转基因作物生物安全性评价与监管体系的分析与对策
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摘要
目前国内外大面积种植的转基因作物主要是以抗虫和耐除草剂性状为主的第一代转基因作物。国内外对第一代转基因作物的安全性评价与监管都出台了一系列政策与法规。国际上转基因作物的新发展趋势是:复合性状、营养改良与药用等新一代转基因作物不断涌现。国际上许多国家已经制订了一系列针对新一代转基因作物安全性评价与监管的政策与法规,而我国政府还没有出台新一代转基因作物安全性评价与监管的法规。
本研究目的:(1)系统全面分析国内外对第一代转基因作物,主要是抗虫与耐除草剂作物安全评价法规与监管模式比较的基础上,分析我国转基因作物评价与监管中取得的成就、存在的问题与建议;(2)调研分析国外对新一代转基因作物:复合性状、营养改良与药用转基因作物安全性评价与监管措施,提出我国对新一代转基因作物安全性评价内容与监管措施,供决策部门参考。
本文主体研究成果如下:
1.通过对转基因作物安全性评价的原则、内容和方法以及国内外转基因作物评价与监管模式的比较分析,归纳了我国转基因作物安全性评价和监管中取得的成就:
(1)中国是发展中国家最早建立农业转基因生物安全性评价与监管条例的国家,并率先开展了转基因抗虫棉的产业化。
(2)有效地保障了我国转基因抗虫棉研究、开发与产业化,取得了巨大的环境、经济与社会效益,挽救了我国的棉花纺织产业。
(3)抗虫棉环境安全研究开创了监管新模式,在转基因棉花商业化生产监管中实行“天然庇护所”策略,控制了棉铃虫对转基因抗虫棉产生抗性。转基因抗虫棉的连续11年产业化历程证明这种策略的正确性。
(4)逐步建立和完善了农业转基因作物及其产品的检测机构及检测标准(体系),农业部筹建了下属21个转基因生物及其产品检测中心,并且已经逐步通过认证或正在进行认证;建立和发布了37项转基因生物及产品环境安全与食品安全的检测标准。
(5)保障了转基因生物对人类与环境的安全,事实证明,经农业部经过严格的安全性评价批准进入市场的转基因作物及其产品以及批准进口作为食品与饲料加工原料的产品都是安全的。
2.通过分析比对国内外转基因作物安全性评价内容与方法,指出了我国转基因作物评价和监管中存在着三大问题,针对这些问题及安全性评价中争论性问题,提出自己的建议:
(1)对于现行的以品种为基础的转基因作物商业化种植安全性评价与监管模式,建议采用国际上通用的以转化体事件为基础的评价与监管;
(2)对于按照省份逐个申请转基因作物安全证书的问题,建议实行分生态区种植的监管模式;建议全国一证制;
(3)对转基因作物及其产品强制性与零阈值标识问题,建议采用自愿标识政策;
(4)对于转基因作物安全性评价中出现的一些有争论事件建议:不应过分强调转基因作物的非预期效应;卡那霉素标记基因可以在转基因作物中继续使用;如果转基因作物与其非转基因对照实质等同,就没有必要进行动物试验。
3.本文通过分析新一代转基因作物--复合性状转基因作物的发展趋势、可能存在的风险以及各国对育种复合性状转基因作物的评价内容和方法,归纳了国际上对复合转基因作物进行安全性评价的三种主要模式:(1)美国加拿大模式;(2)日本与韩国模式;(3)欧盟模式。建议我国对育种复合性状转基因作物借鉴美国的管理模式,实行简单评价程序。
4.通过分析国外对高赖氨酸玉米和富含维生素A金米的安全性评价个案分析,提出对新一代转基因营养改良作物安全性评价的内容和方法:外源蛋白安全性评价要全面;应该对预期改变营养成分的代谢产物进行评价;要着重评价其目标营养成分改变的安全性,以及营养改变转基因作物的营养功效。
5.通过比较分析国际上对未来新一代转基因作物,尤其是药用转基因作物风险评价与管理对策研究,提出我国对未来药用转基因作物评价与监管的建议:完善药用转基因作物评价规定;对预期使用的评价要以其他生物反应器为对照进行评价;对食用安全与环境安全评价要以其非转基因对照比较;设计产品生产过程中无活性,加工工程中激活;利用遗传限制技术使药用植物花粉不育等。
这些建议供我国农业转基因安全性评价与监管决策部门制订新一代转基因作物安全性评价和监管措施时提供重要的科学参考。
The current large scale commercialization biotech crops are belong to the first generation of biotech crops—insect resistant and herbicide tolerant biotech crops. A serials of policies and regulations for biosafety assessment and monitoring measurements for the first generation of biotech crops have been published by the international organizations, foreign countries, as well as the Chinese government. With the rapid development of second generation of biotech crops globally, many countries and international communities have published their policies and regulations regarding to the biosafety assessment and monitoring measurements for these new biotech crops. However, the Chinese government did not publish any new policy or regulation yet regarding to the new generation of biotech crops. Therefore, it is very significant to study the biosafety assessment method to the new generation of biotech crops.
