• Title/Summary/Keyword: Drug safety assessment

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Monitoring of Pesticide Residues and Risk Assessment of Agricultural Products Consumed in South Korea (국내유통농산물 중 잔류농약 모니터링 및 안전성 평가)

  • Kim, Sung-Hun;Choe, Won-Jo;Baik, Yong-Kyoo;Kim, Woo-Seong
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.37 no.11
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    • pp.1515-1522
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    • 2008
  • Monitoring the pesticide residues in agricultural products is essential to protect consumers, obtain data for risk assessment, and ensure fair trade practices. We developed a multi-residue method for the analysis of 37 pesticides with different physico-chemical properties in agricultural products and analyzed the amount of pesticide residues on about 1,000 samples circulated in South Korea. The samples consisted of 26 different types of agricultural products selected at markets in 14 major cities; cereals (2 species), nuts (1 species) potatoes (1 species), beans (2 species), fruits (3 species), vegetables (16 species), and mushrooms (1 species). In this study, residual pesticides were detected in 23 samples (2.2%) and one sample was detected to be over maximum residue limits (MRLs, 0.1%) for pesticides in foods by the Korea food code. In leafy vegetables such as pepper leaves, radish leaves, cham-na-mul, shin-sun-cho, crown daisy, chwi-na-mul and citrus fruits such as kumquat, 8 kinds of pesticides were detected. Specially, diazinon were detected over MRLs and also, endosulfan, ethoprophos and phenthoate were detected frequently. Based on these results, we investigated the risk assesment from amount of residual pesticide, total %ADI was 1.262%, but the value has not effected on human health.

A Study on Establishing a Standardized Process for the Development and Management of Food Safety Health Indicators in Korea (우리나라 식품안전보건지표의 개발 및 운용과정 정립에 대한 연구)

  • Byun, Garam;Choi, Giehae;Lee, Jong-Tae
    • Journal of Food Hygiene and Safety
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    • v.30 no.3
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    • pp.217-226
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    • 2015
  • This study was conducted to establish a standardized process for developing food safety health indicators. With this aim, we proposed a standardized process, accessed the validity of the suggested process by performing simulations, and provided a method to utilize the indicators. Developing process for domestic environmental health indicators was benchmarked to propose a standardized process for developing food safety health indicators, and DPSEEA framework was applied to the development of indicators. The suggested standardized process consists of an exploitation stage and a management stage. In the exploitation stage, a total of 6 procedures (initial indicators suggestion, candidate indicators selection, data availability assessment, feasibility assessment, pilot study, and final indicator selection) are conducted, and the indicators are routinely calculated and officially announced in the management stage. The exploitation stage is operated by an interaction between a task force team who manages the overall process, and an advisory committee (minimum of 4 in academia, 2 in research, 4 in specialists of Ministry of Food and Drug Safety) who reviews and performs evaluations on the indicators. The standardized process was simulated with 45 initial indicators, and total of 4 indicators (17 detailed indicators) were selected: 'Proportion of domestic fruit/vegetable receiving 'acceptable' in the evaluation of pesticide/herbicide residues', 'Food-borne disease outbreaks', 'Food-borne legal infectious disease incidence', 'Salmonellosis incidence'. Synthetic food safety health index was derived by calculating percent difference with the data from 2010 to 2012. Results showed that when comparing the year 2010 to 2011, and 2011 to 2012, the overall food safety status improved by 10.37% and 9.87%, respectively. In addition, the contribution of indicators to the overall food safety status can be determined by looking into the individual indicators, and the synthetic index may be illustrated to enhance the ease of interpretation to the public and policy makers. In overall, food health safety indicators can be useful in many ways and therefore, attention should be drawn to conduct further studies and establish related legislations.

