/Docs/OTF/org/iaea/GSR3/0.md
Document views: Document Xray Visual Cicero Print   Source views: Source OpenParameters JSON(ish)   On GitHub: File ~PageRank   (rare: 'ShowMe' 1)
{MessageToUser} GUID: {Doc.GUID}

IAEA Safety Standards Series No. GSR Part 3, Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards


  1. INTRODUCTION
    • BACKGROUND
      1. This General Safety Requirements publication, IAEA Safety Standards Series No. GSR Part 3, Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards (hereinafter referred to as ‘these Standards’), is issued in the IAEA Safety Standards Series. It supersedes International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources issued in 1996 (the ‘BSS of 1996’)1. Section 1 does not include requirements, but explains the context, concepts and principles for the requirements, which are established in Sections 2–5 and in the schedules.
      2. Radioactivity is a natural phenomenon and natural sources of radiation are features of the environment. Radiation2 and radioactive material may also be of artificial origin and they have many beneficial applications, including uses in medicine, industry, agriculture and research as well as for nuclear power generation. The radiation risks to people and the environment that may arise from the use of radiation and radioactive material must be assessed and must be controlled by means of the application of standards of safety3.
      3. Exposure of human tissues or organs to radiation can induce the death of cells on a scale that can be extensive enough to impair the function of the exposed tissue or organ. Effects of this type, which are called ‘deterministic effects’, are clinically observable in an individual only if the radiation dose exceeds a certain threshold level. Above this threshold level of dose, a deterministic effect is more severe for a higher dose.
      4. Exposure to radiation can also induce the non-lethal transformation of cells, which may still retain their capacity for cell division. The human body’s immune system is very effective at detecting and destroying abnormal cells. However, there is a possibility that the non-lethal transformation of a cell could lead, after a latency period, to cancer in the individual exposed, if the cell is a somatic cell; or such a transformation of a cell could lead to hereditary effects, if the cell is a germ cell. Such effects are called ‘stochastic’ effects. For the purposes of these Standards, it is assumed that the probability of the eventual occurrence of a stochastic effect is proportional to the dose received, with no threshold. The ‘detriment-adjusted nominal risk coefficient of dose’, which includes the risks of all cancers and the risks of hereditary effects, is 5% per sievert [2]. This risk coefficient may need to be adjusted as new scientific knowledge becomes available.
      5. The requirements established in these Standards are governed by the objectives, concepts and principles of the Fundamental Safety Principles [1]. These Standards draw upon information derived from the experience of States in applying the requirements of the BSS of 1996 4 , and from experience in many States in the use of radiation and nuclear techniques. These Standards draw upon extensive research and development work by national and international scientific and engineering organizations on the health effects of radiation exposure and on measures and techniques for the safe design and use of radiation sources. These Standards also take account of the findings of the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) [3] and the Recommendations of the International Commission on Radiological Protection (ICRP) [2]. As scientific considerations are only part of the basis for making decisions on protection and safety, these Standards also address the use of value judgements relating to the management of risks.
      • The system of protection and safety
        1. As stated in the Fundamental Safety Principles [1], “The fundamental safety objective is to protect people and the environment from harmful effects of ionizing radiation.” This objective must be achieved without unduly limiting the operation of facilities or the conduct of activities that give rise to radiation risks5. Therefore, the system of protection and safety aims to assess, manage and control exposure to radiation so that radiation risks, including risks of health effects and risks to the environment, are reduced to the extent reasonably achievable.
        2. These Standards are based on the following safety principles stated in the Fundamental Safety Principles [1]:
          • Principle 1: Responsibility for safety
            The prime responsibility for safety must rest with the person or organization responsible for facilities and activities that give rise to radiation risks.
          • Principle 2: Role of government
            An effective legal and governmental framework for safety, including an independent regulatory body, must be established and sustained.
          • Principle 3: Leadership and management for safety
            Effective leadership and management for safety must be established and sustained in organizations concerned with, and facilities and activities that give rise to, radiation risks.
          • Principle 4: Justification of facilities and activities
            Facilities and activities that give rise to radiation risks must yield an overall benefit.
          • Principle 5: Optimization of protection
            Protection must be optimized to provide the highest level of safety that can reasonably be achieved.
          • Principle 6: Limitation of risks to individuals
            Measures for controlling radiation risks must ensure that no individual bears an unacceptable risk of harm.
          • Principle 7: Protection of present and future generations
            People and the environment, present and future, must be protected against radiation risks.
          • Principle 8: Prevention of accidents
            All practical efforts must be made to prevent and mitigate nuclear or radiation accidents.
          • Principle 9: Emergency preparedness and response
            Arrangements must be made for emergency preparedness and response for nuclear or radiation incidents.
          • Principle 10: Protective actions to reduce existing or unregulated radiation risks
            Protective actions to reduce existing or unregulated radiation risks must be justified and optimized.
        3. The prime responsibility for safety must rest with the person or organization responsible for facilities and activities6 that give rise to radiation risks [1]. Other parties also bear certain responsibilities. For instance, suppliers of radiation generators and radioactive sources have responsibilities in relation to their design and manufacture and operating instructions for their safe use. In the case of medical exposures, because of the medical setting in which such exposures occur, primary responsibility for protection and safety for patients lies with the health professional responsible for administration of the radiation dose, who is referred to in these Standards as the ‘radiological medical practitioner’. Other types of health professional may be involved in the preparation for, and the conduct of, radiological procedures, and each type has specific responsibilities, as established in these Standards.
        4. A properly established governmental, legal and regulatory framework for safety provides for the regulation of facilities and activities that give rise to radiation risks. There is a hierarchy of responsibilities within this framework, from governments to regulatory bodies to the organizations responsible for, and the persons engaged in, activities involving radiation exposure. The government is responsible for the adoption within its national legal system of such legislation, regulations, and standards and measures as may be necessary to fulfil all its national and international obligations effectively, and for the establishment of an independent regulatory body. In some cases, more than one governmental organization may have the functions of a regulatory body for activities within their jurisdictions relating to the control of radiation and radioactive material.
        5. Both the government and the regulatory body have important responsibilities in establishing the regulatory framework for protecting people and the environment from harmful effects of radiation, including establishing standards. These Standards require the government to ensure that there is coordination of government departments and agencies that have responsibilities for protection and safety, including the regulatory body, and of departments and agencies concerned with public health, the environment, labour, mining, science and technology, agriculture and education. Standards have to be developed by means of consultation with those who are or who could be required to apply them.
        6. The government is also responsible for ensuring, as necessary, that provision is made for support services, such as education and training, and technical services. If these services are not available within the State, other mechanisms to provide them may have to be considered. The regulatory body is responsible for carrying out its required regulatory functions, such as the establishment of requirements and guidelines, the authorization and inspection of facilities and activities, and the enforcement of legislative and regulatory provisions.
        7. Leadership in safety matters has to be demonstrated at the highest levels in an organization, and safety has to be achieved and maintained by means of an effective management system. This system has to integrate all elements of management so that requirements for protection and safety are established and applied coherently with other requirements, including those for health, human performance, quality, protection of the environment and security, together with economic considerations. The application of the management system also has to ensure the promotion of safety culture, the regular assessment of safety performance and the application of lessons learned from experience. Safety culture includes individual and collective commitment to safety on the part of the leadership, the management and personnel at all levels. The term ‘management system’ reflects and includes the concept of ‘quality control’ (controlling the quality of products) and its evolution through ‘quality assurance’ (the system for ensuring the quality of products) and ‘quality management system’ (the system for managing quality).
        8. The operation of facilities or the conduct of activities that introduce a new source of radiation, that change exposures or that change the likelihood of exposures has to be justified in the sense that the detriments that may be caused are outweighed by the individual and societal benefits that are expected. The comparison of detriments and benefits often goes beyond the consideration of protection and safety, and involves the consideration of economic, societal and environmental factors also.
        9. The application of the justification principle to medical exposures requires a special approach. As an overarching justification of medical exposures, it is accepted that the use of radiation in medicine does more good than harm. However, at the next level, there is a need for generic justification, to be carried out by the health authority in conjunction with appropriate professional bodies, of a given radiological procedure. This applies to the justification of new technologies and techniques as they evolve. For the final level of justification, the application of the radiological procedure to a given individual has to be considered. The specific objectives of the exposure, the clinical circumstances and the characteristics of the individual involved have to be taken into account by means of referral guidelines developed by professional bodies and the health authority.
        10. The optimization of protection and safety, when applied to the exposure of workers and members of the public, and carers and comforters of patients undergoing radiological procedures, is a process for ensuring that the likelihood and magnitude of exposures and the number of individuals exposed are as low as reasonably achievable, with economic, societal and environmental factors taken into account. This means that the level of protection would be the best possible under the prevailing circumstances. Optimization is a prospective and iterative process that requires both qualitative and quantitative judgements to be made.
        11. As is the case with justification, the application of the optimization principle to the medical exposure of patients, and to that of volunteers as part of a programme of biomedical research, requires a special approach. Too low a radiation dose could be as bad as too high a radiation dose, in that the consequence could be that a cancer is not cured or the images obtained are not of suitable diagnostic quality. It is of paramount importance that the medical exposure leads to the required outcome.
        12. For planned exposure situations, exposures and risks are subject to control to ensure that the specified dose limits for occupational exposure and those for public exposure are not exceeded, and optimization is applied to attain the desired level of protection and safety.
        13. All practical efforts must be made to prevent and mitigate nuclear or radiological accidents. The most harmful consequences arising from facilities and activities have come from the loss of control over a nuclear reactor core, nuclear chain reaction, radioactive source or other source of radiation. Consequently, to ensure that the likelihood of an accident having harmful consequences is extremely low, measures have to be taken:
          • — To prevent the occurrence of failures or abnormal conditions (including breaches of security) that could lead to such a loss of control;
          • — To prevent the escalation of any such failures or abnormal conditions that do occur;
          • — To prevent the loss of, or the loss of control over, a radioactive source or other source of radiation.
        14. Arrangements must be made for emergency preparedness and response for nuclear or radiological incidents. The primary goals of preparedness and response for a nuclear or radiological emergency are:
          • — To ensure that arrangements are in place for an effective response at the scene and, as appropriate, at the local, regional, national and international levels, to a nuclear or radiation emergency;
          • — To ensure that, for reasonably foreseeable incidents, radiation risks would be minor;
          • — For any incidents that do occur, to take practical measures to mitigate any consequences for human life and health and the environment.
      • Types of exposure situation
        1. For the purpose of establishing practical requirements for protection and safety, these Standards distinguish between three different types of exposure situation: planned exposure situations, emergency exposure situations and existing exposure situations [2]. Together, these three types of exposure situation cover all situations of exposure for which these Standards apply:
          1. A planned exposure situation is a situation of exposure that arises from the planned operation of a source or from a planned activity that results in an exposure due to a source. Since provision for protection and safety can be made before embarking on the activity concerned, the associated exposures and their likelihood of occurrence can be restricted from the outset. The primary means of controlling exposure in planned exposure situations is by good design of facilities, equipment and operating procedures, and by training. In planned exposure situations, exposure at some level can be expected to occur. If exposure is not expected to occur with certainty, but could result from an accident or from an event or a sequence of events that may occur but is not certain to occur, this is referred to as ‘potential exposure’.
          2. An emergency exposure situation is a situation of exposure that arises as a result of an accident, a malicious act or any other unexpected event, and requires prompt action in order to avoid or to reduce adverse consequences. Preventive measures and mitigatory actions have to be considered before an emergency exposure situation arises. However, once an emergency exposure situation actually arises, exposures can be reduced only by implementing protective actions.
          3. An existing exposure situation is a situation of exposure that already exists when a decision on the need for control needs to be taken. Existing exposure situations include situations of exposure to natural background radiation. They also include situations of exposure due to residual radioactive material that derives from past practices that were not subject to regulatory control or that remains after an emergency exposure situation.
          If an event or a sequence of events that has been considered in the assessment of potential exposure does actually occur, it may be treated either as a planned exposure situation or, if an emergency has been declared, as an emergency exposure situation.
        2. The descriptions that are given in para. 1.20 of the three types of exposure situation are not always sufficient to determine unequivocally which type of exposure situation applies for particular circumstances. For instance, the transitions from an emergency exposure situation to an existing exposure situation may occur progressively over time; and some exposures due to natural sources may have some characteristics of both planned exposure situations and existing exposure situations. In these Standards, the most appropriate type of exposure situation for particular circumstances has been determined by taking practical considerations into account. For the purposes of these Standards, the exposure of aircrew to cosmic radiation is considered under existing exposure situations in Section 5. The exposure of space crew to cosmic radiation presents exceptional circumstances and these are considered separately in Section 5.
      • Dose constraints and reference levels
        1. Dose constraints and reference levels are used for optimization of protection and safety, the intended outcome of which is that all exposures are controlled to levels that are as low as reasonably achievable, economic, societal and environmental factors being taken into account. Dose constraints are applied to occupational exposure and to public exposure in planned exposure situations. Dose constraints are set separately for each source under control and they serve as boundary conditions in defining the range of options for the purposes of optimization of protection and safety. Dose constraints are not dose limits: exceeding a dose constraint does not represent non-compliance with regulatory requirements, but it could result in follow-up actions.
        2. While the objectives of the use of dose constraints for controlling occupational exposure and public exposure are similar, the dose constraints are applied in different ways. For occupational exposure, the dose constraint is a tool to be established and used in the optimization of protection and safety by the person or organization responsible for a facility or an activity. For public exposure in planned exposure situations, the government or the regulatory body ensures the establishment or approval of dose constraints, taking into account the characteristics of the site and of the facility or activity, the scenarios for exposure and the views of interested parties. After exposures have occurred, the dose constraint may be used as a benchmark for assessing the suitability of the optimized strategy for protection and safety (referred to as the protection strategy) that has been implemented and for making adjustments as necessary. The setting of the dose constraint needs to be considered in conjunction with other health and safety provisions and the technology available.
        3. Reference levels are used for optimization of protection and safety in emergency exposure situations and in existing exposure situations. They are established or approved by the government, the regulatory body or another relevant authority. For occupational exposure and public exposure in emergency exposure situations and in existing exposure situations, a reference level serves as a boundary condition in identifying the range of options for the purposes of optimization in implementing protective actions. The reference level represents the level of dose or the level of risk above which it is judged to be inappropriate to plan to allow exposures to occur, and below which the optimization of protection and safety is implemented. The value chosen for the reference level will depend on the prevailing circumstances for the exposures under consideration. The optimized protection strategies are intended to keep doses below the reference level. When an emergency exposure situation has arisen or an existing exposure situation has been identified, actual exposures could be above or below the reference level. The reference level would be used as a benchmark for judging whether further protective actions are necessary and, if so, in prioritizing their application. Optimization of protection and safety is to be applied in emergency exposure situations and in existing exposure situations, even if the doses initially received are below the reference level.
        4. The ICRP recommends a range of doses spanning two orders of magnitude within which the value of a dose constraint or reference level would usually be chosen [2]. At the lower end of this range, the dose constraint or reference level represents an increase, of up to about 1 mSv, over the dose received in a year from exposure due to naturally occurring radiation sources7. It would be used when individuals are exposed to radiation from a source that yields little or no benefit for them, but which may benefit society in general. This would be the case, for instance, in establishing dose constraints for public exposure in planned exposure situations.
        5. Dose constraints or reference levels of 1–20 mSv would be used when the exposure situation — but not necessarily the exposure itself — usually benefits individuals. This would be the case, for instance, when establishing dose constraints for occupational exposure in planned exposure situations or reference levels for exposure of a member of the public in existing exposure situations.
        6. Reference levels of 20–100 mSv would be used where individuals are exposed to radiation from sources that are not under control or where actions to reduce doses would be disproportionately disruptive. This would be the case, for instance, in establishing reference levels for the residual dose after a nuclear or radiological emergency. Any situation that resulted in a dose of greater than 100 mSv being incurred within a short period of time or in one year would be considered unacceptable, except under the circumstances relating to exposure of emergency workers that are addressed specifically in these Standards.
        7. The selection of the value for the dose constraint or the reference level would be based on the characteristics of the exposure situation, including:
          • — The nature of the exposure and the practicability of reducing or preventing the exposure;
          • — The expected benefits of the exposure for individuals and society, or the benefits of avoiding preventive measures or protective actions that would be detrimental to living conditions, as well as other societal criteria relating to the management of the exposure situation;
          • — National or regional factors, together with a consideration of international guidance and good practice elsewhere.
        8. The system of protection and safety required by these Standards includes criteria for protection against exposure due to radon that are based on the average level of risk to a population with typical but various smoking habits. Owing to the synergistic effects of smoking and exposure due to radon, the absolute risk of lung cancer resulting from unit dose from exposure due to radon for people who are smokers is substantially greater than for those who have never smoked [3, 5, 6]. Information provided to people on the risks associated with exposure due to radon needs to highlight this increased risk for smokers.
        9. Dose constraints are used in optimization of protection and safety for carers and comforters and for volunteers subject to exposure as part of a programme of biomedical research. Dose constraints are not applicable to the exposure of patients in radiological procedures for the purposes of medical diagnosis or treatment.
        10. In X ray medical imaging, image guided interventional procedures and diagnostic nuclear medicine, a diagnostic reference level is used to indicate the need for an investigation. Periodic assessments are performed of typical doses or activity of the radiopharmaceuticals administered in a medical facility. If comparison with established diagnostic reference levels shows that the typical doses or activity of the radiopharmaceuticals administered are either too high or unusually low, a local review is to be initiated to ascertain whether protection and safety has been optimized and whether any corrective action is required.
      • Protection of the environment
        1. In a global and long term perspective, protection of people and the environment against radiation risks associated with the operation of facilities and the conduct of activities — and in particular, protection against such risks that may transcend national borders and may persist for long periods of time — is important for achieving equitable and sustainable development.
        2. The system of protection and safety required by these Standards generally provides for appropriate protection of the environment from harmful effects of radiation. Nevertheless, international trends in this field show an increasing awareness of the vulnerability of the environment. Trends also indicate the need to be able to demonstrate (rather than to assume) that the environment is being protected against effects of industrial pollutants, including radionuclides, in a wider range of environmental situations, irrespective of any human connection. This is usually accomplished by means of a prospective environmental assessment to identify impacts on the environment, to define the appropriate criteria for protection of the environment, to assess the impacts and to compare the expected results of the available options for protection. Methods and criteria for such assessments are being developed and will continue to evolve.
