THE MINISTRY OF SCIENCE AND TECHNOLOGY
SOCIALIST REPBLIC OF VIETNAM
Hanoi, January 11th , 2006
GUIDES ON DECLARATION AND AUTHORIZATION ISSUANCE OF RADIATION-RELATED PRACTICE
Pursuant to the Decree No. 50/1998/NĐ-CP issued by the Government on the 16th July 1998, providing details for the implementation of the Ordinance on Radiation Safety and Control;
Pursuant to the Decree No. 54/2003/NĐ-CP issued by the Government on the 19th May 2003, regulating the functions, responsibilities, authorities and organizational structure of the Ministry of Science and Technology and the Decree No. 28/2004/NĐ-CP issued by the Government on the 16th January 2003, amending and supplementing some of the provisions of the Decree No 54/2003/NĐ-CP issued on the May 19th, 2003;
The Ministry of Science and Technology issues the following guides on radiation related practice declaration and authorization issuance:
I. SUBJECTS AND SCOPE OF APPLICATION
1. This Circular provides guides on the following:
a) Declaration of radiation facilities, radioactive sources and radioactive wastes;
b) Issuance of registrations for radioactive sources and radioactive waste storage;
c) Issuance of licenses for operating radiation facilities, conducting radiation activities, and specified radiation workers;
d) Issuance of licenses for upgrading and expanding scales and operation of radiation facilities and for upgrading radiation equipment;
dd) Issuance of licenses for conducting radiation safety services
2. The Circular will not be applied to:
a) Unknown-owners’ radioactive sources and radioactive wastes;
b) Nuclear reactor operation
c) Activities relating to nuclear fuel cycle (excluding the exploration and processing of uranium, thorium ores and other research and development activities relating to nuclear fuel cycle);
d) Radiation practices exempted from declaration and authorization application as defined in Vietnam Standard TCVN 6870:2001 Radiation safety exemption of declaration, registration and licensing and other relevant legal regulations.
3. The license for operation of radiation facilities issued in accordance with this Circular shall be specialized in the field of radiation safety and shall not replace other licenses specified by the law.
Organizations and individuals who possess radiation facilities, radioactive sources, and radioactive wastes must submit a declaration to the regulatory authority.
Organizations and individuals who possess radioactive sources and radioactive waste storage must apply for registration of radioactive sources and radioactive waste storage with the regulatory authority.
IV. LICENSES FOR OPERATING RADIATION FACILITIES
Organizations and individuals who possess radiation facilities must apply for radiation operation license.
Radiation facilities must comply with their radiation practice specified in the license.
V. LICENSES FOR CONDUCTING RADIATION ACTIVITIES
Radiation facilities must apply for supplementary licenses if conducting radiation practices that are not specified in the authorized licenses (except for those that are specified in Section XIII, Chapter II).
Facilities that do not possess radiation operation licenses must apply for licenses for conducting radiation activities if the activities are considered not to be frequent.
A license of conducting radiation work can be issued for one or more radiation activities.
VI. LICENSES FOR SPECIAL RADIATION WORKERS
Those who carry out the following activities must apply for special radiation worker’s licenses:
1. Assembling and operating nuclear reactors, accelerators, radiographic machines, industrial and semi-industrial irradiation equipment, industrial photographic machines, and repairing their malfunctions ;
2. Producing radioactive isotopes
3. Conducting radioactive decontamination and remediation of radiation incidents of level 2 and higher, as specified in Article 18 of the Decree 50/1998/NĐ-CP issued by the Government on the 16th July 1998 detailing the implementation of the Ordinance on Radiation Safety and Control (hereinafter called Decree 50/1998/NĐ-CP)
VII. LICENSES FOR UPGRADING, EXPANDING SCALES AND OPERATION OF RADIATION FACILITIES AND UPGRADING RADIATION EQUIPMENT
A radiation facility, before upgrading or expanding its scale and operation prescribed in the operation license, or upgrading radiation equipment prescribed in the registration, must apply for the license of radiation facility upgradation and scale expansion or equipment upgradation.
After finishing the work, the radiation facility shall apply for a new or amended license.
VIII. LICENSES FOR RADIATION SAFETY SERVICES
Agencies who provide services on personal dose measurements, radiation inspection/check, and equipment calibration must apply for radiation safety service license.