Chemical Risk Factors for Children's Health and Research Strategy (어린이 건강관련 유해물질 연구방향)

  • Lee, Hyo-Min;Jung, Ki-Hwa
    • Journal of Food Hygiene and Safety
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    • v.23 no.3
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    • pp.276-283
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    • 2008
  • To provide the research strategy for protection of children's health from hazardous chemical, we reviewed the hazardous chemicals can be exposed through maternity, children's life style and living environment. Recently, diseases related with children's living condition were focused as asthma, atopy, childhood developmental disability, congenital malformations and obesity. Children can be exposed to hazardous chemicals through an ambient air, water, soil, food, toys and other factors such as floor dust. Also children's health was deeply related with a wrong life style and neglectful caring by a lack of knowledge and information of harmful ones at parents and child care center's nursers. According to the previous study, the chemical risk factor of children's health were identified as inorganic arsenic, bisphenol A, 2,4-D, dichlorvos, methylmercury, PCBs, pesticide, phthalates, PFOA/PFOS, vinyl chloride, et al. Domestic studies for identification of causality between children exposure to chemicals and resulted hazardous effects were not implemented. The confirmation of chemical risk factors through simultaneously performing toxicological analysis, human effect study, environmental/human monitoring, and risk assessment is needed for good risk management. And also, inter-agency collaboration and sharing information can support confirming scientific evidence and good decision making.

Dental alloplastic bone substitutes currently available in Korea

  • Ku, Jeong-Kui;Hong, Inseok;Lee, Bu-Kyu;Yun, Pil-Young;Lee, Jeong Keun
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.45 no.2
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    • pp.51-67
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    • 2019
  • As dental implant surgery and bone grafts were widely operated in Korean dentist, many bone substitutes are commercially available, currently. For commercially used in Korea, all bone substitutes are firstly evaluated by the Ministry of Health and Welfare (MOHW) for safety and efficacy of the product. After being priced, classified, and registration by the Health Insurance Review and Assessment Service (HIRA), the post-application management is obligatory for the manufacturer (or representative importer) to receive a certificate of Good Manufacturing Practice by Ministry of Food and Drug Safety. Currently, bone substitutes are broadly classified into C group (bone union and fracture fixation), T group (human tissue), L group (general and dental material) and non-insurance material group in MOHW notification No. 2018-248. Among them, bone substitutes classified as dental materials (L7) are divided as xenograft and alloplastic bone graft. The purpose of this paper is to analyze alloplastic bone substitutes of 37 products in MOHW notification No. 2018-248 and to evaluate the reference level based on the ISI Web of Knowledge, PubMed, EMBASE (1980-2019), Cochrane Database, and Google Scholar using the criteria of registered or trademarked product name.

Cytotoxicity(MTT) evaluation of dental instruments made of polymers (치과용 폴리머 기구의 세포독성(MTT) 평가)

  • Choi, Eun-Mi
    • Journal of the Korea Convergence Society
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    • v.12 no.8
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    • pp.187-195
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    • 2021
  • In order to assess the cell toxicity of 10 instruments made of polymers, the MTT assay which utilizes the L-929 cell was selected. Specimens were eluted at a temperature of 37℃ for 24 hours at a rate of 4g per 20mL, RPMI 1640, and then was positively and negatively contrasted with a control test solution, in accordance with the Notification No. 2020-12 Protocols of Medical Apparatus Biological Safety from the Ministry of Drug and Food Safety. As a result of 24 hours of incubation in 37℃, 5% CO2 Incubator and assessment using an ELISA reader, the results of Intraoral camera indiciated a cellular viability of more than 70% at a 50% eluate. But, the Plastic impression tray, 3D printing tweezer, Impression disposable syringe, Dental floss holder, Hand implant scaler, Surgical retractor, Oral scanner tip, Dental mirror, and the Water pick tip all reported a cellular viability of more than 70% at a 100% eluate, which indicates that do not exhibit cytotoxicity, thus allowing it to be used in contact with the mucous membrane of the oral cavity.

A Study on Safety and Performance Evaluation of Smart All-in-one Cardiopulmonary Assist Device (스마트올인원 심폐순환보조장치의 안전성 및 성능평가에 관한 연구)

