Radioactive isotope and radiation device safety permit management measures

(On January 18, 2006, the State Environmental Protection Administration Order No. 31 was promulgated according to the "Administrative Measures on the Safety Licensing of Radioisotopes and Radiation Devices" adopted by the Ministry of Environmental Protection at the 2nd Ministerial Conference of the Ministry of Environmental Protection on November 21, 2008. Decision "amendment"

Chapter I General Provisions

Article 1 These Measures are formulated for the implementation of the Radiation Safety Permit System stipulated in the Regulations on the Safety and Protection of Radioisotopes and Radiation Devices.

Article 2 Units that produce, sell or use radioisotopes and radiation devices within the territory of the People's Republic of China (hereinafter referred to as "radiation work units") shall obtain radiation safety licenses (hereinafter referred to as "licenses") in accordance with the provisions of these Measures. .

Import and transfer of radioisotopes and conducting radioisotope field tracing tests shall be submitted for approval in accordance with the provisions of these Measures.

The export of radioisotopes shall be handled in accordance with the provisions of these Measures.

Where a radioisotope is used by a unit using a radioisotope to be used by a province, autonomous region or municipality directly under the Central Government, it shall be filed in accordance with the provisions of these Measures.

The radioisotopes referred to in these Measures include radioactive sources and unsealed radioactive materials.

Article 3 According to the degree of potential harm to human health and the environment of radioactive sources and radiation devices, from high to low, the radioactive sources are classified into Class I, Class II, Class III, Class IV, Class V, and the radiation device is divided into I. Class, Class II, Class III.

Article 4 The licenses for the production of radioisotopes, the sale and use of Class I radioactive sources, and the sale and use of Class I radiation devices shall be examined and approved by the competent department of environmental protection under the State Council.

The licenses for radiation work units other than those specified in the preceding paragraph shall be examined and approved by the competent department of environmental protection of the people's government of the province, autonomous region or municipality directly under the Central Government (hereinafter referred to as “provincial environmental protection authority”).

A radiation work unit that produces, sells, or uses multiple types of radioactive sources, radiation devices, or unsealed radioactive materials requires only one license.

If the radiation work unit needs to apply for a permit to the environmental protection department of the State Council and the provincial environmental protection department at the same time, the license shall be examined and approved by the environmental protection department of the State Council.

The competent department of environmental protection shall notify the public security department and the competent health department at the same level of the approval and issuance of the permit.

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 higher level to approve and issue licenses.

Article 6 The competent department of environmental protection under the State Council shall be responsible for the examination and approval of the import of radioisotopes included in the restricted import and export catalogue.

The competent department of environmental protection under the State Council shall, in accordance with 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 restricted by the 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) transferring radioisotopes to other provinces, autonomous regions and municipalities directly under the Central Government;

(3) Field tracing tests for radioisotopes; however, radioisotope field tracing tests that may cause environmental impacts across provinces shall be examined and approved by the competent department of environmental protection under the State Council.

Chapter II Application and Issuance of Licenses

Article 7 Before applying for a permit, the radiation work unit shall organize the preparation or completion of the environmental impact assessment document and report it to the competent department of environmental protection for 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 prepared by an organization with the corresponding environmental impact assessment qualification.

Article 8 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.

Activities for the transfer of radioisotopes and radiographs do not require the preparation of environmental impact assessment documents.

Article 9 If a radiation work unit applying for a permit engages in the following activities, it shall organize the preparation of an environmental impact report:

(1) Production of radioisotopes (except for the preparation of radiopharmaceuticals for PET);

(2) The use of Class I radioactive sources (except for medical use);

(3) Sales (including construction) and use of Class I radiation devices.

Article 10 If a radiation working unit applying for a permit engages in the following activities, it shall organize the preparation of an environmental impact report form:

(1) preparing radiopharmaceuticals for PET;

(2) selling Class I, Class II, Class III radioactive sources;

(3) Medical use of Class I radioactive sources;

(4) using Class II and Class III radioactive sources;

(5) Producing, selling and using Class II radiation devices.

