The Atomic Energy (Protection from Ionizing and Non-Ionizing Radiation) Regulations, 2023

Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) GOVERNMENT NOTICE NO. 840 published on 17/11/2023 THE ATOMIC ENERGY ACT, (CAP. 188) ______________ REGULATIONS ______________ (Made under section 70) THE ATOMIC ENERGY (PROTECTION FROM IONIZING AND NON- IONIZING RADIATION) REGULATIONS, 2023 ARRANGEMENT OF REGULATIONS Regulations Title PART I PRELIMINARY PROVISIONS 1. 2. 3. 4. 5. 6. 7. Citation. Application. Interpretation. PART II ADMINISTRATIVE REQUIREMENTS General obligations. Responsibilities for protection, safety and security. Responsibilities of Commission. Exemption of practices and sources. PART III NOTIFICATION AND AUTHORISATION 8. 9. 10. 11. 12. Requirements for notification. Requirements for authorisation. Requirements for authorisation of technical services. Authorisation and prescriptions of all forms by Commission. Renewal of authorisation. 1 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) 13. Modification, suspension and revocation of authorisation. 14. 15. Registration of qualified personnel performing radiation exposures. Transfer of radiation sources, disused radioactive sources, spent nuclear fuel and nuclear materials. Incidents and accidents. Reporting in case of incident or accident. Reporting. Investigations and feedback of operating experience. Research approval. Clearance of radiation sources. 16. 17. 18. 19. 20. 21. PART IV REQUIREMENTS FOR RADIATION PROTECTION 22. Justification of practices. 23. Optimisation of protection and safety. 24. Dose constraints. 25. Dose limits and reference level. 26. Management for protection and safety. 27. 28. Safety culture. Human factors. PART V VERIFICATION OF SAFETY Safety assessment. 29. 30. Monitoring and verification of compliance. 31. Inventory and records. PART VI HUMAN IMAGING FOR PURPOSES OTHER THAN MEDICAL DIAGNOSIS, MEDICAL TREATMENT OR BIOMEDICAL RESEARCH Justification of practices of any type of human imaging using radiation. Optimisation of protection and safety. 32. 33. 2 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) PART VII PLANNED EXPOSURE SITUATIONS 34. 35. 36. 37. Requirement for planed exposure situation. Emergency exposure. Existing exposure. Exclusion from requirements of these Regulations. (a) Occupational Exposure General responsibilities. Classification of areas. Occupational exposure assessment and records. Institutional rules, procedures and personal protective equipment. Radiation monitoring of workplace. 38. 39. 40. 41. 42. 43. Workers’ health surveillance. 44. 45. Information. Conditions of service. (b) Medical Exposure 46. 47. 48. 49. 50. 51. 52. 53. 54. 55. 56. 57. 58. 59. General responsibilities. Justification of medical exposure. Optimisation of protection for medical exposures. Calibration. Dosimetry of patients. Diagnostic reference levels. Quality assurance for medical exposure. Dose constraints. Pregnant or breast-feeding female patients. Release of patients after radionuclide therapy. Unintended and accidental medical exposures. Investigation of unintended and accidental medical exposures. Radiological reviews. Records of medical exposures. (c) Public Exposure 60. 61. General responsibilities. Exposure from multiple sources. 3 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) 62. 63. 64. Control of visitors. Sources of external irradiation. Control of discharge and contamination of radioactive materials accessible to members of public. 65. Monitoring of public exposure. 66. Consumer products. (d) Existing Exposures 67. Management of existing exposure situations. 68. 69. Remediation of areas with residual radioactive materials. Protection of emergency workers in emergency exposure situation. PART VIII RADIATION GENERATORS AND RADIOACTIVE SOURCES 70. 71. 72. 73. 74. 75. 76. 77. 78. 79. 80. 81. 82. 83. 84. 85. 86. 87. 88. General responsibilities. Design of radiation generators and radioactive sources. Supply and acquisition of radioactive sources. Storage of radioactive sources. Accountability on radioactive sources. Export of category 1 or 2 radioactive sources. Import of category 1 or 2 radioactive sources. PART IX RADIOACTIVE WASTE MANAGEMENT General responsibilities. Radioactive waste management facility or activities. Radioactive waste generation, characterisation and control. Control of radioactive waste generation. Reuse and recycle. Discharge of radioactive effluents. Radioactive waste not qualified for release, discharge or disposal. Classification and segregation of radioactive waste. Container labeling. Location of radioactive waste storage. Interim storage facility. Packaging of radioactive waste. 4 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) 89. 90. 91. 92. 93. 94. Disposal of radioactive materials. Screening of scrap metals. Quality assurance. Physical protection of radioactive wastes. Financing. Decommissioning of facilities and activities. PART X REQUIREMENTS FOR EMERGENCY PREPAREDNESS AND RESPONSE 95. 96. 97. 98. Responsibilities of registrants and licensees. Emergency preparedness and response. Implementation of intervention. Protection of emergency workers in emergency exposure situation. PART XI GENERAL PROVISIONS Cooperation between licensees, registrants and workers. 99. 100. Transport of radioactive materials requirements. 101. Revocation. ___________ SCHEDULES ___________ 5 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) THE ATOMIC ENERGY ACT, (CAP. 188) ______________ REGULATIONS ______________ (Made under section 70) THE ATOMIC ENERGY (PROTECTION FROM IONIZING AND NON-IONIZING RADIATION) REGULATIONS, 2023 PART I PRELIMINARY PROVISIONS Citation Application 1. These Regulations may be cited as the Atomic Ionizing and Non-Ionizing from Energy (Protection Radiation) Regulations, 2023. 2. These Regulations shall apply to- (a) activities involving the adoption, introduction, conduct, discontinuance or cessation of a practice, mining, extraction, processing, design, manufacture, sitting, construction or assembly, acquisition, import or export, distribution, locating, commissioning, possession, use and operation, maintenance or repair, selling, loaning, lending, letting, hiring or transfer of radiation sources; (b) decommissioning, transport, storage or disposal of radioactive materials, radiation generators or devices within a practice; disassembly, (c) non-ionizing radiation in the frequency range from 0 to 300 GHz; (d) all aspects of radioactive waste, spent nuclear fuel, disused sealed radiation sources arising 6 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) from medical, applications; and industrial and research (e) any other radiation practice which may be specified by the Commission. Interpretation In the context these Regulations, unless 3. otherwise requires- “laser product” means any manufactured product or assemblage of components, which constitutes, incorporates, or is intended to incorporate a laser or laser system, which emit electromagnetic radiations; and a laser or laser system that is intended for use as a component of an electronic product shall itself be considered as laser product; “source” means an apparatus, device, material or anything capable of emitting radiation; “unsealed source” means a radioactive source in which the radioactive material is neither permanently sealed in a capsule nor closely bonded and in a solid form; “sealed source” means a radioactive material that is permanently sealed in a capsule, or closely bonded and in a solid form; “container” means the vessel into which the waste is placed for handling, transport, storage or eventual disposal; also the outer barrier protecting the waste form from external intrusion; “referring medical practitioner” means health professional who, in accordance with national requirements, may refer radiological medical practitioner for medical exposure; individuals to a “radiological medical practitioner” means a health professional with specialist education and training in the medical uses of radiation, who is competent to perform independently or to oversee procedures involving medical exposure in a given specialty; “dose” means a measure of radiation received or absorbed 7 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) by a target; “dose constraint” means a prospective and source related value of individual dose that is used in planned exposure situations as a parameter the optimisation of protection and safety for the source, and that serves as a boundary in defining the range of options in optimisation; for “phantom” means a physical model containing tissue- equivalent material used to simulate the body in an experimental dose measurement; “existing exposure situation” means a situation that already exists when a decision on control has to be taken, including natural background radiation and residues from past practices that were operated outside the regulatory requirements; “technical services” includes personnel dosimetry services, individual and work place monitoring services, standard environmental monitoring services, radio analytical measurements, repair and maintenance of nuclear equipment and any other related services as determined by the Commission; calibration services, “device” means a manufactured product that produces radiation; “equipment” means manufactured products that produce radiation; “radioactive waste management facility” means facility specifically designed to handle, treat, condition, store or permanently dispose of radioactive waste; “reference level” means radiation exposure level provided for practical exposure assessment purposes to determine whether the basic restrictions are likely to be exceeded; “radiation generator” means a device capable of generating both ionising and non-ionising radiation including ultrasound equipment, magnetic resonance imaging 8 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (MRI), class 4 laser products, radio transmitters, radar stations, communication base stations, X-Ray equipment, and any other devices of similar nature that may be used industrial, communication, or medical purposes; for scientific, “containment” means the methods or physical structure designed to prevent the dispersion of radioactive substances; “conditioning” means preparation of disused radioactive sources or radioactive waste packages with the aim of placing them in a protective and safe structure for handling, transportation, storage or disposal; “radioactive waste” means some material that contains or is contaminated with radionuclides at concentrations or activities greater than exemption levels as established by the Commission and for which no use is foreseen; “spent nuclear fuel” means nuclear fuel removed from a reactor following irradiation, which is no longer usable in its present form because of depletion of fissile material, buildup of poison or radiation damage; “worker” means an employee who works, whether full time, part time or temporarily, for an employer and who has recognised rights and duties in relation to occupational radiation protection; “radiation” includes both ionising and non-ionising radiation; “laser radiation” means all electromagnetic radiation emitted by a laser product or laser sourcewithin the spectral range that is produced as a result of controlled stimulated emission or that is detectable with radiation so produced through the appropriate aperture stop and within the appropriate solid angle of acceptance; “occupational exposure” means an exposure to radiation 9 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) experienced by a worker in the course of performing his work; “safety case” means a collection of arguments and evidence in support of the safety of a facility or activity; “Act” means the Atomic Energy Act; “Commission” means the Tanzania Atomic Energy Commission established under section 5; Cap. 188 “treatment” means a process and method of changing the characteristics of the radioactive waste through volume reduction, removal of radionuclides from the radioactive waste or change of composition with the intention to benefit safety and economy; “quality assurance” means all those planned and systematic actions necessary to provide adequate confidence that an item, process or service will satisfy given requirements those specified in license; for example for quality, “surveillance” means monitoring of human exposure to radiation or monitoring of a radiation emitting source; “storage” means the holding of spent nuclear fuel or radioactive waste in a facility approved by the Commission that provides for its containment, with the intention of retrieval; “exposure limit” means an upper limit placed on human exposure to radiation to protect against adverse physiological responses that are causally related to radiation field, and such limits are not intended to provide protection against other effects arising from fear of such exposures; “security” means the prevention of, detection of, and response to, criminal or intentional unauthorised acts involving or directed at nuclear material, other radioactive material, facilities or activities; associated 10 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) “public” means the entire population excluding workers, members of the military or a patient under medical care, and includes individuals of all ages, and of varying health status, and articularly vulnerable groups or individuals such as the frail, elderly, pregnant workers, babies and young children; “discharge” means the direct release of effluents into the environment with subsequent dispersion; “waste management” means all activities, administrative and operational, that are involved in the handling, pretreatment, treatment, conditioning, transportation, storage and disposal of radioactive waste; the “installation” means a mounting or erection or assemblage that incorporates a source of radiation; “safety culture” means the assembly of characteristics and attitudes in organisations and individuals which establishes that, as an overriding priority, protection and safety issues receive the attention warranted by their significance; “clearance” means removal of radioactive materials or radioactive objects within authorised practices from any further control by the Commission; “waste package” means the product of conditioning that includes the waste form, any containers and internal barriers such as absorbing materials and liners, prepared in accordance with the requirements for handling, transport, storage or disposal; and “clearance levels” means the values established by the Commission and expressed in terms of activity concentration or total activity concentration, at or below the level which the source of radiation may be released from the control of the Commission. PART II ADMINISTRATIVE REQUIREMENTS 11 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) General obligations 4. A person shall not engage in activities, which involve practices, radiation generators, radioactive waste, unless the requirements of these Regulations are complied. Responsibilit ies for protection, safety and security 5.-(1) A licensee and registrant responsible for a facility or activity that gives rise to radiation risks shall have the prime responsibility for protection, safety and security. (2) Parties responsible for protection, safety and security are- (a) licensees or organisation activities; registrants, responsible the person or facilities and for (b) employers, in relation to occupational exposure; (c) radiological medical practitioners, in relation to medical exposure; (d) persons or organisations designated to deal with emergency exposure situations or existing exposure situations. (3) Other parties that have specified responsibilities in relation to protection, safety and security including: (a) suppliers of sources, providers of equipment and software, and providers of consumer products; (b) radiation protection officers; (c) referring medical practitioners; (d) medical physicists; (e) medical radiation technologists; (f) qualified personnel or any other party to whom a specific has assigned party principal responsibilities; (g) workers other than workers listed in regulation; and (h) law enforcers and other relevant regulatory authorities. (4) A licensee and registrant shall apply measures 12 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) for protection and safety that are commensurate with the radiation risks associated with the exposure situation. (5) A licensee and registrant shall ensure that, in the implementation of the protection, safety and security program include the following: (a) measures and resources that are necessary for achieving the objectives for protection and safety have been determined and are duly provided; (b) periodic review to assess its effectiveness and its continued fitness for purpose; (c) identified failures or shortcomings are corrected, and steps are taken to prevent their recurrence; (d) arrangements made to consult with interested parties; (e) record keeping and maintenance. (6) A licensee and registrant shall ensure that all personnel engaged in activities relevant to protection, safety and security have appropriate education, training and qualification. 6. The Commission shall- (a) review the monitoring programs of registrants and licensees; (b) review of periodic reports on occupational and public exposure including results of monitoring programs and dose assessments submitted by registrant and licensee; (c) provide maintaining exposure records and the assessment of doses from results of occupational exposure; (d) approve documents addressing the optimisation of protection and safety; (e) establish program for managing, controlling and recording in an emergency by emergency worker, which shall the doses received 13 Responsibilit ies of Commission Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) be implemented by response organisations and employers; (f) establish reference levels for exposure due to radionuclides in commodities; (g) enforce compliance with the dose limits and reference levels specified in Second and Eighth Schedules of these Regulations for public exposure; (h) approve dose constraints on dose and on risk, in consultation with professional bodies as appropriate, or establish or approve a process for establishing such constraints, to be used in the optimisation of protection and safety; (i) provide information on levels of indoors radon (j) exposure and the associated health risks; implementation of an action plan for controlling public exposure due to radon indoors; (k) evaluate the efficiency of the actions planned and implemented; (l) review and approve monitoring programs of registrant and licensee; (m) make provision for an independent monitoring programs; (n) make provision for maintaining records of discharges of radioactive materials, results of dose monitoring programs and results of assessments of public exposure; (o) verify the compliance of an authorised practice with the requirements for control of public exposure; (p) maintain source results monitoring, monitoring environmental programs and assessments of doses from public exposure; record of from (q) establish and provide information on levels of indoors radon and the associated health risks; 14 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (r) specify general principles for protection strategies to reduce exposure when remedial actions and protective actions have been determined; (t) (s) arrange for evaluation of the available remedial actions and protective actions for achieving the objectives; to assign responsibilities for the establishment and implementation of protection strategies to registrants, licensees and other parties involved in the implementation of remedial actions and protective actions; (u) specify the exposure situations that are included in the scope of existing exposure situations; (v) establish protection strategies for existing exposure situation which include the objectives to be achieved by means of the protection and appropriate reference levels; the involvement of (w) provide for interested parties in decisions regarding the development and implementation of protection strategies; (x) review periodically, the reference levels to ensure that they remain appropriate in the light of the prevailing circumstances; (y) ensure that the protection strategies for the management of existing exposure situations are established the radiation risks associated with the existing exposure situation; and commensurate with and (z) ensure that a strategy for radioactive waste management is put in place to deal with any waste arising from the remedial actions and that provision for such a strategy is made in the framework for protection and safety. Exemption of practices and 7.-(1) Practices and sources within a practice may be exempted from the specific safety requirements as 15 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) sources provided in these Regulations provided that they comply with criteria for exemption prescribed in the First Schedule of these Regulations. (2) Exemptions shall not be granted for practices deemed not to be justified as specified in these Regulations. (3) The following practices and sources within a practice safety requirements, including the requirements for notification, registration or licensing as provided in these Regulations. exempted specific from the are (a) radioactive materials in a moderate amount for which the total activity of a given radionuclide present on the premises at any one time or its activity concentration does not exceed the applicable exemption levels prescribed in First Schedule of these Regulations; activity (b) radioactive material in bulk amount for which the given concentration radionuclide of artificial origin used in the practice does not exceed the relevant value given in the First Schedule to these Regulations; (c) Magnetic Resonance Imaging (MRI) equipment of a other than for patients in the health sector; (d) non-ionising radiations practices which include Devices emitting electromagnetic radiation in the Ultra Violet (UV), laser sources in these spectral regions, infra red (IR) radiation, radio frequencies (RF) radiation in spectra range 1mm -1000km these regulations as prescribed in the Ninth Schedule to these Regulations. shall be exempted from PART III NOTIFICATION AND AUTHORISATION Requirement s for notification 8.-(1) A person who intends to carry out any of the actions specified in these Regulations shall submit a 16 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) notification to the Commission in a manner prescribed by the Commission. (2) After receipt of notification as specified in subregulation (1) the Commission shall inform the person if the actions require authorisation. Requirement s for authorisation 9.-(1) A person who intends to carry out any activities specified in these Regulations shall apply to the Commission for authorisation through registration or licensing. (2) A person who applies for authorisation shall- (a) submit an application form as prescribed by the Commission with documents necessary to support the application as required in the form; (b) assess the nature, likelihood and magnitude of the expected exposures due to the source and take measures for protection, safety and security; (c) submit a radiation safety and security plans; (d) submit appropriate prospective assessment made impacts, risks for commensurate with associated with the facility or activity; environmental radiological radiation the (e) provide qualifications in radiation protection of the persons dealing with the radiation sources; (f) submit the report of and consultation with public and other interested parties that will be affected by activity or facility; and information GN. No. 478J of 2022 (g) pay license fee as prescribed in the Atomic Energy (Fees and Charges) Regulations, 2022. (3) Notwithstanding the provision of subregulation (2) an application for authorisation of a radioactive waste management or interim storage facility shall specify the following: (a) the quantity, type and characteristic of 17 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) radioactive waste, spent nuclear fuel or disused sealed radiation sources to be managed; (b) the suggested operation of the proposed facility or activity and equipment the radioactive waste, spent nuclear fuel or disused sealed radiation sources (DSRS); to manage (c) a safety case; (d) a proposed destination for the disposal of the radioactive waste, spent nuclear fuel or disused sealed radiation sources (DSRS); (e) a proposed system for record keeping; (f) contingency plans in the event of emergency; (g) proposal for discharge and environmental monitoring; and (h) any other details the Commission may consider necessary for the purpose. (4) Applications involving for authorisations Category 1 to 5 radioactive sources shall describe arrangements for the safe management of the sources, including declaration of financial soundness and provisions for return of the source to the Country of origin once they have become disused. (5) A licensee or registrant shall apply for authorisation to transport Category 1 to 5 radioactive material, minerals containing radioactive materials, nuclear materials, and Naturally Occurring Radioactive Materials (NORMs) within or on transit through Tanzania and pay fees in accordance with the Atomic Energy (Fees and Charges) Regulations, 2022. GN. No. 478J of 2022 (6) The Commission may impose conditions or limitations, as it may deem fit or necessary in any particular case. Requirement s for authorisation of technical 10.-(1) A person who intends to carry out any technical services specified in these Regulations shall apply to the Commission for authorisation in terms of registration 18 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) services or licensing. (2) A person who applies for authorisation for technical services shall- (a) submit an application form and supporting documents as prescribed by the Commission to be appropriate; (b) assess the nature, likelihood and magnitude of the expected exposures due to the source and take measures for protection, safety and security; (c) submit a plan for safety, radiation protection, waste management or security depending on the nature of activity; (d) provide a certificate in radiation protection from a recognised institution of the persons who will be providing technical services; and (e) pay license fee as prescribed in the Atomic Energy (Fees and Charges) Regulations, 2022. GN. No. 478J of 2022 Authorisation and prescriptions of all forms by Commission 11.-(1) Where the Commission is satisfied that the applicant has complied with the conditions specified under regulation 9, the Commission shall grant the authorisation as follows: (a) in case of authorisation to import, export and transport of radiation sources, its validity shall not exceed twelve months; (b) incase of authorisation to use or possess radiation source and radiation premise, the validity for authorisation shall be for the interval of a fiscal year; (c) in case of authorisation to use, possess, generate, transport, import, export, dispose, produce, manufacture of products, distribute products, store, transfer, extract any material containing naturally occurring radioactive material and any other related activities as may be specified by 19 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) the Commission and provider of technical services, the validity for authorisation shall be three years; (d) in case of authorisation to prospect radioactive minerals, sitting and construction of a mining or processing facilities, mining or processing of radioactive minerals, transport of concentrate radioactive minerals, decommissioning of a mining or processing facilities the ores, the validity for authorisation shall be as prescribed in the mining license issued by the Ministry responsible for mining. (2) For the purposes of implementing the provisions of these Regulations, the Commission may prescribe all and applications, forms authorisations issued under these Regulations. notifications relating to Renewal of authorisation 12. A licensee or registrant may apply for renewal of the authorisations of the license three months prior to the expiry date of License. Modification, suspension and revocation of authorisation 13.