Import, transfer of radioisotopes, radioisotope field tracer tests, shall be submitted for approval in accordance with the provisions of these Measures.
The export of radioisotopes shall go through the relevant procedures in accordance with the provisions of these Measures.
Units using radioisotopes that transfer radioisotopes for use to other provinces, autonomous regions or municipalities directly under the Central Government shall file a report in accordance with the provisions of these Measures.
The radioisotopes referred to in these measures include radioactive sources and non-sealed radioactive substances. Article according to the radioactive sources and radiation devices on human health and the environment of the potential hazards, from high to low, the radioactive sources are divided into Ⅰ, Ⅱ, Ⅲ, Ⅳ, Ⅴ, the radiation device is divided into Ⅰ, Ⅱ, Ⅲ. Article IV production of radioisotopes, the sale and use of Class Ⅰ radioactive sources, sales and use of Class Ⅰ radiation device radiation work unit license, the State Council environmental protection department for approval and issuance.
Licenses for radiation work units other than those provided for in the preceding paragraph shall be approved and issued by the competent department for environmental protection of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government (hereinafter referred to as the "competent department for environmental protection at the provincial level").
A radiation work unit that produces, sells or uses multiple types of radioactive sources, radiation devices or unsealed radioactive substances is required to apply for only one license.
If a radiation work unit needs to apply for a license from the competent environmental protection department under the State Council and the competent provincial environmental protection department at the same time, its license shall be approved and issued by the competent environmental protection department under the State Council.
The competent department of environmental protection shall notify the public security department and the competent health department at the same level of the approval of the issuance of licenses. Article 5 The competent department of environmental protection of the people's government at or above the provincial level may entrust the competent department of environmental protection of the people's government at the next level for approval and issuance of licenses. Article 6 The competent department of environmental protection under the State Council shall be responsible for approving the import of radioisotopes listed in the catalog of restricted imports and exports.
The competent department for environmental protection under the State Council shall, in accordance with the relevant laws of China and the provisions of the international treaties and agreements concluded or participated in, handle the relevant formalities for the export of radioisotopes included in the catalog of restricted imports and exports.
The competent department for environmental protection at the provincial level is responsible for the approval or filing of the following activities:
(1) transfer of radioisotopes;
(2) transfer of radioisotopes for use in foreign provinces, autonomous regions and municipalities directly under the central government;
(3) radioisotope field tracing tests; however, radioisotope field tracing tests which may cause environmental impacts across provincial boundaries Chapter II Application and Issuance of License Article 7 Before applying for a license, a radiation work unit shall organize the preparation or filling in of an environmental impact assessment document and report it to the competent department for environmental protection for approval in accordance with the procedures prescribed by the State.
Environmental impact assessment documents in the environmental impact report or environmental impact report form, shall be prepared by an organization with the appropriate environmental impact assessment qualifications. Article 8 According to the safety and protection requirements of radioisotopes and radiation devices and their degree of impact on the environment, the environmental impact assessment documents are categorized and managed.
The activities of transferring radioisotopes and radiation devices are not required to prepare environmental impact assessment documents. Article 9 The radiation work unit applying for a license to engage in the following activities shall organize the preparation of an environmental impact report:
(1) production of radioisotopes (except for the preparation of radiopharmaceuticals for PET);
(2) use of Class I radioactive sources (except for medical use);
(3) the sale (including the construction of), the use of Class I radiation devices . Article 10 The application for a license to the radiation work unit engaged in the following activities, shall organize the preparation of environmental impact report form:
(a) the preparation of PET radiopharmaceuticals;
(b) the sale of Class Ⅰ, Ⅱ, Ⅲ, Ⅳ type of radioactive sources;
(c) medical use of Class Ⅰ type of radioactive sources;
(d) the use of Ⅱ, Ⅲ, Ⅳ type of radioactive sources;
(d) the use of Ⅱ, Ⅲ, Ⅳ type of radioactive sources;
(e) the use of radioactive sources;
(f) the use of radioactive sources (D) the use of Class II, Class III, Class IV radioactive sources;
(E) the production, sale and use of Class II radiation devices. Article XI of the radiation work unit to apply for a license to engage in the following activities, shall fill in the environmental impact registration form:
(a) the sale and use of Class V radioactive sources;
(b) the production, sale and use of Class III radiation device. Article XII of the radiation work unit organization to prepare or fill in the environmental impact assessment documents, shall be evaluated in accordance with its planning and design of radioisotopes and radiation devices, production, sales and use of scale.
The environmental impact assessment documents referred to in the preceding paragraph, in addition to the preparation or filling in the requirements of the relevant state environmental impact assessment, shall also include an evaluation of the technical ability of the radiation work unit to engage in the corresponding radiation activities, radiation safety and protection measures. Article 13 A unit that produces radioisotopes and applies for a license shall have the following conditions:
(1) It has a specialized radiation safety and environmental protection management organization.
(2) There shall be not less than five technicians specialized in nuclear physics, radiochemistry, nuclear medicine and radiation protection, of which not less than one has a senior title.
Units producing radioisotopes with a half-life of more than 60 days shall have not less than 30 professional and technical personnel referred to in the preceding subparagraph, of whom not less than 6 shall have senior titles.
(C) personnel engaged in radiation work must pass the training and examination of specialized knowledge of radiation safety and protection as well as relevant laws and regulations, of which key positions in radiation safety should be held by registered nuclear safety engineers.
(4) There are radioisotope production sites, production facilities, temporary storage or temporary storage equipment that are compatible with the designed scale of production and meet the requirements of radiation safety and protection and physical defense, and have the ownership of the production sites and production facilities.
(v) has the transportation and storage of radioisotopes packaging containers that meet the requirements of the relevant state regulations.
(F) has a means of transportation that meets the national requirements for the transportation of radioisotopes, and is equipped with a full-time driver with more than five years of driving experience.
(vii) Equipped with protective gear and monitoring instruments appropriate to the type and level of radiation, including personal dosimetry alarms, fixed and portable radiation monitoring, surface contamination monitoring, effluent monitoring and other equipment.
(viii) the establishment of sound operating procedures, job responsibilities, radiation protection system, safety and security system, equipment repair and maintenance system, personnel training system, account management system and monitoring program.
(ix) the establishment of emergency response agencies, the development of emergency response plan and emergency personnel training exercises system, the necessary emergency equipment and materials preparedness, and the design and production scale of emergency response capacity to deal with accidents.
(j) have to ensure that radioactive waste gas, waste liquids, solid waste discharge capacity or feasible treatment programs.