Regulations on the Security and Protection of Radioisotope and Radioactive Ray Devices
Regulations on the Security and Protection of Radioisotope and Radioactive Ray Devices
Regulations on the Security and Protection of Radioisotope and Radioactive Ray Devices
Order of the State Council No. 449
September 14, 2005
Chapter I General Provisions
Article 1 In order to strengthen the supervision on the security and protection of the radioisotope and the radioactive ray devices, promote the security application of the radioisotope and radioactive rays, assure human health, and protect the environment, these Regulations are hereby formulated.
Article 2 These Regulations shall apply to the manufacture, sale and use of the radioisotope or the radioactive ray devices, and the transfer and import of the radioisotope within the territory of the People's Republic of China.
The radioisotope as mentioned in these Regulations means the radioactive source and unsealed radioactive substance.
Article 3 The competent environment protection department under the State Council shall be responsible for uniform supervision over the security and protection of the radioisotope and the radioactive ray devices.
The public security organ and health department under the State Council shall be responsible for supervision over the security and protection of the radioisotope and the radioactive ray devices in accordance with the assignment of responsibilities and these Regulations.
The competent environment protection departments, and other relevant departments at or above the county level shall be responsible for the supervision over the security and protection of the radioisotope and the radioactive ray devices within their respective administration areas in accordance with the assignment of responsibilities and these Regulations.
Article 4 The state carries out the administration on the radioactive source and the radioactive ray devices by classifying them. According to the potential hazard of the radioactive source and the radioactive ray devices to the human heath and environment, the radioactive source is classified into classes I, II, III, IV, and V, and the detailed classifying measures shall be formulated by the competent environment protection department under the State Council; and the radioactive ray devices are classified into classes I, II, and III, and the detailed classifying measures shall be formulated by the competent environment protection department under the State Council through consulting the competent heath department under the State Council.
Chapter II Approval and Filing
Article 5 Any unit which manufactures, sells or uses the radioisotope or the radioactive ray devices shall obtain the license in accordance with the provisions of this Chapter.
Article 6 The issuance of the licenses to the units that manufacture the radioisotope, sell and use class I radioactive source, and sell and use class I radioactive ray devices, shall be examined and approved by the competent environment protection department under the State Council.
The issuance of licenses to units other than those mentioned in the preceding Paragraph shall be examined and approved by the competent environment departments under the people's government of various provinces, autonomous regions or municipalities directly under the Central Government.
The competent environment protection department under the State Council shall, prior to the issuance of the license to the unit manufacturing the radioisotope, deliver the copies of application materials to relevant industrial administrative departments for opinions.
The competent environment protection department shall notify the public security organ and competent heath department at the same level of the examination, approval and issuance of the license.
Article 7 A unit applying for the license for the manufacture, sale and use of the radioisotope or the radioactive ray devices shall meet the conditions below:
1. Being staffed with the professional and technical personnel who are appropriate for the scale of the activities of manufacture, sale and use, have corresponding professional and protection knowledge, and meet the heath conditions;
2. Being equipped with the place, facilities and equipment which meet the environmental protection standards, occupational health standards and safety protection requirements of the state;
3. Having set up special security and protection management department, or being staffed with part-time or full-time security and protection management personnel, and being equipped with necessary protecting appliance and monitoring equipment;
4. Having established sound security and protection management rules and regulations and emergency measures against radiation accidents; and
5. Where the radioactive exhaust gas, waste liquor or solid waste is produced, having the ability or having made the feasible plan to ensure that such exhaust gas, waste liquor and solid waste could be discharged according to the standards.
Article 8 The unit which manufactures, sells or uses the radioisotope or the radioactive ray devices shall, in advance, apply to the competent environment protection department with the authority of examination and approval and submit the materials proving that it has met the conditions as provided in Article 7 hereof.
The medical and health organization which uses the radioisotope and the radioactive ray devices for making a diagnosis and giving treatment shall additionally obtain the license of the technique of making a diagnosis and giving treatment with the radioactive source and medical radiation institution.