-(1) The Commission may modify, suspend or revoke an authorisation where the Commission- (a) find an undue threat to health, safety or non- compliance with applicable requirements; (b) receives an application for modification from licensee or registrant. (2) The licensee or registrant may apply for authorisation for modification as prescribed in regulation 8. Registration of qualified personnel performing radiation exposures 14.-(1) Every qualified personnel or expert intending to- (a) administer radiation to person for the purposes of diagnosis or treating a disease; or (b) install, operate, handle, maintain, repair radiation sources or devices, 20 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) GN. No. 478J of 2022 shall be registered or licensed by the Commission. (2) Subject to the provisions of subregulation (1) the qualified personnel or expert shall- (a) submit to the Commission an application form as prescribed by the Commission; (b) pay a license application fee as prescribed in the Atomic Energy (Fees and Charges) Regulations, 2022; (c) submit a certificate of radiation protection course from a recognised institution. (3) The authorisation for qualified personnel or expert shall be valid for period of five years. (4) A person justifying medical exposures to patients for diagnosis or therapy shall be a medical practitioner or dentists. Transfer of radiation sources, disused radioactive sources, spent nuclear fuel and nuclear materials Incidents and accidents 15.-(1) In the event the licensees or registrant decides to transfer the radiation sources, disused sealed radioactive source, spent nuclear fuel and nuclear materials to any other person, the licensees or registrant shall obtain an authorisation from the Commission prior to the transfer. (2) The licensees or registrant shall ensure that the person to whom the radiation sources, disused sealed radioactive source, spent nuclear fuel and nuclear materials is to be transferred has a valid license or registration. 16. In the event of an incident or accident, licensees and registrants shall- (a) investigate the incident or accident and its causes, circumstances and consequences; (b) take appropriate the action circumstance and to prevent a recurrence of similar situations; remedy to (c) take whatever other actions necessary as required by these Regulations. 21 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Reporting in case of incident or accident 17.-(1) A licensee or registrant shall- (a) notify the Commission by appropriate and fastest means such as telephone, facsimile, e- mail immediately of any event in which a dose limit or reference level is exceeded; (b) notify the Commission by telephone, facsimile, e-mail within twenty four hours of the discovery of any significant unintended or accidental medical exposures; (c) submit to the Commission, within thirty days after discovery of any significant unintended or accidental exposures, a written report which states: and (i) the cause of any significant unintended or includes exposures accidental information on the doses, corrective measures, preventive actions taken or to be taken and any other relevant information; the monitoring results at approved intervals; exposure (ii) summary public of (iii) discharges of radioactive waste to the environment at intervals as may be specified in the license and promptly report any discharges exceeding the authorised limits; and (iv) any releases of radioactive material to the environment above the clearance criteria established in these Regulations; (d) promptly inform the Commission of any abnormal results which lead or could lead to an increase of public exposure. (2) In addition to the radiation safety report, licensee and registrant shall report to the Commission and the police station within twenty four hours on- (a) loss of control over a radioactive source; (b) unauthorised access to, or unauthorised use of, a 22 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) source; (c) discovery of any orphan sources; and (d) actual or attempted theft of sources. Reporting 18. A licensee or registrant shall report to the Commission on- (a) radioactive source inventory and subsequent changes to those data, except for routine movements of the source allowed in the authorisation; data (b) any intentions to introduce modifications to any practice with a radioactive source whenever the modifications significant could implications for safety; (c) measures addressing protection and safety; the optimisation of have Investigation s and feedback of operating experience on- (d) a copy of relevant parts of any contract or acceptance document relating to the return to the supplier of radioactive sources intending to be imported. 19.-(1) The licensee or registrant shall investigate (a) quantity or operating parameters relating 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 condition that may occur has the potential for causing a quantity to exceed any relevant limit or operating restrictions. (2) The licensee or registrant shall prepare and submit to the Commission and other relevant parties, a written report on normal operation performance as well as abnormal conditions and events significant to radiation including safety, suspected causes, its causes or 23 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) determination of any doses received or committed and recommendations for preventing the recurrence of the event and the occurrence of similar events. Research approval 20. A person or organisation intending to carry out research work related to peaceful application of nuclear technology shall apply to the Commission for approval by- GN. No. 478J of 2022 Clearance of radiation sources (a) submitting an application form with relevant information to support the application including the research proposal; (b) paying for fees as prescribed in the Atomic Energy (Fees and Charges) Regulations, 2022. 21.-(1) Radiation sources, including substances, materials, radioactive waste and objects within notified or authorised practices can be further released compliance with the radiation protection and safety requirements provided that they comply with criteria for clearance in First Schedule to these Regulations or clearance levels established by the Commission. from (2) A person shall not clear materials from licensed facilities and activities or from unlicensed contaminated land or facilities unless it is approved by the Commission. PART IV REQUIREMENTS FOR RADIATION PROTECTION Justification of practices 22.-(1) No practice shall be authorised unless it is likely the exposed to produce sufficient benefit individuals or to society to offset the radiation harm that it might cause, taking into account social, economic and other relevant factors. to (2) The applicant for an authorisation shall provide sufficient information and evidence on the benefits and the harm to support the justification of the practice or source. (3) The following practices shall be deemed to be 24 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) not justified: (a) practices, except for justified practices involving medical exposure, that result in an increase in activity, by the deliberate addition of radioactive substances or by activation, in food, feed, fertilizer, beverages, cosmetics or any other commodity or product intended for ingestion, intake by, or inhalation or percutaneous application to, a person; (b) practices involving the frivolous use of radiation or radioactive substances in commodities or in products such as toys and personal jewelry or adornments, which result in an increase in activity, by the deliberate addition of radioactive substances or by activation; (c) human imaging using radiation that is performed as a form of art or for publicity purposes; for imaging using radiation (d) human theft detection purposes; (e) human imaging using radiation for the detection anti-smuggling concealed objects for of purposes; and (f) human imaging using radiation that is performed for occupational, legal or health insurance purposes, and is undertaken without reference to clinical indication. (4) Where, in exceptional circumstances, the Commission decides that the justification of such human imaging for specific practices is to be considered, such practice shall comply with regulation 33. (5) Human imaging using radiation for the detection of concealed objects that can be used for criminal acts or to pose a national security threat shall be justified only by the Government. Optimisation 23.-(1) A licensee or registrant shall ensure that 25 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) of protection and safety protection and safety is optimised for occupational and public exposure. (2) A licensee and registrant shall ensure that all relevant factors are taken into account in a coherent way in the optimisation of protection and safety to achieving the following objectives: are optimised (a) to determine measures for protection and safety prevailing that circumstances, with account the available options for protection and safety as well as the nature, likelihood and magnitude of exposures; taken of the for (b) to establish criteria, on the basis of the results of the optimisation, for the restriction of the likelihood and magnitudes of exposures by means of measures for preventing accidents and for mitigating the consequences of those that may occur; registrant shall ensure (c) for occupational and public exposure, licensee and relevant constraints are used in the optimisation of protection and safety for any particular source within a practice. that Dose constraints 24.-(1) For occupational and public exposure, licensee and registrant shall ensure relevant constraints are used in the optimisation of protection and safety for any particular source within a practice. (2) In case of any source that can release radioactive material to the environment, the dose constraints shall be established by licensee or registrant, so that the prospective annual doses to workers summed over all exposure pathways, including contributions by other practices and sources, are unlikely to exceed the dose limits specified in the Second Schedule to these Regulations. 26 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Dose limits and reference level 25.-(1) A licensee or registrant shall ensure that the exposures of individuals due to the authorised practices are restricted so that neither the effective dose nor the equivalent dose to tissues or organs exceeds any relevant dose limit or reference levels specified in Second, Fourth and Eighth Schedules to these Regulations. (2) The dose limits or reference levels shall not apply to medical exposures from authorised practices. (3) A licensee and registrant shall ensure that exposure limits are in conformity with those of the Commission and International Commission on Non- (ICNIRP) which are Ionizing Radiation Protection recommended by World Health Organisation (WHO), to protect workers and general public against excessive exposure to non ionising radiations. Management for protection and safety 26.-(1) The licensee and registrant shall ensure that protection and safety is effectively integrated into the overall management system of the organisations for which they are responsible. (2) The licensee and registrant shall establish a management system, commensurate with the size and nature of the authorised activity, which ensures that- (a) policies and procedures are established that identify safety as being of the highest priority; (b) problems affecting protection and safety are promptly identified and corrected in a manner commensurate with their importance; (c) the responsibilities of each individual for safety are clearly identified and each individual is suitably trained and qualified; (d) clear lines of authority for decisions on safety are defined; (e) Organisational arrangements and lines of communications are established that result in an appropriate flow of information. 27 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (3) The registrants and licensees shall ensure that the management system is designed and implemented to enhance protection, safety and security by- (a) applying the requirements for protection and requirements safety coherently with other including operational for performance, and coherently with guidelines for security; requirements (b) describing the planned and systematic actions necessary to provide adequate confidence that the requirements for protection and safety are fulfilled; (c) ensuring radiation protection is not that (d) providing compromised by other requirements; the regular assessment of performance for protection and safety and the application of lessons learned from experience; for Safety culture (e) promoting safety culture; and (f) ensuring confidentiality of information that it receives from another party is protected. (4) The licensee and registrant shall ensure that the protection, safety and security elements of the management system are commensurate with the complexity of and the radiation risks associated with the activity. 27. The licensee and registrant shall promote and maintain a safety culture by- (a) promoting individual collective commitment to protection and safety at all levels of the organisation; and (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, with account taken of the interactions between individuals, 28 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) technology and the organisation; (d) encouraging the participation of workers, their representatives and other relevant persons 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 with regard to protection and safety within the organisation and with relevant parties, as appropriate; (g) encouraging a questioning and learning attitude and discouraging complacency with regard to protection and safety; and (h) providing means by which the organisation continually seeks to develop and strengthen its safety culture. 28.-(1) The licensee and registrant shall ensure that all personnel on whom protection and safety depend are appropriately trained and qualified so that they understand their duties with their appropriate judgment and according to defined procedures, and are periodically re-trained or re-qualified as may be appropriate. responsibilities and perform (2) The licensee and registrant shall follow sound ergonomic principles in the design of equipment and the development of operating procedures, so as to facilitate the safe operation and use of equipment, to minimise the possibility that operator errors will lead to accidents, and to reduce the possibility that indications of normal conditions and abnormal conditions will be misinterpreted. (3) The licensee and registrant shall provide appropriate equipment, safety systems and operational procedural which- 29 Human factors Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (a) reduce, as far as practicable, the possibility that human error or inadvertent action could give rise to accidents or other incidents leading to the exposure of any person; (b) provide means for detecting human errors and for correcting or compensating them; (c) facilitate protective and corrective actions in the event of failures of existing safety systems or failures of existing measures for protection and safety. PART V VERIFICATION OF SAFETY Safety assessment 29.-(1) The licensee and registrant shall submit a the safety assessment which shall be reviewed by Commission. (2) The licensee and registrant shall conduct a safety assessment that is either generic or specific to the practice or source for which they are responsible. including (3) Safety assessments shall be conducted at different stages the stages of site design, manufacture, construction, assembly, commissioning, operation, maintenance and decommissioning or closure of facilities or parts thereof, as appropriate, for the purpose of- (a) identifying the ways in which exposures could be incurred, account being taken of the effects of external events as well as of events directly involving the sources and associated equipment; likelihood and magnitudes of exposures in normal operation and, to the extent reasonable and practicable, to make an assessment of potential exposures; (c) assessing the adequacy of the provisions for (b) determining the expected protection and safety. (4) The safety assessment shall include, as 30 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) appropriate, a systematic critical review of- (a) operational limits and conditions for the operation of the facility; (b) ways structures, in which systems and components, including software, and procedures relating to protection and safety might fail, singly or in combination, or might otherwise give rise to exposures, and the consequences of such events; (c) determining likelihood and magnitudes of exposures in normal operation and, to the extent reasonable and practicable, to make an assessment of potential exposures; (d) assessing the adequacy of the provisions for the expected protection, safety and security; (e) ways in which external factors could affect protection and safety; (f) ways in which operating procedures relating to protection and safety might be erroneous, and the consequences of such errors; (g) implications for protection and safety of any modifications; (h) any uncertainties or assumptions and their implications for protection and safety. (5) The registrant or licensee shall take into account in the safety assessment- (a) factors that could give rise to a substantial release of radioactive material, the measures available to prevent or to control such a release, radioactive and material that, in the event of a major failure of the containment, could be released to the environment; the maximum activity of (b) factors that could give rise to a smaller but continuing release of radioactive material, and the measures available to detect and to prevent 31 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) or to control such a release; (c) factors that could give rise to unintended operation of any radiation generator or a loss of shielding, and the measures available to detect and to prevent or to control such occurrences; (d) the extent to which the use of redundant and diverse safety features that are independent of each other, so that failure of one does not result in failure of any other, is appropriate to restrict the likelihood and magnitude of potential exposures. Monitoring and verification of compliance 30.-(1) The licensee and registrant shall conduct monitoring to verify compliance with the requirements for protection and safety. (2) The licensee and registrant shall submit to the Commission for review and authorisation its monitoring and measurement programs. (3) The licensee and registrant shall ensure that- (a) monitoring and measurements of parameters are performed as necessary for verification of compliance with the requirements of regulations and license conditions; (b) suitable equipment is provided and procedures for verification are implemented; (c) equipment is properly maintained, tested and calibrated at appropriate intervals with reference to standards traceable to national or international standards; (d) records of the results of monitoring and verification of compliance that include records of the tests and calibrations carried out are maintained; (e) the results of monitoring and verification of compliance are shared with the Commission as required; 32 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (f) routine compliance inspections are conducted at least once in every year for high risk radiation facilities, once in two years for medium risk radiation facilities, and once in three to five years for low risk radiation facilities. Inventory and records 31.-(1) The licensee and registrant shall maintain records and make available to the Commission whenever they are required. (2) The records in subregulation (1) shall include information relating to- (a) inventory of sealed sources, unsealed sources and radiation generators; (b) records of doses from occupational exposures; (c) records relating to facilities and activities; (d) inventory of radioactive waste; (e) records of events, including non-routine release of radioactive material to the environment; necessary decommissioning or closure of facilities; that might (f) records for be the- (g) transfer of radioactive sources; (h) testing of instruments and safety systems, and calibrations carried out in accordance with the requirements of these Regulations. (3) Individual sealed source records shall include (a) location of the source; (b) radionuclide; (c) radioactivity on a specified date; (d) serial number or unique identifier; (e) chemical and physical form; (f) source use history, including recording all movements into and out of the storage location; (g) receipt, transfer or disposal of the source; (h) other information, as appropriate, to enable the source to be identifiable and traceable; and 33 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (i) chemical and physical form. (4) The licensee and registrant shall keep a system for recording information on the generation, characteristics; processing, conditioning, storage, transportation and disposal of the waste, spent nuclear fuel and disused sealed radiation sources. PART VI HUMAN IMAGING FOR PURPOSES OTHER THAN MEDICAL DIAGNOSIS, MEDICAL TREATMENT OR BIOMEDICAL RESEARCH Justification of practices of any type of human imaging using radiation 32. The justification process applied to the practice of any type of human imaging procedure in which radiation is used for purposes other than for medical diagnosis or medical treatment or as part of a program of biomedical research shall include the consideration of- (a) the benefits and detriments of implementing and not implementing the type of human imaging procedure; (b) any legal or ethical issues associated with the introduction of the type of human imaging procedure; (c) the effectiveness and suitability of the type of human the appropriateness of the radiation equipment for the intended use; imaging procedure, including (d) the availability of sufficient resources to conduct the human imaging procedure safely throughout the intended period of the practice. Optimisation of protection and safety 33. For the purpose of optimising protection and safety, the licensee and registrant shall- (a) for human imaging using medical radiological equipment which exposes human to radiation without reference to clinical indications, comply 34 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) with the appropriate optimisation requirements for medical exposure with dose constraints used instead of diagnostic reference levels; (b) ensure that, subject to any dose constraints for public exposure, procedures with inspection imaging devices in which radiation is used to expose persons- (i) for the purpose of the detection of concealed weapons, contraband or other objects on or within the body are considered to give rise to public exposure and shall apply the requirements specified under these Regulations; (ii) person who undergo procedures with such inspections devices are informed of the possibility of requesting the use of an alternative inspection technique that does not use ionising radiation; (iii) for the detection of concealed objects on or within the body conforms to applicable laws as well guidelines issued by the Commission. PART VII PLANNED EXPOSURE SITUATIONS Requirement for planned exposure situation 34.-(1) establish requirements for planned exposure situations which include the following practices: The Commission shall (a) production, supply, provision and transport of radiation sources and devices that contain radioactive materials and of consumer products; (b) production and supply of devices that generate radiation; (c) generation of nuclear power, including any activities within the nuclear fuel cycle that 35 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) involve exposure to radiation; (d) use of radiation or radioactive material for medical, industrial, veterinary, agricultural, legal or security purposes, including the use of associated equipment, software or devices where such use could affect exposure to radiation; (e) use of radiation sources for education, training or research, including any activities relating to such use that involve exposure to radiation; (f) mining and processing of raw materials that involve exposure due to radiation; and (g) any other practice as specified by the Commission. (2) The for planned exposure situations apply to exposure due to sources within practices, as follows: requirements (a) radiation facilities that contain radiation sources that involve exposure to radiation; (b) individual radiation sources within the facility. (3) The relevant requirements for planned exposure situations apply to- these Regulations where (a) exposure due to material in a practice specified the activity in concentration in the material of any radionuclide in the uranium decay chain or the thorium decay chain is greater than 1 Becquerel per gram (Bq/g) or the activity concentration of Potassium (40K) is greater than 10 Bq/g; (b) public exposure due to discharges or due to the management of radioactive waste arising from a practice involving material as specified in these regulation; (c) exposure due to Radon (222Rn) and its progeny in workplaces in which occupational exposure due to other radionuclides in the uranium decay chain or the thorium decay chain is controlled as 36 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) a planned exposure situation; (d) exposure due to Radon and its progeny where the annual average activity concentration of Radon in air in workplaces remains above the reference level established in these Regulations. Emergence exposure 35. The Commission shall establish requirements for emergency exposure situation to activities undertaken in preparedness for and to a nuclear or radiological emergency. in response Existing exposure 36. The Commission shall establish requirements for existing exposure situations applying to- (a) exposure due to contamination of areas by residual radioactive material deriving from- (i) past activities that were never subject to regulatory control or that were subject to regulatory control but not in accordance these requirements the with Regulations; of (ii) a nuclear or radiological emergency, after an emergency has been declared to be ended; (b) exposure due to commodities and construction radionuclides materials, deriving from residual radioactive material; (c) exposure due to natural sources, including- incorporate that (i) (ii) radon gas and its progeny in workplaces other than those workplaces for which exposure due to other radionuclides in the uranium decay chain or the thorium decay chain is controlled as a planned exposure situation, in dwellings and in other buildings with high occupancy factors for members of the public; radionuclides of natural origin, regardless 37 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) activity of commodities, construction materials radioactive material in the environment; in amendments, residual and concentration, soil (iii) materials, other than those stated in these Regulation in which the activity concentration of radionuclide in either the uranium decay chain or the thorium decay chain exceeds 1 Bq/g and the activity concentration of Potassium-40 (40K) does not exceed 10 Bq/g. Exclusion from requirements of these Regulations 37. The following exposures are excluded from the requirements of these Regulations: (a) exposure to the natural level of radiation, such as radionuclides contained in the human body and cosmic radiation prevailing at ground level; (b) exposure of members of the public or workers other than air or space crew to cosmic radiation in flight or in space, lightning and earth magnetic field; (c) above ground exposure to radionuclides present in the undisturbed earth's crust; (d) exposures from natural non ionising radiation in the body; and (e) the Commission may determine any other essentially that are radiation unamenable to control. sources (a) Occupational Exposure General responsibiliti es 38.