providing for the sharing of information between the Commonwealth, the States and the Territories in relation to communicable diseases, in order to enhance:

the understanding of the epidemiology of those diseases; and

the understanding of the threats of those diseases; and

the ability within Australia to respond to those diseases;

formalising and enhancing consultation between the Commonwealth, the States and the Territories in relation to public health events of national significance;

enhancing the ability within Australia to identify and respond quickly to public health events of national significance;

facilitating the monitoring of public health events of national significance within Australia.

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.

the Director-General of the CDC; and

each State or Territory Health Minister.

the Director-General of the CDC; or

any State or Territory Health Minister.

the Director-General of the CDC; and

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.

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

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).

notify any responsible Commonwealth, State or Territory body that is affected, or might be affected, by the event; and

give such bodies any relevant information that is available to the Minister in relation to the event; and

liaise with such bodies in relation to the event.

Overseas mass casualties

a responsible Commonwealth, State or Territory body gives the National Focal Point information relating to an overseas mass casualty; and

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).

notify any responsible Commonwealth, State or Territory body that is affected, or might be affected, by the overseas mass casualty; and

give such bodies any relevant information that is available to the Minister in relation to the overseas mass casualty; and

liaise with such bodies in relation to the overseas mass casualty.

Cases of listed human diseases

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

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).

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

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

liaise with such bodies in relation to the case or the potential case of the listed human disease.

a recommendation from the World Health Organization under Part III of the International Health Regulations; or

information provided by the World Health Organization, or any other State Party, under the International Health Regulations.

inform one or more responsible Commonwealth, State or Territory bodies of the recommendation; or

give one or more responsible Commonwealth, State or Territory bodies the information.

a traveller enters Australia; and

a responsible Commonwealth, State or Territory body places the traveller under public health observation; and

the traveller is in transit while in Australia; and

after leaving Australia, the traveller is travelling to a port or airport outside Australia.

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 that port or airport;

any other information prescribed by the regulations for the purposes of this section.

the first port or airport outside Australia;

if that is not reasonably practicable—the State Party’s National IHR Focal Point (within the meaning of the International Health Regulations).

disclose information (including personal information), on behalf of a responsible Commonwealth, State or Territory body, to the National Focal Point;

make a record of, or disclose or otherwise use, protected information in accordance with Division 6 or 7 of this Part.

the person is:

an officer or employee of the Commonwealth, a State, the Australian Capital Territory or the Northern Territory; or

an officer or employee of an agency or instrumentality of the Commonwealth, a State, the Australian Capital Territory or the Northern Territory; or

a person engaged by the Commonwealth, a State, the Australian Capital Territory or the Northern Territory, to perform public health work; or

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

the person makes the 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; and

for a permissible purpose.

do any of following for the purpose of giving effect to the International Health Regulations:

disclose protected information to the World Health Organization or a State Party;

make a record of or use protected information; and

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:

disclose protected information to a country that is affected or might be affected by the event;

make a record of or use protected information for the purpose of determining whether a country is affected by the event.

Use by other persons

to make a record of or use protected information for a permissible purpose that is specified in the authorisation; or

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.

to a court or tribunal, or in accordance with an order of a court or tribunal, for the purposes of proceedings; or

to a coronial inquiry, or in accordance with an order of a coroner, for the purposes of a coronial inquiry.

(a) a person (the first person) obtains protected information for a permissible purpose; and

the first person is:

an officer or employee of the Commonwealth, a State, the Australian Capital Territory or the Northern Territory; or

an officer or employee of an agency or instrumentality of the Commonwealth, a State, the Australian Capital Territory or the Northern Territory; or

a person engaged by the Commonwealth, a State, the Australian Capital Territory or the Northern Territory, to perform public health work; or

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

the first person also obtains the information, or substantially similar information, from another person; and

after obtaining the information as mentioned in paragraph (c), the first person makes a record of, or discloses or otherwise uses, the information; and

the record, disclosure or use is authorised under, or is not prohibited by:

another enactment of the Commonwealth; or

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.

Use by intelligence agencies

a person obtains protected information; and

the person discloses the information to an officer or employee of an intelligence agency prescribed by the regulations for the purposes of this section.

a person obtains protected information in accordance with a disclosure under subsection (2); and

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).

a person obtains protected information in accordance with a disclosure under subsection (3); and

the person makes a record of, or discloses or otherwise uses, the information:

for the purposes for which the information was disclosed under that subsection; or

for a prescribed purpose.

(a) a person (the first person) obtains protected information for a permissible purpose; and

the information relates to another person; and

the first person discloses the information to the other person.

any record of that information that is made by the person to whom the information relates;

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 in paragraph (a) or (b).

Consent to disclosure etc. of information

(a) 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.

a record may be made of the information; or

the information may be used or disclosed.

a record may be made of the information; or

the information may be used or disclosed.

an SES employee, or an acting SES employee, in the Department;

an SES employee, or an acting SES employee, in the Australian Centre for Disease Control.

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

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

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

monitoring of compliance with reporting and handling requirements through an inspection program; and

restrictions in relation to the handling of security-sensitive biological agents.

