Radiation Protection: Subsidiary Legislation (Botswana)

Radiation Protection: Subsidiary Legislation

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PART XV
General Provisions (regs 100-102)

100. Forms

The forms to be used in the issuance of licences, permits and certificates under section 23 of the Act shall be as set out in the Eighth Schedule.

101. Fees

The fees to be charged for the issuance of licences under section 23 of the Act, permits or certificates and charges for the services rendered by the inspectorate shall be as set out in the Ninth Schedule.

102. Penalties

(1) Any person who contravenes regulations 7, 15, 17, 19 , 20, 21, 23, 24, 25, 26, 27, 28, 29, 30, 33, 34, 35, 36, 37, 57, 60, 63, 71, 74, 86, 91, 92, 97, or 98 or who fails to comply with any order, requirement or condition lawfully imposed on him or her by virtue of any such regulation, shall be guilty of an offence and liable to a fine not exceeding P25,000, or to imprisonment for a term not exceeding six months, or to both.

(2) Any person who contravenes regulations 38, 47, 48, 49, 50, 51, 52, 53, 54, 61, 71, 72, 73, 79, 93, 95 or 97 shall be guilty of an offence and liable to a fine not exceeding P100,000, or to imprisonment for a term not exceeding two years, or to both.

(3) Any person who contravenes regulations 39, 40, 41, 42, 43, 44, 45, 46, 65, 66, 67, 68, or 69 shall be guilty of an offence and liable to a fine not exceeding P500,000, or to imprisonment for a term not exceeding 10 years, or to both.

(4) Any person who deliberately exposes himself or herself or his or her monitoring equipment shall be guilty of an offence.

(5) Any person who is guilty of an offence under these Regulations for which no penalty is otherwise provided shall be liable to a fine not exceeding P25,000, or to imprisonment for a term not exceeding six months, or to both.

FIRST SCHEDULE
EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES

(regs 13 (1)(a) and (b), (3)(a) and 16)

SECOND SCHEDULE
DOSE LIMITS FOR EXPOSURES INCURRED FROM PRACTICES

(regs 18(1), 20(1))

1. OCCUPATIONAL DOSE LIMITS

(a) The occupational exposure of any worker shall be so controlled that the following limits are not exceeded-

(i) an effective dose of 20 mSv per year averaged over five consecutive years;

(ii) an effective dose of 50 mSv in any single year;

(iii) an equivalent dose to the lens of the eye 150 mSv in a year; and

(iv) an equivalent dose to the extremities (hands and feet) or the skin of 50mSv in a year.

(b) For apprentices of 16 to 18 years of age who are training for employment involving exposure to radiation and for students of age16 to18 who are required to use sources in the course of their studies, the occupational exposure shall be so controlled that the following limits be not exceeded-

(i) an effective dose of 6 mSv in a year;

(ii) an equivalent dose to the lens of the eye 50 mSv in a year; and

(iii) an equivalent dose to the extremities or the skin of 150 mSv in a year.

2. SPECIAL CIRCUMSTANCES

When, in special circumstances, a temporary change in the dose limitation requirements is approved pursuant to regulation 40-

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

(b) the temporary change in dose limitation shall be as specified by the Regulatory Authority, but shall not exceed 50 mSv in any year and the period of the temporary change shall not exceed five years.

3. 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 I mSv in a year;

(b) in special circumstances, an effective dose of up to 5 mSv in a single year provided that the average dose over five consecutive years does not exceed I mSv per year;

(d) an equivalent dose to the skin of 50 mSv in a year.

_________________________

1 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 retroactive averaging.

INTERNAL EXPOSURE
Internal exposure caused by inhalation or ingestion of radioactive substances shall be estimated in accordance with the methodologies, parameters and values contained in the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources, IAEA Safety Series No.15 [1], Schedule II.

DOSE LIMITATION FOR COMFORTERS AND VISITORS OF PATIENTS
The dose limits set out in this part shall not apply to comforters or visitors of patients. However the dose of any such comforter or visitor shall be 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 I mSv.

THIRD SCHEDULE
MEDICAL EXPOSURE DESIGN AND OPERATIONAL REQUIREMENTS

(reg 41)

1. Design of sources and equipment

(a) The requirements for the safety of sources specified in regulations 56 to 59 of these regulations shall apply to sources used in medical exposure where relevant and, in particular, equipment used in medical exposure shall be so designed that-

(i) failure of equipment or components can be promptly detected so that any unplanned exposure of patients can be avoided or minimised; and

(ii) the risk of delivering unplanned exposure to patients by human error is minimised.

(b) Licensees, in cooperation with suppliers where relevant or appropriate, shall-

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

(ii) ensure that equipment containing sources for medical exposure conforms to applicable international and national standards;

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

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

(v) ensure that any radiation emitting equipment is provided with radiation beam control mechanisms, including safety interlocks and clear and fail-safe "on-off " indicators;

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

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

2. Operational aspects

Diagnostic exposure

Licensees shall make sure that-

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

(i) ensure that the appropriate equipment is used,

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

(iii) take into account relevant information from previous examinations in order to avoid unnecessary additional examinations,

(iv) avoid radiological examinations causing exposure of the abdomen or pelvis of women who are pregnant or likely to be pregnant unless there are strong clinical reasons for such examinations,

(v) plan any diagnostic examination of the abdomen or pelvis of women of reproductive capacity so as to deliver the minimum dose to any embryo or foetus that might be present,

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

(vii) ensure that, whenever feasible, shielding of radiosensitive organs such as the gonads, lens of the eye, breast and thyroid is provided as appropriate;

(b) the medical practitioner, the technologist or other imaging staff select the following parameters, as relevant, such that their combination produce the minimum patient exposure consistent with acceptable image quality and the clinical purpose of the examination, paying particular attention to this selection for pediatrics radiology and interventional radiology-

(i) the area to be examined, the number and size of views per examination (e.g. number of films or computed tomography slices) or the time per examination (e.g. fluoroscopic time),

(ii) the type of image receptor (e.g. high versus low speed screens),

(iii) the use of anti-scatter 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 (e.g. tube generating potential, current and time or their product),

(vi) appropriate image storage techniques in dynamic imaging (e.g. number of images per second); and

(vii) adequate image processing factors (e.g. developer temperature and image reconstruction algorithms).

