardous shall refer to any hazard which originates with the use of viruses, bacteria, fungi, recombinant DNA molecules, cells or tissue cultures or any other potentially infectious material at the University of Manitoba; and

Biological Workers refers to any staff or student who works with biological hazards.


2.0 Procedures

2.1 Biological Safety Advisory Committee

The Biological Safety Advisory Committee is authorized to:

(a) advise on the safe use of biological materials, agents and other sources of biological hazards, and prescribed equipment such as biosafety cabinets, autoclaves and the like;

(b) make recommendations on University Policies and Procedures related to biological materials, agents and other sources of biological hazards;

(c) approve standard operating procedures and guidelines;

(d) issue Biosafety Project Approval Certificates (from hereon will be referred to as “Certificate”) to control the use of all biological materials;

(e) revoke Certificates from individuals who contravene these Procedures or the Policy on Biological Safety.

2.1.1 Membership

(a) The Biological Safety Advisory Committee shall be composed of persons knowledgeable in the use of biologically hazardous materials. The total number of Committee members shall not be less than five (5) nor more than fourteen (14).

(b) The members shall be appointed by the Associate Vice-President (Research) and shall serve a three (3) year term. Re-appointments are permitted for an additional three (3) year term.

(c) Alternates are permitted during extended leaves of Committee members.

(d) The Director and designated staff of the Environmental Health and Safety Office shall be represented as ex-officio, non-voting member(s) of the Committee.

(e) The Associate Vice-President (Research) may appoint an ex-officio, non-voting member to the Committee.

2.1.2 Chairperson

(a) The Chair shall be appointed by and report to the Associate Vice-President (Research).

(b) The Chair is free to participate to an equal extent as any other member in the discussions and decisions of the meeting.

(c) The members of the Committee shall choose one (1) of their members to act as Vice-Chair in the event of the Chair’s absence.

2.1.3 Secretary

(a) The Environmental Health and Safety Office will provide administrative support to the Committee.

(b) The Environmental Health and Safety Office will be responsible for recording minutes of meetings, for correspondence arising from meetings, and for issuing notices of meetings after consultation with the Chair.

(c) The Environmental Health and Safety Office will be responsible for maintaining a file of minutes of Committee meetings and ensuring that:

(i) one (1) copy is sent to each member;

(ii) one (1) copy is filed with the Environmental Health and Safety Office;

(iii) one (1) copy is sent to the Associate Vice-President (Human Resources);

(iv) one (1) copy is sent to the Vice-President (Administration);

(v) one (1) copy is sent to the Vice-President (Research and International);

(vi) one (1) copy is sent to the Vice-President (Academic);

(vii) one (1) copy is sent to the Office of Research Services.

(d) The Environmental Health and Safety Office shall maintain a file of all correspondence to and from the Committee.

2.1.4 Meetings

(a) The Committee shall schedule meetings in at least ten (10) months of the year.

(b) The date of the next regular meeting shall be determined at each meeting.

(c) Special meetings may be called by the Chair, or the Vice-Chair, for the purposes of considering causes of accidents or dangerous occurrences, contaminating incidents, conditions dangerous to health or safety, permit applications and revocations, or circumstances requiring immediate consideration.

(d) The quorum for Committee meetings shall consist of one-half (1/2) of the members.

2.1.5 Duties

(a) The Committee shall recommend to the Associate Vice-President (Human Resources) practical procedures and guidelines which will help achieve the highest possible degree of safety in the use of biologically hazardous materials.

(b) The Committee shall ensure a system is in place for the identification, recording, examination, evaluation and resolution of health and safety concerns, arising through use of biologically hazardous materials. The Committee shall periodically review this system and recommend any changes as appropriate in its view.

(c) The Committee, with support from the EHSO, shall advise and promote on the development of education and training programs on a University-wide basis, designed to provide each person handling biologically hazardous material with a detailed knowledge of hazards and protection therefrom, consistent with the individual requirements and current guidelines and regulatory requirements.

