OECD Test Guidelines are globally recognised standards for the testing of chemical substances. They are closely linked to European chemicals legislation, and also indirectly influence occupational safety and health. A recent KAN study shows how these test guidelines are developed and how occupational safety and health perspectives can be presented during their development.
The KAN study, OECD Test Guidelines, Standardisation and Occupational Safety and Health (in German, English version in preparation), provides guidance for occupational safety and health experts in the form of general information on the OECD Test Guidelines and the process by which they are developed within the Organisation for Economic Co-operation and Development (OECD). In particular, the study highlights the opportunities available to experts to comment on and contribute to the test guidelines. It also explains the links between the OECD Test Guidelines and standardisation activity.
What relevance do the OECD Test Guidelines have to occupational safety and health?
The OECD Test Guidelines provide standardised test methods for assessing the physicochemical properties, toxicological and ecotoxicological effects and environmental behaviour of chemicals. The data collected by means of these methods is recognised by all OECD member states for regulatory purposes (Mutual Acceptance of Data). Serving as they do as the basis for the assessment of hazardous substances, the OECD Test Guidelines are particularly relevant to occupational safety and health.
The relevant European chemicals legislation in this context is, in particular, Regulation (EC) No 1907/2006 concerning the registration, evaluation, authorisation and restriction of chemicals (REACH) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP Regulation). These regulations oblige companies to provide data, for example by means of safety data sheets, on the risks and properties of substances. EU law establishes standardised test methods for the assessment of chemical substances, drawing on many OECD Test Guidelines for this purpose. Many technical standards also refer to these guidelines. Consequently, OECD Test Guidelines frequently serve as guidelines for the acquisition of data.
The data generated in this way also serves as the basis for occupational safety and health measures, as it is used to analyse workplace hazards and determine protective measures. Consequently, the OECD Test Guidelines have an indirect impact on occupational safety and health regulations and workplace practice despite being referred to explicitly neither in the German Hazardous Substances Ordinance (GefStoffV), nor in the TR Technical Rules for Hazardous Substances. The German Recommendation 409 on hazardous substances, concerning use of REACH information for occupational safety and health3, describes in detail the interaction and interfaces between the REACH Regulation and German occupational safety and health legislation.
How are OECD Test Guidelines developed?
OECD Test Guidelines are developed within the OECD by means of a multi-stage process. Responsibility for coordination lies with the Working Party of National Coordinators of the Test Guideline Programme (WNT), a body comprising national coordinators from all OECD member states. In Germany, the national coordinators are appointed by the Federal Environment Agency (UBA) and the Federal Institute for Risk Assessment (BfR).
New projects or proposals for amendments to existing test guidelines are submitted by the national coordinators. Among the conditions for inclusion in the work programme are a need for regulation and a contribution to international harmonisation of hazard and substance assessment. Once a project has been included in the work programme, a lead country or a working group produces a draft.
This is followed by several rounds of consultation. First, expert groups review the draft. The members of these groups are appointed by national coordinators as experts, rather than representing national positions. The first review is followed by the WNT consultation. During this stage, the national coordinators contact experts in their respective countries in order to draw up national comments with these experts’ support. In addition, selected external bodies such as the European Commission and the International Organisation for Standardisation (ISO) may also submit comments.
The draft is then adopted by the WNT. Following approval at higher level by the OECD Chemicals and Biotechnology Committee, the document is published and assigned an official TG number1.
How can the occupational safety and health community become involved?
Besides the national coordinators, the Federal Institute for Occupational Safety and Health (BAuA) plays an important role in Germany by monitoring the Test Guidelines programme with regard to its relevance to occupational safety and health. It also contributes actively to some of the OECD Test Guidelines and supports the involvement of researchers.
Although no provision is made as yet for occupational safety and health representatives to be involved systematically in the development of OECD Test Guidelines, various means exist by which technical expertise can be contributed to the process and occupational safety and health requirements submitted to it. Experts can support the national coordinators for example by applying to participate actively in an expert pool. Alternatively, experts may also contact the BAuA. The development process, including the opportunities for participation, is summarised comprehensibly on the ‘NanoHarmony’ project website. Current drafts of OECD Test Guidelines can be found on the OECD website.
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