IONISATION RADIATION ACT: SUBSIDIARY LEGISLATION
INDEX TO SUBSIDIARY LEGISLATION
Ionizing Radiation (Fees) Regulations
Ionizing Radiation Protection Regulations
Ionising Radiation Protection (Commencement), Order
Ionising Radiation Protection (General) Regulations
IONIZING RADIATION (FEES) REGULATIONS
[Section 26]
[Currency mentioned in this regulation should be re-denominated as stipulated under S 4 of Re-denomination Act, 2012, read with S 29 of Bank of Zambia Act, 1996.]
{mprestriction ids="2,3,5"}
Arrangement of Paragraphs
Paragraph
[Regulations by the Minister]
SI 86 of 1992,
SI 46 of 1996.
These Regulations may be cited as the Ionizing Radiation (Fees) Regulations.
There shall be paid as set out in the Schedule, the fees and charges for the use of the services of the National Radiation Protection Service by members of the public and institutions.
[Am by Act 13 of 1994.]
[Regulation 2]
[Sch subs by reg 2 of SI 46 of 1996.]
|
Fee Units |
||
|
1. |
Personal dosimetry Service |
|
|
2. |
(a) Individual per year |
56 |
|
3. |
(b) Replacement of lost badge |
56 |
|
4. |
(a) Quality Assurance in Diagnostic Radiology |
556 |
|
5. |
(b) Extra X-ray Machine |
278 |
|
6. |
Inspection of Ionizing Radiation Facility Quality Control |
556 |
|
Consultation |
278 |
|
|
(a) Institutional Licence Fees |
556 |
|
|
(b) Amendment of Licence |
278 |
|
|
Calibration of monitoring Equipment per item |
556 |
IONIZING RADIATION PROTECTION REGULATIONS
[Section 26]
[RETAINED AS PER S.15 OF INTERPRETATION AND GENERAL PROVISIONS ACT]
Arrangement of Regulations
PART I
PRELIMINARY
Regulation
PART II
LIMITS OF EXPOSURE TO RADIATION
4. Dose equivalent limits for workers
5. Dose limits of women of reproductive capacity
9. Dose equivalent limits for individual members of the public
10. Dose equivalent limits for students
11. Dose equivalent limits for teachers, instructors, etc.
12. Dose equivalent limits for medical personnel
PART III
STRUCTURAL REQUIREMENTS AND INSPECTIONS OF BUILDINGS:
13. Use of building for radiation purposes
15. Warning signs for restricted and controlled areas
PART IV
LICENSING
18. Permissible levels of radionuclides
PART V
TRANSPORT AND STORAGE OF RADIOACTIVE MATERIALS
19. IAEA Transport Regulations
23. Acknowledgement receipt of dispatch of radioactive material
24. Investigation of shipment of radioactive material
PART VI
RADIATION SAFETY OFFICER
26. Duties of radiation safety officer
PART VII
RADIOATIVE RELEASES TO THE ENVIRONMENT
PART VIII
EXPOSURE FROM CONSUMER PRODUCTS
PART IX
CESSATION AND SUSPENSION OF OPERATION, DECOMMISSIONING AND ABANDONMENT OF INSTALLATION
[Regulations by the Minister]
SI 171 of 1992
PART I
PRELIMINARY
These Regulations may be cited as the Ionizing Radiation Protection Regulations.
(1) In these Regulations, unless the context otherwise requires:
"absorbed dose" means the amount of energy deposited by ionizing radiation per mass of the material;
"Board" means the Radiation Protection Board;
"dose equivalent" means product E of absorbed dose and the weighting factors;
"non-stochastic" means manifestation whose severity of effect varies with dose and for which a threshold dose does occur but below which the effects are not detectable at all;
"personal monitoring" means measurement of a dose with a film with a device such as a film badge, pocket ionizing chamber, or thermoluminescent dosimeters worn by an individual;
"radionuclide" means a radioactive substance characterized by its atomic nucleus;
"reproductive capacity" means the period in a woman commencing with the onset of menarche and ending with menopause;
"stochastic effects" means-
(a) the manifestation whose probability of occurrence in a population exposed to ionizing radiation rather than severity in an affected individual, may be a direct function of dose;
(b) the heredity effect and some somatic effects such as carcinogenesis and the severity of stochastic effects if it occurs, shall be independent of the dose responsible for its induction;
"Sievert" means an international standard unit of measurement equal to the absorbed dose multiplied by a weighting factor, a distribution factor or any other modifying factor;
"threshold dose" means the minimum absorbed dose that will produce a detectable degree of any given effect;
"warning signs" means any of the radiation signs given in the Fifth Schedule; and
"workers" mean all persons potentially exposed to dangerous ionizing radiation or radioactive material as a result of their occupation.
(2) The dose equivalent limits specified in these Regulations:
(a) are based on the exposure received over a period of one year, without regard to the rate of dose accumulation, except in the case of production capacity in which the time distribution of the dose equivalent shall be taken into account;
(b) shall not include contribution from natural background radiation or from medical exposure of patients to ionizing radiation; and
(c) shall include the consideration of the stochastic and non-stochastic effects.
(3) The annual dose equivalent limits shall comprise the sum of the annual dose equivalent arising from external exposure due to external sources, ionizing radiation or internal exposure due to intake of radionuclides.
For the purpose of these Regulations, the competent authority shall be the Radiation Protection Board.
PART II
LIMITS OF EXPOSURE TO RADIATION
4. Dose equivalent limits for workers
(1) The annual dose equivalent limits for workers shall be 0.5 Sv per year in any tissue except the lens of the eye whose limit shall be 0.15 Sv per year.
(2) The dose equivalent limits for workers in uniform exposed to ionizing radiation shall be 50 Sv per year.
(3) The effective dose equivalent for different tissues shall be computed by summing up the product on individual tissue doses and multiplying it with weighting factors set out in the First Schedule.
(4) The feet, ankles, skin and lens of the eye shall not be included in the computation of effective dose equivalent but shall be included in the relevant dose equivalent limits given in sub-regulation (1).
(5) The equivalent stochastic risk shall be estimated from the effective dose of the tissues of the body irradiated non-uniformly.
(6) The weighting factors for computation of the effective dose equivalent shall be as specified in the First Schedule.
5. Dose limits of women of reproductive capacity
(1) No person shall expose a woman of reproductive capacity to ionizing radiation without considering the pregnancy and the possibility of early unrecognised pregnancy.
(2) No person shall for a woman of reproductive capacity cause the embryo to receive more than 5 mSv of radiation during the first two months of pregnancy.
(3) No person shall expose a foetus in a pregnant woman to a dose exceeding 10 mSv.
(1) The contribution of internal exposure, without external exposure, to dose equivalent of annual limits of intake to radionuclides by workers shall not exceed the annual dose limit fixed in sub-regulation (2) and (3) of Regulation 3.
(2) The value of the annual limits of the intake for a single radionuclide and corresponding derived air concentrations shall be as set out in the Third Schedule.
(3) The sum of the weighted contribution of the various radionuclides to dose equivalent shall not exceed the limits set out in sub-regulation (2) and (3) of Regulation 4 where the intake exceeds one radionuclide during a working year.
(4) The provisions of sub-regulation (2) of Regulation 3 shall be observed where a worker is externally exposed to radionuclides.
(1) The planned special exposure for workers recommended by the International Commission on Radiological Protection shall apply to these regulations.
(2) Workers involved in planned special exposure shall be informed by the owner of the involved radiation facility about the nature of the risks and must consent to such exposure before under-taking the special operations.
(3) The dose equivalent received by planned special workers exposed under sub-regulation (2) of Regulation 3, shall be estimated and expert medical advice sought.
(1) The dose equivalent shall be assessed through personnel monitoring.
(2) The personnel monitoring under sub-regulation (1) shall be carried out at least once every two months.
9. Dose equivalent limits for individual members of the public
(1) The dose equivalent limits for members of the public shall be one-tenth of that permitted for workers under Regulation 3.
(2) The dose equivalent limits for members of the public shall be taken into account when planning radiation facility.
10. Dose equivalent limits for students
The authorized dose equivalent limits for students in educational institutions shall be as set out in the Second Schedule.
11. Dose equivalent limits for teachers, instructors, etc.
The dose equivalent limit for teaching staff, instructors, technicians and laboratory assistants at all educational institutions shall be the same as the workers.
12. Dose equivalent limits for medical personnel
(1) Any medical personnel shall in relation to a patient in their care ensure that:
(a) unnecessary exposure is avoided;
(b) exposure is justifiable in terms of benefits that would not otherwise be available; and
(c) the dose actually administered is limited to the minimum benefit of the patient.
PART III
STRUCTURAL REQUIREMENTS AND INSPECTIONS OF BUILDINGS:
13. Use of building for radiation purposes
No person shall use a building to install or use irradiating devices or use or store any radioactive materials without a certificate of compliance issued under these regulations.
Any area where radioactive materials or irradiating devices are used or installed shall be clearly marked and classified as-
(a) Restricted Radiation Area-where procedures with radiation devices or radioactive materials are restricted to the average dose equivalent rates exceeding 0.25 mSV/hr;
(b) Controlled Radiation Area-where procedures with radiation devices or radioactive materials are restricted to dose equivalent rates of 2.5 mSv/hr or less; or
(c) Uncontrolled Radiation Area-place within confines of a radiation facility where the external radiation or radioactive communication are not detectable.
15. Warning signs for restricted and controlled areas
(1) The boundaries walls and doors of restricted and controlled areas referred to in Regulation 13 shall have warning signs.
(2) Access to restricted areas shall be under strict control of the Radiation Safety Officer.
PART IV
LICENSING
(1) Any person who intends to use radioactive materials or devices shall apply to the Board for a licence.
(2) An application for a licence shall be in the form prescribed in the Fifth Schedule.
The types of licences to be issued under these regulations are set out in the Fourth Schedule.
18. Permissible levels of radionuclides
The maximum permissible levels of radionuclides shall be as set out in the Third Schedule.
PART V
TRANSPORT AND STORAGE OF RADIOACTIVE MATERIALS
19. IAEA Transport Regulations
A person delivering radioactive materials to a transport carrier, or any person transporting radioactive materials within, through or into the country shall comply with the International Atomic Energy Agency's "Regulations for the Transport of Radioactive Materials; Safety Series No. 6, 1985, (hereinafter referred to as "IAEA Transport Regulations")."
The package and design for the transportation of radioactive materials, through or into the country shall be in accordance with the requirements of the IAEA Transport Regulations.
Any radioactive materials stored in transit shall be stored in accordance with the IAEA Transport Regulations and handled in transit in accordance with instructions issued by the Board.
Any transfer of radioactive materials shall, prior to the transfer, be reported to the Board in the prescribed form.
23. Acknowledgement receipt of dispatch of radioactive material
The person who sends the radioactive material shall ensure that an acknowledgement receipt of the dispatched radioactive material is received within thirty days.
24. Investigation of shipment of radioactive material
(1) The person who sends the radioactive material shall investigate any shipment or part of a shipment, where acknowledgement is received within the period specified in Regulation 23 and shall immediately report to the Board.
(2) The shipment shall be monitored by the person who sends the radioactive material under sub-regulation (1) and shall prepare a report which shall be submitted to the Board within one week of completing the investigations.
PART VI
RADIATION SAFETY OFFICER
The management shall appoint a radiation safety officer at each ionizing radiation facility.
26. Duties of radiation safety officer
The radiation safety officer shall, in addition to other duties assigned to him, have the following functions:
(a) monitor the purchase and stock levels, the safe use, handling, transport, and storage of radioactive materials;
(b) inspect and monitor the facility for radiation safety, assist in the training of all relevant aspects of radiation protection;
(c) ensure that all workers are monitored regularly with personal dosimetry badges and a record system kept of the doses received; and
(d) ensure that all reports are made available to the Board.
PART VII
RADIOATIVE RELEASES TO THE ENVIRONMENT
(1) The release of radioactive materials to the environment shall be reported to the Board prior to the release.
(2) The levels released shall be below the exemption limits set by the Board.
The user shall comply with the authorised release limit, by setting up an adequate programme for environmental monitoring and accounting of the radioactive substances released.
PART VIII
EXPOSURE FROM CONSUMER PRODUCTS
No processing, manufacturing, commercialisation, export, import, and disposal of consumer products containing radioactive materials shall be done without authority from the Minister of Health.
PART IX
CESSATION AND SUSPENSION OF OPERATION, DECOMMISSIONING AND ABANDONMENT OF INSTALLATION
A person who holds a licence shall not-
(a) cease or suspend a licensed activity or the operation of licensed installation; or
(b) abandon or decommission an installation or waste management system without prior written approval or instruction of the Board.
Any approval or instruction issued under Regulation 29 shall prevail over a licence.
The Board may exempt any person from the provisions of any of these Regulations on the recommendations of the Radioisotope advisory Committee.
No person shall disclose any information unless authorised to do so under these Regulations.
Any person who contravenes any provision of these regulations shall be guilty of an offence and shall, on conviction, be liable to the penalties provided under the Act.
[Regulation 4]
EFFECTIVE DOSE EQUIVALENT LIMITS
1. Occupational Exposure Limits
|
-whole body (prospective) |
50 mSv per year |
|
-whole body (retrospective) |
100-150 mSv per year |
|
-whole body [accumulation to (age N-years)] |
(N-18) 3 50 mSv |
|
-Skin |
150 mSv per year |
|
-Hands |
750 mSv per year |
|
-Forearm |
300 mSv per year |
|
-Other organs, tissue & organ system |
150 mSv per year |
|
-Fertile woman (with respect to foetus) |
5 mSv in gestation period |
2. Dose Limits for the Public or Exposed Individuals
|
-individual or occasional |
5 mSv per year |
|
-population dose limit |
|
|
Genetic |
1.7 mSv average per year |
|
Somatic |
1.7 mSv average per year |
3. Emergency Dose Limits-Life Saving
|
-individual (older than 45 years if possible) |
1 Sv |
|
-hands and forearms |
2 Sv additional |
4. Emergency Dose Limits-Less Urgent
|
-individual |
250 mSv |
|
-hands and forearms |
1 Sv total |
|
-family of radioactive patients |
|
|
Individual (under 45 years) |
5 mSv per year |
|
Individual (over 45 years) |
<TS:0,NM,NO,0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO>50 mSv per year |
[Regulation 10]
DOSE EQUIVALENT FOR STUDENTS
1. Effective dose equivalent 0.5 mSv per year
2. Dose equivalent to single organ or tissue such as an eye or skin 5 mSv per year
[Regulation 17]
ANNUAL LIMITS OF INTAKE (MINIMUM) VALUES FOR SOME COMMON RADIONUCLIDES
|
Nuclide |
ALI (min) |
Nuclide |
ALI (min) |
|
H-3 water |
3.109 |
Sr-90 |
8.109 |
|
C-14 |
3.108 |
Sr-85 |
6.107 |
|
F-18 |
2.109 |
Sr-87m |
1.109 |
|
Na-22 |
2.107 |
Sr-89 |
5.109 |
|
Na-24 |
1.108 |
Sr-90 |
1.109 |
|
P-12 |
1.107 |
Y-90 |
2.107 |
|
P-33 |
1.108 |
Tc-99m |
3.109 |
|
S-35 |
8.107 |
Mo-99 |
2.108 |
|
C1-36 |
9.106 |
In-113m |
2.109 |
|
C1-38 |
6.108 |
Sb-124 |
1.108 |
|
K-42 |
2.108 |
I-123 |
1.108 |
|
K-43 |
2.108 |
I-125 |
1.106 |
|
Ca-45 |
3.107 |
I-129 |
2.105 |
|
Ca-47 |
3.107 |
I-130 |
1.107 |
|
Cr-51 |
7.108 |
I-131 |
1.106 |
|
Mn-52 |
3.107 |
I-132 |
1.108 |
|
Mn-52m |
1.109 |
Cd-109 |
1.106 |
|
Mn-54 |
3.107 |
Cd-115 |
3.107 |
|
Mn-58 |
2.108 |
In-111 |
2.108 |
|
Fe-52 |
3.107 |
Cs-129 |
9.108 |
|
Fe-55 |
7.107 |
Cs-130 |
2.108 |
|
Fe-59 |
1.107 |
Cs-131 |
8.108 |
|
Co-56 |
7.106 |
Cs-134 |
3.106 |
|
Co-57 |
2.107 |
Cs-134m |
4.109 |
|
Co-58 |
3.107 |
Cs-137 |
4.106 |
|
Co-60 |
1.106 |
Ba-131 |
1.108 |
|
Ni-63 |
1.108 |
Ba-133m |
9.107 |
|
Cu-64 |
4.108 |
Ba-135m |
1.108 |
|
Cu-67 |
2.108 |
La-140 |
2.107 |
|
Zn-62 |
5.107 |
Yb-169 |
2.107 |
|
Zn-65 |
1.107 |
Ir-192 |
8.106 |
|
Zn-69m |
2.108 |
Au-198 |
4.107 |
|
Ga-67 |
3.107 |
Hg-197 |
2.108 |
|
Ga-68 |
6.108 |
Hg-203 |
2.107 |
|
As-73 |
8.108 |
Tl-201 |
6.108 |
|
Se-75 |
6.107 |
Pb-210 |
9.103 |
|
Br-76 |
1.108 |
Pb-212 |
1.106 |
|
Br-77 |
6.108 |
Po-210 |
2.104 |
|
Br-82 |
1.108 |
Ra-226 |
2.104 |
|
Rb-81m |
9.109 |
Th-232 |
4.101 |
|
Rb-81 |
1.109 |
U-238 |
2.103 |
|
Rb-86 |
2.107 |
Am-241 |
2.102 |
|
Rb-88 |
7.108 |
Cm-244 |
4.102 |
|
Rb-89 |
1.109 |
Cf-252 |
1.103 |
[Regulation 17]
TYPES OF LICENCES
1. Licence to possess or use radioactive materials or device.
2. Licence to sell, loan or deal with radioactive material or radiation device.
3. Licence to dispose of radioactive materials.
4. Licence to import/export radioactive materials or device.
5. Licence authorizing administration of ionizing radiation to persons.
6. Certificate of Compliance/Acceptance for a building.
7. Licence authorizing an engineer, or technician to install, service or maintain irradiation device or radioactive material.
