• Title/Summary/Keyword: MFDS

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Residual Characteristics of Lufenuron in Crown Daisy and Chamnamul for Establishing Pre-Harvest Residue Limit (쑥갓 및 참나물 중 Lufenuron의 생산단계 잔류허용기준 설정을 위한 잔류 특성 연구)

  • A-Yeon Oh;Sun-Woo Ban;Hee-Ra Chang
    • Korean Journal of Environmental Agriculture
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    • v.42 no.1
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    • pp.21-27
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    • 2023
  • Pre-harvest residue limits (PHRLs) have been proposed as criteria for a proactive role to exceed the maximum residue limit (MRL) of pesticides in agricultural products at harvest. However, PHRL numbers are significantly less than those of established MRLs. This study was performed to determine the dissipation constants and residual concentrations of lufenuron after application on crown daisy and chamnamul under green house conditions. Two residue field trials for each crown daisy and chamnamul were selected to consider a different geographical site at least 20 km far from one another. The pesticide was treated according to critical GAP. After samples were sprayed with lufenuron, they were collected at 0, 1, 3, 5, 7, 10, and 14 days and analyzed using HPLC-DAD. The mean recoveries of crown daisy and chamnamul were within the range of 70-120% with below 20% coefficient variation, which is within the acceptable limits specified by the manual of pre-harvest residue study for pesticides (MFDS, 2014). The biological half-lives in field I and field II were 7.0 and 4.6 days for crown daisy and 2.7 and 2.8 days for chamnamul, respectively. The lower bounds of 95% confidence intervals of dissipation rate constants of lufenuron in crown daisy were determined to be 0.0692 and 0.1298 for field I and field II, respectively, and in chamnamul were 0.2067 for both field I and field II. After applying lufenuron 5% EC, the lufenuron residues on crown daisy and chamnamul at the pre-harvest intervals (14 days for crown daisy and 7 days for chamnamul) were below the safe levels. The dissipation rates of lufenuron in crown daisy and chamnamul were evaluated for similarities with leafy vegetables based on a 95% confidence interval.

Signal Detection of Adverse Event of Metoclopramide in Korea Adverse Event Reporting System (KAERS) (의약품부작용보고시스템을 이용한 메토클로프라미드의 이상사례 실마리정보 도출)

  • Min-Gyo Jang;Yeonghwa Lee;Hyunsuk Jeong;Kwang-Hee Shin
    • Korean Journal of Clinical Pharmacy
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    • v.33 no.2
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    • pp.122-127
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    • 2023
  • Background: This study was aimed to identify the safety signals of metoclopramide in Korea Adverse Event Reporting System (KAERS) database by proportionality analysis methods. Methods: The study was conducted using Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through KAERS. Signals of metoclopramide that satisfied the data-mining indices of proportional reporting ratio (PRR), reporting odds ratio (ROR) and information component (IC) were defined. The detected signals were checked whether they included in drug labels in the Ministry of Food and Drug Safety (MFDS), U.S. Food and Drug Administration (FDA) and Micromedex®. Results: A total number of drug AE reports associated with all drugs of data in this study was 2,665,429. Among them, the number of AE reports associated with metoclopramide was 22,583. Forty-two meaningful signals of metoclopramide were detected that satisfied with the criteria of data-mining indicies. Especially neurological signals including extrapyramidal reactions, represented in the safety letter of regulatory agencies were identified in this study. Conclusion: Neurological signals of metoclopramide including extrapyramidal reactions were detected. It is believed that this search for signals can contribute to ensuring safety in the use of metoclopramide.

Evaluation of Microbial Analysis and Application of Reduction Technology in a Dairy Factory (목장형 유가공장의 미생물 분석 및 저감기술 적용 평가)

  • Jong-Hui Kim;Eun-Seon Lee;Bu-Min Kim;Jun-Sang Ham;Mi-Hwa Oh
    • Journal of Dairy Science and Biotechnology
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    • v.41 no.4
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    • pp.203-210
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    • 2023
  • Bacterial contamination negatively affects the quality, functionality, and safety of dairy products. Adherent populations of bacteria, referred to as biofilms, grow on the surfaces of dairy processing equipment and are the primary cause of dairy contamination. In addition, microorganisms present in the farm environment and dairy factory can contaminate the Clear-In-Place (CIP) line through raw milk transport pipes; therefore, exhaustive management is required. In dairy manufacturing facilities, biofilm formation is controlled using CIP systems that primarily require sodium hydroxide and nitric acid. However, the leakage or incomplete removal of these potently active compounds can be harmful to humans. In the present study, we compared the eradication of Escherichia coli and other bacteria using commercially available combinations of sodium hypochlorite (NaClO) and citric acid, which are recognized by the Korean Ministry of Food and Drug Safety (MFDS) as food disinfectants. When considered in the CIP system of the field manufacturing process, E. coli was not detected (compared to detection before treatment), and other bacteria were detected at 0-32 culture-forming units (CFU)/cm2. The residual amount of chlorine ions after CIP treatment was similar to that in tap water, and there was no significant difference in the overall components of the fermented dairy products. Therefore, the NaClO/citric acid CIP system can be safely applied in dairy manufacturing processes.