        3. Radiological impacts in a particular environment constitute only one type of impact and, in most cases, may not be the dominant impacts of a particular facility or activity. Furthermore, the assessment of impacts on the environment needs to be viewed in an integrated manner with other features of the system of protection and safety to establish the requirements applicable to a particular source. Since there are complex interrelations, the approach to the protection of people and the environment is not limited to the prevention of radiological effects on humans and on other species. When establishing regulations, an integrated perspective has to be adopted to ensure the sustainability, now and in the future, of agriculture, forestry, fisheries and tourism, and of the use of natural resources. Such an integrated perspective also has to take into account the need to prevent unauthorized acts with potential consequences for and via the environment, including, for example, the illicit dumping of radioactive material and the abandonment of radiation sources. Consideration also needs to be given to the potential for buildup and accumulation of long lived radionuclides released to the environment.
        4. These Standards are designed to identify the protection of the environment as an issue necessitating assessment, while allowing for flexibility in incorporating into decision making processes the results of environmental assessments that are commensurate with the radiation risks.
      • Interfaces between safety and security
        1. Safety measures and security measures have in common the aim of protecting human life and health and the environment. In addition, safety measures and security measures must be designed and implemented in an integrated manner, so that security measures do not compromise safety and safety measures do not compromise security.
        2. Security infrastructure and safety infrastructure need to be developed, as far as possible, in a well coordinated manner. All the organizations involved need to be made aware of the commonalities and the differences between safety and security so as to be able to factor both into development plans. The synergies between safety and security have to be developed so that safety and security complement and enhance one another.
    • OBJECTIVE
      1. These Standards establish requirements for the protection of people and the environment from harmful effects of ionizing radiation and for the safety of radiation sources.
    • SCOPE
      1. These Standards apply for protection against ionizing radiation only, which includes gamma rays, X rays and particles such as beta particles, neutrons, protons, alpha particles and heavier ions. While these Standards do not specifically address the control of non-radiological aspects of health, safety and the environment, these aspects also need to be considered. Protection from harmful effects of non-ionizing radiation is outside the scope of these Standards.
      2. These Standards are intended primarily for use by governments and regulatory bodies. Requirements also apply to principal parties and other parties as specified in Section 2, health authorities, professional bodies and service providers such as technical support organizations.
      3. These Standards do not deal with security measures. The IAEA issues recommendations on nuclear security in the IAEA Nuclear Security Series.
      4. These Standards apply to all situations involving radiation exposure that is amenable to control. Exposures deemed to be not amenable to control are excluded from the scope of these Standards.8
      5. These Standards establish requirements to be fulfilled in all facilities and activities giving rise to radiation risks. For certain facilities and activities, such as nuclear installations, radioactive waste management facilities and the transport of radioactive material, other safety requirements, complementary to these Standards, also apply. The IAEA issues Safety Guides to assist in the application of these Standards.
      6. These Standards apply to three categories of exposure: occupational exposure, public exposure and medical exposure.
      7. These Standards apply to human activities involving radiation exposure that are:
        • — Carried out in a State which decides to adopt these Standards or which requests any of the Sponsoring Organizations to provide for the application of these Standards;
        • — Undertaken by States with the assistance of the Food and Agriculture Organization of the United Nations, the IAEA, the International Labour Organization, the Pan American Health Organization, the United Nations Environment Programme or the World Health Organization, in the light of relevant national rules and regulations;
        • — Carried out by the IAEA or involving the use of materials, services, equipment, facilities and non-published information made available by the IAEA or at its request or under its control or supervision; or
        • — Carried out under any bilateral or multilateral arrangement whereby the parties request the IAEA to provide for the application of these Standards.
      8. Quantities and units used in these Standards are in accordance with the recommendations of the International Commission on Radiation Units and Measurements [7].
    • STRUCTURE
      1. The requirements of these Standards are grouped into requirements applicable for all exposure situations and separate sets of requirements for planned exposure situations, emergency exposure situations and existing exposure situations. For each of the three types of exposure situation, the requirements are further grouped into requirements for occupational exposure, public exposure and (for planned exposure situations only) medical exposure.
      2. The requirements established by these Standards, both numbered ‘overarching’ requirements in bold with titles and other requirements, are expressed as ‘shall’ statements. Each individual overarching requirement is followed by associated requirements.
      3. Section 2 sets out the requirements that apply generally for all exposure situations and for all of the three categories of exposure (occupational exposure, public exposure and medical exposure). These requirements include the assignment of responsibilities to the government, the regulatory body, and principal parties and other parties with respect to the implementation of a protection and safety programme and a management system, the promotion of safety culture and the consideration of human factors.
      4. Section 3 sets out the requirements — in addition to those of Section 2 — for planned exposure situations. Section 3 includes requirements applicable to all three categories of exposure, requirements for the safety of sources, and separate sets of requirements in respect of occupational exposure, public exposure and medical exposure.
      5. Section 4 sets out the requirements — in addition to those of Section 2 — for emergency exposure situations. Section 4 includes requirements in respect of public exposure and occupational exposure (i.e. exposure of emergency workers) in emergency exposure situations. It also includes requirements on the transitions from an emergency exposure situation to an existing exposure situation.
      6. Section 5 sets out the requirements — in addition to those of Section 2 — for existing exposure situations. Section 5 includes requirements in respect of public exposure and occupational exposure in existing exposure situations. It includes requirements in respect of remediation of sites and habitation in areas with residual radioactive material, radon in homes and in workplaces, radionuclides in commodities, and exposure of aircrew and of space crew.
      7. The organization of the requirements in these Standards for the relevant categories of exposure in each type of exposure situation is as shown in Table 1. General requirements for all exposure situations are given in Section 2, and requirements for different exposure situations are given in Sections 3–5. Thus, for any particular facility or activity, more than one section of these Standards will be relevant, as illustrated by the following examples:
        1. The requirements for the regulatory body given in Section 2 are applicable for all exposure situations and all categories of exposure. They provide the regulatory framework within which persons or organizations responsible for facilities and activities have to comply with requirements placed on them. These requirements, thus, establish the general regulatory responsibilities of the regulatory body. Any further requirements on the regulatory body that apply for one type of exposure situation are given in Sections 3–5. These further requirements are in addition to the requirements given in Section 2.
          TABLE 1. ORGANIZATION OF THE REQUIREMENTS OF THESE STANDARDS
          Occupational exposurePublic exposureMedical exposure
          Planned exposure situationsSection 2; Section 3: paras 3.5–3.67 and paras 3.68–3.116Section 2; Section 3: paras 3.5–3.67 and paras 3.117–3.144Section 2; Section 3: paras 3.5–3.67 and paras 3.145–3.185
          Emergency exposure situationsSection 2; Section 4Section 2; Section 4Not applicable
          Existing exposure situationsSection 2; Section 5Section 2; Section 5Not applicable
        2. Persons or organizations responsible for a medical facility in which radiation generators or radioactive sources are used are subject to the requirements given in Section 2 for all exposure situations and all categories of exposure, and also to those requirements given in Section 3 that are common to all planned exposure situations (paras 3.5–3.67). In addition, such persons or organizations are subject to the separate requirements given in Section 3 for occupational exposure (such as exposure of medical staff operating medical devices that emit radiation) (paras 3.68–3.116), public exposure (such as exposure in rooms adjacent to rooms containing equipment that generates radiation) (paras 3.117–3.144) and medical exposure (such as exposure of patients) (paras 3.145–3.185).
      8. Schedules I–IV provide numerical values in support of the requirements, covering exemption and clearance, categorization of sealed sources, dose limits for planned exposure situations and criteria for use in emergency preparedness and response.
      9. Definitions of terms used are included in these Standards.
  2. GENERAL REQUIREMENTS FOR PROTECTION AND SAFETY
    • DEFINITIONS
      1. Terms used have the meanings given under Definitions.
    • INTERPRETATION
      1. Except as specifically authorized by the statutory governing body of a Sponsoring Organization, no interpretation of these Standards by any officer or employee of the Sponsoring Organization other than a written interpretation by the Director General of the Sponsoring Organization will be binding on the Sponsoring Organization.
    • RESOLUTION OF CONFLICTS
      1. The requirements of these Standards are in addition to and not in place of other applicable requirements, such as those of relevant binding conventions and national laws and regulations.
      2. In cases of conflict between the requirements of these Standards and other applicable requirements, the government or the regulatory body, as appropriate, shall determine which requirements are to be enforced.
      3. Nothing in these Standards shall be construed as restricting any actions that may otherwise be necessary for protection and safety or as relieving the parties referred to in paras 2.40 and 2.41 from complying with applicable laws and regulations.
    • ENTRY INTO FORCE
      1. These Standards shall enter into force one year after the date of their adoption or acknowledgement, as appropriate, by the Sponsoring Organization.
      2. If a State decides to adopt these Standards, these Standards shall come into force at the time indicated in the formal adoption by that State.
    • APPLICATION OF THE PRINCIPLES OF RADIATION PROTECTION
      Requirement 1: Application of the principles of radiation protection
      Parties with responsibilities for protection and safety shall ensure that the principles of radiation protection are applied for all exposure situations.
      1. For planned exposure situations, each party with responsibilities for protection and safety shall ensure, when relevant requirements apply to that party, that no practice is undertaken unless it is justified.
      2. For emergency exposure situations and existing exposure situations, each party with responsibilities for protection and safety shall ensure, when relevant requirements apply to that party, that protective actions or remedial actions are justified and are undertaken in such a way as to achieve the objectives set out in a protection strategy.
      3. For all exposure situations, each party with responsibilities for protection and safety shall ensure, when relevant requirements apply to that party, that protection and safety is optimized9.
      4. For planned exposure situations other than for medical exposure, each party with responsibilities for protection and safety shall ensure that, when relevant requirements apply to that party, specified dose limits are not exceeded.
      5. The application of the requirements for the system of protection and safety shall be commensurate with the radiation risks associated with the exposure situation.
    • RESPONSIBILITIES OF THE GOVERNMENT10
      Requirement 2: Establishment of a legal and regulatory framework
      The government shall establish and maintain a legal and regulatory framework for protection and safety and shall establish an effectively independent regulatory body with specified responsibilities and functions.
      1. The government shall establish and maintain an appropriate and effective legal and regulatory framework for protection and safety in all exposure situations.11 This framework shall encompass both the assignment and the discharge of governmental responsibilities, and the regulatory control of facilities and activities that give rise to radiation risks. The framework shall allow for the fulfilment of international obligations.
      2. The government shall ensure that adequate arrangements are in place for the protection of people and the environment, both now and in the future, against harmful effects of ionizing radiation, without unduly limiting the operation of facilities or the conduct of activities that give rise to radiation risks. This shall include arrangements for the protection of people of present and future generations and populations remote from present facilities and activities.
      3. The government shall establish legislation that, among other things:
        1. Provides the statutory basis for requirements for protection and safety for all exposure situations;
        2. Specifies that the prime responsibility for protection and safety rests with the person or organization responsible for facilities and activities that give rise to radiation risks;
        3. Specifies the scope of its applicability;
        4. Establishes and provides for maintaining an independent regulatory body with clearly specified functions and responsibilities for the regulation of protection and safety;
        5. Provides for coordination between authorities with responsibilities relevant to protection and safety for all exposure situations.
      4. The government shall ensure that the regulatory body is effectively independent, in making decisions relating to protection and safety, of persons and organizations using or promoting the use of radiation and radioactive material, so that it is free from any undue influence by interested parties and from any conflicts of interest; and shall ensure that it has functional separation from entities having responsibilities or interests that could unduly influence its decision making.
      5. The government shall ensure that the regulatory body has the legal authority, competence and resources necessary to fulfil its statutory functions and responsibilities.
      6. The government shall ensure that a graded approach is taken to the regulatory control of radiation exposure, so that the application of regulatory requirements is commensurate with the radiation risks associated with the exposure situation.
      7. The government shall establish mechanisms to ensure that:
        1. The activities of the regulatory body are coordinated with those of other governmental authorities, in accordance with para. 2.15(e), and with national and international organizations that have related responsibilities;
        2. Interested parties are involved as appropriate in regulatory decision making processes or regulatory decision aiding processes.
      8. The government shall ensure that arrangements are in place at the national level for making decisions relating to protection and safety that fall outside the authority of the regulatory body.
        1. The government shall ensure that requirements are established for:
        2. Education, training, qualification and competence in protection and safety of all persons engaged in activities relevant to protection and safety;
        3. The formal recognition12 of qualified experts;
        4. The competence of organizations that have responsibilities relating to protection and safety.
      9. The government shall ensure that arrangements are in place for the provision of the education and training services required for building and maintaining the competence of persons and organizations that have responsibilities relating to protection and safety.
      10. The government shall ensure that arrangements are in place for the provision of technical services relating to protection and safety, such as services for personal dosimetry, environmental monitoring and the calibration of monitoring and measuring equipment.
      11. The government shall ensure that arrangements are in place for the safe decommissioning of facilities [9], the safe management of radioactive waste [10, 11] and the safe management of spent fuel.
      12. The government shall ensure that the transport of radioactive material is in accordance with the IAEA Regulations for the Safe Transport of Radioactive Material (the IAEA Transport Regulations) [12] and with any applicable international conventions, taking into consideration other internationally endorsed standards and recommendations derived from the IAEA Transport Regulations.13
      13. The government shall ensure that arrangements are in place for regaining control over radioactive sources that have been abandoned, lost, misplaced, stolen or otherwise transferred without proper authorization.
      14. The government shall ensure that infrastructural arrangements are in place for the interfaces between safety and the security of radioactive sources.
      15. In establishing the legal and regulatory framework for protection and safety, the government:
        1. Shall fulfil its respective international obligations;
        2. Shall allow for participation in relevant international arrangements, including international peer reviews;
        3. Shall promote international cooperation to enhance safety globally.
    • RESPONSIBILITIES OF THE REGULATORY BODY
      Requirement 3: Responsibilities of the regulatory body
      The regulatory body shall establish or adopt regulations and guides for protection and safety and shall establish a system to ensure their implementation.
      1. The regulatory body shall establish requirements for the application of the principles of radiation protection specified in paras 2.8–2.12 for all exposure situations and shall establish or adopt regulations and guides for protection and safety.
      2. The regulatory body shall establish a regulatory system for protection and safety that includes [8]:
        1. Notification and authorization;
        2. Review and assessment of facilities and activities;
        3. Inspection of facilities and activities;
        4. Enforcement of regulatory requirements;
        5. The regulatory functions relevant to emergency exposure situations and existing exposure situations;
        6. Provision of information to, and consultation with, parties affected by its decisions and, as appropriate, the public and other interested parties.
      3. The regulatory body shall adopt a graded approach to the implementation of the system of protection and safety, such that the application of regulatory requirements is commensurate with the radiation risks associated with the exposure situation.
      4. The regulatory body shall ensure the application of the requirements for education, training, qualification and competence in protection and safety of all persons engaged in activities relevant to protection and safety.
      5. The regulatory body shall ensure that mechanisms are in place for the timely dissemination of information to relevant parties, such as suppliers of and users of sources, on lessons learned for protection and safety from regulatory experience and operating experience, and from incidents and accidents and the related findings. The mechanisms established shall, as appropriate, be used to provide relevant information to other relevant organizations at the national and international level.
      6. The regulatory body, in conjunction with other relevant authorities, shall specify requirements for acceptance and for performance, by regulation or by the application of published standards, for any manufactured or constructed source, device, equipment or facility that, when in use, has implications for protection and safety.
      7. The regulatory body shall make provision for establishing, maintaining and retrieving adequate records relating to facilities and activities. These records shall include:
        • — Registers of sealed sources and radiation generators14;
        • — Records of doses from occupational exposure;
        • — Records relating to the safety of facilities and activities;
        • — Records that might be necessary for the shutdown and decommissioning or closure of facilities;
        • — Records of events, including non-routine releases of radioactive material to the environment;
        • — Inventories of radioactive waste and of spent fuel.
      8. The regulatory body shall establish mechanisms for communication and discussion that involve professional and constructive interactions with relevant parties for all protection and safety related issues.
      9. The regulatory body, in consultation with the health authority, shall ensure that provisions are in place for ensuring protection and safety in the handling of deceased persons or human remains that are known to contain sealed or unsealed radioactive sources, either as a result of radiological procedures for medical treatment of patients or as a consequence of an emergency.
      10. The regulatory body shall establish, implement, assess and strive to continually improve a management system that is aligned with the goals of the regulatory body and that contributes to the achievement of those goals.
    • RESPONSIBILITIES FOR PROTECTION AND SAFETY
      Requirement 4: Responsibilities for protection and safety
      The person or organization responsible for facilities and activities that give rise to radiation risks shall have the prime responsibility for protection and safety. Other parties shall have specified responsibilities for protection and safety.
      1. The person or organization responsible for any facility or activity that gives rise to radiation risks shall have the prime responsibility for protection and safety, which cannot be delegated.
      2. The principal parties responsible for protection and safety are:
        1. Registrants or licensees, or the person or organization responsible for facilities and activities for which notification only is required;
        2. Employers, in relation to occupational exposure;
        3. Radiological medical practitioners, in relation to medical exposure;
        4. Those persons or organizations designated to deal with emergency exposure situations or existing exposure situations.
      3. Other parties shall have specified responsibilities in relation to protection and safety. These other parties include:
        1. Suppliers of sources, providers of equipment and software, and providers of consumer products;
        2. Radiation protection officers;
        3. Referring medical practitioners;
        4. Medical physicists;
        5. Medical radiation technologists;
        6. Qualified experts or any other party to whom a principal party has assigned specific responsibilities;
        7. Workers other than workers listed in (a)–(f) in this paragraph;
        8. Ethics committees.
      4. The relevant principal parties shall establish and implement a protection and safety programme that is appropriate for the exposure situation. The protection and safety programme:
        1. Shall adopt objectives for protection and safety in accordance with the requirements of these Standards;
        2. Shall apply measures for protection and safety that are commensurate with the radiation risks associated with the exposure situation and that are adequate to ensure compliance with the requirements of these Standards.
