• Journal of Radiation Protection and Research
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• v.43 no.3
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• pp.124-129
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• 2018

Background: Effluent Concentration Limits (ECLs) were re-evaluated via direct calculation using dose coefficients based on radiation protection quantity introduced in Korea and the intrinsic breathing rates of Korean residents. Materials and Methods: The re-evaluated ECLs were compared with the domestic standards given in the Notice of the Nuclear Safety and Security Commission (NSSC), as well as with ECLs specified in the Code of Federal Regulations (CFR). Results and Discussion: The relative ratios of the re-evaluated ECLs to the currently applied domestic standards differed depending on the radionuclide type, but it was clearly shown that, for tritium ($^3H$) and radiocarbon ($^{14}C$), which significantly affect radiological dose to the public during the normal operation of nuclear power plants, the re-evaluated ECLs were higher than the domestic standards. This implies that Korean standards are relatively conservative. Conclusion: The re-evaluated results for each age group showed that $^{131}I$ (radioiodine), one of the significant radionuclides, had the lowest values, but nonetheless, the domestic standards for radioiodine were lower than the ECLs given in the CFR and the re-evaluated ECLs via a method given in the CFR.

• The Korean Journal of Air & Space Law and Policy
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• v.29 no.2
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• pp.183-204
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• 2014

US 911 incidents have changed all aviation security system in the world. Especially the US changed all existing system into new one. One of the most fundamental changes is aviation security acts, regulation and several programmes. Based on the new aviation security act enacted in 2001, several code of federal regulations have been amended to strengthen US aviation security system. These regulation also enable new aviation security programmes including several airline and airport security related programmes, K-9 programme, BDO programme and air marshall programmed. All the programmes enables US aviation security improvements. Also the creating of TSA based on the aviation and transportation security act has provided the enhancement of aviation security in US. The purpose of this thesis is studying the change of aviation security system in the US especiatly in terms of aviation security legislation perfective and comparing the system with Korean aviation security legal system and provides possible solution to enhance Korean aviation security legislation and structure.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.73-79
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• 2023

The purpose of this study is to derive medical devices with different management systems through comparison of domestic and overseas medical device product classification systems and to propose management conversion measures for the products. The definitions of medical devices were compared and the scope of medical devices defined by each country was confirmed through surveys of the Medical Device Act, Federal Food, Drug & Cosmetics Act (FD&C) in the U.S., and Medical Device Regulations (MDR) in Europe. Using the Ministry of Food and Drug Safety's regulations on medical device products and grades, 21 CFR part 860-892 and product code classification files in U.S., and EMDN in Europe as basic data to compare medical device products and derive medical devices with different management systems. As a result of comparing the definition and product classification systems of medical devices in Korea, the U.S. and Europe, medical device accessories, prosthetic limbs and aids among assistive devices for persons with disabilities, drugs, quasi-drugs and industrial products that are not managed by medical devices in Korea are managed as medical devices in the U.S. and Europe. This study aims to improve public health by securing systematic product safety management and essential performance under medical device regulations. Management within a single medical device system will increase the efficiency of licensing work of domestic medical device manufacturers and related organizations. It is also expected to help advance the system according to the international harmony of the item classification system and enhance smooth import and export competitiveness.

• Fire Science and Engineering
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• v.30 no.4
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• pp.20-26
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• 2016

When the fire takes place in Nuclear Powr Plants(NPPs), the reactor should achieve and maintain safe shut-down conditions and minimize the radioactive material released to the environment. The U.S. Nuclear Regulatory Commission (NRC) has issued numerous generic communications related to fire protection over the past 20 years, after it issued its requirements in the Fire Protection Rule set forth in Title 10, Section 50.48 of the Code of Federal Regulations (10 CFR 50.48) and Appendix R to the 10 CFR 50. The and Nuclear Energy Institute (NEI) has developed a Methodology for Risk Informed Fire Safe-Shutdown Analysis, which is related to the Deterministic Method for Multiple Spurious Operations solutions. The aim of this study was to identify, achieve, and maintain Post-Fire Safe-Shutdown of the Main Control Room (MCR) of the CANDU reactor, even though one train of the multiple Safety Structures, Systems, and Components (SCCs) fail by the technical specification and analysis method.

