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The basic legal and organizational framework for nuclear regulation in the USA has already been described in 1.4.4. The following section includes a basic description of the structure and responsibilities of the US Nuclear Regulatory Commission (NRC). The Commission’s organization chart is set forth in Fig. 11. Organizational structure of the NRC The NRC is headed by a Commission comprising 5 members, each appointed by the President of the USA and confirmed by the US Senate. Several measures have been adopted to ensure the Commission’s independent, non-partisan character. Commissioners serve for fixed five year terms and can only be removed for legal cause (e.g., violation of law or dereliction of duty). The Chairman of the Commission is designated by the President from among the Commissioners and serves in that capacity at the discretion of the President. Although the Chairman has some special responsibilities regarding management of the agency, each Commission possesses and equal vote on policy matters. If removed as Chairman, the person may remain on the Commission for the remainder of his or her term of office. One of the commissioners’ terms expires each year, providing a regular rotation of membership. Commissioners may be re-appointed. However, to avoid partisanship, no more than three of the five commissioners can be members of a single political party. A few years ago, the NRC was somewhat restructured along the lines of a corporate business model. In particular, two new officers were designated to manage major organizational functions. A Chief Information Officer (CIO) was designated to be responsible for all information technology, communication and computing capabilities. Similarly, a Chief Financial Officer (CFO) was designated to deal with resource and budget issues. The Executive Director for Operations (EDO) continues to be the Chief Operating Officer of the Agency. The EDO maintains management supervision over all NRC’s three main operating divisions - Materials, Research and State Programmes; Reactor Programmes; and Management Services. As indicated in the Fig. 8 organization chart, these three Divisions supervise the activities of the various NRC offices covering specific areas of the Agency’s responsibility. These cover all the traditional areas of regulatory supervision, including standard-setting, licensing, inspection and enforcement. A number of offices related to the Commission’s overall administrative functioning are directly supervised by the Commission, itself. Such offices include: Inspector General; Congressional Affairs; Public Affairs; General Counsel; and International Programmes. The Commission’s various advisory bodies (such as the Advisory Committees on Reactor Safeguard and on Waste) also report directly to the Commission. Consistent with the large size and geographic breadth of the US programme, the Commission has also established four regional offices (in Pennsylvania, Georgia, Illinois and Texas). These regional offices provide a direct link to state and local governments and individual installations through resident inspectors stationed at each nuclear power plant. The role of the Office of the Inspector General should be highlighted. This office is functionally independent of the Commission, issuing reports on how the agency conducts its business from the standpoint of efficiency, ethics and effectiveness. The office has a separate budget, approved by the Congress, to avoid any suggestion that the Commission is unduly influencing its reviews so that the Commission cannot limit its resources if it does not like the kind of reporting it is getting. As mentioned, the Commission has created two independent bodies to provide technical advice to the Commission. The Advisory Committee on Nuclear Waste and the Advisory Committee on Reactor Safeguards (meaning safety) are comprised of expert scientists and engineers. Law and regulations require that the views of these bodies be considered in the licensing process. Regulatory independence and the NRC Although it is difficult to define regulatory independence, the regulatory framework within which the NRC functions has been structured to insulate the Commission from outside influence in its decision making on issues affecting public health, safety, security and the environment. Key features of this framework are the following: Separation of functions: As an organization, NRC not only has no responsibility for promoting or developing nuclear energy, but - importantly - is completely separate from any other government bodies having such responsibilities. Political influence: As already noted, no more than three of the five commissioners can come from a single political party. In a country with two dominant political parties, this helps protect against partisanship, no matter how much control one party may have on other organs of government. Commissioners also serve relatively long (5 years) fixed terms, and may also only be removed for "cause" ( i.e., not because they have lost favor with the current political leadership. Conflicts of interest: The Commission implements very strict that prohibit the commissioners or any of the NRC staff from having a financial or personal interest in entities or subject that may be subject to their regulatory decisions. Transparency is important in this regard. NRC employment regulations require annual financial disclosure reports to ensure that improper relationships are identified and eliminated. Openness: The concept of transparency goes even further at the NRC. Several laws ensure that the commission’s decision-making process is conducting in public. For example, the Government in the Sunshine Act requires advance public notice of meetings, with a right of attendance by interested parties. The Freedom of Information Act requires broad public access to any materials used in the decision-making process. Reporting: An important guarantee of independence is NRC’s ability to provide extensive safety-related information to the public, media, other