The objectives of this study are: (1) analyzing and comparing the worldwide policies and regulations on biosafety assessment and monitoring system to the first generation of biotech crops, conclude the achievements and problems in biosafety assessment and monitoring system of China, and provide suggestions to solve the problems existed; (2) investigate and analyzing the international commercial development, biosafety assessment and monitoring measurements of new generation of biotech crops: stack trait and nutritional improved biotech crops and PMPs, provide suggestions to the biosafety assessment method and monitoring measurements to the Chinese government. The main research achievements of this study are as follows:
1. Trough the comparison of biosafety assessment principles, contents, methodology and monitoring of biotech crops, the author has evaluated the achievements of biosafety assessment and monitoring of biotech crops in China:
(1) China is the first country in the developing world to established the biosafety assessment and monitoring regulation system to biotech crops, and commercialized Bt cotton as early as 1997;
(2) China effectively protected and promoted the research, development and commercialization of Bt cotton, great achievements have been made on the environmental , economic and social benefits, the commercialization of Bt cotton has saved the textile industry in China;
(3) New model of Bt cotton’s field management has been innovated, the“natural refuge”strategy has been demonstrated is a successful model to control the insect resistance to the Bt cotton under the field condition since the Bt cotton has been sustainable commercialization for 11 years in China;
(4) The detection system and detection standardization system of biotech crops and their products have been established and perfected step by step: 21 detection centers for GM organisms and their products have been in preparation and some of them have completed the certifying process. In addition, 37 national detection standards for GMOs environmental safety and food safety have been developed and published.
(5) The human health safety and environmental safety of GMOs have been protected. It has been demonstrated that all products include imported products as food/feed processing material or products for cultivation, which approved by MOA, are safe.
2. The study also pointed out the problems existed in the current biosafety assessment and monitoring system of biotech crop and their products in China, and further improvement suggestions have been provided:
a) For the current variety based regulation for the cultivation purpose, the author has suggested that an event based regulation, which is adopted by most of the countries, should be implemented;
b) Regarding to the safety certificate for commercial cultivation of new biotech crops by individual province, the author has suggested that a safety certificate for the whole country should be adopted except some special environment safety concerns (wild species of sexually cross pollinated varieties). The field monitoring system by ecological zone would be more reasonable.
c) To the issue of mandated labeling and zero threshold of 5 biotech crops and 17 biotech products, the author recommended that a volunteer labeling system should be adopted.
d) Regarding to some biosafety debate, the author has suggested that: the unintended effect of should not be overemphasized in the biosafety assessment process of biotech crop and their products; there is scientific evidence shows that the NPTII selectable marker for kanamycin resistance is a safe marker, and it can be used for the biotech crops; there is no need to conduct the animal trial if the gene donor has a safe food use history and the transgenic food is substantial equievlent to the non-transgenic food;
e) The commercialization has become the main restriction factor to the development of agricultural biotechnology, the author suggest the government should re-evaluate the benefit and risk of biotech crops, promote the commercialization of biotech rice and corn.
3. Through the study of biosafety assessment and monitoring of second generation of transgenic crops: the future development of stack trait biotech crops and the biosafety assessment content and methodology to the stack trait biotech crops from different countries, the author has concluded that there are 3 models to manage the breeding stack trait crops: (1) US and Canada model; (2) Japan and Korea model and (3) EU model. The author has suggested that China should take a position to simplify the assessment by providing bridge data for breeding stacks.
4. Through the evaluation of biosafety assessment to new generation of biotech crops with improved nutrition---high lysine corn and enriched Vitamin A rice, so-called golden rice, recommended by ILSI, the author has suggested the assessment pattern to nutrition improved biotech crops and their products: the assessment of expressed protein should be comprehensive; evaluate the metabolic products of target nutrients; focus on the nutrition composition analysis and nutrition efficacy evaluation.
5. Through the comparison and study of risk issue and monitoring measurements of second generation of biotech crops, the author provided the risk management and monitoring measurements to PMPs: develop the regulation to safety assessment of PMPs; set other bioreactor as control when evaluate the intended use; set the non-transgenic iso-line as control when evaluate the food and environment safety; design the product without activity during production of PMPs; using GURT to prevent the gene flow.
