WorldWideScience

Sample records for demonstrating regulatory compliance

  1. 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of Transportation (DOT) and the US Nuclear Regulatory Commission (NRC) have jointly prepared a comprehensive set of draft guidance for consignors and inspectors to use when applying the newly imposed regulatory requirements for low specific activity (LSA) material and surface contaminated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 In the draft guidance, one such approach would assist consignors preparing a shipment of a large number of SCOs in demonstrating compliance without unnecessarily exposing personnel.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

  2. Understanding how to maintain compliance in the current regulatory climate

    International Nuclear Information System (INIS)

    Bignell, D.T.; Burns, R.

    1995-01-01

    High level radioactive waste facilities must maintain compliance with all regulatory requirements, even those requirements that have been promulgated after the facility was placed into operation. Facilities must aggressively pursue compliance because environmental laws often impose strict liability for violations; therefore, an honest mistake is no defense. Radioactive waste management is constantly under the public microscope, particularly those facilities that handle high-level radioactive waste. The Savannah River Site has effectively met the challenges of regulatory compliance in its HLRW facilities and plans are being formulated to meet future regulatory requirements as well. Understanding, aggressively achieving, and clearly demonstrating compliance is essential for the continued operations of radioactive waste management facilities. This paper examines how HLRW facilities are impacted by regulatory requirements and how compliance in this difficult area is achieved and maintained

  3. Compliance. Regulatory policy P-211

    International Nuclear Information System (INIS)

    2001-05-01

    This regulatory policy describes the basic principles and directives for establishing and conducting the Canadian Nuclear Safety Commission (CNSC) Compliance Program. The program is aimed at securing compliance by regulated persons with regulatory requirements made under the Nuclear Safety and Control Act ('the Act'). The policy applies to persons who are regulated by the CNSC through the Act, regulations and licences, as well as by decisions and orders made under the Act. The policy applies to officers and employees of the CNSC, and its authorized representatives or agents, who are involved in developing and carrying out compliance activities. Compliance, in the context of this policy, means conformity by regulated persons with the legally binding requirements of the Act, and the CNSC regulations, licences, decisions, and orders made under the Act. Compliance activities are CNSC measures of promotion, verification and enforcement aimed at securing compliance by regulated person with the applicable legally binding requirements. (author)

  4. Mobile Source Emissions Regulatory Compliance Data Inventory

    Data.gov (United States)

    U.S. Environmental Protection Agency — The Mobile Source Emissions Regulatory Compliance Data Inventory data asset contains measured summary compliance information on light-duty, heavy-duty, and non-road...

  5. State regulatory issues in acid rain compliance

    International Nuclear Information System (INIS)

    Solomon, B.D.; Brick, S.

    1992-01-01

    This article discusses the results of a US EPA workshop for state regulators and commission staff on acid rain compliance concerns. The topics of the article include the results of market-based emissions control, how emissions trading is expected to reduce emissions, public utility commissions approval of compliance plans, the purposes of the workshop, market information, accounting issues, regulatory process and utility planning, multi-state compliance planning, and relationship to other compliance issues

  6. 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

  7. Architecture-based regulatory compliance argumentation

    DEFF Research Database (Denmark)

    Mihaylov, Boyan; Onea, Lucian; Hansen, Klaus Marius

    2016-01-01

    Standards and regulations are difficult to understand and map to software, which makes compliance with them challenging to argue for software products and development process. This is problematic since lack of compliance may lead to issues with security, safety, and even to economic sanctions....... An increasing number of applications (for example in healthcare) are expected to have to live up to regulatory requirements in the future, which will lead to more software development projects having to deal with such requirements. We present an approach that models regulations such that compliance arguments...... the approach on the migration of the telemedicine platform Net4Care to the cloud, where certain regulations (for example privacy) should be concerned. The approach has the potential to support simpler compliance argumentation with the eventual promise of safer and more secure applications....

  8. The waste isolation pilot plant regulatory compliance program

    International Nuclear Information System (INIS)

    Mewhinney, J.A.; Kehrman, R.F.

    1996-01-01

    The passage of the WIPP Land Withdrawal Act of 1992 (LWA) marked a turning point for the Waste Isolation Pilot Plant (WIPP) program. It established a Congressional mandate to open the WIPP in as short a time as possible, thereby initiating the process of addressing this nation's transuranic (TRU) waste problem. The DOE responded to the LWA by shifting the priority at the WIPP from scientific investigations to regulatory compliance and the completion of prerequisites for the initiation of operations. Regulatory compliance activities have taken four main focuses: (1) preparing regulatory submittals; (2) aggressive schedules; (3) regulator interface; and (4) public interactions

  9. 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

  10. 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

  11. 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

  12. Costs of regulatory compliance: categories and estimating techniques

    International Nuclear Information System (INIS)

    Schulte, S.C.; McDonald, C.L.; Wood, M.T.; Cole, R.M.; Hauschulz, K.

    1978-10-01

    Use of the categorization scheme and cost estimating approaches presented in this report can make cost estimates of regulation required compliance activities of value to policy makers. The report describes a uniform assessment framework that when used would assure that cost studies are generated on an equivalent basis. Such normalization would make comparisons of different compliance activity cost estimates more meaningful, thus enabling the relative merits of different regulatory options to be more effectively judged. The framework establishes uniform cost reporting accounts and cost estimating approaches for use in assessing the costs of complying with regulatory actions. The framework was specifically developed for use in a current study at Pacific Northwest Laboratory. However, use of the procedures for other applications is also appropriate

  13. 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

  14. Assessment of compliance with regulatory requirements for a best estimate methodology for evaluation of ECCS

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Un Chul; Jang, Jin Wook; Lim, Ho Gon; Jeong, Ik [Seoul National Univ., Seoul (Korea, Republic of); Sim, Suk Ku [Korea Atomic Energy Research Institute, Taejon (Korea, Republic of)

    2000-03-15

    Best estimate methodology for evaluation of ECCS proposed by KEPCO(KREM) os using thermal-hydraulic best-estimate code and the topical report for the methodology is described that it meets the regulatory requirement of USNRC regulatory guide. In this research the assessment of compliance with regulatory guide. In this research the assessment of compliance with regulatory requirements for the methodology is performed. The state of licensing procedure of other countries and best-estimate evaluation methodologies of Europe is also investigated, The applicability of models and propriety of procedure of uncertainty analysis of KREM are appraised and compliance with USNRC regulatory guide is assessed.

  15. Regulatory Compliance in Multi-Tier Supplier Networks

    Science.gov (United States)

    Goossen, Emray R.; Buster, Duke A.

    2014-01-01

    Over the years, avionics systems have increased in complexity to the point where 1st tier suppliers to an aircraft OEM find it financially beneficial to outsource designs of subsystems to 2nd tier and at times to 3rd tier suppliers. Combined with challenging schedule and budgetary pressures, the environment in which safety-critical systems are being developed introduces new hurdles for regulatory agencies and industry. This new environment of both complex systems and tiered development has raised concerns in the ability of the designers to ensure safety considerations are fully addressed throughout the tier levels. This has also raised questions about the sufficiency of current regulatory guidance to ensure: proper flow down of safety awareness, avionics application understanding at the lower tiers, OEM and 1st tier oversight practices, and capabilities of lower tier suppliers. Therefore, NASA established a research project to address Regulatory Compliance in a Multi-tier Supplier Network. This research was divided into three major study efforts: 1. Describe Modern Multi-tier Avionics Development 2. Identify Current Issues in Achieving Safety and Regulatory Compliance 3. Short-term/Long-term Recommendations Toward Higher Assurance Confidence This report presents our findings of the risks, weaknesses, and our recommendations. It also includes a collection of industry-identified risks, an assessment of guideline weaknesses related to multi-tier development of complex avionics systems, and a postulation of potential modifications to guidelines to close the identified risks and weaknesses.

  16. Framing of information on the use of public finances, regulatory fit of recipients and tax compliance

    Science.gov (United States)

    Holler, Marianne; Hoelzl, Erik; Kirchler, Erich; Leder, Susanne; Mannetti, Lucia

    2010-01-01

    Information campaigns to increase tax compliance could be framed in different ways. They can either highlight the potential gains when tax compliance is high, or the potential losses when compliance is low. According to regulatory focus theory, such framing should be most effective when it is congruent with the promotion or prevention focus of its recipients. Two studies confirmed the hypothesized interaction effects between recipients' regulatory focus and framing of information campaigns, with tax compliance being highest under conditions of regulatory fit. To address taxpayers effectively, information campaigns by tax authorities should consider the positive and negative framing of information, and the moderating effect of recipients' regulatory focus. PMID:20495689

  17. Framing of information on the use of public finances, regulatory fit of recipients and tax compliance.

    Science.gov (United States)

    Holler, Marianne; Hoelzl, Erik; Kirchler, Erich; Leder, Susanne; Mannetti, Lucia

    2008-08-01

    Information campaigns to increase tax compliance could be framed in different ways. They can either highlight the potential gains when tax compliance is high, or the potential losses when compliance is low. According to regulatory focus theory, such framing should be most effective when it is congruent with the promotion or prevention focus of its recipients. Two studies confirmed the hypothesized interaction effects between recipients' regulatory focus and framing of information campaigns, with tax compliance being highest under conditions of regulatory fit. To address taxpayers effectively, information campaigns by tax authorities should consider the positive and negative framing of information, and the moderating effect of recipients' regulatory focus.

  18. 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.

  19. 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

  20. 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

  1. 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

  2. Poster — Thur Eve — 50: Common Regulatory Non-Compliances and How to Avoid Them

    Energy Technology Data Exchange (ETDEWEB)

    Heimann, M.

    2014-08-15

    The Accelerators and Class II Facilities Division (ACFD) of the Canadian Nuclear Safety Commission (CNSC), is responsible for the oversight of radiotherapy facilities containing Class II prescribed equipment in Canada. Over the past several years, ACFD has been performing compliance inspections of Class II nuclear facilities across the country (medical and otherwise), and in that time, has issued several hundred corrective actions to licensees due to non-compliance with regulatory requirements. Recently, a study was done to determine the most common regulatory non-compliances. The purpose of this poster presentation is to disseminate information to the licensee community about the nature of these non-compliances, and how they can be avoided by licensees in the future.

  3. 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

  4. Use of acceptable knowledge to demonstrate TRAMPAC compliance

    International Nuclear Information System (INIS)

    Whitworth, Julia; Becker, Blair; Guerin, David; Shokes, Tamara

    2004-01-01

    Recently, Los Alamos National Laboratory-Carlsbad Operations (LANL-CO) has supported the Central Characterization Project (CCP) managed by the U.S. Department of Energy (DOE) in the shipment of transuranic (TRU) waste from various small-quantity TRU waste generators to hub sites or other DOE sites in TRUPACT-II shipping containers. This support has involved using acceptable knowledge (AK) to demonstrate compliance with various requirements of Revision 19 of the TRUPACT-II Authorized Methods of Payload Compliance (TRAMPAC). LANL-CO has worked to facilitate TRUPACT-II shipments from the University of Missouri Research Reactor (MURR) and Lovelace Respiratory Research Institute (LRRI) to Argonne National Laboratory-East (ANL-E) and Los Alamos National Laboratory (LANL), respectively. The latter two sites have TRU waste certification programs approved to ship waste to the Waste Isolation Pilot Plant (WIPP) for disposal. In each case, AK was used to satisfy the necessary information to ship the waste to other DOE facilities. For the purposes of intersite shipment, AK provided data to WIPP Waste Information System (WWIS) transportation modules to ensure that required information was obtained prior to TRUPACT-II shipments. The WWIS modules were used for the intersite shipments, not to enter certification data into WWIS, but rather to take advantage of a validated system to ensure that the containers to be shipped were compliant with TRAMPAC requirements, particularly in the evaluation of quantitative criteria. LANL-CO also assisted with a TRAMPAC compliance demonstration for homogeneous waste containers shipped in TRUPACT-II containers from ANL-E to Idaho National Engineering and Environmental Laboratory (INEEL) for the purpose of core sampling. The basis for the TRAMPAC compliance determinations was AK regarding radiological composition, chemical composition, TRU waste container packaging, and absence of prohibited items. Also, even in the case where AK is not used to

  5. 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

  6. 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

  7. Perspective on demonstrations of compliance for high-level waste disposal

    International Nuclear Information System (INIS)

    Kocher, D.C.; Smith, E.D.; O'Kelly, G.D.; Sjoreen, A.L.

    1984-01-01

    This paper discusses a perspective which we have developed on the problem of demonstrating compliance of high-level waste repositories with system performance standards. Our viewpoint arises from two primary concerns - first, that the US Environmental Protection Agency's proposed environmental standard for high-level waste disposal appears to require demonstrations of compliance which are incompatible with scientific knowledge, and, second, that the federal agencies involved in the licensing process may not appreciate fully the extent of unquantifiable and uresolvable uncertainty in repository performance-assessment models. We propose a general approach to demonstrations of compliance which we feel is compatible with the kinds of technical information that will be available for judging repository performance. Our approach emphasizes the importance of investigation alternative conceptual models and lines of reasoning in evaluating repository performance and the importance of subjective scientific judgment in the desision-making process. 24 references, 1 figure

  8. 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

  9. MO-AB-201-03: The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections

    Energy Technology Data Exchange (ETDEWEB)

    Kroger, L. [University of California Davis (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

  10. MO-AB-201-03: The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections

    International Nuclear Information System (INIS)

    Kroger, 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

  11. 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...

  12. 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

  13. 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.

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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.

  19. 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

  20. 40 CFR 63.10420 - How do I demonstrate continuous compliance with the management practice requirements?

    Science.gov (United States)

    2010-07-01

    ... compliance with the management practice requirements? 63.10420 Section 63.10420 Protection of Environment... continuous compliance with the management practice requirements? For each sterilization unit not equipped with an air pollution control device, you must demonstrate continuous compliance with the management...

  1. Idaho CERCLA Disposal Facility Complex Compliance Demonstration for DOE Order 435.1

    Energy Technology Data Exchange (ETDEWEB)

    J. Simonds

    2006-09-01

    This compliance demonstration document provides an analysis of the Idaho CERCLA Disposal Facility (ICDF) Complex compliance with DOE Order 435.1. The ICDF Complex includes the disposal facility (landfill), evaporation pond, admin facility, weigh scale, decon building, treatment systems, and various staging/storage areas. These facilities were designed and are being constructed to be compliant with DOE Order 435.1, Resource Conservation and Recovery Act Subtitle C, and Toxic Substances Control Act polychlorinated biphenyl design and construction standards. The ICDF Complex is designated as the central Idaho National Laboratory (INL) facilityyy for the receipt, staging/storage, treatment, and disposal of INL Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) waste streams. This compliance demonstration document discusses the conceptual site model for the ICDF Complex area. Within this conceptual site model, the selection of the area for the ICDF Complex is discussed. Also, the subsurface stratigraphy in the ICDF Complex area is discussed along with the existing contamination beneath the ICDF Complex area. The designs for the various ICDF Complex facilities are also included in this compliance demonstration document. These design discussions are a summary of the design as presented in the Remedial Design/Construction Work Plans for the ICDF landfill and evaporation pond and the Staging, Storage, Sizing, and Treatment Facility. Each of the major facilities or systems is described including the design criteria.

  2. Guidance manual for conducting technology demonstration activities

    International Nuclear Information System (INIS)

    Jolley, R.L.; Morris, M.I.; Singh, S.P.N.

    1991-12-01

    This demonstration guidance manual has been prepared to assist Martin Marietta Energy Systems, Inc. (Energy Systems), staff in conducting demonstrations. It is prepared in checklist style to facilitate its use and assumes that Energy Systems personnel have project management responsibility. In addition to a detailed step-by-step listing of procedural considerations, a general checklist, logic flow diagram, and several examples of necessary plans are included to assist the user in developing an understanding of the many complex activities required to manage technology demonstrations. Demonstrations are pilot-scale applications of often innovative technologies to determine the commercial viability of the technologies to perform their designed function. Demonstrations are generally conducted on well-defined problems for which existing technologies or processes are less than satisfactory in terms of effectiveness, cost, and/or regulatory compliance. Critically important issues in demonstration management include, but are not limited to, such factors as communications with line and matrix management and with the US Department of Energy (DOE) and Energy Systems staff responsible for management oversight, budgetary and schedule requirements, regulatory compliance, and safety

  3. Guidance manual for conducting technology demonstration activities

    Energy Technology Data Exchange (ETDEWEB)

    Jolley, Robert L.; Morris, Michael I.; Singh, Suman P.N.

    1991-12-01

    This demonstration guidance manual has been prepared to assist Martin Marietta Energy Systems, Inc. (Energy Systems), staff in conducting demonstrations. It is prepared in checklist style to facilitate its use and assumes that Energy Systems personnel have project management responsibility. In addition to a detailed step-by-step listing of procedural considerations, a general checklist, logic flow diagram, and several examples of necessary plans are included to assist the user in developing an understanding of the many complex activities required to manage technology demonstrations. Demonstrations are pilot-scale applications of often innovative technologies to determine the commercial viability of the technologies to perform their designed function. Demonstrations are generally conducted on well-defined problems for which existing technologies or processes are less than satisfactory in terms of effectiveness, cost, and/or regulatory compliance. Critically important issues in demonstration management include, but are not limited to, such factors as communications with line and matrix management and with the US Department of Energy (DOE) and Energy Systems staff responsible for management oversight, budgetary and schedule requirements, regulatory compliance, and safety.

  4. 40 CFR 59.506 - How do I demonstrate compliance if I manufacture multi-component kits?

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 5 2010-07-01 2010-07-01 false How do I demonstrate compliance if I manufacture multi-component kits? 59.506 Section 59.506 Protection of Environment ENVIRONMENTAL PROTECTION... § 59.506 How do I demonstrate compliance if I manufacture multi-component kits? (a) If you manufacture...

  5. 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...

  6. Regulatory requirements of the integrated technology demonstration program, Savannah River Site (U)

    International Nuclear Information System (INIS)

    Bergren, C.L.

    1992-01-01

    The integrated demonstration program at the Savannah River Site (SRS) involves demonstration, testing and evaluation of new characterization, monitoring, drilling and remediation technologies for soils and groundwater impacted by organic solvent contamination. The regulatory success of the demonstration program has developed as a result of open communications between the regulators and the technical teams involved. This open dialogue is an attempt to allow timely completion of applied environmental restoration demonstrations while meeting all applicable regulatory requirements. Simultaneous processing of multiple regulatory documents (satisfying RCRA, CERCLA, NEPA and various state regulations) has streamlined the overall permitting process. Public involvement is achieved as various regulatory documents are advertised for public comment consistent with the site's community relations plan. The SRS integrated demonstration has been permitted and endorsed by regulatory agencies, including the Environmental Protection Agency (EPA) and the South Carolina Department of Health and Environmental Control. EPA headquarters and regional offices are involved in DOE's integrated Demonstration Program. This relationship allows for rapid regulatory acceptance while reducing federal funding and time requirements. (author)

  7. 40 CFR 63.7940 - By what date must I conduct performance tests or other initial compliance demonstrations?

    Science.gov (United States)

    2010-07-01

    ... compliance is not demonstrated using a performance test or design evaluation, you must demonstrate initial... performance tests or other initial compliance demonstrations? 63.7940 Section 63.7940 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL EMISSION STANDARDS...

  8. International trends in regulatory principles, criteria and compliance

    International Nuclear Information System (INIS)

    Bragg, K.A.

    1996-01-01

    This paper is intended to summarize recent international developments on regulatory principles, criteria and related compliance issues. It focuses on the work within the IAEA undertaken by the Working Group on Principles and Criteria for Radioactive Waste Disposal and Within the NEA by another Working Group on the Regulatory Aspects of Future Human Actions at Radioactive Waste Disposal Sites. Both groups have been chaired by the author. The IAEA working group members are drawn from regulatory bodies and implementing organizations. Thus a balance is maintained between various points of view on topics such as the theory of radiation protection and its practical application. The group has a very flexible mandate and in practice the topics it chooses to address, and the priorities which are assigned to them, are selected by the group itself, under the direction of the new Waste Safety Standard Advisory Committee (WASSAC). The IAEA group is concerned with examining areas of importance to safety principles for waste disposal on which no consensus yet exists and with exploring new ideas and concepts. Because of the inherent uncertainty in such a process, no targets or schedules have been set for the group to produce reports, although it is recognised that if consensus is reached on an important issue then it should be documented. In contrast, the Radioactive Waste Safety Standards (RADWASS) programme of the IAEA has the aim of documenting the existing areas of consensus in a structured way and of doing so against preestablished timescales. The group meets annually and has had 5 meetings to date. The following sections summarize the main accomplishments of the group and indicate the status of some work that is well developed but has not yet been published. (author)

  9. 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

  10. 40 CFR 63.5991 - By what date must I conduct an initial compliance demonstration or performance test?

    Science.gov (United States)

    2010-07-01

    ... compliance demonstration or performance test? 63.5991 Section 63.5991 Protection of Environment ENVIRONMENTAL... POLLUTANTS FOR SOURCE CATEGORIES National Emissions Standards for Hazardous Air Pollutants: Rubber Tire... initial compliance demonstration or performance test? (a) If you have a new or reconstructed affected...

  11. 40 CFR 63.1585 - How does an industrial POTW treatment plant demonstrate compliance?

    Science.gov (United States)

    2010-07-01

    ... Works Industrial Potw Treatment Plant Description and Requirements § 63.1585 How does an industrial POTW treatment plant demonstrate compliance? (a) An existing industrial POTW treatment plant demonstrates... §§ 63.1586 through 63.1590. Non-industrial POTW Treatment Plant Requirements ...

  12. 40 CFR 63.7335 - How do I demonstrate continuous compliance with the operation and maintenance requirements that...

    Science.gov (United States)

    2010-07-01

    ... corrective action is completed. (c) To demonstrate continuous compliance with the operation and maintenance... compliance with the operation and maintenance requirements that apply to me? 63.7335 Section 63.7335... maintenance requirements that apply to me? (a) For each by-product coke oven battery, you must demonstrate...

  13. 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...

  14. 40 CFR 63.7826 - How do I demonstrate initial compliance with the operation and maintenance requirements that...

    Science.gov (United States)

    2010-07-01

    ... preventative maintenance schedule and, as applicable, detailed descriptions of the corrective action procedures... compliance with the operation and maintenance requirements that apply to me? 63.7826 Section 63.7826... Compliance Requirements § 63.7826 How do I demonstrate initial compliance with the operation and maintenance...

  15. 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

  16. 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

  17. 40 CFR 63.6006 - How do I demonstrate continuous compliance with the emission limits for tire cord production...

    Science.gov (United States)

    2010-07-01

    ... compliance with the emission limits for tire cord production affected sources? 63.6006 Section 63.6006... Hazardous Air Pollutants: Rubber Tire Manufacturing Continuous Compliance Requirements for Tire Cord... tire cord production affected sources? (a) You must demonstrate continuous compliance with each...

  18. Regulatory and extra-regulatory testing to demonstrate radioactive material packaging safety

    International Nuclear Information System (INIS)

    Ammerman, D.J.

    1997-01-01

    Packages for the transportation of radioactive material must meet performance criteria to assure safety and environmental protection. The stringency of the performance criteria is based on the degree of hazard of the material being transported. Type B packages are used for transporting large quantities of radioisotopes (in terms of A 2 quantities). These packages have the most stringent performance criteria. Material with less than an A 2 quantity are transported in Type A packages. These packages have less stringent performance criteria. Transportation of LSA and SCO materials must be in open-quotes strong-tightclose quotes packages. The performance requirements for the latter packages are even less stringent. All of these package types provide a high level of safety for the material being transported. In this paper, regulatory tests that are used to demonstrate this safety will be described. The responses of various packages to these tests will be shown. In addition, the response of packages to extra-regulatory tests will be discussed. The results of these tests will be used to demonstrate the high level of safety provided to workers, the public, and the environment by packages used for the transportation of radioactive material

  19. 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)

  20. 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

  1. 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

  2. 40 CFR 63.6004 - How do I demonstrate continuous compliance with the emission limits for tire production affected...

    Science.gov (United States)

    2010-07-01

    ... compliance with the emission limits for tire production affected sources? 63.6004 Section 63.6004 Protection... Pollutants: Rubber Tire Manufacturing Continuous Compliance Requirements for Tire Production Affected Sources § 63.6004 How do I demonstrate continuous compliance with the emission limits for tire production...

  3. 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)

  4. 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.

  5. Idaho CERCLA Disposal Facility Complex Compliance Demonstration for DOE Order 435.1

    Energy Technology Data Exchange (ETDEWEB)

    Simonds, J.

    2007-11-06

    This compliance demonstration document provides an analysis of the Idaho CERCLA Disposal Facility (ICDF) Complex compliance with DOE Order 435.1. The ICDF Complex includes the disposal facility (landfill), evaporation pond, administration facility, weigh scale, and various staging/storage areas. These facilities were designed and constructed to be compliant with DOE Order 435.1, Resource Conservation and Recovery act Subtitle C, and Toxic Substances Control Act polychlorinated biphenyl design and construction standards. The ICDF Complex is designated as the Idaho National Laboratory (INL) facility for the receipt, staging/storage, treatment, and disposal of INL Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) waste streams.

  6. Guidance: Demonstrating Compliance with the Land Disposal Restrictions (LDR) Alternative Soil Treatment Standards

    Science.gov (United States)

    This guidance provides suggestions and perspectives on how members of the regulated community, states, and the public can demonstrate compliance with the alternative treatment standards for certain contaminated soils that will be land disposed.

  7. 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

  8. 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.

  9. 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.

  10. Regulatory analysis of the Underground Storage Tank-Integrated Demonstration Program

    International Nuclear Information System (INIS)

    Smith, E.H.

    1992-01-01

    The Underground Storage Tank-Integrated Demonstration (UST-ID) Program has been developed to identify, demonstrate, test, and evaluate technologies that will provide alternatives to the current underground storage tank remediation program. The UST-ID Program is a national program that consists of five participating US Department of Energy (DOE) sites where technologies can be developed an ultimately demonstrated. Once these technologies are demonstrated, the UST-ID Program will transfer the developed technology system to industry (governmental or industrial) for application or back to Research and Development for further evaluation and modification, as necessary. In order to ensure that the UST-ID Program proceeds without interruption, it will be necessary to identify regulatory requirements along with associated permitting and notification requirements early in the technology development process. This document serves as a baseline for identifying certain federal and state regulatory requirements that may impact the UST-ID Program and the demonstration of any identified technologies

  11. 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.

  12. A perspective on demonstrating compliance with standards for disposal of high-level radioactive wastes

    International Nuclear Information System (INIS)

    Kocher, D.C.; Smith, E.D.; O'Kelley, G.D.; Sjoreen, A.L.

    1985-01-01

    A perspective which the authors have developed on the problem of demonstrating that geologic repositories for the disposal of high-level radioactive wastes will comply with system performance standards is discussed. Their viewpoint arises from a concern that the U.S. Environmental Protection Agency's proposed environmental standard for high-level waste disposal appears to require demonstrations of compliance which are incompatible with scientific knowledge; i.e., the standard does not take into account the likely importance of unquantifiable and unresolvable uncertainty in repository performance-assessment models. A general approach to demonstrations of compliance is proposed which is thought to be compatible with the kinds of technical information that will be available for judging long-term repository performance. The authors' approach emphasizes the importance of investigating alternative conceptual models and lines of reasoning in evaluating repository performance and the importance of subjective scientific judgment in the decision-making process. (Auth.)

