Almost all OECD projects approved by the Working Group of the National Coordinators of the Test Guidelines Programme (WNT) that are related to the development of Test Guidelines (TGs) and/or Guidance Documents (GDs) have an associated official OECD Expert Group, typically referred to as an Ad Hoc Expert Group. This Ad Hoc Expert Group is established for a specific project using a standard approach by OECD secretariat. For WNT, the Secretariat contacts all the National Coordinators (NCs) requesting Member Countries (MCs) to nominate national experts to join the Expert Group while international organisations such as BIAC, ICAPO or non-governmental organisations are directly invited to nominate experts.
Working parties of the Chemicals and Biotechnology Committee (CBC), such as the WNT and the Working Party on Manufactured Nanomaterials (WPMN) also have more general standing Expert Groups that focus on particular areas and groups of projects (e.g. the WPMN Steering Group on Testing and Assessment (SGTA).
It is also possible to use these existing expert groups to support the development of a relevant TG/GD project. Advice on which standing Expert Groups may be relevant to a specific project can be sought from the OECD Test Guidelines Programme (TGP) secretariat.
The number and focus of the standing Expert Groups associated with WNT and other Working parties (WPs) of the CBC of relevance to the OECD TGP is not fixed in the long term. New expert groups can be created to focus on new areas of interest and other Expert Groups closed when they are no longer needed (i.e. Expert Groups are active as long as there is a project relevant to this area in the OECD TGP work plan). Here we focus on the main current active expert groups (to date), others potentially of interest may also exist or plans may be in place to create them, guidance on this can be sought from NCs and the OECD TGP secretariat.
- WNT standing Expert Groups; Genotoxicity testing, Skin/eye irritation/phototoxicity, Skin sensitisation, Non-genotoxic carcinogenicity, Developmental neurotoxicity, Immunotoxicity, Ecotoxicity testing in aquatic/sediment environment.
- Other standing Expert Groups of other WPs of the CBC such as the SGTA for the WPMN.
- Joint WPs-WNT Expert Groups such as the Expert Groups on Physico-chemical properties of nanomaterials, Ecotoxicity and environmental fate of nanomaterials, Nanoparticles in biological samples, Nanomaterials’ intestinal fate for the Joint WPMN-WNT expert groups.
You can consult the publications from the WPs of interest to know more about the active standing Experts Groups (e.g. Publications in the Series on the Safety of Manufactured Nanomaterials - OECD) and the current Work Plan of the OECD TGP. It is also possible that other groups of experts will be associated with the scientific development supporting an OECD project. For example, funding to support scientific development may be provided by another organisation (e.g. EU) and as part of this work, a group of experts in the area may be formed to provide advice and support. National groups of relevant stakeholders may also be formed to support the project including financially. All such groups and wider networks can be very useful for the development and ultimate publication of an OECD TG/GD and consideration should be given to such groups, but they should not be confused with the official OECD Expert Groups.
The Ad Hoc Expert Group provides support to the project lead institution(s). The group members provide advice on scientific and technical aspects and broader issues, including regulatory, related to the project and support the development of TG/GDdrafts prior to wider circulation, typically by providing comments. Other WNT and WPMN standing Expert Groups may also provide useful input and advice, especially on the relationship with other related projects.
Forming and then engaging appropriately with the Ad Hoc Expert Group and other OECD standing Expert Groups is a very effective approach to gaining useful expert advice, and input to document drafting and, importantly, help identify key problems at an early stage to ease the overall TG/GD development and acceptance process.
If your project is proposing minor changes to existing TG/GDs then it may not be necessary to interact with an Ad Hoc Expert Group, relying instead on WNT and other WP members directly or standing Expert Groups to provide input. However, this should be discussed with the Secretariat. Progressing to WNT is a good time to discuss with the OECD TGP Secretariat whether new members are required and whether engagement with WNT would be improved by a further request for members from NCs.
For a new TG/GD-related project introduced at WNT or at other WPs (beforehand if deemed relevant), rather than forming an Expert Group specific to the project an alternative is to use one of the standing Expert Groups, e.g. the SGTA for the WPMN, to present the project to and provide draft SPSFs for comment before advancing to project development phase at OECD. Whether the use of this group or a project-specific group would be best for a specific project can usefully be discussed with the Secretariat of the OECD TGP and the Chair of the relevant standing Expert Group.
The OECD Secretariat will typically ask if you want to establish an Ad Hoc Expert Group or to add expertise to an already existing Expert Group (e.g. WNT standing Expert Groups as described in the description section) in early discussions about your project. Under almost all circumstances the answer should be yes. Be aware that this process does not guarantee that you will achieve the range of expertise in the (Ad Hoc) Expert Group that you might feel you require, but there is some flexibility.
The composition of the (Ad Hoc) Expert Group should reflect the breadth of the project. If you are particularly interested in having input from experts in specific areas related to a project, perhaps to cover potential areas of weakness in the project team, then tell the OECD Secretariat and they can include details in the call for Experts.
If after the (Ad Hoc) Expert Group has been established you want to include more experts then the Secretariat can ask again for further members, so the initial group is not ‘set in stone’. If there are specific individual experts that you would like to be involved with, then it is acceptable to discuss this with them informally and explore whether they can be nominated by their National Coordinator (NC), but the final decision remains with the NCs. This is generally easier to address if the experts are from the Member country of the Project Lead.
If there are any issues with the Expert Group, then these should always be discussed with the OECD Secretariat.
Engagement with the (Ad Hoc) Expert Group is primarily through meetings. Nowadays these are typically online, which aids the the involvement of experts from a wide range of Member countries.
The frequency of meetings varies according to the type of project and the stage it has reached. Generally, there will be an initial kick-off meeting at which the project, including the technical plan and timeline, is presented to the (Ad Hoc) Expert Group, providing an important opportunity for any potentially problematic issues to be raised at an early stage.
A typical pattern in the early stages of a project is for this to be followed by regular meetings (at least 6-monthly to 1-yearly) allowing the Project Lead(s) to present progress to the (Ad Hoc) Expert Group.
During later stages of the project when the TG and/or GD are being drafted communication will typically involve circulating a draft to the members, collating comments received (typically undertaken by the Secretariat) providing a written response to comments and producing an updated draft. When comments are minor email correspondence is sufficient but for major changes and significant comments, the usual practice is to hold a meeting to go through responses to comments and the revised draft to see how the comments have been addressed.
Discuss meeting timing with the Secretariat who will arrange the meetings. Be aware that they prefer to give reasonable notice of meetings especially if documents for discussion are circulated beforehand. It is good practice to plan meetings well in advance.