Regulations Governing Management of Infectious Biological Materials Article 9
An entity shall establish a biosafety and biosecurity management mechanism for infectious biological materials. For infectious biological materials that involve pathogens in Risk Groups 2-4 or biotoxins, the entity shall establish biosafety, biosecurity and emergency response plans in accordance with the items set forth by the central competent authority.Prior to possessing, storing, using, disposing of or importing and exporting pathogens in Risk Groups 2-4 or biotoxins, an entity shall appoint a biosafety officer (hereinafter referred to as “BSO”) and an alternate; an entity with thirty personnel or more shall also set up an institutional biosafety committee (hereinafter referred to as “IBC”). The BSO appointment and IBC setup must be reported to and approved by the local competent authority before the entity may proceed to possess, store, use, dispose of, or import and export pathogens in Risk Groups 2-4 or biotoxins; the same shall apply to any changes thereafter.Prior to possessing, storing, using, disposing of or importing and exporting pathogens or biotoxins mentioned in the preceding paragraph that are classified as BSAT, an entity shall additionally appoint a BSAT officer and an alternate. The appointment must be reported to and approved by the central competent authority before the entity may proceed to possess, store, use, dispose of, or import and export the aforementioned pathogens or biotoxins; the same shall apply to any changes thereafter.The BSAT officer and the BSO shall not be the same person. However, the same person may serve concurrently as both the BSAT officer and the BSO, provided the entity does not possess, store, use, dispose of or import and export non-BSAT.Only an entity that is required to set up an IBC pursuant to Paragraph 2 hereof is allowed to undertake the following activities:1. Possessing, storing, using, disposing of, or importing and exporting pathogens in Risk Groups 3-4 or BSAT.2. Setting up controlled premises under Paragraph 2 of Article 4 herein or a high-containment laboratory under Paragraph 1 of the preceding article.
中文原文 感染性生物材料管理辦法第9條
設置單位應就感染性生物材料，建立生物安全及生物保全管理機制；其涉及第二級至第四級危險群病原體、生物毒素者，應依中央主管機關所定之項目，訂定生物安全、生物保全及緊急應變計畫。
設置單位持有、保存、使用、處分或輸出入第二級至第四級危險群病原體、生物毒素前，應置生物安全主管（以下簡稱生安主管）一人及其代理人，設置單位人員達三十人者，並應設生物安全會（以下簡稱生安會），均報地方主管機關核定後，始得為之；其有異動時，亦同。
設置單位持有、保存、使用、處分或輸出入屬管制性生物材料之前項病原體、生物毒素前，應另置管制性生物材料主管一人及其代理人，於報中央主管機關核定後，始得為之；其有異動時，亦同。
管制性生物材料主管與生安主管，不得為同一人。
但設置單位無持有、保存、使用、處分及輸出入非管制性生物材料者，得為同一人。
依第二項規定應設生安會之設置單位，始得辦理下列事項：
一、持有、保存、使用、處分或輸出入第三級、第四級危險群病原體或管制性生物材料。
二、設立第四條第二項管制作業場所或前條第一項高防護實驗室。
設置單位持有、保存、使用、處分或輸出入第二級至第四級危險群病原體、生物毒素前，應置生物安全主管（以下簡稱生安主管）一人及其代理人，設置單位人員達三十人者，並應設生物安全會（以下簡稱生安會），均報地方主管機關核定後，始得為之；其有異動時，亦同。
設置單位持有、保存、使用、處分或輸出入屬管制性生物材料之前項病原體、生物毒素前，應另置管制性生物材料主管一人及其代理人，於報中央主管機關核定後，始得為之；其有異動時，亦同。
管制性生物材料主管與生安主管，不得為同一人。
但設置單位無持有、保存、使用、處分及輸出入非管制性生物材料者，得為同一人。
依第二項規定應設生安會之設置單位，始得辦理下列事項：
一、持有、保存、使用、處分或輸出入第三級、第四級危險群病原體或管制性生物材料。
二、設立第四條第二項管制作業場所或前條第一項高防護實驗室。