Security practices and regulatory compliance in the healthcare industry.

Science.gov (United States)

Kwon, Juhee; Johnson, M Eric

2013-01-01

Securing protected health information is a critical responsibility of every healthcare organization. We explore information security practices and identify practice patterns that are associated with improved regulatory compliance. We employed Ward's cluster analysis using minimum variance based on the adoption of security practices. Variance between organizations was measured using dichotomous data indicating the presence or absence of each security practice. Using t tests, we identified the relationships between the clusters of security practices and their regulatory compliance. We utilized the results from the Kroll/Healthcare Information and Management Systems Society telephone-based survey of 250 US healthcare organizations including adoption status of security practices, breach incidents, and perceived compliance levels on Health Information Technology for Economic and Clinical Health, Health Insurance Portability and Accountability Act, Red Flags rules, Centers for Medicare and Medicaid Services, and state laws governing patient information security. Our analysis identified three clusters (which we call leaders, followers, and laggers) based on the variance of security practice patterns. The clusters have significant differences among non-technical practices rather than technical practices, and the highest level of compliance was associated with hospitals that employed a balanced approach between technical and non-technical practices (or between one-off and cultural practices). Hospitals in the highest level of compliance were significantly managing third parties' breaches and training. Audit practices were important to those who scored in the middle of the pack on compliance. Our results provide security practice benchmarks for healthcare administrators and can help policy makers in developing strategic and practical guidelines for practice adoption.

Waste management regulatory compliance issues related to D ampersand D activities at Oak Ridge National Laboratory (ORNL)

International Nuclear Information System (INIS)

Hitch, J.P.; Arnold, S.E.; Burwinkle, T.; Daugherty, D.

1994-01-01

The waste management activities at ORNL related to the decontamination and decommissioning (D ampersand D) of radioactively contaminated buildings are divided into four categories: Operational facilities, inactive or surplus facilities, future facilities planning, and D ampersand D activities. This paper only discusses regulatory issues related to inactive or surplus facilities. Additionally, rather than attempting to address all resulting waste streams and related regulations, this paper highlights only a few of the ORNL waste streams that present key regulatory issues

Methods for ensuring compliance with regulatory requirements: regulators and operators

International Nuclear Information System (INIS)

Fleischmann, A.W.

1989-01-01

Some of the methods of ensuring compliance with regulatory requirements contained in various radiation protection documents such as Regulations, ICRP Recommendations etc. are considered. These include radiation safety officers and radiation safety committees, personnel monitoring services, dissemination of information, inspection services and legislative power of enforcement. Difficulties in ensuring compliance include outmoded legislation, financial and personnel constraints

Regulatory compliance analysis for the closure of single-shell tanks

International Nuclear Information System (INIS)

Smith, E.H.; Boomer, K.D.; Letourneau, M.; Oakes, L.; Lorang, R.

1991-08-01

This document provides a regulatory compliance analysis of the baseline environmental protection requirements for the closure of single-shell tanks. In preparing this document, the Westinghouse Hanford Company has analyzed the regulatory pathways and decisions points that have been identified to data through systems engineering and related studies as they relate to environmental protection. This regulatory compliance analysis has resulted in several conclusions that will aid the US Department of Energy in managing the single-shell tank waste and in developing strategies for the closure of these tanks. These conclusions include likely outcomes of current strategies, regulatory rulings that are required for future actions, variances and exemptions to be pursued, where appropriate, and potential rulings that may affect systems engineering and other portions of the single-shell tank closure effort. The conclusions and recommendations presented here are based on analysis of current regulations, regulatory exemptions and variances, and federal facility agreements. Because the remediation of the single-shell tanks will span 30 years, regulations that have yet to be promulgated and future interpretations of existing laws and regulations may impact the recommendations and conclusions presented here. 50 refs., 22 figs

MO-AB-201-01: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223

Energy Technology Data Exchange (ETDEWEB)

Phillips, L. [Stanford University (United States)

2015-06-15

The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatory Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35

MO-AB-201-01: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223

International Nuclear Information System (INIS)

Phillips, L.

2015-01-01

The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatory Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35

Year 2000 compliance issues.

Science.gov (United States)

1999-03-01

This month, we continue our coverage of the year 2000 (Y2K) problem as it affects healthcare facilities and the professionals who work in them. We present the following articles: "Checking PCs for Y2K Compliance"--In this article, we describe the probable sources of Y2K-related errors in PCs and present simple procedures for testing the Y2K compliance of PCs and application software. "Y2K Assessment Equipment Expectations"--In this article, we review the Y2K compliance data from a small sampling of hospitals to help answer the question "What percentage of medical equipment will likely be susceptible to Y2K problems?" "Y2K Labeling of Medical Devices"--In this article, we discuss the pros and cons of instituting a program to label each medical device with its Y2K status. Also in this section, we present an updated list of organizations that support ECRI's Position Statement on the testing of medical devices for Y2K compliance, which we published in the December 1998 issue of Health Devices (27[12]). And we remind readers of the services ECRI can offer to help healthcare institutions cope with the Y2K problem.

Mobile Source Emissions Regulatory Compliance Data Inventory

Science.gov (United States)

The Mobile Source Emissions Regulatory Compliance Data Inventory data asset contains measured summary compliance information on light-duty, heavy-duty, and non-road engine manufacturers by model, as well as fee payment data required by Title II of the 1990 Amendments to the Clean Air Act, to certify engines for sale in the U.S. and collect compliance certification fees. Data submitted by manufacturers falls into 12 industries: Heavy Duty Compression Ignition, Marine Spark Ignition, Heavy Duty Spark Ignition, Marine Compression Ignition, Snowmobile, Motorcycle & ATV, Non-Road Compression Ignition, Non-Road Small Spark Ignition, Light-Duty, Evaporative Components, Non-Road Large Spark Ignition, and Locomotive. Title II also requires the collection of fees from manufacturers submitting for compliance certification. Manufacturers submit data on an annual basis, to document engine model changes for certification. Manufacturers also submit compliance information on already certified in-use vehicles randomly selected by the EPA (1) year into their life and (4) years into their life to ensure that emissions systems continue to function appropriately over time.The EPA performs targeted confirmatory tests on approximately 15% of vehicles submitted for certification. Confirmatory data on engines is associated with its corresponding submission data to verify the accuracy of manufacturer submission beyond standard business rules.Section 209 of the 1990 Amendments to the Clea

A waste package strategy for regulatory compliance

International Nuclear Information System (INIS)

Stahl, D.; Cloninger, M.O.

1990-01-01

This paper summarizes the strategy given in the Site Characterization Plan for demonstrating compliance with the post closure performance objectives for the waste package and the Engineered Barrier System contained in the Code of Federal Regulations. The strategy consists of the development of a conservative waste package design that will meet the regulatory requirements with sufficient margin for uncertainty using a multi-barrier approach that takes advantage of the unsaturated nature of the Yucca Mountain site. 7 refs., 1 fig

Validation of gamma irradiator controls for quality and regulatory compliance

International Nuclear Information System (INIS)

Harding, R.B.; Pinteric, F.J.A.

1995-01-01

Since 1978 the U.S. Food and Drug Administration (FDA) has had both the legal authority and the Current Good Manufacturing Practice (CGMP) regulations in place to require irradiator owners who process medical devices to produce evidence of Irradiation Process Validation. One of the key components of Irradiation Process Validation is the validation of the irradiator controls. However, it is only recently that FDA audits have focused on this component of the process validation. What is Irradiator Control System Validation? What constitutes evidence of control? How do owners obtain evidence? What is the irradiator supplier's role in validation? How does the ISO 9000 Quality Standard relate to the FDA's CGMP requirement for evidence of Control System Validation? This paper presents answers to these questions based on the recent experiences of Nordion's engineering and product management staff who have worked with several US-based irradiator owners. This topic - Validation of Irradiator Controls - is a significant regulatory compliance and operations issues within the irradiator suppliers' and users' community. (author)

Recent regulatory issues in Finland

International Nuclear Information System (INIS)

Laaksonen, J.; Tiipana, P.

2001-01-01

This paper presents general regulatory issues from Finland since the last WWER Regulators Forum meeting in Odessa 11-13 October 2000. More specific issues concerning Loviisa NPP are described in the Annex of this paper. (author)

Environmental Regulatory Compliance Plan for Site Characterization

International Nuclear Information System (INIS)

1988-12-01

The DOE is committed to conduct its operations in an environmentally safe and sound manner, and will comply with applicable environmental statutes and regulations. These objectives are described in DOE Order 5400.1 (Environmental Protection Program Requirements). This document -- the Environmental Regulatory Compliance Plan (ERCP) -- is one method of implementing the policy set forth in DOE Order 5400.1 and the NWPA. The ERCP describes the plan by which the DOE will comply with applicable Federal environmental statutes and regulations. The ERCP also discusses how DOE will address State and local environmental statutes and regulations. 180 refs., 27 figs., 1 tab

Regulatory compliance for a Yucca Mountain Repository: A performance assessment perspective

International Nuclear Information System (INIS)

Dyer, J.R.; Van Luik, A.E.; Gil, A.V.; Brocoum, S.J.

1997-01-01

The U.S. Department of Energy's Yucca Mountain Site Characterization Project is scheduled to submit a License Application in the year 2002. The License Application is to show compliance with the regulations promulgated by the U.S. Nuclear Regulatory Commission which implement standards promulgated by the U.S. Environmental Protection Agency. These standards are being revised, and it is not certain what their exact nature will be in term of either the performance measure(s) or the time frames that are to be addressed. This paper provides some insights pertaining to this regulatory history, an update on Yucca Mountain performance assessments, and a Yucca Mountain Site Characterization Project perspective on proper standards based on Project experience in performance assessment for its proposed Yucca Mountain Repository system. The Project's performance assessment based perspective on a proper standard applicable to Yucca Mountain may be summarized as follows: a proper standard should be straight forward and understandable; should be consistent with other standards and regulations; and should require a degree of proof that is scientifically supportable in a licensing setting. A proper standard should have several attributes: (1) propose a reasonable risk level as its basis, whatever the quantitative performance measure is chosen to be, (2) state a definite regulatory time frame for showing compliance with quantitative requirements, (3) explicitly recognize that the compliance calculations are not predictions of actual future risks, (4) define the biosphere to which risk needs to be calculated in such a way as to constrain potentially endless speculation about future societies and future human actions, and (5) have as its only quantitative requirement the risk limit (or surrogate performance measure keyed to risk) for the total system

Emissions trading and compliance: Regulatory incentives and barriers

International Nuclear Information System (INIS)

South, D.W.; Bailey, K.A.; McDermott, K.A.

1992-01-01

The Title IV of the Clean Air Act Amendments of 1990 (P.L. 101-549) authorizes the use of transferable emission allowances to achieve reductions in the power generating industry's SO 2 emissions at a minimum possible cost. All electricity generators (greater than 25 MW) are required to hold emissions allowances equal to the amount (tons) of SO 2 emitted during a given year, and meet NO x reduction levels indicated by the Revised New Source Performance Standards (NSPS). This paper will examine the multifaceted goals and problems of states and utilities relative to compliance with Title IV, and in particular as they pertain to the development and functioning of the allowance market together with utility pollution control and power generation technology choice. Section 2 presents possible utility compliance strategies along with possible barriers that utilities may confront regarding the development of a SO 2 allowance market. Section 3 discusses current regulatory barriers and requirements being implemented by state public utility commissions, and Section 4 offers some policy recommendations to achieve the goals of Title IV. Finally, Section 5 presents a summary and conclusions; Appendix A provides programs/mandates developed to data by high sulfur coal states in response to Title IV compliance requirements

Regulatory compliance issues related to the White Oak Creek Embayment time-critical removal action

International Nuclear Information System (INIS)

Leslie, M.; Kimmel, B.L.

1992-01-01

In September 1990, Martin Marietta Energy Systems (Energy Systems) discovered high levels of Cesium-137 present in surface sediments at the mouth of White Oak Creek (WOC) Embayment. WOC receives the majority of surface water drainage from Oak Ridge National Laboratory. Following this discovery, the Department of Energy (DOE) and Energy Systems pursued stabilizing sediment migration under provisions of the National Contingency Plan (NCP) Section 300.400 et. seq. as a time-critical removal action. However, significant uncertainty exists concerning the applicability of NCP procedural requirements designed for conducting US EPA-led, Superfund-financed response actions, because NCP Subpart K dealing with response actions at federal facilities has not been promulgated. In addition, relatively new guidance exists from DOE concerning National Environmental Policy Act documentation requirements for categorical exclusions associated with conducting removal actions at DOE facilities. A proactive approach was taken to identify issues and involve appropriate state and federal regulatory agencies. This approach required achieving consensus among all involved parties and identification of all applicable or relevant and appropriate regulatory requirements related to the removal action. As a result, this project forms a framework for conducting future time-critical removal actions at federal facilities

Integration of Environmental Compliance at the Savannah River Site - 13024

International Nuclear Information System (INIS)

Hoel, David; Griffith, Michael

2013-01-01

The Savannah River Site (SRS) is a large federal installation hosting diverse missions and multiple organizations with competing regulatory needs. Accordingly, there was a need to integrate environmental compliance strategies to ensure the consistent flow of information between Department of Energy-Savannah River (DOE-SR), the regulatory agencies and other interested parties. In order to meet this objective, DOE and major SRS contractors and tenants have committed to a strategy of collaboratively working together to ensure that a consistent, integrated, and fully coordinated approach to environmental compliance and regulator relationships is maintained. DOE-SR and Savannah River Nuclear Solutions, LLC, the SRS management and operations contractor, have established an environmental compliance integration process that provides for the consistent flow down of requirements to projects, facilities, SRS contractors, and subcontractors as well as the upward flow of information to assist in the early identification and resolution of environmental regulatory issues and enhancement of compliance opportunities. In addition, this process strongly fosters teamwork to collaboratively resolve complex regulatory challenges, promote pollution prevention and waste minimization opportunities to advance site missions in a manner that balances near-term actions with the long-term site vision, while being protective of human health and the environment. Communication tools are being utilized, some with enhancements, to ensure appropriate information is communicated to all levels with environmental responsibility at SRS. SRS internal regulatory integration is accomplished through a variety of informational exchange forums (e.g., Challenges, Opportunities and Resolution (COR) Team, DOE's Joint Site Regulatory Integration Team, and the Senior Environmental Managers Council (SEMC)). SRS communications and problem-solving with the regulatory agencies have been enhanced through formation of an

Integration of Environmental Compliance at the Savannah River Site - 13024

Energy Technology Data Exchange (ETDEWEB)

Hoel, David [United States Department of Energy - Savannah River Operations Office (United States); Griffith, Michael [Savannah River Nuclear Solutions, LLC (United States)

2013-07-01

The Savannah River Site (SRS) is a large federal installation hosting diverse missions and multiple organizations with competing regulatory needs. Accordingly, there was a need to integrate environmental compliance strategies to ensure the consistent flow of information between Department of Energy-Savannah River (DOE-SR), the regulatory agencies and other interested parties. In order to meet this objective, DOE and major SRS contractors and tenants have committed to a strategy of collaboratively working together to ensure that a consistent, integrated, and fully coordinated approach to environmental compliance and regulator relationships is maintained. DOE-SR and Savannah River Nuclear Solutions, LLC, the SRS management and operations contractor, have established an environmental compliance integration process that provides for the consistent flow down of requirements to projects, facilities, SRS contractors, and subcontractors as well as the upward flow of information to assist in the early identification and resolution of environmental regulatory issues and enhancement of compliance opportunities. In addition, this process strongly fosters teamwork to collaboratively resolve complex regulatory challenges, promote pollution prevention and waste minimization opportunities to advance site missions in a manner that balances near-term actions with the long-term site vision, while being protective of human health and the environment. Communication tools are being utilized, some with enhancements, to ensure appropriate information is communicated to all levels with environmental responsibility at SRS. SRS internal regulatory integration is accomplished through a variety of informational exchange forums (e.g., Challenges, Opportunities and Resolution (COR) Team, DOE's Joint Site Regulatory Integration Team, and the Senior Environmental Managers Council (SEMC)). SRS communications and problem-solving with the regulatory agencies have been enhanced through formation

Regulatory compliance issues related to the White Oak Creek Embayment time-critical removal action

International Nuclear Information System (INIS)

Leslie, M.; Kimmel, B.L.

1991-01-01

In September 1990, Martin Marietta Energy Systems (Energy Systems) discovered high levels of Cesium-137 ( 137 Cs) in surface sedimenus near the mouth of White Oak Creek Embayment (WOCE). White Oak Creek (WOC) receives surface water drainage from Oak Ridge National Laboratory. Since this discovery, the Department of Energy (DOE) and Energy Systems have pursued actions designed to stabilize the contaminated WOCE sediments under provisions of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), and the implementing regulations in the National Contingency Plan (NCP) (40 CFR Part 300), as a time-critical removal action. By definition, a time-critical removal is an action where onsite activities are initiated within six months of the determination that a removal action is appropriate. Time-critical removal actions allow comparatively rapid mobilization to protect human health and the environment without going through the lengthy and extensive CERCLA Remedial Investigation/Feasibility Study/Record of Decision process. Many aspects of the project, in terms of compliance with the substantive requirements of the NCP and ARARs, have exceeded the regulatory requirements, despite the fact that there is no apparent authority on conducting removal actions at Federal facilities. Much of the interpretation of the NCP was groundbreaking in nature for both EPA and DOE. 4 refs., 2 figs

Waste package for Yucca Mountain repository: Strategy for regulatory compliance

International Nuclear Information System (INIS)

Cloninger, M.; Short, D.; Stahl, D.

1989-02-01

This document summarizes the strategy given in the Site Characterization Plan (1) for demonstrating compliance with the post closure performance objectives for the waste package and the Engineered Barrier System (EBS) contained in the Code of Federal Regulations. The strategy consists of the development of a conservative waste package design that will meet the regulatory requirements with sufficient margin for uncertainty using a multi-barrier approach that takes advantage of the unsaturated nature of the Yucca Mountain site. This strategy involves an iterative process designed to achieve compliance with the requirements for substantially complete containment and EBS release. The strategy will be implemented in such a manner that sufficient evidence will be provided for presentation to the Nuclear Regulatory Commission (NRC) so that it may make a finding that there is ''reasonable assurance'' that these performance requirements will indeed be met. In implementing the strategy, DOE recognizes four fundamental goals: (1) protect public health and safety; (2) minimize financial and other resource commitments; (3) comply with applicable laws and regulations; and (4) maintain an aggressive schedule. The strategy is intended to be a reasonable balance of these competing goals. 7 refs., 3 figs., 1 tab

Environmental protection and regulatory compliance at the Elk Hills field

International Nuclear Information System (INIS)

Chappelle, H.H.; Donahoe, R.L.; Kato, T.T.; Ordway, H.E.

1991-01-01

Environmental protection has played an integral role in the development and operation of the Elk Hills field since production at the maximum efficient rate was authorized in 1976. The field is located in a non-attainment area for California and National Ambient Air Quality Standards for two criteria pollutants and their associated precursors, is home to four endangered species, and operates within the California regulatory framework. Environmental protection and regulatory compliance is a multi-faceted program carried out through a substantial commitment of resources and workforce involvement. This paper describes the actions taken and resources employed to protect the environment, specific technologies and projects implemented, and the ongoing nature of these efforts at Elk Hills

Meeting the regulatory information needs of users of radioactive materials

International Nuclear Information System (INIS)

MacDurmon, G.W.

1996-01-01

The use of radioactive materials is one of the most regulated areas of research. Researchers face ever increasing regulatory requirements and issues involving the disposal of radioactive material, while meeting the demands of higher productivity. Radiation safety programs must maximize regulatory compliance, minimize barriers, provide services and solutions, and effectively communicate with users of radioactive materials. This talk will discuss methods by which a radiation safety program can meet the needs of both the research staff and regulatory compliance staff

Meeting the regulatory information needs of users of radioactive materials

Energy Technology Data Exchange (ETDEWEB)

MacDurmon, G.W. [American Cyanamid Company, Princeton, NJ (United States)

1996-10-01

The use of radioactive materials is one of the most regulated areas of research. Researchers face ever increasing regulatory requirements and issues involving the disposal of radioactive material, while meeting the demands of higher productivity. Radiation safety programs must maximize regulatory compliance, minimize barriers, provide services and solutions, and effectively communicate with users of radioactive materials. This talk will discuss methods by which a radiation safety program can meet the needs of both the research staff and regulatory compliance staff.

Regulatory Enforcement and Compliance

DEFF Research Database (Denmark)

May, Peter J.; Winter, Søren

1999-01-01

This study of municipal enforcement of agro-environmental regulations in Denmark provides an empirical understanding of how enforcement affects compliance. A key contribution is sorting out the relative influence of inspectors' different styles of enforcement and choices made by enforcement...... agencies. The latter are shown to be more important in bringing about compliance than are inspectors' enforcement styles. Municipal agencies are shown to increase compliance through the use of third parties, more frequent inspection, and setting priorities for inspection of major items. The findings about...

Regulatory issues for nuclear power plant life management

International Nuclear Information System (INIS)

Roe, J.

2000-01-01

The workshop of 26-27 june 2000, on nuclear power Plant LIfe Management (PLIM), also included working groups in which major issues facing PLIM activities for nuclear power plants were identified and discussed. The second group was on Regulation. The Regulatory Working Group will attempt to identify some of the more pertinent issues affecting nuclear plant regulation in a changing PLIM environment, to identify some possible actions to be taken to address these issues, and to identify some of the parties responsible for taking these actions. Some preliminary regulatory issues are noted below. This is not intended to be a comprehensive list of such issues but rather is intended to stimulate discussion among the experts attending this Workshop. One of the concerns in the regulatory arena is how the structural integrity of the plants can be assured for an extended lifetime. Technological advances directed toward the following are likely to be important factors in the regulatory process of life extension. - Preventive and corrective maintenance (e.g., water chemistry control, pressure vessel annealing, and replacement of core internals). - Ageing and degradation mechanisms and evaluation (e.g., embrittlement, wear, corrosion/erosion, fatigue, and stress corrosion). - Monitoring, surveillance, and inspection (e.g., fatigue monitoring and non-destructive testing). - Optimisation of maintenance (e.g., using risk-based analysis). On the business side, there is concern about technical support by manufacturers, fuel companies, and construction companies. Maintaining a strong technical base and skilled workers in a potentially declining environment is another concern in the regulatory community. Waste management and decommissioning remain significant issue regarding PLIM. These issues affect all three areas of concern - technology, business, and regulation. It is against this background, that the issues put forth in this paper are presented. The objective of presenting these

An approach to regulatory compliance with radioactive mixed waste regulations

International Nuclear Information System (INIS)

Baker, G.G.; Mihalovich, G.S.; Provencher, R.B.

1991-01-01

On May 7, 1990, radioactive mixed waste (RMW) at the West Valley Demonstration Project (WVDP) became subject to the State Of New York hazardous waste regulations. The facility was required to be in full compliance by June 6, 1990. Achievement of this goal was difficult because of the short implementation time frame. Compliance with the hazardous waste regulations also presented some potential conflicts between the hazardous waste requirements and other regulatory requirements specifically applicable to nuclear facilities. The potential conflicts involved construction, operation, and control measures. However, the facility had been working extensively with EPA Region 2 and the New York State Department of Environmental Conservation (NYSDEC) on the application of the hazardous waste regulations to the facility. During these preliminary contacts, WVDP identified three issues that related to the potential conflicts: 1. Equivalency of Design and Equipment, 2. Land Disposal Restrictions (LDR), and 3. The Principle of As Low As Reasonable Achievable (ALARA) Radiation Exposure. The equivalency of nuclear facility design and equipment to the hazardous waste requirements is based in part on the increased construction criteria for nuclear facilities, the use of remote radiological monitoring for leak detection, and testing of system components that are not accessible to personnel due to high levels of radiation. This paper discusses in detail: 1. The implementation and results of the WVDP's interaction with its regulators, 2. How the regulators were helped to understand the different situations and conditions of nuclear and chemical facilities, and 3. How, by working together, the result was not only mutually advantageous to the NWDP and the agencies, but it also assured that the health and safety of workers, the public, and the environment were protected

Regulatory guidance document

International Nuclear Information System (INIS)

1994-05-01

The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM's evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7

Regulatory issues and assumptions associated with polymers for subsurface barriers surrounding buried waste

International Nuclear Information System (INIS)

Heiser, J.; Siskind, B.

1993-01-01

One of the options for control of contaminant migration from buried waste sites is the construction of a subsurface barrier that consists of a wall of low permeability material. Subsurface barriers will improve remediation performance by removing pathways for contaminant transport due to groundwater movement, meteorological water infiltration, vapor- and gas-phase transport, transpiration, etc. Subsurface barriers may be used to open-quotes directclose quotes contaminant movement to collection sumps/lysimeters in cases of unexpected remediation failures or transport mechanisms, to contain leakage from underground storage tanks, and to restrict in-situ soil cleanup operation and chemicals. Brookhaven National Laboratory is currently investigating advanced polymer materials for subsurface barriers. This report addresses the regulatory aspects of using of non-traditional polymer materials as well as soil-bentonite or cement-bentonite mixtures for such barriers. The regulatory issues fall into two categories. The first category consists of issues associated with the acceptability of subsurface barriers to the Environmental Protection Agency (EPA) as a method for achieving waste site performance improvement. The second category encompasses those regulatory issues concerning health, safety and the environment which must be addressed regarding barrier installation and performance, especially if non-traditional materials are to be used. Since many of EPA's concerns regarding subsurface barriers focus on the chemicals used during installation of these barriers the authors discuss the results of a search of the Federal Register and the Code of Federal Regulations for references in Titles 29 and 40 pertaining to key chemicals likely to be utilized in installing non-traditional barrier materials. The use of polymeric materials in the construction industry has been accomplished with full compliance with the applicable health, safety, and environmental regulations

Legal and regulatory issues affecting compressed air energy storage

Energy Technology Data Exchange (ETDEWEB)

Hendrickson, P.L.

1981-07-01

Several regulatory and legal issues that can potentially affect implementation of a compressed air energy storage (CAES) system are discussed. This technology involves the compression of air using base load electric power for storage in an underground storage medium. The air is subsequently released and allowed to pass through a turbine to generate electricity during periods of peak demand. The storage media considered most feasible are a mined hard rock cavern, a solution-mined cavern in a salt deposit, and a porous geologic formation (normally an aquifer) of suitable structure. The issues are discussed in four categories: regulatory issues common to most CAES facilities regardless of storage medium, regulatory issues applicable to particular CAES reservoir media, issues related to possible liability from CAES operations, and issues related to acquisition of appropriate property rights for CAES implementation. The focus is on selected federal regulation. Lesser attention is given to state and local regulation. (WHK)

Regulatory inspection of nuclear facilities and enforcement by the regulatory body. Safety guide

International Nuclear Information System (INIS)

2002-01-01

The purpose of this Safety Guide is to provide recommendations for regulatory bodies on the inspection of nuclear facilities, regulatory enforcement and related matters. The objective is to provide the regulatory body with a high level of confidence that operators have the processes in place to ensure compliance and that they do comply with legal requirements, including meeting the safety objectives and requirements of the regulatory body. However, in the event of non-compliance, the regulatory body should take appropriate enforcement action. This Safety Guide covers regulatory inspection and enforcement in relation to nuclear facilities such as: enrichment and fuel manufacturing plants; nuclear power plants; other reactors such as research reactors and critical assemblies; spent fuel reprocessing plants; and facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Section 2 sets out the objectives of regulatory inspection and enforcement. Section 3 covers the management of regulatory inspections. Section 4 covers the performance of regulatory inspections, including internal guidance, planning and preparation, methods of inspection and reports of inspections. Section 5 deals with regulatory enforcement actions. Section 6 covers the assessment of regulatory inspections and enforcement activities. The Appendix provides further details on inspection areas for nuclear facilities

Achievement of process control, safety, and regulatory compliance in a mixed waste evaporator system at the Hanford Site using data quality objectives

International Nuclear Information System (INIS)

Von Bargen, B.H.

1995-01-01

The Data Quality Objectives (DQO) Process was applied to the operation of the 242-A Evaporator at the Hanford Site. A team consisting of representatives from process engineering, environmental engineering, regulatory compliance, analytical laboratories, and DOE utilized the step by step DQO process to define the issues, variables, and inputs necessary to develop the decision rules which govern plant operations. The sampling and analyses required to make these decisions was then optimized concerning factors such as sample number, total analyses, cost, radiation exposure, quality assurance, and deliverables

Legal, privacy, security, access and regulatory issues in cloud computing

CSIR Research Space (South Africa)

Dlodlo, N

2011-04-01

Full Text Available a gap on reporting are on are legal , privacy, security, access and regulatory issues. This paper raises an awareness of legal, privacy, security, access and regulatory issues that are associated with the advent of cloud computing. An in...

Relationship between regulatory issues and probabilistic risk assessments

International Nuclear Information System (INIS)

Ilberg, D.; Papazoglou, I.

1985-01-01

The objective of this study was to obtain some perspective on the characteristics and the relative number of regulatory issues that are PRA related, i.e., can be effectively addressed by plant specific PRA studies. It was also aimed at developing approaches to resolution of regulatory issues as part of plant specific PRAs. Several ongoing NRC programs include a number of safety-related issues which are applicable to operating plants. A number of these issues include aspects that strongly interact with items addressed in PRA studies. The resolution of several generic issues using PRA studies has already started. A review of over 335 issues included in three NRC programs was conducted: Generic Issue Program (GI); Systematic Evaluation Program (SEP); and TMI Action Plan (TMI). The review identifid 240 items related to PRA, 120 of which were judged to have significant effect on core damage frequency. It is believed that these items can be effectively treated in a PRA study that includes internal and external events

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).

Science.gov (United States)

Dufield, Dawn; Neubert, Hendrik; Garofolo, Fabio; Kirkovsky, Leo; Stevenson, Lauren; Dumont, Isabelle; Kaur, Surinder; Xu, Keyang; Alley, Stephen C; Szapacs, Matthew; Arnold, Mark; Bansal, Surendra; Haidar, Sam; Welink, Jan; Le Blaye, Olivier; Wakelin-Smith, Jason; Whale, Emma; Ishii-Watabe, Akiko; Bustard, Mark; Katori, Noriko; Amaravadi, Lakshmi; Aubry, Anne-Françoise; Beaver, Chris; Bergeron, Annik; Cai, Xiao-Yan; Cojocaru, Laura; DeSilva, Binodh; Duggan, Jeff; Fluhler, Eric; Gorovits, Boris; Gupta, Swati; Hayes, Roger; Ho, Stacy; Ingelse, Benno; King, Lindsay; Lévesque, Ann; Lowes, Steve; Ma, Mark; Musuku, Adrien; Myler, Heather; Olah, Timothy; Patel, Shefali; Rose, Mark; Schultz, Gary; Smeraglia, John; Swanson, Steven; Torri, Albert; Vazvaei, Faye; Wilson, Amanda; Woolf, Eric; Xue, Li; Yang, Tong-Yuan

2014-01-01

The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion in the evolving field of bioanalysis, took place in Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations and regulatory agencies worldwide convened to share, review, discuss and agree on approaches to address current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches and immunogenicity. From the prolific discussions held during the workshop, specific recommendations are presented in this 2014 White Paper. As with the previous years' editions, this paper acts as a practical tool to help the bioanalytical community continue advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2014 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations for Hybrid LBA/LCMS, Electronic Laboratory Notebook and Regulatory Agencies' Input. Part 1 (Small molecules bioanalysis using LCMS) was published in the Bioanalysis issue 6(22) and Part 3 (Large molecules bioanalysis using LBA and Immunogenicity) will be published in the Bioanalysis issue 6(24).

ENRICH Forum: Ethical aNd Regulatory Issues in Cancer ResearcH

Science.gov (United States)

ENRICH Forum: Ethical aNd Regulatory Issues in Cancer ResearcH, designed to stimulate dialogue on ethical and regulatory issues in cancer research and promote awareness of developing policies and best practices.

Key Past and Present Hydrologic Issues at the Waste Isolation Pilot Plant (WIPP)

International Nuclear Information System (INIS)

Lappin, Allen R.; McKenna, Sean A.; Davies, Peter B.

2000-01-01

In May 1998, the U.S; Environmental Protection Agency (EPA) certified the U.S. Department of Energy's (DOE) Waste Isolation Pilot Plant (WIPP) to be in compliance with applicable portions of regulations governing the permanent disposal of radioactive wastes. The step was accomplished after 24 years of effort by Sandia National Laboratories, extending from initial site selection, through extensive site characterization and under-ground experimentalization to evaluation and demonstration of regulatory compliance. The strong focus on regulatory compliance extended over approximately five years, culminating in DOE's submittal of a Compliance Certification Application (CCA) in October, 1996. Specific lessons learned from the WIPP'S transition from site characterization/experimental research to a successful regulatory compliance application may be of general interest to participants in other repository problems. In summary, the three examples considered in this paper indicate that: It is critical that site-characterization and performance-assessment (PA) activities in a repository project advance through multiple iterative interactions. This is because there are parallel paths of evolution-within a projecy On one hand, there is a natural development in the conceptual understanding of the site and repository geology, hydrology, and geochemistry over time, as well as a normal increase in the roles of regulatory/safety issues relative to technical issues. On the other hand there is ongoing evolution in numerical-modeling, experimental, and PA techniques, as well as in understanding of the insights gained from these activities. However, even if conceptual models do not change, the modeling and documentation techniques and detailed logic supporting these models will change; as additional relevant information is collected within or outside the project. Some issues related to general site-characterization or site-suitability will remain of interest, even after initial

Monitoring compliance with requirements during site characterization

International Nuclear Information System (INIS)

Herrington, C.C.; Jennetta, A.R.; Dobson, D.C.

1991-01-01

The question of when a program of Regulatory Compliance should be applied and what it should be applied to, when the subject of compliance is a High Level Radioactive Waste Repository, defies resolution by merely relating to past practices of licensees of the US Nuclear Regulatory Commission (NRC). NRC regulations governing the disposal of High Level Waste include interactions with the potential applicant (US DOE) during the pre-license application phase of the program when the basis for regulatory compliance is not well defined. To offset this shortcoming, the DOE will establish an expanded basis for regulatory compliance, keeping the NRC apprised of the basis as it develops. As a result, the preapplication activities of DOE will assume the added benefit of qualification to a suitable Regulatory Compliance monitoring and maintenance plan

Security issues of new innovative payments and their regulatory challenges

NARCIS (Netherlands)

Kasiyanto, Safari; Gabriella, Gimigliano

2016-01-01

Kasiyanto discusses how the security issues of M-payments and Bitcoin as new forms of innovative payments challenge the existing EU regulatory frameworks, and whether the proposed regulatory frameworks suffice to address such challenges. The regulatory frameworks Kasiyanto discusses mainly focus on

Regulatory issues for deep borehole plutonium disposition

International Nuclear Information System (INIS)

Halsey, W.G.

1995-03-01

As a result of recent changes throughout the world, a substantial inventory of excess separated plutonium is expected to result from dismantlement of US nuclear weapons. The safe and secure management and eventual disposition of this plutonium, and of a similar inventory in Russia, is a high priority. A variety of options (both interim and permanent) are under consideration to manage this material. The permanent solutions can be categorized into two broad groups: direct disposal and utilization. The deep borehole disposition concept involves placing excess plutonium deep into old stable rock formations with little free water present. Issues of concern include the regulatory, statutory and policy status of such a facility, the availability of sites with desirable characteristics and the technologies required for drilling deep holes, characterizing them, emplacing excess plutonium and sealing the holes. This white paper discusses the regulatory issues. Regulatory issues concerning construction, operation and decommissioning of the surface facility do not appear to be controversial, with existing regulations providing adequate coverage. It is in the areas of siting, licensing and long term environmental protection that current regulations may be inappropriate. This is because many current regulations are by intent or by default specific to waste forms, facilities or missions significantly different from deep borehole disposition of excess weapons usable fissile material. It is expected that custom regulations can be evolved in the context of this mission

Compliance as process: Work safety in the Chinese construction industry

NARCIS (Netherlands)

Li, Na

2016-01-01

China is facing a key challenge of achieving compliance in many regulatory areas. Responding to such issue, this research reports on an exploratory empirical study of how the regulated construction businesses comply with work safety rules in China. Building on the existing literature, it develops a

Mobile Source Emissions Regulatory Compliance Data

Data.gov (United States)

U.S. Environmental Protection Agency — The Engine and Vehicle Compliance Certification and Fuel Economy Inventory contains measured emissions and fuel economy compliance information for all types of...

Environmental radioactivity studies and regulatory issues

International Nuclear Information System (INIS)

Abalkina, I.L.; Sarkisov, A.A.; Linge, I.I.; Kazakov, S.V.; Panchenko, S.V.; Savelieva, E.A.

2008-01-01

During the last decades, Russia has developed regulations applying to the territories affected by radioactive contamination. Some regulatory approaches appear to be quite ineffective and contradictory. This paper shows by means of examples the problems and issues associated with some existing situations. A better way for the future is indicated

Regulatory issues associated with the Multi-Purpose (MPC) system

International Nuclear Information System (INIS)

Roberts, J.P.; Desell, L.J.; Birch, M.L.; Morgan, R.G.

1994-01-01

The US Department of Energy Office of Civilian Radioactive Waste Management is developing a Multi-Purpose Canister system to promote compatibility between the waste program elements of storage, transportation, and disposal. The development of a Multi-Purpose Canister system requires meeting various regulatory requirements. These regulatory requirements are set forth in environmental and Nuclear Regulatory Commission (NRC) regulations. This paper discusses the more significant regulatory issues that must be addressed in the development of a Multi-Purpose Canister system by the Department of Energy

Regulatory issues in merchant transmission investment

International Nuclear Information System (INIS)

Brunekreeft, G.

2005-01-01

Merchant investment in electricity transmission networks (MTI) is now legally allowed. Predominantly driven by the fear of underinvestment, regulators examine this possibility and given that MTI is a possibility, the regulators face a new set of questions. This paper raises and examines regulatory questions especially from a European institutional framework. The regulatory issues concern the competition effect, the ownership, access regime and the must-offer provision. The paper argues to leave light-handed unregulated MTI light handed and refrain from additional measures. In most cases, it is justified to refrain from sector-specific arrangements because competition,law, if necessary at all, will suffice. However, details matter. (author)

Scrubbers: A popular Phase I compliance strategy

International Nuclear Information System (INIS)

Fink, C.E.; Bissell, P.E.; Koch, B.J.; Rutledge, G.D.

1992-01-01

As utilities commit to compliance plans to meet the Phase I requirements of the Clean Air Act Amendments of 1990, there are indications that scrubbing may account for up to 50 percent of the total SO 2 reductions in Phase I. This paper presents and analyzes the critical reasons that explain how and why scrubber-based compliance strategies have developed into the least-cost option in Phase I for many utilities. A hypothetical utility system was simulated to study the impacts of various technological, legislative, and regulatory issues on compliance decisions and costs. Issues evaluated using the hypothetical system include the emissions cap, Clean Air Act and state incentives to scrub, improvements in scrubber technology and costs, and the integration of Phase I and II compliance strategies by the phased installation of scrubbers. In combination, these considerations increase the attractiveness of scrubbers during the 1995-1999 Phase I period. Other considerations that will ultimately influence the amount of Phase I scrubbing capacity include the additional power generation costs associated with fuel switching, the uncertainty of low-sulfur coal price projections, fuel supply flexibility, scrubber market aspects, and socioeconomic considerations

Wetland restoration and compliance issues on the Savannah River site

International Nuclear Information System (INIS)

Wein, G.R.; McLeod, K.W.; Sharitz, R.R.

1993-01-01

Operation of the nuclear production reactors on the Savannah River Site has faced potential conflicts with wetland regulations on several occasions. This paper provides two examples in which regulatory compliance and restoration research have been meshed, providing both compliance and better knowledge to aid future regulatory needs. The decision to restart the L reactor required the mitigation of thermal effluents under Sec. 316 of the Clean Water Act. The National Pollutant Discharge Elimination System, permit for the selected mitigation alternative, a 405-ha once-through cooling reservoir, required the establishment of a balanced biological community (BBC) within the lake. To promote the development of a BBC, the reservoir was seeded with water from an existing BBC (Par Pond) and stocked with fish and had artificial reefs constructed. The US Department of Energy (DOE) also requested that the Savannah River Ecology Laboratory establish littoral/wetland vegetation along the shoreline to provide aquatic and wildlife habitat, shoreline stabilization, and a good faith effort toward the establishment of a BBC. The development of wetland vegetation was deemed important to the successful development of a BBC within L Lake. However, in a similar cooling reservoir system constructed in 1957 (Par Pond), wetland vegetation successfully developed without any planting effort. Other than the good faith effort toward a BBC, there is no reason to assume a littoral/wetland community would not develop of its own accord. However, research conducted at L Lake indicates that the planting of wetland vegetation at L Lake accelerated the process of natural selection over that of areas that were not planted

78 FR 6316 - Enterprise Texas Pipeline LLC; Notice of Compliance Filing

Science.gov (United States)

2013-01-30

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR13-23-000] Enterprise Texas Pipeline LLC; Notice of Compliance Filing Take notice that on January 17, 2013, Enterprise Texas Pipeline LLC filed a revised Statement of Operating Conditions to comply with a Commission order issued in...

A simplified ALARA approach to demonstration of compliance with surface contaminated object regulatory requirements

International Nuclear Information System (INIS)

Pope, R.B.; Shappert, L.B.; Michelhaugh, R.D.; Boyle, R.W.; Cook, J.C.

1998-02-01

The US Department of Transportation (DOT) and the US Nuclear Regulatory Commission (NRC) have jointly prepared a comprehensive set of draft guidance for consignors and inspectors to use when applying the newly imposed regulatory requirements for low specific activity (LSA) material and surface contaminated objects (SCOs). The guidance is being developed to facilitate compliance with the new LSA material and SCO requirements, not to impose additional requirements. These new requirements represent, in some areas, significant departures from the manner in which packaging and transportation of these materials and objects were previously controlled. On occasion, it may be appropriate to use conservative approaches to demonstrate compliance with some of the requirements, ensuring that personnel are not exposed to radiation at unnecessary levels, so that exposures are kept as low as reasonably achievable (ALARA). In the draft guidance, one such approach would assist consignors preparing a shipment of a large number of SCOs in demonstrating compliance without unnecessarily exposing personnel. In applying this approach, users need to demonstrate that four conditions are met. These four conditions are used to categorize non-activated, contaminated objects as SCO-2. It is expected that, by applying this approach, it will be possible to categorize a large number of small contaminated objects as SCO-2 without the need for detailed, quantitative measurements of fixed, accessible contamination, or of total (fixed and non-fixed) contamination on inaccessible surfaces. The method, which is based upon reasoned argument coupled with limited measurements and the application of a sum of fractions rule, is described and examples of its use are provided

75 FR 27028 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

Science.gov (United States)

2010-05-13

... regulatory issues and their potential impact on investors and the securities markets. The Committee will lend... SECURITIES AND EXCHANGE COMMISSION [Release No. 33-9123; File No. 265-26] COMMODITY FUTURES TRADING COMMISSION Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues AGENCY: Securities and...

Regulatory Issues Surrounding Merchant Interconnection

International Nuclear Information System (INIS)

Kuijlaars, Kees-Jan; Zwart, Gijsbert

2003-11-01

We discussed various issues concerning the regulatory perspective on private investment in interconnectors. One might claim that leaving investment in transmission infrastructure to competing market parties is more efficient than relying on regulated investment only (especially in the case of long (DC) lines connecting previously unconnected parts of the grids, so that externalities from e.g. loop flows do not play a significant role). We considered that some aspects of interconnection might reduce these market benefits. In particular, the large fixed costs of interconnection construction may lead to significant under investment (due to both first mover monopoly power and the fact that part of generation cost efficiencies realised by interconnection are not captured by the investor itself, and remain external to the investment decision). Second, merchant ownership restricts future opportunities for adaptation of regulation, as would be required e.g. for introduction of potentially more sophisticated methods of congestion management or market splitting. Some of the disadvantages of merchant investment may be mitigated however by a suitable regulatory framework, and we discussed some views in this direction. The issues we discussed are not intended to give a complete framework, and detailed regulation will certainly involve many more specific requirements. Areas we did not touch upon include e.g. the treatment of deep connection costs, rules for operation and maintenance of the line, and impact on availability of capacity on other interconnections

Regulatory Issues Surrounding Merchant Interconnection

Energy Technology Data Exchange (ETDEWEB)

Kuijlaars, Kees-Jan; Zwart, Gijsbert [Office for Energy Regulation (DTe), The Hague (Netherlands)

2003-11-01

We discussed various issues concerning the regulatory perspective on private investment in interconnectors. One might claim that leaving investment in transmission infrastructure to competing market parties is more efficient than relying on regulated investment only (especially in the case of long (DC) lines connecting previously unconnected parts of the grids, so that externalities from e.g. loop flows do not play a significant role). We considered that some aspects of interconnection might reduce these market benefits. In particular, the large fixed costs of interconnection construction may lead to significant under investment (due to both first mover monopoly power and the fact that part of generation cost efficiencies realised by interconnection are not captured by the investor itself, and remain external to the investment decision). Second, merchant ownership restricts future opportunities for adaptation of regulation, as would be required e.g. for introduction of potentially more sophisticated methods of congestion management or market splitting. Some of the disadvantages of merchant investment may be mitigated however by a suitable regulatory framework, and we discussed some views in this direction. The issues we discussed are not intended to give a complete framework, and detailed regulation will certainly involve many more specific requirements. Areas we did not touch upon include e.g. the treatment of deep connection costs, rules for operation and maintenance of the line, and impact on availability of capacity on other interconnections.

Compliance Issues in Higher Education

Science.gov (United States)

Benedek, Petra

2016-01-01

Efficiency in the 1980's, quality in the 1990's, compliance in the 2010's - private sector management techniques and mechanisms find their way to public services. This paper facilitates the understanding of how compliance management controls can improve operations and prevent or detect failure or wrong doing. The last few years' empirical research…

Regulatory analyses for severe accident issues: an example

International Nuclear Information System (INIS)

Burke, R.P.; Strip, D.R.; Aldrich, D.C.

1984-09-01

This report presents the results of an effort to develop a regulatory analysis methodology and presentation format to provide information for regulatory decision-making related to severe accident issues. Insights and conclusions gained from an example analysis are presented. The example analysis draws upon information generated in several previous and current NRC research programs (the Severe Accident Risk Reduction Program (SARRP), Accident Sequence Evaluation Program (ASEP), Value-Impact Handbook, Economic Risk Analyses, and studies of Vented Containment Systems and Alternative Decay Heat Removal Systems) to perform preliminary value-impact analyses on the installation of either a vented containment system or an alternative decay heat removal system at the Peach Bottom No. 2 plant. The results presented in this report are first-cut estimates, and are presented only for illustrative purposes in the context of this document. This study should serve to focus discussion on issues relating to the type of information, the appropriate level of detail, and the presentation format which would make a regulatory analysis most useful in the decisionmaking process

The practical outfall of DOE compliance agreements

International Nuclear Information System (INIS)

Smith, Leanne; Henrie, Gregory O.

1992-01-01

Perhaps the significant regulatory issue facing the Department of Energy (DOE or the Department) is the compliant treatment, storage, and disposal of mixed (radioactive and hazardous) waste. Since DOE'S By-Product Rulemaking in 1987, when the Department acknowledged that the Resource Conservation and Recovery Act (RCRA) applied to the hazardous component of mixed waste, DOE has repeatedly communicated to the Environmental Protection Agency (EPA) and host States that, for mixed waste, DOE is not always able to strictly comply with RCRA standards and that bringing treatment on-line in an expeditious manner is proving very difficult. One of the most effective methods used between DOE and its regulators to address mixed waste management issues is the negotiation of compliance agreements. These agreements establish formal mile stones for bringing DOE sites into compliance. The milestones are not completed without overcoming technical roadblocks and a struggle for funding. However, agreements can establish technically attainable compliance methods that take into account the special problems radiation introduces into RCRA waste management. Compliance agreements help promote a cooperative relationship within the Department and between DOE and its regulators in that all parties have reached agreement and have a stake in attaining the same goal. Where agreements exist, mixed waste compliance efforts can proceed in a situation where all parties have a full understanding of each other's needs and expectations. (author)

Future water table rise at Yucca Mountain: A regulatory perspective

International Nuclear Information System (INIS)

Coleman, N.M.

1995-01-01

The U.S. Nuclear Regulatory Commission staff has developed a program of Systematic Regulatory Analysis (SRA). The purpose of this program is to ensure that important technical issues related to compliance with 10 CFR Part 60 will be identified before receipt of a license application. A plan is being developed to review the U.S. Department of Energy's (DOE's) demonstration of compliance in the license application for each part of the regulation. Under the siting criteria of NRC's Part 60, one of the potentially adverse conditions is the possibility that the water table may rise high enough to saturate a repository in the unsaturated zone. DOE must evaluate this and other conditions in a license application for a geologic repository site. DOE's evaluation must show compliance with the requirements of Part 60 with reasonable assurance. This paper describes the NRC staff's preliminary plans to review DOE's demonstration of compliance, including assumptions about a future rise of the water table

Regulatory issues in accreditation of toxicology laboratories.

