09 February 2017
Notes of SRP meetings on Implementation of BSS: Ionising Radiations Regulations (IRR) and Other Regulations held on:
Thursday 19th January, Royal Institution, London
Thursday 26th January, Manchester Conference Centre, Manchester
Thursday 9th February, Kelvin Conference Centre, Glasgow
Presentations are at the end of the report.
Notwithstanding UK’s EU referendum results, the EURATOM Basic Safety Standards (BSS) Directive 2013/59 will have to be transposed into UK legislation by 6th February 2018. To help prepare for the legislative changes these meetings were hosted by SRP with Keynote speakers from HSE focussing on the new Ionising Radiations Regulations (IRR17) and other regulators.
These notes have been prepared to summarise the discussions at this series of meetings. They have been prepared by members of the SRP’s Basic Safety Standards Directive (2013) Working Group (BSSD(2013)WG)with input from HSE. These notes reflect the views of the SRP BSSD(2013)WG and are not intended as feedback in the consultation for the new IRRs now underway.
2 Ionising Radiations Regulations
The IRR17 will be implemented on 1 January 2018
The consultation period runs from 7th Feb 2017 to 2nd April 2017. There is an HSE web link for consultation documents: http://www.hse.gov.uk/consult/condocs/cd282.htm. For clarity, changes from IRR (1999) are highlighted in bold text in the draft IRR (2017). The revised ACOP is included within this consultation. Everything is available for download. There is a summary document (ConDoc) which gives the high-level changes to the IRR.
Revised Guidance is not included, but will be consulted via stakeholder working groups; and main Guidance (as per L121) will be implemented to same timescales as IRR and ACOP. Other HSE guidance documents might need to be revised to later timescales. Guidance documents are targeted for completion in October 2017 and will be published to coincide with the regulations coming in to force. A working group comprising volunteers from SRP, IPEM and AURPO is to be formed to assist with the drafting of the guidance.
HSE emphasised the need for constructive comments. If there is something that is felt to be incorrect then correspondents should state that AND give what they believe to be the correct information which contains as much information as possible on costs, such as an assessment of the time taken to undertake something and who would carry this out i.e. what is the cost of their time . This will allow for HSE to check, verify and challenge any figures given. Comments can be sent in on paper as well. It was reinforced that the cost modelling needs to be studied and challenged if incorrect. It will take a valid financial reason or savings to make a change to the regulations.
HSE emphasised that ministers views could impact on the way that BSSD is transposed, and this is something to bear in mind.
2.3 Graded Approach to Notification, Registration and Licensing
One of the more significant changes will be to adopt a graded approach – Notification, Registration and Licensing. Current registrations under IRR99 will not be carried forward to 2018 under IRR17; therefore employers of all relevant practices (for which the definition remains the same as in IRR99) will need to submit under new regime by 6 February 2018. Online registration arrangements are planned to be available from autumn 2017 so that employers can notify, register or apply for a licence in advance and to enable completion by 6th February 2018. (Template registration forms are not yet available.)
It is anticipated that Registrations would need to be re-submitted every five years; and Licenses re-submitted every one year: this is subject to consultation. It was emphasised that the employer has the legal duty to submit notifications, not the RPA.
The notification, registration and licensing scheme is employer based NOT site based. This is particularly relevant, for example, to large NHS trusts or veterinary practices. Only one notification is required per employer’s practice, even if the practice is undertaken at multiple locations. This should help minimise the notifications required: e.g. for small users, etc. It should be noted that an employer may need one licence for a particular practice and may also need notifications or registrations for others.
Notification of radon levels exceeding national reference levels will need to be submitted notwithstanding any prospective remediation.
One person questioned if is it feasible to share Registration database details with other agencies? (e.g. ‘blue light’ agencies). Not considered to be practicable.
Licensing is required based on assessed ‘high risk’ activities: e.g. would apply to linear accelerators, even if operated in a low/nil occupancy facility, due to potential for incurring high doses. It has not yet been decided if Licenses will be issued with specific License Conditions: this may be developed over time. However it is thought beneficial for planning work to retain the seven-day prior notification period (from client to employer) for intended use of industrial radiography units; so this might be retained as a license condition. It is not clear whether Licenses will be subject to withdrawal by HSE or how this could this be implemented if no Conditions are issued with a License?
