• Title/Summary/Keyword: biosafety assessment

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Status of Policies Relating Biosafety

  • Jang, Hi-min
    • Journal of Plant Biotechnology
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    • v.5 no.1
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    • pp.13-17
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    • 2003
  • Biotechnology is certainly one of the major landmarks in the 20th century history of science. It may produce enormous utility to human beings, but at the same time, it carries huge potential risks to the environment and public health. Thus, with a view to securing safety for the environment and public health in relation to the development and use of living modified organisms (LMOs), the Cartagena Protocol on Biosafety was adopted, in which a regulation Procedure as to the transboundary movements, transportation, handling, and use of LMOs were drawn up. In order to prepare for the entry into force of the Protocol, the Republic of Korea legislated the "Act on the Transboundary Movements of living modified organisms(hereinafter referred as the 'Act')" in Mar 2001, and has pre-announced the enactments of the enforcement ordinance and the enforcement regulation to the Act. Pursuant to the Act, the Ministry of Commerce, Industry and Energy, as a Competent National Authority, is making efforts to implement domestic biosafety schemes in cooperation with other bio-related government ministries. In order for these efforts to reap fruits, industry, academia, and research institutions should cooperate with one another, and civic groups and NGOs should narrow the differences in opinions and timely respond to the fast-changing situations. Focusing on the precautionary principle, the Protocol puts a great emphasis on the importance of information sharing amongst countries, and the Act also follows this principle. In order to gurantee biosafety, countries around the world, including the ROK, agreed to establish National Biosafety Clearing, designed to provide the information on the export/import of LMOs, R'||'&'||'Ds, risk assessment, safety control, etc. and register it on the CBD Central Biosafety Clearing House.e.

Present and Future Perspectives on Exposure Assessment Tools Used to Implement EU REACH (EU REACH 이행에 사용되는 노출평가 툴의 현황과 전망)

  • Sanghun Kim;Dong Hyeon Kim;Eun Kyung Choe;Hyun Pyo Jeon
    • Journal of Environmental Health Sciences
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    • v.50 no.4
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    • pp.237-256
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    • 2024
  • Background: Human health and environment exposure assessments of chemicals are essential part for REACH and BPR as well as K-REACH and K-BPR. Several useful exposure assessment tools have been developed and updated to become extensively used during more than fifteen years of chemical registrations under REACH and their updates are still going on. Objectives: Evolution of regulatory tools for environment, workers and consumers exposure assessments under REACH is investigated focusing on why and how tools have been developed and updated for the future regulatory tools in Korea. Methods: REACH regulatory tools including EUSES, ECETOC TRA and CHESAR as well as built-in models SimpleTreat and SimpleBox were chosen with other frequently used Tier 1 and 2 tools. Available resources such as homepage information, background documents, related scientific reports, relevant journal publications, up-to-date lists of new version publications, release notes and user guides were reviewed extensively and summarized using easy-readable Tables and Figures. Results: SimpleTreat and SimpleBox are built-in models both for EUSES and ECETOC TRA (Environment). ECHA's CHESAR contains ECETOC TRA (Workers) and ECETOC TRA (Consumers) as well as EUSES and ECETOC TRA (Environment) for environment exposure assessment while results of Tier 2 Stoffenmanager and ConsExpoWeb can be imported. Evolution of CHESAR from version 1 (2010) to 3.8 (2023) has focused on the compatibility of frequent updates of IUCLID, importing functionality, editability, updated use maps, harmonised conditions of use as well as updates of the built-in tools evolved according to scientific development, refinements of the tool, increased conservatism and user-friendliness. CHESAR Platform 1.0 will soon be published to serve both for REACH and BPR. Conclusions: Updates of the tools can be successfully continued by transparency of the tools, participation of industry sectors for tool refinements and tool developers'/authorities' encouragements of partners/users to jointly innovate tools through scientific researches, tool validations and user feedback.

Comparative untargeted metabolomic analysis of Korean soybean four varieties (Glycine max (L.) Merr.) based on liquid chromatography mass spectrometry (국내콩 4품종의 LC-MS 기반 비표적대사체 비교평가)