IX. REGULATORY AUTHORITIES RESPONSIBLE FOR CONFIRMING DECLARATION, ISSUING REGISTRATIONS AND LICENSES
1. The Ministry of Science and Technology is responsible for confirming declaration, and issuing registrations and licenses for radiation safety operation of all types, except for those specified in the following item 2.
2. Provincial Departments of Science and Technology are responsible for confirming declaration, and issuing registrations and licenses for medical X-ray equipment as specified in this Circular.
X. Charges and fees
Organizations and individuals who apply for registrations, licenses, renewal, and amendment shall pay for charges and fees as specified by laws. The charges and fees will be determined relatively to the code of radiation sources and radiation practices prescribed in Appendix I and II to this Circular.
PROVISIONS ON DECLARATION, AND REGISTRATION, LICENSES APPLICATION
I. PROCEDURE FOR DECLARATION
1. Within seven working days of possessing a facility, radiation sources or radioactive wastes, organizations and/or individuals must provide the Regulatory
Authority with a declaration using the declaration forms in Annex 4 to this Circular (declaration forms 10/ATBX-CP, 13/ATBX-CP, 15/ATBX-CP, respectively).
2. If organizations and/or individuals are applying for registration or license issuance during the above specified period, declaration will not be required.
II. PROCEDURE FOR REGISTRATION APPLICATION
1. Within thirty days of possessing radiation sources or radioactive waste storage site, organizations and/or individuals must lodge their registration applications to the Regulatory Authority.
2. The registration application shall comprise of:
a) An application using form No. 01/ATBX-CP as in Annex 3 to this Circular;
b) A radiation sources declaration using form No. 13/ATBX-CP as in Annex 4 to this Circular;
c) A copy of the radiation sources record; if the record of radiation sources is lost or unattainable, organizations and/or individuals must determine the source activity, radioactive isotopes and technical specifications of the equipment;
d) Technical documents on radiation sources storage site (technical drawings with designers’ signature); an evaluation of radiation background in the surroundings of the site; measures for radioactive source security and safety.
3. The registration application for radioactive waste storage site shall comprise of:
a) An application using form No. 01/ATBX-CP as in Annex 3 to this Circular;
b) A declaration of the site using form No. 14/ATBX-CP as in Annex 4 to this Circular;
c) A description of the origin of the radioactive waste, the activity of the radioactive waste; technical documents of radiation sources storage site (technical drawings with designers’ signature), an evaluation of radiation background in the surroundings of the site; measures for radiation source security and safety.
4. If organizations and/or individuals are applying for registration and license at the same time within the above specified period, only the registration application (form No. 01/ATBX-CP) and the documents needed for license application are required.
III. DOCUMENTS REQUIRED FOR FACILITY OPERATION LICENSE APPLICATION
The application for facility operation license shall comprise of:
1. An application using form No. 02/ATBX-CP as in Annex 3 to this Circular;
2. A facility declaration using form No. 10/ATBX-CP as in Annex 4 to this Circular;
3. A radiation officer registration using form No. 11/ATBX-CP as in Annex 4 to this Circular;
4. A radiation worker registration using form No. 12/ATBX-CP as in Annex 4 to this Circular;
5. A declaration of radiation sources using form No. 13/ATBX-CP as in Annex 4 to this Circular;
6. A declaration of radiation sources storage location using form No. 14/ATBX-CP as in Annex 4 to this Circular;
7. A declaration of radioactive wastes using form No. 15/ATBX-CP as in Annex 4 to this Circular;
8. An evaluation of radiation safety with the content specified in Section VII, Chapter II of this Circular;
9. Copies of following documents:
a) The authority’s decision on the facility establishment or business license;
b) Reports on construction verification and approval for rooms containing radiation sources and radiation equipments, and shielding design for these rooms.
c) Reports on construction verification and approval for radioactive waste store and the radioactive waste storage site;
d) The registration of the radiation sources (if any);
dd) The registration of the radioactive waste storage site (if any);
e) A copy of the radiation sources record; if the record is lost or unattainable, organizations and/or individuals must determine the source activity, radioactive isotopes and technical specifications of the equipment;
g) Copies of manuals for using, testing and maintaining the radiation sources provided by the manufacturers or suppliers (if any); and copies of the certificates of the radiation sources and radiation equipment;
h) The decision on radiation officer appointment; the radiation officer’s certificate on radiation safety granted by an organization who is authorized by Ministry of Science and Technology to provide training on radiation safety;
i) Radiation workers’ certificates on radiation safety (if any), and professional certificates of the radiation workers;
k) The personal dose service contract with an organization who is assigned by the Regulatory Authority on behalf of the Ministry of Science and Technology;
l) Radiation workers’ licenses for conducting special practices (for facilities that conduct special practices);
A facility who does not possess radiation sources will not have to comply with the provisions specified in Item 5 and Item 9 b, d, f, h of this Article.
