Radiation Regulations 2017

The Regulations operationalise several statutory concepts in the Radiation Act 2005 by defining numerical thresholds, equipment lists and administrative rules. The key legal concepts the Regulations fix are: radioactive material, prescribed radiation facility, prescribed radiation source, certificate of compliance, licence fees and dose limits.

1. Radioactive material: The Regulations prescribe numeric thresholds for activity concentration and total activity for a very wide list of radionuclides in Schedule 1; reg 6 expressly ties those numbers to the definition of “radioactive material” in s 3(1) of the Act. For a single radionuclide, the activity concentration threshold is the Column 2 value and the activity threshold is Column 3 in Schedule 1 (reg 6(a)-(b)). For combinations, reg 7 prescribes a two-part test: the sum of the fractions (activity concentration present divided by the Schedule 1 Column 2 value) across the radionuclides must be equal to or exceed 1; and simultaneously the sum of the fractions (activity present divided by Schedule 1 Column 3 value) must be equal to or exceed 1, before the combination is treated as radioactive material for the Act.

2. Identification documents: For the Act’s identification requirement the Regulations prescribe that an applicant must produce at least one original document from each of four categories in Schedule 2 (reg 8(1)). That means, in normal cases, a licence applicant must supply four separate original documents, one from each category. The Regulations, however, list specific exemptions: an Aviation Security Identification Card or a Maritime Security Identification Card issued under relevant Commonwealth legislation substitutes for the Schedule 2 set (reg 8(2)).

3. Prescribed radiation facility: The Regulations expand the Act’s definition of a radiation facility by specifically including premises used or proposed to house, possess, store or permit the use of any “high consequence sealed source or high consequence group of sealed sources” (reg 9). This mechanically brings such premises within the Act’s facility rules.

4. Activity ratios and D-values: Regulation 10 implements the Act’s section 3A activity-ratio formula by specifying which radionuclides are “prescribed radionuclides” for the A value in the formula and by giving the D-value (in GBq) for each in Schedule 3. Practitioners must therefore consult Schedule 3 when applying the section 3A sealed-source activity-ratio test.

5. Radiation dose limits: Regulation 11 locates the dose ceilings that apply under section 22(1)-(2) of the Act by reference to Schedule 4. Schedule 4 sets separate occupational (Table A) and public (Table B) dose limits, and provides specific limits in 12‑ and 60‑month windows and for lenses, skin, hands and feet. Regulation 11 also clarifies the special handling for a pregnant woman who has notified her relevant management licence holder: the uterus receives the public exposure limit while other parts remain subject to the occupational limit (reg 11(1)(c)(i)-(ii)).

6. Prescribed radiation sources and certificates of compliance: Regulation 12 identifies the diagnostic radiation sources that require a certificate of compliance prior to use by reference to Schedule 5; Schedule 5 lists plain radiographic X‑ray equipment, fluoroscopic equipment, computed tomography scanners and mammographic equipment. Regulation 13 prescribes the expiry dates for certificates of compliance for each listed source type using Schedule 6 (CT and mammography 12 months; radiographic and fluoroscopic equipment 2 years).

7. Fees and fee mechanics: The Regulations use fee units to set fees. Application fees are composed of an application processing component (explicitly separated in regs 14-16) and a term component depending on whether the application is for one, two or three years. Schedule 7 sets the fee-unit quantum for management licences depending on the class or activity of the radiation source (for example CT, cyclotron and linear or particle accelerators attract higher fee units; sealed sources are tiered by activity). The explanatory details note the fee-unit value for 2017-18 was $14.22 and that fee units for future years are fixed by the Treasurer under the Monetary Units Act 2004 (endnotes and explanatory details).

8. Administrative discretions and procedural rules: The Secretary is given express powers and duties: to refund the “relevant authority fee component” if an application is refused or withdrawn prior to decision (reg 20); to reduce, waive or refund the application processing component of the use-licence fee (reg 21); and to treat certain security-plan amendments as prescribed (reg 22, which cross-references s 67F(2)(c) of the Act). These rules shape which administrative costs are avoidable and which are refundable.

9. Revocation and sunset: The Regulations revoke the earlier Radiation Regulations 2007 and the 2008 tanning units/fees amending regulations (reg 4). The endnotes record the making date (8 August 2017), the commencement date (27 August 2017) and the sunset provision under the Subordinate Legislation Act 1994 (10 years after making, endnotes).