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

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

changing the reportable quantity of a biological agent in the list; or

correcting an inaccuracy.

the Minister has obtained advice from:

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

persons with scientific or technical knowledge of biological agents that may be of security concern to Australia; and

the Minister has sought advice from the States, the Australian Capital Territory and the Northern Territory.

the storage of security-sensitive biological agents;

the security status of individuals who are entitled to handle or dispose of security-sensitive biological agents;

the transport of security-sensitive biological agents;

the handling (including transport) of biological agents suspected, on the basis of testing in a laboratory, of being security-sensitive biological agents;

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.

is merely suspected by a specified entity, on the basis of testing in a laboratory, of being a security-sensitive biological agent; or

is a security-sensitive biological agent (regardless of any entity’s knowledge or ignorance of that fact); or

is known by a specified entity to be a security-sensitive biological agent; or

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.

persons with scientific or technical knowledge in relation to the security of biological agents; and

the States, the Australian Capital Territory and the Northern Territory.

decisions made by the Director-General under section 47, 49, 52 or 55A relating to the registration of an entity; and

any disposal of the entire holdings of a security-sensitive biological agent that is included on the National Register in relation to a registered entity and a facility; and

any loss or theft of a security-sensitive biological agent that is included on the National Register in relation to a registered entity and a facility.

(a) arrange for the carrying out (by the initial tester or another entity) of further testing (confirmatory testing) of the biological agent to determine whether the biological agent is a security-sensitive biological agent; or

destroy the biological agent in accordance with the SSBA Standards.

the initial tester’s suspicion is that the biological agent is a particular security-sensitive biological agent or included in a particular class of security-sensitive biological agents; and

the initial tester is a registered entity in relation to that particular security-sensitive biological agent or all security-sensitive biological agents in that particular class.

the entity is subject to a requirement under section 38B; and

the entity contravenes the requirement.

starting when the initial tester forms the suspicion; and

ending at the earlier of the following times:

the time the initial tester obtains the results of confirmatory testing;

the time destruction of the biological agent is completed.

starting when the entity is provided with the sample; and

ending when the entity obtains the results of the confirmatory testing.

states that the initial tester has transferred the biological agent or sample; and

identifies:

if the transfer was to another laboratory operated by the initial tester—that laboratory; or

if the transfer was to another entity—the entity and laboratory to which the transfer was made; and

is in a form approved by the Director-General; and

includes the information required by the approved form.

the entity is required by section 38F to give the Director-General of the CDC a report; and

the entity does not give the Director-General the report as required by that section.

states whether the biological agent is or is not a security-sensitive biological agent; and

is in a form approved by the Director-General; and

includes the information required by the approved form.

was done by the initial tester in the initial testing laboratory; and

indicates that the biological agent is not a security-sensitive biological agent.

the initial tester is a registered entity; and

confirmatory testing indicates that the biological agent is a security-sensitive biological agent not included in the National Register in relation to the initial tester and the facility where the initial tester has handled the biological agent.

the entity is required by section 38H to give the Director-General of the CDC a report; and

the entity does not give the Director-General the report as required by that section.

it is determined from confirmatory testing that the biological agent is a security-sensitive biological agent; and

within 2 business days, or such longer period as the Director-General of the CDC allows, after making or becoming aware of the determination, an entity that carried out the confirmatory testing or is the initial tester disposes of its entire holdings of the biological agent; and

the disposal is carried out in accordance with the SSBA Standards relating to the disposal of a biological agent that was previously suspected, on the basis of testing in a laboratory, of being a security-sensitive biological agent; and

before the entity carried out the disposal, the biological agent was not included on the National Register in relation to the entity.

Requirement to report disposal

states that the entity has disposed of its entire holdings of the biological agent in accordance with the SSBA Standards relating to the disposal of a biological agent that was previously suspected, on the basis of testing in a laboratory, of being a security-sensitive biological agent; and

is in a form approved by the Director-General; and

includes the information required by the approved form.

the entity is required by section 38K to give the Director-General of the CDC a report; and

the entity does not give the Director-General the report as required by that section.

is in a form approved by the Director-General; and

includes the information required by the approved form.

the initial tester’s suspicion is that the biological agent was a particular security-sensitive biological agent or included in a particular class of security-sensitive biological agents; and

the initial tester is a registered entity in relation to that particular security-sensitive biological agent or all security-sensitive biological agents in that particular class.

the entity is required by section 38M to give the Director-General of the CDC a report; and

the entity does not give the Director-General the report as required by that section.

the entity is given a direction under subsection 38P(2); and

the entity does not comply with the direction within the period allowed under that subsection.

the entity handles one or more security-sensitive biological agents at one or more facilities; and

the entity is not an exempt entity.

the entity handles the security-sensitive biological agents only for the purpose of transporting them from one place to another place; or

the entity is an entity, or a kind of entity, prescribed by the regulations to be an exempt entity.

an entity, or a kind of entity, in relation to all security-sensitive biological agents handled by the entity or kind of entity; or

an entity, or a kind of entity, in relation to a specified security-sensitive biological agent, or a specified class of security-sensitive biological agents, handled by the entity or kind of entity.

