• Title/Summary/Keyword: safety 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.

The Present State of Domestic Acceptance of Various International Conventions for the Prevention of Marine Pollution (해양오염방지를 위한 각종 국제협약의 국내 수용 현황)

  • Kim, Kwang-Soo
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.12 no.4 s.27
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    • pp.293-300
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    • 2006
  • Domestic laws such as Korea Marine Pollution Prevention Law (KMPPL) which has been mae and amended according to the conclusions and amendments of various international conventions for the prevention a marine pollution such as MARPOL 73/78 were reviewed and compared with the major contents of the relevant international conventions. Alternative measures for legislating new laws or amending existing laws such as KMPPL for the acceptance of major contents of existing international conventions were proposed. Annex VI of MARPOL 73/78 into which the regulations for the prevention of air pollution from ship have been adopted has been recently accepted in KMPPL which should be applied to ships which are the moving sources of air pollution at sea rather tlnn in Korea Air Environment Conservation Law which should be applied to automobiles and industrial installations in land. The major contents of LC 72/95 have been accepted in KMPPL However, a few of substances requiring special care in Annex II of 72LC, a few of items in characteristics and composition for the matter in relation to criteria governing the issue of permits for the dumping of matter at sea in Annex III of 72LC, and a few of items in wastes or other matter that may be considered for dumping in Annex I of 96 Protocol have not been accepted in KMPPL yet. The major contents of OPRC 90 have been accepted in KMPPL. However, oil pollution emergency plans for sea ports and oil handling facilities, and national contingency plan for preparedness and response have not been accepted in KMPPL yet. The waste oil related articles if Basel Convention, which shall regulate and prohibit transboundary movement of hazardous waste, should be accepted in KMPPL in order to prevent the transfer if scrap-purpose tanker ships containing oil/water mixtures and chemicals remained on beard from advanced countries to developing and/or underdeveloped countries. International Convention for the Control if Harmful Anti-Fouling Systems on the Ships should be accepted in KMPPL rather tlnn in Korea Noxious Chemicals Management Law. International Convention for Ship's Ballast Water/Sediment Management should be accepted in KMPPL or by a new law in order to prevent domestic marine ecosystem and costal environment from the invasion of harmful exotic species through the discharge of ship's ballast water.

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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.

On the Novel Concept of "Accident" in the 1999 Montreal Convention -GN v. ZU, CJEU, 2019. 12. 19., C-532/18- (1999년 몬트리올 협약상 "사고"의 새로운 개념에 대한 고찰 - GN v. ZU, CJEU, 2019.12.19., C-532/18 -)

  • An, Ju-Yun
    • The Korean Journal of Air & Space Law and Policy
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    • v.35 no.2
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    • pp.3-40
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    • 2020
  • The term "accident" in the Warsaw Convention of 1929 and the Montreal Convention of 1999, which govern carrier liability in international air transport, is an important criterion for determining carrier liability. However, because there is no explicit definition of the term in the treaty provisions, the term is largely subjected to the judgment and interpretation of the courts. Although there have been numerous changes in purpose and circumstance in the transition from the Warsaw regime to the conclusion of the Montreal Convention, there was no discussion on the concept of "accident" therefore, even after the adoption of the Montreal Convention, there is no doubt that the term is to be interpreted in the same manner as before. On this point, the United States Supreme Court's Air France v. Saks clarified the concept of "accident" and is still cited as an important precedent. Recently, the CJEU, in GN v. ZU, presented a new concept of "accident" introduced in the Montreal Convention: that "reference must be made to the ordinary meaning" in interpreting "accident" and that the term "covers all situations occurring on aboard an aircraft." Furthermore, the CJEU ruled that the term does not include the applicability of "hazards typically associated with aviation," which was controversial in previous cases. Such an interpretation can be reasonably seen as the court's expansion of the concept of "accident," with a focus on "protecting consumer interests," a core tenet of both the Montreal convention and the European Union Regulations(EC: No 889/2002). The CJEU's independent interpretation of "accident" is a departure from the Warsaw Convention and the Saks case, with their focus on "carrier protection," and instead focuses on the "passenger protection" standard of the Montreal Convention. Consequently, this expands both the court's discretion and the carrier's risk management liability. Such an interpretation by the CJEU can be said to be in line with the purpose of the Montreal Convention in terms of "passenger protection." However, there are problems to be considered in tandem with an expanded interpretation of "accident." First, there may be controversy concerning "balance" in that it focused on "passenger protection" in relation to the "equitable balance of interests" between air carriers and passengers, which is the basic purpose of the agreement. Second, huge losses are expected as many airlines fly to countries within the European Union. Third, there is now a gap in the interpretation of "accident" in Europe and the United States, which raises a question on the "unity of rules," another basic tenet of the Convention. Fourth, this interpretation of "accident" by the CJEU raises questions regarding its scope of application, as it only refers to the "hazards typically associated with aviation" and "situations occurring aboard an aircraft." In this case, the CJEU newly proposed a novel criterion for the interpretation of "accident" under the Montreal Convention. As this presents food for thought on the interpretation of "accident," it is necessary to pay close attention to any changes in court rulings in the future. In addition, it suggests that active measures be taken for passenger safety by recognizing air carriers' unlimited liability and conducting systematic reforms.

