Implementation of BSS to Radioactive Substances Regulations - Join the Debate! (8th December)

08 December 2016

Notes of SRP One Day Meeting

Implementation of BSS to Radioactive Substances Regulations – Join the Debate!

Held on Thursday 8th December 2016, British Dental Association, London


These notes have been prepared to summarise the presentations (available below) and discussions of this meeting.  It is intended that members will further engage in the debate by posting comments in the Forums (this is member access only and you will need to be logged into MySRP or the Forums).

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 this one-day meeting looked at the implementation of the BSS with respect to the Radioactive Substances Regulations.

Following an introduction which included a summary of the recent questionnaire undertaken by SRP and some comments on devolved issues, there were two key sessions each followed by a discussion forum.  Feedback from the discussion for were presented after both sessions.

Session 1: Welcome and Introduction

  1. Introduction

BEIS are open to suggestions regarding changes to existing RSR but need justification and impact assessments to be provided. In line with government policy there will be no ‘gold plating’ and it is unlikely that changes not required by the BSS or that affect only a few employers/sites will be made.

The strategy for implementing the 2013 BSSD is to maintain the existing architecture of legislation, being pragmatic about the changes, and having more continuity than change (evolution not revolution). The new regulations are being drafted now, but ministerial permission is required to release the draft and any associate guidance. From the meetings that have been held to date, it appears that ACoP and guidance will be provided for IRR18 and REPPIR. [Outside the meeting, we note that the Department of Health has indicated that it intends to provide guidance for the  new IRMER.]

  1. Review of Radioactive Substances Regulations Questionnaire

A summary of the results of the SRP on-line survey including was reported.  This included responses received directly via email and other comments – around 80 individual responses in total. Responses were from RWAs and RPAs and included those outside SRP. The main points were:

  • considerable support for keeping and updating guidance;
  • development of out of scope values for liquids (and gases in the medical sector);
  • changes to the EPR Permit,  which at present includes the specific waste disposal site rather than stating any permitted waste disposal site.

1.3 Devolved Issues

In Scotland it was hoped to complete general regulatory regime reform by 6 February 2018 to bring all pollutants together (cf EPR?). But this is very unlikely to be achieved. As a result, the BSSD will be implemented in a similar manner to rest of UK by updating individual pieces of legislation. These interim arrangements are likely to be limited to those changes required by the BSS with other changes to improve the legislation being made at a later date as part of the general reform. Scotland is expecting its draft interim regulations to be available in early 2017 with stakeholder meetings being held to discuss both the interim regulations and longer term reform.

It is anticipated that the interim arrangements to the RSA will match the changes to EPR in England and Wales. The interim arrangements would require changes to primary legislation, but some of the BSS requirements would be implemented via Scottish Government instructions directly to the regulators.

Session 2: Changes to the Radioactive Substances regulations

2.1 The graded approach (i.e. tiers of regulatory control)

The BSSD requires a graded approach commensurate with the hazard posed. In the current regime, a bespoke permit is considered equivalent to ‘licencing’ and a standard permit is equivalent to ‘registration’. EAs do not intend to introduce a requirement for notification for exempt practices [these will be captured for the purposes of BSSD by notification under IRR18]. For the most part there will be no change, however, current regulations do not cover consumer goods (or the import of) so some changes will be needed for that. With regard to the ‘authorisation procedure’ in the BSSD, to meet the requirements that are additional to those for EPR, information will be included in the HSE system, e.g. occupational doses for licenced practices. There are also no changes required with regard to inspection and enforcement.

In some instances, EA has required notification of specific practices, this position would be maintained (so EA retain the option to require notification, but it won’t be a general requirement).

2.2 Radioactive sealed sources

There are some changes to the activities over which sources are classified as HASS. Most are higher than before, but some, notably Am-241, are lower. It is expected that this will result in a reduction of around 25% in the number of HASS sources, for example, in Scotland. The most significant change is that sources will cease to be HASS once their activity has decayed below the relevant level (as opposed to current system where sources remain HASS until they are disposed of). This is likely to have the most impact for sources with relatively short half-lives, such as Ir-192.  There will be no requirement to report annually, although requirements for financial provisions for disposal and security arrangements remain.

