L A W ON RADIATION PROTECTION OF THE REPUBLIC OF LITHUANIA

Transcription

1 Translation from Lithuanian Law published in the official gazette Valstybės žinios, 1999, No The wording of the Law comes into force on The wording of sub-paragraph 2 of paragraph 3 of Article 8 of the Law comes into force on L A W ON RADIATION PROTECTION OF THE REPUBLIC OF LITHUANIA 12 January 1999, No VIII-1019 Vilnius CHAPTER ONE PURPOSE AND MAIN DEFINITIONS OF THE LAW Article 1. Purpose of the Law This Law shall regulate relations of legal entities and natural persons, other organisations, affiliates of legal entities and other organisations arising from practices involving sources of ionising radiation and radioactive waste management. This Law shall establish the legal framework for radiation protection aimed at protecting people and the environment from the harmful effects of ionising radiation. Article 2. Main Definitions 1. Exposure: the process during which a human being or the environment is exposed to ionising radiation. 2. Practices in the area of nuclear energy involving sources of ionising radiation: practices involving sources of ionising radiation carried out in nuclear installations as well as other operations involving nuclear fuel cycle materials and nuclear materials the amount of which goes beyond the amount indicated in Annex 1 to the Law on Nuclear Safety of the Republic of Lithuania. 3. Worker whose work involves sources of ionising radiation (the worker): a civil servant, an employee working under an employment contract or other basis, whose activities involve sources of ionising radiation or who is affected by them and is exposed to a dose of ionising radiation which may exceed the limits established with respect to the members of the public. 4. Natural ionising radiation (the natural radiation): ionising radiation which consists of cosmic radiation and radiation of naturally occurring radionuclides. 5. Members of the public: all natural persons, other than workers, apprentices and students who use sources of ionising radiation during their training, and other than those natural persons exposed to radiation for their own health care, and those voluntarily helping patients or participating in scientific medical and biomedical research. 6. Ionising radiation: radiation capable of producing ions with different charges in the biological environment. 7. Ionising radiation generator: a device or a part of device capable of generating ionising radiation but containing no radioactive substances. Ionising radiation generator is a source of ionising radiation. 8. Source of ionising radiation: a device, a radioactive material, a facility, a product or a commodity producing or capable of producing ionising radiation. 9. Temporary permit: a document authorising the persons covered under paragraph 2 of Article 8 of this Law possessing a document issued in a Member State, which allows to engage in the practices involving sources of ionising radiation, to temporarily engage in the Republic of Lithuania in the practices allowed by the temporary permit and adhering to the conditions and requirements established by this Law, other laws and legal acts. The institution issuing temporary permits shall assess the temporary nature of 1

2 engagement in the relevant practices and shall establish the term of validity of the temporary permit in consideration of the length, regularity, frequency, and continuation of the practices. 10. Permit to ship radioactive materials: a document authorising to import to and export from the Republic of Lithuania, to ship in transit or to ship within the Republic of Lithuania the radioactive materials adhering to the conditions and requirements established in this Law and other legal acts. 11. Holder of a permit to ship radioactive materials: a person holding a permit issued in accordance with the legal acts, which authorises to import to, export from, the Republic of Lithuania, as well as to ship in transit or to ship within the country the radioactive materials, and who is responsible for compliance with the conditions of practice regulated by permit. 12. Medical exposure: exposure encountered by patients as part of their own health care, during scientific medical and biomedical research and by persons, other than workers, while voluntarily helping patients. 13. Non-medical exposure: exposure not attributable to medical exposure and incurred while seeking to obtain information for the purposes other than disease diagnostics and/or improvement of treatment and health condition. 14. Exemption levels for practices involving sources of ionising radiation (the exemption levels): criteria, based on which, certain practices are exempt from the radiation protection regulation and do not require a licence or a temporary permit. 15. Orphan source of ionising radiation: a sealed source of ionising radiation, the activity level of which, at the time of its discovery, is above the exemption level established by the legal acts, and which is not, however, under regulatory control either because it has never been under regulatory control or because it has been abandoned, lost, misplaced, stolen or transferred to a new holder of a licence or a temporary permit without proper notification of the competent authority and without informing the recipient of the source of ionising radiation. 16. Radiation protection: an aggregate of legal, organisational, and technical measures aimed at ensuring protection of people and the environment against the harmful effect of ionising radiation. 17. Radioactive material: material containing one or more radionuclides with the activity or specific activity above the limit established by legal acts. 18. Radioactive contamination: contamination of any material, its surface or the environment and a human being (both external contamination of the skin and internal contamination) with radioactive materials. 19. Radiological accident: extraordinary event resulting from equipment failure, operating errors or other reasons, the consequences or potential consequences of which require immediate actions in order to minimise the risk of harmful effect of ionising radiation on people, their property or the environment. 20. Radiological incident: extraordinary event resulting from equipment failure, operating errors or other reasons, or maliciously induced event or event arising out of illegal activity, falling short, however, of the criteria ascribed to the radiological accident. 21. A Member State: a Member State of the European Union, a state of the European Economic Area. 22. State radiation protection expert examination: an analysis of radiation protection data and its projected development carried out by state institutions authorised under this Law, other laws of the Republic of Lithuania and resolutions of the Government. 