NATIONAL HEALTH SECURITY BILL 2007 Explanatory Memorandum

Commonwealth of Australia Explanatory Memoranda

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NATIONAL HEALTH SECURITY BILL 2007

2004-2005-2006-2007 THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA HOUSE OF REPRESENTATIVES NATIONAL HEALTH SECURITY BILL 2007 EXPLANATORY MEMORANDUM (Circulated by authority of the Minister for Health and Ageing, the Hon Tony Abbott, MP)

NATIONAL HEALTH SECURITY BILL 2007 OUTLINE The main purpose of the National Health Security Bill 2007 (the Bill) is to: · provide for the exchange of public health surveillance information to enhance the identification of, and quick response to, public health events of national significance including certain communicable disease outbreaks, certain releases of a chemical, biological or radiological agent, other public health risks, or overseas mass casualties; · provide for the sharing of information with the World Health Organization (WHO) and countries affected by an event relating to public health, or an overseas mass casualty; · give effect to the International Health Regulations 2005 (IHR) which came into force on 15 June 2007. The IHR aim to prevent, protect against, control and provide a public health response to the international spread of disease in ways which avoid unnecessary interference with international traffic and trade; and · establish a scheme for the national registration and regulation of entities handling security-sensitive biological agents (SSBA). FINANCIAL IMPACT STATEMENT The 2004-05 Federal Budget provided $1.6 million over three years to develop and introduce new national health security legislation to improve the Commonwealth's capability to protect the health of the nation, and to respond to naturally occurring epidemics or terrorist attacks involving chemical, biological and radiological agents. A further $1.8 million was provided over four years to develop a national register of laboratories that use or store high-risk human pathogens and toxins. 1

REGULATION IMPACT STATEMENT The Office of Best Practice Regulation (OBPR) advised on 1 November 2006 that a Regulatory Impact Statement (RIS) was not required for the surveillance component of the Bill (Part 2) as the proposed legislation did not substantially alter existing health surveillance arrangements (RIS ID 8672). A RIS was developed for the component of the Bill dealing with regulation of laboratories handling SSBA (Part 3 of this Bill). This RIS was prepared by the Department of the Prime Minister and Cabinet as part of the development of the Report on the Regulation and Control of Biological Agents (the COAG Report). The RIS forms part of the COAG Report (Sections 8.1-8.3), which considered four options: · maintaining the status quo for the security of biological agents; · industry self regulation to a standard issued by the Australian Government; · industry co-regulation to a standard issued by the Australian Government and overseen by an industry compliance committee; and · mandatory national regulation by the Australian Government. The COAG Report is available at: http://www.coag.gov.au/meetings/130407/index.htm Further information is available from the Department of Health and Ageing at: COAG.Review.Biological.Agents@health.gov.au The COAG Report provided an analysis of the costs, benefits and outcomes for each option and recommended that the mandatory national regulation option provided the lowest likelihood of failure and the most effective and efficient means of minimising the security risks posed by SSBA. This Bill now provides the framework to implement the recommended regulatory option of mandatory national regulation. The OBPR advised on 1 November 2006 that the COAG Report satisfied COAG's requirements for regulatory impact analysis (RIS ID 3885). The OBPR noted that: · the RIS guidelines had been followed; · the level of analysis was commensurate with the potential economic and social impact of the proposals; and · alternatives to regulation had been adequately considered. The COAG Report acknowledged that a range of issues were better addressed during implementation of the scheme. A phased implementation, with the regulatory scheme coming into effect on 1 January 2009, will enable the Department of Health and Ageing to work with the sector to minimise the regulatory burden. Further regulatory impact analysis will be undertaken as the arrangements are implemented as appropriate. 2

NATIONAL HEALTH SECURITY BILL 2007 NOTES ON CLAUSES PART 1 - PRELIMINARY Clause 1 - Short title This is a formal provision that specifies the short title of the Act as the National Health Security Act 2007. Clause 2 - Commencement This clause describes when the various provisions in the Bill will commence. The regulatory arrangements will be `phased in', with particular provisions commencing at different times: · clauses 1- 5 (the preliminary provisions) and Part 4 (the regulation making power) will commence on Royal Assent; · Part 2 (the provisions relating to public health surveillance) will come into effect on a day to be fixed by Proclamation, but not later than 6 months after Royal Assent; · Part 3 (the provisions relating to the regulation of entities handling SSBA) will come into effect on a day to be fixed by Proclamation, but not later than 18 months after Royal Assent. The scheme for regulation of SSBA is being phased-in over an extended period to enable consultation with stakeholders in the development of standards, procedures and administrative arrangements. It is envisaged that an advisory group supported by working groups will be established to facilitate consultation before Part 3 of the Bill commences, and to support the ongoing operation of the scheme. These groups will include representatives of Commonwealth, State and Territory government departments and agencies responsible for health, transport, security, science, agriculture and industry. They will also comprise industry representatives, as well as scientists and other technical experts from the public and private sectors (including academia) with expertise in microbiology and pathology. Clause 3 - Definitions This clause contains a very wide range of definitions that are relied on in other provisions throughout the Bill. Some important definitions that warrant detailed explanation include the following. Definitions relevant to public health surveillance (Part 2 of the Bill) International Health Regulations One of the reasons for developing this legislation is to implement Australia's commitments under the IHR. The IHR are defined to mean the International Health Regulations 2005, done at Geneva on 23 May 2005, as in force for 3

Australia from time to time. The definition picks up the regulations as in force from time to time because matters such as the List of diseases at Annex 2 of the IHR may change, for example, to add emerging diseases. The IHR anticipate that such changes will be made and provide for member states to `reserve' from such amendments, consistent with the accession process for the initial treaty. The definition addresses the possibility that Australia could `reserve' from an amendment the meaning of IHR would then exclude the `reserved' provision. Australia did not, however, `reserve' from any provision of the initial treaty. The immediate application in Australia of amendments to the IHR will facilitate swift compliance, which may be important for the management of a public health event. Details of the IHR are on the DFAT treaty website (www.dfat.gov.au/treaties). Currently, the text of the IHR is accessible through the World Health Organisation website (www.who.int/csr/ihr/en/). It will be added to Australian Treaties Library on the AustLII Internet site (www.austlii.edu.au) in September 2007. disease A number of definitions and provisions used in the Bill refer to diseases (for example, the Bill provides for sharing of information where the occurrence of a disease is unusual or unexpected and has a high potential to spread). `Disease' has been defined in clause 3 of the Bill to mean an illness or medical condition (other than an injury), irrespective of origin or source, that presents or could present significant harm to humans. It should be noted that the reference to `significant harm to humans', does not necessarily mean significant harm to one human. It may be that although the illness or condition is not substantially debilitating for each individual affected, it presents significant harm precisely because it is affecting, or has the potential to affect, many people. event Like the word `disease', `event' is relied on in other definitions, such as the definitions for `overseas mass casualty' and `public health event of national significance'. `Event' is defined to mean an occurrence of disease, injury or death, or an occurrence, including the release of a chemical, biological or radiological agent that creates the potential for disease, injury or death. public health event of national significance The Bill enables the sharing of information in order to enhance the ability of Australia to identify, monitor and respond quickly to public health events of national significance. The Bill defines such events to mean: · one or more cases of a disease listed on the National Notifiable Disease List (clauses 11 and 12 of the Bill deal with the establishment and variation of the National Notifiable Disease List); · an urgent event This is defined in the Bill to mean an event that causes, or creates the potential for, levels of disease, injury or death above the levels that would otherwise be expected for the time and place where the event occurs, and in respect of which any of the following applies: the event has or might have a serious impact on public health. Such events will be identified using the decision-making instrument at Annex 2 of the IHR. They 4

might include, for example, the spread of toxic, infectious or otherwise hazardous materials that has the potential to contaminate a population or a large geographic area; in the case of a disease, the event is unusual or unexpected, and has a high potential to spread (whether within Australia or between Australia and another country). Examples of events that are unusual or unexpected are included in Annex 2 of the IHR, such as an emerging or re-emerging communicable disease; otherwise, the event is unusual or unexpected, and the health effects of the event have a high potential to spread (whether within Australia or between Australia and another country). For example, the release of a biological agent causes health effects that are likely to spread. · an overseas mass casualty One of the circumstances in which information may need to be shared between Australian jurisdictions is in the event of an overseas mass casualty such as the Bali bombings in 2002. `Overseas mass casualty' has been defined in the Bill to mean an event occurring overseas, if: more than one person is affected by a disease, or is injured or dies and needs to be repatriated, identified or treated, or needs to be brought to Australia for treatment; and a responsible Commonwealth, State or Territory body is involved in responding to the event, for example, the Department of Foreign Affairs and Trade. · a public health risk `Public health risk' has also been defined in the Bill to mean an event that might adversely affect the health of human populations, and that satisfies any one or more of the following conditions: the health effects of the event might spread within Australia; the health effects of the event might spread between Australia and another country; the health effects of the event might spread between other countries; the event might present a serious and direct danger. The definition is based upon the IHR. A public health risk might include cases of a disease on the national notifiable disease list, an urgent event, or an overseas mass casualty. There may, however, be events that do not come within those other elements of the definition, but are covered by `public health risk'. For example, the occurrence of a disease that is not on the national notifiable disease list, is not occurring at levels higher than usual, but does present a serious and direct danger. National Focal Point The Bill refers to a National Focal Point (NFP), which will liaise with relevant national and international bodies. It also enables the disclosure of certain personal information to, and by, the NFP. The NFP is the Secretary of the Department responsible for the Bill and the persons, offices or positions (if any) nominated in writing by the Secretary. responsible Commonwealth, State or Territory body One of the purposes of Part 2 of the Bill is to describe those organisations with whom the NFP and the Minister can share protected information for the purposes of public health surveillance. These organisations 5

are referred to collectively in the Bill as responsible Commonwealth, State or Territory bodies. They will be determined by the Minister, by legislative instrument. The Minister may determine different bodies for different provisions of Part 2 and may also determine one or more bodies of the Commonwealth and one or more bodies (nominated by a Health Minister) of each State and the Australian Capital Territory, Northern Territory and Norfolk Island. While it is expected that there will generally only be one responsible body for each of those States or Territories, it is possible that more than one body will be determined. Definitions relevant to the regulation of entities handling security-sensitive biological agents (Part 3 of the Bill) biological agents Clause 32 of the Bill requires the Minister to establish a list of SSBA. The list includes those biological agents that the Minister considers to be of security concern to Australia. Clause 3 of the Bill therefore defines `biological agents' for the purposes of the Part. `Biological agents' are defined as including bacteria and viruses that can spread rapidly, as well as toxins derived from biological sources, including animals, plants and microbes. entity This word is used in the Bill to describe those people or bodies likely to handle SSBA. The term has been broadly defined to capture individuals, corporations and government bodies. facility This refers to the range of physical structures where SSBA may be handled and includes buildings, parts of buildings and laboratories, including mobile laboratories. Clause 4 - Binding the Crown The clause provides that the Bill will bind the Crown in each of its capacities and that the Crown may not be prosecuted for a criminal offence against this Bill or regulations. The Bill does provide, at clause 63, for the granting of injunctions. An injunction may be sought in relation to government or other entities. Clause 5 - Application of laws to external Territories This clause provides that the Bill will have application in every external Territory. This means that the legislation will cover, for example, Norfolk Island, the Indian Ocean Territories (Cocos and Christmas Islands), Macquarie and Heard Islands, the Australian Antarctic Territory and the Jervis Bay Territory. Some provisions have particular application to Norfolk Island because it is a self-governing Territory. 6

