Measures for the Administration of Safety Licenses for Radioisotopes and Radiation Devices (Amendment 2008)

(Decree No. 3 of the Ministry of Environmental Protection)

The Decision on Amending the Measures for the Administration of Safety Licensing for Radioisotopes and Radioactive Devices has been considered and approved by the Ministry of Environmental Protection at its ministerial meeting on November 21, 2008, and is now promulgated and implemented.

Minister of Environmental Protection Zhou Shengxian

December 6, 2008

Decision on Revising the Measures for the Administration of Safety Licensing of Radioisotopes and Radiation Devices

The Ministry of Environmental Protection has decided to amend the Measures for the Administration of Safety Licensing for Radioisotopes and Radiation Devices as follows:

Article 10 is amended as follows: "If a radiation work unit applying for a license engages in the following activities, it shall organize the preparation of an environmental impact report form:

(1) The preparation of radioactive drugs for PET;

(2) Sales of Class I, Class II and Class III radioactive sources;

(3) Medical use of Class I radioactive sources;

(4) The use of type II and III radioactive sources;

(5) Production, sale and use of type II radiation devices."

Article 11 is amended as follows: "If a radiation work unit applying for a license engages in the following activities, it shall fill in an environmental impact registration form:

(1) Selling and using category IV and V radioactive sources;

(2) Production, sale and use of category III radiation devices."

This decision shall come into force as of the date of promulgation.

The Measures for the Administration of Safety Licensing for Radioisotopes and Radiation Devices shall be revised and re-published in accordance with this Decision.

Management Measures for Safety License of Radioisotopes and Radiation Devices

(Decree No. 31 of the State Environmental Protection Administration of 18 January 2006 promulgated the amendment to the Measures for the Administration of Safety Licenses for Radioisotopes and Radiation Devices, adopted by the Ministry of Environmental Protection at its 2nd ministerial meeting on 21 November 2008.

Amendment to Decision)

Chapter I General Provisions

Article 1 These Measures are formulated to implement the radiation safety licensing system stipulated in the Regulations on the Safety and Protection of Radioactive Isotopes and Radioactive Devices.

Article 2 Units producing, selling and using radioactive isotopes and radiation devices within the territory of the People's Republic of China (hereinafter referred to as "radiation work units") shall obtain radiation safety permits (hereinafter referred to as "permits") in accordance with the provisions of these Measures. The import and transfer of radioisotopes and the field tracer test of radioisotopes shall be submitted for approval in accordance with the provisions of these Measures. The export of radioactive isotopes shall go through relevant formalities in accordance with the provisions of these Measures.

Units that use radioisotopes to transfer radioisotopes to other provinces, autonomous regions and municipalities directly under the Central Government for use shall file for the record in accordance with the provisions of these Measures.

The radioactive isotopes referred to in these Measures include radioactive sources and non-sealed radioactive substances.

Article 3 According to the potential harmfulness of radiation sources and radiation devices to human health and the environment, from high to low, radiation sources are classified into categories I, II, III, IV and V, and radiation devices are classified into categories I, II and III.

Article 4 Radiation work in the production of radioisotopes, the sale and use of category I radioactive sources, the sale and use of category I radiological devices

The license of the entity shall be examined and approved by the competent environmental protection department under the State Council.

Licenses for radiation work units other than those specified in the preceding paragraph shall be examined and issued by the competent environmental protection authorities of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government (hereinafter referred to as "provincial environmental protection authorities").

If a radiation work unit produces, sells or uses a variety of radiation sources, radiation devices or non-sealed radioactive substances, it only needs to apply for a permit.

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

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 5 The competent environmental protection authorities of the people's governments at or above the provincial level may entrust the competent environmental protection authorities of the people's governments at the next level to examine, approve and issue licenses.

Article 6 The competent department of environmental protection under the State Council shall be responsible for examining and approving the import of radioactive isotopes listed in the catalogue of import and export restrictions.