Article 11 If a radiation working unit applying for a permit engages in the following activities, it shall report the environmental impact registration form:

(1) selling and using Class IV and Class V radioactive sources;

(2) Producing, selling and using Class III radiation devices.

Article 12 When a radiation work unit organizes or prepares an environmental impact assessment document, it shall evaluate it according to the scale of production, sales and use of the radioisotope and radiation device designed and designed by it.

The environmental impact assessment documents referred to in the preceding paragraph shall, in addition to being prepared or filled in accordance with the requirements of the relevant national environmental impact assessment, shall also include the evaluation of the technical capabilities, radiation safety and protective measures of the radiation work units engaged in the corresponding radiation activities.

Article 13 Where a unit producing radioisotopes applies for a permit, it shall meet the following conditions:

(1) There is a special radiation safety and environmental protection management agency.

(2) There are not less than 5 technical personnel in nuclear physics, radiochemistry, nuclear medicine and radiation protection, among which there are no less than one with senior professional titles.

For units producing radioisotopes with a half-life of more than 60 days, the number of professional technicians referred to in the preceding paragraph shall be no less than 30, of which not less than 6 shall have senior titles.

(3) Personnel engaged in radiation work must pass the training and assessment of radiation safety and protection expertise and relevant laws and regulations. The key positions for radiation safety shall be the registered nuclear safety engineers.

(4) There are radioisotope production sites, production facilities, temporary storage or temporary storage equipment that are compatible with the design and production scale, meet the requirements of radiation safety and protection, and physical protection, and have ownership of production sites and production facilities.

(5) Packaging containers for transporting and storing radioisotopes in accordance with relevant national regulations.

(6) A transportation vehicle that meets the requirements for national radioisotope transportation and is equipped with a full-time driver who has been driving for more than 5 years.

(7) Equipped with protective equipment and monitoring instruments that are compatible with radiation type and radiation level, including personal dose measurement alarms, fixed and portable radiation monitoring, surface contamination monitoring, and effluent monitoring.

(8) Establish and improve operational procedures, job responsibilities, radiation protection systems, safety and security systems, equipment maintenance and repair systems, personnel training systems, account management systems and monitoring programs.

(9) Establish an emergency response agency, formulate an emergency response plan and a training and drill system for emergency personnel, have necessary emergency equipment and materials preparation, and have emergency response handling capabilities appropriate to the design and production scale.

(10) It has the processing capacity or feasible treatment plan to ensure the discharge of radioactive waste gas, waste liquid and solid waste.

Article 14 Where a unit that sells radioisotopes applies for a permit, it shall meet the following conditions:

(1) There is a special radiation safety and environmental protection management organization, or at least one technician with bachelor degree or above is responsible for radiation safety and environmental protection management.

(2) Personnel engaged in radiation work must pass the training and assessment of radiation safety and protection expertise and relevant laws and regulations.

(3) Temporary storage or equipment that needs to temporarily store radioisotopes and meet the requirements of radiation safety and protection and physical protection.

(4) Installation and commissioning of radioisotopes are required, and there are installation and debugging places that meet the requirements of preventing accidental operation and preventing accidental exposure of workers and the public.

(5) Packaging containers for storing and transporting radioisotopes in accordance with relevant national regulations.

(6) Transporting radioisotopes can use transport vehicles that meet the national radioisotope transport requirements.

(7) Equipped with protective equipment and monitoring instruments suitable for radiation type and radiation level, including personal dose measurement alarm, portable radiation monitoring, surface pollution monitoring and other instruments.

(8) It has sound operating procedures, job responsibilities, safety and security systems, radiation protection measures, account management systems, personnel training plans and monitoring programs.

(9) There are perfect emergency measures for radiation accidents.

Article 15 The units that produce and sell the radiation equipment shall apply for the following conditions:

(1) There is a special radiation safety and environmental protection management institution, or at least one technician with bachelor degree or above is responsible for radiation safety and environmental protection management.

