Tiếng Việt- 1 Joint circular No. 2237/1999/TTLT-BKHCNMT-BYT of December 28, 1999 guiding the implementation of medical radiation safety
- 2 Circular No. 14/2003/TT-BKHCN of July 11th, 2003, guiding on radiation transportation safety.
- 3 Circular No. 05/2006/TT-BKHCN of January 11, 2006, guides on declaration and authorization issuance of radiation-related practice
| THE GOVERNMENT | SOCIALIST REPUBLIC OF VIET NAM |
| No. 50/1998/ND-CP | Hanoi, July 16, 1998 |
DETAILING THE IMPLEMENTATION OF THE ORDINANCE ON RADIATION SAFETY AND CONTROL
GOVERNMENT
Pursuant to the Law on Organization of the Government of September 30, 1992;
Pursuant to the Ordinance on Radiation Safety and Control of June 25, 1996;
At the proposal of the Minister of Science, Technology and Environment,
DECREES:
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Article 3.- Terms used in this Decree shall be construed as follows:
1. Activity means the variable of self-radiating nuclei of the radioactive substance per second. The measuring unit is Becquerel (Bq).
2. Natural radiation background means radiations originating from natural sources (such as radiation from the universe, from natural radiating nuclei existing in earth and rock, air, water, human and animal bodies, materials, etc.)
3. Irradiation is the radiation effect on a part or the whole of a human or animal body or any object.
4. Radiation dose means the quantity of radiation measured at a certain location.
5. Internal exposure means the radiation dose irradiated by radioactive substances infiltrating into the body (through food, drink, air).
6. External exposure means the radiation dose irradiated by radioactive sources outside the body.
7. Personal dose is the radiation dose calculated separately for each individual.
8. Collective dose is the radiation dose calculated for a collective of people subject to an equal average dose.
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10. Over-exposure means the irradiation which goes beyond the dose limit.
11. Acute effect is the harmful effect which occurs after a short period of time when being irradiated with a high dose.
12. Decontamination is the process of getting rid of or reducing the unclean radioactive substances inside or on the objects to the allowable level.
13. Dosemeter is the equipment or machine used to measure the radiation dose, the activity of radiation sources, to determine the radioactive isotopes, etc.
14. Personal dosemeter is equipment used for measurement of personal radiation dose.
15. Radiation alarm instrument is the equipment or machine which emits signal notifying that the radiation dose has exceeded a certain level, which may cause danger to human health.
16. Calibration means the comparision between meters and the standard meter or standard radiation source in order to rectify errors and ensure the reliability of the measurement by the meters.
17. Radiation monitoring means the control of radiation dose and/or activity so as to detect in time the change in radiation dose and radioactive waste.
18. Radiation control area means the area where appropriate radiation safety measures (such as restriction on exits or entries, personal radiation monitoring, special health monitoring...).
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RESPONSIBILITIES TO ENSURE RADIATION SAFETY
In cases where the owner doesn't manage the radiation establishment, his/her representative at law shall be the manager of the radiation establishment.
In cases where the owner is not the manager of the radiation establishment and does not have the lawful representative, the lawful user of the establishment shall be its manager.
2. The radiation establishment manager shall take the highest responsibly to ensure the radiation safety for his/her establishment and employees, the population and environment in surrounding areas, shall apply appropriate measures in order to keep radiation at the possible reasonably low level with economic and social factors being taken into account, which must not exceed the prescribed limit.
3. The Ministry of Science, Technology and Environment shall study and submit necessary amendments to the provisions of the Ordinance on Radiation Safety and Control regarding the radiation establishment manager's powers.
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Depending on the establishment's activity scale, the manager shall set up an appropriate radiation safety section.
2. The radiation establishment manager shall set up a radiation incident prevention and combat team suitable to the activity scale of the establishment. This team shall be provided with necessary equipment and regular training.
2. Persons aged under 18, who are probationers or apprentices, shall be allowed to work only in the radiation control areas under the guidance of instructors.
2. The radiation establishment manager shall have to submit the annual report on radiation safety status at his/her establishment to the Ministry of Science, Technology and Environment and to his/her immediate high-level agency.
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1. Organize the medical examination when recruiting radiation personnel.
2. Monitor the radiation personnel's health and organize medical examinations for them once every 6 months as stipulated by the Ministry of Health.