8. Radiation Premises Licence.
9. Certificate of Compliance or Acceptance of a new or modified radiation device or radiation premises.
REPUBLIC OF ZAMBIA
Form RPS/A/1
| Radiation Protection Board | For official use only |
| Ministry of Health | Licence No. |
| P.O. Box 30205 | Reg. No. |
| Lusaka | Receipt No. |
THE IONIZING RADIATION ACT, 1972 (Cap. 311)
APPLICATION FOR A LICENCE TO POSSESS RADIOACTIVE MATERIAL OR RADIATION DEVICE
1. Name of Applicant .....................................................Tel. No. Address
2. Name and address of owner where the radiation device will be used, stored or installed
3. Name and address of person responsible for radiation protection safety
Title ...................................................................... Reg. No. Qualification
Experience
4. List names of licensed users. Reg./Licence No. (use separate sheets where necessary)
PART "A" X-RAY EQUIPMENT
5. Identification:
Name of manufacturer
Model
Equipment control panel type
Serial No.
Tube head type ...................................................... Serial No. Tube insert type ..................................................... Serial No.
6. Type of installation:
(a) fixed/mobile
(b) combine/radiographic/fluoroscopic/photofluoroscopic/sine fluoroscopic/dental/other (specify)*
7. Rectification:
Single phase: self rectified/half wave rectified/full wave rectified
Three phase: six pulse/twelve pulse/contant potential, capacitor energy storage
8. For combined radiographic fluoroscopic:
Indicate whether with bucky radiographic/serial radiographic/tomographic/
fluorescent screen/image intensifier with spot camera from 70mm/100mm or optical viewer or television/cine camera for 16mm/35mm continuous operation/pulsed operation* (specify) maximum frame speed frames/second
9. Tube rating:
(a) For capacitor discharging equipment Peak tube voltage Max. quality charge coulombs or condenser capacitor uf
(b) For pulsed equipment:
Peak tube voltage kVp Max. tube current mA Max. exposure time sec. or
Max. tube current and exposure time mAs
10. Filtration:
Inherent mm Al equivalent
Added mm Al equivalent
Total mm Al equivalent
(Al = Aluminium)
11. Timer:
(a) Built-in monitoring system/filter safety switch*
(b) Automatic exposure control phototimer/ionizing type*
12. Tube Insert:
statonary anode/rotating anode* air cooled/oil cooled grid, controlled/non-grid controlled*
Fine focus
Broad focus
Heat storage capacity
Cooling rate
13. Mains voltage stabilization/tube voltage stabilization/tube current stabilization*
specify voltage fluctuation in output
14. Collimation: cones/single-leaf/multi-leaf/applicator/light beam*
15. Directions in which exposure can be made:
One direction/two direction/multi directional (indicate directions in the drawing of premises)*
16. Intended use of device
17. Cost of device
(*delete whichever is inapplicable)
PART "B"ACCELERATOR OR NEUTRON GENERATOR OR THERAPY MACHINE
(a separate form must be filled for each device).
18. Identification:
therapy unit.
Electron accelerator/heavy particle accelerator/neutron generator*/
Type of machine
Name of manufacturer
Model ........................................... Control panel Serial No. Date of Manufacture
19. Operational Factors: to be completed for all accelerators and neutron generators.
|
Primary Particle Accelerated |
Energy Range |
Peak Average Beam Current |
Target Material |
Target Thickens |
|
(a) |
||||
|
(b) |
||||
|
(c) |
||||
|
(d) |
20. To be completed for therapy machines.
|
Energy Values of primary for beam used for radiotherapy |
Related given dose rates field size |
Secondary radiaton produced |
Energy Values of secondary beam used forGive Dose 10 3 10 cm field size |
|
(a) |
|||
|
(b) |
|||
|
(c) |
|||
|
(d) |
21. Number of beam parts
22. Type of collimation
23. Number of afterload therapy units
24. Give total cost of the devices in this class
25. Intended use
26. Declaration:
I certify that the information given herein is true and correct to the best of my knowledge and belief.
Date
Signature of Applicant
Note: A fee is chargeable on this application for registration. A fee is chargeable annually for a licence.
PART C-RADIOACTIVE MATERIAL
27. Name and address of Unit/Department where radioactive material will be used Building .............................................................. Plot Number
Street
28. Radioactive material (give details of radioactive material) (that you will possess at one time-use separate paper if necessary)
|
Element mass Number |
Chemical/physical |
No. of sources |
Activity |
Date measured |
Model No. and name of manufacturer |
| ................... | ..................... | ..................... | .................... | ...................... | .......................... |
| ................... | ..................... | ..................... | .................... | ...................... | .......................... |
| ................... | ..................... | ..................... | .................... | ...................... | .......................... |
| ................... | ..................... | ..................... | .................... | ...................... | .......................... |
29. Describe the purpose of which radiation material will be used (if by-product material is the form of a sealed source, include the make and the model number of the storage container and/or device in which the source will be stored/and/or used
30. Radiation protection:
Describe radiation protection general measures. Also submit leak testing procedures where applicable, arrangements for performing initial radiation survey, service maintenance and repair for source equipment
31. Radioative waste management:
Submit detailed description of methods which will be used for disposing of radioactive wastes and estimates of the type and amount of activity involved
32. Declaration:
I certify that all information contained in this application including any supplements attached hereto is true and correct to the best of my knowledge and belief.
Date
Signature of Applicant
Note: A fee is payable for Registration. A fee is payable for a licence annually.
REPUBLIC OF ZAMBIA
Licence RPS/L/1
Licence No.
Registration
The Radiation Protection Board
Ministry of Health
P.O. Box 30205
Lusaka
LICENCE AUTHORISING THE BEARER TO POSSESS OR USE RADIOACTIVE MATERIALS OR DEVICES
Dr/Mr/Mrs/Miss/Messrs
Title
Plot No. .............................................................. P.O. Box
Premises ...................................................................... Street
Town .............................................................District
Province
is hereby licensed by the Radiation Protection Board to possess or use radiation devices or materials in accordance with Section 21 of the Ionizing Radiation Act and subject to the conditions imposed hereunder.
............................................ ..................................................
Chairman, Radiation Protection Board Secretary, RadiationProtection Board
Condition of Licence:
1. This licence is valid from ........................................ to...................................
2. The licensee is authorised to possess or use radioactive materials or devices listed below:
Date ............................................... Signature of Holder
REPUBLIC OF ZAMBIA
Licence RPS/A/3
The Radiation Protection Board
Ministry of Health
P.O. Box 30205
Lusaka
For official use only
Licence No.
Reg. No.
Receipt No.
THE IONIZING RADIATION ACT, 1972 (Cap. 311)
APPLICATION FOR DISPOSAL OF RADIOACTIVE MATERIALS
1. Name and address of applicant
2. Title
3. Licence or Registration Certificate No.
4. Premises where source has been used
Plot No. .......................................... Street
Town ...................................................... Province
5. Describe the method of disposal (e.g. river, sewage, solid waste, tipping, burial, incineration, or other methods).
6. What radiation protection measures have been taken to ensure that disposal method do not alter existing safety procedures and regulations?
7. To what extent will the disposal method affect the maximum permissible concentration of the disposal root
8. Identify the source to be disposed:
(a) Name of source Model
(b) Control panel type .............................................. Serial No.
(c) Others (specify)
| Element and Mass | Chemical/Activity | Name of Model |
| No. of Rad. | Physical | Manufacturer/ |
| Material | Form | No. Suppl. |
9. I, certify that the information given above is correct and true.
Signature
Full name
Title
Exempted owners must possess a disposal licence.
REPUBLIC OF ZAMBIA
Licence No.
Reg. No.
Radiation Protection Board
Ministry of Health
P.O. Box 30205
Lusaka
IONIZING RADIATION ACT, 1972 (Cap. 311)
A LICENCE AUTHORIZING DISPOSAL OF RADIOACTIVE
Dr/Mr/Mrs/Miss/Messrs
Of Licensed or registered under is authorized to dispose radioactive substances by the Radiation Protection Board under Section 21(1) of the Act and subject to the conditions laid hereunder.
Chairman, Radiation Secretary, Radiation
Protection Board Protection Board
Conditions of Licence:
1. This licence is valid from ........................................ to
2. The method of disposal is through solid waste/sewage/incineration/burial or confined storage*
3. The amount authorized for disposal is Bq.
4. The maximum permissible levels of concentration shall not exceed the limits set in the Radioactive Waste Management Regulations.
5. Others
Date ............................................... Signature of Holder
REPUBLIC OF ZAMBIA
IONIZING RADIATION REGULATIONS, 1992 (Cap. 311)
APPLICATION FOR RADIATION PREMISES LICENCE
1. Name of owner ............................................................ Tel. No.
2. Location of facility: Name of Unit/Dept.
Place: Plot No./Vehicle No.
Area/Town ................................................. Street
District ......................................... Name of Building
........................................................... Room(s) Floor
3. Name of person responsible for radiation safety
4. Is this a new/renewal application?
5. Type of facility: Medical/industrial/school/research/others* specify
6. Classification of facility
7. Type of installation: Enclosed installation/open installation*
(a) Enclosed installation: with aid diagram of plan to be attached, describe the appropriate facility or room with special reference to:
(i) Construction Material
(ii) Interlocks
(iii) Warning signals installed
(iv) Equipment layout
(v) Radiation shields
(vi) Fume holds
(vii) Remote handling equipment
(viii) Any other protective measures and devices
Note: Indicate in diagram or plan the directions in which exposure is possible.
(b) Open installation:
(i) State why an enclosed installation is not likely to be practicable
(ii) Indicate the distance from radiation source within which unauthorised persons are not allowed to enter
(iii) Indicate positive measures taken to maintain this degree isolation
(iv) How will you ensure that radiation workers involved will be adequately protected?
8. Enclose architectural drawings of the premises.
9. Declaration by owner:
I declare that the aforementioned is true and correct to the best of my knowledge and belief.
Date .................................... Signature of applicant
Note-A fee payable annually for a licence unless the applicant is exempted by the Board.
*Delete which ever is inapplicable.
REPUBLIC OF ZAMBIA
Licence No.
Reg. No.
Radiation Protection Board
Ministry of Health
P.O. Box 30205
Lusaka
THE IONIZING RADIATION REGULATIONS, 1972 (Cap. 311)
RADIATION PREMISES LICENCE
Name of Premises
Owner of Premises
Plot No. .......................................................... Street
Town .............................................................. Province
Postal Address
Department is licensed by the Radiation Protection Board as premises for housing, storing and installation of radioactive materials or radiation devices in accordance with Section 21(1) of the Act subject to the conditions set hereunder.
Chairman, Radiation Secretary, Radiation
Protection Board Protection Board
Condition of Licence:
1. This licence is valid from ........................................ to
2. The facility is licensed for housing, storing, and installation of (state specific type of device or material)
3. The owner named above shall comply with Section 22 of the Act.
Date ............................................... Signature of Holder
REPUBLIC OF ZAMBIA
Form RPS/A/5
For official use only
Licence No.
Reg. No.
Receipt No.
Radiation Protection Board
Ministry of Health
P.O. Box 30205
Lusaka
IONIZING RADIATION ACT, 1972 (Cap. 311)
APPLICATION FOR MODIFICATION OF RADIATION PREMISES, MATERIAL OR DEVICE
1. Name of Applicant
2. Premises address
3. Title of applicant
4. Licence No.
5. Describe nature and extent of modification, if it is for facility and technical drawings if for a device
6. What radiation protection measures have you taken to ensure that modifications do not alter existing safety procedures and regulations?
7. To what extent will modification affect the workload of the equipment operation within the facility?
8. Identify the device to be modified.
(a) Name of manufacturer ................................... Model
(b) Control panel type ................................. Serial No.
(c) Tube insert type ..................................... Serial No.
(d) Type of therapy Unit
(e) Others (specify)
9. I, certify that the information given above is correct and true.
Signature
Full name
Title
Note: A fee is charged on this application to all institutions and persons.
REPUBLIC OF ZAMBIA
Licence No.
Reg, No.
Radiation Protection Board
Ministry of Health
P.O. Box 30205
Lusaka
IONIZING RADIATION ACT, 1972
LICENCE AUTHORIZING MODIFICATION OF LICENSED RADIATION PREMISES, MATERIALS OR DEVICE
Dr/Mr/Mrs/Miss/Messrs
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>of .................................................................... Licence No. or Registration No, is licensed by the Radiation Protection Board to modify the radiation premises, material or device in accordance with Section 21 of the Act and subject to the conditions imposed hereunder.
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>Chairman, Radiation Secretary, Radiation
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>Protection Board Protection Board
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>Conditions of Licence:
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>1. This licence is valid from ........................................ to
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>2. Specific area or part to be modified For modification of the devices only registered installation service or maintenance personnel may make such modifications.
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>Date .............................................................. Signature
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>REPUBLIC OF ZAMBIA
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>Form RPS/A/6
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO> For official use only
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>Reg. No
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO> Licence
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>Receipt No.
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>Radiation Protection Board
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>Ministry of Health.
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>P.O. Box 30205
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>Lusaka
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>IONIZING RADIATION ACT, 1972
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>(Cap. 311)
<TS:0.197222,NM,NO,0.39375,NM,NO,0.590278,NM,NO,0.786806,NM,NO,0.984028,NM,NO,1.18125,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.96875,NM,NO,7.0625,NM,NO>APPLICATION FOR LICENCE TO SELL, LEASE, LOAN OR DEAL WITH RADIATION DEVICES OR RADIOACTIVE MATERIALS
1. Name of Applicant
2. Premises Address
3. Trade Licence No.
4. Type of radiation device or radioactive material you intend to sell, lease, loan, or deal with
5. Is the equipment new or old?
6. Name(s) of authorized installation, service or maintenance engineers/technologists
indicating their Reg. and Licence numbers
7. Is the application for a corporation or limited liability company/business
I, certifiy that the information given in this application including any supplements attached thereto is true and correct to the best of my knowledge.
Date ............................................... Signature of applicant
Note: A fee is payable annually for a licence.
REPUBLIC OF ZAMBIA
Form RPS/A/8
For official use only.
Licence No.
Reg. No.
Receipt No.
Radiation Protection Board
Ministry of Health
P.O. Box 30205
Lusaka
IONIZING RADIATION ACT, 1972
APPLICATION FOR LICENCE TO IMPORT/EXPORT* RADIATION DEVICES OR RADIOACTIVE MATERIALS
1. Name of Applicant
2. P.O. Box No. ....................................... Plot No.
3. Street ............................................... Town
4. District ....................................................... Province
5. Purpose for which the deivce or material will be used
6. Valid Licence number of registration of the consignee (purchaser)
7. Give a list of all the devices or radioactive materials you intend to import/export
8. Give details of storage and transportation compliance with the regulations on safe handling, storage and transport of radioactive materials (enclose additional information on separate sheet if need be)
9. Give the estimated sale price of the total items
10. Declaration:
I, certifiy that I have
read and understood the Regulations published by the Board and information given above is the truth and correct..
Date ............................................... Signature of applicant
Note: A fee is payable annually for the licence.
*Delete whichever is not applicable
REPUBLIC OF ZAMBIA
Licence No.
Reg. No.
Radiation Protection Board
Ministry of Health
P.O. Box 30205
Lusaka
IONIZING RADIATION ACT, 1972
A LICENCE AUTHORIZING THE BEARER TO IMPORT/EXPORT* RADIATION DEVICES OR RADIOACTIVE MATERIALS
Dr/Mr/Mrs/Miss/Messrs
Box No. ........................................... Plot No. Street
........................................................ Town District
....................................................... Province
is hereby licensed by the Radiation Protection Board to import/export* radiation devices or radioactive materials in accordance with Section 4 (e) of the Act and subject to the condition imposed hereunder.
| Chairman, Radiation | Secretary, Radiation |
| Protection Board | Protection Board |
Conditions of Licence:
1. Licence is valid from ........................................ to
2. The licensee is authorized to import/export the following radiation source(s)
3. Others
Date ............................................... Signature of Holder
*Delete whichever is not applicable
Date ............................................... Signature of Holder
REPUBLIC OF ZAMBIA
Form RPS/A/9
For official use only.
Reg. No.
Licence No.
Receipt No.
Radiation Protection Board
Ministry of Health
P.O. Box 30205
Lusaka
IONIZING RADIATION ACT, 1972
APPLICATION FOR LICENCE TO ADMINISTER IONIZNG RADIATION TO PERSONS
1. Dr/Mr/Mrs/Miss/Messrs
2. Address
3. Plot and Street Nos of Residence
4. Place and date of birth
5. Nationality
6. Qualification and where and when obtained
7. Testimonials covering the period of experience (photocopies should be supplied)
8. Is this new/renewal *application?
Date ............................................... Signature of applicant
Note: A fee is charged for the Licence.