A facility who does not possess radioactive wastes will not have to comply with provisions specified in Items 6, 7, and Item 9 c, e of this Article.
IV. DOCUMENTS REQUIRED FOR APPLICATION OF LICENSE FOR CONDUCTING RADIATION PRACTICES
The application for a license of conducting radiation practices shall comprise of:
1. An application using form No. 02/ATBX-CP as in Annex 3 to this Circular;
2. A declaration of radiation sources using form No. 13/ATBX-CP as in the Annex 4 to this Circular, except for those practices that do not involve radiation sources;
3. A declaration of radioactive waste storage site using form No. 14/ATBX-CP as in the Annex 4 to this Circular, except for those that do not produce radioactive wastes;
4. An evaluation of radiation safety with the content specified in Section VII, Chapter II of this Circular (supplementary practices evaluation);
5. Documents specified in Item 9, Section III, Chapter II of this Circular (except for those that have submitted when applying for radiation facility operation license).
V. DOCUMENTS REQUIRED FOR APPLICATION OF LICENSE FOR UPGRADING, EXPANDING SCALES AND OPERATION OF RADIATION FACILITIES AND UPGRADING RADIATION EQUIPMENT
1. An application using form 04/ATBX-CP as in Annex 3 to this Circular.
2. Proposal for upgrading, expanding the scale and operation (or upgrading radiation equipment);
3. Justification for radiation safety;
4. An evaluation on environmental impact relating to radiation safety as the facility or the equipment is in operation.
VI. DOCUMENTS REQUIRED FOR APPLICATION OF LICENSE FOR RADIATION SAFETY SERVICES
1. An application using form 05/ATBX-CP as in Annex 3 to this Circular.
2. The list of workers who conduct radiation safety service activities, including their professional certificates that should be appropriate to their work;
3. A list of dosimeters, calibration equipment, and copies of their standards certifications of ;
4. A safety evaluation on service procedures;
5. A copy of the facility’s regulations on quality assurance and quality control;
6. Service results form.
A facility that provides radiation safety services and possesses radiation source(s) must apply for a radiation facility license.
VII. RADIATION SAFETY ASSESSMENT CONTENT
1. A radiation safety assessment shall include the followings:
a) Justification for undertaking the radiation practice;
b) Technical parameters and the record of radiation sources or certificates of the radiation sources issued by the manufacturer.
c) Procedures of using, testing, maintaining the radiation source;
d) Calibration data (for radiation equipment);
dd) Shielding design;
e) Methods for radiation source clearance or disposal;
g) Measures to ensure the safety and security of the radiation sources and radioactive wastes;
h) List of radiation alarming equipment and their technical features;
i) List of dosimeters, and their technical features;
k) Evaluation of the radiation background;
l Measures to ensure the safety of radiation workers and the public;
m) Evaluation on the environmental impact regarding radiation safety;
n) Human resource, including the radiation facility manager, radiation safety officer, radiation workers, and workers conducting special radiation practices (if any);
o) Working procedure and regulations on radiation safety;
p) Emergency response plan;
q) The financial resource, including the budget available for radiation safety measures and radiation accident response.
2. In addition to those specified in Item 1 of this Section, for the specific activities as below, the radiation safety assessment shall include the following complementary information:
a) Use of radiation sources in medicine: An assessment of radiation safety for patients who undergo radiation treatment or diagnosis; a quality verification of the radiation equipment issued by a radiation service facility licensed by the Ministry of Science and Technology;
b) Radiation specialization research and training activities involving radiation sources: an assessment of radiation safety for researchers, trainers and trainees;
c) Production of consumer products containing radioactive materials: an evaluation of radiation safety for consumers; technical features of the warehouse for the products and an evaluation of the radiation background in the surroundings of the warehouse.
