Below is a text of the Atomic Law Act consolidated by the Legal Department of the National Atomic Energy Agency.

Transcription

1 Below is a text of the Atomic Law Act consolidated by the Legal Department of the National Atomic Energy Agency. The wording of the Act which is enforceable since 1 January 2012 includes a uniform text of 14 February 2007 (Journal of Laws of 2007 No 42, Item 276) and subsequent amendments introduced by virtue of: 1) the Act of Parliament of 11 April 2008 on the Amendment of Act the Atomic Law (Journal of Laws of 2008 No 93, Item 583), 2) the Act of Parliament of 19 December 2008 on the Amendment of Act on Freedom of Economic Activities and Amendment of Other Laws (Journal of Laws of 2009 No 18, Item 97), 3) the Act of Parliament of 21 November 2008 on the Civil Service (Journal of Laws, No 227, Item 1505), 4) the Act of Parliament of 27 August 2009 on the Customs Service (Journal of Laws, No 168, Item 1323), 5) the Act of Parliament of 20 May 2010 on Medical Devices (Journal of Laws, No 107, Item 679), 6) the Act of Parliament of 15 April 2011 on Medical Activities (Journal of Laws, No 112, Item 654), 7) the Act of Parliament of 13 May 2011 amending the Act on Atomic Law and Other Laws (Journal of Laws, No 132, Item 766). ACT OF PARLIAMENT of 29 November 2000 Atomic Law i Chapter 1 General provisions Article 1.1. This Act shall determine the following: 1) activities related to peaceful uses of atomic energy, involving actual and potential exposures to ionizing radiation emitted by artificial radioactive sources, nuclear materials, ionizing radiation generating devices, radioactive waste and spent nuclear fuel; 2) duties of the head of organizational entity conducting these activities; 1

2 3) authorities competent in the matters of nuclear safety and radiological protection; 4) principles of liability for nuclear damage, 5) principles of the fulfilment of international obligations, including those within the European Union, involving nuclear safety, protection against ionizing radiation, nuclear material safeguards and the control of nuclear technologies. 2. This Act shall establish also financial penalties for the violation of nuclear safety and radiological protection regulations, and the rules for imposing such penalties. 3. This Act shall apply also to the activities conducted in conditions of exposure to natural ionizing radiation enhanced by human activity. 4. Moreover, this Act shall determine the principles of radioactive contamination monitoring and shall establish the rules governing the activities undertaken in the event of a radiation emergency as well as in chronic exposure conditions in the aftermath of radiation emergency or some past practice. 5. This Act shall define also special principles for the protection of people against the threats resulting from the ionizing radiation applications for medical purposes. Article 2. Activities referred to in Article 1 Section 1, Item 1 and Article 1 Section 3 shall be permitted after undertaking the measures defined in appropriate regulations, aimed at ensuring safety and protection of human life and health, as well as protection of the property and environment. Article 3. For the purposes of this Act, the terms used shall have the following meaning: 1) clinical audit systematic control or review of radiological medical procedures, aimed at the improvement of the quality of health services rendered to the patient through systematized analysis within which the radiological practice, procedures and results are compared to the recognized standards, and if necessary through the modification of existing procedure or the introduction of new standards; 1a) design basis accident emergency conditions of a nuclear facility accounted for in the nuclear facility design as per established design requirements, wherein fuel damage and radioactive substance release are maintained within specific limits; 2

3 2) nuclear safety achieving specific operating conditions, preventing and limiting the consequences of accidents, if any, to safeguard personnel and population protection against the risks of ionizing radiation from nuclear facilities; 2a) severe accident emergency conditions of a nuclear facility which are more serious than design basis accidents that lead to significant degradation of the reactor core and potential significant release of radioactive substances; 3) dose limit - value for ionizing radiation dose expressed in terms of effective dose or equivalent dose, established for specified individuals, coming from controlled occupational exposure, which shall not be exceeded, except under circumstances provided for in this Act; 4) absorbed dose absorbed dose as defined in Annex 1 to this Act; 5) equivalent dose equivalent dose as defined in Annex 1 to this Act; 6) effective dose effective dose as defined in Annex 1 to this Act; 7) intervention measures activities that prevent or mitigate human exposure resulting from radiation emergency consisting of actions aimed at the ionizing radiation source, radioactive contamination source, contamination pathways and at people; 7 1 ) safety function a function exercised by the system, a specific construction item or equipment item of a nuclear facility in order to provide safety; 7a) health care unit entity and individuals providing health services as defined in regulations on medical activities involving ionizing radiation; 8) organizational entity each and every entity engaged in activities involving exposure; 9) decommissioning of a nuclear facility bringing a nuclear facility or installation to the status which allows the conduct of any activity, with no limitations from the viewpoint of nuclear safety and radiological protection; 10) decommissioning of radioactive waste or spent nuclear fuel repository bringing the site of a radioactive waste repository or spent nuclear fuel repository to the status which allows the conduct of any activity with no limitations from the viewpoint of nuclear safety and radiological protection; 10a) operating limits and conditions a set of requirements stated in the licence for activities involving exposure and consisting in commissioning and operation of a nuclear facility, which defines threshold values of operating 3

