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2.16. 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.

2.17. The government shall ensure that the regulatory body has the legal

authority, competence and resources necessary to fulfil its statutory functions and

responsibilities.

2.18. 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.

2.19. The government shall establish mechanisms to ensure that:

(a) 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;

(b) Interested parties are involved as appropriate in regulatory decision making

processes or regulatory decision aiding processes.

2.20. 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.

2.21. The government shall ensure that requirements are established for:

(a) Education, training, qualification and competence in protection and safety

of all persons engaged in activities relevant to protection and safety;

(b) The formal recognition12 of qualified experts;

protection and safety.

12 ‘Formal recognition’ means documented acknowledgement by the relevant authority

that a person has the qualifications and expertise required for the responsibilities that he or she

will bear in the conduct of the authorized activity.

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2.22. 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.

2.23. 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.

2.24. 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.

2.25. 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.

2.26. 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.

2.27. The government shall ensure that infrastructural arrangements are in place

for the interfaces between safety and the security of radioactive sources.

2.28. In establishing the legal and regulatory framework for protection and

safety, the government:

(a) Shall fulfil its respective international obligations;

(b) Shall allow for participation in relevant international arrangements,

including international peer reviews;

13 Additional measures are taken for security in the transport of radioactive material. The

IAEA issues guidance on security in the transport of radioactive material in the IAEA Nuclear

Security Series of publications.

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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.

2.29. 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.

2.30. The regulatory body shall establish a regulatory system for protection and

safety that includes [8]:

(a) Notification and authorization;

(b) Review and assessment of facilities and activities;

(d) Enforcement of regulatory requirements;

(e) The regulatory functions relevant to emergency exposure situations and

existing exposure situations;

(f) Provision of information to, and consultation with, parties affected by its

decisions and, as appropriate, the public and other interested parties.

2.31. 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.

2.32. 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.

2.33. 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.

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2.34. 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.

2.35. 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 generators

;

— 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.

2.36. 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.

2.37. 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.

2.38. 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.

14 The regulatory body specifies which sources are to be included in the registers and

inventories, with due consideration given to the associated risks.

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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.

2.39. 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.

2.40. The principal parties responsible for protection and safety are:

(a) Registrants or licensees, or the person or organization responsible for

facilities and activities for which notification only is required;

(b) Employers, in relation to occupational exposure;

(d) Those persons or organizations designated to deal with emergency exposure

situations or existing exposure situations.

2.41. Other parties shall have specified responsibilities in relation to protection

and safety. These other parties include:

(a) Suppliers of sources, providers of equipment and software, and providers

of consumer products;

(b) Radiation protection officers;

(d) Medical physicists;

(e) Medical radiation technologists;

(f) Qualified experts or any other party to whom a principal party has assigned

specific responsibilities;

(g) Workers other than workers listed in (a)–(f) in this paragraph;

(h) Ethics committees.

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2.42. 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:

(a) Shall adopt objectives for protection and safety in accordance with the

requirements of these Standards;

(b) 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.

2.43. The relevant principal parties shall ensure that, in the implementation of the

protection and safety programme:

(a) The measures and resources that are necessary for achieving the objectives

for protection and safety have been determined and are duly provided;

(b) The programme is periodically reviewed to assess its effectiveness and its

continued fitness for purpose;

corrected, and steps are taken to prevent their recurrence;

(d) Arrangements are made to consult with interested parties;

(e) Appropriate records are maintained.

2.44. 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.

2.45. 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.

2.46. The relevant principal parties shall ensure that qualified experts are

identified and are consulted as necessary on the proper observance of these

Standards.

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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

2.47. The principal parties shall demonstrate commitment to protection and safety

at the highest levels within the organizations for which they are responsible.

2.48. The principal parties shall ensure that the management system

is designed

and applied to enhance protection and safety by:

(a) Applying the requirements for protection and safety coherently with other

requirements, including requirements for operational performance, and

coherently with guidelines for security;

(b) Describing the planned and systematic actions necessary to provide

adequate confidence that the requirements for protection and safety are

fulfilled;

requirements;

(d) Providing for the regular assessment of performance for protection and

safety, and the application of lessons learned from experience;

(e) Promoting safety culture.

2.49. 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.

2.50. The principal parties shall be able to demonstrate the effective fulfilment of

the requirements for protection and safety in the management system.

15 Requirements on the management system for facilities and activities are established in

Ref. [13].

Safety culture

2.51. The principal parties shall promote and maintain safety culture by:

(a) Promoting individual and collective commitment to protection and safety at

all levels of the organization;

(b) Ensuring a common understanding of the key aspects of safety culture

within the organization;

teams in carrying out their tasks safely and successfully, with account taken

of the interactions between individuals, technology and the organization;

(d) 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;

(e) Ensuring accountability of the organization and of individuals at all levels

for protection and safety;

(f) Encouraging open communication with regard to protection and safety

within the organization and with relevant parties, as appropriate;

(g) Encouraging a questioning and learning attitude, and discouraging

complacency, with regard to protection and safety;

(h) Providing means by which the organization continually seeks to develop

and strengthen its safety culture.

Human factors

2.52. 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:

(a) 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.

(b) Appropriate equipment, safety systems and procedural requirements are

provided, and other necessary provision is made:

(i) 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;

(ii) To provide means for detecting human errors and for correcting them

or compensating for them;

(iii) 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

3.1. The requirements for planned exposure situations apply to the following

practices:

(a) 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;

(b) The production and supply of devices that generate radiation, including

linear accelerators, cyclotrons, and fixed and mobile radiography

equipment;

fuel cycle that involve or that could involve exposure to radiation or

exposure due to radioactive material;

(d) 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;

(e) 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;

(f) The mining and processing of raw materials that involve exposure due to

radioactive material;

(g) Any other practice as specified by the regulatory body.

3.2. The requirements for planned exposure situations apply to exposure due to

sources within practices

, as follows:

(a) 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;

(b) 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.

3.3. 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.

3.4. 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:

(a) Exposure due to material

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

K is greater than 10 Bq/g;

(b) Public exposure due to discharges or due to the management of radioactive

waste arising from a practice involving material as specified in (a) above;

16 For example, a sterilization gamma irradiation unit is a source for the practice of

radiation preservation of food. An X ray unit may be a source for the practice of radiodiagnosis.

A nuclear power plant is part of the practice of generating electricity by nuclear fission,

and may be regarded as a single source (e.g. with respect to discharges) or as a collection

of sources (e.g. for purposes of occupational radiation protection). A complex or multiple

installation situated at one location or site may, as appropriate, be considered a single source for

the purposes of application of these Standards.

17 A situation of exposure due to radionuclides of natural origin in food, feed, drinking

water, agricultural fertilizer and soil amendments, construction materials and residual

radioactive material in the environment is treated as an existing exposure situation regardless

of the activity concentrations of the radionuclides concerned.

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