德国科学家揭先正达转基因玉米MIR162安全评估造假欺骗 转基因玉米的危害

德国“生物技术影响独立评估研究所”（TestBiotech）科学家揭露揭先正达转基因玉米MIR162安全评估造假欺骗18个问题，批准这样的转基因作物颁发“安全证书”是残害中国人民法西斯行为！：1）转基因玉米MIR162逐年在不同地方种植的额外蛋白表达含量发生变化，表明不同环境状况影响其基因表达水平”，证明转基因玉米MIR162不稳定；2）对“基因构成及其功能稳定性”没进行“极端气候条件下试验”；3）没有“对转入额外基因基因组活动性以及作物代谢进行研究”；4）“对测量作物不同部位VIP3A毒素与磷酸甘露糖异构酶（PMI）含量的方法，没有由独立实验室进行评估”；4）“先正达提供的数据表明，转基因玉米MIR162与其传统非转基因作物之间”，在有益营养“成分与农艺性状表现方面，存在数项显著差别”；5）没有“在不同环境条件下通过应用代谢分析等方法进一步对这些实际的差异进行研究”；6）“缺乏对于相关作物成分的基础信息”，先正达故意造假，用美国土壤气候条件下种植的转基因玉米MIR162某些数据，代替“不代表这些玉米将种植的相关地球气候区域”的巴西种植转基因玉米MIR162对应数据；7）“转基因玉米MIR162产生的VIP3Aa20毒素，从来没有由农药监管机构进行评估”，安全评估却“假设人类与动物，甚至消费者，过去接触过VIP毒素“；8）安全评估无视“先正达转基因玉米MIR162中产生的VIP毒素与传统混合杀虫剂中用的VIP毒素有几种重要的差别”，无视“将DNA迁移转入作物基因组的过程中，其DNA数项细节被改变”；9）“先正达转基因玉米MIR162中产生VIP毒素”，然而“人们还不理解VIP蛋白质呈现选择性和毒性的详细情况。没有这样的知识，对VIP蛋白对食品链长期影响无法结论”；10）更应当引起担心的问题被无视:“与Cry1Ab蛋白毒素相比，VIP3A毒素的毒性看来不依赖特定的受体”，也“无法假设VIP3A也有这样的选择性”，无法假设VIP3A毒素“对哺乳动物的安全性”；11）“体内和体外进行的研究的结果，…例如，在90天的研究中有数项显著的发现，如喂养（MIR162）转基因玉米的处理组中发现肿瘤与低数量的细胞计数”；12）“已发布学术论文表明，VIP3A蛋白，可能会显示与其他Bt毒素、其他压力和植物酶之间的协同效应和交互作用，…由于这些（MIR162）作物将在食品与饲料中使用，可能与其他转基因作物混合，有必要进行进一步试验来确定潜在的积累性或结合性作用”；13）安全评估对先正达MIR162转基因玉米“整个作物对这些蛋白的热稳定”没进行试验研究；14）已知道转基因Bt作物“Cry1Ab毒素在胃蛋白酶消化试验中很快分解，但是在真实条件下能够生存通过肠道”，对MIR162转基因玉米VIP3A蛋白“没做任何试验对其他的蛋白真实条件下的分解进行研究”；15）“VIP3A蛋白可能具有辅佐剂作用，如某些Cry蛋白那样，因此提高植物内源性蛋白质的免疫反应。如果VIP3A蛋白有这样作用的话，那么对玉米蛋白的过敏性反应可能显著加强”；16）“对（MIR162）玉米作物过敏性蛋白的成分，与对应非转基因作物相比，是否发生变化，没进行任何研究”；17）安全评估声称“（MIR162）对环境的接触是通过动物的粪便与排泄。然而，对这些转入的额外蛋白消化过程中的命运，或者对它们在粪便中的含量与它们在环境中的命运，没有提供任何数据或进行评估”；18）安全评估机构“声称的没有必要监控健康影响的意见是错误的”；【结论：必须拒绝监管机构的意见，拒绝批准先正达转基因玉米MIR162！】

