2. 2015 Biosafety Symposium
• Human Pathogens and Toxins Act/
Regulations (HPTA/R) licence
requirements
• Administrative Oversight Plan
• Requirements of the Canadian
Biosafety Standards (CBS)
– Physical
– Operational
• Challenges of project management
• ISO 14001 and application to
biosafety program
Outline
3. 2015 Biosafety Symposium
HPTA and HPTR
To be in full force on Dec. 1, 2015
Licence will be required for handling
(as well as possessing, using,
producing or even just storing)
biological material containing a pathogen or toxin
affecting humans
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Licence Requirements
Licence application will require:
1. Administrative Oversight Plan
showing that applicant will:
manage and control biosafety and biosecurity
risks in appropriate manner.
2. Designation of a Biological Safety Officer (BSO)
5. 2015 Biosafety Symposium
Elements of the
Administrative Oversight Plan (1)
• Commitment from senior management to manage and
control biosafety and biosecurity risks
• Roles and responsibilities of all stakeholders
• Communication and consultation
• Monitoring and reviewing of the Plan
6. 2015 Biosafety Symposium
High level overview of how
biosafety/biosecurity risks are:
o identified
o assessed
o managed
o controlled
Coverage of all work areas and
all individuals
Overarching RA is one requirement from the CBS (4.1.6)
Elements of the
Administrative Oversight Plan (2)
Overarching Risk Assessment
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Compliance with the CBS
A condition of the licence
Applicable requirements from CBS
should be dependant on:
– Containment level
– Work area
– Prion?
(online App ?)
8. 2015 Biosafety Symposium
Classes of requirements in CBS
1 - Physical Containment
– Infrastructure
• Structure, location, barrier, access, finishes, etc.
– Air handling and services
– Biosafety equipment and decontamination systems
9. 2015 Biosafety Symposium
Classes of requirements in CBS
2 - Operational Practice (Programs)
Programs to be implemented:
– Biosafety
– Medical Surveillance
– Training
– Housekeeping and maintenance
– Documentation
Plans to be prepared:
– Biosecurity
– Emergency Response
10. 2015 Biosafety Symposium
Classes of requirements in CBS
2 - Operational Practice (Procedures)
Work Practices (SOPs):
– Entry/exit
• Individuals
• Animals
• Materials
– PPEs
– Experimental work
– Waste decontamination
– Transport of biological material
• Internal and external
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Classes of requirements in CBS
3 - Performance and Verification Tests
Tests to be performed at prescribed frequency
and/or upon specific events:
– Validation of decontamination systems (loads/
indicators)
– Visual inspections of different elements
– Certification of BSCs, HEPAs, etc.
– Controlled access
– Safe failures
– Specific tests
12. 2015 Biosafety Symposium
Challenges for program management
1) Physical components:
– easily measured
– static
2) Program development and management:
– more subjective areas
– reviewing, updating
CBS defines the programs to be addressed but not the
process for program development and management.
13. 2015 Biosafety Symposium
• family of standards relating to the use of environmental
management systems (EMS)
• concerned with environmental assessement of various
processes
• not specifically for Health and Safety,
• been used to develop, implement, manage EHS
programs
• ISO 14001: requirements for the establishment and
management of an EMS
• ISO 14004: general guidelines for an EMS
• ISO 14031: environmental performance evaluation
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ISO 14001 – section 4
4.2 - Policy and goal setting by Management
4.3 – Plan
4.3.1 – Environmental aspects
4.3.2 – Legal requirements
4.3.3 – Objectives and targets
4.4 – Do
4.4.1 – Roles and responsibilities
4.4.2 – Competence and training
4.4.3 – Communication
4.4.4 – Documentation
4.4.7 – Emergency prepardness
4.5 – Check
4.5.1 – Monitoring
4.5.2 – Evaluation of compliance
4.5.3 – Non-conformity
4.5.4 – Control of records
4.5.7 – Audits
4.6 – Act
Management Review
15. 2015 Biosafety Symposium
ISO 14001 – Application to the
Administrative Oversight Plan
Plan
Method to perform overarching
risk assessment
Do
Roles and responsibilities
Communication
Consultation
Check
Monitoring of the plan
Act
Management Review
Commitment to biosafety/biosecurity from Senior Management
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ISO 14001 – CBS
Biosafety Program - Planning
RAs:
• Overarching
• Biosecurity
• Training needs
• Medical Surveillance
• Local RAs
Legal requirements
• HPTA/HPTR
• CBS
Gap analysis
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ISO 14001 – CBS
Biosafety Program - Planning
Objectives, targets and programs
• Set objectives and timelines for items identified in the
gap analysis
• Develop the programs and plans based on RAs:
• Biosecurity
• Medical Surveillance
• Training
• Emergency Response Plan
• SOPs as determined by the local RAs
• Determine appropriate indicators to evaluate program
efficacy
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ISO 14001 – CBS
Biosafety Program - Implementation
• Roles and responsibilities
• Implement the various points
from the Planning stage
• Communicate the relevant
information to all parties at all
levels
• Document the programs and
actions and develop appropriate
document retention
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ISO 14001 – CBS
Biosafety Program - Checking
• Monitor the performance of the different
programs with specific indicators (ie exposure,
injuries, evacuation times, etc.)
• Evaluate the compliance of all actors by
performing audits
• Document the instances of non-conformity
• Evaluate the document control protocols to
ensure appropriate conservation/destruction of
documents
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ISO 14001 – CBS
Biosafety Program - Acting
Management Review
Review of the program at least annually or in case of
important changes or serious events
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Conclusions
Commitment
Strong commitment to safety from management
Engagement
Engagement of all
stakeholders in the
process
–> transparency
Collaboration
Collaboration from everyone is essential for
continual improvement of all aspects of safety
22. 2015 Biosafety Symposium
Mireille Cartier, PhD
Biosafety Specialist
mireille@krmc.ca
KRMC Inc.
www.krmc.ca
2015 Biosafety Symposium
Project Presentation – Completed
TIME FOR QUESTIONS
