• Title/Summary/Keyword: Safety Assessment Regulations

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Development and Research into Functional Foods from Hydrolyzed Whey Protein Powder with Sialic Acid as Its Index Component - I. Repeated 90-day Oral Administration Toxicity Test using Rats Administered Hydrolyzed Whey Protein Powder containing Normal Concentration of Sialic Acid (7%) with Enzyme Separation Method - (Sialic Acid를 지표성분으로 하는 유청가수분해단백분말의 기능성식품 개발연구 - I. 효소분리로 7% Siailc Acid가 표준적으로 함유된 유청가수분해단백분말(7%)의 랫드를 이용한 90일 반복경구투여 독성시험 평가 연구 -)

  • Noh, Hye-Ji;Cho, Hyang-Hyun;Kim, Hee-Kyong
    • Journal of Dairy Science and Biotechnology
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    • v.34 no.2
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    • pp.99-116
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    • 2016
  • We herein performed animal safety assessment in accordance with Good Laboratory Practice (GLP) regulations with the aim of developing sialic acid from glycomacropeptide (hereafter referred to as "GMP") as an index ingredient and functional component in functional foods. GMP is a type of whey protein derived from milk and a safe food, with multiple functions, such as antiviral activity. A test substance was produced containing 7% (w/w) sialic acid and mostly-hydrolyzed whey protein (hereafter referred to as "7%-GNANA") by enzymatic treatment of substrate GMP. The maximum intake test dose level was selected based on 5,000 mg/kg/day dose set for male NOEL (no-observed-effect-level) and female NOAEL (no-observed-adverse-effect-level) determined by a dose-range finding (DRF) test (GLP Center of Catholic University of Daegu, Report No. 15-NREO-001) that was previously conducted with the same test substance. To evaluate the toxicity of a repeated oral dose of the test substance in connection with the previous DRF study, 1,250, 2,500, and 5,000 mg/kg of the substance were administered by a probe into the stomachs of 6-week-old SPF Sprague-Dawley male and female rats for 90 d. Each test group consisted of 10 male and 10 female rats. To determine the toxicity index, all parameters, such as observation of common signs; measurements of body weight and food consumption; ophthalmic examination; urinalysis, electrolyte, hematological, and serum biochemical examination; measurement of organ weights during autopsy; and visual and histopathological examinations were conducted according to GLP standards. After evaluating the results based on the test toxicity assessment criteria, it was determined that NOAEL of the test substance, 7%-GNANA, was 5,000 mg/kg/day, for both male and female rats. No animal death was noted in any of the test groups, including the control group, during the study period, and there was no significant difference associated with test substance, as compared with the control group, with respect to general symptoms, body weight changes, food consumption, ophthalmic examination, urinalysis, hematological and serum biochemical examination, and electrolyte and blood coagulation tests during the administration period (P<0.05). As assessed by the effects of the test substance on organ weights, food consumption, autopsy, and histopathological safety, change in kidney weight as an indicator of male NOAEL revealed up to 20% kidney weight increase in the high-dose group (5,000 mg/kg/day) compared with the change in the control group. However, it was concluded that this effect of the test substance was minor. In the case of female rats, reduction of food consumption, increase of kidney weight, and decrease of thymus weight were observed in the high-dose group. The kidney weight increased by 10.2% (left) and 8.9% (right) in the high-dose group, with a slight dose-dependency compared with that of the control group. It was observed that the thymus weight decreased by 25.3% in the high-dose group, but it was a minor test substance-associated effect. During the autopsy, botryoid tumor was detected on the ribs of one subject in the high-dose group, but we concluded that the tumor has been caused by a naturally occurring (non-test) substance. Histopathological examination revealed lesions on the kidney, liver, spleen, and other organs in the low-dose test group. Since these lesions were considered a separate phenomenon, or naturally occurring and associated with aging, it was checked whether any target organ showed clear symptoms caused by the test substance. In conclusion, different concentrations of the test substance were fed to rats and, consequently, it was verified that only a minor effect was associated with the test substance in the high-dose (5,000 mg/kg/day) group of both male and female rats, without any other significant effects associated with the test substance. Therefore, it was concluded that NOAEL of 7%-GNANA (product name: Helicobactrol) with male and female rats as test animals was 5,000 mg/kg/day, and it thus was determined that the substance is safe for the ultimate use as an ingredient of health functional foods.

