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National Health Security Regulations 2008

Authoritative Version
  • - F2010C00436
  • In force - Superseded Version
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SLI 2008 No. 55 Regulations as amended, taking into account amendments up to SLI 2010 No. 128
These Regulations prescribe the Australian Security Intelligence Organisation and the Australian Federal Police as intelligence agencies authorised to use information obtained for broader intelligence purposes under the National Health Security Act 2007.
Administered by: Health
Registered 21 Jun 2010
Start Date 19 Jun 2010
End Date 30 Mar 2013

National Health Security Regulations 2008

Select Legislative Instrument 2008 No. 55 as amended

made under the

This compilation was prepared on 19 June 2010
taking into account amendments up to SLI 2010 No. 128

Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra


Contents

Part 1                    Preliminary                                                                 

                    1.01     Name of Regulations [see Note 1]                                     4

                    1.02     Commencement [see Note 1]                                           4

                    1.03     Definitions                                                                       4

Part 2                    Public health surveillance                                      

                    2.01     Prescribed intelligence agencies                                       5

Part 3                    Regulation of security‑sensitive biological agents       

Division 3.1             National Register                                                           

                    3.01     Content of National Register                                             6

Division 3.2             Exempt entities                                                              

                    3.02     Application of Division 3.2                                                 7

                    3.03     Law enforcement agencies                                               7

                    3.04     Depot or warehouse licence holders                                  7

                    3.05     Persons or animals affected by security‑sensitive biological agents     8

                    3.06     Treatment of persons or animals affected by security‑sensitive biological agents           8

                    3.07     Handling of human bodies                                                 8

                    3.08     Handling of mice to test for botulinum toxin                        9

Division 3.4             Reportable events etc                                                    

Subdivision 3.4.1       Unauthorised access                                                                           

                    3.15     Unauthorised access                                                       9

Subdivision 3.4.2       Reportable events                                                                                 

                    3.16     Application of Subdivision 3.4.2                                       10

                    3.17     Transfer — SSBA successfully received                           10

                    3.18     Unsuccessful transfer of SSBA                                       11

                    3.19     Transfer — SSBA not received                                        11

                    3.20     Unauthorised handling etc                                               12

                    3.21     Unauthorised access to sensitive information                    13

                    3.22     Attempt to steal SSBA                                                   13

                    3.23     Attempt to access or handle SSBA                                 14

                    3.24     Attempt to access sensitive information                           14

                    3.25     Accidental release of SSBA                                            15

                    3.26     Persons affected by a security‑sensitive biological agent   15

                    3.27     Change in particulars                                                      15

Division 3.5             Requirement to report changes                                     

Subdivision 3.5.1       Preliminary                                                                                              

                    3.40     Application of Division 3.5                                               16

Subdivision 3.5.2       Reporting events as they occur                                                         

                    3.41     Handling SSBA                                                              16

                    3.42     Transfer or disposal of SSBA                                          17

                    3.43     Unsuccessful transfer                                                     17

                    3.44     Loss, theft and unauthorised access etc                          18

                    3.45     Particulars — responsible officer and deputy responsible officer           19

                  3.45A     Events that must be reported to police                             19

                  3.45B     Period for reporting reportable events to police                  20

Subdivision 3.5.3       Reporting events for a period                                                             

                    3.46     Definitions                                                                     20

                    3.47     Reportable events to which this Subdivision applies           20

                    3.48     Tier 1 agents — reporting periods                                    21

                    3.49     Tier 2 agents — reporting period                                      21

                    3.50     When entity must report                                                 21

                    3.51     Periodic nil reporting                                                       22

Division 3.7             Miscellaneous                                                                

                    3.70     Identity cards                                                                 23

                    3.71     Confidentiality of information                                            23

Notes                                                                                                          24

 


Part 1                 Preliminary

  

1.01        Name of Regulations [see Note 1]

                These Regulations are the National Health Security Regulations 2008.

1.02        Commencement [see Note 1]

                These Regulations commence on the day after they are registered.

1.03        Definitions

         (1)   In these Regulations:

Act means the National Health Security Act 2007.

affected has the meaning given by subregulation (2).