4 parameters of a nuclear facility, the required functional availability, equipment performance and staffing; 11) nuclear material ores, starting (source) materials or special fissile materials, referred to in Article 197 of the Treaty establishing the European Atomic Energy Community, hereinafter referred to as Euratom Treaty ; 12) nuclear medicine all diagnostic activities involving the radiopharmaceuticals administered to the patients, and also therapeutic procedures involving radiopharmaceutical products; 13) medical radiological procedure description of activities necessary for performing an examination or treatment with the use of ionizing radiation, for diagnostic or therapeutic purposes; 14) medical radiological emergency unintended event, such as an error in radiological equipment operation, radiological equipment failure or interrupted operation, and also other unfortunate event, with consequences that may not be disregarded from the viewpoint of radiological protection of the patient; 15) exposure process in which human body is exposed to ionizing radiation; 16) emergency exposure exposure of the individual participating in the elimination of radiation emergency consequences or in the intervention measures, during which he / she may obtain a dose exceeding the annual dose limit for workers; 16a) normal operation operation of a nuclear facility within operating limits and conditions; 17) nuclear facility a nuclear power plant, research reactor, isotopic enrichment facilities, nuclear fuel production facilities, spent nuclear fuel reprocessing facilities, spent nuclear fuel storage facilities, as well as any radioactive waste storage facilities directly related thereto or located within the premises thereof; 18) target volume volume of the cancerous tumour or other tissues, which are irradiated to obtain a planned therapeutic effect; 19) physical protection all organizational and technical measures aimed at ensuring effective protection of nuclear materials and nuclear facilities against acts of terrorism, diversion, sabotage and theft; 20) radiological protection prevention of human exposure and environmental contamination, and if preventing such situations is not possible limitation of 4

5 their consequences to the lowest reasonably achievable level, taking into account economic, social and health factors; 21) radiological protection of the patient set of actions and restrictions aimed at the minimization of the patient s exposure to the ionizing radiation, which will not excessively hamper or prevent obtaining the desired and valid diagnostic information or therapeutic effects; 22) radioactive waste solid, liquid or gaseous materials containing radioactive substances or contaminated by such substances, further use of which is pointless or impossible, assigned to waste categories referred to in Article 47; this definition shall not be applicable to Chapter 8a; 23) dose constraint limiting value for anticipated individual doses, which may result from a specific ionizing radiation source, taken into account in radiological protection planning for optimization purposes; 24) radioactive waste management - all activities involving processing, handling, storage or disposal of radioactive waste, including the elimination of radioactive contamination and facility decommissioning; 25) spent nuclear fuel management all activities involving reprocessing, handling, storage or disposal of spent nuclear fuel, including facility decommissioning; 25a) established initiating emergency an emergency identified at the design stage of a nuclear facility which can lead to a predictable operating emergency or emergency conditions; 26) intervention level numerical value of avertable effective dose or equivalent dose, or the level of radioactive isotope content in foodstuffs and drinking water intended for people, and in feeds for animals, which necessitates the consideration of specific intervention measures if there is a possibility of exceeding this value; 27) reference levels ionizing radiation doses to the skin surface in medical X-ray diagnostic practices, or in case of administering radiopharmaceuticals to the patients levels of activity, related to the examination of standard-sized patients, for individual categories of radiological equipment. Reference levels shall not be exceeded for standard radiological procedures when using appropriate practices and technical equipment. Reference levels may be exceeded in case of important clinical indications; 28) external employer employer who employs the workers referred to in Article 17 Section 1, Item 1, conducting any activity on another employer s controlled area; 5

6 29) worker worker as defined in the provisions of the Labour Law, an individual performing work on the basis other than employment relationship, and also selfemployed individual, who in the ionizing radiation exposure conditions may obtain doses exceeding the dose limit values for the members of public; 30) external worker worker referred to in Article 17 Section 1, Item 1, employed by an external employer or self-employed, conducting any activity on a controlled area for which neither the worker, nor his /her employer is responsible; 31) apprentice individual undergoing a training or practice in the organizational entity, to acquire specific skills; 32) quality assurance program system of actions, which ensures the fulfilment of specified requirements for nuclear safety and radiological protection, depending on conducted activity, and in case of activities involving nuclear materials or nuclear facilities also the requirements for physical protection; 33) ionizing radiation radiation composed of directly or indirectly ionizing particles, or of both those types of particles, or electromagnetic radiation of wavelength of up to 100 nm (nanometres); 34) natural radiation ionizing radiation emitted from natural sources of terrestrial and cosmic origin; 35) spent nuclear fuel storage facility nuclear facility designed for safe, secure, stable and protected storage of spent nuclear fuel after its unloading from the nuclear reactor or from the reactor pool and before its transfer for reprocessing, or for disposal as radioactive waste; 36) storage of radioactive waste or spent nuclear fuel holding of radioactive waste or spent fuel with the intention of its retrieval for processing, reprocessing or disposal; 37) spent nuclear fuel reprocessing - process or operation aimed at partial or total extraction of radioactive isotopes from spent nuclear fuel for the purpose of their further usage; 38) nuclear material processing process or operation aimed at changing the nuclear material s physical or chemical form (conversion), starting from the conversion of uranium or thorium ore up to obtaining the material in the form of nuclear fuel or any other form allowing other applications of these materials, and spent nuclear fuel reprocessing and processing radioactive waste containing nuclear materials; 6

