Application and issuance of permits
Article 7 Before applying for permission, the radiation work unit shall organize the preparation or completion of environmental impact assessment documents, and submit them to the competent department of environmental protection for examination and 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 compiled by an institution with corresponding environmental impact assessment qualifications.
Eighth 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.
The activities of transferring radioisotopes and radiation devices do not require the preparation of environmental impact assessment documents.
Article 9 Where a radiation work unit applying for permission engages in the following activities, it shall organize the preparation of an environmental impact report:
(1) producing radioisotopes (except for preparing radiopharmaceuticals for PET);
(2) Using radioactive sources of Category I (except for medical use);
(3) selling (including building) or using ray devices of Class I..
Article 10 Where a radiation work unit applying for permission engages in the following activities, it shall organize the preparation of an environmental impact report:
(1) Preparation of radiopharmaceuticals for PET;
(2) Selling radioactive sources of Category I, II and III;
(3) Medical use of radioactive sources of Category I;
(4) Using Class II and Class III radioactive sources;
(five) the production, sale and use of Class II radiation devices.
Eleventh radiation work units that apply for permission to engage in the following activities shall fill in the environmental impact registration form:
(1) Selling or using radioactive sources of Category IV and Category V;
(two) the production, sale and use of Class III radiation devices.
Twelfth radiation work units to organize the preparation or declaration of environmental impact assessment documents, should be based on the planning and design of the production, sale and use of radioisotopes and radiation devices to evaluate the scale.
The environmental impact assessment documents mentioned in the preceding paragraph shall include the evaluation of the technical ability, radiation safety and protective measures of the radiation work units engaged in corresponding radiation activities, in addition to being compiled or filled in according to the requirements of the state on environmental impact assessment.
Thirteenth units that produce radioisotopes shall meet the following conditions when applying for a license:
(a) there is a special radiation safety and environmental protection management institution.
(2) There shall be no less than 5 technicians specialized in nuclear physics, radiochemistry, nuclear medicine and radiation protection, among whom there shall be no less than 1 person with senior titles.
Units that produce radioisotopes with a half-life of more than 60 days shall have not less than 30 professional and technical personnel mentioned in the preceding paragraph, including not less than 6 with senior titles.
(3) Personnel engaged in radiation work must undergo training and examination in radiation safety and protection professional knowledge and relevant laws and regulations, and key positions in radiation safety should be held by registered nuclear safety engineers.
(4) Having radioactive isotope production sites, production facilities, temporary storage warehouses or temporary storage equipment that are suitable for the designed production scale and meet the requirements of radiation safety and protection and physical security, and having the ownership of the production sites and facilities.
(5) There are packaging containers that meet the requirements of the state on the transportation and storage of radioactive isotopes.
(6) Having means of transport that meet the national requirements for the transport of radioisotopes, and being equipped with full-time drivers who have been driving for more than 5 years.
(seven) equipped with protective equipment and monitoring instruments suitable for radiation types and radiation levels, including personal dose measurement alarm, fixed and portable radiation monitoring, non-point source pollution monitoring, effluent monitoring and other equipment.
(eight) to establish and improve the operating rules, job responsibilities, radiation protection system, safety system, equipment maintenance system, personnel training system, ledger management system and monitoring scheme.
(nine) the establishment of accident emergency agencies, emergency plans and emergency personnel training and drills system, with the necessary emergency equipment and material preparation, with the ability to deal with accidents that are suitable for the design and production scale.
(10) Having the treatment capacity or feasible treatment scheme to ensure the discharge of radioactive waste gas, waste liquid and solid waste up to the standard.
Article 14 A radioisotope sales entity applying for a license shall meet the following conditions:
(1) There are specialized radiation safety and environmental protection management institutions, or at least 1 technicians with bachelor degree or above are in charge of radiation safety and environmental protection management.
(two) personnel engaged in radiation work must undergo training and examination of professional knowledge of radiation safety and protection and relevant laws and regulations.
(3) If it is necessary to temporarily store radioactive isotopes, there shall be temporary storage warehouses or equipment that meet the requirements of radiation safety protection and physical safety.
(4) Where radioactive isotopes need to be installed and debugged, there are installation and debugging places that meet the requirements of preventing misoperation and preventing workers and the public from accidental irradiation.
(5) Having packaging containers for storing and transporting radioactive isotopes that meet the requirements of relevant state regulations.
(6) Transport of radioactive isotopes may be carried out by means of transport that meet the requirements of the State for the transport of radioactive isotopes.
(seven) equipped with protective equipment and monitoring instruments suitable for radiation types and radiation levels, including personal dose measurement alarm, portable radiation monitor, non-point source pollution monitor and other instruments.
(eight) a sound operating rules, job responsibilities, safety system, radiation protection measures, ledger management system, personnel training plan and monitoring plan.
(nine) there are perfect emergency measures for radiation accidents.
Fifteenth units that produce and sell radiation devices shall meet the following conditions when applying for a license:
(1) There are specialized radiation safety and environmental protection management institutions, or at least 1 technicians with bachelor degree or above are in charge of radiation safety and environmental protection management.
(two) personnel engaged in radiation work must undergo training and examination of professional knowledge of radiation safety and protection and relevant laws and regulations.
(3) The production and debugging places of X-ray devices meet the safety requirements for preventing misoperation and accidental exposure of workers and the public.
