Biological Agents and Toxins Act 2005 · 2020 Revised Edition · Part 6 · Approvals, Permits and Certification of Facilities
50. Approvals and permits
Feedback & supportLast amended by an amending law of 2023.
An application for any approval or permit required under this Act must be made to the Director‑General in such form and manner as the Director‑General may require and must be accompanied by —
approval
“approval” means an approval granted by the Director‑General under this Act;
such particulars, information and documents as the Director‑General may specify; and
if required by the Director‑General, a statutory declaration by the applicant verifying any information contained in or relating to the application.
An applicant for any approval required under this Act must, if required by the Director‑General or an enforcement officer, provide the Director‑General or enforcement officer access to the facility of the applicant in order that the Director‑General or enforcement officer may inspect such facility and observe the work processes and procedures undertaken thereat.
Upon considering an application made under subsection (1), the Director‑General may —
grant the approval or permit applied for, with or without conditions; or
refuse to grant the approval or permit applied for.
The Director‑General may at any time vary or revoke any of the existing conditions imposed under subsection (3)(a) or impose new conditions.
Where the Director‑General refuses to grant any approval or permit under subsection (3)(b), the Director‑General must, if requested to do so in writing by the applicant, state in writing the reasons for the Director‑General’s refusal.
An approval to possess any biological agent or toxin ceases to be valid upon the occurrence of any of the following events:
biological agent
“biological agent” means —(a)any micro-organism (including any bacterium, virus, fungus, rickettsia and parasite);(b)any infectious substance (including any prion); or(c)any component of a micro-organism or an infectious substance (but not including any toxin),that is capable of causing death, disease or other biological malfunction in a human;
upon the person to whom the approval has been granted ceasing to be the operator of the facility (whether certified or uncertified) specified in the approval;
where the facility in respect of which the approval has been granted is required under this Act to be a certified facility, upon that facility ceasing to be such a certified facility.
If the Director‑General has reason to believe that —
the grant of any approval or permit was obtained by fraud or misrepresentation;
the person to whom the approval or permit was granted has contravened, is contravening or is likely to contravene any provision of this Act or any condition imposed under subsection (3)(a) or (4); or
any activity carried out at the facility to which the approval or permit relates poses a risk to public health,the Director‑General may do all or any of the following:
suspend or cancel the approval or permit;
order any one or more of the following:
the immediate cessation of any activity involving any biological agent or toxin at the facility;
the destruction of any biological agent or toxin at the facility;
the decontamination of the facility;
the closure or cordoning off of the facility until such time as the Director‑General is satisfied that the facility may safely resume operation;
that any person who is or was at the facility (whether as a member of the staff of the facility or otherwise) and who may be or may have been exposed to any biological agent or toxin at the facility should —
undergo such medical examination and medical treatment at such place or hospital as the Director‑General may specify in the order; or
be quarantined at such place and for such period as the Director‑General may specify in the order.
The Director‑General may suspend or cancel any approval or permit without any prior notice of such suspension or revocation.
Where any approval or permit ceases to be valid or is suspended or cancelled, the Director‑General or an enforcement officer may seize any biological agent or toxin to which the approval or permit relates, and any other material arising out of any activity carried out in relation to or in connection with the biological agent or toxin to which the approval or permit relates.
enforcement officer
“enforcement officer” means any person appointed by the Director‑General to be an enforcement officer under section 3(2);
Any person who contravenes any order made by the Director‑General under subsection (7)(e) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both and, in the case of a continuing offence, to a further fine not exceeding $1,000 for every day or part of a day during which the offence continues after conviction.