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Regulation on the Administration of Transport Safety of Radioactive Articles [Effective]
放射性物品运输安全管理条例 [现行有效]
【法宝引证码】

 
Order of the State Council 

国务院令


(No. 562)
 
(第562号)


The Regulation on the Administration of Transport Safety of Radioactive Articles, which was adopted at the 80th executive meeting of the State Council on September 7, 2009, is hereby promulgated and shall come into force on January 1, 2010.
 
《放射性物品运输安全管理条例》已经2009年9月7日国务院第80次常务会议通过,现予公布,自2010年1月1日起施行。

Premier Wen Jiabao
 
总理  温家宝

September 14, 2009
 
二○○九年九月十四日

Regulation on the Administration of Transport Safety of Radioactive Articles
 
放射性物品运输安全管理条例

 
Chapter I General Provisions 

第一章 总 则


 
Article 1 This Regulation is formulated in accordance with the Law of the People's Republic of China on Prevention and Control of Radioactive Pollution for purposes of strengthening the administration of transport safety of radioactive articles, protecting human health and environment and promoting the development and peaceful utilization of nuclear energy and nuclear technology.   第一条 为了加强对放射性物品运输的安全管理,保障人体健康,保护环境,促进核能、核技术的开发与和平利用,根据《中华人民共和国放射性污染防治法》,制定本条例。

 
Article 2 This Regulation shall apply to the transport of radioactive articles and the design and manufacturing of transport containers for radioactive articles and other relevant activities.   第二条 放射性物品的运输和放射性物品运输容器的设计、制造等活动,适用本条例。

The term “radioactive articles” as mentioned in this Regulation shall refer to the articles containing radioactive nuclide, whose activity and specific activity are both higher than the exemption value set forth by the state.
 
本条例所称放射性物品,是指含有放射性核素,并且其活度和比活度均高于国家规定的豁免值的物品。

 
Article 3 The radioactive articles shall be classified into Categories I, II and III according to their characteristics and their extent of potential hazard to human health and environment.   第三条 根据放射性物品的特性及其对人体健康和环境的潜在危害程度,将放射性物品分为一类、二类和三类。

Radioactive articles of Category I shall refer to the radioactive articles that will cause significant effects of radiation to human health and environment after being discharged into the environment, such as radioactive sources of Class I, high-level radioactive waste and spent fuel.
 
一类放射性物品,是指Ⅰ类放射源、高水平放射性废物、乏燃料等释放到环境后对人体健康和环境产生重大辐射影响的放射性物品。

Radioactive articles of Category II shall refer to the radioactive articles that will cause ordinary effects of radiation to human health and environment after being discharged into the environment, such as radioactive sources of Class II and Class III and middle-level radioactive waste.
 
二类放射性物品,是指Ⅱ类和Ⅲ类放射源、中等水平放射性废物等释放到环境后对人体健康和环境产生一般辐射影响的放射性物品。

Radioactive articles of Category III shall refer to the radioactive articles that will cause minor effects of radiation to human health and environment after being discharged into the environment such as radioactive sources of Class IV and Class V, low-level radioactive waste and radioactive drugs.
 
三类放射性物品,是指Ⅳ类和Ⅴ类放射源、低水平放射性废物、放射性药品等释放到环境后对人体健康和环境产生较小辐射影响的放射性物品。

The specific classification and directory of radioactive articles shall be formulated by the nuclear safety regulatory department under the State Council jointly with the competent departments of public security, health, customs, transport, railways, civil aviation and nuclear industry under the State Council.
 
放射性物品的具体分类和名录,由国务院核安全监管部门会同国务院公安、卫生、海关、交通运输、铁路、民航、核工业行业主管部门制定。

 
Article 4 The nuclear safety regulatory department under the State Council shall conduct supervision and administration of the nuclear and radiation safety in transport of radioactive articles.   第四条 国务院核安全监管部门对放射性物品运输的核与辐射安全实施监督管理。

The relevant competent departments of public security, transport, railways, civil aviation, etc. under the State Council shall, in accordance with this Regulation and their respective functions, be responsible for the relevant supervision and administration of transport safety of radioactive articles.
 
