1、,高文彥博士 高級研究員 行政院衛(wèi)生署食品衛(wèi)生處,基因轉(zhuǎn)殖家畜禽研發(fā)現(xiàn)況與生物安全評估研討會 財團法人動物科技研究所,基因改造食品之安全性風(fēng)險評估,世界衛(wèi)生組織(WHO): GM foods currently available on the international market have passed risk assessments and are not likely to present risks for human health. 現(xiàn)今國際市場上的基因改造食品均已通過安全風(fēng)險評估，不大可能會對人體健康導(dǎo)致危害。 - 2002年10月15日“基因改造食品常見問答20題” htt

2、p://fsf/,基因改造食品安全嗎?,簡介,2,世界上第一個. 基因改造蕃茄 1994年美國加州 FlavrSavr Tomato, Calgene Photo by Jack Dykinga. Sources ARS Photo Unit, 2001, USDA.,簡介,3,耐農(nóng)藥/抗蟲能力 (第一代),Bt抗蟲玉米,傳統(tǒng)玉米,簡介,4,(Input Traits),Source: Monsanto,黃金米可以防治維生素A缺乏癥成為健康食品,改變營養(yǎng)組成 (第二代),簡介,5,(Output Traits),複製人! 和我有什麼關(guān)係 陳文君著 泛亞 2001,我也想吃

3、!,生產(chǎn)醫(yī)藥與工業(yè)用 (第三代),簡介,6,(Output Traits),由臺灣動物科技研究所研究成功的複製豬酷比三號，八日在第三屆臺灣國際生物科技大展記者會中亮相。 酷比三號是全球第一例雙基因轉(zhuǎn)殖複製豬。 (中央社記者鄭傑文攝91.8.8),基因改造動物,簡介,7,什麼是基因改造? Genetically Modified (GM) 非傳統(tǒng)育種技術(shù) 現(xiàn)代基因工程技術(shù) 基因重組、基因轉(zhuǎn)移、基因轉(zhuǎn)殖,簡介,什麼是基因改造食品?,8,什麼是基因改造生物? Genetically Modified Organism (GMO) 利用現(xiàn)代基因工程技術(shù) 將甲生物基因轉(zhuǎn)移植入乙生物 乙生物成為GMO G

4、MO包括植物、動物、微生物,簡介,什麼是基因改造食品?,9,分三大類: 1.本身含新基因: 大豆 2.加工食品含新基因: 豆腐 3.精製純化食品不含新基因:大豆油,所有動、植物，微生物來源的食品都含有基因！,簡介,什麼是基因改造食品?,10,全球生產(chǎn)面積快速增加,簡介,(百萬公頃),11,(百萬公頃),GM作物 - 四大生產(chǎn)作物,大豆,玉米,棉花,油菜,簡介,12,GM作物 - 四大生產(chǎn)國家,簡介,13,75%耐農(nóng)藥,17%抗蟲,8%,2002年, 1%,簡介,14,Stacked traits,GM作物 二大類型(第一代),臺灣有那些 基因改造食品?,基因改造食品,簡介,15,出口美國 47

5、.13 中國大陸 8.61 阿根廷 8.58 巴西 3.86 匈牙利 2.75 進口 日本 16.40 南韓 8.61 埃及 4.95 臺灣 4.59 墨西哥 4.03 加拿大 4.00 歐盟 2.91,出口美國 28.92 巴西 15.00 阿根廷 6.01 巴拉圭 2.11 荷蘭 1.79 進口 中國大陸 10.39 荷蘭 6.02 日本 5.02 德國 4.55 墨西哥 4.51 西班牙 3.32 臺灣 2.58,玉 米,黃 豆,Sources: US Foreign Agricultural Services Production, Supply and Distribution (P

6、S354(9187):1353-4,38,星連(StarLink)玉米事件 2000年 美國、日本(臺灣) - 飼料級玉米 - 含Cry9C (Bt的一種) 疑似致過敏 (CDC證實沒有臨床過敏案例) - 全面禁止,Case Study,基因改造食品之安全性評估,39,StarLink Corn 星連玉米,不得含有: Cry9C成分 (StarLink),40,Case Study,基因改造食品之安全性評估,星連玉米(StarLink),食品安全評估 有致過敏疑慮： 模擬消化試驗 SGF stability, pH2 4hr 2. 熱穩(wěn)定試驗 90C 19 min,“There is no e

7、vidence to indicate that Cry9C is or is not a potential food allergen.” - US EPA, 2000.,SGF: Simulated Gastric Fluid(人造胃液),41,Case Study,Source: Fu, et al. 2002.,過敏性評估:消化穩(wěn)定性試驗之存疑,Case Study,42,Allergenicity: Decision Tree Approach,過敏性評估: FAO/WHO 2000 Decision Tree,43,Allergenicity: Decision Tree App

8、roach,Source of gene allergenic,Sequence Homology,Specific Serum Screen,Targeted Serum Screen,Pepsin Resistance ,Evaluation of GM canola in sheep and swine*,Agriculture and Agri-Food Canada Research Centres, Lethbridge T. A. McAllister, R. Sharma, T. Alexander, K. Stanford Lacombe M. Dugan, J. Aahlu

