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研究生: 戴呈軒
Tai, Chen-Hsuan
論文名稱: 論我國奈米科技醫藥發展應有之法律規範
Considering the Appropriate Laws and Regulations of Nanomedicine in Taiwan
指導教授: 范建得
Fan, Chien-Te
口試委員:
學位類別: 碩士
Master
系所名稱: 科技管理學院 - 科技法律研究所
Institute of Law for Science and Technology
論文出版年: 2010
畢業學年度: 98
語文別: 中文
論文頁數: 163
中文關鍵詞: 奈米醫藥奈米科技預防原則永續發展污染者付費原則
外文關鍵詞: Nanomedicine, Nanotechnology, Precautionary Principle, Environment Law, Risk Management
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  • 奈米科技係繼生物技術後另一將使人類生活大幅變革之新興技術。於奈米層級下,物質特性迥異而使其應用得以突破原有科技發展之瓶頸,尤其是於醫藥領域之發展,但奈米物質之特性亦引發對健康與環境之潛在風險,及對於現有社會、倫理與法律之衝擊,故透過法律規範建構一適宜且安全之環境,無疑係奈米醫藥發展之首要考量。

    過去歐美之政策皆認為既有規範足以因應奈米科技之發展,雖然目前尚未證實奈米物質與人體危害之直接相關性,而僅有實驗數據證實,諸多奈米物質會對細胞或生物體造成負面效應,但奈米醫藥或許如同基改產品與溫室氣體一般,其科技風險於短期內尚無法顯現,若一旦爆發將會對整體生態系、甚至整個人類生存空間、社會架構造成極大、而且深遠之影響。

    我國發展奈米科技亦有多年,發展重心卻仍聚焦於研發層面,尚未開啟奈米科技對於社會與法律之對話,2008年以降,歐美之管制政策開始出現變革性之轉變,本文以為其深具指標性之意義,進而認為有針對我國奈米醫藥管制規範研究之必要性。因奈米醫藥之風險仍不確定而有難以立法規範之爭議,本文檢視國際上最具代表性之歐美奈米醫藥管制制度,擬從其管制策略,並以永續發展之理念與意涵作為基礎,參考過去基改產品之管制經驗作為借鏡,歸納得出我國於奈米醫藥應有之法律規範,使得奈米醫藥因應之法規得以有效運作,並促進奈米醫藥之永續發展。


