• Title/Summary/Keyword: MFDS

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Laboratory Diagnosis of Coronavirus Disease 19 (COVID-19) in Korea: Current Status, Limitation, and Challenges (국내 중증 급성 호흡기 증후군 코로나 바이러스의 검사실 내 진단: 현재, 한계점 그리고 직면한 과제)

  • Song, Gi Seon;Lee, You-Rim;Kim, Sungmin;Kim, Wontae;Choi, Jungwon;Yoo, Dahyeon;Yoo, Jungyoung;Jang, Kyung-Tae;Lee, Jaewang;Jun, Jin Hyun
    • Korean Journal of Clinical Laboratory Science
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    • v.52 no.3
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    • pp.284-295
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    • 2020
  • In December 2019, the first coronavirus disease- 2019 (COVID-19) patient was reported in Wuhan, Hubei Province, China. Since then, the number of patients who suffered severe acute respiratory syndrome caused by the novel Coronavirus (SARS-CoV-2 or 2019-nCoV) has increased dramatically in Korea. This new variant virus induces pulmonary diseases, including cough, sore throat, rhinorrhea, dyspnea, and pneumonia. Because SARS-CoV-2 is an RNA virus, real-time reverse-transcriptase PCR has been used widely to diagnose COVID-19. As the Korea Centers for Disease Prevention and Control (KCDC) and Ministry of Food & Drug Safety (MFDS) approved emergency use authorization, clinical specimens collected from COVID-19 patients and even healthy people have been clinically diagnosed by laboratory medicine. Based on a literature search, this paper reviews the epidemiology, symptoms, molecular diagnostics approved by KCDC, a current diagnosis of COVID-19 in the laboratories, the difference between molecular and serological diagnosis, and guidelines for clinical specimens. In addition, the Korean guidelines of biosafety for clinical laboratory scientists are evaluated to prevent healthcare-associated infection. The author's experience and lessons as clinical laboratory scientists will provide valuable insights to protect the domestic and international health community in this COVID-19 pandemic around the world.

Establishment of Microbial Criteria by Investigation of Microbial Contamination in Ready-to-Eat Foods (즉석섭취·편의식품류의 미생물 오염도 조사를 통한 기준·규격 재평가)

  • Song, Bo Ra;Kim, Soon Han;Kim, Jin-Kwang;Han, Jeong-A;Kwak, Hyo Sun;Chung, Kyung-Tae;Heo, Eun Jeong
    • Journal of Food Hygiene and Safety
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    • v.32 no.5
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    • pp.348-354
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    • 2017
  • Internationally different food safety regulation and standards could cause troubles in trade unless those are built on scientific knowledge. In this research, we monitored the microbial population and analyzed the results to determine the level of microbial contamination in foodstuffs using relatively new statistical analysis (microbiological sampling plan, International Commission on Microbiological Specification for Foods). The goal of this research falls on establishing entirely new standards for various food categories addressed in the Korean "Food Code". Targets for monitoring were indicator organisms (i.e. total aerobic count, coliform and Escherichia coli) and foodborne pathogens (i.e. Bacillus cereus, Staphylococcus aureus and Clostridium perfringens) in ready-to-eat (RTE) products. As the result of the monitoring, total aerobic count, coliform, E. coli, and B. cereus in RTE products were found at the mean values of 2.10 log CFU/g, -0.60 log CFU/g, -1.33 log CFU/g and -1.23 log CFU/g, respectively. S. aureus was detected with the level of -1.35 log CFU/g only in fresh-cut food, while C. perfringens was -1.37 log CFU/g only in ready-to-cook food. Other samples did not have any food borne pathogens. Total aerobic count, B. cereus, S. aureus and C. perfringens satisfied the Food Code (the MFDS). On the basis of the analysis, we proposed a draft of microbial criteria for RTE products.

