Nghị định 142/2020/ND-CP

DECREE

ON IMPLEMENTATION OF RADIATION-RELATED AFFAIRS AND PROVISION OF AUXILIARY SERVICES FOR ATOMIC ENERGY APPLICATION

Pursuant to Law on Governmental Organization dated June 19, 2015; Law on amendments to Law on Government Organization and Law on Local Governmental Organization dated November 22, 2019;

Pursuant to Law on Atomic Energy dated June 3, 2008;

Pursuant to Law on Investment dated November 26, 2014 and Law on Amendments to Article 6 and Annex 4 regarding List of conditional business lines of Law on Investment dated November 22, 2016;

At request of Minister of Science and Technology;

The Government promulgates Decree on implementation of radiation-related affairs and provision of auxiliary services for atomic energy application.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

1. This Decree prescribes eligibility, application and procedures for issuance of radiation-related affair permit, registration for provision of auxiliary services for atomic energy application and certificate for provision of auxiliary services for atomic energy application.

2. Radiation-related affairs specified under this Decree include:

a) Using radiation sources;

b) Manufacturing and preparing radioactive substances;

c) Temporarily storing radiation sources and processing, storing used radioactive waste and radiation sources;

d) Employing radiation devices and operating irradiators.

dd) Developing radiation facilities;

e) Terminating operation of radiation facilities;

g) Exporting radiation sources, source materials, nuclear materials and nuclear equipment;

h) Importing radiation sources, source materials, nuclear materials and nuclear equipment;

i) Packaging, transporting and transiting radiation sources, source materials and nuclear materials.

3. Auxiliary services for atomic energy application specified under this Decree include:

a) Providing technical and technological advice in atomic energy, including: Technical and technological advice regarding radiation and atomic technology for organizations and individuals to conduct activities in the field of atomic energy other than research and technology development’

b) Assessing radiation technology and nuclear technology; appraising radiation technology and nuclear technology;

c) Radiation monitoring;

d) Radioactive decontaminating;

dd) Assessing radioactivity;

e) Installing, maintaining and repairing radiation devices;

g) Measuring personal exposure;

h) Inspecting radiation devices;

i) Calibrating radiation gauges;

k) Experimenting radiation devices;

l) Providing radiation safety training; providing specialize professional training for individuals providing services specified from Point a to Point k this Clause (hereinafter collectively referred to as “professional training”).

4. Import and export of radiopharmaceuticals shall be managed according to regulations and law on pharmaceuticals.

5. Survey and extraction of radioactive ore shall be managed according to regulations and law on minerals.

Article 2. Regulated entities

Regulatory authorities, organizations and individuals related to implementation of radiation-related affairs and provision of auxiliary services for atomic energy application specified under Clause 2 Article 1 of this Decree.

Article 3. Term interpretation

In this Decree, terms below are construed as follows:

1. “using radiation sources” refers to use of open or close radiation sources; excluding radiation sources attached to radiation devices.

2. “using radiation devices” refers to the use of devices attached with radiation sources or generators of X-ray, neutron, electron and other charged particles, excluding operation of irradiators.

3. “operating irradiators” refers to the use of accelerators, radiotherapy equipment or irradiators for sterilization, mutation and material processing.

4. “using diagnostic X-ray devices in medical” refers to the use of X-ray generators in medical diagnosis, including general radiographic equipment, fluoroscopy equipment, dental radiographic equipment, mammographic equipment, mobile radiographic equipment, computer tomography (other than computer topography integrated with PET, SPECT (PET/CT, SPECT/CT)), bone densitometry, veterinary X-ray equipment.   

5. “temporarily storing radiation sources” refers to storage of radiation sources from the date of receipt until the date on which the radiation sources are brought into use or transferred to other organizations and individuals, excluding licensed storage of used radiation sources and storage of radiation sources that are being used. 

6. “installing, maintaining and repairing radiation devices” refers to installation of accelerators, removal and installation of radiation sources, component maintenance and repair which affects radiation safety features of accelerators and devices attached with radiation sources. 

7. “testing radiation devices” refers to identification of technical characteristics related to radiation safety of radiation devices or radiating components.

8. “adequate application” refers to application which contains adequate documents with contents declared according to this Decree.

Article 4. General requirements

1. Organizations and individuals conducting radiation-related affairs specified under Clause 2 Article 1 of this Decree must obtain license for radiation-related affairs, except affairs related to:

a) Radiation devices and radiation sources receiving exemption from declaration and licensing according to National Technical Regulation QCVN 5:2010/BKHCN on Radiation safety - Exemption from declaration and licensing;

b) Use of consumption goods exposed to radiation or containing radioactive substances.

2. Facilities specified under Clause 1 Article 34 of Law on Atomic Energy must obtain license for construction of radiation facilities before constructing, renovating or expanding equipment rooms, except for:

a) Operating facilities of irradiators with self-shielding mechanisms according to manufacturer’s design;

b) Operating facilities of mobile accelerators for goods screening.

3. Prior to termination of operation, following radiation facilities must obtain license for termination of operation of:

a) Industrial irradiating facilities utilizing radiation sources;

b) Facilities for manufacturing and preparing radioactive substances;

c) Other radiation facilities producing radioactive wastes during implementation of radiation-related affairs.

4. Organizations and individuals shall be issued with radiation-related affairs permit only when they have satisfied eligibility specified under Point a Clause 1 and Point a Clause 2 Article 75 of Law on Atomic Energy and Chapter II of this Decree.

5. If applications for use permit, operation permit are not submitted or transfer is not conducted within 30 days from the day of receiving radiation sources or equipment attached with radiation sources, receivers must submit application for issuance of temporary storage of radiation sources. 

6. Organizations and individuals must obtain permit for processing and storing used radiation sources in order to process or store used radioactive wastes and radiation sources. This requirement does not apply to national radioactive waste storage, facilities for processing and storing used radioactive wastes and radiation sources.

7. Organizations and individuals providing auxiliary services for atomic energy application specified under Clause 3 Article 1 of this Decree must obtain registration for operation (for organizations) or practice permit (for individuals). 

8. Organizations shall only be issued with registration for provision of auxiliary services for atomic energy application once they have satisfied requirements specified under Points a and b Clause 1 Article 69 of Law on Atomic Energy and Chapter III of this Decree.

9. Providers of auxiliary services for atomic energy applications specified under Point b Clause 3 Article 1 of this Decree must be science and technology enterprises or organizations formed and registering for operation as per the law.

10. Individuals shall only be issued with practice permit for provision of auxiliary services for atomic energy application once they have satisfied requirements specified under Clause 1 Article 70 of Law on Atomic Energy and Chapter III of this Decree.

Chapter II

ELIGIBILITY AND PROCEDURES FOR ISSUANCE OF RADIATION-RELATED AFFAIR PERMIT

Section 1. ELIGIBILITY FOR ISSUANCE OF RADIATION-RELATED AFFAIR PERMIT

Article 5. Using radiation sources

1. Human resources

a) Radiation employees must obtain certificate for safety radiation training satisfactory to radiation-related affairs;

b) Safety personnel must be employed. Safety personnel must obtain certificate for radiation employees and be assigned according to documents which specify responsibilities and powers according to Clause 2 Article 27 of Law on Atomic Energy;

c) In case open radiation sources are employed: Employ individuals responsible for radioactive decontamination. Individuals responsible for radioactive decontamination must obtain certificate for radiation employee;

d) In case of using open radiation sources in nuclear medicine (radiopharmaceuticals), employ employees who have received medical physic training.

