PUBLIC CONSULTATION ON PROPOSED AMENDMENTS TO THE RADIATION PROTECTION (IONISING RADIATION) REGULATIONS
National Environment Agency (NEA)
- Consultation Period:
- 01 Dec 2022 - 14 Dec 2022
- Status:
- Closed - Summary of Responses
Consultation Outcome
SUMMARY OF RESPONSES TO PUBLIC CONSULTATION ON PROPOSED AMENDMENTS TO THE RADIATION PROTECTION (IONISING RADIATION) REGULATIONS
Issued by the National Environment Agency (NEA)
23 December 2022
1. The National Environment Agency (NEA) conducted a public consultation on proposed amendments to the Radiation Protection (Ionising Radiation) Regulations from 1 to 14 December 2022. At the close of the public consultation, NEA received 55 responses from members of the public and Ionising Radiation (IR) licensees.
2. Overall, respondents were supportive of the proposed amendments by NEA and provided their suggestions and feedback on the proposal. A summary of the key feedback received, and NEA’s responses can be found below. NEA will also be sharing further details on (i) the transition plan to the new IR licensing regime, and (ii) information on any actions required (including specific implementation dates and annual payment procedures) via a separate email in Jan 2023, before implementation of the new regulations.
Licensing and Radiation Worker Registration Regime
3. Most respondents supported streamlining of the licensing regime to reduce administrative work. Nonetheless, there were some concerns about the actual implementation of the changes (i.e. administrative details, application and payment process changes, etc.) particularly for the IR2 licence and R1 registration. There were also suggestions on possible exemption of certain radiation workers from R1 registration.
4. Transition to the new licence regime. NEA will automatically consolidate existing active L3 and L4 licences under the same customer profile in our database into a single IR2 licence and send the new IR2 licence to the customer contact person. Organisations with multiple customer profiles to manage different groups of L3 and L4 licences will receive one IR2 licence for each profile. The validity of the new IR2 licence will be based on the average of the respective L3 and L4 licence expiry dates. For example, if an organisation has an active L3 and L4 licence with expiry dates 30 Aug 2023 and 30 Dec 2023 respectively, the annual payment due date of the new IR2 licence will be on 30 Oct 2023 (i.e. average of 30 Aug and 30 Dec 2023) and its anniversary date will be on 31 Oct. More examples are illustrated in the table below:
Organisation | Active licences held by customer profile | IR2 annual payment due date | IR2 anniversary date |
Organisation 1 |
| 30 Oct 2023 | 31 Oct |
Organisation 2 |
| 29 Sep 2023 | 30 Sep |
Organisation 3 |
| 1 May 2024* | 2 May |
*Note: Even though the anniversary date will be shown as 2 May on the licence, annual payment will not be charged on 1 May 2023 and the next annual payment due will be on 1 May 2024.
5. Subsequently, should there be a need to amend the licence (e.g. add items, amend licence details), licensees will need to submit an IR2 licence amendment in the GoBusiness Licensing Portal. There will be effectively no change in the fees incurred for such amendments as illustrated in the table below:
Amendment to existing IR2 licence | Current fee | New fee in 2023 [no change from current fee] |
(i) Addition of new irradiating apparatus not containing radioactive material | $155 per item [Note: This is equivalent to a new L3 licence for the apparatus.] | $155 per item |
(ii) Addition of irradiating apparatus containing radioactive material | $25 per application [Note: This is equivalent to an L4 licence amendment to add a new radioactive material.] | $25 per application |
(iii) Addition of radioactive material | ||
(iv) Amendment of licence details | $25 per application [Note: This is equivalent to an L3 or L4 licence amendment, e.g. updating of storage location, etc.] | $25 per application |
6. R1 registration for radiation workers. For individuals with existing L5 and L6 licences and R1 registration, NEA will automatically issue each individual with the new regime R1 registration certificate if their licences or registration are active as at the start of the transition period (exact date to be shared separately). If the licences or registration have expired as at the start of the transition period, the individual will not be automatically issued with a R1 certificate under the new regime, and individuals will need to submit a new R1 registration application if they still require the R1 registration. The validity of the new R1 certificate will be based on the average of the respective active old L5, L6 and/or R1. In addition, with the elimination of L5 and L6 licences, individuals will no longer need to amend their licences when there are changes to their employer’s possession licences (e.g. do not need to add or remove irradiating apparatus or radioactive materials into individual licence). For new R1 radiation workers, the responsibility and credentialling will be similar to that of current L5 and L6 licence and R1 certificate holders. The R1 certificate will specify the type of radiation work that the individual is authorised to engage in, as well as specific conditions to ensure that the individual only engages in certain work that is appropriate based on the individual’s qualifications and responsibilities.
