“華中農(nóng)業(yè)大學(xué)彭東海等人用轉(zhuǎn)基因Bt制作的BMB696B粉劑持續(xù)口服14天急性與28天亞急性毒理學(xué)動物實(shí)驗(yàn)研究論文”是先正達(dá)向歐盟食品安全機(jī)構(gòu)EFSA提交的轉(zhuǎn)基因玉米MIR162“食用安全性”重要依據(jù)。“先正達(dá)轉(zhuǎn)基因玉米MIR162表達(dá)的Vip3Aa20殺蟲蛋白”與“轉(zhuǎn)基因Bt制作的BMB696B粉劑”明顯“實(shí)質(zhì)不等同”,奧地利衛(wèi)生部為此向歐洲食品安全機(jī)構(gòu)提交的評審意見對先正達(dá)舉證該項(xiàng)毒理學(xué)動物實(shí)驗(yàn)作為轉(zhuǎn)基因玉米MIR162“食用安全性”依據(jù)的科學(xué)性與嚴(yán)謹(jǐn)性提出質(zhì)疑。歐洲食品安全機(jī)構(gòu)也確：“同意彭東海等人的研究論文不足以證實(shí)轉(zhuǎn)基因玉米MIR162中表達(dá)的Vip3Aa20蛋白的安全性。”【評論：對張啟發(fā)團(tuán)隊(duì)和中國農(nóng)業(yè)大學(xué)食品科學(xué)與營養(yǎng)工程學(xué)院院長羅云波、黃昆侖教授對轉(zhuǎn)基因Bt殺蟲蛋白"灌胃一次觀察七天毒理學(xué)試驗(yàn)"，奧地利衛(wèi)生部不知會如何評價(jià)?】

　　Application EFSA-GMO-DE-2010-82 (Maize MIR162)

　　申請編號：EFSA-GMO-DE-2010-82(轉(zhuǎn)基因玉米MIR162)

　　ANNEX G Comments and opinions submitted by MemberStates during the three-month consultation period

　　附件G 成員國在三個(gè)月咨詢期內(nèi)提交的評論與意見

　　http://registerofquestions.efsa.europa.eu/roqFrontend/?wicket:interface=:0:1:::

　　Austria Federal Ministry of Health

　　奧地利聯(lián)邦衛(wèi)生部

　　Regarding D, 07.08 Toxicology

　　關(guān)于D, 07.08毒理學(xué)

　　On the paperof Peng et al. 2007 (Appendix 36): Acute oral toxicity study: The authorsperformed an acute oral toxicity study employing fifty young adult (five tosix-week-old) Wistar (25 males and 25 females) rats. The animals received soliddiet and tap water ad libitum during the experiments. The test material,BMB696B powder preparation, was suspended in distilled water and administeredorally at doses of 500, 1250, 2500 and 5000 mg/kg bw by oral gavage. Controlgroups received distilled water instead. Consecutive observation period was 15days. No abnormal clinical signs or abnormal physiological activities werereported both in all verum groups and in the control. The body weights, bodyweight gains of the rats treated with the BMB696B powder preparation showed nosignificant changes compared with those of the control group. At necropsy, nogross histopathological alterations could be found in all tested animals and inthe control group. Therefore, the authors conclude that, since even the highdose of 5000 mg/kg bw did not induce any deaths or significant toxic symptomsin their study, the oral acute toxicity of BMB696B powder preparation could beconsidered as unclassified. The verbalisations of the authors were sometimesmisleading and only interpretable with in-depth knowledge of toxicological testprocedures (obviously because the English language is not the mother tongue ofthe authors).

