These frequently asked questions (FAQs) have been compiled from observations and common queries received in the office. The information will be updated periodically.

If you have any questions relating to Accreditation, IBCs or the administration of NLRDs, which are not addressed on this page, please email ogtr.applications@health.gov.au.

What are Primary and Secondary contacts? Are they authorised to request changes to a certification or licence?

The Primary contact is the person an organisation has nominated as the first point of contact for all communications from the OGTR. The Secondary contact is intended to be a back-up for the Primary contact. Both will be included in communications from the OGTR. Under the conditions of Accreditation, the OGTR must be advised of any changes to the contact persons, or their details.

Primary and Secondary contacts cannot request changes to a certification or licence unless they are also Authorised Persons for the purposes of that application. If the request to change a certification or licence was submitted using an online form, a declaration of authority is required for submission. For applications that do not have a relevant online form, or in other cases where a person may wish to be authorised, a form can be completed to authorise persons to act on behalf of an organisation. Authorised persons can be Primary or Secondary contacts, or neither. Authorised persons are not included in regular communications from the OGTR, unless they have another contact role i.e. Primary or Secondary contact.

In the event that a person, who is not listed in our records as an authorised person for that purpose, wishes to submit an application via a method other than online, they must state in their application that they are duly authorised to do so (if they indeed are). Without a statement of authority, the OGTR may not be able to receive an application.

There are different levels of “authorisation” that can be requested:

  • Authorisation for Secondary Applications for all instruments (Accr/Cert/DIR/DNIR)
  • Authorisation for Secondary Applications relating to an organisation’s Accreditation
  • Authorisation for Secondary Applications relating to all Certifications
  • Authorisation for Secondary Applications relating to all DNIRs
  • Authorisation for Secondary Applications relating to all DIRs
Note: Secondary Applications refer to requests to modify existing primary applications (i.e. Accr, Cert, DNIR, DIR), and include variation, suspension, lift of suspension, transfer and surrender applications.

The form to advise the OGTR of any changes to Primary, Secondary Contacts or Authorised persons is available by clicking this Form link.

Who notifies the Regulator of NLRDs assessed by an IBC?

  • Regulation 13C(1) requires a person or accredited organisation to provide the Regulator a record of any proposed dealings assessed by an IBC to be an NLRD.
  • The record of an NLRD must be provided:
          in a form approved by the Regulator – the reporting form and instructions for completing are available on the NLRD Documents and Forms page; and
          at any time from the date of assessment until the 30th September of the following financial year.
  • In the event that the organisation is accredited under the Gene Technology Act 2000, reporting of NLRDs must occur prior to an accredited organisation submitting their annual report to the Regulator.
  • The notification of an NLRD should come from the person or organisation who submitted the proposal, not from the IBC that assessed it, unless they are authorised to do so on behalf of the organisation.
  • The role of the IBC is to assess whether or not a proposal submitted by a person or organisation is an NLRD, assess the suitability of people and facilities proposed for the dealings, and to give a copy of the record of assessment to the person/organisation who submitted the proposal.

    What if we haven’t reported new NLRDs from previous financial years?

  • The person or organisation who submitted the proposal must notify the Regulator of the NLRD from a previous financial year as soon as possible.
  • It is the responsibility of the person or organisation to ensure that all NLRDs are notified by the 30th of September following the financial year in which they were assessed (e.g. if they were assessed in 2019-2020 they must be notified by 30th September 2020) and prior to the accredited organisation's annual report.
  • If an NLRD was assessed in a previous financial year, and not yet notified to the Regulator, it must be notified as soon as possible. In this case, the NLRD reporting form will require an explanation as to why the NLRD was not notified within the required timeframe.

    Can we extend, transfer or amend a NLRD in any way?

    The existing record of assessment (RoA) for a NLRD cannot be changed i.e. varied, extended, transferred or amended. A new assessment must be conducted and a RoA prepared to include elements not in the original assessment. This ensures there is clear understanding between NLRD proponents, IBCs and the Regulator about the scope of each NLRD, which supports organisational oversight of research and OGTR’s monitoring and compliance activities. When preparing a RoA, consideration should be given to what is included in the RoA so as to accommodate changing circumstances. Guidance on making a RoA to achieve this, such as the use of class of person or facilities, is available (see the NLRD and Documents and Forms page).

    Specific examples of amendments that would require a new RoA include:
    • Changes to person(s) considered appropriate to undertake the dealings, if not defined by a class of person;
    • Changes to the class of persons, if defined by class;
    • A change to the person(s) or accredited organisation undertaking the dealings;
    • Transfer of researcher or person(s) to another organisation;
    • Changes to the certified facilities considered appropriate in which to undertake the dealings, if not defined by a class;
    • Changes to class of certified facilities, if defined by class; or
    • Changes to the dealings (e.g. addition of transport and storage if not previously considered).
    • More information about NLRDs can be obtained from the What are Notifiable Low Risk Dealings (NLRDs)? page on the OGTR website.

    How do I surrender my Accreditation?

    If an accredited organisation no longer requires accreditation, they may apply for a surrender of accreditation. Organisations may wish to seek a surrender of accreditation if, for example, they no longer undertake licenced work with GMOs.
    • Applications for surrender should be made in writing, by an authorised person, to the Regulator. Unless the person submitting the application is listed as an authorised person for this purpose, they will need to state in their application that they are authorised to submit the request on behalf of their organisation. Alternatively, if the person submitting the application is not authorised for this purpose; they can ask a person who is authorised to submit the request.
    • If the organisation has established any IBCs the OGTR should be advised whether or not the IBC/s are being disbanded.
    • The conditions of accreditation continue to apply until the applicant receives written confirmation from the Regulator that the surrender process has been completed.
    • It is a condition of a licence (DIR/DNIR) for an organisation to maintain Accreditation. Holders of accreditation should note that the surrender of accreditation will have implications for any licences which require ongoing accreditation as a condition of the licence
    • Organisations may consider suspending their accreditation (instead of surrendering), if it is clear that it may be needed in the foreseeable future.

    Content within this section