Mutual Acceptance of Data

In general, there are two types of Council Acts. A Council Decision, which is legally binding on OECD Member countries, and a Council Recommendation, which is a strong expression of political will. In the area of chemicals, for example, there is a Council Act relating to the Mutual Acceptance of Data (MAD, see below). 

Further information can be found at the OECD Web site (OECD 2006a). 

This program works on the development and coordination of environment health and safety activities internationally. 

30 Member countries and the OECD Secretariat work together to develop and coordinate chemical and pesticide related activities on an international basis. Part of working together includes MAD. 

The main objectives of the Chemicals Program are to assist OECD Member countries efforts to protect human health and the environment through improving chemical safety, to make chemical control policies more transparent and efficient and save resources for government and industry, and to prevent unnecessary distortions in the trade of chemicals and chemical products. 

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Work To Date. From 1977-80, the most intensive and productive OECD activities focused upon Mutual Acceptance of Data (MAD) and the development of test guidelines and GLP s. Efforts also were devoted to the Step Sequence Group and, in particular, that body s efforts to develop a Minimum Pre-Marketing Set of Data (MPD). Technical and scientific work also progressed on the various hazard assessment issues and expert groups worked on recommendations concerning confidential data, definitions of key terms, and principles of information exchange. 

In May 1980, the Chemicals Group endorsed recommendations from three of its groups concerning GLP s, test guidelines, and the MPD, and endorsed the principle of Mutual Acceptance of Data. Thereafter, the Environment Committee also endorsed these recommendations. 

A year later, in May 1981, the OECD Council considered these recommendations and issued a Decision establishing the following principle of Mutual Acceptance of Data (MAD) ... 

Member States shall take all measures necessary to ensure that the laboratories referred to in Article 7 of Directive 89/397/EEC1 comply with the general criteria for the operation of testing laboratories laid down in European standard EN 450013 supplemented by Standard Operating Procedures and the random audit of their compliance by quality assurance personnel, in accordance with the OECD principles Nos. 2 and 7 of good laboratory practice as set out in Section II of Annex 2 of the Decision of the Council of the OECD of 12 Mar 1981 concerning the mutual acceptance of data in the assessment of chemicals.4... 

ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT, Decision of the Council of the OECD of 12 Mar 1981 Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, Paris, OECD, 1981. 

The basis for mutual acceptance of data (MAD) is agreement on the test methods by which to test a chemical, and agreement on a system to ensure high quality and reliability of the data that are... 

OECD. 1997. Decision of the Council concerning the Adherence of non-Member Countries to the Council Acts related to the Mutual Acceptance of Data in the Assessment of Chemicals [C(81)30(Final) and C(89)87 (Final)]. http /webdominol.oecd.org/horizontal/oecdacts.nsf/linkto/C(97)114 OECD. 2004. Manual for Investigation of HPV Chemicals. Paris OECD, http //www.oecd.org/document/ 7/0,3343,en 2649 34379 1947463 l l l l,00.html OECD. 2006a. The OECD website, http //www.oecd.org/... 

Since 1997 a procedure through which non-OECD countries can adhere to the MAD system has been embodied in an OECD council decision (Council Decision on the Adherence of Non-Member Countries to the Council Acts Related to the Mutual Acceptance of Data in the Assessment of Chemicals C(97)l 14/FlNAL). A series of documents related to specific issues of GLP and comphance monitoring has been pubhshed (available on the OECD Web site, OECD 2006). 

The principles of GLP ensure the generation of high quality and reliable test data related to the safety of industrial chemicals, pesticides, pharmaceuticals, food and feed additives, cosmetics, veterinary drags as well as food additives, in the framework of harmonizing testing procedures for the mutual acceptance of data. 

It also comprises reporting and internal market (= mutual acceptance of data) requirements. The directive requires that the OECD Revised Guides for Comphance Monitoring Procedures for GLP and the OECD Guidance for the Conduct of Test Facility Inspections and Study Audits must be followed during laboratory inspections and study audits. 

Comparable quality of test data forms the basis for the mutual acceptance of data among countries. If individual countries can confidently rely on test data developed in other countries, duplicative testing can be avoided, thereby saving time and resources. The application of these principles should help to avoid the creation of technical barriers to trade, and further improve the protection of human health and the environment. GLP principles are explicitly presented below. 

Decision on the Mutual Acceptance of Data in the Assessment of Chemicals (C(81)30/Final). 

In addition to those items previously mentioned, the FDA is also participating in the development and use of international standards to facilitate pharmaceutical development. The goals of the International Conference on Harmonization of Technical Requirement for Registration of Pharmaceuticals for Human Use (ICH) is to facilitate the mutual acceptance of data submitted in support of drug marketing applications by the European Union, Japan, and the United States. The ICH has developed a number of guidelines and standards to harmonize post-marketing surveillance efforts on an international level. 

In 1981, the OECD Principles of GLP were finalized and led to the OECD Council Decision on the Mutual Acceptance of Data (MAD) which 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 shall be accepted in other member countries for purposes of assessment and other uses relating to the protection of man and the environment . The OECD recommended in 1983 that implementation of GLP compliance should be verified by laboratory inspections and study audits. The EC later ratified the OECD principles and a number of Directives (e.g., 2004/9/EC, 2004/10/EC) indicates that tests must be carried out in compliance with the principles of GLP and that also that EU Member States must incorporate into their laws the requirement for all nonclinical safety studies to be conducted in compliance with GLP, and that premises conducting such studies must be inspected by a national authority. 

The OECD Council, in its Decision concerning the Mutual Acceptance of Data in the Assessment of Chemicals [C(8i)3o(Final)] , decided that data generated in one member country in accordance with OECD Test Guidelines and the OECD Principles of GLP should be accepted also in other member countries, with the intention that such studies would not need to be repeated, nor the GLP compliance of such studies be questioned. In an analogous way, in its Decision-Recommendation on Compliance with Principles of Good... 

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