2. Safety and security assurance

a) Ensuring radiation exposure in regular working conditions as follows:

- For radiation employees

+ Effective dose does not exceed 20 mSv/year (average value in 5 consecutive years) and does not exceed 50 mSv in any year during this period;  

+ Similar dose for eye lens does not exceed 20 mSv/year (average value in 5 consecutive years) and does not exceed 50 mSv in any year during this period;  

+ Similar dose for skin does not exceed 500 mSv/year for specific forms of radiation-related affairs.

- For the general public

+ Effective dose does not exceed 1 mSv/year (average value in 5 consecutive years) and does not exceed 5 mSv in any year during this period;  

+ Similar dose for eye lens does not exceed 15 mSv/year;

+ Similar dose for skin does not exceed 50 mSv/year for the general public depending on specific radiation circumstances.

b) Establishing controlled areas and supervised areas as follows:

- Controlled areas: In areas where potential exposure is greater or equal to 6 mSv/year; in areas where radioactive contamination potentially occurs; in control rooms of nuclear reactors, radiotherapy equipment, accelerators and industrial irradiators. 

- Supervised areas: In areas where potential exposure is greater than 1 mSv/year and less than 6 mSv/year.

c) Installing radiation warning symbols according to National Standards TCVN 7468:2005 (ISO 361:1975) Radiation safety – Basic ionizing radiation symbols and National Standards TCVN 8663:2011 (ISO 21482:2007) Radiation safety – Ionizing radiation warnings – Additional symbols;

d) Developing radiation safety regulations suitable for radiation-related affairs, including regulations on: Compliance with working procedures and safety instructions; use of personal protective gears, radiation and personal exposure measuring instrument; responsibilities for informing unusual events that may cause loss of radiation safety and radiation source security; 

dd) Equipping personal dosimeters and assessing personal exposure for radiation employees at least every 3 months;

e) In case of using open radiation sources: Developing measures and systems for collecting, processing and storing radioactive wastes in solid form and liquid form while satisfying radiation safety requirements; employing materials which are convenient for radioactive decontamination as walls, floor and work surfaces in areas potentially subject to radiation contamination; employing dose rate meters and radiation contamination meters to regularly monitor radiation of working environment; providing adequate personal protective equipment against radiation contamination for employees working in controlled areas;

g) In case of using close radiation sources: Fully complying with radiation source security requirements according to Annex I of this Decree;

h) Developing response plans for facility-level radiation incidents according to Annex II of this Decree. In case of using Class 1 or Class 2 radiation sources according to National Technical Regulations QCVN 6:2010/BKHCN on Radiation safety - categories and classification of radiation sources (hereinafter referred to as “QCVN 6:2010/BKHCN”), accident response plans must be approved according to Article 36 of this Decree.

Article 6. Manufacturing and preparing radioactive substances

1. Human resources

a) Radiation employees must obtain certificate for safety radiation training satisfactory to radiation-related affairs;

b) Radioactive substance manufacturing and processing employees must receive professional training regarding manufacturing and processing radioactive substances and must obtain certificate for radiation employees;

c) Safety personnel must be employed. Safety personnel must obtain certificate for radiation employees and be assigned according to documents which specify responsibilities and powers according to Clause 2 Article 27 of Law on Atomic Energy.

2. Safety and security assurance:

a) Satisfying requirements specified under Points a, b, c, d, and dd Clause 2 Article 5 of this Decree;

b) Installing hot cells to synthesize and process radioactive substances;

c) Installing fixed exposure dose rate monitoring instrument inside and outside of radioactive substance manufacturing and processing rooms;

d) Developing measures for controlling and preventing radiation contamination, collecting, processing and storing radioactive wastes;

dd) Developing response plans for facility-level radiation incidents according to Annex II of this Decree. Accident response plans must be approved according to Article 36 of this Decree;

e) In case of manufacturing close radiation sources: Fully complying with radiation source security requirements according to Annex I of this Decree.

Article 7. Temporary storage of radiation sources; processing and storage of used radioactive waste and radiation sources

1. Human resources

a) Radiation employees must obtain certificates for safety radiation training suitable for radiation-related affairs; employees for processing used radioactive substances and radiation sources must receive specialized training regarding processing of used radioactive substances and radiation sources;

b) Safety personnel must be employed except for cases of class 5 radiation sources according to QCVN 6:2010/BKHCN. Safety personnel must obtain certificate for radiation employees and be assigned according to documents which specify responsibilities and powers according to Clause 2 Article 27 of Law on Atomic Energy;

c) In case of processing used radioactive wastes and radiation sources: Employ personnel in charge of radioactive decontamination. Individuals responsible for radioactive decontamination must obtain certificate for radiation employee.

2. Safety and security assurance for temporary storage of radiation sources

a) Satisfying requirements specified under Points a, b, c, and e Clause 2 Article 5 of this Decree;

b) Installing separate spaces to store radiation sources;

c) Developing radiation safety regulations related to storage of radiation sources and responsibilities for informing unusual events that may cause loss of radiation safety and radiation source security;

d) In case of storing close radiation sources: Fully complying with radiation source security requirements according to Annex I of this Decree;

3. Safety and security assurance for processing and storing used radioactive wastes and radiation sources

a) Satisfying requirements specified under Points a, b, c, d, and dd Clause 2 Article 5 of this Decree;

b) Installing storage for used radioactive wastes and radiation sources;

c) In case of processing radioactive substances, install temporary storage for radioactive wastes before processing;

d) In case of storing used radiation sources: Fully complying with radiation source security requirements according to Annex I of this Decree;

dd) Developing response plans for facility-level radiation incidents according to Annex II of this Decree. In case of processing or storing Class 1 or Class 2 used radioactive wastes or radiation sources according to National Technical Regulations QCVN 6:2010/BKHCN, accident response plans must be approved according to Article 36 of this Decree.

Article 8. Employment of radiation devices and operation of irradiators

1. Human resources

a) Radiation employees must receive specialized training regarding employment of radiation devices and operation of irradiators; obtain certificate for radiation safety training suitable for radiation-related affairs and certificate for radiation employees specified under Article 28 of Law on Atomic Energy; 

b) Safety personnel must be employed except for cases in which facilities only employ dental radiography equipment specializing in intraoral film, X-ray generators in X-ray fluorescence spectrometers and circuit inspection devices. Safety personnel must obtain certificate for radiation employees and be assigned according to documents which specify responsibilities and powers according to Clause 2 Article 27 of Law on Atomic Energy;

c) In case of operation of remote radiotherapy equipment: At least 1 employee who has received medical physics training must be employed for each of the equipment;  

d) In case of operation of brachytherapy equipment: At least 1 employee who has received medical physics training must be employed for each radiation facility. 

2. Safety and security assurance

a) Satisfying requirements specified under Points a, b, c, d, and đ Clause 2 Article 5 of this Decree;

b) In case of mobile use of class 1, class 2 and class 3 radiation devices attached with radiation sources according to QCVN 6:2010/BKHCN and X-ray generators in industrial radiography, employ exposure dose rate meter and equipment for establishing controlled areas and supervised areas in areas where radiation-related affairs are conducted. In case of use of radiation devices attached with radiation sources in industrial radiography, clamps and lead containers to interact with radiation sources;

c) In case of operation of irradiators: Portable dose rate meters and interlocks must be installed on doors leading in and out of rooms where irradiators are situated; systems that allow emergency shutdown of irradiation must be installed in rooms where irradiators are situated and control rooms; 

d) In case of operation of industrial irradiators, additional exposure dose rate meters must be installed inside and outside of irradiator rooms;

dd) In case of operation of irradiators or employment of irradiators in medical sector: Radiation safety regulations must be developed which specify radiation safety protection requirements for radiation employees, other medical staff, patients, patient caretakers and the general public; Valid inspection certificates for radiation devices;

e) In case of use of radiation devices and operation of irradiators attached with radiation sources: Fully complying with radiation source security requirements according to Annex I of this Decree;

g) Developing response plans for facility-level radiation incidents according to Annex II of this Decree. In case of use of class 1 and class 2 radiation equipment attached with radiation sources according to QCVN 6:2010/BKHCN, operation of irradiators, industrial radiographic equipment and accident response plans must be approved according to Article 36 of this Decree.