-(1) The licensee and registrant shall ensure that protection and safety is optimised and that the dose limits or reference levels for occupational exposure are not exceeded. (2) The licensee and registrant shall ensure, for 38 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) workers who are engaged in activities in which they are or could be subject to occupational exposure, that- (a) relevant dose limits or reference levels for occupational exposure specified in Second and Eighth Schedules to these Regulations are not exceeded; (b) protection and safety is optimised in accordance with these Regulations; (c) decisions with regard to measures for protection and safety are recorded and made available to relevant parties, through their representatives where appropriate; (d) policies, and procedures organisational arrangements for occupational protection and safety are established with priority given to design and technical measures for controlling occupational exposure; (e) suitable and adequate facilities, equipment and services for protection and safety are provided, the type and extent of which are commensurate with the expected likelihood and magnitude of the occupational exposure; (f) necessary workers’, health surveillance and health services for workers are provided; (g) appropriate monitoring equipment and personal and protective arrangements are made for their proper use, calibration, testing and maintenance; equipment provided are (h) adequate records are maintained in accordance with the requirements of these Regulations; and (i) necessary conditions for promoting a safety culture are provided. (3) A licensee and registrant shall- (a) involve workers, through their representatives where appropriate, in optimisation of protection and safety; 39 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (b) establish and use, as appropriate, dose constraints as part of optimisation of protection and safety; (c) ensure that workers are informed that protection and safety is an integral part of a general occupational health and safety program in which they and responsibilities for their own protection and the protection of others against radiation exposure and for the safety of sources; obligations specific have (d) record any report received from a worker that identifies any circumstances that could affect safety and take appropriate remedial actions. security conditions and Classification of areas 39.-(1) A licensee and registrant shall designate as a controlled area any area in which specific measures for protection and safety are required for- (a) controlling exposures or preventing the spread of contamination in normal operations; (b) preventing or likelihood and magnitude anticipated in exposures of operational occurrences and accident conditions. limiting the (2) A registrant and licensee shall- (a) determine the boundaries of controlled area on the basis of the likelihood, magnitude of expected exposures, the type and extent of the procedures required for protection and safety; (b) delineate controlled areas by physical means or, where this is not reasonably practicable, by some other suitable means; (c) where a source is only intermittently brought into operation or energised or is moved from to place, delineate an appropriate place controlled area by means that are appropriate under the prevailing circumstances and specify 40 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) exposure times; (d) display appropriate radiation warning symbol as prescribed in Fifth Schedule to these Regulation, and display signs and instructions at access points to and at appropriate locations within controlled areas; (e) establish measures for occupational protection and safety, including, as appropriate, physical measures to control the spread of contamination and institutional local rules and procedures for controlled areas; (f) restrict access to controlled areas by means of administrative procedures, such as the use of work permits, and by physical barriers, which could include locks or interlocks, the degree of restriction being commensurate with the likelihood and magnitude of exposures; (g) provide, as appropriate, at entrances to controlled areas- (i) personal protective equipment; (ii) equipment for individual monitoring and workplace monitoring; (iii) suitable storage for personal clothing; (h) provide, as appropriate, at exits from controlled areas: (ii) equipment (i) equipment monitoring for contamination of skin and clothing; monitoring for for contamination of any objects or material being removed from the controlled area; for (iii) washing or showering facilities and other personal decontamination facilities; (iv) suitable storage for contaminated personal protective equipment; (i) periodically review conditions to assess whether there is any need to modify the measures for 41 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) protection and safety or the boundaries of controlled areas; (j) provide appropriate information, instructions and training for persons working in controlled areas; (k) designate as a supervised area any area which is not designated as controlled area, where occupational exposure conditions need to be kept under surveillance even though specific protection measures and safety provisions are not normally needed. (3) A licensee and registrant taking into account the likelihood and magnitude of exposures or nature, contamination in the supervised areas, shall- (a) delineate the supervised areas, by appropriate means; (b) display approved signs, as appropriate, at access points to supervised areas; (c) periodically review conditions to assess whether there is any need for further measures for protection and safety or any need for changes to the boundaries of supervised areas. (4) A licensee and registrant shall designate such area in which specific protective measures or safety and security provisions could be required for preventing or limiting unauthorised person to gain access to energised antenna or facing it. (5) A registrant and licensee of telecommunication infrastructure shall ensure that the installed antennas are located and positioned such that no habitable structures are within a zone of 50 meters directly facing the antennas. Occupational exposure assessment and records 40.-(1) A licensee and registrant shall be responsible for making arrangements for the assessment of the occupational exposure of workers, on the basis of individual dose monitoring where appropriate, and shall 42 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) ensure that arrangements are made with appropriate or approved dosimetry service providers that operate under a quality management system. (2) For a worker who works in a controlled and supervised area, individual monitoring shall be undertaken. (3) A registrant or licensee shall ensure that workers who could be subject to exposure due to contamination are identified, including workers who use respiratory protective equipment. (4) A licensee and registrant shall arrange for appropriate monitoring to demonstrate the effectiveness of the measures for protection and safety and to assess intakes of radionuclides and the annual effective doses. the extent necessary to (5) The nature, frequency and precision of individual monitoring determined with shall consideration of the magnitude and possible fluctuations of expose levels and the likelihood and magnitude of potential exposures. be (6) A registrant and licensee shall keep records of exposure, which shall be made available to workers and the Commission. (7) The records of occupational exposure for each worker shall be maintained during and after the worker’s working life, at least until the worker attains or would have attained the age of 75 years, and for not less than 30 years after cessation of the work in which the worker was subject to occupational exposure. (8) The records of occupationally exposed workers that are recorded in a server and the server itself shall be available on site within the United Republic of Tanzania. (9) A licensee and registrant shall maintain confidentiality of the records. Institutional rules, procedures 41.-(1) The licensee and registrant shall minimise the need to rely on administrative controls and personal 43 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) and personal protective equipment protective equipment for protection and safety by providing well engineered design controls and satisfactory working conditions, in accordance with the following hierarchy: (a) engineered controls; (b) administrative controls; (c) personal protective equipment. (2) The licensee and registrant shall, in consultation with workers, through their representatives, in a language appropriate to the audience addressed- (a) establish in writing institutional rules and procedures that are necessary for protection and safety for workers and other persons; (b) include in the institutional rules and procedures any relevant investigation level or authorised level, and the procedures to be followed in the event that any such level is exceeded; (c) make the institutional rules and procedures and the measures for protection and safety known to those workers to whom they apply and to other persons who may be affected by them; (d) ensure that any work in which workers are or could be subject to occupational exposure is adequately supervised and take all reasonable steps to ensure that the rules, procedures, measures for protection and safety provisions are observed. (3) A registrant and licensee shall provide to female workers who are liable to enter controlled areas or supervised areas appropriate information on- (a) the risk to the embryo or fetus due to exposure of a pregnant woman; (b) the importance for a female worker of notifying her employer as soon as possible if she suspects that she is pregnant or if she is breast-feeding; (c) the risk of health effects for a breast-fed infant due to ingestion of radioactive substances. 44 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (4) A registrant and licensee shall ensure that- (a) workers are provided with suitable and adequate personal protective equipment that meets relevant standards or specifications, including as appropriate: (i) protective clothing; (ii) respiratory protective equipment; (iii) protective aprons, gloves, goggles, and organ shields; (b) where appropriate, workers receive adequate instruction in the proper use of protective equipment, including testing for good fit; (c) tasks requiring the use of certain personal protective equipment are assigned only to workers who on the medical advice shall be given personal protective equipment; (d) all personal protective equipment are maintained in proper condition and, if appropriate, are tested at regular intervals; (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 taken or the inconvenience, and of any non-radiological risks that might be associated with using personal protective equipment while performing the task. Radiation monitoring of workplace 42.-(1) The licensee and registrant shall establish, maintain and keep under review a program for the monitoring at the workplace under the supervision of a radiation safety officer commensurate with the graded approach. (2) The program for monitoring shall specify- (a) type, place and frequency of monitoring of workplaces; (b) evaluation of the radiological conditions in all 45 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) workplaces; (c) assessment of the exposure of workers in controlled and supervised areas; (d) review of the classification of controlled and supervised areas; (e) the quantities to be measured including energy absorption rate dose rate, activity concentration in air and surface contamination, expected fluctuations, likelihood and magnitude of exposures in anticipated operational occurrences and accident conditions; (f) the most appropriate measurement methods and procedures; and (g) investigation levels and the actions to be taken if they are exceeded. (3) The licensee and registrant shall maintain records of the findings of the workplace monitoring program and make available to workers. Workers ’ health surveilla nce Informa tion Conditi ons of service 43. A licensee and shall make arrangements for appropriate health surveillance based on the general principles of occupational health to assess the initial fitness and continuing fitness of workers for their intended tasks. registrant 44. A licensee and registrant shall provide all workers with adequate information on health risks due to exposure in normal operation, anticipated operational occurrences and accident conditions. 45.-(1) The conditions of service of workers shall be independent of whether they are or could be subject to occupational exposure. (2) For the purpose of subregulation (1), special compensatory arrangements or preferential consideration with respect to salary, special insurance coverage, working 46 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) hours, length of vacation, additional holidays or retirement benefits shall not be granted or used as substitutes for measures for protection and safety in accordance with the requirements of these Regulations. licensee and registrant shall make all (3) A reasonable efforts to provide workers with suitable alternative employment in circumstances where it has been determined, that workers, for health reasons, may no longer continue in employment in which they are or could be subject to occupational exposure. (4) A person under the age of 16 years shall not be subjected to occupational exposure and person under the age of 18 years shall not be allowed to work in a controlled area unless supervised and then only for the purpose of the training. (b) Medical Exposure 46.-(1) A licensee and registrant shall ensure that a patient undergoes a medical exposure where- (a) it is a radiological procedure that has been requested by a referring medical practitioner and information on the clinical context that has been provided, or it is part of an approved health screening program; (b) the medical exposure has been justified by means of consultation between the radiological medical practitioner and the referring medical practitioner, as appropriate, or it is part of an approved health screening program; (c) a radiological medical practitioner has assumed responsibility for protection and safety in the planning and delivery of the medical exposure; and General responsibiliti es (d) the patient or the patient’s legal authorised as representative informed, been has 47 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) appropriate, of therapeutic procedure and radiation risks. benefits the expected diagnostic or radiological the of (2) A licensee and registrant shall ensure that- (a) an individual shall not incurs a medical exposure as part of a program of biomedical research unless the exposure has has followed relevant ethical institutional radiological medical practitioner have assumed responsibility; approved a conduct and by (b) the requirements are met for the optimisation of protection and safety for persons subject to exposure as part of a program of biomedical research; (c) an individual shall not incurs a medical exposure as a carer or comforter unless has received, and has indicated an understanding of, relevant information on radiation protection and information on the radiation risks prior to providing care and comfort to an individual undergoing a radiological procedure; (d) the requirements for optimisation of protection and safety for any radiological procedure in which an individual acts as a carer or comforter are complied; (e) the radiological medical practitioner while performing or overseeing radiological procedure has the overall responsibility for protection and safety of patients; the (f) the radiological medical practitioners, medical physicists, radiation technologists and other health professionals with specific duties in relation to protection and safety for patients in a given radiological procedure are specialised in the appropriate area; (g) for therapeutic radiological procedures; 48 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) dosimetry, assurance, calibration, acceptance and commissioning of medical radiological equipment are conducted by a medical physicist; quality interventional (h) for diagnostic guided radiological procedures and procedures; image calibration, assurance, acceptance and commissioning of medical radiological equipment are conducted and documented by medical physicist. dosimetry, quality Justification of medical exposure 47.-(1) Medical exposures shall be justified by weighing the diagnostic or therapeutic benefits that are expected to yield against the radiation detriment that they might cause, with account taken of the benefits and the risks of available alternative techniques that do not involve medical exposure. (2) The justification of medical exposure for an individual patient shall be carried out by means of consultation between the radiological medical practitioner and the referring medical practitioner with account taken for patients who are pregnant or breast-feeding or paediatric of- (a) the appropriateness of the radiological procedure equest; (b) the urgency of the radiological procedure; (c) the characteristics of the medical exposure; (d) the characteristics of the individual patient; (e) relevant information from the patient’s previous radiological procedures. (3) Relevant national or approved international referral guidelines shall be taken into account for the justification of the medical exposure of an individual patient in a radiological procedure. (4) A radiological procedure on an asymptomatic individual that is intended to be performed for the early 49 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Optimisation of protection for medical exposures detection of disease, but not as part of an approved health screening program, shall require specific justification for that individual by the radiological medical practitioner and the referring medical practitioner, in accordance with the guidelines of relevant professional body or the health authority. (5) For the purpose of subregulation (4), the individual shall be informed in advance of the expected benefits, risks and limitations of the radiological procedure. (6) The exposure of volunteers as part of a program of biomedical research is deemed to be justified where it is subject to approval by an institutional body that has been assigned functions similar to those of an ethics committee by the relevant authority, subject to dose constraints specified under these Regulations. 48.-(1) A registrant, licensee and radiological medical practitioners shall ensure that protection and safety is optimized for each medical exposure. (2) A registrant and licensee shall ensure that design of sources equipment, and its operational aspects are optimized as prescribed in the Third Schedule to these Regulations. (3) A registrant, licensee and suppliers shall ensure that medical radiological exposure equipment and software conforms to the national standards. (4) For diagnostic radiological procedures and image guided interventional procedures, registrant and licensee shall ensure that the following are used- (a) appropriate medical radiological equipment and software and, for nuclear medicine, appropriate radiopharmaceuticals; (b) appropriate techniques and parameters to deliver a medical exposure of the patient that is the minimum necessary the clinical purpose of the radiological procedure. to fulfill 50 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (5) For therapeutic radiological procedures, the radiological medical practitioner, in cooperation with the medical physicist and the medical radiation technologist, shall ensure that for each patient the exposure of volumes other than the planned target volume is kept as low as reasonably achievable. (6) For therapeutic radiological procedures in which radiopharmaceuticals are administered, the radiological medical practitioner, in cooperation with the medical physicist and the medical radiation technologist, and radiopharmacist or radiochemistry ensures that each patient is administered with the appropriate radiopharmaceutical so that the radioactivity is primarily localized in the organ(s) of interest, while the radioactivity in the rest of the body is kept as low as reasonably achievable. (6) Licensees shall ensure that the particular aspects of medical exposures are considered in the optimisation process for- (a) paediatric patients subject to medical exposure; (b) individuals subject to medical exposure as part of a health screening program; (c) volunteers subject to medical exposure as part of a program of biomedical research; (d) relatively high doses to the patient; (e) exposure of the embryo or fetus, in particular for radiological procedures in which the abdomen or pelvis of the pregnant female patient is exposed to the useful radiation beam or could otherwise receive a significant dose; and (f) exposure of a breast-fed infant as a result of a female patient having undergone a radiological procedure with radiopharmaceuticals. Calibration 49. The licensee and registrant shall ensure that- (a) all sources giving rise to medical exposure are calibrated; 51 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (b) calibrations are carried out at the time of commissioning a unit prior to clinical use, after any maintenance procedure that could affect the dosimetry and at intervals approved by the Commission; (c) calibrations of radiotherapy units are subject to independent verification prior to clinical use; (d) calibration of all dosimeters used for dosimetry of patients and for the calibration of sources is traceable to a standards dosimetry laboratory. Dosimetry of patients 50. A licensee and registrant shall ensure that- (a) dosimetry of patients is performed by a medical physicist and documented; (b) typical doses to patients undergoing diagnostic and image guided interventional procedures; (c) absorbed doses to the planned target volume for each patient treated with external beam therapy or brachytherapy are as prescribed by the radiological medical practitioner; (d) typical absorbed doses to patients treated with unsealed sources. 51. A registrant andlicensees shall ensure that- (a) assessments on the basis of the measurements required in these Regulations are made at approved intervals; (b) a review is conducted to determine whether the optimisation of protection and safety for patients is in accordance with the relevant diagnostic reference the Fourth levels prescribed Schedule to these Regulations. in Diagnostic reference levels Quality assurance for medical exposure 52.-(1) A registrant and licensee shall establish a comprehensive quality assurance program that ensures optimisation of medical exposures. 52 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (2) The quality assurance program for medical exposures include: (a) major maintenance procedure that may affect protection and safety of patients; (b) installation of new software or modification of existing software; (c) verification of the appropriate physical and clinical factors used in radiological procedures; (d) maintaining records of relevant procedures and results; and (e) periodic checks of the calibration and conditions of operation of dosimetry equipment and monitoring equipment. (3) A registrant and licensees shall ensure that quality assurance program is audited regular, and that frequency is in accordance with the complexity of the radiological procedures and the associated risks. 53.-(1) A registrant and licensee shall ensure that relevant dose constraints are used in the optimisation of protection and safety in radiological procedure in which an individual acts as a carer or comforter. (2) A registrant and licensees shall ensure that dose constraints approved by the Commission are used in the optimisation of protection and safety for persons subject to exposure as part of biomedical research program as prescribed in Sixth Schedule to these Regulations. 54.-(1) A licensee and registrant shall ensure that- (a) appropriate radiation protection procedures are in place where a female patient is pregnant or breast-feeding; (b) appropriate warning notices and signs in appropriate languages are placed in waiting rooms and other appropriate places informing female patients for patients, cubicles 53 Dose constraints Pregnant or breast- feeding female patients Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) who are to undergo a radiological procedure to notify the radiological medical personnel in the event that- (i) she is pregnant; (ii) she is breast-feeding; (c) there are procedures in place for- (i) ascertaining the pregnancy status of a female patient of reproductive capacity before the performance of any radiological procedure that could result in a significant dose to the embryo or fetus; and (ii) establishing that a female patient is not currently the breast-feeding performance of any radiological procedure a involving radiopharmaceutical that could result in a significant dose to a breast-fed infant. administration before the of Release of patients after radionucli de therapy 55. A registrant and licensees shall ensure that- (a) there are procedures in place for radiation protection of members of the public before a patient is released after radionuclide therapy; (b) no patient who has undergone a therapeutic radiological procedure is discharged from a medical radiation facility unless it has been established by either a medical physicist or the facility’s radiation protection officer that- (i) (ii) in compliance with the activity of radionuclides in the patient is such that doses that could be received by members of the public from the patient would be these Regulation; the patient or the guardian of the patient is provided with written instructions for keeping doses to persons in contact with or in the vicinity of the patient as low as 54 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Unintend ed and accidental medical exposures Investigat ion of unintende d and accidental medical exposures reasonably achievable and for avoiding the spread of contamination and information on the radiation risks. 