The competent department of environmental protection under the State Council shall, in accordance with the relevant laws of our country and the provisions of international treaties and agreements concluded or acceded to, handle the relevant formalities for the export of radioactive isotopes listed in the catalogue of restrictions on import and export.

The provincial environmental protection authorities are responsible for the examination and approval or filing of the following activities:

(1) Transfer of radioisotopes;

(2) Transfer radioisotopes to other provinces, autonomous regions and municipalities directly under the Central Government for use;

(3) Radioisotope field tracer test; however, the field tracer test of radioisotope which may cause trans-provincial environmental impact shall be examined and approved by the competent environmental protection department under the State Council.

Chapter II Application and Issuance of Licenses

Article 7 Before applying for a permit, radiation work units shall organize the preparation or filing of environmental impact assessment documents and submit them to the competent environmental protection authorities for examination and approval in accordance with the procedures prescribed by the State.

Environmental impact reports or environmental impact reports in environmental impact assessment documents shall be prepared by institutions with corresponding qualifications for environmental impact assessment.

Article 8 The environmental impact assessment documents shall be classified and managed according to the safety and protection requirements of radioisotopes and radiological devices and their impact on the environment.

The transfer of radioisotopes and radiological devices does not require the preparation of environmental impact assessment documents.

Article 9 A radiation work unit applying for a license shall organize the preparation of an environmental impact report if it engages in the following activities:

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

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

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

Article 10 A radiation work unit applying for a license shall organize the preparation of an environmental impact report for the following activities:

(1) The preparation of radioactive drugs for PET;

(2) Sales of Class I, Class II and Class III radioactive sources;

(3) Medical use of Class I radioactive sources;

(4) The use of type II and III radioactive sources;

(5) Production, sale and use of type II radiation devices.

Article 11 A radiation work unit applying for a license shall fill in an environmental impact registration form if it engages in the following activities:

(1) Selling and using category IV and V radioactive sources;

(2) Production, sale and use of category III radiation devices.

Article 12 When organizing and compiling environmental impact assessment documents, radiation work units shall evaluate the scale of production, sale and use of radioisotopes and radiological devices designed and planned by them.

The environmental impact assessment documents referred to in the preceding paragraph shall include, in addition to compiling or filling in in accordance with the requirements of the State for environmental impact assessment, the contents of evaluating the technical capabilities, radiation safety and protection measures of radiation work units engaged in corresponding radiation activities.

Article 13 Units producing radioactive isotopes shall meet the following requirements when applying for a license:

(1) There are special radiation safety and environmental protection management agencies.

(2) There are not less than five technicians in nuclear physics, radiochemistry, nuclear medicine and radiation protection, among whom no less than one has a senior .

For units producing radioisotopes with a half-life of more than 60 days, the number of professional and technical personnel referred to in the preceding paragraph shall be no less than 30, of which no less than 6 have senior professional s.

(3) Personnel engaged in radiation work must pass the training and assessment of radiation safety and protection professional knowledge and relevant laws and regulations, in which key positions of radiation safety shall be held by registered nuclear safety engineers.

(4) There are radioactive isotope production sites, production facilities, temporary storehouses or temporary storage facilities that meet the requirements of radiation safety and protection and physical security, and possess the ownership of production sites and production facilities in accordance with the design and production scale.

(5) Packaging containers for transporting and storing radioactive isotopes that meet the requirements of the relevant provisions of the State.

(6) It has a transport vehicle that meets the requirements of the state for transporting radioactive isotopes and is equipped with a full-time driver of more than five years'driving age.

(7) Equipped with protective equipment and monitoring instruments suitable for radiation types and levels, including personal dosimetry alarm, fixed and portable radiation monitoring, surface pollution monitoring, effluent monitoring and other equipment.

(8) Establish and improve operational procedures, post responsibilities, radiation protection system, safety and security system, equipment maintenance system, personnel training system, account management system and monitoring program.