d) Mining and processing radioactive ores and minerals: mining and processing flowsheets; a safety assessment of the mining and processing technologies; the amount of ores processed and the amount of wastes generated; radionuclides and their contents in the ore and waste;
dd) Producing radioactive sources and manufacturing, assembling radiation equipment: a description of the design and process of producing, manufacturing the radiation source, radiation source quality testing methods (accompanied with technical drawings, signatures of the designer and drawer), methods for radioactive waste treatment (if any); source design approval certificates issued by the competent authority of the country of the origin;
e) Radioactive waste treatment activities: a description of the procedure for radioactive waste treatment, the amount of the radioactive waste treated and stored; radionuclides and their contents in the radioactive waste, a safety assessment of the radioactive waste treatment technology;
g) Radiation source repairing and replacing services : specifications of equipment used for repairing or replacing radiation sources, dosimeters and copies of certificates of their standard, calibration equipment; a safety assessment of repairing, replacing procedures ; the service facility’s regulations on quality assurance and control;
h) Radiation source transfer: an assessment of the transferring facility’s and receiving facility’s capacities; transport and storage conditions; the transfer contract;
i) Radiation source import and export: an assessment of the capacity of the facility receiving or possessing the radiation sources; import, export, transport and storage conditions; the certificates of the radiation sources issued by the manufacturer and the competent authority of the country of the origin, instruction manual for using and maintaining the radiation source (for unsealed sources or sealed sources of a half-life of less than 6 months, a certificate is not required for application for import but required to be submitted to the Regulatory Authority after the sources have been imported; the contract for import, export entrustment (if any) together with a copy of the business license of the import, export service facility ;
k) Transiting radiation sources: a safety assessment of transit, transport, storage conditions; transit contracts;
l) Radiation practices involving transporting radiation sources or radioactive wastes: a description of the transport process, a safety assessment of the transport conditions specified in Circular No. 14/2003/TT-BKHCN dated 11 June, 2003 on Safety guides for transport of radioactive materials.
3. Safety assessment forms for specific radiation facilities and radiation practices shall be specified by the Agency for Radiation and Nuclear Safety and Control.
VIII. DOCUMENTS REQUIRED FOR APPLICATION OF LICENSE FOR SPECIAL RADIATION WORKERS
The application for special radiation workers shall comprise of:
1. An application using form 06/ATBX-CP as in Annex 3 to this Circular;
2. A radiation worker registration using form 12/ATBX-CP as in Annex 4 to this Circular;
3. Copies of certificates on radiation safety granted by an organization authorized by the Ministry of Science and Technology.
4. Copies of other certificates, diplomas, degrees, qualifications
5. Health certificates by a medical facility at district level or higher.
IX. GENERAL REQUIREMENTS FOR DECLARATION, AND REGISTRATION, LICENSE ISSUANCE
1. Organizations, individuals who submit declaration or apply for registration and license issuance shall submit 02 sets of the application documents to the Regulatory Authority as specified in this Circular.
2. All the information in the application must be true. Any document written in foreign languages (except for English) must be translated into Vietnamese. The copy and translation versions must be certified by the applying organizations/individuals.
3. The application documents shall be in an envelop and sent directly to the Regulatory Authority office or by post. Facsimile will not be accepted.
X. CONDITIONS FOR DECLARATION, REGISTRATION AND LICENSE APPLICATION
Registration and licenses are issued only when the following conditions are met:
1. All the documents specified in this Circular are submitted;
2. All the requirements for radiation safety as stipulated in law are met;
3. Radiation safety assessment cost and registration and licensing fees are paid in accordance with the law.
XI. DURATION OF VALID REGISTRATION AND LICENSE
1. The registration or license is valid until the Regulatory Authority verifies that the radiation source or the storage location for radioactive wastes is met all the requirements and criteria for exemption or the radiation source and the location for radioactive storage can be transferred to another organization/individual.
The receiving organization/individual shall bear the responsibility to apply for a new registration or license.
2. The license duration is specified in the Decree 50/1998/ND-CP issued by the Government on the 16th July 1998 as follows:
a) The license of radiation facilities possessing accelerators, irradiation equipment is valid up to 5 years;
b) The operation license of other facilities is valid up to 3 years;
c) The license for special radiation workers is valid up to 3 years;
d) The license for radiation practices can be valid for various durations, depending on the types of work, but not more than 3 years.
XII. LICENSE RENEWAL
1. 60 days before the license expire, the licensee shall apply for a renewal. Otherwise, the licensee must apply for a new license.
