转基因作物风险分析方法研究与安全管理
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摘要
建立全面而可靠的风险识别方法是转基因风险分析的核心内容。由于生物系统的复杂性和受到认知水平、实验规模与时间的限制,目前的方法对转基因作物的风险评估结论往往引起争论。此外,由于外源基因的强化性引入对复杂生态系统中多种群相互作用和时空动态的影响,是目前不能完全依赖实验室条件或通过田间调查的方式验证。因此,对转基因风险理论基础和分析原则的深入理解、对转基因作物风险分析方法的深入研究和创新具有重要意义。
抗除草剂和抗虫是目前商业化转基因作物的主导特性。同时,转基因作物获准进入商业化环境释放之前的科学研究阶段,已不可避免地产生各种潜在的生物风险,却往往被忽视。因此,本研究基于转基因作物特性和研发生产过程中的差异,有针对性地研究了各类转基因作物风险分析的方法,并提出了管理建议。论文共分七章,第一章绪论阐述了论文的选题依据、研究方法和研究内容。第二章讨论了转基因作物风险的理论分析。第三章建立了转基因作物风险分析的全因素层次模型。第四章建立了转基因作物风险分析的元胞自动机模型。第五章建立了转基因作物风险分析的故障树模型。第六章提出了转基因作物风险管理的策略和建议。第七章结论与展望。论文的主要结果包括：
1.建立了转基因抗除草剂作物风险分析的全因素层次模型
结合我国的农业生产实践特点,通过对转基因作物环境释放过程中可能涉及的各种风险因素及其相互作用影响的全面还原和深入分析,建立了一个包含8个子系统的全因素层次模型,识别转基因作物释放到环境的过程中发生的生物、化学、物理和人为因素及其在环境变迁过程中的影响与相互作用1412个,其中可识别的168个风险危害因素中,12类计140个为可确定的风险,28个危害因素可能依赖不同的环境条件或农业实践方式而转变为不利的风险,或不产生风险,为我国转基因抗除草剂作物风险管理决策提供了依据。
2.建立了转基因抗虫作物风险分析的元胞自动机模型
通过对植物-主要害虫-次级害虫-天敌的生态子系统的模拟,建立了一个用于转基因抗虫作物风险分析的带有周期边界的三层随机元胞自动机模型,表征了转基因作物在复杂生态环境中释放的时空动态风险,模拟结果与我国转Bt基因棉花实践中观察到的生态后果相一致,该模型的建立克服了现有转基因风险分析方法不能反映复杂种群的时空动态变化的弊端,拓展了转基因作物风险分析的新思路,为我国转基因抗虫作物的风险管理决策提供了有效的依据。
3.建立了转基因作物实验室风险分析故障树模型
通过对转基因作物实验室阶段的风险分析,构造了一个含有17个中间事件和30个底事件的转基因作物实验室生物风险故障树,通过布尔代数化简法求其最小割集,共得到106组最小割集,根据不同的基本事件在106组割集中出现的频率大小,初步定性地获得各底事件在转基因实验室生物风险事故发生中的结构重要度Iφ(n),并分析了影响转基因作物实验室生物风险故障的主要原因；进一步求得33组转基因作物实验室生物风险故障树的最小径集Pn,通过对求解结果的分析,初步获得控制了转基因作物实验室生物风险的安全措施。
4.比较分析了我国在转基因生物安全管理方面存在的问题,提供了解决的方案与建议。
我国是首批开展转基因作物商业化应用的国家。对转基因作物的风险管理一直采取谨慎的态度,在转基因法规体系和安全评价体系建设方面取得了一定的进展,但也存在急需解决的问题,主要表现在：法规体系不健全；管理体制不完善；管理程序不统一；转基因生物风险分析研究薄弱；对转基因作物农业实践缺乏追溯；公众风险交流有限等。对我国转基因作物风险管理提出以下建议：积极推动转基因安全立法；重视转基因生物风险分析与研究；加强转基因作物风险预防与管理；重视生物多样性保护；完善转基因作物的农业生产保障与管理；加强公众教育和公共参与。
综上,本研究建立的方法体系有助于对转基因作物风险的深入理解和辨识,避免偏见和盲目乐观,有助于推动转基因技术安全健康、可持续地发展。
Risk analysis of transgenic organisms is the most important step to understand their risks and facilitate decision making. Establishment of a comprehensive and reliable risk identification method is the core of risk analysis. However, due to the complexity of biological systems, the cognitive limitatin, deficient of experimental data as well as scale and time constraints, it is still difficult to judge the risk of transgenic crops and the reliability and accuracy of assessment conclusions. In addition, it is not possible currently to rely on laboratory conditions, or through a field survey approach to understand the intensive nature when foreign genes transformed into a variety of complex ecosystems, and the potential temporal and spatial dynamics and the consequences caused by dynamic interactions. Therefore, in-depth understanding of the principles of risk analysis of transgenic crops as well as further research and innovation in estblishment of reliable risk analysis approach are of great significance.
