Version No. 015
Health (Radiation Safety) Regulations 1994
S.R. No. 165/1994
Version incorporating amendments as at 20 September 2005
table of provisions
RegulationPage
1
RegulationPage
PART 1—PRELIMINARY
1.Objectives
2.Authorising provisions
3.Revocation
4.Definitions
PART 2—RADIOACTIVE SUBSTANCES
5.Radioactive substances for the purpose of the Act
6.Mixtures of radioactive substances
7.Prescribed circumstances for radioactive substances
8.Radioactive ores
9.Notification of prescribed circumstances for radioactive substances
PART 3—LICENCES
10.Classification of licences
11.Categories of licences—Operator Licence
12.Categories of licences—Company or Institution Licence
13.Licence fees
14.Requirement for licence for sale etc. of ionization chamber smoke detectors
15.Requirement for licence for sale etc. of ionizing radiation apparatus
PART 4—REGISTRATIONS
16.Notification of registration
17.Registration fee
PART 5—RADIATION SAFETY TESTING
18.Application of Part
19.Requirement for testing
20.Certificate of inspection
PART 6—EXEMPTIONS
21.Exemptions from licensing
22.Exemptions from registration—ionization chamber smoke detectors
23.Single station (domestic) ionization chamber smoke detectors
24.Commercial or industrial ionization chamber smoke detectors
25.Gaseous Tritium Light Devices
26.Depleted uranium
27.General exemption
28.Other exemptions
29.Exemption from medical examinations
PART 7—GENERAL SAFETY PRECAUTIONS
30.Application
31.Awareness of radiation hazards
32.Provision of training, instruction and safety devices
33.Control of radiation doses
34.Control of radiation doses to pregnant employees
35.Records of working rules and emergency plans
36.Reporting of abnormal or unplanned exposure to radiation
37.Reporting of out of control radiation sources
38.Reporting of damage or malfunction of a source of radiation
39.Reporting of loss or theft of a source of radiation
40.Reporting of contamination by a radioactive substance
41.Reporting of unintentional or accidental release of a
radioactive substance
42.Reporting of corrective actions taken
43.Obligations of employees or visitors
44.Containment and labelling of radioactive sources
45.Labelling of irradiating apparatus
46.Monitoring of contamination by radioactive substances
47.Limits for contamination by radioactive substances
48.Removal of clothing contaminated by radioactive substances
PART 8—CONTROL OF PATIENT DOSE
49.Use of ancillary equipment and procedures
50.Prohibition of non-screen film for medical purposes
51.Provision of radiographs
PART 9—PERSONAL MONITORING
52.Application
53.Personal monitoring requirements
54.Assessment of personal monitoring devices
55.Interference with personal monitoring devices or records
56.Personal monitoring records
57.Additional personal monitoring
PART 10—MEDICAL EXAMINATIONS
58.Requirements for medical examinations
59.Medical expenses
60.Results of medical examinations
PART 11—TRANSPORT OF RADIOACTIVE MATERIALS
61.Requirements for transport
62.Modification of Transport Code
63.Radioactive substances with other dangerous properties
64.Carrier requirements
65.Consignor requirements
66.Security of sources during transport
67.Damage to transport vehicle
68.Interference with packages
69.Authority to transport high activity radioactive sources
PART 12—DISPOSAL OF RADIOACTIVE WASTE
70.Limits on disposal
71.Disposal into open system
72.Boundary of site
73.Disposal into sewerage system
74.Disposal of unknown radioactive substance
75.Disposal of solid radioactive wastes
PART 13—ENFORCEMENT
76.Authority to inspect premises
77.Authority to seize apparatus
78.Authority to inspect records
79.Authority to request radiographs for inspection
PART 14—TRANSITIONAL
80.Transitional provision
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SCHEDULES
SCHEDULE 1—Radiation protection limits
SCHEDULE 2—Maximum amounts of radioactive substances
exempted from these Regulations
SCHEDULE 3—Weighting factors
SCHEDULE 4—Radiation warning symbol
SCHEDULE 5—Maximum concentrations of radioactive elements
in air and water above natural background
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ENDnotes
1. General Information
2. Table of Amendments
3. Explanatory Details
1
Version No. 015
Health (Radiation Safety) Regulations 1994
S.R. No. 165/1994
Version incorporating amendments as at 20 September 2005
1
Health (Radiation Safety) Regulations 1994
S.R. No. 165/1994
Part 1—Preliminary
1.Objectives
The objectives of these Regulations are—
(a)to remake with amendments the Health (Radiation Safety) (Interim) Regulations 1984;
(b)to protect persons and the environment from exposure to ionizing radiation to the maximum extent possible while recognising the need for use of radiation for medical, research and industrial purposes;
(c)to set fees;
(d)to prescribe other matters required or authorised to be prescribed under Division2AA of Part V of the Act.
