• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.159-184
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• 2021

The significance of the enactment of the 「Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products」 is to break away from the regulation of the Pharmaceutical Affairs Act and expand patient treatment opportunities through a medical technology approach to regenerative medicine, which is essentially a medical practice called 'transplantation'. However, more than a year after the law was enacted, clinical study has not been activated, with not a single high-risk study approved by the Ministry of Food and Drug Safety being approved. The reason is that despite the legal purpose of expanding patient treatment opportunities, the data requirements for clinical study approval are set in connection with drug development despite the insufficient legal basis, making it difficult for many researchers to meet the data requirements. Prior to the enactment of the Act, submitted data for clinical study on cell therapy products within the Pharmaceutical Affairs Act were cosiderably exempted from quality and non-clinical test data, but with the enforcement of the Advanced Regenerative Bio Act, quality and non-clinical test data are required in accordance with pharmaceuticals when applying for approval of a clinical study plan. To rectify this, when considering the identity of clinical study on advanced regenerative medicine to expand treatment opportunities, recognize that there are limitations in connection with drug development. And it is necessary to preserve the identity of clinical study on advanced regenerative medicine, and on the other hand, in the case of drug product approval, clinical study results should be utilized while specifying usage requirements. Therefore, with the power of the market and the voluntary motive of the clinical researcher, it is necessary to prepare the necessary data by themselves rather than the basic requirements for clinical study approval.

• Journal of Dairy Science and Biotechnology
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• v.27 no.1
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• pp.1-12
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• 2009

In 2008, baby formula containing melamine was found to be responsible for a large outbreak of renal failure in infants in China. A total of 294,000 infants were hospitalized, and at least 6 babies died due to ingestion of the tainted formula. Melamine contains high levels of nitrogen (>60%), which is used as an indicator of protein content. Therefore, high levels of melamine in infant formula were thought to be the result of deliberate contamination m an attempt to increase its apparent protein content. Following inspections by China's national inspection agency, assorted products from at least 22 dairy manufacturers across China were found to have varied levels of melamine (range: 0.096196.61 mg/kg). Melamine co-exposure with cyanuric acid can induce acute melamine-cyanurate crystal nephropathy, which can lead to renal failure at much lower doses than if either compound were ingested alone. However, currently, there are very few data on melamine analogues other than cyanuric acid. At an expert meeting of the WHO and FAO held to review toxicological aspects of melamine and cyanuric acid on December 14, 2008, a new tolerable daily intake (TDI) of melamine was established that could be applied to the entire population, including infants. Therefore, a risk assessment of the various theoretical melamine contamination levels in infant formula and selected representative foods (other than infant formula and sole-source nutrition products) is urgently needed for Korean babies and children up to 7 years of age. Although the undetectable level regulation for infant formula may be low enough to guarantee the safety of babies under the age of 1 year (including premature babies), the melamine standard of 2.5 ppm for foods other than baby formula could be insufficient to protect the 95th percentile population aged 1~2 years because of this demographic's high consumption of milk, yogurt, and soy milk (hazard index = 1.79). Because TDIs are chronic values intended to protect an individual over his/her lifetime, occasional modest ingestion in excess of the TDI is not likely to be a health concern. However, children aged 1~2 years may have renal systems that are comparatively more sensitive to the crystallization of melamine and its analogues. Therefore, governmental jurisdictions may need to practice more prudent management of food items that could raise the melamine exposure for this population.

• Journal of Food Hygiene and Safety
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• v.26 no.3
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• pp.273-282
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• 2011

This study established hazards which may cause risk to human at farm during cultivation stage of paprika. Samples of plants (paprika, leaf, stem), cultivation environments (water, soil), personal hygiene (hand, glove, clothes), work utensils (carpet, basket, box) and airborne bacteria were collected from three paprika farms (A, B, C) located in Western Gyeongnam, Korea. The collected samples were assessed for biological (sanitary indications and major foodborne pathogens), chemical (heavy metals, pesticide residues) and physical hazards. In biological hazards, total bacteria and coliform were detected at the levels of 1.9~6.6 and 0.0~4.610g CFU/g, leaf, mL, hand or 100 $cm^2$, while Escherichia coli was not detected in all samples. In major pathogens, only Bacillus cereus were detected at levels of ${\leq}$ 1.5 log CFU/g, mL, hand or 100 $cm^2$, while Staphylococuus aureus, Listeria monocytogenes, E. coli O157 and Salmonella spp. were not detected in all samples. Heavy metal and pesticide residue as chemical hazards were detected at levels below the regulation limit, physical hazard factors, such as insects, pieces of metal and glasses, were also found in paprika farms. Proper management is needed to prevent biological hazards due to cross-contamination while physical and chemical hazards were appropriate GAP criteria.

