Circular No. 05/2006/TT-BKHCN guiding procedures for declaration, issuance of registration certificates, and issuance of permits for activities related to radiation

CIRCULAR

Guidelines for the declaration, issuance of registration certificates, and issuance of permits for activities related to radiation

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Pursuant to Decree No. 50/1998/NĐ-CP dated July 16, 1998 of the Government detailing the implementation of the Ordinance on Radiation Safety and Control;

Pursuant to Decree No. 54/2003/NĐ-CP dated May 19, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Science and Technology, and Decree No. 28/2004/NĐ-CP dated January 16, 2004 of the Government amending and supplementing certain articles of Decree No. 54/2003/NĐ-CP dated May 19, 2003,

The Ministry of Science and Technology issues guidelines for the declaration, issuance of registration certificates, and issuance of permits for activities related to radiation as follows:

PART I. GENERAL PROVISIONS

I. Scope of Application

1. This Circular guides the declaration, issuance of registration certificates, and issuance of permits for activities related to radiation, including:

a) Declaration regarding radiation facilities, radiation sources, radioactive waste;

b) Issuance of registration certificates for radiation sources, storage sites for radioactive waste;

c) Issuance of permits for the operation of radiation facilities, permits for performing radiation work, permits for special radiation workers;

d) Issuance of permits for upgrading, expanding the scope, and purpose of radiation facility operations, upgrading radiation equipment;

e) Issuance of permits for radiation safety services.

2. This Circular does not apply to:

a) Orphaned radioactive sources and radioactive waste;

b) Nuclear reactor operations;

c) Activities within the nuclear fuel cycle (excluding uranium and thorium ore extraction, processing, and research and development activities related to the nuclear fuel cycle);

d) Activities related to radiation exempted from declaration, registration, and permit issuance according to Vietnam Standard TCVN 6870:2001 "Radiation Safety - Exemptions from Declaration, Registration, and Permitting" and other relevant laws.

3A permit for the operation of a radiation facility issued in accordance with this Circular is a specialized permit in the field of radiation safety and does not replace other permits required by law.

II. Declaration

Organizations and individuals with radiation facilities, radiation sources, radioactive waste must declare to the competent authority.

III. Registration Certificate

Organizations and individuals with radiation sources, storage sites for radioactive waste must apply for registration certificates for radiation sources and storage sites for radioactive waste from the competent authority.

IV. Permit for Operation of Radiation Facilities

Organizations and individuals with radiation facilities must apply for permits for the operation of radiation facilities.

Radiation facilities may only conduct radiation work listed in the permit.

V. Permit for Performing Radiation Work

When conducting radiation work outside those listed in the permit for the operation of radiation facilities, radiation facilities must apply for supplementary permits for performing radiation work (except in cases requiring modification of the permit under Section XIII, Part II).

For facilities without a permit for the operation of radiation facilities when conducting non-routine radiation work, they must apply for permits for performing radiation work.

One permit for performing radiation work can be issued for one or more radiation works.

VI. Permit for Special Radiation Workers

Special radiation workers must apply for permits if they perform the following tasks:

1. Installation, operation, maintenance, repair, and emergency response for radiation sources, nuclear reactors, accelerators, radiotherapy machines, industrial irradiation equipment, and industrial radiography equipment;

2. Production of radioactive isotopes;

3. Decontamination and emergency response for radiation incidents at level 2 or higher, as stipulated in Article 18 of Decree No. 50/1998/NĐ-CP dated July 16, 1998 of the Government detailing the implementation of the Ordinance on Radiation Safety and Control (hereinafter referred to as Decree No. 50/1998/NĐ-CP).

VII. Permit for Upgrading, Expanding Scope, and Purpose of Radiation Facility Operations, and Upgrading Equipment radiation

When wishing to upgrade, expand the scope, and purpose of radiation facility operations beyond the provisions of the permit for the operation of radiation facilities, or when wishing to upgrade radiation equipment beyond the content of the registration certificate, radiation facilities must submit applications for permits for upgrading, expanding the scope, and purpose of radiation facility operations, or upgrading radiation equipment.

