Basic Safety Standards for Facilities and Activities involving Ionizing Radiation other than in Nuclear Facilities (FANR-REG-24) Version 1

Transcription

1 Basic Safety Standards for Facilities and Activities involving Ionizing Radiation other than in Nuclear Facilities (FANR-REG-24) Version 1 Definitions Article (1) For purposes of this regulation, the following terms shall have the meanings set forth below. Other capitalised terms used but not defined herein shall have the meaning ascribed to them in Article 1 of the Federal Law by Decree No. 6 of 2009 Concerning the Peaceful Uses of Nuclear Energy (the Law): Absorbed Dose The fundamental dosimetric quantity D, defined as _ d E D dm _ Where d E is the mean energy imparted by ionizing radiation to matter in a volume element and dm is the mass of matter in the volume element. Concentration Clearance Diagnostic Reference Level The radioactivity per unit mass of a material in which the radionuclides are essentially uniformly distributed. Removal of Radioactive Material or radioactive objects within authorised practices from any further Regulatory Control by the Authority. A level used in medical imaging to indicate whether, in routine conditions, the Dose to the patient or the quantity of Radioactive Material administered in a specified radiological procedure is unusually high or low for that procedure. Diagnostic Reference Levels are established following consultation with health competent authorities and relevant professional bodies and are based upon surveys or published values appropriate to the circumstances in the State. Dose Constraint A prospective and source-related restriction on the individual Dose from a Radiation Source, which provides a basic level of protection for the most highly exposed individuals from a Radiation Source, and serves as an upper bound on the Dose

2 in Optimisation of protection for that Radiation Source. For Occupational Exposures, the Dose Constraint is a value of individual Dose used to limit the range of options considered in the process of Optimisation. For Public Exposure, the Dose Constraint is an upper bound on the annual Doses that members of the public should receive from the planned Operation of any controlled Radiation Source. Effective Dose The quantity defined as a summation of the tissue Equivalent Doses, which is each multiplied by the appropriate tissue weighting factor where HT is the Equivalent Dose in tissue T and w is the tissue weighting factor for tissuet. T E E w T. H T T From the definition of Equivalent Dose, it follows that where w R is the radiation weighting factor for radiation R and is the average absorbed Dose in the organ or tissue. E wr. DT, R T R wt D T, R Equivalent Dose The quantity H T, R, defined as where D T, R is the Absorbed Dose delivered by radiation type R averaged over a tissue or organ T and is the radiation weighting factor for radiation type R: w R H T, R wr. DT, R When the radiation field is composed of different radiation types with different values of w the Equivalent Dose is: R H T wr. DT, R R Justification Medical Exposure The process of determining whether the conduct or a set of related conducts of a Regulated using Regulated Material is, overall, beneficial; that is, whether the benefits to individuals and to the society from introducing or continuing the conduct or conducts outweigh the resulting harm (including radiation detriment). Exposure incurred by patients for the purpose of medical or dental diagnosis or treatment; by carers and comforters; and by volunteers in a programme of biomedical research involving their exposure

3 Medical Physicist Medical Radiation Technologist Occupational Exposure Optimisation Planned Exposure Situation Protection and Safety A health professional (an individual licensed by the competent authorities of the State to practise a profession related to health), with education and specialist training in the concepts and techniques of applying physics in medicine, competent to practise independently in one or more of the subfields (specialities) of medical physics. A health professional (an individual licensed by the competent authorities of the State to practise a profession related to health), with specialist education and training in medical radiation technology, competent to carry out radiological procedures, on delegation from the Radiological Medical Practitioner, in one or more of the specialities of medical radiation technology. Exposure of Workers incurred in the course of their work, with the exception of excluded exposures and exposures from exempt practices or exempt sources. The process of determining what level of Protection and Safety makes exposures, and the probability and magnitude of potential exposures, as low as reasonably achievable, economic and social factors being taken into account (ALARA), as required by the International Commission on Radiological Protection System of Radiological Protection. A situation of exposure to Ionizing Radiation that arises from the planned Operation of a Radiation Source or from a planned that results in an exposure from a Radiation Source. The protection of people against exposure to Ionizing Radiation or Radioactive Material and the Safety of Radiation Sources, including the means for achieving this, and the means for preventing Accidents and for mitigating the consequences of Accidents should they occur. Qualified Expert An individual who, by virtue of certification by appropriate boards or societies, professional licences or academic qualifications and experience, is duly recognised as having expertise in a relevant field of specialisation Radiation Generator A device capable of generating ionizing radiation, such as X- rays, neutrons, electrons or other charged particles, that may be used for scientific, industrial or medical purposes. Radiation Protection A person technically competent in Radiation Protection matters

