Commonwealth: National Health Security Act 2007 (Cth)

National Health Security Act 2007 No. 174, 2007 Compilation No. 19 Compilation date: 14 October 2024 Includes amendments: Act No. 38, 2024 About this compilation This compilation This is a compilation of the National Health Security Act 2007 that shows the text of the law as amended and in force on 14 October 2024 (the compilation date). The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law. Uncommenced amendments The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law. Application, saving and transitional provisions for provisions and amendments If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes. Editorial changes For more information about any editorial changes made in this compilation, see the endnotes. Modifications If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law. Self‑repealing provisions If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes. Contents Part 1—Preliminary 1 Short title 2 Commencement 3 Definitions 4 Binding the Crown 5 Application of laws to external Territories Part 2—Public health surveillance Division 1—Objects of Part 6 Objects of Part Division 2—National Health Security Agreement 7 National Health Security Agreement Division 3—Permissible purposes 8 Permissible purposes Division 4—National Focal Point 9 Meaning of National Focal Point 10 Functions of the National Focal Point Division 5—National Notifiable Disease List 11 National Notifiable Disease List 12 Temporary additions to the National Notifiable Disease List Division 6—Notification, sharing information and liaising in relation to public health events of national significance and listed human diseases 13 Notification, sharing information and liaising in relation to public health events of national significance and listed human diseases 14 Receipt of information or recommendation from the World Health Organization 15 Non‑personal information Division 7—Public health observation 16 National Focal Point notified of incoming traveller who is under public health observation 17 Incoming travellers who are placed under public health observation Division 8—Confidentiality of information 18 Definition of protected information for the purposes of Part 2 19 Authorisation to use information for permissible purposes 20 Authorisation to use information for purposes of proceedings 21 Offence relating to protected information 22 Defence for use of information in good faith 23 Defence for use of information also received from another source and use of information by prescribed agencies 24 Defence for use of information required by another law 25 Defence for disclosure to person to whom information relates or if person to whom information relates consents 26 Defence for disclosure to person who provided the information Division 9—Miscellaneous 27 Notice to other countries about further use of information 28 Delegation 29 Annual report Part 3—Regulation of security‑sensitive biological agents Division 1—Preliminary 30 Object of Part Division 2—The List of Security‑sensitive Biological Agents 31 Establishment of the List of Security‑sensitive Biological Agents 32 Variation of the List of Security‑sensitive Biological Agents 33 Minister must obtain and have regard to expert advice 34 List to be available on the Department's website Division 3—Standards relating to security‑sensitive biological agents 35 Minister may determine standards relating to security‑sensitive biological agents Division 4—The National Register 36 National Register of Security‑sensitive Biological Agents 37 Content of National Register 38 Variation of the National Register Division 4A—Requirements relating to suspected security‑sensitive biological agents Subdivision A—Application 38A Application of Division Subdivision B—Carrying out confirmatory testing or destruction 38B Initial tester must have confirmatory testing or destruction done 38C Offence—failure to have confirmatory testing or destruction done Subdivision C—Compliance with SSBA standards 38D Compliance with SSBA Standards in handling biological agent 38E Offence—failure to comply with SSBA Standards in handling biological agent Subdivision D—Further provisions relating to confirmatory testing 38F Initial tester must report transfer of biological agent or sample for confirmatory testing 38G Offence—failure by initial tester to report transfer 38H Initial tester must report results of confirmatory testing to Secretary 38J Offence—failure to report results of confirmatory testing to Secretary 38K Reporting if biological agent disposed of after confirmatory testing shows it is a security‑sensitive biological agent 38L Offence—failure to report disposal Subdivision E—Further provisions relating to destruction 38M Initial tester must report destruction of biological agent 38N Offence—failure to report destruction 38P Direction to dispose of biological agent for failure to comply with section 38B 38Q Offence—failure to dispose of biological agent as directed Division 5—Requirements for entities that handle security‑sensitive biological agents Subdivision A—Application and definitions 39 Application of Division 40 Meaning of exempt entity 41 Meaning of legitimate purpose Subdivision B—Reporting requirements 42 Entity that handles security‑sensitive biological agents must give a report to the Secretary 43 Offence—failure to give a report to the Secretary 44 Secretary must consider report and decide whether or not to include entity on the National Register 45 Secretary may direct entity to dispose of security‑sensitive biological agents 46 Offence—failure to comply with direction to dispose of security‑sensitive biological agent 47 Secretary not satisfied entity handling security‑sensitive biological agent for a legitimate purpose 48 Registered entity must report any changes to the Secretary 48A Registered entity must report certain reportable events to police 48B Offence—failure to report reportable event to police 49 Secretary must consider report of changes and decide whether or not to vary the National Register 50 Secretary may direct entity to dispose of security‑sensitive biological agents 51 Offence—failure to comply with direction to dispose of security‑sensitive biological agent 52 Secretary not satisfied entity handling security‑sensitive biological agent for a legitimate purpose 53 Failure to report changes to the Secretary 54 Offence—failure to comply with direction to dispose of security‑sensitive biological agent 55 Application of reporting requirements in relation to individuals 55AA Entity that needs to undertake emergency maintenance may give a report to the Secretary 55AB Emergency maintenance period 55AC Secretary may declare exemption from this Division etc. during emergency maintenance period 55AD Offence—breaching condition of exemption 55A Cancellation of entity's registration on application Subdivision C—Compliance with SSBA Standards 56 Entity must comply with SSBA Standards 57 Failure to comply with SSBA Standards 58 Offence—failure to comply with direction to dispose of security‑sensitive biological agent Subdivision D—Directions not to handle security‑sensitive biological substances 59 Secretary may direct individual not to handle security‑sensitive biological agents 60 Offence—failure to comply with direction not to handle security‑sensitive biological agents Division 5AA—Entities that temporarily handle security‑sensitive