2.Authorising provisions
These Regulations are made under sections 108AA, 108AB, 108AC, 108AD, 108AE, 108AF, 108AJ and 391 of the Health Act 1958.
3.Revocation
The Health (Radiation Safety) (Interim) Regulations 1994[1] are revoked.
4.Definitions
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In these Regulations—
"Act" means the Health Act 1958;
"activity" means, in relation to a radionuclide, the number of disintegrations of that radionuclide per unit time;
"approved" means approved by the Chief General Manager;
"carrier" means any individual, organization or government undertaking the carriage of radioactive material by any means of transport and includes both carriers for hire or reward and carriers on own account;
"consignment" means any package or packages or load of radioactive material presented by a consignor for transport;
"consignor" means any individual, organization or government that presents a consignment for transport and is named as consignor in the transport documents;
"depleted uranium" means uranium containing less than 072% of Uranium-235;
"effective dose" means the sum of the weighted equivalent doses in all the tissues and organs of the body and is determined by the formula
E =wTHT
T
whereE is the effective dose,
wT is the tissue weighting factor for tissue or organ T,
andHT is the equivalent dose in tissue or organ T;
"equivalent dose" means the absorbed dose averaged over a tissue or organ modified by the radiation weighting factor, wR, and is determined by the formula
HT =wRDT, R
R
whereHT is the equivalent dose in tissue or organ T
andDT,R is the absorbed dose averaged over the tissue or organ T, due to radiation R;
"irradiating apparatus" means ionizing radiation apparatus other than sealed source apparatus;
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Reg. 4 def. of "licensee" substituted by S.R. No. 14/1997 reg.5.
"licensee" means a person issued with a licence under section 108AF of the Act and includes a person registered by the Medical Radiation Technologists Board of Victoria to practice in radiography or nuclear medicine technology;
"medical exposure" means—
(a)an exposure to radiation incurred by an individual as part of that person's own medical diagnosis or treatment; or
(b)an exposure (other than occupational) incurred knowingly and willingly by an individual helping in the support and comfort of a patient undergoing diagnosis or treatment;
"operator licence" means a licence issued to a natural person described in Regulation 11;
"personal monitoring device" means a device worn by a person to monitor levels of ionizing radiation to which that person is exposed;
"radiation weighting factor, (wR)" means a factor given in Part 1 of Schedule 3 that modifies absorbed dose in an organ or tissue and is determined by the type and energy of the radiation to which the organ or tissue is exposed;
"recognized institution" means an institution recognized by the Chief General Manager for the purposes of these Regulations;
"site" means land together with its buildings where a registered person or licensee carries out his or her trade or business to which these Regulations apply;
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"tissue weighting factor, (wT)" means a factor given in Part 2 of Schedule 3 by which the equivalent dose in tissue or organ T is weighted and represents the relative contribution of that organ or tissue to the total detriment due to these effects resulting from uniform irradiation of the whole body;
"The Transport Code" means the "Code of Practice for the Safe Transport of Radioactive Substances (1990)" approved by order under section 9(1) of the Environment Protection (Nuclear Codes) Act 1978 of the Parliament of the Commonwealth and published for the Department of the Arts, Sport, the Environment, Tourism and Territories by the Australian Government Publishing Service.
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Part 2—Radioactive Substances
5.Radioactive substances for the purpose of the Act
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(1)A natural or artificial substance that emits ionizing radiation spontaneously and has a specific activity equal to or greater than 30 becquerels per gram is prescribed as a radioactive substance for the purposes of paragraph (a) of the definition of "radioactive substance" in section 108AB of the Act.
(2)A natural or artificial substance that emits ionizing radiation spontaneously and exceeds the maximum activity value for that substance specified in Table 1 of Schedule 2 is prescribed as a radioactive substance for the purposes of paragraph (a) of the definition of "radioactive substance" in section 108AB of the Act.
(3)A natural or artificial substance that emits ionizing radiation spontaneously and is not specified in Table 1 of Schedule 2 but exceeds 0004 megabecquerel is prescribed as a radioactive substance for the purposes of paragraph (a) of the definition of "radioactive substance" in section108AB of the Act.
6.Mixtures of radioactive substances
For the purpose of regulation 5(2), if a substance contains two or more radioactive substances and all are present in quantities less than the appropriate maximum activity value specified in Table 1 of Schedule 2, the resulting radioactive substance is a substance containing more than the prescribed amount referred to in regulation 5 if the sum of the fractions obtained by dividing the number of megabecquerels of each such substance present by the appropriate maximum activity value specified in Table 1 of Schedule 2 exceeds 1 (i.e"unity").