(2) Personnel engaged in radiation work must pass the training and assessment of radiation safety and protection expertise and relevant laws and regulations.

(3) The production and debugging places of the radiation equipment meet the safety requirements for preventing accidental operation and preventing accidental exposure of workers and the public.

(4) Equipped with necessary protective equipment and monitoring equipment.

(5) It has sound operating procedures, job responsibilities, radiation protection measures, account management system, training plan and monitoring plan.

(6) There are emergency measures for radiation accidents.

Article 16 Where a unit using a radioisotope or a radiation device applies for a permit, the following conditions shall be met:

(1) If Class I, Class II or Class III radioactive sources are used and Class I or Class II radiation devices are used, special radiation safety and environmental protection management agencies shall be provided, or at least one technician with bachelor degree or above shall be provided. Full-time responsibility for radiation safety and environmental protection management; other radiation work units should have a technical staff with college education or above to take full-time or part-time responsibility for radiation safety and environmental protection management; according to the radiation safety key job list, radiation safety key positions should be established The post should be a registered nuclear safety engineer.

(2) Personnel engaged in radiation work must pass the training and assessment of radiation safety and protection expertise and relevant laws and regulations.

(3) The unit using the radioisotope shall have a temporary storage bank or equipment that meets the requirements for radiation protection and physical protection.

(4) Safety measures for the prevention of misuse and prevention of accidental exposure of workers and the public in the use of radioisotopes and radiation devices.

(5) Equipped with protective equipment and monitoring instruments that are compatible with radiation type and radiation level, including personal dose measurement alarms, radiation monitoring and other instruments. Units that use unsealed radioactive materials should also have surface contamination monitors.

(6) It has sound operational procedures, job responsibilities, radiation protection and safety protection systems, equipment maintenance and repair systems, radioisotope use registration systems, personnel training plans, and monitoring programs.

(7) There are perfect emergency measures for radiation accidents.

(8) The production of radioactive waste gas, waste liquid or solid waste shall also have the processing capacity or feasible treatment plan to ensure the discharge of radioactive waste gas, waste liquid and solid waste.

Units that use radioisotopes and radiation devices for diagnosis and treatment should also be equipped with quality control testing equipment, develop corresponding quality assurance programs and quality control testing plans, and at least one medical physicist is responsible for quality assurance and quality control testing.

Article 17 The purchased radioactive source shall be assembled in the radiation working unit sold in the equipment, and the license shall be obtained in accordance with the sale and use of the radioisotope.

Article 18 A radiation work unit applying for a permit shall submit the following materials to the competent department of environmental protection with the power of examination and approval:

(1) Application Form for Radiation Safety Permit (see Annex 1);

(2) The original copy of the business license of the legal person, the copy or the original copy of the legal person certificate, and the original copy of the legal representative's ID card and their copy, and a copy after the examination;

(3) The approved environmental impact assessment documents;

(4) Proof materials satisfying the corresponding provisions of Articles 13 to 16 of these Measures;

(5) A list of existing and proposed new sources of radioactive sources and radiation devices.

Article 19 When accepting an application, the competent department of environmental protection shall inform the applicant to apply for a permit according to the planned design scale of the production, sale and use of the radioisotope and radiation device described in the environmental impact assessment document.

The competent department of environmental protection shall complete the examination within 20 working days from the date of accepting the application. If the conditions are met, the permit shall be issued and announced; if the conditions are not met, the applicant shall be notified in writing and the reasons shall be explained.

Article 20 The license includes the following main contents:

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

(2) The type and scope of the activities undertaken;

(3) the period of validity;

(4) Date of issue and certificate number.

The types of activities in the license are divided into three categories: production, sales and use; the scope of activities refers to the category, total activity and type and quantity of all radioisotopes produced, sold and used by the radiation work unit.

The license is divided into the original and the copy (see Appendix 2 for the specific format and content), which are equally valid.

