Extracted from the NanoHarmony Training Material - From science to standards and harmonised OECD Test Guidelines
‘The process of development of OECD documents’
The pre-OECD phase involves activities prior to the development and submission of formal project proposals to the Working Party of National Coordinators of the Test Guidelines Programme (WNT). It is the phase during which regulatory needs are identified and ideas for potential projects are explored that could meet these needs. Only those ideas considered regulatory relevant and sufficiently advanced are expanded and developed for eventual formal consideration by Working Parties (WPs) of the Chemicals and Biotechnology Committee (CBC), which oversees and approves all of the work of the Environment, Health and Safety Programme of OECD (Consult the OECD page of this tool for further information). Many initial ideas or suggestions explored in this phase may be not retained for a variety of reasons (e.g. method development in its infancy with little evidence of robustness or relevance, requires equipment or material from a single provider with limited global availability).
Initial ideas may come from a variety of sources. Policymakers and regulators may be seeking a new test to address a new regulatory requirement or an alternative test that is more robust, cheaper, or easier than the current test method or complements an existing method. They may also identify a requirement for a test method more reflective of policy goals, i.e. related to objectives to reduce animal testing. Alternatively, they may want to amend a current Test Guideline (TG) because of issues identified with its performance or to make sure that it addresses a wider range of substances and materials (e.g. ensure the test method is suitable for testing nanomaterials). Coming from the other direction, scientists in academic or other research institutes may have developed a new method or technique to address a particular endpoint that they think may be useful within the context of regulatory risk assessment. Industry may also have ideas for new or improved test methods arising from their needs or their development of new equipment. Also, CROs and associated bodies may have ideas based on their experience with the regulatory system and associated testing procedures.
For a new project to be approved for inclusion in the OECD Test Guidelines Programme, the leading Member country (MC) and the associated leading institutions need to demonstrate both a clear regulatory need for developing a new or updated TG for the specific endpoint (mandatory) and also a sound scientific background to demonstrate biological relevance. Indeed, for approval of the project Standard Project Submission Form (SPSF) at WNT (See Project definition at OECD) it is necessary to ensure that the project responds to a global regulatory need (i.e. across multiple OECD MCss). The methodology should be sufficiently mature with a minimum of additional experimental activities (e.g. inter-laboratory comparisons) required to confirm that it can produce usable results for regulators. Similar requirements to demonstrate regulatory need also apply to projects submitted at WNT to develop or update Guidance Documents (GDs) or undertake Scoping Reviews (See the NanoHarmony Training Material - From science to standards and harmonised OECD Test Guidelines to learn more about the different OECD documents).
It is, therefore, very important that even at the very early stages in the discussions of a potential project, regulatory needs and the scientific appropriateness of the proposed approach are addressed as a priority. For a successful TG project, it is furthermore important to identify (a National Coordinator (NC) of) an MC or a country adhering to the Mutual Acceptance of Data (MAD) principle that is willing to lead the project through the OECD process (See WNT section of OECD description). A key support for these early discussions is your NC who can communicate your idea with other NCs and look for support within the WNT (See International NanoHarmony & NANOMET workshop on nano-related OECD TG; Recording day 2 from 49:26 to 52:24 min).
NCs also have an overarching view on existing TGss, ongoing WNT projects that might impact the proposal, and a good overview of what is going on in other documents under development (facilitates consistency). Due to their experience, they can advise on the appropriate OECD document to target with a project proposal (See Project definition at OECD). 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 standing Expert Group(s) of the WNT or other WPs of the CBC prior to a formal SPSF submission.
The consultation of international sector experts is highly recommended at the early stages of a potential OECD project. In developing their project proposal, some lead countries mobilise their own expert networks to ensure sufficient initial (financial) support before a document is formally transferred to OECD. Inputs from the experts on scientific progress and regulatory challenges can be collected during workshops, conferences, regulatory summits and in collaboration with multiple research projects susceptible to generate additional data if needed (See NanoHarmony Workshop on Gap Analysis and Data Requirements to support TG and GD Development). The exchanges should result in identifying the relevant SOPs, data requirements and data gaps to clearly define the project. Testing facilities should be consulted to ensure the practicability of the approach. To some extent, this may be a reiteration of the different aspects to fine-tune the project.
Identify science or method developments that meet the regulatory needs at different scales (national, European and international) and ensure the maturity of the science by selecting relevant test methods and Standard Operating Procedures based on their robustness, predictivity and practicality.
Seek support from your National Coordinator; check if he/she has an idea regarding the relevance of the potential project, and if he/she can connect you with the relevant institution (e.g. ECHA) and/or interested OECD Member countries.
Check existing and ongoing OECD projects in the OECD Test Guidelines Programme (TGP), consult the OECD TGP Work plan (emitted every year around June/July) and available status reports on regulatory and scientific challenges and needs, and find financial and resource support.
Initiate European and international cooperation to make your approach known to international stakeholders, consult international sector experts on scientific progress and find financial and resource support.
Seek long-term financial support; e.g. EU EU-funded projects, national governments, and industrial sponsors to cover any experimental work required to ensure the maturity of the science. Costs and personal time may also be required to engage with the relevant OECD Working Parties, and with a broad community of international stakeholders and sector experts during meetings, conferences, workshops and regulatory summits (e.g. travel fees).
