• Title/Summary/Keyword: biosafety assessment

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

  • Lee, Sang-Gu;Oh, Seon-Woo;Park, Soo-Yun;Park, Hyoun-Min;Kim, Eun-Ha;Jin, So-Ra;Ryu, Tae-Hun
    • Journal of Plant Biotechnology
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    • v.48 no.4
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    • pp.201-206
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    • 2021
  • To ensure the safety of developing or importing genetically modified organisms (GMOs), Korea has enacted the "LMO Act." Accordingly, the safety of using GMOs as food or feed is evaluated in accordance with the concept of "substantial equivalence" proposed by OECD. The allergenicity of GMOs is assessed as a part of their safety evaluation. The methods of allergenicity assessment have been discussed by various international organizations, such as the OECD, FAO, and WHO. The main methods used for the allergenicity assessment of proteins newly expressed in GMOs include assessment of the physicochemical stability of these proteins, evaluation of their amino acid homology with existing allergenic proteins, and serum screening. In this study, we describe guidelines and related studies for the allergenicity assessment of GM crops.

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

  • Yu, Minsu
    • Journal of Environmental Health Sciences
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    • v.40 no.3
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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.

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) (ZGMMV와 CMV 동시 접종을 통한 바이러스 저항성 LM 식물의 잠재적 환경 위해성 연구)

  • Song, Hae-Ryong;Kim, Taesung;Kim, Sun-Jung;Kim, Yong-Hyun;Kim, Ki-Jeong;Chung, Hyen-Mi;Choi, Hee Lak;Yoon, Junheon
    • Journal of Environmental Impact Assessment
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    • v.22 no.2
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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.

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

  • Shin, Haeng-Seop;Yu, Minsu
    • Journal of Environmental Health Sciences
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    • v.41 no.2
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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.

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

  • Kim, Changhwan;Hur, Gyeunghaeng;Lee, Wangeol;Jung, Seongtae
    • Journal of the Korea Institute of Military Science and Technology
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    • v.18 no.3
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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.

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

  • Hwang, Ji Hyun;Hong, Jin Kwan;Ju, Young Duk
    • Korean Journal of Air-Conditioning and Refrigeration Engineering
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    • v.25 no.10
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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.

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

  • Lim, Sun-Hyung;Kim, Na-Young;Lee, Si-Myung;Woo, Hee-Jong;Shin, Kong-Sik;Jin, Yong-Moon;Cho, Hyun-Suk
    • Journal of Plant Biotechnology
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    • v.34 no.4
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    • pp.347-354
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    • 2007
  • Commercialization of genetically modified (GM) plants will be required the assessment of risks associated with the release of GM plants that should include a detailed risk assessment of their impacts in human health and the environment. Prior to GM plant release, applicants should provide the information on GM crops for approval. We carried out this study to provide the molecular data for risk assessment of the GM Chinese cabbage plants with insect-resistance gene, modified CryIAc, which we obtained by Agrobacterium-transformation. From the molecular analysis with GM Chinese cabbage, we confirmed the transgene copy number and stability, the expression of the transgene, and integration region sequences between the transgene and the Chinese cabbage genome. Based on the unique integration DNA sequences, we designed specific primer set to detect GM Chinese cabbage and set up the GM cabbage detection method by qualitative PCR analysis. Qualitative analysis with GM Chinese cabbage progenies analysis was revealed the same as the result of herbicide treatment. Our results provided the molecular data for risk assessment analysis of GM Chinese cabbage and demonstrated that the primer set proposed could be useful to detect GM Chinese cabbage.

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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    • v.4 no.2
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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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    • v.15 no.1
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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.