      5. The relevant principal parties shall ensure that, in the implementation of the protection and safety programme:
        1. The measures and resources that are necessary for achieving the objectives for protection and safety have been determined and are duly provided;
        2. The programme is periodically reviewed to assess its effectiveness and its continued fitness for purpose;
        3. Any failures or shortcomings in protection and safety are identified and corrected, and steps are taken to prevent their recurrence;
        4. Arrangements are made to consult with interested parties;
        5. Appropriate records are maintained.
      6. The relevant principal parties and other parties having specified responsibilities in relation to protection and safety shall ensure that all personnel engaged in activities relevant to protection and safety have appropriate education, training and qualification so that they understand their responsibilities and can perform their duties competently, with appropriate judgement and in accordance with procedures.
      7. The relevant principal parties shall permit access by authorized representatives of the regulatory body to carry out inspections of their facilities and activities and of their protection and safety records, and shall cooperate in the conduct of inspections.
      8. The relevant principal parties shall ensure that qualified experts are identified and are consulted as necessary on the proper observance of these Standards.
    • MANAGEMENT REQUIREMENTS
      Requirement 5: Management for protection and safety
      The principal parties shall ensure that protection and safety are effectively integrated into the overall management system of the organizations for which they are responsible.
      • Protection and safety elements of the management system
        1. The principal parties shall demonstrate commitment to protection and safety at the highest levels within the organizations for which they are responsible.
        2. The principal parties shall ensure that the management system15 is designed and applied to enhance protection and safety by:
          1. Applying the requirements for protection and safety coherently with other requirements, including requirements for operational performance, and coherently with guidelines for security;
          2. Describing the planned and systematic actions necessary to provide adequate confidence that the requirements for protection and safety are fulfilled;
          3. Ensuring that protection and safety are not compromised by other requirements;
          4. Providing for the regular assessment of performance for protection and safety, and the application of lessons learned from experience;
          5. Promoting safety culture.
        3. The principal parties shall ensure that protection and safety elements of the management system are commensurate with the complexity of and the radiation risks associated with the activity.
        4. The principal parties shall be able to demonstrate the effective fulfilment of the requirements for protection and safety in the management system.
      • Safety culture
        1. The principal parties shall promote and maintain safety culture by:
          1. Promoting individual and collective commitment to protection and safety at all levels of the organization;
          2. Ensuring a common understanding of the key aspects of safety culture within the organization;
          3. Providing the means by which the organization supports individuals and teams in carrying out their tasks safely and successfully, with account taken of the interactions between individuals, technology and the organization;
          4. Encouraging the participation of workers and their representatives and other relevant persons in the development and implementation of policies, rules and procedures dealing with protection and safety;
          5. Ensuring accountability of the organization and of individuals at all levels for protection and safety;
          6. Encouraging open communication with regard to protection and safety within the organization and with relevant parties, as appropriate;
          7. Encouraging a questioning and learning attitude, and discouraging complacency, with regard to protection and safety;
          8. Providing means by which the organization continually seeks to develop and strengthen its safety culture.
      • Human factors
        1. The principal parties and other parties having specified responsibilities in relation to protection and safety, as appropriate, shall take into account human factors and shall support good performance and good practices to prevent human and organizational failures, by ensuring among other things that:
          1. Sound ergonomic principles are followed in the design of equipment and the development of operating procedures, so as to facilitate the safe operation and use of equipment, to minimize the possibility that operator errors could lead to accidents, and to reduce the possibility that indications of normal conditions and abnormal conditions could be misinterpreted.
          2. Appropriate equipment, safety systems and procedural requirements are provided, and other necessary provision is made:
            1. To reduce, as far as practicable, the possibility that human errors or inadvertent actions could give rise to accidents or to other incidents leading to the exposure of any person;
            2. To provide means for detecting human errors and for correcting them or compensating for them;
            3. To facilitate protective actions and corrective actions in the event of failures of safety systems or failures of measures for protection and safety.
  3. PLANNED EXPOSURE SITUATIONS
    • SCOPE
      1. The requirements for planned exposure situations apply to the following practices:
        1. The production, supply, provision and transport of radioactive material and of devices that contain radioactive material, including sealed sources and unsealed sources, and of consumer products;
        2. The production and supply of devices that generate radiation, including linear accelerators, cyclotrons, and fixed and mobile radiography equipment;
        3. The generation of nuclear power, including any activities within the nuclear fuel cycle that involve or that could involve exposure to radiation or exposure due to radioactive material;
        4. The use of radiation or radioactive material for medical, industrial, veterinary, agricultural, legal or security purposes, including the use of associated equipment, software or devices where such use could affect exposure to radiation;
        5. The use of radiation or radioactive material for education, training or research, including any activities relating to such use that involve or could involve exposure to radiation or exposure due to radioactive material;
        6. The mining and processing of raw materials that involve exposure due to radioactive material;
        7. Any other practice as specified by the regulatory body.
      2. The requirements for planned exposure situations apply to exposure due to sources within practices16, as follows:
        1. Facilities that contain radioactive material and facilities that contain radiation generators, including nuclear installations, medical radiation facilities, veterinary radiation facilities, facilities for the management of radioactive waste, installations for the processing of radioactive material, irradiation facilities, and mineral extraction and mineral processing facilities that involve or could involve exposure to radiation or exposure due to radioactive material;
        2. Individual sources of radiation, including sources within the types of facility mentioned in para. 3.2(a), as appropriate, in accordance with the requirements of the regulatory body.
      3. The requirements for planned exposure situations apply for any occupational exposure, medical exposure or public exposure due to any practice or due to a source within a practice as specified in paras 3.1 and 3.2.
      4. Exposure due to natural sources is, in general, considered an existing exposure situation and is subject to the requirements in Section 5. However, the relevant requirements in Section 3 for planned exposure situations apply to:
        1. Exposure due to material{Footnote_17} in any practice specified in para. 3.1 where the activity concentration in the material of any radionuclide in the uranium decay chain or the thorium decay chain is greater than 1 Bq/g or the activity concentration of 40K is greater than 10 Bq/g;
        2. Public exposure due to discharges or due to the management of radioactive waste arising from a practice involving material as specified in (a) above;
        3. Exposure due to 222Rn and to 222Rn progeny and due to 220Rn and to 220Rn progeny in workplaces in which occupational exposure due to other radionuclides in the uranium decay chain or the thorium decay chain is controlled as a planned exposure situation;
        4. Exposure due to 222Rn and to 222Rn progeny where the annual average activity concentration of 222Rn in air in workplaces remains above the reference level established in accordance with para. 5.27 after the fulfilment of the requirement in para. 5.28.
    • GENERIC REQUIREMENTS
      No person or organization shall adopt, introduce, conduct, discontinue or cease a practice, or shall, as applicable, mine, extract, process, design, manufacture, construct, assemble, install, acquire, import, export, supply, provide, distribute, loan, hire, receive, site, locate, commission, possess, use, operate, maintain, repair, transfer, decommission, disassemble, transport, store or dispose of a source within a practice other than in accordance with the requirements of these Standards.
      Requirement 6: Graded approach
      The application of the requirements of these Standards in planned exposure situations shall be commensurate with the characteristics of the practice or the source within a practice, and with the likelihood and magnitude of exposures.
      1. The application of the requirements of these Standards shall be in accordance with the graded approach and shall also conform to any requirements specified by the regulatory body. Not all the requirements of these Standards are relevant for every practice or source, or for all the actions specified in para. 3.5.
      Requirement 7: Notification and authorization
      Any person or organization intending to operate a facility or to conduct an activity shall submit to the regulatory body a notification and, as appropriate, an application for authorization.
      Notification
      1. Any person or organization intending to carry out any of the actions specified in para. 3.5 shall submit a notification to the regulatory body of such an intention18. Notification alone is sufficient provided that the exposures expected to be associated with the practice or action are unlikely to exceed a small fraction, as specified by the regulatory body, of the relevant limits, and that the likelihood and magnitude of potential exposures and any other potential detrimental consequences are negligible. Notification is required for consumer products only with respect to manufacture, maintenance, import, export, provision, distribution and, in some cases, disposal.
      Authorization: Registration or licensing
      1. Any person or organization intending to carry out any of the actions specified in para. 3.5 shall, unless notification alone is sufficient, apply to the regulatory body for authorization18, which shall take the form of either registration19 or licensing.
      2. Any person or organization applying for authorization:
        1. Shall submit to the regulatory body the relevant information necessary to support the application;
        2. Shall refrain from carrying out any of the actions specified in para. 3.5 until the registration or the licence has been issued;
        3. Shall assess the nature, likelihood and magnitude of the expected exposures due to the source and shall take all necessary measures for protection and safety;
        4. Shall, if there is a possibility for an exposure to be greater than a level as specified by the regulatory body, have a safety assessment made and submitted to the regulatory body as part of the application;
        5. Shall, as required by the regulatory body, have an appropriate prospective assessment made for radiological environmental impacts, commensurate with the radiation risks associated with the facility or activity.
      Requirement 8: Exemption and clearance
      The government or the regulatory body shall determine which practices or sources within practices are to be exempted from some or all of the requirements of these Standards. The regulatory body shall approve which sources, including materials and objects, within notified practices or authorized practices may be cleared from regulatory control.
      Exemption
      1. The government or the regulatory body shall determine which practices or sources within practices are to be exempted from some or all of the requirements of these Standards, including the requirements for notification, registration or licensing, using as the basis for this determination the criteria for exemption specified in Schedule I or any exemption levels specified by the regulatory body on the basis of these criteria.
      2. Exemption shall not be granted for practices deemed to be not justified.
      Clearance
      1. The regulatory body shall approve which sources, including materials and objects, within notified or authorized practices may be cleared from regulatory control, using as the basis for such approval the criteria for clearance specified in Schedule I or any clearance levels specified by the regulatory body on the basis of these criteria. By means of this approval, the regulatory body shall ensure that sources that have been cleared from regulatory control do not again become subject to the requirements for notification, registration or licensing unless it so specifies.
      Requirement 9: Responsibilities of registrants and licensees in planned exposure situations
      Registrants and licensees shall be responsible for protection and safety in planned exposure situations.
      1. Registrants and licensees shall bear the responsibility for setting up and implementing the technical and organizational measures that are necessary for protection and safety for the practices and sources for which they are authorized. Registrants and licensees may designate suitably qualified persons to carry out tasks relating to these responsibilities, but they shall retain the prime responsibility for protection and safety. Registrants and licensees shall document the names and responsibilities of persons designated to ensure compliance with the requirements of these Standards.
      2. Registrants and licensees shall notify the regulatory body of any intention to introduce modifications to any practice or source for which they are authorized, whenever the modifications could have significant implications for protection and safety, and they shall not carry out any such modification unless it is specifically authorized by the regulatory body.
      3. Registrants and licensees:
        1. Shall establish clear lines of responsibility and accountability for protection and safety for the sources for which they are authorized, and shall establish organizational arrangements for protection and safety;
        2. Shall ensure that any delegation of responsibilities by a principal party is documented;
        3. Shall, for the sources for which they are authorized and for which a safety assessment is required in para. 3.9(d), conduct such a safety assessment and keep it up to date in accordance with para. 3.35;
        4. Shall, for the sources for which they are authorized and for which the regulatory body requires a prospective assessment to be made for radiological environmental impacts (see para. 3.9(e)), conduct such an assessment and keep it up to date;
        5. Shall assess the likelihood and magnitude of potential exposures, their likely consequences and the number of individuals who may be affected by them;
        6. Shall have in place operating procedures and arrangements for protection and safety that are subject to periodic review and updating under a management system;
        7. Shall establish procedures for reporting on and learning from accidents and other incidents;
        8. Shall establish arrangements for the periodic review of the overall effectiveness of the measures for protection and safety;
        9. Shall ensure that adequate maintenance, testing and servicing are carried out as necessary so that sources remain capable of fulfilling their design requirements for protection and safety throughout their lifetime;
        10. Shall ensure safe management of and control over all radioactive waste that is generated, and shall dispose of such waste in accordance with the regulatory requirements.
      Requirement 10: Justification of practices
      The government or the regulatory body shall ensure that only justified practices are authorized.
      1. The government or the regulatory body, as appropriate, shall ensure that provision20 is made for the justification of any type of practice21 and for review of the justification, as necessary, and shall ensure that only justified practices are authorized.
      2. The following practices are deemed to be not justified:
        1. Practices, except for justified practices involving medical exposure22, that result in an increase in activity, by the deliberate addition of radioactive substances or by activation23, in food, feed, beverages, cosmetics or any other commodity or product intended for ingestion, inhalation or percutaneous intake by, or application to, a person;
        2. Practices involving the frivolous use of radiation or radioactive substances in commodities or in consumer products such as toys and personal jewellery or adornments, which result in an increase in activity, by the deliberate addition of radioactive substances or by activation23;
        3. Human imaging using radiation that is performed as a form of art or for publicity purposes.
      3. Human imaging using radiation that is performed for occupational, legal or health insurance purposes24, and is undertaken without reference to clinical indication, shall normally be deemed to be not justified. If, in exceptional circumstances, the government or the regulatory body decides that the justification of such human imaging for specific practices is to be considered, the requirements of paras 3.61–3.64 and 3.66 shall apply.
      4. Human imaging using radiation for theft detection purposes shall be deemed to be not justified.
      5. Human imaging using radiation for the detection of concealed objects for anti-smuggling purposes shall normally be deemed to be not justified. If, in exceptional circumstances, the government or the regulatory body decides that the justification of such human imaging is to be considered, the requirements of paras 3.61–3.67 shall apply.
      6. Human imaging using radiation for the detection of concealed objects that can be used for criminal acts that pose a national security threat shall be justified only by the government. If the government decides that the justification of such human imaging is to be considered, the requirements of paras 3.61–3.67 shall apply.
      Requirement 11: Optimization of protection and safety
      The government or the regulatory body shall establish and enforce requirements for the optimization of protection and safety, and registrants and licensees shall ensure that protection and safety is optimized.
      1. The government or the regulatory body:
        1. Shall establish and enforce requirements for the optimization of protection and safety;
        2. Shall require documentation addressing the optimization of protection and safety;
        3. Shall establish or approve constraints25 on dose and on risk, as appropriate, or shall establish or approve a process for establishing such constraints, to be used in the optimization of protection and safety.
      2. Registrants and licensees shall ensure that protection and safety is optimized.
      3. For occupational exposure and public exposure26, registrants and licensees shall ensure that all relevant factors are taken into account in a coherent way in the optimization of protection and safety to contribute to achieving the following objectives:
        1. To determine measures for protection and safety that are optimized for the prevailing circumstances, with account taken of the available options for protection and safety as well as the nature, likelihood and magnitude of exposures;
        2. To establish criteria, on the basis of the results of the optimization, for the restriction of the likelihood and magnitudes of exposures by means of measures for preventing accidents and for mitigating the consequences of those that do occur.
      4. For occupational exposure and public exposure, registrants and licensees shall ensure, as appropriate, that relevant constraints are used in the optimization of protection and safety for any particular source within a practice.25
      Requirement 12: Dose limits
      The government or the regulatory body shall establish dose limits for occupational exposure and public exposure, and registrants and licensees shall apply these limits.
      1. The government or the regulatory body shall establish and the regulatory body shall enforce compliance with the dose limits specified in Schedule III for occupational exposures and public exposures in planned exposure situations.
      2. The government or the regulatory body shall determine what additional restrictions, if any, are required to be complied with by registrants and licensees to ensure that the dose limits specified in Schedule III are not exceeded owing to possible combinations of doses from exposures due to different authorized practices.
      3. Registrants and licensees shall ensure that the exposures of individuals due to the practices for which the registrants and licensees are authorized are restricted, so that neither the effective dose nor the equivalent dose to tissues or organs exceeds any relevant dose limit specified in Schedule III.27
      Requirement 13: Safety assessment
      The regulatory body shall establish and enforce requirements for safety assessment, and the person or organization responsible for a facility or activity that gives rise to radiation risks shall conduct an appropriate safety assessment of this facility or activity.
      1. The regulatory body shall establish requirements for persons or organizations responsible for facilities and activities that give rise to radiation risks to conduct an appropriate safety assessment28. Prior to the granting of an authorization, the responsible person or organization shall be required to submit a safety assessment, which shall be reviewed and assessed by the regulatory body.
      2. The person or organization, as required under para. 3.9(d), or registrants and licensees, as appropriate, shall conduct a safety assessment that is either generic or specific to the practice or source for which they are responsible.29
      3. Safety assessments shall be conducted at different stages, including the stages of siting, design, manufacture, construction, assembly, commissioning, operation, maintenance and decommissioning (or closure) of facilities or parts thereof, as appropriate, so as:
        1. To identify the ways in which exposures could be incurred, account being taken of the effects of external events as well as of events directly involving the sources and associated equipment;
        2. To determine the expected likelihood and magnitudes of exposures in normal operation and, to the extent reasonable and practicable, to make an assessment of potential exposures;
        3. To assess the adequacy of the provisions for protection and safety.
      4. The safety assessment shall include, as appropriate, a systematic critical review of:
        1. The operational limits and conditions for the operation of the facility;
        2. The ways in which structures, systems and components, including software, and procedures relating to protection and safety might fail, singly or in combination, or might otherwise give rise to exposures, and the consequences of such events;
        3. The ways in which external factors could affect protection and safety;
        4. The ways in which operating procedures relating to protection and safety might be erroneous, and the consequences of such errors;
        5. The implications for protection and safety of any modifications;
        6. The implications for protection and safety of security measures or of any modifications to security measures;
        7. Any uncertainties or assumptions and their implications for protection and safety.
      5. The registrant or licensee shall take into account in the safety assessment:
        1. Factors that could give rise to a substantial release of radioactive material, the measures available to prevent or to control such a release, and the maximum activity of radioactive material that, in the event of a major failure of the containment, could be released to the environment;
        2. Factors that could give rise to a smaller but continuing release of radioactive material, and the measures available to detect and to prevent or to control such a release;
        3. Factors that could give rise to unintended operation of any radiation generator or a loss of shielding, and the measures available to detect and to prevent or to control such occurrences;
        4. The extent to which the use of redundant and diverse safety features that are independent of each other, so that failure of one does not result in failure of any other, is appropriate to restrict the likelihood and magnitude of potential exposures.
      6. Registrants and licensees shall ensure that the safety assessment is documented and, where appropriate, that it is independently reviewed under the relevant management system.