23. Practices involving sources of ionising radiation (the practices): activities involving sources of ionising radiation or radioactive waste, which cause or may cause additional radiation exposure of workers and members of the public, or which increase the number of individuals exposed, or the likelihood of such exposure. 24. Other definitions used herein shall carry the meanings prescribed to them in the Law on Nuclear Energy of the Republic of Lithuania, the Law on Nuclear Energy of the Republic of Lithuania, and the Law on the Management of Radioactive Waste of the Republic of Lithuania. Article 3. Main Principles of Radiation Protection All practices shall be authorised and conducted in accordance with the following basic principles of radiation protection: 1) the principle of justification of the operation of sources of ionising radiation - the economic, social and other benefits yielded by all types of practices involving operation of sources of ionising radiation to individuals or society must outweigh the detriment radiation causes to human health and the environment; 2) the principle of optimisation - any kind of exposure of individuals and society must be as low as reasonably achievable, taking into account the economic and social factors; 2

3 3) the principle of limitation - the sum total of doses resulting from all types of practices shall not exceed the fixed value, with the exception of a individual dose received by a patient for his own health care and an individual (other than as part of his occupation) voluntarily helping a patient or participating in scientific medical and biomedical research. CHAPTER TWO STATE MANAGEMENT OF RADIATION PROTECTION Article 4. Competence of the Government of the Republic of Lithuania in the Area of State Management of Radiation Protection The Government of the Republic of Lithuania (the Government) shall: 1) establish living and economic conditions under an emergency regime in the territories affected by a nuclear or radiological accident; 2) establish the State Register of Sources of Ionising Radiation and Exposure of Workers and approves the regulations thereof; 3) establish the procedure for management of radiological incidents and accidents and elimination of the consequences thereof; 4) perform other functions prescribed under this Law, other laws and legal acts. Article 5. Competence of the Head of a Municipal Administration in the Area of Radiation Protection Radiation protection shall be a function delegated by the state to municipalities, where the head of a municipal administration shall be responsible for the exercise of such function. The head of a municipal administration shall: 1) in accordance with the laws and other legal acts of the Republic of Lithuania, provide information to the public about nuclear and radiological accidents, contamination with radioactive materials, which may affect or which have affected the environment, human health or life, and the undertaken radiation protection measures; 2) develop plans for radiation protection of people, as well as for elimination of consequences of nuclear and radiological accidents, and implement such plans in the event of a nuclear or radiological accident; 3) perform other functions related to radiation protection as prescribed under other laws and legal acts. Article 6. Competence of the Ministry of Health of the Republic of Lithuania in the Area of State Management of Radiation Protection 1. The Ministry of Health of the Republic of Lithuania (the Ministry of Health), with the purpose of implementation of the provisions of the European Union and international legal acts, shall prepare draft laws and Government resolutions regulating radiation protection of members of the public, workers and the environment from the harmful effect of sources of ionising radiation. 2. The Ministry of Health shall draft and approve the legal acts establishing: 1) the dose limits of exposure permissible for population and certain groups of population, as well as the requirements for compliance therewith; 2) the levels of doses of exposure and contamination applicable in the event of a nuclear and/or radiological accident; 3) the radiation protection requirements for population, certain groups of population, and the environment; 4) the exemption levels; 5) the recommended levels of medical exposure applicable in the course of the medical diagnostics and treatment procedures involving the use of ionising radiation; 6) the list of non-medical exposure procedures and the order of their performance; 7) the limits of emission of radionuclides into the environment from medical, industrial (excluding nuclear installations), agricultural objects and in the course of scientific research, and the procedure for issuing permits for the emission of radionuclides into the environment; 8) together with the State Nuclear Power Safety Inspectorate the procedure for import to, export from, shipment in transit or transportation within the Republic of Lithuania of radioactive materials, radioactive waste and spent nuclear fuel, and the rules for issuance of the relevant permits. 3

4 3. Within the limits of its competence, the Ministry of Health shall coordinate and organise: 1) control of compliance with the standards allowed for emission of radionuclides into the environment from medical, industrial (excluding nuclear installations), agricultural objects and in the course of scientific research; 2) monitoring of the effects on human health of the exposure (natural, medical, occupational and emergency) of members of the public and workers, and shall ensure management of the State Public Health Monitoring Data Fund; 3) in accordance with the licensing terms and conditions approved by the Government issuance, review, suspension, lifting of suspension and cancellation of licences and permits authorising engagement in practices involving ionising radiation as defined in paragraph 1 of Article 8 below; 4) supervision of compliance with the requirements for the practices involving ionising radiation established by this Law and other legal acts regulating radiation protection, except for the practices in the area of nuclear energy involving sources of ionising radiation, and supervision of application of statutory liability for violations of the said requirements; 5) preventative measures by warning about the discovery of orphan sources of ionising radiation and objects contaminated with radionuclides, and the control over rehabilitation thereof; 6) preparedness of the national health system institutions to eliminate the consequences of nuclear and radiological accidents; 7) public health education with respect to protection of health against the harmful effects of ionising radiation. 