(d) The Committee, with support from the EHSO, shall ensure that a listing of biologically hazardous materials within the University and the locations and faculties where they are used and stored is maintained. A current list of all Biosafety Permits (from hereon will be referred to as “Permit”) required for use or possession shall be maintained.

(e) The Committee shall be responsible for ensuring a system is in place for the issuing or cancellation of all Permits required for the use of biologically hazardous materials. The Committee shall periodically review this system and recommend any changes as appropriate in its view.

(f) The Committee shall establish a procedure and undertake a review process for Project Approval Certificate applications, and will assess the risk level per appropriate Guidelines and will make recommendations as to operating protocol, immunization, and safety equipment required for the project applied for. Certificates may be reviewed periodically and may be altered or cancelled by the Committee. The Committee may identify expert advisors to assist with the review process.

(g) The Committee shall maintain a liaison with the University of Manitoba’s Organizational Safety and Health Advisory (OSHA) committee to consider problems of joint interest.

(h) The Committee, with support from the EHSO, shall be responsible for ensuring a system is in place to investigate any loss, theft or incident within the University which, in their view, could present a significant biological hazard to University personnel or the general public or have resulted in an injury or indication of ill health.

(i) At the end of each academic year, an annual report shall be prepared with a summary of the year's activities and an indication of compliance with University of Manitoba and Health Canada Laboratory Biosafety Guidelines. The Report shall be submitted to the Vice-President (Administration) and to the Vice-President (Research and International).

2.2 Biological Safety Officer

(a) The Environmental Health and Safety Office is responsible for the provision of appointing a Biological Safety Officer and additional designates as deemed necessary. The Biological Safety Officer, and designates, implement the Biological Safety Program, acting in consultation with the Biological Safety Advisory Committee. There shall be at least one (1) individual at all times designated to fulfill the duties of the Biological Safety Officer.

(b) The Biological Safety Officer will sign off on all completed permit applications.

2.3 Permit Holder

The Permit Holder is responsible to:

(a) ensure that all Biological Workers as listed on their Permit are aware of all biological safety procedures;

(b) ensure that all Biological Workers are trained to work safely with biological materials, agents and other sources of biological hazards and to provide site-specific training in the safe use of biological materials, agents and other sources of biological hazards;

(c) regularly assess and inspect their areas for compliance with biological safety procedures;

(d) ensure that any incidents that occur in their area are promptly reported to the Environmental Health and Safety Office and investigated in accordance with University reporting requirements; and

(e) adhere to all duties and responsibilities as listed on the Permit.

2.4 WHMIS Coordinators

As part of their general duties and responsibilities, Departmental WHMIS Coordinators will have duties and responsibilities under these Procedures related specifically to biological safety.

Those duties will include performing verification of safety equipment certification, completeness and accuracy, including signatory, of permit questionnaires and training records.

2.5 Biological Workers

Personnel, including staff and students, listed on a Permit shall adhere to all responsibilities as listed in the Biosafety Guide and follow all applicable Federal, Provincial and University policies, procedures and guidelines.

2.6 Biosafety Guide

The Environmental Health and Safety Office shall develop and maintain a University Biosafety Guide containing the elements of a comprehensive Biosafety Program. The Biological Safety Advisory Committee shall review, approve and enforce the protocols identified in the Guideline.

2.7 Release of Research Funds

The Office of Research Services will not release research funds to any person working with Risk Group 1-4 biological agents without an approved Permit and Certificate as described in sections 2.8 and 2.9.

2.8 Permit

2.8.1 Biological Safety Officer to Issue Permit

The Biological Safety Officer shall issue a Permit.

The Permit will specify:

(a) the name of the Permit Holder;

(b) the term period of the Permit;

(c) the names of the Biological Workers;

(d) permitted Biological material or devices and possession limits;

(e) approved locations;

(f) required and approved safety equipment;

(g) an approved disposal procedure; and

(h) any other conditions prescribed by the Committee.

