OECD Test Guidelines are broadly accepted both by the international scientific community and by appropriate regulatory authorities of OECD Member countries because they are based on the opinion of recognised experts and authorities consulted at various stages of their development.
The leading country can also seek informal comments from a subgroup of NCs of the WNT, prior to a formal submission of SPSFs to WNT (OECD GD1 as revised in 2009). But once circulated to the WNT, NCs of the WNT and other stakeholders of the OECD Test Guidelines Programmes, such as BIAC or ICAPO, are invited to formally evaluate the project, taking into account the priority of the project compared to the capacity of the various OECD Expert groups (e.g. regulatory need of one of several member countries), but also the validation status of the selected test method(s), and the adequation of the transparency level foreseen regarding for the elements that are protected by intellectual property rights (Intellectual Property elements in OECD Test Guidelines - OECD) (See Draft SPSF).
Between February and April (i.e. prior WNT Meeting), each NC and the EC should provide a rationale for their position on each proposal to develop a new or update an existing, Test Guideline or Test Guideline related document. Generally, the project proposal will be presented at the WNT meeting by the NC of the leading Member country, and a decision of the WNT to i) include the project on the work plan of the OECD Test Guidelines Programme (TGP), or ii) request that additional information or clarification be provided and conditionally include the project on the work plan, or iii) decline the project proposed in the SPSF, is emitted during the meeting (OECD GD1, revised in 2009).
During the WNT meeting, drafts of TGs and other related documents (e.g. Guidance Document, Detailed Review paper) are also evaluated for approval. To assist in reaching an agreement on these drafts, NCs should prepare a National Position Paper on each document circulated for review and commenting. The National Position Paper should preferably contain a national view on each issue raised in the document under review, but could also be a compilation of alternative views when no scientific agreement on certain issues was possible within a Member country. In order to allow the views of individual experts to be seen by the WNT, NCs should attach comments to the National Position Paper, either in their original form or as summarised by the NC. The professional affiliation of the consulted experts may be indicated so that the Secretariat and other Member countries can obtain an insight into how broadly the scientific and regulatory community has been consulted OECD GD1 (as revised in 2009).
NCs and representative bodies generally have 6 to 12 weeks to consult the views of their national experts and members. During the same period, drafts are also made available on the OECD website for public commenting. Public comments are directed to the relevant NC to complement the National Position Paper which compiles the received comments per Member country. Other stakeholders’ views are compiled by the OECD TGP secretariat in the form of position papers. National position papers and position papers are then transferred back to the NC of the Leaning Member country by the OECD TGP secretariat which collates all submitted comments in one document (See details in OECD GD1 (as revised in 2009)). Such collections can sometimes include hundreds of individual smaller and bigger comments for a single document.
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. One should be aware that not all comments need to be accommodated into the document, but a justification clarification for not taking into account a certain comment is required. Depending on the extent and nature of comments received on draft documents circulated to the NCs and other stakeholders, 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 held 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 document under evaluation (OECD GD1, as revised in 2009).
As explained in the timeline section of the commenting and approval phase at OECD, the refinement of OECD draft documents generally takes 2 commenting rounds. But depending on the complexity of the methods or test strategies under standardisation and harmonisation as well as the complexity of the regulatory area that they relate to, it is possible that more commenting rounds are required to refine the document up to approval by consensus (i.e agreement of all the OECD Member countries, if approval there is). To reduce the number of commenting rounds, a process page dedicated to the drafting of OECD documents can be consulted within this tool. The latter summarises the content that should be developed in different types of OECD documents (e.g. TG or GD) and the factors that should be taken into account to smooth the commenting phase (e.g. the methodologies proposed should be simple for the TG to be as clear as possible).
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. Indeed, comments on initial drafts take place in (Ad Hoc) Expert Groups and focus mainly on technical and scientific aspects of the method developed. Towards finalisation of the document (i.e. after formal submission to the WNT), WNT commenting rounds will take place where National Coordinators (NCs) or other stakeholders may see the documents for the first time and political and/or regulatory comments may be brought in. 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.