（德国）《测试生物技术》科学家揭露先正达转基因玉米MIR162评估造假欺骗18个问题，批准这样的转基因作物颁发“安全证书”是残害中国人民法西斯行为！

翻译、评论：陈一文（cheniwan@cei.gov.cn）

《转基因技术与人类安全》研究专家、80年代前全国青联委员

《新浪网》“陈一文顾问博客”：http://blog.sina.com.cn/cheniwan

Testbiotech comment on EFSA Scientific Opinion onapplication (EFSA-GMO-DE-2010-82) for the placing on the market ofinsectresistant genetically modified maize MIR162 for food and feeduses, import and processing under Regulation (EC) No 1829/2003 fromSyngenta

（德国）《测试生物技术》对欧洲食品安全机构（EFSA）“对于先正达依据法规（EC）No1829/2003申请（EFSA-GMO-DE-2010-82）将抗虫转基因玉米MIR162上市作为食品与饲料使用，进口和加工”的科学意见的评论

http://www.testbiotech.org/sites/default/files/TBTComment_MIR_162_Import_0.pdf

德国《测试生物技术》（Test Biotech）2012-07-24

Molecular data

分子数据

The data as provided by Syngentamake it evident that there is a year-to-year and site-to-sitevariation in the content of the additional proteins expression, andtherefore shows that environmental conditions will impact the levelof gene expression.

先正达提供的数据成为证据，证实先正达转基因玉米MIR162逐年在不同地方种植的额外蛋白表达含量发生变化，表明不同的环境状况影响其基因表达的水平。

Nevertheless, the expression ofthe gene construct and the functional stability of the geneconstruct were, for example, not tested under extreme climateconditions such as drought and flooding which are likely to occurunder present ongoing climate change.

不过，基因构成及其功能稳定性，也没有极端气候条件下试验，例如目前气候变化条件下易于发生的干旱与洪涝状况下。

Investigations under controlledenvironmental conditions should have been performed to determinethe actual range of variation and to identify relevant impactfactors.

应当进行控制的环境状况下的表现进行研究，以便判定实际范围变化与鉴别相关影响因素。

Further, the effects of theadditional genes on the activity of the plants´ genome and theplants´ metabolism should have been investigated using methods suchas metabolic profiling.

此外，还应当使用例如代谢分析这样的方法对转入的额外基因对于作物基因组的活动性以及作物的代谢进行研究。

The methods for measuring thecontent of VIP3A toxin and the phosphomannose isomerase (PMI)enzyme in parts of the plants were not evaluated by independentlaboratories. Hence, the data by Syngenta should not be consideredas reliable.

对测量作物不同部分的VIP3A毒素与磷酸甘露糖异构酶（PMI）含量的方法，没有由独立实验室进行评估。因此，先正达提供的数据不应认为可靠。

Comparative assessment (for compositionalanalysis and agronomic traits and GM phenotype)

比较性评估（对成分分析与农艺性状和转基因表型）

The data as provided by Syngentashow several significant differences between MIR162 and itsconventional counterparts in composition and agronomic performance.These differences have been declared irrelevant by referring tohistorical data from the ILSI Database, which is known to beunreliable.

先正达提供的数据表明，转基因玉米MIR162与其传统非转基因作物之间，在成分与农艺性状表现方面，存在数项显著差别。这些差别被称为无关紧要，通过参照ILSI数据库的历史性数据，但是该数据库已知不可靠。

Instead of using these historicaldata, the actual differences should have investigated further undervarious environmental conditions and by applying methods such asmetabolic profiling.

不应依赖这些历史数据，而应该在不同环境条件下通过应用代谢分析等方法进一步对这些实际的差异进行研究。

The data as presented by Syngentadoes not represent the relevant geo-climatic regions where thismaize will be grown. The data from Brazil, for instance, lackedbasic information on relevant plant constituents. But instead ofrepeating the trials in Brazil, additional data were generated inthe US. As a result, relevant data from other regions (beside theUS) are missing.

