Decree of the State Council of the People's Republic of China

No. 449

The Regulations on the Safety and Protection of Radioisotopes and Radioactive Devices have been adopted by the 104th Standing Meeting of the State Council on August 31, 2005, and are hereby promulgated for implementation as of December 1, 2005.

General Li Wen Jiabao

14 September 2005

Regulations on the Safety and Protection of Radioisotopes and Radiation Devices

Chapter I General Provisions

Article 1 These Regulations are formulated in order to strengthen the supervision and management of the safety and protection of radioactive isotopes and radiation devices, promote the safe application of radioactive isotopes and radiation devices, safeguard human health and protect the environment.

Article 2 These Regulations shall be observed in the production, sale and use of radioisotopes and radiological devices within the territory of the People's Republic of China, as well as in the transfer, import and export of radioisotopes.

Radioisotopes referred to in these Regulations include radioactive sources and non-sealed radioactive substances.

Article 3 The competent environmental protection department under the State Council shall exercise unified supervision and management over the safety and protection of radioactive isotopes and radiation devices throughout the country.  Departments of public security and health under the State Council shall, in accordance with the division of duties and the provisions of these Regulations, supervise and administer the safety and protection of radioactive isotopes and radiation devices. The competent environmental protection authorities of the local people's governments at or above the county level and other relevant departments shall, in accordance with the division of duties and the provisions of these Regulations, supervise and administer the safety and protection of radioactive isotopes and radiation devices within their respective administrative areas.

Article 4 The State exercises classified management over radioactive sources and radiation devices. According to the potential harmfulness of radiation sources and radiation devices to human health and environment, radiation sources are classified into categories I, II, III, IV and V from high to low. Specific classification methods are formulated by the competent environmental protection authorities under the State Council; radiation devices are classified into categories I, II and III, and specific classification methods are classified by the State Council. The competent department of environmental protection shall formulate it in consultation with the competent department of health under the State Council.

Chapter II Licensing and Recording

Article 5 Units that produce, sell and use radioisotopes and radiological devices shall obtain licenses in accordance with the provisions of this Chapter.

Article 6 The licenses of units that produce radioisotopes, sell and use category I radioactive sources, sell and use category I radiological devices shall be examined and approved by the competent environmental protection department under the State Council. The permits of units other than those specified in the preceding paragraph shall be examined and approved by the competent environmental protection authorities of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government. Before issuing a license to a unit producing radioisotopes, the competent environmental protection department under the State Council shall print the application materials to its competent industry department for comments. The competent environmental protection department shall inform the public security department and the competent health department at the same level about the examination, approval and issuance of licenses.

Article 7 Units producing, selling and using radioisotopes and radiological devices shall meet the following requirements when applying for a license:

(1) All professionals and technicians with relevant professional knowledge, protection knowledge and health conditions who are suitable for the scale of production, sale and use activities engaged in;

(2) Having places, facilities and equipment that meet the national environmental protection standards, occupational health standards and safety protection requirements;

(3) There are special safety and protection management organizations or full-time and part-time safety and protection management personnel, and equipped with necessary protective equipment and monitoring instruments;

(4) To have sound safety and protection management rules and regulations and emergency measures for radiation accidents;

(5) Those who produce radioactive waste gases, liquids or solid wastes shall have the disposal capacity or feasible disposal scheme to ensure that radioactive waste gases, liquids and solid wastes meet the discharge standards.

Article 8 Units that produce, sell and use radioisotopes and radiological devices shall apply for permission in advance to the competent environmental protection authorities with the power of examination and approval, and submit certification materials that meet the requirements specified in Article 7 of these Regulations. Medical and health institutions that use radioisotopes and radiological devices for radiological diagnosis and treatment shall also obtain permission from radiological source diagnosis and treatment technologies and medical radiation institutions.

Article 9 The competent environmental protection authority shall complete the examination within 20 working days from the date of accepting the application. If it meets the requirements, it shall issue a license and make a public announcement; if it fails to meet the requirements, it shall notify the applicant in writing and explain the reasons.

Article 10 The license includes the following main contents:

(1) The name, address and legal representative of the unit;

(2) The types and scope of activities undertaken;

(3) The period of validity;

(4) Issuance date and certificate number.

