Biological Agents and Toxins Act 2005 · 2020 Revised Edition · Part 5 · Duties and Obligations in Relation to Biological Agents and Toxins
39. Appointment of biosafety committee and biosafety co‑ordinator
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Every operator of a facility must, in accordance with such requirements as may be prescribed —
operator
“operator”, in relation to a facility, means the person who operates the facility or who has the management or control of the facility;
appoint a biosafety committee comprising the persons specified in the Sixth Schedule; and
appoint a biosafety co-ordinator.
The biosafety co-ordinator of a facility must undergo such training as the Director‑General may from time to time require.
facility
“facility” means any premises or conveyance that is being used for —(a)the storage of any biological agent or toxin; or(b)the carrying out of any activity involving any biological agent or toxin;
Subject to subsection (4), every operator of a facility must, before carrying out any of the following activities at the facility, obtain the advice of the biosafety committee as to the safety measures required for the carrying out of that activity:
biosafety committee
“biosafety committee” means a biosafety committee appointed under section 39;
any activity involving any biological agent or toxin;
the inactivation of any biological agent.
Nothing in subsection (3) requires the operator of a facility to obtain the advice of the biosafety committee in respect of an activity which the operator proposes to carry out at the facility if the proposed activity is of the same type and is to be carried out in the same manner as an activity in respect of which the operator had previously obtained the advice of the biosafety committee in accordance with that subsection and which had been carried out safely.
In order to properly advise the operator of a facility as to the safety measures required for the carrying out of any activity referred to in subsection (3) at the facility, the biosafety committee must —
conduct risk assessments in relation to the activity proposed to be carried out;
devise such measures for the management of the risks that may arise from the proposed activity; and
formulate such other policies, programmes and codes of practice as may be necessary for —
the proposed activity to be carried out safely at the facility; and
the training of staff who will be involved in the carrying out of the proposed activity.
An operator of a facility must not commence or allow the commencement of any activity involving any biological agent or toxin at the facility unless —
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;
the biosafety committee has determined that the proposed activity may be carried out safely at the facility;
the biosafety co-ordinator has implemented the measures, policies, programmes and codes of practice as devised or formulated by the biosafety committee under subsection (5); and
where the proposed activity involves the use of any biological agent inactivated at the facility, the biosafety committee has verified that the biological agent has been properly inactivated.
The biosafety committee must review every 2 years or earlier, as may be appropriate, all measures, policies, programmes and codes of practice devised or formulated by it under subsection (5), and must immediately inform the operator of the facility of any change to such measures, policies, programmes and codes of practice as the biosafety committee thinks necessary.
Where the biosafety committee has proposed changes to any existing measure, policy, programme or code of practice —
the biosafety co-ordinator of the facility must implement such changes as soon as possible within the timeframe stipulated by the biosafety committee; and
the operator of the facility must, if so advised by the biosafety committee, discontinue the activity to which the changes relate until such time as the biosafety co-ordinator has implemented those changes.