Australian Quarantine and Inspection Service means the operating group within the Department that is responsible for administration of the Quarantine Act 1908.

sensitive information, for a security‑sensitive biological agent an entity handles at a facility, means any of the following:

                (a)    the entity’s storage records for the security‑sensitive biological agent handled at the facility;

               (b)    an entity’s risk assessment plan for the security‑sensitive biological agent handled at the facility;

                (c)    an entity’s risk management plan for the security‑sensitive biological agent handled at the facility;

               (d)    any other information that the entity identifies as being sensitive information under Part 5 of the SSBA Standards because it could compromise the security of the security‑sensitive biological agent handled at the facility.

         (2)   The body of a person or animal is affected by a security‑sensitive biological agent if the security‑sensitive biological agent has been introduced into the body.

Part 2                 Public health surveillance

2.01        Prescribed intelligence agencies

                For paragraph 23 (2) (b) of the Act, each of the following intelligence agencies is prescribed:

                (a)    Australian Security Intelligence Organisation;

               (b)    Australian Federal Police.

Part 3                 Regulation of security‑sensitive biological agents

Division 3.1           National Register

3.01        Content of National Register

                For paragraph 37 (f) of the Act, the following particulars are prescribed:

                (a)    if an entity is located in a place other than a facility where the entity handles security‑sensitive biological agents:

                          (i)    the address of the place at which the entity is located; and

                         (ii)    the entity’s postal address;

               (b)    the entity’s contact telephone number, fax number and email address;

                (c)    if the entity has an ABN, ACN or ARBN — those details;

               (d)    for each facility of the entity:

                          (i)    the geographic coordinates of the facility, expressed in terms of the Geocentric Datum of Australia 1994; and

                         (ii)    the fax number;

                (e)    for each facility of the entity — the name, contact telephone number, after hours contact telephone number, and email address at the facility, of:

                          (i)    the person who is the responsible officer (within the meaning of the SSBA Standards) for the facility; and

                         (ii)    the person who is the deputy responsible officer (within the meaning of the SSBA Standards) for the facility;

                (f)    if the Secretary decides to vary the National Register temporarily to take account of a reportable event mentioned in paragraph 48 (1) (a) or subparagraph 48 (1) (d) (i) of the Act — a statement to that effect.

                (g)    if the Secretary decides to vary the National Register to take account of a reportable event for the entity under subsection 49 (1) of the Act — details of the reportable event;

Note   The Geocentric Datum of Australia 1994 was published in Gazette No. GN35 of 6 September 1995.

Division 3.2           Exempt entities

3.02        Application of Division 3.2

                For paragraph 40 (1) (b) of the Act, this Division prescribes entities to be exempt entities.

3.03        Law enforcement agencies

         (1)   A law enforcement agency that handles a security‑sensitive biological agent is an exempt entity if it handles a security‑sensitive biological agent in the course of carrying out a function under a law of the Commonwealth, or of a State or Territory.

         (2)   However, the law enforcement agency is not an exempt entity if it handles the security‑sensitive biological agent for the purpose of using it as a control sample for testing or carrying out diagnostic analysis.

         (3)   In this regulation:

law enforcement agency means:

                (a)    the Australian Federal Police; or

               (b)    a police force of a State or Territory; or

                (c)    the Australian Customs Service; or

               (d)    the Australian Quarantine and Inspection Service.

3.04        Depot or warehouse licence holders

                An entity that handles a security‑sensitive biological agent is an exempt entity if the entity:

                (a)    holds either a depot licence under section 77G of the Customs Act 1901 or a warehouse licence under section 79 of that Act; and

               (b)    handles the security‑sensitive biological agent in accordance with the licence.

3.05        Persons or animals affected by security‑sensitive biological agents

         (1)   A person who is affected by a security‑sensitive biological agent is an exempt entity while affected by the security‑sensitive biological agent.

         (2)   An entity is an exempt entity if:

                (a)    the entity destroys an animal that is affected by a security‑sensitive biological agent; and

               (b)    the entity’s destruction of the animal is carried out because the animal is affected by a security‑sensitive biological agent.

3.06        Treatment of persons or animals affected by security‑sensitive biological agents

                An entity is an exempt entity if:

                (a)    the entity provides treatment to a person who, or an animal that, has been affected by a security‑sensitive biological agent; and

               (b)    the entity handles the security‑sensitive biological agent:

                          (i)    while the security‑sensitive biological agent is in the body of the person or the animal; or

                         (ii)    while taking a sample from the person or the animal for the purposes of the treatment.