An Activation Analysis of Target("used H218O") for 18FDG Synthesis (18FDG 생산용 타겟("사용 후 H218O")의 방사화 분석)

  • Kang, Bo Sun
    • Journal of the Korean Society of Radiology
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    • v.7 no.3
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    • pp.213-219
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    • 2013
  • Currently, about 35 cyclotrons have been operating in South Korea. Most of them are mainly used for the synthesis of radiopharmaceuticals such as $^{18}FDG$, which is a cancer tracer for nuclear medicine. Highly enriched $H_2{^{18}}O$ containing up to 98% of $^{18}O/O$ isotope ratio is used as the target for $^{18}F$ production. The price of the highly enriched $H_2{^{18}}O$ ranges 60~70 USD/g, and all of them have been imported from foreign country in spite of the very expensive price. The target (enriched $H_2{^{18}}O$) is non-radioactive before the proton beam irradiation. But, the post-irradiation target (used $H_2{^{18}}O$) must be managed following the National Radiation Safety Regulations, because it turns into radioactive by the radioactivation of the impurities within the target. Recently, nevertheless of the fast increasing amount of used $H_2{^{18}}O$ in accordance with the increasing number of nuclear medicine cases, any activation analysis on the used $H_2{^{18}}O$ have been conducted yet in Korea. In this research, activation analysis have been conducted to confirm the specific radioactivity(Bq/g) of each radioisotopes within the used $H_2{^{18}}O$. The analysis have been done on the 3 of 20g samples collected from the used $H_2{^{18}}O$ storages at different cyclotron centers. Based on the results, it was confirmed that the "used $H_2{^{18}}O$" contains gamma emitters such as $^{56}Co$, $^{57}Co$, $^{58}Co$, and $^{54}Mn$ as well as the considerable amount of beta emitter $^3H$. It was also confirmed that the only one sample contained over exemption level of gamma emitters while the specific activity of tritium was lower than the exemption level in all samples. The specific activity of radioisotopes were measured different levels in the samples depending on the elapsed time after irradiation. Further study on the activation of the "used $H_2{^{18}}O$" is definitely necessary, nevertheless the as-is results of this research must be useful in establishing a rational "used $H_2{^{18}}O$" management protocol.

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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'Open Skies' Agreements and Access to the 'Single' European Sky;Legal and Economic Problems with the European Court of Justice's Judgment in 'Commission v. Germany'(2002) Striking Down the 'Nationality Clause' in the U.S.-German Agreement (항공(航空) 자유화(自由化)와 '단일(單一)' 유럽항공시장(航空市場) 접근(接近);유럽사법재판소(司法裁判所)의 미(美) ${\cdot}$ 독(獨) 항공운수협정(航空運輸協定)상 '국적요건(國籍要件)' 조항(條項)의 공동체법(共同體法)상 '내국민대우(內國民待遇)' 규정 위반(違反) 관련 '집행위원회(執行委員會) 대(對) 독일연방(獨逸聯邦)' 사건 판결(判決)(2002)의 문제점을 중심으로)

