The endorsement of a OECD Test Guideline by the Chemicals and Biotechnology Committee relies on its consensual approval by the Working Party of National Coordinators of the Test Guidelines programme.
Draft Test Guidelines (TGs) and their associated validation reports, and drafts of other OECD documents (e.g draft Guidance Documents (GDs), draft Detailed Review Papers) are submitted by the leading OECD Member country to the OECD Test Guidelines Programme (TGP) secretariat. The latter circulates the drafts to the Working Party of National Coordinators of Test Guidelines programme (WNT) for commenting and approval.
Comments will generally be furnished within 6 to 12 weeks by other National Coordinators (NCs) and other stakeholders, such as the European Commission, BIAC or ICAPO which are consulted by the OECD secretariat. The NCs collect and collate the views of their national experts in the form of a National position paper while views of other stakeholders consulted by the OECD TPG secretariat are compiled in a position paper (See details in OECD GD1 (as revised in 2009)). Draft TGs and other draft documents are also open for public commenting on the OECD website. Public comments are directed to NCs for building National Position Papers.
For each of the commenting rounds, the comments received are addressed by the lead institutions and their NCs in a “response to comments” (RCOM) document. Depending on the extent and nature of comments received on draft documents, the Secretariat, in consultation with the lead Member country, can choose to circulate a revised draft to the NCs together with the RCOM document, or propose to hold an OECD Workshop, a Consultation of Experts, or an Ad Hoc Expert Meeting to resolve outstanding issues. The type of meeting held will depend on the scope and nature of issues identified during the commenting period, and the significance of these issues on the progress and/or finalisation of the TG (OECD GD1, as revised in 2009).
Close collaborations between stakeholders from academia, governmental, industrial and standardisation bodies and others (e.g. non-governmental organisations) are still essential in this phase as comments may either be on a highly scientific level or on regulatory applicability of the method. Furthermore, the methodologies proposed may become more and more complex, challenging the clarity in the TG, which may result in extra rounds of comments. As experts commenting may be new to the project/test method, comments may be going back to basic research science issues that have been discussed already before in the (Ad Hoc) Expert Group. One should be prepared for repeated and/or contradicting comments from one commenting round to the next. Good documentation of meetings/discussions in the (Ad Hoc) Expert Group, as well as detailed responses in the RCOM document developed for each of the commenting rounds, can be used to document (earlier) discussions on a topic (and avoid re-iterations of those discussions). Sometimes one-on-one contact is needed to clarify comments and optimise responses. It is at this phase that the exact wording of the TG/GD is refined based on the comments received.
One should be aware that not all comments need to be accommodated into the TG, but a justification for not taking into account a certain comment and not changing the wording in the TG, for example, is required. In the end, it is a collaborative process between scientists, regulators and industry from the OECD Member countries and countries adhering to the Mutual Acceptance of the Data from all geographical regions in the world, that should aim to find the best compromise.
The pulsed workloads resulting from these commenting rounds may be challenging for individuals of leading institutions to fit the responses in their calendars, especially knowing that a large number of comments are likely to be received. It is also most likely that the permanent staff with more historical implications in the project will reply to comments, with a higher cost per time. It is therefore important to ensure finances or in-kind contributions to cover commenting rounds and the participation of scientists in answering comments. Generally, at least two commenting rounds are required, usually needing a combined duration of 6 months, although the number is not fixed (See timelines section below).
After approval, the WNT’s parental body, the Chemicals and Biotechnology Committee needs to endorse the approval decision before the document can be published in June/July.
Seek financial support to cover staff time for dealing with comments and the revision of the draft TG (or other documents), while extensive resources may be required if further experiments are requested by the Working Party of National Coordinators of the Test Guidelines Programme (WNT).
Send the draft TG and its validation report (or other OECD document) approved by the (Ad Hoc) Expert Group to your National Coordinator (NC) who will contact the OECD Test Guidelines Programme secretariat for its circulation to the WNT.
Be ready to receive (a significant amount of) comments from other NCs and international experts within 6 to 12 weeks after each (re-)submission.
Consider all the comments and find consensus in responses to these comments with the help of the (Ad Hoc) Expert Group associated with the project and with the support of your NC and the OECD secretariat.
To allow approval in April submit the revised TG and the responses to comments to WNT in February (at the latest). For documents that are almost finalised but not totally ready for approval in April, it is also possible that the WNT agrees upon a written final approval procedure during the in-person meeting.
The lead Member country and supporting Project Lead institutions are responsible for replying to comments and finding consensus for the potential divergence. They mobilise the relevant experts, scientists and regulators, part of the project’s Expert Group, to reply to the received comments. Regulators need to ensure that the results from the Test Guideline (TG) or Guidance Document (GD) cover the regulatory needs in their regulatory area.
National Coordinators (NCs) have all the institutional memory and provide the last layer of comments regarding the science and policy implications of the test method. They mobilise the expertise of various national stakeholders of their network and summarise the comments received in a national position paper. When meeting in the context of the Working Party of National Coordinators of the Test Guidelines Programme, NCs will then discuss and approve (or not) the revised OECD document(s).
The OECD Secretariat of the Test Guidelines Programme re-circulate received comments to the NCs and summarises the comments received from other international stakeholders (e.g. Standardisation networks, NGOs) in position papers. The Secretariat also provides support to the lead country and lead institutions to find consensus on conflicting points and important issues refraining from progress in the document by organising (Ad Hoc) expert meetings or dedicated workshops, as examples.
In the end, it is a collaborative process between experts from standardisation, academia, industry, and governmental or non-governmental institutions from all geographical regions in the world that should aim to find the best compromise.
Ensure broad support of the draft document by the (Ad Hoc) Expert Group before submission to the Working Group of National Coordinators of the Test Guidelines Programme (WNT) for commenting.
Be prepared to be surprised by unexpected comments and plan for sufficient time to consult (international) experts and to reply to comments.
Make yourself familiar with OECD Test Guideline wording, if not already done, as the glossary will be fine-tuned during the commenting phase to make sure that there are no contradictory concepts and terminology with existing OECD documents. Indeed, terms have different scientific, regulatory and legal areas and need to be well selected.
Use results from (Ad Hoc) Expert Group discussions, the validation report (in the case of a TG), and previous ‘response to comments’ documents (if any) to answer comments.
Seek one-on-one contact to clarify difficult comments with the help of the OECD secretariat and your National Coordinator
Ensure financial support to cover the commenting rounds and the participation of scientists and regulators in answering comments.
Document approval generally occurs once a year in the annual meeting of the Working Group of National Coordinators of the Test Guidelines Programme (WNT), at OECD in April. For documents that are almost finalised but not totally ready for approval in April, it is also possible that the WNT agrees upon a written final approval procedure during the in-person meeting.
To accommodate sufficient time the initial commenting on the draft Test Guideline (TG) should best start in June, generally followed by submission of the final TG to WNT in February after typically two commenting rounds.
After approval, the WNT’s parental body, the Chemicals and Biotechnology Committee needs to endorse the decision before the document can be published in June/July.
A better understanding of the OECD Test Guidelines Programme and the validation principles in action
OECD GD1. Guidance Document for the Development of OECD Guidelines for the Testing of Chemicals (as revised in 2009)
Draft documents available for public commenting
Chemicals and Biotechnology Committee