PART 2--PUBLIC HEALTH SURVEILLANCE DIVISION 1--OBJECTS OF PART Clause 6 - Objects of Part This clause sets out the broad objectives of the Part. These are: · to provide a national system of public health surveillance to enhance the capacity of the Commonwealth, the States and the Territories to identify, and respond to, public health events of national significance which include: the occurrence of certain communicable diseases; or certain releases of chemical, biological or radiological agents; or the occurrence of public health risks; or the occurrence of overseas mass casualties; and · to provide for the sharing of information with the WHO and with countries affected by an event relating to public health or an overseas mass casualty; and · to support the Commonwealth, the States and the Territories in giving effect to the IHR (in any ways other than those mentioned above). DIVISION 2--NATIONAL HEALTH SECURITY AGREEMENT Clause 7 - National Health Security Agreement This clause provides for the making of a National Health Security Agreement, between the Commonwealth, State and the Australian Capital Territory, Northern Territory and Norfolk Island governments to support the operation of the Bill. That agreement may, among other things: · provide for the sharing of information between the Commonwealth, the States and the Territories in relation to communicable diseases; · formalise and enhance consultation between the Commonwealth, the States and the Territories in relation to public health events of national significance; · enhance the ability within Australia to identify and respond quickly to public health events of national significance; and · facilitate the monitoring of public health events of national significance within Australia. It is important to note that this provision in no way limits the power of the Commonwealth to enter into agreements. Nor does it limit the matters that may be covered in the National Health Security Agreement. DIVISION 3--PERMISSIBLE PURPOSES Clause 8 - Permissible purposes One of the purposes of the legislation is to enable the sharing of information between Australian jurisdictions, and also with the WHO and parties to the IHR. Generally, the relevant information provided to responsible bodies (and international bodies) will be de-identified health surveillance data. In limited circumstances, personal 7

information will also need to be shared (for example, details of persons suspected of carrying a pandemic influenza virus travelling across borders, or details of victims of overseas mass casualty events). The legislation therefore enables the sharing of protected information (including personal information) that is obtained under the Bill by relevant government officials for `permissible purposes'. These permissible purposes are described in clause 8 as follows: · preventing, protecting against, controlling or responding to a public health event of national significance (other than an overseas mass casualty); · giving effect to the IHR (other than as mentioned above); · if an Australian suffers from a disease, or is injured or dies, as a result of an overseas mass casualty: facilitating the identification of the Australian (whether in Australia or overseas); the repatriation of the Australian to Australia; and the treatment of the Australian (whether in Australia or overseas); and · if a person who is not an Australian suffers from a disease, or is injured or dies, as a result of an overseas mass casualty: facilitating the identification of the person (whether within Australia or overseas), bringing the person to Australia for treatment and the treatment of the person in Australia. DIVISION 4--NATIONAL FOCAL POINT Clause 9 - Meaning of National Focal Point This clause refers to the National Focal Point (NFP) which will, among other functions, liaise with responsible bodies within Australia in relation to public health events of national significance and liaise with the WHO and other countries in relation to, for example, events that may constitute public health emergencies of international concern. It is proposed that national public health surveillance information be given to the NFP, and then disseminated to affected Commonwealth, State and Territory bodies. The NFP will provide a single contact point for liaison, and for the exchange of information, with the WHO and other countries. The IHR (Article 4) require Australia to designate a NFP as a single contact point for communication with the WHO, to disseminate information from the WHO, and to consolidate public health surveillance information. Clause 9 provides that the NFP means the Secretary and the persons, offices or positions (if any) nominated in writing by the Secretary. It is proposed that the NFP will be the Secretary of the Department of Health and Ageing, and officers within the Department. As the NFP will be required to be accessible at all times to liaise and share information with responsible bodies within Australia, the WHO and other countries, the NFP will operate from the National Incident Room, located in the Office of Health Protection of the Department of Health and Ageing (DoHA). 8

The Minister will determine relevant Commonwealth agencies and bodies nominated by each State, the Australian Capital Territory, the Northern Territory and Norfolk Island with which the NFP will liaise and exchange information (refer to the definition of `responsible bodies' in clause 3). It is proposed that the National Health Security Agreement and administrative protocols with other Commonwealth agencies will set out the operational arrangements between the NFP and responsible bodies for receiving, collecting and sharing health surveillance information and for supporting responses to events where provided by the Bill. Clause 10 - Functions of the National Focal Point This clause provides that the functions of the NFP are: · to liaise with responsible Commonwealth, State or Territory bodies in relation to public health events of national significance; · to liaise with and be accessible to the WHO and State Parties (being countries that are signatories to the IHR) at all times for the purposes of giving effect to the IHR; · to liaise with responsible Commonwealth, State or Territory bodies for the purposes of giving effect to the IHR (for example, dissemination of information from the WHO about events that the Director General of the WHO has determined are public health emergencies of international concern); and · any other functions given to the NFP under the Act or the regulations; or any other Act. DIVISION 5--NATIONAL NOTIFIABLE DISEASE LIST Clause 11 - National Notifiable Disease List This clause provides that the Minister must establish, by legislative instrument, a National Notifiable Disease List (NNDL), after consultation with the Commonwealth Chief Medical Officer and each State and Territory Health Minister. The Minister may include an illness or medical condition in the list if the Minister considers that an outbreak of the illness or condition is a public health risk. A public health risk is an event that might adversely affect the health of human populations, where the health effects might spread within Australia or overseas, or where the event might present a serious and direct danger. The clause also allows the Minister to vary the list (by legislative instrument) either by adding a disease if the Minister considers that an outbreak of the disease would be a public health risk, or removing a disease if the Minister no longer considers that an outbreak of the disease would be a public health risk. When varying the list, the Minister must also consult the Commonwealth Chief Medical Officer and each State or Territory Health Minister. It is proposed that the National Health Security Agreement will set out the operational arrangements for determining or varying the NNDL, including consultation with the States and Territories. It is envisaged that the Australian Health Protection Committee will be the primary vehicle for consultation. 9

Clause 12 - Temporary additions to the National Notifiable Disease List In the case of an emergency, or for an emerging disease, where time does not permit consultation, this clause provides that the Minister or Chief Medical Officer will be able to add a disease, by legislative instrument, to the NNDL on a temporary basis without consultation. Such diseases will remain on the NNDL for a maximum of six months, during which time consultation must occur if the NNDL is to be varied for the longer- term inclusion of the diseases. At the end of the period of six months after the list is varied, the variation ceases to have effect unless the Minister has made a determination that the variation continues to have effect because an outbreak of the disease would be an on-going public health risk. The Minister must not make such a determination unless he/she has first consulted the Commonwealth Chief Medical Officer and each State or Territory Health Minister. Temporary additions to the NNDL are limited to one six month period. DIVISION 6--NOTIFYING, SHARING INFORMATION AND LIAISING WITH RESPONSIBLE COMMONWEALTH, STATE OR TERRITORY BODIES IN RELATION TO PUBLIC HEALTH EVENTS OF NATIONAL SIGNIFICANCE ETC. Clause 13 - Notifying, sharing information and liaising with responsible Commonwealth, State or Territory bodies in relation to public health events of national significance An important objective of the Bill is to provide a legislative basis for existing cooperative arrangements between Australian jurisdictions for the exchange of health information, and to authorise the exchange of certain personal or identified information, for the purposes of national public health surveillance. The Bill aims to authorise, rather than mandate, the exchange of information. In particular, clause 19(1)(b) authorises certain dealings with personal information where those dealings are undertaken in accordance with clause 13 and the other clauses in Divisions 6and 7 of the Bill. To this end, clause 13 enables the Minister to notify any responsible Commonwealth, State or Territory body that is affected, or might be affected, by an event of national significance or an overseas mass casualty. A `public health event of national significance' is defined in clause 3 of the Bill to mean: · one or more cases of a disease listed on the NNDL; or · an urgent event; or · an overseas mass casualty event; or · a public health risk (other than one mentioned above). An `overseas mass casualty' is defined in clause 3 to mean an event occurring overseas if: · more than one person is affected by a disease, or is injured or dies; and needs to be repatriated, identified or treated, or needs to be brought to Australia for treatment; and 10

· a responsible Commonwealth, State or Territory body is involved in responding to the event. The Minister may give a responsible Commonwealth, State or Territory body any relevant information that is available to the Minister in relation to the event, and the Minister may liaise with such bodies in relation to the event. The capacity to notify responsible bodies would be enlivened by a responsible Commonwealth, State or Territory body giving the NFP information relating to a public health event of national significance, or an overseas mass casualty, and the Minister forming the view that it is appropriate to notify other responsible bodies for a permissible purpose. For example, currently Australia's foreign affairs representatives may be contacted about significant overseas events affecting Australians, or where Australia is requested to assist with overseas nationals. It is therefore likely that the Department of Foreign Affairs and Trade will contact the NFP, who will pass on relevant information to other affected responsible bodies to assist in a cohesive effort for the identification, repatriation or treatment of an affected person. Clause 14 - Receipt of information or recommendation from the World Health Organization Where the Director-General of WHO determines that an event is a public health emergency of international concern, and makes recommendations relevant to Australia in relation to a response, this clause enables information to be given by the Minister to relevant responsible bodies within Australia. Specifically, the clause enables the sharing of information with responsible Commonwealth, State or Territory bodies if the Minister has received a recommendation from the WHO (under Part III of the IHR) or any other information provided by the WHO, or any other State Party, under the IHR. A State Party is a country that is a signatory to the IHR. The clause also enables the Minister to give the WHO, or any other State Party, any additional information that is available to the Minister in relation to the recommendation or the information provided by the WHO. If the Minister discloses personal information to a State Party, the Minister must also give a notice specifying the purposes for which the information may be used this is described in clause 27. Clause 15 - Non-personal information This clause provides that the Minister, when dealing with information referred to in this Division that is not personal information, is not prevented from dealing with that information in a manner other than is set out in Part 2 of the Bill. This means that conduct in relation to non-identified information is not restricted by Part 2 of the Bill. 11