  • Park, Junhyun;Ho, YeJi;Lee, Yerim;Lee, Duck Hee;Choi, Jaesoon
    • Journal of Biomedical Engineering Research
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    • v.40 no.5
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    • pp.197-205
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    • 2019
  • The existing Extracorporeal membrane oxygenation(ECMO) and Cardiopulmonary bypass system(CPB) have been developed and applied to various devices according to their respective indications. However, due to the complicated configuration and difficult usage method, it causes inconvenience to users and there is a risk of an accident. Therefore, smart all-in-one cardiopulmonary circulation device is being developed recently. The smart all-in-one cardiopulmonary assist device consists of a blood pump for cardiopulmonary bypass, a blood oxidizer for cardiopulmonary bypass, a blood circuit for cardiopulmonary bypass, and an artificial cardiopulmonary device. It is an integrated cardiopulmonary bypass device that can be used for a variety of purposes such as emergency, intraoperative, post-operative intensive care, and long-term cardiopulmonary assist, combined with CPB used in open heart surgery and ECMO used when patient's cardiopulmonary function does not work normally. The smart all-in-one cardiopulmonary assist device does not exist as a standard and international standard applicable to advanced medical devices. Therefore, in this study, we will refer to the International Standard for Blood Components, the International Standard for Blood, the Guideline for Blood Products, and prepare applicable performance and safety guidelines to help quality control of medical devices, and contribute to the improvement of the health of people. The guideline, which is the result of conducted a survey of the method of safety and performance test, is based on the principle of all-in-one cardiopulmonary aiding device, related domestic foreign standards, the status of domestic and foreign patents, related literature, blood pump(ISO 18242), blood oxygenator (ISO 7199), and blood circuit (ISO 15676) for cardiopulmonary bypass.The items on blood safety are as follows: American Society for Testing and Materials ASTM F1841-97R17), and in the 2010 Food and Drug Administration's Safety Assessment Guidelines for Medical Assisted Circulatory Devices. In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers / importers, testing inspectors, academia, etc. the final guideline was established through revision and supplementation process. Therefore, we propose guidelines for evaluating the safety and performance of smart all-in-one cardiopulmonary assist devices in line with growing technology.

Arsenic species in husked and polished rice grains grown at the non-contaminated paddy soils in Korea (국내 비오염 논토양에서 재배한 현미와 백미 중 비소화학종 함량)

  • Kim, Da-Young;Kim, Ji-Young;Kim, Kye-Hoon;Kim, Kwon-Rae;Kim, Hyuck-Soo;Kim, Jeong-Gyu;Kim, Won-Il
    • Journal of Applied Biological Chemistry
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    • v.61 no.4
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    • pp.391-395
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    • 2018
  • There is an increasing concern over arsenic (As) contamination of paddy soil and rice with regard to food safety. This study was conducted to investigate total and inorganic As concentration in one hundred husked and polished rice samples collected at the non-contaminated paddy soil in Korea. Arsenic species in rice samples were extracted using 1% nitric acid ($HNO_3$) with a microwave oven and were measured using high performance liquid chromatography coupled with inductively coupled plasma-mass spectrometry. Mean concentrations of total As in husked rice and polished rice were 0.18 and $0.11mg\;kg^{-1}$, respectively. Also, average inorganic As concentrations in husked rice and polished rice were 0.11 and $0.07mg\;kg^{-1}$, respectively. These levels are lower than the standard guideline value 0.35 and $0.2mg\;kg^{-1}$ for inorganic As in husked and polished rice recommended by Codex Committee on Contaminants in Foods and Ministry of Food and Drug Safety, respectively. The mean of the inorganic As ratio for the total amount of As was 0.65 and 0.67 for husked rice and polished rice, respectively, and the range was from 0.08 to 1.0. For health risk assessment, the average value of cancer risk probability was $9.24{\times}10^{-5}$ and ranged from $2.30{\times}10^{-5}$ to $1.90{\times}10^{-5}$. Therefore, human exposure to As through dietary intake of surveyed rice samples might considered to be a low health risk.