3.07        Handling of human bodies

                An entity is an exempt entity for the purpose of examining, burying or cremating human bodies if:

                (a)    the functions of the entity include:

                          (i)    examination, identification, storage or transport of the bodies of deceased persons; or

                         (ii)    preparation of the bodies of deceased persons for burial or cremation; and

               (b)    the entity performs any of the functions mentioned in paragraph (a) on the body of a person who, before his or her death, was affected by a security‑sensitive biological agent.

3.08        Handling of mice to test for botulinum toxin

         (1)   An entity is an exempt entity for the purpose of handling mice to test for the presence of botulinum toxin if:

                (a)    the entity has functions that include the use of mice to test for the presence of botulinum toxin; and

               (b)    the entity conducts a test on mice for the presence of botulinum toxin.

         (2)   However, an entity is not an exempt entity if it handles botulinum toxin for the purpose of using it as a control sample for testing or carrying out diagnostic analysis.

Division 3.4           Reportable events etc

Subdivision 3.4.1        Unauthorised access

3.15        Unauthorised access

         (1)   For paragraph 48 (1) (g) of the Act, access to a security‑sensitive biological agent is unauthorised if:

                (a)    a person at a facility of a registered entity enters a place where a security‑sensitive biological agent is handled; and

               (b)    subregulation (2) applies to the person.

         (2)   This subregulation applies if:

                (a)    the person is:

                          (i)    not authorised by the entity, in accordance with Part 3 of the SSBA Standards, to enter the place; or

                         (ii)    not approved by the entity, in accordance with Part 3 of the SSBA Standards, to enter the place; or

               (b)    if the person holds an authorisation, issued by the entity under Part 3 of the SSBA Standards, to enter the place — the person enters the place not in accordance with the authorisation; or

                (c)    if the person holds an approval, issued by the entity under Part 3 of the SSBA Standards, to enter the place — the person enters the place not in accordance with the approval.

Subdivision 3.4.2        Reportable events

3.16        Application of Subdivision 3.4.2

                For paragraph 48 (1) (h) of the Act, this Subdivision prescribes events to be reportable events.

3.17        Transfer — SSBA successfully received

         (1)   Subregulation (2) applies if:

                (a)    an entity is included on the National Register in relation to a facility and a security‑sensitive biological agent; and

               (b)    the entity transfers the security‑sensitive biological agent to:

                          (i)    another facility of the entity; or

                         (ii)    another registered entity (the receiving entity); and

                (c)    the receiving entity, or the entity in relation to its other facility, verifies, in accordance with Part 6 of the SSBA Standards, that the security‑sensitive biological agent has been received by the receiving entity or at the other facility.

         (2)   The event mentioned in paragraph (1) (c) is a reportable event for:

                (a)    if the security‑sensitive biological agent is transferred to another entity — the receiving entity; or

               (b)    if the security‑sensitive biological agent is transferred to another facility of the entity — the entity in relation to the other facility.

Note   The event mentioned in paragraph (1) (b) is a reportable event, for the entity that transfers a security‑sensitive biological agent, under paragraph 48 (1) (e) of the Act.

3.18        Unsuccessful transfer of SSBA

         (1)   Subregulation (2) applies if:

                (a)    an entity is included on the National Register in relation to a facility and a security‑sensitive biological agent; and

               (b)    the entity enters into an arrangement:

                          (i)    for another facility of the entity; or

                         (ii)    with another entity (whether or not registered) (the receiving entity); and

                (c)    the arrangement concerns the transfer of the security‑sensitive biological agent to the receiving entity or the other facility; and

               (d)    the receiving entity, or the entity in relation to its other facility, is unable to verify, in accordance with Part 6 of the SSBA Standards, that the transport to it of the security‑sensitive biological agent is successful.

         (2)   The event mentioned in paragraph (1) (d) is a reportable event for:

                (a)    if the security‑sensitive biological agent is being transferred to another entity and that entity is registered — the receiving entity; or

               (b)    if the security‑sensitive biological agent is being transferred to another of the entity’s facilities:

                          (i)    the entity in relation to its other facility; and

                         (ii)    the entity in relation to the facility from which the security‑sensitive biological agent is transferred.

Note   For the obligations of an unregistered entity, see subsection 42 (1) of the Act.

