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The Kingdom of Eswatini is a Party to the Convention on Biological Diversity and to the Cartagena Protocol on Biosafety. As Party, Eswatini has domesticated these agreements by passing the Biosafety Act, of 2012 to provide for the safe handling, transfer, and use of living modified organisms (LMOs) in the country. The Act regulates living modified organisms to be used for confined field trials, commercial release, import, export, and transit, and for food, feed, and processing. Guidance is provided for prospective applicants before any application is made to the Competent Authority. This framework also provides for the regulation of emerging technologies such as synthetic biology and genome editing. The regulatory framework for living modified organisms aims to provide an enabling environment for the precautionary use of modern biotechnology and its products in the country in order to safeguard biological diversity and human health. [ABSTRACT FROM AUTHOR]

The Kingdom of Eswatini is a Party to the Convention on Biological Diversity and to the Cartagena Protocol on Biosafety. As Party, Eswatini has domesticated these agreements by passing the Biosafety Act, of 2012 to provide for the safe handling, transfer, and use of living modified organisms (LMOs) in the country. The Act regulates living modified organisms to be used for confined field trials, commercial release, import, export, and transit, and for food, feed, and processing. Guidance is provided for prospective applicants before any application is made to the Competent Authority. This framework also provides for the regulation of emerging technologies such as synthetic biology and genome editing. The regulatory framework for living modified organisms aims to provide an enabling environment for the precautionary use of modern biotechnology and its products in the country in order to safeguard biological diversity and human health.

Brassica is an essential genus in agriculture, and gene flow from living modified (LM) organisms to native relatives or non-modified cultivars of the crucifer family is a critical issue in Asia. Loop-mediated isothermal amplification (LAMP) is a simple, rapid, and accurate method for identifying LM crops. This study aimed to develop a LAMP assay for the laboratory diagnosis and field analysis of three novel LM canola events: T45, 73496, and MON88302. The genomic DNA of each LM canola was amplified by incubating at 63 °C for 30 min with a newly developed 2 × LAMP premix containing Bst DNA polymerase and event-specific primer sets. The sensitivity of the LAMP assay for the three canola events in our condition ranged from 100 pg·μL−1 to 1 ng·μL−1. Genetic elements of the three LM events were identified through a combination of the LAMP assay, a syringe-type DNA extraction kit, and a portable isothermal amplifier. This study proposes a novel, simple system based on isothermal amplification for the DNA detection of the three LM canola events in a survey field. [ABSTRACT FROM AUTHOR]

The article analyzes the topical issues of international legal regulation of genetic research; it provides a comparative analysis of two groups of international acts regulating relations related to genetic research and application of their results on creation, use and circulation of genetically modified organisms (except humans), on the study of human genome and application of their results. The article deals with the issues of objects and methods of genetic research regulation, balance of interests as the basis for legal regulation of public relations in the field of genomic research. It also considers approaches to ensuring a balance of private, group and common (public) interests. Criticism of certain provisions of the Convention on Human Rights and Biomedicine is given, the question of the inadmissibility of legal opposition between the protection of human rights and the interests of science and society as a whole is raised. The authors put forward proposals on the implementation of a number of international norms in Russian legislation and its further improvement, as well as on the use of blockchain technology in genetic research.

Loop-mediated Isothermal Amplification (LAMP) has been developed to amplify target genes of Living Modified (LM) crops using a simple, rapid, cost-effective, and highly specific process under isothermal conditions. PCR-based detection methods were intensively developed to identify LM crops. However, these methods require expensive laboratory equipment and skilled researchers. This study designed six specific primers for isothermal amplification of LM canola GT73 by Bst DNA polymerase. The reaction condition was simple isothermal amplification in 63°C amplification for 30 min and 80°C inactivation for 2 min. The detection limit of newly developed LAMP assays was approximately 0.8 ng of genomic DNA. To confirm the specificity of the LAMP method, we tested 10 certified reference materials of LM canola, two wild relative species samples (Brassica juncea), and a GT73 canola volunteer. As a result, the LAMP method could specifically detect only the GT73 reference material and GT73 volunteer. We performed LAMP assays using twenty LM canola volunteer samples collected in 2017 in South Korea to verify LAMP specificity. The newly developed LAMP method for GT73 is applicable for LM canola DNA detection. [ABSTRACT FROM AUTHOR]