    第一章 緒論 1.1 研究動機、目的與重要性 1.2 研究範圍、架構與限制 1.2.1研究範圍 1.2.2研究架構 1.2.3研究限制 1.2.3.1 研究課題之限制 1.2.3.2 研究資料之不足與採取類推之研究方式 1.2.3.3 研究內容多屬論述而非科學實驗 1.2.3.4 跨領域之限制 1.3 研究方法 1.3.1 文獻分析法 1.3.2 歸納法 1.3.3 比較法 1.4 文獻回顧 1.4.1國內外奈米醫藥議題研究現況 1.4.2現行奈米醫藥發展研究之法律問題 第二章 奈米醫藥概述 2.1 奈米醫藥之名詞定義 2.2 奈米醫藥之應用與產業價值 2.2.1奈米生醫診斷與監測技術 2.2.2奈米生醫植體技術 2.2.3奈米生醫藥物技術 2.2.4奈米抗菌技術 2.3奈米科技在醫藥領域發展之潛在風險 2.3.1 奈米醫藥對健康安全之影響 2.3.2 奈米醫藥對環境生態之影響 2.3.3 奈米醫藥對社會倫理之影響 2.4 各國奈米醫藥應用發展現況 2.4.1 美國 2.4.2 歐盟 2.4.3 台灣 第三章 永續發展之理念與內涵 3.1 永續發展概念之興起 3.1.1 1972年以前之發展 3.1.2 1972年斯德哥爾摩人類與環境宣言 3.1.3 1987年《我們共同的未來》 3.1.4 2002年約翰尼斯堡行動計畫與永續發展宣言 3.2 永續發展的各種層面涵義與衍伸之基本原則探討 3.2.1 永續發展定義 3.2.2 奈米醫藥發展之科技永續意涵 3.2.3 奈米醫藥發展之經濟永續意涵 3.2.4 奈米醫藥發展之倫理永續意涵 3.2.5 小結 3.3 永續發展所衍伸之基本原則 3.3.1 合作概念 3.3.2 預防原則 3.3.3 污染者付費原則 3.4 奈米醫藥永續發展之問題與挑戰 3.4.1 奈米醫藥與永續發展之潛在衝突 3.4.2 自永續發展檢視奈米醫藥所面臨之問題 第四章 我國奈米醫藥相關法制現況 4.1 基礎研發階段 4.1.1 重要內容 4.1.2 運作現況與適用疑義 4.2 生產製程階段 4.2.1 勞工安全衛生法 4.2.2 毒性化學物質管理法 4.2.3 小結 4.3 產品上市及管理階段 4.3.1 奈米藥物 4.3.2 奈米醫療器材 4.3.3 其他管理規定 4.3.4 小結 4.4 輸出入階段 4.5 管理現況之問題 4.5.1 用語與定義不明 4.5.2 欠缺統一標準 4.5.3 規範落差 4.5.4 規範真空 第五章 比較法與奈米醫藥法規調適方向 5.1 美國奈米醫藥相關法制現況 5.1.1法規缺失檢討 5.1.1.1 毒性物質管制法 5.1.1.2 食品藥物及化妝品法 5.1.1.3 出口管制 5.1.2修正方向 5.2歐盟奈米醫藥相關法制現況 5.2.1 法規缺失檢討 5.2.1.1 歐盟生技醫學產品管制規範 5.2.1.2 歐盟醫療器材與藥物管制規範 5.2.1.3 歐盟化學物質管制規範:奈米粒子之分類 5.2.2 修正方向 5.3 從歐美奈米醫藥管理法制發展趨勢觀察 5.3.1階段式立法管制特定奈米物質 5.3.2負責任之奈米科技活動 5.3.3 以產品種類輔以風險分級為基礎之管理 5.3.4 奈米標示制度 第六章 我國奈米醫藥法制調適之具體建議 6.1我國奈米醫藥相關法制具體建議 6.1.1關於奈米醫藥之名詞統一定義 6.1.2關於奈米醫藥之上市前許可 6.1.3關於奈米醫藥之標示制度 6.1.4關於奈米醫藥之後續監控 6.1.5關於奈米醫藥之管制措施執行策略 6.1.6關於奈米醫藥之救濟機制 6.1.7關於奈米醫藥之公眾參與 6.2我國法規調適外仍面臨之倫理議題 結論 參考文獻

    參考文獻
    一、中文部份
    (一)專書
    戴正德,李明濱,「醫學倫理導論」,教育部,頁31,2006年1月增訂一版。
    盧美秀,「醫護倫理學」,五南圖書出版股份有限公司,頁11,2005年10月二版。
    柯澤東,「環境法論(二)」,自版,1995年。
    陳慈陽,「環境法總論」,元照出版有限公司,2003年修訂二版。
    世界環境與發展委員會著,王之佳、柯金良譯,「我們共同的未來」,台灣地球日出版社,1990年。
    財團法人國家實驗研究院科技政策研究與資訊中心,「各國奈米科技發展與規劃 Global Nanotechnology Development and Planning」, 2008年8月。
    葉俊榮,「全球環境議題-台灣觀點」,巨流出版社, 1999年。
    約翰.奈思比著:「高科技.高思維」,尹萍 譯,時報文化出版社,2000年5月,頁201。

