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
Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Module Outline 2 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
Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Learning Objectives 3 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
Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Canadian Regulatory Environment for Biosafety
Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Canadian Regulatory System 5 q Acts passed into law create mandate for regulation q Outline regulatory requirements and goals q Passed into law by federal/provincial governments q Ex. “Reduce sulfide pollution in factory effluents” q Regulations outline actual requirements/limits q Subsidiary to an Act q Body responsible outlined in Acts (Cabinet, Board, Minister, Authorized Body) q Ex. “No more than 0. 05 kg of sulfides may be deposited in the environment per month”
Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Regulation of Biohazardous Material 6 q Biohazardous material highly regulated q Use, importation, transportation, storage, etc q Multiple stakeholders and agencies involved q Cover different aspects of biosafety q Create both legal requirements and recommendations q Legal responsibility to know laws and regulations q Ignorance is not a defense!
Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Agencies Regulating Biosafety 7 q Health Canada q Federal Ministry q Overarching stakeholder (supports agencies) q Public Health Agency of Canada (PHAC) q Human pathogens and quarantine q Pathogen importation q Canadian Food Inspection Agency (CFIA) q Animal pathogens and quarantine q Pathogen importation
Biorisk 8 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Agencies Regulating Biosafety (cont’d) q Environment Canada q Environmental protection (from pathogens) q New substance reporting q Transport Canada q Movement of biohazardous material within Canada q Ownership of shipped materials
Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys International Agencies 9 q No direct jurisdiction, only recommendations q Consolidated research and experience q Provide guidance q Conferences on Biosafety q United Nations q Recommendations on transport and handling q Cartagena Protocol on Biosafety (2003) q Safe handling of living modified organisms q World Health Organization q International health regulations q Global health security q Biorisk management framework Image [1]
Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Key Acts, Regulations, and Guidelines
Biorisk 11 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Human Pathogens and Toxins Act (2009) q PHAC act to protect general population health and safety q Requires permits/licensing for actions with pathogens q q Possession/handling Production Storage Importation q Outlines required minimum security q Security clearance powers and responsibilities
Biorisk 12 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Human Pathogens and Toxins Act (cont’d) q Biological safety officers (BSOs) q Required for licensing q Qualifications and responsibilities in regulations q Fines and incarceration for violation q Maximum $500 000 fine and/or 6 months jail time q Comprehensive schedules (categories of agents) q Full lists of agents sorted by category q Compiled by PHAC
Biorisk 13 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Human Pathogens and Toxins Regulations (2015) q Regulations under Human Pathogens and Toxins Act q q Comes into force December 1, 2015 Legally enforceable under the HPTA q Specific requirements for work with human pathogens q q Licensing for controlled activities Biosafety officer qualifications and duties Facility access/Security Clearance Cut-off quantities for prescribed pathogens and toxins
Biorisk 14 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Human Pathogens and Toxins Regulations (cont’d) q Extensive provisions for existing operations q Existing processes/facilities must comply q Extensive “transitional provisions” q Small business provisions
Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Health of Animals Act (1990) 15 q CFIA Act for the protection for animals and prevention of pathogen spread q Predominantly domesticated animals q Strong focus on “reportable diseases” q q Reporting and control requirements Import/export restrictions empowered Control zones Inspections and searches
Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Health of Animals Act (cont’d) 16 q Fines and incarceration for violation q Maximum $250 000 and/or 2 years jail time q Compensation for animal harm/destruction q Treatment and replacement costs q Withheld if offence is committed under the Act q Full list of reportable diseases available from CFIA[1] q Updated yearly
Biorisk 17 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Health of Animals Regulations (2011) q Regulations under Health of Animals Act q Requirements for handling and importation of animals and pathogens q Importation limited to “quarantine ports” or “inspection ports” q Full list of ports in regulation q Separate importation rules for pathogens and by-products q Permitting requirements outlined (CFIA) q Required inspection and eradication zones q Special provision for bovine Tuberculosis and Brucellosis
Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Health of Animals Regulations (cont’d) 18 q Schedules outline reporting requirements and diseases q Immediate and yearly reporting separate q Testing requirements based on size of flocks q Overlaps and references Reportable Diseases Regulations (1990) q Also updated by CFIA (2012 the latest)
Biorisk 19 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Canadian Environmental Protection Act (1999) q Large Act tangentially related to biosafety q Pollution control q q q Separate divisions for types of pollution Public participation in legislation Enforcement empowered q Control of “Toxic” substances q q q “Toxic” defined as harmful to environment, bio-diversity, humans Empowers Ministry of the Environment to evaluate/add substances Special consideration for some substances q Regulations for toxic substance handling q q Full schedule of toxic substances Sets rules for identifying/quantifying toxicity
