ANSllHPS N43.16-2021
ANSllHPS N43.16-2021
ANSllHPS N43.16-2021
ANSI/HPS N43.16-2021
No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise,
without prior written permission of the publisher.
ANSI/HPS N43.16-2021
ii
The ANSI/HPS N43.16 Standards Subcommittee responsible for the development of this standard had the
following members:
Ronald Amoling
American Science & Engineering, Inc.
Maria Arribas-Colon
U.S. Nuclear Regulatory Commission
Paul Bergstrom
National Institute of Standards and Technology
Gongyin Chen
Varian
Daniel Kassiday
U.S. Food and Drug Administration
Siraj M. Khan
Customs and Border Protection, U.S. Department of Homeland Security
Jeffrey Lodwick
U.S. Department of Labor, Occupational Safety and Health Administration
Daniel Madson
Leidos
Joel Sadler
L3 Communications
Mershad Shahabidin
Rapiscan Systems, Inc.
Daniel Strom
Pacific Northwest National Laboratory (retired)
John Volz
Smiths Detection
iii
The current working group gratefully acknowledges the valuable contributions from the many past
working group members who have assisted with the development of this standard. Special thanks goes to
the following past members:
Frank Cerra
National Institute of Standards and Technology (retired)
Richard Schueller
American Science & Engineering, Inc. (deceased)
Steven Seltzer
National Institute of Standards and Technology (retired)
David Hamel
U.S. Department of Labor, Occupational Safety and Health Administration
Fran Szrom
U.S. Army Public Health Center (retired)
Alex Grosso
Customs and Border Protection, U
.S. Department of Homeland Security (retired)
Luke McCormick
Customs and Border Protection, U.S. Department of Homeland Security (retired)
iv
This standard was consensus-balloted and approved by the Accredited Standards Committee N43
Equipment for Non-Medical Radiation Applications on November 11, 2020. At the time of balloting, the
N43 Committee had the following membership:
v
Foreword (This foreword is not part of American National Standard N43.16)
The use of ionizing radiation to screen vehicles and cargo containers has increased rapidly over past
decades. This technology makes it possible to rapidly screen vehicles and cargo containers for the
presence of threat items and contraband. It also minimizes the need for security personnel to open or
enter the vehicles or containers. When this technology became commercially available, little guidance
had been published for this type of radiation use. In March 2003 the HPS/ANSI Accredited Committee
N43 appointed working group N43.16 to draft a consensus standard addressing the radiation safety
aspects of the technology.
This standard applies to security screening systems used for non-intrusive inspection of vehicles and
cargo containers in which people are not expected to be present. The standard provides guidelines
specific to the radiation safety aspects of the design, maintenance, and operation of these systems. It
does not include electrical safety guidelines or any other safety, performance or use considerations
outside of the realm of radiation safety. The standard is intended for manufacturers, distributors,
installers, and users of the systems.
In setting dose limits the standard takes into consideration the minimization of the dose as balanced
against the security benefit to society. This precludes the frivolous use of the security screening systems
where no benefit is to be derived. The standard contains three informative annexes. Annex A
(informative) provides descriptions of typical systems and operational modes. Annex B (informative)
provides information on radiation measurement quantities, terminology, equipment and techniques.
Annex C (normative) provides the background and examples for obtaining dose limits around systems
based on actual operational conditions. Annex D (normative) provides techniques for performing radiation
surveys.
It is important to reiterate that this standard includes requirements for both the manufacturers and users
of screening systems. Sections 4 and 6 of this Standard contain requirements for both manufacturers and
users. Section 5 contains only manufacturer requirements. Section 7 contains user requirements. Full
compliance with this standard requires systems to be both manufactured and operated according to the
standard. Simply procuring equipment that meets all the manufacturing performance requirements does
not guarantee compliance. When there is no requirement for U.S. Nuclear Regulatory Commission
licensing or state registration, the authors of this standard recommend equivalent oversight be performed
by a qualified independent authority.
This standard does not address dose limits for intentional exposure of humans to the primary beam.
Users of systems intended to expose humans to primary beam x-rays, gamma-radiation, or both (e.g.,
pedestrians, occupied vehicles) as well as vehicles and cargo containers shall also comply with the
requirements of ANSI/HPS N43.17-2009 (Renewed as of 2018) Radiation Safety for Personnel Security
Screening Systems Using X-ray or Gamma Radiation.
Key words: cargo and vehicle screening, gamma rays, health physics, linear
accelerator (LINAC), national standard, radiation generating device (RGD),
radiation safety, sealed radioactive sources
vi
Contents
Foreword ................................................................................................................................ vi
1 Purpose and Scope ................................................................................................................. 1
2 Normative References............................................................................................................. 1
3 Definitions1
3.1 Shall and Should .............................................................................................................. 1
3.2 Specific Terms.................................................................................................................. 1
4 Federal, State and Local Regulations ..................................................................................... 4
5 Dose Limitation........................................................................................................................ 4
5.1 Dose to System Operating Crew ...................................................................................... 4
5.2 Dose to Bystanders .......................................................................................................... 5
5.3 Dose to Inadvertently Scanned Individuals ...................................................................... 5
6 System and Manufacturing Requirements .............................................................................. 5
6.1 Indicators and Controls .................................................................................................... 5
6.2 Safety Interlocks ............................................................................................................... 6
6.3 Ground Fault .................................................................................................................... 6
6.4 Labeling ............................................................................................................................ 6
6.5 Information to be Provided to the End User ..................................................................... 7
6.6 Records to be Maintained by Manufacturers.................................................................... 7
6.7 Records to be Obtained by Diealers and Distributors ...................................................... 8
7 Installation Requirements ........................................................................................................ 8
7.1 Site Selection ................................................................................................................... 9
7.2 Safety Systems ................................................................................................................ 9
7.3 Establishing the Radiation Control Area........................................................................... 9
7.4 Establishing Quality Control Parameters.......................................................................... 9
7.5 Warning Signs and Access Control ................................................................................ 10
7.6 Assessment of Potential Doses to System Operators.................................................... 10
7.7 Assessment of Potential Doses to Inadvertently Scanned Individuals ........................... 10
7.8 Documentation ............................................................................................................... 10
8 Operating Requirements ....................................................................................................... 11
8.1 Responsible Individual ................................................................................................... 11
8.2 Establish Operating Procedures..................................................................................... 11
8.3 Personnel Monitoring ..................................................................................................... 11
8.4 Personnel Training ......................................................................................................... 12
8.5 Radiation Safety Surveys ............................................................................................... 12
8.5.1 Initial and Periodic Radiation Safety Surveys ....................................................... 13
