Introduction – the process and form
2.1 An organisation can apply for accreditation by making a written application to the Regulator. Application forms can be obtained from the OGTR or can be downloaded from the website:
2.2 Applications must address a number of required technical and procedural matters. These matters are set out in the Guidelines and in the application form. Copies of the Guidelines can be downloaded from the OGTR website.
2.3 The Regulator considers the level of compliance with the technical and procedural requirements outlined in the Guidelines in determining whether to accredit an organisation.
2.4 The Regulator must decide whether or not to grant accreditation within 90 working days. If the Regulator requests further information in the course of consideration of the application, the 90 day time limit is suspended while the Regulator is waiting for information to be provided.
2.5 The application form requests information about the suitability of organisations to hold accreditation. It also makes provision for applications to be made in respect of organisations establishing at least one IBC of their own or arranging access to another organisation’s IBC.
2.6 Because the accreditation application form covers all the matters required to be addressed, if the form is completed correctly, all relevant matters will be addressed.
Organisations must be suitable to be accredited
2.7 Suitability to hold accreditation is a mandatory, threshold test that all accredited organisations must satisfy. An organisation will not be accredited by the Regulator unless the Regulator is satisfied that the organisation is a suitable organisation.
2.8 In general terms, a suitable organisation is an organisation that is considered to be reasonably capable of conducting dealings with GMOs safely. Another way of describing a suitable organisation might be to describe them as ‘fit and proper’ to conduct dealings with GMOs.
2.9 Concepts of honesty, knowledge and ability are connoted by the expression ‘suitable’.
2.10 Suitability is a broad assessment and the Regulator may have regard to any relevant information.
2.11 The range of matters to which the Regulator may have regard may extend beyond the organisation itself. For example, in considering the suitability of a wholly owned subsidiary company, the Regulator might, depending on the circumstances, investigate the reputation of the parent company and the closeness of the relationship between the organisation and its parent.
2.12 If an applicant previously had a GMO licence suspended or revoked by the Regulator, this would be relevant to the Regulator’s assessment of whether the person is a suitable person. An organisation’s conduct in connection with other regulation might also be relevant.
2.13 If an organisation has relevant convictions, those convictions must be set out in the application form.
2.14 A relevant conviction may prevent an organisation from obtaining accreditation.
2.15 An organisation must also list any revocation, suspension or cancellation of a licence or permit (however described) held by the organisation under a law of the Commonwealth, a State or a foreign country relating to the health and safety of people or the environment.
2.16 An organisation must include information about the revocation, suspension or cancellation of licences and permits issued by:
- The Therapeutic Goods Administration
- DAFF Biosecurity;
- Food Standards Australia New Zealand;
- National Industrial Chemical Notification and Assessment Scheme;
- Australian Pesticides and Veterinary Medicines Authority; or
- Department of Sustainability, Environment, Water, Population and Communities.
2.18 The revocation, suspension or cancellation of an instrument like those described above may prevent an organisation from obtaining accreditation.
Requirements in respect of IBCs
2.19 Applicant organisations are required to establish at least one IBC of their own, or access another organisation’s IBC.
2.20 Accredited organisations are required to continue to have access to at least one IBC of their own, or another organisation’s IBC.
2.21 An applicant organisation is able to obtain accreditation if it can demonstrate, in respect of the IBC, that:
- the membership of the IBC has the collective technical and scientific expertise to review and assess all the matters that are likely be put to it by the organisation;
- the members of the IBC are appropriately indemnified; and
- at least one of the members of the IBC is independent.
A. IBCs must have technical expertise to assess and review matters
2.23 In order to perform its functions satisfactorily, an IBC will ideally have, within its membership, a breadth of relevant expertise both to understand and analyse hazards and risks associated with the particular dealings and to provide expert commentary on those risks including, where relevant, any containment measures for GMOs involved in the dealings and the classification of the dealings with the GMO in accordance with the Regulations.
2.24 The scientific and technical skills that will be necessary to enable an IBC to satisfactorily perform its functions will vary, depending on the type of research being conducted.
2.25 For example, an IBC considering gene technology work on potentially pathogenic micro-organisms might reasonably include a microbiologist and a biological safety expert, and would need to have expertise in the physical containment of organisms and in the nature of the dealings or research being conducted.
2.26 An IBC overseeing tests of crop performance of GMOs might have a membership that includes, among other expertise, molecular biology, entomology, plant pathology, agronomy and ecology.
2.27 IBCs that oversee contained facilities that are certified to physical containment level 3, 4 or level 1 or 2 Large Scale facilities, will not ordinarily meet the criterion for technical expertise unless the IBC has expertise in physical containment of organisms. This comprises:
- understanding the building structural requirements, equipment and procedural requirements;
- relevant training or experience in the design and testing of biological safety facilities and equipment;
- relevant training or experience with proper procedures for the safety of persons and the containment of organisms; and
- knowledge of the biology and life cycles of organisms being used within the facilities.
- take stock of the scientific, technical and other professional skills of the membership of the IBC and the kinds of matters likely to be put to the IBC by the organisation; and
- document how those skills and experience will enable the IBC to efficiently and effectively assess and review the information that is likely to be put before it by the organisation.
