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Bio Risk management in labs

1. Biorisk
An Engineering Safety Module
Prepared by Valentin Malenkov
Reviewed by Prof. Marc Aucoin
Sponsored by: MINERVA (
www.safetymanagementeducation.com/)
and MITACS
Chapter 3: Regulation of Biohazardous
Material and Risk Management
Systems

2. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Module Outline
Chapter 1: Introduction to Biorisk
Chapter 2: Microorganisms, Pathogens, and
Toxins
Chapter 3: Regulation of Biohazardous
Materials and Risk Management
Systems
Chapter 4: Risk Assessments, Risk Groups,
and Containment Levels
Chapter 5:Biohazardous Material
Containment
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3. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Learning Objectives
1.Learn which legal bodies are
responsible for regulating
biohazardous material in Canada
2.Understand what activities involving
biohazardous materials are regulated
by law
3.Know the major Canadian acts and
regulations pertaining to biosafety and
when they apply
4.Gain an understanding of Biorisk
Management Systems
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4. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Canadian Regulatory Environment
for Biosafety

5. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Canadian Regulatory System
Acts passed into law create mandate for
regulation
Outline regulatory requirements and goals
Passed into law by federal/provincial governments
Ex. “Reduce sulfide pollution in factory effluents”
Regulations outline actual requirements/limits
Subsidiary to an Act
Body responsible outlined in Acts (Cabinet, Board,
Minister, Authorized Body)
Ex. “No more than 0.05kg of sulfides may be
deposited in the environment per month”
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6. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Regulation of Biohazardous Material
Biohazardous material highly regulated
Use, importation, transportation, storage, etc
Multiple stakeholders and agencies
involved
Cover different aspects of biosafety
Create both legal requirements and
recommendations
Legal responsibility to know laws and
regulations
Ignorance is not a defense!
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Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Agencies Regulating Biosafety
Health Canada
Federal Ministry
Overarching stakeholder (supports agencies)
Public Health Agency of Canada (PHAC)
Human pathogens and quarantine
Pathogen importation
Canadian Food Inspection Agency (CFIA)
Animal pathogens and quarantine
Pathogen importation
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Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Agencies Regulating Biosafety
(cont’d)
Environment Canada
Environmental protection (from
pathogens)
New substance reporting
Transport Canada
Movement of biohazardous material
within Canada
Ownership of shipped materials
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Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
International Agencies
No direct jurisdiction, only recommendations
Consolidated research and experience
Provide guidance
Conferences on Biosafety
United Nations
Recommendations on transport and handling
Cartagena Protocol on Biosafety (2003)
Safe handling of living modified organisms
World Health Organization
International health regulations
Global health security
Biorisk management framework
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Image [1]

10. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Key Acts, Regulations, and
Guidelines