TIPS and TRICKS
Ensure that each comment received is addressed in a “response to comments” (RCOM) document for each of the commenting rounds. These can be used to document (earlier) discussions on a topic (and avoid re-iterations of those discussions). Take every comment seriously and provide a clear and comprehensive explanation of how the comment has been taken into account (or not).
In some cases, one-on-one discussions with a commenter may help to better understand a comment and to allow a better response.
National Coordinators (NCs) have usually seen different RCOM documents for a range of different Test Guidelines and Guidance Documents/GDs. These experiences can help in providing responses.
Be aware that all NCs will see your responses and might pick up comments from other NCs in a subsequent commenting round if the response is not satisfactory.
One should be prepared for repeated and/or contradicting comments from one commenting round to the next (e.g. increase relevance but reduce cost). 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 or comments can appear from an OECD Member country after several commenting rounds.
The pulsed workloads resulting from these commenting rounds may be challenging, especially knowing that a large number of pages of comments are likely to be received. It is therefore important to ensure finances or in-kind contributions to cover commenting rounds and the participation of scientists in answering comments.
Timelines
Timelines depend on the progress of the document/process.
Towards the finalisation usually, two open consultation/commenting rounds are needed on the document, which generally requires 6-8 months towards the Working Party of National Coordinators of the Test Guidelines Programme (WNT) meeting in April. Documents are generally open for 6-12 weeks to allow commenting. As hundreds of comments may come in, an equal amount of time is easily needed to address them all in the document and/or a response to the comments document.
Commenting aspects
OECD Test Guidelines are broadly accepted both by the international scientific community and by appropriate regulatory authorities of OECD Member countries because they are based on the opinion of recognised experts and authorities consulted at various stages of their development.
Extracted from the NanoHarmony Training Material – From science to standards and harmonised OECD Test Guidelines
‘The process of development of OECD documents’
During the Project Definition phase at OECD, a Standard Project Submission Form (SPSF) must be used to propose the deletion, the development of a new or a revision of an existing Test Guideline (TG) to the Working Group of National Coordinators of the TGs programme (WNT). An SPSF is also required to develop a Guidance document (GD), a Detailed Review Paper or any documents considered sufficiently important by the WNT or the OECD TGs Programme (See Draft SPSF). SPSFs are formally submitted on the 15th of November by the National Coordinator (NC) of the leading Member country, the European Commission or the OECD secretariat (See Project definition phase at OECD).
The leading country can also seek informal comments from a subgroup of NCs of the WNT, prior to a formal submission of SPSFs to WNT (OECD GD1 as revised in 2009). But once circulated to the WNT, NCs of the WNT and other stakeholders of the OECD Test Guidelines Programmes, such as BIAC or ICAPO, are invited to formally evaluate the project, taking into account the priority of the project compared to the capacity of the various OECD Expert groups (e.g. regulatory need of one of several member countries), but also the validation status of the selected test method(s), and the adequation of the transparency level foreseen regarding for the elements that are protected by intellectual property rights (Intellectual Property elements in OECD Test Guidelines - OECD) (See Draft SPSF).
Between February and April (i.e. prior WNT Meeting), each NC and the EC should provide a rationale for their position on each proposal to develop a new or update an existing, Test Guideline or Test Guideline related document. Generally, the project proposal will be presented at the WNT meeting by the NC of the leading Member country, and a decision of the WNT to i) include the project on the work plan of the OECD Test Guidelines Programme (TGP), or ii) request that additional information or clarification be provided and conditionally include the project on the work plan, or iii) decline the project proposed in the SPSF, is emitted during the meeting (OECD GD1, revised in 2009).