DIVISION 7--PUBLIC HEALTH OBSERVATION This Division is intended to give effect to Article 30 of the IHR. It is not intended to provide for general health screening of international travellers arriving in or leaving Australia. It provides for the sharing of certain information about international travellers in-transit whose health requires monitoring, but where their travel does not pose an imminent health threat. Clause 16 - National Focal Point notified of incoming traveller who is under public health observation This clause provides that if the NFP is notified that a traveller who has entered, or will enter, Australia is under public health observation, then the NFP must notify a responsible Commonwealth, State or Territory body. This body must then identify and make contact with the traveller. `Public health observation' is defined in clause 3 of the Bill to mean the monitoring of the health of a person for the purposes of determining the risk of transmission of a disease. The expectation is that contact will normally be made with the traveller, under clause 16(b), by a Commonwealth border agency, following notification by the NFP who have been alerted by the WHO or another country. Alternatively, the agency may be notified directly by the commander of an aircraft or vessel or by the port or airport authority of the overseas country, or an unwell passenger in-transit may self-identify, or otherwise be identified. It is anticipated that a State or Territory agency would become involved in identifying and making contact with a traveller under clause 16(b) if the traveller left the port or airport without contact being made by a Commonwealth agency. The operational arrangements associated with identification and contact with the traveller, including roles and responsibilities, will be set out in the National Health Security Agreement between the Commonwealth and State and relevant Territory governments and in administrative protocols developed by the Department of Health and Ageing and relevant Commonwealth agencies. Clause 17 - Incoming travellers who are placed under public health observation This clause describes the obligations to notify various bodies when an international traveller in-transit is placed under public health observation while they are in an Australia port or airport. The actual placing of a person under public health observation will be done by a responsible body utilizing current processes. For example, the Quarantine Act 1908 provides that people may be placed under quarantine surveillance, and certain conditions may be placed upon their travel or other activities. Clause 17 provides that if a traveller enters Australia and is in transit, and a responsible Commonwealth, State or Territory body places the traveller under public health 12

observation and allows the traveller to continue their journey to a port or airport outside Australia, then: · the responsible Commonwealth, State or Territory body must notify the NFP; and · if the person's first port or airport of arrival outside Australia is in a State Party, the NFP must notify that port or airport, or if that is not reasonably practicable, the State Party's National IHR Focal Point (within the meaning of the IHR); · if the person's first port or airport of arrival outside Australia is not in a State Party, the NFP may notify that port or airport; and · the NFP may notify the last port or airport outside Australia that the person left before arriving in Australia. When providing a notification as described above, the responsible Commonwealth, State or Territory body or NFP must provide the following information: · the name, address and date of birth of the person; · that the person is under public health observation; · the reason for the person being under public health observation; · the name of the ship or flight on which the traveller is travelling after leaving Australia, and the expected time that the ship or flight will arrive at the first port or airport outside Australia; · the name of the ship or flight on which the person left the last port or airport outside Australia, and the time that the ship or flight left; and · any other information set out in regulations. The provision of information about a traveller under public observation to a country that is not a State Party is discretionary. If the NFP is providing information to a State Party (or another country that is not a State Party), the NFP must also give a notice specifying the purposes for which the information may be used (as required by clause 27). DIVISION 8--CONFIDENTIALITY OF INFORMATION Clause 18 - Protected Information `Protected information' is defined, for the purpose of this Part to mean, in summary: · personal information that is obtained under or in accordance with this Part by the Minister or the NFP (or directly from the NFP or the Minister); or · personal information derived from a record, disclosure or other use of the information made under or in accordance with this Part by the NFP or the Minister. The definition of protected information, therefore, captures the ongoing recording, disclosure or use of personal information obtained by the NFP or the Minister and later disclosed by the NFP or the Minister. 13

Clause 19 - Authorisation to use information for permissible purposes Recognising the significance of personal information held by Commonwealth, State and Territory governments, and the importance of maintaining its confidentiality, the Bill provides certain specific authorisations and strong confidentiality protections. Most privacy laws prohibit the disclosure by government officers of personal information except in particular circumstances. One of the circumstances where disclosure of personal information is permitted is when that disclosure is authorised by law. The authorisations referred to in clauses 19 and 20 enable disclosure of personal information under relevant Commonwealth, State and Territory privacy laws. Clause 19 also provides other protections in relation to the authorised recording, disclosure or other use of protected information. Clause 19 sets out three key circumstances in which a person is authorised to make a record of, or disclose, personal or protected information. In summary: · a person may do one or more of the following, in the performance of the person's functions or duties, or the exercise of the person's powers,: on behalf of a responsible Commonwealth, State or Territory body - disclose information (including personal information) to the NFP for a permissible purpose. This authorises the giving of personal information by responsible bodies to the NFP - this personal information is not protected information under the Bill until it is obtained by the NFP or the Minister; make a record of, disclose or otherwise use protected information for a permissible purpose in accordance with Division 6 or 7 of Part 2 of the Act; if the person fits one of the categories of government official described in clause 19(a)(i) to (iv) - make a record of, disclose or otherwise use protected information for a permissible purpose. · the Minister may: disclose protected information to the WHO or a State Party, or make a record of or use protected information for the purpose of giving effect to the IHR. For example, Australia may need to notify the WHO of, and give information about, events which might constitute a public health emergency of international concern (this may be a disclosure for the purposes of Articles 6, 7 and 10 of the IHR). for the purpose of assisting other countries to prevent, protect against, control or respond to an event relating to public health, disclose protected information to a country that is affected or might be affected by the event. The Minister may also make a record of or use protected information for the purpose of determining whether a country is affected by the event. If the Minister discloses personal information to another country (in either this circumstance or the circumstance detailed above), the Minister must also give a notice specifying the purposes for which the information may be used (as required by clause 27). 14

· a person may make a record of, disclose or otherwise use protected information for a specified permissible purpose in accordance with a written authorisation from the Minister. The effect of these provisions is that: · if a person (including the Minister) acts in accordance with the provision then the disclosure of the information (or the recording or other use of the information) will be authorised for the purposes of other laws, such as paragraph (1)(d) of Information Privacy Principle 11 in section 14 of the Privacy Act 1988 or similar laws in the States and Territories; · a person does not commit an offence, and is not liable to any penalty, under the provisions of any other enactment of the Commonwealth, a State or a Territory, as a result of the person making a record, or disclosing or using information, in accordance with the provision; · a person is not liable to civil proceedings for loss, damage or injury of any kind suffered by another person as a result of the person making a record, or disclosing or using information, in accordance with the provision; and · a person does not contravene medical standards, or any other relevant professional standards, as a result of the person making a record, or disclosing or using information, in accordance with the provision. Disclosure of information to WHO in relation to public health emergencies of international concern. Consistent with the IHR, the NFP will assess information received from responsible bodies about public health events of national significance within Australia to determine if the WHO needs to be notified about an event that may constitute a public health emergency of international concern (see Article 6, 13 and Annex 1 of the IHR). The assessment will be informed by the decision instrument at Annex 2 of the IHR. If an event may constitute a public health emergency of international concern, clause 19(4) of the Bill authorises notification to the WHO and the provision of relevant information (see Article 6, 7 and 9 of the IHR). This will enable the Director General of the WHO to determine if a public health emergency of international concern has occurred and commence consultation about an appropriate response (see Article 12 of the IHR). Information may also be provided to the WHO to verify any events alleged to be occurring in Australia that have been reported to the WHO by someone other than the NFP, and to give information to the WHO about public health risks identified outside Australia (see Article 10 of the IHR). 15

Additional information that is, or becomes, available may be provided to the WHO to assist in determining if the event is a public health emergency of international concern, (see Articles 6, 7, 9, 10 and 12 of the IHR). Information relevant to response to certain events may be provided to the WHO (see Articles 8 and 15 to 17 of the IHR). The IHR nominate certain diagnostic and treatment data to be provided to the WHO (see Article 6 of the IHR). The National Health Security Agreement will refer to information that may be shared, such as: the nature of the event; the date, time and nature of any injuries, diseases or deaths and the location of persons affected; timely, accurate and sufficiently detailed public health information; details of any public health measures taken, or that might be taken, in response; and any other information that might assist the WHO to determine whether the event is a public health emergency of international concern. Generally, the information provided to WHO will be de-identified health surveillance data. In limited circumstances, personal information will also need to be provided (for example, details of travellers suspected of carrying a pandemic influenza virus). Clause 20 - Authorisation to use information for purposes of proceedings This clause authorises a person who obtains protected information for a permissible purpose to disclose that information: · to a court or tribunal, or in accordance with an order of a court or a tribunal, for the purposes of proceedings. A note embedded in the clause clarifies that the National Security Information (Criminal and Civil Proceedings) Act 2004 may apply to proceedings under the Part; or · to a coronial inquiry, or in accordance with an order of a coroner, for the purposes of a coronial inquiry. A coronial inquiry is defined in clause 3 to mean a coronial inquiry, coronial investigation or coronial inquest under a law of the Commonwealth, or of a State or Territory. Where information is disclosed to a person for the purpose of proceedings or a coronial inquiry, or disclosed to them in accordance with an order of a court, tribunal or coronial inquiry, that person is authorised to make a record, or discloses or otherwise use the information for the purpose it was disclosed to them. Clause 21 - Offence relating to protected information This clause provides that a person commits an offence if the person obtains protected information and makes a record of, discloses or otherwise uses the information for a purpose that is not authorised by clause 19 or 20. The maximum penalty for such an offence is imprisonment for 2 years. Clauses 22 to 26 describe defences to this offence. These are essentially circumstances in which a person will not be guilty of the offence, however the onus is on the person to prove the defence. 16

It is important to note that protected information under Part 2 of the Bill only includes personal information and that Part 2 of the Bill in no way limits the sharing of other information that is not personal information. Other information, such as de-identified health data, may continue to be shared as it always has been. Clause 22 - Defence of good faith This clause provides that clause 21 does not apply if a person obtains protected information for a permissible purpose and the person discloses the information in good faith in exercising or performing, or purportedly exercising or performing, his or her functions, duties or powers under Part 2 of the Bill on behalf of a responsible Commonwealth, State or Territory body. The note at the end of clause 22 clarifies that a defendant bears an evidential burden in relation to the matter in accordance with subsection 13.3(3) of the Criminal Code. Clause 23 - Defence for use of information also received from another source and use of information by prescribed agencies This clause sets out two circumstances in which clause 21 does not apply. The first relates to information that is also obtained by government officials from another source, and the second relates to information disclosed to and by prescribed intelligence agencies. The offence does not apply to certain government officials (set out at clause 23(1)(b)) who obtain protected information for a permissible purpose and obtain the same, or substantially similar, information from another person and then make a record of (or disclose or otherwise use) the information. However, this only applies where such recording, disclosure or use is authorised under, or not prohibited by, another enactment of the Commonwealth or an enactment of the jurisdiction in which the person is a relevant government official. The effect of this clause is that the operation of the protected information provisions in this Bill does not interfere with the ability of a Commonwealth, State or Territory body to record, disclose and use information in the way that they could if the Bill did not exist that is, if they could obtain, record and disclose or otherwise use that information separately from this Bill. The offence in clause 21 also does not apply to a person who obtains protected information and discloses the information to an officer or employee of a prescribed intelligence agency. It is proposed that Regulations made under the Act will set out the intelligence agencies to which protected information may be disclosed in accordance with this provision. It is envisaged that there will be one or very few prescribed intelligence agencies. This is because certain government officials, including those in intelligence and other agencies, may obtain, record, disclose and otherwise use protected information for permissible purposes under clause 19(2) of the Bill. Clause 23(2) to (4) provides for protected information to be obtained, recorded, disclosed and otherwise used for broader purposes. Those broader purposes are, however, restricted by reference to the 17