      7. Registrants and licensees shall perform additional reviews of the safety assessment as necessary to ensure that the technical specifications or conditions of use continue to be met when:
        1. Significant modifications to the facility or to its operating procedures or maintenance procedures are envisaged;
        2. Significant changes occur on the site that could affect the safety of the facility or of activities on the site;
        3. Information on operating experience, or information about accidents and other incidents that could result in exposures, indicates that the current assessment might be invalid;
        4. Any significant changes in activities are envisaged;
        5. Any relevant changes in guidelines or standards have been made or are envisaged.
      8. If as a result of a safety assessment, or for any other reason, opportunities to improve protection and safety appear to be available and improvement seems desirable, any consequential modifications shall be made cautiously and only after favourable assessment of all the implications for protection and safety. The implementation of all improvements shall be prioritized so as to optimize protection and safety.
      Requirement 14: Monitoring for verification of compliance
      Registrants and licensees and employers shall conduct monitoring to verify compliance with the requirements for protection and safety.
      1. The regulatory body shall establish requirements that monitoring and measurements be performed to verify compliance with the requirements for protection and safety. The regulatory body shall be responsible for review and approval of the monitoring and measurement programmes of registrants and licensees.
      2. Registrants and licensees and employers shall ensure that:
        1. Monitoring and measurements of parameters are performed as necessary for verification of compliance with the requirements of these Standards;
        2. Suitable equipment is provided and procedures for verification are implemented;
        3. Equipment is properly maintained, tested and calibrated at appropriate intervals with reference to standards traceable to national or international standards;
        4. Records are maintained of the results of monitoring and verification of compliance, as required by the regulatory body, including records of the tests and calibrations carried out in accordance with these Standards;
        5. The results of monitoring and verification of compliance are shared with the regulatory body as required.
      Requirement 15: Prevention and mitigation of accidents
      Registrants and licensees shall apply good engineering practice and shall take all practicable measures to prevent accidents and to mitigate the consequences of those accidents that do occur.
      Good engineering practice
      1. The registrant or licensee, in cooperation with other responsible parties, shall ensure that the siting, location, design, manufacture, construction, assembly, commissioning, operation, maintenance and decommissioning (or closure) of facilities or parts thereof are based on good engineering practice which shall, as appropriate:
        1. Take account of international and national standards;
        2. Be supported by managerial and organizational features, with the purpose of ensuring protection and safety throughout the lifetime of the facility;
        3. Include adequate safety margins in the design and construction of the facility, and in operations involving the facility, so as to ensure reliable performance in normal operation, and take account of the necessary quality, redundancy and capability for inspection, with emphasis on preventing accidents, mitigating the consequences of those accidents that do occur and restricting any possible future exposures;
        4. Take account of relevant developments concerning technical criteria, as well as the results of any relevant research on protection and safety and feedback of information on lessons learned from experience.
      Defence in depth
      1. Registrants and licensees shall ensure that a multilevel (defence in depth) system of sequential, independent provisions for protection and safety that is commensurate with the likelihood and magnitude of potential exposures is applied to sources for which the registrants and licensees are authorized. Registrants and licensees shall ensure that if one level of protection were to fail, the subsequent independent level of protection would be available. Such defence in depth shall be applied for the purposes of:
        1. Preventing accidents;
        2. Mitigating the consequences of any accidents that do occur;
        3. Restoring the sources to safe conditions after any such accidents. Accident prevention
      2. Registrants and licensees shall ensure that structures, systems and components, including software, that are related to protection and safety for facilities and activities are designed, constructed, commissioned, operated and maintained so as to prevent accidents as far as reasonably practicable.
      3. The registrant or licensee for any facility or activity shall make suitable arrangements:
        1. To prevent reasonably foreseeable accidents in the facility or the activity;
        2. To mitigate the consequences of those accidents that do occur;
        3. To provide workers with the information, instruction, training and equipment necessary to restrict potential exposures;
        4. To ensure that there are adequate procedures for the control of the facility and for the management of any reasonably foreseeable accidents;
        5. To ensure that safety significant structures, systems and components, including software, and other equipment can be inspected and tested regularly for any degradation that could lead to abnormal conditions or inadequate performance;
        6. To ensure that maintenance, inspection and testing appropriate to the preservation of the provisions for protection and safety can be carried out without undue occupational exposure;
        7. To provide, wherever appropriate, automatic systems for safely shutting off or reducing the release of radiation from facilities in the event that operating conditions are outside the stipulated ranges;
        8. To ensure that abnormal operating conditions that could significantly affect protection and safety are detected by systems that respond quickly enough to allow for corrective action to be taken in a timely manner;
        9. To ensure that all relevant safety documentation is available in the appropriate languages understandable to users.
      Defence in depth
      1. If the safety assessment indicates that there is a reasonable likelihood of an emergency affecting either workers or members of the public, the registrant or licensee shall prepare an emergency plan for the protection of people and the environment. As part of this emergency plan, the registrant or licensee shall include arrangements for the prompt identification of an emergency, and for determining the appropriate level of the emergency response [15]. In relation to the arrangements for the emergency response at the scene by the registrant or licensee, the emergency plan shall include, in particular:
        1. Provision for individual monitoring and area monitoring, and arrangements for medical treatment;
        2. Arrangements for assessing and mitigating any consequences of an emergency.
      2. Registrants and licensees shall be responsible for the implementation of their emergency plans and shall be prepared to take any necessary action for effective response. To prevent the occurrence of conditions that could lead to a loss of control over a source or to the escalation of such conditions, registrants and licensees shall, as appropriate:
        1. Develop, maintain and implement procedures to provide the means for preventing loss of control over the source and for regaining control over the source as necessary;
        2. Make available equipment, instrumentation and diagnostic aids that may be needed;
        3. Train and periodically retrain personnel in the procedures to be followed and exercise the procedures.
      Requirement 16: Investigations and feedback of information on operating experience
      Registrants and licensees shall conduct formal investigations of abnormal conditions arising in the operation of facilities or the conduct of activities, and shall disseminate information that is significant for protection and safety.
      1. Registrants and licensees shall ensure that information on both normal operation and abnormal conditions that are significant for protection and safety is disseminated or made available, as appropriate, to the regulatory body and relevant parties, as specified by the regulatory body. This information would include, for example, details of doses associated with given activities, data on maintenance, descriptions of events and information on corrective actions, and information on operating experience from other relevant facilities and activities.
      2. Registrants and licensees shall conduct an investigation as specified by the regulatory body in the event that:
        1. A quantity or operating parameter relating to protection and safety exceeds an investigation level or is outside the stipulated range of operating conditions; or
        2. Any equipment failure, accident, error, mishap or other unusual event or condition occurs that has the potential for causing a quantity to exceed any relevant limit or operating restriction.
      3. The registrant or licensee shall conduct an investigation as soon as possible after an event and shall prepare a written record of its causes, or suspected causes, including a verification or determination of any doses received or committed and recommendations for preventing the recurrence of the event and the occurrence of similar events.
      4. The registrant or licensee shall communicate to the regulatory body and to any other relevant parties, as appropriate, a written report of any formal investigation relating to events as prescribed by the regulatory body, including exposures giving rise to doses exceeding a dose limit. The registrant or licensee shall also immediately report to the regulatory body any event in which a dose limit is exceeded.
      Requirement 17: Radiation generators and radioactive sources
      Registrants and licensees shall ensure the safety of radiation generators and radioactive sources.
      1. Registrants and licensees who are manufacturers or other suppliers of radiation generators and radioactive sources shall ensure that the following responsibilities are discharged, as applicable:
        1. Supplying a well designed, well manufactured and well constructed radiation generator or radioactive source and device in which the radiation generator or radioactive source is used that:
          1. Provides for protection and safety in accordance with the requirements of these Standards;
          2. Meets engineering, performance and functional specifications;
          3. Meets quality standards commensurate with the significance for protection and safety of systems and components, including software;
          4. Provides clear displays, gauges and instructions on operating consoles in the appropriate language understandable to users.
        2. Ensuring that radiation generators and radioactive sources are tested to demonstrate compliance with the relevant specifications.
        3. Making information available, in the appropriate language understandable to users, on the proper installation and use of the radiation generator or radioactive source and on its associated radiation risks, including performance specifications, instructions for operating and maintenance, and instructions for protection and safety.
        4. Ensuring that the protection provided by shielding and by other protective devices is optimized.
      2. Where applicable, registrants and licensees shall make suitable arrangements with suppliers of radiation generators and radioactive sources, the regulatory body and relevant parties for the purposes of:
        1. Obtaining information on conditions of use and operating experience that may be important for protection and safety;
        2. Providing feedback and information that may have implications for protection and safety for other users, or that may have implications for the possibility for improvements in protection and safety for radiation generators and radioactive sources.
      3. When choosing a location to use or to store a radiation generator or radioactive source, registrants and licensees shall take into account:
        1. Factors that could affect the safe management of and control over the radiation generator or radioactive source;
        2. Factors that could affect occupational exposure and public exposure due to the radiation generator or radioactive source;
        3. The feasibility of taking the foregoing factors into account in engineering design.
      4. In selecting a site for a facility that will contain a large amount of radioactive material and that will have the potential for the release of significant amounts of radioactive material, registrants and licensees shall take into account features that might affect protection and safety, features that might affect the integrity or functioning of the facility, and the feasibility of carrying out off-site protective actions if they become necessary.
      5. Registrants and licensees shall maintain an inventory that includes records of:
        1. The location and description of each radiation generator or radioactive source for which they are responsible;
        2. The activity and form of each radioactive source for which they are responsible.
      6. Registrants and licensees shall provide the regulatory body as required with appropriate information from their inventory records of radiation generators and radioactive sources.
      7. Registrants and licensees shall keep radiation generators and radioactive sources under control so as to prevent loss or damage and to prevent any unauthorized person from carrying out any of the activities specified in para. 3.5, by ensuring that:
        1. Control over a radiation generator or radioactive source is relinquished only in compliance with all relevant requirements specified in the registration or licence;
        2. The regulatory body is promptly notified of information regarding a radiation generator or radioactive source that is lost, missing or not under control;
        3. A radiation generator or radioactive source is transferred only if the recipient possesses the necessary authorization;
        4. An inventory, as required in para. 3.53, of radiation generators or radioactive sources is checked periodically to confirm that they are in their assigned locations and are under control.
      8. Registrants and licensees shall ensure that sealed sources are categorized in accordance with the categorization scheme set out in Schedule II, and in accordance with the requirements of the regulatory body.
      9. The manufacturer of a radioactive source or a device containing a radioactive source shall ensure that, where practicable, the source itself and its container are marked with the symbol recommended by the International Organization for Standardization [16]30.
      10. Registrants and licensees, in cooperation with manufacturers, shall ensure that, where practicable, sealed sources are identifiable and traceable.
      11. Registrants and licensees shall ensure that when radioactive sources are not in use they are stored in an appropriate manner for protection and safety.
      12. Registrants and licensees shall ensure that arrangements are made promptly for the safe management of and control over radiation generators and radioactive sources, including appropriate financial provision, once it has been decided to take them out of use.
      Requirement 18: Human imaging using radiation for purposes other than medical diagnosis, medical treatment or biomedical research
      The government shall ensure that the use of ionizing radiation for human imaging for purposes other than medical diagnosis, medical treatment or biomedical research is subject to the system of protection and safety.
      1. The government, if so decided in accordance with paras 3.18, 3.20 and 3.21, shall ensure that the requirements of para. 3.16 for the justification of practices are applied to any type of human imaging procedure in which radiation is used for purposes other than for medical diagnosis or medical treatment or other than as part of a programme of biomedical research. The justification process shall include the consideration of:
        1. The benefits and detriments of implementing the type of human imaging procedure;
        2. The benefits and detriments of not implementing the type of human imaging procedure;
        3. Any legal or ethical issues associated with the introduction of the type of human imaging procedure;
        4. The effectiveness and suitability of the type of human imaging procedure, including the appropriateness of the radiation equipment for the intended use;
        5. The availability of sufficient resources to conduct the human imaging procedure safely throughout the intended period of the practice.
      2. If it has been determined by means of the process specified in para. 3.61 that a particular practice of human imaging using radiation is justified, then such a practice shall be subject to regulatory control.
      3. The regulatory body, in cooperation with other relevant authorities, agencies and professional bodies, as appropriate, shall establish the requirements for regulatory control of the practice and for review of the justification.
      4. For human imaging using radiation, performed by medical personnel using medical radiological equipment, that exposes people to radiation for employment related, legal or health insurance31 purposes without reference to clinical indications:
        1. The government shall ensure, on the basis of consultation between relevant authorities, professional bodies and the regulatory body, that dose constraints are established for such human imaging;
        2. The registrant or licensee shall ensure that the appropriate optimization requirements for medical exposure in paras 3.162–3.177 are applied, with dose constraints as required in (a) above used instead of diagnostic reference levels.
      5. Procedures with inspection imaging devices in which radiation is used to expose persons for the purpose of detection of concealed weapons, contraband or other objects on or within the body shall be considered to give rise to public exposure. Registrants and licensees shall apply the requirements for public exposure in planned exposure situations. In particular, registrants and licensees shall ensure that optimization of protection and safety is subject to any dose constraints for public exposure set by the government or the regulatory body.
      6. Registrants and licensees shall ensure that all persons who are to undergo procedures with inspection imaging devices in which ionizing radiation is used are informed of the possibility of requesting the use of an alternative inspection technique that does not use ionizing radiation, where available.
      7. The registrant or licensee shall ensure that any inspection imaging device used for the detection of concealed objects on or within the body, whether it is manufactured in or imported into the State in which it is used, conforms to applicable standards of the International Electrotechnical Commission or the International Organization for Standardization or to equivalent national standards.
    • OCCUPATIONAL EXPOSURE
      Scope
      1. The requirements in respect of occupational exposure in planned exposure situations (paras 3.69–3.116) apply to occupational exposure due to a practice or a source within a practice, as stated in paras 3.1–3.3; and to occupational exposure as required in Section 4 for emergency exposure situations and as required in Section 5 for existing exposure situations. For exposure due to natural sources, these requirements for occupational exposure in planned exposure situations apply, as appropriate, only to the exposure situations specified in para. 3.4(a), (c) and (d).
      Requirement 19: Responsibilities of the regulatory body specific to occupational exposure
      The government or the regulatory body shall establish and enforce requirements to ensure that protection and safety is optimized, and the regulatory body shall enforce compliance with dose limits for occupational exposure.
      1. The government or the regulatory body shall establish the responsibilities of employers, registrants and licensees with regard to application of the requirements for occupational exposure in planned exposure situations.
      2. The government or the regulatory body shall establish and enforce requirements to ensure that protection and safety is optimized for occupational exposure.
      3. The government or the regulatory body shall establish, and the regulatory body shall enforce compliance with, the dose limits specified in Schedule III for occupational exposure.
      4. Before authorization of a new or modified practice, the regulatory body shall require, as appropriate, and review supporting documents from the responsible parties that state:
        1. Design criteria and design features relating to the exposure and potential exposure of workers in all operational states and in accident conditions;
        2. Design criteria and design features of the appropriate systems and programmes for monitoring of workers for occupational exposure in all operational states and in accident conditions.
      Requirement 20: Requirements for monitoring and recording of occupational exposures
      The regulatory body shall establish and enforce requirements for the monitoring and recording of occupational exposures in planned exposure situations.
      1. The regulatory body shall be responsible, as appropriate, for:
        1. Establishment and enforcement of requirements for the monitoring, recording and control of occupational exposures in planned exposure situations in accordance with the requirements of these Standards;
        2. Review of monitoring programmes of registrants and licensees, which shall be adequate to ensure that the requirements with regard to occupational exposure in planned exposure situations are fulfilled;
        3. Authorization or approval of service providers for individual monitoring and calibration services;
        4. Review of periodic reports on occupational exposure (including results of monitoring programmes and dose assessments) submitted by employers, registrants and licensees;
        5. Provision for maintaining exposure records and results of the assessment of doses from occupational exposure;
        6. Verification of compliance of an authorized practice with the requirements on the control of occupational exposure.
      Requirement 21: Responsibilities of employers, registrants and licensees for the protection of workers
      Employers, registrants and licensees shall be responsible for the protection of workers against occupational exposure. Employers, registrants and licensees shall ensure that protection and safety is optimized and that the dose limits for occupational exposure are not exceeded.
      1. For workers who are engaged in activities in which they are or could be subject to occupational exposure in planned exposure situations, employers, registrants and licensees shall be responsible for:
        1. Protection of workers against occupational exposure;
        2. Compliance with other relevant requirements of these Standards.
      2. Employers who are also registrants or licensees shall have the responsibilities of both employers and registrants or licensees.
      3. Employers, registrants and licensees shall ensure, for all workers engaged in activities in which they are or could be subject to occupational exposure, that:
        1. Occupational exposure is controlled so that the relevant dose limits for occupational exposure specified in Schedule III are not exceeded;
        2. Protection and safety is optimized in accordance with the requirements of these Standards;
        3. Decisions with regard to measures for protection and safety are recorded and made available to relevant parties, through their representatives where appropriate, as specified by the regulatory body;
        4. Policies, procedures and organizational arrangements for protection and safety are established for implementing the relevant requirements of these Standards, with priority given to design measures and technical measures for controlling occupational exposure;
        5. Suitable and adequate facilities, equipment and services for protection and safety are provided, the type and extent of which are commensurate with the expected likelihood and magnitude of occupational exposure;
        6. Necessary workers’ health surveillance and health services for workers are provided;
        7. Appropriate monitoring equipment and personal protective equipment is provided and arrangements are made for its proper use, calibration, testing and maintenance;
        8. Suitable and adequate human resources and appropriate training in protection and safety are provided, as well as periodic retraining as required to ensure the necessary level of competence;
        9. Adequate records are maintained in accordance with the requirements of these Standards;
        10. Arrangements are made to facilitate consultation of and cooperation with workers, through their representatives where appropriate, with regard to protection and safety on all measures necessary to achieve the effective application of these Standards;
        11. Necessary conditions for promoting safety culture are provided.
      4. Employers, registrants and licensees:
        1. Shall involve workers, through their representatives where appropriate, in optimization of protection and safety;
        2. Shall establish and use, as appropriate, constraints as part of optimization of protection and safety.
      5. Employers, registrants and licensees shall ensure that workers exposed to radiation from sources within a practice that are not required by or directly related to their work have the same level of protection against such exposure as members of the public.