56. A registrant and licensee shall ensure that all practicable measures are taken to minimise the likelihood of unintended or accidental medical exposures arising from flaws in design and operational failures of medical radiological equipment, from failures of and errors in software, or as a result of human error. 57.-(1) A registrant and licensee shall promptly investigate any of the following unintended or accidental medical exposure: (a) any medical treatment delivered- (i) to the wrong individual or to the wrong tissue or organ of the patient; (ii) using the wrong radiopharmaceutical; (iii) with an activity, a dose or dose fractionation differing substantially from the values prescribed by the radiological medical practitioner, that could lead to unduly severe secondary effects; (b) any diagnostic radiological procedure or image guided interventional procedure in which the wrong individual or the wrong tissue or organ of the patient is subject to exposure; (c) any exposure for diagnostic purposes that is substantially greater than was intended; (d) any exposure arising from an image guided interventional procedure that is substantially greater than was intended; (e) any inadvertent exposure of the embryo or fetus in the course of performing a radiological procedure; and (f) any failure of medicalradiological equipment, 55 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) failure of software or system failure, error, mishap or other unusual occurrence with the potential for subjecting the patient to a medical exposure that is substantially different from what was intended. (2) With regard to any unintended or accidental medical exposures investigation the registrant and licensee shall- (a) calculate or estimate the doses received and the dose distribution within the patient; (b) indicate the corrective actions required to prevent recurrence of such an unintended or accidental exposure; (c) implement all the corrective actions that are under their own responsibility; (d) produce and keep a written report that states the cause of the unintended or accidental medical exposure and submit it to the Commission; (e) ensure that the appropriate radiological medical practitioner referring medical practitioner and the patient or the patient’s legal authorised representative of the unintended or accidental medical exposure. informs the Radiological reviews 58. A registrant and licensee shall ensure that radiological reviews- (a) are performed periodicall as provided in the guidelines issued by the Commission; and (b) includes an investigation and critical review of the current practical application of the radiation protection principles. Records of medical exposures 59.-(1) A registrant and licensee shall maintain records of medical exposure for a period as specified by the Commission. (2) The record for medical exposure under this 56 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) regulation shall include: (a) records of calibration, dosimetry and quality assurance; (b) records of calibrations reports; (c) records of dosimetry of patients; (d) records of assessments and reviews made with regard to diagnostic reference levels; (e) records associated with the quality assurance program; (f) information for necessary retrospective assessment of doses, including the number of exposures and the duration of fluoroscopic radiological procedures and number of images acquired; (g) for nuclear medicine, the types radiopharmaceutical administered and activity; of their (h) for external beam radiation therapy or brachytherapy, a description of the planning target volume, the absorbed dose to the Centre of the planning target volume, and the maximum and minimum absorbed doses delivered to the planning target volume, or equivalent alternative information on absorbed doses to the planning target volume, and the absorbed doses to relevant tissues or organs as determined by the radiological medical practitioner; (i) for external beam radiation therapy, the dose fractionation and the overall treatment time; (j) exposure records for volunteers subject to medical exposure as part of a program of biomedical research; and (k) reports on investigations of unintended and accidental medical exposures as required in these Regulations. 57 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (c) Public Exposure General responsib ilities 60.-(1) A registrant, licensee and supplier in applying the principle of optimisation of protection and safety and decommissioning of a source or for closure and the post- closure period for waste disposal facilities, shall take into account- operation planning, design, the in (a) possible changes in any conditions that could affect exposure of members of the public, such as changes in the characteristics and use of the source, changes in environmental dispersion conditions, changes in exposure pathways or changes in values of parameters used for the determination of the representative person; (b) good practice in the operation of similar sources or the conduct of similar practices; (c) possible buildup and accumulation the environment of radioactive substances from discharges during the lifetime of the source; and in (d) uncertainties in the assessment of doses. (2) A licensee and registrant for radiation sources under their responsibility, shall establish, implement and maintain- organisational in (a) policies, procedures and arrangements for protection and safety relation to public exposure; (b) measures for ensuring: (i) optimisation of protection and safety; and (ii) limitation of exposure of members of the public from such sources, in order that the total exposure is not higher than the dose limits for members of the public as specified in the Second Schedule of these Regulations; (c) measures for ensuring the safety of such 58 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) sources; (d) provision for suitable and adequate resources including facilities, equipment and services for the protection and safety of members of the public, commensurate with the likelihood and magnitude of the exposures; (e) programs for appropriate training of personnel having functions relevant to the protection and safety of the public, and periodical training as required, to ensure the necessary level of competence; (f) provision for appropriate monitoring equipment, monitoring programs and methods for assessing public exposure; (g) emergency preparedness and response plan in accordance with the nature and magnitude of the radiation risks associated with the sources; and (h) adequate records of monitoring programs. (3) The Commission shall- (a) establish or approve dose constraints of risks to be used in the optimisation of protection and safety for members of the public; (b) enforce compliance with the dose limits and reference levels specified in Second and Eighth Schedules these Regulations for public exposure; to (c) provide information on levels of radon indoors and the associated health risks; and (d) implement an action plan for controlling public exposure due to radon indoors. (4) Before authorisation of a new or modified practice, a registrant and licensee shall submit the safety assessments and other design related documents for exposure and potential exposure of members of the public. (5) The reference levels and conditions specified in these Regulations shall- 59 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (a) be used by registrant and licensee as the criteria for demonstration of compliance after the commencement of operation of a source; (b) correspond to doses below the dose limits with account taken of the results of optimisation of protection and safety; (c) reflect good practice in the operation of similar facilities or activities; (d) allow for operational flexibility; (e) take into account the results of the prospective assessment radiological environmental impacts that is undertaken in accordance with requirements of these Regulations. for Exposure from multiple sources Control of visitors 61. A licensee and registrant shall ensure that public exposed to multiple sources, total dose rate shall not exceed 1mSv per year. 62. For the purpose of controlling visitors, registrant and licensee shall- the relevant (a) apply requirements of these Regulations in respect of public exposure for visitors to a controlled area or a supervised area; (b) visitors are accompanied in any controlled area by a person who knows the measures for protection and safety for the controlled area; (c) provide adequate information and instructions to they enter a controlled or visitors before supervised area; and (d) adequate control is maintained over the entry of visitors to a controlled or supervised area. Sources of external irradiation 63. For sources that may give rise to external exposure to the members of the public, a registrant and licensee shall ensure that- (a) the floor plans, arrangements of equipment for 60 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) new installations significant all modifications installations utilizing such sources are subject to review and approval under these Regulations; and the existing to (b) shielding, access control and other measures for as safety, protection are provided appropriate for restricting public exposure. and Control of discharge and contaminatio n of radioactive materials accessible to members of public 64. For the purpose of control of discharge of radioactive materials and contamination of areas accessible to the members of the public, a registrant and licensee shall ensure- (a) radioactive materials from authorised practices are not discharged to the environment unless the requirements of these Regulations are complied; for (b) specific provisions confinement are established for the design and operation of a source spread of contamination in areas that are accessible to members of the public; and that may cause the (c) measures for protection and implemented for restricting public exposure. safety are Monitoring of public exposure 65.-(1) For the purpose of monitoring public exposure a registrant and licensee shall- (a) establish and implement monitoring programs to ensure that sources under their responsibility are adequately assessed; (b) maintain appropriate records of the results of the monitoring programs and estimated doses to the public; (c) report to the Commission results of the levels and composition of discharges, dose rates at the site boundary and in premises open to the and public, environmental monitoring 61 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) retrospective assessments made for doses to the representative person at authorised intervals; (d) report promptly to the Commission any levels exceeding the reference levels; (e) report promptly significant concentrations environment; to increase of the Commission any or the dose radionuclides rate in in (f) establish and maintain capability to carry out monitoring in an emergency situation; (g) verify the adequacy of the assumptions made for the assessment of public exposure and radiological environmental impacts; (h) make available upon request the results from public dose assessments. (2) The monitoring programs in this regulation shall include- (a) external exposure from such sources; (b) discharges; (c) radioactivity in the environment; and (d) other parameters for the assessment of public the specified by exposure as may be Commission. Consumer products 66. Providers of consumer products shall ensure that products- (a) are not made available to the public unless the justification of their use by the public has been approved by the Commission; (b) have clear and appropriate information and instructions on- (i) use, maintenance, servicing, repair and correct installation; (ii) the radionuclides and their activities; (iii) dose rates in normal operation and during servicing and repair; 62 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (iv) required or recommended options for recycling or disposal; and (v) safe and secure transport and storage. (d) Existing Exposures Management of existing exposure situations 67.-(1) A registrant and licensee shall develop and implement a radiation protection program to manage existing exposure situations including remediation of areas contaminated with residual radioactive material. (2) The Commission shall- (a) specify the exposure situations that are included in the scope of existing exposure situations; (b) specify the general principles underlying the reduce strategies developed protection exposure when remedial actions and protective actions have been determined to be justified; (c) assign responsibilities for the establishment and to implementation of protection strategies registrants, licensees and other parties involved in the implementation of remedial actions and protective actions; to (d) provide for the involvement of interested parties in decisions regarding the development and implementation of protection strategies, as appropriate. (3) The Commission shall establish protection strategies for existing exposure situations which include the objectives to be achieved by means of the protection and appropriate reference levels. (4) The Commission shall implement the protection strategy, including: (a) arranging for evaluation of the available remedial actions and protective actions for achieving the objectives; (b) evaluation of the efficiency of the actions 63 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) planned and implemented; (c) ensuring that information is available to subject to exposure on potential health risks. (5) The Commission shall ensure that the protection strategy for the management of existing exposure situations is established and commensurate with the radiation risks associated with the existing exposure situation. (6) The licensee or registrant shall be responsible for remedial or protective actions to ensure that the form, scale and duration of such actions are optimised. Remediation of areas with residual radioactive materials 68.-(1) Licensee or registrant responsible for the planning, implementation and verification of remedial actions shall ensure that- (a) a remedial action plan, supported by a safety assessment, is prepared and is submitted to the Commission; (b) a mechanism for public information is in place the interested parties affected by the and existing exposure situation; (c) a monitoring program is established and implemented; (d) system for maintaining adequate records relating to the existing exposure situation and actions taken for protection and safety is in place; (e) procedures are in place for reporting to the Commission on any abnormal conditions relevant to protection and safety. (2) Licensee or registrant responsible for carrying out the remedial actions shall- (a) ensure that the work, including management of the radioactive waste arising, is conducted in accordance with the remedial action plan; (b) take responsibility for all aspects of protection and safety, including the performance of a safety assessment; 64 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (c) monitor and perform a radiological survey of the area regularly during the remediation work so as to verify levels of contamination as specified by the Commission; (d) perform a radiological survey after completion of remedial actions to demonstrate that the end point conditions, as established in the remedial action plan, have been met; (e) prepare and retain a final remediation report and submit a copy to the Commission. (3) Licensee or registrant responsible for post- remediation control measures shall establish and maintain for as long as required by the Commission, an appropriate program, including any necessary provisions for monitoring and surveillance, to verify the long term effectiveness of the completed remedial actions for areas in which controls are required after remediation has been completed. (4) The Commission shall take responsibility for- (a) review of the safety assessment submitted by the licensee or registrants; (b) approval of the remedial action plan and of any subsequent changes to the remedial action plan, and granting of any necessary authorisation; (c) establishment of criteria and methods for assessing safety; (d) review of work procedures, monitoring programs and records; (e) review and approval of significant changes to procedures or equipment that may have radiological environmental impacts or that may alter the exposure conditions for workers taking remedial actions or for members of the public; (f) where necessary, establishment of regulatory requirements for control measures following remediation. (5) After the remedial actions have been completed, 65 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) the Commission shall- the (a) review, amend as necessary and formalize the type, extent and duration of any post- remediation control measures already identified remedial action plan, with due in consideration of the residual radiation risks; (b) identify the person or organisation responsible for any post-remediation control measures; (c) where necessary, impose specific restrictions for the remediated area to control- (i) access by unauthorised persons; (ii) removal of radioactive material or use of in including its use such material, commodities; (iii) future use of the area, including the use of the the water resources and its use for production of food or feed, and consumption of food from the area; and (d) periodically review conditions in the remediated area and, if appropriate amend or remove any restrictions. (6) For the remediation of areas with residual radioactive material deriving from past activities or from a nuclear or radiological emergency, the Commission shall- (a) identify persons or organisations responsible for the contamination of areas and those responsible for financing the remediation program, and the determination of appropriate arrangements for alternative sources of funding if such persons or organisations are no longer present or are unable to meet their liabilities; (b) designate persons or organisations responsible for planning, implementing and verifying the results of remedial actions; (c) establish any restrictions on the use of or access to the areas concerned before, during and, if 66 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) necessary, after remediation; (d) establish an appropriate system for maintaining, retrieval and amendment of records that cover the nature and the extent of contamination; the decisions made before, during and after remediation; and information on verification of the results of remedial actions, including the results of all monitoring programs after completion of the remedial actions. 69. The Commission shall establish a program for managing, controlling and recording the doses received in an emergency by emergency worker, which shall be implemented by response organisations and employers. Protectio n of emergenc y workers in emergenc y exposure situation PART VIII RADIATION GENERATORS AND RADIOACTIVE SOURCES General responsibiliti es 70. A licensee and registrant with regard to activities related to radiation generators and sources construction, including assembly, and decommissioning or closure of facilities shall- designing, use, maintenance locating, siting, commissioning, (a) take account of national standards; (b) be supported by managerial and organisational features, with the purpose of ensuring protection and safety throughout the lifetime of the facility; (c) observe adequate safety margins in the design, construction and in operations involving the facility including safety warning notices and symbols; (d) take account of relevant developments concerning technical criteria, as well as the 67 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Design of radiation generators and radioactive sources results of any relevant research on protection, safety and feedback of information on lessons learned from experience; and (e) do such other things as may be specified by the Commission. 71.-(1) A licensee and registrant who deals with radiation generators and radioactive sources shall ensure that- (a) the radiation generator or radioactive source and device in which the radiation generator or radioactive source is used are well-designed, manufactured and constructed in a manner that- (i) provides for protection and safety in accordance with the requirements of these Regulations; (ii) meets and engineering, performance functional specifications that conform to standards of national and technical approved International Standards; (iii) meets quality standards commensurate with the significance for protection and systems and components, safety of including software; (iv) provides clear displays and instructions on in a Swahili and operating consoles English language; (b) radiation generators and radioactive sources are tested to demonstrate compliance with the relevant specifications; (c) information is available, in English or Swahili, on the proper installation and use of the radiation generator or radioactive source and its associated radiation risks; and (d) protection provided by shielding and by other protective devices is optimised; 68 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (e) the radioactive source itself and its container are marked with applicable symbols; (f) sealed sources are identifiable and traceable; (g) where radioactive sources are not in use they are stored in an appropriate manner for protection and safety; and (h) where the sealed radioactive sources have become spent or disused, a registrant and licensee shall make arrangement for safe management and control of the spent or disused sources until it has been returned to the country of origin. (2) For the purposes of this regulation “disused source” means a radioactive source that is no longer used, and is not intended to be used, for the practice for which an authorisation has been granted. Supply and acquisition of radioactive sources 72.-(1) A licensee and registrant who supply or distribute radioactive sources shall ensure that those persons to whom the sources are being supplied are authorised to receive the sources. (2) Prior to acquisition of sources a licensee and registrant shall- (a) ensure equipment containing sources conform to applicable national standards and approved international standards; and (b) enter into an agreement that the supplier shall take back the source when no longer in use and submit the to agreement. the Commission copy of (3) A registrant and licensee supplying sources or devices incorporating radioactive sources shall provide the recipient with all relevant technical information to permit their safe management. Storage of radioactive 73.-(1) A registrant and licensee shall ensure storage 69 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) sources of radioactive materials, interim storage of sources on entry points or on transit are authorised by the Commission. (2) A registrant and licensee shall ensure packages of radioactive materials are stored in separate transit area for a short time as practicable and far from other hazardous materials. (3) A registrant and licensees shall ensure that the following requirements with regards to storage of radiation sources are met: (a) where the sources are not in use shall be stored in a place assigned for the purpose of storage only; (b) the storage shall be adequately shielded such that at the outside surface of its walls or containment the radiation dose shall not exceed 0.5 µSv per hour, and shall be chosen so as to minimise risks from fire or flood; (c) the place of storage shall be inspected regularly and checked for possible contamination; (d) the place of storage shall be sited and designed so as to ensure that both during storage and in the course of transfer of radiation sources to and from the store, the sources do not give excessive exposure to any person; (e) if the place of storage is to contain either sealed or unsealed radiation sources that are liable to release a radioactive gas, the store shall be continuously vented to the open air; (f) all radiation sources stored shall be clearly labeled, giving information on their activity and physical form; (g) the containers for beta emitting radionuclides shall have adequate thickness to reduce the primary radiation to a safe level: Provided that, bremsstrahlung radiation that may arise from high intensity sources shall be 70 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) provided with additional shielding; (h) gamma and neutron sources shall be stored in such a way as to limit the radiation exposure from the other sources when any one source is being handled; (i) appropriate equipment shall be provided for storing unsealed radiation sources to prevent external irradiation and internal contamination hazards; (j) records shall be kept of all stored radiation inventories shall be updated sources and periodically; (k) records of the stored sources shall give clear information on the type of source activity, times of removal and return, and the name of the person responsible for the source during its absence from the store; and (l) bottles containing radioactive materials in liquid forms shall be placed in non-fragile vessels large enough to hold the entire contents of the bottles in case of breakage. Accountabilit y on radioactive sources 74.-(1) A licensee and registrant shall maintain an accountability system that includes: (a) records of the location and description of each source; (b) records of the activity and form of each radioactive substance; (c) arrangements of sources to be secured by ensuring that- (i) control of a source is not relinquished without compliance with all relevant requirements specified in the license and without immediate communication to the Commission of information regarding any lost, stolen or missing decontrolled, 71 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) source; (ii) a source is not transferred unless the receiver possesses a valid authorisation; (iii) records are maintained of source inventory, including records of receipt, transfer and disposal of sources; and (d) a periodic inventory of sources is conducted at intervals specified in the license to confirm that they are in their assigned locations and are secure. (2) A licensee and registrant shall maintain an accountability system of nuclear materials as prescribed in the to nuclear non-proliferation safeguards. regulations relating Export of category 1 or 2 radioactive sources 75.-(1) A licensee intending to export category 1 or 2 radioactive sources shall apply to the Commission for an export authorisation. (2) The application for authorisation to export category 1 or 2 radioactive sources shall include a copy of the recipient authorisation to receive and possess the sources to be exported that includes at least the following information: (a) name of the recipient; (b) recipient location and legal address or principal place of business; (c) relevant radionuclides and radioactivity; (d) uses of the source; (e) recipient authorisation expiration date; (f) copies of relevant parts of any contractual agreements to re-import the source; and (g) justification or explanation of any need to use the exceptional circumstances. (3) After receiving authorisation to export the source, licensee shall ensure that- (a) the export of the source is conducted in 72 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) GN. No. 368 of 2011 compliance with the requirements as prescribed in the Atomic Energy (Packaging and Transport of Radioactive Materials) Regulations, 2011; (b) the importing state is notified in advance of each shipment with the following information in writing: (i) the estimated date of export; (ii) exporting facility; (iii) recipient; (iv) radionuclides and radioactivity; (v) aggregate activity level; (vi) the number of radioactive sources and, if available, their unique identifiers; and (c) for category 1 radioactive sources only, the be notification accompanied by a copy of the importing states consent to import the sources. described should above Import of category 1 or 2 radioactive sources 76.