4 Officer relevant for a given type of Regulated with Regulated Material who is designated by the Licensee to oversee the application of relevant requirements established in this regulation. Radiological Medical Practitioner Radiopharmacist Referring Medical Practitioner Representative Person Safety Culture Supplier Worker A health professional (an individual licensed by the competent authorities of the State to practise a profession related to health), with education and specialist training in the medical uses of radiation, who is competent to independently perform or oversee procedures involving Medical Exposure in a given category. A health professional (an individual licensed by the competent authorities of the State to practise a profession related to health), with education and specialist training in radiopharmacy, who is competent to prepare and dispense radiopharmaceuticals used for the purposes of medical diagnosis and therapy. A health professional (an individual licensed by the competent authorities of the State to practise a profession related to health) who, in accordance with the requirements of the State, may refer individuals to a Radiological Medical Practitioner for Medical Exposure. An individual receiving a Dose that is representative of the more highly exposed individuals in the population. The assembly of characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, Protection and Safety issues receive the attention warranted by their significance. Any legal Person to whom a Licensee delegates duties, totally or partially, in relation to the Design, manufacture, production or Construction of a Radiation Source. An importer of a Radiation Source is considered a Supplier of a Radiation Source. Any person who works full-time, part-time or on a temporary basis for a Licensee and who has recognised rights and duties in relation to occupational Radiation Protection.

5 Objective and Scope Article (2) 1. This regulation defines requirements that all Licensees must comply with and follow with regard to the conduct, other than in a Nuclear Facility, of any of the following Regulated Activities with the Regulated Material referred to in Article 2(3): a. possession, use, manufacture or handling of any Regulated Material or part of any Regulated Material in the State; b. Storage of any Regulated Material within the State; and c. Disposal of any Regulated Material within the State. 2. Requirements for the Regulated of Transportation of Radiation Sources into or from the State are set out in the Licence Conditions. 3. For the purposes of this regulation, the definition of Regulated Material in Article 1 of the Law is interpreted as follows: a. the Radioactive Material designated by the Authority as being subject to Regulatory Control because of its radioactivity and hence subject to the requirements of this regulation is: Radioactive Material in a moderate amount (no more than one tonne) for which both the total radioactivity of an individual radionuclide present on the premises at any one time and the Concentration exceeds the applicable levels given in Table I -1 of Schedule I; Radioactive Material in a bulk amount for which the Concentration of a given radionuclide of artificial origin exceeds the relevant value given in Table I-2 of Schedule I, and/or the Concentration of any radionuclide in the uranium and thorium decay series exceeds 1 Bq/g or the Concentration of K40 exceeds 10 Bq/g; where there are mixtures of radionuclides, using the levels given in Tables I-1 and I-2, the condition for being subject to Regulatory Control is that the sum of the individual radionuclide activities or Concentrations, as appropriate, is greater than the derived level for the mixture ( X m), determined as follows: X m n 1 f ( i) X ( i i1 ) where f(i) is the fraction of or Concentration, as appropriate, of radionuclide i in the mixture, X(i) is the applicable level for radionuclide i as given in Table I-1 or Table I-2, and n is the number of radionuclides present; b. the sources of Ionizing Radiation designated by the Authority as requiring its direct oversight and hence subject to the requirements of this regulation are those devices

6 that generate Ionizing Radiation intended for application for medical, industrial, veterinary, legal, teaching, research, security, or agricultural purposes, including linear accelerators, cyclotrons, and fixed and mobile radiography equipment. Article (3) 1. The requirements in this regulation apply to Planned Exposure Situations in: a. Facilities that contain Radiation Sources, medical radiation Facilities, veterinary radiation Facilities, Radioactive Waste Management Facilities, installations processing Radioactive Material, irradiation Facilities, and mineral extraction and mineral processing Facilities that involve or could involve exposure to radiation or exposure due to Radioactive Material; and b. individual Radiation Sources, including Radiation Sources within Facilities referred to in (a). 2. The requirements in this regulation apply to Occupational Exposure, Public Exposure or Medical Exposure due to any of the Regulated Activities specified in Article 2(1) above. 3. The application of the requirements of this regulation shall be commensurate with the characteristics of the Regulated and with the magnitude and likelihood of the exposures. Article (4) 1. It is prohibited for any Person to conduct the Regulated Activities referred to in Article 2(1) unless licensed to do so by the Authority. 2. Any Person seeking to undertake the Regulated Activities referred to in Article 2(1) shall apply to the Authority for a Licence and submit detailed evidence of Safety as in accordance with the guidance published by the Authority. 3. In accordance with Article 23 of the Law, a Person seeking to undertake Regulated Activities in a Facility (other than a Nuclear Facility) shall make application to the Authority before, constructing or operating the Facility. Similarly, a Person already operating a Facility shall notify the Authority before shutting down or Decommissioning the Facility. In accordance with Article 1 of the Law, Facilities include... places where Radioactive Material is produced, processed, used, handled, stored, or disposed of, or where radiation generators are installed, on such a scale that consideration of Protection and Safety is required. For the purposes of this regulation such places include locations for radiotherapy, nuclear medicine, industrial irradiation, and predisposal radioactive waste management. The Authority may identify additional such places by notice published in the Gazette. 4. The Licensee shall notify the Authority of its intentions to introduce modifications to the conduct of the Regulated using Regulated Material for which they are licensed, whenever the modifications could have significant implications for Protection and Safety, and are not to carry out any such modification unless specifically authorised by the Authority.

