NRRC-SG-07-Application For Authorization of Radioisotope Production Using Accelerators

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NRRC Stakeholders Guidelines

Kingdom of Saudi Arabia

Application for
Authorization of
Radioisotope Production
Using Accelerators Practice

NRRC-SG-007
2023
NRRC-SG-007
Classification: Public

Stakeholder Guideline
Application for Authorization of Radioisotope Production Using Accelerators Practice
2023
NRRC-SG-007

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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

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Preamble

In accordance with the provisions of the NRRC’s approved Regulations,


this stakeholder guideline describes criteria and/or techniques that are
considered appropriate for satisfying the requirements stipulated in the
NRRC’s regulations.
This stakeholder guideline has been prepared on the basis of Interna-
tional Atomic Energy Agency (IAEA) standards, as well as the and the
international best practices and the experiences of similar international
regulatory bodies, and in accordance with the Kingdom’s international
commitments, and it has been approved by the NRRC’s CEO resolution
No. 1408 dated 23/07/2023.

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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

Contents

1. Purpose 3
2. Scope 3
3. Definitions 3
4. Abbreviations 4
5. Authorization Stages 4
5.1 Stage 1: Site authorization 4
5.2 Stage 2: Design, Construction, and installation of
the accelerator and other equipment 5
5.3 Stage 3: Testing and commission 6
5.4 Stage 4: Operation 6
5.5 Stage 5: Decommissioning 7
6. Relevant information in Support of the Authorization
Process 7
6.1 General and Administrative Information 7
6.2 Integrated Management System (Applicable for Stage 2 and 4). 7
6.3 Technical information (Applicable for Stage 2, 3 and 4). 8
6.4 Safety Assessment (Applicable for Stage 2 and 4). 10
6.5 Radiation Protection Programme (Applicable for Stage 2, 3 and 4). 10
6.6 Radioactive Waste Management Plan (Applicable for
Stage 2, 3 and 4). 12

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6.7 Emergency Preparedness and Response Plan


(Applicable for Stage 2, 3 and 4). 12
6.8 Testing and Maintenance of Equipment
(Applicable for Stage 3 and 4). 13
6.9 Security of Radioactive Sources Plan
(Applicable for Stage 2, 3 and 4). 14
6.10 Transport of radioactive material
(Applicable for Stage 2, 3 and 4). 15
6.11 Decommissioning Plan (Applicable for Stage 2 and 5). 15
7. Related Documents and Files 16

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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

1. Purpose
Nuclear and Radiological Regulatory Commission (NRRC) has devel-
oped an effective regulatory framework for the safe and secure autho-
rization of radioisotopes production in a cyclotron practice throughout
its life cycle. Under the regulatory framework, the prime responsibility
for safety and security within industrial radiography practice lies with
the authorized person.
The purpose of this guideline document is to give the applicant and/
or the authorized person clear and specific guidance on the submission
for the purpose of authorization of radioisotopes production in a cy-
clotron.
2. Scope
This guideline addresses facilities and activities who practice radioiso-
topes production in a cyclotron, in particular, will address the man-
agement system, radiation protection, safety, including storage and
transport. However, it is considered appropriate that a graded approach
in the application of the requirements will be taken into account and
should be adapted to the risks inherent to each facility.
This guideline includes the required information relating to radiation
safety and security by the NRRC in order to verify the adequacy of
the proposed safety and security measures as part of the authorization
process.
This guideline includes the required information relating to authoriza-
tion of new license, renewal as well as amendment of license.

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3. Definitions
Site
A geographical area that contains an authorized facility, authorized ac-
tivity or source, and within which the management of the authorized
facility or authorized activity or first responders may directly initiate
emergency response actions.
Commissioning
The process by means of which systems and components of facilities and
activities, having been constructed, are made operational and verified to
be in accordance with the design and to have met the required perfor-
mance criteria.
Construction
The process of manufacturing and assembling the components of a fa-
cility, the carrying out of civil works, the installation of components and
equipment, and the performance of associated tests.
Design
The process and the result of developing a concept, detailed plans, sup-
porting calculations and specifications for a facility and its parts.
Operation
All activities performed to achieve the purpose for which an authorized
facility was constructed.
Decommissioning
Administrative and technical actions taken to allow the removal of some
or all of the regulatory controls from a facility.