Article 21: Radiation work units that have obtained licenses to produce, sell, and use high-grade radioisotopes and radiation devices, engage in the production, sale, and use of low-level radioisotopes and radiation devices, and do not need to apply for lower categories. License for radioisotopes and radiation devices.

Article 22 If the radiation work unit changes the name, address and legal representative of the unit, it shall, within 20 days from the date of registration of the change, apply to the original issuing authority for the procedure for changing the license, and provide the following relevant materials:

(1) A license change application report;

(2) A copy of the business license of the enterprise legal person or the legal person certificate of the institution after the change;

(3) Positive and duplicate licenses.

After the original issuing authority has examined and approved, the license will be renewed.

Article 23 In any of the following circumstances, the license-issuing unit shall apply for a permit again in accordance with the permit application procedure stipulated in these Measures:

(1) changing the type or scope of activities specified in the license;

(2) Newly built or rebuilt or expanded production, sales or use of facilities or places.

Article 24 The license is valid for 5 years. If the expiration date expires and needs to be extended, the continuation application shall be submitted to the original issuing authority 30 days before the expiration of the validity period of the permit, and the following materials shall be provided:

(1) A permit renewal application report;

(2) Monitoring report;

(3) Summary of radiation safety protection work during the validity period of the license;

(4) Positive and duplicate licenses.

The original issuing authority shall complete the examination before the expiration of the validity period of the permit from the date of acceptance of the application for renewal. If the conditions are met, the license shall be extended, the license shall be renewed, and the original license number shall be used; if the conditions are not met, the written notice shall be filed. The unit also explains the reasons.

Article 25 If the radiation working unit partially terminates or terminates the production, sale or use of radioisotope and radiation device activities, it shall submit an application for partial change or cancellation of the license to the original issuing authority, and after the original issuing authority has passed the verification, it shall Change or cancel the license.

Article 26 If a radiation work unit loses its license for any reason, it shall promptly publish a notice of loss in the local provincial newspapers and periodicals, and shall, within one month after the announcement 30 days, submit an announcement to the original issuing authority for reissue.

Chapter III Approval and Filing of Import, Export, Transfer and Transfer Activities

Article 27 Units imported into the radioisotope restricted by the import and export catalogue shall be submitted to the competent department of environmental protection under the State Council for examination and approval before import; after obtaining approval, the competent foreign trade department of the State Council shall issue an import license in accordance with the relevant provisions of foreign trade. . The competent department of environmental protection under the State Council shall give the source code of the radioactive source when it approves the application for import of radioactive sources.

Units that import unsealed radioactive materials in batches shall be reported to the competent department of environmental protection under the State Council for examination and approval once every six months.

Article 28 Anyone applying for import of radioisotopes listed in the restricted import and export catalogue shall submit an approval form for the import of radioisotopes to the competent department of environmental protection under the State Council and submit the following materials:

(1) A copy of the import unit license;

(2) The treatment plan after the expiration of the use of radioisotopes, in which the import of Class I, Class II or Class III radioactive sources shall provide a copy of the commitment documents of the original exporter responsible for recycling the radioactive source from the end user;

(3) Photocopies or copies of the clear label of the imported radioactive source and the necessary explanatory documents, wherein the labels of Class I, Class II and Class III radioactive sources shall be engraved on the source of the radioactive source or the casing of the sealed package, IV The labels of Class V and Class V sources shall be recorded in the corresponding documents;

(4) A copy of the effective agreement signed between the importing unit and the original exporter;

(5) If the imported radioisotope is sold to other units, a copy of the valid agreement signed with the user and a copy of the unit license shall be provided.

The specific format and content of the radioisotope import approval form are shown in Annex III.

Article 29 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 for import of radioisotopes. If the conditions are met, it shall be approved; if the conditions are not met, the applicant shall be notified in writing and the reasons shall be explained.

The importing unit and the user unit shall, within 20 days from the date of completion of the import activity, submit the approved radioisotope import approval form to the provincial environmental protection department in their respective locations.