国务院公安、交通运输、铁路、民航等有关主管部门依照本条例规定和各自的职责,负责放射性物品运输安全的有关监督管理工作。

The environmental protection administrative departments and the relevant competent departments of public security, transport, etc. under the local people's governments at and above the county level shall, in accordance with this Regulation and their respective functions, be responsible for the relevant supervision and administration of transport safety of radioactive articles within their respective administrative regions.
 
县级以上地方人民政府环境保护主管部门和公安、交通运输等有关主管部门,依照本条例规定和各自的职责,负责本行政区域放射性物品运输安全的有关监督管理工作。

 
Article 5 To transport radioactive articles, special transport packaging containers for radioactive articles (hereinafter referred to as “transport containers”) shall be used.   第五条 运输放射性物品,应当使用专用的放射性物品运输包装容器(以下简称运输容器)。

The transport of radioactive articles and the design and manufacturing of transport containers for radioactive articles shall conform to the national standards for safe transport of radioactive articles.
 
放射性物品的运输和放射性物品运输容器的设计、制造,应当符合国家放射性物品运输安全标准。

The national standards for safe transport of radioactive articles shall be formulated by the nuclear safety regulatory department under the State Council and be promulgated jointly by the nuclear safety regulatory department under the State Council and the standardization department under the State Council. The nuclear safety regulatory department under the State Council shall, when formulating national standards for safe transport of radioactive articles, solicit opinions of the competent departments of public security, health, transport, railways, civil aviation and nuclear industry under the State Council.
 
国家放射性物品运输安全标准,由国务院核安全监管部门制定,由国务院核安全监管部门和国务院标准化主管部门联合发布。国务院核安全监管部门制定国家放射性物品运输安全标准,应当征求国务院公安、卫生、交通运输、铁路、民航、核工业行业主管部门的意见。

 
Article 6 The entities that design and manufacture the transport containers for radioactive articles shall establish and improve the responsibility system, strengthen the management of quality and be responsible for the design and manufacturing of transport containers for radioactive articles they are engaged in.   第六条 放射性物品运输容器的设计、制造单位应当建立健全责任制度,加强质量管理,并对所从事的放射性物品运输容器的设计、制造活动负责。

The consignors of radioactive articles (hereinafter referred to as “consignors”) shall work out contingency plans for nuclear and radiation accidents, take effective radiation protection and security measures in the transport of radioactive articles, and shall be responsible for the nuclear and radiation safety in the transport of radioactive articles.
 
放射性物品的托运人(以下简称托运人)应当制定核与辐射事故应急方案,在放射性物品运输中采取有效的辐射防护和安全保卫措施,并对放射性物品运输中的核与辐射安全负责。

 
Article 7 Any entity or individual shall be entitled to report the violations of this Regulation to the nuclear safety regulatory department under the State Council or any other department performing the functions of supervision and administration of transport safety of radioactive articles according to law.   第七条 任何单位和个人对违反本条例规定的行为,有权向国务院核安全监管部门或者其他依法履行放射性物品运输安全监督管理职责的部门举报。

The departments which have received the reports shall investigate and deal with the cases according to law and keep secret for the informants. .
 
接到举报的部门应当依法调查处理,并为举报人保密。

 
Chapter II Design of Transport Containers for Radioactive Articles 

第二章 放射性物品运输容器的设计


 
Article 8 A design entity of transport containers for radioactive articles shall establish and improve and effectively implement the quality assurance system, design them according to the national standards for safe transport of radioactive articles, and evaluate the safety performance of transport containers for radioactive articles designed by it through experimental validation, analysis demonstration and other means.   第八条 放射性物品运输容器设计单位应当建立健全和有效实施质量保证体系,按照国家放射性物品运输安全标准进行设计,并通过试验验证或者分析论证等方式,对设计的放射性物品运输容器的安全性能进行评价。

 
Article 9 A design entity of transport containers for radioactive articles shall establish and improve a record system, and truthfully make records of the process of design and safety performance evaluation of transport containers for radioactive articles under the requirements of the quality assurance system.   第九条 放射性物品运输容器设计单位应当建立健全档案制度,按照质量保证体系的要求,如实记录放射性物品运输容器的设计和安全性能评价过程。

When designing transport containers for radioactive articles of Category I, the design entity shall work out a design safety evaluation report. When designing transport containers for radioactive articles of Category II, the design entity shall work out a design safety evaluation report form.
 