performance of the person's functions or duties, or the exercise of the person's powers, as an officer or employee of the prescribed intelligence agency. Clause 23 (3) provides that the clause 21 offence does not apply in circumstances where the officer or employee of the intelligence agency obtains protected information and makes a record of (or discloses or otherwise uses), the information in the performance of their functions or duties, or the exercise of their powers, as an officer or employee of the intelligence agency. The officer or employee of the intelligence agency might, under clause 23(3), disclose protected information in the course of performing their functions and duties or exercising their powers to a person who is not an officer or employee of the intelligence agency. That person may, under clause 23(4), record, disclose or otherwise use the protected information only for the purpose for which it was disclosed to them or for a prescribed purpose. The purpose for which information may be disclosed under clause 23(4)(b)(i) will be a purpose connected with the functions, duties and powers of an intelligence officer. Notes within the clause clarify that in all of the circumstances detailed above, the defendant bears an evidential burden in relation to relevant matters (see subsection 13.3(3) of the Criminal Code). Clause 24 - Defence for disclosure required by another law This clause provides that the offence in clause 21 does not apply if a person obtains protected information for a permissible purpose and: · the person makes a record of, or discloses or otherwise uses, the information; and · the record, disclosure or use is required under another Commonwealth, State or Territory law. This clause only applies where the making of the record, the disclosure or the use of the protected information is required by another enactment. It is intended to ensure that a person does not commit an offence under this Bill if they undertake conduct in relation to protected information that is specifically required under another enactment. Notes within the clause clarify that in these circumstances, the defendant bears an evidential burden in relation to relevant matters (see subsection 13.3(3) of the Criminal Code). Clause 25 - Defence for disclosure to person to whom information relates or if person to whom information relates consents This clause provides that clause 21 does not apply in two situations: · if a person (the first person) obtains protected information for a permissible purpose, the information relates to another person and the first person discloses the information to the other person. If this is the case, clause 21 also does not apply to any of the following: any record of that information that is made by the person to whom the information relates; 18

any disclosure or use of that information by the person to whom the information relates; any record of that information that is made by any other person, or any disclosure or use of that information by any other person, which is derived from a record, disclosure or use referred to above. · if a person (the first person) obtains protected information and: the person to whom the information relates has expressly consented to the first person making a record of, or disclosing or using, the information for a certain purpose; and the first person makes the record, or discloses or uses the information, for that purpose. Notes within the clause clarify that in all of the circumstances detailed above, the defendant bears an evidential burden in relation to relevant matters (see subsection 13.3(3) of the Criminal Code). Clause 26 - Defence for disclosure to person who provided the information This clause provides that clause 21 does not apply if a person obtains protected information from another person and then discloses that information back to the other person. For example, a person may lose a document that they give to another person, but a copy of that document may be given back to them. The defendant bears an evidential burden in relation to this matter. DIVISION 9--MISCELLANEOUS Clause 27 - Notice to other countries about further use of information This clause provides that where personal information is provided to an IHR signatory country for IHR purposes, the country must be given a notice referring to the confidentiality provisions of Article 45 of the IHR. If the personal information is given to an IHR signatory country for a purpose other than giving effect to the IHR, the Minister must give the State Party a written notice specifying the purposes for which a record may be made of the information, or how the information may be used or disclosed. Where personal information is provided by the Minister or the NFP to another country that is not a signatory to the IHR, the country must be given a notice stating the purpose for which the information may be recorded, used or disclosed. Sub-clause 27(4) clarifies that personal information is considered to have been given to another country if the information is given to a body at, or a body with responsibilities for, a port or airport in the other country, or to the other country's National IHR Focal Point (within the meaning of the IHR). Clause 28 - Delegation This clause provides that the Minister may delegate any of his or her functions or powers under this Part to a Senior Executive Service (SES) employee, or an acting SES 19

employee, of the Department. In performing a delegated function or exercising a delegated power, a delegate must comply with any written directions of the Minister. Clause 29 - Annual report The Secretary must, as soon as practicable after 30 June in each year, prepare a report on the use, by the Commonwealth, of protected information (within the meaning of the definition of protected information as it relates to Part 2 of the Act), during the previous 12 months. The report must be included in the annual report of the Department. 20

PART 3--REGULATION OF SECURITY-SENSITIVE BIOLOGICAL AGENTS Biological agents with the potential to cause harm to human health consist of infectious agents, such as bacteria and viruses that can spread rapidly within a population, and toxins derived from animals, plants or microbial material. There is a potential for either the deliberate or unintentional use or release of a SSBA to cause serious harm to human health, the environment and the Australian economy. Currently there is no nationally consistent legislation that covers security risks for all facilities and entities that handle SSBA. Indeed, it is not possible to accurately identify those facilities and entities that handle SSBA, or their location. This presents risks because: · there are limited physical security requirements for facilities and entities holding or using SSBA; · there is no means of monitoring the location, nature or destruction of SSBA; · there is no requirement for checking of facility and entity employees with access to SSBA to ensure that they do not have criminal or terrorist links; and · facilities and entities generally do not record individual access to SSBA. The COAG Hazardous Biological Materials Review Working Group recommended that the most effective and efficient means of minimising security risks posed by SSBA would be to establish a national regulatory scheme. The recommendations of the COAG Working Group as well as contact details for obtaining a copy of the COAG Report, Report on the Regulation and Control of Biological Agents, is available at the COAG website: http://www.coag.gov.au/meetings/130407/index.htm Further information is available from the Department of Health and Ageing at: COAG.Review.Biological.Agents@health.gov.au. Consistent with the recommendations of the COAG Hazardous Materials Review, this Part of the Bill implements a regulatory scheme for entities that handle SSBA. DIVISION 1--PRELIMINARY Clause 30 - Object of Part The object of Part 3 of the Bill is to give effect to Australia's obligations to establish controls for the security of certain biological agents that could be used as weapons. To achieve this object, Part 3 provides for: · the collection, and recording on a National Register, of information about the nature and location of SSBA legitimately handled by entities in Australia; · requirements to be complied with for the secure handling of SSBA; · monitoring of compliance with reporting and handling requirements through an inspection program; and · restrictions in relation to the handling of SSBA. 21

DIVISION 2--THE LIST OF SECURITY-SENSITIVE BIOLOGICAL AGENTS Clause 31 - Establishment of the List of Security-sensitive Biological Agents This clause provides that the Minister must establish a list of biological agents (to be known as the List of Security-sensitive Biological Agents) that the Minister considers to be of security concern to Australia. While the legislation does not limit the agents that can be included on the list, this clause provides that: · the Minister may consider a biological agent to be of security concern to Australia if the biological agent could be developed, produced, stockpiled, acquired or retained in types and quantities that could allow the biological agent to be used as a weapon; and · if the Minister includes a toxin in the list, the Minister may also specify in the list a quantity (the reportable quantity) of that toxin. It is intended that the List of SSBA will include dangerous live, viable and pathogenic agents that can spread rapidly and toxins derived from animals, plants or microbial material. As noted above, where toxins are included, a reportable quantity may be specified as only certain quantities of particular toxins will be security-sensitive. Clause 34 provides that the Secretary must keep an up-to-date copy of the List of SSBA on the Department of Health and Ageing's website. To assist readers, the clause clarifies that the List of SSBA is not a legislative instrument for the purposes of the Legislative Instruments Act 2003. Clause 32 - Variation of the List of Security-sensitive Biological Agents This clause provides that the Minister may, in writing, vary the List of SSBA by: · including a biological agent and, if applicable, a reportable quantity of that agent in the list if the Minister considers the biological agent to be of security concern to Australia; · removing a biological agent and, if applicable, a reportable quantity of that agent from the list if the Minister no longer considers the biological agent to be of security concern to Australia; · changing the reportable quantity of a biological agent in the list; or · correcting an inaccuracy. To assist readers, the clause notes that an instrument varying the List of SSBA is not a legislative instrument for the purposes of the Legislative Instruments Act 2003. Following a variation to the list, the copy of the list kept on the Department of Health and Ageing's website (in accordance with clause 34) will be updated. Clause 33 - Minister must obtain and have regard to expert advice This clause provides that the Minister must not include a biological agent, or a reportable quantity of a biological agent, in the List of SSBA (or otherwise vary the list) unless the Minister has first received necessary advice. 22

The Minister must seek (and have regard to) advice from: · any agency or instrumentality of the Commonwealth that has responsibility for obtaining and assessing information about the risks and threats posed by biological agents that may be of security concern to Australia; · people with scientific or technical knowledge of biological agents that may be of security concern to Australia. These persons may also be officers or employees of an agency or instrumentality of the Commonwealth referred to above; and · the States and the Australian Capital Territory and the Northern Territory. It is expected that the Australian Chemical, Biological, Radiological, Nuclear (CBRN) Data Centre within the Australian Federal Police will be the principal source of technical advice and security intelligence for the establishment and variation of the List of SSBA. The CBRN Data Centre presently has responsibility for updating the COAG Biological Agents List, based on intelligence and technical inputs. It is expected that in practice the List of SSBA will reflect any changes to the COAG List. Clause 34 - List to be available on the Department's website The Secretary is to ensure that an up-to-date copy of the List of SSBA is available on the Department's website. DIVISION 3--STANDARDS RELATING TO SECURITY-SENSITIVE BIOLOGICAL AGENTS Clause 35 - Minister may determine standards relating to security-sensitive biological agents This clause provides that the Minister may, by legislative instrument, determine standards relating to SSBA (SSBA Standards) following consultation with: · persons with scientific or technical knowledge in relation to the security of biological agents; · the States and the Australian Capital Territory and the Northern Territory; and · any other person who the Minister considers may assist the Minister in developing a standard. Without limiting the matters to which an SSBA Standard can relate, a standard may set out requirements relating to, for example: · the storage of SSBA; · the security status of individuals who are entitled to handle or dispose of SSBA; and · the transport of SSBA. An SSBA Standard may also set out different requirements to be complied with in respect of different SSBA. The relevance of the SSBA Standards in the overall regulatory regime is that the SSBA Standards must be complied with by entities that handle SSBA. Standards will be developed in consultation with scientific and technical experts, along with other important stakeholders such as State and Australian Capital Territory and Northern 23

Territory agencies, industry representatives and intelligence agencies. This is intended to ensure that they are effective, and respond to industry requirements. Entities handling SSBA will be required to comply with the SSBA Standards, irrespective of whether they are registered entities. DIVISION 4--THE NATIONAL REGISTER Clause 36 - National Register of Security-sensitive Biological Agents This clause provides that there is to be a National Register of Security-sensitive Biological Agents. The National Register is to be maintained in an up-to-date form by the Secretary, and may be kept in a computerised form. Information included on the National Register must not be disclosed except in accordance with Division 9. Clause 37 - Content of National Register If the Secretary decides, under clauses 44 or 47, to register an entity in relation to one or more SSBA handled by the entity at one or more facilities, this clause provides that the Secretary must include the following particulars in the National Register: · the name of the entity; · the name and address of each facility where the entity handles SSBA; · the name of each SSBA handled by the entity at each facility; · the purpose for which each such SSBA is handled by the entity; · if the decision to register is made under clause 47(2) (which provides for registration on a temporary basis) - a statement to this effect; · such other particulars as are prescribed by the regulations. Clause 38 - Variation of the National Register This clause provides that the Secretary may vary the particulars included in the National Register to correct an inaccuracy. The Secretary must also vary the National Register to take account of: · decisions made by the Secretary under clause 47, 49 or 52 in relation to a registered entity; and · any disposals of an entire holding of SSBA, losses or thefts of SSBA that were included on the National Register in relation to a registered entity at a facility; and DIVISION 5--REQUIREMENTS FOR ENTITIES THAT HANDLE SECURITY SENSITIVE BIOLOGICAL AGENTS Subdivision A--Application and definitions Clause 39 - Application of Division This Division applies to an entity that handles one or more SSBA at one or more facilities, and is not an exempt entity. An exempt entity is defined in clause 40 to mean, in summary, an entity that handles SSBA only for the purpose of transporting them, or an entity prescribed by the regulations to be an exempt entity. 24

