EXPLANATORY STATEMENT
Issued by the Minister for Health and Ageing
National Health Security Act 2007
National Health Security (SSBA Standards) Determination 2008
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 SSBAs and the transport of SSBAs. Section 56 of the NHS Act requires entities that handle SSBAs to comply with the SSBA Standards.
Background
In December 2002, COAG agreed to a national review of the regulation, reporting and security around the storage, sale and handling of hazardous materials. The review has been conducted in four parts covering ammonium nitrate, radiological, biological and chemical material.
The COAG Report on the Regulation and Control of Biological Agents (COAG Report) recommended establishing a national regulatory scheme to minimise the security risks posed by biological agents that may be used for terrorist purposes. The legislative response to the COAG Report is set out in Part 3 of the NHS Act.
The objective of Part 3 of the NHS Act is to give effect to Australia’s obligations to establish controls for the security of biological agents that could be used as weapons. To achieve this, Part 3 provides for:
- the collection, and recording on a national register, information about the nature and location of SSBAs legitimately handled by entities and facilities in Australia;
- requirements to be complied with for the secure handling of SSBAs (including standards);
- monitoring of compliance with reporting and handling requirements through an inspection program;
- inspector powers; and
- penalties for non-compliance.
The regulatory scheme is built around a two-tiered List of SSBAs (the List) established by the Minister under subsection 31(1) of the NHS Act. The List is derived using intelligence information and an analysis of the impact and feasibility of the use of these agents in a terrorist act.
It is intended that Tier 1 agents will be regulated from 2009 and Tier 2 agents will be regulated from 2010.
Section 35 of the NHS Act provides that the Minister may, by legislative instrument, determine standards (SSBA Standards) relating to security-sensitive biological agents. The purpose of the National Health Security (SSBA Standards) Determination 2008 (the Determination) is for the Minister to determine the SSBA Standards under section 35 of the NHS Act. The Minister’s Determination incorporates, by reference, the document referred to as the Security-sensitive Biological Agent (SSBA) Standards dated 30 September 2008, published by the Commonwealth and that 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 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 SSBA Standards have a number of areas where the requirements for agents listed as Tier 1 (agents of the highest security concern) or Tier 2 (agents of high security concern) differ. This is to reflect the difference in the nature of the two tiers as noted in the COAG Report.
Consultation
Subsection 35(4) provides for the consultations of certain persons that must take place in developing the Standards. Those persons are persons with scientific or technical knowledge in relation to the security of biological agents; and the States, the Australian Capital Territory and the Northern Territory.
Subsection 35(5) provides that that provision 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 groups: the Implementation Advisory and Consultative Committee (IACC) and the Regulation and Standards Working Group (RSWG).
The IACC is a committee chaired by the Department to provide advice on implementation of the regulatory scheme and comprises representatives of twelve government agencies including the Australian Chemical, Biological, Radiological and Nuclear Data Centre and the Australian Security Intelligence Organisation. Members of the RSWG are a group of technical experts who represent the Animal Health Committee, the Office of the Gene Technology Regulator, Department of Foreign Affairs and Trade, and the Public Health Laboratory Network.
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.
Draft Standards were released for public consultations on 12 June 2008 and placed on the Department of Health and Ageing website (http://www.health.gov.au/ssba). Comment was also sought from stakeholders identified in a survey conducted between February and July 2008 by the Department of Health and Ageing.
During June and July 2008, consultation workshops were held in each capital city (except Darwin and Hobart) with the consultation period closing on 1 August 2008. Attendees at the workshops included laboratories in the areas of animal health, defence, diagnostics, public health and research.
Over 930 comments from 26 individuals or organisations were received during the consultation period.
Road shows for the SSBA Regulatory Scheme were conducted in all capital cities in August and September 2008 to further consult affected stakeholders.
The Office of Best Practice Regulation (OBPR) advised that a Regulation Impact Statement (RIS) would not be required for the SSBA Standards. The OBPR advised that a Business Cost Calculator (BCC) assessment would be sufficient as further regulatory impact analysis of the costs to business.
Details of the Determination are set out in Attachment A.
The Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT A
DETAILS OF THE NATIONAL HEALTH SECURITY (SSBA STANDARDS) 2008
1. Name of Determination
This section provides that this Determination is the National Health Security (SSBA Standards) Determination 2008.
2. Commencement
This section provides that this Determination commences immediately after the commencement of Part 3 of the NHS Act. Part 3 of that Act provides a regulatory scheme for handling SSBAs.
3. Definition
This section provides the definitions of:
Act means the National Health Security Act 2007.
SSBA Standards means the Security-sensitive Biological Agent (SSBA) Standards, dated 30 September 2008, published by the Commonwealth.
4. Determination
Subsection 4(1) provides that the SSBA Standards are determined for subsection 35(1) of the Act.
Subsection 4(2) provides for when this Determination comes into effect for clauses 1 and 2 of the SSBA Standards and the remainder the SSBA Standards. Clauses 1 and 2 of the SSBA Standards come into effect immediately after the commencement of Part 3 of the NHS Act and the remainder of the Standards come into effect on 1 July 2009.
Clause 1 of the SSBA Standards relates to the scope of and definitions used in the document. Clause 2 refers to requirements related to Risk and Incident Management. The phased in commencement of the SSBA Standards is to respond to concerns that full compliance with the SSBA Standards by January 2009 was not feasible.
Clauses 1 and 2 commence first because it is important for entities to undertake a risk assessment and to formulate a risk management plan as they are integral to the understanding of the risks involved and will determine the operation of the rest of the SSBA Standards. Entities that report after 31 January 2009 will need to be compliant with the SSBA Standards.
The risk mitigation strategies determined under the risk management plan will take time to implement and entities will be given until 1 July 2009 to comply with the requirements in clauses 3 to 9 of the SSBA Standards. Entities that report after 1 July 2009 will need to be compliant with the full SSBA Standards.