• Title/Summary/Keyword: Regulatory Guide

검색결과 112건 처리시간 0.025초

외래 DNA단편이 잔존하지 않는 유전자교정식물에 대한 GMO규제 범위의 제외에 관한 국제 동향 (Current status on the modification of the scope for GMO regulation on the gene edited plants with no remnants of inserted foreign DNA fragments)

  • 이신우
    • Journal of Plant Biotechnology
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    • 제46권3호
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    • pp.137-142
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    • 2019
  • 유전자교정작물은 공여 DNA의 사용 여부와 돌연변이의 크기에 따라 SDN-1, SDN-2, SDN-3 작물로 분류한다. 특히 SDN-1과 SDN-2 작물들은 이들을 창출하기 위하여 사용한 운반체 DNA 단편 또는 guide RNA가 잔존 하지 않는 100% transgene-free 작물의 개발이 가능하다. 따라서 이들은 기존의 전통교배육종기술을 이용하거나 자연 상태에서도 창출이 가능한 작물들이다. 그러므로 기존의 GMO 법령에 따라 이들 유전자교정작물을 판별하거나 표시제에 근거한 관리 감독을 수행하기가 어렵다. 이러한 과학적 사실에 근거하여 호주는 SDN-1 작물은 GMO 규제에서 제외하도록 하였다. 또한, 아르헨티나, 브라질, 일본 등은 외래유전자가 최종산물에 잔존 하지 않는 유전자교정작물은 GMO 규제에서 제외하도록 하여 SDN-1은 물론 SDN-2 작물도 GMO에 포함되지 않을 수도 있도록 하였다. 이러한 추세에 따라 우리나라도 외래유전자가 잔존 하지 않는 유전자교정작물은 GMO 규제에서 제외하도록 하여 유전자교정기술을 이용한 다양한 작물 육종 계통 육성이 널리 이용되어 우수 품종 육성에 기여되길 기대한다.

공간정보데이터의 효율적인 민관 파트너쉽 방안 - 서울시 추진사례를 중심으로 - (The Efficient Public Private Partnerships for the Geospatial Data)

  • 고준환;김문기
    • Spatial Information Research
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    • 제20권2호
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    • pp.71-79
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    • 2012
  • 본 연구에서는 지자체에서 최초로 공간정보데이터에 대해서 민관협력을 추진한 서울시의 사례를 중심으로 연구를 하였으며, 중앙부처 및 기타 지자체에게 공간정보데이터의 민관협력을 통해서 얻어진 노하우를 제공하기 위한 좋은 참조자료가 될 수 있도록 실질적이고 유용한 연구 자료를 제공하는데 본 연구의 목적이 있다. 공간정보에 대해서 민간과 공공이 협의체를 구성하여 지속적으로 협의를 통해서 개선해야 할 사항을 논의해야 할 것이며, 공동으로 법적 제도적인 사항을 관계기관에게 제출하여서 개선을 해야 할 것 이다. 또한, 민간과 공공기관과의 시각에 대한 전환을 가져야 할 것이다. 서울시에서 추진한 민간과의 협력을 통해 구축된 공간정보데이터를 민관 공동 구축 및 활용 통하여 예산절감 및 효율적인 방안을 모색하고, 제도를 개선하여 활성화할 수 있도록 방안을 제시하는데 있다. 관련된 법령의 미비와 폐쇄적인 제도로 인하여 실무적인 실행에 어려움을 겪는 부분에 대해서, 서울시는 이를 극복하는 노하우를 제시하여 중앙부처 및 지자체에서 참조할 만한 가이드를 제시하고자 한다.