Article 9. Construction of radiation facilities

Having design and calculations for radiation protection (external and internal exposure) to ensure that potential exposure to radiation employees and the general public does not exceed limit exposure value according to Point a Clause 2 Article 5 of this Decree.

Article 10. Termination of operation of radiation facilities

1. Human resources

a) Radiation employees must obtain certificate for radiation safety training;

b) Safety personnel must be employed. Safety personnel must obtain certificate for radiation employees and be assigned according to documents which specify responsibilities and powers according to Clause 2 Article 27 of Law on Atomic Energy;

c) Individuals in charge of radioactive decontamination and individuals in charge of responding to radiation-related accidents. Individuals in charge of radioactive decontamination and individuals in charge of responding to radiation-related accidents must obtain certificate for radiation employees.

2. Having plans for dismantling, decontaminating radiation, processing and managing radiation sources and radioactive wastes which specified procedures, progress, human resources, equipment and financial assurance for plan execution.

Article 11. Export of radiation sources, source materials, nuclear materials and nuclear equipment

1. Have documents proving origin of radiation sources, source materials, nuclear materials and nuclear equipment.

2. Shipment of radiation sources, source materials and nuclear materials must be packed and labeled according to regulations and law on safe transportation of radiation sources, source materials and nuclear materials.

3. In case of export of class 1 and class 2 radiation sources according to QCVN 06:2010/BKHCN or nuclear materials, written import permit of authorities of importing countries is required.

Article 12. Import of radiation sources, source materials, nuclear materials and nuclear equipment

1. Safety and security assurance

a) Satisfying requirements specified under Point a Clause 2 Article 5 of this Decree;

b) Have separate storage for radiation sources until the radiation sources are brought into use or transferred to other organizations and individuals;

c) Guarantee radiation source security according to Annex 1 of this Decree.

2. In case of import of close radiation sources, guarantee to return sources to manufacturers in case of unused sources or to assure financial obligations for processing and storing used radiation sources.

Article 13. Packaging, transportation and transit of radiation sources, radioactive wastes, source materials and nuclear materials

1. Human resources

a) In case of transportation on roads and railways (except for cases of transporting exempt packages): Transport vehicle operators or escorting individuals must obtain certificates for radiation safety training;

b) In case of transporting class 1, class 2 and class 3 radiation sources according to QCVN 06:2010/BKHCN: Individuals in charge of responding to accidents must obtain certificates for radiation employees. 

2. Safety and security assurance

a) Shipment must be packed and labeled according to regulations and law on safe transportation of radiation sources, radioactive wastes, source materials and nuclear materials;

b) Equip exposure dose rate meter to monitor safety throughout transportation process;

c) Fully satisfy requirements for security assurance under Annex I of this Decree;

d) Develop response plans for facility-level radiation incidents according to Annex II of this Decree.

In case of transporting class 1 and class 2 radiation sources according to QCVN 6:2010/BKHCN and high-level radioactive wastes according to National Standards on Radiation safety – Management of radioactive wastes – Classification of radioactive wastes (TCVN 6868:2001): Response plans must be approved according to Article 36 of this Decree;

dd) Road vehicles and railway carriages must be labeled hazardous radiation commodities as per the law when transporting radiation sources, radioactive wastes, source materials and nuclear materials; 

e) In case of road transportation: May only employ automobiles and must not carry passengers (except for cases of transporting exempt packages).

3. In addition to aforementioned requirements, organizations and individuals which transport radiation sources, radioactive wastes, source materials and nuclear materials must also comply with Decree No. 42/2020/ND-CP dated April 8, 2020 of the Government on list of dangerous commodities and transportation thereof by road motor vehicles and on inland waterway.

Section 2. PROCEDURES FOR ISSUANCE OF RADIATION-RELATED AFFAIR PERMIT

Article 14. General provisions for applications for issuance of radiation-related affair permit

1. Information in applications must be accurate. Certificates, degrees or other documents must remain valid for at least 45 days from the date on which applications are received.

2. In case copies are not certified, verified or copies are produced from master registers, competent agencies capable of issuing permit may request applicants to present master registers for comparison.

3. In case applicants conduct multiple radiation-related affairs simultaneously, only 1 copy of similar documents is required for all radiation-related affairs.

Article 15. Applications for issuance of radiation-related affair permit – use of radiation sources

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.

4. Copies of certificates for radiation employees of safety personnel. In case safety personnel have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

5. Copies of certificates for radiation safety training of radiation employees.

6. Copies of certificates or degrees on medical physics training for medical physics employees of nuclear medicine facilities.

7. Declarations of close and open radiation sources using corresponding form under Annex III of this Decree.

8. Copies of manufacturers’ documents providing information on close and open radiation sources as stated in the declarations.  In case manufactures’ documents on such information are not available, applicants must submit verification results of isotopes and activity of radiation sources.

9. Assessment certificates for PET/CT, SPECT/CT equipment in case of open radiation sources attached to equipment.

10. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 5 of this Decree. Safety assessment reports shall conform to Form No. 1 under Annex V of this Decree.

11. Copies of radiation monitoring records.

12. Response plans shall conform to Annex II of this Decree.

Article 16. Applications for issuance of radiation-related affair permit – manufacturing and processing of radioactive substances

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.

4. Copies of certificates for radiation employees of employees specified under Point b and Point c Clause 1 Article 6 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

5. Copies of certificates for radiation safety training of radiation employees.

6. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 6 of this Decree. Safety assessment reports shall conform to Form No. 2 under Annex V of this Decree.

7. Copies of radiation monitoring records.

8. Response plans shall conform to Annex II of this Decree.

Article 17. Applications for issuance of radiation-related affair permit – temporary storage of radiation sources

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.

4. Copies of certificates for radiation employees of employees specified under Point b and Point c Clause 1 Article 7 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

5. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 7 of this Decree. Safety assessment reports shall conform to Form No. 3 under Annex V of this Decree.

6. Copies of radiation monitoring records.

7. Response plans shall conform to Annex II of this Decree.

Article 18. Applications for issuance of radiation-related affair permit – processing and storage of used radioactive wastes and radiation sources

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.

4. Copies of certificates for radiation employees of employees specified under Point b and Point c Clause 1 Article 7 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

5. Copies of certificates for radiation safety training of radiation employees.  Copies of certificates or degrees on training regarding radioactive waste processing for employees who process radioactive wastes.

6. Declarations of used close radiation sources using Form No. 5 under Annex III of this Decree; Declarations of radioactive wastes using Form No. 14 under Annex III of this Decree.

7. Safety assessment reports must satisfy all requirements specified under Clause 3 Article 7 of this Decree. Safety assessment reports shall conform to Form No. 7 under Annex V of this Decree.

8. Copies of radiation monitoring records.

9. Response plans shall conform to Annex II of this Decree.

Article 19. Applications for radiation-related affair permit - use of radiation devices (other than diagnostic X-ray devices in medical)

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.

4. Copies of certificates for radiation employees of employees specified under Point a and Point b Clause 1 Article 8 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

5. Copies of certificates for radiation safety training of radiation employees.

6. Declarations of radiation devices using corresponding form under Annex III of this Decree. In case of radiation devices attached by radiation sources, declare using Form No. 4 under Annex III of this Decree.

