• 제목/요약/키워드: biosafety assessment

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유전자변형생물체의 알레르기성 평가와 이해 (Allergenicity assessment of novel proteins expressed in genetically modified organisms)

  • 이상구;오선우;박수윤;박현민;김은하;진소라;류태훈
    • Journal of Plant Biotechnology
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    • 제48권4호
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    • pp.201-206
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    • 2021
  • 우리나라는 유전자변형생물체(GMO)의 개발 및 수입 등에 관한 안전성 확보를 위하여 LMO법을 제정하였다. 이에 따라 국내에서 GMO가 식품 및 사료용으로 수입, 생산될 경우는 OECD가 제시한 '실질적 동등성' 개념에 따라 안전성 심사를 한다. 안전성 심사에는 GMO에 대한 알레르기 평가심사가 포함된다. 알레르기성 평가 방법은 OECD, FAO, WHO 등 다양한 국제기구를 통해 논의되어왔다. 주요 알레르기성 평가 방법으로는 GMO에서 새로 발현된 단백질의 물리 화학적 감수성 확인, 기존 알레르기 단백질과의 아미노산 서열 유사성 분석, 혈청 스크리닝 등이 있다. 따라서 본 연구에서는 유전자변형생물체의 알레르기성 평가를 위한 가이드라인과 관련 연구들을 소개하였다.

경영컨설팅 방법론을 이용한 감염병 실험실의 생물안전 위해성평가 조화기준 도출 (Development of a Harmonization Standard for Biosafety Risk Assessment of Infectious Disease Laboratories using Management Consulting Methodology)

  • 유민수
    • 한국환경보건학회지
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    • 제40권3호
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    • pp.187-203
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    • 2014
  • Objectives: As the demand to deal with pathogens in domestic research institutions has expanded and biological accidents have increased, the need for systematic biosafety management in infectious disease laboratories has grown. According to international standards, risk assessment (RA) is required for biosafety management. However, RA criteria have not been clearly established in Korea, so to this end I have attempted to determine RA criteria meeting international levels Methods: In order to provide RA criteria for application, I analyzed the RA criteria in use in the U.S., Europe and at international organizations. In order to ensure the public nature of the RA criteria, I constructed the research model through modified management consulting methodology reflecting the model of Radnor and O'Mahoney. Results: According to the results of the study, existing laboratory biosafety regulations were comparable to domestic laboratory safety laws. Existing laboratory biosafety standards that are designed around risk factors were found to be insufficient. An RA case to be carried out in infectious disease laboratories at the National Institute of Health of KCDC was identified. Conclusion: To establish a systematic risk management system meeting international standards, it was necessary first to harmonize the systems of national and international standards. In addition, in order to provide specific biosafety management on-site, I recognized a need for methodology and planning strategies to discover biosafety management so that it can be carried out as required through the RA of individual laboratories.

ZGMMV와 CMV 동시 접종을 통한 바이러스 저항성 LM 식물의 잠재적 환경 위해성 연구 (Study on potential environmental risk of virus resistant LM plants using co-inoculation of Zucchini green mottle mosaic virus (ZGMMV) and Cucumber mosaic virus (CMV))

  • 송해룡;김태성;김선정;김용현;김기정;정현미;최희락;윤준헌
    • 환경영향평가
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    • 제22권2호
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    • pp.125-134
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    • 2013
  • Plant virus coat (CP) gene-mediated protection is one of the best known approaches to protect against virus resistant transgenic plants. Transgenic N. benthamiana plants containing the CP gene of Zucchini green mottle mosaic virus (ZGMMV) were used for the environmental risk assessment of the living modified (LM) plants with plant virus resistance. The most optimal co-infection method of both ZGMMV and CMV (Cucumber mosaic virus) on Non-LM and CP-expressing LM tobacco plants was established and co-infection of CMV and ZGMMV was confirmed by polymerase chain reaction (PCR). To address the effects of LM tobacco plants on the mutation of the virus, in-vitro transcripts of CP and Replicase (Rep) derived from CMV and/or ZGMMV were inoculated onto Non-LM or LM tobacco plants. Mutation frequency of CP and Rep from CMV and ZGMMV was examined through six serial passages in Non-LM and LM tobacco plants. Little actual frequency of mutation was estimated, probably due to the limited number of transgenic plants tested in this study. However, it does not suggest environmental safety of these CP-mediated LM plants. Further study at a larger scale is needed to evaluate the environmental risk associated with the CP-expressing LM plants.