Article 11 If a licensed entity changes its name, address or legal representative, it shall, within 20 days from the date of registration, apply to the original license issuing authority for the change of license.

Article 12 In any of the following circumstances, the Licensee shall reapply for a license in accordance with the original application procedure:

(1) Changing the type or scope of activities undertaken;

(2) Building or rebuilding or expanding facilities or places for production, sale or use.

Article 13 The validity period of the license is five years. If the validity period expires and needs to be extended, the Licensee shall apply to the original license issuing authority for extension 30 days before the expiration of the validity period of the license. The original license issuing organ shall complete the examination before the expiration of the validity period of the license from the date of accepting the application for renewal. If it meets the requirements, it shall renew it; if it fails to meet the requirements, it shall notify the applicant in writing and explain the reasons.

Article 14 Where the licensee partially terminates or completely terminates the production, sale or use of radioactive isotopes and radiological devices, it shall apply to the original licensing authority for partial alteration or cancellation of the license, which shall be altered or cancelled after verification by the original licensing authority.

Article 15 It is forbidden to engage in the production, sale and use of radioisotopes and radiological devices without a license or in accordance with the types and scope specified in the license. Forgery, alteration and transfer of licenses are prohibited.

Article 16 The competent foreign trade department of the State Council, in conjunction with the competent environmental protection department of the State Council, the General Administration of Customs, the quality supervision, inspection and Quarantine Department of the State Council and the competent administrative departments of the units producing radioactive isotopes, shall formulate and publish catalogues of radioactive isotopes for import and export restrictions and catalogues of prohibited radioactive isotopes for import and The import of radioactive isotopes listed in the restricted import and export catalogue shall be examined and approved by the competent environmental protection department under the State Council, and the competent foreign trade department under the State Council shall issue an import license in accordance with the relevant provisions of the State on foreign trade. Radioactive isotopes outside the import and export restricted catalogues and prohibited Catalogues shall be imported in accordance with the relevant provisions of the State on foreign trade.

Article 17 An application for importation of radioactive isotopes listed in the catalogue of restricted import and export shall meet the following requirements:

(1) The importing entity has obtained a license in conformity with the activities it engages in;

(2) The importing unit shall have a disposal plan after the expiration of the service life of the imported radioisotopes. Where the imported radioactive sources of Class I, II and III are imported, the original exporter shall have a commitment document for recovery.

(3) The imported radioactive sources shall have clear labels and necessary explanatory documents, in which the labels of Class I, Class II and Class III radioactive sources shall be engraved on the body of the radioactive source or on the sealed enclosure, and the labels of Class IV and V radioactive sources shall be recorded in the corresponding explanatory documents;

(4) If imported radioisotopes are sold to other units for use, they shall also have a written agreement signed with the user and a copy of the license obtained by the user.

Article 18 Units that import radioactive isotopes listed in the catalogue of import and export restrictions shall apply to the competent environmental protection department under the State Council for import and submit certification materials that meet the requirements of Article 17 of these Regulations.

The competent department of environmental protection under the State Council shall complete the examination within 10 working days from the date of accepting the application, and if it meets the requirements, it shall approve it; if it fails to meet the requirements, it shall notify the applicant in writing and explain the reasons. The customs shall go through the relevant import formalities with the import license of radioactive isotopes. If the imported radioactive isotope packaging materials need to be quarantined according to law, they shall be implemented in accordance with the relevant national quarantine laws and regulations. For imported radioactive sources, the competent environmental protection department under the State Council shall also determine the source codes corresponding to their labels at the same time.

Article 19 An application for the transfer of radioactive isotopes shall meet the following requirements:

(1) A transfer or transfer entity holds a license in conformity with the activities it engages in;

(2) The treatment plan after the expiration of the service life of the radioactive isotopes transferred into the unit;

(3) The two parties to the assignment have signed a written agreement on the assignment.

Article 20 For the transfer of radioactive isotopes, the transferred unit shall apply to the competent environmental protection authorities of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government where it is located, and submit certification materials that meet the requirements of Article 19 of these Regulations. The competent environmental protection authorities of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall complete the examination within 15 working days from the date of accepting the application. If the application meets the requirements, it shall be approved. If the application does not meet the requirements, the applicant shall be notified in writing and the reasons given.