(9) Establishing emergency response agencies, formulating emergency response plans and training exercises for emergency personnel, making necessary emergency equipment and material preparation, and having emergency response capacity corresponding to the design and production scale.

(10) Has the disposal capacity or feasible disposal scheme to ensure the discharge of radioactive waste gases, liquids and solid wastes up to the standard.

Article 14 Units selling radioactive isotopes shall meet the following requirements when applying for a license:

(1) There shall be a special radiation safety and environmental protection management agency, or at least one technician with bachelor's degree or above shall be responsible for the management of radiation safety and environmental protection.

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

(3) Where radioactive isotopes need to be temporarily stored, there are temporary storehouses or equipment that meet the requirements of radiation safety, protection and physical protection.

(4) Where it is necessary to install and debug radioactive isotopes, there are installations and debugging sites that meet the requirements of preventing misoperation and accidental exposure of workers and the public.

(5) Containers for storing and transporting radioactive isotopes that meet the requirements of relevant regulations of the State.

(6) Transport of radioactive isotopes can be carried by means of transport that meet the requirements of the state for transport of radioactive isotopes.

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

(8) There are sound operating procedures, post responsibilities, safety and security system, radiation protection measures, account management system, personnel training plan and monitoring program.

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

Article 15 When applying for a license, an entity that produces or sells radiographic devices shall meet the following requirements:

(1) There is a special radiation safety and environmental protection management organization, or at least one technician with bachelor's degree or above is in charge of radiation safety and environmental protection management.

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

(3) The production and debugging sites of radiation devices meet the safety requirements for preventing misoperation and accidental exposure of workers and the public.

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

(5) Perfect operating procedures, post responsibilities, radiation protection measures, account management system, training plans and monitoring programs.

(6) Emergency measures for radiation accidents.

Article 16 Units using radioactive isotopes and radiation devices shall meet the following requirements when applying for a license:

(1) Where category I, II and III radioactive sources are used and category I and II radiation devices are used, special radiation safety and environmental protection management agencies shall be established, or at least one technician with bachelor's degree or above shall be responsible for the management of radiation safety and environmental protection; other radiation work units shall be responsible for the management of radiation safety and environmental protection. One technician with a college degree or above is responsible for the management of radiation safety and environmental protection full-time or part-time. According to the list of key positions in radiation safety, key positions in radiation safety should be established, which should be held by registered nuclear safety engineers.

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

(3) Units using radioactive isotopes shall have temporary repositories or equipment of radioactive sources that meet the requirements of radiation protection and physical protection.

(4) Safety measures shall be taken to prevent misoperation and accidental exposure of workers and the public in the places where radioactive isotopes and radiation devices are used.

(5) Equipped with protective equipment and monitoring instruments suitable for radiation types and levels, including personal dose measurement and alarm, radiation monitoring and other instruments. Units that use non-sealed radioactive materials shall also have surface contamination monitors.

(6) There are sound operating rules, post responsibilities, radiation protection and safety system, equipment maintenance system, radioactive isotope use registration system, personnel training plan, monitoring program, etc.

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

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

Units that use radioisotopes and radiological devices for diagnosis and treatment shall also equip quality control testing equipment, formulate corresponding quality assurance outlines and quality control testing plans, and at least one medical physician shall be responsible for quality assurance and quality control testing.

Article 17 A radiation work unit that assembles purchased radioactive sources into equipment for sale shall apply for a license for the sale and use of radioactive isotopes.

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

(1) Application form for radiation safety permit (see Annex I);

(2) The original or duplicate of the business license of an enterprise as a legal person or the certificate of a public institution as a legal person, and the original identity card of the legal representative and its duplicate, and the duplicate shall be retained after examination;

(3) Documents of environmental impact assessment that have been examined and approved;

(4) Evidence materials meeting the corresponding provisions of Articles 13 to 16 of these Measures;

(5) Detailed lists of existing and proposed additional radiation sources and radiation installations in units.