      6. Employers, registrants and licensees shall take such administrative actions as are necessary to ensure that workers are informed that ensuring protection and safety is an integral part of a general occupational health and safety programme in which they have specific obligations and responsibilities for their own protection and the protection of others against radiation exposure and for the safety of sources.
      7. Employers, registrants and licensees shall record any report received from a worker that identifies circumstances that could affect compliance with the requirements of these Standards, and shall take appropriate action.
      8. Nothing in these Standards shall be construed as relieving employers from complying with applicable national and local laws and regulations governing hazards in the workplace.
      9. Employers, registrants and licensees shall facilitate compliance by workers with the requirements of these Standards.
      Requirement 22: Compliance by workers
      Workers shall fulfil their obligations and carry out their duties for protection and safety.
      1. Workers:
        1. Shall follow any applicable rules and procedures for protection and safety as specified by the employer, registrant or licensee;
        2. Shall use properly the monitoring equipment and personal protective equipment provided;
        3. Shall cooperate with the employer, registrant or licensee with regard to protection and safety, and programmes for workers’ health surveillance and programmes for dose assessment;
        4. Shall provide to the employer, registrant or licensee such information on their past and present work that is relevant for ensuring effective and comprehensive protection and safety for themselves and others;
        5. Shall abstain from any wilful action that could put themselves or others in situations that would not be in accordance with the requirements of these Standards;
        6. Shall accept such information, instruction and training in protection and safety as will enable them to conduct their work in accordance with the requirements of these Standards.
      2. A worker who identifies circumstances that could adversely affect protection and safety shall report such circumstances to the employer, registrant or licensee as soon as possible.
      Requirement 23: Cooperation between employers and registrants and licensees
      Employers and registrants and licensees shall cooperate to the extent necessary for compliance by all responsible parties with the requirements for protection and safety.
      1. If workers are engaged in work that involves or that could involve a source that is not under the control of their employer, the registrant or licensee responsible for the source and the employer shall cooperate to the extent necessary for compliance by both parties with the requirements of these Standards.
      2. Cooperation between the employer and the registrant or licensee shall include, where appropriate:
        1. The development and use of specific restrictions on exposure and other means of ensuring that the measures for protection and safety for workers who are engaged in work that involves or could involve a source that is not under the control of their employer are at least as good as those for employees of the registrant or licensee;
        2. Specific assessments of the doses received by workers as specified in (a) above;
        3. A clear allocation and documentation of the responsibilities of the employer and those of the registrant or licensee for protection and safety.
      3. As part of the cooperation between parties, the registrant or licensee responsible for the source or for the exposure as appropriate:
        1. Shall obtain from the employers, including self-employed persons, the previous occupational exposure history of workers as specified in para. 3.103, and any other necessary information;
        2. Shall provide appropriate information to the employer, including any available information relevant for compliance with the requirements of these Standards that the employer requests;
        3. Shall provide both the worker and the employer with the relevant exposure records.
      Requirement 24: Arrangements under the radiation protection programme
      Employers, registrants and licensees shall establish and maintain organizational, procedural and technical arrangements for the designation of controlled areas and supervised areas, for local rules and for monitoring of the workplace, in a radiation protection programme for occupational exposure.
      Classification of areas: Controlled areas
      1. Registrants and licensees shall designate as a controlled area any area32 in which specific measures for protection and safety are or could be required for:
        1. Controlling exposures or preventing the spread of contamination in normal operation;
        2. Preventing or limiting the likelihood and magnitude of exposures in anticipated operational occurrences and accident conditions.
      2. Cooperation between the employer and the registrant or licensee shall include, where appropriate:
        1. The development and use of specific restrictions on exposure and other means of ensuring that the measures for protection and safety for workers who are engaged in work that involves or could involve a source that is not under the control of their employer are at least as good as those for employees of the registrant or licensee;
        2. Specific assessments of the doses received by workers as specified in (a) above;
        3. A clear allocation and documentation of the responsibilities of the employer and those of the registrant or licensee for protection and safety.
      3. As part of the cooperation between parties, the registrant or licensee responsible for the source or for the exposure as appropriate:
        1. Shall obtain from the employers, including self-employed persons, the previous occupational exposure history of workers as specified in para. 3.103, and any other necessary information;
        2. Shall provide appropriate information to the employer, including any available information relevant for compliance with the requirements of these Standards that the employer requests;
        3. Shall provide both the worker and the employer with the relevant exposure records.
      Classification of areas: Supervised areas
      1. Registrants and licensees shall designate as a supervised area any area not already designated as a controlled area but for which occupational exposure conditions need to be kept under review, even though specific measures for protection and safety are not normally needed.
      2. Registrants and licensees, taking into account the nature, likelihood and magnitude of exposures or contamination in the supervised areas:
        1. Shall delineate the supervised areas by appropriate means;
        2. Shall display approved signs, as appropriate, at access points to supervised areas;
        3. Shall periodically review conditions to assess whether there is any need for further measures for protection and safety or any need for changes to the boundaries of supervised areas.
      3. Employers, registrants and licensees shall minimize the need to rely on administrative controls and personal protective equipment for protection and safety by providing well engineered controls and satisfactory working conditions, in accordance with the following hierarchy of preventive measures:
        1. Engineered controls;
        2. Administrative controls;
        3. Personal protective equipment.
      Local rules and procedures and personal protective equipment
      1. Employers, registrants and licensees shall minimize the need to rely on administrative controls and personal protective equipment for protection and safety by providing well engineered controls and satisfactory working conditions, in accordance with the following hierarchy of preventive measures:
        1. Engineered controls;
        2. Administrative controls;
        3. Personal protective equipment.
      2. Registrants and licensees, taking into account the nature, likelihood and magnitude of exposures or contamination in the supervised areas:
        1. Shall delineate the supervised areas by appropriate means;
        2. Shall display approved signs, as appropriate, at access points to supervised areas;
        3. Shall periodically review conditions to assess whether there is any need for further measures for protection and safety or any need for changes to the boundaries of supervised areas.
      3. Employers, registrants and licensees shall minimize the need to rely on administrative controls and personal protective equipment for protection and safety by providing well engineered controls and satisfactory working conditions, in accordance with the following hierarchy of preventive measures:
        1. Engineered controls;
        2. Administrative controls;
        3. Personal protective equipment.
      4. Employers, registrants and licensees, in consultation with workers, or through their representatives where appropriate:
        1. Shall establish in writing local rules and procedures that are necessary for protection and safety for workers and other persons;
        2. Shall include in the local rules and procedures any relevant investigation level or authorized level, and the procedures to be followed in the event that any such level is exceeded;
        3. Shall make the local rules and procedures and the measures for protection and safety known to those workers to whom they apply and to other persons who may be affected by them;
        4. Shall ensure that any work in which workers are or could be subject to occupational exposure is adequately supervised and shall take all reasonable steps to ensure that the rules, procedures, and measures for protection and safety are observed;
        5. Shall designate, as appropriate, a radiation protection officer in accordance with criteria established by the regulatory body.
      5. Employers, registrants and licensees shall ensure that:
        1. Workers are provided with suitable and adequate personal protective equipment that meets relevant standards or specifications, including as appropriate:
          1. Protective clothing;
          2. Respiratory protective equipment the characteristics of which are made known to the users;
          3. Protective aprons, protective gloves and organ shields.
        2. Where appropriate, workers receive adequate instruction in the proper use of respiratory protective equipment, including testing for good fit.
        3. Tasks requiring the use of certain personal protective equipment are assigned only to workers who on the basis of medical advice are capable of safely sustaining the extra effort necessary.
        4. All personal protective equipment, including equipment for use in an emergency, is maintained in proper condition and, if appropriate, is tested at regular intervals.
        5. If the use of personal protective equipment is considered for any given task, account is taken of any additional exposure that could result owing to the additional time taken or the inconvenience, and of any non-radiological risks that might be associated with using personal protective equipment while performing the task.
      Monitoring of the workplace
      1. Registrants and licensees, in cooperation with employers where appropriate, shall establish, maintain and keep under review a programme for workplace monitoring under the supervision of a radiation protection officer or qualified expert.
      2. The type and frequency of workplace monitoring:
        1. Shall be sufficient to enable:
          1. Evaluation of the radiological conditions in all workplaces;
          2. Assessment of exposures in controlled areas and supervised areas;
          3. Review of the classification of controlled areas and supervised areas.
        2. Shall be based on dose rate, activity concentration in air and surface contamination, and their expected fluctuations, and on the likelihood and magnitude of exposures in anticipated operational occurrences and accident conditions.
      3. Registrants and licensees, in cooperation with employers where appropriate, shall maintain records of the findings of the workplace monitoring programme. The findings of the workplace monitoring programme shall be made available to workers, through their representatives where appropriate.
      Requirement 25: Assessment of occupational exposure and workers’ health surveillance
      Employers, registrants and licensees shall be responsible for making arrangements for assessment and recording of occupational exposures and for workers’ health surveillance.
      Assessment of occupational exposure
      1. Employers, as well as self-employed persons, and registrants and licensees shall be responsible for making arrangements for assessment of the occupational exposure of workers, on the basis of individual monitoring where appropriate, and shall ensure that arrangements are made with authorized or approved dosimetry service providers that operate under a quality management system.
      2. For any worker who usually works in a controlled area, or who occasionally works in a controlled area and may receive a significant dose from occupational exposure, individual monitoring shall be undertaken where appropriate, adequate and feasible. In cases where individual monitoring of the worker is inappropriate, inadequate or not feasible, the occupational exposure shall be assessed on the basis of the results of workplace monitoring and information on the locations and durations of exposure of the worker33.
      3. For any worker who regularly works in a supervised area or who enters a controlled area only occasionally, the occupational exposure shall be assessed on the basis of the results of workplace monitoring or individual monitoring, as appropriate.
      4. Employers shall ensure that workers who could be subject to exposure due to contamination are identified, including workers who use respiratory protective equipment. Employers shall arrange for appropriate monitoring to the extent necessary to demonstrate the effectiveness of the measures for protection and safety and to assess intakes of radionuclides and the committed effective doses.
      Records of occupational exposure
      1. Employers, registrants and licensees shall maintain records of occupational exposure34 for every worker for whom assessment of occupational exposure is required in paras 3.99–3.102.
      2. Records of occupational exposure for each worker shall be maintained during and after the worker’s working life, at least until the former worker attains or would have attained the age of 75 years, and for not less than 30 years after cessation of the work in which the worker was subject to occupational exposure.
      3. Records of occupational exposure shall include:
        1. Information on the general nature of the work in which the worker was subject to occupational exposure;
        2. Information on dose assessments, exposures and intakes at or above the relevant recording levels specified by the regulatory body and the data upon which the dose assessments were based;
        3. When a worker is or has been exposed while in the employ of more than one employer, information on the dates of employment with each employer and on the doses, exposures and intakes in each such employment;
        4. Records of any assessments made of doses, exposures and intakes due to actions taken in an emergency or due to accidents or other incidents, which shall be distinguished from assessments of doses, exposures and intakes due to normal conditions of work and which shall include references to reports of any relevant investigations.
      4. Employers, registrants and licensees:
        1. Shall provide workers with access to records of their own occupational exposure;
        2. Shall provide the supervisor of the programme for workers’ health surveillance, the regulatory body and the relevant employer with access to workers’ records of occupational exposure;
        3. Shall facilitate the provision of copies of workers’ exposure records to new employers when workers change employment;
        4. Shall make arrangements for the retention of exposure records for former workers by the employer, registrant or licensee, as appropriate;
        5. Shall, in complying with (a)–(d) above, give due care and attention to maintaining the confidentiality of records.
      5. If employers, registrants and licensees cease to conduct activities in which workers are subject to occupational exposure, they shall make arrangements for the retention of workers’ records of occupational exposure by the regulatory body or a State registry, or by a relevant employer, registrant or licensee, as appropriate.
      Workers’ health surveillance
      1. Programmes for workers’ health surveillance as required in para. 3.76(f):
        1. Shall be based on the general principles of occupational health [19];
        2. Shall be designed to assess the initial fitness and continuing fitness of workers for their intended tasks.
      2. If one or more workers are to be engaged in work in which they are or could be exposed to radiation from a source that is not under the control of their employer, the registrant or licensee responsible for the source shall, as a precondition for the engagement of such workers, make with the employer any special arrangements for workers’ health surveillance that are needed to comply with the rules established by the regulatory body or other relevant authority.
      Requirement 26: Information, instruction and training
      Employers, registrants and licensees shall provide workers with adequate information, instruction and training for protection and safety.
      1. Employers, in cooperation with registrants and licensees:
        1. Shall provide all workers with adequate information on health risks due to their occupational exposure in normal operation, anticipated operational occurrences and accident conditions, adequate instruction and training and periodic retraining in protection and safety, and adequate information on the significance of their actions for protection and safety;
        2. Shall provide those workers who could be involved in or affected by the response to an emergency with appropriate information, and adequate instruction and training and periodic retraining, for protection and safety;
        3. Shall maintain records of the training provided to individual workers.
      Requirement 27: Conditions of service
      Employers, registrants and licensees shall not offer benefits as substitutes for measures for protection and safety.
      1. The conditions of service of workers shall be independent of whether they are or could be subject to occupational exposure. Special compensatory arrangements, or preferential consideration with respect to salary, special insurance coverage, working hours, length of vacation, additional holidays or retirement benefits, shall neither be granted nor be used as substitutes for measures for protection and safety in accordance with the requirements of these Standards.
      2. Employers shall make all reasonable efforts to provide workers with suitable alternative employment in circumstances for which it has been determined, either by the regulatory body or in the framework of the programme for workers’ health surveillance in accordance with the requirements of these Standards, that workers, for health reasons, may no longer continue in employment in which they are or could be subject to occupational exposure.
      Requirement 28: Special arrangements for protection and safety for female workers and for persons under 18 years of age undergoing training
      Employers, registrants and licensees shall make special arrangements for female workers, as necessary, for protection of the embryo or fetus and breastfed infants. Employers, registrants and licensees shall make special arrangements for protection and safety for persons under 18 years of age who are undergoing training.
      1. Employers, in cooperation with registrants and licensees, shall provide female workers who are liable to enter controlled areas or supervised areas or who may undertake emergency duties with appropriate information on:
        1. The risk to the embryo or fetus due to exposure of a pregnant woman;
        2. The importance for a female worker of notifying her employer as soon as possible if she suspects that she is pregnant35 or if she is breast-feeding;
        3. The risk of health effects for a breastfed infant due to ingestion of radioactive substances.
      2. Notification of the employer by a female worker if she suspects that she is pregnant or if she is breast-feeding shall not be considered a reason to exclude the female worker from work. The employer of a female worker, who has been notified of her suspected pregnancy or that she is breast-feeding, shall adapt the working conditions in respect of occupational exposure so as to ensure that the embryo or fetus or the breastfed infant is afforded the same broad level of protection as is required for members of the public.
      3. Employers, registrants and licensees shall ensure that no person under the age of 16 years is or could be subject to occupational exposure.
      4. Employers, registrants and licensees shall ensure that persons under the age of 18 years are allowed access to a controlled area only under supervision and only for the purpose of training for employment in which they are or could be subject to occupational exposure or for the purpose of studies in which sources are used.
    • PUBLIC EXPOSURE
      Scope
      1. The requirements in respect of public exposure in planned exposure situations (paras 3.118–3.144) apply to public exposure due to a practice or a source within a practice, as referred to in paras 3.1–3.3. For exposure due to natural sources, such requirements apply only to the types of public exposure specified in para. 3.4(a) and (b).
      Requirement 29: Responsibilities of the government and the regulatory body specific to public exposure
      Employers, registrants and licensees shall make special arrangements for female workers, as necessary, for protection of the embryo or fetus and breastfed infants. Employers, registrants and licensees shall make special arrangements for protection and safety for persons under 18 years of age who are undergoing training.
      1. The government or the regulatory body shall establish the responsibilities of registrants and licensees, of suppliers, and of providers of consumer products36 in relation to the application of requirements for public exposure in planned exposure situations.
      2. The government or the regulatory body shall establish and enforce requirements for the optimization of protection and safety for situations in which individuals are or could be subject to public exposure.
      3. The government or the regulatory body shall establish or approve constraints on dose and constraints on risk to be used in the optimization of protection and safety for members of the public. When establishing or approving constraints in respect of a source within a practice, the government or the regulatory body shall take into account, as appropriate:
        1. The characteristics of the source and of the practice that are of relevance for public exposure;
        2. Good practice in the operation of similar sources;
        3. Dose contributions from other authorized practices or from possible future authorized practices37, estimated at the design and planning stage, so that the total dose to members of the public is not expected to exceed the dose limit at any time after the start of operation of the source;
        4. The views of interested parties.
      4. The government or the regulatory body shall establish, and the regulatory body shall enforce compliance with, the dose limits specified in Schedule III for public exposure.
      5. Before authorization of a new or modified practice, the regulatory body shall require the submission of, and shall review, the safety assessments (paras 3.29–3.36) and other design related documents from the responsible parties that address the optimization of protection and safety, the design criteria and the design features relating to the assessment of exposure and potential exposure of members of the public.
      6. The regulatory body shall establish or approve operational limits and conditions relating to public exposure, including authorized limits for discharges. These operational limits and conditions:
        1. Shall be used by registrants and licensees as the criteria for demonstration of compliance after the commencement of operation of a source;
        2. Shall correspond to doses below the dose limits with account taken of the results of optimization of protection and safety;
        3. Shall reflect good practice in the operation of similar facilities or activities;
        4. Shall allow for operational flexibility;
        5. Shall take into account the results of the prospective assessment for radiological environmental impacts that is undertaken in accordance with requirements of the regulatory body (see paras 3.9(e) and 3.15(d)).
      7. When a source within a practice could cause public exposure outside the territory or other area under the jurisdiction or control of the State in which the source is located, the government or the regulatory body:
        1. Shall ensure that the assessment for radiological impacts includes those impacts outside the territory or other area under the jurisdiction or control of the State;
        2. Shall, to the extent possible, establish requirements for the control of discharges;
        3. Shall arrange with the affected State the means for the exchange of information and consultations, as appropriate.
      Requirement 30: Responsibilities of relevant parties specific to public exposure
      Relevant parties shall apply the system of protection and safety to protect members of the public against exposure.
      General considerations
      1. Registrants and licensees, in cooperation with suppliers and with providers of consumer products, shall apply the requirements of these Standards and shall verify and demonstrate compliance with them, as specified by the regulatory body, in relation to any public exposure delivered by a source for which they have responsibility.