-(1) A licensee intending to import category 1 or 2 radioactive sources shall apply to the Commission for an import authorisation. (2) The application for authorisation to import sources shall include the following information: (a) name of the exporter; (b) exporter location and legal address or principal place of business; (c) name of the recipient; (d) recipient location and legal address or principal place of business; (e) relevant radionuclides and radioactivity; (f) uses of the sources; (g) details of the arrangements the safe management of the source, including financial provisions where appropriate, once they have become disused, including copies of any contractual agreements; for 73 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) GN. No. 368 of 2011 General responsibiliti es (h) justification or explanation of any need to use the exceptional circumstances. (3) After receiving authorisation to import the sources, licensees shall ensure that the importation is in compliance with the requirements as prescribed in the Packaging and Transport of Radioactive Materials Regulations. PART IX RADIOACTIVE WASTE MANAGEMENT 77. A licensee and registrant shall ensure that generation, storage, development, operation, management of radioactive waste and decommissioning of radioactive waste facilities are managed as follows: (a) any radioactive waste generated is kept to the minimum practicable in terms of both activity and volume; and disposal half-life, (b) ensure that there is separate processing of radioactive waste of different types, for their storage activity concentration, volume, physical and chemical properties, taking into account the available options for storage and disposal of radioactive waste; (c) ensure the predisposal that activities management of and the disposal of radioactive waste are conducted in accordance with the authorisation; for for (d) maintain a waste inventory of all radioactive waste that is generated, stored, transferred or disposed of, including particulars on Quantity, radionuclide, activity, form and characteristics of waste under their responsibilities; (e) develop for radioactive waste management and shall include implement strategy and a 74 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) appropriate evidence that protection and safety is optimised. Radioactive waste management facility or activities 78.-(1) A licensee and registrant shall be responsible the predisposal radioactive waste the safety of for management facility or activities. (2) Any person, organisation, licensee or registrant shall submit to the Commission for approval, a safety case which include the following: (a) all safety aspects of the site, the design of the facility, and the managerial and regulatory controls; (b) the level of protection provided and assurance that safety requirements will be met; (c) an integrated approach to safety, nuclear security and if applicable nuclear safeguards in the management and disposal of radioactive waste, spent nuclear fuel and disused sealed radiation sources; (d) the level and complexity of safety and security measures which commensurate with the degree of hazard posed by the radioactive waste, spent nuclear fuel or disused sealed radiation sources; (e) management systems to provide for assurance of quality; and (f) safety related systems and activities, components throughout all the steps of the development and operation of a radioactive waste, spent nuclear fuel or disused sealed source management or disposal radiation facility. (3) A licensee and registrant shall take into account the interdependences among all steps in the predisposal management of radioactive waste, spent nuclear fuel and disused sealed radiation sources as well as the impact of the anticipated disposal option. 75 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (4) A licensee or registrant shall determine an authorised destination for all of their radioactive waste, spent nuclear fuel and disused sealed radiation sources generated in consultation with Central Radioactive Waste Management Facility. Radioactive waste generation, characterisati on and control 79.-(1) A licensee and registrant of a radioactive waste management facility shall have a waste management plan approved by the Commission. (2) The waste management plan in subregulation (1) shall aim to- (a) minimise the generation of radioactive waste; (b) manage and control different radioactive waste treatment and to optimise types so as conditioning processes; (c) ensure that radioactive waste or disused sealed radioactive source are characterised at the various steps in its predisposal management; (d) maintain records of all types of radioactive waste generated and treated; and (e) ensure that the final radioactive waste is suitable for disposal. (2) Radioactive waste packages shall be designed and produced so is the appropriately contained both during normal operation and in case of accident. radioactive material that (3) Radioactive waste shall be stored in such a manner that it can easily be inspected, monitored, retrieved and preserved in a condition suitable for its subsequent management. (4) Predisposal radioactive waste management facilities shall- (a) be located and designed so as to ensure safety for the expected operating lifetime under both normal and in case of accident and for their decommissioning; 76 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (b) be constructed in accordance with the design as described in the safety case and approved by the Commission; (c) be verified during commissioning to ensure that and equipment, structures, the components perform as planned; systems (d) be operated in accordance with the conditions prescribed under these Regulations. (5) A licensee and registrant shall develop, in the design stage, an initial plan for the end of operations and decommissioning of the predisposal radioactive waste management facility and shall periodically update it throughout the operational period. (6) The decommissioning of the facility shall be carried out on the basis of the final decommissioning plan, as approved by the Commission and sufficient funds shall be available to carry out shutdown and decommissioning. Control of radioactive waste generation 80. A licensee and registrant shall ensure that- (a) the generation of radioactive waste and its impact to the environment is kept as minimum as possible; and (b) disused sealed radiation source is not dismantled without authorisation. Reuse and recycle 81. A licensee and registrant shall, before declaring radioactive material as radioactive waste, consider whether the radioactive material may be reused or recycled. Discharge of radioactive effluents 82.-(1) A licensee and registrant shall not discharge radioactive effluents into the environment unless- (a) the request for discharge has been approved by the Commission; (b) it is in accordance with the prescriptions set out in the First Schedule of these Regulations; (c) resulting doses are kept as low as reasonably 77 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) achievable. (2) Prior to initiating the discharge of radioactive effluents into the environment a licensees and registrants shall- (a) determine the characteristics, potential points, methods and activity of the materials to be discharged; (b) determine any significant exposure pathway by which discharged radionuclides could deliver exposure; (c) assess the doses likely to be incurred by the to planned environment and public due discharges; and (d) submit the requisite reports as contained in paragraphs (a) to (c) to the Commission for approval. Radioactive waste not qualified for release, discharge or disposal 83. Where radioactive waste is not suitable to be released, discharged or disposed to the environment within one year of its creation or any greater time as the Commission may approve, the licensee and registrant shall- Classification and segregation of radioactive waste (a) submit a proposal and obtain approval from the Commission for disposal of the radioactive waste; and (b) comply with any requirements made by the Commission with regards to further treatment and disposal of the radioactive waste. 84.-(1) A licensee and registrant shall- (a) classify the radioactive waste based on their radiological, physical, chemical and biological properties as prescribed in the Seventh Schedule to these Regulations; and (b) segregate in manner the radioactive waste prescribed in regulations 88 and keep the in a separate segregated radioactive waste 78 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) container. (2) The segregated radioactive waste container shall- (a) be clearly and uniquely marked with the details such as activity, types of radionuclides, half-life, physical and non- radiological hazard; chemical form and Container labelling (b) bear a radiation symbol as prescribed in the Fifth Schedule to these Regulations; (c) be robust; (d) be compatible with the radioactive waste; and (e) be able to be filled and emptied safely throughout in storage the expected period including the provision of adequate shielding as appropriate. 85.-(1) A licensee shall ensure a container that contains radioactive waste bears a durable clearly visible label with the radiation symbol which is legible for the whole period of storage. label (2) The shall provide following the information: (a) nature and date of the radioactive waste generated; (b) commencement date of storage; (c) content of major radionuclides; (d) external surface dose rates; (e) radioactive waste category; (f) biological, chemical or other hazardous material if they exist; (g) name of person responsible for the waste generation; and (h) any information that may be required by the Commission. (3) A registrant and licensee shall, prior to removal of empty container to unrestricted areas- (a) ensure that the container is not contaminated; 79 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) and (b) remove or deface the label or otherwise clearly indicate that the container no longer contains radioactive waste as these Regulations. specified in Location of radioactive waste storage 86. A registrant and licensee shall ensure that radioactive waste- (a) is stored in such a way that protects human health and the environment; (b) is not stored in the vicinity of corrosive, explosive or easily flammable materials; and (c) is not stored in areas that are prone to natural disasters. Interim storage facility 87.-(1) A registrant and licensee shall provide for interim storage facility of radioactive waste or disused sealed radioactive sources prior to its clearance, discharge, transfer or disposal. (2) The interim storage facilities shall- (a) be authorised by the Commission; (b) store radioactive wastes or disused radioactive sources for a maximum period of six months prior to deportation to the country of origin or to the designated radioactive waste management facility; central (c) be properly designed and constructed with at least one physical barrier between the radioactive waste and the other materials in the source; (d) be adequately shielded; (e) prevent deterioration of packages; radioactive waste (f) have ability to handle and retrieve of radioactive waste packages; and conventional (g) have safety and physical 80 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) protection. Packaging of radioactive waste 88. For the purpose of ensuring safe packaging of radioactive waste a registrant and licensee shall ensure that- (a) the materials and production of radioactive waste storage container shall guarantee the integrity of the radioactive waste package throughout its expected period of storage; (b) the types of radioactive waste are stored in outer container with puncture proof inner linings; (c) where radioactive waste may corrode or the container or where disintegrate within storage is likely to be prolonged, a suitable lining shall be used in order to maintain the integrity of the contents throughout its expected period of storage; (d) disused sealed radioactive sources are stored in their immediate shielding within containers to reduce exposure and assist future handling; and (e) internal and external surfaces of all containers are checked for contamination each time before the containers are used or reused. Disposal of radioactive materials 89.-(1) Where any radioactive waste does not qualify for discharge into the environment, or clearance within a reasonable time, the licensee managing the waste shall dispose it in approved disposal facility. (2) A person or organisation shall not dispose radioactive waste in a repository unless the requirements for acceptance of radioactive waste for disposal approved by the Commission are satisfied. (3) The responsibility for verification of compliance of radioactive waste package with the acceptance criteria rests with the disposing organisation. Screening of scrap metals 90.-(1) A person shall screen all scrap metals for 81 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) radioactive contamination before smelting, shipment, export or import. (2) The radioactive contaminated scrap metal shall not be smelted, exported or imported without the approval of the Commission. (3) Employers, licensee or registrant who discovers radioactivity of scrap metal shall immediately inform the Commission for further verification. 91.-(1) A licensee and registrant shall establish a comprehensive quality assurance program that ensures optimisation of medical exposures. (2) Licensee applying for a license relating to the management of radioactive waste shall submit a written quality assurance program which is commensurate with the scale of intended operations to the Commission for approval. Quality assurance (3) The quality assurance program shall be designed to ensure that the facilities and equipment are designed, constructed and operated in accordance with specified requirements for operation, all regulations and conditions in a license are complied with, and the radioactive waste, acceptance packages requirements. produced meet the waste (4) Each licensee shall develop and maintain an accurate documentation system to cover all stages of radioactive waste management from its generation to disposal, and quality assurance program shall provide for controlled approval, receipts, retention, distribution and disposition of all records important for safety in accordance with the Commission’s requirements. (5) A licensee shall maintain adequate safeguard against tempering with and loss of records. (6) The effectiveness of the quality assurance program shall be verified by the Commission or approved independent auditors to ensure that a radioactive waste 82 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) management program meets specific requirements. Physical protection of radioactive wastes 92.-(1) A licensee shall ensure adequate physical protection measures of all radioactive wastes in his possession or under his control to prevent unauthorised access to the radioactive waste. radioactive waste and (2) A licensee shall report to the Commission forthwith after its occurrence becomes known to him, any loss, stolen or missing the circumstances under which such an occurrence took place and within thirty days after such occurrence, the licensee shall make a written report with a description of the radioactive material involved, it’s probable disposition, the circumstance under which the loss occurred, actions that have been taken. (3) A licensee shall- (a) report to the Commission any loss of, stolen or missing radioactive waste within 24 hours after such occurrence; and (b) shall make a written report within a description of the radioactive material involved, its probable disposition, the circumstance under which the loss occurred, actions that have been taken. (4) Each licensee shall immediately report to the Commission any event involving waste possessed by the licensee that may have caused or threaten to cause the release of radioactive materials, inside or outside of a restricted area, where an individual could have received an intake excess of one occupational annual limit on intake as specified by the Commission. Financing 93.-(1) The waste generator shall secure adequate finances of management of radioactive waste. (2) The waste generator dispatching a radioactive waste to the Central Radioactive Waste Management Facility for treatment, conditioning and storage services and 83 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) further disposal may be charged for such service as determined by the Commission. (3) For purposes of regulation, “waste generator” means the operating organisation of a facility or activity that generates waste. this Decommissio ning of facilities and activities 94.-(1 ) The Commission shall- (a) establish safety the for decommissioning, including requirements for management of the resulting radioactive waste, and shall prepare associated guides; requirements (b) take actions to ensure that the Commission’s regulatory requirements are met. (2) The licensee shall plan for decommissioning and shall conduct the decommission actions in compliance with the authorisation for decommissioning and with requirements provided by the Commission. (3) A licensee shall ensure the protection of people and environment are optimised during decommissioning of the radiation facilities. (4) A licensee shall use the graded approach in all aspects of decommissioning in determining the scope and level of detail for any particular facility, consistent with the magnitude of the possible radiation risks arising from the decommissioning. (5) Licensee shall ensure the integrated management system covers all aspects of decommissioning. (6) The integrated management for decommission and enable implementation of decommissioning actions with the prime goal of ensuring that decommissioning is conducted safely. planning system shall the 84 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) PART X REQUIREMENTS FOR EMERGENCY PREPAREDNESS AND RESPONSE Responsibilit ies of registrants and licensees 95.-(1) A licensee and registrant shall prepare an emergency plan for the protection of people and the environment. (2) As part of this emergency plan, the licensee and registrant shall include arrangements for the prompt identification of an emergency, and for determining the appropriate level of the emergency response. (3) In relation the emergency response at the scene by the licensee and registrant, the emergency plan shall include: the arrangements for to (a) provision for individual monitoring and area for medical monitoring and arrangements treatment; (b) arrangements for assessing and mitigating any consequences of an emergency. (4) The licensee and registrant shall be responsible for the implementation of their emergency plan. (5) The licensee and registrant shall, as appropriate- (a) develop, maintain and implement procedures to provide the means for preventing loss of control over the source and for regaining control over the source as necessary; (b) make available equipment, instrumentation and diagnostic aids that may be needed; (c) train and periodically retrain personnel in the procedures to be followed and exercise the procedures. Emergenc y preparedn ess and response 96.-(1) Each licensee responsible for sources, including radioactive waste, for which prompt intervention may be required, shall ensure that the emergency plan defines at the scene responsibilities and takes account of 85 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) off-site appropriate for implementation of the emergency plan. responsibilities response of organisations (2) Such emergency plans shall- (a) characterise the content, features and extent of a potential emergency taking into account the results of any hazard assessment and any lessons learned from operating experience and from accidents that have occurred with sources of a similar type; (b) identify the various operating and other conditions of the source which could lead to the need for intervention; (c) describe the methods and instruments for assessing the accident and its consequences on and off the site; (d) provide for protective actions and mitigation actions, and assignment of responsibilities for initiating and discharging such actions; (e) provide for rapid and continuous assessment of the accident as it proceeds and determining the need for protective actions; (f) allocate relevant intervention; responsibilities authorities for notifying for the initiating and (g) provide procedures, including communication relevant arrangements response authorities as for obtaining assistance from firefighting, medical, police and other relevant authorities; for contacting any (h) provide for in training personnel implementing emergency plans and be rehearsed at suitable intervals based on requirements defined in these Regulation; involved (i) provide for periodic review and updating of the plan. Implemen 97.-(1) The licensee and registrant shall ensure that 86 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) tation of interventi on Protectio n of emergenc y workers in emergenc y exposure situation the protective actions or remedial actions aimed at reducing or averting accidental exposures are only undertaken when they are justified. (2) The form, scale and duration of any justified intervention shall be optimised. (3) A licensees and registrant shall promptly notify the Commission when an accidental situation requiring intervention has arisen or is expected to arise and shall keep the Commission informed of- (a) the current situation and its expected evolution; (b) the measures taken to terminate the accident and to protect workers and members of the public; (c) the exposures that have been incurred and that are expected to be incurred. 98.-(1) The Commission shall establish a program for managing, controlling and recording the doses received in an emergency by emergency worker, which shall be implemented by response organisations and employers. (2) The licensee shall specify in the emergency plan the response organisation in averting the emergence exposure. (3) In an emergency exposure situation, the relevant requirements in planned for occupational exposure exposure situations as provided in these Regulations shall be applied for emergency workers, in accordance with a graded approach. (4) The Licensee shall ensure that no emergency worker is subject to exposure in excess of 50 mSv other than- (a) for the purposes of saving life or preventing serious injury; (b) when undertaking actions to avert a large collective dose; or (c) when undertaking actions to prevent severe deterministic effects and actions to prevent the development of catastrophic conditions that 87 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) could significantly affect people and environment. the (5) In the exceptional circumstances specified in these Regulations, micensee shall make all reasonable efforts to keep doses to emergency workers below the values set out in these Regulations. (6) Licensees shall ensure that emergency workers who undertake actions in which the doses received might exceed 50 mSv do so voluntarily. (7) Licensees shall ensure that emergency workers are clearly and comprehensively informed in advance of the associated health risks, as well as of available measures for protection and safety. (8) Licensee shall ensure that emergency workers are trained in the actions that they may be required to take. (9) Workers undertaking repairs of plant and buildings, activities for radioactive waste management, remedial work for the decontamination of the site and the relevant surrounding areas, shall be subject requirements for occupational exposure specified in these Regulations. to (10) Licensees shall take all reasonable steps to assess and record the doses received in an emergency by emergency workers. (11) Licensee shall provide information of the doses received concerning the associated health risks to the workers involved. (12) Workers who receive doses in an emergency exposure situation shall not normally be precluded from incurring further occupational exposure. (13) Workers undertaking repairs to plant and buildings, activities for radioactive waste management, remedial actions for the decontamination of the site, shall be subject to the relevant requirements for occupational exposure in planned exposure situations specified in these Regulations. 88 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) PART XI GENERAL PROVISIONS Cooperation between licensees, registrants and workers 99.-(1) A licensee, registrant and a worker shall cooperate to the extent necessary for compliance by all responsible parties with these the Regulations. requirements of (2) Where the workers are engaged in work that involves or that could involve a source that is not under the control of the registrant or licensee shall cooperate to the extent necessary for compliance by both parties with the requirements of these Regulations. (3) Cooperation between a registrant, licensee shall include- (a) the development and use of specific restrictions on exposure and other means of ensuring that the measures for protection and safety for workers who are engaged in work that involves or could involve a source that is not under the control of their employer are as good as those for employees of the registrant or licensee; (b) specific assessments of the doses received by workers as specified in these Regulation; (c) a clear allocation and documentation of the responsibilities of the employer and those of the registrant or licensee for protection and safety. (4) As part of the cooperation between parties, a registrant or licensee responsible for the source or for the exposure shall, as appropriate- (a) obtain from the employers, including self- employed individuals, the previous occupational exposure history of workers as specified in these Regulations, necessary any information; other and (b) provide the employer, including any available information information appropriate to 89 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) relevant for compliance with the requirements of these Regulations that the employer requests; and (c) provide both the worker and the employer with the relevant exposure records. Transport of radioactive materials requirements 100. Licensees transporting radioactive sources, radioactive waste or any other radioactive material or nuclear material shall do so in compliance with all applicable domestically or transport requirements of regulations relating to safe transport of radioactive materials. internationally Revocation GN. No. 209 of 2004 279 of 1999 101. The Radioactive Waste Management for the Protection of Human Health and Environment Regulations, 1999 and the Atomic Energy (Protection from Ionising) Regulations, 2004 are hereby revoked. ________________ FIRST SCHEDULE ________________ (Made under regulations 7(1) and (3), 21(1) and 82(1)(b)) EXEMPTION AND CLEARANCE CRITERIA CRITERIA FOR EXEMPTION 1. The generic criteria for exemption are: (a) radiation risks arising from the practice or from a source within the practice are sufficiently low as not to warrant regulatory control of the Commission, with no appreciable likelihood of situations arising that could lead to a failure to meet the general criterion for exemption; or (b) regulatory control of the practice or the source would yield no net benefit, in that no reasonable measures for regulatory control would achieve a worthwhile return in terms of reduction of individual doses or of health risks. 