Science.gov (United States)

Bissell, Michael G

2012-09-01

Clinical toxicology laboratories and forensic toxicology laboratories operate in a highly regulated environment. This article outlines major US legal/regulatory issues and requirements relevant to accreditation of toxicology laboratories (state and local regulations are not covered in any depth). The most fundamental regulatory distinction involves the purposes for which the laboratory operates: clinical versus nonclinical. The applicable regulations and the requirements and options for operations depend most basically on this consideration, with clinical toxicology laboratories being directly subject to federal law including mandated options for accreditation and forensic toxicology laboratories being subject to degrees of voluntary or state government–required accreditation.

Commentary: Compliance education and training: a need for new responses in clinical research.

Science.gov (United States)

Steinberg, Mindy J; Rubin, Elaine R

2010-03-01

Increasing regulatory mandates, heightened concerns about compliance, accountability, and liability, as well as a movement toward organizational integration are prompting assessment and transformation in education and training programs at academic health centers, particularly with regard to clinical research compliance. Whereas education and training have become a major link between all research and compliance functions, the infrastructure to support and sustain these activities has not been examined in any systematic, comprehensive fashion, leaving many critical interrelated issues unaddressed. Through a series of informal interviews in late 2008 with chief compliance officers and other senior leadership at 10 academic health centers, the authors studied the organization, management, and administration of clinical research compliance education and training programs. The interviews revealed that while clinical research compliance education and training are undergoing growth and expansion to accommodate a rapidly changing regulatory environment and research paradigm, there are no strategies or models for development. The decentralization of education and training is having serious consequences for leadership, resources, and effectiveness. The authors recommend that leaders of academic health centers conduct a comprehensive analysis of clinical research compliance education and training as clinical trials administration undergoes change, focusing on strategic planning, communication, collaboration across the institution, and program evaluation.

Overview of Variable Renewable Energy Regulatory Issues: A Clean Energy Regulators Initiative Report

Energy Technology Data Exchange (ETDEWEB)

Miller, M.; Cox, S.

2014-05-01

This CERI report aims to provide an introductory overview of key regulatory issues associated with the deployment of renewable energy -- particularly variable renewable energy (VRE) sources such wind and solar power. The report draws upon the research and experiences from various international contexts, and identifies key ideas that have emerged from the growing body of VRE deployment experience and regulatory knowledge. The report assumes basic familiarity with regulatory concepts, and although it is not written for a technical audience, directs the reader to further reading when available. VRE deployment generates various regulatory issues: substantive, procedural, and public interest issues, and the report aims to provide an empirical and technical grounding for all three types of questions as appropriate.

Enhancing regulatory effectiveness by improving the process for identifying and resolving generic issues

International Nuclear Information System (INIS)

Vander Molen, Harold J.

2001-01-01

The Generic Issues Program first began formally in response to a Commission directive in October of 1976. In 1983, it became one of the first programs to make successful use of probabilistic risk information to aid in regulatory decision-making. In the 16 years since the program became quantitative, 836 issues have been processed. Of these, 106 reactor safety issues were prioritized as requiring further evaluation to determine the final resolution. Approximately a dozen generic issues remain unresolved. Although there is far less reactor licensing activity than in the 1970s, new issues continue to be identified from research and operational experience. These issues often involve complex and controversial questions of safety and regulation, and an efficient and effective means of addressing these issues is essential for regulatory effectiveness. Issues that involve a significant safety question require swift, effective, enforceable, and cost-effective regulatory actions. Issues that are of little safety significance must be quickly shown to be so and dismissed in an expeditious manner so as to avoid unnecessary expenditure of limited resources and to reduce regulatory uncertainty. Additionally, in the time since the generic issue program began, probabilistic risk assessment techniques have advanced significantly while agency resources have continued to diminish. Accordingly, the paper discusses the steps that have been taken to enhance the effectiveness and efficiency of the generic issue resolution process. Additionally, four resolved issues are discussed, along with key elements of a proposed new procedure for resolving potential generic issues

30 CFR 773.11 - Review of compliance history.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

Critical scientific issues in the demonstration of WIPP compliance with EPA repository standards

International Nuclear Information System (INIS)

Weart, W.D.; Chu, M.S.Y.

1997-01-01

The Department of Energy submitted a Compliance Certification Application for the Waste Isolation Pilot Plant to the Environmental Protection Agency (EPA) in October, 1996. A critical part of this application was a Performance Assessment which predicts the cumulative radioactive release to the accessible environment over a time period of 10,000 years. Comparison of this predicted release to the EPA standard shows a comfortable margin of compliance. The scientific understanding that was critical to developing this assessment spans a broad range of geotechnical disciplines, and required a thorough understanding of the site's geology and hydrology. Evaluation of the geologic processes which are active in the site region establishes that there will be no natural breach of site integrity for millions of years, far longer than the 10,000 year regulatory period. Inadvertent human intrusion is, therefore, the only credible scenario to lead to potential radioactive release to the accessible environment. To substantiate this conclusion and to quantify these potential releases from human intrusion, it has been necessary to develop an understanding of the following processes: (1) salt creep and shaft seal efficacy; (2) gas generation from organic decomposition of waste materials and anoxic corrosion of metals in the waste and waste packages; (3) solubilities for actinides in brine; (4) fluid flow in Salado formation rocks, and (5) hydrologic transport of actinides in the overlying dolomite aquifers. Other issues which had to be evaluated to allow definition of breach scenarios were brine reservoir occurrences and their associated reservoir parameters, consequences of mining over the repository, and drilling for natural resources in the vicinity of the repository. Results of all these studies will be briefly summarized in this paper

Compliance status report for the Waste Isolation Pilot Plant

Energy Technology Data Exchange (ETDEWEB)

1994-03-31

The US Department of Energy (DOE) is responsible for the disposition of transuranic (TRU) waste generated through national defense-related activities. Approximately 53,700 m{sup 2} of these wastes have been generated and are currently stored at government defense installations across the country. The Waste Isolation Pilot Plant (WIPP), located in southeastern New Mexico, has been sited and constructed to meet the criteria established by the scientific and regulatory community for the safe, long-term disposal of TRU and TRU-mixed wastes. This Compliance Status Report (CSR) provides an assessment of the progress of the WIPP Program toward compliance with long-term disposal regulations, set forth in Title 40 CFR 191 (EPA, 1993a), Subparts B and C, and Title 40 CFR {section}268.6 (EPA, 1993b), in order to focus on-going and future experimental and engineering activities. The CSR attempts to identify issues associated with the performance of the WIPP as a long-term repository and to focus on the resolution of these issues. This report will serve as a tool to focus project resources on the areas necessary to ensure complete, accurate, and timely submittal of the compliance application. This document is not intended to constitute a statement of compliance or a demonstration of compliance.

Elements to evaluate the intention in the non-compliance s or violations to the regulatory framework in the national nuclear facilities

International Nuclear Information System (INIS)

Espinosa V, J. M.; Gonzalez V, J. A.

2013-10-01

Inside the impact evaluation process to the safety of non-compliance s or violations, developed and implanted by the Comision Nacional de Seguridad Nuclear y Salvaguardias (CNSNS), the Guide for the Impact Evaluation to the Safety in the National Nuclear Facilities by Non-compliance s or Violations to the Regulatory Framework was developed, which indicates that in the determination of the severity (graveness level) of a non-compliance or violation, four factors are evaluated: real and potential consequences to the safety, the impact to the regulator process and the intention. The non-compliance s or intentional violations are of particular interest, since the development of the regulatory activities of the CNSNS considers that the personnel of the licensees, as well as their contractors, will act and will communicate with integrity and honesty. The CNSNS cannot tolerate intentional non-compliance s, for what this violations type can be considered of a level of more graveness that the subjacent non-compliance. To determine the severity of a violation that involves intention, the CNSNS also took in consideration factors as the position and the personnel's responsibilities involved in the violation, the graveness level of the non-compliance in itself, the offender's intention and the possible gain that would produce the non-compliance, if exists, either economic or of another nature. The CNSNS hopes the licensees take significant corrective actions in response to non-compliance s or intentional violations, these corrective actions should correspond to the violation graveness with the purpose of generating a dissuasive effect in the organizations of the licensees. The present article involves the legal framework that confers the CNSNS the attributions to impose administrative sanctions to its licensees, establishes the definition of the CNSNS about what constitutes a non-compliance or intentional violation and finally indicates the intention types (deliberate or

Environmental Compliance for Oil and Gas Exploration and Production

Energy Technology Data Exchange (ETDEWEB)

Hansen, Christine

1999-10-26

The Appalachian/Illinois Basin Directors is a group devoted to increasing communication among the state oil and gas regulatory agencies within the Appalachian and Illinois Basin producing region. The group is comprised of representatives from the oil and gas regulatory agencies from states in the basin (Attachment A). The directors met to discuss regulatory issues common to the area, organize workshops and seminars to meet the training needs of agencies dealing with the uniqueness of their producing region and perform other business pertinent to this area of oil and gas producing states. The emphasis of the coordinated work was a wide range of topics related to environmental compliance for natural gas and oil exploration and production.

A study on the implement of regulatory issue problems about service business

International Nuclear Information System (INIS)

Kim, In Hwan; Shim, H. S.; Yoon, K. H.; Jun, I. Y.; Kang, W. S.; Chang, J. H.

2004-12-01

This study is intended to derive a proposal for revision of the Atomic Energy Law, with understanding of differences between regulatory requirements and current issues based on findings during safety review and regular inspection. The contents and scope of this study is as follows: - Deep review for service business in 'the rationalization of the radiation protection system related with use of radionuclide', studied by Korea Isotope Association and presentation in the Korea Association for radiation protection, - Efficient regulatory activity through pre-finding of current regulatory issues to be derived during safety review and regular inspection

Ratemaking and accounting for allowances and compliance costs

International Nuclear Information System (INIS)

Anon.

1992-01-01

The regulatory treatment of compliance costs and allowances will significantly affect both the utility's CAAA compliance decisions and the cost of compliance. Sections in this chapter include ratemaking treatment of allowances, utility buy-ins, the market test of compliance costs and utility incentive, FERC account classification, measuring the value of allowances, inventory methods for allowances, expense recognition of allowances, regulatory-created assets and liabilities, and application of the FERC proposal. 8 refs., 1 tab

Regulatory issues resolved through design certification on the System 80+trademark standard plant design

International Nuclear Information System (INIS)

Ritterbusch, S.E.; Brinkman, C.B.

1996-01-01

The US Nuclear Regulatory Commission (NRC) has completed its review of the System 80+trademark Standard Plant Design, approving advanced design features and closing severe accident licensing issues. Final Design Approval was granted in July 1994. The NRC review was extensive, requiring written responses to over 4,950 questions and formal printing of over 50,000 Safety Analysis Report pages. New safety issues never before addressed in a regulatory atmosphere had to be resolved with detailed analysis and evaluation of design features. the System 80+ review demonstrated that regulatory issues can be firmly resolved only through presentation of a detailed design and completion of a comprehensive regulatory review

U.S. NRC's generic issues program

International Nuclear Information System (INIS)

Kauffman, J.V.; Foster, J.W.

2008-01-01

The United States Nuclear Regulatory Commission (NRC) has a Generic Issues Program (GIP) to address Generic Issues (GI). A GI is defined as 'a regulatory matter involving the design, construction, operation, or decommissioning of several, or a class of, NRC licensees or certificate holders that is not sufficiently addressed by existing rules, guidance, or programs'. This rather legalistic definition has several practical corollaries: First, a GI must involve safety. Second, the issue must involve at least two plants, or it would be a plant-specific issue rather than a GI. Third, the potential safety question must not be covered by existing regulations and guidance (compliance). Thus, the effect of a GI is to potentially change the body of regulations and associated guidance (e.g., regulatory guides). The GIP was started in 1976, thus it is a relatively mature program. Approximately 850 issues have been processed by the program to date. More importantly, even after 30 years, new GIs continue to be proposed. The entire set of Generic Issues (GIs) is updated annually in NUREG-0933, 'A Prioritization of Generic Safety Issues'. GIs normally involve complex questions of safety and regulation. Efficient and effective means of addressing these issues are very important for regulatory effectiveness. If an issue proves to pose a genuine, significant safety question, then swift, effective, enforceable, and cost-effective action needs to be taken. Conversely, if an issue is of little safety significance, the issue should be dismissed in an expeditious manner, avoiding unnecessary expenditure of resources and regulatory burden or uncertainty. This paper provides a summary of the 5-stage program, from identification through the regulatory assessment stage. The paper also includes a discussion of the program's seven criteria, sources of proposed GIs, recent improvements, publicly available information, historical performance, and status of current GIs. (authors)

Regulatory controls for NORM contamination: Emerging issues and strategies

International Nuclear Information System (INIS)

Wennerberg, Linda

1992-01-01

Naturally occurring and accelerator-produced radioactive material (NORM) faces the increasing likelihood of federal or state regulatory control. Public concern and limited preliminary survey data fuel the debate over the necessity, approach, and jurisdiction of a NORM regulatory strategy. This debate requires the resolution of technical controversies and potentially competing state and federal agency interests. An additional facet of the debate is the impact of regulation upon traditionally non-nuclear industries, such as oil and gas production. Regulatory response has been initiated in several states, such as Louisiana's controls on equipment used in oil and gas production, to control specific industrial activities which generate NORM. A more comprehensive, generic federal strategy to control NORM contamination is also under review by the Environmental Protection Agency. This paper will detail the emerging technical issues, federal and state regulatory strategies under consideration, and evaluate the efficacy of selected regulatory approaches. (author)

Accelerators: radiation safety and regulatory compliance

International Nuclear Information System (INIS)

Bandyopadhyay, Tapas

2013-01-01

Growth of accelerators, both positive ions and electron, is very high in India. This may be because of the wide acceptance of these machines in the industrial purposes, medical uses, material science studies, upcoming ADSS facility and many other reasons. Most of cases for societal uses, accelerators have to be installed in the dense public domain. Accelerators for basic research and development purposes to be installed may in public domain or in isolated site. These accelerators are to be classified into different categories in terms of regulatory compliance. Radiation shield design, HVAC system required to be in place with design so that the dose and effluent discharge in the public domain is within a limit considering different pathways. INDUS I and II at Indore, K-130 and K500 machine at VECC, Pelletron at TIFR, IUAC, BARC, EBC at Mumbai are in operation. Apart from this accelerators, a series of medical accelerators in operation and yet to be operational which are generally producing PET isotopes for the diagnosis purposes. VECC is aiming to operate 30 MeV proton machine with about 500 μA beam current for the production of PET, SPECT isotopes for diagnosis purposes and also therapeutic use in near future. Detail requirement in terms of choice of sites, source term estimation for achieving optimum shield thickness, ventilation system, site layout and planning , radioactive effluent handling both gaseous and liquid, decommission aspects will be discussed. (author)

Directory of certificates of compliance for radioactive materials packages: Certificates of compliance

International Nuclear Information System (INIS)

1987-11-01

This directory contains a Summary Report of the US Nuclear Regulatory Commission's Certificates of Compliance (Volume 2) for Radioactive Material Packages effective October 1, 1987. This directory makes available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the back of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2

Environmental regulatory compliance plan, Deaf County site, Texas: Draft revision 1

International Nuclear Information System (INIS)

1987-01-01

The DOE is committed to conduct its operation in an environmentally safe and sound manner and comply with the letter and spirit of applicable environmental statues and regulations. These objectives are codified in DOE order N 5400.2, ''Environmental Policy Statement.'' This document, the Deaf Smith County site (Texas) Environmental Regulatory Compliance Plam (ERCP), is one means of implementing that policy. The ERCP describes the environmental regulatory requirements applicable to the Deaf Smith County site (Texas), and presented the framework within which the Salt Repository Project Office (SRPO) will comply with the requirements. The plan also discusses how DOE will address State and local environmental requirements. To achieve this purpose the ERCP will be developed in phases. This version of the ERCP is the first phase in the delopment of the ERCP. It represents the Salt Repository Project Office's understanding of environmental requirements for the site characterization phase of repository development. After consultation with the appropriate federal and state agencies and affected Indian tribes, the ERCP will be updated to reflect the results of consultation with these agencies and affected Indian tribes. 6 refs., 38 figs

Foreign capital, forest change and regulatory compliance in Congo Basin forests

International Nuclear Information System (INIS)

Brandt, Jodi S; Nolte, Christoph; Agrawal, Arun; Steinberg, Jessica

2014-01-01

Tropical forest change is driven by demand in distant markets. Equally, investments in tropical forest landscapes by capital originating from distant emerging economies are on the rise. Understanding how forest outcomes vary by investment source is therefore becoming increasingly important. We empirically evaluate the relationship between investment source and deforestation from 2000 to 2010 in the Republic of Congo. A Congolese forestry code was implemented in 2000 to mitigate degradation of production forests by standardizing all logging in the country according to sustainable forest management (SFM) guidelines. Following the implementation of this law, the majority (73%) of Congo’s production forests were managed by European (40%) and Asian (33%) companies. European concessions had the highest rates of total and core deforestation, followed by Asian concessions, indicating that the fragmentation of intact forests in Congo is strongly associated with industrial logging fueled by foreign capital. European concession holders were also far more likely to comply with SFM policies, followed by Asian concessions, suggesting that compliance with Sustainable Forest Management policies may not mitigate degradation in tropical production forests. Further evaluation of the relationship between investment source, regulatory compliance, and outcomes in tropical countries is essential for effective conservation of tropical forest ecosystems. (paper)

Foreign capital, forest change and regulatory compliance in Congo Basin forests

Science.gov (United States)

Brandt, Jodi S.; Nolte, Christoph; Steinberg, Jessica; Agrawal, Arun

2014-04-01

Tropical forest change is driven by demand in distant markets. Equally, investments in tropical forest landscapes by capital originating from distant emerging economies are on the rise. Understanding how forest outcomes vary by investment source is therefore becoming increasingly important. We empirically evaluate the relationship between investment source and deforestation from 2000 to 2010 in the Republic of Congo. A Congolese forestry code was implemented in 2000 to mitigate degradation of production forests by standardizing all logging in the country according to sustainable forest management (SFM) guidelines. Following the implementation of this law, the majority (73%) of Congo’s production forests were managed by European (40%) and Asian (33%) companies. European concessions had the highest rates of total and core deforestation, followed by Asian concessions, indicating that the fragmentation of intact forests in Congo is strongly associated with industrial logging fueled by foreign capital. European concession holders were also far more likely to comply with SFM policies, followed by Asian concessions, suggesting that compliance with Sustainable Forest Management policies may not mitigate degradation in tropical production forests. Further evaluation of the relationship between investment source, regulatory compliance, and outcomes in tropical countries is essential for effective conservation of tropical forest ecosystems.

On-farm welfare assessment for regulatory purposes: Issues and possible solutions

DEFF Research Database (Denmark)

Sørensen, Jan Tind; Fraser, David

2010-01-01

On-farm welfare assessment has been used mainly for non-regulatory purposes such as producer education or to qualify for voluntary welfare-assurance programs. The application of on-farm assessments in regulatory programs would require four issues to be addressed: (1) selecting criteria...... solution. Issues 3 and 4 (fairness and efficiency) require scientific data on the precision, repeatability, independence, and cost-of-scoring for the various candidate criteria. A process is also needed to bring the scientific information into the deliberative process, either as formal recommendations and...

76 FR 10072 - Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX, Adequacy of Station...

Science.gov (United States)

2011-02-23

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0013] Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX, Adequacy of Station Electric Distribution System Voltages; Reopening of... (NRC's) Draft Regulatory Issue Summary 2011-XX, Adequacy of Station Electric Distribution System...

Information security policy development for compliance

CERN Document Server

Williams, Barry L

2013-01-01

Although compliance standards can be helpful guides to writing comprehensive security policies, many of the standards state the same requirements in slightly different ways. Information Security Policy Development for Compliance: ISO/IEC 27001, NIST SP 800-53, HIPAA Standard, PCI DSS V2.0, and AUP V5.0 provides a simplified way to write policies that meet the major regulatory requirements, without having to manually look up each and every control. Explaining how to write policy statements that address multiple compliance standards and regulatory requirements, the book will he

Key Regulatory Issues for Digital Instrumentation and Control Systems at Nuclear Power Plants

International Nuclear Information System (INIS)

Korsah, Kofi; Wood, Richard Thomas

2008-01-01

To help reduce the uncertainty associated with application of digital instrumentation and controls (I and C) technology in nuclear power plants, the Nuclear Regulatory Commission (NRC) has issued six Interim Staff Guidance (ISG) documents that address the current regulatory positions on what are considered the significant digital I and C issues. These six documents address the following topics: Cyber Security, Diversity and Defense-in-Depth, Risk Informed Digital I and C Regulation, Communication issues, Human Factors and the Digital I and C Licensing Process (currently issued as Draft). After allowing for further refinement based on additional technical insight gathered by NRC staff through near-term research and detailed review of relevant experience, it is expected that updated positions ultimately will be incorporated into regulatory guides and staff review procedures. This paper presents an overview of the guidance provided by the NRC-issued ISGs on key technology considerations (i.e., the first five documents above) for safety-related digital I and C systems.

Nuclear regulatory decision making

International Nuclear Information System (INIS)

Wieland, Patricia; Almeida, Ivan Pedro Salati de

2011-01-01

The scientific considerations upon which the nuclear regulations are based provide objective criteria for decisions on nuclear safety matters. However, the decisions that a regulatory agency takes go far beyond granting or not an operating license based on assessment of compliance. It may involve decisions about hiring experts or research, appeals, responses to other government agencies, international agreements, etc.. In all cases, top management of the regulatory agency should hear and decide the best balance between the benefits of regulatory action and undue risks and other associated impacts that may arise, including issues of credibility and reputation. The establishment of a decision framework based on well established principles and criteria ensures performance stability and consistency, preventing individual subjectivity. This article analyzes the challenges to the decision-making by regulatory agencies to ensure coherence and consistency in decisions, even in situations where there is uncertainty, lack of reliable information and even divergence of opinions among experts. The article explores the basic elements for a framework for regulatory decision-making. (author)

Stability Testing of Herbal Drugs: Challenges, Regulatory Compliance and Perspectives.

Science.gov (United States)

Bansal, Gulshan; Suthar, Nancy; Kaur, Jasmeen; Jain, Astha

2016-07-01

Stability testing is an important component of herbal drugs and products (HDPs) development process. Drugs regulatory agencies across the globe have recommended guidelines for the conduct of stability studies on HDPs, which require that stability data should be included in the product registration dossier. From the scientific viewpoint, numerous chemical constituents in an herbal drug are liable to varied chemical reactions under the influence of different conditions during its shelf life. These reactions can lead to altered chemical composition of HDP and consequently altered therapeutic profile. Many reports on stability testing of HDPs have appeared in literature since the last 10 years. A review of these reports reveals that there is wide variability in temperature (-80 to 100 °C), humidity (0-100%) and duration (a few hours-36 months) for stability assessment of HDPs. Of these, only 1% studies are conducted in compliance with the regulatory guidelines for stability testing. The present review is aimed at compiling all stability testing reports, understanding key challenges in stability testing of HDPs and suggesting possible solutions for these. The key challenges are classified as chemical complexity and biochemical composition variability in raw material, selection of marker(s) and influences of enzymes. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

The Preliminary Review for the Cross-Cutting Issues in the US Nuclear Regulatory Inspection Framework

International Nuclear Information System (INIS)

Lee, Yong Suk; Jung, Dae Wook; Cho, Nam Chul

2008-01-01

The research for the development of risk-informed and performance-based regulatory inspection is ongoing in KINS. In the USNRC, the cross-cutting issue is one of the main components the risk-informed and performance-based regulatory inspection process as shown in figure 1, which is named as ROP (Reactor Oversight Process). The following three cross-cutting areas implicitly affect all of the safety cornerstones in ROP. In this study, the preliminary review for the inspection practices of cross-cutting issues in the US and Korean safety regulatory system were performed. The elements of the cross-cutting issues were recently modified to emphasize the importance of safety culture, and the graded approach was applied for the inspection of cross-cutting issues in USNRC. The graded approach for the inspection of cross-cutting issues will be also needed to Korean safety regulatory system in the future

The Preliminary Review for the Cross-Cutting Issues in the US Nuclear Regulatory Inspection Framework

Energy Technology Data Exchange (ETDEWEB)

Lee, Yong Suk; Jung, Dae Wook [Future and Challenges Inc., Seoul (Korea, Republic of); Cho, Nam Chul [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2008-10-15

The research for the development of risk-informed and performance-based regulatory inspection is ongoing in KINS. In the USNRC, the cross-cutting issue is one of the main components the risk-informed and performance-based regulatory inspection process as shown in figure 1, which is named as ROP (Reactor Oversight Process). The following three cross-cutting areas implicitly affect all of the safety cornerstones in ROP. In this study, the preliminary review for the inspection practices of cross-cutting issues in the US and Korean safety regulatory system were performed. The elements of the cross-cutting issues were recently modified to emphasize the importance of safety culture, and the graded approach was applied for the inspection of cross-cutting issues in USNRC. The graded approach for the inspection of cross-cutting issues will be also needed to Korean safety regulatory system in the future.

Session II-H. Regulatory implementation

International Nuclear Information System (INIS)

Farzin, M.H.

1981-01-01

During FY 1981, the program concepts for implementing the NRC and EPA regulations were formed. These concepts consist of: review and critique of proposed rules; interpretation of rules into practical performance objectives; and planning to achieve compliance of total system performance with the rules. Although still flexible because of the lack of final rules, notable advances in implementation of these concepts were achieved in FY 1981. Technically, proposed and draft rules were evaluated and resulting radionuclide release limits were compared for consistency. For issue identification and resolution activity, six LTR's were initiated, and other topics were identified. In activities leading to total system compliance with regulations, planning and implementation efforts were more clearly defined and integrated. Papers reported in this session are: (1) regulatory implementation concepts and program overview; (2) licensing issue resolution; (3) status of NEPA activities in the NNWSI Program; (4) status of NEPA activities in the ONWI Program; (5) NWTS approach to site characterization reporting; and (6) quality assurance perspectives relative to licensing needs

Animal Health Ireland: providing national leadership and coordination of non-regulatory animal health issues in Ireland.

Science.gov (United States)

More, S J; Doherty, M L; Downey, L; McKenzie, K; Devitt, C; O'Flaherty, J

2011-12-01

Livestock production plays an important role in the Irish economy. Regulatory animal health issues are the responsibility of government, but until recently there has been no national coordination of non-regulatory animal health issues. This gap has recently been filled with the establishment of Animal Health Ireland (AHI), a not-for-profit, partnership-based organisation providing national leadership and coordination of non-regulatory animal health issues in Ireland. Animal Health Ireland provides benefits to livestock producers and processors by providing the knowledge, education and coordination required to establish effective control strategies, both on-farm and nationally. This paper presents a brief overview of the context for AHI, and of its establishment and initial activities. Non-regulatory animal health issues have been prioritised. A series of work programmes (each focusing on a high-priority issue) have been established. Partnership is critical to success, both for AHI as an organisation and for effective farm-level transfer of knowledge. This model for national leadership and coordination of non-regulatory animal health issues may be of relevance elsewhere.

Organizational performance and regulatory compliance as measured by clinical pertinence indicators before and after implementation of Anesthesia Information Management System (AIMS).

Science.gov (United States)

Choi, Clark K; Saberito, Darlene; Tyagaraj, Changa; Tyagaraj, Kalpana

2014-01-01

Previous studies have suggested that electronic medical records (EMR) can lead to a greater reduction of medical errors and better adherence to regulatory compliance than paper medical records (PMR). In order to assess the organizational performance and regulatory compliance, we tracked different clinical pertinence indicators (CPI) in our anesthesia information management system (AIMS) for 5 years. These indicators comprised of the protocols from the Surgical Care Improvement Project (SCIP), elements of performance (EP) from The Joint Commission (TJC), and guidelines from the Centers for Medicare and Medicaid Services (CMS). A comprehensive AIMS was initiated and the CPI were collected from October 5, 2009 to December 31, 2010 (EMR period) and from January 1, 2006 to October 4, 2009 (PMR period). Fourteen CPI were found to be common between the EMR and PMR periods. Based on the statistical analysis of the 14 common CPI, there was a significant increase (p < 0.001) in overall compliance after the introduction of EMR compared to the PMR period. The increase in overall compliance was significantly progressive (p = 0.013) from year to year over 2006 and 2010. Of the 14 CPI, Documentation of a) medication doses, and b) monitoring of postoperative physiological status, mental status, and pain scores showed significant improvement (p < 0.001) during the EMR period compared to the PMR period.

Telemental Health for Children and Adolescents: An Overview of Legal, Regulatory, and Risk Management Issues.

Science.gov (United States)

Kramer, Gregory M; Luxton, David D

2016-04-01

The use of technology to provide telemental healthcare continues to increase; however, little has been written about the legal and regulatory issues involved in providing this form of care to children and adolescents. This article reviews existing laws and regulations to summarize the risk management issues relevant to providing telemental healthcare to children and adolescents. There are several legal and regulatory areas in which telemental health clinicians need to have awareness. These areas include: 1) Licensure, 2) malpractice liability, 3) credentialing and privileging, 4) informed consent, 5) security and privacy, and 6) emergency management. Although legal and regulatory challenges remain in providing telemental healthcare to children and adolescents, it is possible to overcome these challenges with knowledge of the issues and appropriate risk management strategies. We provide general knowledge of these key legal and regulatory issues, along with some risk management recommendations.

Regulatory issues with multiplicity in drug approval: Principles and controversies in a changing landscape.

Science.gov (United States)

Benda, Norbert; Brandt, Andreas

2018-01-01

Recently, new draft guidelines on multiplicity issues in clinical trials have been issued by European Medicine Agency (EMA) and Food and Drug Administration (FDA), respectively. Multiplicity is an issue in clinical trials, if the probability of a false-positive decision is increased by insufficiently accounting for testing multiple hypotheses. We outline the regulatory principles related to multiplicity issues in confirmatory clinical trials intended to support a marketing authorization application in the EU, describe the reasons for an increasing complexity regarding multiple hypotheses testing and discuss the specific multiplicity issues emerging within the regulatory context and being relevant for drug approval.

Predicting Regulatory Compliance in Beer Advertising on Facebook.

Science.gov (United States)

Noel, Jonathan K; Babor, Thomas F

2017-11-01

The prevalence of alcohol advertising has been growing on social media platforms. The purpose of this study was to evaluate alcohol advertising on Facebook for regulatory compliance and thematic content. A total of 50 Budweiser and Bud Light ads posted on Facebook within 1 month of the 2015 NFL Super Bowl were evaluated for compliance with a self-regulated alcohol advertising code and for thematic content. An exploratory sensitivity/specificity analysis was conducted to determine if thematic content could predict code violations. The code violation rate was 82%, with violations prevalent in guidelines prohibiting the association of alcohol with success (Guideline 5) and health benefits (Guideline 3). Overall, 21 thematic content areas were identified. Displaying the product (62%) and adventure/sensation seeking (52%) were the most prevalent. There was perfect specificity (100%) for 10 content areas for detecting any code violation (animals, negative emotions, positive emotions, games/contests/promotions, female characters, minorities, party, sexuality, night-time, sunrise) and high specificity (>80%) for 10 content areas for detecting violations of guidelines intended to protect minors (animals, negative emotions, famous people, friendship, games/contests/promotions, minorities, responsibility messages, sexuality, sunrise, video games). The high prevalence of code violations indicates a failure of self-regulation to prevent potentially harmful content from appearing in alcohol advertising, including explicit code violations (e.g. sexuality). Routine violations indicate an unwillingness to restrict advertising content for public health purposes, and statutory restrictions may be necessary to sufficiently deter alcohol producers from repeatedly violating marketing codes. Violations of a self-regulated alcohol advertising code are prevalent in a sample of beer ads published on Facebook near the US National Football League's Super Bowl. Overall, 16 thematic content

Regulatory issues and assumptions associated with barriers in the vadose zone surrounding buried waste

International Nuclear Information System (INIS)

Siskind, B.; Heiser, J.

1993-02-01

One of the options for control of contaminant migration from buried waste sites is the construction of a subsurface barrier that consists of a wall of low permeability material. The barrier material should be compatible with soil and waste conditions specific to the site and have as low an effective diffusivity as is reasonably achievable to minimize or inhibit transport of moisture and contaminants. This report addresses the regulatory issues associated with the use of non-traditional organic polymer barriers as well as the use of soil-bentonite or cement-bentonite mixtures for such barriers, considering barriers constructed from these latter materials to be a regulatory baseline. The regulatory issues fall into two categories. The first category consists of issues associated with the acceptability of such barriers to the EPA as a method for achieving site or performanceimprovement. The second category encompasses those regulatory issues concerning health, safety and the environment which must be addressed regarding barrier installation and performance, especially if non-traditional materials are to be used

U.S. nuclear fuel cycle regulatory issues on exclusion, exemption, and clearance

International Nuclear Information System (INIS)

Meck, R.A.

1997-01-01

The U.S. Nuclear Regulatory Commission is considering the use of exclusion and clearance in connection with the nuclear fuel cycle regulations. Clearance of licensed lands, buildings, structures, materials, and equipment could expose members of the public to radiation in addition to background. Establishing and implementing dose criteria for allowed concentrations of radioactivity in the various media raise challenging issues for the regulator. Clearance also raises significant regulatory issues, and these issues reflect trade-offs between concerns for protecting public health and safety, as well as other socioeconomic values and concerns. At the heart of the issues are the adequacy of risk analyses, acceptability of risks, underlying rationales, feasibility and cost of implementation, and exposures of the public to man-made radiation in relation to natural sources of radiation. (author)

Major nuclear safety and regulatory issues in Korea

International Nuclear Information System (INIS)

Chang, Soon Heung

2004-01-01

Recently the value of nuclear energy is being re-considered due to the increase of oil price, the lack of energy supply, and the competition with renewable energy source. In Unites States, Europe, and East Asia, the prospects for continuous nuclear energy development or the policy for retaining nuclear energy have been announced. According to the nuclear energy promotion plan in Korea, there are 19 operating nuclear plants currently and more 7 plants will be constructed in the future. Until now, qualitative as well as quantitative growth is remarkable. Korean nuclear power plants achieved world-best level of capacity factor. However, because of the various nuclear industrial activities, we have a lot of regulatory issues for operating plants, building new plants, and other nuclear related facilities such as research reactors or radioactive waste storage facility. In this article, important regulatory issues which are emerging in Korea will be reviewed and the approaches to solve the issues including public acceptance will be presented. Especially, I will go into detail of two special case studies: The one is the thermal sleeve separation incident in Younggwang nuclear units 5 and 6 whose outage lasts about 80 days and 90 days respectively, which is not common in worldwide nuclear history. The other is about consensus meeting of Korea nuclear energy policy which was managed by a non-governmental organization. (author)

Compliance with NRC subsystem requirements in the repository licensing process

International Nuclear Information System (INIS)

Minwalla, H.

1994-01-01

Section 121 of the Nuclear Waste Policy Act of 1982 requires the Nuclear Regulatory Commission (Commission) to issue technical requirements and criteria, for the use of a system of multiple barriers in the design of the repository, that are not inconsistent with any comparable standard promulgated by the Environmental Protection Agency (EPA). The Administrator of the EPA is required to promulgate generally applicable standards for protection of the general environment from offsite releases from radioactive material in repositories. The Commission's regulations pertaining to geologic repositories are provided in 10 CFR part 60. The Commission has provided in 10 CFR 60.112 the overall post-closure system performance objective which is used to demonstrate compliance with the EPA high-level waste (HLW) disposal standard. In addition, the Commission has provided, in 10 CFR 60.113, subsystem performance requirements for substantially complete containment, fractional release rate, and groundwater travel time; however, none of these subsystem performance requirements have a causal technical nexus with the EPA HLW disposal standard. This paper examines the issue of compliance with the conflicting dual regulatory role of subsystem performance requirements in the repository licensing process and recommends several approaches that would appropriately define the role of subsystem performance requirements in the repository licensing process

Watershed monitoring and modelling and USA regulatory compliance.

Science.gov (United States)

Turner, B G; Boner, M C

2004-01-01

The aim of the Columbus program was to implement a comprehensive watershed monitoring-network including water chemistry, aquatic biology and alternative sensors to establish water environment health and methods for determining future restoration progress and early warning for protection of drinking water supplies. The program was implemented to comply with USA regulatory requirements including Total Maximum Daily Load (TMDL) rules of the Clean Water Act (CWA) and Source Water Assessment and Protection (SWAP) rules under the Safe Drinking Water Act (SDWA). The USEPA Office of Research and Development and the Water Environment Research Foundation provided quality assurance oversight. The results obtained demonstrated that significant wet weather data is necessary to establish relationships between land use, water chemistry, aquatic biology and sensor data. These measurements and relationships formed the basis for calibrating the US EPA BASINS Model, prioritizing watershed health and determination of compliance with water quality standards. Conclusions specify priorities of cost-effective drainage system controls that attenuate stormwater flows and capture flushed pollutants. A network of permanent long-term real-time monitoring using combination of continuous sensor measurements, water column sampling and aquatic biology surveys and a regional organization is prescribed to protect drinking water supplies and measure progress towards water quality targets.

Legal and Regulatory Frameworks for Decommissioning and Waste Management

International Nuclear Information System (INIS)

Leech, Jonathan

2016-01-01

Safe and efficient decommissioning and waste management requires clear structures for allocating responsibility and funding. Organisation of decommissioning and waste management activities and the regulatory environment within which those activities are undertaken should also allow the supply chain to prosper and, wherever possible, reduce barriers to international availability of resources and waste facilities. Radioactive waste treatment and disposal in particular raises both legal and political challenges to effective international co-operation, yet options for decommissioning and waste management are maximised where international barriers can be minimised. Added to this, international nuclear liabilities issues must be managed so as to avoid unnecessary deterrents to international mobility of capability within the decommissioning market. Contractual terms and insurance arrangements for international shipments of nuclear waste and materials will also need to take into account imminent changes to liabilities conventions, ensuring compliance and management of compliance costs (of both insurance and management time). This paper explores legal and commercial structures intended to support effective decommissioning and waste management and examines regulatory and commercial factors affecting the ability of facility operators to utilise internationally available capability. It focusses on: - strategic approaches developed in the UK to address decommissioning and waste management liabilities associated with the UK's first and second generation civil nuclear sites and comparison of those approaches with other jurisdictions with significant decommissioning liabilities; - liability and compliance risks associated with navigating international nuclear liabilities regimes in context of both mobility of decommissioning capability and international waste shipment; and - regulatory issues affecting international availability of waste treatment facilities, including

Developing regulatory approaches

International Nuclear Information System (INIS)

Axelsson, Lars

2012-01-01

Lars Axelsson presented SSM progress on oversight of LMfS/SC since the Chester 1 Workshop in 2007. Current SSM approaches for safety culture oversight include targeted safety management and safety culture inspections, compliance inspections which cover aspects of safety management/safety culture and multi-disciplinary team inspections. Examples of themes for targeted inspections include management of ambiguous operational situations or other weak signals, understanding of and attitudes to Human Performance tools, the Safety Department's role and authority and Leadership for safety. All regulatory activities provide inputs for the SSM yearly safety evaluation of each licensee. A form has been developed to capture safety culture observations from inspections and other interactions with licensees. Analysis will be performed to identify patterns and provide information to support planning of specific Safety Culture activities. Training has been developed for regulatory staff to enhance the quality of regulatory interventions on safety culture. This includes a half-day seminar to provide an overview of safety culture, and a workshop which provides more in-depth discussion on cultural issues and how to capture those during regulatory activities. Future plans include guidance for inspectors, and informal seminars on safety culture with licensees

OAI-PMH repositories : quality issues regarding metadata and protocol compliance, tutorial 1

CERN Multimedia

CERN. Geneva; Cole, Tim

2005-01-01

This tutorial will provide an overview of emerging guidelines and best practices for OAI data providers and how they relate to expectations and needs of service providers. The audience should already be familiar with OAI protocol basics and have at least some experience with either data provider or service provider implementations. The speakers will present both protocol compliance best practices and general recommendations for creating and disseminating high-quality "shareable metadata". Protocol best practices discussion will include coverage of OAI identifiers, date-stamps, deleted records, sets, resumption tokens, about containers, branding, errors conditions, HTTP server issues, and repository lifecycle issues. Discussion of what makes for good, shareable metadata will cover topics including character encoding, namespace and XML schema issues, metadata crosswalk issues, support of multiple metadata formats, general metadata authoring recommendations, specific recommendations for use of Dublin Core elemen...

Regulatory issues in the maintenance of Argentine nuclear power plants

International Nuclear Information System (INIS)

Castro, E.; Caruso, G.

1997-01-01

The influence of maintenance activities upon nuclear safety and their relevance as means to detect and prevent aging make them play an outstanding role among the fields of interest of the Argentine nuclear regulatory body (ENREN). Such interest is reinforced by the fact that the data obtained during maintenance are used - among other - as inputs in the Probabilistic Safety Analyses required for those nuclear power plants. This paper provides a brief description of the original requirements by the regulatory body concerning maintenance, of the factors that led to review the criteria involved in such requirements and of the key items identified during the reviewing process. The latter shall be taken into account in the maintenance regulatory policy, for the consequent issue of new requirements from the utilities and for the eventual publication of a specific regulatory standard. (author)

Outsourcing your medical practice call center: how to choose a vendor to ensure regulatory compliance.

Science.gov (United States)

Johnson, Bill

2014-01-01

Medical practices receive hundreds if not thousands of calls every week from patients, payers, pharmacies, and others. Outsourcing call centers can be a smart move to improve efficiency, lower costs, improve customer care, ensure proper payer management, and ensure regulatory compliance. This article discusses how to know when it's time to move to an outsourced call center, the benefits of making the move, how to choose the right call center, and how to make the transition. It also provides tips on how to manage the call center to ensure the objectives are being met.

Emergency Telemedicine: Achieving and Maintaining Compliance with the Emergency Medical Treatment and Labor Act.

Science.gov (United States)

Rockwell, Kimberly Lovett; Gilroy, Alexis

2018-03-12

Telemedicine is a growing and important platform for medical delivery in the emergency department. Emergency telemedicine outlays often confront and conflict with important federal healthcare regulations. Because of this, academic medical centers, critical access hospitals, and other providers interested in implementing emergency telemedicine have often delayed or forgone such services due to reasonable fears of falling out of compliance with regulatory restrictions imposed by the Emergency Medical Treatment and Labor Act ("EMTALA"). This article offers insights into methods for implementing emergency telemedicine services while maintaining EMTALA compliance. Critical analysis of EMTALA and its attendant regulations. The primary means of ensuring EMTALA compliance while implementing emergency telemedicine programs include incorporating critical clinical details into the services contracts and implementing robust written policies that anticipate division of labor issues, the need for backup coverage, triaging, patient transfer protocols, and credentialing issues. With adequate up-front due diligence and meaningful contracting, hospitals and telemedicine providers can avoid common EMTALA liability pitfalls.

Information management applications for the compliance function: a utility perspective

International Nuclear Information System (INIS)

Savoie, R.A.

1986-01-01

Today's complex and changing regulatory environment presents many challenges to those involved in the nuclear power industry. This is particularly true of technical personnel and managers involved in serving the compliance function for nuclear utilities. Adequately supporting the construction, startup, and operations of a nuclear power plant while simultaneously satisfying each regulatory requirement requires the meshing of thousands of individual regulatory tasks with each possible implementation option. The compliance function acts as a screen or filter between the regulatory bodies and the utility nuclear staff. Many varied approaches are taken by utilities in performing this compliance function, both from an organizational and information management perspective. The purpose of this paper is to describe the experiences of Louisiana Power and Light (LP and L) in developing its compliance function and to describe the innovative information management techniques LP and L has developed to serve this function

A study on the regulatory approach of major technical issues

Energy Technology Data Exchange (ETDEWEB)

Chang, Keun Sun; Choi, J. T.; Kim, I. J. [Sunmoon Univ., Asan (Korea, Republic of); Lee, S. H.; Baek, W. P.; Yang, S. H. [Korea Association for Nuclear Technology, Taejon (Korea, Republic of)

1998-06-15

This project is to provide the regulatory direction of 4 major technical issues for the Korean Next Generation Reactors, which are parts of major technical issues resulted from the safety regulation R and D on the KNGR. The outstanding results are as follows : reliability of risk significant SSCs established during design stage must be maintained through the operating life of the plant, currently used classification method of plant conditions and safety requirement were reviewed, and a quantitative classification method is needed to be developed further, the basic regulatory directions are proposed for multiple failures such as SBO, TLOFW, multiple SGTR and ATWS, safety requirements are proposed for survivability/availability of severe accident mitigation design features by 5 items if basic requirements, selection of initial event, identification of available equipment and instruments, identification of environmental conditions and verification methods.

Waste Isolation Pilot Plant Biennial Environmental Compliance Report

Energy Technology Data Exchange (ETDEWEB)

Westinghouse TRU Solutions

2000-12-01

This Biennial Environmental Compliance Report (BECR) documents environmental regulatory compliance at the Waste Isolation Pilot Plant (WIPP), a facility designed for the safe disposal of transuranic (TRU) radioactive waste, for the reporting period of April 1, 1998, to March 31, 2000. As required by the WIPP Land Withdrawal Act (LWA)(Public Law [Pub. L.] 102-579, and amended by Pub. L. 104-201), the BECR documents U.S. Department of Energy (DOE) Carlsbad Area Office's (hereinafter the ''CAO'') compliance with applicable environmental protection laws and regulations implemented by agencies of the federal government and the state of New Mexico. An issue was identified in the 1998 BECR relating to a potential cross-connection between the fire-water systems and the site domestic water system. While the CAO and its managing and operating contractor (hereinafter the ''MOC'') believe the site was always in compliance with cross-connection control requirements, hardware and procedural upgrades w ere implemented in March 1999 to strengthen its compliance posture. Further discussion of this issue is presented in section 30.2.2 herein. During this reporting period WIPP received two letters and a compliance order alleging violation of certain requirements outlined in section 9(a)(1) of the LWA. With the exception of one item, pending a final decision by the New Mexico Environment Department (NMED), all alleged violations have been resolved without the assessment of fines or penalties. Non-mixed TRU waste shipments began on March 26, 1999. Shipments continued through November 26, 1999, the effective date of the Waste Isolation Pilot Plant Hazardous Waste Facility Permit (NM4890139088-TSDF). No shipments regulated under the Hazardous Waste Facility Permit were received at WIPP during this BECR reporting period.

Waste Isolation Pilot Plant Biennial Environmental Compliance Report

International Nuclear Information System (INIS)

Westinghouse TRU Solutions

2000-01-01

This Biennial Environmental Compliance Report (BECR) documents environmental regulatory compliance at the Waste Isolation Pilot Plant (WIPP), a facility designed for the safe disposal of transuranic (TRU) radioactive waste, for the reporting period of April 1, 1998, to March 31, 2000. As required by the WIPP Land Withdrawal Act (LWA)(Public Law [Pub. L.] 102-579, and amended by Pub. L. 104-201), the BECR documents U.S. Department of Energy (DOE) Carlsbad Area Office's (hereinafter the ''CAO'') compliance with applicable environmental protection laws and regulations implemented by agencies of the federal government and the state of New Mexico. An issue was identified in the 1998 BECR relating to a potential cross-connection between the fire-water systems and the site domestic water system. While the CAO and its managing and operating contractor (hereinafter the ''MOC'') believe the site was always in compliance with cross-connection control requirements, hardware and procedural upgrades w ere implemented in March 1999 to strengthen its compliance posture. Further discussion of this issue is presented in section 30.2.2 herein. During this reporting period WIPP received two letters and a compliance order alleging violation of certain requirements outlined in section 9(a)(1) of the LWA. With the exception of one item, pending a final decision by the New Mexico Environment Department (NMED), all alleged violations have been resolved without the assessment of fines or penalties. Non-mixed TRU waste shipments began on March 26, 1999. Shipments continued through November 26, 1999, the effective date of the Waste Isolation Pilot Plant Hazardous Waste Facility Permit (NM4890139088-TSDF). No shipments regulated under the Hazardous Waste Facility Permit were received at WIPP during this BECR reporting period

Environmental Compliance Mechanisms

NARCIS (Netherlands)

Merkouris, Panagiotis; Fitzmaurice, Malgosia

2017-01-01

Compliance mechanisms can be found in treaties regulating such diverse issues as human rights, disarmament law, and environmental law. In this bibliography, the focus will be on compliance mechanisms of multilateral environmental agreements (MEAs). Compliance with norms of international

Regulatory issues of digital instrumentation and control system in Lungmen project

International Nuclear Information System (INIS)

Chuang, C.F.; Chou, H.P.