The primary international forum deliberating the regulation of “synthetic biology” is the Convention on Biological Diversity (CBD), along with its subsidiary agreements concerned with the biosafety of living modified organisms (LMOs; Cartagena Protocol on Biosafety to the CBD), and access and benefit sharing in relation to genetic resources (Nagoya Protocol to the CBD). This discussion has been underway for almost 10 years under the CBD agenda items of “synthetic biology” and “new and emerging issues relating to the conservation and sustainable use of biological diversity,” and more recently within the scope of Cartagena Protocol topics including risk assessment and risk management, and “digital sequence information” jointly with the Nagoya Protocol. There is no internationally accepted definition of “synthetic biology,” with it used as an umbrella term in this forum to capture “new” biotechnologies and “new” applications of established biotechnologies, whether actual or conceptual. The CBD debates are characterized by polarized views on the adequacy of existing regulatory mechanisms for “new” types of LMOs, including the scope of the current regulatory frameworks, and procedures and tools for risk assessment and risk mitigation and/or management. This paper provides an overview of international developments in biotechnology regulation, including the application of the Cartagena Protocol and relevant policy developments, and reviews the development of the synthetic biology debate under the CBD and its Protocols, including the major issues expected in the lead up to and during the 2020 Biodiversity Conference.

基因改造作物對於糧食安全以及生態環境的影響與衝擊目前係一尚無定論的議題。以生物多樣性資源的保育為出發點的「生物安全議定書」（以下簡稱議定書），希望透過事前告知同意程序的制度設計，替締約國在初次引進改性活生物體時，有一套可以依循的程序規範；在相同的國際管制帄台上，為預防外來種所造成對於一國環境生態的衝擊，WTO 也授權各國，依據「食品安全檢驗與動植物防疫檢疫措施協定」（SPS 協定）的規定，可以透過動植物檢疫措施的制訂以保護國內的生態系。兩套的進口管制制度是否相容，牽涉到國際環境公約與WTO 之間的關係與互動的議題，對於一國國內的生態環境以及生物科技發展也有其關聯性，因此，引起不少學者以及實務工作者的討論。本文將嘗詴著由程序面的觀察，討論在進口管制的程序上，比較議定書以及SPS 協定中的程序規範，找出是否可以透過進口管制程序的程序設計來避免兩套管制體系的衝突。此外，由於台灣並非生物安全議定書的締約國，依據議定書的規定，締約國得與非締約國針對改性活生物體的跨境運輸簽訂雙邊、區域性或是多邊的協定，本文也將針對議定書中此一規定，討論台灣在面對談判此等協定時，應採取的立場。 The impact of genetically modified crops on food supply security and on the environment has been an on-going debate. From the viewpoint of biodiversity conservation, the Biosafety Protocol provides procedural-based rules to regulate the first transboundary movement of living modified organisms (LMOs) through a set of advanced informed agreement (AIA) procedures. On the other hand, the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) of the World Trade Organisation (WTO) authorizes its Member to promulgate sanitary and phytosanitary measures to protect the domestic environment. The compatibility of these two sets of import control procedures hinges on the relationship between international environmental agreement and the WTO. The level of import control is also related to how a government plans to balance the interests of protecting its domestic environment and promoting the development of biotechnology. All these issues are highly controversial and attracted keen debate amongst scholars and practitioners. This paper will focus on the procedural design of these two sets of import control system and seek to avoid potential conflict between these two regimes by proposing a set of procedures that can meet the requirements under these two regimes. Meanwhile, the Biosafety Protocol authorizes Parties to conclude bilateral, regional or multilateral agreements with non-Parties concerning the transboundary movement of LMOs. Taiwan is not a Party to the Protocol. This paper, thus, will discuss possible strategies Taiwan may adopt when facing such negotiation.