7. Copies of manufacturers’ documents providing information on radiation devices as stated in the declarations.  In case manufactures’ documents on such information are not available, applicants must submit verification results of devices’ technical specifications.

8. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 8 of this Decree. Safety assessment reports shall conform to Form No. 4 under Annex V of this Decree.

9. Copies of radiation monitoring records.

10. Response plans shall conform to Annex II of this Decree.

Article 20. Applications for radiation-related affair permit - use of diagnostic X-ray devices in medical

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.

4. Copies of certificates of radiation employees of safety personnel. In case safety personnel have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

5. Copies of certificates for radiation safety training of radiation employees.

6. Declarations of diagnostic X-ray devices in medical using Form No. 7 under Annex III of this Decree.

7. Copies of manufacturers’ documents providing information on diagnostic X-ray in medical as stated in the declarations.  In case manufactures’ documents on such information are not available, applicants must submit verification results of devices’ technical specifications.

8. Copies of assessment certificates of diagnostic X-ray devices in medical.

9. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 8 of this Decree. Safety assessment reports shall conform to Form No. 5 under Annex V of this Decree.

10. Copies of radiation monitoring records.

11. Response plans shall conform to Annex II of this Decree.

Article 21. Applications for issuance of radiation-related affair permit – operation of irradiators

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.

4. Copies of certificates for radiation employees of employees specified under Point a and Point b Clause 1 Article 8 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

5. Copies of certificates for radiation safety training of radiation employees.  Copies of certificates or degrees on medical physics training for medical physics employees of radiotherapy facilities.

6. Declarations of irradiators using corresponding form under Annex III of this Decree.

7. Copies of manufacturers’ documents providing information on irradiators as stated in the declarations.  In case manufactures’ documents on such information are not available, applicants must submit verification results of irradiators’ technical specifications.

8. Copies of assessment certificates for irradiators used in medical.

9. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 8 of this Decree. Safety assessment reports shall conform to Form No. 6 under Annex V of this Decree.

10. Copies of radiation monitoring records.

11. Response plans shall conform to Annex II of this Decree.

Article 22. Applications for issuance of radiation-related affair permit – construction of radiation facilities

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Safety analysis assessment reports on constructions of radiation facilities must satisfy all requirements specified under Article 9 of this Decree. Reports shall conform to Form No. 8 under Annex V of this Decree.

Article 23. Applications for issuance of radiation-related affair permit – termination of operation of radiation facilities

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 1 under Annex IV of this Decree.

2. Declaration of radiation employees and safety personnel using Form No. 1 under Annex III of this Decree.

3. Copies of certificates for radiation employees of employees specified under Point b and Point c Clause 1 Article 10 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

4. Safety analysis assessment reports on termination of operation of radiation facilities must satisfy all requirements specified under Clause 2 Article 10 of this Decree. Reports shall conform to Form No. 9 under Annex V of this Decree.

Article 24. Application for issuance of radiation-related affair permit - export of radiation sources, source materials, nuclear materials and nuclear equipment

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 2 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declarations of close and open radiation sources, source materials, nuclear materials and nuclear equipment using corresponding form under Annex III of this Decree.

4. Copies of documents proving origin of radiation sources, source materials, nuclear materials and nuclear equipment.

5. Copies of trade agreements or written agreements on transfer and receipt of radiation sources between Vietnamese exporting organizations, individuals and foreign importing organizations and individuals.

6. In case of export of class 1 and class 2 radiation sources according to QCVN 06:2010/BKHCN or nuclear materials or source materials: Copies of written import permit of authorities of importing countries are required.

Article 25. Application for issuance of radiation-related affair permit - import of radiation sources, source materials, nuclear materials and nuclear equipment

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 2 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required.

3. Declarations of close and open radiation sources, source materials, nuclear materials and nuclear equipment using corresponding form under Annex III of this Decree.

4. Safety assessment reports must satisfy all requirements specified under Article 12 of this Decree. Safety assessment reports shall conform to Form No. 10 under Annex V of this Decree.

5. Copies of manufacturers’ documents providing information on close and open radiation sources, source materials, nuclear materials and nuclear equipment as stated in the declarations.

6. Copies of trade agreements or written agreements on transfer and receipt of radiation sources between Vietnamese importing organizations, individuals and foreign exporting organizations and individuals.

7. Copies of entrusted import contracts between entrusting organizations, individuals and entrusted organizations, individuals in case of entrusted import.

8. In case of import of close radiation sources, guarantee to return sources to manufacturers in case of unused sources or to assure financial obligations for processing used radiation sources.

Article 26. Application for issuance of radiation-related affair permit – packaging and transportation of radiation sources, radioactive materials, source materials and nuclear materials

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 3 under Annex IV of this Decree.

2. Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies is required.

3. Declarations of escorting employees using Form No. 02 under Annex III of this Decree.

4. Declarations of close and open radiation sources, radioactive wastes, source materials and nuclear materials using corresponding form under Annex III of this Decree.

5. Copies of certificates for radiation employees of employees specified under Point b Clause 1 Article 13 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

6. Copies of certificates for radiation safety training of radiation employees.

7. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 13 of this Decree. Safety assessment reports shall conform to Form No. 11 under Annex V of this Decree.

8. Transport agreements if consignors are not carriers.

9. Accident response plans shall conform to Annex II of this Decree.

Article 27. Application for issuance of radiation-related affair permit – transit of radioactive substances, radioactive wastes, source materials and nuclear materials

1. Applications for issuance of radiation-related affair permit shall be made using Form No. 4 under Annex IV of this Decree.

2. Copies of written verification for juridical person of applicants.

3. Declarations of escorting employees using Form No. 02 under Annex III of this Decree.

4. Copies of certificates for radiation safety training of escorting employees.

5. Declarations of close and open radiation sources, radioactive wastes, source materials and nuclear materials using corresponding form under Annex III of this Decree.

Copies of certificates for radiation employees of employees specified under Point b and Point c Clause 1 Article 10 of this Decree. In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for issuance of radiation-related affair permit.

6. Safety assessment reports must satisfy all requirements specified under Clause 2 Article 13 of this Decree. Safety assessment reports shall conform to Form No. 11 under Annex V of this Decree.

7. Copies of transport agreements if consignors are not carriers.

8. Accident response plans shall conform to Annex II of this Decree.

Article 28. Entitlement for issuance of radiation-related affair permit and certificates for radiation employees

1. Ministry of Science and Technology shall issue radiation-related affair permit and certificates for radiation employees in cases other than those specified under Clause 2 of this Article.

2. People’s Committees of provinces shall issue permit for use of diagnostic X-ray devices in medical and certificates for radiation employees for safety personnel in medical diagnostic X-ray facilities in provinces. 

In case mobile diagnostic X-ray devices for medical use are employed in different provinces, People’s Committees of provinces where head offices of organizations and individuals possessing and managing the X-ray devices are situated shall issue permit for use of diagnostic X-ray devices in medical and certificates for radiation employees for safety personnel.

3. Competent agencies capable of issuing radiation-related affair permit have the rights to amend, extend and reissue radiation-related affair permit.

Article 29. Procedures for issuance of radiation-related affair permit

1. Implementation

a) Organizations and individuals shall apply for radiation-related affair permit (other than use of diagnostic X-ray devices in medical) by:

- Online at public service portal of Ministry of Science and Technology (excluding administrative procedures according to national single-window system and ASEAN single-window system);

- In person or via post service to Ministry of Science and Technology.

b) Organizations and individuals shall apply for radiation-related affair permit that includes the use of diagnostic X-ray devices in medical by:

- Online at public service portal of provinces;

- In person or via post service to public administration service centers or departments of reception and result return of agencies specialized in science and technology affiliated to People’s Committees of provinces.   