If a SSBA is a toxin in relation to which a reportable quantity is specified in the List of SSBA, then the entity is not considered to handle that toxin at a facility unless the entity handles, at that facility, at least the reportable quantity of that toxin. The effect of this provision is that if an entity handles a very small amount of toxin at a particular facility, then it does not need to comply with the requirements of this Division. Clause 40 - Meaning of exempt entity This clause defines an exempt entity to be one that: · handles the SSBA only for the purpose of transporting them from one place to another place. While such entities are not required to comply with this legislation, they must comply with Commonwealth, State and Territory laws relating to the transport of dangerous goods; or · is an entity, or a kind of entity, prescribed by the regulations to be an exempt entity. Regulations may exempt an entity, or a kind of entity, in relation to: all SSBA handled by the entity or kind of entity; or a specified SSBA, or class of SSBA. The class may also be described by reference to a particular facility. Clause 41 - Meaning of legitimate purpose This clause provides that, for the purposes of Part 3 of the Bill, each of the following is a legitimate purpose for an entity to handle a SSBA: · to carry out scientific or medical work with the SSBA to develop or produce a vaccine or treatment for it, or to better understand a disease it causes; · in relation to a SSBA that is a toxin--to carry out scientific or medical work in relation to the applications of the toxin. For example, in treating cancer or, in the case of Botox (botulinum toxin), for medical or cosmetic use; · to carry out diagnostic analysis of samples infected with a SSBA, or samples contaminated with a toxin, provided that the analysis is carried out at a veterinary, diagnostic or pathology laboratory; · to carry out research that the Secretary considers is responsible and legitimate. The Secretary must consult with persons with scientific or technical knowledge in relation to SSBA before making such a decision, and must also have regard to any advice given by the persons consulted. The Secretary may also consult any other person who the Secretary considers may assist the Secretary in making a decision; · to carry out forensic procedures in relation to the SSBA for law enforcement purposes; · if the entity is an agency or instrumentality of the Commonwealth, a State or a Territory that is responsible for testing or carrying out other activities in relation to the SSBA - to carry out that testing or those other activities in relation to the SSBA. This provision would include regulatory activities of government agencies, for example, any work involving biological agents that the Therapeutic Goods Administration undertakes in the course of evaluating and testing therapeutic goods; and · any other purpose determined by the Minister, by legislative instrument, to be a legitimate purpose. The Minister must not make such a determination unless the Minister has consulted with, and had regard to any advice provided by, persons with scientific or technical knowledge in relation to SSBA, and the States and the 25

Australian Capital Territory and the Northern Territory. The Minister may also consult any other person who the Minister considers may assist the Minister in relation to a determination. Subdivision B--Reporting requirements Clause 42 - Entity that handles security sensitive biological agents must give a report to the Secretary This clause requires that any entity to which this Division applies (other than a registered entity) must give a report to the Secretary within two business days after the entity starts to handle a SSBA (or within such longer time as specified in a written notice given to the entity by the Secretary). The Regulations may, however, set out circumstances in which such a report is not required. The report that the entity gives to the Secretary must be in a form approved by the Secretary, must state that the entity is complying with the SSBA Standards, and must contain the following information: · the name of the entity; · the name and address of each facility where the entity handles a SSBA; · the name of each SSBA handled at each facility; · the purpose for which each SSBA is handled. Clause 41 sets out the purposes that are legitimate purposes for an entity to handle a SSBA; and · any other information required by the approved form. Failure to give such a report to the Secretary is an offence under clause 43. It should be noted that it is the responsibility of the entity (where the entity is a body corporate or an agency or instrumentality of the Commonwealth, or of a State or a Territory) to submit the report. If an individual works for such an entity and their duties include handling a SSBA, the individual is not required to give a report to the Secretary. This is described in clause 55. In order to ensure a smooth transition to the new regulatory requirements, this clause provides that if an entity is handling one or more SSBA at the commencement of this provision, then the entity is taken to start to handle those SSBA one month after the commencement of this clause. Clause 43 - Offence--failure to give a report to the Secretary This clause creates an offence for an entity that is required to give a report to the Secretary under clause 42 and does not give the report to the Secretary as required. The maximum penalty is 500 penalty units for an individual and 2,500 for a body corporate (as per subsection 4B(3) of the Crimes Act 1914). A penalty unit is equivalent to $110 (as per subsection 4AA(1) of the Crimes Act 1914). 26

Clause 44 - Secretary must consider report and decide whether or not to include entity on the National Register If the Secretary receives a report from an entity (under clause 42), the Secretary must decide whether or not to register the entity in relation to any or all of the SSBA and facilities specified in the report. For the purpose of making such a decision, the Secretary may, by written notice to the entity: · request the entity to provide such further information as the Secretary requires within the period specified in the notice, or within such longer period as the Secretary allows. Such a notice must state that, if the entity does not provide the information within the period allowed, the Secretary may require the entity to dispose of its entire holdings of any or all of the SSBA specified in the report; and/or · request the entity to allow an inspector to inspect a specified facility of the entity at a reasonable time. The Secretary must decide to register the entity in relation to a SSBA and a facility specified in the entity's report if: · the entity provided all the information required (as well as any further information requested by the Secretary); · the entity stated in the report that it is complying with the SSBA Standards; and · the Secretary is satisfied that the purpose stated in the entity's report for which the entity is handling that SSBA at that facility is a legitimate purpose. The Secretary is not required to determine that the entity is actually handling the agent for a legitimate purpose. The Secretary must notify the entity in writing of the Secretary's decision, and the notice must include the information (if any) prescribed by the regulations. If the entity has not provided the required information or does not state that it is complying with the SSBA Standards, then clause 45 applies. This clause enables the Secretary to direct that an entity dispose of its SSBA. If the entity does provide the required information and states it is complying with the SSBA Standards, but the stated purpose for handling the SSBA is not a legitimate one, then clause 47 applies. This clause enables the Secretary to register the entity on a temporary basis. If the Secretary registers an entity on a temporary basis the Secretary must notify the entity of the temporary nature of the registration, the reason for temporary registration and that handling an agent for a purpose that is not legitimate may be an offence under the Crimes (Biological Weapons) Act 1976. Clause 45 - Secretary may direct entity to dispose of security-sensitive biological agents This clause enables the Secretary to give a written direction to an entity, requiring the entity (within a required period), to dispose of any or all of the SSBA specified in the report. 27

The Secretary is empowered to take such action if the entity has given the Secretary a report under clause 42 and the Secretary requested additional information from the entity and the entity did not comply with the request within the period allowed. The Secretary may also require the disposal of SSBA if the entity did not state in the report that the entity is complying with the SSBA Standards. If the Secretary requires disposal, then the Secretary must allow the entity a reasonable time to comply with this requirement having regard to the circumstances. Failure to comply with a direction to dispose of a SSBA is an offence under clause 46. If the Secretary does not consider that disposal is the most appropriate approach, the Secretary may, as an alternative, direct a particular individual not to handle SSBA (in accordance with clause 59). For example, this approach may be taken by the Secretary where a number of individual entities handle the same SSBA, and only one of those individuals has failed to comply in the manner described in clause 45(1). If the Secretary gives a notice to an entity under this clause, the Secretary must not include the entity on the National Register in relation to the SSBA and the facility to which the notice relates. Clause 46 - Offence--failure to comply with direction to dispose of security-sensitive biological agent This clause provides that an entity commits an offence if the entity does not comply (within the period allowed) with a direction given under sub-clause 45(2). The maximum penalty is 500 penalty units for an individual and 2,500 for a body corporate (as per subsection 4B(3) of the Crimes Act 1914). A penalty unit is equivalent to $110 (as per subsection 4AA(1) of the Crimes Act 1914). The clause also ensures that subsection 4K(2) of the Crimes Act 1914, which creates daily or continuing offences, does not apply to the offence. Clause 47 - Secretary not satisfied entity handling security-sensitive biological agent for a legitimate purpose This clause applies if an entity gives the Secretary a report in relation to the handling of SSBA (under clause 42) and the entity provided all of the required information and states that it was compliant with the SSBA Standards, but the Secretary is not satisfied that the purpose stated in the report for which the entity is handling that SSBA at that facility is a legitimate purpose. In this case, the Secretary must register the entity, on a temporary basis and notify the entity in writing. The Secretary must detail the reason that the entity has been registered on a temporary basis and note that handling a SSBA for a purpose other than a legitimate purpose may be an offence against the Crimes (Biological Weapons) Act 1976. The Secretary may also refer the matter to the relevant authorities for investigation. 28

This Bill does not describe offences for handling a SSBA without a legitimate purpose. The Crimes (Biological Weapons) Act 1976 includes offences of that nature, and provides for forfeiture and seizure of substances related to such offences. If the entity is convicted of an offence against the Crimes (Biological Weapons) Act 1976 (in relation to its handling of the SSBA at the facility) or is found to have committed such an offence but no conviction is recorded, the Secretary must cancel the temporary registration of the entity in relation to the SSBA and the facility. If, within 12 months, no prosecution is instituted against the entity for an offence against the Crimes (Biological Weapons) Act 1976, or a prosecution is instituted within 12 months but the entity is found not to have committed the offence, the Secretary must vary the National Register to indicate that the registration is no longer on a temporary basis. This variation must occur as soon as practicable after: · the Secretary becomes aware of a decision not to prosecute; or · the expiry of 12 months since temporary registration; or · the end of proceedings where an entity was found not to have committed an offence. Clause 47(9) authorises a person or authority that conducts investigations or institutes or carries on prosecutions for offences against the Crimes (Biological Weapons) Act 1976 to disclose personal information to the Secretary for the purpose of assisting the Secretary to keep the National Register in an up-to-date form. This provision constitutes an authorisation for the purposes of other laws, such as privacy laws. Clause 48 - Registered entity must report any changes to the Secretary This clause requires that registered entities must give a report to the Secretary about any `reportable events' in relation to the handling of SSBA. Each of the following is a reportable event in relation to a registered entity: · the entity starts to handle at a facility a SSBA that is not included on the National Register in relation to the entity and that facility; · the entity disposes of its entire holdings of a SSBA that is included on the National Register in relation to the entity and a facility (including a disposal required by a direction given by the Secretary under this Part); · if the entity is included on the National Register in relation to a facility and a SSBA that is a toxin, the entity disposes of a quantity of the toxin and after the disposal, the quantity of the toxin handled by the entity at that facility is less than the reportable quantity of that toxin; · the entity starts to handle, a SSBA that is included on the National Register in relation to the entity and a facility for a purpose other than the purpose specified in the National Register, or stops handling a SSBA that is included on the National Register in relation to the entity and a facility for a purpose specified in the National Register; · the entity transfers a SSBA that is included on the National Register in relation to the entity and a facility to another entity, or to another facility of the entity; · a SSBA that is included on the National Register in relation to the entity and a facility is lost or stolen. As well as reporting this to the Secretary under this legislation, it 29

