ICRP Publication 104
Scope of Radiological Protection Control Measures
Recommended citation
ICRP, 2007. Scope of Radiological Protection Control Measures. ICRP Publication 104. Ann. ICRP 37 (5).
Abstract - In this report, the Commission recommends approaches to national authorities for their definition of the scope of radiological protection control measures through regulations, by using its principles of justification and optimisation. The report provides advice for deciding the radiation exposure situations that should be covered by the relevant regulations because their regulatory control can be justified, and, conversely, those that may be considered for exclusion from the regulations because their regulatory control is deemed to be unamenable and unjustified. It also provides advice on the situations resulting from regulated circumstances but which may be considered by regulators for exemption from complying with specific requirements because the application of these requirements is unwarranted and exemption is the optimum option. Thus, the report describes exclusion criteria for defining the scope of radiological protection regulations, exemption criteria for planned exposure situations, and the application of these concepts in emergency exposure situations and in existing exposure situations. The report also addresses specific exposure situations such as exposure to low-energy or low-intensity adventitious radiation, cosmic radiation, naturally occurring radioactive materials, radon, commodities, and low-level radioactive waste. The quantitative criteria in the report are intended only as generic suggestions to regulators for defining the regulatory scope, in the understanding that the definitive boundaries for establishing the situations that can be or need to be regulated will depend on national approaches.
© 2008 ICRP. Published by Elsevier Ltd. All rights reserved.
Keywords: Exclusion; Exemption; Radiological protection; Clearance; Regulation.
Key Points: Not included in this publication
Executive Summary
(a) This report offers advice to competent national authorities and relevant intergovernmental organisations for facilitating their definition of the scope of control measures for purposes of protecting people against possible adverse consequences of radiation exposure. As control measures are usually implemented through regulations, the report indirectly provides advice on the scope of radiological protection regulations. While the Commission’s recommendations for radiological protection are not limited in extent, regulations need to be limited in their reach for legal and practical reasons. Since the recommendations are widely used in the formulation of regulations, they influence the definition of the regulatory scope. The relevant basic principles of the recommendations are the justification and optimisation of control measures, within constrained individual doses, and they provide the basis for the advice offered in the report. Such advice should not be construed as interfering with the sovereignty of national legislation and the indispensable rights of the national regulators for establishing the scope of radiological protection control measures.
(b) The main concepts associated with the scope of radiological protection regulations are termed ‘exclusion’ and ‘exemption’. Exclusion refers to the deliberate omission of exposure situations from the scope of regulatory requirements, and exemption refers to waiving regulatory requirements if their application is not warranted. A special case of exemption, termed ‘clearance’, refers to the relinquishing of regulatory control if such control becomes unwarranted.
(c) The definition of scope can differ according to the various types of radiation exposure situation. The relevant situations to consider are: ‘planned exposure situations’, which are situations involving the deliberate introduction and operation of radiation sources; ‘emergency exposure situations’, which are situations that may occur during the operation of a planned situation, or from a malicious act, or from any other unexpected situation, and which require urgent action in order to avoid or reduce undesirable consequences; and ‘existing exposure situations’, which are exposure situations that already exist when a decision on control has to be taken, including prolonged exposure situations that result from radioactive residues that may remain in the long term after emergencies. Planned exposure situations are normally within the scope of regulatory requirements for radiological protection and, therefore, the concepts of exclusion, exemption, and clearance may be used to justify and optimise regulatory control by avoiding the application of unamenable or unwarranted control measures. Conversely, in emergency exposure situations the concepts of exclusion, exemption, and clearance do not play a meaningful role; however, prolonged exposure situations remaining in the long term after math of an emergency exposure situation may be treated as a de-facto existing exposure situation. Many existing exposure situations fall outside the scope of regulatory requirements because the criteria for exclusion are met; however, regulatory controls may be required when it is considered that they are justified and warranted.
