Subdivision 3.4.3Reportable events—when report must be given

Part 1—Preliminary

1.01 Name of Regulations

These Regulations are the National Health Security Regulations 2008.

1.02 Commencement

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).

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;