　　(譯注：華中農(nóng)業(yè)大學(xué))彭東海等2007年的論文(附件36)：急性毒理學(xué)研究：該項(xiàng)研究的作者們做了急性口服毒理學(xué)研究，使用五十只年輕的(5-6周年齡)Wistar(25只雄鼠與25只雌鼠)大鼠。實(shí)驗(yàn)期間，對這些動物服用了隨意量固態(tài)飲食與自來水。試驗(yàn)材料，BMB696B粉狀配制物，懸浮在蒸餾水中，以500、1250、2500與5000 mg/kg 體重劑量口服添喂。持續(xù)觀察期為15天。對所有處理組與對照組都沒有報(bào)告異常臨床跡象或者異常生理活動。服用BMB696B配制物老鼠的體重、體重增加率，與對照組相比，沒顯示顯著變化。驗(yàn)尸中，在所有試驗(yàn)動物與對照組中沒能夠發(fā)現(xiàn)任何總體組織病理學(xué)改變。該項(xiàng)研究的作者們因此結(jié)論，在他們的研究中，即便高劑量的5000mg/kg體重也未能誘發(fā)任何死亡或者顯著毒性癥狀，BMB696B粉狀配制物的口服劑型毒性可以考慮為不分類(無毒)。作者們的詞匯有時(shí)造成誤導(dǎo)，只有對毒理學(xué)試驗(yàn)程序深入知識才能解釋(顯然因?yàn)橛⑽牟皇亲髡邆兊哪刚Z)。

　　No detaileddata were provided. Somewhat peculiar are the uncommonly small deviations inbody weights and body weight gains listed within all groups (partly only a fewpercents during the whole observation period).

　　該項(xiàng)研究沒有提供詳細(xì)數(shù)據(jù)。有點(diǎn)奇怪的是，所有組內(nèi)都列出了身體重量和體重增長率非同尋常的小偏差(整個(gè)觀察期間部分僅有百分之幾)。

　　Subacute oraltoxicity study:

　　(該項(xiàng)研究包括的第二項(xiàng))亞急性口服毒理學(xué)研究

　　The subacutetoxicity study involved oral administration of BMB696B powder preparation atdoses of 0, 200, 1000 and 5000 mg/kg bw per day given to both male and femaleWistar rats (six-week old, five animals per group) for 28 consecutive days. Thetest material was suspended in distilled water; the control received onlydistilled water.

　　亞急性毒理學(xué)研究涉及每天對雄性與雌性Wistar大鼠(6周年齡，每組5只)口服0、200、1000與5000 mg/kg體重劑量的BMB696B粉狀配制物，連續(xù)28天。試驗(yàn)材料懸浮在蒸餾水中;對照組僅服用蒸餾水。

　　Except forsome minor non-dose-dependent clinical signs of single animals, noabnormalities and no obvious signs of toxicity or change in behaviouralpatterns or other physiological activities could be seen. Some haematologicaland blood chemistry values differed significantly from control in some verumgroups but the events were isolated and not dose-dependent. At autopsy,macroscopic observation of the organs did not show any change due to treatmentwith BMB696B powder preparation. Gross necropsy and pathological examination oftreated rats did not reveal any abnormality in morphology of lungs, heart,spleen, liver and kidney. Thus, the authors conclude that BMB696B administeredto rats even at a dose of 5000 mg/kg bw per day led to no significanttoxicological changes.

　　除了個(gè)別動物中某些次要的非劑量依賴臨床信號，沒有異常的與明顯的毒性信號，也沒看到行為變化或者其他的生理活動。在某些處理組中，某些血液學(xué)與血液化學(xué)指標(biāo)值與對照組顯著不同，但是這樣的事件是孤立的與非劑量依賴。尸檢中，對器官的宏觀觀察沒有顯示與服用BMB696B粉狀配制物相關(guān)的任何改變。對處理組大鼠的尸體剖檢總值和病理檢查，沒有揭示肺臟、心臟、脾臟、肝臟與腎臟任何形態(tài)學(xué)異常。該項(xiàng)研究的作者因此結(jié)論，即便每天服用5000 mg/kg體重的量也沒有導(dǎo)致顯著毒理學(xué)變化。

　　Based on theseresults, the no adverse effect level of the vip3Aa7 GM B. thuringiensis BMB696Bwould be higher than 5000 mg/kg bw per day. Therefore, they argue the vip3Aa7GM B. thuringiensis to be safe to rodents and could be considered as a safebio-pesticide for future use.

　　基于這些結(jié)果，vip3Aa7轉(zhuǎn)基因Bt BMB696B的“沒有危害影響水平”高于每天服用5000 mg/kg體重。因此，該項(xiàng)研究的作者們辯稱vip3Aa7轉(zhuǎn)基因Bt BMB696B對脊椎動物安全，也可以考慮為未來使用的安全的生物殺蟲劑。

　　For thesubacute study some more data were provided than with the acute toxicity study,but likewise no details of important toxicological parameters, for instancelists of pathology/histopatholgy evaluations, were given.