biological agents Subdivision A—Reporting by entities that temporarily handle security‑sensitive biological agents 60AA Entity that temporarily handles a security‑sensitive biological agent may give a report to the Secretary 60AB Temporary handling period 60AC Application of Division 5 to an entity that gives a temporary handling report 60AD Entity that gives a temporary handling report must give a temporary handling disposal report 60AE Offence—failure to give a report to the Secretary 60AF Entity that gives a temporary handling report must report any changes to the Secretary 60AG Offence—failure to give a report to the Secretary 60AH Entity that gives a temporary handling report must report certain events to police 60AI Offence—failure to report event to police Subdivision B—Compliance with temporary handling Standards 60AJ Temporary handling Standards 60AK Entity must comply with temporary handling Standards 60AL Offence—failure to comply with temporary handling Standards Subdivision C—Conditions in relation to the temporary handling of security‑sensitive biological agents 60AM Secretary may impose conditions 60AN Entity must comply with conditions 60AO Failure to comply with conditions 60AP Offence—failure to comply with direction to dispose of sample Division 5A—Suspension of Divisions 4A, 5 and 5AA to deal with threats 60A Minister may suspend Divisions 4A, 5 and 5AA to deal with threats 60B Variation or revocation of suspension 60C Offence—failure to comply with conditions on suspension Division 6—Enforcement 61 Secretary may arrange for disposal of security‑sensitive biological agents 62 Injunctions Division 7—Powers of inspection Subdivision A—Appointment of inspectors and identity cards 63 Appointment of inspectors 64 Identity card Subdivision B—Monitoring compliance 65 Powers available to inspectors for monitoring compliance 66 Monitoring powers 67 Power to operate equipment 69 Application for monitoring warrant Subdivision C—Offence‑related powers 70 Inspector may enter premises by consent or under a warrant 70A Offence‑related powers of inspectors 70B Persons assisting inspectors 70C Use of force in executing a warrant 70D Inspector may ask questions and seek production of documents 70E Inspector to be in possession of warrant 70F Occupier to provide inspector with facilities and assistance 70G Copies of seized things to be provided 70H Receipts for things seized 70J Return of seized things 70K Magistrate may permit a thing to be retained 70L Disposal of things 70M Issue of offence‑related warrants 70N Offence‑related warrants by telephone, fax etc. 70P Offence relating to warrants by telephone, fax etc. Subdivision D—Expert assistance 71 Expert assistance to operate a thing 72 Expert assistance from scientific or technical expert Subdivision E—Emergency powers 73 Powers available to inspectors for dealing with dangerous situations Subdivision F—Obligations and incidental powers of inspectors 74 Inspector must produce identity card on request 75 Consent 76 Details of warrant etc. to be given to occupier 77 Announcement before entry Subdivision G—Other matters 78 Occupier entitled to be present during search 79 Division not to abrogate privilege against self‑incrimination 79A Compensation for damage to electronic equipment Division 8—Review of decisions 80 Meaning of reviewable decision 81 Notification of decision and review rights 82 Internal review 83 Review of decisions by Administrative Review Tribunal Division 9—Confidentiality of information 84 Definition of protected information for the purposes of Part 3 85 Secretary may give report to certain agencies 86 Authorisation to use information in performing duties or exercising powers under Division 6, 7 or 8 of Part 2 or this Part 87 Authorisation to use information for certain purposes 88 Secretary may authorise use of information 89 Authorisation to use information for purposes of certain proceedings 90 Offence relating to protected information 91 Defence for disclosure to person who provided the information 92 Defence for use of information under particular laws 93 No other exceptions under other laws Division 10—Delegation 94 Secretary may delegate powers and functions under this Part Part 4—Miscellaneous 95 Regulations Endnotes Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history An Act to provide for national health security, and for related purposes Part 1—Preliminary 1 Short title This Act may be cited as the National Health Security Act 2007. 2 Commencement (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms. Commencement information Column 1 Column 2 Column 3 Provision(s) Commencement Date/Details 1. Sections 1 to 5 and anything in this Act not elsewhere covered by this table The day on which this Act receives the Royal Assent. 28 September 2007 2. Part 2 A single day to be fixed by Proclamation. 28 March 2008 However, if any of the provision(s) do not commence within the period of 6 months beginning on the day on which this Act receives the Royal Assent, they commence on the first day after the end of that period. 3. Part 3 A day or days to be fixed by Proclamation. 31 January 2009 However, if any of the provision(s) do not commence within the period of 18 months beginning on the day on which this Act receives the Royal Assent, they commence on the first day after the end of that period. (see F2008L04297) 4. Part 4 The day on which this Act receives the Royal Assent. 28 September 2007 Note: This table relates only to the provisions of this Act as originally passed by both Houses of the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent. (2) Column 3 of the table contains additional information that is not part of this Act. Information in this column may be added to or edited in any published version of this Act. 3 Definitions (1) In this Act: Australia, when used in a geographical sense, includes the external Territories. Australian means an Australian citizen or a permanent resident. Australian territory has the meaning given by section 12 of the Biosecurity Act 2015. biological agents includes: (a) bacteria and viruses; and (b) toxins derived from biological sources, including animals, plants and microbes. coronial inquiry means a coronial inquiry, coronial investigation or coronial inquest under a law of the Commonwealth, or of a State or Territory. disease means an illness or medical condition (other than an injury), irrespective of origin or source, that presents or could present significant harm to humans. dispose of a biological agent means the transfer or destruction of the biological agent. emergency maintenance of a facility has the meaning given by subsection 55AA(1). emergency maintenance period for an emergency maintenance report has the meaning given by section 55AB. emergency maintenance report for a facility has the meaning given by subsection 55AA(2). enactment means: (a) an Act of the Commonwealth, a State or a Territory; or (b) an instrument (including rules, regulations and by‑laws) made under an Act of the Commonwealth, a State or a Territory. entity means any of the following: (a) an individual; (b) a body corporate; (c) an agency or instrumentality of the Commonwealth, a State or a Territory. event, for the purposes of Part 2, means: (a) an occurrence of disease, injury or death; or (b) an occurrence, including the release of a chemical, biological or radiological agent, that creates the