8.5.2 Routine Quality Control ......................................................................................... 13
8.6 Preventive Maintenance ................................................................................................. 14
8.7 Inadvertent Exposures ................................................................................................... 14
8.8 Records and Documentation .......................................................................................... 14
9 Informative References ......................................................................................................... 15
Annex A (Informative)
Security Screening Systems and Operations ........................................................................ 16
A.1 Imaging Technologies .................................................................................................... 16
A.1.1 Transmission Imaging .......................................................................................... 16
A.1.2 Backscatter imaging ............................................................................................. 16
A.1.3 Combined Imaging ............................................................................................... 17
A.2 Operational Modes......................................................................................................... 17
A.2.1 Moving Source Mode ........................................................................................... 17
A.2.2 Stationary Source Mode ....................................................................................... 18
A.2.3 Dual Mode ............................................................................................................ 18
A.3 Radiation Safety Implications......................................................................................... 18
vii
Annex B (Informative)
Radiation Dosimetry .............................................................................................................. 19
B.1 Radiation Dosimetry Quantities and Units ...................................................................... 19
B.2 Calculating Radiation Doses ........................................................................................... 20
B.3 Measuring Radiation Doses ............................................................................................ 21
B.3.1 Ionization chambers ............................................................................................. 21
B.3.2 Geiger Counters .................................................................................................. 21
B.3.3 Scintillation Detectors ........................................................................................... 21
B.3.4 Passive Dosimeters .............................................................................................. 22
B.3.5 Neutron Detection ................................................................................................ 22
B.3.5.1 Active Neutron Detectors .................................................................................. 22
B.3.5.2 Passive Neutron Detectors ................................................................................ 22
B.4 Air Kerma and Absorbed Dose Measurements for Compliance with
ANSI/HPS N43.16 .......................................................................................................... 22
B.4.1 Instrument Selection ............................................................................................. 23
B.4.2 Calibration ............................................................................................................ 24
Annex C )Normative)
Procedures for Measurements Made by Manufacturers ....................................................... 25
C.1 Air Kerma at a Reference location in the Primary Beam ................................................ 25
C.1.1 Equipment Required ........................................................................................... 25
C.1.2 Procedure ............................................................................................................ 25
C.2 Isodose Contours ............................................................................................................ 25
C.2.1 Equipment Required ........................................................................................... 25
C.2.2 Procedure ............................................................................................................ 26
C.3 Dose Per Scan to the Driver of the Vehicle Being Screened .......................................... 26
C.3.1 Equipment Required ........................................................................................... 26
C.3.2 Procedure ............................................................................................................ 27
C.4 Dose to an Inadvertently Scanned Individual ................................................................. 27
C.4.1 Equipment Required ........................................................................................... 27
C.4.2 Procedure ............................................................................................................ 27
C.5 Boundary of the Radiation Control Area ......................................................................... 27
Annex D (Normative)
Establishing the Boundary of the Radiation Control Area ..................................................... 28
D.1 The Radiation Control Area ............................................................................................ 28
D.2 Methodology ................................................................................................................... 28
D.3 Example Calculations ..................................................................................................... 28
D.4 Radiation Control Area Survey ....................................................................................... 29
D.4.1 Equipment Required ........................................................................................... 29
D.4.2 Procedure ............................................................................................................ 29
viii
AMERICAN NATIONAL STANDARD ANSI/HPS 43.16-2021
medium is air, this quantity is often referred to as the source housing into the volume defined by the
air kerma. collimator.
Leak test: A test to determine the integrity of the Qualified expert: A person having the
encapsulation of a sealed radioactive source. knowledge and training to assess both the
hazards presented by the specific radiation
Mobile system: A security screening system source(s) under consideration and the
designed to operate in a moving source mode. effectiveness of engineered and administrative
controls used to mitigate those hazards.
Moving source mode: An operational mode Examples of qualified experts would include, but
where the radiation source moves relative to the are not limited to, professionals certified by the
ground while the vehicle or cargo container being American Board of Health Physics, the American
inspected remains stationary. Systems operating Board of Radiology, or the American Board of
in this mode are commonly referred to as mobile Medical Physics. Regardless of certification
systems. status, the qualified expert must have knowledge
of: (1) the radiation physics associated with the
Non-intrusive inspection (NII): Detection of specific systems to be evaluated, (2) the
concealed contraband items which does not operating characteristics of the systems, (3) the
involve the opening of, or the entry of personnel facility-specific operational practices that will be
into, the vehicle and cargo container. used, (4) the operating history (problems) of
similar systems, and (5) applicable regulations
Occupancy factor: The fraction of the time and national standards.
during which the source is “on” that the maximally
exposed individual is present in the area in Quality factor (Q): An energy dependent
question. For purposes of radiation protection, dimensionless factor by which absorbed dose is
the accumulated radiation dose in an area may to be multiplied to obtain the operational quantity
be multiplied by the occupancy factor to provide called dose equivalent. The quality factor for x-
a better estimate of potential radiation doses that rays and gamma rays is 1.0.
may be received by individuals. The maximally
exposed individual is almost always an employee Radiation weighting factor (wR): An energy
at the facility rather than a member of the public. dependent dimensionless factor by which
Recommended occupancy factors for various absorbed dose is to be multiplied to obtain the
types of areas are provided in several radiation protection quantity called equivalent
publications, such as National Council of dose. The radiation weighting factor for x-rays
Radiation Protection and Measurements (NCRP) and gamma rays is 1.0.
Report No. 147, and range from 1 for offices,
laboratories, and reception area to 1/40 for Radiation area: Any area accessible to
outdoor areas with transient traffic. individuals in which radiation levels could result in
an individual’s receiving deep-dose equivalent in
Operational mode: The operational mode refers excess of 0.05 mSv (5 mrem) in 1 h at 30 cm (1
to the motion of the source relative to the ground, foot) from the source or 30 cm (1 foot) from any
see moving source mode and stationary source surface that the radiation penetrates.
mode.
