翻譯：MON863-有計劃的欺騙

這是綠色和平組織整理的關于孟山都公司在歐洲獲得MON863轉基因玉米生產許可的進程表，期間呈現了歐洲許多科學家的反對之聲，但最終抵不過歐洲議會等精英集團的操縱。逐段翻譯在這里，歡迎大家指正。

The MON863 case - a chronicle of systematic deception

MON863——有計劃的欺騙史

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：孟山都公司向德國當局提交了向歐盟引進轉基因玉米MON863的申請。這項提案中包括一個90天飼鼠試驗研究。

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是一種可以產生Bt毒素的轉基因玉米，這種毒素是delta內毒素Cry3Bb1的變體，而Cry3Bb1則來自于蘇云金桿菌。這項轉基因操作是為了使玉米植株對抗一種叫做玉米蟲（侵害玉米根須）的害蟲。

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和其他已經上市的Bt毒素轉基因玉米（如MON810，Bt11，Bt176）的不同之處在于，它不僅可生成一種叫做Cry1Ab的人造毒素，這種毒素可以使玉米對抗歐洲玉米蛀蟲，它還可以生成人造Cry3Bb1毒素。此外，MON863還含有一種抗菌基因標記。

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.

在歐盟之外，MON863獲得了在美國和加拿大種植的許可，還在澳大利亞、中國、日本、韓國、墨西哥、菲律賓和臺灣獲得了用做食物和飼料的生產許可。

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”.

基于申請書中提到的90天飼鼠試驗，孟山都認為：“觀測的毒物學指標有存活數、臨床癥狀、體重變化、進食量、臨床病理學、臟器重量以及宏觀病理學。沒有測試數據能夠表明老鼠在上述毒物學指標上表現出了變化。”

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..

在孟山都提出的飼鼠試驗研究報告中我們會發現一個令人疑惑的事實，孟山都一方面聲明該項研究是由第三方公司（Covance實驗室）完成的，但數據的統計分析卻又是由孟山都自己完成的。

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

Commission du GÃ©nie BiomolÃ©culaire) raise critical questions regarding the

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

2002年9月：法國基因工程委員會（CGB）的專家就該飼鼠試驗得出的毒理學數據向孟山都提出嚴重質疑。

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：德國主管部門發布了他們對MON863申請的評估報告。該報告認為MON863玉米所產生的Cry3Bb1毒素的氨基酸序列和另一些毒素相似，特別是，和bifermentans梭菌、Caenorhabditis elegans、cholerae霍亂菌以及popilliae桿菌相似。考慮到人類和動物的健康問題，這些相似點是亟需重視的。盡管發現了與其他毒素存在相似之處，德國當局并沒有深入調查90天飼鼠試驗，因此也就沒有確定是否對哺乳動物有毒性影響。相反，德國當局把這些相似點解釋為“由于缺乏哺乳動物中毒報告，因此這些相似之處在生物學上是無關的”

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天飼鼠試驗中，老鼠的血液出現了顯著的變化，德國當局的評估報告中是這樣說的：“從這個詳細的研究可以推斷，即使經過長時期的MON863玉米喂食，也不會看到有害的影響。”這份德國報告沒有提到任何有意義的發現，除了大段重復孟山都的結論“…在試驗組和對照組的比較中，沒有發現生物學上不同影響…”（注：control group，試驗中的控制組，不做任何實驗處理，用作與試驗組對照，也譯為對照組。）

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

2003年6月：法國基因工程委員會（CGB）以微弱多數通過了MON863的測試結果。

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：法國基因工程獨立研究委員會（CRIIGEN）控告法國檔案管理局要求給出CGB的報告原文，該報告曾提到在飼鼠試驗引起老鼠出現顯著的健康變化。法國當局宣布該報告內容保密，但CRIIGEN勝訴并把該報告交給了記者。（見后）

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：歐洲食品安全局（EFSA）發布了其對孟山都MON863申請的評議。在其結論中，EFSA的專家聲稱：“90天飼鼠試驗的結果不能表明MON863和MON810飼養造成了有害影響，因此全體評審員認為不需要考慮安全問題”

在這份評議中，EFSA提到了在飼鼠試驗中發現的顯著差異：“在血液指標上觀察到了一些變化，包括白細胞總量、淋巴球和嗜堿細胞總量。”但是EFSA以一種無所謂的語氣（general statement）說道：“這些不同并無生物學上的意義，因為它們處于對照組的標準差變化范圍之內。”

