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    Title: 論基因編輯食品管理之國際貿易障礙問題與可能解決方法
    A Study on International Trade Barriers and Potential Solutions Regarding the Regulation of Genome-Edited Foods
    Authors: 蘇意晴
    Su, Yi-Ching
    Contributors: 楊培侃
    Yang, Pei-Kan
    蘇意晴
    Su, Yi-Ching
    Keywords: 基因編輯
    基因編輯食品管理
    基因編輯食品國際貿易障礙
    Genome edit
    Management of genome-edited foods
    International trade barriers of genome-edited foods
    Date: 2023
    Issue Date: 2023-08-02 13:14:22 (UTC+8)
    Abstract: 基因編輯技術近年來發展蓬勃，使用此技術製造之食品數量成長迅速，然而其因對人類、動植物以及環境安全性產生之風險而需受管制。目前各國對基因編輯食品之管理方式有所不同，主要可分為四類：以基因改造食品待之、逐案分類、早期諮詢流程以及未將基因編輯食品納管。其中導致主要基因編輯食品貿易障礙之管理方式為「以基因改造食品待之」以及「未將基因編輯食品納管」，本文接下來之分析與討論便以前開兩種管理方式為主要對象。
    本文首先討論多邊貿易架構——世界貿易組織之貿易規範對基因編輯食品管理措施之適用性，列舉出可能適用之條文以及因編輯食品國際標準之研議與發展現況。接著本文探討當前基因編輯食品管理主要貿易障礙與世界貿易組織貿易規範之合致性，發現目前世界貿易組織可能鑑於基因編輯食品有關國際標準之缺乏以及科學證據之不充足，難以認定前開兩種管理措施違反其條文義務。而本文提出三條世界貿易組織處理基因編輯食品貿易障礙之可能途徑，分別為儘速建立國際標準、透過SPS委員會討論，以及透過現行爭端解決解釋處理。
    接下來本文探討區域貿易協定對基因編輯食品貿易之規範與影響，以《美國—墨西哥—加拿大協定》為例，討論其第三章農業協定與第九章食品安全檢驗與動植物防疫檢疫措施協定對前開造成基因編輯食品主要貿易障礙之管理方式之影響，發現彼等可部分解決貿易障礙之問題，然亦有侷限性。最後，本文比較多邊貿易架構及區域貿易協定於處理基因編輯食品管理之國際貿易障礙問題之優點與限制，發現區域貿易協定較多邊貿易架構擁有較佳之意見反應機制，而多邊貿易架構擁有較大之影響力。
    The genome edit technology has been flourishing in recent years, leading to a rapid increase in the production of genome-edited foods. However, due to the risks they pose to human health, animals, plants, and the environment, the regulation of these foods is necessary. Currently, different countries have different approaches to the management of genome-edited foods, which can be mainly categorized into four types: treating them as genetically modified foods, categorical case-by-case, early consultation procedures, and non-regulation of genome-edited foods. Among these approaches, the ones that mainly cause trade barriers for genome-edited foods are “treating them as genetically modified foods” and “non-regulation of genome-edited foods”. The analysis and discussion in this article focus on these two main management approaches.
    Firstly, this article discusses the applicability of the trade regulations of the multilateral trading framework, particularly the World Trade Organization, to the management measures of genome-edited foods. It lists the relevant provisions that may apply and examine the current status of international standards for genome-edited foods. The article then explores the legality between the two above-mentioned management approach that cause trade barriers for genome-edited foods and the trade regulations of the World Trade Organization. It finds that the World Trade Organization has difficulty determining a violation of its provisions regarding genome-edited foods due to the lack of internationally recognized standards and the insufficiency of scientific evidence. The article proposes three possible approaches for the World Trade Organization to address trade barriers for genome-edited foods: establishing international standards as soon as possible, discussing the issue through the SPS Committee, and handling the issue through the interpretation of existing dispute resolution mechanisms.
    Next, the article examines the regulations and impact of regional trade agreements on the trade of genome-edited foods, taking the “United States-Mexico-Canada Agreement” as an example. It discusses the influence of Chapter 3 and Chapter 9 of this agreement on the management approaches for the major trade barriers related to genome-edited foods. It finds that the agreement can partially resolve trade barriers but also has limitations. Finally, the article compares the advantages and limitations of the multilateral trading framework and regional trade agreements in addressing international trade barriers related to genome-edited foods management. It concludes that regional trade agreements have a better mechanism for exchanging information and opinions, while the multilateral trading framework has greater influence.