In this paper, a comprehensive review has been addressed on the theoretical basis of risk, the framework, content, principles and common methods of current risk analysis of transgenic crops, and the problems and solutions to a reliable risk analysis methodology have been deeply discussed. Strategies and recommendations have also been provided based on throughfall discussion of various international and national risk management frameworks and policies. The main findings include:
1. Establishment of a hierarchical holographic model for transgenic crops risk analysis.
This study has established a hierarchical holographic model that contains eight sub-systems of an entire ecosystem, which represented the possible interactions and teir effects between/on biological, chemical, physical and human factors and process during environmental release of transgenic crops.1412 interactions were determined, among which 168 risky hazards in 12 categories were indentfied, including 140 determined risks and 28 risk hazards may occur as adverse risks or not depend on environmental conditions or agricultural practices.
2. Establishment of a cellular automaton model based transgenic crops risk analysis method.
In this paper, a simple subsystem contains only four species:crop, target pest, non-target pest and enemy insect, and a three layer arrangement of L×L stochastic cellular automata with a periodic boundary were established. By defining the structure of individual species and their interspecies interactions, and according to the time and space simulation rules, CA simulation showed abundant and sufficient complexity in population assembly and densities, suggesting a prospective application in ecological risk assessment of transgenic crops.
3. Establishment of a fault tree analysis (FTA) model on laboratory biological risks appears in transgenic crops R & D.
This study constructed a fault tree of transgenic crops laboratory biological risks with 17 intermediate events and 30 basal events. Based on the rules of Boolean algebra, a total of 106 least cut sets obtained. According to the occurrence frequency of each basal event in 106 sets, their degree of importance were deduced, which may suggest the causes of biological risks and failures in transgenic crops laboratory; 33 least path sets obtained, and risk control measurements were suggested.
4. Suggestions provided to China's transgenic crops biosafety management
China has chosen a very cautious regulatory system on transgenic crops and the biosafety assessemnt system has made some progress. However, there are still problems need to be resolved, which are:Regulatory system needs to be improved; Management system is incomplete; Management procedures are not unified; Risk analysis of transgenic crops is lagging behind the technological developments and the investment and talents in risk analysis are shortage; Inadequate management in GM crops agricultural practices and lack of tracing; Limited risk communication. The following recommendations have also been provided:To actively promote transgenic safety legislation; Pay more attentions to risk analysis on transgenic crops; Gradually and orderly development and application of transgenic technology based on precautionary principle; Put efforts to biodiversity conservation and the protection of national germplasm resources and food security; Protect the interests of farmers; Strengthen the public education and public participation to achieve better undsertand of transgenic technology and products.
The methods established in this study contributed to an in-depth understanding and recognition of risks related to transgenic crops, which might be helpful to avoid prejudice and blind optimism, and facilitate the development of GM technology, environmental and ecological health and sustainable development.
