• Title/Summary/Keyword: risk assessment regulation

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Application of Toxicogenomic Technology for the Improvement of Risk Assessment

  • Hwang, Myung-Sil;Yoon, Eun-Kyung;Kim, Ja-Young;Son, Bo-Kyung;Jang, Dong-Deuk;Yoo, Tae-Moo
    • Molecular & Cellular Toxicology
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    • v.4 no.3
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    • pp.260-266
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    • 2008
  • Recently, there has been scientific discussion on the utility of -omics techniques such as genomics, proteomics, and metabolomics within toxicological research and mechanism-based risk assessment. Toxicogenomics is a novel approach integrating the expression analysis of genes (genomic) or proteins (proteomic) with traditional toxicological methods. Since 1999, the toxicogenomic approach has been extensively applied for regulatory purposes in order to understand the potential toxic mechanisms that result from chemical compound exposures. Therefore, this article's purpose was to consider the utility of toxicogenomic profiles for improved risk assessment, explore the current limitations in applying toxicogenomics to regulation, and finally, to rationalize possible avenues to resolve some of the major challenges. Based on many recent works, the significant impact toxicogenomic techniques would have on human health risk assessment is better identification of toxicity pathways or mode-of-actions (MOAs). In addition, the application of toxicogenomics in risk assessment and regulation has proven to be cost effective in terms of screening unknown toxicants prior to more extensive and costly experimental evaluation. However, to maximize the utility of these techniques in regulation, researchers and regulators must resolve many parallel challenges with regard to data collection, integration, and interpretation. Furthermore, standard guidance has to be prepared for researchers and assessors on the scientifically appropriate use of toxicogenomic profiles in risk assessment. The National Institute of Toxicological Research (NITR) looks forward to an ongoing role as leader in addressing the challenges associated with the scientifically sound use of toxicogenomics data in risk assessment.

Lightning Risk Assessment for Structures Lower than 20m High (높이 20미터 미만인 구조물의 낙뢰리스크 평가)

  • Lee, Ju-Chul;Kim, Gi-Hyun;Lee, Young-Chul
    • Journal of the Korean Institute of Illuminating and Electrical Installation Engineers
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    • v.26 no.12
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    • pp.21-27
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    • 2012
  • Korean Industrial Standards for lightning protection system complies with IEC standards. However, the standards are applicable only to buildings and structures more than 20 meters in high. Therefore, it is necessary to determine whether lightning protection system should be installed on structures lower than 20 meters high. This paper proposes an efficient method of assessing risk against lightning of structures lower than 20 meters high. The method suggests simplified lightning protection system and provides selecting an appropriate protection level. The suggested method assumes that structure under assessment has no lightning protection system and there is no person around the structure at the moment of lightning stroke. A simplified method of assessing the risk to human within the structure is developed by adopting the general assessment factor. The selection of a protection level is possible by comparing tolerable risk with physical damage risk caused by a direct lightning. Finally, this paper gives ways to establish surge protection measures when a structure with lightning risk is within a radius of 2km from the assessed structure even if this structure requires no lightning protection system.

Developing a New Risk Assessment Methodology for Distribution System Operators Regulated by Quality Regulation Considering Reclosing Time

  • Saboorideilami, S.;Abdi, Hamdi
    • Journal of Electrical Engineering and Technology
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    • v.9 no.4
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    • pp.1154-1162
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    • 2014
  • In the restructured electricity market, Performance-Based Regulation (PBR) regime has been introduced to the distribution network. To ensure the network stability, this regime is used along with quality regulations. Quality regulation impose new financial risks on distribution system operators (DSOs). The poor quality of the network will result in reduced revenues for DSOs. The mentioned financial risks depend on the quality indices of the system. Based on annual variation of these indices, the cost of quality regulation will also vary. In this paper with regard to reclosing fault in distribution network, we develop a risk-based method to assess the financial risks caused by quality regulation for DSOs. Furthermore, in order to take the stochastic behavior of the distribution network and quality indices variations into account, time-sequential Monte Carlo simulation method is used. Using the proposed risk method, the effect of taking reclosing time into account will be examined on system quality indicators and the cost of quality regulation in Swedish rural reliability test system (SRRTS). The results show that taking reclosing fault into consideration, affects the system quality indicators, particularly annual average interruption frequency index of the system (SAIFI). Moreover taking reclosing fault into consideration also affects the quality regulations cost. Therefore, considering reclosing time provides a more realistic viewpoint about the financial risks arising from quality regulation for DSOs.