7 39) radioactive waste processing process or operation designed to minimize the volume of waste, waste segregation according to waste category and waste preparation for transport or disposal; 39a) predictable operating emergency an operating process that deviates from the normal operation, assumed to occur at least once during normal operation of a nuclear facility, which will cause no significant damage of the systems or of the construction or of equipment items that are important for the nuclear safety and will result in no emergency conditions provided specific design solutions are applied; 40) interventional radiology all therapeutic and diagnostic procedures, performed through the patient s skin or otherwise, performed under local or general anaesthesia and using fluoroscopic imaging to localize pathologic changes and for the purposes of radiological medical procedure monitoring, and also for the purposes of therapy control and documentation; 41) radiotherapy all therapeutic activities involving the use of radiological equipment, including: a) surface therapy for treatment of tumours localized in human skin, and deep therapy for treatment of tumours, and possibly some other pathologies, in organs and tissues in other locations (tele-radiotherapy), b) insertion of an isotopic source directly into the internal organs, into the tissues or body cavities, or its placement on the patient s body surface (brachytherapy), c) intentional introduction of therapeutic quantities of radiopharmaceutical products into the organism; 42) X-ray diagnostics all diagnostic activities involving the use of X-ray devices; 43) radioactive contamination contamination of objects, premises, environment or individuals by an unwanted presence of radioactive substance. In the special case of human body this includes both external and internal contamination, regardless of the radioactive substance intake pathway; 44) radioactive waste or spent nuclear fuel disposal emplacement of radioactive waste or spent nuclear fuel in an appropriate facility with no intention of retrieval; 45) radioactive substance substance containing one or more radioactive isotopes, with activity or radioactive concentration that may not be disregarded from the radiological protection viewpoint; 7

8 46) quality management system set of systematically planned and implemented actions, necessary to ensure adequately that a given structure, system or their components, or the procedures, will perform in an adequate way, fulfilling the requirements established in the regulations issued under Article 33c Section 9, Item 2; 47) human health detriment evaluated risk of shortening of human life and impairment of its quality, resulting from ionizing radiation exposure. Includes the losses resulting from somatic consequences, tumours and serious genetic disorders; 48) controlled area area with controlled access, covered by special regulations designed for the protection against ionizing radiation or radioactive contamination spreading; 49) supervised area area under special supervision for the purposes of protection against ionizing radiation; 49a) type of sealed radioactive source - catalogue symbol of a radioactive source or a set of structural features and physical parameters characterizing a point, surface and linear radioactive source, including the type of ionizing radiation used; 50) radiological equipment ionizing radiation sources or equipment for the detection of ionizing radiation, used for therapeutic or diagnostic purposes; 50a) emergency conditions deviations from the normal operation of a nuclear facility that are more severe than the predictable operating emergencies; 50b) design basis conditions normal operating conditions of a nuclear facility, predictable operating emergencies and design basis accidents, accounted for in the nuclear facility design, as per established design criteria and a reasonable approach; 51) spent nuclear fuel nuclear fuel that has been irradiated in a nuclear reactor core and permanently removed from the core; 52) isotopic enrichment process consisting in the separation of uranium isotopes for the purpose of increasing uranium-235 content in the final product; 53) hazardous situation (potential exposure) an exposure that can take place, and the probability of its occurrence can be estimated in advance; 54) closure of radioactive waste or spent nuclear fuel repository discontinuation of further shipments of radioactive waste or spent nuclear fuel to the repository, decided upon by an appropriate authority, and accomplishment of all works 8