      2. Registrants and licensees, in cooperation with suppliers, in applying the principle of optimization of protection and safety in the design, planning, operation and decommissioning of a source (or for closure and the post-closure period for waste disposal facilities), shall take into account:
        1. Possible changes in any conditions that could affect exposure of members of the public, such as changes in the characteristics and use of the source, changes in environmental dispersion conditions, changes in exposure pathways or changes in values of parameters used for the determination of the representative person;
        2. Good practice in the operation of similar sources or the conduct of similar practices;
        3. Possible buildup and accumulation in the environment of radioactive substances from discharges during the lifetime of the source;
        4. Uncertainties in the assessment of doses, especially uncertainties in contributions to doses if the source and the representative person are separated in space or in time.
      3. Registrants and licensees, for sources under their responsibility, shall establish, implement and maintain:
        1. Policies, procedures and organizational arrangements for protection and safety in relation to public exposure, in accordance with the requirements of these Standards.
        2. Measures for ensuring:
          1. Optimization of protection and safety;
          2. Limitation of exposure of members of the public from such sources, in accordance with the authorization.
        3. Measures for ensuring the safety of such sources.
        4. Provision for suitable and adequate resources (including facilities, equipment and services) for the protection and safety of members of the public, commensurate with the likelihood and magnitude of exposures.
        5. Programmes for appropriate training of personnel having functions relevant to protection and safety of members of the public, as well as periodic retraining as required, to ensure the necessary level of competence.
        6. Provision for appropriate monitoring equipment, monitoring programmes and methods for assessing public exposure.
        7. Adequate records of monitoring programmes.
        8. Emergency plans, emergency procedures and emergency arrangements, in accordance with the nature and magnitude of the radiation risks associated with the sources.
      Visitors
      1. Registrants and licensees, in cooperation with employers where appropriate:
        1. Shall apply the relevant requirements of these Standards in respect of public exposure for visitors to a controlled area or a supervised area;
        2. Shall ensure that visitors are accompanied in any controlled area by a person who knows the measures for protection and safety for the controlled area;
        3. Shall provide adequate information and instructions to visitors before they enter a controlled area or a supervised area, so as to provide for protection and safety for visitors and for other individuals who could be affected by their actions;
        4. Shall ensure that adequate control is maintained over the entry of visitors to a controlled area or a supervised area, including the use of signs for such areas.
      External exposure and contamination in areas accessible to members of the public
      1. Registrants and licensees shall ensure that if a source can give rise to external exposure of members of the public:
        1. The floor plans and arrangements of equipment for all new installations utilizing such sources, as well as all significant modifications to existing installations, are subject, as appropriate, to review and approval by the regulatory body prior to commissioning;
        2. Shielding and other measures for protection and safety, including access control, are provided as appropriate for restricting public exposure, in particular at open sites such as for some applications of industrial radiography.
      2. Registrants and licensees shall ensure, as appropriate, that:
        1. Specific provisions for confinement are established for the design and operation of a source that could cause the spread of contamination in areas that are accessible to members of the public;
        2. Measures for protection and safety are implemented for restricting public exposure due to contamination in areas within a facility that are accessible to members of the public.
      Requirement 31: Radioactive waste and discharges
      Relevant parties shall ensure that radioactive waste and discharges of radioactive material to the environment are managed in accordance with the authorization.
      Radioactive waste
      1. Registrants and licensees, in cooperation with suppliers, as appropriate:
        1. Shall ensure that any radioactive waste generated is kept to the minimum practicable in terms of both activity and volume;
        2. Shall ensure that radioactive waste is managed in accordance with the requirements of these Standards and the requirements of other applicable IAEA standards, and in accordance with the relevant authorization;
        3. Shall ensure that there is separate processing of radioactive waste of different types, where warranted by differences in factors such as radionuclide content, half-life, activity concentration, volume, and physical and chemical properties, taking into account the available options for storage and disposal of radioactive waste, without precluding the mixing of radioactive waste for purposes of protection and safety;
        4. Shall ensure that activities for the predisposal management of and for the disposal of radioactive waste are conducted in accordance with the requirements of applicable IAEA standards38, and in accordance with the authorization;
        5. Shall maintain an inventory of all radioactive waste that is generated, stored, transferred or disposed of;
        6. Shall develop and implement a strategy for radioactive waste management and shall include appropriate evidence that protection and safety is optimized.
      Discharges
      1. Registrants and licensees, in cooperation with suppliers, in applying for an authorization for discharges, as appropriate:
        1. Shall determine the characteristics and activity of the material to be discharged, and the possible points and methods of discharge;
        2. Shall determine by an appropriate pre-operational study all significant exposure pathways by which discharged radionuclides could give rise to exposure of members of the public;
        3. Shall assess the doses to the representative person due to the planned discharges;
        4. Shall consider the radiological environmental impacts in an integrated manner with features of the system of protection and safety, as required by the regulatory body;
        5. Shall submit to the regulatory body the findings of (a)–(d) above as an input to the establishment by the regulatory body, in accordance with para. 3.123, of authorized limits on discharges and conditions for their implementation.
      2. Registrants and licensees shall ensure that operational limits and conditions relating to public exposure are met in accordance with paras 3.123 and 3.124.
      3. Registrants and licensees shall review and modify their discharge control measures, as appropriate and in agreement with the regulatory body, taking into account:
        1. Operating experience;
        2. Any changes in exposure pathways or in the characteristics of the representative person that could affect the assessment of doses due to the discharges.
      Requirement 32: Monitoring and reporting
      The regulatory body and relevant parties shall ensure that programmes for source monitoring and environmental monitoring are in place and that the results from the monitoring are recorded and are made available.
      1. The regulatory body shall be responsible, as appropriate, for:
        1. Review and approval of monitoring programmes of registrants and licensees, which shall be sufficient for:
          1. Verifying compliance with the requirements of these Standards in respect of public exposure in planned exposure situations;
          2. Assessing doses from public exposure.
        2. Review of periodic reports on public exposure (including results of monitoring programmes and dose assessments) submitted by registrants and licensees.
        3. Making provision for an independent monitoring programme.
        4. Assessment of the total public exposure due to authorized sources and practices in the State on the basis of monitoring data provided by registrants and licensees and with the use of data from independent monitoring and assessments.
        5. Making provision for maintaining records of discharges, results of monitoring programmes and results of assessments of public exposure.
        6. Verification of compliance of an authorized practice with the requirements of these Standards for the control of public exposure.
      2. The regulatory body shall publish or shall make available on request, as appropriate, results from source monitoring and environmental monitoring programmes and assessments of doses from public exposure.
      3. Registrants and licensees shall, as appropriate:
        1. Establish and implement monitoring programmes to ensure that public exposure due to sources under their responsibility is adequately assessed and that the assessment is sufficient to verify and demonstrate compliance with the authorization. These programmes shall include monitoring of the following, as appropriate:
          1. External exposure due to such sources;
          2. Discharges;
          3. Radioactivity in the environment;
          4. Other parameters important for the assessment of public exposure.
        2. Maintain appropriate records of the results of the monitoring programmes and estimated doses to members of the public.
        3. Report or make available to the regulatory body the results of the monitoring programme at approved intervals, including, as applicable, the levels and composition of discharges, dose rates at the site boundary and in premises open to members of the public, results of environmental monitoring and retrospective assessments of doses to the representative person.
        4. Report promptly to the regulatory body any levels exceeding the operational limits and conditions relating to public exposure, including authorized limits on discharges, in accordance with reporting criteria established by the regulatory body.
        5. Report promptly to the regulatory body any significant increase in dose rate or concentrations of radionuclides in the environment that could be attributed to the authorized practice, in accordance with reporting criteria established by the regulatory body.
        6. Establish and maintain a capability to conduct monitoring in an emergency in the event of unexpected increases in radiation levels or in concentrations of radionuclides in the environment due to an accident or other unusual event attributed to the authorized source or facility.
        7. Verify the adequacy of the assumptions made for the assessment of public exposure and the assessment for radiological environmental impacts.
        8. Publish or make available on request, as appropriate, results from source monitoring and environmental monitoring programmes and assessments of doses from public exposure.
      Requirement 33: Consumer products
      1. Providers of consumer products shall ensure that consumer products are not made available to the public unless the justification of their use by members of the public has been approved by the government or the regulatory body, and either their use has been exempted on the basis of the criteria specified in Schedule I or their provision to the public has been authorized.
      2. Upon receipt of a request for authorization to provide consumer products to the public, the regulatory body:
        1. Shall require the provider of the consumer product to provide documents to demonstrate compliance with the requirements in paras 3.138–3.144;
        2. Shall verify the assessments and the selection of parameters presented in the request for authorization;
        3. Shall determine whether the end use of the consumer product can be exempted;
        4. Shall authorize the provision to the public of the consumer product, where appropriate, subject to specific conditions of authorization.
      3. Providers of consumer products:
        1. Shall comply with the conditions of the authorization to provide consumer products to the public;
        2. Shall ensure that consumer products comply with the requirements of these Standards;
        3. Shall plan for appropriate arrangements for the servicing, maintenance, recycling or disposal of consumer products.
      4. The design and manufacture of consumer products, with regard to features that could affect exposure during normal handling, transport and use, as well as in the event of mishandling, misuse, accident or disposal, shall be subject to the optimization of protection and safety. In this regard, designers, manufacturers and other providers of consumer products shall take into account the following:
        1. The various radionuclides that could be used in consumer products and their radiation types, energies, activities and half-lives;
        2. The chemical and physical forms of the radionuclides that could be used in consumer products and their significance for protection and safety in normal conditions and abnormal conditions;
        3. The containment and shielding of radioactive substances in consumer products and access to these radioactive substances in normal conditions and abnormal conditions;
        4. The need for servicing or repair of consumer products and ways in which this could be done;
        5. Relevant experience with similar consumer products.
      5. Providers of consumer products shall ensure that:
        1. Where practicable, a legible label is firmly affixed to a visible surface of each consumer product that:
          1. States that the consumer product contains radioactive substances and identifies the radionuclides and their activities;
          2. States that the provision of the consumer product to the public has been authorized by the regulatory body;
          3. Provides information on required or recommended options for recycling or disposal.
        2. The information specified in (a) above is also printed legibly on the retail packaging of the consumer product.
      6. Providers of consumer products shall provide clear and appropriate information and instructions with each consumer product on:
        1. Correct installation, use and maintenance of the consumer product;
        2. Servicing and repair;
        3. The radionuclides and their activities at a specified date;
        4. Dose rates in normal operation and during servicing and repair;
        5. Required or recommended options for recycling or disposal.
      7. Providers of consumer products shall provide the consumer product retailers with appropriate information on safety and instructions on their transport and storage.
    • MEDICAL EXPOSURE
      Scope
      1. The requirements in respect of medical exposure in planned exposure situations (paras 3.146–3.185) apply to all medical exposures39, including intended, unintended and accidental exposures.
      2. Dose limits do not apply to medical exposures.
      Requirement 34: Responsibilities of the government specific to medical exposure
      1. The requirements in respect of medical exposure in planned exposure situations (paras 3.146–3.185) apply to all medical exposures39, including intended, unintended and accidental exposures.
      2. Dose limits do not apply to medical exposures.
      3. The government, in accordance with paras 2.13–2.28, shall ensure with regard to medical exposures that, as a result of consultation between the health authority, relevant professional bodies and the regulatory body, the relevant parties identified in paras 2.40 and 2.41 are authorized to assume their roles and responsibilities, and shall ensure that they are notified of their duties in relation to protection and safety for individuals undergoing medical exposures.
      4. The government shall ensure, as part of the responsibilities specified in para. 2.15, that as a result of consultation between the health authority, relevant professional bodies and the regulatory body, a set of diagnostic reference levels is established for medical exposures incurred in medical imaging, including image guided interventional procedures. In setting such diagnostic reference levels, account shall be taken of the need for adequate image quality, to enable the requirements of para. 3.169 to be fulfilled. Such diagnostic reference levels shall be based, as far as possible, on wide scale surveys or on published values that are appropriate for the local circumstances.
      5. The government shall ensure that, as a result of consultation between the health authority, relevant professional bodies and the regulatory body, the following are established:
        1. Dose constraints, to enable the requirements of paras 3.173 and 3.174, respectively, to be fulfilled for:
          1. Exposures of carers and comforters40;
          2. Exposures due to diagnostic investigations of volunteers participating in a programme of biomedical research.
        2. Criteria and guidelines for the release of patients who have undergone therapeutic radiological procedures using unsealed sources or patients who still retain implanted sealed sources.
      Requirement 35: Responsibilities of the regulatory body specific to medical exposure
      1. The regulatory body shall ensure that the authorization for medical exposures to be performed at a particular medical radiation facility allows personnel (radiological medical practitioners, medical physicists, medical radiation technologists and any other health professionals with specific duties in relation to the radiation protection of patients) to assume the responsibilities specified in these Standards only if they:
        1. Are specialized41 in the appropriate area42;
        2. Meet the respective requirements for education, training and competence in radiation protection, in accordance with para. 2.32;
        3. Are named in a list maintained up to date by the registrant or licensee.
      Requirement 36: Responsibilities of registrants and licensees specific to medical exposure
      1. Registrants and licensees shall ensure that no patient, whether symptomatic or asymptomatic, undergoes a medical exposure unless:
        1. It is a radiological procedure that has been requested by a referring medical practitioner and information on the clinical context has been provided, or it is part of an approved health screening programme;
        2. The medical exposure has been justified by means of consultation between the radiological medical practitioner and the referring medical practitioner, as appropriate, or it is part of an approved health screening programme;
        3. A radiological medical practitioner has assumed responsibility for protection and safety in the planning and delivery of the medical exposure as specified in para. 3.154(a);
        4. The patient or the patient’s legal authorized representative has been informed as appropriate of the expected diagnostic or therapeutic benefits of the radiological procedure as well as the radiation risks.
      2. Registrants and licensees shall ensure that no individual incurs a medical exposure as part of a programme of biomedical research unless the exposure has been approved by an ethics committee (or other institutional body that has been assigned functions similar to those of an ethics committee by the relevant authority) as required in para. 3.161 and a radiological medical practitioner has assumed responsibility as specified in para. 3.154(a). Registrants and licensees shall ensure that the requirements specified in para. 3.174 are fulfilled for the optimization of protection and safety for persons subject to exposure as part of a programme of biomedical research.
      3. Registrants and licensees shall ensure that no individual incurs a medical exposure as a carer or comforter unless he or she has received, and has indicated an understanding of, relevant information on radiation protection and information on the radiation risks prior to providing care and comfort to an individual undergoing a radiological procedure. Registrants and licensees shall ensure that the requirements specified in para. 3.173 are fulfilled for the optimization of protection and safety for any radiological procedure in which an individual acts as a carer or comforter.
      4. Registrants and licensees shall ensure that:
        1. The radiological medical practitioner performing or overseeing the radiological procedure has assumed responsibility for ensuring overall protection and safety for patients in the planning and delivery of the medical exposure, including the justification of the radiological procedure as required in paras 3.155–3.161 and the optimization of protection and safety, in cooperation with the medical physicist and the medical radiation technologist as required in paras 3.162–3.177;
        2. Radiological medical practitioners, medical physicists, medical radiation technologists and other health professionals with specific duties in relation to protection and safety for patients in a given radiological procedure are specialized in the appropriate area;
        3. Sufficient medical personnel and paramedical personnel are available as specified by the health authority;
        4. For therapeutic radiological procedures, the requirements of these Standards for calibration, dosimetry and quality assurance, including the acceptance and commissioning of medical radiological equipment, as specified in paras 3.167, 3.168(c), 3.170 and 3.171, are fulfilled by or under the supervision of a medical physicist;
        5. For diagnostic radiological procedures and image guided interventional procedures, the requirements of these Standards for medical imaging, calibration, dosimetry and quality assurance, including the acceptance and commissioning of medical radiological equipment, as specified in paras 3.167, 3.168(a) and (b), 3.169, 3.170 and 3.171, are fulfilled by or under the oversight of or with the documented advice of a medical physicist, whose degree of involvement is determined by the complexity of the radiological procedures and the associated radiation risks;
        6. Any delegation of responsibilities by a principal party is documented.
      Requirement 37: Justification of medical exposures
      1. Medical exposures shall be justified by weighing the diagnostic or therapeutic benefits43 that they are expected to yield against the radiation detriment that they might cause, with account taken of the benefits and the risks of available alternative techniques that do not involve medical exposure.
      2. Generic justification of a radiological procedure shall be carried out by the health authority in conjunction with appropriate professional bodies, and shall be reviewed from time to time, with account taken of advances in knowledge and technological developments.
      3. The justification of medical exposure for an individual patient shall be carried out by means of consultation between the radiological medical practitioner and the referring medical practitioner, as appropriate, with account taken, in particular for patients who are pregnant or breast-feeding or are paediatric, of:
        1. The appropriateness of the request;
        2. The urgency of the radiological procedure;
        3. The characteristics of the medical exposure;
        4. The characteristics of the individual patient;
        5. Relevant information from the patient’s previous radiological procedures.
      4. Relevant national or international referral guidelines shall be taken into account for the justification of the medical exposure of an individual patient in a radiological procedure.
      5. Justification for radiological procedures to be performed as part of a health screening programme for asymptomatic populations shall be carried out by the health authority in conjunction with appropriate professional bodies.
      6. Any radiological procedure on an asymptomatic individual that is intended to be performed for the early detection of disease, but not as part of an approved health screening programme, shall require specific justification for that individual by the radiological medical practitioner and the referring medical practitioner, in accordance with the guidelines of relevant professional bodies or the health authority. As part of this process, the individual shall be informed in advance of the expected benefits, risks and limitations of the radiological procedure.
      7. The medical exposure of volunteers as part of a programme of biomedical research is deemed to be not justified unless:
        1. It is in accordance with the provisions of the Helsinki Declaration [20] and takes into account the guidelines published by the Council for International Organizations of Medical Sciences [21], together with the recommendations of the ICRP [22];
        2. It is subject to approval by an ethics committee (or other institutional body that has been assigned functions similar to those of an ethics committee by the relevant authority), subject to any dose constraints that may be specified (as required in paras 3.149(a)(ii) and 3.174), and subject to applicable national regulations and local regulations.
