Body, regulatory

To be effective, the regulatory body shall be provided with the legal powers and statutory authority necessary to ensure that it can discharge its 

The licensing process may vary among Member States but in all cases the major stages of the licensing process for nuclear research reactors shall include the regulation of  

Although the utilization and modification of research reactors are activities that are normally included under operation, they may be considered separate stages in the Ucensing process since their safety impUcations give rise to a large nnmber of review and assessment activities that are repeated many times over the reactor s lifetime (see paras 7.87-7.94). 

Beyond the items discussed in paras 3.7 and 3.8, the SAR shall include additional information as prescribed in national legislation and by the regulatory body. Guidance on the information to be included in a typical SAR is presented in Ret [7]. The level of detail of the information to be presented in the SAR shall be determined in accordance with the type, characteristics (its 

The operating personnel comprise the reactor manager, the shift suf)ervisors, the of)erators, the maintenance staff and the radiation protection staff. 

The format and content of documents submitted by the operating organization in support of a licence application should be based on the information presented in this Safety Guide. However, the regulatory body may require additional information, depending upon the regulatory practices of the Member State. 

The review and assessment of the information by the regulatory body is a continuous process. Sections of the SAR or other documents shall be submitted to the regulatory body at an early stage, in accordance with an agreed progranune (see para. 222). This approach will permit a systematic assessment and approval procedure and will prevent unnecessary delays in the licensing process. 

The regulatory body shall be responsible primarily for determining that the proposed research reactor can be sited, constructed, conunissioned, operated, utilized, modified and decommissioned without undue radiological risk to the site personnel, the general public and the environment. In connection with this, the regulatory body shall  

The primary basis for the review and assessment of the nuclear safety aspects of the proposed reactor is the information contained in the SAR submitted by the operating organization. The regulatory body shall make a determination regarding the following points  

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Deahngs with state and local regulatory bodies... 

The first group, i.e. simple laboratory tests, is frequently criticised in that, although results may be reproducible, they do not give a good indication of how the material will behave in a real fire situation. On the other hand, the second group is criticised because correlation between various tests proposed by different regulatory bodies is very poor. In spite of these limitations there are, however, a few tests which are very widely used and whose results are widely quoted. 

It should be clear that a complete FMEA approach is not practical for the evaluation of production facility safety systems. This is because (1) the cost of failure is not as great as for nuclear power plants or rockets, for which this technology has proven useful (2) production facility design projects cannot support the engineering cost and lead time associated with such analysis (3) regulatory bodies are not staffed to be able to critically analyze the output of an FMEA for errors in subjective judgment and most importantly, (4) there are similarities to the design of all production facilities that have allowed industry to develop a modified FME.A approach that can satisfy all these objections. 

Refngeration technology is moving into a new phase with the introduction of hydrofluorocarbons that combme the safety of chlorofluorocarbons with a much lower environmental impact The considerable care bemg taken to choose the new refngerants under the close scrutmy of the public and regulatory bodies will ensure that the new products wiU benefit mankind for years to come... 

Regulatory bodies at both the federal and state level attempt to ensure that electric power is provided economically, and in a safe and reliable manner. The primary method of electricity regulation has been rate of return, or cost-based, regulation. Here regulators set the rates utilities are allowed to charge their customers. This cost-based regulation allows... 

In addition to the formal committees specified in directives, the commission is assisted by other expert committees and working groups. Depending on the subject matter, these can be drawn from the regulatory bodies, the scientific community, or industry and end-user associations. 

Member states can nominate one expert and an alternative to each committee. These in effect come from the national regulatory bodies, which they also represent. The committees may additionally co-opt up to five other members. The committees can draw on the expertise of some 3500 scientists using a network that extends through the national regulatory bodies, and so form further advisory committees and working groups as appropriate. 

Thus, even under Regime 2a, the manufacturer will set in house limits (IHL) that are sufficiently narrow to reduce the risk of a recall from market (and all the attendant publicity) to very low levels. (See Fig. 2.13.) The risk resides in the possibility that a customer or a regulatory body reanalyzes samples and declares fails even if the manufacmrer s QC lab found complies. Many things could be at fault in either location, such as equipment, operator training, availability of proper standards, etc., but once a suspicion is raised in public, industrial science takes a back seat. 

Before a new drug can be released on the market, it must be formulated to produce a quality product that is acceptable to both regulatory bodies and patients and can be manufactured on a large scale. There are many formulation types depending on the route of administration of the active drug. 

The approved color additives appear on positive lists issued by the Food and Drug Administration in the US, the EU, and Japan, but the colorants permitted in each market vary considerably. US and EU regulatory organizations provide provisional and permanent lists of approved color additives. The permanently listed additives are considered safe for use in cosmetic and toiletry products by the regulatory bodies. Provisionally listed color additives are those on which some safety studies are still to be undertaken or their test results are under review. The Japanese regulations include only a permanent list of color additives. 

Graham et al.79 noted that more than a quarter of Canadian youth surveyed reported use of caffeine during the last year to improve their athletic performance. The current allowable levels of caffeine permitted by the IOC are well above the minimum dose needed to elicit an ergogenic effect. If the IOC and other regulatory bodies are serious about controlling the use of performance enhancing drugs, then it may be necessary to ban caffeine entirely from competition. 

Unlike the FDA, the EMEA itself does not directly undertake appraisals of drug dossiers submitted to support marketing authorization applications under the centralized procedure. Instead (as discussed in detail below), they forward the dossier to selected national EU regulatory bodies, who undertake the appraisal, and the EMEA makes a recommendation to approve (or not) the application based upon the national body s report. The overall role of the EMEA is thus to coordinate and manage the new system. The EMEA s annual budget is of the order of 120 million. The key objectives of the EMEA may be summarized as ... 

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