Radiation-Generating Devices - Entire Document (Very Large)
G-10 CFR 835/C3 - Rev. 1
NOVEMBER 1994
IMPLEMENTATION GUIDE
For Use With Title 10, Code of Federal Regulations, Part 835
OCCUPATIONAL RADIATION PROTECTION
RADIATION-GENERATING DEVICES
ASSISTANT SECRETARY for ENVIRONMENT, SAFETY and HEALTH
FINAL GUIDE - FOR UNLIMITED USE and DISTRIBUTION
U.S. Department of Energy IMPLEMENTATION GUIDE
G-10 CFR 835/C3 - Rev. 1
RADIATION-GENERATING DEVICES
CONTENTS Page
I. PURPOSE AND APPLICABILITY. . . . . . . . . . . . . . . . . 1
II. DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . 2
III. DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . 5
IV. IMPLEMENTATION GUIDANCE . . . . . . . . . . . . . . . . . . 7
A. Administrative Organization and Controls . . . . . . . . 8
1. Contractor Management . . . . . . . . . . . . . . . . 8
2. RGD Custodian . . . . . . . . . . . . . . . . . . . . 9
3. RGD Operator. . . . . . . . . . . . . . . . . . . . . 10
4. Qualified Expert. . . . . . . . . . . . . . . . . . . 10
5. Radiation Protection Manager. . . . . . . . . . . . . 11
6. Radiation Protection Organization . . . . . . . . . . 12
B. Development of Site-Specific Documents . . . . . . . . . 12
1. Responsible Individuals . . . . . . . . . . . . . . . 13
2. RGD Installation Design . . . . . . . . . . . . . . . 13
3. RGD Procurement . . . . . . . . . . . . . . . . . . . 14
4. Design Review and Approval. . . . . . . . . . . . . . 15
5. Normal Operations . . . . . . . . . . . . . . . . . . 15
6. Off-Normal Operations . . . . . . . . . . . . . . . . 17
7. Maintenance . . . . . . . . . . . . . . . . . . . . . 18
8. RGD Decommissioning . . . . . . . . . . . . . . . . . 19
C. Implementation of Site-Specific Documents. . . . . . . . 19
1. Pre-Operational Inspections . . . . . . . . . . . . . 19
2. Pre-Operational Radiation Surveys . . . . . . . . . . 21
3. Periodic Inspections and Radiation Surveys. . . . . . 21
4. Radiation Survey Report . . . . . . . . . . . . . . . 23
5. Sealed Radioactive Source Leak Testing. . . . . . . . 23
6. Area Posting. . . . . . . . . . . . . . . . . . . . . 23
7. Labeling. . . . . . . . . . . . . . . . . . . . . . . 25
8. Training. . . . . . . . . . . . . . . . . . . . . . . 26
9. Records . . . . . . . . . . . . . . . . . . . . . . . 28
D. Engineered Safety Controls . . . . . . . . . . . . . . . 31
1. Shielding, Controls, & Safety Devices . . . . . . . . 31
2. Requirements for Specific RGD Installations . . . . . 35
V. REFERENCES. . . . . . . . . . . . . . . . . . . . . . . . . 39
VI. SUPPORTING DOCUMENTS. . . . . . . . . . . . . . . . . . . . 41
VII. APPENDICES
APPENDIX A
10 CFR 835, Implementation Guide, and DOE Radiological
Control Manual Cross-Reference. . . . . . . . . . . . . 44
APPENDIX B
Inspection & Survey Frequencies for Routine Operations. 47
Section I - Purpose and Applicability
I. PURPOSE AND APPLICABILITY
This Implementation Guide (IG) provides an acceptable methodology for
establishing and operating a radiation-generating devices (RGD) control
program that will comply with U.S. Department of Energy (DOE)
requirements specified in Title 10 of the Code of Federal Regulations
(CFR), Part 835, "Occupational Radiation Protection" (DOE, 1993a;
hereinafter referred to as 10 CFR 835). For completeness, this IG also
identifies applicable requirements and recommendations contained in DOE
Order 5480.11, as amended, "Radiation Protection for Occupational Workers"
(DOE, 1992a); DOE Order 5700.6C, "Quality Assurance" (DOE, 1991a); DOE
Order 5480.4, "Environmental Protection, Safety, and Health Protection
Standards" (DOE, 1984); DOE's "Radiological Control Manual" (DOE, 1994a;
hereinafter referred to as the RCM)(with the associated numbers denoting
the article numbers); and secondary documents (American National
Standards Institute (ANSI) Standards, etc.) invoked by the above
documents. Appendix A of this IG provides a cross-reference of the
applicable material from 10 CFR 835, this IG, and the RCM.
This IG amplifies the regulatory requirements of 10 CFR 835, which are
enforceable under the provisions of Sections 223(c) and 234A of the
Atomic Energy Act of 1954, as amended (AEC, 1954). The requirements and
recommendations of the other DOE documents are enforceable through
contractual or administrative means.
The IG also provides guidance for the structure, function, and
operations of a radiation-generating devices control program.
Except for requirements mandated by a regulation, a contract, or by
administrative means, the provisions in this IG are DOE's views on
acceptable methods of program implementation and are not mandatory.
Conformance with this IG will, however, create an inference of
compliance with the related regulatory requirements. Alternate methods
that are demonstrated to provide an equivalent or better level of
protection are acceptable. Contractors are encouraged to go beyond the
minimum requirements and to pursue excellence in their programs.
The word "shall" is used in this IG to designate requirements from 10
CFR 835, DOE Orders, the RCM, and secondary documents invoked by them.
