STATUTORY INSTRUMENTS

SUPPLEMENT No. 4                                                                             27th January, 2012

STATUTORY INSTRUMENTS SUPPLEMENT

to The Uganda Gazette No. 5 Volume CVdated 27th January, 2012 Printed by UPPC, Entebbe, by Order of the Government.

STATUTORY INSTRUMENTS

2012 No. 4.

THE ATOMIC ENERGY REGULATIONS, 2012

ARRANGEMENT OF REGULATIONS

Part I—Preliminary

Regulation

1. Title.
2. Purpose.
3. Application.
4. Interpretation.
5. Exposures.
6. Exclusions.
7. Persons responsible for application of regulation.
8. Right to enter and inspect.
9. Incidents and accidents.
10. Applicability of other regulations and requirement.
11. Enforcement.

Part II—Administrative Requirements.

12. General obligations.
13. Requirements for notifications.
14. Exemptions of practices and sources.
15. Application for authorisation.
16. Modifications.
17. Grounds for grant and rejection of application.
18. Cessation or suspension of an authorised activity or operation of an authorised facility.

Regulation

19. Authorisation to import, export or transport.
20. Registration of qualified experts.
21. Responsibilities of authorised person.
22. Clearance.

Part III—Radiation Protection Performance Requirements.

23. Justification of practice.
24. Dose limits.
25. Optimisation of protection and safety.
26. Dose constraints.

Part IV—Management Requirements.

27. Safety culture.
28. Quality assurance.
29. Human factor.
30. Radiation safety officer.
31. Radiation Safety Committee.

Part V—Verification of Protection And Safety.

32. Safety and security assessments.
33. Monitoring and verification of compliance.
34. Records.

Part VI—Occupational Exposure Protection.

35. General responsibilities of authorised persons and employers.
36. Conditions of services.
37. Classification of areas.
38. Local rules and supervision.
39. Protection of employees.
40. Exposure assessment.
41. Monitoring of workplace.
42. Health surveillance.
43. Records of worker exposure.
44. Investigation of accidental occupational exposures.
45. Special circumstances.

Part VII—Medical Exposure Protection.

46. General responsibilities under medical exposure.
47. Justification of medical exposure.
48. Optimisation of protection for medical exposures.
49. Calibration, clinical dosimetry and quality assurance for medical exposures.
50. Dose constraints.
51. Guidance levels.
52. Maximum activity for patients in therapy on discharge from hospital.
53. Investigation of accidental medical exposure.
54. Medical dosimetry records.

Part VIII—Public Exposure Protection.

55. General responsibilities for authorised person for public exposure.
56. Control of visitors.
57. Sources of external irradiation.
58. Radioactive contamination in enclosed spaces.
59. Discharge of radioactive materials.
60. Monitoring of public exposure.
61. Consumer products.

Part IX—Requirements for the Safety And Security of Source.

62. General responsibilities of authorised person for safety and security of source.
63. Storage of radiation sources.
64. Design and procurement of source.
65. Accountability and security of sources.
66. Feedback of operating experience.

Part X—Requirement For Emergency Intervention.

67. Responsibilities of authorised person in an emergency.
68. Authorised person emergency response planning requirements.
69. Implementation of intervention.
70. Protection of workers undertaking an intervention.

Part XI—Management of Radioactive Wastes.

71. Application of radioactive waste management requirements.
72. Radioactive waste classification.
73. Management of radioactive waste.
74. Authorisation to manage radioactive waste.
75. Control of radioactive waste generation.
76. Segregation, collection and characterisation of radioactive waste.
77. Treatment and conditioning of radioactive waste.
78. Discharge or release of radioactive substances to the environment.
79. Disposal of radioactive waste.
80. Transport of radioactive waste.
81. Waste storage.
82. Recycle and reuse of radioactive material.
83. Return of sealed sources to manufacturer.
84. Quality assurance programmes.
85. Physical protection.
86. Records and reports.

Part XII—Transport of Radioactive Materials.

87. Exemptions.
88. Application of regulations.
89. Exempt consignments.
90. Material characterisation.
91. Unpackaged shipments.
92. Packaging.
93. Mixed content.
94. Contamination.
95. Maximum radiation levels.
96. Transport index.
97. Marking.
98. Labeling requirements.
99. Information required on labels.
100. Loading and segregation.
101. Placarding.
102. Transport documents.
103. Storage and dispatch.
104. Carriage.
105. Sender to receive acknowledgement receipt of materials.
106. Monitoring arrival of shipment.
107. Investigation of shipment and report to the Council.

Part XIII—Miscellaneous.

108. Decontamination.
109. Decommissioning and disposal of radioactive waste.
110. Radioactive waste from mining and milling operation.
111. Notification of Council.
112. Security of package.
113. General penalty.
114. Repeal.

SCHEDULES

Schedule 1	- Authorisation forms.
Schedule 2	- Exemption levels.
Schedule 3	- Dose limits for exposures incurred from practices.
Schedule 4	- Medical exposure-design and operational requirements.
Schedule 5	- Guidance levels of dose, dose rate and activity for medical
	exposure.
Schedule 6	- Fees and charges.
Schedule 7	- Radiation symbols and transport packages.
Schedule 8	- Helsinki Declaration 1964.
Schedule 9	- Radioactive waste classification.
Schedule 10	- Categorisation of sources and renewal of authorisation.
Schedule 11	- Activity limits, material restriction.
Schedule 12	- Declaration of contents of consignment.
Schedule 13	- Formulae.
Schedule 14	- Currency points.

STATUTORY INSTRUMENTS

2012 No. 4. The Atomic Energy Regulations, 2012.

(Under section 73 of the Atomic Energy Act, 2008, Act No. 24 of2008).

In exercise of the powers conferred upon the Atomic Energy Council by

section 73 of the Atomic Energy Act, 2008, these Regulations are made

this 24th day of November, 2011.

Part I—Preliminary.

1. Title.

These Regulations may be cited as the Atomic Energy Regulations,

2012.

2. Purpose.

The purpose of these Regulations is—

1. to specify the minimum requirements for the protection of individuals, society and environment from the dangers resulting from ionising radiation;
2. to provide for the safety and security of radiation sources, hereinafter referred to as radiation safety, protection and security; and
3. to revoke and replace the Atomic Energy (Ionising Radiation Protection) Standards Regulations (S.I. 143 - 1).

3. Application.

1. These Regulations apply to—

1. the introduction, conduct, discontinuance, or cessation of a practice;
2. to the design, manufacture, construction or assembly, acquisition, import or export, distribution, selling, loaning or hiring, locating, commissioning, processing, production, possession, use and operation, maintenance or repair, transfer or decommissioning, disassembly, transport of all situations involving exposure or the potential for exposure to ionising radiation, storage; and
3. disposal of a source within a practice unless exposure from the source is excluded or exempted in accordance with these Regulations.

2. The sources within any practice to which the requirements for practice of these Regulations apply include—

1. radioactive substances and devices that contain radioactive substances or produce ionising radiation, including consumer products, sealed sources, unsealed sources, and ionising radiation generators, including mobile radiography equipment;
2. installations and facilities containing radioactive substances or devices which are used for industrial, medical, agricultural, research, power generation and education purposes; and
3. any other source specified by the Council.