进行一类放射性物品运输容器设计,应当编制设计安全评价报告书;进行二类放射性物品运输容器设计,应当编制设计安全评价报告表。

 
Article 10 The design of transport containers for radioactive articles of Category I shall be reported to the nuclear safety regulatory department under the State Council for examination and approval before being manufactured for the first time.   第十条 一类放射性物品运输容器的设计,应当在首次用于制造前报国务院核安全监管部门审查批准。

When applying for an approval of the design of transport containers for radioactive articles of Category I, the design entity shall make a written application to the nuclear safety regulatory department under the State Council and submit the following materials:
 
申请批准一类放射性物品运输容器的设计,设计单位应当向国务院核安全监管部门提出书面申请,并提交下列材料:

 
(1) the general plan of design and the design description thereof; (一)设计总图及其设计说明书;

 
(2) the design safety evaluation report; and (二)设计安全评价报告书;

 
(3) the quality assurance program. (三)质量保证大纲。

 
Article 11 The nuclear safety regulatory department under the State Council shall complete the examination within 45 workdays upon acceptance of an application. If the national safety standards for safe transport of radioactive articles are met, it shall issue a written approval of the design of transport containers for radioactive articles of Category I to the applicant, and announce the approval number; and if the national standards for safe transport of radioactive articles are not met, it shall notify the applicant and give reasons in writing.   第十一条 国务院核安全监管部门应当自受理申请之日起45个工作日内完成审查,对符合国家放射性物品运输安全标准的,颁发一类放射性物品运输容器设计批准书,并公告批准文号;对不符合国家放射性物品运输安全标准的,书面通知申请单位并说明理由。

 
Article 12 Where a design entity revises the contents relevant to safety in the approved design of transport containers for radioactive articles of Category I, it shall, according to the original application procedures, apply to the nuclear safety regulatory department under the State Council for a new written approval of the design of transport containers for radioactive articles of Category I.   第十二条 设计单位修改已批准的一类放射性物品运输容器设计中有关安全内容的,应当按照原申请程序向国务院核安全监管部门重新申请领取一类放射性物品运输容器设计批准书。

 
Article 13 As to the design of transport containers for radioactive articles of Category II, the design entity shall, before putting the design into manufacturing for the first time, file the general plan of design, the design description, and the design safety evaluation report form with the nuclear safety regulatory department under the State Council for archival purpose.   第十三条 二类放射性物品运输容器的设计,设计单位应当在首次用于制造前,将设计总图及其设计说明书、设计安全评价报告表报国务院核安全监管部门备案。

 
Article 14 As to the design of transport containers for radioactive articles of Category III, the design entity shall work out evidential documents proving that the design conforms to the national standards for safe transport of radioactive articles and file them for future reference.   第十四条 三类放射性物品运输容器的设计,设计单位应当编制设计符合国家放射性物品运输安全标准的证明文件并存档备查。

 
Chapter III Manufacturing and Utilization of Transport Containers for Radioactive Articles 

第三章 放射性物品运输容器的制造与使用


 
Article 15 A manufacturing entity of transport containers for radioactive articles shall, according to the design requirements and the national standards for safe transport of radioactive articles, conduct quality inspection of the transport containers for radioactive articles manufactured by it and work out a quality inspection report.   第十五条 放射性物品运输容器制造单位,应当按照设计要求和国家放射性物品运输安全标准,对制造的放射性物品运输容器进行质量检验,编制质量检验报告。

No transport container for radioactive articles may be delivered for use without quality inspection or if it fails to pass the inspection.
 