potential for disease, injury or death. evidential material means any of the following: (a) a thing with respect to which an offence against Part 3 of this Act, or the Crimes (Biological Weapons) Act 1976, has been committed or is suspected, on reasonable grounds, to have been committed; (b) a thing that there are reasonable grounds for suspecting will afford evidence as to the commission of any such offence; (c) a thing that there are reasonable grounds for suspecting is intended to be used for the purpose of committing any such offence. exempt entity has the meaning given by section 40. facility includes: (a) a building, or part of a building; and (b) a laboratory (including a mobile laboratory). handling a biological agent includes: (a) receiving, holding, using and storing the biological agent; and (b) any operation incidental to, or arising out of, any of those operations. Note 1: Subsection 39(2) affects when an entity is treated for the purposes of Division 5 of Part 3 as handling a security‑sensitive biological agent that is a toxin. Note 2: An entity that handles a biological agent only for the purpose of transporting it from one place to another place is exempt from the requirements of Division 5 of Part 3: see subsection 40(1). inspector means a person appointed as an inspector under section 63. intelligence agency means a Commonwealth government agency that has responsibility for intelligence gathering or security. International Health Regulations means the International Health Regulations 2005, done at Geneva on 23 May 2005, as in force for Australia from time to time. Note: In 2007, the text of the International Health Regulations was accessible through the Australian Treaties Library on the AustLII website (www.austlii.edu.au). legitimate purpose, for an entity to handle a security‑sensitive biological agent, has the meaning given by section 41. listed human disease has the meaning given by section 42 of the Biosecurity Act 2015. List of Security‑sensitive Biological Agents means the list established under section 31, as the list is in force from time to time. monitoring warrant means a warrant issued under section 69. National Focal Point has the meaning given by section 9. National Health Security Agreement means the agreement entered into by the Minister under section 7, as the Agreement is in force from time to time. National Notifiable Disease List means the list established under section 11, as the list is in force from time to time. National Register means the National Register of Security‑sensitive Biological Agents established under section 36, as the National Register is in force from time to time. offence‑related powers has the meaning given by section 70A. offence‑related warrant means: (a) a warrant issued by a magistrate under section 70M; or (b) a warrant signed by a magistrate under section 70N. overseas mass casualty means an event occurring overseas, if: (a) more than one person (whether an Australian or otherwise): (i) is affected by a disease, or is injured or dies; and (ii) needs to be repatriated, identified or treated, or needs to be brought to Australia for treatment; and (b) a responsible Commonwealth, State or Territory body is involved in responding to the event. permanent resident means a person who is, within the meaning of the Migration Act 1958, the holder of a permanent visa. permissible purpose has the meaning given by section 8. personal information has the same meaning as in the Privacy Act 1988. person assisting an inspector has the meaning given by section 70B. premises includes the following: (a) a facility; (b) a place (including an area of land); (c) any part of premises (including premises referred to in paragraphs (a) and (b)). protected information: (a) for the purposes of Part 2—has the meaning given by section 18; and (b) for the purposes of Part 3—has the meaning given by section 84. public health event of national significance means any of the following events: (a) one or more cases or potential cases of a disease listed on the National Notifiable Disease List; (b) an urgent event; (c) an overseas mass casualty; (ca) if a national emergency declaration (within the meaning of the National Emergency Declaration Act 2020) is in force—an emergency to which the declaration relates, if the emergency relates to public health; (d) a public health risk (other than an event covered by paragraph (a), (b), (c) or (ca)). public health observation means the monitoring of the health of a person for the purposes of determining the risk of transmission of a disease. public health risk means an event: (a) that might adversely affect the health of human populations; and (b) that satisfies any one or more of the following conditions: (i) the health effects of the event might spread within Australia; (ii) the health effects of the event might spread between Australia and another country; (iii) the health effects of the event might spread between 2 other countries; (iv) the event might present a serious and direct danger. register an entity means include the entity on the National Register in relation to one or more security‑sensitive biological agents handled by the entity at one or more facilities. registered entity means an entity that is registered under section 44 or 47. reportable event means an event referred to in subsection 48(1). reportable quantity, in relation to a toxin included in the List of Security‑sensitive Biological Agents, means the quantity (if any) specified in the list as the reportable quantity of that toxin. responsible Commonwealth, State or Territory body, when used in a provision of Part 2, means a body that is determined under subsection (2) to be a responsible Commonwealth, State or Territory body for the purposes of the provision of Part 2. reviewable decision, for the purposes of Division 8 of Part 3, has the meaning given by section 80. sample of a biological agent includes: (a) a subculture of the agent; and (b) a preparation made from the agent. Secretary means the Secretary of the Department. security‑sensitive biological agent means a biological agent that is included in the List of Security‑sensitive Biological Agents. SSBA means security‑sensitive biological agent. SSBA Standards means the standards determined by the Minister under section 35. State or Territory Health Minister means: (a) the Minister of a State; or (b) the Minister of the Australian Capital Territory; or (c) the Minister of the Northern Territory; who is responsible, or principally responsible, for the administration of matters relating to health in the State, the Australian Capital Territory or the Northern Territory, as the case may be. State Party means a State that is a signatory to the International Health Regulations. temporary handling disposal report for a sample of a security‑sensitive biological agent has the meaning given by subsection 60AD(2). temporary handling period for a sample of a security‑sensitive biological agent has the meaning given by section 60AB. temporary handling report for a sample of a security‑sensitive biological agent has the meaning given by subsection 60AA(1). temporary handling Standard has the meaning given by section 60AJ. traveller means a person undertaking a voyage in which the person enters, or will enter, a country other than the country from which the person began the voyage. urgent event means an event: (a) 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 (b) in respect of which any of the following applies: (i) the event has or might have a serious impact on public health; (ii) 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); (iii) 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). Note 1: For examples of events that might have a serious impact on public health, see the examples under question I of Annex 2 of the International Health Regulations ("Is the public health impact of the event serious?"). Note 2: For examples of events that are unusual or unexpected, see the examples under question II of Annex 2 of the International Health Regulations ("Is the event unusual or unexpected?"). (2) The Minister may, by legislative instrument, determine any of the following bodies to be a responsible Commonwealth, State or Territory body for the purposes of a provision of Part 2: (a) one or more bodies of the Commonwealth; (b) one or more bodies, nominated by a State or Territory Health Minister, of each State, the Australian Capital Territory and the Northern Territory. 