Article 19 When accepting an application, the competent environmental protection authority shall inform the applicant unit to apply for a permit in accordance with the planned design scale for the production, sale and use of radioisotopes and radiological devices described in the EIA document.

The competent environmental protection department 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 20 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.

The types of activities in the license are divided into three categories: production, sale and use. The scope of activities refers to the categories of all radioactive isotopes produced, sold and used by radiation work units, the total activity and the types and quantities of radiation devices. The license is divided into original and duplicate (see Annex II for the specific format and content), which are equally valid.

Article 21 Radiation work units that have obtained licenses for the production, sale and use of high-level radioisotopes and radiological devices shall engage in the production, sale and use of low-level radioisotopes and radiological devices without applying for a separate license for low-level radioisotopes and radiological devices.

Article 22 If a radiation work unit changes its name, address and legal representative, it shall change its registration date.

Within 20 days, apply to the original license authority for the change of license and provide the following relevant materials: (1) the application report for the change of license;

(2) Copies of the original and duplicate of the business license of the enterprise legal person or the certificate of the institution legal person after the change;

(3) The original and duplicate licenses.

After examination and approval by the original license issuing authority, the license shall be renewed.

Article 23 In any of the following circumstances, the Licensee shall reapply for a license in accordance with the licensing application procedures prescribed in these Measures:

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

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

Article 24 The validity period of the license is five years. If the period of validity expires and needs to be extended, the period of validity of the license shall expire.

30. Apply for renewal to the original license issuing authority and provide the following materials: (1) Application report for renewal of license;

(2) Monitoring reports;

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

(4) The original and duplicate licenses.

The original license issuing authority shall complete the examination before the expiration of the validity period of the license from the date of accepting the application for renewal, and if it meets the requirements, it shall

To renew, renew and use the number of the original license; if it fails to meet the requirements, it shall notify the applicant in writing and explain the reasons.

Article 25 Where a radiation work unit partially terminates or completely terminates the production, sale or use of radioactive isotopes and radiation devices, it shall apply to the original license authority for a partial change or cancellation of the license. After verification by the original license authority, the license shall be changed or cancelled.

Article 26 If a radiation work unit loses its license for some reason, it shall publish the lost notice in the local provincial newspapers and periodicals in time, and apply to the original license issuing organ for reissue within one month after the announcement is made 30 days later.

Chapter III Examination, Approval and Recording of Import, Export, Transfer and Transfer Activities

Article 27 Units that import radioactive isotopes listed in the catalogue of restricted import and export shall submit them to the competent environmental protection department under the State Council for examination and approval before import. After approval, the competent foreign trade department under the State Council shall issue import licenses in accordance with the relevant provisions of foreign trade. When approving the application for import of radioactive sources, the competent environmental protection department under the State Council shall give the coding of radioactive sources.

Units that import non-sealed radioactive substances in batches shall submit them to the competent department of environmental protection under the State Council for examination and approval every six months. Article 28 Units applying for the import of radioactive isotopes listed in the catalogue of restricted import and export shall submit environmental protection to the State Council.

The competent nursing department shall submit the approval form for the import of radioactive isotopes and submit the following materials:

(1) Copies of licenses of importing units;

(2) Processing schemes after the expiration of the service life of radioactive isotopes, in which imports of radioactive sources of category I, II and III shall provide copies of the commitment documents of the original exporter responsible for recovering radioactive sources from the end-users;

(3) Photocopies or copies of the clear label of imported radioactive sources and the necessary documentation, of which Categories I, II, and

Class III radioactive source labels shall be engraved on the radiation source body or sealed enclosure, and Class IV and V radioactive source labels shall be

Recorded in the corresponding documentation;

(4) Copies of valid agreements signed between the importing unit and the original exporter;

(5) Where imported radioisotopes are sold to other units for use, copies of valid agreements signed with the user units and copies of licenses of the user units shall also be provided.