These recommendations and suggestions have provided very important background information for policy makers to draft the regulations to future biotech crops and products.
本研究目的:(1)系统全面分析国内外对第一代转基因作物,主要是抗虫与耐除草剂作物安全评价法规与监管模式比较的基础上,分析我国转基因作物评价与监管中取得的成就、存在的问题与建议;(2)调研分析国外对新一代转基因作物:复合性状、营养改良与药用转基因作物安全性评价与监管措施,提出我国对新一代转基因作物安全性评价内容与监管措施,供决策部门参考。
本文主体研究成果如下:
1.通过对转基因作物安全性评价的原则、内容和方法以及国内外转基因作物评价与监管模式的比较分析,归纳了我国转基因作物安全性评价和监管中取得的成就:
(1)中国是发展中国家最早建立农业转基因生物安全性评价与监管条例的国家,并率先开展了转基因抗虫棉的产业化。
(2)有效地保障了我国转基因抗虫棉研究、开发与产业化,取得了巨大的环境、经济与社会效益,挽救了我国的棉花纺织产业。
(3)抗虫棉环境安全研究开创了监管新模式,在转基因棉花商业化生产监管中实行“天然庇护所”策略,控制了棉铃虫对转基因抗虫棉产生抗性。转基因抗虫棉的连续11年产业化历程证明这种策略的正确性。
(4)逐步建立和完善了农业转基因作物及其产品的检测机构及检测标准(体系),农业部筹建了下属21个转基因生物及其产品检测中心,并且已经逐步通过认证或正在进行认证;建立和发布了37项转基因生物及产品环境安全与食品安全的检测标准。
(5)保障了转基因生物对人类与环境的安全,事实证明,经农业部经过严格的安全性评价批准进入市场的转基因作物及其产品以及批准进口作为食品与饲料加工原料的产品都是安全的。
2.通过分析比对国内外转基因作物安全性评价内容与方法,指出了我国转基因作物评价和监管中存在着三大问题,针对这些问题及安全性评价中争论性问题,提出自己的建议:
(1)对于现行的以品种为基础的转基因作物商业化种植安全性评价与监管模式,建议采用国际上通用的以转化体事件为基础的评价与监管;
(2)对于按照省份逐个申请转基因作物安全证书的问题,建议实行分生态区种植的监管模式;建议全国一证制;
(3)对转基因作物及其产品强制性与零阈值标识问题,建议采用自愿标识政策;
(4)对于转基因作物安全性评价中出现的一些有争论事件建议:不应过分强调转基因作物的非预期效应;卡那霉素标记基因可以在转基因作物中继续使用;如果转基因作物与其非转基因对照实质等同,就没有必要进行动物试验。
3.本文通过分析新一代转基因作物--复合性状转基因作物的发展趋势、可能存在的风险以及各国对育种复合性状转基因作物的评价内容和方法,归纳了国际上对复合转基因作物进行安全性评价的三种主要模式:(1)美国加拿大模式;(2)日本与韩国模式;(3)欧盟模式。建议我国对育种复合性状转基因作物借鉴美国的管理模式,实行简单评价程序。
4.通过分析国外对高赖氨酸玉米和富含维生素A金米的安全性评价个案分析,提出对新一代转基因营养改良作物安全性评价的内容和方法:外源蛋白安全性评价要全面;应该对预期改变营养成分的代谢产物进行评价;要着重评价其目标营养成分改变的安全性,以及营养改变转基因作物的营养功效。
5.通过比较分析国际上对未来新一代转基因作物,尤其是药用转基因作物风险评价与管理对策研究,提出我国对未来药用转基因作物评价与监管的建议:完善药用转基因作物评价规定;对预期使用的评价要以其他生物反应器为对照进行评价;对食用安全与环境安全评价要以其非转基因对照比较;设计产品生产过程中无活性,加工工程中激活;利用遗传限制技术使药用植物花粉不育等。
这些建议供我国农业转基因安全性评价与监管决策部门制订新一代转基因作物安全性评价和监管措施时提供重要的科学参考。
The current large scale commercialization biotech crops are belong to the first generation of biotech crops—insect resistant and herbicide tolerant biotech crops. A serials of policies and regulations for biosafety assessment and monitoring measurements for the first generation of biotech crops have been published by the international organizations, foreign countries, as well as the Chinese government. With the rapid development of second generation of biotech crops globally, many countries and international communities have published their policies and regulations regarding to the biosafety assessment and monitoring measurements for these new biotech crops. However, the Chinese government did not publish any new policy or regulation yet regarding to the new generation of biotech crops. Therefore, it is very significant to study the biosafety assessment method to the new generation of biotech crops.