2. A practice or a source within a practice may be exempted without further consideration from some or all of the requirements of these Regulations under the terms of paragraph 1(a) 90 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) of this Schedule provided that under all reasonably foreseeable circumstances the effective dose expected to be incurred by any individual (normally evaluated on the basis of a safety assessment) owing to the exempt practice or the exempt source within the practice is of the order of 10 μSv or less in a year. To take into account low probability scenarios, a different criterion could be used, namely that the effective dose expected to be incurred by any individual for such low probability scenarios does not exceed 1 mSv in a year. 3. Under the criteria set out in paragraph 1 and 2 of this Schedule, the following sources within justified practices are automatically exempted without further consideration from the provisions requirements of these Regulations, including requirements for notification, registration or licensing: (a) material in a moderate amount for which either the total activity of an individual radionuclide present on the premises at any one time or the activity concentration as used in the practice does not exceed the applicable exemption level given in Table 1. (b) material in bulk amount for which the activity concentration of a given radionuclide of artificial origin used in the practice does not exceed the relevant value given in Table 2. (c) radiation generators of a type approved by the Commission, or in the form of an electronic tube, such as a cathode ray tube for the display of visual images, provided that: (i) they do not in normal operating conditions cause an ambient dose equivalent rate or a directional dose equivalent rate, as appropriate, exceeding 1 μSv/h at a distance of 0.1 m from any accessible surface of the equipment; or the maximum energy of the radiation generated is no greater than 5 keV. (ii) 4. For radionuclides of natural origin, exemption of bulk amounts of material is necessarily considered on a case by case using a dose criterion of the order of 1 mSv in a year, commensurate with typical doses due to natural background levels of radiation. 5. Exemption may be granted subject to conditions specified by the Commission, such as conditions relating to the physical or chemical form of the radioactive material, and to its use or the means of its disposal. 6. In particular, such an exemption may be granted for equipment containing radioactive material that is not otherwise automatically exempted without further consideration from some or all of the requirements of these Regulations provided that: (a) the equipment containing radioactive material is of a type approved by the Commission. (b) the radioactive material- (i) is in the form of a sealed source that effectively prevents any contact with the radioactive material and prevents its leakage; or 91 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (ii) is in the form of an unsealed source in a small amount such as sources used for radioimmunoassay. (c) in normal operating conditions, the equipment does not cause an ambient dose equivalent rate or a directional dose equivalent rate, as appropriate, exceeding 1 μSv/h at a distance of 0.1 m from any accessible surface of the equipment. (d) necessary conditions for disposal of the equipment have been specified by the Commission. 7. For exemption of radioactive material containing more than one radionuclide on the basis of the levels given in Tables 1 and 2, the conditions for exemption from some or all of the requirements of these Regulations is that the sum of the individual radionuclide activities or activity concentrations, as appropriate, is less than the derived exemption level for the mixture (Xm), determined as follows: where f(i) is the fraction of activity or activity concentration, as appropriate, of radionuclide i in the mixture; X(i) is the applicable level for radionuclide i as given in Table 1 or Table 2; and n is the number of radionuclides present. 8. Radioactive material arising from authorised discharges is exempted from any requirements for notification, registration or licensing unless otherwise specified by the Commission. 9. The values provided in Tables I and 2 are not intended to be applied to the control of discharges or to the control of residual radioactive material in the environment TABLE I. LEVELS FOR EXEMPTION OF MODERATE AMOUNTS OF MATERIAL WITHOUT FURTHER CONSIDERATION: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES Radionuclides H-3 Activity Concentration (Bq/g) 1 × 106 Activity (Bq) Radionuclides 1 × 109 Sc-45 92 Activity Concentration (Bq/g) 1 × 102 Activity (Bq) 1 × 107 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Be-7 Be-10 C-11 C-14 N-13 Ne-19 O-15 F-18 Na-22 Na-24 Mg-28 Al-26 Si-31 Si-32 P-32 P-33 S-35 Cl-36 Cl-38 Cl-39 Ar-37 Ar-39 Ar-41 K-40 K-42 K-43 K-44 K-45 Ca-41 Ca-45 Ca-47 Sc-43 Sc-44 1 × 103 1 × 104 1 × 101 1 × 104 1 × 102 1 × 102 1 × 102 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 103 1 × 103 1 × 103 1 × 105 1 × 105 1 × 104 1 × 101 1 × 101 1 × 106 1 × 107 1 × 102 1 × 102 1 × 102 1 × 101 1 × 101 1 × 101 1 × 105 1 × 104 1 × 101 1 × 101 1 × 101 1 × 107 Sc-46 1 × 106 Sc-47 1 × 106 Sc-48 1 × 107 Sc-49 1 × 109 Ti-44 1 × 109 Ti-45 1 × 109 V-47 1 × 106 V-48 1 × 106 V-49 1 × 105 Cr-48 1 × 105 Cr-49 1 × 105 Cr-51 1 × 106 Mn-51 1 × 106 Mn-52 1 × 105 Mn-52m 1 × 108 Mn-53 1 × 108 Mn-54 1 × 106 Mn-56 1 × 105 Fe-52 1 × 105 Fe-55 1 × 108 Fe-59 1 × 104 Fe-60 1 × 109 Co-55 1 × 106 Co-56 1 × 106 Co-57 1 × 106 Co-58 1 × 105 Co-58m 1 × 105 Co-60 1 × 107 Co-60m 1 × 107 Co-61 1 × 106 Co-62m 1 × 106 Ni-56 1 × 105 Ni-57 1 × 101 1 × 102 1 × 101 1 × 103 1 × 101 1 × 101 1 × 101 1 × 101 1 × 104 1 × 102 1 × 101 1 × 103 1 × 101 1 × 101 1 × 101 1 × 104 1 × 101 1 × 101 1 × 101 1 × 104 1 × 101 1 × 102 1 × 101 1 × 101 1 × 102 1 × 101 1 × 104 1 × 101 1 × 103 1 × 102 1 × 101 1 × 101 1 × 101 1 × 106 1 × 106 1 × 105 1 × 105 1 × 105 1 × 106 1 × 105 1 × 105 1 × 107 1 × 106 1 × 106 1 × 107 1 × 105 1 × 105 1 × 105 1 × 109 1 × 106 1 × 105 1 × 106 1 × 106 1 × 106 1 × 105 1 × 106 1 × 105 1 × 106 1 × 106 1 × 107 1 × 105 1 × 106 1 × 106 1 × 105 1 × 106 1 × 106 TABLE I. LEVELS FOR EXEMPTION OF MODERATE AMOUNTS OF MATERIAL WITHOUT FURTHER CONSIDERATION: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES (cont.... 93 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Radionuclides Ni-59 Ni-63 Ni-65 Ni-66 Cu-60 Cu-61 Cu-64 Cu-67 Zn-62 Zn-63 Zn-65 Zn-69 Zn-69m Zn-71m Zn-72 Ga-65 Ga-66 Ga-67 Ga-68 Ga-70 Ga-72 Ga-73 Ge-66 Ge-67 Ge-68b Ge-69 Ge-71 Ge-75 Ge-77 Ge-78 As-69 As-70 As-71 Activity Concentration (Bq/g) 1 × 104 1 × 105 1 × 101 1 × 104 1 × 101 1 × 101 1 × 102 1 × 102 1 × 102 1 × 101 1 × 101 1 × 104 1 × 102 1 × 101 1 × 102 1 × 101 1 × 101 1 × 102 1 × 101 1 × 102 1 × 101 1 × 102 1 × 101 1 × 101 1 × 101 1 × 101 1 × 104 1 × 103 1 × 101 1 × 102 1 × 101 1 × 101 1 × 101 Activity (Bq) Radionuclides 1 × 108 As-72 1 × 108 As-73 1 × 106 As-74 1 × 107 As-76 1 × 105 As-77 1 × 106 As-78 1 × 106 Se-70 1 × 106 Se-73 1 × 106 Se-73m 1 × 105 Se-75 1 × 106 Se-79 1 × 106 Se-81 1 × 106 Se-81m 1 × 106 Se-83 1 × 106 Br-74 1 × 105 Br-74m 1 × 105 Br-75 1 × 106 Br-76 1 × 105 Br-77 1 × 106 Br-80 1 × 105 Br-80m 1 × 106 Br-82 1 × 106 Br-83 1 × 105 Br-84 1 × 105 Kr-74 1 × 106 Kr-76 1 × 108 Kr-77 1 × 106 Kr-79 1 × 105 Kr-81 1 × 106 Kr-81m 1 × 105 Kr-83m 1 × 105 Kr-85 1 × 106 Kr-85m 94 Activity Concentration (Bq/g) 1 × 101 1 × 103 1 × 101 1 × 102 1 × 103 1 × 101 1 × 101 1 × 101 1 × 102 1 × 102 1 × 104 1 × 103 1 × 103 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 102 1 × 102 1 × 103 1 × 101 1 × 103 1 × 101 1 × 102 1 × 102 1 × 102 1 × 103 1 × 104 1 × 103 1 × 105 1 × 105 1 × 103 Activity (Bq) 1 × 105 1 × 107 1 × 106 1 × 105 1 × 106 1 × 105 1 × 106 1 × 106 1 × 106 1 × 106 1 × 107 1 × 106 1 × 107 1 × 105 1 × 105 1 × 105 1 × 106 1 × 105 1 × 106 1 × 105 1 × 107 1 × 106 1 × 106 1 × 105 1 × 109 1 × 109 1 × 109 1 × 105 1 × 107 1 × 1010 1 × 1012 1× 104 1 × 1010 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) TABLE I. LEVELS FOR EXEMPTION OF MODERATE AMOUNTS OF MATERIAL WITHOUT FURTHER CONSIDERATION: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES (cont....) Radionuclides Kr-87 Kr-88 Rb-79 Rb-81 Rb-81m Rb-82m Rb-83b Rb-84 Rb-86 Rb-87 Rb-88 Rb-89 Sr-80 Sr-81 Sr-82b Sr-83 Sr-85 Sr-85m Sr-87m Sr-89 Sr-90b Sr-91 Sr-92 Y-86 Y-86m Y-87b Y-88 Y-90 Y-90m Y-91 Activity Concentration (Bq/g) 1 × 102 1 × 102 1 × 101 1 × 101 1 × 103 1 × 101 1 × 102 1 × 101 1 × 102 1 × 103 1 × 102 1 × 102 1 × 103 1 × 101 1 × 101 1 × 101 1 × 102 1 × 102 1 × 102 1 × 103 1 × 102 1 × 101 1 × 101 1 × 101 1 × 102 1 × 101 1 × 101 1 × 103 1 × 101 1 × 103 Activity (Bq) Radionuclides 1 × 109 Y-94 1 × 109 Y-95 1 × 105 Zr-86 1 × 106 Zr-88 1 × 107 Zr-89 Zr-93b 1 × 106 1 × 106 Zr-95 1 × 106 Zr-97b 1 × 105 Nb-88 1 × 107 Nb-89 1 × 105 Nb-89m 1 × 105 Nb-90 1 × 107 Nb-93m 1 × 105 Nb-94 1 × 105 Nb-95 1 × 106 Nb-95m 1 × 106 Nb-96 1 × 107 Nb-97 1 × 106 Nb-98 1 × 106 Mo-90 1 × 104 Mo-93 1 × 105 Mo-93m 1 × 106 Mo-99 1 × 105 Mo-101 1 × 107 1 × 106 1 × 106 1 × 105 1 × 106 1 × 106 Tc-93 Tc-93m Tc-94 Tc-94m Tc-95 Tc-95m 95 Activity Concentration (Bq/g) 1 × 101 1 × 101 1 × 102 1 × 102 1 × 101 1 × 103 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 104 1 × 101 1 × 101 1 × 102 1 × 101 1 × 101 1 × 101 1 × 101 1 × 103 1 × 101 1 × 102 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 Activity (Bq) 1 × 105 1 × 105 1 × 107 1 × 106 1 × 106 1 × 107 1 × 106 1 × 105 1 × 105 1 × 105 1 × 105 1 × 105 1 × 107 1 × 106 1 × 106 1 × 107 1 × 105 1 × 106 1 × 105 1 × 106 1 × 108 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 105 1 × 106 1 × 106 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Y-91m Y-92 Y-93 1 × 102 1 × 102 1 × 102 1 × 106 1 × 105 1 × 105 Tc-96 Tc-96m Tc-97 1 × 101 1 × 103 1 × 103 1 × 106 1 × 107 1 × 108 TABLE I. LEVELS FOR EXEMPTION OF MODERATE AMOUNTS OF MATERIAL WITHOUT FURTHER CONSIDERATION: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES (cont....) Radionuclides Tc-97m Tc-98 Tc-99 Tc-99m Tc-101 Tc-104 Ru-94 Ru-97 Ru-103 Ru-105 Ru-106b Rh-99 Rh-99m Rh-100 Rh-101 Rh-101m Rh-102 Rh-102m Rh-103m Rh-105 Rh-106m Rh-107 Pd-100 Pd-101 Pd-103 Activity Concentration (Bq/g) 1 × 103 1 × 101 1 × 104 1 × 102 1 × 102 1 × 101 1 × 102 1 × 102 1 × 102 1 × 101 1 × 102 1 × 101 1 × 101 1 × 101 1 × 102 1 × 102 1 × 101 1 × 102 1 × 104 1 × 102 1 × 101 1 × 102 1 × 102 1 × 102 1 × 103 Activity (Bq) Radionuclides 1 × 107 Ag-106m 1 × 106 Ag-108m 1 × 107 Ag-110m 1 × 107 Ag-111 1 × 106 Ag-112 1 × 105 Ag-115 1 × 106 Cd-104 1 × 107 Cd-107 1 × 106 Cd-109 1 × 106 Cd-113 1 × 105 Cd-113m 1 × 106 Cd-115 1 × 106 Cd-115m 1 × 106 Cd-117 1 × 107 Cd-117m 1 × 107 1 × 106 1 × 106 1 × 108 1 × 107 1 × 105 1 × 106 1 × 107 1 × 106 1 × 108 In-109 In-110 In-110m In-111 In-112 In-113m In-114 In-114m In-115 In-115m 96 Activity Concentration (Bq/g) 1 × 101 1 × 101 1 × 101 1 × 103 1 × 101 1 × 101 1 × 102 1 × 103 1 × 104 1 × 103 1 × 103 1 × 102 1 × 103 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 102 1 × 102 1 × 102 1 × 103 1 × 102 1 × 103 1 × 102 Activity (Bq) 1 × 106 1 × 106 1 × 106 1 × 106 1 × 105 1 × 105 1 × 107 1 × 107 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 105 1 × 106 1 × 106 1 × 106 1 × 105 1 × 106 1 × 105 1 × 106 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Pd-107 Pd-109 Ag-102 Ag-103 Ag-104 Ag-104m Ag-105 Ag-106 1 × 105 1 × 103 1 × 101 1 × 101 1 × 101 1 × 101 1 × 102 1 × 101 1 × 108 1 × 106 1 × 105 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 In-116m In-117 In-117m In-119m Sn-110 Sn-111 Sn-113 Sn-117m 1 × 101 1 × 101 1 × 102 1 × 102 1 × 102 1 × 102 1 × 103 1 × 102 1 × 105 1 × 106 1 × 106 1 × 105 1 × 107 1 × 106 1 × 107 1 × 106 TABLE I. LEVELS FOR EXEMPTION OF MODERATE AMOUNTS OF MATERIAL WITHOUT FURTHER CONSIDERATION: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES (cont....) Radionuclides Sn-119m Sn-121 Sn-121mb Sn-123 Sn-123m Sn-125 Sn-126b Sn-127 Sn-128 Sb-115 Sb-116 Sb-116m Sb-117 Sb-118m Sb-119 Sb-120 Sb-120m Sb-122 Sb-124 Sb-124m Sb-125 Activity Concentration (Bq/g) 1 × 103 1 × 105 1 × 103 1 × 103 1 × 102 1 × 102 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 102 1 × 101 1 × 103 1 × 102 1 × 101 1 × 102 1 × 101 1 × 102 1 × 102 Activity (Bq) Radionuclides 1 × 107 1 × 107 1 × 107 1 × 106 1 × 106 1 × 105 1 × 105 1 × 106 1 × 106 1 × 106 1 × 106 1 × 105 1 × 107 1 × 106 1 × 107 1 × 106 1 × 106 1 × 104 1 × 106 1 × 106 1 × 106 Te-123m Te-125m Te-127 Te-127m Te-129 Te-129m Te-131 Te-131m Te-132 Te-133 Te-133m Te-134 I-120 I-120m I-121 I-123 I-124 I-125 I-126 I-128 I-129 97 Activity Concentration (Bq/g) 1 × 102 1 × 103 1 × 103 1 × 103 1 × 102 1 × 103 1 × 102 1 × 101 1 × 102 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 102 1 × 102 1 × 101 1 × 103 1 × 102 1 × 102 1 × 102 Activity (Bq) 1 × 107 1 × 107 1 × 106 1 × 107 1 × 106 1 × 106 1 × 105 1 × 106 1 × 107 1 × 105 1 × 105 1 × 106 1 × 105 1 × 105 1 × 106 1 × 107 1 × 106 1 × 106 1 × 106 1 × 105 1 × 105 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Sb-126 Sb-126m Sb-127 Sb-128 Sb-128m Sb-129 Sb-130 Sb-131 Te-116 Te-121 Te-121m Te-123 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 102 1 × 101 1 × 102 1 × 103 I-130 I-131 I-132 I-132m I-133 I-134 I-135 1 × 105 1 × 105 1 × 106 1 × 105 1 × 105 1 × 106 1 × 105 1 × 106 Xe-120 1 × 107 Xe-121 1 × 106 Xe-122b 1 × 106 Xe-123 1 × 106 Xe-125 1 × 101 1 × 102 1 × 101 1 × 102 1 × 101 1 × 101 1 × 101 1 × 102 1 × 102 1 × 102 1 × 102 1 × 103 1 × 106 1 × 106 1 × 105 1 × 106 1 × 106 1 × 105 1 × 106 1 × 109 1 × 109 1 × 109 1 × 109 1 × 109 TABLE I. LEVELS FOR EXEMPTION OF MODERATE AMOUNTS OF MATERIAL WITHOUT FURTHER CONSIDERATION: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES (cont....) Radionuclides Xe-127 Xe-129m Xe-131m Xe-133m Xe-133 Xe-135 Xe-135m Xe-138 Cs-125 Cs-127 Cs-129 Cs-130 Cs-131 Cs-132 Cs-134m Cs-134 Cs-135 Activity Concentration (Bq/g) 1 × 103 1 × 103 1 × 104 1 × 103 1 × 103 1 × 103 1 × 102 1 × 102 1 × 101 1 × 102 1 × 102 1 × 102 1 × 103 1 × 101 1 × 103 1 × 101 1 × 104 Activity (Bq) Radionuclides 1 × 105 La-131 1 × 104 La-132 1 × 104 La-135 1 × 104 La-137 1 × 104 La-138 1 × 1010 La-140 1 × 109 La-141 1 × 109 La-142 1 × 104 La-143 1 × 105 Ce-134 1 × 105 Ce-135 1 × 106 Ce-137 1 × 106 Ce-137m 1 × 105 Ce-139 1 × 105 Ce-141 1 × 104 Ce-143 1 × 107 Ce-144b 98 Activity Concentration (Bq/g) 1 × 101 1 × 101 1 × 103 1 × 103 1 × 101 1 × 101 1 × 102 1 × 101 1 × 102 1 × 103 1 × 101 1 × 103 1 × 103 1 × 102 1 × 102 1 × 102 1 × 102 Activity (Bq) 1 × 106 1 × 106 1 × 107 1 × 107 1 × 106 1 × 105 1 × 105 1 × 105 1 × 105 1 × 107 1 × 106 1 × 107 1 × 106 1 × 106 1 × 107 1 × 106 1 × 105 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Cs-135m Cs-136 Cs-137b Cs-138 Ba-126 Ba-128 Ba-131 Ba-131m Ba-133 Ba-133m Ba-135m Ba-137m Ba-139 Ba-140b Ba-141 Ba-142 1 × 101 1 × 101 1 × 101 1 × 101 1 × 102 1 × 102 1 × 102 1 × 102 1 × 102 1 × 102 1 × 102 1 × 101 1 × 102 1 × 101 1 × 102 1 × 102 1 × 106 Pr-136 1 × 105 Pr-137 1 × 104 Pr-138m 1 × 104 Pr-139 1 × 107 Pr-142 1 × 107 Pr-142m 1 × 106 Pr-143 1 × 107 Pr-144 1 × 106 Pr-145 1 × 106 Pr-147 1 × 106 Nd-136 1 × 106 Nd-138 1 × 105 Nd-139 1 × 105 Nd-139m 1 × 105 Nd-141 1 × 106 Nd-147 1 × 101 1 × 102 1 × 101 1 × 102 1 × 102 1 × 107 1 × 104 1 × 102 1 × 103 1 × 101 1 × 102 1 × 103 1 × 102 1 × 101 1 × 102 1 × 102 1 × 105 1 × 106 1 × 106 1 × 107 1 × 105 1 × 109 1 × 106 1 × 105 1 × 105 1 × 105 1 × 106 1 × 107 1 × 106 1 × 106 1 × 107 1 × 106 TABLE I. LEVELS FOR EXEMPTION OF MODERATE AMOUNTS OF MATERIAL WITHOUT FURTHER CONSIDERATION: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES (cont....) Radionuclides Nd-149 Nd-151 Pm-141 Pm-143 Pm-144 Pm-145 Pm-146 Pm-147 Pm-148 Pm-148m Pm-149 Pm-150 Pm-151 Activity Concentration (Bq/g) 1 × 102 1 × 101 1 × 101 1 × 102 1 × 101 1 × 103 1 × 101 1 × 104 1 × 101 1 × 101 1 × 103 1 × 101 1 × 102 Activity (Bq) Radionuclides 1 × 106 Eu-155 1 × 105 Eu-156 1 × 105 Eu-157 1 × 106 Eu-158 1 × 106 Gd-145 1 × 107 Gd-146b 1 × 106 Gd-147 1 × 107 Gd-148 1 × 105 Gd-149 1 × 106 Gd-151 1 × 106 Gd-152 1 × 105 Gd-153 1 × 106 Gd-159 99 Activity Concentration (Bq/g) 1 × 102 1 × 101 1 × 102 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 102 1 × 102 1 × 101 1 × 102 1 × 103 Activity (Bq) 1 × 107 1 × 106 1 × 106 1 × 105 1 × 105 1 × 106 1 × 106 1 × 104 1 × 106 1 × 107 1 × 104 1 × 107 1 × 106 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Sm-141 Sm-141m Sm-142 Sm-145 Sm-146 Sm-147 Sm-151 Sm-153 Sm-155 Sm-156 Eu-145 Eu-146 Eu-147 Eu-148 Eu-149 Eu-150 Eu-150m Eu-152 Eu-152m Eu-154 1 × 101 1 × 101 1 × 102 1 × 102 1 × 101 1 × 101 1 × 104 1 × 102 1 × 102 1 × 102 1 × 101 1 × 101 1 × 102 1 × 101 1 × 102 1 × 101 1 × 103 1 × 101 1 × 102 1 × 101 1 × 106 1 × 105 1 × 106 1 × 107 1 × 107 1 × 105 1 × 104 1 × 108 1 × 106 1 × 106 Tb-147 Tb-149 Tb-150 Tb-151 Tb-153 Tb-154 Tb-155 Tb-156 Tb-156m (24.4 h) Tb‑156mʹ (5 h) 1 × 106 Tb-157 1 × 106 Tb-158 1 × 106 Tb-160 1 × 106 Tb-161 1 × 107 Dy-155 1 × 106 Dy-157 1 × 106 Dy-159 1 × 106 Dy-165 1 × 106 Dy-166 1 × 106 Ho-155 1 × 101 1 × 101 1 × 101 1 × 101 1 × 102 1 × 101 1 × 102 1 × 101 1 × 103 1 × 106 1 × 106 1 × 106 1 × 106 1 × 107 1 × 106 1 × 107 1 × 106 1 × 107 1 × 104 1 × 107 1 × 104 1 × 101 1 × 101 1 × 103 1 × 101 1 × 102 1 × 103 1 × 103 1 × 103 1 × 102 1 × 107 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 107 1 × 106 1 × 106 1 × 106 TABLE I. LEVELS FOR EXEMPTION OF MODERATE AMOUNTS OF MATERIAL WITHOUT FURTHER CONSIDERATION: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES (cont....) Radionuclides Ho-157 Ho-159 Ho-161 Ho-162 Ho-162m Ho-164 Ho-164m Activity Concentration (Bq/g) 1 × 102 1 × 102 1 × 102 1 × 102 1 × 101 1 × 103 1 × 103 Activity (Bq) 1 × 106 1 × 106 1 × 107 1 × 107 1 × 106 1 × 106 1 × 107 Radionuclides Lu-172 Lu-173 Lu-174 Lu-174m Lu-176 Lu-176m Lu-177 Activity Concentration (Bq/g) 1 × 101 1 × 102 1 × 102 1 × 102 1 × 102 1 × 103 1 × 103 Activity (Bq) 1 × 106 1 × 107 1 × 107 1 × 107 1 × 106 1 × 106 1 × 107 100 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Ho-166 Ho-166m Ho-167 Er-161 Er-165 Er-169 Er-171 Er-172 Tm-162 Tm-166 Tm-167 Tm-170 Tm-171 Tm-172 Tm-173 Tm-175 Yb-162 Yb-166 Yb-167 Yb-169 Yb-175 Yb-177 Yb-178 Lu-169 Lu-170 Lu-171 1 × 103 1 × 101 1 × 102 1 × 101 1 × 103 1 × 104 1 × 102 1 × 102 1 × 101 1 × 101 1 × 102 1 × 103 1 × 104 1 × 102 1 × 102 1 × 101 1 × 102 1 × 102 1 × 102 1 × 102 1 × 103 1 × 102 1 × 103 1 × 101 1 × 101 1 × 101 1 × 105 Lu-177m 1 × 106 Lu-178 1 × 106 Lu-178m 1 × 106 Lu-179 1 × 107 Hf-170 1 × 107 Hf-172b 1 × 106 Hf-173 1 × 106 Hf-175 1 × 106 Hf-177m 1 × 106 Hf-178m 1 × 106 Hf-179m 1 × 106 Hf-180m 1 × 108 Hf-181 1 × 106 Hf-182 1 × 106 Hf-182m 1 × 106 Hf-183 1 × 107 Hf-184 1 × 107 Ta-172 1 × 106 Ta-173 1 × 107 Ta-174 1 × 107 Ta-175 1 × 106 Ta-176 1 × 106 Ta-177 1 × 106 Ta-178 1 × 106 Ta-179 1 × 106 Ta-180 1 × 101 1 × 102 1 × 101 1 × 103 1 × 102 1 × 101 1 × 102 1 × 102 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 102 1 × 101 1 × 101 1 × 102 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 102 1 × 101 1 × 103 1 × 101 1 × 106 1 × 105 1 × 105 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 105 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 107 1 × 106 1 × 107 1 × 106 TABLE I. LEVELS FOR EXEMPTION OF MODERATE AMOUNTS OF MATERIAL WITHOUT FURTHER CONSIDERATION: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES (cont....) Radionuclides Ta-180m Ta-182 Ta-182m Activity Concentration (Bq/g) 1 × 103 1 × 101 1 × 102 Activity (Bq) Radionuclides 1 × 107 Os-191 1 × 104 Os-191m 1 × 106 Os-193 101 Activity Concentration (Bq/g) 1 × 102 1 × 103 1 × 102 Activity (Bq) 1 × 107 1 × 107 1 × 106 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Ta-183 Ta-184 Ta-185 Ta-186 W-176 W-177 W-178b W-179 W-181 W-185 W-187 W-188b Re-177 Re-178 Re-181 Re-182 Re-182m Re-184 Re-184m Re-186 Re-186m Re-187 Re-188 Re-188m Re-189b Os-180 Os-181 Os-182 Os-185 Os-189m 1 × 102 1 × 101 1 × 102 1 × 101 1 × 102 1 × 101 1 × 101 1 × 102 1 × 103 1 × 104 1 × 102 1 × 106 Os-194b 1 × 106 1 × 105 1 × 105 1 × 106 1 × 106 1 × 106 1 × 107 1 × 107 1 × 107 1 × 106 1 × 102 1 × 105 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 102 1 × 103 1 × 103 1 × 106 1 × 102 1 × 102 1 × 102 1 × 102 1 × 101 1 × 102 1 × 101 1 × 104 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 107 1 × 109 1 × 105 1 × 107 1 × 106 1 × 107 1 × 106 1 × 106 1 × 106 1 × 107 Ir-182 Ir-184 Ir-185 Ir-186 Ir-186m Ir-187 Ir-188 Ir-189b Ir-190 Ir-190m (3.1 h) Ir‑190mʹ (1.2 h) Ir-192 Ir-192m Ir-193m Ir-194 Ir-194m Ir-195 Ir-195m Pt-186 Pt-188b Pt-189 Pt-191 Pt-193 Pt-193m Pt-195m Pt-197 Pt-197m Pt-199 Pt-200 1 × 102 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 102 1 × 101 1 × 102 1 × 101 1 × 101 1 × 105 1 × 105 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 107 1 × 106 1 × 106 1 × 104 1 × 107 1 × 101 1 × 102 1 × 104 1 × 102 1 × 101 1 × 102 1 × 102 1 × 101 1 × 101 1 × 102 1 × 102 1 × 104 1 × 103 1 × 102 1 × 103 1 × 102 1 × 102 1 × 102 1 × 104 1 × 107 1 × 107 1 × 105 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 107 1 × 107 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 TABLE I. LEVELS FOR EXEMPTION OF MODERATE AMOUNTS OF MATERIAL WITHOUT FURTHER CONSIDERATION: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES (cont....) 102 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Radionuclides Au-193 Au-194 Au-195 Au-198 Au-198m Au-199 Au-200 Au-200m Au-201 Hg-193 Hg-193m Hg-194b Hg-195 Hg-195mb Hg-197 Hg-197m Hg-199m Hg-203 Tl-194 Tl-194m Tl-195 Tl-197 Tl-198 Tl-198m Tl-199 Tl-200 Tl-201 Tl-202 Tl-204 Pb-195m Pb-198 Pb-199 Pb-200 Activity Concentration (Bq/g) 1 × 102 1 × 101 1 × 102 1 × 102 1 × 101 1 × 102 1 × 102 1 × 101 1 × 102 1 × 102 1 × 101 1 × 101 1 × 102 1 × 102 1 × 102 1 × 102 1 × 102 1 × 102 1 × 101 1 × 101 1 × 101 1 × 102 1 × 101 1 × 101 1 × 102 1 × 101 1 × 102 1 × 102 1 × 104 1 × 101 1 × 102 1 × 101 1 × 102 Activity (Bq) Radionuclides 1 × 107 Pb-201 1 × 106 Pb-202 1 × 107 Pb-202m 1 × 106 Pb-203 1 × 106 Pb-205 1 × 106 Pb-209 Pb-210b 1 × 105 1 × 106 Pb-211 Pb-212b 1 × 106 1 × 106 Pb-214 1 × 106 Bi-200 1 × 106 Bi-201 1 × 106 Bi-202 1 × 106 Bi-203 1 × 107 Bi-205 1 × 106 Bi-206 1 × 106 Bi-207 1 × 105 Bi-210 1 × 106 Bi-210mb 1 × 106 Bi-212b 1 × 106 Bi-213 1 × 106 Bi-214 1 × 106 Po-203 1 × 106 Po-205 1 × 106 Po-206 1 × 106 Po-207 1 × 106 Po-208 1 × 106 Po-209 1 × 104 Po-210 1 × 106 At-207 1 × 106 At-211 1 × 106 Fr-222 1 × 106 Fr-223 103 Activity Concentration (Bq/g) 1 × 101 1 × 103 1 × 101 1 × 102 1 × 104 1 × 105 1 × 101 1 × 102 1 × 101 1 × 102 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 103 1 × 101 1 × 101 1 × 102 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 101 1 × 103 1 × 103 1 × 102 Activity (Bq) 1 × 106 1 × 106 1 × 106 1 × 106 1 × 107 1 × 106 1 × 104 1 × 106 1 × 105 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 106 1 × 105 1 × 106 1 × 106 1 × 105 1 × 105 1 × 106 1 × 105 1 × 106 1 × 106 1 × 106 1 × 106 1 × 104 1 × 104 1 × 104 1 × 106 1 × 107 1 × 105 1 × 106 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) TABLE I. LEVELS FOR EXEMPTION OF MODERATE AMOUNTS OF MATERIAL WITHOUT FURTHER CONSIDERATION: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES (cont....) Radionuclides Rn-220b Rn-222b Ra-223b Ra-224b Ra-225 Ra-226b Ra-227 Ra-228b Ac-224 Ac-225b Ac-226 Ac-227b Ac-228 Th-226b Th-227 Th-228b Th-229b Th-230 Th-231 Th-232 Th-234b Pa-227 Pa-228 Pa-230 Pa-231 Pa-232 Pa-233 Pa-234 U-230b U-231 Activity Concentration (Bq/g) 1 × 104 1 × 101 1 × 102 1 × 101 1 × 102 1 × 101 1 × 102 1 × 101 1 × 102 1 × 101 1 × 102 1 × 10–1 1 × 101 1 × 103 1 × 101 1 × 100 1 × 100 1 × 100 1 × 103 1 × 101 1 × 103 1 × 101 1 × 101 1 × 101 1 × 100 1 × 101 1 × 102 1 × 101 1 × 101 1 × 102 Activity (Bq) Radionuclides 1 × 107 U-235b 1 × 108 U-236 1 × 105 U-237 1 × 105 U-238b 1 × 105 U-239 1 × 104 U-240 1 × 106 U-240b 1 × 105 Np-232 1 × 106 Np-233 1 × 104 Np-234 1 × 105 Np-235 1 × 103 Np-236 1 × 106 Np-236m 1 × 107 Np-237b 1 × 104 Np-238 1 × 104 Np-239 1 × 103 Np-240 1 × 104 Pu-234 1 × 107 Pu-235 1 × 104 Pu-236 1 × 105 Pu-237 1 × 106 Pu-238 1 × 106 Pu-239 1 × 106 Pu-240 1 × 103 Pu-241 1 × 106 Pu-242 1 × 107 Pu-243 1 × 106 Pu-244 1 × 105 Pu-245 1 × 107 Pu-246 104 Activity Concentration (Bq/g) 1 × 101 1 × 101 1 × 102 1 × 101 1 × 102 1 × 103 1 × 101 1 × 101 1 × 102 1 × 101 1 × 103 1 × 102 1 × 103 1 × 100 1 × 102 1 × 102 1 × 101 1 × 102 1 × 102 1 × 101 1 × 103 1 × 100 1 × 100 1 × 100 1 × 102 1 × 100 1 × 103 1 × 100 1 × 102 1 × 102 Activity (Bq) 1 × 104 1 × 104 1 × 106 1 × 104 1 × 106 1 × 107 1 × 106 1 × 106 1 × 107 1 × 106 1 × 107 1 × 105 1 × 107 1 × 103 1 × 106 1 × 107 1 × 106 1 × 107 1 × 107 1 × 104 1 × 107 1 × 104 1 × 104 1 × 103 1 × 105 1 × 104 1 × 107 1 × 104 1 × 106 1 × 106 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) U-232b U-233 U-234 1 × 100 1 × 101 1 × 101 1 × 103 Am-237 1 × 104 Am-238 1 × 104 Am-239 1 × 102 1 × 101 1 × 102 1 × 106 1 × 106 1 × 106 TABLE I. LEVELS FOR EXEMPTION OF MODERATE AMOUNTS OF MATERIAL WITHOUT FURTHER CONSIDERATION: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES (cont....) Radionuclides Am-240 Am-241 Am-242 Am-242mb Am-243b Am-244 Am-244m Am-245 Am-246 Am-246m Cm-238 Cm-240 Cm-241 Cm-242 Cm-243 Cm-244 Cm-245 Cm-246 Cm-247 Cm-248 Cm-249 Cm-250 Bk-245 Bk-246 Activity Concentration (Bq/g) 1 × 101 1 × 100 1 × 103 1 × 100 1 × 100 1 × 101 1 × 104 1 × 103 1 × 101 1 × 101 1 × 102 1 × 102 1 × 102 1 × 102 1 × 100 1 × 101 1 × 100 1 × 100 1 × 100 1 × 100 1 × 103 1 × 10–1 1 × 102 1 × 101 Activity Concentration (Bq/g) 1 × 100 1 × 103 1 × 101 1 × 104 1 × 103 1 × 101 1 × 100 1 × 101 1 × 100 1 × 101 1 × 102 1 × 100 1 × 102 1 × 102 1 × 102 1 × 101 1 × 102 1 × 103 1 × 102 1 × 104 1 × 103 1 × 101 1 × 102 1 × 102 Activity (Bq) 1 × 104 1 × 106 1 × 106 1 × 107 1 × 106 1 × 104 1 × 103 1 × 104 1 × 103 1 × 104 1 × 105 1 × 103 1 × 106 1 × 107 1 × 105 1 × 104 1 × 106 1 × 106 1 × 106 1 × 107 1 × 106 1 × 105 1 × 107 1 × 105 Activity (Bq) Radionuclides 1 × 106 Bk-247 1 × 104 Bk-249 1 × 106 Bk-250 1 × 104 Cf-244 1 × 103 Cf-246 1 × 106 Cf-248 1 × 107 Cf-249 1 × 106 Cf-250 1 × 105 Cf-251 1 × 106 Cf-252 1 × 107 Cf-253 1 × 105 Cf-254 1 × 106 Es-250 1 × 105 Es-251 1 × 104 Es-253 1 × 104 Es-254 1 × 103 Es-254m 1 × 103 Fm-252 1 × 104 Fm-253 1 × 103 Fm-254 1 × 106 Fm-255 1 × 103 Fm-257 1 × 106 Md-257 1 × 106 Md-258 105 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) a. m and mʹ denote metastable states of the radionuclide. The metastable state mʹ is of higher energy than the metastable state m. b. Parent radionuclides and their progeny whose dose contributions are taken into account in the dose calculations (thus requiring only the exemption level of the parent radionuclide to be considered) are listed here: Ge-68 Rb-83 Sr-82 Sr-90 Ag-108m Sn-121m Sn-126 Xe-122 Cs-137 Ba-140 Ce-134 Ce-144 Gd-146 Hf-172 W-178 W-188 Re-189 Ir-189 Pt-188 Hg-194 Hg-195m Pb-210 Pb-212 Bi-210m Bi-212 (0.64) Rn-220 Rn-222 214, Ra-223 211, Ra-224 212, Ga-68 Kr-83m Rb-82 Y-90 Ag-108 Sn-121 (0.776) Sb-126m I-122 Ba-137m La-140 La-134 Pr-144 