利用决策树方法建立转基因植物环境生物安全评价诊断平台

转基因技术及其产品是解决世界粮食问题的重要途径之一, 但是包括食品和环境安全在内的转基因生物安全评价是转基因技术及其产品商品化应用的前提和保证。现有的人为生物安全评价方法存在着一定的不足, 难以应对数量日益增加和内容日趋复杂的转基因产品的安全评价需求, 因此找寻一种客观和高效的评价方法势在必行。决策树(decision tree)方法是现今广泛使用的数据挖掘和分析的决策方法之一, 通过将需要解答问题的层层分解并分别解决, 最终得到理想的决策结果, 在处理复杂问题方面具有独特的优势。本文旨在通过介绍决策树的概念、特性、种类及其构建方法, 探索将决策树方法应用于建立转基因植物环境生物安全评价诊断平台的可行性, 并分析构建的诊断平台在高效、准确和客观地进行转基因植物环境生物安全评价, 以及对新一代转基因产品环境安全性的预测和普及环境安全知识等方面的优势, 为进一步推动转基因技术的发展和转基因产品的安全利用奠定基础。     

总体国家安全观下合成生物学风险和应对策略研究*

合成生物学是近年来兴起的一门兼材料学、医学和信息学等学科特性的交叉学科,在促进医学进步和科技转化应用的同时,也在总体国家安全内涵中被赋予了特殊的重要地位。如何在新时期应对错综复杂的安全形势和严峻挑战,是世界各国和国际社会所面临的科技治理和生物安全的重要命题。重点介绍合成生物技术相关生物武器威胁、生物恐怖威胁、生物安全国际公约条例、生物安全伦理治理框架,总结近年来合成生物技术领域生物安全风险相关问题,提出合成生物学安全风险应对策略和国家总体安全观下科技发展建议。     

对两用生物技术发展现状与生物安全的思考

生命科技的蓬勃发展与全球化步伐的持续加速,为人类社会带来了诸多福祉。然而,生物技术的两用特征和传染病严峻的流行趋势带来了一系列生物安全隐患,引发了世界性的生物安全问题。随着国际形势的日趋复杂,生物安全这一非传统安全问题已成为国家安全体系的重要组成部分。本文通过分析典型两用生物技术的潜在威胁及新发突发传染病的发展趋势,指出我国生物安全领域面临的挑战性问题。同时结合研究发达国家在战略、政策与技术方面应对生物安全的重要举措,从战略布局、科技创新、团队建设、政策支持等方面为我国在两用生物技术的生物安全领域的发展提出建议。     

A semi-quantitative approach to GMO risk-benefit analysis

In many countries there are increasing calls for the benefits of genetically modified organisms (GMOs) to be considered as well as the risks, and for a risk-benefit analysis to form an integral part of GMO regulatory frameworks. This trend represents a shift away from the strict emphasis on risks, which is encapsulated in the Precautionary Principle that forms the basis for the Cartagena Protocol on Biosafety, and which is reflected in the national legislation of many countries. The introduction of risk-benefit analysis of GMOs would be facilitated if clear methodologies were available to support the analysis. Up to now, methodologies for risk-benefit analysis that would be applicable to the introduction of GMOs have not been well defined. This paper describes a relatively simple semi-quantitative methodology that could be easily applied as a decision support tool, giving particular consideration to the needs of regulators in developing countries where there are limited resources and experience. The application of the methodology is demonstrated using the release of an insect resistant maize variety in South Africa as a case study. The applicability of the method in the South African regulatory system is also discussed, as an example of what might be involved in introducing changes into an existing regulatory process.     

Experts against precaution: analyzing the process of biosafety regulation in Iran

The process of preparing and enacting a biosafety law in Iran lasted more than a decade. This paper examines the process of biosafety policy-making in Iran in relation to the Cartagena Protocol on Biosafety (CPB) and to domestic Iranian factors. While some scholars argued that the CPB would be influential in developing countries, our findings indicate that it was not particularly important in Iranian biosafety legislation. This paper outlines the internal Iranian political processes, which initially envisaged a very precautionary approach, but which concluded with a biosafety law designed to promote the adoption of these technologies. Reference will be made to the changing influence of expert biotechnologists on policy-making. The dominance of domestic policy considerations, compared to CPB provisions, implies that signing the CPB does not imply that national regimes will converge on a common model, based on the text of the CPB.     

