Plan for Administrative Oversight for Pathogens and Toxins in a Research Setting
Prepared on behalf of the University of Manitoba by Steven Cole (Institutional Biological Safety Officer)
November 16, 2015
This document has been prepared to support the University of Manitoba’s application to apply for a license to use pathogens under the Human Pathogens and Toxins Act / Regulations. It describes the University’s Biological Safety Program in the context of the ten required elements described in The Public Health Agency of Canada (The Agency) document entitled “Plan for Administrative Oversight for Pathogens and Toxins in a Research Setting- Required Elements and Guidance”. It is intended to document the University Biological Safety Program compliance with the required elements identified. This document is a high level overview and does not go into specific details of the program nor does it repeat elements described in the Canadian Biological Safety Standards.
Elements to be Covered Within the Plan
Element 1: Commitment from Senior Management to manage and control Biological Safety and biosecurity risks at the institution/organization.
Program Element 1: The University of Manitoba has a Biological Safety Policy and Procedure which can be accessed here: http://umanitoba.ca/admin/governance/governing_documents/staff/928.html and here: http://umanitoba.ca/admin/governance/governing_documents/staff/929.html . The Governing Documents of the University of Manitoba include all Policies, Bylaws, Regulations and Procedures approved by the Board of Governors, Senate and the University Administration.
Element 2: Delineation of the roles and responsibilities for committees, individuals, departments etc., that have a role in the control/management of Biological Safety and biosecurity risks.
Program Element 2: The University of Manitoba Biological Safety Policy and Procedure delineates the roles and responsibilities for committees and individuals that have a role in the control/management of Biological Safety and biosecurity risks. Refer to Policy section 2.1 The Biological Safety Advisory Committee, section 2.2 The Biological Safety Officer and section 3.0 Accountability. See also Procedure section 2.1 Biological Safety Advisory Committee, section 2.2 Biological Safety Officer, section 2.3 Permit Holder, section 2.4 WHMIS Coordinators, section 2.5 Biological Workers and section 3.0 Accountability.
Element 3: Establishment of a single point of contact to provide guidance on the Plan and a senior level ‘champion’ who can represent Biological Safety issues at a senior level on his/her behalf.
Program Element 3: The single point of contact is the Biological Safety Officer. The University of Manitoba employs a dual reporting structure for Biological Safety shared by both the Office of the Vice President (Administration) and the Office of the Vice President (Research and International).
Environmental Health and Safety reports to the Office of the Vice-President (Administration). The appointed Biological Safety Officer is Steven Cole (2010-present). The Biological Safety Officer reports to the University Environmental Health and Safety Coordinator (Leona Page July 2015-present) who reports to the University Environmental Health and Safety Director (Shannon Boychuk October 2015-present).
The Biological Safety Advisory Committee (Institutional Biological Safety Committee) reports to the Associate Vice-President (Research) Dr. Gary Glavin (2009-present) who reports to the Office of the Vice-President (Research and International). The Biological Safety Officer’s role as an ex-officio member of the Biological Safety Advisory Committee provides a link to the Associate Vice-President (Research) for matters pertaining to program implementation and registration / licensure with The Agency. The Associate Vice-President is the license holder identified in the Human Pathogens and Toxins Act license application.
Element 4: Overview of how Biological Safety and biosecurity risks, including those from research with dual-use potential, are identified at the institution/organization.
Program Element 4: Biological Safety and biosecurity risks are identified in a two part process.
