• The Korean Society of Law and Medicine
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• v.23 no.2
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• pp.119-139
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• 2022

Brain stimulation technology that administers electrical and magnetic stimulation to a brain has shown a significant level of possibility for treating a wide range of various neurological and psychiatric disorders. Depending on its nature, the technology is defined either as invasive or non-invasive, and deep brain stimulation (DBS) is one of the most well-known invasive brain stimulation technologies. Currently categorized as grade 4 medical device in accordance with Guideline On Medical Devices And Their Grades, a Notification of Ministry of Food and Drug Safety (MFDS), the DBS has been used as a stable treatment for several diseases. At the same time, the DBS technology has recently achieved substantial advancement, encouraging active discussions for its use from various perspectives. On the contrary, debates over legal regulation related to the use of DBS has relatively been smaller in numbers. In this context, this article aims to 1) introduce the DBS technology and its safety in setting out the tone; 2) touch upon major legal issues that would potentially rise from its use for four different purposes of treatment, clinical study, areas of non-standard treatment where no other methods are available, and enhancement; and finally 3) highlight disputes concerning common emerging issues observed in the aforementioned four purposes from the viewpoint of legal responsibility and liability of using the DBS, which are benefit-risk assessment, physicians' duty of information, patients' capacity to consent, control for device, and insurance coverage.

• The Korean Journal of Pesticide Science
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• v.19 no.2
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• pp.81-87
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• 2015

The present study was aimed to predict the pre-harvest residue limits (PHRLs) of pyrimethanil (fungicide) and methoxyfenozide (insecticide) in grape, and to estimate their biological half-lives and residual characteristics. The pesticides were sprayed once on grape in two different fields 10 days before harvest. At the end of 0, 1, 2, 3, 5, 7 and 10 days after application, samples were harvested for further analysis. The residual pesticides were extracted with acetonitrile and partitioned with dichloromethane, and the high-performance liquid chromatography with diode array detector (HPLC/DAD) was employed for the residue analysis. The results obtained in the present study show that the limit of detection of both pesticides were found to be $0.01mg\;kg^{-1}$. The recoveries of these pesticides were ranged between 80.6% and 102.5% with coefficient of variation lower than 10%. The biological half-lives of both pesticides were observed in field 1 and field 2 which shows 7.7 and 7.4 days for pyrimethanil and 5.1 and 6.1 days for methoxyfenozide, respectively. Further, the PHRL of pyrimethanil and methoxyfenozide was found to be $8.90mg\;kg^{-1}$ and $5.51mg\;kg^{-1}$, respectively at 10 days before harvest. Consequently, the present study suggests that the residual amounts of both pesticides will be lower than the maximum residue limits (MRLs) when grape is harvested.

• The Korea Journal of Herbology
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• v.35 no.6
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• pp.11-19
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• 2020

Objective : The genus Glycyrrhiza has been used in food and traditional herbal medicine. Glycyrrhiza new varieties Wongam and Sinwongam have been developed by Korea Rural Development Administration and investigated to register on Korean Pharmacopoeia of the Ministry of Food and Drug Safety. The aim of this study is to investigate the immunomodulatory effect of Wongam and Sinwongam comparing with listed Glycyrrhiza species (Glycyrrhiza uralensis Fischer and G. glabra Linne) for evaluations about pharmacological effect of Glycyrrhiza new varieties. Methods : We studied the immunomodulatory effect of Wongam and Sinwongam compared with G. uralensis and G. glabra using THP-1 cell in vitro model. The cells were treated with phorbol 12-myristate 13-acetate (PMA) for differentiation and stimulated with lipopolysaccharides (LPS) to induce immune activation. We analyzed and compared the effects Glycyrrhiza new varieties and listed Glycyrrhiza species using nitric oxide (NO) assay, western blot, and reverse transcription-quantitative polymerase chain reaction analysis. 1) Results : Wongam and Sinwongam showed no cytotoxicity in THP-1 cells. Wongam and Sinwongam, and listed Glycyrrhiza species increased NO production, and cyclooxygenase (COX)-2 expression with or without LPS in differentiated THP-1 macrophages. Furthermore, Wongam and Sinwongam and listed Glycyrrhiza species upregulated the mRNA expressions of T helper type 1 (Th 1)-associated cytokines in LPS-stimulated THP-1 macrophages. Conclusion : These results indicated that Wongam and Sinwongam would have effect of enhancing immune response through the increase of NO and COX-2 expression, and activate Th1-associated cytokines. The findings of this study suggest the wide applicability of Glycyrrhiza new varieties.