The requirements of 10 CFR 835 are mandatory except to the extent an
exemption has been granted pursuant to 10 CFR 820, "Procedural Rules for
DOE Nuclear Activities" (DOE, 1993b) and are identified by a bolded and
underlined "shall." Requirements taken from DOE Orders and the RCM are
mandatory to the extent they are invoked by a contract or through
administrative means.
Those facilities not subject to the requirements of 10 CFR 835 should
substitute the corresponding DOE 5480.11 requirements.
This IG is applicable to all DOE activities involving occupational
exposure to ionizing radiation of DOE employees and/or
DOE-contractor/subcontractor employees.
Section II - Definitions
II. DEFINITIONS
accessible surface: Any surface to which access by any part of the
human body is possible without the use of tools or without the removal
of any part of the device.
as low as reasonably achievable (ALARA): The "approach" to radiation
protection to manage and control exposures (both individual and
collective) to the work force and to the general public to levels as low
as is reasonable, taking into account social, technical, economic,
practical, and public policy considerations. "ALARA is not a dose limit
but a process" which has the objective of attaining doses as far below
the applicable limits of 10 CFR 835 as is reasonably achievable.
attenuation: The reduction of the quantity of ionizing radiation upon
passage through matter, resulting from all types of interactions with
that matter.
cabinet X-ray system: An X-ray system with the X-ray tube installed in
an enclosure (hereinafter termed "cabinet") which, independently of
existing architectural structures except the floor on which it may be
placed, is intended to contain at least that portion of a material being
irradiated, provide radiation attenuation, and exclude individuals from
its interior during generation of X-radiation. Included are all the
X-ray systems designed primarily for inspection of carry-on baggage at
airline, railroad, and bus terminals, and in similar facilities. An
X-ray tube used within a shielded part of a building or X-ray equipment
which may temporarily or occasionally incorporate portable shielding is
not considered a cabinet X-ray system.
controlled area: Any area to which access is managed in order to
protect individuals from exposure to radiation and/or radioactive
material.
entrance or access point: Any location through which an individual
could gain access, in whole or in part, to areas controlled for the
purposes of radiation protection. This includes entry or exit portals
of sufficient size to permit human entry, irrespective of their intended
use.
fail-safe design: Despite any failure of equipment indicator or safety
components that can reasonably and realistically be anticipated, the
device is designed to protect individuals from exposure to radiation.
For example, if a light indicating "X-RAY ON" fails, the production of
X-rays will be prevented; or if a shutter status indicator fails, the
shutter will close.
flash X-ray unit: Any device that is capable of generating pulsed
X-rays.
interlock: A device for precluding access to an area of radiation
hazard by either preventing entry or by automatically removing the
hazard. One example is an electro-mechanical control mechanism that
interrupts the beam of ionizing radiation or shuts down the radiation
installation whenever the interlock is challenged.
irradiator: Any sealed radioactive material that has the potential to
create a radiation level exceeding 500 rads (5 grays) in 1 hour at 1
meter. As used in this IG, any sealed radioactive source operated
within the requirements of an RGD installation.
leakage radiation: All radiation, except the useful beam, coming from
the X-ray assembly or sealed radioactive source housing.
modification: Any alteration of the shielding configuration, device or
installation operating practices, or the replacement of the original RGD
(or component part thereof) with another that has not been previously
evaluated, inspected, surveyed, and documented by the Radiation
Protection Organization. This definition also includes the collocation
of additional or multiple unevaluated RGDs within a previously evaluated
installation.
normal operation: Operation under conditions as recommended by the
manufacturer of the RGD with recommended shielding and barriers in
place, and as specified in the operating procedures and requirements for
the RGD installation.
occupancy factor: Used during shielding design and analyses, the time
factor by which the workload or the dose or dose-rate should be
multiplied to correct for the degree of human habitability of the area
in question while the RGD is producing radiation.
occupied (occupiable) area: An area or location that may be physically
accessible by individuals (or body parts thereof) while a
radiation-generating device is in operation.
off-normal operation: An event or condition that adversely affects,
potentially affects, or indicates degradation in the safety, security,
environmental, or health-protection performance or operation of an RGD
installation. An "off-normal" event requires reporting in accordance
with DOE 5000.3B, "Occurrence Reporting and Processing of Operational
Information" (DOE, 1993c).
qualified expert: An individual having the knowledge, training, and
recognition of such by management to measure ionizing radiation, to
evaluate safety techniques, to design RGD installations, and to provide
advice on radiation protection requirements.
quality assurance: Actions that provide confidence that quality is
achieved. As used in this guide, the planned and systematic actions
necessary to provide adequate confidence that an installation or
component thereof will perform satisfactorily in service and in
compliance with DOE requirements.
radiation-generating device (RGD): Collective term for devices which
produce ionizing radiation, sealed sources which emit ionizing
radiation, small particle accelerators used for single purpose
applications which produce ionizing radiation (e.g., radiography), and
electron generating devices that produce X-rays incidentally.
radiography: Examination of the structure of materials by nondestructive
methods, using a RGD.
RGD Custodian: An individual who is trained and designated to maintain
cognizance over accountability and control of radiation-generating
devices assigned to him or her.
RGD installation: The sum of the radiation source (e.g., sealed
radioactive material or x-ray tube), the associated equipment and
component items, and the space in which they are located.
Four types of installations are defined as follows:
(1) exempt shielded installations are those designed to fully enclose
the specimen to be irradiated and to provide adequate shielding to
meet 10 CFR 835.1002(b);
(2) shielded installations are those designed to use the
room-within-a-room concept to limit access to the RGD beam and to
place more emphasis on distance as opposed to shielding for
radiation protection;
(3) open installations are those designed to accommodate a specimen
that is so large as to make an exempt shielded installation
impractical; and
(4) unattended installations are those designed for a specific purpose
and that do not require personnel in attendance for operation.