Article 21 Units transferring or transferring radioactive isotopes shall, within 20 days from the date of completion of the transfer activities, file their records with the competent environmental protection authorities of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government where they are located.

Article 22 Units that produce radioisotopes shall establish accounts of radioisotope products and uniformly code the radioactive sources produced in accordance with the coding rules formulated by the competent environmental protection department under the State Council. The account of radioisotope products and the list of codes of radioactive sources shall be submitted to the competent department of environmental protection under the State Council for the record. Radioactive sources produced should have clear labels and necessary documentation. The labels of Class I, Class II and Class III radioactive sources shall be engraved on the body of the radioactive source or on the sealed enclosure, and the labels of Class IV and V radioactive sources shall be recorded in the corresponding deive documents. The competent department of environmental protection under the State Council is responsible for establishing the information management system for radioisotope records and sharing information with relevant departments.  Radioisotopes and uncoded radioactive sources not included in the product ledger shall not be manufactured or sold.

Article 23 Units that hold radioactive sources shall return the spent radioactive sources to the production units, to the original exporters or to the centralized storage units of radioactive waste for storage, and shall file with the competent environmental protection authorities of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government where the activities are completed within 20 days.

Article 24 Radioisotopes produced and imported before the implementation of these Regulations shall be registered by the radioisotope holder within six months from the date of implementation of these Regulations to the competent environmental protection authorities of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government where they are located. The environmental protection owners of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government The regulatory authorities shall unify the coding of radioactive sources.

Article 25 Units using radioisotopes that need to transfer radioisotopes to other provinces, autonomous regions and municipalities directly under the Central Government for use shall, with a copy of the license, file with the competent environmental protection authorities of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government for the record, and accept the supervision and management of the competent local environmental protection authorities.

Article 26 For the export of radioactive isotopes listed in the catalogue of restricted import and export, the importer shall provide proof materials that the importer may legally hold radioactive isotopes, and the competent environmental protection department under the State Council shall go through relevant formalities in accordance with relevant laws and the provisions of international treaties and agreements concluded or acceded to by China. Export of radioactive isotopes shall comply with the relevant provisions of the State on foreign trade.

Chapter III Safety and Protection

Article 27 Units that produce, sell and use radioisotopes and radiological devices shall be responsible for the safety and protection of their radioisotopes and radiological devices, and shall be liable for the radioactive hazards caused by them according to law. The competent authorities of the units producing radioisotopes shall strengthen the management of the safety and protection work of the production units, and regularly supervise and inspect their implementation of laws, regulations and national standards.

Article 28 Units that produce, sell and use radioisotopes and radiological devices shall conduct safety and protection knowledge education and training for staff directly engaged in production, marketing and use activities, and conduct assessment; those who fail to pass the assessment shall not be allowed to take up their posts. Key positions for radiation safety shall be held by registered nuclear safety engineers. The directory of key positions for radiation safety shall be formulated and published by the competent environmental protection department under the State Council in consultation with the relevant departments under the State Council.

Article 29 Units that produce, sell and use radioisotopes and radiological devices shall, in strict accordance with the provisions of the State on individual dose monitoring and health management, conduct individual dose monitoring and occupational health examination for staff directly engaged in production, marketing and use activities, and establish individual dose files and posts. Industry health surveillance files.

Article 30 Units that produce, sell and use radioisotopes and radiological devices shall conduct annual assessments of the safety and protection of radioisotopes and radiological devices in their units. If a potential safety hazard is found, it shall be rectified immediately.

Article 31 If a unit that produces, sells or uses radioisotopes or radiological devices needs to terminate, it shall clean up and register its radioisotopes and radioactive wastes in advance, and properly handle them without leaving any potential safety hazards. If any unit that produces, sells or uses radioisotopes or radiological devices changes, the unit that has changed shall bear the responsibility for handling the changes. Where the parties have agreed otherwise before the change, the agreement shall be followed; however, the parties'obligation to deal with the matter shall not be exempted from the agreement. Units that have terminated the production, sale and use of radioactive isotopes and radiation devices before the implementation of these Regulations shall put forward treatment plans by the competent environmental protection authorities of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government where they are located for their unsafe disposal of waste radioactive sources and radioactive wastes, and handle them in a timely manner. The funds required shall be borne by the people's governments at or above the provincial level.