• Journal of Life Science
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• v.20 no.5
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• pp.717-722
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• 2010

The safety of animal feed was evaluated by analyzing the levels of heavy metals (Pb, Cr, Cd, As, Se and Ag) in cattle, swine, and poultry feeds and the levels of Cu, Zn and P in swine feed. Feeds used in the analysis were produced in Korea from 2004 through the first half of 2007. The results of the study revealed that, with the exception of Cd, the concentration of heavy metals were much lower than the Minimum Regulation Levels (MRLs). However, the Cd concentration exceeded the MRL in 1 of 987 swine feed samples in 2005, as well as in 4 of 1,239 swine feed samples and 1 of 778 poultry feed samples in 2006. The levels of Cu, Zn and P in swine feed were compared with the swine breeding standard. The results of this analysis revealed that the Cu concentrations in the samples exceeded the MRL for growing pigs by 0.97%, and that for finishing and breeding pigs by 9.9%. In addition, the Cu levels (80.98 ppm for piglet, 44.82 ppm for growing pigs, 19 ppm for finishing and breeding pigs) in swine feed showed higher levels compared to 3.5-6.0 ppm, which is the Cu requirement for swine. Furthermore, the results of the Zn analysis revealed that the samples exceeded the MRL for piglets, growing pigs, and finishing and breeding pigs by 5.7%, 7.7%, and 9.3%, respectively. Finally, the average concentration of P in swine feed was 0.74%, which is almost the same as the phosphate requirement for swine.

• Journal of Food Hygiene and Safety
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• v.34 no.2
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• pp.183-190
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• 2019

Ursolic acid is recognized for various effects such as anti-cancer, antioxidant, and anti-inflammatory activity. In this study, we confirmed the anti-cancer effect of ursolic acid on human melanoma cancer cells, A375SM and A375P. Survival rate of the melanoma cells was confirmed by MTT assay and the proliferation rate was confirmed by wound healing assay. The rate of apoptotic bodies was confirmed by DAPI staining, and apoptosis rate was confirmed by flow cytometry. The induction of apoptosis protein was examined by western blotting according to the concentration of ursolic acid in melanoma cells. The survival and proliferation rates of melanoma cells were decreased according to the treatment concentrations of ursolic acid. DAPI staining showed that chromosomal condensation of melanoma cells was increased with increasing concentrations of ursolic acid, and increased apoptosis rate of melanoma cells by ursolic acid was confirmed by flow cytometry. We also confirmed by western blotting that cleaved-PARP and Bax were increased and Bcl-2 was decreased at $12{\mu}M$ concentration of uricolic acid in melanoma cells. This study was carried out at low concentrations of ursolic acid, 0 to $20{\mu}M$, and analyzed 24 h after treatment. As a result of this study, it is thought that ursolic acid has the anti-cancer effect through the regulation of apoptosis-related proteins in melanoma cells A375SM and A375P.

• Journal of Life Science
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• v.25 no.9
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• pp.1036-1042
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• 2015

By using effective sanitizers, early block for transmission of pathogens is the effective way to prevent epidermic outbreaks. Here we developed a chlorine oxide bubbling type of sanitizing tablets and evaluated the disinfectant and sanitization effects. The sanitizers showed 99.999% of sanitization effect for Escherichia coli ATCC 10536 and Staphylococcus aureus ATCC 6538 strains for 5 min±10 sec on 20±1℃ in clean condition by dilution-neutralization method. It reduced more than 5 log₁₀ cfu/ml of a legal permission standard of colony reduction. When a few used socks and underwear soaked for one hour in the 0.1% of the sanitizing tablets, no microorganisms were grown on CHROMagar plates. However, on CHROMagar plates of the no sanitizing tablets treated control, about 6.5×10⁴ cfu/ml of Staphylococcus sp., Klebsiella sp. and Enterococus sp. were grown. Furthermore, the sanitizing tablets killed approximately 1.5x10⁸ cfu/ml of E. coli BL21 in 5 minutes. Therefore, we concluded that the chlorine based bubbling type of sanitizing tablets satisfied the legal standard for the regulation of food and drug safety for disinfectants and sanitizers to pathogens and daily supplies.

• Journal of Distribution Science
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• v.13 no.2
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• pp.95-104
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• 2015

Purpose - This is a comparative study of the market development and characteristics of Ulsan in South Korea, Fukuoka in Japan, and Yanji in China, which are major East Sea Rim cities with adjacent areas of similar natural characteristics of the sea and the country. Particularly, it considers these aspects while focusing on the evolution of networks that appear in the distribution system and at the same time examining the institutions of market activation and regulations that are handled by the central and the local government and the changing logistics due to the development of transportation and the concern of food safety, using a meso-analysis approach. Research design, data, and methodology - The study used a historical and comparative approach with a focus on case studies. It made use of various materials such as local newspaper articles, reports, literature, interviews with experts, discussions with local merchants, discussions with customers, and so forth. Results - In the case of Fukuoka, from the 1960s, due to the entry of supermarkets, supermarkets expanded and they have now come to a dominant market position in the current market. They offer a convenient and comfortable environment while providing a large mall offering a variety of educational and cultural activities for customers to meet the customers' needs, such as the preferences of Korean tourists, who appear to prefer Japanese foods. The Fukuoka City Central Wholesale Market has been exporting fruits and vegetables as well as seafood products to Korea, China, and so forth. In the case of Ulsan, as in the early 2000s, due to the expansion of supermarkets, the traditional markets have been shrinking and further, the modernization of traditional markets was conducted under the auspices of the Small Business Administration. In addition to the large discount malls, the expansion of SSM is expected to further drive the small trader bay. Shopping malls, department stores, and traditional markets contend with each other in Yanji, China, but a large number of citizens appear to prefer traditional markets and imported milk in the supermarket after the melamine scandal in China. Recently, the WanYuan (萬源) wholesale market has been partially completed and made an attempt to become a logistics hub in Northeast Asia. Conclusions - For the development of Korea's retail industry, it is important to offer the government with proposals regarding desired regulation. On the other hand, in order to enable the business of traditional markets, it requires an association for cultural tourism. At present, it would be better to provide a venture fund for the youth rather than infrastructure support. This study emphasizes the importance of institutions and policy to develop networks in the East Sea Rim. Future studies should conduct a survey on customers, managers, and merchants more carefully and systematically to understand the market situation while considering the size of the city and its evolution of markets, as well as policies and institutions.