    (二)期刊論文
    范建得、戴華,生物技術對倫理、法律與社會的影響及妥善的因應策略,國家政策季刊第3期,頁125-178,2004年9月。
    牛惠之,「科技法律」議題之研究,月旦法學雜誌,第116期,頁191-207,2005年1月。
    牛惠之、張孫福,「論基因改良食品之風險與社會議題—一點法律人之觀察與省思」,2001全國科技法律研討會論文集,頁599-621,2001年11月。
    李科逸,「英國促進環境科技研發相關措施之淺析」,科技法律透析,頁20-24,2006年12月。
    李昂杰、陳郁庭,「奈米科技對於健康之危害及法律對策-以我國既有法規之檢視與調適為中心」,科技法律透析,頁20-39,2005年12月。
    劉憶成,「奈米的趨避衝突—美國有毒奈米物質管制簡介」,技術尖兵,第125期,頁22-24,2005年5月。
    劉憶成,「奈米的遊戲規則,美國奈米法制簡介」,科技法律透析,頁2-7,2006年10月。
    黃書禮、許伶惠,永續發展之生態經濟觀,台灣經濟預測與政策,第24卷第1期,頁99-127,1993年。
    洪德欽,預防原則在WTO的規定與實踐,中央研究院報,第1880期,頁2-3,2008年7月。
    鄭師安,「奈米生醫之法制政策問題初探」,科技法律透析,頁7-13,2006年11月。
    陳羿谷整理,「2008我國負責任奈米科技之新契機座談會紀實」,科技法律透析,頁9-12,2008年8月。
    陳羿谷,美國地方政府奈米政策分析:以麻州劍橋市為例,科技法律透析,頁7-11,2008年11月。
    陳郁庭,美國環保署奈米材料管理計畫之簡介,科技法律透析,頁2-7,2008年1月。
    陳郁庭,探討美國關於奈米科技風險控管之規範芻議,科技法律透析第19卷第10期,頁7-12,2007年10月。
    陳郁庭,歐盟「負責任奈米科技研究活動」行為準則簡析,科技法律透析,頁2-8,2008年3月。
    阮國棟、吳婉怡、黃冠穎,「待解謎團——環境中奈米微粒」,科學發展421期,頁26-31,2008年1月。
    楊冠政,永續發展的倫理,環境教育季刊37期,頁82-86,1999年2月。
    楊婉苓,預防原則對GMO爭議之反省(下),科技法律透析,頁47-62,2003年1月。

    (三)法規資料
    廢棄物清理法,民國95年05月30日修正。
    廢棄物清理法施行細則,民國91年11月20日修正。
    毒性化學物質管理法,民國96年01月03日修正。
    毒性化學物質管理法施行細則,民國96年12月17日修正。
    勞工安全衛生法,民國91年06月12日修正。
    勞工安全衛生法施行細則,民國98年02月26日修正。
    醫療器材管理辦法,民國97年11月27日修正。
    藥事法,民國95年05月30日修正。
    藥事法施行細則,民國94年02月16日修正。

    (四)網路資料
    奈米標章網站:http://www.nanomark.itri.org.tw
    奈米國家型計畫網站:http://nano-taiwan.sinica.edu.tw,最後瀏覽日期2009年3月。
    奈米創新網:http://nano.stpi.org.tw/Nano_Future/future_news_contents.php?sid=100&l1=S_MENU_004&l2=CT001,最後瀏覽日期,2009年3月。
    牛惠之,管理基因改造產品之規範模式與制度設計,頁21,2005年11月,http://mx.nthu.edu.tw/~hcniu/paper/200504.pdf,最後瀏覽日期2009年10月。
    工研院奈米科技研發中心網頁:http://www.ntrc.itri.org.tw/research/bn07.jsp ,最後瀏覽日期2009年4月。
    資策會科技法律中心網頁http://stlc.iii.org.tw/ContentPage.aspx?i=2992,最後瀏覽日期2009年9月。
    吳悅,歐盟FP7之奈米科技研究與發展政策,科技政策智庫,http://thinktank.stpi.org.tw/eip/index/techdoc_content.jsp?doc_id=1186644640765&ver_id=6,最後瀏覽日期2007年8月。

    (五)學位論文
    李淑娟,「論奈米科技潛在風險之法律規範」,東海大學法律學系碩士論文,2005年。
    莊紘愷,自永續發展之理念論我國推行碳排放權交易所須建立之法律制度,清華大學科技法律研究所碩士論文,2008年。

    (六) 研究計畫
    牛惠之、張孫福、陳詩欣,「論預防原則之功能與運用-從環境保護法規到生物科技立法」,行政院國家科學委員會補助專題研究計畫成果報告,2001年10月。
    徐禮業,「奈米技術於環保領域之應用計畫」,行政院環保署編印,頁5-18,2004年2月。
    葉俊榮,「永續發展的決策機制法制興革,計畫子題一:邁向永續發展的決策機制」,國科會研究計畫成果,頁8-12,1999年。
    吳鴻鈞,「奈米微粒研磨作業爆炸預防研究」,行政院勞工委員會勞工安全衛生研究所,2007年3月。

