EXPLANATORY STATEMENT
Issued by the Minister for Health and Ageing
National Health Security Act 2007
National Health Security (SSBA Standards) Determination 2011
Subsection 35(1) of the National Health Security Act 2007 (the NHS Act) provides that the Minister may, by legislative instrument, determine standards (SSBA Standards) relating to security-sensitive biological agents (SSBAs).
A standard may set out requirements relating to SSBAs and biological agents suspected of being SSBAs. Requirements include specific directions for dealing with biosecurity risks and the establishment of a systematic approach to the management of the security of SSBAs and suspected SSBAs. The SSBA Standards are comprised of normative requirements that are mandatory and informative statements to assist in meeting the normative requirements. Section 56 of the NHS Act requires entities that handle SSBAs comply with the SSBA Standards. If an entity fails to comply with a direction to dispose of SSBAs as a result of non-compliance with the Standards, it may involve the commission of an offence under subsection 58(1) of the NHS Act.
The list of biological agents of security concern (the List of Security-sensitive Biological Agents) has been established by the Minister under Part 3 of the NHS Act. Tier 1 agents pose the highest risk to Australia, while Tier 2 agents pose a high risk. Tier 1 SSBAs have been regulated since 31 January 2009, with Tier 2 SSBAs and suspected SSBAs regulated from 31 January 2010. To reflect these risks, the SSBA Standards contains differing requirements for the handling of Tier 1 and Tier 2 SSBAs.
Background
The National Health Security (SSBA Standards) Determination 2008 (the 2008 Determination) incorporated the document entitled “Security-sensitive Biological Agent (SSBA) Standards”, dated 30 September 2008 as constituting the SSBA Standards. The 2008 determination was made by the Minister for Health and Ageing under section 35 of the NHS Act on 13 November 2008.
The SSBA Standards were revised in 2009 and were incorporated by reference into the National Health Security (SSBA Standards) Determination 2009 on 4 December 2009. These Standards came into force on 31 January 2010.
Following amendments to the NHS Act and the AusCheck Act 2007 in early 2010, ‘Part 3 – Personnel’ of the SSBA Standards was updated to prescribe requirements regarding the security status of individuals who will handle Tier 1 SSBAs, access facilities where Tier 1 SSBAs are handled or access sensitive information relating to Tier 1 SSBAs. These Standards came into force on 14 July 2010.
The Standards have been revised to incorporate feedback from the SSBA Regulatory Scheme inspections, the regulated community and other interested stakeholders. These revisions include the addition of two new parts to the Standards. The first new part (Part 4A) provides further guidance on storage requirements, inventory and procedures for handling working cultures. Part 4A also provides more differentiation for the storage of Tier 1 and Tier 2 SSBAs. The second new part (Part 9A) continues the handling requirements for biological agents previously suspected of being SSBAs (Part 9 of the Standards) following receipt of a positive confirmatory test. This new part has been added to ensure the secure handing of an agent that was a suspected SSBA, and is now confirmed as an SSBA, until the agent is disposed of by being either destroyed or transferred in its entirety, within the timeframes specified under the NHS Act.
Consultation
Subsection 35(4) provides that certain persons must be consulted prior to the Minister determining a standard. These are persons with scientific or technical knowledge in relation to security concerns about biological agents. The states and territories are also required to be consulted.
Subsection 35(5) allows the Minister to consult any other person who the Minister considers may assist her in developing a standard.
Consultations with persons with scientific or technical knowledge of SSBAs have occurred through the Implementation Advisory and Consultative Committee (IACC). The IACC is a committee chaired by the Department of Health and Ageing to provide advice on implementation of the SSBA Regulatory Scheme and comprises of representatives from 12 government agencies, including the Australian Chemical, Biological, Radiological and Nuclear Data Centre and the Australian Security Intelligence Organisation.
Consultations have also occurred with the National Counter Terrorism Committee’s Chemical, Biological, Radiological and Nuclear (CBRN) Security Sub-Committee, which includes representatives from each state and territory as well as representatives from the emergency services. AusCheck, the agency responsible for co-coordinating National Health Security (NHS) checks, was also consulted throughout the drafting process.
The draft Standards were released for public consultation on 18 November 2010 for an eight week period and were available on the Department of Health and Ageing’s website (http://www.health.gov.au/ssba). Over 50 comments from 10 individuals or organisations were received during the consultation period and comments were incorporated where appropriate.
The Office of Best Practice Regulation (OPBR) was consulted regarding the provision of a Regulation Impact Statement (RIS) or a Business Cost Calculator (BCC). The OBPR advised that the project was assessed as having low to no impact on business, and as such a RIS or BCC was not required.
Details of the 2011 Determination are set out in the Attachment.
The 2011 Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
DETAILS OF THE NATIONAL HEALTH SECURITY (SSBA STANDARDS) DETERMINATION 2011
1. Name of Determination
This section provides for the correct name of this Determination as being the National Health Security (SSBA Standards) Determination 2011.
2. Commencement
This section provides that this Determination commences on 1 July 2011.
3. Revocation
This section revokes the National Health Security (SBBA Standards) Determination 2010.
4. Definition
This section sets out definitions of terms used in the Determination.
5. Determination
The effect of section 4 is to incorporate, by reference, the requirements set out in the SBBA Standards document dated July 2011.