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翻译:MON863-有计划的欺骗

这是绿色和平组织整理的关于孟山都公司在欧洲获得MON863转基因玉米生产许可的进程表,期间呈现了欧洲许多科学家的反对之声,但最终抵不过欧洲议会等精英集团的操纵。逐段翻译在这里,欢迎大家指正。

The MON863 case - a chronicle of systematic deception

MON863——有计划的欺骗史

August 13, 2002: The Monsanto company submits to the German authorities an application to import genetically engineered MON863 maize into the EU. This submission contains a 90-day rat feeding study.

2002年8月13日:孟山都公司向德国当局提交了向欧盟引进转基因玉米MON863的申请。这项提案中包括一个90天饲鼠试验研究。

MON863 is a genetically modified corn that expresses a Bt-toxin. This toxin is a modified version of the delta endotoxin Cry3Bb1 which originates from the microorganism Bacillus thuringiensis. The genetic manipulation is aimed at protecting maize plants against a pest called corn rootworm (Diabrotica spp.).

MON863是一种可以产生Bt毒素的转基因玉米,这种毒素是delta内毒素Cry3Bb1的变体,而Cry3Bb1则来自于苏云金杆菌。这项转基因操作是为了使玉米植株对抗一种叫做玉米虫(侵害玉米根须)的害虫。

MON863 differs from other Bt-corns already placed on the market (MON810, Bt11, Bt176), which produce a modified Cry1Ab toxin conferring resistance to a pest called European corn borer (Ostrinia nubilalis), in that it produces an artificial Cry3Bb1 toxin. In addition to the modified Cry3Bb1 toxin gene MON863 contains an antibiotic resistance marker gene.

MON863和其他已经上市的Bt毒素转基因玉米(如MON810,Bt11,Bt176)的不同之处在于,它不仅可生成一种叫做Cry1Ab的人造毒素,这种毒素可以使玉米对抗欧洲玉米蛀虫,它还可以生成人造Cry3Bb1毒素。此外,MON863还含有一种抗菌基因标记。

Outside the EU MON863 is approved for cultivation in the USA and Canada, and for food and feed in Australia, China, Japan, Korea, Mexico, the Philippines and Taiwan.

在欧盟之外,MON863获得了在美国和加拿大种植的许可,还在澳大利亚、中国、日本、韩国、墨西哥、菲律宾和台湾获得了用做食物和饲料的生产许可。

Based on the results of the 90-day rat feeding study presented in the application the Monsanto company concludes: “Toxicological parameters evaluated were survival, clinical signs, body weight changes, food consumption, clinical pathology, organ weights, and macroscopic pathology. There were no test article related changes in any of the aforementioned toxicological parameters”.

基于申请书中提到的90天饲鼠试验,孟山都认为:“观测的毒物学指标有存活数、临床症状、体重变化、进食量、临床病理学、脏器重量以及宏观病理学。没有测试数据能够表明老鼠在上述毒物学指标上表现出了变化。”

In the conclusions of the rat feeding study provided by Monsanto one can find a disturbing fact, namely that the feeding study was performed by a third company (Covance Laboratories), but the statistical analysis of the data was made by Monsanto itself..

在孟山都提出的饲鼠试验研究报告中我们会发现一个令人疑惑的事实,孟山都一方面声明该项研究是由第三方公司(Covance实验室)完成的,但数据的统计分析却又是由孟山都自己完成的。

September 2002: Experts at the French Genetic Engineering Commission (CGB,

Commission du Génie Biomoléculaire) raise critical questions regarding the

toxicological test data derived from the rat feeding study with MON863.

2002年9月:法国基因工程委员会(CGB)的专家就该饲鼠试验得出的毒理学数据向孟山都提出严重质疑。

April 8, 2003: The German competent authorities publish their assessment of the MON863 application. In their report they state that the amino acid sequence of the Cry3B1 toxin produced by the MON863 maize has similarities to some other toxins. Most notably, the German authority found some “homologies to sequences from Clostridium bifermentans, Caenorhabditis elegans, Vibrio cholerae and Bacillus popilliae.” These homologies are of high relevance in respect to human and animal health. Despite the similarities to other toxins found the German authorities did not investigate the results from the 90-day rat feeding study in detail and therefore failed to find out if there might be some indices for mammaliantoxicity. Instead, the German authorities interpreted the similarities found “as being biologically irrelevant due to lack of indications of mammalian toxic activity.”