未经质量检验或者经检验不合格的放射性物品运输容器,不得交付使用。

 
Article 16 An entity manufacturing transport containers for radioactive articles of Category I shall possess the following conditions:   第十六条 从事一类放射性物品运输容器制造活动的单位,应当具备下列条件:

 
(1) It has professional technical staff commensurate with the manufacturing it is engaged in; (一)有与所从事的制造活动相适应的专业技术人员;

 
(2) It has production conditions and testing methods commensurate with the manufacturing it is engaged in; and (二)有与所从事的制造活动相适应的生产条件和检测手段;

 
(3) I t has a sound management system and well-established quality assurance system. (三)有健全的管理制度和完善的质量保证体系。

 
Article 17 An entity manufacturing transport containers for radioactive articles of Category I shall apply for a license for manufacturing transport containers for radioactive articles of Category I (hereinafter referred to as the “manufacturing license”).   第十七条 从事一类放射性物品运输容器制造活动的单位,应当申请领取一类放射性物品运输容器制造许可证(以下简称制造许可证)。

An entity which applies for a manufacturing license shall make a written application to the nuclear safety regulatory department under the State Council, and submit evidential materials proving that it conforms to the conditions as prescribed in Article 16 of this Regulation and the type of the transport containers which it applies for manufacturing.
 
申请领取制造许可证的单位,应当向国务院核安全监管部门提出书面申请,并提交其符合本条例第十六条规定条件的证明材料和申请制造的运输容器型号。

It is prohibited to manufacture transport containers for radioactive articles of Category I without a manufacturing license or beyond the scope specified in the manufacturing license.
 
禁止无制造许可证或者超出制造许可证规定的范围从事一类放射性物品运输容器的制造活动。

 
Article 18 The nuclear safety regulatory department under the State Council shall complete the examination within 45 workdays upon acceptance of an application. If the applicant meets the relevant conditions, it shall issue a manufacturing license, and make an announcement; and if the applicant fails to meet the conditions, it shall notify the applicant and give reasons in writing.   第十八条 国务院核安全监管部门应当自受理申请之日起45个工作日内完成审查,对符合条件的,颁发制造许可证,并予以公告;对不符合条件的,书面通知申请单位并说明理由。

 
Article 19 A manufacturing license shall indicate the following:   第十九条 制造许可证应当载明下列内容:

 
(1) the name, domicile and legal representative of the manufacturing entity; (一)制造单位名称、住所和法定代表人;

 
(2) the type of the transport containers approved to be manufactured; (二)许可制造的运输容器的型号;

 
(3) term of validity; (三)有效期限;

 
(4) the authority issuing the license, issuance date of the license and serial number of the license. (四)发证机关、发证日期和证书编号。

 
Article 20 Where a manufacturing entity of transport containers for radioactive articles of Category I changes its name, domicile or legal representative, it shall, within 20 days from the date of modifying the industrial and commercial registration, go through the formalities for modification of the manufacturing license at the nuclear safety regulatory department under the State Council.   第二十条 一类放射性物品运输容器制造单位变更单位名称、住所或者法定代表人的,应当自工商变更登记之日起20日内,向国务院核安全监管部门办理制造许可证变更手续。

Where a manufacturing entity of transport containers for radioactive articles of Category I changes the type of transport containers manufactured by it, it shall, according to the original application procedures, apply to the nuclear safety regulatory department under the State Council for a new manufacturing license.
 
一类放射性物品运输容器制造单位变更制造的运输容器型号的,应当按照原申请程序向国务院核安全监管部门重新申请领取制造许可证。

 
Article 21 The manufacturing license shall be valid for five years.   第二十一条 制造许可证有效期为5年。

Where the term of validity of a manufacturing license is expired and needs to be renewed, the manufacturing entity of transport containers for radioactive articles of Category I shall, six months before the expiry of the term of validity of the manufacturing license, submit an application for renewal to the nuclear safety regulatory department under the State Council.
 
制造许可证有效期届满,需要延续的,一类放射性物品运输容器制造单位应当于制造许可证有效期届满6个月前,向国务院核安全监管部门提出延续申请。

The nuclear safety regulatory department under the State Council shall, before the expiry of the term of validity of the manufacturing license, make a decision on whether to approve the renewal.
 