governmental bodies, without review or clearance from any other government agency. Budget and finance: The NRC covers essentially all of its budget through license fees, as authorized in an annual appropriations act by the Congress. This "full cost recovery" approach is believed to provide at least some insulation from political pressures that could result from having NRC’s resources derived entirely from tax revenues. Further, the NRC is entitled to submit its own budget to the Congress, subject only to review by the President’s Office of Management and Budget (OMB). Technical capabilities: For any agency responsible for regulating a complex technology, it is important to possess adequate scientific, engineering, management, financial and legal expertise. The NRC’s large staff (almost 3000 employees) reflects high technical competence and covers cover a wide range of technical areas. This provides important independence from the regulated industry in terms of assessing information provided by licensees. Oversight mechanisms: As final insurance against improper decision-making, the NRC system includes important oversight mechanisms. The internal - but independent - Office of Inspector General provides a scheduled review of NRC’s management. External oversight is exercised by the independent judiciary through appeals of NRC decisions to the federal courts. Congress also conducts oversight that can result in remedial action through legislation or appropriations. The eight elements outlined above do not guarantee absolute independence, a status that is both impossible to achieve and undesirable in principle. However, these elements are important in assuring that safety judgements are not subordinated to other interests - political, economic or social. This degree of independence helps maintain public confidence in the safe uses of nuclear energy, and indispensable prerequisite for its continued use. NRC implementation of main regulatory functions In the following is described in greater detail the manner in which the NRC implements its responsibilities in the main areas of regulatory activity: standard-setting or rulemaking, licensing, inspection, enforcement, regulatory research and public information. Standard-setting or rulemaking At the NRC, regulatory standards are issued through a process called rulemaking. The process is primarily initiated by the Commission’s technical staff, although any member of the public can propose that NRC develop, change, cancel or rescind any regulation. The Commission receives many such requests from environmental organizations and local organizations. NRC rulemaking is a very open process, with public participation a keystone. NRC cannot promulgate rules without giving the public an opportunity to make comments. Before a rule is even drafted, the NRC staff often holds public meetings or workshops to solicit views on a proposed rule. The preferred approach to rulemaking is to provide advance notice of a proposed rulemaking in the Federal Register (the daily federal publication that announces significant government actions). Such an advance notice of proposed rule making is short, typically about a page long; stating that the Commission is considering adopting a new rule or changing or cancelling an old one. Some considerations may also be included, with an indication of initial factors the NRC staff is considering as a basis for the rulemaking. A period of time (usually not less than 30 days) is provided for comment by stakeholders (i.e., industry, interest groups, the public). Emergency rules or minor rules may be issued without public comment, but that is exceptional. After receiving comments, the NRC staff develops the text of a proposed rule. This text is also placed in the Federal Register, for specific comment. Depending on the significance of the issue or on the comments received, the NRC will determine whether to conduct a public hearing on the proposed rule. After comments on the proposed rule are received and evaluated, and a hearing conducted or denied, a final rule (reflecting any changes considered appropriate) is published in the Federal Register. NRC rules are subject to challenge in the federal courts. As previously indicated, such appeals are typically based on whether the procedure followed in adopting the rule has complied with relevant legal requirements; not whether the NRC’s technical judgements are correct. The NRC has recently taken steps to make its rulemaking process even more open and efficient. The Commission has created a website "NRC Rulemaking Forum" giving advance notice to the public of rule making and providing a mechanism for receiving comments electronically. The NRC rulemaking process may appear protracted and cumbersome. However, it is consistent with the country’s traditions of open and democratic traditions decision making. It has also been found useful in creating a more stable regulatory system because Commission decisions are less likely to be challenged or overturned if NRC can demonstrate that the public has been involved fully and at every stage in establishing regulatory standards. For some years, NRC’s reactor licensing function has not been particularly active. The Commission has not received an application for a new nuclear power plant since the late 1970s. However, the Commission has used this period to streamline and update the licensing process. The traditional approach to licensing power reactors was a two step process, involving a separate Construction Permit (CP) and an Operating License (OL). This process is set forth in Part 50 of the Commission’s rules (in Title 10 of the Code of Federal Regulations (CFR)). Part 50 lists the extensive requirements such licenses. Extensive evaluation of the licensing process, urged by the nuclear industry and some in Congress, convinced the Commission that this two-step process was unnecessarily cumbersome and inefficient. As a result, the NRC adopted a streamlined, combined CP/OL licensing process that is set forth in Part 52 of the CFR. Under this approach, an applicant with a pre-approved site and approved design can obtain a single license permitting him to operate the plant. Part 52 details the requirements for site and design approvals. Even under the new Part 52, the reactor licensing process is lengthy and complex. The following summary identifies the major steps in the NRC process:
Even in the absence of applications for new nuclear power plants, the NRC has been confronted with important licensing issues. The first of these is license renewal. Nuclear plants in the USA were originally licensed for 40 years. A number of operating plants are now approaching the end of their license terms. This raises the issue of whether (and if so, for how long) they should be authorized to continue operating. With over one hundred operating reactors in the USA, the NRC anticipates a large number of requests for license renewal. The commission’s regulations in Part 54 of Title 10, Code of Federal Regulations, establish detailed safety requirements for license renewal. The NRC’s primary focus in it license renewal review is on so-called "passive" and "long-lived" structures and components (e.g., reactor vessel, reactor coolant pumps, piping, steam generators, pressurizer, valve bodies and pump casings). A must demonstrate that any ageing effects will not unacceptably effect the safety of the plant. License renewal also requires another environmental review, supplementing the original review, for the purpose of assuring that extended operation will not have unacceptable impacts. A second major licensing issue confronting the NRC is license transfer. Restructuring and deregulation of the electricity industry for economic reasons has accelerated in recent years in the USA. New companies are getting into the business of generating electricity, while other companies are leaving the business or merging into new legal entities. Where a new legal entity takes over an existing nuclear plant, continued operation will require a transfer of the current NRC operating license. For this to happen, the Commission must make a determination that the new operating organization has the technical, management and financial capabilities to operate the reactor safely. The third key regulatory function is inspection. NRC conducts a wide range of different types of inspections of nuclear reactors, fuel cycle facilities and other users of nuclear material. For nuclear reactors, the Commission inspection programme is primarily conducted through a system of resident inspectors. The Commission has assigned at least two resident inspectors to each site, with additional inspectors for sites with multiple reactors. Resident inspectors continually monitor licensee activities on the site, both obtaining and transmitting early information concerning plant conditions and facility events. The resident inspectors provide direct contact between NRC management and the licensee. They also evaluate what additional inspection activities may be needed that they are not competent to conduct themselves. Many of these special inspection activities are conducted from the NRC’s four regional offices and some from the Commission headquarters. Specialist inspectors from headquarters or regional offices typically cover such as radiation protection, instrumentation and control, earth sciences and fire safety. In terms of overall inspection effort, the NRC spends an average of approximately 3250 inspection hours (about 6 person-years) on each reactor annually. The NRC has also developed specific reactor inspection programmes for the major phases of nuclear power plant construction and operation, including: pre-construction activity, Construction Permit activity, pre-operational phase, start-up phase, operations phase and decommissioning phase. Outside the power reactor field, NRC also conducts approximately 1700 health and safety inspections of nuclear materials licensees annually. Qualification requirements for NRC inspectors include: a college degree in engineering or physical science, experience in the nuclear industry (except for interns), onsite inspection training, Qualification board and certification and periodic refresher training. The NRC provides an extensive training and certification programme for inspectors at its training center in Chattanooga, Tennessee. Much of the training is done through reactor simulators at the training center on full-scope simulators covering most major reactor designs used in the USA. Each NRC inspection is fully documented in a formal report that includes: scope of the inspection and conclusions on the effectiveness of the programme inspected, licensee management and quality assurance programme, strengths and weaknesses of the licensee, compliance with NRC requirements, findings to support conclusions and determinations on violations (generally dealt with in a separate enforcement proceeding). Finally, with regard to inspection, it should be noted that the NRC has recently implemented a new reactor oversight process utilizing a risk-informed, performance-based approach focusing on safety issues deemed of greatest importance. This approach aims at re-focusing inspection effort and reducing the burden to both regulators and operators by taking advantage of risk insights. Although it involves the entire range of regulatory activity, it is particularly relevant to the inspection and enforcement functions. This new approach is discussed in some detail in 6.3.1 - NRC’s risk-informed, performance-based assessment programme. The fourth key regulatory function is enforcement. The importance of the enforcement function is underlined by the fact that NRC maintains an office of enforcement that is separate from organizational bodies conducting regulatory inspections. Requiring inspectors to justify the need for enforcement action by another Commission body, is not only a check on over-zealous inspectors, but encourages full documentation of violations. The objectives of NRC enforcement action are to deter licensees from failing to comply with NRC regulatory requirements and to encourage licensees to promptly