生命工學安全性의 國內的 및 國際的 規制動向과 問題點

李載坤(Jae-Gon Lee) 대한국제법학회 2004 國際法學會論叢 Vol.49 No.2

생명공학의 발전을 도모하면서 동시에 생명공학으로 인한 위험에 대한 안전을 확보하기 위한 효과적인 국내적 및 국제적 규제체제를 마련하는 것이 중요하다. 이를 위해 이 논문은 생명공학의 유용성과 인간건강 및 환경에의 위험성, 이러한 위험성에 대응하기 위하여 지금까지 국제사회와 개별국가들이 법적인 측면에서 노력하여 온 경과와 규제내용, 이들 규제방법과 규제들이 안고 있는 문제점, 국내적 규제와 국제적 규제를 통하여 형성 중인 국제규범을 파악하여 보았다. 선진국은 물론이고 개발도상국들도 생명공학안전성을 규제하는 법규를 마련하였거나 마련 중에 있다. 국제적 규제기준들이 구속력없는 문서형태로라도 작성되고 있고 이들을 통하여 각국가의 법규내용이 조화되고 사전주의원칙, 과학적 접근원칙, 사안별 및 단계별 접근원칙, 실질적 동등원칙 및 절차적 원칙과 같은 공통원칙이 형성되는데 영향을 미치고 있다. 많은 문제를 안고 있지만 생명공학안전성의 정서가 채택되어 발효되었고 이것이 각국가의 생명공학안전성법규마련과 집행에 큰 영향을 미칠 것으로 보인다. 생명공학과 유전자변형체의 위험성과 위험정도에 대한 객관적인 평가가 국내적 및 국제적 규제정도와 방법을 정함에 있어 가장 중요한 문제 중의 하나이다. Codex 위원회의 식품분야에 있어서의 기준제시는 다른 분야의 모델이 될 수 있을 것으로 본다. 생명공학안전성의정서당사국총회 또는 UNEP, FAO 및 WHO 등과 같은 관련기구들이 객관적 평가를 수행할 조직을 설립하여 이러한 기능을 수행하도록 할 수 있기를 기대한다. 일부 선진국을 제외한 대부분의 국가들은 생명공학과 유전자변형체의 위험성을 평가하고 관리할 과학적 기반이 없거나 충분하지 못한 것이 현실이다. UNEP-GEF 공동프로젝트에 의하여 법체제 마련을 위한 지원은 어느 정도 이루어지고 있지만 기술적인 측면의 훈련과 지원은 미약하다. 기술지원이 구체화되지 못한다면 마련된 법체제의 실효적 집행에 어려움을 준다. 이 경우 규제가 실현될 수 없는 국가로의 위험유업이 일어나는 것은 쉽게 예상할 수 있고 이 경우 국제적 규제의 실효성은 약화될 것이다. 생명공학안전성의정서의 발효와 함께 의정서당사국총회활동을 통하여 유전자 변형체의 국제적 이동으로 발생하는 책임문제 유전자변형체의 라벨링문제와 같은 기설정 의제의 구체적 해결은 물론 생명공학안전성문제의 종합적 접근과 기준통일을 위한 국제적 논의가 더욱 실효성있게 진행되어야 할 것이다. 개별국가법규간의 일정한 수준의 조화는 미국과 EU간의 분쟁에서 보듯이 국가간 분쟁을 예방하는데 중요한 의미를 가지며 느슨한 규제국가로의 위험이전도 막을 수 있기 때문이다. 생명공학안전성의정서 이외의 국제문서가 구속력을 가지고 있지 못하고 있는 점은 국가들의 구속력있는 조약에 의한 규율이 이루어질 수 있도록 발전시켜야 할 것이다. 국내법규의 발전과정에서 기존 문서의 반영이 이루어지고 있어 조심스럽게 식품분야와 같이 합의될 수 있는 분야부터 시도될 수 있을 것이다. 우리나라 경우는 정책적인 변에서 생명공학의 발전과 안전성확보의 균형이 철저하게 추구되어야 할 필요가 있고 생명공학안전성을 규제하는 법규가 보다 체계적으로 정비되어야 한다. EU의 생명공학안전성 규제법규가 규제정도에 있어서는 우리나라의 생명공학발전정책에 어려움을 줄 수 있겠지만 적어도 규제틀은 모델이 될 수 있을 것으로 보인다. It is important to establish an effective domestic and international regulatory system to secure biosafety with promoting the development of biotechnology simultaneously. This article analyzes 1) various benefits of biotechnology and its risks to human health and the environment, 2) development and contents of practical regulation which individual states and international society have tried to adopt, 3) problems in those regulations and 4) international legal principles which are formulated through domestic and international regulations. Most countries including developing countries have legislated regulatory system or are preparing it. International regulatory standards have been adopting and have promoted the harmonization of domestic biosafety-related legislation and have affected the formation of international legal principles such as precautionary principle, scientific approach principle, step-by step and case by case approach, substantial equivalence principle and procedural principles. The Cartagena Biosafety Protocol was adopted in 2000 and entered into force in 2004 as the first international enforcible norm and are expected to affect the rapid preparation and harmonization of domestic legal system and its enforcement. The objective assessment of the extent of risk of biotechnology and genetically modified organisms(GMOs) is one of the most important elements for the decision of the method and extent of the biosafety regulation. The standard of Codex in the area of GMO foods can be a model for other areas. Contracting Parties of the Biosafety Protocol, UNEP, FAO, WHO, or other international organizations concerned can also establish objective risk assessment and management standards. Most countries still have insufficient scientific infra structures to assess and manage risks arising from biotechnology and GMOs. Even though UNEP-GEF is now providing assistance to prepare legal system through joint projects, training and assistance for the technical aspects has to be strengthened. Without substantial technical assistance, existing regulatory system could not be effectively executed and risks would be easily transferred to less effective risk regulating countries. The effectiveness of international regulation will also be loosened. Contracting Parties of the Biosafety Protocol are expected to discuss not only the problem of responsibility arising from international trade of GMOs and of labeling of GMOs, but also a comprehensive approach to biosafety and international harmonization of regulatory standards. The harmonization of legal systems of individual countries can prevent disputes between countries such as the US-EU GMOs dispute and transfer of risks to less restricted countries. The Korean government has to strike a balance between the development of biotechnology and biosafety. Biosafety-related laws have to be more effectively systemized. The EU regulatory system can be a model at least in terms of regulation mechanism, even though it cannot be a model for the extent of biosafety regulation.