4. The Ministry of Health shall perform other functions appointed by this Law, other laws and legal acts. Article 7. Radiation Protection Centre and its Competence in the Area of State Management of Radiation Protection 1. The Radiation Protection Centre shall be an institution under the Ministry of Health. The Radiation Protection Centre shall be a public legal entity, a budgetary institution maintained from the state budget and other state monetary funds, having bank accounts, and a seal bearing the State Emblem and the name of the institution. The purpose of the Radiation Protection Centre shall be to coordinate actions of state and municipal institutions in the manner established by the Government or, upon direction from the Government, by the Minister of Health, in the area of radiation protection, to exercise the state regulation and supervision of both radiation protection in respect of exposure of members of the public and the environment and the practices involving sources of ionising radiation, except for coordination of the actions of state and municipal institutions in the field of radiation protection when engaged in the practices in the area of nuclear energy involving sources of ionising radiation and for state regulation and supervision of the practices in the area of nuclear energy involving sources of ionising radiation. 2. The Radiation Protection Centre shall operate in accordance with its regulations approved by the Government and in accordance with the annual plan of the Radiation Protection Centre approved by the Minister of Health. The Government may delegate the function of approval of the regulations of the Radiation Protection Centre to the Minister of Health. 3. The Minister of Health shall appoint and dismiss the director of the Radiation Protection Centre for a four-year term of office in the manner established by the Law on Public Service of the Republic of Lithuania. The director of the Radiation Protection Centre shall be directly subordinate and accountable to the Minister of Health. 4. Decisions on behalf of the Radiation Protection Centre shall be adopted by the director of the Radiation Protection Centre. The decisions on other statutory issues falling within the competence of the Radiation Protection Centre shall be adopted in the manner prescribed by the regulations of the Radiation Protection Centre by the director of the Radiation Protection Centre and other officials of the Radiation Protection Centre, civil servants, and workers engaged under employment contracts. 5. The Radiation Protection Centre: 1) in accordance with the procedure established by laws, shall participate in developing and implementing state policy in the area of radiation protection, and shall prepare the draft legal acts related to radiation protection issues; 2) shall participate, within its competence, in determining the principles and criteria for state regulation of accounting of the radiation protection and the sources of ionising radiation, and for ensuring radiation protection and physical protection of the sources of ionising radiation, and shall also prepare and 4

5 approve the description of the procedure and recommendations for implementing the said principles and criteria; 3) in the manner established by the licensing rules approved by the Government, shall issue licences or temporary permits to engage in the practices involving sources of ionising radiation as defined in paragraph 1 of Article 8 hereof; and shall review, suspend, lift the suspension or cancel such licences or temporary permits; 4) shall monitor compliance with the requirements set out in this Law and other legal acts regulating radiation protection and physical protection of sources of ionising radiation, with the exception of the requirements applicable in case of the practices in the area of nuclear energy involving sources of ionising radiation, and shall impose statutory liability for violations of such requirements; 5) shall organise and exercise state regulation and supervision of the persons who are not subject to licences or temporary permits that are issued by the Radiation Protection Centre, but whose operations, however, may result in exposure of population or the environment, and/or engagement in such operations creates likelihood of discovery of an orphan source of ionising radiation or an object contaminated with radionuclides; 6) shall organise and conduct monitoring of contamination with radionuclides of air, drinking water, foodstuffs and food produce, construction materials and the products thereof, as well as other objects which may create exposure to population; shall take and obtain necessary samples in accordance with the procedures established by laws and other legal acts; 7) shall conduct monitoring of the effects on human health of exposure (natural, medical, occupational, and emergency) of members of the public and workers; shall supply data to the State Public Health Monitoring Data Fund according to the procedure established by the Ministry of Health; 8) shall control compliance with the standards of emission of radionuclides into the environment from medical, industrial (excluding nuclear installations), agricultural objects and when conducting scientific researches, and shall issue permits authorising to emit radionuclides into the environment; 9) shall control implementation of the preventative measures that are used for warning about occurrence of the orphan sources of ionising radiation and the objects contaminated with radionuclides, and shall monitor handling of the objects contaminated with radionuclides; 10) shall draft surveys on the condition of radiation protection and render proposals to state and municipal institutions on the radiation protection related issues, as well as provide information to the public; 11) shall organise and conduct monitoring of the individual exposure of members of the public, workers or certain risk groups under normal conditions, in the events of nuclear and radiological accidents and incidents, and shall also carry out research and assessment of the effects of ionising radiation on human beings; 12) shall conduct research and state expert examination, within its competence, on the condition of radiation protection; 13) in the manner established by the Government, shall organise management of radiological incidents and accidents, participate in elimination of their consequences, and, within its competence, shall take part in the management of nuclear accidents and in elimination of their