In short, the Regulations translate statutory standards in the Act into operational numerical and documentary requirements that determine when licensing and other administrative controls apply and what those controls cost in licence fees and compliance activities.

The Regulations affect several discrete groups, and the source makes clear who bears duty and cost in different situations.

• Licence applicants and authority holders: Persons or entities that apply for use licences, management licences to possess radiation sources, or tester approvals are directly affected. Regulation 14 prescribes the fee components for applications for use licences; regulations 15 and 16 prescribe application fees for management licences and tester approvals respectively; and regulations 17-19 prescribe renewal fees. Schedule 7 contains the fee-unit amounts that apply to particular types of radiation sources and apparatus. The entity applying for or renewing a licence pays the fees and must supply identification documents under reg 8 where applicable.

• Operators and owners of radiation equipment and sources: Those who own or operate the specified diagnostic X‑ray equipment in Schedule 5 must hold a current certificate of compliance before use (reg 12), and must renew such certificates within the expiry periods set in Schedule 6 (reg 13). Owners or operators of sealed sources and other radioactive material must measure and compare activities to Schedule 1 thresholds and apply the Act’s licensing regime accordingly (regs 6-7 and Schedule 1).

• Workers exposed to radiation: Employers and management licence holders who conduct radiation practices or permit use of sources must ensure occupational doses remain within the Schedule 4 Table A limits (reg 11). The Regulations also allocate a distinct rule for pregnant workers who notify their relevant management licence holder, by linking the uterus limit to the public exposure limit while leaving other body-part limits under occupational limits (reg 11(1)(c)). This alters employer risk allocation for pregnant employees.

• The Secretary and regulatory administrators: The Secretary is both a decision-maker and an administrative payer/receiver in several places. The Secretary must refund “relevant authority fee components” in specified circumstances (reg 20), may reduce/waive/refund the application processing component of use-licence fees (reg 21), and will review submitted security-plan amendments under s 67F(2)(c) with the prescribed list in reg 22. The Secretary’s discretion over fee reduction and refund, and the refund obligation where an application is refused or withdrawn, shape administrative incentives for applicants and for the regulator.

• Healthcare providers and diagnostic services: Medical imaging providers using plain radiographic, fluoroscopic, CT and mammography equipment must ensure certificates of compliance are current (regs 12-13 and Schedules 5-6). Certificate expiries for CT and mammography are 12 months, which implies a higher frequency of equipment testing or compliance checks compared with the two-year expiry for other imaging equipment in Schedule 6.

• Maritime and aviation workers with security IDs: The Regulations exempt holders of an Aviation Security Identification Card and Maritime Security Identification Card (Commonwealth-issued) from the four-document identity requirement in reg 8(1) (reg 8(2)(a)-(b)). This means certain workforce categories can use their Commonwealth security ID instead of producing originals from each of the four categories in Schedule 2.

• Users and handlers of sealed sources and high consequence sealed sources: The prescription that a “prescribed radiation facility” includes premises used to house or use high consequence sealed sources brings premises containing such sources within the Act’s regulatory reach (reg 9). Schedule 3 D-values provide the activity levels used in the activity-ratio test in s 3A of the Act; owners and operators of sealed sources must compare their sources to those D-values to determine regulatory status.

• Entities that supply, test or inspect radiation devices: Tester approvals and their fees are set out (reg 16 and reg 19), so third-party testers and service providers are affected by the regulatory obligations to obtain and renew approvals and to pay the stated fees.

Who decides: The Secretary decides applications under the Act and the Regulations; the Secretary also has express power to reduce, waive or refund processing fee components (reg 21) and must refund certain fee components if the application is refused or withdrawn (reg 20). The Act remains the source of enforcement, appeal and offence mechanisms; the Regulations set thresholds and administrative detail that will feed into those enforcement processes.

Who pays: Licence applicants and holders pay the fees calculated under regs 14-19 and Schedule 7, with monetary amounts derived by multiplying fee units by the monetary unit set under the Monetary Units Act 2004 (explanatory details). Certificate holders pay for compliance steps needed to obtain and renew certificates of compliance within the expiry periods set in Schedule 6. Employers and licence holders bear the cost of monitoring occupational doses to the Schedule 4 limits.