    (七) 其他
    吳婉宜,陳怡萱,曹賜卿,阮國棟,行政院環保署科技發展組,國家型奈米計畫環境議題第二期六年研發規劃,96年環境科技奈米論壇論文集,頁1-13,2008年1月11日。

    二、外文部份
    (一)專書
    B. KASEMIR, C. C. JAEGER, J. JÄGER, CITIZENSHIP PARTICIPATION IN SUSTAINABILITY ASSESSMENTS, IN B. KASEMIR ET AL. (ed), PUBLIC PARTICIPATION IN SUSTAINABILITY SCIENCE: A HANDBOOK (CAMBRIDGE UNIVERSITY PRESS: CAMBRIDGE, 2003).
    CARING FOR THE EARTH, A STRATEGY FOR SUSTAINABLE LIVING (1991).
    D FREESTONE & E HEY, ORIGINS AND DEVELOPMENT OF THE PRECAUTIONARY PRINCIPLE, IN D FREESTONE & E
    HEY (eds), INTERNATIONAL LAW AND GLOBAL CLIMATE CHANGE, GRAHAM & TROTMAN/MARTINUS NIJHOFF(1991)
    J. D. FEARON, DELIBERATION AS DISSUSSION, IN J. ELSTER (ed.), DELIBERATIVE DEMOCRACY (CAMBRIDGE UNIVERSITY PRESS: CAMBRIDGE, 1998).
    LEONARD ORTOLANO, ENVIRONMNETAL REGULATION AND IMPACT ASSESSMENT (1997).
    LOUIS THEODORE , NANOTECHNOLOGY, BASIC CALCULATIONS FOR ENGINEERS AND SCIENTIST (2006).
    MARIE-CLAIRE CORDONIER SEGGER & ASFAQ KHALFAN, SUSTAINABLE DEVELOPMENT LAW:PRINCIPLES, PRACTICES, & PROSPECTS (2006).
    MARK GEISTFELD, IMPLEMENTING THE PRECAUTIONARY PRINCIPLE, 31 (2001).
    NANOTECHNOLOGY RESEARCH DIRECTION: VISION FOR NANOTECHNOLOGY IN THE NEXT DECADE (2007).
    NANOTECHNOLOGY, BASIC CALCULATIONS FOR ENGINEERS AND SCIENTIST 95-116 (2006).
    PHILIPPE SAND, PRINCIPLES OF INTERNATIONAL ENVIRONMENT LAW (2d Ed.2003).
    STUART BELL & DONALD MCGILLVRAY, ENVIRONMENTAL LAW (6d Ed. 2006)
    TOM L. BEAUCHAMP, JAMES F. CHILDRESS, PRINCIPLES OF BIOMEDICAL ETHICS 57-282 (5TH ED. 2001).
    UNITED NATIONS EDUCATIONAL, SCIENTIFIC AND CULTURAL ORGANIZATION (UNESCO), THE ETHICS AND POLITICS OF NANOTECHNOLOGY (2006).
    UNITED NATIONS EDUCATIONAL, SCIENTIFIC AND CULTURAL ORGANIZATION (UNESCO), HENK A. M .J. TEN HAVE (ED.), NANOTECHNOLOGIES, ETHICS AND POLITICS (2007).
    UNITED NATIONS EDUCATIONAL, SCIENTIFIC AND CULTURAL ORGANIZATION (UNESCO), THE PRECAUTIONARY PRINCIPLE (2005).
    WORLD COMMISSION ON ENVIRONMENT AND DEVELOPMENT, OUR COMMON FUTURE (1987).

