ST. KITTS & NEVIS:

RADIATION SAFETY AND SECURITY REGULATIONS, 2024

ARRANGEMENT OF REGULATIONS

PART I

Preliminary

Citation.
Interpretation.
Application of Regulations.

PART II

Application for a Licence to undertake a practice
Notification and application for licence.
Confidential information.

PART III
General Responsibilities and Duties of The Licensee
Licensee to carry out activities described in the license.
General responsibilities of licensee regarding protection and safety.
Breach of safety requirements.
Modification of practice or source.
Notification of emergency exposure situations.
Reports.

PART IV
Requirement for Radiation Safety
Justification of sources.
Management requirements.
Human factors.
Radiation Protection Officers and Qualified Experts.
Dose constraints.
Dose limits.

PART V

Verification of safety
Safety assessment.
Documentation of safety assessment.
Additional reviews of safety assessment.
Monitoring, Testing and Verification of Compliance.
Inventory and Records.
Information for sealed sources.

PART VI

Human imaging for purposes other than medical diagnosis, medical treatment or biomedical research
Justification of practices of any type of human imaging using radiation.
Optimization of protection and safety.
Procedures with inspection imaging devices.

PART VII OCCUPATIONAL EXPOSURE
General Responsibility of licensees in occupational exposure situations.
Duty of licensee in occupational exposure.
Cooperation between Employers and Licensees.
Classification of areas.
Supervised areas.
Local Rules and Procedures and Personal Protective Equipment.
Guidelines.
Licensee responsibility to provide protective equipment.
Monitoring of workplace.
Occupational Exposure Assessment.
Records of occupational Exposure.
Access to records.
Retention of workers.
Workers’ Health Surveillance.
Information, Instructions and Training.
Condition of service.
Special Arrangements for female workers and for persons under 18 years of age undergoing training.

PART VIII

Medical exposure
General Responsibilities of Licensees in medical exposure.
Justification of Medical Exposure.
Optimization of Protection for Medical Exposures
Operational considerations.
Optimization.
Calibration.
Dosimetry of patients.
Diagnostic Reference Levels.
Quality Assurance for Medical Exposure.
Dose Constraints.
Pregnant or breast-feeding female patients.
Release of Patients after Radionuclide Therapy.
Unintended and Accidental Medical Exposures.
Investigation of Unintended and Accidental Medical Exposures.
Records Related to Medical Exposures.

PART IX

Public exposure
General responsibilities.
Control of visitors.
Sources of External Irradiation.
Contamination in Areas Accessible to Members of the Public.
Monitoring of Public Exposure.
Consumer products.

PART X

Radiation generators and radioactive sources
General responsibilities.
Design of Radiation Generators and Radioactive Sources.
Supply and Procurement of Radioactive Sources.

PART XI

Import and export of radioactive sources
Export of Radioactive Sources.
Import of Radioactive Sources.

PART XII

Management of Radioactive Waste
General Responsibilities in respect of radioactive waste.
License Application for radioactive waste.
Management system for radioactive waste.
Radioactive Waste Management Officers.
Radioactive waste records and reports.
Emergency preparedness.
Security.
Nuclear safeguards.
Control of radioactive waste generation.
Radioactive waste characterization and classification.
Acceptance criteria for radioactive waste.
Conditioning.
Storage of radioactive waste.
Storage of radioactive waste.
Radiation source inventory.
Recycling and reuse.
Discharge of radioactive materials into the environment.
Clearance and control of entrance.
General Licensee Responsibility in relation to radioactive waste.

Part ???
Development and operation of waste management facilities
Location and design of radioactive waste management

Part ??? facilities.
Construction and commissioning of radioactive waste management facilities.

PART VI.

Decommissioning of Facilities and Activities
Decommissioning facility..

PART VIII.

Emergency Preparedness and Response
Emergency plan.
Protective actions or remedial actions.
Protection of emergency workers in emergency exposure situations.
transportation.

part xiii Offence and Penalties
Suspension, revocation or modification.
Breach of regulations.
General penalty.

Part xiv Miscellaneous
transitional.
Compliance with other laws.
Commencement. Schedule I.

Schedule II.

Schedule III.

ST. KITTS & NEVIS

STATUTORY INSTRUMENT NO. OF 2023

REGULATIONS made by the St. Kitts & Nevis Bureau, with the approval of the Minister responsible for Trade, in exercise of the powers conferred upon them by section 41 and 79 of the Radiation Safety and Security Act, of the Substantive Laws of St. Kitts & Nevis, and all other powers thereunto them enabling.

(Gazetted , 2024)

PART I

These Regulations may be cited as the

RADIATION SAFETY AND SECURITY REGULATIONS, 2023.
In these Regulations–
“Act” means the Radiation Safety and Security Act;

“disuse source” means a radioactive source that is no longer used, and is not intended to be used, for the practice for which a licence has been granted.

“dosimeter” means a device for measuring a dose of radiation that is worn or carried by an individual;
“GSR” means General Safety Requirements of the IAEA;

“notification” means a document submitted to the Bureau by the legal person to notify an intention to carry out an activity or practice.

Citation.

Interpretation.

“registration”

“IEC” means International Electrotechnical Commission “ISO” the International Organization for Standardization.

Application of Regulations.

Notification and application for licence.
Schedule I.
–(1) These Regulations apply to–
1. any authorised activity or practice or radiation source within a practice that gives rise to planned exposure situations.
2. the importation, exportation, transportation and storage of a radiation source within a practice;
3. the use of radiation or radioactive material for medical, industrial, veterinary, agricultural, legal or security purposes and the use of associated equipment, software or devices in circumstances where such use could affect exposure to radiation;
4. the use of radiation or radioactive material for education, and training, including any activity relating to such use that involves or could involve exposure to radiation or exposure due to radioactive material; and
5. any other practice specified by the Minister by order published in the Gazette, after consultation with the Bureau.
  (2) These Regulations do not apply to the following exposures–
  1. exposures from natural radioactivity in the body;
  2. cosmic radiation; and
  3. such other radiation sources that are essentially not amenable to control, as may be prescribed by the Bureau.
  PART II
  
  Application for a Licence to undertake a practice
–(1) Any person who proposes to undertake an activity or practice shall submit a notification to the Bureau of Standards of such an intention in the form prescribed in Schedule I.
1. Upon receipt of a notification under sub-regulation (1), the Bureau shall, within seven days after receipt, make a determination whether the proposed practice or activity requires a licence.
2. Where a licence is required, the Bureau shall inform the applicant to apply in writing in the prescribed form based on a graded approach.
3. An application referred to in sub-regulation (3) shall be accompanied
by–
1. the relevant fee specified in the Schedule II; and
2. all supporting documents required by the Bureau for the purpose of determining the application, including–
  1. an evaluation of the nature, likelihood and magnitude of the exposures attributed to the practice and sources within the practice;
  2. a safety assessment in accordance with GSR Part 3 requirement 13 section 3.29-3.36 of the IAEA Safety Standards;
  3. a prospective assessment made for radiological environmental impact, commensurate with the radiation risks associated with the facility or activity;
  4. an emergency plan, if applicable, in accordance with GSR Part 7 of the IAEA Safety Standards; and
  5. any other supporting documents the Bureau may request.
    (4) The Bureau may exempt practices and sources within a practice
    
    Schedule II.
    from these Regulations where the activity concentration level of the radioactive source falls within the levels for exemption listed in Schedule 1 of GSR Part 3.
–(1) An applicant may specify in an application for a licence that the applicant desires that certain information be held as confidential information by the Bureau of Standards, and such information shall clearly be so identified in the application.

(2) The Bureau shall ensure that any information considered as confidential information received in an application is filed and stored securely as necessary.

PART III

General Responsibilities and Duties of The Licensee

Confidential information.

Licensee to carry out activities described in the licence.

General responsibilities of licensee regarding protection and safety.
–(1) The Licensee shall, for the duration of the period of validity of the Licence, be deemed to have authority to carry out the activity described in the License, without the need for any further specific licence from the Bureau of Standards

(2) Notwithstanding paragraph (1), as part of the terms and conditions of the Licence, the licensee may be required to notify the Bureau prior to the international transfer of any item that is the subject of the grant of a Licence.
–(1) In respect of the activities or practices which are the subject of a licence, the licensee shall–
1. ensure compliance with these Regulations;
2. establish and implement the technical and organizational measures that are necessary to ensure protection and safety;
3. establish organizational arrangements for protection and safety and defining the accountability therefor; and
4. take all necessary steps for the protection and safety of its employees, its patients and members of the public;
5. establish radiation protection and safety objectives in conformity with these Regulations;
6. develop, implement, and keep records in respect of, a protection and safety programme commensurate with the radiation risks associated with the exposure situation of the activity or practice which is the subject of the License, and which is sufficient to ensure compliance with these Regulations, and such a programme shall include–
  1. determining and keeping continually under review the measures needed to achieve the radiation safety objectives, ensuring that the resources needed for their implementation are provided, and verifying on a regular basis that the radiation safety objectives are being achieved;
  2. identifying, preventing, and promptly correcting any failures or shortcomings in the radiation safety measures;
  3. facilitating consultation and co-operation among all parties with respect to radiation safety;
  4. keeping records regarding the discharge of the licensee responsibilities under these Regulations;
7. ensure that–
  1. radiation sources are managed in accordance with the licence;
  2. when radiation sources are not in use, they are promptly stored;
  3. a radiation generator or radiation source is transferred only if the recipient possesses the necessary licence;
  4. arrangements are made for the safe management of the radiation sources including financial provisions where appropriate once they have become disused;
  5. radiation sources are imported and exported in accordance with these Regulations;
  6. radiation sources are shipped and received in accordance with the regulations; and
  7. such assistance is provided to local authorities in recovering any lost or stolen source;
8. ensure that arrangements for protection and safety are reviewed periodically and updated as necessary;
9. establish procedures for reporting on, and learning from, accidents and other incidents;
10. prevent reasonably foreseeable accidents in the facility or the or practice by;
  1. mitigating the consequences of those accidents that do occur;
  2. providing radiation workers with the information, instructions, training and equipment necessary to restrict potential exposures;
    
    (iv) ensuring that there are adequate procedures for the control of the facility and for the management of any reasonably foreseeable accidents;
11. ensure that maintenance, inspection, and testing appropriate to the preservation of the protection and safety measures are able to be carried out and are carried out, without undue occupational exposure;
12. ensure that all relevant safety documentation is available;
13. ensure that levels of public exposure are continuously monitored;
  
  Breach of safety requirements.
  
