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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
SSBA Road ShowObjectives • To raise awareness and provide an overview of the SSBA Regulatory Scheme
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
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)
COAG Review • 2002 • COAG review of hazardous materials • 2006 • Banks Report • 2007 • COAG Report recommended a regulatory scheme for security-sensitive biological agents (SSBAs)
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
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
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
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)
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
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
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
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’
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
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
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
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
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)
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
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
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
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?
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
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
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
Part 1 Scope and Definitions • Sets out the overall scope of the Standards • Normative references regarding other legislation • Terms and definitions
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
Part 2Risk and Incident Management (2) • Risk assessment • Timing and scope • Hazard/risk identification • Risk assessment process • Risk management plan • Incident management • Review
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
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
Part 3Personnel (2) • Responsible Officers • Authorised persons • Approved persons • Recruitment • Training and competency • Behavioural factors • Exclusion
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)