Current Assessment of Sodium and Potassium Intakes in Elementary and Middle School Students through School Meals (초.중학교 학교급식 중 나트륨, 칼륨 섭취실태 조사)

  • Lee, Sun-Kyu;Chang, Eun-Jung;Choi, Jae-Chun;Bahn, Kyeong-Nyeo;Kim, Mee-Hye
    • Korean Journal of Food Science and Technology
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    • v.42 no.5
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    • pp.578-585
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    • 2010
  • The purpose of this research was to estimate dietary sodium exposure and to determine the sodium contents of school lunches in Incheon and Gangwon. In this study, we collected 1,334 samples from 8 elementary schools and 8 middle schools for 15 days. The average lunch intakes at the elementary and middle schools were $381.2{\pm}73.8g$ and $460.4{\pm}81.5g$, respectively. The sodium contents of main dishes, side dishes, and desserts were $49.7{\pm}105.6$ mg/100 g, $517.2{\pm}409.2$ mg/100 g, and $135.4{\pm}195.5$ mg/100 g, respectively. The average sodium intakes through lunch at the elementary and middle schools were $863.0{\pm}291.1$ mg and $1,052.1{\pm}323.4$ mg, and average potassium intakes were $571.1{\pm}193.0$ mg and $655.8{\pm}198.4$ mg, respectively. The results of this study show that sodium intake from school lunches is about 47% of the recommended daily intake (RDI, 2,000 mg per day) established by the WHO. Therefore, it is recommended that sodium exposure be continuously monitored.

Assessment of Estimated Daily Intake of Sweeteners in the Korean Population (한국인의 인공감미료 섭취수준 평가)

  • Choi, Sung-Hee;Lee, Man-Sool;Park, Eun-Young;Won, Jun;Kim, So-Hee;Park, Sung-Kwan;Lim, Ho-Soo
    • Korean Journal of Food Science and Technology
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    • v.43 no.3
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    • pp.387-395
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    • 2011
  • We analyzed the estimated daily intake of sweeteners in the Korean population, using data from national health and nutrition studies regarding the concentration of sweetener in each type of food, food intake by gender, age group, and weight. The level of safety of these sweeteners was evaluated by comparisons with the acceptable daily intake (ADI) data established by the Joint FAO/WHO expert committee on food additives. The estimated daily intake (EDI) of sodium saccharin was $52.31{\mu}g/kg{\cdot}bw$, $55.06{\mu}g/kg{\cdot}bw$ acesulpham-K, $145.47{\mu}g/kg{\cdot}bw$ aspartame, and $93.86{\mu}g/kg{\cdot}bw$ sucralose per day. The percentages in relation to ADI were 1.0%, 0.4%, 0.4%, and 0.6% respectively, which were all within safe levels. The relatively higher-consuming groups were taking $783.12{\mu}g/kg{\cdot}bw$ sodium saccharine, $4,399.09{\mu}g/kg{\cdot}bw$ aspartame, $1,557.09{\mu}g/kg{\cdot}bw$ acesulpham-k, and $2,700.72{\mu}g/kg{\cdot}bw$ sucralose per day, and their intake levels as a percentage of ADI were 15.7, 11.0, 10.4, and 18.0%, respectively, which were all within safe levels.

Quantitative Microbial Risk Assessment Model for Staphylococcus aureus in Kimbab (김밥에서의 Staphylococcus aureus에 대한 정량적 미생물위해평가 모델 개발)

  • Bahk, Gyung-Jin;Oh, Deog-Hwan;Ha, Sang-Do;Park, Ki-Hwan;Joung, Myung-Sub;Chun, Suk-Jo;Park, Jong-Seok;Woo, Gun-Jo;Hong, Chong-Hae
    • Korean Journal of Food Science and Technology
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    • v.37 no.3
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    • pp.484-491
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    • 2005
  • Quantitative microbial risk assessment (QMRA) analyzes potential hazard of microorganisms on public health and offers structured approach to assess risks associated with microorganisms in foods. This paper addresses specific risk management questions associated with Staphylococcus aureus in kimbab and improvement and dissemination of QMRA methodology, QMRA model was developed by constructing four nodes from retail to table pathway. Predictive microbial growth model and survey data were combined with probabilistic modeling to simulate levels of S. aureus in kimbab at time of consumption, Due to lack of dose-response models, final level of S. aureus in kimbeb was used as proxy for potential hazard level, based on which possibility of contamination over this level and consumption level of S. aureus through kimbab were estimated as 30.7% and 3.67 log cfu/g, respectively. Regression sensitivity results showed time-temperature during storage at selling was the most significant factor. These results suggested temperature control under $10^{\circ}C$ was critical control point for kimbab production to prevent growth of S. aureus and showed QMRA was useful for evaluation of factors influencing potential risk and could be applied directly to risk management.