  Modification of practice or source.
14. 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; and
  
  (m) ensure that any delegation of responsibilities by a principal party is documented.
  1. The licensee may designate suitably qualified person to carry out actions and task related to these responsibilities,
    
    Provided that the licensee shall retain the prime responsibility for protection and safety.
  2. A licensee shall provide to the Bureau any information regarding the licensee’s employees that the Bureau may reasonably require for the purposes of this regulation.
–(1) Where a breach of the radiation safety requirements is committed in respect of any source or activity that is the subject of an licence, the licensee shall, within twenty-four hours of becoming aware of the breach–
1. investigate the breach and its causes, circumstances and consequences;
2. report any corrective or preventative actions taken or to be taken to remedy the breach and prevent a reoccurrence;
3. report its findings under paragraph (a) to the Bureau of Standards; and
4. take any other action that may be required under these Regulations, or as directed by the Bureau of Standards, in respect of the breach.
  1. A licensee who–
    1. fails to take any corrective or preventive actions to any breach; and
    2. fails to report any breach or corrective or preventive actions taken or to be taken within a reasonable time in accordance with these Regulations
      commits an offence.
A licensee shall–
1. notify the Bureau of the licensee’s intention to introduce modifications to any practice or source which is the subject of the licence, if the modification could have significant implications for protection and safety; and
2. refrain from carrying out any such modification without the approval of the Bureau.
–In respect of the practice or source which is the subject of a licence, the licensee shall notify the Bureau–
1. immediately, of any event in which a dose limit is exceeded;
2. not later than twenty-four hours after discovery of any significant unintended or accidental medical exposure situation;
3. as soon as is reasonably practicable, of any lost sources and any theft or attempted theft of sources;
4. immediately, of any discharges of radioactive waste exceeding the limits specified in the licence;
5. immediately, of any unusual events or incidents such as–
  1. loss of control over a radiation source;
  2. unauthorized use of any source; or
  3. discovery of an orphan source.
    
    (2) A notification under this regulation shall be in such manner as shall be determined by the Bureau and may include use of telephone, facsimile, electronic mail or any other means the Bureau considers appropriate.
A licensee shall provide the Bureau with the following written reports in respect of the licensee’s sources, facilities, activities and practices–
1. within thirty days after becoming aware of a significant medical exposure that is accidental, a report stating the cause of the exposure and the doses incurred, the corrective measures taken, and any other relevant information with respect thereto;
2. a report as to all authorized discharges of radioactive waste into the environment, within thirty days of the discharge;
3. a detailed written report on the release of radioactive material to the environment, within thirty days after the release;
  
  Notification of exceeded dose limits to the Bureau.
  
  Reports.
4. a report of its radiation source inventory data, showing any changes to those data, except for routine movements of the source allowed in the licence;
5. at such intervals as may be specified by the Bureau from time to time, a report on the licence holder’s radioactive waste management activities.
  
  Justification of sources.
  PART IV
  
  Requirements for Radiation Protection
–(1) The Bureau shall ensure that all activates and practices or sources within a practice are justified.
1. The practices referred to in subsection (1) include, but are not limited to–
  1. Practices, except for justified practices involving medical exposure, that result in an increase in activity, by the deliberate addition of radioactive substances or by activation, 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 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 activation;
  3. Human imaging using radiation that is performed as a form of art or for publicity purposes.
  4. Human imaging using radiation that is performed for occupational, legal or health insurance purposes, and is undertaken without reference to clinical indication;
  5. Human imaging using radiation for theft detection purposes;
  6. Human imaging using radiation for the detection of concealed objects for anti-smuggling purposes;
  7. Human imaging using radiation for the detection of concealed objects that can be used for criminal acts or to pose a national security threat;
2. If, in exceptional circumstances, the Bureau decides that the justification of such human imaging is to be considered under regulation (2)(d)(f) and (g), requirements 34 and 35 of GSR part 3 shall apply.
–(1) A licensee shall establish a management system, commensurate with the size and nature of the authorized activity, which ensures that–
1. Policies and procedures are established that identify safety as being of the highest priority;
2. Problems affecting protection and safety are promptly identified and corrected in a manner commensurate with their importance;
3. The responsibilities of each individual for safety are clearly identified and each individual is suitably trained and qualified;
4. Clear lines of authority for decisions on safety are defined;
5. Organizational arrangements and lines of communications are established that result in an appropriate flow of information on safety at and between the various levels in the entire organization of the licensee.
6. That the confidentiality of information that it receives in confidence from another party is protected; and
7. That information received in confidence from another party is only provided to a third party with the consent of the first party.
  
  (2) The licensee shall ensure that the protection and safety elements of the management system are commensurate with the complexity of and the radiation risks associated with the activity.
The licensee and other parties having specified responsibilities in relation to protection and safety shall take into account human factors and shall support good performance and good practices to prevent human and organizational failures, by ensuring that–
1. equipment designed with sound ergonomic principles and its operating procedures are used, so as to–
  1. facilitate the safe operation and use of equipment;
  2. minimize the possibility that operator errors will lead to accidents; and
  3. reduce the possibility that indications of normal conditions and abnormal conditions will be misinterpreted.
    Management requirements.
    
    Human factors.
    
    Radiation Protection Officers and Qualified Experts.
    
    Dose constraints.
2. equipment, safety systems and procedural requirements are provided and other necessary provisions are made to–
  1. reduce, as far as practicable, the possibility that human error or inadvertent action could give rise to accidents or other incidents leading to the exposure of any person;
  2. provide means for detecting human errors and for correcting them or compensating for them; and
  3. facilitate protective actions and corrective actions in the event of failures of safety systems or failures of measures for protection and safety.
–(1) A licensee shall arrange for qualified experts to be identified and made available for providing advice on the observance of these Regulations when so required by the Bureau.
1. The qualifications of qualified experts in radiation safety shall include a level of academic knowledge and of professional experience compatible with the levels of risks associated with the authorized practices or sources within a practice.
2. A radiation protection officer shall be technically competent in radiation protection matters relevant to a given type of practice. The radiation protection officer oversees the application of the requirements of these Regulations to that practice.
3. An applicant may propose to use a radiation protection officer in place of a qualified expert in radiation safety on the basis of the relatively low risk of the practice.
4. Licensees shall keep the Bureau informed of the arrangements made with respect to sub-regulations (1) and (2),
5. The licensee shall inform all employees at least annually of the importance of effective measures for protection and safety and be trained in their implementation.
6. Training programmes shall be routinely evaluated and updated as necessary.
–(1) For occupational exposure and public exposure, a licensee shall establish relevant constraints for use in the optimization of protection and safety for any particular source within a practice to ensure that the dose limits prescribed in Schedule III are not existed.
1. In case of any source that can release radioactive material to the environment, the dose constraints shall be established so that the prospective annual doses to members of the public, including people distant from the
  
  source and people of future generations, summed over all exposure pathways, including contributions by other practices and sources, are unlikely to exceed the dose limits specified in Schedule III or any lower values established by the Bureau.
A licensee shall ensure that the exposure of individuals due to the practices authorized is restricted so that neither the effective dose nor the equivalent dose to tissues or organs exceeds any relevant dose limit specified in Schedule III.

PART V

Verification of safety
–(1) Upon request by the Bureau, the licensee shall prepare safety assessments that are either generic or specific to the practices or sources for which they are responsible so as to–
1. 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. determine the expected magnitudes and likelihood of exposures in normal operation and, to the extent reasonable and practicable, make an assessment of potential exposures; and
3. assess the adequacy of the provisions for protection and safety.
  (2) The safety assessment shall include a systematic critical review
  
  Dose limits.
  
  Safety Assessment.
  of–
  1. The 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 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 exposure.
Licensees shall ensure that the safety assessment is documented and that it is independently reviewed under the relevant management system.
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.
Licensees and employers shall ensure that–
1. Monitoring and measurements of parameters are performed as necessary for verification of compliance with the requirements of regulations and licence conditions;
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 Bureau, including records of the tests and calibrations carried out in accordance with regulations and licence conditions; and
5. The results of monitoring and verification of compliance are shared with the Bureau as required.
Licensees shall establish, maintain and be able to retrieve records relating to–
1. Inventory of sealed sources and radiation generators;
2. Records of doses from occupational exposures;
3. Records relating to facilities and activities;
4. Inventory of radioactive waste;
5. Records of events, including non-routine release of radioactive material to the environment;
6. Records that might be necessary for decommissioning or closure of facilities;
7. The transfer of radioactive sources; and
8. The testing of instruments and safety systems, and calibrations carried out in accordance with the requirements of the Regulations.
–(1) Individual sealed source records shall include the–
1. Location of the source;
2. Radionuclide;
  
  Monitoring, Testing and Verification of Compliance.
  