RGD Operator: An individual who is trained and deemed qualified by the
radiation protection organization and the RGD Custodian to use a
radiation-generating device.
sealed radioactive source: Any radioactive material that is contained
in a sealed capsule, sealed between layers of nonradioactive material,
or firmly fixed to a nonradioactive surface by electroplating or other
means. The confining barrier prevents dispersion of the radioactive
material under normal and most accidental conditions related to the use
of the source. For purposes of categorizing a sealed source as a RGD,
the radiation intensity of the unshielded source must equal or exceed
100 mrems (1 mSv) in 1 hour when measured at 30 centimeters from the
source.
shall: Within the context of this Guide, the word "shall" is used to
designate requirements from 10 CFR 835, the RCM, DOE Orders, and
secondary documents invoked by them.
shielding barrier: Any barrier of attenuating material used to reduce
radiation hazards. Used collectively as "shielding."
shielding barrier, primary: Any barrier sufficient to attenuate the
useful beam to the required radiation level.
shielding barrier, secondary: Any barrier sufficient to attenuate
leakage or scattered radiation to the required radiation level.
should and may: Within the context of this Guide, the words "should"
and "may" are used to represent optional program recommendations and
allowable alternatives, respectively. Deviations generally require no
specific approval or justification; however exceptions or deviations to
"should" provisions referenced directly from the RCM require specific
justification and approval in accordance with Article 113.3 of that
manual(i.e. RCM 113.3).
survey: An evaluation of the radiological conditions and potential
hazards incident to the production, use, transfer, release, disposal, or
presence of radioactive material or other sources of radiation. When
appropriate, such an evaluation includes a physical survey of the
location of radioactive material and measurements or calculations of
levels of radiation, or concentrations or quantities of radioactive
material present.
useful beam: That part of the primary and secondary radiation beam that
passes through the aperture, cone, or other device used for collimation.
workload: Used during the design of RGD shielding, a measure of the
intended amount of RGD use expressed in units of the output of the RDG
integrated over time; for example, milliampere-minutes per week for
X-ray generating devices operating below 4 MeV.
Section III - Discussion
III. DISCUSSION
10 CFR 835.202 requires, in part, that occupational exposures to
radiation "shall" be controlled so as not to exceed specified annual
limits. In addition, 10 CFR 835 requires that:
'Measures "shall" be taken to maintain radiation exposure in controlled
areas as low as is reasonably achievable through facility and equipment
design and administrative control. The primary methods used shall be
physical design features (e.g., confinement, ventilation, remote
handling, and shielding). Administrative controls and procedural
requirements "shall" be employed only as supplemental methods to control
radiation exposure' (10 CFR 835.1001(a)).
10 CFR 835.101 requires that: 'a DOE activity "shall" be conducted in
compliance with a documented radiation protection program (RPP)...", and
that "the content of each RPP "shall" be commensurate with the nature of
the activities performed and "shall" include formal plans and measures for
applying the as low as reasonably achievable (ALARA) process to
occupational exposure'.
10 CFR 835, the RCM, and DOE Orders, by necessity, must be generic to
cover the wide spectrum of facilities and activities within the DOE
complex. These primary documents often embrace and invoke the concepts,
requirements, and recommendations of secondary documents.
For the RGD program area the following documents have been invoked by
either DOE Order 5480.4, as amended, or the RCM:
-- 10 CFR 34, "Licenses for Radiography and Radiation Safety
Requirements for Radiographic Operations" (NRC, 1992);
-- ANSI N43.3, "American National Standard For General Radiation
Safety - Installations Using Non-Medical X-Ray and Sealed
Gamma-Ray Sources, Energies Up to 10 MeV" (Which updates ANSI
N543-1974) (ANSI, 1993);
-- ANSI N43.2, "Radiation Safety for X-Ray Diffraction and
Fluorescence Analysis Equipment" (ANSI, 1989a); and
-- ANSI N43.5, "Radiological Safety Standard for the Design of
Radiographic and Fluoroscopic Industrial X-Ray Equipment"
(Formerly called N537) (ANSI, 1989b).
When appropriate, these standards are cited with the specific section of
the standard enclosed in parentheses.
Requirements are defined in this IG for:
-- Radiation-generating devices;
-- analytical X-ray devices;
-- small accelerators used for radiography or other single
purpose applications;
-- radiation or electron generating devices that produce X-rays
incidentally;
-- sealed gamma-ray sources; and
-- sealed neutron sources.
Specific examples include: sealed photon or neutron emitting radioactive
sources; X-ray producing radiography equipment; research and analytical
X-ray or electron beam machines; sealed radioactive sources used as
irradiators; particle accelerators; neutron generators; Van de Graff
generators; electromagnetic pulse generators (if capable of producing
ionizing radiation); electron microscopes; electron arc welders;
microwave cavities that produce X-rays incidentally, and cabinet X-ray
machines used for security applications.
In general, all RGDs addressed may be classified as either devices that
must be electrically energized to produce ionizing radiation or sealed
radioactive sources consisting of encapsulated isotopes that emit
radiation continuously.
RGDs are used at DOE sites with a great variety of configurations and
operating characteristics and in a wide spectrum of applications. This
IG addresses RGDs used for industrial and research applications. RGDs
used for patient diagnostic or therapeutic medical applications are not
addressed. RCM 365.4 requires that medical RGDs be registered with the
cognizant regulatory agency which typically is a Federal, state or local
level authority. Requirements for medical uses are provided in DOE Order
5480.8A, as amended, "Contractor Occupational Medical Program" (DOE,
1992b).
To ensure individual safety from radiation, RGDs used at DOE sites
should be operated within an exempt shielded enclosure or installation.