Strategy for Development of HSE Management Framework for Offshore CCS Project in Korea (국내 해양 CCS 사업의 HSE 관리 프레임워크 구축 전략)

  • Noh, Hyonjeong;Kang, Kwangu;Kang, Seong-Gil;Lee, Jong-Gap
    • Journal of the Korean Society for Marine Environment & Energy
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    • v.20 no.1
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    • pp.26-36
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    • 2017
  • Korea is preparing an offshore carbon capture, transport and storage (CCS) demonstration project which is recognized as one of important $CO_2$ reduction technologies to mitigate climate change. The offshore CCS project aims to transport, inject and store large amount of $CO_2$ into offshore geologic formation, and has a potential risk of leakage which might cause disastrous damage to human health, environment and property. Therefore, in order to ensure the safety of the offshore CCS project, a strict HSE (health, safety and environment) management plan and its implementation are required throughout the project life cycle. However, there are no HSE domestic laws or regulations applicable to CCS projects, and the related research is insufficient in Korea. For the derivation of the essential and urgent requirement in HSE management framework applicable to the offshore CCS project in Korea, we analysed the HSE management methodologies and foreign CCS HSE management guidelines and cases. First, this paper has analyzed ISO 31000, a generalized risk management principles. Second, we have investigated the HSE management practices of CCS projects in Norway and UK. Based on the analyses, we suggested the necessity of developing the HSE Philosophy and the HSE management process through the whole life cycle. Application of HSE management in early phase of an offshore CCS project will promote systematic and successful project implementation in a cost-effective and safe way.

A Development of Facility Web Program for Small and Medium-Sized PSM Workplaces (중·소규모 공정안전관리 사업장의 웹 전산시스템 개발)

  • Kim, Young Suk;Park, Dal Jae
    • Korean Chemical Engineering Research
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    • v.60 no.3
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    • pp.334-346
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    • 2022
  • There is a lack of knowledge and information on the understanding and application of the Process Safety Management (PSM) system, recognized as a major cause of industrial accidents in small-and medium-sized workplaces. Hence, it is necessary to prepare a protocol to secure the practical and continuous levels of implementation for PSM and eliminate human errors through tracking management. However, insufficient research has been conducted on this. Therefore, this study investigated and analyzed the various violations in the administrative measures, based on the regulations announced by the Ministry of Employment and Labor, in approximately 200 small-and medium-sized PSM workplaces with fewer than 300 employees across in korea. This study intended to contribute to the prevention of major industrial accidents by developing a facility maintenance web program that removed human errors in small-and medium-sized workplaces. The major results are summarized as follows. First, It accessed the web via a QR code on a smart device to check the equipment's specification search function, cause of failure, and photos for the convenience of accessing the program, which made it possible to make requests for the it inspection and maintenance in real time. Second, it linked the identification of the targets to be changed, risk assessment, worker training, and pre-operation inspection with the program, which allowed the administrator to track all the procedures from start to finish. Third, it made it possible to predict the life of the equipment and verify its reliability based on the data accumulated through the registration of the pictures for improvements, repairs, time required, cost, etc. after the work was completed. It is suggested that these research results will be helpful in the practical and systematic operation of small-and medium-sized PSM workplaces. In addition, it can be utilized in a useful manner for the development and dissemination of a facility maintenance web program when establishing future smart factories in small-and medium-sized PSM workplaces under the direction of the government.

Analysis of the Disposal Rate of Fresh Frozen Femoral Head in the Bone Bank of a Single Hospital (단일 병원 인체조직은행에서 채취한 신선 동결 대퇴골두의 폐기율 분석)

  • Lee, Jaeyoung;Lee, Donghun;Jeon, Jinhwa;Lee, Kee Haeng
    • Journal of the Korean Orthopaedic Association
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    • v.56 no.4
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    • pp.305-309
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    • 2021
  • Purpose: This study analyzed the increase in disposal rate of femoral heads in the bone bank of a single hospital from medical disease and drug history, as assessed by the Korean health insurance review and assessment service. Materials and Methods: The disposal rate and cause of 340 femoral heads were analyzed according to the regulations of the bone bank based on the standard model of the Ministry of food and drug safety. Results: One hundred and seven (33%) of 323 femoral heads collected from 2009 to 2018, and 65 (46%) of 142 femoral heads collected from 2015 to 2018 were discarded. The most common causes were related to the history of dementia and the administration of radioisotope for nuclear medicine. Conclusion: The current methods and screening tools can lead to errors in disposing of the available tissues in a bone bank. Thus, improved standards and screening methods are needed.