Article 9 The competent environment protection department shall, within 20 working days as of the date on which the application is accepted, issue the license to the applicant which meets relevant conditions and make a public announcement; where the applicant fails to meet any of the conditions, give a written reply with explanations to the applicant.
Article 10 The contents of a license shall consist of:
1. Name, address and legal representative of the unit;
2. Type and scope of the activities that it engages in;
3. Term of validity; and
4. Date of issuance and license number.
Article 11 Where a unit holding the license modifies its name, address or legal representative, it shall, within 20 days as of the date of modification registration, apply to the original license-issuing authority for handling the formalities for modifying the license.
Article 12 Under either of the following circumstances, the unit holding the license shall reapply for the license according to the original applying procedures:
1. The type or scope of the activities that the unit engages in is changed; or
2. The facilities or places for the manufacture, sale or use of the radioisotope or the radioactive ray devices are built, rebuilt or extended.
Article 13 The valid period of the license is 5 years. Where the license needs renewing upon the expiration of its valid period, the unit holding the license shall apply to the original issuing authority for renewing it 30 days prior to the expiration of such license. The original issuing authority shall complete the examination prior to the expiration of the valid period of such license after accepting such application, and approve the renewal of such license if relevant conditions are met; or give a reply with explanations to the applicant if any of relevant conditions fails to be met.
Article 14 Where the unit holding the license terminates all or part of the activities of manufacture, sale or use of the radioisotope or the radioactive ray devices, it shall apply to the original issuing authority for partly modifying or canceling the license, and the original issuing authority shall modify or cancel the license after relevant conditions are met through the examination by the original issuing authority.
Article 15 The activities of manufacture, sale and use of the radioisotope or the radioactive ray devices which are carried out without the license or do not conform to the type or scope as specified are prohibited.
The counterfeiting, falsification or transfer of the license shall also be prohibited.
Article 16 The competent foreign trade department under the State Council shall, in conjunction with the competent environment protection department under the State Council, the General Administration of Customs, the General Administration of Quality Supervision, Inspection and Quarantine, and the industrial administrative department in charge of the units manufacturing the radioisotope, make and publish the catalogue of the radioisotope subject to import and export restriction and the catalogue of the radioisotope subject to import and export prohibition.
The license for the import of the radioisotope listed in the catalogue of the radioisotope subject to import and export restriction shall be issued in accordance with relevant provisions of the state on foreign trade by the competent foreign trade department under the State Council after being approved by the competent environment protection department under the State Council through examination. Where the radioisotope other than that listed in the catalogue of the radioisotope subject to import and export restriction and the catalogue of the radioisotope subject to import and export prohibition is imported, the import formalities shall be handled in accordance with relevant provisions of the state on foreign trade.
Article 17 Where the import of the radioisotope listed in the catalogue of the radioisotope subject to import and export prohibition is applied for, the following conditions shall be met:
1. The importing unit has obtained the license for the activities that it engages in;
2. The importing unit has made the plan to treat the radioisotope to be imported after its use term expires. Where the radioisotope to be imported is of class I, II or III, the importing unit shall also obtain the recovery commitment document issued by the exporter;
3. Definite marks and necessary instruction files shall be provided for the imported radioactive source. The marks for the radioactive source of class I, II and III shall be engraved on the body or sealed housing of such radioactive source, and those for the radioactive source of class IV and V shall be recorded in corresponding documents; and
4. Where the imported radioisotope is sold to any other unit for use, the selling unit shall sign a written agreement with the using unit and obtain the copy of license of the using unit for such use.
Article 18 The unit which is going to import the radioisotope listed in the catalogue of the radioisotope subject to import and export prohibition shall apply for the import to the competent environment protection department under the State Council and submit testimonial materials as provided in Article 17 hereof.
The competent environment protection department shall, within 10 working days as of the date on which the application is accepted, approve the application if relevant conditions are met; where the applicant fails to meet any conditions, give a written reply with explanations to the applicant.
The customs shall examine the license for import of the radioisotope and handle the import formalities according to the import license.
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