Regulations for the Field Trial of Transgenic Breeding Livestock (Fowl) and the Bio-Safety Assessment Article 4
The bio-safety assessment should include the following items:1.The objective and background of the study of transgenic breeding stock and fowl2.The Chinese and English terms of the original breeding stock and fowl or genetic resource3.The source and general biological characteristics of the original breeding stock and fowl or genetic resource4.The name, source, characteristics, and sequence of the transgene5.The vector of the transgene6.The theoretical ground of the transferring method, the molecular evidence of the transferred gene, related or similar events both at home and abroad and its bio-safety assessment result.7.The expression location of the transgene in the cells or tissues of the breeding stock and fowl and the stability of its inheritance and expression8.The transgenic breeding stock and fowl’s performances, which include the general characteristics, proliferation methods, feeding and managing methods and things deserving special attention9.The possibility of transgenic breeding stock and fowl to turn into a public hazard and the precautions to be taken against it10. The design of field experiment: it includes the qualitative performance that should be subjected to inspection during the field trial, the explications of the rules of field trial and the precautions against any leak of the transfer gene.11. Other items prescribed for assessment by the review board of the transgenic breeding stock and fowl
中文原文 基因轉殖種畜禽田間試驗及生物安全性評估管理辦法第4條
生物安全性評估之內容包括下列事項：
一、基因轉殖種畜禽之研究應用目的及背景。
二、原始種畜禽或種原之中英文名稱。
三、原始種畜禽或種原來源及一般生物學特性。
四、轉殖基因之名稱、來源、特性及組成。
五、轉殖基因載體。
六、轉殖方法與學理依據、轉殖後標的基因之分子證據及國內外相關或類似事例與其生物安全性評估結果等。
七、轉殖基因在種畜禽細胞或組織之表現位置及基因遺傳與表現之穩定度。
八、基因轉殖種畜禽之特性，包括一般特性、繁殖方式、飼養管理方式及飼養管理應特別注意事項。
九、基因轉殖種畜禽演變成有害動物之可能性及其防堵措施。
十、田間試驗設計：包括觀察試驗期間應調查之性狀表現、田間試驗規則說明及轉殖基因外流防堵措施等。
十一、其他經基因轉殖種畜禽審議小組指定評估事項。
一、基因轉殖種畜禽之研究應用目的及背景。
二、原始種畜禽或種原之中英文名稱。
三、原始種畜禽或種原來源及一般生物學特性。
四、轉殖基因之名稱、來源、特性及組成。
五、轉殖基因載體。
六、轉殖方法與學理依據、轉殖後標的基因之分子證據及國內外相關或類似事例與其生物安全性評估結果等。
七、轉殖基因在種畜禽細胞或組織之表現位置及基因遺傳與表現之穩定度。
八、基因轉殖種畜禽之特性，包括一般特性、繁殖方式、飼養管理方式及飼養管理應特別注意事項。
九、基因轉殖種畜禽演變成有害動物之可能性及其防堵措施。
十、田間試驗設計：包括觀察試驗期間應調查之性狀表現、田間試驗規則說明及轉殖基因外流防堵措施等。
十一、其他經基因轉殖種畜禽審議小組指定評估事項。