7. For the avoidance of doubt, under the new licensing regime, IR2 licence will be held by the organisation, while R1 certificate will be held by the individual. More information on the transition to the new licence regime will be sent separately via email to all licensees and made available on the NEA website in Jan 2023.
8. Exemption of certain radiation workers from registration. NEA intends to work with licensees to identify classes of work that may be suitable for exemption from registration. Licensees may also submit their proposals for exemption of workers with supporting assessments for NEA’s consideration. NEA will provide information to licensees on the channel for such submissions separately in Q1 2023.
Removal of Entitlement for Personal Dose Monitoring Services
9. There were mixed views on the decoupling of personal dose monitoring services from licensing. Some respondents were supportive of the removal of entitlement as there would be more flexibility in the monitoring programme and potentially, the choice of vendor for the monitoring service, while others were concerned about the dose monitoring fees.
10. With the decoupling of personal dose monitoring services from licensing, NEA would like to clarify that there will be no change in the personal dose monitoring subscription provided by NEA’s Radiation Services Branch. However, subscribers will be required to pay for the service separately at the rate of $15.75 per month (inclusive of GST), which is the rate currently charged for non-licensees subscribing to the service. There are currently no other approved personal dose monitoring service providers.
11. With the shift to a performance-oriented requirements for occupational exposure, licensees may propose alternative arrangements for occupational exposure (in place of personal dose monitoring), where appropriate, for NEA’s approval. Licensees may submit proposals supported with detailed assessments to NEA for consideration. NEA will provide information to licensees on the channel for such submissions separately.
Exemption, Clearance, and Radioactive Waste Management
12. Respondents were generally supportive of the exemption, clearance, and radioactive waste management provisions. In view that details of these provisions would only be released later in Q1 2023, there were queries on the clearance criteria for radioactive materials, as well as the application for approval to accumulate radioactive waste at the organisation’s premises. There were also suggestions from licensees on certain applications or devices that could be considered for exemption from licensing.
13. NEA takes guidance from international standards or guidelines on exemption and clearance of irradiating apparatus and radioactive materials, and will adopt the clearance criteria established in International Atomic Energy Agency (IAEA) General Safety Requirement (GSR) Part 3, which includes provisions for clearance of both sealed and unsealed sources. On the approval required to accumulate radioactive waste, NEA does not intend to require such approval for radioactive waste with short-lived isotopes that would be eligible for clearance within a certain period of time (to be defined by NEA) nor disused sources that will be exported shortly after end of use. NEA intends to publish guidance on classification of radioactive waste and will clarify the circumstances under which approval to accumulate and transport radioactive waste must be obtained.
14. NEA notes the feedback on exemption of certain applications or devices from licensing and will carefully consider each suggestion.
Emergency Preparedness and Response
15. Some respondents suggested for NEA to provide (i) guidance and references for the components required under the emergency preparedness and response plan for radiation protection, and (ii) list of approved training providers or organisations providing clean-up service for radiation-related incident. Respondents also suggested that the response plan template could tie in with existing Singapore Civil Defence Force (SCDF)’s template.
16. NEA is currently working with industry experts to develop guidelines for licensees to follow and comply with our requirements (including emergency preparedness and response). NEA will also work closely with relevant agencies (e.g. SCDF, etc.) to streamline the number of documents to be prepared by licensees, where appropriate, and prevent overlaps or conflicts.
