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 environmental protection of the State Council.
In addition to the license issued by the competent department of environmental protection in the State Council, the licenses of other radiation work units shall be approved and issued by the competent department of environmental protection 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 need to apply for licenses to the competent department of environmental protection in the State Council and the competent department of environmental protection at the provincial level respectively, which shall be approved and issued by the competent department of environmental protection in the State Council.
The competent department of environmental protection 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 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 lower level to examine and approve the issuance of licenses. Article 6 The competent department of environmental protection of the State Council shall be responsible for examining and approving the import of radioisotopes listed in the restricted import and export catalogue.
The competent department of environmental protection of the State Council shall, in accordance with the relevant laws of China and the provisions of international treaties and agreements concluded or acceded to, go through the relevant procedures for the export of radioisotopes listed in the restricted import and export catalogue.
The provincial environmental protection department is responsible for the 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 environmental protection of the State Council. Chapter II Application and Issuance of Permit Article 7 Before applying for a permit, a radiation work unit shall organize the preparation or completion of an environmental impact assessment document and submit it to the competent department of environmental protection for examination and approval in accordance with the procedures prescribed by the state.
The environmental impact report or environmental impact report form in the environmental impact assessment document shall be compiled by an institution with corresponding environmental impact assessment qualifications. 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 the first type of radiation devices. 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.