2. Documents required for license renewal shall comprise of:
a) A renewal application using form 07/ATBX-CP as in Annex 3 to this Circular;
b) A report on changes;
c) A report on radiation safety;
d) A copy of the current license.
XIII. LICENSE AMENDMENT
1. After upgrading, expanding the scale or upgrading radiation equipment, the licensee must apply for license amendment;
2. Application for license amendment shall comprise of:
a) Amendment application using form 08/ATBX-CP as in Annex 3 to this Circular;
b) A copy of the current license;
c) A report on radiation safety of the upgraded facility or equipment;
3. The valid duration of the amended license is that of a new license.
XIV. REGISTRATION AND LICENSE RE-ISSUANCE
1. A registrant or licensee whose registration or license is lost can apply for reissuance.
A registrant or licensee when becoming aware of the loss of their registration or license must immediately report to the local public security department and the Regulatory Authority, and announce on public media.
30 days after the announcement, if the lost registration or license cannot be found, the registrant or licensee can apply for re-issuance.
An application for re-issuing registration or license shall comprise of:
a) A request for re-issuing registration or license using form 09/ATBX-CP as in Annex 3 to this Circular;
b) Confirmation of the Public Security Department on the loss of the registration or license;
c) Confirmation of Press Agencies on the announcement of the loss of the registration or license.
2. A registrant or licensee whose registration or license is ruined, can apply for reissuance.
The application for re-issuing registration and license shall comprise of:
a) Application for re-issuing registration or license;
b) The original ruined registration and license.
XV. DURATION FOR PROCESSING OF DECLARATION AND REGISTRATION, LICENSE APPLICATION
1. For declaration:
Within 10 working days after the date of receiving the declaration (as of registered mail), the Regulatory Authority must issue declaration confirmation.
2. For the application of registration, license, amendment and renewal (herein called application for registration and license):
Within 5 working days after the date of receiving the application, the Regulatory
Authority shall request the applicant to supplement lacking documents if any.
Within 30 days after the date of transmission of the notification (as of registered mail), if the Regulatory Authority has not received the supplementary documents, the application shall be rejected without returning the application.
Within 60 days after the date of receiving the completed application, the
Regulatory Authority shall conduct verification. Within 10 days after the date of receiving verification results, the Regulatory Authority shall issue a registration or license, or reject the application. If the application is rejected, the Regulatory
Authority shall inform the applicant in writing of the rejection and clearly state reasons for rejection.
3. For the application of license re-issuance :
Within 30 days after the date of receiving a completed application, the Regulatory
Authority shall re-issue the registration or license.
XVI. REVOCATION OF LICENSE
1. The license shall be revoked if:
a) The Regulatory Authority becomes aware of any fault or untruthful information in the application;
b) The licensee violates radiation safety regulations during operation;
c) A situation relating to technological issues, which was not known at the time of license authorization, arises (nature), and can affect the radiation safety;
d) A licensed radiation facility is dissolved or bankrupt;
dd) The person holding the license is deprived of civil rights;
2. The Regulatory Authority shall issue revocation decision, notify the licensee and legal basis explanation for the revocation.
3. The revocation shall be applied immediately after the licensee receives the notification;
4. Effect of the revocation
A revocation can
a) immediately stop a radiation practice;
b) force the licensee to implement measures for ensuring radiation safety;
c) force the licensee hand in the original license to the Regulatory Authority.
I. HANDLING VIOLATION
Registrants/licensees violating the provisions specified in the Circular shall be subject to administrative sanctions or criminal prosecution, depending on the nature and scope of the violation and its consequences; and bear compensation if there is damage.
II. ENTRY INTO FORCE
The Circular shall entry into force after 15 days from the date of announcing on the official gazette and replaces regulations specified in Part III of Regulations for declaration and issuance of registration and license in the Joint Circular No. 2237/1999/TTLT/BKHCNMT-BYT issued on the 28th December 1999 by the Ministry of Science and Technology and the Ministry of Health Organizations, individuals who possess radiation facilities, radioactive sources, and radioactive wastes or conduct radiation practice and have been registered or licensed before the issuance of the Circular will not have to apply for declaration, registration and license issuance and continue their operation according to duration stated in effective license.
If there are any problems/difficulties in the implementation of this Circular, it is requested to inform the Ministry of Science and Technology so as to review, amend and supplement the Circular if necessary.
Le Dinh Tien