RWMAC's Annual Report for 2000-2001

Annex 5

RWMAC Response to the Consultation on Statutory Guidance on Regulation of Radioactive Discharges into the Environment from Licensed Nuclear Sites

1. Introduction

This document sets out the Radioactive Waste Management Advisory Committee's (RWMAC's) response to the Government's consultation on Statutory Guidance on the Regulation of Radioactive Discharges into the Environment from Nuclear Licensed sites. The Guidance was the subject of a consultation paper issued by the Department of the Environment, Transport and the Regions in November 2000 ¹.

The provisions of this consultation are clearly linked with that issued earlier in June 2000 on the UK Strategy from Radioactive Discharges 2001-2020 ², to which RWMAC responded on 29 September 2000 ³. Many of the points made in this response correspond to those which were made earlier in response to the Discharges Strategy consultation.

2. RWMAC's general position on the consultation

In its May 2000 report on the work of the Environment Agency, the House of Commons Select Committee on Environment, Transport and Regional Affairs stated that ⁴ :

"It appears that the Agency is working almost in a vacuum where regulatory principles are concerned with the result that neither they, nor those they regulate, nor the general public, can be clear of what is required in this area. We strongly urge the Government to produce as soon as possible, in consultation with the Agency, a clear statement of regulatory policy and practice in the area of radioactive substances and waste".

The Select Committee's conclusion accords with RWMAC's views which have been stated publicly on numerous occasions (see for example, references ³ and ⁵).

Against this background, RWMAC warmly welcomes the Statutory Guidance proposals as a major step forward. However, in the Committee's view, the draft guidance does not as yet go all the way towards a comprehensive statement of the way radioactive discharges are regulated within the UK. There remain a number of areas of difficulty, contradiction and/or omission which are discussed in the following sections of this response.

The ultimate aims of the Statutory Guidance and the way it is interpreted by the EA must be to establish a clear and consistent basis for regulation and to provide those who are regulated and the public whom the regulation is designed to protect with a clear explanation andunderstanding of the way in which regulatory decisions are arrived at. Within this, it must providea means of understanding how regulatory policies relate to established principles (notably those of radiological protection), EU law and other international commitments. The form of regulation should be common across all relevant sectors unless the reasons otherwise are clearly stated and justified.

In the past RWMAC has been critical of the degree of transparency achieved in EA discharge authorisation consultations. The Committee believes that as a general principle regulatory principles and processes should be set out in a clear and understandable fashion, particularly if the public are to be sensibly involved in consultation exercises. More recently there have been improvements that the Committee has acknowledged in its various consultation responses. But fundamental problems of process definition remain.

This is characterised by the EA's recent Magnox consultation documents ⁶ which contain a section on Legal and Policy Framework and International Commitments. This, in effect, simply lists the dose-based limits and constraints of the 1995 Cm 2919 policy statement ⁷, the discharge reduction objectives of the 1998 OSPAR agreement, the threshold for optimisation concept and so on without any real indication of how their potentially conflicting respective provisions are to be suitably reconciled in the decision-making process. It also talks of the need to justify practices involving the use of radioactivity when the means by which this should be carried out have still not been determined in light of the revised 1996 EU Basic Safety Standards Directive (although RWMAC understands that progress has been made towards this particular objective).

References are also made to terms such as As Low As Reasonably Achievable (ALARA), Best Practicable Means (BPM) and Best Practicable Environmental Option (BPEO) which, in RWMAC's view, are still not adequately defined from the point of view of public understanding. The Committee accepts that some of these may be interpretative and judgmental but the general criteria by which their application is judged should at least be made clear.

There are other criteria that RWMAC believes need to be identified, explained and taken into account if regulatory practice is to be defensible. These are decisions that should be based on best available science and sound economic principles and that due weight should be given to the degree of protection that the public can reasonably expect of a modern society in light of its ever-developing technology.

It is from this general position - that the regulatory principles and the manner in which they are applied need to be clearly formulated, logical and set out in a manner that is understandable - that the following RWMAC observations on the proposed Statutory Guidance are made.

3. Major points of concern

Four major points of concern to RWMAC in respect of the proposed Statutory Guidance are discussed in this section. These are coverage of the proposed Guidance, reconciliation of dose-based and activity-based regulatory criteria, allowance for effects on radiation workers and the manner of handling of the justification issue. Other issues are discussed in the following section. A number of the latter relate to practical interpretation of the principles.