Other Works
17. Separately, NEA will be implementing a new service on NEA ePortal called "Customer Profile and Worker Management". The service will enable licensees and radiation workers to manage their customer profiles (e.g. update contact person details) and allow organisations to view information about radiation workers employed under their organisation.
18. NEA is working with industry experts to develop guidelines for the various applications of radiation to provide guidance on meeting regulatory requirements and enhancing radiation safety and security. Subsequently, NEA will also be working with them to develop training and continuous training programmes to improve the competency and radiation safety culture among radiation workers.
Conclusion
19. NEA would like to thank all respondents for their feedback. We will consider all feedback received and incorporate them into the revised regulations where appropriate. Further details on (i) the transition plan to the new IR licensing regime, and (ii) information on any actions required (including specific implementation dates and annual payment procedures), will be shared via a separate email in Jan 2023, before implementation of the new regulations.
20. NEA will separately engage licensees on classes of work that may be suitable for exemption from R1 registration. NEA will, in due course, provide further information and guidelines for the various applications of radiation to provide guidance on meeting regulatory requirements and enhancing radiation safety and security (including emergency preparedness and response).
Detailed Description
Public Consultation on Proposed Amendments to the Radiation Protection (Ionising Radiation) Regulations
Aim
1. The National Environment Agency (NEA) is inviting members of the public to provide feedback on the proposed amendments to the Radiation Protection (Ionising Radiation) Regulations (RP(IR)R). The consultation exercise will take place from 1 to 14 Dec 2022. The proposed amendments to the RP(IR)R will streamline the licensing regime to reduce administrative burden on licensees. The key changes are as follows:
a) Shift away from current prescriptive, practice-based approach to a performance-oriented approach based on exposure situations (i.e. occupational, medical and public exposure);
b) Streamline licensing regime to combine current separate licences required for ionising irradiating apparatus and radioactive materials, and remove licence or registration validity period;
c) Decouple personal dose monitoring services provided by NEA from licence application fees; and
d) Include new provisions for clearance, justifications of practice, management of radioactive waste, emergency preparedness and response and security of radioactive materials
Background
2. The RP(IR)R was first published under Radiation Protection Act in 1974 and amended in 2000 to incorporate requirements of the International Basic Safety Standards (BSS) published by the International Atomic Energy Agency (IAEA) in 1996 which took into account 1990 Recommendations of International Commission on Radiological Protection (ICRP). In 2014, the IAEA published the General Safety Requirements (GSR) Part 3 on “Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards” which superseded the BSS of 1996 and took into account the 2007 Recommendations of the ICRP. NEA is proposing to amend the RP(IR)R to align with international standards and practices, following an earlier industry consultation in July 2018. The proposed changes are consistent with the changes proposed during the 2018 industry consultations.
Proposed Amendments
Regulatory approach
3. NEA proposes to amend the RP(IR)R from a prescriptive, practice-based approach to a performance-oriented approach based on exposure situations (i.e. occupational, medical and public exposure). The IAEA standards for radiation protection has evolved from a practice-based approach to an approach based on exposure, which allows radiological protection to be applied to any situation of radiation exposure, instead of only to specific applications or practices. The IAEA also encourages shifting away from prescriptive requirements towards a more performance-oriented approach. To align with international standards, NEA intends to amend the Regulations from the current practice-based approach (e.g. specific requirements for use of sealed source for medical therapeutic purpose, use of irradiating apparatus for industrial purposes, etc.) to an approach based on exposure (i.e. occupational, medical and public exposure).
4. To effect this change, Parts X to XV of the existing Regulations, which provide requirements for specific practices, will be deleted. They will be replaced by three new Parts on “Occupational exposure”, “Medical exposure” and “Public exposure”, in line with the IAEA Model Regulations. Correspondingly, the provisions under Parts V and VI of the existing Regulations on “Control of radiation exposure” and “Medical and radiological supervision” respectively will be subsumed under the new Part on “Occupational exposure”.