identify and to correct any violation of safety significance. Three types of enforcement actions are employed by the NRC: notice of violation, civil monetary penalties and orders to modify, suspend or revoke licenses. Violations are ranked by their significance from severity level I (most serious) to severity level IV (least serious). NRC considers four factors in determining the level of significance: actual safety consequences, the potential or future safety consequences, impact on NRC’s regulatory functions, intent of the violation (e.g., whether the licensee committed the violation deliberately or was merely careless, or did not understand the requirement). In applying its enforcement sanction, the Commission may consider civil monetary penalties for Level III violations (these are routinely used for Level I and II violations). The Atomic Energy Act authorizes the NRC to penalize a licensee up to 120 thousand dollars per day. A more severe sanction would be to close down a facility entirely, an action the NRC is also authorized to do in cases where the public health and safety may be at risk. The amount of a civil monetary penalty will depend on several factors, including: type of licensed activity, type of licensee, severity Level of the violation, whether the licensee has been the subject of significant enforcement action in the past two years or past two inspections, whether the licensee should receive credit for identifying the violation, whether the licensee has taken prompt and effective action to correct the violation, whether, in view of all the circumstances, discretion should be exercised with regard to the amount of the penalty. In 1999, the NRC assessed over a million dollars in civil penalties. The money obtained through NRC enforcement does not come directly to the Commission, but it goes to the US Treasury. For serious violations we do have criminal prosecution penalties. For serious, intentional or repeated violations, criminal penalties (e.g., imprisonment) may be applicable. In such cases - extremely rare - the NRC will refer the matter to the Department of Justice for further investigation and possible prosecution. Regulatory research NRC has a very substantial regulatory research programme. The Commission usually refers to its programme as confirmatory research to make clear that its purpose is to support its regulatory mission, not the development or promotion of nuclear energy. The programme has three main objectives: to provide independent information to support regulatory decision making, to assess the potential safety significance of technical issues, and to prepare the NRC to deal with future safety issues arising from new designs and technology. NRC’s research budget, which had averaged about $100 million annually, has been reduced to approximately $70 million in recent years due to government deficit reduction efforts and other circumstances. With more limited resources, current NRC research activities have focused on issues of greatest significance for nuclear safety, including: emerging technologies (e.g., digital instrumentation and control systems), plant ageing issues, decommissioning, operating experience, and risk-informed regulatory approaches. More limited resources have also encouraged the NRC to look for opportunities to conduct cooperative safety research with other nations in joint bilateral or multilateral projects. The NRC maintains a large cooperative programme with Japan, a joint project with Russia, and with other countries. Public information NRC considers public information one of its most important responsibilities. Public confidence in the safety of nuclear energy depends, to a great extent, on the openness and credibility of regulators. NRC maintains a separate Office of Public Affairs that reports directly to the Commission. Each of NRC’s four regional offices also maintains a public affairs office. As discussed earlier, a number of laws require the Commission (and all other US government agencies) to provide a broad range of information to the public, the legislative branch, and to the press and media. Examples of the wide-ranging materials made available by the Commission are provided in the next section of this section - NRC regulatory guidance. The NRC’s website (www.nrc.gov) provides access to this information in electronic form. Regulatory guidance The system through which the NRC provides regulatory guidance is extremely wide-ranging and diverse. It should be emphasized that this guidance is not directed solely to licensees. Of course, guidance is essential in achieving an effective regulator-operator interface. However, it is also important to recognize that the regulatory guidance has many stake-holders who seek to review this guidance and to utilize it for their purposes. Such stake-holders include: local and state governments having important roles in the regulatory process; other federal agencies; interest groups (i.e., local community groups, environmental organizations);the press and media; other nations; international organizations; and members of the general public. It should not be ignored that the primary consumers of regulatory guidance are NRCs own employees, who will be expected to conduct their responsibilities consistently with agency policies and standards. NRC guidance ranges from highly formal documents that are strictly binding on licensees and NRC staff, to less formal guidance on general Commission policy. This guidance is also multifunctional, ranging from organization and management procedures, through standards and technical specifications, to inspection and enforcement requirements. This guidance also covers many different subjects. An important feature of NRC’s guidance system is that virtually everything NRC produces as a guideline is publicly available, resulting in a highly transparent process. Finally, another important aspect of the NRC system is that it is a process in constant revision and reinvention. NRC guidance documents are continually reviewed, updated, changed and cancelled accordingly. Before discussing some of the most important examples of NRC regulatory guidance, it may be useful to have a general overview of the types of documentation developed and made available by the Commission. Table VII - Survey of USNRC guidance documents provides such an overview. Table VII. SURVEY OF US NRC GUIDANCE DOCUMENTS