(d) Societal attitudes to the control of exposure situations may vary and be dichotomous. Usually, people have higher demands for controlling ‘artificial’ exposure situations than for dealing with ‘natural’ exposure situations. When dealing with natural radioactivity, determining whether or not a given situation should be subjected to radiation protection requirements is particularly complex. However, natural sources of exposure should, in principle, be controlled coherently and consistently with other sources regardless of their origin or magnitude. Nevertheless, account should be taken not only of the justification and optimisation of controlling measures, but also of the different expectations of those affected by the exposure situations.
(e) Depending on the relevant national regulatory systems, legislators or regulators should consider application of the concept of ‘exclusion’ to any exposure situation that is considered to be either uncontrollable or unamenable to control through regulation. These comprise many exposures arising from the natural environment, including exposures from cosmic radiation at ground level and from natural radioactive constituents of the human body. They may also include radioactive residues from past activities and events, and radioactive releases that were lawfully discharged to the environment from regulated human activity, but which may have become unamenable to further control. The concept of exclusion may also be considered for application to raw material extracted from the ground that contains radionuclides of natural origin in concentrations below a specified value.
(f) For planned exposure situations, radiological protection regulations should provide for the application of the concept of ‘exemption’ from specified regulatory requirements. Exemption allows regulators to release legal persons (which include natural persons with legal capacity) from compliance with specified requirements if they judge that the application of such requirements is unwarranted. The Commission recommends that exemption may be granted only if the following conditions are met: individual radiation risks to be incurred by those exposed must be acceptably small; protection must be considered to be optimised; there must not be appreciable likelihood of unintended scenarios that could lead to a failure to meet the previous conditions; and the legal persons to be exempted must be conducting activities that are considered to be justified. Materials or sites subject to regulatory requirements, but for which regulatory requirements have become unwarranted, can be exempted through the application of the concept of ‘clearance’. Regulatory control is relinquished upon clearance. The criteria for clearance should ensure that relinquishing control must, at least, not lead to an exposure situation that would fail to meet any of the conditions for exemption.
(g) For situations involving artificial sources of radiation, an individual dose criterion of approximately 10 µSv/year has been widely used for the purposes of exemption without further consideration. However, this should not be taken to be the sole criterion for granting exemption. It is the principle of optimisation rather than just the triviality of individual doses that should be considered as the basis for exemption. For situations involving radionuclides of natural origin, the national authority may establish levels for the purposes of exemption that are consistent with exemption being the optimum regulatory option.
(h) Agreements on generically derived exemption and clearance levels are being reached under the aegis of international intergovernmental organisations. They are expressed in terms of the following quantities: activity of a source at any one time; activity concentration in low amounts of material; activity concentration, irrespective of the amount of material, in a given situation or for unrestricted release; and activity or activity concentration of transported materials, irrespective of the amount, while the material is in transport. The Commission neither specifically endorses nor disapproves the use of these levels, but considers that this type of consensual intergovernmental generic guidance is very useful for purposes of international standardisation. While exemption levels are basically to be decided by national regulators, the use of those levels being developed under the aegis of competent international intergovernmental organisations should be encouraged. These generic levels, which seem to be widely accepted, should promote international coherence and consistency in matters of regulatory scope.
(i) For emergency exposure situations, the concepts of exclusion and exemption do not have a meaningful role. However, authorities responsible for emergency management may specify circumstances under which no emergency protective actions would be justified and warranted; but this would depend on optimisation of the protective strategy according to the specific situation. Prolonged exposure situations caused by radioactive residues remaining in the long-term aftermath of an emergency may be treated as a special case of an existing exposure situation.