  13. 40 CFR 63.5885 - How do I calculate percent reduction to demonstrate compliance for continuous lamination/casting...

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 12 2010-07-01 2010-07-01 true How do I calculate percent reduction to... Pollutants: Reinforced Plastic Composites Production Testing and Initial Compliance Requirements § 63.5885 How do I calculate percent reduction to demonstrate compliance for continuous lamination/casting...

  14. 40 CFR 63.9915 - What test methods and other procedures must I use to demonstrate initial compliance with dioxin...

    Science.gov (United States)

    2010-07-01

    ... must I use to demonstrate initial compliance with dioxin/furan emission limits? 63.9915 Section 63.9915....9915 What test methods and other procedures must I use to demonstrate initial compliance with dioxin... limit for dioxins/furans in Table 1 to this subpart, you must follow the test methods and procedures...

  15. Industrial Fuel Gas Demonstration Plant Program: environmental permit compliance plan

    Energy Technology Data Exchange (ETDEWEB)

    Bodamer, Jr., James W.; Bocchino, Robert M.

    1979-11-01

    This Environmental Permit Compliance Plan is intended to assist the Memphis Light, Gas and Water Division in acquiring the necessary environmental permits for their proposed Industrial Fuel Gas Demonstration Plant in a time frame consistent with the construction schedule. Permits included are those required for installation and/or operation of gaseous, liquid and solid waste sources and disposal areas. Only those permits presently established by final regulations are described. The compliance plan describes procedures for obtaining each permit from identified federal, state and local agencies. The information needed for the permit application is presented, and the stepwise procedure to follow when filing the permit application is described. Information given in this plan was obtained by reviewing applicable laws and regulations and from telephone conversations with agency personnel on the federal, state and local levels. This Plan also presents a recommended schedule for beginning the work necessary to obtain the required environmental permits in order to begin dredging operations in October, 1980 and construction of the plant in September, 1981. Activity for several key permits should begin as soon as possible.

  16. 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)

  17. 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.

  18. 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

  19. 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.

  20. 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

  1. 40 CFR 63.5996 - How do I demonstrate initial compliance with the emission limits for tire production affected...

    Science.gov (United States)

    2010-07-01

    ... with the emission limits for tire production affected sources? 63.5996 Section 63.5996 Protection of... Pollutants: Rubber Tire Manufacturing Testing and Initial Compliance Requirements for Tire Production Affected Sources § 63.5996 How do I demonstrate initial compliance with the emission limits for tire...

  2. 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

  3. 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...

  4. 40 CFR 63.5999 - How do I demonstrate initial compliance with the emission limits for tire cord production...

    Science.gov (United States)

    2010-07-01

    ... with the emission limits for tire cord production affected sources? 63.5999 Section 63.5999 Protection... Pollutants: Rubber Tire Manufacturing Testing and Initial Compliance Requirements for Tire Cord Production Affected Sources § 63.5999 How do I demonstrate initial compliance with the emission limits for tire cord...

  5. Analyses to demonstrate the thermal performance of the CASTOR KN12

    International Nuclear Information System (INIS)

    Diersch, R.; Weiss, M.; Tso, C.F.; Powell, D.; Choy, B.I.; Lee, H.Y.

    2004-01-01

    The CASTOR registered KN-12 is a new cask design of GNB for dry and wet transportation of up to 12 PWR spent nuclear fuel assemblies in Korea. It complies with the requirements of 10 CFR 71 [1] and IAEA ST-1 [2] for TYPE B(U)F packages. It received its transport license from the Korean Competent Authority KINS in July 2002 and is now in use in South Korea. Demonstration of the cask's compliance with the regulatory requirements in the area of thermal performance has been carried out by a combination of testing carried out by Korea Atomic Energy Research Institute and analyses carried out by Arup. This paper describes the analyses to demonstrate the thermal performance of the cask and compliance with regulatory requirements under normal and hypothetical accident conditions of transport. Other aspects of the design of the CASTOR registered KN12 are presented in other papers at this conference

  6. 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

  7. 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

  8. 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.

  9. Early Site Permit Demonstration Program: Regulatory criteria evaluation report

    International Nuclear Information System (INIS)

    1993-03-01

    The primary objective of the Early Site Plan Demonstration Program (ESPDP) is to demonstrate successfully the use of 10CFR52 to obtain ESPs for one or more US sites for one (or more) ALWR nuclear power plants. It is anticipated that preparation of the ESP application and interaction with NRC during the application review process will result not only in an ESP for the applicant(s) but also in the development of criteria and definition of processes, setting the precedent that facilitates ESPs for subsequent ESP applications. Because siting regulatory processes and acceptance criteria are contained in over 100 separate documents, comprehensive licensing and technical reviews were performed to establish whether the requirements and documentation are self-consistent, whether the acceptance criteria are sufficiently well-defined and clear, and whether the licensing process leading to the issuance of an ESP is unambiguously specified. This document provides appendices A and B of this report. Appendix A contains a list of regulations, regulatory guidance, and acceptance criteria; Appendix B contains a cross-reference index of siting-related documentation

  10. 76 FR 24831 - Site-Specific Analyses for Demonstrating Compliance With Subpart C Performance Objectives

    Science.gov (United States)

    2011-05-03

    ...-level radioactive waste disposal facilities to conduct site-specific analyses to demonstrate compliance... public health and safety, these amendments would enhance the safe disposal of low-level radioactive waste... would be to enhance the safe disposal of low-level radioactive waste. The NRC is also proposing...

  11. Uncertainties and demonstration of compliance with numerical risk standards

    International Nuclear Information System (INIS)

    Preyssl, C.; Cullingford, M.C.

    1987-01-01

    When dealing with numerical results of a probabilistic risk analysis performed for a complex system, such as a nuclear power plant, one major objective may be to deal with the problem of compliance or non-compliance with a prefixed risk standard. The uncertainties in the risk results associated with the consequences and their probabilities of occurrence may be considered by representing the risk as a risk band. Studying the area and distance between the upper and lower bound of the risk band provides consistent information on the uncertainties in terms of risk, not by means of scalars only but also by real functions. Criteria can be defined for determining compliance with a numerical risk standard, and the 'weighting functional' method, representing a possible tool for testing compliance of risk results, is introduced. By shifting the upper confidence bound due to redefinition, part of the risk band may exceed the standard without changing the underlying results. Using the concept described it is possible to determine the amount of risk, i.e. uncertainty, exceeding the standard. The mathematical treatment of uncertainties therefore allows probabilistic risk assessment results to be compared. A realistic example illustrates the method. (author)

  12. 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.

  13. 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)

  14. 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

  15. Performance demonstration program plan for RCRA constituent analysis of solidified wastes

    International Nuclear Information System (INIS)

    1995-06-01

    Performance Demonstration Programs (PDPS) are designed to help ensure compliance with the Quality Assurance Objectives (QAOs) for the Waste Isolation Pilot Plant (WIPP). The PDPs are intended for use by the Department of Energy (DOE) Carlsbad Area Office (CAO) to assess and approve the laboratories and other measurement facilities supplying services for the characterization of WIPP TRU waste. The PDPs may also be used by CAO in qualifying laboratories proposing to supply additional analytical services that are required for other than waste characterization, such as WIPP site operations. The purpose of this PDP is to test laboratory performance for the analysis of solidified waste samples for TRU waste characterization. This performance will be demonstrated by the successful analysis of blind audit samples of simulated, solidified TRU waste according to the criteria established in this plan. Blind audit samples (hereinafter referred to as PDP samples) will be used as an independent means to assess laboratory performance regarding compliance with the QAOs. The concentration of analytes in the PDP samples will address levels of regulatory concern and will encompass the range of concentrations anticipated in actual waste characterization samples. Analyses that are required by the WIPP to demonstrate compliance with various regulatory requirements and which are included in the PDP must be performed by laboratories that demonstrate acceptable performance in the PDP. These analyses are referred to as WIPP analyses and the samples on which they are performed are referred to as WIPP samples for the balance of this document

  16. 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.

  17. An evaluation of the effectiveness of the EPA comply code to demonstrate compliance with radionuclide emission standards at three manufacturing facilities

    International Nuclear Information System (INIS)

    Smith, L.R.; Laferriere, J.R.; Nagy, J.W.

    1991-01-01

    Measurements of airborne radionuclide emissions and associated environmental concentrations were made at, and in the vicinity of, two urban and one suburban facility where radiolabeled chemicals for biomedical research and radiopharmaceuticals are manufactured. Emission, environmental and meteorological measurements were used in the EPA COMPLY code and in environmental assessment models developed specifically for these sites to compare their ability to predict off-site measurements. The models and code were then used to determine potential dose to hypothetical maximally exposed receptors and the ability of these methods to demonstrate whether these facilities comply with proposed radionuclide emission standards assessed. In no case did the models and code seriously underestimate off-site impacts. However, for certain radionuclides and chemical forms, the EPA COMPLY code was found to overestimate off-site impacts by such a large factor as to render its value questionable for determining regulatory compliance. Recommendations are offered for changing the code to enable it to be more serviceable to radionuclide users and regulators

  18. 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

  19. 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

  20. 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

  1. 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

  2. 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.

  3. 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

  4. Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study

    Directory of Open Access Journals (Sweden)

    Carla Pires

    Full Text Available CONTEXT AND OBJECTIVES: Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1 to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2 to identify potential safety issues for patients. DESIGN AND SETTING: Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon. METHODS: A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose. RESULTS: A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. CONCLUSION: Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines.

  5. A process for ensuring regulatory compliance at the INEL`s buried waste integrated demonstrations

    Energy Technology Data Exchange (ETDEWEB)

    Cannon, P.G.; Watson, L.R.; Blacker, P.B. [EG and G Idaho, Inc., Idaho Falls, ID (United States). Idaho National Engineering Lab.

    1993-03-01

    The Buried Waste Integrated Demonstration Program is funded by the Department of Energy Office of Technology Development. The mission of this Integrated Demonstration is to identify, evaluate, and demonstrate a suite of innovative technologies for the remediation of radioactive and hazardous waste buried throughout the DOE complex between 1950 and 1970. The program approach to development of a long-range strategy for improving buried waste remediation capabilities is to combine systems analysis with already identified remediation needs for DOE complex buried waste. The systems analysis effort has produced several configuration options (a top-level block diagram of a cradle-to-grave remediation system) capable of remediating the transuranic-contaminated waste pits and trenches at the Idaho National Engineering Laboratory. Technologies for demonstration are selected using three criteria: (a) the ability to satisfy a specific buried waste need, (b) the ability to satisfy functional and operational requirements defined for functional sub-elements in a configuration option, and (c) performance against Comprehensive Environmental Restoration and Compensation Liability Act selection criteria, such as effectiveness, implementability, and cost. Early demonstrations experienced problems with missed requirements, prompting the Buried Waste Integrated Demonstration Program Office to organize a Corrective Action Team to identify the cause and recommend corrective actions. The result of this team effort is the focus of this paper.

  6. 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)

  7. 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...

  8. 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

  9. 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

  10. 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.

  11. 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)

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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.

  17. 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

  18. 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

  19. 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

  20. 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

  1. 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

  2. 40 CFR 60.4340 - How do I demonstrate continuous compliance for NOX if I do not use water or steam injection?

    Science.gov (United States)

    2010-07-01

    ... compliance for NOX if I do not use water or steam injection? 60.4340 Section 60.4340 Protection of....4340 How do I demonstrate continuous compliance for NOX if I do not use water or steam injection? (a) If you are not using water or steam injection to control NOX emissions, you must perform annual...

  3. 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.

  4. Performance demonstration program plan for analysis of simulated headspace gases

    International Nuclear Information System (INIS)

    1995-06-01

    The Performance Demonstration Program (PDP) for analysis of headspace gases will consist of regular distribution and analyses of test standards to evaluate the capability for analyzing VOCs, hydrogen, and methane in the headspace of transuranic (TRU) waste throughout the Department of Energy (DOE) complex. Each distribution is termed a PDP cycle. These evaluation cycles will provide an objective measure of the reliability of measurements performed for TRU waste characterization. Laboratory performance will be demonstrated by the successful analysis of blind audit samples of simulated TRU waste drum headspace gases according to the criteria set within the text of this Program Plan. Blind audit samples (hereinafter referred to as PDP samples) will be used as an independent means to assess laboratory performance regarding compliance with the QAPP QAOs. The concentration of analytes in the PDP samples will encompass the range of concentrations anticipated in actual waste characterization gas samples. Analyses which are required by the WIPP to demonstrate compliance with various regulatory requirements and which are included in the PDP must be performed by laboratories which have demonstrated acceptable performance in the PDP

  5. 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

  6. Proposed success demonstration criteria for the Department of Energy's waste reduction efforts

    International Nuclear Information System (INIS)

    Suffern, J.S.

    1990-01-01

    Seven proposed criteria for demonstration of success in waste reduction have been developed: reduced amount of hazardous waste, reduced waste management cost, improved regulatory compliance, reduced health risk, increased production efficiency, reduced accident risk, and improved public relations. A detailed description of each of the criteria is presented along with a discussion for each of the mechanisms for measurement, required commitments, strengths, and weaknesses. 2 refs

  7. Environment, safety and health, management and organization compliance assessment, West Valley Demonstration Program, West Valley, New York

    International Nuclear Information System (INIS)

    1989-08-01

    An Environment, Safety and Health ''Tiger Team'' Assessment was conducted at the West Valley Demonstration Project. The Tiger Team was chartered to conduct an onsite, independent assessment of WVDP's environment, safety and health (ES ampersand H) programs to assure compliance with applicable Federal and State laws, regulations, and standards, and Department of Energy Orders. The objective is to provide to the Secretary of Energy the following information: current ES ampersand H compliance status of each facility; specific noncompliance items; ''root causes'' for noncompliance items; evaluation of the adequacy of ES ampersand H organization and resources (DOE and contractor) and needed modifications; and where warranted, recommendations for addressing identified problem areas

  8. 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

  9. 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

  10. 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.

  11. 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 ...

  12. 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.

  13. Investigation of the feasibility of an international integrated demonstration: Joint demonstration of environmental cleanup technologies in Eastern Europe/former Soviet Union

    International Nuclear Information System (INIS)

    Hagood, M.C.; Stein, S.L.; Brouns, T.M.; McCabe, G.H.

    1993-01-01

    Eastern Europe (EE) and the former Soviet Union (FSU) republics have areas that are contaminated with radioactive and hazardous constituents. The Westinghouse Hanford Company is exploring the feasibility of establishing a collaborative effort with various US agencies to establish an International Integrated Demonstration (IID). Westinghouse manages the waste management and cleanup programs at the US Department of Energy's (DOE) Hanford Site. The purpose of the IID would be to (1) facilitate assistance to EE/FSU cleanup efforts, (2) provide hands-on management and operational assistance to EE/FSU countries, (3) provide a basis for evaluating opportunities for and establishing future collaborations, and (4) evaluate the applicability of US technologies to both US and EE/FSU cleanup efforts. The DOE's Integrated Demonstration Programs are currently providing the conduit for development and demonstration and transfer and deployment of innovative technologies to meet DOE's cleanup need for hazardous and radioactive wastes. The Integrated Demonstrations are focused on all facets of environmental restoration including characterization, remediation, monitoring, site closure, regulatory compliance, and regulatory and public acceptance. Innovative technologies are being tested and demonstrated at host sites across the country to provide the necessary performance data needed to deploy these technologies. The IID concept would be to conduct an Integrated Demonstration at one or more EE/FSU host sites

  14. 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.

  15. 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

  16. 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

  17. 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.

  18. 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.

  19. 40 CFR 63.5755 - How do I demonstrate compliance with the aluminum recreational boat surface coating spray gun...

    Science.gov (United States)

    2010-07-01

    ... the aluminum recreational boat surface coating spray gun cleaning work practice standards? 63.5755... surface coating spray gun cleaning work practice standards? You must demonstrate compliance with the aluminum coating spray gun cleaning work practice standards by meeting the requirements of paragraph (a) or...

  20. 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

  1. 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

  2. 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.

  3. 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...

  4. 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

  5. 40 CFR 63.5746 - How do I demonstrate compliance with the emission limits for aluminum wipedown solvents and...

    Science.gov (United States)

    2010-07-01

    ... Operations § 63.5746 How do I demonstrate compliance with the emission limits for aluminum wipedown solvents... per kilogram of material, or weight fraction) of each aluminum wipedown solvent and aluminum coating... of solids per liter of coating, or volume fraction) of each aluminum surface coating, including...

  6. 40 CFR 63.5737 - How do I demonstrate compliance with the resin and gel coat application equipment cleaning...

    Science.gov (United States)

    2010-07-01

    ... the resin and gel coat application equipment cleaning standards? 63.5737 Section 63.5737 Protection of... Pollutants for Boat Manufacturing Standards for Resin and Gel Coat Application Equipment Cleaning Operations § 63.5737 How do I demonstrate compliance with the resin and gel coat application equipment cleaning...

  7. Regulatory requirements for demonstration of the achieved safety level at the Mochovce NPP before commissioning

    International Nuclear Information System (INIS)

    Lipar, M.

    1997-01-01

    A review of regulatory requirements for demonstration of the achieved safety level at the Mochovce NPP before commissioning is given. It contains licensing steps in Slovakia during commissioning; Status and methodology of Mochovce safety analysis report; Mochovce NPP safety enhancement program; Regulatory body policy towards Mochovce NPP safety enhancement; Recent development in Mochovce pre-operational safety enhancement program review and assessment process; Licensing steps in Slovakia during commissioning

  8. 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

  9. 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...

  10. Is it possible to demonstrate compliance with the regulations for high-level-waste repositories?

    International Nuclear Information System (INIS)

    Bingham, F.W.

    1992-01-01

    The regulations that currently govern repositories for spent fuel and high-level waste require demonstrations that are sometimes described as impossible to make. To make them will require an understanding of the current and the future phenomena at repository sites; it will also require credible estimates of the probabilities that the phenomena will occur in the distant future. Experts in many fields emdash earth sciences, statistics, numerical modeling, and the law emdash have questioned whether any amount of data collection can allow modelers to meet these requirements with enough confidence to satisfy the regulators. In recent years some performance assessments have begun to shed light on this question because they use results of actual site investigations. Although these studies do not settle the question definitively, a review of a recent total-system assessment suggests that compliance may be possible to demonstrate. The review also suggests, however, that the demonstration can be only at the ''reasonable'' levels of assurance mentioned, but not defined, in the regulations

  11. 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

  12. 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.

  13. 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

  14. 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.)

  15. Early Site Permit Demonstration Program: Regulatory criteria evaluation report

    International Nuclear Information System (INIS)

    1993-03-01

    The primary objective of the Early Site Plan Demonstration Program (ESPDP) is to demonstrate successfully the use of 10CFR52 to obtain ESPs for one or more US sites for one (or more) ALWR nuclear power plants. It is anticipated that preparation of the ESP application and interaction with NRC during the application review process will result not only in an ESP for the applicant(s) but also in the development of criteria and definition of processes, setting the precedent that facilitates ESPs for subsequent ESP applications. Because siting regulatory processes and acceptance criteria are contained in over 100 separate documents, comprehensive licensing and technical reviews were performed to establish whether the requirements and documentation are self-consistent, whether the acceptance criteria are sufficiently well-defined and clear, and whether the licensing process leading to the issuance of an ESP is unambiguously specified. This document provides appendices C and D of this report. Appendix C contains data from the licensing and technical reviews; Appendix D contains technology toolkit data sheets

  16. 40 CFR 63.2166 - How do I demonstrate initial compliance with the emission limitations if I monitor brew ethanol?

    Science.gov (United States)

    2010-07-01

    ... with the emission limitations if I monitor brew ethanol? 63.2166 Section 63.2166 Protection of... demonstrate initial compliance with the emission limitations if I monitor brew ethanol? (a) You must... subpart. (b) You must establish the brew-to-exhaust correlation for each fermentation stage according to...

  17. 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

  18. 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.

  19. 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.

  20. 40 CFR 63.7334 - How do I demonstrate continuous compliance with the work practice standards that apply to me?

    Science.gov (United States)

    2010-07-01

    ... for each oven and records indicating the legitimate operational reason for any change in the pushing... least 3 hours of observations (thirty 6-minute averages) to demonstrate initial compliance does not apply. (5) If fewer than six but at least four 15-second observations can be made, use the average of...

  1. 40 CFR 1033.240 - Demonstrating compliance with exhaust emission standards.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) AIR POLLUTION CONTROLS CONTROL OF EMISSIONS FROM LOCOMOTIVES Certifying Engine Families § 1033... engine family is considered in compliance with the applicable numerical emission standards in § 1033.101... certify by design without new emission test data. To do this, submit the application for certification...

  2. 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 ...

  3. "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.

  4. 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.

  5. 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

  6. Performance Demonstration Program Plan for RCRA Constituent Analysis of Solidified Wastes

    International Nuclear Information System (INIS)

    2006-01-01

    The Performance Demonstration Program (PDP) for Resource Conservation and Recovery Act (RCRA) constituents distributes test samples for analysis of volatile organic compounds (VOCs), semivolatile organic compounds (SVOCs), and metals in solid matrices. Each distribution of test samples is termed a PDP cycle. These evaluation cycles provide an objective measure of the reliability of measurements performed for transuranic (TRU) waste characterization. The primary documents governing the conduct of the PDP are the Quality Assurance Program Document (QAPD; DOE/CBFO-94-1012) and the Waste Isolation Pilot Plant (WIPP) Waste Analysis Plan (WAP) contained in the Hazardous Waste Facility Permit (NM4890139088-TSDF) issued by the New Mexico Environment Department. The WAP requires participation in the PDP; the PDP must comply with the QAPD and the WAP. This plan implements the general requirements of the QAPD and the applicable requirements of the WAP for the RCRA PDP. Participating laboratories demonstrate acceptable performance by successfully analyzing single-blind performance evaluation samples (subsequently referred to as PDP samples) according to the criteria established in this plan. PDP samples are used as an independent means to assess laboratory performance regarding compliance with the WAP quality assurance objectives (QAOs). The concentrations of analytes in the PDP samples address levels of regulatory concern and encompass the range of concentrations anticipated in waste characterization samples. The WIPP requires analyses of homogeneous solid wastes to demonstrate compliance with regulatory requirements. These analyses must be performed by laboratories that demonstrate acceptable performance in this PDP. These analyses are referred to as WIPP analyses, and the samples on which they are performed are referred to as WIPP samples. Participating laboratories must analyze PDP samples using the same procedures used for WIPP samples.

  7. Sociotechnical systems as a framework for regulatory system design and evaluation: Using Work Domain Analysis to examine a new regulatory system.

    Science.gov (United States)

    Carden, Tony; Goode, Natassia; Read, Gemma J M; Salmon, Paul M

    2017-03-15

    Like most work systems, the domain of adventure activities has seen a series of serious incidents and subsequent calls to improve regulation. Safety regulation systems aim to promote safety and reduce accidents. However, there is scant evidence they have led to improved safety outcomes. In fact there is some evidence that the poor integration of regulatory system components has led to adverse safety outcomes in some contexts. Despite this, there is an absence of methods for evaluating regulatory and compliance systems. This article argues that sociotechnical systems theory and methods provide a suitable framework for evaluating regulatory systems. This is demonstrated through an analysis of a recently introduced set of adventure activity regulations. Work Domain Analysis (WDA) was used to describe the regulatory system in terms of its functional purposes, values and priority measures, purpose-related functions, object-related processes and cognitive objects. This allowed judgement to be made on the nature of the new regulatory system and on the constraints that may impact its efficacy following implementation. Importantly, the analysis suggests that the new system's functional purpose of ensuring safe activities is not fully supported in terms of the functions and objects available to fulfil them. Potential improvements to the design of the system are discussed along with the implications for regulatory system design and evaluation across the safety critical domains generally. Copyright © 2017 Elsevier Ltd. All rights reserved.

  8. 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

  9. 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

  10. 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.

  11. 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

  12. Disposal demonstration of a high integrity container (HIC) containing an EPICOR-II prefilter from Three Mile Island

    International Nuclear Information System (INIS)

    McConnell, J.W. Jr.; Tyacke, M.J.; Schmitt, R.C.; Reno, H.W.

    1985-02-01

    A high integrity container (HIC) was developed, tested, and certified for use in disposing of unusual low-level radioactive waste from Three Mile Island Unit 2 (TMI-2). The work was coordinated by EG and G Idaho, Inc. and funded by the US Department of Energy. A disposal demonstration using an HIC containing an EPICOR-II prefilter from TMI-2 was completed at the commercial disposal facility in the State of Washington. A Certification of Compliance was issued by the Department of Social and Health Services of the State of Washington to use the HIC in disposing of up to 50 EPICOR-II prefilters. That Certification of Compliance was issued after rigorous review of the HIC design and test program by the State and by the US Nuclear Regulatory Commission. This report describes the processes of loading, transporting, and disposing of the demonstration HIC and briefly describes the design, testing, and approval effort leading up to the demonstration

  13. 77 FR 40817 - Low-Level Radioactive Waste Regulatory Management Issues

    Science.gov (United States)

    2012-07-11

    ...-2011-0012] RIN-3150-AI92 Low-Level Radioactive Waste Regulatory Management Issues AGENCY: Nuclear... regulatory time of compliance for a low-level radioactive waste disposal facility, allowing licensees the... system, and revising the NRC's licensing requirements for land disposal of radioactive waste. DATES: The...

  14. Accounting for water in the minerals industry: Capitalising on regulatory reporting

    Directory of Open Access Journals (Sweden)

    Rikki A. Garstone

    2017-12-01

    Full Text Available Australia has been rapidly advancing the field of water accounting as a tool to improve water management across the country. Water accounting is the application of a consistent and structured approach to identify, measure and report water resource information. The Bureau of Meteorology (the Bureau has developed Australian Water Accounting Standards for General Purpose Water Accounting Reports.Following collaboration between the Bureau and the Newmarket Gold Mining Company, this paper investigates how General Purpose Water Account Reporting can be applied and used in the minerals industry to simplify and improve aspects of regulatory reporting. This case study demonstrates how General Purpose Water Accounting Reports and the lessons learned from the ongoing development of the Australian National Water Account can be practically applied to regulatory reporting and corporate data management for a mining operation in the Australian Northern Territory. This paper also demonstrates the benefits of aligning a standardised water account with data that is already routinely collected as part of mining operations environmental compliance.

  15. 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...

  16. 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.

  17. Standard compliance - NDE performance demonstration/inspection in the CANDU industry

    International Nuclear Information System (INIS)

    Choi, E.