  • Eun-Ha Kim;Soo-Yun Park;Sang-Gu Lee;Hyoun-Min Park;Oh Suk Yu;Yun-Young Kang;Myeong Ji Kim;Jung-Won Jung;Seon-Woo Oh
    • Journal of Applied Biological Chemistry
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    • v.65 no.4
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    • pp.439-446
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    • 2022
  • Soybean is a crop with high-quality of protein and oil, and it is one of the most widely used genetically modified (GM) crops in the world today. In South Korea, Kwangan is the most utilized variety as a parental line for GM soybean development. In this study, untargeted LC-MS metabolomic approaches were used to compare metabolite profiles of Kwangan and three other commercial varieties cultivated in Gunwi and Jeonju in 2020 year. Metabolomic studies revealed that the 4 soybean varieties were distinct based on the partial least squares-discriminant analysis (PLS-DA) score plots; 18 metabolites contributed to variety distinction, including phenylalanine, isoflavones, and fatty acids. All varieties were clearly differentiated by location on the PLS-DA score plot, indicating that the growing environment is also attributable to metabolite variability. In particular, isoflavones and linolenic acid levels in Kwangan were significantly lower and higher, respectively compared to those of the three varieties. It was discussed that it might need to include more diverse conventional varieties as comparators in regard to metabolic characteristics of Kwangan for the assessment of substantial equivalence biogenetically engineered soybeans in a Kwangan-variety background.

Risk Assessment of Genetically Modified Organisms (유전자변형 생물체의 위해성평가)

  • 김형진;김환묵
    • Toxicological Research
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    • v.19 no.1
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    • pp.1-12
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    • 2003
  • New breeding method by genetic engineering is expected as a key technology to solve food shortage due to the growing world population in the year 2000s. Many genetically modified organisms (GMOs) were already developed and the commercial cultivation had started. The first GMO, Flavr Savr tomato, which rotted at a much slower pace than ordinary ones, was developed in US in 1994. Since then, over than 70 different agricultural products including corn, cotton, soybean, papaya, potato, and squash made with genetically modified plants are reportedly on sale worldwide. Supporters favor the GMOs because they have greater yields, longer shelf lives and stronger resistance to disease and insects. On the other hand, opponents say that the supporters ignore a potential danger that they may damage the environment as well as human beings. To assure the safe development and use of GMOs as food and other biotech products, the possible risks on biological environment and human health should be throughly examined and regulated by developer and government. Because the biosafety problem is a global, environmental, and trade issue, a new international treaty is under development. The Cartagena Protocol on Biosafety was adopted at the 1 st Extraordinary Conference of Parties of the Convention on Biological Diversity which was held at Mont-real, Canada, Jan. 29th, 2000. The adoption of the Protocol is seen as a breakthrough in that it is based on the" Precautionary Principle" despite scientific uncertainties surrounding potential risks that GMOs may inflict on human health and the environment and that it has laid the ground for introduction of specific steps to handle international trading of GMOs. In this paper, the authors would like to introduce the current status and perspective of environmental and human risk assessment of GMOs.t of GMOs.

Effects of insect-resistant genetically modified rice (Bt-9) cultivation on non-target insect diversity

  • Oh, Sung-Dug;Lim, Myung-Ho;Lee, Bumkyu;Yun, Doh-Won;Sohn, Soo-In;Chang, Ancheol;Park, Soon Ki;Suh, Sang Jae
    • Korean Journal of Agricultural Science
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    • v.45 no.1
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    • pp.28-37
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    • 2018
  • This study was done to develop environmental risk assessments and a biosafety guide for insect-resistant genetically modified rice at a LMO (Living Modified Organism) isolation field. In the LMO quarantine area of Kyungpook National University, the species diversities and population densities of non-target insects found on insect-resistant genetically modified rice (Bt-9) resistant to Cnaphalocrocis medinalis and on non-GM rices (Dongjin and Ilmi) were investigated. The Bt-9 event was therefore evaluated under field conditions to detect possible impacts on the above ground insects and spiders. The study compared transgenic rice and two non-GM reference rices, Ilmi and Dongjin, at Gunwi in Southern Korea in 2016. Each rice was grown on three $18m^2$ plots with a randomized block design. A total of 4,243 individuals from 43 families and 9 orders were collected from the LMO isolation field. In the three types of rice fields, a total of 1,467 individuals from the insect-resistant genetically modified rice (Bt-9), 1,423 individuals from the Ilmi, and 1,353 individuals from the Dongjin were collected, respectively. There was no difference between the population densities of the non-target insect pests, natural enemies and other insects on the insect-resistant genetically modified rice (Bt-9) and non-GM rices. These results provide the diversity and population density of non-target insects for an environment risk assessment survey on insect-resistant genetically modified rice and could be used as a guideline to make a biosafety assessment method for genetically modified crops.

