The Malawi Gazette Supplement, dated 18th February, 2011, containing a Bill

NOTICE

The following Bill, for introduction in Parliament, is published for general information.

Lilongwe, 18th February, 2011.

M. M. Katopola
Clerk of Parliament

ATOMIC ENERGY BILL, 2011 MEMORANDUM

This Bill seeks to introduce comprehensive legislation to provide for the adequate protection of people as well as the environment against the harmful effects of radiation sources, nuclear material and radioactive materials.

Although currently Malawi has some legislation that contains reference to nuclear science and technology, the legislation is inadequate for the comprehensive regulation and management of radiation sources, nuclear material and radioactive materials. The regulatory framework is sectoral and therefore fragmented in nature and as such does not provide a comprehensive and coordinated approach to the regulation and management of atomic energy related activities. In most cases, the pieces of legislation address only an aspect, such as the need to safeguard the health of individuals or society and the need to minimize negative impacts to the environment.

Further, the current legislation that contains reference to nuclear science and technology does not provide for health and safety when handling radiation sources, nuclear material and radioactive materials activities and nuclear sources, security of nuclear sources from theft, sabotage, unauthorized access, illegal transfer or other malicious acts involving nuclear materials; and safeguard mechanisms for disaster preparedness responses in the event of nuclear related emergencies.

Some of the sectoral regulatory frameworks related to nuclear activities in the country include—

(a).The Environment Management Act which provides for a general environmental management regulatory framework including waste management;

(b) The Occupational Safety and Health Act which provides for safety or workers from ionizing radiation;

57. Export of radioactive waste

Part XI

Transportation of Radioactive Material

58. Requirement for a licence to transport radioactive waste material

59. Regulations on transportation of radioactive waste material

Part XII

Mining and Processing

60. Licence for mining and processing radioactive minerals
     
61. Application for licence
     
62. Responsibilities of a licensee for safety and security of activities

Part XIII

Security, Physical Protection and Safeguards

63. National register of radioactive sources
     
64. Import and export of radioactive sources
     
65. Recovery of orphan sources
     
66. Peaceful use commitments
     
67. Prohibited activities
     
68. Application of safeguards
     
69. Cooperation in Implementation of Safeguard

Part XIV

Offences and Penalties

 

70. offences relating to licences

71. Hindering and obstructing of inspectors

72. Offences relating to records

73. Prohibition of disclosure of information by employee of Authority

74. Handling of radioactive or nuclear material and devices

75. Use of radioactive or nuclear material

76. General offences and penalty

77. Extraditable offence

The Secretariat of the Authority shall have the following functions, to—

(a) establish and maintain a national register of radiation sources and of licensed persons to carry out an activity or practice;

(b) define in the licence the detailed conditions, including financial obligations, to be placed on the licensee;

(c) review and assess submission on safety from an applicant both prior to granting the licence and periodically during operation, as required;

(d) conduct inspections and visits and facilitate the performance of verification activities by designated inspectors of the International Atomic Energy Agency in accordance with the Safeguards Agreement and the Additional Protocol thereto;

(e) establish appropriate mechanisms for informing the public, media, and other stakeholders about the regulatory process, and radiation safety and security aspects of regulated activities or practices and about incidents and accidents;

(f) collect and disseminate information on the work of the Authority; and

(g) perform such other functions from time to time as may be assigned by the Board.

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Part III—

Financial Provisions

18. FUNDING OF THE AUTHORITY

—(1) The Government shall provide the Authority with adequate financial resources, to enable the Authority to fulfill its responsibilities under this Act and applicable regulations.

(2) The funds of the Authority shall consist of such moneys as may—

(a) be appropriated by Parliament for the purposes of the Authority;

(b) be collected as fees, penalties and other charges; and

(c) otherwise vest or accrue to the Authority.

(3) The Authority may, subject to the approval of the Minister—

(a) accept grants or donations:

Provided that the grants or donations do not come from persons that are subject to regulatory control of the Authority and do not lead to any conflict of interest; or

(b) raise by way of loans, such moneys as it may require to discharge its functions.

(4) The Authority may invest in such manner as it thinks fit such funds as it does not immediately require for the performance of its functions.

19. FINANCIAL YEAR

—The financial year of the Authority shall be the period of twelve months commencing on 1st July in one year and ending on the 30th of June of the following year; or such other dates as the responsible Minister may specify by order published in the Gazette:

Provided that the first financial year of the Authority may be a period shorter or longer than twelve months but in any event not longer than eighteen months.

20. ACCOUNTS

—(1) The Authority shall—

(a) keep and maintain proper books of accounts and other records relating to its funds and other assets of the Authority; and

(b) in every aspect comply with the Public Finance Management Act, Public Audit Act and Public Procurement Act so far as these Acts are applicable to statutory bodies.

(2) The accounts of the Authority shall be audited annually by the Auditor General.

(3) The auditor’s fees shall be paid by the Authority.

21 ANNUAL REPORT

—(1) The Authority shall prepare, as soon as practicable, but not later than three months after the end of the financial year, an annual report of the activities of the Authority.

(2) The Board shall submit a report to the Minister, and the Minister shall lay the report before the National Assembly annually.

(3) The report referred to in subsection (1) shall include also information on the financial affairs of the Authority and there shall be appended to the report—

(a) an audited balance sheet;

(b) an audited statement of income and expenditure; and

(c) such other information as the Minister may require.

(4) The Authority shall publish the report and disseminate it to the general public.

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Part IV—

Notification and Licensing

22. REQUIREMENT FOR A NOTIFICATION

Any person who intends to engage in an activity or practice shall submit a notification to the Authority of his intention to carry out such activity or practice in the form and within the time limits required by the Authority, and specified in the regulations.

23. REQUIREMENT FOR A LICENCE

A person shall not engage in any activity or practice unless specifically licensed by the Authority.

24. LICENCE PROCESS

The Authority shall make publicly available information on the licensing process, including, inter alia—

(a) criteria to be considered in licensing decisions and their legal basis, including a requirement that an explanation of the reasons for rejection of a submission shall be provided to the applicant;

(b) conditions and qualifications that shall be met by the applicant for a licence;

(c) procedures and requirements for suspension, modification, renewal, revocation or relinquishment of licences;

(d) procedures and requirements for public participation in the licensing process;

(e) procedures and requirements for the release of information concerning licensing proceedings, including measures for the protection of classified and proprietary information; and

(f) description of any fees required for licences

25. CONDITION FOR GRACING LINCECES—

(1) Prior to being granted a licence, the applicant shall present sufficient evidence that he—

1. possesses an adequate understanding of the fundamental principles of radiation protection, nuclear safety and security;

2. shall take all steps necessary for the protection and safety of workers and the public, including by keeping doses below the relevant threshold and ensuring that all reasonable steps are taken to minimize adverse effects in the population, at present and in the future;

3. shall plan and implement the technical and organizational measures necessary to ensure adequate safety, including effective defenses against radiological hazards;

4. shall prepare and implement an appropriate emergency plan;

5. shall ensure compliance with the dose limits established by the Authority and shall monitor the radiation exposure of workers;

6. possesses adequate human and financial resources to conduct the proposed activity or practice in a manner that ensures nuclear safety and security;

7. has made all necessary contractual arrangements for the return of the radioactive source, at the end of its useful life, to the supplier, its successor, and in any case to the exporting country or the place of origin;

8. has made adequate financial arrangements for waste disposal, decommissioning and potential liability for radiological damage;

9. shall provide access by inspectors of the Authority to premises necessary for the performance of their duties;

10. shall not modify the conduct of any licensed activity or practice in a manner that could affect the protection of workers, the public and the environment as well as the nuclear security, without seeking the approval of the Authority; and

11. shall provide, upon request or pursuant to the requirements in relevant regulations, all information considered to be necessary by the Authority.

2. The Authority shall further, prior to granting a licence, take into consideration, the impact of the proposed activity or practice on the environment, and the social, economic, cultural and recreational conditions of any of the community concerned.

3. Notwithstanding subsectAnmiEndgyO, the Authority shall, in granting a licence or a renewal of a licence, take into considera­tion relevant Government policies and any written law and any other matter that the Board may consider likely to have a bearing on the activities of the licensee.

26. VALIDITY, RENEWAL AND TRANSFER OF LICENCES

—(1) A licensee shall, before the expiry of a licence, and within the prescribed period, apply to the Authority for renewal of the licence.

2. A licence shall cease to be valid when any time limit established therein has expired or any condition of the licence has not been met, in accordance with the enforcement process established by the Authority.

3. A licence shall not be transferable.

27. MODIFICATION OF CONDITIONS OF LICENCE

—(1) The Authority may modify the conditions of a licence on its own motion or on application by the licensee.

(2) Where the Authority intends to modify the conditions of a licence, it shall inform the licensee in the prescribed manner of its intention to do so and give the licensee an opportunity to be heard.

28. REFUSAL TOISSUE LICENCE

—(1) The Authority may refuse to issue a licence if—

1. the applicant fails to meet the conditions as specified under section 25, or in applicable regulations;
    
2. any licence formerly issued to the applicant under this Act has been revoked by the Board;
    
3. the applicant has been convicted of an offence involving fraud or dishonesty; or
    
4. the applicant has been convicted of an offence under any written law and sentenced to a term of imprisonment without the option of a fine.

(2) Where the Authority refuses to issue a licence under subsection (1), it shall, within ninety days from the receipt of the application, notify the applicant in writing of the refusal to issue the licence to the applicant and shall state the reasons for the refusal.

29. REVOCATION AND SUSPENSION OF LICENCE

—(1) The Authority may, where it is satisfied that a licensee is not operating in accordance with the terms and conditions of the licence, this Act or prescribed regulations, and after affording the licensee a reasonable opportunity to be heard, revoke or suspend a licence if the breach—

1. would pose an unacceptable risk to the public or the environment;
    
2. continues after two consecutive warnings; or
    
3. causes the Board to believe that it is likely that the licensee is unable to fulfill his duties under the licence or under this Act.

(2) The authority shall revoke a licence if the licence was obtained fraudulently or by deliberate or negligent submission of false information.

(3) Where the Authority suspends a licence, it may direct the storage of radiation sources under such conditions to prevent exposure of the public or workers to potential radiation hazards above prescribed limits.

(4) Where the Authority revokes or suspends a licence, it shall take such action as it deems necessary to ensure that all the activities authorized by the licence cease immediately.

30. RELINQUISH­MENT OF LICENCE

A licence may be relinquished by the licensee upon notice to the Authority and upon a determination by the Authority that relinquishment will not jeopardize the protection of the public or the environment.

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Part V—

Responsibilities of a Licensee

31. RESPONSIBILITIES OF LICENSEE

—(1) The primary responsibility for the safety and security of radiation sources and nuclear materials rests with the licensee who may seek further advice from the Authority.

(2) A licensee shall—

(a) carry out the activity or practice in accordance with the provisions of this Act, the regulations and the conditions of his licence;

(b) keep records and compile reports relating to radiation safety and security regulations required to be observed under this Act;

(c) prepare, in consultation with the Authority, radiation safety and security rules within an activity or practice; and

(d) provide the Authority with any requested assistance in the performance of its regulatory functions.

(3) During operation, and in case of intended modification of the conditions of the licence, the licensee shall provide all available information, as may be required by the Authority.

(4) A licensee undertaking more than one licensed activity or practice shall keep separate records and reports for each activity or practice.

32. DUTY OF LICENSEE TO APPOINT RADIATION SAFETY OFFICER

—(1) A licensee shall, after consultations with the Authority, appoint a qualified and technically competent person to oversee radiation protection.

(2) The functions of the person appointed to oversee radiation protection shall be prescribed in regulations.

(3) The Authority may, whAromCenergy, direct a licensee to appoint more than one person to oversee radiation protection in respect of such portions of the operations of the licensee as the Authority may determine.

33. NOTICE OF INTENDED TERMINATION OF OPERATIONS

Where a licensee intends to terminate operations, he shall, at least six months prior to commencement of termination, notify the Authority in a prescribed manner, of his intended termination of operations and shall follow the prescribed termination procedure or where no procedure is prescribed, such procedure as the Authority may determine in order to ensure the nuclear safety and security of the public and the environment.

34. NOTICE OF INCIDENTS OR ACCIDENTS

—(1) A licensee shall, immediately, and in any case, within twenty four hours, notify the Authority of any incident or accident which has occurred, as may be defined in the regulations.

(2) A licensee shall, within a period prescribed by the Authority, submit to the Authority a written report of the incident or accident referred to in subsection (1).

35. LIABILITY OF LICENSEE

—(1) Every licensee shall be responsible for ensuring that no radiation emitted as a result of the carrying on of his undertaking on his premises, causes any harm or injury to any person or damage to any property which is on the premises or elsewhere subject to subsection (4).