    2011-01-01

    CANDU nuclear power plants are operated in 3 provinces in Canada for electric power generation. A table in the paper will show the built and operating plants in Ontario, Quebec, New Brunswick and overseas. The regulator for nuclear power in Canada is the Canadian Nuclear Safety Commission (CNSC). The CNSC holds the plant licensees accountable for compliance to CSA N285.4 for periodic inspections. The Standard basically specifies the 'what, when, where, how, how much and how frequently' NDE is to be done on pressure retaining systems and components in CANDU nuclear power plants. In inspection methods, the Standard specifies they must be non-destructive. The NDE methods were grouped into visual, dimensional, surface, volumetric and integrative. The Standard also specifies that the licensees are responsible for the performance demonstration (PD) of the adequacy of the procedures and the proficiency of the personnel. This paper describes the Standard's requirement in NDE qualification and presents a joint project participated by Canadian and overseas CANDU owners. The sub-project for NDE included providing evidence and technical justification on the adequacy of the procedures and the proficiency of the personnel. The paper describes the qualification methodology followed by the participants. This will be followed by how the participants produced Inspection Specification, tools and procedures, personnel training and qualification programs, test and qualification samples, independent peer reviews and Technical Justification. (author)

  18. 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

  19. 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

  20. 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

  1. 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

  2. Impact of regulatory science on global public health

    Directory of Open Access Journals (Sweden)

    Meghal Patel

    2012-07-01

    Full Text Available Regulatory science plays a vital role in protecting and promoting global public health by providing the scientific basis for ensuring that food and medical products are safe, properly labeled, and effective. Regulatory science research was first developed for the determination of product safety in the early part of the 20th Century, and continues to support innovation of the processes needed for regulatory policy decisions. Historically, public health laws and regulations were enacted following public health tragedies, and often the research tools and techniques required to execute these laws lagged behind the public health needs. Throughout history, similar public health problems relating to food and pharmaceutical products have occurred in countries around the world, and have usually led to the development of equivalent solutions. For example, most countries require a demonstration of pharmaceutical safety and efficacy prior to marketing these products using approaches that are similar to those initiated in the United States. The globalization of food and medical products has created a shift in regulatory compliance such that gaps in food and medical product safety can generate international problems. Improvements in regulatory research can advance the regulatory paradigm toward a more preventative, proactive framework. These improvements will advance at a greater pace with international collaboration by providing additional resources and new perspectives for approaching and anticipating public health problems. The following is a review of how past public health disasters have shaped the current regulatory landscape, and where innovation can facilitate the shift from reactive policies to proactive policies.

  3. Impact of regulatory science on global public health.

    Science.gov (United States)

    Patel, Meghal; Miller, Margaret Ann

    2012-07-01

    Regulatory science plays a vital role in protecting and promoting global public health by providing the scientific basis for ensuring that food and medical products are safe, properly labeled, and effective. Regulatory science research was first developed for the determination of product safety in the early part of the 20th Century, and continues to support innovation of the processes needed for regulatory policy decisions. Historically, public health laws and regulations were enacted following public health tragedies, and often the research tools and techniques required to execute these laws lagged behind the public health needs. Throughout history, similar public health problems relating to food and pharmaceutical products have occurred in countries around the world, and have usually led to the development of equivalent solutions. For example, most countries require a demonstration of pharmaceutical safety and efficacy prior to marketing these products using approaches that are similar to those initiated in the United States. The globalization of food and medical products has created a shift in regulatory compliance such that gaps in food and medical product safety can generate international problems. Improvements in regulatory research can advance the regulatory paradigm toward a more preventative, proactive framework. These improvements will advance at a greater pace with international collaboration by providing additional resources and new perspectives for approaching and anticipating public health problems. The following is a review of how past public health disasters have shaped the current regulatory landscape, and where innovation can facilitate the shift from reactive policies to proactive policies. Copyright © 2012. Published by Elsevier B.V.

  4. 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

  5. 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

  6. WIPP shaft seal system parameters recommended to support compliance calculations

    International Nuclear Information System (INIS)

    Hurtado, L.D.; Knowles, M.K.; Kelley, V.A.; Jones, T.L.; Ogintz, J.B.; Pfeifle, T.W.

    1997-12-01

    The US Department of Energy plans to dispose of transuranic waste at the Waste Isolation Pilot Plant (WIPP), which is sited in southeastern New Mexico. The WIPP disposal facility is located approximately 2,150 feet (650 m) below surface in the bedded halite of the Salado Formation. Prior to initiation of disposal activities, the Department of Energy must demonstrate that the WIPP will comply with all regulatory requirements. Applicable regulations require that contaminant releases from the WIPP remain below specified levels for a period of 10,000 years. To demonstrate that the WIPP will comply with these regulations, the Department of Energy has requested that Sandia National Laboratories develop and implement a comprehensive performance assessment of the WIPP repository for the regulatory period. This document presents the conceptual model of the shaft sealing system to be implemented in performance assessment calculations conducted in support of the Compliance Certification Application for the WIPP. The model was developed for use in repository-scale calculations and includes the seal system geometry and materials to be used in grid development as well as all parameters needed to describe the seal materials. These calculations predict the hydrologic behavior of the system. Hence conceptual model development is limited to those processes that could impact the fluid flow through the seal system

  7. WIPP shaft seal system parameters recommended to support compliance calculations

    Energy Technology Data Exchange (ETDEWEB)

    Hurtado, L.D.; Knowles, M.K. [Sandia National Labs., Albuquerque, NM (United States); Kelley, V.A.; Jones, T.L.; Ogintz, J.B. [INTERA Inc., Austin, TX (United States); Pfeifle, T.W. [RE/SPEC, Inc., Rapid City, SD (United States)

    1997-12-01

    The US Department of Energy plans to dispose of transuranic waste at the Waste Isolation Pilot Plant (WIPP), which is sited in southeastern New Mexico. The WIPP disposal facility is located approximately 2,150 feet (650 m) below surface in the bedded halite of the Salado Formation. Prior to initiation of disposal activities, the Department of Energy must demonstrate that the WIPP will comply with all regulatory requirements. Applicable regulations require that contaminant releases from the WIPP remain below specified levels for a period of 10,000 years. To demonstrate that the WIPP will comply with these regulations, the Department of Energy has requested that Sandia National Laboratories develop and implement a comprehensive performance assessment of the WIPP repository for the regulatory period. This document presents the conceptual model of the shaft sealing system to be implemented in performance assessment calculations conducted in support of the Compliance Certification Application for the WIPP. The model was developed for use in repository-scale calculations and includes the seal system geometry and materials to be used in grid development as well as all parameters needed to describe the seal materials. These calculations predict the hydrologic behavior of the system. Hence conceptual model development is limited to those processes that could impact the fluid flow through the seal system.

  8. 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.

  9. 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)

  10. 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...

  11. 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.

  12. 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.).

  13. 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.)

  14. Demonstration of a repository performance assessment capability at the US Nuclear Regulatory Commission

    International Nuclear Information System (INIS)

    Codell, R.; Eisenberg, N.; McCartin, T.; Park, J.

    1991-01-01

    In order to better review licensing submittals for a High-Level Waste Repository, the US Nuclear Regulatory Commission staff has expanded and improved its capability to conduct performance assessments. A demonstration of this capability used the limited data from Yucca Mountain, Nevada to investigate a small set of scenario classes. Models of release and transport of radionuclides from a repository via the groundwater and direct release pathways provided preliminary estimates of releases to the accessible environment for a 10,000 year simulation time. Latin hypercube sampling of input parameters was used to express results as distributions and to investigate model sensitivities. This methodology demonstration should not be interpreted as an estimate of performance of the proposed repository at Yucca Mountain, Nevada

  15. 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

  16. 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...

  17. 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...

  18. 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…

  19. 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

  20. 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.

  1. 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

  2. 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...

  3. 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...

  4. 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)

  5. [Insufficient medication compliance in Parkinson's disease].

    Science.gov (United States)

    Aerts, Marjolein B; van der Eijk, Martijn; Kramers, Kees; Bloem, Bastiaan R

    2011-01-01

    Medication compliance is generally suboptimal, particularly in patients with complex polypharmacy. This generic treatment problem is described here for Parkinson's disease (PD). We would expect patients with PD to have good medication compliance, since missed doses immediately result in worsening of symptoms. However, recent research has revealed that PD patients demonstrate poor medication compliance. Poor medication compliance is particularly undesirable for patients with PD because regular intake of medication is required for optimal treatment effect. Possible ways of improving medication compliance are pharmacotherapeutic measures and behavioural interventions. Modern methods of communication (text message reminders) and 'smart' pill dispensers may be beneficial, but the advantages of such interventions have not yet been scientifically studied.

  6. 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

  7. 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...

  8. 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

  9. 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

  10. 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)

  11. Early Site Permit Demonstration Program: Regulatory criteria evaluation report

    Energy Technology Data Exchange (ETDEWEB)

    1993-03-01

    The primary objective of the ESPDP is to demonstrate successfully the use of 10CFR52 to obtain ESPs for one or more US sites for one (or more) ALWR nuclear power plants. It is anticipated that preparation of the ESP application and interaction with NRC during the application review process will result not only in an ESP for the applicant(s) but also in the development of criteria and definition of processes, setting the precedent that facilitates ESPs for subsequent ESP applications. Because siting regulatory processes and acceptance criteria are contained in over 100 separate documents, comprehensive licensing and technical reviews were performed to establish whether the requirements and documentation are self-consistent, whether the acceptance criteria are sufficiently well-defined and clear, and whether the licensing process leading to the issuance of an ESP is unambiguously specified. The results of the technical and licensing evaluations are presented in this report. The purpose, background, and organization of the ESPDP is delineated in Section 1. Section 11 contains flowcharts defining siting application requirements, environmental report requirements, and emergency planning/preparedness requirements for ALWRS. The licensing and technical review results are presented in Section III.

  12. Early Site Permit Demonstration Program: Regulatory criteria evaluation report

    International Nuclear Information System (INIS)

    1993-03-01

    The primary objective of the ESPDP is to demonstrate successfully the use of 10CFR52 to obtain ESPs for one or more US sites for one (or more) ALWR nuclear power plants. It is anticipated that preparation of the ESP application and interaction with NRC during the application review process will result not only in an ESP for the applicant(s) but also in the development of criteria and definition of processes, setting the precedent that facilitates ESPs for subsequent ESP applications. Because siting regulatory processes and acceptance criteria are contained in over 100 separate documents, comprehensive licensing and technical reviews were performed to establish whether the requirements and documentation are self-consistent, whether the acceptance criteria are sufficiently well-defined and clear, and whether the licensing process leading to the issuance of an ESP is unambiguously specified. The results of the technical and licensing evaluations are presented in this report. The purpose, background, and organization of the ESPDP is delineated in Section 1. Section 11 contains flowcharts defining siting application requirements, environmental report requirements, and emergency planning/preparedness requirements for ALWRS. The licensing and technical review results are presented in Section III

  13. 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.

  14. 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...

  15. 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')

  16. 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...

  17. 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

  18. 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.

  19. 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...

  20. 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...

  1. Basis to demonstrate compliance with the National Emission Standards for Hazardous Air Pollutants for the Stand-off Experiments Range

    Energy Technology Data Exchange (ETDEWEB)

    Michael Sandvig

    2011-01-01

    The purpose of this report is to provide the basis and the documentation to demonstrate general compliance with the National Emission Standard for Hazardous Air Pollutants (NESHAPS) 40 CFR 61 Subpart H, “National Emission Standards for Emissions of Radionuclides Other Than Radon from Department of Energy Facilities,” (the Standard) for outdoor linear accelerator operations at the Idaho National Laboratory (INL) Stand-off Experiments Range (SOX). The intent of this report is to inform and gain acceptance of this methodology from the governmental bodies regulating the INL.

  2. 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

  3. 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…

  4. 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

  5. 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)

  6. 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...

  7. 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

  8. 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...

  9. 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...

  10. 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

  11. 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

  12. 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

  13. 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...

  14. The dual effects of leading for safety: The mediating role of employee regulatory focus.

    Science.gov (United States)

    Kark, Ronit; Katz-Navon, Tal; Delegach, Marianna

    2015-09-01

    This study examined the underlying mechanisms through which transformational and transactional leadership influence employee safety behaviors. Linking leadership theory with self-regulatory focus (SRF) theory, we examined a model of dual effects of leadership on safety initiative and safety compliance behaviors as mediated by promotion and prevention self-regulations. We conducted an experimental study (N = 107), an online study (N = 99) and a field study (N = 798 employees and 49 managers). Results demonstrated that followers' situational promotion focus mediated the positive relationship between transformational leadership and safety initiative behaviors. Through all 3 studies, transactional active leadership was positively associated with followers' situational prevention focus, however, the association between followers' prevention focus and safety compliance behaviors was inconsistent, showing the expected mediation relationships in the experimental setting, but not in the online and field studies. We discuss theoretical and practical implications of the findings. (c) 2015 APA, all rights reserved).

  15. 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

  16. 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.

  17. Considerations about the impact of the Convention on Nuclear Safety on the regulatory action of the CNEN in Brazilian nuclear power plants

    International Nuclear Information System (INIS)

    Camargo, Claudio; Pontedeiro, Auro

    1995-01-01

    Preliminary discussion is conducted about the impact of the terms of the Convention on Nuclear safety, adopted by Diplomatic Conference in September 1994 in the International Atomic Energy Agency, on the regulatory action of Brazilian Nuclear Regulatory Body - CNEN. Following the Convention articles structure, the paper emphasizes technical aspects of the nuclear safety standards adopted in the licensing process of Brazilian Nuclear Power Plants. The recent experience in the issuance of Angra-1 NPP Permanent Operation Authorization is used to demonstrate that current safety standards in Brazil are in compliance with the international compromises and in agreement with what is expected by the so called Safety Culture. (author). 9 refs

  18. 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)

  19. 40 CFR 63.1451 - How do I demonstrate initial compliance with the emission limitations, work practice standards...

    Science.gov (United States)

    2010-07-01

    ... compliance status according to the requirements in § 63.1454(e). (f) Venturi wet scrubbers. For each venturi... compliance status that you will operate the venturi wet scrubber within the established operating limits for... baghouse or venturi wet scrubber subject to operating limits in § 63.1444(h) or § 63.1446(e), you have...

  20. 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...

  1. 34 CFR 366.63 - What evidence must a center present to demonstrate that it is in minimum compliance with the...

    Science.gov (United States)

    2010-07-01

    ... compliance with the evaluation standards? (a) Compliance indicator 1—Philosophy—(1) Consumer control. (i) The... it is in minimum compliance with the evaluation standards? 366.63 Section 366.63 Education... REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION CENTERS FOR INDEPENDENT LIVING Evaluation Standards and...

  2. 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...

  3. 40 CFR 63.4330 - By what date must I conduct the initial compliance demonstration?

    Science.gov (United States)

    2010-07-01

    ... operations, the organic HAP emission rate for the initial compliance period was equal to or less than the applicable emission limit in Table 1 to this subpart and for dyeing/finishing operations, the mass fraction...

  4. Guidance and methods for satisfying low specific activity material and surface contaminated object regulatory requirements

    International Nuclear Information System (INIS)

    Pope, R.B.; Shappert, L.B.; Michelhaugh, R.D.; Boyle, R.W.; Easton, E.P.; Coodk, J.R.

    1998-01-01

    The U.S. Department of Transportation (DOT) and the U.S. Nuclear Regulatory Commission (NRC) have prepared a comprehensive set of draft guidance for shippers and inspectors to use when applying the newly imposed regulatory requirements for low specific activity (LSA) material and surface contaminated objects (SCOs). These requirements represent significant departures in some areas from the manner in which these materials and objects were regulated by the earlier versions of the regulations. The proper interpretation and application of the regulatory criteria can require a fairly complex set of decisions be made. To assist those trying these regulatory requirements, a detailed set of logic-flow diagrams representing decisions related to multiple factors were prepared and included in the draft report for comment on Categorizing and Transporting Low Specific Activity Materials and Surface Contaminated Objects, (DOT/NRC, 1997). These logic-flow diagrams, as developed, are specific to the U.S. regulations, but were readily adaptable to the IAEA regulations. The diagrams have been modified accordingly and tied directly to specific paragraphs in IAEA Safety Series No. 6. This paper provides the logic-flow diagrams adapted in the IAEA regulations, and demonstrated how these diagrams can be used to assist consignors and inspectors in assessing compliance of shipments with the LSA material and SCO regulatory requirements. (authors)

  5. 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

  6. 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.

  7. 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

  8. Demonstration of close-coupled barriers for subsurface containment of buried waste

    International Nuclear Information System (INIS)

    Heiser, J.; Dwyer, B.

    1995-01-01

    The primary objective of this project is to develop and demonstrate a close-coupled barrier for the containment of subsurface waste or contaminant migration. A close-coupled barrier is produced by first installing a conventional cement grout curtain followed by a thin lining of a polymer grout. The resultant barrier is a cement polymer composite that has economic benefits derived from the cement and performance benefits from the durable and resistant polymer layer. Close-coupled barrier technology is applicable for final, interim, or emergency containment of subsurface waste forms. Consequently, when considering the diversity of technology application, the construction emplacement and material technology maturity, general site operational requirements, and regulatory compliance incentives, the close-coupled barrier system provides an alternative for any hazardous or mixed waste remediation plan. This paper will discuss the installation of a close-coupled barrier and the subsequent integrity verification. The demonstration will take place at a cold site at the Hanford Geotechnical Test Facility, 400 Area, Hanford, Washington

  9. 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

  10. 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...

  11. 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

  12. 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

  13. 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

  14. 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.

  15. 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)

  16. 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.

  17. 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

  18. 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

  19. Regulator's Workshop on The Role of Future Society and Biosphere in Demonstrating Compliance with High-Level Radioactive Waste Disposal Standards and Regulations

    International Nuclear Information System (INIS)

    Avila, R.; Blommaert, W.; Clark, R.

    2002-09-01

    This report summarizes the proceedings of a workshop, co-sponsored by the U.S. Environmental Protection Agency (US EPA) and the Swedish Radiation Protection Authority (SSI). The invitations to participate in the Workshop were primarily extended to authorities in countries with major nuclear waste programs involving geological disposal and using performance assessment methodology. The main objective of the Workshop was to develop a common understanding among regulators of the role of society and the biosphere in demonstrating compliance with regulations

  20. Compliance with Corporate Governance Principles: Australian Evidence

    Directory of Open Access Journals (Sweden)

    Maryam Safari

    2015-12-01

    Full Text Available This study investigates the association between the level of compliance of Australian listed companies with Australian corporate governance principles, in aggregate, and the level of discretionary accruals using the modified Jones model. It is hypothesised that higher levels of compliance would be associated with lower levels of discretionary accruals. Data from a random sample of 214 Australian listed companies for the years 2009 and 2010 were used to test the hypothesis. The results demonstrate a significant negative relationship indicating that companies with higher levels of compliance engage in lower levels of earnings management via discretionary accruals.

  1. 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

  2. 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.

  3. Electronic compliance monitoring of topical treatment after ophthalmic surgery.

    Science.gov (United States)

    Hermann, Manuel Marcel; Ustündag, Can; Diestelhorst, Michael

    2010-08-01

    The success of many medical treatments is built on compliance. Electronic monitoring is the most accurate tool to quantify compliance by measuring adherence. In order to assess the efficiency of a recently introduced miniature monitoring device for eye drop application, we evaluated adherence in ophthalmic patients undergoing post-operative short-term topical treatment. This pilot study enrolled 30 outpatients (mean age 61.8 +/- 18.5 years) after cataract (n = 24) and glaucoma filtration surgery (n = 6) applying fixed-combination eye drops containing prednisolone and gentamicin five times daily for 2 weeks. Patients received eye drops in conventional bottles each equipped with a miniature monitoring device recording events of application. Two patients failed to bring back the monitoring device; therefore data collected from only 28 patients could be examined. Data showed highly variable results with a mean dose compliance of 50.2%. Dose compliance was below 25% in approximately one out of five patients. Four cataract patients, but no glaucoma patient, discontinued therapy prematurely. The observed mean dosage interval was calculated for each patient and ranged 4.6-19.7 h. Thirty percent of analysed dosage intervals exceeded 12.0 h. Different patterns of compliance behaviour-like early non-persistence, drug holiday and low treatment frequency could be identified and illustrated using electronic data. Age or gender did not significantly influence compliance rates. Our pilot study demonstrates successful electronic compliance monitoring using a technology capable of continuous data recording over weeks of treatment. The low compliance rate for a relevant part of the patients demonstrates the necessity to study and improve compliance in ophthalmology. In future, new application methods and electronic application devices may improve treatment response in eye care.

  4. 40 CFR 63.4551 - How do I demonstrate initial compliance with the emission limitations?

    Science.gov (United States)

    2010-07-01

    ... of Plastic Parts and Products Compliance Requirements for the Emission Rate Without Add-on Controls... cleaning materials that have been reclaimed on-site, the amount of each used in a month may be reduced by... other additive, and cleaning material used during each month by measurement or usage records. If you...

  5. 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.

  6. Safety standards for near surface disposal and the safety case and supporting safety assessment for demonstrating compliance with the standards

    International Nuclear Information System (INIS)

    Metcalf, P.

    2003-01-01

    The report presents the safety standards for near surface disposal (ICRP guidance and IAEA standards) and the safety case and supporting safety assessment for demonstrating compliance with the standards. Special attention is paid to the recommendations for disposal of long-lived solid radioactive waste. The requirements are based on the principle for the same level of protection of future individuals as for the current generation. Two types of exposure are considered: human intrusion and natural processes and protection measures are discussed. Safety requirements for near surface disposal are discussed including requirements for protection of human health and environment, requirements or safety assessments, waste acceptance and requirements etc

  7. 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.

  8. 40 CFR Table 6 to Subpart Uuuu of... - Continuous Compliance With Operating Limits

    Science.gov (United States)

    2010-07-01

    ... compliance demonstration. 3. water scrubber maintain the daily average scrubber pressure drop and scrubber... alkalinity within the range of values established during the compliance demonstration collecting the scrubber pressure drop, scrubber liquid flow rate, and scrubber liquid pH, conductivity, or alkalinity data...

  9. 40 CFR 63.11467 - What are the initial compliance demonstration requirements for new and existing sources?

    Science.gov (United States)

    2010-07-01

    ... Pollutants for Secondary Nonferrous Metals Processing Area Sources Standards, Compliance, and Monitoring... for structural integrity and fabric filter condition. You must record the results of the inspection...

  10. 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

  11. The safety, efficacy and regulatory triangle in drug development: Impact for animal models and the use of animals.

    Science.gov (United States)

    van Meer, Peter J K; Graham, Melanie L; Schuurman, Henk-Jan

    2015-07-15

    Nonclinical studies in animals are conducted to demonstrate proof-of-concept, mechanism of action and safety of new drugs. For a large part, in particular safety assessment, studies are done in compliance with international regulatory guidance. However, animal models supporting the initiation of clinical trials have their limitations, related to uncertainty regarding the predictive value for a clinical condition. The 3Rs principles (refinement, reduction and replacement) are better applied nowadays, with a more comprehensive application with respect to the original definition. This regards also regulatory guidance, so that opportunities exist to revise or reduce regulatory guidance with the perspective that the optimal balance between scientifically relevant data and animal wellbeing or a reduction in animal use can be achieved. In this manuscript we review the connections in the triangle between nonclinical efficacy/safety studies and regulatory aspects, with focus on in vivo testing of drugs. These connections differ for different drugs (chemistry-based low molecular weight compounds, recombinant proteins, cell therapy or gene therapy products). Regarding animal models and their translational value we focus on regulatory aspects and indications where scientific outcomes warrant changes, reduction or replacement, like for, e.g., biosimilar evaluation and safety testing of monoclonal antibodies. On the other hand, we present applications where translational value has been clearly demonstrated, e.g., immunosuppressives in transplantation. Especially for drugs of more recent date like recombinant proteins, cell therapy products and gene therapy products, a regulatory approach that allows the possibility to conduct combined efficacy/safety testing in validated animal models should strengthen scientific outcomes and improve translational value, while reducing the numbers of animals necessary. Copyright © 2015 Elsevier B.V. All rights reserved.

  12. 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

  13. 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...

  14. 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.

  15. 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

  16. 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)

  17. 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

  18. 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.

  19. 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

  20. 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)

  1. Use of PRA in the nuclear regulatory field in South Africa

    International Nuclear Information System (INIS)

    Hill, T.F.

    1994-01-01

    The nuclear regulatory authority in South Africa (since 1988 the Council for Nuclear Safety (CNS)), established in 1973 nuclear safety criteria against which to assess the level of safety of any facility using radioactive material. It is a regulatory requirement in South Africa to develop and maintain a living PRA for each facility and thereby to provide the necessary information to demonstrate compliance against these criteria. All safety submissions to the CNS must include at least a risk statement based on an accepted PRA study. The function of the CNS is to regulate all activities in South Africa involving the use of radioactive material and posing a significant risk to the public or plant personnel. This includes most aspects of the nuclear fuel cycle and the Koeberg NPS (two 2775 MW(th) PWRs). A PRA study including source terms for the two Koeberg units was presented by the contractor in 1979. This included the risk due to power and shutdown states and non reactor related accidents involving spent fuel storage, fuel handling and waste treatment related activities. At least 20 PRA studies have been performed for other nuclear facilities in the country. The CNS maintains an in-house PRA capability to perform independent assessments of licensee submission, to participate in developments of PRA methodology in the regulatory field, to perform pro-active safety work and to assist in regulatory decision making. Present ongoing work includes the development of a risk monitor, a risk management system, improvement in PRA codes, models, data collection and analysis, off-site risk assessment methodology and associated regulatory policy. (author). 1 fig

  2. TOPSEAL '96. Demonstrating the practical achievements of nuclear waste management and disposal - Transactions Vol.II: Poster Papers

    International Nuclear Information System (INIS)

    1996-01-01

    Posters have been presented in the 5 plenary sessions on: Existing facilities and operating experiences; Optimization strategies in radwaste management; Planning for future repositories; Underground laboratories; Legal and regulatory requirements - implementation and compliance

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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. 

  9. 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.

  10. 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.

  11. 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.

  12. 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).

  13. 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)

  14. 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

  15. 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

  16. 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

  17. 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)

  18. 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.

  19. 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

  20. 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)

  1. 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)

  2. Demonstration of close-coupled barriers for subsurface containment of buried waste

    International Nuclear Information System (INIS)

    Dwyer, B.P.; Heiser, J.; Stewart, W.

    1996-01-01

    The primary objective of this project is to develop and demonstrate a close-coupled barrier for the containment of subsurface waste or contaminant migration. A close-coupled barrier is produced by first installing a conventional cement grout curtain followed by a thin inner lining of a polymer grout. The resultant barrier is a cement polymer composite that has economic benefits derived from the cement and performance benefits from the durable and resistant polymer layer. Close-coupled barrier technology is applicable for final, interim, or emergency containment of subsurface waste forms. Consequently, when considering the diversity of technology application, the construction emplacement and material technology maturity, general site operational requirements, and regulatory compliance incentives, the close-coupled barrier system provides an alternative for any hazardous or mixed waste remediation plan. This paper discusses the installation of a close-coupled barrier and the subsequent integrity verification

  3. 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

  4. Performance Assessment Position Paper: Time for Compliance

    International Nuclear Information System (INIS)

    Wilhite, E.L.

    2003-01-01

    This study lays out the historical development of the time frame for a low-level waste disposal facility to demonstrate compliance with the DOE performance objectives and requirements. The study recommends that 1,000 years should be used as the time for compliance for all of the performance objectives and requirements (i.e., for the all-pathways, air pathway, radon emanation, water resource protection and inadvertent intruder analyses) for all low-level waste disposal facility performance assessments at the Savannah River Site

  5. Regulator's Workshop on The Role of Future Society and Biosphere in Demonstrating Compliance with High-Level Radioactive Waste Disposal Standards and Regulations

    Energy Technology Data Exchange (ETDEWEB)

    Avila, R. [Swedish Radiation Protection Authority, Stockholm (Sweden); Blommaert, W. [Agence Federale de Controle Nucleaire, Bruxelles (Belgium); Clark, R. [US Environmental Protection Agency (United States)] [and others

    2002-09-01

    This report summarizes the proceedings of a workshop, co-sponsored by the U.S. Environmental Protection Agency (US EPA) and the Swedish Radiation Protection Authority (SSI). The invitations to participate in the Workshop were primarily extended to authorities in countries with major nuclear waste programs involving geological disposal and using performance assessment methodology. The main objective of the Workshop was to develop a common understanding among regulators of the role of society and the biosphere in demonstrating compliance with regulations.