Biorisk 20 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys New Substances Notification Regulations (Organisms) q Environment Canada and Health Canada regulations q Organisms in ecosystems and facilities not on Domestic Substances List q Manufacture and import of new organisms q Doesn’t apply to micro-organism not for introduction outside containment facility q q 250 L for higher-risk (CL 2, 3, 4) organisms, 1000 L for others 50 m. L or 50 g on import q Notifications for individual ecozones may be required
Biorisk 21 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys New Substances Notification Regulations (Organisms) (cont’d) q Sets administrative requirements for new organism reporting q Applicable to all recombinant work q Separate schedules for organisms in contained facilities q Extensive information required q Strain history q Biological/ecological properties q Methods for distinguishing
Biorisk 22 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Transportation of Dangerous Goods Act q Legislation put forth by Transport Canada q Transportation of Dangerous Goods Act (S. C. 1992, c. 34) q Transportation of Dangerous Goods Regulatons (SOR/2001 -286) q Regulates transport within Canada q All dangerous goods and means of transport q Road, Rail, Air, Marine q Import/export covered elsewhere
Biorisk 23 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Transportation of Dangerous Goods Act (cont’d) q Strict regulation as preventative measure q q q Quantities and/or concentrations Means of containment requirements Emergency response plans Proper signage Liability for damages q Empowers inspectors from Ministry of Transportation q Monitor through inspection before and during transport q Can take actions necessary to prevent spill q “Reasonable request” compliance
Biorisk 24 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Canadian Biosafety Standards and Guidelines q Replaces 3 older documents q q q 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) q Best biosafety resource for Canadian engineers q Joint effort by PHAC and CFIA q Guidelines, not regulations q Provides information for safe/legal handling q Must be updated to remain current to regulations
25 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Biorisk Canadian Biosafety Standards and Guidelines (cont’d) q Two main sections q Standards: containment and operational requirements q Guidelines: info for achieving standards q Comprehensive overview of biosafety equipment and management q q q Containment Operational practices Risk management programs Biosecurity Medical Surveillance
26 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Biorisk Canadian Biosafety Standards and Guidelines (cont’d 2) q New regulations necessitate updated standards q Human Pathogens and Toxins Regulations q Come into force December 1, 2015 q Updated Biosafety Standards (2 nd ed. ) already available q Available online: q q http: //canadianbiosafetystandards. collaboration. gc. ca/ 2 nd Ed. : http: //canadianbiosafetystandards. collaboration. gc. ca/c bs-ncb/index-eng. php q Also available as an App!
Biorisk 27 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Tying it all together q Knowing Regulations is obligatory q Major regulations outlined here q More specific regulations may apply q Novel substances/organisms reporting regulated q Detailed reporting for recombinants/new organisms q Extensive list of required information q Provides agencies with info. for new regulations q Exact handling requirement not provided q Guidelines available q Heightened controls until risk is determined
Biorisk 28 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Tying it all together (cont’d) q Chain of custody for biohaz. mat. enforced q Custody maintained through full life cycle q Liable party never in question q Ensures stakeholder buy-in q Regulations updated/changed regularly q Agencies strive for up to date information q Release new guidelines to match regulations q Engineers required to stay current with regulations
Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Biorisk Management Systems
Biorisk 30 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys What is a Biorisk Management System(BMS)? q Comprehensive set of SOPs for managing risk from biological hazards q Required by law for higher-risk work q Containment level 2 and above* q All aspects of work with biohazards covered q q Storage, transport, working, disposal All information available q All employees trained and informed q Both Biosafety and Biosecurity *More on this in Chapter 4
Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys What is a BMS? (cont’d) 31 q Extent/complexity varies with facility/organization q Size of facility q q q Scale of labs/equipment Size of entire building Storage capacity q Pathogens being handled q Location of facility q q Proximity to vulnerable populations Transportation requirements
Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys What is a BMS? (cont’d 2) 32 q Biological Safety Officer (BSO) q Assigned as appropriate for facility q Dedicated, part-time, or shared role q Responsible for BMS creation and maintenance q Leads risk assessments q Coordinate training q Liaise with management q Health and Safety Committee q Involved in Biosafety considerations q Coordinate with BSO for biological matters
Biorisk 33 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Why a Management System? q Minimizes risk to personnel and environment q Consistent rules and measures q User input and awareness q Responsibilities clearly outlined q Centralizes biorisk information q Documentation maintenance facilitated
Biorisk 34 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Why a Management System? (cont’d) q Ensures regulatory compliance q Required by law q Saves money in the long run q Facilitates communication and buyin q Demonstrates priority of safety q Involves employees in process of safety
Biorisk 35 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys BMS Stakeholders q Every member of an organization q Biological Safety Officer q Establishes and maintains BMS q Continuity q Management q Reduced accident incidence q Regulatory compliance q Demonstrated priority of safety