A Study on the Effectiveness of the Risk Assessment Regulations for Construction Works (건설공사 유해위험방지계획서제도의 효과분석에 관한 연구)

  • 안홍섭;노민래;이명구
    • Journal of the Korean Society of Safety
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    • v.16 no.4
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    • pp.134-139
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    • 2001
  • The Risk assessment regulation(RAR) is one of the essential articles of the Occupational safety and health law for the construction industry along with safety and health management expense and safety organization regulation. However, arguments regarding the working time of the safety assessment documents, the person in charge of documentation, weakness in legislative enforcement etc. are ongoing. Thus this study aims to analyze the effectiveness of RAR for the guidance of enhancing the effectiveness of RAR. The findings are; 1) the effectiveness of RAR is recognized, however the indirect effectiveness ie, enforcement of safety activities, previewing of drawings etc. are bigger than the direct effectiveness of accident prevention, 2) to enhance the effectiveness of RAR site inspection procedure has to be utilized, 3) further research for identifying and getting rid of negative factors in RAR is recommended.

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ISSUES IN FORMULATING PERFORMANCE-BASED APPROACHES TO REGULATORY OVERSIGHT OF NUCLEAR POWER PLANTS

  • YOUNGBLOOD R. W.;KIM I. S.
    • Nuclear Engineering and Technology
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    • v.37 no.3
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    • pp.231-244
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    • 2005
  • In recent decades, significant effort has led to risk-informed improvements to regulation. Performance-based approaches also promise significant gains in efficiency (level of safety versus effort). However, significant work remains to be done before performance-based approaches realize their full potential in regulation of nuclear power plants. This paper reviews key concepts related to performance-based regulation, discusses some applications of performance-based approaches, and identifies issues that still need to be addressed. Realistic, experience-based models of licensee performance are still lacking; this makes it difficult to assess the prospective effectiveness of any given regulatory approach, in light of the performance issues that it will actually face. Also, while 'compliance' is an intuitively straightforward concept to apply within a prescriptive implementation, its analog in a performance-based approach remains unclear. An overarching theme of the paper is that formal methods of decision analysis are very helpful in developing appropriate regulatory approaches, especially performance-based ones; this theme is illustrated at several points.

Development of Risk Assessment Method for Cobot Workplace and Regulation Response (협동로봇 설치작업장 위험성평가 방법 개발 및 규제 대응)

  • Jun, Jinwoo;Ryu, Joel;Kim, Kunok;Kim, Hoichoon
    • The Journal of Korea Robotics Society
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    • v.14 no.4
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    • pp.333-339
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    • 2019
  • Cobots are industrial robots with greatly enhanced safety functions that enable them to work in the same space with workers without protector. Cobots are regulated by the Industrial Safety and Health Act and must be certified according to the manufacturing stage, installation stage and usage stage. The ISO 10218-2 standard applied in the installation phase is difficult to apply in the field. Therefore, it is necessary to develop a risk assessment method based on ISO 12100 standard. This paper proposes a new methodology that combines 'JSA' and 'What-if', which reflects the human error and the lack of known risk factors. Accordingly, a new risk assessment template was proposed and the effectiveness of the developed new template was examined. The current cobot safety regulations need to be unified with safety inspections scheme, and robot safety experts and infrastructures need to be expanded and Robot safety regulations should be unified to 'Robot Act'. Based on this research, risk assessment methods suitable for the field need to be developed additionally, and robot safety regulation needs to be transformed to promote the industry.

PRA RESEARCH AND THE DEVELOPMENT OF RISK-INFORMED REGULATION AT THE U.S. NUCLEAR REGULATORY COMMISSION

  • Siu, Nathan;Collins, Dorothy
    • Nuclear Engineering and Technology
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    • v.40 no.5
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    • pp.349-364
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    • 2008
  • Over the years, probabilistic risk assessment (PRA) research activities conducted at the U.S. Nuclear Regulatory Commission (NRC) have played an essential role in support of the agency's move towards risk-informed regulation. These research activities have provided the technical basis for NRC's regulatory activities in key areas; provided PRA methods, tools, and data enabling the agency to meet future challenges; supported the implementation of NRC's 1995 PRA Policy Statement by assessing key sources of risk; and supported the development of necessary technical and human resources supporting NRC's risk-informed activities. PRA research aimed at improving the NRC's understanding of risk can positively affect the agency's regulatory activities, as evidenced by three case studies involving research on fire PRA, human reliability analysis (HRA), and pressurized thermal shock (PTS) PRA. These case studies also show that such research can take a considerable amount of time, and that the incorporation of research results into regulatory practice can take even longer. The need for sustained effort and appropriate lead time is an important consideration in the development of a PRA research program aimed at helping the agency address key sources of risk for current and potential future facilities.