One of the greatest challenges facing humanity in this century is to achieve sustained world economic growth in a way that ensures protection and conservation of the environment and food security for future generations. Environmental problems have ceased to be a theoretical field in the making and have become a benchmark for real phenomena perceptible by sectors whose various interests are affected. Commerce in safe and healthy food is essential for entrepreneurs, authorities and consumers worldwide. In drafting policies on food, countries must ensure a level of protection for people's health and lives, in addition to safeguarding social and economic interests, whether at the international or national level. In this article, the authors analyze the role of the precautionary principle in the field of biological diversity, with a special emphasis on the regulation of living modified organisms. [ABSTRACT FROM AUTHOR]

The Cartagena Protocol on Biosafety is an international treaty under the Convention on Biological Diversity that promotes biosafety by establishing practical rules and procedures for the safe transfer, handling and use of living modified organisms (LMOs), with a specific focus on regulating transboundary movements of these organisms from one country to another. The Protocol includes the advance informed agreement procedure which sets rules on how Parties should take decisions regarding the transboundary movement of LMOs for intentional introduction into the environment, including living modified fish for biocontrol of non-native and invasive species. The advance informed agreement procedure places great emphasis on risk assessment and the Protocol includes an annex with general principles, methodological steps and points to consider when conducting a risk assessment. In recent years, the Parties to the Protocol have begun to develop guidance on risk assessment for specific types of LMOs although they have not, to date, specifically addressed living modified fish. Other relevant aspects of the Protocol include its provisions on unintentional and illegal transboundary movements; the handling, transport, packaging and identification of LMOs; and liability and redress. [ABSTRACT FROM AUTHOR]

The Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress was finally adopted on 15 October 2010 at Nagoya, Japan. It was negotiated pursuant to a mandate established by the First Conference of the Parties serving as the Meeting of the Parties in 2004 under an enabling provision in the Cartagena Biosafety Protocol. The Supplementary Protocol seeks to deal with damage to biodiversity as well as 'associated' traditional material or personal damage. It delineates two pathways to dealing with such damage: the administrative approach that empowers a competent authority to deal with the matter administratively, without initial recourse to courts; and a civil liability approach that requires litigants to seek private law remedies through national legal systems. However, while the Supplementary Protocol has elaborate and comprehensive provisions implementing the administrative approach, it incorporates only a single article on civil liability which does little more than exhort parties to continue to apply their existing domestic law on the subject or establish rules to deal specifically with the matter. This was not the outcome anticipated when the negotiations started. It was the expectation, primarily of developing countries then, that the prospective protocol would deal essentially with civil liability and set out substantive and procedural rules on liability and redress. This article traces how and why all this came to pass. It also analyses the provisions, and the implications, relating to the administrative approach and the single enabling article on civil liability. It deals also with the challenges in implementing the administrative approach, novel to most countries. Finally, it examines the prospect for the emergence in the future of a more elaborate international civil liability regime. [ABSTRACT FROM AUTHOR]

The inclusion of the socio-economic aspects in environmental decision-making has been practiced since the early seventies. The interactions between the environment and society, the growing demand for social responsibility and the pledge towards sustainable development are some of its drivers. However, in multilateral environmental agreements, particularly in the Cartagena Protocol on Biosafety (CPB), the integration of socio-economic matters in decision-making has been difficult and contentions. Article 26 of the CPB relates to socio-economic considerations arising from the impact of living modified organisms (LMOs) on the conservation and sustainable use of biological diversity. Contrary to the opinion of some scholars and the biotechnology industry, this article argues that Article 26 of the CPB: (a) recognises the sovereign rights of States in taking into account socio-economic considerations when making a decision of import of LMOs; (b) it has a wide scope since it deals with broad issues, namely conservation and sustainable use of biodiversity; and (c) is a cross-cutting article within the CPB since, when included in decision-making, it relates to several operational provisions. Accordingly, the implementation of the CPB would be incomplete and not consistent with its objectives if socio-economic considerations are not appropriately and timely addressed in biosafety decision-making processes. [ABSTRACT FROM AUTHOR]