The Regulations set duties for licence applicants, management licence holders, operators of prescribed radiation sources, and the Secretary. They also allocate rights such as refunds and administrative discretion.

Duties on applicants and licence holders

• Measure and classify radioactive material: Persons must assess use or possession of material against the activity concentration and activity levels in Schedule 1 to determine whether material is “radioactive material” for the Act (reg 6). If multiple radionuclides are present, the combination test in reg 7 applies and both fraction sums (for activity concentration and activity) must meet or exceed 1 for the combination to be radioactive material for the Act.

• Produce identification documents: An applicant must supply at least one original from each Schedule 2 category to satisfy the Act’s identification document requirement (reg 8(1)). This creates a four-document original requirement in routine cases. The applicant can, instead, produce a Commonwealth Aviation or Maritime Security Identification Card to avoid the four-document set (reg 8(2)).

• Hold certificates of compliance for prescribed diagnostic sources before use: Any use of a radiation source specified in Schedule 5 for human diagnostic purposes requires a current certificate of compliance prior to use (reg 12). Certificate expiry periods are set in Schedule 6 and must be respected (reg 13).

• Observe dose limits: Employers and management licence holders must ensure occupational and public exposures do not exceed the prescribed radiation dose limits in Schedule 4 as applied under s 22(1)-(2) of the Act and reg 11. Employers must also apply the special rule for pregnant women who have notified the relevant management licence holder: the uterus is subject to the public exposure limit while other body parts remain subject to the occupational limit (reg 11(1)(c)).

• Pay application and renewal fees: Applicants must pay fees as prescribed in regs 14-19 and Schedule 7. Fees are set in fee units and vary according to the licence category, term length and type/quantity of sources possessed or practices conducted.

• For sealed sources and facilities: Operators must check activity ratios for sealed sources against Schedule 3 D-values when applying section 3A of the Act (reg 10). Premises housing high consequence sealed sources are prescribed as radiation facilities (reg 9), which will impose any duties under the Act on facility operators.

Secretary’s duties and powers

• Refund requirement: The Secretary must refund the “relevant authority fee component” to an authority applicant if the Secretary refuses to issue or renew the authority or the applicant withdraws before decision (reg 20(1)). The regulation defines “relevant authority fee component” by cross-reference to the fee components listed in regs 14-19 (reg 20(2)).

• Discretion to reduce/waive/refund processing component: The Secretary may reduce, waive or refund payment of the application processing component of the prescribed use-licence fee (reg 21). This power applies to the processing component specified in reg 14(a).

• Review of security plans: For the purposes of s 67F(2)(c) of the Act, the Regulations prescribe what is a prescribed amendment to an approved security plan. The Secretary will treat amendments that have no material impact and routine replacement identification amendments as prescribed (reg 22). Those items include manufacturer name, serial number, measured activity and date of measurement and similar fields (reg 22(b) and subitems).

Rights and procedural outcomes

• Right to refund: Applicants who have had an application refused or who withdraw before decision are entitled to a refund of the prescribed authority fee component (reg 20). The Regulations also allow the Secretary to exercise discretion on processing-fee reduction or waiver (reg 21), creating a potential right to relief from at least part of the application cost.

• Time-limited use and renewal obligations: Certificate holders have the right to continue use of equipment during the certificate period specified in Schedule 6, but the right to use is time-limited; renewal applications and fees are prescribed (regs 17-19). Certificates for CT and mammography last 12 months; plain radiographic and fluoroscopic equipment certificates last 2 years (Schedule 6).

• Procedural predictability: The numeric thresholds, lists and fee schedules create predictable rules for classification, fee calculation and administrative timeframes. Applicants know which documents satisfy identity requirements, what radionuclide levels trigger licensing, what D-values apply for sealed sources, and what administrative charges will be levied.

Limits and caveats

• The Regulations themselves do not set out criminal penalties or enforcement procedures; those are in the Radiation Act 2005. The Regulations interface with the Act (reg 2), and many of their provisions are framed as instruments for use by decision-makers under particular sections of the Act (for example, reg 6 references the definition in s 3(1); reg 10 references s 3A; reg 11 references s 22(1)-(2); reg 13 references s 33; reg 22 references s 67F(2)(c)). Consequently, duties set by the Regulations will usually be enforced or operationalised through Act processes and powers.