(four) equipped with necessary protective equipment and monitoring instruments.
(five) a sound operating rules, job responsibilities, radiation protection measures, ledger management system, training plan and monitoring program.
(6) Emergency measures for radiation accidents.
Article 16 An entity that applies for a license to use radioisotopes and radiation devices shall meet the following conditions:
(a) the use of Class I, Class II and Class III radioactive sources and Class I and Class II radiation devices shall have a special radiation safety and environmental protection management institution, or at least 1 technicians with bachelor degree or above shall be fully responsible for radiation safety and environmental protection management; Other radiation work units shall have 1 technicians with college education or above to be responsible for radiation safety and environmental protection management full-time or part-time; According to the Catalogue of Radiation Safety Key Posts, if it is necessary to set up a radiation safety key post, the post should be held by a registered nuclear safety engineer.
(two) personnel engaged in radiation work must undergo training and examination of professional knowledge of radiation safety and protection and relevant laws and regulations.
(3) Units using radioisotopes shall have places or equipment for temporary storage of radioactive sources that meet the requirements of radiation protection and physical safety.
(4) The places where radioisotopes and radiation devices are used have safety measures to prevent misoperation and accidental exposure of workers and the public.
(five) equipped with protective equipment and monitoring instruments suitable for radiation types and radiation levels, including personal dose measurement alarm devices, radiation monitors and other instruments. Units that use unsealed radioactive materials should also install surface pollution monitors.
(six) a sound operating rules, job responsibilities, radiation protection and safety system, equipment maintenance system, radioisotope use registration system, personnel training plan, monitoring program, etc.
(seven) there are perfect emergency measures for radiation accidents.
(8) If radioactive waste gas, waste liquid and solid waste are generated, it shall also have the treatment capacity or feasible treatment scheme to ensure that the radioactive waste gas, waste liquid and solid waste meet the discharge standards.
Units that use radioisotopes and ray devices to carry out diagnosis and treatment activities shall also be equipped with quality control testing equipment, formulate corresponding quality assurance schemes and quality control testing plans, and at least 1 medical physics personnel shall be responsible for quality assurance and quality control testing.
Article 17 Radiation work units that assemble outsourced radioactive sources into equipment for sale shall apply for licenses according to the sales and use of radioisotopes.
Eighteenth radiation work units applying for permission 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 license (see annex1);
(2) The original and photocopy of the business license of an enterprise as a legal person or the original and photocopy of the certificate of a legal person of a public institution, and the ID card and photocopy of the legal representative shall be kept after verification;
(3) Approved environmental impact assessment documents;
(four) certification materials that meet the corresponding provisions of Articles 13 to 16 of these Measures;
(5) List of existing and planned new radioactive sources and radiation devices of this unit.
Article 19 When accepting an application, the competent department of environmental protection shall inform the applicant to apply for a license according to the planning and design scale of the production, sale and use of radioisotopes and radiation devices specified 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, and issue a license and make an announcement if it meets the requirements; Do not meet the conditions, notify the applicant in writing and explain the reasons.
Article 20 A license shall include the following main contents:
(a) the name, address and legal representative of the unit;
(2) Type and scope of activities;
(3) term of validity;
(4) Date of issuance 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 categories and total activities of all radioisotopes produced, sold and used by radiation work units, as well as the categories and quantities of radiation devices.
The license is divided into an original and a copy (see Annex 2 for the specific format and content), and the original and the copy have the same effect.
Twenty-first radiation work units that have obtained licenses for the production, sale and use of high-grade radioisotopes and radiation devices do not need to apply for licenses for low-grade radioisotopes and radiation devices if they are engaged in the production, sale and use of low-grade radioisotopes and radiation devices.
Article 22 Where a radiation work unit changes its name, address and legal representative, it shall, within 20 days from the date of change registration, apply to the original license-issuing organ for permission to change, and provide the following relevant materials:
(a) the license change application report;
(2) The original and photocopy of the changed Business License of Enterprise as a Legal Person or the Certificate of Institution as a Legal Person;
(3) The original and photocopy of the license.
After examination and approval by the original issuing authority, the license shall be renewed.
Twenty-third in any of the following circumstances, the holder shall re-apply for a license in accordance with the license application procedures stipulated in these Measures:
(1) Changing the type or scope of activities stipulated in the license;
(two) new construction, renovation and expansion of production, sale and use of facilities or places.
Article 24 The license is valid for 5 years. Where it is necessary to extend the validity period, an application for extension shall be submitted to the original license issuing authority 30 days before the expiration of the validity period of the license, and the following materials shall be provided:
(a) the license renewal application report;
(2) Monitoring report;
(3) Summary of radiation safety protection work within the validity period of the permit;
(4) The original and photocopy of the license.
The original issuing authority shall, from the date of accepting the application for extension, complete the examination before the expiration of the validity period of the license, and if it meets the conditions, renew the license and use the number of the original license; Do not meet the conditions, notify the applicant in writing and explain the reasons.
Article 25 Where a radiation work unit partially or completely terminates the production, sale and use of radioisotopes and radiation devices, it shall apply to the original issuing authority for partial modification or cancellation of the license, and the original issuing authority shall make modification or cancellation after verification.
Article 26 If a radiation work unit loses its license for some reason, it shall publish a report of loss reporting in local provincial newspapers in time, and apply to the original issuing authority for a replacement with the announcement within 1 month after the announcement.