Status of Laboratory Biosafety and Biosecurity in Veterinary Research Facilities in Nigeria

Ismail Ayoade Odetokun,Afusat Toyin Jagun-Jubril,Bernard A. Onoja,Yiltawe Simwal Wungak,Ibrahim Adisa Raufu,Jessica Corron Chen 한국산업안전보건공단 산업안전보건연구원 2017 Safety and health at work Vol.8 No.1

Background: This study determined current status of laboratory biosafety in Nigerian veterinary research facilities. Methods: A questionnaire was developed to obtain information from researchers across Nigeria from July 2014 to July 2015. Information regarding demographics, knowledge of laboratory biosafety, availability and proper use of personal protective equipment (PPE), any priority pathogens researched, attitude on and use of standard laboratory practices, and biosafety awareness was obtained using a numeric scoring system. Data were analyzed with descriptive statistics, and univariate and multivariate logistic regression. Results: A total of 74 participants from 19 facilities completed the questionnaire. General knowledge scores ranged from 3 to 28 (out of 28 possible points), with 94.6% of respondents receiving low scores (scores < mean þ 1 standard deviation). Very few (17.6%) reported availability or use PPE. Many participants (63.5%) reported no access to biosafety level (BSL)-1e3 facilities. None reported availability of a BSL-4 facility. Knowledge scores pertaining to biosafety management practices ranged from 0 to 14 (out of 14 possible points) with 47.3% of respondents receiving good scores (scores > mean þ 1 standard deviation). Only 16.2% of respondents (from four facilities) reported having biosafety officers. Rabies virus was the most researched pathogen (31.1% of respondents). The majority (71.6%) were unaware of laws guiding biosafety. Researchers [odds ratio (OR) ¼ 18.0; 95% confidence interval (CI): 1.63, 198.5; p ¼ 0.023], especially in BSL-2 (OR ¼ 258.5; 95% CI: 12.71, 5256; p < 0.001) facility of research institute (OR ¼ 25.0; 95% CI: 5.18, 120.6; p < 0.001), are more likely to have adequate access to and properly utilize biosafety devices and PPE. Conclusions: Current knowledge of laboratory biosafety is limited except among a few researchers

Biorisk Assessment of Medical Diagnostic Laboratories in Nigeria

Bankole Henry Oladeinde,Richard Omoregie,Ikponmwonsa Odia,Eguagie Osareniro Osakue,Odaro Stanley Imade 한국산업안전보건공단 산업안전보건연구원 2013 Safety and health at work Vol.4 No.2

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 ¼ 0.001), hand washing sink (p ¼ 0.003), and an autoclave (p ? 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.