2004-01-01

The Lungmen Nuclear Power Station (LNPS) is currently under construction in Taiwan, which consists of 2 advanced boiling water reactor (ABWR) units. The instrumentation and control (IC) systems of the LNPS are based on the state-of-the-art modernized fully integrated digital design. These IC systems possess many advantages and distinguished features comparing to traditional analog IC systems, they enjoy set-point stability, self-diagnostic and automatic testing ability, fault tolerance and avoidance, low power requirements, data handling and storage capability, as well as enhanced human-machine interfaces. This paper presents regulatory overviews, regulatory requirements, current major regulatory issues, as well as the areas of regulatory concerns and the lessons learned on the digital IC systems in the Lungmen Project

Japan's regulatory and safety issues regarding nuclear materials transport

International Nuclear Information System (INIS)

Saito, T.; Yamanaka, T.

2004-01-01

This paper focuses on the regulatory and safety issues on nuclear materials transport which the Government of Japan (GOJ) faces and needs to well handle. Background information about the status of nuclear power plants (NPP) and nuclear fuel cycle (NFC) facilities in Japan will promote a better understanding of what this paper addresses

Directory of certificates of compliance for radioactive materials packages. Certificates of compliance

International Nuclear Information System (INIS)

1979-10-01

This volume contains all Certificates of Compliance for radioactive material packages effective September 14, 1979. Purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory

Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis

International Nuclear Information System (INIS)

MULKEY, C.H.

1999-01-01

This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through the DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues

An investment-production-regulatory model for firms in the offshore oil and gas industry

International Nuclear Information System (INIS)

Jin Di.

1991-01-01

This tripartite study examines the economic consequences of proposed environmental regulations on firms in the OCS oil and gas industry. The background part reviews the major issues associated with OCS oil and gas development and relevant environmental regulatory proposals. In the theoretical part, models are developed using optimal control theory and the theory of nonrenewable resources to analyze the impact of rising compliance cost on firm's behavior in terms of the investment and production rates over time. Finally, in the simulation part, an integrated investment-production-regulatory model is developed to simulate OCS development with and without the proposed environmental regulations. Effects of regulations are measured in terms of an increase in compliance costs and the associated reduction in net profits from oil and gas production. The theoretical results indicate that an increase in compliance costs will alter exploration, development and production rates. The total investments in exploration and development, and oil production will decrease as a result of rising compliance costs for exploration, development and production over the entire planning period

Environment, safety, and health regulatory implementation plan

International Nuclear Information System (INIS)

1993-01-01

To identify, document, and maintain the Uranium Mill Tailings Remedial Action (UMTRA) Project's environment, safety, and health (ES ampersand H) regulatory requirements, the US Department of Energy (DOE) UMTRA Project Office tasked the Technical Assistance Contractor (TAC) to develop a regulatory operating envelope for the UMTRA Project. The system selected for managing the UMTRA regulatory operating envelope data bass is based on the Integrated Project Control/Regulatory Compliance System (IPC/RCS) developed by WASTREN, Inc. (WASTREN, 1993). The IPC/RCS is a tool used for identifying regulatory and institutional requirements and indexing them to hardware, personnel, and program systems on a project. The IPC/RCS will be customized for the UMTRA Project surface remedial action and groundwater restoration programs. The purpose of this plan is to establish the process for implementing and maintaining the UMTRA Project's regulatory operating envelope, which involves identifying all applicable regulatory and institutional requirements and determining compliance status. The plan describes how the Project will identify ES ampersand H regulatory requirements, analyze applicability to the UMTRA Project, and evaluate UMTRA Project compliance status

Assessing the role of regulatory bodies in managing health professional issues and errors in Europe.

Science.gov (United States)

Risso-Gill, Isabelle; Legido-Quigley, H; Panteli, D; Mckee, M

2014-08-01

This paper explores how medical regulatory bodies in nine European countries manage professional issues involving quality and patient safety, to build on limited existing information on procedures for regulating medical professionals in Europe. Twelve vignettes describing scenarios of concerns about standards of physicians were developed, covering clinical, criminal and administrative matters. Medical regulatory bodies in nine European countries were asked what action they would normally take in each situation. Their responses were related to their regulatory mandate. Responses varied greatly across participating countries. Regulators are always involved where patients are at risk or where a criminal offence is committed within the clinical setting. Non-criminal medical issues were generally handled by the employer, if any, at their discretion. Countries varied in the use of punitive measures, the extent to which they took an interest in issues arising outside professional activities, and whether they dealt with issues themselves or referred cases to another regulatory authority or took no action at all. There is little consistency across Europe on the regulation of medical professionals. There is considerable diversity in the range of topics that regulatory bodies oversee, with almost all covering health care quality and safety and others encompassing issues related to reputation, respect and trust. These inconsistencies have significant implications for professional mobility, patient safety and quality of care. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Management initiatives to waste management decisions and environmental compliance in Oak Ridge, Tennessee

Energy Technology Data Exchange (ETDEWEB)

Jones, C.G.

1988-01-01

Martin Marietta Energy Systems, Inc. (MMES) has been the operating contractor for the nuclear production and research facilities at Oak Ridge, Tennessee and Paducah, Kentucky for about four and one-half years. Environmental compliance, regulatory interaction, and public confidence have been very significant issues during this time. This presentation will review the environmental situation in Oak Ridge in 1984 and will discuss management initiatives and experience in the development and implementation of effective environmental and waste management and health and safety programs committed to the protection of the environment, our workers and the public with an overall goal of full compliance with all current and anticipated regulations.

Management initiatives to waste management decisions and environmental compliance in Oak Ridge, Tennessee

International Nuclear Information System (INIS)

Jones, C.G.

1988-01-01

Martin Marietta Energy Systems, Inc. (MMES) has been the operating contractor for the nuclear production and research facilities at Oak Ridge, Tennessee and Paducah, Kentucky for about four and one-half years. Environmental compliance, regulatory interaction, and public confidence have been very significant issues during this time. This presentation will review the environmental situation in Oak Ridge in 1984 and will discuss management initiatives and experience in the development and implementation of effective environmental and waste management and health and safety programs committed to the protection of the environment, our workers and the public with an overall goal of full compliance with all current and anticipated regulations

Proactive Public Disclosure: A new regulatory strategy for creating tax compliance?

Directory of Open Access Journals (Sweden)

Boll Karen

2015-12-01

Full Text Available This article discusses proactive public disclosure of taxpayer information and how this may form a new strategy for securing tax compliance by tax administrators. It reports a case study from the Danish Customs and Tax Administration in which consumers of services-over a short period of time-were informed about businesses’ lack of value-added tax (VAT registration. Our approach to the case is twofold: First, the article lays out a legal analysis of the disclosure practice, and second, the article presents an organizational analysis of why the practice was initiated. The analyses show that using proactive public disclosure is compatible with the Duty of Confidentiality, but incompatible with Good Public Governance. Furthermore, the analyses show that there are a number of strong organizational rationales for using proactive public disclosure, despite its apparent incompatibility with Good Public Governance. The article is innovative in that it combines a legal and organizational approach to analyse a new regulatory strategy within tax administration.

Regulatory Oversight Program, July 1, 1993 - March 3, 1997. Volume 1

International Nuclear Information System (INIS)

1997-09-01

On July 1, 1993, a Regulatory Oversight (RO) organization was established within the United States Department of Energy (DOE), Oak Ridge Operations (ORO) to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the RO program was to ensure continued plant safety, safeguards and security while the Paducah and Portsmouth gaseous diffusion plants (GDPs) transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). These activities were performed under the authority of the lease agreement between DOE and USEC until NRC issued a Certificate of Compliance or approved a Compliance Plan pursuant to Section 1701 of the Atomic Energy Act of 1954, as amended, and assumed regulatory responsibility. This report chronicles the formal development, operation and key activities of the RO organization from its beginning in July 1993, until the turnover of the regulatory oversight responsibility to the NRC on March 3, 1997. Through its evolution to closure, the RO program was a formal, proceduralized effort designed to provide consistent regulation and to facilitate transition to NRC. The RO Program was also a first-of-a-kind program for DOE. The process, experience, and lessons learned summarized herein should be useful as a model for transition of other DOE facilities to privatization or external regulation

Regulatory Oversight Program, July 1, 1993--March 3, 1997. Volume 1

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-09-01

On July 1, 1993, a Regulatory Oversight (RO) organization was established within the United States Department of Energy (DOE), Oak Ridge Operations (ORO) to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the RO program was to ensure continued plant safety, safeguards and security while the Paducah and Portsmouth gaseous diffusion plants (GDPs) transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). These activities were performed under the authority of the lease agreement between DOE and USEC until NRC issued a Certificate of Compliance or approved a Compliance Plan pursuant to Section 1701 of the Atomic Energy Act of 1954, as amended, and assumed regulatory responsibility. This report chronicles the formal development, operation and key activities of the RO organization from its beginning in July 1993, until the turnover of the regulatory oversight responsibility to the NRC on March 3, 1997. Through its evolution to closure, the RO program was a formal, proceduralized effort designed to provide consistent regulation and to facilitate transition to NRC. The RO Program was also a first-of-a-kind program for DOE. The process, experience, and lessons learned summarized herein should be useful as a model for transition of other DOE facilities to privatization or external regulation.

77 FR 12089 - Proposed Generic Communication; Regulatory Issue Summary 2012-XX: Developing Inservice Testing...

Science.gov (United States)

2012-02-28

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0048] Proposed Generic Communication; Regulatory Issue... CFR) Part 52, ``Licenses, Certifications, and Approvals for Nuclear Power Plants,'' to satisfy the... inservice testing programs during the initial 120-month program interval following nuclear power plant...

Waste Isolation Pilot Plant Biennial Environmental Compliance Report

Energy Technology Data Exchange (ETDEWEB)

Washinton TRU Solutions LLC

2002-09-30

This Biennial Environmental Compliance Report (BECR) documents environmental regulatory compliance at the Waste Isolation Pilot Plant (WIPP), a facility designed for the safe disposal of transuranic (TRU) radioactive waste, for the reporting period of April 1, 2000, to March 31, 2002. As required by the WIPP Land Withdrawal Act (LWA)(Public Law [Pub. L.] 102-579, as amended by Pub. L. 104-201), the BECR documents U.S. Department of Energy (DOE) Carlsbad Field Office's (CBFO) compliance with applicable environmental protection laws and regulations implemented by agencies of the federal government and the state of New Mexico. In the prior BECR, the CBFO and the management and operating contractor (MOC)committed to discuss resolution of a Letter of Violation that had been issued by the New Mexico Environment Department (NMED) in August 1999, which was during the previous BECR reporting period. This Letter of Violation alleged noncompliance with hazardous waste aisle spacing, labeling, a nd tank requirements. At the time of publication of the prior BECR, resolution of the Letter of Violation was pending. On July 7, 2000, the NMED issued a letter noting that the aisle spacing and labeling concerns had been adequately addressed and that they were rescinding the violation alleging that the Exhaust Shaft Catch Basin failed to comply with the requirements for a hazardous waste tank. During the current reporting period, WIPP received a Notice of Violation and a compliance order alleging the violation of the New Mexico Hazardous Waste Regulations and the WIPP Hazardous Waste Facility Permit (HWFP).

Waste Isolation Pilot Plant Biennial Environmental Compliance Report

International Nuclear Information System (INIS)

Washinton TRU Solutions LLC

2002-01-01

This Biennial Environmental Compliance Report (BECR) documents environmental regulatory compliance at the Waste Isolation Pilot Plant (WIPP), a facility designed for the safe disposal of transuranic (TRU) radioactive waste, for the reporting period of April 1, 2000, to March 31, 2002. As required by the WIPP Land Withdrawal Act (LWA)(Public Law [Pub. L.] 102-579, as amended by Pub. L. 104-201), the BECR documents U.S. Department of Energy (DOE) Carlsbad Field Office's (CBFO) compliance with applicable environmental protection laws and regulations implemented by agencies of the federal government and the state of New Mexico. In the prior BECR, the CBFO and the management and operating contractor (MOC)committed to discuss resolution of a Letter of Violation that had been issued by the New Mexico Environment Department (NMED) in August 1999, which was during the previous BECR reporting period. This Letter of Violation alleged noncompliance with hazardous waste aisle spacing, labeling, a nd tank requirements. At the time of publication of the prior BECR, resolution of the Letter of Violation was pending. On July 7, 2000, the NMED issued a letter noting that the aisle spacing and labeling concerns had been adequately addressed and that they were rescinding the violation alleging that the Exhaust Shaft Catch Basin failed to comply with the requirements for a hazardous waste tank. During the current reporting period, WIPP received a Notice of Violation and a compliance order alleging the violation of the New Mexico Hazardous Waste Regulations and the WIPP Hazardous Waste Facility Permit (HWFP)

The Canadian Nuclear Safety Commission Compliance Program for Uranium Mines and Mills

Energy Technology Data Exchange (ETDEWEB)

Schryer, D., E-mail: denis.schryer@cnsc-ccsn.gc.ca [Canadian Nuclear Safety Commission, Saskatoon, Saskatchewan (Canada)

2014-05-15

The Canadian Nuclear Safety Commission (CNSC) is the principal nuclear regulator in Canada. The CNSC is empowered through the Nuclear Safety and Control Act (NSCA) and its associated regulations, to regulate the entire nuclear cycle which includes: uranium mining and milling, uranium refining and processing, fuel fabrication, power generation and nuclear waste management. A CNSC uranium mine licence is required by a proponent to site, prepare, construct, operate, decommission and abandon this nuclear facility. The CNSC licence is the legal instrument that authorizes the regulated activities and incorporates conditions and regulatory controls. Following a favourable Commission Tribunal decision to issue a licence to authorize the licensed activities, CNSC develops and executes a compliance plan of the licensee’s programs and procedures. The CNSC compliance plan is risk-informed and applies its resources to the identified higher risk areas. The compliance program is designed to encourage compliance by integrating three components: promotion, verification and enforcement and articulates the CNSC expectations to attain and maintain compliance with its regulatory requirements. The licensee performance is assessed through compliance activities and reported to the Commission to inform the licensing process during licence renewal. The application of the ongoing compliance assessment and risk management model ensures that deviations from impact predictions are addressed in a timely manner. The Uranium Mines and Mills Division of the CNSC are preparing to meet the challenges of the planned expansion of their Canadian uranium mining industry. The presentation will discuss these challenges and the measures required to address them. The Uranium Mines and Mills Division (UMMD) have adopted a structured compliance framework which includes formal procedures to conduct site inspections. New UMMD staff are trained to apply the regulations to licensed sites and to manage non-compliance

Managing quality and compliance.

Science.gov (United States)

McNeil, Alice; Koppel, Carl

2015-01-01

Critical care nurses assume vital roles in maintaining patient care quality. There are distinct facets to the process including standard setting, regulatory compliance, and completion of reports associated with these endeavors. Typically, multiple niche software applications are required and user interfaces are varied and complex. Although there are distinct quality indicators that must be tracked as well as a list of serious or sentinel events that must be documented and reported, nurses may not know the precise steps to ensure that information is properly documented and actually reaches the proper authorities for further investigation and follow-up actions. Technology advances have permitted the evolution of a singular software platform, capable of monitoring quality indicators and managing all facets of reporting associated with regulatory compliance.

Reactivation of nuclear power plant construction projects. Plant status, policy issues and regulatory options

International Nuclear Information System (INIS)

Spangler, M.B.

1986-07-01

Prior to the TMI-2 accident on March 28, 1979, four nuclear power plant units that had previously been issued a construction permit were cancelled, principally because of reduced projections of regional power demand. Since that time, an additional 31 units with CPs have been cancelled and eight units deferred. On December 23, 1985 one of the deferred units (Limerick-2) was reactivated and construction resumed. The primary objective of this policy study is to identify the principal issues requiring office-level consideration in the event of reactivation of the construction of one or more of the nuclear power plants falling into two categories: (1) LWR units issued a construction permit whose construction has been cancelled, and (2) LWR units whose construction has been deferred. The study scope is limited to identifying regulatory issues or questions deserving analysis rather than providing, at this time, answers or recommended actions. Five tasks are addressed: a tabulation and discussion of the status of all cancelled and deferred LWR units; and identification of potential safety and environmental issues; an identification of regulatory or policy issues and needed information to determine the desirability of revising certain rules and policies; and identification of regulatory options and decision criteria; and an identification of decision considerations in determining staff requirements and organizational coordination of LWR reactivation policy and implementation efforts. 41 refs

Regulatory Compliance to Assure the Safety of the Operation of a Medical Cyclotron

International Nuclear Information System (INIS)

Dela Cruz, Joselito

2015-01-01

Khealth Corporation, in Partnership with the National Kidney and Transplant Institute, has established a medical cyclotron facility to accommodate the up-and-coming needs of tracers for PET/CT in different centers and hospitals all over the country. This facility houses a 16.5 MeV GE PET trace 880 particle accelerator that can produce 14 Ci (518 GBq) of Fluorine-18. Its structure has adopted global standard designs in meeting the safety during its use, radiopharmaceutical production and distribution. Compliances were remarkably fulfilled from the building construction, machine acquisition, commissioning, operations up to the quality control and assurance. Furthermore, various regulatory challenges during the current standardization of radiopharmaceutical utilization were encountered however time dedication and efforts were wielded until all have been successfully justified and acquired. (author)

SU-F-P-10: A Web-Based Radiation Safety Relational Database Module for Regulatory Compliance

Energy Technology Data Exchange (ETDEWEB)

Rosen, C; Ramsay, B; Konerth, S; Roller, D; Ramsay, A [Dade Moeller Health Group, Kalamazoo, MI (United States)

2016-06-15

Purpose: Maintaining compliance with Radioactive Materials Licenses is inherently a time-consuming task requiring focus and attention to detail. Staff tasked with these responsibilities, such as the Radiation Safety Officer and associated personnel must retain disparate records for eventual placement into one or more annual reports. Entering results and records in a relational database using a web browser as the interface, and storing that data in a cloud-based storage site, removes procedural barriers. The data becomes more adaptable for mining and sharing. Methods: Web-based code was written utilizing the web framework Django, written in Python. Additionally, the application utilizes JavaScript for front-end interaction, SQL, HTML and CSS. Quality assurance code testing is performed in a sequential style, and new code is only added after the successful testing of the previous goals. Separate sections of the module include data entry and analysis for audits, surveys, quality management, and continuous quality improvement. Data elements can be adapted for quarterly and annual reporting, and for immediate notification of user determined alarm settings. Results: Current advances are focusing on user interface issues, and determining the simplest manner by which to teach the user to build query forms. One solution has been to prepare library documents that a user can select or edit in place of creation a new document. Forms are being developed based upon Nuclear Regulatory Commission federal code, and will be expanded to include State Regulations. Conclusion: Establishing a secure website to act as the portal for data entry, storage and manipulation can lead to added efficiencies for a Radiation Safety Program. Access to multiple databases can lead to mining for big data programs, and for determining safety issues before they occur. Overcoming web programming challenges, a category that includes mathematical handling, is providing challenges that are being overcome.

SU-F-P-10: A Web-Based Radiation Safety Relational Database Module for Regulatory Compliance

International Nuclear Information System (INIS)

Rosen, C; Ramsay, B; Konerth, S; Roller, D; Ramsay, A

2016-01-01

Purpose: Maintaining compliance with Radioactive Materials Licenses is inherently a time-consuming task requiring focus and attention to detail. Staff tasked with these responsibilities, such as the Radiation Safety Officer and associated personnel must retain disparate records for eventual placement into one or more annual reports. Entering results and records in a relational database using a web browser as the interface, and storing that data in a cloud-based storage site, removes procedural barriers. The data becomes more adaptable for mining and sharing. Methods: Web-based code was written utilizing the web framework Django, written in Python. Additionally, the application utilizes JavaScript for front-end interaction, SQL, HTML and CSS. Quality assurance code testing is performed in a sequential style, and new code is only added after the successful testing of the previous goals. Separate sections of the module include data entry and analysis for audits, surveys, quality management, and continuous quality improvement. Data elements can be adapted for quarterly and annual reporting, and for immediate notification of user determined alarm settings. Results: Current advances are focusing on user interface issues, and determining the simplest manner by which to teach the user to build query forms. One solution has been to prepare library documents that a user can select or edit in place of creation a new document. Forms are being developed based upon Nuclear Regulatory Commission federal code, and will be expanded to include State Regulations. Conclusion: Establishing a secure website to act as the portal for data entry, storage and manipulation can lead to added efficiencies for a Radiation Safety Program. Access to multiple databases can lead to mining for big data programs, and for determining safety issues before they occur. Overcoming web programming challenges, a category that includes mathematical handling, is providing challenges that are being overcome.

Brand names of Portuguese medication: understanding the importance of their linguistic structure and regulatory issues.

Science.gov (United States)

Pires, Carla; Vigário, Marina; Cavaco, Afonso

2015-08-01

Among other regulatory requirements, medicine brands should be composed of single names without abbreviations to prevent errors in prescription of medication. The purposes of the study were to investigate the compliance of a sam ple of Portuguese medicine brand names with Portuguese pharmaceutical regulations. This includes identifying their basic linguistic characteristics and comparing these features and their frequency of occurrence with benchmark values of the colloquial or informal language. A sample of 474 brand names was selected. Names were analyzed using manual (visual analyses) and computer methods (FreP - Frequency Patterns of Phonological Objects in Portuguese and MS word). A significant number of names (61.3%) failed to comply with the Portuguese phonologic system (related to the sound of words) and/or the spelling system (related to the written form of words) contained more than one word, comprised a high proportion of infrequent syllable types or stress patterns and included abbreviations. The results suggest that some of the brand names of Portuguese medication should be reevaluated, and that regulation on this issue should be enforced and updated, taking into consideration specific linguistic and spelling codes.

Resolving the problem of compliance with the ever increasing and changing regulations

International Nuclear Information System (INIS)

Leigh, H.

1991-09-01

The most common problem identified at several US Department of Energy (DOE) sites is regulatory compliance. Simply, the project viability depends on identifying regulatory requirements at the beginning of a specific project to avoid possible delays and cost overruns. The Radioisotope Power Systems Facility (RPSF) is using the Regulatory Compliance System (RCS) to deal with the problem that well over 1000 regulatory documents had to reviewed for possible compliance requirements applicable to the facility. This overwhelming number of possible documents is not atypical of all DOE facilities thus far reviewed using the RCS system. The RCS was developed to provide control and tracking of all the regulatory and institutional requirements on a given project. WASTREN, Inc., developed the RCS through various DOE contracts and continues to enhance and update the system for existing and new contracts. The RCS provides the information to allow the technical expert to assimilate and manage accurate resource information, compile the necessary checklists, and document that the project or facility fulfills all of the appropriate regulatory requirements. The RCS provides on-line information, including status throughout the project life, thereby allowing more intelligent and proactive decision making. Also, consistency and traceability are provided for regulatory compliance documentation. 1 ref., 1 fig

Implementation of Good Laboratory Practices (GLP) in basic scientific research: Translating the concept beyond regulatory compliance.

Science.gov (United States)

Jena, G B; Chavan, Sapana

2017-10-01

The principles of Good Laboratory Practices (GLPs) are mainly intended for the laboratories performing studies for regulatory compliances. However, today GLP can be applied to broad disciplines of science to cater to the needs of the experimental objectives, generation of quality data and assay reproducibility. Considering its significance, it can now be applied in academics; industries as well as government set ups throughout the world. GLP is the best way to promote the reliability, reproducibility of the test data and hence facilitates the international acceptability. Now it is high time to translate and implement the concept of GLP beyond regulatory studies. Thus, it can pave the way for better understanding of scientific problems and help to maintain a good human and environmental health. Through this review, we have made an attempt to explore the uses of GLP principles in different fields of science and its acceptability as well as looking for its future perspectives. Copyright © 2017 Elsevier Inc. All rights reserved.

Selected review of regulatory standards and licensing issues for nuclear power plants

International Nuclear Information System (INIS)

Stevenson, J.D.; Thomas, F.A.

1982-11-01

This report presents a compilation and description of current foreign regulatory standards and licensing issues in the areas of interest associated with Siting, Structural Engineering, Metallurgy and Materials, and Mechanical Engineering. In addition, summary comparisons of the requirements of both the US and foreign nuclear power plant regulatory standards are provided. The selected foreign countries surveyed include Canada, France, Japan, Sweden, United Kingdom of Great Britain and Northern Ireland, and the Federal Republic of Germany

Straight chiropractic philosophy as a barrier to Medicare compliance: a discussion of 5 incongruent issues.

Science.gov (United States)

Seaman, David R; Soltys, Jonathan R

2013-12-01

The purpose of this commentary is to discuss potential 5 factors within straight chiropractic philosophy and practice that may prevent Medicare compliance. The national Medicare Benefit Policy Manual and the Florida Local Coverage Determination were reviewed to identify documentation and conceptual issues regarding chiropractic practice. Five Medicare positions were contrasted with tenets of straight chiropractic philosophy. Based on Medicare's documentation requirements, Medicare defines subluxation and chiropractic practice from the perspective of treating spinal pain and related functional disability. In contrast, traditional straight chiropractic philosophy is not based on the treatment of spinal pain and disability or other symptomatic presentations. In this context, 5 potential areas of conflict are discussed. The Medicare version of chiropractic practice is not consistent with traditional straight chiropractic philosophy, which may play a role in preventing Medicare compliance. The chiropractic profession may need to consider the fashion in which "philosophy" as it relates to technique and practice is presented to students and doctors to facilitate compliance with the documentation requirements of Medicare.

Regulatory issues on using programmable logic device in nuclear power plants

International Nuclear Information System (INIS)

Park, G. Y.; Yu, Y. J.; Kim, H. T.; Kwon, Y. I.; Park, H. S.; Jeong, C. H.

2012-01-01

For replacing obsolete analog equipment in nuclear power plant, the Programmable Logic Devices (PLDs) using Hardware Description Language (HDL) have been widely adopted in digitalized Instrumentation and Control (I and C) systems because of its flexibility. For safety reviews on Nuclear Power Plants (NPPs,) qualifying digitalized safety I and C system using PLDs is an important issue. As an effort to provide regulatory position on using PLDs in safety I and C system, there is a research project to provide the regulatory positions against emerging issues involved with digitalisation of I and C system including using PLDs. Therefore, this paper addresses the important considerations for using PLDs in safety I and C systems such as diversity, independence and qualification, etc. In this point, this study focuses on technical reports for Field Programmable Gate Array (FPGA) from EPRI,. U.S. NRC, and relevant technical standards

Regulatory issues on using programmable logic device in nuclear power plants

Energy Technology Data Exchange (ETDEWEB)

Park, G. Y.; Yu, Y. J.; Kim, H. T.; Kwon, Y. I.; Park, H. S.; Jeong, C. H. [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2012-10-15

For replacing obsolete analog equipment in nuclear power plant, the Programmable Logic Devices (PLDs) using Hardware Description Language (HDL) have been widely adopted in digitalized Instrumentation and Control (I and C) systems because of its flexibility. For safety reviews on Nuclear Power Plants (NPPs,) qualifying digitalized safety I and C system using PLDs is an important issue. As an effort to provide regulatory position on using PLDs in safety I and C system, there is a research project to provide the regulatory positions against emerging issues involved with digitalisation of I and C system including using PLDs. Therefore, this paper addresses the important considerations for using PLDs in safety I and C systems such as diversity, independence and qualification, etc. In this point, this study focuses on technical reports for Field Programmable Gate Array (FPGA) from EPRI,. U.S. NRC, and relevant technical standards.

Regulation and perceived compliance: Nonpoint pollution reduction programs in four states

International Nuclear Information System (INIS)

Floyd, D.W.; MacLeod, M.A.

1993-01-01

Examining nonpoint-source water pollution programs in foresty is one way of looking at the complicated policy questions of striking a balance between voluntary and regulatory approaches to forest management on private lands. States have developed a variety of approaches in this area from completely voluntary to highly regulatory to archeive compliance. This article looks at several aspects: federal requirements, program types, predictive behavior theories, and specific state programs (Ohio, West Virginia, Maryland, Massachusetts). The study results indicate a significant difference in preceived compliance based on program type: as stringency increases, perceived compliance increases. The authors suggest that successful forestry nonpoint source water pollution reduction plans should combine regulatory and educational elements. 16 refs., 3 tabs

Workshop on Regulatory Review and Safety Assessment Issues in Repository Licensing

International Nuclear Information System (INIS)

Wilmot, Roger D.

2011-02-01

The workshop described here was organised to address more general issues regarding regulatory review of SKB's safety assessment and overall review strategy. The objectives of the workshop were: - to learn from other programmes' experiences on planning and review of a license application for a nuclear waste repository, - to offer newly employed SSM staff an opportunity to learn more about selected safety assessment issues, and - to identify and document recommendations and ideas for SSM's further planning of the licensing review

ICF's Plant Compliance Assessment System

International Nuclear Information System (INIS)

Baker, S.M.

1989-01-01

Government and private industrial facilities must manage wastes that are both radioactive and (chemically) hazardous. Until recently, these mixed wastes have been managed under rules established under the Atomic Energy Act (AEA) and the Low-Level Waste Policy At, and rules that derive from environmental legislation have not been applied. Both sets of rules now apply to mixed wastes, creating situations in which significant changes to waste steams must be made in order to bring them into compliance with environmental regulations. The first step in bringing waste streams into compliance is to determine their status with respect to the newly-applicable regulations. This process of compliance assessment is difficult because requirements to minimize human exposure to radiation can conflict with requirements of environmental regulations, many regulations are potentially applicable, the regulations are changing rapidly, and because waste streams designed to operate under AEA rules frequently cannot be easily modified to incorporate the additional regulations. Modern personal computer (PC) tools are being developed to help regulatory analysts manage the large amounts of information required to asses the compliance status of complex process plants. This paper presents the Plant Compliance Assessment System (PCAS), which performs this function by relating a database containing references to regulatory requirements to databases created to describe relevant aspects of the facility to be assessed

Transportation safety through regulatory compliance training is the key to success

International Nuclear Information System (INIS)

Carnes, N.; Stancell, D.; Willaford, D.; Blalock, L.

1989-01-01

The US Department of Energy (DOE) has a strong commitment to ensure the safe and efficient transportation of hazardous materials, and achieves this goal through compliance with the regulations. DOEs commitment to excellence in this area is reflected by the Transportation Management Divisions support of compliance training workshops for DOE/DOE contractor personnel. Training is the key to compliance. This paper will address the current compliance training program, and new initiatives by DOE

Regulatory facility guide for Ohio

Energy Technology Data Exchange (ETDEWEB)

Anderson, S.S.; Bock, R.E.; Francis, M.W.; Gove, R.M.; Johnson, P.E.; Kovac, F.M.; Mynatt, J.O. [Oak Ridge National Lab., TN (United States); Rymer, A.C. [Transportation Consulting Services, Knoxville, TN (United States)

1994-02-28

The Regulatory Facility Guide (RFG) has been developed for the DOE and contractor facilities located in the state of Ohio. It provides detailed compilations of international, federal, and state transportation-related regulations applicable to shipments originating at destined to Ohio facilities. This RFG was developed as an additional resource tool for use both by traffic managers who must ensure that transportation operations are in full compliance with all applicable regulatory requirements and by oversight personnel who must verify compliance activities.

Choices that increase compliance

International Nuclear Information System (INIS)

Edwards, P.R.

1991-01-01

A compliance model is developed and tested using a survey of corporate officials and the regulatory arena of equal employment opportunity. Findings support the economic model of compliance in its conclusion that probability of detection and probable level of sanctions influence compliance decisions. Results also indicate that adjustments to the model that account for bounded rationality are valid. The key outcome, however, is that although all types of investigations play some role in enhancing compliance, those that stress sanctions and thus severity rather than certainty of detection may have the greatest positive influence on compliance. Enforcement programs attempting to operate simply as investigators of small-scale complaints will have less success than those with different types of investigations or a balanced type of single investigation. The results also suggest a more complex cognitive process on the part of regulated individuals than initially theorized. 34 refs., 3 tabs

Regulatory and institutional issues impending cleanup at US Department of Energy sites: Perspectives gained from an office of environmental restoration workshop

Energy Technology Data Exchange (ETDEWEB)

Fallon, W E; Gephart, J M; Gephart, R E; Quinn, R D; Stevenson, L A

1991-05-01

The US Department of Energy's (DOE) nuclear weapons and energy operations are conducted across a nation-wide industrial complex engaged in a variety of manufacturing, processing, testing, and research and development activities. The overall mission of DOE Office of Environmental Restoration and Waste Management (EM) is to protect workers, the public, and the environment from waste materials generated by past, current, and future DOE activities and to bring the DOE complex into compliance with all applicable laws, regulations, and agreements related to health, safety, and the environment. EM addresses this broad mandate through related and interdependent programs that include corrective actions, waste operations, environmental restoration, and technology development. The EM Office of Environmental Restoration (EM-40) recognizes the importance of implementing a complex-wide process to identify and resolve those issues that may impede progress towards site cleanup. As a first step in this process, FM-40 sponsored an exercise to identify and characterize major regulatory and institutional issues and to formulate integrated action steps towards their resolution. This report is the first product of that exercise. It is intended that the exercise described here will mark the beginning of an ongoing process of issue identification, tracking, and resolution that will benefit cleanup activities across the DOE complex.

A workflow for SHPs regulatory compliance in the wholesale market metering system; Workflow para adequacao regulatoria da medicao de faturamento em PCHs

Energy Technology Data Exchange (ETDEWEB)

Barbosa, Danilo Ulisses Soares; Vidal, Fernando de Moura; Mariano, Alex [Way2 Servicos de Tecnologia S.A., Florianopolis, SC (Brazil)], E-mail: way2@way2.com.br

2011-07-15

CCEE regulatory compliance is a critical and necessary process to the beginning of the commercial operation of generation plants. Even when this stage is completed, the small-team nature of a PCH work crew, their rushed work pace and typical turnover on the matter of their role at the plant make difficult the task of monitoring the demands and processes, which increases the penalty risk. The current article analyses CCEE commercial procedures (PdCs) and ONS Network Procedures, emphasizing activities and workflow which are in compliancy to regulation. Primarily the asset registering process is described in details, from project elaboration and approval until CCEE final validation. After that, the article summarizes all criteria for penalties application regarding wholesale energy metering compliance, missing data and audit channel Unavailability. Besides that, there is a focus on a workflow definition in order to mitigate penalties risk. (author)

30 CFR 772.13 - Coal exploration compliance duties.

Science.gov (United States)

2010-07-01

... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Coal exploration compliance duties. 772.13... INTERIOR SURFACE COAL MINING AND RECLAMATION OPERATIONS PERMITS AND COAL EXPLORATION SYSTEMS UNDER REGULATORY PROGRAMS REQUIREMENTS FOR COAL EXPLORATION § 772.13 Coal exploration compliance duties. (a) All...

Directory of certificates of compliance for radioactive materials packages, Certificates of compliance

International Nuclear Information System (INIS)

1990-10-01

This directory contains a Report of the US Nuclear Regulatory Commissions's Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Materials Packages effective October 1, 1990. The purpose of this directory is to make available a convenient source of information on packaging which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of easy package design and approved QA programs prior to the publication date of the directory

Directory of Certificates of Compliance for Radioactive Materials Packages: Certificates of Compliance

International Nuclear Information System (INIS)

1988-12-01

This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), all Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective October 1, 1988. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

Compliance Groundwater Monitoring of Nonpoint Sources - Emerging Approaches

Science.gov (United States)

Harter, T.

2008-12-01

Groundwater monitoring networks are typically designed for regulatory compliance of discharges from industrial sites. There, the quality of first encountered (shallow-most) groundwater is of key importance. Network design criteria have been developed for purposes of determining whether an actual or potential, permitted or incidental waste discharge has had or will have a degrading effect on groundwater quality. The fundamental underlying paradigm is that such discharge (if it occurs) will form a distinct contamination plume. Networks that guide (post-contamination) mitigation efforts are designed to capture the shape and dynamics of existing, finite-scale plumes. In general, these networks extend over areas less than one to ten hectare. In recent years, regulatory programs such as the EU Nitrate Directive and the U.S. Clean Water Act have forced regulatory agencies to also control groundwater contamination from non-incidental, recharging, non-point sources, particularly agricultural sources (fertilizer, pesticides, animal waste application, biosolids application). Sources and contamination from these sources can stretch over several tens, hundreds, or even thousands of square kilometers with no distinct plumes. A key question in implementing monitoring programs at the local, regional, and national level is, whether groundwater monitoring can be effectively used as a landowner compliance tool, as is currently done at point-source sites. We compare the efficiency of such traditional site-specific compliance networks in nonpoint source regulation with various designs of regional nonpoint source monitoring networks that could be used for compliance monitoring. We discuss advantages and disadvantages of the site vs. regional monitoring approaches with respect to effectively protecting groundwater resources impacted by nonpoint sources: Site-networks provide a tool to enforce compliance by an individual landowner. But the nonpoint source character of the contamination

Resolution of regulatory issues facing the DOE in situ vitrification program

International Nuclear Information System (INIS)

Corathers, L.A.

1992-03-01

In situ vitrification (ISV) is being developed by researchers at the Pacific Northwest Laboratory (PNL), Idaho National Engineering Laboratory (INEL), and Oak Ridge National Laboratory (ORNL) as a technology for remediating soils, underground storage tank residuals, and buried materials that have been contaminated with hazardous, radioactive, and mixed wastes (i.e., wastes containing both radioactive and hazardous wastes) at US Department of Energy (DOE) facilities. The goal of the DOE ISV technology development program (i.e., the ISV Integrated Program) is to ensure that ISV is a workable technology for environmental restoration applications for DOE and other agencies. A DOE complex-wide plan was prepared during Fiscal Year 1991 to coordinate all levels of activities associated with the deployment of ISV. As part of this plan, a programmatic regulatory strategy was developed which focused on the federal environmental, health, safety, and nuclear regulations, including the US Environmental Protection Agency (EPA) and DOE regulations, believed to have the most significant near-term impact on the use of ISV as a remediation technology. The portion of the programmatic regulatory strategy addressing compliance with the Comprehensive Environmental Response, Compensation and Liability Act, as amended, and the Resource Conservation and Recovery Act, as amended, is presented in this paper

Workshop on Regulatory Review and Safety Assessment Issues in Repository Licensing

Energy Technology Data Exchange (ETDEWEB)

Wilmot, Roger D. (Galson Sciences Limited (United Kingdom))

2011-02-15

The workshop described here was organised to address more general issues regarding regulatory review of SKB's safety assessment and overall review strategy. The objectives of the workshop were: - to learn from other programmes' experiences on planning and review of a license application for a nuclear waste repository, - to offer newly employed SSM staff an opportunity to learn more about selected safety assessment issues, and - to identify and document recommendations and ideas for SSM's further planning of the licensing review

Japan's regulatory and safety issues regarding nuclear materials transport

Energy Technology Data Exchange (ETDEWEB)

Saito, T. [Nuclear and Industrial Safety Agency, Ministry of Economy, Trade and Industry, Government of Japan, Tokyo (Japan); Yamanaka, T. [Japan Nuclear Energy Safety Organization, Government of Japan, Tokyo (Japan)

2004-07-01

This paper focuses on the regulatory and safety issues on nuclear materials transport which the Government of Japan (GOJ) faces and needs to well handle. Background information about the status of nuclear power plants (NPP) and nuclear fuel cycle (NFC) facilities in Japan will promote a better understanding of what this paper addresses.

Selected legal and institutional issues related to Ocean Thermal Energy Conversion (OTEC) development

Energy Technology Data Exchange (ETDEWEB)

Nanda, V. P.

1979-06-01

Ocean Thermal Energy Conversion (OTEC), an attractive alternative to traditional energy sources, is still in the early stages of development. To facilitate OTEC commercialization, it is essential that a legal and institutional framework be designed now so as to resolve uncertainties related to OTEC development, primarily involving jurisdictional, regulatory, and environmental issues. The jurisdictional issues raised by OTEC use are dependent upon the site of an OTEC facility and its configuration; i.e., whether the plant is a semipermanent fixture located offshore or a migrating plant ship that provides a source of energy for industry at sea. These issues primarily involve the division of authority between the Federal Government and the individual coastal states. The regulatory issues raised are largely speculative: they involve the adaptation of existing mechanisms to OTEC operation. Finally, the environmental issues raised center around compliance with the National Environmental Policy Act (NEPA) as well as international agreements. 288 references.

Bringing a probiotic-containing functional food to the market: microbiological, product, regulatory and labeling issues.

Science.gov (United States)

Sanders, M E; Huis in't Veld, J

1999-01-01

Properly formulated probiotic-containing foods offer consumers a low risk, low cost dietary component that has the potential to promote health in a variety of ways. Several such products are available commercially, although markets in Japan and Europe are more developed than in the USA. Once healthful attributes of a probiotic product have been identified, there remain microbiological, product, regulatory and labeling issues to be addressed prior to marketing. Microbiological and product issues include safety, effective scale-up for manufacturing, definition of probiotic activity, probiotic stability in the product over the course of product manufacture, shelf-life and consumption, definition of effective dose and target population(s), and development of quality assurance approaches. Examples of probiotic-containing foods are given. Regulatory and labeling issues are complicated because they differ for each country, but are likewise critical because they provide the means for communication of the product benefits to the consumer. The regulatory climate worldwide appears to be one of caution about overstating the benefits of such products but at the same time not preventing corporate commitment to marketing.

Regulatory issues for Waste Isolation Pilot Plant long-term compliance with U.S. Environmental Protection Agency 40 CFR 191B and 268

International Nuclear Information System (INIS)

Anderson, D.R.; Marietta, M.G.; Higgins, P.J. Jr.

1993-10-01

Before disposing of transuranic radioactive waste at the Waste Isolation Pilot Plant (WIPP), the United States Department of Energy (DOE) must evaluate compliance with long-term regulations of the United States Environmental Protection Agency (EPA), specifically the Environmental Standards for the Management and Disposal of Spent Nuclear Fuel, High-Level and Transuranic Radioactive Wastes (40 CFR 191), and the Land Disposal Restrictions (40 CFR 268) of the Hazardous and Solid Waste Amendments to the Resource Conservation and Recovery Act (RCRA). Sandia National Laboratories (SNL) is conducting iterative performance assessments (PAs) of the WIPP for the DOE to provide interim guidance while preparing for final compliance evaluations. This paper provides background information on the regulations, describes the SNL WIPP PA Departments approach to developing a defensible technical basis for consistent compliance evaluations, and summarizes the major observations and conclusions drawn from the 1991 and 1992 PAs

Directory of Certificates of Compliance for Radioactive-Materials Packages. Certificates of Compliance

International Nuclear Information System (INIS)

1983-01-01

This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume I), all Certificates of Compliance (Volume 2), and Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective December 31, 1982. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the back of Volumes 1 and 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Summary Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

Federal and state regulatory requirements for decontamination and decommissioning at US Department of Energy Oak Ridge Operations Facilities

International Nuclear Information System (INIS)

Etnier, E.L.; Houlberg, L.M.; Bock, R.E.

1994-06-01

The purpose of this report is to address regulatory requirements for decontamination and decommissioning (D and D) activities at the Oak Ridge Reservation and Paducah Gaseous Diffusion Plant. This report is a summary of potential federal and state regulatory requirements applicable to general D and D activities. Excerpts are presented in the text and tables from the complete set of regulatory requirements. This report should be used as a guide to the major regulatory issues related to D and D. Compliance with other federal, state, and local regulations not addressed here may be required and should be addressed carefully by project management on a site-specific basis. The report summarizes the major acts and implementing regulations (e.g., Resource and Conservation Recovery Act, Clean Air Act, and Toxic Substances Control Act) only with regard to D and D activities. Additional regulatory drivers for D and D activities may be established through negotiated agreements, such as the Federal Facility Agreement and the US Environmental Protection Agency Mixed Waste Federal Facility Compliance Agreement; these are discussed in this report. The DOE orders and Energy Systems procedures also are summarized briefly in instances where they directly apply to D and D

Reversibility of Decisions and Retrievability of Radioactive Waste: An Overview of Regulatory Positions and Issues

International Nuclear Information System (INIS)

Ruiz-Lopez, Carmen; Pescatore, Claudio

2015-02-01

The Radioactive Waste Management Committee (RWMC) of the NEA has been at the forefront worldwide in examining the topic of Reversibility and Retrievability (R and R). As early as 2001, an NEA survey-based report entitled 'Reversibility and Retrievability in Geological Disposal of Radioactive Waste' provided an overview of R and R by an ad-hoc group of experts from 11 NEA Member countries. The 2001 report (NEA 2001) observed that national safety regulations dealt mainly with operational safety and design targets for long-term (post-closure) safety and relatively little consideration was given to retrievability/reversibility or its implications. Yet, policy frames saw benefits from retrievability. In 2007, the RWMC launched the NEA R and R project with participation from 15 countries and two international organisations. The project included, amongst its members, representatives of six organisations involved in regulation, five regulatory authorities of five countries and one technical support organisation to the safety authorities. The project aimed to improve awareness amongst the RWMC constituency of the breadth of issues and positions regarding the concepts of R and R with the goal of providing a neutral overview of relevant issues and viewpoints in OECD countries. Hence substantial attention was given to R and R regulatory issues mainly in the context of decision making for repository development. The report (NEA 2011) points out regulatory issues, including safety criteria and licensing considerations. The present document presents an overview of findings, positions, boundary conditions and issues based on the results of the R and R project of 2007-2011 (stepwise decision making and reversibility, regulatory authorisations and R and R, decision making for retrieval) and of the Reims conference of December 2010 (terminology and definitions, legal and policy context, motivations for R and R, practical aspects, stakeholders confidence aspects)

Information system fur the management of a regulatory programme

International Nuclear Information System (INIS)

Ortiz, P.; Mrabit, K.; Miaw, S.

1998-01-01

A Regulatory Programme to monitor safety of activities involving radiation sources, implies the existence of a Regulatory Authority empowered by legislation to issue radiation protection regulations and to monitor compliance with those regulations. The core element of the programme is a system of notification and authorization (registration and licensing), inspection and enforcement. The efficiency of this system is largely dependent on the availability of reliable information on the inventory of radiation sources and installations, the administrative status of the facilities (authorization), prompt processing of inspection reports and follow up of regulatory actions, including monitoring deadlines. Essential data relevant to safety, such as personal dosimetry for occupationally exposed individuals, inspection findings and incident reports would provide, in addition, an insight on the overall safety of the country. A simple but comprehensive Regulatory Authority Information System (RAIS) linked to the authorization and inspection process will largely facilitate regulatory decisions and actions. A readily available and reliable information from the various regulatory activities will facilitate planning, optimization of resources, monitoring safety related data, disseminating safety information, making decisions and follow up regulatory actions including monitoring dead lines. The implementation of the system in more than 50 countries will contribute to experience exchange and harmonization of regulatory activities. (author)

76 FR 57006 - Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX; NRC Regulation of...

Science.gov (United States)

2011-09-15

... NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30 and 150 [NRC-2011-0146] Proposed Generic Communications; Draft NRC Regulatory Issue Summary 2011-XX; NRC Regulation of Military Operational Radium-226... published for public comment the proposed draft RIS 2011-XX; NRC Regulation of Military Operational Radium...

Why Chinese farmers obey the law: Pesticide compliance in Hunan Province, China

NARCIS (Netherlands)

Yan, H.

2014-01-01

While China’s legal system has been increasingly perfected, the implementation of laws in China remains challenging. Simply strengthening law enforcement is not sufficient to improve compliance. It is necessary to bring in a regulatory compliance perspective. This book intends to explore compliance

Regulatory requirements related to maintenance and compliance monitoring

International Nuclear Information System (INIS)

Ling, A.K.H.

1997-01-01

The maintenance related regulatory requirements are identified in the regulatory documents and licence conditions. Licensee complies with these requirements by operating the nuclear power plant within the safe operating envelope as given in the operating policies and principles and do maintenance according to approved procedures and/or work plans. Safety systems are regularly tested. AECB project officers review and check to ensure that the licensee operates the nuclear power plant in accordance with the regulatory requirements and licence conditions. (author). 6 tabs

Directory of certificates of compliance for radioactive materials packages. Volume 2. Certificates of compliance

International Nuclear Information System (INIS)

1977-12-01

Purpose of this directory is to make available a convenient source of information on packagings which have been approved by the U.S. Nuclear Regulatory Commission. This volume contains all certificates of compliance for radioactive material packages effective Nov. 30, 1977

Business process compliance checking : current state and future challenges

NARCIS (Netherlands)

El Kharbili, M.; Alves De Medeiros, A.K.; Stein, S.; Aalst, van der W.M.P.; Loos, P.; Nüttgens, M.; Turowski, K.; Werth, D.

