Mutual acceptance data

Informed debate and decisions on such important matters as the depletion of the ozone layer, acid rain and the quality of waterways all depend on the data provided by analytical chemists. Forensic evidence also often depends on chemical measurements. National and international trade are critically dependent on analytical results. Chemical composition is often the basis for the definition of the nature of goods and tariff classification. In all of these areas not only is it important to get the right answer but it is essential that the user of the results is confident and assured that the data are truly representative of the sample and that the results are defendable, traceable and mutually acceptable by all laboratories. 

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. 

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). 

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/... 

It is possible to conduct animal studies in an infinite number of ways. Although individually designed studies are often scientifically sound, and in many cases serve a particular purpose very well, they pose problems in a regulatory context. Free movement of chemicals between countries is based on the mutual acceptance of the risk evaluation made by each country and this, in turn, relies on the mutual acceptance of the data generated when testing the chemicals. Experience has shown this acceptance to be extremely difticult, if chemicals have been tested by different methods. 

As a tool to make mutual acceptance of risk assessments possible, OECD has developed the concept of Good Laboratory Practice (GLP). The OECD Principles of GLP are an integral part of the 1981 OECD council decision on the Mutual Assessment of Data (MAD) in the Assessment of Chemicals (revised 1997, Section 2.2.2). MAD also harmonizes procedures of GLP compliance monitoring, ensuring that preclinical safety studies are carried out according to the principles of GLP and that countries can have conftdence in the quahty and rigor of safety tests. 

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. 

European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions/ ... 

The prerequisite for the mutual acceptance of analytical data such as pH is comparability. Comparability requires the complete evaluation of the measurement uncertainties which in turn are based on traceability to recognised references. The need for traceable pH measurements and the confusion resulting from the ambiguous IUPAC recommendation led to various international initiatives being taken. 

To monitor and update harmonized technical requirements leading to a greater mutual acceptance of research and development data. 

These factors have been studied by many workers however, no mutually acceptable concepts with regard to the significance of each of these factors have been developed. This has been due in part to the contradictory data appearing in the literature. 

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