Are there limits to what should be regulated?
Article Outline
The title summarises one of the more problematic issues of contemporary technological society. The possibly controversial answers to this fundamental question should not be expected to be unambiguous. Why does society require control of some endeavours and disregard control of others? Radiological protection has not been immune to this dilemma: Why have relatively modest radiation exposures been subject to rigorous control, while relatively high (and controllable) exposures have been basically uncontrolled (sometimes on the dubious grounds that the exposures were ‘natural’ in origin)? Given that the recommendations of the International Commission on Radiological Protection (ICRP; the Commission) assume that any added radiation exposure (however small) adds a risk (however small), it might be assumed that all sources of exposure (however minute) should be controlled and regulated. However, some sources of radiation are ubiquitous and essentially uncontrollable. Moreover, expending disproportionate societal resources for controlling trivial exposures may not be the best possible way of implementing the Commission’s basic principle of optimisation of radiological protection. Over the years, radiological protection practitioners and regulators have been confronting this dilemma, but a universal solution remains elusive. Therefore, ICRP has produced this report with the aim of offering advice to competent national authorities and relevant intergovernmental organisations, to assist them in defining the scope of their specific radiological protection control measures. The report has been open for review via the Commission’s web site and generated many, and divergent, comments. Due to the nature of the present report, on this occasion the comments received were not just taken into account, but many of them are also cited in this editorial or in the main text; all cited comments. This report offers advice to competent national authorities and relevant intergovernmental organisations for their definition of the scope of radiological protection control measures. The report has been widely consulted via the International Commission on Radiological Protection (ICRP) website, with the consequent revisions being cited in this editorial or in the main text; all citations are referenced at the end of the report.
The advice in this report is based mainly on the ICRP protection principles of justification and optimisation. It aims to provide an efficient control of radiation exposure situations, rather than ‘deregulation’ or reducing regulatory control to the detriment of public interest (Johnsrud, 2006).
It should be noted that control measures are implemented through regulations, and regulations necessitate a defined scope. The scope of radiological protection regulations constitutes the boundaries within which radiation exposure situations must be regulated. Defining this scope should not be construed to be against precautionary principles (EEA, 2001) that specifically recommend preventative approaches (Folkers, 2006). The Commission has indicated unambiguously (ICRP, 2007, Para. 36) that its recommendations are commensurate to the precautionary principle set up within the United Nations system (UNESCO, 2005). The Commission is aware of the concept of ‘negative surprises’ implicit in the precautionary principle, which includes complex, cumulative, and potentially synergistic or indirect effects, and considers that regulators should acknowledge the possibility of a negative surprise when defining the regulatory scope of radiological protection regulations (Folkers, 2006).
There are several reasons why the regulatory scope needs to be defined. People, organisations, and society as a whole should know the extent of regulations applied to them. They expect governments to put regulatory systems in place, but do not expect regulations to intervene unnecessarily in their lives or place restrictions on their rights and freedoms without good reason. Therefore, regulations should be restricted to circumstances where they are justified, and the application of regulatory requirements should only be implemented if they are considered to be the best (optimum) option of protection under the prevailing circumstances.
In spite of the fact that some intergovernmental agreements on regulatory scope are available, the issue has been controversial and has eluded international consensus. Both at national and international level, approaches to define the extent of regulatory systems have not been completely consistent. This situation has produced some ambiguities in the international treatment of this issue, which is reflected to some extent in this report (McAulay, 2006). While the report cannot completely remove the current vagueness on the issue, it may help to enhance global consensus while keeping a reasonable degree of flexibility. In this regard, the report makes wide use of references to a broad range of consensus guidelines on scope, established under the aegis of international intergovernmental organisations. However, it makes clear that these references should not be interpreted as supporting or criticising what has been established by these organisations because such judgements have no place within the recommendations of ICRP. It would be inappropriate for ICRP to endorse or disapprove numerical levels for defining scope that have been agreed by national or intergovernmental bodies. Establishing such levels requires political judgements that are outside the role of ICRP, which is to provide a radiological protection framework in which national and international organisations can work to establish scope levels (Hill, 2006). Hence there is no need for ICRP to mandate specific numerical guidance on scope, such as radioactivity concentration that should be regulated. While global consensus on this guidance should be pursued, this should be within the remit of international intergovernmental organisations (Janssens, 2006).
Thus, this report should not be construed as extending the commonly understood assignments of ICRP, or interfering with the sovereignty of national legislation and the indisputable rights of the national regulators (Landfermann, 2006). Moreover, it should not be taken to imply that it is within the Commission’s responsibilities or competence to specify what regulators or legislators should or should not do (Hill, 2006, Stather, 2006), among other reasons because there are different regulatory regimes and not just prescriptive regimes (Lumb, 2006). This report refrains strictly from covering aspects that are bound exclusively to national rights and responsibilities, and its recommendations should not be interpreted as prescriptive or pre-emptive of national authority (Lazo, 2006). Instead, the recommendations should be taken as suggested generic conceptual indicators for defining the regulatory scope, in the understanding that the definitive boundaries establishing the exposure situations to be regulated would very much depend on national approaches, and that they should therefore be put into perspective by allowing for national deviations.