2. No person other than the licensee shall be under any liability in respect of any harm to any person or any damage to any property caused by any radiation to which subsection (1) applies.

3. No licensee shall incur any liability by virtue of subsection (1) in respect of any radiation whose emission, or the causing of any harm to any person or any damage to any property by their emission, is attributable to hostile action in the course of civil strife, any armed conflict, including any armed conflict within Malawi.

4. Whenever a physical or mental disability occurs in a person, and which an approved medical practitioner—

1. ascribes to radiation exposure, the disability shall be presumed to have resulted from exposure to radiation from a source of strength sufficient to give rise to such disability;

2. ascribes to radiation as well as to other causes, the following factors shall be considered for the purposes of establishing the cause of the disability, namely—

(i) if the disability is of a nature known to be capable of being caused by either radiation or any other cause that it appears that the person may have been exposed to a source of radiation of a strength sufficient to have caused the disability,

it shall be presumed that the disability arose from one or more of such exposures, if no record of personal exposures have been maintained to a standard approved by the Authority;

2. if the disability is of a nature known to be capable of arising from radiation and from any other possible cause, and there exists a person who indicates that there have occurred in relation to him exposures in excess of the recommended dose limits, it shall be presumed that the disability occurred as a result of that radiation exposure; or

3. if the disability is of a nature known to be capable of rising from radiation and from any other possible cause, and there exists a personal radiation exposure record in respect of that person which has been maintained to a standard approved by the Authority, it shall be presumed that the disability did not arise from radiation exposure if the record indicates that the exposures have been within the permissible limits on all possible occasions of exposure.

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Part VI —

Inspections and Enforcement

36. INSPECTIONS PROGRAMME

—(1) The Authority shall establish an inspection programme, including announced and unannounced inspections, to monitor compliance with the requirements of this Act or any applicable regulations or conditions of a licence.

(2) The Authority shall ensure that the inspection programme is supported by adequate financial, technical and human resources to meet its objectives.

(3) The Authority shall establish qualification requirements for a training programme for inspectors.

37. CONDUCT OF INSPECTIONS

The Authority may conduct any inspections and carry out such other examination, as may be necessary, to confirm and verify compliance with the provisions of this Act, applicable regulations and conditions of a licence.

38. APPOINTMENT OF INSPECTORS

—(1) The Authority shall, with the approval of the Board, appoint such number of suitably qualified inspectors to enforce compliance with the provisions of this Act, applicable regulations and conditions of a licence.

(2) The Authority shall issue to the inspectors appointed under subsection (1) identification cards signed by the Executive Director.

(3) An inspector shall, while exercising his powers or performing his duties in terms of this Act, on request by any interested person, produce the identification card.

(1) Subject to the restrictions provided for in the regulations, an inspector shall, for the purposes of monitoring or enforcing compliance with this Act, have access at any time, to all parts of the premises or facilities where activities or practices are carried out, with a view to—

1. obtaining information about the status of their radiation safety and security of activities and practices being conducted by a licensee;

   1. verifying compliance with the provisions of this Act and applicable regulations and conditions of licences;
       
   2. investigating any incident or accident involving nuclear material or radiation sources;
       
   3. questioning any person who has duties which, in the view of an inspector may be pertinent to the inspection being carried out or an enquiry being conducted;

4. taking samples in a prescribed manner, of any material and make such examinations and enquiries as may be necessary to ascertain whether the provisions of this Act, any other applicable written law, standards and guidelines are being complied with;

5. seizing any radioactive material or source which, on reasonable grounds, the inspector believes has not been authorized;

b. conducting inspections to assess radiation safety, security conditions and compliance with this Act, applicable regulations and other requirements specified in the licence; and

c. exercising such other powers as are necessary for carrying out the provisions of this Act into effect.

2. A licensee, either by himself, his servants, agents or otherwise shall not hinder or obstruct an inspector, from entry, inspection, examination, inquiring, taking of samples or otherwise in the exercise of his powers under this Act.

3. Except for an unannounced inspection, the Authority shall give reasonable notice to the licensee that an inspection is to be carried out.

40. DUTY OF INSPECTORS

—(1) An inspector shall document the inspection results in a report, which he shall submit to the Executive Director, within a prescribed time.

2. The Authority shall make the inspection results available to the licensee and any other entities as required.

3. The report referred to in subsection (1) shall be recorded and kept by the Authority.

41. COMPLIANCE ORDER

—(1)Where the Authority determines that a licensee is not in compliance with any condition of the licence, or is in contravention of any provision of this Act or applicable regulations, the Authority may, by notice in writing, direct the licensee to restore compliance.

(2) A notice under subsection (1) containing a direction to restore compliance shall be sent to the licensee, as may be required by the directly affected parties and shall—

(a) state the relevant condition or provision of this Act to which the contravention is related;

(b) contain clear reference to the findings, which constitute a contravention of the condition or provision;

(c) specify the period within which compliance shall be restored; and

(d) specify the period, not being less than fourteen days from the date of receiving the notice, within which representations or objections may be made by the licensee or directly affected parties.

(3) After the Executive Director has received representations as contemplated in subsection (2) (d), he may recommend to the Board to—

(a) uphold the order of compliance;

(b) vary the original order of compliance; or

(c) withdraw the order of compliance.

(4) Where the Board decides to uphold or vary the order, the Executive Director shall issue a notice to the licensee to whom the original order was directed—

(a) informing the licensee of the Board’s decision; and

(b) indicating the period, not being less than fourteen days, within which the licensee shall comply with the order.

42. COMPLIANCE ORDER IN URGENT MATTERS

—(1) The Executive Director may, after hearing the parties concerned, direct a licensee to take immediate action to discontinue or refrain from an activity or practice, where he is satisfied that the licensee is not complying with any condition of the licence, or is contravening any provision of this Act, and that immediate action is necessary to—

(a) protect the health of any person;

(b) prevent irreversible damage to the environment; or

(c) prevent serious damage to property.

(2) Where the licensee does not comply with a direction issued under subsection (1), the Executive Director may take any necessary action, to prevent any significant damage, on behalf of the licensee at the cost of the licensee.

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                     Part VII—

Radiation safety principles

43. FUNDAMENTAL PRINCIPLES

The following principles of radiation protection shall apply to all activities and practices conducted in the Republic of Malawi—

1. Justification: No activity or practice shall be licensed unless it produces sufficient benefit to exposed persons or to society in a manner that offsets the radiation harm that it may cause, taking into account social, economic and other relevant factors;

2. optimization: In relation to radiation exposures from any particular activity or practice, radiation protection measures shall ensure that doses, the number of persons exposed and the likelihood of incurring exposure is at all times kept as low as reasonably achievable taking into account social and economic factors; and

3. Dose Limitation: Activities and practices shall be conducted in a manner that ensures that the total dose that a person may experience does not exceed the dose limits established by the Authority, in accordance with international standards, so that no person is subject to an unacceptable risk attributable to radiation exposure.

44. REGULATORY CONTROL OF RADIATION SAFETY

—(1) Based on internationally recognized guidelines, the Authority shall adopt a categorization of sources based on the potential injury to the public, workers and the environment that may occur if such sources are not safely managed or securely protected.

2. The regulatory programme of the Authority, including the licensing and inspection system as prescribed in Part IV and Part VI, shall be based on the categorization of sources.

3. The Authority shall establish dose limits to persons, in accordance with international standards, and the limits shall not be exceeded in carrying out regulated activities.

4. The Authority shall identify sources or practices to be exempt from regulatory control based on the following criteria—

1. that the radiation risk for persons is sufficiently low to be of no regulatory concern;

2. that the collective radiological impact is sufficiently low that regulatory control is not warranted; and

3. that the activity sources or practice is considered to be inherently safe, with no likelihood of creating situations that could result in a failure to meet the criteria in paragraph (a) or (b).

5. The Authority shall establish clearance levels or values, within licensed activities below which radioactive material or radioactive objects within authorized activities and practices can be released from regulatory control.

PART VIII

MEDICAL PRACTICES

45. MEDICAL PRACTICES INVOLVING THE USE OF RADIATION SOURCES

Where medical practices involving the use of radiation sources, are carried out, the Authority shall prescribe, the following—

(a) the qualifications and training requirements for users;

(b) measures to protect persons using radiation sources;

(c) measures to protect patients, including the justification of practices and optimization of exposures;

(d) design and performance criteria for radiation producing equipment and devices containing radionuclides; and

(e) measures for the safety and security of radioactive sources.

46. PROTECTION OF PATIENTS

A person licensed to conduct medical practices shall ensure that no patient shall be administered with a dose due to a diagnostic or therapeutic procedure unless the exposure is prescribed by a medical practitioner who is assigned the primary task and obligations for ensuring overall patient protection and safety in the prescription of, and during the delivery of, medical exposures.

Part IX—

Emergency Preparedness and Response

47. REQUIREMENT FOR AN EMERGENCY PLAN

—(1) The Authority shall not grant a licence to conduct an activity or practice, unless and until an applicant has developed, and the Authority has approved, an emergency preparedness and response plan.

2. The Authority shall establish, by regulation or conditions prior to issuing a licence, where applicable, a requirement that the applicant prepares, and the Authority approves, on-site and off-site emergency plans for any facility, activity, practice or source that could give rise to a need for emergency intervention.

3. In the preparation of emergency plan the following shall be taken into account, inter alia—

1. an assessment of the nature, likelihood and potential magnitude of resulting damage, including the population and territory at risk from an accident, malicious act or incident; and

2. the results of any accident analyses and any lessons learned from experience or incidents and accidents that have occurred in connection with similar activities or practices.

4. The specific requirements of an emergency plan shall be prescribed by the Authority.

5. Preparation of emergency plans for facilities, activities, practices or sources that could involve significant nuclear or radiological damage shall be coordinated with all relevant emergency intervention or response organizations, including—

a. the Office of the President and Cabinet;

2. the Office of Commissioner for Disaster Preparedness, Relief and Rehabilitation;   

3. the ministry responsible for Defence;

4. the ministry responsible for Home Affairs;

5. the ministry responsible for Water Affairs;

6. the ministry responsible for Health;

7. applicable District Assemblies;

8. Malawi Meteorological Services; and

9. emergency services including fire brigades, hospitals and police services.

6. The licensee shall periodically review and update the emergency plan as prescribed by the Authority.

48. COMPLIANCE WITH EMERGENCY PLAN

In the event of a radiological emergency, a licensee shall implement the emergency plan as approved by the Authority.

49. NATIONAL PLAN FOR RADIATION EMERGENCIES

—(1) A national emergency plan for responding to potential radiological emergencies shall be developed and maintained by the Authority and approved by the Cabinet.

2. Review and approval of the emergency plan mandated under subsection (1) shall be done in consultation with—

1. the Office of the President and Cabinet;
    
2. the Office of Commissioner for Disaster Preparedness, Relief and Rehabilitation;
    
3. the ministry responsible for Defence;
    
4. the ministry responsible for Home Affairs;
    
5. the ministry responsible for Water Affairs;
    
6. the ministry responsible for Health;
    
7. applicable District Assemblies;
    
8. Malawi Meteorological Services; and
    
9. emergency services including fire brigades hospitals and police services.

3. The national radiological emergency plan may be coordinated with and take into account the provisions of—

1. the Disaster Preparedness and Relief Act;
    
2. the Disaster Risk Reduction Policy;
    
3. Operational Guidelines for Disaster Risk Management in Malawi; and
    
4. The country  Programme Action Plan, as revised from time to time.

4. The national radiological emergency plan shall include an allocation of responsibilities and actions among relevant public institutions and non-governmental organizations, including arrangements for communications and public information.

50. EMERGENCY WITH TRANS­BOUNDARY EFFECTS

In the event of a nuclear or radiological emergency occurring outside Malawi which may pose a risk of radioactive contamination spreading into Malawi, the Authority shall comply with relevant international instruments.

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Part X—

Radioactive Waste Management

51. PROHIBITION OF THE IMPORT OF RADIOACTIVE WASTE

Radioactive waste generated outside the territory of Malawi shall not be imported into Malawi for any purpose.

52. GENERAL PRINCIPLES

At all stages of the management of radioactive waste the following principles shall be applied by all persons and entities, including public institutions so that—

1. the public, workers and the environment are adequately protected against radiological and other hazards;

2. the generation of radioactive waste is kept to the minimum practicable;

3. the relationships among different steps in radioactive waste management are taken into account;

4. the protective measures for radioactive waste management are implemented in a manner that reflects internationally recognized criteria, standards and guidance specifically those adopted by the International Atomic Energy Agency;

5. the biological, chemical and other hazards that may be associated with radioactive waste management are adequately addressed;

6. the criticalness of removing residual heat generated during radioactive waste management is adequately addressed;

7. the actions imposing reasonably predictable impacts on future generations greater than those permitted for the current generation are avoided; and

8. the undue burdens on current and future generations are avoided.