*Delete where not applicable
REPUBLIC OF ZAMBIA
Licence No.
Reg. No.
Radiation Protection Board
Ministry of Health
P.O. Box 30205
Lusaka
IONIZING RADIATION ACT, 1972
LICENCE TO ADMINISTER IONIZNG RADIATION TO PERSONS
Dr/Mr/Mrs/Miss of
Qualification is licensed by the Radiation Protection Board to Administer ionizing radiation to persons as indicated:
x-rays/isotopes/electron generator/neutron generator for therapeutic/diagnostic work at (name of licensed facility) in accordance with the provisions of Section 21(1) of the Act.
Date ............................................... Signature of Holder
Chairman, Radiation Secretary, Radiation
Protection Board Protection Board
Conditions of Licence:
1. This licence is valid from ........................................ to
2. The licensee is authorised to administer ionizing radiation indicated above.
3. Others
*Delete where not applicable
REPUBLIC OF ZAMBIA
Form RPS/A/10
For official use only.
Reg. No.
Licence No.
Receipt No.
Radiation Protection Board
Ministry of Health
P.O. Box 30205
Lusaka
IONIZING RADIATION ACT, 1972
APPLICATION TO INSTALL, SERVICE OR MAINTAIN RADIATION DEVICES OR RADIOACTIVE MATERIALS
1. Mr/Mrs/Miss/Messrs
2. Address
(include plot number, building, street, etc)
3. Place and date of birth
4. Nationality
5. Academic Qualification
6. Experience
7. Is this new/renewal application?
Date ............................................... Signature of applicant
Note: A fee is charged for the licence.
REPUBLIC OF ZAMBIA
Licence No.
Reg. No.
Radiation Protection Board
Ministry of Health
P.O. Box 30205
Lusaka
IONIZING RADIATION ACT, 1972
A LICENCE AUTHORIZING THE BEARER TO INSTALL, SERVICE OR MAINTAIN RADIATION DEVICES OR RADIOACTIVE MATERIALS
Name of Qualification is licensed by the Radiation Protection Board to install, service or maintain radiation devices or radioactive materials in accordance with Section 21(1) of the Act and subject to the conditions imposed hereunder.
Conditions:
1. This licence is valid from ........................................ to
2. Others
Chairman, Radiation Secretary, Radiation
Protection Service Protection Service
Date ............................................... Signature of Holder
REPUBLIC OF ZAMBIA
For official use only.
Licence No.
Reg. No.
Receipt No.
The Radiation Protection Board
Ministry of Health
P.O. Box 30205
Lusaka
IONIZING RADIATION ACT, 1972
CERTIFICATE OF COMPLIANCE/ACCEPTANCE OF RADIATION PREMISES, DEVICE OR MATERIAL
This is to certify that the radiation premises/device/materials* of Licence No................................................................ Owned by.........................................................................................................................................................................
Has on this day ................................ of been inspected and found conforming with the Radiation Safety Regulations.
Chief Radiation Protection Officer
Date ............................................... Signature of Holder
*Delete whichever is not applicable
IONISING RADIATION PROTECTION (COMMENCEMENT), ORDER
[Section 1]
Arrangement of Paragraph
Paragraph
2. Commencement of Act No. 16 of 2005
SI 119 of 2006.
This Order may be cited as the Ionising Radiation Protection (Commencement) Order, 2006.
2. Commencement of Act No. 16 of 2005
The Ionising Radiation Protection Act, 2005, shall come into operation on the date of publication of this Order.
IONISING RADIATION PROTECTION (GENERAL) REGULATIONS
[Section 46]
[Currency mentioned in this regulation should be re-denominated as stipulated under S 4 of Re-denomination Act, 2012, read with S 29 of Bank of Zambia Act, 1996.]
Arrangement of Regulations
Regulation
PART I
PRELIMINARY
PART II
LICENSING
7. Variation of terms and conditions of licence
10. Application for renewal of licence
11. Suspension or cancellation of licence
13. De-commissioning of radioactive device
PART III
RADIATION PROTECTION
17. Guidance levels for medical exposure
18. Optimisation of protection and safety
PART IV
OCCUPATIONAL EXPOSURE
24. Local rules and supervision
25. Personal protective equipment
PART V
MEDICAL EXPOSURE
32. Justification of medical exposure
33. Optimisation of protection for medical exposure
34. Calibration, clinical dosimetry and quality assurance for medical exposure
35. Dose constraints for medical exposure
37. Maximum activity for patients in therapy on discharge from hospital
38. Investigation of accidental medical exposure
PART VI
PUBLIC EXPOSURE
41. Control of visitors to controlled areas
42. Measures for source of external exposure
43. Radioactive contamination in enclosed spaces
44. Monitoring programme for public exposure
45. Restriction of sale and supply of certain consumer products
PART VII
SAFETY AND SECURITY REQUIREMENTS
47. Design and procurement of sources
48. Accountability system and security of sources
49. Feedback of operating experience of equipment
PART VIII
EMERGENCY INTERVENTION
50. Responsibilities of licensee
51. Implementation of interventions to reduce accidental exposure
52. Protection of employees undertaking interventions
53. Release of radioactive materials into environmental
PART IX
TRANSPORTATION OF RADIOACTIVE MATERIAL
55. Transportation of radioactive materials
59. Investigation of shipment of radioactive material
PART X
GENERAL PROVISION
SI 98 of 2011,
SI 58 of 2014.
PART I
PRELIMINARY
These Regulations may be cited as the Ionising Radiation Protection (General) Regulations, 2011.
In these Regulations, unless the context otherwise requires–
“Authority” has the meaning assigned to in the Act;
“committed dose” means committed effective dose or committed equivalent dose;
“controlled area” means an area in which specific protection measures and safety provisions are required for– (a) controlling normal exposures or preventing the spread of contamination during normal working conditions and
(b) preventing or limiting the extent of potential exposures;
“critical group” means a group of person which is reasonably homogenous with respect to its exposure from a given radiation source and a given exposure pathway, and includes individuals receiving the highest effective dose or equivalent dose, as the case may be, by the given exposure pathway from the given source;
“deterministic effect” means an adverse effect on human health which is directly related to the dose of radiation received and which increases as the dose increases, and which has a threshold below which the effect does not occur;
“dose limit” has the meaning assigned to it in the Act;
“effective dose” means a measure used to estimate the risk resulting from exposure to radiation, and in human beings is found by calculating the sum of the equivalent doses in all tissues and organs of the body, each multiplied by the appropriate tissue – weighting factor;
“employee” means any person who works, whether full time, part time or on a casual basis, for an employer and who has recognised rights and duties in relation to occupational radiation protection;
“IAEA” means the International Atomic Energy Agency;
“licence” means an ionising radiation licence’
“licensee” means a holder of a licence;
“potential exposure” means exposure that is likely to occur from an accident at a source or an event or sequence of events of a probable nature, including an equipment failure or operating error, but is not intended or planned;
“radioactive material” has the meaning assigned to it in the Act;
“radionuclide material” has the meaning assigned to it in the Act;
“reference level” means an action, intervention, investigation or recording level connected with the determination of radiation quantities in the practice of radiation protection; and
“source” has the meaning assigned to it in the Act.
(1) These Regulations do not apply to–
(a) exposure from natural radio-activity in the body, cosmic radiation, unmodified concentrations of natural radio nuclides in raw materials and any other source that the Minister may specify;
(b) a practice or source which complies with the exemption levels prescribed in the Second Schedule;
(c) Apparatus containing radioactive substances which exceed the quantities or concentrations specified in the Second Schedule if the apparatus-
(i) is of a type approved by the Authority;
(ii) is constructed in the form of a sealed source; and
(iii) does not cause, in normal operating conditions, a dose rate exceeding 1µSv/h at a distance of 0.1m from any accessible surface of the apparatus or a dose exceeding 10µSv in a year to any member of the public; or
(d) the operation of any electrical apparatus, if it is of a type approved by the Authority and it does not cause, in normal operating conditions, a dose rate exceeding 1µSv/h at a distance of 0.1 m from any accessible surface of the apparatus.
(2) Paragraph (c) of sub-regulation (1) does not apply to the operation of any cathode ray tube intended for the display of visual images of an electrical apparatus operating at a potential difference not exceeding 30kV, if the cathode ray tube or electrical apparatus does not cause, in normal operating conditions, a dose rate exceeding 1µSv/h at a distance of 0.1m from any accessible surface of the cathode ray tube or electrical apparatus.
PART II
LICENSING
(1) An application for an ionising radiation licence shall be made in Form I set out in the First Schedule.
(2) A request for further particulars in respect of an application under this Part shall be in Form II set out in the First Schedule.
(1) The Board shall, within 30 days of the receipt of an application under regulation 4, reject the application, if the application does not meet the requirements of the Act or these Regulations.
(2) The Board shall, where it rejects an application under this Part, inform the applicant of the rejection in Form III set out in the First Schedule.
The Board shall, where it approves an application for a licence, issue a licence in Form IV set out in the First Schedule.
7. Variation of terms and conditions of licence
(1) An application for the variation of the terms and conditions of a licence shall be in Form V set out in the First Schedule.
(2) The Board shall, where it varies the terms and conditions of a licence, endorse the variation on the licence.
(1) An application for the transfer of a licence shall be made in Form VI set out in the First Schedule.
(2) The approval for the transfer of a licence shall be in Form VII set out in the First Schedule.
(3) The Board shall, where it rejects an application for the transfer of a licence, inform the applicant in Form III set out in the First Schedule.
(1) A licensee who decides not to continue with the activity to which the licence relates shall surrender the licence to the Board with Form VIII set out in the First Schedule.
(2) The Board shall, where a licence is surrendered under sub-regulation (1), cancel the licence.
10. Application for renewal of licence
(1) An application for the renewal of a licence shall be in Form IX set out in the First Schedule.
(2) The Board shall, where it rejects an application for the renewal of a licence, inform the applicant of the rejection in Form III set out in the First Schedule.
11. Suspension or cancellation of licence
(1) The Board shall, before suspending or cancelling any licence under the Act, inform the holder of its intention to suspend or cancel the licence in Form X set out in the First Schedule.
(2) A notification of the suspension or cancellation of a licence shall be in Form XI set out in the First Schedule.
The Board shall, where it has reasonable grounds to believe that a licensee has breached the terms and conditions of the licence, the provisions of the Act or a directive of the Board, issue an enforcement notice to the licensee in Form XII set out in the First Schedule.
13. De-commissioning of radioactive device
A notice of intention to de-commission in a radioactive device shall be in From XIII set out in the First Schedule.
An appeal against a decision of the Board shall be made in Form XIV set out in the First Schedule.
PART III
RADIATION PROTECTION
(1) The Board shall not authorise an activity likely to emit radiation unless it is of sufficient benefit to the exposed individual or to the public to offset the radiation harm that it could cause, taking into account the social, economic and other relevant factors.
(2) The following practices shall not be deemed as justified where they could result in an increase, by deliberate addition of radioactive substances or by activation, in the activity of the associated commodities or products:
(a) except for practices involving \medical exposures, or practices involving food, beverages, cosmetic or any other commodity or product intended for ingestion, inhalation or
percutaneous intake by, or application to, a human being;
(b) practices involving the frivolous use of radiation or radioactive substances in commodities or product such as toys;
(c) personal jewellery or adornments; and
(d) any other practices determined by the Authority as unjustified.
(1) The normal exposure of individuals shall be restricted so that neither the total effective dose nor the total equivalent dose to relevant organs or tissues, caused by the possible combination of exposures from authorised practices, exceeds any relevant dose limits specified in the Third Schedule.
(2) The dose limits referred to in sub-regulation (1) shall not apply to medical exposures from authorised practices.
17. Guidance levels for medical exposure
(1) The guidance levels for medical exposure specified in the Fourth Schedule shall be used by medical personnel in the conduct of diagnostic and therapeutic procedures involving exposure to radiation and in the optimization of protection of patients.
(2) The guidance levels referred to in sub-regulation (1) shall be established by relevant professional bodies, in consultation with the Authority, to provide an indication on what dose are achievable with current good practices.
(3) The guidance levels referred to in sub-regulation (1) shall be applied with flexibility to allow higher exposures if these are indicated by sound clinical judgments and shall be revised as required by technological and scientific developments.
18. Optimization of protection and safety
(1) Radiation safety shall be optimised, in relation to exposures form any particular source within a practice, so that the magnitude of individual dose, except for therapeutic medical exposures, the number of people exposed and the likelihood of incurring exposures is kept as low as reasonably achievable, economic and social factors being taken into account, within the restriction that the dose to individuals delivered by the source is subject to dose constraints.
(2) The process of optimization of protection and the safety measures referred to in sub-regulation (1) may range from intuitive qualitative analyses to quantitative analyses using decision aiding techniques, but it shall be sufficient to take all relevant factors into account in a coherent manner so as to contribute to achieving the following:
(a) to determine optimised protection and safety measures for the prevailing circumstances, taking into account the available protection and safety options as well as the nature, magnitude and likelihood of exposures; and
(b) to establish criteria, on the basis of the results of the optimization, for the restriction of the magnitudes of exposures and of their probabilities by means for preventing accidents and mitigating their consequences.
(1) Except for medical exposure, the optimization of the radiation safety measure associated with a given practice shall satisfy the condition that the resulting doses to the individuals of the critical group do not exceed dose constraints which are equal to the dose limits specified in the Third Schedule.
(2) A licensee shall, where any source is capable of releasing, or is likely to release, radioactive substances into the environment, establish the dose constraints so that the prospective annual doses to members of the public, including people distant from the source and people of future generations, summed over all exposure pathways, including contributions by other practices and sources, are unlikely to exceed the dose limit specified in the Third Schedule or lower values established by the Authority.
The Annual Limit on Intake (ALI) shall be as prescribed in the IAEA Safety Series No. 115.
PART IV
OCCUPATIONAL EXPOSURE
(1) A licence or employer who is engaged in an activity that involves or is likely to involve occupational exposure which is not excluded from these Regulations shall be responsible for the protection of the employee against any occupational exposure.
(2) A licensee or employer who employs a person in an activity that involves or is likely to involve occupational exposure shall ensure that-
(a) the occupational exposure is limited to the specifications in the Third Schedule;
(b) radiation safety is optimised in accordance with these Regulations;
(c) the policy of the organisation on occupational protection and safety complies with these Regulations;
(d) the facilities for radiation safety include a personal protection device and functional monitoring equipment;
(e) radiation safety and health surveillance services are provided, to the employees, through qualified experts;
(f) the employees are consulted through the employees’ representatives, if necessary, on the measures to be taken to achieve the required radiation protection and safety;
(g) the licensee or employer promotes a safety culture within the organisation; and
(h) the employees are trained on radiation safety matters.
(3) Where an employee is to be engaged in work that involves or is likely to involve a source which is not under the control of their employer, the licensee responsible for the source shall-
(a) as a precondition for the engagement of the employee, obtain from the employer of the employee, information of that employee’s previous occupational exposure history and any other relevant information for the purposes of providing radiation protection and safety;
(b) provide the same protective and safety measures to the employee as those provided for the employees of the licensee; and
(c) savail information on measurement of radiation doses emitted by a radioactive source and any other relevant information to the employer of the employee for purposes of demonstrating that the level of protection provided to the employee is in compliance with these Regulations.
(4) A licensee or employer shall ensure that an employee under that licensee’s or employer’s responsibility who is exposed to radiation from a source other than a natural source, which is not directly related to that employee’s employment, receives the same level of protection provided to members of the public.
(5) A licensee or employer shall ensure that an employee-
(a) is informed of the employee’s obligations to protect others against radiation;
(b) complies with the application rules and procedures for protection, safety and security;
(c) properly uses the monitoring device, protective equipment and clothing provided by the licensee or employer;
(d) abstains from any wilful action that places or is likely to place the employee or other people in circumstances that contravene these Regulations; and
(e) promptly reports to the licensee or employer any circumstances that could adversely affect the safety or security conditions of the place of work.
(6) A licensee or employer shall record any report received from an employee that identifies any circumstances that could affect the safety and security conditions of the place of work and shall take appropriate remedial measures.
(1) The conditions of service of an employee shall be independent of the existence or the possibility of occupational exposure, except where the conditions facilities the enhancement of the occupational health and safety of the employee.
(2) A licensee or employer shall not, as a substitute for the provisions of adequate protection and safety measures in compliance with these regulations, offer an employee preferential conditions of service in consideration for absence of adequate protection and safety measures.
(3) A licensee or employer shall adjust the working conditions of a female employee who is pregnant to ensure the protection and safety of the foetus from occupational exposure and the level of protection and safety given to the foetus shall be the same level of protection given to members of the public, as specified in the Third Schedule.
(4) A licensee or employer shall make every reasonable effort to provide an employee with a suitable or alternative place of work or employment in circumstance where it has been determined, either by the Authority or in the framework of the health surveillance programme required by these Regulations, that the employee, for health reasons, should no longer continue in employment involving occupational exposure.
(5) A licensee or employer shall not subject a person under the age of 16 years to occupational exposure.
(6) A licensee or employer shall not allow a person who is under the age of 18 years to work, for purposes of training, in a controlled area unless that person is under supervision.
(1) A licensee or employer shall designate a controlled area where specified protective measures or safety and security provisions are, or would be, required for the purposes of-
(a) controlling normal exposures or preventing the spread of a contamination during normal working conditions; and
(b) preventing or limiting the extent of potential exposure.