3.19        Transfer — SSBA not received

         (1)   Subregulation (2) applies if:

                (a)    an entity is included on the National Register in relation to a facility and a security‑sensitive biological agent; and

               (b)    the entity enters into an arrangement:

                          (i)    for another facility of the entity; or

                         (ii)    with another registered entity (the receiving entity); and

                (c)    the arrangement concerns the transfer of the security‑sensitive biological agent to the receiving entity or the other facility; and

               (d)    the security‑sensitive biological agent is not received by the receiving entity or at the other facility at the time notified, in accordance with Part 6 of the SSBA Standards, by the entity transferring the security‑sensitive biological agent.

         (2)   The event mentioned in paragraph (1) (d) is a reportable event for:

                (a)    if the security‑sensitive biological agent is being transferred to another entity — the receiving entity; or

               (b)    if the security‑sensitive biological agent is being transferred to another of the entity’s facilities — the entity in relation to the other facility of the entity.

Note   The event mentioned in paragraph (1) (d) is a reportable event, for the entity that transfers a security‑sensitive biological agent, under paragraph 48 (1) (f) of the Act.

3.20        Unauthorised handling etc

         (1)   It is a reportable event for a registered entity if:

                (a)    a person at a facility of the entity handles a security‑sensitive biological agent that is included on the National Register in relation to the entity and that facility; and

               (b)    subregulation (2) applies to the person.

         (2)   This subregulation applies if:

                (a)    the person is:

                          (i)    not authorised by the entity, in accordance with Part 3 of the SSBA Standards, to handle the security‑sensitive biological agent at the facility; or

                         (ii)    not approved by the entity, in accordance with Part 3 of the SSBA Standards, to handle the security‑sensitive biological agent at the facility; or

               (b)    if the person holds an authorisation, issued by the entity under Part 3 of the SSBA Standards, to handle the security‑sensitive biological agent at the facility — the person handles the security‑sensitive biological agent not in accordance with the authorisation; or

                (c)    if the person holds an approval, issued by the entity under Part 3 of the SSBA Standards, to handle the security‑sensitive biological agent at the facility — the person handles the security‑sensitive biological agent not in accordance with the approval.

3.21        Unauthorised access to sensitive information

                It is a reportable event for a registered entity if:

                (a)    a person at a facility of the entity accesses information about a security‑sensitive biological agent handled by the entity at the facility; and

               (b)    the information is sensitive information; and

                (c)    the person:

                          (i)    is not authorised by the entity, in accordance with Part 3 of the SSBA Standards, to access the information; or

                         (ii)    if the person holds an authorisation, issued by the entity under Part 3 of the SSBA Standards, to access the information — accesses the information not in accordance with the authorisation.

Note   Sensitive information is defined in regulation 1.03.

3.22        Attempt to steal SSBA

                It is a reportable event for a registered entity if there has been an attempted theft, at a facility of the entity, of a security‑sensitive biological agent that the entity handles at the facility.

3.23        Attempt to access or handle SSBA

         (1)   It is a reportable event for a registered entity if:

                (a)    a person attempts to access a security‑sensitive biological agent that the entity handles at a facility; and

               (b)    access to the security‑sensitive biological agent by the person at the facility is unauthorised.

Note   See regulation 3.15 for when access to a security‑sensitive biological agent is unauthorised.

         (2)   It is a reportable event for a registered entity if:

                (a)    a person attempts to handle a security‑sensitive biological agent that the entity handles at a facility; and

               (b)    subregulation (3) applies to the person.

         (3)   This subregulation applies if:

                (a)    the person is:

                          (i)    not authorised by the entity in accordance with Part 3 of the SSBA Standards; or

                         (ii)    not approved by the entity in accordance with Part 3 of the SSBA Standards; or

               (b)    if handling by the person is authorised by the entity under Part 3 of the SSBA Standards — the person’s attempt is not in accordance with the authorisation; or

                (c)    if handling by the person is approved by the entity under Part 3 of the SSBA Standards — the person’s attempt is not in accordance with the approval.

3.24        Attempt to access sensitive information

                It is a reportable event for a registered entity if:

                (a)    a person attempts to access sensitive information about a security‑sensitive biological agent handled by the entity at a facility; and

               (b)    access to the information by the person at the facility is:

                          (i)    not authorised by the entity in accordance with Part 3 of the SSBA Standards; or

                         (ii)    if the person holds an authorisation, issued by the entity under Part 3 of the SSBA Standards, to access the information — attempted by the person not in accordance with the authorisation.