先正达公司提供的数据，并不代表这些玉米将种植的相关地球气候区域。来自巴西的数据，例如，缺乏对于相关作物成分的基础信息。但是，不是在巴西重复试验获得这些数据，而是在美国产生额外的数据。作为结果，美国以外其他区域就缺乏了这些相关数据。

Toxicology

毒理学

The VIP3Aa20 toxin as produced inthe plants was never assessed by pesticide authorisation. EFSAassumes that humans and animals, and even consumers might have beenexposed to VIPs before:

转基因玉米MIR162中产生的VIP3Aa20毒素，从来没有由农药监管机构进行评估。欧洲食品安全机构（EFSA）假设人类与动物，甚至消费者，过去接触过VIP毒素：

„One biopesticide contained animmunoreactive protein with a molecular weight equal to that ofVip3Aa20 as present in maize MIR162. This leads the EFSA GMO Panelto conclude that the data indicate that humans and animals,including consumers and agricultural workers, may already have beenexposed to low levels of Vips.“

“一种生物杀虫剂含有分子重量等于玉米MIR162Vip3Aa20的免疫反应性的蛋白质。这引导欧洲食品安全机构（EFSA）的转基因专家组结论：这些数据表明人类与动物，包括消费者与农业工人，可能以及接触于低水平的Vip毒素。

However, this is not only a veryvague but also an inadequate assumption, with no factual basis forthe risk assessment of VIPs as produced in the plants.

然而，这不仅是一项非常模糊的假设，而且是一项不充分的驾驶，对先正达转基因玉米MIR162中产生的VIP毒素没有任何基于事实的风险评估。

There are several importantdifferences between the toxin as produced in the plants and itsusage in traditional mixtures.

先正达转基因玉米MIR162中产生的VIP毒素与传统混合杀虫剂中用的VIP毒素有几种重要的差别。

In contrast to the very targeteduse of traditional sprays, the toxin is applied throughout thewhole period of vegetation, thus the exposure in the food chainwill be different. Further, for the toxin to be effective it has tobe used in higher concentrations than traditional mixtures: In themixtures, additive and synergistic effects will require only a lowlevel of the single compounds. Additionally, several details of theDNA sequence were changed during the process of transferring theDNA into the plants´genome.

与传统生物杀虫剂对非常准确目标喷洒不同，先正达转基因玉米MIR162中产生的VIP毒素应用与整个种植过程，因而食品供应链中的接触非常不同。此外，为使转基因玉米MIR162中的VIP毒素有效，其浓度必须高于传统生物杀虫混合剂中的浓度：在传统生物杀虫混合剂中，添加剂与协同效应仅需要使用低水平的单一成分。此外，将DNA迁移转入作物基因组的过程中，其DNA数项细节被改变。

It should also be acknowledgedthat the mode of action of VIP proteins is still unknown and simplybased on preliminary assumptions derived from the outcome of just afew studies. Particular details that render selectivity andtoxicity of the VIP proteins are not understood. Without suchknowledge, no conclusion can be drawn upon its (long time) effectsfor the food chain.

还应当承认，VIP蛋白质的作用方式至今不清而且基于来自有限几项研究结果的初步假设。人们还不理解VIP蛋白质呈现选择性和毒性的详细情况。没有这样的知识，对VIP蛋白对于食品链的长期影响无法结论。

It should be a matter of concernthat in comparison with Cry1Ab the toxicity of VIP3A does notappear to depend upon specific receptors. As Lee at al., 2003explains:

应当引起担心：与（转基因Bt作物的）Cry1Ab蛋白毒素相比，（先正达转基因玉米MIR162的）VIP3A毒素的毒性看来不依赖特定的受体，如Lee at al.,2003的论文解释的那样：

“Planar lipid bilayerexperiments validate and extend the conclusions from our isolatedmidgut voltage clamp data in that processed Vip3A demonstrates theability to form distinct ion channels in the absence of anyreceptors.”