Radiation control area: The physical area
Portal system: A security screening system required to safely operate the system and
designed to operate in a stationary source mode perform non-intrusive inspection, including the
where a vehicle moves through the primary beam area needed for radiation protection, physical
under the driver’s control. Note: ANSI N43.17- safety, operational concerns, and other hazards.
2009 also applies when the vehicle occupants
move through the primary beam. Radiation generating device: For purposed of
this standard, an apparatus or a device emitting
Primary beam: The radiation coming directly or capable of emitting ionizing radiation produced
from the radiation source through an aperture in by electrical means. For example, an x-ray
system or linear accelerator (LINAC).
3
ANSI/HPS N43.16-2021
Radiation safety survey: An evaluation of the Safe operation of the system includes initiating or
radiation hazards in and around an installation. It stopping the scan, verifying the system is
customarily includes a physical assessment of operating correctly, and/or controlling access to
the arrangement and use of the equipment along the inspection area. This does not include
with an assessment of the potential doses to individuals who may be remotely viewing the
individuals under the full range of expected image results, but are not directly responsible for
operating conditions. This is typically the other functions.
accomplished by a combination of on-site
measurements and calculations. Use factor (U): The fraction of time that the
primary beam is enabled.
Roentgen (R): The special unit of exposure. One
roentgen equals 2.58 × 10-4 coulomb per kilogram Very high radiation area: Any area accessible
of air. to individuals in which radiation levels from
radiation sources external to the body could result
Safety interlock: A device or group of devices in an individual’s receiving a deep-dose
with the associated control system that is equivalent in excess of 5 Gy (500 rad) in 1 h at 1
designed to sense a limit, an off-limit condition, or m (3.3 feet) from the source or 1 m (3.3 feet) from
an improper sequence of events and any surface that the radiation penetrates.
automatically prevent or terminate radiation
exposure. This is typically accomplished by 4. Federal, State, and Local Regulations
preventing access to the hazardous area or by
terminating or preventing radiation emission. Manufacturers, distributors and users of security
screening systems under this standard shall
Scattered radiation: Radiation whose path or comply with all applicable requirements in the
direction of propagation has deviated as a result U.S. Code of Federal Regulations (CFR), which
of interaction with matter. include Title 21, Parts 1000 through 1004 and
1005.25, (U.S. Food and Drug Administration),
Sealed source: Any radioactive material or Title 10, Parts 19 & 20 and 30-33 (U.S. Nuclear
byproduct encased in a capsule designed to Regulatory Commission), and Title 29,
prevent leakage or escape of the material. 1910.1096 regarding occupational safety (U.S.
Occupational Safety and Health Administration).
Shutter: A device that, when closed, prevents the In addition, the installation, operation, and
beam from emerging from the source housing. maintenance of these systems may be subject to
When the shutter is open, the beam emerges state and local regulations. Users shall comply
from the source housing. with applicable state and local regulations, which
may involve registration, licensing, and
Skyshine: Radiation scattered by the air above a compliance with specific requirements.
radiation source to points at ground level beyond
a protective shield. 5. Dose Limitation
Source housing: An enclosure for a source that This standard does not address dose limits for
provides attenuation of the radiation emitted by human occupants of a vehicle that are
the source. intentionally exposed to the primary radiation
beam. Users conducting such operations shall
Stationary source mode: An operational mode also comply with the requirements of ANSI/HPS
where the radiation source does not move N43.17-2009 [R2019], Radiation Safety for
relative to the ground. Systems operating in this Personnel Security Screening Systems Using X-
mode are commonly referred to as portal ray or Gamma Radiation.
systems.
5.1 Dose to System Operating Crew
System operator: A person having the
necessary training and experience to safely
The annual effective dose to any member of the
operate the inspection system, and who is
system operating crew shall be less than 50 mSv
authorized by the facility to perform the process.
4
ANSI/HPS N43.16-2021
(5 rem) and should be less than 1 mSv Each system shall have a means to prevent
(100 mrem). This standard assumes all system inadvertent production or emission of the primary
operators are adults (age 18 or older). In addition, radiation beam. This may be accomplished
all doses shall be maintained as low as is through the use of a captured key, password, or
reasonably achievable (ALARA). other feature affording an equivalent level of
control.
5.2 Dose to Bystanders
Each system shall have a means for the system
The effective dose to bystanders from the operator to initiate and terminate the emission of
operation of a security screening system shall not radiation other than the function of an interlock or
exceed 0.25 mSv (25 mrem) per calendar year. the main power control.
In addition, bystanders shall not be exposed to
radiation fields that could produce an ambient Each RGD shall have two independent means
dose equivalent in excess of 0.02 mSv (2 mrem) which indicate when and only when the primary
in any one hour. beam is being emitted and which are discernible
from any point at which the initiation of radiation
In determining compliance with the annual emission is possible. Failure of a single
effective dose limit, use and occupancy factors component of the system shall not cause failure
may be taken into consideration. In determining of both indicators to perform their intended
compliance with the short term limit of 0.02 mSv function.
(2 mrem) in any one hour, only use factors may
be applied. Each system shall have one or more red lights
which indicate when and only when the primary
5.3 Dose to Inadvertently Scanned beam is being emitted. A sufficient number of
Individuals lights shall be used to ensure that at least one
light is visible from any location within the
The effective dose to an individual for a single radiation control area (as defined in paragraph
inadvertent exposure shall not exceed 5 mSv 7.3) and from any access point into the radiation
(500 mrem) and should not exceed 1 mSv (100 control area. These lights shall be designed and
mrem). positioned such that they will not be confused
with traffic control lights, if used.