2008-01-01

Regulatory compliance sets new requirements for business process management (BPM). Companies seek to enhance their corporate governance processes and are required to put in place measures for ensuring compliance to regulations. In this sense, this position paper (i) reviews the current work in the

A study on the regulatory approach of major technical issues

Energy Technology Data Exchange (ETDEWEB)

Chang, Keun Sun; Oh, S. H.; Kang, H. J.; Kim, G. S. [Sunmoon Univ., Asan (Korea, Republic of); Lee, S. H.; Baek, W. P.; Yang, S. H.; Jeong, Y. H. [Korea Association for Nuclear Technology, Taejon (Korea, Republic of)

1999-02-15

This project is to provide the regulatory direction of 4 major technical issues for the Korean Next Generation Reactors, which are parts of major technical issues resulted from the safety regulation R and D on the KNGR. The outstanding results are are as follows : related to the classification and acceptance criteria of plant conditions, currently used classification and safety requirement were reviewed and regulatory direction was proposed. Among multiple failures, it is identified that SBO, TLOFW, multiple SGTR and ATWS are basically to be considered for additional requirements for advanced reactors. This study reviewed risk aspects, design consideration, and trends of safety requirements, and proposed fundamental safety requirements to be applied for KNGR. Multiple steam generator tube failure is a significant safety concern because of the possibility of release of radionuclides to the environment through containment bypass. Proposed safety requirement for this event can be categorized mainly as analysis requirement, design evaluation requirement and PSA requirement; For protection of containment failure, a reasonable safety position is necessary through and integrated review of possibility of severe accident occurrence, effects of sever accident mitigation features and cost effects of these design features. With this consideration safety requirements developed are the analysis requirement, provision of protective measures and survivability/availability of protective measures.

Environmental Regulatory Compliance Plan for Site Characterization; Yucca Mountain Site, Nevada Research and Development Area, Nevada: Revision 1

Energy Technology Data Exchange (ETDEWEB)

NONE

1988-12-01

The DOE is committed to conduct its operations in an environmentally safe and sound manner, and will comply with applicable environmental statutes and regulations. These objectives are described in DOE Order 5400.1 (Environmental Protection Program Requirements). This document -- the Environmental Regulatory Compliance Plan (ERCP) -- is one method of implementing the policy set forth in DOE Order 5400.1 and the NWPA. The ERCP describes the plan by which the DOE will comply with applicable Federal environmental statutes and regulations. The ERCP also discusses how DOE will address State and local environmental statutes and regulations. 180 refs., 27 figs., 1 tab.

Anatomy of a cogeneration deal : natural gas contracts and regulatory issues

International Nuclear Information System (INIS)

Brett, J.T.

1999-01-01

The special features of gas contracts for cogeneration projects were discussed. It was recommended that a gas power purchase contract should be entered early in a project development cycle to justify requests for new pipeline facilities. Issues regarding buyer's commitments, market prices, and volumes were also discussed. In the event of failure to deliver, the contract should include provisions which would make it possible to source gas elsewhere, terminate the contract or seek damages. This paper also discussed various pricing provisions in a gas commodity contract, security of supplies, gas transportation arrangements, regulatory considerations, outstanding issues, and IMO (independent market operator) requirements

Compliance with air quality regulations

International Nuclear Information System (INIS)

Steen, D.V.; Tackett, D.L.

1990-01-01

Due to the probable passage of Clean Air Act Amendments in 1990, electric utilities throughout the United States are faced with numerous choices to comply with the new acid rain regulations, expected in 1991. The choice of a compliance plan is not a simple task. Every compliance option will be costly. At Ohio Edison, deliberations are quite naturally influenced by past compliance with air quality regulations. This paper discusses compliance with air quality regulations in the 1970's, clean coal technologies and advanced scrubbers, and compliance with air quality regulations in 1995 - 2000. The choice of a compliance strategy for many utilities will involve serving customer loads through some combination of scrubbers, clean coal technologies, fuel switching, fuel blending, redispatch of units, and emissions trading. Whatever the final choice, it must be economic while providing sufficient flexibility to accommodate the critical uncertainties of load growth, state regulatory treatment, markets for emission allowances, advancements in control technologies, additional federal requirements for air emissions, equipment outages and fuel supply disruptions.s

Managing business compliance using model-driven security management

Science.gov (United States)

Lang, Ulrich; Schreiner, Rudolf

Compliance with regulatory and governance standards is rapidly becoming one of the hot topics of information security today. This is because, especially with regulatory compliance, both business and government have to expect large financial and reputational losses if compliance cannot be ensured and demonstrated. One major difficulty of implementing such regulations is caused the fact that they are captured at a high level of abstraction that is business-centric and not IT centric. This means that the abstract intent needs to be translated in a trustworthy, traceable way into compliance and security policies that the IT security infrastructure can enforce. Carrying out this mapping process manually is time consuming, maintenance-intensive, costly, and error-prone. Compliance monitoring is also critical in order to be able to demonstrate compliance at any given point in time. The problem is further complicated because of the need for business-driven IT agility, where IT policies and enforcement can change frequently, e.g. Business Process Modelling (BPM) driven Service Oriented Architecture (SOA). Model Driven Security (MDS) is an innovative technology approach that can solve these problems as an extension of identity and access management (IAM) and authorization management (also called entitlement management). In this paper we will illustrate the theory behind Model Driven Security for compliance, provide an improved and extended architecture, as well as a case study in the healthcare industry using our OpenPMF 2.0 technology.

Regulatory analysis for resolution of USI [Unresolved Safety Issue] A-47

International Nuclear Information System (INIS)

Szukiewicz, A.J.

1989-07-01

This report presents a summary of the regulatory analysis conducted by the US Nuclear Regulatory Commission staff to evaluate the value/impact of alternatives for the resolution of Unresolved Safety Issue A-47, ''Safety Implications of Control Systems.'' The NRC staff's resolution presented herein is based on these analyses and on the technical findings and conclusions presented in NUREG-1217, the companion document to this report. The staff has concluded that certain actions should be taken to improve safety in light-water reactor plants. The staff recommended that certain plants improve their control systems to preclude reactor vessel/steam generator overfill events and to prevent steam generator dryout, modify their technical specifications to verify operability of such systems, and modify selected emergency procedures to ensure safe shutdown of the plant following a small-break loss-of-coolant accident. This report was issued as a draft for public comment on May 27, 1988. As a result of the public comments received, this report was revised. The NRC staff's responses to and resolution of the public comments are included as Appendix C to the final report, NUREG-1217

How it can assist in compliance with the DOE`S new 10 CFR 835 and the NRC`S 10 CFR 20 regulation

Energy Technology Data Exchange (ETDEWEB)

Bailey, W.H. [NFS Radiation Protection Systems, Inc., Erwin, TN (United States)

1995-02-01

With new government regulations on the horizon, advanced technology will become a necessity for the accurate assessment of air sampling data and maintaining internal dose ALARA. Bar coding is one advanced technology which has provided significant improvements in radiological air sampling. When combined with specific hardware and software, bar code technology can be used to automate procedures and enhance the data accuracy associated with air sampling in the workplace. This paper discusses some of the regulatory issues regarding radiological air sampling and describes how improved bar coded accountability techniques can assist in regulatory compliance.

Regulatory and institutional issues for development of remedial action strategies at ORNL

International Nuclear Information System (INIS)

Kocher, D.C.

1988-01-01

This paper discusses a number of unresolved regulatory and institutional issues of fundamental importance to the development of strategies for cleanup of sites contaminated by the radioactive materials at Oak Ridge National Laboratory. These issues include the development of criteria for limiting radiation exposures of the public from remedial action sites, the time period to be assumed for active institutional controls over contaminated sites and the location at which such controls will be maintained, and the applicability of current standards for radioactivity in drinking water to surface waters and ground waters on the Oak Ridge Reservation. Proposals for resolution of these issues emphasize the need to protect public health, but in a cost-effective manner. 21 refs

Compliance Function in Banks, Investment and Insurance Companies after MiFID

OpenAIRE

Musile Tanzi, Paola; Gabbi, Giampaolo; Previati, Daniele; Schwizer, Paola

2010-01-01

The risk of compliance comes from the failure to comply with laws, regulations, rules, self-regulatory standards, and codes of conduct. This article focuses on the evolving scenario of the compliance function within banks, investment and insurance companies operating in Italy. We developed four areas of research questions: (i) Does the positioning of the compliance function in the organizational structure start “at the top”? (ii) Are roles attributed to the compliance ...

Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis

Energy Technology Data Exchange (ETDEWEB)

MULKEY, C.H.

1999-07-06

This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through the DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues. This document does not address health or safety regulations or requirements (those of the Occupational Safety and Health Administration or the National Institute of Occupational Safety and Health) or continuous emission monitoring systems. This DQO is applicable to all equipment, facilities, and operations under the jurisdiction of RPP that emit or have the potential to emit regulated air pollutants.

Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis

International Nuclear Information System (INIS)

MULKEY, C.H.

1999-01-01

This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through the DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues. This document does not address health or safety regulations or requirements (those of the Occupational Safety and Health Administration or the National Institute of Occupational Safety and Health) or continuous emission monitoring systems. This DQO is applicable to all equipment, facilities, and operations under the jurisdiction of RPP that emit or have the potential to emit regulated air pollutants

Patient compliance in hypertension: role of illness perceptions and treatment beliefs.

Science.gov (United States)

Ross, S; Walker, A; MacLeod, M J

2004-09-01

Despite many years of study, questions remain about why patients do or do not take medicines and what can be done to change their behaviour. Hypertension is poorly controlled in the UK and poor compliance is one possible reason for this. Recent questionnaires based on the self-regulatory model have been successfully used to assess illness perceptions and beliefs about medicines. This study was designed to describe hypertensive patients' beliefs about their illness and medication using the self-regulatory model and investigate whether these beliefs influence compliance with antihypertensive medication. We recruited 514 patients from our secondary care population. These patients were asked to complete a questionnaire that included the Beliefs about Medicines and Illness Perception Questionnaires. A case note review was also undertaken. Analysis shows that patients who believe in the necessity of medication are more likely to be compliant (odds ratio (OR)) 3.06 (95% CI 1.74-5.38), Pcompliance influence it indirectly. The self-regulatory model is useful in assessing patients health beliefs. Beliefs about specific medications and about hypertension are predictive of compliance. Information about health beliefs is important in achieving concordance and may be a target for intervention to improve compliance.

International regulatory issues and approaches in the transition phase from operation to decommissioning

International Nuclear Information System (INIS)

Pyy, P.; Hrehor, M.; ); Murley, T.; Ranieri, R.; Laaksonen, J.

2005-01-01

Full text: The paper summarizes the work performed by an international group of senior nuclear safety regulators which was convened by the Committee on Nuclear Regulatory Activities (CNRA) of the OECD/Nuclear Energy Agency. The fundamental objective of this work was to identify the safety, environmental, organizational, human factors and public policy issues arising from decommissioning that will produce new challenges for the regulator. The study begins by recognizing that decommissioning is not simply an extension of operation and thus it is important for both the management of the facility and the regulator to understand the fundamental nature of the change taking place. Major regulatory policy issues discussed during this study include assurance of adequate funds, waste storage and disposal sites, material release criteria and site release criteria. Some of the important regulatory challenges relate to organizational and human factors, to safety and security requirements and to waste disposal and license termination. The importance of regular communication with both the corporate and site management and with public is recognized in the study as one of the key factors. When a nuclear facility ceases operation and enters into the decommissioning phase, both the operator and the regulator face a new set of challenges very different from those of an operating facility. The operator should have in place a strategic plan for decommissioning, prepared well in advance and reviewed by the regulatory body, to guide the facility managers and personnel through the changed circumstances. An essential part of the strategic plan should be the operator's plan for securing adequate funds to complete the decommissioning activities. In fact, the regulator should ensure that the operator sets aside funds, perhaps in a trust fund, while the facility is still operating and generating revenues. Both the operator and the regulator should expect a heightened public interest and concern

Regulatory assessment of safety culture in nuclear organisations - current trends and challenges

International Nuclear Information System (INIS)

Tronea, M.

2010-01-01

The paper gives an overview of the current practices in the area of regulatory assessment of safety culture in nuclear organisations and of the associated challenges. While the assessment and inspection procedures currently in use by regulatory authorities worldwide are directed primarily at verifying compliance with the licensing basis, there is a recognised need for a more systematic approach to the identification, collection and review of data relevant to the safety culture in licensees' organisations. The paper presents a proposal for using the existing regulatory inspection practices for gathering information relevant to safety culture and for assessing it in an integrated manner. The proposal is based on the latest requirements and guidance issued by the International Atomic Energy Agency (IAEA) on management systems for nuclear facilities and activities, particularly as regards the attributes needed for a strong nuclear safety culture. (author)

Environmental compliance and cleanup

Energy Technology Data Exchange (ETDEWEB)

Black, D.G.

1995-06-01

This section of the 1994 Hanford Site Environmental Report summarizes the roles of the principal agencies, organizations, and public in environmental compliance and cleanup of the Hanford Site. Regulatory oversight, the Federal Facility Agreement and Consent Order, the role of Indian tribes, public participation, and CERCLA Natural Resource Damage Assessment Trustee Activities are all discussed.

Environmental compliance and cleanup

International Nuclear Information System (INIS)

Black, D.G.

1995-01-01

This section of the 1994 Hanford Site Environmental Report summarizes the roles of the principal agencies, organizations, and public in environmental compliance and cleanup of the Hanford Site. Regulatory oversight, the Federal Facility Agreement and Consent Order, the role of Indian tribes, public participation, and CERCLA Natural Resource Damage Assessment Trustee Activities are all discussed

75 FR 78155 - Uniform Compliance Date for Food Labeling Regulations

Science.gov (United States)

2010-12-15

.... FDA-2000-N-0011] Uniform Compliance Date for Food Labeling Regulations AGENCY: Food and Drug... 1, 2014, as the uniform compliance date for food labeling regulations that are issued between... established January 2, 2012, as the uniform compliance date for food labeling regulations issued between...

Site-Specific Analyses for Demonstrating Compliance with 10 CFR 61 Performance Objectives - 12179

Energy Technology Data Exchange (ETDEWEB)

Grossman, C.J.; Esh, D.W.; Yadav, P.; Carrera, A.G. [U.S. Nuclear Regulatory Commission, 11545 Rockville Pike, Rockville, MD 20852 (United States)

2012-07-01

The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations at 10 CFR Part 61 to require low-level radioactive waste disposal facilities to conduct site-specific analyses to demonstrate compliance with the performance objectives in Subpart C. The amendments would require licensees to conduct site-specific analyses for protection of the public and inadvertent intruders as well as analyses for long-lived waste. The amendments would ensure protection of public health and safety, while providing flexibility to demonstrate compliance with the performance objectives, for current and potential future waste streams. NRC staff intends to submit proposed rule language and associated regulatory basis to the Commission for its approval in early 2012. The NRC staff also intends to develop associated guidance to accompany any proposed amendments. The guidance is intended to supplement existing low-level radioactive waste guidance on issues pertinent to conducting site-specific analyses to demonstrate compliance with the performance objectives. The guidance will facilitate implementation of the proposed amendments by licensees and assist competent regulatory authorities in reviewing the site-specific analyses. Specifically, the guidance provides staff recommendations on general considerations for the site-specific analyses, modeling issues for assessments to demonstrate compliance with the performance objectives including the performance assessment, intruder assessment, stability assessment, and analyses for long-lived waste. This paper describes the technical basis for changes to the rule language and the proposed guidance associated with implementation of the rule language. The NRC staff, per Commission direction, intends to propose amendments to 10 CFR Part 61 to require licensees to conduct site-specific analyses to demonstrate compliance with performance objectives for the protection of public health and the environment. The amendments would require a

The Engineering Compliance Program development process and its role in design

International Nuclear Information System (INIS)

1997-12-01

This paper presents an overview of the Engineering Compliance Program (ECP) development process and its role in design. The ECP is a formal program to assess Nuclear Regulatory Commission (NRC) regulatory guidance in terms of precedence, industry experience documents, and codes and standards to determine their applicability to Mined Geologic Disposal System (MGDS) design. These determinations are documented in ECP Guidance Packages for MGDS Structures, Systems and Components (SSCs). This ensures that the license application appropriately reflects the MGDS design and facilitates NRC acceptance and compliance review

77 FR 70885 - Uniform Compliance Date for Food Labeling Regulations

Science.gov (United States)

2012-11-28

.... FDA-2000-N-0011] Uniform Compliance Date for Food Labeling Regulations AGENCY: Food and Drug... January 1, 2016, as the uniform compliance date for food labeling regulations that are issued between... established January 1, 2014, as the uniform compliance date for food labeling regulations issued between...

Waste Isolation Pilot Plant Biennial Environmental Compliance Report

Energy Technology Data Exchange (ETDEWEB)

Washington Regulatory and Environmental Services (WRES)

2004-10-25

This Biennial Environmental Compliance Report (BECR) documents environmental regulatory compliance at the Waste Isolation Pilot Plant (WIPP), a facility designed and authorized for the safe disposal of transuranic (TRU) radioactive waste, for the reporting period of April 1, 2002, to March 31, 2004. As required by the WIPP Land Withdrawal Act (LWA) (Public Law [Pub. L.] 102-579, as amended by Pub. L. 104-201), the BECR documents U.S. Department of Energy (DOE) compliance with applicable environmental protection laws and regulations implemented by agencies of the federal government and the state of New Mexico.

Waste Isolation Pilot Plant Biennial Environmental Compliance Report

International Nuclear Information System (INIS)

2004-01-01

This Biennial Environmental Compliance Report (BECR) documents environmental regulatory compliance at the Waste Isolation Pilot Plant (WIPP), a facility designed and authorized for the safe disposal of transuranic (TRU) radioactive waste, for the reporting period of April 1, 2002, to March 31, 2004. As required by the WIPP Land Withdrawal Act (LWA) (Public Law [Pub. L.] 102-579, as amended by Pub. L. 104-201), the BECR documents U.S. Department of Energy (DOE) compliance with applicable environmental protection laws and regulations implemented by agencies of the federal government and the state of New Mexico.

License Compliance Issues For Biopharmaceuticals: Special Challenges For Negotiations Between Companies And Non-Profit Research Institutions

Science.gov (United States)

Ponzio, Todd A.; Feindt, Hans; Ferguson, Steven

2011-01-01

monitor the licensee’s diligence and progress; most exclusive licenses include a commercial development plan, with penalties, financial or even revocation of the license, if the plan is not followed, e.g., the license falls too far behind. This study examines whether developmental milestone schedules based on a small molecule drug development model are useful and realistic in setting expectations for biopharmaceutical product development. We reviewed the monitoring records of all exclusive Public Health Service (PHS) commercial development license agreements for small molecule drugs or therapeutics based on biotechnology (biopharmaceuticals) executed by the National Institutes of Health (NIH) Office of Technology Transfer (OTT) between 2003 and 2009. We found that most biopharmaceutical development license agreements required amending because developmental milestones in the negotiated schedule could not be met by the licensee. This was in stark contrast with license agreements for small molecule chemical compounds which rarely needed changes to their developmental milestone schedules. As commercial development licenses for biopharmaceuticals make up the vast majority of NIH’s exclusive license agreements, there is clearly a need to: 1) more closely examine how these benchmark schedules are formed, 2) try to understand the particular risk factors contributing to benchmark schedule non-compliance, and 3) devise alternatives to the current license benchmark schedule structural model. Schedules that properly weigh the most relevant risk factors such as technology classification (e.g., vaccine vs recombinant antibody vs gene therapy), likelihood of unforeseen regulatory issues, and company size/structure may help assure compliance with original license benchmark schedules. This understanding, coupled with a modified approach to the license negotiation process that makes use of a clear and comprehensive term sheet to minimize ambiguities should result in a more realistic

License Compliance Issues For Biopharmaceuticals: Special Challenges For Negotiations Between Companies And Non-Profit Research Institutions.

Science.gov (United States)

Ponzio, Todd A; Feindt, Hans; Ferguson, Steven

2011-09-01

the licensee's diligence and progress; most exclusive licenses include a commercial development plan, with penalties, financial or even revocation of the license, if the plan is not followed, e.g., the license falls too far behind.This study examines whether developmental milestone schedules based on a small molecule drug development model are useful and realistic in setting expectations for biopharmaceutical product development. We reviewed the monitoring records of all exclusive Public Health Service (PHS) commercial development license agreements for small molecule drugs or therapeutics based on biotechnology (biopharmaceuticals) executed by the National Institutes of Health (NIH) Office of Technology Transfer (OTT) between 2003 and 2009. We found that most biopharmaceutical development license agreements required amending because developmental milestones in the negotiated schedule could not be met by the licensee. This was in stark contrast with license agreements for small molecule chemical compounds which rarely needed changes to their developmental milestone schedules. As commercial development licenses for biopharmaceuticals make up the vast majority of NIH's exclusive license agreements, there is clearly a need to: 1) more closely examine how these benchmark schedules are formed, 2) try to understand the particular risk factors contributing to benchmark schedule non-compliance, and 3) devise alternatives to the current license benchmark schedule structural model. Schedules that properly weigh the most relevant risk factors such as technology classification (e.g., vaccine vs recombinant antibody vs gene therapy), likelihood of unforeseen regulatory issues, and company size/structure may help assure compliance with original license benchmark schedules. This understanding, coupled with a modified approach to the license negotiation process that makes use of a clear and comprehensive term sheet to minimize ambiguities should result in a more realistic benchmark

Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis; FINAL

International Nuclear Information System (INIS)

MULKEY, C.H.

1999-01-01

This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through the DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues. This document does not address health or safety regulations or requirements (those of the Occupational Safety and Health Administration or the National Institute of Occupational Safety and Health) or continuous emission monitoring systems. This DQO is applicable to all equipment, facilities, and operations under the jurisdiction of RPP that emit or have the potential to emit regulated air pollutants

Compliance assurance for the safe transport of radioactive material

International Nuclear Information System (INIS)

1994-01-01

The purpose of this book is to assist competent authorities in the development and maintenance of compliance assurance programmes in connection with the transport of radioactive material, and to assist applicants, licensees and organizations in their interactions, with competent authorities. In order to increase co-operation between competent authorities and to promote uniform application of international regulations and recommendations it is desirable to adopt a common approach to regulatory activities. This book is intended to assist in accomplishing such uniform application by laying down most of the actions that competent authorities need to provide for in their programmes for ensuring regulatory compliance. 23 refs, figs and tabs

77 FR 65417 - Compliance With Information Request, Flooding Hazard Reevaluation

Science.gov (United States)

2012-10-26

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0261] Compliance With Information Request, Flooding Hazard... flooding hazard reanalysis in response to enclosure 2 of a March 12, 2012, information request. DATES... evaluation of whether further regulatory action was needed in the areas of seismic and flooding design, and...

Regulatory inspection of BARC facilities

International Nuclear Information System (INIS)

Rajdeep; Jayarajan, K.

2017-01-01

Nuclear and radiation facilities are sited, constructed, commissioned, operated and decommissioned, in conformity with the current safety standards and codes. Regulatory bodies follow different means to ensure compliance of the standards for the safety of the personnel, the public and the environment. Regulatory Inspection (RI) is one of the important measures employed by regulatory bodies to obtain the safety status of a facility or project and to verify the fulfilment of the conditions stipulated in the consent

75 FR 27772 - Corning Natural Gas Corporation; Notice of Compliance Filing

Science.gov (United States)

2010-05-18

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR09-30-002] Corning Natural Gas Corporation; Notice of Compliance Filing May 11, 2010. Take notice that on May 3, 2010, Corning Natural Gas Corporation, (Corning) filed its Statement of section 311 Operating Conditions in compliance...

Key regulatory and safety issues emerging NEA activities. Lessons Learned from Fukushima Dai-ichi NPS Accident - Key Regulatory and Safety Issues

International Nuclear Information System (INIS)

Nakoski, John

2013-01-01

A presentation was provided on the key safety and regulatory issues and an update of activities undertaken by the NEA and its members in response to the accident at the Fukushima Daiichi nuclear power stations (NPS) on 11 March 2011. An overview of the accident sequence and the consequences was provided that identified the safety functions that were lost (electrical power, core cooling, and primary containment) that lead to units 1, 2, and 3 being in severe accident conditions with large off-site releases. Key areas identified for which activities of the NEA and member countries are in progress include accident management; defence-in-depth; crisis communication; initiating events; operating experience; deterministic and probabilistic assessments; regulatory infrastructure; radiological protection and public health; and decontamination and recovery. For each of these areas, a brief description of the on-going and planned NEA activities was provided within the three standing technical committees of the NEA with safety and regulatory mandates (the Committee on Nuclear Regulatory Activities - CNRA, the Committee on the Safety of Nuclear Installations - CSNI, and the Committee on Radiation Protection and Public Health - CRPPH). On-going activities of CNRA include a review of enhancement being made to the regulatory aspects for the oversight of on-site accident management strategies and processes in light of the lessons learned from the accident; providing guidance to regulators on crisis communication; and supporting the peer review of the safety assessments of risk-significant research reactor facilities in light of the accident. Within the scope of the CSNI mandate, activities are being undertaken to better understand accident progression; characteristics of new fuel designs; and a benchmarking study of fast-running software for estimating source term under severe accident conditions to support protective measure recommendations. CSNI also has ongoing work in human

Evaluation on safety issues of SMART

International Nuclear Information System (INIS)

Kim, W. S.; Seol, K. W.; Yoon, Y. K.; Lee, J. H.

2001-01-01

Safety issues on the SMART were evaluated in the light of the compliance with the Ministerial Ordinance of Technical Requirements applying to Nuclear Installations, which was recently revised. Evaluation concludes that regulatory requirements associated with following items have to be developed as the licensing criteria for the SMART: (1) proving the safety of design or materials different form existing reactors; (2) coping with beyond design basis accidents; (3) rulemaking on the safety of reactor safeguard vessel ; (4) ensuring integrity of steam generator tubes; and (5) classifying equipment based on their safety significance. Appropriate actions including implementation of new requirements under development should be taken for safety issues such as diversity of reactivity control and in-service inspection of steam generator tubes that are not complied with the current Technical Requirements. Safety level of the SMART design will be evaluated further by the more detailed assessment according to the Technical Requirements, and additional safety issues will be identified and resolved, if it necessary

Suggested technical scheme to help resolve regulatory issues

Energy Technology Data Exchange (ETDEWEB)

Harvey, T.

1978-07-01

A management-planning model envisioned as a useful tool for planning and guiding the development of a nuclear waste repository data base is described. It incorporates the technical assessment goals and objectives of the US Nuclear Regulatory Commission, and it provides a strategy for reaching them. The model strategy includes provisions for the breadth, timeliness, and defensibility of its predictions. Consideration is given to observational data, its structure, and future refinements. The structure of the data is consistent with the needs of a systems model whose structure is proposed to resolve questions about repository safety. Uncertainties are categorized as an aid in defining and resolving technical issues. The model provides a framework for ultimately exposing all the sensitive and controversial factors. Some quantitative aspects of data acquisition are presented. 12 figures.

Suggested technical scheme to help resolve regulatory issues

International Nuclear Information System (INIS)

Harvey, T.

1978-07-01

A management-planning model envisioned as a useful tool for planning and guiding the development of a nuclear waste repository data base is described. It incorporates the technical assessment goals and objectives of the US Nuclear Regulatory Commission, and it provides a strategy for reaching them. The model strategy includes provisions for the breadth, timeliness, and defensibility of its predictions. Consideration is given to observational data, its structure, and future refinements. The structure of the data is consistent with the needs of a systems model whose structure is proposed to resolve questions about repository safety. Uncertainties are categorized as an aid in defining and resolving technical issues. The model provides a framework for ultimately exposing all the sensitive and controversial factors. Some quantitative aspects of data acquisition are presented. 12 figures

Instream sand and gravel mining: Environmental issues and regulatory process in the United States

Science.gov (United States)

Meador, M.R.; Layher, A.O.

1998-01-01

Sand and gravel are widely used throughout the U.S. construction industry, but their extraction can significantly affect the physical, chemical, and biological characteristics of mined streams. Fisheries biologists often find themselves involved in the complex environmental and regulatory issues related to instream sand and gravel mining. This paper provides an overview of information presented in a symposium held at the 1997 midyear meeting of the Southern Division of the American Fisheries Society in San Antonio, Texas, to discuss environmental issues and regulatory procedures related to instream mining. Conclusions from the symposium suggest that complex physicochemical and biotic responses to disturbance such as channel incision and alteration of riparian vegetation ultimately determine the effects of instream mining. An understanding of geomorphic processes can provide insight into the effects of mining operations on stream function, and multidisciplinary empirical studies are needed to determine the relative effects of mining versus other natural and human-induced stream alterations. Mining regulations often result in a confusing regulatory process complicated, for example, by the role of the U.S. Army Corps of Engineers, which has undergone numerous changes and remains unclear. Dialogue among scientists, miners, and regulators can provide an important first step toward developing a plan that integrates biology and politics to protect aquatic resources.

Traceability and retrievability: Documentation, the bridge from science to compliance

International Nuclear Information System (INIS)

Warner, P.J.

1997-01-01

In this day of regulatory compliance, the fact that good science was practiced and documented is, in and of itself, not enough to assure a successful licensing or permitting result. A new level of documentation, that clearly walks a non-project reviewer through the traceability of all activities and decisions is required for successful acceptance of scientific results. Compliance reviewers (whether the Nuclear Regulatory Commission (NRC), Environmental Protection Agency (EPA), etc.) expect to verify the results of the scientific and program activities without the physical presence of the person or persons that conducted the activity. Traceability of activities and associated decisions through the retrieval of all associated records is a must. This presentation is based on lessons learned from the various quality assurance (QA) audits and program reviews of Sandia National Laboratories, Nuclear Waste Management Programs Center, scientific and programmatic documentation. The authors build a bridge from science to compliance from lessons learned. Here now is a somewhat fictional rendition of actual scientific testing and compliance support activities

Regulatory policy issues and the Clean Air Act: Issues and papers from the state implementation workshops

Energy Technology Data Exchange (ETDEWEB)

Rose, K. [ed.; Burns, R.E.

1993-07-01

The National Regulatory Research Institute (NRRI), with funding from the US Environmental Protection Agency (EPA) and the US Department of Energy (DOE), conducted four regional workshops` on state public utility commission implementation of the Clean Air Act Amendments of 1990 (CAAA). The workshops had four objectives: (1) to discuss key issues and concerns on CAAA implementation, (2) to encourage a discussion among states on issues of common interests, (3) to attempt to reach consensus, where possible, on key issues, and (4) to provide the workshop participants with information and materials to assist in developing state rules, orders, and procedures. From the federal perspective, a primary goal was to ensure that workshop participants return to their states with a comprehensive background and understanding of how state commission actions may affect implementation of the CAAA and to be able to provide guidance to their jurisdictional utilities. It was hoped that this would reduce some of the uncertainty utilities face and assist in the development of an efficient allowance market. This report is divided into two main sections. In Section II, eleven principal issues are identified and discussed. These issues were chosen because they were either the most frequently discussed or they were related to the questions asked in response to the speakers` presentations. This section does not cover all the issues relevant to state implementation nor all the issues discussed at the workshops; rather, Section II is intended to provide an overview of the,planning, ratemaking, and multistate issues. Part III is a series of workshop papers presented by some of the speakers. Individual papers have been cataloged separately.

The regulatory process for uranium mines in Canada -general overview and radiation health and safety in uranium mine-mill facilities

International Nuclear Information System (INIS)

Dory, A.B.

1982-01-01

This presentation is divided into two main sections. In the first, the author explores the issues of radiation and tailings disposal, and then examines the Canadian nuclear regulatory process from the point of view of jurisdiction, objectives, philosophy and mechanics. The compliance inspection program is outlined, and the author discussed the relationships between the AECB and other regulatory agencies, the public and uranium mine-mill workers. The section concludes with an examination of the stance of the medical profession on nuclear issues. In part two, the radiological hazards for uranium miners are examined: radon daughters, gamma radiation, thoron daughters and uranium dust. The author touches on new regulations being drafted, the assessment of past exposures in mine atmospheres, and the regulatory approach at the surface exploration stage. The presentation concludes with the author's brief observations on the findings of other uranium mining inquiries and on future requirements in the industry's interests

Network and Database Security: Regulatory Compliance, Network, and Database Security - A Unified Process and Goal

Directory of Open Access Journals (Sweden)

Errol A. Blake

2007-12-01

Full Text Available Database security has evolved; data security professionals have developed numerous techniques and approaches to assure data confidentiality, integrity, and availability. This paper will show that the Traditional Database Security, which has focused primarily on creating user accounts and managing user privileges to database objects are not enough to protect data confidentiality, integrity, and availability. This paper is a compilation of different journals, articles and classroom discussions will focus on unifying the process of securing data or information whether it is in use, in storage or being transmitted. Promoting a change in Database Curriculum Development trends may also play a role in helping secure databases. This paper will take the approach that if one make a conscientious effort to unifying the Database Security process, which includes Database Management System (DBMS selection process, following regulatory compliances, analyzing and learning from the mistakes of others, Implementing Networking Security Technologies, and Securing the Database, may prevent database breach.

Draft Title 40 CFR 191 compliance certification application for the Waste Isolation Pilot Plant. Volume 1

International Nuclear Information System (INIS)

1995-01-01

The Waste Isolation Pilot Plant (WIPP) is a research and development facility for the demonstration of the permanent isolation of transuranic radioactive wastes in a geologic formation. The facility was constructed in southeastern New Mexico in a manner intended to meet criteria established by the scientific and regulatory community for the safe, long-term disposal of transuranic wastes. The US Department of Energy (DOE) is preparing an application to demonstrate compliance with the requirements outlined in Title 40, Part 191 of the Code of Federal Regulations (CFR) for the permanent disposal of transuranic wastes. As mandated by the Waste Isolation Pilot Plant (WIPP) Land Withdrawal Act of 1992, the US Environmental Protection Agency (EPA) must evaluate this compliance application and provide a determination regarding compliance with the requirements within one year of receiving a complete application. Because the WIPP is a very complex program, the DOE has planned to submit the application as a draft in two parts. This strategy will allow for the DOE and the EPA to begin technical discussions on critical WIPP issues before the one-year compliance determination period begins. This report is the first of these two draft submittals

Draft Title 40 CFR 191 compliance certification application for the Waste Isolation Pilot Plant. Volume 1

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-03-31

The Waste Isolation Pilot Plant (WIPP) is a research and development facility for the demonstration of the permanent isolation of transuranic radioactive wastes in a geologic formation. The facility was constructed in southeastern New Mexico in a manner intended to meet criteria established by the scientific and regulatory community for the safe, long-term disposal of transuranic wastes. The US Department of Energy (DOE) is preparing an application to demonstrate compliance with the requirements outlined in Title 40, Part 191 of the Code of Federal Regulations (CFR) for the permanent disposal of transuranic wastes. As mandated by the Waste Isolation Pilot Plant (WIPP) Land Withdrawal Act of 1992, the US Environmental Protection Agency (EPA) must evaluate this compliance application and provide a determination regarding compliance with the requirements within one year of receiving a complete application. Because the WIPP is a very complex program, the DOE has planned to submit the application as a draft in two parts. This strategy will allow for the DOE and the EPA to begin technical discussions on critical WIPP issues before the one-year compliance determination period begins. This report is the first of these two draft submittals.

Lessons Learned and Regulatory Countermeasures of Nuclear Safety Issues Last Year

Energy Technology Data Exchange (ETDEWEB)

Lee, Y. E. [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2013-05-15

Competitiveness of nuclear as the electric resource in terms of the least cost and the carbon abatement has been debated. Some institutions insist that the radioactive wastes management cost, nuclear accident cost and cheap shale gas would make the nuclear energy less competitive, while others still address the ability of nuclear energy as economical and low-carbon electric resource. This situation reminds that ensuring nuclear safety is the most important prerequisite to use of nuclear energy. Therefore, this paper will compare the different views on future nuclear competitiveness discussed right after the Fukushima accident and summarize the lessons learned and regulatory countermeasures from nuclear safety issues last year. Korea has improved the effectiveness of safety regulation up to now and still has been making efforts on further enhancing nuclear safety. The outcomes of these efforts have resulted in a high level of safety in Korean NPPs and contributing largely to the global nuclear safety through sharing and exchanging the information and knowledge of our nuclear experiences. However, now we are faced with the new challenges such as decreasing the public. Additionally, public criticism of the regulatory activities demands more clear regulatory guides and transparent process. Recently, new president announced the 'Priority to Safety and Public Trust' as the precondition to utilize the nuclear energy. We will continue to make much more efforts for the improvement of the quality of regulatory activities and effectiveness of regulatory decision making process than we have done so far. Competence through effective capacity building would be a helpful pathway to build up the public trust and ensure the acceptable level of nuclear safety. We are set to prepare the action items to be taken in the near future for improving the technical competency and transparency as the essential components of the national safety and will make efforts to implement them

Explaining G20 and BRICS Compliance

Directory of Open Access Journals (Sweden)

Marina Larionova

2016-11-01

Full Text Available This article explores the internal and external factors influencing the compliance performance of the Group of 20 (G20 and the BRICS. The authors start with an overview of the G20 and BRICS compliance patterns using comparative data onthe number of commitments made by the two institutions, the level of institutional compliance, and distribution of commitments and compliance across issue areas. G20 compliance is traced since the leaders’ first 2008 summit in Washington. The BRICS compliance performance record includes data since the third stand alone summit in Sanya in 2011.The study then takes stock of compliance catalysts embedded in the summits’ discourse: priority placements, numerical targets, timelines, self-accountability pledges and mandates to implement and/or monitor implementation. The authors review trends in the use of catalysts in different years and issue areas and identify commonalities and differences.The analysis then turns to external causes of compliance and focuses on demand for collective actions and members’ collective power to respond and deliver on their pledges. Here the study explores whether the self-accountability mechanisms created by the institutions in response to the demand for effectiveness and legitimacy facilitate compliance.The article concludes by highlighting catalysts, causes of compliance and their combinations with the greatest power to encourage implementation, explaining trends in G20 and BRICS compliance performance. The data sets on G20 and BRICS differ in terms of scale. The G20 data set contains 1,511 commitments of which 114 have been monitored, and the BRICS data set contains 231 commitments of which 23 have been monitored.

Report on the oil and gas construction compliance audit 2005

Energy Technology Data Exchange (ETDEWEB)

NONE

2005-07-01

An increase in oil and gas activity in British Columbia (BC) has prompted concerns about whether the oil and gas industry has maintained compliance with relevant legislation. Following discussions between various government agencies in 2003, a decision was made to conduct annual inter-agency construction compliance audits. The audits lasted approximately 14 days for each phase. During the 2005 audit, teams conducted 135 compliance audit inspections, concentrating on stream crossings, working in and about streams, snow and ice fills and ice bridges; sewage management and disposal at campsites and drilling rigs; special wastes and water usage by camps, drilling rigs and seismic crews. Although most operations were found to be in compliance with these major components, it was suggested industry should continue to take responsibility and be accountable to monitor their activities to ensure compliance with all applicable approval conditions. This would include requiring contractors, construction and exploration personnel to be trained and aware of all regulatory requirements. Industry should also ensure the water use permits are valid for the volumes of water actually required for construction needs. It was concluded that another audit will be conducted during the 2005/6 drilling season. Camp sewage management, water usage and special waste portions of the audit will be conducted over a 2 week period earlier in the year to coincide with higher activity levels. In addition, enforcement responses to persistent offenders should continue to be elevated. Companies should be both encouraged and assisted in developing innovative and progressive methods of addressing difficult and challenging public health, safety and environmental issues. Regional boundary maps were included, as well as stream classifications. 21 tabs., 3 figs.

Development of guidance on applications of regulatory requirements for low specific activity materials and surface contaminated objects

International Nuclear Information System (INIS)

Pope, R.B.; Easton, E.P.; Shankman, S.F.; Boyle, R.W.

1997-01-01

In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant among the changes were major revisions to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). In preparation for the adoption of these requirements into regulations in the United States, it became apparent that guidance on how to apply these requirements, clarifying technical uncertainties and ensuring proper implementation, would be needed both by the regulators and those regulated. Thus, the US Department of Transportation and the U.S. Nuclear Regulatory Commission, with the assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance for LSA material and SCO transport. The guidance will present examples of acceptable methods for demonstrating compliance with the revised rules. Ideas being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment prior to final issue of the guidance in 1997. (Author)

The regulatory framework in the UK

International Nuclear Information System (INIS)

O'Sullivan, R.

1984-01-01

The subject is covered in sections, headed: basic regulatory requirements covering the transport of radioactive material in the UK; responsibility for safety (competent authority; provision of regulations; implementation of regulations (international and national); design of transport flask; safety case; testing; assessment; approval certificate; compliance assurance; administration); advice and information on the regulatory safety standards. (U.K.)

Safety and regulatory review of dyes commonly used as excipients in pharmaceutical and nutraceutical applications.

Science.gov (United States)

Pérez-Ibarbia, Leire; Majdanski, Tobias; Schubert, Stephanie; Windhab, Norbert; Schubert, Ulrich S

2016-10-10

Color selection is one of the key elements of building a strong brand development and product identity in the pharmaceutical industry, besides to prevent counterfeiting. Moreover, colored pharmaceutical dosage forms may increase patient compliance and therapy enhancement. Although most synthetic dyes are classified as safe, their regulations are stricter than other classes of excipients. Safety concerns have increased during the last years but the efforts to change to natural dyes seem to be not promising. Their instability problems and the development of "non-toxic" dyes is still a challenge. This review focuses specifically on the issues related to dye selection and summarizes the current regulatory status. A deep awareness of toxicological data based on the public domain, making sure the compliance of standards for regulation and safety for successful product development is provided. In addition, synthetic strategies are provided to covalently bind dyes on polymers to possibly overcome toxicity issues. Copyright © 2016 Elsevier B.V. All rights reserved.

The effects of the Brazilian regulatory inspection programme on nuclear medicine facilities

Energy Technology Data Exchange (ETDEWEB)

Alves, C E G R; Azevedo, E M; Mendes, L C G; Franca, W F L; Gutterres, R F; Goncalves, M [Comissao Nacional de Energia Nuclear-CGMI/CNEN, Rua General Severiano 90, 22290-901, Rio de Janeiro (Brazil); De Sa, L V; Da Rosa, L A R [Instituto de Radioprotecao e Dosimetria-IRD/CNEN, Avenida Salvador Allende s/n, 22780-160, Rio de Janeiro (Brazil)], E-mail: telo@xexeu.org

2009-12-01

This paper aims to demonstrate the importance of the regulatory inspections carried out by the Brazilian regulatory body in the area of nuclear medicine. The main aspects observed during the inspections are presented as well as the time evolution of the non-compliances, according to their occurrence by type. We also evaluate factors concerning the working of the nuclear medicine facility responsible for solving the non-compliances. The results suggest a decrease of occurrence of non-compliances with time that can be related to the strictness of the inspections and the awareness of the personnel in the nuclear medicine facilities. An analysis of radiation dose exposure levels for the professionals involved in nuclear medicine was carried out; although dose values are below regulatory dose limits, their occurrence is not decreasing satisfactorily. Results indicate the need for staff training and commitment of the responsible nuclear medicine facility staff to the radiological protection procedures. Our results also emphasise the importance of continuous coercive actions to improve the level of radiological protection in nuclear medicine facilities in compliance with the standards established by the national regulatory authority and international recommendations.

Strategies of bringing drug product marketing applications to meet current regulatory standards.

Science.gov (United States)

Wu, Yan; Freed, Anita; Lavrich, David; Raghavachari, Ramesh; Huynh-Ba, Kim; Shah, Ketan; Alasandro, Mark

2015-08-01

In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.

Applying the Analytic Hierarchy Process to Oil Sands Environmental Compliance Risk Management

Science.gov (United States)

Roux, Izak Johannes, III

Oil companies in Alberta, Canada, invested $32 billion on new oil sands projects in 2013. Despite the size of this investment, there is a demonstrable deficiency in the uniformity and understanding of environmental legislation requirements that manifest into increased project compliance risks. This descriptive study developed 2 prioritized lists of environmental regulatory compliance risks and mitigation strategies and used multi-criteria decision theory for its theoretical framework. Information from compiled lists of environmental compliance risks and mitigation strategies was used to generate a specialized pairwise survey, which was piloted by 5 subject matter experts (SMEs). The survey was validated by a sample of 16 SMEs, after which the Analytic Hierarchy Process (AHP) was used to rank a total of 33 compliance risks and 12 mitigation strategy criteria. A key finding was that the AHP is a suitable tool for ranking of compliance risks and mitigation strategies. Several working hypotheses were also tested regarding how SMEs prioritized 1 compliance risk or mitigation strategy compared to another. The AHP showed that regulatory compliance, company reputation, environmental compliance, and economics ranked the highest and that a multi criteria mitigation strategy for environmental compliance ranked the highest. The study results will inform Alberta oil sands industry leaders about the ranking and utility of specific compliance risks and mitigations strategies, enabling them to focus on actions that will generate legislative and public trust. Oil sands leaders implementing a risk management program using the risks and mitigation strategies identified in this study will contribute to environmental conservation, economic growth, and positive social change.

INDONESIA SHARI'AH COMPLIANCE STOCK RETURN BEHAVIOUR

Directory of Open Access Journals (Sweden)

Helma Malini

2017-04-01

Full Text Available This study aims to measures the behaviour of Indonesia Shari'ah compliance stock return. The measurement of return behaviour toward volatility will proved the capability of Indonesia Shari'ah compliance toward volatility that happened in Indonesia during the period of observation. Investing in Shari'ah compliance is quite different than investing in conventional stock which followed the capital market set of rules and law, Shari'ah compliance follows not only the capital market set of laws and but also the Islamic principles of principles. Most of the previous studies examine issues related to the conventional stocks and market. The present study take one step further by investigating issue related to Shari'ah compliance instrument. In the case of Shari'ah stock price in Indonesia, the dynamics volatility of the stock price can be minimized by taking an integrated screening process to the listed company, as precautions steps toward volatility

Regulatory Monitoring of Fortified Foods: Identifying Barriers and Good Practices

Science.gov (United States)

Rowe, Laura A; Vossenaar, Marieke; Garrett, Greg S

2015-01-01

While fortification of staple foods and condiments has gained enormous global traction, poor performance persists throughout many aspects of implementation, most notably around the critical element of regulatory monitoring, which is essential for ensuring foods meet national fortification standards. Where coverage of fortified foods is high, limited nutritional impact of fortification programs largely exists due to regulatory monitoring that insufficiently identifies and holds producers accountable for underfortified products. Based on quality assurance data from 20 national fortification programs in 12 countries, we estimate that less than half of the samples are adequately fortified against relevant national standards. In this paper, we outline key findings from a literature review, key informant interviews with 11 fortification experts, and semi-quantitative surveys with 39 individuals from regulatory agencies and the food fortification industry in 17 countries on the perceived effectiveness of regulatory monitoring systems and barriers to compliance against national fortification standards. Findings highlight that regulatory agencies and industry disagree on the value that enforcement mechanisms have in ensuring compliance against standards. Perceived political risk of enforcement and poorly resourced inspectorate capacity appear to adversely reinforce each other within an environment of unclear legislation to create a major hurdle for improving overall compliance of fortification programs against national standards. Budget constraints affect the ability of regulatory agencies to create a well-trained inspector cadre and improve the detection and enforcement of non-compliant and underfortified products. Recommendations to improve fortification compliance include improving technical capacity; ensuring sustained leadership, accountability, and funding in both the private and the public sectors; and removing political barriers to ensure consistent detection of

Office of Geologic Respositories issues hierarchy for a Mined Geologic Disposal System (OGR/B-10)

International Nuclear Information System (INIS)

1986-09-01

The Office of Geologic Repositories (OGR) has adopted an issues hierarchy for use by all Project Offices. The issues hierarchy provides a framework for representing issues related to regulatory requirements for siting and licensing a mined geologic disposal system (MGDS) and for describing the work that needs to be completed during site characterization to resolve those issues. The issues in the issues hierarchy are defined as the questions relating to the performance of the MGDS that must be resolved to demonstrate compliance with the applicable federal regulations (including 10 CFR Part 60, 10 CFR Part 960, 40 CFR Part 191, and 10 CFR Part 20). The issues hierarchy is structured around four broad areas of regulatory concern related to the requirements for siting and licensing an MGDS (postclosure performance, preclosure radiological safety, non-radiological environmental impacts, and feasibility and cost of MGDS development), and provides the framework for definition of the information needed to satisfy the applicable regulatory requirements in each of these areas. The purpose of this document is to present the issues hierarchy, describe the rationale used to develop the hierarchy, and describe how the issues hierarchy is used in program planning. Section 2 presents the overall rationale for the issues hierarchy, and explains the structure and organization of the hierarchy. Section 3 presents the issues hierarchy itself and Section 4 describes the basis for the development of individual issues. Section 5 provides a correlation between the issues and the applicable federal regulations being addressed. Section 6 describes how the issues drive development of plans in support of siting and licensing requirements through use of an issue resolution strategy that includes performance allocation

Regulatory analysis for the resolution of generic issue C---8, main steam isolation valve leakage and LCS [leakage control system] failure

International Nuclear Information System (INIS)

Graves, C.C.

