Security Sensitive Biological Agents
Regulation of Security Sensitive Biological Agents (SSBA) has been implemented as a result of the Council of Australian Governments (COAG) national review of hazardous materials. The COAG review consisted of four parts covering: ammonium nitrate; radiological material; hazardous chemicals and harmful biological agents. The first recommendation in the COAG endorsed review of harmful biological agents was to establish a two-tiered list of security sensitive biological agents (SSBA's) for regulation.
In accordance with Part 3 of the National Health Security Act 2007, a regulatory scheme has been implemented by the Office of Health Protection, Department of Health and Ageing for the regulation of security sensitive biological agents. The aim is "to give effect to Australia's obligations to establish controls for the security of certain biological agents that could be used as weapons."
The regulatory scheme is implemented to improve the security of biological agents of security concern in Australia. It builds on Australia's obligations under the Biological and Toxins Weapons Convention and UN Security Council Resolution 1540.
Regulation of SSBAs
Agents that are considered to be of security concern to Australia are regulated by inclusion on the List of Security Sensitive Biological Agents (the List of SSBAs). Regulation of the Tier 1 SSBAs included on the List commenced in January 2009 and regulation of the Tier 2 SSBAs commenced 31 January 2010.
- The National Health Security Act 2007 legislates 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.
- The National Health Security Regulations 2008 (NHS Regulations) support the Act by providing operational detail about the SSBA Regulatory Scheme.
If you intend to handle any agent on the List of SSBAs you must register them by contacting the Office of Research Ethics, Compliance & Integrity.
|Tier 1 SSBA||Tier 2 SSBA|
|Abrin [5 mg]||African swine fever virus|
|Bacillus anthracis (Anthrax-virulent strains)||Capripoxvirus (Sheep pox virus and Goat pox virus)|
|Botulinum toxin [0.5 mg]||Classical swine fever virus|
|Ebolavirus||Clostridium botulinum (Botulism; toxin-producing strains)|
|Foot-and-mouth disease virus||Francisella tularensis (Tularemia)|
|Highly pathogenic influenza virus, infecting humans 6||Lumpy skin disease virus|
|Ricin [5 mg]||Yellow fever virus (non-vaccine strains)|
|Variola virus (Smallpox)|
|Yersinia pestis (Plague)|
- Tier 1 agents pose the greatest risk to Australia, while Tier 2 agents are rated less likely to pose a security risk.
- The agents above only refer to infectious, viable and pathogenic organisms or active toxins.
- 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.
- Botulinum toxin does not refer to a form approved for therapeutic use under the Therapeutic Goods Act 1989. For example, the forms of Botulinum toxin approved for therapeutic use and known under their commercial names Botox™ or Dysport™.
- The List is not a legislative instrument.
- As at 28 May 2009, the H1N1 influenza 09 (Human Swine Influenza) virus is not an SSBA for the purposes of the National Health Security Act 2007.
Standards for the handling, storage, disposal and transport of security-sensitive biological agents and suspected security-sensitive biological agents have been issued under Section 35 of the National Health Security Act 2007.
The SSBA guidelines have been developed to support the SSBA Regulatory Scheme.
The guidelines currently include information about the following topics:
- Defining Loss, Theft and Accidental Release of SSBAs
- Entities and Facilities
- Handling a Person or Animal, or Samples from a Person or Animal, Affected by an SSBA
- Indicators of Suspicious Behaviour in Laboratories Handling SSBA
- Non-Registered Facility Reporting and Requirements
- Reporting to Law Enforcement or the National Security Hotline
- Registered Facility Reporting Requirements
- SSBA Regulatory Scheme Monitoring Inspections
- SSBA Toxins
- SSBAs and Other Regulatory Schemes
- SSBAs in the Natural Environment
- Transporting SSBAs and Suspected SSBAs
- Toxin levels in environmental and clinical samples
SSBA fact sheets
In addition, SSBA fact sheets are available to support the education and awareness of the SSBA Regulatory Scheme and provide information to stakeholders on topics of particular interest. There are currently Fact Sheets on the following topics:
- About us (Office of Health Protection, Department of Health and Ageing)
- Changes to the National Health Security Legislation
- Domestic legislation
- Emergency disease situations
- Emergency situations
- Information security
- International conventions and agreements
- Legislative framework
- List of Security Sensitive Biological Agents
- Monitoring and compliance
- National health security checks
- Top management
- Upgrading a facility from Tier 2 to Tier 1 SSBAs
The SSBA Regulatory Scheme requires entities and facilities to report to the Department of Health and Ageing details of reportable events in relation to the handling of SSBAs.
Contact the Office of Research Ethics, Compliance & Integrity if you require further information about SSBA reporting.
Feedback on guidelines & fact sheets
The SSBA guidelines and fact sheets have been developed to support the SSBA Regulatory Scheme. Stakeholders are welcome to suggest areas of interest that may warrant the development of further items.
Any suggestions for the SSBA guidelines or fact sheet topics should also be emailed to the Office of Research Ethics, Compliance & Integrity.