The Regulatory Infrastructure

The Health and Safety at Work Act 1568/85, was the first attempt at modem health and safety legislation was which contained the general health and safety duties of employers, provisions for worker representation and requirements for employers in larger enterprises to appoint occupational healdi and safety professionals to advise them on carrying out their responsibilities. Article 26 of Chapter V (echoing Dir.80/1107/EEC) obliges the emplo r to take measures to avoid or minimize the exposure of workers to hazardous agents, wherever this is practicable. In all events the level of exposure must be lower that the level defined as the exposure limit value . 

D ite these provisions there is little evidence to show that following their introductimi any significant chan took place in arrangements for the health and ety of ttie vast majority of Greek workers. This was mainly because their applit on was severely restrict to woilq)laces above minimum sizes in which only a minority of the working population was employed (Walters 2001 197-202). It was also because there was a short e of qualified OHS professionals to provide the necessary support capacity even for the restricted number of workplaces covered. It was not until the adoption of the Framework Directive 89/391, which was transposed by Presidential Decree 17/96 in 

Prior to this the main legislation cm health and safety was contained in the 1934 Presidential Decree which was prescriptive l islation in a similar tradition similar to the UK Factories Acts. Curiously, it had quite strong requirements on safety in relaticm to chemical substances including smasures on classification and packaging of dangerous substances as well as special prov ons on die removal of dusts and fumes. 

Indeed, in the years following the Act there were so few professionally qualified occupational physicians that the state was forced to accept qualifications in other branches of medicine such as drorasic and cardiac medicine as dieir equivalent in order that enployers who were obl ed to do so could employ a physician to advise on occupational health. 

While a law is discussed and voted in Parliament, a Presidential Decree is singly signed by a Minister and approved by the President of the Rqiublic. It nevertheless has the fince of law. 

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The Regulatory Infrastructure within China in the Regulation of Pesticide... 

There are other kinds of records that should be maintained as part of the regulatory infrastructure but which may not be held in the possession of the regulatory body. Such records should be made available to the regulatory body... 

Achieving the minimum benefits of exemption would require few changes in the existing regulatory infrastructure other than those... 

National approaches to risk management are strongly established within France, Germany, Sweden, and the UK. The national approaches have evolved over many years involving complex socioeconomic and cultural phenomena. In turn, the regulatory culture is reflected in the country s administrative infrastructures. Fiistorical and social contexts, such as the legal systems and industrial relations, provide some explanation as to how and why differences occur in national approaches to chemicals policy and risk management. 

FAO International Code of Conduct on the Distribution and Use of Pesticides The 1985 International Code of Conduct, amended in 1989, was developed to address the use of pesticides in developing countries until the countries have established regulatory infrastructures for pesticides. The Code sets forth responsibilities and establishes voluntary standards of conduct for public and private entities engaged in or affecting the distribution and use of pesticides. The Code specifically addresses Labeling, packaging, storage and disposal of pesticides. 

Considerable effort is required for the preparation of technical reports, specialized presentation to development teams, regulatory interactions, and pubhcations and presentations (see also Chapter 37). The efforts required to produce these materials are frequently duphcative and may at best involve repurposing content, requiring considerable rework and editing to achieve the desired content, only to realize that specific information is not readily available or was not previously generated during an appropriate opportunity in the pharmacometrics process. This issue speaks to important deficiencies in the representational infrastructure of pharmacometrics and is addressed further in Section 36.4.2. 

Clearly, there are no one-size-fits-all answers. Many factors enter into the decision to favor either policies that lean more toward economic incentives (El) or toward direct regulation, or what is commonly referred to as com-mand-and-control (CAC) policy. Underlying determinants include a country s governmental and regulatory infrastructure, along with the nature of the environmental problem itself. 

How can a pharmaceutical company prevent a complaint from the regulatory authorities The answer is to establish a quality system infrastructure to govern the acquisition and development of software and the acquisition and operation of hardware. Such a system should be implemented for both regulatory compliance and cost savings ... 

There are doubts regarding the long-term integrity of storage media (magnetic tapes, floppy disks and even compact disks) that contain records associated with pharmaceutical product development and analysis. The possibility that these media could lose data is of great concern to the regulatory authorities. It is therefore an issue that pharmaceutical manufacturers must address as part of the LIMS infrastructure implementation. Periodic restoration of data verifies that the data are intact and confirms the restore procedure is operable. 

The IAEA Safety Requirements publication on Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety [ 1 ] sets out the requirements for a regulatory infrastructure. These include requirements in respect of the establishment of an independent regulatory body for nuclear facilities and the responsibilities and functions to be assigned to it. 

This Safety Guide, which is jointly sponsored by the FAO, the IAEA, the International Labour Office, the PAHO and the WHO, gives detailed guidance on the key elements for the organization and operation of a national regulatory infrastructure for radiation safety, with particular reference to the functions of the national regulatory body that are necessary to ensure the implementation of the Basic Safety Standards. The Safety Guide is based technically on material first published in IAEA-TECDOC-1067 which was jointly sponsored by the FAO, the IAEA, the OECD/NEA, the PAHO and the WHO. The requirements established in GS-R-1 have been taken into account. 

The Safety Guide is oriented towards national regulatory infrastructures concerned with protection and safety for radiation sources used in medicine, industry, agriculture, research and education. 

The IAEA safety standards need to be complemented by industry standards and must be implemented within appropriate national regulatory infrastructures to be fully effective. The IAEA produces a wide range of technical publications to help States in developing these national standards and infrastructures. 

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