(j) For existing exposure situations, the definition of scope should address whether or not the extant exposure is high enough for regulatory intervention to be justified, and whether the justified control measures are warranted or the protection is already optimised. The issue therefore is not whether or not regulations are justified or the expected increase in exposure is large enough to warrant the application of regulatory requirements (as in the case of planned exposure situations). Many existing exposure situations involving natural radiation and radioactive materials may be either excluded from the regulatory scope on the basis that regulation is not justified, or exempted from the application of regulatory requirements that are not deemed to be warranted. In these situations, regulations or their application would not be expected to lead to an improvement in protection sufficient to offset the societal efforts and possible detriment arising from regulatory enforcement and implementation. However, in some situations, regulations may specify levels defining a type of non-action ceiling above which some regulatory requirements would apply. For the existing exposure situations that may remain in the long-term aftermath following an emergency, consideration should be given to specifying optimum levels of activity of residual radioactive material above which regulatory requirements would apply to the legal person responsible for remediation. For levels corresponding to a residual annual dose of the order of 1 mSv and higher, control measures are likely to be justified, but higher or lower values may be appropriate in particular circumstances.
(k) For adventitious exposure to low-energy or low-intensity external exposure, some sources may be considered as candidates for exemption without further consideration. Apparatus and devices emitting radiation that are of a type approved by the regulator may be exempted if they meet the following criteria: (i) in normal operating conditions, they do not exceed an effective dose criterion that corresponds to an ambient dose equivalent rate or a directional dose equivalent rate, as appropriate, exceeding approximately 1 µSv/h at a distance of 0.1 m from any accessible surface of the apparatus or device; or (ii) the maximum energy of the emitted radiation is no greater than approximately 5 keV. Similarly, apparatus and devices containing radioactive material that are of a type approved by the national authority, and are not otherwise exempted, may be exempted provided that:
(i) the radioactive material is in the form of a sealed source that effectively prevents leakage and direct contact with the material, and, (ii) in normal operating conditions, does not exceed an effective dose criterion that corresponds to an ambient dose equivalent rate or a directional dose equivalent rate, as appropriate, exceeding approximately 1 µSv/h at a distance of 0.1 m from any accessible surface of the apparatus or device.
(l) For regular exposure situations to cosmic radiation above the earth’s surface, such as in air travel, there seems to be no obvious reason to recommend additional regulatory controls to those already in place. National authorities may wish to monitor these situations until more information becomes available. Exceptional cases of cosmic radiation exposure, such as exposure in space travel, where doses may be significant and some type of control warranted, should be dealt with separately, taking into account the special type of situations that can give rise to this type of exposure. (m) For exposure situations involving specified processed materials and by-products containing radionuclides of natural origin, consideration may be given to extending the use of exclusion beyond the case of raw materials, whenever their regulation is unjustified and should the legal national conditions permit. In jurisdictions where the mechanism of exclusion may not be appropriate, the concept of exemption may be applied to these products in order to achieve an equivalent objective. International intergovernmental organisations have developed guidance on criteria for exclusion and exemption in such exposure situations.
(n) For exposure situations to radon in buildings and workplaces, levels of activity concentration should be specified for which protection is considered to be optimised. Above these levels, controlling measures should be applied. (Such levels would therefore serve a different purpose from the reference levels recommended by the Commission, which delineate a dose level above which it is judged to be inappropriate to plan to allow exposures to occur, and below which optimisation of protection should be implemented.) In the case of workplaces, a single concentration value may continue to be used; this has been established through intergovernmental harmonisation for triggering the application of monitoring requirements for occupational radiological protection.
(o) For commodities containing small amounts of radionuclides, international intergovernmental organisations have developed radiological criteria applicable to international trade. These criteria cover non-edible commodities, foodstuffs, and drinking water. Again, these generic levels seem to be widely accepted, and should promote global coherence and consistency, and facilitate international trade.
(p) Whatever regulatory mechanisms are employed to address the different types of exposure situation, the recommendations in this report are intended to assist in defining what can be or needs to be the subject of regulatory requirements for radiological protection and, conversely, what does not. The application of regulatory control should achieve a net benefit in protection; otherwise, regulatory control is not justified. Similarly, regulatory requirements should be applied in a manner that optimises protection; otherwise, the application of regulatory requirements would not be warranted. Application of the concepts of exclusion and exemption, including clearance, can lead to regulatory systems that are justified and optimised for each exposure situation.