  Inventory and Records.
3. Radioactivity on a specified date;
4. Serial number or unique identifier;
5. Chemical and physical form;
6. Source use history, including recording all movements into and out of the storage location;
7. Receipt, transfer or disposal of the source;
8. Other information to enable the source to be identifiable and traceable.
  1. A licensee shall conduct regular inventory checks to confirm that radiation sources are in their assigned locations and are under control.
  2. A licensee shall provide the Bureau as required with information from their inventory records of radiation generators and radioactive sources.
  Justification of practices of any type of human imaging using radiation.
  PART VI
  
  Human imaging for purposes other than medical diagnosis, medical treatment or biomedical research
–(1) The justification process applied to the practice of any type of human imaging procedure in which radiation is used for purposes other than for medical diagnosis or medical treatment or as part of a programme of biomedical research 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 through the process specified in (1) that a particular practice of human imaging using radiation is justified, then, such a practice shall be subject to regulatory control.
For human imaging using radiation conducted by medical personnel using medical radiological equipment, which exposes humans to radiation for employment related, legal or health insurance4 purposes without reference to clinical indications, the licensee shall ensure that the appropriate optimization requirements for medical exposure in accordance with regulation 49 of these Regulations are applied, with dose constraints used instead of diagnostic reference levels.
–(1) 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 in accordance with regulations 12 to 16.
1. A licensee 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.
2. The 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 (IEC) or the International Organization for Standardization (ISO) or to equivalent national standards.
PART VII

Occupational exposure
For workers who are engaged in activities in which they are or could be subject to occupational exposure in planned exposure situations, licensees shall be responsible for–
1. protection of workers against occupational exposure; and
2. compliance with relevant requirements of regulations and licence conditions.
–(1) A licensee shall ensure, for all workers engaged in activities in which they are or could be subject to occupational exposure, that–
1. occupational exposures is controlled so that the relevant dose limits for occupational exposure specified in annex ii are not exceeded;
2. protection and safety is optimized in accordance with regulations 24 and 25;
3. decisions with regard to measures for protection and safety are recorded and made available to relevant parties, through their representatives, as specified by the Bureau;
  
  Optimization of protection and safety.
  
  Procedures with inspection imaging devices.
  
  General Responsibility of licensees in occupational exposure situations.
  
  Duty of licensee in occupational exposure.
4. policies, procedures and organizational arrangements for occupational protection and safety are established to implement the relevant requirements of these regulations, 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 the occupational exposure;
6. necessary workers’ health surveillance and health services for workers are provided;
7. monitoring equipment and personal protective equipment are 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 regulations and licence conditions;
10. arrangements are made to facilitate consultation and cooperation with workers, with regard to protection and safety, through their representatives where appropriate, on all measures to achieve effective application of these regulations;
11. necessary conditions for promoting a safety culture are provided.
  1. Licensees and employers shall–
    1. Involve workers, through their representatives where appropriate, in optimization of protection and safety; and
    2. Establish and use, as appropriate, constraints as part of optimization of protection and safety.
    3. 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.(
    4. Licensees and employers 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
      
      Cooperation between Employers and Licensees
      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.
    5. record any report received from a worker that identifies any circumstances that could affect safety conditions or compliance with the requirements of these Regulations and shall take appropriate remedial actions;
    6. facilitate compliance by workers with the requirements of these Regulations.
–(1) Employers and licensees shall cooperate to the extent necessary for compliance by all responsible parties with the requirements of the Regulations.
1. Cooperation between the employer and the licensee shall include–
  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 licensee;
  2. Specific assessments of the doses received by workers as specified in (a);
  3. A clear allocation and documentation of the responsibilities of the employer and those of the licensee for protection and safety.
1. As part of the cooperation between parties, the licensee responsible for the source or for the exposure shall–
  1. obtain from the employers, including self-employed individuals, the previous occupational exposure history of workers as specified in regulation 48, and any other necessary information;
  2. provide appropriate information to the employer, including any available information relevant for compliance with the requirements of these standards that the employer requests;
  3. provide both the worker and the employer with the relevant exposure records
Licensees shall designate controlled areas in which specific measures for protection and safety shall be required in order to–

Classification of Areas.
1. control exposures or preventing the spread of contamination in normal operations;
2. prevent or limit the likelihood and magnitude of exposures in anticipated operational occurrences and accident conditions.
1. Licensees shall–
  1. determine the boundaries of any controlled area on the basis of the likelihood and magnitude of expected exposures and the type and extent of the procedures required for protection and safety;
  2. delineate controlled areas by physical means or, where this is not reasonably practicable, by some other suitable means;
  3. where a source is only intermittently brought into operation or energized or is moved from place to place, delineate an appropriate controlled area by means that are appropriate under the prevailing circumstances and specify exposure times;
  4. display a warning symbol, recommended by the ISOA, and display instructions at access points to and at appropriate locations within controlled areas;
  5. establish measures for occupational protection and safety, including, as appropriate, physical measures to control the spread of contamination and local rules and procedures for controlled areas;
  6. restrict access to controlled areas by means of administrative procedures, such as the use of work permits, and by physical barriers, which could include locks or interlocks; the degree of restriction being commensurate with the likelihood and magnitude of exposures;
  7. provide, as appropriate, at entrances to controlled areas–
    1. personal protective equipment;
    2. equipment for individual monitoring and workplace monitoring;
    3. suitable storage for personal clothing;
  8. provide, as appropriate, at exits from controlled areas–
    1. equipment for monitoring for contamination of skin and clothing;
    2. equipment for monitoring for contamination of any objects or material being removed from the area;
    3. washing or showering facilities and other personal decontamination facilities;
    4. suitable storage for contaminated personal protective equipment;
  9. periodically review conditions to assess whether there is any need to modify the measures for protection and safety or the boundaries of controlled areas; and
2. provide appropriate information, instruction and training for persons working in controlled areas.
–(1) Licensees shall designate as a supervised area, any area not already designated as a controlled area, but where occupational exposure conditions need to be kept under review even though specific protection measures and safety provisions are not normally needed.
1. Licensees, taking into account the nature, likelihood and magnitude of exposures or contamination in the supervised areas, shall–
  1. delineate the supervised areas by appropriate means;
  2. display approved signs at access points to supervised areas; and
  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.
Employers 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–
1. Engineered controls;
2. Administrative controls; and
3. Personal protective equipment.
–(1) Licensees and employers shall establish in writing guidlines and procedures that are necessary for protection and safety for workers and other persons;

Supervised areas.

Local Rules and Procedures and Personal Protective Equipment

…

Guidelines.

Licensee responsibility to provide protective equipment.

Monitoring of Workplace
(2) Nothing in these Regulations shall is construed as relieving employees and licensees from complying with any other law governing hazards in the work place.
Licensees and employers shall ensure that–
1. if necessary, workers are provided with suitable and adequate personal protective equipment that meets relevant standards or specifications, including–
  1. protective clothing;
  2. respiratory protective equipment the characteristics of which are known to the users; and
  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; and
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.
–(1) Licensees, in cooperation with employers, shall establish, maintain and keep under review a programme for the monitoring at the workplace under the supervision of a radiation protection officer or qualified expert, commensurate with the graded approach.
1. The type and frequency of monitoring of workplaces shall–
  1. be sufficient to enable–
    1. Evaluation of the radiological conditions in all workplaces;
    2. Assessment of the exposure of workers in controlled areas and supervised areas; and
    3. Review of the classification of controlled and supervised areas; and
  2. 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.
1. Licensees, in cooperation with employers, 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.
2. The programmes for monitoring of the workplace shall specify–
  1. the quantities to be measured;
  2. where and when the measurements are to be made and at what frequency;
  3. the most appropriate measurement methods and procedures;
  4. investigation levels and the actions to be taken if they are exceeded.
–(1) Licensees and employers shall be responsible for making arrangements for the assessment of the occupational exposure of workers, on the basis of individual monitoring where appropriate, and shall ensure that arrangements are made with an approved dosimetry service providers that operate under a quality management system.
1. 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.
2. 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 of individual monitoring, as appropriate.
–(1) Employers and licensees shall maintain records of occupational exposure for each worker for whom assessment of occupational exposure is required under regulation 41.
1. Records of occupational exposure for each worker shall be maintained during and after the worker’s working life, at least until the 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.
2. Records of occupational exposure shall include–
Occupational Exposure Assessment.

Records of occupational Exposure.

Access to records.

Retention of workers.

Workers’ Health Surveillance.
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 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; and
4. Records of any assessment of doses, exposures and intakes due to actions taken in an emergency or due to accidents or other incidents, which shall be distinguished from doses, exposures and intakes due to normal conditions of work and which shall include references to reports of any relevant investigations.
Employers and licensees shall–
1. Provide workers with access to records of their own occupational exposure;
2. Provide the supervisor of the programme for workers’ health surveillance, the Bureau and the relevant employer with access to workers’ records of occupational exposure;
3. Facilitate the provision of copies of workers’ exposure records to new employers when workers change employment;
4. Make arrangements for the retention of exposure records for former workers by the employer or licensee;
5. In complying with paragraphs (a) to (d), give due care and attention to maintaining the confidentiality of records.
If a licensee ceases 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 Bureau or by relevant employer or licensee in accordance with regulation 37.
–(1) Licensees shall make arrangements for health surveillance based on the general principles of occupational health and 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 licensee responsible for the source shall, as a

precondition for the engagement of such workers, make special arrangements for workers’ health surveillance in accordance with these Regulations.
Licensees shall–
1. 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. 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; and
3. maintain records of the training provided to individual workers.
–(1) As a condition of service, special compensatory arrangements or preferential consideration with respect to salary, special insurance coverage, working hours, length of vacation, additional holidays or retirement benefits shall not be used as substitutes for measures for protection and safety in accordance with the requirements of these Regulations.

(2) Licensees shall make all reasonable efforts to provide workers with suitable alternative employment in circumstances for which it has been determined, either by the Bureau or in the framework of the programme for workers’ health surveillance in accordance with the requirements of these Regulations, that workers, for health reasons, may no longer continue in employment in which they are or could be subject to occupational exposure.
–(1) Licensees shall inform female workers who are liable to enter controlled areas, supervised areas or who may undertake emergency duties with appropriate information of–
1. the risk to an embryo or fetus due to exposure of a pregnant woman;
2. the importance of a female worker notifying her employer as soon as possible if she suspects that she is pregnant or if she is breast-feeding;
3. the risk of health effects for a breast-fed infant due to ingestion of radioactive substances.
  1. 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 a female worker from work.
    