During the WNT meeting, drafts of TGs and other related documents (e.g. Guidance Document, Detailed Review paper) are also evaluated for approval. To assist in reaching an agreement on these drafts, NCs should prepare a National Position Paper on each document circulated for review and commenting. The National Position Paper should preferably contain a national view on each issue raised in the document under review, but could also be a compilation of alternative views when no scientific agreement on certain issues was possible within a Member country. In order to allow the views of individual experts to be seen by the WNT, NCs should attach comments to the National Position Paper, either in their original form or as summarised by the NC. The professional affiliation of the consulted experts may be indicated so that the Secretariat and other Member countries can obtain an insight into how broadly the scientific and regulatory community has been consulted OECD GD1 (as revised in 2009).
NCs and representative bodies generally have 6 to 12 weeks to consult the views of their national experts and members. During the same period, drafts are also made available on the OECD website for public commenting. Public comments are directed to the relevant NC to complement the National Position Paper which compiles the received comments per Member country. Other stakeholders’ views are compiled by the OECD TGP secretariat in the form of position papers. National position papers and position papers are then transferred back to the NC of the Leaning Member country by the OECD TGP secretariat which collates all submitted comments in one document (See details in OECD GD1 (as revised in 2009)). Such collections can sometimes include hundreds of individual smaller and bigger comments for a single document.
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. One should be aware that not all comments need to be accommodated into the document, but a justification clarification for not taking into account a certain comment is required. Depending on the extent and nature of comments received on draft documents circulated to the NCs and other stakeholders, 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 held 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 document under evaluation (OECD GD1, as revised in 2009).
As explained in the timeline section of the commenting and approval phase at OECD, the refinement of OECD draft documents generally takes 2 commenting rounds. But depending on the complexity of the methods or test strategies under standardisation and harmonisation as well as the complexity of the regulatory area that they relate to, it is possible that more commenting rounds are required to refine the document up to approval by consensus (i.e agreement of all the OECD Member countries, if approval there is). To reduce the number of commenting rounds, a process page dedicated to the drafting of OECD documents can be consulted within this tool. The latter summarises the content that should be developed in different types of OECD documents (e.g. TG or GD) and the factors that should be taken into account to smooth the commenting phase (e.g. the methodologies proposed should be simple for the TG to be as clear as possible).
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. Indeed, comments on initial drafts take place in (Ad Hoc) Expert Groups and focus mainly on technical and scientific aspects of the method developed. Towards finalisation of the document (i.e. after formal submission to the WNT), WNT commenting rounds will take place where National Coordinators (NCs) or other stakeholders may see the documents for the first time and political and/or regulatory comments may be brought in. 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.
Ensure that each comment received is addressed in a “response to comments” (RCOM) document for each of the commenting rounds. These can be used to document (earlier) discussions on a topic (and avoid re-iterations of those discussions). Take every comment seriously and provide a clear and comprehensive explanation of how the comment has been taken into account (or not).
In some cases, one-on-one discussions with a commenter may help to better understand a comment and to allow a better response.
National Coordinators (NCs) have usually seen different RCOM documents for a range of different Test Guidelines and Guidance Documents/GDs. These experiences can help in providing responses.
Be aware that all NCs will see your responses and might pick up comments from other NCs in a subsequent commenting round if the response is not satisfactory.
One should be prepared for repeated and/or contradicting comments from one commenting round to the next (e.g. increase relevance but reduce cost). 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 or comments can appear from an OECD Member country after several commenting rounds.
The pulsed workloads resulting from these commenting rounds may be challenging, especially knowing that a large number of pages of comments are likely to be received. It is therefore important to ensure finances or in-kind contributions to cover commenting rounds and the participation of scientists in answering comments.
Timelines depend on the progress of the document/process.
Towards the finalisation usually, two open consultation/commenting rounds are needed on the document, which generally requires 6-8 months towards the Working Party of National Coordinators of the Test Guidelines Programme (WNT) meeting in April. Documents are generally open for 6-12 weeks to allow commenting. As hundreds of comments may come in, an equal amount of time is easily needed to address them all in the document and/or a response to the comments document.
Read more
OECD GD1. Guidance document for the Development of OECD Guidelines for the Testing of Chemicals (as revised in 2009)
Draft test guidelines for public comments
Draft guidance and review documents for public comments