  6. Scenario development for the Waste Isolation Pilot Plant compliance certification application

    International Nuclear Information System (INIS)

    GALSON, D.A.; SWIFT, PETER N.; ANDERSON, D. RICHARD; BENNETT, D.G.

    1998-01-01

    Demonstrating compliance with the applicable regulations for the Waste Isolation Pilot Plant (WIPP) requires an assessment of the long-term performance of the disposal system. Scenario development is one starting point of this assessment, and generates inquiry about the present state and future evolution of the disposal system. Scenario development consists of four tasks: (1) identifying and classifying features, events and processes (FEPs), (2) screening FEPs according to well-defined criteria, (3) forming scenarios (combinations of FEPs) in the context of regulatory performance criteria and (4) specifying of scenarios for consequence analysis. The development and screening of a comprehensive FEP list provides assurance that the identification of significant processes and events is complete, that potential interactions between FEPs are not overlooked, and that responses to possible questions are available and well documented. Two basic scenarios have been identified for the WIPP: undisturbed performance (UP) and disturbed performance (DP). The UP scenario is used to evaluate compliance with the Environmental Protection Agency's (EPA's) Individual Dose (40 CFR Section 191-15) and Groundwater Protection (40 CFR Section 191-24) standards and accounts for all natural-, waste- and repository-induced FEPs that survive the screening process. The DP scenario is required for assessment calculations for the EPA's cumulative release standard (Containment Requirements, 40 CFR Section 191-13) and accounts for disruptive future human events, which have an uncertain probability of occurrence, in addition to the UP FEPs

  7. 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.

  8. 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)

  9. 40 CFR 63.1413 - Compliance demonstration procedures.

    Science.gov (United States)

    2010-07-01

    ... to a customer, or make a product in excess of demand. (B) When § 63.7(g) references the Notification...). Said definition shall include an identification of each batch emission episode. The definition of batch... process knowledge or test data, to demonstrate that test periods are representative. Examples of...

  10. 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

  11. 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

  12. 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)

  13. 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.

  14. 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

  15. TU-AB-204-02: Device Adverse Events and Compliance

    Energy Technology Data Exchange (ETDEWEB)

    Gonzales, S. [Food & Drug Administration (United States)

    2016-06-15

    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

  16. Directory of certificates of compliance for radioactive materials packages. Volume 1. Summary report of NRC approved packages. Revision 6

    International Nuclear Information System (INIS)

    1983-09-01

    This directory contains a Summary Report of the US Nuclear Regulatory Commission's Approved Packages (Volume 1), all Certificates of Compliance (Volume 2), and Summary Report of NRC Approved Quality Assurance Programs (Volume 3) for Radioactive Material Packages effective September 14, 1983

  17. 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

  18. Levels and drivers of fishers' compliance with marine protected areas

    Directory of Open Access Journals (Sweden)

    Adrian Arias

    2015-12-01

    Full Text Available Effective conservation depends largely on people's compliance with regulations. We investigate compliance through the lens of fishers' compliance with marine protected areas (MPAs. MPAs are widely used tools for marine conservation and fisheries management. Studies show that compliance alone is a strong predictor of fish biomass within MPAs. Hence, fishers' compliance is critical for MPA effectiveness. However, there are few empirical studies showing what factors influence fishers' compliance with MPAs. Without such information, conservation planners and managers have limited opportunities to provide effective interventions. By studying 12 MPAs in a developing country (Costa Rica, we demonstrate the role that different variables have on fishers' compliance with MPAs. Particularly, we found that compliance levels perceived by resource users were higher in MPAs (1 with multiple livelihoods, (2 where government efforts against illegal fishing were effective, (3 where fishing was allowed but regulated, (4 where people were more involved in decisions, and (5 that were smaller. We also provide a novel and practical measure of compliance: a compound variable formed by the number illegal fishers and their illegal fishing effort. Our study underlines the centrality of people's behavior in nature conservation and the importance of grounding decision making on the social and institutional realities of each location.

  19. Proposed plan for regulatory supervision of PRR-1

    International Nuclear Information System (INIS)

    Garcia, Corazon M; Parami, Vangeline K.

    2000-05-01

    This study is intended to determine acceptable and reasonable criteria necessary to provide assurance of safety of the society in which the research reactor is to be operated in all stages of its lifetime. It is also deemed necessary to determine criteria for the establishment of a system of independent regulatory supervision to ensure compliance of PRR-1 with the established criteria for safety. The different criteria/standards concerning the radiological and nuclear safety of the PRR-1 during the stages of the design for repair/rehabilitation, commissioning, operation, and decommissioning were identified and enumerated. Recommendations were given on matters relating to regulatory supervision during stages of design and construction for repair/rehabilitation, commissioning, operation, and decommissioning of the PRR-1. (author)

  20. 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.

  1. Nuclear energy - some regulatory aspects

    International Nuclear Information System (INIS)

    Jennekens, Jon.

    1980-03-01

    The nuclear industry is often perceived by the public as being uniquely hazardous. As a consequence, the demands placed upon a nuclear regulatory agency invariably include sorting out the valid from the invalid. As the public becomes better informed, more time should become available for regulating the industry. The Canadian nuclear safety philosophy relies upon fundamental principle and basic criteria which licensees must show they are meeting at all stages in the development of a nuclear facility. In reactors, the concept of defence in depth involves the use of well-qualified personnel, compliance with national and international engineering codes and standards, the separation of process and safety systems, frequent testing of safety systems, redundancy in monitoring, control and initiation systems, multiple barriers against fission product release, and strict enforcement of compliance measurements. The Atomic Energy Control Board is writing a set of licensing guides to cover the whole nuclear fuel cycle; however, these will not lead to the impsition of a 'design by regulation' approach in Canada. (LL)

  2. Complying with the Federal Facilities Compliance Act

    International Nuclear Information System (INIS)

    Pavetto, C.S.; Watmore, A.S.

    1994-01-01

    The Federal Facilities Compliance Act (FFCA), signed into law on October 6, 1992, amended the Resource Conservation and Recovery Act (RCRA) to place significant additional environmental compliance responsibilities on federal facilities. The federal government has expressly waived sovereign immunity regarding hazardous waste enforcement action taken against these facilities by the states and the EPA. An exception exists for mixed waste violations. The FFCA defines mixed waste as hazardous waste, as defined by RCRA, combined with source, special nuclear or by-product material that is subject to the Atomic Energy Act of 1954. As the majority owner of mixed waste in the United States, the Department of Energy (DOE) must satisfy several new requirements under the FFCA for their facilities. This paper reviews the FFCA's requirements and how they apply to and may affect the DOE and other federal facilities. Included in the review are responsibilities of federal agencies involved and the role of the EPA and the states. In addition, this paper discusses the intent of the FFCA to encourage development of federal facility agreements (FFA) between federal agencies, the EPA and state environmental regulatory agencies

  3. 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

  4. Performance Demonstration Program Plan for Analysis of Simulated Headspace Gases

    International Nuclear Information System (INIS)

    2006-01-01

    The Performance Demonstration Program (PDP) for headspace gases distributes sample gases of volatile organic compounds (VOCs) for analysis. Participating measurement facilities (i.e., fixed laboratories, mobile analysis systems, and on-line analytical systems) are located across the United States. Each sample distribution is termed a PDP cycle. These evaluation cycles provide an objective measure of the reliability of measurements performed for transuranic (TRU) waste characterization. The primary documents governing the conduct of the PDP are the Quality Assurance Program Document (QAPD) (DOE/CBFO-94-1012) and the Waste Isolation Pilot Plant (WIPP) Waste Analysis Plan (WAP) contained in the Hazardous Waste Facility Permit (NM4890139088-TSDF) issued by the New Mexico Environment Department (NMED). The WAP requires participation in the PDP; the PDP must comply with the QAPD and the WAP. This plan implements the general requirements of the QAPD and the applicable requirements of the WAP for the Headspace Gas (HSG) PDP. Participating measurement facilities analyze blind audit samples of simulated TRU waste package headspace gases according to the criteria set by this PDP Plan. Blind audit samples (hereafter referred to as PDP samples) are used as an independent means to assess each measurement facility's compliance with the WAP quality assurance objectives (QAOs). To the extent possible, the concentrations of VOC analytes in the PDP samples encompass the range of concentrations anticipated in actual TRU waste package headspace gas samples. Analyses of headspace gases are required by the WIPP to demonstrate compliance with regulatory requirements. These analyses must be performed by measurement facilities that have demonstrated acceptable performance in this PDP. These analyses are referred to as WIPP analyses and the TRU waste package headspace gas samples on which they are performed are referred to as WIPP samples in this document. Participating measurement

  5. Performance Demonstration Program Plan for Analysis of Simulated Headspace Gases

    International Nuclear Information System (INIS)

    2007-01-01

    The Performance Demonstration Program (PDP) for headspace gases distributes blind audit samples in a gas matrix for analysis of volatile organic compounds (VOCs). Participating measurement facilities (i.e., fixed laboratories, mobile analysis systems, and on-line analytical systems) are located across the United States. Each sample distribution is termed a PDP cycle. These evaluation cycles provide an objective measure of the reliability of measurements performed for transuranic (TRU) waste characterization. The primary documents governing the conduct of the PDP are the Quality Assurance Program Document (QAPD) (DOE/CBFO-94-1012) and the Waste Isolation Pilot Plant (WIPP) Waste Analysis Plan (WAP) contained in the Hazardous Waste Facility Permit (NM4890139088-TSDF) issued by the New Mexico Environment Department (NMED). The WAP requires participation in the PDP; the PDP must comply with the QAPD and the WAP. This plan implements the general requirements of the QAPD and the applicable requirements of the WAP for the Headspace Gas (HSG) PDP. Participating measurement facilities analyze blind audit samples of simulated TRU waste package headspace gases according to the criteria set by this PDP Plan. Blind audit samples (hereafter referred to as PDP samples) are used as an independent means to assess each measurement facility's compliance with the WAP quality assurance objectives (QAOs). To the extent possible, the concentrations of VOC analytes in the PDP samples encompass the range of concentrations anticipated in actual TRU waste package headspace gas samples. Analyses of headspace gases are required by the WIPP to demonstrate compliance with regulatory requirements. These analyses must be performed by measurement facilities that have demonstrated acceptable performance in this PDP. These analyses are referred to as WIPP analyses and the TRU waste package headspace gas samples on which they are performed are referred to as WIPP samples in this document

  6. 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.

  7. [Regulatory science: modern trends in science and education for pharmaceutical products].

    Science.gov (United States)

    Beregovykh, V V; Piatigorskaia, N V; Aladysheva, Zh I

    2012-01-01

    This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term--"regulatory science" which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).

  8. The path of least resistance: Regulatory resource depletion and the effectiveness of social influence techniques

    NARCIS (Netherlands)

    Janssen, L.; Fennis, B.M.; Pruyn, Adriaan T.H.; Vohs, Kathleen D.

    2008-01-01

    Two experiments examine the role of regulatory resource depletion in the effectiveness of social influence techniques aimed at inducing consumer compliance. They test the two-step hypothesis that a) responding to the initial request stage of an influence technique requires self-control, thereby

  9. STATE INSPECTION METHODOLOGY OF ENVIRONMENTAL REGULATORY ACTIVITY FOCUSED ON THE LIFE CYCLE PROCESSESES

    Directory of Open Access Journals (Sweden)

    Yuniey Quiala Armenteros

    2016-10-01

    Full Text Available The Cuban Environmental Regulatory Activity has on the Environmental State Inspection an instrument for control and monitoring of compliance of current legal standards regarding environmental protection and rational use of natural resources. In this research, a design methodology for effective implementation of environmental regulatory activity in Cuba directed to processes is proposed; based on the life cycle assessment and the applicable environmental management standards, including new performance indicators, which form a new tool based on scientific criterions for the Center of Environmental Inspection and Control.

  10. Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice.

    Science.gov (United States)

    McCarty, Lynn S; Borgert, Christopher J; Mihaich, Ellen M

    2012-07-01

    There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates. We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data. Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process.

  11. Compliance monitoring in business processes: Functionalities, application, and tool-support.

    Science.gov (United States)

    Ly, Linh Thao; Maggi, Fabrizio Maria; Montali, Marco; Rinderle-Ma, Stefanie; van der Aalst, Wil M P

    2015-12-01

    In recent years, monitoring the compliance of business processes with relevant regulations, constraints, and rules during runtime has evolved as major concern in literature and practice. Monitoring not only refers to continuously observing possible compliance violations, but also includes the ability to provide fine-grained feedback and to predict possible compliance violations in the future. The body of literature on business process compliance is large and approaches specifically addressing process monitoring are hard to identify. Moreover, proper means for the systematic comparison of these approaches are missing. Hence, it is unclear which approaches are suitable for particular scenarios. The goal of this paper is to define a framework for Compliance Monitoring Functionalities (CMF) that enables the systematic comparison of existing and new approaches for monitoring compliance rules over business processes during runtime. To define the scope of the framework, at first, related areas are identified and discussed. The CMFs are harvested based on a systematic literature review and five selected case studies. The appropriateness of the selection of CMFs is demonstrated in two ways: (a) a systematic comparison with pattern-based compliance approaches and (b) a classification of existing compliance monitoring approaches using the CMFs. Moreover, the application of the CMFs is showcased using three existing tools that are applied to two realistic data sets. Overall, the CMF framework provides powerful means to position existing and future compliance monitoring approaches.

  12. Compliance with children’s television food advertising regulations in Australia

    Science.gov (United States)

    2012-01-01

    Background 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. Results 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. Conclusions 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. PMID:23039855

  13. Compliance with children’s television food advertising regulations in Australia

    Directory of Open Access Journals (Sweden)

    Roberts Michele

    2012-10-01

    Full Text Available Abstract Background 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. Results 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. Conclusions 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.

  14. The Amsterdam Hip Protector Study: Compliance and determinants of compliance

    NARCIS (Netherlands)

    van Schoor, N.M.; Asma, G.; Smit, J.H.; Bouter, L.M.; Lips, P.T.A.M.

    2003-01-01

    Hip protectors appear to be effective in reducing the incidence of hip fractures. However, compliance is often poor. Therefore, the objective of this study was to examine the compliance and determinants of compliance with external hip protectors. A prospective study was performed in residents from

  15. Mapping Tax Compliance

    DEFF Research Database (Denmark)

    Boll, Karen

    2014-01-01

    Tax compliance denotes the act of reporting and paying taxes in accordance with the tax laws. Current social science scholarship on tax compliance can almost entirely be divided into behavioural psychology analyses and critical tax studies. This article, which presents two cases of how tax...... compliance is constructed, challenges the explanatory reaches of today's social science approaches, arguing that an alternative approach to understanding tax compliance is worthwhile exploring. This other choice of approach, inspired by actor–network theory (ANT), adopts a more practice-oriented focus...... that studies tax compliance where it takes place as well as what it is made of. Consequently, this article argues that tax compliance is a socio-material assemblage and that complying is a distributed action. The article concludes by highlighting how an ANT approach contributes to the further theoretical...

  16. Directory of certificates of compliance for radioactive materials packages. Volume 2, Revision 17: Certificates of compliance

    International Nuclear Information System (INIS)

    1994-10-01

    This directory contains a Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and a Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 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 themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

  17. 77 FR 16026 - Cargill Power Markets, LLC v. Public Service Company of New Mexico; Notice of Compliance Filing

    Science.gov (United States)

    2012-03-19

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL10-61-002] Cargill Power Markets, LLC v. Public Service Company of New Mexico; Notice of Compliance Filing Take notice that on March 12, 2012, Public Service Company of New Mexico and Cargill Power Markets, LLC submitted a...

  18. A Simple Device for Measuring Static Compliance of Lung-Thorax Combine

    Science.gov (United States)

    Sircar, Sabyasachi

    2015-01-01

    Explaining the concept of lung compliance remains a challenge to the physiology teacher because it cannot be demonstrated easily in human subjects and all attempts until now have used only simulation models. A simple device is described in the present article to measure the compliance of the "lung-thorax" combine in human subjects with…

  19. Directory of certificates of compliance for radioactive materials packages: Report of NRC approved quality assurance programs for radioactive material 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

  20. 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

  1. Regulatory control of radiation sources in the Philippines

    Energy Technology Data Exchange (ETDEWEB)

    Daroy, Rosita R

    1996-12-31

    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). Paper presented during the IAEA Regional (RCA) Workshop on System of Notification, Registration, Licensing, and Control of Radiation Sources and Installations, Jakarta, Indonesia, 24-28 April 1995. 6 refs., 2 figs., 12 tabs.

  2. Principle of accrual and compliance of income and expenses in accounting system

    Directory of Open Access Journals (Sweden)

    V.V. Travin

    2017-12-01

    Full Text Available The introduction of international accounting and financial reporting standards requires the deeper implementation of accounting principles, in particular, the principle of accrual and compliance costs. The current research has shown that its implementation helps to streamline the accounting process by reducing the need to verify the chosen methodology for compliance with other regulatory documents that regulate the peculiarities of accounting in various areas. The categories of «a system», «income» and «expenses» in the accounting system are investigated and their system characteristics are showed. The approach to realization of the principle of accrual and compliance of income and expenses in the accounting system is described and proposed. It involves the possibility of capitalizing costs in the value of stocks, non-current assets, in the form of receivables, or in the form of future periods. The capitalization of costs in value occurs when the costs are not considered as such, and are considered only as an increase in the asset, as an integral part of these or other values. The study takes into account the peculiarities of its influence on the methodology of accounting for financial results of the enterprise.

  3. Land Disposal Restrictions Treatment Standards: Compliance Strategies for Four Types of Mixed Wastes

    International Nuclear Information System (INIS)

    Fortune, W.B.; Ranek, N.L.

    2006-01-01

    This paper describes the unique challenges involved in achieving compliance with the Resource Conservation and Recovery Act (Public Law 94-580) Land Disposal Restrictions (LDR) treatment standards for four types of mixed wastes generated throughout the U.S. Department of Energy (DOE) complex: (1) radioactively contaminated lead acid batteries; (2) radioactively contaminated cadmium-, mercury-, and silver-containing batteries; (3) mercury-bearing mixed wastes; and (4) radioactive lead solids. For each of these mixed waste types, the paper identifies the strategy pursued by DOE's Office of Pollution Prevention and Resource Conservation Policy and Guidance (EH-43) in coordination with other DOE elements and the U.S. Environmental Protection Agency (EPA) to meet the compliance challenge. Specifically, a regulatory interpretation was obtained from EPA agreeing that the LDR treatment standard for wastes in the D008 'Radioactive Lead Solids' sub-category applies to radioactively contaminated lead acid batteries. For cadmium-, mercury-, and silver-containing batteries, generically applicable treatability variances were obtained from EPA approving macro-encapsulation as the alternative LDR treatment standard for all three battery types. Joint DOE/EPA technology demonstrations were pursued for mercury-bearing mixed wastes in an effort to justify revising the LDR treatment standards, which focus on thermal recovery of mercury for reuse. Because the demonstrations failed to produce enough supporting data for a rulemaking, however, EPA has recommended site-specific treatability variances for particular mercury-bearing mixed waste streams. Finally, DOE has filed an application for a determination of equivalent treatment requesting approval of container-based macro-encapsulation technologies as an alternative LDR treatment standard for radioactive lead solids. Information is provided concerning the length of time required to implement each of these strategies, and suggestions for

  4. ENHANCING VOLUNTARY COMPLIANCE BY REDUCING COMPLIANCE COSTS: A TAXPAYER SERVICE APPROACH

    OpenAIRE

    Glenn Jenkins; EDWIN FORLEMU

    1993-01-01

    In this paper an overview is made of the determinants of voluntary tax compliance. Unlike previous treatments of this subject, the cost of taxpayer compliance is considered as an important determinant of overall level of voluntary compliance in a country. A number of ways that tax authorities reduce compliance are discussed, and the most common uses of information technology in providing taxpayer service is described. Finally, the paper considers some of the ways that such activities might be...

  5. Regulatory T Cells: Potential Target in Anticancer Immunotherapy

    Directory of Open Access Journals (Sweden)

    Chi-Mou Juang

    2007-09-01

    Full Text Available The concept of regulatory T cells was first described in the early 1970s, and regulatory T cells were called suppressive T cells at that time. Studies that followed have demonstrated that these suppressive T cells negatively regulated tumor immunity and contributed to tumor growth in mice. Despite the importance of these studies, there was extensive skepticism about the existence of these cells, and the concept of suppressive T cells left the center stage of immunologic research for decades. Interleukin-2 receptor α-chain, CD25, was first demonstrated in 1995 to serve as a phenotypic marker for CD4+ regulatory cells. Henceforth, research of regulatory T cells boomed. Regulatory T cells are involved in the pathogenesis of cancer, autoimmune disease, transplantation immunology, and immune tolerance in pregnancy. Recent evidence has demonstrated that regulatory T cellmediated immunosuppression is one of the crucial tumor immune evasion mechanisms and the main obstacle of successful cancer immunotherapy. The mechanism and the potential clinical application of regulatory T cells in cancer immunotherapy are discussed.

  6. GMOs in animal agriculture: time to consider both costs and benefits in regulatory evaluations.

    Science.gov (United States)

    Van Eenennaam, Alison L

    2013-09-25

    In 2012, genetically engineered (GE) crops were grown by 17.3 million farmers on over 170 million hectares. Over 70% of harvested GE biomass is fed to food producing animals, making them the major consumers of GE crops for the past 15 plus years. Prior to commercialization, GE crops go through an extensive regulatory evaluation. Over one hundred regulatory submissions have shown compositional equivalence, and comparable levels of safety, between GE crops and their conventional counterparts. One component of regulatory compliance is whole GE food/feed animal feeding studies. Both regulatory studies and independent peer-reviewed studies have shown that GE crops can be safely used in animal feed, and rDNA fragments have never been detected in products (e.g. milk, meat, eggs) derived from animals that consumed GE feed. Despite the fact that the scientific weight of evidence from these hundreds of studies have not revealed unique risks associated with GE feed, some groups are calling for more animal feeding studies, including long-term rodent studies and studies in target livestock species for the approval of GE crops. It is an opportune time to review the results of such studies as have been done to date to evaluate the value of the additional information obtained. Requiring long-term and target animal feeding studies would sharply increase regulatory compliance costs and prolong the regulatory process associated with the commercialization of GE crops. Such costs may impede the development of feed crops with enhanced nutritional characteristics and durability, particularly in the local varieties in small and poor developing countries. More generally it is time for regulatory evaluations to more explicitly consider both the reasonable and unique risks and benefits associated with the use of both GE plants and animals in agricultural systems, and weigh them against those associated with existing systems, and those of regulatory inaction. This would represent a shift away

  7. Types of suggestibility: Relationships among compliance, indirect, and direct suggestibility.

    Science.gov (United States)

    Polczyk, Romuald; Pasek, Tomasz

    2006-10-01

    It is commonly believed that direct suggestibility, referring to overt influence, and indirect suggestibility, in which the intention to influence is hidden, correlate poorly. This study demonstrates that they are substantially related, provided that they tap similar areas of influence. Test results from 103 students, 55 women and 48 men, were entered into regression analyses. Indirect suggestibility, as measured by the Sensory Suggestibility Scale for Groups, and compliance, measured by the Gudjonsson Compliance Scale, were predictors of direct suggestibility, assessed with the Barber Suggestibility Scale. Spectral analyses showed that indirect suggestibility is more related to difficult tasks on the BSS, but compliance is more related to easy tasks on this scale.

  8. Magnified Bacteria Powerful Motivator for Hand Hygiene Compliance.

    Science.gov (United States)

    Gregory, Ashley

    2016-08-01

    Infection prevention specialists at Henry Ford Hospital in Detroit have found that showing healthcare workers magnified pictures of bacteria found ontheir hands and in their surrounding units can be a powerful motivator for improved hand hygiene compliance. When tested in four units during a one-month period, the intervention boosted hand hygiene compliance by an average of 24%. Investigators note that to be successful, the intervention must be paired with an effective compliance monitoring program. For the study, investigators visited each unit twice per week, during which they would swab various items as well as employees' hands using and adenosine triphosphate (ATP) meter, a hand-held device that measures living organisms. During each unit visit, infection prevention specialists would show unit personnel pictures from a compilation of 12 magnified images of bacteria that had been lifted from the unit. This was to demonstrate what the bacteria would look like under a microscope. The unsavory pictures produced immediate increases in had hygiene compliance, and prompted healthcare workers to see who could produce the best ATP meter readings on subsequent infection prevention specialist visits.

  9. Perspectives on compliance: non-compliance with environmental licenses in the Netherlands

    NARCIS (Netherlands)

    van Snellenberg, A.H.L.M.; van de Peppel, R.A.

    2002-01-01

    Compliance with environmental law is not self-evident. In many instances enforcement of environmental regulations is a necessary means for achieving compliance. Assuming that an enforcement strategy, in order to be effective, has to fit the type of non-compliance, we integrate six different

  10. Criminal Compliance

    Directory of Open Access Journals (Sweden)

    Cristina Antonella Andretta

    2015-10-01

    The article discusses the concepts of both compliance and criminal compliance, its main components and structure as well as the main rules relating to its global application, and finally his emergence in the Ecuadorian legal system.

  11. 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

  12. Regulatory difficulties in a developing country

    International Nuclear Information System (INIS)

    Jacobs, W.R. Jr.

    1978-01-01

    The regulatory agency assigned the task of regulating the initial entry into the field of nuclear power generation by a developing country has a very difficult job. Based on the authors' experience during the start-up and initial operation of Ko-Ri Unit I, the first power reactor in the Republic of Korea, observations on regulatory difficulties and recommendations for improved regulatory effectiveness are offered. The problem areas can be loosely grouped into three general categories: (1) Lack of adequate technical knowledge which is the basis for all effective regulation; (2) Difficulties with understanding and utilization of the required regulatory documentation; (3) Failure to establish the proper regulatory environment. Examples are cited from actual experience during the Ko-Ri Unit I start-up to demonstrate the impact that regulatory activities can have on a plant construction and testing programme. The problems encountered are not unique to developing countries but also exist in the United States of America. Recommendations are offered which should be beneficial to either newly formed regulatory agencies or agencies wishing to improve their abilities and effectiveness. These include: (1) Additional training of regulatory inspectors in plant operations; (2) Additional experience gained by participation in regulatory activities in other countries; (3) Increased attention given to regulatory documents, especially plant technical specifications; (4) Establishment of formal lines of communication between the utility and the regulatory agency; (5) Clear definition of regulatory responsibilities to avoid areas of overlapping jurisdiction; (6) Active participation by the regulatory staff very early in the project. It is hoped that these and other recommendations offered will greatly improve regulatory effectiveness and at the same time demonstrate that when the decision is made to 'go nuclear', a strong commitment must be made to develop and support a technically

  13. Regulatory control and management of radioactive materials in the Philippines

    International Nuclear Information System (INIS)

    Borras, A.M.; Parami, V.K.; Domondon, D.B.

