• 제목/요약/키워드: Regulatory

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SACADA and HuREX part 2: The use of SACADA and HuREX data to estimate human error probabilities

  • Kim, Yochan;Chang, Yung Hsien James;Park, Jinkyun;Criscione, Lawrence
    • Nuclear Engineering and Technology
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    • 제54권3호
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    • pp.896-908
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    • 2022
  • As a part of probabilistic risk (or safety) assessment (PRA or PSA) of nuclear power plants (NPPs), the primary role of human reliability analysis (HRA) is to provide credible estimations of the human error probabilities (HEPs) of safety-critical tasks. In this regard, it is vital to provide credible HEPs based on firm technical underpinnings including (but not limited to): (1) how to collect HRA data from available sources of information, and (2) how to inform HRA practitioners with the collected HRA data. Because of these necessities, the U.S. Nuclear Regulatory Commission and the Korea Atomic Energy Research Institute independently developed two dedicated HRA data collection systems, SACADA (Scenario Authoring, Characterization, And Debriefing Application) and HuREX (Human Reliability data EXtraction), respectively. These systems provide unique frameworks that can be used to secure HRA data from full-scope training simulators of NPPs (i.e., simulator data). In order to investigate the applicability of these two systems, two papers have been prepared with distinct purposes. The first paper, entitled "SACADA and HuREX: Part 1. The Use of SACADA and HuREX Systems to Collect Human Reliability Data", deals with technical issues pertaining to the collection of HRA data. This second paper explains how the two systems are able to inform HRA practitioners. To this end, the process of estimating HEPs is demonstrated based on feed-and-bleed operations using HRA data from the two systems.

Impact of CO2 Emissions, Exchange Rate Regimes, and Political Stability on Currency Crises: Evidence from South Asian Countries

  • ULLLAH, Zia;FEN, Tan Xiao;TUNIO, Fayaz Hussain;ULLAH, Imran
    • The Journal of Asian Finance, Economics and Business
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    • 제9권2호
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    • pp.29-36
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    • 2022
  • This study uses the panel probit model to investigate and evaluate the relationship between exchange rate regimes, political stability, and carbon dioxide during currency crises. To understand currency crisis times, we study a panel dataset of seven South Asian nations that contain annual observations from 1996 to 2020. Furthermore, we created the EMPI exchange market pressure indicator to detect crises. Our results strongly suggested that fixed exchange rate is negatively associated with currency crises, with good regulatory quality and better effective governments. Simultaneously, the floating exchange rate is positively related to the currency crises in those countries where the rule of law has less adequately flowed. However, CO2, exports, and interest rates are buoyantly associated with crises. The floating exchange rate, the rule of law, exports, and interest rate are associated positively and contribute more prone to the crisis episodes. Negatively associated variables contributed less amid crises episodes: fixed exchange rate regime, government effectiveness, and regulatory quality. Meanwhile, CO2 has a positive relationship with a currency crisis and contributes more likelihood to the probability of a currency crisis. Countries that adopted the fixed exchange rates with effective governments and regulatory quality faced more minor currency crises.

SACADA and HuREX: Part 1. the use of SACADA and HuREX systems to collect human reliability data

  • Chang, Yung Hsien James;Kim, Yochan;Park, Jinkyun;Criscione, Lawrence
    • Nuclear Engineering and Technology
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    • 제54권5호
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    • pp.1686-1697
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    • 2022
  • As a part of probabilistic risk (or safety) assessment (PRA or PSA) of nuclear power plants (NPPs), the primary role of human reliability analysis (HRA) is to provide credible estimations of the human error probabilities (HEPs) of safety-critical tasks. Accordingly, HRA community has emphasized the accumulation of HRA data to support HRA practitioners for many decades. To this end, it is critical to resolve practical problems including (but not limited to): (1) how to collect HRA data from available information sources, and (2) how to inform HRA practitioners with the collected HRA data. In this regard, the U.S. Nuclear Regulatory Commission (NRC) and Korea Atomic Energy Research Institute (KAERI) independently initiated two large projects to accumulate HRA data by using full-scale simulators (i.e., simulator data). In terms of resolving the first practical problem, the NRC and KAERI developed two dedicated HRA data collection systems, SACADA (Scenario Authoring, Characterization, And Debriefing Application) and HuREX (Human Reliability data EXtraction), respectively. In addition, to inform HRA practitioners, the NRC and KAERI proposed several ideas to extract useful information from simulator data. This paper is the first of two papers to discuss the technical underpinnings of the development of the SACADA and HuREX systems.