3.25        Accidental release of SSBA

                It is a reportable event for a registered entity if:

                (a)    a security‑sensitive biological agent is included on the National Register in relation to the entity and a facility; and

               (b)    the security‑sensitive biological agent is accidentally released during its handling by a person at the facility.

3.26        Persons affected by a security‑sensitive biological agent

                It is a reportable event for a registered entity if:

                (a)    a security‑sensitive biological agent is included on the National Register in relation to the entity and a facility; and

               (b)    a person who has been to the facility is affected by a security‑sensitive biological agent as a result of the entity’s handling of the security‑sensitive biological agent at the facility.

3.27        Change in particulars

         (1)   It is a reportable event for a registered entity if there are any of the following changes:

                (a)    a change to the entity’s name;

               (b)    if the entity is located in a place other than a facility where the entity handles a security‑sensitive biological agent:

                          (i)    a change to the location of the entity; or

                         (ii)    a change to the entity’s postal address;

                (c)    a change to the entity’s contact telephone number, fax number or email address;

               (d)    a change to the entity’s ABN, ACN or ARBN.

         (2)   It is a reportable event for a registered entity if there are any of the following changes for a facility of the entity:

                (a)    a change to the name, location or fax number of the facility;

               (b)    a change to the contact telephone number, after hours contact telephone number, or email address at the facility, of the responsible officer or the deputy responsible officer;

                (c)    a person who is the responsible officer for the facility ceases to be the responsible officer;

               (d)    a person who is the deputy responsible officer for the facility ceases to be the deputy responsible officer;

                (e)    the appointment of a person as the responsible officer or the deputy responsible officer for the facility.

Division 3.5           Requirement to report changes

Subdivision 3.5.1        Preliminary

3.40        Application of Division 3.5

                For subsection 48 (3) of the Act, this Division prescribes the period within which a report about a reportable event must be given by an entity to the Secretary.

Subdivision 3.5.2        Reporting events as they occur

3.41        Handling SSBA

         (1)   An entity must report the following reportable events within 2 business days after the entity starts to handle the security‑sensitive biological agent:

                (a)    a reportable event mentioned in paragraph 48 (1) (a) of the Act (entity starts to handle a security‑sensitive biological agent);

               (b)    a reportable event mentioned in subparagraph 48 (1) (d) (i) of the Act (entity starts to handle a security‑sensitive biological agent for a purpose not specified in the National Register).

         (2)   An entity must report a reportable event mentioned in subparagraph 48 (1) (d) (ii) of the Act (entity stops handling a security‑sensitive biological agent for a purpose specified in the National Register) within 2 business days after the entity stops handling the security‑sensitive biological agent.

3.42        Transfer or disposal of SSBA

         (1)   An entity must report the following reportable events within 2 business days after the event takes place:

                (a)    a reportable event mentioned in paragraph 48 (1) (b) of the Act (entity disposes of its entire holdings of a security‑sensitive biological agent);

               (b)    a reportable event mentioned in paragraph 48 (1) (c) of the Act (disposal of toxins resulting in less than a reportable quantity);

                (c)    a reportable event mentioned in paragraph 48 (1) (e) of the Act (entity transfers a security‑sensitive biological agent).

         (2)   An entity must report a reportable event mentioned in regulation 3.17 (transferred security‑sensitive biological agent received) within 2 business days:

                (a)    for the receiving entity — after the entity verifies that it has received the security‑sensitive biological agent; and

               (b)    for the entity transferring a security‑sensitive biological agent to another of its facilities — after the entity verifies, at the facility, that it has received the security‑sensitive biological agent.

3.43        Unsuccessful transfer

                An entity must report a reportable event mentioned in regulation 3.18 (unsuccessful transfer of a security‑sensitive biological agent) within 2 business days:

                (a)    for the entity transferring the security‑sensitive biological agent:

                          (i)    after the entity becomes aware that the receiving entity is unable to verify that the transport to it of a security‑sensitive biological agent is successful; and

                         (ii)    if the entity is transferring the security‑sensitive biological agent to another of its facilities — after it is unable to verify at the facility that the transport of the security‑sensitive biological agent is successful; and

               (b)    for the receiving entity — after the entity is unable to verify that the transport to it of a security‑sensitive biological agent is successful.

Note   Verification, of a successful transport of a security‑sensitive biological agent, is provided for under Part 6 of the SSBA Standards: see paragraph 3.18 (1) (d).