1990-06-01

Generic Issue C-8 deals with staff concerns about public risk because of the incidence of leak test failures reported for main steam isolation valves (MSIVs) at boiling water reactors and the limitations of the leakage control systems (LCSs) for mitigating the consequences of leakage from these valves. If the MSIV leakage is greatly in excess of the allowable value in the technical specifications, the LCS would be unavailable because of design limitations. The issue was initiated in 1983 to assess (1) the causes of MSIV leakage failures, (2) the effectiveness of the LCS and alternative mitigation paths, and (3) the need for additional regulatory action to reduce public risk. This report presents the regulatory analysis for Generic Issue C-8 and concludes that no new regulatory requirements are warranted

The Canadian Natural Health Products (NHP regulations: industry perceptions and compliance factors

Directory of Open Access Journals (Sweden)

Boon Heather

2006-05-01

Full Text Available Abstract Background The use of natural health products, such as vitamins, minerals, and herbs, by Canadians has been increasing with time. As a result of consumer concern about the quality of these products, the Canadian Department of Health created the Natural Health Products (NHP Regulations. The new Canadian regulations raise questions about whether and how the NHP industry will be able to comply and what impact they will have on market structure. The objectives of this study were to explore who in the interview sample is complying with Canada's new NHP Regulations (i.e., submitted product licensing applications on time; and explore the factors that affect regulatory compliance. Methods Twenty key informant interviews were conducted with employees of the NHP industry. The structured interviews focused on the level of satisfaction with the Regulations and perceptions of compliance and non-compliance. Interviews were tape recorded and then transcribed verbatim. Data were independently coded, using qualitative content analysis. Team meetings were held after every three to four interviews to discuss emerging themes. Results The major finding of this study is that most (17 out of 20 companies interviewed were beginning to comply with the new regulatory regime. The factors that contribute to likelihood of regulatory compliance were: perceptions and knowledge of the regulations and business size. Conclusion The Canadian case can be instructive for other countries seeking to implement regulatory standards for natural health products. An unintended consequence of the Canadian NHP regulations may be the exit of smaller firms, leading to industry consolidation.

A compliance testing program for diagnostic X-ray equipment

International Nuclear Information System (INIS)

Hutchinson, D.E.; Cobb, B.J.; Jacob, C.S.

1999-01-01

Compliance testing is nominally that part of a quality assurance program dealing with those aspects of X-ray equipment performance that are subject to radiation control legislation. Quality assurance programs for medical X-ray equipment should be an integral part of the quality culture in health care. However while major hospitals and individual medical centers may implement such programs with some diligence, much X-ray equipment can remain unappraised unless there is a comprehensive regulatory inspection program or some form of compulsion on the equipment owner to implement a testing program. Since the late 1950s all X-ray equipment in the State of Western Australia has been inspected by authorized officers acting on behalf of the Radiological Council, the regulatory authority responsible for administration of the State's Radiation Safety Act. However, economic constraints, coupled with increasing X-ray equipment numbers and a geographically large State have significantly affected the inspection rate. Data available from inspections demonstrate that regular compliance and performance checks are essential in order to ensure proper performance and to minimize unnecessary patient and operator dose. To ensure that diagnostic X-ray equipment complies with accepted standards and performance criteria, the regulatory authority introduced a compulsory compliance testing program for all medical, dental and chiropractic diagnostic X-ray equipment effective from 1 January 1997

Compliance with Environmental Regulations through Complex Geo-Event Processing

OpenAIRE

Federico Herrera; Laura González; Daniel Calegari; Bruno Rienzi

2017-01-01

In a context of e-government, there are usually regulatory compliance requirements that support systems must monitor, control and enforce. These requirements may come from environmental laws and regulations that aim to protect the natural environment and mitigate the effects of pollution on human health and ecosystems. Monitoring compliance with these requirements involves processing a large volume of data from different sources, which is a major challenge. This volume is also increased with ...

Development of regulatory technologies of key issues of radiation sources in the medical and industrial fields

International Nuclear Information System (INIS)

Lee, Jae Seong; Kim, Byung Soo; Ku, Bon Chul

2006-08-01

The aim of this research is to provide with rational bases to address the key issues raising up during the expansion of RI/RG usage in the medical and industrial fields, thus eventually contribute to enhancing the effectiveness of national regulatory systems. Related key issues that are introduced in the medical and industrial fields are analyzed and some outcomes are produced. The following results are attained. - Estimation Methodology Development of Regulatory Effects for the Use of Radioactive Substances, - Survey on Domestic Status of Nuclear Materials and Review on Domestic/Foreign Regulatory System for Nuclear Materials Regulation, - Comparative Analysis of KSTAR and Fusion Facilities of Advanced Countries, - Radiological Characteristics of Proton Therapy and Analysis of Foreign Cases and Systems, - Detection and Safety Analysis of Leak Radiation of High Energy Medical Generators, - Survey and Analysis on Usage and Requirements of Sealed Sources, - Incidents/Accidents Reporting System for RI-related Facilities, - Development of Audio-Visual Education Materials for Radiation Workers, - Development of Major Safety Procedures for Portable RIs, - Expansion of Existing DB for Radiation Devices including New Domestic Ones, - Survey of Foreign Status of Quality Maintenance System for Radiation equipment

Overview of Fukushima accident and regulatory issues for FCFS after the accident

International Nuclear Information System (INIS)

Ueda, Y.

2013-01-01

In the first part of his presentation Yoshinori Ueda (JNES, Japan) gave an overview of the Fukushima accident and an outline of the emergency safety measures and response at the NPP site. The second part was focused on the regulatory issues for FCFs after the accident. The first issue was the emergency safety measures in case of total loss of AC power (loss capabilities of decay heat removal and hydrogen accumulation prevention) and tsunami in the reprocessing facilities and associated spent fuel storages at Tokai and Rokkasho plants. The second issue was the directions to the licensees of these facilities to secure the work environment in the main control rooms in case of complete loss of AC power, to secure communication within the facility in case of such emergency, and to secure material and equipment for radiation protection, and to deploy heavy tools for rubble removal. No paper has been made available for this presentation

"Smart pharmacy" master blends integrated supply chains with patient care to uphold regulatory compliances.

Science.gov (United States)

Bhinder, Prabhjot; Oberoi, Mandeep Singh

2009-01-01

Hospitals require better information connectivity because timing and content of the information to be traded is critical. The imperative success in the past has generated renewed thrust on the expectations and credibility of the current enterprise resource planning (ERP) applications in health care. The desire to bring improved connectivity and to match it with critical timing remains the penultimate dream. Currently, majority of ERP system integrators are not able to match these requirements of the healthcare industry. It is perceived that the concept of ERP has made the process of segregating bills and patient records much easier. Hence the industry is able to save more lives, but at the cost of an individual's privacy as it enables to access the database of patients and medical histories through the common database shared by hospitals though at a quicker rate. Businesses such as health care providers, pharmaceutical manufacturers, and distributors have already implemented rapid ERPs. The new concept "Smart Pharmacies" will link the process all the way from drug delivery, patient care, demand management, drug repository, and pharmaceutical manufacturers while maintaining Regulatory Compliances and make the vital connections where these Businesses will talk to each other electronically.

Alberta Energy and Utilities Board, regulatory highlights for 1998

International Nuclear Information System (INIS)

1999-01-01

This new publication informs readers about what the Alberta Energy and Utilities Board (EUB) did in the past year, including important regulatory issues, trends and initiatives. The EUB is an agency of the provincial government, established to regulate Alberta's energy resource and utility sectors. It is part of the Alberta Ministry of Energy. The four main functions of the Board are regulatory initiatives, license applications, enforcement and information. This publication summarized the EUB's position regarding flaring (both solution gas flaring and well test flaring), and Board activities in the areas of animal health concerns, the gas over bitumen controversy, the deregulation of the electric industry and what it means to the EUB, improvements in data quality as a result of improved industry compliance in reporting, and a variety of issues related to the oil sands and the negotiated settlement process. Also, the Board has been proactive in the area of oilfield waste management guidelines, proliferation policies for gas processing facilities, sulphur recovery guidelines, and the expansion of the orphan well program to include facilities and pipelines. As a measure of the success of the EUB, a recent survey of 19 randomly selected focus groups praised EUB for its impartiality, fair and equitable enforcement and independence. It was also praised for its technically competent and experienced staff, its access to quality information and the clarity of its mandate, regulatory requirements and processes. The Board's efforts in the area of timely stakeholder consultation was highlighted. tabs., figs

Formerly Utilized Sites Remedial Action Program environmental compliance assessment checklists

Energy Technology Data Exchange (ETDEWEB)

Levine, M.B.; Sigmon, C.F.

1989-09-29

The purpose of the Environmental Compliance Assessment Program is to assess the compliance of Formerly Utilized Site Remedial Action Program (FUSRAP) sites with applicable environmental regulations and Department of Energy (DOE) Orders. The mission is to identify, assess, and decontaminate sites utilized during the 1940s, 1950s, and 1960s to process and store uranium and thorium ores in support of the Manhattan Engineer District and the Atomic Energy Commission. To conduct the FUSRAP environmental compliance assessment, checklists were developed that outline audit procedures to determine the compliance status of the site. The checklists are divided in four groups to correspond to these regulatory areas: Hazardous Waste Management, PCB Management, Air Emissions, and Water Discharges.

Formerly Utilized Sites Remedial Action Program environmental compliance assessment checklists

International Nuclear Information System (INIS)

Levine, M.B.; Sigmon, C.F.

1989-01-01

The purpose of the Environmental Compliance Assessment Program is to assess the compliance of Formerly Utilized Site Remedial Action Program (FUSRAP) sites with applicable environmental regulations and Department of Energy (DOE) Orders. The mission is to identify, assess, and decontaminate sites utilized during the 1940s, 1950s, and 1960s to process and store uranium and thorium ores in support of the Manhattan Engineer District and the Atomic Energy Commission. To conduct the FUSRAP environmental compliance assessment, checklists were developed that outline audit procedures to determine the compliance status of the site. The checklists are divided in four groups to correspond to these regulatory areas: Hazardous Waste Management, PCB Management, Air Emissions, and Water Discharges

Scalable human ES culture for therapeutic use: propagation, differentiation, genetic modification and regulatory issues.

Science.gov (United States)

Rao, M

2008-01-01

Embryonic stem cells unlike most adult stem cell populations can replicate indefinitely while preserving genetic, epigenetic, mitochondrial and functional profiles. ESCs are therefore an excellent candidate cell type for providing a bank of cells for allogenic therapy and for introducing targeted genetic modifications for therapeutic intervention. This ability of prolonged self-renewal of stem cells and the unique advantages that this offers for gene therapy, discovery efforts, cell replacement, personalized medicine and other more direct applications requires the resolution of several important manufacturing, gene targeting and regulatory issues. In this review, we assess some of the advance made in developing scalable culture systems, improvement in vector design and gene insertion technology and the changing regulatory landscape.

Inorganic chemical quality of European tap-water: 1. Distribution of parameters and regulatory compliance

International Nuclear Information System (INIS)

Banks, David; Birke, Manfred; Flem, Belinda; Reimann, Clemens

2015-01-01

Highlights: • A pan-European survey comprises >60 inorganic parameters in 579 tap water samples. • Compliance with standards for inorganic parameters is good (>99% in EU states). • Around 1% non-compliance is observed for arsenic and 0.2% for uranium. • No sample of water contained nitrate in excess of 45 mg/L. • A weak co-variation in Cu and Pb could indicate derivation from plumbing. - Abstract: 579 tap water samples were collected at the European scale and analysed in a single laboratory for more than 60 parameters. This dataset is evaluated here in terms of the statistical distribution of the analysed parameters and compliance with EU and international drinking water regulations. For most parameters a 99% (or better) degree of compliance was achieved. Among the parameters with the higher rates of non-compliance are: arsenic (1% non-compliance in EU member states, 1.6% when samples from non-EU states are also considered) and sodium (0.6%/1.0%). The decision by the WHO to raise its provisional guideline from 15 μg/L (WHO, 2004) to 30 μg/L (WHO, 2011) has reduced non-compliance for uranium from 1.0% to 0.2%. Despite the fact that tap water (i.e. presumed treated water) was collected, many observations can still be interpreted in terms of hydrogeochemical processes. The dataset demonstrates the potential value of very cost-effective, low-density sampling approaches at a continental (European) scale

340 Facility compliance assessment

International Nuclear Information System (INIS)

English, S.L.

1993-10-01

This study provides an environmental compliance evaluation of the RLWS and the RPS systems of the 340 Facility. The emphasis of the evaluation centers on compliance with WAC requirements for hazardous and mixed waste facilities, federal regulations, and Westinghouse Hanford Company (WHC) requirements pertinent to the operation of the 340 Facility. The 340 Facility is not covered under either an interim status Part A permit or a RCRA Part B permit. The detailed discussion of compliance deficiencies are summarized in Section 2.0. This includes items of significance that require action to ensure facility compliance with WAC, federal regulations, and WHC requirements. Outstanding issues exist for radioactive airborne effluent sampling and monitoring, radioactive liquid effluent sampling and monitoring, non-radioactive liquid effluent sampling and monitoring, less than 90 day waste storage tanks, and requirements for a permitted facility

Safety Committees for Argentinean Research Reactor - Regulatory Issues

International Nuclear Information System (INIS)

Perrin, Carlos D.

2009-01-01

In the field of radiological and nuclear safety, the Nuclear Regulatory Authority (ARN) of Argentina controls three research reactors and three critical assemblies, by means of evaluations, audits and inspections, in order to ensure the fulfillment of the requirements established in the Licenses, in the Regulatory Standards and in the Mandatory Documentation in general. From the Nuclear Regulatory Authority's point of view, within the general process of research reactors safety management, the Operational Organization self verification of radiological and nuclear safety plays an outstanding role. In this aspect the ARN has established specific requirements in the Regulatory Standards, in the Operation Licenses and in the Operational Limits and Conditions. These requirements include the figure of different safety committees, which act as reviewers or advisers in diverse situations. This paper describes the main characteristics of the committees, their function, scope and the regulatory documents where the requirements are included. (author)

The site-characterization plan and its role in resolving siting and licensing issues

International Nuclear Information System (INIS)

Hanlon, C.L.

1986-01-01

As required by the Nuclear Waste Policy Act and the Nuclear Regulatory Commission (NRC) in 10 CFR Part 60, the Department of Energy is preparing plans for conducting site characterization at three candidate sites. Prepared according to a detailed annotated outline that is based on the NRC's Regulatory Guide 4.17, these plans will present the information collected to date about the geologic, hydrologic, geochemical, geoengineering, and climatic conditions of each site; describe the design of the repository and the waste package; and discuss the site-characterization program. The most important portions of the plan will be the strategy for resolving siting and licensing issues and the description of the testing and analysis program to be followed in resolving these issues. The issues-resolution strategy consists of identifying issues and the associated information needs; allocating performance goals for various components of the repository system; developing a testing plan to gather the necessary information; gathering and analyzing the information; and documenting the results for use in site selection and licensing. The issues-resolution strategy will allow the Department to define all of the issues that must be resolved in order to demonstrate compliance with applicable regulations and to specify the information needed to resolve these issues. It will provide a consistent framework and establish priorities for the Department's site-characterization effort for the next several years

Elements to evaluate the intention in the non-compliance s or violations to the regulatory framework in the national nuclear facilities; Elementos para evaluar la intencionalidad en los incumplimientos o violaciones al marco regulador en las instalaciones nucleares nacionales

Energy Technology Data Exchange (ETDEWEB)

Espinosa V, J. M.; Gonzalez V, J. A., E-mail: jmespinosa@cnsns.gob.mx [Comision Nacional de Seguridad Nuclear y Salvaguardias, Dr. Jose Ma. Barragan No. 779, Col. Narvarte, 03020 Mexico D. F. (Mexico)

2013-10-15

Inside the impact evaluation process to the safety of non-compliance s or violations, developed and implanted by the Comision Nacional de Seguridad Nuclear y Salvaguardias (CNSNS), the Guide for the Impact Evaluation to the Safety in the National Nuclear Facilities by Non-compliance s or Violations to the Regulatory Framework was developed, which indicates that in the determination of the severity (graveness level) of a non-compliance or violation, four factors are evaluated: real and potential consequences to the safety, the impact to the regulator process and the intention. The non-compliance s or intentional violations are of particular interest, since the development of the regulatory activities of the CNSNS considers that the personnel of the licensees, as well as their contractors, will act and will communicate with integrity and honesty. The CNSNS cannot tolerate intentional non-compliance s, for what this violations type can be considered of a level of more graveness that the subjacent non-compliance. To determine the severity of a violation that involves intention, the CNSNS also took in consideration factors as the position and the personnel's responsibilities involved in the violation, the graveness level of the non-compliance in itself, the offender's intention and the possible gain that would produce the non-compliance, if exists, either economic or of another nature. The CNSNS hopes the licensees take significant corrective actions in response to non-compliance s or intentional violations, these corrective actions should correspond to the violation graveness with the purpose of generating a dissuasive effect in the organizations of the licensees. The present article involves the legal framework that confers the CNSNS the attributions to impose administrative sanctions to its licensees, establishes the definition of the CNSNS about what constitutes a non-compliance or intentional violation and finally indicates the intention types (deliberate

Acid rain compliance: Coordination of state and federal regulation

International Nuclear Information System (INIS)

Nordhaus, R.R.

1992-01-01

The Clean Air Act (CAA) Amendments of 1990 impose new controls on emissions by electric utilities of the two major precursors of acid rain: sulfur dioxide (SO2) and oxides of nitrogen (NOx). Utilities, and the utility holding company systems and power pools of which they are members, will be subject to extensive and costly compliance obligations under the new statute. Most of these utilities, utility systems, and power pools are regulated by more than one utility regulatory authority. Some utilities are regulated by several states, some by a single state and by the Federal Energy Regulatory Commission (FERC), and some by multiple states, by the FERC, and by the Securities and Exchange Commission (SEC). Utility regulators will need to coordinate their policies for ratemaking and for reviewing acid rain compliance strategies if least cost solutions are to be implemented without imposing on ratepayers and utility shareholders the costs and risks of inconsistent regulatory determinations. This article outlines the scope of the coordination problem and addresses possible approaches that utility regulators may take to deal with this problem

Varying the Quality of Business Communication Caused by Compliance of Different Accounting Rules

Directory of Open Access Journals (Sweden)

Agus Setyadi

2009-06-01

Full Text Available This study examines the extent of Indonesian companies‟ compliance with the Indonesian accounting regulations (IARC of inventory, fixed assets, and depreciation by analyzing 160 Indonesian listed companies‟ 2006 annual reports. This study also looks at potential factors that explain the level of this compliance. Analysis reveals a high level of 71.63% inventory compliance, 51.13% fixed assets compliance, and 99.69% depreciation compliance with accounting rules. T-test and regression analysis show that firm size is a significant predictor of accounting compliance. Importantly, ownership and governance structures do not influence the level of compliance. Although Indonesian firms complied with more than 50% of the key accounting rule provisions, regulatory intervention appears needed to improve compliance. Such regulation might include sanctions as promulgated by multilateral financial organizations (World Bank 2005.

Environmental compliance audits of electric generating facilities - a practical approach

International Nuclear Information System (INIS)

Staker, R.D.

1992-01-01

As environmental regulations expand in complexity and number, and as regulatory agencies place more emphasis on enforcing regulations, it is increasingly important that electric utilities perform periodic environmental compliance audits to determine if their facilities are in compliance with federal, state, and local environmental regulations. Explicit commitment by the utility's top management and careful planning and execution of an audit are key elements in the effectiveness of an audit. This paper is directed to electric utility environmental managers and company management. The paper presents a practical approach for planning and performing a multi-media environmental compliance of an electric generating facility

Inter-generational Decision Making for Radioactive Waste Disposal, Policy and Science: Regulatory Protection Forever?

International Nuclear Information System (INIS)

Regnier, E.P.; Wallo, A.

2006-01-01

Assumptions about this generation's duty to future generations underlie decisions on regulatory requirements for disposal of radioactive waste. Regulatory provisions related to time of compliance, dose criteria, and institutional controls, for example, continue to be topics of discussion as regulations are revised or compared. Subjective and difficult ethical issues are either explicit or implicit in these discussions. The information and criteria used must be relevant and help make good decisions that, ideally, increase the overall welfare of future generations. To what extent can or should science usefully inform such decision-making? Both the National Academies of Science and the National Academy of Public Administration (NAPA) have reported on this topic, albeit from different viewpoints. This paper explains and expands upon the rationale used for setting compliance time periods such as the Department of Energy's requirement for a 1,000 year time of compliance with dose limits for low-level radioactive waste disposal facilities. It evaluates radioactive waste disposal against principles of equity recommended by NAPA. Radioactive waste disposal standards require evaluation of impacts much farther into the future than has been common for other endeavors with very long term effects. While performance assessment analyses provide much useful information, their inherent uncertainties over long time periods preclude the projection of reality. Thus, the usefulness of extremely long projections in supporting good decisions that promote the welfare of future generations is limited. Such decisions are fundamentally a question of resource allocation, equity, and fairness. (authors)

Interaction of Compliance and Voluntary Renewable Energy Markets

Energy Technology Data Exchange (ETDEWEB)

Bird, L.; Lokey, E.

2007-10-01

In recent years, both compliance and voluntary markets have emerged to help support the development of renewable energy resources. Both of these markets are growing rapidly and today about half of U.S. states have RPS policies in place, with a number of these policies adopted in the last several years. In addition, many states have recently increased the stringency of their RPS policies. This paper examines key market interaction issues between compliance and voluntary renewable energy markets. It provides an overview of both the compliance and voluntary markets, addressing each market's history, purpose, size, scope, and benefits while addressing issues, including double counting.

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 3 - LBA and immunogenicity).

Science.gov (United States)

Stevenson, Lauren; Amaravadi, Lakshmi; Myler, Heather; Salazar-Fontana, Laura; Gorovits, Boris; Kirshner, Susan; Xue, Li; Garofolo, Fabio; Alley, Stephen C; Thway, Theingi; Joyce, Alison; Bansal, Surendra; Beaver, Chris; Bergeron, Annik; Cai, Xiao-Yan; Cojocaru, Laura; DeSilva, Binodh; Dumont, Isabelle; Fluhler, Eric; Fraser, Stephanie; Gouty, Dominique; Gupta, Swati; Haidar, Sam; Hayes, Roger; Ingelse, Benno; Ishii-Watabe, Akiko; Kaur, Surinder; King, Lindsay; Laterza, Omar; Leung, Sheldon; Lévesque, Ann; Ma, Mark; Petit-Frere, Corinne; Pillutla, Renuka; Rose, Mark; Schultz, Gary; Smeraglia, John; Swanson, Steven; Torri, Albert; Vazvaei, Faye; Wakelin-Smith, Jason; Wilson, Amanda; Woolf, Eric; Yang, Tong-Yuan

2014-01-01

The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion in the evolving field of bioanalysis, took place in Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations and regulatory agencies worldwide convened to share, review, discuss and agree on approaches to address current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches and immunogenicity. From the prolific discussions held during the workshop, specific recommendations are presented in this 2014 White Paper. As with the previous years' editions, this paper acts as a practical tool to help the bioanalytical community continue advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2014 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations for Large molecules bioanalysis using LBA and Immunogenicity. Part 1 (Small molecules bioanalysis using LCMS) and Part 2 (Hybrid LBA/LCMS, Electronic Laboratory Notebook and Regulatory Agencies' Input) were published in the Bioanalysis issues 6(22) and 6(23), respectively.

Compliance demonstration: What can be reasonably expected from safety assessment for geological repositories?

International Nuclear Information System (INIS)

Zuidema, P.; Smith, P.; Sumerling, T.

1999-01-01

When licensing a nuclear facility, it is important to demonstrate that it will comply with regulatory limits (e.g. individual dose limits) and also show that sufficient attention has been paid to optimisation of facility design and operation, such that any associated radiological impacts will be as low as reasonably achievable (ALARA). In general, in demonstrating compliance, experience can be drawn from the performance of existing and similar facilities, and monitoring plans can be specified that will confirm that actual radiological discharges during operations are within authorised limits for the facility. This is also true in respect of the operational period of a geological repository. For the post-closure phase of a repository, however, it is also necessary to show that possible releases will remain acceptably low even at long times in the future when, it is assumed, control of the facility has lapsed and there is no method of either monitoring releases or taking remedial action in the case of unexpected events or releases. In addition, within each country, a deep geological repository will be a first-of-a-kind development so that compliance arguments can be expected to be rigorously tested without any assistance from the precedent of licensing of similar facilities nationally. This puts heavy, and quite unusual, burdens on the long-term safety assessment for a geological repository to develop a case that is sufficiently strong to demonstrate compliance. This paper focuses on the problem of demonstrating compliance with long-term safety requirements for a geological repository, and explores: the overall aims and special difficulties of demonstrating compliance for a geological repository; the role of safety assessment in demonstrating compliance; the scope for optimisation of a geological repository and importance of robustness and lessons learnt from the application of safety assessment. In addition, some issues requiring further discussion and clarification

Development of guidance on applications of regulatory requirements for low specific activity materials and surface contaminated objects

International Nuclear Information System (INIS)

Pope, R.B.; Easton, E.P.; Shankman, S.F.

1997-01-01

In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant among the changes were major revisions to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). In preparation for the adoption of these requirements into regulations in the United States, it became apparent that guidance on how to apply these requirements, clarifying technical uncertainties and ensuring proper implementation, would be needed both by the regulators and those regulated. Thus, the US Department of Transportation and the US Nuclear Regulatory Commission, with the assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance for LSA material and SCO transport. The guidance will present examples of acceptable methods for demonstrating compliance with the revised rules. Ideas being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment prior to final issuance of the guidance in 1997

Regulatory analysis for the resolution of Unresolved Safety Issue A-44, Station Blackout. Draft report

International Nuclear Information System (INIS)

Rubin, A.M.

1986-01-01

''Station Blackout'' is the complete loss of alternating current (ac) electric power to the essential and nonessential buses in a nuclear power plant; it results when both offsite power and the onsite emergency ac power systems are unavailable. Because many safety systems required for reactor core decay heat removal and containment heat removal depend on ac power, the consequences of a station blackout could be severe. Because of the concern about the frequency of loss of offsite power, the number of failures of emergency diesel generators, and the potentially severe consequences of a loss of all ac power, ''Station Blackout'' was designated as Unresolved Safety Issue (USI) A-44. This report presents the regulatory analysis for USI A-44. It includes: (1) a summary of the issue, (2) the proposed technical resolution, (3) alternative resolutions considered by the Nuclear Regulatory Commission (NRC) staff, (4) an assessment of the benefits and costs of the recommended resolution, (5) the decision rationale, and (6) the relationship between USI A-44 and other NRC programs and requirements

Recent Findings on Tax-Related Regulatory Burden on SMMEs in South Africa. Literature Review and Policy Options

OpenAIRE

Doubell Chamberlain; Anja Smith

2006-01-01

Regulatory compliance costs impose a deadweight burden on firms and therefore should be minimised. In achieving this goal, it is necessary to embrace a process of smart regulation, rather than focus on deregulation. Tax compliance cost is one type of regulatory costs that is often viewed to have a large negative impact on SMMEs. To gauge the impact of this cost on small business in South Africa, this document reviews three available studies on the impact of tax compliance costs on South Afric...

A single-laboratory validated method for the generation of DNA barcodes for the identification of fish for regulatory compliance.

Science.gov (United States)

Handy, Sara M; Deeds, Jonathan R; Ivanova, Natalia V; Hebert, Paul D N; Hanner, Robert H; Ormos, Andrea; Weigt, Lee A; Moore, Michelle M; Yancy, Haile F

2011-01-01

The U.S. Food and Drug Administration is responsible for ensuring that the nation's food supply is safe and accurately labeled. This task is particularly challenging in the case of seafood where a large variety of species are marketed, most of this commodity is imported, and processed product is difficult to identify using traditional morphological methods. Reliable species identification is critical for both foodborne illness investigations and for prevention of deceptive practices, such as those where species are intentionally mislabeled to circumvent import restrictions or for resale as species of higher value. New methods that allow accurate and rapid species identifications are needed, but any new methods to be used for regulatory compliance must be both standardized and adequately validated. "DNA barcoding" is a process by which species discriminations are achieved through the use of short, standardized gene fragments. For animals, a fragment (655 base pairs starting near the 5' end) of the cytochrome c oxidase subunit 1 mitochondrial gene has been shown to provide reliable species level discrimination in most cases. We provide here a protocol with single-laboratory validation for the generation of DNA barcodes suitable for the identification of seafood products, specifically fish, in a manner that is suitable for FDA regulatory use.

Development of safety-related regulatory requirements for nuclear power in developing countries. Key issue paper no. 4

International Nuclear Information System (INIS)

Han, K.I.

2000-01-01

In implementing a national nuclear power program, balanced regulatory requirements are necessary to ensure nuclear safety and cost competitive nuclear power, and to help gain public acceptance. However, this is difficult due to the technology-intensive nature of the nuclear regulatory requirements, the need to reflect evolving technology and the need for cooperation among multidisciplinary technical groups. This paper suggests approaches to development of balanced nuclear regulatory requirements in developing countries related to nuclear power plant safety, radiation protection and radioactive waste management along with key technical regulatory issues. It does not deal with economic or market regulation of electric utilities using nuclear power. It suggests that national regulatory requirements be developed using IAEA safety recommendations as guidelines and safety requirements of the supplier country as a main reference after careful planning, manpower buildup and thorough study of international and supplier country's regulations. Regulation making is not recommended before experienced manpower has been accumulated. With an option that the supplier country's regulations may be used in the interim, the lack of complete national regulatory requirements should not deter introduction of nuclear power in developing countries. (author)

Emission trading schemes: potential revenue effects, compliance costs and overall tax policy issues

International Nuclear Information System (INIS)

Pope, Jeff; Owen, Anthony D.

2009-01-01

The case for the imposition of carbon (emission) taxes or tradable carbon permits in important tax jurisdictions is arguably strong, based upon the polluter pays principle first proposed by Pigou almost a century ago. This paper briefly reviews the arguments for and against these market-based instruments, and discusses their relative advantages and disadvantages in a practical context. In the case of Australia, the revenue effect of the proposed tradable carbon permits scheme is estimated to be A$11.5 billion in 2010-11. For comparison, this is roughly equivalent to a quarter of the revenue from the Goods and Services Tax. The paper focuses on three neglected aspects of climate change taxation discussion to date: how much tax revenue is likely to be raised, and the administrative and compliance costs of an emissions trading scheme, with particular reference to Australia. In discussing these issues, the paper draws upon selected and relevant international experience, particularly the European Union emissions trading scheme. The challenges of an emissions trading scheme, including integration with the existing tax system, particularly in an Australian context, are also discussed. The paper concludes by emphasising the key challenges and issues facing this 'ultimate externality' debate, particularly from a taxation policy perspective.

Regulatory review of NPP Krsko Periodic Safety Review

International Nuclear Information System (INIS)

Lovincic, D.; Muehleisen, A.; Persic, A.

2004-01-01

At the request of the Slovenian Nuclear Safety Administration (SNSA), Krsko NPP prepared a Periodic Safety Review (PSR) program in January 2001. This is the first PSR of NPP Krsko, the only nuclear power plant in Slovenia. The program was reviewed by the IAEA mission in May 2001 and approved by SNSA in July 2001. The program is made in accordance with the IAEA Safety Guide 'Periodic Safety Review of Operational Nuclear Power Plants' No. 50-SG-012 and with European practice. It contains a systematic review of operation of the NPP Krsko, including the review of the changes as a result of the modernization of the facility. The main tasks of PSR are review of plant status for each safety factor, development of aging and life cycle management program, review of seismic design and PSHA analysis and update of regulatory compliance program. The prioritization process of findings and action plan are also important tasks of PSR. The basic safety factors of the PSR review are: Operational Experience, Safety Assessment and Analyses, Equipment Qualification and Ageing Management, Safety Culture, Emergency Planing, Environmental Impact and Radioactive Waste, Compliance with license requirements and Prioritization. It had been agreed that SNSA will have reviewed all PSR reports generated during the PSR process. At the end of 2003 the PSR Summary Report with selected recommendations for action plan was completed and delivered to SNSA for review. The paper presents regulatory review of NPP Krsko PSR with emphasis on the evaluation of the PSR issues ranking process. (author)

2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 1--small molecules by LCMS).

Science.gov (United States)

Fluhler, Eric; Hayes, Roger; Garofolo, Fabio; Dumont, Isabelle; Blaye, Olivier Le; Arnold, Mark; Bansal, Surendra; Verhaeghe, Tom; Wilson, Amanda; Stevenson, Lauren; Myler, Heather; Bauer, Ronald; Bergeron, Annik; Bustard, Mark; Cai, Xiao-Yan; Carbone, Mary; Cojocaru, Laura; Desai-Krieger, Daksha; Duggan, Jeff; Haidar, Sam; Ho, Stacy; Ingelse, Benno; Katori, Noriko; Lévesque, Ann; Lowes, Steve; Ma, Mark; Mettke, Katalina; Michon, Josée; Musuku, Adrien; Olah, Timothy; Patel, Shefali; Rose, Mark; Schultz, Gary; Smeraglia, John; Spooner, Neil; Stouffer, Bruce; Vazvaei, Faye; Wakelin-Smith, Jason; Wang, Jian; Welink, Jan; Whale, Emma; Woolf, Eric; Xue, Li; Yang, Tong-Yuan

2014-01-01

The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion in the evolving field of bioanalysis, took place in Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations and regulatory agencies worldwide convened to share, review, discuss and agree on approaches to address current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches and immunogenicity. From the prolific discussions held during the workshop, specific recommendations are presented in this 2014 White Paper. As with the previous years' editions, this paper acts as a practical tool to help the bioanalytical community continue advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2014 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 1) covers the recommendations for small molecule bioanalysis using LCMS. Part 2 (Hybrid LBA/LCMS, Electronic Laboratory Notebook and Regulatory Agencies' input) and Part 3 (Large molecules bioanalysis using LBA and Immunogenicity) will be published in the upcoming issues of Bioanalysis.

Building regulations in energy efficiency: Compliance in England and Wales

International Nuclear Information System (INIS)

Pan Wei; Garmston, Helen

2012-01-01

There is an international pragmatic shift towards the use of building energy regulations, standards and codes to reduce building energy consumption. The UK Government revised Building Regulations in 2002, 2006 and 2010, towards more stringent energy efficiency standards and ultimately the target of ‘zero carbon’ new homes from 2016. This paper aims to: reveal levels of compliance with energy Building Regulations of new-build dwellings in England and Wales; explore underlying issues; and identify possible solutions. In total 376 new-build dwellings were investigated. The compliance revealed was poor, at a level of 35%; accompanied by 43% ‘grey compliance’ and 21% ‘grey non-compliance’ (due to insufficient evidence of achieving required carbon emissions reductions). It is a serious concern when building control approves so many dwellings when insufficient evidence of compliance has been received. Underlying issues were centred on: incorrect compilation and/or insufficient submission of carbon emissions calculations by builders/developers; inappropriate timings of such submissions; and a paucity of proper checks by building control. Exploring these issues reveals a complex system of factors influencing energy regulations compliance, which involves a wide range of stakeholders. The findings should inform the formulation and implementation of energy efficiency building regulations and policy in the future. - Highlights: ► The compliance with energy Building Regulations (England and Wales) was poor. ► The problematic implementation of energy Building Regulations is a serious concern. ► Identified issues suggest a lack of knowledge of builders and building control. ► There is a complex system of factors influencing energy regulations compliance. ► A systems approach is needed to improve compliance, while training is crucial.

Regulatory and legal issues

International Nuclear Information System (INIS)

Raisler, K.M.; Gregory, A.M.

1999-01-01

This chapter focuses on the legal issues relating to the derivatives market in the USA, and analyses the Commodity Futures Trading Commission's (CFTCs) information on swaps and hybrid instruments. The law and regulation in the USA is examined and the jurisdictional reach of the Securities and Exchange Commission (SEC), CFTC, and the Commodity Exchange Act (CEA) is described. The forward contract exclusion and the case of Transnor (Bermuda) Ltd. versus BP North America Petroleum, state laws, swap policy statement issues by the CFTC, the Futures Trading Practices Act of 1992, swaps exemptions, the exemption of hybrid instruments from the CEA, and energy contract exemption are discussed. Enforceability, derivatives, and issues before regulators are considered

Alberta Energy and Utilities Board, regulatory highlights for 1998

Energy Technology Data Exchange (ETDEWEB)

NONE

1999-08-01

This new publication informs readers about what the Alberta Energy and Utilities Board (EUB) did in the past year, including important regulatory issues, trends and initiatives. The EUB is an agency of the provincial government, established to regulate Alberta`s energy resource and utility sectors. It is part of the Alberta Ministry of Energy. The four main functions of the Board are regulatory initiatives, license applications, enforcement and information. This publication summarized the EUB`s position regarding flaring (both solution gas flaring and well test flaring), and Board activities in the areas of animal health concerns, the gas over bitumen controversy, the deregulation of the electric industry and what it means to the EUB, improvements in data quality as a result of improved industry compliance in reporting, and a variety of issues related to the oil sands and the negotiated settlement process. Also, the Board has been proactive in the area of oilfield waste management guidelines, proliferation policies for gas processing facilities, sulphur recovery guidelines, and the expansion of the orphan well program to include facilities and pipelines. As a measure of the success of the EUB, a recent survey of 19 randomly selected focus groups praised EUB for its impartiality, fair and equitable enforcement and independence. It was also praised for its technically competent and experienced staff, its access to quality information and the clarity of its mandate, regulatory requirements and processes. The Board`s efforts in the area of timely stakeholder consultation was highlighted. tabs., figs.

Compliance or good control and accountability

International Nuclear Information System (INIS)

Erkkila, B.H.

1993-01-01

DOE Orders and draft orders for nuclear material control and accountability address the need for a complete material control and accountability (MC ampersand A) program for all DOE contractors processing, using, and/or storing nuclear materials. These orders also address performance as well as compliance issues. Very often the existence of a program or an element of a program satisfies the compliance aspect of DOE requirements. The concept of performance requirements is new and requires new thinking with all of the elements of the MC ampersand A program. The contractor is so accustomed to compliance with DOE requirements that dealing with performance is not well understood. In this paper I will address the receptiveness of performance requirements by the contractor. Auditing for performance is also a new concept and has not been implemented. The contractor will have to learn how to measure the performance of the MC ampersand A program and be able to demonstrate a certain level of performance to the oversight organization. This paper will contain a discussion of a well organized MC ampersand A program, the compliance issues associated with the program, the performance criteria associated with the program, and how to audit such a program

Science to compliance: The WIPP success story

International Nuclear Information System (INIS)

Howarth, S.M.; Chu, M.S.; Shephard, L.E.

1997-01-01

The Waste Isolation Pilot Plant (WIPP) in southeast New Mexico has been studied as a transuranic waste repository for the past 23 years. During this time, an extensive site characterization, design, construction, and experimental program was completed to provide in-depth understanding of the dominant processes that are most likely to influence the containment of radionuclides for 10,000 years. The success of the program, however, is defined by the regulator in the context of compliance with performance criteria, rather than by the in-depth technical understanding typical of most scientific programs. The WIPP project was successful in making a transformation from science to compliance by refocusing and redirecting programmatic efforts toward the singular goal of meeting regulatory compliance requirements while accelerating the submittal of the Compliance Certification Application (CCA) by two months from the April 1994 Disposal Decision Plan (DDP) date of December 1996, and by reducing projected characterization costs by more than 40%. This experience is unparalleled within the radioactive waste management community and has contributed to numerous lessons learned from which the entire community can benefit

Directory of certificates of compliance for radioactive materials packages

International Nuclear Information System (INIS)

1992-10-01

This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3), for Radioactive Materials Packages effective October 1, 1992. The purpose of this directory is to make available a convenient source of information on packaging which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volumes 1 and 2. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The reports include a listing of all users of each package-design and approved QA programs prior to the publication date of the directory

Directory of Certificates of Compliance for Radioactive Materials Packages

International Nuclear Information System (INIS)

1992-10-01

This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3), for Radioactive Materials Packages effective October 1, 1992. The purpose of this directory is to make available a convenient source of information on packaging which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volumes 1 and 2. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The reports include a listing of all users of each package-design and approved QA programs prior to the publication date of the directory

20 CFR 604.6 - Conformity and substantial compliance.

Science.gov (United States)

2010-04-01

... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Conformity and substantial compliance. 604.6... FOR ELIGIBILITY FOR UNEMPLOYMENT COMPENSATION § 604.6 Conformity and substantial compliance. (a) In... for the administration of its UC program. (b) Resolving Issues of Conformity and Substantial...

Regulatory analysis for Generic Issue 23: Reactor coolant pump seal failure. Draft report for comment

Energy Technology Data Exchange (ETDEWEB)

Shaukat, S K; Jackson, J E; Thatcher, D F

1991-04-01

This report presents the regulatory/backfit analysis for Generic Issue 23 (GI-23), 'Reactor Coolant Pump Seal Failure'. A backfit analysis in accordance with 10 CFR 50.109 is presented in Appendix E. The proposed resolution includes quality assurance provisions for reactor coolant pump seals, instrumentation and procedures for monitoring seal performance, and provisions for seal cooling during off-normal plant conditions involving loss of all seal cooling such as station blackout. Research, technical data, and other analyses supporting the resolution of this issue are summarized in the technical findings report (NUREG/CR-4948) and cost/benefit report (NUREG/CR-5167). (author)

Legal framework of the environmental regulatory regime

International Nuclear Information System (INIS)

Black, D.

1992-01-01

The growing concern regarding environmental issues has presented a number of new challenges to those exploring and developing the hydrocarbon reserves located on the Newfoundland continental shelf. Not the least of these challenges is the development of new technologies in the harsh environment of the North Atlantic; in addition, these new technologies must be implemented in an existing and ever-changing regulatory regime. The legal framework of the environmental regulatory regime relating to offshore development in Canada is reviewed along with some of the more important legislation involved in regulating environmental issues in the offshore area. The legal basis for exploration, development, and management of resources located on the Newfoundland continental shelf is the Canada-Newfoundland Accord on Joint Management of Offshore Oil and Gas Resources off Newfoundland and Labrador. Administration of the Accord is the responsibility of the Canada-Newfoundland Offshore Petroleum Board. To be able to apply Canadian laws to the continental shelf, legislation was passed including the Canadian Laws Offshore Application Act as well as the Act implementing the Accord. The latter gives the Offshore Petroleum Board authority to regulate all stages involved in bringing an oil pool to production, such as granting of licenses and work authorizations. Granting of such licenses and authorizations is subject to compliance with environmental requirements, and there are provisions against certain environmental offenses such as spills. Other federal legislation applicable to the offshore includes the Canada Shipping Act and the Canadian Environmental Protection Act

Review of EU-APR Design for Selected Safety Issues of WERNA RHWG 2013

Energy Technology Data Exchange (ETDEWEB)

Kim, Yong Soo; Kim, Ji Hwan [KHNP CRI, Daejeon (Korea, Republic of)

2016-10-15

Western European Nuclear Regulators' Association (WENRA) was established in 1999 to develop a harmonized approach to nuclear safety and radiation protection and their regulation. In 2013, the Reactor Harmonization Working Group (RHWG) of WENRA sets out the common positions on the seven selected key safety issues. This paper is to introduce the regulatory positions of WENRA RHWG 2013 and to review the compliance of the EU-APR with them. In this paper, we reviewed the compliance of the EUAPR regarding seven safety issues for new NPPs presented by WERNA RHWG in 2013. The EU-APR design fully complies with all WERNA RHWG safety issues since the following measures have been incorporated in it: - Successive five levels of DiD maintaining independence between different levels of DiD - Diverse design against multiple failure events such as ATWS, SBO, Loss of Ultimate Heat Sink, and Loss of Spent Fuel Pool Cooling - SAs dedicated mitigation systems to ensure the containment integrity during the SAs. - Practically eliminates accident sequences with a large or early release of radiological materials by diverse designs for multiple failure events, SAs dedicated mitigation system, and double containment design - Standard site parameters not lead to core melt accidents due to natural or man-made external hazards.

Compliance assurance for the safe transport of radioactive material. Safety guide

International Nuclear Information System (INIS)

2009-01-01

The objectives of this Safety Guide are to assist competent authorities in the development and maintenance of compliance assurance programmes in connection with the transport of radioactive material, and to assist applicants, licensees and organizations in their interactions with competent authorities. In order to increase cooperation between competent authorities and to promote the uniform application of international regulations and recommendations, it is desirable to adopt a common approach to regulatory activities. This Safety Guide is intended to assist in accomplishing such a uniform application by recommending most of the actions for which competent authorities need to provide in their programmes for ensuring compliance with the Transport Regulations. This Safety Guide addresses radiation safety aspects of the transport of radioactive material; that is, the subjects that are covered by the Transport Regulations. Radioactive material may have other dangerous properties, however, such as explosiveness, flammability, pyrophoricity, chemical toxicity and corrosiveness; these properties are required to be taken into account in the regulatory control of the design and transport of packages. Physical protection and systems for accounting for and control of nuclear material are also discussed in this Safety Guide. These subjects are not within the scope of the Transport Regulations, but information on them is included here because they must be taken into account in the overall regulatory control of transport, especially when the regulatory framework is being established. Section 1 informs about the background, the objective, the scope and the structure of this publication. Section 2 provides recommendations on the responsibilities and functions of the competent authority. Section 3 provides information on the various national and international regulations and guides for the transport of radioactive material. Section 4 provides recommendations on carrying out

Rocky Flats Compliance Program

International Nuclear Information System (INIS)

1994-02-01

The Department of Energy (DOE) established the Office of Technology Development (EM-50) (OTD) as an element of Environmental Restoration and Waste Management (EM) in November 1989. The primary objective of the Office of Technology Development, Rocky Flats Compliance Program (RFCP), is to develop altemative treatment technologies for mixed low-level waste (wastes containing both hazardous and radioactive components) to use in bringing the Rocky Flats Plant (RFP) into compliance with Federal and state regulations and agreements. Approximately 48,000 cubic feet of untreated low-level mixed waste, for which treatment has not been specified, are stored at the RFP. The cleanup of the Rocky Flats site is driven by agreements between DOE, the Environmental Protection Agency (EPA), and the Colorado Department of Health (CDH). Under these agreements, a Comprehensive Treatment and Management Plan (CTMP) was drafted to outline the mechanisms by which RFP will achieve compliance with the regulations and agreements. This document describes DOE's strategy to treat low-level mixed waste to meet Land Disposal Restrictions and sets specific milestones related to the regulatory aspects of technology development. These milestones detail schedules for the development of technologies to treat all of the mixed wastes at the RFP. Under the Federal Facilities Compliance Act (FFCA), the CTMP has been incorporated into Rocky Flats Plant Conceptual Site Treatment Plan (CSTP). The CSTP will become the Rocky Flats Plant site Treatment Plan in 1995 and will supersede the CTMP

Social media in the health-care setting: benefits but also a minefield of compliance and other legal issues.

Science.gov (United States)

Moses, Richard E; McNeese, Libra G; Feld, Lauren D; Feld, Andrew D

2014-08-01

Throughout the past 20 years, the rising use of social media has revolutionized health care as well as other businesses. It allows large groups of people to create and share information, ideas, and experiences through online communications, and develop social and professional contacts easily and inexpensively. Our Gastroenterology organizations, among others, have embraced this technology. Although the health-care benefits may be many, social media must be viewed through a legal lens, recognizing the accompanying burdens of compliance, ethical, and litigation issues. Theories of liability and risk continue to evolve as does the technology. Social media usage within the medical community is fraught with potential legal issues, requiring remedial responses to meet patients' needs and comply with current laws, while not exposing physicians to medical malpractice and other tort risks.

Assessment of public perception and environmental compliance at a pulp and paper facility: a Canadian case study.

Science.gov (United States)

Hoffman, Emma; Bernier, Meagan; Blotnicky, Brenden; Golden, Peter G; Janes, Jeffrey; Kader, Allison; Kovacs-Da Costa, Rachel; Pettipas, Shauna; Vermeulen, Sarah; Walker, Tony R

2015-12-01

Communities across Canada rely heavily on natural resources for their livelihoods. One such community in Pictou County, Nova Scotia, has both benefited and suffered, because of its proximity to a pulp and paper mill (currently owned by Northern Pulp). Since production began in 1967, there have been increasing impacts to the local environment and human health. Environmental reports funded by the mill were reviewed and compared against provincial and federal regulatory compliance standards. Reports contrasted starkly to societal perceptions of local impacts and independent studies. Most environmental monitoring reports funded by the mill indicate some levels of compliance in atmospheric and effluent emissions, but when compliance targets were not met, there was a lack of regulatory enforcement. After decades of local pollution impacts and lack of environmental compliance, corporate social responsibility initiatives need implementing for the mill to maintain its social licence to operate.