    Information, Instructions and Training
    
    Conditions of Service
    
    Special Arrangements for female workers and for persons under 18 years of age undergoing training
  2. 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 infant is afforded the same level of protection as is required for members of the public.
  3. Employers and licensees shall ensure that no person under the age of 16 years is or could be subject to occupational exposure.
  4. Employers 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.
  PART VIII
  
  General Responsibilities of Licensees in medical exposure.
  Medical exposure
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 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. 4(a) of this article;
4. the patient or the patient’s legal authorized representative has been informed of the expected diagnostic or therapeutic benefits of the radiological procedure as well as the radiation risks.
  1. 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 the Bureau and a radiological medical practitioner has assumed responsibility as specified in para. 4(a) of this regulation.
  2. 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.
  3. 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 article 48 and the optimization of protection and safety, in cooperation with the medical physicist and the medical radiation technologist;
    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. medical personnel and paramedical personnel are specialized in the appropriate area and meet the respective requirements for education, training and competence in radiation protection as specified by the Bureau;
    5. the names of all medical and paramedical personnel are named in a list maintained up-to-date;
    6. for therapeutic radiological procedures, the requirements of these regulations for calibration, dosimetry and quality assurance, including the acceptance and commissioning of medical radiological equipment, as specified in articles 50, 51(c), 53(1) and 52(2), are conducted by or under the supervision of a medical physicist;
    7. 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 articles 50, 51(a), 51(b), 52, 53(1) and 53(2), 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; and
    8. any delegation of responsibilities by a principal party is documented.
  Justification of Medical Exposure
–(1) Medical exposures shall be justified by weighing the diagnostic or therapeutic benefits 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.
1. 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, with account taken, in particular for patients who are pregnant, breast-feeding or paediatric, having regard to–
  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.
2. 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.
3. 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.
4. 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 the Bureau.
5. As part of this process, the individual shall be informed in advance of the expected benefits, risks and limitations of the radiological procedure.
6. The 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 World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects and follows the guidelines for its application prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the WHO, International Ethical Guidelines for Biomedical Research Involving Human Subjects; and
  2. It is subject to approval by the Bureau, subject to the dose constraints prescribed in schedule IV.
–(1) Licensees and radiological medical practitioners shall ensure that protection and safety is optimized for each medical exposure.

(2) 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 conforms to the applicable standards of the International Electrotechnical Commission and the International Organization for Standardization.
–(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 with the radiopharmacist or radiochemist, shall ensure that the following are used–

schedule IV.

Optimization of Protection for Medical Exposures
Design considerations

Operational considerations
1. medical radiological equipment and software and, for nuclear medicine, appropriate radiopharmaceuticals; and
2. 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 the Bureau of Standards and of relevant diagnostic reference levels established in accordance with regulation 52.
  1. 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.
  2. 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 of interest, while the radioactivity in the rest of the body is kept as low as reasonably achievable.
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 a health screening programme;
  
  Optimization.
  
  Calibration.
  
  Dosimetry of Patients.
3. Volunteers subject to medical exposure as part of a programme of biomedical research;
4. Relatively high doses 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 breast-fed infant as a result of a female patient having undergone a radiological procedure with radiopharmaceuticals.
In accordance with regulations 47(4) (f) and (g), 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 Bureau of Standards;
3. calibrations of radiotherapy units are subject to independent verification 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.
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. diagnostic radiological procedures, typical doses to patients for common procedures;
2. image guided interventional procedures, typical doses to patients;
3. 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; and
4. therapeutic radiological procedures with unsealed sources, typical absorbed doses to patients.
Licensees shall ensure that–
1. local assessments, on the basis of the measurements required in Article 51, are made at approved intervals for those radiological procedures for which diagnostic reference levels have been established by Bureau;
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.
–(1) Licensees 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.
1. Licensees shall ensure that programmes of quality assurance for medical exposures 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; and
    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) are outside established tolerance limits;
    
    Diagnostic Reference Levels.
    
    Quality Assurance for Medical Exposure.
    
    Dose Constraints.
    
    Pregnant or breast-feeding female patients.
  3. verification of the appropriate physical and clinical factors used in radiological procedures;
  4. maintaining records of relevant procedures and results; and
  5. periodic checks of the calibration and conditions of operation of dosimetry equipment and monitoring equipment.
2. 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.
–(1) Licensees shall ensure that relevant dose constraints are used in the optimization of protection and safety in any radiological procedure in which an individual acts as a carer or comforter.

(2) Licensees shall ensure that dose constraints prescribed by the Bureau has been assigned functions, on a case by case basis as part of a proposal for biomedical research in accordance with regulation 48(6) is used in the optimization of protection and safety for persons subject to exposure as part of a programme of biomedical research.
Licensees shall ensure that–
1. there are arrangements in place for appropriate radiation protection in cases where a female patient is or might be pregnant or is breast-feeding;
2. 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 appropriate, 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;
3. 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 and in the optimization of protection and safety;
4. 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 breast-fed infant, so that this information can be considered in the justification for the radiological procedure and in the optimization of protection and safety.
–(1) Licensees shall ensure that there are arrangements in place to ensure 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 sealed sources or unsealed sources 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 Bureau, through consultation between the health authority professional bodies;
  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.
Licensees, in accordance with the requirements under regulations 18(11), 18(12), 27, 67(2) and 99, 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.
–(1) Licensees shall promptly investigate any of the following unintended or accidental medical exposure–
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;
  
  Release of Patients after Radionuclide Therapy.
  
  Unintended and Accidental Medical Exposures.
  
  Investigation of Unintended and Accidental Medical Exposures.
  
  Records Related to Medical Exposures.
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; and
6. any failure of medical radiological equipment, failure of software or system failure, 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.
  1. Licensees shall, with regard to any unintended or accidental medical exposures investigated–
    1. calculate or estimate the doses received and the dose distribution within the patient;
    2. indicate the corrective actions required to prevent recurrence of such an unintended or accidental 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 Bureau of Standards, a written record that states the cause of the unintended or accidental medical exposure and includes the information specified in paragraphs (a) to (c), and any other information as required by the Bureau; and for significant unintended or accidental medical exposures or as otherwise required by the Bureau, submit this written record, as soon as possible, to the Bureau;
    5. Ensure that the 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.
–(1) Licensees shall maintain for a period as specified by the Bureau and shall make available, as required, the following personnel records–
1. Records of any delegation of responsibilities by principal parties (as required in regulation 47(4)(h);
2. Records of training of personnel in radiation protection.
  1. Licensees shall maintain for a period as specified by the Bureau 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 Article 51;
    3. records of local assessments and reviews made with regard to diagnostic reference levels, as required in Article 52;
    4. records associated with the quality assurance programme, as required in Article 53(2d).
  2. Licensees shall maintain for a period as specified by the Bureau 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 Article 58(2d).
  General Responsibilities.
  PART IX
  
  Public exposure
–(1) Licensees in cooperation with suppliers and with providers of consumer products shall apply the requirements of these Regulations and shall verify and demonstrate compliance with them, as specified by the Bureau, in relation to any public exposure delivered by a source for which they have responsibility.
1. 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.
2. 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 Regulations;
  2. measures for ensuring–
    1. optimization of protection and safety;
    2. limitation of exposure of members of the public from such sources, in order that the total exposure is not
higher than the dose limits for members of the public as specified in Annex II;
Licensees, in cooperation with employers, shall–
1. apply the relevant requirements of these Regulations in respect of public exposure for visitors to a controlled area or a supervised area;
2. 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. provide adequate information and instructions to visitors before they enter a controlled area or a supervised area so as to provide protection and safety for visitors and other individuals who could be affected by their actions;
4. 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.
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, to review and approval by the Bureau prior to commissioning;
  
  Control of Visitors.
  
  Sources of External Irradiation.
  
  Contamination in Areas Accessible to Members of the Public.
  
  Monitoring of Public Exposure.
2. shielding and other measures for protection and safety, including access controls for restricting public exposure, in particular at open sites such as for some applications of industrial radiography.
Licensees shall ensure 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.
Licensees shall–
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.
2. maintain records of the results of the monitoring programmes and estimated doses to members of the public;
3. report or make available the results of the monitoring programme to the Bureau 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 made of doses to the representative person;
4. report promptly to the Bureau 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 Bureau;
5. report promptly to the Bureau 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 Bureau;
6. establish and maintain a capability to carry out monitoring in an emergency, in the event of unexpected increases in radiation levels or concentrations of radionuclides in the environment due to accidents or other unusual events attributed to the authorized source or facility;
7. verify the adequacy of the assumptions made for the assessment of public exposure and radiological environmental impacts;
8. publish or make available on request results from source monitoring and environmental monitoring programmes and assessments made of doses from public exposure.
–(1) Providers of consumer products shall ensure that such products are not made available to the public unless the justification of their use by members of the public has been approved by the Bureau and either their use has been exempted on the basis of the criteria specified in Article 16 or their provision to the public has been authorized.
1. Providers of consumer products, who import consumer products, as exempt products, for subsequent sale and distribution shall include in the application to the Bureau for authorization to distribute, a copy of the exporter’s licence issued by the relevant authority in the country of manufacture or origin which authorizes distribution to members of the public in that country.
2. Providers of consumer products, who import consumer products for sale and distribution as exempt 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 product contains radioactive substances and identifying the radionuclides and their activities;
    2. states that the provision of the product to the public has been authorized by the Bureau;
    3. provides information about required or recommended options for recycling or disposal;
  2. The information specified in (a) above is printed legibly on the retail packaging of the consumer product.
3. Providers of consumer products shall provide clear and appropriate information and instructions with each such consumer product on–
  
  Consumer Products.
  1. correct installation, use and maintenance of the product;
  2. servicing and repair;
  3. the radionuclides and their activities;
  4. dose rates in normal operation and during servicing and repair;
  5. required or recommended options for recycling or disposal.
4. Providers of consumer products shall provide the product retailers with information on safety and instructions on transport and storage.
General Responsibilities.

