Part 7Certification and accreditation

Part 7—Certification and accreditation 82—Simplified outline (a) establishes a system under which the Regulator may certify facilities to specified containment levels in accordance with guidelines issued by the Regulator. Licence conditions, or conditions to which an emergency dealing determination is subject, can require that facilities be certified to specified containment levels (see Division 2); (b) enables the Regulator to accredit organisations in accordance with accreditation guidelines issued by the Regulator. Licence conditions, or conditions to which an emergency dealing determination is subject, can specify that dealings must be supervised by an Institutional Biosafety Committee established by an accredited organisation (see Division 3). Division 2—Certification 83—Application for certification (1) A person may apply to the Regulator for certification of a facility to a particular containment level under this Division. (2) The application must be in writing and must contain such information as the Regulator requires. The conditions of a licence, or conditions to which an emergency dealing determination is subject, may require that a facility be certified under this Division. (3) The application must be accompanied by the application fee (if any) prescribed by the regulations. 84—When the Regulator may certify the facility The Regulator may, by written instrument, certify the facility to a specified containment level if the facility meets the containment requirements specified in guidelines issued by the Regulator under section 90. 85—Regulator may require applicant to give further information (1) The Regulator may, by notice in writing, require an applicant for certification of a facility to give the Regulator such further information in relation to the application as the Regulator requires. 86—Conditions of certification The certification of a facility is subject to the following conditions: (a) any conditions imposed by the Regulator at the time of certification; (b) any conditions imposed by the Regulator under section 87 after certification; (c) any conditions prescribed by the regulations. 87—Variation of certification (1) The Regulator may, at any time, by notice in writing given to the holder of the certification, vary the certification of a facility. (2) Without limiting subsection (1), the Regulator may— (a) impose additional conditions; or (b) remove or vary conditions that were imposed by the Regulator. 88—Suspension or cancellation of certification The Regulator may, by notice in writing, suspend or cancel the certification of a facility if the Regulator believes on reasonable grounds that a condition of the certification has been breached. 89—Regulator to notify of proposed suspension, cancellation or variation (1) Before suspending, cancelling or varying a certification under this Division, the Regulator must give written notice of the proposed suspension, cancellation or variation to the holder of the certification. (a) must state that the Regulator proposes to suspend, cancel or vary the certification; and (b) may require the holder of the certification to give to the Regulator any information of a kind specified in the notice that is relevant to the proposed suspension, cancellation or variation; and (c) may invite the holder of the certification to make a written submission to the Regulator about the proposed suspension, cancellation or variation. (3) The notice must specify a period within which the holder of the certification— (4) In considering whether to suspend, cancel or vary a certification, the Regulator must have regard to any submission made under subsection (2)(c). (5) This section does not apply to a suspension, cancellation or variation requested by the holder of the certification. (6) This section does not apply to a suspension, cancellation or variation of a certification if the Regulator considers that the suspension, cancellation or variation is necessary in order to avoid an imminent risk of death, serious illness, serious injury or serious damage to the environment. (7) This section does not apply to a variation of a licence if the Regulator is satisfied that the variation is of minor significance or complexity. 89A—Transfer of certification (1) The holder of a certification and another person (the transferee) may jointly apply to the Regulator for the certification to be transferred from the holder of the certification to the transferee. (2) The application must be in writing and must contain— (3) The Regulator must not transfer the certification unless the Regulator is satisfied that, if the certification is transferred, any conditions to which the certification is subject will continue to be met. (4) The Regulator must give written notice of his or her decision on the application to the holder of the certification and the transferee. (5) If the Regulator decides to transfer the certification— (a) the transfer takes effect on the date specified in the notice; and (b) the certification continues in force; and (c) the certification is subject to the same conditions as those in force immediately before the transfer. 