EXPLANATORY STATEMENT
Issued by the Minister for Health and Ageing
National Health Security Act 2007
National Health Security (SSBA Standards) Determination 2010
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 establish 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 National Health Security Act 2007 (NHS Act) on 13 November 2008.
Under the 2008 SSBA Standards, requirements relating to background checks, to be co-ordinated by AusCheck, were to commence on 1 July 2009. On 28 June 2009, the requirements for background checks were removed from the SSBA Standards as the necessary legislative changes to the NHS Act and the AusCheck Act 2007 (AusCheck Act) were not yet finalised.
The SSBA Standards were revised in 2009 and these Standards 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 necessary amendments to the NHS Act and the AusCheck Act in early 2010, Part 3 - Personnel of the SSBA Standards has been 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. The SSBA Standards recommend that persons handling Tier 2 SSBAs, accessing facilities where Tier 2 SSBAs are handled or accessing sensitive information relating to Tier 2 SSBAs undergo these checks.
Included in the requirements relating to the security status of individuals under Part 3 of the SSBA Standards, is a requirement for authorised persons to undergo an identity check and report any new convictions relating to Health Security Relevant Offences. Details of the Health Security Relevant Offences, used when assessing criminal history information, are set out at Appendix 1 of the SSBA Standards. The SSBA Standards also provide provisional authorisation arrangements for facilities registered at the time of commencement of these requirements and for new facilities undergoing the initial registration process.
On 3 June 2010, the Minister approved the revised SSBA Standards, dated 14 July 2010, for publication on the Department of Health and Ageing website (www.health.gov.au/ssba).
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, the Australian Capital Territory and the Northern Territory are also required to be consulted.
Subsection 35(5) provides that subsection 35(4) does not prevent the Minister from consulting any other person who the Minister considers may assist the Minister in developing a standard.
Consultations on the development of the draft SSBA Standards have occurred with persons with scientific or technical knowledge of SSBAs who are members of the Department’s advisory group: the Implementation Advisory and Consultative Committee (IACC).
The IACC is a committee chaired by the Department to provide advice on implementation of the regulatory scheme and comprises representatives of 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 of each State and the ACT and NT as well as representatives from the emergency services. AusCheck, who will co-ordinate the background checks, has been extensively consulted throughout the drafting process.
Draft Standards were released for public consultation on 1 April 2010 for a four week period and were placed on the Department of Health and Ageing website (http://www.health.gov.au/ssba). Over 90 comments from 11 individuals or organisations were received during the consultation period.
The Office of Best Practice Regulation (OBPR) advised that the revision of the SSBA Standards to include the requirements relating to background checking would not require a Regulation Impact Statement (RIS) or a Business Cost Calculator (BCC).
Details of the 2010 Determination are set out in the Attachment.
This Determination commences on 14 July 2010.
The 2010 Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
DETAILS OF THE NATIONAL HEALTH SECURITY (SSBA STANDARDS) DETERMINATION 2010
1. Name of Determination
This section provides for the correct name of this Determination as being the National Health Security (SSBA Standards) Determination 2010.
2. Commencement
This section provides that this Determination commences on 14 July 2010.
3. Definition
This section sets out definitions of terms used in the Determination.
4. Determination
The effect of section 4 is to incorporate, by reference, the requirements set out in the SBBA Standards document dated 14 July 2010.
5. Revocation
This section revokes the National Health Security (SBBA Standards) Determination 2009.