This snapshot, taken on 21/12/2003, shows web content selected for preservation by The National Archives. External links, forms and search boxes may not work in archived websites.

Department for Environment, Food & Rural Affairs

Proposals for The Radioactive Substances (Basic Safety Standards)
(England and Wales) Regulations 2000
and
The Radioactive Substances (Basic Safety Standards)
(England and Wales) Direction 2000

Consultative Document

Introduction
Background
Radioactive Substances Act 1993 Consultation on Principles – March 1999
Responses to the Consultation on Principles
Proposed Changes:
Proposed Changes: The Radioactive Substances (Basic Safety Standards) (England and Wales) Regulations 2000
Proposed Changes: The Radioactive Substances (Basic Safety Standards) (England and Wales) Direction 2000
Next Steps
Regulatory Impact Assessment
References

Annexes (see Adobe Acrobat file below)
Annex 1: Draft Radioactive Substances (Basic Safety Standards) (England and Wales) Regulations 2000
Annex 2: Draft Radioactive Substances (Basic Safety Standards) (England and Wales) Direction 2000
Annex 3: Draft Regulatory Impact Assessment (HTML)

Introduction

1. This document contains proposals for changes to the Radioactive Substances Act 1993 (RSA 93) and proposals for a Direction to be given to the Environment Agency in order to implement aspects of the European Directive 96/29/Euratom concerned with the control of radioactive waste. The Directive lays down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation.

2. With the Government pledged to making government more accessible and responsive, an important feature of this approach is effective consultation with all interested organisations. This leads to more realistic and robust proposals, which is particularly important when dealing with proposed legislation. In March this year, the Government published a consultation paper "The Radioactive Substances Act 1993: Implementing the Revised Basic Safety Standards Directive Euratom 96/29." This sought comments on the basic principles for change – including the setting of levels of radioactivity below which radioactive material should be considered outside the framework of regulatory control. This document forms the second stage of the consultation process with the aim of gathering views on the proposed legal instruments to implement the Directive.

3. This document:

4. In general, the devolved administrations in Scotland, Wales and Northern Ireland have assumed responsibility for environmental issues and hence management of radioactive waste policies and legislation affecting their respective countries. However, this consultation is being undertaken by the Department of the Environment, Transport and the Regions for England and Wales since the proposals are concerned with amendments to primary legislation and these powers have not been devolved to the National Assembly for Wales. Parallel proposals are to be the subject of separate consultations in Scotland and Northern Ireland.

5. Responses to the document should arrive no later than 20 March 2000. Details on where to send comments are given below. All responses may be made publicly available unless you expressly request otherwise. You may send your comments in whatever form is easiest for you. Each response will be acknowledged, but detailed responses will not be possible.

6. Comments should be sent to:

Tony Brown
Zone 4/E7
Radioactive Substances Division
DETR
Ashdown House
123 Victoria Street
LONDON
SW1E 6DE
Tel: 020 7944 6275
E-mail: bss.directive@defra.gsi.gov.uk.

7. The document is also available on the Internet at www.defra.gov.uk/environment/consult.htm.

Background

8. Since its establishment in 1928, the recommendations of the International Commission on Radiological Protection (ICRP) have provided the basis for the conceptual framework and key principles of radiation protection internationally and have stimulated legislation worldwide. In 1977 the ICRP published general recommendations (ICRP 26) (Ref 1) which led to the adoption by the European Community of Directive 80/836/Euratom. This Directive laid down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation and is commonly known as the Basic Safety Standards (BSS) Directive. The Directive was largely implemented by the Ionising Radiations Regulations 1985 with the Radioactive Substances Act 1960 (RSA 60) covering those aspects of the Directive concerned with the protection of the public and the environment from the discharge or disposal of radioactive waste.