consequences; 14) shall plan and organise, at the state level, implementation of preventative measures against radiological incidents and accidents; 15) shall participate, within its competence, in the process of territorial planning and construction of buildings; 16) shall cooperate, within its competence, with international and local organisations in the area of radiation protection, and shall participate in the activities of international organisations, the EU institutions, committees, and groups; 17) shall manage the State Register of Sources of Ionising Radiation and Exposure of Workers; in the manner established by legal acts, shall provide access for the State Nuclear Power Safety Inspectorate to the register data that are requisite for proper performance of its functions; 18) shall initiate and coordinate the radiation protection-related scientific research and testing required for improvement of radiation protection; 19) at the request of interested persons, shall provide paid public health care services according to the list and rates approved by the Ministry of Health; 20) at the request of the holders of licences or temporary permits, shall refer to the Police Department under the Ministry of the Interior of the Republic of Lithuania, the State Security Department of the Republic of Lithuania, healthcare institutions, and the Central Mortgage Office in order to verify whether there are any circumstances mentioned in paragraph 17 of Article 10 below, which could prevent a particular 5

6 natural person from being entrusted with the physical protection of the sealed sources of ionising radiation with danger categories I, II, III or from being accepted to work involving shipment of the sealed sources of ionising radiation with danger categories I, II, III. After the above specified institutions provide, within the limits of their competence, their written answers not later than within 20 calendar days after the receipt of the request, the Radiation Protection Centre shall produce an opinion to the holder of the licence or temporary permit concerning the eligibility of such person for such work; 21) shall perform other functions appointed by this Law, other laws and legal acts. Article 7 1. Competence of the State Nuclear Power Safety Inspectorate in the Area of State Management of Radiation Protection The State Nuclear Power Safety Inspectorate, in exercising state regulation of and supervision over the radiation protection of those engaged in the practices in the area of nuclear energy involving sources of ionising radiation, shall: 1) following the procedure and conditions established by the licensing rules approved by the Government, issue licences or temporary permits to engage in the practices in the area of nuclear energy involving sources of ionising radiation as defined in paragraph 1 of Article 8 below, as well as review, suspend, lift the suspension or cancel their validity; 2) after coordination with the Ministry of Health, draft and approve the radiation protection requirements of workers or certain risk groups of workers, who permanently or temporarily work in nuclear installations, as well as of other persons who temporarily perform operations in nuclear installations; 3) monitor the compliance with the radiation protection requirements established in this Law and in other legal acts regulating radiation protection in performing the practices in the area of nuclear energy involving sources of ionising radiation, and shall impose statutory liability for failure to observe the same; 4) monitor the compliance with the radiation protection requirements by workers, or certain risk groups of workers, who permanently or temporarily work in nuclear installations and by other persons who temporary perform operations in nuclear installations; 5) organise and, in the area of its competence, conduct the research and state expert examination of radiation protection condition when practicing in the area of nuclear energy involving sources of ionising radiation; 6) provide information to the state and municipal institutions, agencies, and organisations about the radiation protection condition when practicing in the area of nuclear energy involving sources of ionising radiation; 7) participate in conducting investigations of nuclear and radiological accidents in nuclear installations, forecast their consequences and render proposals on how they can be avoided or eliminated; 8) within its competence, cooperate with international and local organisations in the area of radiation protection and participate in the activities of international organisations and the EU institutions, committees, and groups; 9) perform other functions appointed by this Law, other laws and legal acts. CHAPTER THREE LICENSING CONDITIONS OF PRACTICES IN THE AREA OF RADIATION PROTECTION Article 8. Licensing of Practices, Issuance of Temporary Permits and Permits to Ship Radioactive Materials and Radioactive Waste Generated in the Course of Non-Nuclear Fuel Cycle 1. It shall be prohibited to produce, operate, store, assemble, maintain, repair, recycle sources of ionising radiation, market them, ship radioactive materials, handle (carry out pre-treatment of radioactive waste (collect, sort, decontaminate), carry out treatment of radioactive waste, store) and ship radioactive waste and, without possession of sources of ionising radiation, engage in practices under ionising radiation at a nuclear installation or to engage in practices under ionising radiation at the facility of another person indicated in paragraph 2 below, without the licence or temporary permit issued in the manner established by the licensing rules approved by the Government, with the exception of cases listed in paragraph 3 of this Article. 2. A national of the Republic of Lithuania or a citizen of other Member State, other natural person exercising the right of free movement in the Member States under the laws of the European Union, a legal entity established in the Republic of Lithuania or a legal entity established in other Member State, other organisation or affiliates thereof, as well as the affiliates of a foreign legal entity or other organisation 6