The Regulations themselves do not create new offence provisions or specify penalty amounts. Enforcement and penalty mechanisms remain within the Radiation Act 2005; the Regulations operate as technical and administrative implementers of the Act. The text repeatedly cross-references the Act (see reg 2 and throughout), which signals that regulatory non‑compliance will generally be addressed under the Act’s enforcement framework.

How enforcement will operate in practice, as derived from the Regulations:

• Administrative preconditions that can trigger enforcement: The Regulations make certain administrative preconditions explicit. For example, reg 12 prescribes that a certificate of compliance is required prior to the use of prescribed diagnostic radiation sources (Schedule 5). Using such equipment without a current certificate (which must meet the Schedule 6 expiry periods under reg 13) will render the user liable to enforcement under the Act (the Act is the statutory source of offences and powers; the Regulations identify what must be in place).

• Licencing and fee compliance: Fees for applications and renewals are set in regs 14-19 and Schedule 7. Failure to pay required fees or to hold a required licence or approval (use licence, management licence, tester approval) will mean a person is operating outside the Act’s legal authorisation and therefore subject to enforcement pursuant to the Act.

• Secretary’s administrative powers and remedies: The Secretary must refund relevant authority fee components where an application is refused or withdrawn prior to a decision (reg 20), and may reduce or waive the processing component of a use-licence fee (reg 21). These administrative remedies affect the net cost of regulatory compliance. The Secretary also reviews prescribed security-plan amendments under s 67F(2)(c) with the guidance of reg 22; failure to maintain an approved security plan where required can be the subject of enforcement under the Act.

• Dose-limit monitoring and employer obligations: Schedule 4 dose limits (applied under reg 11) create measurable occupational and public exposure ceilings. Enforcement under the Act will follow where employers or licence holders do not ensure those limits are met. The Regulations do not, however, specify monitoring protocols, reporting thresholds, or sanction procedures for dose-overruns; those procedural aspects sit within the Act or administrative guidance.

• Interaction with other regulatory regimes: The Regulations reference Commonwealth-level security ID schemes (reg 8(2)) and various State Acts for identity documents in Schedule 2. Those cross-references are connectivity points: enforcement for identity-related fraud would fall under general criminal laws, and enforcement for aviation/maritime security IDs is a Commonwealth matter.

What the Regulations do not do on enforcement:

• They do not list penalty units or fines, nor do they state time-limited infringement notices or Schedule of offences. For specific sanction amounts, practitioners must consult the Radiation Act 2005 and any subsidiary penalty instruments under that Act. The Regulations instead create compliance triggers (technical thresholds, certificate expiry dates, licence-fee schedules) that feed into the Act’s enforcement machinery.

• They do not set out inspection regimes, reporting formats or mandatory monitoring frequencies (beyond the periodicity implied by certificate expiry periods). Agencies will rely on the Act and administrative policy to implement monitoring and inspection operations.

Practical implication for compliance and enforcement planning

• Regulators will use the Regulations to determine whether materials, sources or premises fall within the Act’s remit (Schedules 1 and 3; regs 6-10). Once within the Act’s ambit, enforcement uses the Act’s offence and remedy provisions. Licence holders and operators must therefore ensure that the administrative preconditions reflected in the Regulations (licences, certificates, fees, identity documentation) are satisfied to avoid regulatory action.

• The Secretary’s refund duty and waiver powers create limited administrative relief from fees, but they do not alter enforcement of other substantive requirements such as holding valid certificates or ensuring dose limits are observed.

The Regulations are a subordinate instrument under the Radiation Act 2005 (reg 2). They explicitly interact with multiple other statutes and instruments; the source sets out several cross-references that determine legal interplay and administrative convenience.

Primary interaction: Radiation Act 2005

• The Regulations operationalise numerous definitions and powers in the Radiation Act 2005. They supply values used in statutory definitions (reg 6 references s 3(1); reg 10 references s 3A; reg 11 references s 22(1)-(2); reg 13 references s 33; reg 22 references s 67F(2)(c)). Enforcement, offences, appeals and delegated decision-making procedures remain governed by the Act; the Regulations narrow the Act’s scope in practice by setting lists and numeric thresholds.