Y2K compliance countdown.

Science.gov (United States)

Arlotto, P W

1999-01-01

The new century brings unique challenges--especially Y2K compliance. This article presents nurse managers and executives with an overview of the issues and action steps to keep their organizations on track.

Compliance Framing - Framing Compliance

OpenAIRE

Lutz-Ulrich Haack; Martin C. Reimann

2012-01-01

Corporations have to install various organizational measures to comply with legal as well as internal guidelines systematically. Compliance management systems have the challenging task to make use of an internal compliance-marketing approach in order to ensure not only an adequate but also effective compliance-culture. Compliance-literature and findings of persuasive goal-framing-theory give opposite implications for establishing a rather values- versus rule-based compliance-culture respectiv...

Quality beyond compliance.

Science.gov (United States)

Centanni, N; Monroe, M; White, L; Larson, R

1999-01-01

The service sector within the biopharmaceutical industry has experienced phenomenal growth over the past decade. In the highly regulated Good Laboratory Practices environment, the need for timely, high-quality service, accurate results, and on-time deliverables becomes paramount for the success and profitability of biopharmaceutical companies. The quality assurance process is a vital component of this drug product-development cycle and ensures compliance to the highest domestic and international regulatory standards. Quality-assurance professionals historically have held the role of independent auditors of the processes, who certify that results meet current standards of practice. Covance, a contract research organization that includes Good Laboratory Practices laboratories, reorganized and expanded the functional responsibilities of its quality assurance team in 1997. Auditors and quality assurance professionals have assumed roles beyond traditional compliance auditing and are forging new leadership and mentoring roles as process-improvement specialists. The results have been tangible, measurable benefits for clients and the Covance organization. This article provides an overview of this cultural change and the processes put in place to improve efficiency, productivity, and customer and employee satisfaction.

Radiation practices and regulatory control

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-06-01

The general principles to be observed in the regulatory control of ionizing radiation use and practices are specified in the guide. It also takes into account of additions and alterations needed for for compliance with the European Union (EU) directives that have not been mentioned in other STUK/ST-guides. (6 refs.).

Radiation practices and regulatory control

International Nuclear Information System (INIS)

1997-01-01

The general principles to be observed in the regulatory control of ionizing radiation use and practices are specified in the guide. It also takes into account of additions and alterations needed for for compliance with the European Union (EU) directives that have not been mentioned in other STUK/ST-guides. (6 refs.)

Regulatory compliance in the design of packages used to transport radioactive materials

International Nuclear Information System (INIS)

Raske, D.T.

1993-01-01

Shipments of radioactive materials within the regulatory jurisdiction of the US Department of Energy (DOE) must meet the package design requirements contained in Title 10 of the Code of Federal Regulations, Part 71, and DOE Order 5480.3. These regulations do not provide design criteria requirements, but only detail the approval standards, structural performance criteria, and package integrity requirements that must be met during transport. The DOE recommended design criterion for high-level Category I radioactive packagings is Section III, Division 1, of the ASME Boiler and Pressure Vessel Code. However, alternative design criteria may be used if all the design requirements are satisfied. The purpose of this paper is to review alternatives to the Code criteria and discuss their applicability to the design of containment vessels in packages for high-level radioactive materials. Issues such as design qualification by physical testing, the use of scale models, and problems encountered using a non-ASME design approach are addressed

77 FR 59675 - Compliance With Information Request, Flooding Hazard Reevaluation

Science.gov (United States)

2012-09-28

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0222] Compliance With Information Request, Flooding Hazard... was needed in the areas of seismic and flooding design, and emergency preparedness. In addition to... licensees reevaluate flooding hazards at nuclear power plant sites using updated flooding hazard information...

Regulatory trends in the battery industry

International Nuclear Information System (INIS)

McColl, K.G.

1994-01-01

The scope of regulations in the battery industry is extensive and also complex. In the future, regulations will become more demanding and will encompass issues not currently considered. Increased focus on environmental issues by government bodies, environmental groups, local communities will result in more strict compliance standards. The USA is currently leading the world's battery industries in the scope and compliance level of regulations. By studying trends in the USA, the rest of the battery industry can prepare itself for the future operating environment. This paper reviews the most critical areas of air pollution, blood-lead levels and recycling. The paper concludes that the battery industry must adopt a culture of exceeding current compliance standards. (orig.)

78 FR 55251 - Hydropower Regulatory Efficiency Act of 2013; Notice of Workshop

Science.gov (United States)

2013-09-10

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD13-9-000] Hydropower... hydropower development at non-powered dams and closed-loop pumped storage projects in compliance with section 6 of the Hydropower Regulatory Efficiency Act of 2013. Participants should be prepared to discuss...

Compliance with Segment Disclosure Initiatives

DEFF Research Database (Denmark)

Arya, Anil; Frimor, Hans; Mittendorf, Brian

2013-01-01

Regulatory oversight of capital markets has intensified in recent years, with a particular emphasis on expanding financial transparency. A notable instance is efforts by the Financial Accounting Standards Board that push firms to identify and report performance of individual business units...... (segments). This paper seeks to address short-run and long-run consequences of stringent enforcement of and uniform compliance with these segment disclosure standards. To do so, we develop a parsimonious model wherein a regulatory agency promulgates disclosure standards and either permits voluntary...... by increasing transparency and leveling the playing field. However, our analysis also demonstrates that in the long run, if firms are unable to use discretion in reporting to maintain their competitive edge, they may seek more destructive alternatives. Accounting for such concerns, in the long run, voluntary...

Self-Regulated Compliance in Preschoolers with Autism Spectrum Disorder: The Role of Temperament and Parental Disciplinary Style

Science.gov (United States)

Ostfeld-Etzion, Sharon; Feldman, Ruth; Hirschler-Guttenberg, Yael; Laor, Nathaniel; Golan, Ofer

2016-01-01

Regulatory difficulties are common in children with autism spectrum disorder. This study focused on an important aspect of self-regulation--the ability to willingly comply with frustrating demands of socialization agents, termed "self-regulated compliance." We studied compliance to parental demands in 40 preschoolers with autism spectrum…

Federal facilities compliance act waste management

International Nuclear Information System (INIS)

Bowers, J.; Gates-Anderson, D.; Hollister, R.; Painter, S.

1999-01-01

Site Treatment Plans (STPs) developed through the Federal Facilities Compliance Act pose many technical and administrative challenges. Legacy wastes managed under these plans require Land Disposal Restriction (LDR) compliance through treatment and ultimate disposal. Although capacity has been defined for most of the Department of Energy wastes, many waste streams require further characterization and many need additional treatment and handling beyond LDR criteria to be able to dispose of the waste. At Lawrence Livermore National Laboratory (LLNL), the Hazardous Waste Management Division has developed a comprehensive Legacy Waste Program. The program directs work to manage low level and mixed wastes to ensure compliance with nuclear facility rules and its STP. This paper provides a survey of work conducted on these wastes at LLNL. They include commercial waste treatment and disposal, diverse forms of characterization, inventory maintenance and reporting, on-site treatment, and treatability studies. These activities are conducted in an integrated fashion to meet schedules defined in the STP. The processes managing wastes are dynamic due to required integration of administrative, regulatory, and technical concerns spanning the gamut to insure safe proper disposal

POWER-GEN '90 conference papers: Volume 3 (Environmental trends and issues) and Volume 4 (Case histories - Non-utility power generation)

International Nuclear Information System (INIS)

Anon.

1990-01-01

This is book 2 of a collection of papers presented at the Third International Power Generation Industries Conference on December 4-6, 1990. The book contains Volume 3, Environmental Trends and Issues, and Volume 4, Case Histories - Non-utility Power Generation. The topics of the papers include environmental legislative and regulatory trends, acid rain compliance strategies and technologies, other global environmental concerns, gas fired systems, solid and waste fuels, despatching and wheeling, and strategies for purchasing non-utility power

Organization and staffing of the regulatory body for nuclear facilities. Safety guide

International Nuclear Information System (INIS)

2005-01-01

The purpose of this safety guide is to provide recommendations for national authorities on the appropriate management system, organization and staffing for the regulatory body responsible for the regulation of nuclear facilities in order to achieve compliance with the applicable safety requirements. This safety guide covers the organization and staffing in relation to nuclear facilities such as: enrichment and fuel manufacturing plants. Nuclear power plants. Other reactors such as research reactors and critical assemblies. Spent fuel reprocessing plants. And radioactive waste management facilities such as treatment, storage and disposal facilities. This safety guide also covers issues related to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation

The Regulatory Flexibility Act: Implementation Issues and Proposed Reforms

National Research Council Canada - National Science Library

Copeland, Curtis W

2008-01-01

...; the projected reporting, recordkeeping, and other compliance requirements of the rule; and any significant alternatives to the rule that would accomplish the statutory objectives while minimizing the impact on small entities...

75 FR 18200 - Enterprise Texas Pipeline LLC; Notice of Compliance Filing

Science.gov (United States)

2010-04-09

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR07-12-005] Enterprise..., Enterprise Texas Pipeline LLC (Enterprise Texas), filed its Statement of Operating Conditions in compliance... Commission's regulations. Enterprise Texas states that the revisions include modifications consistent with...

75 FR 18496 - Enterprise Texas Pipeline LLC; Notice of Compliance Filing

Science.gov (United States)

2010-04-12

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR07-12-005] Enterprise..., Enterprise Texas Pipeline LLC (Enterprise Texas), filed its Statement of Operating Conditions in compliance... Commission's regulations. Enterprise Texas states that the revisions include modifications consistent with...

78 FR 24439 - Compliance With Information Request, Flooding Hazard Reevaluation

Science.gov (United States)

2013-04-25

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0073] Compliance With Information Request, Flooding Hazard... Estimating Flooding Hazards due to Dam Failure.'' This draft JLD-ISG provides guidance acceptable to the NRC staff for reevaluating flooding hazards due to dam failure for the purpose of responding to enclosure 2...

The IAEA Integrated Regulatory Review Service (IRRS) - Information Meeting Dublin

International Nuclear Information System (INIS)

Al Khatibeh, Ahmad

2014-05-01

IRRS is developed to help States evaluate the current status of compliance of their regulatory infrastructures for safety with IAEA Standards. This report discusses the function of IRRS missions as a tool for evaluating the regulatory structure for Member States. It was presented to RPII staff in a Powerpoint document in preparation for the IRRS Mission to Ireland in August 2015

Compliance officers and legal advisers in power supply companies. interactions between compliance, risk management and the employer-employee relationship; Compliance-Beauftragte und Justitiare in EVU. Wechselwirkungen von Compliance, Risikomanagement und Arbeitsverhaeltnis

Energy Technology Data Exchange (ETDEWEB)

Gold, Juergen [Sozietaet Becker Buettner Held, Muenchen (Germany); Schaefer, Ralf; Bussmann, Sandra [Sozietaet Becker Buettner Held, Koeln (Germany)

2011-06-15

An inevitable task of any employee who has been appointed compliance officer, head of the legal department or internal auditor is to ensure that the company is protected against detriment through breaches of law or regulations. Another of his or her tasks, however, and one which might not be as obvious, is to ensure that parties outside the company are protected against detriment through his or her own employer. In order to deal appropriately with these and related questions some basic considerations on the necessity and function of compliance surveillance and its relationship with risk management must first be made. Using two significant court decisions for illustration the authors make a close examination of the liability issues involved in this area of potential conflict. They identify some salient points which should be considered in framing the contractual relationship between a compliance officer and his or her employer.

Are Lead Exposures a Risk in European Fresh Waters? A Regulatory Assessment Accounting for Bioavailability.

Science.gov (United States)

Peters, Adam; Wilson, Iain; Merrington, Graham; Chowdhury, M Jasim

2018-01-01

An indicative compliance assessment of the Europe-wide bioavailable lead Environmental Quality Standard of 1.2 µg L -1 (EQS) was undertaken against regulatory freshwater monitoring data from six European member states and FOREGS database. Bio-met, a user-friendly tool based upon Biotic Ligand Models (BLMs) was used to account for bioavailability, along with the current European Water Framework Directive lead dissolved organic carbon correction approach. The outputs from both approaches were compared to the BLM. Of the 9054 freshwater samples assessed only 0.6% exceeded the EQS of 1.2 µg L -1 after accounting for bioavailability. The data showed that ambient background concentrations of lead across Europe are unlikely to influence general compliance with the EQS, although there may be isolated local issues. The waters showing the greatest sensitivity to potential lead exposures are characterized by relatively low DOC (< 0.5 mg L -1 ), regardless of the pH and calcium concentrations.

Canadian consumer issues in accurate and fair electricity metering

International Nuclear Information System (INIS)

2000-07-01

The Public Interest Advocacy Centre (PIAC), located in Ottawa, participates in regulatory proceedings concerning electricity and natural gas to support public and consumer interest. PIAC provides legal representation, research and policy support and public advocacy. A study aimed toward the determination of the issues at stake for residential electricity consumers in the provision of fair and accurate electricity metering, was commissioned by Measurement Canada in consultation with Industry Canada's Consumer Affairs. The metering of electricity must be carried out in a fair and efficient manner for all residential consumers. The Electricity, Gas and Inspection Act was developed to ensure compliance with standards for measuring instrumentation. The accurate metering of electricity through the distribution systems for electricity in Canada represents the main focus of this study and report. The role played by Measurement Canada and the increased efficiencies of service delivery by Measurement Canada or the changing of electricity market conditions are of special interest. The role of Measurement Canada was explained, as were the concerns of residential consumers. A comparison was then made between the interests of residential consumers and those of commercial and industrial electricity consumers in electricity metering. Selected American and Commonwealth jurisdictions were reviewed in light of their electricity metering practices. A section on compliance and conflict resolution was included, in addition to a section on the use of voluntary codes for compliance and conflict resolution

Regulatory control of nuclear safety in Finland. Annual report 1998

Energy Technology Data Exchange (ETDEWEB)

Tossavainen, K. [ed.

1999-10-01

The report describes regulatory control of the safe use of nuclear energy by the Radiation and Nuclear Safety Authority (STUK) in 1998. STUK is the Finnish nuclear safety authority. The submission of this report to the Ministry of Trade and Industry is stipulated in Section 121 of the Nuclear Energy Decree. It was verified by regulatory control that the operation of Finnish NPPs was in compliance with conditions set out in the operating licences of the plants and with regulations currently in force. In addition to supervising the normal operation of the plants, STUK oversaw projects carried out at the plant units, which related to the uprating of their power and the improvement of their safety. STUK issued to the Ministry of Trade and Industry a statement about applications for the renewal of the operating licences of Loviisa and Olkiluoto NPPs, which had been submitted by Imatran Voima Oy and Teollisuuden Voima Oy. Regulatory activities in the field of nuclear waste management were focused on the storage and final disposal of spent fuel as well as the treatment, storage and final disposal of reactor waste. STUK issued a statement to the Ministry of Trade and Industry about an environmental impact assessment programme pertaining to a spent fuel repository project, which had been submitted by Posiva Oy, as well as on Imatran Voima Oy's application concerning the operation of a repository for medium- and low-level reactor waste from Loviisa NPP. The use of nuclear materials was in compliance with the regulations currently in force and also the whereabouts of every batch of nuclear material were ensured by safeguards control. In international safeguards, important changes took place, which were reflected also in safeguards activities at national level. International co-operation continued based on financing both from STUK's budget and from additional sources. The focus of co-operation funded from outside sources was as follows: improvement of the safety of

Regulatory control of nuclear safety in Finland. Annual report 1998

International Nuclear Information System (INIS)

Tossavainen, K.

1999-10-01

The report describes regulatory control of the safe use of nuclear energy by the Radiation and Nuclear Safety Authority (STUK) in 1998. STUK is the Finnish nuclear safety authority. The submission of this report to the Ministry of Trade and Industry is stipulated in Section 121 of the Nuclear Energy Decree. It was verified by regulatory control that the operation of Finnish NPPs was in compliance with conditions set out in the operating licences of the plants and with regulations currently in force. In addition to supervising the normal operation of the plants, STUK oversaw projects carried out at the plant units, which related to the uprating of their power and the improvement of their safety. STUK issued to the Ministry of Trade and Industry a statement about applications for the renewal of the operating licences of Loviisa and Olkiluoto NPPs, which had been submitted by Imatran Voima Oy and Teollisuuden Voima Oy. Regulatory activities in the field of nuclear waste management were focused on the storage and final disposal of spent fuel as well as the treatment, storage and final disposal of reactor waste. STUK issued a statement to the Ministry of Trade and Industry about an environmental impact assessment programme pertaining to a spent fuel repository project, which had been submitted by Posiva Oy, as well as on Imatran Voima Oy's application concerning the operation of a repository for medium- and low-level reactor waste from Loviisa NPP. The use of nuclear materials was in compliance with the regulations currently in force and also the whereabouts of every batch of nuclear material were ensured by safeguards control. In international safeguards, important changes took place, which were reflected also in safeguards activities at national level. International co-operation continued based on financing both from STUK's budget and from additional sources. The focus of co-operation funded from outside sources was as follows: improvement of the safety of Kola and

Compliance with Environmental and Social Legislation in Certified Forestry Companies

Directory of Open Access Journals (Sweden)

Marcos Vinicius Santana Leite

2017-12-01

Full Text Available ABSTRACT The objective of this study was to evaluate the contribution of the FSC forestry certification system to improve the forestry sector, in terms of compliance to environmental and social laws and improvements in working conditions resulting from the certification process. Thirty-seven auditing reports from five Brazilian forestry companies were evaluated, throughout the 2006-2013 period. Non-compliance and observations were analyzed and organized into categories, which identified the main performance issues found in certified forestry organizations. 301 instances of non-compliance and 138 observations of audit reports were verified, where 48 and 57% respectively, were linked to the two principles studied. For obtaining and/or maintaining the certificate it is necessary for all violations to be resolved. Therefore, it was concluded that forest certification contributes to the advancement of the forestry sector in Brazil, in relation to compliance with legal, social and labor issues.

THE EFFECT OF TAX SIMPLIFICATION ON TAXPAYERS’ COMPLIANCE BEHAVIOR: RELIGIOSITY AS MODERATING VARIABLE

Directory of Open Access Journals (Sweden)

Muslichah Muslichah

2017-03-01

Full Text Available Tax compliance was an important issue for nations around the world as governments searched for revenue tomeet public needs. The importance of tax simplification had long been known as a determinant of compliancebehavior and it became an important issue in taxation research. The primary objective of this study was toinvestigate the effect of tax simplification and religiosity on compliance behavior. This study was conducted inMalang, East Java. Survey questionnaires were sent to 200 taxpayers and only 122 responded. Consistentwith the prior research, this study suggested that the effect of religiosity on compliance behavior was positiveand significant. Religiosity acted as moderating role on the relationship between tax simplification andcompliance behavior. This study was contributed to the compliance literature. The present study also providedpractical significance because the empirical result provided information about compliance behavior to helpgovernment to develop strategies toward increasing voluntary compliance.

Netherlands Electricity Regulatory Service DTe. Internet site

International Nuclear Information System (INIS)

1999-01-01

The implementation of the Dutch Electricity Law and the observance of compliance with the law is commissioned to the Netherlands Electricity Regulatory Service DTe. Their Internet site contains several full-text documents related to the tasks of DTe (mainly with respect to tariffs and transportation of electricity)

Marketing of breast-milk substitutes in Zambia: evaluation of compliance to the international regulatory code.

Science.gov (United States)

Funduluka, P; Bosomprah, S; Chilengi, R; Mugode, R H; Bwembya, P A; Mudenda, B

2018-03-01

We sought to assess the level of non-compliance with the International Code of Marketing breast-milk substitutes (BMS) and/or Statutory Instrument (SI) Number 48 of 2006 of the Laws of Zambia in two suburbs, Kalingalinga and Chelstone, in Zambia. This was a cross sectional survey. Shop owners (80), health workers (8) and mothers (214) were interviewed. BMS labels and advertisements (62) were observed. The primary outcome was mean non-compliance defined as the number of article violations divided by the total 'obtainable' violations. The score ranges from 0 to 1 with 0 representing no violations in all the articles and one representing violations in all the articles. A total of 62 BMS were assessed. The mean non-compliance score by manufacturers in terms of violations in labelling of BMS was 0.33 (SD = 0.28; 95% CI: 0.26, 0.40). These violations were mainly due to labels containing pictures or graphics representing an infant. 80 shops were also assessed with mean non-compliance score in respect of violations in tie-in-sales, special display, and contact with mothers at the shop estimated as 0.14 (SD = 0.14; 95% CI: 0.11, 0.18). Non-compliance with the Code and/or the local SI is high after 10 years of domesticating the Code.

Patient compliance with drug therapy in schizophrenia. Economic and clinical issues.

Science.gov (United States)

Lindström, E; Bingefors, K

2000-08-01

The effectiveness of drug treatment in clinical practice is considerably lower than the efficacy shown in controlled studies. The lower effectiveness in practice presumably leads to lower cost effectiveness of drug treatment in real-life situations compared with that demonstrated by studies based on results from controlled trials. Improved cost effectiveness in routine clinical practice would be a significant advantage in the treatment of schizophrenia, one of the most costly diseases in society. The aetiology of schizophrenia is unknown, and there is no cure. The main aims of therapy with antipsychotic medication include the effective relief of symptoms without the introduction of adverse effects or serious adverse events, improved quality of life, cost effectiveness and a positive long term outcome. The older classical antipsychotic drugs do not always meet these requirements because of their well-known limitations, such as a lack of response in a subgroup of individuals with schizophrenia and intolerable adverse effects. There has long been a need for new antipsychotics that can ameliorate more symptoms and have no or few adverse effects. Some of the recently introduced antipsychotics have been shown to be more effective in certain clinical situations and to have a more favourable adverse effect profile than the classical antipsychotics. A major factor contributing to the lower effectiveness of drug treatment is noncompliance, which may be very high in schizophrenia. There are several factors influencing compliance, including drug type and formulation, patient, disease status, physician, health care system, community care and family. There have been very few studies of compliance improvement strategies in schizophrenia or, indeed, in medicine in general. Current methods are relatively complex and there are differing opinions on their effectiveness. There are several ways to increase compliance in schizophrenia--the evidence is strongest for psychoeducative

78 FR 58535 - Hydropower Regulatory Efficiency Act of 2013; Supplemental Notice of Workshop

Science.gov (United States)

2013-09-24

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD13-9-000] Hydropower... license for hydropower development at non-powered dams and closed-loop pumped storage projects in compliance with section 6 of the Hydropower Regulatory Efficiency Act of 2013. The workshop will be held in...

Development of guidance on applications of regulatory requirements for regulating large, contaminated equipment and large decommissioning and decontamination (D and D) components

International Nuclear Information System (INIS)

Pope, R.B.; Easton, E.P.; Cook, J.R.; Boyle, R.W.

1997-01-01

In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant were major changes to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). As these requirements were adopted into regulations in the United States, it was recognised that guidance on how to apply these requirements to large, contaminated/activated pieces of equipment and decommissioning and decontamination (D and D) objects would be needed both by the regulators and those regulated to clarify technical uncertainties and ensure implementation. Thus, the US Department of Transportation and the US Nuclear Regulatory Commission, with assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance which will present examples of acceptable methods for demonstrating compliance with the revised rules for large items. Concepts being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment before final issuance in 1997. (Author)

Development of guidance on applications of regulatory requirements for regulating large, contaminated equipment and large decommissioning and decontamination (D and D) components

International Nuclear Information System (INIS)

Pope, R.B.; Easton, E.P.; Cook, J.R.; Boyle, R.W.

1997-01-01

In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant were major changes to requirements for Low Specific Activity material and Surface Contaminated Objects. As these requirements were adopted into regulations in the US, it was recognized that guidance on how to apply these requirements to large, contaminated/activated pieces of equipment and decommissioning and decontamination objects would be needed both by the regulators and those regulated to clarify technical uncertainties and ensure implementation. Thus, the US Department of Transportation and the US Nuclear Regulatory Commission, with assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance which will present examples of acceptable methods for demonstrating compliance with the revised rules for large items. Concepts being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment before final issuance in 1997

Regulatory compliance guide for DOT-7A type A packaging design

International Nuclear Information System (INIS)

Kelly, D.L.

1996-01-01

The purpose of this guide is to provide instruction for assuring that the regulatory design requirements for a DOT-7A Type A packaging are met. This guide also supports the testing and evaluation activities that are performed on new packaging designs by a DOE-approved test facility through the DOE's DOT-7A Test Program. This Guide was updated to incorporate regulatory changes implemented by HM-169A (49 CFR, 'Transportation')

Decommissioning: Regulatory activities and identification of key organizational and human factors safety issues

International Nuclear Information System (INIS)

Durbin, N.E.; Melber, B.D.; Lekberg, A.

2001-12-01

In the late 1990's the Swedish government decided to shut down Unit 1 of the Barsebaeck nuclear power plant. This report documents some of the efforts made by the Swedish Nuclear Power Inspectorate (SKI) to address human factors and organizational issues in nuclear safety during decommissioning of a nuclear facility. This report gives a brief review of the background to the decommissioning of Barsebaeck 1 and points out key safety issues that can arise during decommissioning. The main regulatory activities that were undertaken were requirements that the plant provide special safety reports on decommissioning focusing on first, the operation of both units until closure of Unit 1 and second, the operation of Unit 2 when Unit 1 was closed. In addition, SKI identified areas that might be affected by decommissioning and called these areas out for special attention. With regard to these areas of special attention, SKI required that the plant provide monthly reports on changing and emerging issues as well as self-assessments of the areas to be addressed in the special safety reports. Ten key safety issues were identified and evaluated with regard to different stages of decommissioning and with regard to the actions taken by Barsebaeck. Some key conclusions from SKI's experience in regulating a decommissioning nuclear power plant conclude the report

76 FR 73618 - Enterprise Texas Pipeline LLC; Notice of Compliance Filing

Science.gov (United States)

2011-11-29

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. PR11-92-001] Enterprise Texas Pipeline LLC; Notice of Compliance Filing Take notice that on November 22, 2011, Enterprise Texas Pipeline LLC (Enterprise Texas) filed a revised Statement of Operating Conditions to comply with a...

American Health Information Management Association. Position statement. Issue: managing health information in facility mergers and acquisitions.

Science.gov (United States)

1994-04-01

Healthcare facility mergers and acquisitions are becoming more common as the industry consolidates. Many critical issues must be considered in mergers and acquisitions, including the management of patient health information. In addition to operational issues, licensure, regulatory, and accreditation requirements must be addressed. To ensure availability of health information to all legitimate users, patient records should be consolidated or linked in the master patient index. A record retention policy should be developed and implemented to meet user needs and assure compliance with legal, regulatory, and accreditation requirements. If health information from closed facilities will be stored for a period of time, its integrity and confidentiality must be preserved, and it must be readily accessible for patient care. The compatibility and functionality of existing information systems should be assessed, and a plan should be formulated for integration of the systems to the extent possible. Such integration may be essential for the organization to successfully meet the demands of integrated delivery systems. Existing databases should be maintained in an accessible form to meet anticipated future needs.

Regulatory Safety Issues in the Structural Design Criteria of ASME Section III Subsection NH and for Very High Temperatures for VHTR & GEN IV

Energy Technology Data Exchange (ETDEWEB)

William J. O’Donnell; Donald S. Griffin

2007-05-07

The objective of this task is to identify issues relevant to ASME Section III, Subsection NH [1], and related Code Cases that must be resolved for licensing purposes for VHTGRs (Very High Temperature Gas Reactor concepts such as those of PBMR, Areva, and GA); and to identify the material models, design criteria, and analysis methods that need to be added to the ASME Code to cover the unresolved safety issues. Subsection NH was originally developed to provide structural design criteria and limits for elevated-temperature design of Liquid Metal Fast Breeder Reactor (LMFBR) systems and some gas-cooled systems. The U.S. Nuclear Regulatory Commission (NRC) and its Advisory Committee for Reactor Safeguards (ACRS) reviewed the design limits and procedures in the process of reviewing the Clinch River Breeder Reactor (CRBR) for a construction permit in the late 1970s and early 1980s, and identified issues that needed resolution. In the years since then, the NRC and various contractors have evaluated the applicability of the ASME Code and Code Cases to high-temperature reactor designs such as the VHTGRs, and identified issues that need to be resolved to provide a regulatory basis for licensing. This Report describes: (1) NRC and ACRS safety concerns raised during the licensing process of CRBR , (2) how some of these issues are addressed by the current Subsection NH of the ASME Code; and (3) the material models, design criteria, and analysis methods that need to be added to the ASME Code and Code Cases to cover unresolved regulatory issues for very high temperature service.

Issues facing the management of radioactively contaminated lead within the DOE system

International Nuclear Information System (INIS)

Gilmore, M.C.; Kent, S.H.

1993-01-01

The purpose of this paper is to discuss and evaluate the issues that managing and operating contractors in the US DOE system should consider that are associated with management of radioactively contaminated elemental lead. There are many instances where DOE contaminated lead fall within Resource Conservation and Recovery Act (RCRA) regulation. In light of the Federal Facilities Compliance Act (FFCA), it is becoming increasingly important for additional regulatory options to be explored in order to facilitate proper treatment, storage and disposal of RCRA regulated lead. Various DOE facilities have initiated processes to reuse or recycle contaminated lead. Technologies such as melt-refining, surface blasting, and electromigration are being explored. One or more of these technologies may be the key to reducing contaminated lead inventories in the DOE system. Many DOE facilities are finding that these efforts need to have stringent regulatory evaluation since some alternatives have proven to be environmentally desirable but not economically feasible

ENSI’s regulatory framework strategy

International Nuclear Information System (INIS)

2015-03-01

This short brochure issued by the Swiss Federal Nuclear Safety Inspectorate ENSI defines the organisation’s regulatory framework strategy. Six guiding principles are declared and discussed: Comprehensive harmonisation with relevant international requirements, basing the regulatory framework on existing, tried-and-tested regulations, issuing of its own guidelines only when it is necessary to do so, guidelines to be drawn up transparently and with the involvement of all stakeholders and basing the level of detail of its regulatory framework on hazard potential and risk

Cybersecurity Challenges and Compliance Issues within the U.S. Healthcare Sector

Directory of Open Access Journals (Sweden)

Derek Mohammed

2015-02-01

Full Text Available Increasingly there are security breaches in U.S. Healthcare organizations that result in billions of dollars of damage to the healthcare system and a high personal cost to individuals whose identifiable and private information is unprotected. The Privacy Act of 1974, Health Insurance Portability and Accountability Act (HIPAA, and Health Information Technology for Economic and Clinical Health Act (HITECH are three prominent Acts by the federal government that regulate and protect the confidentiality of personal information in the Healthcare system against breaches. This is a case study examining three organizations in the Healthcare Sector using document analysis to ascertain the problems that resulted in information breaches and the consequences of such breaches. It indicates the failures that occur with the inadequate compliance to the above federal Acts and provides recommendations to control future breaches from occurring. The organizations examined are:  The Veterans Administration which lacked basic security controls, the Utah Department of Technology Service that failed to control their personally identifiable information, and private healthcare organizations which revealed shortcomings in HIPAA compliance after data breach disclosures or random audits. Each case results from a lack of proper protection on systems and equipment containing sensitive data. The study recommendations include the need for organizations to lead by example as well as the establishment of tighter regulations and enforcement measures relating to civil fines, and audits to review organizational compliance with federal laws.

WIPP Regulatory Compliance Strategy and Management Plan for demonstrating compliance to long-term disposal standards

International Nuclear Information System (INIS)

1994-05-01

The primary purpose of this document is to provide a strategy by which the WIPP will demonstrate its ability to perform as a deep geologic repository. The document communicates the DOE's understanding of the regulations related to long-term repository performance; and provides the most efficient strategy that intergrates WIPP Project elements, ensures the sufficiency of information, and provides flexibility for changes in the TRU waste generation system to facilitate the disposal of defense-generated TRU wastes. In addition, this document forms a focal point between the DOE and its various external regulators as well as other stakeholders for the purpose of arriving at compliance decisions that consider all relevant input

75 FR 45130 - Draft Compliance Policy Guide Sec. 690.800 Salmonella

Science.gov (United States)

2010-08-02

... humans, such as pet food and pet treats, contaminated with Salmonella and also on regulatory policy... Compliance Policy (HFC-230), Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send two self-addressed adhesive labels to assist that office in processing your...

Characterizing costs and benefits of uncertain future regulatory requirements on the U.S. natural gas industry

International Nuclear Information System (INIS)

Godec, M.L.; Smith, G.E.; Fitzgibbon, T.

1995-01-01

Environmental regulatory requirements at both the state and federal level are constantly changing, making it difficult for industry and R ampersand D program managers to project future compliance requirements and costs. Even if a company is trying to keep abreast of various proposed regulatory initiatives, the number of possible combinations of initiatives that could occur in the future seems virtually limitless. Uncertainty associated with potential future environmental compliance requirements makes the identification and evaluation of future investment and R ampersand D opportunities exceedingly difficult, and makes the process of systematic strategic planning increasingly complex. This paper describes a methodology for accounting for uncertain future environmental compliance costs in a systematic, comprehensive manner. Through analysis of proposed initiatives for making future environmental requirements more stringent, forecasting the likelihood of occurrence and potential timing of each initiative, and estimating potential future compliance costs associated with each initiative, a thorough process for incorporating regulatory uncertainty into strategic planning and project evaluation is described. This approach can be used for evaluating R ampersand D opportunities to determine where development of new technologies or assessment of risks posed by industry operations may have the greatest impact on future industry costs of compliance. This approach could also be used to account for the uncertainty of future environmental costs in corporate strategic planning or for factoring future compliance costs into project evaluation. This approach could also be enhanced through use in conjunction with other modeling and forecasting systems that could consider a broad range of impacts, including impacts on gas production, industry activity levels, and tax revenues

Motivational Postures and Compliance with Environmental Law in Australian Agriculture

Science.gov (United States)

Bartel, Robyn; Barclay, Elaine

2011-01-01

Motivational posture theory is applied and extended to the context of Australian agriculture and environmental regulation. Regulatory failure in this area has been observed but little was known of the compliance attitudes and behaviours of farmers prior to this study. Agriculture covers over 60% of Australia's land surface so this information is…

The legal, regulatory and safety basis for opening WIPP

International Nuclear Information System (INIS)

Dials, G.E.

1997-01-01

Current laws in the United States of America direct the U.S. Department of Energy (DOE) to site, design, operate, and decommission a deep geological repository for safe disposal of transuranic radioactive waste (TRUW) at the Waste Isolation Pilot Plant (WIPP) site. In 1993, the DOE established the Carlsbad Area Office (CAO) to integrate the nation's management of TRUW and to open the WIPP site for safe disposal of TRUW in compliance with applicable laws and regulations. The CAO submitted the final Compliance Certification Application (CCA) in 1996, and is on schedule to open WIPP in November 1997, about three years earlier than scheduled before the establishment of the CAO. The performance assessment (PA) embodied in the CCA demonstrates that WIPP meets the EPA's regulatory requirements for radioactive releases for the 10,000 year regulatory period in both the undisturbed and disturbed (human intrusion) scenarios. Detailed planning, compliance-based research and development (R and D), teamwork among project participants and early and open iterative interactions with the regulators, oversight groups and other interested parties in the certification/permitting process are key components of the progress in the safe disposal of long-lived radioactive wastes. (author)

Directory of certificates of compliance for radioactive materials packages: Summary report of NRC approved packages

International Nuclear Information System (INIS)

1987-11-01

This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1). This directory makes available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the back of Volume 1

The regulatory control of radioactive sources in Argentina

International Nuclear Information System (INIS)

Rojkind, Roberto Hector

1997-01-01

Argentina has been conducting nuclear activities for more than forty years, and as early as in 1956 established a Regulatory Authority. Procedures for compliance monitoring and enforcement have been in use in the regulatory control of radioactive sources, and regulatory standards and regulations had been set in Argentina, before the accident in Goiania. The conclusions drawn from that accident encouraged in Argentina the improvement of some regulatory procedures and helped to enhance the quality of the regulatory process. Therefore, the effectiveness of the control of spent radioactive sources has gradually increased, and enforcement actions to prevent radioactive sources ending up in the public domain improved. Some lessons learned in Argentina from the accident in Goiania and the main characteristics of an effective enforcement program helpful to prevent radiological accidents in industrial, medical, research and teaching uses of radioactive sources are presented. (author)

75 FR 47666 - Self-Regulatory Organizations; National Futures Association; Notice of Filing and Immediate...

Science.gov (United States)

2010-08-06

... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-62624; File No. SR-NFA-2010-02] Self-Regulatory... Interpretive Notice Entitled ``NFA Compliance Rule 2-30(b): Risk Disclosure Statement for Security Futures... President and General Counsel, NFA, dated July 26, 2010. I. Self-Regulatory Organization's Description of...

Future nuclear regulatory challenges. A report by the NEA Committee on Nuclear Regulatory Activities

International Nuclear Information System (INIS)

1998-01-01

Future challenges are considered that may arise from technical, socio-economic and political issues; organizational, management and human aspects; and international issues. The perceived challenges have been grouped into four categories, each covered by a chapter. Technical issues are addressed that many present regulatory challenges in the future: ageing nuclear power plants. External changes to industry are considered next that have an effect on regulators, privatization, cost reduction consequences, commercialization etc. It is followed by the impacts of internal changes: organizational, managerial, human-resources, licensing, staff training etc. Finally, international issues are discussed with potential regulatory impact. (R.P.)

Debatable Issues of Regulatory Policy of Russian Nanoindustry

Directory of Open Access Journals (Sweden)

Frolov Daniil Petrovich

2015-05-01

Full Text Available The article studies the debatable issues of regulatory policy in the sphere of nanoindustry. The nanotech industry has interindustry character that is caused by interdisciplinarity of a nanoscience therefore it is necessary to recognize objectively impossible exact definition of its branch structure. As a result of terminological uncertainty, the state support and regulation of nanotech industry is a difficult process. The substantial expansionism of the term “nanotechnology” and metaphorism of the concept “nanoindustry” is reasoned. The need of creating more detailed classification (by 1-2 orders of nanotechnologies and allocation of at least three subindustries of nanotech industry is proved. The deficiency of convergent orientation of policy of regulation of the Russian hi-tech industries is revealed. The conceptual discrepancy of nanoindustrial policy of the Russian Federation combining elements of traditional policy of import substitution and new industrial policy is shown. The expediency of transition from universal policy of nanoindustry regulation to the development of a package of the segment-focused strategies of development of different types of nanotechnologies and the nanotechnological activities is proved. The special attention is paid to a safety control problem (combination of obligatory certification and voluntary marking of nanoproduction, strengthening the role of nanotech industry self-regulation and active integration of stakeholders into the system of strategic planning.

Higher Education IT Compliance through the Prism of Risk Controls

Science.gov (United States)

Feehan, Patrick J.

2013-01-01

In 2013, compliance issues march, unceasingly, through every aspect of higher education. Yet the intricacies of privacy, information security, data governance, and IT policy as compliance and risk areas within the IT organization can reverberate and impact every other department within the higher education institution. The primary focus is always…

Licensing and regulatory control of nuclear power plants in Canada

International Nuclear Information System (INIS)

Atchison, R.J.

1975-01-01

The paper discusses the safety philosophy adopted in Canada, the safety criteria and regulatory requirements necessary for the application of this philosophy to reactor design and operation, and finally the means by which compliance with Board requirements is effected. It is emphasized that the effectiveness of regulatory control depends not only on the underlying philosophy but also on the detailed way in which it is applied. (orig./HP) [de

76 FR 13610 - Enterprise Texas Pipeline LLC; Notice of Compliance Filing

Science.gov (United States)

2011-03-14

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. PR10-14-002; PR11-92-000] Enterprise Texas Pipeline LLC; Notice of Compliance Filing Take notice that on March 1, 2011, Enterprise Texas Pipeline LLC (Enterprise Texas) filed a revised Statement of Rates to its Statement of Operating...

75 FR 28602 - Corning Natural Gas Corporation; Notice of Compliance Filing

Science.gov (United States)

2010-05-21

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR09-30-003] Corning Natural Gas Corporation; Notice of Compliance Filing May 17, 2010. Take notice that on May 10, 2010, Corning Natural Gas Corporation, (Corning) filed a corrected rate sheet to replace the rate sheet filed with its...

Vitrification of underground storage tanks: Technology development, regulatory issues, and cost analysis

International Nuclear Information System (INIS)

Tixier, J.S.; Corathers, L.A.; Anderson, L.D.

1992-03-01

In situ vitrification (ISV), developed by the Pacific Northwest Laboratory (PNL) for the US Department of Energy (DOE), is a thermal treatment process for the remediation of hazardous, radioactive, or mixed waste sites. The process has been broadly patented both domestically and abroad. Since the inception of ISV in 1980, developmental activities have been focused on applications to contaminated soils, and more recently the potential for application to buried wastes and underground structures (tanks). Research performed to date on the more advanced ISV applications (i.e., application to buried wastes and underground tanks) shows that significant technical and economic potential exists for using ISV to treat buried wastes and underground structures containing radionuclides and/or hazardous constituents. Present ISV applications are directed to the treatment of contaminated soils; the likelihood of using ISV to treat underground tanks depends on the resolution of significant technical and institutional issues related to this advanced application. This paper describes the ISV process and summarizes the technical progress of underground tank vitrification (UTV), discusses pertinent regulatory issues facing the use of UTV, and presents the potential cost of UTV relative to other remedial action alternatives

Directory of certificates of compliance for radioactive materials packages: certificates of compliance. Volume 2, Revision 7

International Nuclear Information System (INIS)

1984-11-01

This directory contains a Summary Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Summary Report of NRC Approved Quality Assurance Programs for Radioactive Material Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program. Copies of the current approval may be obtained from the US Nuclear Regulatory Commission Public Document Room files (see Docket No. listed on each certificate) at 1717 H Street, Washington, DC 20555. Note the general license of 10 CFR 71.12 does not authorize the receipt, possession, use or transfer of byproduct source, or special nuclear material; such authorization must be obtained pursuant to 10 CFR Parts 30 to 36, 40, 50, or 70

Directory of certificates of compliance for radioactive materials packages. Certificates of compliance. Volume 2. Revision 9

International Nuclear Information System (INIS)

1986-10-01

This directory contains a Summary Report of NRC Approved Packages (Volume 1). Certificates of Compliance (Volume 2), and a Summary Report of NRC Approved Quality Assurance Programs for Radioactive Material Packages (Volumes 3). The purpose of this directory is make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure them that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program. Copies of the current approval may be obtained from the US Nuclear Regulatory Commission Public Document Room files (see Docket No. listed on each certificate) at 1717 H Street, Washington, DC 20555. Note that the general license of 10 CFR 71.12 does not authorize the receipt, possession, use or transfer of byproduct source, or special nuclear material; such authorization must be obtained pursuant to 10 CFR 30 to 36, 40, 50, or 70

Measuring privacy compliance using fitness metrics

NARCIS (Netherlands)

Banescu, S.; Petkovic, M.; Zannone, N.; Barros, A.; Gal, A.; Kindler, E.

2012-01-01

Nowadays, repurposing of personal data is a major privacy issue. Detection of data repurposing requires posteriori mechanisms able to determine how data have been processed. However, current a posteriori solutions for privacy compliance are often manual, leading infringements to remain undetected.

76 FR 1477 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change Relating...

Science.gov (United States)

2011-01-10

... relating to distribution, compliance of sales and marketing materials, and certain regulatory compliance... Futures Contracts targeting a long notional exposure equivalent to approximately +200% of a Fund's... Leveraged Fund will sell a sufficient number of Short Index Futures Contracts targeting a short notional...

NRC regulatory agenda

International Nuclear Information System (INIS)

1990-01-01

The NRC Regulatory Agenda is a compilation of all rules on which the NRC has proposed or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

Regulatory Safety Issues in the Structural Design Criteria of ASME Section III Subsection NH and for Very High Temperatures for VHTR and GEN IV

International Nuclear Information System (INIS)

O'Donnell, William J.; Griffin, Donald S.

2007-01-01

The objective of this task is to identify issues relevant to ASME Section III, Subsection NH [1], and related Code Cases that must be resolved for licensing purposes for VHTGRs (Very High Temperature Gas Reactor concepts such as those of PBMR, Areva, and GA); and to identify the material models, design criteria, and analysis methods that need to be added to the ASME Code to cover the unresolved safety issues. Subsection NH was originally developed to provide structural design criteria and limits for elevated-temperature design of Liquid Metal Fast Breeder Reactor (LMFBR) systems and some gas-cooled systems. The U.S. Nuclear Regulatory Commission (NRC) and its Advisory Committee for Reactor Safeguards (ACRS) reviewed the design limits and procedures in the process of reviewing the Clinch River Breeder Reactor (CRBR) for a construction permit in the late 1970s and early 1980s, and identified issues that needed resolution. In the years since then, the NRC and various contractors have evaluated the applicability of the ASME Code and Code Cases to high-temperature reactor designs such as the VHTGRs, and identified issues that need to be resolved to provide a regulatory basis for licensing. This Report describes: (1) NRC and ACRS safety concerns raised during the licensing process of CRBR , (2) how some of these issues are addressed by the current Subsection NH of the ASME Code; and (3) the material models, design criteria, and analysis methods that need to be added to the ASME Code and Code Cases to cover unresolved regulatory issues for very high temperature service.

Directory of Certificates of Compliance for radioactive materials packages: Certificates of Compliance. Volume 2, Revision 18

International Nuclear Information System (INIS)

1995-10-01

The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volumes 1 and 2. An alphabetical listing by user name is included in the back of Volume 3 of approved QA programs. The reports include a listing of all users of each package design and approved QA programs prior to the publication date

Directory of Certificates of Compliance for radioactive materials packages: Certificates of Compliance. Volume 2, Revision 18

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-10-01

The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volumes 1 and 2. An alphabetical listing by user name is included in the back of Volume 3 of approved QA programs. The reports include a listing of all users of each package design and approved QA programs prior to the publication date.

Resolution of digital instrumentation and control and human factors technical and regulatory issues for new plants and for modernization of operating plants

International Nuclear Information System (INIS)

Naser, J.A.; Torok, R.C.; Canavan, K.T.

2008-01-01

There are several technical and regulatory issues in the areas of digital I and C, human factors, and control rooms needing generic resolution. If they are not generically resolved, they can contribute to protracted regulatory reviews for operating plant license amendments and substantial delays and increased costs for new plant COL approvals. Therefore; a coordinated, proactive program has been established to resolve key issues. Both Industry and NRC have roles in resolving these key issues and addressing them in future design efforts and regulatory reviews. The Industry initiative is led by the NEI Digital I and C and Human Factors Working Group. NRC has established Task Working Groups under the NRC Digital I and C Steering Committee to address the issues and interact with Industry. EPRI is providing technical input and resolution leadership for some of the issues being addressed in three of the task working groups. For the Highly Integrated Control Room - Human Factors Task area, EPRI has taken the lead in developing draft industry position technical reports for the following three issues: 1) Minimum inventory of human system interfaces, 2) Computerized procedures and associated topics of automation and soft controls, and 3) Methodology to determine the acceptability of manual operator actions response times for a BTP 7-19 software common cause failure. For the Diversity and Defense-in-Depth area, EPRI has taken the lead in developing two draft industry position technical papers on the following topics: 1) Integrating defensive measures and diversity attributes to protect against digital common cause failures and 2) Susceptibility of digital devices and components to common cause failures. For the Risk Informing area, EPRI has taken the lead in developing two draft industry position technical papers on the following topics: 1) Clarifying how to use current methods to model digital systems in a PRA and 2) Application of PRA to specific digital I and C issues

Communication Regulatory Science: Mapping a New Field.

Science.gov (United States)

Noar, Seth M; Cappella, Joseph N; Price, Simani

2017-12-13

Communication regulatory science is an emerging field that uses validated techniques, tools, and models to inform regulatory actions that promote optimal communication outcomes and benefit the public. In the opening article to this special issue on communication and tobacco regulatory science, we 1) describe Food and Drug Administration (FDA) regulation of tobacco products in the US; 2) introduce communication regulatory science and provide examples in the tobacco regulatory science realm; and 3) describe the special issue process and final set of articles. Communication research on tobacco regulatory science is a burgeoning area of inquiry, and this work advances communication science, informs and potentially guides the FDA, and may help to withstand legal challenges brought by the tobacco industry. This research has the potential to have a major impact on the tobacco epidemic and population health by helping implement the most effective communications to prevent tobacco initiation and increase cessation. This special issue provides an example of 10 studies that exemplify tobacco regulatory science and demonstrate how the health communication field can affect regulation and benefit public health.