to carry out scientific or medical work with the security-sensitive biological agent:

to develop or produce a vaccine or treatment for it; or

to better understand a disease it causes;

in relation to a security-sensitive biological agent 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 security-sensitive biological agent; or

samples contaminated with a toxin;

but only if the analysis is carried out at a veterinary, diagnostic or pathology laboratory;

to carry out research that the Director-General of the CDC considers is responsible and legitimate;

to carry out forensic procedures in relation to the security-sensitive biological agent 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 security-sensitive biological agent—to carry out that testing or those other activities in relation to the security-sensitive biological agent;

any other purpose determined by the Minister, by legislative instrument, to be a legitimate purpose.

persons with scientific or technical knowledge in relation to security-sensitive biological agents; and

the States, the Australian Capital Territory and the Northern Territory.

within 2 business days after the entity starts to handle a security-sensitive biological agent; or

if a longer period is specified in a written notice given to the entity by the Director-General—within that longer period.

must be in a form approved by the Director-General of the CDC; and

must contain the following information:

the name of the entity;

the name and address of each facility where the entity handles a security-sensitive biological agent;

the name of each security-sensitive biological agent handled at each facility;

the purpose for which each security-sensitive biological agent is handled;

any other information required by the approved form; and

must state that the entity is complying with the SSBA Standards.

the entity is required to give a report to the Director-General of the CDC under subsection 42(1); and

the entity does not give the report to the Director-General as required by that subsection.

request the entity to provide such further information as the Director-General requires within the period specified in the notice, or within such longer period as the Director-General allows;

request the entity to allow an inspector to inspect a specified facility of the entity at a reasonable time.

the entity provided all the information required by paragraph 42(3)(b), and any further information requested under paragraph (2)(a) of this section, in relation to that security-sensitive biological agent and that facility; and

the entity stated in the report that it is complying with the SSBA Standards; and

the Director-General is satisfied that the purpose stated in the entity’s report for which the entity is handling that security-sensitive biological agent at that facility is a legitimate purpose.

the Director-General made a request under paragraph 44(2)(a) and the entity did not comply with the request within the period allowed under that paragraph; or

the entity did not state in the report that the entity is complying with the SSBA Standards.

the entity is given a direction under subsection 45(2); and

the entity does not comply with the direction within the period allowed under that subsection.

the requirements referred to in paragraphs 44(4)(a) and (b) are met in relation to a security-sensitive biological agent and a facility specified in the report; and

the Director-General is not satisfied that the purpose stated in the report for which the entity is handling that security-sensitive biological agent at that facility is a legitimate purpose.

decide to register the entity, on a temporary basis, in relation to the security-sensitive biological agent and the facility; and

notify the entity in writing of that fact.

the reason that the entity has been registered on a temporary basis in relation to the security-sensitive biological agent and the facility; and

(b) that handling a security-sensitive biological agent for a purpose other than a legitimate purpose may be an offence against the Crimes (Biological Weapons) Act 1976.

(a) the entity is convicted of an offence against the Crimes (Biological Weapons) Act 1976 in relation to its handling of the security-sensitive biological agent at the facility; or

the entity is found to have committed such an offence but no conviction is recorded;

the Director-General of the CDC must cancel the registration of the entity in relation to the security-sensitive biological agent and the facility.

if, within 12 months after the date on which the entity is registered under paragraph (2)(a), a decision is made not to institute a prosecution for an offence referred to in subsection (5)—as soon as practicable after the Director-General of the CDC becomes aware of that decision; or

in any other case—as soon as practicable after the end of the period of 12 months referred to in subsection (5).

(a) a prosecution for an offence against the Crimes (Biological Weapons) Act 1976, in relation to the entity’s handling of the security-sensitive biological agent at the facility, is instituted against the entity within 12 months after the date on which the entity is registered under paragraph (2)(a); and

the entity is found not to have committed the offence;

the Director-General of the CDC must vary the National Register to indicate that the registration made under that paragraph is no longer on a temporary basis.

the entity starts to handle at a facility a security-sensitive biological agent 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 security-sensitive biological agent 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 Director-General of the CDC under this Part);

if the entity is included on the National Register in relation to a facility and a security-sensitive biological agent 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 security-sensitive biological agent 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 security-sensitive biological agent 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 security-sensitive biological agent 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 security-sensitive biological agent that is included on the National Register in relation to the entity and a facility is lost or stolen;

a person accesses a security-sensitive biological agent that is included on the National Register in relation to the entity and a facility, and the access is unauthorised under the regulations;

any other event prescribed by the regulations for the purposes of this paragraph;

a period for which both the following conditions are met ends:

the duration of the period is prescribed by the regulations for the purposes of this subparagraph;

there is no occurrence in the period of a reportable event that is described in paragraph (h) and is prescribed by the regulations for the purposes of this subparagraph.

prescribe different periods in relation to different reportable events; and

prescribe a period in relation to a reportable event that ends before or after the event occurs.

must be in a form approved by the Director-General of the CDC; and

must include the information required by the approved form.

a reportable event occurs in relation to a registered entity and a facility in a State or Territory; and

the event is one described in paragraph 48(1)(f) or prescribed by the regulations for the purposes of this section.

is in a form approved by the Director-General of the CDC; and

includes the information required by the approved form.

prescribe different periods in relation to different reportable events; and

prescribe a period in relation to a reportable event that ends before or after the event occurs.