3. Provide the radiation personnel with protective means, personal dosemeters and compel them to use such equipment while performing radiation work.
4. Make the assessment of personal dose for radiation personnel at least once every 3 months at the institutions designated by the State management agency in charge of radiation safety and control under the Ministry of Science, Technology and Environment.
5. Keep the records on the radiation personnel's medical check-ups and personal does for 30 years after they move to perform non-radiation jobs or retire. In cases where the establishment has its license withdrawn, its manager shall still have to retain all the above-mentioned dossiers. In cases where the establishment dissolves, goes bankrupt or terminates its operation, the above-said dossiers must be handed over to radiation personnel.
2. When a radiation worker is exposed to a dose beyond the annual dose limit, the manager shall have to:
a/ Send him/her to a specialized medical institution for examination and health monitoring;
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c/ Assign him/her appropriate work in order to keep the personal dose below the prescribed limit.
3. When a female radiation worker is in the pregnancy or nursing period, the manager shall have to assign her any non-radiation job.
2. Any important radiation establishment having accelerator, nuclear reactor, industrial irradiator, teletherapy... must be equipped with the radiation alarm instrument.
3. Any radiation establishment with low radiation danger which can not equip itself with a dosemeter, shall have to use the radiation monitoring services.
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1. The manager shall have to:
a/ Send a report thereon to his/her direct managing agency and the State management agency in charge of radiation safety and control under the Ministry of Science, Technology and Environment, enclosed with the following documents:
- The inventory of radiation apparatus, radioactive sources, radioactive substances, radioactive waste according to inventory forms specified by the Ministry of Science, Technology and Environment;
- The plan for settling the radiation apparatus, radioactive sources, radioactive substances, radioactive waste.
b/ To hand over the health and personal dose records to radiation personnel;
c/ To ensure the radiation safety until being recognized as having been out of any responsibility by the State management agency in charge of radiation safety and control under the Ministry of Science, Technology and Environment.
2. The direct managing agency shall have to direct and supervise the radiation establishment manager in applying necessary measures to ensure the radiation safety until the establishment is recognized as having been out of any responsibility.
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a/ Consider and approve the plan submitted by the manager;
b/ Organize the evaluation of the safe handling of radiation apparatus, radioactive sources, radioactive substances, radioactive waste and radiation establishment;
c/ Recognize by a decision that the radiation establishment will be out of any responsibility for ensuring the radiation safety.
2. The Ministry of Science, Technology and Environment shall specify other dose limits.
RESPONSIBILITIES FOR HANDLING RADIATION INCIDENT
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Level 1. Unexpected radiation incident is an incident which occurs when:
1. The apparatus operates beyond the prescribed operating regime;
2. Considerable damage is caused to the safety system; radioactive release spreads in the establishment; personnel are over-exposed to radiation.
Level 2. Serious radiation incident is an incident which occurs when:
1. The safety systems are no longer effective; the establishment is subject to serious radioactive contamination radiation personnel's health is acutely affected;
2. Off-site radioactive release has exposed many persons to a personal radiation dose of up to 1 mSv.
Level 3. A particularly serious radiation incident:
1. A particularly serious radiation incident posing no considerable danger to areas outside the establishment is a radiation incident which occurs when:
a/ The reactor core or safety system is considerably damaged; radiation personnel are exposed to a fatal dose;
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2. A particularly serious radiation incident causing considerable danger to the outside of the establishment is a radiation incident which occurs when:
a/ The reactor core or safety systems is seriously damaged; radiation workers are exposed to a fatal dose;
b/ External radioactive release has exposed many people to a personal radiation dose of 10 mSv or more.
Article 19.- When a radiation incident occurs, the radiation establishment manager shall have to:
1. Quickly locate the incident site, assess its causes, characteristics and development in order to apply remedial measures according to the drawn-up plan:
a/ If the incident is at level 1, manpower and means in the establishment must be quickly mobilized so as to overcome the incident and seek ways to check it from spreading, to minimize possible consequences, to provide the first-aid to overexposed victims, to isolate the danger area, to monitor the development of the incident, to continuously control the radiation doses, to make report and submit it to his/her direct managing agency and the State management agency in charge of radiation safety and control under the Ministry of Science, Technology and Environment. If he/she deems incapable of overcoming the incident, he/she must report immediately to the higher-level agencies for timely support. Pending the support, he/she must continue organizing the handling of the incident and constantly inform such agencies thereof.