Development and Validation of an Analytical Method for Determination of Fungicide Benzovindiflupyr in Agricultural Commodities Using LC-MS/MS (LC-MS/MS를 이용한 농산물 중 살균제 벤조빈디플루피르의 잔류시험법 개발 및 검증)

  • Lim, Seung-Hee;Do, Jung-Ah;Park, Shin-Min;Pak, Won-Min;Yoon, Ji Hye;Kim, Ji Young;Chang, Moon-Ik
    • Journal of Food Hygiene and Safety
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    • v.32 no.4
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    • pp.298-305
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    • 2017
  • Benzovindiflupyr is a new pyrazole carboxamide fungicide that inhibits succinate dehydrogenase of mitochondrial respiratory chain. This study was carried out to develop an analytical method for the determination of benzovindiflupyr residues in agricultural commodities using LC-MS/MS. The benzovindiflupyr residues in samples were extracted by using acetonitrile, partitioned with dichloromethane, and then purified with silica solid phase extraction (SPE) cartridge. Correlation coefficient ($r^2$) of benzovindiflupyr standard solution was 0.99 over the calibration ranges ($0.001{\sim}0.5{\mu}g/mL$). Recovery tests were conducted on 5 representative agricultural commodities (mandarin, green pepper, potato, soybean, and hulled rice) to validate the analytical method. The recoveries ranged from 79.3% to 110.0% and then relative standard deviation (RSD) was less than 9.1%. Also the limit of detection (LOD) and limit of quantification (LOQ) were 0.0005 and 0.005 mg/kg, respectively. The recoveries of interlaboratory validation ranged from 83.4% to 117.3% and the coefficient of variation (CV) was 9.0%. All results were followed with Codex guideline (CAC/GL 40) and Ministry of Food and Safety guideline (MFDS, 2016). The proposed new analytical method proved to be accurate, effective, and sensitive for benzovindiflupyr determination and would be used as an official analytical method.

A Study on Heavy Metal Concentrations of Oxidized Hair Coloring Products in Korea Market (한국에서 유통 중인 산화형 염모제의 중금속 농도에 관한 연구)

  • Choi, Chae Man;Hong, Mi Sun;Lee, Yun Jung;Kim, Hwa Soon;Kim, Hyun Jung;Kim, Jung Hun;Chae, Young Zoo
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.39 no.3
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    • pp.241-249
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    • 2013
  • This study was aimed to provide the fundamental data about oxidized hair color products. For this reason, we collected 125 oxidized hair color products, which were distributed in domestic market from January to October, 2012, and measured the heavy metal concentrations of lead, arsenic, cadmium, chromium, manganese, nickel, copper in the samples. Results were compared by domestic, foreign, henna, type and color. The average metal concentrations were as follows; 0.211 ${\mu}g/g$ for lead, 0.008 ${\mu}g/g$ for cadmium, 0.051 ${\mu}g/g$ for arsenic, 0.954 ${\mu}g/g$ for chromium, 6.250 ${\mu}g/g$ for manganese, 0.591 ${\mu}g/g$ for nickel and 0.544 ${\mu}g/g$ for copper. In case of lead and arsenic, the concentrations were much less than the regulated amount (20 ${\mu}g/g$ and 10 ${\mu}g/g$, respectively) suggested by MFDS (Ministry of Food and Drug Safety). In henna (p < 0.05), the concentrations were significantly higher than those of other domestic and foreign oxidized hair color products as follows; 1.264 ${\mu}g/g$ for lead, 0.267 ${\mu}g/g$ for arsenic, 0.025 ${\mu}g/g$ for cadmium, 4.055 ${\mu}g/g$ for chromium, 72.044 ${\mu}g/g$ for manganese, 3.076 ${\mu}g/g$ for nickel and 4.640 ${\mu}g/g$ for copper. Statistically, it showed that the heavy metal concentrations were quite different for the different types of hair color products. The cream and liquid type products had the highest average concentration in chromium (0.708 ${\mu}g/g$, 0.478 ${\mu}g/g$, respectively). On the other hand, powder type products showed the highest concentration in manganese (60.041 ${\mu}g/g$). In addition, the concentrations of heavy metals and the color of products are not quite correlated. It was shown that average concentrations of lead and chromium were higher for yellow, chromium for red and pink, manganese for brown and black, and nickel for green.