6. System and Manufacturing
Requirements Each system shall have an audible warning signal
which is actuated when emission of the primary
beam begins. The audible warning signal shall be
The requirements of this section apply to the
audible above the normal ambient sound level in
original system manufacturer and to any
the area and remain on for at least 3 seconds or
individual that makes modifications to a system
until emission of the primary beam is terminated,
that affect compliance with the requirements of
whichever is less. For portal systems with
this standard.
automatic scan initiation capabilities, the audible
warning signal is only required to sound if the
All indicators, controls, interlocks, and other
primary beam has not been emitted for five
system components that affect radiation safety
minutes or more.
shall be designed to function properly under the
environmental conditions in which the system is
Each system shall be provided with emergency
designed to operate. The environmental
stop switches. At least one emergency stop
conditions under which the system is designed to
switch shall be located on the control panel. A
operate shall be clearly indicated by the
sufficient number of emergency stop switches
manufacturer.
shall be located within the radiation control area
to ensure that access to an emergency stop
6.1 Indicators and Controls
switch does not require an individual to cross the
primary beam. Following interruption of radiation
All indicators and controls shall be legibly labeled
emission by activation of an emergency stop
to indicate their purpose.
switch, resetting the switch shall not result in re-
5
ANSI/HPS N43.16-2021
initiation of radiation emission. Use of the control emission. Use of the control for initiating radiation
for initiation of radiation emission shall be emission shall be necessary (See Section 6.1).
necessary.
6.3 Ground Fault
For systems with more than one operator-
selectable operational mode, a means shall be A ground fault shall not result in the generation of
provided to indicate the selected mode at any x rays or the opening of a source shutter.
location from which a scan can be initiated. Any
controls that are not intended to be used in the 6.4 Labeling
selected mode shall be disabled.
The location or range of locations where the
A system with more than one operator-selectable primary beam exits the exterior surface of the
scan speed shall have a means to indicate the system should be indicated on the exterior
selected scan speed at any location from which a surface. If it is not indicated on the exterior
scan can be initiated. Any controls that are not surface of the system, it shall be specified in the
intended to be used at the selected scan speed operator’s manual.
shall be disabled.
Every manufacturer of a system to which this
6.2 Safety Interlocks standard applies shall provide the following
information in the form of a tag or label
Each access panel shall have at least one safety permanently affixed or inscribed on the system so
interlock that prevents emission of radiation while as to be legible and readily accessible to view
the access panel is open. In lieu of interlocks, when the system is fully assembled:
systems using a radioactive source may use two
physically locked barriers (e.g., one on the source a) The full name and address of the
shutter and one on the source enclosure). manufacturer
Systems with automatic scan initiation b) The place and date (month and year) of
capabilities must have a minimum of three manufacture
independent input signals to prevent initiation of
a scan until the driver of the vehicle to be c) The model, serial number, and any other
screened is in the designated position outside the information needed to identify the
primary beam (e.g., position sensors, driver specific design and configuration of the
position push button or card scanner). system
Systems that use a radioactive source shall have d) The radionuclide, activity of the source,
at least one shutter. Shutters shall automatically and the date of assay shall also be
close upon loss of power. Shutters shall not provided for systems containing a sealed
automatically open when power is restored. radioactive source.
Manufacturers shall determine the minimum scan e) For RGDs, the end point energy (keV or
speed (either the speed of the scanning system MeV) and current (mA), and pulse rate
or the speed of the vehicle being inspected, as (Hz) if the RGD is pulsed. If more than
applicable). An interlock shall terminate emission one energy, current, or pulse rate can
of the primary beam when the scan speed drops selected, the label shall indicate the
below the minimum scan speed. maximum value.
Failure of any single component of the system For RGDs, a warning label containing the words
shall not cause the malfunction of more than one “CAUTION: X RAYS PRODUCED WHEN
safety interlock. ENERGIZED” shall be permanently affixed or
inscribed on the system such that it is clearly
Following interruption of radiation emission by legible and visible at the location of any controls
activation of a safety interlock, resetting the
interlock shall not result in re-initiation of radiation
6
ANSI/HPS N43.16-2021
which can be used to initiate emission of the beam, current (mA), and pulse repetition
primary beam. rate (Hz) for an X-ray source, or the
identity and activity of any radionuclides
For systems containing a radioactive sealed used, the thickness and material of any
source, access to the sealed source and source filtration along the beam path, location or
enclosure shall be clearly and legibly labeled in range of locations where the primary
accordance with the sealed source and device beam exits the beam exit surface, and
registration (SSDR) and applicable federal or the beam divergence characteristics in
state regulations. both the horizontal and vertical
directions.
For systems using a radioactive source, a
warning label using the words: “CAUTION: g) The air kerma at a reference location in
RADIATION PRODUCED WHEN SHUTTER IS the primary beam and the operational
OPEN.” should be prominently displayed near the parameters under which the
source housing. measurement was made. The air kerma
shall be measured using the procedure in
6.5 Information to be Provided to the End Annex C.
User
h) Diagrams showing the dimensions and
The manufacturer shall provide information to the locations of the IDC(0.5) and IDC(20).
end user sufficient to achieve and maintain The IDC(0.5) and IDC(20) shall be
compliance with this standard, allow the safe use determined using the procedures in
of the system, fulfill requirements, and prevent Annex C.
intentional or frivolous misuse. This includes, but
is not limited to, the following: i) The dose per scan to the driver of the
vehicle being screened due to scattered
a) Warnings of life-threatening dangers radiation and the operational parameters
(e.g., unauthorized modification of the under which the measurement was made
system). (for systems in which the driver may
remain in the vehicle during screening).
b) Notification that NRC or state licensing This dose shall be measured using the
(for sealed radioactive sources) or state procedure in Annex C.
registration (for x-ray sources) may be
required. j) The dose to an inadvertently scanned
individual and the operational
c) Operational procedures needed to parameters under which the
comply with this standard. [Ordinarily measurement was made. This dose shall
these operational procedures shall be be measured using the procedure in
part of the standard operational Annex C.
procedure (SOP) for the system.]
k) The potential for neutron production and
d) A list and description of all system safety the fraction of the total dose that is due to
features (e.g., interlocks, warning lights, neutrons.
etc.)
6.6 Records to be Maintained by
e) A schedule of preventive maintenance Manufacturers
tasks, leak tests (for sealed sources),
and periodic checks of all safety features. Manufacturers shall establish and maintain the
following records with respect to systems to
f) Sufficient information about the primary which this standard applies:
beam to perform adequate radiation
measurements. At a minimum, this a) A description of quality control
information shall include the end point procedures with respect to the system’s
energy (keV or MeV) of the primary radiation safety.
