Notifiable low risk dealing (NLRD)

Which dealings are NLRDs?

Schedule 3 of the Regulations describes the types of dealings with GMOs that are classified as NLRDs and outlines the NLRDs suitable for at least physical containment level 1 and the NLRDs suitable for at least physical containment level 2.

These parts also refer to the host/vector systems described in Part 2 of Schedule 2 (host/vector systems for exempt dealings).

Application process and forms

If the GMO work that you intend to undertake is an NLRD then you need to register it with the IBC. The IBC will assess and endeavour to process the registration within four weeks (investigators should allow for this when determining their proposed commencement date). You will be advised in writing of the outcomes of the assessment.

The IBC GMO Dealing Application form is used to register both exempt dealings and NLRDs. If your work involves both kinds of dealings you can now include details of all work for the one project on the one form.

You must not commence the work until you have received written confirmation from the IBC that you are authorised to do so.

IBCs are no longer required to notify the OGTR of each new NLRD, but instead must report them once a year via the organisation's annual report. This means that the Identifier allocated to your NLRD (which was previously issued by the OGTR) will be generated by the IBC upon approval of the dealing.

If your dealing involves an AQIS Import Permit for the import of GMOs then you should ensure that the IBC is aware of the proposed import and is kept up-to-date of all details of GMOs for the dealing. This is because AQIS contacts the OGTR to confirm that any GMOs you intend to import are appropriately authorised before an import permit is issued; however, as IBC's only need to report about NLRDs once a year, this often leads to problems accessing the relevant information and results in delays in obtaining import permits.

The OGTR also requires that GMOs authorised under an NLRD that are stored outside of a certified PC2 facility are authorised by the IBC. Unauthorised storage of GMOs is an offence under the Act. Investigators should also ensure that all proposed transport, including importation or exportation, of GMOs is included in the dealing as these aspects of a dealing also require approval.

The OGTR has issued a series of documents to assist those investigators working with defective viral vectors to determine which category of dealing their work falls into:

• Guidance flowchart for the classification of contained dealings with viral vectors
• Guidance tables on the changes to the classification of contained dealings with viral vectors resulting from the implementation of the Gene Technology Amendment Regulations 2011 (No. 1)
• Guidance tables for the classification of contained dealings with viral vectors

Conditions and responsibilities

• work must not involve an intentional release of the GMO into the environment – any unintentional release of GMOs must be reported to the IBC immediately;
• NLRDs must be conducted within a contained facility certified to at least the correct PC level for the dealing and of appropriate design for containing the type of GMO;
• any transport of GMOs must be conducted in accordance with the OGTR Guidelines for the Transport of GMOs;
• all personnel must undertake appropriate training before commencing the work and safe working procedures must be understood and enforced;
• the IBC is notified as soon as possible of any changes to the work registered as an exempt dealing;
• if work on an NLRD ceases or never commences you must advise the IBC accordingly;
• stored GMOs must be authorised.