These installations protect individuals by providing physical shielding
and/or controlling access to areas where RGDs are operated. All new RGD
installation designs and the modification of old RGD installations "shall"
consider radiological protection in their design objectives (10 CFR
835.1002 and RCM 128). Further guidance is provided in Section IV.B.2.,
"RGD Installation Design," of this IG.
Each installation provides different degrees of radiation protection. In
exempt shielded (including cabinet X-ray systems), shielded, and unattended
RGD installations, radiation protection is ensured primarily through the
use of physical barriers that include shielding and access controls.
Administrative controls are used in addition to physical controls to
prevent access to the RGD and controlled radiation areas during operation,
i.e., during beam activation or beam exposure.
Open installations, or "open air" installations, are used when the
specimen to be irradiated is too large for a shielded installation, when
a temporary setup is required, or when other operational constraints do
not permit using the RGD within a permanent enclosure. For open
installations, radiation protection is ensured primarily by the use of
posted perimeters, distance from the source to working individuals, and
continuous surveillance.
Analytical devices that are used for X-ray diffraction (typically low
energy) and fluorescence research applications are a subclass of either
exempt shielded or shielded installations. Analytical devices may use
either an open or shielded X-ray beam configuration. In the open-beam
systems, beam shutters, interlocks, distance, and shielding are used to
prevent radiation exposure above DOE mandated limits. In shielded
systems, the radiation source, sample, and detector (where needed) are
shielded in single or coupled enclosures that cannot be breached during
normal operations.
Small accelerators are also operated either within shielded enclosures
or "open air" configurations. Radiation protection requirements are
therefore similar to those designed for an RGD with a similar hazard.
RGDs that are commercially available, such as electron microscopes,
electron arc welders, industrial sources such as those used in density
and level gauges, and cabinet X-ray machines used for security
applications, "shall" be procured, categorized, inventoried, operated,
inspected and surveyed to ensure compliance with 10 CFR 835.1001 and
1003.
Section IV - Introduction
IV. IMPLEMENTATION GUIDANCE
Design and operation of RGD installations "shall" be conducted in
compliance with the site-specific radiation protection program (RPP)(10
CFR 835.101(a)) and the site-specific RCM (RCM 114). The requirements
and guidance for RGDs included in the RPP and RCM "shall" be commensurate
with the nature of activities performed and include formal plans and
measures for maintaining occupational radiation exposures ALARA (10 CFR
835.101(a) & (c) and RCM 114 & 128).
This Section identifies the: (1) administrative organization and
controls required for developing and implementing RPP and RCM
requirements; (2) elements that "shall" be included in the RPP (10 CFR
835.101(e) & (f)) and RCM to ensure effective administrative and
radiological controls for RGD design and operations; (3) RGD related
requirements for implementation of the site-specific RPP and RCM; and
(4) RGD engineered safety controls (RCM 114).
During any operation, the combination of design features and
administrative controls "shall" be implemented (10 CFR 835.1003(a) and RCM
213.1) to ensure that:
-- The anticipated magnitude of the total effective dose equivalent
"shall" not exceed 5 rems (0.05 sievert) in a year;
-- the anticipated magnitude of the committed dose equivalent to any
organ or tissue (including the skin), plus any deep dose equivalent
from external exposure, "shall" not exceed 50 rems (0.5 sievert) in a
year; and
-- exposure levels are as low as reasonably achievable.
Section IV, Subsection A - Administrative Organization and Controls
A. Administrative Organization and Controls
RGD control is maintained by individuals responsible for RGD operations.
Overview for radiological safety is provided by the independent
radiation protection organization. At some DOE sites, this organization
is referred to as the health physics group or the radiation protection
group. This organization includes the radiation protection manager and
the radiation protection staff as essential constituents (RCM 141-144).
Among the larger DOE sites, where numerous RGDs are used for a number of
applications, sufficient operational and radiation protection staff are
usually available for the positions described. At smaller DOE sites,
where fewer administrative or operational and radiation protection staff
are available, certain positions may overlap. Thus, a radiation
protection manager may review survey results and also conduct the
surveys as a radiation protection staff member. The radiation
protection manager could also serve as the qualified expert. Similarly,
RGD Custodians may also function as RGD Operators. However, no matter
how small the site or facility, the independent role of the radiation
protection staff should be maintained to ensure the implementation and
the quality of the radiation protection program (RCM 141.1).
1. Contractor Management
Managers responsible for RGD installations provide leadership in
administrative and operational control as outlined in RCM 114, 142, and
344. They provide guidance and approval for RGD design, modification,
control, and operation, as well as procurement and decommissioning of
RGDs and RGD installations.
The Secretary of Energy Memorandum "Environment, Safety and Health
Policy for the Department of Energy Complex", (DOE, 1993d) dated July
20, 1993, and the Department of Energy Notice DOE N 5480.8, "Radiological
Health and Safety Policy" (DOE, 1993e) establish the precept that line
management is accountable and responsible for the safe operations of
their programs and activities.
To implement this responsibility, management performs the following
tasks:
-- Appoints a RGD Custodian for each RGD installation;
-- exercises supervision to ensure that RGDs are operated safely;
-- reviews RGD installation procedures, and both the operational and
maintenance logs;
-- schedules periodic inspections and surveys to ensure that RGDs are
maintained in a safe condition;
-- approves operating and emergency procedures;
-- schedules and otherwise provides for training to ensure that RGD
Custodians and RGD Operators are trained and re-certified in
accordance with the RCM (Chapter 6, Part 5) and that the topics
delineated in Section IV.C.8, "Training", of this IG are covered for
the site-specific instruction; and
-- promptly terminates the operation of any unsafe RGD installation.