may also be necessary to report this under State or Territory legislation (for example, if there is an accidental or deliberate releases of SSBA that could cause harm to human health or the environment); · a person accesses a SSBA that is included on the National Register in relation to the entity and a facility, and the access is unauthorised under the regulations. The regulations may prescribe the circumstances in which access to a SSBA, or a specified class of SSBA, is unauthorised; and · any other event prescribed by the regulations. If a reportable event occurs, then the entity must give a report to the Secretary. The report must: · be given within the period set out in regulations. It is anticipated that the regulations could prescribe different periods in relation to different reportable events. It is also possible that the regulations will prescribe a period in relation to a reportable event that could end before or after the event occurs. For example, transfer of a SSBA may be required to be reported before it occurs; and · be in a form approved by the Secretary and include the information required by the approved form. The regulations may provide that reportable events do not need to be reported to the Secretary in certain circumstances. Clause 49 - Secretary must consider report of changes and decide whether or not to vary the National Register If the Secretary receives a report about a reportable event, the Secretary must decide whether or not to vary the National Register to take account of the event. In deciding whether or not to do this, the Secretary may: · request the entity to provide further information (within a certain time). Such a notice must state that, if the entity does not comply with the request for information, the Secretary may require the entity to dispose of its entire holdings of any or all of the SSBA to which the report relates; and/or · request the entity to allow an inspector to inspect a specified facility at a reasonable time. Clause 49 sets out the circumstances in which the Secretary must decide to vary the register to take account of the reportable event. These are: · if the entity provided all the information required by the form approved for reporting `reportable events', and any further information requested under clause 49(2)(a); and · in the case of two reportable events detailed below, in addition to receiving all the required information, the Secretary is satisfied that the purpose stated in the report for handling the SSBA is legitimate. The two relevant reportable events are: the entity starts to handle at a facility a SSBA that is not included on the National Register; or the entity starts to handle a SSBA included on the National Register (in relation to that entity and a facility) for a purpose other than the purpose specified in the National Register. 30

Once the Secretary has made a decision about whether to vary the Register, the Secretary must notify the entity in writing of the decision and include any information in the notice that is detailed in the regulations. Clause 50 - Secretary may direct entity to dispose of security-sensitive biological agents If a registered entity has given the Secretary a report under clause 48, and the Secretary has requested further information, yet the registered entity has not complied with this request within the period allowed, the Secretary may require the entity to dispose of its entire holdings of a SSBA. This must be done within the period specified in a written direction, or such longer period as the Secretary allows (noting that the period specified in a direction must be reasonable having regard to the circumstances). Before giving such a written direction, the Secretary will consider whether this is an appropriate action given the specific circumstances. In some cases, the Secretary may not consider disposal to be appropriate if, for example, the entire holdings have already been disposed of, or were lost or stolen. In other cases, the Secretary may consider that it is more appropriate to direct a particular individual not to handle SSBA (refer clause 59). This approach may be taken by the Secretary where a number of individual entities handle the same SSBA, and only one of those individuals has failed to comply. Failure to comply with a direction to dispose of a SSBA is an offence under clause 51. Clause 51 - Offence--failure to comply with direction to dispose of security-sensitive biological agent This clause provides that an entity commits an offence if it does not comply with a direction (given under clause 50) to dispose of a SSBA within the period allowed. The maximum penalty for non-compliance is 500 penalty units for an individual and 2,500 penalty units for a body corporate. A penalty unit is currently equivalent to $110 (as set out in subsection 4AA(1) of the Crimes Act 1914). The clause also provides that section 4K of the Crimes Act 1914 does not apply to such an offence. This means that the offence is not a daily or continuing one. Clause 52 - Secretary not satisfied entity handling security-sensitive biological agent for a legitimate purpose Under clause 48, registered entities must report any changes in relation to the handling of the SSBA (these are referred to as `reportable events'). Particular arrangements are relevant to the following two reportable events: · if the entity starts to handle at a facility a SSBA that is not included on the National Register in relation to the entity and that facility; and · if the entity starts to handle a SSBA that is included on the National Register in relation to the entity and a facility for a purpose other than the purpose specified in the National Register. 31

If one of these two reportable events has occurred, the entity may have reported these changes (and provided any additional information requested by the Secretary) but the Secretary still may not be satisfied that the purpose for which the entity states it is handling the SSBA is a legitimate purpose. In these circumstances, the Secretary must decide to vary the National Register, on a temporary basis, to take account of the reportable event and notify the entity in writing of that fact. The notice given to the entity must also state the reason for the temporary variation, and that handling a SSBA for a purpose other than a legitimate purpose may be an offence against the Crimes (Biological Weapons) Act 1976. The Secretary may also refer the matter to the relevant authorities for investigation. This Bill does not describe offences for handling a SSBA without a legitimate purpose. The Crimes (Biological Weapons) Act 1976 includes offences of that nature, and provides for forfeiture and seizure of substances related to such offences. The Secretary must cancel the temporary variation if the entity is convicted of an offence against the Crimes (Biological Weapons) Act 1976 in relation to its handling of the SSBA, or the entity is found to have committed such an offence but no conviction is recorded. The Secretary must vary the National Register to indicate that the variation is no longer on a temporary basis if: · no prosecution is instituted within 12 months against the entity for an offence against the Crimes (Biological Weapons) Act 1976 in relation to the entity's handling of the SSBA to which the reportable event relates; or · such a prosecution is instituted within 12 months but the entity is found not to have committed the offence. This variation to the National Register must occur as soon as practicable after: · the Secretary becomes aware of a decision not to prosecute; or · the expiry of 12 months since temporary registration; or · the end of proceedings where an entity was found not to have committed an offence. Clause 52(9) authorises a person or authority that conducts investigations or institutes or carries on prosecutions for offences against the Crimes (Biological Weapons) Act 1976 to disclose personal information to the Secretary for the purpose of assisting the Secretary to keep the National Register in an up-to-date form. This provision constitutes an authorisation for the purposes of other laws, such as privacy laws. Clause 53 - Failure to report changes to the Secretary This clause enables the Secretary to give a registered entity a written notice stating that, if the entity does not comply with the requirement to report certain `reportable events' in relation to SSBA, the Secretary may require the entity to dispose of its entire holdings of the SSBA to which the reportable event relates. 32

The Secretary may only take such action if the Secretary believes, on reasonable grounds, that: · a reportable event has occurred in relation to a registered entity (reportable events are described in clause 48); and · the entity did not give a report to the Secretary about the reportable event as required. If the Secretary gives an entity a written notice (as described above) and the entity still does not report the reportable events as required, the Secretary may, if considered by the Secretary to be appropriate, give a further direction to the entity, requiring the entity to dispose of its entire holdings of the SSBA to which the reportable event relates. The period specified for disposal must be reasonable having regard to the circumstances. Failure to comply with such a direction is an offence under clause 54. Clause 54 - Offence--failure to comply with direction to dispose of security sensitive biological agent This clause provides that an entity commits an offence if they do not comply with a direction given to the entity under sub-clause 53(3) (within the period allowed under that sub-clause). The maximum penalty is 500 penalty units for an individual and 2,500 for a body corporate (as per subsection 4B(3) of the Crimes Act 1914). A penalty unit is equivalent to $110 (as per subsection 4AA(1) of the Crimes Act 1914). Subsection 4K(2) of the Crimes Act 1914, which creates daily or continuing offences, does not apply to this offence. Clause 55 - Application of reporting requirements in relation to individuals This clause clarifies the responsibilities of individuals who work within companies or government agencies, in relation to reporting SSBA to the Secretary. The clause provides that an individual is not required to give a report to the Secretary under clauses 42 or 48 (in relation to a SSBA at a facility) if: · the individual is an officer or an employee of an entity (that is, a body corporate or an agency or instrumentality of the Commonwealth, a State or a Territory) or is engaged as a consultant or a contractor by such an entity; and · the individual's duties include handling a SSBA at a facility of the entity; In these cases, it is the entity (that is, the body corporate, agency or instrumentality) that is required to give the report to the Secretary. If two or more individuals handle one or more SSBA at the same facility and each individual is required to give the Secretary a report (under clauses 42 or 48) then each individual may give the Secretary a report, or all of the individuals, acting jointly may give the Secretary a joint report. Either way, the individuals will be compliant with the legislation. 33

Subdivision C--Compliance with SSBA Standards Clause 56 - Entity must comply with SSBA Standards An entity that handles one or more SSBA at one or more facilities must comply with the SSBA Standards in relation to each SSBA it handles at each facility. This provision applies to an entity that handles SSBA even if the entity is not a registered entity. Clause 57 - Failure to comply with SSBA Standards This clause provides that the Secretary may give an entity a written notice stating that, unless the entity satisfies the Secretary (within the period specified in the notice or such longer period as the Secretary allows) that the entity is complying with the SSBA Standards, the Secretary may require the entity to dispose of its entire holdings of the SSBA at that facility. The Secretary may take this action if the Secretary believes, on reasonable grounds, that an entity is not complying with the SSBA Standards in relation to a SSBA that the entity handles at a facility. Such a notice may relate to any or all of the SSBA handled by the entity or any or all of the facilities at which the entity handles those SSBA. If the Secretary gives an entity such a notice (requiring them to comply with the SSBA Standards) and the entity does not satisfy the Secretary that it is complying (within the period allowed), the Secretary may give a written direction to the entity, requiring the entity (within a certain reasonable period) to dispose of its entire holdings of that SSBA at that facility. Failure to comply with such a direction is an offence under clause 58. The Secretary may, as an alternative to requiring disposal, direct a particular individual not to handle SSBA (refer clause 59). This approach may be taken by the Secretary where a number of individual entities handle the same SSBA, and only one of those individuals has failed to comply in the manner described in clauses 56 and 57. Clause 58 - Offence--failure to comply with direction to dispose of security sensitive biological agent This clause provides that an entity commits an offence if the entity does not comply with a direction (given under clause 57) to dispose of SSBA within the period allowed. The maximum penalty that may be imposed for such an offence is 500 penalty units for an individual and 2,500 for a body corporate. The value of a penalty unit is described in subsection 4AA(1) of the Crimes Act 1914 and is currently $110. Subsection 4K(2) of the Crimes Act 1914, which creates daily or continuing offences, does not apply to this offence. 34

Subdivision D--Directions not to handle security-sensitive biological substances Clause 59 - Secretary may direct individual not to handle SSBA This clause enables the Secretary to issue a written notice to an individual directing the individual not to handle one or more specified SSBA if the Secretary considers, on reasonable grounds, that: · an individual who is handling a SSBA at a facility has not complied with Part 3 of the Bill, any relevant regulations or the SSBA Standards, and it would not be appropriate to require the individual or another entity to dispose of the SSBA; or · the handling of a SSBA at a facility by a particular individual poses a security risk. The written notice may direct the individual not to handle one or more specified SSBA at any time in the future, or until the individual satisfies the Secretary that the individual has: · satisfactorily completed specified training; or · obtained a specified qualification or certification; or complied with any requirements specified in the regulations. The Secretary may give a notice to an individual under this clause instead of, or in addition to, giving a direction to the individual or another entity requiring the individual or other entity to dispose of particular SSBA. Failure to comply with a direction under this clause is an offence under clause 60. Clause 60 - Offence--failure to comply with direction not to handle security- sensitive biological agents This clause establishes an offence where an individual fails to comply with a direction, given under clause 59, not to handle a SSBA. The maximum penalty for such an offence is 500 penalty units (the value of a penalty unit is set out in subsection 4AA(1) of the Crimes Act 1914 and is currently $110). Subsection 4K(2) of the Crimes Act 1914, which creates daily or continuing offences, does not apply to this offence. DIVISION 6--ENFORCEMENT Clause 61 - Secretary may arrange for disposal of security-sensitive biological agents This clause enables the Secretary to arrange for the disposal of SSBA if the entity is: · given a direction (under clauses 45, 50, 53 or 57) and the entity does not comply with the direction within the period allowed; or · convicted of an offence against clause 43 (that is, the entity has been convicted of the offence of failing to give a report to the Secretary that the entity is handling SSBA (as required by clause 42)). If the Secretary incurs costs as a result of making such arrangements, the entity is liable to pay to the Commonwealth an amount equal to the cost, and the amount may be recovered by the Commonwealth as a debt due to the Commonwealth. 35