Influence of insect pollinators on gene transfer from GM to non-GM soybeans (GM 콩의 도입유전자 이동에 미치는 화분 매개충의 영향)

  • Lee, Bumkyu;Kim, Jun Hyeong;Sohn, Soo In;Kweon, Soon Jong;Park, Kee Woong;Chung, Young Soo;Lee, Si Myung
    • Korean Journal of Agricultural Science
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    • v.42 no.3
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    • pp.159-165
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    • 2015
  • The cultivation area and use of genetically modified (GM) crops have been increased continuously over the world and concerns about the potential risks of GM crops are also increasing. One of the major concern in risk assessment is the possible development of hybrids through interspecific and intergeneric crosses with related species. This study was conducted to investigate the pollinator have an influence on insect-mediated gene transfer from GM soybeans. Hybrid was induced from GM soybeans by honeybee and western flower thrips, and non-GM soybeans were used as pollen receptor. The analysis for gene-flow was conducted by herbicide selection, immunostrip test, and PCR analysis. In the result of the analysis, three hybrids were detected on the distance 15, 75, 105 cm from pollen source in western flower thrips treatment. In honeybee treatment, one hybrid was detected in the farthest distance (300 cm). These results suggested honeybee and western flower thrips have a possibility they can transfer the introduced gene from GM soybeans to non-GM soybeans.

Comparison of the nutritional compositions of oxidative stress-tolerant transgenic rice and conventional rice (산화 스트레스 내성 형질전환 벼 현미의 주요 영양성분 분석)

  • Woo, Hee-Jong;Shin, Kong-Sik;Lim, Myung-Ho;Park, Soon Ki
    • Journal of Plant Biotechnology
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    • v.41 no.4
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    • pp.206-211
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    • 2014
  • Nutritional assessment of transgenic crops to improve safety evaluations is important for food production. An oxidative stress-tolerant rice was generated by stable insertion of the TC gene-a tocopherol cyclase isolated from tobacco-into the genome of a common variety of japonica colored rice. The nutritional composition of the brown rice grains from the transgenic TC line was compared with that of the parental rice cultivar Heugnambyeo and two different varieties of non-transgenic rice. The results indicate that the analyzed nutritional compositions of the brown grains from the transgenic TC line were within the range of values reported for other commercial lines, and measurements of nutritional compositions were equivalent to those of the non-transgenic rice.

Current status of comparative compositional analysis for GM crop biosafety assessment (유전자변형작물 안전성평가를 위한 영양성분 비교연구 동향)

  • Kim, Eun-Ha;Oh, Seon-Woo;Lee, Sang-Gu;Lee, Sung-Kon;Ryu, Tae-Hun
    • Journal of Plant Biotechnology
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    • v.47 no.4
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    • pp.261-272
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    • 2020
  • Approvals for cultivation and import of genetically modified (GM) crops have dramatically increased around the world. Comparative compositional studies are an important aspect of safety assessments of products from GM crops and are based on substantial equivalence. Compositional analyses focus on determining similarities and differences between the compositions of the GM crops and their conventional counterparts, and thereby assessing the compositional equivalence of GM crops and their conventional comparators. The analytes, such as major constituents, key nutrients, and antinutrients, are generally determined on a crop-specific basis according to the OECD consensus document. The use of standard methods throughout the processes, such as selection of comparators, field trials, analytical methods, and statistical data analysis, is crucial. In this study, we showed the general framework of compositional studies. Literature for compositional studies of GM crops conducted abroad and in Korea was reviewed to obtain information about analytes, conventional counterparts, cultivation year, location, and statistical methods. The studies conducted abroad assessed for commercial release of GM crops such as soybean, maize, and cotton, while domestic studies were mainly performed for research in rice. In addition, we suggested a guidance for conventional comparators and field trials applicable to the domestic situation.

Development of distinction methods for male-sterile and dwarfism herbicide tolerant Zoysia japonica Steud (웅성불임 및 왜성형질의 제초제저항성 들잔디(zoysia japonica Steud.)의 판별기술 개발)

  • Lee, Bum Kyu;Kang, Hong-Gyu;Ra, Nu Ri;Sun, Hyeon-Jin;Kwon, Yong-Ik;Song, In-Ja;Kim, Chang-Gi;Ryu, Tae-Hun;Park, Kee Woong;Lee, Hyo-Yeon
    • Korean Journal of Agricultural Science
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    • v.41 no.3
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    • pp.187-191
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    • 2014
  • The cultivation area and use of genetically modified (GM) crops have been increased continuously over the world. Concerns about the potential risks of GM crops are also increasing. Safe management for the development and production of GM crops is required according to Living Modified Organism Act in Korea. Planning about the methods, duration, and frequency of environmental monitoring is also required for commercial use of GM crops. GM Zoysia japonica Steud. (event name: JG21) expressing resistance to glufosinate-ammonium has been generated previously. By using gamma ray treatment to JG21 we also developed male sterility and dwarf Z. japonica (event name: JG21-MS). The objective of this study was to establish the monitoring system for environment release of JG21-MS. In this study we extracted RNA from JG21 and JG21-MS and conducted RAPD (random amplified polymorphic DNA) method to distinguish JG21 and JG21-MS.

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.