探討國際基因體編輯作物相關法規發展趨勢

Study on the Development Trends of Relevant Regulations in Genome Editing Crops

陳韋竣(Wei-Chun Chen) ； 杜宜殷(Yi-Yin Do)

《作物、環境與生物資訊》 15卷2期 (2018/06) Pp. 79-92

https://doi.org/10.30061/CEB.201806_15(2).0003

摘要

近年國際間已有數種以基因體編輯或稱基因編輯(genome editing or gene editing)技術育成之作物新品系研發成功，並進行全球產業布局。基因編輯為應用生物體內修復核酸機制，對基因體特定序列進行不同程度修飾之分子生物技術之總稱，不同基因編輯策略可對作物基因體之目標序列特定位點進行鹼基對置換、刪除或加入少量核苷酸、刪除或加入具功能之序列或基因等類型。然而基因編輯技術隸屬分子生物技術，以此類技術育成之作物向來為利害關係人(stakeholders)關注之焦點。目前各國家既有管理分子生物技術衍生作物產業利用之相關法規，多數尚需釐清如何以法規定義不同策略所育成的基因編輯作物，以制定適當分級管理方式。美國及加拿大審查分子生物技術衍生作物，以產品特性為基礎，其既有法規及風險評估方法已適用於審查基因編輯作物。其他國家法規則多以製程為管理基礎，其中阿根廷增訂補充條文以辨別基因編輯作物是否涉及遺傳物質新組合或帶有外源基因，而須以基因改造作物相關法規管理之條件。澳洲擬定不同法規管理程度之方案並分析其差別及利弊，後續募集公眾意見作為政策調整之依據。歐盟討論基因編輯作物中點突變型式，是否適用於其對基因改造作物環境釋放管理法規中，豁免誘變技術育成之作物。世界各國對基因編輯作物之法規修訂走向，對研究、產業發展以及國際貿易有決定性影響，因此持續關注各國法規趨勢有其必要性，以促使此技術於育種之應用發展能與國際接軌。

關鍵字

基因編輯 ； 寡核苷酸介導誘變 ； 定位核酸酶 ； 新興植物育種技術 ； 風險評估 ； 生物安全

並列摘要

Recently, several new crop varieties were successfully produced by genome editing techniques in some countries and expected to be launched in global market for industrial use. Genome editing techniques utilize the nucleic acid repair systems in organisms to trigger site-directed genome alterations. Different strategies may involve site-directed base pair substitution, deletion or addition of a few nucleotides/a specific sequence of nucleotides/ functional genes. However, genome editing techniques were classified as a type of molecular biotechnology techniques and its derivative organisms were concerned by stakeholders globally. Regulations for genome-edited crop products are still under deliberation in order to find a suitable management approach in most countries. The United State and Canada have reviewed biotechnology-delivered crops by product-based approaches, their existing regulations are appropriate for evaluating genome-edited crops. On the other hand, other countries implement process-based regulations. Among these countries, Argentina adopted a resolution to distinguish whether a genome-edited crop involving in a recombination event with foreign genetic materials, as a genetically modified organism. Australia has formulated different options for regulating genome-editing organisms and open public discussions are taken into considerations for the policy intent. The European Union discussed whether genome-editing crops obtained by mutagenesis are exempted from regulations on the deliberate release into the environment. Scenario of the global regulatory status of genome-edited crops may impact the development of research, industry, and international trade. Therefore, the trend of relevant regulations in different countries should be close followed and addressed to public for promoting the application of genome editing techniques in crop breeding and geared to international innovation networks in the near future.

並列關鍵字

Gene editing ； Oligonucleotide-directed mutagenesis ； Site-directed nucleases ； New plant breeding techniques ； Risk assessment ； Biosafety