Eu-146 Lu-172 Ta-178 Re-188 Os-189m (0.241) Os-189m Ir-188 Au-194 Hg-195 (0.542) Bi-210, Po-210 Bi-212, Tl-208 (0.36), Po-212 (0.64) Tl-206 Tl-208 (0.36), Po-212 Po-216 Po-218, Pb-214, Bi- Po-214 Rn-219, Po-215, Pb- Bi-211, Tl-207 Rn-220, Po-216, Pb- Y-87 Zr-93 Zr-97 Ru-106 Ra-226 214, Ra-228 Ac-225 Ac-227 Th-226 Th-228 216, (0.36), Th-229 221, Th-234 U-230 218, U-232 220, Sr-87m Nb-93m Nb-97 Rh-106 Rn-222, Po-218, Pb- Bi-214, Po-214, Pb-210, Bi-210, Po-210 Ac-228 Fr-221, At-217, Bi-213, Po-213 (0.978), Tl-209 (0.0216), Pb-209 (0.978) Fr-223 (0.0138) Ra-222, Rn-218, Po-214 Ra-224, Rn-220, Po- Pb-212, Bi-212,Tl-208 Po-212 (0.64) Ra-225, Ac-225, Fr- At-217, Bi-213, Po-213, Pb-209 Pa-234m Th-226, Ra-222, Rn- Po-214 Th-228, Ra-224, Rn- Po-216, Pb-212, Bi-212, Tl-208 (0.36), Po-212 (0.64) Th-231 Th-234, Pa-234m Np-240m U-235 U-238 U-240 106 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Bi-212, Tl-208 (0.36), Po-212 (0.64) Np-237 Am-242m Am-243 Pa-233 Am-242 Np-239 TABLE 2. LEVELS FOR EXEMPTION OF BULK AMOUNTS OF SOLID MATERIAL WITHOUT FURTHER CONSIDERATION AND FOR CLEARANCE OF SOLID MATERIAL ACTIVITY CONSIDERATION: CONCENTRATIONS OF RADIONUCLIDES OF ARTIFICIAL ORIGIN WITHOUT FURTHER Radionuclides H-3 Be-7 C-14 F-18 Na-22 Na-24 Si-31 P-32 P-33 S-35 Cl-36 Cl-38 K-42 K-43 Ca-45 Ca-47 Sc-46 Sc-47 Sc-48 V-48 Cr-51 Mn-51 Mn-52 Mn-52m Mn-53 Mn-54 Mn-56 Fe-52a Activity Concentration (Bq/g) (Bq/g) 100 10 1 10 0.1 1 1 000 1 000 1 000 100 1 10 100 10 100 10 0.1 100 1 1 100 10 1 10 100 0.1 10 10 Radionuclides Co-58 Co-58m Co-60 Co-60m Co-61 Co-62m Ni-59 Ni-63 Ni-65 Cu-64 Zn-65 Zn-69 Zn-69ma Ga-72 Ge-71 As-73 As-74 As-76 As-77 Se-75 Br-82 Rb-86 Sr-85 Sr-85m Sr-87m Sr-89 Sr-90a Sr-91a 107 Activity Concentration (Bq/g) 1 10 000 0.1 1 000 100 10 100 100 10 100 0.1 1 000 10 10 10 000 1 000 10 10 1 000 1 1 100 1 100 100 1 000 1 10 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Fe-55 Fe-59 Co-55 Co-56 Co-57 1 000 1 10 0.1 1 Sr-92 Y-90 Y-91 Y-91m Y-92 10 1 000 100 100 100 TABLE 2. LEVELS FOR EXEMPTION OF BULK AMOUNTS OF SOLID MATERIAL WITHOUT FURTHER CONSIDERATION AND FOR CLEARANCE OF SOLID MATERIAL ACTIVITY CONSIDERATION: CONCENTRATIONS OF RADIONUCLIDES OF ARTIFICIAL ORIGIN WITHOUT FURTHER Radionuclides Y-93 Zr-93 Zr-95a Zr-97a Nb-93m Nb-94 Nb-95 Nb-97a Nb-98 Mo-90 Mo-93 Mo-99a Mo-101a Tc-96 Tc-96m Tc-97 Tc-97m Tc-99 Tc-99m Ru-97 Ru-103a Ru-105a Ru-106a Activity Concentration (Bq/g) Radionuclides 100 10 1 10 10 0.1 1 10 10 10 10 10 10 1 1 000 10 100 1 100 10 1 10 0.1 In-111 In-113m In-114ma In-115m Sn-113a Sn-125 Sb-122 Sb-124 Sb-125a Te-123m Te-125m Te-127 Te-127ma Te-129 Te-129ma Te-131 Te-131ma Te-132a Te-133 Te-133m Te-134 I-123 I-125 108 Activity Concentration (Bq/g) 10 100 10 100 1 10 10 1 0.1 1 1 000 1 000 10 100 10 100 10 1 10 10 10 100 100 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Rh-103m Rh-105 Pd-103a Pd-109a Ag-105 Ag-110ma Ag-111 Cd-109a Cd-115a Cd-115ma 10 000 100 1 000 100 1 0.1 100 1 10 100 I-126 I-129 I-130 I-131 I-132 I-133 I-134 I-135 Cs-129 Cs-131 10 0.01 10 10 10 10 10 10 10 1 000 TABLE 2. LEVELS FOR EXEMPTION OF BULK AMOUNTS OF SOLID MATERIAL WITHOUT FURTHER CONSIDERATION AND FOR CLEARANCE OF SOLID MATERIAL ACTIVITY FURTHER CONCENTRATIONS OF RADIONUCLIDES OF ARTIFICIAL ORIGIN (cont..) CONSIDERATION: WITHOUT Radionuclides Cs-132 Cs-134 Cs-134m Cs-135 Cs-136 Cs-137a Cs-138 Ba-131 Ba-140 La-140 Ce-139 Ce-141 Ce-143 Ce-144a Pr-142 Pr-143 Nd-147 Nd-149 Pm-147 Pm-149 Sm-151 Activity Concentration (Bq/g) 10 0.1 1 000 100 1 0.1 10 10 1 1 1 100 10 10 100 1 000 100 100 1 000 1 000 1 000 Radionuclides Er-171 Tm-170 Tm-171 Yb-175 Lu-177 Hf-181 Ta-182 W-181 W-185 W-187 Re-186 Re-188 Os-185 Os-191 Os-191m Os-193 Ir-190 Ir-192 Ir-194 Pt-191 Pt-193m 109 Activity Concentration (Bq/g) 100 100 1 000 100 100 1 0.1 10 1 000 10 1 000 100 1 100 1 000 100 1 1 100 10 1 000 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Sm-153 Eu-152 Eu-152m Eu-154 Eu-155 Gd-153 Gd-159 Tb-160 Dy-165 Dy-166 Ho-166 Er-169 100 0.1 100 0.1 1 10 100 1 1 000 100 100 1 000 Pt-197 Pt-197m Au-198 Au-199 Hg-197 Hg-197m Hg-203 Tl-200 Tl-201 Tl-202 Tl-204 Pb-203 1 000 100 10 100 100 100 10 10 100 10 1 10 TABLE 2. LEVELS FOR EXEMPTION OF BULK AMOUNTS OF SOLID MATERIAL WITHOUT FURTHER CONSIDERATION AND FOR CLEARANCE OF SOLID MATERIAL ACTIVITY FURTHER CONCENTRATIONS OF RADIONUCLIDES OF ARTIFICIAL ORIGIN (cont.) CONSIDERATION: WITHOUT Radionuclides Bi-206 Bi-207 Po-203 Po-205 Activity Concentration (Bq/g) 1 0.1 10 10 Po-207 At-211 Ra-225 Ra-227 Th-226 Th-229 Pa-230 Pa-233 U-230 U-231 U-232a U-233 U-236 U-237 U-239 U-240a 10 1 000 10 100 1 000 0.1 10 10 10 100 0.1 1 10 100 100 100 Radionuclides Pu-241 Pu-242 Pu-243 Pu-244a Am-241 Am-242 Am-242ma Am-243a Cm-242 Cm-243 Cm-244 Cm-245 Cm-246 Cm-247a Cm-248 Bk-249 Cf-246 Cf-248 Cf-249 Cf-250 Activity Concentration (Bq/g) 10 0.1 1 000 0.1 0.1 1 000 0.1 0.1 10 1 1 0.1 0.1 0.1 0.1 100 1 000 1 0.1 1 110 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Np-237a Np-239 Np-240 Pu-234 Pu-235 Pu-236 Pu-237 Pu-238 Pu-239 Pu-240 1 100 10 100 100 1 100 0.1 0.1 0.1 Cf-251 Cf-252 Cf-253 Cf-254 Es-253 Es-254a Es-254ma Fm-254 Fm-255 0.1 1 100 1 100 0.1 10 10 000 100 a. Parent radionuclides, and their progeny whose dose contributions are taken into account in the dose calculations (thus requiring only the exemption level of the parent radionuclide to be considered), are listed here: Fe-52 Mn-52m Zn-69m Zn-69 Sr-90 Y-90 Sr-91 Y-91m Zr-95 Nb-95 Zr-97 Nb-97m, Nb-97 Nb-97 Nb-97m Mo-99 Tc-99m Mo-101 Tc-101 Ru-103 Rh-103m Ru-105 Rh-105m Ru-106 Rh-106 Pd-103 Rh-103m Pd-109 Ag-109m Ag-110m Ag-110 Cd-109 Ag-109m Cd-115 In-115m Cd-115m In-115m In-114m In-114 Sn-113 In-113m Sb-125 Te-125m Te-127m Te-127 Te-129m Te-129 Te-131m Te-131 Te-132 I-132 Cs-137 Ba-137m Ce-144 Pr-144, Pr-144m U-232 Th-228, Ra-224, Rn-220, Po-216, Pb-212, Bi-212, Tl-208 U-240 Np-240m, Np-240 Np-237 Pa-233 Pu-244 U-240, Np-240m, Np-240 Am-242m Np-238 Am-243 Np-239 Cm-247 Pu-243 Es-254 Bk-250 Es-254m Fm-254 CRITERIA FOR CLEARANCE 1. The general criteria for clearance are that: 111 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (a) radiation risks arising from the cleared material are sufficiently low as not to warrant regulatory control, and there is no appreciable likelihood of occurrence for 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 reduction of health risks. 2. Material may be cleared without further consideration under paragraph of 1(a) of this Schedule provided that in reasonably foreseeable circumstances the effective dose expected to be incurred by any individual owing to the cleared material is of the order of 10 μSv or less in a year. To take into account low probability scenarios, a different criterion can be used, namely that the effective dose expected to be incurred by any individual for such low probability scenarios does not exceed 1 mSv in a year. 3. Radioactive material within a notified practice or an authorised practice may be cleared without further consideration provided that: (a) The activity concentration of an individual radionuclide of artificial origin in solid form does not exceed the relevant level given in Table 2; or (b) the activity concentrations of radionuclides of natural origin do not exceed the relevant level given in Table 3; 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 contamination of drinking water supplies, the activity concentration 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. Clearance may be granted by the Commission for specific situations, on the basis of the criteria of 1 and 2, 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 activity concentration per unit mass or activity concentration 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 2, the conditions for clearance is that the sum of the activity concentrations for individual radionuclides is less than the derived clearance level for the mixture (Xm), determined as follows: 112 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) where f(i) is the fraction of activity concentration of radionuclide i in the mixture; X(i) is the applicable level for radionuclide i as given in Table 2; and n is the number of radionuclides present. 5 For clearance of bulk quantities of material containing a mixture of radionuclides of natural origin and radionuclides of artificial origin, the conditions given in criteria 12 and 14 both have to be satisfied. TABLE CONCENTRATIONS OF RADIONUCLIDES OF NATURAL ORIGIN FOR CLEARANCE OF MATERIAL: ACTIVITY LEVELS 3. Radionuclide K-40 Each radionuclide in the uranium decay chain or the thorium decay chain Activity concentration (Bq/g) 10 1 113 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) _________________ SECOND SCHEDULE _________________ (Made under regulations 6(g), 24(2), 25(1), 38(2)(a) and 60(2)(b)(ii)) DOSE LIMITS FOR PLANNED EXPOSURES SITUATIONS OCCUPATIONAL EXPOSURE. 1. For occupational exposure of over the age of 18 years, the dose limits are: (a) An effective dose of 20 mSv per year averaged over five consecutive years (100 mSv in 5 years) and of 50 mSv in any single year; (b) An equivalent dose to the lens of the eye of 20 mSv per year averaged over five consecutive years (100 mSv in 5 years) and of 50 mSv in any single year; (c) An equivalent dose to the extremities namely hands and feet or to the skin of 500 mSv in a year. Additional restrictions apply to occupational exposure for a female worker who has notified that is pregnant or is breast-feeding. 2. For occupational exposure of apprentices of 16 to 18 years of age who are being trained for employment involving radiation and for exposure of students of age 16 to 18 who use sources in the course of their studies, the dose limits are: (i) An effective dose of 6 mSv in a year; (ii) An equivalent dose to the lens of the eye of 20 mSv in a year; (iii) An equivalent dose to the extremities namely hands and feet or to the skin of 150 mSv in a year. SPECIALCIRCUMSTANCES 1. When, in special circumstances, a temporary change in the dose limitation requirements is approved pursuant to regulation 50: 114 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (a) the dose average period mentioned in paragraph (a) above may exceptionally be up to 10 consecutive years as specified by the Commission, and the effective dose for any worker shall be reviewed when the dose accumulated by any worker since the start of the extended averaging period reaches 100 mSv; or the temporary change in dose limitation shall be as specified by the Commission, but shall not exceed 50 mSv in any year and the period of the temporary change shall not exceed 5 years. 115 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) PUBLIC EXPOSURE 3. For public exposure, the dose limits are: (a) an effective dose of 1 mSv in a year; (b) in special circumstances, a higher value of effective dose in a single year could apply, provided that the average effective dose over five consecutive years does not exceed 1 mSv per year; (c) an equivalent dose to the lens of the eye of 15 mSv in a year; (d) an equivalent dose to the skin of 50 mSv in a year. VERIFICATION OF COMPLIANCE WITH DOSE LIMITS 4. The effective dose limits specified in this schedule apply to the sum of the relevant doses from external exposure in the specified period and the relevant committed doses from intakes in the same period; the period for calculating the committed dose shall normally be 50 years for intakes by adults and shall be up to age 70 years for intakes by children. 5. For occupational exposure, the personal dose equivalent Hp(10) may be used as an approximation of the effective dose from external exposure to penetrating radiation. INTERNAL EXPOSURE 6. Internal exposure caused by inhalation or ingestion of radioactive substances shall be estimated in accordance with the methodologies, parameters and value contained in the current IAEA GSR-Part 3 DOSE LIMITATION FOR COMFORTERS AND VISITORS OF PATIENTS 7. The dose limits set out in this part shall not apply to comforters or visitors of patients. However, the dose of any such comforter or visitor shall be constrained so that it is unlikely that the dose will exceed 5 mSv during the period of the diagnostic examination or treatment. The dose to children visiting patients who have ingested or have been injected radioactive materials shall be similarly constrained to less than 1 mSv. 116 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) _________________ THIRD SCHEDULE _________________ (Made under regulation 48(2)) MEDICAL EXPOSURE - DESIGN AND OPERATIONAL REQUIREMENTS Design of sources and equipment 1. The requirements for the safety of sources specified in Regulation 58 of these Regulations shall apply to sources used in medical exposure where relevant and, in particular, equipment used in medical exposure shall be so designed that: (a) failure of equipment or components can be promptly detected so that any unplanned exposure of patients can be avoided or minimized; and (b) the risk of delivering unplanned exposure to patients by human error is minimized. 2. Licensees, in co-operation with suppliers where relevant or appropriate, shall: (i) ensure that radiation generators, sources and accessories are designed and manufactured so as to facilitate the keeping of medical exposures as low as reasonably achievable consistent with obtaining adequate diagnostic information or therapeutic results; (ii) ensure that equipment containing sources for medical exposure conform to applicable international such as International Electrotechnical Commission (IEC) , International Standards Organisation (ISO) and national standards; (iii) ensure that performance specifications and operating and maintenance instructions, including radiation safety aspects, are provided in a major world language understandable to the users as well as in the language; (iv) identify and take all reasonable measures to prevent failures and human error that could result in unplanned medical exposures, including the establishment of adequate procedures for calibration, quality assurance and operation of diagnostic and therapeutic equipment as well as the selection, training and periodic retraining of suitably qualified personnel; (v) ensure that any radiation emitting equipment is provided with radiation beam control mechanisms, including safety interlocks and clear and fail-safe “on-off” indicators; (vi) ensure that devices are provided to limit the exposure to the area being examined or treated and keep exposure rates outside this area, due to radiation leakage or scattering, as low as reasonably achievable; 117 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) vii. ensure that, when appropriate, monitoring equipment is installed or is available to give warning of an unusual situation or trend in the use of radiation emitting equipment for diagnostic or therapeutic applications. OPERATIONAL ASPECTS Diagnostic exposure 1. Licensees shall make sure that: (a) the medical practitioners who prescribe or conduct radiological diagnostic examinations: (i) ensure that the appropriate equipment is used; (ii) ensure that the exposure of patients is the minimum necessary to achieve the required diagnostic objective, taking into account norms of acceptable image quality established by appropriate professional bodies and relevant diagnostic reference levels for medical exposure; (iii) take into account relevant information from previous examination in order to avoid unnecessary additional examinations; (iv) avoid radiological examinations causing exposure of the abdomen or pelvis of women who are pregnant or likely to be pregnant unless there are strong clinical reasons for such examinations; (v) plan any diagnostic examination of the abdomen or pelvis of women of reproductive capacity so as to deliver the minimum dose to any embryo or foetus that might be present; (vi) ensure that portable and mobile radiological equipment is used only for examinations where it is impractical or not medically acceptable to transfer patients to a stationary radiological installation and only after proper attention has been given to the radiation protection measures required in its use; and (vii) ensure that, whenever feasible, shielding of radiosensitive organs such as the gonads, lens of the eye, breast and thyroid is provided as appropriate. (b) the medical practitioner, the technologist or other imaging staff select the following parameters, as relevant, such that their combination produce the minimum patient exposure consistent with acceptable image quality and the clinical purpose of the examination, paying particular attention to this selection for pediatric radiology and interventional radiology: (i) the area to be examined, the number and size of views per examination .example number of films or computed tomography slices or the time per examination example fluoroscopic time); (ii) the type of image receptor such as high versus low speed screens; 118 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) (iii) the use of anti-scatter grids; (iv) proper collimation of the primary X-ray beam to minimize the volume of patient tissue being irradiated and to improved image quality; (v) appropriate values of operational parameters such as tube generating potential current and time or their product); (vi) appropriate image storage techniques in dynamic imaging example number of images per second; and (vii) adequate image processing facilities such as developer, temperature c o n t r o l d e v i c e and image reconstruction algorithms 4. Nuclear medicine Licensees shall make sure that: (a) the medical practitioners who prescribe or conduct diagnostic applications of radionuclides: (i) ensure that the exposure of patients is the minimum required to achieve the intended diagnostic objective taking into account relevant diagnostic reference levels for medical exposure; take into account relevant information from previous examinations in order to avoid unnecessary additional examinations; avoid administration of radionuclides for diagnostic procedures; avoid administration of radionuclides for diagnostic procedure to pregnant women or who are likely to be pregnant unless there are strong clinical indications to justify such procedures; for mothers in lactation, recommend discontinuation of nursing until the radiopharmaceutical is no longer secreted in an amount estimated to give an unacceptable effective dose to the nursing; and ensure for diagnostic procedures is carried out only if there is a strong clinical indication, and the activity of the radionuclides administered is reduced according to body weight, body surface area or other appropriate criteria; the medical practitioner, the technologist, radiologist or other imaging staff, as appropriate, that administration of radionuclides to children (ii) (iii) (iv) (v) (vi) (vii) (viii) endeavor to achieve the minimum patient exposure consistent with acceptable image quality by: (a) appropriate selection of the best available radiopharmaceutical and its activity, noting the special requirements for children and for patients with impairment of organ function; (b) use of methods for blocking the uptake in organs not under study and for accelerated excretion when applicable; and (c) appropriate image acquisition and processing. 119 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) 5. Therapeutic exposure Licensees shall make sure that the medical practitioners who prescribe or conduct radiotherapy procedures with radiation sources or with radionuclides: (a) the prescribed absorbed dose is delivered to the planning target volume or organ; (b) exposure of normal tissue during radiotherapy is kept as low as reasonably achievable consistent with delivering the required dose to the planning target volume, and organ shielding is used when feasible and appropriate; (c) avoid radiotherapeutic procedures causing exposure of the abdomen or pelvis of women who are pregnant or likely to be pregnant unless there are strong clinical indications; (d) avoid administration of radionuclides for therapeutic procedures to women who are pregnant or likely to be pregnant or who are nursing, unless there are strong clinical indications; (e) plan any therapeutic procedure for pregnant women so as to deliver the minimum dose to any embryo or foetus; and (f) inform the patient of possible risks. 120 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) _________________ FOURTH SCHEDULE _________________ (Made under regulations 25(1) and 51(b)) GUIDANCE LEVELS OF DOSE, DOSE RATE AND ACTIVITY FOR MEDICAL EXPOSURE GUIDANCE LEVELS FOR DIAGNOSTIC RADIOLOGY PROCEDURES GUIDANCE LEVELS OF DOSE FOR DIAGNOSTIC RADIOGRAPHY FOR A TYPICAL ADULT PATIENT Examination Entrance surface dose per radiographa (mGy) AP 10 Lumbar spine LAT 30 LSJ 40 Abdomen, intravenous urography And cholecystography AP 10 Pelvis AP 10 Hip joint AP 10 Chest AP 0.4 LAT 1.5 Thoracic spine AP 7 Dental Periapical 7 AP 5 Skull PA 5 LAT 3 121 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) DOSE GUIDANCE LEVELS FOR COMPUTED TOMOGRAPHY FOR A TYPICAL ADULT PATIENT Examination Multiple scan average dosea (mGy) Head 50 Lumbar spine 35 Abdomen 25 a Delivered from measurements on the axis of rotation in water equivalent phantoms, 15 cm in length and 16 cm (head) and 30 cm (lumbar spine and abdomen) in diameter. DOSE GUIDANCE LEVELS FOR MAMMOGRAPHY FOR A TYPICAL ADULT PATIENT Average glandular dose per cranio-caudal projectiona 1 mGy (without grid) 3 mGy (with grid) a Determined in a 4.5 cm compressed breast consisting of 50% glandular and 50% adipose tissue, for film-screen systems and dedicated Mo-target Mo-filter mammography units. DOSE RATE GUIDANCE LEVELS FOR FLUOROSCOPY FOR A TYPICAL ADULT PATIENT Mode of operation Entrance surface dose ratea (mGy/min) Normal 25 High Levelb 100 a In air with backscatter b For fluoroscopes that have an optional ‘high level’ operational mode, such as those frequently used in interventional radiology. GUIDANCE LEVELS FOR DIAGNOSTIC PROCEDURES IN NUCLEAR MEDICINE 122 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) GUIDANCE LEVELS OF ACTIVITY FOR PROCEDURES IN NUCLEAR MEDICINE FOR A TYPICAL ADULT PATIENT Test Radionuclide Chemical form maximum usual Activity per testb (MBq) Bone 99Tcm Bone imaging Phosphate compounds Phosphate and 600 Bone imaging by single 99Tcm Photon emission computerized Phosphate compounds 800 Tomography (SPECT) Phosphate and Bone marrow imaging 99Tcm labeled colloid 400 Brain Brain imaging (static) 99Tcm TcO4 500 99Tcm DTPA, gluconate and glucoheptonate 500 Brain imaging (SPECT) 99Tcm TcO4 800 99Tcm DTPA, gluconate and 800 glucoheptonate 99Tcm Exametazime 500 Cerebral blood flow 133Xe In isotonic sodium 400 Chloride solution 99Tcm Hexamethyl propylene 500 amine oxime (HM-PAO) Cisternography 111In DTPA 40 Lacrimal Lacrimal drainage 99Tcm TcO1 4 4 99Tcm Labelled colloid 4 123 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Thyroid Thyroid imaging 99Tcm TcO - 4 200 123I I- 20 Thyroid metastases 131I I- 400 (after ablation) Parathyroid imaging 201TI TI+, chloride 80 Lung Lung ventilation imaging 81Krm Gas 600 99Tcm DTPA-aerosol 80 133Xe Lung ventilation study 127Xe Gas Gas 400 200 Lung perfusion imaging 81Krm Aqueous solution 6000 Lung perfusion imaging (with venography) 99Tcm 99Tcm Human albumin (macroaggregates or microspheres) 100 Human albumin (macroaggregates or microspheres) 160 Lung perfusion studies 133Xe Isotonic solution 200 127Xe Lung imaging (SPECT) 99Tcm Liver and spleen Isotonic chloride 200 solution Macroaggregated Albumin (MAA) 200 Liver and spleen imaging 99Tcm Labelled colloid 80 Functional biliary system 99Tcm imaging Iminodiacetates And equivalent Agents 150 124 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Spleen imaging Red blood cells 99Tcm labeled denaturated 100 Liver imaging(SPECT) 99Tcm Labelled colloid 200 Cardiovascular First pass blood flow Studies Blood pool imaging Cardiac and vascular Imaging/probe studies 99Tcm 99Tcm 99Tcm 99Tcm 99Tcm TcO- 4 DTPA Macroaggregated globulin 400 Human albumin Complex 800 800 40 Human albumin Complex 800 Myocardial imaging/ Probe studies 99Tcm Labelled normal red blood cells Myocardial imaging 99Tcm Myocardial imaging (SPECT) Stomach, Gastrointestinal tract Stomach/salivary gland Imaging Meckel’s diverticulum Imaging Gastrointestinal bleeding 99Tcm 99Tcm 201TI 99Tcm 99Tcm 99Tcm 99Tcm 99Tcm Phosphonate and Phosphate Compounds Isonitriles TI+ chloride Phosphonate and phosphate compounds Isonitriles TcO- 4 TcO- 4 labeled colloid 400 labeled normal 125 800 600 300 100 800 600 40 400 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) red blood cells 400 Oesophageal transit and Reflux Gastric emptying 99Tcm 99Tcm 99Tcm 111In 113Inm labeled colloid non-absorbable compounds non-absorbable Compounds non-absorbable compounds non-absorbable compounds 40 40 12 12 12 Kidney, urinary system and adrenals Renal imaging 160 99Tcm Dimercaptosuccinic Acid Renal imaging/renography 99Tcm DTPS, gluconate and 100 99Tcm 123I Glucoheptonate 350 Macroaggregated globulin 3 O-iodohippuarate 20 Adrenal imaging 75Se Selenorcholesterol 8 Test testb Miscellaneous Tumour Or abscess Radio- Nuclide chemical forma Maximum usual activity per (MBq) 67Ga Citrate 300 126 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Imaging 201TI Chloride Tumour Imaging 99Tcm Dimercaptosuccinic acid 100 400 Neuroectodermal Tumour imaging 123I Meta-iodo-benzyl guanidine 400 131I Meta-iodo-benzyl guanidine 20 Lymph node Imaging 99Tcm Labelled colloid Abscess imaging 99Tcm Exametazime labeled white cell 111In 111In labeled white cells labeled platelets 80 20 20 20 a In some countries some of the compounds are considered obsolete b In some countries the typical values are lower than those indicated in the table. GUIDANCE LEVEL OF ACTIVITY FOR DISCHARGE FROM HOSPITAL GUIDANCE LEVEL FOR MAXIMUM ACTIVITY FOR PATIENTS IN THERAPY ON DISCHARGE FROM HOSPITAL Radionuclide Gold-198 Gallium-67 Iodine -123 Iodine -131 Indium-111 Phosphorus -32 Rhenium-186 Rhenium-188 Samarium-153 Strontium-89 Technetium-99m Thallium-201 Yttrium-90 Ytterbium-169 Activity (MBq) 3500 8700 6000 1200 2400 * 28,000 29,000 5000–26000 * 28,000 16,000 * 370 Dose rate at 1 m (mSv/h) 0.21 0.18 0.26 0.07 0.2 * 0.15 0.20 0.06–0.3 0.58 0.19 0.02 * No value given because of minimal exposures of the public. 127 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) __________________ FIFTH SCHEDULE ____________________ (Made under regulations 39(2)(d) and 84(2)(b)) RADIATION SYMBOLS Figure 1. Basic trefoil symbol with proportions based on a central circle of radius X. The minimum allowable size of X shall be 4 millimeters. The symbol shall be in black colour and should be placed on yellow or white background. 128 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Figure 2 Category I-WHITE label. The background colour of the label shall be white, the colour of the trefoil and the printing shall be black, and the colour of the category bar shall be red. Figure 3. Category II-YELLOW label. The background colour of the upper half of the label shall be yellow and the lower half white, the colour of the trefoil and the printing shall be black, and the colour of the category bars shall be red. 129 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Figure 4. Category III-YELLOW label. The background colour of the upper half of the label shall be yellow and the lower half white, the colour of the trefoil and the printing shall be black, and the colour of the category bars shall be red. Figure 5. Criticality safety index label. The background colour of the label shall be white, the colour of the printing shall be black. 