Article 32 Units producing and importing radioactive sources that sell Category I, II and III radioactive sources for use by other units shall sign agreements on the return of spent radioactive sources by units using radioactive sources; units using radioactive sources shall return the spent radioactive sources to production units or return them in accordance with the provisions of the agreement on the return of spent radioactive sources. Return to the original exporter. If it is really impossible to return it to the production unit or to the original exporter, it shall be sent to the centralized storage unit of radioactive waste with corresponding qualifications for storage. Units using radioactive sources shall, in accordance with the regulations of the competent environmental protection department under the State Council, pack and prepare waste radioactive sources of Class IV and V and send them to centralized storage units with corresponding qualifications for storage.

Article 33. Sites where radioactive sources of Class I, II and III are used and where radioactive isotopes are produced, as well as radioactive contamination devices after termination of operation, shall be decommissioned according to law.

Article 34 Where radioactive isotopes and radiological devices are produced, sold, used or stored, obvious radioactive signs shall be set up in accordance with the relevant provisions of the State, and safety and protective facilities, as well as necessary safety interlocking and alarm devices shall be set up at the entrance according to the requirements of the relevant safety and protection standards of the State. Set or work signal. The place for production, commissioning and use of radiographic devices shall have safety measures to prevent misoperation and accidental exposure of workers and the public.

Packaging containers for radioactive isotopes, equipment containing radioactive isotopes and radiation devices shall be provided with obvious radioactive labels and warning instructions in Chinese; if radioactive labels can be set on radioactive sources, they shall be set up together. Tools for transporting radioisotopes and radiological devices containing radioactive sources shall set up obvious radiological markers or display dangerous signals in accordance with the relevant provisions of the State.

Article 35 Radioisotopes shall be stored separately, not together with inflammable, explosive or corrosive articles, and special persons shall be designated to take charge of the storage. When storing, receiving, using and returning radioactive isotopes, they shall be registered and inspected so as to keep the accounts in line.  Safety measures such as fire prevention, waterproof, theft-proof, loss-proof, damage-proof and radiation leakage-proof shall be taken for radioactive isotope storage sites. According to the potential hazards of radioactive sources, corresponding multi- protection and safety measures should be established, and movable radioactive sources should be periodically inventory to ensure that they are in a designated position and have reliable safety guarantee.

Article 36 Where radioactive isotopes and radiological devices are used outdoors or outdoors, safety protection zones shall be delineated in accordance with the requirements of national safety and protection standards, obvious radiological markers shall be set up, and special guards shall be set when necessary. Radioisotope tracer tests conducted in the field shall be approved by the competent environmental protection authorities of the people's governments at or above the provincial level in consultation with the relevant departments at the same level.

Article 37 Radiation protection equipment, equipment containing radioactive isotopes and radiation devices, products containing radioactive substances and electrical products accompanied by X-ray generation shall meet the requirements of radiation protection. Unqualified products shall not be manufactured or sold.

Article 38 Medical and health institutions that use radioisotopes and radiological devices for radiological diagnosis and treatment shall, in accordance with the relevant regulations of the competent health authorities under the State Council and the national standards, formulate quality assurance programs suitable for the diagnostic and therapeutic projects they are engaged in, abide by the quality assurance monitoring norms, and legitimate medical exposure. And the principle of radiation protection optimization, avoid all unnecessary radiation, and inform patients and patients in advance of the potential health effects of radiation.

Article 39 When recovering and smelting scrap ls, l smelters shall take necessary monitoring measures to prevent radioactive substances from melting into products. If problems are found in the monitoring, the competent environmental protection authorities of the people's governments at or above the municipal level with districts shall be notified in time.

Chapter IV Emergency Treatment of Radiation Accidents

Article 40 According to the nature, severity, controllability and scope of influence of radiation accidents, radiation accidents are classified into four grades, i.e. special major radiation accidents, major radiation accidents, major radiation accidents and general radiation accidents. Particularly serious radiation accidents refer to the consequences of large-scale serious radiation pollution caused by the loss, theft and out of control of type I and II radiation sources, or the acute death of more than three people (including three people) caused by the uncontrolled radioactive isotopes and radiation devices.