Question was asked “Where does RPA advice fit into licensing?” The HSE answer was that it must be done for licenses and is not firmly required for registrations. HSE emphasised that the guidance for when to consult an RPA that is currently in the regulations (Schedule 5) should be followed re consulting an RPA and that when we consult an RPA, need to show that the advice was followed.
HASS will require HSE licencing. Handheld XRF will require registration
Some benchmarking has been done against what other member states are doing to implement the BSSD. HSE said that each of the member states have a unique set of regulations and what another country is doing would not necessarily be valid for our regulatory regime in the UK.
There will be a fee associated with registration and licensing, the amount has not been set yet. HSE have considered various costing options associated with introducing and operation of this revised approach, which have been included within the overall Impact Assessment for BSS. There was vocal concern that charging for schools would be very detrimental. Schools can ill afford new charges (however small) and this may have the unintended consequence of driving them away from teaching science and the benefits and risk of radiation. It was noted that an approach through the Education Minister may be helpful and also that SRP are lobbying for this charge to be waived for schools.
The revised approach to notification, registration and licensing will enable HSE to better understand the levels of risks with employers and target inspections appropriately.
Nuclear Site Licenses will not need to submit separate Licenses, unless a practice is out of scope of the Nuclear Site License – in which case separate Licenses will be required. Notification, registration and licensing requirements for MOD sites are still in discussion between HSE and MOD.
Approved Dosimetry Services may become Recognised Dosimetry Services. The HSE does not plan to reassess the existing ADS as part of the BSSD implementation process.
Nationality will not be added to dose records as there is no overall health and safety benefit to this and adding a field to the database does cost money. With respect to unique ID HSE feels that using the National Insurance numbers (and stakeholders say that other qualifiers are used such as date of birth) already meets the BSSD requirement for this. NO change
Record retention moving from the current 50-year requirement to 30 years set out in BSSD.
A question was asked by an attendee, “How will cyber security of data be maintained?” The answer was to follow our current cyber rules and procedures governing personal data.
2.4.2 Tissue weighting factors, dose coefficients and ICRP models
Revised dose coefficients for radon might be implemented by 1/1/18 if ICRP publish before then.
The process for implementing other forthcoming ICRP revisions to dose coefficients and models (for internal dosimetry) is still undecided; although it is doubtful that this would require any further/later revisions to regulations.
It is noted that ICRP technical recommendations – if not directly incorporated into BSS – do not have any mandatory legal basis; and, therefore, it might be possible for regulators and ADS to exercise discretion and flexibility over whether, when and how to adopt into practice.
2.4.3 Eye dose
PHE have undertaken research on the impact of the of revised dose limit of the lens of the eye. In the medical sector it is anticipated that most doses can be reduced to < 20mSv per year and further improvements can be made to reduce annual doses to less than 15mSv by the adoption of modern equipment and engineering controls (shielding).
There was concern that future practices may be more dose intensive and the possibility of 5-yearly dose averaging was raised. In line with what is set out in the BSSD current practice this will be permitted according to conditions set by the regulator; however, HSE would consider a pragmatic and justified case for urgent requests to permit dose averaging. It was noted that the 5 year limit is a limit and any increase over the annual limit would have to be compensated for in other years.
The use of collar dosemeters instead of specific eye-lens dosemeters as a means to measure eye-lens dose is currently a matter of discussion between HSE and operators.
Whether the eye-lens dosemeter should be worn continually or just for specific operations with elevated risk of exposure to eye was discussed. This is not an issue for Non-classified workers, but employers are required to fully monitor doses for Classified workers. So where operations involve significant exposure to the eye monitoring will be required, where there is insignificant exposure monitoring will not be required. This is considered to be a similar consideration to the issue of extremity dosimetry.
2.5 Outside worker
A question was asked about recording outside worker exposure when entering Supervised Areas. HSE response was that Supervised Area calculations should already cover outside workers entering them.
Outside workers now include entry into Supervised Areas. HSE is asking for financial costs input for implementing this. Some of the RPA attendees stated that the costs for them would be in the millions. HSE asked for additional documentation which would support this assumption as set out in the new IRRs.
Non-classified OWs will not require passbooks; the HSE’s intention is that changes to regulations will be simply to update terminology, and will not affect any practical changes to current regulations for OWs and co-operation between employers.