 53. REGULATIONS ON RADIOACTIVE WASTE MANAGEMENT

 —(1) The Minister, on the recommendation of the Authority, may make regulations prescribing the manner of safe management and storage and discarding of radioactive waste.

2. To ensure the safe and secure management of radioactive waste in Malawi, the Authority shall establish—

1. applicable safety and security requirements and regulations for the protection of the public, workers and the environment from adverse impacts of radioactive waste and spent fuel management activities;

2. a system of licensing of radioactive waste management activities;

3. a system of institutional control, regulatory inspection and documentation and reporting for radioactive waste management activities; and

4. a system of enforcement to ensure compliance with applicable regulations and the terms and conditions of licences for radioactive waste management activities.

54. LICENCE REQUIREMENT FOR RADIOACTIVE

A person or entity shall not operate a radioactive waste management facility without a licence issued by the Authority.

55. RESPONSIBILITY FOR SAFETY AND SECURITY OF RADIOACTIVE WASTE

—(1) The primary responsibility for ensuring the safety and physical protection of a radioactive waste inside or outside a radioactive waste management facility throughout its life shall rest with the relevant licensee.

(2) The responsibility for ensuring the safety and physical protection of radioactive waste for which no licensee nor an entity can be determined shall rest within the Authority.

56. DISPOSAL PLAN

—(1) A licensee of a radioactive waste management facility shall prepare a plan for the closure of the facility that includes both active and passive institutional controls.

(2) The licensee shall submit to the Authority the plan referred to in subsection (1) for approval prior to the commencement of the operation of the facility.

57. EXPORT OF RADIOACTIVE WASTE

Radioactive waste generated within the country may be exported only upon the issuance of a licence by the Authority.

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Part XI—

Transportation of Radioactive Material

58. REQUIREMENT FOR A LICENCE TO TRANSPORT RADIOACTIVE MATERIAL

—(1) A person nor an entity shall not engage in the transportation of radioactive material without a licence.

2. Any transportation of radioactive material shall be carried out in compliance with national standards and applicable written law, and the technical requirements of the Regulations for the Safe Transport of Radioactive Material of the international Atomic Energy Agency, as amended from time to time.

3. The license shall have the primary responsibility for ensuring the safety and security of the radioactive material during transportation.

59. REGULATIONS ON TRANSPORTATION OF RADIOACTIVE MATERIAL

—(1) The Authority shall establish requirements for the transportation of radioactive materials to, from and within the country.

2. The requirements adopted pursuant to this section shall take into account the technical requirements of the latest edition of the Regulations for the Safe Transportation of Radioactive materials issued by the International Atomic Energy Agency.

3. The requirements adopted pursuant to this section shall include measures for the physical protection of radioactive material consistent with guidance documents issued by the International Atomic Energy Agency.

Part XII—

Mining and Processing

60. LICENCE FOR MINING AND PROCESSING RADIOACTIVE MINERALS

—(1) A person nor an entity shall not engage in mining and processing of radioactive minerals without a licence issued by the Authority.

2. The Authority shall establish requirements for granting a licence to conduct mining and processing activities involving materials that could pose risks from exposure to ionizing radiation, including the following—

1. any exploration activity involving possible exposure to radiation;

2. removal of radioactive minerals from the site for testing or evaluation, unless exempt;

3. excavation activities at a site, including a test mine, for evaluation or delineation of the ore body;

4. siting, construction or operation of a mine or processing facility;

5. temporary storage, transportation and export of the product of mining or milling activities;

6. radioactive waste management;

7. rehabilitation of the mining site; and

8. decommissioning or closure of a mine or processing facility.

3. The Authority shall establish a system of monitoring and inspection to verify compliance with this Act, applicable regulations and any licences issued pursuant to this section.

—(1) Nuclear material in Malawi shall be used exclusively for peaceful nuclear activities and in accordance with relevant international obligations undertaken by Malawi.

2. A person shall not engage in any activity involving nuclear material unless previously and specifically licensed by the Authority.

3. A person shall not engage in the import or export of nuclear material or of other specified equipment and non-nuclear material, without a licence issued by the Authority.

4. A person shall not carry out research and development activities which are related to the nuclear fuel cycle regardless of whether the activities involve nuclear material, unless such person has informed the Authority in writing and has obtained a licence prior to the commencement of the activities.

5. Any person performing activities subject to the Safeguards Agreement shall submit to the Authority the information and data necessary for compliance with the undertakings arising from such instruments.

67. PROHIBITED ACTIVITIES

—(1) The uses of nuclear energy and ionizing radiation in Malawi shall be for peaceful purposes only.

2. Any activities or practices related to the acquisition or development of nuclear explosives, radiological dispersal devices, or other non-peaceful uses of nuclear or other radioactive materials and related technology or assisting others in such activities are strictly prohibited.

3. Any person who contravenes subsection (2) commits an offence and shall, upon conviction, be liable to life imprisonment.

68. APPLICATION 0F SAFEGUARDS

1. To ensure compliance with the commitments of Malawi pursuant to the Treaty on the Non-Proliferation of Nuclear Weapons and the Treaty of Pelindaba, the International Atomic Energy Agency shall have the right to apply safeguards as provided for in the Safeguards Agreement and Additional Protocol thereto between Malawi and the International Atomic Energy Agency.

(2) The Authority shall be the organizer and coordinator for implementing the obligations of Malawi arising from the Safeguards Agreement.

(3) The Authority shall—

(a) verify the implementation of the obligations of Malawi arising from the Treaty, to prevent diversion of nuclear material to the manufacturer of nuclear weapons;

(b) collect and provide to the International Atomic Energy Agency the information required to fully implement the Safeguards Agreement, including information resulting from the conduct of verification of activities provided for in the Safeguards Agreement and the Additional Protocol thereto;

(c) provide for inspections within the territory of Malawi by inspectors of the International Atomic Energy Agency, including provision of access; and

(d) coordinate with the ministry responsible for foreign affairs in connection with the provision of information regarding the Safeguards Agreement.
 

69. COOPERATION IN THE IMPLEMENTA­TION OF SAFEGUARDS

—(1) The Government, all public institutions and licensees shall cooperate fully with the International Atomic Energy Agency in the implementation of safeguards, including by—

(a) promptly providing any information required pursuant to the Safeguards Agreement and the Additional Protocol thereto;

(b) providing access to facilities and other locations as required by the Safeguards Agreement and the Additional Protocol thereto;

(c) cooperating with and facilitating the performance of International Atomic Energy Agency inspectors in their tasks; and

(d) rendering the necessary services as requested by International Atomic Energy Agency inspectors.

(2) The duly authorized representatives and designated inspectors of the Atomic Energy Regulatory Authority shall have access to any facilities or other locations provided for under the Safeguards Agreement and the Additional Protocol thereto, with a view to con­ducting the verification activities authorized by the Safeguards Agreement and the Additional Protocol thereto.

(3) Any person performing AcOimiC-fneub ect to the Safeguards Agreement and the Additional Protocol thereto shall be obliged to allow the duly authorized representatives and designated inspectors of the International Atomic Energy Agency to carry out any measures the International Atomic Energy Agency considers necessary or appropriate to ascertain compliance by Malawi with its undertakings, arising from the Safeguards Agreement and the Additional Protocol thereto.

Part XIV—

Offences and Penalties

70. OFFENCES RELATING TO LICENCES

 (1) Any person who carries out an activity or practice without a licence issued by the Authority under this Act, commits an offence and shall, upon conviction, be liable to fifteen years imprisonment.

2. In addition to the penalties provided in subsection (1), the radioactive material or source shall be liable, pursuant to a court order, to seizure, impoundment, sealing, seizure of operation, destruction or disposal in such a manner as the court may consider necessary to protect the public and the environment and may only be returned to the original owner on the order of the court and under such conditions set out in the licence issued under this Act.

71. HINDERING AND OBSTRUCTING OF INSPECTORS

Any person who—

1. hinders or obstructs an inspector in the execution of his duties under this Act;

2. fails to comply with a lawful order or requirement made by an inspector in accordance with this Act;

3. prevents the Executive Director or an inspector or any person duly authorized by the Executive Director from gaining entry upon or into any premises which he is empowered under this Act to enter;

4. impersonates the Executive Director or an inspector or any person duly authorized by the Board;

5. prevents an inspector from having access to any record or document required by the inspector for purposes of this Act;

6. misleads or intentionally gives false information to the Executive Director or an inspector or any person duly authorized by the Board under this Act; or

7. fails to comply with measures directed by the Authority, the Executive Director or any inspector for the protection and management of the environment and the conservation and sus­tainable utilization of natural resources, commits an offence shall  upon conviction be liable, to a fine of two million Kwacha (K2,000,000) and to fifteen years imprison­ment; and in addition shall, for each day the offences continue shall be liable to a fine of ten thousand Kwacha (K10, 000).

72. OFFENCES RELATING TO RECORDS

Any person who—

(a) fails to keep or furnish the Authority with records required under this Act or under any regulations made under this Act; or

(b) fraudulently or knowingly alters any such records, commits an offence and shall, upon conviction be liable, to a fine of five hundred thousand Kwacha (K500,000) and to two years imprisonment.

73. PROHIBITION OF DISCLOSURE OF INFORMATION BY EMPLOYEE OF AUTHORITY

—(1) Every person employed by the Authority shall not disclose any information obtained by him in the course of his duties and in the exercise of any of the powers conferred by this Act;

(2) Any person who violates this provision, regardless of whether such person has ceased to be employed by the Authority, commits an offence and shall, upon conviction, be liable to fifteen years imprisonment.

74. HANDLING OF RADIOACTIVE OR NUCLEAR MATERIAL AND DEVICES

(1) Any person who, without lawful authority, receives, possesses, transfers, alters, or disposes of, radioactive or nuclear material or a device—

1. with the intent to cause—

1. death or serious bodily injury; or

2. substantial damage to property or to the environment; or

2. which causes or is likely to cause death or serious injury to any person or substantial damage to property or to the environment, commits an offence and shall, upon conviction be liable, to thirty years imprisonment.

(2) Any person who is involved in—

1. theft or robbery of radioactive or nuclear material;

2. embezzlement or fraudulently obtaining radioactive or nuclear material; or

3. an act which constitutes the carrying, sending, or moving of radioactive material into, within or out of Malawi without lawful authority, commits an offence and shall, upon conviction be liable, to thirty years imprisonment.
   
   (3) Any person who threatens to committee an offence set forth in subsection (2) (a) in order to compely natural or legal person, international organization or state to do or to refrain from doing any act, commits an offence and shall, upon conviction, be liable to life imprisonment.

2. Any person who demands radioactive or nuclear material or a device by threat, or by use of force, or by any other form of intimidation, under circumstances which indicate the credibility of the threat, commits an offence and shall, upon conviction be liable to thirty (30) years imprisonment.

75.  USE OF RADIOACTIVE OR NUCLEAR MATERIALS

 (1) Any person who, without lawful authority, uses or disperses in any way radioactive or nuclear material or uses or makes a device—

1. with the intent to cause—

1. death or serious bodily injury; or

2. substantial damage to property or to the environment;

2. to compel a natural or legal person, an international organization, or a state to do or refrain from doing an act; or

3. which causes or is likely to cause death or serious injury to any person or substantial damage to property or to the environment, commits an offence and shall, upon conviction, be liable to life imprisonment.

(2) Any person who threatens to commit the offence set forth in subsection (1), commits an offence and shall, upon conviction, be liable to life imprisonment.

76. GENERAL OFFENCE AND PENALTY

Any person who carries out an activity or practice in contravention of the provisions of this Act commits an offence, and if no other penalty is provided for, shall, upon conviction, be liable to fifteen years imprisonment.

77. EXTRADITABLE OFFENCES

The offences set forth in this Part shall be considered as extraditable offences, subject to the written laws and procedures of Malawi.

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Part XV—

Appeals

78 _ APPEAL PROCEDURE

 (1) Any person aggrieved by a decision made pursuant to this Act, including a decision to issue a licence, may appeal to the Board not later than thirty days after the notification of such refusal.

(2) Where an appeal is made under subsection (1), the Executive Director shall give all relevant information to the Board as the Executive Director considers necessary to enable the Board to determine the appeal.

(3) any person aggrieved by the decision of the Board may appeal to the Minister within thirty days after the Board makes its decision.

(4) The Board or the Minister, as the case may be, in determining the appeal may recommend to the Executive Director or the Board, as the case may be, to review his or its decision.

(5) Any person who is aggrieved by the decision of the Minister to uphold the decision of the Board under subsection (3) may apply to the High Court for judicial review within thirty days of the receipt of the notification of the Minister’s decision.
 

