| 中文摘要 |
本計畫的目的在於收集各國的養殖水產品安全管理制度相關法規，並加以彙整比較之間的共通點及差異性，進一步提供建議給政府相關施政單位參考。為使計畫順利執行且提升效率，特別選定我國主要養殖產業的競爭國及輸入國為研究對象，包括歐盟、美國、日本、中國大陸、韓國及俄羅等地區及國家。因各國養殖水產品法規的訂定、編排及執行方式均不同，也增加彙整的困難性與深度，目前則以養殖水產品的管轄機構、進出口管制單位、衛生與藥物殘留檢驗標準、檢疫品項、養殖場管理及驗證制度要求等六大面向，作為法規彙整的主軸，期能提共政府及養殖業者清晰、透明的資訊，避免國際間貿易糾紛的發生。整體而言，各個國家的法規制定機關、衛生安全標準單位及進出口管制機構，均不盡相同，台灣亦是如此，缺乏橫向溝通與聯繫不足，易造成多頭馬車、各行其是。在檢驗及檢疫標準方面，雖其編排方式迥異，但其規定仍包含重金屬、微生物、天然毒素、環境汙染、養殖用藥、寄生蟲、疾病感染甚至其他營養添加劑等。至於養殖場的管理，仍以歐盟的標準最為嚴苛，特別是實施GLOBAL GAP的養殖場，亦須考量動物福祉及員工健康的議題，令其他亞洲國洲國家望塵莫及。總而言之，任何已開發國家法規的制定，均對其水產品的來源、加工廠的規範、運輸的過程、最終販售的方式及其追溯性的執行有詳盡的規定，以供業者查詢。也冀望藉此計畫，讓台灣水產養殖業者隨時掌握即時資訊，在未來國際舞台上更具競爭力。
國際間的貿易日益頻繁，再加上消費者意識抬頭，各國政府莫不戰戰兢兢地為己國人民「食之安全」嚴格把關。目前全世界有八十多個國家和地區從事水產養殖事業，其中亞洲的中國、臺灣、泰國和菲律賓是主要生產國。臺灣面臨水土資源限制及成本高漲挑戰，以及中國和東南亞等開發中國家養殖漁業競爭，使臺灣養殖漁業面臨競爭壓力。本計畫收集及比較我國主要養殖輸出國之漁產品品質之衛生法規比較與我國漁產品管理制度之差異，並草擬相關規範建議；透過當前國內外水產品產銷履歷標準與規範內容加以分析比較，評估標準整合之可行性；最後，透過蒐集我重要養殖魚類主要競爭國之漁產品管理制度之差異、檢視我國相關管理法規草案之完整性及與國際規範符合性，進而提出我國養殖漁產品管理制度與法規草案之建議，希冀讓國內認證水產品能在未來順利與國際制度接軌，提升我國水產品認驗證制度之國際化。
由於國內外食品安全問題的發生頻繁，從常見的食物中毒到近年來歐美狂牛症、農藥殘留、養殖魚或畜禽用藥不當導致藥物殘留等問題。因此，食品安全相關的要求與規範日益重要，並已陸續推動HACCP、GAP與產銷履歷資訊等各類食品貿易認證的管理規範。
在國內消費者健康與食品安全意識日漸抬頭的今日，有關食品品質、安全、衛生逐漸受到重視，包括ISO22000 之品保制度、CAS 和GMP 認證、危害分析重要管制點（HACCP）之食品安全系統皆已被消費者列為做為優質水產品的必要條件。農委會自2004年起著手整合其過去推動之各種優良農產品標章〈包括海宴、吉園圃、有機農產品等〉為CAS標章，並統籌以CAS標章推廣。行政院農業委員會為符合「品牌驗證」之世界潮流，就「農場至餐桌」的概念進行全程管理，於2007年1月29日公布實施「農產品生產及驗證管理法」，規範產銷履歷農水畜產品(TAP)、有機農水畜產品(OTAP)及優良農水畜產品(UTAP)三大驗證制度，並於2007年6月29日發布「農產品標章管理辦法」，訂定UTAP優良農產品標章、OTAP有機農產品標章及TAP產銷履歷農產品標章。並修正「農產品標章管理辦法」第7條及第3條附件1至附件3，將CAS優良農產品標章及CAS有機農產品標章納入，透過公正的第三機構層層關卡的審核與追蹤，幫助消費者把關水產品的安全，進而維護消費者健康與權益。
而在國際間的貿易日益頻繁，再加上消費者意識抬頭下，世界各國對水產品陸續推動各類水產品貿易的管理規範，使漁業生產者獲得之合理價格及消費者能購食品質良好、衛生安全之魚貨。各國政府部門均有自訂衛生法規，進行管理及監控所生產之生鮮漁穫及加工產品，避免生產原料因不當之運送、生產、加工、儲藏而導致危害事件發生。因此然而，各國國情生產環境，漁撈器具、船隻、魚市場、加工廠，甚至終端販售商場等條件之落差甚大。
在我國加入WTO後，如何因應渠等國際間貿易食品安全品質的規定，及提昇我國國內業者之水準以加強國際間競爭力，係我國政府部門和業界關切的重點。
雖然像HACCP制度在各國已行之有年，然因之客觀的環境不同，要求亦有差別，導致食品廠商雖已通過本國HACCP之認證，然外銷至它國時仍發生抽驗不合格，遭受退櫃之命運，造成國際間之貿易糾紛。儘管目前聯合國codex已整合HACCP及ISO9000衍生出新的ISO22000之食品衛生管理制度，但各國目前仍未全面採用新制。除此之外，其他的漁產品管理制度層面，各國主管及相關輔導單位亦不盡相同，如、BAP、Friend of Sea、JAS、Global GAP、China GAP等採自主性的認驗證管理或半強迫性的要求業者執行相關制度。
本研究除整理及介紹目前國內施行的有關食品認證之相關制度如GMP、TGAP、OTAP、CAS及HACCP等驗證規範外，並蒐集國外主要水產養殖之驗證相關制度如ACC/GAA之BAP、Friend of the sea、JAS、輸歐盟漁產品、Global GAP、ISO 22000、FAO及China GAP等各國主要水產品驗證制度之標準，並與我國產銷履歷驗證制度規範(TGAP)進行個別比較。
結果顯示，我國水產養殖場之TGAP驗證規範在養殖場產權及合法性、養殖場環境與水源、生產者資訊、生產操作管理、水質管理與監測、疾病防治與控管用藥、產品運輸管理、產品追溯資訊、食品安全等項目可與國際規範接軌，但在動物防逃措施、環境保護、廢水與廢棄物處理、員工健康和福利、動物健康和福利、災害預防措施方面則無規範。
台灣在漁業（特別是水產養殖及水產種苗等）上的成就在國際上有目共睹，因此有關水產養殖場之驗證制度，朝對於符合環境維護、動物福利、員工健康及國際食品安全規範與相關認驗證制度之方向努力。