Other Processed Products, Monitoring and the Exposed Dose Assessment of Heavy Metal, the Illegal Compounds (기타가공품의 중금속, 부정유해물질 모니터링 및 노출량 평가)

  • Jang, Jin-Seob;Kwon, Mun-Ju;Kim, Meyong-Hee;Park, Jin-Soo;Lim, Soo-Sun;Kwon, Sung-Hee;Song, Sung-Min;Yeo, Eun-Young;Hong, Seong-Hee;Kim, Jung-Im;Om, Ae-Son
    • Journal of Food Hygiene and Safety
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    • v.30 no.1
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    • pp.35-42
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    • 2015
  • This study was performed for both evaluating the safety of other processed products and providing basic information for making the general standard for contaminants in the category of other processed products. We analyzed the contents of three heavy metals, thirty six anti-impotence drugs and their analogues, three anti-obesity drugs and their analogues, twenty eight steroid drugs and their analogues, collecting in Incheon Metropolitan City. Any illegal compound was not detected in those products. However the contents of lead, cadmium and mercury of those products were at the range of 0.001-13.390 mg/kg, 0.03-1.231 mg/kg and 0.001-0.650 mg/kg respectively. Because there are no standards of heavy metals against other processed products, we compared the analytical results with relevant standards of both S. Korea and foreign countries. As a result, two products exceeded the relevant standards of lead, and other two products exceeded the relevant standards of mercury. The relative hazards compared to PTWI of FAO/WHO (Codex), Seafoods-pajeonmix, Perilla seed powder exceeded PTWI standards 0.214. The compulsory standards of each food product are determined by the category of the products. Because there is no standard of heavy metals in the category of other processed products in S. Korea, any food products registered as other processed product by manufacturer are free with those standards. Abusing similar problems on the categorization of food products could cause consumers' health problem. To prevent these problems, detail regulations on the categorization of food products have to be introduced.

A Study on the Optimization Methods of Security Risk Analysis and Management (경비위험 분석 및 관리의 최적화 방안에 관한 연구)

  • Lee, Doo-Suck
    • Korean Security Journal
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    • no.10
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    • pp.189-213
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    • 2005
  • Risk management should be controlled systematically by effectively evaluating and suggesting countermeasures against the various risks which are followed by the change of the society and environment. These days, enterprise risk management became a new trend in the field. The first step in risk analysis is to recognize the risk factors, that is to verify the vulnerabilities of loss in the security facilities. The second step is to consider the probability of loss in assessing the risk factors. And the third step is to evaluate the criticality of loss. The security manager will determine the assessment grades and then the risk levels of each risk factor, on the basis of the result of risk analysis which includes the assessment of vulnerability, the provability of loss and the criticality. It is of great importance to put the result of risk analysis in mathematical statement for a scientific approach to risk management. Using the risk levels gained from the risk analysis, the security manager can develop a comprehensive and supplementary security plan. In planning the risk management measures to prepare against and minimize the loss, insurance is one of the best loss-prevention programs. However, insurance in and of itself is no longer able to meet the security challenges faced by major corporations. The security manager have to consider the cost-effectiveness, to suggest the productive risk management alternatives by using the security files which contains every information about the security matters. Also he/she have to reinforce the company regulations on security and safety, and to execute education repeatedly on security and risk management. Risk management makes the most efficient before-the-loss arrangement for and after-the-loss continuation of a business. So it is very much important to suggest a best cost-effective and realistic alternatives for optimizing risk management above all, and this function should by maintained and developed continuously and repeatedly.