Biorisk Assessment of Medical Diagnostic Laboratories in Nigeria

Oladeinde, Bankole Henry,Omoregie, Richard,Odia, Ikponmwonsa,Osakue, Eguagie Osareniro,Imade, Odaro Stanley Occupational Safety and Health Research Institute 2013 Safety and health at work Vol.4 No.2

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.

Status of Laboratory Biosafety and Biosecurity in Veterinary Research Facilities in Nigeria

Odetokun, Ismail Ayoade,Jagun-Jubril, Afusat Toyin,Onoja, Bernard A.,Wungak, Yiltawe Simwal,Raufu, Ibrahim Adisa,Chen, Jessica Corron Occupational Safety and Health Research Institute 2017 Safety and health at work Vol.8 No.1

Background: This study determined current status of laboratory biosafety in Nigerian veterinary research facilities. Methods: A questionnaire was developed to obtain information from researchers across Nigeria from July 2014 to July 2015. Information regarding demographics, knowledge of laboratory biosafety, availability and proper use of personal protective equipment (PPE), any priority pathogens researched, attitude on and use of standard laboratory practices, and biosafety awareness was obtained using a numeric scoring system. Data were analyzed with descriptive statistics, and univariate and multivariate logistic regression. Results: A total of 74 participants from 19 facilities completed the questionnaire. General knowledge scores ranged from 3 to 28 (out of 28 possible points), with 94.6% of respondents receiving low scores (scores < mean + 1 standard deviation). Very few (17.6%) reported availability or use PPE. Many participants (63.5%) reported no access to biosafety level (BSL)-1-3 facilities. None reported availability of a BSL-4 facility. Knowledge scores pertaining to biosafety management practices ranged from 0 to 14 (out of 14 possible points) with 47.3% of respondents receiving good scores (scores > mean + 1 standard deviation). Only 16.2% of respondents (from four facilities) reported having biosafety officers. Rabies virus was the most researched pathogen (31.1% of respondents). The majority (71.6%) were unaware of laws guiding biosafety. Researchers [odds ratio (OR) = 18.0; 95% confidence interval (CI): 1.63, 198.5; p = 0.023], especially in BSL-2 (OR = 258.5; 95% CI: 12.71, 5256; p < 0.001) facility of research institute (OR = 25.0; 95% CI: 5.18, 120.6; p < 0.001), are more likely to have adequate access to and properly utilize biosafety devices and PPE. Conclusions: Current knowledge of laboratory biosafety is limited except among a few researchers.

과학기술정보 및 지식의 생산과 흐름분석을 위한 네트워크 분석: 바이오안전성 관련정보의 하이퍼링크를 중심으로

홍형득 한국행정학회 2006 韓國行政學報 Vol.40 No.1

The purpose of this research is to do network analysis on production and flow of science and technology information & knowledge on biosafety. Hyperlink analysis examines Web interactivity, inter-institutional and interpersonal communications, and e-commerce, among other topics. The research is focused on hyperlink of information & knowledge between institutions related biosafety. And we do the centrality analysis among the institutions with adjacent metrics and visualize the network with the network analysis program of UCINET 6 for Window. The results indicate that the production of information and knowledge on biosafety increases drastically after 2004 and public institutions, particularly information service centers lead the flow and production of knowledge and information. In case of central government, they have various network relationship, however, the network are high level of In degree-Centrality. Therefore, they need more endeavor for access to external information. Biosafety Information Center has Out degree -Centrality oriented network toward central government and produces much more information on biosafety. This paper find out that the structure of the hyperlink network on information & knowledge on biosafety in Korea is significantly related to real institutional relationship. 본 연구는 웹공간에서 바이오안전성(Biosafety) 관련 기관간 지식의 생산 및 흐름의 네트워크 분석을 하였다. 기관간 인접도 메트릭스를 이용하여 관련기관들의 중심성 분석을 하고, 네트워크 분석 프로그램(UCINET 6)을 이용하여 연계망을 비주얼화하였다. 본 연구결과 바이오안전성 관련정보와 지식은 2004년후반 이후 생산량이 급격히 증가하고 있으며 주로 공공기관이나 특히 정보센터 등의 정보제공기관 중심으로 이루어지고 있으나 점차 민간기관이나 대학으로 확산되고 있다. 바이오안전성 관련지식의 흐름은 중앙부처들의 경우는 부처간 다양하게 고른 네트워크 관계를 가지고 있으나 내향중심성이 높게 나타나 외부관련정보에 대한 접근노력은 낮은 것으로 보여 진다. 바이오안전성정보센터는 정부부처로의 외향중심성이 높으나 부처들로부터의 내향중심성은 낮은 것으로 나타나 정부부처들의 정책과 정보에 연계노력을 하고 있으며, 가장 많은 정보를 생산하고 있지만 정부부처로부터의 링크는 정보의 생산만큼 받지 못하고 있는 것으로 나타났다. 본 연구결과에서 나타난 것처럼 우리나라 바이오안전성 관련 기관간 정보의 생산 및 흐름의 구조는 웹사이트 사이의 상호연결을 나타내는 하이퍼링크 네트워크 위에 나타나 있는 것으로 보인다.