the entity is required by section 48A to give a report; and

the entity does not give the report as required by that section.

request the entity to provide such further information as the Director-General requires within the period specified in the notice, or within such longer period as the Director-General allows;

request the entity to allow an inspector to inspect a specified facility of the entity at a reasonable time.

the entity provided all the information required by paragraph 48(5)(b), and any further information requested under paragraph (2)(a) of this section, in relation to the reportable event; and

if the reportable event is the event referred to in paragraph 48(1)(a) or subparagraph 48(1)(d)(i)—the Director-General is satisfied that the purpose stated in the entity’s report for which the entity is handling the security-sensitive biological agent to which the reportable event relates is a legitimate purpose.

the Director-General made a request under paragraph 49(2)(a); and

the entity did not comply with the request within the period allowed under that paragraph.

the entity is given a direction under subsection 50(2); and

the entity does not comply with the direction within the period allowed under that subsection.

the reportable event to which the report relates is the event referred to in paragraph 48(1)(a) or subparagraph 48(1)(d)(i); and

the requirements referred to in paragraph 49(4)(a) are met; and

the Director-General is not satisfied that the purpose stated in the report for which the entity is handling the security-sensitive biological agent to which the reportable event relates is a legitimate purpose.

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 reason for the temporary variation; and

(b) that handling a security-sensitive biological agent for a purpose other than a legitimate purpose may be an offence against the Crimes (Biological Weapons) Act 1976.

(a) the entity is convicted of an offence against the Crimes (Biological Weapons) Act 1976 in relation to its handling of the relevant security-sensitive biological agent to which the reportable event relates; or

the entity is found to have committed such an offence but no conviction is recorded;

the Director-General of the CDC must cancel the variation of the National Register made under paragraph (2)(a).

if, within 12 months after the date on which the National Register is varied under paragraph (2)(a), a decision is made not to institute a prosecution for an offence referred to in subsection (5)—as soon as practicable after the Director-General of the CDC becomes aware of that decision; or

in any other case—as soon as practicable after the end of the period of 12 months referred to in subsection (5).

(a) a prosecution for an offence against the Crimes (Biological Weapons) Act 1976, in relation to the entity’s handling of the security-sensitive biological agent to which the reportable event relates, is instituted against the entity within 12 months after the date on which the National Register is varied under paragraph (2)(a); and

the entity is found not to have committed the offence;

the Director-General of the CDC must vary the National Register to indicate that the variation made under that paragraph is no longer on a temporary basis.

a reportable event has occurred in relation to a registered entity; and

the entity was required to give a report about the event under subsection 48(3) or section 48A; and

the entity has not given the report as required by that subsection or section.

the Director-General of the CDC gives an entity a written notice under subsection (2) in relation to a reportable event; and

the entity does not, within the period allowed under that subsection, give the Director-General a report that complies with paragraphs 48(5)(a) and (b) about the reportable event;

the Director-General may, if the Director-General considers it appropriate, give a written direction to the entity, requiring the entity, within the period specified in the direction or such longer period as the Director-General allows, to dispose of its entire holdings of the security-sensitive biological agent to which the reportable event relates.

the entity is given a direction under subsection 53(3); and

the entity does not comply with the direction within the period allowed under that subsection.

an individual is an officer or an employee of an entity, or is engaged as a consultant or a contractor by an entity; and

the entity is:

a body corporate; or

an agency or instrumentality of the Commonwealth, a State or a Territory; and

the individual’s duties include handling a security-sensitive biological agent at a facility of the entity;

the individual is not required to give a report under subsection 42(1) or 48(3) or section 48A in relation to that security-sensitive biological agent and that facility.

2 or more individuals handle one or more security-sensitive biological agents at the same facility; and

each individual is required to give a report under subsection 42(1) or 48(3) or section 48A in relation to those security-sensitive biological agents;

each individual satisfies that requirement if:

each individual gives a report under that subsection or section; or

all the individuals, acting jointly, give a joint report under that subsection or section.

(a) the entity needs to undertake unscheduled or unplanned repairs or maintenance of the facility because of, or to prevent, any of the following events:

damage to the facility;

damage, failure or breakdown of any equipment at the facility;

any other event prescribed by the regulations for the purposes of this subparagraph; and

the event significantly impacts, or is likely to significantly impact, on one or more of the following:

the secure handling of a security-sensitive biological agent that is included on the National Register in relation to the entity and the facility;

any other matter prescribed by the regulations for the purposes of this subparagraph.

must be in a form approved by the Director-General of the CDC; and

must contain the following information:

the name of the entity;

the name and address of the facility;

details of the emergency maintenance that the entity needs to undertake;

an estimate of the period during which the emergency maintenance will be undertaken;

if, because of the emergency maintenance, a security-sensitive biological agent that is included on the National Register in relation to the entity and the facility has been, or is to be, taken outside the perimeter (within the meaning of the SSBA Standards) of the facility by the entity—details of the location the security-sensitive biological agent has been, or is to be, taken to;

any other information required by the approved form; and

must be given to the Director-General:

within 2 business days after the entity becomes aware that it needs to undertake the emergency maintenance; or

if a longer period is specified in a written notice given to the entity by the Director-General—within that longer period.

that specified provisions of this Division do not apply to the entity and the facility during the emergency maintenance period for the report;

that this Division applies to the entity and the facility during the emergency maintenance period for the report as if specified provisions were omitted, modified or varied as specified in the instrument.

the importance of ensuring the secure handling of security-sensitive biological agents; and

any other matters the Director-General considers relevant.