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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

Controlled area
A defined area in which specific protection measures and safety provi-
sions are or could be required for controlling exposures or preventing
the spread of contamination in normal working conditions, and pre-
venting or limiting the extent of potential exposures.
Supervised area
A defined area not designated as a controlled area but for which occupa-
tional exposure conditions are kept under review, even though specific
protection measures or safety provisions are not normally needed.
4. Abbreviations
Abbreviation Definition
NRRC Nuclear and Radiological Regulatory Commission
RPP Radiation Protection Program.
RSO Radiation Safety Officer.
QC Quality Control
SP Security Plan

5. Authorization Stages
5.1. Stage 1: Site authorization
5.1.1. Project Details
• Description of the facility
- Nature of the planned activities; purpose of oper-
ation
- Type of accelerator to be installed.

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- Particles to be accelerated.
- Beam specifications (Max beam current and ener-
gy)
- Type of radioactive materials that will be produced.
- Site specific requirements for the facility
• Description of the infrastructure supporting the facil-
ity, proposed vendor company and technical and sci-
entific expertise that will support the development and
operation.
• Information on the financial assurance for establish-
ing, operating, and decommissioning of the facility.
5.1.2. Proposed location of the facility, site specific information
• Location of the facility
• Site characteristics (site geography, seismology, meteo-
rology, hydrogeology,).
• Surrounded area (Road map, adjacent facilities, public
and nearby residential localities, and ground water)
• Environmental radioactivity analysis report (Back-
ground radiation on site).
• Layout and civil engineering drawings.

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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

5.1.3. During the process of site selection, particular consider-


ation should be given to potential hazards that cannot be
addressed by means of engineered measures. The hazard
analysis should also consider nearby chemical or other
industrial installations that could constitute potential ex-
ternal hazards.
5.2. Stage 2: Design, Construction, and installation of the accelera-
tor and other equipment
5.2.1. Engineering design and layout
• Clear layout of the facility
• Zoning and Ventilation (air flow, (Heating, ventilation, and
air conditioning (HVAC)) design scheme)
• Auxiliary facilities (power, cooling system)
• Physical security measures
• Fire protection
• Locate and specify the supervised and controlled areas.
5.2.2. Safety assessment
The safety assessment plan should cover the following
parameters:
• Dose map analysis:
- Hot cell and source operation scenarios.
- Maintenance and surveillance scenarios.
- Scenarios concerning public members.

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• Shielding calculation, including Monte Carlo Simula-


tion results.
• Layout of the facility and storage
- The layout needs to be given using a scale enabling
analysis, e.g., entrances, doors, windows, roof,
floors, penetrations, and adjacent offices or build-
ings. In particular, all construction materials may
be specified e.g., material, thickness and density.
Specify which sources and equipment given before
will be stored in the storage area and the maximum
capacity of the storage.
- Demonstrate that assumptions used considered ra-
diation fields produced.
- Demonstrate that doses are below dose limits, dose
constraints for workers and member of the public
are established, and doses are optimized.
5.2.3. Safety features.
• Specify position of all technical safety features and warn-
ing systems such as emergency cord or button, radiation
monitor(s) door interlocks, use of key control, sensors,
access control measures, barriers, monitors, and warn-
ing signals (i.e. audible and visible) and notices.
• Describe design and function of safety and warning sys-
tems, including independence of safety systems, their
redundancy and diversity.