“平面脂质双分子层的实验，验证和扩展从我们的孤立中肠电压钳位数据得到的结论：处理的Vip3A演示了没有任何受体情况下形成不同离子通道的能力。”

Specific receptors in the gut ofinsects are used in the case of Cry toxins to assume selectivityand safety for mammalians. Since toxicity of VIP3A does not appearto depend these receptors, selectivity cannot beassumed.

在（转基因Bt作物）Cry蛋白毒素情况下，使用昆虫肠道中特定的受体来假设其选择性与对哺乳动物的安全性。由于VIP3A的毒性没有看起来依赖于这些受体，无法假设VIP3A也有这样的选择性。

The toxicological studies asperformed in vivo and in vitro are in no way sufficient to proveselectivity of the toxin and safe use in food and feed. Theseinvestigations cannot be seen as a replacement for missing dataunder EU pesticide regulation. Based on the existingdata, no conclusion can be drawn on the safety of the toxin and thegenetically engineered maize.

体内和体外进行的毒理学研究以任何方式都不足以证明（先正达转基因玉米MIR162的VIP3A蛋白）毒素在食品与饲料中的使用安全。这些研究无法看为可以取代欧盟杀虫剂法规中缺乏的数据。基于现有的数据，对（VIP3A蛋白）毒素与（先正达MIR162）转基因玉米的安全性不能得出结论。

In the Council Conclusions onGenetically Modified Organisms (GMOs) from the Council meeting on 4December 2008, Member States requested a revision of current EUregulations to close the loopholes between the pesticide regulationand the regulation on genetically engineered plants. This demand isin no way confined to the usage of the genetically engineeredplants in agriculture, but includes all relevant products, whichmight be authorised on the market [1]

2008年12月4日举行的理事会对转基因生物体的理事会结论中，成员国要求对现有的欧盟法规做出修改，以便堵上杀虫剂法规与转基因作物法规之间的漏洞。这样的要求以任何方式不限于转基因作物在农业中的使用，但是包括所有相关的产品，包括可能授权已经上市销售的产品。[1]

[1] http://www.consilium.europa.eu/ueDocs/cms_Data/docs/pressdata/en/envir/104509.pdf

“(...) the mandate includesexamination of the criteria and requirements for assessing allGMPs, including GMPs that produce active substances covered bydirective 91/414/EEC and herbicide-tolerant GMPs with a view toreviewing them if necessary; (…) RECALLS that the use of plantprotection products implies authorisations at national level andEMPHASISES THE NEED for competent authorities involved with theimplementation of Directive 2001/18/EC and of Council Directive91/414/EEC concerning the placing of plant protection products onthe market, within the Commission and at national level, tocoordinate their action as far as possible;“

“（…）该授权对评估所有转基因作物进行审查的标准和要求，包括指令91/414/EEC下产生活性物质的转基因作物与抗除草剂转基因作物，而且在必要时再次对它们进行审查；（…）。提请注意，作物保护产品的使用意味着获得国家级别的授权，而且强调，对于让作物保护产品上市销售需要委员会内与国家级别的主管部门实施指令2001/18/EC与理事会指令91/414/EEC，来尽可能协调他们的措施；”

EFSA risk assessment completelyignores these demands.

欧洲食品安全机构（EFSA）的风险评估完全忽略了这些要求。

Looking at the comments made byexperts from Member States, it is evident that the outcome of thein vitro and in vivo studies can be interpreted in different ways.For example, there are several significant findings in the 90 daysstudy such as tumors and a lower number of cell counts in the groupfed with the genetically engineered maize. These findings shouldhave been investigated further.

