(January 18, 2006 the State environmental protection administration released 31st come into force on March 1, 2006) Chapter I General provisions article I-implementation of the radioactive isotopes and radiation equipment under the regulations of safety and protective radiation safety license system, these measures are formulated.
    Article in the People's Republic of China territory of production and sales, the use of radioactive isotopes and radiation equipment unit (hereinafter "radiation"), shall, in accordance with the regulations, obtain a radiation safety permit (hereinafter the "license").
    Import, transfer of radioisotopes, radioisotope dating field tracer test, shall, in accordance with the regulations for approval.
    Export of radioactive isotopes should be in accordance with the provisions of the relevant procedures of the measures.
    Radioisotope unit transfer radioactive isotopes to other provinces, autonomous regions and municipalities, shall, in accordance with the regulations for the record.
    Radioisotope in these measures include non-sealed radioactive sources and radioactive material.
    Article based on radioactive sources and radiation-emitting devices on the degree of potential harm to human health and the environment, from high to low, radioactive sources are divided into class ⅰ, ⅱ, ⅲ, ⅳ, ⅴ-type, and radiation-emitting devices are divided into class I, class II and class III.
    Fourth production, sale and use of radioactive isotope class I sources, sales and use of class I-Ray devices of radiation work permit issued by the Environmental Protection Department under the State Council for approval.
    Radiation work permit outside of the provisions of the preceding paragraph, the people's Governments of provinces, autonomous regions and municipalities directly under the Environmental Protection Department (hereinafter "provincial environmental protection authorities") approvals issued.
    A radiation unit production and sales, uses a variety of sources, radiation-emitting devices or unsealed radioactive substances, only need to apply for a license.
    Radiation work unit needs respectively to the State Environmental Protection Department and the provincial environmental protection Department to apply for a permit, license issued by the Environmental Protection Department under the State Council for approval.
    Approval should be issued a license by the Environmental Protection Department Briefing at the public security Department, Department of health.
    Fifth people's Governments above provincial level people's Government under may entrust the competent Department of environmental protection environmental protection authorities to issue a permit.
    Sixth State Council departments in charge of environmental protection for imported under the restricted list of import and export of radioactive isotopes for approval.
    Environmental Protection Department under the State Council in accordance with the relevant Chinese laws and the provisions of international treaties and conventions concluded or acceded to handle under the restricted list of import and export formalities relating to the export of radioactive isotopes.
    Provincial environmental protection authorities responsible for approval or for the record for the following activities: (a) the transfer of radioactive isotopes (ii) transfers of radioactive isotopes to other provinces, autonomous regions and municipalities use; (c) radioisotope field tracer test, but may result in cross-border environmental impact of radioactive isotope tracer tests in the field, by the Environmental Protection Department under the State Council for approval.
    Chapter II permit applications and issuing seventh radiation work unit before the application for a permit shall prepare or complete environmental impact assessment document, and pursuant to the procedure established by the State environmental protection authorities.
    Documents for environmental impact assessment environmental impact statement or environmental impact reports should be prepared by the Agency with the appropriate qualification of environmental impact assessment.
    Article eighth, based on radioactive isotopes and radiation equipment safety and protection requirements, and their impact on the environment, classification management of environmental impact assessment document.
    Transfer of radioactive isotopes and radiation equipment activities do not require the preparation of an environmental impact assessment document.
    Nineth radiation work units engaged in the following activities of the application for a license, shall organize the preparation of environmental impact statements: (a) the production of radioisotopes (preparation of PET radiopharmaceuticals); (b) the use of class I sources (except for medical use); (iii) sale (including construction), using the I-ray device.
    Tenth Article application received license of radiation work units engaged in following activities of, should organization prepared environment effect report table: (a) preparation PET with radioactive drug of; (ii) sales ⅰ class, and II class, and III class, and IV class radiation source of; (three) medical using ⅰ class radiation source of; (four) using II class, and III class, and IV class radiation source of; (five) production, and sales, and using II class ray device of.
    11th radiation work units engaged in the following activities of the application for a permit shall fill in registration forms of environmental impact: (a) the sale, use five types of radioactive sources, (ii) the production, sale and use of class III radiation-emitting devices.
    12th radiation work organization when preparing or completing the environmental assessment file shall be in accordance with the planning and design of its radioactive isotopes and radiation equipment to evaluate the scale of the production, sale and use.