A Study on Migration of Heavy Metals from Kitchen Utensils Including Glassware, Ceramics, Enamel, Earthenware and Plastics (유리제 등 조리기구 중 중금속 이행에 관한 연구)

  • Choi, Jae-Chon;Park, Se-Jong;Goh, Hyeah;Lee, Ju Yeun;Eom, Mi Ok;Kim, Meehye
    • Journal of Food Hygiene and Safety
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    • v.29 no.4
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    • pp.334-339
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    • 2014
  • The purpose of our study was to investigate the migration level of lead (Pb), cadmium (Cd), antimony (Sb), arsenic (As), hexavalent chromium ($Cr^{6+}$) and mercury (Hg) from cookwares into food simulants and to evaluate the safety of each heavy metals. The test articles for heavy metals were glassware, ceramics, enamel, earthenware, polypropylene and polyethylene cookwares for Pb and Cd, enamel for Sb, earthenware for As, polyethylene and polypropylene cookwares for $Cr^{6+}$ and Hg. All the article samples of 391 intended for contact with foods were purchased in domestic markets. Pb, Cd, Sb and As were analyzed by Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES), $Cr^{6+}$ by UV visible spectrophotometer and Hg by mercury analyzer. The migration levels of heavy metals in all the samples were within the migration limits of Ministry of Food and Drug Safety (MFDS). As a result of safety evaluation, our results showed that the estimated daily intakes (EDI, mg/kg bw/day) were $9.12{\times}10^{-6}$ and $8.83{\times}10^{-7}$ for Pb and Cd from ceramics and $1.19{\times}10^{-5}$, $1.23{\times}10^{-5}$ and $7.52{\times}10^{-6}$ for Pb, Cd and Sb from enamel. Tolerable daily intakes (TDI, mg/kg bw/day) were established respectively as 0.0036, 0.00081, 0.0021, and 0.0006 for Pb, Cd, As and Hg by JECFA (Joint FAO/WHO Expert Committee on Food Additives), as 0.0060 for Sb by WHO (World Health Organization). When comparing with TDIs, the EDIs accounted for 0.25% and 0.11% for Pb and Cd from ceramics and 0.33%, 1.52% and 0.13% for Pb, Cd and Sb from enamel.

Analytical Method Development for Determination of Silymarin by LC-MS/MS for Related Health Functional Foods (LC-MS/MS를 이용한 건강기능식품 중 실리마린 분석법 연구)

  • Oh, Mihyune;Lee, Jin Hee;Kim, Sang-A;Kim, Meehye
    • Journal of Food Hygiene and Safety
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    • v.33 no.2
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    • pp.124-130
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    • 2018
  • The Ministry of Food and Drug Safety (MFDS) is amending its test methods for the use of health functional foods (dietary food supplement), in order to establish regulatory standards and specifications in Korea. In this regard, we continue to pursue and perform our research on the analytical method development for the items being researched and reviewed. In this study, we have developed a sensitive and selective test method that could simultaneously separate and determinate six major bioactive flavonolignans in silymarin, which are based on the use of a liquid chromatographic-tandem mass spectrometry (LC-MS/MS). The standard calibration curves presented a linearity effect with the correlation coefficient ($r^2$) > 0.999. The limits of detection (LODs) and limits of quantitation (LOQs) were in the range of $0.3{\sim}9.0{\mu}g/L$ and $0.8{\sim}27.3{\mu}g/L$, respectively. The recovery results ranged between 96.2~98.6% at 3 different concentration levels, and its relative standard deviations (RSDs) were less than 5% as noted in this study. The proposed analytical method was characterized with a noted high resolution of the individual silymarin constituents, and the assay was fully validated as well. Our research can provide a significant scientific evidence that can be useful to amend the silymarin test method for the Health Functional Food Code.