    2001-01-01

    The Philippine Nuclear Research Institute (PNRI) by virtue of Republic Act 2067, as amended, Republic Act 5207 and Executive Order 128 (1987), was mandated to promote, advance and regulate the safe and peaceful applications of nuclear science and technology in the Philippines. The PNRI was formerly the Philippine Atomic Energy Commission, established in 1958. This report aims to share the information and experience of PNRI as a regulatory authority on the administrative, technical and managerial aspects to ensure the safety and security of radioactive material in the country. It describes the country's regulatory framework, operational experiences, international co-operation including reporting system and database, and radiological safety assessment and compliance monitoring. It also briefly discusses the current development of the country's radiological emergency response plan and the radiation protection services offered by the PNRI. In the discussion and recommendations, some of the results of the regulatory information conferences conducted with the end-users are enumerated. (author)

  14. Improving regulatory oversight of maintenance programs

    International Nuclear Information System (INIS)

    Cook, S.

    2008-01-01

    Safe nuclear power plant operation requires that risks due to failure or unavailability of Structures, Systems and Components (SSCs) be minimized. Implementation of an effective maintenance program is a key means for achieving this goal. In its regulatory framework, the important relationship between maintenance and safety is acknowledged by the CNSC. A high level maintenance program requirement is included in the Class I Facilities Regulations. In addition, the operating licence contains a condition based on the principle that the design function and performance of SSCs needs to remain consistent with the plant's design and analysis documents. Nuclear power plant licensees have the primary responsibility for safe operation of their facilities and consequently for implementation of a successful maintenance program. The oversight role of the Canadian Nuclear Safety Commission (CNSC) is to ensure that the licensee carries out that responsibility. The challenge for the CNSC is how to do this consistently and efficiently. Three opportunities for improvement to regulatory maintenance oversight are being pursued. These are related to the regulatory framework, compliance verification inspection activities and monitoring of self-reporting. The regulatory framework has been improved by clarifying expectations through the issuance of S-210 'Maintenance Programs for Nuclear Power Plants'. Inspection activities have been improved by introducing new maintenance inspections into the baseline program. Monitoring is being improved by making better use of self-reported and industry produced maintenance related performance indicators. As with any type of program change, the challenge is to ensure the consistent and optimal application of regulatory activities and resources. This paper is a summary of the CNSC's approach to improving its maintenance oversight strategy. (author)

  15. 75 FR 58464 - Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing and Immediate Effectiveness of...

    Science.gov (United States)

    2010-09-24

    ...--NYSE Amex Equities (Anti-Money Laundering Compliance Program) replaced old Rule 445--NYSE Amex Equities...-Regulatory Organizations; NYSE Amex LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change... solicited or received with respect to the proposed rule change. III. Date of Effectiveness of the Proposed...

  16. Quality assurance evolution at Laguna Verde Nuclear Power Plant Unit 1 and 2, regulatory aspects

    International Nuclear Information System (INIS)

    Leon Martinez, Cenobia

    1996-01-01

    Quality Assurance (QA) in Mexico started with the construction of the Laguna Verde Nuclear Power Plant. The Nuclear Regulatory Body, based in the adopted regulation, required the use of Quality Assurance in the design, construction and operation of the Plant. This paper describes the evolution of QA from its beginnings, through its developing phase up to this time, and shows the role of the Regulatory Body, which has participated actively in the implantation of QA in a properly manner, enforcing the utility in avoiding deviations and non-compliancies with the established regulation. (author)

  17. Directory of Certificates of Compliance for Radioactive Materials Packages

    International Nuclear Information System (INIS)

    1993-10-01

    This directory contains Certificates of Compliance (Volume 2), for NRC Approved Packages. The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 173.471 and 10 CFR Part 71, is applicable. In satisfying the requirements of Section 71.12, it is the responsibility of the licensees to insure themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

  18. Directory of certificates of compliance for radioactive materials packages

    International Nuclear Information System (INIS)

    1991-10-01

    This directory contains Certificates of Compliance (Volume 2) for Radioactive Materials Packages. The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 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 themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

  19. 40 CFR 63.1453 - How do I demonstrate continuous compliance with the emission limitations, work practice standards...

    Science.gov (United States)

    2010-07-01

    ... responsible official in the next semiannual compliance report. (d) Venturi wet scrubbers. For each venturi wet...; (2) Inspect and maintain each venturi wet scrubber CPMS according to § 63.1452(c) and recording all... device other than a baghouse or venturi wet scrubber subject to the operating limits for site-specific...

  20. Accounting for Technological Change in Regulatory Impact Analyses: The Learning Curve Technique

    Energy Technology Data Exchange (ETDEWEB)

    Taylor, Margaret [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Fujita, K. Sydny [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States)

    2013-04-30

    Regulatory impact assessment is formally required by the U.S. and many other nations in order to help governments weigh the costs and benefits of proposed regulations, particularly as they compare to those of alternative actions and other government priorities. 1 One of the “best practices” of regulatory impact assessments, as established by the OECD, is to use estimates of costs that are grounded in economic theory. Economic theory indicates that changes in compliance costs should be expected over time as a result of factors related to technological innovation. But many U.S. regulatory impact assessments have traditionally employed a practice that is in conflict with this expectation: they take current estimates of the costs of complying with a proposed regulation and project that those costs will remain unchanged over the full time period that the regulation would be in effect.

  1. 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)

  2. Review of the performance assessment in the WIPP draft compliance application

    International Nuclear Information System (INIS)

    Lee, W.W.L.

    1996-01-01

    On March 31, 1995, the U.S. Department of Energy (USDOE) filed a draft compliance certification application (DCCA) with the U.S. Environmental Protection Agency (USEPA) to show the Waste Isolation Pilot Plant's compliance with the USEPA's environmental standards for disposal of high-level and transuranic waste. Demonstration of compliance is by a performance assessment. This paper is an early review of the performance assessment in the draft application, by the Environmental Evaluation Group, an oversight group. The performance assessment in the draft application is incomplete. Not all relevant scenarios have been analyzed. The calculation of potential consequences often does not use experimental data but rather estimates by workers developing additional data. The final compliance application, scheduled for October 1996, needs to consider additional scenarios, and be fully based on experimental data

  3. Guidelines on how to meet the requirement to keep all exposures as low as reasonably achievable. Regulatory guide

    International Nuclear Information System (INIS)

    1997-01-01

    The purpose of Regulatory Guide G-129 (E) is to provide Atomic Energy Control Board (AECB) licensees with guidelines on how to meet the forthcoming AECB regulatory requirement to keep doses received by workers and members of the public As Low As Reasonably Achievable (ALARA), social and economic factors taken into account. it is realized that the scope for realistic dose reductions will vary depending on the nature of the licensed activity. Therefore, criteria are given in section D for determining if doses can be deemed to be as low as reasonably achievable without further evaluation. The elements that the AECB considers to be essential in the approach to ALARA are described in section E and are summarized as follows: a demonstrated management commitment to the ALARA principle; the implementation of ALARA through a licensee's organization and management, provision of resources, training, establishment of action levels, documentation and other measures; and regular operational reviews. The above elements will be the focus of any AECB assessment to verify compliance with the requirement to keep radiation exposures as low as reasonably achievable. (author)

  4. Directory of Certificates of Compliance for Radioactive-Materials Packages. Summary report of NRC approved quality assurance programs for radioactive material 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

  5. DOD Business Systems Modernization: Key Navy Programs' Compliance with DOD's Federated Business Enterprise Architecture Needs to be Adequately Demonstrated

    National Research Council Canada - National Science Library

    Hite, Randolph C; Lakhmani, Neela; Barkakati, Nabajyoti; Doherty, Neil; Glover, Nancy; Longcore, Emily; Holland, Michael; Le, Anh; Leiling, Josh; McCracken, Lee; Srikanth, Sushmita

    2008-01-01

    .... In particular, the programs BEA compliance assessments did not: * Include all relevant architecture products, such as products that specify the technical standards needed to promote interoperability among related systems...

  6. 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)

  7. 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

  8. Proximal and distal effects of play on child compliance with a brain-injured parent.

    OpenAIRE

    Ducharme, J M; Rushford, N

    2001-01-01

    Individuals with brain injury may experience severe cognitive and other impairments. For brain-injured parents, such deficits may be associated with child behavior problems, including noncompliance. We assessed the effects of a play period conducted by a brain-injured father on the compliance of his son, who had become uncooperative with his father after the injury. The child consistently demonstrated improved compliance during proximal and distal compliance sessions that followed father-son ...

  9. Directory of certificates of compliance for radioactive materials packages

    International Nuclear Information System (INIS)

    1989-10-01

    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 each package design and approved QA programs prior to the publication date of the directory. Shipments of radioactive material utilizing these packages must be in accordance with the provisions of 49 CFR section 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 themselves that they have a copy of the current approval and conduct their transportation activities in accordance with a Nuclear Regulatory Commission approved quality assurance program

  10. Formalizing and appling compliance patterns for business process compliance

    NARCIS (Netherlands)

    Elgammal, A.; Turetken, O.; van den Heuvel, W.; Papazoglou, M.

    2016-01-01

    Today’s enterprises demand a high degree of compliance of business processes to meet diverse regulations and legislations. Several industrial studies have shown that compliance management is a daunting task, and organizations are still struggling and spending billions of dollars annually to ensure

  11. Formalizing and applying compliance patterns for business process compliance

    NARCIS (Netherlands)

    Elgammal, A.F.S.A.; Türetken, O.; van den Heuvel, W.J.A.M.; Papazoglou, M.

    Today’s enterprises demand a high degree of compliance of business processes to meet diverse regulations and legislations. Several industrial studies have shown that compliance management is a daunting task, and organizations are still struggling and spending billions of dollars annually to ensure

  12. Diagnostic information for compliance checking of temporal compliance requirements

    NARCIS (Netherlands)

    Ramezani Taghiabadi, E.; Fahland, D.; Dongen, van B.F.; Aalst, van der W.M.P.; Salinesi, C.; Norrie, M.C.; Pastor, O.

    2013-01-01

    Compliance checking is gaining importance as today’s organizations need to show that operational processes are executed in a controlled manner while satisfying predefined (legal) requirements or service level agreements. Deviations may be costly and expose an organization to severe risks. Compliance

  13. Federal Energy Regulatory Commission fiscal year 1997 annual financial statements

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-02-24

    This report presents the results of the independent certified public accountants` audit of the Federal Energy Regulatory commission`s statements of financial position, and the related statements of operations and changes in net position. The auditors` work was conducted in accordance with generally accepted government auditing standards. An independent public accounting firm conducted the audit. The auditors` reports on the Commission`s internal control structure and compliance with laws and regulations disclosed no reportable conditions or instances of noncompliance.

  14. Compliance matrix for the mixed waste disposal facilities, Trenches 31 ampersand 34, burial ground 218-W-5

    International Nuclear Information System (INIS)

    Carlyle, D.W.

    1994-01-01

    The purpose of the Trench 31 ampersand 34 Mixed Waste Disposal Facility Compliance Matrix is to provide objective evidence of implementation of all regulatory and procedural-institutional requirements for the disposal facilities. This matrix provides a listing of the individual regulatory and procedural-institutional requirements that were addressed. Subject matter experts reviewed pertinent documents that had direct or indirect impact on the facility. Those found to be applicable were so noted and listed in Appendix A. Subject matter experts then extracted individual requirements from the documents deemed applicable and listed them in the matrix tables. The results of this effort are documented in Appendix B

  15. For a dollar, would you. . .? How (we think) money affects compliance with our requests

    DEFF Research Database (Denmark)

    Bohns, Vanessa K.; Newark, D. A.; Xu, Amy Z.

    2016-01-01

    Research has shown a robust tendency for people to underestimate their ability to get others to comply with their requests. In five studies, we demonstrate that this underestimation-of-compliance effect is reduced when requesters offer money in exchange for compliance. In Studies 1 and 2, partici...

  16. Report on the establishment and operation of the Federal Energy Regulatory Commission's Daycare Center

    Energy Technology Data Exchange (ETDEWEB)

    1991-09-16

    We have completed an inspection of the Federal Energy Regulatory Commission's (FERC) Daycare Center (Center). The purpose of the inspection was to review for efficiency, economy and compliance with laws and regulations, FERC's establishment and operation of the Center. The inspection objectives were to review: (1) FERC's compliance with Federal laws and requirements of the General Services Administration and the District of Columbia; (2) the source and amount of funds for establishing and operating the Center; and (3) the organizational relationships between FERC, the Center and the contractor operating the Center.

  17. Defending public interests in private lands: compliance, costs and potential environmental consequences of the Brazilian Forest Code in Mato Grosso.

    Science.gov (United States)

    Stickler, Claudia M; Nepstad, Daniel C; Azevedo, Andrea A; McGrath, David G

    2013-06-05

    Land-use regulations are a critical component of forest governance and conservation strategies, but their effectiveness in shaping landholder behaviour is poorly understood. We conducted a spatial and temporal analysis of the Brazilian Forest Code (BFC) to understand the patterns of regulatory compliance over time and across changes in the policy, and the implications of these compliance patterns for the perceived costs to landholders and environmental performance of agricultural landscapes in the southern Amazon state of Mato Grosso. Landholdings tended to remain in compliance or not according to their status at the beginning of the study period. The perceived economic burden of BFC compliance on soya bean and beef producers (US$3-5.6 billion in net present value of the land) may in part explain the massive, successful campaign launched by the farm lobby to change the BFC. The ecological benefits of compliance (e.g. greater connectivity and carbon) with the BFC are diffuse and do not compete effectively with the economic benefits of non-compliance that are perceived by landholders. Volatile regulation of land-use decisions that affect billions in economic rent that could be captured is an inadequate forest governance instrument; effectiveness of such regulations may increase when implemented in tandem with positive incentives for forest conservation.

  18. 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

    2016-10-01

    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 disorder and 40 matched typically developing preschoolers, during separate interactions with mother and father, while engaging in two paradigms: toy pick-up and delayed gratification, which tap the "do" and "don't" aspects of self-regulated socialization at this age. Parents' disciplinary style was micro-coded from the two paradigms and child temperament was parent reported. Compared to their typically developing peers, children with autism spectrum disorder showed more noncompliance and less self-regulated compliance to parental demands and prohibitions and greater temperamental difficulties across several domains. No group differences were found in parental disciplinary style. Child self-regulated compliance was associated with parental supportive disciplinary style and with child attention focusing. Findings highlight the importance of parental supportive presence in structuring the development of socialization in children with autism spectrum disorder. Implications for parent-child emotion regulation interventions are discussed. © The Author(s) 2015.

  19. Demonstrating compliance with WAPS 1.3 in the Hanford waste vitrification plant process

    Energy Technology Data Exchange (ETDEWEB)

    Bryan, M.F.; Piepel, G.F.; Simpson, D.B.

    1996-03-01

    The high-level waste (HLW) vitrification plant at the Hanford Site was being designed to immobilize transuranic and high-level radioactive waste in borosilicate glass. This document describes the statistical procedure to be used in verifying compliance with requirements imposed by Section 1.3 of the Waste Acceptance Product Specifications (WAPS, USDOE 1993). WAPS 1.3 is a specification for ``product consistency,`` as measured by the Product Consistency Test (PCT, Jantzen 1992b), for each of three elements: lithium, sodium, and boron. Properties of a process batch and the resulting glass are largely determined by the composition of the feed material. Empirical models are being developed to estimate some property values, including PCT results, from data on feed composition. These models will be used in conjunction with measurements of feed composition to control the HLW vitrification process and product.

  20. Regulatory focus in groupt contexts

    NARCIS (Netherlands)

    Faddegon, Krispijn Johannes

    2009-01-01

    The thesis examines the influence of group processes on the regulatory focus of individual group members. It is demonstrated that the group situation can affect group members' regulatory focus both in a top-down fashion (via the identitiy of the group) and in a bottom-up fashion (emerging from the

  1. 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)

  2. Environmental assessment of ground-water compliance activities at the Uranium Mill Tailings Site, Spook, Wyoming

    International Nuclear Information System (INIS)

    1997-02-01

    This report assesses the environmental impacts of the Uranium Mill Tailings Site at Spook, Wyoming on ground water. DOE previously characterized the site and monitoring data were collected during the surface remediation. The ground water compliance strategy is to perform no further remediation at the site since the ground water in the aquifer is neither a current nor potential source of drinking water. Under the no-action alternative, certain regulatory requirements would not be met

  3. Use and application of 'best estimate plus uncertainty' methods. A regulatory view

    International Nuclear Information System (INIS)

    Mendizabal, Rafael; Pelayo, Fernando

    2013-01-01

    Regulatory environment is characterized by its prevention to change. Any move has to be solidly founded. Application in licensing of Best Estimate Plus Uncertainty (BEPU) methods is not an exception. Typically a fully deterministic approach as described in IAEA SSG-2 is used for design bases accident analyses in current Nuclear Power Plants. In recent years the use of BEPU methodologies is gaining favor in the nuclear technology community as a way to optimize design and operation while preserving full compliance with applicable regulation. This paper has its focus on the regulatory relevance of the use of BEPU in licensing practices. A regulatory analysis describing the rationale of the evolution from classic deterministic methods to BEPU as well as a selected set of topics around the implications of the use of BEPU methods is shown. To finalize some conclusions and thoughts of possible further developments of these methods are drawn. (authors)

  4. 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.

  5. 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

  6. Some aspects in the compliance with the Japanese radiation protection regulations

    International Nuclear Information System (INIS)

    Yamamoto, Hideaki; Mizushita, Seiichi

    2007-01-01

    This paper gives an overview of the major subjects in the recent amendments to the Japanese radiation protection regulations. These are related to the scope of the application of regulations: exclusion, exemption and clearance. The Radiological Hazards Prevention Law has modified the legal definition of 'radioactive materials'. The Reactors Control Law has been amended to establish clearance levels for releasing radioactive materials from regulatory control. The Japanese government has a plan to develop guidelines for exclusion and exemption of certain types of naturally-occurring radioactive materials (NORM). Some aspects in the compliance with the regulations are addressed. (author)

  7. Continuous improvement of the regulatory framework for the control of medical exposure

    International Nuclear Information System (INIS)

    Larcher, Ana M.; Ortiz Lopez, Pedro; Arias, Cesar; Marechal, Maria H.; Hernandez Alvarez, Ramon; Ferrer Garcia, Natividad; Castaneda Mucino, Antonia; Faller, Blanca

    2008-01-01

    One of the key elements to guide the improvement of the regulatory control is the availability of a self-assessment tool for regulatory performance. Although there is general guidance on self-assessment for regulators and users (IAEA), there is a need for more specific advice on how to address challenges and difficulties faced by regulatory bodies, when regulating radiation protection of patients. Examples of these challenges are the need for regulatory initiatives, in cooperation with health and education authorities, professional bodies and equipment suppliers, and to put in place necessary elements that are beyond responsibility of individual user of radiation, to enable them compliance with safety standards. Purpose: Within the programme of the Ibero American Forum of Nuclear and Radiation Safety Regulatory Organizations, a project to develop such a self-assessment tool for the regulatory control of medical exposure has been designed. Method: National experiences in transposing and enforcing the international radiation safety standards, as to how the requirements are included in national regulations are reviewed. Further, difficulties to the implementation of safety requirements are analyzed and a self-assessment approach and possible regulatory solutions a are presented. Results and discussion: In this study the following documents are being produced: 1) transposition of international requirements into national regulations in the six countries of the Forum, 2) difficulties to implement and enforce the requirements, 3) guidance on self-assessment of regulatory framework for medical exposure, 4) suggested contribution to the revision of international radiation safety standards. (author)

  8. Public Perceptions of Regulatory Costs, Their Uncertainty and Interindividual Distribution.

    Science.gov (United States)

    Johnson, Branden B; Finkel, Adam M

    2016-06-01

    Public perceptions of both risks and regulatory costs shape rational regulatory choices. Despite decades of risk perception studies, this article is the first on regulatory cost perceptions. A survey of 744 U.S. residents probed: (1) How knowledgeable are laypeople about regulatory costs incurred to reduce risks? (2) Do laypeople see official estimates of cost and benefit (lives saved) as accurate? (3) (How) do preferences for hypothetical regulations change when mean-preserving spreads of uncertainty replace certain cost or benefit? and (4) (How) do preferences change when unequal interindividual distributions of hypothetical regulatory costs replace equal distributions? Respondents overestimated costs of regulatory compliance, while assuming agencies underestimate costs. Most assumed agency estimates of benefits are accurate; a third believed both cost and benefit estimates are accurate. Cost and benefit estimates presented without uncertainty were slightly preferred to those surrounded by "narrow uncertainty" (a range of costs or lives entirely within a personally-calibrated zone without clear acceptance or rejection of tradeoffs). Certain estimates were more preferred than "wide uncertainty" (a range of agency estimates extending beyond these personal bounds, thus posing a gamble between favored and unacceptable tradeoffs), particularly for costs as opposed to benefits (but even for costs a quarter of respondents preferred wide uncertainty to certainty). Agency-acknowledged uncertainty in general elicited mixed judgments of honesty and trustworthiness. People preferred egalitarian distributions of regulatory costs, despite skewed actual cost distributions, and preferred progressive cost distributions (the rich pay a greater than proportional share) to regressive ones. Efficient and socially responsive regulations require disclosure of much more information about regulatory costs and risks. © 2016 Society for Risk Analysis.

  9. Adolescents' Compliance-Resistance: Effects of Parents' Compliance Strategy and Gender.

    Science.gov (United States)

    White, Kim D.; And Others

    1989-01-01

    Examined choice of compliance-resisting behaviors among adolescents. Findings from 118 high school students revealed significant differences in resistance strategy the adolescent selected on basis of parent gender, adolescent gender, and compliance-gaining strategy (manipulation, nonnegotiation, emotional appeal, personal rejection, empathic…

  10. Compliance checking of data-aware and resource-aware compliance requirements

    NARCIS (Netherlands)

    Ramezani Taghiabadi, E.; Gromov, V.; Fahland, D.; Aalst, van der W.M.P.; Meersman, R.; Panetto, H.; Dillon, T.; Missikoff, M.; Liu, L.; Pastor, O.; Cuzzocrea, A.; Sllis, T.

    2014-01-01

    Compliance checking is gaining importance as today’s organizations need to show that their business practices are in accordance with predefined (legal) requirements. Current compliance checking techniques are mostly focused on checking the control-flow perspective of business processes. This paper

  11. Compliance status

    International Nuclear Information System (INIS)

    Black, D.G.

    1995-01-01

    This section of the 1994 Hanford Site Environmental Report summarizes the activities conducted to ensure that the Hanford Site is in compliance with federal environmental protection statutes and related Washington State and local environmental protection regulations and the status of Hanford's compliance with these requirements. Environmental permits required under the environmental protection regulations are discussed under the applicable statute

  12. 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)

  13. Demonstration of a performance assessment methodology for nuclear waste isolation in basalt formations

    International Nuclear Information System (INIS)

    Bonano, E.J.; Davis, P.A.

    1988-01-01

    This paper summarizes the results of the demonstration of a performance assessment methodology developed by Sandia National Laboratories, Albuquerque for the US Nuclear Regulatory Commission for use in the analysis of high-level radioactive waste disposal in deep basalts. Seven scenarios that could affect the performance of a repository in basalts were analyzed. One of these scenarios, normal ground-water flow, was called the base-case scenario. This was used to demonstrate the modeling capabilities in the methodology necessary to assess compliance with the ground-water travel time criterion. The scenario analysis consisted of both scenario screening and consequence modeling. Preliminary analyses of scenarios considering heat released from the waste and the alteration of the hydraulic properties of the rock mass due to loads created by a glacier suggested that these effects would not be significant. The analysis of other scenarios indicated that those changing the flow field in the vicinity of the repository would have an impact on radionuclide discharges, while changes far from the repository may not be significant. The analysis of the base-case scenario was used to show the importance of matrix diffusion as a radionuclide retardation mechanism in fractured media. The demonstration of the methodology also included an overall sensitivity analysis to identify important parameters and/or processes. 15 refs., 13 figs., 2 tabs

  14. 10 CFR 20.1202 - Compliance with requirements for summation of external and internal doses.

    Science.gov (United States)

    2010-01-01

    ... external and internal doses. (a) If the licensee is required to monitor under both §§ 20.1502 (a) and (b), the licensee shall demonstrate compliance with the dose limits by summing external and internal doses... compliance with the requirements for summation of external and internal doses by meeting one of the...

  15. 40 CFR 63.5890 - How do I calculate an organic HAP emissions factor to demonstrate compliance for continuous...

    Science.gov (United States)

    2010-07-01

    ... for Hazardous Air Pollutants: Reinforced Plastic Composites Production Testing and Initial Compliance... per year Oc=controlled oven organic HAP emissions, lbs per year R=total usage of neat resin plus, tpy G=total usage of neat gel coat plus, tpy (b) Averaging option. Use Equation 2 of this section to...

  16. DOE`s approach to groundwater compliance on the UMTRA project

    Energy Technology Data Exchange (ETDEWEB)

    Metzler, D. [Dept. of Energy, Washington, DC (United States); Gibb, J.P. [Geraghty and Miller, Inc. (United States); Glover, W.A. [Roy F. Weston, Inc. (United States)

    1993-03-01

    Compliance with the mandate of the Uranium Mill Tailings Radiation Control Act (UMTRCA) at Uranium Mill Tailings Remedial Action (UMTRA) Project sites requires implementation of a groundwater remedial action plan that meets the requirements of Subpart B of the US Environmental Protection Agency`s proposed groundwater protection standards (40 CFR 192). The UMTRA Groundwater Project will ensure that unacceptable current risk or potential risk to the public health, safety and the environment resulting from the groundwater contamination attributable to the UMTRA sites, is mitigated in a timely and cost-efficient manner. For each UMTRA processing site and vicinity property where contamination exists, a groundwater remedial action plan must be developed that identifies hazardous constituents and establishes acceptable concentration limits for the hazardous constituents as either (a) alternate concentration limits (ACL), (b) maximum concentration limits (MCLs), (c) supplemental standards, or (d) background groundwater quality levels. Project optimization is a strategy that will aggressively work within the current regulatory framework using all available options to meet regulatory requirements. This strategy is outlined within.

  17. Compliance status

    Energy Technology Data Exchange (ETDEWEB)

    Black, D.G.

    1995-06-01

    This section of the 1994 Hanford Site Environmental Report summarizes the activities conducted to ensure that the Hanford Site is in compliance with federal environmental protection statutes and related Washington State and local environmental protection regulations and the status of Hanford`s compliance with these requirements. Environmental permits required under the environmental protection regulations are discussed under the applicable statute.

  18. Performing compliance

    DEFF Research Database (Denmark)

    Wimmelmann, Camilla Lawaetz

    2017-01-01

    the local policy workers front-staged some practices in the implementation process and back-staged others. The local policy workers deliberately performed ‘guideline compliance’ by using information control and impression management techniques. The findings suggest that local guideline compliance should...... be regarded as a staged performance in which deliberate techniques are used to produce and manage certain impressions of compliance....

  19. Compliance with the consumption of iron and folate supplements by ...

    African Journals Online (AJOL)

    2017-09-03

    Sep 3, 2017 ... Table 2: Activities that takes place during antenatal visit. Responses ..... Indonesia demonstrated that compliance with the supple- mentation intake ... tion throughout the pregnancy and forgetfulness as the reasons. All these ...

  20. 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.

