Project definition at OECD

During the project definition phase at OECD, the evaluation of the maturity of the selected methodologies is conducted, and the scope of the OECD project is defined based on the regulatory needs screened at the previous phase (See Pre-OECD phase). The overall result is the completion of a Standard Project Submission Form (SPSF), submission (deadline 15th November) and its agreement by the Working Party of National Coordinators of the OECD Test Guidelines Programme (WNT) at the annual meeting in April. The SPSF describes the project, the methodologies and its scope (i.e. purpose, use and limitations). The foreseen timelines and resources needed for the project have also to be included in the SPSF (OECD GD1, 2009).

New proposals are brought to the WNT under the form of an SPSF by a lead OECD Member country (MC) supported by leading research institutions and/or research projects. National Coordinators (NCs) are indeed in contact with regulators, standardisation bodies, and other research institutes, networks and initiatives. International expert consultations and financial support can also be organised via research projects (e.g. NanoHarmony) where a broad community of scientists from different backgrounds can provide feedback and resources for the development of the document to ensure the submitted SPSF is more acceptable in the OECD Test Guidelines Programme (TGP), with, time and resource needs appropriately defined. Please consult the dedicated process page on drafting an SPSF within this tool for further details on the requested information in the SPSF. In parallel, discussion with your NC and its network (initiated during the pre-OECD phase) should help you review whether the foreseen output of the potential project will become relevant for only one or more MCs, whether the proposed TG will be broadly applicable or just for one class of chemicals or one chemical sector, what are the means to ensure broad availability of methods and equipment across MCs for example (See Regulatory needs).

It is also important to screen with your NC and/or with the OECD secretariat if it's of the interest of your project to consult other OECD Working parties or the WNT prior to a formal SPSF submission which has to be done by the respective NC. For example, for projects with a focus on nanomaterials, the submission of a project proposal to the OECD Working Party on Manufactured Nanomaterials (WPMN) (and/or any relevant Working Party for the project) prior to the submission of an SPSF to WNT is highly recommended. The WPMN can provide support and expertise for the project proposal to be further detailed and structured, in the case methodologies and/or the scope need to be further defined, for example. Contact with relevant OECD Working Parties through your NC or the OECD secretariat will ensure good coverage of the expertise in the topic and TG development (e.g. Joint WPMN/WNT expert groups).In the SPSF template, questions relative to the validation status of the selected method(s) will help you prepare for the next phase of the project i.e. the development phase at OECD and will ensure that you appreciate the resources (staff time and cost) required to validate the selected methods or guidance. It is therefore highly recommended at this stage to consult validation requirements expressed in OECD GD34 (2005) and the validation process page of this tool.

The pre-OECD phase involves activities prior to the development and submission of formal project proposals to WPMN or WNT. It is the phase during which ideas for potential projects are explored and only those ideas considered worthy of further consideration are expanded and developed for eventual formal consideration by OECD committees. Many initial ideas or suggestions explored in this phase may be rejected for a variety of reasons.

The assessment, review and interpretation of the data available is a key step to identify the data gaps and current state of the art. It determines whether a new TG needs to be developed or an already available TG can be adapted. The readiness of a test method with regard to its relevance and robustness influences the time required to go through the OECD process. Furthermore, the adequate selection of the type of OECD documents that the project targets to produce is important. There are different outputs for a contribution to the OECD TGP: Test Guidelines (TGs) (new, updated, corrected, deleted) covered by the Mutual Acceptance of Data (MAD) principle and other documents, not covered by the MAD principle. Other documents include Guidance Documents (GDs) to support the adequate conduct of TG studies and provide harmonisation in necessary flexibility or possible adaptations, validation and peer-review reports to establish the foundation of new methods, and detailed review papers to explore a new area of testing. Consult the NanoHarmony Training Material - From science to standards and harmonised OECD Test Guidelines to learn more about the different OECD documents.

Extracted from the NanoHarmony Training
‘The different OECD documents in the OECD Test Guidelines Programme’

Other than helping you define your initial scope, the review of the available data should also support the identification of the essential measurands and data gap-filling experiments required to translate a complex comprehensive science into harmonised methods and/or guidance that are actually doable, reproducible and fit for purpose. Indeed, one of the major challenges faced during an OECD TG/GD development is to find a balance between simplification and realism to maintain the relevance of the foreseen TG or GD (See Development phase at OECD).

Proposals for the development of new or updated TGs can be submitted by the MCs, the international scientific community, industry, and non-governmental organisations, all via a National Coordinator. They can also be submitted by the European Commission or the Secretariat (OECD GD1, 2009). Take note of deadlines for the submission of SPSF for WNT as it only meets once a year. The deadline for the submission of the SPSFs by the respective NC to the OECD secretariat will be the 15th of November for it to be decided on in April of next year. To allow the drafting of a comprehensive SPSF, the respective NC should be contacted sufficiently in advance (see Timelines section below).