Investigation of Unintentionally Hazardous Substance in Commercial Herbs for Food and Medicine (유통 식약공용농산물 중 비의도적 유해물질 오염도 조사)

  • Seo, Mi-Young;Kim, Myung-Gil;Kim, Jae-Kwan;Jang, Mi-Kyung;Lee, Yu-Na;Ku, Eun-Jung;Park, Kwang-Hee;Yoon, Mi-Hye
    • Journal of Food Hygiene and Safety
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    • v.33 no.6
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    • pp.453-459
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    • 2018
  • This study was performed to investigate the contamination levels of heavy metals (such as lead, cadmium, arsenic and mercury) and aflatoxin (such as $B_1$, $B_2$, $G_1$ and $G_2$) in commercial herbs for food and medicine. The concentrations of the heavy metals were measured by the ICP-MS and a mercury analyzer. The aflatoxins were analyzed by a HPLC-florescence coupled with photochemical derivatization. The detection ranges of the lead, cadmium, arsenic and mercury were found to be 0.006~4.088 mg/kg, 0.002~2.150 mg/kg, ND~0.610 mg/kg and ND~0.0139 mg/kg respectively. Among the total samples, the 3 samples (2.6%) were not suitable for the specification of cadmium by the MFDS (Ministry of Food and Drug Safety). The 13 samples of the total 117 samples were aflatoxin positive (11.1%). The amount of aflatoxin $G_1$ was $0.7834{\mu}g/kg$ in the Puerariae Radix and aflatoxin $G_2$ were $0.3517{\mu}g/kg$, $0.4881{\mu}g/kg$ in two samples of the Glycyrrhizae Radix et Rhizoma, respectively. The aflatoxins $B_2$ and $G_1$ were simultaneously detected in the 10 Angelicae Gigantis Radix. The detection ranges of aflatoxins $B_2$ and $G_1$ were $0.2324{\sim}1.0358{\mu}g/kg$ and $0.7552{\sim}1.6545{\mu}g/kg$ respectively in Angelicae Gigantis Radix. The results of the current study suggest that continuous monitoring is needed for the proactive management of commercial herbs for food and medicine safety.

Development of a Simultaneous Analytical Method for Determination of Herbicide Fenquinotrione and KIH-3653-M-2 Residues in Agricultural Crops using LC-MS/MS (LC-MS/MS를 이용한 농산물 중 제초제 fenquinotrione 및 대사산물 KIH-3653-M-2 동시시험법 개발)

  • Park, Ji-Su;Do, Jung-Ah;Lee, Han Sol;Cho, Sung Min;Shin, Hye-Sun;Jang, Dong Eun;Jung, Yong-hyun;Lee, Kangbong
    • Journal of Food Hygiene and Safety
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    • v.34 no.3
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    • pp.242-250
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    • 2019
  • An analytical method was developed for the determination of fenquinotrione, a triketone herbicide, in agricultural products. Fenquinotrione was metabolized to KIH-3653-M-2 in plants. Analyte extraction was conducted using 2% formic acid in acetonitrile and cleaned up using a hydrophillic-lipophillic balance (HLB) cartridge. The limits of detection (LOD) and quantification (LOQ) were 0.004 and 0.01 mg/kg, respectively. Matrix-matched calibration curves were linear over the calibration ranges ($0.001{\sim}0.1{\mu}g/mL$) into a blank extract with $r^2>0.99$. The recovery results for fenquinotrione and KIH-3653-M-2 ranged between 81.1 to 116.2% and 78.0 to 110.0% at different concentration levels (LOQ, $10{\times}LOQ$, $50{\times}LOQ$) with relative standard deviation (RSD) less than 4.6%. All values were corresponded with the criteria ranges requested in both the Codex (CAC/GL 40-1993, 2003) and MFDS guidelines (2016). Therefore, the proposed method can be used as an official analytical method for determination of fenquinotrione in the Republic of Korea.