Monetary Units Act 2004

• The Regulations prescribe fees using fee units (regs 14-19; Schedule 7). The explanatory details clarify that the Monetary Units Act 2004 supplies the method to calculate the dollar equivalent: multiply the number of fee units by the fee unit value for the relevant financial year, with the 2017-18 fee unit value stated at $14.22 (explanatory details, endnotes). The Treasurer fixes future fee-unit values under the Monetary Units Act 2004, and publication requirements for the value are noted.

Commonwealth security and transport regulations

• Regulation 8(2) exempts holders of an Aviation Security Identification Card (issued under the Aviation Transport Security Regulations 2005 of the Commonwealth) and a Maritime Security Identification Card (issued under the Maritime Transport and Offshore Facilities Security Regulations 2003 of the Commonwealth) from the Schedule 2 four-document identity requirement. This creates a direct interaction point between State licensing procedure and Commonwealth security IDs.

State Acts referenced in identity documents

• Schedule 2 (identification documents) cites State and Territory legislation as sources for certain identity documents, including the Road Safety Act 1986 (driver licences), Firearms Act 1996 (firearms licences), Liquor Control Reform Act 1998 (proof of age cards), Residential Tenancies Act 1997 (tenancy agreements) and Private Security Act 2004 (private security licences). Those Acts are therefore indirectly implicated in identity verification for radiation licences.

Subordinate Legislation Act 1994 and Interpretation of Legislation Act 1984

• Endnotes record that the Regulations were made 8 August 2017 and will sunset 10 years later under the Subordinate Legislation Act 1994 (endnotes 1 and explanatory details). The endnotes also address interpretation issues arising from the Interpretation of Legislation Act 1984, noting that headings, notes and examples form part of the Statutory Rule and that other interpretative changes apply (endnotes, Interpretation section). These interpretative cross-references affect how the Regulations are read and applied.

Health and medical regulation

• By prescribing particular diagnostic equipment as “prescribed radiation sources” and attaching certificate-of-compliance requirements and expiry periods (regs 12-13 and Schedules 5-6), the Regulations intersect with healthcare regulation, clinical governance and compliance regimes. Although the Regulations do not reference health Acts directly, clinical operators must align certificate regimes with other health quality and safety obligations.

Other administrative regulations

• The revocation of the Radiation Regulations 2007 and the Radiation Amendment (Tanning Units and Fees) Regulations 2008 (reg 4) means previous subordinate instruments are displaced; practitioners must rely on the 2017 Regulations for current thresholds and fees. The explanatory details indicate no amendments at the time of printing.

Practical consequence of these interactions

• Licence applicants must manage compliance across multiple instruments: they must apply the numeric thresholds and equipment lists in the Regulations, compute fees using the Monetary Units Act 2004 fee-unit mechanism, provide identity documents that may be issued under other Acts, and anticipate that enforcement will proceed under the Radiation Act 2005. Commonwealth security IDs may substitute for multi-document identity proof in certain industry contexts. The interpretative rules in the Interpretation of Legislation Act 1984 affect how the Regulations’ headings, notes and examples are treated for legal construction.

The source (endnotes and Table of Amendments) records the following amendment history and related formalities.

• Making and commencement: The Regulations were made on 8 August 2017 by the Governor in Council and commenced operation on 27 August 2017 (reg 3; endnotes 1 and explanatory details).

• Revocations on commencement: The Regulations revoke the Radiation Regulations 2007 and the Radiation Amendment (Tanning Units and Fees) Regulations 2008 (reg 4(a)-(b); explanatory details indicate S.R. No. 89/2007 as amended and S.R. No. 167/2008).

• Amendments since making: The Table of Amendments included in the source states that there are no amendments made to the Radiation Regulations 2017 by statutory rules, subordinate instruments or Acts at the date of this publication (endnotes 2, Table of Amendments).

• Amendments not in operation: The source records that there are no amendments not in operation at the date of publication (endnotes 3).

• Sunset provision: The Regulations will sunset 10 years after the day of making (8 August 2027) pursuant to section 5 of the Subordinate Legislation Act 1994 (endnotes).

• Fee unit valuation and updating: The explanatory details note that the Regulations refer to fee units per the Monetary Units Act 2004 and record the fee unit value for the financial year starting 1 July 2017 as $14.22; the value for future years is fixed by the Treasurer and must be published in the Government Gazette and a Victorian newspaper before 1 June in the preceding financial year (explanatory details).