9. In 1990, following reappraisal of the risks of exposure to ionising radiation, the ICRP published new general recommendations (ICRP 60) (Ref 2). In 1993, the European Commission published proposals for a revised BSS Directive which took account of these recommendations on how to improve protection. The recommendations are evolutionary in nature and do not fundamentally change the system of radiological protection on which the Directive is based. The revised Directive 96/29/Euratom was adopted in May 1996 and is to be implemented in Member States by 13 May 2000.

10. The revised BSS Directive will be implemented in the UK through a number of different Acts and regulations including the RSA 93. This Act already contains many of the features of the revised Directive and, with its predecessor RSA 60, has stood the UK in good stead for the past 30 years. It provides an effective and flexible mechanism for control of radioactive waste and, as stated in paragraph 8, currently implements those aspects of the existing Directive dealing with the discharge or disposal of radioactive waste.

11. In relation to RSA 93, the most important provisions of the BSS are those of Article 5, which makes the disposal, recycling or reuse of radioactive substances above clearance levels subject to prior authorisation. Because most materials contain some radioactivity it is important to set thresholds in regulations below which materials will be treated as outside the framework of control. The Directive therefore permits Member States under this Article to set levels of radioactivity below which materials can be disposed of, recycled and re-used without needing prior authorisation. This concept is known as clearance, with clearance levels setting a threshold at or below which the levels of radioactivity are small and pose negligible radiological risk, irrespective of the volume or future use of that material.

12. The concept of clearance used in the Directive does not appear explicitly in UK legislation. However, there are levels in current legislation which could be used for unconditional clearance of large volumes of material. These are Schedule 1 of RSA 93 - which defines at what levels naturally occurring substances are considered radioactive; and the Substances of Low Activity Exemption Order (SoLA) made under RSA 93 - which essentially deals with all man-made radionuclides and provides unconditional exemption for solid materials meeting the specified concentration limits.

13. In other defined situations, exemption from specified provisions of RSA 93 is granted by means of Exemption Orders made under Sections 8, 11 or 15 of the Act. Currently there are sixteen such orders under RSA 93 in addition to SoLA. Several of these apply to specific practices or work activities whilst others refer to particular types of radioactive materials or waste. In most cases, the exemptions are granted subject to limitations and conditions. Work commissioned by the DETR has shown that the current Exemption Orders, which may need to be revised for other reasons, do meet the requirements of the Directive (Ref 3).

Radioactive Substances Act 1993 Consultation on Principles – March 1999

14. The Government consulted on the principles for implementing the revised BSS Directive in March 1999. The Government made it clear that it considered RSA 93 a suitable framework for implementation of parts of the Directive and that there was no need for change to its basic structure.

15. In addition, recognising that the current values in Schedule 1 of RSA 93 and SoLA met the requirements of the Directive (Ref 4) there was a presumption of no change to the existing clearance levels. Consultees were invited to come forward with proposals for change and to discuss the relative merits of such changes.

16. In the consultation paper views were sought on:

17. In addition, the consultation paper highlighted a number of areas where it was thought that action would, or might, be necessary in order to implement the Directive but where comments were not specifically sought.

Responses to the Consultation on Principles

18. Whilst there was some concern about the logic of the distinction between natural and man-made radioactivity and that its retention would reinforce the popular misconception that natural radioactivity is less harmful than artificial, there was wide-ranging support to retain the existing regime. The Government therefore proposes to retain the existing system which distinguishes between natural and artificial radioactivity.

19. There was wide-ranging support for work activities and practices as defined by the Directive to continue to be treated in a single regime. The Government therefore proposes to retain the existing system of treating work activities and practices within a single regime.

20. Opinion was equally divided on whether the existing values in Schedule 1 for solids, liquids and gases should be changed. While some respondents argued that a system based on specific radionuclides would have greater scientific rationale, there was broad acceptability of the current values by practitioners. Industry, in particular, expressed the view that because the current values offered adequate protection, the changes necessary to comply with a new system by both users and regulators would represent an unnecessary burden. The preferred alternative of those wishing change was for a system based on radionuclides rather than radioelements. The case for changing Schedule 1 to include radionuclide specific values was largely based on the desire to see the best science used and a more transparent system adopted, rather than on any practical considerations. Having considered the views in the light of the presumption of no change, the Government proposes to retain the existing values. Schedule 1 levels for solids, liquids and gases will therefore continue to be expressed in terms of radioelements at their current values.