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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

• Specify how fire protection manages hazard related to


the existing radioactive sources.
• Demonstrate that good engineering practice is taken
into account.
5.2.4. Importing the equipment
• The applicant must provide full technical information,
testing reports and certification from the country of its
origin for accelerator equipment prior rigging and in-
stallation.
• The applicant must get all necessary permission to im-
port the accelerator and its components and accessories.
5.2.5. Installation
• Rigging procedures
5.3. Stage 3: Testing and commission

5.3.1. Safety Interlock tests


• Accelerator safety system.
• Targtry Safety system.
5.3.2. Accelerator operating procedures
5.3.3. Beam testing procedures
5.3.4. Cold tests of transfer lines
5.3.5. HVAC testing:

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• Verifications of Negative pressure existence in pre-


defined area
• Verifications of Positive pressures existence in pre-
defined area
5.4. Stage 4: Operation
5.4.1. Acceptance test results for the equipment:
The program should address the following acceptance
tests:
• Beam energies
• Beam Current
• Acceleration efficiency
• Beam line transmission (if applicable)
• Production yield (mCi/µA.hr)
• Transfer of activity (Cold tests of transfer lines)
5.4.2. Acceptance tests results for the building:
• Building interlock system
• Access control
• Emergencies stop and “last person out” buttons.
• Signage. Room status, radiation warning light, beam-on
light, imaging in progress status, and similar function
features, warning signs.

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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

5.4.3. Radiation survey and safety measures.


The following radiation safety measurements should
address:
• Radiation survey during first beam on of the unit.
• Comprehensive facility room shielding survey (valida-
tion of facility shielding design).
• Verification of cooling system (radioactivity)
5.4.4. Operation and maintenance schedule and scheme
• Safe handling tools and devices required for operation
and maintenance of the accelerator and auxiliary equip-
ment.
5.4.5. Quality Assurance program.
5.5. Stage 5: Decommissioning
When the accelerator is no longer to be used, the permission
for decommissioning should be obtained from the NRRC and
decommissioning should be carried out in accordance with
an approved procedure laid down by the NRRC. The induced
radioactivity in the accelerator components and the structures
should be considered during decommissioning/disposal as a
radioactive waste. The licensee should submit a report on
the completion of decommissioning, which includes, safe
disposal of sources and personnel exposures received during
decommissioning. For more information, please see the
application guide for authorization of decommissioning.

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6. Relevant information in Support of the Authorization Process


6.1. General and Administrative Information
The applicant should fill the licensing application form at the
NRRC’s Website.
6.2. Integrated Management System (Applicable for Stage 2 and 4).
6.2.1. Provide management structure and responsibilities,
including the following:
• Describe overall organizational system and integrated
management system assuring that protection and safety
and security are effectively incorporated into the overall
management system of the applicant.
• Describe and clearly define responsibilities for radiation
safety and security for the following parties as appro-
priate: RSO(s), person responsible for security, workers,
itinerant workers, radiation safety committee including
responsibilities for cooperation and consultation.
• Provide security roles and responsibilities.
Document the assignment of all roles and
responsibilities with respect to the security of
radioactive material, including the roles and
responsibilities of the following:
- Site leadership, management, and supervisors.

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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

- Positions directly responsible for the security of radio-


active material.
- Positions with responsibility for regulatory matters,
including any positions such as the licensee, radiation
safety officer, security personnel, advisers, guards, and
other security related positions specifically required by
regulation. Provide an organization chart showing the
staffing structure with lines of authority and supervi-
sion to demonstrate how the security organization and
responsibilities fit within the overall site organization.
6.2.2. Provide description of regular assessment of protection
and safety and security such as Quality Control (QC)
program and plans for regular reviews.
6.2.3. Provide the following procedures and programs to the
NRRC.
• Radiation source inventory, supply of sources, prior as-
sessment of the radioactive sources and radiation gen-
erators and inventory of disused sources.
• Education, training and competence of the staff and
their training, retraining, and informing.
• Investigation of incidents and accidents.
• Emergency preparedness and response.
• Control of modification(s) of facilities, equipment, and
activity.
• Management of disused sources.