　　對于亞急性研究，比急性毒性研究提供了一些更多的數(shù)據(jù)，但是與畸形毒性研究一樣，沒有提供重要毒理學(xué)指標(biāo)的細(xì)節(jié)，例如沒有給出病理學(xué)/病理變化評估。

　　[Appendix 36.

　　AdditionalInformation provided to Applications EFSA-GMO-DE-2009-66 and -67 for import anduse of genetically modified stacked Bt11 x MIR162 x MIR604 x GA21 maize andBt11 x MIR162 x GA21 maize under Regulation (EC) No 1829/2003, submitted on 16December 2009. Dossier EFSA/GMO/DE/2010/82.

　　法規(guī)(EC) No1829/2003項(xiàng)下2009年12月16日對進(jìn)口與使用轉(zhuǎn)基因多重基因Bt11 x MIR162x MIR604 x GA21玉米與Bt11 x MIR162 x GA21玉米申請EFSA-GMO-DE-2009-66 與-67對提交的進(jìn)一步信息。檔案EFSA/GMO/DE/2010/82。

　　Peng, D.,Chen, S., Ruan, L., Li, L., Yu, Z. und Sun, M. (2007). Safety assessment oftransgenic Bacillus thuringiensis with VIP insecticidal protein gene by feedingstudies. Food Chem Toxicol 45(7): 1179-1185.]

　　studies. FoodChem Toxicol 45(7): 1179-1185.]

　　彭東海、孫明等。通過喂養(yǎng)研究對VIP殺蟲蛋白基因的轉(zhuǎn)基因Bt的安全性評估。食物化學(xué)毒理學(xué)45(7):1179-1185。】

　　EFSA GMO PanelResponse:

　　歐洲食品安全機(jī)構(gòu)轉(zhuǎn)基因?qū)＜医M的回應(yīng)：

　　As furtherexplained in the scientific opinion the EFSA GMO Panel agrees with Austria onthe inadaquacy of the publication by Peng et al. to prove the safety of theVip3Aa20 expressed in maize MIR162. Therefore, the EFSA GMO Panel requested a28-day oral toxicity study in rodents with the purified Vip3Aa20 protein. Fordetails see section 5.1.3.2 of the scientific opinion.

　　如《科學(xué)意見》中進(jìn)一步解釋的那樣，歐洲食品安全機(jī)構(gòu)轉(zhuǎn)基因?qū)＜医M同意彭東海等人的研究論文不足以證實(shí)轉(zhuǎn)基因玉米MIR162中表達(dá)的Vip3Aa20蛋白的安全性。歐洲食品安全機(jī)構(gòu)轉(zhuǎn)基因?qū)＜医M因此要求進(jìn)一步用純Vip3Aa20蛋白對脊椎動物進(jìn)行了一項(xiàng)28天口服毒理學(xué)研究。關(guān)于進(jìn)一步細(xì)節(jié)，參看《科學(xué)意見》第5.1.3.2節(jié)。