The specific format and contents of the approval form for importation of radioactive isotopes are shown in Annex III.

Article 29 The competent environmental protection department under the State Council shall complete the examination within 10 working days from the date of accepting the application for the import of radioactive isotopes, 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 importing units and users shall submit the approved forms for the import of radioactive isotopes to the provincial environmental protection authorities in their respective localities within 20 days from the date of completion of the import activities.

Article 30 Units exporting radioactive isotopes listed in the catalogue of import and export restrictions shall submit export forms of radioactive isotopes to the competent environmental protection department under the State Council and submit the following materials:

(1) A copy of the license of the exporting entity;

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

(3) Copies of valid agreements signed between export units and foreign importers.

The specific format and contents of the radioactive isotope export table are shown in Annex IV.

The exporting unit shall, within 20 days from the date of completion of the export activity, submit the radioactive isotope export statement to the provincial environmental protection authority where it is located.

Units exporting radioactive isotopes shall abide by the relevant provisions of the State on foreign trade.

Article 31 Where radioactive isotopes are transferred, the transferred unit shall report to the competent provincial environmental protection authority at the place where the transfer takes place for examination and approval before each transfer.

If the non-sealed radioactive substances are transferred in batches, the transferred units may report to the provincial environmental protection authorities for examination and approval every six months.

Radioisotopes can only be transferred between licensed units. It is forbidden to use unlicensed or exceeded licenses.

Units of category and scope transfer radioisotopes.

Radioactive isotopes shall not be transferred without approval.

Article 32 Units transferring radioisotopes shall submit to the competent environmental protection authorities at the provincial level in their locality a form for approval of the transfer of radioisotopes and submit the following materials before the transfer:

(1) Licenses for transferring or transferring to units;

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

(3) The transfer agreement signed by the two parties to the assignment.

The specific format and contents of the approval form for the transfer of radioisotopes 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, 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.

Article 33 Units transferring or transferring radioactive isotopes shall, within 20 days from the date of completion of the transfer, submit one copy of the approval form for the transfer of radioactive isotopes to the provincial environmental protection authorities at their respective locations.

Article 34 Units conducting radioisotope tracer tests in the field shall prepare an environmental impact report before each test and shall not carry out it until it has been examined and approved by the provincial environmental protection authorities at the test site in consultation with the relevant departments at the same level.

If the radioisotope field tracer test may cause trans-provincial environmental impact, the environmental impact report shall be submitted to the competent environmental protection department under the State Council for examination and approval in consultation with the relevant departments at the same level.

Article 35 If a unit using radioisotopes needs to transfer radioisotopes to other provinces, autonomous regions or municipalities directly under the Central Government for use, it shall, within 10 days before the implementation of the activity, file a copy of the license with the provincial environmental protection authorities in the place of use, and transfer a written report to the provincial environmental protection authorities in the place of use, and accept the application. Supervision and management of land environmental protection authorities.

The contents of the written report shall include the nuclides, activity, time and place of transfer of the radioactive isotope, the person in charge of radiation safety and the contact telephone, etc. The label and code of the radioactive source shall also be provided for the transfer of the radioactive source.

Within 20 days after the end of the activity, the user unit shall go to the provincial environmental protection authority in the place of use to go through the formalities of filing and cancellation, and notify the provincial environmental protection authority in the place of removal in writing.

Chapter IV Supervision and Management

Article 36 A radiation work unit shall engage in the production, sale and use of radioactive isotopes and radiation devices in accordance with the provisions of the license.

It is prohibited 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.

Article 37 Units producing radioisotopes and radiological devices shall set up obvious radiological markers and warning instructions in Chinese on packaging containers, equipment containing radioisotopes and radiological devices of radioisotopes; if radiological markers can be set on radioactive sources, they shall be set up together.