Experiences from the implementation of a biosafety system in Slovenia

The development and implementation of an effective national biosafety system is important for several key reasons: to ensure safe access to products of modern biotechnology, to build public confidence, to encourage the growth of domestic modern biotechnology, and to comply with international standards and agreements. There is no single best approach in the development and implementation of a national biosafety system and each country is faced with unique challenges. Slovenia is a small country and a new EU Member State. However, it has developed and implemented an efficient national biosafety system. The key elements of this system are administrative procedure, risk assessment, enforcement, and public participation and information.     

The Cartagena Protocol on Biosafety and living modified fish

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.     

我国生物安全科技工作成就与展望

生物安全是国家安全的重要组成部分,科技是国家生物安全的重要战略支撑。针对我国当前面临的重大生物安全威胁,科技部进行了一系列项目部署,不断加强生物安全科技支撑能力建设。本文重点总结了自"十二五"以来我国生物安全科技工作在重大新发突发传染病防控、外来物种入侵甄别与防控、实验室生物安全、生物安全特种资源库建设、基因合成与编辑技术等方面取得的主要成就,展望了前沿生物技术发展与学科交叉融合所带来的新型生物安全风险与防控机遇,并对我国生物安全科技发展提出建议。     

Case studies on the use of biotechnologies and on biosafety provisions in four African countries

This review is based on a study commissioned by the European Commission on the evaluation of scientific, technical and institutional challenges, priorities and bottlenecks for biotechnologies and regional harmonisation of biosafety in Africa. Biotechnology was considered within four domains: agricultural biotechnologies (‘Green’), industrial biotechnologies and biotechnologies for environmental remediation (‘White’), biotechnologies in aquaculture (‘Blue’) and biotechnologies for healthcare (‘Red’). An important consideration was the decline in partnerships between the EU and developing countries because of the original public antipathy to some green biotechnologies, particularly genetically modified organisms (GMOs) and food from GM crops in Europe. The study focus reported here was West Africa (Ghana, Senegal, Mali and Burkina Faso).The overall conclusion was that whereas high-quality research was proceeding in the countries visited, funding is not sustained and there is little evidence of practical application of biotechnology and benefit to farmers and the wider community. Research and development that was being carried out on genetically modified crop varieties was concentrating on improving food security and therefore unlikely to have significant impact on EU markets and consumers. However, there is much non-controversial green biotechnology such as molecular diagnostics for plant and animal disease and marker-assisted selection for breeding that has great potential application. Regarding white biotechnology, it is currently occupying only a very small industrial niche in West Africa, basically in the sole sector of the production of liquid biofuels (i.e., bio-ethanol) from indigenous and locally planted biomass (very often non-food crops). The presence of diffused small-scale fish production is the basis to develop and apply new (Blue) aquaculture technologies and, where the research conditions and the production sector can permit, to increase this type of production and the economy of this depressed areas. However, the problems bound to environmental protection must not be forgotten; priority should be given to monitor the risks of introduction of foreign species. Red biotechnologies potentially bring a vast domain of powerful tools and processes to achieve better human health, most notably improved diagnostics by molecular techniques, better targeting of pathogens and a better knowledge of their sensitivities to drugs to permit better treatment.Biosafety regulatory frameworks had been initiated in several countries, starting with primary biosafety law. However, disparate attitudes to the purpose of biosafety regulation (e.g., fostering informed decision-making versus ‘giving the green-light for a flood of GMOs’) currently prevent a needed consensus for sub-regional harmonisation. To date, most R&D funding has come from North America with some commercial interests from Asia, but African biotechnology workers expressed strong desire for (re-)engagement with interested parties from the European Union. Although in some of the visited countries there are very well qualified personnel in molecular biology and biosafety/regulation, the main message received is that human resources and capacity building in-house are still needed. This could be achieved through home-based courses and capacity-building including funds for post-degree research to motivate and retain trained staff.     