4 Binding the Crown (1) This Act binds the Crown in right of the Commonwealth, of each of the States, of the Australian Capital Territory and of the Northern Territory. (2) This Act does not make the Crown liable to be prosecuted for an offence. 5 Application of laws to external Territories This Act extends to every external Territory. Part 2—Public health surveillance Division 1—Objects of Part 6 Objects of Part The objects of this Part are: (a) to provide a national system of public health surveillance to enhance the capacity of the Commonwealth and the States and Territories to identify, and respond to, public health events of national significance which include: (i) the occurrence of certain communicable diseases; or (ii) certain releases of chemical, biological or radiological agents; or (iii) the occurrence of public health risks; or (iv) the occurrence of overseas mass casualties; and (b) to provide for the sharing of information with: (i) the World Health Organization; and (ii) countries affected by an event relating to public health or an overseas mass casualty; and (c) to support the Commonwealth and the States and Territories in giving effect to the International Health Regulations (other than as mentioned in paragraphs (a) and (b)). Division 2—National Health Security Agreement 7 National Health Security Agreement (1) The Minister, on behalf of the Commonwealth, may enter into an agreement with the States, the Australian Capital Territory and the Northern Territory for any one or more of the following purposes: (a) providing for the sharing of information between the Commonwealth, the States and the Territories in relation to communicable diseases, in order to enhance: (i) the understanding of the epidemiology of those diseases; and (ii) the understanding of the threats of those diseases; and (iii) the ability within Australia to respond to those diseases; (b) formalising and enhancing consultation between the Commonwealth, the States and the Territories in relation to public health events of national significance; (c) enhancing the ability within Australia to identify and respond quickly to public health events of national significance; (d) facilitating the monitoring of public health events of national significance within Australia. (2) Subsection (1) does not, by implication, limit the executive power of the Commonwealth to enter into agreements. Note: This subsection allows the National Health Security Agreement to cover purposes other than those mentioned in subsection (1). Division 3—Permissible purposes 8 Permissible purposes For the purposes of this Part, each of the following is a permissible purpose: (a) preventing, protecting against, controlling or responding to a public health event of national significance (other than an overseas mass casualty); (b) giving effect to the International Health Regulations (other than as mentioned in paragraph (a)); (c) if an Australian suffers from a disease, or is injured or dies, as a result of an overseas mass casualty—facilitating: (i) the identification of the Australian (whether in Australia or overseas); and (ii) the repatriation of the Australian to Australia; and (iii) the treatment of the Australian (whether in Australia or overseas); (d) 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: (i) the identification of the person (whether within Australia or overseas); and (ii) bringing the person to Australia for treatment; and (iii) the treatment in Australia of the person; (e) preventing, or reducing the possibility of, a listed human disease entering, or emerging, establishing itself or spreading in, Australian territory or a part of Australian territory; (f) preventing a listed human disease from spreading to another country. Division 4—National Focal Point 9 Meaning of National Focal Point The National Focal Point means: (a) the Secretary; and (b) the persons, offices or positions (if any) nominated in writing by the Secretary for the purposes of this section. 10 Functions of the National Focal Point The functions of the National Focal Point are the following: (a) to liaise with responsible Commonwealth, State or Territory bodies in relation to public health events of national significance; (b) to liaise with and be accessible to the World Health Organization and States Parties at all times for the purposes of giving effect to the International Health Regulations; (c) to liaise with responsible Commonwealth, State or Territory bodies for the purposes of giving effect to the International Health Regulations; (d) any other functions given to the National Focal Point under: (i) this Act or the regulations; or (ii) any other Act. Division 5—National Notifiable Disease List 11 National Notifiable Disease List (1) The Minister must, by legislative instrument, establish a list of diseases, to be called the National Notifiable Disease List. (2) The Minister may include a disease in the list if the Minister considers that an outbreak of the disease would be a public health risk. (3) The Minister may vary the list by: (a) adding a disease if the Minister considers that an outbreak of the disease would be a public health risk; or (b) removing a disease if the Minister no longer considers that an outbreak of the disease would be a public health risk. (4) A variation under subsection (3) is a legislative instrument. (5) In making or varying the list, the Minister must consult: (a) the Commonwealth Chief Medical Officer; and (b) each State or Territory Health Minister. 