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) or a Detailed Review Paper or related documents ( See the NanoHarmony Training Material - From science to standards and harmonised OECD Test Guidelines to learn more about the different OECD documents). SPSFs are formally submitted by the National Coordinator (NC) of a leading Member country, the European Commission or the OECD secretariat prior to the WNT meeting (OECD GD1, revised in 2009).
An SPSF template is available on the website of the OECD Test Guidelines Programme (TGP). The form specifies the project description and the actions planned toward the development, update or deletion of a TG (or other documents), the project milestones, and deliverables (OECD GD1, revised in 2009). It contains sections including the essential or additional information needed for the project proposal to be considered relevant at the WNT. A summary of such information is listed below, while more details can be found directly in the template available on the OECD TGP website.
- The Project scope (e.g. delete, update or create a TG, a GD or other OECD documents; e.g. Detailed Review Paper),
- Regulatory needs that the project replies to and the method contribution to the international harmonisation data requirements, including scientific arguments indicating the importance of the test or the proposed modifications.
- Beneficiaries of the project’s results (which OECD Member countries, which Stakeholder groups),
- The intended use, applicability, and limitation of the test method,
- The validation status of the test method, including essential measurands, minimum requirements for study design, key issues (statistics, analytics, test design) and data gaps foreseen.
- Statement regarding the Intellectual Properties Rights and the commercial availability of the equipments required,
- The animal welfare considerations associated to the project,
- The ressources saved by the Member countries in results of the project.
Exchange with your National Coordinator (NC) early on before planning to submit the SPSF.
The most recent Standard Project Submission Form (SPSF) template is freely available and can be discussed with either the OECD secretariat or your National coordinator, as it was not considered easily accessible or easy to fulfil by experienced leading institutions.
Circulate a draft SPSF early with your NC for him/her to indicate the intention of submission as a leading Member country leading to discussions on the project proposal with a sub-group of the WNT representatives (OECD GD1, revised in 2009).
The questions posed in the SPSF are important questions that should be considered early on during the initial pre-development or ideation of the project (e.g. method maturity, pre-validation, first outcomes and results, regulatory relevance, as well as Intellectual Property Rights (IPR) issues...).
If components of the methods are protected by a patent or IPR, a Fair Reasonable and non-discriminatory (FRAND) declaration to ensure global availability at a reasonable price, needs to be signed. Consult the OECD GD 298 for guiding principles on good practices for the availability/distribution of protected elements in OECD TGs that also provides the declaration form and contact your NC for further details on the process.
The SPSF helps throughout the method development phase at OECD as it sets the focus and it can be referred to later on (it is also a good guideline in case new colleagues are entering the project or taking over the tasks). Hence, one should think intensively about what to write in the SPSF but not be too ambitious and avoid changing the scope of the document during the process.
The advance of supporting science, the complexity and readiness of the test method, the presence of protected elements (i.e. Intellectual Properties), and the political landscape are factors that influence the time required for a project to go through the OECD process. Discussion with experts (inside OECD and outside OECD activities), and data collation and/or data generation required to cement a project proposal can take several years before its formal submission to the Working Group of National Coordinators of the OECD Test Guidelines Programme (WNT). Submission deadline by the leading Member country is the 15th of November every year. Consult the Project definition phase at OECD for further information on the timeline).
Extracted from the NanoHarmony Training Material – From science to standards and harmonised OECD Test Guidelines
‘The different OECD documents in the Test Guidelines Programme’
OECD Test Guidelines (TGs) are covered by the Mutual Acceptance of Data (MAD); data generated from the testing of chemicals in any OECD member or adherent country in accordance with the OECD Test Guidelines and Principles of Good Laboratory Practice (GLP) are accepted in all member and adherent countries in fulfilment of the same regulatory requirements.
The OECD TGs are mainly intended to be used by laboratories performing the tests for regulatory purposes, at the request of authorities in member and adhering countries. Therefore TGs need to be broadly available and transparently described while open to innovation (Intellectual Property Elements in OECD Test Guidelines - OECD).
Intellectual property rights (IPRs) aim to stimulate innovation by enabling innovators to appropriate the returns to their investments. IPRs play an important role in the creation, dissemination and use of new knowledge through the creation of trademarks or patents. The use and access of new test methods containing IPRs in a TG imply the creation of Material transfer agreements and licences. Such protected elements exist particularly within in vitro and in silico methods, but also in vivo test methods (see examples of protected elements in TGs). The owner of protected elements should sign a Fair, Reasonable And Non-Discriminatory (FRAND) declaration at the proposal stage of a TG (See Project definition at OECD and draft SPSF).
The Working Party of National Coordinators of the Test Guidelines Programme (WNT) will take into account the ability of the protected materials to decide whether the project should be integrated into the work plan of the OECD Test Guidelines Programme (TGP). Transparency is required from the moment a project proposal is submitted to the TGP. Not disclosing information and claiming confidentiality or trade secrets is against the principle of transparency and there is a risk that the project will not be taken up in the Programme (OECD GD298, 2019). At later phases, hiding or restricting access rights to protected elements is contrary to the principles of the OECD TGP and will result in the suspension of the project or cancellation of the TG (OECD GD298, 2019). National Coordinators (NCs) can be contacted for further details on the process.