3.44        Loss, theft and unauthorised access etc

         (1)   An entity must report the following reportable events within 2 business days after the entity becomes aware of the event:

                (a)    a reportable event mentioned in paragraph 48 (1) (f) of the Act (security‑sensitive biological agent is lost or stolen);

               (b)    a reportable event mentioned in paragraph 48 (1) (g) of the Act (unauthorised access to a security‑sensitive biological agent);

                (c)    a reportable event mentioned in regulation 3.20 (unauthorised handling of a security‑sensitive biological agent);

               (d)    a reportable event mentioned in regulation 3.21 (unauthorised access to sensitive information);

                (e)    a reportable event mentioned in regulation 3.22 (attempted theft of a security‑sensitive biological agent);

                (f)    a reportable event mentioned in subregulation 3.23 (1) (attempt to access a security‑sensitive biological agent);

                (g)    a reportable event mentioned in subregulation 3.23 (2) (attempt to handle a security‑sensitive biological agent);

                (h)    a reportable event mentioned in regulation 3.24 (attempt to access sensitive information);

                 (i)    a reportable event mentioned in regulation 3.25 (accidental release of a security‑sensitive biological agent);

                (j)    a reportable event mentioned in regulation 3.26 (persons affected by a security‑sensitive biological agent).

         (2)   An entity must report a reportable event mentioned in regulation 3.19 (transferred security‑sensitive biological agent not received) within 2 business days:

                (a)    for the receiving entity — after the entity becomes aware that the transferred security‑sensitive biological agent is lost in transit; or

               (b)    for the entity transferring the security‑sensitive biological agent:

                          (i)    after the entity becomes aware that the security‑sensitive biological agent transported to another entity is lost in transit; and

                         (ii)    if the entity is transferring the security‑sensitive biological agent to another of its facilities — after the entity becomes aware, at the facility, that the security‑sensitive biological agent is lost in transit.

Note   A security‑sensitive biological agent that an entity attempts to transfer, and that is subsequently lost in transit, is reportable by the entity transferring the security‑sensitive biological agent under paragraph 48 (1) (f) of the Act.

3.45        Particulars — responsible officer and deputy responsible officer

                An entity must report the following reportable events within 2 business days after the event takes place:

                (a)    a reportable event mentioned in paragraph 3.27 (2) (b) (change in contact details of the responsible officer and deputy responsible officer);

               (b)    a reportable event mentioned in paragraph 3.27 (2) (c) (person ceases to be the responsible officer);

                (c)    a reportable event mentioned in paragraph 3.27 (2) (d) (person ceases to be the deputy responsible officer);

               (d)    a reportable event mentioned in paragraph 3.27 (2) (e) (appointment of a responsible officer or deputy responsible officer).

3.45A      Events that must be reported to police

                For section 48A of the Act, the following events are prescribed:

                (a)    unauthorised access to a security-sensitive biological agent, within the meaning of regulation 3.15;

               (b)    the event mentioned in paragraph 3.18 (1) (d);

                (c)    the event mentioned in paragraph 3.19 (1) (d);

               (d)    the event mentioned in subregulation 3.20 (1);

                (e)    the event mentioned in regulation 3.21;

                (f)    the event mentioned in regulation 3.22;

                (g)    the event mentioned in subregulation 3.23 (1);

                (h)    the event mentioned in subregulation 3.23 (2);

                 (i)    the event mentioned in regulation 3.24.

3.45B     Period for reporting reportable events to police

                For subsection 48A (3) of the Act, the period is the period ending 24 hours after the registered entity became aware that the reportable event had occurred.

Subdivision 3.5.3        Reporting events for a period

3.46        Definitions

         (1)   In this Subdivision:

year means a calendar year.

         (2)   A tier 1 agent is a security‑sensitive biological agent that is identified as being a tier 1 agent in the List of Security‑sensitive Biological Agents.

         (3)   A tier 2 agent is a security‑sensitive biological agent that, after 31 January 2010, is identified as being a tier 2 agent in the List of Security‑sensitive Biological Agents.

3.47        Reportable events to which this Subdivision applies

                The following are the reportable events to which this Subdivision applies:

                (a)    a reportable event mentioned in subregulation 3.27 (1) (details of an entity);

               (b)    a reportable event mentioned in paragraph 3.27 (2) (a) (details of a facility of an entity).

