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) and Vanessa Pinto (Biological Safety Specialist/Alternate Institutional Biological Safety Officer)
This document has been updated to reflect the changes to the biosafety program at the University of Manitoba. 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’s Biological Safety Program compliance with the required elements identified. This document is an 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 Vice-President (Administration). The appointed Biological Safety Officer is Steven Cole (2010-present). The Biological Safety Officer reports to the Director of Risk Management (John Dodd February 2018-present) who reports to the University Chief Risk Management Officer (Alan Scott July 2017 – 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 Program Permit and Biological Workers must be listed on a program permit (see Procedure sections 2.8.2 No Person to Undertake Work and 2.8.3 Eligibility). This updated process combines the former project based risk assessments and facility certifications. The scope of the former risk assessment process has been widened from discrete project based assessments to an assessment of an applicant’s entire research program. The Biological Safety program permit system registers users and collects / documents information for the investigator’s inventory and overarching risk assessment for an investigator’s research program. Permits are accepted and reviewed by both the Biological Safety Officers and the Biological Safety Advisory Committee. In this part of the process the Biological Safety Officer(s) reviews the general scope of work for the applicant, training, facility certifications as well as the biological agent inventory (held or proposed inventory) for risks including agents with possible dual use potential. In order to receive biosafety program permit approval the committee must be satisfied that the containment level, safety procedures and risk mitigation strategies identified are appropriate for the proposed work. The detailed review conducted by experts appointed to the committee for approval is the most appropriate to identify dual use agents, knowledge, technology or intermediate and final products. A Principal Investigator submits a biosafety program permit application or an amendment to an approved program permit when they receive funding, require approval for a material transfer agreement or other changes pertaining to their research. Amendments which change and investigator’s risk profile will undergo committee review. Funds are released by the Office of Research Services only after the applicant receives approval from the committee.
The biosafety program permit application process is described in greater detail here: http://umanitoba.ca/admin/vp_admin/risk_management/ehso/bio_safety/biopermits.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 in the biosafety program permit process 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 Officers during the biosafety program permit application process and the Biological Safety Advisory Committee biosafety program permit review and approval processes. Failure to abide by the conditions set out in the approved biosafety program permit (Biosafety Program) results in citations of non-compliance according to the Biological Safety Procedure section 2.13 Enforcement.
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 groups 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 amendments to program permits must be supplied for the release of grant funds. Principal Investigators are responsible for establishing Biological Safety program permits in their assigned spaces if they work with biological agents. They are required amend their permits when the information provided as part of their permit application changes. 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. The submitted Biological Safety program permit application is reviewed by the Biological Safety Officer to verify that the declared containment requirements are appropriate. In addition to the Biological Safety Officer(s)’ review, the Biological Safety Advisory Committee reviews the program permit application and the committee Chair gives the final approval.
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 Program permit or they are listed on a valid Biological Safety program 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 a communications portfolio including an email list-serve, internal news articles and social media.
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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