Detail of STATECOUNCILORDER-562

Introduction of STATECOUNCILORDER-562

Chapter I General Provisions Article 1The Regulation was formulated according to the "Law of the People's Republic of China on Prevention and Control of Radioactive Pollution" with a view to strengthening the safety administration of transport of radioactive articles, guaranteeing human health, protecting environment and promoting the development and peaceful use of nuclear energy and nuclear technology. Article 2The Regulation is applicable to the transport of radioactive articles and the design, manufacturing and other relevant activities of transport containers for radioactive articles. Radioactive articles involved in the Regulation refer to the articles which contain radionuclides and have both activity and specific activity higher than the exemption values stipulated by the Nation. Article 3The radioactive articles are classified into Categories I, II and III according to their characteristics and the degree of their potential hazards to human health and environment. Category I radioactive articles: the radioactive articles such as Category I radioactive sources, high-level radioactive wastes and spent fuels which will cause great radiation impact on human health and environment after being emitted to the environment. Category II radioactive articles: the radioactive articles such as Categories II and III radioactive sources and intermediate-level radioactive wastes which will cause general radiation impact on human health and environment after being emitted to the environment. Category III radioactive articles: the radioactive articles such as Categories IV and V radioactive sources, low-level radioactive wastes and radioactive drugs which will cause relatively small radiation impact on human health and environment after being emitted to the environment. The specific classification and list of radioactive articles will be prepared by the nuclear safety supervision and management department of the State Council in conjunction with the competent departments in public security, health, customs, transport, railway, civil aviation and nuclear industry of the State Council. Article 4The nuclear safety supervision and management department of the State Council will execute supervision and management over the nuclear and radiation safety during transport of radioactive articles. The relevant competent departments in public security, transport, railway, civil aviation, etc. of the State Council will take charge of the relevant supervision and management work on transport safety of radioactive articles according to the requirements of the Regulation and their respective responsibilities. The environmental protection competent departments of local people's governments at or above the county level and the relevant competent departments in public security, transport, etc. will take charge of the relevant supervision and management work on transport safety of radioactive articles in their own administrative areas according to the requirements of the Regulation and their respective responsibilities. Article 5To transport radioactive articles, special packaging containers for transport of radioactive articles (hereinafter referred to as "transport containers") should be used. The transport of radioactive articles and the design and manufacturing of transport containers for radioactive articles should meet the national standards for transport safety of radioactive articles. The national standards for transport safety of radioactive articles will be formulated by the nuclear safety supervision and management department of the State Council and will be jointly issued by the nuclear safety supervision and management department and the competent standardization department of the State Council. To formulate the national standards for transport safety of radioactive articles, the nuclear safety supervision and management department of the State Council should solicit opinions from the competent departments in public security, health, transport, railway, civil aviation and nuclear industry of the State Council. Article 6The entities engaged in design and manufacturing of transport containers for radioactive articles should establish and improve liability system, strengthen quality management, and also be responsible for their design and manufacturing activities of transport containers for radioactive articles. The consignors of radioactive articles (hereinafter referred to as the "consignors") should formulate nuclear and radiation accident emergency plan, take effective radiation protection and security measures during transport of radioactive articles, and also be responsible for nuclear and radiation safety during transport of radioactive articles. Article 7Any entity or individual is entitled to report the behaviors in violation of the requirements of the Regulation to the nuclear safety supervision and management department of the State Council or other departments which fulfill the supervision and management responsibilities for transport safety of radioactive articles according to law. The department receiving the report should investigate and handle the violation behaviors according to law and should also keep secret for the informers. Chapter II Design of Transport Containers for Radioactive Articles Article 8The entities engaged in the design of transport containers for radioactive articles should establish, improve and effectively implement a quality assurance system, carry out design in accordance with the national standards for transport safety of radioactive articles, and carry out evaluation on safety performance of the designed transport containers for radioactive articles via experimental verification, analytic demonstration, etc. Article 9The entities engaged in the design of transport containers for radioactive articles should establish and improve a filing system, and should faithfully record the evaluation process of the design and safety performance of transport containers for radioactive articles in accordance with the requirements of quality assurance system. To carry out design of transport containers for Category I radioactive articles, the design entities should prepare the design safety evaluation report; to carry out design of transport containers for Category II radioactive articles, the design entities should prepare the design safety evaluation report form. Article 10The design of transport containers for Category I radioactive articles should be submitted to the nuclear safety supervision and management department of the State Council for examination and approval before it is used for manufacturing for the first time. To apply for approval of the design of transport containers for Category I radioactive articles, the design entities should submit a written application to the nuclear safety supervision and management department of the State Council and should also submit the following data: (1) The general design drawing and its design instructions; (2) The design safety evaluation report; (3) The quality assurance program. Article 11The nuclear safety supervision and management department of the State Council should finish examination within 45 workdays upon acceptance of the application, and should issue the approval letter for the design of transport containers for Category I radioactive articles and announce the approval number if the design meets the national standards for transport safety of radioactive articles; and should inform the application unit in written form, together with the rejection reason, if the design fails to meet the national standards for transport safety of radioactive articles. Article 12Should any entity engaged in the design of transport containers for Category I radioactive articles change the safety-related content in the approved design, it will have to apply for the approval letter for design of transport containers for Category I radioactive articles again from the nuclear safety supervision and management department of the State Council according to the original application procedures. Article 13For the design of transport containers for Category II radioactive articles, the design entities should submit the general design drawing and its design instructions and design safety evaluation report form to the nuclear safety supervision and management department of the State Council for record before the design is used for manufacturing for the first time. Article 14For the design of transport containers for Category III radioactive articles, the design entities should prepare the documentary evidence about the conformity of the design with the national standards for transport safety of