Manatū Hauora – the Ministry of Health’s Office of Radiation Safety (ORS) administers the Radiation Safety Act 2016 and the Radiation Safety Regulations 2016.
On 8 May 2023, the Government changed the Radiation Safety Regulations 2016 (the Regulations). The changes apply from 28 June 2023.
The changes are established by the Radiation Safety Amendment Regulations 2023. The changes will be made to the Regulations on 28 June 2023 and the updated regulations will be available shortly after this date.
The changes are summarised on this page:
- New radiation safety fees from 28 June 2023
- Changes to compliance monitoring categories from 28 June 2023
- Introduction of registration and record-keeping requirements for irradiating apparatus used for X-ray fluorescence and X-ray diffraction (XRFs and XRDs) from 28 June 2023
- Clarification to the conditions that apply to the exemption from licencing for XRFs and XRDs
- Reduction to the scope of the activities that registered veterinarians can perform without having to obtain a use licence
- Resources
The changes follow ORS’ 2021 review of the fees paid under the Regulations. The review found that the fees did not fully recover the costs of administering the Act.
Public consultation on the changes was conducted in early 2022 and the documents used for the consultation are still available at Review of Radiation Safety Fees and Regulations. The consultation document provides a report on the 2021 fees review. An independent report by PricewaterhouseCoopers New Zealand on the method for calculating the fee changes is also provided. The consultation document also outlines the other changes to the Regulations.
Subject to the requirements of the Official Information Act 1982, the submissions received during the public consultation and the decision-making documents used to amend the Regulations will be made public. Further information updates and links will be made available on this webpage.
View the cost recovery impact statement (CRIS) used by decision-makers to evaluate the impact of the changes:
If you have specific queries about the changes to the Regulations, you can contact us by email at RadiationSafetyFees&[email protected].
New radiation safety fees from 28 June 2023
Radiation safety fees payable from 28 June 2023 are set out in clauses 7 to 13 and Schedule 2 of the Radiation Safety Amendment Regulations 2023.
The fees are payable for applications for source licence, use licences and consents received on or after 28 June 2023.
Information on the reason for these changes is available in the public consultation document on the changes (section 1 to section 3):
The new fees payable are set out with the information for each type of application:
- Source licences and fees for medical or dental purposes
- Source licences and fees for non-medical and veterinary purposes
- Use licences
- Consents to import or export radioactive material
Changes to compliance monitoring categories from 28 June 2023
Changes to compliance monitoring categories from 28 June 2023 are set out in clauses 7, 8, 9, 12, and Schedule 2 of the Radiation Safety Amendment Regulations 2023.
Routine compliance monitoring will continue to be scheduled by the Director for Radiation Safety and conducted by enforcement officers using routine compliance monitoring visits (on-site inspections) in most cases.
For existing source licence holders, your new compliance monitoring category code will be indicated to you when your source licence is next renewed. Up until your source licence is renewed, the inspection period that applied when your source licence was granted (or last renewed) will remain in force.
In most situations, routine compliance monitoring will be scheduled at a level that is identical to the inspection periods that have been in place since 2016.
However, there are some changes to the compliance monitoring categories that affect the scheduling of routine compliance monitoring visits and the fees payable for a source licence.
The medical diagnosis compliance monitoring category with an inspection period of 2 years has been amended so that the category now excludes any radiation practice or activity involving radioactive material. This means that places or locations that are authorised by a source licence in this category may have the compliance monitoring category re-determined at the next renewal of the source licence. Where two or more compliance monitoring categories now apply to the radiation practices or activities at the same location, sub-locations will need to be determined in accordance with regulation 16(4) so that the correct renewal fee can be calculated. In some situations, additional compliance monitoring will be scheduled.
The medical diagnosis compliance monitoring category with an inspection period of 4 years has been amended so that it now explicitly excludes interventional cardiology. This category retains the existing exclusions of interventional radiology, computed tomography, and radioactive material. The level of compliance monitoring scheduled for this category has not changed.
There will be lower levels of routine compliance monitoring scheduled for locations or places that are authorised to manage and control:
- dental cone beam computed tomography (CBCT) equipment
- industrial radiography X-ray equipment (only).
There will be higher levels of routine compliance monitoring scheduled for locations or places that are authorised to manage and control:
- fixed nuclear gauges (industrial gauges)
- irradiating apparatus used for human imaging for non-medical purposes
- particle accelerators used for non-medical purposes (eg, large scale security inspections)
- pulse generated portable security inspection systems.