구조물 및 기기의 내진성능 평가를 위한 고주파수 지진에 의한 원자력발전소의 지진응답 증폭계수 (Seismic Response Amplification Factors of Nuclear Power Plants for Seismic Performance Evaluation of Structures and Equipment due to High-frequency Earthquakes)

  • 임승현;최인길;전법규;곽신영
    • 한국지진공학회논문집
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    • 제24권3호
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    • pp.123-128
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    • 2020
  • Analysis of the 2016 Gyeongju earthquake and the 2017 Pohang earthquake showed the characteristics of a typical high-frequency earthquake with many high-frequency components, short time strong motion duration, and large peak ground acceleration relative to the magnitude of the earthquake. Domestic nuclear power plants were designed and evaluated based on NRC's Regulatory Guide 1.60 design response spectrum, which had a great deal of energy in the low-frequency range. Therefore, nuclear power plants should carry out seismic verification and seismic performance evaluation of systems, structures, and components by reflecting the domestic characteristics of earthquakes. In this study, high-frequency amplification factors that can be used for seismic verification and seismic performance evaluation of nuclear power plant systems, structures, and equipment were analyzed. In order to analyze the high-frequency amplification factor, five sets of seismic time history were generated, which were matched with the uniform hazard response spectrum to reflect the characteristics of domestic earthquake motion. The nuclear power plant was subjected to seismic analysis for the construction of the Korean standard nuclear power plant, OPR1000, which is a reactor building, an auxiliary building assembly, a component cooling water heat exchanger building, and an essential service water building. Based on the results of the seismic analysis, a high-frequency amplification factor was derived upon the calculation of the floor response spectrum of the important locations of nuclear power plants. The high-frequency amplification factor can be effectively used for the seismic verification and seismic performance evaluation of electric equipment which are sensitive to high-frequency earthquakes.

ESTIMATION OF OFF-SITE DOSE AND RELEASE CONCENTRATION OF RADIOACTIVE LIQUID EFFLUENTS FROM RADWASTE TREATMENT SYSTEM IN KORI 3&4

  • Kim, H.S.;Son, J.K.;Kim, K.D.;Ha, J.H.;Song, M.J.
    • Journal of Radiation Protection and Research
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    • 제26권3호
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    • pp.291-298
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    • 2001
  • The designed release rate of liquid effluents from radwaste treatment system should be calculated and evaluated during normal operation, including anticipated operational occurrence and be assured that the release concentration and off-site dose at unrestricted area do not exceed the limits of regulation. The expected annual release rate and off-site dose for the currently operating nuclear power plants in Korea had been calculated and evaluated using PWR-GALE and LADTAP-II which was based on USNRC Regulatory Guide 1.109. Recently, the MOST Notice 2001-2 related to release concentration and off-site dose at unrestricted area was revised to reflect the concept of ICRP-60. It is necessary for KORI 3&4 to re-calculate the release concentration and off-site dose and to compare these results with the limits of regulation. As the results of assessment, we confirmed that the release concentrations were less than its limits of MOST Notice 2001-2 and the off-site dose at unrestricted area using K-DOSE60 was 3.61E-03 mSv/yr to the age of five for the effective dose, and 4.10E-2 mSv/yr to thyroid of the age of five for the organ equivalent dose. We also confirmed the off-site dose was within the limits of MOST Notice 2001-2. Therefore, the release concentration and off-site dose re-evaluated at unrestricted area in KORI 3&4 were well below the regulation limits of MOST Notice 2001-2.

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Euchromatin histone methyltransferase II (EHMT2) regulates the expression of ras-related GTP binding C (RRAGC) protein

  • Hwang, Supyong;Kim, Soyoung;Kim, Kyungkon;Yeom, Jeonghun;Park, Sojung;Kim, Inki
    • BMB Reports
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    • 제53권11호
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    • pp.576-581
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    • 2020
  • Dimethylation of the histone H3 protein at lysine residue 9 (H3K9) is mediated by euchromatin histone methyltransferase II (EHMT2) and results in transcriptional repression of target genes. Recently, chemical inhibition of EHMT2 was shown to induce various physiological outcomes, including endoplasmic reticulum stress-associated genes transcription in cancer cells. To identify genes that are transcriptionally repressed by EHMT2 during apoptosis, and cell stress responses, we screened genes that are upregulated by BIX-01294, a chemical inhibitor of EHMT2. RNA sequencing analyses revealed 77 genes that were upregulated by BIX-01294 in all four hepatic cell carcinoma (HCC) cell lines. These included genes that have been implicated in apoptosis, the unfolded protein response (UPR), and others. Among these genes, the one encoding the stress-response protein Ras-related GTPase C (RRAGC) was upregulated in all BIX-01294-treated HCC cell lines. We confirmed the regulatory roles of EHMT2 in RRAGC expression in HCC cell lines using proteomic analyses, chromatin immune precipitation (ChIP) assay, and small guide RNA-mediated loss-of-function experiments. Upregulation of RRAGC was limited by the reactive oxygen species (ROS) scavenger N-acetyl cysteine (NAC), suggesting that ROS are involved in EHMT2-mediated transcriptional regulation of stress-response genes in HCC cells. Finally, combined treatment of cells with BIX-01294 and 5-Aza-cytidine induced greater upregulation of RRAGC protein expression. These findings suggest that EHMT2 suppresses expression of the RRAGC gene in a ROS-dependent manner and imply that EHMT2 is a key regulator of stress-responsive gene expression in liver cancer cells.