  • Park, Hyun-Jin
    • Journal of the Korean Society for Aviation and Aeronautics
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    • v.15 no.1
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    • pp.38-53
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    • 2007
  • In a seminal judgment of November 2002 (Case C-476/98) relating to the compatibility with Community laws of the 'nationality clause' in the 1996 amending protocol to the 1955 U.S.-German Air Services Agreement, the European Court of Justice(ECJ) decided that the provision constituted a measure of an intrinsically discriminatory nature and was thus contrary to the principle of national treatment established under Art. 52 of the EC Treaty. The Court, rejecting bluntly the German government' submissions relying on public policy grounds(Art. 56, EC Treaty), seemed content to declare and rule that the protocol provision requiring a contracting state party to ensure substantial ownership and effective control by its nationals of its designated airlines had violated the requirement of national treatment reserved for other Community Members under the salient Treaty provision. The German counterclaims against the Commission, although tantalizing not only from the perusal of the judgment but from the perspective of international air law, were nonetheless invariably correct and to the point. For such a clause has been justified to defend the 'fundamental interests of society from a serious threat' that may result from granting operating licenses or necessary technical authorizations to an airline company of a third country. Indeed, the nationality clause has been inserted in most of the liberal bilaterals to allow the parties to enforce their own national laws and regulations governing aviation safety and security. Such a clause is not targeted as a device for discriminating against the nationals of any third State. It simply acts as the minimum legal safeguards against aviation risk empowering a party to take legal control of the designated airlines. Unfortunately, the German call for the review of such a foremost objective and rationale underlying the nationality clause landed on the deaf ears of the Court which appeared quite happy not to take stock of the potential implications and consequences in its absence and of the legality under international law of the 'national treatment' requirement of Community laws. Again, while US law limits foreign shareholders to 24.9% of its airlines, the European Community limits non-EC ownership to 49%, precluding any ownership and effective control by foreign nationals of EC airlines, let alone any foreign takeover and merger. Given this, it appears inconsistent and unreasonable for the EC to demand, $vis-{\grave{a}}-vis$ a non-EC third State, national treatment for all of its Member States. The ECJ's decision was also wrongly premised on the precedence of Community laws over international law, and in particular, international air law. It simply is another form of asserting and enforcing de facto extraterritorial application of Community laws to a non-EC third country. Again, the ruling runs counter to an established rule of international law that a treaty does not, as a matter of principle, create either obligations or rights for a third State. Aside from the legal problems, the 'national treatment' may not be economically justified either, in light of the free-rider problem and resulting externalities or inefficiency. On the strength of international law and economics, therefore, airlines of Community Members other than the designated German and U.S. air carriers are neither eligible for traffic rights, nor entitled to operate between or 'free-ride' on the U.S. and German points. All in all and in all fairness, the European Court's ruling was nothing short of an outright condemnation of established rules and principles of international law and international air law. Nor is the national treatment requirement justified by the economic logic of deregulation or liberalization of aviation markets. Nor has the requirement much to do with fair competition and increased efficiency.

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Prospects for development of cosmetic industry using natural products in Chungbuk (충북지역의 천연 자원을 활용한 화장품 산업의 발전 전망)

  • Hwang, Hyung seo
    • Proceedings of the Plant Resources Society of Korea Conference
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    • 2018.10a
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    • pp.26-27
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    • 2018
  • With entry into force of the Nagoya Protocol to promote the fair sharing of the benefits of accessing and utilizing genetic resources, much support has been given to research on the development of biomaterials and products using domestic natural resources. Conservation and resource-saving of native species became very important through Nagoya Protocol enactment. The trend of cosmetic industry has been shifing from use synthetic chemicals to natural biomaterials, due to the safety regulations on new materials, ban on animal experiments, and expansion of cosmeceuticals range. In addition, functional cosmetic range has been expanded from whitening, wrinkle improvement, and ultraviolet shielding, to hair loss, hair loss alleviation, acne relaxation, and moisturizing of atopic skin, thus causing the activation of research about field of efficacy evaluation on natural biomaterials and commercialization. Chungbuk province is fostering the bio industry as a key industry for regional economic growth. For this purpose, Osong Biotechnology Complex/Ochang Science Industrial Complex in middle area, Jecheon biovalley in northern region, and Chungju Enterprise city have been established, thus playing a pivotal role in Bio innovative cluster in Korea. In particular, it was established the osong cosmetics clinical research support center to develop the cosmetics industry in chungbuk, thereby supporting clinical trials, efficacy evaluations, overseas certification, and overseas market entry in order to advance into the global market. In addition, oriental plants such as astragalus propinquus, schisandra chinensis, eucommia, alpiniae oxyphyllae fructus and biancaea sappan are being actively studied as global cosmetic ingredients through the promotion of various national research and development projects using natural materials in chungbuk province. The chungbuk natural product industry is expected to grow further throughout cosmetics industry development in the future, as companies and research institutes are actively promoting the secure index of effective material in natural products and effective material commercialization.