抗除草剂和抗虫是目前商业化转基因作物的主导特性。同时,转基因作物获准进入商业化环境释放之前的科学研究阶段,已不可避免地产生各种潜在的生物风险,却往往被忽视。因此,本研究基于转基因作物特性和研发生产过程中的差异,有针对性地研究了各类转基因作物风险分析的方法,并提出了管理建议。论文共分七章,第一章绪论阐述了论文的选题依据、研究方法和研究内容。第二章讨论了转基因作物风险的理论分析。第三章建立了转基因作物风险分析的全因素层次模型。第四章建立了转基因作物风险分析的元胞自动机模型。第五章建立了转基因作物风险分析的故障树模型。第六章提出了转基因作物风险管理的策略和建议。第七章结论与展望。论文的主要结果包括：
1.建立了转基因抗除草剂作物风险分析的全因素层次模型
结合我国的农业生产实践特点,通过对转基因作物环境释放过程中可能涉及的各种风险因素及其相互作用影响的全面还原和深入分析,建立了一个包含8个子系统的全因素层次模型,识别转基因作物释放到环境的过程中发生的生物、化学、物理和人为因素及其在环境变迁过程中的影响与相互作用1412个,其中可识别的168个风险危害因素中,12类计140个为可确定的风险,28个危害因素可能依赖不同的环境条件或农业实践方式而转变为不利的风险,或不产生风险,为我国转基因抗除草剂作物风险管理决策提供了依据。
2.建立了转基因抗虫作物风险分析的元胞自动机模型
通过对植物-主要害虫-次级害虫-天敌的生态子系统的模拟,建立了一个用于转基因抗虫作物风险分析的带有周期边界的三层随机元胞自动机模型,表征了转基因作物在复杂生态环境中释放的时空动态风险,模拟结果与我国转Bt基因棉花实践中观察到的生态后果相一致,该模型的建立克服了现有转基因风险分析方法不能反映复杂种群的时空动态变化的弊端,拓展了转基因作物风险分析的新思路,为我国转基因抗虫作物的风险管理决策提供了有效的依据。
3.建立了转基因作物实验室风险分析故障树模型
通过对转基因作物实验室阶段的风险分析,构造了一个含有17个中间事件和30个底事件的转基因作物实验室生物风险故障树,通过布尔代数化简法求其最小割集,共得到106组最小割集,根据不同的基本事件在106组割集中出现的频率大小,初步定性地获得各底事件在转基因实验室生物风险事故发生中的结构重要度Iφ(n),并分析了影响转基因作物实验室生物风险故障的主要原因；进一步求得33组转基因作物实验室生物风险故障树的最小径集Pn,通过对求解结果的分析,初步获得控制了转基因作物实验室生物风险的安全措施。
4.比较分析了我国在转基因生物安全管理方面存在的问题,提供了解决的方案与建议。
我国是首批开展转基因作物商业化应用的国家。对转基因作物的风险管理一直采取谨慎的态度,在转基因法规体系和安全评价体系建设方面取得了一定的进展,但也存在急需解决的问题,主要表现在：法规体系不健全；管理体制不完善；管理程序不统一；转基因生物风险分析研究薄弱；对转基因作物农业实践缺乏追溯；公众风险交流有限等。对我国转基因作物风险管理提出以下建议：积极推动转基因安全立法；重视转基因生物风险分析与研究；加强转基因作物风险预防与管理；重视生物多样性保护；完善转基因作物的农业生产保障与管理；加强公众教育和公共参与。
综上,本研究建立的方法体系有助于对转基因作物风险的深入理解和辨识,避免偏见和盲目乐观,有助于推动转基因技术安全健康、可持续地发展。
Risk analysis of transgenic organisms is the most important step to understand their risks and facilitate decision making. Establishment of a comprehensive and reliable risk identification method is the core of risk analysis. However, due to the complexity of biological systems, the cognitive limitatin, deficient of experimental data as well as scale and time constraints, it is still difficult to judge the risk of transgenic crops and the reliability and accuracy of assessment conclusions. In addition, it is not possible currently to rely on laboratory conditions, or through a field survey approach to understand the intensive nature when foreign genes transformed into a variety of complex ecosystems, and the potential temporal and spatial dynamics and the consequences caused by dynamic interactions. Therefore, in-depth understanding of the principles of risk analysis of transgenic crops as well as further research and innovation in estblishment of reliable risk analysis approach are of great significance.