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• Safe transport.
• Import and export of radioactive sources.
• Control of visitors.
• Program for the improvement of the integrated man-
agement system.
6.3. Technical information (Applicable for Stage 2, 3 and 4).
6.3.1. Equipment
The applicant should provide detailed description of the
following equipment:
• Description of the Cyclotrons (technical and operation-
al characteristics, shielding, access points, under pres-
sure, alarms, flow velocity, indication of flow, finishing
of surfaces and materials).
• Description of the hot cells, laminar fume hoods.
• Description of the synthesis and dispensing modules to
be used, model, manufacturer, capabilities.
• Compressed air and gas systems;
• Special drains system for liquid radioactive effluents
and decay or delay systems;
• Back-up or emergency electrical system: should supply
services essential for safety such as: emergency lighting,
safety systems, radiation protection systems, etc.;
• Radiation monitoring system: identification and de-
scription of equipment, location;
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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

• Fire detection and extinguishing system;


• Air conditioning;
6.3.2. Design of the facility
The applicant should provide detailed information about the
following facility’s components:
• Layout: showing the location of the facility relative to its
neighbourhood and surroundings.
• Axial and transverse sections showing premises adja-
cent to the facility, indicating materials, wall thickness-
es, service penetrations in shielding (electrical and ven-
tilation ducts, transfer, cooling and gas lines, etc.);
• Plan of the facility: distribution and function of, and
operations to be performed in the facility’s premises
and adjacent premises, plus an estimate of occupation
factors, including delimitation of the controlled and su-
pervised area and adjoining areas;
• Communication routes between premises and equip-
ment, including their relative pressure levels;
• Location of the cyclotron and radiopharmacy labora-
tory, including the hot cells (synthesis and dispensing),
transfer lines and control room;
• Location of the quality control laboratories, dispatch
area for radioactive packages (if one exists), staff decon-
tamination area, component maintenance area, waste
storage area and technical access area to the cells. Relat-

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ed technical areas should be included such as the filter


room, stack, gas area, areas containing cooling systems,
electronic modules, etc.;
• Location of signs, emergency shutdown systems and
monitors;
• Flow of radioactive material and persons;
• Location of access monitoring systems for persons and
materials;
6.3.3. Transfer of radioactive material
The applicant should provide detailed information about
transfer lines which carry the product from the target to
the hot cell.
6.3.4. Ventilation systems
The applicant should provide description about
ventilation system, as follow:
• differential pressure values within the radioisotope pro-
duction facility.
• Types and location of the High efficiency particulate air
(HEPA)
6.4. Safety Assessment (Applicable for Stage 2 and 4).
The applicant should provide detailed information about the
following elements:
• Expected doses (occupational and from public expo-
sure) arising from normal operation of the practice.

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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

• Estimation of the potential doses (occupational and


from public exposure) from anticipated operational oc-
currences and accident conditions (failures or internal
or external events have occurred that challenge the safe-
ty of the facility or activity).
• Identification of postulated accident initiating events,
commensurate with the particular features of the prac-
tice.
• Description of the severity of the potential consequenc-
es for workers, members of the public associated with
each of the accident initiating events. Provide the eval-
uation of the consequences for workers and members
of the public based on the potential effect which each
accident initiating event could have without taking into
account the safety measures or barriers envisaged.
• Description, for each accident initiating event, of the
existing safety barriers to prevent or mitigate accidents.
• The risks associated with each accident initiating event.
Risk needs to be expressed as a function of the frequen-
cy with which the initiating event occurs, the robustness
of the safety barriers and the severity of the potential
consequences associated with each initiating event. Risk
may be classified following a prioritization principle to
facilitate further decision making.
• A program of safety measures to be carried out for
higher risk initiating events to ensure the optimization

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of protection to the highest reasonably achievable safety


level.
• Independent verification. Attach the results of indepen-
dent verification of the safety assessment.
• Review of safety assessment. Demonstrate that regular
and documented reviewing of safety assessment is in
place.
6.5. Radiation Protection Programme (Applicable for Stage 2, 3
and 4).
The applicant should provide radiation protection programme as
follow:
6.5.1. Protection of Workers
• Education and training of workers.
• Personal dosimetry records.
• Workers’ health surveillance.
• Arrangements for the Radiation Protection Program
(RPP).
Demonstrate that all elements of the RPP are in place, e.g., provide
a copy of a RPP:
- Assignment of responsibilities for the RPP.
- Designation of controlled areas or supervised areas.
- Specify designation of controlled and supervised area us-