2. Application compositions

Compositions of applications for issuance of respective radiation-related affair permit are specified from Articles 15 to Article 27 of this Decree.

3. Application quantity: 1.

4. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications.

b) After receiving adequate applications and fees, competent agencies are responsible for organizing appraisal of applications and issuing permit using Form No. 2 under Annex VI of this Decree within:

- 15 days for import, export and transit;

- 25 days for diagnostic X-ray devices used in medical;

- 30 days for transportation;

- 45 days for other radiation-related affairs.

c) In case of not issuing radiation-related affair permit: Within the period specified under Point b of this Clause, competent agencies must respond in writing and specify reasons.

Article 30. Procedures for extending permit

1. Organizations and individuals shall submit applications to competent authorities within 45 days before permit that remains valid for more than 12 months expires or 15 days before permit that remains valid for 6 months or 12 months expires.  After the aforementioned deadlines, organizations and individuals must apply for new permit.

2. Implementation

Organizations and individuals shall submit application for extension of radiation-related affair permit to competent agencies capable of issuing the permit according to Clause 1 Article 29 of this Decree.

3. Application compositions

a) Applications for extension of permit using Form No. 6 under Annex IV of this Decree;

b) Copies of previously issued permit which is close of expire;

c) Personal dose rate measurement during valid period of permit requested for extension;

d) Copies of radiation monitoring results;

dd) Copies of assessment certificates for equipment (for use of radiation devices and operation of irradiators in medical);

e) Declarations for radiation employees or radiation safety personnel (in case of changes compared to the latest applications for permit issuance);

g) Radiation safety assessment reports using corresponding form under Annex V of this Decree (in case of changes compared to the latest applications for permit issuance).

4. Application quantity: 1.

5. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications.

b) After receiving adequate applications and fees, competent agencies are responsible for organizing appraisal of applications and issuing permit using Form No. 2 under Annex VI of this Decree within:

- 30 days for extension of permit that remains valid for more than 12 months;

- 25 days for extension of permit for use of diagnostic X-ray devices in medical;

- 15 days for extension of permit that remains valid for 12 months or 6 months.

c) In case of not extending radiation-related affair permit: Within the period specified under Point b of this Clause, competent agencies must respond in writing and specify reasons.

Article 31. Procedures for revising permit

1. Organizations and individuals must apply for permit revision in case of:

a) changes to information on organizations and individuals specified in permit such as name, address, phone number, fax number;

b) changes to information on import and export border checkpoints for import, export and transit permit; transport routes for transport and transit permit;

c) decrease in number of radiation sources or radiation devices in permit due to transfer, export, use cessation, and termination of operation or missing;

d) recalibration of information on radiation sources or radiation devices in case of any discrepancy between information on radiation sources or radiation devices in permit and in reality;

dd) changes to location of radiation-relate affairs for X-ray generators with self-shielding mechanisms for component analysis and product quality inspection, and for security screening devices;

e) multiple valid permits issued by a competent agency.

2. Implementation

Organizations and individuals shall submit application for revision of radiation-related affair permit to competent agencies by any method specified under Clause 1 Article 29 of this Decree.

3. Application compositions

a) Applications for revision of permit using Form No. 7 under Annex IV of this Decree;

b) Permit master registers;

c) Written confirmation of revised information in case of changes to name, address, phone number or fax number;

d) Copies of transfer agreements in case of decrease in radiation sources or radiation devices due to transfer; copies of export permit together with customs declarations in case of decrease in radiation sources due to export; written notice of facilities regarding use cessation or termination of operation; written confirmation for missing radiation sources radiation;

dd) Written documents proving discrepancy between information on radiation sources or radiation devices in issued permits and in reality and necessity for revision.

4. Application quantity: 1.

5. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications;

b) After receiving adequate applications and fees, competent agencies are responsible for organizing appraisal of applications and revise permit within 10 working days;

c) In case of not revising radiation-related permit: Within the period specified under Point b of this Clause, competent agencies must respond in writing and specify reasons.

Article 32. Procedures for adding to permit

1. Organizations and individuals must apply for permit addition in case of:

a) addition of new radiation sources or radiation devices;

b) addition of new radiation-related affair(s) except for those specified under Clause 2 of this Article;

c) increase of total activity for open radiation sources.

2. Cases in which addition to permit are not allowed:

a) import or export of radiation sources, source materials, nuclear materials and nuclear equipment;

b) transit of radiation sources, source materials and nuclear materials;

c) construction of radiation facilities;

d) termination of operation of radiation facilities;

dd) request for addition of new radiation-related affairs under competence of agencies other than agencies that have issued the permit.

3. Procedures:

Organizations and individuals shall submit application for addition to radiation-related affair permit to competent agencies by any method specified under Clause 1 Article 29 of this Decree.

4. Application compositions

a) Applications for addition to permit using Form No. 7 under Annex IV of this Decree;

b) Permit master registers;

c) Declarations of new radiation sources and radiation devices using corresponding form under Annex III of this Decree in case of addition of radiation sources and radiation devices; together with copies of manufacturers’ documents providing information specified under declarations;

d) Safety assessment reports for additional radiation-related affairs using corresponding form under Annex V of this Decree;

dd) Copies of certificates for radiation employees in case employees in charge of additional radiation-related affairs are required to obtain certificates for radiation employees according to Clause 1 Article 28 of Law on Atomic Energy.  In case the employees have not obtained certificates, submit applications for issuance of certificates for radiation employees according to Article 35 of this Decree and applications for addition to permit.

5. Application quantity: 1.

6. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications;

b) After receiving adequate applications and fees, competent agencies are responsible for organizing appraisal of applications and issuing additional permit using Form No. 2 under Annex VI of this Decree within:

- Deadline for appraising application for addition to radiation-related affairs for cases specified under Clause 1 Article 28 of this Decree shall be 30 days from the date on which adequate applications and fees are received;

- Deadline for appraising applications for addition to radiation-related affairs that involve use of diagnostic X-ray devices in medical shall be 25 days from the date on which adequate applications and fees are received. 

c) In case of rejecting addition to radiation-related permit: Within the period specified under Point c and Point d of this Clause, competent agencies must respond in writing and specify reasons.

Article 33. Procedures for reissuing permit

1. Organizations and individuals may apply for reissuance if their permits are damaged, torn or missing.

2. Implementation

Organizations and individuals shall submit application for reissuance of radiation-related affair permit to competent agencies according to Clause 1 Article 29 of this Decree.

3. Application compositions

a) Applications for reissuance of permit using Form No. 8 under Annex IV of this Decree;

b) Copies of master registers of damaged or torn permits (in case of damaged or torn permits).

4. Application quantity: 1.

5. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications;

b) After receiving adequate applications and fees, competent agencies are responsible for organizing appraisal of applications and issuing permit using Form No. 2 under Annex VI of this Decree;

c) Deadline for appraising applications for reissuance of radiation-related affair shall be 10 working days from the date on which adequate applications and fees are received;

d) In case of not issuing radiation-related permit: Within the period specified under Point c of this Clause, competent agencies must respond in writing and specify reasons.

Article 34. Procedures for declaration

1. Decentralization for declaration 

a) Organizations and individuals having radiation sources, radioactive wastes and radiation devices exceeding declaration exemption quota, source materials, nuclear materials and nuclear equipment shall declare to radiation and nuclear safety agencies affiliated to Ministry of Science and Technology, except for equipment specified under Point b of this Clause; 

b) Organizations and individuals having diagnostic X-ray devices for medical use shall declare to agencies specialized in science and technology affiliated to People’s Committees of provinces where the devices are utilized; with respect to mobile diagnostic X-ray devices for medical use utilized in at least 2 provinces and central-affiliated cities, declare to agencies specialized in science and technology affiliated to People’s Committees of provinces where head offices of organizations and individuals possessing and managing the devices are situated.

