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SSBA Regulatory Scheme Road Show

SSBA Regulatory Scheme Road Show. Welcome and Introductions. Speakers. Dr Gary Lum – Assistant Secretary Health Emergency Management Branch (DoHA) Wendy Barry – Assistant Director Laboratory Capacity & Regulation Section (DoHA) Nicole Hutchins – Assistant Director a/g

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SSBA Regulatory Scheme Road Show

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  1. SSBA Regulatory SchemeRoad Show

  2. Welcome and Introductions

  3. Speakers • Dr Gary Lum – Assistant Secretary • Health Emergency Management Branch (DoHA) • Wendy Barry – Assistant Director • Laboratory Capacity & Regulation Section (DoHA) • Nicole Hutchins – Assistant Director a/g • Laboratory Capacity & Regulation Section (DoHA) • Andrew Straffon • Australian CBRN Data Centre, AFP • Jurisdictional Representative

  4. Office of Health Protection

  5. Health Emergency Management

  6. Program Outline • Setting the Scene • International Obligations • Technical Feasibility and Risk Report • Jurisdictional Context • National Health Security Act 2007 • National Health Security Regulations 2008 • SSBA Standards • Reporting Requirements and Timeframes • The Inspection Process • SSBA Publications

  7. SSBA Road ShowObjectives • To raise awareness and provide an overview of the SSBA Regulatory Scheme

  8. Evaluation • Evaluation forms have been provided • We would like you to complete the evaluation form • You may choose to complete this form during the course of the day

  9. Setting the Scene

  10. Outline • Introduction • The COAG Report

  11. Introduction • Terrorism • Increased global risk of terrorism • 11 September 2001 • Anthrax attacks in 2001 • Biological Weapons Convention • Expanding knowledge of biotechnology • Legitimate research and the dual use dilemma (legitimate and malicious use of the same agent)

  12. COAG Review • 2002 • COAG review of hazardous materials • 2006 • Banks Report • 2007 • COAG Report recommended a regulatory scheme for security-sensitive biological agents (SSBAs)

  13. The COAG Report • Purpose • Recommendations of the COAG Report • Risk management was applied • Balance between counter-terrorism concerns and industry interests • Maintain access to SSBAs for those with legitimate need

  14. International Obligations Presented byThe Department of Foreign Affairs

  15. Technical Feasibility and Risk Report Presented byThe Australian CBRN Data Centre

  16. Jurisdictional Context

  17. National Health SecurityLegislation

  18. Outline • Introduction • National Health Security Act 2007 • Amendments to the NHS Act • National Health Security Regulations 2008 • Amendments to the NHS Regulations • Exemptions • List of SSBA

  19. National Health Security Act 2007 • The National Health Security Bill was passed in Parliament on 20 September 2007 • Commencement • Part 2 - commenced on 29 March 2008 • Part 3 - commenced on 31 January 2009

  20. National Health Security Act 2007 (2) Two main operative parts • Part 2: • Surveillance arrangements to support responses to national and international public health emergencies • Assist repatriation of victims of overseas mass casualty events • Part 3: • Establishes the regulation of security sensitive biological agents (SSBAs)

  21. SSBA Regulatory SchemePart 3 of the NHS Act • How SSBAs will be handled • Who will be regulated • Who is exempt • Information collection process • Checking of information

  22. Role of the Secretary • Secretary of the Australian Government’s Department of Health and Ageing • Responsible for the administration and enforcement of the NHS Act. For Example: • Deciding to register an entity on the National Register • Directing an entity to dispose of SSBAs or to arrange for that disposal

  23. Legitimate Purpose • The NHS Act defines what is a ‘legitimate purpose’ (s41) • Legitimate purposes are: • Scientific or medical work • Diagnostic analysis of samples • Forensics • Research • Temporary Registration

  24. Amendments to the Act • Consultation on the Security Sensitive Biological Agents (SSBA) Regulatory Scheme has identified measures to enhance the operation of Part 3 of the NHS Act • Introduced 24 June 2009 • Aim for passing Spring 2009

  25. Amendments to the Act (2) • Emergency disease situation • Handling suspected SSBAs • Inspector powers • Reporting to law enforcement • ‘Nil’ reporting • Cancellation of registration • New definition of ‘biological agents’

  26. Amendments to the Act Emergency Disease Situation • Flexible - not to impede diagnosis and treatment • Minister able to suspend some or all regulatory obligations for an SSBA • Legislative instrument which may be varied or revoked, to address the situation • Advised by relevant experts • Maintain adequate controls

  27. Amendments to the ActHandling a Suspected SSBA • Regulation of biological agents suspected of being SSBAs • Usual testing processes • Presumptive identification of an SSBA • Requirement to report: • Destruction • Confirmatory testing • Comply with relevant SSBA Standards • Reporting requirements