Licensing regime
5. NEA proposes the following changes to streamline the licensing regime: (a) separate licences required for ionising irradiating apparatus and radioactive material will be combined; (b) separate licence types for keeping or possessing for use, and to use, will be merged into a single licence type; (c) multiple licences for apparatus under the charge of the same person at the same site will be consolidated into a single site licence; (d) licence or registration validity period will be removed, i.e. licence will be on life-time basis with an annual recurring fee. These proposed changes will reduce administrative work for licensees (e.g. fewer licences to manage, no need to submit licence renewal applications periodically). With the streamlined licensing regime, for example, a licensee with one apparatus containing radioactive material and three apparatus will have one licence, instead of five separate licences under the existing licensing regime (i.e. one licence for radioactive material, four for apparatus).
6. The proposed new licensing regime will have five licence types instead of the existing nine licence types:
Existing regime | New regime |
L1 – Licence to manufacture, possess for sale or deal in irradiating apparatus | IR1 – Licence to manufacture, possess for sale or deal in irradiating apparatus or radioactive materials |
L2 – Licence to manufacture, possess for sale or deal in radioactive materials | |
L3 – Licence to keep or possess an irradiating apparatus for use (other than sale) | IR2 – Licence to keep, possess for use (other than sale) or use irradiating apparatus or radioactive materials |
L4 – Licence to keep or possess radioactive materials for use (other than sale) | |
L5 – Licence to use irradiating apparatus (other than sale)* | |
L6 – Licence to use, handle and transport radioactive materials (other than sale)* | |
L6A – Licence to handle and transport radioactive materials | IR3 – Licence to handle and transport radioactive materials |
L7 – Licence to import or export a consignment of irradiating apparatus | IR4 – Licence to import or export a consignment of irradiating apparatus |
L8 – Licence to import or export a consignment of radioactive materials | IR5 – Licence to import or export a consignment of radioactive materials, or transit or tranship a consignment of nuclear material |
*Existing L5 and L6 licensees who engage in radiation work will fall under the radiation worker registration regime (see paragraph 9).
7. The above-mentioned new licensing regime will subsequently be accompanied by a new fee structure starting from 2024 to better reflect the effort and costs associated with the different regulatory activities.
8. To provide time for transition and socialising of the changes in the licensing regime, NEA will effect the new licensing regime structure, but keep the fees at the current rates. New fees will only be implemented from 2024. Details on the current licence fees can be found in Annex A.
Radiation worker registration regime
9. In line with the streamlined licensing regime, NEA proposes to amend the radiation worker registration regime by: (a) removing registration period such that renewal would no longer be needed, (b) revising existing renewal fee to an annual recurring fee, and (c) including provisions to allow NEA to exempt from registration certain radiation workers operating radiation sources that present very low radiation risk, i.e. less than one-tenth of the dose limit for radiation workers. Details on the current fees for radiation worker registration can be found in Annex B.
Removal of entitlement for personal dose monitoring services
10. NEA proposes to decouple personal dose monitoring services provided by NEA from licensing to better reflect the corresponding service charges from the regulatory costs. Currently under the RP(IR)R, L5, L6 licensees and radiation workers receive personal dose monitoring services provided by NEA. Taking into consideration that there may be differences in the personal dose monitoring requirements for different radiation workers, NEA intends to remove these provisions to better reflect the service charges. NEA will continue to provide such monitoring services which will be charged separately from licence fees1. Correspondingly, the annual recurring fee for registered radiation workers will be reduced from $105 (existing renewal fee) to $50. More details on the current fees for radiation worker registration can be found in Annex B.
Exemption
11. NEA proposes to align exemption provisions with latest international standards (i.e. IAEA GSR Part 3). The exemption provisions for maximum activities and activity concentrations of radionuclides will be updated to be in line with Schedule I of the IAEA GSR Part 3, and the existing First Schedule of the RP(IR)R will be replaced with Tables I.1 and I.2 of IAEA GSR Part 3.