While this report goes beyond giving recommendations that may only be applied through regulation — there are other means of controlling exposures, for instance when dealing with radon exposure in dwellings (Wymer, 2006) — its title may be interpreted as overly broad and promising the reader much more than its limited content. In fact, the main aim for defining scope should be to address what should be covered rather than what should not be covered. This report, however, basically deals with what is outside rather than inside the scope, since the discussion on what should not be covered is more straightforward.
Bearing in mind the Commission’s new and more inclusive approach to radiological protection, which now covers the protection of the environment, it should be underlined explicitly that this report only relates to the scope of radiological protection control measures for humans.
The report includes a rather detailed discussion on the complex issues involved in determining scope with the intention that it should be explicable to a wide audience. Scope-related issues are complex and need to be explained in detail for the report to serve this purpose (Janssens, 2006). However, this approach has the downside of making the report rather cumbersome, and perhaps insufficiently straightforward about the preferable options that should be retained (St Pierre, 2006). The complexity of the arguments developed in this report could be seen by the reader with some apprehension (Coates, 2006, Stather, 2006), particularly its chronological development, because it may be considered that there is no need to dwell either on the dead branches of the historical evolution or on its possible misinterpretations (Janssens, 2006). The Commission, however, has considered it appropriate to describe the past progress in the field, even the unsuccessful efforts in the development of the current regulatory approach to scope [which many regulators consider, in fact, quite unambiguous (Laaksonen, 2006)]. Past efforts were useful in their time and contributed to the development towards the current state of the art. The scrutiny of what has happened over time on the issue of scope could clarify the way forward.
The report also addresses past alleged linguistic problems; this is important because misunderstandings sometimes arise from deficient communication. It encourages regulators to simplify the definition of scope as much as possible. The issue of over-riding importance to practitioners is that the simplest, most coherent, and readily understandable platform should be provided for controlling exposure situations involving very low doses or radioactive materials containing very small amounts of radioactivity (Coates, 2006). It should be recognised that simplicity and clarity are particularly important in the context of radiological protection regulations, because they are fundamental to good understanding by all stakeholders of the regulations and their implementation (St Pierre, 2006).
Some may feel that the determination of what constitutes a justifiable regulatory requirement should not be left in the hands of legislators and regulators, but should be the remit of radiological protection science (Johnsrud, 2006). However, the formal definition of regulatory scope is the sovereign task of national administrations, which are responsible for the ultimate decisions on the boundaries between what is ‘inside’ and ‘outside’ the radiological protection regulations. Internationally agreed concepts and principles on how to derive appropriate values for defining scope may be taken into account by national authorities with due regard to specific national conditions. However, the formal definition of scope is an indispensable right of the national legislators who may decide whether a particular exposure situation is important, and whether to include this situation in the national radiological protection regulations, whether control is warranted or not, and under what conditions a release from the regulator’s control can be granted depending on the qualitative or quantitative features of the situation (Landfermann, 2006). The Commission has clearly expressed that its competence and responsibilities do not include the formal quantitative definition of radiation protection situations that are unimportant or where control is unwarranted, but that its advice can be useful to those with such competence and responsibility by contributing to improvement of the regulatory consistency and coherence as well as its consolidation and simplification (St Pierre, 2006).
In summary, therefore, while this report refers to radiological protection regulations, this should not lead to a perception that the intention of the ICRP is to get involved in legislative and regulatory matters (Wymer, 2006). It is up to regulators to decide on the best way to implement the recommendations (Janssens, 2006), and up to them, rather than to ICRP, to define the boundaries of regulatory control, taking international guidance into account (Lumb, 2006).
Under the above framework, this report aims to advise national bodies and any competent authority in radiological protection. It can certainly not be interpreted as pre-empting the ability of subnational governments and communities to provide greater levels of protection for their citizens (Johnsrud, 2006). Rather, this report should be received as a step forward in clarifying a number of issues that, until now, have not been properly resolved or have been the subject of differing interpretations and confusion. Such clarification and, importantly, the supporting discussion have already been of great significance and value in the ongoing review of international radiation safety standards taking place under the aegis of the International Atomic Energy Agency (IAEA), where the report will be welcomed as a positive step forward in improving understanding (including clarity on the meaning of specific terms) and practicability (e.g. flexibility where it is needed) (Wymer, 2006). Discussions on scope will continue actively in intergovernmental organisations, and between them and ICRP. The issue is being addressed not only in the IAEA revision but also by the Nuclear Energy Agency/ICRP stakeholder dialogue conferences, and by the Committee on Radiation Protection and Public Health Expert Group on the Implications of ICRP Recommendations (Lazo, 2006). Hopefully, this report will contribute to a rational answer to its editorial title!
References
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PII: S0146-6453(07)00053-X
doi:10.1016/j.icrp.2007.12.003
© 2007 ICRP. Published by Elsevier Inc. All rights reserved.
