There is no single way in which OECD Test Guideline (TG) and Guidance Document (GD) developments are financially supported. It often depends upon the country of the developer (i.e. leading Member country), or the timing of when resources may be available. Generally, priorities are identified in OECD meetings, then national authorities such those responsible for Human and Environmental Safety, can ask their ministries for funds to support the project leading institutions and other participating stakeholders to do the technical development. Generally, such calls take around 18 months to get advertised and will finance OECD TG/GD development for a maximum duration of 36 months.
Unfortunately, TG developments are often prolonged by missing or insufficient funding, typically longer than the normal three-year research project envisioned for the development of a test method. For example, the commenting and approval phase at OECD does not fit into the nature of usual research funding, in which projects finish short of the commenting rounds. The latter can be avoided if funding is sought and secured in advance which is one of the recommendations developed in the NanoHarmony White paper. Long-term funding that may be created by OECD Member countries is needed to help ensure that TGs are kept up-to-date and relevant to regulatory requirements, especially for new chemicals and materials, ensuring a prioritised and focussed approach.
However, it is clear that varying amounts of financial support are needed at the different phases of the OECD Test Guideline (TG) or Guidance Document (GD) development process.
-Method development- staff time to develop new methods. Laboratory work is required to develop new methods. $/€ Tens of thousands to hundreds of thousands.
-Project definition- staff time to support discussions at the Working Party on Manufactured Nanomaterials (WPMN) and the Working Group of National Coordinators of the OECD Test Guidelines Programme (WNT), exchanges with scientific experts, regulators and other stakeholders. Travel to meetings. Support for any remaining method development (lab work). $/€ hundreds to low thousands.
-Harmonisation of the test method and Standard Operating Procedure (SOP) - Staff time to support work. Initial laboratory costs for the intra and sub-set of interlaboratory comparisons. $/€ thousands to hundreds of thousands
-Interlaboratory comparison - Staff time to support and guide multiple laboratories. Multiple laboratory costs to run a comparison. Possibly additional steps are required for converting an SOP into a TG including TG drafting, agreement with experts, and responding to OECD experts. Possibly more extensive validation is required after the project for test method development purposes. $/€ Hundreds of thousands up to millions.
-Commenting phase - Dealing with comments and final drafting of TG. Staff time to manage the re-drafting of TG. $/€ Thousands to tens of thousands.
It should be noted that the different staff times relate to different tasks. Some of the staff time may be related to research and others to regulatory and OECD desktop work (e.g. reply to comments).
There is no one direct source that can be used to move a TG through the whole research and OECD development process and often different sources of funding will need to be identified and used at different stages of the process. Some ideas about the different sources of financial support that may be available to TG developers including regional, national, European or international level from different ‘funding agencies’ are as follows and some tips and guidance are provided for when these would need to be accessed and which phases they are likely to be useful for.
- Government Funding (from annual budget) - Government funding coming from the annual budget can be used at all stages and for all types of work during the whole phase of development. Certainly, governmental rules of the corresponding countries, ministries and agencies apply. Typical ministries to contact relate to research, the safety of the environment and humans, chemical safety, business and industry. Since it is from the annual budget it needs to be in the budget planning at least 12 months in advance and lobbying should start already 12 months before budgeting.
- Government Funding (from additional award) - Governments sometimes open up special funds and calls or even create such a fund (after lobbying). It may be useful for all stages of research and TG development. Support needs to be sought with enough time to ensure it fits within annual budgets. That is not guaranteed in every country and may not be standard practice in some countries. It sometimes helps to have specific tasks being identified and priorities by the OECD.
- Own Funding (private sector) - Companies can use their own funding to support the TG development process. Support is usually in the form of staff time for attending relevant meetings or support for interlaboratory trials using the company’s own facilities. Companies would usually only fund TG developments for method innovations that they had themselves directly developed or for TGs developed by others that had a direct impact on their work. Companies would also usually fund their own staff for involvement in TG development as experts or to attend relevant OECD meetings.
- Project Funding (EU) - Project funding from the European Commission (for example Horizon Europe funding) would usually be for pre-OECD work, such as the scientific work to develop a new method. Due to funding regulations of research projects, it is unlikely to be able to support a TG through the OECD process itself.
- Project Funding (national funding) - Similar to Project Funding (EU), national funding would usually be used for pre-OECD work on new method development and is not available to support a TG through the OECD process.
- Project Funding (other) - Other project funding may come from Public Private Partnership or private foundations which possibly can be used for all stages of development depending on the corresponding rules. Anyhow, funding may most likely be for the development and validation steps. Information has to be sought from the various websites of the foundations.
- Other - Other funding may be available for TG development which has not already been mentioned, and the easiest way to learn of these and what is possible in your situation is to speak to people who have developed similar TG/GD topics in your country.
It is difficult to secure a single source of funding to support the entire duration of the process of developing an OECD TG/GD. It is prudent to start to look for financial support as early as possible (See Pre-OECD phase). TG developers should speak with their National Coordinators as soon as possible to discuss their funding requirements and to start to put together a plan for taking their TG development forward through the OECD process.