After completing the upgrade, expansion of the scope, and purpose of radiation facility operations, or upgrading radiation equipment, radiation facilities must apply for modifications to the permit or issue new registration certificates.

VIII. Permit for Radiation Safety Services

Facilities providing personal dosimetry measurement, radiation inspection, testing, and calibration of radiation measuring equipment, and radiation equipment must apply for permits for radiation safety services.

IX. Competent Authority Confirming Declarations, Issuing Registration Certificates, and Issuing Permits

1. The Ministry of Science and Technology confirms declarations, issues registration certificates, and issues permits in the field of radiation safety for all types of activities, except for those specified in Clause 2 below.

2. Provincial Departments of Science and Technology directly under the Central Government confirm declarations, issue registration certificates, and issue permits related to medical X-ray diagnostic equipment in accordance with this Circular.

X. Fees and Charges

Organizations and individuals applying for registration certificates, issuing, renewing, modifying, or reissuing permits must pay fees and charges as prescribed by law. The fee and charge levels are determined corresponding to the radiation source codes and radiation work codes specified in Appendices I and II attached to this Circular.

Organizations and individuals proposing to apply for registration, issuance, extension, amendment, reissuance of permits shall pay fees and charges as prescribed by law. The amount of fees and charges is determined correspondingly for radiation source codes and radiation work codes specified in Appendices I and II attached hereto.

Part II. PROVISIONS ON REPORTING, REGISTRATION, AND LICENSE GRANTING

I. Reporting Procedures

1. Within seven working days from the date of having a radiation source, radiation source, or radioactive waste, organizations and individuals must report to the competent authority according to the corresponding reporting forms prescribed in Appendix 4 issued together with this Circular (forms 10/ATBX-CP, 13/ATBX-CP, 15/ATBX-CP).

2. In cases where organizations and individuals proceed with the application for registration certificate or license within the aforementioned time limit, they are exempted from performing the reporting procedures.

II. Registration Certificate Issuance Procedures

1. Within thirty days from the date of having a radiation source or radioactive waste storage location, organizations and individuals must submit the application dossier for issuance of the registration certificate to the competent authority.

2. The application dossier for issuance of the registration certificate for a radiation source includes:

a) Application form for issuance of the registration certificate, according to Form 01/ATBX-CP prescribed in Appendix 3 issued together with this Circular;

b) Radiation source reporting form, according to Form 13/ATBX-CP prescribed in Appendix 4 issued together with this Circular;

c) Copy of the radiation source history; in case the radiation source history is lost, organizations and individuals must re-determine the activity, radionuclide name (for radioactive sources) and technical parameters of the equipment (for radiation equipment);

d) Technical dossier on the radioactive source storage location (technical drawings signed by the designer and drafter), assessment of the surrounding radiation background at the radioactive source storage location; clearly specify security and safety measures for radioactive sources.

3. The application dossier for issuance of the registration certificate for a radioactive waste storage location includes:

a) Application form for issuance of the registration certificate for a radioactive waste storage location, according to Form 01/ATBX-CP prescribed in Appendix 3 issued together with this Circular;

b) Radioactive waste storage location reporting form according to Form 14/ATBXCP prescribed in Appendix 4 issued together with this Circular;

c) Description of the origin of radioactive waste, radioactive waste activity; accompanied by a technical dossier on the radioactive waste storage location (technical drawings signed by the designer and drafter), assessment of the surrounding radiation background at the radioactive waste storage location; clearly specify security and safety measures for radioactive waste.

4. In cases where organizations and individuals simultaneously proceed with the application for issuance of the registration certificate and the application for issuance of the license within the aforementioned time limit, they only need to submit the application form for issuance of the registration certificate along with the application dossier for issuance of the license.