The potential benefits of a digital passbook system was mooted, but not likely to be practicable in the foreseeable future; however, it was suggested that regulations should be written so as not to preclude any such future developments.
2.6 Qualified Persons/Expert status
A question was asked about what is happening to the Qualified Person for Instruments that is currently in the IRR99? HSE replied that it was still being developed and they didn’t know what would be the final decision.
Currently SRP, IPEM and AURPO are reviewing the structure and requirements for developing a simplified approach to validating Qualified Persons (currently RPA and RWA through RPA200) and the changes needed to implement Medical Physicists Expert (MPE) status. Current thinking is that RPA200 will be superceded by a Radiation Protection Council overseen by SRP, IPEM and AURPO. There are likely to be simplified requirements for expert status in order to lower the burden, but not to reduce standards.. Changes to RPA/RPA2000 – Radiation Protection Council is to be established?? HSE had an open discussion about the Chartered status of the SRP and why that wasn’t being used?
There is no change in the regulation that calls for consulting Qualified Eexperts (eg RPAs). IRR17 will still call for the consultation of a suitable appointed RPA under appropriate circumstances.
2.7 IRR99 Reg 32 - Equipment used for medical exposure
The appropriate regulatory authority for this requirement is currently under discussion between HSE and Dept of Health.
HSE stated that there is an effort being made to standardise terminology across the various new regulations there is an effort to modernise the language used in the IRR during this revision, such as gender specific references.
2.8.2 Radiation employer
“Radiation Employer” will be replaced with “Employer” in IRR17. There was some concern that there should be clarity on the different/special responsibilities for a radiation employer, but the regulations actually apply to all employers.
2.9 Other issues
HSE will maintain their own threshold tables as what is at an Out of Scope level under EPR could still give someone a substantial dose in some scenarios.
New requirement from HSE – record and analyse all events that trigger the use of contingency plans
There was some discussion on the definitions of “reasonably foreseeable” and “likely to”. Jane stated that perhaps the SRP should put out guidance on definition in the regulations.
“Unforeseen event” is NOT coming into the IRR17 – staying in REPPIR
“Significant events” require contingency plans. HSE urged a pragmatic approach be followed in drafting contingency plans – act reasonably. It was stated by the HSE that the Employer should have a definition of what constitutes a “radiation accident”.
Public dose estimates should be based on normal operating conditions – not to consider upset conditions.
3 Other regulations
3.2 Radioactive substances regulations
Consultation exercise for revisions to EPR2016 will commence in May 2017, for eight weeks. Revised regulations will take effect on 6th Feb 2018.
The current Public Dose limit of 1 mSv/year with a dose constraint of 0.3 mSv/year. There was a question posed about the lifetime dose to the public which has been referred to HSE. This question was posed referencing the RIFE Reports which state that some members of the public are receiving 0.38 mSv/year from Polonium 210 (according to the person who asked the question). It was also asked if public should really be the “representative group”.
HASS will be moving to IAEA D values. Some sources will now fall under the regulations but more will drop out of the regulations with the change to the D values. Additionally, sources will now be allowed to drop from the regulations once they have decayed below the lower value.
The new BSS values for ‘out of scope’ levels to be adopted; but it might be feasible to retain current values in certain circumstances if there is clear justification.
Caesium 137 and Carbon 14 values will not be lowered to the proposed values given in the BSSD in the UK.
Changes to reference values by are largely administrative.
Orphan sources will be re-defined to include any source; but not expected to have any material impact.
3.3 CDG regulations
These will have some overlap with IRR17 and REPPIR. It was stated that carriers of radioactive materials should make notification to HSE.
3.4 Update on Regulatory Reforms in Scotland (Glasgow meeting only)
An integrated authorising framework is being established, which will cover radioactive substances, waste, water & pollution regulations.
The consultation period on this framework is from 12th January 2017 to 12th April 2017; with a workshop to be run on 7th March 2017. See link https://consult.scotland.gov.uk/sepa/integrated-authorisation-framework/
Thank you to the speakers and contributors to these meeting.
We are indebted to members of HSE for contributing to these notes.
Chris Perks, Jerry Anderson and Gareth Roberts
SRP BSSD 2013 Working Group
Welcome and Introduction - SRP Working Group, Roger Collison, Babcock International and Mary Allan, AWE
SRP Support and Response - SRP Working Group, Roger Collison, Babcock International and Mary Allan, AWE