7 Exemption from Regulatory Control Article (5) A Person may seek an Exemption by the Authority from the Regulatory Control of Regulated Material as defined in Article 2(3), including the need to obtain a licence, on the basis of the following criteria: 1. that in all reasonably foreseeable situations, the Effective Dose expected to be incurred by any member of the public due to the exempted Planned Exposure Situation is of the order of 10 microsieverts or less in a year and that for low probability scenarios the Effective Dose does not exceed 1 millisievert (msv) in a year; or 2. Regulatory Control of the Planned Exposure Situation would provide no net benefit, in that no reasonable control measures would achieve a worthwhile return in reduction of individual Doses or risks. Article (6) 1. Licensees may seek Clearance by the Authority on the basis that: a. radiation risks arising from the Radioactive Material requested to be cleared are sufficiently low so as not to warrant Regulatory Control and have no appreciable likelihood of occurrence of scenarios that could lead to a failure to meet the general criterion for clearance; or b. continued Regulatory Control of the material would yield no net benefit in that no reasonable control measures would achieve a worthwhile return in terms of reduction of individual doses or of health risks. 2. The Authority may grant Clearance of Radioactive Material under Article 6(1)(a) without further consideration provided that in all reasonably foreseeable situations the Effective Dose expected to be incurred by any member of the public due to the cleared material is of the order of 10 μsv or less in a year and for low probability scenarios that the Effective Dose expected to be incurred by any member of the public for such low probability scenarios does not exceed 1 msv in a year. 3. The Authority may grant Clearance of Radioactive Material without further consideration provided that: a. The Concentration of an individual radionuclide of artificial origin in solid form does not exceed the relevant level given in Table I-2 of Schedule I; or b. The Concentrations of radionuclides of natural origin do not exceed the relevant level given in Table I-3 of Schedule I; or c. For radionuclides of natural origin in residues that might be recycled into construction materials or the disposal of which is liable to cause the

8 contamination of drinking water supplies, the activity in the residues does not exceed specific values derived so as to meet a dose criterion of the order of 1 msv in a year, which is commensurate with typical doses due to natural background levels of radiation. 4. The Authority may grant Clearance for specific situations (on the basis of the criteria of Article 6(1) or 6(2) above) with account taken of the physical or chemical form of the Radioactive Material and its use or the means of its disposal. Such Clearance levels may be specified in terms of Concentration per unit mass or per unit surface area. 5. For clearance of Radioactive Material containing more than one radionuclide of artificial origin, on the basis of the levels given in Table I-2, the condition for clearance is that the sum of the individual radionuclide activity s is less than the derived Clearance level for the mixture ( X m), determined as follows: X m n 1 f ( i) X ( i i1 ) where f(i) is the fraction of or Concentration, as appropriate, of radionuclide i in the mixture, X(i) is the applicable level for radionuclide i as given in Table I-2, and n is the number of radionuclides present; 6. For Clearance of bulk quantities of material containing a mixture of radionuclides of natural origin and radionuclides of artificial origin, the conditions given in Article 6(3)(b) and Article 6(5) both have to be satisfied. Generic Requirements - Justification Article (7) 1. A Person seeking to undertake the Regulated Activities referred to in Article 2(1) must establish that the practice is justified. 2. With respect to the use of Ionizing Radiation in the imaging of humans for other than medical diagnosis or treatment, the Justification process shall consider: a. appropriateness of the radiation equipment for the proposed use; b. the use of alternative techniques that do not use Ionizing Radiation; c. the benefits and detriments of implementing the procedure; d. the benefits and detriments of not implementing the procedure; e. evaluation of various radiation technologies available, including the effectiveness and limitations of the procedures; f. availability of sufficient resources to safely conduct the imaging procedure during the intended period of use;

9 g. the impact of any legal or ethical issues which may be raised by the use of the technology. 3. Except for justified practices involving Medical Exposures, the following practices that result in an increase, by deliberate addition of Radioactive Material or by activation, in the radioactivity of the associated commodities or products, are deemed to be not justified: a. practices involving food, feed, beverages, cosmetics or any other commodity or product intended for ingestion, inhalation or percutaneous intake by, or application to, a human being; and b. practices involving the frivolous use of radiation or radioactive substances in commodities or products such as toys and personal jewellery or adornments. Optimisation and Dose Limits Article (8) 1. The Licensee shall ensure an optimised level of Protection and Safety for Workers so that the number of people exposed and the magnitude of the individual radiation Doses are as low as reasonably achievable (bearing in mind economic and social factors). 2. The Licensee shall determine a Dose Constraint for exposure of Workers taking into account international good practice in similar Facilities and Activities and shall Optimise protection below that nominated Dose Constraint. Where relevant, the Dose Constraint shall serve as a design target. Article (9) 1. The Licensee shall ensure an optimised level of Protection and Safety for members of the public so that the number of people exposed and the magnitude of the individual radiation Doses are as low as reasonably achievable (bearing in mind economic and social factors). 2. The Licensee shall determine a Dose Constraint for exposure of members of the public taking into account international good practice in similar Facilities and Activities, and shall Optimise protection below that nominated Dose Constraint. Where relevant, the Dose Constraint shall serve as a design target. 3. The public Dose Constraint determined in Article 9(2) shall be subject to the agreement of the Authority. Article (10) 1. The Licensee shall ensure that the normal exposure of Workers does not exceed the Dose limits established in Articles 10(2) and (3) below.

