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Wednesday, 19 September 2012
Page: 11173


Ms PLIBERSEK (SydneyMinister for Health) (10:04): I move:

That this bill be now read a second time.

The National Health Security Amendment Bill 2012 amends the National Health Security Act 2007 to enhance Australia's obligations for securing certain biological agents such as anthrax and foot-and-mouth disease virus. These agents are called security sensitive biological agents (SSBAs).

The SSBA Regulatory Scheme includes stringent requirements relating to the notification of the type and location of SSBAs, along with standards that must be met by entities handling SSBAs. The standards relate to matters such as the secure handling, storage and transport of security sensitive biological agents along with personnel security requirements and risk management strategies.

Over the three years that the SSBA Regulatory Scheme has been operational, the government has worked closely with entities that handle SSBAs, along with other experts in the field, to ensure smooth administration of the legislation. A number of areas have been highlighted where improvements to the regulatory scheme might be made. The bill I am introducing today enhances the SSBA Regulatory Scheme in two important ways.

First, the proposed amendments provide a streamlined reporting scheme for entities, such as hospital diagnostic facilities, that are not registered under the SSBA Regulatory Scheme and only need to handle SSBAs for less than seven consecutive days, known as temporary handlings. These facilities do not register because they are unable to meet the SSBA standards for registered facilities and compliance would impose a large regulatory burden on them for such a short period of handling. The entities may be sent SSBAs to perform specific tests, for example antibiotic sensitivity testing, after which the SSBAs are sent to a registered facility or destroyed.

An entity that only handles SSBAs temporarily will be required to report the receipt of the SSBA and the purpose for handling the SSBA to the Secretary of the Department of Health and Ageing (the secretary), within two business days of starting to handle the SSBA. These entities will also need to report the disposal (that is the transfer to a registered facility or destruction of the SSBA) which must occur within seven days of receipt or a longer period approved by the secretary. Specific SSBA standards will apply to the entity during the handling period to ensure the security of the agent is maintained during the temporary handling.

Second, the amendments will allow the secretary to better manage potential security risks for entities undertaking emergency facility maintenance. Entities may be required to move the SSBA out of the registered facility and into a storage area or an unregistered facility when the emergency occurs and may have to do so in a very short time frame to ensure the SSBA remains viable.

Under these measures, entities will be required to inform the secretary of the emergency arrangements including security measures and proposed time frames for completion. In order to ensure the security of the SSBA is maintained during the emergency maintenance, the secretary will be able to impose conditions such as a direction to the entity not to handle the SSBA for any purpose other than to store the SSBA, or impose a condition that if the repairs are not completed within a certain time frame, the SSBA must be moved to a registered facility. The secretary will also be able to suspend some or all regulatory requirements including application of the relevant areas of the SSBA standards, during the time taken to undertake the maintenance appropriate to each unique emergency maintenance situation.

The amending bill also makes some amendments to improve the operation of the legislation and provide greater clarity for those working with SSBAs.

The first of these changes relates to the imposing of conditions to ensure the security of SSBAs is maintained in facilities required to undertake corrective actions following an inspection.

Under the SSBA Regulatory Scheme, a failure to comply with the standards is dealt with by the issue of notices for compliance which define the required corrective actions and the time frames within which the entity is to achieve compliance. It is intended that the secretary should be able to impose conditions during the period of noncompliance on the entity's SSBA handlings based on any risks presented by the noncompliance. These conditions will assist in the reduction of risk during the time provided for corrective action to be taken.

The conditions would be guided by the general principle that when imposing conditions, the entity's circumstances are considered and the level of security applied is proportionate to the level of risk presented by the handling of the SSBA. The kinds of conditions that will be imposed will relate to the broad security areas included in the SSBA standards of physical security, including storage, personnel security and information security.

Other measures in the bill deal with the clarification of reporting requirements by registered entities for biological agents suspected to be an SSBA. These measures will ensure that registered entities undertaking in-house confirmatory testing complete the reporting cycle for suspected SSBAs and report negative confirmatory testing results from the in-house tests. Measures will also ensure that the application of exemptions for certain entities are consistent between known and suspected SSBAs.

These changes have been the subject of consultation with agencies responsible for obtaining and assessing information about the risks and threats posed by biological agents (such as ASIO and other intelligence agencies), public and animal health laboratories, state and territory government agencies and other experts in SSBA.

I am confident that the bill addresses the issues identified during the operational period of the scheme and from stakeholder liaison, and ensures that we continue to deliver on our international commitments and the national imperative to actively improve our capacity to maintain adequate controls on security sensitive biological agents.

I commend the bill to the House.

Debate adjourned.