III. Dossier for Application for Issuance of Operating License for a Radiation Facility

The dossier for application for issuance of operating license for a radiation facility includes:

1. Application form for issuance of operating license for a radiation facility, according to Form 02/ATBX-CP prescribed in Appendix 3 issued together with this Circular;

2. Radiation facility reporting form according to Form 10/ATBX-CP prescribed in Appendix 4 issued together with this Circular;

3. Radiation safety officer reporting form according to Form 11/ATBX-CP prescribed in Appendix 4 issued together with this Circular;

4. Radiation worker reporting form according to Form 12/ATBX-CP prescribed in Appendix 4 issued together with this Circular;

5. Radiation source reporting form according to Form 13/ATBX-CP prescribed in Appendix 4 issued together with this Circular;

6. Radioactive waste storage location reporting form according to Form 14/ATBX-CP prescribed in Appendix 4 issued together with this Circular;

7. Radioactive waste reporting form according to Form 15/ATBX-CP prescribed in Appendix 4 issued together with this Circular;

8. Radiation safety evaluation report containing contents prescribed in Section VII, Part II of this Circular;

9. Copies of accompanying documents and materials, including:

a) Decision on establishment of the radiation facility or business license;

b) Acceptance dossier for construction of rooms housing radioactive sources and radiation equipment, shielding calculations for these rooms;

c) Acceptance dossier for construction of radioactive waste storage facilities and radioactive waste storage locations;

d) Registration certificate for radiation sources (if applicable);

đ) Registration certificate for radioactive waste storage locations (if applicable);

e) Radiation source history; in case the radiation source history is lost, organizations and individuals must re-determine the activity, radionuclide name (for radioactive sources) and technical parameters of the equipment (for radiation equipment);

g) User guide, inspection, and maintenance documentation for radiation sources provided by the manufacturer or supplier (if applicable); manufacturer's certification for radioactive sources and radiation equipment;

h) Appointment decision for radiation safety officer; radiation safety training certificate of the radiation safety officer issued by a training institution authorized by the Ministry of Science and Technology;

i) Radiation safety training certificate (if applicable), professional and vocational certificates of radiation workers;

k) Service contract for individual radiation dose determination with a facility designated by the State management agency for radiation safety and control under the Ministry of Science and Technology;

l) Special radiation work permit for employees (for radiation facilities conducting special radiation work).

If the facility does not have a radiation source, then it is not required to comply with the provisions set out in Clause 5, Points b, d, e, g of Clause 9 of this Section.

If the facility does not have radioactive waste, then it is not required to comply with the provisions set out in Clauses 6, 7, Points c, đ of Clause 9 of this Section.

IV. Dossier for Application for Issuance of License to Conduct Radiation Work

The dossier for application for issuance of license to conduct radiation work includes:

1. Application form for issuance of license to conduct radiation work, according to Form 03/ATBX-CP prescribed in Appendix 3 issued together with this Circular;

2. Radiation source reporting form according to Form 13/ATBX-CP prescribed in Appendix 4 issued together with this Circular. In cases where radiation work is not related to a radiation source, this content is not required;

3. Radioactive waste storage location reporting form according to Form 14/ATBX-CP prescribed in Appendix 4 issued together with this Circular. In cases where there is no radioactive waste, this content is not required;

4. Radiation safety evaluation report containing contents prescribed in Section VII, Part II of this Circular (additional evaluation for radiation work).

5. Documents and materials attached as provided in Clause 9 Section III Part II of this Circular (excluding documents and materials submitted when requesting permission to operate the radiation facility).

V. Documents for Requesting Permission to Upgrade, Expand Scope, or Change Purpose of Operation of Radiation Facilities or Upgrade Radiation Equipment

1. Application for permission to upgrade, expand scope, or change purpose of operation of the radiation facility outside the provisions of the permit (or upgrade radiation equipment) according to Model 04/ATBX-CP stipulated in Appendix 3 issued together with this Circular;

2. Proposal for upgrading the scope, expanding the purpose of operation (or upgrading radiation equipment) related to radiation safety;

3. Safety justification;

4. Environmental impact assessment regarding radiation safety when putting the facility or equipment into operation.

VI. Documents for Requesting Permission for Radiation Safety Services

1. Application for permission for radiation safety services according to Model 05/ATBX-CP stipulated in Appendix 3 issued together with this Circular;

2. List of staff performing radiation safety services along with copies of certificates and training qualifications relevant to their work;

3. Inventory of measuring devices and calibration devices, along with copies of calibration certificates;

4. Safety analysis of procedures for implementing services;

5. Regulations of the service provider on quality assurance and quality control procedures;

6. Sample result report form for service implementation.

A radiation safety service provider that has a radiation source must follow the procedures for obtaining a permit as prescribed for radiation facilities.