Biorisk 36 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys BMS Stakeholders (cont’d) q Employees handling biological agents q Personal safety at work q Knowledge of other work at facility q SOPs to follow q Reporting system for issues q Other Employees q Ex. Cleaning, security, clerical staff q Informed for personal safety q Security preventing blunders
Biorisk 37 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Administrative Buy-in and Controls q Top-down commitment through entire organization q Buy-in needs to start at the top q Culture of biosafety q Biosafety policy q Organization-specific and high-level q Sets out guiding principals and objectives q Sets the scene for BMS development q BSO and Biosafety Committee q Assigned by management q Qualified and trained
Biorisk 38 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
Biorisk 39 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Biological Safety Manual q All SOPs, plans, and policies for biosafety q Documents all components of program q Available to all employees q Developed and maintained by BSO q Must be up to date q Change tracking and notification q Contents and complexity based on Biosafety Policy and Risk Assessments
Biorisk 40 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Biosecurity Plan q Outlines measures preventing misuse of biological materials q Covers theft, loss, misuse, and intentional release q Protects biological agents from people q Collaborative effort q Internal personnel: Lab staff, administration, engineering, BSO, occupational H&S, security q May incorporate local law enforcement
Biorisk 41 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Biosecurity Plan (cont’d) q Plan developed based on risk assessment q 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
Biorisk 42 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Medical Surveillance Program q Regular monitoring of employee health q Both pre-placement and ongoing q Detection of Laboratory Acquired Infections (LAI) q Ensures immuno-competency q Vaccination needs q Identified by risk assessment q Infection response plan q First aid requirements q Emergency medical contacts
Biorisk 43 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Training Program q Essential for effective biosafety program q Training specific to work conducted q Identified by risk assessment q Theoretical knowledge may overlap (understand all biological hazards at the facility) q Proper induction of new personnel q Trainees supervised until trained q Must prove knowledge AND competence
Biorisk 44 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Training Program (cont’d) q Ongoing training q New procedures, organisms, and toxins q Refresher training q Adult learning principals applied q Evaluation and Records q Proves knowledge acquisition and competency q Must be appropriate to subject q Documented for records and audits q Program re-evaluated regularly and updated accordingly
Biorisk 45 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Emergency Response Plan q Integrated into BMS, includes: q q Evacuation routes/exits Safe removal of biohazardous materials/waste Emergency access Notification/reporting/documentation q Regular training required q New employees training q Yearly re-training for higher-risk facility (>CL 1)
Biorisk 46 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Emergency Response Plan (cont’d) q Coordination between external/internal personnel q Individuals not usually at the facility (other facilities, EMS, office staff) q Contact information and instructions available q Safety of EMS in containment zones q Include EMS in planning where necessary
Biorisk 47 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Inventory Control q Protects from misuse/loss q Cradle to grave tracking of materials q Reviewed regularly for discrepancies q Inventory should include: q q Name and description of biological material Quantity and state (powder, liquid, etc) Contact info for personnel responsible All associated permits and documents q Storage and control q Safe storage protocols (minimizing transport) q Controlled access (records included)
Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys Conclusion
Biorisk 49 Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys In Conclusion q Regulations must be understood, and they’re always changing q BMS is complex, unique to the facility, and requires constant work q See CBSG for full guidelines q Next two chapters cover details of various BMS components q Biological risk groups q Containment Levels q Physical Containment equipment
![Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys References [1] http:](https://present5.com/presentation/91a4cdfb7ebce9e9d189e3368ce96c74/image-50.jpg "Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys References [1] http:")
Biorisk Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys References [1] http: //www. inspection. gc. ca/animals/terrestrialanimals/diseases/reportable/eng/1303768471142/1303768544412
Biorisk 51 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 CC 0 1. 0 Universal Public Domain Dedication. Original source: https: //commons. wikimedia. org/wiki/File: Small_Flag_of_the_United_Nati ons_ZP. svg
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
Biorisk 1. 2. 3. 4. 5. 6. Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys True of False: Regulations are written under legal Acts in order to fulfill their goals True or False: Work with pathogens is regulated by one agency in Canada, the Public Health Agency of Canada Where can you find information on regulation of Toxic materials, along with a list of materials considered toxic? You are trying to get some biological samples containing a human pathogen transported to your facility. What act does this activity fall under? What is the best source of information on guidelines for managing a Biological Management System in Canada? Is there a set composition which is required of every Biosafety Management System for handling highly infectious pathogens in Canada?
Biorisk 7. Chapter 3: Regulation of Biohaz. Mat. and Risk Man. Sys 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?
Скачать презентацию Biorisk An Engineering Safety Module Prepared by Valentin
91a4cdfb7ebce9e9d189e3368ce96c74.ppt