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Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Human Pathogens and Toxins Act
(2009)
PHAC act to protect general
population health and safety
Requires permits/licensing for actions
with pathogens
Possession/handling
Production
Storage
Importation
Outlines required minimum security
Security clearance powers and
responsibilities
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Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Human Pathogens and Toxins Act
(cont’d)
Biological safety officers (BSOs)
Required for licensing
Qualifications and responsibilities in
regulations
Fines and incarceration for violation
Maximum $500 000 fine and/or 6 months jail
time
Comprehensive schedules (categories of
agents)
Full lists of agents sorted by category
Compiled by PHAC
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Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Human Pathogens and Toxins
Regulations (2015)
Regulations under Human Pathogens and
Toxins Act
Comes into force December 1, 2015
Legally enforceable under the HPTA
Specific requirements for work with human
pathogens
Licensing for controlled activities
Biosafety officer qualifications and duties
Facility access/Security Clearance
Cut-off quantities for prescribed pathogens and toxins
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Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Human Pathogens and Toxins
Regulations (cont’d)
Extensive provisions for existing
operations
Existing processes/facilities must comply
Extensive “transitional provisions”
Small business provisions
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Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Health of Animals Act (1990)
CFIA Act for the protection for animals
and prevention of pathogen spread
Predominantly domesticated animals
Strong focus on “reportable diseases”
Reporting and control requirements
Import/export restrictions empowered
Control zones
Inspections and searches
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16. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Health of Animals Act (cont’d)
Fines and incarceration for violation
Maximum $250 000 and/or 2 years jail
time
Compensation for animal
harm/destruction
Treatment and replacement costs
Withheld if offence is committed under the
Act
Full list of reportable diseases
available from CFIA
[1]
Updated yearly
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17. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Health of Animals Regulations
(2011)
Regulations under Health of Animals Act
Requirements for handling and importation
of animals and pathogens
Importation limited to “quarantine ports” or
“inspection ports”
Full list of ports in regulation
Separate importation rules for pathogens and
by-products
Permitting requirements outlined (CFIA)
Required inspection and eradication zones
Special provision for bovine Tuberculosis and
Brucellosis
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18. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Health of Animals Regulations (cont’d)
Schedules outline reporting
requirements and diseases
Immediate and yearly reporting separate
Testing requirements based on size of
flocks
Overlaps and references Reportable
Diseases Regulations (1990)
Also updated by CFIA (2012 the latest)
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19. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Canadian Environmental Protection Act
(1999)
Large Act tangentially related to biosafety
Pollution control
Separate divisions for types of pollution
Public participation in legislation
Enforcement empowered
Control of “Toxic” substances
“Toxic” defined as harmful to environment, bio-diversity,
humans
Empowers Ministry of the Environment to evaluate/add
substances
Special consideration for some substances
Regulations for toxic substance handling
Full schedule of toxic substances
Sets rules for identifying/quantifying toxicity
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20. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
New Substances Notification
Regulations (Organisms)
Environment Canada and Health Canada
regulations
Organisms in ecosystems and facilities not on
Domestic Substances List
Manufacture and import of new organisms
Doesn’t apply to micro-organism not for
introduction outside containment facility
250L for higher-risk (CL 2,3,4) organisms, 1000L for
others
50mL or 50g on import
Notifications for individual ecozones may
be required
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21. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
New Substances Notification
Regulations (Organisms) (cont’d)
Sets administrative requirements for
new organism reporting
Applicable to all recombinant work
Separate schedules for organisms in
contained facilities
Extensive information required
Strain history
Biological/ecological properties
Methods for distinguishing
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22. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Transportation of Dangerous
Goods Act
Legislation put forth by Transport Canada
Transportation of Dangerous Goods Act (S.C.
1992, c. 34)
Transportation of Dangerous Goods
Regulatons (SOR/2001-286)
Regulates transport within Canada
All dangerous goods and means of transport
Road, Rail, Air, Marine
Import/export covered elsewhere
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23. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Transportation of Dangerous Goods
Act (cont’d)
Strict regulation as preventative measure
Quantities and/or concentrations
Means of containment requirements
Emergency response plans
Proper signage
Liability for damages
Empowers inspectors from Ministry of
Transportation
Monitor through inspection before and during
transport
Can take actions necessary to prevent spill
“Reasonable request” compliance
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24. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Canadian Biosafety Standards and
Guidelines
Replaces 3 older documents
Human Pathogens and Toxins: Laboratory Biosafety
Guidelines (PHAC)
Terrestrial Animal Pathogens: Containment Standards
for Veterinary Facilities (CFIA)
Prions: Containment Standards for Laboratories,
Animal Facilities, and Post Mortem Rooms Handling
Prion Disease Agents (CFIA)
Best biosafety resource for Canadian
engineers
Joint effort by PHAC and CFIA
Guidelines, not regulations
Provides information for safe/legal handling
Must be updated to remain current to regulations
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25. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Canadian Biosafety Standards and
Guidelines (cont’d)
Two main sections
Standards: containment and operational
requirements
Guidelines: info for achieving standards
Comprehensive overview of biosafety
equipment and management
Containment
Operational practices
Risk management programs
Biosecurity
Medical Surveillance
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26. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Canadian Biosafety Standards and
Guidelines (cont’d 2)
New regulations necessitate updated
standards
Human Pathogens and Toxins Regulations
Come into force December 1, 2015
Updated Biosafety Standards (2
nd
ed.) already
available
Available online:
http://canadianbiosafetystandards.collaboration.gc.ca/
2
nd
Ed.:
http://canadianbiosafetystandards.collaboration.gc.ca/c
bs-ncb/index-eng.php
Also available as an App!
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27. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Tying it all together
Knowing Regulations is obligatory
Major regulations outlined here
More specific regulations may apply
Novel substances/organisms reporting
regulated
Detailed reporting for recombinants/new
organisms
Extensive list of required information
Provides agencies with info. for new regulations
Exact handling requirement not provided
Guidelines available
Heightened controls until risk is determined
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28. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Tying it all together (cont’d)
Chain of custody for biohaz. mat.
enforced
Custody maintained through full life cycle
Liable party never in question
Ensures stakeholder buy-in
Regulations updated/changed regularly
Agencies strive for up to date information
Release new guidelines to match regulations
Engineers required to stay current with
regulations
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29. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Biorisk Management Systems

30. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
What is a Biorisk Management
System(BMS)?
Comprehensive set of SOPs for
managing risk from biological hazards
Required by law for higher-risk work
Containment level 2 and above*
All aspects of work with biohazards covered
Storage, transport, working, disposal
All information available
All employees trained and informed
Both Biosafety and Biosecurity
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*More on this in Chapter 4

31. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
What is a BMS? (cont’d)
Extent/complexity varies with
facility/organization
Size of facility
Scale of labs/equipment
Size of entire building
Storage capacity
Pathogens being handled
Location of facility
Proximity to vulnerable populations
Transportation requirements
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32. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
What is a BMS? (cont’d 2)
Biological Safety Officer (BSO)
Assigned as appropriate for facility
Dedicated, part-time, or shared role
Responsible for BMS creation and
maintenance
Leads risk assessments
Coordinate training
Liaise with management
Health and Safety Committee
Involved in Biosafety considerations
Coordinate with BSO for biological matters
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33. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Why a Management System?
Minimizes risk to personnel and
environment
Consistent rules and measures
User input and awareness
Responsibilities clearly outlined
Centralizes biorisk information
Documentation maintenance facilitated
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34. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Why a Management System?
(cont’d)
Ensures regulatory compliance
Required by law
Saves money in the long run
Facilitates communication and buy-
in
Demonstrates priority of safety
Involves employees in process of
safety
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35. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
BMS Stakeholders
Every member of an organization
Biological Safety Officer
Establishes and maintains BMS
Continuity
Management
Reduced accident incidence
Regulatory compliance
Demonstrated priority of safety
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36. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
BMS Stakeholders (cont’d)
Employees handling biological agents
Personal safety at work
Knowledge of other work at facility
SOPs to follow
Reporting system for issues
Other Employees
Ex. Cleaning, security, clerical staff
Informed for personal safety
Security preventing blunders
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37. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Administrative Buy-in and
Controls
Top-down commitment through entire
organization
Buy-in needs to start at the top
Culture of biosafety
Biosafety policy
Organization-specific and high-level
Sets out guiding principals and objectives
Sets the scene for BMS development
BSO and Biosafety Committee
Assigned by management
Qualified and trained
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38. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Components of a BMS
1.Biological Safety Manual
2.Biosecurity Plan
3.Medical Surveillance Program
4.Training Program
5.Emergency Response Plan
6.Inventory Control
All components guided by risk
assessments
38

39. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Biological Safety Manual
All SOPs, plans, and policies for
biosafety
Documents all components of program
Available to all employees
Developed and maintained by BSO
Must be up to date
Change tracking and notification
Contents and complexity based on
Biosafety Policy and Risk Assessments
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40. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Biosecurity Plan
Outlines measures preventing misuse of
biological materials
Covers theft, loss, misuse, and intentional
release
Protects biological agents from people
Collaborative effort
Internal personnel: Lab staff, administration,
engineering, BSO, occupational H&S, security
May incorporate local law enforcement
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41. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Biosecurity Plan (cont’d)
Plan developed based on risk assessment
Elements of a Biosecurity Plan
1.Physical Security: measures in place to
prevent unauthorized access
2.Personnel Suitability & Reliability: Training,
experience, competency, and screening
3.Material Accountability: Inventory tracking
4.Incident & Emergency Response: Reporting,
documentation, and response
5.Information Security: Documentation,
collection, transfer and access
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42. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Medical Surveillance Program
Regular monitoring of employee health
Both pre-placement and ongoing
Detection of Laboratory Acquired Infections
(LAI)
Ensures immuno-competency
Vaccination needs
Identified by risk assessment
Infection response plan
First aid requirements
Emergency medical contacts
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43. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Training Program
Essential for effective biosafety program
Training specific to work conducted
Identified by risk assessment
Theoretical knowledge may overlap
(understand all biological hazards at the
facility)
Proper induction of new personnel
Trainees supervised until trained
Must prove knowledge AND competence
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44. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Training Program (cont’d)
Ongoing training
New procedures, organisms, and toxins
Refresher training
Adult learning principals applied
Evaluation and Records
Proves knowledge acquisition and
competency
Must be appropriate to subject
Documented for records and audits
Program re-evaluated regularly and
updated accordingly
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45. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Emergency Response Plan
Integrated into BMS, includes:
Evacuation routes/exits
Safe removal of biohazardous
materials/waste
Emergency access
Notification/reporting/documentation
Regular training required
New employees training
Yearly re-training for higher-risk facility (>CL1)
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46. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Emergency Response Plan
(cont’d)
Coordination between
external/internal personnel
Individuals not usually at the facility
(other facilities, EMS, office staff)
Contact information and instructions
available
Safety of EMS in containment zones
Include EMS in planning where
necessary
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47. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Inventory Control
Protects from misuse/loss
Cradle to grave tracking of materials
Reviewed regularly for discrepancies
Inventory should include:
Name and description of biological material
Quantity and state (powder, liquid, etc)
Contact info for personnel responsible
All associated permits and documents
Storage and control
Safe storage protocols (minimizing transport)
Controlled access (records included)
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48. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Conclusion

49. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
In Conclusion
Regulations must be understood, and
they’re always changing
BMS is complex, unique to the facility,
and requires constant work
See CBSG for full guidelines
Next two chapters cover details of
various BMS components
Biological risk groups
Containment Levels
Physical Containment equipment
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50. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
References
[1] http://www.inspection.gc.ca/animals/terrestrial-animals/diseases/reportable/eng/
1303768471142/1303768544412

51. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
Attribution for images used
1.“Small Flag of the United Nations ZP”. This file is made available
under the Creative Commons CC0 1.0 Universal Public Domain
Dedication. Original source:
https://commons.wikimedia.org/wiki/File:Small_Flag_of_the_United_Nati
ons_ZP.svg
51

52. Biorisk
An Engineering Safety Module
Prepared by Valentin Malenkov
Reviewed by Prof. Marc Aucoin
Sponsored by: MINERVA (
www.safetymanagementeducation.com/)
and MITACS
Chapter 3: Quiz

53. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
1.True of False: Regulations are written under legal Acts in
order to fulfill their goals
2.True or False: Work with pathogens is regulated by one
agency in Canada, the Public Health Agency of Canada
3.Where can you find information on regulation of Toxic
materials, along with a list of materials considered toxic?
4.You are trying to get some biological samples containing
a human pathogen transported to your facility. What act
does this activity fall under?
5.What is the best source of information on guidelines for
managing a Biological Management System in Canada?
6.Is there a set composition which is required of every
Biosafety Management System for handling highly
infectious pathogens in Canada?

54. Biorisk
Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys
7.True or False: BMSs require only the buy-in of the
Biosafety Officer and personnel handling
8.What part of the BMS deals with preventing intentional
theft and release of the materials at your facility.
9.True or False: New employees require extensive medical
evaluation and possibly vaccination before beginning
work with pathogens.
10.Once materials have arrived and are stored at a facility,
does their inventory need to be tracked?