3.48        Tier 1 agents — reporting periods

         (1)   The reporting periods for reportable events about tier 1 agents are as follows:

                (a)    the period commencing on 1 April in a year and ending on 30 September in the year (the first reporting period);

               (b)    the period commencing on 1 October in a year and ending on 31 March in the following year (the second reporting period).

         (2)   The due date for a report about a reportable event is:

                (a)    for a reportable event that occurs in the first reporting period — 31 October in the year when the first reporting period ends; or

               (b)    for a reportable event that occurs in the second reporting period — 30 April in the year when the second reporting period ends.

3.49        Tier 2 agents — reporting period

         (1)   The reporting period for a reportable event about a tier 2 agent:

                (a)    commences on 1 April in a year; and

               (b)    ends on 31 March in the following year.

         (2)   The due date for a report about a reportable event is 30 April in the year when the reporting period ends.

3.50        When entity must report

         (1)   An entity must report a reportable event mentioned in regulation 3.47.

         (2)   For an event that concerns a security‑sensitive biological agent that is a tier 1 agent, the entity must report the event:

                (a)    if it occurs during a first reporting period — before the end of the day described as the due date in paragraph  3.48 (2) (a); or

               (b)    if it occurs during a second reporting period — before the end of the day described as the due date in paragraph 3.48 (2) (b).

         (3)   For an event that concerns a security‑sensitive biological agent that is a tier 2 agent, the entity must report the event before the end of the day described as the due date in subregulation 3.49 (2).

         (4)   If the entity handles a tier 1 agent (whether or not it also handles a tier 2 agent), a reportable event mentioned in regulation 3.47 is taken to be an event that concerns a security‑sensitive biological agent that is a tier 1 agent.

         (5)   A reportable event mentioned in regulation 3.47 is taken to be an event that concerns a security‑sensitive biological agent that is a tier 2 agent if:

                (a)    the entity handles a tier 2 agent; and

               (b)    subregulation (4) does not apply to the entity.

         (6)   An entity must submit a single report to the Secretary for:

                (a)    a first reporting period that applies to the entity under paragraph (2) (a); or

               (b)    a second reporting period that applies to the entity under paragraph (2) (b); or

                (c)    a reporting period that applies to the entity under subregulation (3).

3.51        Periodic nil reporting

         (1)   For subparagraph 48 (1) (i) (i) of the Act, the following periods are prescribed:

                (a)    for a registered entity handling tier 1 agents — each period mentioned in subregulation 3.48 (1);

               (b)    for a registered entity handling tier 2 agents — the period is the period mentioned in subregulation 3.49 (1).

         (2)   For subparagraph 48 (1) (i) (ii) of the Act, the reportable events are the events mentioned in subregulations 3.27 (1) and (2).

         (3)   The due date for a report to which this regulation applies is:

                (a)    for a registered entity handling tier 1 agents — the dates mentioned in subregulation 3.48 (2); and

               (b)    for a registered entity handling tier 2 agents — the date mentioned in subregulation 3.49 (2).

Division 3.7           Miscellaneous

3.70        Identity cards

                For paragraph 64 (2) (a) of the Act, an identity card issued to an inspector must be in a form that contains the following information:

                (a)    the full name of the inspector;

               (b)    a statement that the person to whom the card is issued is appointed under subsection 63 (1) of the Act;

                (c)    for the photograph required under paragraph 64 (2) (b) of the Act, an image showing the inspector’s full face, head and shoulders;

               (d)    the date the card was issued;

                (e)    the date the card expires.

Note   Paragraph 64 (2) (b) of the Act provides that an identity card issued to an inspector must contain a recent photograph of the inspector.

3.71        Confidentiality of information

Intelligence agency

         (1)   For paragraph 85 (1) (a) of the Act, the Australian Security Intelligence Organisation is prescribed.

Law enforcement agencies

         (2)   For paragraph 85 (1) (b) of the Act, the following agencies are prescribed:

                (a)    the Australian Federal Police;

               (b)    the police force of each of the States and Territories.

Note   The Australian Federal Police operates the Australian Chemical, Biological, Radiological and Nuclear Data Centre.


Notes to the National Health Security Regulations 2008

Note 1

The National Health Security Regulations 2008 (in force under the National Health Security Act 2007) as shown in this compilation comprise Select Legislative Instrument 2008 No. 55 amended as indicated in the Tables below.