Scientists suggest new scientific developments for uptake into a Test Guideline (TG), and/or support in the evaluation of the scientific background of methods that may be available in science or are specifically developed for a specific regulatory purpose in a Guidance Document (GD) or Scoping document. To allow them to take their role in the process, scientists will benefit from (a basic level of) knowledge of regulatory contexts and needs. To gain knowledge of regulatory context and processes, they should seek for exchange with regulators. Similarly, scientists should seek contact with the relevant OECD stakeholders (e.g. OECD secretariat, National Coordinators, Business & Industry Advisory Committee, ICAPO) to gain knowledge on standardisation and harmonisation processes. In many cases, however, their role is hampered by a lack of access to relevant (regulatory) data and/or limited funding for long-term support. To ensure that they have the necessary knowledge and access to data and funding, scientists need support from their National Coordinators (link with Working Party of National Coordinators of the Test Guidelines Programme (WNT)), research institutions and/or EU projects. For access to data and relevant knowledge, academic scientists should seek interactions with EU projects and other ongoing activities (e.g. through the EU Nanosafety Cluster), as well as involvement in Expert Groups, workshops and other activities of the OECD Test Guidelines Programme (TGP) (and/or other standardisation organisations).
The regulatory needs for harmonised test methods are identified and agreed upon by the Working Parties of the Chemicals and Biotechnology Committee (e.g. WNT or WPMN) to make recommendations to meet these needs. National Coordinators (NCs) and national delegates of the Working Parties can act as reference contact points between various stakeholders leading or participating in an OECD project. For example, regulators and risk assessors may contact their NCs to highlight a regulatory need for developing or updating a TG and may become leaders of a TG/GD project as they work for the project lead institutions. They may also support their NCs to ensure the TGs developed are regulatory relevant and deliver the information required for regulatory risk assessment decision-making.
The OECD secretariat of the OECD TPG assists countries in developing commonly agreed tools that can help the implementation of legislation in all the Member countries of the OECD. Regulatory needs in concomitance with the available scientific background are triggering the development or the adaptation of TGs/GDs. OECD acts as the organisation that oversees and gives directions from the point of view of regulatory applicability using inputs from National representatives and international stakeholders. It can also provide an overview and connect different stakeholders of the OECD with each other (e.g. between Working Parties and standing Expert Groups) and with any ongoing activities within the OECD Test Guidelines Programme.
Existing associations, networks and initiatives may assist in knowledge exchange, e.g. the NanoSafety Cluster connects different European research projects on nanomaterials with each other and with other global areas. The Malta Initiative has shown its use in the prioritisation of TG/GD development needs and successfully lobbying for (European) financial support, which resulted in the acceleration of the production of required data to form the basis of OECD TG/GD development (in EU projects like Gov4Nano, NanoHarmony, NANOMET and RiskGONE). The research projects also supported in sharing knowledge on the OECD process and by bridging stakeholders. Existing multi-stakeholder initiatives such as VAMAS may also be useful to connect to (potential) future users of TGs/GDs to ensure that they support the need and are available for consultation later on in the practicalities of performing a certain test.
Funding bodies(e.g. Lead countries, research institutions, EU-funded projects, industry) should be solicited to provide long-term financial support for the development of an OECD TG/GD.
Other stakeholders can provide different perspectives, and identify ambiguities, contradictions and missing aspects (e.g., Testing facilities can identify a need for developing or updating a TG).
Familiarise yourself with the OECD Test Guideline (TG) and Guidance Document (GD) development process; using the phases and processes pages of this tool and by reading the OECD GD1 (revised in 2009) and/or OECD GD34 (2005). Consult information available on the OECD Test Guidelines Programme website. If you have an idea to submit to the OECD Test Guidelines Programme and you are part of a group of projects, potential direct interaction with regulators for pre-screening of regulatory needs and relevance can occur through multi-stakeholder networks (e.g. the Malta initiative and NanoHarmony/NMBP13 projects). If you have an idea to submit to the OECD Test Guidelines Programme and you are not part of a particular network, speak to your National Coordinator (NC) for contact with other NCs and regulators from various OECD Member and non-member countries.
Initiate European and international cooperation to make your approach known to international stakeholders and sector experts. Participation in conferences, workshops regulatory summits, and collaboration with research projects will notably help you to apprehend regulatory and scientific challenges and needs. Raising awareness of the strategy developed by consulting as many stakeholders as possible (e.g. regulators, the scientific community and testing facilities) can be helpful to ensure (financial) support, add further details to clarify the approach and anticipate issues that might come up at later phases. This allows adjustments early in the process and smooths the commenting of the project proposal during the Project definition phase at OECD for example.
Prepare for the next phase i.e. project definition phase at OECD, by carefully designing the final target: is the objective to produce a GD, a TG or an Annex, or to adapt a GD or a TG? Consult the FAQ and the NanoHarmony Training Material to learn more about the difference between the different OECD documents,) but be ready to be flexible because sometimes part way through the process (e.g. in WPMN) a better output format for your project can be recommended (e.g. need for a detailed review paper in the first place to identify specific needs for method development).
If it is a revision of aTG/GD, contact the OECD secretariat which identifies the people involved in its development for you to contact and ask for help from the NC.
It is difficult to define neat timelines for this phase, as the development of a project often includes iterative processes. Identifying regulatory relevance or maturity of science that allows for practical implementation within a reasonable timescale is not always straightforward. Also, the identification of relevant individuals to be involved in the work is often an iterative process. Progress may also depend on other factors including the priority placed on the project, e.g. political pressure, and the availability of funding. Discussion with experts, and data collation and/or data generation required to cement a project proposal can take several years before its formal submission to the Working Party of National Coordinators of the OECD TGs programme (WNT). However, it is not necessary to have a complete project description at the end of this stage as this can be refined when the project enters the OECD process (See Project definition at OECD). In considering timescales in this phase it is important to bear in mind the deadlines required for submission of new projects to the annual WPMN or WNT meetings (See Timelines section of the Project definition phase at OECD).