It would not be either possible or useful to attempt to describe all of these documents. However, they can be easily accessed through the Internet, to provide a detailed picture of NRC’s regulatory approach. The legal pyramid of guidance documents As in most other nations, the legal pyramid in the USA is comprised of the fundamental law or constitution at the top, regular legislative acts or laws at the next lower level, regulations at a lower level still, with technical standards and regulatory guidance at the lowest level. For the USA, the top of the pyramid is occupied by the US Code Annotated, the official compilation of laws enacted by the Congress. To the extent that these laws sometimes adopt specific requirements that must be applied by the NRC, they could be considered a form of regulatory guidance. Code of Federal Regulations: However, the highest level of material that can be properly considered NRC guidance is probably the next lower level, which is occupied by the Code of Federal Regulations (CFR). The CFR comprises the regulatory enactments of all US Federal agencies. Title 10 of the CFR contains energy-related regulations, including those promulgated by the NRC. These regulations are promulgated through formal agency procedures, typically involving the requirement for public notice and opportunity to comment. Title 10 contains basic standards generally applicable to all NRC licensees, with a range of technical references. The Index to Title 10 is about 4 pages and lists all subjects in the CFR that pertain to the business of nuclear regulation. However, only a few parts of the CFR need special mention here. Examples of those particularly relevant to the regulation of the safety of nuclear reactors include:
NRC regulatory guides: An important category of NRC guidance is regulatory guides (see Table IV, number 2). These are designed to provide guidance to licensees and applicants on implementing specific NRC regulations. They explain the methodologies and techniques used by the staff in evaluating certain problems or accidents. They also provide specific data needed by the NRC staff in reviewing permits or licenses. They inform a licensee what he has to submit for the purpose of obtaining authorization to conduct a licensed activity. The regulatory guides fall within 10 divisions, as follows:
NRC inspection manual: Very important document is the NRC inspection manual that is primarily intended to guide NRC inspection staff in regulatory activity. However, it also provides guidance to licensees and public on how NRC conducts its work including procedural and organizational matters. The manual is an internal document, it is not subject to the level of outside review or public participation like the Code of Federal Regulations. NUREG Documents: Somewhat below the regulations and regulatory guides there are reports in a numbered series designed NUREG Documents. The series was begun very early in the history of the Atomic Energy Commission. NUREG Documents are technical reports on subject of broad interest. They are not regulations, nor even mandatory documents, but they provide important on technical subjects of broad interests. They also include directories, manuals, procedural guides for internal NRC use, as well as the proceedings of meetings or conferences on technical subjects. International agreements are also set forth in NUREG Documents. Generic environmental impact reports, which are general statements about the impact of certain kinds of nuclear activities on the environment that are used in the licensing process are also included in this series. Reports about contracts the NRC has negotiated with other organizations are a final category of NUREG. Generic communications: Because they do not fit in any other category, NRC has included a number of documents in a series called "Generic Communications". The category can include administrative letters to licensees about aspects of their work that are concerned to the Commission. The series also includes bulletins on technical or administrative matters, circulars, generic letters and similar documents (for example, those relating to a common mode problem in a reactor system). Information notices and regulatory issues summaries are also circulated to the public. These concise summaries describe the handling of regulatory issues of particular interest. Inspector General reports: The Inspector General issues annual and semi-annual reports on specific topics providing the reports of his investigations on NRC management practices to ensure efficiency, effectiveness and integrity. This is the important mechanism of the NRC’s internal quality assurance process. The Inspector General may also report on conduct by licensees where that conduct affect NRC regulatory programmes. Inspector General reports are read very carefully on the subject of great interest. Accessing NRC regulatory guidance documents: The first stopping point for anyone seeking a particular NRC guidance document is the agency’s website at www.nrc.gov. The site is a user-friendly clearing-house for the complete range of NRC documentation. In addition to the NRC website, another avenue for research into the Commission’s guidance documents has recently been developed. ADAMS is the acronym for NRC’s new automated data acquisition and management system, an information technology engine that puts every piece of paper in the NRC system into an electronic form that can be accessed by authorized persons. ADAMS will permit rapid access to every aspect of the NRC regulatory guidance system, enabling the Commission to communicate with its licensees, the public and other people.  FIG. 11. US Nuclear Regulatory Commission — organization |
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