    Reference: 一、中文文獻
    （一）期刊
    李素華，由聯合國及歐盟基因改造食品管理標示規範趨勢研析我國基因改造食品相關法制，科技法律透析，13卷9期、10期，頁49-62、24-35（2001年）。
    林彩瑜，從歐體生技產品爭端之裁決 論SPS協定對GMO規範之影響，臺大法學論叢，36卷4期，頁257-323（2007年）。
    楊培侃，從私營標準之發展論SPS協定在全球食品安全治理之功能與限制，科技法學評論，11卷1期，頁29-74（2014年）。
    賴珮萱，「試析『韓國─輻射案』─以SPS協定第5.6及2.3條為中心」，政治大學國際經貿組織暨法律研究中心經貿法訊，231期，頁35-36。
    譚偉恩、許耀明，論WTO《SPS協定》與Codex瘦肉精安全標準之適當性，科技法學評論，12卷1期，頁1-55（2015年）。
    （二）法規
    食品安全衛生管理法第3條第11款。
    食品衛生管理法第11條第1項第9款。
    食品安全衛生管理法第21條。
    二、外文文獻
    （一）期刊論文
    David W. Bullock ET AL., Gene Editing Versus Genetic Modification in the Research and Development of New Crop Traits: An Economic Comparison, 103(5) AM. J. AGRIC. ECON.1700 (2021).
    Erin Zess & Matthew Begemann, CRISPR-Cas9 and Beyond: What’s Next in Plant Genome Engineering, 57 IN VITRO CELLULAR & DEVELOPMENTAL BIOLOGY – PLANT 584 (2021).
    Fred Gould et al., Toward Product-Based Regulation of Crops, 377(6610) SCIENCE 1051, 1051 (2022).
    Hamilton O. Smith et al., A Restriction Enzyme from Hemophilus Influenzae: II. Base Sequence of the Recognition Site, 51(2) J. MOLECULAR BIOLOGY 393, 393 (1970).
    Hanspeter Naegeli et al., Applicability of the EFSA Opinion on Site-Directed Nucleases type 3 for the Safety Assessment of Plants Developed Usingsite-Directed Nucleases Type 1 and 2 and Oligonucleotide-Directed Mutagenesis, EFSA J. 1, 7 (2020).
    Holger Puchta, Updates on gene editing and its applications, 188(4) PLANT PHYSIOLOGY 1725, 1726 (2022).
    Jeffrey D. Wolt et al., The Regulatory Status of Genome-edited Crops, 14 PLANTBIOTECH. J. 510, 510 (2016).
    Jochen Menz et al., Genome Edited Crops Touch the Market: A View on the Global Development and Regulatory Environment, 11 FRONTIERS IN PLANT SCIENCE 1 (2020).
    Jonathan R. Latham, The Mutational Consequences of Plant Transformation, 2006 BIOMED RESEARCH INT’L 1, 5 (2006).
    Kenneth W. Ellens et al., Canadian Regulatory Aspects of Gene Editing Technologies, 28 TRANSGENIC RES. 165 (2019).
    Kevin V. Pixley et al., Genome-Edited Crops for Improved Food Security of Smallholder Farmers, 54 NATURE GENETICS 364, 364 (2022).
    Martin Jinek et al., A Programmable Dual-RNA–Guided DNA Endonuclease in Adaptive Bacterial Immunity, 337(6096) SCIENCE 816 (2012).
    Mazhar Adli, The CRISPR Tool Kit for Genome Editing and Beyond, 9 NATURE COMMUNICATIONS 1,2 (2018).
    Michael Pacher & Holger Puchta, From Classical Mutagenesis to Nuclease-Based Breeding – Directing Natural DNA Repair for a Natural End-Product, 90 THE PLANT J. 819, 830 (2017).
    Noel Sauer et al., Oligonucleotide-Directed Mutagenesis for Precision Gene Editing, 14(2) PLANT BIOTECHNOLOGY J. 496, 498 (2016).
    Pei-Kan Yang, Regulatory Options for Importation of Genome-Edited Foods in Taiwan, 17 NAT’L TAIWAN UNIV. L. REV. 73, 79 (2022).
    R J Rothstein, One-Step Gene Disruption in Yeast, 101 METHODS ENZYMOLogy 202 (1983).
    Stella G. Uzogara, The Impact of Genetic Modification of Human Foods in the 21st Century: A Review, 18 BIOTECHNOLOGY ADVANCE 179, 182 (2000).