b/ If the incident is at level 2, he/she must immediately notify the incident site to the State management agency in charge of radiation safety and control under the Ministry of Science, Technology and Environment, his/her direct managing agency, the People's Committees of district/provincial town (hereafter referred collectively to as the district level) and of province/city directly under the Center Government (hereafter referred collectively to as the provincial level), where the incident occurs so as to get timely assistance and, depending on the seriousness of the incident, to let the People Committee of the district or provincial level notify the local population thereof; to overcome the event as specified for the level 1; to evacuate personnel from the establishment if necessary; to isolate the entire establishment and maintain strict security, if the radiation danger widely spreads.
c/ If the incident is at level 3, he/she must quickly act as specified for level 2 incident; propose to the competent authorities to evacuate local population from dangerous areas if he/she deems necessary and take measures for the strict management of the environment.
2. Create favorable conditions for functional bodies to participate in overcoming the incident and to follow their instructions.
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4. To submit detailed report on the incident to his/her direct managing agency, the State management agency in charge of radiation safety and control under the Ministry of Science, Technology and Environment, the Ministry of Labor, War Invalids and Social Affairs, the People's Committee of the province where the radiation incident occurred. In case of urgent situation, the manager may report by phone, but shall later have to make a written report for files keeping.
Content of the initial urgent report includes:
- Full name, position of report maker;
- Name of the radiation establishment, full and exact address of the incident site;
- Time when the incident occurred;
- Important developments in the radiation incident area;
- Predictive cause of the incident;
- Full name, telephone number of the manger of the establishment where the incident occurred.
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2. Upon receiving the urgent report on radiation incident, the Ministry of Science, Technology and Environment shall establish a steering board for overcoming the incident, consisting of competent representatives of relevant ministries, branches and localities, to be led by the Ministry of Science, Technology and Environment. This ministry shall send the emergency team and experienced experts to help the establishment overcome the incident; and at the same time appoint competent officials to monitor the incident and keep constant contact with the establishment in order to grasp the situation and to pass necessary instructions.
3. The steering board and emergency team shall be given full powers and priority in using the quickest transport means while performing their duty.
4. In case of a particularly serious radiation incident, the Ministry of Science, Technology and Environment shall have to promptly report in detail to the Prime Minister for instruction.
5. The Ministry of Science, Technology and Environment shall have to provide official information on the radiation incident to the mass media.
6. The Ministry of Science, Technology and Environment shall organize the implementation of international agreements relating to radiation incident which Vietnam has signed or acceded to.
7. The Ministry of Science, Technology and Environment shall have to study and elaborate the provisions on settling the consequences of radiation incidents which shall be submitted to the Government for further submission to the National Assembly Standing Committee for supplement to the Ordinance on Radiation Safety and Control.
Article 21.- Upon receiving an urgent report on radiation incident:
1. The ministry, branch and agency which directly manages the establishment shall have to:
a/ Immediately send specialists to the establishment, helping it overcome the incident;
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2. The Ministry of Health shall have to:
a/ Give first-aid to the victims in time;
b/ Examine and monitor the health of persons who are affected by the incident.
3. The Ministry of Public Security shall have to:
a/ Immediately send competent officials to the establishment to help it overcome the incident and maintain security in the area;
b/ Coordinate with the Ministry of Science, Technology and Environment in investigating the cause of the incident; in case of an act of sabotage or negligence of responsibility, thus causing serious damage, to compile dossiers to examine for penal liability.
4. The Ministry of Labor, War Invalids and Social Affairs shall have to send State labor inspectors to the establishment for coordinating with radiation safety inspectors of the Ministry of Science, Technology and Environment in investigating cases of labor accident relating to radiation, which have caused death or serious radiation overexposure to radiation personnel.
5. The district/provincial People's Committees shall have to:
a/ Immediately send competent officials to help the establishment overcome the incident;
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The Ministry of Science, Technology and Environment shall urgently notify the incident to the People's Committee of the province where the incident occurred, which shall assume the prime responsibility and coordinate with the Ministry of Science, Technology and Environment as well as relevant agencies in evacuating the local population from the dangerous areas.
The Ministry of Health shall decide to allow or not allow the use of food, foodstuffs and drinking water in areas affected by the radiation incident;
The Ministry of Defense shall mobilize resources for overcoming the incident.