• Korean Journal of Fisheries and Aquatic Sciences
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• v.32 no.3
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• pp.256-260
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• 1999

Minimun-detectable levels to 28 antibacterial agents used for the prevention and the treatment of fish diseases were determined to establish optimal detective method of bioassay in fish by the EEC 4-plate method, the modified method of EEC 4-plate and the standard method of analysis in food safety regulation. The test organisms used in the methods of bioassay were as follows: Bacillus subtilis BGA (B. subtilis) and Micrococcus luteus ATCC 9341 (M. luteus) in the EEC 4-plate method, B. subtilis, M. luteus and Bacillus cereus var. mycoides ATCC 11778 (B. cereus) in the modified of EEC 4-plate, and B. subtilis, M. luteus, B. cereus and Bacillus stearothermophilis var. calidolactis C-953 (B. stearothermophilis) in the standard method. The standard method showed predominant sensitivity in the detection of penicillins (PCs), and was also highly sensitive to aminoglycosides (AGs). The sensitivity of standard method in the detection of tetracyclines (TCs), marrolides (MLs), nitrofuran derivatives(NFs) and quinolones (QNs) was very low, and against sulfonamides (SAs), however, was extremely low. The modified method of EEC 4-plate showed very high sensitivity to TCs. Both the EEC 4-plate and the modified method of EEC 4-plate showed competitively high sensitivity in the detection of PCs, MLs, NFs, QNs and SAs. All the methods studied in the experiment showed very low sensitivity against chloramphenicol (CMs). Consequently, the modified method of EEC 4-Plate was the best bioassay method with a wide range of sensitivity for the optimal detection of the residual antibacterial agents in fish.

• Journal of Pharmacopuncture
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• v.18 no.1
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• pp.56-62
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• 2015

Objectives: The purpose of the study is to assess both the approximate lethal dose and the single dose intramuscular injection toxicity of Danggui (Angelica gigantis radix) pharmacopuncture (DGP) in Sprague-Dawley (SD) rats. Methods: The experiments were conducted at the good laboratory practice (GLP) laboratory, Biotoxtech Co., which is a laboratory approved by the ministry of food and drug safety (MFDS). The study was performed according to the GLP regulation and the toxicity test guidelines of the MFDS (2009) after approval of the institutional animal care and use committee of Biotoxtech. Single doses of DGP were injected intramuscularly into the rats in three test groups of 6 week old SD rats (5 male and 5 female rats per groups) in the amounts of 0.1, 0.5, and 1.0 mL/animal for groups 2, 3, and 4, respectively, and normal saline solution in the amount of 1.0 mL/animal was injected intramuscularly into the rats (5 male and 5 female rats) in the control group. Observations of the general symptoms and weight measurements were performed during the 14 day observation period after the injection. Hematologic and serum biochemical examination, necropsy, and a local tolerance test at the injection site were done after the observation period. Results: No death was observed in three test groups (0.1, 0.5 and 1.0 mL/animal group). In addition, the injection of DGP had no effect on general symptoms, weights, hematologic and serum biochemical examination, and necropsy. The results from the local tolerance tests at injection site showed no treatment related effects in the SD rats. Conclusion: The results of single dose intramuscular injection of DGP suggest that the approximate lethal dose is above 1.0 mL/animal for both male and female SD rats and that intramuscular injection of DGP may be safe.

• Journal of Food Hygiene and Safety
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• v.27 no.1
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• pp.42-49
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• 2012

This study was carried out to investigate the toxicity of food Red No.2 in the Sprague-Dawley (SD) female rat for 4 weeks. SD rats were orally administered for 28 days, with dosage of 500, 1,000, 2,000 mg/kg/day. Animals treated with food Red No.2 did not cause any death and show any clinical signs. They did not show any significant changes of body weight, feed uptake and water consumption. There were not significantly different from the control group in urinalysis, hematological, serum biochemical value and histopathological examination. In conclusion, 4 weeks of the repetitive oral medication of food Red No.2 has resulted no alteration of toxicity according to the test materials in the group of female rats with injection of 2,000 mg/kg. Therefore, food Red No.2 was not indicated to have any toxic effect in the SD rats, when it was orally administered below the dosage 2,000 mg/kg/day for 4 weeks.