• Korean Journal of Environmental Agriculture
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• v.33 no.4
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• pp.290-297
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• 2014

BACKGROUND: The current study purposed to analyse the dissipation levels of a neonicotinoid insecticide and clothianidin in paddy and upland soils and clarify the effects of soil moisture on degradation and persistence of the insecticide. METHODS AND RESULTS: In order to achieve the research purposes, clothianidin 8% SG was applied to the paddy and upland fields at the rate of 0.024 kg a.i./10a, while the analytical standard was treated at 0.25 mg/kg soil under laboratory conditions. Based on the multiple first-order kinetics, total clothianidin in soils was dissipated with $DT_{50}$ of 6.7-16.1 and 6.9-8.2 days in the paddy and upland fields, respectively, whereas the figures under the laboratory condition became larger showing 56.3 and 19.6 days. CONCLUSION: As affected by soil moisture, some differences in degradative pathways were observed. Flooding of soil caused evidently demethylation and delayed cyclization of a major metabolite, thiazolylmethylguanidine (TMG) and methylaminoimidazole(MAI), compared to the aerobic upland condition. More than 80% and 50% of the parent compound was dissipated by the 24th day after the final application in both soils and, transformation products had constituted most of soil residues after that.

• The Journal of KAIRB
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• v.4 no.2
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• pp.36-41
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• 2022

Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

• Korean Journal of Veterinary Service
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• v.38 no.3
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• pp.173-180
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• 2015

Environmental pesticides used for insect control can be transferred from plants to animals even to livestock animals through food chain. Human beings also can be exposed to pesticides by consuming polluted dairy products, including meats, eggs and other milk products. Therefore, the Ministry of Food and Drug Safety (MFDS) established Standard for Pesticide Residue Limits in dairy products. The QuEChERS (quick, easy, cheap, effective, rugged and safe) methods for detecting residual pesticides are relatively well established for fruits and vegetables, however, the methods for meat have not been appropriately studied yet. In the present work, pyraclofos was used as an organophosphate pesticide to examine its tissue residue in experimental animals by QuEChERS methods. For this, pyraclofos (150 mg/kg body weight) was orally administered to male rats once a day for 2 days. After 6, 12, and 24 hr of the treatment, the tissue residues in liver and femoral muscle of the rats were determined using QuEChERS methods followed by HPLC analyses. In preliminary studies, the recovery rates of spiking samples of pyraclofos demonstrated approximately 109~110% from the tissues. In previous study, pyraclofos tissue residues were observed with significantly high levels in livers and muscles at 6 hr of oral treatment. Then, they were almost completely disappeared after 24 hr of the administration, indicating the orally exposed pyraclofos is rapidly absorbed and distributed to body organs, then quickly excreted from the body with a negligible level of tissue residue. The alterations in blood chemistry as well as the histopathology of heart, lung, liver, spleen and kidney have also been investigated in the experimental animals for assessing acute toxic effects of pyraclofos. The obtained blood chemistry indexes (ALT and AST) showed maximum peak values at 12 hr after the oral administration and decreased to the normal levels at 24 hr of the treatment. Histopathologic observation exhibited acute hepatic damages at 24 hr of the treatment. In conclusion, we suggest that QuEChERS method can be adequately optimized for the analysis of pyraclofos residues in animal tissues.