10 2. The limit for the Effective Dose to a Worker who is occupationally exposed is an average of 20 millisieverts per year averaged over a period of five years (100 msv in 5 years), and 50 msv in any one year. 3. The annual Equivalent Dose in the lens of the eye of a Worker shall not exceed 20 msv in a year, averaged over defined periods of 5 years, with no single year exceeding 50 msv, nor shall the annual Equivalent Dose exceed 500 msv at any point on the hands, feet or skin [Note: The equivalent dose limits to the skin apply to the average dose over 1 cm 2 of the most highly irradiated area of the skin]. 4. When a female Worker is occupationally exposed during normal Operation and has announced her pregnancy, the Licensee shall arrange her work so that the Equivalent Dose to the foetus is as low as reasonably achievable and shall not exceed 1 msv for the remainder of the pregnancy. Article (11) 1. The Licensee shall ensure that the normal exposure of the public does not exceed the Dose limits established in Article 11(2) below. 2. The limit for the annual Effective Dose to a member of the public (this includes people working in the Facility other than those categorised as Workers) is 1 msv. The annual Equivalent Dose in the lens of the eye shall not exceed 15 msv, nor shall the annual Equivalent Dose at any point on the skin exceed 50 msv. Management Requirements Article (12) 1. The Licensee has the prime responsibility for Protection and Safety, and shall establish and implement a Protection and Safety programme appropriate for the conduct of the Regulated. The Protection and Safety programme shall: a. The Protection and Safety programme shall be based on a documented Safety Assessment that identifies the sources of routine and reasonably foreseeable potential exposures; provides a realistic estimate of the resulting Doses and their probabilities; and identifies the resulting radiological protection measures that are needed. The Safety Assessment shall be proportionate to the complexity and radiation risks of the licensee s activities and may be generic; b. apply Protection and Safety measures commensurate with the nature and extent of the radiation risks associated with the Regulated and sufficient to ensure compliance with the requirements of this regulation and any Licence conditions that the Authority imposes; c. identify the role of the Radiation Protection Officer(s); and d. ensure that any delegation of responsibilities, including to Radiation Protection Officers, is documented.

11 2. The Licensee shall ensure that, in the implementation of the Protection and Safety programme: a. the measures and resources needed to achieve the Protection and Safety objectives are determined and duly provided; b. the Protection and Safety programme is periodically reviewed to assess its effectiveness and continued fitness for the purpose; and c. any failures or shortcomings in Protection and Safety are identified and rectified, and steps taken to prevent their recurrence. 3. The Licensee shall ensure that all personnel engaged in activities relevant to Protection and Safety are educated, trained and qualified so that they understand their responsibilities and perform their duties competently with appropriate judgment and according to defined procedures. 4. The Licensee shall ensure that Qualified Experts are identified and consulted, as necessary, on the proper observance of this regulation. 5. The Licensee shall establish a Quality Assurance programme as necessary as a part of its Management System to address Protection and Safety associated with Radiation Sources and the risk and complexity of the associated Activities. Article (13) 1. The Licensee shall demonstrate commitment to Protection and Safety at the highest levels within its organisation. The Licensee shall ensure that Protection and Safety are effectively integrated into its overall Management System, which shall be designed and implemented to enhance safety by: a. applying the requirements for Protection and Safety coherently with other requirements, including those for operational performance and for security; b. describing the planned and systematic actions necessary to provide adequate confidence that the requirements for Protection and Safety are satisfied; c. ensuring that Protection and Safety are not compromised by other requirements or demands; and d. providing for the regular Assessment of Protection and Safety performance and the application of lessons learned from experience. 2. The Licensee shall ensure that Protection and Safety aspects of the Management System are commensurate with the complexity and the radiation risks of the Regulated, as assessed through a Safety Assessment, and shall demonstrate the effective fulfilment of the Management System requirements for Protection and Safety. 3. The Licensee shall foster and maintain a strong Safety Culture as a part of its Management System by:

12 a. promoting individual and collective commitment to Protection and Safety at all levels of the organisation; b. ensuring a common understanding of the key aspects of Safety Culture within the organisation; c. providing the means by which the organisation supports individuals and teams in carrying out their tasks safely and successfully, taking into account the interaction between individuals, technology and the organisation; d. encouraging the participation of Workers in the development and implementation of policies, rules and procedures dealing with Protection and Safety; e. ensuring accountability of the organisation and of individuals at all levels for Protection and Safety; f. encouraging open communication within the organisation and with other relevant parties, as appropriate; g. encouraging a questioning and learning attitude and discouraging complacency with regard to Protection and Safety; and h. providing the means by which the organisation continually seeks to develop and improve its Safety Culture. 4. The Licensee shall take into account human factors and support good performance and good practices to prevent human and organisational failures, by ensuring that: a. sound ergonomic principles are followed in designing equipment and operating procedures, so as to facilitate the safe operation or use of equipment, to minimise the possibility that operating errors will lead to Accidents, and to reduce the possibility of misinterpreting indications of normal and abnormal conditions; b. appropriate equipment, safety systems, and procedural requirements are provided and other necessary provisions are made: to reduce, to as low as reasonably achievable, economic and societal factors being taken into account, the possibility that human error or inadvertent action could give rise to Accidents or other events causing exposures; to provide means for detecting human errors and for correcting or compensating for them; and to facilitate corrective actions in the event of failure of safety systems or of other protective measures. Article (14) 1. The Licensee shall establish and implement the necessary technical and organisational measures that are needed for ensuring Protection and Safety of the for which they are licensed. The Licensee may appoint other Qualified Experts to carry out actions and tasks related to these responsibilities, but are to retain the responsibility for the

13 actions and tasks themselves. The Licensee has to identify the Qualified Experts and other people appointed to ensure compliance with this regulation. 2. The Licensee shall: a. establish clear lines of responsibility and accountability for Protection and Safety of the Radiation Sources for which they are licensed throughout their Operational lifetime, and establish organisational arrangements for Protection and Safety; b. assess the likely consequences of potential exposures, their magnitude and probability of occurrence, and the number of people who may be affected by them; c. have in place operating procedures and arrangements to maintain Safety that are subject to periodic review and updating under the Management System; d. establish procedures for reporting and learning from Accidents and incidents; e. establish arrangements for the periodic review of the overall effectiveness of the Protection and Safety measures; f. ensure that Maintenance, testing, Inspection and servicing is carried out as needed so that Radiation Sources remain capable of meeting their Design requirements for Protection and Safety throughout their lifetime; and g. ensure safe control and management of all Radioactive Waste that is generated, in accordance with Article 30 of this regulation. Prevention of Accidents Article (15) 1. The Licensee shall ensure that a multilayer (defence in depth) system of provisions for Protection and Safety, commensurate with the magnitude and likelihood of the potential exposures involved, is applied to Radiation Sources for which they are authorised, such that a failure at one layer is compensated for or corrected by subsequent independent layers. 2. The Licensee shall make suitable arrangements to: a. prevent, as far as reasonably achievable, Accidents that have been postulated in connection with the Facility or ; b. mitigate the consequences of any Accident that does occur; c. provide Workers with the information, training, and equipment necessary to restrict potential exposures; d. ensure that there are adequate procedures for the control of the Facility and of any potential Accident that has been postulated; e. ensure that safety significant systems, including software, components and equipment can be inspected and tested regularly for any degradation that could lead to abnormal conditions or inadequate performance;

14 f. ensure that Maintenance, Inspection and testing appropriate to the preservation of the Protection and Safety provisions can be carried out without undue Occupational Exposure; g. provide, wherever appropriate, automatic systems for safely shutting off or reducing radiation output from Facilities in the event that operating conditions exceed the operating ranges; h. ensure that abnormal operating conditions that could significantly affect Protection and Safety are detected by systems that respond quickly enough to allow for timely corrective action to be taken; and i. ensure that all relevant safety documentation is available in the appropriate languages. Emergency Plan Article (16) 1. The Licensee shall prepare and maintain an Emergency Plan for protection of people, commensurate with the nature and magnitude of the risk involved. The Emergency Plan shall be subject to the approval of the Authority. 2. The Licensee shall be responsible for the implementation of the Emergency Plans and shall be prepared to take any necessary action for effective response. 3. To prevent the occurrence of situations that could lead to a loss of control over a Radiation Source or the escalation of such situations, the Licensee shall: a. develop, maintain and implement procedures to provide the means for preventing loss of control and regaining control over the Radiation Source as necessary; b. make available equipment, instrumentation and diagnostic aids that may be needed; and c. train personnel and periodically retrain them in the procedures to be followed.

