• Title/Summary/Keyword: Food Safety System

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A Study on Development of Guideline on Writing Technical Document for Electrical Medical Devices : Bone Absorptiometric X-ray System (엑스선골밀도측정기의 기술문서 작성을 위한 가이드라인 개발 연구)

  • Lee, Seung-Youl;Kim, Jae-Ryang;Kim, Eun-Rim;Lee, Jun-ho;Lee, Chang-Hyung;Park, Chang Won
    • Journal of radiological science and technology
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    • v.39 no.2
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    • pp.263-271
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    • 2016
  • The market size of the bone absorptiometric X-ray system and the number of its approval by Ministry of Food and Drug Safety (MFDS) has annually increased, with a trend of increasing aging population and osteoporosis patients. For approval of manufactured or imported medical devices in Republic of Korea, it is required to submit its technical document. Therefore, it is need to develop the technical document guideline for the bone absorptiometric X-ray system for manufacturers, importers and reviewers. First of all, the technical documents which were already approved were examined and analyzed through MFDS approval administration system. Second, safety and performance test standards and methods that match international standards were drawn after conducting survey of the market status and the technology development trend for it, with examination and analysis of applicable domestic and overseas standards. Third, by operating industry-research-government cooperation, the guideline draft on writing technical document for the bone absorptiometric X-ray system was discussed, collecting their opinion. As a result, it is suitable to international and domestic condition, includes test evaluation methods and offer various information with appropriate examples to civil petitioner, when they write the technical documents.

Study for Residue Analysis of Pinoxaden in Agricultural Commodities

  • Kim, Ji Young;Yoon, Eun Kyung;Kim, Jong Soo;Seong, Nu Ri;Yun, Sang Soon;Jung, Yong Hyun;Oh, Jae Ho;Kim, Hyochin
    • Korean Journal of Environmental Agriculture
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    • v.38 no.4
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    • pp.321-331
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    • 2019
  • BACKGROUND: Pinoxaden is the phenylpyrazoline herbicide developed by Syngenta Crop Protection, Inc. and marketed on 2006. The maximum residue levels for wheat and barley were set by import tolerance. Thus, Ministry of Food and Drug Safety (MFDS) official analytical method determining Pinoxaden residue was necessary in various food matrixes. Satisfaction of international guideline of CODEX (Codex Alimentarius Commission CAC/GL 40) and National Institute of Food and Drug Safety Evaluation-MFDS (2017) are additional pre-requirements for analytical method. In this study, liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was investigated to analyze residue of Pinoxaden (M4), which is defined as pesticide residue in Korea, in foods. METHODS AND RESULTS: Pinoxaden (M4) was extracted followed by acid digestion (2hr reflux with 1N HCl) and pH adjusting (pH 4-5 with 3% ammonium solution). To remove oil, additional clean-up step with hexane saturated with acetonitrile was required to high oil contained sample before purification. HLB cartridge and nylon syringe filter were used for purification. Then, samples were analyzed by LC-MS/MS using reserve phase column C18. Five agricultural group representative commodities (mandarin, potato, soybean, hulled rice, and red pepper) were used to verify the method in this study. The liner matrix-matched calibration curves were confirmed with coefficient of determination (r2) > 0.99 at calibration range 0.002-0.2 mg/kg. The limits of detection and quantitation were 0.004 and 0.01 mg/kg, respectively, which were suitable to apply Positive List System (PLS). Mean average accuracies of pinoxaden (M4) were shown to be 74.0-105.7%. The precision of pinoxaden and its metabolites were also shown less than 14.5% for all five samples. CONCLUSION: The method investigated in this study was suitable to CODEX (CAC/GL 40) and National Institute of Food and Drug Safety Evaluation-MFDS (2017) guideline for residue analysis. Thus, this method can be useful for determining the residue in various food matrixes in routine analysis.

Development of Simultaneous Analytical Method for Streptomycin and Dihydrostreptomycin Detection in Agricultural Products Using LC-MS/MS (LC-MS/MS를 이용한 농산물 중 Streptomycin 및 Dihydrostreptomycin 동시시험법 개발)

