Regulation on the Administration of Transport Safety of Radioactive Articles

Regulation on the Administration of Transport Safety of Radioactive Articles Order of the State Council (No. 562) 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. Premier Wen Jiabao September 14, 2009 Regulation on the Administration of Transport Safety of Radioactive Articles Chapter I General Provisions 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Article 5 To transport radioactive articles, special transport packaging containers for radioactive articles (hereinafter referred to as “transport containers”) shall be used. 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. 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. 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. 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. 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. The departments which have received the reports shall investigate and deal with the cases according to law and keep secret for the informants. . Chapter II Design of Transport Containers for Radioactive Articles 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. 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. 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. 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. 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: (1) the general plan of design and the design description thereof; (2) the design safety evaluation report; and (3) the quality assurance program. 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. 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. 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. 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. Chapter III Manufacturing and Utilization of Transport Containers for Radioactive Articles 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. No transport container for radioactive articles may be delivered for use without quality inspection or if it fails to pass the inspection. Article 16 An entity manufacturing transport containers for radioactive articles of Category I shall possess the following conditions: (1) It has professional technical staff commensurate with the manufacturing it is engaged in; (2) It has production conditions and testing methods commensurate with the manufacturing it is engaged in; and (3) I t has a sound management system and well-established quality assurance system. 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”). 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. 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. 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. Article 19 A manufacturing license shall indicate the following: (1) the name, domicile and legal representative of the manufacturing entity; (2) the type of the transport containers approved to be manufactured; (3) term of validity; (4) the authority issuing the license, issuance date of the license and serial number of the license. 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. 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. Article 21 The manufacturing license shall be valid for five years. 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. 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. 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. 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. 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. 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. 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......