Calling the tunes on transgenic crops: the case for regulatory harmony

Genetically modified (GM) crops are now grown commercially in 23 countries, with another 29 granting approval for import and release into the environment. Despite the socio-economic and environmental benefits of the technology, further development is being hampered by differences in national regulatory frameworks relating to research, biosafety, and to the trade and use of GM crops. The biosafety regulations in different countries are based on five main international instruments that influence the development of national biosafety systems in terms of field trial permit requirements, risk assessment criteria, labeling, traceability, transparency, public awareness, post-monitoring and import regulations. The global harmonization of data collection, testing procedures and information exchange would help to remove artificial trade barriers, expedite the adoption of GM crops, foster technology transfer and protect developing countries from exploitation, instilling confidence and bringing the benefits of GM products to the consumer.     

论《卡塔赫纳生物安全议定书》中与WTO规则冲突的贸易措施

本文介绍了《卡塔赫纳生物安全议定书》的贸易措施 ,以及其与《实施卫生和植物卫生措施协定》、《技术贸易壁垒协定》以及GATT1994等WTO规则的冲突 ,进而指出协调冲突的法律原则和我国的因应之策。     

Agricultural biotechnologies in developing countries and their possible contribution to food security

Latest FAO figures indicate that an estimated 925 million people are undernourished in 2010, representing almost 16% of the population in developing countries. Looking to the future, there are also major challenges ahead from the rapidly changing socio-economic environment (increasing world population and urbanisation, and dietary changes) and climate change. Promoting agriculture in developing countries is the key to achieving food security, and it is essential to act in four ways: to increase investment in agriculture, broaden access to food, improve governance of global trade, and increase productivity while conserving natural resources. To enable the fourth action, the suite of technological options for farmers should be as broad as possible, including agricultural biotechnologies. Agricultural biotechnologies represent a broad range of technologies used in food and agriculture for the genetic improvement of plant varieties and animal populations, characterisation and conservation of genetic resources, diagnosis of plant or animal diseases and other purposes. Discussions about agricultural biotechnology have been dominated by the continuing controversy surrounding genetic modification and its resulting products, genetically modified organisms (GMOs). The polarised debate has led to non-GMO biotechnologies being overshadowed, often hindering their development and application. Extensive documentation from the FAO international technical conference on Agricultural Biotechnologies in Developing Countries (ABDC-10), that took place in Guadalajara, Mexico, on 1-4 March 2010, gave a very good overview of the many ways that different agricultural biotechnologies are being used to increase productivity and conserve natural resources in the crop, livestock, fishery, forestry and agro-industry sectors in developing countries. The conference brought together about 300 policy-makers, scientists and representatives of intergovernmental and international non-governmental organisations, including delegations from 42 FAO Member States. At the end of ABDC-10, the Member States reached a number of key conclusions, agreeing, inter alia, that FAO and other relevant international organisations and donors should significantly increase their efforts to support the strengthening of national capacities in the development and appropriate use of pro-poor agricultural biotechnologies.     

<卡塔赫纳生物安全议定书>及其对转基因农产品国际贸易和生物技术发展的影响与对策

《生物多样性公约》缔约国,为了现代生物技术生产的活性转基因生物（ＬＭＯ）的安全转移和使用,保护人类健康和生物多样性,经过５年的艰苦谈判,于２０００年初通过了《卡塔赫纳生物安全议定书》,成为第一部有关ＬＭＯ的国际法。该《议定书》确认了预先防范原则,允许缔约方禁止或限制ＬＭＯ进境,并要求含有ＬＭＯ的货物附有标签。作者预测了《议定书》对转基因农产品国际贸易和生物技术发展的影响,并对我国应采取的对策提出了     

Biosafety in Populus spp. and other forest trees: from non-native species to taxa derived from traditional breeding and genetic engineering

Forest trees are fundamental components of our environment, mainly due to their long lifetime and important role in forest ecology. In the past, some non-native tree species and taxa from traditional breeding have induced severe environmental impacts such as biological invasion, changes in the ‘gene pool’, and spread of diseases in forestry. Genetically modified trees obtained in different research groups worldwide are particularly confronted with increased concerns regarding biosafety issues. In the light of current biosafety research worldwide, various threats facing forests and natural tree populations are evaluated in this review: biological invasions, horizontal gene transfer, vertical gene transfer and effects on other organisms. Results available from groups working in biosafety research and risk avoidance using forest trees, with emphasis on transgenic trees, are reviewed. Independent biosafety research as well as the establishment of biosafety research programs for forest trees financed by national and international authorities is now more important than ever before. Biosafety problems detected in the past clearly show the importance of a prior case-by-case evaluation of non-native species, new taxa and also genetically modified trees according to the precautionary principle before their release to avoid risks to the environment and human health.     

