EXPLANATORY STATEMENT
Issued by the Minister for Health and Ageing
National Health Security Act 2007
National Health Security (SSBA Standards) Amendment Determination 2009 (No. 1)
Background
Subsection 35(1) of the National Health Security Act 2007 (NHS Act), provides that the Minister may, by legislative instrument, determine standards (SSBA Standards) relating to security-sensitive biological agents (SSBAs).
The SSBA Standards 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.
The National Health Security (SSBA Standards) Determination 2008 (the Principal Determination) was made by the Minister on 13 November 2008. Section 3 of the Principal Determination provides that SSBA Standards means the Security-sensitive Biological Agent (SSBA) Standards dated 30 September 2008, published by the Commonwealth. The SSBA Standards can be found on the Department’s website at http://www.health.gov.au/ssba.
The Principal Determination provides that Parts 1 and 2 of the SSBA Standards came into effect immediately after the commencement of Part 3 of the NHS Act. Part 3 of the SSBA Standards commences on 1 July 2009. The objective of Part 3 of the SSBA Standards is to ensure that personnel management systems are in place to implement biosecurity for SSBAs and related sensitive information.
Clauses 3.3 (Authorised persons) and 3.4 (Recruitment) of the SSBA Standards require, among other things, that persons handling SSBAs undergo background checking consisting of a National Criminal History Check and a Politically Motivated Violence Check.
Purpose
The National Health Security (SSBA Standards) Amendment Determination 2009 (No. 1) (the Determination) amends the Principal Determination by adding a new Schedule 1 to the Principal Determination. Schedule 1 modifies the SSBA Standards by substituting new clauses 3.3 and 3.4, including the commentaries. In effect, the modifications to clauses 3.3 and 3.4 remove the requirement for persons handling Tier 1 SSBAs or related sensitive information to undergo background checking.
A background checking process consistent with national security measures has been delayed because supporting legislation has not been enacted. Following passage of the required legislation, new SSBA Standards will be determined to require background checking of persons handling SSBAs or related sensitive information.
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.
Consultation
It was unnecessary to consult with stakeholders on making the Determination as the Determination does not adversely impact anyone and is clearly of benefit to persons who would otherwise be subject to an obligation with which they were unable to comply, or who were unsure of the need to comply. Stakeholders will be notified by the Department once the Determination is made.
ATTACHMENT A
DETAILS OF THE NATIONAL HEALTH SECURITY (SSBA STANDARDS) AMENDMENT DETERMINATION 2009 (No. 1)
1. Name of Determination
This section provides that this Determination is the National Health Security (SSBA Standards) Amendment Determination 2009 (No. 1).
2. Commencement
This section provides that this Determination commences on 1 July 2009.
3. Amendment of National Health Security (SSBA Standards) Determination 2008
This section provides that Schedule 1 amends the National Health Security (SSBA Standards) Determination 2008 (the Principal Determination).
Schedule 1 Amendments
Item 1
This item amends subsection 4(1) of the Principal Determination by omitting the words ‘SSBA Standards’ and substituting the words ‘SSBA Standards, as modified by Schedule 1’. The effect of this amendment is that the SSBA Standards are modified by the clauses in the new Schedule 1 of the Principal Determination that is inserted by item 2 of this Determination.
Item 2
This item inserts Schedule 1 into the Principal Determination which modifies the SSBA Standards.
Clause 1 of the Schedule substitutes a new clause 3.3 in the SSBA Standards, including the commentary. The new clause 3.3 omits the requirement for authorised persons handling SSBAs or sensitive information to undergo background checking consisting of a National Criminal History Check and a Politically Motivated Violence Check.
Clause 2 of the Schedule substitutes a new clause 3.4 in the SSBA Standards, including the commentary. The new clause 3.4 omits the requirement for persons recruited to handle Tier 1 SSBAs or sensitive information to undergo background checking consisting of a National Criminal History Check and a Politically Motivated Violence Check.
Overview
The National Health Security (SSBA Standards) Amendment Determination 2009 (No. 1) was introduced to amend the National Health Security (SSBA Standards) Determination 2008, which itself was made under the National Health Security Act 2007. This Act was enacted to address the need for stringent security measures surrounding security-sensitive biological agents (SSBAs), including their storage, the security status of individuals handling them, and their transport. The Amendment Determination was made by the Minister for Health and Ageing to temporarily modify the SSBA Standards due to delays in the enactment of supporting legislation for background checks. Consequently, the Amendment Determination removes the requirement for background checking for persons handling Tier 1 SSBAs or related sensitive information, effective from 1 July 2009. This temporary measure aims to ensure compliance with SSBA handling protocols without imposing unnecessary burdens on individuals until the necessary legislative framework is established.
Scope and Application
The National Health Security (SSBA Standards) Amendment Determination 2009 (No. 1) amends the existing National Health Security (SSBA Standards) Determination 2008, modifying the security-sensitive biological agent (SSBA) standards as prescribed under the National Health Security Act 2007. The amendment applies to all entities that handle SSBAs within the Commonwealth jurisdiction, ensuring they comply with the updated standards. The primary change introduced by this determination involves the removal of the requirement for persons handling Tier 1 SSBAs or related sensitive information to undergo background checking, including a National Criminal History Check and a Politically Motivated Violence Check. This amendment is a temporary measure due to delays in the enactment of supporting legislation for the background checking process. Once the necessary legislation is passed, new SSBA standards will be determined to reinstate the background checking requirement. The amendment aims to ensure that entities handling SSBAs can continue to operate without undue burden while the background checking framework is being established.
Key Provisions
The National Health Security (SSBA Standards) Amendment Determination 2009 (No. 1) amends the existing National Health Security (SSBA Standards) Determination 2008 by introducing a new Schedule 1, which modifies the Security-sensitive Biological Agent (SSBA) Standards. Specifically, the new Schedule 1 removes the requirement for authorised persons handling SSBAs or related sensitive information to undergo background checking. This change is detailed in the new clauses 3.3 and 3.4, which replace the existing clauses in the SSBA Standards. The objective behind these changes is to address the delay in implementing a background checking process consistent with national security measures, due to the absence of supporting legislation.
The Act imposes specific obligations on entities handling SSBAs, as outlined in section 56 of the National Health Security Act 2007 (NHS Act). These obligations include compliance with the SSBA Standards, which detail requirements for the storage, security status of individuals handling SSBAs, and the transport of these agents. Under the Principal Determination, entities are required to implement personnel management systems to ensure biosecurity for SSBAs and related sensitive information. This involves ensuring that all authorised persons undergo necessary background checks, which typically include a National Criminal History Check and a Politically Motivated Violence Check. The new Schedule 1, however, modifies these requirements by omitting the necessity for background checking for certain categories of SSBAs and sensitive information.
The National Health Security (SSBA Standards) Amendment Determination 2009 (No. 1) does not introduce new offences or penalties but modifies existing standards. Any entity that fails to comply with the amended SSBA Standards could face legal consequences under the NHS Act. Non-compliance with the SSBA Standards can lead to enforcement actions by the relevant authorities, which may include fines or other penalties as determined by the legislation. The maximum penalties for breaches of the NHS Act are not specified in the Determination but can be severe, depending on the nature and severity of the breach.
Overall, the Determination is intended to ensure that entities handling SSBAs can continue to operate without the immediate requirement for background checks, while still maintaining a high level of biosecurity. The changes are temporary, pending the enactment of supporting legislation that will reinstate the background checking requirements. The Minister for Health and Ageing did not consider it necessary to consult with stakeholders as the Determination does not adversely impact anyone and provides relief to those who might otherwise be unable to comply with the previous standards.