開發一套用ELISA方式來偵測水產品抗生素殘留的快篩系統,希望可以提供產業界水產品進出口快篩所需。然而它的敏感度須符合目前國際標準之下。除此之外此套組不需要專業訓練人才即可操作,整體反應時間預計在一小時以下,將可大幅縮短等待檢驗報告時間,增加台灣水產品出口競爭力。本計劃已針對抗體部分, 利用半抗原HXA來修飾抗生素(OTC 和 oxonolic acid)的化學結構再與純蛋白的分子載體(protein carrier)結合,竟而獲得新的免疫原性,並能刺激動物產生相應的抗體. 此計劃將注射兔子來製作高品質的單株抗體及多株抗體供ELISA套組使用,接著再以ELISA的方式測試其差異性以選得敏感性及專一性最好的抗體供後續實驗的使用。我們也將利用標準樣品來製作標準曲線,同時並以其他抗生素及其衍生物測試其敏感性及專一性。後續的實驗將進行添加魚體與抗生素的混合,之後魚體的樣本將利用ELISA套組偵測,比對較早前預備的標準曲線,我們可以得到檢體回收率及敏感性等結果。之後再實際操作以確立本快篩技術的可信度。 |
| 英文摘要 |
The objective of present sub-project is to collect and coordinate the sanitary and safety regulation of aquaculture products from some selected countries and area. Try to illustrate the common features and differences among those regulations and provide constructive comments to our government and industries. For the sake of increasing the efficacy of project execution, we selected those countries which show more competition with our aquaculture industries or our major seafood imported countries as our subjects, including China, South Korea and Russia. Due to the variation of formulation, scheduling and implementation of aquaculture product regulation, it’s more difficult for us to organize those regulations from different countries. However, we initiated this project from collecting those regulation in related to Authority, Jurisdiction unit, Import and Export Regulatory Agency, Sanitation and Drug Residue Standards, Quarantine Standards, Aquaculture Farm Management and Requirement of Certification System as our main axle. We hope provide more important, dynamic and transparent information to our government and industries, to avoid the occurrence of international trading conflict. Conclusively, those organizations, Authority, Jurisdiction unit, Import and Export Regulatory Agency, for aquaculture regulation are not unique, and it resulted in deficient communication and contact and creates no common rules can be followed. In inspection and quarantine standards, it includes examination of heavy metals, microorganisms, natural toxins, environmental pollutions, parasites, disease infection and nutrient additives, even though the aquaculture regulation compiling is quite different among countries. Moreover, the management of aquaculture farm is more strictly regulated in EU countries, especially for GLOBAL GAP certified aquaculture farm. Those farms are requested to concern the animal welfare and employee’s health issue and it’s dramatically difficult for Asian countries to do so. In brief, the identification the resource, processing unit, transportation, final marketing style and traceability of aquaculture products are strictly addressed in developed countries for industrial inquiry. In conclusion, we would like to provide the dynamic information for our government and aquaculture industries and strengthen their competition at the international scene.