7
ANSI/HPS N43.16-2021
8
ANSI/HPS N43.16-2021
regulatory requirements such as environmental The qualified expert shall determine if any
impact statements. additional site specific safety systems or controls
are required. The proper functioning of these
7.1 Site Selection additional safety features shall also be verified.
Site selection requires consideration of the 7.3 Establishing the Radiation Control Area
following:
A radiation control area shall be established
a) Space constraints around each security screening system. The
radiation dose to the maximally exposed
b) Site grading (the location should be as bystander outside the radiation control area shall
level as possible to prevent roll back) not exceed the limit specified in section 5.2. The
potential for skyshine at distances away from the
c) Occupancy of surrounding areas and radiation control area boundary shall be
adjacent structures, including areas considered.
above or below ground level
Measurements used to demonstrate compliance
d) Traffic flow into, through, and from the with this section shall be made using the
radiation control area exposure parameters that result in the highest
dose (e.g., slowest scan speed, maximum beam
e) Security issues, including access to the energy, and highest beam intensity). Acceptable
radiation control area and contingency methods for demonstrating compliance with the
plans requirements of this section, along with example
calculations, are provided in Annex D.
f) Compatibility or interference with other
systems at the site (e.g., radiation portal For security screening systems, the total area
monitors or other radiation detectors, needed to conduct screening operations is
other screening systems, etc.) determined by considerations of radiation safety,
physical safety, traffic flow and control, and other
g) Radiation safety implications if multiple operational factors. This total radiation control
radiation sources are used at the same area typically exceeds the area needed for
site. radiation exposure control. In addition, traffic flow
through the area often makes it impractical to
7.2 Safety Systems mark or control access at the boundary of the
area which would be required for radiation safety
A means shall be provided for at least one system separately from control of this larger area.
operator to maintain full visual surveillance of the Therefore, radiation warning signs and access
radiation control area. controls (see section 7.5) may be placed outside
of the boundary of this larger area and the entire
A means shall be provided for the system area treated as the radiation control area. In all
operating crew to communicate with each other. cases, the system operators shall be aware of the
For systems operating in portal mode, a means location of the radiation hazard within the area,
shall be provided to control movement of traffic ensure unauthorized individuals are not present
through the portal. during system operation, and follow established
radiation safety procedures.
Each of the system safety features (see sections
6.1 and 6.2) identified by the manufacturer, per 7.4 Establishing Quality Control Parameters
section 6.5, shall be tested for proper operation.
This shall be performed by inducing an During the initial survey, the qualified expert shall
appropriate fault condition. The assistance of the establish specific QC parameters (e.g. expected
manufacturer may be needed to induce some doses or dose rates at specific locations under
fault conditions. specific conditions) that can be easily verified by
the system operators using readily available
9
ANSI/HPS N43.16-2021
instrumentation. These QC parameters are integration of traffic sensors with safety interlocks
intended to provide the users with the ability to triggered by the failure of a vehicle to exit the
verify consistent and appropriate operation of the radiation control area within a set time.
screening system and adequacy of established
controls. This is most important for mobile or re- 7.6 Assessment of Potential Doses to System
locatable systems for which the radiation control Operators
area must be re-established after each relocation.
During the initial survey, the qualified expert shall
7.5 Warning Signs and Access Control make an assessment of the potential effective
dose to the system operators. The potential
All accessible areas in which an individual could effective dose shall be determined using the
receive a radiation dose in excess of 0.05 mSv exposure parameters that result in the highest
(5 mrem) in any one hour at 30 cm from the dose (e.g., slowest scan speed, maximum
source or closest physical barrier shall be posted number of scans per hour, maximum photon
as a Radiation Area. Additional information may energy and intensity).
be included on the signage to clarify the
conditions under which the radiation hazard is The potential effective dose to the system
present (e.g. “when red light is flashing”). operators shall be less than applicable dose limits
(see section 5.1) and ALARA.
All accessible areas in which an individual could
receive a radiation dose in excess of 1 mSv The qualified expert shall take into consideration
(100 mrem) in any one hour at 30 cm from the the potential for neutron production, primarily in
source or closest physical barrier shall be posted the accelerator head, when performing this
as a High Radiation Area. Additional information assessment. Some materials commonly used in
may be included on the signage to clarify the accelerator heads can produce photoneutrons.
conditions under which the radiation hazard is
present (e.g. “when red light is flashing”). 7.7 Assessment of Potential Doses to
Inadvertently Scanned Individuals
The maximum potential radiation dose an
individual can receive in one hour should be During security screening of vehicles and cargo
determined by multiplying the maximum number containers, there is a potential for individuals to
of scans possible in an hour by the dose per scan be present in the vehicle or cargo container for a
at 30 cm from the beam exit surface. variety of reasons. These individuals may be
If the system does not require either a radiation inadvertently scanned during the screening
area or high radiation area sign, post the area process.
with signs stating “Caution: radioactive materials”
or “Caution: x-rays”, as appropriate. The qualified expert shall determine the potential
effective dose to inadvertently scanned
These warning signs should be affixed to the individuals. The potential effective dose shall be
security screening system near the radiation determined using the exposure parameters that
source and image receptor on both sides of the result in the highest dose (e.g., slowest scan
primary beam. Where this is not possible, the speed, maximum photon energy and intensity).
signs shall be posted at the boundary of the The effective dose to an inadvertently scanned
radiation control area. individual shall be less than the limit specified in
section 5.3.