7 established in the Republic of Lithuania (the person) may be authorised to the practices specified in paragraph 1 above. 3. The licence or temporary permit specified in paragraph 1 of this Article shall not be required: 1) for the practices involving sources of ionising radiation within the exemption levels; 2) for shipment and storage of ionising radiation generators; 3) for shipment of radioactive materials in uncontrolled packages, specified in international agreements regulating carriage of dangerous goods to which the Republic of Lithuania is a party. 4. The types of licences or temporary permits: 1) licence or temporary permit to manufacture, operate, store, maintain, repair, recycle sources of ionising radiation and/or handle (carry out pre-treatment of radioactive waste (collect, sort, decontaminate), carry out treatment of radioactive waste, store) radioactive waste; 2) licence or temporary permit to assemble sources of ionising radiation; 3) licence or temporary permit to market sources of ionising radiation; 4) licence or temporary permit to ship radioactive materials and/or radioactive waste; 5) licence or temporary permit to engage in the practice under ionising radiation at a nuclear installation; 6) licence or temporary permit to engage in the practice under ionising radiation at the facility of another person holding the licence. 5. Licences or temporary permits to engage in the practices mentioned in paragraph 1 of this Article, except for the practices in the area of nuclear energy involving sources of ionising radiation, shall be issued by the Radiation Protection Centre. 6. Licences or temporary permits to engage in the practices in the area of nuclear energy involving sources of ionising radiation, as referred to in paragraph 1 of this Article, shall be issued by the State Nuclear Power Safety Inspectorate. 7. Import to, export from, shipment in transit or transportation within the Republic of Lithuania of radioactive materials shall be subject to the permit issued by the Radiation Protection Centre or the State Nuclear Power Safety Inspectorate in the manner established by legal acts. Natural persons, legal entities, other organisations, affiliates of legal entities or other organisations wishing to obtain a permit for shipment of radioactive materials shall provide, in accordance with the law, the Radiation Protection Centre or the State Nuclear Power Safety Inspectorate with an application of official form. Non provision of a reply concerning the permit authorising shipment of radioactive materials shall not be considered as authorisation to ship radioactive materials. If natural persons, legal entities, other organisations, affiliates of legal entities or other organisations that are authorised to ship radioactive materials fail to act in accordance with the legal acts regulating radiation protection and do not remedy the specified infringements within the time-limit allowed by the authorising institution, the Radiation Protection Centre or the State Nuclear Power Safety Inspectorate shall cancel, in the manner established by laws, the permit authorising to ship radioactive materials. 8. Import to, export from, shipment in transit or transportation within the Republic of Lithuania of radioactive waste generated during a non-nuclear fuel cycle shall be allowed only subject to the permit issued by the Radiation Protection Centre in the manner established by legal acts. Natural persons, legal entities, other organisations, affiliates of legal entities or other organisations wishing to obtain a permit for shipment of radioactive waste generated during a non-nuclear fuel cycle shall provide, in accordance with the law, the Radiation Protection Centre with an application of official form. Non provision of a reply concerning the permit for shipment of radioactive waste generated during a non-nuclear fuel cycle shall not be considered as authorisation to ship radioactive waste generated during a non-nuclear fuel cycle. If natural persons, legal entities, other organisations, affiliates of legal entities or other organisations that are authorised to ship radioactive waste generated during a non-nuclear fuel cycle fail to act in accordance with the legal acts regulating radiation protection and do not remedy the specified infringements within the time-limit allowed by the Radiation Protection Centre, the latter shall cancel, in the manner established by laws, the permit authorising to ship radioactive waste generated during a non-nuclear fuel cycle. 9. If a person holds a licence or a temporary permit issued by the Radiation Protection Centre for the practices referred to in paragraph 1 of this Article above, an additional licence or temporary permit for temporary practices involving the same sources of ionising radiation at a nuclear installation or for temporary practices under ionising radiation at a nuclear installation shall not be issued; but, the Radiation Protection Centre may issue or revise such licence or temporary permit only upon coordination by the State Nuclear Power Safety Inspectorate, within its competence, of the documents required under the licensing rules approved by the Government. 7

8 10. The issuance of a licence or a temporary permit, their revision, the issuance of a duplicate of a licence or a temporary permit in cases covered under paragraph 1 of this Article above, as well as the issuance of a permit to ship radioactive materials and radioactive waste generated during a non-nuclear fuel cycle or its duplicate in cases indicated in paragraphs 7 and 8 of this Article, shall be subject to a stamp duty. 11. The procedure for import, transit, and export of radioactive materials attributable to strategic goods, shall be established by the Law Concerning Control of Strategic Goods. 12. It shall be prohibited to add radioactive materials to foodstuffs, toys, jewellery, cosmetics and to market, import and export such products. 13. Natural persons, legal entities, other organisation, affiliates of legal entities and other organisations acting in violation of the requirements established under paragraph 1 of this Article shall be liable according to the laws of the Republic of Lithuania. Article 8 1. Documents Required for Issuance of a Licence Persons wishing to obtain any licence or a temporary permit listed in paragraph 4 of Article 8 hereof, shall provide the institution issuing the same with an application of official form (the form of application shall be determined by the issuing institution) accompanied by the following documents: 1) a reasoned explanation of the future practices; 2) a workers radiation protection programme and the documents evidencing that engagement in the practices involving sources of ionising radiation will be safe in terms of radiation protection of human beings and the environment as required under the licensing rules approved by the Government; 3) comprehensive information about the sources of ionising radiation: copies of certificates and other technical documentation. Article 8 2. Documents Required for Issuance of a Temporary Permit Persons holding a document issued in a Member State that authorises engagement in practices involving sources of ionising radiation, and