2003年4月8日:德国主管部门发布了他们对MON863申请的评估报告。该报告认为MON863玉米所产生的Cry3Bb1毒素的氨基酸序列和另一些毒素相似,特别是,和bifermentans梭菌、Caenorhabditis elegans、cholerae霍乱菌以及popilliae杆菌相似。考虑到人类和动物的健康问题,这些相似点是亟需重视的。尽管发现了与其他毒素存在相似之处,德国当局并没有深入调查90天饲鼠试验,因此也就没有确定是否对哺乳动物有毒性影响。相反,德国当局把这些相似点解释为“由于缺乏哺乳动物中毒报告,因此这些相似之处在生物学上是无关的”

The 90 day rat feeding study which shows significant changes in the blood of the animals was mentioned in the German assessment report as follows: “From this extensive study, it can be deduced that even after long term oral exposure to MON863 maize kernels, no harmful effects are to be expected.” The German report does not mention any significant findings, but by and large repeats Monanto"s conclusion that “… no substance-specific biologically relevant effects were seen in comparison to controls …".

在90天饲鼠试验中,老鼠的血液出现了显著的变化,德国当局的评估报告中是这样说的:“从这个详细的研究可以推断,即使经过长时期的MON863玉米喂食,也不会看到有害的影响。”这份德国报告没有提到任何有意义的发现,除了大段重复孟山都的结论“…在试验组和对照组的比较中,没有发现生物学上不同影响…”(注:control group,试验中的控制组,不做任何实验处理,用作与试验组对照,也译为对照组。)

June 2003: A narrow majority of the French CGB"s experts approves the results of the MON863 tests.

2003年6月:法国基因工程委员会(CGB)以微弱多数通过了MON863的测试结果。

November 10, 2003: The French group CRIIGEN (Committee for Independent Research and Genetic Engineering) appeals to the French Commission CADA (Commission of Access to administrative Documents) in order to obtain the reports of CGB referring to significant health effects in the rat feeding study.

The French authorities had declared the CGB reports as being confidential, but CRIIGEN wins the case and presents the reports to journalists (see below).

2003年11月10日:法国基因工程独立研究委员会(CRIIGEN)控告法国档案管理局要求给出CGB的报告原文,该报告曾提到在饲鼠试验引起老鼠出现显著的健康变化。法国当局宣布该报告内容保密,但CRIIGEN胜诉并把该报告交给了记者。(见后)

April 2, 2004: The European Food Safety Authority (EFSA) publishes its opinion on

Monsanto"s MON863 application. In their conclusion the EFSA"s experts state, “The results of the 90-day sub-chronic rodent studies do not indicate adverse effects from consumption of MON863 and MON810 and the Panel concludes that there are no concerns over their safety.”

In its opinion EFSA mentions the significant findings in the rat feeding study as follows:

“Some differences were observed in haematological parameters, including total white blood cell, lymphocyte and basophil counts.” But EFSA plays down these findings with a very general statement, saying that “These differences are not considered to be biologically meaningful since they fall within the standard deviation of the reference control population.”

2004年4月2日:欧洲食品安全局(EFSA)发布了其对孟山都MON863申请的评议。在其结论中,EFSA的专家声称:“90天饲鼠试验的结果不能表明MON863和MON810饲养造成了有害影响,因此全体评审员认为不需要考虑安全问题”

在这份评议中,EFSA提到了在饲鼠试验中发现的显著差异:“在血液指标上观察到了一些变化,包括白细胞总量、淋巴球和嗜碱细胞总量。”但是EFSA以一种无所谓的语气(general statement)说道:“这些不同并无生物学上的意义,因为它们处于对照组的标准差变化范围之内。”

Moreover, EFSA plays down significant findings in kidney weights observed in the rat feeding study: “The overall conclusion is that no differences in relation to feeding in MON863 maize were observed on kidney weights, kidney weights relative to body weights and kidney weights relative to brain weight.”