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對飼鼠試驗中老鼠腎臟重量的顯著變化也輕描淡寫：“總的結論是腎重的變化與喂食MON863并無關系，因為腎重和體重有關，也和腦重有關。”

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討論了在老鼠腎臟觀察到的微生物病理學變化，“然而，和那些喂食非轉基因普通玉米的對照組老鼠比較，喂食33%MON863玉米飼料的老鼠出現了腎臟礦物質含量指標的明顯下降。我們認為這些發現并不涉及MON863的安全性問題”

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的報告原文后，法國報紙Le Monde披露了MON863丑聞。新聞界掩飾了喂食MON863后老鼠在血液中出現的顯著變化，并顯示CGB的專家已經考慮到了安全問題。

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

2004年5月：綠色和平要求德國當局給出MON863飼鼠試驗的原始數據。

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：孟山都拒絕披露數據，只提供一份簡短的對已挑選指標的后續分析作為對德國當局的回復。

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要求法國農業部取得關于MON863玉米、NK603玉米、Bt11玉米和GT73油菜籽的毒理學飼鼠試驗的原始數據。

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：法國農業部聲明毒理學測試數據保密。

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：德國當局宣布飼鼠試驗數據應當交給綠色和平。孟山都反對德國當局的決定并上訴到科隆行政法院（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（孟山都的研究員）在《食品與化學》雜志（Food and Chemical Toxicology）上發表了一份對飼鼠試驗數據的深入評估報告。數據在2006年發布。在他的結論中作者聲稱：“歐洲食品安全局（EFSA）評審委員會的報告很好地抓住了該研究的優勢。EFSA認為90天飼鼠試驗的結果并不表明老鼠出現的有害反應是由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：科隆行政法院判決孟山都將飼鼠試驗研究數據交給綠色和平。

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：德國門斯特高等行政法院重申，飼鼠試驗數據應該交給綠色和平。綠色和平隨即在網上發布了數據全文（超過1000頁）。

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：歐盟環境部長委員會投票決定是否給予MON863作為動物飼料的許可。大部分官員投了棄權票或者反對票。由于無論反對還是贊同都沒有達到有效多數，因此該申請的最終決定權交給了歐洲議會。

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：漢堡大學的一位生物統計學專家給綠色和平發來一份手寫的聲明，指出孟山都飼鼠試驗研究中數據統計存在問題。該研究者說：“研究中確實發現了顯著差異，之后卻被定為不相關。（這就好比一名射手先朝墻上開槍再畫靶圈，他就永遠命中紅心了。）”

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：一份為澳大利亞政府準備的秘密報告指出，“對研究完全進行重新評估是必要的，但由于其設計和方法本身有缺陷，所以必須重做一次實驗”。

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：歐盟農業部長委員會投票決定是否給予MON863玉米以食物生產許可。由于反對和贊同都未能達到有效多數，因此最終決定權交給了歐洲議會。

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.

就在歐洲農業部長會議舉行前，法國CRIIGEN的研究者發表了對孟山都飼鼠試驗數據進行檢驗后得到的首批發現，在這次研究中，所有孟山都數據被重新整理并采用了全面的統計分析。報告顯示“清楚表明孟山都在統計上存在嚴重問題”。CRIIGEN呼吁對飼鼠試驗的所有數據徹底進行重新檢驗。

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：盡管有歐盟成員國與歐盟成員國議會的擔憂，有綠色和平的10000份網絡團體的抗議，歐盟委員會批準了由MON863玉米制成的食物或食物成分進入歐洲市場的許可。

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：綠色和平（以及其他一些非政府組織）和EFSA的GMO評審會會晤，并向其陳述已經表明EFSA在風險評估方面存在缺陷與失敗的案例研究。在會晤期間，EFSA的專家拒絕了重評估MON863數據的要求。

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:歐洲議會宣布EFSA應該提高標準，統計草案和長時期估計被明確提出。

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：基于先前對MON863的評估，EFSA對三種轉基因玉米發表了更加肯定的評價，這三種轉基因玉米的組合為：MON863 x MON810, MON863 x NK603, MON863 x MON810 x NK603。根據綠色和平的分析，GE雜交玉米飼養研究開始將顯著變化和可能的健康影響聯系起來。

A summary of the application can be downloaded at

申請書的摘要可以在以下網址下載：

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 13, footnote 6 above