There are new requirements in BSSD for other sources – but these will not require any change to UK regulations. The orphan source definition now includes all sources, both sealed and unsealed, and there is a new requirement for metal recycling facilities to report orphan sources if they have smelt or damaged them such that metal has become contaminated. The new regulations will allow prosecution if reporting doesn’t happen. There is a general requirement on governments to raise awareness regarding orphan sources and ensure technical advice is always available (via EA helpline). There are likely to be no practical changes regarding orphan sources, the new regulations will just give enforcement agencies wider brief more formally.

2.3 Radioactive waste clearance and exemption

It is likely that the current framework for exemption and out of scope will continue. Although values are given, there is some scope for adopting different values if these can be justified. Most values will be lifted from BSSD but some, notably for Cs-137 and C-14, will be kept as the existing value.

The definition of NORM and NORM practices is wider in the BSSD and it distinguishes between practices where NORM is used for its radioactive properties and other uses. The UK is likely to include geothermal energy production in its list of practices. There are some differences between the exempt/out of scope values, with most being higher in the BSSD – one exception is K-40 which is currently completely out of scope but given an in scope value of 10 Bq/g in the BSSD.

There was some discussion about having out of scope values for aqueous liquids in 2011 (for EPR Exemption Orders) but was felt to be too difficult as it was too dependent on the individual discharge. There is currently a case being made to include an out of scope level in new regulations.

The intention was to update guidance but that this had been blocked up to now by government policy. However, the EPR is currently being reviewed for other reasons and updated regulations (EPR17) are being introduced early in 2017 for which new guidance will be required.

Call to action:  Please register your interest in out of scope levels for aqueous liquids with EA/SEPA.

Session 3: Changes to the Radioactive Substances regulations.

3.1 Reference levels for public exposure and Dose constraints

Dose constraints are not new and apply to planned exposure situations. Reference levels are new and apply to emergency and existing exposure situations. Both are intended to ensure doses from all situations are optimised, and are not limits – i.e. there is no automatic regulatory enforcement action if constraints or reference levels are exceeded.

BSSD states that Reference Levels should be set at values where it is inappropriate to allow the situation to persist. Values of between 1 and 20 mSv per year are given for existing situations and between 20 and 100 mSv per year (or as an acute dose) for emergency situations. Reference Levels may change with time for the same situation – for example as an emergency moves from the emergency through the recovery phase to become an existing exposure situation.

PHE have been looking at Reference Levels along with the existing system of Emergency Reference Levels (ERLs) which are for immediate action, and are suggesting two new terms:

  • Dose Guideline for Emergency Exposure situations (DGEM) – purpose is to keep individual doses to an acceptable level during the response phase, upper level only will be specified as 100 mSv.
  • Dose Guideline for Existing Exposure situation (DGEX) – likely to be consistent with existing values for contaminated land, i.e. 3mSv per year, but some flexibility to allow for dose optimisation (for example, considering harm caused by individuals having to leave their homes).

Implementation of Reference Level requirements will need new regulations to empower the Secretary of State to be able to set appropriate Reference Levels.

Dose constraints are an upper bound for optimisation of controlled sources. The 2013 BSSD has a slightly different definition to 1996 BSSD (and therefore current RSA and EPR). New values are likely to be included in regulations as: 0.3mSv per year per source and 0.5mSv per year per site.

The dose constraint proposed by PHE of 0.15mSv per year for new practices is an advisory statement and not likely to be included in new legislation. Its basis is that it is likely that dose would be optimised to a greater extent for completely new sources, but that, in practice, new sources are often installed/used on existing sites and there are lots of other confounding factors.

3.2 Existing exposure situations/contaminated land

Existing exposure situations are defined as: contaminated land; areas contaminated during the recovery phase of an emergency situation; and contaminated commodities.

For contaminated land, the current arrangements are consistent with the BSSD approach and likely to be acceptable. For contaminated areas, new legislation supported by guidance is likely to be required to allow the Secretary of State (probably) to set appropriate levels. Further consideration will be required regarding the ongoing control of such areas, including control of access.

The UK will need to establish methods for recognising existing exposure situations where intervention is required, e.g. those where the annual dose is > 3mSv/yr. It is likely that this will be done under the current contaminated land arrangements.

