Regulatory Options for Importation of Genome-Edited Foods in Taiwan

臺灣對基因編輯食品進口之管理方案

隨著現代生物技術的快速發展，為能滿足全球對糧食安全和營養日益增長的需求，農產食品行業致力於研發基因組編輯技術，並以此等技術種植之作物為原料從事食品之生產。此等基因編輯食品與傳統上認為安全的食品不同，此等「新興食品」的出現，為食品安全的確保帶來管理層面的挑戰，並衍生出與現有食品安全治理架構相容性的法律問題。儘管基因編輯作物的種植已於世界各國蓬勃發展，但臺灣農業委員會目前採取的政策，原則上係禁止基因改造或編輯作物在田間種植。因此，臺灣境內市場上之基因編輯食品，如果允許的話，應該是從國外進口的為主，從而，針對基因編輯食品之政策制訂與管理壓力，主要將落在臺灣食品藥物管理署身上。在此背景下，本文將探討在現行食品安全管理法制下針對基因編輯食品之進口可能面臨的法律挑戰，並探討臺灣於研訂基因編輯食品政策與管理方案之選擇和考量因素。本文認為，鑑於目前部分對基因編輯技術持開放態度之國家，僅係允許基因組編輯作物之種植，對於供人類食用之食品，臺灣政府對基因組編輯食品的進口可以採取更為謹慎的管理策略。此外，本文建議可以採用依不同技術型態分類的個案管理方法，綜合考量產品屬性與生產過程等因素，並結合早期諮詢程序之機制，期能平衡兼顧此等先進的基因編輯技術領域所涉及的各種政策目標和多重利益。

With rapid advancement in modern biotechnology, the agro-food industry hasbeen engaged in producing foods derived from genome-editing technology to meetthe growing demand for food security and nutrition worldwide. Unlike thosetraditionally recognized as safe, these “novel foods” bring regulatory challenges tothe insurance of food safety and legal issues over consistency with existingframework of food safety governance. Despite the thriving cultivation ofgenome-edited crops worldwide, Taiwan’s Council of Agriculture (COA) adopted thepolicy that neither genetic modified nor edited crops are allowed to plant in thefield. Therefore, the genome-edited food products in Taiwan, if any, will come mostlikely from abroad through importation, and the regulatory pressure will fallstressfully on Taiwan’s Food and Drug Administration (TFDA) rather than the COA.Against such background, this paper will examine possible legal challenges forimporting genome-edited food products under current food laws, and explore policyoptions and considerations for regulation of genome-edited foods in Taiwan. Thispaper argues that Taiwan FDA could adopt a more cautious strategy towardimported genome-edited foods, in contrast to genome-edited crops as currentlypermitted for plantation in some countries. Moreover, a categorical case-by-caseregulatory approach mixed with product-and-process based considerations can beadopted in tandem with early consultation in order to achieve a more balanced outcome in accommodating various policy objectives and multiple interests involvedin the field of newly advanced genome-editing technology