  1. Environmental surveillance and compliance at Los Alamos during 1996

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-09-01

    This report presents environmental data that characterize environmental performance and addresses compliance with environmental standards and requirements at Los Alamos National Laboratory (LANL or the Laboratory) during 1996. The Laboratory routinely monitors for radiation and for radioactive nonradioactive materials at Laboratory sites as well as in the surrounding region. LANL uses the monitoring results to determine compliance with appropriate standards and to identify potentially undesirable trends. Data were collected in 1996 to assess external penetrating radiation; quantities of airborne emissions; and concentrations of chemicals and radionuclides in ambient air, surface waters and groundwaters, the municipal water supply, soils and sediments, and foodstuffs. Using comparisons with standards and regulations, this report concludes that environmental effects from Laboratory operations are small and do not pose a demonstrable threat to the public, Laboratory employees, or the environment. Laboratory operations were in compliance with all major environmental regulations.

  2. Environmental surveillance and compliance at Los Alamos during 1996

    International Nuclear Information System (INIS)

    1997-09-01

    This report presents environmental data that characterize environmental performance and addresses compliance with environmental standards and requirements at Los Alamos National Laboratory (LANL or the Laboratory) during 1996. The Laboratory routinely monitors for radiation and for radioactive nonradioactive materials at Laboratory sites as well as in the surrounding region. LANL uses the monitoring results to determine compliance with appropriate standards and to identify potentially undesirable trends. Data were collected in 1996 to assess external penetrating radiation; quantities of airborne emissions; and concentrations of chemicals and radionuclides in ambient air, surface waters and groundwaters, the municipal water supply, soils and sediments, and foodstuffs. Using comparisons with standards and regulations, this report concludes that environmental effects from Laboratory operations are small and do not pose a demonstrable threat to the public, Laboratory employees, or the environment. Laboratory operations were in compliance with all major environmental regulations

  3. 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

  4. 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

  5. Regulatory analysis for final rule on nuclear power plant license renewal

    International Nuclear Information System (INIS)

    1991-12-01

    This regulatory analysis provides the supporting information for the final rule (10 CFR Part 54) that defines the Nuclear Regulatory Commission's requirements for renewing the operating licenses of commercial nuclear power plants. A set of four specific alternatives for the safety review of license renewal applications is defined and evaluated. These are: Alternative A-current licensing basis; Alternative B-extension of Alternative A to require assessment and managing of aging; Alternative C -- extension of Alternative B to require assessment of design differences against selected new-plant standards using probabilistic risk assessment; and Alternative D -- extension of Alternative B to require compliance with all new-plant standards. A quantitative comparison of the four alternatives in terms of impact-to-value ratio is presented, and Alternative B is the most cost-beneficial safety review alternative

  6. 40 CFR Table 8 to Subpart Wwww of... - Initial Compliance With Organic HAP Emissions Limits

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 12 2010-07-01 2010-07-01 true Initial Compliance With Organic HAP... Organic HAP Emissions Limits As specified in § 63.5860(a), you must demonstrate initial compliance with organic HAP emissions limits as specified in the following table: For . . . That must meet the following...

  7. Regulatory Framework and Radiation Protection as Basis for Evaluation

    International Nuclear Information System (INIS)

    Elegba, S.B.

    2010-01-01

    Regulatory Framework for Nuclear Safety and Radiation Protection International Instruments: Conventions; Safety Fundamentals; Codes of Conduct; Safety Requirements and Guide, and National Instruments:-Legislation; Regulations; Guidance Documents. The Sustainable Development Principle recognizes a duty to prevent undue burden and degradation of the environment for future generations. The prime responsibility for safety must rest with the person or organization responsible for facilities…that give rise to radiation risks” (IAEA Safety Fundamentals – SF-1). Compliance with regulations and requirements imposed by the Regulatory Body shall not relieve the organization of its prime responsibility for safety. The regulatory body shall establish and implement appropriate arrangements for a systematic approach to quality management which extend throughout the range of responsibilities and functions undertaken.”. The IAEA self-assessment model for a Regulatory Body is based on a three tier approach. This model is modular and can be used and adopted for implementation by any regulator at any stage of maturity “Start up”, “On the way”, “Mature” Small, medium size, big. The IAEA is required by its Statute to promote international cooperation while regulating safety is a national responsibility. However, radiation risks may transcend national borders and international cooperation that serves to promote and enhance safety globally by exchanging experience and by improving capabilities to control hazards, to prevent accidents, to respond to emergencies and to mitigate any harmful consequences

  8. Compliance and treatment satisfaction of post menopausal women treated for osteoporosis. Compliance with osteoporosis treatment

    Directory of Open Access Journals (Sweden)

    Huas Dominique

    2010-08-01

    Full Text Available Abstract Background Adherence to anti-osteoporosis treatments is poor, exposing treated women to increased fracture risk. Determinants of poor adherence are poorly understood. The study aims to determine physician- and patient- rated treatment compliance with osteoporosis treatments and to evaluate factors influencing compliance. Methods This was an observational, cross-sectional pharmacoepidemiological study with a randomly-selected sample of 420 GPs, 154 rheumatologists and 110 gynaecologists practicing in France. Investigators included post-menopausal women with a diagnosis of osteoporosis and a treatment initiated in the previous six months. Investigators completed a questionnaire on clinical features, treatments and medical history, and on patient compliance. Patients completed a questionnaire on sociodemographic features, lifestyle, attitudes and knowledge about osteoporosis, treatment compliance, treatment satisfaction and quality of life. Treatment compliance was evaluated with the Morisky Medication-taking Adherence Scale. Variables collected in the questionnaires were evaluated for association with compliance using multivariate logistic regression analysis. Results 785 women were evaluated. Physicians considered 95.4% of the sample to be compliant, but only 65.5% of women considered themselves compliant. The correlation between patient and physician perceptions of compliance was low (κ: 0.11 [95% CI: 0.06 to 0.16]. Patient-rated compliance was highest for monthly bisphosphonates (79.7% and lowest for hormone substitution therapy (50.0%. Six variables were associated with compliance: treatment administration frequency, perceptions of long-term treatment acceptability, perceptions of health consequences of osteoporosis, perceptions of knowledge about osteoporosis, exercise and mental quality of life. Conclusion Compliance to anti-osteoporosis treatments is poor. Reduction of dosing regimen frequency and patient education may be useful

  9. Civilian use transport of radioactive substances on public road. Volume 1: Shipment accreditation and approval requests. Guide Nr 7, Revision 2 of 15 February 2016. Volume 2: safety file of package models, European guide 'Package Design Safety Report'. Civilian use transport of radioactive packages or substances on public road. Volume 3: Compliance of package models not subject to accreditation. Guide Nr 7, Revision 7 of the 2015/11/13

    International Nuclear Information System (INIS)

    2016-01-01

    After having recalled the regulatory context and sanctions susceptible to be applied, the first volume presents the accreditation process for a package model: file content, tests programme, safety file, certification studies, documents to be produced, accreditation prorogation request, accreditation extension or package model modifications, instruction delays. Some peculiar cases are described. Models of accreditation certificate are provided, and obligations concerning packaging design, fabrication, use and maintenance are briefly discussed. The second volume is a European technical guide which is intended to assist in the preparation of the Package Design Safety Report (PDSR) to demonstrate compliance of a package design for the transport of radioactive material with the regulatory requirements. It covers package designs requiring competent authority approval, and also covers package designs not requiring competent authority approval. In its first two chapters, this document provides a generic structure and contents of a PDSR which applies to all package types. The contents are described in a comprehensive way to cover all important aspects. Some of these aspects may not be applicable to specific package type and details can be found in the annexes which provide further guidance for the scope of the contents of a PDSR, specifically for each package type. The third volume presents recommendations made by the ASN for all stakeholders to guarantee the compliance to regulation of package models which are 'not submitted to competent authority approval'. After an indication and a comment of the regulatory context, it presents requirements to be applied for the design of those package models, and then describes and comments the structure and content of a safety file for such package models (generalities, authorised contents, packaging description, safety demonstration, receipt, use and maintenance instruction, management system). The last part presents the

  10. 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...

  11. Environmental compliance in the petrochemical industry in the Sarnia area

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2005-04-01

    In February 2004, the Ontario Ministry of the Environment directed its Environmental SWAT Team to conduct a comprehensive inspection sweep of Sarnia's industrial sector to ensure that all facilities in that region were brought into compliance with environmental legislation. The primary focus was to inspect areas with the potential for future spills or unlawful discharges that could pose risks to human health or the environment. Legislative and regulatory gaps that could allow environmentally unsafe practices to exist at the facilities were also revealed. The inspection sweep involved comprehensive inspections of 35 petrochemical plant's air emissions, water discharges and spill prevention plans. SWAT officers examined waste management, laboratory operations and other areas that must meet environmental legislative requirements. Nearly all of the of facilities inspected during the sweep were found to be in non-compliance with one or more legislative or regulatory requirement. Common deficiencies included: no spill contingency or spill prevention plans; not having a Certificate of Approval for wastewater collection and treatment works or air emission control equipment; altering equipment, systems, processes, or structure contrary to the existing Certificate of Approval; and improper chemical handling, storage and identification. As a result of the inspection, 6 facilities were ordered to develop both a spill prevention plan and a spill contingency plan and 2 facilities were ordered to develop a spill prevention plan. SWAT officers have followed up to ensure that companies have taken appropriate corrective actions. The inspection revealed some of the sound practices undertaken at some facilities, such as containment; monitoring; prevention of discharge of contaminants to air or water; waste water and storm water treatment; contingency planning; and process hazard analysis of all key processes. refs., tabs., figs.

  12. 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

  13. 40 CFR 60.4335 - How do I demonstrate compliance for NOX if I use water or steam injection?

    Science.gov (United States)

    2010-07-01

    ... if I use water or steam injection? 60.4335 Section 60.4335 Protection of Environment ENVIRONMENTAL... compliance for NOX if I use water or steam injection? (a) If you are using water or steam injection to... monitor and record the fuel consumption and the ratio of water or steam to fuel being fired in the turbine...

  14. Continuous Improvement of the Regulatory Framework for the Control of Medical Exposure

    International Nuclear Information System (INIS)

    Larcher, A.M.; Ortiz lopez, Pedro; Arias, Cesar; Marechal, Maria H.; Hernandez Alvarez, Ramon; Ferrer Garcia, Natividad; Castaneda Mucino, Antonia; Faller, Blanca

    2011-01-01

    Background: One of the key elements to guide the improvement of the regulatory control is the availability of a self-assessment tool for regulatory performance. Although there is general guidance on self-assessment for regulators and users (IAEA), there is a need for specific advice on how to address challenges and difficulties faced by regulatory bodies, when regulating radiation protection of patients. Examples of these challenges are the need of regulatory initiatives, in cooperation with health and education authorities, professional bodies and equipment suppliers, and to put in place necessary elements that are beyond responsibility of individual users of radiation, to enable them compliance with safety standards. Purpose: within the programme of the Ibero American Forum of Nuclear and Radiation Safety Regulatory Organizations, a project to develop such a self assessment tool for the regulatory control of medical exposure has been designed. Method: national experiences in transposing and enforcing the international radiation safety standards, as to how the requirements are included in national regulations are reviewed. Further, difficulties to the implementation of safety requirements are included in national regulations are analyzed and a self assessment approach and possible regulatory solutions are presented. Results and discussion: in tis study the following documents are being produced: 1) Transposition of international requirements into national regulations in the six countries of the Forum, 2) difficulties to implement and enforce the requirements, 3) guidance on self assessment of regulatory framework for medical exposure, 4) suggested contribution to the revision of international radiation safety standards. (authors)

  15. Regulatory Oversight for New Projects - Challenges and Improvement in Regulation

    International Nuclear Information System (INIS)

    Lall, F.

    2016-01-01

    From inception, there has been rise in number of Nuclear Power Plants (NPP) even though very few accidents / events led to intermittent setbacks. However these accidents / events have posed challenges towards enhancement of safety and scope of regulation in all phases of NPP such as siting, design, construction, commissioning and decommissioning. It is essential to ensure compliance to these enhanced safety requirements during all phases of NPP. New and evolutionary reactors are under threshold for regulatory consideration world over. The variety of technologies and genres by themselves pose challenges to regulatory bodies. These challenges are to be addressed through systematic enhancement of the regulation including updating of regulatory documents. The paper touches upon some key elements to be considered towards such enhancement of regulation during all stages of NPP. These being; ensuring quality assurance, regulatory oversight especially over supply chain and contractors, counterfeit material specifically in case of international dealings, emergency handling in case of multi-unit site, feedback and associated enhancements from international events, construction experience database and feedback for safety enhancement, qualification and acceptance of first of a kind systems, regulatory enforcement specifically in case of imported reactors and maintaining interface between safety and security. Regulation in present context has become dynamic and Regulatory bodies need to continue enhancement of its current regulation taking into account the technological developments, feedback from construction, operation and accidents in the current fleet of plants. The paper touches upon some of these elements and highlights the challenges and improvements in regulation. (author)

  16. Compliance with Environmental Regulations through Complex Geo-Event Processing

    Directory of Open Access Journals (Sweden)

    Federico Herrera

    2017-11-01

    Full Text Available 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 data coming from autonomous sensors (e.g. reporting carbon emission in protected areas and from citizens providing information (e.g. illegal dumping in a voluntary way. Complex Event Processing (CEP technologies allow processing large amount of event data and detecting patterns from them. However, they do not provide native support for the geographic dimension of events which is essential for monitoring requirements which apply to specific geographic areas. This paper proposes a geospatial extension for CEP that allows monitoring environmental requirements considering the geographic location of the processed data. We extend an existing platform-independent, model-driven approach for CEP adding the geographic location to events and specifying patterns using geographic operators. The use and technical feasibility of the proposal is shown through the development of a case study and the implementation of a prototype.

  17. Environmental Compliance Guide

    International Nuclear Information System (INIS)

    1981-02-01

    The Guide is intended to assist Department of Energy personnel by providing information on the NEPA process, the processes of other environmental statutes that bear on the NEPA process, the timing relationships between the NEPA process and these other processes, as well as timing relationships between the NEPA process and the development process for policies, programs, and projects. This information should be helpful not only in formulating environmental compliance plans but also in achieving compliance with NEPA and various other environmental statutes. The Guide is divided into three parts with related appendices: Part I provides guidance for developing environmental compliance plans for DOE actions; Part II is devoted to NEPA with detailed flowcharts depicting the compliance procedures required by CEQ regulations and Department of Energy NEPA Guidelines; and Part III contains a series of flowcharts for other Federal environmental requirements that may apply to DOE projects

  18. Environmental Compliance Guide

    Energy Technology Data Exchange (ETDEWEB)

    None

    1981-02-01

    The Guide is intended to assist Department of Energy personnel by providing information on the NEPA process, the processes of other environmental statutes that bear on the NEPA process, the timing relationships between the NEPA process and these other processes, as well as timing relationships between the NEPA process and the development process for policies, programs, and projects. This information should be helpful not only in formulating environmental compliance plans but also in achieving compliance with NEPA and various other environmental statutes. The Guide is divided into three parts with related appendices: Part I provides guidance for developing environmental compliance plans for DOE actions; Part II is devoted to NEPA with detailed flowcharts depicting the compliance procedures required by CEQ regulations and Department of Energy NEPA Guidelines; and Part III contains a series of flowcharts for other Federal environmental requirements that may apply to DOE projects.

  19. Federal and state regulatory requirements for the D ampersand D of the Alpha-4 Building, Y-12 Plant, Oak Ridge, Tennessee

    International Nuclear Information System (INIS)

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

    1994-01-01

    The US Department of Energy (DOE) has begun the decontamination and decommissioning (D ampersand D) of Building 9201-4 (Alpha-4) at the Oak Y-12 Plant, Oak Ridge, Tennessee, The Alpha-4 Building was used from 1953--1962 to house a column exchange (Colex) process for lithium isotope separation. This process involved electrochemical and solvent extraction processes that required substantial quantities of mercury. Presently there is no law or regulation mandating decommissioning at DOE facilites or setting de minimis or ''below regulatory concern'' (BRC) radioactivity levels to guide decommissioning activities at DOE facilities. However, DOE Order 5820.2A, Chap. V (Decommissioning of Radioactively Contaminated Facilities), requires that the regulatory status of each project be identified and that technical engineering planning must assure D ampersand D compliance with all environmental regulations during cleanup activities. To assist in the performance of this requirement, this paper gives a brief overview of potential federal and state regulatory requirements related to D ampersand D activities at Alpha-4. Compliance with other federal, state, and local regulations not addressed here may be required, depending on site characterization, actual D ampersand D activities, and wastes generated

  20. 40 CFR 63.8802 - What methods must I use to demonstrate compliance with the emission limitation for loop slitter...

    Science.gov (United States)

    2010-07-01

    ... Hazardous Air Pollutants: Flexible Polyurethane Foam Fabrication Operations Testing and Initial Compliance... for each material used in your foam fabrication operations, you must use one of the options in... CFR part 63). You may use Method 311 for determining the mass fraction of HAP. Use the procedures...

  1. Compliance pluralisme and processes : Understanding compliance behavior in restaurants in China

    NARCIS (Netherlands)

    Wu, Y.

    2017-01-01

    This research aimed to offer a case study of dynamic compliance processes in selected Chinese restaurants with the main methods of participant observation and in-depth interviews. It applied an integrated and dynamic research approach, called descriptive analysis of compliance behavior, which

  2. Compliance to topical anti-glaucoma medications among patients at a tertiary hospital in North India

    Directory of Open Access Journals (Sweden)

    Ketaki Rajurkar

    2018-06-01

    Full Text Available Purpose: The present study aims to estimate the prevalence of non-compliance and improper drop administration technique among glaucoma patients and describe common obstacles to medication compliance. Methods: A hospital-based cross-sectional study, using standardized questionnaire and direct observation by study personnel was conducted among glaucoma patients aged 18 years and above at a tertiary care charitable eye hospital in North India. 151 consecutive glaucoma patients on medical therapy following up at the glaucoma clinics for at least 6 months were recruited. Non-compliance was defined as missing at-least one drop of medication per week and (or the inability to accurately describe the medication regimen. Study personnel also assessed drop administration technique during application of eye drops by patients treating ophthalmologist-provided information, including measures of disease stability. Factors such as socioeconomic status, presence of caregiver, and number of medications with their effect on compliance were studied using chi-square statistics. Results: Among 151 patients interviewed, around 49% of patients reported problems in using glaucoma medications, with 16% of them reporting total non-compliance. 35% of patients demonstrated improper drop administration technique. Forgetfulness was cited as the main reason for being non-compliant and had a significant association with non-compliance (P = 0.00. Paying patients were more compliant as compared to subsidized patients (P = 0.05. Disease was more stable in compliant patients compared to non-compliant patients (P = 0.05. No other factor had significant association with compliance (P > 0.05. Conclusions: Over 50% of the patients surveyed were non-compliant, and 35% demonstrated improper administration technique. Glaucoma patients should be educated on the importance of compliance and aids that minimize forgetfulness, and delivery systems facilitating the delivery of

  3. Development of regulatory policy for SMART-P

    Energy Technology Data Exchange (ETDEWEB)

    Lee, S. H.; Lee, Y. H.; Moo, Philip; Koh, B. J.; Son, M. K.; Han, G. H.; Kim, D. H. [Korea Association for Nuclear Technology, Daejeon (Korea, Republic of)

    2004-06-15

    KAERI promoted the construction of a research reactor, SMART-P, the reduced scale of SMART, with intent to demonstrate the safety and performance of SMART. According to this progress, the development of regulatory process for SMART-P became necessary. The establishment of regulatory policy, based on the current regulatory guidelines as well as technical aspect, became essential matters. Considering the on-going small and medium size reactors in near future, the selection of the appropriate measure in the existing regulatory process to SMART-P is very important. Thus the schematic study for the applicable licensing procedure and regulatory requirements suitable for SMART-P is required.

  4. Development of regulatory policy for SMART-P

    Energy Technology Data Exchange (ETDEWEB)

    Lee, S. H.; Moon, S. H.; Lee, Y. H.; Son, M. K.; Han, K. H.; Kim, D. H. [Korea Association for Nuclear Technology, Taejon (Korea, Republic of)

    2003-06-15

    KAERI promoted the construction of a research reactor, SMART-P, the reduced scale of SMART, with intent to demonstrate the safety and performance of SMART. According to this progress, the development of regulatory process for SMART-P became necessary. The establishment of regulatory policy, based on the current regulatory guidelines as well as technical aspect, became essential matters. Considering the on-going small and medium size reactors m near future, the selection of the appropriate measure in the existing regulatory process to SMART-P is very important. Thus the schematic study for the applicable licensing procedure and regulatory requirements suitable for SMART-P is required.

  5. Transport of radioactive material in Bangladesh: a regulatory perspective

    International Nuclear Information System (INIS)

    Mollah, A.S.

    2004-01-01

    Radioactive material is transported in Bangladesh in various types of packages and by different modes of transport. The transport of radioactive materials involves a risk both for the workers and members of the public. The safe transport of radioactive material is ensured in Bangladesh by compliance with Nuclear Safety and Radiation Control (NSRC) Act-93 and NSRC Rules-97. The Bangladesh Atomic Energy Commission (BAEC) is the competent authority for the enforcement of the NSRC act and rules. The competent authority has established regulatory control at each stage to ensure radiation safety to transport workers, members of general public and the environment. An overview is presented of the activities related to the transport of radioactive material in Bangladesh. In particular, the applicable legislation, the scope of authority and the regulatory functions of the competent authority are discussed. The categories of radioactive materials transported and the packaging requirements for the safe transport of these radioactive materials are also described. (author)

  6. Conflict Resolution in Chinese Adolescents' Friendship: Links with Regulatory Focus and Friendship Satisfaction.

    Science.gov (United States)

    Gao, Qin; Bian, Ran; Liu, Ru-de; He, Yili; Oei, Tian-Po

    2017-04-03

    It is generally acknowledged that people adopt different resolution strategies when facing conflicts with others. However, the mechanisms of conflict resolution are still unclear and under researched, in particular within the context of Chinese adolescents' same-sex friendship relations. Thus, the present study investigated the mediator role of conflict resolution strategies in the relationship between regulatory foci and friendship satisfaction for the first time. 653 Chinese adolescents completed the regulatory foci, conflict resolution style, and friendship satisfaction measures. The results of the structure equation modeling showed that while promotion focus was positively associated with problem-solving and compliance, prevention focus was positively associated with withdrawal and conflict engagement. In addition, problem-solving mediated the relationship between promotion focus and friendship satisfaction, and conflict engagement mediated the relationship between prevention focus and friendship satisfaction. These findings contribute to understanding Chinese adolescents' use of conflict resolution strategies as well as the relationship between regulatory foci and behavioral strategies in negative situations.

  7. 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

  8. Novel method to calculate pulmonary compliance images in rodents from computed tomography acquired at constant pressures

    International Nuclear Information System (INIS)

    Guerrero, Thomas; Castillo, Richard; Sanders, Kevin; Price, Roger; Komaki, Ritsuko; Cody, Dianna

    2006-01-01

    Our goal was to develop a method for generating high-resolution three-dimensional pulmonary compliance images in rodents from computed tomography (CT) images acquired at a series of constant pressures in ventilated animals. One rat and one mouse were used to demonstrate this technique. A pre-clinical GE flat panel CT scanner (maximum 31 line-pairs cm -1 resolution) was utilized for image acquisition. The thorax of each animal was imaged with breath-holds at 2, 6, 10, 14 and 18 cm H 2 O pressure in triplicate. A deformable image registration algorithm was applied to each pair of CT images to map corresponding tissue elements. Pulmonary compliance was calculated on a voxel by voxel basis using adjacent pairs of CT images. Triplicate imaging was used to estimate the measurement error of this technique. The 3D pulmonary compliance images revealed regional heterogeneity of compliance. The maximum total lung compliance measured 0.080 (±0.007) ml air per cm H 2 O per ml of lung and 0.039 (±0.004) ml air per cm H 2 O per ml of lung for the rat and mouse, respectively. In this study, we have demonstrated a unique method of quantifying regional lung compliance from 4 to 16 cm H 2 O pressure with sub-millimetre spatial resolution in rodents

  9. TELECOMMUNICATIONS AND BROADCASTING: A QUESTION OF REGULATORY DISSOCIATION

    Directory of Open Access Journals (Sweden)

    Chalini Torquato Gonçalves de Barros

    2009-08-01

    Full Text Available The legislation governing the communication in Brazil is marked by significant normative paradox between the telecommunication and broadcasting services, from the privatization of the sector at the time of President Fernando Henrique Cardoso. Among the factors that contribute to the establishment of such situation are practices of patronage, inherent in the Brazilian political culture. In the same manner, the communication sector of Brazil follows an opposite direction to the worldwide trend of technological and legislative convergence besides weakening the State with regard to the compliance of its regulatory role, especially because it is vulnerable to pressures from more influential sector actors.

  10. 40 CFR 63.8232 - What test methods and other procedures must I use to demonstrate initial compliance with the...

    Science.gov (United States)

    2010-07-01

    .... (e) During each test run for a by-product hydrogen stream and each test run for an end box... compliance with the emission limits? You must conduct a performance test for each by-product hydrogen stream, end box ventilation system vent, and mercury thermal recovery unit vent according to the requirements...

  11. Directory of certificates of compliance for radioactive materials packages. Volume 2, Revision 6

    International Nuclear Information System (INIS)

    1983-09-01

    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

  12. Development of derived investigation levels for use in internal dosimetry at the West Valley Demonstration Project

    International Nuclear Information System (INIS)

    Johnson, P.

    1991-01-01

    The objective was to determine if the routine intemal dosimetry program at the West Valley Demonstration Project is capable of meeting the performance objective of 1 mSv annual effective dose equivalent due to internal contamination. With the use of the computer code REMedy the annual effective dose equivalent is calculated. Some of the radionuclides of concern result in an annual effective dose equivalent that exceeds the performance objective. Although the results exceed the performance objective, in all but two cases they do not exceed the US DOE regulatory limits. In these instances the Th-232 and Am-241 were determined to exceed the committed dose equivalent limit to their limiting tissue. In order to document the potential missed dose for regulatory compliance, Sr-90 is used as an indicator for Th-232. For Am-241 an investigation as to whether or not the minimum detectable amount can be lowered is performed. The derived investigation levels as a result of this project are 4.9E3 Bq/lung count for Co-60, 2.2E4 Bq/lung count for Cs-137, 1.9 Bq/1 for Sr-90 and for radionuclides other than Sr-90 any value greater than or equal to three standard deviations above their net count is considered to require further investigation

  13. Parental compliance - an emerging problem in Liverpool community child health surveys 1991-2006

    Directory of Open Access Journals (Sweden)

    Koshy Gibby

    2012-04-01

    Full Text Available Abstract Background Compliance is a critical issue for parental questionnaires in school based epidemiological surveys and high compliance is difficult to achieve. The objective of this study was to determine trends and factors associated with parental questionnaire compliance during respiratory health surveys of school children in Merseyside between 1991 and 2006. Methods Four cross-sectional respiratory health surveys employing a core questionnaire and methodology were conducted in 1991, 1993, 1998 and 2006 among 5-11 year old children in the same 10 schools in Bootle and 5 schools in Wallasey, Merseyside. Parental compliance fell sequentially in consecutive surveys. This analysis aimed to determine the association of questionnaire compliance with variation in response rates to specific questions across surveys, and the demographic profiles for parents of children attending participant schools. Results Parental questionnaire compliance was 92% (1872/2035 in 1991, 87.4% (3746/4288 in 1993, 78.1% (1964/2514 in 1998 and 30.3% (1074/3540 in 2006. The trend to lower compliance in later surveys was consistent across all surveyed schools. Townsend score estimations of socio-economic status did not differ between schools with high or low questionnaire compliance and were comparable across the four surveys with only small differences between responders and non-responders to specific core questions. Respiratory symptom questions were mostly well answered with fewer than 15% of non-responders across all surveys. There were significant differences between mean child age, maternal and paternal smoking prevalence, and maternal employment between the four surveys (all p Conclusion Methodological differences or changes in socio-economic status of respondents between surveys were unlikely to explain compliance differences. Changes in maternal employment patterns may have been contributory. This analysis demonstrates a major shift in community parental

  14. 40 CFR 60.24 - Emission standards and compliance schedules.