The draft of a TG should be consistent with the general content and format of current existing Test Guidelines. There are several types of TGs depending on test methods and testing strategies under standardisation and harmonisation; e.g. Performance-Based Test Guidelines (e.g. OECD TG 455), Key Event-Based Test Guidelines (e.g. OECD TG 442D), or Defined Approach Test Guidelines (e.g. TG 497). The headings that appear in a TG template are listed below, while descriptions of the expected content for each section can be found directly in the relevant template available from the OECD Test Guidelines Programme Secretariat.
The aim should be for a clear and unambiguous document. With complex test subjects (e.g. advanced materials, nanomaterials, …) and complex methodologies, this can be challenging, but needs to be considered at all stages in the document development and in all sections of the document.
The terminology used in a TG is very important. The aim should be for all important terms to be defined clearly and unambiguously. Including a glossary in the document can be very useful in this context. The definition of terms used should be the same as those used in other TGs or other relevant OECD documents or, where terms have not been previously defined, generally consistent with the literature in the area. When deciding upon the appropriate definition for a term it is important to note that terms may have different meanings within different contexts (e.g., scientific, regulatory and legal).
Components of the draft TG that are also addressed in an existing TG (e.g., the housing and feeding conditions of animals, measurement principles etc.,) should be consistent with the existing descriptions unless scientific or animal welfare advancements require that changes be made (OECD GD1, revised in 2009).
Developers need to bear in mind that a TG is not a scientific text. Instructions in the text need to be explicit, e.g. by clear wording using terms such as, should, must, recommend, etc. This requirement may mean that further simplification of the methodology may need to be considered. Where an existing TG is being updated, the text of the existing version, annotated with the proposed changes, can prove a useful starting point for discussions with the Expert Group associated with the project (Ad Hoc or standing Expert Groups) (OECD GD1, revised in 2009).
The TG needs to be applicable throughout different national or regional jurisdictions due to the OECD MAD principle. Harmonisation and agreement are typically achieved through discussions with experts and Interlaboratory Comparison (ILC) participants but is time-consuming. Indeed, the drafting of a TG itself needs resources mainly in terms of expert knowledge and time, for drafting and reviewing the TG drafts and the associated Validation Report. The initial drafting, reviewing and revising is generally undertaken by the project lead with the (Ad Hoc) Expert Group. Once a strongly agreed draft is produced this is then provided for wider review by the Working Group of National Coordinators of the OECD Test Guidelines Programme (WNT) (See Commenting and approval phase at OECD).
Further information on the validation report can be found on the Validation, ILC and validation report page of this tool.
Start writing the Test Guideline (TG) as soon as the type of TGs is defined to identify any gaps and help define the validation steps needed. The timeline needed to obtain a complete and refined draft TG is highly dependent on the results and time needed for the validation of the test method (or testing strategy) under standardisation and harmonisation. It can also be time-consuming to find a consensus on the final draft TG and validation report as it ideally implies an agreement on the synthesis of the outputs of the validation study from the (Ad Hoc) Expert Group members supporting the project and the participants of the validation study. Consult Development phase at OECD for further information on the timeline of the overall phase.
Extracted from the NanoHarmony Training Material – From science to standards and harmonised OECD Test Guidelines
‘The different OECD documents in the Test Guidelines Programme’.
Guidance Documents (GDs) and other review documents (e.g. detailed review paper) provide further support in assessing the potential effects of chemicals on humans and the Environment. GDs can contain a more flexible test method or supplement one or more Test Guidelines (TGs) by providing technical guidance on how to use TGs for particular chemicals or materials. Sometimes it is preferable to target the development or update of a GD instead of a TG, when fast-going developments are expected for particular techniques or when missing important amounts of data for the validation of a test method that the funding won't allow to cover during the development phase at the OECD.
Indeed, GDs and other review documents (that provide the state of the art for a test method or scientific topic) are not covered by the Mutual Acceptance of Data and require (no to) limited validation efforts. There are no templates available for these documents to allow flexibility in their content. However, Member countries and institutions leading the development of such OECD documents still need to submit their drafts to the Working Group of National Coordinators of the OECD Test Guidelines Programme (WNT) for comments and approval at OECD. After approval by WNT and CBC, the documents are published in the OECD series on Testing and Assessment.
As an SPSF is also required to develop a Guidance document (GD) or a Detailed Review Paper or related documents, you are invited to consult the TIPS & TRICKS section of the ‘Draft a Standard Project Submission Form’.
Continues to cement the legacy with publications data to help the relevant Working Party of the Chemicals and Biotechnology Committee to select the most appropriate methods of testing strategies to be further developed into a Test Guideline.
The drafting process of OECD documents which are not subjected to the Mutual Acceptance of Data principle is expected to be less time-consuming than the drafting of a Test Guideline, which depends on the outputs of the Validation study. However, several meetings with the (Ad Hoc) Expert Group supporting the OECD project may still be required to refine and complete the draft document before its submission to the WNT (deadline for final document submission in February - Consult Development phase at OECD for further information on the timeline of the overall phase).