The purposes of compliance monitoring will remain the same.
The principal objective of routine compliance monitoring is to provide the Director with a high level of assurance that source licence holders are meeting the radiation safety requirements at the locations or places authorised by the source licence. The radiation safety requirements are defined in section 5 (Interpretation) of the Radiation Safety Act 2016 (the Act).
Routine compliance monitoring for source licence holders is also scheduled to monitor source licence holders’ compliance with New Zealand’s international obligations referred to in section 3(b) of the Act.
Please note that scheduling information on routine compliance monitoring does not prevent the Director for Radiation Safety from imposing higher or lower levels of compliance monitoring as a condition of a source licence under sections 19(2) and (3) of the Act.
Please note that scheduling information on routine compliance monitoring does not prevent unannounced compliance monitoring for the purposes of monitoring compliance with the radiation safety requirements.
Information on the reason for these changes is available in the public consultation document on the changes (section 2.3 – 2.4, pg 19 – 25).
The routine compliance monitoring that will be scheduled for new source licence and renewal of source licences from 28 June 2023 is set out on Compliance monitoring for radiation safety.
Introduction of registration and record-keeping requirements for irradiating apparatus used for X-ray fluorescence and X-ray diffraction (XRFs and XRDs) from 28 June 2023
Changes to the exemption for dealing with irradiating apparatus used for X-ray fluorescence (XRFs) or X-ray diffraction (XRDs) are set out in regulation 13 of the Regulations. The changes to regulation 13 are set out in clause 6 of the of the Radiation Safety Amendment Regulations 2023.
From 28 June 2023, a person who has management or control of an XRF or an XRD must register the apparatus in accordance with section 31 of the Radiation Safety Act (the Act).
Registration can be done by sending a completed registration form to the email address on the registration form. The registration requirements also mean that a ‘change notification’ form must be completed when there is a:
- change of location of XRFs or XRDs
- change of possession of XRFs or XRDs
- disposal or removal from New Zealand of XRFs or XRDs.
A registration form, a change notification form, and further information on registration is available:
Information on the reasons for these changes is available in the public consultation document on the changes (section 4.1, pg 32).
Clarification to the conditions that apply to the exemption from licencing for XRFs and XRDs
Changes to the exemption for dealing with irradiating apparatus used for X-ray fluorescence (XRFs) or X-ray diffraction (XRDs) are set out in regulation 13 of the Regulations. The changes to regulation 13 are set out in clause 6 of the of the Radiation Safety Amendment Regulations 2023.
The conditions that apply to the exemption from licencing have been clarified to ensure that exempt irradiating apparatus must be completely and permanently enclosed to prevent access of any part of the body to the primary beam while the primary beam is activated.
This change is a technical clarification only and does not introduce or remove requirements.
Reduction to the scope of the activities that registered veterinarians can perform without having to obtain a use licence
The reduction to the scope of the activities that registered veterinarians can perform without having to obtain a use licence is set out in clause 16 of the Radiation Safety Amendment Regulations 2023.
The changes clarify that the authorisation provided by Schedule 3 of the Radiation Safety Regulations 2016 (Schedule 3) is limited to using irradiating apparatus in general radiography for veterinary diagnostic purposes.
The term ‘diagnostic’ means that the use of irradiating apparatus for interventional procedures or for treatment is not included in the authorisation provided by Schedule 3.
The term ‘general radiography’ means that the use of apparatus capable of computed tomography is not included in the authorisation provided by Schedule 3. This is because apparatus capable of computed tomography is not generally used (day-to-day) in veterinary radiography.
Registered veterinarians using irradiating apparatus for interventional procedures, treatment, or that utilises computed tomography, will need to either obtain a use licence or use the apparatus in one of the other conditional situations that can be authorised under the Radiation Safety Act 2016. Information on applying for a use licence is available on the Ministry’s website:
Information on the reason for this change is available in the public consultation document on the changes (section 4.2, pg 34).
Resources
The Radiation Safety Regulations 2016, came into force in 2017.
The Radiation Safety Act 2016 came into force at the same time.
More information on the public consultation that informed the Regulations as introduced in 2016 can be found on the Ministry of Health’s Proposed Radiation Safety Regulations consultation document.