2. The procedures:

a) Declaration must be performed within 7 working days from the date on which organizations and individuals obtain radiation sources, radioactive wastes, radiation devices, source materials, nuclear materials and nuclear equipment;

b) Organizations and individuals shall declare for each radiation source, radioactive waste, radiation device, source material, nuclear material and nuclear equipment to competent agencies using corresponding form under Annex III of this Decree.

3. Deadline for resolution and result return

a) Within 5 working days from the date on which declarations are received, competent agencies are responsible for issuing verification of declaration using Form No. 1 under Annex VI of this Decree;

b) In case declarations are parts of applications for permit issuance, competent agencies may not issue verification for declaration.

4. Organizations and individuals exempted from declaration procedures in case of submission applications for issuance of radiation-related permit within the deadline specified under Clause 2 of this Article.

Article 35. Procedures for issuance of certificates for radiation employees

1. Implementation

a) Organizations and individuals shall apply for certificates for radiation employees by any of following methods:

- Online at website of Ministry of Science and Technology;

- In person or via post service to Ministry of Science and Technology.

b) Organizations and individuals shall apply for certificates for safety personnel of medical diagnostic X-ray facilities by any of following methods:

- Online at public service portal of provinces;

- In person or via post service to public administration service centers or departments of reception and result return of agencies specialized in science and technology affiliated to People’s Committees of provinces.  

2. Application compositions

a) Applications for issuance of certificates for radiation employees using Form No. 5 under Annex IV of this Decree;

b) Copies of specialized degrees and certificates corresponding to tasks;

c) Certificates for radiation safety training;

d) Medical check-up result sheets of medical facilities of districts or higher issued no more than 6 months before the date of submitting application for certificates for radiation employees;

dd) 3 3x4 cm photos in case of online or postal application; files for 3x4 cm photos in case of online application.

3. Application quantity: 1.

4. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications;

b) After receiving adequate applications and fees, competent agencies are responsible for organizing appraisal of applications and issuing certificates for radiation employees using Form No. 3 under Annex VI of this Decree;

c) Deadline for appraising applications and issuing certificates for radiation employees shall be 10 working days from the date on which adequate applications and fees are received;

d) In case of not issuing certificates for radiation employees: Within the period specified under Point c of this Clause, competent agencies must respond in writing and specify reasons.

Article 36. Procedures for facility-level approval of accident response plans

1. Competent agencies capable of approving accident response plans shall be competent agencies capable of issuing radiation-related permit specified under Article 28 of this Decree.

2. Procedures for requesting approval of accident response plans

a) Administrative procedures

Organizations and individuals shall request for approval of accident response plans by any of following methods:

- Online at website of competent agencies specified under Clause 1 of this Article;

- Online or via post service to competent agencies specified under Clause 1 of this Article.

b) Application compositions:

- Official Dispatches requesting approval of accident response plans;

- Accident response plans shall be prepared conforming to Annex II of this Decree.

c) Application quantity: 3 (in case of online or postal application).

d) Deadline for resolution and result return

- Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications;

- Within 15 days from the date on which adequate applications and fees for approval of accident response plans are received, competent agencies are responsible for organizing appraisal of applications and issuing decisions on approving accident response plans;

- In case of not approving accident response plans, before this deadline, competent agencies must respond in writing and provide reasons.

3. In case request for approval of facility-level accident response plans are submitted together with application for permit issuance: Deadline for processing the request shall conform to deadline for processing applications for radiation-related affair permit.

Article 37. Duration of radiation-related affair permit and certificates for radiation employees

1. Radiation-related affair permit shall remain valid for:

a) 12 months for: Import and export of class 4 and class 5 radiation sources according to QCVN 6:2010/BKHCN (issued to each shipment of close radiation sources and to multiple shipments for open radiation sources).

b) 6 months for: Import and export of class 1, class 2 and class 3 radiation sources according to QCVN 6:2010/BKHCN, nuclear materials and nuclear equipment (issued to each shipment).

c) 6 months for: Transit of radiation sources, source materials and nuclear materials.

d) 5 years for operation of irradiators.

dd) 03 years for other radiation-related affairs.

2. Certificates for radiation employees shall last indefinitely.

3. Duration of extended permits shall continue from the expiry date of old permits.

4. Duration of revised, added or reissued permits shall be similar to that of old permits, except for cases specified under Clause 5 of this Article.

5. Duration of permits that are revised to unify previously issued permits that are valid shall be similar to duration of the latest issued permits.

Chapter III

AUXILIARY SERVICES FOR ATOMIC ENERGY APPLICATION

Section 1. ELIGIBILITY FOR ISSUANCE OF REGISTRATION FOR AUXILIARY SERVICES FOR ATOMIC ENERGY APPLICATION

Article 38. Radiation and nuclear technical and technology advice; radiation technology and nuclear technology assessment and appraisal

1. Having written materials, methods, technical procedures and documents on capacity for providing services.

2. Having programs for guaranteeing and controlling quality of technical and technology advice services in atomic energy sector, radiation and nuclear technology assessment services; having management systems and operational capacity satisfactory to National Standards TCVN ISO/IEC 17020:2012 or International Standards ISO/IEC 17020:2012 or national, international standards on specialized appraisal for radiation and nuclear technology appraisal service.

Article 39. Radiation monitoring

1. Having radiation dose rate meters which are under calibration certificates that remain valid for at least 30 days from the date on which applications are received.

2. In case of measuring radiation contamination to surface and air: Having surface and air radiation contamination measuring instrument which is under calibration certificates that remain valid for at least 30 days from the date on which applications are received.

3. Having personal dose rate meters and protective gears for employees to protect from external exposure.   In case service provision includes contact with open radiation sources, protective gears for employees to protect from internal exposure.

4. Having programs for guaranteeing service quality.

Article 40. Radioactive decontamination

1. Having tools, chemicals and materials for radioactive decontamination.

2. Satisfying requirements specified under Article 39 of this Decree;

Article 41. Radioactivity assessment

1. Having equipment for identifying radioactive isotopes.

2. In case of assessing activity of specimen: Having standard specimen, specimen processing systems and specimen analysis equipment suitable for assessed radioactive isotopes.

3. Satisfying requirements specified under Article 39 of this Decree;

Article 42. Installation, maintenance and repair of radiation devices

1. Satisfying requirements specified under Points a, b, c, d, and h Clause 2 Article 5 of this Decree.

2. Having hot cells or shielding equipment for when interacting with radiation sources.

3. Having adequate equipment to provide services.

4. Satisfying requirements specified under Article 39 of this Decree.

Article 43. Measurement of personal exposure

1. Having corresponding personal exposure meters, personal dosimeters and measurement results satisfactory to standard dose rate. 

2. Having storage rooms and personal exposure measurement rooms conforming to guidelines of manufacturers of personal exposure meters. 

3. Satisfying requirements specified under Clause 4 Article 39 of this Decree.

Article 44. Radiation device inspection

1. Having equipment and tools serving radiation device inspection conforming to corresponding National Technical Regulations on radiation device inspection. In case of radiation devices that are not prescribed by National Technical Regulations on inspection, may apply guiding documents of manufacturers of equipment for inspecting the radiation devices.

2. Satisfying requirements specified under Clause 1, Clause 3 and Clause 4 Article 39 of this Decree.

Article 45. Radiation gauge calibration

1. Having standard radiation sources and radiation devices calibrated in standard rooms for radiation measurement, national or international nuclear measurement.