VII. Contents of the Radiation Safety Assessment Report

1. The radiation safety assessment report includes the following contents:

a) The rationality and necessity of conducting radiation work;

b) Technical parameters, history of the radiation source or manufacturer's certificate of the radiation source;

c) Usage, inspection, maintenance procedures for the radiation source;

d) Calibration data (for radiation equipment);

đ) Shielding design;

e) Disposal or removal method when the radioactive source expires;

g) Safety and security measures for radiation sources and radioactive waste;

h) List of radiation warning devices, technical features;

i) List of radiation dose measurement devices, technical features;

k) Radiation background evaluation;

l) Measures to ensure safety for radiation workers and residents;

m) Environmental impact assessment regarding radiation safety;

n) Human resource conditions including the radiation facility manager, radiation safety supervisor, radiation workers, and special radiation work personnel (if any);

o) Work procedures and radiation safety regulations of the facility;

p) Emergency response plan;

q) Financial conditions including sufficient financial resources to implement radiation safety measures and address radiation incidents.

2. In addition to the contents specified in Point 1 of this Section, for specific activities below, the radiation safety assessment report must include additional contents as follows:

a) Using radiation sources in healthcare: radiation safety analysis for patients and treatment/diagnostic subjects; results of quality testing of radiation equipment conducted by a facility permitted by the Ministry of Science and Technology;

b) Research and training in radiation and nuclear science using radiation sources: radiation safety analysis for researchers, instructors, and students;

c) Producing consumer products containing radioactive substances: safety analysis for consumers; technical documentation on storage facilities for consumer products containing radioactive substances and surrounding radiation background assessment;

d) Mining and processing radioactive ores and mineral sands with radioactive content: description of mining and processing procedures; safety analysis of mining and processing technology; ore quantity, post-mining and processing waste quantity; radionuclides and their concentrations in the ore and waste;

đ) Production of radioactive sources and production and assembly of radiation equipment: description and production process of radiation sources, quality tests of radiation sources (accompanied by technical drawings signed by the designer and drafter), waste management solutions (if applicable); design approval certificate from the competent authority of the producing country;

e) Radioactive waste management: description of radioactive waste management procedures; amount of radioactive waste managed and stored; radionuclides and their concentrations in the radioactive waste; safety analysis of radioactive waste management technology;

g) Radiation equipment repair and replacement services: specifications and characteristics of equipment used for repair and replacement of radiation sources, radiation measurement devices with copies of calibration certificates, calibration devices; safety analysis of repair and replacement procedures; regulations of the service provider on quality assurance and quality control procedures;

h) Transfer of radiation sources: analysis of the capability of the transferring and receiving facilities, transportation and storage conditions; transfer agreement;

i) Export and import of radiation sources: analysis of the capability of the receiving or owning facility, export and import conditions, transportation and storage conditions; manufacturer's certificate and approval certificate from the competent authority of the producing country for open or sealed radioactive sources with half-life less than six months (no certificate required for import application but must be sent to the competent authority after importation); export and import agency commission agreements (if any), accompanied by copies of the business license of the export and import service provider;

k) Transit of radiation sources: safety analysis of transit conditions, transportation, and storage; contracts;

l) Radiation work involving transport of radioactive sources or radioactive waste: description of transportation procedures, safety analysis of transportation conditions for radioactive sources according to Circular No. 14/2003/TT-BKHCN dated July 11, 2003 guiding safe transportation of radioactive materials.

3. Templates for Radiation Safety Assessment Reports for certain types of radiation facilities and specific radiation work are guided by the Radiation Control and Safety Agency.

3. Sample Safety Assessment Report for certain types of radiation facilities and specific radiation works shall be guided by the Radiation and Nuclear Safety Control Agency.

