自2005年以降，我國針對是否開放含萊克多巴胺畜產品進口之問題即屬多事之秋，其主因係在食品添加物專家委員會（Joint FAO/WHO Expert Committee on Food Additives，簡稱JECFA）所擬每日容許攝食量下，國際上之相關科學研究無法確切證明萊克多巴胺是否完全安全，抑或其可能對於人體造成之危害及程度，因此多數肉品出口國仍常於家畜飼養過程中添加萊克多巴胺於飼料中，藉以增加畜產品之瘦肉比例並提升經濟效率；另一方面，由於不肖業者違法使用乙型受體素（如克崙特羅、沙丁胺醇）導致人體中毒的案件時有所聞，影響民眾對於畜產品的消費意願及產業發展，是故雖然萊克多巴胺之毒性相較於其他乙型受體素為低，惟受他種毒素高出數倍的乙型受體素之累，在我國自2006年起亦屬禁用之列。在國際食品標準委員會（Codex Alimentarius Commission，簡稱Codex委員會）於去（2012）年以普通多數決之方式制定萊克多巴胺的國際標準後，我國遂修訂食品衛生管理法第11條（2013年新法第15條）、第17-1條 （新法第25條）及動物用藥殘留標準第3條，並公告農防字第1011473960號之行政命令，採行「安全容許、牛豬分離、強制標示、排除內臟」之檢疫政策，在牛肉（含脂肪）的部分採行與國際標準相同之檢疫標準；惟在豬肉及內臟的部分，則為兼顧「國人特殊膳食習慣」及「相關產業發展」，仍維持既有「零檢出」的檢疫政策，全面禁止含萊克多巴胺的畜產品進口。針對此我國特殊之管制作法，本文將以國際經貿法的觀點，依據WTO協定中與檢疫措施最密切相關的SPS協定規範、過往案例之判決及相關文獻，分析我國進口檢疫規定之適法性，藉以思考目前畜產品進口的議題，並判斷該措施將來是否存在遭非難之可能，希冀能對於我國日後檢疫政策走向提供一實質性之參考及展望。 / Since 2005, the issue of liberalizing the import of meat containing Ractopamine had sparked great controversy in Taiwan, resulting from the lack of clear and definite scientific evidences worldwide to prove the harmlessness toward human body under JECFA’s maximal residue level and acceptable daily intake. Owing to the abusing of other much more poisonous Beta-adrenergic agonist (e.g., Clenbuterol, Salbutamol) by some of illegal stockbreeders causing the vibration of meat market and industry, Taiwan’s government had decided to ban the residual of Beta-adrenergic agonist including Ractopamine contained in both domestic and import meat products since 2006. After Codex Alimentarius Commission finally voted through the international standard of Ractopamine in 2012, Taiwan’s Legislative Yuan amended former regulations, approving the import of beef which conformed to Codex’s international standard, while still remained the prohibition of pork containing Ractopamine. This essay staying with the view of international trade law, in particular the Agreement on the Application of Sanitary and Phytosanitary Measures under World Trade Organization, tries to analyze the consistency of Taiwan’s meat regulations with the SPS agreement in order to prospect Taiwan’s trade policy and meat regulations regarding Ractopamine in the future.

在食品貿易全球化的趨勢下，食源性疾病將隨著跨國貿易而擴散，如何在促進貿易的同時亦確保人類食用之安全，即為當今重要之議題。WTO作為涵蓋最多貿易經濟體，並係目前處理國際貿易規則的唯一全球貿易國際組織，對於食品安全與貿易議題，在SPS協定第4條訂有「同等效力」規範作為權衡兩種利益之對策。在國際食品貿易領域下，同等效力係指若進口國對於出口國所採「相異」於進口國本身之SPS措施，如出口國之SPS措施達到與進口國國內「相同」的保護水準，即可認定出口國之措施具備同等效力而承認之，而非要求出口國採用與進口國完全一致之SPS措施。 國際間依據該規範，尤以美國及歐盟為例，實施「輸入前系統性查核機制」，即在食品輸入前先行對出口國之食品安全體系及政府監督措施進行審查，經評估後判定其保護水準與進口國具備同等效力後，該出口國始得出口食品，大幅提升食品安全之保護水準。我國亦順應該趨勢，於民國103年2月11日由衛生福利部公布施行〈輸入食品系統性查核實施辦法〉，將食品安全管制時點從邊境提前至境外。 為瞭解我國規範是否完善，本文將利用比較法的方式，先了解各該國際規範以及美國與歐盟兩大食品貿易國之規範內容，並檢視我國系統性查核機制並提出可能之建議。本文以為，我國已具備同等效力之基本運作架構，惟細部的運作規則、如何判斷同等效力、如何確保後續同等效力之維持，並無明確之規定。故本文建議應先健全我國系統性查核機制之運作及法律機制，以備將來擴大適用。 / With the trend of international trade in food products, foodborne illnesses spread through cross-border trade. Therefore, how to ensure food safety of human consumption while facilitating trade is the most critical issue nowadays. As the only international organization dealing with the global rules of trade between nations, the WTO SPS agreement article 4 provides the “equivalence” mechanism as a way to balance the rights between trade and food safety. In the field of international food trade, the equivalence means that SPS measures does not require duplication or sameness of measures between exporting and importing Members, but the acceptance of alternative measures that meet importing Member's appropriate level of sanitary or phytosanitary protection. Based on the provisions governing equivalence mechanism, each