2. RGD Custodian
A RGD Custodian should be designated by management to provide direct
control over RGD installations and operations. The RGD Custodian
ensures that the RGD installation is operated and maintained safely and
in accordance with the requirements of the site-specific RPP, the
site-specific RCM, and this IG. Specific responsibilities of the RGD
Custodian should include the following:
-- Controlling the keys to RGD installations, RGDs, and/or RGD storage
facilities and authorizing the operation of the RGD installation
(RCM 334.7);
-- ensuring that applicable operating procedures are followed by all
RGD operators;
-- ensuring that the applicable Radiological Work Permit (RWP), or
alternative authorization, is followed by all RGD Operators;
-- ensuring that required dosimeters are issued and properly worn;
-- ensuring that inspections of RGD interlocks, warning lights, and
other safety features are performed and documented in accordance
with Appendix B of this IG;
-- ensuring that all surveys are performed and documented in
accordance with Appendix B of this IG;
-- ensuring that all RGD Operators are trained;
-- reviewing and approving materials used for training, in cooperation
with the radiation protection staff;
-- maintaining accountability records of assigned RGDs independent of
other lists;
-- notifying the radiation protection staff of changes in shielding
configuration, use, storage, disposal, or loss of an RGD;
-- ensuring that sealed radioactive source integrity tests are
performed; and
-- maintaining schematics (mechanical and electrical), safety device
wiring diagrams, manufacturer provided instruction manuals, and
operations and maintenance records.
3. RGD Operator
RGD Operators are those individuals authorized by the RGD Custodian to
use the RGD. The RGD Operator ensures that RGD operations are conducted
in accordance with the requirements of the site-specific RGD procedures.
The RGD Operator:
-- Ensures proper control of the RGD installation and/or area;
-- ensures that inspections and surveys are performed and documented;
-- ensures that required dosimeters are worn properly by all
individuals in the vicinity of RGD operations;
-- follows the applicable RWP, or alternative authorization, and
ensures that other individuals also adhere to the requirements of
those documents;
-- establishes control of all adjacent areas where individuals could
receive a dose approaching administrative limits;
-- ensures that those areas are unoccupied during RGD operations;
-- maintains access control over the actual RGD exposure area;
-- follows all applicable operating procedures; and
-- promptly terminates unsafe RGD operations.
4. Qualified Expert
A qualified expert(s) should be appointed by management to implement 10
CFR 835.501(d), DOE 5700.6c (Criterion 6) and ANSI N43.3(6.1). To
ensure technical qualification, the qualified expert should be approved
by the radiation protection manager. The qualified expert shall have
knowledge and training necessary to: (1) measure ionizing radiations;
(2) analyze the significance and evaluate the potential health effects
of survey results; and (3) to advise on matters related to radiation
protection as it pertains to installations covered by this IG (ANSI
N43.3(3.25)). The qualified expert should have in-depth knowledge of
characteristics associated with RGDs, RGD installations, and applicable
Rules, Manuals, Orders, and Standards.
The qualified expert should review the following areas and provide
recommendations to the radiation protection manager:
-- The design or modification of RGD installations;
-- the results of pre-operational inspections and radiological
surveys;
-- the engineered safety features and administrative controls;
-- the need for and adequacy of the personnel monitoring program for
the installation, including verification of use of DOELAP certified
dosimeters; and
-- the training materials used for the RGD Custodians and Operators.
5. Radiation Protection Manager
A radiation protection manager should be designated for each DOE site to
ensure independent overview of radiological operations, including RGDs
(RCM 141 & 142). The radiation protection manager's function is similar
to that of the radiological protection supervisor or radiation
protection officer, as described in the specific ANSI standards
referenced in this IG and publications of the National Council on
Radiation Protection and Measurements (NCRP).
The radiation protection manager heads the radiation protection
organization and is specifically responsible for radiation safety in
conjunction with management (RCM 141.3). It is the responsibility of the
radiation protection manager to ensure that all procedures for RGDs are
carried out in compliance with the requirements of the site-specific RPP
and RCM, and guidance provided in this document.
In order to implement these responsibilities, the radiation protection
manager or designated alternate (RCM 141 & 142 and ANSI N43.3(9.1)):
-- Provides oversight for the establishment and implementation of the
RPP and RCM for the site (RCM 141.3);
-- ensures that RGD operating procedures are current and available at
each RGD installation for both normal and off-normal operations
(ANSI N43.3(9.1.1));
-- ensures that pre-operational inspections and surveys are performed,
that a pre-operational assessment has been performed by a qualified
expert, and that recommendations on the RGD installation have been
received from the qualified expert and have been resolved (ANSI
N43.3(9.1.1));
-- assures that safety devices and interlocks are functioning and
located where required and that independent radiation surveys are
performed by members of the radiation protection staff to verify
this (ANSI N43.3(9.1.4));
-- maintains a current inventory of all RGDs independent of other
inventories (ANSI N43.3(9.1.1));
-- reviews and provides written approval of inspection and radiation
survey results and advises line management of the need for
corrective action where applicable, including shutdown of unsafe
installations (ANSI N43.3(9.1.1));
-- in the absence of timely line management response, terminates
unsafe RGD operations (RCM 345.1);
-- approves resumption of operations in conjunction with line
management (RCM 345.4);
-- approves the RGD Custodian (ANSI N43.3(9.1.1));
-- approves the by-passing of any safety device (ANSI N43.3(9.1.4));
-- approves any deviation from established procedures (ANSI
N43.3(9.1.1));
-- requires and approves a RWP or alternative authorization associated
with the operation of a RGD (ANSI N43.3(9.1.1) and RCM 323.2);
-- assures that all individuals are instructed in safe working
practices and the nature of injuries resulting from overexposures
to RGDs (ANSI N43.3(9.1.2)); and
-- investigates any incident of abnormal exposure or suspected
overexposure of an individual to determine the cause and to
initiate remedial action (ANSI N43.3(9.1.3)).