Part XVI—

Miscellaneous Provisions

79. INDEMNIFICATION

No legal proceedings shall be brought against the Executive Director, an inspector, or any other person duly authorized by the Authority, the Executive Director, or inspector to do anything authorized under this Act, in respect of anything done in good faith under the provisions of this Act.

80. CONFIDENTIALITY OF SOURCES OF INFORMATION

The Authority shall establish a policy on confidentiality of information provided to it.

81. OFFENCES BY CORPORATE BODIES

Any act or omission, which if done by an individual is an offence under this Act or any regulations made under it, shall, if done by a body corporate, be deemed an offence committed by every director, secretary or manager, unless the director, secretary or manager proves that the offence was committed without their consent, knowledge or connivance and that the director, secretary or manager exercised all due diligence to prevent the commission of the offense as the director, secretary or manager ought to have exercised, having regard to the nature of their functions and all circumstances of the case.

82. REGULATIONS

 (1) The Minister may, on recommendation of the Authority, make regulations for the better carrying out of the provisions of this Act.

(2) Without prejudice to the generality of subsection (1), the regulations made under this section may—

1. prescribe the application and licence forms to be used under this Act;
    
2. limit the use of radioactive material or equipment producing harmful ionizing radiation for any specific purpose, including use of medical or dental purposes;
    
3. prescribe fees for services rendered by the Authority; and
    
4. prescribe anything required to be prescribed under this Act.

(3) Any regulation made under this Act may, notwithstanding the provisions of section 21 (e) of the General Interpretation Act, Cap. 101 prescribe a fine of up to five million Kwacha (K5,000,000) and imprisonment for up to five years for contravention of any provision of such regulation.

83. Transitional provisions
_ (1) Any person conducting an activity or practice within the Transitional scope of this Act at the time this Act enters into force, shall inform the Authority, submit a notification to, or where applicable, apply for a licence as required under this Act, within two months of the entry into force.

2. Upon entry into force of this Act, the Authority shall review, within three months, the results of past activities or practices in order to determine whether any intervention is needed to ensure that remedial or protective action is taken to protect the public, workers and the environment.

3. Any person conducting any activity or practice governed by this Act, pursuant to an authorization granted under any relevant written law, at the time this Act enters into force, shall, subject to subsection (2), be considered as having been granted a temporary authorization.

4. Any person considered as having been granted such a temporary authorization shall take all necessary measures to bring such activities or practices in line with provisions of this Act, within three months after its entry into force.

5. Any person to whom subsection (1) applies shall pay the applicable prescribed fees to the Authority.

Passed in Parliament this thirty first day of May, two thousand and eleven.

M. M. Katopola
Clerk of Parliament

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311

Part I—

Preliminary

1. Citation
2. Interpretation

Part II—

General Provisions

3. Purpose

4. Scope

5. Application

6. Exposures

7. Exclusions

8. Responsible parties

9. Access to premises and information

10. Non-compliance, incidents and accidents

11. Enforcement

12. Applicability of other regulations and requirements, and resolution of conflicts

13. Additional requirements

14. General obligations

Part III—

Administrative Requirements

15. Requirements for notification
16. Exemption of practices and sources
17. Requirements for licence
18. Responsibilities of licensees
19. Requirements for reporting to the Authority
20. Feedback of operating experience
21. clearance levels

Part iv

Radiation Protection Requirements

22. Justification of practices
23. Dose limitation
24. optimization of protection and safety
25. Dose constraints
26. Guidance levels for diagnostic medical exposure

Part v

Management Requirements

27. Safety culture

28. confidentiality of information

29. Management system Regulation

30. Human factors

31. Radiation protection officers and qualified experts in radiation safety    31st August, 2012

Part vi—

Verification of Safety

32. Safety assessment
33. Monitoring, testing and verification of compliance
34. Inventory and records

Part vii—

Occupational Exposure Protection

35. General responsibilities
36. Conditions of service
37. Classification of areas
38. Local rules and supervision
39. Personal protective equipment
40. Exposure assessment
41. monitoring of workplace
42. Health surveillance
43. Records of worker exposure
44. Special circumstances

Part viii—

Medical Exposure Protection

45. General responsibilities
46. Justification of medical exposure
47. Optimization of protection for medical exposures
48. Calibration, clinical dosimetry and management system for medical exposures
49. Dose constraints
50. Guidance levels
51. Maximum activity for patients in therapy and discharge from hospital
52. Investigation of accidental medical exposure
53. Records related to medical exposures

Part ix—

Public Exposure Protection

54. General responsibilities
55. Control of visitors
56. Sources of external irradiation
57. Radioactive contamination in enclosed spaces
58. monitoring of public exposure
59. Consumer products

Part x—

Requirements for the Design, Protection and Supply of Radiation Sources

60. General responsibilities
61. Design of radiation sources
62. Supply and procurement of radioactive sources
63. Domestic transfer of radiation sources

Part xi—

Import and Export of Category 1 and 2 Radioactive Sources

64. Export of category 1 or 2 radioactive sources
65. Import of category 1 and 2 radioactive sources

Part xii—

Radioactive Waste Management Requirements

66. Radioactive waste classification
67. General responsibilities
68. Licence application
69. Appointment of radioactive waste management officer
70. Control of radioactive waste generation
71. Collection, segregation, and characterization of radioactive waste
72. Conditioning of radioactive waste
73. Radioactive waste processing facilities
74. Discharge or release of radioactive materials to the environment
75. Waste storage
76. Acceptance criteria for storage of radioactive waste
77. Radioactive waste storage facilities
78. Recycle and reuse of radioactive materials
79. Management of disused radioactive sources
80. Radioactive waste from mining and milling operations
81. Existing facilities and past practices
82. Radioactive waste records and reports

Part xiii—

Decommissioning Requirements

83. Decommissioning
84. Decommissioning plan

Part xiv—

Transportation of Radioactive Sources or Waste

85. Transport requirements

Part xv—

Requirements for Emergency Intervention

86. Responsibilities of licensees
87. Licensee emergency response planning requirements
88. implementation of intervention
89. Protection of workers undertaking an intervention
90. Use of international safety standards and other publications

schedules

first schedule       Form for Notification of Practices and Sources

second schedule   Dose Limits for Exposures Incurred from Practices

third schedule      Medical Exposure Design and Operational Requirements

fourth schedule  Categorization of Radioactive Sources

 fifth schedule     Fees for Practices involving the use of atomic energy

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In Exercise of the powers conferred by section 82 of the Atomic Energy Act, I Catherine Gotani Hara, Minister of Environment and Climate Change Management , on the recommendation of the Atomic Energy Board, make the following Regulations—

Part I—

Preliminary

1. Citation

These Regulations may be cited as Atomic Energy Regulations, 2012.

2. interpretation

In these Regulations, unless the context otherwise requires—

“category 1, 2 or 3 radioactive source” means the International Atomic Energy Agency Categorization of Radio Active Sources contained in the Fourth Schedule;

“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 pathway and is typical of individuals receiving the highest effective dose or equivalent dose, as applicable from the given source;

“defence in depth” means a hierarchical deployment of different levels of diverse equipment and procedures to prevent the escalation of anticipated operational occurrences and to maintain the effectiveness of physical barriers placed between a radiation source or radioactive material and workers, members of the public or the environment, in operational states and, for some barriers, in accident conditions;

“disused radioactive source” means radioactive source which is no longer used, and is not intended to be used, for the practice for which a licence is granted;

“dose constraint” means a prospective and actual source related restriction on the individual dose delivered by the source which serves as a bound in the optimization of protection and safety of the source. for occupational exposures, the dose constraint is a source related value of individual dose used to limit the range of options considered in the process of optimization. for public exposure, the dose constraint is an upper bound on the annual doses that members of the public should receive from the planned operation of any controlled source. The dose to which the dose constraint applies is the annual dose to any critical group, summed over all exposure pathways, arising from the predicted operation of the controlled source. The dose constraint for each source is intended to ensure that the sum of doses to the critical group from all controlled sources remains within the dose limit. for medical exposure the dose constraint levels should be interpreted as guidance levels, except when used in optimizing the protection of persons exposed for medical research purposes or of persons, other than workers, who assist in the care, support or comfort of exposed patients;

“exemption level” means a value, established by the Authority and expressed in terms of activity concentration, total activity, dose rate or radiation energy, at or below which a source of radiation may be granted exemption from regulatory control without further consideration;

“legal person” means any organization, corporation, partnership, firm, association, trust, estate, public or private institution, group, political or administrative entity or other persons designated in accordance with national legislation, who or which has responsibility and authority for any action having implications for protection and safety;

“management” means the administrative and operational activities that are involved in the manufacture, supply, receipt, possession, storage, use, transfer, import, export, transport, maintenance, recycling or disposal of radioactive sources;

“principal parties” mean the persons having the main responsibilities for the application of these Regulations, including registrants, licensees and employers;

“orphan radioactive source” means radioactive source which is not under regulatory control because it has never been under regulatory control, or because it has been abandoned, lost, misplaced, stolen, or transferred without a proper licence;

“registration” means a form of licence for practices of low or moderate risks whereby the legal person responsible for the practice has, as appropriate, prepared and submitted a safety assessment of the facility and equipment to the Authority. The practice or activity is licensed with conditions or limitations, as appropriate;

“regulatory control” means any form of control or regulation applied to facilities or activities by an Authority for reasons related to radiation protection or to the safety of radiation sources;

“safety culture” means the assembly of characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, protection and safety issues receive the attention warranted by their significance;

“spent radioactive source” means radioactive source that is no longer suitable for its intended purpose as a result of radioactive decay;

“storage” means the holding of radioactive sources, spent fuel or radioactive waste in a facility that provides for its containment, with the intention of retrieval;

“vulnerable radioactive source” means radioactive source for which control is inadequate to provide assurance of long term safety and security, such that it could relatively be easily acquired by unlicensed persons or could, relatively easily become orphaned.

Part II

General Provisions

3. Purpose

—(1) These Regulations specify the basic requirements:

1. for the protection of people against exposure to ionizing radiation, for the safety of radiation sources, for the safety of radioactive waste management, and for the protection of the environment, (hereinafter referred to as “protection and safety”) and;

(b) to prevent unlicensed access or damage to, and loss, theft or unlicensed transfer of radioactive sources, so as to reduce the likelihood of accidental harmful exposure to such sources.

(2) These Regulations shall not relieve a licensed legal person from the duty to take any additional actions as may be appropriate and necessary to protect the environment or the health and safety of people.

4.Scope

--these regulations shall apply to the adoption, introduction, conduct, discontinuance, or cessation of a practice and to the design, manufacture, construction or assembly, acquisition, import or export, distribution, selling, loaning or hiring, locating, commissioning, processing, possession, use and operation, maintenance or repair, transfer or decommissioning, disassembly, transport, storage and recycling or disposal of a radiation source within a practice unless exposure from the source is specifically excluded under regulation 7 or is exempted under regulation 16.

5. Application

(1) the sources within any practice to which the requirements for practices of these regulations shall apply include—

1. radioactive materials and devices that contain radioactive material, produce radiation or nuclear material, including consumer products, sealed radioactive sources, unsealed sources, and radiation generators;

2. installations and facilities containing radioactive materials or devices containing radioactive material or that produce radiation which are used for industrial, medical, agricultural, research and education purposes;

3. radioactive waste resulting from applications and to radioactive waste management facilities and activities including;

4. effluent discharges;

2. waste that contains only naturally occurring materials, whatever the origin of that waste;

3. disused radioactive sources; and

4. any other radiation source specified by the Atomic Energy regulatory Authority, including sources in the environment such as radon.

2. the specific radioactive waste provisions contained in regulations 74 78 shall apply only to waste arising from medical, agricultural, industrial, research and education applications, mining and milling activities, including associated radioactive waste management activities, such as collection, segregation, characterization, classification, treatment, conditioning, and storage.

3. these regulations shall apply to intervention by legal persons licensed to possess radiation sources in the event of radiological emergencies involving their sources.

6. Exposures

The exposures to which the safety requirements of these Exposures Regulations apply are any occupational exposure, medical exposure or public exposure due to any relevant practice or radiation source within the practice, including both normal exposures and potential exposures.

7 Exclusions

. the following exposures are excluded from the application of these exclusions regulations—

1. exposures from natural radioactivity in the body;

2. cosmic radiation;

3. unmodified concentrations of natural radionuclides in raw materials; and

4. any other radiation sources that is essentially unamenable to control as may be determined by the Authority.
   
   8 Responsible parties
   
   . —(1) the principal parties which have the main responsibilities for the responsible application of these regulations shall be—                             

1. legal persons responsible for notified or licensed practices or sources within practices; and

2. employers of workers who do not report directly to legal persons.
   