Clearance
12. NEA proposes to include provisions for clearance of materials from regulatory control and establish clearance values. Radioactive materials undergo radioactive decay over time. Currently, controlled materials may be disposed of or released from regulatory control when the radioactivity decreases to below exemption levels as specified in the First Schedule (i.e. no separate criteria for exemption and clearance). To align with Schedule I of the IAEA GSR Part 3, NEA intends to:
• Include specific provisions for the clearance of materials from regulatory control, and
• Adopt the clearance criteria established in Schedule I of IAEA GSR Part 3.
Justification of practices
13. NEA proposes to include provisions on practices that are deemed to be unjustified. The IAEA encourages member states to ensure that no practice is authorised unless it is justified (i.e. likely to produce sufficient benefits to exposed individuals or society that outweighs the radiation harm that it might cause taking into account social, economic and other relevant factors). In line with Articles 22 and 48 of the IAEA Model Regulations, NEA intends to:
• Include additional practices that are not deemed to be justified, such as (a) practices that result in increased radioactivity in beverages, or other commodity intended for internal intake, and (b) frivolous use of radiation or radioactive substances in commodities/products such as toys, jewellery, adornments, etc. Radioactive substances to be used in unjustified practices will be excluded from exemption under certain general exemption provisions.
• Include provisions that exposure of volunteers as part of biomedical research is deemed to be not justified, unless (a) it has been approved by an institutional review board, and (b) the exposure of research subjects complies with dose constraints that may be specified.
• Include provisions that human imaging using ionising radiation is deemed to be not justified, if it is: (a) performed as a form of art or for publicity purposes, (b) for theft detection purposes, or (c) for detection of concealed objects (unless carried out by the Government or approved by NEA).
Designation of responsibility
14. NEA proposes to include requirements for licensees to designate suitably qualified persons to carry out necessary tasks and actions to fulfil the licensee’s responsibility for radiation protection and safety. To further augment the proposed change in licensing regime mentioned in paragraph 5, NEA intends to include requirements for all IR1 and IR2 licensees to designate and maintain a list of qualified person(s) to be responsible for each apparatus or radioactive material under the licence. In line with Article 18 (paragraph 1) of the IAEA Model Regulations, licensees will bear the prime responsibility for ensuring radiation protection and safety, and must designate suitably qualified persons to carry out actions and tasks related to these responsibilities.
Radioactive waste management
15. NEA proposes to include provisions for management of radioactive waste (i.e. handling, processing, storage and transport of radioactive waste). Currently under the Radiation Protection Act, a person must not dispose of, accumulate or transport any radioactive waste without prior written approval. However, the RP(IR)R does not specify requirements for obtaining such an approval. Moving forward, NEA intends to include provisions for application and granting of approval to accumulate or transport radioactive waste in Singapore2. A fee will also be introduced for the application for approval to accumulate or transport radioactive waste. More details on the fees can be found in Annex B.
16. In line with the respective Articles of the IAEA Model Regulations, NEA also intends to include provisions on waste management, such as:
• Responsibilities associated with management of radioactive waste (Articles 72, 75, 76)
• Control of radioactive waste generation (Article 81)
• Radioactive waste characterisation and classification (Article 82)
• Acceptance criteria for radioactive waste (Article 83)
• Processing of radioactive waste from collection up to treatment (Article 84)
• Conditioning (Article 85)
• Storage of radioactive waste (Article 86)
• Management of disused radioactive sources (Article 87)
• Discharge of radioactive materials to environment (Article 89)
• Requirements for radioactive waste management facilities (Articles 92, 93)
Emergency preparedness and response
17. NEA proposes to include requirements for emergency preparedness and response to impose responsibility on licensees to ensure that provisions are made for proper response in the event of an incident or accident to protect people and the environment. In line with Articles 99 to 102 of the IAEA Model Regulations, NEA intends to include provisions for the following:
• Submission of emergency response plans (where there is any risk of an emergency affecting employees, workers or members of the public)
• Responsibilities of licensees
• Implementation of intervention
• Protection of emergency workers
Security of radioactive materials
18. NEA proposes to include provisions for ensuring security of radioactive materials. Currently under the RP(IR)R, radioactive materials must be stored in a manner as to prevent unauthorised access. However, such requirements need to be strengthened in view of the sensitive nature of radioactive materials and there is a need to accord a higher level of importance to the security of radioactive materials. As such, NEA intends to include general provisions for ensuring the security of radioactive materials:
• Security of facilities storing radioactive materials
• Security of radioactive materials during transport
• Duty to report breach of security measures
Screening of individuals handling high risk radioactive materials
19. NEA proposes to include provisions to enable NEA to reject an application, if: (a) the applicant is not a fit or proper person to hold the licence or to be registered as a radiation worker, (b) it is not in the public interest to do so, or (c) the grant of the licence or registration of the applicant as a radiation worker poses a threat to public order or the national security of Singapore. In determining whether an applicant is a fit or proper person, NEA may take into consideration that the applicant has been convicted of an offence under the Radiation Protection Act or its Regulations, or any other offence involving fraud, dishonesty or moral turpitude.