4. Interpretation.

In these Regulations, unless the context otherwise requires—

“accident” means any unintended event including an operating error, equipment failures or other mishap, the consequences or potential consequences of which is not negligible from the point of view of protection or safety;

“Act” means the Atomic Energy Act, 2008;

“administer ionising radiation” means the intentional act of subjecting ionising radiation whether internal or external to a person for the purpose of medical treatment or diagnosis by a qualified expert;

“article” means an item or thing or equipment associated with the emission of radiation;

“atomic energy” means ionising radiation emitted or energy released as a result of electronic or nuclear transitions in an atom;

“authorisation” means permission granted in writing by the council to a person who has submitted an application to carry out a practice or any other action described in the general obligations for practices under the Act and includes a certificate of registration, licence or permit granted by the Council under section 37 of the Act;

“authorised officer” means an officer appointed or authorised to perform any functions in relation to the enforcement of these Regulations and includes a police officer;

“authorised person” means a person issued an authorisation under section 37 of the Act;

“certificate of registration” means a certificate issued under section 51 of the Act;

“chairperson” means the chairperson of the council;

“clearance” means the removal of radioactive materials or radioactive objects within authorised practices from any further control by the council;

“continuous exposure” means external exposure where the source of radiation subjects the body or any critical organ to prolonged exposure or internal exposure due to continuous intake;

“Council” means the Atomic Energy Council established by section 4 of the Act;

“critical group” means a group of members of the public which is reasonably homogeneous with respect to its exposure for a given radiation source and given exposure pathways and its typical of individuals receiving the highest effective dose (as applicable) by the given exposure pathway from the given source;

“currency point” means the value assigned to a currency point in Schedule 14;

“decommissioning” means administrative and technical action taken to allow removal of some or all of the regulatory controls from a nuclear facility except for a repository, which is closed and not decommissioned; and it includes decontamination, dismantling and removal of radioactive materials, waste, components and structures;

“disease” includes injury and bodily or mental deficiency or abnormality;

“disposal” in relation to waste, includes its removal, deposit or destruction, its discharge, whether into water or into air or into a sewer or drain or otherwise, its burial whether underground or otherwise and “dispose of” shall be construed accordingly;

“dose” means a measure of the radiation received or absorbed by a target;

“dose constraint” means a prospective and source related restriction on the individual dose delivered by the source which serves as a bound or limit in the optimisation of protection and safety of the source;

“dose equivalent” means a quantity used by the International Commission on Radiation Units and measurements (ICRU) in defining the operational quantities ambient dose equivalent, directional dose equivalent and personal dose equivalent;

“dose limit” means the value of the effective dose or the equivalent dose to an individual that is not to be exceeded in activities of controlled practices;

“effective dose” means a summation of the tissue equivalent doses, each multiplied by the appropriate tissue weighting factor;

“emergency plan” means a set of procedures to be implemented in the event of a radiation accident;

“equivalent dose” means the measure of the radiation dose to the tissue where an attempt has been made to allow for the different relative biological effects of different types of ionising radiation; (The quantity H_TR defined as H_TR = D_tR.Wr where D_Tr is the absorbed dose delivered by radiation type R averaged over a tissue or organ T and Wr is the radiation weighting factor for radiation type R);

“ethical review committee” means a committee of independent persons to advise on the conditions of exposure and the dose constraints to be applied to the medical exposure of individuals exposed for biomedical research purposes when there is no direct benefit to the exposed individual;

“exclude” means the exclusion from regulation of any exposure whose magnitude or likelihood is essentially unamenable to control through the requirements of the standards;

“exclusive use” means that a single consignor has sole use of the conveyance or large freight container such that all loading and unloading is carried out in accordance with the directions of the consignor or consignee;

“exempt” means the determination by the Council that a source or practice need not to be subject to some or all aspects of regulatory control on the basis that the exposure, including potential exposure due to source or practice is too small to warrant the application of those aspects or that this is the optimum option for protection irrespective of the actual level of dose or risks;

“exposure” means the act or condition of being subjected to irradiation;

“external exposure” means the act or condition of being subjected to irradiation by a source outside the body;

“facility” means any assembly of devices, equipment, structures or natural features whether simple or complex which serves some purpose or performs some function, in the course of which radiation is, or is capable of being emitted;

“IAEA” means the International Atomic Energy Agency;

“incident” means any unintended event which under slightly different circumstances, could have resulted in harm to people, damage to property, or loss of process;

“internal exposure” means the act or condition of being subjected to irradiation by a source inside the body;

“intervention” means any action intended to reduce or avert exposure, or the likelihood of exposure to sources which are not part of a controlled practice or which are out of control as a consequence of an accident;

“investigation level” means the value of a quantity such as effective dose, intake or contamination per unit area or volume at or above which an investigation should be conducted;

“ionising radiation” means electromagnetic or corpuscular radiation, consisting of photons or particles capable of producing ions, directly or indirectly, in its passage through matter;

“licence” means an authorisation granted by the Council on the basis of a safety assessment and accompanied by specific requirements and conditions to be complied with by an authorised person;

“medical practitioner” means an individual who—

1. has been accredited through appropriate national procedures as a health professional;
2. fulfils the national requirements for training and experience of prescribing procedures involving medical exposure; and
3. is a registrant or an authorised person, or a worker who has been designated by a registered or licenced employer for the purpose of prescribing procedures involving medical exposure;

“Minister” means the minister responsible for atomic energy and radiation protection;

“notification” means a document submitted to the Council by a person to notify requirements in such a manner as provided for in regulation 13(1) and 13(2);

“nuclear installation” means a nuclear fuel fabrication plant, a nuclear reactor, including critical and sub critical assemblies, research reactor, nuclear power plant, spent fuel storage facility, enrichment plant or reprocessing facility;

“nuclear safety” means the condition and ability of a nuclear installation and its servicing personnel to prevent the uncontrolled development of a fission chain reaction or an inadmissible release of radioactive substances or ionising radiation into the environment, and to reduce the consequences of accidents;

“physical protection” means methods or ways of preventing unauthorised access or activities to a facility through a system of mechanical, technical and organisational measures;

“plant” means any machinery, facility or installation, whether affixed to land or not, but does not include anything comprised or to be comprised in any means of transport, whether by land, water or air;

“practice” means any human activity that introduces additional sources of exposure pathways or extends exposure to additional people or modifies the network of exposure pathways from existing sources, so as to increase the exposure or the likelihood of exposure of people or the number of people exposed;

“premises” means any land, whether developed or not, including any place underground and any land covered by water;

“qualified expert” means an individual who by virtue of certification by appropriate boards or societies, professional licence or academic qualification and experience, is duly recognised by the Council as having expertise in a relevant field of specialisation e.g. medical physics, radiation protection, occupational health, quality assurance or any relevant engineering or safety specialty;

“radiation” means ionising radiation;

“radiation device” means equipment capable of generating ionising radiation when energized;

“radiation protection” means a system of technical and organisational measures to reduce or limit exposure of people and the environment from ionising radiation;

“Radiation Protection Officer” means any person appointed under section 19 of the Act;

“radiation safety” means measures intended to minimise the likelihood of accidents with radiation sources and, should such an accident occur, to mitigate its consequences;

“Radiation Safety Officer” means an individual who is competent in radiation protection matters as provided for by section 36 of the Act, to oversee the implementation of the requirements of these Regulations and is recognised by the Council;

“radioactive material” means any matter or substance containing one or more radionuclides, the activity or concentration of which is sufficiently intense to entail a significant risk or disability or disease to any person or organ on exposure, whether external or internal, and whether continuous or total;

“radioactive waste” means material, whatever its physical form, remaining from practices or interventions and for which no further use is foreseen—

1. that contains or is contaminated with radioactive substances and has an activity or activity concentration higher than the level for clearance from regulatory requirements; and
2. exposure to which is not excluded from the Standards;

“recording level” means a level of dose, exposure or intake specified by the Council at or above which values of dose exposure or intake received by workers are to be entered in their individual exposure record;

“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;

“sealed source” means a source consisting of radioactive material firmly incorporated in a solid of effectively inactive materials, or sealed in an inactive container of a strength sufficient to prevent, under normal conditions of use, any dispersion of radioactive material and any possibility of contamination;

“security” means measures to prevent unauthorised access or damage to, and loss, theft or unauthorised transfer of radioactive materials;

“source” means an apparatus, device, material or anything capable of emitting radiation;

“special form radioactive material” means either an indispersible solid radioactive material or a sealed capsule containing radioactive material that has a very high degree of physical integrity so that if the material were released from the package in an accident, while there might be a high radiation hazard, it is unlikely that there would be any contamination hazard;

“Standards” means the International Basic Safety Standards for Protection against ionising radiation and for the safety of radiation sources issued by the IAEA;

“Transport Index (TI)” means a number that is assigned to transport package, over pack, freight container or conveyance, which is used to provide control over groups of packages for the purposes of minimising radiation risks;

“unsealed sources or open sources” means a source that does not meet the definition of a sealed source;

“user” means a person or body of persons or institution authorised to use ionising radiation under these Regulations or the Act;

“worker” means any person who works, whether full time, part time or temporarily, for an employer and who has recognized rights and duties in relation to occupational radiation protection.

5. Exposures.

The exposures to which these Regulations apply include—

1. any occupational exposure;
2. medical exposure; or
3. public exposure,

due to any relevant practice or source within a practice, including both

normal exposures and potential exposures.