12 Temporary additions to the National Notifiable Disease List (1) In addition to the Minister's power, under subsection 11(3), to vary the National Notifiable Disease List, the Minister or the Commonwealth Chief Medical Officer may vary the list by adding a disease if the Minister or the Commonwealth Chief Medical Officer (as the case requires) considers that an outbreak of the disease would be a public health risk. (2) A variation under subsection (1) is a legislative instrument. (3) If, under subsection (1), the Minister varies the list, the Minister is not required to consult: (a) the Commonwealth Chief Medical Officer; or (b) any State or Territory Health Minister. (4) At the end of the period of 6 months after the list is varied under subsection (1), the variation ceases to have effect unless the Minister has made a determination under subsection (6). (5) A particular disease may not be added to the list under subsection (1) more than once. (6) After consulting: (a) the Commonwealth Chief Medical Officer; and (b) each State or Territory Health Minister; the Minister may determine that the variation continues to have effect if the Minister considers that an outbreak of the disease that is included in the variation would be a public health risk. (7) A determination under subsection (6) is a legislative instrument. Division 6—Notification, sharing information and liaising in relation to public health events of national significance and listed human diseases 13 Notification, sharing information and liaising in relation to public health events of national significance and listed human diseases Public health events of national significance (other than overseas mass casualties) (1) The Minister may take action under subsection (2) if: (a) a responsible Commonwealth, State or Territory body gives the National Focal Point information relating to a public health event of national significance (other than an overseas mass casualty); and (b) the Minister considers that it is appropriate to take action under subsection (2) for a permissible purpose referred to in paragraph 8(a) or (b). (2) The Minister may: (a) notify any responsible Commonwealth, State or Territory body that is affected, or might be affected, by the event; and (b) give such bodies any relevant information that is available to the Minister in relation to the event; and (c) liaise with such bodies in relation to the event. Overseas mass casualties (3) The Minister may take action under subsection (4) if: (a) a responsible Commonwealth, State or Territory body gives the National Focal Point information relating to an overseas mass casualty; and (b) the Minister considers that it is appropriate to take action under subsection (4) for a permissible purpose referred to in paragraph 8(c) or (d). (4) The Minister may: (a) notify any responsible Commonwealth, State or Territory body that is affected, or might be affected, by the overseas mass casualty; and (b) give such bodies any relevant information that is available to the Minister in relation to the overseas mass casualty; and (c) liaise with such bodies in relation to the overseas mass casualty. Cases of listed human diseases (5) The Minister may take action under subsection (6) if: (a) a responsible Commonwealth, State or Territory body gives the National Focal Point information relating to one or more cases or potential cases of a listed human disease; or (b) the Minister considers that it is appropriate to take action under subsection (6) for a permissible purpose referred to in paragraph 8(e) or (f). (6) The Minister may: (a) notify any responsible Commonwealth, State or Territory body that is affected, or might be affected, by the case or potential case of the listed human disease; and (b) give such bodies any relevant information that is available to the Minister in relation to the case or potential case of the listed human disease; and (c) liaise with such bodies in relation to the case or the potential case of the listed human disease. 14 Receipt of information or recommendation from the World Health Organization (1) This section applies if the Minister receives: (a) a recommendation from the World Health Organization under Part III of the International Health Regulations; or (b) information provided by the World Health Organization, or any other State Party, under the International Health Regulations. (2) After receiving the recommendation or information, the Minister may: (a) inform one or more responsible Commonwealth, State or Territory bodies of the recommendation; or (b) give one or more responsible Commonwealth, State or Territory bodies the information. (3) The Minister may give to the World Health Organization, 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 World Health Organization. Note: 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: see subsection 27(1). 15 Non‑personal information This Division does not prevent the Minister from dealing with information: (a) that is referred to in this Division; but (b) that is not personal information; in a manner other than the manner set out in this Part. Division 7—Public health observation 16 National Focal Point notified of incoming traveller who is under public health observation If the National Focal Point is notified that a traveller who has entered, or will enter, Australia is under public health observation, then: (a) the National Focal Point must notify a responsible Commonwealth, State or Territory body to identify and make contact with the traveller; and (b) the body must identify and make contact with the traveller. 17 Incoming travellers who are placed under public health observation (1) This section applies if: (a) a traveller enters Australia; and (b) a responsible Commonwealth, State or Territory body places the traveller under public health observation; and (c) the traveller is in transit while in Australia; and (d) after leaving Australia, the traveller is travelling to a port or airport outside Australia. (2) The responsible Commonwealth, State or Territory body must notify the National Focal Point of the following information: (a) the name, address and date of birth of the person; (b) that the person is under public health observation; (c) the reason for the person being under public health observation; (d) 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; (e) 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 that port or airport; (f) any other information prescribed by the regulations for the purposes of this section. (3) If the person's first port or airport of arrival outside Australia is in a State Party, the National Focal Point must notify one of the following entities of the information referred to in subsection (2): (a) the first port or airport outside Australia; (b) if that is not reasonably practicable—the State Party's National IHR Focal Point (within the meaning of the International Health Regulations). Note: The National Focal Point must also give a notice specifying the purposes for which the information referred to in subsection (2) may be used: see subsection 27(1). (4) If the person's first port or airport of arrival outside Australia is not in a State Party, the National Focal Point may notify that port or airport of the information referred to in subsection (2). Note: The National Focal Point must also give a notice specifying the purposes for which the information referred to in subsection (2) may be used: see subsection 27(3). (5) The National Focal Point may notify the last port or airport outside Australia that the person left before arriving in Australia of the information referred to in subsection (2). Division 8—Confidentiality of information 18 Definition of protected information for the purposes of Part 2 In this Part: protected information is personal information that: (a) is obtained under, or in accordance with, this Part by the Minister or the National Focal Point; or (b) is obtained under, or in accordance with, this Part directly from the Minister or the National Focal Point; or (c) is derived from a record of the information made under, or in accordance with, this Part by the Minister or the National Focal Point; or (d) is derived from a disclosure or use of the information under, or in accordance with, this Part by the Minister or the National Focal Point. 