Biosafety and biosecurity governance framework
This document highlights the key component of the Biosafety and Biosecurity Governance Framework; also known to the Public Health Agency of Canada as the “Plan of Administrative Oversight”. The full document is provided at the time a Biohazardous Material Use Certificate is issued, or upon request.
Objective is to achieve:
Biosafety: containment principles, technologies, and practices implemented to prevent unintentional exposure to infectious material and toxins, or their accidental release.
Biosecurity: security measures designed to prevent the loss, theft, misuse, diversion, or intentional release of pathogens, toxins, and other related assets.
Biosurety: the combination of security, biosafety, agent accountability, and personnel reliability needed to prevent unauthorized access to select agents of bioterrorism.
Through the use of:
Oversight & accountability
- Roles and Responsibilities
- Institutional Oversight and Program Management
- Academic and Research Activities and Facility Infrastructure
Corporate policy and directives
- Biosafety and Biosecurity Policy
- Institutional Biosafety Approval
- Biorisk Management Program
Biorisk program
- Risk Identification, Assessment and Control
- Implementation and Operational Procedures
- Compliance Monitoring and Reporting
The Biorisk Management Program comprises:
The founding principles are:
- Accountability/Responsibility Framework
- Communication/Education
- Compliance and Monitoring Activities
- Documentation and Data Management, and
- Security
These principles are then translated into thirteen operational program elements:
- Institutional Biosafety Approval
- Training /Education
- Compliance Verification
- Inventory Control (acquisition & transfers)
- Security
- Transportation
- Monitoring (medical, performance)
- Waste Management
- Public Awareness/Signage
- Decommission
- Inspections/Investigations/Audits
- Reporting (internal/external)
- Program Review
Biosafety Management Information System is used to as a recording and planning tool:
- Biosafety Program Overview
- Acts and Regulations
- Compliance
- Data Management
- Chronological Activity Journal
- Policies and Procedures
- Central File
- Archives
Biosafety manual
* This document is currently in translations. Due to regulatory compliance requirements, it is presently being made available in English.