    Environmental impact assessment document referred to in the preceding paragraph, except in accordance with the relevant State environmental impact assessment requirement or completing things, should also include activities of the radiation work units engaged in radiation technology, radiation safety and protection measures for evaluation of content.
    13th production of radioisotopes application for a license, subject to the following conditions: (a) has a specific radiation safety and environmental protection management.
    (B) not less than 5 of nuclear physics, radiochemistry, nuclear medicine and radiation protection, and other related professional and technical personnel, many of which have senior professional titles in the 1.
    Production units of the half-life of radioactive isotopes is greater than 60 days, referred to in the preceding paragraph shall not be less than 30 Professional and technical personnel, many of which have senior professional titles in the 6.
    (C) workers engaged in radiation work must be radiation safety and protection training and assessment of professional knowledge and related laws and regulations, including radiation safety key position should be undertaken by certified security engineers.
    (D) production to adapt to the size and design, meet the requirements of radiation safety and protection, physical security of radioactive isotope production sites, production facilities, staging or staging equipment, and have ownership of production space and production facilities.
    (E) meet the requirements of the relevant provisions of the State transportation and storage the packing containers of radioisotopes.
    (F) meets the requirements of national radio-isotope transport carriers, and equipped with at least 5 years driving for full-time drivers.
    (VII) equipped with radiation type, and radiation level suitable protective equipment and monitoring instruments, including the measurement of personal dose alarm, fixed and portable radiation monitoring, pollution monitoring, effluent monitoring equipment on the surface.
    (H) establish operating procedures, job responsibilities, radiation protection systems, security systems, equipment maintenance, personnel training, account management and monitoring programmes.
    (IX) establishment of emergency response agencies, contingency and emergency response plan for staff training exercise system, it is necessary to prepare emergency equipment and supplies, and designed to adapt to the size of emergency handling capabilities.
    (J) ensure that radioactive waste gas, waste water, solid waste discharge processing capabilities or feasible solutions.
    14th sale radioisotope unit application for a license, subject to the following conditions: (a) has a specific radiation safety and environmental protection management organization, or at least 1 with Bachelor degree technical personnel specializing in radiation safety and environmental protection management.
    (B) workers engaged in radiation work must be radiation safety and protection training and assessment of professional knowledge and related laws and regulations.
    (C) require staging of radioisotopes, meet radiation safety and protection, physical security requirements of staging or equipment.
    (D) require installation and commissioning of radioactive isotopes, meet to prevent wrong operation, preventing staff and public exposure to unexpected requirements installation sites.
    (E) meet the requirements of the relevant provisions of the state storage container, transport packaging of radioactive isotopes.
    (Vi) transport of radioisotopes can be used with country radio-isotope transport requirements of transport.
    (VII) equipped with radiation type, and radiation level suitable protective equipment and monitoring instruments, including measurement of personal dose alarm, portable radiation monitor, surface contamination monitoring instruments.
    (H) has a sound operating procedures, job responsibilities, security system, radiation protection measures, account management system, personnel training and monitoring programmes.
    (I) comprehensive nuclear contingency measures.
    15th production and sales units of radiation-emitting devices application for a license, subject to the following conditions: (a) has a specific radiation safety and environmental protection management organization, or at least 1 with Bachelor degree technical personnel specializing in radiation safety and environmental protection management.
    (B) workers engaged in radiation work must be radiation safety and protection training and assessment of professional knowledge and related laws and regulations.
    (C) radiation equipment production, debugging, place to meet to prevent wrong operation, preventing the accidental exposure of staff and the public safety requirements.
    (D) are equipped with the necessary protective equipment and monitoring instruments.
    (E) has a sound operating procedures, job responsibilities, radiation protection measures, account management systems, training plans and monitoring programs.
    (F) nuclear contingency measures. 16th using the radioactive isotope, radiation equipment unit application for a license, subject to the following conditions: (a) the use of class I, class II and class III radioactive sources, class ⅰ and ⅱ using radiation-emitting devices, should be provided with specialized radiation safety and environmental protection agency, or at least 1 with Bachelor degree technical personnel specializing in radiation safety and environmental protection management And other radiation work unit 1 should have a college education technician full-time or part-time responsible for radiation safety and environmental protection management according to radiation safety directory of key positions, radiation safety shall be established in key positions, the positions should be undertaken by certified security engineers.

    (B) workers engaged in radiation work must be radiation safety and protection training and assessment of professional knowledge and related laws and regulations.
