GENERAL REQUIREMENTS FOR PROTECTION AND SAFETY

• DEFINITIONS
  
  1. Terms used have the meanings given under Definitions.
• INTERPRETATION
  
  2. 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
  
  3. 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.
  4. 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.
  5. 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
  
  6. These Standards shall enter into force one year after the date of their adoption or acknowledgement, as appropriate, by the Sponsoring Organization.
  7. 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.

  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. 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.
  16. 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.
  17. The government shall ensure that the regulatory body has the legal authority, competence and resources necessary to fulfil its statutory functions and responsibilities.
  18. 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.
  19. 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.
  20. 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.
  21. 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.
  22. 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.
  23. 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.
  24. 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.
  25. 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
  26. 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.
  27. The government shall ensure that infrastructural arrangements are in place for the interfaces between safety and the security of radioactive sources.
  28. 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.
  29. 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.
  30. 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.
  31. 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.
  32. 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.
  33. 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.
  34. 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.
  35. 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.
  36. 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.
  37. 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.
  38. 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.
  39. 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.
  40. 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.
  41. 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.
  42. 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.
  43. 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.
  44. 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.
  45. 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.
  46. 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
    
    47. The principal parties shall demonstrate commitment to protection and safety at the highest levels within the organizations for which they are responsible.
    48. 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.
    49. 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.
    50. The principal parties shall be able to demonstrate the effective fulfilment of the requirements for protection and safety in the management system.
  • Safety culture
    
    51. 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
    
    52. 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.