Government and industry are concerned about the quality of non-clinical health and environmental safety studies upon which hazard assessments are based. As a consequence, OECD member countries have established criteria for the performance of these studies.

In the framework of the OECD Consensus Workshop on Good Laboratory Practice, held 16-18 October 1990 in Bad Dürkheim, Germany, a working group met to discuss and arrive at consensus on Good Laboratory Practice and the role of Quality Assurance (QA). The working group was chaired by Dr. Hans Könemann (Head, GLP Compliance Monitoring Authority, the Netherlands).

In the framework of the Revision of the OECD Principles on Good Laboratory Practice, the Expert Group was not able to reach consensus on whether and how to deal with the role and responsibilities of the sponsor of chemical safety studies in the Principles. The revised Principles of GLP contain several explicit references to the sponsor, and the issue is implicit in several other principles. However, there was no agreement on the need for and content of a separate section in the Principles on this matter.

The 1981 Council Decision on Mutual Acceptance of Data [C(81)30(Final)], of which the OECD Principles of Good Laboratory Practice are an integral part, includes an instruction for OECD to undertake activities “to facilitate internationally-harmonised approaches to assuring compliance” with the GLP Principles. Consequently, in order to promote the implementation of comparable compliance monitoring procedures, and international acceptance, among member countries, the Council adopted in 1983 the Recommendation concerning the Mutual Recognition of Compliance with Good Laboratory Practice [C(83)95(Final)], which set out basic characteristics of the procedures for monitoring compliance.

Environmental health and safety studies for the assessment of chemicals and chemical products are increasingly being carried out in multiple sites. This holds not only for field studies, but also for various phases of toxicology studies. The Revised Principles of Good Laboratory Practice, adopted by OECD in 1997, cover the various aspects of the organisation of such studies.

The OECD is not a supranational organisation, but rather a forum for discussion where governments express their points of view, share their experiences and search for common< ground. If member countries consider it appropriate, an accord can be embodied in a formal OECD Council Act, which is agreed at the highest level of OECD, the Council.