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Research status of the development of genetically modified papaya (Carica papaya L.) and its biosafety assessment (GM 파파야 개발 및 생물안전성 평가 연구 동향)

  • Kim, Ho Bang;Lee, Yi;Kim, Chang-Gi
    • Journal of Plant Biotechnology
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    • v.45 no.3
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    • pp.171-182
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    • 2018
  • Papaya (Carica papaya L.) is one of the crops widely planted in tropical and subtropical areas. The papaya fruit has low calories and are plentiful in vitamins A and C and in minerals. A major problem in papaya production is a plant disease caused by the papaya ringspot virus (PRSV). The first PRSV-resistant GM papaya expressing a PRSV coat protein gene was developed by USA scientists in 1992. The first commercial GM papaya cultivars derived from the event was approved by the US government in 1997. Development of transgenic papayas has been focused on vaccine production and limited agricultural traits, including insect and pathogen resistance, long shelf life, and aluminum and herbicide tolerance. Approximately 17 countries, including the USA and China, produced transgenic papayas and/or commercialized them, which provoked studies on biosafety assessment and development of GM-detection technologies. For the biosafety assessment of potential effects on human health, effects of long-term feeding to model animals have been studied in terms of toxicity and allergenicity. Studies on environmental safety assessment include influence on soil-microbial biodiversity and transfer to soil bacteria of GM selection markers. Many countries, such as Korea, the European Union, and Japan, that have strict regulations for GM crops have serious concerns about unintended introduction of GM cultivars and food commodities using unauthorized GM crops. Transgene- and/or GM event-specific molecular markers and technologies for genomics-based detection of unauthorized GM papaya have been developed and have resulted in the robust detection of GM papayas.

Sick Building Syndrome in 130 Underground Workers (지하상가 근무자의 건강 장애에 관한 실태조사)

  • Joo, Ree;SaKong, Joon;Chung, Jong-Hak;Park, Sang-Whan;Kim, Dong-Hee;Kim, Dong-Min;Choi, Eun-Kyong;Cho, Hyun-Geon
    • Journal of Yeungnam Medical Science
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    • v.15 no.2
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    • pp.325-340
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    • 1998
  • A cross-sectional study was conducted to evaluate the relationship between sick building syndrome(SBS) and the environmental factors affecting SBS on 130 underground workers and 60 controls. The study consisted of 1) a review of environmental condition 2) measurement of temperature, $O_2$, $CO_2$, CO, and formaldehyde and 3) a questionnaire survey of symptom prevalence and perception of environmental conditions using indoor Air Quality questionnaire recommended by National Institute for Occupational Safety and Health. Bronchitis and dust allergy were more prevalent in underground workers significantly(p < 0.05). Among the 18 symptoms related to the indoor air pollution, the experience rate of dry, itching or irritated eyes, sore or dry throat, chest tightness, tired or strained eyes and dry or itchy skin symptom was significantly different between the underground workers and controls. The diagnostic criteria of SBS was defined as at least 1 symptom is experienced 1-3 times a week during the last 1 month among 18 indoor air pollution related symptoms which can be relieved by moving out of the underground. Applying the criteria, the mean symptom score was significant higher in underground workers than controls significantly (p < 0.05). These resalts indicated that underground workers are under inappropriate ergonomic and physical condition and inadequate ventilation. Their experience rate of symptoms related to indoor air pollution and prevalence of SBS was significantly higher than controls. To reduce the prevalence of SBS of underground workers, the surveillance system of indoor air quality, restriction of using fuel in underground and legislative regulations for the environment are needed to establish a better indoor air quality. Early detection, treatment and prevention of SBS through medical attention is also needed.

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