6. Exclusions.

1. The following exposures are excluded from the requirements of these Regulations—

1. exposures from natural radioactivity in the body; and
2. exposures from cosmic radiation and unmodified concentrations of natural radionuclides in raw materials.

2. Any other sources that are essentially unamenable to control as may be determined by the Council.

7. Persons responsible for application of Regulations.

1. The Council shall be responsible for the enforcement of these Regulations.
2. The persons that have principle responsibility for the application and compliance with these Regulations include—

1. authorised persons; and
2. employers.

3. The general responsibilities of the parties referred to in subregulation (2) include—

1. to establish radiation safety objectives in conformity with the relevant requirements of these Regulations; and
2. to develop, implement and document a radiation safety programme commensurate with the nature and extent of the risks associated with the practice and interventions under their responsibility sufficient to ensure compliance with the requirements of these Regulations.

4. The radiation safety programme shall include the following actions—

1. to determine and keep continually under review the measures needed to achieve the radiation safety objectives;
2. to ensure that the resources needed for their implementation are provided regularly;
3. to verify that the radiation safety objectives are being achieved;
4. to identify and prevent, or promptly correct, any failures or shortcomings in the radiation safety measures;
5. to facilitate consultation and cooperation between all relevant parties with respect to radiation protection, safety and security; and
6. to keep appropriate records regarding the discharge of their responsibilities.

5. Persons that have subsidiary responsibility for the application of these Regulations include—

(a)	suppliers, clearing and forwarding agents;
(b)	workers;
(c)	radiation safety officers;
(d)	the army, police and customs officials;
(e)	medical practitioners;
(f)	health professionals;
(g)	qualified experts;
(h)	ethical review committees; and
(i)	any other party specially delegated by a party referred to in regulation 7(2).

 

8. Right to enter and inspect.

A Radiation Protection Officer or other authorised officer in the course of his or her duties shall have the rights and powers provided for by section 21 of the Act.

9. Incidents and accidents.

1. In the event of an incident or accident, an authorised person or an employer shall—

1. investigate the incident or accident and its causes, circumstances and consequences;
2. take appropriate action to remedy the circumstance and prevent a recurrence of a similar situation;
3. communicate to the Council the incident or accident, its causes, its circumstances, consequences, any loss of life and serious personal injury caused by the accident or incident, and recommend the corrective or preventive actions taken or to be taken; and
4. take any other action necessary under these Regulations.

2. The communication of an incident or accident to the Council shall be made as soon as possible, but in any case within forty eight hours after an emergency exposure situation has developed or is developing.
3. Failure to take corrective or preventive actions within a reasonable time in accordance with these Regulations shall be ground for modifying, suspending or withdrawing any authorisation.
4. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 200 currency points or imprisonment for a term not exceeding 4 years or both.

10. Applicability of other regulations and requirements.

1. Nothing in these Regulations shall be construed as relieving employers from complying with applicable laws and regulations governing workplace hazards, including radiation hazards from natural sources, which are unconnected with the work.
2. Nothing in these Regulations shall be construed as restricting any action that may otherwise be necessary for protection and safety.

11. Enforcement.

1. The Council may revoke, suspend or modify an authorisation to use a source, or prohibit the possession of a source, upon finding an undue threat to health, safety and security or non-compliance with applicable requirements.
2. The Council may, upon finding willful violations or attempted violations of these Regulations or requirements, institute legal proceedings.
3. The Council may as appropriate impose fines or direct closure or undertake an action for locking the premises for non-compliance with these Regulations and any other requirements commensurate with the nature of violation.

Part II—Administrative Requirements.

12. General obligations.

1. A person shall not engage in activities, which involve practices or sources within practices as specified in regulation 3 unless he or she has complied with the requirements of these Regulations.
2. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 200 currency points or imprisonment for a term not exceeding 4 years or both.

13. Requirements for notification.

1. All practices and sources shall require notification as specified in Form 1A or 1B, Schedule 1.
2. Subject to regulation 15, any person intending to initiate a practice or to possess a radiation source, shall submit a prior notification to the Council, and notices of his or her intention shall be handled in accordance with section 34 of the Act.
3. A person shall after giving notification as specified in subregulation (1) and (2), apply to the Council for authorisation as specified in regulation 15.
4. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

14. Exemption of practices and sources.

1. Practices and sources within a practice may be exempted from the requirements of these Regulations provided that they comply with the exemption levels specified in Schedule 2.
2. Exemptions shall not be granted for practices not regarded as justified by regulation 23.
3. Practices and sources within a practice are further exempted from the requirements of these Regulations, including requirements for authorisation specified in section 33 of the Act.

15. Application for authorisation.

1. Except as provided for by regulation 14(3) and regulation 13, a person who intends to engage in a practice or possess a radiation source referred to in regulation 3 shall apply to the Council for an authorisation specified in Form 2A, 2B, 3, 4, 5, 6 and 7, Schedule 1.
2. An application for an authorisation shall be submitted to the Council and shall contain—

1. the legal status and technical competence of the applicant;
2. a technical description of the practice to be carried out;
3. the planned time of commencement and completion of the construction of installations relating to the practice;
4. the name and qualifications of at least one person designated as a radiation safety officer for purposes of the practice;
5. an evaluation of the nature, magnitude and likelihood of the exposures attributed to the practice and source within the practice;
6. reports and studies undertaken, including an environmental impact assessment and a safety assessment of the proposed practice;
7. a determination of the characteristics and activities of any radioactive material to be discharged to the environment with an assessment of the resulting doses to the relevant critical group;
8. in case of a source meant for medical exposure the qualifications in radiation protection of the medical practitioners who are to be designated by name or by qualification credentials in the authorisation as the only individuals permitted to administer medical exposure by means of the authorised source;
9. necessary steps to be taken for the protection and safety of workers, members of the public and where applicable, patients;

(j) the impact of the proposed practice on public and private interests, including the interests of affected landowners and holders of other rights and possible mitigation measures;

(k) an emergency response plan for the proposed practice;

• consents and permits required under any other law;

(m) the fees as specified in Schedule 6; and

(n) any further information that the Council may require.

3. The Council shall, within thirty days after receipt of an application for an authorisation, confirm in writing to the applicant, that the application is complete in all aspects; and where the application is not complete, shall request the applicant to re-submit the application.
4. The Council shall process every application for an authorisation expeditiously and in any case, not later than ninety days after receipt of the application.
5. Where an application refers to an industrial irradiation installation, nuclear installation, an installation processing radioactive substances, a medical or industrial radiography facility, or for any use of source, which the Council has not designated as appropriate for registration, the authorisation shall take the form of a licence.
6. An authorisation to possess or use sources and radiation premises specified in Form 3, Schedule 1 shall be granted for the duration specified in Table 2, Schedule 10 and may be renewed by the Council after fulfillment of the safety requirements.

(9) A person shall submit his or her application for a renewal of an authorisation three months prior to the expiry date.

16. Modifications.

1. All modifications, change of ownership, transfer, sell, lease or loan of any apparatus, article, plant, installation or other material or substance shall require authorisation.
2. A person applying for an authorisation to modify any apparatus, article, plant, installation or other material or substance shall—

1. submit to the Council relevant information necessary to support the application as specified in Form 6, Schedule 1;
2. pay a license fee as specified in Schedule 6.

3. Any person applying for an authorisation to transfer, sell, lease or loan of any apparatus, article, plant, installation or other material or substance shall—

1. submit to the Council relevant information necessary to support the application as specified in Form 7, Schedule 1;
2. state how the specific security measures required by these Regulations will be met;
3. state a final disposal solution for generated radioactive waste and disused sealed sources; and
4. pay a license fee as specified in Schedule 6.

4. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 50 currency points or imprisonment for a term not exceeding 2 years or both.

17. Grounds for grant and rejection of application.

1. The Council shall, in granting or rejecting an application for an authorisation, take into consideration, as far as is adequate for the practice applied for—

1. the legal status of the applicant;
2. the impact of the practice on the social, cultural and recreational life of the community;
3. the need to protect the environment and to conserve natural resources;
4. the land use and siting of the practice;
5. the ability of the applicant to operate in a manner designated to protect the health and safety of users, workers, beneficiaries and other members of the public who would be affected by the practice; and ensure the security of radiation sources and installations; and
6. public and private interests affected by the practice.