(a) cancellation (total cancellation) of the entity’s registration relating to all security-sensitive biological agents for which the entity is registered; or

(b) cancellation (facility cancellation) of the entity’s registration so far as it relates to one or more specified facilities.

to cancel the registration in accordance with the application; or

to refuse the application.

may decide on total cancellation only if he or she is satisfied that the entity does not handle any security-sensitive biological agent that is included on the National Register in relation to the entity and a facility; and

may decide on facility cancellation only if he or she is satisfied that the entity does not handle at any of the facilities specified in the application any security-sensitive biological agent that is included on the National Register in relation to the entity and any of those facilities.

the physical security of the security-sensitive biological agent;

personnel security and information security in relation to the security-sensitive biological agent.

any or all of the security-sensitive biological agents handled by the entity; or

any or all of the facilities at which the entity handles those security-sensitive biological agents.

Director-General of the CDC may direct entity to dispose of security-sensitive biological agent

the Director-General of the CDC gives an entity a written notice under subsection (2) in relation to a security-sensitive biological agent it handles at a facility; and

the entity does not satisfy the Director-General, within the period allowed under that subsection, that the entity is complying with the SSBA Standards in relation to that security-sensitive biological agent;

the Director-General may give a written direction to the entity, requiring the entity, within the period specified in the direction or such longer period as the Director-General allows, to dispose of its entire holdings of that security-sensitive biological agent at that facility.

the Director-General of the CDC gives an entity a written notice under subsection (2) in relation to a security-sensitive biological agent it handles at a facility; and

a condition is imposed under subsection (2A) on the handling of the security-sensitive biological agent; and

the entity does not comply with the condition;

the Director-General may give a written direction to the entity, requiring the entity, within the period specified in the direction or such longer period as the Director-General allows, to dispose of its entire holdings of that security-sensitive biological agent at that facility.

the entity is given a direction under subsection 57(4) or (4A); and

the entity does not comply with the direction within the period allowed under that subsection.

that:

an individual who is handling a security-sensitive biological agent at a facility has not complied with this Part, regulations made for the purposes of this Part or the SSBA Standards; and

it would not be appropriate to require the individual or another entity to dispose of the security-sensitive biological agent; or

that the handling of a security-sensitive biological agent at a facility by a particular individual poses a security risk.

at any time in the future; or

until the individual satisfies the Director-General that the individual has satisfactorily completed specified training; or

until the individual satisfies the Director-General that the individual has obtained a specified qualification or certification; or

until the individual has complied with the requirements (if any) prescribed by the regulations.

the individual is given a direction under subsection 59(2); and

the individual does not comply with the direction.

an entity starts to handle a particular sample of a security-sensitive biological agent; and

the entity is not a registered entity; and

the entity is not an exempt entity;

the entity may give the Director-General of the CDC a report (a temporary handling report), for the sample, that complies with subsection (2).

must be in a form approved by the Director-General of the CDC; and

must contain the following information:

the name of the entity;

the name and address of each facility where the entity handles the sample;

the name of the security-sensitive biological agent;

the day on which the entity intends to dispose of the sample;

any other information required by the approved form; and

must state that the entity is complying with the temporary handling Standards in relation to the sample; and

must be given to the Director-General:

within 2 business days after the entity starts to handle the sample; or

if a longer period is specified in a written notice given to the entity by the Director-General—within that longer period.

must not be more 7 business days after the entity starts to handle the sample; or

if a later day is specified in a written notice given to the entity by the Director-General of the CDC—must not be later than that later day.

subsection (1) does not apply in relation to the handling of the sample by the entity after the end of the temporary handling period; and

section 42 applies to the entity and the security-sensitive biological agent as if the reference to 2 business days after the entity starts to handle the security-sensitive biological agent were a reference to 2 business days after the end of the temporary handling period.

must be in a form approved by the Director-General of the CDC; and

must state that the entity has disposed of the sample; and

must include the information required by the approved form; and

must be given to the Director-General:

within 2 business days after the disposal, or after the end of the temporary handling period for the sample, whichever happens first; or

if a longer period is specified in a written notice given to the entity by the Director-General—within that longer period.

the entity is required to give the Director-General of the CDC a temporary handling disposal report under subsection 60AD(2); and

the entity does not give the report to the Director-General as required by that subsection.

the entity gives the Director-General of the CDC a temporary handling report for a particular sample of a security-sensitive biological agent; and

any of the following events occurs in relation to the sample before the end of the temporary handling period for the sample:

the sample is lost or stolen;

a person accesses the sample, and the access is unauthorised under the regulations;

any other event prescribed by the regulations for the purposes of this subparagraph.

prescribe different periods in relation to different events; and

prescribe a period in relation to an event that ends before or after the event occurs.

must be in a form approved by the Director-General of the CDC; and

must include the information required by the approved form.

