Regulations on the Safety and Protection of Radioisotopes and Radiation Devices (2019 Revision)

Regulations on the Safety and Protection of Radioisotopes and Radiation Devices (2019 Revision) Regulations on the Safety and Protection of Radioisotopes and Radiation Devices (Promulgated by the Order No. 499 of the State Council of the People's Republic of China on September 14, 2005; revised in accordance with the Decision of the State Council on Amending Some Administrative Regulations on July 29, 2014; and amended in accordance with the Decision of the State Council to Amend Certain Administrative Regulations on March 2, 2019) Chapter I General Provisions Article 1 This Regulation is formulated for purposes of strengthening the supervision and administration of the safety and protection of radioisotopes and radiation devices, promoting the safe application of radioisotopes and radiation devices, safeguarding the human health and protecting the environment. Article 2 The production, sale and use of radioisotopes and radiation devices as well as the transfer, import and export of radioisotopes within the territory of the People's Republic of China shall be governed by this Regulation. The term “radioisotopes” as mentioned in this Regulation shall include radioactive sources and unsealed radioactive substances. Article 3 The department of ecology and environment of the State Council shall conduct the unified supervision and administration on the safety and protection of radioisotopes and radiation devices throughout this country. The public security department, health department and other departments of the State Council shall, in accordance with their respective functions and the provisions of this Regulation, conduct the supervision and administration on the safety and protection of relevant radioisotopes and radiation devices. The departments of ecology and environment and other relevant departments of the local people's governments at and above the county level shall, in accordance with their respective functions and the provisions of this Regulation, conduct the supervision and administration on the safety and protection of radioisotopes and radiation devices within their respective administrative areas. Article 4 The state shall implement the classified administration of radioactive sources and radiation devices. In accordance with the degree of potential harm of radioactive sources and radiation devices to human health and environment, radioactive sources may be divided, from high to low, into Class I, Class II, Class III, Class IV and Class V, and the specific measures for the classification thereof shall be formulated by the department of ecology and environment of the State Council; radiation devices may be divided into Class I, Class II and Class III, and the specific measures for the classification thereof shall be formulated by the department of ecology and environment of the State Council in consultation with the competent department of health of the State Council. Chapter II Licensing and Filing Article 5 The entities producing, selling and using radioisotopes and radiation devices shall obtain the relevant licenses in accordance with the provisions of this Chapter. Article 6 Except for entities using Class I radioactive sources for medical purposes or preparing radioactive pharmaceuticals for positron emission tomography for their own use, the licenses for entities producing radioisotopes, selling and using Class I radioactive sources or selling and using Class I radiation devices shall be issued by the department of ecology and environment of the State Council upon examination and approval. The licenses for entities other than those whose licenses shall be issued by the department of ecology and environment of the State Council upon examination and approval shall be issued by the departments of ecology and environment of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government upon examination and approval. The department of ecology and environment of the State Council shall, before issuing a license to an entity producing radioisotopes, print and submit the application materials to the competent industry department governing the applicant for opinions. The department of ecology and environment shall notify the public security department and competent department of health at the same level about the examination and approval of license applications and issuance of licenses. Article 7 To apply for a license, an entity producing, selling or using radioisotopes or radiation devices shall meet the following conditions: (1) having the professional technicians appropriate for its scale of production, sale or use, who have the corresponding expertise and protection knowledge and meet the health conditions; (2) having the places, facilities and equipment meeting the national environmental protection standards, occupational health standards and safety and protection requirements; (3) having a special safety and protection management body or full-time or part-time safety and protection managers, equipped with necessary protective equipment and monitoring instruments; (4) having sound safety and protection management regulations and rules and emergency response measures for radiation accidents; and (5) If generating radioactive waste gas, waste liquid or solid waste, having the treatment capacity or having a feasible treatment plan to ensure that the radioactive waste gas, waste liquid or solid waste are discharged up to the standard. Article 8 An entity producing, selling or using radioisotopes or radiation devices shall apply, in advance, for a license to the department of ecology and environment with the examination and approval power, and submit the evidential materials meeting the conditions as prescribed in Article 7 of this Regulation. A medical or health institution using radioisotopes or radiation devices for radiation diagnosis and therapy shall also obtain an institutional license for radioactive source diagnosis and therapy technologies and medical radiation. Article 9 The department of ecology and environment shall, within 20 workdays from the acceptance of an application, complete the examination. If the conditions are met, it shall issue a license to the applicant and make an announcement; otherwise, shall notify the applicant in writing and give reasons. Article 10 A license shall mainly contain: (1) the name, address and legal representative of the entity; (2) the types and scope of activities of the entity; (3) the term of validity; and (4) the date of issuance and serial number of the license. Article 11 Where an entity holding a license changes its name, address or legal representative, it shall, within 20 days from the date of modification registration, apply to the original license-issuing authority for conducting the license modification formalities. Article 12 Under any of the following circumstances, an entity holding a license shall, under the original application procedures, reapply for a license: (1) changing the types or scope of its activities; or (2) newly constructing, reconstructing or expanding any facility or place for production, sale or use. Article 13 A license shall be valid for five years. If the term of validity of a license needs to be renewed at the expiry of it, the entity holding the license shall, 30 days prior to the expiry of the term of validity of the license, submit an application for renewal to the original license-issuing authority. The