Instructions for equipment containing radioactive sources shall inform users that the equipment contains radioactive sources and their related technical parameters and structural characteristics, as well as the potential radiation hazards of radioactive sources and corresponding safety measures.

Article 38 Units producing and importing radioactive sources shall sign contracts for the return of waste radioactive sources when they sell Category I, II and III radioactive sources.

Units using Class I, Class II and Class III radioactive sources shall return the spent radioactive sources to the production units or to the original exporters within three months after they are idle or abandoned in accordance with the provisions of the contract for the return of the spent radioactive sources. 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 category IV and V radioactive sources shall, in accordance with the regulations of the competent environmental protection department under the State Council, pack and prepare the spent radioactive sources within three months after they are idle or abandoned and send them to the centralized storage units with corresponding qualifications for storage.

Units using radioactive sources shall, within 20 days of the completion of the activities of returning, returning or delivering spent radioactive sources, file with the provincial environmental protection authorities where they are located.

Article 39 Units that sell or use radioactive sources that have been stored before the implementation of these Measures shall, within one year from the date of implementation of these Measures, return the waste radioactive sources to the production unit or the original exporter, or to the centralized storage unit of radioactive waste with corresponding qualifications.

Article 40 The places where radioactive isotopes are produced, the places where radioactive isotopes are sold and used that produce radioactive pollution, and the radioactive devices and places where radioactive pollution is produced shall be decommissioned according to law after the end of operation. After retirement, the radiation work unit concerned may apply for the formalities of change or cancellation of the license.

Article 41 A radiation work unit shall establish a radioisotope and radiological device account, which shall record the name, time and activity, label, code, source and direction of radioisotopes, as well as the name, type, type, use, source and direction of radioisotopes.

Radioisotopes and radiological devices, personal dosage files and occupational health surveillance files should be kept for a long time.

Article 42 A radiation work unit shall prepare an annual assessment report on the safety and protection of radioactive isotopes and radiation installations and report it to the original issuing authority before January 31 each year.

The annual assessment report shall include the accounts of radioisotopes and radiological devices, the operation and maintenance of radiation safety and protection facilities, the establishment and implementation of radiation safety and protection systems and measures, accidents and emergencies, and archives management, etc.

Article 43 The competent environmental protection authorities of the people's governments at or above the county level shall supervise and inspect the radiation work units. For existing problems, they shall put forward written on-site inspection opinions and rectification requirements, which shall be signed by the inspectors or sealed by the inspecting units and submitted to the inspected units for archival filing.

Article 44 The competent provincial environmental protection authorities shall prepare annual summary reports on the supervision and management of radiation work units.

Report to the competent department of environmental protection under the State Council before March 1, 2001.

The contents of the report shall include the number and types of radiation work units, radiation sources, radiation devices, and licensing.

Issue and cancellation, accident and its handling, supervision, inspection and punishment, etc.

Chapter V Penalty Provisions

Article 45 If a radiation work unit violates the relevant provisions of these Measures and 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, it shall be fined not less than 10,000 yuan but not more than 30,000 yuan:

(1) failing to inform the user in the instruction for equipment containing radioactive sources that the equipment contains radioactive sources;

(2) Units that sell or use radioactive sources fail to return, return or deliver the spent radioactive sources stored in them to the relevant units within one year from the date of implementation of these Measures.

In violation of other provisions of these Measures, radiation work units shall be punished in accordance with the provisions of the Law of the People's Republic of China on the Prevention and Control of Radioactive Pollution, the Regulations on the Safety and Protection of Radioactive Isotopes and Radioactive Devices and other relevant laws and regulations.

Chapter VI Supplementary Provisions

Article 46 The competent environmental protection authorities of the people's governments at or above the provincial level shall issue certification documents in accordance with the Basic Standards for the Protection of Ionizing Radiation and the Safety of Radiation Sources (GB18871-2002) and the relevant provisions of the State for exemptions from the administration of radioactive isotopes and radiation devices.

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