the entity is required to give a report to the Director-General of the CDC under subsection 60AF(2); and

the entity does not give the report to the Director-General as required by that subsection.

an event occurs in relation to an entity and a particular sample of a security-sensitive biological agent; and

the event occurs in a State or Territory; and

the event is:

one described in subparagraph 60AF(1)(b)(i); or

one described in subparagraph 60AF(1)(b)(ii) or (iii) and prescribed by the regulations for the purposes of this subparagraph.

is in a form approved by the Director-General of the CDC; and

includes the information required by the approved form.

prescribe different periods in relation to different events; and

prescribe a period in relation to an event that ends before or after the event occurs.

the entity is required by section 60AH to give a report; and

the entity does not give the report as required by that section.

the security risks posed by the handling of the security-sensitive biological agent by the entity; and

any other matters the Director-General considers relevant.

a condition is imposed under subsection 60AM(2) on the handling of a particular sample of a security-sensitive biological agent by an entity; and

the Director-General of the CDC believes, on reasonable grounds, that the entity is not complying with the condition in relation to the sample.

the Director-General of the CDC gives an entity a written notice under subsection (2) in relation to a condition; and

the entity does not satisfy the Director-General, within the period allowed under that subsection, that the entity is complying with the condition;

the Director-General may give the entity a written direction requiring the entity, within the period specified in the direction or such longer period as the Director-General allows, to dispose of the sample.

the entity is given a direction under subsection 60AO(3); and

the entity does not comply with the direction within the period allowed under that subsection.

all or specified provisions of Division 4A;

section 38D, so far as it relates to specified provisions of the SSBA Standards.

all or specified provisions of Division 5;

section 56, so far as it relates to specified provisions of the SSBA Standards.

all or specified provisions of Division 5AA;

section 60AK, so far as it relates to specified provisions of the temporary handling Standards.

the Minister is satisfied, after considering advice from a person covered by subsection (3), that there is a threat involving the agent to one or more of the following:

the health or safety of people;

the economy;

the environment; and

the Minister is satisfied, after considering advice from the Director-General of the CDC, that the making of the legislative instrument would help to reduce the threat and maintain adequate controls for the security of all security-sensitive biological agents.

the Commonwealth Chief Medical Officer; and

the Commonwealth Chief Veterinary Officer; and

another person whom the Minister believes has scientific or technical knowledge in relation to security-sensitive biological agents.

When legislative instrument commences

on the day on which the instrument is made; or

if the instrument specifies a later day as the day on which it commences, on that day.

the Minister has considered advice about the variation from the persons whose advice was considered for the purposes of making the principal instrument; and

the Minister is satisfied that the principal instrument as varied would help to reduce the threat to which the principal instrument relates and maintain adequate controls for the security of all security-sensitive biological agents.

Preconditions for revocation

the Minister is satisfied that the threat, or one of the threats, to which the principal instrument relates:

no longer exists; or

is no longer such as to require the principal instrument to be in force to address that threat; or

the Minister is no longer satisfied that the principal instrument adequately addresses the threat, or one of the threats, to which it relates.

When variation or revocation commences

on the day on which the instrument is made; or

if the instrument specifies a later day as the day on which it commences, on that day.

an entity is given a direction under subsection 38P(2), 45(2), 50(2), 53(3), 57(4), 57(4A) or 60AO(3); and

the entity does not comply with the direction within the period allowed under that subsection.

a person has refused or failed, is refusing or failing, or is about to refuse or fail, to do a thing; and

the refusal or failure is, or would be, an offence against this Part;

the Court may, on the application of the Director-General of the CDC, grant an injunction requiring the person to do the thing.

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.

must satisfy the requirements prescribed by the regulations; and

must contain a recent photograph of the inspector.

enter any premises; and

exercise the monitoring powers set out in section 66;

for any of the following purposes:

to find out whether this Part or regulations made for the purposes of this Part, or the SSBA Standards, have been complied with;

to verify that the information given to the Director-General of the CDC by an entity under section 38F, 38H, 38K, 38M, 42, 44, 48, 49, 55AA, 60AA, 60AD or 60AF is accurate and up-to-date.

the occupier of the premises has consented to the entry; or

the entry is made under a monitoring warrant.

to search the premises and any thing on the premises;

to inspect, examine, take measurements of, conduct tests on, or take samples of, any biological agent that is, or is suspected of being, a security-sensitive biological agent 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 book, record or document requested by the inspector;

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; and

(ii) 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;

to operate electronic equipment, and do other things, at the premises as mentioned in section 67.

the equipment; or

a disk, tape or other storage device that:

is at the premises; and

can be used with equipment or is associated with it;

contains information that is relevant to determining whether there has been compliance with this Part or regulations made for the purposes of this Part, or the SSBA Standards.

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 use of which for the purpose has been agreed to in writing by the occupier of the premises;

operate the equipment or other facilities to copy the information to the storage device, and remove the storage device from 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;

to verify that the information given to the Director-General of the CDC by an entity under section 42, 44, 48, 49, 55AA, 60AA, 60AD or 60AF is accurate and up-to-date.