Major radiation accidents refer to the loss, theft or out of control of type I and II radiation sources, or the uncontrolled loss of radioisotopes and radiation devices, resulting in the acute death of less than two persons (including two persons) or the acute severe radiation diseases and local organ disabilities of more than 10 persons (including 10 persons). Larger radiation accidents refer to the loss, theft and out of control of type III radioactive sources, or the loss of control of radioisotopes and radiological devices, resulting in acute severe radiation sickness and local organ disability of less than 9 persons (including 9 persons). Generally speaking, radiation accidents refer to the loss, theft or out of control of type IV and V radiation sources, or the loss of control of radioisotopes and radiation devices, resulting in the exposure of personnel beyond the annual dose limit.

Article 41 The competent environmental protection department of the people's government at or above the county level shall, together with the public security, public health and financial departments at the same level, prepare emergency plans for radiation accidents and submit them to the people's government at the corresponding level for approval. The emergency plan for radiation accidents shall include the following contents:

(1) The division of responsibilities and emergency response agencies;

(2) Organization and training of emergency personnel and preparation of equipment, funds and materials for emergency and rescue;

(3) Radiation accident classification and emergency response measures;

(4) Investigation, reporting and handling procedures for radiation accidents. Units producing, selling and using radioisotopes and radiological devices shall formulate their own emergency plans and prepare for emergencies according to the risks of possible radiation accidents.

Article 42 When a radiation accident occurs, the units producing, selling and using radioactive isotopes and radiation devices shall immediately start their emergency plans, take emergency measures, and report immediately to the competent local environmental protection authorities, public security departments and health authorities. After receiving the report of radiation accident, the competent departments of environmental protection, public security and health shall immediately send people to the scene to conduct on-site investigation and take effective measures to control and eliminate the impact of the accident. At the same time, the information of radiation accident shall be reported to the competent departments of environmental protection of the people's governments at the corresponding level and the people's governments at higher levels and to the public. Security and health authorities. After receiving the report of radiation accidents, the local people's governments at or above the county level and their relevant departments shall timely report the information of radiation accidents to the people's governments at higher levels and their relevant departments in accordance with the provisions of the graded report of accidents. The people's governments of provinces, autonomous regions and municipalities directly under the Central Government and the relevant departments of the State Council shall report to the State Council within four hours after the occurrence of a particularly serious radiation accident or a major radiation accident; in special cases, the people's governments of the place where the accident occurred and their relevant departments may report directly to the State Council, and at the same time report to the people's affairs at higher levels. The government and its relevant departments. It is forbidden to postpone, conceal, falsely report or fail to report radiation accidents.

Article 43 When a radiation accident occurs or there is evidence that a radiation accident may occur, the competent environmental protection department of the people's government at or above the county level shall have the right to take the following temporary control measures:

(1) To order the suspension of operations leading to or possibly leading to radiation accidents;

(2) Organizing and controlling the accident scene.

Article 44 After a radiation accident occurs, the relevant people's governments at or above the county level shall, in accordance with the level of the radiation accident, initiate and organize the implementation of corresponding emergency plans. The competent departments of environmental protection, public security and health of the people's governments at or above the county level shall, in accordance with their respective responsibilities, do a good job in emergency response to radiation accidents:

(1) The competent environmental protection authorities are responsible for emergency response, investigation and disposal of radiation accidents and qualitative grading, and assist the public security departments in monitoring and recovering lost and stolen radioactive sources;

(2) The public security department shall be responsible for the investigation and recovery of lost or stolen radioactive sources on file;

(3) The competent health authorities are responsible for medical emergency response to radiation accidents. The competent departments of environmental protection, public security and health shall timely inform each other of the emergency response to radiation accidents, investigation and treatment, qualitative grading, case filing investigation and medical emergency. Departments designated by the State Council shall be responsible for the relevant international information communication according to the nature and level of radiation accidents determined by the competent environmental protection authorities.

Article 45 Units that have suffered from radiation accidents shall immediately send persons who may have been injured by radiation to hospitals designated by the local competent health authorities or hospitals that have the conditions to treat patients with radiation injuries for inspection and treatment, or request hospitals to send persons to the scene of the accident immediately and take remedial measures.