Call to action: is 3mSv/year an appropriate level for contaminated land?

4 Discussion Forum Feedback

Consistency and Harmonisation in legislation

  • Could we please have some clarity that the licencing arrangements will be the same across the UK and across the different sets of legislation?
  • Need consistency between exemption criteria across regs and UK
  • Is commonality in notification/registration/licencing forms from HSE/EAs possible?
  • Have the regulators considered creating a new single enforcement authority for the single Directive? The concept of one ‘registration database’ had been muted early in the proceedings and, although everyone agreed, it would be a good idea, it is unlikely to happen. The current regulatory framework in the UK is too complicated to unravel (particularly in the time available).
  • Could we please have consistency (risk based) between general RSR out of scope levels and NIA de-licencing levels?
    Across current regulations we have:
    • a dose constraint of 0.3mSv/year for new sources,
    • 3mSv/year for contaminated land,
    • > 3mSv/year level for radon remediation I think], and
    • designation of classified person at 6mSv/year (potential!).
  • Should the level for contaminated land level be 0.3mSv/yr.  It would be good to get a consistent view of what level of dose is ‘significant’.
  • Consistency of risk between IRR and EPR. An example whereby an individual cleaning a tank that has held tritiated water can do so with few precautions necessary to restrict their exposure, but any small amounts of waste water that they produce must be disposed of to a permitted waste facility – water was being sent to be incinerated (very costly) from Hinkley C as that was the only method of disposal available!
  • There was concern that some undertakings (eg hospitals) would have to have 3 licences under the new regulations – EPR, IRR and new ARSAC (actually 2 licences, one for employer and one for individual practitioner). It was considered unlikely (but desirable) that the regulators could at least use the same forms – even if they needed to be completed multiple times of different systems.
  • Is there the possibility of a ‘Lead Regulator’.  Concern that ‘driving across the border’ might lead to trouble.
  • Please keep terminology simple and consistent between the various regulations.

Reference levels

  • Different levels were needed for different situations where the level of control or availability of dose reduction measures were available. Impacts on individuals, e.g. major disruption to lifestyle, also had to be taken into account for existing situations arising from emergencies. PHE will continue to provide guidance for the ‘grey line’ between emergency and existing situations.
  • Effective dose is used for Reference Levels for ease of comparison – although thyroid equivalent doses are used for iodine releases.
  • There was some general discussion regarding detailed planning zones and the implication of using Reference Levels rather than Emergency Reference Levels. In the examples PHE have looked at, using the existing ERLs would ensure that the proposed Reference Levels are met.
  • Currently inconsistencies between the levels for planned and existing exposure situations and Radioactively contaminated land.  There are currently grey areas.  These will be dealt with on a case-by-case basis but it would be good if there are illustrations in the guidance.
  • IAEA are currently revising their guide (RSG 3.1) on contaminated land and tackling the reference level issue and how to handle public expectations, particularly during the transition period from emergency to recovery to existing.
  • The new DGEM/EX levels would appear probably in National Nuclear Emergency Guidance.

Out-of-Scope and Exemption levels

  • It was questioned whether it will be possible to make out-of-scope /clearance levels the same for delicencing of sites under NIA65 and RSR. NIA guidance currently refers to EPR for out-of-scope/clearance values.  No changes to NIA would occur as a result of BSSD, but that there were moves afoot to replace NIA with the general licencing arrangements which will be implemented as a result of BSSD (i.e. in IRR and RSA/EPR).
  • Consistency of out of scope levels was raised with regard to radioactivity in groundwater – considered a hazardous substance by the Groundwater Daughter Directive (not Euratom). Using the WHO drinking water concentrations was suggested, that this issue had been previously discussed in government and guidance had been issued to sort it. This directive is regulated by SEPA in Scotland but would be DEFRA in England. Probably won’t be able to sort cross department/directive issues in this round.
  • There was discussion regarding whether the out of scope and exemption levels were above local background and how local background could be established for sites with no information before they’d been contaminated! There is currently good guidance available for determining background levels. Can background levels of activity/radiation be formalised in the regulations?
  • More guidance needed for existing sites with no ‘pre-use’ background information.