The operating crew shall have a means to control
traffic flow into and through the radiation control 7.8 Documentation
area. This shall be accomplished either by
administrative controls (e.g. ground guides) or The qualified expert shall prepare a written report
engineered controls (e.g. sensors, barriers, that documents the initial survey and the
interlocks). When traffic control is accomplished decisions made based on this information that
by the use of engineered controls, the function affect the radiation safety of the operation. At a
and integration of those controls with the security minimum this report shall include:
screening system shall be verified. For example,
10
ANSI/HPS N43.16-2021
after any change that could affect radiation 2) Sources and magnitude of common
safety. This radiation safety assessment shall be exposures;
performed by a qualified expert. The assessment 3) Units of measurement;
shall include an evaluation of the potential annual 4) Time, distance, and shielding;
dose to system operators (including the 5) The concept of ALARA;
embryo/fetus of a pregnant woman), service 6) Biological effects of radiation and
personnel, and the general public. radiation risks;
7) Emergency procedures;
The results of this assessment shall be used to 8) How to use survey
determine whether personnel monitoring is equipment/dosimetry, if applicable;
required in accordance with applicable 9) Rights of pregnant workers.
regulations and guidance. When personnel
monitoring is not implemented, the reasons shall b) Other safety hazards (e.g. physical
be documented. Even if personnel monitoring is hazards, electrical hazards);
not required, it may be conducted for a variety of
reasons including: c) Proper operating procedures, including
all indicators and controls for initiating
a) verifying the effectiveness of engineering and terminating the emission of radiation;
controls;
d) Physical security procedures to prevent
b) verifying the effectiveness of unauthorized use or access;
administrative controls;
e) System operator awareness and control
c) assessing actual individual and group of the radiation control area;
exposures;
f) Responding to public inquiries about
d) documenting exposures for regulatory or radiation;
legal purposes;
g) Familiarity with the information being
e) detecting unsafe working practices; provided to inadvertently scanned
individuals;
f) detecting changes in exposures
(including accidental exposures); h) Regulatory requirements;
12
ANSI/HPS N43.16-2021
b) at least once every three years; g) the significance of any changes from the
previous survey(s);
c) after any modification or replacement
that affects the radiation shielding, h) recommendations for root cause analysis
scattered radiation, or radiation and corrective actions, if necessary;
production components;
i) recommendations for selected
d) when making a significant change in measurements to be made during the
operating procedures beyond the initial operator’s quality control surveys
plan, such as increases in rate of
screenings, number of hours per week of
operation, or changes in occupancy of 8.5.2 Routine Quality Control
adjacent areas;
The system operators shall perform QC checks to
e) after any incident which could have ensure that the system performs consistently
damaged the system in such a way that from day to day. At a minimum the routine QC
radiation shielding, beam alignment, or checks shall include:
other radiation safety features might be
compromised. a) Prior to operating the system, the system
operators shall follow the manufacturer’s
Refer to Annex B for information on air kerma recommended start up procedure.
measurements, selection of instruments, and
estimation of effective dose. b) Daily, perform visual inspection of the
system and radiation control 13rea:
The results of the survey shall be documented 1) Check that postings are legible and
and provided to the user. At a minimum, the correctly positioned
survey report shall include: 2) Check that the radiation control 13rea
is clear (e.g. no unauthorized people,
a) the date of the survey; no debris, etc.)
3) Check that all barriers are intact and
b) name of person performing the survey; in place;
4) Check the system for damage
5) Check that warning systems (e.g.
visible and audible, as applicable) are
functional
13
ANSI/HPS N43.16-2021
8.7 Inadvertent Exposures The user shall provide a report to the individual
inadvertently exposed, if requested. Include the
estimated radiation dose and provide an example
System Operators shall cease scanning if an
that compares the radiation dose to a radiation
individual (e.g., a ground assistant or passerby)
dose from a commonly known source of radiation,
enters the radiation control area.
for example: “The radiation from this inadvertent
exposure is roughly equivalent to _______”.
In the event of an inadvertent exposure, the user
shall record the facts relevant to the exposure. At
If the radiation dose from inadvertent exposure
a minimum these facts shall include;
exceeds an applicable radiation dose limit from
section 5 above, is the result of a system
a) The nature of the inadvertent exposure
malfunction, or is related to system maintenance,
(e.g. unauthorized person in radiation the user shall report the incident. For a RGD, the
control area, unauthorized person in user shall notify the manufacturer and the
vehicle or cargo area, system operator
manufacturer shall report incident to the FDA as
out of position, etc.) required. For radionuclide based systems,
incidents will be reported to the appropriate
b) Geographic location where the regulatory agency in accordance with applicable
inadvertent exposure occurred regulations.
c) Date and time of the exposure
8.8 Records and Documentation
d) Name and age of the individual exposed
The institution operating the system shall collect
e) Contact information and maintain the following records:
14
ANSI/HPS N43.16-2021
f) Evidence and analysis to show that the International Commission on Radiation Units and
dose limits specified in Section 5 are Measurements (ICRU). 1998. Conversion
being met; Coefficients for Use in Radiological Protection
Against External Radiation. ICRU Report 57.
These records shall be maintained for 5 years or Bethesda, MD: ICRU.
more as noted above or as required by federal,
state, or local regulations. ICRU. 2011. Fundamental quantities and units for
ionizing radiation (Revised). ICRU Report 85a. J
Additionally the following information shall be ICRU 11(1a)
kept current and readily available to the system
operator: International Standards Organization (ISO).
1999. X and Gamma Reference Radiation for
a) The name and contact information for the Calibrating Dosemeters and Doserate Meters
responsible individual designated as and for Determining Their Response as a
required in Section 8.1. Function of Photon Energy – Part 3. ISO
Standard 4037-3
b) A complete set of operating procedures as
required in section 8.2 shall be readily Knoll, Glenn F. 2010. Radiation Detection and
available to the system operators. Measurement, Fourth Edition. Hoboken, NJ:
Wiley.
9. Informative References NCRP. 2004. Structural Shielding Design for
Medical X-Ray Imaging Facilities, NCRP Report
ANSI/HPS N43.3 - 2008 [Renewed 2018], For No. 147. Bethesda, MD: NCRP.
General Radiation Safety – Installations Using
Non-Medical X-Ray and Sealed Gamma Ray NCRP. 2007. Radiation Protection and
Sources, Energies up to 10 MeV, Health Physics Measurement Issues Related to Cargo Scanning
Society, Herndon, VA. with Accelerator-Produced High-Energy X Rays,
NCRP Commentary No. 20. Bethesda, MD:
ANSI/HPS N43.14 – 2011 [Renewed 2016], NCRP.
Radiation Safety for Active Interrogation of
Cargo, Energies up to 100 MeV , Health Physics Soares, C.G. and Martin, P.R. 1995. A Consistent
Society, Herndon, VA. Set of Photon Conversion Coefficients for
Personnel and Environmental Dosimetry.
Attix, F.H. 1986. Introduction to Radiological Proceedings of the Panasonic Users Group
Physics and Radiation Dosimetry. N.Y. John Meeting, Somerset, PA, June 5-9, 1995.