    (二)期刊論文
    A Mnyusiwalla, AS Daar, PA Singer, ‘Mind the gap’: science and ethics in nanotechnology. 14 Nanotechnology 9-13 (2003).
    A. El-Ansary, S. Al-Daihan, On the Toxicity of Therapeutically Used Nanoparticles:An Overview, 2009 Journal of Toxicology. 1-9(2009).
    AD Maynard, RJ Aitken, T Butz, V Colvin, Safe handling of nanotechnology. 444(16) Nature. 267–269(2006).
    AR Shahverdi, A Fakhimi, HR Shahverdi, S Minaian, Synthesis and effect of silver nanoparticles on the antibacterial activity of different antibiotics against Staphylococcus aureus and Escherichia coli. Nanomed. Nanotechnol. 3 Biol. Med. 168–171(2007).
    Barthlott, W. and Neinhuis, C., Purity of the sacred lotus, or escape from contamination in biological surfaces, 202 Planta. 1-8 (1997).
    Bernadette Bensaude-Vincent, Self-Assembly, Self-Organization: Nanotechnology and Vitalism, 3 Nanoethics 31-42(2009).
    C Loo, A Lowery, N Halas, J West, R Drezek, Immunotargeted nanoshells for integrated cancer imaging and therapy, 5(4) Nano letters. 709-711 (2005).
    Chris Toumey, Privacy in the Shadow of Nanotechnology, 1 NanoEthics. 211-222 (2007).
    David Hodas, The Climate Change Convention and Evolving Legae Model Of Sustainable Development, 13 Pace Envtl. L. Rec. 75-96 (1995).
    E Navarro, F Piccapietra, B Wagner, F Marconi, Toxicity of Silver Nanoparticles to Chlamydomonas reinhardtii, 42(23) Environmental Science & Technology.8959-8964(2008).
    E Navarro, F Piccapietra, B Wagner, F Marconi, Toxicity of Silver Nanoparticles to Chlamydomonas reinhardtii, 42(23) Environmental Science & Technology.8959-8964 (2008).
    F Chen, D Gerion, Fluorescent CdSe/ZnS Nanocrystal−Peptide Conjugates for Long-term, Nontoxic Imaging and Nuclear Targeting in Living Cells, 4 (10) Nano Letters. 1827-1850 (2004).
    Feynman RP, There’s plenty of room at the bottom, 23 Eng Sci (Caltech). 22-57 (1960).
    G Guerra, European Regulatory Issues in Nanomedicine, 2 Nanoethics. 87-97 (2008).
    G. Oberd¨orster, E. Oberd¨orster, and J. Oberd¨orster, Nanotoxicology: an emerging discipline evolving from studies of ultrafine particles, 113(7) Environmental Health Perspectives. 823–839(2005).
    G. Oberd¨orster, V. Stone, and K. Donaldson, Toxicology of nanoparticles: a historical perspective, 1(1) Nanotoxicology. 2–25(2007).
    HY Lee, HK Park, YM Lee, K Kim, SB Park, A practical procedure for producing silver nanocoated fabric and its antibacterial evaluation for biomedical applications. 2007 Chem. Commun. 2959–2961 (2007).
    J Miller, Beyond biotechnology: FDA regulation of nanomedicine, 5 The Columbia Science and Technology Law Review. 1-35 (2003).
    J Schummer, E Pariotti, Regulating Nanotechnologies: Risk Management Models and Nanomedicine, 2 Nanoethics. 39-42 (2008).
    J. P. Rayman-Rasmussen, J. E. Riviere, and N. A. Monteiro-Riviere, Variables infleuncing interactions of uncharged quantum dot nanoparticles with skin cells and identification of biochemical modulators, 7(5) Nano Letters. 1344–1348 (2007).
    JD Fortner, DY Lyon, CM Sayes, AM Boyd, JC Falkner, C60 in water: nanocrystal formation and microbial response, Environ. 39 (11) Sci. Technol. 4307–4316 (2005).
    JS Kim, E Kuk, KN Yu, JH Kim, SJ Park, HJ Lee, Antimicrobial effects of silver nanoparticles. Nanomed. Nanotechnol. 3 Biol. Med. 95–101(2007).
    KO Yu, CM Grabinski, AM Schrand, Toxicity of amorphous silica nanoparticles in mouse keratinocytes, 11 J Nanopart Res. 15-24 (2009).
    Kristin Shrader-Frechette, Nanotoxicology and Ethical Conditions for Informed Consent, 1 Nanoethics. 47-56 (2007).
    L Zhang, JM Chan, FX Gu, JW Rhee, AZ Wang, Self-Assembled Lipid-Polymer Hybrid Nanoparticles: A Robust Drug Delivery Platform, 2(8) ACS nano. 1696–1702 (2008).
    LJ Mortensen, G Oberdörster, AP Pentland, In vivo skin penetration of quantum dot nanoparticles in the murine model: the effect of UVR, 8(9) Nano Letters. 2779-2787(2008).