Coverage

As with the UK Strategy for Radioactive Discharges 2001-2020, RWMAC notes that the Statutory Guidance proposals refer only to nuclear licensed sites. As the Committee's earlier comments on the Strategy proposals make clear, RWMAC sees a need to have a common approach to issues of radioactive waste across all relevant sectors. Coverage of non-nuclear sites is a major omission that must be addressed. For example, section 5 of this response sets out some of the potential difficulties that might be encountered if the Statutory Guidance proposals as they stand were applied to the medical sector.

In this instance, it is made clear that the Statutory Guidance applies to both liquid and aerial discharges and this is to be welcomed. The Committee felt that the previous Strategy proposals were insufficiently clear on this point.

Reconciliation of activity-based and dose-based criteria

RWMAC notes that paragraph 6 of the Explanatory Document acknowledges that the Statutory Guidance is based on essentially parallel criteria of amount of radioactivity on the one hand and radiation dose on the other. Paragraph 41 goes on to say that, in respect of the former, there should be "progressive reduction" and that this should take primacy over other considerations, apart from safety. It also suggests that this will be achieved by, but not limited to, the use of new technology as it becomes available.

In respect of this RWMAC reiterates the following points that were made in respect of the UK Strategy for Radioactive Discharges 2001-2020 proposals ³:

"RWMAC believes that it is right for the Government and the public to expect improvements in technology to be able to deliver progressively lower levels of radioactive discharges than in the past. It is clear that what has been regarded as acceptable in the past is no longer regarded as acceptable today. The development of technology is the primary vehicle for delivery of such improvement and there must be appropriate pressure on industry to continue to invest in the development and use of such technology.

Equally, as levels of discharges diminish, so does the level of risk to the public. It then becomes increasingly important to ensure that a justifiable balance between risk, cost and practicable benefit is also maintained. Otherwise, there is the risk of wasting resources. This is also one of the objectives behind the Government's Regulatory Impact Assessment procedures for new legislation ⁸. RWMAC's view is that the principles of such Assessment should apply equally to areas of existing legislation, including the regulation of radioactive discharges.

The proposed Strategy is also acknowledged to be based on the ICRP principle that radiological doses and risks from a source of exposure are kept as low as reasonably achievable, consistent with the relevant dose or target standard and have been reduced to a level that reflects a balance between radiological and other factors, including social and economic factors (the ALARA principle). The latter part of the ALARA principle definition - that is the need to take into account social and economic factors - thus also reflects the need to balance risk, cost and practicable benefit, subject to relevant social factors.

What is of some concern to RWMAC is that, in the light of this need, the proposed Strategy does not appear to acknowledge that there will inevitably come a point where the benefit of further reductions in discharge levels are likely to be outweighed by the cost of their achievement. RWMAC believes that the Government must be clearer on this aspect of ALARA application, namely how it views the trade-off between the three primary Strategy principles ^* and cost, either in its eventual strategy or in its guidance to the environmental agencies".

In short, the Committee would like to see a clearer indication as to how the progressive activity reduction requirement is ultimately to be reconciled with the ALARA, and indeed the BPM and BPEO (which also include reference to social and economic considerations) principles at low radiation dose levels. RWMAC also notes that paragraph 12 of the Statutory Guidance also requires the Environment Agency to look at the cost-effectiveness of its proposals. How is the term "cost-effective" to be decided in the context of low dose levels?

There is also another important conflicting consideration that needs to be suitably reconciled. Both paragraph 19 of the Statutory Guidance and paragraph 8 of the Explanatory Guidance also state the fact that there is widespread international agreement that individual doses to members of the public of the order 0.01 millisieverts (10 microsieverts) per year or less are sufficiently low to be of no regulatory concern. This agreement is effectively built in to the EU Basic Safety Standards and the IAEA International Basic Safety Standards. What is not made clear in the proposals is whether or not the UK Government accepts this view of this number. If it does not, it should be explained why. If it does, it must be clear why it considers further activity reduction to be necessary when doses to the most exposed member of the population are below this level, particularly if they are expensive to obtain. In this context, it should be noted that an additional radiation dose of this magnitude corresponds to an increased risk of death from cancer of less than one in a million when, in round terms, the national probability of death from cancer is about one in four. The Government should clarify what its position is on this point and consider further its precise implications for its Statutory Guidance proposals.

In short, there still appear to be important incompatibilities and inconsistencies between the various elements of the controlling principles that are set out in the Statutory Guidance proposals. If they are not reconciled at this stage, they will, in RWMAC's view, inevitably constitute significant ambiguities in the Statutory Guidance that the Government gives to the EA.