Assessment of Chemical Risks in Moroccan Medical Biology Laboratories in Accordance with the CLP Regulation

  • Mourry, Ghita E.;Alami, Rachid;Elyadini, Adil;Hajjaji, Souad El;kabba, Saad El;Zouhdi, Mimoun
    • Safety and Health at Work
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    • v.11 no.2
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    • pp.193-198
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    • 2020
  • Background: Medical laboratory workers are frequently exposed to a wide range of chemicals. This exposure can have adverse effects on their health. Furthermore, a knowledge lack of the chemical risk increases the likelihood of exposure. The chemical risk assessment reduces the risk of exposure to hazardous chemicals and therefore, guarantees health and safety of the workers. Method: The chemical risk assessment was conducted using a modified INRS method, according to the new CLP Regulation, of 11 unit laboratories in a Moroccan medical laboratory. Observation of each workstation and analysis of safety data sheets are key tools in this study. Results: A total of 144 substances and reagents that could affect the health of the analytical technicians were identified. Among these products, 17% are concerned by the low priority risk score, with 55% concerned by the average priority risk score and 28% concerned by the high priority risk score. This study also enabled to better identify the chemical agents that have restrictive occupational exposure limit value and controls were conducted to this effect. On the basis of the results obtained, several corrective and preventive measures have been proposed and implemented. Conclusion: Risk assessment is essential to ensure the health and safety of workers and to meet regulatory requirements. It enables to identify all the risky manipulations and to adopt appropriate preventive measures. However, it is not a one-time activity but it must be continuous in order to master the changes and thus ensure the best safety of all.

Health and Ecological Risk Assessment of PCBs-exposure by Regulation Guideline Change (규제기준 변화에 다른 PCBs 인체 및 생태 위해성 평가)

  • Lim, Young-Wook;Yang, Ji-Yeon;Jung, Jong-Soo;Lee, Yong-Jin;Kim, Jin-Young;Lee, Chung-Soo;Ko, Seong-Joon;Shin, Dong-Chun
    • Environmental Analysis Health and Toxicology
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    • v.23 no.1
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    • pp.53-62
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    • 2008
  • In the present study, the concentration levels of polychlorinated biphenyls (or PCBs) in the environments in Korea are estimated based on some measured data in Korea, in comparison with the data from the other countries. Even though PCBs were banned as electrical fluids in 1970s in Korea, PCBs are still detected in the environment. PCBs levels in Korea are greatly lower than those in other countries, which are gradually decreased as well. However, the measured data are not sufficient in both numbers and quality, to estimate the average PCBs levels in Korea. The regulation limit on polychlorinated biphenyls (or PCBs) is 2mg/kg (ppm), which is too low compared to 50 ppm of many other countries including U.S. With this strict regulation, there are many problems expected, for example, in the analysis of PCBs in the transformers using in the field as well as the safe treatment of PCBs. The risk assessment on the PCBs in the environment is surely necessary prior to the change in the limit. Also the PCBs concentration monitoring in the environmental media (i.e. air, water, soil and sediment) and exposure assessment will be essential for the accurate risk assessment. If the PCB-waste guideline maintain as 2 ppm after 10 years, the excess cancer risk of PCBs exposure by ambient air, drinking water and soil was $10^{-8}$. But if the guideline mitigate as 50 ppm after 10 years, the cancer risk was increased by $10^{-7}$. The ecological risk quotient by regulation change was not exceed '1'.

Quantitative Approaches in Use to Assess Cancer Risk

  • Anderson Elizabeth L.
    • 대한예방의학회:학술대회논문집
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    • 1994.02a
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    • pp.450-468
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    • 1994
  • Scientists have long used conventional toxicological methods to establish 'safe levels of exposure' for chemicals presumed to have threshold health effects or doses below which significant effects are unlikely to occur. These same methods cannot be used to establish safe levels of exposure for non-threshold pollutants. such as carcinogens. Therefore. Federal regulatory agencies in the United States are using risk assessment methods to provide information for public health policy decisions concerning increases in risk associated with increases in exposure to carcinogenic and other non-threshold pollutants. Acceptable exposure/risk levels are decided by policymakers who consider descriptions and estimates of risks together with social and economic benefits from the uses of the chemical. 1bis paper focuses on the development of quantitative risk assessment approaches by Federal regulatory agencies in the United States, and identifies the mathematical models currently being used for risk extrapolation. including their inherent uncertainties. The uncertainties and limitations of these methods have led some scientists to question the utility of quantitative risk extrapolation. The experience of the; U.S. Environmental Protection Agency (EPA). as summarized in this paper. can provide a realistic basis for evaluating the pros and cons. Finally. shortcomings in current risk assessment methods and their use in policy decisions are explored. and areas for possible improvement. given current scientific knowledge. are identified.

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