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The Content of Heavy Metals in Herbal Pills Used as General Processed Food and Risk Assessment of Heavy Metal Intakes (유통 환(丸)제품의 중금속 함량 및 위해성 평가)

  • Kim, Sung-Dan;Jung, Sun-Ok;Kim, Bog-Soon;Yun, Eun-Sun;Chang, Min-Su;Park, Young-Ae;Lee, Young-Chul;Chae, Young-Zoo;Kim, Min-Young
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.39 no.7
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    • pp.1038-1048
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    • 2010
  • The purpose of this study was to investigate some heavy metals (Pb, Cd, Cr, Cu, Hg) in 52 commercial herbal pills used as general processed food, to identify weekly heavy metal intakes from herbal pills and to evaluate their potential health risks. The samples were digested with a microwave and determinations of heavy metal residues were carried out by inductively coupled plasma mass spectrometry (ICP-MS) and mercury analyzer. The mean values of heavy metal contents for herbal pills used as general processed food were Pb 0.421 (0.032~1.630), Cd 0.157 (0.011~0.515), Cr 1.033 (0.112~9.933), Cu 6.923 (1.333~16.755), Hg 0.010 (0.001~0.088) mg/kg. Lead contents of herba and cadmium of algae, herba were high (ANOVA-test, p<0.05). Levels of cadmium concentrations exceeding WHO reference values (0.3 mg/kg) were observed in 10 samples (4 species). The significant correlation was observed between Pb and Cd (r=0.633, p<0.01). The weekly intakes of Pb, Cd, Cr, Cu, Hg from herbal pills were 1.112 (0.072~5.088), 1.614 (0.029~9.257), 3.000 (0.252~23.690), 0.182 (0.008~1.235), 0.220 (0.000~0.420)%, respectively, as compared with the Provisional Tolerable Weekly Intake (PTWI) established by Joint FAO/WHO Expert Committee for food safety evaluation. Our data suggest regulations limiting heavy metals in herbal pills used as general processed food.

Study on the Fire Risk Prediction Assessment due to Deterioration contact of combustible cables in Underground Common Utility Tunnels (지하공동구내 가연성케이블의 열화접촉으로 인한 화재위험성 예측평가)

  • Ko, Jaesun
    • Journal of the Society of Disaster Information
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    • v.11 no.1
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    • pp.135-147
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    • 2015
  • Recent underground common utility tunnels are underground facilities for jointly accommodating more than 2 kinds of air-conditioning and heating facilities, vacuum dust collector, information processing cables as well as electricity, telecommunications, waterworks, city gas, sewerage system required when citizens live their daily lives and facilities responsible for the central function of the country but it is difficult to cope with fire accidents quickly and hard to enter into common utility tunnels to extinguish a fire due to toxic gases and smoke generated when various cables are burnt. Thus, in the event of a fire, not only the nerve center of the country is paralyzed such as significant property damage and loss of communication etc. but citizen inconveniences are caused. Therefore, noticing that most fires break out by a short circuit due to electrical works and degradation contact due to combustible cables as the main causes of fires in domestic and foreign common utility tunnels fire cases that have occurred so far, the purpose of this paper is to scientifically analyze the behavior of a fire by producing the model of actual common utility tunnels and reproducing the fire. A fire experiment was conducted in a state that line type fixed temperature detector, fire door, connection deluge set and ventilation equipment are installed in underground common utility tunnels and transmission power distribution cables are coated with fire proof paints in a certain section and heating pipes are fire proof covered. As a result, in the case of Type II, the maximum temperature was measured as $932^{\circ}C$ and line type fixed temperature detector displayed the fire location exactly in the receiver at a constant temperature. And transmission power distribution cables painted with fire proof paints in a certain section, the case of Type III, were found not to be fire resistant and fire proof covered heating pipes to be fire resistant for about 30 minutes. Also, fire simulation was carried out by entering fire load during a real fire test and as a result, the maximum temperature is $943^{\circ}C$, almost identical with $932^{\circ}C$ during a real fire test. Therefore, it is considered that fire behaviour can be predicted by conducting fire simulation only with common utility tunnels fire load and result values of heat release rate, height of the smoke layer, concentration of O2, CO, CO2 etc. obtained by simulation are determined to be applied as the values during a real fire experiment. In the future, it is expected that more reliable information on domestic underground common utility tunnels fire accidents can be provided and it will contribute to construction and maintenance repair effectively and systematically by analyzing and accumulating experimental data on domestic underground common utility tunnels fire accidents built in this study and fire cases continuously every year and complementing laws and regulations and administration manuals etc.