Doses to radiation workers

There is reference in several places in the proposals to the need to take account of doses to radiation workers. However, again as was noted in the RWMAC response to the UK Strategy for Radioactive Discharges 2001-2020 proposals, there is no explanation as to how this is likely to be achieved given that additional on-site processing of radioactive materials is almost certain to lead to increased doses to workers. Put simply, is the Government prepared to say what increase in dose to workers would be considered justifiable to save one microsievert of critical group dose? In this context, RWMAC notes that the dose limit to radiation workers, who receive economic benefit from employment in the industry, is 20 millisieverts per year whereas that for a member of the public is one millisievert per year.

Justification

The process of regulatory approval depends on the practice in question being justified. Justification is a requirement of the EU Basic Safety Standards Directive that should have been implemented by May 2000. It is the radiological protection principle under which no practice involving radiation exposure should be adopted unless it produces sufficient benefit to the exposed individuals or to society to offset the radiation detriment it causes. RWMAC understands that Government has now decided that it, rather than the EA, will be deciding justification issues in future. RWMAC believes that the way justification is to be handled in future needs to be clarified and implemented as soon as possible as it inevitably impacts significantly on the discharge authorisation process.

4. Other points

Construction of the document

As a general rule, the Statutory Guidance should state the key elements of Government direction and the Explanatory Document provide relevant background information and amplification. This is not always the case in the existing draft. For example, there is some repetition of wording. Illustrative instances are paragraphs 12 and 19 of the Statutory Guidance and 23 and 8 of the Explanatory Document. Some rationalisation may therefore be necessary in producing the final versions of these documents.

It is also unclear to RWMAC as to whether the material contained in the Explanatory Document has the same legal status as that contained in the Statutory Guidance. If it does not, there should be careful review toensure that all the necessary material upon which regulatory decisions are to be based are contained in the Statutory Guidance as opposed to the Explanatory Document. An example might be, for instance, the definition of possible exceptions to the progressive downward reduction in discharges principles which are contained in paragraph 41 of the Explanatory Document as opposed to the Statutory Guidance. Further, could the fact that there is no exception to the progressive reduction in collective dose in the Statutory Guidance effectively override the exceptional allowance for new justified processes in paragraph 41 of the Explanatory Document. This could be an important consideration, for example, in respect of any new nuclear build in future or developments in nuclear medicine that have implications for discharges.

"Concentrate and contain" vs "dilute and disperse"

Within the context of application to both non-nuclear and nuclear activities, the possible use of a "delay and decay" approach needs to be acknowledged.

Waste minimisation

In respect of paragraph 13 of the Statutory Guidance, it is unclear how the creation of solid, liquid and gaseous waste can be simultaneously minimised. All processes will invariably generate radioactive waste in one or more forms. Presumably if the primary emphasis is on reducing discharges, these must take precedence over solid waste considerations. But this may increase the amount of solid waste to be stored and the doses to workers involved in its handling. It is therefore felt that a fuller and clearer statement of the waste minimisation approach, that applies equally to the HSE as regulators of on-site activities, is needed.

Sociological and economic effects

The definitions of ALARA, BPM and BPEO, as set out in Cm 2919, all refer to the need to take into account social and economic factors and implications (this has been referred to previously). Paragraph 30 of the Statutory Guidance and paragraph 44 of the Explanatory Document talk of the need to consider legitimate uses of the seas and the land under a sociological and economic effects heading. RWMAC takes the social and economic elements of the ALARA, BPM and BPEO definitions to go much wider than this (e.g. effects on local communities, the national economy etc). So, to avoid possible misunderstanding, the heading under which these two paragraphs are presented should be changed.

BPM and BPEO

RWMAC accepts that BPM and BPEO need to be taken into account in deciding discharge authorisations. However, RWMAC believes that it is necessary for either the Government or, more probably, the EA, to provide a clearer statement of criteria that are used to judge the satisfaction of these requirements. As has been explained earlier in this response, RWMAC has noted a lack of transparency in EA consultation documents as to the way adherence to these criteria has been decided.

The Committee notes that the definitions of BPM and BPEO given in the Explanatory Document have changed from those given in the Glossary of Cm 2919. It would be helpful for the reasons for these changes to have been commented upon.