• No amendments in the source text post‑2017 are recorded: Practitioners should check the current legislation database beyond this source to confirm whether later amendments have been made, but the source itself shows no post‑2017 amendments at the date of the version provided.

In short, the 2017 Regulations replaced the earlier 2007 instrument and its 2008 amendment on the dates specified, and as printed in the source there are no subsequent amendments. The instrument is subject to statutory sunset in 2027 under the Subordinate Legislation Act 1994.

The provided source contains no case law citations and the Table of Amendments and endnotes indicate there are no recorded amendments or litigation references within the instrument itself. The Regulations name no cases and the endnotes do not list any judicial determinations challenging or interpreting these Regulations.

Accordingly, within the scope of the text supplied:

• There is no recorded litigation history cited in the Regulations or endnotes.

• No judgments or appeals are referenced, and the instrument does not list any court rulings that interpret thresholds, fees or administrative discretions contained in these Regulations.

Practical note for practitioners: The absence of litigation references in the Regulations does not mean the Regulations have not been litigated in the courts; it means the source document contains no litigation history. To identify any judicial interpretation or dispute concerning the Regulations, practitioners must search case law databases and tribunal records external to this instrument. If a client needs to predict how a court will treat particular numeric thresholds (for example, the Schedule 1 combination test in reg 7) or the Secretary’s discretion under reg 21, that prediction must be based on case law research from judicial and tribunal records, which the Regulations themselves do not provide.

The Regulations contain technical details and drafting points that commonly produce compliance or interpretative traps for lawyers, licensees and compliance officers. Below are concrete “gotchas” grounded in the Regulations and their Schedules.

1. Combination test requires two simultaneous sums (reg 7). When multiple radionuclides occur in combination, the combination is radioactive material for the Act only if both of the following hold: (a) the sum across radionuclides of (activity concentration present ÷ Schedule 1 Column 2 value) ≥ 1, and (b) the sum across radionuclides of (activity present ÷ Schedule 1 Column 3 value) ≥ 1 (reg 7(a)-(b)). Practitioners might assume only one of these tests suffices; both must be satisfied.

2. Schedule 1 parent-progeny caveats and secular equilibrium (Schedule 1 note a). Several radionuclides in Schedule 1 are listed with an “a” footnote stating the levels are for the parent radionuclide assumed to be in secular equilibrium with progeny listed below. This affects measurement and classification: practitioners must account for equilibrium assumptions when labelling a sample and comparing it to the schedule numbers.

3. Identification-document burden (reg 8 and Schedule 2). The default requirement is “at least one original document from each of the following categories” (reg 8(1)), i.e. one from Category 1, one from Category 2, one from Category 3 and one from Category 4. That means four originals in many cases. The only routine exceptions are Commonwealth aviation and maritime security IDs (reg 8(2)). Entities that accept photocopies or fewer documents may be non-compliant.

4. Fee composition and the processing component split (regs 14-16, 20-21). Application fees are made of an “application processing component” (for example 4.5 fee units for a use-licence in reg 14(a)) and a licence-term component (reg 14(b)). If an application is refused or withdrawn, reg 20 requires the Secretary to refund the “relevant authority fee component,” which the regulation defines to mean the licence-term part (reg 20(2) cross-referencing regs 14(b) and 15(1)(b) etc). The Secretary’s refund duty does not automatically extend to the application processing component; however reg 21 gives a separate discretion to reduce, waive or refund that processing component for use-licence applications only. Practitioners should not assume a full automatic refund of the whole application fee if an application is refused.

5. Different fee treatment for multiple sources (reg 15(2)). For management licences to possess more than one radiation source specified in Schedule 7, the fee is the processing component plus the sum of the fee-unit amounts for each of the sources. This can produce higher aggregated fees that scale with the number and class of sources.

6. Certificate expiry variability (reg 13 and Schedule 6). Certificates of compliance for CT scanners and mammographic X‑ray equipment expire after 12 months, whereas plain radiographic and fluoroscopic equipment certificates expire after two years (Schedule 6). Operators of CT and mammography equipment must budget and plan for more frequent compliance steps.