ICRP, 2007. Scope of Radiological Protection Control Measures. ICRP Publication 104. Ann. ICRP 37 (5).
Abstract - In this report, the Commission recommends approaches to national authorities for their definition of the scope of radiological protection control measures through regulations, by using its principles of justification and optimisation. The report provides advice for deciding the radiation exposure situations that should be covered by the relevant regulations because their regulatory control can be justified, and, conversely, those that may be considered for exclusion from the regulations because their regulatory control is deemed to be unamenable and unjustified. It also provides advice on the situations resulting from regulated circumstances but which may be considered by regulators for exemption from complying with specific requirements because the application of these requirements is unwarranted and exemption is the optimum option. Thus, the report describes exclusion criteria for defining the scope of radiological protection regulations, exemption criteria for planned exposure situations, and the application of these concepts in emergency exposure situations and in existing exposure situations. The report also addresses specific exposure situations such as exposure to low-energy or low-intensity adventitious radiation, cosmic radiation, naturally occurring radioactive materials, radon, commodities, and low-level radioactive waste. The quantitative criteria in the report are intended only as generic suggestions to regulators for defining the regulatory scope, in the understanding that the definitive boundaries for establishing the situations that can be or need to be regulated will depend on national approaches.
© 2008 ICRP. Published by Elsevier Ltd. All rights reserved.
Keywords: Exclusion; Exemption; Radiological protection; Clearance; Regulation.
Key Points: Not included in this publication
Executive Summary
(a) This report offers advice to competent national authorities and relevant intergovernmental organisations for facilitating their definition of the scope of control measures for purposes of protecting people against possible adverse consequences of radiation exposure. As control measures are usually implemented through regulations, the report indirectly provides advice on the scope of radiological protection regulations. While the Commission’s recommendations for radiological protection are not limited in extent, regulations need to be limited in their reach for legal and practical reasons. Since the recommendations are widely used in the formulation of regulations, they influence the definition of the regulatory scope. The relevant basic principles of the recommendations are the justification and optimisation of control measures, within constrained individual doses, and they provide the basis for the advice offered in the report. Such advice should not be construed as interfering with the sovereignty of national legislation and the indispensable rights of the national regulators for establishing the scope of radiological protection control measures.
(b) The main concepts associated with the scope of radiological protection regulations are termed ‘exclusion’ and ‘exemption’. Exclusion refers to the deliberate omission of exposure situations from the scope of regulatory requirements, and exemption refers to waiving regulatory requirements if their application is not warranted. A special case of exemption, termed ‘clearance’, refers to the relinquishing of regulatory control if such control becomes unwarranted.
(c) The definition of scope can differ according to the various types of radiation exposure situation. The relevant situations to consider are: ‘planned exposure situations’, which are situations involving the deliberate introduction and operation of radiation sources; ‘emergency exposure situations’, which are situations that may occur during the operation of a planned situation, or from a malicious act, or from any other unexpected situation, and which require urgent action in order to avoid or reduce undesirable consequences; and ‘existing exposure situations’, which are exposure situations that already exist when a decision on control has to be taken, including prolonged exposure situations that result from radioactive residues that may remain in the long term after emergencies. Planned exposure situations are normally within the scope of regulatory requirements for radiological protection and, therefore, the concepts of exclusion, exemption, and clearance may be used to justify and optimise regulatory control by avoiding the application of unamenable or unwarranted control measures. Conversely, in emergency exposure situations the concepts of exclusion, exemption, and clearance do not play a meaningful role; however, prolonged exposure situations remaining in the long term after math of an emergency exposure situation may be treated as a de-facto existing exposure situation. Many existing exposure situations fall outside the scope of regulatory requirements because the criteria for exclusion are met; however, regulatory controls may be required when it is considered that they are justified and warranted.