   
   2. --other parties which shall have subsidiary responsibilities for the application of these regulations may include, as appropriate;

1. suppliers;

2. workers;

3. radiation protection and waste safety officers;

4. medical practitioners;

5. health professionals;

6. qualified experts;

7. ethical review committees; and

8. any other party to whom the principal party has delegated specific tasks.
   
   3. the general responsibilities of the principal parties include—

1. to establish radiation safety objectives, to protect people and the environment from the harmful effects of ionizing radiation, in conformity with the relevant requirements of these regulations;

2. to develop, implement and document a radiation safety programme commensurate with the nature and extent of the risks associated with the practices and interventions under their responsibility and sufficient to ensure compliance with the requirements of these regulations and in particular, this programme shall include the following actions—

1. to determine and continually review the measures needed to achieve the radiation safety objectives, to ensure that resources needed for their implementation are provided and regularly to verify that radiation safety objectives are being achieved;

2. to identify and prevent, or promptly correct, any failures or shortcomings in the radiation safety measures;

3. to facilitate consultation and co-operation among all relevant parties with respect to radiation safety; and

4. to keep appropriate records regarding the discharge of their responsibilities; and

3. to ensure that—
   
   i. radioactive sources are managed in accordance with the licence;

2. when radioactive sources are not in use, they are safely stored;

3. any transfer of sources to another person is licensed and documented and that the receiving person or entity is licensed in accordance with the applicable regulatory requirements to receive the transferred source;

4. arrangements are made for the safe management of radioactive sources (minimum category 1, 2 & 3 as referred to in the Fourth Schedule), including financial provisions where appropriate, once they have become disused;

5. the import and export of category 1 & 2 radioactive sources is done in accordance with these Regulations;

6. sources are shipped and received in accordance with regulatory requirements; and

7. assistance is provided to relevant authorities or law enforcement authorities in recovering any lost or stolen source.

9. Access to premises and information

(1) Legal persons responsible for notified or licensed practices or sources within practices shall permit representatives of the Authority immediate access to premises and facilities in which such practices are conducted or sources located in order to obtain information about the status of radiation safety and verify compliance with regulatory requirements.

2. Each legal person engaged in a practice to which these regulations apply, shall make available to the Authority, information and records regarding radiation safety and security of sources as required.

10. Non­compliance, incidents and accidents

(1) In the event of a breach of any applicable requirement of these regulations, principal parties shall, as appropriate—

1. investigate the breach and its causes, circumstances and consequences;

2. take appropriate action to remedy the circumstances and to prevent a recurrence of similar situations;

3. report to the Authority within twenty-four (24) hours, or as required, on the causes of the breach, its circumstances and consequences, and on the corrective or preventive actions taken or to be taken; and

4. take whatever other actions are necessary as required by these Regulations.

2. Whenever a situation involving the loss of control through loss or theft of a category 1, 2 or 3 radioactive source has occurred or is occurring, the Authority shall be informed as soon as it is discovered that there has been a loss of control of the category 1, 2 or 3 radioactive source.

3. Failure to take corrective or preventive actions within a reasonable time in accordance with these Regulations shall be grounds for enforcement in accordance with regulation 11.

11. Enforcement

—(1) The Authority may revoke, suspend or modify a licence to use a radiation source where the Authority finds that there is an undue threat to health and safety or non-compliance with the Act or other applicable regulatory requirements.

2. Where the Authority finds that legal persons responsible for notified or licensed practices or sources within practices have not complied with the Act, applicable regulations and regulatory requirements commensurate with the nature of the infraction, the Authority shall impose upon them the prescribed fines.

3. the Authority shall refer any wilful violations or attempted violations of these regulations or requirements to the Director of Public Prosecutions for prosecution.

4. Any person who contravenes any provision of these regulations commits an offence and shall, upon conviction, be liable to a fine of five million Kwacha and to five (5) years imprisonment.

12. Applicability of other regulations and requirements,

—(1) the requirements of these regulations are in addition to, and not in place of, other applicable national and international laws and regulations.

2. Nothing in these regulations shall be construed as—

1. relieving employers from complying with applicable national and international laws and regulations governing safety and security of sources; or

2. restricting any actions that may otherwise be necessary for safety and security of sources.

3. Where a conflict exists between requirements contained in these regulations and other laws or regulations, the Authority shall be notified of the conflict in order to initiate steps towards resolution.

13. Additional requirements

—(1) the Authority may prescribe other requirements by order, or conditions of a licence, in addition to those established under these regulations, as considered necessary to—

1. protect the public;

2. protect the environment; or

3. minimize risk from radiation hazards.

2. A licensed legal person shall comply with the additional requirements referred to in subregulation (1).

3. except as specifically licensed, no official interpretation of these regulations binding on the Authority can be made by any officer or employee of the Authority other than a written interpretation by the executive Director of the Authority.

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Part III

Administrative Requirement

14 General obligations

—(1) A person shall not engage in activities, which

involve radioactive waste, practices or radiation sources as specified in regulation 4, unless the requirements of these Regulations, including requirements of notification and licence, are fulfilled.

(2) An applicant and a licensee, as the case may be, shall pay the applicable fees contained in the fifth schedule as prescribed by the Minister from time to time.

3. The Authority shall determine the formula to calculate the applicable fees, and the authority may, from time to time, review the formula.

15 Requirements For notification

—(1) Unless exempt from notification as provided for in regulation 16 (1) or (3), any legal person—

1. who, on the day these Regulations enter into force, is responsible for a practice or in possession of a radioactive source referred to in regulation 4, shall submit a notification to the Authority within ninety (90) days from the effective date and shall provide the information in the notification, specified in the First Schedule hereto; and

2. who intends to initiate a practice or to possess a radiation source referred to in regulation 4, shall submit a prior notification to the Authority of the intention.

(2) After notification, each legal person who is required to apply to the Authority for a licence and who submits such an application in accordance with regulation 17, may continue with the existing activities specified in the notification, in conformity with the applicable requirements of these Regulations, until the Authority revokes the permission or grants the licence.

16 Exemption of practices and sources

—(1) The Authority may exempt practices and sources within a practice from the specific safety requirements specified under these Regulations:

Provided that they comply with exemption levels defined by the Authority.

2. Exemptions shall not be granted for practices considered not to be justified as specified in regulation 22 (2) and regulation 46 (4).

3. the following practices and sources within a practice are automatically exempt from the specific safety requirements of these Regulations, including the requirements for notification, registration or licensing—

1. the radioactive materials for which the total activity of a given nuclide present on the premises at any one time or its activity concentration contained in a mass of one thousand kilograms (1000 kg) or less of material does not exceed the exemption levels; or

2. the apparatus containing radioactive material exceeding the quantities or concentrations specified above:

Provided that—

1. it is of a type approved by the Authority; and

2. it is constructed in the form of a sealed radioactive source, and it does not cause, in normal operating conditions, a dose rate exceeding 1 pSv-h^-1 at a distance of 0.1 m from any accessible surface of the apparatus nor a dose to any member of the public exceeding 10 pSv in a year; or

3. the operation of any electrical apparatus to which these Regulations apply, other than that referred to in (d) below:

Provided that—

1. it is of a type approved by the Authority; and

1. it does not cause in normal operating conditions a dose rate exceeding 1 pSv-h^-1 at a distance of 0.1 m from any accessible surface of the apparatus; or

4. the operation of any cathode ray tube intended for the display of visual images or other electrical apparatus operating at a potential difference not exceeding 30 kV:

Provided that it does not cause in normal operating conditions a dose rate exceeding 1 pSv-h^-1 at a distance of 0.1 m from any accessible surface of the apparatus.

17. Requirements for licence

—(1) Except as provided in regulations 15 and 16, a legal person who wishes to engage in a practice or possess a radiation source referred to in regulation 3, shall apply to the Authority for a licence and shall pay the fees prescribed in the fifth schedule.

2. In the case of existing practices or sources for which notification is made in accordance with regulation 15 (1) (a), such application shall be submitted within ninety (90) days.

3. Where the application is in respect of—

1. an industrial irradiation installation;

2. an installation processing radioactive materials;

3. a medical facility;

4. industrial radiography facility; or

5. is for any use of source that the Authority has not designated as suitable for registration from the date these Regulations enter into force, the application shall be in respect of a licence.

4. Any legal person applying for a licence, shall—

1. submit to the Authority relevant information necessary to support the application, including—

1. an evaluation of the nature, magnitude and likelihood of the exposures attributed to the practice and sources within the practice;

2. a safety assessment, in cases where this is prescribed by the Authority, to be submitted as part of the application;

3. an emergency plan, if applicable;

4. a determination of the characteristics and activity of any radioactive material to be discharged to the environment with an assessment of the resulting doses to the critical group; and

5. a final disposal solution for generated radioactive waste and disused sealed sources according to the agreed national policy and strategy;

2. take all necessary steps for the protection and safety of—

1. Workers;

2. Members of the public; and

3. Where applicable, patients; and

3. ensure the availability of human and financial resources for decommissioning of the facility and the management of radioactive waste.
   
   5. Applications for licences involving category 1, 2 or 3 radioactive sources shall include a description of the arrangements for the safe management of the source, including financial provisions where appropriate, once they have become disused.

6. The applicant shall clearly identify any information in the application which needs to be kept confidential in accordance with regulation 28.

7. Any legal person responsible for a source to be used for medical exposure shall include in the application for a licence, the qualifications in radiation protection of the medical practitioners, who shall be designated by name or by qualification credentials, in the licence as the only individuals permitted to prescribe medical exposure by means of the licensed source.

18. Responsibili­ties of licensees

 (1) A licensee shall bear the responsibility of establishing and implementing the administrative and technical measures that are necessary for ensuring protection and safety for both the practices and sources for which they are licensed; and for compliance with all applicable requirements of these regulations.

2. The licensee may appoint and shall specifically identify other persons to carry out actions and tasks related to the responsibilities, referred to in subregulation (1) but shall retain the responsibility for the actions and tasks themselves.
 

3. The licensee shall notify the Authority of his intentions to introduce modifications to any practice with a radiation source for which he is licensed where the modifications may have significant implications for safety, and the licensee shall not carry out any such modification unless specifically authorized by the Authority.

4. the licensee shall in an application to the Authority—

1. designate by name or qualifications any person who has key assignments related to safety; and

2. specify other workers assigned tasks in the handling and operation of radiation sources that may substantially affect protection and safety.

5. the licensee shall ensure that only workers referred to in sub-regulation. are permitted to fulfill such required assignments and tasks referred to in sub-regulation (4).

6. the licensee shall ensure that such persons meet the requirements for training specified in these Regulations.

7. the licensee 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, and technical and scientific developments;

2. are supported by reliable managerial and organizational features; and

3. include adequate margins in the design, construction and operation of sources.

8. the licensee shall ensure that the appropriate safety and security measures are in place and taken during the entire life cycle of radiation sources, from the moment of their manufacturing up to their final disposal.

9. For this purpose, the licensee 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 sources under his responsibility such that a failure at one layer is compensated for or corrected by subsequent layers, for the purposes of—

1. preventing accidents that may cause exposure;

2. mitigating the consequences of any accident should it occur; and

3. restoring sources to safe conditions after any accident.

10. the licensee shall ensure that the safety of the facility or of the waste shall not be jeopardized by any provision made for the purpose of complying with national or international requirements concerning safeguards of the material.

19. Requirements for reporting to the Authority

—(1) A licensee shall—

1. notify the Authority by telephone or facsimile as soon as practicable, but in any case not later than twenty-four (24) hours after discovery of any accident or incident which has the potential for, or has resulted in, serious injury or death of a patient, or which involves more than one patient in accordance with regulation 51;

2. submit to the Authority, within seven (7) days after discovery of the accident or incident, a written report which states the cause of the accident or incident and includes information on the doses, corrective measures and any other relevant information;

3. report a summary of the public exposure monitoring results to the Authority as prescribed and promptly inform the Authority of any abnormal results which lead or could lead to an increase of public exposure;

4. report discharges of radioactive waste into the environment to the Authority at intervals as may be specified in the licence and promptly report any discharges exceeding the licensed limits; and

5. report promptly, but in any case not later than twenty-four (24) hours and within seven (7) days, submit a written report to the Authority of any releases of radioactive material into the environment above the clearance criteria established by the Authority.

2. In addition to the radiation safety related reports above, the licensee shall make the following reports to the Authority—

1. radioactive source inventory data and subsequent changes to those data, except for routine movements of the source allowed in the licence—

2. unusual events or incidents, such as—

1. loss of control over a radioactive source;

2. unlicensed access to, or unlicensed use of, a source; or

3. discovery of any orphan sources;

3. any intentions to introduce modifications to any practice with a radioactive source whenever the modifications could have significant implications for safety; and

4. a copy of relevant parts of any contract or acceptance document relating to the return of radioactive sources intending to be imported.

3. The licensee shall report to the Authority any breach of these regulations within twenty four (24) hours, and shall include the information required by regulation 10.