Table of Instruments

Year and
Number

Date of
FRLI registration

Date of
commencement

Application, saving or
transitional provisions

2008 No. 55

14 Apr 2008 (see F2008L00556)

15 Apr 2008

 

2008 No. 269

18 Dec 2008 (see F2008L04266)

Rr. 1–3 and Schedule 1: 31 Jan 2009 (see r. 2 (a) and F2008L04297)
Schedule 2: 1 July 2009

2009 No. 373

16 Dec 2009 (see F2009L03991)

31 Jan 2010 (see r. 2 and F2009L03993)

2010 No. 128

18 June 2010 (see F2010L01071)

19 June 2010

Table of Amendments

ad. = added or inserted      am. = amended      rep. = repealed      rs. = repealed and substituted

Provision affected

How affected

Part 1

 

Heading to Part 1.................

ad. 2008 No. 269

R. 1
Renumbered r. 1.01.........


2008 No. 269

R. 2
Renumbered r. 1.02.........


2008 No. 269

Heading to r. 3......................

rs. 2008 No. 269

R. 3
Renumbered r. 1.03........


2008 No. 269

R. 1.03....................................

am. 2008 No. 269; 2010 No. 128

Part 2

 

Heading to Part 2.................

ad. 2008 No. 269

R. 4
Renumbered r. 2.01........


2008 No. 269

Part 3

 

Division 3.1

 

R. 3.01....................................

ad. 2008 No. 269

 

am. 2008 No. 269

Division 3.2

 

R. 3.02....................................

ad. 2008 No. 269

R. 3.03....................................

ad. 2008 No. 269

R. 3.04....................................

ad. 2008 No. 269

R. 3.05....................................

ad. 2008 No. 269

 

rs. 2010 No. 128

Heading to r. 3.06.................

rs. 2010 No. 128

R. 3.06....................................

ad. 2008 No. 269

 

am. 2010 No. 128

R. 3.07....................................

ad. 2010 No. 128

R. 3.08....................................

ad. 2010 No. 128

Division 3.4

 

Heading to Div. 3.4...............

rs. 2008 No. 269

Subdivision 3.4.1

 

R. 3.15....................................

ad. 2008 No. 269

Subdivision 3.4.2

 

R. 3.16....................................

ad. 2008 No. 269

 

rs. 2008 No. 269

R. 3.17....................................

ad. 2008 No. 269

 

am. 2009 No. 373; 2010 No. 128

R. 3.18....................................

ad. 2008 No. 269

 

am. 2009 No. 373; 2010 No. 128

R. 3.19....................................

ad. 2008 No. 269

 

am. 2009 No. 373; 2010 No. 128

R. 3.20....................................

ad. 2008 No. 269

R. 3.21....................................

ad. 2008 No. 269

R. 3.22....................................

ad. 2008 No. 269

R. 3.23....................................

ad. 2008 No. 269

R. 3.24....................................

ad. 2008 No. 269

R. 3.25....................................

ad. 2008 No. 269

R. 3.26....................................

ad. 2008 No. 269

 

rs. 2010 No. 128

R. 3.27....................................

ad. 2008 No. 269

 

am. 2008 No. 269

Division 3.5

 

Subdivision 3.5.1

 

R. 3.40....................................

ad. 2008 No. 269

Subdivision 3.5.2

 

R. 3.41....................................

ad. 2008 No. 269

R. 3.42....................................

ad. 2008 No. 269

 

am. 2008 No. 269

R. 3.43....................................

ad. 2008 No. 269

Note to r. 3.43........................

am. 2009 No. 373; 2010 No. 128

R. 3.44....................................

ad. 2008 No. 269

 

rs. 2008 No. 269

 

am. 2010 No. 128

R. 3.45....................................

ad. 2008 No. 269

R. 3.45A..................................

ad. 2009 No. 373

R. 3.45B.................................

ad. 2009 No. 373

Subdivision 3.5.3

 

R. 3.46....................................

ad. 2008 No. 269

R. 3.47....................................

ad. 2008 No. 269

 

am. 2009 No. 269

R. 3.48....................................

ad. 2008 No. 269

R. 3.49....................................

ad. 2008 No. 269

R. 3.50....................................

ad. 2008 No. 269

R. 3.51....................................

ad. 2009 No. 373

Division 3.7

 

R. 3.70....................................

ad. 2008 No. 269

R. 3.71....................................

ad. 2008 No. 269