　　奧地利衛(wèi)生部揭轉(zhuǎn)基因玉米MIR162大鼠90天試驗(yàn)惡性腫瘤

　　作為向歐洲食品安全機(jī)構(gòu)(EFSA)提供轉(zhuǎn)基因玉米MIR162“食用安全性”最為關(guān)鍵性依據(jù)，先正達(dá)提交了一篇未經(jīng)同行審查也沒公開發(fā)表的令人質(zhì)疑《轉(zhuǎn)基因玉米MIR162谷物90天全食品安全性老鼠試驗(yàn)》報(bào)告。奧地利衛(wèi)生部揭露該篇毒理學(xué)試驗(yàn)報(bào)告暴露了以下嚴(yán)重問題:在喂養(yǎng)含10.0%轉(zhuǎn)基因玉米MIR162陽性飲食的一只雄鼠的腎上腺中確診了一個(gè)皮質(zhì)腺瘤，在喂養(yǎng)含41.5%轉(zhuǎn)基因玉米MIR162陰性對照非轉(zhuǎn)基因玉米一只雌鼠的陰蒂腺還確證了一個(gè)腺瘤。在喂養(yǎng)41.5%轉(zhuǎn)基因玉米MIR162陽性谷物試驗(yàn)組還早期記錄了一只雌鼠肝惡性淋巴瘤。先正達(dá)強(qiáng)調(diào)：這些問題“在性質(zhì)上具有自發(fā)性質(zhì)而且與喂養(yǎng)的飲食中的轉(zhuǎn)基因玉米MIR162谷物無關(guān)”予以排除!奧地利衛(wèi)生部強(qiáng)調(diào)：“至于對轉(zhuǎn)基因一般性應(yīng)用而言，通常的預(yù)防性聲明在這里也適用：鑒于給出的研究體系及其設(shè)計(jì)，對長期性(特別對食物而言)、生殖性或者發(fā)育性的影響，這些研究未能提供最終證據(jù)。”EFSA全然忽略奧地利衛(wèi)生部提出的問題，反而武斷決定：“依據(jù)適用的歐洲食品安全機(jī)構(gòu)指導(dǎo)原則，...對于Vip3Aa20蛋白的長期性、生殖性與發(fā)育性影響的特定信息不再要求。”【評論：向先正達(dá)轉(zhuǎn)基因玉米MIR162頒“安全證書”農(nóng)業(yè)部必須公布“2011年指定農(nóng)業(yè)部轉(zhuǎn)基因生物食用安全監(jiān)督檢驗(yàn)測試中心(天津)進(jìn)行MIR162玉米及常規(guī)對照玉米90天大鼠喂養(yǎng)試驗(yàn)”報(bào)告原件的掃描件!】

　　Application EFSA-GMO-DE-2010-82 (Maize MIR162)

　　申請編號：EFSA-GMO-DE-2010-82（轉(zhuǎn)基因玉米MIR162）

　　ANNEX G Comments and opinions submitted by MemberStates during the three-month consultation period

　　附件G成員國在三個(gè)月咨詢期內(nèi)提交的評論與意見

　　http://registerofquestions.efsa.europa.eu/roqFrontend/?wicket:interface=:0:1:::

　　AustriaFederal Ministry of Health

　　奧地利聯(lián)邦衛(wèi)生部

　　Onthe 90-day whole food safety study (FROM CBI: Appendix 28 ):

　　關(guān)于90天全食品安全性研究(自CBI:附件28)

　　Itwas not confirmed analytically that the active principles could be actuallydetected in the diet. The investigators report that statistical evaluationallowing for pre-experimental body weight (adjusted means) indicated adjustedbody weights of females fed diet containing 41.5% Event MIR162 positive maizegrain having been occasionally statistically significantly lower than weightsof the corresponding control group, particularly during the latter part of thestudy. From the given data, only some increase in body weight of the femalehigh dose verum group could be verified.

　　未分析證實(shí)，飲食中實(shí)際上是否能檢測到活性成分。調(diào)查者報(bào)告，統(tǒng)計(jì)學(xué)評價(jià)允許的試驗(yàn)前體重(經(jīng)調(diào)整名義體重)顯示，喂養(yǎng)含41.5%轉(zhuǎn)基因玉米MIR162陽性飲食的雌鼠體重有時(shí)比對應(yīng)對照組統(tǒng)計(jì)顯著低，特別在試驗(yàn)的后期。從提供的數(shù)據(jù)看，僅高劑量組雌鼠中可以證明體重有某些增加。

　　Infemales, basophil count was statistically significantly lower for groups feddiets containing 10.0 and 41.5% Event MIR162 positive transgenic maize graincompared to the corresponding control groups. When the high control values wereexcluded the basophil count was no longer statistically significantly lower forthe group fed diet containing 41.5% Event MIR162 positive transgenic maizegrain. But it has to be mentioned that for the low dose verum group thedecreased basophil count remained statistically significant compared to thecorresponding control group, and with the high dose verum groupnon-significance as against the corresponding control group could only beachieved by deleting values of three (1/4) control animals. Moreover, a trendin the direction of decreased basophil counts within the verum groups stillremained. A decreased percentage of basophils may be due to an acute allergicreaction.