2. Nuclear medicine

Licensees shall make sure that-

(a) the medical practitioners 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 radio nuclides for diagnostic procedures to women pregnant or likely to be pregnant unless there are strong clinical indications,

(iv) for mothers in lactation, recommend discontinuation of nursing until the radio pharmaceutical is no longer secreted in an amount estimated to give an unacceptable effective dose to the nursling, and

(v) ensure that administration of radionuclides to children for diagnostic procedures is carried out only if there is a strong clinical indication, and the activity of the radionuclides administered is reduced according to body weight, body surface area or other appropriate criteria;

(b) the medical practitioner, the technologist or other imaging staff, as appropriate, shall endeavor to achieve the minimum patient exposure consistent with acceptable image quality by-

(i) appropriate selection of the best available radio pharmaceutical and its activity, noting the special requirements for children and for patients with impairment of organ function,

(ii) use of methods for blocking the uptake in organs not under study and for accelerated excretion when applicable, and

(iii) appropriate image acquisition and processing.

3. Therapeutic exposure

Licensees shall make sure that the medical practitioners 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 radio therapeutic procedures causing exposure of the abdomen or pelvis of women who are pregnant or likely to be pregnant unless there are strong clinical indications;

(d) avoid administration of radionuclides for therapeutic procedures to women who are pregnant or likely to be pregnant or who are nursing, unless there are strong clinical indications;

(e) plan any therapeutic procedure for pregnant women so as to deliver the minimum dose to any embryo or foetus; and

(f) inform the patient of possible risks.

FOURTH SCHEDULE
GUIDANCE LEVELS OF DOSE, DOSE RATE AND ACTIVITY FOR MEDICAL EXPOSURE

(regs 29(2)(a), 30(3), 38(3), 39(e), 43(2), 44(2), and 45(1))

GUIDANCE LEVELS FOR
DIAGNOSTIC PROCEDURES IN NUCLEAR MEDICINE

FIFTH SCHEDULE
DOSE LEVELS ATWHICH INTERVENTION IS EXPECTED TO BE UNDERTAKEN UNDER ANY CIRCUMSTANCES

(reg 20(2))

SIXTH SCHEDULE
RADIOACTIVE WASTE CLASSIFICATION

(regs 59, 76(1) and (3), 77(3), 83(4), 86(a)(i) and 89(2)(c))

Class

Description

Cleared material/waste

Materials containing levels of radionuclides at concentrations less than the clearance levels established by the Radiation
Protection Inspectorate

Low level (short-lived)/
Decay waste

Low level radioactive waste containing short-lived radionuclides only (e.g. with half-lives less than 10 days) that willdecay to clearance levels within three years after the time of its generation

Low and intermediate level short-lived waste (LILW-SL)

Waste which will not decay to clearance levels within three years and contains beta/gamma emitting radionuclides with half-lives less than 30 years and/or alpha emitting radionuclideswith an activity less than 400Bqlg and a total activity less than 4000 Bq in each waste package

Low and intermediate level long-lived waste (LILW-LL)

Radioactive waste containing radionuclides with concentratons above those for LBLW-SL, but which does not generate heat at above 2 kW/m3 of waste.

SEVENTH SCHEDULE
REQUIREMENTS AND CONTROLS FOR TRANSPORTATION OF RADIOACTIVE MATERIAL

INCLUDING
LIST OF UNITED NATIONS NUMBERS, PROPER SHIPPING NAMES AND DESCRIPTION AND SUBSIDIARY RISKS

(regs 84(4), (8), 85(6), 88(2)(a) and (d), 3(a), (b), (5) and (8))

FIG. 1. Basic trefoil symbol with proportions based on a central circle of radius X.
The minimum allowable size of X shall be 4 mm.

FIG. 2. Category I-WHITE label: The background colour of the label shall be white, the colour of the trefoil and the printing shall be black, and the colour of the category bar shall be red.

FIG. 3. Category II-YELLOW label. The background colour of the upper half of the label shall be yellow and the lower half white, the colour of the trefoil and the printing shall be black, and the colour of the category bars shall be red.

FIG. 4. Category III-YELLOW label. The background colour of the upper half of the label shall be yellow and the lower half white, the colour of the trefoil and the printing shall be black, and the colour of category bars shall be red.

FIG. 5. Critically safety index label. The background colours of the label shall be white, the colours of the printing shall be black.

FIG. 6. Placard except as permitted by para. 571 minimum dimensions shall be as shown when different dimensions are used the relative proportions must be maintained. The number "7" shall not be less than 25 mm high. The background colour of the upper half of the placard shall be yellow and of the lower half white, the colour of the trefoil and the printing shall be black. The use of the word "RADIOACTIVE" in the bottom is optional to allow the alternative use of this placard to display the appropriate United Nations number for the consignment.

FIG. 7. Placard for separate display of United Nations number. The background colour of the placard shall be orange and the border and United Nations number shall be black. The symbol denotes the space in which the appropriate United Nations number for radioactive material, as specified in Table 8, shall be displayed.