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• TheÌýÌýlegislates the regulatory scheme. Part 3 of the National Health Security Act 2007 establishes the regulatory scheme for entities and facilities that handle suspected or known SSBAs.
• TheÌýÌý(NHS Regulations) support the Act by providing operational detail about the SSBA Regulatory Scheme.

The inclusion of agents on the List is derived from the Council of Australian Governments (COAG)ÌýReport on the Regulation and Control of Biological Agents, which developed the COAG Biological Agents list (the COAG list) in November 2006. The working group assessed nearly 200 biological agents and using specified criteria, divided them into two Tiers: Tier 1 agents pose the greatest risk to Australia, while Tier 2 agents are rated less likely to pose a security risk.

Agents considered to be of safety concern are included on the List of Security Sensitive Biological Agents (the List of SSBAs). Regulation of Tier 1 SSBAs included on the List commenced in January 2009. On 17 November 2009 the List of SSBAs was varied to also include Tier 2 agents. The regulation of Tier 2 agents commenced on 31 January 2010.

Note: Following a review of the List of SSBAs, effective 14 March 2016,ÌýSalmonella TyphiÌý(Typhoid) andÌýVibrio choleraeÌý(Cholera) (serotypes O1 and O139) were removed from the list of SSBAs. ThusÌýS. TyphiÌýandÌýV. choleraeÌýare no longer considered SSBAs and thus are not subject to the requirements ofÌýtheÌýNational Health Security Act 2007.

If you intend to handle any agent on the List of SSBAs youÌýmustÌýcontact theÌýOffice of Research Ethics, Compliance & IntegrityÌýin order to register the SSBAs.

ÌýPlease note:

1. Tier 1 agents pose the greatest risk to Australia, while Tier 2 agents are rated less likely to pose a security risk.
2. The agents above only refer to infectious, viable and pathogenic organisms or active toxins.
3. Highly pathogenic influenza virus infecting humans' include influenza viral strains that fulfil all the criteria listed below:
   • Considered highly pathogenic in usual host animal;
   • Proven infection of humans; and
   • Involved in an outbreak of human disease.
   Examples of such viral strains include the 1918 pandemicÌýInfluenza virus AÌýandÌýInfluenza virus AÌýH5N1.
4. Botulinum toxinÌýdoes not refer to a form approved for therapeutic use under theÌýTherapeutic Goods Act 1989. For example, the forms of Botulinum toxin approved for therapeutic use and known under their commercial names Botoxâ„¢ or Dysportâ„¢.
5. The List is not a legislative instrument.
6. As at 28 May 2009, the H1N1 influenza 09 (Human Swine Influenza) virus is not an SSBA for the purposes of theÌýNational Health Security Act 2007.