Not only the massively international trading but the increase of consumer’s concepts, the government addresses more attention to the issue of “food safety” for the protection of occurrence of food toxicity incidence. There are more than 80 countries developing aquaculture, and Thailand, and Philippine are the main aquaculture countries in Asia. Taiwan is now facing the rising costs, constraints, and challenges of land and water resource. As well as the competition of China and the developing countries in Southeast Asia, the competitive pressures faced by aquaculture in Taiwan is higher and higher. The main objectives of the current project are focus on? the collection and translation of food hygienic regulations from our exported countries, and comparison the gap on seafood quality control systems between Taiwan and exported countries. Also, collect and analysis the seafood certification marks of other countries and organizations, and also compares the standards between
Taiwan and international regulations and guidelines. Finally, we overview
the integrity of the regulations and the international regulatory compliance of Taiwan. And finally make the recommendation about the aquaculture management system and regulations of Taiwan. The results will not only reorganize the deficiency of pervious Taiwan seafood certification marks, but also provide the information regarding the certification standard and process for the conformity and connection of other international certification marks.
Development of a fast screening ELISA method that used to detect antibiotic residues in aquatic products by providing quick screening system for import and export of aquatic products industry needs. By the way, the sensitivity of its subject must under current international standards. In addition, this kit does not require professional training personnel to operate, the overall response time less than an hour are expected, this will significantly shorten the waiting time of inspection reports, to increase the competitiveness of Taiwan's export of aquatic products. We modified the OTC and oxolinic acid structure by adding hapten HXA which can elicit an immune response only when it attached to a large carrier such as a protein. This antibody is expected to produce high-quality monoclonal antibodies and polyclonal antibodies that used for the ELISA kit, followed by ELISA testing the difference between the selection of the best sensitivity and specificity for the following experiments used. We also will use the standard sample to produce the standard curve, and also to other antibiotics and their derivatives to test their sensitivity and specificity. |