In this paper, a comprehensive review has been addressed on the theoretical basis of risk, the framework, content, principles and common methods of current risk analysis of transgenic crops, and the problems and solutions to a reliable risk analysis methodology have been deeply discussed. Strategies and recommendations have also been provided based on throughfall discussion of various international and national risk management frameworks and policies. The main findings include:
1. Establishment of a hierarchical holographic model for transgenic crops risk analysis.
This study has established a hierarchical holographic model that contains eight sub-systems of an entire ecosystem, which represented the possible interactions and teir effects between/on biological, chemical, physical and human factors and process during environmental release of transgenic crops.1412 interactions were determined, among which 168 risky hazards in 12 categories were indentfied, including 140 determined risks and 28 risk hazards may occur as adverse risks or not depend on environmental conditions or agricultural practices.
2. Establishment of a cellular automaton model based transgenic crops risk analysis method.
In this paper, a simple subsystem contains only four species:crop, target pest, non-target pest and enemy insect, and a three layer arrangement of L×L stochastic cellular automata with a periodic boundary were established. By defining the structure of individual species and their interspecies interactions, and according to the time and space simulation rules, CA simulation showed abundant and sufficient complexity in population assembly and densities, suggesting a prospective application in ecological risk assessment of transgenic crops.
3. Establishment of a fault tree analysis (FTA) model on laboratory biological risks appears in transgenic crops R & D.
This study constructed a fault tree of transgenic crops laboratory biological risks with 17 intermediate events and 30 basal events. Based on the rules of Boolean algebra, a total of 106 least cut sets obtained. According to the occurrence frequency of each basal event in 106 sets, their degree of importance were deduced, which may suggest the causes of biological risks and failures in transgenic crops laboratory; 33 least path sets obtained, and risk control measurements were suggested.
4. Suggestions provided to China's transgenic crops biosafety management
China has chosen a very cautious regulatory system on transgenic crops and the biosafety assessemnt system has made some progress. However, there are still problems need to be resolved, which are:Regulatory system needs to be improved; Management system is incomplete; Management procedures are not unified; Risk analysis of transgenic crops is lagging behind the technological developments and the investment and talents in risk analysis are shortage; Inadequate management in GM crops agricultural practices and lack of tracing; Limited risk communication. The following recommendations have also been provided:To actively promote transgenic safety legislation; Pay more attentions to risk analysis on transgenic crops; Gradually and orderly development and application of transgenic technology based on precautionary principle; Put efforts to biodiversity conservation and the protection of national germplasm resources and food security; Protect the interests of farmers; Strengthen the public education and public participation to achieve better undsertand of transgenic technology and products.
The methods established in this study contributed to an in-depth understanding and recognition of risks related to transgenic crops, which might be helpful to avoid prejudice and blind optimism, and facilitate the development of GM technology, environmental and ecological health and sustainable development.
引文
5http://www.gov.cn/jrzg/2006-02/09/content_183787.htm
9 http://www.stee.agri.gov.cn/biosafety/spxx/t20051107_488946.htm
10进口大豆威胁非转基因基地的生存http://www.cnyouzhi.com/html/Articles/20090701/45783_1.html
11基因是与非：中国非转基因大豆争夺话语权http://jr.voc.com.cn/listId.asp?GClass=&FId=12876&page=2
12 农业部农业转基因生物安全管理办公室http://www.stee.agri.gov.cn/biosafety
13 The Royal Society, Review of data on possible toxicity of GM potatoes. http://www.royalsoc.ac.uk/files statfiles/document-29.pdf
14 http://www.sciencenet.cn/html/showsbnewsl.aspx?id=184535
15 http://www.monsanto.com/pdf/products/yieldgard_rw_response.pdf
16 欧盟专家重申MON863转基因玉米无害http://www.sciencenet.cn/html/shownews.aspx?id=184512
17 http://www.monsanto.com/pdf/science/response_to_austrian_gm_study_20nov08.pdf
18 http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902199210.htm
19 Food and Ag Biotech (BIO) Press Release, EPA report finds biotech crops have little impact on monarch butterflies. http://www.biotech-info.net/butterfly_PR.html, October 19,2000.