而且,EFSA对饲鼠试验中老鼠肾脏重量的显著变化也轻描淡写:“总的结论是肾重的变化与喂食MON863并无关系,因为肾重和体重有关,也和脑重有关。”

Finally, EFSA discusses some microscopic pathological changes in kidneys. “However, a statistically significant lower incidence of mineralized kidney tubulus was noted for rats fed 33% MON863 maize compared to those fed the control maize during histopathology after termination. These findings are not considered to pose concerns over the safety of MON863 maize.”

最后,EFSA讨论了在老鼠肾脏观察到的微生物病理学变化,“然而,和那些喂食非转基因普通玉米的对照组老鼠比较,喂食33%MON863玉米饲料的老鼠出现了肾脏矿物质含量指标的明显下降。我们认为这些发现并不涉及MON863的安全性问题”

April 23, 2004: After CRIIGEN succeeded in accessing the report of CGB, the French newspaper Le Monde exposes the MON863 scandal. The newspaper covers the significant changes in the blood of rats, which were fed with MON863, and reveals that the CGB"s experts had expressed safety concerns.

2004年4月23日:CRIIGEN成功拿到CGB的报告原文后,法国报纸Le Monde披露了MON863丑闻。新闻界掩饰了喂食MON863后老鼠在血液中出现的显著变化,并显示CGB的专家已经考虑到了安全问题。

May 2004: Greenpeace requests the data from the rat feeding study with MON863 from the German authorities.

2004年5月:绿色和平要求德国当局给出MON863饲鼠试验的原始数据。

August 4, 2004: In a response to the German authorities Monsanto denies access to data, and only provides a short “Supplemental analysis of selected findings on the rat 90-day feeding study with MON863 maize”.

2004年8月4日:孟山都拒绝披露数据,只提供一份简短的对已挑选指标的后续分析作为对德国当局的回复。

August 2004: CRIIGEN asks the French Ministry of Agriculture for access to the original toxicological data from animal feeding trials done with MON863 maize, NK603 maize, Bt11 maize and GT73 oilseed rape.

2004年8月:CRIIGEN要求法国农业部取得关于MON863玉米、NK603玉米、Bt11玉米和GT73油菜籽的毒理学饲鼠试验的原始数据。

January 20, 2005: The French Ministry of Agriculture confirms that the original data from the toxicological tests should be confidential.

2005年1月20日:法国农业部声明毒理学测试数据保密。

March 21, 2005: The German authorities announce that the data from the rat feeding study shall be given to Greenpeace. Monsanto appeals against the decision of the German authorities and submits the case to the Cologne administrative court.

2005年3月21日:德国当局宣布饲鼠试验数据应当交给绿色和平。孟山都反对德国当局的决定并上诉到科隆行政法院(Cologne administrative court)。

June 1, 2005: Bruce Hammond (a scientist at the Monsanto company) sends in a further evaluation of the rat feeding data to the “Food and Chemical Toxicology” scientific journal . The data are published in 2006. In his conclusion the author states, “The summary prepared by the GMO Panel of the European Food Safety Authority best captures the prevailing scientific conclusions regarding the findings from this study. EFSA concluded that the results of the 90-day rodent study do not indicate adverse effects from consumption of maize line MON863”.

2005年6月1日:Bruce Hammond(孟山都的研究员)在《食品与化学》杂志(Food and Chemical Toxicology)上发表了一份对饲鼠试验数据的深入评估报告。数据在2006年发布。在他的结论中作者声称:“欧洲食品安全局(EFSA)评审委员会的报告很好地抓住了该研究的优势。EFSA认为90天饲鼠试验的结果并不表明老鼠出现的有害反应是由MON863引起的。”

June 9, 2005: The Cologne administrative court decides that Monsanto has to give their rat feeding study data to Greenpeace.

2005年6月9日:科隆行政法院判决孟山都将饲鼠试验研究数据交给绿色和平。

June 20, 2005: The Muenster Higher administrative court (Germany) reaffirms that the data from the rat feeding study shall be given to Greenpeace. Greenpeace publishes the complete rat feeding study (more than 1000 pages) on the internet.

