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 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 in addition to the medical use of Class I radioactive sources, preparation of positron emission computed tomography with radiopharmaceuticals for their own use, the production of radioisotopes, the sale and use of Class I radioactive sources, sales and use of Class I radiation device radiation work unit licenses issued by the State Council ecological and environmental authorities for approval.
Except for the licenses approved and issued by the competent ecological and environmental department of the State Council, the licenses for other radiation work units shall be approved and issued by the competent ecological and environmental department of the people's governments of provinces, autonomous regions and municipalities directly under the central government.
A radiation work unit that produces, sells, or uses more than one type of radioactive source, radiation device, or unsealed radioactive material is required to apply for only one license.
If a radiation work unit needs to apply for a license from the ecological and environmental authorities under the State Council and the provincial ecological and environmental authorities at the same time, its license shall be approved and issued by the ecological and environmental authorities under the State Council.
The competent ecological environment department shall notify the public security department at the same level, the competent health department for approval of the 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 level to approve the issuance of licenses. Article 6 The competent department for ecology and environment under the State Council shall be responsible for approving the import of radioisotopes listed in the restricted import and export catalog.
The competent ecological and environmental department 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 listed in the catalog of restricted imports and exports.
The competent ecological and environmental authorities at the provincial level are 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 experiments; however, radioisotope field tracing experiments that are likely to result in an impact on the environment across the provincial boundaries Chapter II Application and Issuance of License Article 7 Before applying for a license, the radiation work unit shall organize the preparation or fill in the environmental impact assessment documents, and in accordance with the state procedures for approval by the competent department of ecological environment. 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 shall be 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 radiation work unit applying for a license to engage in the following activities shall organize the preparation of the environmental impact report form:
(1) preparation of radiopharmaceuticals for PET;
(2) sale of radioactive sources of Class I, Class II, Class III;
(3) medical use of radioactive sources of Class I;
(4) the use of radioactive sources of Class II, Class III;
(e) the production, sale and use of Class II radiation devices. Article XI apply for a license to receive radiation work units engaged in the following activities, shall fill in the environmental impact registration form:
(a) the sale, use of Class Ⅳ, 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, should be in accordance with its planning and design of radioisotopes and radiation devices, production, sales and use of scale evaluation.
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) A special radiation safety and environmental protection management organization.
(2) There shall be no less than five technicians specializing in nuclear physics, radiochemistry, nuclear medicine and radiation protection, of which no 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) have packaging containers for the transportation and storage of radioisotopes that meet the requirements of the relevant state regulations
(vi) have means of transportation that meet the state requirements for the transportation of radioisotopes, and are equipped with full-time drivers 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.