9 necessary to ensure the safety and security of the repository; 54a) sealed radioactive source radioactive source of such design that under the conditions established for its use, the leakage of radioactive material contained in the source into the environment is prevented; 55) radiation emergency hazardous situation which requires urgent actions for the protection of workers or general public; 55 1 ) integrated management system a management system covering elements related to safety, health, environment, quality assurance, economic issues and physical protection, which considers the nuclear safety as a priority by making sure that all decisions are adopted on the basis of the results of nuclear safety analysis, radiological protection, physical protection and the protection of nuclear materials; 55a) orphan source - sealed radioactive source containing a radioactive isotope whose activity at the moment of source discovery exceeds the threshold activity level P 1 specified in Annex no 2 to the Act, and which has not been covered by the supervision and control of a nuclear regulatory authority from the nuclear safety and radiological protection viewpoint, or which has been so covered but control and supervision over the source have been lost, in particular due to abandonment, loss, theft or illegal transfer of the source 56) radioactive source radioactive substance made ready for the use of its ionizing radiation; 57) ionizing radiation source radioactive source, equipment containing such source, equipment generating ionizing radiation or equipment emitting radioactive substances; 58) high activity source sealed radioactive source containing a radioactive isotope whose activity at the moment of source manufacture or, if that value is unknown, at the moment when the source is introduced for sale, is equal to, or higher than, the threshold activity for a high activity source, as specified in Annex no 2 to the Act. Chapter 2 Licences pertinent to nuclear safety and radiological protection Article Any activity involving exposure and consisting in: 9

10 1) manufacturing, processing, storage, disposal, transport or use of nuclear materials, radioactive sources, radioactive waste and spent nuclear fuel, as well as the trade in these materials, and also isotopic enrichment, 2) construction, commissioning, operation and decommissioning of nuclear facilities, 3) construction, operation, closure and decommissioning of radioactive waste repositories, 4) production, installation, use and maintenance of the equipment containing radioactive sources and trade in such devices; 5) commissioning and use of the equipment generating ionizing radiation; 6) commissioning of laboratories and workrooms using ionizing radiation sources, including X-ray laboratories; 7) intentional addition of radioactive substances in the processes of manufacturing consumer products and medical devices, medical devices for in-vitro diagnostics, equipment for medical devices, equipment for medical devices for in-vitro diagnostics, active medical devices as defined in Act of Parliament on Medical Devices of 20 May 2010 (Journal of Laws of the Republic of Poland No 107 Item 679) and trade in such products, and also the import into the Republic of Poland s territory, and export from this territory, of consumer and medical products to which radioactive substances have been added; 8) intentional administration of radioactive substances to humans and animals, for the purposes of medical or veterinary diagnostics, therapy or research - shall require a licence or a notification from the viewpoint of nuclear safety and radiological protection, subject to Article 6 Item Activities consisting in adding radioactive substances to foodstuffs, toys, personal jewellery or cosmetic products, as well as the import of such products into the Republic of Poland s territory, and their export from this territory, shall be prohibited. Article Application to issue a licence for activities referred to in Article 4, Section 1 shall include: 1) designation of the organizational entity applying for the licence, as referred to in Article 4 Section 1, indicating its localization and address, 2) in case of entrepreneurs number in the entrepreneurs register, 10

11 3) description of the type, scope and place of conducting activities involving the exposure. 1a. An application shall be accompanied by the documents specified in the regulations issued under Article 6, Section An application to issue a licence for activities referred to in Article 4, Section 1, or the notification of such activities, shall be submitted by the head of the organizational entity. 3. A licence shall be issued by, or the notification shall be made to, the President of National Atomic Energy Agency, hereinafter referred to as the Agency s President, subject to Section A licence for commissioning and operation of X-ray devices for the purposes of medical diagnostics, interventional radiology, surface radiotherapy and non-cancerous disease therapy, and for commissioning of the laboratories using such devices, shall be issued by the state regional ( wojewódzki ) sanitary inspector, while for the organizational entities: 1) subjected or subordinated to the Minister of National Defence, or supervised or established by this Minister shall be issued by the commander of the military centre for preventive medicine, 2) subjected or subordinated to the minister competent for home affairs, or supervised or established by this minister shall be issued by the state sanitary inspector of the Ministry of Home Affairs and Administration. 5. A licence shall be issued, or the notification shall be accepted, after establishing that the conditions required by law for performing activities involving radiation exposure and requiring a licence or notification have been fulfilled. 5a. A licence for conducting activities involving a high activity source shall be issued provided that the organizational entity applying for the licence also concludes: 1) an agreement with the manufacturer or supplier of a high activity source under which the manufacturer or supplier undertakes to collect the source after the source-related activities have been terminated, and to ensure subsequent management of the source, and which regulates the terms of financial guaranty to cover the cost of source collection and management, or 2) an agreement with a state-owned public utility referred to in Article 114, Section 1, under which this company undertakes to collect the source after the sourcerelated activities have been terminated and to ensure subsequent management of 11