(2) A licensee shall, in relation to a controlled area-
(a) determine the boundaries of the 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;
(b) delineate the controlled area by physical means or, where this is not reasonably or practicable, by other suitable means;
(c) where a source is brought into operation or energised only intermittently or is moved from place to place, delineate the controlled area by means that are appropriate under the prevailing circumstances and specify exposure times;
(d) display a warning symbol, recommended by the International Organisation for Standardisation (ISO) and appropriate instructions at access points and other appropriate locations within the controlled area;
(e) establish occupational protection, safety and security measures, including local rules and procedures that are appropriate for the controlled area;
(f) restrict access to the controlled area by means of administrative procedures, such as the use of employee access control, and by physical barriers, for which the degree of restriction is commensurate with the magnitude and likelihood of the expected exposure; and
(g) provide at entrances and exits of the controlled area appropriate means for change of clothing, monitoring of contamination and personal de-contamination.
(2) A licensee or employee shall ensure that in standard working procedures with sources the expected contamination does not exceed the effective dose specified in the Third Schedule.
(3) A licensee or employee shall designate an area not designated as a controlled area as a supervised area, where occupational exposure conditions shall be kept under review.
(4) A licensee shall, in designating an area as a supervised area take into account the nature and extent of radiation hazards in those areas.
(5) A licensee shall periodically review the protection measures or safety provisions, including the boundaries of controlled and supervised areas.
24. Local rules and supervision
(1) A licensee or employer shall, in consultation with the employees-
(a) establish in writing, such rules and procedures as are necessary to ensure adequate levels of protection and safety for the employees and other persons in the workplace, and for the security of sources; and
(b) ensure that any work involving occupational exposure is adequately supervised and steps are taken to ensure that the rules, procedures, protective measures and safety provisions are observed.
(2) A licensee shall include in the rules and procedures referred to in sub-regulation (1), the values of the authorised level, investigation level or other reference level and the procedure to be followed in the event that such level is exceeded.
(3) A licensee or an employee shall-
(a) provide to the employees adequate information on the health risks likely to arise from occupational exposure, and adequate instruction and training on protection and safety; and
(b) provide to female employees who are likely to enter any controlled area or supervised area appropriated information on-
(i) the risk to the embryo or foetus;
(ii) the importance for a female employee to notify the employer as soon as she suspects that she is pregnant; and
(iii) the risk to an infant ingesting radioactive substances by breast feeding;
(c) provide to the employees appropriate information, instruction and training to deal with an emergency; and
(d) keep records of the training provided to the employees.
25. Personal protective equipment
(1) A licensee or an employer shall-
(a) minimise the need for relying on administrative controls and personal protective equipment for protection and safety during normal operations by providing appropriate well engineered controls and satisfactory working conditions;
(b) ensure that employees are provided with suitable and adequate personal protective equipment, including-
(i) protective clothing;
(ii) protective respiratory equipment with information on its protection characteristics and instructions on its proper use; and
(iii) protective aprons, gloves and organ shields;
(3) A licensee or an employer shall arrange for regular testing and maintenance to be carried out on all personal protective equipment, including special equipment for use in the event of accidents and interventions.
(4) A licensee or an employer shall take into account the following factors when assigning personal protective equipment for a given task:
(a) medical fitness to sustain possible extra physical effort while using the protective equipment; and
(b) additional work time or inconvenience or additional non radiological risks associated with the use of the protective equipment.
(1) A licensee or an employer shall arrange for the assessment of the occupation exposure of an employee and shall ensure that adequate arrangements are made for the provision of such services by a dosimetry laboratory approved by the Authority.
(2) A licensee or an employee shall take individual monitoring for an employee who is employed in a controlled area and where individual monitoring is not feasible, the occupational exposure of the employee 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 employee.
(3) A licensee or an employee shall, where an employee is engaged in a supervised area or enters a controlled area occasionally, assess the occupational exposure of the employee 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 by considering the magnitude and possible fluctuations of exposure levels and the likelihood and magnitude of potential exposures.
(5) A licensee or an employer shall ensure that an employee who may be exposed to radioactive contamination, including an employee who uses protective respiratory equipment, is identified and shall arrange for appropriate monitoring to the extent necessary to demonstrate the effectiveness of the protection provided and to assess the intake of radioactive substances or the committed dose, as appropriate.
(6) A licensee or an employer shall keep records of exposure which shall be made available to the employees and the Authority.
(1) A licensee or an employer, 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 source.
(2) The programme for the monitoring of the workplace shall specify-
(a) the quantities to be measured;
(b) where and when the measurements are to be made and of what frequency;
(c) the most appropriate measurement methods and procedures; and
(d) the reference levels and the measures to be taken if they are exceeded.
(3) The nature and frequency of monitoring of the workplace referred to in sub-regulation (1), shall be sufficient to enable-
(a) the evaluation of the radiological conditions in the workplaces;
(b) the assessment of the exposure of the employees in controlled areas and supervised areas;
(c) the review of the classification of the controlled and supervised areas; and
(d) the assessment of the levels of ambient dose equivalent, airborne and surface activity concentration, including their expected fluctuation, the likelihood and magnitude of potential exposures.
(4) A licensee shall keep appropriate records of the findings of the workplace monitoring programme, which shall be made available to the employees.
(1) A licensee or employer shall, in accordance with the rules established by the Authority, make arrangements for health surveillance, based on the general principles of occupational health, designated to assess the initial and continuing fitness of an employee in relation to the employee’s tasks.
(2) A licensee or an employer shall take medical history or otherwise health surveillance of an employee before that employee takes employment in a radiation related workplace.
(1) A licensee or an employee shall maintain records of exposure for each employee for whom assessment of occupational exposure is required under regulation 26.
(2) An employee’s exposure record shall include information on-
(a) the general nature of the work resulting in exposure, the external doses and intakes at, or above, the relevant records levels and the data upon which the dose assessments are based;
(b) the periods of employment with different employers, if any, and if the corresponding doses and intakes in each period of employment; and
(c) the internal and external doses due to emergency interventions or accidents, which shall be distinguished from doses received during work in normal conditions.
(3) A licensee or an employer shall-
(a) provide an employee access to information of their own exposure records and workplace monitoring, where appropriate; and
(b) upon request by the Authority or other persons or organisations with a demonstrated need for the records referred to in paragraph (a) provide access to employee exposure records, with care and attention to the maintenance of appropriate confidentiality.
(4) A licensee or employer shall retain the employee’s record until the employee attains the age of 75 years, and for not less than 30 years the termination of the work involving occupational exposure.
(1) A licensee shall, where a practice which is justified and for which radiation safety is optimised requires a temporary change in the dose limit requirements specified by these Regulations, apply to the Authority for approval to change the dose limit.
(2) The application made by the licensee under sub-regulation (1) shall include information to demonstrate that-
(a) all reasonable efforts have been made to reduce exposures and optimise radiation safety provisions in accordance with the requirements of these Regulations; and
(b) the relevant employers and employees, through their representatives where appropriate, have been consulted on the need for and the conditions of the temporary change in dose limit requirements.
(3) Any temporary change in the dose limit requirements of these Regulations shall be limited to specified work areas and shall be in accordance with the time and dose limit for special circumstances specified in the Third Schedule.
PART V
MEDICAL EXPOSURE
(1) A licensee shall ensure that–
(a) a patient is not administered a diagnostic or therapeutic medical exposure, unless the exposure is prescribed by a medical doctor or dental surgeon;
(b) medical doctors and dental surgeons are assigned the primary obligation of ensuring overall patient protection and safety in the prescription of, and during the delivery of, medical exposure;
(c) medical personnel are available as needed and are trained in discharge the assigned tasks in the diagnostic or therapeutic procedures that the medical doctor or dental surgeon prescribes;
(d) for therapeutic uses of radiation, including teletherapy and brachytherapy, the calibration, dosimetry and quality assurance requirements of these Regulations are conducted by, or under, the supervision of a qualified expert in radiotherapy physics;
(e) the exposure of individuals incurred knowingly while helping voluntarily, other than in their occupation, in the care, support or comfort of patients is constrained as specified in the Fourth Schedule; and
(f) personnel engaged in diagnostic or therapeutic uses of radiation are well trained and qualified.
(2) A licensee shall, to the extent practicable, ensure that for diagnostic uses of ionising radiation, the imaging and quality assurance requirements of these Regulations are met with the advice of a qualified expert in radio-diagnostic physics, nuclear medicine physical and radiopharmacy in the compounding of radio-pharmaceuticals, as appropriate.
(3) Medical personnel shall promptly inform the licensee of any deficiencies or needs concerning compliance with these Regulations with respect to the protection and safety of patients, and shall take such measures as may be necessary to ensure the protection and safety of patients.
32. Justification of medical exposure
(1) A medical doctor or dental surgeon shall consider the justification of the medical exposure prescribed by weighing the diagnostic or therapeutic benefits that the medical exposure produces against the radiation detriment, it may cause taking into account the benefits and risks of available alternative techniques that do not involve medical exposure.
(2) A radiological examination for occupational, legal or health insurance purposes undertaken without reference to clinical indications shall not be treated as justified 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 relevant professional bodies.
(3) Mass screening of population groups involving medical exposure shall not be treated as justified unless the expected advantages for the individuals examined or for the population as a whole are sufficient to compensate for the economic and social costs, including the radiation detriment.
(4) The exposure of humans for medical research shall not be treated as justified unless it is-
(a) undertaken in accordance with the provisions of the Helsinki Declaration (1964) and complies with the guidelines for its application prepared by the Council for International Organisations of Medical Sciences (CIOMS) (1993) and World Health Organisation (WHO) (1997); and
(b) subject to the advice of the licensee’s ethical review committee and to any other application law.
33. Optimization of protection for medical exposures
A licensee shall, in addition to satisfying the general requirements for optimization of radiation safety specified in these Regulations, in cooperation with the suppliers of radiation equipment, meet the prescriptive design and operational requirements specified in the First Schedule.
34. Calibration, clinical dosimetry and quality assurance for medical exposure
(1) A licensee shall ensure that-
(a) the calibration of sources used for medical exposure is traceable to a standards dosimetry approved by the Authority;
(b) each type of radiotherapy equipment is calibrated in terms of the relevant dosimetric qualities and irradiation conditions;
(c) unsealed sources for nuclear medicines procedures are calibrated in terms of activity of the radio-pharmaceutical to be administered; and
(d) calibration of equipment are carried out at the time of commissioning of a source, after any maintenance procedure that may affect the calibration, at least once in a year.
(2) A licensee shall ensure that representative values of clinical dosimetry parameters are determined and documented.
(3) Quality assurance programmes for medical exposures shall include-
(a) measurements of the physical parameters of the radiation generators, imaging devices and irradiation installation at the time of commissioning and periodically thereafter;
(b) verification of the appropriate physical and clinical factors used in patient diagnosis or treatment;
(c) written records of relevant procedures and results;
(d) verification of the appropriate calibration and conditions of operation of dosimetry and monitoring equipment; and
(e) as far as possible, regular and independent quality audit reviews of the quality assurance programmes for radiotherapy procedures.
35. Dose constraints for medical research
(1) The optimization of protection of persons exposed for medical research purposes, where the medical exposure does not produce direct benefit to the exposed individuals, shall be subjected to individual does constraints established on a case by case basis by an ethical review committee or other institutional body assigned a similar function.
(2) A licensee shall limit any dose to individuals incurred while helping voluntarily, 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 Fourth Schedule.
(1) A licensee shall ensure that guidance levels for medical exposure, determined as specified in regulation 34, are revised as technology improves and are used as guidance by medical personal so that-
(a) corrective measures are taken if the doses or activities fall substantially below the guidance levels, resulting in a decrease of medical benefit to patients by ineffective diagnostic information or insufficient therapeutic dosage; and
(b) review measures are considered if doses or activities exceed the guidance levels as an input to ensuring optimised protection of patients and maintain appropriate levels of good practice.
(2) A licensee shall, during the period in which the guidance levels for medical exposures are determined pursuant to regulation 17, ensure that the performance of diagnostic radiology and nuclear medicine equipment is assessed on the basis of comparison with the guidance levels provided in the Fourth Schedule.
37. Maximum activity for patients in therapy on discharge from hospital
(1) In order to restrict the exposure of any member of the household of a patient who has undergone a therapeutic procedure with sealed or unsealed radionuclides and of members of the public, the patient shall not be discharged from hospital before the activity of radioactive substances in the body falls below the level specified in the Fourth Schedule, unless otherwise justified and the justification is documented.
(2) Medical personnel shall provide written instructions to a patient who undergoes therapeutic procedures concerning contact with other persons and necessary precautions for radiation protection.
38. Investigation of accidental medical exposures
(1) A licensee shall promptly investigate the following incidents:
(a) any therapeutic treatment delivered to the wrong patient or the wrong tissue, using the wrong pharmaceutical, or with a dose or dose fractionation differing substantially from the value prescribed by the medical doctor or dental surgeon;
(b) any diagnostic exposure substantially greater than intended or resulting in doses repeatedly and substantially exceeding the established guidance levels; and
(c) any repeated equipment failure, accident, error, mishap or other unusual occurrence with the potential for causing a patient exposure significantly different form that intended;
(2) A licensee shall, with respect to any investigation required-
(a) calculate or estimate the doses received and their distribution within the patient;
(b) indicate the corrective measures required to prevent recurrence of an incident;
(c) implement all the corrective measures that are under the licensee’s responsibility;
(d) notify the Authority, by telephone, electronic mail, facsimile or any other efficient means of communication as soon as practicable, but not later than 24 hours after discovery, of any incident which has the potential for, or has resulted in, serious injury or death of a patient, or which involve more than one patient
(e) submit to the Authority, within 30 days after discovery of the incident, a written report which states the cause of the incident and includes information on the doses, corrective measures and any other relevant information; and
(f) inform the patient and the patient’s doctor about the incident.
A licensee shall keep and make available, as appropriate, records of equipment calibration, clinical dosimetry and quality assurance, as well as any other necessary information to allow assessments of these doses received by patients.
PART VI
PUBLIC EXPOSURE
(1) A licensee shall, with respect to sources of radiation under the licensee’s responsibility, establish, implement and maintain-
(a) radiation safety polices, procedure and organisation arrangements to control public exposure to radiation.;
(b) measures for ensuring-
(i) the optimization of the protection of members of the public which is attributable to the sources of radiation under the licensee’s control; and
(ii) 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 specified in these Regulations.
(c) measure for ensuring the safety and security of the sources, in order that the likelihood of public exposure is controlled in accordance with the requirements of these Regulations;
(d) measures commensurate with the magnitude and likelihood of the potential exposure;
(e) appropriate radiation safety training, and periodic re-training, of the personnel responsible for the protection of the public;
(f) appropriate monitoring equipment and surveillance programmes to assess public exposure to radiation; and
(g) adequate records of the surveillance and monitoring programmes.
41. Control of visitors to controlled areas
A licensee shall–
(a) ensure that visitors are accompanied, in any controlled area, by a person knowledgeable about the radiation safety measures for that area;
(b) provide adequate information and instructions to visitors before they enter a controlled area so as to ensure the appropriate protection of the visitors and other persons in the controlled area; and
(c) ensure that the entry of visitors to a controlled area is restricted and that appropriate signs are posted in the controlled area.
42. Measures for sources of external exposure
A licensee shall ensure that where a source of external irradiation is likely to cause exposure to the public-
(a) prior to commissioning the installation, obtain the approval of the Authority in relation to the floor plans and equipment arrangement for the installation and all significant modifications to existing installation using the source of external irradiation;
(b) specify dose constraints for the operation of the source are established as determined by the Authority; and
(c) shielding and other protective measures that are optimised in accordance with the requirements of these Regulations are provided, as appropriate, for restricting public exposure as determined by the Authority.
43. Radioactive contamination in enclosed spaces
A licensee shall ensure that–
(a) for sources of irradiation for which the licensee is responsible, measures that are optimised in accordance with the requirements of these Regulations are taken for restricting public exposure in areas accessible to the public; and
(b) specific containment provisions are established for the construction and operation of the sources of irradiation in order to avoid or minimise the spread of contamination in areas accessible to the public.
44. Monitoring programme for public exposure
A licensee shall–
(a) establish and carry out a radiation monitoring programme commensurate with the type of, and risks associated with, the sources of irradiation under the licensee’s responsibility, to ensure that the requirements of these Regulations are met and to assess the exposure of members of the public to irradiation and discharges of radioactive substances.
(b) keep a record of the results of the radiation monitoring programmes and report the monitoring results to the Authority annually; and
(c) promptly inform the Authority of any results which lead or could lead to an increase of public exposure to radiation.
45. Restriction of sale and supply of certain consumer products
(1) Consumer products that are sources of radiation shall not be sold or supplied to members of the public unless-
(a) they are exempt from the application of these Regulation under regulation 3; or
(b) they are authorised by the Authority for use by members of the public.
(2) An importer of any consumer product that is a source intended for sale or supply to the public shall include in the application for a licence, a copy of the licence or other relevant authorization issued by the regulatory authority in the country of manufacture or origin which authorises the supply of the consumer product to members of the public in that country.
(3) An importer of any consumer product that is a source intended for sale or supply to the public shall ensure that-
(a) legible labels are visibly and firmly affixed to the consumer product and its package, stating, in English, that-
(i) the product contains radioactive materials; and
(ii) the sale of the product to the public has been authorised by the relevant regulatory authority; and
(b) basic information and instructions on the precautions of use and disposal of the product, written or translated in the local language, are made available with the product.