신형경수로 1400 종합진동평가프로그램 측정시험 계획 (Comprehensive Vibration Assessment Program Measurement Test Plan for Advanced Power Reactor 1400)

  • 고도영;김규형
    • 한국소음진동공학회:학술대회논문집
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    • 한국소음진동공학회 2013년도 춘계학술대회 논문집
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    • pp.589-595
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    • 2013
  • 미국 원자력규제위원회 규제지침(US NRC RG) 1.20의 비원형범주(non-prototype category)-2를 기준으로 신형경수로 1400(APR1400) 원자로내부구조물(RVI)의 설계수명기간 동안 건전성이 확보될 수 있는지를 확인하기 위해 종합진동평가프로그램(CVAP)을 수행하고 있다. US NRC RG 1.20의 비원형범주-2는 진동 및 응력 해석프로그램, 제한적 진동 측정프로그램, 검사프로그램 그리고 이런 프로그램들의 비교, 평가로 구성된다. 이 논문은 APR1400 RVI CVAP 측정프로그램의 측정계획, 시험, 허용기준과 결과 및 문서화에 대한 내용을 기술하였다. 우리는 이 논문의 진동측정 계획 및 시행에 따라서 APR1400 RVI CVAP 제한적 진동 측정프로그램을 수행할 것이다.

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CDISC Transformer: a metadata-based transformation tool for clinical trial and research data into CDISC standards

  • Park, Yu-Rang;Kim, Hye-Hyeon;Seo, Hwa-Jeong;Kim, Ju-Han
    • KSII Transactions on Internet and Information Systems (TIIS)
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    • 제5권10호
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    • pp.1830-1840
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    • 2011
  • CDISC (Clinical Data Interchanging Standards Consortium) standards are to support the acquisition, exchange, submission and archival of clinical trial and research data. SDTM (Study Data Tabulation Model) for Case Report Forms (CRFs) was recommended for U.S. Food and Drug Administration (FDA) regulatory submissions since 2004. Although the SDTM Implementation Guide gives a standardized and predefined collection of submission metadata 'domains' containing extensive variable collections, transforming CRFs to SDTM files for FDA submission is still a very hard and time-consuming task. For addressing this issue, we developed metadata based SDTM mapping rules. Using these mapping rules, we also developed a semi-automatic tool, named CDISC Transformer, for transforming clinical trial data to CDISC standard compliant data. The performance of CDISC Transformer with or without MDR support was evaluated using CDISC blank CRF as the 'gold standard'. Both MDR and user inquiry-supported transformation substantially improved the accuracy of our transformation rules. CDISC Transformer will greatly reduce the workloads and enhance standardized data entry and integration for clinical trial and research in various healthcare domains.

면소판결사유(免訴判決事由)의 범위(範圍) (Range of Cause for Dismissal Judgement)