12 the source, and which regulates the terms of financial security to cover the cost of source collection and management. 5b. Financial security referred to in Section 5a, Item 2, may consist of the following: 1) single payment or regular payments made by the organizational entity which conducts activities involving a high activity source, to cover the cost of source collection and management to a separate, interest-bearing account of the stateowned public utility referred to in Article 114, Section 1, which serves solely for accumulating funds to cover such costs, or 2) bank pledge, bank guarantee, insurance guarantee or a bill of exchange guaranteed by the bank, submitted by the organizational entity, which conducts activities involving a high activity source, to the state-owned public utility referred to in Article 114, Section 1. 5c. The value of security shall not exceed the cost of collecting and managing a high activity source of a given type, as established in the price list referred to in Article 118, Section 2. 5d. Provisions of Section 5a shall not apply to activities consisting in the storage and disposal of a high activity source by the state-owned public utility referred to in Article 114 Section 1, and to the activities consisting in the transport of such source. 6. (repealed). 7. Licence shall be issued for an indefinite period, unless the organizational entity applying for the licence applies for the licence for a definite period. 7a. Issuance, denial or revocation of a licence, as well as the acceptance or refusal to accept a notification, shall have the form of an administrative decision. 7b. If necessary, the licence shall determine the conditions for conducting activities involving exposure. 8. Authorities referred to in Sections 3 and 4 shall establish and maintain the register of those organizational entities, whose activities require at least a notification. 9. Head of organizational entity shall report to the licensing body all changes concerning the data specified in the licence. 10. The provision contained in Section 9 shall apply, as appropriate, to the notification. 11. Licensing body shall revoke the licence in the event when: 1) a valid ruling has been passed, which prohibits the organizational entity to conduct activities involving exposure and covered by the licence, 12

13 2) an organizational entity ceased to fulfil the conditions required by law and necessary for the conduct of activities specified in the licence, 3) an organizational entity failed to eliminate, within the time specified by the licensing body, the factual or legal status, which does not comply with the conditions specified in the licence or with the legal provisions for activities covered by the licence; 4) an organizational entity has not complied with the sanctions imposed by the European Commission under the provisions of Article 83 of the Euratom Treaty. 5) an organizational entity failed to comply with any order or prohibition stated in Article 68, Section 1, or failed to implement the decision stated in Article 68b, Section A decision to revoke the licence should establish the method for managing the nuclear materials, ionizing radiation sources, radioactive waste or spent nuclear fuel held by the organizational entity. 13. Costs of the proceedings referred to in Section 12 shall be borne by the organizational entity, whose licence has been revoked. 14. A charge for issuing the licence shall be paid in the amount established in the regulations for financial charges and duties. 15. The Agency s President shall immediately submit to the Head of the Internal Security Agency the copies of administrative decisions on granting, refusing to grant or revoking the licence for the activities referred to in Article 4, Section 1. Article 5a. 1. An organizational entity which conducts activities that require a licence shall not transfer nuclear materials, radioactive sources, equipment containing such sources, radioactive waste nor spent nuclear fuel to an organizational entity which is does not hold a licence for conducting activities involving such materials, sources, devices, waste or spent nuclear fuel. 2. Provisions of Section 1 shall apply as appropriate to activities, which require notification. Article 5b. 1. Content of natural radioactive isotopes of potassium K-40, radium Ra-226 and thorium Th-228 in raw materials and materials used in buildings designed to accommodate people and livestock, as well as in industrial waste used in the construction 13

14 industry, shall not exceed the values established in the regulations issued under Article 6, Item Content of natural radioactive isotopes of potassium K-40, radium Ra-226 and thorium Th-228 in raw materials and materials used in buildings designed to accommodate people and livestock, as well as in industrial waste used in the construction industry, shall be controlled by the laboratories, which possess quality assurance system for performed tests, necessary equipment and premises, and participate, at their own cost, in interlaboratory benchmark measurements held by the Agency s President, as well as by the laboratories accredited to perform such control. 3. Control laboratories shall notify the construction supervision authorities if any limits defined in executive regulations issued on the basis of Article 6 Item 3 are exceeded. Article 6. The Council of Ministers shall establish by virtue of a regulation: 1) cases where activities referred to in Article 4, Section 1 shall be exempted from obtaining a licence or from issuing a notification, and the cases where such activities may be conducted on the basis of a notification, by defining appropriate exemption criteria in the form of limiting values for radioactive isotope total activity and radioactivity concentration; 2) documents required together with a licence application submitted for activities referred to in Article 4, Section 1, or with the notification of such activity, which are necessary to confirm that the applicant fulfils the conditions satisfying nuclear safety and radiological protection requirements, taking into account specific characteristics of various activities, as well as the actions of the authority issuing the licence or receiving the notification in the event that the content of such documents is insufficient to prove that these conditions have been fulfilled; 3) requirements concerning the content of natural radioactive isotopes of potassium K-40, radium Ra-226 and thorium Th-228 in raw materials and materials used in buildings designed to accommodate people and livestock, as well as in industrial waste used in construction industry, and the procedures for controlling the content of these isotopes, in particular the requirements imposed on laboratories conducting such control with regard to the quality assurance system for testing, equipment, premises, and the frequency of participation in inter-laboratory benchmark measurements, methods for taking samples and their measurements, and also the factors taken into account during the interpretation of measurement 14