Each year, there are between 10 and 25 SPSFs that are submitted for evaluation to the WNT, so the acceptance of a project not only depends on the relevance of the methodology, its predictive capacity and its reproducibility but also on the balance between capacities of the different expert groups and the regulatory requirements. After submission, the SPSF will be commented on by other NCs and their corresponding national networks and experts consulted by the OECD secretariat in mid-January of the next year at the latest. The leads then have to prepare responses to the comments and revise the SPSF as appropriate. Again take note of the deadline for the submission of the reply to comments and/or of the updated SPSF, as you will dispose of only a few (six) weeks if you intend to move your project toward the development phase in the next WNT meeting (see timelines section).

Revised SPSFs and RCOM are discussed at the annual WNT meeting in April. A project is considered for inclusion in the work plan of the OECD TGP when the NCs agree that the SPSF is sufficiently clear and complete to demonstrate that the foreseen project’s outputs will provide sufficient added value to risk assessment. See details in OECD GD1. Guidance Document for the Development of OECD Guidelines for the Testing of Chemicals (as revised in 2009). Once approved by all OECD Member countries (consensus) at WNT, the project will become part of the work plan of the OECD TGP. This is the phase where the project is officially started at OECD. If requested in the project SPSF, the OECD secretariat will reach out to OECD Member countries and countries adhering to the Mutual Acceptance of Data to nominate national experts to be part of an (Ad Hoc) expert group that supports the project. Experts may also be nominated through the networks of other key stakeholders of the OECD TGP such as BIAC and ICAPO. Alternatively, a project can be attributed to one of the standing expert groups. The (Ad Hoc) expert group provides advice on scientific and technical aspects and broader issues, including regulatory, related to the project and supports the development of TG/GD drafts prior to wider circulation, typically by providing comments (See OECD expert groups & Development at OECD).

• Seek (long-term) financial support and personal capacity to support the expenses and time required for discussions at the relevant OECD Working Parties and for any pre-validation work required at this stage in reply to comments furnished by the experts of the OECD Test Guidelines Programme on the project proposal. See the financial support process page of this tool for further details.

• Seek the support of your National Coordinator and the OECD Secretariat in facilitating discussions with relevant OECD stakeholders and their networks. They will also provide support to select the most appropriate OECD document to target for the project in order to tackle the regulatory and scientific challenges and needs.

• Identify and collate relevant data, test methods and Standard Operating Procedures (SOPs) and publish the output of such work to cement your project with peer-reviewed publications, identify additional gap-filling experiments and continue the effort initiated during the pre-OECD phase to increase the awareness of the research community about the project.  

• Fill the SPSF template with the support of your National Coordinator and (potentially) other members of your team leading the project proposal (e.g. National delegates of other OECD Working Parties, scientific experts developing the test method, partners from co-leading Member countries). Please refer to the Draft an SPSF page of this tool for further details on the information needed in the SPSF.

• Once the proposal meets the needs of the WNT (based on the information needs described in the SPSF), a formal submission of the SPSF is made by the proposing Member country, the European Commission or the OECD Secretariat for consideration by the WNT meeting.

• Reply to all comments received on the SPSF  and find consensus with the support of your NC and the co-leaders of the project (leading Member country and leading institutions).

• If the WNT finds the proposal suitable, the project can be added to the work plan of the OECD Test Guidelines Programme.

The role of your National Coordinator (NC) for contact with other NCs becomes more important in this phase as the required project proposal (in the form of a Standard Project Submission Form or SPSF) will be submitted on behalf of the leading OECD Member country (MC). Your NC will help you to appropriately draft the SPSF and guide you through the review process of the Working Party of National Coordinators of the Test Guidelines programme (WNT) and to respond to the comments from the various OECD MCs and other stakeholders. 

OECD Secretariat can support here in communication and on several other aspects, e.g. contact with national delegates of the Working Party on Manufactured Nanomaterials or other relevant working parties of the Chemicals and Biotechnology Committee (CBC), compiling an action plan and timelines, organise meetings, identifying issues (e.g. protected elements of a method, whether the method should replace an existing TG or not), and clarify the deadlines. The Secretariat of the OECD Test Guidelines Programme (TGP) is also in charge of circulating the SPSFs to the WNT and collecting national feedback from the OECD MCs and countries adhering to the Mutual Acceptance of Data, and from the wider stakeholder groups involved in the TGP, including the Business and Industry Advisory Committee to the OECD (BIAC), the International Council on Animal Protection in OECD Programmes (ICAPO), international scientific societies and/or other recognised organisations and NGOs, as appropriate.