2. The Council may, grant an authorisation subject to the conditions set out under subregulation (1).
3. The Council shall, where it refuses to grant an authorisation, give the applicant a statement of its reasons for the refusal within thirty days after the decision.
4. A person aggrieved by the decision of the Council under subregulation (3) may appeal to the High Court.
5. Nothing under these Regulations shall prevent the holder of an authorisation who has fulfilled all the obligations under that authorisation from applying for and obtaining any other authorisation under these Regulations.

18. Cessation or suspension of an authorised activity or operation

of an authorised facility.

1. A person who holds an authorisation shall not, without prior written approval or instruction of the Council—

1. cease or suspend the authorised activity or the operation of an authorised facility; or
2. decommission or abandon an installation or waste management system.

2. An authorised person shall decontaminate his or her premises to the justification of the Council before vacating the premises.
3. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

19. Authorisation to import, export or transport.

1. A person who applies for an authorisation to import, export or transport any apparatus, article, plant, installation or other material or substance which is a source or intended to be used for the purposes of emission of radiation, shall—

1. submit to the Council information necessary to support his or her application as specified in Form 4 and Form 8, Schedule 1;
2. pay a licence fee as specified in Schedule 6.

2. An authorisation to import, export or transport a radiation source is valid six months from the date of grant of the authorisation.
3. The Council shall, in granting or rejecting an application for an authorisation under subregulation (1), take into consideration the matters specified in regulation 17.

20. Registration of experts.

1. An expert who intends to carry out a practice that involves the administering of ionising radiation on any person for the purposes of diagnosing or treating a disease shall apply for an authorisation specified in Form 2B, Schedule 1.
2. The expert shall in addition—

1. submit to the Council relevant information necessary to support

his or her application as specified in Form 5, Schedule 1;

2. pay the authorisation application fee as specified in Schedule 6.

3. An authorisation to administer ionising radiation to person shall be valid for five years from the date of the grant of the licence.
4. An authorisation for administering ionising radiation to persons may be suspended or revoked in case of violation of radiation protection and safety protocols or non-compliance with the requirements prescribed by the Council.

21. Responsibilities of authorised persons.

1. An authorised person shall establish and implement the technical and organisational measures required for ensuring protection and safety for the practices and sources for which the authorisation is made and for compliance with all applicable requirements of these Regulations.
2. An authorised person may appoint and identify other persons to carry out actions and tasks related to the responsibilities under subregulation (1), but shall retain the responsibility for the actions and tasks themselves.
3. An authorised person shall notify the Council of his or her intention to introduce modifications to any practice or source and radiation premises for which they are authorised whenever the modifications could have significant implications for protection or safety, and shall not carry out any such modifications unless specifically authorised by the Council.
4. An authorised person shall ensure that only workers designated in the authorised application form by name or qualification credentials are given key assignments related to protection and safety, or are assigned tasks involving operation or handling of radiation sources which could substantially affect protection and safety.
5. An authorised person shall ensure that no radiation emitted as a result of the carrying on of his or her undertaking on his or her premises, causes any harm or injury to any person or damage to any property, which is on the premises or elsewhere.
6. An authorised person is liable for any harm to any person or any damage to any property caused by radiation to which sub-regulation (5) applies.
7. An authorised person shall provide sufficient security measures against the misuse or theft of radiation sources under their possession.
8. An authorised person shall ensure that, as applicable and appropriate, the location, design, construction and assembly, commissioning, operation and maintenance, and decommissioning of sources as well as devices and facilities are based on sound engineering practices that—

1. take into account approved codes of practice, standards, technical and scientific developments;
2. are supported by reliable managerial and organisational features; and
3. include adequate margins in the design, construction and operation of sources.

9. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 200 currency points or imprisonment for a term not exceeding 4 years or both.

22. Clearance.

Sources, including substances, materials and objects within authorised practices shall be cleared from further compliance with the requirements of these Regulations, provided that they comply with the exemption levels as specified in Schedule 2, approved by the Council.

Part III—Radiation Protection Perfomance Requirements.

23. Justification of practice.

1. A practice shall not be authorised unless it produces sufficient benefit to the exposed individuals or to society, to offset the radiation harm that it might cause, taking into account social, economic and other relevant factors.
2. An applicant for an authorisation shall provide sufficient information and evidence on the benefits to support the justification of the practice.
3. The following practices shall not be regarded as justified—

1. practices involving food, beverages, cosmetics or any other commodity or product intended for ingestion, inhalation or percutaneous intake by, or application to, a human being;
2. practices involving use of radiation or radioactive substances in commodities or products such as toys, personal jewellery or adornments; and
3. any other practice determined by the Council.

24. Dose limits.

1. The normal exposure of individuals shall be restricted, so that neither the total effective dose nor the total equivalent dose to relevant organs or tissues, caused by the possible combination of exposures from authorised practices, exceeds any relevant dose limits specified in Schedule 3 except in special circumstances considered under regulation 45.
2. A person who contravenes subregulation (1) commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

25. Optimisation of protection and safety.

1. In case of exposures from any particular source within a practice, radiation safety shall be optimised in order to ensure that the magnitude of individual doses are kept as low as reasonably achievable, taking into account economic and social factors, being within the restriction that the dose to individuals delivered by the source is subject to dose constraints,

specified in regulation 26, except in the following situations—

1. therapeutic medical exposures;
2. the number of people exposed; and
3. likelihood of incurring exposures.

2. The process of optimisation of protection and safety measures shall range from intuitive qualitative analysis to quantitative analysis using decision aiding techniques, but shall be sufficient to take all relevant factors into account in a coherent way in order to contribute to achieving the following—

1. to determine optimised protection and safety measures for the prevailing circumstances, with account taken of the available protection and safety options as well as the nature, magnitude and likelihood of exposures; and
2. to establish criteria, on the basis of the results of the optimisation, for the restriction of the magnitudes of exposures and of their probabilities by means of measures for preventing accidents and mitigating their consequences.

26. Dose constraints.

1. Except for medical exposure, the optimisation of the radiation safety measures associated with a given practice shall satisfy the condition that the resulting doses to the individuals of the critical group do not exceed dose constraints which are equal to the dose limits specified in Schedule 3.
2. An authorised person shall, in case of any source that can release radioactive substances to the environment, establish the dose constraints, so that the prospective annual doses to members of the public, including persons distant from the source and those of future generations, summed over all exposure pathways, including contributions by other practices and sources, are unlikely to exceed the dose limits specified in Schedule 3 or lower values established by the Council.
3. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points

27. Safety culture.

1. An authorised person shall establish a management system, commensurate with the size and nature of the authorised activity.
2. The management system shall ensure that—

1. policies and procedures are established to identify protection and safety as being the highest priority;
2. problems affecting protection and safety are promptly identified and corrected in a manner commensurate with their importance;
3. the responsibilities of each individual, including those at senior management levels, for protection and safety are clearly identified and each individual is suitably trained and qualified;
4. clear lines of authority for decisions on protection and safety are defined; and
5. organisational arrangements and lines of communications that result in an appropriate flow of information on protection and safety are effected at and between the various levels in the organisation of a person.

3. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

28. Quality assurance.

1. An authorised person shall establish quality assurance programmes that provide—

1. adequate assurance that the specified requirements relating to protection and safety are satisfied; and
2. quality control mechanisms and procedures for reviewing and assessing the overall effectiveness of protection and safety measures.

2. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

29. Human factor.

1. An authorised person shall ensure that all personnel on whom protection and safety depend are appropriately trained and qualified, in order that they understand their responsibilities and perform their duties with appropriate judgment according to defined procedures, and are periodically retrained.
2. An authorised person, in co-operation with suppliers, shall follow sound ergonomic principles in possessing, obtaining and or designing equipment and preparing operating procedures, in order to facilitate the safe use of equipment and minimise the contribution of human errors to accidents or incidents.
3. An authorised person shall provide appropriate equipment, safety systems and procedures which shall—

1. reduce, as far as practicable, the possibility of human errors leading to unplanned exposure of any person;
2. provide means to detect and prevent human errors and correct or compensate for them; and
3. facilitate early intervention in the event of an accident.

4. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

30. Radiation Safety Officer.

1. An authorised person shall, after consultation with the Council, appoint a qualified person employed by him or her to be a Radiation

Safety Officer in relation to his undertaking.