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 section 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 of the day or night; 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.

enter the premises; and

exercise the offence-related powers set out in section 70A.

the occupier of the premises has consented to the entry and the inspector has shown his or her identity card if required by the occupier; or

the entry is made under an offence-related warrant.

if entry to the premises is with the occupier’s consent—the power to search the premises and any thing on the premises for the evidential material the inspector has reasonable grounds for suspecting may be on the premises;

if entry to the premises is under an offence-related warrant:

the power to search the premises and any thing on the premises for the kind of evidential material specified in the warrant; and

the power to seize evidential material of that kind if the inspector finds it on the premises;

the power to inspect, examine, take measurements of, conduct tests on or take samples of evidential material referred to in paragraph (a) or (b);

the power to make any still or moving image or any recording of the premises or evidential material referred to in paragraph (a) or (b);

the power to take onto the premises such equipment and materials as the inspector requires for the purpose of exercising powers in relation to the premises;

the powers set out in subsections (2), (3) and (6).

Powers relating to electronic equipment

the equipment; or

a disk, tape or other storage device that:

is on the premises; and

can be used with the equipment or is associated with it;

contains evidential material referred to in paragraph (1)(a) or (b).

if entry to the premises is under an offence-related warrant—the power to seize the equipment and the disk, tape or other storage device referred to in that subsection;

the power to operate electronic equipment on the premises to put the evidential material in documentary form and remove the documents so produced from the premises;

the power to operate electronic equipment on the premises to transfer the evidential material to a disk, tape or other storage device that:

is brought to the premises for the exercise of the power; or

is on the premises and the use of which for that purpose has been agreed in writing by the occupier of the premises;

and remove the disk, tape or other storage device from the premises.

it is not practicable to put the evidential material in documentary form as mentioned in paragraph (3)(b) or to transfer the evidential material as mentioned in paragraph (3)(c); or

possession of the equipment or the disk, tape or other storage device by the occupier could constitute an offence against a law of the Commonwealth.

Seizing other evidential material

entry to the premises is under an offence-related warrant; and

the inspector, in the course of searching for the kind of evidential material specified in the warrant, finds a thing that the inspector believes on reasonable grounds to be other evidential material; and

the inspector believes on reasonable grounds that it is necessary to seize the thing in order to prevent its concealment, loss or destruction;

then the offence-related powers include seizing the thing.

enter the premises; and

exercise offence-related powers in relation to the premises, but only in accordance with a direction given to the person by the inspector.

answer any questions relating to the reasons for the inspector entering the premises that are put by the inspector; and

produce any document relating to the reasons for the inspector entering the premises that is requested by the inspector.

Entry under an offence-related warrant

answer any questions relating to the reasons for the inspector entering the premises that are put by the inspector; and

produce any document relating to the reasons for the inspector entering the premises that is requested by the inspector.

Offence

the person is subject to a requirement under subsection (2); and

the person fails to comply with the requirement.

an inspector executing the warrant; and

any person assisting the inspector;

with all reasonable facilities and assistance for the effective exercise of their powers.

the person is subject to subsection (1); and

the person fails to comply with that subsection.

a document, film, computer file or other thing that can be readily copied; or

a storage device, the information in which can be readily copied;

the inspector must, if requested to do so by the occupier of the premises, or another person who apparently represents the occupier and who is present when the warrant is executed, give a copy of the thing or the information to the occupier or other person as soon as practicable after the seizure.

the reason for its seizure no longer exists or it is decided that it is not to be used in evidence; or

the period of 60 days after its seizure ends;

whichever happens first, unless the thing is forfeited or forfeitable to the Commonwealth or is the subject of a dispute as to ownership.

proceedings in respect of which the thing may afford evidence were instituted before the end of the 60 days and have not been completed (including an appeal to a court in relation to those proceedings); or

the thing may continue to be retained because of an order under section 70K; or

the Commonwealth, the Director-General or an inspector is otherwise authorised (by a law, or an order of a court, of the Commonwealth or of a State or Territory) to retain, destroy, dispose of or otherwise deal with the thing; or

to return the thing could cause an imminent risk of death, serious illness, serious injury or serious damage to the environment.

before the end of 60 days after the seizure; or

before the end of a period previously specified in an order of a magistrate under this section;

proceedings in respect of which the thing may afford evidence have not commenced.

(a) for the purposes of an investigation as to whether an offence against this Act, or an offence against the Crimes Act 1914 or the Criminal Code that relates to this Act, has been committed; or

to enable evidence of such an offence to be secured for the purposes of a prosecution;

the magistrate may order that the thing may continue to be retained for a period specified in the order (which must not exceed 3 years).

take reasonable steps to discover who has an interest in the retention of the thing; and

if it is practicable to do so, notify each person whom the inspector believes to have such an interest of the proposed application.

a thing is seized under this Subdivision; and

apart from this section, the Director-General of the CDC would be required to take reasonable steps to return the thing to a person; and

either:

the Director-General cannot, despite making reasonable efforts, locate the person; or

the person has refused to take possession of the thing;

the Director-General may dispose of the thing in such manner as he or she thinks appropriate.

describe the premises to which the warrant relates; and

state that the warrant is issued under this Subdivision; and

specify the kind of evidential material that is to be searched for under the warrant; and

name one or more inspectors; and

authorise the inspector or inspectors so named:

to enter the premises; and

to exercise the powers set out in sections 70, 70A, 70B, 70C and 70D in relation to the premises; and

state whether the entry is authorised to be made at any time of the day or during specified hours of the day; and

specify the day (not more than one week after the issue of the warrant) on which the warrant ceases to be in force.

after considering the terms of the information; and

after receiving such further information (if any) as the magistrate requires concerning the grounds on which the issue of the warrant is being sought;

that there are reasonable grounds for issuing the warrant, the magistrate may complete and sign the same warrant that the magistrate would issue under section 70M if the application had been made under that section.