10 CFR 820.41 - Compliance order.

Science.gov (United States)

2010-01-01

.... The Secretary may issue to any person involved in a DOE nuclear activity a Compliance Order that: (a) Identifies a situation that violates, potentially violates, or otherwise is inconsistent with the Act, a...) States the reasons for the remedy or other action. ...

The regulatory control of radioactive sources in Argentina

International Nuclear Information System (INIS)

Rojkind, R.H.

1998-01-01

Argentina has been conducting nuclear activities for more than forty years, and had established a Regulatory Authority as early as in 1956. Procedures for compliance monitoring and enforcement have been in use in the regulatory control of radioactive sources, and regulatory standards and regulations were in force in Argentina before the accident in Goiania. The conclusions drawn from the Goiania accident encouraged the Argentine authorities to improve some regulatory procedures and helped to enhance the quality of the regulatory process. As a result, the effectiveness of the control of spent radioactive sources has gradually increased, and enforcement actions to prevent radioactive sources ending up in the public domain have improved. Lessons learned in Argentina from the accident in Goiania are presented as well as the main characteristics of an effective enforcement programme to prevent radiological accidents when radioactive sources are used for industrial, medical, research and teaching purposes. (author)

76 FR 64154 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate...

Science.gov (United States)

2011-10-17

... furtherance of the Exchange's outsourcing of its surveillance and other regulatory functions to FINRA pursuant... the October 17, 2011 deadline. See e.g., http://www.finra.org/Industry/Compliance/MarketTransparency... 7420 through 7460 will be construed as NYSE Rules 7420 through 7460 for compliance purposes. As such...

Domestic Compliance with International Environmental Agreements: A Review of Current Literature

OpenAIRE

Roginko, A.

1994-01-01

This essay is an attempt to review the main determinants of compliance with international environmental commitments at the domestic level, with special attention to: 1) the mechanisms by which states determine whether or not to comply, and the roles actors, other than governments, play in these issues, and 2) regime rules and factors exogenous to the regime that affect variation in compliance, with implications for mechanisms by which compliance can be improved.

Future nuclear regulatory challenges

International Nuclear Information System (INIS)

Royen, J.

1998-01-01

In December 1996, the NEA Committee on Nuclear Regulatory Activities concluded that changes resulting from economic deregulation and other recent developments affecting nuclear power programmes have consequences both for licensees and regulatory authorities. A number of potential problems and issues which will present a challenge to nuclear regulatory bodies over the next ten years have been identified in a report just released. (author)

Technical findings and regulatory analysis for Generic Safety Issue II.E.4.3, ''Containment Integrity Check''

International Nuclear Information System (INIS)

Serkiz, A.W.

1988-04-01

This report contains the technical findings and regulatory analysis for Generic Safety Issue II.E.4.3, ''Containment Integrity Check.'' An evaluation of the containment isolation history from 1965 to 1983 reveals that (except for a small number of events) containment integrity has been maintained and that the majority of reported events have been events related to exceeding Technical Specification limits (or 0.6 of the allowable leakage level). In addition, more recent risk analyses have shown that allowable leakage rates even if increased by a factor of 10 would not significantly increase risk. Potential methods of continuous monitoring are identified and evaluated. Therefore, these technical findings and risk evaluations support closure of Generic Safety Issue II.E.4.3

POLYCHLORINATED BIPHENYL COMPLIANCE ISSUES IN THE 21ST CENTURY: POORLY RECOGNIZED AND POTENTIALLY DEVASTATING-8162

International Nuclear Information System (INIS)

Lowry, N

2007-01-01

projects, particularly for nuclear facilities. Depending upon the waste form and the intended disposal path, PCBs can be regulated at thresholds in the low parts-per-billion (ppb). These low regulatory thresholds often are overlooked due to the erroneous belief by many waste management professionals that materials containing PCBs are regulated by TSCA only if their PCB concentration is at least 50 parts-per-million (ppm). Failure to recognize when and how the lower thresholds apply can lead to rejection of the waste materials by treatment, storage and disposal (TSD) facilities as well as potential regulatory non-compliance. Furthermore, re-use of ''excess'' materials with PCBs is also regulated by TSCA. In the event of a characterization error, the costs required to make necessary corrections can be very high. This paper will focus on PCB characterization and waste management issues associated with D and D of DOE nuclear facilities. It will identify PCB materials that are likely to be present in such facilities, with emphasis on the nonliquid PCB forms. The paper will discuss characterization pitfalls associated with Non-Liquid PCBs (NLPCBs), including circumstances in which NLPCBs can migrate into other materials. The paper also will identify TSCA requirements for materials with very low concentrations of PCBs; certain materials are regulated at concentrations as low as 0.5 (micro)g/L PCBs (approximately 0.5 ppb). The paper will then examine the potentially extensive impacts to a facility if the materials are not managed in a TSCA-compliant manner. Examples from a recent D and D project at the DOE Savannah River Site will be used to illustrate key points and lessons learned. It is expected that this information would be useful to other DOE sites, DoD installations and commercial nuclear facilities constructed prior to 1979

NRC regulatory agenda

International Nuclear Information System (INIS)

1991-04-01

The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

NRC Regulatory Agenda

International Nuclear Information System (INIS)

1991-08-01

The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and all petitions for rulemaking which have been received by the commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

75 FR 9201 - DCP Raptor Pipeline, LLC; Notice of Compliance Filing

Science.gov (United States)

2010-03-01

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR09-32-002] DCP Raptor... Raptor Pipeline, LLC (Raptor) filed its Statement of Operating Conditions in compliance with the January 27, 2010 Letter Order (January 27th Letter Order) in Docket Nos. PR09-32-000 and PR09-32-001. Raptor...

The role of trust in nurturing compliance: a study of accused tax avoiders.

Science.gov (United States)

Murphy, Kristina

2004-04-01

Why an institution's rules and regulations are obeyed or disobeyed is an important question for regulatory agencies. This paper discusses the findings of an empirical study that shows that the use of threat and legal coercion as a regulatory tool--in addition to being more expensive to implement--can sometimes be ineffective in gaining compliance. Using survey data collected from 2,292 taxpayers accused of tax avoidance, it will be demonstrated that variables such as trust need to be considered when managing noncompliance. If regulators are seen to be acting fairly, people will trust the motives of that authority, and will defer to their decisions voluntarily. This paper therefore argues that to shape desired behavior, regulators will need to move beyond motivation linked purely to deterrence. Strategies directed at reducing levels of distrust between the two sides may prove particularly effective in gaining voluntary compliance with an organization's rules and regulations.

Regulatory analysis for the resolution of Generic Issue 125.II.7 ''Reevaluate Provision to Automatically Isolate Feedwater from Steam Generator During a Line Break''

International Nuclear Information System (INIS)

Basdekas, D.L.

1988-09-01

Generic Issue 125.II.7 addresses the concern related to the automatic isolation of auxiliary feedwater (AFW) to a steam generator with a broken steam or feedwater line. This regulatory analysis provides a quantitative assessment of the costs and benefits associated with the removal of the AFW automatic isolation and concludes that no new regulatory requirements are warranted. 21 refs., 7 tabs

Regulatory aspects of radiation protection in Indian nuclear plants

International Nuclear Information System (INIS)

Chander, Vipin; Pawar, S.K.; Duraisamy, S.

2012-01-01

Atomic Energy Act of 1962 covers the radiation safety aspects in the development, control and use of atomic energy. To carry out certain regulatory and safety functions under this act, Atomic Energy Regulatory Board (AERB) was constituted in November 15, 1983. Operating Nuclear Power Plants (NPPs) account for about 60% of occupational collective dose and about 65% of the number of radiation workers in the nuclear fuel cycle facilities. Therefore radiation protection aspects in NPPs are of prime importance. In 1970s and 1980s the high radiation exposures in NPPs was an issue with TAPS-1 and 2 reaching annual collective dose of 50 Person-Sv. In response to this, AERB constituted an expert committee to investigate the possibility of reducing collective doses in NPPs in 1988. Subsequently the recommendations of this committee were implemented in all NPPs. In 1990, International Commission on Radiological Protection (ICRP) recommended a downward revision of occupational dose limit to 20 mSv/yr from the earlier limit of 50 mSv/yr. Regulatory body endorsed these recommendations and gradually brought down the annual dose limits from 40 mSv in 1991 to 30 mSv in 1994 with the limit of 100 mSv averaged over a five year period in line with ICRP recommendations. Over the years, the regulatory body has put in place a sound regulatory frame work and mechanism to ensure adequate protection of occupational workers, members of public and environment due to operation of NPPs. Vast experiences in the field of radiation protection vis-à-vis stringent regulatory requirements such as review of exposure cases and special regulatory inspections during Biennial Shut Down (BSD) has helped in downward trends in occupational and public doses. This paper highlights the role of regulatory body in controlling the radiation doses to both occupational workers and members of public in the NPPs through a three-tier review system. The regulatory oversight, inspections and reviews has resulted in

Environmental audits: Tax, accounting and disclosure issues

International Nuclear Information System (INIS)

MacKnight, R.

1991-01-01

An overview is presented of the financial and legal issues associated with environmental audits, with an emphasis on tax issues. Accelerated depreciation write-offs are provided for qualified pollution control equipment, and may also qualify for tax credits. The Accounting Standards Committee recommends that provision should be made for future removal and site restoration costs and net of expected recoveries, in a rational and systematic manner by charges to income. Under the Federal Income Tax Act (ITA), future reclamation and shutdown costs will only be deductible if they pass three hurdles: a liability which requires the expenditure of funds in the future may not necessarily be an expense; if the liability can be viewed as an expense, is it incurred for the purpose of gaining or producing income; and is a deduction prohibited because it is on account of capital. A proposed solution to these problems is to adopt the US model that allows the deduction of estimated costs of reclaiming land that is disturbed during the current year at mines and waste disposal sites. Tax treatment of compliance costs, securities law disclosure, proposed federal government policies, proposed regulatory measures, and proposed fiscal measures are discussed

NRC Regulatory Agenda

International Nuclear Information System (INIS)

1991-10-01

The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

NRC regulatory agenda

International Nuclear Information System (INIS)

1993-04-01

The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

Removal of regulatory controls for materials and sites

International Nuclear Information System (INIS)

2004-01-01

Issues with the removal of regulatory controls are very important on the agenda of the regulatory authorities dealing with radioactive waste management (RWM). These issues arise prominently in decommissioning and in site remediation, and decisions can be very wide ranging having potentially important economic impacts and reaching outside the RWM area. The RWMC Regulators Forum started to address these issues by holding a topical discussion at its meeting in March 2003. Ths present document collates the national regulatory positions in the area of removal of regulatory controls. A summary of the national positions is also provided. The document is up to date to April 2004. (authors)

Regulatory analysis for the resolution of Generic Issue 115, enhancement of the reliability of the Westinghouse Solid State Protection System

International Nuclear Information System (INIS)

Basdekas, D.L.

1989-05-01

Generic Issue 115 addresses a concern related to the reliability of the Westinghouse reactor protection system for plants using the Westinghouse Solid State Protection System (SSPS). Several options for improving the reliability of the Westinghouse reactor trip function for these plants and their effect on core damage frequency (CDF) and overall risk were evaluated. This regulatory analysis includes a quantitative assessment of the costs and benefits associated with the various options for enhancing the reliability of the Westinghouse SSPS and provides insights for consideration and industry initiatives. No new regulatory requirements are proposed. 25 refs., 11 tabs

Audit of the Federal Energy Regulatory Commission`s Office of Chief Accountant

Energy Technology Data Exchange (ETDEWEB)

NONE

1995-04-07

The Federal Energy Regulatory Commission`s (Commission) mission is to oversee America`s natural gas and oil pipeline transportation, electric utility, and hydroelectric power industries to ensure that consumers receive adequate energy supplies at just and reasonable rates. To carry out this mission, the Commission issues regulations covering the accounting, reporting, and rate-making requirements of the regulated utility companies. The Commission`s Office of Chief Accountant performs financial related audits at companies to ensure compliance with these regulations. The purpose of this audit was to evaluate the office of Chief Accountant`s audit performance. Specifically, the objectives were to determine if the most appropriate audit approach was used and if a quality assurance process was in place to ensure reports were accurate and supported by the working papers.

Environmental implementation plan: Chapter 14, Environmental compliance tracking and data management

International Nuclear Information System (INIS)

Story, C.H.

1993-01-01

Environmental projects, issues, and programs have become increasingly important to the Westinghouse Savannah River Company (WSRC) management and the Department of Energy (DOE). A compliance-tracking system has been developed to monitor environmental requirements and commitments because they have become increasingly complex and numerous. An Environmental Data Management (EDM) steering committee was formed in October 1987 to develop computer system solutions to environmental needs. The committee's main objective is to coordinate, within SRS divisions, the separate efforts that have been or are being developed to meet regulatory requirements and specific programmatic goals. The Environmental and Graphical Information Systems (E ampersand GIS) Program was recently developed to establish a more formal organizational structure and enhance the coordination of geographical information systems (GIS) and environmental data management (EDM) activities at SRS. The general strategy of the program is to establish a coordination focal point for GIS and EDM activities, to provide for the integration of the several environmental and graphical information systems which exist mostly in stand-alone arrangements, and to guide the development of data management and geographical information applications in order to achieve alignment with Site computing architecture and standards. The E ampersand GIS Program will enhance the Site's ability to respond to data requirements in support of new missions, changing directives, and increasing regulatory requirements

Compliance of feed limits, does not mean compliance of food limits

Directory of Open Access Journals (Sweden)

van Raamsdonk LWD.

2009-01-01

Full Text Available The carry-over of contaminants from feed to animal food products is an important aspect of the animal production chain. For a proper containment, limits for feed as well food products are fixed for a series of chemicals, e.g. dioxins and dioxin-like PCBs, lead, cadmium, some chlorinated pesticides, and aflatoxin B1 (and its metabolite M1 in milk. The relationship between feed and food limits is an important issue. An ideal goal is to assure that compliance to a feed limits automatically results in compliance to food limits. In order to collect information about this relationship, several simulation models and a large database on transfer factors have been developed. An optimal choice between either a model or an application of data from the Transfer Database is based on both the knowledge level, and on the circumstances of the specific situation. To reach and validate such an optimal choice an Expert System Carry-Over is currently in development, containing four different modules: 1 the different calculation models and the Transfer Database, 2 a decision tree for choosing the optimal strategy, 3 data tables indicating knowledge levels of compound/animal/product parameters, and 4 supporting databases containing information on consumption and composition of daily diets, animal parameters, and amounts of (daily production. Calculations indicate that for dioxins compliance to feed levels does not necessarily mean that food limits are complied as well. Besides an estimation of the compliance to limits, the expert system is a tool for feed related risk assessments, and for planning of future research.

Review of Legislation and Regulatory Framework in Ukraine with Regard to Environmental Radiation Monitoring

International Nuclear Information System (INIS)

Goldammer, Wolfgang; Batandjieva, Borislava; Nasvit, Oleg; German, Olga

2009-06-01

The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation

Review of Legislation and Regulatory Framework in Ukraine with Regard to Environmental Radiation Monitoring

Energy Technology Data Exchange (ETDEWEB)

Goldammer, Wolfgang; Batandjieva, Borislava (Private Consultants (Ukraine)); Nasvit, Oleg (National Security and Defence Council of Ukraine, Kyiv (Ukraine)); German, Olga (Swedish Radiation Safety Authority, Stockholm (Sweden))

2009-06-15

The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation

The regulatory control of radioactive sources in Argentina

Energy Technology Data Exchange (ETDEWEB)

Rojkind, Roberto Hector [Autoridade Regulatoria Nuclear, Buenos Aires (Argentina)

1997-12-31

Argentina has been conducting nuclear activities for more than forty years, and as early as in 1956 established a Regulatory Authority. Procedures for compliance monitoring and enforcement have been in use in the regulatory control of radioactive sources, and regulatory standards and regulations had been set in Argentina, before the accident in Goiania. The conclusions drawn from that accident encouraged in Argentina the improvement of some regulatory procedures and helped to enhance the quality of the regulatory process. Therefore, the effectiveness of the control of spent radioactive sources has gradually increased, and enforcement actions to prevent radioactive sources ending up in the public domain improved. Some lessons learned in Argentina from the accident in Goiania and the main characteristics of an effective enforcement program helpful to prevent radiological accidents in industrial, medical, research and teaching uses of radioactive sources are presented. (author) 9 refs; e-mail: rrojkind at sede.arn.gov.br

Estimates and implications of the costs of compliance with biosafety regulations in developing countries.

Science.gov (United States)

Falck-Zepeda, Jose; Yorobe, Jose; Husin, Bahagiawati Amir; Manalo, Abraham; Lokollo, Erna; Ramon, Godfrey; Zambrano, Patricia; Sutrisno

2012-01-01

Estimating the cost of compliance with biosafety regulations is important as it helps developers focus their investments in producer development. We provide estimates for the cost of compliance for a set of technologies in Indonesia, the Philippines and other countries. These costs vary from US $100,000 to 1.7 million. These are estimates of regulatory costs and do not include product development or deployment costs. Cost estimates need to be compared with potential gains when the technology is introduced in these countries and the gains in knowledge accumulate during the biosafety assessment process. Although the cost of compliance is important, time delays and uncertainty are even more important and may have an adverse impact on innovations reaching farmers.

Duke Surgery Research Central: an open-source Web application for the improvement of compliance with research regulation.

Science.gov (United States)

Pietrobon, Ricardo; Shah, Anand; Kuo, Paul; Harker, Matthew; McCready, Mariana; Butler, Christeen; Martins, Henrique; Moorman, C T; Jacobs, Danny O

2006-07-27

Although regulatory compliance in academic research is enforced by law to ensure high quality and safety to participants, its implementation is frequently hindered by cost and logistical barriers. In order to decrease these barriers, we have developed a Web-based application, Duke Surgery Research Central (DSRC), to monitor and streamline the regulatory research process. The main objective of DSRC is to streamline regulatory research processes. The application was built using a combination of paper prototyping for system requirements and Java as the primary language for the application, in conjunction with the Model-View-Controller design model. The researcher interface was designed for simplicity so that it could be used by individuals with different computer literacy levels. Analogously, the administrator interface was designed with functionality as its primary goal. DSRC facilitates the exchange of regulatory documents between researchers and research administrators, allowing for tasks to be tracked and documents to be stored in a Web environment accessible from an Intranet. Usability was evaluated using formal usability tests and field observations. Formal usability results demonstrated that DSRC presented good speed, was easy to learn and use, had a functionality that was easily understandable, and a navigation that was intuitive. Additional features implemented upon request by initial users included: extensive variable categorization (in contrast with data capture using free text), searching capabilities to improve how research administrators could search an extensive number of researcher names, warning messages before critical tasks were performed (such as deleting a task), and confirmatory e-mails for critical tasks (such as completing a regulatory task). The current version of DSRC was shown to have excellent overall usability properties in handling research regulatory issues. It is hoped that its release as an open-source application will promote improved

Duke Surgery Research Central: an open-source Web application for the improvement of compliance with research regulation

Directory of Open Access Journals (Sweden)

Martins Henrique

2006-07-01

Full Text Available Abstract Background Although regulatory compliance in academic research is enforced by law to ensure high quality and safety to participants, its implementation is frequently hindered by cost and logistical barriers. In order to decrease these barriers, we have developed a Web-based application, Duke Surgery Research Central (DSRC, to monitor and streamline the regulatory research process. Results The main objective of DSRC is to streamline regulatory research processes. The application was built using a combination of paper prototyping for system requirements and Java as the primary language for the application, in conjunction with the Model-View-Controller design model. The researcher interface was designed for simplicity so that it could be used by individuals with different computer literacy levels. Analogously, the administrator interface was designed with functionality as its primary goal. DSRC facilitates the exchange of regulatory documents between researchers and research administrators, allowing for tasks to be tracked and documents to be stored in a Web environment accessible from an Intranet. Usability was evaluated using formal usability tests and field observations. Formal usability results demonstrated that DSRC presented good speed, was easy to learn and use, had a functionality that was easily understandable, and a navigation that was intuitive. Additional features implemented upon request by initial users included: extensive variable categorization (in contrast with data capture using free text, searching capabilities to improve how research administrators could search an extensive number of researcher names, warning messages before critical tasks were performed (such as deleting a task, and confirmatory e-mails for critical tasks (such as completing a regulatory task. Conclusion The current version of DSRC was shown to have excellent overall usability properties in handling research regulatory issues. It is hoped that its

Directory of Certificates of Compliance for Radioactive Materials Packages. Certificates of Compliance. Volume 2, Revision 8

International Nuclear Information System (INIS)

1985-10-01

This directory contains a Summary Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Summary Report of NRC Approved Quality Assurance Programs for Radioactive Material Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance number is included at the back of each volume of the directory. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR 173.471 and 10 CFR Part 71, as applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure them that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program. Copies of the current approval may be obtained from the US Nuclear Regulatory Commission Public Document Room files (see Docket No. listed on each certificate) at 1717 H Street, Washington, DC 20555. Note that the general license of 10 CFR 71.12 does not authorize the receipt, possession, use or transfer of byproduct source, or special nuclear material; such authorization must be obtained pursuant to 10 CFR Parts 30 to 36, 40, 50, or 70

Inaccessible Built Environments in Ghana’s Universities: The Bane of a Weak Legal and Regulatory Framework for Persons with Disabilities 1

Directory of Open Access Journals (Sweden)

John Tiah Bugri

2017-05-01

Full Text Available This is a qualitative study of the role of the legal and regulatory framework in making built environments accessible to Persons with Disabilities in six universities in Ghana. It revealed that the local component of legislation dealing with accessible environments was fragile and fraught with compliance challenges, administrative laxity and the lack of a time conscious approach to issues thereby resulting in inaccessible built environments. In effect, the study gives credence to the proposition of the social model that disability is a creation of humankind and recommends an amendment of Ghana’s Persons with Disability Act.

Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations.

Science.gov (United States)

Gelinas, Luke; Pierce, Robin; Winkler, Sabune; Cohen, I Glenn; Lynch, Holly Fernandez; Bierer, Barbara E

2017-03-01

The use of social media as a recruitment tool for research with humans is increasing, and likely to continue to grow. Despite this, to date there has been no specific regulatory guidance and there has been little in the bioethics literature to guide investigators and institutional review boards (IRBs) faced with navigating the ethical issues such use raises. We begin to fill this gap by first defending a nonexceptionalist methodology for assessing social media recruitment; second, examining respect for privacy and investigator transparency as key norms governing social media recruitment; and, finally, analyzing three relatively novel aspects of social media recruitment: (i) the ethical significance of compliance with website "terms of use"; (ii) the ethics of recruiting from the online networks of research participants; and (iii) the ethical implications of online communication from and between participants. Two checklists aimed at guiding investigators and IRBs through the ethical issues are included as appendices.

MGR COMPLIANCE PROGRAM GUIDANCE PACKAGE FOR RADIATION PROTECTION EQUIPMENT, INSTRUMENTATION, AND FACILITIES

International Nuclear Information System (INIS)

2000-01-01

This Compliance Program Guidance Package identifies the regulatory guidance and industry codes and standards addressing radiation protection equipment, instrumentation, and support facilities considered to be appropriate for radiation protection at the Monitored Geologic Repository (MGR). Included are considerations relevant to radiation monitoring instruments, calibration, contamination control and decontamination, respiratory protection equipment, and general radiation protection facilities. The scope of this Guidance Package does not include design guidance relevant to criticality monitoring, area radiation monitoring, effluent monitoring, and airborne radioactivity monitoring systems since they are considered to be the topics of specific design and construction requirements (i.e., ''fixed'' or ''built-in'' systems). This Guidance Package does not address radiation protection design issues; it addresses the selection and calibration of radiation monitoring instrumentation to the extent that the guidance is relevant to the operational radiation protection program. Radon and radon progeny monitoring instrumentation is not included in the Guidance Package since such naturally occurring radioactive materials do not fall within the NRC's jurisdiction at the MGR

Print Me an Organ? Ethical and Regulatory Issues Emerging from 3D Bioprinting in Medicine.

Science.gov (United States)

Gilbert, Frederic; O'Connell, Cathal D; Mladenovska, Tajanka; Dodds, Susan

2018-02-01

Recent developments of three-dimensional printing of biomaterials (3D bioprinting) in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article (1) considers whether there is a limit as to what should be bioprinted in medicine; (2) examines key risks of significant harm associated with testing 3D bioprinting for humans; (3) investigates the clinical trial paradigm used to test 3D bioprinting; (4) analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; (5) explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments.

TRUPACT-II, a regulatory perspective

International Nuclear Information System (INIS)

Gregory, P.C.; Spooner, O.R.

1995-01-01

The Transuranic Package Transporter II (TRUPACT-II) is a US Nuclear Regulatory Commission (NRC) certified Type B packaging for the shipment of contact-handled transuranic (CH-TRU) material by the US Department of Energy (DOE). The NRC approved the TRUPACT-II design as meeting the requirements of Title 10, Code of Federal Regulations, Part 71 (10 CFR 71) and issued Certificate of Compliance (CofC) Number 9218 to the DOE. There are currently 15 certified TRUPACT-IIs. Additional TRUPACT-IIs will be required to make more than 15,000 shipments of CH-TRU waste to the Waste Isolation Pilot Plant (WIPP) site near Carlsbad, New Mexico. The TRUPACT-II may also be used for the DOE inter-site and intra-site shipments of CH-TRU waste. The Land Withdrawal Act (Public Law 102-579), enacted by the US Congress, October 30, 1992, and an agreement between the DOE and the State of New Mexico, signed August 4, 1987, both stipulate that only NRC approved packaging may be used for shipments of TRU waste to the WIPP. Early in the TRUPACT-II development phase it was decided that the transportation system (tractor, trailer, and TRUPACT-II) should be highway legal on all routes without the need for oversize and/or overweight permits. In large measure, public acceptance of the DOE's efforts to safely transport CH-TRU waste depends on the public's perception that the TRUPACT-II is in compliance with all applicable regulations, standards, and quality assurance requirements. This paper addresses some of the numerous regulations applicable to Type B packaging, and it describes how the TRUPACT-II complies with these regulations

FORUM ISSUES IN THE ENFORCEMENT OF REGULATORY ...

African Journals Online (AJOL)

in his role as father of the country. In modern times, the ... of self-regulatory organisations in most financial markets who thus far have ..... companies and their officers under the Act? There are as yet no clear an- swers to ..... 578 (High Court of Singapore) where Chief Justice Yong Pung How held that to establish a breach of ...

Incentive mechanisms as a strategic option for acid rain compliance

International Nuclear Information System (INIS)

South, D.W.; Bailey, K.A.; McDermott, K.A.

1991-01-01

Title IV of the Clean Air Act Amendments (CAAA) of 1990 (P.L. 101--549) establishes the use of flexible emission compliance strategies for electric utilities to reduce the emissions of add precursors (SO 2 , NO 2 ). To control SO 2 emissions, tradeable emission allowances will be used; NO 2 emissions will be controlled by an emission standard, but a utility is permitted to average NO 2 emissions systemwide to meet the standard. Both of these policies promote flexibility and cost savings for the utility while achieving the prescribed emission reduction goals of P.L. 101--549. The use of SO 2 emission allowances has two notable benefits: A utility has the choice of a wide range of compliance methods allowing it to minimize compliance costs and second; the use of transferable emission allowances promote technological innovation with respect to emissions reduction/control. This report discusses the use of regulatory incentives towards the achievement of a Title IV goal of cost reduction of SO 2 emissions

77 FR 32159 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Filing and Immediate...

Science.gov (United States)

2012-05-31

... the proposed rule change is available on the Exchange's Web site ( http://www.c2exchange.com/Legal... responsibilities. To more accurately reflect the current regulatory and compliance functions of the Regulatory... market and a national market system, and, in general, to protect investors and the public interest. The...

Directory of Certificates of Compliance for Radioactive Materials Packages: Report of NRC approved packages

International Nuclear Information System (INIS)

1988-12-01

This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), all Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective October 1, 1988. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

Directory of certificates of compliance for radioactive materials packages, Report of NRC approved packages

International Nuclear Information System (INIS)

1990-10-01

This directory contains a Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Materials Packages effective October 1, 1990. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volume 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by Company name is included in the back of Volume 3 for approved QA programs. The Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

Data Science and Political Economy: Application to Financial Regulatory Structure

Directory of Open Access Journals (Sweden)

Sharyn O'Halloran

2016-11-01

Full Text Available The development of computational data science techniques in natural language processing and machine learning algorithms to analyze large and complex textual information opens new avenues for studying the interaction between economics and politics. We apply these techniques to analyze the design of financial regulatory structure in the United States since 1950. The analysis focuses on the delegation of discretionary authority to regulatory agencies in promulgating, implementing, and enforcing financial sector laws and overseeing compliance with them. Combining traditional studies with the new machine learning approaches enables us to go beyond the limitations of both methods and offer a more precise interpretation of the determinants of financial regulatory structure.

Regulatory issues associated with closure of the Hanford AX Tank Farm ancillary equipment

International Nuclear Information System (INIS)

Becker, D.L.

1998-01-01

Liquid mixed, high-level radioactive waste has been stored in underground single-shell tanks at the US Department of Energy's (DOE's) Hanford Site. After retrieval of the waste from the single-shell tanks, the DOE will proceed with closure of the tank farm. The 241-AX Tank Farm includes four one-million gallon single-shell tanks in addition to sluice lines, transfer lines, ventilation headers, risers, pits, cribs, catch tanks, buildings, well and associated buried piping. This equipment is classified as ancillary equipment. This document addresses the requirements for regulatory close of the ancillary equipment in the Hanford Site 241-AX Tank Farm. The options identified for physical closure of the ancillary equipment include disposal in place, disposal in place after treatment, excavation and disposal on site in an empty single-shell tank, and excavation and disposal outside the AX Tank Farm. The document addresses the background of the Hanford Site and ancillary equipment in the AX Tank Farm, regulations for decontamination and decommissioning of radioactively contaminated equipment, requirements for the cleanup and disposal of radioactive wastes, cleanup and disposal requirements governing hazardous and mixed waste, and regulatory requirements and issues associated with each of the four physical closure options. This investigation was conducted by the Sandia National Laboratories, Albuquerque, New Mexico, during Fiscal Year 1998 for the Hanford Tanks Initiative Project

Selected issues relating to target companies and their boards in the context of merger and acquisition transactions

International Nuclear Information System (INIS)

Allen, F.R.

1998-01-01

Some of the practical, legal and regulatory issues which the board of directors of a target company should bear in mind in their deliberations concerning a take-over bid are reviewed. Directors of such companies will require compliance with and adherence to standard legal and regulatory rules of conduct. Developing a team to deal with the myriad details of a take-over, acquisition or merger, preparing and compiling and maintaining a manual of relevant information are highly recommended. Fiduciary duties of directors and its relevance to mergers and acquisitions are illustrated by reference to a number of recent actual court cases involving these issues. Relevant Canadian and U.S. Case Law is reviewed. It is emphasized throughout the paper that take-over transactions, mergers and acquisitions are complex and time consuming processes. It is essential and customary for senior management to be active participants in most merger and acquisition matters to provide the strategic input which drives the efforts of all involved. Equally important is to establish appropriate governance practices and to prepare and equip the corporation's mergers and acquisitions team in advance, should such events arise on short notice by design or otherwise. 38 refs

Regulatory and licensee surveys

International Nuclear Information System (INIS)

2009-01-01

Prior to the workshop two CSNI/WGHOF surveys were distributed. One survey was directed at regulatory bodies and the other was directed at plant licensees. The surveys were: 1 - Regulatory Expectations of Licensees' Arrangements to Ensure Suitable Organisational Structure, Resources and Competencies to Manage Safety (sent to WGHOF regulatory members). The survey requested that the respondents provide a brief overview of the situation related to plant organisations in their country, their regulatory expectations and their formal requirements. The survey addressed three subjects: the demonstration and documentation of organisational structures, resources and competencies, organisational changes, issues for improvement (for both current and new plants). Responses were received from eleven regulatory bodies. 2 - Approaches to Justify Organisational Suitability (sent to selected licensees). The purpose of the survey to was to gain an understanding of how licensees ensure organisational suitability, resources and competencies. This information was used to assist in the development of the issues and subjects that were addressed at the group discussion sessions. Responses were received from over fifteen licensees from nine countries. The survey requested that the licensees provide information on how they ensure effective organisational structures at their plants. The survey grouped the questions into the following four categories: organisational safety functions, resource and competence, decision-making and communication, good examples and improvement needs. The findings from these surveys were used in conjunction with other factors to identify the key issues for the workshop discussion sessions. The responses from these two surveys are discussed briefly in Sections 4 and 5 of this report. More extensive reviews of the regulatory and licensee responses are provided in Appendix 1

Regulatory oversight of maintenance activities at nuclear power plants

International Nuclear Information System (INIS)

Pape, M.

1997-01-01

Regulation of nuclear safety in the UK is based on monitoring of compliance with licence conditions. This paper discusses legislation aspects, license conditions, license requirements for maintenance and maintenance activities in the UK. It also addresses the regulator utility interaction, the regulatory inspection of maintenance and the trends in maintenance. (author)

Compliance issues raised by the United States' ratification and implementation of the education articles of the Convention on the Rights of the Child.

Science.gov (United States)

Adams, Christopher; Rubel, Jordana

2010-01-01

This article evaluates compliance issues the United States could face in ratifying the education provisions of the United Nations Convention on the Rights of the Child (CRC). The authors compare states parties' obligations under the education provisions of the CRC--as construed by the CRC committee--with federal and state education protections and programs in the United States. The authors conclude that the United States currently complies with most of the provisions and faces minimal risk in ratifying the remaining provisions.

The elderly on dialysis: some considerations in compliance.

Science.gov (United States)

McKevitt, P M; Jones, J F; Lane, D A; Marion, R R

1990-10-01

Compliance with scheduled treatments, dietary and fluid restrictions, and multiple medications is an important component in the care and well-being of end-stage renal disease (ESRD) patients. Given the rigorus and complex demands of dialysis, it is important to examine the issue of compliance, focusing on a large and ever-increasing segment of our patient population, the elderly. The ESRD literature reflects efforts to define and measure levels of compliance, identify factors that influence and predict compliance, and develop intervention strategies to improve adherence to treatment regimens. While limited attention has been focused specifically on the elderly, there are studies suggesting that age may be a factor associated with improved adherence and that social support may be a significant contributor to compliance in this patient group. In an effort to examine the current status and needs of the dialysis elderly, research is in progress at Chromalloy American Kidney Center, Washington University, which replicates a study of 5 years ago. Eighty-four patients age 60 and over, on dialysis for a minimum of 6 months, were identified. Sociodemographic, treatment, compliance, and functional capacity data were collected; additional mental and psychological testing was completed on patients willing and able to participate. Preliminary data suggest the current elderly population is larger and significantly older than that of 5 years ago. Other sociodemographic data indicate the population is increasingly female, black, and more socioeconomically disadvantaged. In regard to compliance, the vast majority of elderly demonstrate good compliance as measured by serum potassium, fair to good compliance with phosphorus, and fair to poor compliance with fluid restrictions.(ABSTRACT TRUNCATED AT 250 WORDS)

Low-income minority fathers' control strategies and children's regulatory skills

Science.gov (United States)

Malin, Jenessa L.; Cabrera, Natasha J.; Karberg, Elizabeth; Aldoney, Daniela; Rowe, Meredith

2015-01-01

The current study explored the bidirectional association of children's individual characteristics, fathers' control strategies at 24-months and children's regulatory skills at pre-kindergarten (pre-K). Using a sample of low-income minority families with 2-year-olds from the Early Head Start Evaluation Research Program (n = 71) we assessed the association between child gender and vocabulary skills, fathers' control strategies at 24-months (e.g., regulatory behavior and regulatory language), and children's sustained attention and emotion regulation at pre-kindergarten. There were three main findings. First, fathers' overwhelmingly use commands (e.g., do that) to promote compliance in their 24-month old children. Second, children's vocabulary skills predict fathers' regulatory behaviors during a father-child interaction, whereas children's gender predicts fathers' regulatory language during an interaction. Third, controlling for maternal supportiveness, fathers' regulatory behaviors at 24-months predict children's sustained attention at pre-kindergarten whereas fathers' regulatory language at 24-months predicts children's emotion regulation at pre-kindergarten. Our findings highlight the importance of examining paternal contributions to children's regulatory skills. PMID:25798496

Title IV compliance strategies and the incidence of co-pollutants and synergistic pollution controls

International Nuclear Information System (INIS)

South, D.W.; Bailey, K.A.

1993-01-01

Title 4 of the Clean Air Act Amendments (CAAA) of 1990 (Pub.L. 101-549) authorizes a system of tradeable SO 2 allowances in order to reduce Utility SO 2 emissions in a cost-effective manner. The CAAA also expanded and strengthened regulation of urban ozone nonattainment (Title 1), air toxics (Title 3) and utility NO x emissions (Title 4). Implementation of the requirements of each of these titles will force the utility industry to incur additional control expenditures. Utilities also face the potential for regulation of CO 2 emissions within the next decade, and increased regulation and reclassification of high volume combustion wastes, i.e., scrubber sludge, fly ash and bottom ash. Unfortunately for the utility industry, many of the issues in Titles 1, 3, 4 and other regulations have not been resolved, even though utility Phase 1 compliance planning has begun. This paper will examine compliance conflicts and synergies resulting from utility compliance with Title IV SO 2 requirements. The fundamental question addressed is: what multi-media effects are introduced and what opportunities exist through utility compliance with Title 4-SO 2 . Several issues will be addressed including: (1) the potential impact of non-SO 2 regulation on utility compliance and compliance costs, (2) the flexibility of utility SO 2 compliance options, (3) the synergies and co-pollutant effects associated with particular compliance options, (4) the impact of the timing and uncertainty of the various rules on utility compliance choice

Grid connectivity issues and the importance of GCC. [GCC - Grid Code Compliance

Energy Technology Data Exchange (ETDEWEB)

Das, A.; Schwartz, M.-K. [GL Renewable Certification, Malleswaram, Bangalore (India)

2012-07-01

In India, the wind energy is concentrated in rural areas with a very high penetration. In these cases, the wind power has an increasing influence on the power quality on the grids. Another aspect is the influence of weak grids on the operation of wind turbines. Hence it becomes very much essential to introduce such a strong grid code which is particularly applicable to wind sector and suitable for Indian environmental grid conditions. This paper focuses on different international grid codes and their requirement with regard to the connection of wind farms to the electric power systems to mitigate the grid connectivity issues. The requirements include the ways to achieve voltage and frequency stability in the grid-tied wind power system. In this paper, comparative overview and analysis of the main grid connecting requirements will be conducted, comprising several national and regional codes from many countries where high wind penetration levels have been achieved or are expected in the future. The objective of these requirements is to provide wind farms with the control and regulation capabilities encountered in conventional power plants and are necessary for the safe, reliable and economic operation of the power system. This paper also provides a brief idea on the Grid Code Compliance (GCC) certification procedure implemented by the leading accredited certifying body like Germanischer Lloyd Renewables Certification (GL RC), who checks the conformity of the wind turbines as per region specific grid codes. (Author)

Obedience to compliance programs and independence for electricity and natural gas system operators. 2009 report

International Nuclear Information System (INIS)

2009-12-01

In France, system operators belong to groups that also conduct business in the energy sector, in fields governed by competition rules. They could therefore be tempted to use their privileged position to their group's benefit, which would disadvantage end consumers. Non-discriminatory access to electricity and gas transmission and distribution networks is at the core of the market opening to competition approach implemented by the European Union since the end of the 1990's. EU and national enactments in force highlight two tools to ensure nondiscrimination: compliance programmes and independence of system operators with regard to their parent companies. Firstly, compliance programs contain measures taken to ensure that discrimination is completely excluded and that their application is subject to appropriate monitoring. Secondly, system operator independence plays a part in preventing discrimination against competitors with other business activities (generation, supply, etc.) within the same group. In application of these enactments, every electricity or natural gas transmission or distribution system operator serving more than 100,000 customers provided CRE, the Energy Regulatory Commission, with their annual reports on the application of their compliance programs. This document is CRE's 2009 report about compliance programmes and independence of electricity and natural gas system operators. Its content can be summarized as follows: 1 - system operator independence serving consumers: Non-discriminatory access to networks is essential for the development of competitive markets, System operator compliance programs and independence act as a guarantee of nondiscrimination, The legal context in which these issues are addressed is set to change in the near future; 2 - A high level of obedience to compliance programs: The continued efforts of system operators prevent discrimination, CR E has assessed distribution system operators by means of a mystery

Directory of certificates of compliance for radioactive materials packages

International Nuclear Information System (INIS)

1997-10-01

The purpose of this directory is to make available a convenient source of information on packagings approved by the U.S. Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volumes 1 and 2. An alphabetical listing by user name is included in the back of Volume 3 for approved Quality Assurance programs. The reports include a listing of all users of each package design and approved Quality Assurance programs prior to the publication date of the directory. Comments to make future revisions of this directory more useful are invited and should be directed to the Spent Fuel Project Office, U.S. Nuclear Regulatory Commission

Directory of certificates of compliance for radioactive materials packages

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-10-01

The purpose of this directory is to make available a convenient source of information on packagings approved by the U.S. Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the front of Volumes 1 and 2. An alphabetical listing by user name is included in the back of Volume 3 for approved Quality Assurance programs. The reports include a listing of all users of each package design and approved Quality Assurance programs prior to the publication date of the directory. Comments to make future revisions of this directory more useful are invited and should be directed to the Spent Fuel Project Office, U.S. Nuclear Regulatory Commission.

78 FR 54502 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Science.gov (United States)

2013-09-04

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule... Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC'' or ``Commission... or manipulative motivation for the trading activity at issue.\\4\\ Specifically, proposed Supplementary...

Technical assistance for regulatory development: review and evaluation of the EPA standard 40 CFR191 for disposal of high-level waste. Vol. 1

International Nuclear Information System (INIS)

Ortiz, N.R.; Wahi, K.K.

1983-04-01

The Environmental Protection Agency (EPA) has prepared a draft Standard (40CFR191, Draft 19) which, when finalized, will provide the overall system requirements for the geologic disposal of radioactive waste. This document (Vol. 1) provides an Executive Summary of the work performed at Sandia National Laboratories, Albuquerque, NM, under contract to the US Nuclear Regulatory Commission to analyze certain aspects of the draft Standard. The issues of radionuclide release limits, interpretation, uncertainty, achievability, and assessment of compliance with respect to the requirements of the draft Standard are addressed based on the detailed analyses presented in five companion volumes to this report

GHG sustainability compliance of rapeseed-based biofuels produced in a Danish multi-output biorefinery system

International Nuclear Information System (INIS)

Boldrin, Alessio; Astrup, Thomas

2015-01-01

Biofuels are likely to play an increasingly important role in the transportation sector in the coming decades. To ensure the sustainability of the biofuel chain, regulatory criteria and reduction targets for greenhouse gases (GHG) emissions have been defined in different legislative frameworks (e.g. the European Renewable Energy Directive, RED). The provided calculation methods, however, leave room for interpretation regarding methodological choices, which could significantly affect the resulting emission factors. In this study, GHG reduction factors for a range of biofuels produced in a Danish biorefinery system were determined using five different emission allocation principles. The results show that emission savings ranged from −34 % to 71 %, indicating the need for a better definition of regulatory calculation principles. The calculated emission factors differed significantly from default values provided in the literature, suggesting that case-specific local conditions should be taken into consideration. A more holistic LCA-based approach proved useful in overcoming some of the issues inherent in the regulatory allocation principles. On this basis, indirect land use change (ILUC) emissions were shown to have the same magnitude as the direct emissions, thus indicating that the overall system should be included when assessing biofuel sustainability criteria. - Highlights: • Fulfillment of the GHG compliance criteria may depend on the calculation criteria. • Default factors may not be representative of local conditions. • Zero burden approach should be excluded. • ILUC should not be neglected

40 CFR 51.361 - Motorist compliance enforcement.

Science.gov (United States)

2010-07-01

... a testing certification mechanism (either paper-based or electronic) that shall be used for... (iii) Whether the vehicle passed or received a waiver; (4) Routinely issue citations to motorists with... stratification of non-compliance by length of noncompliance and model year. (ii) The program as currently...

An electronic regulatory document management system for a clinical trial network.

Science.gov (United States)

Zhao, Wenle; Durkalski, Valerie; Pauls, Keith; Dillon, Catherine; Kim, Jaemyung; Kolk, Deneil; Silbergleit, Robert; Stevenson, Valerie; Palesch, Yuko

2010-01-01

A computerized regulatory document management system has been developed as a module in a comprehensive Clinical Trial Management System (CTMS) designed for an NIH-funded clinical trial network in order to more efficiently manage and track regulatory compliance. Within the network, several institutions and investigators are involved in multiple trials, and each trial has regulatory document requirements. Some of these documents are trial specific while others apply across multiple trials. The latter causes a possible redundancy in document collection and management. To address these and other related challenges, a central regulatory document management system was designed. This manuscript shares the design of the system as well as examples of it use in current studies. Copyright (c) 2009 Elsevier Inc. All rights reserved.

Alignment of process compliance and monitoring requirements in dynamic business collaborations

Science.gov (United States)

Comuzzi, Marco

2017-07-01

Dynamic business collaborations are intrinsically characterised by change because processes can be distributed or outsourced and partners may be substituted by new ones with enhanced or different capabilities. In this context, compliance requirements management becomes particularly challenging. Partners in a collaboration may join and leave dynamically and tasks over which compliance requirements are specified may be consequently distributed or delegated to new partners. This article considers the issue of aligning compliance requirements in a dynamic business collaboration with the monitoring requirements induced on the collaborating partners when change occurs. We first provide a conceptual model of business collaborations and their compliance requirements, introducing the concept of monitoring capabilities induced by compliance requirements. Then, we present a set of mechanisms to ensure consistency between monitoring and compliance requirements in the presence of change, e.g. when tasks are delegated or backsourced in-house. We also discuss a set of metrics to evaluate the status of a collaboration in respect of compliance monitorability. Finally, we discuss a prototype implementation of our framework.

Use of Monte Carlo modeling approach for evaluating risk and environmental compliance

International Nuclear Information System (INIS)

Higley, K.A.; Strenge, D.L.

1988-09-01

Evaluating compliance with environmental regulations, specifically those regulations that pertain to human exposure, can be a difficult task. Historically, maximum individual or worst-case exposures have been calculated as a basis for evaluating risk or compliance with such regulations. However, these calculations may significantly overestimate exposure and may not provide a clear understanding of the uncertainty in the analysis. The use of Monte Carlo modeling techniques can provide a better understanding of the potential range of exposures and the likelihood of high (worst-case) exposures. This paper compares the results of standard exposure estimation techniques with the Monte Carlo modeling approach. The authors discuss the potential application of this approach for demonstrating regulatory compliance, along with the strengths and weaknesses of the approach. Suggestions on implementing this method as a routine tool in exposure and risk analyses are also presented. 16 refs., 5 tabs

UK regulatory perspective on the application of burn-up credit to the BNFL thorp head end plant

International Nuclear Information System (INIS)

Simister, D.N.; Clemson, P.D.

2003-01-01

In the UK the Health and Safety Executive, which incorporates the Nuclear Installations Inspectorate (NII), is responsible for regulation of safety on nuclear sites. This paper reports progress made in the application and development of a UK regulatory position for assessing licensee's plant safety caes which invoke the use of Burn-up Credit for criticality applications. The NII's principles and strategy for the assessment of this technical area have been developed over a period of time following expressions of interest from UK industry and subsequent involvement in the international collaborations and debate in this area. This experience has now been applied to the first main plant safety case application claiming Burn-up Credit. This case covers the BNFL Thermal Oxide Reprocessing Plant (THORP) dissolver at Sellafield, where dissolved gadolinium neutron poison is used as a criticality control. The case argues for a reduction in gadolinium content by taking credit for the burn-up of input fuel. The UK regulatory process, assessment principles and criteria are briefly outlined, showing the regulatory framework used to review the case. These issues include the fundamental requirement in UK Health and Safety law to demonstrate that risks have been reduced to as low as reasonably practicable (ALARP), the impact on safety margins, compliance and operability procedures, and the need for continuing review. Novel features of methodology, using a ''Residual Enrichment'' and ''Domain Boundary'' approach, were considered and accepted. The underlying validation, both of criticality methodology and isotopic determination, was also reviewed. Compliance was seen to rely heavily on local in-situ measurements of spent fuel used to determine ''Residual Enrichment'' and other parameters, requiring review of the development and basis of the correlations used to underpin the measurement process. Overall, it was concluded that the case as presented was adequate. Gadolinium reduction

Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

Directory of Open Access Journals (Sweden)

M Venkatesh

2011-01-01

Full Text Available Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20 th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.

Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

Science.gov (United States)

Venkatesh, M.; Bairavi, V. G.; Sasikumar, K. C.