Chapter V Supervision and Inspection

Article 46 The competent environmental protection authorities of the people's governments at or above the county level and other relevant departments shall, in accordance with their respective duties, supervise and inspect the units that produce, sell and use radioisotopes and radiological devices. The inspected units shall cooperate, truthfully reflect the situation, provide necessary information, and shall not refuse or hinder it.

Article 47 The competent environmental protection authorities of the people's governments at or above the county level shall be equipped with radiation protection safety supervisors. Radiation protection safety supervisors are professionals who are engaged in radiation protection work, have knowledge of radiation protection safety and are recognized by the competent environmental protection authorities of the people's governments at or above the provincial level. Radiation protection safety supervisors shall receive regular professional training and assessment.

Article 48 The competent environmental protection department of the people's government at or above the county level shall be ordered to rectify within a time limit if it finds that units producing, selling and using radioactive isotopes and radiological devices do not meet the requirements of the original certification in the course of supervision and inspection. When supervising and inspecting according to law, supervisors and inspectors shall present their certificates and keep technical and business secrets for the units under inspection.

Article 49 Any unit or individual shall have the right to report violations of these Regulations to the competent environmental protection authorities and other relevant departments; if the competent environmental protection authorities and other relevant departments fail to perform their supervisory and administrative functions in accordance with the law, they shall have the right to report violations to the people's governments at the corresponding levels and the relevant departments of the people's governments at higher levels. The relevant people's governments, competent environmental protection departments and other relevant departments that have received the reports shall verify and deal with the reports in a timely manner.

Chapter VI Legal Liability

Article 50 If, in violation of the provisions of these Regulations, the competent environmental protection department of the people's government at or above the county level commits one of the following acts, administrative sanctions shall be imposed on the persons directly in charge and other persons directly responsible according to law; if a crime is constituted, criminal responsibility shall be investigated according to law:

(1) Issuing a license to a unit that does not meet the requirements of these Regulations or approving the import or transfer of radioactive isotopes to a unit that does not meet the requirements of these Regulations;

(2) Units that have not obtained a license according to law are found to produce, sell or use radioactive isotopes and radiological devices without authorization, and are not investigated and dealt with according to law after receiving a report;

(3) Those who discover that they import or transfer radioactive isotopes without authorization according to law and refuse to investigate and deal with them according to law after receiving reports;

(4) Those who fail to perform their supervisory and administrative duties or find violations of the provisions of these Regulations by units that have obtained licenses according to law shall not be investigated and punished;

(3) If the waste radioactive sources are returned to the production unit, to the original exporter or to the centralized storage unit of radioactive waste for storage, they have not been filed in accordance with the provisions.

Article 57 Any unit that, in violation of the provisions of these Regulations, produces, sells or uses radioactive isotopes and radiological devices shall be ordered by the competent environmental protection department of the people's government at or above the county level to stop the illegal act and make corrections within a time limit; if it fails to make corrections within the time limit, it shall be fined not less than 10,000 yuan but not more than 100,000 yuan:

(1) The use of radioisotopes and radiological devices outdoors and in the field fails to delineate safety protection areas and set up obvious radiological markers in accordance with the requirements of relevant national safety and protection standards;

(2) Unauthorized radioisotope tracing tests in the field. Article 58 Any unit that produces radioisotopes in violation of the provisions of these Regulations shall be ordered by the competent environmental protection department of the people's government at or above the county level to make corrections within a time limit and give a warning; if it fails to make corrections within the time limit, it shall collect its unrecorded radioisotopes and uncoded radioactive sources in accordance with the law and shall be sentenced to more than 50,000 yuan and more than 100,000 yuan. A fine of less than 10,000 yuan may be temporarily withheld or revoked by the original license issuing authority:

(1) No account for radioisotope products has been established;

(2) Failing to uniformly code the radioactive sources produced in accordance with the coding rules formulated by the competent environmental protection department under the State Council;

(3) Failing to submit the account of radioisotope products and the list of codes of radioactive sources to the competent department of environmental protection under the State Council for the record;

(4) Exporting or selling radioactive isotopes and uncoded radioactive sources not included in the product ledger.