2. For the purposes of this regulation, where an undertaking consists of practices carried on in two or more premises and involves the use of ionising radiation, a Radiation Safety Officer shall be appointed in respect of each.
3. The qualifications of the Radiation Safety Officer shall include a level of academic knowledge and professional experience compatible with the levels of risk associated with the authorised practices or sources within a practice.
4. The Radiation Safety officer shall—

1. advise his or her employer in all matters pertaining to the protection of workers, patients, the public and the environment from ionising radiation, and the security of radiation sources;
2. advise the user regarding formulation, the observance and enforcement of local rules for the protection of workers, patients, the public and the environment from ionising radiation;
3. advise and liaise with the Council regarding the implementation of radiation protection measures at his or her work place;
4. monitor the purchase and stock levels, the safe use, handling, transport and storage of radioactive materials;
5. inspect and monitor the facility for radiation safety;
6. assist in the training of all relevant aspects of radiation protection;
7. ensure that all workers are monitored regularly with personal dosimetry badges and a record system kept of the doses received;
8. ensure that all reports of the work under the officer are made

available to the council;

1. assist the Council in the enforcement of these regulations in relation to the undertakings for which he or she is appointed and assist the authorised person in keeping all records of the council.

5. A person who contravenes subregulation (1) commits an offence and is liable on conviction to a fine not exceeding 50 currency points or imprisonment for a term not exceeding 2 years or both.

31. Radiation Safety Committee.

1. An authorised person shall, after consultation with the Council, constitute a Radiation Safety Committee for each premise, comprising of—

1. a representative of management;
2. a qualified expert;
3. a representative of workers; and
4. the Radiation Safety Officer.

2. The Radiation Safety Committee shall—

1. review local rules, radiation protection and safety programmes;
2. organise drills and exercises on emergency response for workers;
3. advise authorised persons on how to achieve safety and security of sources.

3. A person who contravenes subregulation (1) commits an offence and is liable on conviction to a fine not exceeding 50 currency

32. Safety and security assessments.

1. An authorised person shall make assessments related to protection, safety and security measures for sources within practices at different stages, including siting, design, manufacture, construction, assembly, commissioning, operation, maintenance, and decommissioning, as appropriate, in order to—

1. identify the ways through which normal exposures and potential exposures can be incurred, taking into consideration the effect of events external to the sources as well as events directly involving the sources and their associated equipment;
2. determine the expected magnitude of normal exposures;
3. estimate the probabilities and magnitude of potential exposures;
4. assess the quality and extent of the protection, and safety provisions; and
5. assess the adequacy of the physical security measures to prevent loss or damage.

2. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

33. Monitoring and verification of compliance.

1. An authorised person shall monitor and measure the parameters necessary for verification of compliance with the requirements of these Regulations.
2. For the purposes of monitoring and verification of compliance, an authorised person using sources in categories 1, 2 and 3 specified in Table 1, Schedule 10, shall be required to—

1. make available an adequate number of survey instruments for

area monitoring at the radiation work place; and

2. maintain, test and caliberate the survey instruments at appropriate intervals with reference to national or international standards.

3. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 50 currency points or imprisonment for a term not exceeding 2 years or both.

34. Records.

1. An authorised person shall keep records of the results of monitoring and verification of compliance, which shall include—

1. records of the tests and calibrations carried out in accordance with these Regulations;
2. radiation dose records;
3. cases of overexposure;
4. medical records;
5. cases of contamination of skin, hair and clothing;
6. area monitoring;
7. leakage tests of sealed radioactive sources;
8. lists of all sealed radiation sources and their details including—
9. location of each source;

2. radionuclide;
3. radio activity on a specified date;
4. serial number or unique identifier;
5. chemical or physical form;
6. each source use history, including recording all movements into and out of the storage location;

(vii) receipt, transfer or disposal of each source.

1. list and radiation dose of persons undergoing treatment or diagnosis;

(j) stocks of unsealed radioactive materials, with dates of receipt, issue and disposal; and supplier's or manufacture's certificate;

(k) investigation of emergencies, accident and disposal of radioactive wastes;

1. maintenance records of apparatus; and

(m) any other relevant information as required by the Council.

2. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 50 currency points or imprisonment for a term not exceeding 2 years or both.

Part VI—Occupational Exposure Protection.

35. General responsibilities of authorised persons and employers.

1. An authorised person and every employer engaged in activities that involve or could involve occupational exposure shall protect the workers against any occupational exposure which is not excluded from these Regulations.
2. An authorised person and an employer shall ensure that for all workers engaged in activities that involve or could involve occupational exposure—

1. occupational exposures are limited as specified in Schedule 3;
2. radiation safety is optimised in accordance with regulations 25 and 26;
3. policies, procedures and organisational arrangements for occupational protection and safety are established to implement the relevant requirements of these Regulations, and the resulting decisions on measures to be adopted for this purpose are recorded and made available to relevant parties, including workers, through their representatives where appropriate;
4. suitable and adequate facilities for radiation safety are provided, including personal protective devices and monitoring equipment, and arrangements are made for their proper use;
5. radiation safety and health surveillance services are provided through qualified experts;
6. arrangements are made to facilitate consultation and co­operation with workers, through their representatives where appropriate, about measures which are required to achieve adequate radiation protection and safety by effective implementation of these Regulations; and
7. necessary conditions are provided and arrangements made to promote a safety culture in the work force and achieve adequate training of workers on radiation safety matters.

3. Where workers are engaged in work that involves or could involve a source which is not under the control of their employer, the authorised person responsible for the source shall—

1. obtain from the employer, as a pre-condition for engagement of such workers, information on their previous occupational exposure history and other information as may be necessary to provide protection and safety in compliance with these Regulations;
2. provide the workers with protective measures and safety provisions which are at least as good as those provided for employees of the authorised person; and
3. make dosimetric and other appropriate information available to the employer for the purpose of demonstrating that the level of protection provided to such workers is compatible with the requirements of these Regulations.

4. Authorised persons and employers shall ensure that workers under their responsibility who are exposed to radiation from sources, other than natural sources, that are not directly related to or required by

their work, receive the same level of protection as if they were members of the public.

5. Authorised persons and employers shall ensure that workers are informed of their obligations and responsibilities for their own protection and the protection of others against radiation and for the safety and security of sources.
6. Authorised persons and employers shall ensure that workers—

1. follow applicable rules and procedures for protection, safety and security;
2. properly use the monitoring devices, the protective equipment and clothing provided;
3. abstain from any willful action that could put themselves or others in situations that contravene the requirements of these Regulations; and
4. promptly report to the authorised person and employer any circumstances that could adversely affect safety or security conditions or the requirements of these Regulations.

7. Authorised persons and employers shall record any report received from a worker that identifies any circumstances that could affect safety and security conditions or non compliance with the requirements of these Regulations, and shall take appropriate remedial actions.
8. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

36. Conditions of service.

1. The employers shall ensure that the conditions of service of workers shall be independent of the existence or the possibility of occupational exposure and special compensatory arrangements or preferential treatment with respect to salary or special insurance coverage, working hours, length of vacation, additional holidays or retirement benefits shall neither be granted nor be used as substitutes for the provision of proper protection and safety measures to ensure compliance with the requirements of these Regulations.
2. Female workers shall be advised by the authorised person or employer that it is desirable to notify the employer of pregnancy.
3. Where a female worker has notified the employer that she is pregnant, the employer shall adapt the working conditions in respect of occupational exposure to ensure that the embryo or feotus is accorded the same broad level of protection, which is required for members of the public, as specified in Schedule 3.
4. The notification of pregnancy shall not be considered a reason to exclude female workers from work.
5. Employers shall make every reasonable effort to provide workers with suitable alternative workplace or employment in circumstances where it has been determined, either by the Council or in the framework of the health surveillance programme required by these Regulations, that the workers, for health reasons, may no longer continue in employment involving occupational exposure.
6. A person under the age of 16 years shall not be subjected to occupational exposure and a person under the age of 18 years shall not be allowed to work in a controlled area unless supervised, for the purpose of the training.
7. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

37. Classification of areas.

(1) There shall be controlled areas where—

1. an authorised person shall designate an area in which specific protective measures or safety and security provisions are or can be required to—

1. control normal exposures or prevent the spread of contamination during normal working conditions; and
2. prevent or limit the extent of potential exposures.