    M. Ebbesen, The Role of the Humanities and Social Sciences in Nanotechnology Research and Development, 2(1) NanoEthics. 1-13(2008).
    Mekel, Michele, Small science, big potential and bigger issues, 49 Development, 47-53 (2006).
    Oberdorster G, Sharp Z, Atudorei V, Elder A, Gelein R, Lunts A, Kreyling W, Cox C, Extrapulmonary translocation of ultra carbon particle following whole-body inhalation exposure of rats, J. 65 Toxicol. Environ.Health A, 1531-1543(2002).
    P Lin, JW Chen, LW Chang, JP Wu, L Redding, Computational and Ultrastructural Toxicology of a Nanoparticle, Quantum Dot 705, in Mice, 42(16)Environmental Science & Technology. 6264–6270(2008).
    P. Borm, F. C. Klaessig, T. D. Landry, et al., Research strategies for safety evaluation of nanomaterials, part V: role of dissolution in biological fate and effects of nanoscale particles, 90(1) Toxicological Sciences. 23–32 (2006).
    Philip C. Nasca, Current Problems That Are Likely to Affect the Future of Epidemiology. 146(11) American Journal of Epidemiology 907-911(1997).
    R Kemp, S Parto, RB Gibson, Governance for sustainable development: moving from theory to practice, 8(1/2) Int. J. Sustainable Development 12,16 (2005).
    R Langer, New methods of drug delivery, 249(4976) Science. 1527-1533 (1990).
    RA Freitas, What is nanomedicine? 51(6 )Disease-a-Month 325-341 (2005).
    Roger Brownsword, Regulating Nanomedicine—The Smallest of Our Concerns? 2 NanoEthics. 73–86 (2008).
    RSH Yang, LW Chang, JP Wu, MH Tsai, HJ Wang, Persistent Tissue Kinetics and Redistribution of Nanoparticles,QuantumDot 705, in Mice:ICP-MS Quantitative Assessment. Environ. 115 (9)Health Perspect. 1339–1343(2007).
    S Lubbe, C Alexiou, C Bergemann, Clinical Application of Magnetic Drug Targeting, 95 Journal of Surgical Research. 200-206(2001).
    S. M. Hussain, A. K. Javorina, A. M. Schrand, H. M. Duhart, S. F. Ali, and J. J. Schlager, The interaction of manganese nanoparticles with PC-12 cells induces dopamine depletion, 92(2) Toxicological Sciences. 456–463(2006).
    S. M. Hussain, K. L. Hess, J. M. Gearhart, K. T. Geiss, and J. J. Schlager, In vitro toxicity of nanoparticles in BRL 3A rat liver cells, 19(7) Toxicology in Vitro. 975–983(2005).
    S. M. Hussain, K. L. Hess, J. M. Gearhart, K. T. Geiss, and J. J. Schlager, In vitro toxicity of nanoparticles in BRL 3A rat liver cells, 19(7) Toxicology in Vitro. 975–983 (2005).
    S. Takenaka, E. Karg, C. Roth, et al., Pulmonary and systemic distribution of inhaled ultrafine silver particles in rats, 109(4) Environmental Health Perspectives. 547–551(2001).
    S. Zhang, Z. Bian, C. Gu, et al., Preparation of anti-human cardiac troponin I immunomagnetic nanoparticles and biological activity assays, 55(2) Colloids and Surfaces B: Biointerfaces. 143–148 (2007).
    SA Blaser, M Scheringer, M MacLeod, K Hungerbühler, Estimation of cumulative aquatic exposure and risk due to silver: Contribution of nano-functionalized plastics and textiles, 390 Science of the Total Environment. 396-409 (2008).
    Sang H. Choi, Nano-Bio Quantum Technology for Device-Specific Materials. 7291 Proc. of SPIE, 72910L-1-72910L-6 (2009).
    T Zhang, JL Stilwell, D Gerion, L Ding, Cellular Effect of High Doses of Silica-Coated Quantum Dot Profiled with High Throughput Gene Expression Analysis and High Content Cellomics Measurements, 6(4) Nano letters. 800-808 (2006).
    Tamara Garcia, Ronald Sandler, Enhancing Justice? 2 Nanoethics. 277–287 (2008).
    W Lin, Y Xu, CC Huang, Y Ma, KB Shannon, Toxicity of nano-and micro-sized ZnO particles in human lung epithelial cells, 11 J Nanopart Res. 25-39 (2009).
    X Zhu, L Zhu, Y Chen, S Tian, Acute toxicities of six manufactured nanomaterial suspensions to daphnia magna, 11 J Nanopart Res. 67-75 (2009).
    YT Lim, S Kim, A Nakayama, NE Stott, MG Bawendi, Selection of quantum dot wavelengths for biomedical assays and imaging., 2 (1) official journal of the Society for Molecular Imaging. 50–64(2003).