PART VII
SAFETY AND SECURITY REQUIREMENTS
(1) A licensee shall ensure the safety of the sources under the licensee’s responsibility, from the date of their acquisition throughout their entire operational life and up to their final disposal.
(2) A licensee shall ensure that adequate provision for protection and safety commensurate with the magnitude and likelihood of the potential exposure is applied to the source under the licensee’s responsibility so as to-
(a) compensate for or correct a failure by the source;
(b) prevent accidents that may cause unintended exposure to radioactive material;
(c) mitigate the consequences of any accident, should it occur; and
(d) restore the source to safety conditions after any accident.
(3) A licensee shall ensure that the location, design, construction, assembly, commissioning, operating, maintenance and de-commissioning of source of radiation are based on sound engineering practice which-
(a) takes into account approved codes and standards and technical and scientific developments in the industry;
(b) is supported by reliable managerial and organisational features; and
(c) includes adequate safety margins in the design, construction and operation of sources.
47. Design and procurement of sources
A licensee shall, in collaboration with suppliers of equipment containing radiation generations or sources-
(a) ensure, on procurement of the equipment, that it conforms to the International Electro-Technical Commission (IEC) and the International Standards Organisation (ISO) or equivalent standards as may be approved by the Authority;
(b) ensure that the equipment is tested by the Authority to demonstrate compliance with the appropriate specifications;
(c) conduct a safety assessment of the equipment, either generic or specific, according to the requirements of these Regulations;
(d) ensure that performance specifications and operating and maintenance instructions, including protection and safety instructions, are provided in a language approved by the Authority and in compliance with the relevant IEC and ISO standards and that the information is translated into the local language, where appropriate; and
(e) 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 (d).
48. Accountability and security of sources
(1) A licensee shall maintain an accountability system which shall include records of-
(a) the location and description of each source of radiation for which the licensee is responsible; and
(b) the activity and form of each radioactive substance for which the licensee is responsible;
(2) A licensee shall make arrangements for the sources of radiation under the licensee’s responsibility to be kept secure by ensuring that-
(a) the control of the source is not relinquished without compliance with the terms and conditions of the licensee and without informing the Authority regarding any de-controlled, lost, stolen or missing source;
(b) a source is not transferred to another person who does not hold a valid licence;
(c) records are maintained of source inventory, including records of receipt, transfer and disposal of sources; and
(d) a periodic inventory of sources is conducted at intervals specified in the licence to confirm that they are in their assigned locations and are secure.
49. Feedback of operating experience of equipment
(1) A licensee shall ensure that information on the normal operation performance and abnormal conditions and events significant to radiation safety and security is disseminated or made available to the Authority and other relevant parties, including other users, as specified by the Authority.
(2) A licensee shall make appropriate arrangements with the suppliers or sources of radiation to establish and maintain mechanisms for the transfer from the licencees to the suppliers of any information on the use, maintenance, disposal and malfunctioning of that source relevant for future improvements in the design and construction of the sources.
PART VIII
EMERGENCY INTERVENTION
50. Responsibility of licensee
(1) A licensee shall, where an authorised practice or source within a practice has a potential for accidents likely to result in exposure of the public to radiation prepare an emergency plan appropriate of the sources and its associated risks.
(2) An emergency plan shall-
(a) characterise 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 similar type;
(b) identify the various operating and other conditions of the source which could lead to the need for intervention;
(c) describe the methods and instructions for assessing the accident and its consequences on and off the site;
(d) provide for protection and mitigating actions and assignment of responsibilities for initiating and discharging such actions;
(e) provide for rapid and continuous assessment of the accident and determine the need for protective actions;
(f) allocate responsibilities for notifying the relevant authorities and for initiating intervention;
(g) provide procedures, including communication arrangements, for contacting any relevant intervening organisation and for obtaining assistance for fire fighting, medical, police and other relevant services;
(h) provide for training the personnel involved in implementing emergency plans and the rehearsal at appropriate intervals in conjunction with the relevant authorities; and
(i) provide for periodic review and updating of the plan.
(3) A licensee shall ensure that an emergency plan defines onsite responsibilities and takes account of offsite responsibilities of other intervening organisations appropriate for the implementation of the emergency plan.
(4) A licensee shall, where an accident occurs from any source, take the necessary protective measures required for the protection of the public from exposure and such measures as the Authority may determine to protect, mitigate or remediate a hazardous situation involving the sources.
51. Implementation of interventions to reduce accidental exposure
(1) A licensee shall ensure that the protective actions or remedial actions aimed at reducing or averting accidental exposures are only undertaken if they are justified, taking into account health, social and economic factors.
(2) The form, scale and duration of any intervention shall be optimised so as to produce the maximum net benefit under the prevailing social and economic circumstances.
(3) A licensee shall, where an accident requiring intervention occurs, or is likely to occur, immediately notify the Authority of-
(a) the situation and its expected evaluation;
(b) the measures taken to terminate the accident and to protect the employees and the members of the public; and
(c) the exposures incurred and that are expected to be incurred.
52. Protection of employees undertaking interventions
(1) An employee undertaking an intervention shall be exposed in excess of the maximum single year dose limit for occupational exposure specified in the Third Schedule, except-
(a) where the employee undertakes the interventions for the purpose of saving life or preventing serious injury; or
(b) where the employee is undertaking the intervention to prevent the development of catastrophic conditions.
(2) A licensee undertaking any intervention shall take all reasonable measures to keep doses to the employees below twice the maximum single year dose limit, except for life saving intervention, in which the licensee shall keep doses below ten times the maximum single year dose limit in order to avoid deterministic effect on health.
(3) An employee undertaking interventions in which the doses may approach or exceed ten times the maximum single year dose limit shall do so only when the benefits to others clearly outweigh their own risk.
(4) An employee who undertakes interventions in which the dose exceeds the maximum single year dose limit shall do so as a volunteer and shall be clearly informed in advance of the associated health risk, and shall, to the extent feasible, be trained in the intervention required.
(5) A licensee shall, at the end of an emergency intervention, ensure that the employees undertaking the recovery operations, such as repair to equipment and buildings, waste disposal or de-contamination are subjected to the requirement
(6) A licensee shall-
(a) take reasonable steps to provide appropriate protection to the employees undertaking any emergency intervention and to assess and record the doses received by the employees; and
(b) inform the employees at the end of the intervention of the doses received and the consequent health risk.
(7) An employee shall not be precluded from incurring further occupational exposure because of the doses received in an emergency intervention, except that qualified medical advice shall be obtained before any further exposure, at the employee’s request or where an employee, during an emergency intervention, receives a dose exceeding ten times the maximum single year dose limit.
53. Release of radioactive materials into environment
(1) A licensee shall inform the Authority immediately of the release of radioactive materials into the environment.
(2) The levels of radioactive materials released into the environment shall be below the exempt limits set by the Authority.
(3) A licensee shall comply with the exempt limits by establishing an environmental monitoring programme and accounting for the release of the radioactive materials.
PART IX
TRANSPORTATION OF RADIACTIVE MATERIAL
In this Part, “IAEA Transport Regulations” means the International Atomic Energy Regulation for the Transport of Radioactive Material (IAEA Safety Standards Series No. ST-1).
55. Transportation of radioactive materials
(1) A person delivering radioactive materials to a carrier or any person transporting radioactive materials within, through or into the country, shall comply with the IAEA Transport Regulations.
(2) The packaging and design for the transportation of radioactive materials, through or into the country shall comply with the requirements of the IAEA Transport Regulations.
Any radioactive materials stored in transit shall be stored in accordance with the IAEA Transport Regulations and handled in transit in accordance with instructions issued by the Authority.
A licensee shall report to the Authority any transfer of radioactive materials, in writing, starting its physical and chemical properties and any other information as determined by the Authority.
A person who sends any radioactive material to another person shall ensure that the recipient acknowledges the receipt of the dispatched radioactive material, in writing, within 30 days from the date of dispatch.
59. Investigation of shipment of radioactive material
(1) A person who sends radioactive material shall investigate any shipment or part of a shipment, where acknowledgment is received within the period specified in regulation 55 and shall immediately inform to the Authority.
(2) The shipment referred to in sub-regulation (1) shall be monitored by the sender of the radioactive material who shall prepare a report for submission to the Authority within seven days of completing the investigation.
PART X
GENERAL PROVISION
The fees specified in the Sixth Schedule are payable for the matters specified therein.
[Regulations 4, 5(2), 6, 7, 8, 9, 10, 11, 12, 13 and 14]
FORM I
[Regulation 4]
(To be completed in triplicate)
THE RADIATION PROTECTION AUTHORITY
IONISING RADIATION PROTECTION ACT
The Ionising Radiation Protection (General) Regulations, 2011
APPLICATION FOR IONISING RADIATION LICENCE
|
Shaded fields for official use only |
Application No. |
|
Licence Code |
|
Information Required |
Information Provided |
|
1. |
Name(s) of applicant |
|
2. |
(a) Nationality |
|
(b) Identity card |
|
National Registration Card No. |
|
Passport No. |
|
Company Registration No. |
|
3. |
Notification address |
|
Fax: |
|
E-mail: |
|
4. |
Purpose of application |
|
5. |
Name and qualifications of person responsible for irradiator or radiograph facility/radiation generating equipment/accelerator |
|
6. |
Contact details of person responsible for irradiator or radiography facility/radiation generating equipment/accelerator |
|
7. |
Licence previously held by the applicant under the Ionising Radiation Protection Act, 2005, or similar legislation outside Zambia.(attach certified copies) |
Licence No. |
Location |
|
8. |
Licences currently held by applicant in Zambia, if any, under the Ionising Radiation Protection Act, 2005 |
Licence No. |
Location |
|
9. |
Have you ever been convicted of an offence involving fraud or dishonesty or of any offence under the Ionising Radiation Protection Act, 2005, or any other law within or outside Zambia? |
|
Licence applied for: |
Activity |
Location |
Date of application |
Status of application (Granted, rejected or pending)* |
|
11. |
Source and Irradiator Facility/Radiation generating equipment/Accelerator |
|
Model/Type No. |
Manufacture |
Supplier |
Proposed date of commissioning |
Class |
|
Name: |
Name: |
|
Address: |
Address; |
|
12. |
Details of radioactive source |
|
Radionuclides |
Number of source |
Total activity (Bq) |
Source details |
Storage We/dry |
|
Per pencil |
Per Module |
Per rack |
Total |
Initial |
At installation |
Model No. |
Desig- nation |
|
13. |
Standards |
|
|
14. |
FACILITIES AND EQUIPMENT (In an attachment to this application, describe the irradiator/accelerator facilities as follow): |
|
|
(a) Location |
|
Provided a detailed location of the facility including the city, district, town, area, or other locality in which the facility is established. |
|
(b) Layout of facility |
|
Describe factors such as the layout of the facility and its immediate surroundings, buildings materials, alarms, shielding, engineering controls such as interlock and warning safety devices, and remote handling tools (Safety Series No. 107). Attach a detailed sketch or drawing of the facility showing the above details. Include on the drawings any penetrations or openings in the shielding materials such as conduits or ventilation ducts. Include evaluation of the ground surface and adverse environmental conditions that may cause harm to the facility (e.g. seismic history, strong winds, air crashes). Controlled and supervised areas should be clearly identified on the drawings. |
|
(c) Safety assessment |
|
Taking account of shielding, provide calculations of maximum dose rates in all areas outside the facility (specify all assumptions, e.g number of sources, activity). Provide estimates of the magnitude of expected doses to persons during normal operations. Identify the probability and magnitude of potential exposures arising from accidents or incidents. |
|
(d) Safety system |
|
(i) Describe the overall safety system which will be used to ensure the safe operation of the irradiator (e.g design features, defence in depth, layout). Further describe, in detail, the safety systems for preventing access to the irradiation room whilst the source is exposed and for warning of unsafe conditions (e.g interlocks, installed monitors). |
|
(e) Personal protection equipment |
|
Describe any personal protective equipment that will be provided. |
|
15. |
RADIATION PROTECTION AND SAFETY PROGRAMME |
|
(a) Organisational Structure |
|
<IN:LF:0.192361,FI:-0.192361> (i) Describe your organisational and management control systems, including assignment of responsibilities and clear lines of authority related to radiation safety. In particular include: staffing levels, equipment selection, other assignments of the radiation protection officer, authority of the radiation protection officer to stop unsafe operations, personnel training, maintenance of records, and how problems affecting safety are identified and corrected. |
|
(b) Workplace monitoring, area classification and individual monitoring |
|
(c) Local rules and supervision |
|
<IN:LF:0.192361,FI:-0.192361> (i) Describe your local rules and procedures regarding: investigation or authorised levels, protective measures and safety provisions, providing adequate supervision, providing workers information regarding health risks due to occupational exposure, and emergency planning instruction (BSS, 1.26-1.27) |
|
(d) Quality assurance |
|
<IN:LF:0.192361,FI:-0.192361> (i) Describe your programme for ensuring that regulatory radiation safety requirements are addressed and satisfied. |
|
(e) Transportation of radioactive material |
|
If you will be transporting new or used sources, describe your arrangements for preparation and transport of packages containing radioactive sources (IAEA Safety Standards Series No. ST-1). These procedures should address: documentation of package certification, package surveys, transfer/receipt documents, and details of shipment preparation. |
|
(f) Emergency procedures |
|
Provide your emergency procedures to address emergencies such as potential damage to the source, loss of source shielding, stuck sources or substantial accidental exposure of an individual. If other emergencies are envisaged, please provide additional appropriate emergency procedures. In all cases, the magnitude of the hazard should be elevated. Local emergency services (e.g fire, policy) may need to be provided with copies of the emergency procedures. |
|
(g) Transfer or disposal of radioactive sources system of records |
|
Describe arrangements for transfer or disposal of spent radioactive sources |
|
|
(h) System of records (BSS: 2.40, 1.44-1.49) |
|
<TS:0.75,NM,NO> (i) disposal of spent source |
|
(i) Physical security |
|
|
|
(a) Responsibilities |
|
<IN:LF:0.00486111,FI:-0.00486111> (i) Describe your arrangements to ensure that no patient is diagnostically exposed unless the exposure is prescribed by a medical doctor or dental surgeon. |
|
(b) Justification |
|
<IN:LF:0.00486111,FI:-0.00486111> (i) Describe your arrangements to ensure that medical exposures are justified by weighing the benefits they produce against the radiation detriment they might cause, taking into account the benefits and risks of alternate techniques that do not involve ionising radiation. |
|
|
(c) Optimisation of protection |
|
(i) Describe your arrangements for medical doctor or dental surgeon to ensure that the exposure of patients is the minimum necessary to achieve the diagnostic objective and take into account relevant information from previous examinations to avoid unnecessary additional examinations. |
|
(d) Calibration, clinical dosimetry and quality assurance |
|
(i) Describe your programme for calibration of the X-ray radiation beams traceable to a standards dosimetry laboratory. (BSSII.19) |
|
(e) Dose constraints |
|
Describe your policies to ensure any dose to individuals incurred knowingly while voluntarily helping (other than in their occupation) in the care support and comfort of patients undergoing medical diagnosis will be constrained to a level not exceeding that specified by the Authority. |
|
(f) Investigations of accidental medical exposure |
|
|
<TS:0.5,NM,NO>(i) Confirm that you will investigate any oral instances where: |
|
B. MEDICAL EXPOSURE – RADIOTHERAPY |
|
|
In an attachment to this application, describe the programme to control medical exposure, including: (BSS requirements related to this section may be found in Appendix II “Medical Exposure”) |
|
(a) Responsibilities |
|
(i) Describe your arrangements to assure that patient treatment will only be prescribed by medical doctor or dental surgeon. |
|
(b) Justification |
|
<IN:LF:0.192361,FI:-0.192361> (i) Describe your arrangements to ensure that the therapeutic benefits will be weighed against the radiation detriment they might cause, taking into account the benefits and risks of alternative techniques that do not involve ionising radiation. |
|
(c) Optimisation of protection |
|
<IN:LF:0.254861,FI:-0.254861> (i) Describe your arrangements to ensure that: |
|
(d) Calibration |
|
<IN:LF:0.254861,FI:-0.254861> (i) Describe your system to ensure the calibration of sources used for medical exposure is traceable to a standards dosimetry laboratory. |
|
(e) Clinical dosimetry |
|
<IN:LF:0.567361,FI:-0.317361>Describe your arrangements to ensure determination and documentation of: |
|
(f) Quality assurance for medical exposure |
|
<IN:LF:0.192361,FI:-0.192361>Described your quality assurance programme (BSSII.22) which should include: |
|
(g) Investigation of accidental medical exposure |
|
Describe the procedure to promptly investigate any of the following incidents; |
|
(h) With respect to any investigation |
|
Confirm that you will: |
|
(i) Dose constraints to comforter and visitors to patients |
|
Describe your procedures to ensure that the dose of any comforter or visitor of patients will be constrained to a level not exceeding that specified by the Authority (less than 5 mSv during the patient’s treatment) |
|
|
DECLARATION I, …………………………………….do solemnly declares as follows: (a) that the information provided in this Form is correct and true; (b) that I have never been debarred from practising any profession on the ground of professional misconduct; (c) that my name has never been removed from the Register kept in accordance with the laws of any country in which I have practised my profession; and (d) no inquiry is pending which may result in the action referred to in paragraph (b) and (c)’ and I make this solemn declaration conscientiously believing the same to be true to the best of my knowledge and belief. ………………… Signature Declared at……………..this…………………day of………….20………before me …………………………………………… Commissioner of Oaths/Notary Public ………………………………………………………………………. Applicant’s name Date ……………………………………… Applicant’s signature FOR OFFICIAL USE ONLY Received BY:………………………………..RECEIPT No:………………. Officer OFFICIAL STAMP Date Received:…………………………….. Amount Received:………………………… Serial No. of application:………………….. |
FORM II
[Regulation 4(2)]
THE RADIATION PROTECTION AUTHORITY
IONISING RADIATION PROTECTION ACT
The Ionising Radiation Protection (General) Regulations, 2011
REQUEST FOR FURTHER PARTICULARS/INFORMATION
| (1) Here insert the full names and address of applicant. (2) Here insert the reference No. of the application. (3) Signature of Secretary |
To: (1)………………………………………………………………………………………………………………………………………………………………………………………………………………. IN THE MATTER OF (2) ………………………………you are hereby requested to furnish the following information or documents in respect of your application for………………………….days. (a)…………………………………………………………………(b)…………………………………………………………………(c)…………………………………………………………………(d)………………………………………………………………… within ………………………………days. If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and shall be rejected. Dated this……………………….day of………………….20……… (3)…………………………… Secretary |
FORM III
[Regulations 5(2), 8(3) and 10(2)]
THE RADIATION PROTECTION AUTHORITY
IONISING RADIATION PROTECTION ACT
The Ionising Radiation Protection (General) Regulations, 2011
NOTICE OF REJECTION OF APPLICATION
| (1) Here insert the full names and address of applicant. (2) Here insert the reference No. of the application. (3) Here insert type of application |
To: (1)………………………………………………………………………………………………………………………………………………………………………………………………………………. IN THE MATTER OF (2) ………………………………you are hereby notified that your application for (3)……………………………..has been rejected on the following grounds: (a)…………………………………………………………………(b)…………………………………………………………………(c)…………………………………………………………………(d)………………………………………………………………… Dated this……………………….day of………………….20……… ……………………………. Secretary |
FORM IV
[Regulation 6]
THE RADIATION PROTECTION AUTHORITY
IONISING RADIATION PROTECTION ACT
The Ionising Radiation Protection (General) Regulations, 2011
Licence No……………..
