1、,高文彥博士 高級研究員行政院衛生署食品衛生處,基因轉殖家畜禽研發現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險評估,世界衛生組織(WHO): GM foods currently available on the international market have passed risk assessments and are not likely to present risks for human health. 現今國際市場上的基因改造食品均已通過安全風險評估，不大可能會對人體健康導致危害。 - 2002年10月15日“基因改造食品常見問答20題” http:
2、/www.who.int/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, CalgenePhoto by Jack Dykinga. Sources ARS Photo Unit, 2001, USDA.,簡介,3,耐農藥/抗蟲能力 (第一代),Bt抗蟲玉米,傳統玉米,簡介,4,(Input Traits),Source: Monsanto,黃金米可以防治維生素A缺乏症成為健康食品,改變營養組成 (第二代),簡介,5,(Output Traits),複製人! 和我有什麼關係 陳文君著 泛亞 2001,我也想吃!,生產醫藥
3、與工業用 (第三代),簡介,6,(Output Traits),由台灣動物科技研究所研究成功的複製豬酷比三號，八日在第三屆台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) 非傳統育種技術 現代基因工程技術 基因重組、基因轉移、基因轉殖,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) 利用現代基因工程技術 將甲生物基因轉移植入乙生物 乙生物成為GMO GMO包括植物、動
4、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,全球生產面積快速增加,簡介,(百萬公頃),11,(百萬公頃),GM作物 - 四大生產作物,大豆,玉米,棉花,油菜,簡介,12,GM作物 - 四大生產國家,簡介,13,75%耐農藥,17%抗蟲,8%,2002年, 4hr2. 熱穩定試驗 90C 19 min,“There is no evidence to indicate that Cry9C is or is not a p
5、otential 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 Approach,Source of gene allergenic,Sequence Homology
6、,Specific Serum Screen,Targeted Serum Screen,Pepsin Resistance & Animal Models,High +/+ +/- -/- LowProbability of Allergenicity,Likely allergenic,Sequence Homology,Yes,Yes,No,No,No,No,Yes,No,過敏性評估: FAO/WHO 2001 Decision Tree,44,神秘DNA事件(August 2001) Molecular Characterization of the genetic modificat
7、ion,Case Study,Windels P. et al. (2001),45,- 2001.4.2. - 種植基因改造油菜花 (GM Canola)智財權爭議:孟山都生物科技種子訴訟糾紛 加拿大農夫敗訴！,Monsanto vs. Percy Schmeiser,Horizontal Gene Transfer (HGT)?,(產品: 加拿大芥花油),Case Study,46,* http:/www.fct-cf.gc.ca ; http:/,Evaluation of GM canola in sheep and swine*,Agriculture and Agri-Food C
8、anada Research Centres, LethbridgeT. A. McAllister, R. Sharma, T. Alexander, K. Stanford LacombeM. Dugan, J. Aahlus, 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 f
9、ragments,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 - 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,F
10、6,P1 +,P1 +,P1 +,F7,F8,F9,P1 +,P1 +,P1 +,F12,P1 +,Swine study - kidney,Detection of transgene fragments,52,Conclusions - animal study,GM canola and its parental variety had the same feeding value for both lambs and swine Sheep trialTransgene not detectable in blood or tissuesSwine trialTransgene fra
11、gments detected in liver and kidney,53,Horizontal Gene Transfer (HGT)?,Implications,HGT(Horizontal Gene Transfer) 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
12、 sow milk.2. To establish molecular pharming for mass production of pharmaceutics including human clotting factors 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