7. Activity-ratio D-values are given in GBq and are specific (reg 10 and Schedule 3). Where sealed-source activity calculations under s 3A of the Act require a D-value input, Schedule 3 must be used; the D-values vary widely (for example Americium-241 has a D-value of 60 GBq; technetium‑99m 700 GBq; tritium 2 × 10^6 GBq). Units and conversions matter: practitioners must ensure activity calculations use the same units (GBq) as Schedule 3.

8. Prescribed radiation facility covering “high consequence” sealed sources (reg 9). The Regulations expand that definition specifically to premises housing “high consequence sealed source or high consequence group of sealed sources.” The term “high consequence” is not numerically defined in the Regulations themselves; operators should consult the Act and administrative guidance to determine whether their sealed sources are “high consequence,” as the designation will change facility licensing and security obligations.

9. Dose limits are rolling windows (Schedule 4). Table A sets occupational limits in both 60‑month and 12‑month periods for effective dose and lens exposure, and likewise for skin and extremities in 12‑month windows. Compliance systems must account for both the immediate 12‑month limit and the cumulative 60‑month limit to avoid inadvertent breaches.

10. Fee-unit calculation and annual updates (explanatory details). Fees in dollar terms change each financial year because they are specified in fee units and the Monetary Units Act 2004 requires the Treasurer to fix the dollar value each year and publish it. Practitioners must calculate fees according to the up-to-date fee-unit value rather than relying on a fixed dollar figure listed in older guidance.

11. Refunds only where an application is refused or withdrawn before decision (reg 20). If an applicant withdraws after decision or if an application is refused after the Secretary has decided, the refund duty in reg 20 does not apply. Practitioners dealing with partial withdrawals or post‑decision actions should track timing carefully.

12. Security-plan amendments regarded as prescribed (reg 22). Minor administrative changes such as serial number or measured activity and date of measurement may be treated as prescribed amendments that have no material impact; however, reg 22 requires that the amendment genuinely has no material impact or is only a routine replacement identification. Misclassifying a material security change as routine could have regulatory consequences.

13. No enforcement or penalty schedules in the Regulations. Because the Regulations do not contain penalty provisions, practitioners must map non-compliance to the Act’s offences and enforcement mechanisms to understand sanction exposure.

14. Broad radionuclide list with “not mentioned” catch-alls (Schedule 1). Schedule 1 contains generic lines such as “alpha-emitting radionuclide not mentioned in this Table” with numeric thresholds. These catch-all entries demand careful labelling and radiochemistry expertise to ensure correct classification, especially where new or uncommon radionuclides are involved.

Compliance with the Radiation Regulations 2017 requires technical measurement, administrative process, record-keeping and recurring renewal activity. The steps below map to the Regulations and Schedules and indicate practical actions an operator, licence applicant or compliance adviser should take.

1. Classify material against Schedule 1 and reg 7

• Obtain radionuclide assay data: For any material suspected of containing radionuclides, obtain laboratory measurements sufficient to calculate both activity concentration (Bq/g) and total activity (Bq) for each radionuclide present.

• Compare to Schedule 1: Use Schedule 1 Column 2 (activity concentration Bq/g) and Column 3 (activity Bq) to determine whether single-radionuclide thresholds are exceeded (reg 6). For mixtures, apply the combination test in reg 7: compute the sum across radionuclides of (activity concentration present ÷ Schedule 1 Column 2 value) and the sum of (activity present ÷ Schedule 1 Column 3 value). The mixture is “radioactive material” for the Act only if both sums are ≥ 1.

• Account for parent-progeny equilibrium: If the radionuclide is a parent with listed progeny and Schedule 1 notes secular equilibrium (note a), ensure the measurement and reporting account for assumed equilibrium. That may affect which parent/progeny labelling applies.

2. Determine licensing and certificate requirements

• If the material or source is radioactive under reg 6-7, identify whether a management licence (possession) and/or use licence applies under the Act. The Regulations set the fee structures and categories for management licences in Schedule 7; ensure the correct category is selected.

• For diagnostic X‑ray equipment listed in Schedule 5, ensure a current certificate of compliance is in place prior to use (reg 12). Pay attention to the expiry periods in Schedule 6: CT scanners and mammographic equipment require annual certification while radiographic and fluoroscopic equipment are on a two‑year cycle (reg 13 and Schedule 6).