The ability to obtain reliable information is critical for decision makers. We examined sources of information about plant biotechnology available on the internet to identify credible, high calibre websites. Google-based searches were performed using: 'plant biotechnology', 'plant genetic engineering', 'genetically modified organisms', 'GMO', 'living modified organisms' and 'LMO'. Lists of websites retrieved, frequency of use, and audience varied greatly depending on keyword. Quality of content as assessed by frequency of updates, subject depth, declaration of authorship, indication of source of information, credibility of source, and neutrality, differed significantly among websites. The majority of high quality sites had government, academic, or research affiliations, however these were less frequently retrieved among the top listed websites. To ensure accurate public awareness about plant biotechnology it is important that high quality sites are recommended by information providers, and that they utilise terminology most frequently used by the public. [ABSTRACT FROM AUTHOR]

Concerns have been raised regarding the potential adverse effects on biological diversity of the use of living modified organisms (LMOs, which are commonly known by similar terms such as genetically modified organisms). At the international level these concerns are addressed in part by an agreement known as the Cartagena Protocol on Biosafety and include potential toxic effects of insect-resistant crops on nontarget organisms and potential ecological effects of gene flow from modified crops, fish, microorganisms, or insects to wild species or counterparts. We reviewed the protocol's main provisions, including those dealing with risk assessment and risk management, decision making on imports, documentation accompanying shipments, and liability resulting from damages caused by LMOs. A medium-term program of work has been adopted by the parties, which includes the potential contribution of conservation biologists to delivering capacity building, developing risk assessment guidance, evaluating mechanisms of potential ecological damages from LMOs, and other issues. Conservation biologists and other experts have opportunities to influence the negotiations and implementation of the protocol by providing inputs at meetings, offering expertise to governments and organizations, and participating in or developing relevant projects and initiatives. Involvement of conservation biologists in the implementation and further development of the protocol would contribute to its effectiveness. [ABSTRACT FROM AUTHOR]

Abstract: In Japan, the development and application of living modified organisms (LMOs) are regulated by law (conservation and sustainable use of biological diversity law). Procedures are classed as type 1 for the use of LMOs where no preventive measures against their dispersal into the environment are required and type 2 for the use of LMOs where preventive measures are stipulated. Development and research on transgenic livestock falls under the responsibility of the Ministry of Education, Culture, Science, Sports and Technology. Field use of transgenic livestock is controlled by the Ministry of Agriculture, Forestry and Fisheries. The author describes risk assessment and management of transgenic livestock by both ministries. [Copyright &y& Elsevier]

The primary international forum deliberating the regulation of "synthetic biology" is the Convention on Biological Diversity (CBD), along with its subsidiary agreements concerned with the biosafety of living modified organisms (LMOs; Cartagena Protocol on Biosafety to the CBD), and access and benefit sharing in relation to genetic resources (Nagoya Protocol to the CBD). This discussion has been underway for almost 10 years under the CBD agenda items of "synthetic biology" and "new and emerging issues relating to the conservation and sustainable use of biological diversity," and more recently within the scope of Cartagena Protocol topics including risk assessment and risk management, and "digital sequence information" jointly with the Nagoya Protocol. There is no internationally accepted definition of "synthetic biology," with it used as an umbrella term in this forum to capture "new" biotechnologies and "new" applications of established biotechnologies, whether actual or conceptual. The CBD debates are characterized by polarized views on the adequacy of existing regulatory mechanisms for "new" types of LMOs, including the scope of the current regulatory frameworks, and procedures and tools for risk assessment and risk mitigation and/or management. This paper provides an overview of international developments in biotechnology regulation, including the application of the Cartagena Protocol and relevant policy developments, and reviews the development of the synthetic biology debate under the CBD and its Protocols, including the major issues expected in the lead up to and during the 2020 Biodiversity Conference., (Copyright © 2020 Keiper and Atanassova.)