    (C) the use of radioisotopes unit shall meet the radiation protection of radioactive sources and the entity defence requirements temporary Gallery or device.
    (D) radioactive isotopes and radiation equipment used to prevent wrong operation, preventing the accidental exposure of staff and the public safety measures. (E) equipped with radiation type, and radiation level suitable protective equipment and monitoring instruments, including the measurement of personal dose alarm, radiation monitoring instruments.
    Units also use of unsealed radioactive substances shall have surface contamination monitors.
    (F) has a sound operating procedures, job responsibilities, radiation protection and the safety and security systems, equipment repair and maintenance systems, radioisotope used registration systems, training plans, monitoring programmes and so on.
    (G) comprehensive nuclear contingency measures.
    (H) radioactive waste gas, liquid and solid wastes generated, should also have to ensure that radioactive waste gas, waste water, solid waste discharge processing capabilities or feasible solutions.
    Use of radioactive isotopes and radiation equipment for diagnosis and treatment units, should also be equipped with quality control testing equipment, to develop appropriate quality assurance program and quality control testing, and at least one medical physics is responsible for quality assurance and quality control testing.
    Article 17th will purchase the radiation source Assembly in equipment sales of radiation units, according to the sale and use of radioisotopes application for a license.
    18th article application received license of radiation work units should to has approval right of environmental protection competent sector submitted following material: (a) radiation security license application table (see annex a); (ii) enterprise corporate license are, and copy or institutions corporate certificate are, and copy and the statutory representative people ID original and copies, testing Hou retained copies; (three) by approval of environment effect evaluation file; (four) meet this approach 13th article to 16th article corresponding provides of proved material;
    (E) existing and proposed new sources of radiation and radiation-emitting devices list.
    19th environmental protection authorities at the time of acceptance of the application, it shall inform the applicant in accordance with the environmental impact assessment documentation described in radioactive isotopes and radiation equipment planning and design of the production, sale and use of scale permit.
    The competent Department of environmental protection shall be completed within 20 working days from the date of acceptance of the application review, qualified, licensed and announce it; do not meet the conditions, and notify the applicant in writing and state the reasons.
    20th license includes the following main elements: (a) the name, address, legal representative; (b) the type and scope of the activities engaged in by (iii) expiry date; (d) date of issuance, and certificate number.
    Permit activity in production, sale and use of three categories of species; activities refers to the radiation work unit production and sales, all the radioactive isotopes used category, overall volume of activity and the type of radiation-emitting devices,.
    License includes an original and a copy (specific format and content, see annex II), have the same effect.
    Article 21st production, sale and use of higher category radioactive isotopes and radiation equipment the radiation work permit unit, engaged in low-level radioactive isotopes and radiation equipment production, sales, use, activity, and do not need to apply for a separate permit low-level radioactive isotopes and radiation equipment.
    22nd article radiation work units change units name, and address and statutory representative people of, should since change registration of day up 20th within, to original sent card organ application handle license change procedures, and provides following about material: (a) license change application report; (ii) change Hou of enterprise corporate license or institutions corporate certificate are, and copy copies; (three) license are, and copy.
    After the original issuing authority for examination and approval, renewal of license.
    Article 23rd, one of the following circumstances, certified unit shall, in accordance with the provisions of these measures permit application procedures, reapply for the permit: (a) the change permits the type or scope of activities; (b) the construction or reconstruction, expansion of production, sale and use of facilities or places. Article 24th license is valid for 5 years.
    Expiry, needs continuity, it should be before the license expires 30th lodge renewal application to the issuing authority, and provide the following information: (a) the license renewal application reports; (b) the monitoring report (iii) licence is valid within the radiation protection work; (d) license and duplicate copies.
    Original issuing authorities shall from the date of accepting an application for continuation, completed before the expiry of the permit review, eligible, continue and renew license, and use the original license number; do not meet the conditions, and notify the applicant in writing and state the reasons.
    25th radiation work unit terminate part or all terminated production, sale and use of radioactive isotopes and radiation equipment activities, should be submitted to the issuing authority part of the change or cancellation of permit applications, the original issuing authority after verification of qualified, change or cancellation of the license.
    26th radiation work due to loss of permits, shall promptly lost notice is published to the provincial press and announcement within a month after the 30th announcement to the original certificate reissued. Chapter III import, export, transfer, transfer of approval and for the record the 27th article import under the restricted list of import and export of radioactive isotopes, shall, before importing the Environmental Protection Department for approval; approved, by the competent foreign trade Department under the State Council according to the relevant provisions of the foreign trade issued import permits.