看了成员过的专家做出的评论，体内和体外进行的研究的结果，显然可以其他方式解释。例如，在90天的研究中有数项显著的发现，如喂养（先正达MIR162）转基因玉米的处理组中发现肿瘤与低数量的细胞计数。这些发现应当进一步研究。

There are also severalpublications indicating that Bt proteins such as VIP3A are likelyto show synergies and interactions with other Bt toxins, otherstressors and plant enzymes (for overview see Schnepf et al., 1998;Then, 2010). But no tests were performed to determine potentialcombinatorial or accumulated effects of the toxins, nor of anyother factors such as other toxic compounds, bacteria, plantenzymes and pesticides in mammals.

还有数项已经发布了的学术论文表明，例如VIP3A这样的Bt蛋白，可能会显示与其他Bt毒素、其他压力和植物酶之间的协同效应和交互作用（这方面的综述看这些论文，Schnepfet al., 1998; Then, 2010）。但是没有进行确定这些毒素潜在结合性或积累性作用的任何试验，也没有对其他毒素成分、细菌、作物酶与杀虫剂等其他因素在哺乳动物体内的作用做任何试验。

Since these plants will be used infood and feed and might be mixed with other genetically engineeredplants, further tests need to be carried out to determine potentialaccumulative or combinatorial effects.

由于这些（先正达MIR162转基因玉米）作物将在食品与饲料中使用，可能与其他转基因作物混合，有必要进行进一步试验来确定潜在的积累性或结合性作用。

Data is also missing on theeffects that processing has on the proteins produced in the plants.Since there might be some interactivity between the stability ofthe proteins and their surroundings in the plants, the experimentson the heat stability of the proteins should have been conductedusing whole plants.

还缺乏对于加工过程对（先正达MIR162转基因玉米）作物中产生的（VIP3A）蛋白造成的影响的数据。由于（先正达MIR162转基因玉米VIP3A）蛋白的稳定性可能与作物中这些蛋白的环境产生某些互相作用性，需要使用整个作物对这些蛋白的热稳定性做实验。

References:

参考文献：

Lee, M.K., Walters, F.S., Hart,H., Palekar, N., Chen, J.-S. (2003) The mode of action ofthe

Bacillus thuringiensis vegetativeinsecticidal protein Vip3A differs from that of Cry1Abδ-

endotoxin. Applied andEnvironmental Microbiology, 69(8): 4648–4657.

Schnepf, E., Crickmore, N., vanRie, J., Lereclus, D., Baum, J., Feitelson, J., Zeigler, D.R. &Dean, D.H. (1998) Bacillus thuringiensis and its pesticidal crystalproteins, Microbiol Mol Biol Rev., 62

(3): 775–806.

Then, C. (2010) Risk assessment oftoxins derived from Bacillus thuringiensis-synergism, efficacy, andselectivity. Environ Sci Pollut Res Int; 17(3):791-7.

Allergenicity

变应原性

Allergenicity was assessed byapplying a pepsin digestion assay. But it is known that thesestudies are insufficient to judge on the degradation of the proteinunder real conditions. For example, Cry1Ab toxins are shown to bedegraded quickly in pepsin digestion, but can nevertheless cansurvive the passage through the intestine under real conditions,(Chowdhury et al., 2003; Walsh et al., 2011). But no tests wereperformed to investigate the degradation of the additional proteinsunder real conditions.

变应原性评估通过胃蛋白酶消化试验。但是，已经知道这些研究不足于判断（先正达MIR162转基因玉米VIP3A）蛋白真实条件下的分价。例如，（转基因Bt作物的）Cry1Ab毒素在胃蛋白酶消化试验中很快分解，但是在真实条件下能够生存通过肠道，（Chowdhuryet al., 2003; Walsh et al., 2011）。但是没有做任何试验对对其他的蛋白真实条件下的分解进行研究。

Furthermore, besides potentialallergic reactions, no targeted investigations were performed toinvestigate the impact on the immune systems. Since proteins frombacteria are, in general, likely to cause immune responses inhumans, the additional proteins should have been subjected to moredetailed testing. For example, VIP3A might act like an adjuvans asknown from some Cry proteins, and could, therefore, boost immunereactions to the plants´ endogenous proteins. If this were the casethen allergic reactions to the maize proteins could besignificantly enhanced.