Recent Progress in Mussel-inspired Catechol-conjugated Chitosan Hemostats (홍합 모사 카테콜기가 도입된 키토산 지혈제 연구 동향)

  • Seongyeon Jo;Soomi Kim;Chanwoo Park;Seungwon Hong;Hong Kee Kim;Ji Hyun Ryu
    • Journal of Adhesion and Interface
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    • v.24 no.4
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    • pp.113-119
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    • 2023
  • Since it was reported that the unusual amino acid DOPA in synergy with lysine and histidine residues found in mussel adhesive proteins plays a pivotal role in mussel adhesion in underwater environments, there has been a burgeoning development of various catecholamines-based adhesives for biomedical applications. Among these, catechol-conjugated chitosan, containing catecholamine, featuring multiple catechol groups within its aminerich chitosan backbone, has found versatile utility in fields, such as tissue adhesion, wound dressing, tissue healing, hemostats, drug delivery systems, and tissue engineering scaffolds. Significantly, chitosan-catechol is a mussel-inspired material approved by both US Food and Drug Administration (FDA) and KR Ministry of Food and Drug Safety (MFDS) for its effectiveness in hemostasis. This review focuses on 1) general aspects of catechol-conjugated chitosan, highlighting catechol group integration into chitosan backbones, 2) examination of proposed mechanisms of hemostasis, and 3) exploration of diverse physical forms, including solution, hydrogels, patches, and thin films with practical applications inapplicable to hemostasis.

A Study on Development of Guideline on Writing Technical Document for Electrical Medical Devices: Dental X-ray Equipment (치과용엑스선장치의 기술문서 작성을 위한 가이드라인 개발 연구)

  • Lee, Seung-Youl;Kim, Jae-Ryang;Lee, Jun-Ho;Park, Chang-Won
    • Journal of radiological science and technology
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    • v.39 no.4
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    • pp.651-660
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    • 2016
  • Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts.

Monitoring of Microorganism Contamination in Children-Preferred Confectioneries in Korea (서울·경인지역 유통판매중인 과자류의 위생지표 세균 및 식중독균 오염도 조사)

  • Koo, Eun Joo;Chung, So Young;Park, Ji Eun;Kwon, Yu Jihn;Seo, Dong Hyuk;Jung, Yu Young;Cho, Kyong Chul;Lee, Yo A;Min, Hee Eun;Kim, Eu Gene;Kim, Hyun Jung;Kim, Seul Ki;Choi, Sun Ok;Lim, Chul Ju
    • Journal of Food Hygiene and Safety
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    • v.29 no.4
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    • pp.322-326
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    • 2014
  • According to Centers for Disease Control and Prevention (CDC, USA) recently it was reported that the children (< 5 year-old children) were more susceptible to Foodborne-illness. Confectionery products should be strictly controlled because they are children-preferred foods. Ministry of Food and Drug Safety (MFDS, South of Korea) tried to monitor contamination of organisms in confectionery products (such as biscuits, candies, chewing gums and ice candies) distributed in South Korea. MFDS evaluated the levels of indicator organisms: total aerobic bacteria, coliforms, Escherichia coli as well as the levels of food-borne illness organisms: Staphylococcus aureus, Bacillus cereus, Clostridium perfringens. Experimental plans for microbiological test were in accordance with the International Commission on Microbiological Specifications for Food (ICMSF). For this study, 1,005 samples were collected and from Seoul and Gyeongin region, South Korea. The average level of total aerobic bacteria in 1,005 samples was 1.7 log Colony Forming Unit(CFU)/g and the detection rate was 26.8%. The average level of Bacillus cereus was detected in 1.7 log CFU/g and the rate was 0.9%. There was no detection of coliforms, Escherichia coli, Staphylococcus aureus and Clostridium perfringens. The results of this study will be provided as the basic data to set the reasonable microbiological criteria of Korea Food Code.

