CHAPTER - 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.]

Arrangement of Paragraphs

   Paragraph

   1.   Title

   2.   Fees and charges

      SCHEDULE

[Regulations by the Minister]

SI 86 of 1992,

SI 46 of 1996.

1.   Title

These Regulations may be cited as the Ionizing Radiation (Fees) Regulations.

2.   Fees and charges

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.]

SCHEDULE

[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]

Arrangement of Regulations

PART I
PRELIMINARY

   Regulation

   1.   Title

   2.   Interpretation

   3.   Competent Authority

PART II
LIMITS OF EXPOSURE TO RADIATION

   4.   Dose equivalent limits for workers

   5.   Dose limits of women of reproductive capacity

   6.   Limits of radionuclides

   7.   Planned special exposures

   8.   Personnel Monitoring

   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

   14.   Classification of areas

   15.   Warning signs for restricted and controlled areas

PART IV
LICENSING

   16.   Application for licence

   17.   Type of licence

   18.   Permissible levels of radionuclides

PART V
TRANSPORT AND STORAGE OF RADIOACTIVE MATERIALS

   19.   IAEA Transport Regulations

   20.   Approval of transport

   21.   Storage in transit

   22.   Transfer of sources

   23.   Acknowledgement receipt of dispatch of radioactive material

   24.   Investigation of shipment of radioactive material

PART VI
RADIATION SAFETY OFFICER

   25.   Radiation safety officer

   26.   Duties of radiation safety officer

PART VII
RADIOATIVE RELEASES TO THE ENVIRONMENT

   27.   Authority

   28.   Monitoring

PART VIII
EXPOSURE FROM CONSUMER PRODUCTS

   29.   Consumer products

PART IX
CESSATION AND SUSPENSION OF OPERATION, DECOMMISSIONING AND ABANDONMENT OF INSTALLATION

   30.   Authority from Board

   31.   Approval to prevail

   32.   Exemption

   33.   Secrecy

   34.   Offences and penalty

      FIRST SCHEDULE

      SECOND SCHEDULE

      THIRD SCHEDULE

      FOURTH SCHEDULE

[Regulations by the Minister]

SI 171 of 1992

PART I
PRELIMINARY

1.   Title

These Regulations may be cited as the Ionizing Radiation Protection Regulations.

2.   Interpretation

   (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.

3.   Competent Authority

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.

6.   Limits of radionuclides

   (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.

7.   Planned special exposures

   (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.

8.   Personnel Monitoring

   (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.

14.   Classification of areas

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

16.   Application for licence

   (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.

17.   Type of licence

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")."

20.   Approval of transport

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.

21.   Storage in transit

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.

22.   Transfer of sources

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

25.   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

27.   Authority

   (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.

28.   Monitoring

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

29.   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

30.   Authority from Board

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.

31.   Approval to prevail

Any approval or instruction issued under Regulation 29 shall prevail over a licence.

32.   Exemption

The Board may exempt any person from the provisions of any of these Regulations on the recommendations of the Radioisotope advisory Committee.

33.   Secrecy

No person shall disclose any information unless authorised to do so under these Regulations.

34.   Offences and penalty

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.

FIRST SCHEDULE

[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)

50 mSv per year

SECOND SCHEDULE

[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

THIRD SCHEDULE

[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

FOURTH SCHEDULE

[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 BoardFor official use only
Ministry of HealthLicence No.
P.O. Box 30205Reg. No.
LusakaReceipt 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 MassChemical/ActivityName of Model
No. of Rad.PhysicalManufacturer/
MaterialFormNo. 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

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.

Chairman, Radiation Secretary, Radiation

Protection Board Protection Board

Conditions of Licence:

1.   This licence is valid from ........................................ to

2.   Specific area or part to be modified For modification of the devices only registered installation service or maintenance personnel may make such modifications.

Date .............................................................. Signature

REPUBLIC OF ZAMBIA

Form RPS/A/6

For official use only

Reg. No

Licence

Receipt No.

Radiation Protection Board

Ministry of Health.

P.O. Box 30205

Lusaka

IONIZING RADIATION ACT, 1972

(Cap. 311)

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 BoardProtection 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

   1.   Title

   2.   Commencement of Act No. 16 of 2005

SI 119 of 2006.

1.   Title

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

SI 98 of 2011.

PART I
PRELIMINARY

Regulation

   1.   Title

   2.   Interpretation

   3.   Exemption

PART II
LICENSING

   4.   Application for licence

   5.   Rejection of application

   6.   Issue of licence

   7.   Variation of terms and conditions of licence

   8.   Transfer of licence

   9.   Surrender of licence

   10.   Application for renewal of licence

   11.   Suspension or cancellation of licence

   12.   Enforcement notice

   13.   De-commissioning of radioactive device

   14.   Appeal

PART III
RADIATION PROTECTION

   15.   Justification of practice

   16.   Dose limit

   17.   Guidance levels for medical exposure

   18.   Optimisation of protection and safety

   19.   Dose constraints

   20.   Annual limit on intake

PART IV
OCCUPATIONAL EXPOSURE

   21.   General responsibilities

   22.   Conditions of service

   23.   Classification of areas

   24.   Local rules and supervision

   25.   Personal protective equipment

   26.   Exposure assessment

   27.   Monitoring of workplace

   28.   Health surveillance

   29.   Records of employee

   30.   Special circumstances

PART V
MEDICAL EXPOSURE

   31.   General responsibilities

   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

   36.   Guidance levels

   37.   Maximum activity for patients in therapy on discharge from hospital

   38.   Investigation of accidental medical exposure

   39.   Medical dosimetry record

PART VI
PUBLIC EXPOSURE

   40.   General responsibilities

   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

   46.   General responsibilities

   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

   54.   Definition

   55.   Transportation of radioactive materials

   56.   Storage in transit

   57.   Transfer of sources

   58.   Receipt of dispatch

   59.   Investigation of shipment of radioactive material

PART X
GENERAL PROVISION

   60.   Fees

      FIRST SCHEDULE

      SECOND SCHEDULE

      THIRD SCHEDULE

      FOURTH SCHEDULE

      FIFTH SCHEDULE

      SIXTH SCHEDULE

PART I
PRELIMINARY

1.   Title

These Regulations may be cited as the Ionising Radiation Protection (General) Regulations, 2011.

2.   Interpretation

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’

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