Design of Radiation Generators and Radioactive Sources.
PART X

Radiation generators and radioactive sources
–(1) The licensee, in cooperation with other responsible parties, shall ensure that the siting, location, design, construction, assembly, commissioning, operation, maintenance and decommissioning (or closure) of facilities or parts thereof are based on good engineering practice which shall–
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.
  1. Where applicable, licensees shall make suitable arrangements with suppliers of radiation generators and radioactive sources, the Bureau 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.
–(1) 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. {Such equipment to conform to applicable technical standards such as IEC and ISO equivalent standards may be specified by the Bureau;
  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 (a language understandable to the users) (state the language here).
2. ensuring that radiation generators and radioactive sources are tested to demonstrate compliance with the relevant specifications;
3. making information available, (state the language here), on the proper installation and use of the radiation generator or radioactive source and its associated radiation risks, including performance specifications, instructions for operating and maintenance, and instructions for protection and safety {in compliance with the relevant IEC and ISO standards with regard to accompanying documents};
4. ensuring that the protection provided by shielding and by other protective devices is optimized.
  1. Licensees shall ensure that sealed sources are categorized in accordance with the categorization scheme set out in Schedule II of GSR Part 3 [3], and in accordance with the requirements of the Bureau.
  2. 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 applicable symbols.
  3. Licensees, in cooperation with manufacturers, shall ensure that, where practicable, sealed sources are identifiable and traceable.
  4. Licensees shall ensure that when radioactive sources are not in use they are stored in a manner to prevent exposure and the optimisation of protection and safety.
    
    Supply and Procurement of Radioactive Sources.
    
    Export of Radioactive Sources
  5. Licensees shall ensure that arrangements are in place for the safe management of and control over radiation generators and radioactive sources, including financial provision, once taken out of use.
–(1) Licensees who supply or distribute radioactive sources shall ensure that those persons to whom the sources are being supplied are authorized to receive the sources.
1. Before purchasing, or otherwise acquiring, radioactive sources, licensees shall–
  1. make arrangements are made for the safe management of the source(s) including financial provisions once they have become disused;
  2. submit to the Bureau details of those arrangements, including copies of any contractual arrangements.
2. Licensees supplying radioactive sources or devices incorporating radioactive sources shall provide the recipient with all relevant technical information to permit their safe management.
PART XI

Import and export of radioactive sources
–(1) Any person intending to export radiation generators and radioactive sources shall apply to the Bureau body for an export licence.
1. The application for licence to export a source or sources shall include a copy of the recipient licence to receive and possess the source or sources to be exported that includes the following information–
  1. name of the recipient;
  2. recipient location and legal address or principal place of business;
  3. relevant radionuclides and radioactivity;
  4. uses of the source;
  5. recipient authorization expiration date (if any).
2. Other information to be submitted as part of the application for authorization to export may include, as applicable–
  1. copies of relevant parts of any contractual agreements to re- import the source;
  2. justification or explanation of any need to use the ‘exceptional circumstances’ provisions in …… {reference [5]}, if applicable.
3. After receiving authorization to export the source(s), licensees shall ensure that–
  1. the export of the source(s) is conducted in compliance with all applicable transport requirements of the IAEA Regulations for the Safe Transport of Radioactive Material
    [27]; and
  2. the importing State is notified in advance (at least 7 days to the extent practicable) of each shipment with the following information in writing–
    1. the estimated date of export;
    2. exporting facility;
    3. recipient;
    4. radionuclide(s) and radioactivity;
    5. aggregate activity level;
    6. the number of radioactive sources and, if available, their unique identifiers.
  3. for Category 1 sources only, the notification described above should be accompanied by a copy of the importing States consent to import the sources, if applicable.
–(1) Any person intending to import radioactive generators and other radioactive sources shall apply to the Bureau for an import licence.
1. The application for licence to import a source or sources shall include the following information–
  1. Name of the exporter;
  2. Exporter location and legal address or principal place of business;
  3. Name of the recipient;
  4. Recipient location and legal address or principal place of business;
  5. Relevant radionuclides and radioactivity;
  6. Uses of the source;
    
    Import of Radioactive Sources
  7. Details of the arrangements for the safe management of the source(s), including financial provisions once they have become disused, including copies of any contractual agreements;
  8. Justification or explanation of any need to use the ‘exceptional circumstances’ if applicable.
2. After receiving authorization to import the source(s), licensees shall, to the extent possible, ensure that the import of the source(s) is in compliance with all applicable transport requirements of the IAEA Regulations for the Safe Transport of Radioactive Material.
General Responsibilities in respect of radioactive waste.
PART X

Management of Radioactive Waste
–(1) A licensee shall be responsible for the safety of predisposal waste management in connection with the activity which is the subject of the authorization, and shall ensure an adequate level of protection and safety by the utilization of various means, including–
1. demonstration of safety by means of the safety case and, for an existing facility or activity, by means of periodic safety reviews;
2. preparation and implementation of operating procedures, including monitoring;
3. application of good engineering practice;
4. establishment and implementation of a management system;
5. ensuring that staff are trained, qualified and competent;
6. establishing and implementing an overall strategy for management of radioactive waste that is generated, including waste that has arisen from past practices, and for providing financial security therefor, taking into account interdependencies among all steps in waste management, the available options, the Radioactive Waste Management Policy and any other policy document specified to be applicable, by the Authority on its official website;
7. establishing and maintaining mechanisms to provide and ensure adequate financial resources to discharge its responsibilities;
8. derivation of operational limits, conditions and controls, including waste acceptance criteria, to assist with ensuring
  
  that the predisposal radioactive waste management facility is operated in accordance with the safety case;
9. ensuring that generation of radioactive waste is kept to the minimum practicable, and that radioactive waste is managed by classification, segregation, treatment, conditioning, storage and disposal;
10. ensuring that there are no unavoidable delays in processing waste and that each stage of the process is proceeded with as soon as practicable; and
11. using relevant international experience to ensure that operations are as safe as practicable.
  1. The licnesee shall be responsible for the safe management of radioactive waste generated by the activity which is the subject of the authorization, and shall take all necessary measures to ensure that–
    1. generation of the activity and volume of the radioactive waste are kept to the minimum practicable, by suitable design, operation and commissioning of its facilities;
    2. the radioactive waste is managed by classification, segregation, treatment, conditioning, storage and disposal, and the maintenance of records with respect thereto;
    3. disposal of the radioactive waste is not unnecessarily delayed; and
    4. all required reports are made to the Authority within the intervals specified in the authorization, including reports relating to changes in ownership of the waste.
–(1) No person or organization shall generate, keep or manage radioactive waste, except in accordance with a licence issued by the Authority.
1. An application for a licence under paragraph (1) shall set out all the elements of management of radioactive waste in respect of which the licence is sought, which may include, for example–
  1. waste generation;
  2. predisposal, pre-treatment, characterization, treatment, conditioning, storage, clearance or transport, of radioactive waste;
  3. the control of discharges;
  4. packaging strategies;
    
    License Application for radio active waste.
  5. the design and manufacture of containers;
  6. the handling of waste packages;
  7. the site evaluation, design, construction, operation, closure and the post-closure stages, of the waste management facility concerned.
2. An application for a licence under paragraph (1) shall–
  1. be accompanied by a safety case and supporting safety and environmental assessments, in a form satisfactory to the Authority, and which is commensurate with the complexity of the activities for which the licence is sought and their potential impact;
  2. include a description of how all the safety aspects of the facility, the design, operation, shut down and decommissioning, and the managerial controls, satisfy the requirements of the Radioactive Waste Management Policy and any other applicable policy document and, in particular, the measures for reducing hazards posed to workers, members of the public, and the environment, during normal operation and in possible accident conditions; and
  3. demonstrate the level of protection provided, and supply such assurances, as the Authority may require, that the requirements of these Regulations and the Radioactive Waste Management Policy, and any other policy document specified by the Authority on its website to be applicable, will be met.
3. The safety case mentioned in paragraph (3) shall be progressively developed and refined by a licensee, or prospective licensee (as the case may be), as the waste management facility in respect of which the licence is issued or sought develops, and, in particular, shall be updated when–
  1. there is any significant change that may affect the safety of the facility or activity;
  2. there is any significant development in knowledge and understanding of the process (such as developments arising from research or operational experience feedback);
  3. there is an emerging safety issue owing to a regulatory concern or an incident; or
  4. there is any significant improvement in assessment techniques, such as computer codes or input data used in the safety analysis.
4. An applicant for a licence to operate a radioactive waste storage facility shall demonstrate that the design and cost of the facility–
  1. ensures sufficient storage capacity to account for uncertainties in the availability of facilities for treatment, conditioning and disposal, and taking into account the possible need to process waste arising from incidents or accidents;
  2. is suitable for the expected period of storage, preferably using passive safety features, and taking into account–
    1. the potential for degradation; and
    2. natural site characteristics that could impact performance (such as geology, hydrology and climate);
  3. allows for waste to be inspected, monitored and preserved in a condition suitable for release or transportation;
  4. ensures containment of waste with consideration given to interactions between the waste, the containers and their environment; and
  5. makes provision for the retrieval of the waste whenever required, and in the case of disposal of radioactive waste from mining and mineral processing, shall specify the proposed options to be followed in respect of the siting, design, construction, operation, closure and post-closure activities of the facility.
5. The Authority shall grant an application for a licence under this regulation if the Authority is satisfied, having regard to the information submitted to the Authority under this Regulation, that the conception of the facility is consistent with the Radioactive Waste Management Policy, and any other applicable policy document.
6. Where the Authority is not satisfied as mentioned in sub-regulation (6), the Authority shall refuse the application and shall advise the applicant, in writing, of the refusal, giving the reasons therefor.
–(1) A licensee shall establish and submit to the Authority for approval and, upon obtaining such approval, implement, a management system for the facility concerned, which system shall contain at least the following elements–