国务院核安全监管部门应当在制造许可证有效期届满前作出是否准予延续的决定。

 
Article 22 An entity manufacturing transport containers for radioactive articles of Category II shall, 30 days before the first-time manufacturing activity, file the evidential materials proving that it has professional technical staff, production conditions and testing methods commensurate with the manufacturing it is engaged in and has a sound management system and well-established quality assurance system with the nuclear safety regulatory department under the State Council for archival purpose.   第二十二条 从事二类放射性物品运输容器制造活动的单位,应当在首次制造活动开始30日前,将其具备与所从事的制造活动相适应的专业技术人员、生产条件、检测手段,以及具有健全的管理制度和完善的质量保证体系的证明材料,报国务院核安全监管部门备案。

 
Article 23 A manufacturing entity of transport containers for radioactive articles of Category I or Category II shall, according to the coding rules formulated by the nuclear safety regulatory department under the State Council, uniformly code the transport containers for radioactive articles of Category I or Category II manufactured by it, and file the coding list of transport containers in the previous year with the nuclear safety regulatory department under the State Council for archival purpose prior to January 31 each year.   第二十三条 一类、二类放射性物品运输容器制造单位,应当按照国务院核安全监管部门制定的编码规则,对其制造的一类、二类放射性物品运输容器统一编码,并于每年1月31日前将上一年度的运输容器编码清单报国务院核安全监管部门备案。

 
Article 24 An entity manufacturing transport containers for radioactive articles of Category III shall, prior to January 31 each year, file the type and quantity of the transport containers manufactured by it in the previous year with the nuclear safety regulatory department under the State Council for archival purpose.   第二十四条 从事三类放射性物品运输容器制造活动的单位,应当于每年1月31日前将上一年度制造的运输容器的型号和数量报国务院核安全监管部门备案。

 
Article 25 An entity using transport containers for radioactive articles shall regularly maintain and repair the transport containers for radioactive articles used by it, and establish records of maintenance and repairs. If the transport containers for radioactive articles reach the designed service life, or are found to have security risks, the entity shall stop using them and dispose them.   第二十五条 放射性物品运输容器使用单位应当对其使用的放射性物品运输容器定期进行保养和维护,并建立保养和维护档案;放射性物品运输容器达到设计使用年限,或者发现放射性物品运输容器存在安全隐患的,应当停止使用,进行处理。

An entity using transport containers for radioactive articles of Category I shall also conduct safety performance evaluation once every two years on the transport containers for radioactive articles of Category I used by it, and file the evaluation results with the nuclear safety regulatory department under the State Council for archival purpose.
 
一类放射性物品运输容器使用单位还应当对其使用的一类放射性物品运输容器每两年进行一次安全性能评价,并将评价结果报国务院核安全监管部门备案。

 
Article 26 Where an entity uses the transport containers for radioactive articles of Category I manufactured by any overseas entity, it shall report to the nuclear safety regulatory department under the State Council for examination and approval before the first use.   第二十六条 使用境外单位制造的一类放射性物品运输容器的,应当在首次使用前报国务院核安全监管部门审查批准。

The entity which applies for using the transport containers for radioactive articles of Category I manufactured by an overseas entity shall submit a written application to the nuclear safety regulatory department under the State Council and submit the following materials:
 
申请使用境外单位制造的一类放射性物品运输容器的单位,应当向国务院核安全监管部门提出书面申请,并提交下列材料:

 
(1) the photocopy of the design approval document issued by the nuclear safety regulatory department of the country where the design entity is; (一)设计单位所在国核安全监管部门颁发的设计批准文件的复印件;

 
(2) a design safety evaluation report; (二)设计安全评价报告书;

 
(3) evidential materials of the relevant performance of the manufacturing entity; (三)制造单位相关业绩的证明材料;

 
(4) the quality certificate; and (四)质量合格证明;

 
(5) explanation materials proving that the transport containers conform to the laws and administrative regulations of the People's Republic of China and the national standards for safe transport of radioactive articles or the standards recognized by the nuclear safety regulatory department under the State Council.
......
 (五)符合中华人民共和国法律、行政法规规定,以及国家放射性物品运输安全标准或者经国务院核安全监管部门认可的标准的说明材料。
......

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