3. Prepare application documentation and identity verification

• Produce identity documents consistent with reg 8 and Schedule 2. Unless using a Commonwealth Aviation or Maritime Security Identification Card as allowed by reg 8(2), compile at least one original from each Schedule 2 category (Categories 1-4). Keep originals available for inspection; do not rely on photocopies.

• Prepare the technical and security documentation required under the Act for the specific type of licence or certificate (the Act sets many documentary requirements; the Regulations set numeric and documentary detail).

4. Calculate and pay correct fees

• Compute fees using the fee-unit method. Multiply the number of fee units indicated in regs 14-19 and Schedule 7 by the fee-unit monetary value for the relevant financial year as fixed under the Monetary Units Act 2004 and published by the Treasurer (explanatory details).

• Recognise the two-part fee structure: an application processing component and a licence-term component (regs 14-16). For management licences with multiple sources, aggregate the per-source fee units as required by reg 15(2).

• Plan for renewals: set calendar reminders for renewal windows (use licences, management licences, tester approvals) to avoid lapses and potential enforcement exposure. Renewal fees are set in regs 17-19 and Schedule 7 (reg 18 for management licence renewals).

5. Budget for recurrent testing and certificates

• For CT and mammography units, schedule annual certification testing and budget for annual fees and any rectifications (Schedule 6). For plain radiographic and fluoroscopic equipment, schedule biennial certification.

• Maintain records of certificate issue and expiry dates in a compliance register to support audit and inspection readiness.

6. Observe dose limits and monitor exposure

• Put in place monitoring systems (personal dosimeters, environmental monitoring) that can report doses in time windows consistent with Schedule 4: 12-month and 60-month effective dose windows, lens of the eye limits, skin and extremity limits (Schedule 4 Table A and Table B).

• For pregnant workers, implement the notification and protection arrangement set out in reg 11(1)(c): upon notification, apply the public-exposure uterus limit for the worker’s reproductive organs while other body parts remain subject to occupational limits; document the notification and any work adjustments.

7. Manage sealed sources and D-value evaluations

• For sealed sources, consult Schedule 3 D-values when applying the s 3A activity-ratio test (reg 10). Ensure activity is measured and converted to GBq as Schedule 3 uses GBq for the D-value.

• Where sources might be “high consequence,” assess whether the premises qualify as a “prescribed radiation facility” per reg 9. If so, apply the Act’s facility licensing, security and safety obligations.

8. Prepare security plans and amendment processes

• If an approved security plan exists, ensure any amendments fit within reg 22’s prescribed amendment list for “no material impact” or routine replacement: manufacturer name, serial number, measured activity/date, special form number, date of expiry, etc. If an amendment is material, follow the Act’s requirements for non-prescribed changes and obtain Secretary approval.

9. Use the Secretary’s fee relief mechanisms where appropriate

• If an application is refused or you withdraw before decision, expect a refund of the relevant authority fee component per reg 20(1). Understand which part is refundable: reg 20(2) lists the authority fee components to which refunding applies (example: reg 14(b) for use-licence term fee).

• For processing component relief on use-licence applications, consider applying to the Secretary under reg 21 for a reduction, waiver or refund of the processing component (reg 21). Document grounds and supporting evidence for any discretionary relief request.

10. Maintain record-keeping and audit trails

• Keep records of radionuclide assays, certificates, licence applications, correspondence with the Secretary, identity documents provided, security-plan changes and dosimetry records. These documents will be necessary to demonstrate compliance under the Act and to respond to inspections or enforcement actions.

11. Seek technical and legal support where thresholds are close or ambiguous

• For borderline cases,mixtures near the reg 7 thresholds, parent-progeny equilibrium assumptions, complex sealed-source activity-ratio calculations,obtain radiochemistry/laboratory support and legal advice. The numeric thresholds are precise and miscalculation can produce licensing obligations or compliance failures.

12. Keep fee-unit conversion and legislative updates under review

• Update fee calculations annually to the Treasurer’s published fee-unit value per the Monetary Units Act 2004 and monitor for any future amendments to the Regulations or to the Act that would change thresholds, D-values or procedural requirements.

Following these steps will position licence applicants and holders to meet the administrative and technical obligations the Regulations prescribe and to prepare for enforcement and audit under the Radiation Act 2005.