(d) Societal attitudes to the control of exposure situations may vary and be dichotomous. Usually, people have higher demands for controlling ‘artificial’ exposure situations than for dealing with ‘natural’ exposure situations. When dealing with natural radioactivity, determining whether or not a given situation should be subjected to radiation protection requirements is particularly complex. However, natural sources of exposure should, in principle, be controlled coherently and consistently with other sources regardless of their origin or magnitude. Nevertheless, account should be taken not only of the justification and optimisation of controlling measures, but also of the different expectations of those affected by the exposure situations.
(e) Depending on the relevant national regulatory systems, legislators or regulators should consider application of the concept of ‘exclusion’ to any exposure situation that is considered to be either uncontrollable or unamenable to control through regulation. These comprise many exposures arising from the natural environment, including exposures from cosmic radiation at ground level and from natural radioactive constituents of the human body. They may also include radioactive residues from past activities and events, and radioactive releases that were lawfully discharged to the environment from regulated human activity, but which may have become unamenable to further control. The concept of exclusion may also be considered for application to raw material extracted from the ground that contains radionuclides of natural origin in concentrations below a specified value.
(f) For planned exposure situations, radiological protection regulations should provide for the application of the concept of ‘exemption’ from specified regulatory requirements. Exemption allows regulators to release legal persons (which include natural persons with legal capacity) from compliance with specified requirements if they judge that the application of such requirements is unwarranted. The Commission recommends that exemption may be granted only if the following conditions are met: individual radiation risks to be incurred by those exposed must be acceptably small; protection must be considered to be optimised; there must not be appreciable likelihood of unintended scenarios that could lead to a failure to meet the previous conditions; and the legal persons to be exempted must be conducting activities that are considered to be justified. Materials or sites subject to regulatory requirements, but for which regulatory requirements have become unwarranted, can be exempted through the application of the concept of ‘clearance’. Regulatory control is relinquished upon clearance. The criteria for clearance should ensure that relinquishing control must, at least, not lead to an exposure situation that would fail to meet any of the conditions for exemption.
(g) For situations involving artificial sources of radiation, an individual dose criterion of approximately 10 µSv/year has been widely used for the purposes of exemption without further consideration. However, this should not be taken to be the sole criterion for granting exemption. It is the principle of optimisation rather than just the triviality of individual doses that should be considered as the basis for exemption. For situations involving radionuclides of natural origin, the national authority may establish levels for the purposes of exemption that are consistent with exemption being the optimum regulatory option.
(h) Agreements on generically derived exemption and clearance levels are being reached under the aegis of international intergovernmental organisations. They are expressed in terms of the following quantities: activity of a source at any one time; activity concentration in low amounts of material; activity concentration, irrespective of the amount of material, in a given situation or for unrestricted release; and activity or activity concentration of transported materials, irrespective of the amount, while the material is in transport. The Commission neither specifically endorses nor disapproves the use of these levels, but considers that this type of consensual intergovernmental generic guidance is very useful for purposes of international standardisation. While exemption levels are basically to be decided by national regulators, the use of those levels being developed under the aegis of competent international intergovernmental organisations should be encouraged. These generic levels, which seem to be widely accepted, should promote international coherence and consistency in matters of regulatory scope.
(i) For emergency exposure situations, the concepts of exclusion and exemption do not have a meaningful role. However, authorities responsible for emergency management may specify circumstances under which no emergency protective actions would be justified and warranted; but this would depend on optimisation of the protective strategy according to the specific situation. Prolonged exposure situations caused by radioactive residues remaining in the long-term aftermath of an emergency may be treated as a special case of an existing exposure situation.