Management system for radioactive waste.
1. policy and procedures that identify safety as being of the highest priority;
2. clear lines of authority for decisions on safety and compliance with procedures and processes;
3. organizational arrangements and lines of communication that result in the appropriate flow of information on safety at and between the various levels in respect of the entire facility;
4. clear specification of safety responsibilities for each individual;
5. responsibilities for compliance with system requirements;
6. clear requirements that problems affecting safety must be promptly identified and corrected in a manner commensurate with their importance;
7. provision requiring each individual to be suitably trained and qualified;
8. a quality assurance programme that–
9. provides information on the performance of the radioactive waste management system and equipment;
  1. establishes a review regime in respect of the system; and
  2. ensures that all necessary records are maintained and are readily retrievable when required;
  1. provisions to ensure that where information is received in confidence from another party, the confidentiality of the information is preserved and the information is only disclosed to a third party with the consent of the other party; and
  2. provisions to ensure that the facility has sufficient capacity to process and store radioactive waste, having regard to the technological requirements of the facility and the requirements of the Radioactive Waste Management Policy, and any other applicable policy document.
  1. The Authority shall approve a management system submitted for its approval under paragraph (1), if the Authority is satisfied that the system contains the elements set out in paragraph (1) and provides–
    1. adequate assurance that the protection and safety measures will be met; and
    2. assurance that the components of the safety systems are quality sufficient for their tasks.
  2. A licensee shall–
    1. promote and maintain a strong safety culture;
    2. take account of interdependencies in all steps in the predisposal management of radioactive waste and the impact of the anticipated disposal options, and manage those interdependencies so far as is practicable so that disposal is affected in an integrated manner that does not compromise safety;
    3. ensure that the facility is operated in accordance with–
      1. documented procedures;
      2. the regulations and all terms and conditions of the licence.
–(1) If required by the Authority to do so, the licensee shall appoint a suitably qualified person to be the Radioactive Waste Management Officer.

(2) The function of a Radioactive Waste Management Officer shall be to assist the licensee in the safe and efficient on-site management of radioactive waste.
–(1) In respect of all radioactive waste management activities under its responsibility, a licensee shall develop a comprehensive recording system that includes discharges and allows for traceability of radioactive waste from the point of its collection through to its long term storage and its disposal.
1. A licensee shall ensure that all records related to radioactive waste inventory (including disused sources) and radioactive waste management activities (including changes to waste characteristics during processing) are–
  1. maintained up to date; and
  2. retained in such a way as to ensure that relevant information is accessible as necessary; and
  3. supplied to the Authority upon request.
2. Where a licensee transfers waste, the licensee shall ensure that the transfer is done under an arrangement which provides for the licensee to be furnished with records as to the steps taken in respect of the waste after transfer.
–(1) A licensee shall prepare and submit to the Authority for approval an emergency plan, in accordance with regulation 87, that–
1. includes arrangements for the licensee’s radioactive waste management and inventory;
  
  Radioactive Waste Management Officers.
  
  Radioactive waste records and reports.
  
  Emergency preparedness.
  
  Security.
  
  Nuclear safeguards.
2. defines on-site responsibilities and takes into account off- site responsibilities of other organizations with respect to implementation of the plan;
3. characterizes the content, features and extent of a potential emergency, taking into account the results of any accident analysis and the lessons learned from operating experience and from accidents that have occurred with sources of a similar type;
4. identifies the various operating and other conditions of radioactive waste inventory, which could lead to the need for intervention;
5. describes the methods and instruments for assessing the accident and its consequences on and off the site;
6. provides for protective actions and mitigation actions, and assigns responsibilities for initiating and discharging those actions;
7. provides for rapid and continuous assessment of the accident as it proceeds, and determines the need for protective actions;
8. allocates responsibilities for notifying the relevant authorities and for initiating intervention;
9. provides procedures, including communication arrangements, for contacting and obtaining assistance from any relevant organizations, such as fire-fighters, police and medical personnel;
10. provides for training personnel involved in implementing emergency plans to engage in rehearsals at appropriate intervals; and
11. provides for the periodic review and updating of the plan.
  
  (2) The Authority shall approve a plan submitted to it under this regulation if satisfied that the plan complies with paragraph (1).
A licensee shall take measures to ensure the physical security of its radioactive waste management facilities, and, in particular, to prevent the unauthorized access by individuals and the removal of radioactive materials.
In the design and operation of its waste management facilities, a licensee shall consider nuclear safeguard requirements, and shall implement those requirements in such a way as not to compromise the safety of the facility.

Pre-disposal Management of Radioactive Waste
–(1) A Licensee who generates radioactive waste shall ensure that measures are taken to keep the generation of radioactive waste to the minimum practicable.
1. The measures contemplated by paragraph (1) may include–
  1. applying care to the planning of the design, construction, administration, operation and decommissioning of facilities;
  2. reusing and recycling materials;
  3. the authorized discharge of effluent and clearance of materials after appropriate processing or a sufficiently long period of storage, so as to reduce the amount of radioactive waste that needs further processing or storage;
  4. minimizing the activity and volume of waste by using the minimum quantity of radioactive material needed;
  5. whenever possible, when purchasing sealed sources, establishing contractual arrangements for the return of sealed sources to the manufacturer, or a pre-determined waste manager, after use;
  6. implementing a comprehensive management system for all activities potentially generating radioactive waste; and
  7. maintaining consistency with the radioactive management policy and strategy.
A Licensee shall categorize radioactive waste in terms of its physical, mechanical, chemical, radiological and biological properties, in accordance with the Radioactive Waste Management Policy and any other policy document specified by the Authority to be applicable, on its official website.
–(1) A licensee shall identify, set out in a list, and submit to the Authority, as part of the safety case required under regulation 65, the licensee’s waste acceptance criteria for each step of the waste management process.
1. For the purposes of this regulation, the waste acceptance criteria shall–
  
  Control of radioactive waste generation.
  
  Radioactive waste characterization and classification.
  
  Acceptance criteria for radioactive waste.
  1. take into account the other steps within the waste management process;
  2. for each step of the waste management process, specify the characteristics of waste packages and unpackaged waste, under normal and abnormal conditions to be processed, stored or disposed of in that step;
  3. specify the known or likely requirements for subsequent disposal of the radioactive waste; and
  4. be in accordance with IAEA Guideline SSR 5.
2. A licensee shall ensure that–
  1. a control system is established to provide confidence that the waste under its responsibility meets its waste acceptance criteria;
  2. radioactive waste to be transferred to other installations or to other waste management steps meets the waste acceptance criteria established by the licensee of the installation;
  3. the licensee’s procedures for receiving waste contain provisions for safely identifying, assessing and dealing with waste that fails to meet the acceptance criteria, for example by taking remedial actions or by returning the waste.
Processing radioactive waste.
–(1) A licensee shall comply with the provisions of this regulation in processing radioactive waste.
1. Radioactive material for which no further use is foreseen, and having characteristics that make it unsuitable for authorized discharge, authorized use or clearance from regulatory control, shall be processed as radioactive waste.
2. A licensee shall ensure that–
  1. radioactive waste is collected, characterized and segregated, at the point of origin, in accordance with–
    1. established criteria;
    2. a defined waste management strategy; and
    3. the waste acceptance criteria defined for the next step in the waste management process;
  2. radioactive waste is rendered into a safe and passive form for storage or disposal as soon as possible;
  3. radioactive waste is processed in such a way that the safety of the operations is ensured during normal operations, that measures are taken to prevent the occurrence of incidents or accidents and that provisions are made to mitigate the consequences if accidents occur;
  4. the processing of radioactive waste is consistent with the type of waste, the possible need for its storage, the anticipated disposal method, and the limits, conditions and controls established in the safety case and in the assessment of environmental impacts;
  5. radioactive waste is processed in such a way that the resulting waste form can be safely stored and retrieved from the storage facility until its ultimate disposal; and
  6. consideration is given to the consequences of dealing with any secondary waste (whether radioactive or nonradioactive) that is created during processing.
–(1) In selecting a conditioning process for radioactive waste, a licensee shall consider–
1. whether safety would be improved from the use of a matrix material;
2. compatibility of the radioactive waste with the selected materials and processes; and
3. the minimization of the generation of secondary radioactive waste.
  1. A licensee shall ensure that–
    1. waste packages are designed and produced so that radionuclides are confined under both normal conditions and accident conditions that may occur during handling, storage or disposal; and
    2. each package of conditioned waste is provided with a label bearing the identification number and other relevant information and that a proper record of each package is kept under the management system.
The Licensee shall–
1. prior to generating radioactive waste that may require subsequent management, ensure the availability of a storage facility within their own organization, or in another authorized facility;
2. in arrangements for the storage of radioactive waste, comply with the Radioactive Waste Management Policy and any other policy document specified by the Authority, on its official website, to be applicable;
  
  Conditioning.
  
  Storage of radioactive waste.
  