The objectives of this study are: (1) analyzing and comparing the worldwide policies and regulations on biosafety assessment and monitoring system to the first generation of biotech crops, conclude the achievements and problems in biosafety assessment and monitoring system of China, and provide suggestions to solve the problems existed; (2) investigate and analyzing the international commercial development, biosafety assessment and monitoring measurements of new generation of biotech crops: stack trait and nutritional improved biotech crops and PMPs, provide suggestions to the biosafety assessment method and monitoring measurements to the Chinese government. The main research achievements of this study are as follows:
1. Trough the comparison of biosafety assessment principles, contents, methodology and monitoring of biotech crops, the author has evaluated the achievements of biosafety assessment and monitoring of biotech crops in China:
(1) China is the first country in the developing world to established the biosafety assessment and monitoring regulation system to biotech crops, and commercialized Bt cotton as early as 1997;
(2) China effectively protected and promoted the research, development and commercialization of Bt cotton, great achievements have been made on the environmental , economic and social benefits, the commercialization of Bt cotton has saved the textile industry in China;
(3) New model of Bt cotton’s field management has been innovated, the“natural refuge”strategy has been demonstrated is a successful model to control the insect resistance to the Bt cotton under the field condition since the Bt cotton has been sustainable commercialization for 11 years in China;
(4) The detection system and detection standardization system of biotech crops and their products have been established and perfected step by step: 21 detection centers for GM organisms and their products have been in preparation and some of them have completed the certifying process. In addition, 37 national detection standards for GMOs environmental safety and food safety have been developed and published.
(5) The human health safety and environmental safety of GMOs have been protected. It has been demonstrated that all products include imported products as food/feed processing material or products for cultivation, which approved by MOA, are safe.
2. The study also pointed out the problems existed in the current biosafety assessment and monitoring system of biotech crop and their products in China, and further improvement suggestions have been provided:
a) For the current variety based regulation for the cultivation purpose, the author has suggested that an event based regulation, which is adopted by most of the countries, should be implemented;
b) Regarding to the safety certificate for commercial cultivation of new biotech crops by individual province, the author has suggested that a safety certificate for the whole country should be adopted except some special environment safety concerns (wild species of sexually cross pollinated varieties). The field monitoring system by ecological zone would be more reasonable.
c) To the issue of mandated labeling and zero threshold of 5 biotech crops and 17 biotech products, the author recommended that a volunteer labeling system should be adopted.
d) Regarding to some biosafety debate, the author has suggested that: the unintended effect of should not be overemphasized in the biosafety assessment process of biotech crop and their products; there is scientific evidence shows that the NPTII selectable marker for kanamycin resistance is a safe marker, and it can be used for the biotech crops; there is no need to conduct the animal trial if the gene donor has a safe food use history and the transgenic food is substantial equievlent to the non-transgenic food;
e) The commercialization has become the main restriction factor to the development of agricultural biotechnology, the author suggest the government should re-evaluate the benefit and risk of biotech crops, promote the commercialization of biotech rice and corn.
3. Through the study of biosafety assessment and monitoring of second generation of transgenic crops: the future development of stack trait biotech crops and the biosafety assessment content and methodology to the stack trait biotech crops from different countries, the author has concluded that there are 3 models to manage the breeding stack trait crops: (1) US and Canada model; (2) Japan and Korea model and (3) EU model. The author has suggested that China should take a position to simplify the assessment by providing bridge data for breeding stacks.
4. Through the evaluation of biosafety assessment to new generation of biotech crops with improved nutrition---high lysine corn and enriched Vitamin A rice, so-called golden rice, recommended by ILSI, the author has suggested the assessment pattern to nutrition improved biotech crops and their products: the assessment of expressed protein should be comprehensive; evaluate the metabolic products of target nutrients; focus on the nutrition composition analysis and nutrition efficacy evaluation.
5. Through the comparison and study of risk issue and monitoring measurements of second generation of biotech crops, the author provided the risk management and monitoring measurements to PMPs: develop the regulation to safety assessment of PMPs; set other bioreactor as control when evaluate the intended use; set the non-transgenic iso-line as control when evaluate the food and environment safety; design the product without activity during production of PMPs; using GURT to prevent the gene flow.
These recommendations and suggestions have provided very important background information for policy makers to draft the regulations to future biotech crops and products.
引文
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