Agricultural biotechnologies in developing countries and their possible contribution to food security

Latest FAO figures indicate that an estimated 925 million people are undernourished in 2010, representing almost 16% of the population in developing countries. Looking to the future, there are also major challenges ahead from the rapidly changing socio-economic environment (increasing world population and urbanisation, and dietary changes) and climate change.Promoting agriculture in developing countries is the key to achieving food security, and it is essential to act in four ways: to increase investment in agriculture, broaden access to food, improve governance of global trade, and increase productivity while conserving natural resources. To enable the fourth action, the suite of technological options for farmers should be as broad as possible, including agricultural biotechnologies. Agricultural biotechnologies represent a broad range of technologies used in food and agriculture for the genetic improvement of plant varieties and animal populations, characterisation and conservation of genetic resources, diagnosis of plant or animal diseases and other purposes. Discussions about agricultural biotechnology have been dominated by the continuing controversy surrounding genetic modification and its resulting products, genetically modified organisms (GMOs). The polarised debate has led to non-GMO biotechnologies being overshadowed, often hindering their development and application.Extensive documentation from the FAO international technical conference on Agricultural Biotechnologies in Developing Countries (ABDC-10), that took place in Guadalajara, Mexico, on 1–4 March 2010, gave a very good overview of the many ways that different agricultural biotechnologies are being used to increase productivity and conserve natural resources in the crop, livestock, fishery, forestry and agro-industry sectors in developing countries. The conference brought together about 300 policy-makers, scientists and representatives of intergovernmental and international non-governmental organisations, including delegations from 42 FAO Member States. At the end of ABDC-10, the Member States reached a number of key conclusions, agreeing, inter alia, that FAO and other relevant international organisations and donors should significantly increase their efforts to support the strengthening of national capacities in the development and appropriate use of pro-poor agricultural biotechnologies.     

基于DPSEEA模型构建生物安全评价体系：以深圳市为例

由于生物安全内涵外延和基本要素的模糊性、评价指标及评价方法的多元性等因素的限制, 我国至今尚未形成全面有效的生物安全评价指标体系。为构建生物安全评价体系, 研判生物安全现状, 本文首先运用规范分析法剖析《生物安全法》中有关“生物安全”定义的特点及不足, 从国家安全角度认为生物安全是指国家有效防范和应对危险生物因子及相关因素的威胁, 维护和保障自身安全与利益的能力和状态。明晰了生物安全的外延, 即只有对国家安全利益、民众健康、生态环境保护产生威胁的生物风险, 才是生物安全所规制的对象。其次, 生物安全基本要素包括自然生物安全和社会经济生物安全。自然生物安全主要指民众健康和生态环境保护方面, 包括生物个体安全和生物多样性安全。社会经济生物安全的关注点在国家安全利益, 即社会稳定和国家经济利益, 包括生物技术安全、生物实验室安全。第三, 以生物安全基本要素为管理对象的尺度, 将国家安全利益、民众健康和生态环境保护作为评价主体, 以生物法治为理念, 运用模型构建法, 将定性指标和定量指标相结合, 基于驱动力‒压力‒状态‒接触‒影响‒行动模型(driving force-pressure-state-exposure-effect-action, DPSEEA)构建了一套具有生物法治特色的生物安全评价指标体系, 包括生物安全法律法规体系健全水平、生物安全所涉违法犯罪行为的打击力度、生物安全各部门机构协调机制的建立和完善程度、符合规定标准的生物实验室数量和百分比、生物安全人才数量及密度、对生物产业和基本卫生部门的官方援助及其他途径投资总额、疫苗覆盖的目标人群比例、生物安全的宣传教育普及率8项评价指标在内共32项生物安全评价指标。最后, 基于实地调研及数据统计分析, 以2019年和2020年深圳生物安全工作为例对评价体系进行验证。结果显示, 深圳生物安全工作在农业生物安全、动植物防疫、防范外来物种入侵方面成果显著; 但仍在法律法规体系、生物安全人才培养和资金投入、生物安全普及率方面存在不足。针对上述问题提出完善生物安全法律法规体系并注重法律协调衔接、“一个健康”实现多元协同生物治理、加强人才培养和资金投入、加强生物安全宣传教育等建议。     

Next issue (September 2007): Talking Biotech with the Public – including a special FREE podcast!