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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

ing safety assessment and measured dose rates at working


room(s)/area(s), storages(s). Demonstrate appropriate man-
aging of labels, marks, and notices.
- Practice specific local rules.
- Demonstrate that local rules applicable for workers are pre-
pared for all processes of the applicant and that an adequate
number of workers is involved in the practice. Specify roles
and responsibilities as well as demonstrate that supervision
of processes is taking place.
- Demonstrate that rules, labels, and marks are in a language
understood by those for whom they are intended Workplace.
- Area and stack monitoring program.
- Demonstrate that the necessary amount of radiation mon-
itoring equipment is available, including stack equipment
for monitoring external environment. Specify their technical
specification, selection, calibration, maintenance, testing and
use of radiation monitoring equipment.
- Personal protective equipment.
- Demonstrate that appropriate personal protective equipment
is provided, and arrangements are made for its proper use,
testing and maintenance.
- Record and reporting of information.
- Describe the system for recording and reporting all infor-

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mation related to exposure control, decisions regarding mea-


sures for occupational radiation protection and safety as well
as individual radiation monitoring.

- Audit and review of the RPP and the Security Program (SP).
- Specify the methods for periodic auditing and review of im-
plementation of the RPP and SP.
6.5.2. Protection of Public
• System of protection and safety to protect members of the
public:
- Describe the system of protection and safety to protect
members of the public.
- Demonstrate that optimization of radiation protection
of public is in place.
- Demonstrate that assessment, control, and surveil-
lance of external exposure of public are in place, i.e.,
use of dose constraints for the member of the public.
Provide assumptions used to assess external exposure
of public.
- Describe training of personnel having functions rele-
vant to protection and safety of members of the public.
Demonstrate that monitoring program and manage-
ment of records are in place.
- Describe the use of signs, labels, marks, and notices

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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

to be noticed by members of the public. Confirm that


they are in a language to be understood by members
of the public.
6.6. Radioactive Waste Management Plan (Applicable for Stage 2, 3
and 4).
The applicant should provide radioactive waste management
plan as follow:
• Characterization of radioactive waste
• Waste minimization plan
• Handling and processing of radioactive waste
- clearance of materials after processing
- storage for decay
- reuse and recycling of material
• Water and drainage system
• Release of activated water and air to the environment
• Radioactive waste inventory
• On site decay storage
6.7. Emergency Preparedness and Response Plan (Applicable for
Stage 2, 3 and 4).
Provide Emergency Preparedness and Response Plan including
the following:
• Emergency Plans and Procedures

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• Training and Exercises


Training should cover the following:
- Procedures for notification of an emergency and acti-
vation of an emergency response, including provisions
for obtaining assistance from off‑site emergency ser-
vices.
- Implementation of necessary on‑site mitigatory ac-
tions and protective actions, including provision of
immediate first aid, and procedures for evacuation of
non‑essential personnel from facility.
- Assessment of the situation.
- Use of emergency response tools and equipment in-
cluding firefighting equipment.
- Use of personal protective equipment.
- Use of workplace monitoring equipment.
- Implementation of recovery actions, including decon-
tamination.
- Measures to be followed for the protection of person-
nel who will participate in implementing the emergen-
cy plans.

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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

• Reporting
The report should include the following:
- A detailed description of the emergency, including
specifics of the equipment and source(s) involved.
- Environmental and working conditions at the time of
the emergency, with reference to whether or not these
conditions played any significant part in causing the
emergency or affecting the outcome.
- The root causes of the emergency.
- A detailed description of the emergency response tak-
en.
- The personnel involved, the work they performed, and
their skills and qualifications.
- An assessment and summary of the doses received by
all affected individuals.
- Corrective actions identified with the aim of prevent-
ing similar emergencies in the future and necessary for
improving overall radiation safety, security, and emer-
gency arrangements.
- Proposed means and time frames for implementation
of the corrective actions identified and responsible
staff.