6. Radiation Protection Organization
The radiation protection organization (RPO) at the site provides support to
managers and radiological workers. The radiation protection staff consists
of the radiation protection manager, radiological control technicians
(RCTs) and other technical and administrative staff. To function
effectively, the radiation protection staff should be independent of the
site line organizations and should be accountable to the radiation
protection manager (RCM 141).
Radiation protection staff perform the following tasks in order to
implement their functions described in the RCM (RCM 141.2 and 143.2):
-- Evaluate adherence to the site-specific RPP and the RCM by
conducting pre-operational and periodic inspections and radiation
surveys of RGD installations as specified in Section IV.C.3.,
"Periodic Inspections and Radiation Surveys of this IG" (RCM 551);
-- under the direction of the radiation protection manager, provide
radiological support to line managers and RGD operations (RCM
141.2);
-- ensure that all inspections and surveys are performed and
documented in accordance with Appendix B of this IG;
-- perform radiation surveys of open installations to verify proper
posting and control of boundaries during operations and removal of
hazards (and associated temporary postings and barriers) after
operations (10 CFR 835.401(a) & (b));
-- monitor all RGD installations for potential or actual unsafe
operations or conditions and conformity to the site-specific RPP
and RCM (10 CFR 835.1001(a) & (b) and RCM 141.2); and
-- review the operational and maintenance logs maintained by RGD
Custodians and Operators to ensure that controls are commensurate
with existing or potential radiological hazards (10 CFR 835.501(b)
& (d)).
Section IV, Subsection B - Development of Site-Specific Documents
B. Development of Site-Specific Documents
DOE activities "shall" be conducted in conformance with an approved
site-specific RPP (10 CFR 835.101(a)) and site-specific RCM (RCM 114.1).
The site-specific RPP should include adequate procedures that address
RGD design and operation, including off-normal and emergency operations.
The qualified expert should review, and the radiation protection staff
should overview and approve the site-specific RCM and procedures (RCM
141, 346, and 365).
Essential elements of the approved site-specific RPP, RCM, and
procedures are addressed in this Section.
1. Responsible Individuals
The procedures should include a clear description of management
responsibilities for implementing and periodically updating the
site-specific RCM and RGD procedures.
2. RGD Installation Design
The selection of the type of RGD installation and its design basis is
usually dictated by the specific application for which RGDs are used.
The design basis should adequately document the methods used to address
all DOE mandated requirements (DOE 5700.6C (Criteria 4 and 6)).
During the design of new facilities or the modification of old
facilities, the following design objectives "shall" (10 CFR 835.1002(a) &
(b)) be adopted:
-- Use of optimization methods to assure that occupational exposure is
maintained ALARA in developing and justifying RGD installation
design and physical controls;
-- control of individual exposure from external sources of radiation
in areas of continuous occupancy to maintain exposure levels below
an average of 0.5 mrem per hour (5 ęSv/hr) and as far below this
average as is reasonably achievable; and
-- control of potential exposure to a radiological worker where
occupancy differs from the above condition, to maintain exposure
rates ALARA and to not exceed 20 percent of the applicable
standards in 10 CFR 835.202.
ANSI standards specify exposure limits (at various distances) for outdoor
applications and RGD installations. Only the exposure limits for exempt
shielded, cabinet, and shielded beam analytical X-ray diffraction type RGD
installations comply with 10 CFR 835.1002. To ensure that 10 CFR 835
requirements are met for all RGD installations (except open), shielding
"shall" be provided for any new or modified RGD installation to ensure that
radiation levels outside (occupiable by a person) the RGD installations do
not exceed either 0.5 mrem/hr (5 micro-Sv/hr) or 20% of the applicable
standards in 10 CFR 835.202, and are ALARA (10 CFR 835.1001(a) & 1002(b),
and RCM 128.1a & 311). The requirement also implies that both continuous
and non-continuous (pulsed) radiation shall be considered. Thus, any
design must consider the greater value of either the dose rate limit or the
corresponding integrated dose over a specified time period to demonstrate
compliance with the design objectives.
Existing installations that do not meet the 10 CFR 835 requirements
should be evaluated and designed so that compliance is achieved
primarily by shielding. If this is determined to be inappropriate due
to a physical (e.g., space or weight loading) or other justifiable
limitation, then a combination of design features and administrative
controls (which limit occupancy or control access to the beam) "shall" (10
CFR 835.1001(b) and RCM 311) be implemented. RCM 128.1(a) specifies
that design considerations should be ALARA and result in less than 500
mrem/yr (5 mSv/yr) to a worker. Assuming continuous occupation (2000
hours per year), to meet this, the dose rate from a continuously
produced radiation field should not exceed 0.25 mrem/hr (2.5 ęSv/hr).
In addition, Table 2-1 of the RCM and 10 CFR 835.207 & 208 limit the
dose to minors, visitors, and members of the public to 100 mrem (1 mSv)
per year. Thus, if these individuals could occupy areas in the vicinity
of the RGD installation, this criterion "shall" predominate for design
considerations which rely on shielding only to comply with 10 CFR
835.207 & 208. However, 10 CFR 835.1003(a) permits the combination of
design features and administrative controls. If the 100 mrem (1 mSv)
limit can not be achieved by shielding alone, administrative controls
must be implemented. An example of such a control would be time
limitation or prohibition of RGD use when members of the public or
visitors are present. For neutron-generating devices, a quality factor
of 20 should be used for design purposes (RCM 128.1(g)).
Design protocols should, as a minimum, reference ANSI N43.3, N43.2, and
N43.5 and "shall" be in compliance with the site-specific RPP (10 CFR
835.101) and site-specific RCM (RCM 114). The ANSI standards include
requirements for exempt shielded, shielded, unattended, and open RGD
installations. Requirements for analytical installations are identified
in ANSI N43.2. Specific requirements for each type of installation are
described in ANSI N43.3 and N43.2.
