Drafting OECD documents

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.

TG Information requirements

- Draft Title,
- Introduction,
- Definitions,
- Initial considerations and limitations,
- Principle of the test,
- Information on the test chemical,
- Demonstration of Proficiency,
- Validity of the test,
- Description of the test method,
- Test procedure,
- Interpretation of results/prediction model,
- Data and reporting,
- Annexes.

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.

• Find out about the different possible structures of Test Guidelines (TG). The structure has changed over the years: consider the current template and a TG recently published as a reference document.
• Start writing the TG at an early stage to identify any gaps and help define the validation steps needed.
• Circulate the draft TG among the (Ad Hoc) Expert Group and, if an ILC has been undertaken, participants of the interlaboratory comparison (ILC). They should be experts in the area and can give valuable advice as the draft TG is usually prepared based on the standard operating procedure and the validation report.
• For a lean draft TG refer to the validation report for details in technical specifications. Details of the validation report are covered in the validation and ILCS section (See Validation, ILC and validation report).
• Regarding key political considerations, it should be kept in mind that the development or the adaptation of a TG should always be in response to a regulatory need, be mindful of animal welfare and consider the economic implications of the proposed testing. As OECD Member countries (MCs) agree by consensus to the final TGs, it is important to identify any areas of concern and divergent interests of the different MCs and countries adhering to the OECD Mutual Acceptance of Data principle at the early stages of its development. This can be ensured with the support/involvement of different National Coordinators. Similarly, collaboration between the different stakeholders of the OECD Test Guidelines Programme (TGP) is needed to ensure that the glossary and terminology developed within a TG is appropriate. All the received comments should be dealt with before the submission to the WNT.
• Ensure that protected elements of the TG are accessible and respect the principle of transparency of the OECD TGP with the support of your NC. 

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.