7.Prescribed circumstances for radioactive substances
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A substance that contains less than the prescribed amount in regulations 5 and 6 but which is used or is likely to be used so that an individual may receive an effective dose exceeding 10microsievert in a year is prescribed as a radioactive substance for the purposes of paragraph (b) of the definition of "radioactive substance" in section 108AB of the Act.
8.Radioactive ores
A radioactive ore that is a natural radioactive substance and contains less than the prescribed amount in regulations 5 and 6 but in the opinion of the Chief General Manager may—
(a)give rise to a radiation hazard; or
(b)result in an individual receiving an effective dose exceeding 10 microsievert in a year—
when that radioactive substance is mined or milled is prescribed as a radioactive substance for the purposes of paragraph (b) of the definition of "radioactive substance" in section 108AB of the Act while it is being mined or milled.
9.Notification of prescribed circumstances for radioactive substances
(1)If the circumstances set out in regulations 7 or 8 apply, the Chief General Manager must forthwith notify each user of the radioactive substance concerned in writing that the user is required to comply with these regulations in respect of that radioactive substance.
(2)For the purpose of sub-regulation (1), "user", in relation to a radioactive substance, includes manufacturer, storer, transporter, seller, possessor, miner, miller, or other dealer of or with the radioactive substance.
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Part 3—Licences
10.Classification of licences
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The Chief General Manager may issue licences under section 108AF of the Act for the following—
(a)irradiating apparatus;
(b)sealed source apparatus;
(c)sealed radioactive sources;
(d)unsealed radioactive sources;
(e)a combination of 2 or more of the classifications set out in paragraphs (a) to(d).
11.Categories of licences—Operator Licence
The Chief General Manager may issue an operator licence to a person in respect of that person's profession or occupation as—
(a)a radiologist;
Reg. 11(b) revoked by S.R. No. 14/1997 reg.6(a).
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(c)a radiation oncologist;
Reg. 11(d) revoked by S.R. No. 14/1997 reg.6(a).
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(e)a nuclear medicine specialist;
Reg. 11(f) revoked by S.R. No. 14/1997 reg.6(a).
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Reg. 11(g) amended by S.R. No. 14/1997 reg.6(b).
(g)a registered medical practitioner;
(h)a dentist;
(i)a chiropractor;
(j)a dermatologist;
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(k)an ophthalmologist;
(l)a cardiologist;
Reg. 11(m) amended by S.R. No. 14/1997 reg.6(c).
(m)a medical specialist not specified in paragraphs (a), (c), (e), (j), (k) and (l);
(n)a paramedic;
(o)a radiation apparatus tester;
(p)a radiation apparatus service technician;
(q)a medical or scientific researcher whose work involves irradiation of human volunteers;
(r)a veterinarian;
(s)an industrial radiographer;
(t)a radiation consultant;
(u)a dental therapist;
(v)a dental hygienist;
(w)a borehole logger;
(x)a portable moisture/density meter operator;
(y)any other approved category.
12.Categories of licences—Company or Institution Licence
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(1)The Chief General Manager may issue a licence other than an operator licence to—
(a)a company or proprietor or a business selling or servicing ionizing radiation apparatus or radioactive substances; or
(b)a contract transport company or proprietor of a contract transport business; or
(c)an institution carrying out research involving irradiation of human volunteers; or
(d)an institution or employer that or who employs a person to operate, use or otherwise deal with an unsealed radioactive source.
(2)A licence issued under sub-regulation (1)(d) may be issued in relation to one specified site or may otherwise restrict the extent of the operations under the licence.
13.Licence fees
Reg. 13(1) amended by S.R. Nos 49/1996 reg.5(a), 81/2002 reg.5(1), 65/2003 reg.5(1), 116/2005 reg.3(a).
(1)The fee to be paid for the issue of an operator licence is 101 fee units.
Reg. 13(2) amended by S.R. Nos 49/1996 reg.5(b), 81/2002 reg.5(2), 65/2003 reg.5(2), 116/2005 reg.3(b).
(2)The fee to be paid for the issue of a licence other than an operator licence is 331 fee units.
14.Requirement for licence for sale etc. of ionization chamber smoke detectors
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For the purposes of safeguarding the public or any section of the public, a person who, whether an agent or on his or her own account, manufactures, stores, sells, disposes of or otherwise deals with ionization chamber smoke detectors must—
(a)before so manufacturing, storing, selling, disposing of or otherwise dealing, demonstrate to the Chief General Manager that detectors of that type conform to the requirements of a testing authority nominated by the Chief General Manager; and
(b)not offer for sale an ionization chamber smoke detector other than a detector approved by the Chief General Manager for sale.
Penalty:25 penalty units.
15.Requirement for licence for sale etc. of ionizing radiation apparatus
For the purposes of safeguarding the public or any section of the public, a person, whether an agent or on his or her own account, who manufactures, stores, sells, disposes of or otherwise deals with any ionizing radiation apparatus must not offer for sale an ionizing radiation apparatus other than an apparatus approved by the Chief General Manager for sale.