    Thomas, K. R. et al. High Frequency Targeting of Genes to Specific Sites in the Mammalian Genome, 44(3) Cell 419 (1986).
    Tomasz Zimny & Stawomir Sowa, Potential Effects of Asymmetric Legal Classification of Gene Edited Plant Products in International Trade, from the Perspective of the EU, 1 EFB BIOECONOMY J. 1,1(2021).
    （二）WTO協定、案例與相關文件
    Agreement on Technical Barriers to Trade, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex1A, 1868 U.N.T.S. 120.
    Agreement on the Application of Sanitary and Phytosanitary Measures, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex1A, 1867 U.N.T.S. 493.
    Appellate Body Report, Japan — Measures Affecting Agricultural Products, WTO Doc. WT/DS76/AB/R (adopted Mar. 19, 1999).
    Panel Report, European Communities — Measures Concerning Meat and Meat Products (Hormones), WTO Doc. WT/DS26/R/USA (adopted Feb. 13,1998).
    Panel Report, Japan – Measures Affecting the Importation of Apples, WTO Doc. WT/DS245/R (adopted Dec. 10, 2003).
    （三）外國法規、條約與案例
    APHIS, Final Rule, Movement of Certain Genetically Engineered Organisms, 7 C.F.R. Parts 330, 340, and 372 (U.S.D.A. Aug. 17, 2020).
    Case C‑528/16, Confédération paysanne and Others v Premier ministre, Ministre de l’Agriculture, de l’Agroalimentaire et de la Forêt, 2018 E.C.R. 54 [hereinafter Case C-528/16].
    Commission Regulation 1829/2003, of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed.
    Commission Regulation 1830/2003, of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC, 2003 O.J. (L 268), 24-28.
    Commission Regulation 1946/2003, of the European Parliament and of the Council on transboundary movements of genetically modified organisms, 2003 O.J. (L 287), 1-10.
    Council Directive 2002/53/EC, of 13 June 2002 on the common catalogue of varieties of agricultural plant species, 2002 O.J. (L 193), 1-11.
    Council Directive 90/220/EEC, of 23 April 1990 on the deliberate release into the environment of genetically modified organisms, 1990 O.J. (L 117), 15-27.
    Directive 2001/18/EC, of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, 2001 0.J. (L 106,) 1, 1-39.
    Directive 2009/41/EC, of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance), 2009 O.J. (L 125), 75-97.
    Directive 2015/412, of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory Text with EEA relevance, 2015 O.J. (L 68), 1-8 (EU).
    Exec. Order No 13,874, 84 F.R. 115, Modernizing the Regulatory Framework for Agricultural Biotechnology Products (June 11, 2019), https://www.govinfo.gov/content/pkg/FR-2019-06-14/pdf/2019-12802.pdf.
    Feeds Act, R.S.C. 1985, c. F-9; Food and Drugs Act, R.S.C. 1985, c. F-27; Seeds Act, R.S.C. 1985, c. S-8.
    Gene Technology Act 2000, No. 169, 2000 (Austl.), https://www.legislation.gov.au/Details/C2016C00792.
    Gene Technology Regulations 2001 (Austl.), https://www.legislation.gov.au/Details/F2016C00615.
    Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants, CAC/GL 68-2008, https://www.who.int/docs/default-source/food-safety/food-genetically-modified/cxg-068e.pdf?sfvrsn=c9de948e_2.
    Ministerio de Agricultura, Ganaderia y Pesca [Ministry of Agriculture, Livestock and Fisheries], Resoluci6n 173/2015 [Resolution 173/2015], Bs. As., 12/5/2015, https://www.argentina.gob.ar/normativa/nacional/resoluci%C3%B3n-173-2015-246978/texto.
    OFFICE. OF SCI. & TECH. POL`Y (O.S.T.P.), Coordinated Framework for the Regulation of Biotechnology (1986).
    Protocol Replacing the North America Free Trade Agreement with the Agreement Between the United States of America, the United Mexican States, and Canada, Nov. 30, 2018, https://ustr.gov/trade-agreements/free-trade-agreements/united-states-mexico-canada-agreement/agreement-between [hereinafter USMCA]; United States-Mexico-Canada Agreement, OFF. OF THE U.S. TRADE REP. [USTR], https://ustr.gov/trade-agreements/free-trade-agreements/united-states-mexico-canada-agreement (last visited May 1, 2023).
    United Nations, Report of the World Food Conference, Rome 5-16 November, 1974 (New York: United Nations, 1975).
