Mutual acceptance

Although the application may look complex and time consuming the overall approach being taken by the regulating bodies is one of partnership, and constructive help is offered with the aim of reaching a mutually acceptable agreement. 

National Tests. It is clearly possible to remove the technical barrier to trade represented by different national fire test procedures, by providing a facility for a manufacturer to conduct the relevant tests once and within his home country, with a guarantee of acceptability of the results by all Member States. This requires laboratories to equip themselves with all the necessary equipment and for an extensive interlaboratory collaboration and calibration procedure to be introduced, which would ensure mutual acceptance of test results. 

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. 

Litigation is not always the only or best way to resolve conflicts. Mediation offers an alternative approach and it is one that can be quite efficient and successful. Mediation can be faster, less expensive, and can lead to creative solutions not always possible in a court of law. Additionally, mediation focuses on mutually acceptable solutions, rather than on winning or losing. 

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. 

Reference materials must fulfill certain rigorous criteria before they are accepted and found useful by the analytical community. The following conditions are prerequisites for preparing reference materials that are mutually acceptable to organizations around the world ... 

Barelmann I, Uria Fernandez D, Budzikiewicz H, Meyer JM (2003) The Pyoverdine from Pseudomonas chlororaphis D-TR133 Showing Mutual Acceptance with the Pyoverdine from Pseudomonas fluorescens CHAO. BioMetals 16 263... 

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 primary objective of laboratory personnel is to prodnce qnality resnlts that are mutually accepted. The harmonization of the laboratories to the CLP principles will benefit the global economy by the avoidance of the technical barriers to trade and the duplication of analytical determinations. In addition, CLP will improve the quality of life via the protection of human health and the enviromnent. 

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. 

Part B of Annex 1, provides guidance for the conduct of test facility inspections and study audits which would be mutually acceptable to OECD member countries. It is principally concerned with test facility inspections, an activity which occupies much of the time of GLP inspectors. Test facility inspections are conducted to determine the... 

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. 

The NHS Trust shall notify the Sponsor if [... insert name of investigator. ..] ceases to be employed by or associated with the NHS Trust, and shall use its best endeavours to find a replacement acceptable to both the Sponsor and the NHS Trust. If no mutually acceptable replacement can be found the Sponsor may terminate this Agreement pursuant to clause 12.3 below. 

---