IONISING RADIATION LICENCE
(Section 22 of the lonising Radiation Protection Act, No. 16 of 2005)
Holder’s name:………………………………………………………………………….
Address:…………………………………………………………………………………
The licensee is authorised to:………………………………………………………...
……………………………………………………………………………………………
……………………………………………………………………………………………
This Licence is valid from the………………day of……………………20………….to the……………day of………………………….20…………………….
The conditions of the Licence are as shown in the Annexures attached hereto.
Issued at…………………….this…………day of………………………..20…………..
…………………………………………
Secretary
ENDORSEMENT OF REGISTRATION
This Licence has this ………day of………….20………………..been entered in the Register.
……………………………………..
Chairperson
FORM V
[Regulation 7]
THE RADIATION PROTECTION AUTHORITY
IONISING RADIATION PROTECTION ACT
The Ionising Radiation Protection (General) Regulations, 2011
APPLICATION FOR VARIATION OF TERMS/CONDITIONS OF LICENCE
(Section 24 of the Ionising Radiation Protection Act, No. 16 of 2005)
|
Licence No. |
Shaded fields for official use only |
Licence Code |
|
Date and Time |
|
Information Required |
Information Provided |
|
1. |
Holder of licence |
|
2. |
Expiry date |
|
4. |
(c) Business Address |
|
(a) |
|
(b) |
|
(c) |
|
(d) |
|
(e) |
|
<TS:0.196528,NM,NO,0.375,NM,NO,0.39375,NM,NO,0.5625,NM,NO,0.590278,NM,NO,0.7875,NM,NO,0.984028,NM,NO,1.18056,NM,NO,1.37778,NM,NO,1.575,NM,NO,1.77153,NM,NO,1.96875,NM,NO> (f) |
|
5. |
Appendices |
|
Appendix No.1 |
Justifications for proposed amendments |
|
Appendix No. 2 |
Record of meeting at which amendment was adopted |
|
Receipt number |
|
Name:…………………………………………………………………………………………. |
|
Name:…………………………………………….. |
FORM VI
[Regulation 8(1)]
THE RADIATION PROTECTION AUTHORITY
IONISING RADIATION PROTECTION ACT
The Ionising Radiation Protection (General) Regulations, 2011
APPLICATION TO TRANSFER LICENCE
|
Shaded fields for official use only |
Licence Code |
|
Date/Time |
|
Information Required |
Information Provided |
|
1. |
(a) Name(s) of applicant |
|
2. |
Licence No. |
|
3. |
Notification address |
|
4. |
Details of person to whom licence is to be transferred |
|
5. |
Type of activity undertaken under licence |
|
6. |
Licence previously held by the transferee under the Ionising Radiation Protection Act, 2005, or similar legislation outside Zambia |
Licensce No. |
Location |
|
7. |
Licence currently held by the transferee in Zambia under the Ionising Radiation Protection Act, 2005 |
Licence No. |
Location |
|
10. |
Has the transferee ever been convicted of an offence involving fraud or dishonesty or of any offence under the Ionising Radiation Protection Act, 2005, or any other law within or outside Zambia? |
|
If yes, specify details:……………………………………………………………………. |
|
11. |
Has the transferee ever applied for a licence under the Ionising Radiation Protection Act, 2005? |
|
Licence applied for: |
Activity |
Location |
Date of application |
Status of application (Granted rejected or pending)* |
|
* If application was rejected, give reasons for rejection: |
|
12. |
Appendices |
|
Attach licence to be transferred |
||
|
..................................... Applicant’s signature Date ....................... FOR OFFICIAL USE ONLY Received by: .................................... Officer ............................................... OFFICIAL STAMP Date Received :.................................... Amount Received: .................................... Serial No. of application: .................................... |
FORM VII
[Regulation 8(2)]
THE RADIATION PROTECTION AUTHORITY
IONISING RADIATION PROTECTION ACT
The Ionising Radiation Protection (General) Regulations, 2011
APPROVAL OF TRANSFER OF LICENCE
(Section 25 of the Ionising Radiation Protection Act, No. 16 of 2005)
Name of holder of licence:………………………………………………………………..
Licence No:……………………………………………………………………………….
You are hereby notified that your application for the transfer of your licence has been approved. The details of the transferee are as follows:
Name:………………………………………………………………………………
Address:…………………………………………………………………………….
………………………………………………………………………………………
………………………………………………………………………………………
The terms and conditions of the transfer are as shown in the Annexures attached hereto.
Dated at…………………….this………………day of………………………….20……………
……………………………………..
Secretary
FORM VIII
[Regulation 9]
THE RADIATION PROTECTION AUTHORITY
IONISING RADIATION PROTECTION ACT
The Ionising Radiation Protection (General) Regulations, 2011
NOTICE OF INTENTION TO SURRENDER LICENCE
(Section 26(1) of the Ionising Radiation Protection Act, No. 16 of 2005)
| (1) Here insert the full names and address of licensee (2) Here insert the licence No. of the licence to be surrendered |
<BR:BT:0.0208333,0,FC:0,0,0>To the Board: (1)………………………………………………………………………………………………………………………………………………………………………………………………………………. IN THE MATTER OF (2) ………………………………I hereby notify your office that I intend to surrender my licence on…………………………day of………….20……………for the following reasons: (a)…………………………………………………………………(b)…………………………………………………………………(c)…………………………………………………………………(d)………………………………………………………………… Dated this……………………….day of………………….20……… (3) …………………………. License FOR OFFICIAL USE ONLY Received by:……………………Date Received:………………Name OFFICIAL STAMP Signature:……………………….. |
FORM IX
[Regulation 10 (1)]
THE RADIATION PROTECTION AUTHORITY
IONISING RADIATION PROTECTION ACT
The Ionising Radiation Protection (General) Regulations, 2011
APPLICATION FOR RENEWAL OF LICENCE
|
Shaded fields for official use only |
Licence Code |
|
Date/Time |
|
Information Required |
Information Provided |
|
1. |
Name(s) of applicant (State whether individual, firm, company or institution) |
|
2. |
Licence No. |
|
3. |
Notification address |
|
Tel: |
|
Fax: |
|
|
|
4. |
Type of activity authorised under licence |
|
5. |
Have you been convicted on an offence involving fraud or dishonesty or of any offence under the Ionising Radiation Protection Act, 2005, or any other law within or outside Zambia during the currency of your licence? |
|
6. |
Appendices |
|
Attach copy of current licence |
||
|
.................................................. Applicant’s signature Date ................................ FOR OFFICIAL USE ONLY Received by:................................ Officer RECEIPT No: ................................................ Date Received:.............................................. Amount Received:......................................... Serial No. of application:................................ |
FORM X
[Regulation 11(1)]
THE RADIATION PROTECTION AUTHORITY
IONISING RADIATION PROTECTION ACT
The Ionising Radiation Protection (General) Regulations, 2011
NOTICE OF INTENTION TO SUSPEND OR CANCEL LICENCE
(Section 26(3) of the Ionising Radiation Protection Act, No. 16 of 2005)
| (1) Here insert the full names and address of licensee (2) Here insert the licence No. (3) Here insert the number of days (4) Signature of Secretary |
To (1)………………………………………………………………. …………………………………………………………………………….. …………………………………………………………………………….. IN THE MATTER (2) ………………………………………you are hereby notified that the Board intend to *suspend/cancel your licence on the following grounds: (a)………………………………………………………………………… (b)…………………………………………………………………………. (c)………………………………………………………………………… (d)…………………………………………………………………………. Accordingly, you are requested to show cause why your licence should not be suspended/cancelled and to take action to remedy the breaches set out in paragraphs ………………….(above)……………within (3)……………………days of receiving this notice. Failure to remedy the said breaches shall result in the *suspension/cancellation of your licence. Dated this…………………day of………………….20……………… (4)………………………………Secretary *Delete as appropriate |
FORM XI
[Regulation 11(2)]
THE RADIATION PROTECTION AUTHORITY
IONISING RADIATION PROTECTION ACT
The Ionising Radiation Protection (General) Regulations, 2011
NOTICE OF SUSPENSION/CANCELLATION OF LICENCE
(Section 26(5) of the Ionising Radiation Protection Act, No. 16 of 2005)
| (1) Here insert the full names and address of licenses (2) Here insert the licence No. |
To (1)………………………………………………………………………………………………………………………………………………………………………………………………………………. IN THE MATTER OF (2) ………………………………you are hereby notified that your licence has been suspended for a period of …………………………../cancelled on the following grounds: (a)…………………………………………………………………(b)…………………………………………………………………(c)…………………………………………………………………(d)………………………………………………………………… Dated this……………………….day of………………….20……… (3) …………………………. Secretary |
FORM XII
[Regulation 12]
THE RADIATION PROTECTION AUTHORITY
IONISING RADIATION PROTECTION ACT
The Ionising Radiation Protection (General) Regulations, 2011
ENFORCEMENT NOTICE
(Section 27 of the Ionising Radiation Protection Act, No. 16 of 2005)
| (1) Here insert the full names and address of licensee (2) Here insert the licence No. (3) Signature of Secretary |
To (1)……………………………………………………………….. ………………………………………………………………………………………………………………………………………………. IN THE MATTER OF (2) ………………………………you are hereby notified that you are in contravention of the terms and conditions of your licence and the provisions of the Ionising Radiation Protection Act, No. 16 of 2005. Consequently, you are hereby directed to take the following action(s) before the …………..day of………………20………….. (a)…………………………………………………………………(b)…………………………………………………………………(c)…………………………………………………………………You are further directed to submit a written plan of correction of the violation indicating the dates by which you shall take the corrective action. Failure to comply with this directive may lead to the cancellation of your licence. Dated this……………………….day of………………….20……… (3) …………………………. Secretary |
FORM XIII
[Regulation 13]
THE RADIATION PROTECTION AUTHORITY
IONISING RADIATION PROTECTION ACT
The Ionising Radiation Protection (General) Regulations, 2011
NOTICE OF INTENTION OF DE-COMMISSION RADIOACTIVE DEVICE
(Section 23(7) of the Ionising Radiation Protection Act, No. 16 of 2005)
| (1) Here insert the full names and address of licensee (2) Here insert the licence No. |
To the Executive Director (1) ………………………………………………………………………………………………………………………………………………………………………………………. IN THE MATTER OF (2) ……………………………… I hereby notify your office that I intend to de-commission the following device: (a)…………………………………………………………………(b)…………………………………………………………………(c)…………………………………………………………………(d)…………………………………………………………………on the grounds set out in my application and attached to this notice. Dated this……………………….day of………………….20……… (3) …………………………. Licensee ......................................................................................................... FOR OFFICIAL USE ONLY Received by:………………......Date Received:………………… Signature:…………………………….. |
FORM XIV
[Regulation 14]
THE RADIATION PROTECTION AUTHORITY
IONISING RADIATION PROTECTION ACT
The Ionising Radiation Protection (General) Regulations, 2011
NOTICE OF APPEAL TO THE MINISTER
(Section 29 of the Ionising Radiation Protection Act, No. 16 of 2005)
IN THE MATTER OF…………………………………………………………I hereby
(Application reference and matter of appeal)
give notice of appeal against the decision of the Board on the following grounds:*
(a)……………………………………………………………………………………….
(b)……………………………………………………………………………………….
(c)……………………………………………………………………………………….
(d)……………………………………………………………………………………….
Dated this……………………….day of……………………..20……..