15 Operating Experience Article (17) 1. The Licensee shall ensure that information on both normal Operation and abnormal circumstances significant to Protection and Safety is provided to the Authority. 2. The Licensee shall conduct formal investigations of abnormal circumstances arising in the operation of Facilities excluding Nuclear Facilities, or the conduct of Activities, and shall provide the Authority as soon as possible with information that is significant to Protection and Safety. 3. The Licensee shall conduct formal investigations and produce a written report in the event that: a. A quantity or operating parameter related to Protection and Safety exceeds an investigation level or is outside the stipulated range of operating conditions; or b. any equipment failure, Accident, error, mishap or other unusual event or circumstance occurs which has the potential for causing a quantity to exceed any relevant limit or operating restriction. 4. The Licensee shall: a. conduct an investigation as soon as possible after the event and produce a written report on its cause, with a verification or determination of any Doses received or committed and recommendations for preventing the recurrence of similar events; b. communicate to the Authority and to any other relevant competent authorities, a summary report of any formal investigation of events, including exposures greater than the Dose limits established in Articles 10 and 11 of this regulation; and c. report to the Authority (and other competent authorities as necessary) within 24 hours any event where the Dose limits established by Articles 10 and 11 of this regulation are exceeded. Safety of Generators and Radioactive Sources Article (18) 1. The Licensee shall ensure the Safety of radiation generators, Radioactive Sources, and devices containing a Radioactive Source. 2. Licensees, in co-operation with Suppliers, shall ensure that the following responsibilities are discharged: a. to provide a well designed and constructed radiation generator or Radioactive Source and device in which the radiation generator or Radioactive Source is used that: provides for Protection and Safety in compliance with this regulation; meets engineering, performance and functional specifications;

16 meets international safety standards; meets quality standards commensurate with the Protection and Safety significance of components, systems and software; and provides displays, dials and instructions on operating consoles in a language understood and acceptable to the user; b. to ensure that radiation generators and Radioactive Sources are tested to demonstrate compliance with the appropriate specifications; c. to make available information, in a language that is easily understood and acceptable to the user, concerning the proper installation and use of the radiation generator or Radioactive Source and its associated risks, including performance specifications, operating and Maintenance instructions, and Protection and Safety instructions. 3. When choosing a location to use or store a radiation generator or Radioactive Source, the Licensee shall take into account: a. factors that could affect the Safety and security of the radiation generator or Radioactive Source; b. factors that could affect the Occupational Exposure and Public Exposure caused by the radiation generator or Radioactive Source; and c. the feasibility in engineering Design of taking into account the foregoing factors. 4. When selecting a site for a Facility that will hold a large amount of Radioactive Material and has the potential for releases of large amounts of such Radioactive Material, the Licensee shall take into account any features that might affect Protection and Safety, features that might affect the integrity or function of the Facility, and the feasibility of carrying out off-site protective actions when they become necessary. 5. The Licensee shall keep radiation generators and Radioactive Sources secure so as to prevent loss, theft or damage and to prevent any unauthorised people from carrying out any of the regulated Activities specified in Article (2)(1). 6. The Licensee shall ensure that: a. a radiation generator or Radioactive Source is not transferred unless the receiver possesses the necessary authorization; b. the Authority is notified before the receipt or transfer of any radiation generator or Radioactive Source, including the type, form, and quantity of radiation generators or Radioactive Sources; and c. the Authority is notified of information regarding any uncontrolled, lost or missing radiation generator or Radioactive Source in accordance with the requirements in Article (19). 7. The Licensee shall maintain an inventory that includes records of: a. the location and description of each radiation generator or Radioactive Source for which they are responsible; and

17 b. the and form of each Radioactive Source for which they are responsible. 8. The Licensee shall: a. share appropriate information from their radiation generator or Radioactive Source inventory records with the Authority or other designated body when requested by the Authority; b. in cooperation with the manufacturer of a Radioactive Source or a device containing a Radioactive Source, ensure that, where practicable, the Radioactive Source itself and its container are marked with the symbol recommended by the International Organisation for Standardization (ISO); c. in cooperation with manufacturers, ensure that, where practicable, sealed Radioactive Sources are identifiable and traceable; d. ensure that when Radioactive Sources are not in use they are stored in an appropriate manner such that Protection and Safety is maintained; and e. ensure that arrangements are made for the safe management and disposition of Radioactive Sources, including financial provisions where appropriate, once they have become disused. Reporting Requirements Article (19) 1. Four Hour Report: The Licensee shall notify the Authority as soon as possible, but not later than after four hours of: a. the discovery of a loss of an Category 1, 2 or 3 Radioactive Source as defined in the IAEA Safety Guide RS-G-1.9 Categorization of Radioactive Sources ; b. an event that requires immediate protective actions necessary to avoid exposures to Ionizing Radiation or Regulated Materials that could exceed Dose limits; or c. releases of Regulated Material that could exceed regulatory limits (events may include theft, road Accidents, fires, explosions). d. an event that requires unplanned medical treatment at a medical facility of an individual with transferrable radioactive contamination on his or her clothing or body; e. Any event or situation, related to the health and safety of the public or onsite personnel or protection of the environment for which a news release is planned or notification to other government agencies has been or will be made. Such an event may include an onsite fatality or inadvertent release of radioactively contaminated materials. 2. Twenty-four hour report: The Licensee shall notify the Authority within 24 hours after the discovery of any of the following events involving Regulated Material:

