Exempt dealings are dealings described in Schedule 2 of the Gene Technology Regulations 2001 (the Regulations).
Part 1 of Schedule 2 describes the type of dealings which are classified as exempt whilst Part 2 of Schedule 2 outlines the host/vector systems. Note that, these host/vector systems are also relevant to the classification of Notifiable Low Risk Dealings (NLRDs) and Dealings not involving Intentional Release (DNIR) in Schedule 3 of the Regulations.
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
The only further legislative requirements for exempt dealings is that they do not involve an intentional release of the GMOs into the environment, or a retroviral vector that is able to transduce human cells.
If the GMO work that you intend to undertake is exempt then you need to register it with the IBC. Your registration will be assessed by the IBC and the exempt status of your registration will be confirmed to you in writing.
The IBC GMO Dealing Application form is used to register both exempt dealings and notifiable low risk dealings. 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.
The OGTR has released Guidance Notes for the Containment of Exempt Dealings, which are for guidance only to persons conducting exempt dealings. They may be of assistance in determining how to undertake exempt dealings with regard to avoiding intentional release.
Investigators are responsible for ensuring that:
- work with an exempt dealing must not involve an intentional release of the GMO into the environment – any unintentional release of GMOs must be reported to the IBC immediately;
- the IBC is notified as soon as possible of any changes to the work registered as an exempt dealing;
- the IBC is notified if work on the exempt dealing ceases or never commences;
- stored GMOs are authorised.