    （四）機構文件
    FRANK BIERMANN & PHILIPP H. PATTBERG, GLOBAL ENVIRONMENT GOVERNANCE RECONSIDERED 77 (2012).
    FSANZ, Final Report, Review of Food Derived Using New Breeding Techniques 5 (2019), https://www.foodstandards.gov.au/consumer/gmfood/Documents/NBT%20Fina%20report.pdf.
    O.S.T.P., Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (Jan. 4, 2017), at 55, https://www.fda.gov/media/102658/download.
    OFFICE. OF SCI. & TECH. POL`Y (O.S.T.P.), Coordinated Framework for the Regulation of Biotechnology (1986).
    PHILLIPS MCDOUGALL, THE COST AND TIME INVOLVED IN THE DISCOVERY, DEVELOPMENT AND AUTHORISATION OF A NEW PLANT BIOTECHNOLOGY DERIVED TRAIT 10 (2011), https://croplife.org/wp-content/uploads/2014/04/Getting-a-Biotech-Crop-to-Market-Phillips-McDougall-Study.pdf.
    The United States Trade Representative [USTR], Executive Office of the President, Washington, Mar. 6, 2023, https://ustr.gov/sites/default/files/2023-03/US%20Tech%20Consult%20Request%20March%202023.pdf.
    TODD KUIKEN & JENNIFER KUZMA, GENOME EDITING IN LATIN AMERICA: REGIONAL REGULATORY OVERVIEW (2021).
    （五）網路資料
    About the Coordinated Framework, THE UNIFIED WEBSITE FOR BIOTECHNOLOGY REGULATION, https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/about (last visited June 29, 2023).
    About the Protocol, CONVENTION ON BIOLOGICAL DIVERSITY, https://bch.cbd.int/protocol/background/ (last visited Mar. 29, 2023).
    Adriana Barrera, U.S. Trade Consultations on Mexico`s GMO Corn Rule `Unacceptable Violation` of Law-Mexican Official, REUTERS (Apr. 23, 2023), https://www.nasdaq.com/articles/u.s.-trade-consultations-on-mexicos-gmo-corn-rule-unacceptable-violation-of-law-mexican.
    Consultation Programs on Food from New Plant Varieties, FDA, https://www.fda.gov/food/food-new-plant-varieties/consultation-programs-food-new-plant-varieties (last visited Feb. 26).
    Food, Genetically Modified, WORLD HEALTH ORG. (May 1, 2014), https://www.who.int/news-room/questions-and-answers/item/food-genetically-modified.
    Gene Editing and Agrifood Systems, FOOD AND AGRI. ORG. OF THE U.N. (Jan. 26, 2023), https://www.fao.org/documents/card/en/c/cc3579en.
    History of the Coordinated Framework, THE UNIFIED WEBSITE FOR BIOTECHNOLOGY REGUL., https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/about/about (last visited Feb. 25).
    Human Genome Editing, WORLD HEALTH ORG., https://www.who.int/health-topics/human-genome-editing#tab=tab_1 (last visited Mar. 8, 2023).
    Novelty and Plants with Novel Traits, GOV’T OF CANADA (Aug. 16, 2017), https://inspection.canada.ca/plant-varieties/plants-with-novel-traits/general-public/novelty/eng/1338181110010/1338181243773.
    Smriti Mallapaty, Australiangene-editingrules adopt ‘middleground’, NATURE NEWS (Apr. 23, 2019), https://www.nature.com/articles/d41586-019-01282-8.
    The 17 Goals, UNITED NATIONS, https://sdgs.un.org/goals (last visited June 30, 2023).
    Timothy Eggert, Mexico Issues Revised Decree on GMO Corn, FARMWEEK NOW.COM (Mar. 6, 2023), https://www.farmweeknow.com/policy/national/mexico-issues-revised-decree-on-gmo-corn/article_a867392a-ac96-11ed-aa36-dbc4847695e3.html.
    Understanding the Agricultural Biotechnology Provisions in the U.S.-Mexico-Canada Agreement, INSTITUTION FOR AGRI. & TRADE POLICY (Mar. 2, 2022), https://www.iatp.org/documents/understanding-agricultural-biotechnology-provisions-us-mexico-canada-agreement.
    UNITED NATIONS, Population, available at: https://www.un.org/en/global-issues/population (last visited Feb. 16, 2023).
    Description: 碩士
    國立政治大學
    國際經營與貿易學系
    110351046
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G0110351046
    Data Type: thesis
    Appears in Collections:[Department of International Business] Theses

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