radioactive articles and should also file it for future reference. Chapter III Manufacturing and Use of Transport Containers for Radioactive Articles Article 15The entities engaged in the manufacturing of transport containers for radioactive articles should carry out quality inspection on the manufactured transport containers for radioactive articles according to the design requirements and the national standards for transport safety of radioactive articles, and should also prepare the quality inspection report. Any transport container for radioactive articles not undergoing the quality inspection or failing to pass the inspection should not be put into use. Article 16The entities engaged in the manufacturing activities of transport containers for Category I radioactive articles should possess the following conditions: (1) Having the professionals appropriate to the manufacturing activities carried out by them; (2) Having the production conditions and inspection means appropriate to the manufacturing activities carried out by them; (3) Having a complete management system and a sound quality assurance system. Article 17The entities engaged in the manufacturing activities of transport containers for Category I radioactive articles should apply for the manufacturing license of transport containers for Category I radioactive articles (hereinafter referred to as the "manufacturing license"). The entity applying for manufacturing license should submit a written application to the nuclear safety supervision and management department of the State Council and should also submit the evidentiary material about its compliance with the conditions specified in Article 16 of the Regulation as well as the model of transport container being applied for manufacturing. It is forbidden to be engaged in the manufacturing activities of transport containers for Category I radioactive articles without holding the manufacturing license or beyond the scope stipulated in the manufacturing license. Article 18The nuclear safety supervision and management department of the State Council should finish examination within 45 workdays upon acceptance of the application, and should issue the manufacturing license and make announcement if the application is eligible; and should inform the application unit in written form, together with the rejection reason, if the application is non-eligible. Article 19The manufacturing license should cover the following contents: (1) The name, domicile and legal representative of the manufacturing entity; (2) The model of the transport container which is approved to be manufactured; (3) The term of validity; (4) The issuance authority, issuance date and No. of manufacturing license; Article 20Should any entity engaged in the manufacturing of transport containers for Category I radioactive articles change its name, domicile or legal representative, it will have to transact the manufacturing license change formalities with the nuclear safety supervision and management department of the State Council within 20 days since the registration of industrial and commercial changes. Should any entity engaged in the manufacturing of transport containers for Category I radioactive articles change the model of transport container manufactured, it will have to apply for the manufacturing license again from the nuclear safety supervision and management department of the State Council according to the original application procedures. Article 21The manufacture licence is valid for 5 years. Should any entity engaged in the manufacturing of transport containers for Category I radioactive articles need to extend the manufacturing license upon the expiration of the term of validity, it will have to submit an extension application to the nuclear safety supervision and management department of the State Council 6 months before the expiration of manufacturing license. The nuclear safety supervision and management department of the State Council should make the decision about approval of the extension before the expiration of manufacturing license. Article 22The entities engaged in the manufacturing activity of transport containers for Category II radioactive articles should submit the evidentiary material about the professionals, production conditions and inspection means appropriate to the manufacturing activities carried out by them as well as a complete management system and a sound quality assurance system to the nuclear safety regulatory authority of the State Council for record30 days before the manufacturing activity starts for the first time. Article 23The entities engaged in the manufacturing activity of transport containers for Category I or II radioactive articles should code the transport containers for Category I or II radioactive articles manufactured by them uniformly in accordance with the coding rules established by the nuclear safety regulatory authority of the State Council, and submit the transport container codes list used in the previous year to the nuclear safety regulatory authority of the State Council for record before every January31. Article 24The entities engaged in the manufacturing activity of transport containers for Category III radioactive articles should submit the models and quantity of the transport containers manufactured in the previous year to the nuclear safety regulatory authority of the State Council for record before every January31. Article 25The using unit of transport containers for radioactive articles should maintain the transport containers for radioactive articles periodically, and establish a maintenance record; if the transport containers for radioactive articles reach their design working life or exist any potential safety hazard, they should be taken out of service and disposed of. The using unit of transport containers for Category I radioactive articles should also carry out an evaluation on safety performance of the transport containers for Category I radioactive articles every 2 years, and submit the evaluation result to the nuclear safety regulatory authority of the State Council for recording. Article 26The entities engaged in using the transport containers for Category I radioactive articles manufactured by foreign entities should submit to the nuclear safety supervision and management department of the State Council for examination and approval before they are used for the first time. The entities applying for using transport containers for Category I radioactive articles manufactured by foreign entities should submit a written application to the nuclear safety supervision and management department of the State Council and also should submit the following data: (1) The copy of the approval document for design issued by the nuclear safety supervision and management department in the country where the design entity operates; (2) The design safety evaluation report; (3) The evidentiary material for relevant performance of the manufacturing entities; (4) The quality certificate; (5) The explanatory material in accordance with the laws and administrative regulations of the People's Republic of China and the national standards for transport safety of radioactive articles or the standards approved by the nuclear safety supervision and management department of the State Council. The nuclear safety supervision and management department of the State Council should finish examination within 45 workdays upon acceptance of the application, and should issue the approval letter for use if it meets the national standards for transport safety of radioactive articles; and should inform the application unit in written form, together with the rejection reason, if it fails to meet the national standards for transport safety of radioactive articles. Article 27The entities engaged in using the transport containers for Category II radioactive articles manufactured by foreign entities should submit the quality certificates of the transport containers and the explanatory material in accordance with the laws and administrative regulations of the People's Republic of China and the national standards for transport safety of radioactive articles or the standards approved by the nuclear safety supervision and management department of the State Council to the nuclear safety regulatory authority of the State Council for record before they are used for the first time. Article 28The nuclear safety regulatory authority of the State Council should determine the codes of transport containers while transacting the examination, approval and recording formalities for the use of the transport containers for Category I or II radioactive articles manufactured by foreign entities.

Contents of STATECOUNCILORDER-562