Clause 62 - Injunctions If a person has engaged, is engaging, or is about to engage in any conduct that is or would be an offence against Part 3 of the Bill or regulations, this clause provides that the Federal Court or the Federal Magistrates Court may grant an injunction, on application by the Secretary, to restrain that person from engaging in that conduct. Likewise, if a person has refused or failed, is refusing or failing, or is about to refuse or fail, to do any thing, and such a refusal or failure is or would be an offence against this Part of the Bill, then the Court may, on application by the Secretary, grant an injunction requiring the person to do the thing. The Court's powers to grant injunctions under this clause may be exercised whether or not it appears to the Court that the person intends to engage, or to continue to engage, in conduct of that kind, and whether or not the person has previously engaged in conduct of that kind. The Court is empowered to discharge or vary any injunction granted under the clause, and the Court may also grant an interim injunction pending the determination of an application for an injunction. The clause makes it clear that the powers of the Court set out under this clause are in addition to, and not in derogation of, any of the other powers of the Court. DIVISION 7--POWERS OF INSPECTION Subdivision A--Appointment of inspectors and identity cards Clause 63 - Appointment of inspectors This clause provides that the Secretary may, by instrument in writing, appoint a person who is appointed or employed by the Commonwealth, as an inspector. Before making such an appointment, the Secretary must be satisfied that the person has appropriate skills and experience. In exercising powers or performing functions as an inspector, an inspector must comply with any directions of the Secretary. For example, the Secretary may direct an inspector to provide a report in relation to their exercise of any power or performance of any function. Clause 64 - Identity card This clause provides that the Secretary must issue the inspector with an identity card that is in the form prescribed by the regulations and includes a recent photograph of the inspector. An inspector must carry his or her identity card at all times when exercising powers or performing functions as an inspector. 36

If a person to whom an identity card has been issued ceases to be an inspector, the person must return the identity card to the Secretary as soon as practicable. Failure to comply with this requirement may give rise to a maximum penalty of 1 penalty unit. Subdivision B--Monitoring compliance Clause 65 - Powers available to inspectors for monitoring compliance This clause provides that an inspector may enter any premises and exercise the monitoring powers (as set out in clause 66) in order to: · find out whether this Part, or regulations made for the purposes of this Part, or the SSBA Standards, have been complied with; · verify that the information given to the Secretary by an entity under clause 42, 44, 48 or 49 is accurate and up-to-date. An inspector is not authorised to enter premises unless the occupier of the premises has consented to the entry, or the entry is made under a monitoring warrant. Clause 66 - Monitoring powers This clause sets out the monitoring powers that an inspector may exercise under paragraph 65(1)(b). These are: · to search the premises and anything on the premises; · to inspect, examine, take measurements of, conduct tests on, or take samples of, any SSBA on the premises; · to take photographs, make video or audio recordings or make sketches of the premises or any thing on the premises; · if the inspector was authorised to enter the premises by a monitoring warrant, to require any person in or on the premises to answer any questions put by the inspector, and to produce any requested book, record or document. A person must not refuse or fail to comply with such a requirement. To do so attracts a maximum penalty of 30 penalty units; · to inspect any book, record or document on the premises; · to take extracts from or make copies of any such book, record or document; · to take onto premises such equipment and materials as the inspector requires for the purpose of exercising powers in relation to the premises; · to secure a thing, until a warrant is obtained to seize it, being a thing that the inspector finds during the exercise of monitoring powers on the premises, that the inspector believes on reasonable grounds may afford evidence of the commission of an offence against this Part or the Crimes (Biological Weapons) Act 1976, and that the inspector believes on reasonable grounds would be lost, destroyed or tampered with before the warrant can be obtained; and · to operate electronic equipment, and do other things, at the premises as mentioned in clause 67. Clause 67 - Power to operate equipment This clause provides that an inspector may operate equipment and disks, tapes or other storage devices at the premises to see whether it contains information that is relevant to 37

determining whether there has been compliance with the legislation (including any SSBA Standards). If the inspector finds such material, the inspector may: · operate facilities at the premises to put the information in documentary form and copy the document so produced; or · if the information can be transferred to a tape, disk or other storage device that is brought to the premises (or is at the premises and the occupier has agreed in writing to its use), operate the equipment or other facilities to copy the information to the storage device, and remove the storage device from the premises. Clause 68 - Compensation for damage to electronic equipment This clause provides that if damage is caused to a thing (including damage to, for example, data recorded on equipment) as a result of it being operated as mentioned in clause 67, and the damage resulted from insufficient care being exercised by the inspector either in selecting the person to operate the equipment or by the person operating it, compensation is payable to the owner. Compensation is payable from money appropriated by the Parliament, and is the amount agreed between the Commonwealth and the owner (or determined by the Federal Court of Australia or the Federal Magistrates Court if agreement can not be reached and the owner institutes proceedings). In determining the amount payable, regard is to be had as to whether the occupier (or their employees or agents) had provided any warning or guidance on the operation of the thing. This may, for example, minimise compensation in cases where there has been a deliberate programming of software to destroy or cause damage if not accessed in a particular manner, or where the occupier failed to mitigate damage by providing warning or guidance. Clause 69 - Application for monitoring warrant An inspector may apply to a magistrate for a monitoring warrant in relation to premises. The magistrate may issue the monitoring warrant if the magistrate is satisfied, by information on oath or affirmation, that it is reasonably necessary that one or more inspectors should have access to the premises: · to find out whether this Part, or regulations made for the purposes of this Part, or the SSBA Standards, have been complied with; or · to verify that the information given to the Secretary by an entity under clauses 42, 44, 48 or 49 is accurate and up-to-date. However, the magistrate must not issue the monitoring warrant unless the inspector or some other person has given to the magistrate, either orally or by affidavit, such further information (if any) as the magistrate requires concerning the grounds on which the issue of the warrant is being sought. 38

The monitoring warrant must: · authorise one or more inspectors (whether or not named in the warrant) with such assistance and by such force as is necessary and reasonable, to enter the premises and to exercise the powers set out in clause 66 in relation to the premises; and · state whether the entry is authorised to be made at any time of the day or night, or during specified hours; and · specify the day (not more than 6 months after the issue of the warrant) on which the warrant ceases to have effect; and · state the purpose for which the warrant is issued. An inspector must not make, in an application for a monitoring warrant, a statement that the inspector knows to be false or misleading in a material particular. The maximum penalty for this is imprisonment for 2 years, or 120 penalty units. Subdivision C--Offence-related powers Clause 70 - Searches related to offences This clause sets out the powers of an inspector who enters and conducts searches of premises in relation to evidence of the commission or suspected commission of an offence, and the circumstances under which those powers may be exercised. The Bill does not provide for the issue of offence-related warrants. If such a warrant is required, the matter may be referred to relevant authorities for investigation. This clause does, however, provide offence related powers which may be exercised by inspectors appointed under the Bill where they enter premises with consent. The powers may be exercised if an inspector has reasonable grounds for suspecting that there may be evidential material on any premises (related to offences under Part 3 of the Bill or under the Crimes (Biological Weapons) Act 1976). In these circumstances, the inspector may enter the premises, with the consent of the occupier, and exercise the following powers: · to search the premises and any thing on the premises for the evidential material; · to inspect, examine, take measurements of, conduct tests on, or take samples of the evidential material; · to take photographs, make video or audio recordings or make sketches of the premises or the evidential material; · to take onto the premises such equipment and materials as the inspector requires for the purpose of exercising powers in relation to the premises; and · to require any person in or on the premises to answer any questions put by the inspector and to produce any requested book, record or document. An inspector may also operate equipment at the premises in the pursuit of evidential material, if the inspector reasonably believes that the equipment can be operated without damage to the equipment. If the inspector finds that evidential material is accessible by operating the equipment and the material can be transferred to a storage device (that is brought to the premises, or is at the premises and the occupier has agreed in writing to its 39

use), the inspector may copy the material to the storage device and take the storage device from the premises. Subdivision D--Expert assistance Clause 71 - Expert assistance to operate a thing This clause provides that an inspector may secure a thing (for example, certain equipment) by locking it up or guarding it, if he or she believes on reasonable grounds that evidential material (or information relevant to determining compliance with the legislation and SSBA Standards) may be accessible by operating the thing at the premises, but that expert assistance is needed to operate the thing, and the evidential material may be destroyed or interfered with if the thing is not secured in the meantime. This provision is necessary to ensure that where, for example, the equipment is more sophisticated than expected, and cannot be accessed or moved, the opportunity to obtain expert assistance and to preserve evidential material is not lost. The clause allows the thing to be secured for either 24 hours or until the thing is operated by an expert, whichever happens first. Notice must be given to the occupier in all such cases. An inspector may apply to a Magistrate for an extension of the time needed for securing the equipment if he or she believes, on reasonable grounds, that the expert assistance will not be available within the 24 hour period. If this is the case, the occupier must be given notice that the inspector intends to apply for an extension. The occupier also has a right to be heard in relation to the application. Clause 72 - Expert assistance from scientific or technical expert This clause provides that an inspector may authorise a person with scientific or technical knowledge or expertise to assist the inspector. The inspector must believe that such assistance is necessary to ensure the safety of the inspector and any other person while the inspector is exercising powers of inspection. This clause only applies if an inspector has reasonable grounds for suspecting that there may be on any premises, evidential material or a particular thing that is not compliant with the legislation (including any regulations) or SSBA Standards. Subdivision E--Emergency powers Clause 73 - Powers available to inspectors for dealing with dangerous situations This clause describes the circumstances in which an inspector may exercise powers for dealing with dangerous situations. Dangerous situations exist where the inspector has reasonable grounds for suspecting that there may be, on any premises, a particular thing in respect of which there has not been compliance with the requirements of this Part (or relevant regulations or the SSBA Standards) and where the inspector considers it is 40