19 Authorisation to use information for permissible purposes Use by persons in performing functions or duties or exercising powers (1) A person may do one or both of the following, in the performance of the person's functions or duties, or the exercise of the person's powers, for a permissible purpose: (a) disclose information (including personal information), on behalf of a responsible Commonwealth, State or Territory body, to the National Focal Point; (b) make a record of, or disclose or otherwise use, protected information in accordance with Division 6 or 7 of this Part. Note: This subsection constitutes an authorisation for the purposes of other laws, such as paragraph 6.2(b) of Australian Privacy Principle 6. (2) A person may make a record of, or disclose or otherwise use, protected information if: (a) the person is: (i) an officer or employee of the Commonwealth, a State, the Australian Capital Territory or the Northern Territory; or (ii) an officer or employee of an agency or instrumentality of the Commonwealth, a State, the Australian Capital Territory or the Northern Territory; or (iii) a person engaged by the Commonwealth, a State, the Australian Capital Territory or the Northern Territory, to perform public health work; or (iv) a person engaged by an agency or instrumentality of the Commonwealth, a State, the Australian Capital Territory or the Northern Territory, to perform public health work; and (b) the person makes the record of, or discloses or otherwise uses, the information: (i) in the performance of the person's functions or duties, or the exercise of the person's powers; and (ii) for a permissible purpose. Note: This subsection constitutes an authorisation for the purposes of other laws, such as paragraph 6.2(b) of Australian Privacy Principle 6. (3) In determining the scope of a person's functions, duties or powers for the purposes of subsection (1) or (2), disregard any provision of an enactment that restricts or prohibits the making of records, or the disclosure or use, of information. Use by Minister (4) The Minister may: (a) do any of following for the purpose of giving effect to the International Health Regulations: (i) disclose protected information to the World Health Organization or a State Party; (ii) make a record of or use protected information; and (b) do any of the following for the purpose of assisting other countries to prevent, protect against, control or respond to an event relating to public health: (i) disclose protected information to a country that is affected or might be affected by the event; (ii) make a record of or use protected information for the purpose of determining whether a country is affected by the event. Note 1: Examples of where Australia may disclose information to the World Health Organization include a disclosure for the purposes of Articles 6 to 10 of the International Health Regulations. For example, for the purposes of Articles 6, 7 and 10 of those Regulations, Australia may urgently need to notify the World Health Organization of, and give information about, events which might constitute a public health emergency of international concern. Note 2: This subsection constitutes an authorisation for the purposes of other laws, such as paragraph 6.2(b) of Australian Privacy Principle 6. Note 3: If the Minister discloses personal information to another country, the Minister must also give a notice specifying the purposes for which the information may be used: see section 27. Use by other persons (5) The Minister may, in writing, authorise a person: (a) to make a record of or use protected information for a permissible purpose that is specified in the authorisation; or (b) to disclose protected information to a specified person, or to a specified class of persons, for a permissible purpose that is specified in the authorisation. (6) A person who is authorised to make a record of, or disclose or otherwise use, protected information under subsection (5) may make a record of, or disclose or otherwise use, the information in accordance with the authorisation. Note: This subsection constitutes an authorisation for the purposes of other laws, such as paragraph 6.2(b) of Australian Privacy Principle 6. Use under this section not an offence under other laws (7) A person does not commit an offence, and is not liable to any penalty, under the provisions of any other enactment of the Commonwealth, or an enactment of a State or a Territory, as a result of the person making a record of, or disclosing or using, information in accordance with subsection (1), (2), (4) or (6). Use under this section does not result in liability for civil proceedings (8) 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 of, or disclosing or using, information in accordance with subsection (1), (2), (4) or (6). Use under this section does not contravene medical standards (9) A person does not contravene medical standards, or any other relevant professional standards, as a result of the person making a record of, or disclosing or using, information in accordance with subsection (1), (2), (4) or (6). 20 Authorisation to use information for purposes of proceedings (1) A person who obtains protected information for a permissible purpose may disclose the information: (a) to a court or tribunal, or in accordance with an order of a court or tribunal, for the purposes of proceedings; or (b) to a coronial inquiry, or in accordance with an order of a coroner, for the purposes of a coronial inquiry. Note 1: The National Security Information (Criminal and Civil Proceedings) Act 2004 may apply to proceedings under this Part. Note 2: This subsection constitutes an authorisation for the purposes of other laws, such as paragraph 6.2(b) of Australian Privacy Principle 6. (2) A person who obtains protected information under, or in accordance with, subsection (1) may make a record of, or disclose or otherwise use, the information for the purposes for which the information was disclosed under that subsection. Note: This subsection constitutes an authorisation for the purposes of other laws, such as paragraph 6.2(b) of Australian Privacy Principle 6. 21 Offence relating to protected information A person commits an offence if: (a) the person obtains information; and (b) the information is protected information; and (c) the person makes a record of, or discloses or otherwise uses, the information; and (d) the record, disclosure or use is not authorised by section 19 or 20. Penalty: Imprisonment for 2 years. Note: For defences to this offence, see sections 22 to 26. 