관리대상 화학물질의 지정 및 관리체계 차등화를 통한 효율적 대학 연구실 관리에 대한 연구 (A Study on the Efficient Management of University Laboratories through Differential Designation of Chemical Substances and Classification of Management System)

  • 김덕한;김민선;이익모
    • 대한안전경영과학회지
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    • 제24권4호
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    • pp.61-70
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    • 2022
  • In spite of lab safety act for over 10 years, over 100 safety accidents in the laboratory have been constantly occurring. The ideal safety management system is to prevent accidents by differential classifying and managing laboratory regulatory materials according to the risk level. In order to approach this system, in-depth interviews with safety managers were first conducted to identify the current status of safety management in domestic university laboratories. And then through comparative analysis of safety management systems in domestic and foreign laboratories, a new regulatory substance classification standard based on the analysis of the hazards and the classification of risk grades, and a safety management system are proposed. From this study, it will contribute to the creation of a safe laboratory environment by differential classification and management laboratory regulatory materials based on the risk level.

우수 의약품 제조 기준 위반 패턴 인식을 위한 연관규칙과 텍스트 마이닝 기반 t-SNE분석 (Violation Pattern Analysis for Good Manufacturing Practice for Medicine using t-SNE Based on Association Rule and Text Mining)

  • 이준오;손소영
    • 품질경영학회지
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    • 제50권4호
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    • pp.717-734
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    • 2022
  • Purpose: The purpose of this study is to effectively detect violations that occur simultaneously against Good Manufacturing Practice, which were concealed by drug manufacturers. Methods: In this study, we present an analysis framework for analyzing regulatory violation patterns using Association Rule Mining (ARM), Text Mining, and t-distributed Stochastic Neighbor Embedding (t-SNE) to increase the effectiveness of on-site inspection. Results: A number of simultaneous violation patterns was discovered by applying Association Rule Mining to FDA's inspection data collected from October 2008 to February 2022. Among them there were 'concurrent violation patterns' derived from similar regulatory ranges of two or more regulations. These patterns do not help to predict violations that simultaneously appear but belong to different regulations. Those unnecessary patterns were excluded by applying t-SNE based on text-mining. Conclusion: Our proposed approach enables the recognition of simultaneous violation patterns during the on-site inspection. It is expected to decrease the detection time by increasing the likelihood of finding intentionally concealed violations.

OTT 도입의 규제 기준과 근거에 대한 연구 (A Study on the Regulatory Standards and Rationale of OTT Adoption)

  • 김희경;도준호
    • 한국인터넷방송통신학회논문지
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    • 제22권4호
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    • pp.141-148
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    • 2022
  • OTT 등 신규 서비스가 등장하고 미디어 산업의 가치사슬이 복잡한 지형을 형성하게 되면서 공정경쟁과 이용자 보호, 내용심의 등 다양한 문제들이 발생하고 있다. 그러나 네트워크의 물리적 특성과 기술적 요소로 사업자를 구분하는 기존법으로 OTT를 도입하는 문제는 과다한 규제와 산업 활성화 저해라는 측면에서 비판받고 있으며, 새로운 규제체계로의 도입은 플랫폼의 사회적 영향력에 대한 논란과 이해관계자와의 충돌로 장기적인 지연을 거듭하고 있다. 본 연구는 전문가들이 인식하는 기존법 내지 새로운 규제체계 하에서 OTT 도입을 위한 규제 근거와 기준에 대한 의견을 청취하고 이에 대한 타당성을 분석했다. 이와 같은 분석은 향후 OTT 도입 방식에 유의미한 시사점을 제공할 것으로 판단된다.

Z-DNA-Containing Long Terminal Repeats of Human Endogenous Retrovirus Families Provide Alternative Promoters for Human Functional Genes

  • Lee, Du Hyeong;Bae, Woo Hyeon;Ha, Hongseok;Park, Eun Gyung;Lee, Yun Ju;Kim, Woo Ryung;Kim, Heui-Soo
    • Molecules and Cells
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    • 제45권8호
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    • pp.522-530
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    • 2022
  • Transposable elements (TEs) account for approximately 45% of the human genome. TEs have proliferated randomly and integrated into functional genes during hominoid radiation. They appear as right-handed B-DNA double helices and slightly elongated left-handed Z-DNAs. Human endogenous retrovirus (HERV) families are widely distributed in human chromosomes at a ratio of 8%. They contain a 5'-long terminal repeat (LTR)-gag-pol-env-3'-LTR structure. LTRs contain the U3 enhancer and promoter region, transcribed R region, and U5 region. LTRs can influence host gene expression by acting as regulatory elements. In this review, we describe the alternative promoters derived from LTR elements that overlap Z-DNA by comparing Z-hunt and DeepZ data for human functional genes. We also present evidence showing the regulatory activity of LTR elements containing Z-DNA in GSDML. Taken together, the regulatory activity of LTR elements with Z-DNA allows us to understand gene function in relation to various human diseases.