VIII. APPLICATION DOCUMENTS FOR THE ISSUE OF LICENSES FOR EMPLOYEES ENGAGED IN SPECIAL RADIATION WORK

The application documents for the issue of licenses for employees engaged in special radiation work include:

1. A license application form for employees engaged in special radiation work according to Model 06/ATBX-CP as prescribed in Appendix 3 attached hereto;

2. A radiation worker declaration form according to Model 12/ATBX-CP as prescribed in Appendix 4 issued herewith;

3. Copies of certificates and diplomas issued by training institutions authorized by the Ministry of Science and Technology for radiation safety training;

4. Copies of other certificates and diplomas;

5. Health certificate from a medical facility at district level or higher.

IX. GENERAL REQUIREMENTS FOR APPLICATION DOCUMENTS AND LICENSE ISSUANCE

1. Organizations and individuals applying for registration certificates and licenses shall prepare two sets of application documents in accordance with the prescribed forms and submit them to the competent authority for confirmation of declaration and issuance of registration certificates and licenses, as stipulated herein.

2. Information in the application documents must be truthful. Documents in foreign languages (except English) must be translated into Vietnamese. Copies and translations must be certified by the organization or individual making the application.

3. Application documents must be placed in envelopes and submitted directly to the office of the competent authority or sent via postal service; facsimile submissions will not be accepted.

X. CONDITIONS FOR THE ISSUE OF REGISTRATION CERTIFICATES AND LICENSES

Organizations and individuals may only be issued registration certificates and licenses if they meet all of the following conditions:

1. Submitting complete application documents as prescribed herein;

2. Ensuring compliance with radiation safety regulations as stipulated by law;

3. Paying the radiation safety assessment fee and registration and licensing fees as prescribed by law.

XI. VALIDITY PERIOD OF REGISTRATION CERTIFICATES AND LICENSES

1. The validity period of a registration certificate is effective until the radiation source or radioactive waste storage location is recognized by the competent State management agency for radiation safety as meeting the necessary conditions and standards for exemption from registration, or until the radiation source or radioactive waste storage location is transferred to another organization or individual.

The transferee organization or individual is responsible for submitting new registration certificate applications.

2. The validity period of a license is specified in Decree No. 50/1998/NĐ-CP dated July 16, 1998 of the Government detailing the implementation of the Radiation Safety and Control Ordinance and is recorded on the license, specifically as follows:

a) Licenses for radiation facilities using accelerators and irradiation equipment for all purposes, including radiotherapy facilities, have a validity period of five years;

b) Licenses for other radiation facilities have a validity period of three years;

c) Licenses for employees engaged in special radiation work have a validity period of three years;

d) Licenses for conducting radiation work have validity periods appropriate to the nature of each type of work, but not exceeding three years.

XII. EXTENSION OF LICENSES

1. Sixty days before the expiration of a license, the licensee must apply for its extension. If the licensee applies for an extension after this time, the extension application will not be considered, and the facility must apply for a new license.

2. The application documents for license extension include:

a) An application form for license extension according to Model 07/ATBX-CP as prescribed in Appendix 3 issued herewith;

b) A declaration form regarding changes compared to the previous license application;

c) A report on radiation safety during the previous license period;

d) A copy of the expiring license.

XIII. AMENDMENT OF LICENSES

1. Organizations and individuals holding licenses must request the issuing authority to amend the license after completing upgrades, expansions, or changes in the scope and purpose of radiation facilities or upgrading radiation equipment;

2. The application documents for license amendment include:

a) An application form for license amendment according to Model 08/ATBX-CP as prescribed in Appendix 3 issued herewith;

b) A copy of the license to be amended;

c) A radiation safety evaluation report after completing upgrades or expansions of the radiation facility or radiation equipment;

3. The validity period of the amended license is calculated from the date of issuance of the new license.

XIV. REISSUE OF REGISTRATION CERTIFICATES AND LICENSES

1. In case of loss of registration certificates or licenses, organizations and individuals holding such certificates and licenses may apply for reissue. Upon losing the registration certificate or license, the holder must immediately report to the police station where the loss occurred, the issuing authority, and announce the loss through mass media.

After thirty days from the announcement date, if the organization or individual has not found the lost registration certificate or license, they should request the competent authority to reissue it.