　　喂養(yǎng)10.0%與41.5%轉(zhuǎn)基因玉米MIR162陽性處理組的雌鼠，與對應(yīng)對照組比較，嗜堿細(xì)胞計(jì)數(shù)統(tǒng)計(jì)顯著更低。高劑量對照值排除時(shí)，41.5%轉(zhuǎn)基因玉米MIR162陽性處理組的嗜堿細(xì)胞計(jì)數(shù)就不再統(tǒng)計(jì)顯著更低。但是應(yīng)當(dāng)提出，低劑量(10.0%)試驗(yàn)組嗜堿細(xì)胞計(jì)數(shù)統(tǒng)計(jì)顯著低與對應(yīng)對照組，而高劑量(41.5%)嗜堿細(xì)胞計(jì)數(shù)并不統(tǒng)計(jì)顯著低與對應(yīng)對照組僅能由于刪除了對照組中三只鼠(1/4)的值。此外，處理組中嗜堿細(xì)胞計(jì)數(shù)減少的趨勢依然存在。嗜堿細(xì)胞計(jì)數(shù)減少的百分百可能由于畸形過敏性反應(yīng)。

　　At aninclusion level of 10.0% Event MIR162 positive transgenic maize grain, plasmaalkaline phosphatase was statistically significantly higher in males comparedto the corresponding control group. However, the difference did not remainstatistically significant after the exclusion of a single exceptionally highvalue. Apart from the fact that normally the deletion of "out-liers"leads to a "sharpening" of statistical significance(i.e.non-significant differences sometimes become significant because of thediminution of the standard deviation) and not vice versa, the seen effectposing no significance under isolated consideration gains in importance if theresults of the subacute study performed by Peng et al. (2007) are taken intoconsideration: the ALP (alkaline phosphatase) in 5000 mg/kg female group wassignificantly higher.

　　在含10.0%水平轉(zhuǎn)基因玉米MIR162陽性中，與對應(yīng)對照組相比，雄鼠中的堿性磷酸酶統(tǒng)計(jì)顯著更高。然而，在排除單獨(dú)一個(gè)特別高值以后，這種差別不再維持統(tǒng)計(jì)顯著。除了正常地刪除導(dǎo)致使統(tǒng)計(jì)顯著“更突出”的“超出者”(即，減少標(biāo)準(zhǔn)偏差使非顯著有時(shí)成為顯著)，而非反之亦然，使所看到的影響在孤立考慮收益的重要性下沒有意義，如果Penget al. (2007)進(jìn)行的亞急性研究的結(jié)果考慮在內(nèi)：5000mg/kg雌鼠組中的堿性磷酸酶(ALP)顯著更高。

　　Twoinstances of benign tumours were observed. A cortical adenoma was diagnosed inthe adrenal gland of one male animal fed diet containing 10.0% Event MIR162positive maize grain, and an adenoma was also diagnosed in the clitoral glandof a female animal fed diet containing 41.5% Event MIR162 negative control,non-transgenic maize grain. One early case of malignant lymphoma involving onlythe liver was also recorded in one female animal fed diet containing 41.5%Event MIR162 positive maize grain. These tumours the authors considered to bespontaneous in nature and unrelated to the administration of Event MIR162 maizegrain in diets.

　　觀察到兩個(gè)良性腫瘤實(shí)例。在喂養(yǎng)含10.0%轉(zhuǎn)基因玉米MIR162陽性飲食的一只雄鼠的腎上腺中確診了一個(gè)皮質(zhì)腺瘤，在喂養(yǎng)含41.5%轉(zhuǎn)基因玉米MIR162陰性對照非轉(zhuǎn)基因玉米顧問飲食的一只雌鼠的陰蒂腺還確證了一個(gè)腺瘤。在喂養(yǎng)41.5%轉(zhuǎn)基因玉米MIR162陽性谷物試驗(yàn)組中早期還記錄了一只雌鼠的肝惡性淋巴瘤。試驗(yàn)研究報(bào)告的作者們認(rèn)為他們在性質(zhì)上具有自發(fā)性質(zhì)而且與喂養(yǎng)的飲食中的轉(zhuǎn)基因玉米MIR162谷物無關(guān)。

　　[Appendix28.

　　[附件28.轉(zhuǎn)基因

　　EventMIR162 maize grain 90 day whole food safety study in rats. DossierEFSA/GMO/DE/2010/82.

　　玉米MIR162谷物對大鼠的90天全食物安全性研究。文件編號：DossierEFSA/GMO/DE/2010/82.【注：未公開發(fā)布研究報(bào)告!】

　　Peng,D., Chen, S., Ruan, L., Li, L., Yu, Z. und Sun, M. (2007). Safety assessment oftransgenic Bacillus thuringiensis with VIP insecticidal protein gene by feedingstudies. Food Chem Toxicol 45(7): 1179-1185.]