“책임 및 구제에 관한 추가의정서” 국내 이행 법률(안)에 대한 평가와 전망

김종천 ( Jong Cheon Kim ) 홍익대학교 법학연구소 2015 홍익법학 Vol.16 No.1

The Convention on Biological Diversity (CBD) by the United Nations Environment Programme (UNEP) went into effect in December 1993 with the safety of biological engineering and LMOs (Living Modified Organism) included. The inclusion of the biological engineering and LMOs laid the foundation of the Cartagena Protocol on Biosafety (CPB). Following the move, the second Meeting of the Conference of the Parties to the CBD in Jakarta, Indonesia in 1995 established the Open-ended Ad Hoc Working Group on Biosafety and the extraordinary meeting of the COP to the CBD in Montreal on January 29, 2000 adopted ‘Cartagena Protocol on Biosafety’. The ‘Cartagena Protocol on Biosafety’ of the CBD was finally concluded on January 29, 2000 after five years of discussion. The CPB aims to prevent any hazard occurring from the transboundary movements of LMOs and its possible hazard to the environment and humans. The main features of CPB include AIA (Advanced Informed Agreement), precautionary principle, hazard assessment and management, transport and use, storage, and the operation of biosafety information centre. The CPB sets forth on Article 27 that ‘the COP should adopt a process with respect to the appropriate international rules and procedures in the field of liability and redress for damage resulting from transboudary movements of living modified organisms, and should endeavour to complete this process within four years.’ However, the specific details of such liability and redress with respect to the damage resulting from living modified organisms have not been established. The 5th Conference of the Parties to the Cartagena Protocol on Biosafety on October 2010 adopted Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress. As of June 2014, total 25 states including the EU have entrusted the statement of ratification, acceptance, endorsement or join and up to 40 states are likely to rectify the Supplementary Protocol by October 2014. There are voices demanding the joining of the Supplementary Protocol as the future hosting country of the Cartagena Protocol whereas the opposite side demands that the signing the Supplementary Protocol should be cautious. Those who take the cautious position say that Korea, as the importer of GMOs, should establish the appropriate laws and closely follow the international move before signing in order to conserve biodiversity and to promote public health. This paper has come to the conclusion that we need to establish the legislative bill to implement the ‘Supplementary Protocol on Liability and Redress’ domestically as one of the parties which has been making good practice on the international biosafety. There may be controversy over the bill in terms of whether it should be an independent law or a part of the Act on Transboundary Movements of Living Modified Organisms and Other Related Matters (the LMO Act). The bill should be included in the parent law, the LMO Act, with a provision on definition. Provisions that will be included in the legislative model are the concept on ‘the damage resulting from the living modified organisms (LMO)’, the concept on ‘the victim of the LMOs’, the concept on ‘the person who handles the LMOs (business = operator)’, the provision on ‘the liability in regard of the LMOs’, ‘immunities’, ‘assumption of a causal relationship’, ‘the limit of compensation for the damage caused by the LMOs and the compensation process’, ‘the provision on information’, ‘insurance policy’, and ‘statute of limitations.’ Finally, the proposed bill for the domestic implementation on ‘the Supplementary Protocol on Liability and Redress’ may be not the optimal bill but the starting point of active discussion on the damage caused by the LMOs and the related compensation, which may contribute to the advancement of bioengineering technology, the conservation of biodiversity, and the sustainable use of biodiversity.

시험,연구용 유전자변형생물체(LMO) 안전관리를 위한 안전교육 활성화 방안

노영희 ( Young Hee Rho ),민완기 ( Wan Kee Min ),정규진 ( Gyu Jin Jeong ) 한국안전학회(구 한국산업안전학회) 2014 한국안전학회지 Vol.29 No.2

Biosafety has become quite sensitive issues according to dramatic development of biotechnology and LMO (Living Modifying Organism) is one of the key issue in biosafety. This study is an exploratory research for investigating the activation strategy of biosafety training management in LMO research field. Based on the survey data, main results are derived through various statistical analysis methodology such as descriptive analysis, factor analysis, reliability analysis, analysis of variance and regression analysis. According to the analysis results, some activation strategies are required to reach the target such as extension of specialized biosafety training program, enhancement of safety consciousness from the undergraduate courses, introduction of appropriate safety regulations, unification of safety management and establishment of safety management system.