13、,Tg pigs harboring both transgenes of LA- pLF &LA- hFIX genes,56,Fig. Tissue- and stage-specific expression of aLA-FVIII transgene detected by RT-PCR,57,評估轉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 (Univers
14、ity of Illinois Urbana/Champaign) WHEN: 4/2001 1/2003 WHAT: 386頭 基因改造實驗乳豬 販售給肉品商,基因改造實驗動物流入食品市場,58,Case Study,I. 食品安全Food SafetyII. 環境生態Environmental SafetyIII. 社會倫理ELSI (ethical, legal, social issues)IV. 國際貿易Trade,GM作物 四大議題,59,基因改造食品與生態環境,Case Study,60,康乃爾大學John Losey (1999) 幼蟲啃囁食灑滿Bt玉米花粉的乳草(馬利筋Mil
15、kWeed) 幼蟲半數死亡,帝王蝶(黑脈金斑蝶) Monarch Butterfly,61,Case Study,Case Study,The ProdiGene Incident,62,WHO - ProdiGene Inc. (College Station, TX) WHAT - edible vaccine grown in corn WHEN - 11/13/2002 USDA investigationWHY - Contamination of 155 Acre soybeans,RESULTS:$250,000 罰鍰 + $3,000,000 USDA補償款 + $1,000,
16、000 保證金美國加強聯邦法規: 68FR11337,一、威脅非目標生物二、降低生物多樣性三、基因散佈污染生態 (HGT)四、產生超級抗性雜草 (HGT),基因改造食品與生態環境,63,I. 食品安全Food SafetyII. 環境生態Environmental SafetyIII. 社會倫理ELSI (ethical, legal, social issues)IV. 國際貿易Trade,GM作物 四大議題,64,一、動物基因在植物裡二、科學家扮演上帝三、違反自然四、生命智財權,基因改造食品與社會倫理,What We Could V. What We Should,65,I. 食品安全Fo
17、od SafetyII. 環境生態Environmental SafetyIII. 社會倫理ELSI (ethical, legal, social issues)IV. 國際貿易Trade,GM作物 四大議題,66,Tuesday, 13 May, 2003US launches GM trade warThe United States - and twelve other agricultural exporting nations - want the EU to repeal its five-year moratorium on GM foods, or face trade sa
18、nctions under World Trade Organisation (WTO) rules.,基因改造食品與WTO,67,世界貿易組織 (WTO)GMO 相關協定食品衛生檢驗與動植物檢疫措施協定Sanitary and Phytosanitary Measures (SPS)技術性貿易障礙協定 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示制度,有關GMOs之文件數 年度 TBT SPS 1995 1 4 1996 2 1 199711 0 199811 5 199920
19、2 20001420 20012537 2002 4374 2003(1-6)1943 合計 146 186,基因改造食品與WTO,69,Cartegena Protocol on Biosafety(生物安全議定書)Article 1. ObjectiveThe 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 organism
20、s (LMOs) resulting from modern biotechnology that may have adverse effects on the conservation 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 or
21、ganization dealing with the global rules of trade between nations. Its main function is to ensure that trade flows as smoothly, predictably and freely as possible.,基因改造食品、WTO與CBD,11 September 2003 enter into force!,聯合國生物多樣性公約組織,70,GMOs,LMOs,GMF,LMOs GMOs GMF,*牛惠之(2002),LMOs v. GMOs v. GMF,71,LMO,GMO
22、,黃豆(生,熟),生黃豆(包括毛豆),黃豆(熟),豆腐,豆漿,黃豆粉,黃豆蛋白及其製品,GMF,LMOs v. GMOs v. GMF,* 高文彥(),72,http:/food.doh.gov.tw/life/biotech.htm,世界衛生組織,聯合國糧農組織,74,未來發展,召集專家諮商會議Call for Experts for Joint FAO/WHO Expert Consultation on Safety Assessment of Foods Derived from Genetically Modified Animals including FishRome, Italy, 17 - 21 November 2003,Source: http:/www.who.int/fsf/GMfood/fishexperts.htm,未來工作 一、 整合部會管理及立場(基本法?) 二、 建立科學風險評估能力 三、 資訊透明化 四、 加強推動生物技術產業 五、 促進國際合作,基因改造產品(GMO)之管理,75,92.07.17行政院衛生署 關心您,基因改造食品之安全性風險評估,基因轉殖家畜禽研發現況與生物安全評估研討會,
