Mutual acceptance of data: harmonised test methods and quality assurance of data—the process explained

• Published in: Toxicology letters Vol. 140; pp. 11 - 20
• Main Author: Koëter, Herman B.W.M
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ireland Ltd 11-04-2003
• Subjects: Animals; Clinical Laboratory Techniques - standards; Environmental Health - standards; GLP; Guidelines as Topic - standards; Hazard assessment; Humans; OECD; Quality Control; Societies, Scientific; Test methods; Toxicology; Test methods; GLP; OECD; Hazard assessment
• ISSN: 0378-4274; 1879-3169
• DOI: 10.1016/S0378-4274(02)00491-5

An essential aspect of the OECD is that it should not be considered a supranational organisation, but rather a center for discussion where governments express their points of view, share their experiences and search for common ground. This implies that decisions are made by consensus instead of majority. Once the Council, which is the highest authority of the OECD, adopts a formal Decision, such a decision is binding on all Member countries. The OECD Guidelines for the Testing of Chemicals, which are considered the leading international standard for safety testing, form an integrated part of such a binding Council Decision. An even more important part of that same Council Decision is that on Mutual Acceptance of Data, where it states that: ‘Data generated in the testing of chemicals in an OECD Member country in accordance with OECD Test Guidelines and OECD Principles of Good Laboratory Practice (GLP) shall be accepted in other Member countries for purposes of assessment and other use relating to the protection of man and the environment.’ In the various steps of the process of Test Guideline development, the National Co-ordinators of the Test Guideline Programme play an important role. The initiative to start the development of a particular guideline can be taken by the OECD Secretariat, by one or more Member countries or, most importantly, by the scientific community itself. Proposals, received by the Secretariat are discussed at the yearly Meeting of the National Co-ordinators. During these meetings, priorities for future activities are set and the approach that should be followed in dealing with the selected activities is discussed. Quite often, so-called Detailed Review Papers (DRP's) form the basis of a new or updated Guideline. These DRP's, which are either prepared by a Member country or by a consultant appointed by the Secretariat, describe the current ‘state of the art’ in scientific progress and technical possibilities of a well-defined area of research. After completion, either an expert meeting or a commenting round will be organised. All Member countries will have sufficient possibilities to express their views. When the DRP is acceptable to the experts of all Member countries, the next step is to actually develop a Test Guideline. Similar to the procedure followed for the DRP, the Test Guideline proposal will be circulated for comment to all Member countries and should reach the desks of relevant experts, nominated by their National Co-ordinator. Frequently, in addition to the commenting rounds, Test Guideline proposals are discussed in special expert meetings. Once the experts reach consensus on a particular Test Guideline, the proposal is put forward to the Meeting of the National Co-ordinators for approval. Since each guideline will form an integrated part of the earlier mentioned Council Decision, each new guideline also needs formal adoption by the Council before it becomes effective.