The application documents for reissuing registration certificates and licenses include:

a) An application form for reissuance of registration certificates and licenses according to Model 09/ATBX-CP as prescribed in Appendix 3 issued herewith;

b) Confirmation from the police station regarding the declaration of loss of the registration certificate or license;

c) Confirmation from the press or broadcasting station regarding receipt of the announcement of loss of the registration certificate or license.

2. In case of damage or deterioration of registration certificates or licenses, organizations and individuals holding such certificates and licenses may apply for reissue. The application documents include:

a) An application form for reissuance of registration certificates and licenses;

b) The original damaged or deteriorated registration certificate or license.

XV. TIME LIMIT FOR PROCESSING APPLICATION DOCUMENTS AND ISSUANCE OF DECLARATION CONFIRMATION, REGISTRATION CERTIFICATES, AND LICENSES

1. For declaration application documents:

Within ten working days from the date of receipt of the declaration application documents (as evidenced by the postmark of the receiving post office), the competent authority must issue a declaration confirmation.

2. For application documents for registration certificates and licenses, amendment, and extension (collectively referred to as application for registration certificates and licenses in this point):

Within five working days from the date of receiving the file, the competent authority must notify the organization or individual requesting issuance of registration certificates or supplementary permits to complete the missing documents. If within thirty days from the date of receipt of the notification (as evidenced by postmark), the competent authority does not receive the supplementary documents, the issuance of the registration certificate or permit will be refused without returning the file.

Within sixty days from the date of receiving all necessary files, the competent authority must organize an assessment. Within ten days from the date of the assessment result, the competent authority must issue or refuse to issue the registration certificate or permit. In case of refusal to issue the registration certificate or permit, the competent authority must notify in writing the organization or individual who submitted the application for the registration certificate or permit, stating the reasons for refusal.

For applications for import permits, temporary import for re-export, or temporary export for re-import, within fifteen days from the date of receiving all necessary files, the competent authority must organize an assessment; within five working days from the date of the assessment result, the competent authority must issue or refuse to issue the permit.

3. For applications for reissuance of permits:

Within thirty days from the date of receiving all necessary files, the competent authority must reissue the registration certificate or permit.

XVI. Revocation of Permits

1. A permit shall be revoked when:

a) The competent authority discovers that the information declared in the application for the permit is not truthful or fraudulent;

b) According to the decision or recommendation of the competent authority, due to the actions of the organization or individual holding the permit that violate radiation safety laws during their operations;

c) New conditions arise from a technical perspective or other essential aspects not known at the time of issuing the permit, which may affect the conditions ensuring radiation safety;

d) The radiation facility holding the permit is dissolved or bankrupted;

đ) The individual holding the permit loses their citizenship rights.

2. The issuing authority shall issue a decision to revoke the permit. The decision must clearly explain the legal basis and reasons for revoking the permit and must notify the permit holder.

3. The revocation of the permit takes effect immediately upon the permit holder receiving the notification.

4. The effect of the revocation of the permit:

a) Immediately cease all radiation activities;

b) Compel the permit holder to implement measures to ensure radiation safety;

c) Compel the permit holder to return the original permit to the competent authority.

Part III. IMPLEMENTATION

I. Handling Violations

Organizations or individuals violating the provisions of this Circular, depending on the nature, degree, and consequences of the violation, shall be subject to administrative penalties, compensation for damages (if applicable). In cases where criminal elements are present, they shall be held criminally responsible according to the law.

II. Effective Date

This Circular shall take effect fifteen days from the date of publication in the Official Gazette and replaces the provisions of Section III "Regulations on Declaration, Issuance of Registration Certificates, and Issuance of Permits" in Joint Circular No. 2237/1999/TTLT/BKHCNMT-BYT dated December 28, 1999, issued by the Ministry of Science, Technology, and Environment and the Ministry of Health guiding the implementation of radiation safety in healthcare.

Organizations or individuals with radiation facilities, sources, radioactive waste, or conducting radiation work that have been registered or permitted before the effective date of this Circular shall not need to resubmit declarations or registrations and may continue their operations according to the validity period specified in the currently valid permit.

During implementation, if there are any difficulties, they should promptly report to the Ministry of Science and Technology for research, revision, and supplementation./.