2005年6月20日:德国门斯特高等行政法院重申,饲鼠试验数据应该交给绿色和平。绿色和平随即在网上发布了数据全文(超过1000页)。

June 24, 2005: The Council of EU environment ministers votes on market authorization for MON863 for animal feed. The majority of the ministers abstain or vote against the authorisation. As a qualified majority for either rejecting or approving the application fails to be reached, the final decision reverts to the European Commission.

2005年6月24日:欧盟环境部长委员会投票决定是否给予MON863作为动物饲料的许可。大部分官员投了弃权票或者反对票。由于无论反对还是赞同都没有达到有效多数,因此该申请的最终决定权交给了欧洲议会。

September 15, 2005: An independent expert on biostatistics from the University of Hamburg makes a written statement to Greenpeace on the statistical design of Monsanto"s rat feeding study. The expert states, “Significant differences were indeed found in the study, and afterwards were classified as irrelevant. (This is as if a marksman had shot at a wall and the rings of a target were drawn around where the shot had made a hole, and it was then maintained he had hit the target dead centre.)”

2005年9月15日:汉堡大学的一位生物统计学专家给绿色和平发来一份手写的声明,指出孟山都饲鼠试验研究中数据统计存在问题。该研究者说:“研究中确实发现了显著差异,之后却被定为不相关。(这就好比一名射手先朝墙上开枪再画靶圈,他就永远命中红心了。)”

October 2005: A confidential study prepared on behalf of the Austrian government concludes that “A complete re-evaluation of the study would be indicated, but as the design and the methods are inadequate, a repetition of the study seems desirable.”

2005年10月:一份为澳大利亚政府准备的秘密报告指出,“对研究完全进行重新评估是必要的,但由于其设计和方法本身有缺陷,所以必须重做一次实验”。

October 24, 2005: The Council of EU agriculture ministers vote on market authorisation for MON863 maize for food. As a qualified majority for either rejecting or approving the application fails to be reached, the final decision reverts to the European Commission .

2005年10月24日:欧盟农业部长委员会投票决定是否给予MON863玉米以食物生产许可。由于反对和赞同都未能达到有效多数,因此最终决定权交给了欧洲议会。

Just before the meeting of the EU agriculture ministers experts from the French CRIIGEN group publish a report on the first findings from the evaluation of Monsanto"s rat feeding study data. In this evaluation all data from Monsanto"s rat feeding study were retyped and subjected to comprehensive statistical analysis. The report states that the “findings clearly indicate major failures of statistical analysis as performed by Monsanto.” CRIIGEN calls for a complete reassessment of all data from the rat feeding study.

就在欧洲农业部长会议举行前,法国CRIIGEN的研究者发表了对孟山都饲鼠试验数据进行检验后得到的首批发现,在这次研究中,所有孟山都数据被重新整理并采用了全面的统计分析。报告显示“清楚表明孟山都在统计上存在严重问题”。CRIIGEN呼吁对饲鼠试验的所有数据彻底进行重新检验。

January 13, 2006: Despite the concerns raised by EU member states, members of the EU parliament and 10,000 cyberactivists alerted by Greenpeace, the EU Commission authorises the placing on the market of foods and food ingredients derived from MON863 maize.

2006年1月13日:尽管有欧盟成员国与欧盟成员国议会的担忧,有绿色和平的10000份网络团体的抗议,欧盟委员会批准了由MON863玉米制成的食物或食物成分进入欧洲市场的许可。

February 2006: Greenpeace (and other NGOs) meet with the GMO Panel of EFSA and present case studies on failures and shortcomings in risk assessment of EFSA..During the meeting the experts of EFSA reject the demand to reassess the MON863 data.

2006年2月:绿色和平(以及其他一些非政府组织)和EFSA的GMO评审会会晤,并向其陈述已经表明EFSA在风险评估方面存在缺陷与失败的案例研究。在会晤期间,EFSA的专家拒绝了重评估MON863数据的要求。

April 12, 2006: The European Commission announces that EFSA"s standards should be improved. Statistical protocols and the assessment of long term effects are explicitly

mentioned.