    Environmental Protection Department under the State Council in approving the import of radioactive sources when given radioactive source code.
    Unsealed radioactive substances imported in batches of units shall be reported to the Environmental Protection Department under the State Council for approval once every 6 months.
    28th article application imports included limit import and export directory of radioactive isotope of units, should to State environmental protection competent sector submitted radioisotope imports approval table, and submitted following material: (a) imports units license copies; (ii) radioisotope using expires Hou of processing programme, which, imports ⅰ class, and II class, and III class radiation source of, should provides original export party is responsible for from eventually user recycling radiation source of commitment file copies; (Three) imports radiation source of clear label and necessary of description file of copies or copies, which, ⅰ class, and II class, and III class radiation source of label should engraving in radiation source ontology or sealed package shell body Shang, IV class, and v class radiation source of label should records in corresponding description file in the; (four) imports units and original export party Zhijian signed of effective agreement copies; (five) will imports of radioactive isotope sales to other units using of, also should provides and using units signed of effective agreement copies,
    And the use of copies of licenses.
    Radioactive isotope imports form the specific format and content see annex III.
    29th Environmental Protection Department under the State Council shall accept an application for radioactive isotope imports within 10 working days from the date of completion of the review, eligible, be approved; not eligible, inform the applicant in writing and state the reasons.
    Importers and users shall, on the date of the import activity within 20th respectively approved imports of radioactive isotope form submitted to their respective provincial environmental protection authorities.
    Article 30th units under the restricted list of import and export of radioactive isotopes, radioisotopes exported shall be submitted to the Environmental Protection Department form, and submit the following materials: (a) the copy of the export permit; (b) the importing Parties can legally hold a radioactive isotope of either Chinese or English documents; (c) the exporter and the foreign importer signed a copy of valid agreements.
    RI export specific format and content of the table in annex IV.
    Export unit shall, from the date of completion of the export activities in the 20th, radioactive isotope exit list submitted to the seat of the provincial environmental protection authorities.
    Export radioisotope unit shall comply with the relevant provisions of national trade.
    Article 31st of radioisotopes, into the unit before each transfer should be reported to the provincial environmental protection authorities for review and approval.
    Transfer in batches of unsealed radioactive substances, transferred to the unit every 6 month report the provincial environmental protection authorities for review and approval. Radioactive isotopes can only transfer between licensed units.
    Prohibited without license or beyond the permit type and scope of the transfer of radioactive isotopes.
    Unauthorised transfer of radioactive isotopes.
    Article 32nd transferred to the unit shall, prior to the transfer of radioisotopes to the provincial environmental protection Department of radioisotope transfer form, and submit the following materials: (a) the license transfer, transferred to the unit, (ii) radioactive isotope used solutions after the expiration and (iii) transfer transfer agreement signed by both parties.
    Radioisotope transfer form the specific format and content see annex v.
    The competent Department of environmental protection shall be completed within 15 working days from the date of acceptance of the application review, eligible, be approved; not eligible, inform the applicant in writing and state the reasons.
    Article 33rd, transferred out of the radioisotope unit shall, on the date of the transfer of activities within 20th, respectively, the transfer of a radioisotope form submitted to their respective provincial environmental protection authorities. Article 34th radioisotope tracer tests are carried out in the field unit, shall, before each test to prepare environmental impact reports and pilot provincial environmental protection authorities can be examined and approved by the departments concerned at the rear.

    Field tracer test of radioactive isotopes likely to contribute to cross-border environmental impacts, environmental impact reports should be submitted to the State Council departments concerned at the Department of environmental protection for review and approval.
    35th radioisotope unit needs to transfer the radioactive isotopes to other provinces, autonomous regions and municipalities use, activities should be implemented in the 10th before a copy of the license to use the provincial environmental protection departments, reports out of the provincial environmental protection authorities in writing, and to accept supervision and management departments in charge of environmental protection.
    Content of the written report should include the radioactive nuclides, activity, time, and location, radiation safety officer and contact phone number and other information; transferring radioactive sources sources should also be provided of the marking and coding.
    Units should be used at the end of the event in the 20th to provincial environmental protection authorities for the record the cancellation procedures, and writing out of the provincial environmental protection authorities.