      Requirement 38: Optimization of protection and safety
      Design considerations
      1. In addition to ensuring that the responsibilities stated in para. 3.49 are discharged, as applicable, registrants and licensees, in cooperation with suppliers, shall ensure that medical radiological equipment and software that could influence the delivery of medical exposure are used only if they conform to the applicable standards of the International Electrotechnical Commission and the International Organization for Standardization or to national standards adopted by the regulatory body.
      Operational considerations
      1. For diagnostic radiological procedures and image guided interventional procedures, the radiological medical practitioner, in cooperation with the medical radiation technologist and the medical physicist, and if appropriate with the radiopharmacist or radiochemist, shall ensure that the following are used:
        1. Appropriate medical radiological equipment and software, and, for nuclear medicine, appropriate radiopharmaceuticals;
        2. Appropriate techniques and parameters to deliver a medical exposure of the patient that is the minimum necessary to fulfil the clinical purpose of the radiological procedure, with account taken of relevant norms of acceptable image quality established by relevant professional bodies and of relevant diagnostic reference levels established in accordance with paras 3.148 and 3.169.
      2. For therapeutic radiological procedures, the radiological medical practitioner, in cooperation with the medical physicist and the medical radiation technologist, shall ensure that for each patient the exposure of volumes other than the planning target volume is kept as low as reasonably achievable consistent with delivery of the prescribed dose to the planning target volume within the required tolerances.
      3. For therapeutic radiological procedures in which radiopharmaceuticals are administered, the radiological medical practitioner, in cooperation with the medical physicist and the medical radiation technologist, and if appropriate with the radiopharmacist or radiochemist, shall ensure that for each patient the appropriate radiopharmaceutical with the appropriate activity is selected and administered, so that the radioactivity is primarily localized in the organ(s) of interest, while the radioactivity in the rest of the body is kept as low as reasonably achievable.
      4. Registrants and licensees shall ensure that the particular aspects of medical exposures are considered in the optimization process for:
        1. Paediatric patients subject to medical exposure;
        2. Individuals subject to medical exposure as part of an approved health screening programme;
        3. Volunteers subject to medical exposure as part of a programme of biomedical research;
        4. Relatively high doses44 to the patient;
        5. Exposure of the embryo or fetus, in particular for radiological procedures in which the abdomen or pelvis of the pregnant female patient is exposed to the useful radiation beam or could otherwise receive a significant dose;
        6. Exposure of a breastfed infant as a result of a female patient having undergone a radiological procedure with radiopharmaceuticals.
      Calibration
      1. In accordance with para. 3.154(d) and (e), the medical physicist shall ensure that:
        1. All sources giving rise to medical exposure are calibrated in terms of appropriate quantities using internationally accepted or nationally accepted protocols;
        2. Calibrations are carried out at the time of commissioning a unit prior to clinical use, after any maintenance procedure that could affect the dosimetry and at intervals approved by the regulatory body;
        3. Calibrations of radiation therapy units are subject to independent verification45 prior to clinical use;
        4. Calibration of all dosimeters used for dosimetry of patients and for the calibration of sources is traceable to a standards dosimetry laboratory.
      Dosimetry of patients
      1. Registrants and licensees shall ensure that dosimetry of patients is performed and documented by or under the supervision of a medical physicist, using calibrated dosimeters and following internationally accepted or nationally accepted protocols, including dosimetry to determine the following:
        1. For diagnostic radiological procedures, typical doses to patients for common procedures;
        2. For image guided interventional procedures, typical doses to patients;
        3. For therapeutic radiological procedures, absorbed doses to the planning target volume for each patient treated with external beam therapy and/or brachytherapy and absorbed doses to relevant tissues or organs as determined by the radiological medical practitioner;
        4. For therapeutic radiological procedures with unsealed sources, typical absorbed doses to patients.
      Diagnostic reference levels
      1. Registrants and licensees shall ensure that:
        1. Local assessments, on the basis of the measurements required in para. 3.168, are made at approved intervals for those radiological procedures for which diagnostic reference levels have been established (para. 3.148).
        2. A review is conducted to determine whether the optimization of protection and safety for patients is adequate, or whether corrective action is required if, for a given radiological procedure:
          1. Typical doses or activities exceed the relevant diagnostic reference level; or
          2. Typical doses or activities fall substantially below the relevant diagnostic reference level and the exposures do not provide useful diagnostic information or do not yield the expected medical benefit to the patient.
      Quality assurance for medical exposures
      1. Registrants and licensees, in applying the requirements of these Standards in respect of management systems, shall establish a comprehensive programme of quality assurance for medical exposures with the active participation of medical physicists, radiological medical practitioners, medical radiation technologists and, for complex nuclear medicine facilities, radiopharmacists and radiochemists, and in conjunction with other health professionals as appropriate. Principles established by the World Health Organization, the Pan American Health Organization and relevant professional bodies shall be taken into account.
      2. Registrants and licensees shall ensure that programmes of quality assurance for medical exposure include, as appropriate to the medical radiation facility:
        1. Measurements of the physical parameters of medical radiological equipment made by, or under the supervision of, a medical physicist:
          1. At the time of acceptance and commissioning of the equipment prior to its clinical use on patients;
          2. Periodically thereafter;
          3. After any major maintenance procedure that could affect protection and safety of patients;
          4. After any installation of new software or modification of existing software that could affect protection and safety of patients.
        2. Implementation of corrective actions if measured values of the physical parameters mentioned in (a) above are outside established tolerance limits.
        3. Verification of the appropriate physical and clinical factors used in radiological procedures.
        4. Maintaining records of relevant procedures and results.
        5. Periodic checks of the calibration and conditions of operation of dosimetry equipment and monitoring equipment.
      3. Registrants and licensees shall ensure that regular and independent audits are made of the programme of quality assurance for medical exposures, and that their frequency is in accordance with the complexity of the radiological procedures being performed and the associated risks.
      Dose constraints
      1. Registrants and licensees shall ensure that relevant dose constraints (para. 3.149(a)(i)) are used in the optimization of protection and safety in any radiological procedure in which an individual acts as a carer or comforter.
      2. Registrants and licensees shall ensure that dose constraints specified or approved by the ethics committee (or other institutional body that has been assigned functions similar to those of an ethics committee by the relevant authority) on a case by case basis as part of a proposal for biomedical research (para. 3.161) are used in the optimization of protection and safety for persons subject to exposure as part of a programme of biomedical research.
      Requirement 39: Pregnant or breast-feeding female patients
      Registrants and licensees and radiological medical practitioners shall ensure that protection and safety is optimized for each medical exposure.
      1. Registrants and licensees shall ensure that signs in appropriate languages are placed in public places, waiting rooms for patients, cubicles and other appropriate places, and that other means of communication are also used as appropriate46, to request female patients who are to undergo a radiological procedure to notify the radiological medical practitioner, medical radiation technologist or other personnel in the event that:
        1. She is or might be pregnant;
        2. She is breast-feeding and the scheduled radiological procedure includes the administration of a radiopharmaceutical.
      2. Registrants and licensees shall ensure that there are procedures in place for ascertaining the pregnancy status of a female patient of reproductive capacity before the performance of any radiological procedure that could result in a significant dose to the embryo or fetus, so that this information can be considered in the justification for the radiological procedure (paras 3.155 and 3.156) and in the optimization of protection and safety (para. 3.166).
      3. Registrants and licensees shall ensure that there are arrangements in place for establishing that a female patient is not currently breast-feeding before the performance of any radiological procedure involving the administration of a radiopharmaceutical that could result in a significant dose to a breastfed infant, so that this information can be considered in the justification for the radiological procedure (paras 3.155 and 3.157) and in the optimization of protection and safety (para. 3.166).
      Requirement 40: Release of patients after radionuclide therapy
      Registrants and licensees shall ensure that there are arrangements in place to ensure appropriate radiation protection for members of the public and for family members before a patient is released following radionuclide therapy.
      1. The radiological medical practitioner shall ensure that no patient who has undergone a therapeutic radiological procedure with a sealed source or an unsealed source is discharged from a medical radiation facility until it has been established by either a medical physicist or the facility’s radiation protection officer that:
        1. The activity of radionuclides in the patient is such that doses that could be received by members of the public and family members would be in compliance with the requirements set by the relevant authorities (para. 3.149(b)); and
        2. The patient or the legal guardian of the patient is provided with:
          1. Written instructions for keeping doses to persons in contact with or in the vicinity of the patient as low as reasonably achievable and for avoiding the spread of contamination;
          2. Information on the radiation risks.
      Requirement 41: Unintended and accidental medical exposures
      Registrants and licensees shall ensure that all practicable measures are taken to minimize the likelihood of unintended or accidental medical exposures. Registrants and licensees shall promptly investigate unintended or accidental medical exposures and, if appropriate, shall implement corrective actions.
      1. Registrants and licensees, in accordance with the relevant requirements of paras 2.51, 3.41–3.42 and 3.49–3.50, shall ensure that all practicable measures are taken to minimize the likelihood of unintended or accidental medical exposures arising from flaws in design and operational failures of medical radiological equipment, from failures of and errors in software, or as a result of human error.
      Investigation of unintended and accidental medical exposures
      1. Registrants and licensees shall promptly investigate any of the following unintended or accidental medical exposures:
        1. Any medical treatment delivered to the wrong individual or to the wrong tissue or organ of the patient, or using the wrong radiopharmaceutical, or with an activity, a dose or dose fractionation differing substantially from (over or under) the values prescribed by the radiological medical practitioner, or that could lead to unduly severe secondary effects;
        2. Any diagnostic radiological procedure or image guided interventional procedure in which the wrong individual or the wrong tissue or organ of the patient is subject to exposure;
        3. Any exposure for diagnostic purposes that is substantially greater than was intended;
        4. Any exposure arising from an image guided interventional procedure that is substantially greater than was intended;
        5. Any inadvertent exposure of the embryo or fetus in the course of performing a radiological procedure;
        6. Any failure of medical radiological equipment, failure of software or system failure, or accident, error, mishap or other unusual occurrence with the potential for subjecting the patient to a medical exposure that is substantially different from what was intended.
      2. Registrants and licensees shall, with regard to any unintended or accidental medical exposures investigated as required in para. 3.180:
        1. Calculate or estimate the doses received and the dose distribution within the patient;
        2. Indicate the corrective actions required to prevent the recurrence of such an unintended or accidental medical exposure;
        3. Implement all the corrective actions that are under their own responsibility;
        4. Produce and keep, as soon as possible after the investigation or as otherwise required by the regulatory body, a written record that states the cause of the unintended or accidental medical exposure and includes the information specified in (a)–(c) above, as relevant, and any other information as required by the regulatory body; and for significant unintended or accidental medical exposures or as otherwise required by the regulatory body, submit this written record, as soon as possible, to the regulatory body, and to the relevant health authority if appropriate;
        5. Ensure that the appropriate radiological medical practitioner informs the referring medical practitioner and the patient or the patient’s legal authorized representative of the unintended or accidental medical exposure.
      Requirement 42: Reviews and records
      Registrants and licensees shall ensure that radiological reviews are performed periodically at medical radiation facilities and that records are maintained.
      Radiological reviews
      1. Registrants and licensees shall ensure that radiological reviews are performed periodically by the radiological medical practitioners at the medical radiation facility, in cooperation with the medical radiation technologists and the medical physicists. The radiological review shall include an investigation and critical review of the current practical application of the radiation protection principles of justification and optimization for the radiological procedures that are performed in the medical radiation facility.
      Records
      1. Registrants and licensees shall maintain for a period as specified by the regulatory body and shall make available, as required, the following personnel records:
        1. Records of any delegation of responsibilities by a principal party (as required in para. 3.154(f));
        2. Records of training of personnel in radiation protection (as required in para. 3.150(b)).
      2. Registrants and licensees shall ensure that radiological reviews are performed periodically by the radiological medical practitioners at the medical radiation facility, in cooperation with the medical radiation technologists and the medical physicists. The radiological review shall include an investigation and critical review of the current practical application of the radiation protection principles of justification and optimization for the radiological procedures that are performed in the medical radiation facility.
      3. Registrants and licensees shall maintain for a period as specified by the regulatory body and shall make available, as required, the following personnel records:
        1. Records of any delegation of responsibilities by a principal party (as required in para. 3.154(f));
        2. Records of training of personnel in radiation protection (as required in para. 3.150(b)).
      4. Registrants and licensees shall maintain for a period as specified by the regulatory body and shall make available, as required, the following records of calibration, dosimetry and quality assurance:
        1. Records of the results of the calibrations and periodic checks of the relevant physical and clinical parameters selected during treatment of patients;
        2. Records of dosimetry of patients, as required in para. 3.168;
        3. Records of local assessments and reviews made with regard to diagnostic reference levels, as required in para. 3.169;
        4. Records associated with the quality assurance programme, as required in para. 3.171(d).
      5. Registrants and licensees shall maintain for a period as specified by the regulatory body and shall make available, as required, the following records for medical exposure:
        1. For diagnostic radiology, information necessary for retrospective assessment of doses, including the number of exposures and the duration of fluoroscopic radiological procedures;
        2. For image guided interventional procedures, information necessary for retrospective assessment of doses, including the duration of the fluoroscopic component and the number of images acquired;
        3. For nuclear medicine, the types of radiopharmaceutical administered and their activity;
        4. For external beam radiation therapy or brachytherapy, a description of the planning target volume, the absorbed dose to the centre of the planning target volume, and the maximum and minimum absorbed doses delivered to the planning target volume, or equivalent alternative information on absorbed doses to the planning target volume, and the absorbed doses to relevant tissues or organs as determined by the radiological medical practitioner; and in addition, for external beam radiation therapy, the dose fractionation and the overall treatment time;
        5. Exposure records for volunteers subject to medical exposure as part of a programme of biomedical research;
        6. Reports on investigations of unintended and accidental medical exposures (as required in para. 3.181(d)).
  4. EMERGENCY EXPOSURE SITUATIONS
    1. SCOPE
      1. The requirements for emergency exposure situations established in Section 4 apply to activities undertaken in preparedness for and in response to a nuclear or radiological emergency.
    2. GENERIC REQUIREMENTS
      Requirement 43: Emergency management system
      The government shall ensure that an integrated and coordinated emergency management system is established and maintained.
      1. The government shall ensure that an emergency management system is established and maintained on the territories and within the jurisdiction of the State for the purposes of emergency response to protect human life, health and the environment in the event of a nuclear or radiological emergency.
      2. The emergency management system shall be designed to be commensurate with the results of a hazard assessment [15] and to enable an effective emergency response to reasonably foreseeable events (including very low probability events) in connection with facilities or activities.
      3. The emergency management system shall be integrated, to the extent practicable, into an all-hazards emergency management system.
      4. The emergency management system shall provide for essential elements at the scene, and at the local, national and international level, as appropriate, including the following [15]:
        1. Hazard assessment;
        2. Development and exercising of emergency plans and emergency procedures;
        3. Clear allocation of responsibilities to persons and organizations having roles in the arrangements for emergency preparedness and response;
        4. Arrangements for efficient and effective cooperation and coordination among organizations;
        5. Reliable communication, including public information;
        6. Optimized protection strategies for the implementation and the termination of measures for the protection of members of the public who could be subject to exposure in an emergency, including relevant considerations for protection of the environment;
        7. Arrangements for the protection of emergency workers;
        8. Education and training, including training in radiation protection, of all persons involved in emergency response and exercising of emergency plans and emergency procedures;
        9. Preparations for the transition from emergency exposure situation to existing exposure situation;
        10. Arrangements for the medical response and the public health response in an emergency;
        11. Provision for individual monitoring and environmental monitoring and for dose assessment;
        12. Involvement of relevant parties and interested parties.
      5. The government shall ensure the coordination of its emergency arrangements and capabilities with the relevant international emergency arrangements.
    3. PUBLIC EXPOSURE
      Requirement 44: Preparedness and response for an emergency
      The government shall ensure that protection strategies are developed, justified and optimized at the planning stage, and that emergency response is undertaken by their timely implementation.
      1. The government shall ensure that protection strategies are developed, justified and optimized at the planning stage, by using scenarios based on the hazard assessment, for avoiding deterministic effects and reducing the likelihood of stochastic effects due to public exposure.
      2. Development of a protection strategy shall include, but shall not be limited to, the following three successive steps:
        1. A reference level expressed in terms of residual dose shall be set, typically an effective dose in the range of 20–100 mSv, that includes dose contributions via all exposure pathways. The protection strategy shall include planning for residual doses to be as low as reasonably achievable below the reference level, and the strategy shall be optimized.
        2. On the basis of the outcome of the optimization of the protection strategy, using the reference level, generic criteria for particular protective actions and other response actions, expressed in terms of projected dose or of dose that has been received, shall be developed. If the numerical values of the generic criteria47 are exceeded, those protective actions and other response actions, either individually or in combination, shall be implemented.
        3. Once the protection strategy has been optimized and a set of generic criteria has been developed, pre-established operational criteria for initiating the different parts of an emergency plan, primarily for the initial phase, shall be derived from the generic criteria. Operational criteria, such as on-scene conditions, operational intervention levels and emergency action levels, shall be expressed in terms of parameters or observable conditions. Arrangements shall be established in advance to revise these operational criteria, as appropriate, in an emergency, with account taken of the prevailing conditions as they evolve.
      3. Each protective action shall be justified in the context of the protection strategy.
      4. The government shall ensure that in making arrangements for emergency preparedness and response it is taken into consideration that emergencies are dynamic, that decisions taken early in the emergency response may influence subsequent actions, and that different geographical areas may have different prevailing conditions and there may be different requirements for the response.47 Table A–1 in the Annex (p. 380) provides a set of generic criteria for use in the protection strategy that are compatible with reference levels within a range of 20–100 mSv, and provides further details for specific actions in different time frames.
      5. The government shall ensure that the response in an emergency exposure situation is undertaken by the timely implementation of arrangements for emergency response, including but not limited to:
        1. Promptly taking protective actions and other response actions to avoid severe deterministic effects on the basis of observed conditions and, if possible, before any exposure occurs. Dose levels required to be used as generic criteria for preventing severe deterministic effects are given in Table IV.1 of Schedule IV (p. 372);
        2. Assessing the effectiveness of the protective actions and other response actions taken and modifying them as appropriate;
        3. Comparing residual doses with the applicable reference level, giving priority to those groups for whom residual doses exceed the reference level;
        4. Implementing further protection strategies as necessary, on the basis of prevailing conditions and available information.