(j) For existing exposure situations, the definition of scope should address whether or not the extant exposure is high enough for regulatory intervention to be justified, and whether the justified control measures are warranted or the protection is already optimised. The issue therefore is not whether or not regulations are justified or the expected increase in exposure is large enough to warrant the application of regulatory requirements (as in the case of planned exposure situations). Many existing exposure situations involving natural radiation and radioactive materials may be either excluded from the regulatory scope on the basis that regulation is not justified, or exempted from the application of regulatory requirements that are not deemed to be warranted. In these situations, regulations or their application would not be expected to lead to an improvement in protection sufficient to offset the societal efforts and possible detriment arising from regulatory enforcement and implementation. However, in some situations, regulations may specify levels defining a type of non-action ceiling above which some regulatory requirements would apply. For the existing exposure situations that may remain in the long-term aftermath following an emergency, consideration should be given to specifying optimum levels of activity of residual radioactive material above which regulatory requirements would apply to the legal person responsible for remediation. For levels corresponding to a residual annual dose of the order of 1 mSv and higher, control measures are likely to be justified, but higher or lower values may be appropriate in particular circumstances.
(k) For adventitious exposure to low-energy or low-intensity external exposure, some sources may be considered as candidates for exemption without further consideration. Apparatus and devices emitting radiation that are of a type approved by the regulator may be exempted if they meet the following criteria: (i) in normal operating conditions, they do not exceed an effective dose criterion that corresponds to an ambient dose equivalent rate or a directional dose equivalent rate, as appropriate, exceeding approximately 1 µSv/h at a distance of 0.1 m from any accessible surface of the apparatus or device; or (ii) the maximum energy of the emitted radiation is no greater than approximately 5 keV. Similarly, apparatus and devices containing radioactive material that are of a type approved by the national authority, and are not otherwise exempted, may be exempted provided that:
(i) the radioactive material is in the form of a sealed source that effectively prevents leakage and direct contact with the material, and, (ii) in normal operating conditions, does not exceed an effective dose criterion that corresponds to an ambient dose equivalent rate or a directional dose equivalent rate, as appropriate, exceeding approximately 1 µSv/h at a distance of 0.1 m from any accessible surface of the apparatus or device.
(l) For regular exposure situations to cosmic radiation above the earth’s surface, such as in air travel, there seems to be no obvious reason to recommend additional regulatory controls to those already in place. National authorities may wish to monitor these situations until more information becomes available. Exceptional cases of cosmic radiation exposure, such as exposure in space travel, where doses may be significant and some type of control warranted, should be dealt with separately, taking into account the special type of situations that can give rise to this type of exposure. (m) For exposure situations involving specified processed materials and by-products containing radionuclides of natural origin, consideration may be given to extending the use of exclusion beyond the case of raw materials, whenever their regulation is unjustified and should the legal national conditions permit. In jurisdictions where the mechanism of exclusion may not be appropriate, the concept of exemption may be applied to these products in order to achieve an equivalent objective. International intergovernmental organisations have developed guidance on criteria for exclusion and exemption in such exposure situations.
(n) For exposure situations to radon in buildings and workplaces, levels of activity concentration should be specified for which protection is considered to be optimised. Above these levels, controlling measures should be applied. (Such levels would therefore serve a different purpose from the reference levels recommended by the Commission, which delineate a dose level above which it is judged to be inappropriate to plan to allow exposures to occur, and below which optimisation of protection should be implemented.) In the case of workplaces, a single concentration value may continue to be used; this has been established through intergovernmental harmonisation for triggering the application of monitoring requirements for occupational radiological protection.
(o) For commodities containing small amounts of radionuclides, international intergovernmental organisations have developed radiological criteria applicable to international trade. These criteria cover non-edible commodities, foodstuffs, and drinking water. Again, these generic levels seem to be widely accepted, and should promote global coherence and consistency, and facilitate international trade.
(p) Whatever regulatory mechanisms are employed to address the different types of exposure situation, the recommendations in this report are intended to assist in defining what can be or needs to be the subject of regulatory requirements for radiological protection and, conversely, what does not. The application of regulatory control should achieve a net benefit in protection; otherwise, regulatory control is not justified. Similarly, regulatory requirements should be applied in a manner that optimises protection; otherwise, the application of regulatory requirements would not be warranted. Application of the concepts of exclusion and exemption, including clearance, can lead to regulatory systems that are justified and optimised for each exposure situation.