    Science.gov (United States)

    2010-07-01

    ... energy input from all fuel except biomass if the unit is a boiler. Combustion turbine means: (1) An... been demonstrated, States may balance the emission guidelines, compliance times, and other information... energy input” in § 60.4102 of this chapter promulgated on October 19, 2007, provided that the State...

  15. Deadline Compliance Status Reports

    Data.gov (United States)

    Department of Housing and Urban Development — These monthly Deadline Compliance Status Reports assist Participating Jurisdictions and HUD Field Offices in monitoring compliance with the 2-year commitment and...

  16. 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

  17. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2008-01-01

    The aim of this paper is to show that regulatory risk is due to the discretionary behaviour of regulatory agencies, caused by a too extensive regulatory mandate provided by the legislator. The normative point of reference and a behavioural model of regulatory agencies based on the positive theory of regulation are presented. Regulatory risk with regard to the future behaviour of regulatory agencies is modelled as the consequence of the ex ante uncertainty about the relative influence of inter...

  18. Report for 2008 on electricity and natural-gas network operators: obedience to compliance programmes and independence. Report 2008

    International Nuclear Information System (INIS)

    2008-12-01

    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 2008 report about compliance programmes and independence of electricity and natural gas system operators. Contents: 1 - Obedience to compliance programmes: Assessment compared with 2007, Demands from CRE; 2 - The independence of system operators: Transmission system operators, Distribution system operators, Comments common to both transmission and distribution system operators

  19. West Valley Demonstration Project Annual Site Environmental Report Calendar Year 2008

    Energy Technology Data Exchange (ETDEWEB)

    West Valley Environmental Services LLC (WVES) and URS - Washington Division

    2009-09-24

    Annual Site Environmental Report for the West Valley Demonstration Project (WVDP) for Calendar Year 2008. The report summarizes the calendar year (CY) 2008 environmental monitoring program data at the WVDP so as to describe the performance of the WVDP’s environmental management system (EMS), confirm compliance with standards and regulations, and highlight important programs. Monitoring and surveillance of the facilities used by the DOE are conducted to verify protection of the environment, continual improvement, prevention and/or minimization of pollution, public outreach, and stakeholder involvement. In addition to demonstrating compliance with environmental regulations and directives, evaluation of data collected in 2008 continued to indicate that WVDP activities pose no threat to public health or safety, or to the environment.

  20. West Valley Demonstration Project Annual Site Environmental Report Calendar Year 2008

    International Nuclear Information System (INIS)

    2009-01-01

    Annual Site Environmental Report for the West Valley Demonstration Project (WVDP) for Calendar Year 2008. The report summarizes the calendar year (CY) 2008 environmental monitoring program data at the WVDP so as to describe the performance of the WVDP's environmental management system (EMS), confirm compliance with standards and regulations, and highlight important programs. Monitoring and surveillance of the facilities used by the DOE are conducted to verify protection of the environment, continual improvement, prevention and/or minimization of pollution, public outreach, and stakeholder involvement. In addition to demonstrating compliance with environmental regulations and directives, evaluation of data collected in 2008 continued to indicate that WVDP activities pose no threat to public health or safety, or to the environment.

  1. Integrating process safety with molecular modeling-based risk assessment of chemicals within the REACH regulatory framework: benefits and future challenges.

    Science.gov (United States)

    Lewis, Amanda; Kazantzis, Nikolaos; Fishtik, Ilie; Wilcox, Jennifer

    2007-04-11

    Registration, evaluation and authorization of chemicals (REACH) represents a recent regulatory initiative by the European union commission to protect human health and the environment from potentially hazardous chemicals. Under REACH, all stakeholders must submit (thermo)physical, thermochemical, and toxicological data for certain chemicals. The commission's impact assessment studies estimate that the costs of REACH will be approximately 3-5 billion Euros. The present study advocates the systematic incorporation of computational chemistry and computer-assisted chemical risk assessment methods into REACH to reduce regulatory compliance costs. Currently powerful computer-aided ab initio techniques can be used to generate predictions of key properties of broad classes of chemicals, without resorting to costly experimentation and potentially hazardous testing. These data could be integrated into a centralized IT decision and compliance support system, and stored in a retrievable, easily communicable manner should new regulatory and/or production requirements necessitate the introduction of different uses of chemicals under different conditions. For illustration purposes, ab initio calculations are performed on heterocyclic nitrogen-containing compounds which currently serve as high energy density materials in the chemical industry. Since investigations of these compounds are still in their infancy, stability studies are imperative regarding their safe handling and storage, as well as registration under REACH.

  2. Integrating process safety with molecular modeling-based risk assessment of chemicals within the REACH regulatory framework: Benefits and future challenges

    International Nuclear Information System (INIS)

    Lewis, Amanda; Kazantzis, Nikolaos; Fishtik, Ilie; Wilcox, Jennifer

    2007-01-01

    Registration, evaluation and authorization of chemicals (REACH) represents a recent regulatory initiative by the European union commission to protect human health and the environment from potentially hazardous chemicals. Under REACH, all stakeholders must submit (thermo)physical, thermochemical, and toxicological data for certain chemicals. The commission's impact assessment studies estimate that the costs of REACH will be approximately 3-5 billion Euros. The present study advocates the systematic incorporation of computational chemistry and computer-assisted chemical risk assessment methods into REACH to reduce regulatory compliance costs. Currently powerful computer-aided ab initio techniques can be used to generate predictions of key properties of broad classes of chemicals, without resorting to costly experimentation and potentially hazardous testing. These data could be integrated into a centralized IT decision and compliance support system, and stored in a retrievable, easily communicable manner should new regulatory and/or production requirements necessitate the introduction of different uses of chemicals under different conditions. For illustration purposes, ab initio calculations are performed on heterocyclic nitrogen-containing compounds which currently serve as high energy density materials in the chemical industry. Since investigations of these compounds are still in their infancy, stability studies are imperative regarding their safe handling and storage, as well as registration under REACH

  3. 12 CFR 1710.19 - Compliance and risk management programs; compliance with other laws.

    Science.gov (United States)

    2010-01-01

    ... OVERSIGHT, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT SAFETY AND SOUNDNESS CORPORATE GOVERNANCE Corporate Practices and Procedures § 1710.19 Compliance and risk management programs; compliance with other laws. (a...

  4. Georgia Compliance Review Self-Study FY 01.

    Science.gov (United States)

    Georgia State Dept. of Education, Atlanta.

    Intended for evaluation of local compliance with special education federal and state legal requirements, this compliance review document includes both the compliance requirements and the criteria by which compliance is determined during the onsite compliance review of Georgia local school systems and state-operated programs. Each legal requirement…

  5. Compliance with removable orthodontic appliances.

    Science.gov (United States)

    Shah, Nirmal

    2017-12-22

    Data sourcesMedline via OVID, PubMed, Cochrane Central Register of Controlled Trials, Web of Science Core Collection, LILACS and BBO databases. Unpublished clinical trials accessed using ClinicalTrials.gov, National Research Register, ProQuest Dissertation and Thesis database.Study selectionTwo authors searched studies from inception until May 2016 without language restrictions. Quantitative and qualitative studies incorporating objective data on compliance with removable appliances, barriers to appliance wear compliance, and interventions to improve compliance were included.Data extraction and synthesisQuality of research was assessed using the Cochrane Collaboration's risk of bias tool, the risk of bias in non-randomised studies of interventions (ROBINS-I), and the mixed methods appraisal tool. Statistical heterogeneity was investigated by examining a graphic display of the estimated compliance levels in conjunction with 95% confidence intervals and quantified using the I-squared statistic. A weighted estimate of objective compliance levels for different appliances in relation to stipulated wear and self-reported levels was also calculated. Risk of publication bias was assessed using funnel plots. Meta-regression was undertaken to assess the relative effects of appliance type on compliance levels.ResultsTwenty-four studies met the inclusion criteria. Of these, 11 were included in the quantitative synthesis. The mean duration of objectively measured wear was considerably lower than stipulated wear time amongst all appliances. Headgear had the greatest discrepancy (5.81 hours, 95% confidence interval, 4.98, 6.64). Self-reported wear time was consistently higher than objectively measured wear time amongst all appliances. Headgear had the greatest discrepancy (5.02 hours, 95% confidence interval, 3.64, 6.40). Two studies found an increase in compliance with headgear and Hawley retainers when patients were aware of monitoring. Five studies found younger age groups to

  6. Examination of utility Phase 1 compliance choices and state reactions to Title IV of the Clean Air Act Amendments of 1990

    International Nuclear Information System (INIS)

    Bailey, K.A.; Elliott, T.J.; Carlson, L.J.; South, D.W.

    1993-11-01

    Title IV (acid rain) of the Clean Air Act Amendments of 1990 is imposing new limitations on the emission of sulfur dioxide (SO 2 ) and nitrogen oxides (N x ) from electric power plants. The act requires utilities to develop compliance plans to reduce these emissions, and indications are that these plans will dramatically alter traditional operating procedures. A key provision of the SO 2 control program deaned in Title IV is the creation of a system of emission allowances, with utilities having the option of complying by adjusting system emissions and allowance holdings. A compilation of SO 2 compliance activities by the 110 utility plants affected by Phase I is summarized in this report. These compliance plans are presented in a tabular form, correlated with age, capacity, and power pool data. A large number of the Phase I units (46%) have chosen to blend or switch to lower sulfur coals. This choice primarily is in response to (1) prices of low-sulfur coal and (2) the need to maintain SO 2 control flexibility because of uncertain future environmental regulations (e.g., air toxics, carbon dioxide) and compliance prices. The report also discusses the responses of state legislatures and public utility commissions to the compliance requirements in Title IV. Most states have taken negligible action regarding the regulatory treatment of allowances and compliance activities. To protect mine employment, states producing high-sulfur coal have enacted regulations encouraging continued use of that coal, but for the most part, this response has had little effect on utility compliance choices

  7. 14 CFR 26.49 - Compliance plan.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Compliance plan. 26.49 Section 26.49... Data for Repairs and Alterations § 26.49 Compliance plan. (a) Compliance plan. Except for applicants... January 11, 2008, each person identified in §§ 26.43, 26.45, and 26.47, must submit a compliance plan...

  8. Directory of certificates of compliance for radioactive materials packages

    International Nuclear Information System (INIS)

    1991-10-01

    This directory contains a Report of NRC Approved Packages (Volume 1), Certificates of Compliance (Volume 2), and Report of NRC Approved Quality Assurance Programs for Radioactive Materials Packages (Volume 3). The purpose of this directory is to make available a convenient source of information on Quality Assurance Programs and Packagings which have been approved by the US Nuclear Regulatory Commission. Shipments of radioactive material utilizing these packagings must be in accordance with the provisions of 49 CFR section 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 themselves that they have a copy of the current approval and conduct their transportation activities in accordance with an NRC approved quality assurance program

  9. 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.

  10. Motivation for Compliance with Environmental Regulation

    DEFF Research Database (Denmark)

    Winter, Søren; May, Peter J.

    2001-01-01

    A combination of calculated, normative, and social motivations as well as awareness of rules and capacity to comply are thought to foster compliance with regulations. Hypotheses about these factors were tested with data concerning Danish farmers’ compliance with agro-environmental regulations....... Three key findings emerge: that farmers’ awareness of rules plays a critical role; that normative and social motivations are as influential as calculated motivations in enhancing compliance; and that inspectors’ enforcement style affects compliance differently from that posited in much of the literature...... compliance with social and environmental regulations....

  11. Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Canada

    International Nuclear Information System (INIS)

    2009-01-01

    This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction (Licensing system; Offences, compliance and enforcement; Regulatory documents; Other relevant legislation); 2. Mining regime; 3. Nuclear substances and radiation devices; 4. Nuclear facilities; 5. Trade in nuclear materials and equipment (Exports, Other imports); 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Governor in council; Minister of natural resources; Other Ministerial authorities; Canadian Nuclear Safety Commission - CNSC); 2. Public and semi-public agencies (National Research Council - NRC; Natural Sciences and Engineering Research Council; Atomic Energy of Canada Ltd. - AECL)

  12. Regulatory aspects of radiation protection in Indian nuclear plants

    International Nuclear Information System (INIS)

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

    2012-01-01

    design changes/system modifications for dose reduction; provisions for collective budgeted dose; institutionalization of ALARA programme; reporting of radiological conditions in periodic health physics and environmental survey reports; ensuring compliance on regulatory inspection recommendations; revision of effluents discharge limits and improvement in nuclear emergency management systems. The paper also presents an overview of the trends in occupational and public doses vis-à-vis regulatory oversight in nuclear power plants of our country. (author)

  13. 40 CFR 63.9622 - What test methods and other procedures must I use to establish and demonstrate initial compliance...

    Science.gov (United States)

    2010-07-01

    ... flow rate corresponding to any of the three test runs. (3) If a rod-deck venturi scrubber is applied to... compliance with the operating limits? (a) For wet scrubbers subject to performance testing in § 63.9620 and operating limits for pressure drop and scrubber water flow rate in § 63.9590(b)(1), you must establish site...

  14. WIPP Waste Characterization: Implementing Regulatory Requirements in the Real World

    International Nuclear Information System (INIS)

    Cooper Wayman, J.D.; Goldstein, J.D.

    1999-01-01

    It is imperative to ensure compliance of the Waste Isolation Pilot Project (WIPP) with applicable statutory and regulatory requirements. In particular, compliance with the waste characterization requirements of the Resource Conservation and Recovery Act (RCRA) and its implementing regulation found at 40 CFR Parts 262,264 and 265 for hazardous and mixed wastes, as well as those of the Atomic Energy Act of 1954, as amended, the Reorganization Plan No. 3 of 1970, the Nuclear Waste Policy Act of 1982, as amended, and the WIPP Land Withdrawal Act, as amended, and their implementing regulations found at 40 CFR Parts 191 and 194 for non-mixed radioactive wastes, are often difficult to ensure at the operational level. For example, where a regulation may limit a waste to a certain concentration, this concentration may be difficult to measure. For example, does the definition of transuranic waste (TRU) as 100 nCi/grain of alpha-emitting transuranic isotopes per gram of waste mean that the radioassay of a waste must show a reading of 100 plus the sampling and measurement error for the waste to be a TRU waste? Although the use of acceptable knowledge to characterize waste is authorized by statute, regulation and DOE Orders, its implementation is similarly beset with difficulty. When is a document or documents sufficient to constitute acceptable knowledge? What standard can be used to determine if knowledge is acceptable for waste characterization purposes? The inherent conflict between waste characterization regulatory requirements and their implementation in the real world, and the resolution of this conflict, will be discussed

  15. Electric vehicle demonstration

    Energy Technology Data Exchange (ETDEWEB)

    Ouellet, M. [National Centre for Advanced Transportation, Saint-Jerome, PQ (Canada)

    2010-07-01

    The desirable characteristics of Canadian projects that demonstrate vehicle use in real-world operation and the appropriate mechanism to collect and disseminate the monitoring data were discussed in this presentation. The scope of the project was on passenger cars and light duty trucks operating in plug-in electric vehicle (PHEV) or battery electric vehicle modes. The presentation also discussed the funding, stakeholders involved, Canadian travel pattern analysis, regulatory framework, current and recent electric vehicle demonstration projects, and project guidelines. It was concluded that some demonstration project activities may have been duplicated as communication between the proponents was insufficient. It was recommended that data monitoring using automatic data logging with minimum reliance on logbooks and other user entry should be emphasized. figs.

  16. Evaluating brief motivational and self-regulatory hand hygiene interventions: a cross-over longitudinal design.

    Science.gov (United States)

    Lhakhang, Pempa; Lippke, Sonia; Knoll, Nina; Schwarzer, Ralf

    2015-02-04

    Frequent handwashing can prevent infections, but non-compliance to hand hygiene is pervasive. Few theory- and evidence-based interventions to improve regular handwashing are available. Therefore, two intervention modules, a motivational and a self-regulatory one, were designed and evaluated. In a longitudinal study, 205 young adults, aged 18 to 26 years, were randomized into two intervention groups. The Mot-SelfR group received first a motivational intervention (Mot; risk perception and outcome expectancies) followed by a self-regulatory intervention (SelfR; perceived self-efficacy and planning) 17 days later. The SelfR-Mot group received the same two intervention modules in the opposite order. Follow-up data were assessed 17 and 34 days after the baseline. Both intervention sequences led to an increase in handwashing frequency, intention, self-efficacy, and planning. Also, overall gains were found for the self-regulatory module (increased planning and self-efficacy levels) and the motivational module (intention). Within groups, the self-regulatory module appeared to be more effective than the motivational module, independent of sequence. Self-regulatory interventions can help individuals to exhibit more handwashing. Sequencing may be important as a motivation module (Mot) first helps to set the goal and a self-regulatory module (SelfR) then helps to translate this goal into actual behavior, but further research is needed to evaluate mechanisms.

  17. Regulatory control of nuclear safety in Finland. Annual report 1997

    International Nuclear Information System (INIS)

    Tossavainen, K.

    1998-08-01

    The report describes regulatory control of the use of nuclear energy by the Radiation and Nuclear Safety Authority (STUK) in Finland in 1997. Nuclear regulatory control ascertained that the operation of Finnish NPPs was in compliance with the conditions set out in operating licences and current regulations. In addition to NPP normal operation, STUK oversaw projects at the plant units relating to power uprating and safety improvements. STUK prepared statements for the Ministry of Trade and Industry about the applications for renewing the operating licenses of Loviisa and Olkiluoto NPPs. The most important items of supervision in nuclear waste management were studies relating to the final disposal of spent fuel from NPPs and the review of the licence application for a repository for low- and intermediate-level reactor waste from Loviisa NPP. Preparation of general safety regulations for the final disposal of spent nuclear fuel, to be published in the form of a Council of State Decision, was started. By safeguards control, the use of nuclear materials was verified to be in compliance with current regulations and that the whereabouts of every batch of nuclear material were always known. Nuclear material safeguards were stepped up to prevent illicit trafficking of nuclear materials and other radioactive materials. In co-operation with the Ministry for Foreign Affairs and the Institute of Seismology (University of Helsinki), preparations were undertaken to implement the Comprehensive Nuclear Test Ban Treaty (CTBT). For enforcement of the Treaty and as part of the international regulatory approach, STUK is currently developing laboratory analyses relating to airborne radioactivity measurements. The focus of co-operation funded by external sources was as follows: improvement of the safety of Kola and Leningrad NPPs, improvement of nuclear waste management in North-West Russia, development of the organizations of nuclear safety authorities in Eastern Europe and development

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

    International Nuclear Information System (INIS)

    1979-10-01

    This directory contains a Summary Report of NRC Approved Packages 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. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory

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

    Energy Technology Data Exchange (ETDEWEB)

    None

    1979-10-01

    This directory contains a Summary Report of NRC Approved Packages 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. The Summary Report includes a listing of all users of each package design prior to the publication date of the directory.

  20. Assessing the management system to demonstrate the safe of transport of radioactive material

    Energy Technology Data Exchange (ETDEWEB)

    Bruno, Natanael C.; Mattar, Patricia M.; Pontes, Andre T., E-mail: nbruno@cnen.gov.br, E-mail: pmattar@cnen.gov.br, E-mail: atpontes@id.uff.br [Comissao Nacional de Energia Nuclear (CNEN), Rio de Janeiro, RJ (Brazil); Universidade Federal Fluminense (UFF), Niteroi, RJ (Brazil)

    2017-11-01

    Radioactive materials are used for medical purposes, to avoid greenhouse gas effect in energy production plants, food and other products sterilization, research and sophisticated measurement technologies. Transport of radioactive material involves a range of actors each one having specific responsibilities for safety. Through Management System, consignors and carriers fulfil objective evidences that safety requirements are met in practice, while compliance assurance programs allow regulatory bodies and/or competent authorities to demonstrate to society that public, workers and environment are protected. According to the International Atomic Energy Agency (IAEA), safety has to be achieved and maintained through an effective management system. This system should integrate all elements of management so that requirements for safety are established and applied consistently with other requirements, including those related to human performance, quality and security, and that safety is not compromised by other requirements or demands. Comissao Nacional de Energia Nuclear (CNEN), the Brazilian Regulatory Body for the safe transport of radioactive materials, adopt international standards to establish safety requirements deemed relevant for protection of health and minimization of danger to life and property, and to provide for the application of these standards. Seeking for continuous improvement, the adherence of the practices adopted by CNEN's Transport Safety Unit (TSU) against the recommendations from the IAEA was assessed. This assessment led to the elaboration of proposals for improvement as well as the identification of good practices. The methodology used to perform this assessment was the SARIS methodology, developed by the IAEA. This paper will describe the most relevant findings of this study. (author)

  1. Assessing the management system to demonstrate the safe of transport of radioactive material

    International Nuclear Information System (INIS)

    Bruno, Natanael C.; Mattar, Patricia M.; Pontes, Andre T.

    2017-01-01

    Radioactive materials are used for medical purposes, to avoid greenhouse gas effect in energy production plants, food and other products sterilization, research and sophisticated measurement technologies. Transport of radioactive material involves a range of actors each one having specific responsibilities for safety. Through Management System, consignors and carriers fulfil objective evidences that safety requirements are met in practice, while compliance assurance programs allow regulatory bodies and/or competent authorities to demonstrate to society that public, workers and environment are protected. According to the International Atomic Energy Agency (IAEA), safety has to be achieved and maintained through an effective management system. This system should integrate all elements of management so that requirements for safety are established and applied consistently with other requirements, including those related to human performance, quality and security, and that safety is not compromised by other requirements or demands. Comissao Nacional de Energia Nuclear (CNEN), the Brazilian Regulatory Body for the safe transport of radioactive materials, adopt international standards to establish safety requirements deemed relevant for protection of health and minimization of danger to life and property, and to provide for the application of these standards. Seeking for continuous improvement, the adherence of the practices adopted by CNEN's Transport Safety Unit (TSU) against the recommendations from the IAEA was assessed. This assessment led to the elaboration of proposals for improvement as well as the identification of good practices. The methodology used to perform this assessment was the SARIS methodology, developed by the IAEA. This paper will describe the most relevant findings of this study. (author)

  2. 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

  3. Compliance strategy for statistically based neutron overpower protection safety analysis methodology

    International Nuclear Information System (INIS)

    Holliday, E.; Phan, B.; Nainer, O.

    2009-01-01

    The methodology employed in the safety analysis of the slow Loss of Regulation (LOR) event in the OPG and Bruce Power CANDU reactors, referred to as Neutron Overpower Protection (NOP) analysis, is a statistically based methodology. Further enhancement to this methodology includes the use of Extreme Value Statistics (EVS) for the explicit treatment of aleatory and epistemic uncertainties, and probabilistic weighting of the initial core states. A key aspect of this enhanced NOP methodology is to demonstrate adherence, or compliance, with the analysis basis. This paper outlines a compliance strategy capable of accounting for the statistical nature of the enhanced NOP methodology. (author)

  4. The interactive effects of belongingness and charisma on helping and compliance

    NARCIS (Netherlands)

    den Hartog, D.N.; de Hoogh, A.H.B.; Keegan, A.E.

    2007-01-01

    This study tests the main and interactive effects of belongingness and perceived charismatic leadership on 2 forms of organizational citizenship behavior (helping and compliance). In line with expectations, a study of 115 manager-subordinate dyads demonstrates that employees show more helping

  5. Oil spill prevention: Regulatory trends and compliance at existing storage terminals and refineries

    International Nuclear Information System (INIS)

    Janisz, A.J.

    1993-01-01

    In 1973, the Spill Prevention, Control, and Countermeasure (SPCC) regulations were promulgated. The objective of the regulations was to prevent oil spills. However, in the late 1980s and early 1990s, several catastrophic spills of oils led to review of oil spill prevention regulations by the U.S. Environmental Protection Agency, the US Coast Guard, and the Department of the Interior's Minerals Management Service. The reviews led to promulgation of various acts and regulations including the proposed revisions to the SPCC regulations, the Oil Pollution Act of 1990 (OPA-90), and others. Numerous facilities within the petroleum and chemical industry were or will be affected by these regulations. This paper discusses regulatory trends for spill planning and prevention in general, but principally concentrates on above ground storage tanks at facilities storing or refining petroleum products. The paper includes discussions of bills on above ground storage tanks and proposed national standards, as well as regulatory trends in various states. Proposed SPCC regulations and their effects on the industry are also discussed, including requirements for impermeable surfaces and increasing secondary containment capacity. Management strategies to review facility operations and prepare for upgrades are outlined. The paper discusses the types of upgrades typically necessary at existing storage terminals and refineries and discusses information necessary to prepare conceptual designs and cost estimates. Cost estimates for typical upgrades, such as raising earthen berms and installing isolation valves, are presented. Facilities in the state of New Jersey are used as examples, because regulations in New Jersey are similar to the proposed federal regulations

  6. Identification of factors involved in medication compliance: incorrect inhaler technique of asthma treatment leads to poor compliance

    Directory of Open Access Journals (Sweden)

    Darbà J

    2016-02-01

    Full Text Available Josep Darbà,1 Gabriela Ramírez,2 Antoni Sicras,3 Laura García-Bujalance,4 Saku Torvinen,5 Rainel Sánchez-de la Rosa6 1Department of Economics, Universitat de Barcelona, 2BCN Health Economics & Outcomes Research S.L., 3Department of Planning, Badalona Serveis Assistencials S.A., Barcelona, 4Market Access Department, Teva Pharmaceutical, Madrid, Spain; 5Market Access Department, Teva Pharmaceuticals Europe BV, Amsterdam, the Netherlands; 6Medical Department, Teva Pharmaceutical, Madrid, Spain Objective: To identify the impact of delivery device of inhaled corticosteroids and long-acting β2-agonist (ICS/LABA on asthma medication compliance, and investigate other factors associated with compliance. Materials and methods: We conducted a retrospective and multicenter study based on a review of medical registries of asthmatic patients treated with ICS/LABA combinations (n=2,213 whose medical devices were either dry powder inhalers (DPIs, such as Accuhaler®, Turbuhaler®, and NEXThaler® or pressurized metered-dose inhalers (pMDI. Medication compliance included persistence outcomes through 18 months and medication possession ratios. Data on potential confounders of treatment compliance such as asthma exacerbations, comorbidities, demographic characteristics, and health care resource utilization were also explored. Results: The probability of asthma medication compliance in case of DPIs was lower compared to pMDIs, which suggests that inhaler devices influence inhalation therapies. There were additional confounding factors that were considered as explanatory variables of compliance. A worse measure of airflow obstruction (forced expiration volume in 1 second, comorbidities and general practitioner (GP consultations more than once per month decreased the probability of compliance. Within comorbidities, alcoholism was positively associated with compliance. Patients of 29–39, 40–50, and 51–61 age groups or suffering from more than two

  7. Compliance and Enforcement Actions (CEA) -

    Data.gov (United States)

    Department of Transportation — Compliance and Enforcement Actions application provides process assistance / improvements for conducting investigation and enforcement activities. The Compliance and...

