新興精準育種技術衍生食品之國際管理規範現況研析   全文下載

Study on International Policies and its Countermeasures of New Breeding Techniques Foods

為因應極端氣候、農業疫病、營養健康等需求，使得新興生物技術迅速發展，許多突破性的創新研發成果亦陸續孕育而出，其中新興精準育種技術因為能夠在不含外源基因的情況下，快速且精準的改變生物體內特定基因序列，因此受到世界各國矚目。新興精準育種技術可依送入的模板序列，以及細胞內修復機制的不同，分為寡核苷酸定點突變技術（oligonuclease directed mutagenesis, ODM）和定點核酸酶技術（site-directed nucleases, SDN）兩大類。目前各國對新興精準育種技術產品之管理方式並不一致，且僅有少數國家提出明確的管理規範。加拿大將其視為新穎性作物，以個案審查的方式管理；歐盟法院判決其衍生產品應以基因改造產品管理；美國農業部、日本及阿根廷可經由遞交產品相關文件予主管機關，確認該產品是否受到列管；澳洲及紐西蘭則是將部分新興精準育種技術產品以基因改造產品管理。在目前各國管理規範尚未明朗的情況下，如何不過度嚴格的管理以致錯失創新生物技術發展的機會下，制定妥適的新興精準育種技術管理規範，將是其他國家與我國政府所需面臨的課題。

In order to cope with extreme weather, agricultural diseases, nutritional health and other needs, new biotechnologies have developed rapidly, and many breakthrough innovations have also been bred. The new breeding techniques can be used without foreign genes, and change the specific gene sequence in the organism quickly and precisely, hence, it brought global attention. This new breeding techniques can be divided into two categories, oligonucleotide directed mutagenesis and site-directed nuclease technology, which are different in templates and cell repair mechanism. At present, the regulation on new breeding techniques product is not uniform globally, and only a few countries have clear management regulations. Canada views new breeding techniques products as novel crops and manages them on a caseby-case basis. The European Court of Justice has declared that new breeding techniques products should be managed as genetically modified products. The United States Department of Agriculture, Japan, and Argentina allow submission of product-related documents to the competent authority for confirmation on whether the product is regulated. In Australia and New Zealand, some new breeding techniques products are managed by genetically modified products. Without clear regulation on new breeding techniques products, many research and development companies and academic institutions have already invested a lot of money and effort to develop new breeding techniques technology products. Hence, appropriate new breeding techniques management regulation will be the subject that other countries and our government need to face.