In order to use biological agents at the University of Manitoba a Principal Investigator must hold a valid Biological Safety permit and Biological Workers must be listed on a permit (see Procedure sections 2.8.2 No Person to Undertake Work and 2.8.3 Eligibility). The Biological Safety permit system registers users and collects / documents information for the investigators inventory and overarching risk assessment. Permits are accepted, reviewed and approved by the Biological Safety Officer. In this part of the process the Biological Safety officer has the opportunity to review the general scope of work for the applicant as well as the biological agent inventory (held or proposed inventory) for risks including agents with possible dual use potential. Permits are valid for 5 years and must be updated within 30 days when key factors or personnel changes occur. The permit application process is described in greater detail here: http://umanitoba.ca/admin/vp_admin/risk_management/ehso/bio_safety/biopermits.html
A project based risk assessment is conducted using a Biological Safety Project Approval Certificate application which is submitted to the Biological Safety Advisory Committee for review. For work in locations controlled by the University an applicant must first hold a valid permit before they can qualify for a certificate. The certificate process collects / documents more detailed information regarding the specific agents and procedures in a proposed project. A Principal Investigator submits a Certificate application when they receive grant funding. Funds are released by the Office of Research Services only after the applicant provides an approval certificate to the Office of Research Services. In order to receive certificate approval the committee must be satisfied that the containment level and safety procedures identified are appropriate for the proposed work. The certificate is valid until the grant expires. The detailed review conducted by experts appointed to the committee for certificate approval is the most appropriate to identify dual use agents, knowledge, technology or intermediate and final products. The certificate application process is described in greater detail here: http://umanitoba.ca/admin/vp_admin/risk_management/ehso/bio_safety/4225.html
Element 5: Overview of how Biological Safety and biosecurity risks, including those from research with dual-use potential, are assessed once they have been identified at an institutional/ organizational level.
Program Element 5: Biological Safety and biosecurity risks are assessed both in the permit and certificate processes indicated above.
Element 6: Overview of how the Biological Safety and biosecurity risks, including those from research with dual-use potential, are managed and controlled at an institutional/organizational level.
Program Element 6: Biological Safety and biosecurity risks are controlled by the Principal Investigators according to recommendations made by the Biological Safety Officer during the permit application process and the Biological Safety Advisory Committee during the certificate application processes.
Element 7: Description of all work areas covered by the Plan (research areas, teaching, off-site etc.).
Program Element 7: All areas where work with biological agents risk group 1-3 are included in the University of Manitoba Biological Safety Policy and Procedure. Work in these areas must be conducted in permitted spaces and certificates must be supplied for the release of grant funds. Principal Investigators are responsible for establishing Biological Safety permits in their assigned spaces if they work with biological agents. They are required to renew their permits every 5 years or within 30 days of a change in the information provided as part of their permit application. Containment requirements are established by the Principal Investigator at the time of permit application by assessing the agents held or to be held in the inventory, the scope and scale of the work planned for the area. Initial applications will be reviewed and approved by the applicant’s department head. The submitted Biological Safety permit application is reviewed by the Biological Safety Officer to verify that the declared containment requirements are appropriate. When the Officer is satisfied final approval is granted.
Off-site facilities included in the license must have a contract with the University of Manitoba which specifically states what services will be provided and how.
Element 8: Description of all individuals covered by the Plan (researchers, faculty, students etc.).
Program Element 8: No person is to undertake work with biological agents at the University of Manitoba unless they are in possession of a valid Biological Safety permit or they are listed on a valid Biological Safety permit. All individuals including workers and supervisors who work with biological agents are covered by the program. Refer to procedure section 2.8.2 No Person to Undertake Work.
Element 9: Summary of how the Plan is communicated.
Program Element 9: The plan is communicated through generic Biological Safety training which is required for all persons covered under the plan. Principal Investigators are advised of changes and updates relevant to the plan through an e-mail list serve.
Element 10: Overview of the procedures to review and monitor the Plan.
Program Element 10: The University of Manitoba Biological Safety Policy and Procedure have mandatory 10 year review deadlines but can be updated earlier when there are changes to regulatory or administrative factors.
When new acts, regulations or standards are released the current program is reviewed and updated accordingly. The program may also be updated in response to feedback from the permit holders, institutional stakeholders, Biological Safety Advisory Committee or by the Biological Safety Officer when adjusting administrative efficiencies or correcting errors discovered in the course of program administration. Barring all those factors the program is reviewed every 5 years.
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