21. Opinion was also divided on the need for change to the levels contained in SoLA. Although there was a measure of support from both industry and the environmental groups for the retention of the existing SoLA levels, the overall response from users was in favour of change, to varying degrees. Those in favour of change argued for a system where individual clearance levels for radionuclides would be defined on the basis of the relative risks of the radionuclides. This was seen as having greater scientific rigour. Different views were expressed by environmental groups and a number of members of the public who wished to remain with the current system. There was little support for the banded approach put forward in the March consultation document. It should be noted that SoLA is only one component of the exemption system and is intended to give unconditional clearance at low levels. In other defined situations - where it is warranted - conditional exemption orders are made. SoLA's purpose is similar to that of Schedule 1 in providing a threshold level above which radioactive substances need to be regulated. The system of conditional exemption orders provides the means of taking into account detailed technical considerations as they apply in particular circumstances. Having considered the views in the light of the presumption of no change, the Government therefore proposes to retain the existing single SoLA values.

22. There was overwhelming support from all stakeholders for a review of the system of Exemption Orders. There were mixed views though on the degree of change required. A review of Exemption Orders is being undertaken as part of the Department's research programme.

23. A more detailed analysis of the consultation responses is available on request from the DETR at the address given in paragraph 6.

24. A number of respondents raised concerns about wider radioactive waste management issues which were beyond the remit of the consultation. It is, however, the Government's intention that changes to RSA 93 should be limited to those required to implement the Directive and such concerns are not addressed at the present time.

Proposed Changes

25. The consensus coming from the consultation was that whilst the current regime could benefit from an update it does provide a simple, robust and effective control framework for radioactive waste. The Government believes that changes - in the absence of any strong practical arguments - would place an unnecessary burden on users and regulators alike.

26. The following paragraphs explain the changes that are necessary to implement the Directive. In summary they are:

The Radioactive Substances (Basic Safety Standards) (England and Wales) Regulations 2000

27. The proposed changes to RSA 93 in the draft Statutory Instrument at Annex 1 are limited to the way that the Act deals with clocks and watches. Under Sections 8 and 15 of the Act the keeping and use of clocks and watches, of any description, containing radioactive luminous material is exempt from registration and authorisation. This does not, however, apply to premises on which clocks or watches are manufactured or repaired by processes involving the use of luminous material because of the potential for a more significant risk from such processes.

28. The Directive requires prior authorisation for the disposal of all radioactive substances arising from practices subject to reporting. This authorisation need not be on a case by case basis where there is a limited risk of exposure and the circumstances are laid down in national legislation.

29. To comply with the Directive, it is proposed that RSA 93 is amended so that the exclusion of clocks and watches is limited to circumstances where the total radioactivity on the premises at any one time does not exceed the relevant reporting levels in the Directive; or where specified limits on the quantity of radioactive waste and the types of clocks and watches are met. The levels set out in Table 2 of the regulations are those permitted by the relevant international standards. On the basis of dose calculations for the disposal of clocks and watches undertaken as part of a DETR research project (Ref 5) it is clear that the disposal of 5 items of the type defined in the regulations would pose no danger to public health.

The Radioactive Substances (Basic Safety Standards) (England and Wales) Direction 2000

30. Several Articles of the Directive impose requirements of an administrative nature that are relevant to RSA 93. These requirements are already undertaken by the Environment Agency through administrative means and the draft Direction to the Environment Agency at Annex 2 makes these arrangements binding requirements under Section 40(2) of the Environment Act 1995. The following paragraphs briefly describe these requirements.