130 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Figure 6. Placard. Minimum dimensions shall be as shown; when different dimensions are used the relative proportions must be maintained. The number ‘7’ shall not be less than 25 millimeters high. The background colour of the upper half of the placard shall be yellow and of the lower half white, the colour of the trefoil and the printing shall be black. The use of the word “RADIOACTIVE” in bottom half is optional to allow the alternative use of this placard to display the appropriate United Nations for the consignment. ________________ SIXTH SCHEDULE ________________ (Made under regulation 53(2)) HELSINKI DECLARATION HELSINKI DECLARATION (1964/96) World Medical Association Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects (document 17.C) 131 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Adopted by the 18th World Medical Assembly Helsinki, Finland, June 1964 and amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975 35th World Medical Assembly, Venice, Italy, October 1983 41st World Medical Assembly, Hong Kong, September 1989 and the 48th General Assembly, Somerset West, Republic of South Africa, October 1996. A. INTRODUCTION 1. It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfillment of this mission. 2. The Declaration of Geneva of the World Medical Association binds the physician with the words, "The Health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient." 3. The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the etiology and pathogenesis of disease. 4. In current medical practice most diagnostic, therapeutic or prophylactic procedures involve hazards. This applies especially to biomedical research. 5. Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects. 6. In the field of biomedical research a fundamental distinction must be recognised between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research, the essential object of which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research. 7. Special caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected. 8. Because it is essential that the results of laboratory experiments be applied to human beings to further scientific knowledge and to help suffering humanity, the World Medical Association has prepared the following recommendations as a guide to every physician in biomedical research involving human subjects. 132 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) They should be kept under review in the future. It must be stressed that the standards as drafted are only a guide to physicians all over the world. Physicians are not relieved from criminal, civil and ethical responsibilities under the laws of their own countries. B. BASIC PRINCIPLES 9. Biomedical research involving human subjects must conform to generally acceptable scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature. 10. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted for consideration, comment and guidance to a specially appointed committee independent of the investigator and the sponsor provided that this independent committee is in conformity with the laws and regulations of the country in which the research experiment is performed. 11. Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The design and performance of each experimental procedure involving human subjects should be transmitted for clearly formulated consideration, comment and guidance to a specially appointed committee independent of the investigator and the sponsor provided that this independent committee is in conformity with the laws and regulations of the country in which the research experiment is performed. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent. in an experimental protocol which should be 12. Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject. 13. Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interests of science and society. 14. The right of the research subject to safeguard his or her integrity must always be respected. Every precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject. 15. Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Physicians should cease any investigation if the hazards are found to outweigh the potential benefits. 133 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) 16. In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication. 17. In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The physician should then obtain the subject's freely- given informed consent, preferably in writing. 18. When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a physician who is not engaged in the investigation and who is completely independent of this official relationship. 19. In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation. 20. Whenever the minor child is in fact able to give consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian. 21. The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present Declaration are complied with. C. MEDICAL RESEARCH COMBINED WITH PROFESSIONAL CARE (Clinical Research) 22. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgement it offers hope of saving life, reestablishing health or alleviating suffering. 23. The potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods. 24. In any medical study, every patient - including those of a control group, if any - should be assured of the best proven diagnostic and therapeutic method. This does not exclude the use of inert placebo in studies where no proven diagnostic or therapeutic method exists. 134 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) 25. The refusal of the patient to participate in a study must never interfere with the physician- patient relationship. 26. If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee (I,2). 27. The physician can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient. D. NON-THERAPEUTIC BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS (Non-Clinical Biomedical Research) 28. In the purely scientific application of medical research carried out on a human being, it is the duty of the physician to remain the protector of the life and health of that person on whom biomedical research is being carried out. 29. The subject should be volunteers - either healthy persons or patients for whom the experimental design is not related to the patient's illness. 30. The investigator or the investigating team should discontinue the research if in his or their judgement it may, if continued, be harmful to the individual. 31. In research of a man, the interest of science and society should never take precedence over considerations related to the wellbeing of the subject. 135 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) ___________________ SEVENTH SCHEDULE ___________________ A. RADIOACTIVE WASTE CLASSIFICATION (Made under regulation 84(1)(a)) Six classes of waste are derived and used as the basis for the classification scheme: (1) Exempt waste (EW): Waste that meets the criteria for clearance, exemption or exclusion from Commission for radiation protection purposes (2) Very short lived waste (VSLW): Waste that can be stored for decay over a limited period of up to a few years and subsequently cleared by Commission according to arrangements approved by the for uncontrolled disposal, use or discharge. VSLW includes waste primarily containing radionuclides with very short half-lives often used for research and medical purposes. (3) Very low level waste (VLLW): Waste that does not necessarily meet the criteria of EW, but which does not need a high level of containment and isolation and, therefore, is suitable for disposal in near surface landfill type facilities with limited regulatory control. Such landfill type facilities may also contain other hazardous waste. Typical waste in this class includes soil and rubble with low levels of activity concentration. (4) Low level waste (LLW): Waste that is above clearance levels, but with limited amounts of long lived radionuclides. Such waste requires robust isolation and containment for periods of up to a few hundred years and is suitable for disposal in engineered near surface facilities.. Typical waste in this class include short lived radionuclides at higher levels of activity concentration and long lived radionuclides, but only at relatively low levels of activity concentration. (5) Intermediate level waste (ILW): Waste that, because of its content, particularly of long lived radionuclides, requires a greater degree of containment and isolation than that provided by near surface disposal. Typical waste in this class contain long lived Radioactive waste containing radionuclides with activity concentrations more than LILW-SL but which generate heat at above 2 kW/m3. 136 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) B. RADIATION DOSE LIMITATION (a) The dose limit for members of the public for doses from all planned exposure situations is an effective dose of 1 mSv in a year. This and its risk equivalent are considered criteria that are not to be exceeded both now and in the future. The dose constraint for an individual facility is 0.3 mSv in a year. (b) To comply with this dose limit, a disposal facility (considered as a single source) is so designed that the calculated dose or risk to the representative person who might be exposed in the future as a result of possible natural processes affecting the disposal facility does not exceed a dose constraint of 0.3 mSv in a year or a risk constraint of the order of 1 in 10,000 per year. Natural processes include the range of conditions anticipated over the lifetime of the facility and events that could occur with a lesser likelihood. However, extremely low probability events would be outside the scope of consideration. Risk due to the disposal facility in this context is to be understood as the probability of fatal cancer or serious hereditary effects. (c) In relation to the effects of inadvertent human intrusion after closure, if such intrusion is expected to lead to an annual dose of less than 1 mSv to those living around the site, then efforts to reduce the probability of intrusion or to limit its consequences are not warranted. (d) If human intrusion were expected to lead to a possible annual dose of more than 20 mSv to those living around the site, then alternative options for waste disposal are to be considered, for example, disposal of the waste below the surface, or separation of the radionuclide content giving rise to the higher dose. (e) If annual doses in the range 1 – 20 mSv are indicated, then reasonable efforts are warranted at the stage of development of the facility to reduce the probability of intrusion or to limit its consequences by means of optimisation of the facility’s design. (f) Similar considerations apply where the relevant thresholds for deterministic effects in organs may be exceeded. Radiation doses to people in the future can only be estimated and that uncertainties associated with these estimates will increase for periods farther into the future. Caution needs to be exercised in applying criteria for periods far into the future. Beyond such timescales, the uncertainties associated with dose estimates become so large that the criteria might no longer serve as a reasonable basis for decision-making. 137 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) __________________ EIGHTH SCHEDULE _________________ (Made under regulations 6(g), 25(1), 38(2)(a) and 60(3)(b)) A. EXPOSURE LIMITS The exposure limits for the general public are five (5) times lower than for occupational workers. This is due to the fact that such workers are normally persons who may have been trained to be aware of Radiofrequency (RF) hazards and have been medically assessed to be fit for work in RF environment. Table 1: Basic restrictions for time varying electric and magnetic fields for frequencies up to 10 GHz Type of exposure Frequency range Current density for head & trunk (mA/m2) (rms) Whole- body average SAR (W/kg) Localized SAR (head & trunk) (W/kg) Localized SAR (limbs) (W/kg) Occupational exposure Up to 1 HZ 40 1 – 4 Hz 40/f 4 Hz – 1 kHz 1 – 100 kHz 100 kHz – 10 MHz 10 MHz – 10 GHz Up to 1 Hz 10 f/100 f/100 Not determined 8 1 – 4 Hz 8/f General public exposure Not determined Not determined Not determined Not determined 0.4 Not determined Not determined Not determined Not determined 10 Not determined Not determined Not determined Not determined 20 0.4 10 20 Not determined Not determined Not determined Not determined Not determined Not determined 138 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) 4 Hz – 1 kHz 1 – 100 kHz 100 kHz – 10 MHz 10 MHz – 10 GHz 2 f/500 f/500 Not determined Not determined 0.08 Not determined Not determined 2 Not determined Not determined 4 Not determined 0.08 2 4 Note: 1. 2. Because of electrical inhomogeneity of the body, current densities should be averaged f is the frequency in hertz. 3. over a cross-section of 1 cm2 perpendicular to the current direction. For frequencies up to 100 kHz, peak current density values can be obtained by multiplying the rms value by √2(~1.414). For pulses of duration tp the equivalent frequency to apply in the basic restrictions should be calculated as f=1/(2tp). 4. For frequencies up to 100 kHz and for pulsed magnetic fields, the maximum current density associated with the pulses can be calculated from the rise/fall times and the maximum rate of change of magnetic flux density. The induced current density can then be compared with the appropriate basic restriction. 5. All SAR values are to be averaged over any 6-min period. 6. Localized SAR averaging mass is any 10g of contiguous tissue; the maximum SAR so obtained should be the value used for the estimation of exposure. 7. For pulses of duration tp the equivalent frequency to apply in the basic restrictions should be calculated as f = 1/(2tp). Additionally, for pulsed exposures in the frequency range 0.3 to 10 GHz and for localized exposure of the head, in order to limit or avoid auditory effects caused by is recommended. This is that the SAR should not exceed 10 mJ/kg for workers and 2mJ/kg for the general public, averaged over 10 g tissues. thermo elastic expansion, an additional basic restriction Table 2: Basic restrictions for power density for frequencies between 10 GHz and 300 GHz Exposure characteristics Occupational exposure General public exposure Power density (W/m2) 50 10 139 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Note: 1. Power densities are to be averaged over any 20 cm2 of exposed area and any 68/f 1.05- min period (where f is in GHz) to compensate for progressively shorter penetration depth as the frequency increases. 2. Spatial maximum power densities, averaged over 1 cm2, should not exceed 20 times the values above. Table 3: Ranges of threshold currents for indirect effects, including children, women, and men Indirect effect Touch perception Pain on finger contact Painful shock/let-go threshold Severe shock/breathing difficulty Threshold current (mA) at frequency 100kHz 25 - 40 33 - 55 112 - 224 160 - 320 1 MHz 25 - 40 28 - 50 Not determined Not determined Table 1: Reference levels for occupational and general public exposure to time-varying electric and magnetic fields (unperturbed rms values) B. REFERENCE LEVELS Type of exposure Frequency range Electric (E) field strength (V/m) Magnetic (H) field strength (A/m) B-field (µT) Equivalent plane wave power density Seq (W/m2) Occupational exposure Up to 1Hz 1 – 8Hz Not determined 20,000 8 Hz – 25Hz 20,000 0.025 – 0.82 kHz 0.82 – 65 kHz 0.065 – 1MHz 1 – 10 MHz 10 – 400 MHz 500f 610 610 610f 61 140 1.63 x 105 2 x105 Not 1.63 x 105/f2 2 x 104/f 20/f 24.4 1.6/f 1.6/f 0.16 2 x 105/f2 2.5 x 104/f 25/f 30.7 2.0/f 2.0/f 0.2 determined Not determined Not determined Not determined Not determined Not determined Not determined 10 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Type of exposure Frequency range Electric (E) field strength (V/m) Magnetic (H) field strength (A/m) B-field (µT) General public exposure 400 – 2000MHz 2 – 300 GHz Up to 1Hz 1 – 8Hz 3f1/2 137 Not determined 10,000 8 Hz – 25Hz 10,000 0.025 – 0.8 kHz 0.8 – 3 kHz 250/f 250/f 3 – 150 kHz 87 0.008f 1/2 0.01f 1/2 0.36 0.45 50 3.2 x 104 4 x 104 Not 3.2 x 104/f 2 4000/f 4 x 104/f 2 determined Not determined 5000/f Not 4/f 5 5 5/f 6.25 6.25 Equivalent plane wave power density Seq (W/m2) f/40 determined Not determined Not determined Not determined Not determined Not determined 2 0.15 – 1MHz 1 – 10 MHz 10 – 400 MHz 400 – 2000MHz 2 – 300 GHz 87 0.73/f 0.92/f 87/f 1/2 0.73/f 0.92/f 28 0.073 0.092 1.375f 1/2 0.0037f 1/2 61 0.16 0.0046f 1/2 0.20 f/200 10 Note: 1. 2. Provided that basic restrictions are met and adverse indirect effects can be excluded, f as indicated in the frequency range column. field strength values can be exceeded. 3. For frequencies between 100 kHz and 10 GHz, Seq, E2, H2, and B2 are to be averaged over any 6-min period. 4. For peak values at frequencies up to 100 kHz see Appendix 7. 5. Between 100 kHz and 10 MHz, peak values for the field strengths are obtained by interpolation from the 1.5-fold peak at 100 kHz to the 32-fold peak at 10 MHz. For frequencies exceeding 10 MHz it is suggested that the peak equivalent plane wave power density, as averaged over the pulse width, does not exceed 1,000 times the Seq 141 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) restrictions, or that the field strength does not exceed 32 times the field strength exposure levels given in the table. 6. For frequencies exceeding 10 GHz, Seq, E2, H2, and B2 are to be averaged over any 68/f 1.05-min period (f in GHz). 7. No E-field value is provided for frequencies <1 Hz, which are effectively static electric fields. Electric shock from low impedance sources is prevented by established electrical safety procedures for such equipment. Perception of surface electric charges will not occur at field strengths less than 25 kV/m. Spark discharges causing stress or annoyance should be avoided. C. GUIDELINES FOR LIMITING EXPOSURE TO TIME-VARYING ELECTRIC AND MAGNETIC FIELDS (1Hz – 100 kHz) Table 1: Basic Restrictions (General Public) for human exposure to time-varying electric and magnetic fields Guidelines for limiting exposure to time-varying electric and magnetic fields (1Hz – 100 kHz) Magnetic Induction (Magnetic fields) field actually required: 606 µT Electric fields 20 mV/m in the head (brain & retina) 400 mV/m in the whole body Guidelines for limiting exposure to time-varying electric and magnetic fields (up to 300 GHz) Specific Absorption Rate (SAR) Electric fields 20 mV/m in the head (brain & retina) 400 mV/m in the whole body Table 2: Reference Levels (General Public) for human exposure to time-varying electric and magnetic fields Guidelines for limiting exposure to time-varying electric and magnetic fields (1Hz – 100 kHz) Magnetic Induction (Magnetic fields) ICNIRP reference level: 200 µT (160 A/m) field actually required: 606 µT Guidelines for limiting exposure to time-varying electric and magnetic fields (100 kHz - 300 GHz) Magnetic Induction (Magnetic fields) Electric fields ICNIRP reference level: 5 kV/m field actually required: 9.9 kV/m Electric fields Table 3: Basic Restrictions (Occupational) for human exposure to time-varying electric and magnetic fields Guidelines for limiting exposure to time-varying electric and magnetic fields (1Hz – 100 kHz) 142 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Magnetic Induction (Magnetic fields) field actually required: 3.03 mT Electric fields 100 mV/m in the head (brain & retina) 800 mV/m in the whole body Guidelines for limiting exposure to time-varying electric and magnetic fields (up to 300 GHz) Specific Absorption Rate (SAR) 0.4 W/kg Electric fields Table 4: Reference Levels (Occupational) for human exposure to time-varying electric and magnetic fields Guidelines for limiting exposure to time-varying electric and magnetic fields (1Hz – 100 kHz) Magnetic Induction (Magnetic fields) ICNIRP reference level: 1 mT (800 A/m) field actually required: 3.03 mT Guidelines for limiting exposure to time-varying electric and magnetic fields (up to 300 GHz) Magnetic Induction (Magnetic fields) Electric fields ICNIRP reference level: 10 kV/m field actually required: 24.2 kV/m Electric fields Note: Basic restrictions for 50 Hz fields are the values of the electric field strength considered as acceptable for people's well-being. D. MAXIMUM PERMISSIBLE EXPOSURE The maximum permissible exposure (MPE) emission limits for laser radiation for Occupational Frequency Range (MHz) 0.3-3.0 3.0-30 30-300 300-1500 1500-100,000 Electric Field Strength (V/m) 614 842/f 61.4 - - Magnetic Field Strength (A/m) 1.63 4.89/f 0.163 - - Power Density (mW/cm2) Averaging Time (minutes) 100 † 900/f2 † 1.0 f/300 5 6 6 6 6 6 The maximum permissible exposure (MPE) emission limits for laser radiation for the General Public 143 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Frequency Range (MHz) 0.3-3.0 3.0-30 30-300 300-1500 1500-100,000 Electric Field Strength (V/m) 614 842/f 27.5 - - Magnetic Field Strength (A/m) 1.63 2.19/f 0.073 - - Power Density (mW/cm2) Averaging Time (minutes) 100 † 180/f2 † 0.2 f/500 1.0 30 30 30 30 30 f = frequency in MHz † = plane-wave equivalent power density (see note) Note: Equivalent far field strength that would have the E-field or H-field components calculated or measured. Equivalent far field density for near and far fields can be calculated using Power Density = |Etotal|2/3770 mW/cm2 or Power Density = |Htotal|2/37.7 mW/cm2 E. EXPOSURE LIMITS VALUES (ELVs) AND ESTIMATED EXPOSURES IN MRI Table 1: Exposure Limit Values (ELVs) and Estimated Exposures in MRI Estimated maximum occupational exposure in MRI 3 T (clinical) 9.4 T (research) 200 – 400 mA/m2 (Central Nervous System); limit exceed 0.5 – 1.0m from magnet if moving at 1m/s >200 mA/m2 (Central Nervous System); limit exceeded ≈ 1m from end of scanner bore. Not exceeded in normal circumstances Field Frequency ELV Static magnetic field (always present for most scanners) Switched gradients (present only during imaging) RF (present only during imaging) 0 Hz < 1 Hz (typical) (generated by movement of subject) 1 kHz (typical) 10 – 100s MHz None (action value 200mT) Current density 40mA/m2 head & trunk Current density 10mA/m2 head and trunk Specific absorption rate (SAR) § 0.4W/kg whole body § 10 W/kg head & trunk § 20W/kg limbs; all SAR values 144 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) averaged over 6 min, localized SAR averaged over 10g tissue. Note 1: For whole-body exposures, no adverse health effects are expected if the increase in body core temperature does not exceed 1°C. In the case of infants and persons with cardio circulatory impairment, the temperature increase should not exceed 0.5°C. With regard to localized heating, it seems reasonable to assume that adverse effects will be avoided with a reasonable certainty if temperatures in localized regions of the head are less than 38°C, of the trunk less than 39°C, and in the limbs less than 40°C. Note 2: For the purposes of these Regulations Adverse health effect means a biological effect that has a detrimental effect on mental, physical and/ or general well-being of exposed people, either in the short-term or long term. Table 2: Basic restrictions for body temperature rise and partial-body temperatures Operating mode Normal Controlled Restricted Rise of body core temperature (oC) 0.5 1 >1 Spatially localized temperature limits Head (oC) Trunk (oC) Extremities (oC) 38 38 >38 39 39 >39 40 40 >40 Table 3: SAR levels valid at environmental temperatures below 24oC Local SAR (averaged over 10g tissue) Head Head Trunk Extremities Partial-body SAR (W/kg) Averaging time: 6 minutes Whole body SAR (W/kg) Whole body Any, except head 2 – 10a 4 – 10a >(4 – 10a) 145 Body region Operating mode Normal Controlled Restricted Short term SAR Note: 2 4 >4 The SAR limit over any 10s period should not exceed 3 times the corresponding average SAR limit 20 20 >20 10 10 >10 3 3 >3 10b 10b 10b Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) § a Partial-body SARs scale dynamically with the ratio r between the patient mass exposed and the total patient mass: ü normal operating mode: SAR = (10–8 . r) W/kg ü controlled operating mode: SAR = (10–6 . r) W/kg § The exposed patient mass and the actual SAR levels are calculated by the SAR monitor implemented in the MR system for each sequence and compared to the SAR limits. b In cases where the eye is in the field of a small local coil used for RF transmission, care should be taken to ensure that the temperature rise is limited to 1°C EXPOSURE LIMITS TO AIRBORNE ULTRASOUND § F. Frequency (kHz) 20 25 31.5 40 50 Sound pressure level (dB) 75 110 110 110 110 Note: The majority of the wave energy from airborne ultrasound is deflected by the skin rather than absorbed and therefore the effects on the skin can be considered negligible under ‘normal’ exposure conditions. There is some evidence however, to suggest that slight heating of the skin can occur when we are exposed to high sound pressure levels (SPLs) of between 140 -150 dB at ultrasonic frequencies. 146 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) __________________ NINTH SCHEDULE ___________________ (Made under regulation 7(3)(d)) Radiation generators emitting non-ionizing radiation i. Devices emitting electromagnetic radiation in the UV, IR and RF, and laser source in these spectral regions, will be exempted from the regulations provided that they comply with Tanzania standard for free use. The last condition applies only if the said standards relate to the radiation emitted. ii. Devices that do not comply with Tanzania standards( or even if they comply, but the specific standards does not relate to radiation hazards) will be exempted from the present regulations, provided they comply with the following: a. Ultra violet (UV) radiation: any device emitting electromagnetic radiate in the spectral region 180-400 nm will be exempted from the present regulations, provided that the weighted power density emitted (as measured at a distance of 5 cm from any accessible point on the device ) does not exceed 3X 10-8 W/cm2 *A, where A is weighting factor given in table 1 below: Table 1: Weighting factor A Wavelength (nm) 180 200 210 230 240 250 270 300 305 313 315 325 350 400 147 A 0.012 0.030 0.075 0.190 0.300 0.430 1.000 0.300 0.060 0.006 0.003 0.005 0.002 0.00003 Atomic Energy (Protection From Ionizing and Non-Ionizing Radiation) GN. NO. 840 (Contd) Notes to use of Table 1: 1) Use linear interpolation for wavelength of intermediate values. 2) For devices emitting at more than one wavelength, the weighted contributions from each wavelength should be summed up. Alternatively, measurements can be conducted by instruments with a spectral response which is tailored in accordance with the weighting factors of Table 1. b. Infra red (IR) radiation: Any device emitting in spectral range 780nm -1mm, with a power density lower than 10Mw/cm2, as measured at a distance of 5cm from any accessible point on the device, shall be exempted from the present regulations. c. Radiation frequencies (RF): Any device emitting RF radiation, in the spectral range 1mm-1000km, shall be exempted from the present regulations, provided that its power density, as measured at a distance of 5cm from any accessible point on the device, complies with the following: In frequency range: 3 kHz-450 MHz-7W In frequency range: 0.4 GHz-1.5 GHz-7W- 7.(0.45/f, where f is the frequency in GHz. In frequency range: 1.5 GHz-300 GHz-2.1W Dodoma, 27th October, 2023 ADOLF F. MKENDA Minister of Education, Science, and Technology 148