4. For radioactive sources in category 1, 2 and 3, the licensee shall inform the Director of Public Prosecution and the Authority immediately of—

1. lost sources; and

2. actual or attempted theft of sources.

2. The guidance levels shall be established by relevant professional bodies or well known specialists, in consultation with the Authority, to provide an indication on what doses are achievable with current good practice for average sized patients.
    
3. the guidance levels shall be applied with flexibility to allow higher exposures if these are indicated by sound clinical judgements and shall be revised as required by technological and scientific developments and international standards.

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Part v

Management Requirements

27. Safety culture

A licensee shall establish a management system, commensurate with the size and nature of the licensed activity and practice, which ensures that—

1. policies and procedures are established that identify protection and safety as the highest priority;

1. estimate the probabilities and the magnitudes of potential exposures; and

2. assess the quality and extent of the protection and safety provisions.

33. Monitoring, testing and verification of compliance

—(1) A licensee shall conduct monitoring and measurements of the parameters necessary for verification of compliance with the requirements of these Regulations and a licence.

2. For the purposes of monitoring and verification of compliance, the licensee shall provide suitable equipment and introduce verification procedures.

3. The licensee shall ensure that equipment is properly maintained and tested and calibrated at appropriate intervals with reference to standards traceable to national or international standards.

34. inventory and records

—(1) A licensee shall maintain records of the results of monitoring and verification of compliance, including the inventory of radiation sources and radioactive waste, the transfer of radiation sources, radiation monitoring, testing of instruments and safety systems, calibrations and other checks carried out in accordance with requirements of these Regulations.

(2) Individual radioactive source records shall include the—

1. location of the source;
    
2. radionuclide;
    
3. radioactivity on a specified date;
    
4. serial number or unique identifier;
    
5. chemical and physical form;
    
6. source use history, including recording all movements into and out of the storage location;
    
7. receipt, transfer or disposal of the source; and
    
8. other information, as appropriate, to enable the source to be identifiable and traceable.

Part VII

Occupational Exposure Protection

35. General Responsibilities second Schedule

—(1) A licensee and an employer of workers who are engaged in activities that involve or could involve occupational exposure shall be responsible for the protection of the workers against any occupational exposure which is not excluded from these Regulations.

(2) The licensee and employer shall ensure, for all workers engaged in activities that involve or could involve occupational exposure, that—

1. occupational exposures are limited to the doses specified in the Second Schedule hereto;

2. radiation safety is optimized in accordance with regulations 23 and 24;

3. policies, procedures and organizational arrangements for occupational radiation 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;

1. suitable and adequate devices and equipment for radiation safety are provided, including personal protective devices and monitoring equipment, and training arrangements are made for their proper use;

2. radiation safety and health surveillance services are provided, as required, through qualified experts;

c. arrangements are made to facilitate consultation and cooperation with workers, through their representatives where appropriate, about measures which are needed to achieve adequate radiation safety by an effective implementation of these Regulations;

d. necessary conditions are provided and arrangements are made to promote a safety culture in the work force and achieve adequate training of workers on radiation safety matters;

e. occupational exposures are limited to within the doses specified in the Second Schedule hereto;

4. If workers are to be engaged in work that involves or could involve a radiation source which is not under the control of their employer, the licensee 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 such workers with adequate protective measures and safety provisions; 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.
   
   5. The licensee and employer 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.
   
   6. the licensee and employer 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 of radiation sources and in particular, the licensee and employers shall ensure that workers—

1. follow any applicable rules and procedures for protection and safety;

2. properly use the monitoring devices and the protective equipment and clothing provided;

3. abstain from any wilful action that could put themselves or others in situations that contravene the requirements of these Regulations; and

4. promptly report to the licensee and employer any circumstances that could adversely affect safety conditions or the requirements of these regulations.
   
   7. The licensee and employer shall record any report received from a worker that identifies any circumstances that could affect safety conditions or compliance with the requirements of these regulations, and shall take appropriate remedial actions.
   
   36. conditions of service

—(1) A licensee or an employer shall ensure that the conditions of service of workers are independent of the existence or the possibility of occupational exposure and shall not use special compensatory arrangements or preferential treatment with respect to salary or special insurance coverage, working hours, length of vacation, additional holidays or retirement benefits as substitutes for the provision of proper protection and safety measures to ensure compliance with the requirements of these regulations.

2. the licensee or employer shall advise female workers that they should notify the employer if pregnant and where a female worker has notified the employer that she is pregnant, the employer shall adapt the working conditions with respect to occupational exposure to ensure that the unborn baby is afforded the same broad level of protection which is required for members of the public:

Provided that notification of pregnancy shall not be considered a reason to exclude a female worker from work.

3. the licensee shall not subject a person under the age of sixteen (16) years to occupational exposure and the licensee shall not allow a person under the age of eighteen (18) years to work in a controlled area unless supervised and then only for the purpose of the training.

37. classification of areas

—(1) A licensee shall designate as a controlled area, any area in which specific protective measures or safety provisions are or could be required for—

1. controlling normal exposures or preventing the spread of contamination during normal working conditions; and
2. preventing or limiting the extent of potential exposures.

(2) the licensee 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 radiation source is brought into operation or energized only intermittently or is moved from place to place, delineate controlled area by means that are appropriate under the prevailing circumstances and specific exposure times;

1. adequate instruction and training on protection and safety, including information on general and local rules and procedures and on available protection and safety provisions; and

2. the significance for protection and safety of their actions;

1. make arrangements for an appropriate health surveillance programme in accordance with regulation 42;

2. provide to female workers who are liable to enter controlled areas or supervised areas appropriate information on—

1. the risk to the unborn baby due to exposure of a pregnant woman;

1. the importance for a female worker of notifying her employer as soon as she suspects that she is pregnant; and

2. the risk to an infant ingesting radioactive material 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.

39 Personal Protective equipment

A licensee and an employer shall—

1. minimize 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. if necessary, ensure that workers 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;

3. protective aprons and gloves and organ shields;

3. 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. 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.

40.Exposure assessment

—(1) A licensee and an employer shall arrange for the assessment of the occupational exposure of workers and ensure that adequate arrangements are made with appropriate dosimetry services under an adequate management system programme.

2. The licensee or employer shall ensure that individual monitoring is undertaken for any worker who is normally employed in a controlled area, where this is feasible and in cases where individual monitoring is not feasible, the occupational exposure of the workers shall be assessed on the basis of the results of monitoring of the workplace and of information on the locations and duration of exposure of the workers.
    
3. the licensee and employer shall ensure that for any worker who is normally employed in a supervised area or who enters a controlled area only occasionally, his occupational exposure is assessed, but the assessment may be on the basis of the results of monitoring of the workplace or of individual monitoring.
    
4. the nature, frequency and precision of individual monitoring shall be determined taking into consideration the magnitude and possible fluctuations of exposure levels and the likelihood and magnitude of potential exposures.
    
5. the licensee and employer 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 material or the committed doses, as appropriate.

 41.Monitoring of workplace

—(l) a licensee, in cooperation with an employer, where appropriate, shall establish, maintain and keep under review a programme for the monitoring of the workplace commensurate with the nature of and the risks associated with the radiation source.

2. the nature and frequency of monitoring of workplaces 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; and

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 actions to be taken if they are exceeded.

4. the licensee shall keep appropriate records of the findings of the workplace monitoring programme, which shall be made available to workers, where appropriate through their representatives.

42. Health surveillance

A licensee and an employer, in accordance with the rules established by the Authority, shall make arrangements for appropriate health surveillance based on the general principles of occupational health and designed to assess the initial and continuing fitness of workers for their intended tasks.

43. records of worker exposure

—(1) A licensee and an employer shall maintain records of exposure for each worker for whom assessment of occupational exposure is required under regulation 41 and such 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. The licensee and employer shall—

1. provide access by workers to information regarding their own exposure records and, where appropriate, to workplace monitoring records; and

2. upon request of the Authority or other persons or organizations 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 retained by the licensees and employers, or by the Authority in case the licensees and employers cease their activities.

4. these records shall be preserved at least until the worker attains or would have attained the age of seventy five (75) years, and for not less than thirty (30) years after the termination of the work involving occupational exposure.

44.Special circumstances

—(1) If a practice which is justified and for which radiation safety is optimized, presents special circumstances which require a temporary change in some dose limitation requirements of these Regulations, a licensee shall not make any such temporary change without the approval of the Authority.

2. An application submitted by the licensee to obtain the approval referred to in subregulation (1), shall include evidence to demonstrate that—

1. all reasonable efforts have been made to reduce exposures and optimize radiation safety provisions in accordance with the requirements of 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.

deemed to be unjustifiable unless it is expected to provide useful information on the health of the individual examined or unless the specific type of examination is justified by those requesting it in consultation with competent professional bodies.

2. Mass screening of population groups involving medical exposure is deemed to be unjustifiable 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.

3. The exposure of humans for medical research is deemed to be unjustifiable, unless it is—

1. in accordance with the provisions of the World medical Association Declaration of Helsinki, Ethical Principles for medical Research Involving Human Subjects and follows the guidelines for its application prepared by the council for international organizations of medical Sciences (cioMS) in collaboration with the World Health organization (WHo), international ethical Guidelines for Biomedical research involving Human Subjects; and

2. subject to the advice of the licensee’s ethical review committee and to any other applicable laws and regulations.

47 optimization of protection for medical exposures

In addition to satisfying the general requirements for optimization of radiation safety specified in these regulations, licensees, in cooperation with suppliers, where appropriate, shall satisfy the prescriptive design and operational requirements specified in Third Schedule hereto.

48 Calibration, clinical dosimetry and management system for medical exposures

—(1) A licensee shall ensure that—

1. the calibration of radiation sources used for medical exposure is traceable to a standards dosimetry laboratory in the country or abroad if accepted by the Authority;

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, and at regular intervals established or approved by the Authority.

2. The licensee shall ensure that important values of clinical dosimetry parameters are determined and documented.

3. Management system 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 management system programme for radiotherapy procedures.

49. Dose constraints

—(1) The optimization of protection of persons exposed for medical research purposes, if such medical exposure does not produce direct benefit to the exposed individuals, shall be subjected to individual dose constraints established on a case-by-case basis by the Authority or other institutional body assigned a similar function.

(2) A licensee 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 to patients who have received therapeutic amounts of radionuclides or who are being treated with brachytherapy sources, to a level not exceeding that specified in the third Schedule.

50. Guidance levels

A licensee shall ensure that guidance levels for medical exposure, determined as specified in regulation 26, are revised as technology improves and are used as guidance by medical practitioners, in order that—

1. corrective actions are taken as necessary if doses or activities fall substantially below the guidance levels, and the exposures do not provide useful diagnostic information and do not yield the expected medical benefit to; and
    
2. reviews are considered if doses or activities exceed the guidance levels, as an input to ensuring optimized protection of patients and maintaining appropriate levels of good practice.

51. Maximum activity for patients in therapy and discharge from hospital

—(1) in order to restrict the exposure of any members of the household of a patient who has undergone a therapeutic procedure with sealed or unsealed radionuclides and of members of the public, such a patient shall not be discharged from hospital before the activity of radioactive material in the body falls below the level specified by the Authority unless otherwise justified, and the justification is documented.

(2) A licencee shall provide written instructions to the patient concerning contact with other persons and relevant precautions for radiation protection where necessary.

52. Investigation of accidental medical exposure

—(1) A licensee shall promptly investigate any of the following situations—

1. any 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 values prescribed by the medical practitioner;

2. any diagnostic exposure substantially greater than intended or resulting in doses repeatedly and substantially exceeding the established guidance levels; and

3. any repeated equipment failure, accident, error, mishap or other unusual occurrence with the potential for causing a patient exposure significantly different from that intended.

2. The licensee shall, with respect to any investigation required above—

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 or incident;

3. implement all the corrective measures that are under his own responsibility;

4. notify the Authority by telephone or facsimile as soon as practicable, but in any case not later than twenty-four (24) hours after discovery, of any accident or incident which has the potential for, or has resulted in, serious injury or death of a patient, or which involves more than one patient;

5. submit to the Authority, within seven (7) days after discovery of the accident or incident, a written report which contains the cause of the incident and includes information on the doses, corrective measures and any other relevant information; and

6. inform the patient and his doctor about the accident or incident.

53. Records related to medical exposures

A licensee shall keep and make available, as appropriate, records of equipment calibration, clinical dosimetry and management system, as well as any other necessary information to allow retrospective assessments of the exposures doses received by patients.

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Part IX

Public Exposure Protection

54. —General responsibilities

(1) A licensee shall apply the requirements of these Regulations to General any public exposure delivered by a practice or source for which they responsible, unless the exposure is excluded from the application of these Regulations or the practice or source delivering the exposure is exempt from the requirements of these Regulations.