    (三)網路資料
    Adriano Cavalcanti, Robots in Surgery, Plenary Lecture, Euro Nano Forum 2005, Nanotechnology and the Health of the EU Citizen in 2020. 1,3 (2005). http://www.nanorobotdesign.com/papers/robotsInSurgery.pdf (last visited June, 2009).
    Cavalcanti, B Shirinzadeh, D Murphy, J Smith, Nanorobots for Laparoscopic Cancer Surgery, IEEE ICIS (2007). http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.94.8129&rep=rep1&type=pdf (last visited June, 2009).

    Class I / II Exemptions, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051549.htm (last visited October 20, 2009).
    Commission of the European Communities, Communication from the commission on the precautionary principle, Brussels, 02.02.2000,1 COM(2000). http://ec.europa.eu/dgs/health_consumer/library/pub/pub07_en.pdf(last visited August, 2009).
    Device Labeling, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/default.htm (last visited October 20, 2009).
    Device Registration and Listing, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm (last visited October 20, 2009).
    Environmental Protection Agency, Nanoscale Materials Stewardship Program (2009), http://www.epa.gov/oppt/nano/nmsp-interim-report-final.pdf (last visited September 29, 2009).
    EPA之Nanoscale Materials Stewardship Program, http://www.epa.gov/oppt/nano/stewardship.htm(last visited July, 2009).
    Euractiv Network, Germany opposed nano label for cosmetics, available at http://www.euractiv.com/en/enterprise-jobs/germany-opposed-nano-label-cosmetics/article-187583 (last visited December 30, 2009).
    European Commission, Commission Recommendation On A Code Of Conduct For Responsible Nanosciences And Nanotechnologies Research (2008). ftp://ftp.cordis.europa.eu/pub/fp7/docs/nanocode-recommendation.pdf (last visited September 29, 2009).
    European Commission, European activities in the field of ethical, legal and social aspects (ELSA) and governance of nanotechnology (2008), ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/elsa_governance_nano.pdf (last visited September 26, 2009).
    European Commission, The Third European Report on Science & Technology Indicators: Towards a European Strategy for Nanotechnology http://ec.europa.eu/research/industrial_technologies/pdf/nanotechnology_communication_en.pdf(last visited September 26, 2009).
    European Commission, The Third European Report on Science & Technology Indicators: An Action Plan 2005–2009 http://www.cordis.lu/nanotechnology/(last visited September 26, 2009).
    European Commission, The Third European Report on Science & Technology Indicators: Towards a European Strategy for Nanotechnology(2004) http://ec.europa.eu/research/industrial_technologies/pdf/nanotechnology_communication_en.pdf (last visited September 26, 2009).
    European Parliament, REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on cosmetic products (recast), available at http://register.consilium.europa.eu/pdf/en/09/st03/st03623.en09.pdf (last visited December 30, 2009).
    Fair Packaging and Labeling Act of FDA http://www.fda.gov/RegulatoryInformation/Legislation/ucm148722.htm (last visited October, 2009)
    FAO, WHO, Risk Management and Food Safety (1997). ftp://ftp.fao.org/docrep/fao/w4982e/w4982e00.pdf (last visited September 30, 2009).
    FDA網站Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm (last visited October, 2009)
    Nanotechnology, Science & Research of FDA, http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm (last visited October, 2009)
    Food and Drug Administration , A Report of the U.S. Food and Drug Administration Nanotechnology Task Force (2007), http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/Nanotechnology/ucm110856.pdf (last visited September 20, 2009).
    Food and Drug Administration, Code of Federal Regulations, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm (last visited September 20, 2009).
    Food and Drug Administration, Fair Packaging and Labeling Act, http://www.fda.gov/RegulatoryInformation/Legislation/ucm148722.htm (last visited September 20, 2009).