Article 30 Units that export to include radioisotopes that restrict import and export catalogues shall submit the radioisotope export form to the environmental protection department of the State Council and submit the following materials:

(1) A copy of the export unit license;

(2) Foreign importers may legally hold Chinese or English certification materials for radioisotopes;

(3) A copy of the effective agreement signed between the exporting unit and the foreign importer.

The specific format and content of the radioisotope export table can be found in Annex IV.

The exporting unit shall submit the radioisotope export form to the provincial provincial environmental protection department within 20 days from the date of completion of the export activity.

Units that export radioisotopes should abide by the relevant provisions of the state's foreign trade.

Article 31 Where a radioisotope is transferred, the transferring unit shall report to the local provincial environmental protection department for examination and approval before each transfer.

If the unsealed radioactive material is transferred in batches, the transfer unit may report to the local provincial environmental protection authority for review and approval every six months.

Radioisotopes can only be transferred between units holding licenses. It is prohibited to transfer radioisotopes to units that are not licensed or that exceed the type and scope of the license.

Radioisotopes may not be transferred without approval.

Article 32 Units that have been transferred to radioisotopes shall submit a radioisotope transfer approval form to the local provincial environmental protection authority before the transfer, and submit the following materials:

(1) A permit to transfer or transfer to the unit;

(2) The treatment plan after the expiration of the use of radioisotopes;

(3) Transferring the transfer agreement signed by both parties.

The specific format and content of the radioisotope transfer approval form are shown in Annex V.

The competent department of environmental protection shall complete the examination within 15 working days from the date of accepting the application. If the conditions are met, the approval shall be granted; if the conditions are not met, the applicant shall be notified in writing and the reasons shall be explained.

Article 33 Units that transfer or transfer radioisotopes shall, within 20 days from the date of completion of the transfer activities, submit a copy of the radioisotope transfer approval form to the provincial-level environmental protection authorities at their respective locations.

Article 34 Units conducting radioisotope tracer tests in the field shall prepare an environmental impact report form before each test, and may proceed after examination and approval by the relevant provincial environmental protection authorities at the same level.

If the radioisotope field tracer test may cause cross-provincial environmental impact, its environmental impact report form shall be submitted to the relevant department of environmental protection at the same level for review and approval by the competent department of environmental protection under the State Council.

Article 35 Where a unit using a radioisotope needs to transfer a radioisotope to a foreign province, autonomous region or municipality directly under the Central Government, it shall, within 10 days prior to the implementation of the activity, file a copy of the permit with the provincial environmental protection department at the place of use, and the written report shall be removed. At the provincial level, the competent department of environmental protection shall be subject to the supervision and administration of the competent department of environmental protection at the place of use.

The contents of the written report shall include the radionuclide, activity, time and place of transfer, radiation safety person in charge and contact telephone number; the source of the transfer shall also provide the source code and code.

The use unit shall, within 20 days after the end of the activity, go to the provincial environmental protection department at the place of use to go through the formalities for registration and cancellation, and notify the provincial environmental protection department in writing.

Chapter IV Supervision and Management

Article 36 Radiation work units shall engage in the production, sale and use of radioisotopes and radiation devices in accordance with the provisions of the permit.

It is prohibited to engage in the production, sale or use of radioisotopes and radiation devices without a license or in accordance with the types and scope of the license.

Article 37 Units that produce radioisotopes and radiation devices shall set up obvious radioactive identification and Chinese warning instructions on the packaging containers of radioisotopes, equipment containing radioisotopes and radiation devices; if radioactive signs can be set on the radioactive sources, It should be set together.

The instructions for the equipment containing the radioactive source shall inform the user that the equipment contains the radioactive source and its related technical parameters and structural characteristics, and inform the radioactive source of the potential radiation hazard and the corresponding safety precautions.

Article 38 Units that produce or import radioactive sources shall, when selling Class I, Class II, and Class III radioactive sources, sign a contract for the return of used radioactive sources with the unit that uses the radioactive source.