2. Having standard rooms for calibration of radiation gauges which satisfy following requirements:

a) Shielding mechanisms must assure radiation safety for radiation employees, the general public and ensure that calibration is not affected by environmental radiation;

b) Temperature and humidity control systems must be installed to guarantee calibration quality;

c) In case room design or guidelines on room dimension of suppliers of standard equipment or sources are not available, ensure minimum dimension of standard rooms according to Annex VII of this Decree. 

3. Satisfying requirements specified under Clause 1, Clause 3 and Clause 4 Article 39 of this Decree.

Article 46. Radiation device experimentation

1. Having rooms for experimenting radiation devices that satisfy following requirements:

a) Shielding mechanisms must assure radiation safety for radiation employees and the general public;

b) Experiments must not be conducted simultaneously along other activities.

2. Satisfying requirements specified under Points a, b, c, d, and h Clause 2 Article 5 of this Decree.

3. Satisfying requirements specified under Clause 1, Clause 3 and Clause 4 Article 39 of this Decree.

Article 47. Radiation safety training; speciality and operation training

1. Having teaching programs and materials satisfactory to radiation-related affairs applied for permit. Teaching programs and materials must fully convey regulations and law, techniques and practice exercises according to Ministry of Science and Technology.

2. Having technical equipment serving lecture and practice sessions.

3. Having programs for guaranteeing service quality.

Section 2. ELIGIBILITY FOR ISSUANCE OF PRACTICE PERMIT OF AUXILIARY SERVICES FOR ATOMIC ENERGY APPLICATION

Article 48. General eligibility for issuance of practice permit of auxiliary services for atomic energy application

1. Having specialized knowledge and working experience suitable for each form of services specified under Article 49, Article 50 and Article 51 of this Decree.

2. Having certificates for specialized training issued by training facilities which are permitted by competent agencies for forms of services from Point a to Point k Clause 3 Article 1 of this Decree.

In case training facilities permitted by competent agencies are not available in Vietnam, satisfy any of following requirements:

- Having certificates issued by overseas agencies and organizations for specialized training suitable for forms of services applied for permit;

- Having participated in developing legislative documents, national technical regulations and national technical standards on forms of services applied for permit.

3. Having experience in teaching or teaching assistance at training facilities for forms of services specified under Point l Clause 3 Article 1 of this Decree.

Article 49. Radiation and nuclear technical and technology advice; radiation technology and nuclear technology assessment and appraisal

1. In case of provision of radiation and nuclear technical and technology advice services: Having at least university degrees in technical major suitable for forms of services provided and having at least 5 years of experience in atomic energy. 

2. In case of provision of radiation and nuclear technology assessment services: Having at least university degrees in training major suitable for technologies to be assessed and at least 5 years of experience in technologies to be assessed. 

3. In case of provision of radiation and nuclear technology assessment services: Having at least university degree in training major suitable for technologies to be assessed, receiving training regarding National Standards TCVN ISO/IEC 17020:2012 or International Standards ISO/IEC 17020:2012 or national, international standards on specialized assessment and at least 5 years of experience in technologies to be assessed. 

Article 50. Radiation monitoring, radioactive decontamination, radioactivity assessment, installation, maintenance, repair of radiation devices, personal exposure meters, inspection of radiation devices, calibration of radiation gauges or radiation device experimentation

1. In case of provision of radioactive decontamination and calibration of radiation gauge services: Having at least university degrees in majors related to nuclear physics, radiation technology, nuclear technology and at least 5 years of experience in atomic energy.

2. In case of provision of radiation monitoring, radioactivity assessment, installation, maintenance, repair of radiation devices, personal exposure meters, inspection of radiation devices or experimentation of radiation devices: Having at least college degrees in technical majors suitable for forms of services provided and at least 3 years in atomic energy.

Article 51. Radiation safety training; speciality and operation training

1. In case of provision of radiation safety training service:

a) Regarding technical contents: Having at least university degrees in majors related to nuclear physics, radiation technology, nuclear technology and at least 5 years of experience in radiation safety;

b) Regarding legal contents: Having at least university degrees in any major related to law and majors related to nuclear physics, radiation technology, nuclear technology and at least 5 years of experience in radiation safety.

2. In case of provision of specialized training service regarding radiation and nuclear technical and technology advice; assessment and inspection of radiation and nuclear technology: Having at least university degrees in majors related to nuclear physics, radiation technology, nuclear technology or technical majors suitable for forms of services provided and at least 5 years of experience in training contents.

3. In case of provision of specialized training service regarding radiation monitoring, radioactive decontamination, assessment of radioactivity, measurement of personal exposure or calibration of radiation gauges: Having at least university degrees in majors related to nuclear physics, radiation technology, nuclear technology and at least 5 years of experience in training contents.

4. In case of provision of specialized training service regarding installation, maintenance, repair of radiation devices, inspection of radiation devices or experimentation of radiation devices: Having at least university degrees in technical majors and at least 5 years of experience in training contents. 

Section 3. PROCEDURES FOR ISSUANCE OF REGISTRATION FOR OPERATION AND PRACTICE PERMIT OF AUXILIARY SERVICES FOR ATOMIC ENERGY APPLICATION

Article 52. Procedures for issuance of registration for auxiliary services for atomic energy application

1. Implementation

Organizations shall apply for issuance of registration for provision of auxiliary services for atomic energy application by:

a) online on public service portal of Ministry of Science and Technology;

b) in person or via post service to Ministry of Science and Technology.

2. Application compositions

a) Applications for issuance of registration for operation using Form No. 9 under Annex IV of this Decree;

b) Copies of any of following documents: Decisions on organization establishment, enterprise registration certificates, investment registration certificates, certificates for science and technology activities and other equivalent documents. In case documents are lost, certification of issuing agencies or reissuance of said documents is required;

c) Declarations of employees providing services using Form No. 15 under Annex III of this Decree together with copies of employment decisions or employment contracts between applicants and the employees providing services; 

d) Copies of practice permit corresponding to forms of services of employees providing services;

dd) Declarations of equipment serving respective services using Form No. 16 under Annex III of this Decree (applicable to services specified from Point c to Point l Clause 3 Article 1 of this Decree);

e) Safety analysis reports using Form No. 12 under Annex V of this Decree (applicable to services specified from Point c to Point l Clause 3 Article 1 of this Decree);

g) Copies of agreements for personal exposure reading service of employees providing services (applicable to services specified under Points c, d, dd, e, h, i, and k Clause 3 Article 1 of this Decree);

h) Facility-level response plans for radiation accidents (applicable to services specified under Point e and Point k Clause 3 Article 1 of this Decree);

i) Training programs and teaching materials (applicable to services specified under Point l Clause 3 Article 1 of this Decree);

k) Copies of radiation-related affair permit for affairs that involve the use of radioactive substances and radiation devices for cases in which organizations employ radioactive substances and radiation devices in a manner that exceeds the limit for exemption from declaration and licensing according to National Technical Regulations QCVN5:2010/BKHCN during service provision;

l) Other documents proving facility and technical capacities satisfying requirements of forms of services according to this Decree.

3. Application quantity: 1.

4. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications;

b) Within 30 days from the date on which adequate applications and fees are received, competent agencies are responsible for organizing appraisal of applications and issuing registration for service provision using Form No. 4 under Annex VI of this Decree;

c) In case of not issuing registration for service provision: Within the period specified under Point b of this Clause, competent agencies must respond in writing and specify reasons.

Article 53. Procedures for extension of registration of auxiliary services for atomic energy application

1. Organizations must apply for extending registration for operation at least 45 days before the registration expires. After this deadline, organizations must apply for new registration.