(2) The licensee shall be responsible, with respect to the sources under his responsibility, for the establishment, implementation and maintenance of—

1. radiation safety policies, procedures and organizational arrangements for control of public exposure;

2. measures for ensuring—

1. the optimization 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 the Second Schedule;

3. measures for ensuring the safety 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 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. informing the public, and particularly critical groups, about radiation safety measures to be taken in case of an accident or incident such as lost radioactive sources; and

8. adequate records of the surveillance and monitoring.

55. Control of visitors

A licensee shall—

1. ensure that visitors to any controlled area are accompanied by a person knowledgeable about the radiation safety measures for that area;
    
2. provide adequate information, instruction and protective means, as necessary, to visitors before they enter a controlled area to ensure appropriate protection of the visitors and workers who may 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.

56. Sources of External irradiation

A licensee 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 utilizing such sources of external irradiation are subject to review and approval by the Authority;
    
2. specific dose constraints for the operation of such a source are established to the satisfaction of the Authority; and,
    
3. shielding and other protective measures that are optimized, in accordance with the requirements of these regulations, are provided as appropriate for restricting public exposure to the satisfaction of the Authority.

57. Radioactive contamination in enclosed spaces

A licensee shall ensure that—

1. for sources for which they are responsible, measures that are optimized 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 minimize spread of radioactive contamination in areas accessible to the public.

58. Monitoring of Public exposure

A licensee shall, as appropriate—

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

59. Consumer products

—(1) A person shall not supply consumer products capable of causing exposure to radiation to members of the public unless—

1. such exposure is excluded from these regulations under regulation 7;

2. such products meet the exemption requirements specified in regulation 16 or have otherwise been exempted by the Authority; or

3. such products are licensed by the Authority for use by members of the public.

2. A person who imports consumer products, as exempt products, for subsequent sale and distribution shall include in the application to the Authority for a licence to distribute, a copy of the exporter’s or other legal persons’ licence issued by the Authority in the country of manufacture or origin which authorizes distribution to members of the public in that country.

3. A person who imports consumer products for sale and distribution, as exempt products shall ensure that—

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

(i). the product contains radioactive material; and

2. the sale of the product to the public has been licensed by the relevant Authority; and

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

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A licensee, in specific cooperation with a supplier where appropriate, shall—

1. ensure, on procurement of new equipment containing radiation generators or sources, that such equipment and sources conform to applicable standards of the International Electrotechnical commission (IEc) and the International Standards organization (ISo) except for IEc and ISo standards, other standards applied in the country of origin of such equipment and sources shall have the acceptance of the competent authority in this matter;

2. ensure that sources and equipment are tested to demonstrate compliance with the appropriate specifications;

3. conduct a safety assessment, either generic or specific, for the sources for which they are responsible, according to the requirements of regulation 32;

4. ensure that performance specifications and operating and maintenance instructions, including protection and safety instructions, are provided in English and local languages and in compliance with the relevant IEc and ISo standards with regard to accompanying documents, and that this information is translated into the local language when appropriate; and

5. ensure that, where practicable, the operating terminology and operating values are displayed on operating consoles or other control systems in an appropriate language as specified in paragraph above.

62. Supply and procurement of radioactive sources

—(1) A licensee who supplies and distributes radioactive sources shall ensure that the persons to whom the sources are being supplied are licensed to receive the sources.

(2) The licensee shall, before purchasing or otherwise acquiring a radioactive source—

(a) make arrangements with respect to the safe management of the source, including financial provisions, where appropriate, once the source becomes disused; and

2. submit to the Authority details of the arrangements, including copies of any contractual arrangements.
   
   3. The licensee supplying radioactive sources or devices incorporating radioactive sources shall provide the recipient with all relevant technical information to permit their safe management.
   
   63. Domestic transfer of radiation sources
   
   1. A licencee shall not transfer radiation sources to another party unless—

1. he is licensed to do so by the Authority;

2. the recipient possesses a valid licence for the sources; and

3. the recipient is provided with all relevant technical information to permit the safe management of the sources.

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Part XI

Import and Export of Category 1 or 2 Radioactive Sources

64. Export category 1 or 2 radioactive sources

—(1) A licensee who intends to export Category 1 or 2 radioactive source shall apply to the Authority for an export licence and shall pay the fees prescribed in the fifth schedule.

2. The application for licence to export a source shall include a copy of the recipient licence to receive and possess the source to be exported that includes at least the following information—

1. name of the recipient;

2. recipient location and legal address or principal place of business;

3. relevant radionuclides and radioactivity;

4. uses of the source, if appropriate; and

5. recipient licence expiration date, if any.

3. other information to be submitted as part of the application for licence to export, may include, as applicable—

1. copies of relevant parts of any contractual agreements to re-import the source; and

2. justification or explanation of any need to use the “exceptional circumstances” provisions.

4. After receiving a licence to export the source, the licensee shall ensure that—

1. the export of the source is conducted in compliance with all applicable transport requirements of the international Atomic Energy Agency Regulations for the Safe Transport of Radioactive Material;

2. the competent authority of the importing country is notified in advance, at least seven (7) days to the extent practicable, of each shipment with the following information in writing—

1. the estimated date of export;

2. exporting facility;

3. recipient;

4. radionuclide(s) and radioactivity;

5. aggregate activity level; and

6. the number of radioactive sources and, if available, their unique identifiers; and

3. for category 1 sources only, the notification described above shall be accompanied by a copy of the consent from the competent authority of the importing country to import the sources.
   
   65. Import of category 1 and 2 radioactive sources

—(1) A licensee who intends to import category 1 or 2 radioactive sources shall apply to the Authority for an import licence.

2. The application for the licence to import a source shall include the following information—

1. name of the exporter,

2. exporter location and legal address or principal place of business,

3. name of the recipient;

4. recipient location and legal address or principal place of business;

5. relevant radionuclides and radioactivity;

6. uses of the source, if appropriate;

7. details of the arrangements for the safe management of the source, including financial provisions where appropriate, once they have become disused, including copies of any contractual agreements; and

8. justification or explanation of any need to use the “exceptional circumstances”provisions, if applicable.

3. After receiving the licence to import the source, the licensee shall ensure that the import of the source is in compliance with all applicable transport requirements of the international Atomic Energy Agency regulations for the Safe transport of radioactive Material.

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Part XII

Radioactive Waste Management Requirements

66. Radioactive  waste classification

A licensee shall classify radioactive waste in accordance with specific requirements provided by the Authority in accordance with the international Atomic Energy Agency Safety Series No.lll-G 1.1- Classification of Radioactive Waste Safety Guide.

67. General responsibilities

A licensee shall be responsible for the safe management of the radioactive waste generated by the practices or sources for which he is licensed and shall take all necessary measures to ensure that—

1. generation of the activity and volume of radioactive waste are kept to the minimum practicable by suitable design, operation and decommissioning of its facilities;

1. A licensee shall ensure that appropriate measures are taken to keep generation of radioactive waste and its environmental impact and cost to the minimum practicable by—

1. avoiding the use of unnecessarily hazardous or toxic materials;

2. minimizing the activity of waste by using the minimum quantity of radioactive material needed;

3. using short lived radionuclides, where practicable and an appropriate selection of materials for the construction of facilities;

4. incorporating into the design of facilities features to facilitate future decommissioning;

5. minimizing the amount of waste by preventing unnecessary contamination of materials;

6. applying careful planning to the design, construction, administration, operation and decommissioning of facilities so that the generation of radioactive waste is kept to the minimum practicable; and

7. maintaining consistency with the management strategy and systems.
   
   71. Collection Segregation and characterization of radioactive waste

—(1) A licensee shall ensure that waste is collected, segregated, and characterized, at the point of origin in accordance with the classification system established by the Authority and the following criteria—

1. non-radioactive and radioactive;
    
2. short-lived, for instance half-lives less than one hundred (100) days, suitable for decay storage;
    
3. activity and radionuclide content;
    
4. physical and chemical form—
   
   
   i). liquid—

1. aqueous; and
2. organic;

2. non-homogeneous, for instance containing sludges or suspended solids;

3. solid—

1. combustible or non-combustible, if applicable; and

2. compactable or non-compactable, if applicable;

5. spent sealed sources;

6. non-radiological hazardous waste, for instance toxic, pathogenic, infectious, genotoxic or biological; and

7. mixed waste, that is radioactive and hazardous waste.

2. After segregation, each waste stream shall be kept in separate containers.

Part XIV

Transportation of Radioactive Sources or Waste

85. Transport requirements

A licensee transporting radioactive sources or radioactive waste, either domestically or internationally, shall do so in compliance with all applicable transport requirements of the International Atomic Energy Agency Regulations for the Safe Transport of Radioactive Material.

Part XV

Requirements for Emergency Intervention

86. Responsibilities of a licensee

—(1) If a licensed practice or source, including radioactive waste within a practice, has a potential for accidents that may provoke unplanned exposure of any person, a licensee shall ensure that an emergency plan appropriate for the source and its associated risks is prepared and is kept operational.

2. The effectiveness of the emergency plan referred to in sub-regulation (1) shall be verified to the satisfaction of the Authority by means of systematic drills.
    
3. If a licensed source is involved in an accident or incident, the licensee shall be responsible for taking such protective actions as may be required for the protection of occupationally exposed workers undertaking intervention and for the protection of the public from exposure as set forth in the licence application and emergency plans approved by the Authority, or as might otherwise by required by the Authority to protect against, mitigate or remediate a hazardous situation involving the licensed sources.

87. Licensee Emergency response planning requirements

1. A licensee responsible for a source, including radioactive waste for which prompt intervention may be required, shall ensure that the emergency plan defines on-site responsibilities and takes account of off-site responsibilities of other intervening organizations appropriate for implementation of the emergency plan and the emergency, and the plans shall, as appropriate—

1. characterize the content, features and extent of a potential emergency, taking into account the results of any accident analysis and any lessons learned from operating experience and from accidents that have occurred with sources of a similar type—

1. identify the various operating and other conditions of the source which could lead to the need for intervention;

2. describe the methods and instruments for assessing the accident and its consequences on and off the site;

3.  provide for protection and mitigation actions, and assignment of responsibilities for initiating and discharging such actions;

4. provide for rapid and continuous assessment of the accident as it proceeds and determining the need for protective actions;

5.  allocate responsibilities for notifying the relevant authorities and for initiating intervention;

6. provide procedures, including communication arrangements for contacting any relevant intervening organization, for instance civil or defence and for obtaining assistance from firefighting, medical, police and other relevant organizations;

7. provide for training personnel involved in implementing emergency plans and be rehearsed at suitable intervals based on requirements defined in regulation 29 (2) in conjunction with designated authorities; and

8. provide for periodic review and updating of the plan.

88. Implementation of intervention

—(1) A licensee shall ensure that the protective actions or remedial actions aimed at reducing or averting accidental exposures are only undertaken when they are justified, taking into account health, social and economic factors.

2. The form, scale and duration of any justified intervention shall be optimized so as to produce the maximum net benefit under the prevailing social and economic circumstances.

3. the licensee shall promptly notify the Authority when an accidental situation requiring intervention has arisen or is expected to arise and shall keep the Authority informed of:

1. the current situation and its expected evolution;

2. the measures taken to terminate the accident and to protect workers and members of the public; and

3. the exposures that have been incurred and that are expected to be incurred.

89. Protection of workers undertaking an intervention

—(1) A worker undertaking an intervention shall not be exposed in excess of the maximum single year dose limit for occupational exposure specified in the Second Schedule hereto except—

1. for the purpose of saving life or preventing serious injury;

2. if undertaking actions intended to avert a large collective dose; or

3. if undertaking actions to prevent the development of catastrophic conditions.

2. While undertaking intervention under these circumstances, the licensee shall take reasonable efforts to keep doses to workers below twice the maximum single year dose limit, except for life saving actions, in which case every effort shall be made to keep doses below ten times the maximum single year dose limit in order to avoid deterministic effects on health.

3. in addition, the licensee shall ensure that workers undertaking actions in which their doses may approach or exceed ten times the maximum single year dose limit do so only when the benefits to others clearly outweigh their own risk.

—(1) An applicant for a licence may propose to apply recommendations regarding facilities and equipment, procedures, qualifications and training of personnel, maintenance and management system contained in safety and good practice publications issued by the International Atomic Energy Agency, World Health Organization, Pan American Health organization or other international bodies as methods by which performance requirements in these Regulations shall be met and in such cases, the applicant shall—

1. identify the document; and

2. identify both the particular recommendation or part of the document being adopted and the performance requirement in these Regulations it is intended to implement.

2. The Authority shall determine whether the proposal referred to in sub-regulation (1) is acceptable.

3. The applicant for a licence may adopt, by reference any of the documents listed under References, to the extent that they are relevant to the particular practice and the applicant may propose to use other relevant documents that are not listed under References provided that the documents are clearly identified and copies of the relevant parts of the documents are included with the application.