wishing to obtain a temporary permit shall provide the institution issuing temporary permits with the following documents: 1) an application for issuance of a temporary permit (the form of application shall be determined by the issuing institution); 2) a copy of a valid document authorising engagement in practices involving sources of ionising radiation issued in a Member State, and its translation into the Lithuanian language; 3) a workers radiation protection programme and the documents evidencing that engagement in the practices involving sources of ionising radiation in the Republic of Lithuania will be safe in terms of radiation protection of human beings and the environment as required under the licensing rules approved by the Government. Article 8 3. Examination of Documents Submitted for Issuance of a Licence or a Temporary Permit 1. The institution issuing licences or temporary permits shall, within 30 calendar days from receipt of all duly completed documents required for issuance of a licence or a temporary permit, adopt a decision to issue the licence or temporary permit or a reasoned decision to refuse issuance thereof and shall, not later than within 5 business days, inform in writing the person who submitted the application for the issuance of a licence or a temporary permit. 2. If a person has submitted an incomplete set of documents required for the issuance of a licence or a temporary permit and has failed within the time-limit established by the institution issuing licences or temporary permits to provide the missing documents, the institution issuing licences or temporary permits shall, not later than within 5 business days, notify in writing such person that the application for issuance of a licence or a temporary permit is left unexamined. 3. Issuance of a licence or a temporary permit shall be denied, if: 1) submitted documents do not meet the requirements; 2) it is established during the state supervision of radiation protection that the submitted data are misleading, inaccurate, incomplete. 4. Non provision of a reply regarding the issuance of a licence or a temporary permit shall not be qualified as issuance of the licence or the temporary permit. Article 8 4. Revision of Licence or Temporary Permit, Issuance of Duplicate, Suspension, Lifting of Suspension, and Cancellation 8

9 1. A licence or a temporary permit shall be revised upon change in at least one of the following data indicated in the licence or temporary permit: the name, legal form, registration code, registered address of a legal entity, other organisation or their affiliate; or the name, surname, personal identification code, residence address of a natural person. The licence or temporary permit holder shall report such changes in the data to the issuing institution not later than within 10 business days from the date of such change by filing an application for revision of the licence or temporary permit and enclosing the documents evidencing change in the data. 2. A person who lost the original of a licence or temporary permit, or in the event the original thereof is damaged, shall provide the issuing institution with a written request to issue a duplicate of such licence or temporary permit. 3. A licence or a temporary permit shall be suspended, if: 1) the practices are carried out in violation of the requirements for radiation protection or physical protection of sources of ionising radiation thereby posing threat to human health and life and causing detriment to the environment; 2) the holder of a licence or a temporary permit fails to duly and timely provide a comprehensive information to the institution issuing licences and temporary permits about the fact of radiological incident or accident and to take measures for elimination of effects and consequences hazardous to human health and the environment; 3) the holder of a licence or a temporary permit, who had been previously warned in the manner established by the licensing rules approved by the Government about the violations of the legal acts regulating radiation protection, fails to remedy the respective violations within the time-limit given by the institution issuing licences or temporary permits; 4) the holder of a licence or a temporary permit applies with a request to suspend the licence or temporary permit. 4. The suspension of a licence or a temporary permit shall be lifted if the holder thereof provides the institution issuing licences or temporary permits with: 1) a request to lift the suspension of the licence or temporary permit; 2) the documents and other information evidencing remedy of the violations and/or deficiencies under the legal acts regulating radiation protection that caused suspension of the licence or the temporary permit (except under circumstances described in sub-paragraph 4 of paragraph 3 of this Article). 5. A licence or a temporary permit shall be cancelled, if: 1) the holder of a licence or temporary permit decides to discontinue the practices and applies in writing to the institution issuing licences or temporary permits requesting to cancel the licence or temporary permit; 2) the holder of a licence or temporary permit fails to remedy, within the time-limits imposed by the issuing institution, the violations that caused suspension of the licence or temporary permit on the grounds defined in sub-paragraphs 1, 2 and 3 of paragraph 3 of this Article; 3) the legal entity, other organisation or affiliate thereof holding a licence or temporary permit ceased to exist by way of liquidation or reorganisation; or the natural person holding a licence or temporary permit died. Article 9. BECAME NULL AND VOID under: Law No XI-1540 as of 28 June 2011 (effective from 1 October 2011) (Official Gazette, 2011, No ) CHAPTER FOUR RADIATION PROTECTION REQUIREMENTS Article 10. Duties of Licence or Temporary Permit Holder Holder of a licence or a temporary permit shall: 1) ensure registration of the sources of ionising radiation, secure proper technical condition, physical protection and safe operation thereof and duly notify, in accordance with the procedure established by legal acts, the State Register of Sources of Ionising Radiation and Exposure of Workers about the sources in possession; 2) as far as possible minimise the exposure of workers; 9