31. Article 6.3 requires the principle of optimisation to be applied in order that all exposures to individuals are kept as low as reasonably achievable. Article 14 similarly deals with the optimisation of the exposure of the population as a whole. A legal obligation will therefore be placed on the Agency to ensure when granting RSA 93 authorisations that resulting exposures to individuals and the population are as low as reasonably achievable, social and economic factors being taken into account.

32. The Directive lays down mandatory dose limits for members of the public. Article 13 prescribes a dose limit of 1 millisievert effective dose in a year – the same dose as currently endorsed by the Government. In granting RSA 93 authorisations, the Agency will therefore have an obligation to ensure that as a consequence no member of the public receives a dose in excess of the dose limits laid down in Article 13.

33. The Agency will need to observe the technical procedures laid down in Article 45 of the Directive for the estimation of population doses for the purposes of paragraphs 31 and 32 above.

34. The use of dose constraints, where appropriate, within the context of optimisation of radiological protection is advocated in Article 7.1 of the Directive. The Government endorses the use of dose constraints for particular applications (Ref 6). A legal obligation will be placed on the Agency to have regard to them.

35. There will be an obligation upon the Agency to follow the technical procedures required by Articles 15 and 16 in estimating effective and equivalent doses.

36. In relation to Article 47, the Direction places an obligation on the Agency to ensure that undertakings discharge their responsibilities under this Article. This will mean that technical devices used to demonstrate compliance with the conditions imposed in authorisations are fit for the intended purpose and that a suitably qualified expert is involved in the discharge of these activities.

Next Steps

37. Comments on the proposed changes would be welcomed by 20 March 2000.

38. As stated in paragraph 13, it has been determined that the existing Exemption Orders under RSA 93 are consistent with the Directive and meet the criteria of Annex 1. However, as paragraph 22 goes on to indicate, a review of Exemption Orders is currently being undertaken as part of the Department's research programme. Informed by the results of this, a decision will be taken on whether to update or radically change the orders. Any new regulations or orders will be the subject of consultation.

39. Guidance in the form of an introduction to RSA 93 will be produced.

Regulatory Impact Assessment

40. A draft Regulatory Impact Assessment has been prepared and is at Annex 3. The minor changes proposed to the current regulatory framework mean that the consequential effects on users of radioactive materials are limited in nature. The only change to RSA 93 is the way it deals with clocks and watches and the regulations have been drafted to minimise the impact whilst remaining consistent with the Directive. Other users of radioactive materials and the regulator will be faced with one off training costs.

41. The Government would welcome views on this document. It will be revised in the light of comments and further information received during consultation.

References

1. ICRP Publication 26. 1977 Recommendations of the International Commission on Radiological Protection. Annals of the ICRP, Vol 1 No. 3. 1977.

2. ICRP Publication 60. 1990 Recommendations of the International Commission on Radiological Protection. Annals of the ICRP, Vol 21 No. 1-3. 1991.

3. DETR/RAS/99.015 Review of compliance of Exemption Orders with requirements of the BSS Directive. Report for the Department of the Environment, Transport and the Regions. Alan Martin Associates. 1999.

4. DETR/RAS/98.004 Derivation of UK unconditional clearance levels for solid radioactive materials. Report for the Department of the Environment, Transport and the Regions. M D Hill, M C Thorne, P Williams and P Leyshan-Jones. 1998.

5. DETR/RAS/99.017 An assessment of the keeping, use, display, repair and disposal of clocks and watches containing quantities of radioactive material in excess of the Basic Safety Standards (96/29/Euratom) exemption levels. Report for the Department of the Environment, Transport and the Regions. A D Gulson, R A Paynter and S Mobbs. 2000.

6. Review of Radioactive Waste Management Policy. Cm 2919. 1995.


The complete document is made available in Adobe Acrobat format for downloading.
The Adobe Acrobat Reader can be freely downloaded.

Published 14 February 2000 / Updated 17 February 2000
Radioactivity Index
Environmental Protection Consultation Papers Index
Environmental Protection Index
Defra Home Page