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6.8. Testing and Maintenance of Equipment (Applicable for Stage 3


and 4).
Provide procedures for maintenance which includes the
following:
• The ventilation system (buildings, hot cells, fume hoods) at
least annually.
• The heating and cooling systems, generators, radiation mon-
itoring equipment, interlocks, freezers, building monitoring
system, HEPA filters in clean rooms and dose calibrators.
• All equipment used in measuring radiation levels and weights,
as well as other equipment as required by the NRRC, should
tested, calibrated, and maintained on a regular basis.
• Check, in accordance with the manufacturer’s instructions,
that access to the facility is prevented when the radiation
monitor alarm sounds.
• The emergency exit procedure by ensuring that the personnel
access door can be opened from the inside and that other
means of exit in an emergency are functioning properly.
• Check all visual warning signals and alarms for correct op-
eration. Check all control indicator lights to ensure that they
illuminate.
• Verify that the uninterruptible power supply is functioning
within specification. It is a good practice to use an uninter-
ruptible power supply as a backup power supply for the lin-
ear accelerator control system, as power failure can affect the

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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

operation of control units.


• Verify that the heat detectors and smoke detectors are func-
tioning properly.
• Verify all safety interlocks on removable shield plugs (or
self‑shield) in the accelerator room.
• Verify that posted notices are in place and that all the details
are correct.
6.9. Security of Radioactive Sources Plan (Applicable for Stage 2, 3
and 4).
Provide security of radioactive sources plan as follow:
6.9.1. Site description.
Describe the physical features of the site on which the
practice is conducted and its surrounding environment,
including diagrams and scale floor and building drawings
and photographs.
6.9.2. Operational description.
Describe site operations in relation to the practice,
including working and non-working hours; the number
and type of staff involved in the site’s operations; and the
typical number, type, and frequency of other people, such
as visitors, public, patients, customers, service personnel
or contractors, who may be at the site during scheduled
operations or at any other time.

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6.9.3. Access authorization.


Describe the process used for authorizing personnel who
need unescorted access to radioactive source locations,
secured areas, and/or security sensitive information in
order to perform their duties (which may or may not be
directly related to security), including how the following
functions are performed:
• Identify the positions requiring unescorted access.
• Verify individuals holding the identified positions are
trustworthy.
• Verify individuals holding the identified positions have
the necessary training.
• Perform timely withdrawal of access for individuals
who no longer require it.
• Conduct periodic review and re-evaluation for particu-
lar circumstances, such as withdrawing access authori-
zation when personnel or positions no longer have need
for unescorted access, transfer of job responsibilities, or
termination of employment.
• Maintain up-to-date records of personnel authorized
for unescorted access.
6.9.4. Access control.
Describe the physical measures for controlling access,
including:

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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

• How personnel are physically controlled at each control


point to limit access only to authorized persons accord-
ing to the access authorization procedure and to pre-
vent unauthorized access.
• Specific media used to authenticate the identity of au-
thorized persons such as key card, personal identifica-
tion number, biometric device, or a combination.
• Procedures to be followed by authorized persons to
access a secured area, including application of the
two-person rule, where relevant.
6.9.5. Procedures for key and lock control.
Describe the procedures used for control of all keys,
locks, combinations, passwords, and related measures
used to control access to secured areas and security
systems. Identify who is responsible for changing
access control measures and the specific conditions that
require them to be changed, such as the compromise
of a combination or password, loss of a security key, or
termination of a staff member’s access.
6.9.6. Procedures for accounting and inventory.
Describe how the site performs periodic accounting for
radioactive material, including:
• Verification method used, such as a physical check, re-
mote video monitoring, examination of seals or other
tamper indicating devices, or radiation measurements.