22 Defence for use of information in good faith Section 21 does not apply if: (a) a person obtains protected information for a permissible purpose; and (b) the person makes a record of, or discloses or otherwise uses, the information in good faith: (i) in performing, or purportedly performing, his or her functions or duties under this Part on behalf of a responsible Commonwealth, State or Territory body; or (ii) in exercising, or purportedly exercising, his or her powers under this Part on behalf of a responsible Commonwealth, State or Territory body. Note: A defendant bears an evidential burden in relation to the matter in this section: see subsection 13.3(3) of the Criminal Code. 23 Defence for use of information also received from another source and use of information by prescribed agencies Use if information is also received from another source (1) Section 21 does not apply if: (a) a person (the first person) obtains protected information for a permissible purpose; and (b) the first person is: (i) an officer or employee of the Commonwealth, a State, the Australian Capital Territory or the Northern Territory; or (ii) an officer or employee of an agency or instrumentality of the Commonwealth, a State, the Australian Capital Territory or the Northern Territory; or (iii) a person engaged by the Commonwealth, a State, the Australian Capital Territory or the Northern Territory, to perform public health work; or (iv) a person engaged by an agency or instrumentality of the Commonwealth, a State, the Australian Capital Territory or the Northern Territory, to perform public health work; and (c) the first person also obtains the information, or substantially similar information, from another person; and (d) after obtaining the information as mentioned in paragraph (c), the first person makes a record of, or discloses or otherwise uses, the information; and (e) the record, disclosure or use is authorised under, or is not prohibited by: (i) another enactment of the Commonwealth; or (ii) an enactment of the State or the Territory in relation to which the person is an officer or employee, or is engaged to perform public health work. Note: A defendant bears an evidential burden in relation to the matter in subsection (1): see subsection 13.3(3) of the Criminal Code. Use by intelligence agencies (2) Section 21 does not apply if: (a) a person obtains protected information; and (b) the person discloses the information to an officer or employee of an intelligence agency prescribed by the regulations for the purposes of this section. Note: A defendant bears an evidential burden in relation to the matter in subsection (2): see subsection 13.3(3) of the Criminal Code. (3) Section 21 does not apply if: (a) a person obtains protected information in accordance with a disclosure under subsection (2); and (b) the person makes a record of, or discloses or otherwise uses, the information in the performance of the person's functions or duties, or the exercise of the person's powers, as an officer or employee mentioned in paragraph (2)(b). Note: A defendant bears an evidential burden in relation to the matter in subsection (3): see subsection 13.3(3) of the Criminal Code. (4) Section 21 does not apply if: (a) a person obtains protected information in accordance with a disclosure under subsection (3); and (b) the person makes a record of, or discloses or otherwise uses, the information: (i) for the purposes for which the information was disclosed under that subsection; or (ii) for a prescribed purpose. Note: A defendant bears an evidential burden in relation to the matter in subsection (3): see subsection 13.3(3) of the Criminal Code. 24 Defence for use of information required by another law Section 21 does not apply if: (a) a person obtains protected information for a permissible purpose; and (b) the person makes a record of, or discloses or otherwise uses, the information; and (c) the record, disclosure or use is required under another enactment of the Commonwealth, or of a State or Territory. Note: A defendant bears an evidential burden in relation to the matter in this section: see subsection 13.3(3) of the Criminal Code. 25 Defence for disclosure to person to whom information relates or if person to whom information relates consents Disclosure to person to whom information relates (1) Section 21 does not apply if: (a) a person (the first person) obtains protected information for a permissible purpose; and (b) the information relates to another person; and (c) the first person discloses the information to the other person. Note: A defendant bears an evidential burden in relation to the matter in subsection (1): see subsection 13.3(3) of the Criminal Code. (2) If subsection (1) applies in respect of information, then section 21 does not apply to any of the following: (a) any record of that information that is made by the person to whom the information relates; (b) any disclosure or use of that information by the person to whom the information relates; (c) 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 in paragraph (a) or (b). Note: A defendant bears an evidential burden in relation to the matter in subsection (2): see subsection 13.3(3) of the Criminal Code. Consent to disclosure etc. of information (3) Section 21 does not apply if: (a) a person (the first person) obtains protected information; and (b) 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 (c) the first person makes the record, or discloses or uses the information, for that purpose. Note: A defendant bears an evidential burden in relation to the matter in subsection (3): see subsection 13.3(3) of the Criminal Code. 26 Defence for disclosure to person who provided the information Section 21 does not apply if: (a) a person obtains protected information from another person; and (b) the person discloses that information to the other person. Note: A defendant bears an evidential burden in relation to the matter in this section: see subsection 13.3(3) of the Criminal Code. Division 9—Miscellaneous 27 Notice to other countries about further use of information (1) If, under Division 6, 7 or 8, the Minister or the National Focal Point gives personal information to a State Party for the purposes of giving effect to the International Health Regulations, the Minister or the National Focal Point must give the State Party, at the same time as giving the information, a written notice specifying that a record may be made of the information, or the information may be used or disclosed, only for the purposes of, and subject to the requirements of Article 45 of, the International Health Regulations. (2) If, under Division 8, the Minister gives personal information to a State Party but not for the purposes of giving effect to the International Health Regulations, the Minister must give the State Party, at the same time as giving the information, a written notice specifying the purposes for which: (a) a record may be made of the information; or (b) the information may be used or disclosed. (3) If, under Division 7 or 8, the Minister or the National Focal Point gives personal information to a country that is not a State Party, the Minister or the National Focal Point must give the country, at the same time as giving the information, a written notice specifying the purposes for which: (a) a record may be made of the information; or (b) the information may be used or disclosed. (4) To avoid doubt, personal information is given to another country if the information is given to a port or airport in the other country or to the other country's National IHR Focal Point (within the meaning of the International Health Regulations). 28 Delegation (1) The Minister may delegate any of his or her functions or powers under this Part to an SES employee, or an acting SES employee, of the Department. (2) In performing a delegated function or exercising a delegated power, a delegate must comply with any written directions of the Minister. 