The Improvement of China's Nuclear Safety Supervision Technical Support Ability

  • Han Wu;Guoxin Yu;Xiangyang Zheng;Keyan Teng
    • 방사성폐기물학회지
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    • 제20권4호
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    • pp.523-531
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    • 2022
  • The International Atomic Energy Agency (IAEA) entails independent decision-making for the safety supervision of civil nuclear facilities. To evaluate and review the safety of nuclear facilities, the national regulatory body usually consults independent institutions or external committees. Technical Support Organizations (TSOs) include national laboratories, research institutions, and consulting organizations. Support from professional organizations in other countries may also be required occasionally. Most of the world's major nuclear power countries adopt an independent nuclear safety supervision model. Accordingly, China has continuously improved upon the construction of such a system by establishing the National Nuclear Safety Administration (NNSA) as the decision-making department for nuclear and radiation safety supervision, six regional safety supervision stations, the Nuclear and Radiation Safety Center (NSC), a nuclear safety expert committee, and the National Nuclear and Radiation Safety Supervision Technology R&D Base, which serves as the test, verification, and R&D platform for providing consultation and technical support. An R&D system, however, remains to be formed. Future endeavors must focus on improving the technical support capacity of these systems. As an enhancement from institutional independence to capability independence is necessary for ensuring the independence of China's nuclear safety regulatory institution, its regulatory capacity must be improved in the future.

신장이식 분야의 세포 면역치료 (Cell Therapy in Kidney Transplantation)

  • 전희중;양재석
    • 대한이식학회지
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    • 제28권3호
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    • pp.121-134
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    • 2014
  • Current immunosuppressants have nonspecific immuosuppressive effects, and are not helpful for tolerance induction. Consequently, transplant patients cannot discontinue using them, and their nonspecific immunosuppressive effects result in many side effects, including infection and malignancy. However, most of cellular immunotherapy can have donor antigen-specific immunsuppressive effects. Therefore, cell therapy could be an alternative or adjunctive to nonspecific immunosuppressants. Polyclonal or antigen-specific Foxp3+ regulatory T cells have been actively tried for prevention of acute rejection, treatment of chronic rejection, or tolerance induction in clinical trials. Regulatory macrophages are also under clinical trials for kidney transplant patients. IL-10-secreting type 1 regulatory T cells and donor- or recipient-derived tolerogenic dendritic cells will also be used for immunoregulation in clinical trials of kidney transplantation. These cells have antigen-specific immunoregulatory effects. Mesenchymal stromal cells (MSCs) have good proliferative capacity and immunosuppressive actions independently of major histocompatibility complex; therefore, even third-party MSCs can be stored and used for many patients. Cell therapy using various immunoregulatory cells is now promising for not only reducing side effects of nonspecific immunosuppressants but also induction of immune tolerance, and is expected to contribute to better outcomes in transplant patients.

Modeling cryptographic algorithms validation and developing block ciphers with electronic code book for a control system at nuclear power plants

  • JunYoung Son;Taewoo Tak;Hahm Inhye
    • Nuclear Engineering and Technology
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    • 제55권1호
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    • pp.25-36
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    • 2023
  • Nuclear power plants have recognized the importance of nuclear cybersecurity. Based on regulatory guidelines and security-related standards issued by regulatory agencies around the world including IAEA, NRC, and KINAC, nuclear operating organizations and related systems manufacturing organizations, design companies, and regulatory agencies are considering methods to prepare for nuclear cybersecurity. Cryptographic algorithms have to be developed and applied in order to meet nuclear cybersecurity requirements. This paper presents methodologies for validating cryptographic algorithms that should be continuously applied at the critical control system of I&C in NPPs. Through the proposed schemes, validation programs are developed in the PLC, which is a critical system of a NPP's I&C, and the validation program is verified through simulation results. Since the development of a cryptographic algorithm validation program for critical digital systems of NPPs has not been carried out, the methodologies proposed in this paper could provide guidelines for Cryptographic Module Validation Modeling for Control Systems in NPPs. In particular, among several CMVP, specific testing techniques for ECB mode-based block ciphers are introduced with program codes and validation models.