Exemption for liquid waste is required

  • In respect of having/needing a liquid waste out of scope level, example costs were given for disposing of small volumes of low activity tritiated waste (e.g. rainwater arisings) from dockyards of around £75k per year.

Permitting/notification arrangements

  • Might be appropriate to notify some sources which are exempt, perhaps using standard permit even though not strictly required.
  • It was a little unclear why a number of gas chromatography sources weren’t registered and it was felt that more guidance was needed for the users of such sources and that stricter regulation, particularly around the disposal of sources when the equipment was no longer required or in use was necessary. It is intended that a new exemption was planned which would have a total activity on site rather than a total activity per source.
  • Scotland are keen to introduce the notification level for RSR.
  • Concern about heterogeneous exposures (eg hot particles) –is it possible to limit the area or is there a need to permit the whole site?  Noted that this would be an ‘Existing exposure situation.

NORM issues

  • It would be preferable if out-of-scope and exemption levels were set more consistently across all regulations (IRR, EPR, RSA, CDG, REPPIR) going forward, particularly for NORM where REPPIR may apply but the site doesn’t need to be permitted under EPR/RSA. There is the intention and that the Environment Agencies have been talking to HSE about this. However, it is likely to be tricky to bring all of the relevant work streams together in time and ultimately different ministers will make the decisions regarding the different pieces of legislation.
  • Concern on the potential increase in the NORM waste exemption level for lead-210 was previously raised at the SRP meeting, Radioactivity in the Scottish Environment, held on 1 December 2016. A number of clients in the oil and gas industry were approached by the industry body, Oil and Gas UK, to put forward estimated financial impacts of increasing the exemption and clearance thresholds for NORM decay chain segments. The specific example quoted was raising the NORM waste exemption for Pb-210+ and Po-210 from 5Bq/g to 100Bq/g. This is clearly a big change and the majority of NORM waste from the gas sector lies within this gap so the impact would be significant (positive in the eyes of the industry). How would this fit in terms of calculating the exemption status of NORM material where Pb-210 is not the head of chain? The NORM concentration factor under the current regime would not accommodate differing exemption values for individual radionuclides.
  • There is a need for comfort (in the guidelines?) when a common sense approach is taken for NORM isotopes below background levels


  • It is good that sources would cease to be HASS as they decayed and that annual reporting was no longer required.
  • It would be a good idea if we could include ‘decayed below HASS level’ date on HASS notification form.

Crown immunity

  • There will be no change for sources contained within reactors or regarding Crown immunity in the new regulations

Other issues

  • Statutory levels and guidance should be easily available, as there was some concern that some relevant information has been archived.
  • There is a need for the proposed regulations and guidance to be available at the same time.
  • Please provide positive feedback to EAs as well as negative regarding website, guidance etc.

Conclusions and next steps 

It is anticipated that the proposed IRR18 and the ACoP will be available early 2017.  The RSR are likely to follow a short while later.   It is likely that due to time constraints there will not be wide consultation for the associated guidance.  There will be separate consultation for the changes to legislation in Scotland. SRP are organising a number of Stakeholder meetings for the new regulations. For further information please click here

SRP will support the production of guidance where the regulators are unable to provide it

Members are invited to post any comments questions on the proposed new legislation on the forum for further debate. With any comments for the new regulations it is really helpful to have specific examples and details regarding issues with the current regulations.


Thank you to the speakers and contributors to this meeting.

I am very indebted to Jill Reay for providing me with her notes for this meeting which forms the basis for these notes – all the errors are mine! 

Chris Perks

Secretary, SRP BSSD 2013 Working Group

December 2016

Background and Consultation - Roger Collison, Babcock International and BSSD2013 Working Group Chairperson and Jerry Anderson, Augean PLC

The graded approach - Juliet Long, EA

Radioactive sealed sources - Peter Brember, EA        

Radioactive waste clearance and exemption -  Angela Wright, SEPA

Reference levels for public exposure and Public dose constraints - Antony Bexon, PHE                            

Existing exposure situations/contaminated land - Juliet Long, EA

View the programme from the day here

Implementation of BSS to Radioactive Substances Regulations - Join the Debate! (8th December)

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