DECLARATION, GRANTING OF REGISTRATION PAPERS AND LICENSES
The dossiers of application for registration papers shall be submitted to the State management agency in charge of radiation safety and control under the Ministry of Science, Technology and Environment.
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- The application for registration paper(s);
- The declaration;
- Copy of the record of radioactive sources/or radiation equipment.
The dossiers of application for licenses shall be submitted to the State management agency in charge of radiation safety and control under the Ministry of Science, Technology and Environment; for cases specified in Clause 2 of Article 35 of this Decree, the dossiers shall be submitted to the Ministry of Health.
Such a dossier shall include:
- The application for licenses;
- The declaration;
- The written evaluation of radiation safety and environment impact regarding radiation safety;
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- Copy of the decision on establishing the radiation establishment.
Such a dossier shall include:
- The application for license to perform special radiation work;
- Copies of diploma, appropriate professional certificates;
- Health certificate.
2. The special radiation work specified in Clause 1, Article 24 of the Ordinance on Radiation Safety and Control shall include:
- Installation, operation, repairing, overcoming failure of nuclear reactor, accelerator, teletherapy, semi-industrial or industrial irradiator, industrial scanner;
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- Decontamination and overcoming radiation incidents of from level-2 upward, as defined in Article 18 of this Decree, for areas of radioactive contamination.
Article 28.- The term of a license is stipulated as follows:
1. Establishment using nuclear reactor, accelerator, multipurpose irradiation facilities including radiation therapy: 5 years
2. Other radiation establishments: 3 years
3. Employees carrying out special radiation work: 3 years
4. Radiation work not defined in Clauses 1 and 2 of this Article: the term shall be determined appropriately according to types of work.
A dossier of application for license extension shall include:
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- The written evaluation of radiation safety of the establishment during the licensed term, especially concerning radiation incidents and remedial measures.
Such a dossier shall include:
- The application for the license to upgrade, expand the scope and purpose of operation of the radiation establishment beyond the license stipulations (or to upgrade the radiation facility);
- Project for upgrading, expanding the operation scope and purpose (or upgrading radiation safety);
- Radiation safety report;
- The written evaluation of environment impact regarding radiation safety when putting the establishments or the facility into operation.
2. For radiation establishments and facilities mentioned in Clause 1 of this Article, the manager of the radiation establishment shall fulfil the procedures to apply for the amendment to the license or for new registration paper.
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- The application for amendment to the license or for new registration paper;
- The report on test and acceptance regarding radiation safety for items mentioned in Clause 1 of this Article.
2. The Ministry of Finance shall, in cooperation with the Ministry of Science, Technology and Environment, determine the amount of fees and charges to be paid by for organizations and/or individuals mentioned in Clause 1 of this Article, and stipulate the management and use of such fees and charges.
1. Organizations and/or individuals that are no longer qualified or violate the radiation safety regulations causing damage to people and environment, violates conditions specified in licenses but fail to rectify it within the timelimit specified in the notice of the State management agency in charge of radiation safety and control under the Ministry of Science, Technology and Environment. Such timelimit shall not exceed 30 days.
2. The radiation establishment dissolves or goes bankrupt.
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STATE MANAGEMENT RESPONSIBILITY FOR RADIATION SAFETY AND CONTROL
a/ To draft legal documents on radiation safety and control and the system of radiation safety standards, and submit them to the Government for promulgation, or promulgate by itself according to its competence;
b/ To draw up and submit to the Government plans an radiation safety and control;
c/ To organize the declaration, issuance of registration papers and licenses, the extension, amendment and withdrawal of registration papers and licenses for radiation establishments, radioactive sources and radiation work in the fields of industry, agriculture, health service, education, construction, communication and transport, national defense, police... according to the provisions in the Chapter IV of this Decree; to instruct on the conditions in the cases of exemption of declaration, exemption of registration papers and exemption of license; to instruct on the contents, procedures, dossiers and forms related to declaration, registration and licensing;
d/ To organize the evaluation of radiation safety before granting registration papers and/or licenses, the extension and/or amendment of registration papers, licenses; to organize the evaluation of the site for the construction of radiation establishment, the design of radiation establishment, the design of radiation safety means and other cases specified by law;
e/ To organize the system of statistics and filing records on radiation establishments, radioactive sources, radiation apparatus, personal doses;
f/ To organize and direct the elaboration of plans for preventing and combating radiation incidents, and overcoming consequences thereof;
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h/ To organize the training of personnel working in the field of radiation safety and control;
i/ To organize the education, propagation and popularization of knowledges about radiation safety and control;
j/ To build and develop the material and technical foundations for radiation safety and control activities; to organize the environmental radiation monitoring, personal dosemetry services, control and calibration of dosemeters, measurement of activity of radioactive sources...
