Chapter 3: Regulation of Biohazardous Material and Risk Management Systems

1. Biorisk An Engineering Safety ModulePrepared by Valentin MalenkovReviewed by Prof. Marc AucoinSponsored by: MINERVA (www.safetymanagementeducation.com/)and MITACS Chapter 3: Regulation of Biohazardous Material and Risk Management Systems

2. 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

3. Learning Objectives Learn which legal bodies are responsible for regulating biohazardous material in Canada Understand what activities involving biohazardous materials are regulated by law Know the major Canadian acts and regulations pertaining to biosafety and when they apply Gain an understanding of Biorisk Management Systems

4. Canadian Regulatory Environment for Biosafety

5. 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”

6. 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!

7. 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

8. 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

9. International Agencies Image [1] 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

10. Key Acts, Regulations, and Guidelines

11. 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

12. 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

13. 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

14. Human Pathogens and Toxins Regulations (cont’d) Extensive provisions for existing operations • Existing processes/facilities must comply • Extensive “transitional provisions” • Small business provisions

15. 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

16. 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

17. 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

18. 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)

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. 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 (2nd ed.) already available Available online: • http://canadianbiosafetystandards.collaboration.gc.ca/ • 2nd Ed.: http://canadianbiosafetystandards.collaboration.gc.ca/cbs-ncb/index-eng.php • Also available as an App!

27. 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

28. 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

29. Biorisk Management Systems

30. What is a Biorisk Management System(BMS)? *More on this in Chapter 4 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

31. 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

32. 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

33. 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

34. 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

35. 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

36. 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

37. 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

38. Components of a BMS Biological Safety Manual Biosecurity Plan Medical Surveillance Program Training Program Emergency Response Plan Inventory Control All components guided by risk assessments

39. 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

40. 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

41. Biosecurity Plan (cont’d) Plan developed based on risk assessment Elements of a Biosecurity Plan • Physical Security: measures in place to prevent unauthorized access • Personnel Suitability & Reliability: Training, experience, competency, and screening • Material Accountability: Inventory tracking • Incident & Emergency Response: Reporting, documentation, and response • Information Security: Documentation, collection, transfer and access

42. 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

43. 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

44. 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

45. 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)

46. 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

47. 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)

48. Conclusion

49. 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

50. References [1] http://www.inspection.gc.ca/animals/terrestrial-animals/diseases/reportable/eng/1303768471142/1303768544412