Wiley & Sons, Inc.
Turner, James Edward. 2010. Atoms, radiation,
Birch, Marshall, and Ardran. 1979. Catalogue of and radiation protection. Weinheim: Wiley-VCH
Spectral Data for Diagnostic X-rays. Scientific Verlag GmbH & Co. KGaA.
Report Series 30. London: The Hospital
Physicists’ Association.
15
ANSI/HPS N43.16-2021
Annex A (Informative)
Security Screening Systems and
Operations
17
ANSI/HPS N43.16-2021
where the entire vehicle is screened with the the highly collimated beam and the lower-energy
driver and/or passengers inside, the user must radiation typically used for backscatter imaging,
ensure that the requirements of ANSI/HPS doses around backscatter systems are usually
N43.17 are met (see Section 5). very low except directly along the path of the
radiation beam.
Some systems are able to operate in either The dose equivalent (H) to cargo (or an
moving source or stationary source mode (e.g., a inadvertently screened individual) can be
vehicle mounted screening system that can be estimated from the following formula (adapted
parked and operated as a portal system). from NCRP Commentary No. 20):
𝑤 𝜃𝑑
A.3 Radiation Safety Implications 𝐻= ≈ 𝐻̇
𝑣 𝑣
Each of these imaging technologies and
operational modes has implications for radiation Where, 𝐻̇ is the dose equivalent rate in the
safety and survey measurements. In primary beam, 𝑤 is the beam width (𝑤 ≈ 𝜃𝑑, θ is
transmission imaging, the detector array opposite the beam divergence in radians, d is the distance
the radiation source provides some degree of along the beam to the point where the dose is to
radiation attenuation. However, the detector be estimated), and v is the scan speed. Note that
array may not intercept the entire radiation beam unit conversion factors may be needed
and usually does not provide sufficient shielding depending on the units in which the values of
to reduce potential doses to levels required by dose rate, distance, and speed are expressed.
this standard. Therefore, additional distance
beyond the detector array is typically needed.
18
ANSI/HPS N43.16-2021
19
ANSI/HPS N43.16-2021
21
ANSI/HPS N43.16-2021
that would be delivered to human tissue. Some selection of detectors for neutron dosimetry
scintillator materials, called tissue-equivalent, primarily to passive detectors.
mimic the radiation response of muscle tissue for
a certain energy range. B.3.5.2 Passive Neutron Detectors. Allyl
diglycol carbonate (commercially known as CR-
B.3.4 Passive dosimeters 39®) is a solid-state nuclear track detector that
can be used to measure doses from neutrons.
Thermoluminescent (TL) or optically stimulated CR-39® is a plastic material (commonly used for
luminescent (OSL) dosimeters are preferred as optical lenses) which is etched after exposure to
passive detectors for dose measurement due to reveal neutron tracks in the material. These
photons. They are capable of measuring both low tracks are counted and used to determine the
and high fluence rates, and low and high doses, neutron dose. A low dose results in too few tracks
in the beam and near the scanning systems, as for accurate counting. At high doses, the tracks
well as environmental doses at distances away become superimposed and make accurate
from the source. Special calibrations may be counting difficult. As long as the doses are below
required for the high-energy photons produced by ~250 mSv (for neutrons with energies between
accelerators and buildup caps may also be 40 keV and 40 MeV) accurate measurements are
required to establish electronic equilibrium. possible. Consequently, CR-39® could be used
Subtraction of doses from naturally occurring for in-beam neutron measurements. Neutron
background radiation is required for accurate doses can be measured with CR-39® both inside
dosimetry for low doses (i.e. comparable to the and outside the radiation control area. Sufficiently
natural background). Long exposure times (e.g., long exposure times are required for these latter
from several months to a year) may be required environmental measurements to ensure that the
for both TL and OSL dosimeters used for detector threshold is exceeded for accurate
environmental monitoring due to the anticipated measurements. The detection threshold for
low fluence rates. Subtraction of background neutron measurements with CR-39® is 0.2 mSv.
dose is particularly important when carrying out CR-39® is not affected by naturally-occurring
environmental measurements. environmental photon radiation or other low linear
energy transfer (LET) radiation, and is packaged
B.3.5 Neutron Detection within the typical dosimeter so that it is protected
from environmental radon or other sources of
B.3.5.1 Active Neutron Detectors. The neutron high-LET radiation.
dose equivalent rate meters employed for dose
measurements do not operate well in pulsed, B.4 Air kerma and Absorbed Dose
mixed fields near the primary photon beam. The measurements for compliance with
response is dominated by the photon flash to ANSI/HPS N43.16
such extremes that they respond to radiation
fields as pulse counters providing essentially no This section provides general guidance on the
neutron information. However, moderator type selection and use of instruments for measuring
neutron detectors, such as rem balls, perform physical and operational dosimetric quantities.
well in low intensity, out-of-beam, pulsed fields. The wide variations in intensity and beam energy
The moderation and slowing of the neutrons in that are encountered makes the practice of
metal or concrete shielding, as well as the dosimetry very different, for example, in-beam
moderator, will stretch out the time of the neutron measurements compared to measurements at
pulses reaching the neutron sensor and reduce the perimeters of the screening system. These
the maximum dose rate in the beam. There are a situations also vary substantially from those
few available neutron dose equivalent rate encountered in the laboratories where such
meters with the response based upon foil instruments are calibrated. Appropriate
activation. Such meters are not affected by the correction factors will be discussed.
photon flash. However, the sensitivity of such
devices is limited. These considerations limit the
22
ANSI/HPS N43.16-2021
electrical charge may be produced for the approximately the charge produced in 1500 cm3
electrometer to make an accurate measurement. of air by 10 µR).
Even with a large volume ion chamber, the
electrometer itself should be very sensitive. B.4.2 Calibration
Automatic background subtraction is not
recommended. If the instrument used performs The instrument and ion chamber should be
automatic background subtraction, the process appropriately calibrated under conditions likely to
should be understood and care should be taken be encountered during use. The calibration
that all of the "real" signal is measured, taking into should be traceable to one of the NIST standard
account the time-dependent ionization rate and beams.
the sequence and duration of scanning of the
ionization chamber volume. At the present time, the highest-energy standard
calibration beam at the NIST is a Co-60 source.