k/ To guide and inspect ministries, branches, localities, organizations and individuals in the implementation of the Ordinance on Radiation Safety and Control; to perform and organize the specialized inspection on radiation safety and control;
l/ To submit to the Government proposals on Vietnam's participation in international organiza-tions; signing of or acceding to international agreements on radiation safety, nuclear safety; to carry out international activities related to radiation safety and/or nuclear safety;
m/ To resolve complaints and/or denunciations; to deal with violations of legislation radiation safety and control according to law.
2. The State management agency in charge of radiation safety and control under the Ministry of Science, Technology and Environment shall act as the body assisting the Minister of Science, Technology and Environment in the exercise of State management function over radiation safety and control in the whole country.
1. To elaborate radiation safety standards for radioactive pharmaceuticals, foods, foodstuffs, drinking water and guidances for safety in diagnosis and treatment by radiation;
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3. To organize specialized health stations for medical examination and health care for radiation personnel; to give first-aid and treatment to overdose-exposed persons or patient of radiation diseases; to organize periodical examination for detection of occupational diseases by radiation;
4. To issue the list of diseases and/or handicaps banned from working with radiation.
1. The inspection of the observance of law provisions on the transportation of radioactive substances, radioactive waste and radioactive sources.
2. The investigations of the losses of radioactive sources, the illegal trading, trafficking and use of radioactive sources.
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2. The Customs offices shall inspect and supervise the transportation of radioactive sources at border gates.
3. The Ministry of Science, Technology and Environment shall issue technical regulations in order to ensure safe transport of radioactive substances (including radioactive sources and waste).
a/ To promulgate, according to their respective competence, legal documents on radiation safety and control within the branch in accordance with the Ordinance on Radiation Safety and Control and this Decree.
b/ To direct and inspect the observance of law provisions, plans and measures on radiation safety and control within the branch.
2. The Ministry of Public Security and the Ministry of National Defense shall have to ensure radiation safety for their radiation establishments, radiation-related activities under their management, which require confidentiality.
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The duties, powers and organization of the provincial/municipal Department of Science, Technology and Environment in the field of radiation safety and control shall be specified by the People's Committees of the provinces and cities directly under the Central Government under the guidance of the Ministry of Science, Technology and Environment.
INSPECTION AND DEALING WITH VIOLATIONS
The Ministry of Science, Technology and Environment shall be responsible to the Government for the organization and guidance of the performance of specialized radiation safety and control inspection function according to the following tasks:
1. To control and inspect the implementation of the Ordinance on Radiation Safety and Control throughout the country.
2. To control and inspect the observance of law provisions on radiation safety and control by radiation establishments.
3. To coordinate with inspectors of other ministries, the State labor inspectors, environment inspectors in performing the task of control and inspection of labor safety, labor hygiene and environmental protection in performing radiation work.
4. To investigate radiation incidents and coordinate with labor safety inspectors of the Labor, War Invalids and Social Affairs Services in investigating case of labor accidents related to radiation, causing serious overexposure or death to radiation worker(s).
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2. Irregular radiation safety inspections shall be carried out when solving complaints and/or denunciations; when the Ministry of Science, Technology and Environment discovers signs of violation against the Ordinance on Radiation Safety and Control; or at the request of the Government, State Inspectorate.
For violations of stipulations in licenses or violations which are causing or will cause radiation incidents, the competent bodies or inspectors shall have to immediately issue decisions to temporarily suspend part or the whole of the work in order to avoid serious consequences.
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FOR THE GOVERNMENT
PRIME MINISTER
Phan Van Khai
- 1 Circular No. 05/2006/TT-BKHCN of January 11, 2006, guides on declaration and authorization issuance of radiation-related practice
- 2 Circular No. 14/2003/TT-BKHCN of July 11th, 2003, guiding on radiation transportation safety.
- 3 Joint circular No. 2237/1999/TTLT-BKHCNMT-BYT of December 28, 1999 guiding the implementation of medical radiation safety