20. These provisions are intended to expressly allow NEA to refuse the grant of the licence or registration as a radiation worker, on the basis that it is not in the public interest for the applicant to hold the licence or be registered as a radiation worker, or that it may pose a threat to public order or the national security of Singapore. Similar provisions to expressly allow NEA to suspend or cancel an existing licence or registration if any of the criteria mentioned in paragraph 19 is met, are also intended to be included. NEA will exercise discretion in applying these criteria to assess the suitability of the applicant to hold the licence or be registered as a radiation worker.
Sale and supply of irradiating apparatus and radioactive materials
21. NEA proposes to include requirements for sale and supply of irradiating apparatus and radioactive materials. Currently, requirements on sale and supply of irradiating apparatus and radioactive materials (e.g. only allowed to sell to persons authorised to possess such apparatus or radioactive materials) are only stipulated in licence conditions. Moving forward, NEA intends to regularise these requirements in the Regulations to facilitate enforcement in the event of non-compliance.
Educational institutions in possession of exempted radioactive substances
22. NEA proposes to remove requirements for educational institutions to submit the name of the teacher designated to be responsible for safe storage and use of the exempted radioactive substances. As teacher portfolios may change relatively frequently with respect to the life of the radioactive material, NEA intends to amend this provision to instead require the educational institution to ensure that a competent staff has been designated to take full responsibility for the safe and secure storage and use of such exempted radioactive substances. This ensures that there is a competent staff designated with the responsibility for safety and security at all times, and not just at the time of submission. For the avoidance of doubt, these educational institutions would still be required to submit the details of the exempted radioactive substances to NEA, as is the current practice.
Dose limits and weighting factors
23. NEA proposes to update the dose limits and weighting factors in the Second Schedule of the RP(IR)R to be in line with the IAEA GSR Part 3. NEA intends to align: (a) the dose limits in RP(IR)R with Schedule III (paragraph III.1 to III.3) of the IAEA GSR Part 3, and (b) the tissue weighting factors in RP(IR)R with the corresponding values under the definition of “tissue weighting factor, wT” in IAEA GSR Part 3.
Implementation period
24. The proposed amendments to the RP(IR)R are intended to take effect in early 2023. This will tie in with the onboarding of the new Information Technology (IT) systems with added functionalities to augment the streamlined licensing regime, e.g. customer profile management, radiation worker management, etc. for licensees.
Providing Feedback
25. NEA invites members of the public to share your views on the proposed amendments to the Radiation Protection (Ionising Radiation) Regulations to better protect our people and environment from harmful effects of radiation. You may do so by 14 Dec 2022 by clicking the button at the bottom of the page.
26. To ensure that the consultation is productive and focused, respondents are requested to observe the following guidelines when providing their feedback:
• Identify yourself as well as the organisation you represent (if any) so that we may follow up with you to clarify any issues, if necessary.
• Be clear and concise in your comments.
• Focus your comments on the proposal and how it can be improved.
• As far as possible, substantiate your points with illustrations, examples, data or alternative suggestions.