Calculation of doses

RWMAC notes that paragraphs 16 and 18 of the Statutory Guidance suggests that direct exposure, or shine, should be taken into account in calculating critical group dose for comparison with the public dose limit. This is also reflected in paragraph 31 of the Explanatory Document. This paragraph should also acknowledge explicitly that natural radiation and medical radiation should be excluded from any calculation.

The Committee also notes that paragraph 35 of the Explanatory Document also requires that direct exposure, or shine should be taken into account in calculating doses for comparison with the source constraint. This is another example of a progressive change in policy from that set out in Cm 2919 ⁷, which therefore continues to become increasingly out of date. Again there should be specific reference to exclusion of natural and medical radiation in carrying out dose calculation for comparative purposes. Paragraph 36, relating to estimation of the dose for comparison with the site constraint is not explicit on whether direct exposure should be taken into account, but this point does need to be made clear. If it is not included the reason for the difference, from inclusion in the source constraint, should be explained.

The Statutory Guidance makes clear that the reference group, as defined in the EU Basic Safety Standards Directive, may be taken as being the same as the critical group. For clarity, it would be helpful if the Explanatory Document could indicate why a group mean dose is calculated for comparison with individual limits and constraints. RWMAC welcomes the reference to "reasonable behaviour and dietary patterns of representative members of the public" in reference to the way doses should be calculated.

RWMAC has welcomed the fact that both the environment agencies and the Food Standards Agency (FSA) are currently carrying out reviews of their dose assessment methodologies, upon which the Committee has commented critically in the past ³. The Committee is providing its views in respect of both these reviews. In particular it feels that dose assessment methodologies must be open and transparent and that greater realism is necessary to ensure that a combination of very low discharge limits and conservative dose assessment does not, in practice, lead to disproportionate expenditure to secure overestimated benefits.

RWMAC remains concerned that the Food Standards Agency (FSA) may still be pursuing a somewhat different dose assessment approach to that which the environment agencies are proposing. The Committee remains to be persuaded that a totally different form of FSA approach is needed. If it is, the reasons must be fully set out and justified. Of key importance here is the fact that the provision of markedly differing forecasts of dose will be a source of confusion to the public that may lead to mistrust of the dose estimation process more generally.

Radiological impact on other species

RWMAC notes the direction for the EA to take account of the radiological discharges on other species. However, there is a need for the EA to have a fully-developed, widely-accepted and openly-declared means of doing this that takes adequate account of developing international thinking. Use of one-off ad hoc methodologies needs to be avoided.

Decommissioning

Paragraph 41 of the Explanatory Document, concerning progressive reduction of discharges, should acknowledge the need to take account of agreed decommissioning strategies.

Limits on individual radionuclides

Paragraph 40 of the Statutory Guidance lists five categories of radionuclides upon which the EA may impose limits. The second is those that are of significance in terms of the quantity of radioactivity discharged, which may or may not be of radiological significance. RWMAC believes that if the radionuclide is not of radiological significance, the EA should be required to take particular account of the cost likely to be incurred in achieving the specified level. This is to ensure a proportionate and cost-effective approach.

Comparison with Community Food Intervention Levels (CFILS)

RWMAC notes that paragraph 24 of the Statutory Guidance requires that routine radioactive discharges should not, in general, be set at a level where CFILS may be exceeded. To RWMAC, this represents a use for which the CFILS themselves were never intended. At the very least, an explanation for this should be given in the Explanatory Document.

Headroom

Re paragraph 52 of the Explanatory Document, headroom should be set such that expected and acceptable operation of the plant throughout the four-year licensing period, allowing for variation in throughput and maintenance, should not lead to breach of the authorised limits. There is a need for adequate realism here in interpreting the term "minimisation". Setting levels that are liable to lead to a number of discharge authorisation breaches when there is really no cause for operational or radiological concern is unlikely to be in anybody's interest.

EA processes

To ensure efficiency of process, the EA should make clear to applicants at the outset precisely what information is required to support an application for a discharge authorisation. RWMAC work has suggested that this is not always the case. Accordingly, the Statutory Guidance should take the opportunity to direct the EA to give clear guidance to applicants on the nature of the information required from them to support discharge authorisation applications.

Subject to the Government setting in place clear and unambiguous procedures for deciding the justification of practices, the EA should also be required to set itself clear timescale objectives for its decision-making processes. RWMAC believes that the length of time taken in deciding authorisations in the past has sometimes been unjustifiably long.