In general, consultation and communication with academics, governmental, industrial and standardisation bodies and their networks is highly recommended at the early stages of an OECD project (See Pre-OECD phase). Individuals and representatives of such institutions will help you to define the adequate level of simplification and realism for your project and thus maintain its relevance. Interested individuals could then be more formally involved in developments, discussions, and adaptation processes of the project later on, if nominated to be part of its Ad Hoc expert group or if interested in being part of the validation process, for example.

• Knowledge about the OECD process is key. The Working Party of National Coordinators of the OECD Test Guidelines Programme (WNT) meets only once a year in April and the deadline for the submission of a Standard Project Submission Form (SPSF) by the respective National Coordinator (NC) to the secretariat is the 15th  of November. You should get in contact with your NC sufficiently in advance to make her/him aware of your intention and to prepare a comprehensive SPSF in due time.  However, if you intend to submit a project to the OECD Test Guidelines Programme, you can contact your NC at any period of time to discuss your idea (See Pre-OECD phase). You will receive comments from the WNT in January next year (at the latest), and you will dispose of a short period of time (i.e. 6 weeks) to reply to the received comments so that the responses and the revised SPSF can be discussed and the project proposal evaluated at the next WNT meeting in April.

• Ensure good communication with the WNT and other Chemicals and Biotechnology Committee Working Parties through your NC. NCs have an overarching view on existing Test Guidelines and ongoing projects that might impact the proposal. They can exchange with the other NCs (and their respective networks) to confirm the regulatory needs facilitate consistency and avoid conflicting results. This helps anticipate NC comments in the later stages of the project.

• Ensure the latest version of the SPSF template is used to provide good responses to the requested information; look for it on the OECD Test Guidelines Programme website. As further on in the process, already in this phase, the challenge is to be precise and provide a common understanding while ensuring that the test method to be developed can facilitate the risk assessment in each of the OECD Member countries. Already in the SPSF focus of the project should be clear, e.g. details of envisioned revisions for an existing TG/GD. This will prevent unnecessary re-iterations of earlier discussions. 

• Some cases may benefit from keeping the project at a level of a dedicated Working Party (e.g. WPMN) or a WNT-related expert group first, to smooth out a project in a less official setting where more technical and regulatory expertise is available. The Working Party will provide support for the project to be further detailed, structured and aligned with ongoing OECD projects. Additional expertise may be sought in the scientific community and their networks, or with stakeholders that will become (potential) users of the TGs/GDs. At WPMN an Ad Hoc expert group is not essential, but the early establishment of an expert network is beneficial in scoping the project and may facilitate the formation of the (Ad Hoc) expert group once the SPSF is accepted in the Work Plan of the OECD Test Guidelines Programme (TGP).

• Publish in peer-reviewed journals the critical analysis of the state-of-the-art and the identification of relevant data gaps that result from the collation of data, test methods and Standard Operating Procedures (SOPs) work. A detailed review paper could also be a project on the OECD TGP work plan.

• Regarding the WNT commenting of the SPSF, sometimes you can receive a large number of comments., You should reply to all but not all of them have to be agreed upon. Still, adequate arguments need to be given, in case a comment is disagreed or excluded. If no consensus is reached on a particular point, sometimes it may be better to take the point out if not key. The consultative process described above (using workshops, conferences, and expert meetings) can be used to respond to comments received on the proposal if there are outstanding issues.

Official submission of an SPSF is done by the National Coordinators, the European Commission or the OECD secretariat at or before the yearly deadline of 15th of November. Submission of the final version of the Standard Project Submission Form (SPSF) to your National Coordinator (NC) should therefore be at the latest on the 1st of November (while prior contact with your NC is needed well before that date to ensure your NC is aware of your plans).

After submission, other NCs within WNT may provide comments on the SPSF (until mid-January), which need to be addressed before the WNT meeting (by end-February/beginning of March) in a response document and/or a re-submitted version of the SPSF.

In the yearly WNT meeting in April,  SPSFs are discussed and may be approved, resulting in the project entering the Work plan of the OECD Test Guidelines Programme. 

The OECD secretariat will then contact NCs and other key stakeholders of the OECD Test Guidelines Programme (e.g. BIAC, ICAPO) to identify (national) experts willing to integrate the (Ad Hoc) expert group of the project if requested. The timeline associated with the formation of the Ad Hoc expert group depends on the pre-existence of informal expert networks (e.g. formed in the context of an EU Project for example) or the adequation of existing expert groups that oversee projects falling into particular categories (e.g. Ecotoxicity and Fate of Nanomaterials), but generally, a tailored expert group for support of a specific project may take up to a couple of months to be formed.