15 results - with the aim to ensure effective protection of humans against the consequences of ionizing radiation from natural radioactive isotopes. Chapter 3 Nuclear safety and radiological protection, and health protection of the workers Article Responsibility for compliance with the requirements for nuclear safety and radiological protection shall rest with the head of organizational entity conducting the activities involving exposure. 2. Head of an organizational entity conducting activities for which a licence is required, shall develop and implement a quality assurance programme. 3. In an organizational entity conducting activities for which a licence is required, internal supervision over the fulfilment of radiological protection requirements shall be executed by an individual holding the authorization for radiological protection inspector. In an organizational entity conducting activities involving exposure and consisting in construction, commissioning, operation or decommissioning of nuclear facilities, an individual holding the authorization for radiological protection inspector shall also exercise internal supervision over the fulfilment of nuclear safety requirements. 4. The requirement referred to in Section 3 shall not be applicable to organizational entities conducting activities involving X-ray devices used for veterinary purposes, operated in picture mode, and to the organizational entity conducting activities involving X-ray equipment designed for supervision of people, shipments and luggage. 5. Internal supervision over the fulfilment of radiological protection requirements in X-ray laboratories using X-ray devices for the purposes of medical diagnostics, interventional radiology, surface radiotherapy and radiotherapy of non-cancerous diseases shall be exercised by an individual holding the authorization for radiological protection inspector in these X-ray laboratories. 6. The authorization referred to in Section 3 or 5 shall be granted to an individual who: 1) has full legal capacity; 2) is at least a secondary school graduate; 15

16 3) passed an examination with respect to the scope of training referred to in the regulations issued under Article 12b, Section 1 or Article 12b, Section 2; 4) holds a medical certificate on the absence of contraindications for work in occupational exposure conditions issued according to the executive regulations based on Article of the Labour Code Act of 26 June 1974 (Journal of Laws of 1998 No. 21, Item 94, with later amendments); 5) has worked in conditions of occupational exposure for the period established in the regulations issued under Article 12b, Section 1 or Article 12b, Section The training requirement referred to in Section 6, Item 3 shall not apply to an individual who: 1) holds an authorization for radiological protection inspector and applies for the same type of authorization on the day the application for being admitted to examination is submitted, or 2) has graduated within the last 5 years from studies at a higher education institution, involving dosimetry and radiological protection classes along with practical classes under exposure conditions, with minimum 30 hours of lectures and 30 hours of practical classes preceded with a lecture and practical classed in physics, including contemporary physics, or 3) has a higher education degree and at least three years of professional experience in working under exposure conditions at an organizational entity conducting activities for which a licence is required as set out in Article 4, Section 1, within the period of 5 years before the submission date of application for being admitted to the examination. 8. An application for granting the authorization referred to in Section 3 or 5 may be submitted by the applicant or the head of organizational entity. 9. The authorizations referred to in Sections 3 or 5 shall be granted for the period of 5 years. 10. The authorizations referred to in Section 3 shall be granted by the Agency s President in the form of an administrative decision. Depending on the type of activities involving exposure to be supervised by the radiological protection inspector, a suitable type of radiological protection inspector authorizations shall be granted. 16

17 11. The Agency s President shall keep a record of all entities authorized to hold trainings for persons applying to be granted authorizations stated in Section The authorizations referred to in Section 5 shall be granted by the Chief Sanitary Inspector in the form of an administrative decision. Depending on the type of activities involving exposure to be supervised by the authorized radiological protection inspector, a suitable type of radiological protection inspector authorizations shall be granted in X-ray laboratories using X-ray devices for the purposes of medical diagnostics, interventional radiology, surface radiotherapy and radiotherapy of non-cancerous diseases. 13. The Chief Sanitary Inspector shall keep a record of all entities authorized to hold trainings for persons applying to be granted authorizations stated in Section The records referred to in Sections 11 and 13 shall include: 1) entity name and address; 2) entity mailing address, telephone number, fax number and address; 3) information on types of trainings offered by the entity. 15. The record-keeping authority shall publish the data entered in registers referred to in Sections 11 and 13 on-line, on the official website of the Public Information Bulletin. 16. Authority competent to grant the authorizations referred to in Sections 3 or 5 shall revoke the authorizations by an administrative decision when: 1) the authorized individual has lost his/her full legal capacity; 2) based on the inspection referred to in Article 63, Section 1, the duties established in this Act and in the regulations issued under this Act are found to be non-performed or improperly performed by the individual in question. Article The Agency s President shall appoint an examination board composed of 12 to 14 individuals from among experts on nuclear safety and radiological protection. Two members of the examination board shall be appointed in cooperation with the National Defence Minister, another two members of the examination board shall be appointed in cooperation with the minister competent for home affairs. The examination referred to in Article 7, Section 6, Item 3 shall be conducted by an examination panel composed of 3 5 experts appointed by the chairman of the examination board. 17