    4. EXPOSURE OF EMERGENCY WORKERS
      Requirement 45: Arrangements for controlling the exposure of emergency workers
      The government shall establish a programme for managing, controlling and recording the doses received in an emergency by emergency workers.
      1. The government shall establish a programme for managing, controlling and recording the doses received in an emergency by emergency workers, which shall be implemented by response organizations and employers.
      2. The response organization and employers responsible for ensuring compliance with the requirements in paras 4.14–4.19 shall be specified in the emergency plan.
      3. In an emergency exposure situation, the relevant requirements for occupational exposure in planned exposure situations (paras 3.69–3.116) shall be applied for emergency workers, in accordance with a graded approach, except as required in para. 4.15.
      4. Response organizations and employers shall ensure that no emergency worker is subject to an exposure in an emergency in excess of 50 mSv other than:
        1. For the purposes of saving life or preventing serious injury;
        2. When undertaking actions to prevent severe deterministic effects and actions to prevent the development of catastrophic conditions that could significantly affect people and the environment; or
        3. When undertaking actions to avert a large collective dose.
      5. In the exceptional circumstances specified in para. 4.15, response organizations and employers shall make all reasonable efforts to keep doses to emergency workers below the values set out in Table IV.2 of Schedule IV (p. 373). In addition, emergency workers undertaking actions as a result of which their doses could approach or exceed the values set out in Table IV.2 of Schedule IV shall do so only when the expected benefits to others would clearly outweigh the risks to the emergency workers.
      6. Response organizations and employers shall ensure that emergency workers who undertake actions in which the doses received might exceed 50 mSv do so voluntarily48; that they have been clearly and comprehensively informed in advance of the associated health risks, as well as of available measures for protection and safety; and that they are, to the extent possible, trained in the actions that they may be required to take.
      7. Response organizations and employers shall take all reasonable steps to assess and record the doses received in an emergency by emergency workers. Information on the doses received and information concerning the associated health risks shall be communicated to the workers involved.
      8. Workers who receive doses in an emergency exposure situation shall not normally be precluded from incurring further occupational exposure. However, qualified medical advice shall be obtained before any further occupational exposure if such a worker has received a dose exceeding 200 mSv or at the request of the worker.
    5. TRANSITION FROM AN EMERGENCY EXPOSURE SITUATION TO AN EXISTING EXPOSURE SITUATION
      Requirement 46: Arrangements for the transition from an emergency exposure situation to an existing exposure situation
      The government shall ensure that arrangements are in place and are implemented as appropriate for the transition from an emergency exposure situation to an existing exposure situation.
      1. The government shall ensure that, as part of its overall emergency preparedness, arrangements are in place for the transition from an emergency exposure situation to an existing exposure situation. The arrangements shall take into account that different geographical areas may undergo the transition at different times. The responsible authority shall take the decision to make the transition to an existing exposure situation. The transition shall be made in a coordinated and orderly manner, by making any necessary transfer of responsibilities between organizations, with the involvement of relevant authorities and interested parties.
      2. Workers undertaking work such as repairs to plant and buildings or activities for radioactive waste management, or undertaking remedial actions for the decontamination of the site and surrounding areas, shall be subject to the relevant requirements for occupational exposure in planned exposure situations stated in Section 3.
  5. EXISTING EXPOSURE SITUATIONS
    • SCOPE
      1. The requirements for existing exposure situations in Section 5 apply to:
        1. Exposure due to contamination of areas by residual radioactive material deriving from:
          1. Past activities that were never subject to regulatory control or that were subject to regulatory control but not in accordance with the requirements of these Standards;
          2. A nuclear or radiological emergency, after an emergency has been declared to be ended (as required in para. 4.20).
        2. Exposure due to commodities, including food, feed, drinking water and construction materials, that incorporate radionuclides deriving from residual radioactive material as stated in para. 5.1(a).
        3. Exposure due to natural sources, including:
          1. 222Rn and its progeny and 220Rn and its progeny, in workplaces other than those workplaces for which exposure due to other radionuclides in the uranium decay chain or the thorium decay chain is controlled as a planned exposure situation, in dwellings and in other buildings with high occupancy factors for members of the public;
          2. Radionuclides of natural origin, regardless of activity concentration, in commodities, including food, feed, drinking water, agricultural fertilizer and soil amendments, and construction materials, and residual radioactive material in the environment;
          3. Materials, other than those stated in (c)(ii) above, in which the activity concentration of no radionuclide in either the uranium decay chain or the thorium decay chain exceeds 1 Bq/g and the activity concentration of 40K does not exceed 10 Bq/g;
          4. Exposure of aircrew and space crew to cosmic radiation.
    • GENERIC REQUIREMENTS
      Requirement 47: Responsibilities of the government specific to existing exposure situations
      The government shall ensure that existing exposure situations that have been identified are evaluated to determine which occupational exposures and public exposures are of concern from the point of view of radiation protection.
      1. The government shall ensure that, when an existing exposure situation is identified, responsibilities for protection and safety are assigned and appropriate reference levels are established.
      2. The government shall include in the legal and regulatory framework for protection and safety (see Section 2) provision for the management of existing exposure situations. The government, in the legal and regulatory framework, as appropriate:
        1. Shall specify the exposure situations that are included in the scope of existing exposure situations;49
        2. Shall specify the general principles underlying the protection strategies developed to reduce exposure when remedial actions and protective actions have been determined to be justified;50
        3. Shall assign responsibilities for the establishment and implementation of protection strategies to the regulatory body and to other relevant authorities51 and, as appropriate, to registrants, licensees and other parties involved in the implementation of remedial actions and protective actions;
        4. Shall provide for the involvement of interested parties in decisions regarding the development and implementation of protection strategies, as appropriate.
      3. The regulatory body or other relevant authority assigned to establish a protection strategy for an existing exposure situation shall ensure that it specifies:
        1. The objectives to be achieved by means of the protection strategy;
        2. Appropriate reference levels.
      4. The regulatory body or other relevant authority shall implement the protection strategy, including:
        1. Arranging for evaluation of the available remedial actions and protective actions for achieving the objectives, and for evaluation of the efficiency of the actions planned and implemented;
        2. Ensuring that information is available to individuals subject to exposure on potential health risks and on the means available for reducing their exposures and the associated risks.
    • PUBLIC EXPOSURE
      Scope
      1. The requirements in respect of public exposure in existing exposure situations (paras 5.7–5.23) apply to any public exposure arising from the situations specified in para. 5.1.

      Requirement 48: Justification for protective actions and optimization of protection and safety
      The government and the regulatory body or other relevant authority shall ensure that remedial actions and protective actions are justified and that protection and safety is optimized.
      1. The government and the regulatory body or other relevant authority shall ensure that the protection strategy for the management of existing exposure situations, established in accordance with paras 5.2 and 5.4, is commensurate with the radiation risks associated with the existing exposure situation; and that remedial actions or protective actions are expected to yield sufficient benefits to outweigh the detriments associated with taking them, including detriments in the form of radiation risks.52
      2. The regulatory body or other relevant authority and other parties responsible for remedial actions or protective actions shall ensure that the form, scale and duration of such actions are optimized. While this optimization process is intended to provide optimized protection for all individuals subject to exposure, priority shall be given to those groups for whom the dose exceeds the reference level. All reasonable steps shall be taken to prevent doses from remaining above the reference levels. Reference levels shall typically be expressed as an annual effective dose to the representative person in the range of 1–20 mSv or other corresponding quantity, the actual value depending on the feasibility of controlling the situation and on experience in managing similar situations in the past.
      3. The regulatory body or other relevant authority shall periodically review the reference levels to ensure that they remain appropriate in the light of the prevailing circumstances.
      Requirement 49: Responsibilities for remediation of areas with residual radioactive material
      The government shall ensure that provision is made for identifying those persons or organizations responsible for areas with residual radioactive material; for establishing and implementing remediation programmes and post-remediation control measures, if appropriate; and for putting in place an appropriate strategy for radioactive waste management.
      1. For the remediation of areas with residual radioactive material deriving from past activities or from a nuclear or radiological emergency (para. 5.1(a)), the government shall ensure that provision is made in the framework for protection and safety for:
        1. The identification of those persons or organizations responsible for the contamination of areas and those responsible for financing the remediation programme, and the determination of appropriate arrangements for alternative sources of funding if such persons or organizations are no longer present or are unable to meet their liabilities;
        2. The designation of persons or organizations responsible for planning, implementing and verifying the results of remedial actions;
        3. The establishment of any restrictions on the use of or access to the areas concerned before, during and, if necessary, after remediation;
        4. An appropriate system for maintaining, retrieval and amendment of records that cover the nature and the extent of contamination; the decisions made before, during and after remediation; and information on verification of the results of remedial actions, including the results of all monitoring programmes after completion of the remedial actions.
      2. The government shall ensure that a strategy for radioactive waste management is put in place to deal with any waste arising from the remedial actions and that provision for such a strategy is made in the framework for protection and safety.
      3. The persons or organizations responsible for the planning, implementation and verification of remedial actions shall, as appropriate, ensure that:
        1. A remedial action plan, supported by a safety assessment, is prepared and is submitted to the regulatory body or other relevant authority for approval.
        2. The remedial action plan is aimed at the timely and progressive reduction of the radiation risks and eventually, if possible, at the removal of restrictions on the use of or access to the area.
        3. Any additional doses received by members of the public as a result of the remedial actions are justified on the basis of the resulting net benefit, including consideration of the consequent reduction of the annual dose.
        4. In the choice of the optimized remediation option:
          1. Radiological impacts on people and the environment are considered together with non-radiological impacts on people and the environment, and with technical, societal and economic factors;
          2. The costs of the transport and management of radioactive waste, the radiation exposure of and health risks to the workers managing the radioactive waste, and any subsequent public exposure associated with its disposal are all taken into account.
        5. A mechanism for public information is in place and interested parties are involved in the planning, implementation and verification of the remedial actions, including any monitoring following remediation.
        6. A monitoring programme is established and implemented.
        7. A system for maintaining adequate records relating to the existing exposure situation and to actions taken for protection and safety is in place.
        8. Procedures are in place for reporting to the regulatory body or other relevant authority on any abnormal conditions relevant to protection and safety.
      4. The regulatory body, in accordance with para. 2.29, or other relevant authority shall take responsibility, in particular for:
        1. Review of the safety assessment submitted by the responsible person or organization, approval of the remedial action plan and of any subsequent changes to the remedial action plan, and granting of any necessary authorization;
        2. Establishment of criteria and methods for assessing safety;
        3. Review of work procedures, monitoring programmes and records;
        4. Review and approval of significant changes to procedures or equipment that may have radiological environmental impacts or that may alter the exposure conditions for workers taking remedial actions or for members of the public;
        5. Where necessary, establishment of regulatory requirements for control measures following remediation.
      5. The person or organization responsible for carrying out the remedial actions:
        1. Shall ensure that the work, including management of the radioactive waste arising, is conducted in accordance with the remedial action plan;
        2. Shall take responsibility for all aspects of protection and safety, including the conduct of a safety assessment;
        3. Shall monitor the area regularly during the remediation so as to verify levels of contamination, to verify compliance with the requirements for radioactive waste management, and to enable any unexpected levels of radiation to be detected and the remedial action plan to be modified accordingly, subject to approval by the regulatory body or other relevant authority;
        4. Shall perform a radiological survey after completion of remedial actions to demonstrate that the end point conditions, as established in the remedial action plan, have been met;
        5. Shall prepare and retain a final remediation report and shall submit a copy to the regulatory body or other relevant authority.
      6. After the remedial actions have been completed, the regulatory body or other relevant authority:
        1. Shall review, amend as necessary and formalize the type, extent and duration of any post-remediation control measures already identified in the remedial action plan, with due consideration of the residual radiation risks.
        2. Shall identify the person or organization responsible for any post-remediation control measures.
        3. Shall, where necessary, impose specific restrictions for the remediated area to control:
          1. Access by unauthorized persons;
          2. Removal of radioactive material or use of such material, including its use in commodities;
          3. Future use of the area, including the use of water resources and its use for the production of food or feed, and the consumption of food from the area.
        4. Shall periodically review conditions in the remediated area and, if appropriate, shall amend or remove any restrictions.
      7. The person or organization responsible for post-remediation control measures shall establish and maintain, for as long as required by the regulatory body or other relevant authority, an appropriate programme, including any necessary provision for monitoring, to verify the long term effectiveness of the completed remedial actions for areas in which controls are required after remediation.
      8. For those areas with long lasting residual radioactive material, in which the government has decided to allow habitation and the resumption of social and economic activities, the government, in consultation with interested parties, shall ensure that arrangements are in place, as necessary, for the continuing control of exposure with the aim of establishing conditions for sustainable living, including:
        1. Establishment of reference levels for protection and safety that are consistent with day to day life;
        2. Establishment of an infrastructure to support continuing ‘self-help protective actions’ in the affected areas, such as by the provision of information and advice, and by monitoring.
      9. The conditions prevailing after the completion of remedial actions, if the regulatory body or other relevant authority has imposed no restrictions or controls, shall be considered to constitute the background conditions for any new facilities and activities or for habitation on the land.
      Requirement 50: Public exposure due to radon indoors
      The government shall provide information on levels of radon indoors and the associated health risks and, if appropriate, shall establish and implement an action plan for controlling public exposure due to radon indoors.
      1. As part of its responsibilities, as required in para. 5.3, the government shall ensure that:
        1. Information is gathered on activity concentrations of radon in dwellings and other buildings with high occupancy factors for members of the public53 through appropriate means, such as representative radon surveys;
        2. Relevant information on exposure due to radon and the associated health risks, including the increased risks relating to smoking, is provided to the public and other interested parties.
      2. Where activity concentrations of radon that are of concern for public health are identified on the basis of the information gathered as required in para. 5.19(a), the government shall ensure that an action plan is established comprising coordinated actions to reduce activity concentrations of radon in existing buildings and in future buildings, which includes54:
        1. Establishing an appropriate reference level for 222Rn for dwellings and other buildings with high occupancy factors for members of the public, with account taken of the prevailing social and economic circumstances, that in general will not exceed an annual average activity concentration due to 222Rn of 300 Bq/m3 55;
        2. Reducing activity concentrations of 222Rn and consequent exposures to levels at which protection is optimized;
        3. Giving priority to actions to reduce activity concentrations of 222Rn in those situations for which such action is likely to be most effective56;
        4. Including in building codes appropriate preventive measures and corrective actions to prevent the ingress of 222Rn and to facilitate further actions wherever necessary.
      3. The government shall assign responsibility for:
        1. Establishing and implementing the action plan for controlling public exposure due to 222Rn indoors;
        2. Determining the circumstances under which actions are to be mandatory or are to be voluntary, with account taken of legal requirements and of the prevailing social and economic circumstances.
      Requirement 51: Exposure due to radionuclides in commodities
      The regulatory body or other relevant authority shall establish reference levels for exposure due to radionuclides in commodities.
      1. The regulatory body or other relevant authority shall establish specific reference levels for exposure due to radionuclides in commodities such as construction materials, food and feed, and in drinking water, each of which shall typically be expressed as, or be based on, an annual effective dose to the representative person that generally does not exceed a value of about 1 mSv.
      2. The regulatory body or other relevant authority shall consider the guideline levels for radionuclides in food traded internationally that could contain radioactive substances as a result of a nuclear or radiological emergency, which have been published by the Joint Food and Agriculture Organization of the United Nations/World Health Organization Codex Alimentarius Commission [23]. The regulatory body or other relevant authority shall consider the guideline levels for radionuclides contained in drinking water that have been published by the World Health Organization [24].
    • OCCUPATIONAL EXPOSURE
      Scope
      1. The requirements in respect of occupational exposure in existing exposure situations (paras 5.25–5.33) apply to any occupational exposure arising from the situations specified in para. 5.1.
      Requirement 52: Exposure in workplaces
      The regulatory body shall establish and enforce requirements for the protection of workers in existing exposure situations.
      1. The requirements in respect of public exposure stated in paras 5.7–5.9 shall be applied for protection and safety for workers in existing exposure situations, other than in those specific situations identified in paras 5.26–5.33.
      Remediation of areas with residual radioactive material
      1. Employers shall ensure that the exposure of workers undertaking remedial actions is controlled in accordance with the relevant requirements on occupational exposure in planned exposure situations as established in Section 3.
      Exposure due to radon in workplaces
      1. The regulatory body or other relevant authority shall establish a strategy for protection against exposure due to 222Rn in workplaces, including the establishment of an appropriate reference level for 222Rn. The reference level for 222Rn shall be set at a value that does not exceed an annual average activity concentration of 222Rn of 1000 Bq/m3, with account taken of the prevailing social and economic circumstances.57
      2. Employers shall ensure that activity concentrations of 222Rn in workplaces are as low as reasonably achievable below the reference level established in accordance with para. 5.27, and shall ensure that protection is optimized.
      3. If, despite all reasonable efforts by the employer to reduce activity concentrations of radon, the activity concentration of 222Rn in workplaces remains above the reference level established in accordance with para. 5.27, the relevant requirements for occupational exposure in planned exposure situations as stated in Section 3 shall apply.
      Exposure of aircrew and space crew due to cosmic radiation
      1. The regulatory body or other relevant authority shall determine whether assessment of the exposure of aircrew due to cosmic radiation is warranted.
      2. Where such assessment is deemed to be warranted, the regulatory body or other relevant authority shall establish a framework which shall include a reference level of dose and a methodology for the assessment and recording of doses received by aircrew from occupational exposure to cosmic radiation.
      3. In accordance with para. 5.31:
        1. Where the doses of aircrew are likely to exceed the reference level, employers of aircrew:
          1. Shall assess and keep records of doses;
          2. Shall make records of doses available to aircrew.
        2. Employers:
          1. Shall inform female aircrew of the risk to the embryo or fetus due to exposure to cosmic radiation and of the need for early notification of pregnancy;
          2. Shall apply the requirements of para. 3.114 in respect of notification of pregnancy.
      4. The regulatory body or other relevant authority shall establish, where appropriate, a framework for radiation protection that applies to individuals in space based activities that is appropriate for the exceptional conditions of space. While the requirements of these Standards in respect of dose limits do not apply to individuals in space based activities, all reasonable efforts shall be made to optimize protection for individuals in space based activities by restricting the doses received by such individuals while not unduly limiting the extent of such activities.