The import, transfer and on-site tracing test of radioactive isotopes shall be submitted for approval in accordance with the provisions of these Measures.
The export of radioisotopes shall go through relevant procedures in accordance with the provisions of these Measures.
Radioisotope users who transfer radioisotopes to other provinces, autonomous regions and municipalities directly under the Central Government shall file records in accordance with the provisions of these Measures.
Radioisotopes mentioned in these Measures include radioactive sources and unsealed radioactive substances. Article 3 According to the potential hazards of radioactive sources and radiation devices to human health and the environment, from high to low, radioactive sources are classified into Class I, Class II, Class III, Class IV and Class V, and radiation devices are classified into Class I, Class II and Class III. Article 4 Except for units that use Class I radioactive sources for medical treatment and prepare radiopharmaceuticals for positron emission computed tomography, the licenses of radiation work units that produce radioisotopes, sell and use Class I radioactive sources and sell and use Class I radiation devices shall be examined and approved by the competent department of ecology and environment of the State Council.
In addition to the license issued by the competent department of ecological environment in the State Council, the licenses of other radiation work units shall be approved and issued by the competent department of ecological environment of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.
Radiological work units that produce, sell or use all kinds of radioactive sources, radiation devices or unsealed radioactive substances only need to apply for licenses.
Radiation work units shall apply to the competent department of ecological environment in the State Council and the competent department of ecological environment at the provincial level respectively, and their licenses shall be approved and issued by the competent department of ecological environment in the State Council.
The competent department of ecological environment shall notify the public security department and the competent department of health at the same level of the approval and issuance of licenses. Article 5 The competent department of ecological environment of the people's government at or above the provincial level may entrust the competent department of ecological environment of the people's government at the next lower level to examine and approve the issuance of licenses. Article 6 The competent department of ecological environment of the State Council shall be responsible for examining and approving the import of radioactive isotopes listed in the restricted import and export catalogue.
The competent department of ecological environment of the State Council shall, according to the relevant laws of China and the provisions of international treaties and agreements concluded or acceded to, handle the relevant procedures for the export of radioisotopes listed in the restricted import and export catalogue.
The provincial department in charge of ecological environment is responsible for the examination and approval or filing of the following activities:
(1) Transfer of radioisotopes;
(2) Transporting radioactive isotopes to other provinces, autonomous regions and municipalities directly under the Central Government for use;
(3) Radioisotope field tracing test; However, the on-site tracer test of radioisotopes that may cause inter-provincial environmental impact shall be examined and approved by the competent department of ecological environment of the State Council. Chapter II Application and Issuance of Permits Article 7 Before applying for a permit, a radiation work unit shall organize the preparation or completion of environmental impact assessment documents and submit them to the competent department of ecological environment for examination and approval according to the procedures prescribed by the state. Eighth according to the safety and protection requirements of radioisotopes and radiation devices and their impact on the environment, the environmental impact assessment documents shall be classified and managed.
The activities of transferring radioisotopes and radiation devices do not require the preparation of environmental impact assessment documents. Article 9 Where a radiation work unit applying for permission engages in the following activities, it shall organize the preparation of an environmental impact report:
(1) producing radioisotopes (except for preparing radiopharmaceuticals for PET);
(2) Using radioactive sources of Category I (except for medical use);
(3) selling (including building) or using ray devices of Class I.. Article 10 Where a radiation work unit applying for permission engages in the following activities, it shall organize the preparation of an environmental impact report:
(1) Preparation of radiopharmaceuticals for PET;
(2) Selling radioactive sources of Category I, II and III;
(3) Medical use of radioactive sources of Category I;
(4) Using Class II and Class III radioactive sources;
(five) the production, sale and use of Class II radiation devices. Eleventh radiation work units that apply for permission to engage in the following activities shall fill in the environmental impact registration form:
(1) Selling or using radioactive sources of Category IV and Category V;
(two) the production, sale and use of Class III radiation devices. Twelfth radiation work units to organize the preparation or declaration of environmental impact assessment documents, should be based on the planning and design of the production, sale and use of radioisotopes and radiation devices to evaluate the scale.
The environmental impact assessment documents mentioned in the preceding paragraph shall include the evaluation of the technical ability, radiation safety and protective measures of the radiation work units engaged in corresponding radiation activities, in addition to being compiled or filled in according to the requirements of the state on environmental impact assessment. Article 13 When applying for a license, a unit that produces radioisotopes shall meet the following conditions.
(a) there is a special radiation safety and environmental protection management institution.
(2) There shall be no less than 5 technicians specialized in nuclear physics, radiochemistry, nuclear medicine and radiation protection, among whom there shall be no less than 1 person with senior titles.
Units that produce radioisotopes with a half-life of more than 60 days shall have not less than 30 professional and technical personnel mentioned in the preceding paragraph, including not less than 6 with senior titles.
(3) Personnel engaged in radiation work must undergo training and examination in radiation safety and protection professional knowledge and relevant laws and regulations, and key positions in radiation safety should be held by registered nuclear safety engineers.
(4) Having radioactive isotope production sites, production facilities, temporary storage warehouses or temporary storage equipment that are suitable for the designed production scale and meet the requirements of radiation safety and protection and physical security, and having the ownership of the production sites and facilities.
(5) There are packaging containers that meet the requirements of the state on the transportation and storage of radioactive isotopes.
(6) Having means of transport that meet the national requirements for the transport of radioisotopes, and being equipped with full-time drivers who have been driving for more than 5 years.
(seven) equipped with protective equipment and monitoring instruments suitable for radiation types and radiation levels, including personal dose measurement alarm, fixed and portable radiation monitoring, non-point source pollution monitoring, effluent monitoring and other equipment.
(eight) to establish and improve the operating rules, job responsibilities, radiation protection system, safety system, equipment maintenance system, personnel training system, accounting management system and monitoring scheme.
(nine) the establishment of accident emergency agencies, emergency plans and emergency personnel training and drills system, with the necessary emergency equipment and material preparation, with the ability to deal with accidents that are suitable for the design and production scale.
(10) Having the treatment capacity or feasible treatment scheme to ensure the discharge of radioactive waste gas, waste liquid and solid waste up to the standard.