法規內容

下載法規原始檔

 

國立成功大學生物安全會設置要點
NCKU Establishment Guidelines for Biosafety Committee

90年9月5日第518次主管會報通過

Approved in the 518th Executive Board meeting on September 5, 2001

99年9月29日第695次主管會報修正通過

Amended and approved in the 695th Executive Board meeting on September 29, 2010

101年10月17日第734次主管會報修正通過

Amended and approved in the 734th Executive Board meeting on October 17, 2012

103年7月16日第767次主管會報修正通過

Amended and approved in the 767th Executive Board meeting on July 16, 2014.

一、為確保生物實驗安全,並維護民眾及生存環境的永續發展,同時因應國內外相關單位的要求,特設置「國立成功大學生物安全會」(以下簡稱本會),並訂定本要點。

I.     The Biosafety Committee of National Cheng Kung University (the “Committee”) and these Directions are established upon the demand from domestic and international authorities concerned to ensure the safety of biological experiments and to maintain sustainable development for the people and their living environment .

二、本會置委員五至十一人。主任委員由副校長擔任,副主任委員由環境保護暨安全衛生中心中心主任擔任,附設醫院生物安全管理委員會副召集人為當然委員,其餘委員由主任委員推薦經校長同意後聘任。主任委員不克出席時,由副主任委員代理。委員任期均為兩年,並應有半數以上委員連任。本會委員為無給職。

II.     The Committee consists of 5 to 11 members. The Chairperson is served by the Vice President of the University while the Deputy Chairperson is served by the Director of the Center for Occupational Safety and Health and Environmental Protection. The Vice Convener for the Biosafety Management Committee of the National Cheng Kung University Hospital is the ex officio member. The other members are to be hired upon approval by the President of the University from candidates recommended by the Chairperson. In case that the Chairperson cannot attend the meeting, the Deputy Chairperson shall act on the Chairperson’s behalf. Each member serves a term of two years and there shall be more than 50% members serving for consecutive terms. Members of the Committee are not paid.

三、本會得置執行秘書一人,由環境保護暨安全衛生中心之生物污染及輻射防護組長兼任。

III.    One Executive Secretary may be set up for the Committee and the position is filled by the Associate Director of the Biological Pollution and Radiation Protection Division under the Center for Occupational Safety and Health and Environmental Protection.

四、本會得設置各任務小組,進行相關案件審查。

IV.    Respective task forces may be set up for the Committee to review related cases.

五、本會任務如下。

V.    The Committee is entrusted with the following missions:

(一) 審核科技部、其他機關或法令規定要求送審之相關計畫或案件。

(I)    To review and approve related projects or proposals that are required by the Ministry of Science and Technology, other authorities, or by acts and regulations.

(二) 審核第一級以上危險群微生物或生物毒素之持有、保存、使用、處分或輸出入。

(II)   To review and approve the specific possession, storage, use, disposition, or importation/exportation of microorganisms or biological toxins classified as Risk Group 1(RG1) or higher risk groups.

(三) 審核使用第一級以上危險群微生物或生物毒素實驗室之生物安全等級。

(III)  To review and approve the biosafety levels of a laboratory with the use of microorganisms or biological toxins classified as Risk Group 1 (RG1) or higher risk groups.

(四) 審核第二等級以上實驗室之新建、改建、擴建、啟用或停止運作計畫。

(IV)  To review and approve the construction, remodeling, expansion, activation, or discontinuation of the operation plan for laboratories of Biosafety Class 2 or higher ones.

(五) 審核實驗室之生物安全緊急應變計畫。

(V)   To review and approve the biosafety emergency response plans of laboratories.

(六) 審核實驗室之生物安全爭議事項。

(V)   To review and approve biosafety disputes in laboratories.

(七) 督導實驗室人員之生物安全訓練與生物安全內部稽核及缺失改善。

(VII) To supervise the biosafety training for laboratory staff, internal biosafety audits and improvements of drawbacks.

(八) 審核及督導其他有關感染性生物材料及實驗室之生物安全管理事項。

(VIII)To review, approve, and supervise other biosafety management matters related to infectious biological materials and laboratories.

(九) 處理、調查及報告實驗室之生物安全意外事件。

(IX)  To cope, demonstrate, and report biosafety accidents in laboratories.

有關動物實驗安全依動物中心規定辦理。

Animal experiment safety issues shall follow the requirements of the Laboratory Animal Center.

六、本會每學年至少召開會議一次,必要時得召開臨時會議。

VI.   The Committee meets at least once a year and may hold provisional meetings when necessary.

七、本會開會時,得邀請相關行政人員或專家列席。

VII.   While the Committee meets, related administrators or experts may be invited to attend these meetings.

八、本設置要點經主管會報通過後實施,修正時亦同。

VIII.  These Directions are to be enforced after approval via the Executive Board meeting. The same procedure to obtain the approval shall be applied while revising these Directions.

 

 

These regulations were translated from the original Chinese. In the event of any discrepancies between the two versions, the Chinese always takes precedence.