Regulatory decisions

There are no PSA requirements for licensing the current generation of nuclear power plants, i (PRA to the NRC) has been a tool for regulatory decisions b]... 

Although the petrochemical and metals industries were the primai y focus of the toxic air pollutants legislation, approximately forty of these substances have been detected in fossil power plant flue gas. Mercury, which is found in trace amounts in fossil fuels such as coal and oil, is liberated during the combustion process and these emissions may be regulated in the future. EPA issued an Information Collection Request (ICR) that required all coal-fired plants to analyze their feed coal for mercury and chlorine. Since these data will be used in making a regulatory decision on mercury near the end ot the year 2000, it is critical that the power industry provide the most accurate data possible. 

In terms of the influence exerted by the public and the private sectors on dmg regulation, these 10 countries can be placed along a continuum, as depicted in Figure 3.3 below. Cuba, where the Government has exclusive power over regulatory decisions, is at one extreme, and Australia, where consumers and the pharmaceutical industry have official representation and make recommendations to the TGA, at the other. 

At the micro level, all the country reports maintained that political pressure has little influence, if any, on dmg regulatory decisions. 

Tunisia Information on regulatory decisions provided No specific mechanism... 

Venezuela Information provided to interested parties Regulatory decisions published in official gazette... 

In Estonia, however, regulatory action is not taken on the basis of ADR reports sent by health professionals. This is because the SAM considers that the small number of reports made in Estonia forms an inadequate basis for regulatory decision-making. 

Review by supervisory body Dmg regulatory legislation normally specifies the official chain of command and the supervisory body to which the DRA must report. Administrative and legislative supervision is an important means of accountability if properly applied. However, supervision should not be used as a means of political influence over legitimate regulatory decisions. 

In order to set up a harmonized framework for the regulation of plant protection products in the EC, Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market was adopted and implemented in all Member States. Six annexes were established within this Directive, providing the basis for the harmonization of registration procedures and regulatory decisions (Table 1). 

Accurate, precise and sensitive analytical methods are important to the collection of data needed for regulatory decisions about pesticide registration. This article describes the various components of analytical method development, validation and implementation that affect the collection of pesticide residue distribution data for regulatory assessment of environmental fate and water quality impacts. Included in this discussion are both the technical needs of analytical methods and the attributes of study design and sample collection needed to develop data that are useful for regulatory purposes. 

The calculated MOEs in Table 3 demonstrate some of the problems with using this approach for characterizing risks and making regulatory decisions. Several of the exposure scenarios have MOEs of less than 10, which is the... 

In the past few years a variety of workshops and symposia have been held on the subjects of model verification, field validation, field testing, etc. of mathematical models for the fate and transport of chemicals in various environmental media. Following a decade of extensive model development in this area, the emphasis has clearly shifted to answering the questions "How good are these models ", "How well do they represent natural systems ", and "Can they be used for management and regulatory decision-making "... 

This volume will be of interest to toxicologists, immunologists, clinicians, and scientists working in the area of environmental health. It should also be of interest to individuals involved in occupational health, safety assessment, and regulatory decisions. Although we assume that most readers have at least some understanding of immunology, we have attempted to prepare this book so that any individual interested in environmental sciences could follow it. 

A recent report concerning the possible health hazards of di(2-ethylhexyl) phthalate (DEHP) and diisononyl phthalate (DINP), both used as plasticisers in flexible vinyl products has concluded that they are safe. This article supplies details of the general recommendations contained in the report. These emphasise the value of the plasticisers and strongly reinforce the need to be sure that regulatory decisions should be made based on sound science in a way that realistically assesses the likely exposure potential of adults and children. 

Risk Assessment. What is the incidence of the adverse health effects from the chemical agent This crucial question for regulatory decision making might be answered by combining the unit risk assessment with the exposure assessment. As In the exposure assessment, the question must be addressed in the context of one or more specific control policies. 

Information about exposure to infants, children, and other subgroups is then combined with toxicity information to determine the potential risks posed. If risks are unacceptable, the FDA and EPA will not approve the tolerances. Some of the EPA s recent important regulatory decisions, for example, were based on concerns about childhood or infant exposures, such as the elimination of the use of aldicarb on bananas and EBDCs on a number of fruits and vegetables. 

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