Edited by Dr. Kristina Sinemus, Darmstadt, Germany Highlight articles: – Public perceptions of biotechnology – Future societal issues in industrial biotechnology – The co-existence debate in Europe – The Co-Extra website – Bioethics, GM crops and intellectual property – Patent scenarios for the future – Experiences in implementation of biosafety systems – Transparent communication strategy on GMOs – Options for a rational dialogue on the acceptance of biotechnology – Attitudes that predict acceptance of genetic engineering in Australia – Biotechnology: the language of multiple views in Maori communities – Science – or not? The scientific status of biotechnology ... and much more: Read the next issue of BTJ!     

Managing Global Atmospheric Change: A U.S. Policy Perspective

There are several air pollution issues that concern the international community at the regional and global level, including acid deposition, heavy metals, persistent organic pollutants, stratospheric ozone depletion, and climate change. Governments at the regional and global levels have entered into various agreements in an effort to deal with these problems. This paper deals with two major global atmospheric change issues: stratospheric ozone depletion and climate change. The focus is on the policy responses of the United States to these global issues. The United States has signed and ratified international agreements to deal with both problems. The Vienna Convention and the Montreal Protocol on Substances that Deplete the Ozone Layer have led to an effort in both developed and developing countries to phase out ozone depleting substances. The United Nations Framework Convention on Climate Change (UNFCCC) has been signed and ratified by over 180 countries. The UNFCC contained no binding targets and timetables for emissions reductions. The Kyoto Protocol (1997) to the UNFCCC did contain targets and timetables for reductions of greenhouse gases on the part of developed countries. The United States has signed but not ratified the Kyoto Protocol. The United States has experienced some movement to reduce greenhouse gas emissions on the part of various levels of government as well as the private sector. The policy process is constantly informed by scientific research. In the case of stratospheric ozone depletion and climate change, much of this work is carried out under the auspices of international scientific panels. From a policy perspective, there is a great deal of interest in the use of indicators for assessing the scope and magnitude of these problems, both for fashioning policy responses as well as assessing the impact of adopted programs to reduce ozone depleting substances, and potentially, greenhouse gases. This paper will discuss some of the indicators used for stratospheric ozone depletion and climate change.     

Regulatory aspects of gene editing in Argentina

Argentina is a world leader in regards to regulation and adoption of genetically modified (GM) crops. As a consequence, the regulatory aspects of gene editing applied to agriculture were considered proactively by the Argentinian regulators, who implemented simple but solid pioneering regulatory criteria for gene edited crops. At present, the Argentine regulatory system is fully able to establish if a gene-edited crop should be classified (and handled) either as a GM crop or a conventional new variety. To this end, the concept of “novel combination of genetic material” derived from the Cartagena Protocol on Biosafety is of decisive importance. After some pilot cases that have been managed under this criteria, now applicants appreciate the ease, speed and predictability of the regulation. Moreover, it has been considered by other countries in the course of developing their own regulations, thus acting also as a harmonization factor for the safe and effective insertion of these technologies in the global market.

     

浅议我国外来物种入侵问题及其防治对策

随着世界经济的发展和全球经济一体化进程的加快,外来物种入侵已成为影响国家安全的主要因素之一。我国外来入侵物种数量繁多,已成为遭受外来生物危害最严重的国家之一,入侵物种已对我国生态系统、环境和社会经济造成了严重的影响。近年来,各国都积极采取措施,制定外来物种入侵管理政策,加强外来物种入侵立法,确保国家及国际生物安全。然而,我国现有的针对外来物种的相关法律法规存在明显滞后。本文综述了我国外来物种入侵的现状及相关立法,指出外来物种入侵可在不同生态系之间发生,揭示了行政区划与生态系差异造成外来物种入侵管理存在"自然与经济的错位"、国内管理方面存在"生态系统与行政区域的错位"的"双错位现象",分析了我国外来物种的管理现状及今后的发展方向,以期探求我国在国际背景下的外来物种管理对策,提出制定《外来入侵物种法》及相关法律的国家体系、建立跨部门协作科学研究体系以及建设行政管理体系,增强抵御外来物种入侵的能力,实施以防为主的管理策略。