Council decisions

EEC Council decision on a monitoring mechanism of community CO2 and other greenhouse gas... 

Any person importing hazardous waste into the United States from a foreign country is subject to hazardous waste generator standards. RCRA also contains specific requirements for hazardous waste exports. Importers and exporters must also comply with the provisions of international trade treaties, such as the Basel Convention and the Organization for Economic Cooperation and Development (OECD) Council Decision. 

Test facilities in the OECD (Organization for Economic Co-operation and Development) member countries that conduct regulatory studies must comply with the OECD Principles of Good Laboratory Practice (GLP), as set out in Council Decision C(97)186/Final. These are referred to as GLP Principles. GLP came into prominence in the late 1970s in response to some malpractice in research and development activities of pharmaceutical companies and contract... 

It consists of ambassadors or ministers from each of the member countries. The Council usually reaches one of two types of cooperative agreements with regard to the major subjects that come before it.(33) Council Decisions are binding upon all Members, who must implement them in accordance with appropriate national procedures and requirements. Recommendations, on the other hand, are not binding, but are submitted to the Members who then must decide whether to implement them through their own national laws. Thus, the exact status of a particular Council action is significant insofar as whether it requires, or only suggests, implementation at the national level. 

This change in official U.S. policy came as a result of lobbying that the American chemical industry (primarily the Chemical Manufacturers Association (CMA)) undertook with the new Administration after it assumed office in January 1981. The major concern that CMA stated was that the proposed Council Decision on MPD, as written, might legally bind the U.S. to amend TSCA and require the MPD as part of PMN s in this country. CMA long had opposed any concept of base set" testing for all new substances under TSCA, and viewed the MPD, particularly if incorporated in a Council Decision, as being directly contrary to that position. 

At the time of the Council Decision, approximately 50 guidelines were in final form. An equal number were in various stages of drafting, and are to be incorporated into the Annex as they are completed. 

National Research Council, "Decision Making for Regulating Chemicals in the Environment" National Academy Press Washintgon, D.C., 1977. 

Council Decision 88/389/EEC on inventory of the source materials and substances used in the preparation of flavourings... 

Council Decision 88/389/EEC of 22 June 1988 on the establishment, by the Commission, of an inventory of the source materials and substances used in the preparation of flavourings (Official Journal of the European Communities (L184) of 15 July 1988, p. 67). 

The draft decision is then sent to the Standing Committee on Medicinal Products or the Standing Committee on Veterinary Products for their opinions. Should there be detailed opposition from a member state to the draft decision, the standing committee can refer it back to the CPMP if the opposition is scientific. If the matter is nonscientific, the council decision is made on the basis of a qualified majority, where each member state has a different number of votes depending on its size and importance and the majority of votes must be in favor. If within a further 30 days there is no opposition, the draft decision is forwarded to the Commission secretariat-general for adoption, enabling the Commissioner for enterprise and the information society to issue the final decision which is published in the Official Journal of the European Communities. 

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 1981 Council Decision (OECD 1981) sets the policy context agreed by aU OECD Member countries which estabhshed that safety data developed in one Member country will be accepted for use by the relevant registration authorities in assessing the chemical or product in another OECD country, i.e., the data do not have to be generated a second time for the purposes of safety assessment. 

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. 

The 1989 OECD council decision Recommendation on Comphance with Good Laboratory Practice requires the establishment of national comphance monitoring program based on laboratory inspections and study audits and recommends the use of the guides for comphance monitoring procedures for good laboratory practice and the guidance for the conduct of laboratory inspections and study audits. 

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 Aimex I of the Directive 2004/9/EC consists of two parts Part A (Guides for compliance monitoring procedures for good laboratory practice) and Part B (Guidance for the conduct of test facility inspections and study audits). The provisions for the inspection and verification of GLP which are contained in Parts A and B are those contained in Annexes I and II respectively of the OECD Council Decision-Recommendation on comphance with principles of good laboratoiy practice. 

The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission ( ),... 

The CRLs are currently implementing programs to monitor the performance of the National Laboratories. The powers and conditions of operation of the CRLs concerning the examination of animals and fresh meat for the presence of residues are defined by the EU Council Decision of 6 March, 1989 (62). Their major tasks and duties are as follows ... 

In view of these findings, FDA has placed no restriction on the commercial use of milk and meat from cows treated with rBST. In contrast, the European Union has opposed the use of this hormone, thus complicating the trade of dairy products with the United States. Council Decision 94/936/EC states that rBST is an issue that gives rise to considerable interest among consumers, agricultural, and industry interests. In this context, concerns have been expressed about the safety to humans, animals, and the environment the quality of milk the economic and social consequences in agriculture the climate for research and development, industrial competitiveness, and trade implications. 

The publication of BS EN ISO 9001 2000 has implications for Council Decision 93/465/EEC of July 22, 1993 concerning the modules for the various phases of conformity assessment procedures and the mles for affixing and using the CE conformity marking, which are intended to be used in the technical harmonization directives. It is important to note that the modules used in individual technical harmonization directives may vary in some respects compared to those described in Council Decision 93/465/ECC. In all cases, it is the annex of the applicable directive(s) that is legally binding. The principles set out in this foreword remain valid regardless of these variations. 

Three of the modules cited in the council decision, i.e., modules E, D, and H, require that the manufacturer must operate an approved quality system. The scope of the quality systems required by these modules addresses ... 

In addition, the premise that Jackson alone represents the achievements of the entire city council does not make sense. The premise is based on the entire council s track record, which may or may not indicate Jackson s personal ideas or set of values. The author lumps Jackson together with the city council—it is important to remember that decisions the council makes are not his decisions alone. In fact, he may have supported measures to improve education that the entire council didn t pass. The connection between the relationship of a single city council member and problems with the education system is unsupported and weakens the author s argument. Jackson alone is not responsible for the outcome of city council decisions—other members have say in the decisions and intentions of other members of the town council. 

EUROPEAN COMMUNITY, Council Decision 93/315/EEC of 19 May 1993 on a limit for the total mercury content of the edible parts of fresh fish , Official Journal of the European Communities L144 23-4. 

Regulation (EC) No. 1882/2003 of the European Parliament and of the Council of 29 September 2003 adapting to Council Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in instruments subject to the procedure referred to in Article 251 of the EC Treaty. Official Journal, L 284, 31/10/2003, 0001-0053. 

The Organisation for Economic Cooperation and Development s (OECD s) 1987 Council Decision-Recommendation on the Systematic Investigation of Existing Chemicals stated, Member Countries should establish or strengthen national programmes to systematically investigate existing chemicals. ... 

A further OECD Council Decision in 1991 focused on HPV chemicals. These decisions prompted the development of a minimum hazard data set to describe an HPV chemical - the Screening Information Data Set, or SIDS. This includes physicochemical properties (melting point, boiling point, vapor pressure, water solubility, and octanol-water partition coefficient) environmental fate (stability in water, photodegradation, biodegradation, and an estimate of distribution/transport in the environment) environmental effects (acute toxicity to aquatic vertebrates, invertebrates, and plants) and human health effects (acute toxicity, repeated-dose toxicity, toxicity to the gene and the chromosome, and reproductive and developmental toxicity). 

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