• Bulletin of Food Technology
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• v.15 no.2
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• pp.93-99
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• 2002

고압처리로 멸균된(high-pressure- sterilized) 저산성 식품은 아직 본격적으로 시장에 나오지는 않고 있다. 그러나 고압처리로 살균시켜(high-pressure-pasteurized) 제품의 부가가치를 높인 상품들은 일부 시판되고 있다. 미국시장에는 구아카몰(guacamole),굴 등이 있고, 일본과 유럽에는 잼, 젤리, 생선제품, 육제품, 슬라이스 햄, 샐러드 드레싱, 쌀떡, 주스, 요구르트 등이 판매되고 있다. 기술이 발전되어 처리비용이 떨어짐에따라 우유나 오렌지 주스 같은 저부가가치의 제품(high-volume commodity products)에도 고압처리 기술이 적용되는 예를 보게 될 것이다.미국 FDA의 "열처리된 저산성식품은 용접밀봉된 용기(캔, hermetically sealed container)에 포장되어야 한다." 는 규정(Title 21, Part 113 of the Code Federal Regulations)은 고압처리 식품을 염두에 두고 만들어진 규정은 아니지만, 저산성식품의 고압처리 공정(high-pressure processing)은 강력한 살균력을 제공하고 있다. 따라서 위의 FDA 규정(21 CFR 113)의 모든 조항은 고압처리 저산성 식품이 상업적인 생산에 들어가기 전에 시행되어야만 하는 것이다. 그 규정의 주요 조항중의 하나는 고압처리 공정에 대한 전문적인 지식을 가진 전문가나 위원회 등에 의하여 세부적인 고압처리공정 절차를 확립하는 것이다. 공정의 전문가들은 안전성을 증명하기 위해서 적합한 과학적인 방법을 사용하여 고압처리 공정을 확립해야만 한다. 저산성 식품에 대한 고압처리 공정은 주의깊게 설정된 공정조건하에서 재현성 있게 안전한 식품을 생산할 수 있어야 한다. 살균에 대한 안전성과 재현성이 입증되면 고압에 의한 살균처리공정 설계는 일반적인 대량생산 공정으로 활용될 수 있게 된다. PP(고압처리공정)의 유효성이 보다 확실하게 입증되고 널리 활용되려면, 공정의 살균력과 일관성(uniformity)을 증명하는 미생물적, 물리적, 화학적, 공학적인 여러 분야가 통합된 검증방법이 필요하다. 전통적인 열처리 공정은 스팀열의 가열시간으로 설명이 충분하다. 물론 HPP살균에서도 시간과 온도는 주요 변수이지만, 압력에 의한 미생물살균도 고려되어야만 한다. 또한 점도, 밀도, 구성성분, pH, 수분활성도 같은 해당제품의 특성도 제품의 고압처리 살균공정, 특히 미생물의 사멸에 영향을 미칠 수도 있다.

• Proceedings of the Korean Environmental Sciences Society Conference
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• 1998.10a
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• pp.2-4
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• 1998