　　彭東海、孫明等。通過喂養(yǎng)研究對VIP殺蟲蛋白基因的轉(zhuǎn)基因Bt的安全性評估。食物化學(xué)毒理學(xué)45(7):1179-1185。】

　　http://www.sciencedirect.com/science/article/pii/S0278691507000142

　　AustriaFederal Ministry of Health Conclusions:

　　奧地利聯(lián)邦衛(wèi)生部結(jié)論：

　　Foracute and subacute oral studies with rats fed the Vip3Aa protein, nosignificant toxicological effects up to 5000 mg/kg bw (the highest dose used)were reported by Peng et al. (2007).

　　用大鼠喂養(yǎng)Vip3Aa蛋白的急性與亞急性口服研究，Penget al. (2007)的研究論文宣稱：一直到5000mg/kg體重(使用的最高劑量)都沒有顯著毒理學(xué)影響。

　　However,being a publication in a scientific journal, the paper of Peng et al. did notcontain detailed results in that extent of making verification or evaluation ofsomeone?s own possible. Thus, detailed documentation and data would have to beprovided in order to make robust assessment on these toxicological parameters.

　　然而，作為在科學(xué)雜志上發(fā)表的文章，彭東海等人的論文沒有達(dá)到使其他人可以驗(yàn)證或者評價(jià)的足夠詳盡結(jié)果。因而，需要提供詳細(xì)的文件與數(shù)據(jù)以便能夠?qū)@些毒理學(xué)指標(biāo)做出可靠的評估。

　　Withthe results of the 90-day study with the whole MIR 162 maize grain the studyauthors were seeing no deviations or pathological changes caused by theproduct.

　　鑒于轉(zhuǎn)基因玉米MIR162全谷物90天研究的結(jié)果，該項(xiàng)研究的作者們看到MIR162玉米不造成任何偏差或者生理學(xué)改變。

　　Thisconclusion can be accepted in general with one exception, even thoughstatistically significant aberrations in the verum group are"smoothed" several times by omission of outlying values in thecontrol group or by comparison with the "historical control".

　　這個(gè)結(jié)論可以一般性的接受，但是有一個(gè)例外，即便通過排除對照組中的超量值或通過與“歷史性對照”進(jìn)行比較的方法對處理組中的畸變統(tǒng)計(jì)顯著進(jìn)行數(shù)次“平滑”處理。

　　Regardingthe basophil count in females, there was a trend in the direction of decreasecompared to the corresponding control groups.

　　關(guān)于雌鼠中的嗜堿細(xì)胞計(jì)數(shù)，與對應(yīng)對照組相比，存在著減少傾向。

　　Adecreased percentage of basophils may be due to allergic reactibility.

　　嗜堿細(xì)胞計(jì)數(shù)百分百減少可能因?yàn)檫^敏性反應(yīng)。

　　Regardingthe elevation of alkaline phosphatase, it was only sporadic, and no increase ofother organ (especially liver) damage indication enzymes (for instanceaminotransferases) could be seen.

　　關(guān)于堿性磷酸酶升高，它僅是零星的，而且未能看到其他器官(特別是肝臟)損傷指示酶(例如轉(zhuǎn)氨酶)響應(yīng)升高。

　　(FROMCBI: Appendix 28) Apart from the decreased basophil count with its possibleallergenic implication (which counts for even more, because the allergenicpotential or non-potential was elaborated only theoretically in another part ofthe dossier), from the given data no significant substantial detrimentaleffects caused by MIR162 maize or its active principle Vip3Aa protein could berecognised.

　　(從CBI：附錄28)除了降低的嗜堿細(xì)胞計(jì)數(shù)及其可能的的致敏性關(guān)聯(lián)(其計(jì)數(shù)意義更大，因?yàn)橹旅粜詽撛诨蛘卟粷撛趦H作為理論可能性在檔案另外一部分闡述)，從給出的數(shù)據(jù)來看，看不到可以承認(rèn)的轉(zhuǎn)基因玉米MIR162或其活性成分Vip3Aa蛋白造成顯著實(shí)質(zhì)性危害影響。

　　(FROM CBI: Appendix 28 ) As with applicationsof GMOs in general, the usual precautionary statement also applies in thiscase: With the given study batteries and designs, no final evidence is possiblewith reference to long-term (especially appropriate for foodstuffs),reproductive or developmental effects.