9、s, K. Lien,Case Study,* Presented at The 6th APEC ATCWG meeting, Taipei, 2002.,Horizontal Gene Transfer (HGT)?,47,Sheep study - long-term,48,Swine study - spleen,Detection of transgene fragments,F4,F5,F6,P1 P2 +,P1 P2 +,P1 P2 +,F7,F8,F9,F12,P1 P2 +,P1 P2 +,P1 P2 +,P1 P2 +,F3,P1 P2 +,49,Swine study -

10、 spleen,Detection of transgene fragments,50,Swine study - kidney,Detection of transgene fragments,F4,F5,F6,P1 P2 +,P1 P2 +,P1 P2 +,F7,F8,F9,F12,P1 P2 +,P1 P2 +,P1 P2 +,P1 P2 +,51,F4,F5,F6,P1 +,P1 +,P1 +,F7,F8,F9,P1 +,P1 +,P1 +,F12,P1 +,Swine study - kidney,Detection of transgene fragments,52,Conclus

11、ions - animal study,GM canola and its parental variety had the same feeding value for both lambs and swine Sheep trial Transgene not detectable in blood or tissues Swine trial Transgene fragments detected in liver and kidney,53,Horizontal Gene Transfer (HGT)?,Implications,HGT(Horizontal Gene Transfe

12、r) Frequency of such transfer,54,Horizontal Gene Transfer (HGT)?,To improve resistance of piglet to suffer from diarrhea and anemia by increase of lactoferrin concentration contained in the sow milk.2. To establish molecular pharming for mass production of pharmaceutics including human clotting fact

13、ors VIII, IX and allergic proteins such as Derp(s). 3. To generate transgenic pigs for xenotransplantation.,Purposes of Transgenic (Tg) Animals,55,Case Study,Tg gilt No. 8-3,Tg gilt No. 8-5,Tg pigs harboring both transgenes of LA- pLF &LA- hFIX genes,56,Fig. Tissue- and stage-specific expression of

14、aLA-FVIII transgene detected by RT-PCR,57,評估轉(zhuǎn)殖基因表達是否正常,“Leaky Expression?”,02/07/2003,Research Piglets Sold as Food Hard to Find, FDA Accused of Lax Biotech Regulation,WHO: 美國伊利諾大學(xué) (University of Illinois Urbana/Champaign) WHEN: 4/2001 1/2003 WHAT: 386頭 基因改造實驗乳豬 販?zhǔn)劢o肉品商,基因改造實驗動物流入食品市場,58,Case Study,I

15、. 食品安全Food Safety II. 環(huán)境生態(tài)Environmental Safety III. 社會倫理ELSI (ethical, legal, social issues) IV. 國際貿(mào)易Trade,GM作物 四大議題,59,基因改造食品與生態(tài)環(huán)境,Case Study,60,康乃爾大學(xué)John Losey (1999) 幼蟲啃囁食灑滿Bt玉米花粉的乳草(馬利筋MilkWeed) 幼蟲半數(shù)死亡,帝王蝶(黑脈金斑蝶) Monarch Butterfly,61,Case Study,Case Study,The ProdiGene Incident,62,WHO - ProdiGen

16、e Inc. (College Station, TX) WHAT - edible vaccine grown in corn WHEN - 11/13/2002 USDA investigation WHY - Contamination of 155 Acre soybeans,RESULTS: $250,000 罰鍰 + $3,000,000 USDA補償款 + $1,000,000 保證金 美國加強聯(lián)邦法規(guī): 68FR11337,一、威脅非目標(biāo)生物 二、降低生物多樣性 三、基因散佈污染生態(tài) (HGT) 四、產(chǎn)生超級抗性雜草 (HGT),基因改造食品與生態(tài)環(huán)境,63,I. 食品安全Fo

17、od Safety II. 環(huán)境生態(tài)Environmental Safety III. 社會倫理ELSI (ethical, legal, social issues) IV. 國際貿(mào)易Trade,GM作物 四大議題,64,一、動物基因在植物裡 二、科學(xué)家扮演上帝 三、違反自然 四、生命智財權(quán),基因改造食品與社會倫理,What We Could V. What We Should,65,I. 食品安全Food Safety II. 環(huán)境生態(tài)Environmental Safety III. 社會倫理ELSI (ethical, legal, social issues) IV. 國際貿(mào)易Tra

18、de,GM作物 四大議題,66,Tuesday, 13 May, 2003 US launches GM trade war The United States - and twelve other agricultural exporting nations - want the EU to repeal its five-year moratorium on GM foods, or face trade sanctions under World Trade Organisation (WTO) rules.,基因改造食品與WTO,67,世界貿(mào)易組織 (WTO) GMO 相關(guān)協(xié)定 食品衛(wèi)

19、生檢驗與動植物檢疫措施協(xié)定Sanitary and Phytosanitary Measures (SPS) 技術(shù)性貿(mào)易障礙協(xié)定 Technical Barrier to Trade (TBT),基因改造食品與WTO,68,基因改造食品成為主要議題 因為許多國家： 禁止基因改造食品 實施標(biāo)示制度,有關(guān)GMOs之文件數(shù) 年度 TBT SPS 1995 1 4 1996 2 1 199711 0 199811 5 199920 2 20001420 20012537 2002 4374 2003(1-6)1943 合計 146 186,基因改造食品與WTO,69,Cartegena Protoco

20、l on Biosafety(生物安全議定書) Article 1. Objective The objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on the co

21、nservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.,World Trade Organization (WTO) is the only international organization dealing with the global rules of trade between nations. Its main function is to ensure that trade flows as smoo