  • Lee, Han Sol;Do, Jung-Ah;Park, Ji-Su;Park, Shin-Min;Cho, Sung Min;Shin, Hye-Sun;Jang, Dong Eun;Choi, Young-Nae;Jung, Yong-hyun;Lee, Kangbong
    • Journal of Food Hygiene and Safety
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    • v.34 no.1
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    • pp.13-21
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    • 2019
  • A method was developed for the simultaneous detection of an antibiotic fungicide, streptomycin, and its metabolite (dihydrostreptomycin) in agricultural products using liquid chromatography-tandem mass spectrometry (LC-MS/MS). The samples were extracted using methanol adjusted to pH 3 using formic acid, and purified with a HLB (Hydrophilic lipophilic balance) cartridge. The matrix-matched calibration curves were constructed using seven concentration levels, from 0.001 to 0.1 mg/kg, and linearity of five agricultural products (hulled rice, potato, soybean, mandarin, green pepper), with coefficients of determination $(R^2){\geq}0.9906$, for streptomycin and dihydrostreptomycin. The mean recoveries at three fortification levels (LOQ, $LOQ{\times}10$, $LOQ{\times}50$, n = 5) were from 72.0~116.5% and from 72.1~116.0%, and relative standard deviations were less than 12.3% and 12.5%, respectively. The limits of quantification (LOQ) were 0.01 mg/kg, which are satisfactory for quantification levels corresponding with the Positive List System. All optimized results satisfied the criteria ranges requested in the Codex guidelines and the Food Safety Evaluation Department guidelines. The present study could serve as a reference for the establishment of maximum residue limits and be used as basic data for detection of streptomycin and dihydrostreptomycin in food.

The Analysis of Dioxin-like PCBs in Fishes and Shellfishes using Accelerated Solvent Extraction (ASE) System and Multilayer Column Chromatography (가속용매추출장치(ASE) 및 다층크로마토그래피를 이용한 어패류 중의 dioxin-like PCBs의 분석)

  • Oh, Keum-Soon;Park, Seong-Soo;Chung, So-Young;Sho, You-Sub;Kim, Jung-Soo;Jang, Seoung-Chul;Lee, Jong-Ok;Kim, Hee-Yun;Woo, Gun-Jo;Suh, Jung-Hyuck
    • Korean Journal of Food Science and Technology
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    • v.39 no.2
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    • pp.122-127
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    • 2007
  • In this study, an analytical method was optimized for detecting dioxin-like PCBs in fish and shellfish. Here, homogenized samples were extracted using an accelerated solvent extraction (ASE) system with 33 mL cell size. Multilayer column chromatography, which consisted of acidic, basic and neutral silica gels, was used for the clean up of the extracts. The instrumental analysis was executed by HRGC/HRMS to a resolution of 10,000 using 4 window multiple ion detection (MID) mode. For the results, the average recoveries ranged from 94.1 to 104.1% (${\pm}8.4$) and the limit of detection was approximately 0.1 pg/g at S/N ratio >3. Finally, the detected concentrations of dioxin-like PCBs for fish and shellfish were in the range of 0.030-1.836 pg TEQ/g.

Evaluation of Microbiological Safety of Lettuce and Cultivation Area (상추와 생산환경의 미생물 안전성 평가)

  • Kim, Se-Ri;Lee, Ji-Young;Lee, Seo-Hyun;Kim, Won-Il;Park, Kyoung-Hun;Yun, Hye-Jeong;Kim, Byeong-Suk;Chung, Duck-Hwa;Yun, Jong-Chul;Ryu, Kyoung-Yul
    • Journal of Food Hygiene and Safety
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    • v.26 no.4
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    • pp.289-295
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    • 2011
  • Produce, including leafy vegetables, has been implicated in several outbreaks of food illness. To evaluate microbiological safety of lettuce and it's cultivation area, a total of 147 samples were collected from lettuce farms and post harvest facility at Icheon, Gyeonggi province. The collected samples were assessed for presence of sanitary indicator microorganisms (Aerobic plate count, coliform count, Escherichia coli) and foodborne pathogens (Escherichia coli O157:H7, Salmonella spp., Staphylococcus aureus, Listeria monocytogenes, Bacillus cereus). The population of APC was over 4.0 log CFU from most of the samples. While the numbers of APC, and coliform of lettuce at 62 days after transplanting were 4.18 log CFU/g, and 1.00 log CFU/g, respectively, those of 10 days after transplanting were 5.37 log CFU/g, and 2.87 log CFU/g, respectively. B. cereus was highly detected from soil and balance which were contaminated with 3.5 log CFU/g, and 2.6 log CFU/100 $cm^2$, respectively. The number of E. coli recovered from gloves was 3.5 log CFU/hand. However, E. coli O157:H7, Salmonella spp., and L. monocytogenes were not detected. These data suggested that risk management system should be introduced to lettuce farms to enhance safety of lettuce.

A Simultaneously Analytical Method of Phthalate and Adipate Plasticizers in Food Packaging by Dual-Column GC-FID System (Dual-Column GC-FID System을 이용한 식품 포장재 중 Phthalate류 및 Adipate류 가소제의 동시 분석법)