Article 59 If a unit that produces, sells or uses radioisotopes or radiological devices in violation of the provisions of these Regulations commits one of the following acts, the competent environmental protection department of the people's government at or above the county level shall order it to stop the illegal act and make corrections within a time limit; if it fails to make corrections within the time limit, the original issuing authority shall designate a unit capable of handling the acts. For the purpose of handling or implementing decommissioning, the expenses shall be borne by the units producing, selling and using radioisotopes and radiological devices, and a fine of more than 10,000 yuan and less than 100,000 yuan shall be imposed:

(1) Failing to dispose of waste radioactive sources in accordance with regulations;

(2) Those who fail to decommission the places where the radioactive sources of Class I, Class II and Class III are used and where the radioactive isotopes are produced, as well as the radioactive contamination radiation devices after the termination of operation.

Article 60 If a unit that produces, sells or uses radioisotopes or radiological devices in violation of the provisions of these Regulations commits one of the following acts, the competent environmental protection department of the people's government at or above the county level shall order it to stop its illegal acts and make corrections within a time limit; if it fails to make corrections within the time limit, it shall be ordered to stop production and shut down its business and shall be sentenced to 20,000 yuan or less than 200, Penalty imposed on a person who commits a crime shall be investigated for criminal responsibility according to law:

(1) Failing to assess the safety and protection of radioisotopes and radiological devices in accordance with the regulations or failing to rectify potential safety hazards in time;

(2) The places where radioactive isotopes and radiological devices are produced, sold, used and stored are not provided with safety and protective facilities and radiological markers in accordance with regulations.

Article 61 If a radiation accident is caused in violation of the provisions of these Regulations, the original license issuing authority shall order it to make corrections within a time limit and impose a fine of not less than 50,000 yuan but not more than 200,000 yuan; if the circumstances are serious, the license shall be revoked by the original license issuing authority; if the violation of public security administration is constituted, the public security organ shall impose public security penalties according to law; if the violation is serious, the license shall Criminal responsibility shall be investigated according to law. Those who cause damage to others due to radiation accidents shall bear civil liability according to law.

Article 62 Units producing, selling and using radioisotopes and radiological devices shall be ordered to make rectification within a time limit. If they fail to make rectification within the time limit or fail to meet the requirements of the original license after rectification, the license shall be temporarily withheld or revoked by the original license issuing authority.

Article 63 Units that violate the provisions of these Regulations and have their licenses revoked or forged or altered according to law may not apply for a license within five years.

Article 64 The division of administrative penalty powers of competent environmental protection departments of local people's governments at or above the county level shall be determined by the people's governments of provinces, autonomous regions and municipalities directly under the Central Government.

Chapter VII Supplementary Provisions

Article 65 The supervision and management of the safety and protection of military radioisotopes and radiological devices shall be carried out in accordance with the provisions of Article 60 of the Law of the People's Republic of China on the Prevention and Control of Radioactive Pollution.

Article 66 The prevention and control of occupational diseases caused by workers'exposure to radioactive isotopes and radiation devices in their occupational activities shall be carried out in accordance with the Law of the People's Republic of China on the Prevention and Control of Occupational Diseases and the relevant provisions of the State Council.

Article 67 The transportation of radioactive isotopes and the disposal of radioactive waste generated during the production, sale and use of radioactive isotopes and radiological devices shall be carried out in accordance with the relevant provisions of the State Council.

Article 68 The meanings of the following terms in these Regulations: Radioisotopes refer to nuclides with the same atomic number but different mass in an element that undergoes radioactive decay.

Radioactive sources refer to radioactive materials that are permanently sealed in containers or are tightly clad and solid in addition to materials in the nuclear fuel cycle of research reactors and power reactors. X-ray devices refer to X-ray machines, accelerators, neutron generators and devices containing radioactive sources. Non-sealed radioactive material refers to the radioactive material which is not permanently sealed in the cladding or tightly consolidated in the covering . Transfer refers to the transfer of ownership or use rights of radioisotopes between different holders, except for import, export and recovery activities.

Electrical products accompanied by X-ray production refer to electrical products that do not produce X-ray for the purpose, but produce X-ray in the process of production or use. Radiation accidents refer to the loss, theft and out of control of radioactive sources, or the uncontrolled use of radioisotopes and radiation devices, which results in the accidental abnormal exposure of personnel.

Article 69 These Regulations shall come into force on December 1, 2005. The Regulations on Radioactive Protection of Radioisotopes and Radioactive Devices promulgated by the State Council on October 24, 1989 shall be repealed at the same time.