Units using Class I, Class II, and Class III radioactive sources shall return the used radioactive sources to the production unit or return to the original exporting party within 3 months after the radioactive source is idle or abandoned, in accordance with the contract for the return of the waste radioactive source. If it is indeed impossible to return it to the production unit or return to the original exporter, it shall be sent to the centralized storage unit of the radioactive waste with corresponding qualifications for storage.

Units using Class IV and Class V radioactive sources shall, in accordance with the provisions of the competent department of environmental protection under the State Council, package and dispose of the used radioactive sources within three months after the radioactive source is idle or abandoned, and then deliver them to the centralized storage unit for radioactive waste with corresponding qualifications. Storage.

The unit using the radioactive source shall file with the competent provincial environmental protection department within 20 days from the date of completion of the return, return or delivery of the waste radioactive source.

Article 39 The waste radioactive sources that have been stored by the units that sell or use radioactive sources before the implementation of these Measures shall be returned to the radioactive source production unit or returned to the original exporter within one year from the date of implementation of these Measures, or sent to A corresponding centralized storage unit for radioactive waste.

Article 40 The places where radioisotopes are produced, the places where radioactive isotopes of radioactive contamination are sold and used, the radiation devices that produce radioactive pollution and their places shall be decommissioned according to law after the termination of operation. After the completion of the decommissioning, the relevant radiation work unit may apply for the change or cancellation of the permit.

Article 41 The radiation work unit shall establish a radioactive isotope and radiation device account, record the radionuclide name, time and activity, label, code, source and destination of the radioisotope, and the name, model and type of the radiation device. , categories, uses, sources and whereabouts.

Radioisotope and radiation device ledgers, personal dose files and occupational health surveillance files should be kept for a long time.

Article 42 The radiation work unit shall prepare an annual assessment report on the safety and protection status of radioisotopes and radiation devices, and report it to the original issuing authority before January 31 of each year.

The annual assessment report should include the radioisotope and radiation device ledger, the operation and maintenance of radiation safety and protection facilities, the establishment and implementation of radiation safety and protection systems and measures, accidents and contingency, and file management.

Article 43 The competent department of environmental protection of the people's government at or above the county level shall supervise and inspect the radiation work unit. For the existing problems, it shall submit written on-site inspection opinions and rectification requirements, which shall be signed by the inspectors or sealed by the inspection unit. The unit being inspected and archived by the unit under inspection.

Article 44 The competent department of environmental protection at the provincial level shall prepare an annual summary report on the supervision and management of radiation work units, and report it to the competent department of environmental protection under the State Council before March 1 of each year.

The contents of the report should include the number of radiation work units, the number and type of radioactive sources, the number and type of radiation devices, the issuance and cancellation of licenses, accidents and their handling, supervision and inspection and punishment.

Chapter 5 Penalties

Article 45 If a radiation working unit violates the relevant provisions of these Measures and has one of the following acts, the competent department of environmental protection of the people's government at or above the county level shall order it to stop the illegal act and correct it within a time limit; if it fails to make corrections within the time limit, it shall be more than 10,000 yuan. A fine of less than 30,000 yuan:

(1) failing to inform the user in the instructions containing the radioactive source device that the device contains a radioactive source;

(2) The unit that sells or uses the radioactive source fails to return, return or send the used radioactive source stored in the relevant unit to the relevant unit within one year from the date of implementation of these Measures.

Radiation work units violate the other provisions of these Measures and are punished in accordance with the Law of the People's Republic of China on Prevention and Control of Radioactive Pollution, the Regulations on the Safety and Protection of Radioisotopes and Radiation Devices, and other relevant laws and regulations.

Chapter VI Supplementary Provisions

Article 46 The competent department of environmental protection of the people's government at or above the provincial level shall be responsible for issuing certification documents for the exemption from the management of radioisotopes and radiation devices in accordance with the Basic Standards for the Protection of Ionizing Radiation and Radiation Sources (GB18871-2002) and relevant state regulations.

Article 47 These Measures shall come into force on March 1, 2006.

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