necessary to exercise the powers under this clause to avoid an imminent risk of death, serious illness, serious injury or to protect the environment. In such circumstances, an inspector may, without a warrant or the consent of an occupier: · enter premises; · search the premises for the thing; · secure the thing until a warrant is obtained to seize the thing; · if the inspector has reasonable grounds for suspecting that a person has failed to comply with the legislation or SSBA Standards, require the person to take such steps as the inspector considers necessary for compliance; and · take such steps in relation to the thing as the inspector considers appropriate. The inspector must, however, only exercise their powers to the extent necessary for the purposes of avoiding an imminent risk of death, serious illness, serious injury or serious damage to the environment. Further, the inspector must not exercise any of the powers in relation to premises unless the inspector has notified a relevant State or Territory emergency response agency of the inspector's intention to exercise those powers. If the Secretary incurs costs because of steps reasonably taken or arranged to be taken by an inspector, the person is liable to pay to the Commonwealth an amount equal to the costs, and the amount may be recovered by the Commonwealth as a debt due to the Commonwealth. Subdivision F--Obligations and incidental powers of inspectors Clause 74 - Inspector must produce identity card on request This clause makes it clear that an inspector cannot exercise any of the powers under this Division in relation to premises unless he/she produces his/her identity card, upon request by the occupier of those premises. Clause 75 - Consent This clause provides that, before obtaining consent from a person to enter premises, the inspector must inform the person that he or she may refuse consent. Any consent given by a person to enable entry to premises by the inspector must be voluntary. Clause 76 - Details of warrant to be given to occupier etc. This clause provides that, if a warrant in relation to premises is being executed, a copy of the warrant must be made available to the occupier of the premises or another person who represents the occupier, if they are present at the premises. The copy of the warrant need not include the signature of the Magistrate who issued the warrant. The inspector responsible for the execution of the warrant must identify himself or herself. Clause 77 - Announcement before entry This clause provides that, before an inspector enters premises under a warrant, he or she must announce that they are authorised to enter and give any person at the premises an opportunity to allow entry to the premises. The exceptions are where the inspector 41

believes on reasonable grounds that immediate entry is required to ensure the safety of a person or to prevent serious damage to the environment, or so that the effective execution of the warrant is not frustrated. Subdivision G--Other matters Clause 78 - Occupier entitled to be present during search If a monitoring warrant in relation to premises is being executed and the occupier of the premises (or another person who apparently represents the occupier) is present at the premises, then this clause provides that the person is entitled to observe the search being conducted. This right ceases if the person impedes the search. The clause also makes it clear that this does not prevent two or more areas of the premises being searched at the same time. Clause 79 - Division not to abrogate privilege against self incrimination This clause clarifies that nothing in the Division affects the right of a person to refuse to answer a question, give information, or produce a document on the grounds that the answer to the question, the information or the production of the document, might tend to incriminate him or her, or make him or her liable to a penalty. DIVISION 8--REVIEW OF DECISIONS Clause 80 - Meaning of reviewable decision This clause sets out the meaning of `reviewable decision' for the purpose of the Division. Reviewable decisions may be subject to internal review by the Secretary under clause 82, and review by the Administrative Appeals Tribunal under clause 83. A reviewable decision means: · a decision under sub-clause 45(2), 50(2), 53(3) or 57(4) to give a direction to an entity requiring the entity to dispose of a SSBA; or · a decision under sub-clause 59(2) to give a notice to an individual directing the individual not to handle SSBA as specified in the notice. Clause 81 - Notification of decision and review rights This clause provides that the Secretary must, as soon as practicable after making a reviewable decision, give the entity whose interests are affected by the decision a notice in writing containing the terms of the decision, the reasons for the decision and a statement setting out the entity's review rights. If the Secretary fails to comply with these requirements, this does not affect the validity of the decision. Clause 82 - Internal review This clause provides for internal review of reviewable decisions because the Secretary may, under clause 94 delegate the making of a reviewable decision. 42

The clause provides that an entity whose interests are affected by a reviewable decision (other than a decision made by the Secretary personally) may apply in writing to the Secretary for internal review of the decision. Such an application must be made within 30 days after the day on which the decision first came to the notice of the applicant, or within such period (if any) as the Secretary allows. The Secretary must, on receiving an application, review the reviewable decision personally, and may make a decision affirming, varying or revoking the reviewable decision. If the Secretary revokes the decision, the Secretary may make such other decision as the Secretary thinks appropriate. Clause 83 - Review of decisions by Administrative Appeals Tribunal This clause allows (subject to the Administrative Appeals Tribunal Act 1975) an application to be made to the Administrative Appeals Tribunal for a review of: · a reviewable decision made by the Secretary personally; or · a decision made by the Secretary under clause 82 (which provides for internal review). The word `decision' within this clause has the same meaning as in the Administrative Appeals Tribunal Act 1975. DIVISION 9--CONFIDENTIALITY OF INFORMATION Clause 84 - Definition of protected information Given the public safety and security considerations applying to certain information provided by entities under this Part, the Bill requires that such information be protected and, apart from limited exceptions, be used only for the purposes of the Part. This clause sets out the definition of protected information for the purposes of the Part. Protected information is information that was obtained under or for the purposes of, or in accordance with, this Part and that: · is included on the National Register; or · was given to the Secretary by an entity under Division 5; or · was obtained by an inspector under Division 7; or · is personal information. Clauses 85 to 89 authorise certain conduct in relation to protected information The conduct referred to in clauses 85 to 89 is authorised for the purposes of other laws, and the offence provision at clause 90 does not apply where protected information is dealt with in accordance with the authorisations. However, for the purpose of the offence at clause 90 the onus is on the defendant to show that they dealt with protected information in accordance with an authorisation. Clause 85 - Secretary may give report to prescribed agencies This clause authorises the Secretary to give a report to intelligence or law enforcement agencies that are prescribed by regulations, or to any Commonwealth, State or Territory 43

agency with responsibility for responding to emergencies, in order to enable those agencies to assess the security risks posed in relation to SSBA, and take action in relation to those risks. It is clarified that for the purposes of this clause security risk includes the possibility that a release of a SSBA may be a public health risk or may cause damage to the environment. Such a report may include protected information (as defined in clause 84). A note in this clause refers to the fact that it constitutes an authorisation for the purposes of other laws, such as paragraph (1)(d) of Information Privacy Principle 11 in section 14 of the Privacy Act 1988 or similar laws in the States and Territories. Clause 86 - Authorisation to use information in performing duties or exercising powers under Division 6, 7 or 8 of Part 2 or this Part This clause authorises a person to make a record of, disclose, or otherwise use protected information in the performance of the person's functions or duties, or the exercise of the person's powers, under Division 6, 7 or 8 of Part 2 or under this Part. A note in this clause refers to the fact that it constitutes an authorisation for the purposes of other laws, such as paragraph (1)(d) of Information Privacy Principle 11 in section 14 of the Privacy Act 1988 or similar laws in the States and Territories. Clause 87 - Authorisation to use information for certain purposes An intelligence or law enforcement agency, or an agency with responsibility for responding to emergencies, that obtains information under clause 85 may record, disclose or otherwise use the protected information provided by the Secretary in order to assess the security risks posed in relation to SSBA, and take action in relation to those risks. Any person to whom protected information is disclosed: · by an agency that obtained it from the Secretary, or · by another person who is authorised to disclose information under this clause, may record, disclose or otherwise use the protected information in order to assess the security risks posed in relation to SSBA, and take action in relation to those risks. A note in this clause refers to the fact that it constitutes an authorisation for the purposes of other laws, such as paragraph (1)(d) of Information Privacy Principle 11 in section 14 of the Privacy Act 1988 or similar laws in the States and Territories. Clause 88 - Secretary may authorise use of information This clause authorises a person to make a record of, disclose, or otherwise use protected information in accordance with a written authorisation issued by the Secretary of the Department of Health and Ageing. The authorisation may allow a person to make a record of (or use) protected information for a specified purpose or to disclose protected information to a specified person (or to a specified class of persons) for a specified purpose. 44

A note in this clause refers to the fact that it constitutes an authorisation for the purposes of other laws, such as paragraph (1)(d) of Information Privacy Principle 11 in section 14 of the Privacy Act 1988 or similar laws in the States and Territories. Clause 89 - Authorisation to use information for purposes of certain proceedings This clause authorises: · the disclosure of the information to a court, tribunal or coronial inquiry, or in accordance with an order of a court, tribunal or coroner, for the purposes of proceedings under this Part of the Act, the Crimes (Biological Weapons) Act 1976, Part 5.3 of the Criminal Code, or any other prescribed law of the Commonwealth or of a State or Territory; · a person who obtains protected information through the circumstances detailed above to make the record, or disclose or otherwise use the protected information for the purposes for which the information was disclosed. The intention of the Bill is to restrict those proceedings in which the security sensitive information gathered under this Bill is used. There is a capacity to prescribe other laws for which protected information may be disclosed to a court, tribunal or coronial inquiry. However, the breadth of disclosures authorised under this provision is intended to remain narrow. The notes in this clause alert the reader to the fact that: · it constitutes an authorisation for the purposes of other laws, such as paragraph (1)(d) of Information Privacy Principle 11 in section 14 of the Privacy Act 1988 or similar laws in the States and Territories; and · the National Security Information (Criminal and Civil Proceedings) Act 2004 may apply to proceedings under this Part. Clause 90 - Offence relating to protected information A person commits an offence if the person obtains protected information and makes a record of, discloses, or otherwise uses the information. The maximum penalty for this offence is imprisonment for 2 years. However, the offence does not apply if the record, disclosure or other use is authorised by this Division. A note in this clause clarifies that a defendant bears an evidential burden in relation to the authorisations referred to in this clause (see subsection 13.3(3) of the Criminal Code). Clause 90 also provides that a document that contains protected information is an exempt document for the purposes of section 38 of the Freedom of Information Act 1982. This means that the document is not subject to disclosure under the Freedom of Information Act 1982. Clause 91 - Defence for disclosure to person who provided the information This clause provides that the offence described in clause 90 does not apply if a person obtains protected information from another person and then discloses that information 45

back to the other person. This may occur, for example, where a person requests a copy of a document that has become protected information since it was provided under Part 3 of the Bill to an inspector or the Secretary. A note at the end of the clause clarifies that a defendant bears an evidential burden in relation to the matters in this clause (see subsection 13.3(3) of the Criminal Code). Clause 92 - Defence for use of information under particular laws This clause provides that the offence in clause 90 does not apply if the record, disclosure or other use of the information is required or authorised under: · this Part; · the Crimes (Biological Weapons) Act 1976; · Part 5.3 of the Criminal Code; · Part VIA of the Privacy Act 1988; or · any other prescribed law of the Commonwealth or of a State or Territory. Clause 92 provides for the prescription of other laws which may require the recording, disclosure or other use of protected information. However, it is intended that the laws which may require recording, disclosure or other use of protected information remain narrowly confined. Notes in the clause clarify that a defendant bears an evidential burden in relation to the relevant matters (as per subsection 13.3(3) of the Criminal Code) and the National Security Information (Criminal and Civil Proceedings) Act 2004 may apply to proceedings under the Part. Clause 93 - No other exceptions under other laws Commonwealth, State and Territory laws (other than those listed in clause 92) have no effect to the extent that they require or permit a person to record, disclose or otherwise use protected information where such use would contravene, or not be permitted by, a provision of this Division. This is regardless of when the law concerned is enacted. Division 10--Delegation Clause 94 - Secretary may delegate powers and functions under this Part This clause provides that the Secretary may, by writing, delegate any of his or her powers and functions under Part 3 to a Senior Executive Service (SES) employee, or an acting SES employee, in the Department. The exception to this is that the Secretary must not delegate the Secretary's power under clause 63 (appointment of inspectors). PART 4--MISCELLANEOUS Clause 95 - Regulations This clause enables the Governor General to make regulations for the purposes of this legislation. 46

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