2011-01-01

Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20th century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.. PMID:21430959

Regulatory issues associated with exclusion, exemption, and clearance related to the mining and minerals processing industries

International Nuclear Information System (INIS)

Metcalf, P.; Woude, S. van der; Keenan, N.; Guy, S.

1997-01-01

The concepts of exclusion, exemption and clearance have been established in international recommendations and, standards for radiation protection and the management of radioactive waste in recent years. The consistent application of these concepts has given rise to various problems in different spheres of use. This is particularly the case in the mining and minerals processing industries dealing with materials exhibiting elevated concentrations of naturally occurring radionuclides. This paper takes the South African mining industry as an example and highlights some of the issues that have arisen in applying these concepts within a regulatory control regime. (author)

Low-income, minority fathers' control strategies and their children's regulatory skills.

Science.gov (United States)

Malin, Jenessa L; Cabrera, Natasha J; Karberg, Elizabeth; Aldoney, Daniela; Rowe, Meredith L

2014-01-01

The current study explored the bidirectional association of children's individual characteristics, fathers' control strategies at 24 months, and children's regulatory skills at prekindergarten (pre-K). Using a sample of low-income, minority families with 2-year-olds from the Early Head Start Research and Evaluation Project (n = 71), we assessed the association between child gender and vocabulary skills, fathers' control strategies at 24 months (e.g., regulatory behavior and regulatory language), and children's sustained attention and emotion regulation at prekindergarten. There were three main findings. First, fathers overwhelmingly used commands (e.g., "Do that.") to promote compliance in their 24-month-old children. Second, children's vocabulary skills predicted fathers' regulatory behaviors during a father-child interaction whereas children's gender predicted fathers' regulatory language during an interaction. Third, controlling for maternal supportiveness, fathers' regulatory behaviors at 24 months predicted children's sustained attention at pre-K whereas fathers' regulatory language at 24 months predicted children's emotion regulation at pre-K. Our findings highlight the importance of examining paternal contributions to children's regulatory skills. © 2014 Michigan Association for Infant Mental Health.

Regulatory Safety Requirements for Operating Nuclear Installations

International Nuclear Information System (INIS)

Gubela, W.

2017-01-01

The National Nuclear Regulator (NNR) is established in terms of the National Nuclear Regulator Act (Act No 47 of 1999) and its mandate and authority are conferred through sections 5 and 7 of this Act, setting out the NNR's objectives and functions, which include exercising regulatory control over siting, design, construction etc of nuclear installations through the granting of nuclear authorisations. The NNR's responsibilities embrace all those actions aimed at providing the public with confidence and assurance that the risks arising from the production of nuclear energy remain within acceptable safety limits -> Therefore: Set fundamental safety standards, conducting pro-active safety assessments, determining licence conditions and obtaining assurance of compliance. The promotional aspects of nuclear activities in South Africa are legislated by the Nuclear Energy Act (Act No 46 of 1999). The NNR approach to regulations of nuclear safety and security take into consideration, amongst others, the potential hazards associated with the facility or activity, safety related programmes, the importance of the authorisation holder's safety related processes as well as the need to exercise regulatory control over the technical aspects such as of the design and operation of a nuclear facility in ensuring nuclear safety and security. South Africa does not have national nuclear industry codes and standards. The NNR is therefore non-prescriptive as it comes to the use of industry codes and standards. Regulatory framework (current) provide for the protection of persons, property, and environment against nuclear damage, through Licensing Process: Safety standards; Safety assessment; Authorisation and conditions of authorisation; Public participation process; Compliance assurance; Enforcement

Shared Regulatory Regimes through the Lens of Subsidiarity : Towards a Substantive Approach

NARCIS (Netherlands)

Buijze, Anoeska

2014-01-01

This contribution explores the division of regulatory and enforcement competences between the EU and the Member States on a general level. It provides some substantive criteria that can facilitate the judicial review of compliance with the principle of subsidiarity. Alternatively, these criteria can

Compliance and the Acid Rain Program : Discussion paper C3-03

International Nuclear Information System (INIS)

Sandor, K.

2002-01-01

This paper presents the history as well as the implementation and development of the Acid Rain Program and examines whether it was successful in meeting environmental and regulatory goals that led to its enactment. An overview of regulatory policies that influenced sulphur dioxide (SO 2 ) emissions were also presented, along with a discussion regarding emission trends before and after implementation of these policies. The Clean Air Act (CAA) was one of the initial pieces of legislation of the Environmental Protection Agency which was formed in 1970. The CAA was amended in 1990 to provide foundation for the Acid Rain Program. The goal was to reduce acid rain by lowering SO 2 emissions 10 million tons below their 1980 levels to 8.95 million tons by 2010. Innovative emissions cap and trade programs were established to achieve this goal. The first phase of the Acid Rain Program began in 1995 and included 110 of the dirtiest plants emitting SO 2 in the United States. The second phase began in 2000 and included 2,262 operating units. Under the Acid Rain Program, plants have the choice of using technology, previously-implemented controls, retiring plants, and allowances to comply. Many plants are choosing to use more than one of these compliance methods. This paper also discussed the issue of considering emissions trading as a potential component of any future Canadian regulatory policy for greenhouse gases. It was noted that emissions trading provides companies the flexibility to decide how to meet their emissions, or they can pay others to reduce emissions for them. The experience of other jurisdictions were presented in order to effectively design and implement an emissions trading program for greenhouse gases. 16 refs., 1 tab., 8 figs

28 CFR 73.4 - Partial compliance not deemed compliance.

Science.gov (United States)

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Partial compliance not deemed compliance. 73.4 Section 73.4 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) NOTIFICATIONS TO THE ATTORNEY GENERAL BY AGENTS OF FOREIGN GOVERNMENTS § 73.4 Partial compliance not deemed compliance. The fact...

Regulatory control of radiation sources in the Philippines

International Nuclear Information System (INIS)

Daroy, Rosita R.

1995-01-01

This paper is concerned with the radiation protection and safety infrastructure providing emphasis on the regulation and control of radiation sources in the Philippines. It deals with the experiences of the Philippine Nuclear Research Institute, as a regulatory body, in the regulation and control of radioactive materials in radiotherapy, nuclear medicine, industrial radiography, industrial gauges, industrial irradiators, and well logging. This paper includes an inventory of the sources and types of devices/equipment used by licensed users of radioactive materials in the Philippines as a contribution to the data base being prepared by the IAEA. The problems encountered by the regulatory body in the licensing and enforcement process, as well as the lessons learned from incidents involving radioactive materials are discussed. Plans for improving compliance to the regulations and enhancing the effectiveness of PNRI's regulatory functions are presented. (author)

Tax Compliance Inventory: TAX-I Voluntary tax compliance, enforced tax compliance, tax avoidance, and tax evasion

Science.gov (United States)

Kirchler, Erich; Wahl, Ingrid

2010-01-01

Surveys on tax compliance and non-compliance often rely on ad hoc formulated items which lack standardization and empirical validation. We present an inventory to assess tax compliance and distinguish between different forms of compliance and non-compliance: voluntary versus enforced compliance, tax avoidance, and tax evasion. First, items to measure voluntary and enforced compliance, avoidance, and evasion were drawn up (collected from past research and newly developed), and tested empirically with the aim of producing four validated scales with a clear factorial structure. Second, findings from the first analyses were replicated and extended to validation on the basis of motivational postures. A standardized inventory is provided which can be used in surveys in order to collect data which are comparable across research focusing on self-reports. The inventory can be used in either of two ways: either in its entirety, or by applying the single scales independently, allowing an economical and fast assessment of different facets of tax compliance. PMID:20502612

Tax Compliance Inventory: TAX-I Voluntary tax compliance, enforced tax compliance, tax avoidance, and tax evasion.

Science.gov (United States)

Kirchler, Erich; Wahl, Ingrid

2010-06-01

Surveys on tax compliance and non-compliance often rely on ad hoc formulated items which lack standardization and empirical validation. We present an inventory to assess tax compliance and distinguish between different forms of compliance and non-compliance: voluntary versus enforced compliance, tax avoidance, and tax evasion. First, items to measure voluntary and enforced compliance, avoidance, and evasion were drawn up (collected from past research and newly developed), and tested empirically with the aim of producing four validated scales with a clear factorial structure. Second, findings from the first analyses were replicated and extended to validation on the basis of motivational postures. A standardized inventory is provided which can be used in surveys in order to collect data which are comparable across research focusing on self-reports. The inventory can be used in either of two ways: either in its entirety, or by applying the single scales independently, allowing an economical and fast assessment of different facets of tax compliance.

ATMPs for Cancer Immunotherapy: A Regulatory Overview.

Science.gov (United States)

Galli, Maria Cristina

2016-01-01

This chapter discusses European regulatory requirements for development of advanced therapy medicinal products (ATMP) for cancer immunotherapy approaches, describing the framework for clinical trials and for marketing authorization.Regulatory critical issues and challenges for developing ATMP are also discussed, with focus on potency determination, long-term follow-up, comparability, and insertional mutagenesis issues. Some of the most critical features of GMP application to ATMP are also described.

Directory of Certificates of Compliance for Radioactive-Materials Packages. Summary report of NRC approved packages

International Nuclear Information System (INIS)

1983-01-01

This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume I), all Certificates of Compliance (Volume 2), and Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective December 31, 1982. The purpose of this directory is to make available a convenient source of information on packagings which have been approved by the US Nuclear Regulatory Commission. To assist in identifying packaging, an index by Model Number and corresponding Certificate of Compliance Number is included at the back of Volumes 1 and 2 of the directory. A listing by packaging types is included in the back of Volume 2. An alphabetical listing by company name is included in the back of Volume 3 for approved QA programs. The Summary Reports include a listing of all users of each package design and approved QA programs prior to the publication date of the directory

An assessment tool to ensure compliance for the Imperial Oil Cold Lake operations

Energy Technology Data Exchange (ETDEWEB)

Wright, R. [HFP Acoustical Consultants Corp., Calgary, AB (Canada); Nixon, J.K. [Imperial Oil Resources Canada, Calgary, AB (Canada)

2005-07-01

In order to address noise issues at Imperial Oil Resources' (IOR) Cold Lake facility, HFP Acoustical Consultants Corp. was hired to develop a noise assessment tool. The innovative tool which has been used successfully by IOR for the past 2 years to self-monitor IOR's predicted sound level contributions for the Cold Lake Operations Lease area, consists of a noise computer model and a noise assessment spreadsheet. The tool is designed to ensure that the sound levels are below those designated by the Alberta Energy and Utilities Board's (EUB) Permissible Sound Level of 40 dBa from a facility to the nearest or most impacted residence. The tool has exceeded design expectations and goals and the spreadsheet has proven to be effective in predicting non-compliance concerns prior to a new facility being constructed or operated. The tool has been incorporated into IOR's corporate project planning process. The tool has shown that the noise contributions from the Cold Lake Lease area are below the EUB Permissible Sound Levels. IOR does not believe that the noise contribution from this area will increase over the life of the project unless a facility is added close to a residence. The IOR-EUB Compliance Self-Assessment Framework, which allows IOR to self-manage noise for its operations, made it possible for IOR to implement this new, site specific regulatory tool which provides accurate, immediate and auditable due-diligence documentation. 6 refs., 2 figs.

Inspection and enforcement by the regulatory body for nuclear power plants

International Nuclear Information System (INIS)

1980-01-01

This Safety Guide was prepared as part of the Agency's programme, referred to as the NUSS programme, for establishing Codes of Practice and Safety Guides relating to nuclear power plants. It supplements the Code of Practice on Governmental Organization for the Regulation of Nuclear Power Plants, IAEA Safety Series No.50-C-G and should be used in conjunction with that document. The purpose of this Guide is to provide information, guidance and recommendations to assist Member States in (1) establishing and conducting a regulatory inspection programme for nuclear power plants, (2) establishing requirements for the applicant/licensee in regard to regulatory inspection, (3) establishing a system for enforcing compliance with the requirements and decisions of the regulatory body

WTO Compliance Status of the Conservation Security Program (CSP) and the Conservation Reserve Program (CRP)

National Research Council Canada - National Science Library

Schnepf, Randy

2007-01-01

.... This report is not a legal opinion, but describes both the CSP and CRP programs, the WTO Annex II provisions that govern compliance, and the potential issues involved in evaluating the compliance status of the two programs. This report will be updated as events warrant.

Relationship between degree of risk, cost and level of compliance to occupational health and safety regulations in construction

Directory of Open Access Journals (Sweden)

Abimbola Olukemi Windapo

2013-06-01

Full Text Available This paper investigates the role of statutory health and safety (H&S regulations in managing construction project risks. The study examines whether the decision made by contractors to comply with the regulations, the cost of compliance and savings of H&S regulatory requirements is influenced by the degree or level of risk, which the regulations are trying to prevent. The rationale for the examination stems from previous studies which establish that building designers and contractors perceive the cost of complying with regulations as additional burdens, which they have to conform to, and which are in some cases unnecessary, and also the fact that construction related injuries and fatalities are on the increase. Qualitative and quantitative data obtained from a descriptive survey and H&S site audit by the Master Builder Association of the Western Cape (MBAWC were used as the measurements of risk, level of compliance to regulations, cost of compliance and savings. By correlating the quantitative and qualitative data, there is empirical evidence to support a negative relationship between the degree of risk, level and cost of compliance and cost savings. Based on the study’s findings, this paper concludes that the decision made by contractors to comply with H&S regulatory requirements is influenced by the perceived cost saving on account of compliance and that cost savings are influenced by the probability of accident occurrence which is an element of the degree of risk which the regulation is trying to prevent or control. 

Relationship between degree of risk, cost and level of compliance to occupational health and safety regulations in construction

Directory of Open Access Journals (Sweden)

Abimbola Olukemi Windapo

2013-06-01

Full Text Available This paper investigates the role of statutory health and safety (H&S regulations in managing construction project risks. The study examines whether the decision made by contractors to comply with the regulations, the cost of compliance and savings of H&S regulatory requirements is influenced by the degree or level of risk, which the regulations are trying to prevent. The rationale for the examination stems from previous studies which establish that building designers and contractors perceive the cost of complying with regulations as additional burdens, which they have to conform to, and which are in some cases unnecessary, and also the fact that construction related injuries and fatalities are on the increase. Qualitative and quantitative data obtained from a descriptive survey and H&S site audit by the Master Builder Association of the Western Cape (MBAWC were used as the measurements of risk, level of compliance to regulations, cost of compliance and savings. By correlating the quantitative and qualitative data, there is empirical evidence to support a negative relationship between the degree of risk, level and cost of compliance and cost savings. Based on the study’s findings, this paper concludes that the decision made by contractors to comply with H&S regulatory requirements is influenced by the perceived cost saving on account of compliance and that cost savings are influenced by the probability of accident occurrence which is an element of the degree of risk which the regulation is trying to prevent or control.

ENSI’s regulatory framework strategy; Regelwerksstrategie des ENSI -- Stratégie réglementaire de l’IFSN -- ENSI’s regulatory framework strategy

Energy Technology Data Exchange (ETDEWEB)

NONE

2015-03-15

This short brochure issued by the Swiss Federal Nuclear Safety Inspectorate ENSI defines the organisation’s regulatory framework strategy. Six guiding principles are declared and discussed: Comprehensive harmonisation with relevant international requirements, basing the regulatory framework on existing, tried-and-tested regulations, issuing of its own guidelines only when it is necessary to do so, guidelines to be drawn up transparently and with the involvement of all stakeholders and basing the level of detail of its regulatory framework on hazard potential and risk.

Compliance of blood sampling procedures with the CLSI H3-A6 guidelines

DEFF Research Database (Denmark)

Simundic, A. M.; Church, S.; Cornes, M. P.

2015-01-01

compliance with the recommended CLSI guideline. Patient identification and test tube labelling were identified as the key guideline issues with the highest combination of probability and potential risk of harm. Administrative staff did not adhere to patient identification procedures during phlebotomy...... are patient identification and tube labelling....... checklist including 29 items was created to assess the compliance of European phlebotomy procedures with the CLSI H3-A6 guideline. A risk occurrence chart of individual phlebotomy steps was created from the observed error frequency and severity of harm of each guideline key issue. The severity of errors...

Regulatory analysis for the resolution of Generic Issue 99: Loss of RHR [residual heat removal] capability in PWRs

International Nuclear Information System (INIS)

Spano, A.H.

1989-02-01

Generic Issue 99 is concerned with the loss of residual heat removal (RHR) capability in pressurized water reactors during cold-plant outage operations. The issue focuses on two risk-significant common-cause failure modes of the RHR system: (1) air binding of the RHR pumps during reduced-inventory operations and (2) spurious closure of the RHR suction valves due to misapplication of the autoclosure interlocks. Resolution of this issue involves consideration of the adequacy of plant capabilities for (1) preventing losses of RHR, (2) responding promptly and effectively to such challenges in order to prevent core damage, and (3) ensuring timely containment protection against the release of radioactivity to the environment in the unlikely event of core damage due to loss of shutdown cooling. This entails examination of (1) relevant operational and accident response procedures, (2) the instrumentation available to the operator for accident diagnosis and mitigation, and (3) the administrative controls available for ensuring control room cognizance of ongoing maintenance activities that could potentially affect the stability of the reactor coolant system. This regulatory analysis provides quantitative assessments of the costs and benefits associated with several alternatives considered for the resolution of Generic Issue 99. 24 refs

Steam generators regulatory practices and issues in Spain

International Nuclear Information System (INIS)

Mendoza, C.; Castelao, C.; Ruiz-Colino, J.; Figueras, J.M.

1997-01-01

This paper presents the actual status of Spanish Steam Generator tubes, actions developed by PWR plant owners and submitted to CSN, and regulatory activities related to tube degradation mechanisms analysis; NDT tube inspection techniques; tube, tubesheet and TSPs integrity studies; tube plugging/repair criteria; preventive and corrective measures including whole SGs replacement; tube leak measurement methods and other operational aspects

Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

Energy Technology Data Exchange (ETDEWEB)

Gamboa, Maryelle Moreira Lima; Roesch, Heveline Rayane Moura; Lemos, Vanessa Pinheiro Amaral, E-mail: maryellelg@hotmail.com [PPG BioSaude, Universidade Luterana do Brasil, Canoas, RS (Brazil); Rocha, Bruna Oliveira [Faculty of Biology, Universidade Luterana do Brasil, Canoas, RS (Brazil); Santos-Oliveira, Ralph [Institute of Radiopharmacy Research, Universidade Estadual da Zona Oeste, Rio de Janeiro, RJ (Brazil)

2014-04-15

Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. >From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs. (author)

Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

International Nuclear Information System (INIS)

Gamboa, Maryelle Moreira Lima; Roesch, Heveline Rayane Moura; Lemos, Vanessa Pinheiro Amaral; Rocha, Bruna Oliveira; Santos-Oliveira, Ralph

2014-01-01

Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. >From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs. (author)

Environmental Assessment of Ground Water Compliance at the Naturita, Colorado, UMTRA Project Site

Energy Technology Data Exchange (ETDEWEB)

None

2003-04-23

This Environmental Assessment addresses the environmental effects of a proposed action and the no action alternative to comply with U.S. Environmental Protection Agency (EPA) ground water standards at the Naturita, Colorado, Uranium Mill Tailings Remedial Action Project site. In 1998, the U.S. Department of Energy (DOE) completed surface cleanup at the site and encapsulated the tailings in a disposal cell 15 miles northwest near the former town of Uravan, Colorado. Ground water contaminants of potential concern at the Naturita site are uranium and vanadium. Uranium concentrations exceed the maximum concentration limit (MCL) of 0.044 milligram per liter (mg/L). Vanadium has no MCL; however, vanadium concentrations exceed the EPA Region III residential risk-based concentration of 0.33 mg/L (EPA 2002). The proposed compliance strategy for uranium and vanadium at the Naturita site is no further remediation in conjunction with the application of alternate concentration limits. Institutional controls with ground water and surface water monitoring will be implemented for these constituents as part of the compliance strategy. This compliance strategy will be protective of human health and the environment. The proposed monitoring program will begin upon regulatory concurrence with the Ground Water Compliance Action Plan (DOE 2002a). Monitoring will consist of verifying that institutional controls remain in place, collecting ground water samples to verify that concentrations of uranium and vanadium are decreasing, and collecting surface water samples to verify that contaminant concentrations do not exceed a regulatory limit or risk-based concentration. If these criteria are not met, DOE would reevaluate the proposed action and determine the need for further National Environmental Policy Act documentation. No comments were received from the public during the public comment period. Two public meetings were held during this period. Minutes of these meetings are included as

Environmental Assessment of Ground Water Compliance at the Naturita, Colorado, UMTRA Project Site

International Nuclear Information System (INIS)

2003-01-01

This Environmental Assessment addresses the environmental effects of a proposed action and the no action alternative to comply with U.S. Environmental Protection Agency (EPA) ground water standards at the Naturita, Colorado, Uranium Mill Tailings Remedial Action Project site. In 1998, the U.S. Department of Energy (DOE) completed surface cleanup at the site and encapsulated the tailings in a disposal cell 15 miles northwest near the former town of Uravan, Colorado. Ground water contaminants of potential concern at the Naturita site are uranium and vanadium. Uranium concentrations exceed the maximum concentration limit (MCL) of 0.044 milligram per liter (mg/L). Vanadium has no MCL; however, vanadium concentrations exceed the EPA Region III residential risk-based concentration of 0.33 mg/L (EPA 2002). The proposed compliance strategy for uranium and vanadium at the Naturita site is no further remediation in conjunction with the application of alternate concentration limits. Institutional controls with ground water and surface water monitoring will be implemented for these constituents as part of the compliance strategy. This compliance strategy will be protective of human health and the environment. The proposed monitoring program will begin upon regulatory concurrence with the Ground Water Compliance Action Plan (DOE 2002a). Monitoring will consist of verifying that institutional controls remain in place, collecting ground water samples to verify that concentrations of uranium and vanadium are decreasing, and collecting surface water samples to verify that contaminant concentrations do not exceed a regulatory limit or risk-based concentration. If these criteria are not met, DOE would reevaluate the proposed action and determine the need for further National Environmental Policy Act documentation. No comments were received from the public during the public comment period. Two public meetings were held during this period. Minutes of these meetings are included as

NRC regulatory uses of PSA

International Nuclear Information System (INIS)

Murley, T.E.

1991-01-01

The publication in 1975 of WASH-1400, with its new probabilistic safety assessment (PSA) methodology, had the effect of presenting a pair of eyeglasses to a man with poor eyesight. Suddenly, it gave us a view of nuclear safety with a new clarity, and it allowed us to sort out the important safety issues from the unimportant. In the intervening years, PSA insights have permeated the fabric of nearly all our safety judgments. This acceptance can be seen from the following list of broad areas where the Nuclear Regulatory Commission (NRC) staff uses PSA insights and methodology: evaluating the safety significance of operating events and recommending safety improvements where warranted; requesting licensees to systematically look for design vulnerabilities in each operating reactor; evaluating the safety significance of design weaknesses or non-compliances when judging the time frame for necessary improvements; conducting sensitivity analyses to judge where safety improvements are most effective; assessing the relative safety benefits of design features for future reactors. In judging where PSA methodology can be improved to give better safety insights, it is believed that the following areas need more attention: better modeling of cognitive errors; more comprehensive modeling of accident sequences initiated from conditions other than full power; more comprehensive modeling of inter-system loss of coolant accident (ISLOCA) sequences. Although PSA is widely used in the staff's regulatory activities, the NRC deliberately chooses not to include probabilistic prescriptions in regulations or guidance documents. The staff finds the bottom line risk estimates to be one of the least reliable products of a PSA. The reason for this view is that PSA cannot adequately address cognitive errors nor assess the effects of a pervasive poor safety attitude

Environmental challenges and opportunities of the evolving North American electricity market : European electricity generating facilities: an overview of European regulatory requirements and standardization efforts

International Nuclear Information System (INIS)

Nichols, L.

2002-06-01

Several factors are affecting power generating facilities, such as the opening of both electricity and gas markets, and the pressure applied on generators and governments to ensure a steady energy supply for consumers. An additional factor is the pressure for the closing of nuclear power facilities. European siting and emissions requirements for coal-fired and natural gas generating facilities were presented in this background paper. In addition, the author provided an overview of the standardization process in place in Europe. The European Union and its functioning were briefly described, as well as a listing of relevant organizations. The current trends were examined. The document first introduced the European Union, and the next section dealt with Regulatory regime: the internal energy market. The third section examined the issue of Regulatory regime: generation and environmental regulations. Section four presented environmental management systems, followed by a section on standardization. Section six discussed European organizations involved in electricity issues, while the following section dealt with European commission programs. The last section briefly looked at the trends in the electricity sector, broaching topics such as compliance, electricity generation, and emissions trading. 52 refs., 2 tabs

An overview of the licensing approach of the South African nuclear regulatory authority

International Nuclear Information System (INIS)

Clapisson, G.A.; Hill, T.F.; Henderson, N.R.; Keenan, N.H.; Metcalf, P.E.; Mysenkov, A.

1997-01-01

This paper describes the approach adopted by the South African Nuclear Regulatory Authority, the Council for Nuclear Safety (CNS) in licensing nuclear installations in South Africa. An introduction to the current South African legislation and the CNS philosophy pertaining to the licensing of nuclear installations is discussed. A typical process for granting a nuclear licence is then presented. The risk assessment process, which is used to verify compliance with the fundamental safety standards and to establish licensing requirements for a specific nuclear installation, is discussed. Based on the outcome of this assessment process, conditions of licence are set down. The generic content of a nuclear licence and mechanisms to ensure ongoing compliance with the risk criteria are presented. The regulatory process discussed in this paper, based on such a fundamental approach, may be adapted to any type of nuclear installation taking into account plant specific designs and characteristics. (author)

Methods for verifying compliance with low-level radioactive waste acceptance criteria

Energy Technology Data Exchange (ETDEWEB)

NONE

1993-09-01

This report summarizes the methods that are currently employed and those that can be used to verify compliance with low-level radioactive waste (LLW) disposal facility waste acceptance criteria (WAC). This report presents the applicable regulations representing the Federal, State, and site-specific criteria for accepting LLW. Typical LLW generators are summarized, along with descriptions of their waste streams and final waste forms. General procedures and methods used by the LLW generators to verify compliance with the disposal facility WAC are presented. The report was written to provide an understanding of how a regulator could verify compliance with a LLW disposal facility`s WAC. A comprehensive study of the methodology used to verify waste generator compliance with the disposal facility WAC is presented in this report. The study involved compiling the relevant regulations to define the WAC, reviewing regulatory agency inspection programs, and summarizing waste verification technology and equipment. The results of the study indicate that waste generators conduct verification programs that include packaging, classification, characterization, and stabilization elements. The current LLW disposal facilities perform waste verification steps on incoming shipments. A model inspection and verification program, which includes an emphasis on the generator`s waste application documentation of their waste verification program, is recommended. The disposal facility verification procedures primarily involve the use of portable radiological survey instrumentation. The actual verification of generator compliance to the LLW disposal facility WAC is performed through a combination of incoming shipment checks and generator site audits.

Methods for verifying compliance with low-level radioactive waste acceptance criteria

International Nuclear Information System (INIS)

1993-09-01

This report summarizes the methods that are currently employed and those that can be used to verify compliance with low-level radioactive waste (LLW) disposal facility waste acceptance criteria (WAC). This report presents the applicable regulations representing the Federal, State, and site-specific criteria for accepting LLW. Typical LLW generators are summarized, along with descriptions of their waste streams and final waste forms. General procedures and methods used by the LLW generators to verify compliance with the disposal facility WAC are presented. The report was written to provide an understanding of how a regulator could verify compliance with a LLW disposal facility's WAC. A comprehensive study of the methodology used to verify waste generator compliance with the disposal facility WAC is presented in this report. The study involved compiling the relevant regulations to define the WAC, reviewing regulatory agency inspection programs, and summarizing waste verification technology and equipment. The results of the study indicate that waste generators conduct verification programs that include packaging, classification, characterization, and stabilization elements. The current LLW disposal facilities perform waste verification steps on incoming shipments. A model inspection and verification program, which includes an emphasis on the generator's waste application documentation of their waste verification program, is recommended. The disposal facility verification procedures primarily involve the use of portable radiological survey instrumentation. The actual verification of generator compliance to the LLW disposal facility WAC is performed through a combination of incoming shipment checks and generator site audits

Dismantlement of nuclear facilities decommissioned from the Russian navy: Enhancing regulatory supervision of nuclear and radiation safety

International Nuclear Information System (INIS)

Sneve, M.K.

2013-01-01

The availability of up to date regulatory norms and standards for nuclear and radiation safety, relevant to the management of nuclear legacy situations, combined with effective and efficient regulatory procedures for licensing and monitoring compliance, are considered to be extremely important. Accordingly the NRPA has set up regulatory cooperation programs with corresponding authorities in the Russian Federation. Cooperation began with the civilian regulatory authorities and was more recently extended to include the military authority and this joint cooperation supposed to develop the regulatory documents to improve supervision over nuclear and radiation safety while managing the nuclear military legacy facilities in Northwest Russia and other regions of the country. (Author)

Dismantlement of nuclear facilities decommissioned from the Russian navy: Enhancing regulatory supervision of nuclear and radiation safety

Energy Technology Data Exchange (ETDEWEB)

Sneve, M.K.

2013-03-01

The availability of up to date regulatory norms and standards for nuclear and radiation safety, relevant to the management of nuclear legacy situations, combined with effective and efficient regulatory procedures for licensing and monitoring compliance, are considered to be extremely important. Accordingly the NRPA has set up regulatory cooperation programs with corresponding authorities in the Russian Federation. Cooperation began with the civilian regulatory authorities and was more recently extended to include the military authority and this joint cooperation supposed to develop the regulatory documents to improve supervision over nuclear and radiation safety while managing the nuclear military legacy facilities in Northwest Russia and other regions of the country. (Author)

DOE regulatory reform initiative vitrified mixed waste

International Nuclear Information System (INIS)

Carroll, S.J.; Holtzscheiter, E.W.

1997-01-01

The US Department of Energy (DOE) is charged with responsibly managing the largest volume of mixed waste in the United States. This responsibility includes managing waste in compliance with all applicable Federal and State laws and regulations, and in a cost-effective, environmentally responsible manner. Managing certain treated mixed wastes in Resource Conservation and Recovery Act (RCRA) permitted storage and disposal units (specifically those mixed wastes that pose low risks from the hazardous component) is unlikely to provide additional protection to human health and the environment beyond that afforded by managing these wastes in storage and disposal units subject to requirements for radiological control. In October, 1995, the DOE submitted a regulatory reform proposal to the Environmental Protection Agency (EPA) relating to vitrified mixed waste forms. The technical proposal supports a regulatory strategy that would allow vitrified mixed waste forms treated through a permit or other environmental compliance mechanism to be granted an exemption from RCRA hazardous waste regulation, after treatment, based upon the inherent destruction and immobilization capabilities of vitrification technology. The vitrified waste form will meet, or exceed the performance criteria of the Environmental Assessment (EA) glass that has been accepted as an international standard for immobilizing radioactive waste components and the LDR treatment standards for inorganics and metals for controlling hazardous constituents. The proposal further provides that vitrified mixed waste would be responsibly managed under the Atomic Energy Act (AEA) while reducing overall costs. Full regulatory authority by the EPA or a State would be maintained until an acceptable vitrified mixed waste form, protective of human health and the environment, is produced

Mercury issues related to NPDES and the CERCLA watershed project at the Oak Ridge Y-12 Plant

International Nuclear Information System (INIS)

1996-11-01

The purpose of this document is to present the current understanding of the issues and options surrounding compliance with the current National Pollutant Discharge Elimination System (NPDES) permit conditions. This is a complicated issue that directly impacts, and will be directly impacted by, ongoing CERCLA activities in Lower East Fork Poplar Creek and the Clinch River/Poplar Creek. It may be necessary to reconstitute the whole and combine actions and decisions regarding the entire creek (origin to confluence with the Clinch River) to develop a viable long-term strategy that meets regulatory goals and requirements as well as those of DOE's 10-Year Plan and the new watershed management permitting approach. This document presents background information on the Reduction of Mercury in Plant Effluents (RMPE) and NPDES programs insofar as it is needed to understand the issues and options. A tremendous amount of data has been collected to support the NPDES/RMPE and CERCLA programs. These data are not presented, although they may be referenced and conclusions based on them may be presented, as necessary, to support discussion of the options

Lifecycle business process compliance management : a semantically-enabled framework

NARCIS (Netherlands)

Elgammal, A.; Turetken, O.

2015-01-01

Following the crisis in 2008, different industrial sectors has faced growing numbers of laws and regulations globally. The number and complexity of these regulations is creating significant issues for governance, risk and compliance management especially for heavily-regulated sectors, such as the

To what extent can the different responses of the United States and the European Union to the Volkswagen Scandal be explained by their different applications of performance-based regulation?

OpenAIRE

Booker, Douglas; Wright, Nick

2016-01-01

The revelation that Volkswagen had employed an illegal “defeat device” to comply with regulation, but fundamentally side-step some emission controls during realworld driving, has thrust the issue of regulatory non-compliance into the spotlight. A growing base of evidence has indicated that one of the underlying reasons for the observed emissions discrepancies, and subsequently the Volkswagen Scandal, is shortcomings in regulatory compliance protocols. This has raised questions about the effic...

National Environmental Policy Act (NEPA) Compliance Guide, Sandia National Laboratories

Energy Technology Data Exchange (ETDEWEB)

Hansen, R.P. [Hansen Environmental Consultants, Englewood, CO (United States)

1995-08-01

This report contains a comprehensive National Environmental Policy Act (NEPA) Compliance Guide for the Sandia National Laboratories. It is based on the Council on Environmental Quality (CEQ) NEPA regulations in 40 CFR Parts 1500 through 1508; the US Department of Energy (DOE) N-EPA implementing procedures in 10 CFR Part 102 1; DOE Order 5440.1E; the DOE ``Secretarial Policy Statement on the National Environmental Policy Act`` of June 1994- Sandia NEPA compliance procedures-, and other CEQ and DOE guidance. The Guide includes step-by-step procedures for preparation of Environmental Checklists/Action Descriptions Memoranda (ECL/ADMs), Environmental Assessments (EAs), and Environmental Impact Statements (EISs). It also includes sections on ``Dealing With NEPA Documentation Problems`` and ``Special N-EPA Compliance Issues.``

Compliance to antihypertensive therapy

International Nuclear Information System (INIS)

Almas, A.; Hameed, A.; Ahmed, B.; Islam, M.

2006-01-01

Objective: To determine compliance, factors affecting compliance to antihypertensive therapy and to compare compliant and non-compliant groups, in a tertiary care setting. Study Design: Analytical (cross-sectional) study. Place and Duration of Study: The outpatient clinics at the Aga Khan University from May 2004 to February 2005. Patients and Methods: Two hundred patients presenting to the outpatients clinic were included. All patients 18 years and above, who had stage 1 and 2 hypertension, had one clinic visit to a medicine clinic, 6 months prior to presentation and started on antihypertensive medicines, were included. Results: Sixty-six percent were males and 33.5 % were females. Mean age was 58.1 ( +- 12) years and mean duration of hypertension was 7.2 (+- 6.7) years. Fifty-seven percent were compliant and 43% were noncompliant. In the noncompliant group, 53.4 % had mild noncompliance, 24.4 % had severe non-compliance, while 22% had moderate noncompliance. Factors of noncompliance were 56.8% missed doses due to forgetfulness, 12.7% deliberately missed their doses, 11.6% could not take the medicine due to side effects, 10.4% did not take the dose due to increased number of tablets, 4.6% were not properly counseled by the physician and 3.48% did not take medicines due to cost issues. The mean systolic blood pressure was 126 +- 19.2 mmHg in the compliant group while it was 133 +- 16.5 mmHg in the noncompliant group (p-value 0.004). The mean diastolic blood pressure in the compliant group was 76 +- 11.9 mmHg, while in the noncompliant group it was 81.9 +- 10.9 mmHg (p-value 0.001). Conclusion: Compliance to antihypertensive therapy in a tertiary care center is significantly good. Forgetfulness was the major reason for noncompliance. The mean blood pressure control was better in the compliant group. (author)

Compliance with children's television food advertising regulations in Australia.

Science.gov (United States)

Roberts, Michele; Pettigrew, Simone; Chapman, Kathy; Miller, Caroline; Quester, Pascale

2012-10-05

The objective of this study was to assess the effectiveness of the Australian co-regulatory system in limiting children's exposure to unhealthy television food advertising by measuring compliance with mandatory and voluntary regulations. An audit was conducted on food and beverage television advertisements broadcast in five major Australian cities during children's programming time from 1st September 2010 to 31st October 2010. The data were assessed against mandatory and voluntary advertising regulations, the information contained in an industry report of breaches, and the Australian Guide to Healthy Eating. During the two months of data collection there were a total of 951 breaches of the combined regulations. This included 619 breaches of the mandatory regulations (CTS) and 332 breaches of the voluntary regulations (RCMI and QSRI). Almost 83% of all food and beverages advertised during children's programming times were for foods classified as 'Extras' in the Australian Guide to Healthy Eating. There were also breaches in relation to the amount of advertising repetition and the use of promotional appeals such as premium offers, competitions, and endorsements by popular children's characters. The self-regulatory systems were found to have flaws in their reporting and there were errors in the Australian Food and Grocery Council's compliance report. This audit suggests that current advertising regulations are inadequate. Regulations need to be closely monitored and more tightly enforced to protect children from advertisements for unhealthy foods.

76 FR 60939 - Metal Fatigue Analysis Performed by Computer Software

Science.gov (United States)

2011-09-30

... Software AGENCY: Nuclear Regulatory Commission. ACTION: Regulatory issue summary; request for comment... computer software package, WESTEMS TM , to demonstrate compliance with Section III, ``Rules for... Software Addressees All holders of, and applicants for, a power reactor operating license or construction...

Protecting the public or setting the bar too high? Understanding the causes and consequences of regulatory actions of front-line regulators and specialized drug shop operators in Kenya.

Science.gov (United States)

Wafula, Francis; Molyneux, Catherine; Mackintosh, Maureen; Goodman, Catherine

2013-11-01

The problem of poor regulatory compliance has been widely reported across private health providers in developing countries. Less known are the underlying reasons for poor compliance, especially with regards to the roles played by front-line regulatory staff, and the regulatory institution as a whole. We designed a qualitative study to address this gap, with the study questions and tools drawing on a conceptual framework informed by theoretical literature on regulation. Data were collected from specialized drug shops (SDSs) in two rural districts in Western Kenya in 2011 through eight focus group discussions, and from regulatory staff from organizations governing the pharmaceutical sector through a total of 24 in-depth interviews. We found that relationships between front-line regulators and SDS operators were a strong influence on regulatory behaviour, often resulting in non-compliance and perverse outcomes such as corruption. It emerged that separate regulatory streams operated in urban and rural locations, based mainly on differing relationships between the front-line regulators and SDS operators, and on broader factors such as the competition environment and community expectations. Effective incentive structures for regulatory staff were either absent, or poorly linked to performance in regulatory organizations, resulting in divergences between the purposes of the regulatory organization and activities of front-line staff. Given the rural-urban differences in the practice environment, the introduction of lower retail practice requirements for rural SDSs could be considered. This would allow illegally operated shops to be brought within the regulatory framework, facilitating good quality provision of essential commodities to marginalized areas, without lowering the practice requirements for the better complying urban SDSs. In addition, regulatory organizations need to devise incentives that better link the level of effort to rewards such as professional

Efficient Semantics-Based Compliance Checking Using LTL Formulae and Unfolding

Directory of Open Access Journals (Sweden)

Liang Song

2013-01-01

Full Text Available Business process models are required to be in line with frequently changing regulations, policies, and environments. In the field of intelligent modeling, organisations concern automated business process compliance checking as the manual verification is a time-consuming and inefficient work. There exist two key issues for business process compliance checking. One is the definition of a business process retrieval language that can be employed to capture the compliance rules, the other concerns efficient evaluation of these rules. Traditional syntax-based retrieval approaches cannot deal with various important requirements of compliance checking in practice. Although a retrieval language that is based on semantics can overcome the drawback of syntax-based ones, it suffers from the well-known state space explosion. In this paper, we define a semantics-based process model query language through simplifying a property specification pattern system without affecting its expressiveness. We use this language to capture semantics-based compliance rules and constraints. We also propose a feasible approach in such a way that the compliance checking will not suffer from the state space explosion as much as possible. A tool is implemented to evaluate the efficiency. An experiment conducted on three model collections illustrates that our technology is very efficient.

Grand Gulf-prioritization of regulatory requirements

International Nuclear Information System (INIS)

Meisner, M.J.

1993-01-01

As cost pressures mount, Grand Gulf nuclear station (GGNS) is relying increasingly on various prioritization approaches to implement, modify, eliminate, or defer regulatory requirements. Regulatory requirements can be prioritized through the use of three measures: (1) safety (or risk) significance; (2) cost; and (3) public policy (or political) significance. This paper summarizes GGNS' efforts to implement solutions to regulatory issues using these three prioritization schemes to preserve a balance between cost and safety benefit

The role of the psychiatrist in improving patient compliance.

Science.gov (United States)

Hotujac, Ljubomir

2007-02-01

Compliance, usually referring to how well the patient takes the medication as prescribed, is an important issue in clinical practice. However, many patients, especially those with a psychiatric illness, stop taking their medications despite physician advice to continue. This cessation can lead to a deterioration in the condition, a relapse, or a recurrence of the illness. In the literature, many different factors contributing to poor compliance have been described, but the doctor's role and responsibilities are hardly mentioned. These factors will be discussed here with special emphasis on what a doctor should do and what a doctor should avoid.

Advanced Reactor Technologies - Regulatory Technology Development Plan (RTDP)

Energy Technology Data Exchange (ETDEWEB)

Moe, Wayne L. [Idaho National Lab. (INL), Idaho Falls, ID (United States)

2017-08-23

This DOE-NE Advanced Small Modular Reactor (AdvSMR) regulatory technology development plan (RTDP) will link critical DOE nuclear reactor technology development programs to important regulatory and policy-related issues likely to impact a “critical path” for establishing a viable commercial AdvSMR presence in the domestic energy market. Accordingly, the regulatory considerations that are set forth in the AdvSMR RTDP will not be limited to any one particular type or subset of advanced reactor technology(s) but rather broadly consider potential regulatory approaches and the licensing implications that accompany all DOE-sponsored research and technology development activity that deal with commercial non-light water reactors. However, it is also important to remember that certain “minimum” levels of design and safety approach knowledge concerning these technology(s) must be defined and available to an extent that supports appropriate pre-licensing regulatory analysis within the RTDP. Final resolution to advanced reactor licensing issues is most often predicated on the detailed design information and specific safety approach as documented in a facility license application and submitted for licensing review. Because the AdvSMR RTDP is focused on identifying and assessing the potential regulatory implications of DOE-sponsored reactor technology research very early in the pre-license application development phase, the information necessary to support a comprehensive regulatory analysis of a new reactor technology, and the resolution of resulting issues, will generally not be available. As such, the regulatory considerations documented in the RTDP should be considered an initial “first step” in the licensing process which will continue until a license is issued to build and operate the said nuclear facility. Because a facility license application relies heavily on the data and information generated by technology development studies, the anticipated regulatory

Advanced Reactor Technology -- Regulatory Technology Development Plan (RTDP)

Energy Technology Data Exchange (ETDEWEB)

Moe, Wayne Leland [Idaho National Lab. (INL), Idaho Falls, ID (United States)

2015-05-01

This DOE-NE Advanced Small Modular Reactor (AdvSMR) regulatory technology development plan (RTDP) will link critical DOE nuclear reactor technology development programs to important regulatory and policy-related issues likely to impact a “critical path” for establishing a viable commercial AdvSMR presence in the domestic energy market. Accordingly, the regulatory considerations that are set forth in the AdvSMR RTDP will not be limited to any one particular type or subset of advanced reactor technology(s) but rather broadly consider potential regulatory approaches and the licensing implications that accompany all DOE-sponsored research and technology development activity that deal with commercial non-light water reactors. However, it is also important to remember that certain “minimum” levels of design and safety approach knowledge concerning these technology(s) must be defined and available to an extent that supports appropriate pre-licensing regulatory analysis within the RTDP. Final resolution to advanced reactor licensing issues is most often predicated on the detailed design information and specific safety approach as documented in a facility license application and submitted for licensing review. Because the AdvSMR RTDP is focused on identifying and assessing the potential regulatory implications of DOE-sponsored reactor technology research very early in the pre-license application development phase, the information necessary to support a comprehensive regulatory analysis of a new reactor technology, and the resolution of resulting issues, will generally not be available. As such, the regulatory considerations documented in the RTDP should be considered an initial “first step” in the licensing process which will continue until a license is issued to build and operate the said nuclear facility. Because a facility license application relies heavily on the data and information generated by technology development studies, the anticipated regulatory

The Current G20 Taxation Agenda: Compliance, Accountability and Legitimacy

Directory of Open Access Journals (Sweden)

Dries Lesage

2014-11-01

Full Text Available This article analyzes the recent G20 initiatives on taxation, more precisely on “base erosion and profit shifting” (BEPS in the area of corporate taxation and the new G20 norm of automatic exchange of information (AEoI with regard to foreign accounts. After having reflected on the special relationship between the G20 and the OECD, the discussion proceeds through the lens of compliance, accountability and legitimacy. In terms of compliance, the G20 is still in the phase of delivering as a group on recent promises with regard to global standard setting. Compliance to these standards by G20 member states (and third countries is expected to start in the coming years. As to accountability, the G20 and OECD already have ample experience with the peer-review process and public reporting on the G20/OECD standard of information exchange upon request. For AEoI and BEPS the OECD will be designated as the prime mechanism to monitor compliance as well. Both initiatives, which are attempts at universal governance, suffer from legitimacy issues, more precisely because the G20 and OECD exclude most developing countries. Moreover, the policy outputs are not necessarily adjusted to developing countries’ needs and interests. Since a few years, both G20 and OECD attempt to address this issue through institutional fixes, extensive consultations with developing countries and modifications at the level of content.

Regulatory and technical reports (abstract index journal)

International Nuclear Information System (INIS)

1994-06-01

This compilation consists of bibliographic data and abstracts for the formal regulatory and technical reports issued by the US Nuclear Regulatory Commission (NRC) Staff and its contractors. It is NRC's intention to publish this compilation quarterly and to cumulate it annually

Regulatory Models and the Environment: Practice, Pitfalls, and Prospects

Energy Technology Data Exchange (ETDEWEB)

Holmes, K. John; Graham, Judith A.; McKone, Thomas; Whipple, Chris

2008-06-01

Computational models support environmental regulatory activities by providing the regulator an ability to evaluate available knowledge, assess alternative regulations, and provide a framework to assess compliance. But all models face inherent uncertainties, because human and natural systems are always more complex and heterogeneous than can be captured in a model. Here we provide a summary discussion of the activities, findings, and recommendations of the National Research Council's Committee on Regulatory Environmental Models, a committee funded by the US Environmental Protection Agency to provide guidance on the use of computational models in the regulatory process. Modeling is a difficult enterprise even outside of the potentially adversarial regulatory environment. The demands grow when the regulatory requirements for accountability, transparency, public accessibility, and technical rigor are added to the challenges. Moreover, models cannot be validated (declared true) but instead should be evaluated with regard to their suitability as tools to address a specific question. The committee concluded that these characteristics make evaluation of a regulatory model more complex than simply comparing measurement data with model results. Evaluation also must balance the need for a model to be accurate with the need for a model to be reproducible, transparent, and useful for the regulatory decision at hand. Meeting these needs requires model evaluation to be applied over the"life cycle" of a regulatory model with an approach that includes different forms of peer review, uncertainty analysis, and extrapolation methods than for non-regulatory models.

Compliance/adherence and care management in HIV disease.

Science.gov (United States)

Crespo-Fierro, M

1997-01-01

With the changing perspectives of the HIV epidemic and the introduction of protease inhibitors to treat human immunodeficiency virus (HIV) disease, the issue of compliance has gained considerable interest among health care providers. The idea that clients with HIV disease should succumb to a patriarchal system of medical care has been challenged by AIDS activists since the beginning of the epidemic. The concept that there is only one explanation for "noncompliance" is outdated. The reasons for noncompliance are multifaceted in nature and include psychosocial factors, complex medication and treatment regimens, ethnocultural concerns, and in many instances substance use. Therefore, the notion that there is one intervention to resolve noncompliance is at best archaic. Interventions to enhance compliance include supervised therapy, improving the nurse-client relationship, and patient education, all of which should be combined with ethnocultural interventions. Plans to enhance compliance must incorporate person-specific variables and should be tailored to individualized needs.

TU-AB-204-02: Device Adverse Events and Compliance

International Nuclear Information System (INIS)

Gonzales, S.

2016-01-01

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-02: Device Adverse Events and Compliance

Energy Technology Data Exchange (ETDEWEB)