2. an authorised person shall—

1. determine the boundaries of any controlled area on the basis of the magnitude and likelihood of expected exposures and the nature and extent of the required protection and safety provisions;
2. delineate controlled areas by physical means or, where this is not reasonably practicable, by some other suitable means;
3. where a source is brought into operation or energised only intermittently or is moved from place to place, delineate an appropriate controlled area by means that are appropriate under the prevailing circumstances and specify exposure times;
4. display a warning symbol, recommended by the International Organisation for Standardisation (ISO) and appropriate instructions at access points and other appropriate locations within controlled areas as prescribed in Fig.1 Schedule 7;
5. establish occupational protection, safety and security measures, including local rules and procedures that are appropriate for controlled areas;
6. 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 magnitude and likelihood of the expected exposures; and
7. provide at entrances and exits of controlled areas appropriate means for change of clothing, contamination monitoring and personal decontamination.

3. under normal working procedures with sources, the expected contamination shall not exceed the effective dose specified in Schedule 3.

2. An authorised person shall designate, as a supervised area, any area not already designated as a controlled area, but where occupational exposure conditions need to be kept under review even though specific protection measures and safety provisions are not normally needed.
3. An authorised person shall delineate and identify the supervised areas by appropriate means, taking into account the nature and extent of radiation hazards in those areas.
4. An authorised person shall periodically review conditions to determine the possible need to revise the protection measures or safety provisions, including the boundaries of controlled and supervised areas.
5. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

38. Local rules and supervision.

1. An authorised person and employers shall, in consultation with workers, through their representatives where appropriate—

1. establish in writing, in a language comprehensible to the workers and others, such local rules and procedures as are necessary to ensure adequate levels of protection and safety for workers and other persons and for the security of sources;
2. include in the local rules and procedures, the values of any relevant authorised level, investigation level or other reference level and the procedure to be followed in the event that such level is exceeded; and
3. ensure that any work involving occupational exposure is adequately supervised and take all reasonable steps to ensure that the rules, procedures, protective measures and safety

provisions are observed.

2. An authorised person and employers shall—

1. provide to all workers adequate information on the health risks due to their occupational exposure, whether normal exposure or potential exposure, adequate instruction and training on protection and safety, including information on general and local rules and procedures and on available protection and safety provisions, as well as adequate information on the significance for protection and safety of their actions;
2. provide to female workers who are liable to enter controlled areas or supervised areas appropriate information on—

1. the risk to the embryo or foetus due to exposure of a pregnant woman;
2. the importance for a female worker of notifying her employer as soon as she suspects that she is pregnant; and
3. the risk to an infant ingesting radioactive substances by breast feeding;

3. provide to those workers who could be affected by an emergency plan, appropriate information, instruction and training; and
4. keep records of the training provided to individual workers.

3. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 50 currency points or imprisonment for a term not exceeding 2 years or both.

39. Protection of employees.

1. An authorised person or employer shall minimise the need for relying on administrative controls and personal protective equipment for protection and safety during normal operations by providing appropriate well engineered controls and satisfactory working conditions.
2. The authorised person or employer shall ensure that workers and employees are provided with suitable and adequate personal protective equipment, including as appropriate—

1. protective clothing;
2. protective respiratory equipment with information on its protection characteristics and instructions on its proper use; and
3. protective aprons and gloves and organ shields.

3. The authorised person or employer shall arrange for regular testing and maintenance to be carried out on all personal protective equipment, including as required, special equipment for use in the event of accidents and interventions.
4. The authorised person or employer shall take into account the following factors when assigning personal protective equipment for a given task—

1. medical fitness to sustain possible extra physical effort while using the protective equipment; and
2. additional work time or inconvenience or additional non radiological risks associated with the use of the protective equipment.

5. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

40. Exposure assessment.

1. Authorised persons and employers shall arrange for the assessment of the occupational exposure of workers and shall ensure that adequate arrangements are made for the provision of such services by a dosimetry laboratory approved by the Council.
2. A worker who is normally engaged in a controlled area, where individual monitoring is not feasible shall be assessed on occupational exposure, on the basis of the results of monitoring of the workplace and on information on the location and duration of exposure of the worker.
3. A worker who is normally engaged in a supervised area or who enters a controlled area only occasionally, shall be assessed on occupational exposure, on the basis of the results of monitoring of the workplace or individual monitoring.
4. The nature, frequency and precision of individual monitoring shall be determined by consideration of the magnitude and possible fluctuations of exposure levels and the likelihood and magnitude of potential exposures.
5. Authorised persons and employers shall ensure that workers who may be exposed to radioactive contamination, including workers who use protective respiratory equipment, are identified and shall arrange for appropriate monitoring to the extent necessary to demonstrate the effectiveness of the protection provided and to assess the intake of radioactive substances or the committed doses, as appropriate.
6. Authorised persons and employers shall keep records of exposure which shall be made available to workers and the Council when required.
7. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 50 currency points or imprisonment for a term not exceeding 2 years or both.

41. Monitoring of workplace.

1. Authorised persons, in co-operation with employers where appropriate, shall establish, maintain and keep under review a programme for the monitoring of the workplace commensurate with the nature of the source and the risks associated with the source.
2. The nature and frequency of monitoring of a workplace shall—

1. be sufficient to enable—

1. evaluation of the radiological conditions in all workplaces;
2. assessment of the exposure of workers in controlled areas and supervised areas; and
3. review of the classification of controlled and supervised areas.

2. depend on the levels of ambient dose equivalent and airborne and surface activity concentration, including their expected fluctuations and the likelihood and magnitude of potential exposures.

3. The programmes for monitoring of the workplace shall specify—

1. the quantities to be measured;
2. where and when the measurements are to be made and at what frequency;
3. the most appropriate measurement methods and procedures; and
4. reference levels and the action to be taken where they are exceeded.

4. An authorised person shall keep appropriate records of the findings of the work place monitoring programme, which shall be made available to workers, through their representatives where appropriate.
5. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 50 currency points or imprisonment for a term not exceeding 2 years or both.

42. Health surveillance.

1. Authorised persons and employers, in accordance with rules

84

established by the Council, shall make arrangements for appropriate health surveillance based on the general principles of occupational health designed to assess the initial and continuing fitness of workers for their intended tasks.

2. Authorised persons and employers shall take the medical history or otherwise health surveillance of workers before they take employment in a radiation related workplace.
3. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 50 currency points or imprisonment for a term not exceeding 2 years or both.

43. Records of worker exposure.

1. Authorised persons and employers shall maintain records of exposure for each worker for whom assessment of occupational exposure is required under regulation 42 and the worker exposure records shall include information on—

1. the general nature of the work resulting in exposure, the doses and intakes at or above the relevant recording levels and the data upon which the dose assessments are based;
2. the periods of employment with different employers, if any, and the corresponding doses and intakes in each period of employment; and
3. the doses or intakes due to emergency interventions or accidents, which shall be distinguished from doses and intakes received during work in normal conditions.

2. Authorised persons and employers shall—

1. provide for access by workers to information of their own exposure records and workplace monitoring where appropriate; and
2. upon request by the Council or other persons or organisations with a demonstrated need for such records, including relevant

employers and supervisors of the health surveillance programme, provide access to worker exposure records with due care and attention to the maintenance of appropriate confidentiality.

3. Exposure records for each worker shall be kept by the authorised persons and employers, or by the Council or other designated organisation where the authorised persons or employers cease their activities.
4. Records kept under subregulation (3) shall be preserved at least until the worker attains or would have attained the age of seventy five years, and for not less than thirty years after the termination of the work involving occupational exposure.
5. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

44. Investigation of accidental occupational exposures.

1. An authorised person shall promptly investigate any repeated equipment failure, accident, error, mishap or other unusual occurrence with the potential for causing a worker exposure significantly different from that intended.
2. An authorised person shall, with respect to any investigation required—

1. estimate the doses received and their distribution within the worker;
2. indicate the corrective measures required to prevent recurrence of such an accident;
3. implement all the corrective measures that are under the authorised person's responsibility;
4. notify the Council and other relevant agencies by telephone or electronic mail or any other efficient means of

communication as soon as practicable, but not later than twenty four hours after discovery of the accident which has the potential for, or has resulted in, serious injury or death of a worker, or which involve more than one worker;

5. for minor injuries, notify the Council by telephone or electronic mail or any other efficient means of communication as soon as possible;
6. submit to the Council, within fifteen days after discovery of the accident, a written report which states the cause of the accident and includes information on the doses, corrective measures and any other relevant information; and
7. inform the worker and his or her doctor about the accident.

5. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 50 currency points or imprisonment for a term not exceeding 2 years or both.