지식확산에 의한 감염병 실험실의 자율적 생물안전관리 학습조직 설계 및 실행 (Design and Implementation of a Learning Organization for Autonomous Biosafety Management of Infectious Disease Laboratories by Knowledge Translation)

  • 신행섭;유민수
    • 한국환경보건학회지
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    • 제41권2호
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    • pp.102-115
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    • 2015
  • Objectives: A learning organization was designed and implemented on the basis of the selection criteria and essential elements of knowledge translation theory. Methods: The learning organization was designed on the basis of biosafety harmonization criteria and risk management strategy and was implemented as the learning organization for biosafety management by the National Institute of Health, Korea Centers for Disease Control & Prevention. The effect of knowledge translation in the research institutions by evidence-based policy was verified. Results: The result of applying the knowledge translation theory involving all stakeholders showed a positive reaction in establishing and implementing biosafety management strategy and embodied risk assessment criteria and evoked sympathy with the necessity of learning and using of expert knowledge about risk assessment and risk management. All stakeholders initiated voluntarily action toward new human-network construction and communication between similar organizations. The learning organization's capability expanded the base of knowledge translation. Conclusion: These results showed that a learning organization could enhance the autonomous safety management system by diffusion of knowledge translation.

생물안전 3등급 연구시설의 구성 및 이용 (Composition and Use of Biosafety Level 3 Facility)

  • 김창환;허경행;이완걸;정성태
    • 한국군사과학기술학회지
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    • 제18권3호
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    • pp.335-342
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    • 2015
  • Laboratory facilities for biology are designed as biosafety level 1, biosafety level 2, biosafety level 3, and biosafety level 4. Biosafety level designations are based on a composite of the design features, construction, containment facilities, equipment, practice and operation procedures required for working with agents from the various risk groups. Generally, biosafety level 3 means the facility that is appropriate for the experiments using pathogens which can cause serious diseases by aerosol transmission. The biosafety level assigned for the specific work to be done is driven by professional judgement based on a risk assessment, rather than by automatic assignment according to the particular risk group designation of the pathogenic agents to be used. In this paper, we introduced the biosafety level 3 facility operated in ADD(Agency for defense development). It contains the overview of facility, microbiological experiment, animal experiment, decontamination and waste disposal. Biosafety level 3 laboratory in ADD has served the vital role in the research of biological agents and antidote development.

급배기 방식 개선에 따른 생물안전 밀폐시설의 Risk Assessment와 초기 건설비 저감에 대한 연구 (A Study on the Risk Assessment and Reduction of Initial Construction Cost in a Biosafety Laboratory According to Improvement of Supply and Exhaust Method)

  • 황지현;홍진관;주영덕
    • 설비공학논문집
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    • 제25권10호
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    • pp.534-539
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    • 2013
  • In general, entire supply air of the BSL3 laboratory should be vented to the outside for its biosafety and the air conditioning system should always be operating to maintain a room pressure difference. In this regard, annual energy consumption is approximately five or ten times greater than the magnitude of the office building. In addition, to adjust room pressure difference to the set value efficiently, the supply and exhaust duct system are installed in each room of the BSL3 lab. Thus, initial construction cost is extremely high. In this study, multizone simulation is performed to estimate maintaining the appropriate room pressure difference in the case of changing model A (each room supply and exhaust system) to model B (each zone supply and exhaust system) for verification of the BSL3 lab biosafety. Also, in the case of these two models, the multizone simulation for three kinds of biohazard scenario is performed as part of risk assessment. The analysis of initial construction cost of two models is conducted for comparison. According to the studies, initial construction cost of model B is less than about 22% of existing model A. Moreover, biosafety of the BSL3 lab is still maintaining in the case of the two models.