18 2. The examination referred to in Article 7, Section 6, Item 3 shall be conducted by an examination board composed of 3 experts in radiological protection who shall be appointed and recalled by the Chief Sanitary Inspector. 3. The examination board members referred to in Section 16 shall receive remuneration for taking part in the examination panel and shall have travel and accommodation costs reimbursed according to the terms and conditions stated in Article of the Labour Code Act of 26 June If a professional soldier is examined, the examination panel for individuals applying for authorizations referred to in Article 7, Section 3 shall be joined by a member appointed by the Agency s President in cooperation with the National Defence Minister. 5. If any officer reporting to or supervised by the minister competent for home affairs is examined, the examination panel for individuals applying for authorizations referred to in Article 7, Section 3 shall be joined by a member appointed by the Agency s President in cooperation with the minister competent for home affairs. 6. Costs of the training, examinations and medical tests shall be borne by the applicant. Article The duties of radiological protection inspector and radiological protection inspector in X-ray laboratories using X-ray devices for the purposes of medical diagnostics, interventional radiology, surface radiotherapy and radiotherapy of non-cancerous diseases shall include supervision over the fulfilment of radiological protection requirements at the organizational entity, and in particular: 1) supervision over the performance of activities according to working instructions and over the records of nuclear safety and radiological protection, including those referring to the personnel and other individuals staying at the entity under conditions of exposure, save for radiological protection of patients undergoing therapy and diagnostics using ionizing radiation; 2) supervision over the fulfilment of conditions of authorizing personnel to exercise specific tasks, including on-the-job personnel trainings in nuclear safety and radiological protection; 18

19 3) development of a programme of dosimetric measurements in the work environment, measurement taking and recording of individual doses to be submitted to the head of the organizational entity for approval; 4) conducting preliminary personnel exposure assessment based on the results of individual dose measurements or dosimetric measurements in the work environment, to be submitted to the head of the organizational entity; 5) determining personal protection measures, dosimetric equipment and measurement equipment as well as other personnel protection equipment to be available at the organizational entity, supervising the proper operation of emergency signalling systems and labelling of places of work where sources of ionizing radiation are located; 6) cooperation with on-site occupational health and safety services, individuals in charge of the quality assurance programme, fire prevention and environmental protection services in all matters related to ionizing radiation protection; 7) submitting ionising radiation protection assessments to the head of the organizational entity, depending on the type of activities and authorizations granted; 8) applying to the head of the organizational entity to suspend activities under exposure conditions if the licence conditions or the nuclear safety and radiological protection requirements are violated, as well as reporting these emergencies to the authorities that issued the applicable licence; 9) supervision over activities conducted under on-site emergency plan if any radiation emergency takes place at the organizational entity; 10) supervising the handling procedures of radioactive sources, nuclear materials and radioactive waste if the organizational entity is under reorganization or is decommissioned; notifying the authorities that issued the respective licence of any violation of the nuclear safety and radiological protection in this respect. 2. The powers of radiological protection inspector and radiological protection inspector in X-ray laboratories using X-ray devices for the purposes of medical diagnostics, interventional radiology, surface radiotherapy and radiotherapy of noncancerous diseases shall include: 19

20 1) applying to the head of organizational entity to change the work conditions of the personnel, and in particular, if the individual dose measurement results make it justifiable; 2) providing the head of organizational entity with assessments of protective equipment and measurement devices in terms of the efficiency of the ionizing radiation protection measures and methods as well as effectiveness and correct application of the measurement equipment; 3) checking personnel qualifications for nuclear safety and radiological protection, submitting the assessment results to the head of organizational entity; 4) applying to the head of organizational entity to introduce changes in working instructions, unless the recommended changes have the potential to increase the established dose constraints. Article 7 3. Whenever a radiological protection inspector is referred to in this Act, this will mean a person holding licences referred to in Article 7, Section 3 and also a person holding licences referred to in Article 7, Section 5. Article 7a. Head of the organizational entity shall seek the radiological protection inspector s opinion on the issues related to the tests and checks of protective equipment and measuring instruments, including in particular: 1) assessment of the equipment relevant for radiological protection prior to its admission for use, 2) admission for use of new or modified ionizing radiation sources, from the radiological protection viewpoint, 3) frequency of checking the effectiveness of the radiological protection measures and techniques, 4) frequency of the measuring instruments calibration, verification of their operability and proper usage. Article Prior to the start of activities involving new types of ionizing radiation application, the head of organizational entity shall prepare a justification for the activity, which should demonstrate that scientific, economic, social and other benefits expected 20

