• Korean Journal of Clinical Pharmacy
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• v.31 no.4
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• pp.257-267
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• 2021

Background: The need for regulatory science development to evaluate advanced regulatory products is gradually increasing without hindering the technological development. Creating a research environment and fostering experts through the establishment of regulatory agency-led policies are essential for the development of regulatory science. Method: This is a comparative study of the United States, Japan, Singapore, and Korea. The literature and websites of each regulatory agency were reviewed, and the focus was on advantages and comparing advantages based on definition, development trends, and expert training projects. Results: The United States is striving to develop regulatory science in response to changes in the new pharmaceutical industry through the regulatory science report, and to foster expert both inside and outside the Food and Drug Administration (FDA). Japan is promoting regulatory science centered on regulatory science centers, and is focusing on researching work-related regulatory science within the Pharmaceuticals and Medical Devices Agency (PMDA) and improving employees' ability to make regulatory decisions. Singapore was aiming to improve Southeast Asia's regulatory capabilities under the leadership of Centre of Regulatory Excellence (CoRE) within Duke-NUS University. In 2021, Korea is in its early stages, starting to run a university's degree program related to regulatory science this year. Conclusion: Regulatory science should be developed with the aim of improving the regulatory ability of the Ministry of Food and Drug Safety with Korea's independent concept of regulatory science.

• Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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• v.6 no.4
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• pp.357-368
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• 2008

On July 31, 2008, the Government issued the construction and operation permit for the first low and intermediate level radioactive waste disposal facility in the Republic of Korea. In this paper, the fundamental regulatory framework, regulatory requirements and technical standards of the disposal facility are introduced, and the phased review process adopted for evaluation of the safety of the facility is briefly described. The Atomic Energy Act sets forth a stepwise regulatory framework for the whole life-cycle of the disposal facility such as siting, design, construction, operation, closure and institutional control. More detailed regulatory requirements and technical standards are stipulated in the subsequent regulations of the Atomic Energy Act and a series of Notices issued by the Ministry of Eduction, Science and Technology. The Korea Institute of Nuclear Safety, as entrusted by the Ministry under the Atomic Energy Act, conducted safety review on the disposal facility, and evaluated the compliance with relevant criteria in all technical elements(i.e. siting and structural safety, radiological environmental impact, operational safety, systems and components, quality assurance, and total systematic performance assessment, etc.). The overall safety review process can be phased into inception phase, initial review phase, main review phase and completion phase. The review results were reported to and deliberated by the five Sub-committees of the Special Committee on Nuclear Safety, and then reported to the Ministry. The Ministry issued the construction and operation permit of the disposal facility through the deliberation of the review results by the Nuclear Safety Commission. Hereafter, the safety of the repository will be reassured by a series of subsequent regulatory inspections and reviews under the Atomic Energy Act. In addition, the licensee's continuous implementation of the "Safety Promotion Plan" may also enhance the long-term safety of the repository and contribute to build-up the confidence of the safety case.

• Journal of Food Hygiene and Safety
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• v.38 no.1
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• pp.1-11
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• 2023

Skin sanitizers are effective in killing or removing pathogenic microbial contaminants from the skin of food handlers, and the progressive growth of consumer interest in personal hygiene tends to drive product diversification. This review covers the advances in the application of efficacy tests for hand sanitizers to suggest future perspectives to establish an assessment system that is optimized to each product type (gel, liquid, and wipes). Previous research on the in vivo simulative test of actual consumer use has adopted diverse experimental conditions regardless of the product type. This highlights the importance of establishing optimal test protocols specialized for the compositional characteristics of sanitizers through the comparative analysis of test methods. Although the operational conditions of the mechanical actions associated with wiping can affect the efficacy of the removal and/or the inactivation of target microorganisms from the skin's surface, currently there is a lack of standardized use patterns for the exposure of hand sanitizing wipes to skin. Thus, major determinants affecting the results from each step of the overall assessment procedures [pre-treatment - exposure of sanitizers - microbial recovery] should be identified to modify current protocols and develop novel test methods. The ex vivo test, designed to overcome the limited reproducibility of in vivo human trials, is also expected to replicate the environment for the contact of sanitizers targeting skin microorganisms. Recent progress in the area of skin microbiome research revealed distinct microbial characteristics and distribution patterns after the application of sanitizers on hands to establish the test methods with the perspectives on the antimicrobial effects at the community level. The future perspectives presented in this study on the improvement of efficacy test methods for hand sanitizers can also contribute to public health and food safety through the commercialization of effective sanitizer products.

• Journal of the Korean Society of Marine Environment & Safety
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• v.28 no.spc
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• pp.44-49
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• 2022

It is necessary to establish a marine environment management system in Korea for hazardous noxious substances (HNS) effluent from marine industrial facilities because the Marine Environment Management Act primarily focuses on pollution control from vessels and offshore man-made structures. In this study, we investigated the effluent guidelines of foreign cases focusing on the US Environmental Protection Agency (US EPA), which provides detailed information on the action levels and establishing principles for the industrial wastewater discharge of HNS. Based on the review, we also considered appropriate options for establishing new guidelines for Korea.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.16 no.10
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• pp.6905-6916
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• 2015

The primary purpose of this paper is to find out the environmental regulation in our global society with complex system concept. After the industrial revolution, there were working toward solving various problems while there has been an industry advancement. But, there are various issues that a simple international trade or economic technologic levels were not solved. The evolution of technologies through complex systemic thought are not accidental issues. These issues build and provide a predictable technology innovation that system was emergent a new order. With complex systemic thought, the earth that was facing environmental problems was in the phrase edge of chose. These conditions played the trigger role for the solving various problems in environmental regulations but they don't get along well together. There were no causal relationship between structural elements. This paper describes an emergence of new order through these interactions in environmental regulation. These environmental regulations make desperate efforts not only public sectors but also private or/and firms that make an emergence of new order with the critical point reached. Also, we provide the understanding base an environmental regulation with new order for uncertainty.