The design or modification of an RGD installation and the selection of
RGDs and materials "shall" include features that facilitate maintenance,
decontamination, and decommissioning (10 CFR 835.1002(d) and RCM 312).
This should include the consideration of alternative materials to lead
for shielding, where practical.
3. RGD Procurement
To ensure that the RGD installation meets DOE standards, procedures
should include procurement requirements for RGDs and materials used in
the construction of the installation to meet the requirements of 10 CFR
835.501(d) and DOE 5700.6C (Criterion 7). Procedures for RGD
installations should identify individuals responsible for procurement as
follows:
-- Cognizant management responsible for notifying the site radiation
protection staff and the Quality Assurance Organization (QAO), if
required by a site implementation plan, of the intent to procure a
RGD and the installation design; and
-- the radiation protection staff and the QAO who review and provide
assistance in the development of:
- appropriate specifications and radiological control
requirements for the proposed device; and
- the general provisions that are required to be provided
to the purchaser (i.e., DOE or contractor) pursuant to 21
CFR Chapter I, Subchapter J , Part 1000, Subparts A and
B; Part 1003.10(b)(2); Part 1004.1; and Part
1020.40(c)(9) & (10) (HHS, 1992) and DOE 5700.6C
(Criterion 7), if the RGD is purchased as a commercially
available electronic or X-ray product.
4. Design Review and Approval
Procedures shall include instructions to comply with the design
requirements of DOE 5700.6C (Criterion 6) and for reviews of technical
drawings and wiring diagrams. The proposed design should be reviewed for
compliance with ANSI N43.3, ANSI N43.2, and ANSI N43.5. The radiation
protection staff should be notified as soon as a new RGD has been
received so that it can be registered into the RGD inventory. All RGDs,
with the exception of certified television receivers or computer video
monitors, should be subject to inventory and accountability for
radiation protection and control purposes only. Inventory and
accountability of the receivers and monitors however, would still be
subject to applicable federal property management requirements.
Proposed use of administrative radiological controls to replace or
supplement design features for the RGD shall also be reviewed by the
radiation protection staff and the qualified expert (RCM 312 & 313).
Approval by the radiation protection staff and QAO shall be required
prior to procurement of the RGD and operation of the RGD installation
(RCM 311-313).
5. Normal Operations
Written instructions for normal operations "shall" be prepared for each
RGD installation and made available to RGD users and operators (10 CFR
835.1003(a) and ANSI N43.3(9.2)). The following shall be addressed as
essential elements:
-- Methods for posting controlled and radiological areas and for
controlling access to these areas and radiation sources (10 CFR
835.501, 10 CFR 835.601-603, and RCM 231 & 331-334);
-- methods and occasions for locking and securing radiation
sources;
-- methods for performing checks to determine that access controls and
safety devices are operational (i.e., operational inspections)
whenever the RGD is operated (10 CFR 835.501(d) and RCM 365.6);
-- methods to perform checks and to define response actions for any
stationary (area) monitor or device that is used for individual
safety to implement the requirements of 10 CFR 835.501(d) and RCM
365.6;
-- methods to perform functional inspections and checks of the safety
devices. These inspections are different from the operational
inspections and checks because they verify the adequacy and
effectiveness of the safety device design basis (10 CFR 835.501(d)
and RCM 365.6);
-- procedures to ensure that no individual may by-pass a safety device
or interlock. The approval of the radiation protection manager
shall be obtained for any deviation from this requirement in order
for this individual to comply with his/her responsibilities (ANSI
N43.3(9.1.4));
-- inspection of warning devices, if the devices are safety related
(10 CFR 835.501(d), RCM 365.6 and ANSI N43.3(8.7)), even if the
device does not serve a fail-safe function ;
-- instructions for handling and transporting RGDs (RCM 423, and DOE
Order 5480.3, "Safety Requirements for the Packaging and Transport
of Hazardous Materials, Hazardous Substances, and Hazardous Wastes"
(DOE, 1985));
-- calibration or alignment of the useful beam (10 CFR 835.1001(b) and
RCM 311). RGD manufacturer's instructions should be used for
developing these procedures;
-- the requirement for and proper wearing of personnel dosimetry (10
CFR 835.402(a) & (b) and RCM 511);
-- RGD and RGD installation operation and termination (ANSI
N43.3(9.2)). Resumption of any terminated operation due to unsafe
conditions requires the approval of both the radiation protection
manager and cognizant operations manager (RCM 345.4);
-- identification and instructions in the use of radiation protection
safety devices and equipment associated with the installation (ANSI
N43.3(9.2)). For any safety device that generates an audible or
visible alarm signal to comply with 10 CFR 835.502, procedures
"shall" define response actions (10 CFR 835.501(d) and RCM 334.10);
-- methods for surveying new or modified installations before
operation, including a requirement that surveys "shall" be performed
to verify that the boundaries have been properly posted and
controls have been established for any open installation operation
(10 CFR 835.401 & 10 CFR 835.501(d) and RCM 551 & 552);
-- methods, frequency, and instruments used for radiological surveys
of RGD installations (10 CFR 835.401 and RCM 551 & 552);
-- instructions for maintaining occupational dose, operational checks,
inspection and survey, operation, instrument calibration, and
testing records (10 CFR 835.702-704; RCM 754, 761& 762; and ANSI
N43.3(9.5.2), (8.7.4) and (9.6));
-- identification (by title) of operation managers and radiation
protection staff members who have responsibility for scheduling,
performing or reviewing survey, inspection and operational records
(RCM 751 & 752); and
-- methods for assuring the appropriateness and operational status of
portable survey instruments and stationary (area) radiation
monitoring devices, to meet the requirements of 10 CFR 835.401(c)
and RCM 561-563.