    Food and Drug Administration, Food, Drug and Cosmetic Act, http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm (last visited September 20, 2009).
    Food and Drug Administration, Public Health Service Act, http://www.fda.gov/RegulatoryInformation/Legislation/ucm148717.htm (last visited September 20, 2009).
    FP7, Nanosciences, nanotechnologies, materials & new production technologies (NMP), http://cordis.europa.eu/fp7/cooperation/nanotechnology_en.html (last visited September 5, 2009).
    Freitas R A Jr 1999 Nanomedicine vol I Basic Capabilities Landes Bioscience http://www.nanomedicine.com (last visited August 23, 2009).
    Georgia Miller, "Workplace exposure to nanomaterials : Will nano be the next asbestos?", Friends of Earth, 3(2006). http://nano.foe.org.au/filestore2/download/116/Workplace%20exposure%20to%20nano%20-%20Background%20Paper%20May%202006.pdf (last visited August 23, 2009).
    http://www.nano.gov/html/about/funding.html (last visited April 1, 2009).
    Insight investment, Royal Society, Center for Process Innovation, Nanotechnology Industries Association, information on the Responsible Nano Code, May 2008, http://www.responsiblenanocode.org/documents/TheResponsibleNanoCodeUpdateAnnoucement.pdf
    ISO/TC 229 Business Plan, Nanotechnologies (2007), http://isotc.iso.org/livelink/livelink/fetch/2000/2122/4191900/4192161/TC_229_BP_2007-2008.pdf?nodeid=6356960&vernum=0 (last visited August 23, 2009).
    J. Clarence Davies, Managing The Effect of Nanotechnology, Woodrow Wilson International Center for Scholars (2006). http://www.wilsoncenter.org/events/docs/Effectsnanotechfinal.pdf (last visited September 12, 2009).
    Nanosciences and Nanotechnologies︰An Action Plan For Europe 2005-2009, june 2005, at 11. http://ec.europa.eu/research/industrial_technologies/pdf/nano_action_plan_en.pdf ,(last visited July, 2009).
    Nanotechnology Law Report, EPA Issues Significant New Use Rules for Two Nanomaterials (2008), http://www.nanolawreport.com/2008/11/articles/epa-issues-significant-new-use-rules-for-two-nanomaterials/ (last visited September 28, 2009).
    Nanotechnology Law Report網站:http://www.nanolawreport.com/2008/11/articles/epa-issues-significant-new-use-rules-for-two-nanomaterials/ (last visited September 28, 2009).
    Nanotechnology Safety Act of 2010 (Introduced in Senate), available at http://thomas.loc.gov/cgi-bin/query/z?c111:S.2942: (last visited Mar 26, 2010).
    Nanotechnology Task Force Report 2007 http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/Nanotechnology/ucm110856.pdf (last visited August 23, 2009).
    National Nanotechnology Initiative (NNI), http://www.nano.gov/html/facts/whatIsNano.html (last visited August 23, 2009).
    National Nanotechnology Initiative , Research and Development Leading to a Revolution in Technology and Industry 14, http://www.nano.gov/NNI_06Budget.pdf (last visited September 7, 2009).
    National Nanotechnology Initiative, Research and Development Leading to a Revolution in Technology and Industry-Supplement to the President's FY 2007 Budget , 35 (2006), http://www.nano.gov/NNI_07Budget.pdf (last visited September 7, 2009).
    Planning and Development Department, Toxics Management Division, City of Berkeley, “Manufactured Nanoscale Materials Health and Safety Disclosure”, available at http://www.ci.berkeley.ca.us/uploadedFiles/Planning_(new_site_map_walk-through)/Level_3_-_General/Manuffactured%20Nanoscale%20Materials.pdf (last visited September 30, 2009).
    PMA Approvals, http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/pmaapprovals/default.htm (last visited October 20, 2009).
    Public Health Service Act of FDA http://www.fda.gov/RegulatoryInformation/Legislation/ucm148717.htm,(last visited October 20, 2009).
    Quality System Regulation Labeling Requirements, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/QualitySystemRegulationLabelingRequirements/default.htm (last visited October 20, 2009).
    U.S. Environmental Protection Agency, Nanotechnology White Paper (2007). http://www.epa.gov/osa/pdfs/nanotech/epa-nanotechnology-whitepaper-0207.pdf (last visited August 23, 2009).

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