Proliferation of Nocardia amarae cells in activated sludge has often been associated with the generation of nuisance foams. Despite intense research activities in recent years to examine the causes and control of Nocardia foaming in activated sludge, the foaming continued to persist throughout the activated sludge treatment plants in United States. In addition to causing various operational problems to treatment processes, the presence of Nocardia may have secondary effects on the fate of heavy metals that are not well known. For example, for treatment plants facing more stringent metal removal requirements, potential metal removal by Nocardia cells in foaming activated sludge would be a welcome secondary effect. In contrast, with new viosolid disposal regulations in place (Code o( Federal Regulation No. 503), higher concentration of metals in biosolids from foaming activated sludge could create management problems. The goal of this research was to investigate the metal sorption property of Nocardia amarae cells grown in batch reactors and in chemostat reactors. Specific surface area and metal sorption characteristics of N. amarae cells harvested at various growth stages were compared. Three metals examined in this study were copper, cadmium and nickel. Nocardia amarae strain (SRWTP isolate) used in this study was obtained from the University of California at Berkeley. The pure culture was grown in 4L batch reactor containing mineral salt medium with sodium acetate as the sole carbon source. In order to quantify the sorption of heavy metal ions to N amarae cell surfaces, cells from the batch reactor were harvested, washed, and suspended in 30mL centrifuge tubes. Metal sorption studies were conducted at pH 7.0 and ionlc strength of 10-2M. The sorption Isotherm showed that the cells harvested from the stationary and endogenous growth phase exhibited significantly higher metal sorption capacity than the cells from the exponential phase. The sequence of preferential uptake of metals by N. amarae cells was Cu>Cd>Ni. The specific surFace area of Nocardia cells was determined by a dye adsorption method. N.amarae cells growing at ewponential phase had significantly less specific surface area than that of stationary phase, indicating that the lower metal sorption capacity of Nocardia cells growing at exponential phase may be due to the lower specific surface area. The growth conditions of Nocardia cells in continuous culture affect their cell surface properties, thereby governing the adsorption capacity of heavy metal. The comparison of dye sorption isotherms for Nocardia cells growing at various growth rates revealed that the cell surface area increased with increasing sludge age, indicating that the cell surface area is highly dependent on the steady-state growth rate. The highest specific surface area of 199m21g was obtained from N.amarae cell harvested at 0.33 day-1 of growth rate. This result suggests that growth condition not only alters the structure of Nocardia cell wall but also affects the surface area, thus yielding more binding sites of metal removal. After reaching the steady-state condition at dilution rate, metal adsorption isotherms were used to determine the equilibrium distributions of metals between aqueous and Nocardia cell surfaces. The metal sorption capacity of Nocardia biomass harvested from 0.33 day-1 of growth rate was significantly higher than that of cells harvested from 0.5- and 1-day-1 operation, indicatng that N.amarae cells with a lower growth rate have higher sorpion capacity. This result was in close agreement with the trend observed from the batch study. To evaluate the effect of Nocardia cells on the metal binding capacity of activated sludge, specific surface area and metal sorption capacity of the mixture of Nocardia pure cultures and activated sludge biomass were determined by a series of batch experiments. The higher levels of Nocardia cells in the Nocardia-activated sludge samples resulted in the higher specific surface area, explaining the higher metal sorption sites by the mixed luquor samples containing greater amounts on Nocardia cells. The effect of Nocardia cells on the metal sorption capacity of activated sludge was evaluated by spiking an activated sludge sample with various amounts of pre culture Nocardia cells. The results of the Langmuir isotherm model fitted to the metal sorption by various mixtures of Nocardia and activated sludge indicated that the mixture containing higher Nocardia levels had higher metal adsorption capacity than the mixture containing lower Nocardia levels. At Nocardia levels above 100mg/g VSS, the metal sorption capacity of activate sludge increased proportionally with the amount of Noeardia cells present in the mixed liquor, indicating that the presence of Nocardia may increase the viosorption capacity of activated sludge.

• Korea Trade Review
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• v.48 no.3
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• pp.131-150
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• 2023

The purpose of this study was to find a countermeasure to the U.S. import refusals for the Korean healthcare and life sciences industry. To this end, an analysis of trends during the pandemic was conducted using the KITA Border Rejection Database, which includes information on items and types of import refusals. The reason for rejection was also analyzed according to the FDA violation codes. The degree of countermeasure for import refusals was identified by measuring the unit rejection rate (URR). The results of the analysis showed that the major U.S. import refusals for the Korean healthcare and life sciences industry had expanded from contact lenses to COVID-19 diagnostic kits and drugs after the pandemic broke out. The major reasons for import refusals were non-compliance with the Predicate Device and Drugs Act and non-approval by the FDA for products and facilities. On the other hand, the unit rejection rate (URR) of major items in the Korean healthcare and life sciences industry was measured higher than the industry average. The results therefore showed a low level of response to U.S. import refusals. The results of the analysis of reasons for import refusals by item according to FDA violation codes were as follows. First of all, the main violation for contact lenses and COVID-19 diagnostic kits corresponded to misbranding. This was often due to the fact that Korean companies did not provide the relevant notices and information required by the FDA. Many cases also failed to demonstrate a substantial equivalency compared to predicate devices already on the market. On the other hand, applications for new unapproved drugs were not accepted as they had yet to pass relevant regulations that would prove their safety and efficacy. In conclusion, import refusals for the Korean healthcare and life sciences industry were found to be closely related to technical barriers to trade (TBT).