The energy dependence (uniformity of response) Some inspection systems use Co-60 or, perhaps,
is also very important. The radiation fields Cs-137 sources and calibrations performed using
associated with these systems cover a large a Co-60 or Cs-137 source are directly applicable
range of energies. For measurements in the to such systems. Increasingly, high-energy
beam, a small-volume ionization chamber is accelerators are being used in inspection
recommended. If the chamber and associated systems. Once the accelerating potential
electrometer are calibrated for air kerma or for exceeds 2 MV, it is necessary to take into account
absorbed dose to water at lower energy, the differences between the calibration source
additional material should surround the chamber and the fielded system. This has been done
to increase the response to approximately its routinely for years by medical physicists. Among
maximum. This buildup material, typically a cap, the protocols developed for this purpose are
is thus used to establish electronic equilibrium those specified in the reports of Task Groups 21
within the active volume of the chamber. The and 51 of the American Association of Physicists
buildup material must be chosen so that it is fully in Medicine (AAPM).
illuminated by the beam or corrections for partial
illumination must be made.
24
ANSI/HPS N43.16-2021
25
ANSI/HPS N43.16-2021
5. Terminate radiation emission and place The measurement procedure below is only
the three water containers in a vertical applicable in situations where the entire vehicle is
stack at the center of a flatbed trailer (or not screened, but the driver is still in the vehicle.
similar support structure) in the path of If the area of the vehicle containing the driver (or
the primary beam at the distance from any passengers) is exposed to the primary beam,
the beam exit surface where the surface the provisions of ANSI N43.17 shall be followed
of the vehicle being screened would be in determining the potential dose to these
located during normal operation. individuals.
26
ANSI/HPS N43.16-2021
A scatter object consisting of three stackable 5 equivalent on the order of 10 μSv (1 mrem) or
gallon plastic containers filled with water. less.
2. Position a target vehicle for screening 1. Position the screening system on a level
and place the three water containers in a surface.
vertical stack in the cargo area of the
vehicle directly behind the driver’s 2. Position a target vehicle for screening
position in the cab as close to the driver and place the three water containers in a
as possible. vertical stack in the cargo area about 30
cm from the side closest to the radiation
3. Place the ionization chamber at the source. Ensure the water containers are
location of the driver’s head (this is sufficiently secured to remain in place
usually the least shielded location on the during the screening process.
driver’s body). Place the ionization
chamber in an integrate or accumulate 3. Position the ionization chamber between
mode. the water containers and the side of the
cargo container nearest the radiation
4. Perform 10 screenings of the vehicle source and as close to the water
without resetting the ionization chamber. containers as possible. Place the
Record the total ambient dose equivalent ionization chamber in an integrate or
for the ten screenings. accumulate mode.
5. Divide the total ambient dose equivalent 4. Perform 10 screenings of the vehicle
by 10 to obtain the average dose per without resetting the ionization chamber.
screening to the driver. Record the total ambient dose equivalent
for the ten screenings.
For instruments calibrated in exposure units (i.e.,
roentgen), the radiation protection assumption 5. Divide the total ambient dose equivalent
that an exposure of 1 R is equivalent to an by 10 to obtain the average dose per
ambient dose equivalent of 0.01 Sv (1 rem) may screening to the driver.
be used.
For instruments calibrated in exposure units (i.e.,
C.4. Dose to an Inadvertently Scanned roentgen), the radiation protection assumption
Individual that an exposure of 1 R is equivalent to an
ambient dose equivalent of 0.01 Sv (1 rem) may
This measurement is used to demonstrate be used.
compliance with the dose limit for an inadvertently
scanned individual specified in section 5.3. It is C.5. Boundary of the Radiation Control Area
also an estimate of the dose to cargo, which may
be of interest in cases where radiation sensitive Manufacturer’s shall also determine the
cargo needs to be screened. dimensions of the radiation control area using the
procedures in Annex D. This determination shall
C.4.1 Equipment Required be made using the parameters that maximize the
size of the operational area (e.g., the combination
An ionization chamber or dosimeter capable of of number of screenings per hour and scan speed
measuring an accumulated ambient dose that results in the largest total beam-on time per
hour).
27
ANSI/HPS N43.16-2021
to the facility and make, on average, two visits to ground and set it to an integrated
the facility per day. measurement mode.
In this scenario, both the dose to the system 3. Perform 1-10 screenings of a typical
operators and the vehicle drivers needs to be vehicle or cargo container. (The number
considered and different dose limits are applied of screenings needed will depend on the
to each. For the system operators, the dose per sensitivity of the instrument and the
screening at boundary cannot exceed maximum dose per screen determined
using the methodology above. The
5mSv/y minimum measurable dose divided by
6 d⁄wk × 50 wk⁄y × 100 screenings⁄d the number of screenings must be less
= 1.7 × 10#$ mSv (0.17 µSv) than the maximum allowable dose per
screening.)
A more conservative value would be obtained if
constant operation at the maximum number 4. Repeat steps 2 and 3 at several locations
screenings per hour was assumed. around the boundary of the radiation
control area.
For the vehicle drivers, the maximally exposed
driver is expected to be present for only two 5. Divide each of the measured values by
screenings per day. In this case, the dose limit for the number screenings performed for
the general public is used and the maximum dose each measurement to get the average
per screening is dose per screening. This value must be
less than the maximum allowable dose
1 mSv⁄y per screening at each location.
6 d⁄wk × 50 wk⁄y × 2 screenings⁄d
= 1.7 × 10#% mSv (1.7 µSv) 6. If any measured values exceed the
maximum allowable dose per screening,
Because the maximum dose per screening for the increase the dimensions of the radiation
system operators is the lowest, that value should control zone and repeat the
be used as the basis for establishing the radiation measurements.
control area boundary.
Alternatively, measurements can be made at
D.4 Radiation Control Area Survey designated grid locations around the system and
the appropriate dimensions determined by the
D.4.1 Equipment Required grid points at which the average dose per
screening is acceptable.
An ionization chamber or other instrument
calibrated for dose measurements at the
appropriate photon energy. Ideally, the
instrument should be capable of measuring an
integrated dose of 0.01 μSv (1 μrem) or less.
D.4.2 Procedure