Regulations Governing Management of Infectious Biological Materials Article 28

In the event of a biosecurity incident, a laboratory or storage facility shall promptly inform its BSO, and controlled premises shall promptly inform their BSAT officers.Where the incident in the preceding paragraph involves an inconsistency in the item or quantity of stored or transferred Risk Group 2 pathogens or biotoxins other than BSAT, and involves loss, theft, or unknown cause, the entity shall report to the local competent authority for record within seven days from the day following confirmation of the investigation results.Where the incident in Paragraph 1 hereof involves pathogens in Risk Groups 3 or 4, or BSAT, the entity shall report to the competent authorities at all levels within the following timeframe:1. Pathogens in Risk Groups 3 or 4: Within three days from the day following the receipt of a report by the BSO.2. BSAT: Within three days from the day following the receipt of a report by the BSAT officer.With regard to an incident mentioned in the preceding paragraph, the entity shall, within ten days from the day following the discovery of the incident, submit a preliminary investigation report reviewed by its IBC to the competent authorities at all levels for record. In addition, the entity shall, within thirty days from the day following the discovery of the incident, submit an incident investigation report as well as a correction and recovery plan reviewed by its IBC to the central competent authority for approval, with a copy of the same sent to the local competent authority.After receiving a report under Paragraph 2 or Paragraph 3 hereof, competent authorities at all levels shall, as appropriate, conduct supervision or investigation and may take appropriate actions.
中文原文 感染性生物材料管理辦法第28條
實驗室、保存場所發生生物保全事故時,應立即通報生安主管,其為管制作業場所者,應立即通報管制性生物材料主管。
前項事故屬於保存或移轉非屬管制性生物材料之第二級危險群病原體、生物毒素品項或數量不符,且為遺失、遭竊或發生原因不明者,設置單位應於確認調查結果之次日起七日內,報地方主管機關備查。
第一項事故涉及第三級、第四級危險群病原體或管制性生物材料時,設置單位應於下列期限內通報各級主管機關:
一、第三級、第四級危險群病原體:生安主管接獲通報之次日起三日內。
二、管制性生物材料:管制性生物材料主管接獲通報之次日起三日內。
前項事故,設置單位應於發現事故之次日起十日內,檢具經生安會審議之初步調查報告,報各級主管機關備查;並於發現事故之次日起三十日內,檢具經生安會審議之事故調查報告及改善與復原計畫,報中央主管機關核定,並副知地方主管機關。
各級主管機關接獲第二項或第三項通報後,應視狀況督導或調查,並得為適當之處理。

English translation for reference only; the Chinese text prevails. Not legal advice.