10 3) ensure protection of the members of the public who visit, or workers of other enterprises, institutions or organisations who are temporarily working on the sites holding practices involving sources of ionising radiation in accordance with the requirements of this Law and other legal acts relating to radiation protection; 4) appoint qualified responsible persons or establish relevant departments to ensure compliance with and enforcement of the requirements of this Law and other legal acts regulating radiation protection; 5) ensure that workers meet the qualification requirements established by legal acts, technical standard documents and deeds governing internal procedure regulations of the holder of a licence or a temporary permit; 6) carry out monitoring of exposure of workers and workplaces in accordance with the procedure established by legal acts; 7) provide the State Register of Sources of Ionising Radiation and Exposure of Workers with data on workers in the manner established by legal acts; 8) by own initiative or at the request of the authorised state institutions, discontinue practices which do not comply with the requirements of the legal acts regulating radiation protection; 9) in the manner established by laws and other legal acts of the Republic of Lithuania, transfer for conditioning the improper or disused sources of ionising radiation; 10) in the manner established by laws and other legal acts of the Republic of Lithuania, carry out monitoring of the environment of the licence or temporary permit holder; 11) not exceed the limits permitted by legal acts for emission of radionuclides into the environment, and take every reasonable step to lower such emission to the minimum extent; 12) provide the institution issuing licences or temporary permits (upon request of the institution) with objective information about the conditions of operation, manufacturing, import, marketing, export from the Republic of Lithuania of the products containing sources of ionising radiation; 13) take preventive measures against radiological incidents or accidents, in the manner established by the Government or its authorised institution to timely inform in detail the population and the state and municipal institutions of the Republic of Lithuania about the risks associated with the practices involving sources of ionising radiation; in the event of a radiological incident or accident, take actions and measures for elimination of causes and consequences hazardous to human health and the environment; in accordance with this and other laws, compensate the damage to human health and the environment resulting from violation of the legal acts regulating radiation protection; 14) mark the sources of ionising radiation and containers thereof, and provide consumers with the information about protection from ionising radiation in accordance with the procedure established by legal acts; 15) where, in accordance with the procedure established by this Law and other legal acts, a person has a right to market or transfer for use sources of ionising radiation, such person must ascertain that persons to whom those sources of ionising radiation are being sold or transferred, are in possession of a license or a temporary permit to use them; 16) before appointing a particular natural person in charge of physical protection of the sealed sources of ionising radiation under danger categories I, II, III, or before employing such person for shipment of the sealed sources of ionising radiation under danger categories I, II, III, apply to the Radiation Protection Centre requesting to arrange screening of such person to determine his/her eligibility for such work; 17) not appoint a particular person in charge of physical protection of the sealed sources of ionising radiation under danger categories I, II, III and not employ such person for shipment of the sealed sources of ionising radiation under danger categories I, II, III, if such person is under 18 years of age, or having previous conviction for serious and grave crimes or crimes against property, property rights and property interests, public security relating to possession of weapons, ammunition, explosives, explosive or radioactive materials or military equipment, or who is subject to preventative sanctions according to the Law on Organised Crime Prevention of the Republic of Lithuania, or there are other circumstances based on which the Police Department under the Ministry of the Interior of the Republic of Lithuania or the State Security Department of the Republic of Lithuania would consider such person as ineligible for such work, or such person suffers from diseases making him/her ineligible for such work, is on a record of a health care institution in connection with addiction to alcohol, drugs or is under supervision because of a mental illness or disorder, or has been entered in the register of legally incapable persons or persons of limited capability; 18) conduct the assessment of radiation protection of the practices in accordance with legal acts; 19) if the holder of a licence or a temporary permit does not refer in the manner prescribed herein regarding the lifting of suspension of the licence or temporary permit or the licence or temporary permit is 10

11 cancelled, such person must promptly transfer sources of ionising radiation held under the right of ownership (except for ionising radiation generators) to the radioactive waste manager for temporary storage in the manner and under the terms and conditions established by the Law on the Management of Radioactive Waste of the Republic of Lithuania, and notify the Radiation Protection Centre to that effect. Upon transfer of sources of ionising radiation held by a person under the right of ownership (except for ionising radiation generators) to the radioactive waste manager for storage, the owner of such sources shall retain the right to transfer, in accordance with the Civil Code of the Republic of Lithuania, such sources into the ownership of persons holding statutory licence or temporary permit; 20) perform other functions established by this Law, other laws and legal acts. Article Provision of Data to the State Register of Sources of Ionising Radiation and Exposure of Workers 1. Data on sources of ionising radiation and workers, except for data on workers employed with the persons listed in sub-paragraph 3 of this paragraph, must be provided to the State Register of Sources of Ionising Radiation and Exposure of Workers in accordance with legal acts by the following persons: 1) licence holders; 2) temporary permit holders; 3) persons engaged in the practices involving sources of ionising radiation that are not subject to a licence or a temporary permit referred to in paragraph 3 of Article 8 above. 