2.8.2 No Person to Undertake Work

No person shall undertake work with Risk Group 1-4 biological materials, agents and other sources of biological hazards unless in possession of a valid Permit and Certificate. The Permit is conditional on the strict adherence to all conditions and parameters listed on the Permit. The person whom the Permit is assigned to is the Responsible User/Permit Holder. 

2.8.3 Eligibility

In order to be eligible to work with biological materials, agents and other sources of biological hazards, one must be:

(a) an appropriately trained Principal Investigator supervised by a Vice-President, Dean, Director or Department Head;

(b) a Biological Worker is a person working under the supervision of the Permit Holder and listed on the Permit);

(c) Heads of Clinical Units.

2.8.4 Permit Holder in Compliance

The Permit Holder shall ensure that there is full compliance with all the conditions specified on the Permit and Certificate and that Biological Workers are oriented and trained on the hazards of working with biological materials, agents and other sources of biological hazards and the safe working procedures.

2.8.5 Application for Permit

A Principal Investigator shall complete an Application for a Biosafety Permit (available on the VPRI web site) and submit it to the Environmental Health and Safety Office. The Biological Safety Officer shall assess the application, evaluate the permit application with respect to the new permit applications checklist requirements, will conduct random audits and may inspect for permit amendments. Once the Biological Safety Officer is satisfied with the Permit information and documentation, it shall be signed by the Biological Safety Officer.

2.9 Certificate

2.9.1 Biological Safety Advisory Committee Chair to Issue Certificate

The Chair of the Biological Safety Advisory Committee shall issue a Certificate to control the conditions of use, storage, transport and disposal used in educational, research and clinical areas.

The Certificate will specify:

(a) Risk assessment;

(b) Safe work practices;

(c) a detailed description of project procedures reviewed for compliance.

2.9.2 No Person to Undertake Work

No person shall undertake work with biological materials, agents and other sources of biological hazards unless in possession of a valid Certificate. The Certificate is conditional on the strict adherence to all conditions and parameters listed on the Certificate. The person, to whom the Certificate is assigned, is the Responsible User/Permit Holder. 

2.9.3 Eligibility

In order to be eligible to hold a Certificate, one must be:

(a) an appropriately-trained Principal Investigator supervised by a Vice-President, Dean, Director , Department Head, or Clinical Head; and

(b) hold a Permit issued by an approved institution.

2.9.4 Certificate Holder in Compliance

The Certificate Holder shall ensure that there is full compliance with all the conditions specified on the Certificate and that Biological Workers are oriented and trained on the hazards of working with biological materials, agents and other sources of biological hazards and the safe working procedures.

2.9.5 Application for Certificate

A Principal Investigator shall complete an application (available on the VPRI web site) for a Biosafety Project Approval Certificate and submit it to the Environmental Health and Safety Office. The Biological Safety Advisory Committee shall assess the application, evaluate the risk safe work practices and a detailed description of the project procedures. Once the Biological Safety Advisory Committee is satisfied, the Chair shall sign the approval and the Certificate will be issued.

2.10 Training

All Permit Holders and Biological Workers shall be trained in accordance with recognized Biological Safety Procedures and protocols outlined in the University Biosafety Program Guideline. All Biological Workers shall receive site specific biosafety training which focuses on the biological agents and techniques used in the permitted lab in which they work.

2.11 Notification of Changes to Research

Researchers with a Certificate must report amendments to the BSAC. A project amendment must be filed with the BSAC when there are changes in the biological agents used or significant changes in procedures or process. Failure to report these changes may result in suspension of the Certificate at which point operations will be suspended.

2.12 Reports and Audits

2.12.1 The Environmental Health and Safety Office shall make periodic audits of all permitted activities. Inspections of facilities may be announced or unannounced. All Permit Holders and Biological Workers are required to cooperate with EHSO personnel. The Biological Safety Officer or designate, or BSAC representative may require periodic written reports from the Permit/Certificate Holder with respect to internal compliance activities, operating procedures, and training activities .