2. Implementation

Organizations shall apply for extension according to Clause 1 Article 52 of this Decree.

3. Application compositions

a) Applications for extension of registration for operation using Form No. 10 under Annex IV of this Decree;

b) Declaration for addition and update in case of changes to employees providing services; Service practice permit corresponding to forms of services of employees providing services;

c) Copies of previously issued registration which is close to expire;

d) Personal exposure results of employees providing services (in case of services that require the use of personal exposure meters).

4. Application quantity: 1.

5. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications;

b) Within 30 days from the date on which adequate applications and fees are received, competent agencies are responsible for organizing appraisal of applications and extending registration for service provision using Form No. 4 under Annex VI of this Decree;

c) In case of not extending registration for service provision: Within the period specified under Point b of this Clause, competent agencies must respond in writing and specify reasons.

Article 54. Procedures for revision of registration for operation

1. Organizations must request revision of registration for operation in case of changes to information on the organizations specified on the registration such as name and address of the organizations.

2. Implementation

Organizations shall apply for revision according to Clause 1 Article 52 of this Decree.

3. Application compositions

a) Applications for revision of registration for operation using Form No. 11 under Annex IV of this Decree;

b) Master registers of registration for operation applied for revision;

c) Documents proving or verifying revised information.

4. Application quantity: 1.

5. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications;

b) Within 5 days from the date on which adequate applications and fees are received, competent agencies are responsible for organizing appraisal of applications and issuing registration for service provision using Form No. 4 under Annex VI of this Decree.

c) In case of not issuing revised registration for service provision: Within the period specified under Point b of this Clause, competent agencies must respond in writing and specify reasons.

Article 55. Procedures for reissuance of registration for operation

1. Organizations must apply for reissuance of registration for operation in case the registration is damaged, torn or missing.

2. Implementation

Organizations shall apply for reissuance according to Clause 1 Article 52 of this Decree.

3. Application compositions

a) Applications for reissuance of registration for operation using Form No. 12 under Annex IV of this Decree;

b) Master registers of registration for operation (in case of reissuance due to damaged, torn or missing registration).

4. Application quantity: 1.

5. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications;

b) Within 5 working days from the date on which adequate applications and fees are received, competent agencies are responsible for organizing appraisal of applications and reissuing registration for service provision using Form No. 4 under Annex VI of this Decree;

c) In case of not reissuing registration for service provision: Within the period specified under Point b of this Clause, competent agencies must respond in writing and specify reasons.

Article 56. Procedures for issuance of practice permit of auxiliary services for atomic energy application

1. Implementation

Organizations and individuals shall apply for issuance of practice permit of auxiliary services for atomic energy application according to Clause 1 Article 52 of this Decree.

2. Application compositions

a) Applications for issuance of practice permit using Form No. 13 under Annex IV of this Decree;

b) Personal information sheet using Form No. 17 of Annex III of this Decree;

c) Copies of any of following valid documents: ID cards, citizen identity cards or passports;

d) Copies of specialized degrees and certificates according to this Decree suitable for form of services applied for permit issuance;

dd) Documents proving working experience suitable for forms of services applied for permit issuance. Individuals applying for issuance of practice permit for radiation safety training service or specialized training must obtain written confirmation of teaching and teaching assistance experience of training organizations;

e) 3 3x4 cm portrait photos in case of online or postal application; files for 3x4 cm photos in case of online application (photos format eligible for citizen identity cards, ID cards or passports).

3. Application quantity: 1.

4. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications;

b) Within 30 days from the date on which adequate applications and fees are received, competent agencies are responsible for organizing appraisal of applications and issuing practice permit using Form No. 5 under Annex VI of this Decree;

c) In case of not issuing practice permit: Within the period specified under Point b of this Clause, competent agencies must respond in writing and specify reasons.

Article 57. Procedures for reissuance of practice permit

1. Implementation

Organizations and individuals shall apply for reissuance of practice permit of auxiliary services for atomic energy application according to Clause 1 Article 52 of this Decree.

2. Application compositions

a) Applications for reissuance of practice permit using Form No. 14 under Annex IV of this Decree;

b) Master registers of practice permit (In case of reissuance due to torn or damaged permit).

3. Application quantity: 1.

4. Deadline for resolution and result return

a) Within 5 working days from the date on which applications are received, application receivers must examine adequacy and legitimacy of applications and inform fees in writing in case of adequate applications or request revision in writing in case of inadequate applications;

b) Within 5 days from the date on which adequate applications and fees are received, competent agencies are responsible for organizing appraisal of applications and reissuing practice permit using Form No. 5 under Annex VI of this Decree;

c) In case of not issuing practice permit: Within the period specified under Point b of this Clause, competent agencies must respond in writing and specify reasons.

Article 58. Entitlement for issuance and duration of registration and practice permit

1. Ministry of Science and Technology shall issue, reissue and revise registration and practice permit of auxiliary services for atomic energy application.

2. Duration of registration for operation and practice permit of auxiliary services for atomic energy application:

a) Registration for provision of radiation safety service shall last indefinitely. Registration for provision of other services shall last 5 years;

b) Registration that has been revised and reissued shall have the same duration as the original registration;

c) Permit for provision of auxiliary services for atomic energy application shall last indefinitely.

Chapter IV

IMPLEMENTATION

Article 59. Responsibilities of ministries and ministerial agencies

1. Ministry of Science and Technology is responsible for guiding and organizing management of implementation of radiation-related affairs and provision of auxiliary services for atomic energy application; inspecting and examining implementation of responsibilities of relevant agencies, organizations and individuals specified under this Decree. 

2. Ministry of Health is responsible for providing specific guidelines on training facilities, training programs, contents and medical physics degrees and certificates.

3. Ministries, ministerial agencies and Governmental agencies, within their tasks and powers, are responsible for cooperating with Ministry of Science and Technology in guiding, expediting and examining implementation of this Decree within fields assigned by the government.

Article 60. Responsibilities of People’s Committees of provinces

1. Publicizing and implementing this Decree in local administrative divisions.

2. Science and technology agencies affiliated to People’s Committees of provinces are responsible for assisting Chairpersons of People’s Committees of provinces in implementing tasks specified under Clause 1 of this Article.

Article 61. Responsibilities of organizations and individuals conducting radiation-related affairs and providing auxiliary services for atomic energy application

1. Stringently and adequately implementing this Decree.

2. Complying with requirements of competent authorities during appraisal for issuance of radiation-related affair permit and issuance of registration for provision of auxiliary services for atomic energy application.

3. Fully assigning human resources, equipment and financial sources to assure satisfaction of requirements for implementation of radiation-related affairs, requirements for provision of auxiliary services for atomic energy application according to this Decree.

Chapter V

IMPLEMENTATION

Article 62. Entry into force

1. This Decree comes into force from February 1, 2021.

2. Organizations and individuals issued with radiation-related permit, registration for provision of auxiliary services for atomic energy application may operate until said permit and registration expire.

3. Organizations and individuals which have applied but have not received radiation-related affair permit, certificates for radiation employees, registration for provision of auxiliary services for atomic energy application or permit for provision of auxiliary services for atomic energy application before the effective date hereof must revise their applications according to this Decree.

4. Medical physics training requirements applied to nuclear medicine facilities and radiotherapy facilities shall begin from February 1, 2026.

5. If technical regulations and technical standards referred to in this Decree are approved for amendments or replaced, the new versions will prevail.

Article 63. Responsibilities for implementation

Ministers, heads of ministerial agencies, heads of Governmental agencies, Chairpersons of People’s Committees of provinces and relevant agencies, organizations, individuals are responsible for implementation of this Decree./.