………………………………………
Signature of Appellant
*Attach brief if necessary
[Regulation 3]
EXEMPT CONCENTRATIONS AND QUANTITIES OF RADIO-NUCLIDES
PART I
EXEMPTION LEVELS: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIO-NUCLIDES (ROUNDED)*
|
Nuclide |
Activity Concentration |
Activity |
Nuclide |
Activity Concentration |
Activity |
|
(Bq/g) |
(Bq) |
(Bq/g) |
(Bq) |
||
|
H-3 |
1 x 106 |
1 x 109 |
Fe-52 |
1 x 101 |
1 x 106 |
|
Be-7 |
1 x 103 |
1 x 107 |
Fe-55 |
1 x 104 |
1 x 106 |
|
C-14 |
1 x 104 |
1 x 107 |
Fe-59 |
1 x 101 |
1 x 106 |
|
0-15 |
1 x 102 |
1 x 109 |
Co-55 |
1 x 101 |
1 x 106 |
|
F-18 |
1 x 101 |
1 x 106 |
Co-56 |
1 x 101 |
1 x 105 |
|
Na-22 |
1 x 101 |
1 x 106 |
Co-57 |
1 x 102 |
1 x 106 |
|
Na-24 |
1 x 101 |
1 x 105 |
Co-58 |
1 x 101 |
1 x 106 |
|
Si-31 |
1 x 103 |
1 x 106 |
Co-58m |
1 x 104 |
1 x 107 |
|
P-32 |
1 x 103 |
1 x 105 |
Co-60 |
1 x 101 |
1 x 105 |
|
P-33 |
1 x 105 |
1 x 108 |
Co-60m |
1 x 103 |
1 x 106 |
|
S-35 |
1 x 105 |
1 x 108 |
Co-61 |
1 x 102 |
1 x 106 |
|
CI-36 |
1 x 104 |
1 x 106 |
Co-62m |
1 x 101 |
1 x 105 |
|
CI-38 |
1 x 101 |
1 x 105 |
Ni-59 |
1 x 104 |
1 x 108 |
|
Ar-37 |
1 x 106 |
1 x 108 |
Ni-63 |
1 x 105 |
1 x 108 |
|
Ar-41 |
1 x 102 |
1 x 109 |
Ni-65 |
1 x 101 |
1 x 106 |
|
K-40 |
1 x 102 |
1 x 106 |
Cu-64 |
1 x 102 |
1 x 106 |
|
K-42 |
1 x 102 |
1 x 106 |
Zn-65 |
1 x 101 |
1 x 106 |
|
K-43 |
1 x 101 |
1 x 106 |
Zn-69 |
1 x 104 |
1 x 106 |
|
Ca-45 |
1 x 104 |
1 x 107 |
Zn-69m |
1 x 102 |
1 x 106 |
|
Ca-47 |
1 x 101 |
1 x 106 |
Ga-72 |
1 x 101 |
1 x 105 |
|
Sc-46 |
1 x 101 |
1 x 106 |
Ge-71 |
1 x 104 |
1 x 108 |
|
Sc-47 |
1 x 102 |
1 x 106 |
As-73 |
1 x 103 |
1 x 107 |
|
Sc-48 |
1 x 101 |
1 x 105 |
As-74 |
1 x 101 |
1 x 106 |
|
V-48 |
1 x 101 |
1 x 105 |
As-76 |
1 x 102 |
1 x 105 |
|
Cr-51 |
1 x 103 |
1 x 107 |
As-77 |
1 x 103 |
1 x 106 |
|
Mn-51 |
1 x 101 |
1 x 105 |
Se-75 |
1 x 102 |
1 x 106 |
|
Mn-52 |
1 x 101 |
1 x 105 |
Br-82 |
1 x 101 |
1 x 106 |
|
Mn-52m |
1 x 101 |
1 x 105 |
Kr-74 |
1 x 102 |
1 x 109 |
|
Mn-53 |
1 x 104 |
1 x 109 |
Kr-76 |
1 x 10 |
1 x 109 |
|
Mn-54 |
1 x 101 |
1 x 106 |
Kr-77 |
1 x 102 |
1 x 109 |
|
Mn-56 |
1 x 101 |
1 x 105 |
Kr-79 |
1 x 103 |
1 x 105 |
|
Kr-81 |
1 x 104 |
1 x 107 |
Te-97 |
1 x 103 |
1 x 108 |
|
Kr-83m |
1 x 105 |
1 x 1012 |
Te-97m |
1 x 103 |
1 x 107 |
|
Kr-85 |
1 x 105 |
1 x 104 |
Te-99 |
1 x 104 |
1 x 107 |
|
Kr-85m |
1 x 103 |
1 x 1010 |
Te-99m |
1 x 102 |
1 x 107 |
|
Kr-87 |
1 x 102 |
1 x 109 |
Ru-97 |
1 x 102 |
1 x 107 |
|
Kr-88 |
1 x 102 |
1 x 109 |
Ru-103 |
1 x 102 |
1 x 106 |
|
Rb-86 |
1 x 102 |
1 x 105 |
Ru-105 |
1 x 101 |
1 x 106 |
|
Sr-85 |
1 x 102 |
1 x 106 |
Ru-1068 |
1 x 102 |
1 x 105 |
|
Sr-85m |
1 x 102 |
1 x 107 |
Rh-103m |
1 x 104 |
1 x 108 |
|
Sr-97m |
1 x 102 |
1 x 106 |
Rh-105 |
1 x 102 |
1 x 107 |
|
Sr-89 |
1 x 102 |
1 x 106 |
Pd-103 |
1 x 103 |
1 x 108 |
|
Sr-90a |
1 x 103 |
1 x 104 |
Rh-105 |
1 x 103 |
1 x 106 |
|
Sr-91 |
1 x 102 |
1 x 105 |
Ag-105 |
1 x 102 |
1 x 106 |
|
Sr-92 |
1 x 101 |
1 x 106 |
Ag-111 |
1 x 101 |
1 x 106 |
|
Y-90 |
1 x 103 |
1 x 105 |
Cd-109 |
1 x 103 |
1 x 106 |
|
Y-91 |
1 x 103 |
1 x 106 |
Cd-115 |
1 x 104 |
1 x 106 |
|
Y-91m |
1 x 102 |
1 x 106 |
Cd-115m |
1 x 102 |
1 x 106 |
|
Y-92 |
1 x 102 |
1 x 105 |
In-11 |
1 x 103 |
1 x 106 |
|
Y-93 |
1 x 102 |
1 x 105 |
In-113m |
1 x 102 |
1 x 106 |
|
Zr-93a |
1 x 103 |
1 x 107 |
In-114m |
1 x 102 |
1 x 106 |
|
Zr-95 |
1 x 101 |
1 x 106 |
In-115m |
1 x 102 |
1 x 106 |
|
Zr-97a |
1 x 101 |
1 x 105 |
Sn-113 |
1 x 102 |
1 x 106 |
|
Nb-93m |
1 x 104 |
1 x 107 |
Sn-125 |
1 x 103 |
1 x 107 |
|
Nb-94 |
1 x 101 |
1 x 106 |
Sb-122 |
1 x 102 |
1 x 105 |
|
Nb-95 |
1 x 101 |
1 x 106 |
Sb-124 |
1 x 102 |
1 x 104 |
|
Nb-97 |
1 x 101 |
1 x 106 |
Sb-125 |
1 x 101 |
1 x 106 |
|
Nb-98 |
1 x 102 |
1 x 105 |
Te-123m |
1 x 102 |
1 x 106 |
|
Mo-90 |
1 x 101 |
1 x 106 |
Te-125m |
1 x 102 |
1 x 107 |
|
Mo-93 |
1 x 103 |
1 x 108 |
Te-127 |
1 x 103 |
1 x 107 |
|
Mo-99 |
1 x 102 |
1 x 106 |
Te-127m |
1 x 103 |
1 x 106 |
|
Mo-101 |
1 x 101 |
1 x 106 |
Te-129 |
1 x 103 |
1 x 107 |
|
Te-96 |
1 x 101 |
1 x 106 |
Te-129m |
1 x 102 |
1 x 106 |
|
Te-96m |
1 x 103 |
1 x 107 |
Ce-143 |
1 x 103 |
1 x 106 |
|
Te-131 |
1 x 102 |
1 x 105 |
Ce-144a |
1 x 102 |
1 x 105 |
|
Te-131m |
1 x 101 |
1 x 106 |
Pr-142 |
1 x 102 |
1 x 105 |
|
Te-132 |
1 x 102 |
1 x 107 |
Pr-143 |
1 x 102 |
1 x 105 |
|
Te-133 |
1 x 101 |
1 x 105 |
Nd-147 |
1 x 104 |
1 x 106 |
|
Te-133m |
1 x 101 |
1 x 105 |
Nd-149 |
1 x 102 |
1 x 106 |
|
Te-134 |
1 x 101 |
1 x 106 |
Pm-147 |
1 x 102 |
1 x 106 |
|
1-123 |
1 x 102 |
1 x 107 |
Pm-149 |
1 x 104 |
1 x 107 |
|
1-125 |
1 x 103 |
1 x 106 |
Sm-151 |
1 x 103 |
1 x 106 |
|
1-126 |
1 x 102 |
1 x 106 |
Sm-153 |
1 x 104 |
1 x 108 |
|
1-129 |
1 x 103 |
1 x 105 |
Eu-152 |
1 x 102 |
1 x 106 |
|
1-130 |
1 x 101 |
1 x 106 |
Eu-152m |
1 x 101 |
1 x 106 |
|
1-131 |
1 x 102 |
1 x 106 |
Eu-154 |
1 x 102 |
1 x 106 |
|
1-132 |
1 x 101 |
1 x 105 |
Eu-155 |
1 x 101 |
1 x 106 |
|
1-133 |
1 x 101 |
1 x 105 |
Gd-153 |
1 x 102 |
1 x 107 |
|
1-134 |
1 x 101 |
1 x 105 |
Gd-159 |
1 x 102 |
1 x 107 |
|
1-135 |
1 x 101 |
1 x 106 |
Tb-160 |
1 x 103 |
1 x 102 |
|
Xe-131m |
1 x 104 |
1 x 104 |
Co-60 |
1 x 101 |
1 x 106 |
|
Xe-133 |
1 x 103 |
1 x 104 |
Dy-165 |
1 x 103 |
1 x 106 |
|
Xe-135 |
1 x 103 |
1 x 1010 |
Dy-166 |
1 x 103 |
1 x 106 |
|
Cs-129 |
1 x 102 |
1 x 105 |
Ho-166 |
1 x 103 |
1 x 105 |
|
Cs-131 |
1 x 102 |
1 x 106 |
Er-169 |
1 x 10 |
1 x 107 |
|
Cs-132 |
1 x 101 |
1 x 105 |
Er-171 |
1 x 102 |
1 x 106 |
|
Cs-134m |
1 x 103 |
1 x 105 |
Tm-170 |
1 x 103 |
1 x 106 |
|
Cs-134 |
1 x 101 |
1 x 104 |
Tm-171 |
1 x 104 |
1 x 108 |
|
Cs-135 |
1 x 104 |
1 x 107 |
Yb-175 |
1 x 103 |
1 x 107 |
|
Cs-136 |
1 x 101 |
1 x 105 |
Lu-177 |
1 x 103 |
1 x 107 |
|
Cs-137a |
1 x 101 |
1 x 104 |
Hf-181 |
1 x 101 |
1 x 106 |
|
Cs-138 |
1 x 101 |
1 x 104 |
Ta-182 |
1 x 101 |
1 x 104 |
|
Ba-131 |
1 x 102 |
1 x 106 |
W-181 |
1 x 103 |
1 x 104 |
|
Ba-140a |
1 x 101 |
1 x 105 |
W-185 |
1 x 104 |
1 x 107 |
|
La-140 |
1 x 101 |
1 x 105 |
W-187 |
1 x 102 |
1 x 106 |
|
Ce-139 |
1 x 102 |
1 x 106 |
Re-186 |
1 x 1033 |
1 x 106 |
|
Ce-141 |
1 x 102 |
1 x 107 |
Re-188 |
1 x 102 |
1 x 105 |
|
Os-185 |
1 x 101 |
1 x 106 |
Rn-222a |
1 x 101 |
1 x 108 |
|
Os-191 |
1 x 102 |
1 x 107 |
Ra-223 a |
1 x 102 |
1 x 105 |
|
Os-191m |
1 x 103 |
1 x 107 |
Ra-224 a |
1 x 101 |
1 x 105 |
|
Os-193 |
1 x 102 |
1 x 107 |
Ra-225 |
1 x 102 |
1 x 105 |
|
Ir-190 |
1 x 101 |
1 x 106 |
Ra-226 |
1 x 101 |
1 x 104 |
|
Ir-192 |
1 x 101 |
1 x 104 |
Ra-227 a |
1 x 102 |
1 x 106 |
|
Ir-194 |
1 x 102 |
1 x 105 |
Ra-228 a |
1 x 101 |
1 x 105 |
|
Pt-191 |
1 x 102 |
1 x 106 |
Ac-228 |
1 x 101 |
1 x 106 |
|
Pt-193m |
1 x 103 |
1 x 107 |
Th-226 a |
1 x 103 |
1 x 107 |
|
Pt-197 |
1 x 103 |
1 x 106 |
Th-227 |
1 x 101 |
1 x 104 |
|
Pt-197m |
1 x 102 |
1 x 106 |
Th-228 a |
1 x 100 |
1 x 104 |
|
Au-198 |
1 x 102 |
1 x 106 |
Th-229 a |
1 x 100 |
1 x 103 |
|
Au-199 |
1 x 102 |
1 x 106 |
Th-230 |
1 x 100 |
1 x 104 |
|
Hg-197 |
1 x 102 |
1 x 107 |
Th-231 |
1 x 103 |
1 x 107 |
|
Hg-197m |
1 x 102 |
1 x 106 |
Th-nat |
1 x 100 |
1 x 107 |
|
Hg-203 |
1 x 102 |
1 x 105 |
(incl.Th-232) |
||
|
TI-200 |
1 x 101 |
1 x 106 |
Th-234 |
1 x 103 |
1 x 105 |
|
TI-201 |
1 x 102 |
1 x 106 |
Pa-230 |
1 x 101 |
1 x 106 |
|
TI-202 |
1 x 102 |
1 x 106 |
Pa-231 |
1 x 100 |
1 x 103 |
|
TI-204 |
1 x 104 |
1 x 104 |
Pa-233 |
1 x 102 |
1 x 107 |
|
Pb-203 |
1 x 102 |
1 x 106 |
U-230 a |
1 x 101 |
1 x 105 |
|
Pb-21Oa |
1 x 101 |
1 x 104 |
U-231 |
1 x 102 |
1 x 107 |
|
Pb-212a |
1 x 101 |
1 x 105 |
U-232 a |
1 x 100 |
1 x 103 |
|
Bi-206 |
1 x 101 |
1 x 105 |
U-233 |
1 x 101 |
1 x 104 |
|
Bi-207 |
1 x 101 |
1 x 106 |
U-234 |
1 x 101 |
1 x 104 |
|
Bi-21O |
1 x 103 |
1 x 106 |
U-235 a |
1 x 101 |
1 x 104 |
|
Bi-212a |
1 x 101 |
1 x 105 |
U-236 |
1 x 101 |
1 x 104 |
|
Po-203 |
1 x 101 |
1 x 106 |
U-237 |
1 x 102 |
1 x 106 |
|
Po-205 |
1 x 101 |
1 x 106 |
U-238 a |
1 x 101 |
1 x 104 |
|
Po-207 |
1 x 101 |
1 x 106 |
U-nat |
1 x 100 |
1 x 103 |
|
Po-21O |
1 x 101 |
1 x 104 |
U-239 |
1 x 102 |
1 x 106 |
|
At-211 |
1 x 103 |
1 x 107 |
U-240 |
1 x 103 |
1 x 107 |
|
Rn-220a |
1 x 104 |
1 x 107 |
U-240 |
1 x 101 |
1 x 106 |
|
Np-237 a |
1 x 100 |
1 x 103 |
Cm-244 |
1 x 101 |
1 x 104 |
|
Np-239 |
1 x 102 |
1 x 107 |
Cm-245 |
1 x 100 |
1 x 103 |
|
Np-240 |
1 x 101 |
1 x 106 |
Cm-246 |
1 x 100 |
1 x 103 |
|
Pu-234 |
1 x 102 |
1 x 107 |
Cm-247 |
1 x 100 |
1 x 104 |
|
Pu-235 |
1 x 102 |
1 x 107 |
Cm-248 |
1 x 100 |
1 x 103 |
|
Pu-236 |
1 x 101 |
1 x 104 |
Bk-249 |
1 x 103 |
1 x 106 |
|
Pu-237 |
1 x 103 |
1 x 107 |
Cf-246 |
1 x 103 |
1 x 106 |
|
Pu-238 |
1 x 100 |
1 x 104 |
Cf-248 |
1 x 101 |
1 x 104 |
|
Pu-239 |
1 x 100 |
1 x 104 |
Cf-249 |
1 x 100 |
1 x 103 |
|
Pu-240 |
1 x 100 |
1 x 103 |
Cf-250 |
1 x 101 |
1 x 104 |
|
Pu-241 |
1 x 102 |
1 x 105 |
Cf-251 |
1 x 100 |
1 x 103 |
|
Pu-242 |
1 x 100 |
1 x 104 |
Cf-252 |
1 x 101 |
1 x 104 |
|
Pu-243 |
1 x 103 |
1 x 107 |
Cf-253 |
1 x 102 |
1 x 105 |
|
Pu-244 |
1 x 100 |
1 x 104 |
Cf-254 |
1 x 100 |
1 x 103 |
|
Am-241 |
1 x 100 |
1 x 104 |
Es-253 |
1 x 102 |
1 x 105 |
|
Am-242 |
1 x 103 |
1 x 106 |
Es-254 |
1 x 101 |
1 x 104 |
|
Am-242ma |
1 x 100 |
1 x 104 |
Es-254m |
1 x 102 |
1 x 106 |
|
Am-243a |
1 x 100 |
1 x 103 |
Fm-254 |
1 x 104 |
1 x 107 |
|
Cm-242 |
1 x 102 |
1 x 105 |
Fm-255 |
1 x 103 |
1 x 106 |
|
Cm-243 |
1 x 100 |
1 x 104 |
a Parent nuclides and their progeny included in secular equilibrium are listed in the following:
|
Sr-90 |
Y-90 |
|
Zr-93 |
Nb-93m |
|
Zr-97 |
Nb-97 |
|
Ru-106 |
Rh-106 |
|
Cs-137 |
Ba-137m |
|
Ce-134 |
La-134 |
|
Ce-144 |
Pr-144 |
|
Ba-140 |
La-140 |
|
Bi-212 |
TI-208 (0.36), Po-212 (0.64) |
|
Pb-210 |
Bi-21O, Po-21O |
|
Pb-212 |
Bi-212, TI-208(0.36), Po-212 (0.64) |
|
Pb-220 |
Po-216 |
|
Rn-Z22 |
Po-218, Pb-214, Bi-214, Po-214 |
|
Ra-223 |
Rn-219, Po-215, Pb-211. Bi-211, TI-207 |
|
Ra-224 |
Rn-220, Po-216, Pb212, Bi-212, TI-208 (0.36), Po-212 (0.64) |
|
Ra-226 |
Rn-222, Po-218, Pb-214, Bi-214, Po-214. Pb-21O, Bi-21O, Po-21O |
|
Ra-226 |
Ac-228 |
|
Th-226 |
Ra-222, Rn-218, Po-214 |
|
Th-228 |
Ra-224, Rn-220, Po-216. Pb-212, Bi-212, TI-208 (0.36), Po.212 (0.64) |
|
Th-229 |
Ra-22.5, Ac-225, Fr-221, At-217, Bi-213, Po-213, Pb-209 |
|
Th-nat |
Ra-228, Ac-228, Th-228, Ra-224, Rn-220, Po-216, Po-216, Pb-212, Bi-212, TI-208 (0.36) |
|
Po-212(0.64) |
|
|
Th-234 |
Pa-234m |
|
U-230 |
Th-226, Ra-222, Rn-218, Po-214 |
|
U-232 |
Th-228, Ra-224, R-220, Rn-220, Po-216, Pb-212, Bi-212, TI-208 (0.36), Po-212 (0.64) |
|
U-235 |
Th-231 |
|
U-238 |
Th-234, Pa-234m |
|
U-nat |
Th-234, Pa-234m, U-234, Th-230, Ra-226, Ra-226, Rn-222, Po-218, Pb-214, Bi-214, |
|
Po-214, Pb-10, Bi-21O, Po-210 |
|
|
U-240 |
Np-24Om |
|
Np-237 |
Pa-233 |
|
Am-242m |
Am-242 |
|
Am-243 |
Np-239 |
*The guidance exemption levels set forth in Table I-I are subject to the following considerations:
(a) They have been derived using a conservative model based on-
(i) the criteria of para.(1-3); and
(ii) a series of limiting (bounding) use and disposal scenarios. The values of activity concentration and total activity represent the lowest values calculated in any scenario for a moderate quantity of material. (See COMMISSION OF THE EUROPEAN COMMUNITIES, Principles and Methods for Establishing Concentration and Quantities (Exemption Values) below which Reporting Is Not Required in the European Directive, Radiation Protection 65, Doc. XI-028/93, CEC, Brussels (1993)
(b) the application of exemption to natural radio-nuclides, where these are not excluded, is limited to the incorporation of naturally occurring radio-nuclides into consumer products or their use as a radioactive source (e.g. Ra-226, Po-21O) or for their elemental properties (e.g. thorium, uranium);
(c) in the case of more than one radio-nuclide, the appropriate sum of the ratios of the activity or activity concentration of each radio-nuclide and the corresponding exempt activity or activity concentration shall be taken into account;
(d) unless the exposure is excluded, exemption for bulk amounts of materials with activity concentration lower than the guidance exemption levels of Table I-I r. may nevertheless, require further consideration by the Authority.