45. Special circumstances.

1. If a practice which is justified and for which radiation safety is optimised, presents special circumstances which require a temporary change in some dose limitation requirements of these Regulations, an authorised person shall not make any temporary change without the approval of the Council.
2. The application submitted by the authorised person to obtain this approval shall include evidence to demonstrate that—

1. all reasonable efforts have been made to reduce exposures and optimise radiation safety provisions in accordance with these Regulations; and
2. the relevant employers and workers, through their representatives where appropriate, have been consulted on the need for and the conditions of the temporary change in dose limitation requirements.

3. A temporary change in the dose limitation requirement shall be limited to specified work areas and shall be in accordance with the time and dose limitations for special circumstances specified in Schedule 3.
4. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 200 currency points or imprisonment for a term not exceeding 4 years or both.

Part VII—Medical Exposure Protection.

46. General responsibilities under medical exposure.

1. An authorised person shall ensure that—

1. no patient is administered a diagnostic or therapeutic medical exposure unless the exposure is prescribed by a medical practitioner;
2. medical practitioners are assigned the primary task and obligation of ensuring overall patient protection and safety in the prescription of, and during the delivery of, medical exposure;
3. medical and paramedical personnel are available as required, and are either health professionals or have appropriate training to adequately discharge assigned tasks in the conduct of the diagnostic or therapeutic procedures that the medical practitioner prescribes;
4. for therapeutic uses of radiation including teletherapy, brachytherapy and nuclear medicine, the calibration, dosimetry and quality assurance requirements of these Regulations are conducted by or under the supervision of a qualified expert in radiotherapy physics;
5. the exposure of individuals incurred knowingly while voluntarily helping, other than in their occupation in the care, support or comfort of patients be constrained as specified in Schedule 3; and
6. personnel engaged in diagnostic or therapeutic uses of radiation are well trained and qualified according to the criteria approved by the Council.

2. An authorised person shall, as far as practicable, ensure that for diagnostic uses of ionising radiation, the imaging and quality assurance requirements of these Regulations are complied with, on the advice of a qualified expert in radiodiagnostic physics, nuclear medicine physics and radiopharmacy in the compounding of radiopharmaceuticals, as appropriately required.
3. Medical practitioners shall promptly inform the authorised person of any deficiencies or needs regarding compliance with these Regulations with respect to protection and safety of patients and shall take action as may be appropriate to ensure the protection and safety of the patients.
4. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 200 currency points or imprisonment for a term not exceeding 4 years or both.

47. Justification of medical exposure.

1. Medical practitioners shall consider the justification of medical exposures that they prescribe by weighing the diagnostic or therapeutic benefits they produce against the radiation detriment they might cause, taking into account the benefits and risks of available alternative techniques that do not involve medical exposure.
2. Any radiological examination for occupational, legal or health insurance purposes undertaken without reference to clinical indications shall be deemed unjustified unless it is expected to provide useful information on the health of the individual examination or unless the specific type of examination is justified by those requesting it in

consultation with relevant professional bodies.

3. Mass screening of population groups involving medical exposure shall be deemed unjustified unless the expected advantages for the individuals examined or for the population as a whole are sufficient to compensate for the economic and social costs, including the radiation detriment.
4. The exposure of humans for medical research shall be deemed to be unjustified unless it is—

1. in accordance with the Helsinki Declaration [1964] specified in Schedule 8 and follows the guidelines for its application prepared by the Council for International Organization for Medical Science (CIOMS) and the World Health Organization (WHO); and
2. subject to the advice of the Ethical Review Committee and to any other applicable laws and regulations.

5. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 200 currency points or imprisonment for a term not exceeding 4 years or both.

48. Optimisation of protection for medical exposure.

1. In addition to satisfying the general requirements for optimisation of radiation safety specified in these Regulations, an authorised person, in co-operation with suppliers where appropriate, shall satisfy the prescriptive design and operational requirements specified in Schedule 4.
2. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 200 currency points or imprisonment for a term not exceeding 4 years or both.

49. Calibration, clinical dosimetry and quality assurance for

medical exposures.

1. Authorised persons shall ensure that—

1. the calibration of sources used for medical exposure is traceable to a Standards Dosimetry Laboratory approved by the Council;
2. each type of radiotherapy equipment is calibrated in terms of the relevant dosimetric quantities and irradiation conditions;
3. unsealed sources for nuclear medicine procedures are calibrated in terms of activity of the radio-pharmaceuticals to be administered; and
4. calibrations of equipment are carried out at the time of commissioning of a source, after any maintenance procedure that may affect the calibration, at least once in a year as well as at regular intervals approved by the Council, taking into consideration the manufacturer’s recommendation and risk associated with the practice.

2. Authorised persons shall ensure that representative values of clinical dosimetry parameters are determined and documented.
3. Quality assurance programmes for medical exposures shall include—

1. measurements of the physical parameters of the radiation generators, imaging devices and irradiation installations at the time of commissioning and periodically thereafter;
2. verification of the appropriate physical and clinical factors used in patient diagnosis or treatment;
3. written records of relevant procedures and results;
4. verification of the appropriate calibration and conditions of operation of dosimetry and monitoring equipment; and
5. as far as possible, regular and independent quality audit reviews of the quality assurance programme for radiotherapy procedures.

4. A person who contravenes subregulation (1) and (2) commits an offence and is liable on conviction to a fine not exceeding 200 currency points or imprisonment for a term not exceeding 4 years or both.

50. Dose constraints.

1. The optimisation of protection of persons exposed for medical research purposes, if such medical exposure does not produce direct benefit to the exposed individuals, shall be subject to individual dose constraints established on a case-by-case basis by the Ethical Review Committee or other institutional body assigned a similar function.
2. Authorised persons shall constrain any dose to individuals incurred while voluntarily helping, other than in their occupation, in the care, support or comfort of patients undergoing medical exposure, and to visitors of patients who have received therapeutic amounts of radio nuclides or who are being treated with brachytherapy sources, to a level not exceeding that specified in Schedule 3.
3. A person who contravenes subregulation (2) commits an offence and is liable on conviction to a fine not exceeding 200 currency points or imprisonment for a term not exceeding 4 years or both.

51. Guidance levels.

1. Authorised persons shall ensure that guidance levels for medical exposure, as specified in Schedule 5, are revised as technology improves and are used as guidance by medical practitioners, in order to ensure that—

1. corrective actions are taken as necessary where doses or activities fall substantially below the guidance levels, resulting in a decrease of medical benefit to patients by ineffective diagnostic information or insufficient therapeutic dosage;
2. review actions are considered where doses or activities exceed the guidance levels, as an input to ensuring optimised protection of patients and maintaining appropriate levels of good practice; and
3. during the transition period, the performance of diagnostic radiology and nuclear medicine equipment is assessed.

2. Guidance levels for medical exposure shall be used by medical practitioners in the conduct of diagnostic and therapeautic procedures involving exposure to radiation as well as in the optimisation of protection of patients and the guidance level of activity for discharge of a patient from a hospital.
3. The guidance levels shall be established by relevant professional bodies or well known specialists in consultation with the Council, in order to provide an indication on what doses are achievable with current good practice for average sized patients.
4. The guidance levels shall be applied with flexibility to allow higher exposures, where they are indicated by sound clinical judgment and shall be revised as required by technological and scientific developments.
5. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 200 currency points or imprisonment for a term not exceeding 4 years or both.

52. Maximum activity for patients in therapy on discharge from

hospital.

1. The authorised person shall not discharge a patient from hospital before the activity of radioactive substances in the body falls below the level specified in Table 6, Schedule 5 unless otherwise justified and the justification is documented in order to restrict the exposure of any members of the household from a patient who has undergone a therapeutic procedure with sealed and or unsealed radio nuclides and of members of the public.
2. Written instructions by an authorised person to the patient concerning contact with other persons and relevant precautions for radiation protection shall be provided where necessary.
3. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

53. Investigation of accidental medical exposures.

1. An authorised person shall promptly investigate any of the following accidents—

1. a therapeutic treatment delivered to either the wrong patient or the wrong tissue, or using the wrong pharmaceutical, or with a dose or dose fractionation differing substantially from the value prescribed by the medical practitioner;
2. a diagnostic exposure substantially greater than intended or resulting in doses repeatedly and substantially exceeding the established guidance levels; and
3. a repeated equipment failure, accident, error, mishap or other unusual occurrence with the potential for causing a patient exposure significantly different from that intended.