2006年4月12日:欧洲议会宣布EFSA应该提高标准,统计草案和长时期估计被明确提出。

March 31, 2006: Based on the previous assessment of MON863 EFSA publishes further positive opinions on three genetically modified maize plants which were produced by thecombination of MON863 with other genetically modified maize lines - MON863 x MON810, MON863 x NK603, MON863 x MON810 x NK603). According to an analysis by Greenpeace the GE hybrid maize in animal feeding studies produced significant effects related to possible health impacts.

2006年3月31日:基于先前对MON863的评估,EFSA对三种转基因玉米发表了更加肯定的评价,这三种转基因玉米的组合为:MON863 x MON810, MON863 x NK603, MON863 x MON810 x NK603。根据绿色和平的分析,GE杂交玉米饲养研究开始将显著变化和可能的健康影响联系起来。

A summary of the application can be downloaded at

申请书的摘要可以在以下网址下载:

http://www.transgen.de/pdf/zulassung/Mais/MON863_Mon863xMON810_summary.pdf

http://www.greenpeace.de/fileadmin/gpd/user_upload/themen/gentechnik/Monsanto_Rattenfuetterungsstudie.pdf

http://www.agbios.com/dbase.php?action=ShowProd&data=MON863/

http://www.cofepris.gob.mx/pyp/biotec/OMG.pdf

See footnote 2, page 27.

See footnote 2, page 23.

Assessment Report of the Robert Koch Institute in Accordance with Directive 2001/18/EC

http://www.transgen.de/pdf/zulassung/Mais/MON863_MON863xMON810_assessment.pdf

See page 10, footnote 6 above

See page 10, footnote 6 above

See page 13, footnote 6 above

See page 13, footnote 6 above

http://www.efsa.europa.eu/etc/medialib/efsa/science/gmo/gmo_opinions/381.Par.0001.File.dat/opinion_gmo_06_en1.pdf

See page 3, footnote 11 above

See page 14, footnote 11 above

See page 15, footnote 11 above

See page 15, footnote 11 above

L"expertise confidentielle sur un inquiétant maï s transgénique. Le Monde, April 23,

2004.

Hammond, B.G., Dudek, R. Lemen, J.K. & Nemeth, M.A. (2006), Results of a 90-day safety

assurance study with rats fed grain from corn borer-protected corn. Food and Chemical

Toxicology 44(7): 1092 - 1099.

http://www.greenpeace.de/themen/gentechnik/anbau_genpflanzen/artikel/monsantos_gen_mais_mon_863_studie_ueber_fuetterungsversuche_an_ratten/

Page 5 of 6

http://europa.eu/rapid/pressReleasesAction.do?reference=IP/05/793&format=HTML&aged=0&language=EN&guiLanguage=en

Full information about the written statement is only given from Greenpeace upon request

Evaluation of the report on a Subchronic Toxicity Study with Mon863 Maize. Report for the

Federal Ministry for Health and Women, 70420/0166-IB/B/12/2005. (Full information from

Greenpeace only upon request.

http://europa.eu/rapid/pressReleasesAction.do?reference=PRES/05/258&language=en

http://www.greenpeace.de/fileadmin/gpd/user_upload/themen/gentechnik/MON_863_French_report_statistics.pdf

http://europa.eu.int/eur-lex/lex/LexUriServ/site/en/oj/2006/l_034/l_03420060207en00260028.pdf

http://www.efsa.europa.eu/de/stakeholder_stakeholder/technical_meetings.html

http://europa.eu/rapid/pressReleasesAction.do?reference=IP/06/498&format=HTML&aged=1&language=EN&guiLanguage=en

http://www.efsa.europa.eu/etc/medialib/efsa/science/gmo/gm_ff_applications/more_info/505.Par.0009.File.dat/gmo_ov_op3_en1.pdf

http://www.efsa.europa.eu/etc/medialib/efsa/science/gmo/gm_ff_applications/more_info/703.Par.0009.File.dat/gmo_ov_op6_en1.pdf

http://www.efsa.europa.eu/etc/medialib/efsa/science/gmo/gm_ff_applications/more_info/720.Par.0010.File.dat/gmo_ov_op7_en1.pdf

http://www.greenpeace.de/fileadmin/gpd/user_upload/themen/gentechnik/greenpeace_mon863_mon810_hybrid_03.pdf

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