Future consultations

In respect of the consultation process itself, RWMAC notes that there is mention of terms and concepts that are likely to be unfamiliar to a member of the public. If there is real intent to engage members of the public in consultations such as this, annexes and glossaries that provide a fuller explanation of such terms and concepts and the issues and options involved should be provided.

RWMAC notes that a Regulatory Impact Assessment (RIA) ⁸ is to be drawn up following the consultation. The preparation of a draft RIA for distribution with such a consultation could, in practice, aid the public's consideration of proposals. It is therefore recommended that at least a preliminary RIA assessment is included in future consultations of this sort.

5. Perceived problems with the application of the statutory guidance to non-nuclear users of radioactivity

The introductory sections of the consultation document are drafted as though it applies to the whole spectrum of uses of radioactivity and has not been restricted solely to nuclear licensed sites. However, the draft guidance itself and its title do make specific reference to licensed nuclear sites.

Irrespective of this presentational point, it remains RWMAC's contention that, in the same manner as is being done for the nuclear sector, the principles behind the control of discharges from non-nuclear sites do need to be clearly formulated and made available for the benefit of the regulators' staff, those to whom the regulation is applied and the public whom the regulation is designed to protect. They should be the same as those for nuclear sites except where the reasons for doing otherwise are clearly stated and justified.

To give an example of the potential for differences between the two sectors, that might be encountered if the criteria set out in the Statutory Guidance proposals for nuclear licensed sites were to be applied to hospitals would include:

• a "concentrate and contain" strategy would be inappropriate for radioactive waste consisting mainly of patient excreta. "Dilute and disperse" is likely to be a more appropriate approach.
• for instance, retrospective fitting of holding tanks to existing hospitals would be expensive and difficult, and could lead to increased staff doses.
• there is little or no opportunity to exert pressure on reduction of discharges when most consists of patient excreta.
• minimisation of liquid waste following medical administration may be contrary to obtaining optimised medical outcome and dose reduction to the patient.
• the discharged radioactive patient who has been given radioactivity orally or by injection is a source of radioactivity, but not subject to RSA93 control once discharged.
• it is difficult to predict requirements for treatment or diagnosis using radioactive materials, so application of a minimised headroom policy could lead to unacceptable constraints on patient treatment
• it is unclear how the polluter pays principle would apply to the medical sector

For this reason, RWMAC believes that a comprehensive review of current medical/research/ education sector practice would be required if there is to be a transition from current policies of "dilute and disperse" for these sectors to one of "concentrate and contain". Such a review would have to be made in parallel with a full assessment of dose implications for staff, feasibility of safe storage arrangements and whether this could, ultimately, jeopardise health treatment. A fuller analysis of the activities and problems currently facing non-nuclear users of radioactivity - "Small Users" - was given in a recent RWMAC report ⁹.

References

1. Statutory Guidance on the Regulation of Radioactive Discharges on the Environment from Nuclear Licensed Sites: A Consultation Paper, Department of the Environment, Transport and the Regions, November 2000.

2. UK Strategy for Radioactive Discharges 2001-2020 : Consultation Document, Department of the Environment, Transport and the Regions, June 2000.

3. Twentieth Annual Report of the Radioactive Waste Management Advisory Committee, Department of the Environment, Transport and the Regions, November 2000.

4. House of Commons Select Committee on Environment, Transport and Regional Affairs Inquiry into the Environment Agency : Sixth Report (Report and Proceedings of the Committee), The Stationery Office, May 2000.

5. The Radioactive Waste Management Advisory Committee's Advice on Issues Which Need to be Addressed in the Guidance to be given to the Environment Agencies on the Principles for Determining Radioactive Waste Discharge Authorisations, Department of the Environment, Transport and the Regions, July 1998.

6. A series of Explanatory Documents and Draft Authorisations to Assist Public Consultation on applications by British Nuclear Fuels plc to Dispose of Radioactive Wastes from its Magnox Stations, The Environment Agency, May 2000.

7. Review of Radioactive Waste Management Policy : Final Conclusions, HMSO, July 1995.

8. Good Policy Making : A Guide to Regulatory Impact Assessment, Cabinet Office, 2000.

9. The Radioactive Waste Management Advisory Committee's Advice to Ministers on the Problems of "Small Users" of Radioactive Materials, Department of the Environment, Transport and the Regions, September 2000.

* Essentially parallel reductions in the radioactive content of discharges, radiation doses to the most exposed members of the public and concentrations of radioactivity in the environment. See Annex 8 of reference 3 for the full text of RWMAC's UK Strategy for Radioactive Discharges 2001-2020 consultation response.