Determination of Mycotoxins in Agricultural Products Used for Food and Medicine Using Liquid Chromatography Triple Quadrupole Mass Spectrometry and Their Risk Assessment (LC-MS/MS를 이용한 식·약 공용 농산물의 곰팡이독소 분석 및 위해평가)

  • Choi, Su-Jeong;Ko, Suk-Kyung;Park, Young-Ae;Jung, Sam-Ju;Choi, Eun-Jung;Kim, Hee-sun;Kim, Eun-Jung;Hwang, In-Sook;Shin, Gi-Young;Yu, In-Sil;Shin, Yong-Seung
    • Journal of Food Hygiene and Safety
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    • v.36 no.1
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    • pp.24-33
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    • 2021
  • For this study, we surveyed concentrations of 8 mycotoxins (aflatoxin B1, B2, G1, G2, ochratoxin A, fumonisin B1, B2 and zearalenone) in agricultural products used for food and medicine by liquid chromatography-tandem mass spectrometry and conducted a risk assessment. Samples were collected at the Yangnyeong Market in Seoul, Korea, between January and November 2019. Mycotoxins were extracted from these samples by adding 0.1% formic acid in 50% acetonitrile and cleaned up by using an ISOLUTE Myco cartridge. The method was validated by assessing its matrix effects, linearity, limit of detection (LOD), limit of quantification (LOQ), recovery and precision using four representative matrices. Matrix-matched standard calibration was used for quantification and the calibration curves of all analytes showed good linearity (r2>0.9999). LODs and LOQs were in the range of 0.02-0.11 ㎍/kg and 0.06-0.26 ㎍/kg, respectively. Sample recoveries were from 81.2 to 118.7% and relative standard deviations lower than 8.90%. The method developed in this study was applied to analyze a total of 187 samples, and aflatoxin B1 was detected at the range of 1.18-7.29 ㎍/kg (below the maximum allowable limit set by the Ministry of Food and Drug Safety, MFDS), whereas aflatoxin B2, G1 and G2 were not detected. Mycotoxins that are not regulated presently in Korea were also detected: fumonisin (0.84-14.25 ㎍/kg), ochratoxin A (0.76-17.42 ㎍/kg), and zearalenone (1.73-15.96 ㎍/kg). Risk assessment was evaluated by using estimated daily intake (EDI) and specific guideline values. These results indicate that the overall exposure level of Koreans to mycotoxins due to the intake of agricultural products used for food and medicine is unlikely to be a major risk factor for their health.

Comparison between Different Industrial GDPs to Understand the Importance of the Industry: Focusing on the Food, Medical & Drug Industry (산업별 GDP 중요도 비교 분석: 식의약 산업 부문 GDP를 중심으로)

  • Kim, Sohye;Kim, Jinmin;Kim, Jaeyoung;Kang, Byung-Goo
    • Knowledge Management Research
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    • v.22 no.4
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    • pp.103-118
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    • 2021
  • Gross Domestic Product(GDP) is affected by the economic power of each industry. Therefore, using statistical data related to the food and drug industry, we tried to determine the proportion of GDP and analyzed the impact of the food, medical & drug industry on the domestic economy through comparison with other industries. The food, medical & drug industry has a wide range of industries among domestic industries and is closely related to the lives of the people. In addition, human lifespan is increasing, and recently, due to the spread of an infectious disease called COVID-19, the bio sector belonging to the food, medical & drug industry is in the spotlight. Attention is needed to the industry as the competitiveness of the food, medical & drug industry is expected to increase. The Ministry of Food and Drug Safety provides statistics on the food, medical & drug industry, but does not provide a systematic share of GDP. Since it is difficult to determine how influential the industry is compared to other industries, this study attempts to obtain the share of GDP in the food, medical & drug industry and compare it with other industries. In the process of obtaining GDP in the food, medical & drug industry sector, there was a difficulty in that the figures in statistical data were not unified by time point. In order to overcome the limitations, statistical data as a standard are determined. The GDP of the Food, Medical & Drug Industry was estimated using total added value, production, sales, and added value by industry. Compared to other industries, the Food, Medical & Drug Industry's GDP ranked second after the GDP of the manufacturing industry. As a result, it suggests that the food, medical & drug industry has a great influence on the national economic power among domestic industries.