    Supervision and administration of the fourth chapter 36th radiation work shall, in accordance with the provisions of the license radioactive isotopes and radiation equipment production, sale and use of activity.
    Prohibited without a permit, or not in accordance with licence types and scope in production, sales and use of radioactive isotopes and radiation equipment activity.
    37th production of radioisotopes and radiation-emitting devices, should be containers of radioactive isotopes, radioactive isotope-containing devices and radiation-emitting devices, on clear identification of the radioactive and warning specifications in Chinese; radiation labels can be set on the source, should be set up.
    Devices containing radioactive source instruction shall inform the user of the equipment containing radioactive sources and other technical parameters and structural characteristics, and informed sources of potential radiation hazards and appropriate safety precautions.
    38th production units in sales, import of radioactive sources class I, class II and class III radioactive sources, and the use of radiation sources of waste radioactive source back to contract signed. Use of class I, class II, class III radioactive source units should be stipulated in the contract is returned in waste radioactive sources, radioactive sources, idle or abandoned waste radioactive sources within 3 months after the return to production units or return to the exporting Party.
    Production units or return cannot be returned to the exporter, and sent to the appropriate storage of radioactive waste storage units.
    Type ⅳ and type ⅴ radioactive source units should be in accordance with the provisions of the Environmental Protection Department under the State Council, radioactive sources, idle or abandoned within 3 months after the waste package after conditioning of radioactive sources could be circulated to qualified store radioactive waste storage units.
    Units using radioactive sources should be discarded radioactive source returned, return or date of the send activity within 20th, to the local environmental protection departments at the provincial level.
    39th sales units, the use of radioactive sources in the scrap before the implementation of these measures has to be stored radioactive sources, since the implementation of the measures for returning the radioactive sources within 1 year from the date of production units or return the original export delivered to him, or a corresponding qualification of the radioactive waste storage units. 40th production place of radioactive isotope, radioactive pollution, radioactive isotope sales and use radiation-emitting devices, radioactive pollution and its sites, according to law, should be decommissioned after the end run.
    Decommissioning is completed, about radiation work units before they can apply for a license change or cancellation procedures.
    41st radiation work units shall establish a radioactive isotopes and radiation equipment account, recording name of radioactive nuclides, shipped and activity, and marking, coding, source and destination, the name, type, and radiation-emitting devices-Ray category, type, purpose, origin and destination of such matters.
    Radioactive isotopes and radiation equipment account, personal dose records and occupational health surveillance archives shall be long-term preservation.
    42nd in radiation work unit should prepare radioisotopes and radiation-emitting devices annual assessment of the State of security and protection, before January 31 of each year the original Licensing Office.
    Annual assessment report should include radioactive isotopes and radiation equipment account, radiation safety and protection facilities operation and maintenance, radiological safety and protection systems and measures established and implemented, accident and emergency, and records management content.
    Article 43rd departments of local environmental protection authorities above the county level shall supervise and inspect the unit for radiation work, existing problem, it shall submit a written request on-site inspection and rectification of, and signed by the inspector or inspection units and sealed units inspected, and archived by the check unit for filing.
    44th provincial environmental protection authorities should prepare annual summary report of the supervision and management of radiation work units, before March 1 of each year, the Environmental Protection Department.
    Reports should include radiation units quantity, number and types of radioactive sources, radiation device number and type of permit issuance and cancellation, accident and its treatment, supervision and punishment, and so on. Fifth chapter penalty is 45th article radiation work units violation this approach of about provides, has following behavior one of of, by County above government environmental protection competent sector ordered stop violations, deadline corrected; late not corrected of, at 10,000 yuan above 30,000 yuan following of fine: (a) not in containing radiation source equipment of manual in the told user the equipment contains radiation source of; (ii) sales, and using radiation source of units not in this approach implementation of day up 1 years within will its storage of waste radiation source make back, and
    Returned or sent to the relevant units.
    Radiation work in violation of other provisions of the present measures, in accordance with the People's Republic of China on prevention and control of radioactive pollution, and radioactive isotopes and radiation equipment safety and protection regulations and other relevant laws and regulations for penalties.
    Sixth chapter supplementary articles article 46th provincial people's Government above the Department of environmental protection in accordance with the protection from ionizing radiation and basic standards for the safety of radiation sources (GB18871-2002) and relevant regulations of the State is in charge of radioactive isotopes and radiation equipment exemption certificate file management.
  47th article of the rules take effect on March 1, 2006.