Developed an output device for high-frequency cosmetic medical equipment using micro multi-needle (마이크로 멀티니들을 이용한 고주파 피부미용 의료기기를 위한 출력 장치 개발)

  • Kim, Jun-tae;Joo, Kyu-tai;Cha, Eun Jong;Kim, Myung-mi;Jeong, Jin-hyoung
    • The Journal of Korea Institute of Information, Electronics, and Communication Technology
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    • v.14 no.5
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    • pp.394-402
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    • 2021
  • The entry of an aging society and the extension of human life expectancy, the increasing interest in women's social advancement and men's appearance, and the natural interest in K-culture through media media, while receiving worldwide attention, Focus on K-Bueaty. Recently, looking at the occupation of the medical tourism field, in the case of aesthetic medicine tourism such as molding and dermatology, it has gained popularity not only in Asia such as China and Japan, but also in North America and Europe. The first external confirmation of human aging is the wrinkles on the skin of the face. Clean, wrinkle-free, elastic and healthy skin is a desire of most people. Skin condition and condition such as focused ultrasonic stimulation (HIFU: High Intensity Focused Utrasound) and low frequency, high frequency (RF: Radio Frequency), galvanic therapy using microcurrent, cryotherapy using rapid cooling, etc. Depending on the method of management, the effect of the treatment differs depending on the output and the stimulation site, etc., even in the treatment of medical equipment and beauty equipment using the same mechanism. In this research, in order to develop invasive high-frequency dermatological devices using a large number of beauty medical devices and microneedles of beauty devices, the international standards IEC 60601-2 (standards for individual medical devices) and MFDS (Ministry of) We designed and developed a high-frequency output device in compliance with the high-frequency stimulation standard announced in the Food and Drug Safety (Ministry of Food and Drug Safety). The circuit design consists of an amplifier (AMP: Amplifier) using Class-A Topology and a power supply device using Half-Bridge Topology. As a result of measuring the developed high-frequency output device, an average efficiency of 63.86% was obtained, and the maximum output was measured at 116.7W and 50.67dBm.

QuEChERS-based determination of tissue residues and acute toxicity of pyraclofos in rat (QuEChERS 법을 이용한 Rat 조직내 Pyraclofos 잔류 분석 및 급성독성 평가)

  • Pyo, Min-Jung;Hah, Do-Yun;Choi, You-Jeong;Jeong, Kwi-Ok;Han, Chang-Hee;Park, Young-Ho;Kim, Min-Hee;Kim, Won-Gyu;Jung, Jing-Gune;Kim, Munki;Kim, Euikyung
    • 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.

Analytical Method Development for Determination of Coenzyme Q10 by LC-MS/MS in Related Health Functional Foods (건강기능식품에서 LC-MS/MS를 이용한 코엔자임Q10 분석법 연구)

  • Lee, Jin Hee;Oh, Mihyune
    • Journal of Food Hygiene and Safety
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    • v.34 no.6
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    • pp.519-525
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    • 2019
  • The Ministry of Food and Drug Safety (MFDS) is amending its test methods for health functional foods (dietary food supplements) to establish regulatory standards and specifications in Korea. In this regard, we are continuing our research on analytical method development for the items listed in the Korean Health Functional Food Codex. In this study, we have developed a sensitive and selective test method that could simultaneously separate and determine coenzyme Q10 based on liquid chromatographic-tandem mass spectrometry (LC-MS/MS). Calibration curves showed linearity with a correlation coefficient (R2) of > 0.999 and the limits of detection (LODs) and limits of quantitation (LOQs) were in the range of 26.0 ㎍/L and 78.9 ㎍/L, respectively. The recovery results ranged between 98.6-107.0% at 3 different concentration levels with relative standard deviations (RSDs) less than 5%. The proposed analytical method was characterized with high resolution of the coenzyme Q10 and the assay was fully validated as well.

Distribution and Toxin Gene Characteristic of Bacillus cereus Isolated from Foods in Busan (부산지역 가공식품 중 Bacillus cereus 분포 현황 및 독소 유전자 특성)

  • Park, So-hyun;Gwon, Wi-Gyeong;Lee, In-sook;Kim, Eun-ju;Hwang, Su-jeong;Koo, Hee-soo;Na, Young-ran;Kim, Byung-jun;Park, Eun-hee;Lee, Mee-ok
    • Journal of Food Hygiene and Safety
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    • v.35 no.3
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    • pp.219-224
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    • 2020
  • The purpose of this study was to provide basic data necessary for the prevention of food poisoning and safe food management. We examined 872 food samples for B. cereus in accordance with the MFDS Food Code and investigated characteristics of their harboring toxin genes. We detected and isolated 113 strains of B. cereus from 78 food samples (8.9%), and the average detection level was 48 CFU/g. B. cereus isolates carried at least 1 toxin gene among the emetic toxins and 5 enterotoxin genes. The toxin gene profiles of B. cereus were classified into 18 different types of isolates showing genetic diversity. Among the strains, 34 (30.1%) had all 5 enterotoxin genes (Cytk-nheA-entFM-bceT-hblC), accounting for the highest percentage. The entFM and nheA genes were major enterotoxin genes, while the emetic toxin gene, CER, was the least detected in B. cereus isolated from food samples.