  • Kang Gil-Jin;Kwak In-Shin;Eom Mi-Ok;Jeon Dea-Hoon;Kim Hyung-il;Sung Jun-Hyun;Choi Jung-Mi;Kim Eun-Kyung;Lee Young Ja
    • Journal of Food Hygiene and Safety
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    • v.20 no.4
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    • pp.277-283
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    • 2005
  • A plasticizer is a substance which is added to a material to improve its processability, flexibility and stratchability. Phthalates and adipates are the most frequently used plasticizers of poly(vinyl chloride) (PVC). However, they can migtate into food from PVC food packaging, and some of them are especially suspected as endocrine disruptors. In this study, Simultaneous analysis of 13 phthalates and 9 adipates were carried out by dual-column gas chromatography system equipped wi two FID detectors for rapid confirmation and quantification. The Proposed method was validated with > 0.993 of linearity in the ranges of 10-500 mg/l, < $3.5\%$ RSD of reproducability in 10 inter-days sample preparations, and > $98.1\%$ of recoveries for all the plasticizers. DEHA was detected in all the 3 PVC wraps at levels of 176.9-198.5mg/g. Among the 51 samples of PVC gaskets, the targeted plasticizers were detected in 41 samples. Of these plasticizer detected samples,40 contained DIDP at the levels of 157.3-374.7 mg/g and one contained DMP at the levels of 165.6 mg/g. Also, some plasticizers were detected in other packaging materials such as PET, PP, PE, Pulp. But it might be attributed to contamination in manufacturing.

Implementation of HACCP System for Safety of Donated Food in Foodbank Organization (푸드뱅크 기탁식품의 안전성 확보를 위한 HACCP 제도 적용)

  • Park, Hyun-Shin;Bae, Hyeon-Ju;Lee, Jee-Hae;Yang, Il-Sun;Kang, Hye-Seung;Kim, Chul-Jai
    • Journal of the Korean Society of Food Culture
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    • v.17 no.3
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    • pp.315-328
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    • 2002
  • The purpose of this study was to analyze the problems arising from the actual conditions of the Foodbank, and to implement the HACCP system as a solution in terms of increasing the safety of donated food within the Foodbank. In order to apply HACCP system, the entire Foodbank working process such as preparation, collection, transportation, division, and distribution was considered and analyzed to decide the application point for CCPs. Donated foods mainly consisted of processed foods, raw materials, lunch boxes, and cooked foods from mass catering establishments, which dominated over the others in terms of quantity. Cooked foods were divided into three groups based on menu-types and processing methods. Temperature, pH, and aw were measured on cooked foods, and Total Plate Count, Coliforms, E. coli, Salmonella spp., Staphylococcus aureus, Listeria monocytogenes, and E. coli O157:H7 were conducted in order to apply a HACCP plan. From these experiments, temperature, pH, and $a_w$ of donated food were likely contributed to microbial growth. Donated foods before HACCP implementation showed high numbers in terms of total plate count and Coliforms, both well over the acceptable standard levels. By setting the CCPs on maintenance of donated food below $10^{\circ}C$ and using a $75^{\circ}C$ reheating method, microbiological hazard levels were able to be controlled and lowered. From these results, it is concluded that in order to guarantee food safety, foods donated to the Foodbank must not only maintain a reasonable level of initial microbiological growth, but also must be handled properly through time and temperature controls within the Foodbank system. Furthermore, in terms of implementing the HACCP plan within the Foodbank management structure, basic food safety and sanitation measures, such as reheating facilities and various cold chain systems such as refrigerated vehicle for food transportation are importantly needed. The training and education of Foodbank personnel and management in areas such as awareness of hygiene and safe food handling and practice are also required and necessary.

Cardiovascular Safety Pharmacology of Sibutramine

  • Yun, Jaesuk;Chung, Eunyong;Choi, Ki Hwan;Cho, Dae Hyun;Song, Yun Jeong;Han, Kyoung Moon;Cha, Hey Jin;Shin, Ji Soon;Seong, Won-Keun;Kim, Young-Hoon;Kim, Hyung Soo
    • Biomolecules & Therapeutics
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    • v.23 no.4
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    • pp.386-389
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    • 2015
  • Sibutramine is an anorectic that has been banned since 2010 due to cardiovascular safety issues. However, counterfeit drugs or slimming products that include sibutramine are still available in the market. It has been reported that illegal sibutramine-contained pharmaceutical products induce cardiovascular crisis. However, the mechanism underlying sibutramine-induced cardiovascular adverse effect has not been fully evaluated yet. In this study, we performed cardiovascular safety pharmacology studies of sibutramine systemically using by hERG channel inhibition, action potential duration, and telemetry assays. Sibutramine inhibited hERG channel current of HEK293 cells with an $IC_{50}$ of $3.92{\mu}M$ in patch clamp assay and increased the heart rate and blood pressure ($76{\Delta}bpm$ in heart rate and $51{\Delta}mmHg$ in blood pressure) in beagle dogs at a dose of 30 mg/kg (per oral), while it shortened action potential duration (at $10{\mu}M$ and $30{\mu}M$, resulted in 15% and 29% decreases in $APD_{50}$, and 9% and 17% decreases in $APD_{90}$, respectively) in the Purkinje fibers of rabbits and had no effects on the QTc interval in beagle dogs. These results suggest that sibutramine has a considerable adverse effect on the cardiovascular system and may contribute to accurate drug safety regulation.