Introduction


3.1 Upon accreditation, the Regulator issues an instrument of accreditation to the organisation. The instrument denotes that the organisation has met the requirements for accreditation.

3.2 The instrument sets out:
  • the name of the accredited organisation; and
  • any conditions of accreditation.
3.3 A range of conditions will generally be imposed on an organisation at the time of accreditation. Organisations must comply with any conditions imposed, on an ongoing basis, in order to maintain the accreditation.

3.4 Conditions imposed at the time of accreditation are designed to ensure that compliance with the standards of review is maintained by the organisation on an ongoing basis. They also establish minimum standards for the organisation and the relevant IBC on a range of matters affecting the IBC and its use by the organisation.

3.5 As a result, accredited organisations will be required to:
  • develop and implement processes and procedures to address conflicts of interest;
  • keep satisfactory records; and
  • prepare and submit annual reports and other notices to the Regulator.
3.6 Depending on the circumstances, the Regulator may also impose other conditions at the time of accreditation.

3.7 The usual conditions are outlined in the Guidelines; some of the usual conditions are also explained in more detail below.

Usual conditions of accreditation

A.Continuing requirements to address conflicts of interest


3.8 There may be occasions where a proposal submitted by an organisation arises from the recommendations of an IBC where one or more of the members of the IBC have a close involvement in the matter being considered. This may give rise to a conflict of interest, or a perception of a conflict of interest.

3.9 For the purposes of the Guidelines, a ‘conflict of interest’ in a matter includes:
  • a direct financial interest;
  • any indirect interest, for example a financial benefit accruing to a close relative or partner of the member;
  • a non-financial interest, for example a person may have an interest in a matter as a result of an affiliation or membership of an interest group or organisation;
  • any interest that could be viewed as a possible conflict of interest; or
  • any combination of the above interests.
3.10 It is the Regulator’s policy to impose conditions at the time of accreditation requiring accredited organisations to have effective mechanisms in place to address conflicts of interest on the part of IBC members. In most cases, these conditions will:
  • require IBC members to declare conflicts of interest, whether direct or indirect, pecuniary or otherwise, perceived or real;
  • require declared conflicts to be recorded in the minutes of IBC meetings along with any measures taken to address the conflict; and
  • enable IBCs to decide for themselves whether, in a particular instance, a conflict of interest is so significant that an IBC member be absented from further participation in a matter before the IBC.
3.11 The Guidelines contain draft conditions of accreditation dealing with conflicts of interest. The draft clauses are likely to form the basis of any conditions actually imposed.

B. Continuing requirements to keep records and submit reports to the Regulator

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3.12 Good records, good record keeping practices and good reporting practices are all important tools in the proper management of dealings with GMOs. For example, in the event of a breach of containment, proper records and reporting may be essential to ensuring that the causes and impacts of the breach can be identified and redressed.

3.13 It is the Regulator’s policy to require accredited organisations to maintain a minimum standard of good record keeping and reporting practices. In most cases, these conditions will require:
  • records of meetings of IBCs to be kept for a minimum of 3 years from the date of each meeting;
  • records of meetings to record all conflicts of interest declared to the IBC;
  • records of inspections of certified facilities to be kept for a minimum of 5 years from the date of the inspection;
  • records of assessment of NLRDs to be kept for a minimum of 8 years after the date of assessment by the IBC;
  • annual reports to be submitted to the Regulator; and
  • notice to be given, in writing, to the Regulator within 30 days if the accredited organisation:
  • wishes to access or establish an IBC other than the IBC(s) identified in their application;
  • disbands or ceases to use an IBC;
  • changes its primary contact or the contact details for the primary contact;
  • changes its IBC contact or the contact details for its IBC contact (where the IBC is the accredited organisation’s own IBC);
  • changes the its CEO (or equivalent) or the contact details for the CEO (or equivalent);
  • changes its IBC chair or the contact details for its IBC chair (where the IBC is the accredited organisation’s own IBC);
  • changes its name or ownership;
  • is convicted of an offence against a law of the Commonwealth, a State or a foreign country relating to the health and safety of people or the environment and punishable by a fine of $5000 or more; or
  • has had 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, revoked, suspended or cancelled.
3.14 All records must be available for inspection by the Regulator upon request.

3.15 It is the Regulator’s policy that accreditation conditions, in respect of annual reports, will require them to:
  • report for the period 1 July to 30 June in the following year (the reporting period);
  • be submitted by 30 September each year; and
  • list all NLRDs assessed by an IBC in the reporting period.
3.16 The Regulator circulates a form for annual reporting by accredited organisations. In most cases, accredited organisations can satisfy annual reporting conditions of accreditation by filling out the form correctly and submitting it on time.

3.17 Accredited organisations should take special note that if they hold GMO licences, those licences may impose additional annual, or other, reporting obligations on them.

Monitoring and non-compliance with accreditation conditions


3.18 Accredited organisations are monitored by the Regulator to ensure that they are operating in accordance with any conditions of accreditation imposed on them. The Regulator also monitors, audits and inspects dealings with GMOs, to ensure that any conditions particular to certain dealings with GMOs are being observed.

3.19 The OGTR has programs for both routine (announced) and on-the-spot (unannounced) monitoring visits to accredited organisations to assess compliance with their conditions of accreditation. During monitoring visits, monitoring and compliance officers may ask to look at records, standard operating procedures and other documents held and used by the organisation.

3.20 Accredited organisations are encouraged to contact the OGTR if they find that they have not complied with their conditions of accreditation.

3.21 Where conditions of accreditation have not been met, the Regulator has recourse to the OGTR’s Monitoring Section and Compliance and Investigation Section protocols and the Compliance and Enforcement policy. Further information can be obtained from the OGTR website.

Variation of accreditation


3.22 To allow accreditations to adjust to changing circumstances, instruments of accreditation are able to be varied. The Regulator may impose additional conditions, remove or vary conditions previously imposed, either on the initiative of the Regulator or in response to a request.

3.23 If you consider that variations to your conditions of accreditation are necessary or desirable, you are welcome to contact the OGTR to discuss how changes to your accreditation might be made.

3.24 If circumstances arise such that the Regulator considers a variation of your accreditation is desirable, the Regulator will consult you in connection with the proposed variation before any variation decision is made.

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