2. An authorised person shall, with respect to any investigation required under subregulation (1)—

1. calculate or estimate the doses received and their distribution within the patient;
2. indicate the corrective measures required to prevent recurrence of such an accident;
3. implement all the corrective measures that are under their own responsibility;
4. notify the Council by telephone or electronic mail or any other efficient means of communication as soon as practicable, but not later than twenty four hours after discovery, of any accident which has the potential for, or has resulted in, serious injury or death of a patient, or which involves more than one patient;
5. notify the Council about any minor injuries by telephone or electronic mail or any other efficient means of communication as soon as practicable, but not later than forty eight hours after discovery;
6. submit to the Council, within fifteen days after discovery of the accident, a written report which states the cause of the accident and includes information on the doses, corrective measures and any other relevant information; and
7. inform the patient and his or her doctor about the accident.

3. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

54. Medical dosimetry records.

1. An authorised person shall keep and make available, as required, records of equipment calibration, clinical dosimetry and quality assurance, as well as any other necessary information to allow retrospective assessments of the doses received by patients.
2. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

Part VIII—Public Exposure Protection.

55. General responsibilities for authorised person for public exposure.

1. Authorised persons shall apply the requirements of these Regulations to any public exposure delivered by a practice or source for which they are responsible, unless the exposure is excluded from the regulations or the practice or source delivering the exposure.
2. Authorised persons shall be responsible, with respect to the sources under their charge for the establishment, implementation and maintenance of—

1. radiation safety policies, procedures and organisational arrangements for control of public exposure;
2. measures for ensuring—

1. the optimisation of the protection, subject to constraints as may be appropriate, of members of the public whose exposure is attributable to such sources; and
2. the limitation of the normal exposure of the relevant critical group, which is attributable to such sources, in order that the total exposure is not higher than the dose limits for members of the public as specified in Schedule 3;

3. measures for ensuring the safety and security of such sources, in order that the likelihood of public exposures is controlled in accordance with the requirements of these Regulations;
4. suitable and adequate facilities, equipment and services for the protection of the public, the nature and extent of which are commensurate with the magnitude and likelihood of the potential exposure;
5. appropriate radiation safety training, and periodic retraining to the personnel having functions relevant to the protection of the public;
6. appropriate monitoring equipment and surveillance programmes to assess public exposure;
7. adequate records of the surveillance and monitoring programmes; and
8. informing the public and particularly critical groups about radiation safety measures to be taken in case of an accident or

incident.

3. Authorised persons shall be responsible for informing the public and particularly critical groups, about radiation safety measures to be taken in case of an accident or incident.
4. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

56. Control of visitors.

1. Authorised persons shall—

1. ensure that visitors are accompanied in any controlled area by a person knowledgeable about the radiation safety measures for that area;
2. provide adequate information and instruction to visitors before they enter a controlled area, to ensure appropriate protection of the visitors and of other individuals who could be affected by their actions; and
3. ensure that adequate control over entry of visitors to a supervised area is maintained and that appropriate signs are posted in such areas.

2. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 50 currency points or imprisonment for a term not exceeding 2 years or both.

57. Source of external irradiation.

1. Authorised persons shall ensure that, if a source of external irradiation can cause exposure to the public—

1. prior to commissioning, the floor plans and equipment, arrangement for all new installations, and all significant modifications to existing installations utilising such sources of external irradiation are subject to review and approval by the

Council;

2. specific dose constraints for the operation of such a source are established to the satisfaction of the Council; and
3. shielding and other protective measures that are optimised in accordance with the requirements of these Regulations and measures are provided as appropriate for restricting public exposure to the satisfaction of the Council.

2. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

58. Radioactive contamination in enclosed spaces.

1. Authorised persons shall ensure that—

1. for sources for which they are responsible, measures that are optimised in accordance with the requirements of these Regulations are taken as appropriate for restricting public exposure in areas accessible to the public; and
2. specific containment provisions are established for the construction and operation of those sources in order to avoid or minimise the spread of contamination in areas accessible to the public.

2. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

59. Discharge of radioactive materials.

1. Subject to regulation 78, authorised persons shall ensure that radioactive materials from practices and sources are not discharged to the environment.
2. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

60. Monitoring of public exposure.

1. Authorised persons shall, as appropriate—

1. establish and carry out a monitoring programme of a magnitude and complexity commensurate with the type of risks associated with the sources under their responsibility, which is sufficient to ensure that the requirements of these Regulations are complied with and the monitoring programme shall assess the exposure of members of the public from sources of external irradiation and discharges of radioactive substances into the environment;
2. keep appropriate records of the results of the monitoring programmes; and
3. report a summary of the monitoring results to the Council every year and promptly inform the Council of any abnormal results which lead or may lead to an increase of public exposure.

2. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

61. Consumer products.

1. Consumer products capable of causing exposure to radiation shall not be supplied to members of the public unless—

1. the exposure is excluded as specified in regulation 6; or
2. such products meet the exemption requirements specified in regulation 14 or have otherwise been exempted by the Council; or
3. such products are authorised by the Council for use by members of the public.

2. Persons who import consumer products, as exempt products, for subsequent sale and distribution shall include in the application to the

Council for authorisation to distribute, a copy of the licence or authorisation issued by the Regulatory Authority in the country of manufacture or origin.

3. Persons who import consumer products for sale and distribution as exempt products shall ensure that—

1. legible and prominently featuring radioactive labels are visibly and firmly affixed to each consumer product and its package, stating, in the English language, that—

1. the product contains radioactive materials; and

2. the sale of the product to the public has been authorised by the Council.

2. basic information and instructions on the precautions of use and disposal of the product, written or translated in the local language, are made available with the product.

4. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 150 currency points or imprisonment for a term not exceeding 4 years or both.

Part IX—Requirements for the Safety and Security of Sources.

62. General responsibilities of authorised person for safety and

security of sources.

1. Authorised persons shall ensure the safety and security of the sources under their responsibility, from the moment of their acquisition throughout their entire operational life, up to their final disposal.
2. Authorised persons shall ensure that a multilayer system of provisions defence in depth for protection and safety commensurate with the magnitude and likelihood of the potential exposures involved is applied to the source under their responsibility such that a failure at one layer is compensated for or corrected by subsequent layers, for the purpose of—

1. preventing accidents that may cause unintended exposure;
2. mitigating the consequences of any such accident should it occur; and
3. restoring sources to safe conditions after any such accident.

3. Authorised persons shall ensure that, as far as appropriate, the location, design, construction and assembly, commissioning, operation and maintenance, and decommissioning of sources is based on sound engineering practice which—

1. takes into account approved codes, standards, technical and scientific developments;
2. is supported by reliable managerial and organisational features; and
3. includes adequate safety margins in the design, construction and operation of sources.

4. A person who contravenes this provision commits an offence and is liable on conviction to a fine not exceeding 200 currency points or imprisonment for a term not exceeding 4 years or both.

63. Storage of radiation sources.

1. Authorised persons shall ensure that the following requirements with regard to storage of radiation sources are complied with—

1. when not in use, radiation sources shall be kept in a place of storage assigned for this purpose only, bearing the appropriate warning symbol while they are not in use;
2. the place of storage shall be adequately shielded such that at the outside surface of its walls or containment, the radiation dose shall not exceed 0.01 mSv per hour, and shall be chosen in order to minimise risks from fire or flood;
3. the place of storage shall be inspected regularly and checked for possible contamination at such a frequency as approved by

4. 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; and
5. if the place of storage is to contain either sealed or unsealed radiation sources that are liable to release a radioactive gas or vapour the store shall be continuously vented to the open air, or provided with a mechanical venting system that can be operated from outside the store before the store is opened.

2. All radiation sources shall be clearly labeled, giving information on their activity, nature and physical form.
3. The containers for beta emitting radionuclides shall have adequate thickness to reduce the primary radiation to a safe level and considerable bremsstrahlung radiation may arise from high intensity sources and additional shielding shall be provided.
4. Gamma emitting 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.
5. Appropriate equipment shall be provided for storing unsealed radiation sources to prevent both external irradiation, hazards and internal contamination hazards.
6. Records shall be kept of all stored radiation sources and the records 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.
7. An authorised person shall ensure that inventories are updated periodically.
8. 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.
9. A person who contravenes this provision commits an offence