90—Guidelines (1) The Regulator may, by written instrument, issue technical or procedural guidelines about the requirements for the certification of facilities to specified containment levels. (2) The Regulator may, by written instrument, vary or revoke the guidelines. Division 3—Accredited organisations 91—Application for accreditation (1) A person may apply to the Regulator for accreditation of an organisation as an accredited organisation under this Division. 1 The conditions of a licence may require supervision of dealings by an Institutional Biosafety Committee (see section 62(2)(m)) and the regulations may require such supervision of notifiable low risk dealings (see section 75(2)(c)). 2 The conditions to which an emergency dealing determination is subject may require supervision of dealings by an Institutional Biosafety Committee (see section 72D(2)(t)). (2) The application must be in writing, and must contain such information as the Regulator requires. 92—Regulator may accredit organisations (1) The Regulator may, by written instrument, accredit an organisation as an accredited organisation. (2) In deciding whether to accredit an organisation, the Regulator must have regard to— (a) whether the organisation has established an Institutional Biosafety Committee in accordance with written guidelines issued by the Regulator under section 98; and (b) if the organisation has established an Institutional Biosafety Committee—whether the organisation will be able to maintain the Institutional Biosafety Committee in accordance with such guidelines; and (c) if the organisation has established an Institutional Biosafety Committee—whether the organisation has appropriate indemnity arrangements for its Institutional Biosafety Committee members; and (ca) if the organisation has not established an Institutional Biosafety Committee as mentioned in paragraph (a)—whether the organisation will be in a position to use an Institutional Biosafety Committee established by an accredited organisation; and (d) any other matters specified in such guidelines. 93—Regulator may require applicant to give further information (1) The Regulator may, by notice in writing, require an applicant for accreditation of an organisation to give the Regulator such further information in relation to the application as the Regulator requires. 94—Conditions of accreditation The accreditation of an accredited organisation is subject to the following conditions: (a) any conditions imposed by the Regulator at the time of accreditation; (b) any conditions imposed by the Regulator under section 95 after accreditation; (c) any conditions prescribed by the regulations. 95—Variation of accreditation (1) The Regulator may, at any time, by notice in writing given to an accredited organisation, vary the organisation's accreditation. (2) Without limiting subsection (1), the Regulator may— (a) impose additional conditions; or (b) remove or vary conditions that were imposed by the Regulator. 96—Suspension or cancellation of accreditation The Regulator may, by notice in writing, suspend or cancel the accreditation of an organisation if the Regulator believes on reasonable grounds that a condition of the accreditation has been breached. 97—Regulator to notify of proposed suspension, cancellation or variation (1) Before suspending, cancelling or varying an accreditation under this Division, the Regulator must give written notice of the proposed suspension, cancellation or variation to the holder of the accreditation. (a) must state that the Regulator proposes to suspend, cancel or vary the accreditation; and (b) may require the holder of the accreditation to give to the Regulator any information of a kind specified in the notice that is relevant to the proposed suspension, cancellation or variation; and (c) may invite the holder of the accreditation to make a written submission to the Regulator about the proposed suspension, cancellation or variation. (3) The notice must specify a period within which the holder of the accreditation— (4) In considering whether to suspend, cancel or vary an accreditation, the Regulator must have regard to any submission made under subsection (2)(c). (5) This section does not apply to a suspension, cancellation or variation requested by the holder of the accreditation. (6) This section does not apply to a suspension, cancellation or variation of an accreditation if the Regulator considers that the suspension, cancellation or variation is necessary in order to avoid an imminent risk of death, serious illness, serious injury or serious damage to the environment. (7) This section does not apply to a variation of an accreditation if the Regulator is satisfied that the variation is of minor significance or complexity. 98—Guidelines (1) The Regulator may, by written instrument, issue technical or procedural guidelines in relation to requirements that must be met in order for an organisation to be accredited under this Division. (2) The guidelines may relate to, but are not limited to, matters concerning the establishment and maintenance of Institutional Biosafety Committees. (3) The Regulator may, by written instrument, vary or revoke the guidelines.