EXPLANATORY STATEMENT
Issued by the Minister for Health and Ageing
National Health Security Act 2007
National Health Security (SSBA Standards) Determination 2009
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 including their storage, the security status of individuals who handle or dispose of SSBAs and the transport of SSBAs. Section 56 of the NHS Act requires entities that handle SSBAs to comply with the SSBA Standards.
Background
The National Health Security (SSBA Standards) Determination 2008 (the 2008 Determination) was made by the Minister for Health and Ageing under section 35 of the National Health Security Act 2007 (NHS Act) and was entered on the Federal Register of Legislative Instruments on 24 November 2008. The 2008 Determination determined the document entitled “Security-sensitive Biological Agent (SSBA) Standards”, dated 30 September 2008 as constituting the SSBA Standards. Following the commencement of the SSBA regulatory scheme in January 2009 and the receipt of feedback from the regulated community, the standards document referred to in the 2008 Determination has been revised to improve clarity and to provide requirements about agents that are suspected to be SSBAs.
During the implementation of the SSBA regulatory scheme, it was determined that changes, requiring amendments to the NHS Act, were needed. These changes were included in the National Health Security Amendment Bill 2009 (NHS Bill). The NHS Bill was passed during the 2009 spring sittings of Parliament and received Royal Assent on 7 October 2009.
One of these amendments in the NHS Bill is that the Minister is to be permitted to determine standards about the handling of biological agents that are suspected of being SSBAs. The amendments allow these standards to set out requirements about the storage, access, disposal and transport of these agents while awaiting confirmatory testing results.
The purpose of the National Health Security (SSBA Standards) Determination 2009 (the 2009 Determination) is to revoke and replace the 2008 Determination to take account of revised and new requirements in the SSBA Standards consequential to changes in the National Health Security Amendment Act 2009. The 2009 Determination incorporates, by reference, the document referred to as the Security-sensitive Biological Agent (SSBA) Standards dated 1 October 2009, published by the Commonwealth and which can be found on the Department’s website http://www.health.gov.au/ssba.
The SSBA Standards set out minimum requirements relating to physical security, information management, decontamination and inactivation, disposal and transport of SSBAs, and the security status of individuals handling confirmed SSBAs. They include specific directions for dealing with biosecurity risks and establish a systematic approach to the management of the
security of SSBA. The SSBA Standards are comprised of normative requirements that are mandatory and informative statements to assist in meeting the normative statements.
The Minister has established a list of biological agents under Part 3 of the National Health Security Act 2007 that she considers to be of security concern to Australia. This list is the List of Security-sensitive Biological Agents (the List of SSBA). The inclusion of agents on the List is derived from the Council of Australian Governments (COAG) Report on the Regulation and Control of Biological Agents, which developed the COAG Biological Agents list (the COAG list) in November 2006. Tier 1 agents pose the greatest risk to Australia, while Tier 2 agents are rated less likely to pose a security risk. Tier 1 SSBAs have been regulated since 31 January 2009 and Tier 2 SSBAs will be regulated from January 2010.
The SSBA Standards contain differing requirements for Tier 1 and Tier 2 SSBAs. This is to reflect the security concerns surrounding each tier, with Tier 1 SSBAs having greater security requirements than Tier 2 SSBAs.
In addition to the requirements for handling confirmed SSBAs, the SSBA Standards also set out the requirements for handling biological agents that are suspected of being SSBAs. Entities that have a suspected SSBA must either destroy the agent or transfer a sample for confirmatory testing within two business days of the initial suspicion of the agent being an SSBA. Entities that form the initial suspicion are referred to as the initial tester.
Compliance with the suspected SSBA Standards begins when the initial tester forms a reasonable suspicion, on the basis of testing in the laboratory, that the biological agent is an SSBA. The entity must then undertake confirmatory testing, either in-house if possible or by sending the agent to a facility able to undertake these tests. Compliance with the suspected SSBA Standards will end when the initial tester receives the results of the confirmatory test or upon the complete destruction of the agent if confirmatory testing is not undertaken.
Part 9 of the SSBA Standards sets out the handling requirements for suspected SSBAs. These include restriction of access, storage, transport, destruction, waste disposal and record keeping requirements for suspected SSBAs. If an agent is subsequently confirmed as an SSBA, entities will then need to comply with the requirements of the Act, Regulations and Standards for confirmed SSBAs.
Consultation
Subsection 35(4) provides that certain persons must be consulted prior to the Minister determining a standard. Those persons 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 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.
Draft Standards were released for public consultation on 3 August 2009 and placed on the Department of Health and Ageing website (http://www.health.gov.au/ssba).
Over 120 comments from 16 individuals or organisations were received during the consultation period.
Road shows for the SSBA Regulatory Scheme were conducted in all Australian capital cities in July and August 2009 and included an invitation to comment on the proposed changes to the SSBA Standards.
The Office of Best Practice Regulation (OBPR) advised that the revision of the SSBA Standards and the incorporation of new standards for handling suspected SSBAs would not require a Regulation Impact Statement (RIS) or a Business Cost Calculator (BCC).
Details of the 2009 Determination are set out in the Attachment.
The 2009 Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
DETAILS OF THE NATIONAL HEALTH SECURITY (SSBA STANDARDS) 2009
1. Name of Determination
This section provides that this Determination is the National Health Security (SSBA Standards) Determination 2009.
2. Commencement
This section provides that this Determination commences on 31 January 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 1 October 2009.
5. Revocation
This section revokes the National Health Security (SBBA Standards) Determination 2008.