state would implement ante systematic audit, via reviewing food safety system and monitoring measures adopted by competent authorities of exporting party before the importation of food products. As long as the importing state makes a positive determination recognizing of the appropriate level of protection has been achieved, the food products from exporting party are eligible to export to the market of importing state. Such mechanism facilitates cross-border trade in food products and secures the interests of food safety. With this trend, our government enacted the Regulations for Systematic Inspection of Imported Food in recent years. This thesis tries to review the soundness of current Regulation through comparative analysis with international rules and regulations of the US as well as EU. The conclusion is that our system lacks of the specific rules for operation, determination of equivalence and the assurance of the equivalent persistency. Consequently, our government should set up these core elements before transforming current rules to a more comprehensive mechanism in the future.

2009年10月22日，美國在臺協會與駐美國臺北經濟文化代表處簽訂臺美牛肉議定書。對於政府開放美國具牛海綿狀腦病風險之牛肉及牛肉製品進口，當時輿論一片譁然。為因應國內輿論壓力，立法院於2010年1月27日修正食品衛生管理法第十一條，禁止美國牛絞肉及內臟進口。同時政府亦實施三管五卡措施對美國牛肉進行進口檢疫，造成國內法與議定書國際義務不符之現象。 臺美牛肉議定書爭議，牽涉到許多面向，包括：臺美牛肉議定書在我國國內法之地位；我國因應臺美牛肉議定書簽訂所為之食品衛生管理法修法及三管五卡措施在WTO法律架構下之評價；我國與美國之貿易關係等。本文從WTO架構出發，以食品安全檢驗暨動植物防疫檢疫措施協定（SPS協定）之規範探討臺美牛肉議定書爭議在WTO法律架構下應如何評價。並以國際法與國內法間關係之角度探討臺美牛肉議定書在我國國內法之地位，同時討論臺美牛肉議定書爭議對臺美貿易關係之影響。第一章為導論；第二章討論WTO架構中關於具牛海綿狀腦病風險牛肉之規範；第三章討論我國牛肉進口之防檢疫措施及臺美牛肉議定書之規範；第四章討論臺美牛肉議定書之相關爭議；最後，第五章針對臺美牛肉議定書爭議提出政策建議並作結。 / On October 22, 2009, the Taipei Economic and Cultural Representative Office (TECRO) and the American Institute in Taiwan (AIT) signed the US-Taiwan Beef Protocol for the arrangement with regard to the Bovine Spongiform Encephalopathy (BSE)-related measures on importing beef and beef products. Due to lack of confidence in the government, the public opinion of Taiwan was strongly against such importation of beef. In order to deal with the roaring public opinion, the Legislative Yuan of the Republic of China (ROC) amended the Act Governing Food Sanitation Article XI on January 27, 2010. According to this amendment, the beef viscera and ground beef produced in the United States are banned from importing into Taiwan. Furthermore, the ROC government then adopted the Regulation Governing the Sanitation of Importing Beef and several sanitary and phytosanitary measures (SPS measures) to implement the amendment. These measures result in a discrepancy between the obligations regulated by domestic law and those by the Beef Protocol. The issue of the Beef Protocol may be discussed from many aspects, including the legal status of the Protocol in domestic law, the evaluation of the SPS measures under the WTO regime, the US-Taiwan relations, etc. This study will start from the introduction of the SPS Agreement, the international food standard of the BSE-risked beef set by the World Organization for Animal Health (OIE), and the Beef Protocol. Then, the author will discuss the evaluation of the Protocol and other SPS measures of the ROC under the WTO regime and try to figure out the possibility of the use of the Dispute Settlement Body (DSB) in order to solve the Protocol issue. This study will also examine the legal status of the Protocol in the ROC domestic law and discuss the impact on the US-Taiwan commercial relations. In the final part of this study, the author will provide several policy recommendations to settle this Protocol issue.