29 Annual report (1) 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 section 18) during the previous 12 months. (2) The report must be included in the annual report of the Department. Part 3—Regulation of security‑sensitive biological agents Division 1—Preliminary 30 Object of Part (1) The object of this Part is to give effect to Australia's obligations to establish controls for the security of certain biological agents that could be used as weapons. (2) To achieve this object, this Part provides for: (a) the collection of certain information about security‑sensitive biological agents and about biological agents suspected on the basis of testing in a laboratory of being security‑sensitive biological agents; and (aa) the recording on a national register of information about the nature and location of security‑sensitive biological agents legitimately handled by entities in Australia; and (b) requirements to be complied with for the secure handling of security‑sensitive biological agents and biological agents suspected on the basis of testing in a laboratory of being security‑sensitive biological agents; and (c) monitoring of compliance with reporting and handling requirements through an inspection program; and (d) restrictions in relation to the handling of security‑sensitive biological agents. Division 2—The List of Security‑sensitive Biological Agents 31 Establishment of the List of Security‑sensitive Biological Agents (1) The Minister must establish a list of biological agents that the Minister considers to be of security concern to Australia. The list is to be called the List of Security‑sensitive Biological Agents. (2) Without limiting subsection (1), 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. (3) 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. (4) The list is not a legislative instrument. 32 Variation of the List of Security‑sensitive Biological Agents (1) The Minister may, in writing, vary the List of Security‑sensitive Biological Agents by: (a) 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; or (b) 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; or (c) changing the reportable quantity of a biological agent in the list; or (d) correcting an inaccuracy. (2) An instrument varying the List of Security‑sensitive Biological Agents is not a legislative instrument. 33 Minister must obtain and have regard to expert advice (1) The Minister must not include a biological agent, or a reportable quantity of a biological agent, in the List of Security‑sensitive Biological Agents, or otherwise vary the list, unless: (a) the Minister has obtained advice from: (i) an 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; and (ii) persons with scientific or technical knowledge of biological agents that may be of security concern to Australia; and (b) the Minister has sought advice from the States, the Australian Capital Territory and the Northern Territory. (2) To avoid doubt, the persons referred to in subparagraph (1)(a)(ii) may be officers or employees of an agency or instrumentality of the Commonwealth referred to in subparagraph (1)(a)(i). (3) The Minister must have regard to advice received under subsection (1). 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 Security‑sensitive Biological Agents is available on the Department's website. Division 3—Standards relating to security‑sensitive biological agents 35 Minister may determine standards relating to security‑sensitive biological agents (1) The Minister may, by legislative instrument, determine standards (SSBA Standards) relating to security‑sensitive biological agents and biological agents that are or have been suspected, on the basis of testing in a laboratory, of being security‑sensitive biological agents. Note 1: SSBA Standards must be complied with by certain entities that handle or dispose of biological agents suspected of being security‑sensitive biological agents: see sections 38B and 38D. Note 2: SSBA Standards must be complied with by entities that handle security‑sensitive biological agents: see section 56. (2) Without limiting subsection (1), a standard may set out requirements relating to any of the following: (a) the storage of security‑sensitive biological agents; (b) the security status of individuals who are entitled to handle or dispose of security‑sensitive biological agents; (c) the transport of security‑sensitive biological agents; (d) the handling (including transport) of biological agents suspected, on the basis of testing in a laboratory, of being security‑sensitive biological agents; (e) the disposal of biological agents that are or have been suspected, on the basis of testing in a laboratory, of being security‑sensitive biological agents. (2A) An example of requirements relating to a matter described in paragraph (2)(b) is requirements for background checks of individuals to be conducted under the AusCheck scheme (within the meaning of the AusCheck Act 2007) for the purposes of determining whether they should be authorised to handle or dispose of security‑sensitive biological agents. (3) A standard may set out different requirements to be complied with in respect of different security‑sensitive biological agents. (3A) A standard may set out different requirements relating to a biological agent depending on whether the agent: (a) is merely suspected by a specified entity, on the basis of testing in a laboratory, of being a security‑sensitive biological agent; or (b) is a security‑sensitive biological agent (regardless of any entity's knowledge or ignorance of that fact); or (c) is known by a specified entity to be a security‑sensitive biological agent; or (d) is known by a specified entity to be a security‑sensitive biological agent and was previously suspected by a specified entity, on the basis of testing in a laboratory, of being a security‑sensitive biological agent. (4) The Minister must not determine a standard unless the standard has been developed in consultation with: (a) persons with scientific or technical knowledge in relation to the security of biological agents; and (b) the States, the Australian Capital Territory and the Northern Territory. (5) Subsection (4) does not prevent the Minister from consulting any other person who the Minister considers may assist the Minister in developing a standard. Division 4—The National Register 36 National Register of Security‑sensitive Biological Agents (1) There is to be a Register called the National Register of Security‑sensitive Biological Agents. (2) The National Register is to be maintained in an up‑to‑date form by the Secretary. (3) The National Register may be kept in a computerised form. Note: Information included on the National Register must not be disclosed except in accordance with Division 9. 37 Content of National Register If the Secretary decides, under section 44 or 47, to register an entity in relation to one or more security‑sensitive biological agents handled by the entity at one or more facilities, the Secretary must include the following particulars in the National Register: (a) the name of the entity; (b) the name and address of each facility where the entity handles security‑sensitive biological agents; (c) the name of each security‑sensitive biological agent handled by the entity at each facility; (d) the purpose for which each such security‑sensitive biological agent is handled by the entity; (e) if the decision is made under subsection 47(2) (which provides for registration on a temporary basis)—a statement to this effect; (f) such other particulars as are prescribed by the regulations. 38 Variation of the National Register (1) The Secretary must vary the National Register to take accoun