학술포럼 : 나고야-쿠알라룸푸르 추가의정서 이행을 위한 입법 방안

이세정 ( Se Jeong Yi ) 한남대학교 과학기술법연구소 2011 과학기술법연구 Vol.17 No.2

While living modified organisms (LMOs) promise to benefit the humanity to develop quality foods and new medicines to cure certain diseases, they may pose great risks to both humans and the environment. Therefore, in order to secure safety to use LMOs and to compensate any damage incurred by LMOs, it is required to enact legislative mechanism to protect humans and the environment. At the international level, the Nagoya-Kualalumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety that will lay the foundation for a new system for the liabilities and redress stipulated by Article 27 of the Cartagena Protocol on Biosafety was signed in November 2010. The current LMO Act that is an enforcement act of theCartagena Protocol on Biosafety don`t to define liabilities and redress for any damage incurred by LMOs, and neither do other acts. In order words, Korea has yet to enact a specific law to address such damage. Therefore, Korea should legislate a new law to deal with liabilities and redress for any damage incurred by LMO`s by taking into account the Nagoya-Kualaumpur Supplemantary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety. To this end, this paper propose legislative measures and directions.

나고야-쿠알라룸프 추가의정서 이행을 위한 입법 방안

이순자 ( Soon Ja Lee ) 한국환경법학회 2013 環境法 硏究 Vol.35 No.1

유전자변형생물체(LMO)에 대한 안전성의 문제는 생물다양성의 보존과 지속가능한 이용에 부정적인 효과를 미칠 수 있고, 인체에 대한 영향도 안전하다고 판단하기에는 논란의 여지가 있다. 이에 대해 바이오안전성의정서는 LMO의 잠재적 위해성에 대한 과학적 불확실성에도 불구하고 환경법의 기본원칙 중의 하나인 사전예방 원칙(Precautionary principle)에 입각하여 LMO의 국가간 이동 시 안전을 확보할 수 있는 절차를 규정한 21세기 최초의 국제환경협약이다. 이 협약은 LMO의 국가간이동시 사전통보 승인, LMO의 환경에 미치는 영향 및 위해성 평가와 관리, 위해성 평가 및 심사를 위한 능력배양, 취급ㆍ운송ㆍ포장ㆍ표기 관련사항, 정보공유, LMO의 국가간 이동에 의해 초래될 손해에 대한 책임과 피해배상 등을 주요내용으로 하고 있다. 그 중에서도 LMO로 인해 초래될 손해에 대비해 바이오안전성의정서에서는 당사국들이 유전자변형생물체로 인한 피해 발생시 책임과 복구에 관한 국제적 규범을 만들기 위해 많은 논의를 했고, 그 결과 바이오안전성 카타리나 의정서에 대한 책임과 복구에 관한 나고야-쿠알라룸프 추가의정서(The Nagoya - Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety)를 채택하게 된다. 하지만 추가의정서에서는 대략적인 윤곽 만을 제시하였고 이를 구체화하는 것은 당사국들의 문제로 남게 되었다. 그래서 추가의정서에서 당사국들에게 제시한 책임과 복구에 관한 내용을 국내법으로 제정하기 위한 논의가 필요하여 관련된 내용을 검토하였다. The issue of safety for Living Modified Organisms can negatively influence on the sustainable develpoment and preservation of biodiversity, and is contentious to judge it safe in terms of its influence on human body. Wherefore, The Cartagena Protocol on Biosafety is the first International Convention on Environment in the 21st century that has stipulated the procedure which can secure safety when LMOs transboundary movements on the basis of Precautionary principle, which is one of the principles of environmental law despite the scientific uncertainty as to the potential risk of LMOs, and it mainly covers the prior notification approval at the transboundary movements of LMOs, the influence and risk assessment, management on the environment of LMOs, development of capability over the assessment and screening over risks, matters in relation with the handling, transportation, packaging and identification, information sharing, responsibility and compensation on damages to be caused by the transboundary movements of LMOs. Above all, in preparation of the damage to be caused by LMOs, in accordance with The Cartagena Protocol on Biosafety, the nations concerned have discussed much to establish international norms over Liability and Redress when a damage occurs due to LMOs, and as a result, it makes a decision to adopt The Nagoya ? Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety. However, this Supplementary Protocol has suggested overall outlines, not devising a concrete agenda, and its embodiment was left as a burden on the nations concerned. Therefore, a discussion to enact the text as to the Liability and Redress which the Supplementary Protocol has suggested to the nations concerned is deemed as necessary, and we have reviewed the contents associated.