基因改造食品之安全性风险评估课件.ppt

1、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”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

2、 Photo Unit,2001,USDA.簡介3(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(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好好吃的樣子我也想吃!(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)簡介7什麼是基因改造?Genetically Modified(GM)非傳統育種技術 現

3、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簡介1996199719981999200020012002S158.652.644.239.927.8111.70102030405060(百萬公頃)11

4、(百萬公頃)199619971998199920002001Soybean3.06.812.436.505101520253035SoybeanCornCottonCanolaGM作物-四大生產作物大豆玉米棉花油菜簡介12中國大陸4%美國67%阿根廷23%加拿大6%GM作物-四大生產國家簡介美國 35.7 39.0阿根廷 11.8 13.5加拿大 3.2 3.5中國大陸 1.5 2.1(百萬公頃)2001 200213耐農藥抗蟲抗蟲+耐農 藥抗病毒2002年耐農藥 40.6 44.2抗蟲 7.8 10.1 抗蟲+耐農藥 4.2 4.42001 2002百萬公頃 4hr2.熱穩定試驗熱穩定試驗

5、90C 19 min“There is no evidence to indicate that Cry9C is or is not a potential food allergen.”-US EPA,2000.SGF:Simulated Gastric Fluid(人造胃液)41Case StudyPepsin/testStability of protein in SGF(min)Protein ratio(w/w)10:1 1:11:10Food allergens b-lactoglobulin B120 120120 ovalbumin5 60120 papain0 00Nona

6、llergenic proteins Zein60 60120 Pea lectin5 120120 Cytochrome c0 0.50.5 Sucrose synthetase 0 00Source:Fu,et al.2002.過敏性評估:消化穩定性試驗之存疑Case Study42Allergenicity:Decision Tree Approach過敏性評估:43Allergenicity:Decision Tree ApproachSource of gene allergenicSequence HomologySpecific Serum ScreenTargeted Seru

7、m ScreenPepsin Resistance&Animal ModelsHigh +/+/-/-LowProbability of AllergenicityLikely allergenicSequence HomologyYesYesNoNoNoNoYesNo過敏性評估:44神秘神秘DNA事件事件(August 2001)Molecular Characterization of the genetic modificationCase StudyWindels P.et al.(2001)45-2001.4.2.-種植基因改造油菜花(GM Canola)孟山都生物科技種子訴訟糾紛

8、加拿大農夫敗訴！Monsanto vs.Percy SchmeiserHorizontal Gene Transfer(HGT)?(產品產品:加拿大芥花油加拿大芥花油)Case Study46*;Evaluation of GM canola in sheep and swine*u Agriculture and Agri-Food Canada Research Centres,LethbridgeuT.A.McAllister,R.Sharma,T.Alexander,K.Stanfordu LacombeM.Dugan,J.Aahlus,K.LienCase Study*Present

9、ed at The 6th APEC ATCWG meeting,Taipei,2002.Horizontal Gene Transfer(HGT)?4748Swine study-spleennDetection of transgene fragmentsF4F5F6P1 P2+P1 P2+P1 P2+F7F8F9F12P1 P2+P1 P2+P1 P2+P1 P2+F3P1 P2+49F4F5F6P1 +P1 +P1 +F7F8F9F12P1 P2 +P1 P2 +P1 P2 +P1 P2 +Swine study-spleennDetection of transgene fragme

10、nts50Swine study-kidneynDetection of transgene fragmentsF4F5F6P1 P2+P1 P2+P1 P2+F7F8F9F12P1 P2+P1 P2+P1 P2+P1 P2+51F4F5F6P1 +P1 +P1 +F7F8F9P1 +P1 +P1 +F12P1 +Swine study-kidneynDetection of transgene fragments52Conclusions-animal studynGM canola and its parental variety had the same feeding value fo

11、r both lambs and swine nSheep trialnTransgene not detectable in blood or tissuesnSwine trialnTransgene fragments detected in liver and kidney53Horizontal Gene Transfer(HGT)?ImplicationsnHGT(Horizontal Gene Transfer)nFrequency of such transfer54Horizontal Gene Transfer(HGT)?To improve resistance of p

12、iglet 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 factors VIII,IX and allergic proteins such as Derp(s).3.To generate transgenic pigs for xenotran

13、splantation.Purposes of Transgenic(Tg)Animals55Case StudyTg gilt No.8-3Tg gilt No.8-5Tg pigs harboring both transgenes of LA-pLF&LA-hFIX genes56Fig.Tissue-and stage-specific expression of aLA-FVIII transgene detected by RT-PCR57評估轉殖基因表達是否正常“Leaky Expression?”02/07/2003 Research Piglets Sold as Resea

14、rch Piglets Sold as Food Hard to Find,FDA Food Hard to Find,FDA Accused of Lax Biotech Accused of Lax Biotech RegulationRegulation WHO:美國伊利諾大學美國伊利諾大學(University of Illinois Urbana/Champaign)WHEN:4/2001 1/2003 WHAT:386頭頭 基因改造實驗乳豬基因改造實驗乳豬 販售給肉品商販售給肉品商58Case StudyI.食品安全Food SafetyIII.社會倫理ELSI(ethical,l

15、egal,social issues)IV.國際貿易TradeGM作物 四大議題59Case Study60 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MilkWeed)幼蟲半數死亡帝王蝶(黑脈金斑蝶)Monarch Butterfly61Case StudyCase StudyThe ProdiGene Incident62WHO-ProdiGene Inc.(College Station,TX)WHAT-edible vaccine grown in corn WHEN-11/13/2002 USDA investigationWHY-Contam

16、ination of 155 Acre soybeansRESULTS:$250,000 罰鍰罰鍰+$3,000,000 USDA補償款補償款+$1,000,000 保證金保證金1.美國加強聯邦法規美國加強聯邦法規: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)63I.食品安全Food SafetyII.環境生態Environmental SafetyIV.國際貿易TradeGM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What We Could V.What We Should65I

17、.食品安全Food SafetyII.環境生態Environmental SafetyIII.社會倫理ELSI(ethical,legal,social issues)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 sanctions under World

18、Trade Organisation(WTO)rules.基因改造食品與WTO67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)1.技術性貿易障礙協定 Technical Barrier to Trade(TBT)基因改造食品與WTO68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1.實施標示制度 有關GMOs之文件數 年度年度 TBT SPS 1995 1 4 1996 2 1 199711 0 199811 5 199920 2 20001420 20012537 2002 4

19、374 2003(1-6)1943 合計合計 146 186基因改造食品與WTO69Cartegena Protocol on Biosafety(生物安全議定書生物安全議定書)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 organisms(LMOs)resulting from

20、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 organization dealing with the

21、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CBD11 September 2003 enter into force!聯合國生物多樣性公約組織70 GMOs LMOsGMFLMOs GMOs GMF*牛惠之(2002)LMOs v.GMOs v.GMF71 LMOGMO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GM

22、FLMOs v.GMOs v.GMF*高文彥()72世界衛生組織聯合國糧農組織74未來發展未來發展召集專家諮商會議召集專家諮商會議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 2003Source: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7592.07.17行政院衛生署 關心您