　　(從CBI：附錄28)至于對轉(zhuǎn)基因一般性應(yīng)用而言，通常的預(yù)防性聲明在這里也適用：鑒于給出的研究體系及其設(shè)計(jì)，對長期性(特別對食物而言)、生殖性或者發(fā)育性的影響，這些研究未能提供最終證據(jù)。

　　Increasedattention has to be paid to even very slight deviations from control groups indifferent parameters because of the very small concentrations/dosages of theactive principles which can be used. In addition, the general statements givenunder Applications for authorisation of genetically modified plants withcombined traits Bt11xMIR162xMIR604xGA21 and Bt11xMIR162xGA21 - according toSection D.7.8 EFSA GMO guidance document (EFSA 2006) and 7.2 of the UpdatedGuidance Document (EFSA 2008) for the Risk Assessment of Genetically ModifiedPlants and Derived Food and Feed, respectively - apply.

　　對于不同指標(biāo)中與對照組相比的即便非常微小的偏差應(yīng)當(dāng)給予更多注意，因?yàn)樗褂玫幕钚晕镔|(zhì)的非常小濃度/劑量。此外，對于申請獲得授權(quán)的Bt11xMIR162xMIR604xGA21與Bt11xMIR162xGA21多重形狀轉(zhuǎn)基因作物的總得聲明 -- 依據(jù)歐洲食品安全機(jī)構(gòu)轉(zhuǎn)基因指導(dǎo)文件(EFSA2006)第D.7.8節(jié)，以及對轉(zhuǎn)基因作物及其加工食品與飼料風(fēng)險(xiǎn)評估更新指導(dǎo)文件(EFSA2008)第7.2節(jié)，也適用。

　　[Appendix28.

　　[附錄28.

　　EventMIR162 maize grain 90 day whole food safety study in rats. DossierEFSA/GMO/DE/2010/82.

　　轉(zhuǎn)基因玉米MIR162谷物90天全食品安全性老鼠試驗(yàn)。檔案EFSA/GMO/DE/2010/82

　　EFSA(2006). Guidance document of the Scientific Panel on Genetically ModifiedOrganisms for the risk assessment of genetically modified plants and derivedfood and feed. The EFSA Journal 99: 1-100. EFSA (2008).

　　歐洲食品安全機(jī)構(gòu)(2006)。轉(zhuǎn)基因生物科學(xué)專家組對轉(zhuǎn)基因作物及其加工食品與飼料風(fēng)險(xiǎn)評估指導(dǎo)文件。歐洲食品安全機(jī)構(gòu)雜志99：1-100.EFSA (2008)。

　　Updatedguidance document for the risk assessment of genetically modified plants andderived food and feed - draft document adopted in May 2008. The EFSA Journal727: 1-135.

　　對轉(zhuǎn)基因作物及其加工食品與飼料風(fēng)險(xiǎn)評估更新指導(dǎo)文件 --2008年5月采納的文件草案。歐洲食品安全機(jī)構(gòu)雜志727：1-135.EFSA (2008)。

　　Peng,D., Chen, S., Ruan, L., Li, L., Yu, Z. und Sun, M. (2007). Safety assessment oftransgenic Bacillus thuringiensis with VIP insecticidal protein gene by feedingstudies. Food Chem Toxicol 45(7): 1179-1185.]

　　彭東海、孫明等。通過喂養(yǎng)研究對VIP殺蟲蛋白基因的轉(zhuǎn)基因Bt的安全性評估。食物化學(xué)毒理學(xué)45(7):1179-1185。】

　　http://www.sciencedirect.com/science/article/pii/S0278691507000142

　　歐洲食品安全機(jī)構(gòu)(EFSA)對奧地利聯(lián)邦衛(wèi)生部質(zhì)疑的回復(fù)：

　　Levelsof the newly expressed proteins in the diets are given in Appendix 28.1 (withinAppendix 28, page 952). The chemical composition of the diets is given inAppendix 1 within Appendix 28. The pedigree of the maize grain used toformulate the diets is given in Table 8 of the Technical dossier. Forassessment of the observations in the 90-day study see section 5.1.3.4 of theopinion.