21 from this activity will prevail over possible human health detriment and damage to the state of environment resulting from this activity. 2. In the event of some new and important circumstances concerning the effects of conducted activity, the head of organizational entity shall verify the justification of this activity, taking into account the same factors, as those required for the justification itself. Article 8a. Head of an organizational entity shall inform in writing the body, which has issued the licence or accepted the notification, of the anticipated organizational entity transformation or termination of its operation, and shall clear with this body, in writing, the rules for the management of held radioactive sources, nuclear materials or radioactive waste, and also, following the termination of the activity, at the expense of organizational entity, shall perform a dosimetric inspection and decontamination of the site where activity has been conducted and of its surroundings. Article Head of an organizational entity shall ensure that the activities are conducted according to optimization principle, which requires that after accounting in a reasonable way for economic and social factors - the number of exposed workers and members of the public shall be as low as reasonably achievable and the ionizing radiation doses received by them shall be as low as possible, subject to Article 33c. 2. Head of an organizational entity shall perform the assessment of the exposure of workers, and if the optimization analysis indicates such necessity shall establish for them further limitations of exposure in such manner, that the ionizing radiation doses received would not exceed established dose constraints. 3. If dose constraints are established in the licence, then the head of organizational entity shall report to the licensing authority any possible case of exceeding these values. Article 9a. 1. The Agency s President may include in the licence the obligation for the organizational entity to create a specialized organizationally separated radiological protection service, to assist a radiological protection inspector in performing the tasks in the field of radiological protection. 2. Specialized radiological protection service referred to in Section 1 may be shared by a number of organizational entities, if their heads so decide in a concluded agreement. 21

22 Article A worker may be employed in exposure conditions after an appropriately qualified medical practitioner, hereinafter referred to as an authorized medical practitioner, issues a certificate stating that there are no contraindications for such employment. 2. Qualifications of authorized medical practitioner, procedures for issuing and preserving such certificates, and the type and frequency of medical examinations for workers employed in exposure conditions, shall be determined by the provisions of Labour Law, unless otherwise provided for in this Act. Article Work involving nuclear material, ionizing radiation source, radioactive waste or spent nuclear fuel, and work within a nuclear facility shall be performed by personnel familiar with work-specific nuclear safety and radiological protection regulations, as well as having appropriate skills and qualifications gained during trainings referred to in Section Head of organizational entity shall be obliged to ensure, at least every 5 years, the preliminary and periodic trainings for workers on the nuclear safety and radiological protection issues, according to a training program developed by him/her, and with reference to nuclear facilities at intervals defined in the licence to conduct activities related to exposure and consisting in construction, commissioning, operation or decommissioning of nuclear facilities. Appropriate training shall be also given to workers participating in the transport of nuclear materials, radioactive sources, radioactive waste and spent nuclear fuel. 3. The trainings referred to in Section 2 shall address, in particular: 1) general radiological protection procedures and undertaken preventive measures, as related to the activities conducted by an organizational entity; 2) radiological protection procedures and undertaken preventive measures, as related to a specific workplace; 3) procedures of conducting workplace-specific tasks and activities; 4) information on the possible consequences of the loss of control over nuclear material, ionizing radiation source or radioactive waste involved in conducted activities; 5) in case of female workers also the information on the necessity to promptly notify the head of organizational entity of the pregnancy, and the 22

23 information on the risk of radioactive contamination of a breast-fed child when there is a possibility of radioactive contamination of mother s body. 6) for nuclear power plants trainings involving performance of tasks and activities using simulators of the actual nuclear installations operating at the given nuclear power plant, and for research reactors - trainings involving specialist software that imitate the operation of equipment and research reactor. Article 11a. 1. The head of organizational entity conducting activities involving exposure and consisting in commissioning, operation or decommissioning of nuclear facilities shall establish a professional qualification review board to hold examinations aimed at verifying the knowledge of personnel gained during trainings referred to in Article 11, Section The organizational entity conducting activities involving exposure and consisting in commissioning, operation or decommissioning of nuclear facilities cannot employ any individuals who failed to pass the examination referred to in Section 1. Article 11b. 1. The head of organizational entity conducting activities involving exposure and consisting in commissioning, operation or decommissioning of nuclear facilities shall draw up short-term personnel training plans at least once every 3 years, as well as long term personnel training plans at 10 year intervals. 2. The plans referred to in Section 1 shall be approved by the Agency s President Article In an organizational entity, a position important from the viewpoint of nuclear safety and radiological protection shall be occupied exclusively by an individual possessing an appropriate authorizations issued by the Agency s President. 2. The authorizations referred to in Section 1 shall be granted by the Agency s President, by way of administrative decision, to individuals who: 1) have full legal capacity; 2) hold a medical certificate on the absence of contraindications for work in occupational exposure conditions issued according to regulations issued under Article of the Labour Code Act of 26 June 1974; 23