original license-issuing authority shall, from the day of acceptance of the renewal application and before the expiry of the term of validity of the license, complete the examination. If the conditions are met, the original license-issuing authority shall renew the license; otherwise, shall notify the applicant in writing and give reasons. Article 14 Where an entity holding a license terminates, partially or wholly, its activities of production, sale or use of radioisotopes or radiation devices, it shall submit an application to the original license-issuing authority for partial modification or cancellation of the license, and the original license-issuing authority shall modify or cancel the license upon verification. Article 15 It shall be prohibited to be engaged in the production, sale or use of radioisotopes or radiation devices without a license or in violation of the types and scope as specified in a license. It shall be prohibited to forge, tamper or transfer a license. Article 16 The competent department of foreign trade of the State Council shall, jointly with the department of ecology and environment of the State Council, the General Administration of Customs and the competent industry department governing the entities producing radioisotopes, formulate and publish a catalogue of radioisotopes restricted from import and export and a catalogue of radioisotopes prohibited from import and export. For the import of any radioisotope which is listed in the catalogue of radioisotopes restricted from import and export, the competent department of foreign trade of the State Council shall, after the examination and approval of the department of ecology and environment of the State Council, issue an import license according to the relevant provisions of the state on foreign trade. For the import of any radioisotope outside the catalogue of radioisotopes restricted from import and export and the catalogue of radioisotopes prohibited from import and export, the import formalities shall be handled according to the relevant provisions of the state on foreign trade. Article 17 To apply for importing any radioisotope which is listed in the catalogue of radioisotopes restricted from import and export, the applicant shall meet the following requirements: (1) The importing entity has obtained a license corresponding to its activities; (2) The importing entity has a plan for disposing of the imported radioisotopes after the expiry of their usage period; if Class I, Class II or Class III radioactive sources are imported, it shall have a document of commitment that the original exporter is responsible for recovery; (3) The imported radioactive sources shall have clear labels and necessary descriptive documents; the labels of Class I, Class II and Class III radioactive sources shall be engraved on the bodies or the sealed shells of the radioactive sources, and the labels of Class IV and Class V radioactive sources shall be recorded in the corresponding descriptive documents; and (4) If the imported radioisotopes are sold to any other entity for use, the importing entity shall have a written agreement concluded with the entity using them and a photocopy of the license obtained by the entity using them. Article 18 An entity importing any radioisotope which is listed in the catalogue of radioisotopes restricted from import and export shall submit an import application to the department of ecology and environment of the State Council, and provide the evidential materials meeting the requirements of Article 17 of this Regulation. The department of ecology and environment of the State Council shall, within 10 workdays from the day of acceptance of an application, complete the examination. If the conditions are met, it shall make an approval; otherwise, shall notify the applicant in writing and give reasons. The customs office shall handle the relevant import formalities based on the import license for radioisotopes. Where the packaging materials of the imported radioisotopes are subject to quarantine according to law, the quarantine shall be implemented in accordance with the relevant laws and administrative regulations of the state on quarantine. For any imported radioactive source, the department of ecology and environment of the State Council shall determine the radioactive source code corresponding to its label at the same time. Article 19 To apply for transferring radioisotopes, the applicant shall meet the following requirements: (1) The entities as the transferor and transferee shall hold the licenses corresponding to their activities; (2) The entity as the transferee shall have a plan for disposing of the radioisotopes after the expiry of their usage period; and (3) Both parties to the transfer shall have concluded a written agreement on the transfer. Article 20 To transfer radioisotopes, the entity as the transferee shall submit an application to the department of ecology and environment of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located, and provide the evidential materials meeting the requirements of Article 19 of this Regulation. The department of ecology and environment of the people's government of the province, autonomous region or municipality directly under the Central Government shall, within 15 workdays from the day of acceptance of the application, complete the examination. If the conditions are met, it shall make an approval; otherwise, shall notify the applicant in writing and give reasons. Article 21 The entities as the transferor and transferee of radioisotopes shall, within 20 days from the day of completion of the transfer, file a report on the transfer respectively with the departments of ecology and environment of the people's governments of provinces, autonomous regions or municipalities direct under the Central Government where they are located. Article 22 An entity producing radioisotopes shall maintain an account book of radioisotope products, and in accordance with the coding rules of the department of ecology and environment of the State Council, uniformly code its produced radioactive sources. The account book of radioisotope products and the coding list of radioactive sources shall be filed with the department of ecology and environment of the State Council. The produced radioactive sources shall have clear labels and necessary descriptive documents. In particular, the labels of Class I, Class II and Class III radioactive sources shall be engraved on the bodies or the sealed shells of radioactive sources, and the labels of Class IV and Class V radioactive sources shall be recorded in the corresponding descriptive documents. The department of ecology and environment of the State Council shall be responsible for establishing a radioisotope filing information management system to share information with the relevant departments. The radioisotopes not included in the product account book and uncoded radioactive sources shall not leave factory and be sold. Article 23 Where an entity holding radioactive sources returns any waste or used radioactive source to the production entity or the original exporter or delivers it for storage to an entity engaged in the centralized storage of radioactive wastes, it shall, within 20 days from the day of completion of the said activity, file a report on it with the department of ecology and environment of the people's government of the province, autonomous region or municipality directly under the Central Government where i......