　　附錄28.1給出飲食中新表達(dá)的蛋白的水平(在附錄28，第952頁)。附錄28中的附錄1給出了飲食的化學(xué)成分。技術(shù)檔案表8給出了用于配制飲食的玉米谷物品種。對90天研究中的觀察的評估，參看《科學(xué)意見》第5.1.3.4節(jié)。

　　歐洲食品安全機(jī)構(gòu)(EFSA)對奧地利聯(lián)邦衛(wèi)生部結(jié)論的回復(fù)：

　　Asfurther explained in the scientific opinion the EFSA GMO Panel agrees withAustria on the inadaquacy of the publication by Peng et al. to prove the safetyof the Vip3Aa20 expressed in maize MIR162. Therefore, the EFSA GMO Panelrequested a 28-day oral toxicity study in rodents with the purified Vip3Aa20protein. For details see section 5.1.3.2 of the scientific opinion.

　　如《科學(xué)意見》中進(jìn)一步解釋的那樣，歐洲食品安全機(jī)構(gòu)轉(zhuǎn)基因生物轉(zhuǎn)基因組同意奧地利提出的意見，即彭東海等人的試驗(yàn)研究論文不足以證實(shí)轉(zhuǎn)基因玉米MIR162中表達(dá)的Vip3Aa20蛋白的安全性。歐洲食品安全機(jī)構(gòu)轉(zhuǎn)基因生物轉(zhuǎn)基因組因此要求用純Vip3Aa20蛋白對脊椎動物進(jìn)行一項(xiàng)28天口服毒性研究。對于有關(guān)細(xì)節(jié)，參看《科學(xué)意見》第5.1.3.2節(jié)。

　　Forassessment of the observations in the 90-day study see section 5.1.3.4 in theopinion.

　　對90天研究觀察的評估，參看《科學(xué)意見》第5.1.3.4節(jié)。

　　Comparativeanalyses established that no biologically relevant differences were identifiedin the compositional, agronomic or phenotypic characteristics of maize MIR162as compared with its conventional counterpart and that the composition of maizeMIR162 fell within the range of non-GM commercial varieties, except forexpressing the Vip3Aa20 and PMI proteins.

　　比較分析確立了轉(zhuǎn)基因玉米MIR162，與其傳統(tǒng)對應(yīng)品種相比，在成分、農(nóng)藝或表型特征方面，沒有發(fā)現(xiàn)生物性相關(guān)差別，而且，轉(zhuǎn)基因玉米MIR162的成分與非轉(zhuǎn)基因商業(yè)品種的范圍重疊，表達(dá)Vip3Aa20蛋白與PMI蛋白以外。

　　Basedon the compositional analysis and considering the outcomes of the 90-day ratand 42-day broiler feeding studies, no further animal safety studies arerequired in accordance with the EFSA guidance document. Furthermore, the informationprovided on the VIP protein includes a 28-day repeated dose toxicity study,which was performed on request of the EFSA GMO Panel, showed no indications ofadverse effects.

　　基于成分性分析以及考慮了90天大鼠研究與42天的肉雞喂養(yǎng)研究的結(jié)果，依據(jù)歐洲食品安全指導(dǎo)文件不要求進(jìn)一步的動物安全性研究。除此之外，對VIP蛋白提供的信息包括一項(xiàng)28天重復(fù)劑量毒理學(xué)研究，它是依據(jù)歐洲食品安全機(jī)構(gòu)轉(zhuǎn)基因生物專家組的要求進(jìn)行的，表明沒有危害性影響的跡象。

　　Inaccordance with applicable EFSA guidance the applicant submitted a 28-day oraltoxicity study with the Vip3Aa20 protein as additional information upon requestby the EFSA GMO Panel. Therefore, specific information regarding long-term,reproductive and developmental effects for Vip3Aa20 protein are not required.

　　依據(jù)適用的歐洲食品安全機(jī)構(gòu)指導(dǎo)原則，作為額外信息，申請方已經(jīng)提交了對Vip3Aa20蛋白進(jìn)行的一項(xiàng)28天口服毒理學(xué)研究。因此，關(guān)于對于Vip3Aa20蛋白的長期性、生殖性與發(fā)育性影響的特定信息不再要求。

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