2.13 Enforcement

2.13.1 On the first occurrence of non-compliance related to any terms and conditions of the Permit, the Permit Holder shall be notified in writing by the Biological Safety Officer or designate with reference to the contravention of Biological Safety Procedures. The Permit Holder will be expected to come into compliance as directed by the Biological Safety Officer. Failure to correct within a reasonable period of time as specified by the Biological Safety Officer or designate will constitute a second offence.

2.13.2 On the second occurrence within a twelve (12) month period of non-compliance, the Biological Safety Officer will send a letter as a "Notice of Non-Compliance" to the Permit/Certificate Holder that:

(a) is copied to the direct supervisor of the Permit/Certificate Holder;

(b) has reference to the non-compliance of Biological Safety Procedures, the duties of the Permit/Certificate Holder in that respect, and the consequences of further infractions; and

(c) will be communicated to all members of the Biological Safety Advisory Committee and the Office of Research Services.

2.13.3

2.13.3.1 On the third occurrence within a twelve (12) month period of non-compliance. The Permit/Certificate Holder will be suspended until full resolution of compliance. The Biological Safety Officer shall inform the Chair of the Biological Safety Advisory Committee and the Office of Research Services. 

2.13.3.2 The Chair shall call an emergency ad hoc meeting of the Biological Safety Advisory Committee to be held within seven (7) days. The Chair will invite the direct supervisor and the Permit/Certificate Holder. The Office of Research Services will also be advised of the meeting. At this meeting, the Permit/Certificate Holder and his/her direct supervisor, as well as the Chair of the pertinent peer review committee and the auditor(s) will be required to show cause as to why/why not the Permit should be reinstated. 

2.13.3.3 If a majority of the membership of the Biological Safety Advisory Committee members in attendance is not satisfied that the Permit/Certificate Holder has provided justification for retaining the Permit/Certificate, the Permit/Certificate shall be revoked and the Biological Safety Advisory Committee may arrange for the redistribution of all biological materials. 

2.13.3.4 The Chair of the Biological Safety Advisory Committee will notify the Dean of the appropriate Faculty, the Associate Vice-President (Human Resources), and the Office of Research Services of the Committee’s decision. 

2.13.4 Notwithstanding any of the above actions, if it is the opinion of the Biological Safety Officer or designate that a serious, immediate risk to health, safety, environment or security exists, the Biological Safety Officer or designate shall have the authority to immediately suspend operations or temporarily suspend a Permit. The Biological Safety Officer or designate shall report on the situation, and the steps taken, to the Chair of the Biological Safety Advisory Committee. The Chair of the Biological Safety Advisory Committee will proceed as though this incident was a third occurrence within a year.

2.13.5 A permit holder may appeal a decision to deny, alter or revoke a permit. The appeal will be referred to the Vice-President (Administration) and/or or his/her designate who will investigate the matter and render a final and binding decision.

3.0 Accountability

3.1 University Secretary is responsible for advising the President that a formal review of these Procedures and Secondary Documents are required.

3.2 The Associate Vice-President (Human Resources) is responsible for the communication, administration and interpretation of these Procedures.

3.3 The Director of the Environmental Health and Safety Office is responsible for the Biological Safety Program and support to the Biological Safety Advisory Committee.

3.4 All employees and students are accountable for complying with the applicable Federal, Provincial and University policies, procedures and guidelines.


4.0
Review

4.1 Formal Procedure reviews will be conducted every ten (10) years. The next scheduled review date for these Procedures is September 9, 2022.

4.2 In the interim, these Procedures may be revised or rescinded if:

(a) the Vice-President (Administration), the Vice-President (Research and International) or the President deems necessary; or

(b) the relevant Policy is revised or rescinded.


5.0 Effect on Previous Statements

5.1 These Procedures supersede the Biological Safety Procedures (dated May 16, 2011).


6.0 Cross References

Biological Safety Policy
Health and Safety Policy