18 a. loss of a Category 4 Radioactive Source as defined in the IAEA Safety Guide RS-G- 1.9 Categorization of Radioactive Sources; b. an unplanned contamination event that requires access to the contaminated area to be restricted for more than 24 hours by imposing additional radiological controls or by prohibiting entry into the area; c. an event in which equipment is disabled or fails to function as designed when the equipment is required to prevent releases or exposures exceeding regulatory limits, or to mitigate the consequences of an Accident, and no redundant equipment is available and operable to perform the required Safety function; d. an event that requires unplanned medical treatment at a medical facility of an individual with spreadable radioactive contamination on the individual's clothing or body; e. an Accident, fire or explosion that damages any Regulated Material or any device, container, or equipment containing Regulated Material when the quantity involved is equivalent to a Category 4 or greater Radioactive Source and the damage affects the integrity of the Regulated Material or its container; or f. an event where a Dose limit is exceeded. 3. One week report The Licensee shall notify the Authority within seven days after the discovery of any of the following events involving Regulated Material: a. any Discharges exceeding the authorised limits of Discharge in accordance with reporting criteria established by the Authority; or b. any significant increase in Dose rate or content of radionuclides in the environment that could be attributed to their authorised practice; 4. Thirty day report The Licensee shall submit to the Authority within 30 days any report required by Article (41) (4) (d) concerning unintended or Accidental Medical Exposures. 5. The requirements of this Article do not alter the Licensee s obligations to notify other relevant competent authorities in relation to an incident. Occupational Exposure - Responsibility of the Licensee for Optimisation of Protection and Safety Article (20) 1. The Licensee is responsible for the protection of Workers against Occupational Exposure and shall ensure that Protection and Safety is optimised and the Dose limits for Occupational Exposure are not exceeded. 2. Where persons who are not employed by the Licensee are subject to Occupational Exposure, the Licensee shall co-operate with the employer so that:

19 a. the measures for Protection and Safety applied for these persons are at least as good as for Workers of the Licensee b. there are specific assessments of the doses received by these persons, as appropriate c. there is a clear allocation of the responsibilities of the employer and those of the Licensee for Protection and Safety. As part of the co-operation between the Licensee and the employer, the Licensee shall, as appropriate: a. obtain from the employer, including self-employed individuals, the previous occupational history of the persons to be subject to Occupational Exposure by the Licensee and any other necessary information b. provide appropriate information to the employer, including any available information relevant for compliance with this regulation that the employer requests c. provide both the persons subject to Occupational Exposure and the employer with the relevant exposure records. 3. The Licensee shall ensure, for all Workers engaged in Activities that involve or could involve Occupational Exposure, that: a. Occupational Exposures are so controlled that the relevant Dose limits for Occupational Exposure specified in Article 10 are not exceeded; b. occupational Protection and Safety are Optimised; c. decisions regarding measures for occupational Protection and Safety are recorded and made available to the Authority; d. policies, procedures and organisational arrangements for Protection and Safety are established for implementing the relevant requirements of this regulation, with priority given to Design and technical measures for controlling Occupational Exposures; e. suitable and adequate Facilities, equipment and services for Protection and Safety are provided, the nature and extent of which are commensurate with the expected magnitude and likelihood of the Occupational Exposure; f. necessary Workers health surveillance and health services are provided; g. appropriate protective devices and monitoring equipment are provided and arrangements made for their proper use (as required in Articles 23 to 26 of this regulation; h. suitable and adequate human resources and appropriate training in Protection and Safety are provided, as well as periodic retraining and updating as required in order to ensure the necessary level of competence; i. adequate records are created and maintained as required by this regulation; j. arrangements are made to facilitate consultation and cooperation with Workers with respect to Protection and Safety about all measures necessary to achieve the effective implementation of this regulation; and

20 k. necessary conditions to promote a Safety Culture are provided as required by Article 13 of this regulation. l. Workers fulfil their obligations and carry out their duties for Protection and Safety and that they follow all rules and procedures for Protection and Safety specified by the Licensee; use monitoring equipment and personal protective equipment properly; cooperate with the Licensee with regard to Protection and Safety, to programme for Workers health surveillance, and to programme for dose assessment; provide the Licensee with information on their past and present work that is relevant for their own Protection and Safety as well as that of others; abstain from any wilful action that could create situations contrary to the requirements of this regulation; accept any information, instruction and training needed to enable them to work in accordance with this regulation. report to the Licensee as soon as possible any circumstances that could adversely affect Protection and Safety. 4. The Licensee shall ensure that Workers exposed to radiation from Radiation Sources within Activities that are not directly related to their work or not required by their work, receive the same level of protection as if they were members of the public. Controlled and Supervised Areas Article (21) 1. The Licensee shall designate as a controlled area any area in which specific protective measures or safety provisions are or could be required for: a. controlling normal exposures, b. preventing the spread of contamination during normal working conditions; or c. preventing or limiting the extent of potential exposures. 2. In determining the boundaries of any controlled area, the Licensee shall take account of the magnitudes of the expected normal exposures, the likelihood and magnitude of potential exposures and the nature and extent of the required Protection and Safety procedures. 3. The Licensee shall:

21 a. delineate controlled areas by physical means or, where this is not reasonably practicable, by some other suitable means; b. where a Radiation Source is brought into Operation or energized only intermittently or is moved from place to place, delineate an appropriate controlled area by means that are appropriate under the prevailing circumstances and specify exposure times; c. display the symbol for Ionizing Radiation recommended by the International Organisation for Standardization (ISO) and appropriate instructions at access points and other appropriate locations within controlled areas; d. establish occupational Protection and Safety measures including, as appropriate, physical measures and local rules and procedures for controlled areas to control the spread of contamination; e. restrict access to controlled areas by physical barriers, which could include locks or interlocks, or if necessary, by means of administrative procedures, such as the use of work permits, the degree of restriction being commensurate with the magnitude and likelihood of the expected exposures; f. provide, as appropriate, at entrances to controlled areas: protective clothing and equipment, individual and workplace monitoring equipment, and suitable Storage for personal clothing; g. provide, as appropriate, at exits from controlled areas: equipment for monitoring for contamination of skin and clothing, equipment for monitoring for contamination of any object or substance being removed from the area, washing or showering facilities, and suitable Storage for contaminated protective clothing and equipment; h. periodically review conditions to determine the possible need to revise the protective measures or safety provisions or the boundaries of controlled areas. 4. The Licensee shall designate as a supervised area any area not already designated as a controlled area but where Occupational Exposure conditions need to be kept under review even though specific protective measures and safety provisions are not normally needed. 5. The Licensee shall take into account the nature, likelihood and extent of radiation hazards in the supervised areas and: a. delineate the supervised areas by appropriate means; b. display approved signs at appropriate access points to supervised areas; and

22 c. periodically review the conditions to determine any need for protective measures and safety provisions or changes to the boundaries of supervised areas. 6. The Licensee shall minimise the need to rely on administrative controls and personal protective equipment for achieving Protection and Safety by maximizing the provision of well-engineered controls and satisfactory working conditions, in accordance with the following hierarchy of prevention principles: a. engineered controls; b. administrative controls; c. personal protective equipment. 1. The Licensee shall: Local Rules and Personal Protective Equipment Article (22) a. establish in writing such local rules and procedures as are necessary to ensure adequate levels of Protection and Safety for Workers and other people; b. include in the local rules and procedures the values of any relevant investigation level or authorised level, and the procedure to be followed in the event that any such value is exceeded; c. make the local rules and procedures and the protective measures and safety provisions known to those Workers to whom they apply and to other people who may be affected by them; d. ensure that any work involving Occupational Exposure is adequately supervised and take all reasonable steps to ensure that the rules, procedures, protective measures and safety provisions are observed; and e. designate, as appropriate, a Radiation Protection Officer. 2. The Licensee shall ensure that: a. Workers are provided with suitable and adequate personal protective equipment which meets relevant standards or specifications, including as appropriate: protective clothing, protective respiratory equipment for which the protection characteristics are made known to the users, and protective aprons and gloves and organ shields; b. when appropriate, Workers receive adequate instruction in the proper use of respiratory protective equipment, including testing for good fit;

23 c. tasks requiring the use of some specific personal protective equipment are assigned only to Workers who on the basis of medical advice are capable of safely sustaining the extra effort necessary; d. all personal protective equipment, including equipment for use in an Emergency, is maintained in proper condition and, if appropriate, is tested at regular intervals; and e. if the use of personal protective equipment is considered for any given task, account is taken of any additional exposure that could result owing to the additional time or inconvenience, and of any additional non-radiological risks that might be associated with performing the task while using protective equipment. Workplace Monitoring Article (23) 1. The Licensee shall establish, maintain and keep under review a programme for the monitoring of the workplace under the supervision of a Radiation Protection Officer or other Qualified Experts. 2. The nature and frequency of monitoring of workplaces shall: a. be sufficient to enable: evaluation of the radiological conditions in all workplaces; exposure Assessment in controlled areas and supervised areas; and review of the classification of controlled and supervised areas; and b. depend on the levels of ambient Dose rate and Concentration in air, including their expected fluctuations and the likelihood and magnitude of potential exposures. 3. The Licensee shall keep records of the findings of the workplace monitoring programme which shall be made available to Workers. Personnel Monitoring Article (24) 1. The Licensee shall be responsible for making arrangements for Assessment of the Occupational Exposure of Workers and for their health surveillance. 2. The Licensee shall be responsible for making arrangements for the Assessment of the Occupational Exposure of Workers, on the basis of individual monitoring, and shall ensure that adequate arrangements are made with approved/ licensed dosimetry services that operate under an adequate quality Management System and are approved by a certifying organisation acceptable to the Authority. 3. The Licensee shall ensure that individual monitoring is undertaken for any Worker who is normally employed in a controlled area, or who occasionally works in a controlled area