  Radiation source inventory.
3. implement measures to ensure that radioactive waste and disused sealed sources are stored in containers, packages and facilities that meet the specifications set out in the safety case approved by the Authority;
4. ensure that radioactive waste is stored in a manner that ensures–
  1. proper segregation;
  2. protection of workers, the public and the environment;
  3. enables inspection, monitoring, retrieval and preservation in a condition suitable for movement, handling, transportation and disposal;
5. ensure that full traceability of waste packages by means of record keeping and adequate labelling is maintained during the different stages of storage;
6. ensure that the integrity of stored waste packages is maintained until they are retrieved for further treatment, conditioning or disposal and is such as permits–
  1. retrieval at the end of the storage period;
  2. enclosure in an overpack if necessary;
  3. transport to, and handling at, a disposal facility; and
  4. compliance with relevant waste acceptance criteria;
7. where the Radioactive Waste Management Policy or any other policy document specified by the Authority, on its official website, to be applicable requires that radioactive waste be stored in a centralized facility, ensure that waste is promptly transferred to that facility; and
8. ensure that the adequacy of its storage capacity is periodically reviewed, with account taken of–
9. the predicted waste arising both from normal operation and from possible incidents;
  1. the expected lifetime of the storage facility; and
  2. the availability of disposal options.
Authorization holders shall–
1. at least annually, review their radiation source inventory to identify any sources that have become disused;
2. include disused sources on their inventory of radioactive material;
3. ensure that all regulatory requirements in respect of disused sources are complied with;
4. make all reasonable efforts to return a disused radiation source to its supplier before determining that the source is radioactive waste;
5. ensure that the continuity of control is maintained once a radiation source becomes disused;
6. periodically review the status of control of their disused radiation sources; and
7. unless the authorization otherwise allows, promptly transfer their disused radiation sources to a centralized, or other approved, radioactive waste management facility.
Whenever the exercise of an option to recycle and reuse radioactive material or radiation sources requires the transfer of ownership of the radioactive material or radiation source to another organization, the licensee shall ensure compliance with regulation 61 (supply and procurement of radiation sources).
–(1) The licensee shall, before discharging any radioactive materials into the environment–
1. determine the characteristics and activity of the material to be discharged, and the possible points and methods of discharge;
2. determine by a pre-operational study all significant exposure pathways by which discharged radionuclides could give rise to exposure of members of the public;
3. assess doses to the representative person due to the planned discharges;
4. consider the radiological environment impacts in an integrated manner with features of the system of protection and safety, in accordance with the requirements of the Authority;
5. submit the authorization holder’s findings in respect of the matters set out in sub-paragraphs (a) to (d) to the Authority in writing and obtain authorization for the discharge.
  
  Recycling and reuse.
  
  Discharge of radioactive materials into the environment.
  1. The Authority shall utilize submissions made to it under paragraph (1)(e) as a basis for establishing authorized limits on discharges and conditions on their implementation and take those limits into account in determining whether to authorize a discharge pursuant to that paragraph.
  2. During the operational stage, the licensee shall–
    1. keep all radioactive discharges as far below the authorized limits established by the Authority as is reasonably achievable;
    2. monitor and record the discharges of radionuclides with sufficient detail and accuracy to demonstrate compliance with the authorized discharge limits and to permit estimation of the exposure of the representative person;
    3. maintain a management system for the activities related to effluent and environmental monitoring;
    4. report its discharges of radioactive material into the environment to the Authority at such intervals as are specified in the authorization and forthwith report all discharges that exceed the authorized limits established by the Authority; and
    5. review the authorization holder’s operating experiences in respect of discharges of radioactive material and, with the approval of the Authority, adjust the authorization holder’s discharge control measures to ensure optimization of protection and safety.
  Clearance and control of entrance.
–(1) Where an applicant for authorization intends to clear radioactive material from regulatory control during the operational stage, that applicant shall disclose that intention to the Authority in the application.
1. In respect of clearance and the control of clearance, the licensee shall adopt provisions that ensure that–
  1. the clearance of radioactive waste complies with clearance levels approved by the Bureau;
  2. a formal mechanism is in place, including rigorous control measures, to demonstrate compliance with regulatory controls in respect of clearance;
  3. deliberate dilution of material, other than the dilution that takes place in normal operations, is not carried out;
  4. radiation markings are removed from material in respect of which regulatory controls no longer apply, and such information as the Authority requires, regarding material to which regulatory controls no longer apply, is recorded and supplied to the Authority.
PART XII

Responsibilities associated with the predisposal management of radioactive waste
–(1) The licensee shall be responsible for the safety of predisposal waste management facilities or activities of disused sources.
1. In the disposal of radiation generators, the Licensee shall–
  1. dismantle the generator so that there is no possibility of reconnection so as to be regarded as scrap metal; and
  2. be disposed of as waste metal
2. Licensees shall ensure an adequate level of protection and safety by various means, including–
  1. demonstration of safety by means of the safety case, and for an existing facility or activity, by means of periodic safety reviews;
  2. preparation and implementation of operating procedures, including monitoring;
  3. application of good engineering practice;
  4. establishment and implementation of a management system;
  5. ensuring that staff are trained, qualified and competent;
  6. establishing and implementing the overall strategy for radioactive waste management that is generated, including waste that has arisen from past practices, and for providing financial securities, taking into account interdependencies among all steps in waste management, the available options and the national radioactive waste management policy;
  7. establishment and maintenance of a mechanism to provide and ensure adequate financial resources to discharge its responsibilities;
  8. derivation of operational limits, conditions and controls, including waste acceptance criteria, to assist with ensuring
    
    General Licensee Responsibility in relation to radioactive waste.
    
    that the predisposal radioactive waste management facility is operated in accordance with the safety case;
  9. ensure that generation of radioactive waste is kept to the minimum practicable and that radioactive waste is managed by classification, segregation, treatment, conditioning, storage and disposal;
  10. ensure that there are no unavoidable delays in processing waste and transferring to the next step as soon as practicable;
  11. use relevant international experience to ensure operations are as safe as practicable.
3. The licensee may delegate any work associated with the aforementioned responsibilities to other organizations but shall retain overall responsibility and control.
4. The licensee may use cost-benefit arguments to justify its proposed program, as long as safety limits are respected.
5. Licensees shall be responsible for the safe management of the radioactive waste generated by the practices or sources for which they are authorized and shall take all necessary measures to ensure that–
  1. generation of the activity and volume of radioactive waste are kept to the minimum practicable by suitable design, operation and decommissioning of its facilities;
  2. radioactive waste is managed by classification, segregation, treatment, conditioning, storage and disposal, and maintaining records of such activities;
  3. disposal of radioactive waste is not unnecessarily delayed; and
  4. reporting is made to the Bureau of required information at intervals as may be specified in the license, including those related to the changes of ownership of waste.
Location and design of radioactive waste management facilities.
PART VII.

Development and operation of waste management facilities
A licensee shall ensure that the facilities at which the licensee carries on radioactive waste management are–
1. located and designed so as to ensure safety for their expected operating lifetime, under both normal and possible accident conditions, and for their decommissioning; and
2. tested, examined and inspected periodically to ensure safety as mentioned in paragraph (a).
–(1) A licensee shall ensure, in respect of the radioactive waste management facilities at which the licensee carries on radioactive waste management, that–
1. the facilities are constructed in accordance with the design as described in the safety case and approved by the Authority;
2. commissioning of the facility is carried out to verify that the equipment, structures, systems and components of the facility, and the facility as a whole, performs as planned;
3. in cases where commissioning is carried out in several stages, the commissioning is reviewed and approved at every stage by the Authority; and
4. upon the completion of commissioning, a final commissioning report is submitted to the Authority along with the safety case updated, as necessary, to reflect the “as- built” status of the facility and the conclusions of the commissioning report.
  1. Where any modification of the facility is undertaken, that has significant safety implications that require a revision of the safety case, the provisions of this Part in respect of reporting and approval requirements shall apply as if the facility was a new facility.
  2. A licensee shall periodically review–
    1. the storage capacity of the facilities at which it stores radioactive waste, and assess the adequacy of that capacity, taking into account the predicted waste arising, the expected lifetime of the facilities and the availability of disposal options;
    2. the safety of its facilities in order to verify compliance with regulatory controls and shall make such upgrades in respect thereof as shall ensure compliance.
  PART VI.
  
  Decommissioning of Facilities and Activities
–(1) In this regulation, “end state” means a state where the facility, or all materials connected with an activity, as the case may be, is in a state fit for release from regulatory control.

Construction and commissioning of radioactive waste management facilities.

Decommissionin g facility..
1. In respect of the decommissioning of a facility or activity, the licensee shall be responsible for–
  1. ensuring the safety of workers and the public, and the protection of the environment during and after the decommissioning;
  2. establishing a decommissioning strategy and preparing and maintaining a decommissioning plan, in accordance with paragraph (4);
  3. establishing a waste management strategy for decommissioning facilities, including the identification of an acceptable destination for all wastes arising from decommissioning;
  4. performing safety assessments and environmental impact assessments related to decommissioning;
  5. preparing and implementing safety procedures, including emergency preparedness, and applying good engineering practices;
  6. ensuring that properly trained, qualified and competent staff are available for the decommissioning project;
  7. performing radiological surveys in support of decommissioning;
  8. keeping such records and submitting such reports as are required by the Authority;
  9. establishing a management system which provides for organizational and administrative controls, staffing and qualifications, project management, documentation and record keeping, definition of the parameters for the involvement of subcontractors, and safety management;
  10. ensuring that end state criteria have been met by performing a final survey; and
  11. notifying the Authority prior to permanent shut down of the facility, or termination of the activity, as the case may be.
2. A licensee shall apply a graded approach to the planning, conduct and completion of decommissioning.
3. The decommissioning plan referred to in paragraph (2) (b) shall be maintained throughout the lifetime of the facility or activity (as the case may be), unless the Authority otherwise directs, and the licensee shall–
  1. periodically review and update the decommissioning plan; and
  2. within twenty-one days before commencing decommissioning, submit to the Authority a finalized version of the decommissioning plan that–
    1. reflects all reviews and updates made pursuant to these Regulations;
    2. states the methodology and criteria that will be used to demonstrate that the proposed end state has been achieved;
    3. states how the decommissioning will be managed, including decontamination and dismantling techniques that optimize the protection of workers, the public and the environment and minimize the generation of waste;
    4. specifies the estimated decommissioning cost and indicates the financial provisions in place for the decommissioning, including the management of the resulting waste, even in the event that a premature shutdown is necessary;
    5. is accompanied by a supporting optimization analysis satisfactory to the Authority; and
    6. where any new or untried methods for decommissioning are proposed to be used, demonstrates that the use of such methods is justified and is addressed within the optimization analysis supporting the decommissioning plan.
4. The licensee shall not begin decommissioning until the finalized decommissioning plan submitted under paragraph (4) is approved by the Authority.
5. The Authority shall approve a decommissioning plan if satisfied as to the matters set out in this regulation.
6. The licensee shall adhere to the approved decommissioning plan and, on completion of the decommissioning, shall demonstrate to the Authority that the end state criteria as defined in the decommissioning plan and all other acceptable requirements under these Regulations have been met.
7. Regulatory controls shall continue to apply to a facility or activity, as the case may be, until the Authority certifies that the facility or activity is decommissioned in accordance with these regulations.
PART VIII.