  • 이존걸
    • 한국콘텐츠학회논문지
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    • 제11권5호
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    • pp.302-307
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    • 2011
  • 현행 형사소송법은 제326조에 면소사유를 규정하여 소송조건이 이에 해당할 때에는 면소의 판결을 하도록 하고 있다. 그러나 이러한 규정을 제한적 규정으로 볼 것인가 또는 예시적 규정으로 볼 것인가가 문제된다. 어떻게 보느냐에 따라 면소판결사유의 범위가 달라지기 때문이다. 따라서 이에 대한 고찰을 할 필요성이 있다. 고찰결과 면소사유는 제326조에 규정된 사유에 제한하는 것이 타당하다. 공소권남용 등 비전형적 소송장애사유들은 제327조 2호의 공소기각판결들을 하면 되고, 굳이 법률규정에도 없는 사항을 면소판결의 사유라고 자의적으로 적용하여 위헌의 소지를 남길 필요가 없기 때문이다. 또한 공소기각판결은 공소제기의 절차가 법률에 위반하여 무효인 때라고 규정함으로써 일반조항의 성격을 갖고 있기 때문에 유연한 해석의 길이 열려있는데 비해서 면소의 규정은 그렇지 않기 때문이다. 따라서 제326조에 규정된 사유는 어디까지나 제한규정이라고 보아 비전형적 소송조건은 면소사유에 포함시켜서는 안 된다.

펌프 맥동하중에 대한 노심지지배럴 집합체의 음향-구조 연성해석 (Acoustic Structure Interaction Analysis of the Core Support Barrel for Pump Pulsation Loads)

  • 이장원;문종성;김정규;성기광;김현민
    • 대한기계학회논문집 C: 기술과 교육
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    • 제5권2호
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    • pp.127-134
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    • 2017
  • 원자로내부구조물은 다양한 진동하중조건에서 안전성과 건전성을 유지해야한다. 그러므로 미국원자력규제 위원회는 펌프 압력 맥동에 의한 진동을 포함하여 음향으로 유발되는 진동을 평가하기 위한 규제지침서 1.20을 제시하고 있다. 본 논문은 음향-구조 연성해석 기법을 사용하여 펌프 맥동 가진으로 인한 해석을 위해 노심지지배럴 주변의 유체와 구조의 연성을 고려하여 해석하는 방법론을 제안하였다. 해석결과는 미국 Palo Verde 1호기 종합진동평가 프로그램 발전소 시험결과와 잘 일치한다. 따라서 제안된 해석 방법론은 펌프 압력맥동에 대한 노심지지배럴의 구조응답을 평가하기 위한 효과적 방법으로 판단된다.

흰쥐에서 배측 봉선핵의 전기자극이 췌장의 외분비기능에 미치는 영향 (Exocrine Pancreatic Secretion in Response to Electrical Stimulation of Dorsal Raphe Nucleus in Rats)

  • 서상원;박형진
    • The Korean Journal of Physiology
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    • 제24권2호
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    • pp.403-411
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    • 1990
  • The present investigation was performed to see a possible influence of the dorsal raphe nucleus (DRN) on pancreatic exocrine secretion in anesthetized rats since the DRN had been known to exert a regulatory mechanism on sympathetic activity which was known to be very important for pancreatic exocrine secretion, particularly in rats. Twenty-nine Sprague-Dawley rats fasted for 24 hours were anesthetized by i.p. injection of 1 g/kg of urethane. The pancreatic duct was cannulated to collect pancreatic juice while bile juice was diverted into the jejunum. The duodenopyloric junction was tightly ligated. After surgery for collection of pancreatic exocrine secretion and recording of carotid blood pressure, a coaxial electrode was stereotaxically inserted in the DRN with a guide of a brain atlas. And then, electrical stimulus of biphasic square wave with 2 v, 2 msec, 40 Hz was applied on the electrode for 10 minutes. Pancreatic volume flow and protein output secreted in 10 min were measured. Either bilateral cervical vagotomy or spinal cord transection at the level of $C4{\sim}C5$ was performed 20 min prior to stimulation of the DRN. 1) Electrical stimulation of the DRN resulted in significant (p<0.05) increase in pancreatic volume flow and protein output. These stimulatory effects were not affected by cervical vagotomy but completely abolished by cervical cord transection. 2) Electrical stimulation of the DRN also resulted in significant (p<0.05) rise of blood pressure of the carotid artery. The hypertensive effect was not affected by cervical vagotomy but completely abolished by cervical cord transection. The results strongly suggest that the DRN, a part of the central serotonergic system, could exert a stimulatory influence on pancreatic exocrine secretion by increasing the sympathetic activity in anesthetized rats.

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