FIRST SCHEDULE

Form for Notification of Practices and Sources      (reg. 15)

Atomic     Energy     Regulations Authority

(Use one form for each source to be notified)

1. Name and address of the legal person:..............................................................................................
   
   ..........................................................................................................

2. Name and address of the organization: .........................................................................................................
   
   ..........................................................................................................

3. Nature of the practice in which the source is used: ...................................................................
   
   ..........................................................................................................

4. Identification of each source: ..............................................................................................................
   
   ..............................................................................................................

Radionuclide

Activity (Bq):.......................................................................................................

Chemical form:....................................................................................................

Sealed source:......................YES/No If Yes = Manufacturer: .................................

Model:................................................................................................................

Radiation Generating Equipment

Manufacturer:......................................................................................................

Model:.................................................................................................................

operating potential:................................................................................................

Nature of the equipment in which the source is installed: ..........................................       

Model (if appropriate): ............................................................................................

Date:......................................

.......................................

Signature for Legal Person


 

SECOND SCHEDULE

Dose Limits for Exposures Incurred from Practices

Occupational Dose Limits                    (reg. 23)

The occupational exposure of any worker shall be so controlled that the following limits are not exceeded:

1. an effective dose of 20 mSv per year averaged over five consecutive years;

2. an effective dose of 50 mSv in any single year;

3. an equivalent dose to the lens of the eye of 150 mSv in a year; and

4. an equivalent dose to the extremities (hands and feet) or the skin of 500 mSv in a year.

For apprentices of 16 to 18 years of age who are training for employment involving exposure to radiation and for students of age 16 to 18 years who are required to use sources in the course of their studies, the occupational exposure shall be so controlled that the following limits be not exceeded:

1. an effective dose of 6 mSv in a year;
    
2.  an equivalent dose to the lens of the eye of 50 mSv in a year; and
    
3. an equivalent dose to the extremities or the skin of 150 mSv in a year.

Special Circumstances

When, in special circumstances, a temporary change in the dose limitation requirements is approved:

1. the dose averaging period mentioned in paragraph (a) above may exceptionally be up to 10 consecutive years as specified by the regulatory body, and the effective dose for any worker shall not exceed 20 mSv per year averaged over this period and shall not exceed 50 mSv in any single year, and the circumstances shall be reviewed when the dose accumulated by any worker since the start of the extended averaging period reaches 100 mSv; or

2. the temporary change in dose limitation shall be as specified by the regulatory body, but shall not exceed 50 mSv in any year and the period of the temporary change shall not exceed 5 years.

Dose Limits for the Public

The estimated average doses to the relevant critical groups of members of the public that are attributable to practices shall not exceed the following limits:

1. an effective dose of 1 mSv in a year;
    
2. in special circumstances, an effective dose of up to 5 mSv in a single year provided that the average dose over five consecutive years does not exceed 1 mSv per year;
    
3. an equivalent dose to the lens of the eye of 15 mSv in a year; and
    
4.  an equivalent dose to the skin of 50 mSv in a year.

Internal Exposure

Internal exposure caused by inhalation or ingestion of radioactive material shall be estimated in accordance with the methodologies, parameters and values contained in the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources, International Atomic Energy Agency Safety Series No. 115 [3], Schedule II.

Dose Limitations for Comforters and Visitors of Patients

The dose limits set out in this Part shall not apply to comforters or visitors of patients. However the dose of any such comforter or visitor shall be constrainedso that it is unlikely that the dose will exceed 5 mSv during the period of the diagnostic examination or treatment. The dose to children visiting patients whohave ingested or have been injected with radioactive material shall be similarly constrained to less than 1 mSv.

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THIRD SCHEDULE

Medical Exposure Design and Operational

REQUIREMENTS (reg. 45)

Design of sources and equipment

1. The requirements related to the design and procurement of sources and the accountability and security of sources of these Regulations shall apply to sourcesused in medical exposure where relevant and, in particular, equipment used in medical exposure shall be so designed that:

1. failure of equipment or components can be promptly detected so that any unplanned exposure of patients can be avoided or minimized; and

2. the risk of delivering unplanned exposure to patients by human error is minimized.

2. Licensees, in co-operation with suppliers where relevant or appropriate, shall:

1. ensure that radiation generators, sources and accessories are designed and manufactured so as to facilitate the keeping of medical exposures as low as reasonably achievable consistent with obtaining adequate diagnostic information or therapeutic results;

2. ensure that equipment containing sources for medical exposure is conform to applicable international (e.g. IEC, ISO) and national standards;

3. ensure that performance specifications and operating and maintenance instructions, including radiation safety aspects, are provided in a major world language understandable to the users as well as in the local language;

4. identify and take all reasonable measures to prevent failures and human errors that could result in unplanned medical exposures, including the establishment of adequate procedures for calibration, management system and operation of diagnostic and therapeutic equipment as well as the selection, training and periodic retraining of suitably qualified personnel;

5. ensure that any radiation emitting equipment is provided with radiation beam control mechanisms, including safety interlocks and clear and fail-safe ‘on-off’ indicators;

6. ensure that devices are provided to limit the exposure to the area being examined or treated and keep exposure rates outside this area, due to radiation leakage or scattering, as low as reasonably achievable;

7. ensure that, when appropriate, monitoring equipment is installed or is available to give warning of an unusual situation or trend in the use of radiation emitting equipment for diagnostic or therapeutic applications.

Operational aspects

(1) Diagnostic exposure

A licensee shall make sure that—

(a).  the medical practitioners who prescribe or conduct radiological diagnostic examinations:

1. ensure that the appropriate equipment is used;

2. ensure that the exposure of patients is the minimum necessary to achieve the required diagnostic objective, taking into account norms of acceptable image quality established by appropriate professional bodies and relevant guidance levels for medical exposure;

3. take into account relevant information from previous examinations in order to avoid unnecessary additional examinations;

4. avoid radiological examinations causing exposure of the abdomen or pelvis of women who are pregnant or likely to be pregnant unless there are strong clinical reasons for such examinations;

5. plan any diagnostic examination of the abdomen or pelvis of women of reproductive capacity, between the ages of 12 50 years, so as to deliver the minimum dose to any embryo or foetus that might be present;

6. ensure that portable and mobile radiological equipment is used only for examinations where it is impractical or not medically acceptable to transfer patients to a stationary radiological installation and only after proper attention has been given to the radiation protection measures required in its use; and

7. ensure that, whenever feasible, shielding of radiosensitive organs such as the gonads, lens of the eye, breast and thyroid is provided as appropriate;
   
   (b) the medical practitioner, the technologist or other imaging staff select the following parameters, as relevant, such that their combination produce the minimum patient exposure consistent with acceptable image quality and the clinical purpose of the examination, paying particular attention to this selection for paediatric radiology and interventional radiology:
   
   i. the area to be examined, the number and size of views per examination (e.g.number of films or computed tomography slices) or the time per examination (e.g. fluoroscopic time);
   
   ii. he type of image receptor (e.g. high versus low speed screens);
   
   iii. the use of antiscatter grids;
   
   iv. proper collimation of the primary x ray beam to minimize the volume of patient tissue being irradiated and to improve image quality;
   
   v. appropriate values of operational parameters (e.g. tube generating potential, current and time or their product);
   
   vi. appropriate image storage techniques in dynamic imaging (e.g. number of images per second); and
   
   viii. adequate image processing factors (e.g. developer temperature and image reconstruction algorithms).
   
   (2) Nuclear Medicine
   
   Alicensee shall make sure that:
   
   (a) medical practitioners who prescribe or conduct diagnostic applications of radionuclides:

3. 1. ensure that the exposure of patients is the minimum required to achieve the intended diagnostic objective taking into account relevant guidance levels for medical exposure;
       
   2. take into account relevant information from previous examinations in order to avoid unnecessary additional examinations;
       
   3. avoid administration of radionuclides for diagnostic procedures to women pregnant or likely to be pregnant unless there are strong clinical indications;
       
   4. for mothers in lactation, recommend discontinuation of nursing until the radiopharmaceutical is no longer secreted in an amount estimated to give an unacceptable effective dose to the nursling; and
       
   5. ensure that administration of radionuclides to children for diagnostic procedures is carried out only if there is a strong clinical indication, and the activity of the radionuclides administered is reduced according to body weight, body surface area or other appropriate criteria.
   
   b. the medical practitioner, the technologist or other imaging staff, as appropriate, endeavour to achieve the minimum patient exposure consistent with acceptable image quality by:
   
   i. appropriate selection of the best available radiopharmaceutical and its activity, noting the special requirements for children and for patients with impairment of organ function;
   
   ii. use of methods for blocking the uptake in organs not under study and for accelerated excretion when applicable; and,
   
   iii. appropriate image acquisition and processing.
   
   3. Therapeutic exposure
   

   A licencee shall make sure that the medical practitioners who prescribe or conduct radiotherapy procedures with radiation sources or with radionuclides:

   1. ensure that the prescribed absorbed dose is delivered to the planning target volume or organ;
       
   2. ensure that exposure of normal tissue during radiotherapy is kept as low as reasonably achievable consistent with delivering the required dose to the planning target volume, and organ shielding is used when feasible and appropriate;
       
   3. avoid radiotherapeutic procedures causing exposure of the abdomen or pelvis of women who are pregnant or likely to be pregnant unless there are strong clinical indications;
       
   4. avoid administration of radionuclides for therapeutic procedures to women who are pregnant or likely to be pregnant or who are nursing, unless there are strong clinical indications;
       
   5. plan any therapeutic procedure for pregnant women so as to deliver the minimum dose to any embryo or foetus;
       
   6. and,inform the patient of possible risks.
       

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                FOURTH SCHEDULE

   categorization of Radioactive Sources     (reg. 2)

   The International Atomic Energy Agency Categorization of Radioactive Sources provides an internationally harmonized basis for risk informed decision making, and can be used by national authorities in establishing the appropriate degree of regulatory control for many activities relating to the safety and security of radioactive sources. The categorization system is based on the concept of ‘dangerous sources’ - which are quantified in terms of ‘D-values’. The D-value is the radionuclide-specific activity of a source which, if not under control, could cause severe deterministic effects for a range of scenarios that include both external exposure from an unshielded source and inadvertent internal exposure following dispersal (e.g.: by fire or explosion) of the source material. A full list of radionuclide-specific D-values is given in IAEA-EPR-D-Values 2006 |301 and the D-values for the radionuclides from Annex I of the Code of Conduct are given in Table IV-1 below—

   Table IV-1. Activities corresponding to thresholds of categories (From Annex I of Code)

   
   

   Category 1                Category 2	Category 3
   Radionuclide            1000 x D	10 x D	D

The category of a source can be determined by dividing the activity of the source (‘A’ in TBq) by the D-value for the relevant radionuclide, and comparing the A/D value with those given in column 2 of table IV-2.

In some situations it may be appropriate to categorize a source on the basis of A/D alone for example, when the practice for which the source may be used is unknown or not confirmed, as may happen at the time of import or export of the source. However, when the circumstances of use of the source
are known, the regulatory body may make a judgement to modify this initial categorization using other information about the source or its use. In some circumstances it may, therefore, be convenient to assign a category on the basis of the practice in which the source is used, as shown in column 3 in table IV-2).

Note: The categorization system set is composed of five categories, as shown in Table Iv-2 below. This number of categories is considered sufficient to enable the practical application of the scheme, without unwarranted precision. Within this categorization system, sources in Category 1 are considered to be the most ‘dangerous’ because they can pose a very high risk to human health if not managed safely and securely. An exposure of only a few minutes to an unshielded Category 1 source may be fatal. At the lower end of the categorization system, sources in Category 5 are the least dangerous;

however, even these sources could give rise to doses in excess of the dose limits if not properly controlled, and therefore need to be kept under appropriate regulatory control. Categories should not be subdivided as this would imply a degree of precision that is not warranted and would lead to a loss of international
harmonization.

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D

Where:

Ai,n =           activity of each individual source i of radionuclide n.

Dn = D value for radionuclide n.

FIFTH SCHEDULE

fees (regs 14, 17, 64,)

For more than 6 radiation sources category 1 category 2 Category 3 category 4 Category 5 4.

License to mine and/or process radioactive minerals 1 year 3,000,000 2 years           5,500,000

⁵. Licence to transport radioactive material or radioactive minerals

(Per consignment)                                                400,000

6Licence to import category 1 and category 2 radioactive source

(per import for one source)                                  400,000

⁷. Licence to export category 1 and category 2 radioactive source

(per import for one source)                                  400,000

9 Licence to generate, keep or manage radioactive waste ' ^(annual)2,000,000

9. Licence to operate Radioactive waste storage facility ^ qqq qqq (Annual)