• Nuclear industry
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• v.16 no.8 s.162
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• pp.38-44
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• 1996

과학기술처는 지난 7월 기존의 $\lrcorner$원자력 관계 보고 규정$\lrcorner$을 첨삭$\cdot$보완하여 $\ulcorner$원자력 시설의 사고$\cdot$고장 발생시 보고에 관한 규정$\lrcorner$을 새로이 제정했다. 이는 그동안 원자력법령에 의하여 원자력 관계 사업자가 보고해야 할 사항이 원자력법, 원자력발전소 운영기술지침서, 방사선 비상계획서, 계량관리 및 방호규정 등에 산재되어 있어, 사업자나 규제기관 모두 혼란이 있어온 점을 해결한 것으로, 보고 대상과 보고 방법 등을 세분화하였으며, 또한 사업자에게 불합리하게 적용되는 일부 사항들을 발굴$\cdot$정리하였다.

• Proceedings of the Korea Air Pollution Research Association Conference
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• 1999.10a
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• pp.449-450
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• 1999

VOCs(volatile organic compounds)는 대기중에서 질소산화물과 함께 광화학반응에 참여하여 인체 및 동식물에 유해한 오존 등 2차 오염물질인 광화학산화물을 형성하는 전구물질로 작용한다. 1998년 8월 미국 EPA에서는 휘발성유기화합물과 지표 부근의 오존 또는 스모그의 발생량을 감소시키기 위해 페인트, 세제 및 살충제의 제조공법에 관한 새로운 규칙을 발표하여 휘발성 용제 사용 규제를 강호하고 있다(과학기술부, 1998).(중략)

• Proceedings of the Korea Air Pollution Research Association Conference
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• 1999.10a
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• pp.409-410
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• 1999

여천산업단지는 1969년 총면적 583만평 규모로 조성되어 96년 현재 96개 업체가 입주하여 연간 생산액이 13조원에 이르는 대규모 공단으로 성장하였다(한국과학기술원, 1996). 특히, 1996년 대기보전 특별대책지역으로 지정되어 엄격한 배출기준이 적용되는 지역이며, 현재 인근지역인 광양 등을 대기환경 규제지역으로 지정하고자 논의되고 있는 실정이다.(중략)

• Korean Management Science Review
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• v.3
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• pp.18-24
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• 1986

본 고에서는 불확실성을 고려한 전원개발계획방법에 대하여 간단히 소개하였다. 수요의 불확실성에 대하여 예를 들어 소개하였지만 연료비 등의 불확실성도 분석할 수가 있다. 우리는 자주 확정적 전원개발계획모형(WASP, EGEAS 등)의 결과를 최적으로 받아들인다. 그러나 그 모형의 최적계획은 계산에 사용되는 모든 자료가 반드시 미래에 그대로 나타난다는 가정하에서 만들어진 것이다. 이러한 가정을 간과하고 그 결과를 받아들인다면 커다란 오류에 빠질 것이라고 IEEE위원회는 경고하면서 불확실성을 고려한 전원개발계획 모형의 운영과 개발이 필요하다고 지적하고 있다. 한국의 전원개발계획의 환경(수요, 연료비, 건설비, 기술, 환경규제 등)은 불확실하며 이러한 불확실성에 얼마나 탄력적으로 대처하느냐가 2000년대를 향한 전원개발계획의 가장 큰 과제라 하겠다.

• 전기의세계
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• v.44 no.2
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• pp.21-27
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• 1995

인류과학 문명의 발달은 전기문명의 발전없이는 생각할 수 없음은 자명한 사실이다. 그러나 화석 에너지의 고갈로 인한 전기 에너지의 생산의 타개책으로 인간의 지혜는 원자력발전이란 귀한 에너지원을 확보하게 되었음은 실로 다행한 일이며 인간역사가 계속 이어질 수 있는 바탕을 마련하였다고 볼 수 있다. 또한, 이 원자력 에너지는 화석 에너지의 결점인 환경오염으로부터 완전해방이 되었을 뿐만 아니라 경제성 측면에서 비교우위에 있음이 확실하다. 그러나 원전은 안전성을 담보로 하기 때문에 설비의 운영관리에 많은 제약이 뒤따르고 있다. 그러므로 원전은 그 관리능력이 인정될 수 있는 국가와 국민만이 화석 에너지가 갖지 못하는 혜택을 누릴 수 있는 것이다. 그래서 원전의 안전 규제 체제는 사업자에게만 그 책임을 지울 수 없으므로 국가적인 차원에서 안전관리의 목표와 정책을 수립하고 이것을 효과적으로 시행하기 위한 법적, 제도적 장치를 마련하고 있다.