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• Records generated indicating results of each verifica-


tion, when, by whom, and by what method.
• Requirements for corrective actions and reporting if
the presence of radioactive material cannot be verified.
Also describe how the site establishes and maintains an
inventory of its radioactive material.
6.9.7. Procedures for receipt and transfer of radioactive
material.
6.9.8. Security event reporting.
6.10. Transport of radioactive material (Applicable for Stage 2, 3
and 4).
The applicant should provide plan for the movement of
radioactive sources as follow:
• Responsibilities in the transport of radioactive.
• Movement plan of radioactive material within the site.
• Transport plan of radioactive material to another site.
6.11. Decommissioning Plan (Applicable for Stage 2 and 5).
The operating organization is required to prepare a decommissioning
plan for the facility that considers the ultimate disposal of all resultant
waste and contaminated and/or activated equipment and materials,
including an estimation of cost, identification of the provision of
financial resources and assurances to cover the cost associated
with decommissioning. This decommissioning plan is required to

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Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

be periodically reviewed and updated as necessary in the light of


operating experience gained, new or revised safety requirements,
lessons learned from the decommissioning of similar facilities, and
technological developments relevant to decommissioning.
6.11.1. Decommissioning plan should include:
• Justification and description (techniques and time-
frame) of the decommissioning method,
• Expected occupational exposures and measures for
their restriction,
• Assessment of the final condition of the area in
terms of radiological safety and description of its
future use, if applicable,
• Arrangements and commitments, including the re-
quired financial resources for the management and
possible transport of radioactive sources and mate-
rials and/or radioactive waste that are expected to
be produced, where applicable.
• Responsibilities for decommissioning
• Final destination of radiation sources

The operating organization should provide the NRRC with a


list of anticipated waste streams and sources to be generated at
the facility, including waste forms (e.g. solid, liquid, gaseous),
estimates of waste volumes, waste categories and plans for
storage and disposal.

32
NRRC-SG-007
Classification: Public

For more information about decommissioning, please see the


application guideline for authorization of decommissioning.

33
Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

7. Related Documents and Files


Document Document
Document Name Relation to the guideline
Type Number
This Regulation set out the
general safety requirements in
ensuring protection of people
and the environment against
the harmful effects of ionizing
radiation and for the safety of
Technical radiation sources.in addition,
Radiation Safety NRRC-R-01
Regulation this regulation harmonize the
requirements applicable in the
Kingdom with the international
best practices in order to
achieve the highest standards of
safety in activities and facilities
that give rise to radiation risks
Prescribes the general
requirements for notification
Notification on
on and authorization of
and Authorization
Technical activities, facilities and practices
of Facilities and NRRC-R-02
Regulation with radiation source, nuclear
Activities with
material and/or ore containing
Radiation Sources
uranium and thorium in the
Kingdom

34
NRRC-SG-007
Classification: Public

This regulation is to prescribe


requirements that shall be
fulfilled to ensure safety,
Safe Transport security and to protect persons,
Technical
of Radioactive NRRC-R-15 property, and the environment
Regulation
Materials from any harmful effects of
radiation on the transport of
radioactive materials or nuclear
material.
This regulation sets out the
safety objectives, criteria and
requirements for the protection
of human health and the
Management of Technical
NRRC-R-16 environment that shall be
Radioactive Waste Regulation
applied to the activities and
the requirements that shall be
met to ensure the safety of such
activities and facilities.
This regulation that addressed
security of radioactive
material, associated activity,
Security of and associated facility against
Technical
Radioactive NRRC-R-17 unauthorized removal of
Regulation
Material radioactive material and
sabotage performed with
the intent to cause harmful
radiological consequences

35
Stakeholder Guideline for Application for
Authorization of Radioisotope Production
Using Accelerators Practice

©Nuclear and Radiological Regulatory Commission , 2023


King Fahd National Library Cataloging-in-Publication Data
L.D. no. 1445/83
ISBN: 978-603-92072-4-5

36
NRRC-SG-007
Classification: Public

37
Kingdom of Saudi Arabia
@saudinrrc
nrrc.gov.sa

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