  8. Strategisk compliance og regulering

    DEFF Research Database (Denmark)

    Kühn Pedersen, Mogens

    2016-01-01

    Denne artikel introducerer strategisk compliance og påpeger dens samspil med klassiske og nyere former for reguleringer i digital værdiskabelse. Konteksten er den digitale økonomi, som vokser frem imellem den materielle økonomis bærepiller: Virksomheder og markeder, men består af en helt ny...... materialitet, som er det digitale univers og dets modsvarighed i nye krav til compliance. Den nye materialitet stiller nye krav, hvad angår digitale processer og transaktioner. Klassisk regulering, som aktører ikke selv kan ændre, støder på egenregulering, hvor aktørerne selv opsætter regler for at skabe...... digital værdi. Dette kalder på strategisk compliance. Med digitalisering er strategisk compliance sat på dagsordnen i reguleringsdebatten. Vi hævder, at regulering og egenregulering kan komme til at virke komplementært i det post-industrielle, digitaliserede samfund....

  9. A systematic review on hand hygiene knowledge and compliance in student nurses.

    Science.gov (United States)

    Labrague, L J; McEnroe-Petitte, D M; van de Mortel, T; Nasirudeen, A M A

    2017-10-27

    Hand hygiene competence is one of the critical outcomes in nursing education. Ensuring nursing students recognize the what, when and how of hand hygiene is critical in the light of the increasing rates of healthcare-associated infections. To systematically appraise and synthesize articles on hand hygiene knowledge and compliance among nursing students. This is a systematic review of scientific articles published from 2006 to 2016. The primary databases used were as follows: PubMed, Embase, Cumulative Index to Nursing & Allied Health Literature, Proquest and PsychINFO. Key search terms utilized were as follows: 'handwashing', 'hand hygiene', 'compliance', 'knowledge', 'practice' and 'nursing students'. Nineteen studies met the review criteria. The findings revealed a low-to-moderate knowledge of and compliance with hand hygiene among nursing students. In addition, there were significantly higher rates of hand hygiene compliance in nursing students when compared to medical students. Relatively few studies attempted to identify predictors of hand hygiene knowledge and compliance. This review demonstrated suboptimal knowledge and compliance to hand hygiene among student nurses. In addition, this review also highlighted the paucity of studies that examined individual and organizational factors, which influence nursing students hand hygiene knowledge and compliance. The findings of this review emphasized the role of nurse educators in enhancing hand hygiene competence in nursing students. Implementation of empirically tested strategies such as utilizing multidimensional interventions, scenario-based hand hygiene simulation activities and hand hygiene education programmes that would enhance nursing students' hand hygiene knowledge and compliance is an asset. Hospital and nursing administrators should ensure continuous support and monitoring to guarantee that hand hygiene programmes are institutionalized in every healthcare setting by every healthcare worker. © 2017

  10. Barriers to compliance with evidence-based care in trauma.

    Science.gov (United States)

    Rayan, Nadine; Barnes, Sunni; Fleming, Neil; Kudyakov, Rustam; Ballard, David; Gentilello, Larry M; Shafi, Shahid

    2012-03-01

    We have preciously demonstrated that trauma patients receive less than two-thirds of the care recommended by evidence-based medicine. The purpose of this study was to identify patients least likely to receive optimal care. Records of a random sample of 774 patients admitted to a Level I trauma center (2006-2008) with moderate to severe injuries (Abbreviated Injury Scale score ≥3) were reviewed for compliance with 25 trauma-specific processes of care (T-POC) endorsed by Advanced Trauma Life Support, Eastern Association for the Surgery of Trauma, the Brain Trauma Foundation, Surgical Care Improvement Project, and the Glue Grant Consortium based on evidence or consensus. These encompassed all aspects of trauma care, including initial evaluation, resuscitation, operative care, critical care, rehabilitation, and injury prevention. Multivariate logistic regression was used to identify patients likely to receive recommended care. Study patients were eligible for a total of 2,603 T-POC, of which only 1,515 (58%) were provided to the patient. Compliance was highest for T-POC involving resuscitation (83%) and was lowest for neurosurgical interventions (17%). Increasing severity of head injuries was associated with lower compliance, while intensive care unit stay was associated with higher compliance. There was no relationship between compliance and patient demographics, socioeconomic status, overall injury severity, or daily volume of trauma admissions. Little over half of recommended care was delivered to trauma patients with moderate to severe injuries. Patients with increasing severity of traumatic brain injuries were least likely to receive optimal care. However, differences among patient subgroups are small in relation to the overall gap between observed and recommended care. II.

  11. Compliance of disease awareness campaigns in printed Dutch media with national and international regulatory guidelines.

    Science.gov (United States)

    Leonardo Alves, Teresa; Martins de Freitas, Auramarina F; van Eijk, Martine E C; Mantel-Teeuwisse, Aukje K

    2014-01-01

    The European legislation prohibits prescription-only medicines' advertising but allows pharmaceutical companies to provide information to the public on health and diseases, provided there is no direct or indirect reference to a pharmaceutical product. Various forms of promotion have become increasingly common in Europe including "disease-oriented" campaigns. To explore examples of disease awareness campaigns by pharmaceutical companies in the Netherlands, by assessing their compliance with the World Health Organization (WHO) Ethical Criteria for medicinal drug promotion and the Dutch guidelines for provision of information by pharmaceutical companies. Materials referring to health/disease and treatments published in the most widely circulated newspapers and magazines were collected from March to May 2012. An evaluation tool was developed based on relevant underlying principles from the WHO ethical criteria and Dutch self-regulation guidelines. Collected disease awareness advertisements were used to pilot the evaluation tool and to explore the consistency of information provided with the WHO and Dutch criteria. Eighty materials met our inclusion criteria; 71 were published in newspapers and 9 in magazines. The large majority were news items but 21 were disease awareness advertisements, of which 5 were duplicates. Fifteen out of the 16 disease awareness campaigns were non-compliant with current guidelines mainly due to lack of balance (n = 12), absence of listed author and/or sponsor (n = 8), use of misleading or incomplete information (n = 5) and use of promotional information (n = 5). None mentioned a pharmaceutical product directly. Disease Awareness Campaigns are present in Dutch printed media. Although no brand names were mentioned, the lack of compliance of disease awareness campaigns with the current regulations is alarming. There were information deficiencies and evidence of information bias. A key concern is that the context in which the information is

  12. Recurrent rewiring and emergence of RNA regulatory networks.

    Science.gov (United States)

    Wilinski, Daniel; Buter, Natascha; Klocko, Andrew D; Lapointe, Christopher P; Selker, Eric U; Gasch, Audrey P; Wickens, Marvin

    2017-04-04

    Alterations in regulatory networks contribute to evolutionary change. Transcriptional networks are reconfigured by changes in the binding specificity of transcription factors and their cognate sites. The evolution of RNA-protein regulatory networks is far less understood. The PUF (Pumilio and FBF) family of RNA regulatory proteins controls the translation, stability, and movements of hundreds of mRNAs in a single species. We probe the evolution of PUF-RNA networks by direct identification of the mRNAs bound to PUF proteins in budding and filamentous fungi and by computational analyses of orthologous RNAs from 62 fungal species. Our findings reveal that PUF proteins gain and lose mRNAs with related and emergent biological functions during evolution. We demonstrate at least two independent rewiring events for PUF3 orthologs, independent but convergent evolution of PUF4/5 binding specificity and the rewiring of the PUF4/5 regulons in different fungal lineages. These findings demonstrate plasticity in RNA regulatory networks and suggest ways in which their rewiring occurs.

  13. How good is compliance with smoke-free legislation in India? Results of 38 subnational surveys.

    Science.gov (United States)

    Kumar, Ravinder; Goel, Sonu; Harries, Anthony D; Lal, Pranay; Singh, Rana J; Kumar, Ajay M V; Wilson, Nevin C

    2014-09-01

    India has been implementing smoke-free legislation since 2008 prohibiting smoking in public places. This study aimed to assess the level of compliance with smoke-free legislation (defined as the presence of no-smoking signage and the absence of active smoking, smoking aids, cigarette butts/bidi ends and smoking smell) and the role of enforcement systems in Indian jurisdictions. This was a cross-sectional, retrospective review of reports and primary data sheets of surveys conducted in 38 selected jurisdictions across India in 2012-2013. Of 20 455 public places (in 38 jurisdictions), 10 377 (51%) demonstrated full compliance with smoke-free law. Educational institutions and healthcare facilities performed well at 65% and 62%, respectively, while eateries and frequently visited other public places (such as bus stands, railway stations, shopping malls, stadia, cinema halls etc.) performed poorly at 37% and 27%, respectively. Absence of no-smoking signage was the largest contributor to non-compliance across all types of public places. Enforcement systems were present in all jurisdictions, but no associations could be demonstrated between these and smoke-free compliance. Smoke-free compliance in public places in India was suboptimal and was mainly related to the absence of no-smoking signage. This warrants further pragmatic and innovative ways to improve the situation. © The Author 2014. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  14. Directory of certificates of compliance for radioactive materials packages. Volume 3, revision 1. Summary report of NRC approved quality assurance programs for radioactive material packages

    International Nuclear Information System (INIS)

    1981-12-01

    The 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 U.S. Nuclear Regulatory Commission. To assist in identifying packaging, and 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

  15. Motivation and compliance with intraoral elastics.

    Science.gov (United States)

    Veeroo, Helen J; Cunningham, Susan J; Newton, Jonathon Timothy; Travess, Helen C

    2014-07-01

    Intraoral elastics are commonly used in orthodontics and require regular changing to be effective. Unfortunately, poor compliance with elastics is often encountered, especially in adolescents. Intention for an action and its implementation can be improved using "if-then" plans that spell out when, where, and how a set goal, such as elastic wear, can be put into action. Our aim was to determine the effect of if-then plans on compliance with elastics. To identify common barriers to compliance with recommendations concerning elastic wear, semistructured interviews were carried out with 14 adolescent orthodontic patients wearing intraoral elastics full time. Emerging themes were used to develop if-then plans to improve compliance with elastic wear. A prospective pilot study assessed the effectiveness of if-then planning aimed at overcoming the identified barriers on compliance with elastic wear. Twelve participants were randomized equally into study and control groups; the study group received information about if-then planning. The participants were asked to collect used elastics, and counts of these were used to assess compliance. A wide range of motivational and volitional factors were described by the interviewed participants, including the perceived benefits of elastics, cues to remember, pain, eating, social situations, sports, loss of elastics, and breakages. Compliance with elastic wear was highly variable among patients. The study group returned more used elastics, suggesting increased compliance, but the difference was not significant. The use of if-then plans might improve compliance with elastic wear when compared with routine clinical instructions. Copyright © 2014 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

  16. Development of an assessment scale for treatment compliance in type 2 Diabetes Mellitus in Turkish population: Psychometric evaluation

    Directory of Open Access Journals (Sweden)

    Ayla Demirtaş

    2017-07-01

    Conclusion: The results of the study demonstrated that the scale with 30 items is a valid and reliable scale for the evaluation of patient compliance with type 2 DM treatment. Thus, by using this scale, nurses and healthcare providers can evaluate the treatment compliance of patients with type 2 DM.

  17. 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.

  18. An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

    International Nuclear Information System (INIS)

    Jeffries, Sherryl A.; Robinson, John W.; Craighead, Peter S.; Keats, Melanie R.

    2006-01-01

    Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators

  19. Therapeutic compliance of first line disease-modifying therapies in patients with multiple sclerosis. COMPLIANCE Study.

    Science.gov (United States)

    Saiz, A; Mora, S; Blanco, J

    2015-05-01

    Non-adherence to disease-modifying therapies (DMTs) in multiple sclerosis may be associated with reduced efficacy. We assessed compliance, the reasons for non-compliance, treatment satisfaction, and quality of life (QoL) of patients treated with first-line therapies. A cross-sectional, multicenter study was conducted that included relapsing multiple sclerosis patients. Compliance in the past month was assessed using Morisky-Green test. Seasonal compliance and reasons for non-compliance were assessed by an ad-hoc questionnaire. Treatment satisfaction and QoL were evaluated by means of TSQM and PRIMUS questionnaires. A total of 220 patients were evaluated (91% relapsing-remitting); the mean age was 39.1 years, 70% were female, and the average time under treatment was 5.4 years. Subcutaneous interferon (IFN) β-1b was used in 23% of the patients, intramuscular IFN β-1a in 21%, subcutaneous IFN β-1a in 37%, and with glatiramer acetate in 19%. The overall compliance was 75%, with no significant differences related to the therapy, and 81% did not report any seasonal variation. Compliant patients had significantly lower disability scores and time of diagnosis, and greater satisfaction with treatment and its effectiveness. Discomfort and flu-like symptoms were the most frequent reasons for non-compliance. The satisfaction and QoL were associated with less disability and number of therapeutic switches. The rate of compliance, satisfaction and QoL in multiple sclerosis patients under DMTs is high, especially for those newly diagnosed, less disabled, and with fewer therapeutic switches. Discomfort and flu-like symptoms associated with injected therapies significantly affect adherence. Copyright © 2013 Sociedad Española de Neurología. Published by Elsevier España, S.L.U. All rights reserved.

  20. TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

    International Nuclear Information System (INIS)

    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

  1. TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2016-06-15

    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

  2. Extrinsic incentives and tax compliance

    OpenAIRE

    Sour, Laura; Gutiérrez Andrade, Miguel Ángel

    2011-01-01

    This paper models the impact of extrinsic incentives in a tax compliance model. It also provides experimental evidence that confirms the existence of a positive relationship between rewards and tax compliance. If individuals are audited, rewards for honest taxpayers are effective in increasing the level of tax compliance. These results are particularly relevant in countries where there is little respect for tax law since rewards can contribute to crowding in the intrinsic motivation to comply.

  3. 40 CFR 63.4561 - How do I demonstrate initial compliance?

    Science.gov (United States)

    2010-07-01

    ... demonstration for each general use, TPO, automotive lamp, and assembled on-road vehicle coating operation... in the coating operation controlled by the solvent recovery system during each month. Perform a... recovery system during the month, kg volatile organic matter per kg coating. You may determine the volatile...

  4. 22 CFR 209.6 - Compliance information.

    Science.gov (United States)

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Compliance information. 209.6 Section 209.6... § 209.6 Compliance information. (a) Cooperation and assistance. The Administrator shall to the fullest... and accurate compliance reports at such times, and in such form and containing such information, as...

  5. 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.

  6. Mother Nature versus human nature: public compliance with evacuation and quarantine.

    Science.gov (United States)

    Manuell, Mary-Elise; Cukor, Jeffrey

    2011-04-01

    Effectively controlling the spread of contagious illnesses has become a critical focus of disaster planning. It is likely that quarantine will be a key part of the overall public health strategy utilised during a pandemic, an act of bioterrorism or other emergencies involving contagious agents. While the United States lacks recent experience of large-scale quarantines, it has considerable accumulated experience of large-scale evacuations. Risk perception, life circumstance, work-related issues, and the opinions of influential family, friends and credible public spokespersons all play a role in determining compliance with an evacuation order. Although the comparison is not reported elsewhere to our knowledge, this review of the principal factors affecting compliance with evacuations demonstrates many similarities with those likely to occur during a quarantine. Accurate identification and understanding of barriers to compliance allows for improved planning to protect the public more effectively. © 2011 The Author(s). Disasters © Overseas Development Institute, 2011.

  7. The USAID Environmental Compliance Database

    Data.gov (United States)

    US Agency for International Development — The Environmental Compliance Database is a record of environmental compliance submissions with their outcomes. Documents in the database can be found by visiting the...

  8. Highlights and Comments from a Regulator's Workshop

    International Nuclear Information System (INIS)

    Jensen, Mikael

    2002-01-01

    Mikael Jensen (SSI, Sweden) presented the feedback of the regulatory workshop that took place in Sweden in September 2001, titled 'The Role of Future Society and Biosphere in Demonstrating Compliance with High-level Radioactive Waste Disposal Standards and Regulations'. The theme included questions such as how to meet regulatory compliance with an evolving biosphere and how will regulators judge compliance? During the Workshop, presentations were made from international regulatory aspects such as IAEA or ICRP. There were also very interesting country-by-country presentation such as the Finnish presentation by STUK which specifies limits on radionuclide releases from a repository after a thousand years or so. There appears to be a consensus on the relevance developing initiatives on the sustainable development, the protection of the environment and addressing long time scales. One technical aspects, the geosphere/biosphere interface, was viewed as a key issue for future study and analysis

  9. 24 CFR 107.40 - Compliance meeting.

    Science.gov (United States)

    2010-04-01

    ... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Compliance meeting. 107.40 Section... NONDISCRIMINATION AND EQUAL OPPORTUNITY IN HOUSING UNDER EXECUTIVE ORDER 11063 § 107.40 Compliance meeting. (a... allegedly in violation (respondent) shall be sent a Notice of Compliance Meeting and requested to attend a...

  10. Managing compliance risk after Mifid

    OpenAIRE

    P. Musile Tanzi; G. Gabbi; D. Previati; P. Schwizer

    2013-01-01

    Purpose – The purpose of this paper is to focus on changes in the compliance function within major European banks and other financial intermediaries and on the effects of Markets in Financial Instruments Directive (MiFID) implementation. Design/methodology/approach – The four areas of research seek to answer the following questions: Is the positioning of the compliance function “at the top” of the organizational structure? Are the roles attributed to the compliance function, th...

  11. Overcoming regulatory barriers: DOE environmental technology development program

    International Nuclear Information System (INIS)

    Kurtyka, B.M.; Clodfelter-Schumack, K.; Evans, T.T.

    1995-01-01

    The potential to improve environmental conditions via compliance or restoration is directly related to the ability to produce and apply innovative technological solutions. However, numerous organizations, including the US General Accounting Office (GAO), the EPA National Advisory Council for Environmental Policy and Technology (NACEPT), the DOE Environmental Management Advisory Board (EMAB), and the National Science and Technology Council (NSTC) have determined that significant regulatory barriers exist that inhibit the development and application of these technologies. They have noted the need for improved efforts in identifying and rectifying these barriers for the purpose of improving the technology development process, providing innovative alternatives, and enhancing the likelihood of technology acceptance by all. These barriers include, among others, regulator and user bias against ''unknown/unproven'' technologies; multi-level/multi-media permit disincentives; potential liability of developers and users for failed implementation; wrongly defined or inadequate data quality objectives: and lack of customer understanding and input. The ultimate goal of technology development is the utilization of technologies. This paper will present information on a number of regulatory barriers hindering DOE's environmental technology development program and describe DOE efforts to address these barriers

  12. 24 CFR 108.25 - Compliance meeting.

    Science.gov (United States)

    2010-04-01

    ... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Compliance meeting. 108.25 Section... COMPLIANCE PROCEDURES FOR AFFIRMATIVE FAIR HOUSING MARKETING § 108.25 Compliance meeting. (a) Scheduling meeting. If an applicant fails to comply with requirements under § 108.15 or § 108.20 or it appears that...

  13. Patient compliance with exercise: different theoretical approaches to short-term and long-term compliance.

    NARCIS (Netherlands)

    Sluijs, E.M.; Knibbe, J.J.

    1991-01-01

    Compliance with exercise regimens is difficult to obtain as is compliance with other medical regimens. In analyzing noncompliance, two problems exist: (I) current theories only partly explain patients’ noncompliance; (2) health care providers seldom act according to the recommendations derived from

  14. Above reproach: developing a comprehensive ethics and compliance program.

    Science.gov (United States)

    Yuspeh, A; Whalen, K; Cecelic, J; Clifton, S; Cobb, L; Eddy, M; Fainter, J; Packard, J; Postal, S; Steakley, J; Waddey, P

    1999-01-01

    How can a healthcare organization improve the public's confidence in the conduct of its business operations? What can it do to ensure that it can thrive despite being the subject of public and governmental scrutiny and doubt? Healthcare providers must establish standards of conduct that are above reproach and ensure that those standards are clearly articulated and strictly adhered to. This article describes the merits of a comprehensive ethics and compliance program, suggests five basic elements of such a program--organizational support/structure, setting standards, creating awareness, establishing a mechanism for reporting exceptions, and monitoring and auditing--and then demonstrates how those elements should be applied in several high-risk areas. Fundamentally, an ethics and compliance program has two purposes: to ensure that all individuals in an organization observe pertinent laws and regulations in their work; and to articulate a broader set of aspirational ethical standards that are well-understood within the organization and become a practical guideline for organization members making decisions that raise ethical concerns. Every ethics and compliance program should contain certain fundamental aspects. First, the effort must have the active support of the most senior management in the organization. To instill a commitment to ethics and compliance absent a clear and outspoken commitment to such purposes by organization leaders is simply impossible. Second, an ethics and compliance program is fundamentally about organizational culture--about instilling a commitment to observe the law and, more generally, to do the right thing. Third, ethics and compliance are responsibilities of operating management (sometimes called line management). Although staff such as compliance officers are obligated to provide the necessary resources for a successful program and to design the program, such staff officers cannot achieve implementation and execution. Only operating

  15. SU-F-19A-07: Is a Day30 Scan Necessary to Evaluate Activity-Based Regulatory Compliance in Permanent Interstitial Brachytherapy for Prostate Cancer?

    Energy Technology Data Exchange (ETDEWEB)

    Kapur, P; Ford, J; Moghanaki, D; Datsang, R; Chang, M; Rosu, M [Virginia Commonwealth University, Richmond, Virginia (United States); Veterans Affairs Medical Center, Richmond, VA (United States); Hagan, M; Palta, J [Virginia Commonwealth University, Richmond, Virginia (United States); Veterans Affairs Medical Center, Richmond, VA (United States); National Radiation Oncology Program, Richmond, VA (United States)

    2014-06-15

    Purpose: To evaluate the Medical Event (ME) criteria for I-125 prostate implants based on the assessment of post implant dosimetry on “Day0”/“Day30” imaging. The new ME criteria do not mandate a timeframe for this assessment. The compliance criteria are: more than 80% of the activity from the written directive for treatment site (TS) must be implanted inside TS, and doses to 1cc of either uninvolved rectum (D1-UR) or uninvolved bladder (D1-UB), or 2cc of other non-specified tissue (D2-UT) must be less than 150% of the planned dose. Methods: “Day0”/“Day30” post-implant analyses for 25 patients were evaluated. Treatment plans had a peripheral loading pattern with 2 core needles placed at least 10 mm away from urethra, with several seeds planned outside of the prostate for adequate target coverage. TS were a uniform 5 mm expansion of the prostate, except posteriorly (no expansion). Results: “Day0”/“Day30”analyses found no MEs. The relative changes for D1-UR, D1-UB, and D2-UT were (ranges): [−37.0, 38.2]%, [−96.5, 74.7]%, and [−41.2, 37.7]%. Furthermore, changes did not correlate with prostate volume changes of −18.7% [σ:16.0%, range:−60.5%, +6.4%]. These unfavorable changes did not lead to ME at “Day30” because these values were generally well below 150% at “Day0”. However, D2-UT dose values exceeded those for D1-UR and D1-UB at both “Day0”/“Day30”. Conclusion: The total activity was relatively insensitive to changes in target volume from “Day0” to ”Day30”. The dose metrics of interest, albeit susceptible to large, often unfavorable changes, remained less than the 150% threshold. Data from this study suggest that “Day0” can be used for the regulatory compliance evaluation. However, further evaluation at “Day30” is advisable if D2-UT is 110% or above (based on the largest D2-UT increase of 37.7% observed in this patient population). Future rigorous statistical analysis of a larger cohort will afford a

  16. The Strategic Nature of Compliance

    DEFF Research Database (Denmark)

    König, Thomas; Mäder, Lars Kai

    2014-01-01

    by the anticipated enforcement decision of the monitoring agency and whether this agency is responsive to the probability of enforcement success and the potential sanctioning costs produced by noncomplying implementers. Compared to other monitoring systems, the centralized monitoring system of the European Union (EU......This compliance study models correct and timely implementation of policies in a multilevel system as a strategic game between a central monitoring agency and multiple implementers and evaluates statistically the empirical implications of this model. We test whether compliance is determined......) is praised for exemplary effectiveness, but our findings reveal that the monitoring agency refrains from enforcing compliance when the probability of success is low, and the sanctioning costs are high. This results in a compliance deficit, even though the selective enforcement activities of the monitoring...

  17. Organ procurement organization compliance with 21 CFR 1271: a challenge for allogeneic pancreatic islet cell transplantation programs.

    Science.gov (United States)

    Winters, J L; Tran, S A; Gastineau, D A; Padley, D J; Dean, P G; Kudva, Y C

    2009-06-01

    In order to protect tissue recipients, the Food and Drug Administration drafted Title 21, Section 1271 of the Code of Federal Regulations 1271 (21 CFR 1271) to address infectious disease risk. These regulations apply to tissues but not vascularized organs. Pancreatic islet cells are regulated under 21 CFR 1271. These regulations require qualification of suppliers of critical materials and services with regard to 21 CFR 1271 compliance. As part of supplier qualification, all organ procurement organizations (OPOs) in the United States were sent a questionnaire covering the key components of these regulations. Of the 57 OPOs, 29 (51%) were in compliance based upon survey results. Twelve (21%) were not compliant in one or more areas. All indicated plans to become compliant. The remaining 15 (27%) either failed or refused to complete the survey, some indicating 21 CFR 1271 did not apply to OPOs. Using 2006 data, OPOs compliant with 21 CFR 1271 recovered 50% of the organs procured in the United States. These findings represent a challenge for allogeneic islet cell transplant programs whose raw material must comply with 21 CFR 1271. OPOs should work toward understanding and complying with 21 CFR 1271. Regulatory agencies should work toward enhancing safety of the pancreas supply by facilitating compliance through harmonization of requirements.

  18. Regulatory monitoring systems of fortified salt and wheat flour in selected ASEAN countries.

    Science.gov (United States)

    van den Wijngaart, Annoek; Bégin, France; Codling, Karen; Randall, Philip; Johnson, Quentin W

    2013-06-01

    assurance mechanisms in place to stimulate compliance by food producers, i.e., regulatory monitoring, having national legislation will not necessarily lead to increased coverage of fortified products and associated outcomes.

  19. Stable self-compliance resistive switching in AlOδ/Ta2O5−x/TaOy triple layer devices

    International Nuclear Information System (INIS)

    Wu, Huaqiang; Li, Xinyi; Huang, Feiyang; Yu, Zhiping; Qian, He; Chen, An

    2015-01-01

    Stable self-compliance property was observed in the AlO δ /Ta 2 O 5−x /TaO y triple-layer resistive random access memory structure. The impact of AlO δ barrier layer was studied with different thicknesses. Endurance of more than 10 10 cycles and data retention for more than 3 h at 125 °C were demonstrated. All the measurements were carried out without external current compliance and no hard breakdown was observed. Systematic analysis reveals the self-compliance property is due to the built-in series resistance of the thin AlO δ barrier layer. A model is proposed to explain this self-compliance property. (paper)

  20. 42 CFR 124.503 - Compliance level.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Compliance level. 124.503 Section 124.503 Public... Unable To Pay § 124.503 Compliance level. (a) Annual compliance level. Subject to the provisions of this... persons unable to pay if it provides for the fiscal year uncompensated services at a level not less than...