• Korean Journal of Organic Agriculture
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• v.27 no.2
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• pp.193-204
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• 2019

The aim of this study was to investigate the effect of hazard analysis and critical control point (HACCP) system application on microbial hazard management levels of pork and manufacturing environments. In this study, we compared and analyzed microbial levels in raw meat, finished products, and manufacturing environments (knifes, gloves, and cutting boards) of HACCP and non-HACCP meat markets. In addition, we surveyed the hygiene statuses of HACCP and non-HACCP meat markets. The general bacterial counts in raw meat, finished products, and manufacturing environments were lower in HACCP meat markets than in non-HACCP meat markets. Particularly, non-HACCP meat markets exceeded the Ministry of Food and Drug Safety microbiological recommendation criteria for raw meats (8.7%) and finished products (8.7%). Escherichia coli and coliform counts in raw meat, finished products, and manufacturing environments were also lower in HACCP meat markets than in non-HACCP meat markets. The biological hazard levels of finished products from non-HACCP meat markets were affected by raw meat and manufacturing environment. Moreover, according to questionnaire survey results, personal hygiene, manufacturing environment, and facility standards were lower in non-HACCP meat markets than in HACCP meat markets. Implementation of HACCP at meat markets is expected to minimize food poisoning by reducing the biological hazard levels to provide safe livestock products to consumers.

• Korean journal of applied entomology
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• v.59 no.2
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• pp.133-138
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• 2020

In 2016, the two-spotted cricket was approved as a general food ingredient by the Korean Ministry of Food and Drug Safety. Additionally, the two-spotted crickets have high protein content (60%) and can be reared throughout the year even during the overwintering period. In this study, storage conditions were set in case cricket breeding was not possible due to problems such as breeding space and labor costs, and selection oviposition mats to determine high fecundity rates and low cannibalism rates for the eggs were investigated. The oviposition mat was mostly composed of soil (p < 0.05). Less than 62 crickets per 10 litters were found to be best suited for 1 day of spawning, based on the cannibalism rate of the eggs during the egg laying period. The results from the hatched eggs indicated that the hatching extended 12 to 14 days, and the best hatching rate was approximately 85% when stored at low temperatures(16℃) for 10 days. An efficient production proposed method that established the best oviposition mat and egg storage method for the cricket.

• The Journal of Korea Institute of Information, Electronics, and Communication Technology
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• v.15 no.2
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• pp.164-177
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• 2022

Medical device usability evaluation refers to the evaluation of medical devices through actual users before the final prototype production is completed. IEC 62366, one of the international safety standards for electronic medical devices, is a standard that must be applied to obtain medical device licenses in major advanced countries such as Europe and the United States. In Korea, through the Ministry of Food and Drug Safety's notice, from January 2021, sequential application by grade has been implemented. In this study, 15 participant specialists were recruited through the Incheon G University Hospital Medical Device Convergence Center for formative evaluation during user suitability evaluation of the focused ultrasound stimulation system being developed by Icleo Co., Ltd., and the test was conducted through joint scenario development. . In the result of task performance, the performance rate was 90.67%, and after the completion of the performance, 86.67% of 'Easy user interface' and 94% of 'Identification/Readability/Understanding of information' questions in the participant survey results analysis by question. The response rate was above average.

• Journal of Life Science
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• v.27 no.6
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• pp.702-707
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• 2017

Insects and their extract have been traditionally used as medicinal resources in Asia. Recently, Gryllus bimaculatus and the larva of Tenebrio molitor, Protaetia brevitarsis, and Allomyrina dichotoma were enlisted as general food ingredients by Korean Ministry of Food and Drug Safety. As the interest in these insects is growing, the detailed investigation is needed for the standardization of suitable and safe rearing techniques. This survey was conducted via personal interviews about edible insect rearing farms in Korea. The basic feed is fermented oak sawdust for P. brevitarsis and A. dichotoma and wheat bran for T. molitor. The various feed additives are blended with each farm's own recipes. The overall growth condition, including sawdust fermentation method, feeding period, and rearing density, varies among the investigated farms. It seems that weight of last instar larva was correlated with the rearing density and duration of the larval period. The heavy metal contents were analyzed after 48 hour starvation and they were very small amount or not detected in investigated insects. We believe that the present data will contribute to develop and standardize the safe rearing techniques of edible insects in Korea.