此外，除了潜在过敏反应，对这些蛋白对免疫系统的影响没有进行任何有目标的研究。因为来自细菌的蛋白，通常，有可能在人类中造成免疫反应，其他的蛋白应当成为更加详尽试验的对象。例如，VIP3A蛋白有可能具有辅佐剂的作用，如某些Cry蛋白那样，因此，提高植物内源性蛋白质的免疫反应。如果VIP3A蛋白有这样作用的话，那么对玉米蛋白的过敏性反应可能显著加强。

No investigations were conductedto find out whether the content of allergenic proteins in the maizeplants is changed in comparison to its comparators.

对（先正达MIR162转基因）玉米作物中的过敏性蛋白的成分，与对应非转基因作物相比，是否发生变化，没有进行任何研究。

References:

参考文献：

Chowdhury, E. H., Kuribara, H.,Hino, A., Sultana, P., Mikami, O., Shimada, N., Guruge, K. S.,Saito, M., Nakajima, Y. (2003) Detection of corn intrinsic andrecombinant DNA fragments and Cry1Ab protein in thegastrointestinal contents of pigs fed genetically modified cornBt11. J. Anim. Sci., 81: 2546-2551.

Walsh, M.C., Buzoianu, S.G.,Gardiner, G.E., Rea M.C., Gelencsér, E., Jánosi A., Epstein M.M.,Ross, R.P., Lawlor, P.G. (2011) Fate of Transgenic DNA from orallyodministered Bt MON810 maize and effects on immune response andgrowth in pigs. PLoS ONE 6(11): e27177,doi:10.1371/journal.pone.0027177.

Environmental risk assessment

环境性风险评估

EFSA states that the exposure tothe environment of maize MIR162 would be through manure and faecesfrom animals. However, no data are given or assessed about the fateof the additional proteins during digestion, their content inmanure and its fate in the environment. Thus EFSA completely failsto conduct the required environmental risk assessment.

欧洲食品安全机构（EFSA）声称，（先正达转基因）对环境的接触是通过动物的粪便与排泄。然而，对这些转入的额外的蛋白消化过程中的命运，或者对它们在粪便中的含量与它们在环境中的命运，没有提供任何数据或进行评估。因而欧洲食品安全机构（EFSA）完全未能进行所需要的环境性风险评估。

Others

其他事项

As a recent legal dossier compiledby Professor Ludwig Kraemer shows, the decision not to monitor anyhealth effects violates the requirements of EU regulations:Directive 2001/18 and Regulation 1829/2003 both require thatpotential adverse effects on human health from genetically modifiedplants are controlled during the use and consumption stage,including those cases where such effects are unlikely tooccur.

如路得维格·克拉莫教授最近汇编的法律文件档案显示的那样，决定不监视任何健康影响的决定违反欧盟法规：指令2001/18与法规1829/2003均要求，对转基因作物对人类健康的潜在损害影响要在使用与消费阶段进行控制，包括对不大可能发生的这样的影响的情况进行控制。

Thus EFSA’s opinion thatmonitoring health effects is unnecessary, is wrong.

因而欧盟食品安全机构（EFSA）声称的没有必要监控健康影响的意见是错误的。

References:

参考资料：

Kraemer L. (2012) The consumptionof genetically modified plants and the potential presence ofherbicide residues, legal dossier compiled on behalf ofTestbiotech,

http://www.testbiotech.de/sites/default/files/Legal_Dossier_Kraemer_Pesticide_RA_PMP.pdf

Conclusion and recommendations:The opinion of EFSA should be rejected.

结论与推荐意见：应当拒绝欧盟食品安全机构（EFSA）的意见。

参考资料：

习近平：人民身体健康是全面建成小康社会的重要内涵

http://blog.sina.com.cn/s/blog_4bb17e9d0102e9bo.html

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