Notification

the terms of the warrant; and

the day on which and the time at which the warrant was signed.

Form of warrant

the form of warrant completed by the inspector; and

the information referred to in subsection (3), which must have been duly sworn or affirmed.

Attachment

it is material, in any proceedings, for a court to be satisfied that an exercise of a power was authorised by this section; and

the warrant signed by the magistrate authorising the exercise of the power is not produced in evidence;

the court must assume, unless the contrary is proved, that the exercise of the power was not authorised by such a warrant.

any of the following may be accessible by operating a thing at particular premises:

information relevant to determining whether there has been compliance with this Part or regulations made for the purposes of this Part, or the SSBA Standards;

evidential material; and

expert assistance is required to operate the thing; and

if he or she does not take action under this subsection, the information or material may be destroyed, altered or otherwise interfered with;

he or she may do whatever is necessary to secure the thing, whether by locking it up, placing a guard or otherwise.

for a period not exceeding 24 hours; or

until the thing has been operated by the expert;

whichever happens first.

an inspector has reasonable grounds for suspecting that there may be on any premises:

a particular thing in respect of which this Part or regulations made for the purposes of this Part, or the SSBA Standards, have not been complied with; or

evidential material; and

the inspector considers that assistance from a person with scientific or technical knowledge or expertise is necessary to ensure the safety of the inspector and any other person while the inspector is exercising powers under this Division.

an inspector has reasonable grounds for suspecting that there may be on any premises a particular thing in respect of which this Part or regulations made for the purposes of this Part, or the SSBA Standards, have not been complied with; and

the inspector considers that it is necessary to exercise powers under this section in order to avoid an imminent risk of death, serious illness, serious injury, or to protect the environment.

enter the premises;

search the premises for the thing;

secure the thing, if the inspector finds it on the premises, until a warrant is obtained to seize the thing;

if the inspector has reasonable grounds for suspecting that a person has not complied with this Part or regulations made for the purposes of this Part, or the SSBA Standards, in respect of the thing—require the person to take such steps as the inspector considers necessary for the person to comply with this Part or those regulations, or the SSBA Standards;

take such steps, or arrange for such steps to be taken, in relation to the thing as the inspector considers appropriate.

announce that he or she is authorised to enter the premises; and

show his or her identity card to the occupier of the premises, or to another person who apparently represents the occupier, if the occupier or other person is present at the premises; and

give any person at the premises an opportunity to allow entry to the premises.

to ensure the safety of a person; or

to prevent serious damage to the environment; or

to ensure that the effective execution of the warrant is not frustrated.

an inspector does not comply with subsection (1) because of subsection (2); and

the occupier of the premises, or another person who apparently represents the occupier, is present at the premises;

the inspector must, as soon as practicable after entering the premises, show his or her identity card to the occupier or other person.

Subdivision G—Other matters

as a result of electronic equipment being operated as mentioned in section 67 (about monitoring powers) or section 70A (about offence-related powers):

damage is caused to the equipment; or

the data recorded on the equipment is damaged; or

programs associated with the use of the equipment, or with the use of the data, are damaged or corrupted; and

the damage or corruption occurs because:

insufficient care was exercised in selecting the person who was to operate the equipment; or

insufficient care was exercised by the person operating the equipment.

the terms of the decision; and

the reasons for the decision; and

a statement setting out particulars of the entity’s review rights.

make a decision affirming, varying or revoking the reviewable decision; and

if the Director-General revokes the decision, make such other decision as the Director-General thinks appropriate.

a reviewable decision made by the Director-General of the CDC personally; or

a decision made by the Director-General under section 82 (which provides for internal review).

such intelligence agencies as are prescribed by the regulations for the purposes of this paragraph; or

such law enforcement agencies as are prescribed by the regulations for the purposes of this paragraph; or

any Commonwealth, State or Territory agencies with responsibility for responding to emergencies;

in order to enable those agencies to assess the security risks posed in relation to security-sensitive biological agents, and biological agents suspected of being security-sensitive biological agents, and take action in relation to those risks.

to make a record of or otherwise 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.

this Part; or

(b) the Crimes (Biological Weapons) Act 1976; or

(c) Criminal Code; orPart 5.3 or 5.5 of the

any other prescribed law of the Commonwealth or of a State or Territory.

the person obtains information; and

the information is protected information; and

the person makes a record of, or discloses or otherwise uses, the information.

would contravene a provision of this Division; or

would not be permitted by a provision of this Division.

an SES employee, or an acting SES employee, in the Department;

an SES employee, or an acting SES employee, in the Australian Centre for Disease Control.