  28. Amendments to the ActCancellation of Registration • No longer handling SSBA • Entities not expecting to handle SSBAs in future • Application to the Secretary • No longer subject to regulatory obligations

  29. National Health Security Regulations 2008 • The NHS Act enables regulations to provide further specific detail for the SSBA Regulatory Scheme • Work in conjunction with the SSBA Standards to provide operational detail

  30. What is in the Regulations? • The Regulations deal with: • Additional detail for inclusion on the National Register (3.1) • Additional reportable events (3.4) • Time frames for reporting (3.5) • Agencies that the Secretary may provide a report to (3.71) • Inspector identity cards (3.70) • Exempt entities (3.2)

  31. Amendments to theNHS Regulations • Required as a result of the NHS Act Amendments • Reporting reportable events to police • ‘Nil’ Reporting • Expected to be finalised December 2009

  32. Exemptions • NHS Act s40 • Transport companies • NHS Regulations (s3.2) • Border security or law enforcement agencies • Depot or warehouse licence holders • A person or animal who is infected by an SSBA

  33. List of SSBA • NHS Act s31–s34 • 12 Tier 1 SSBA • Tier 1 regulation commenced on 31 January 2009 • 10 Tier 2 SSBA • Tier 2 agents will be regulated from January 2010

  34. Abrin (5mg) Bacillus anthracis (Anthrax—virulent forms) Botulinum toxin (0.5mg) Ebolavirus Foot-and-mouth disease virus Highly pathogenic influenza virus, infecting humans (such as 1918 pandemic Influenzavirus A and Influenzavirus A H5N1) Marburgvirus Ricin (5mg) Rinderpest virus SARS coronavirus Variola virus (Smallpox) Yersinia pestis (Plague) Tier 1 SSBA

  35. African swine fever virus Capripoxvirus (Sheep pox virus and Goat pox virus) Classical swine fever virus Clostridium botulinum (Botulism; toxin-producing strains) Francisella tularensis (Tularæmia) Lumpy skin disease virus Peste-des-petits-ruminants virus Salmonella Typhi (Typhoid fever) Vibrio choleræ (Cholera) (serotypes O1 and O139 only) Yellow fever virus (non-vaccine strains) ProposedTier 2 SSBA

  36. ActivityQuiz • What part of the NHS Act covers the regulation of SSBA? • What are 2 amendments to the NHS Act? • What do the NHS Regulations do? • Name one exemption from the SSBA Regulatory Scheme? • When will Tier 2 SSBAs be regulated?

  37. Security Sensitive Biological Agent (SSBA) Standards

  38. Outline • Commencement • Part 1 Scope and Definitions • Part 2 Risk and Incident Management • Part 3 Personnel • Part 4 Physical security • Part 5 Information management • Part 6 Transport • Part 7 Inactivation and decontamination • Part 8 SSBA management system requirements • Part 9 Bibliography • Amendments

  39. SSBA Standards • SSBA Standards apply to any entity that handles one or more SSBAs and is not exempt • Specify compliance requirements • May be different requirements for Tier 1 SSBA versus Tier 2 SSBA • Registered but not handling no longer required to comply with the Standards

  40. Commencement • Part 1 and Part 2 • commenced 31 January 2009 • Remaining Parts • commenced 1 July 2009 • Background checking has been removed from Part 3 of the Standards

  41. Part 1 Scope and Definitions • Sets out the overall scope of the Standards • Normative references regarding other legislation • Terms and definitions

  42. Part 2Risk and Incident Management • Minimum requirements for the risk assessment and risk management process • Minimum requirements for incident management and review • Risk assessment must be proactive rather than reactive

  43. Part 2Risk and Incident Management (2) • Risk assessment • Timing and scope • Hazard/risk identification • Risk assessment process • Risk management plan • Incident management • Review

  44. Tier 1 Versus Tier 2 Risk and Incident Management • Subclause 2.2.3 – Risk assessment process • Vulnerability analysis undertaken for Tier 1

  45. Risk and Incident Management Summary • Undertake a risk assessment and produce a risk management plan • Risk assessment and risk management process important for determining controls for rest of SSBA Standards • Incident management • Reviewing risk plans

  46. Part 3Personnel • Requirements for personnel management to assist in addressing the risk associated with human behaviour • Background checking has been removed from clauses 3.3 and 3.4

  47. Part 3Personnel (2) • Responsible Officers • Authorised persons • Approved persons • Recruitment • Training and competency • Behavioural factors • Exclusion

  48. Tier 1 Versus Tier 2Personnel • Clause 3.5 – Approved Persons • Escorted by an authorised person (Tier 1) • Supervised by an authorised person (Tier 2) • Clause 3.6 – Training Competency • Personal security awareness training (Tier 1)

  49. Personnel Summary • Responsible Officer • Deputy Responsible Officer • Authorised persons • Approved persons • Recruitment • Training and competency • Behavioural factors • Exclusion

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