20 王海平.转基因棉引发减产之忧，21世纪经济报道http://www.21cbh.com/HTML/2009-9-30/148758.htrnl
21http://www.greenpeace.org/china/zh/news/20050803_GE_Rice_in_Carrefour
22 http://www.greenpeace.org/china/zh/press/reports/ge-rice-foreign
23 http://www.greenpeace.org/china/zh/press/reports/3045095
24 MacArthur M. Triple-resistant canola weeds found in Alberta.2000. http://www.producer.com/articles/20000210/ news/20000210 news01.html.
25 Thomas P. Outcrossing between canola varieties-a volunteer canola control issue. http://www.agric.gov.ab.ca/ crops/canola/outcrossing.html
26 详见环境保护部.中国生物多样性履约简报,2004年第一期,http://cpsc.sepa.gov.cn/natu/swdyx/jianbao/ 200405/t20040522_90406.htm
33 US EPA (2001) Biopesticides Registration Action Document-Bacillus thuringiensis Plant Incorporated Protectants: http://www.epa.gov/oppbppdl/biopesticides/pips/bt_brad.htm
35 http://www.stee.agri.gov.cn/biosafety/spxx/t20091022_819214.htm
36 http://www.stee.agri.gov.cn/biosafety/zcfg/xztz/t20060530_619732.htm
48 http://www.ccaa.org.cn/cnca/zwxx/xwdt/zxtz/images/20080310/3874.pdf
50 http://www.cbd.int/biosafety/about.shtml
51 http://www.cbd.int/biosafety/parties/list.shtml
52 http://www.biosafetyprotocol.be/UNEPGuid/Contents.html
53 http://www.biosafety.be/PDF/2001_18.pdf
54 Directive 90/219/EEC on the contained use of genetically modified micro-organisms:http://europa. eu.int/eur-lex/lex/LexUriServ/LexUriServ.do?uri=CELEX:31990L0219:EN:HTML
55 http://www.biosafety.be/GB/Dir.Eur.GB/Del.Rel./2001_18/2001_18_A2.html
56http://www.cfsan.fda.gov/wlrd/consulpr.html
57 http://www.cfsan.fda.gov/world/biocon.html
58 FIFRA:http://www.epa.gov/opp00001/regulating/fifra.pdf
59 http://www.aphis.usda.gov/brs/pdf/PlantProtAct2000.pdf
60 http://www.hc-sc.gc.ca/fn-an/legislation/acts-lois/fdr-rad/division-titre28_e.html
61 http://www.ogtr. gov.au/pubform/legislation.htm
62 http://www.stee.agri.gov.cn/biosafety/spxx/
63 http://www.stee.agri.gov.cn/biosafety/spxx/t20051107_488946.htm
64 其中2003年7项,2006年5项,2007年14项,2008年27项,2009年3项。详见http://www.stee.agri.gov.cn/ biosafety/jsbz/
65 http://www.stee.agri.gov.cn/biosafety/jyjg/t20051107_488723.htm
66 http://www.sciencenet.cn/htmlnews/2008/7/208944.html
13 见绿色和平调查报告《非法转基因水稻污染中国大米》,http://www.greenpeace.org/china/zh/press/reports/ 119222
68http://news.xinhuanet.com/ziliao/2003-07/01/content_947945_1.htm
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51 http://www.cbd.int/biosafety/parties/list.shtml
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