2. The data on sources of ionising radiation and workers indicated in regulations of the State Register of Sources of Ionising Radiation and Exposure of Workers approved by the Government shall be provided to the State Register of Sources of Ionising Radiation and Exposure of Workers in the manner required by the Ministry of Health. Article 11. Radiation Protection Compliance Control 1. Sources of ionising radiation, radiation protection equipment, other devices and materials that may cause additional human exposure, as well as products containing sources of ionising radiation, shall be marketed or used only after having established their compliance with the radiation protection requirements. 2. The compliance with the requirements for radiation protection of sources of ionising radiation, radiation protection equipment, other devices and materials that may cause additional human exposure, as well as products containing sources of ionising radiation, except when engaged in practices in the area of nuclear energy involving sources of ionising radiation, shall be controlled by the Radiation Protection Centre in the manner established by the Ministry of Health, and in case where such sources of ionising radiation, radiation protection equipment, other devices, materials and products containing sources of ionising radiation may cause additional impact on the environment by the Radiation Protection Centre together with the Environmental Protection Agency. 3. The compliance with the requirements for radiation protection of sources of ionising radiation, radiation protection equipment, other devices and materials that may cause exposure, as well as products containing sources of ionising radiation when engaged in practices in the area of nuclear energy involving sources of ionising radiation shall be controlled by the State Nuclear Power Safety Inspectorate in the manner established by legal acts, and in cases where such sources of ionising radiation, radiation protection equipment, devices, materials and products containing sources of ionising radiation may cause additional impact on the environment by the State Nuclear Power Safety Inspectorate together with the Environmental Protection Agency. Article 12. Duties of Workers Workers must use adequate equipment of radiation protection and physical protection, undertake all measures to protect themselves and other persons or the environment from the harmful effects of ionising radiation. Article 13. Restrictions upon Engagement in Work Involving Sources of Ionising Radiation by Adolescents, Pregnant and Breast-Feeding Women 1. Work involving sources of ionising radiation may be performed by people who are over 18 years of age. 2. Persons in the age group of 16 to 18 may perform work with sources of ionising radiation only for the purposes of professional training and not exceeding the limits of exposure established by the Ministry of Health. 11

12 3. As established by the Labour Code, the employer must provide pregnant female worker with such work so as to ensure that the exposure of the foetus is not above the exposure levels as required for the members of the public in accordance with the procedure established by the Ministry of Health. 4. As established by the Labour Code, the employer must provide breastfeeding female worker with such work so as to avoid the risk of radioactive contamination of the system. Article 14. Surveillance of Workers Health 1. Workers are subject to a pre-employment medical examination and periodic health checks. Persons may be employed for work involving ionising radiation only subject to a health check undergone in accordance with the procedure determined by the Ministry of Health and conclusion by a medical commission confirming their health condition being fit for such kind of work. 2. When a worker has been identified with the symptoms of a disease related to the effects of ionising radiation or it has been established or there are grounds to suspect that the dose limits have been exceeded, before the causes and circumstances of the disease or increased exposure are established and the Radiation Protection Centre gives a permission for the worker to continue his/her work, the employer must provide the worker with alternative work different from a practice in accordance with the procedure established in the Labour Code. 3. It shall be forbidden to be engaged in the work with sources of ionising radiation for those persons who cannot be engaged in such work for health reasons. Article 15. Compulsory Training in Radiation Protection 1.The following persons in the Republic of Lithuania must undergo trainings in radiation protection: 1) workers of legal entities, other organisations, affiliates thereof, working with sources of ionising radiation; 2) servants of state and municipal institutions and organisations and workers employed under employment contract involved in operations with emergency management; 3) workers employed under employment contract, officials, managers of enterprises, institutions, organisations or their authorised persons, and other persons whose work (practices) is (are) related to finding of orphan sources of ionising radiation and objects contaminated with radionuclides. 2. Employers must organise at their own cost and expense training in radiation protection of the persons referred to in sub-paragraphs 1 and 3 of paragraph 1 of this Article in the manner established by the Ministry of Health, and training in radiation protection of the persons referred to in sub-paragraph 2 of paragraph 1 of this Article in the manner established by the Government. 3. Employers must provide workers with information relating to radiation protection prior to conclusion of the employment contract, when transferring them to another work involving sources of ionising radiation, when changing work (production) processes, technologies, working conditions involving sources of ionising radiation, as well as upon revision of standards, norms, regulations and instructions. 4. Employers are prohibited from appointing workers to be engaged in work involving sources of ionising radiation if they have not completed a compulsory training course or have not been provided with information about radiation protection. Article 16. Notification of Foreign Countries The extent of and procedure for notification of foreign countries about radiation protection in the Republic of Lithuania shall be established by international agreements and other legal acts. CHAPTER FIVE RADIOACTIVE WASTE AND DISUSED GENERATORS OF IONISING RADIATION Article 17. Radioactive Waste Radioactive waste shall be collected, sorted, treated, handled, reprocessed, shipped, stored, decontaminated, disposed or discharged into the environment pursuant to the laws and other legal acts of the Republic of Lithuania. Article 18. Decommissioning of Ionising Radiation Generators 1. The procedure for decommissioning of ionising radiation generators shall be established by the Ministry of Health or its authorised institution. 12