Penalty:50 penalty units.
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Part 4—Registrations
16.Notification of registration
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(1)A person to whom a notification of registration has been issued for an irradiating apparatus or sealed source apparatus registered under the Act must affix and keep affixed to that apparatus the registration label provided by the Chief General Manager which applies to that apparatus.
Penalty:10 penalty units.
(2)A person to whom a notification of registration has been issued for a sealed radioactive source registered under the Act must affix and keep affixed to the container of that source the registration label provided by the Chief General Manager which applies to that source.
Penalty:10 penalty units.
17.Registration fee
(1)Before registration of any irradiating apparatus, sealed radioactive source or sealed source apparatus, the applicant must pay the relevant fee set out in column 3 of the Table to this regulation.
(2)Before temporary registration of any irradiating apparatus, sealed radioactive source or sealed source apparatus, the applicant must pay the relevant fee set out in column 4 of the Table to this regulation.
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Table amended by S.R. No. 49/1996 reg.6(a)(i)–(iv), (b)(i)–(iv), substitutedby S.R. Nos 81/2002 reg.6, 65/2003 reg.6, 116/2005 reg.4.
TABLE
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Column 1 / Column 2 / Column 3 / Column 4Fee Category / Equipment Type / Registration Fee / Temporary Registration Fee
Category 1 (Irradiating apparatus) / Dental X-ray units, orthopantomographic (OPG) X-ray units, cephalometric X-ray units, mobile medical X-ray units, veterinary X-ray units, X-ray gauges, other irradiating apparatus not specified in this Table. / 108 fee units / 53 fee units
Category 2 (Irradiating apparatus) / Industrial radiography X-ray units, fixed medical X-ray units, mammography X-ray units, X-ray analysis units, chiropractic Xray units, mobile image intensifiers, medical therapy simulators, X-ray therapy units not operable above 500kilovolt peak (kVp). / 267 fee units / 133 fee units
Column 1 / Column 2 / Column 3 / Column 4
Fee Category / Equipment Type / Registration Fee / Temporary Registration Fee
Category 3 (Irradiating apparatus) / Accelerators used for university research, computer tomography units, medical cyclotrons, medical linear accelerators, industrial electron beam accelerators, Xray therapy units operable above 500kilovolt peak (kVp). / 543 fee units / 268 fee units
Category 4 (Sealed radio-active source) / Static eliminators using Polonium-210, static meters using Tritium sources of activity up to 185gigabecquerels, electron capture sources for gas chromatography, any sealed radio-active source with activity not greater than 40megabecquerels. / 47 fee units / 24 fee units
Category 5 (Sealed radio-active source) / Calibration sources, radiation gauges with activity not greater than 40gigabecquerels, portable nuclear moisture/density meters, other sealed radio-active sources not specified in this Table. / 108 fee units / 53 fee units
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Column 1 / Column 2 / Column 3 / Column 4Fee Category / Equipment Type / Registration Fee / Temporary Registration Fee
Category 6 (Sealed radio-active source) / Industrial radiography sources, medical therapy sources (dermatology and ophthalmology), medical therapy sources with activity less than 400gigabecquerels, borehole logging sources, veterinary radiotherapy sources, radiation gauges with activity greater than 40 gigabecquerels. / 267 fee units / 133 fee units
Category 7 (Sealed radio-active source) / Self-shielded laboratory irradiators, irradiation cell sources for sterilization purposes, research irradiation cell sources, medical therapy sources of activity not less than 400 gigabecquerels. / 543 fee units / 268 fee units
(3)For the purpose of this regulation the activity of a sealed radioactive source is—
(a)at initial application, the activity of the source at the time of application for registration; or
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(b)at renewal of registration, the activity of the source at the expiry of the registration.
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Part 5—Radiation Safety Testing
18.Application of Part
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(1)If the Chief General Manager so directs, before an ionizing radiation apparatus, sealed radioactive source or sealed source apparatus can be registered, it must be tested in accordance with this Part.
(2)This Part also applies to ionizing radiation apparatus, a sealed radioactive source or sealed source apparatus required to be tested by a condition of its registration.
19.Requirement for testing
The registered person or person applying for registration in respect of an ionizing radiation apparatus, sealed radioactive source or sealed source apparatus must ensure that the apparatus or source is tested for compliance with any radiation safety tests specified by the Chief General Manager.
Penalty:25 penalty units.
20.Certificate of inspection
A person who tests an apparatus or source must not issue a certificate of radiation safety testing if a radiation safety test shows that the apparatus or source does not pass any radiation safety test specified by the Chief General Manager.
Penalty:25 penalty units.