National Health Security Act 2007 - Temporary Suspension of Provisions of Part 3

EXPLANATORY STATEMENT

Issued by the Minister for Health and Ageing

National Health Security Act 2007

Temporary suspension of provisions of Part 3

Part 3 of the National Health Security Act 2007 (the NHS Act) establishes controls for the biological agents that could be used as weapons.  Such an agent is known as a security sensitive biological agents (SSBA).  The Minister for Health and Ageing has established a List of SSBAs which is available at this link: http://www.health.gov.au/ssba#list.

Division 5A, Part 3 of that Act enables the Minister for Health and Ageing, following advice from relevant experts, to respond immediately and appropriately to the challenge of safeguarding public health and safety in the event of an SSBA-related disease outbreak.  The NHS Act enables the Minister to suspend certain existing regulatory requirements and specify new conditions to ensure that adequate controls are maintained. 

Background

The Australian Government is responding to a confirmed outbreak of cholera on Daru Island in the Western Province of Papua New Guinea (PNG). Some Queensland medical testing laboratories are assisting to test patient samples. Under the SSBA Regulatory Scheme Vibrio cholerae (serotypes O1 and O139 only) is an SSBA of high security concern (a Tier 2 agent). The V. cholerae isolated from this outbreak has been subtyped O1 and is therefore an SSBA under the regulatory scheme. 

The cholera outbreak is current and ongoing and also poses a threat to the health of Australians living in the Torres Strait. Rapid laboratory diagnosis and antimicrobial susceptibility testing is required to appropriately treat infected individuals and prevent further spread of the disease. The affected Queensland medical testing laboratories may be overburdened by the receipt of samples from PNG. Temporary suspension from the SSBA Regulatory Scheme will allow public health laboratories to focus on rapid diagnosis.

Timely laboratory processing, handling and transferring of clinical specimens and bacterial isolates is crucial to containment of the outbreak and prevention of further transmission.

Conditions

Subsection 60A(2) provides that the Minister may make a legislative instrument in relation to suspected SSBAs only if she is satisfied after considering relevant expert advice that there is a threat involving the agent to one or more of the following: the health or safety of people, the economy or the environment.  In addition, the Minister must be satisfied, after considering advice from the Secretary, that the making of the instrument would help reduce the threat and maintain adequate controls for the security of all SSBAs.

The Minister has obtained advice of the Commonwealth Chief Medical Officer and the Secretary and is satisfied that she has grounds to temporarily suspend the provisions in Part 3 of the NHS Act subject to the conditions specified in the attached instrument. In the context of responding urgently to this outbreak, no further consultations were able to be made.

Details of the temporary suspension of the provisions of Part 3 are set out in the Attachment.

This Instrument commences on registration on the Federal Register of Legislative Instruments.

This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

ATTACHMENT

DETAILS OF THE TEMPORARY SUSPENSION OF PROVISIONS OF PART 3

Commencement

1. This section provides that the instrument commences on registration.

Application

2. This section provides that this instrument applies to a biological agent that is suspected Vibrio cholerae O1 or confirmed Vibrio cholerae O1 in the geographic areas mentioned in the Schedule for a period of 20 business days from commencement of the instrument.

Advice of Chief Medical Officer and Secretary of Department of Health and Ageing

3. This section provides that the Minister for Health and Ageing is satisfied under subsection 60A (2) that:

(a) there is a threat involving suspected Vibrio cholerae O1 and confirmed Vibrio cholerae O1 to the health or safety of people in Australia, after considering advice from the Commonwealth Chief Medical Officer;  and

(b) the making of this legislative instrument would help to reduce the threat and maintain adequate controls for the security of all security-sensitive biological agents, after considering advice from the Secretary.

Suspension of application of certain provisions of Part 3 of the Act

4. This section provides that subject to the conditions specified in section 5, the provisions of the Act that do not apply are:

(a) for subsection 60A(1A) of the Act, all of the provisions of Division 4A of the Act, and section 38D of the Act so far as it relates to all provisions of the SSBA Standards that apply to an initial tester;  and

(b) for subsection 60A(1) of the Act, all of the provisions of Division 5 of the Act, and section 56 of the Act so far as it relates to all provisions of the SSBA Standards that apply to an entity that handles an SSBA at one or more facilities.

Conditions

This section sets out the conditions which will provide adequate security controls during the temporary suspension.

5. (1) This subsection relates to an agent that is a suspected Vibrio cholerae O1.  The provision will require an entity, within 10 business days after the end of the period mentioned in section 2, to send a consolidated report, to the address mentioned in section 6, that sets out:

(a) the numbers of occasions, if any, on which the entity starts to handle the agent;  and

(b) the numbers of occasions, if any, on which :

(i) arrangements were made for confirmatory testing[1] of the agent;  or

(ii) an agent was destroyed instead of having confirmatory testing;  or

(iii) an agent was transferred to another entity or laboratory for confirmatory testing;  or

(iv) an agent was destroyed after confirmatory testing determined the agent was a security-sensitive biological agent;  and

(c) the consolidated results of any confirmatory testing of agents.

(2)          This subsection relates to an agent that is confirmed as Vibrio cholerae O1. The provision requires an entity, within 10 business days after the end of the period mentioned in section 2, to send a consolidated report, to the address mentioned in section 6, that sets out the numbers of occasions, if any, on which the entity handled the agent.

(3)          This subsection relates to an agent that is suspected Vibrio cholerae O1 or confirmed Vibrio cholerae O1.  The provision requires an entity to retain records of the transport, results of confirmatory testing or destruction of the agent.

(4)          This subsection requires an entity, as far as practicable, to comply with those provisions of the SSBA Standards that relate to ensuring the security of the SSBA.

(5)          This subsection requires the Public Health Laboratory, Department of Health, Queensland to send all reports under this section to the Secretary within 20 business days after the end of the period mentioned in section 2, or such longer period as is specified by the Secretary in a written notice given to the Laboratory.

Address for reports under section 5

6. This section sets out the address for the reports required under section 5.  These reports are to be sent to the ‘Responsible Officer’ at ‘Public Health Laboratory, Department of Health, Queensland, 39 Kessels Road, Coopers Plains, Queensland 4108’ or by post to the ‘Responsible Officer’ at ‘PO Box 594, Archerfield, Queensland, 4108’.

The Schedule sets out the geographic locations to which the instrument applies.

SCHEDULE‑GEOGRAPHIC LOCATIONS

1. The local government area of the City of Brisbane.
2. The area of the State of Queensland north of a line extending across Queensland along the line of latitude 20 degrees South.[2]

[1]For the meaning of ‘confirmatory testing’ refer to section 38B of the NHS Act.

[2] This line of latitude is to the south of Townsville.