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B. IBC must have an independent member
2.30 The intention in requiring an independent member is to include someone who can exercise unfettered and independent judgement in relation to their participation in the IBC.
2.31 To address this criterion, an applicant must make a statement in the application form that at least one member of the IBC has no ongoing, substantive association (including personal, pecuniary or research interests) with matters likely to be considered by the IBC.
2.32 While it is not a requirement, the Regulator encourages members who satisfy the independence criterion to be free of any business or other relationship with the organisation that could materially interfere with the exercise of unfettered and independent judgement in contributing to decisions made by the IBC, including a relationship of employment.
C. IBC members must be appropriately indemnified
2.33 To address this criterion, an applicant must make a statement in the application form that all IBC members consider they are appropriately indemnified.
2.34 The statement can be made by the organisation itself, in terms as simple as ‘the indemnity arrangements in place in respect of all IBC members, as regards the organisation, are satisfactory to them’, or even ‘All IBC members are appropriately indemnified’.
2.35 Alternatively, if the organisation prefers, it can provide written statements from each IBC member that the indemnity arrangements in place, as between the IBC member and the organisation, are satisfactory.
2.36 An indemnification arrangement is appropriate if it is in place and satisfactory to the IBC member covered by it. That is, indemnity arrangements are satisfactory if the IBC members consider that they are protected from legal liability for damages, as a result of their performing functions as an IBC member.
2.37 IBC members and organisations are encouraged to obtain their own separate legal advice in coming to arrangements between them.
2.38 IBCs provide advice and assistance to organisations on matters that were historically not regulated, but are now regulated under the Act.
2.39 To address this, indemnity requirements benefiting IBC members are a requirement in the Guidelines. The requirement for indemnity arrangements provides comfort to IBC members so that they continue to provide a valuable service to organisations.
2.40 Implementing prescribed, standard indemnity arrangements between IBC members and organisations has been considered on a number of occasions. However, because the indemnity requirement is included to provide comfort to IBC members via what is essentially a private arrangement between an IBC member and an organisation, the Guidelines do not prescribe particular indemnity arrangements. If an IBC member is satisfied, the objective of the indemnity requirement is achieved.
2.41 Indemnities can therefore take many different forms, depending on a range of matters, including the nature and extent of the activities they are made in contemplation of, and people’s attitudes towards them. These arrangements provide flexibility to IBC members and organisations to settle arrangements that are satisfactory to them by not prescribing any particular indemnity arrangement (or a minimum requirement).
Requirements for use of other organisations’ IBCs
2.42 For a variety of reasons, some organisations are not able to establish their own IBCs. For example many small institutions are not able to fund IBCs and many collaborative research arrangements exist where there is limited or no access to internal IBCs. It is still possible for these organisations to become accredited.
2.43 Organisations that have established arrangements to use an IBC belonging to another organisation can seek accreditation from the Regulator.
2.44 An applicant is able to obtain accreditation if they can demonstrate, in respect of the IBC of the other organisation, that:
- the other organisation has consented, in writing (on page 21 of the application form), to its IBC being accessed and used by the organisation seeking accreditation;
- the organisation that maintains the IBC has declared that:
- the members of its IBC are appropriately indemnified, as regards the organisation seeking accreditation; and
- the membership of the IBC includes at least one independent member.
- the membership of the IBC has the collective technical and scientific expertise to review and assess all the matters that are likely be put to it by the organisation seeking accreditation.
2.46 In all other respects, the information requirements are equivalent to those for applications in respect of IBCs created by the organisation. Applicants should refer back to earlier information in this explanatory document about skills and experience and indemnification requirements.
Helpful Hints – Applications for Accreditation
2.47 If the Regulator requests further information from you in the course of considering an application, please provide the information promptly. Failure to do so may slow the consideration of your application, or even result in its refusal.
2.48 Generally, the Regulator must make a decision on an application for accreditation within 90 working days.
2.49 But if the Regulator requests further information from you, the 90 day time frame will be suspended until the information is provided.
2.50 If the Regulator stipulates a timeframe within which any requested information must be provided, and the information is not provided within that time and without reasonable excuse, the Regulator may refuse the application.
2.51 Organisations should not be discouraged from highlighting aspects of applications that are not fully compliant with the Guidelines, particularly if they also have proposals for how full compliance, or equivalent compliance, might be achieved by the organisation in a reasonable period following accreditation. The Regulator is empowered to grant accreditation subject to conditions. In appropriate circumstances, the Regulator may consider imposing conditions at the time of accreditation allowing an organisation to work towards reaching full compliance.
2.52 Decisions by the Regulator to refuse an application for accreditation, to impose conditions, or to vary, suspend or cancel accreditation are “reviewable decisions” under the Act. This means that an applicant may seek review of the decision by the Administrative Appeals Tribunal (AAT).
2.53 The AAT undertakes merit reviews of administrative decisions. The AAT may:
stay the operation or implementation of a decision until the AAT hearing;
- affirm the decision made by the decision maker;
- vary the decision;
- set aside the decision;
- substitute its own decision; or
- remit the matter to the original decision maker with directions or recommendations for re-making the decision.Top of page