法規內容

下載法規原始檔

 

國立成功大學生物實驗場所設立許可及管理辦法
NCKU Regulations for Establishment Approval and Management of Biological Experiment Sites

102.05.20生物實驗安全委員會通過

Approved by the Biological Experiment Safety Committee on May 20, 2013

102.06.17環境保護暨安全衛生委員會修正通過

Revised and approved by the Occupational Safety and Health and Environmental Protection Committee on June 17, 2013

102.09.18第169次行政會議修正通過

Revised and approved in the 169th Executive Board meeting on September 18, 2013

102.11.27第170次行政會議修正通過

Revised and approved in the 170th Executive Board meeting on November 27, 2013

103.09.24第173次行政會議修正通過

Revised and approved in the 173rd Executive Board meeting on September 24, 2014

 

第一條      國立成功大學(以下簡稱本校)為規範生物實驗場所設立事項,使其符合環境保護及職業安全衛生相關法規規定,以確保教職員工生教學研究之安全,特訂定「國立成功大學生物實驗場所設立許可及管理辦法」(以下簡稱本辦法)。

Article 1   The National Cheng Kung University (the “University”) particularly establishes the NCKU Regulations for Establishment Approval and Management of Biological Experiment Sites (these “Regulations”) in order to govern matters concerning the establishment of biological experiment sites, to meet the requirements of applicable laws and regulations governing occupational safety and health and environmental protection, and to ensure the safety of the faculty, staff, and students during the conduction of education and research.

第二條       本校生物實驗場所之設立許可與管理,依本辦法之規定;本辦法未規定事項,適用其他有關法令規定。

Article 2    The establishment approval and management of biological experiment sites of the University shall be governed by these Regulations. For matters not provided in these Regulations, the relevant provisions prescribed in other acts and regulations shall be applied.

第三條        本辦法所稱生物實驗場所,定義如下:

Article 3     Biological experiment sites referred in these Regulations are defined as follows:

一、凡涉及使用、培養或產生科技部列管之生物材料風險等級第一級(含)以上之實驗場所。

I.     Experiment sites where the use, culture, or generation of Risk group 1(RG 1) and above biological materials governed by the Ministry of Science and Technology are involved.

二、其他依中央主管機關公告指定之生物實驗場所。

II.    Other biological experiment sites announced and designated by the central competent authority are involved.

第四條         本校新設生物實驗場所,應依本辦法規定提出申請,經環境保護暨安全衛生中心(以下簡稱環安衛中心)審核通過後,始得設立及運作。

Article 4       To apply for new biological experiment sites in the University, an application shall be submitted as required herein; once it is reviewed and approved by the Center for Occupational Safety and Health and Environmental Protection (the Center), this experiment site could be established and become operative.

第五條         生物實驗場所申請設立許可,其申請人應為本校專任之教師、研究人員,或經服務系(所)、所屬學術或研究之一級單位審核通過之專任人員。

生物實驗場所經環安衛中心審核通過後,申請人即為該生物實驗場所之負責人。

Article 5       The applicants for the establishment of a biological experiment site shall be a full-time faculty member, researcher, or staff member affiliated in the primary academic or research units at the department/ institute of the University.

Once reviewed and approved by the Center, the applicant for the specific biological experiment site shall be its person in charge.

第六條       申請生物實驗場所之設立,應檢附「生物實驗場所設立申請檢核表」,送所屬一級單位轉送環安衛中心審核。

Article 6     To apply for establishment of a biological experiment site, the “Biological Experiment Site Establishment Application Checklist” shall be enclosed and sent to the affiliated primary unit, which then forward to the Center for review.

前項文件或其他記載事項如不完備,應通知限期補正;限期未補正者,駁回其申請。

When the above documentation or other documented matters are not complete, the Center would ask to complete the make-up procedure before a specified date. If the applicant has not completedthe application before the deadline set by the Center, the application would be rejected.

第七條         環安衛中心審核申請案件時,得視需要邀集相關單位討論決議之。

Article 7      While reviewing applications, the Center may invite related units to join in the discussions before making a decision if necessary.

第八條          生物實驗場所審核通過後,負責人如有異動或場所、安全等級變更時,應於事實發生一個月前主動檢具事由及資料向環安衛中心核備。

Article 8        In case of alteration or any change made to a biological experiment site that has been reviewed and approved, including change in the person in charge or the site or safety level, the application form shall be submitted a month before and then reviewed and filed by the Center.

生物實驗場所負責人於退休或離職前,應負責完成場所內遺留生物材料、化學藥品與其他應報廢儀器設備之清除或提報處理方案,經環安衛中心審核許可。

Prior to retirement or resignation, the person in charge of a biological experiment site shall be responsible for cleaning up biological materials, chemicals, and other instruments or equipment in the biological experiment site. Otherwise, the person in charge of a biological experiment site shall submit the proposal of a solution to be reviewed and approved by the Center.

第九條         生物實驗場所未依本辦法提出申請許可者,經查證屬實,環安衛中心應即勒令停止運作。

Article 9      A biological experiment site for which the establishment is not applied and approved as required herein, once found, shall be mandated by the Center to stop operation.

第十條         生物實驗場所若有違反相關法令規定,負責人除應自負法律責任外,應依本校環境保護暨安全衛生管理要點等相關規定,視其違反情節,予以適當處分。如有嚴重危害之虞,並得由環安衛中心簽請校長核定後,停止該實驗場所運作。

Article 10     In the event that a biological experiment site violates the requirements of applicable laws and regulations, the person in charge, besides being held solely liable before law, shall be subjected to applicable penalties depending on the circumstances involved in the violation as required by the University’s Directions for the Management of Occupational Safety and Health and Environmental Protection. When serious violations are occured, the Center shall report the case to the President, and stop operations in the experiment site under the permission from the President.

第十一條      本辦法適用範圍為本校所屬區域,及以本校名義於所屬區域外以租賃、借用或其他方式設立之生物實驗場所。

Article 11    These Regulations shall apply to biological experiment sites within the territories of the University and those rented, borrowed, or established outside the territories of the University on behalf of the University.

第十二條      本校現已設立之生物實驗場所,應於本辦法實施日起一年內,向環安衛中心提送「生物實驗場所設立申請檢核表」備查;未依期限提送者,依本辦法第九條規定辦理。

Article 12    For existing biological experiment sites, the Biological Experiment Site Establishment Application Checklist shall be filed and submitted to the Center within a year after the enforcement of these Regulations. Violators will be subjected to the punishments according to Article 9 herein.

第十三條      本辦法經生物安全會、環境保護暨安全衛生委員會、主管會報及行政會議通過後,發布實施。修正時亦同。

Article 13    These Regulations are to be enforced after the approval by the Biosafety Committee, the Occupational Safety and Health and Environmental Protection Committee, the Advisory Committee, and the Executive Board. The same procedure to obtain the approval shall be applied while revising these Regulations.

 

 

 

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