Emergency Preparedness and Response

Emergency plan.
–(1) Where an activity, source, or radioactive waste, has the potential for creating an emergency affecting either workers or members of the public, the licensee shall prepare and submit to the Bureau for approval an emergency plan for the protection of people and the environment.
1. The emergency plan referred to in paragraph (1) shall–
  1. include arrangements for the prompt identification of an emergency and for determining the appropriate level of the emergency response;
  2. provide for individual monitoring and area monitoring, and arrangements for medical treatment;
  3. include arrangements for assessing and mitigating the consequences of an emergency;
  4. characterise the content, features and extent of a potential emergency, taking into account the results of any hazard assessment and the lessons learned from operating experience and from accidents that have occurred with activities, sources or waste (as the case may be) of a similar type;
  5. identify the various operating and other conditions of the source which could lead to the need for intervention;
  6. describe the methods and instruments for assessing the accident and its consequences on and off the site;
  7. provide for protective actions and mitigation actions, and assign the responsibilities for initiating and discharging those actions;
  8. provide for rapid and continuous assessment of accidents, as they proceed, in determining the need for protective actions;
  9. allocate responsibility for notifying the relevant authorities and for initiating intervention;
  10. provide procedures, including communication arrangements for contacting and obtaining assistance from the relevant response organizations (such as fire-fighters, medical personnel and the police);
  11. provide for the training of personnel involved in implementing emergency plans and for rehearsal of emergency responses at appropriate intervals.
2. Authorization holders shall be responsible for obtaining approval for, and implementing, the emergency plan required under this regulation, and shall, in accordance with the plan–
  1. develop, maintain and implement procedures to provide the means for preventing loss of control over the source;
  2. make available for use in an emergency all equipment, instrumentation and diagnostic aids that may be needed; and
  3. train and periodically retrain personnel in the procedures to be followed in the event of an emergency.
–(1) The licensee shall ensure that the protective actions or remedial actions taken by or on behalf of the licensee to reduce or avert accidental exposures are only undertaken when they are justified, taking into account health, social and economic factors.
1. The form, scale and duration of any intervention pursuant to paragraph (1) shall be optimized so as to produce the maximum net benefit under the prevailing social and economic circumstances.
2. The licensee shall forthwith notify the Authority when an accident requiring intervention has arisen, or is expected to arise, and shall keep the Authority informed as to–
  1. the state of affairs and their expected evolution;
  2. the measures taken to terminate the accident and to protect workers and members of the public; and
  3. the exposures that have been incurred and that are expected to be incurred.
–(1) The employer of an emergency worker shall ensure that the worker is not subject to exposure in excess of 50 mSv other than–
1. for the purposes of saving life or preventing serious injury;
2. when undertaking actions to avert a large collective dose;
3. when undertaking actions to prevent severe deterministic effects and actions to prevent the development of catastrophic conditions that could significantly affect people or the environment.
  1. In any of the circumstances referred to in paragraph (1)(a), (b) or (c),
    the employer shall make all reasonable efforts to–
    1. keep doses to emergency workers below the values set out in the Schedule ???; and
      
      Protective actions or remedial actions.
      
      Protection of emergency workers in emergency exposure situations.
    2. subject to regulations (3), ensure that workers who undertake actions due to which their doses could approach or exceed the values set out in Schedule ??? do so only when the expected benefits to others would clearly outweigh the risks to those workers.
  2. No employer shall require an emergency worker to undertake any action in which the doses received might exceed 50 mSv, and shall ensure that a worker who undertakes such action–
    1. understands that the worker does so voluntarily;
    2. is informed, clearly and comprehensively, in advance, of the health risks involved, as well as the available measures for protection and safety; and
    3. is, to the extent possible, trained in the actions that the worker may be required to take.
  3. Employers shall take all reasonable steps to assess and record the doses received in an emergency by emergency workers, and shall communicate all relevant information concerning the doses received and the associated health risks to the workers concerned.
  4. Where, in an emergency exposure situation, a worker–
    1. receives a dose exceeding 200 mSv; or
    2. requests medical advice, the worker shall not be required to undertake any activity in which the worker could incur further occupational exposure unless a qualified medical practitioner clears the worker for further activities involving occupational exposure.
  Tranporation.
  PART ???
  
  Transportation of radioactive material
The Licensee who transports , (whether domestically or internationally) a radiation source, radioactive waste, or any other radioactive material, shall comply with all applicable transport requirements of the iaea regulations for the safe transport of radioactive material, iaea safety standards series no. SSR-6, IAEA, vienna (2012), and any revisions thereto specified by the authority, on its official website, to be applicable.

PART XIII

Offence and Penalties
–(1) The Bureau may, by notice in writing to the licensee, suspend, revoke or modify a licence or prohibit the possession of a source if it is satisfied that–
1. there is undue threat to health and safety;
2. the licensee has not complied with or is not complying with these Regulations; or
3. the licensee has not complied with or is not complying with the terms and conditions of the licence as may be prescribed.
  1. A notice issued under this regulation–
    1. shall specify the reasons for the suspension or revocation;
    2. shall specify the date on which the revocation or suspension takes effect; and
    3. may include corrective measures to be implemented by the licensee.
  2. A notice served under sub-regulation (1) shall remain in effect until withdrawn in writing by the Bureau.
  3. A person whose licence has been suspended or revoked in accordance with this regulation shall immediately surrender his licence to the Bureau, and in any event, not later than seven days from the date of receipt of the notice, whether or not the revocation or suspension is the subject of any appeal.
Any breach or contravention of these Regulation may be punishable on summary conviction by a fine not exceeding one hundred thousand dollars or to imprisonment for a period not exceeding two years, or both.
Any person who contravenes any of the provisions of these Regulations for which no penalty is specifically provided is liable on summary conviction to a fine of one hundred thousand dollars.

PART XIV

Miscellaneous
Any person engaging in a regulated activity before the commencement of these regulations shall apply for a licence as required in these regulations within ninety days after the commencement date or such longer period as the Bureau may, in writing allow.
Suspension, revocation or modification.

Breach of regulations.

General penalty.

Transitional.

compliance with other laws.

Commencement.
–(1) These Regulations are in addition to, and not in place of, other applicable laws and nothing in these Regulations shall be construed as relieving licensees from complying with applicable laws governing safety.

(2) Nothing in these Regulations shall be construed as restricting any actions that may otherwise be necessary for protection and safety.
these Regulations shall come into force on such a date as the Minister may appoint by Order published in the Gazette.

SCHEDULE XX

[Regulations xx]

DOSE LIMITS FOR PLANNED EXPOSURE SITUATIONS OCCUPATIONAL EXPOSURE.

For occupational exposure of workers over the age 18 years, the dose limits are–
1. An effective dose of 20 mSv per year1 averaged over five consecutive years (100 mSv in 5 years) and of 50 mSv in any single year;
2. An equivalent dose to the lens of the eye of 20 mSv per year averaged over five consecutive years (100 mSv in 5 years) and of 50 mSv in any single year;
3. An equivalent dose to the extremities (hands and feet) or to the skin2 of 500 mSv in a year. Additional restrictions apply to occupational exposure for female worker who has notified pregnancy or is breast – feeding (para. 3.114).
For occupational exposure of apprentices of 16 to 18 years of age who are being trained for employment involving radiation and for exposure of students of age 16 to 18 who use sources in the course of their studies, the dose limits are–
1. An effective dose of 6 mSv per year;
2. An equivalent dose to the lens of the eye of 20mSv in a year;
3. An equivalent dose to the extremities (hands and feet) or to the skin3 of 150 mSv in a year.
  
  PUBLIC EXPOSURE.
For public exposure, the dose limits are– (a) An effective dose of 1 mSv in a year;

MADE by the Minister responsible for Trade this day of

, 2024.

HON. Dr. Denzil Douglas Minister of Trade et al

(Minister responsible for Bureau of Standards)

ST. KITTS & NEVIS:

RADIATION SAFETY AND SECURITY REGULATIONS, 2024

ST. KITTS & NEVIS

STATUTORY INSTRUMENT NO. OF 2023

RADIATION SAFETY AND SECURITY REGULATIONS, 2023.

–(1) The justification process applied to the practice of any type of human imaging procedure in which radiation is used for purposes other than for medical diagnosis or medical treatment or as part of a programme of biomedical research shall include the consideration of–

–(1) Employers and licensees shall cooperate to the extent necessary for compliance by all responsible parties with the requirements of the Regulations.

–(1) Licensees and radiological medical practitioners shall ensure that protection and safety is optimized for each medical exposure.

–(1) Licensees shall maintain for a period as specified by the Bureau and shall make available, as required, the following personnel records–

–(1) The licensee, in cooperation with other responsible parties, shall ensure that the siting, location, design, construction, assembly, commissioning, operation, maintenance and decommissioning (or closure) of facilities or parts thereof are based on good engineering practice which shall–

–(1) The licensee shall be responsible for the safety of predisposal waste management facilities or activities of disused sources.

SCHEDULE XX

MADE by the Minister responsible for Trade this day of

HON. Dr. Denzil Douglas Minister of Trade et al