환경위해성 평가를 위한 해충저항성 배추의 분자생물학적 특성 검정 및 계통 특이 마커 캐발 (Molecular Characterization and Event-Specific Marker Development of Insect Resistant Chinese Cabbage for Environmental Risk Assessment)

  • 임선형;김나영;이시명;우희종;신공식;진용문;조현석
    • Journal of Plant Biotechnology
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    • 제34권4호
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    • pp.347-354
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    • 2007
  • 유전자변형 작물의 상업화를 위해서는 유전자변형 작물이 식품으로서의 안전성과 환경에 미치는 영향에 관한 평가가 이루어져야한다. 이를 위해 개발자는 유전자변형 작물의 방출이전에 유전자변형 작물 개발에 관한 정보를 제출해야만 한다. 본 연구는 유전자변형 작물의 환경 위해성 평가를 위한 분자생물학적 자료를 제공하고자 수행하였다. 아그로 박테리움 형질전환법을 통하여 해충저항성 CryIAc 유전자가 도입된 배추 형질전환체를 획득한 후, 분자생물학적인 분석을 통하여 유전자의 copy수, 안정성, 식물체내에서의 발현을 확인하였고, T-DNA의 배추게놈내의 인접서열을 분석하였다. T-DNA의 게놈내 삽입 인접서열을 바탕으로 유전자변형 배추를 동정할 수 있는 프라이머를 제작하였고, 이를 이용한 검정방법을 수립하였다. 계통 특이 프라이머를 이용한 해충저항성 배추 후대의 PCR 분석결과와 제초체 처리결과가 서로 일치하였다. 본 연구 결과로 환경위해성 평가를 위한 해충저항성 배추의 분자생물학적인 자료를 획득하였으며, 개발된 프라이머는 해충저항성 배추의 검출을 위하여 유용하게 사용할 수 있음을 확인하였다.

Biorisk Assessment of Medical Diagnostic Laboratories in Nigeria

  • Oladeinde, Bankole Henry;Omoregie, Richard;Odia, Ikponmwonsa;Osakue, Eguagie Osareniro;Imade, Odaro Stanley
    • Safety and Health at Work
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    • 제4권2호
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    • pp.100-104
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    • 2013
  • Background: The aim of this study was to assess public and private medical diagnostic laboratories in Nigeria for the presence of biosafety equipment, devices, and measures. Methods: A total of 80 diagnostic laboratories in biosafety level 3 were assessed for the presence of biosafety equipment, devices, and compliance rate with biosafety practices. A detailed questionnaire and checklist was used to obtain the relevant information from enlisted laboratories. Results: The results showed the presence of an isolated unit for microbiological work, leak-proof working benches, self-closing doors, emergency exits, fire extinguisher(s), autoclaves, and hand washing sinks in 21.3%, 71.3%, 15.0%, 1.3%, 11.3%, 82.5%, and 67.5%, respectively, of all laboratories surveyed. It was observed that public diagnostic laboratories were significantly more likely to have an isolated unit for microbiological work (p = 0.001), hand washing sink (p = 0.003), and an autoclave ($p{\leq}0.001$) than private ones. Routine use of hand gloves, biosafety cabinet, and a first aid box was observed in 35.0%, 20.0%, and 2.5%, respectively, of all laboratories examined. Written standard operating procedures, biosafety manuals, and biohazard signs on door entrances were observed in 6.3%, 1.3%, and 3.8%, respectively, of all audited laboratories. No biosafety officer(s) or records of previous spills, or injuries and accidents, were observed in all diagnostic laboratories studied. Conclusion: In all laboratories (public and private) surveyed, marked deficiencies were observed in the area of administrative control responsible for implementing biosafety. Increased emphasis on provision of biosafety devices and compliance with standard codes of practices issued by relevant authorities is strongly advocated.

Biosafety Risk Control Strategies in Laboratory Animal Research

  • Shun-tai Weng;Qu-wen Li;Ya-dong Gao;Yu-feng Qiu
    • Safety and Health at Work
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    • 제15권1호
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    • pp.118-122
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    • 2024
  • To understand biosafety's current situation in laboratory animal research and risk factors affecting occupational health. Compliance surveys were conducted by questionnaire via Questionnaire Star (an application app on the Internet) in Chinese. Thirty-nine anonymous questionnaires were collected. The surveyed institution has established 24 types of ABSL (Animal Biosafety Laboratory) and biosafety management organizations and systems equipped with safety equipment. Our study also suggests that the principal of the laboratory establishment fails to perform supervision and inspection responsibilities, the inappropriate design of the animal biosafety laboratory, non-standardized personnel training and health management, non-strict waste management, and insufficient emergency management. The administrative department and work units should address certain safety and occupational health risks in laboratory animal research. The author proposes control strategies based on organizational guarantee, personnel management, emergency management, etc., to help prevent risks and ensure occupational health. Due to regional limitations and small sample size, the results may not be generalisable to all parts of the world. However, some of the key common issuesmay also be present in other regions, sowe believe that this research still has some relevance.