PART II
GUIDELINES FOR ACTION LEVELS IN CHRONIC EXPOSURE SITUATIONS
Radon in Dwellings
Optimised action levels relating to chronic exposure involving radon in dwellings should, in most situations. fall within a yearly average concentration of 200 to 600 Bq.m-3 of 222Rn in air.
Radon in Workplaces
The action level for remedial action relating to chronic exposure situations involving radon in workplaces is a yearly average concentration of 1000 Bq of 222Rn per cubic metre of air 47.
Note:
Although the concept of action levels for chronic exposure situations is of more general application, so far international consensus on numerical values only exists in respect of radon.
[Regulations 3, 16(1), 19 and 23]
DOSE LIMITS
1.0. Dose Limits for Exposure Incurred from Practices
The occupational exposure of any employee shall be so controlled that the following limit are not exceeding:
(a) an effective dose of 20 mSv per year averaged over five consecutive years;
(b) an effective dose of 50 mSv in any single year;
(c) an equivalent dose to the lens of the eye of 150 mSv in a year; and
(d) 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 who are required to use sources in the course of their studies, the occupational exposure shall be so controlled that the following limits shall be not exceed:
(a) an effective dose of 6 mSv in a year;
(b) an equivalent dose to the lens of the eye of 50 mSv in a year; and
(c) an equivalent dose to the extremities or the skin of 150 mSv in a year.
2.0. Special Circumstances
Where, due to special circumstances, the Authority changes the dose limit-
(a) the dose averaging period referred to in paragraph 1 may be up to ten consecutive years as specified by the Authority, and the effective dose for any employee shall not exceed 20 mSv per year averaged over this period and shall not exceed 50 mSv in any single year.
(b) the circumstances shall be reviewed when the dose accumulated by any worker since the start of the extended averaging period reaches 100 mSv; or
(c) the temporary change in dose limitation shall be as specified by the Authority, but shall not exceed 50 mSv in any year and the period of these change shall not exceed five years.
3.0. 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:
(a) an effective dose of 1 mSv in a year;
(b) in special circumstances, an effective dose of up to 5 mSv in a single year provided in that the average dose over five consecutive years does not exceed 1 mSv per year;
(c) an equivalent dose to the lens of the eye of 15 mSv in a year; an
(d) an equivalent dose in the skin of 50 mSv in a year.
The start of the averaging period shall be coincident with the first day of the relevant annual period starting from the date of entry into force of the Regulations, with no restorative averaging.
4.0. Internal Exposure
Internal exposure caused by inhalation or ingestion of radioactive substances shall be estimated in accordance with methodologies, parameter and values contained in the International Basic Safety Standards for the protection against Ionising Radiation and for the Safety of Radiation Sources, IAEA Safety Series No. 115(1), Schedule II.
5.0. Dose Limitation for Comforters and Visions
The dose limits set out in this Schedule shall not apply to comforters or visitors of patients. However, the dose of any such comforter or visitor shall be constrained so that it is unlikely that the dose will exceed 5 mSv during the period of the diagnostic examination or treatment. The dose to children visiting patients who have ingested or have been injected radioactive materials shall be similarly constrained to less than 1 mSv.
[Regulations 17, 31, 35, 36 and 37]
GUIDANCE LEVELS OF DOSE, DOSE RATE AND ACTIVITY FOR MEDICAL EXPOSURE
1.0. GUIDANCE LEVELS FOR DIAGNOSTIC RADIOLOGICAL PROCEDURE
1.1. Guidance levels of dose for diagnostic radiography for a typical adult patient
|
Examination |
Entrance surface dose per radiograph * (mGy) |
|
Lumbar spine |
AP10 |
|
Abdomen, intravenous urography and cholecystography |
AP10 |
|
Pelvis |
AP10 |
|
Hip joint |
AP10 |
|
Chest |
PA0.4 |
|
Thoracic spine |
AP7 |
|
Dental |
Periapical 7 |
|
Skull |
PA5 |
Notes: PA: Posterior-anterior projection; LAT: Lateral projection; LSJ: Lumbo-sacral-joint projection; AP: Anterior-posterior projection.
*In air with back scatter. These values are for conventional film-screen combination in the relative speed of 200. For high speed film-screen combination (400-600), the values should be reduced by a factor of 2 to 3.
1.2. Dose guidance levels for computed tomography for a typical adult patient
| Examination Multiple scam average dosea (mGy) |
| Head 50 |
| Lumbar spine35 |
| Abdomen25 |
a Derived from measurement on the axis of rotation in water equivalent phantoms, 15cm in length and 16 cm (head) and 30 cm (Lumbar spine and abdomen) in diameter.
1.3. Dose guidance levels for mammography for a typical adult patient
Average glandular dose per cranio-caudal projection
1 mGy (without grid)
3 mGy (with grid)
a Determined in a 4.5 cm compressed breast consisting of 50% glandular and 50% adipose tissue, for film screen systems and dedicated Mo-target Mo-filter mammography units.
1.4. Dose rate guidance levels for fluoroscopy for a typical adult patient
|
Mode of operation |
Entrance surface dose ratea (mGy/min) |
|
Normal |
25 |
|
High level b |
100 |
a In air with backscatter
b For fluoroscope that have an optional “high level” operational mode, such as those frequently used in interventional radiology.
2.0. GUIDANCE LEVELS FOR DIAGNOSTIC PROCEDURES IN NUCLEAR MEDICINE
2.1. Guidance levels of activity for procedures in nuclear medicines for a typical adult patient
|
Test |
Radionuclide |
Chemical form a |
Maximum usual activity per test b (MBq) |
|
Bone |
|
Phosphonate and phosphate compounds |
600 |
|
Brain |
|
|
|
|
Cerebral blood Flow |
133Xe |
In isotonic sodium chloride solution |
400 |
|
Lacrimal |
|
|
|
|
Lung |
|
|
|
|
Liver and spleen |
|
|
|
|
Cardiovascular |
|
|
|
|
Stomach gastrointestinal tract |
|
|
|
|
Kidney, urinary system and adrenals |
|
|
|
|
Miscellaneous |
67Ga |
|
|
a In some countries some of the compounds are considered obsolete
b In some countries the typical values are lower than those indicated in the table.
3.0. GUIDANCE LEVEL OF ACTIVITY FOR DISCHARGE FROM HOSPITAL
3.1. Guidance levels for maximum activity for patients in therapy on discharge from hospital
| Radionuclide | Activity (MBq) |
| Iodine-131 | 1100 In some countries a level of 400 MBq is used as an example of good practice.a |
[Regulation 33]
MEDICAL EXPOSURE – DESIGN AND OPERATIONAL REQUIREMENTS
A. Design of sources and equipment
<IN:LF:0.28125,FI:-0.28125>1.0. The requirement for the safety of sources shall apply to sources used in medical exposure where relevant and, in particular, equipment used in medical exposure shall be so designed that-
(a) failure of equipment or components can be promptly detected so that any accidental exposure of patients can be avoided or minimised; and
(b) the risk of delivering accidental exposure to patients by human error is minimised.
<IN:LF:0.28125,FI:-0.28125>2.0. A licensee shall, in co-operation with suppliers of radiation generators, sources and accessories-
(a) ensure that the exposures from radiation generators, sources and accessories are as low as reasonably achievable so as to facilitate the keeping of medical diagnostic information and therapeutic results;
(b) ensure that equipment containing sources for medical exposure conforms to applicable international and national standards;
(c) ensure that performance specifications and operating and maintenance instructions, including radiation safety aspects, are provided in a language understandable to the user;
(d) identify and take all reasonable measures to prevent failure and human errors that could result in accidental medical exposures, including the establishment of adequate procedures for calibration, quality assurance and operation of diagnostic and therapeutic equipment and the selection, training and periodic re-training of suitably qualified personnel;
(e) ensure that any radiation emitting equipment is provided with radiation beam control mechanisms, including safety interlocks and clear and fail-safe “on-of” indicators;
(f) ensure that devices are provided to limit the exposure to the area being examined or treated and keep exposure rates outside that area due to radiation leakage or scattering as low as reasonably achievable; and
(g) ensure that, where 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.
B. Operational aspects
1.0. In diagnostic exposure, a licensee shall ensure that-
(a) the medical personnel who prescribe or conduct radiological diagnostic examinations-
(i) ensure that appropriate equipment is used;
(ii) ensure that the exposure of patients is the minimum necessary to achieve the required diagnostic objective, taking into account norms of acceptable image quality established by appropriate professional bodies and relevant levels for medical exposure;
(iii) take into account relevant information from previous examinations in order to avoid unnecessary additional examinations;
(iv) avoid radiological examination causing exposure of the abdomen or pelvis of women who are pregnant or are likely to be pregnant unless there are strong clinical reasons for such examinations;
(v) plan any diagnostic examination of the abdomen or pelvis of women of reproductive capacity so as to deliver the minimum dose to any embryo or foetus that might be present;
(vi) ensure that portable and mobile radiological equipment is used only for examinations where it is impractical or not medically acceptable to transfer patients to a stationary radiological installation and only after attention has been given to the radiation protection measures required in its use; and
(vii) ensure, whenever feasible, that shielding of radio-sensitive organs such as the gonads, lens of the eye, breast and thyroid is provided as appropriate; and
(b) the medical personnel, 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 (such as the number of films or computed tomography slices) or the time per examination (fluoroscopic time);
(ii) the type of image receptor (high versus low speed screens);
(iii) the use of antiscatter grids;
(iv) proper collimation of the primary X-ray beam to minimise the volume of patient tissue being irradiated and to improve image quality;
(v) appropriate values of operational parameters (tube generating potential, current and time or their product);
(vi) appropriate image storage techniques in dynamic imaging (number or images per second); and
(vii) adequate image processing factors (developer temperature and image reconstruction algorithms).
C. Nuclear medicine
A. licensee shall ensure that-
(a) the medical personnel who prescribe or conduct diagnostic applications of radio nuclides-
(i) 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;
(ii) take into account relevant information from previous examinations in order to avoid unnecessary additional examinations;
(iii) avoid administration of radionuclides for diagnostic procedures to pregnant women unless there are strong clinical indications;
(iv) recommend discontinuation of nursing for mothers in lactation, until the radiopharmaceutical is no longer secreted in an amount estimated to give an unacceptable effective dose to the nursing; and
(v) ensure that administration of radionuclides to children for diagnostic procedures is carried out only if there is strong clinical indication, and the activity of the radionuclides administered is reduced according to body weight, body surface area or other appropriate criteria; and
(b) the medical personnel, the technologist or the other imaging staff, as appropriate, endeavour to achieve the minimum patient exposed consistent with accepted image quality by the-
(i) appropriate selection of the available radiopharmaceutical and its activity, noting the special requirements of 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 where applicable; and
(ii) appropriate image acquisition and processing.
D. Therapeutic exposure
A licensee shall ensure that the medical personnel who prescribe or conduct radiotherapy procedures with radiation sources or with radionuclides –
(a) ensure that the prescribed absorbed dose is delivered to the planning target volume or organ;
(b) 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;
(c) avoid radiotherapeutic procedures causing exposure of the abdomen or pelvis of women who are pregnant or likely to be pregnant unless there are strong clinical indications;
(d) avoid administration of radionuclides for therapeutic procedures to women who are pregnant or are likely to be pregnant or who are nursing, unless there are strong clinical indications;
(e) plan any therapeutic procedure for pregnant women so as to deliver the minimum dose to an embryo or foetus; and
(f) inform the patient of the possible risks.
[Regulation 60]
[Sixth Sch subs by reg 2 of SI 58 of 2014.]
PRESCRIBED FEES
|
Item |
Fee Units | ||
| 01 Medical Application | |||
| (a) | use or possession of x-ray machine by a health facility per device: | ||
| (i) public | 7,500 | ||
| (ii) private | 15,000 | ||
| (b) | use or possession of computed tomography scanner (public or private), per device | 35,000 | |
| (c) | importation or exportation of medical diagnostic x-ray machine, per device | 12 ,500 | |
| (d) | importation or exportation of computed tomography scanner per device | 25,500 | |
| (e) | use or possession of radiotherapy (teletherapy or brachytherapy) device or biological irradiating device, per device | 17,500 | |
| (f) | importation of radiotherapy (teletherapy or brachytherapy) device or biological irradiating device, per device | 15,000 | |
| (g) | use or possession of unsealed sources for diagnostic or therapeutic purposes in nuclear medicine | 15,000 | |
| 02 Industrial irradiating facility and nuclear facility | |||
| (a) | use or possession of industrial irradiation and nuclear facility, per source | 25,000 | |
| (b) | use or possession of fixed or portable nuclear gauges for level measurement, density measurement, thickness control, moisture measurement and control and in stream analysis of slurries, per source | 12,500 | |
| (c) | use or possession of xray and radioactive materials for nondestructive testing, per source | 25,000 | |
| (d) | transfer of a licence | 12,500 | |
| (e) | transportation of category 1 to III radioactive material within Zambia or transit through Zambia, per source or per trip | 12,500 | |
| (f) | transportation of nuclear material through and within the country, per source | 12,500 | |
| (g) | importation or exportation of fixed or portable nuclear gauges for level detection, density measurement, thickness control, moisture measurement and control and in stream analysis of slurries, per source | 10,000 | |
| (h) | use or possession of xray equipment used for level detection and sorting of materials, per source | 25,000 | |
| (i) | importation or exportation of linear accelerator or radioactive devices for nondestructive testing and cargo or container inspection, per source | 25,000 | |
| (j) | importation or exportation of industrial radiation sources, per source | 10,000 | |
| (k) | importation or exportation of xray fluorescence, xray diffraction and neutron activation analysis equipment, per source | 10. 000 | |
| (l) | use or possession of linear accelerators or devices with radioactive sources for cargo and for container inspection, per source | 25,000 | |
| 03 Teaching and Research purposes | |||
| (a) | use or possession of xray equipment by training institution, per source | 1,000 | |
| (b) | use or possession of xray equipment fluorescence, xray diffraction arid neutron activation analysis by training institution, per source | 1,000 | |
| (c) | use or possession of reaching or educational radiation sources | 2,500 | |
| (d) | use or possession of unsealed sources used for research, teaching and nuclear medicine | 2,500 | |
| (e) | importation or exportation of unsealed sources used for research, teaching and nuclear medicine | 2,500 | |
| (f) | importation or exportation of teaching or educational radiation sources other than unsealed radiation sources | 2,500 | |
| 04 Prospecting, Mining and Processing Radioactive Ores | |||
| (a) | Prospecting of radioactive ores | 250,000 | |
| (b) | Mining of radioactive ores | 250,000 | |
| (c) | Processing of radioactive ores | 500,000 | |
| (d) | Importation or exportation of samples containing radioactive ores | 40,000 | |
| (e) | Transportation of concentrated radioactive ores, per container | 40,000 | |
| 05 Assessment or Inspection | |||
| (a) | Assessment or inspection of diagnostic xray unit, except mammography and computed tomography scanner, per unit | 2,500 | |
| (b) | Assessment or inspection of a duo diagnostic domestic machine that uses both conventional and fluoroscopy, per unit | 5,000 | |
| (c) | Assessment or inspection of computed tomography scanner | 5,000 | |
| (d) | Assessment or inspection of radiotherapy devices and nuclear medicine, per unit | 5,000 | |
| (e) | Assessment or inspection of baggage screening and mineral sorting radiation devices, per unit | 5,000 | |
| (f) | Assessment or inspection of xray or gamma units for non-destructive testing (NDT) per device | 7,500 | |
| (g) | Assessment or inspection of linear accelerators or devices with radioactive sources for cargo or container inspection, per device | 7,500 | |
| (h) | Assessment or inspection of industrial irradiator, per device | 12,500 | |
| (i) | Assessment or inspection of biological irradiator, per device | 5,000 | |
| (j) | Assessment or inspection of fixed or portable nuclear gauges, per device | 5,000 | |
| (k) | Assessment or inspection of teaching or educational radiation sources, per device | 1,000 | |
| (l) | Assessment or inspection of nuclear analytical facility | 2,500 | |
| (m) | Assessment of radon levels in underground mines, per mine | 125,000 | |
| (n) | Assessment of radon levels in dwelling places, per room | 20,000 | |
| (o) | Assessment of radon levels at workplaces (per room) | 20,000 | |
| (p) | Assessment or inspection of industrial scrap metal yard | 50,000 | |
| 06 Personnel Dosimetry Service | |||
| (a) | Individual monitoring per year | 1,800 | |
| (b) | Purchase or replacement of a lost dosimeter | 5,000 | |
| 07 Environmental Monitoring for Radioactivity | |||
| (a) | Air samples | 2,000 | |
| (b) | Soil samples, building and construction material, per kg | 2,000 | |
| (c) | Water samples | 2.000 | |
| (d) | Food stuff, per kg | 2,000 | |
| 08 Fees for other related activities | |||
| (a) | Provision of structural design and layout of diagnostic xray facilities | 1,000 | |
| (b) | Review of radiation shielding (external beam radiation) | 10, 000 | |
| (c) | Consultancy services: | ||
| (i) public institution | 20,000 | ||
| (ii) private institution | 30.000 |
{/mprestriction}