To be consistent with ANSI N43.3 and Federal regulations, instruments
used by operating personnel to survey "open installation" radiography
applications should be calibrated at least every 3 to 6 month period (10
CFR 34.24 and ANSI N43.3(9.6.2)). All instruments used to survey RGD
installations "shall" comply with 10 CFR 835.401(c) and RCM 562.
It should be specified that either a stationary (area) or portable
dose-rate indicating instrument can be used to satisfy the requirements
of 10 CFR 835.403(b) and 401(b). However, only portable instruments
should be used for entry surveys to verify that radiation levels have
been reduced to permissible levels or to determine that radiographic
sealed sources have been returned to a shielded position to implement
the requirements of 10 CFR 835.401(a)(5), 501(d), and 1003(a) & (b).
This requirement is also interpreted as an action which implements 10
CFR 835.501(d), if a stationary area monitor is used as a control
feature or device to comply with 10 CFR 835.502.
Further, RCM 553.2 specifies that area monitors should not be
substituted for radiation surveys in characterizing a workplace. The
above requirement satisfies this requirement also.
For any stationary area radiation monitor used as a control device, RCM 553
specifies additional requirements.
If a stationary (area) monitor is used solely to indicate that a pre-set
alarm threshold has been exceeded, calibrations may be limited to a
point below the alarm point and a point above the alarm point to ensure
that the monitor will not fail to perform its function if saturated.
For all other applications, entire range calibrations should be
performed in accordance with procedures that ensure capability to
measure ambient dose rates. In the event that calibration of monitoring
devices is not performed at the location where the instrument is
installed, procedures should include a provision to confirm the
calibration when the detector is returned to the stationary (area)
location.
The procedures "shall" emphasize that modification of an installation or
use with a different device or source than previously approved, shall be
evaluated by the same process as required for the design of a new
facility and require the same attention to radiation protection (10 CFR
835.501(b) & (d); DOE 5700.6C (Criterion 6); and RCM 312.4).
6. Off-Normal Operations
Management responsible for RGD installations "shall" develop procedures to
implement 10 CFR 835.1301(e) including any emergency response to alarms
(10 CFR 835.501(d) and RCM 346).
The written procedures for off-normal operations should address
requirements for the following essential elements (RCM 346):
-- Types of emergencies that may potentially be encountered, including
worst-case, individual overexposure, malfunctioning of equipment or
safety devices, and exposure to individuals who are not
radiological workers;
-- identification of the individuals and organizations that will be
notified in the event of an emergency; and
-- response actions involving notification of designated contractor
and DOE management (10 CFR 835.1301(e) and DOE Order 5000.3B,
"Occurrence Reporting and Processing of Operational Information"
(DOE, 1993c)) and other response actions including activation of
the emergency response plan, initiation of protective and
corrective actions, providing assistance to affected individuals,
and performing recovery actions.
Emergency planning for those RGD installations which need to be
energized to produce radiation should include the following conditions:
-- Failure of an RGD to turn off;
-- fire involving the installation;
-- radiation levels outside the installation in excess of prescribed
limits; and
-- failure to evacuate personnel from an exposure room prior to
producing radiation.
Emergency planning for sealed radioactive sources or small particle
accelerators (that use targets in which radioactivity can be induced) or
neutron generators should consider the following conditions:
-- Loss of radioactive material containment (airborne or surface
contamination);
-- loss of the sealed radioactive source, or of the source becoming
jammed in an unshielded position;
-- fire involving the installation;
-- radiation levels outside the installation in excess of prescribed
limits; and
-- failure to evacuate personnel from an exposure room prior to
producing radiation.
For all sealed radioactive sources, containment and decontamination of
affected areas and individuals should be addressed.
The site-specific RPP or RCM should emphasize that operational
procedures and emergency plans should be periodically reviewed and
updated as needed.
7. Maintenance
During preventative maintenance, beam alignment, or repair activities,
changes in the installation type can occur. For example, an exempt
shielded configuration becomes "open" due to the removal of shielding
and the bypassing of safety devices.
Due to the non-routine nature of these activities and a corresponding
increased potential for exposures, procedures "shall" describe the
administrative requirements for placing an RGD installation into and
taking it out of a maintenance mode (10 CFR 835.1001(b) and RCM 311) .
Authorizations for any maintenance activity should be obtained from the
radiation protection manager if the proposed activities have any
potential for radiological hazard. Radiation protection measures should
be included to compensate for the bypassing of any safety device or
interlock to maintain exposures ALARA. Posting requirements are
addressed in Section C.6.e., "Maintenance Status", of this IG.
8. RGD Decommissioning
The site-specific RPP or RCM should include procedures for
decommissioning RGD installations. The radiation protection manager
should review all requests for disposal of RGDs and material used in the
installation. RGDs shall be transferred off-site only to other
individuals or facilities that are authorized or licensed (by either a
State, the Nuclear Regulatory Commission, other Federal agency, or DOE)
to operate or use them to ensure that the dose limit to members of the
public is not exceeded (DOE Order 5400.5, "Radiation Protection of the
Public and the Environment", (DOE, 1990), Chapter II.1.a). RGDs that are
to be scrapped or salvaged must be disabled and any radioactive
components shall be removed and disposed of separately to implement DOE
Order 5400.5. Disposition records for all RGDs and associated equipment
should be retained in accordance with DOE record retention, property
management, and disposal orders. Requirements for sealed radioactive
sources are specified in DOE Notice N5400.9, as amended, "Sealed
Radioactive Source Accountability" (DOE, 1991b), DOE Order 5480.11, and
RCM 431.
Procedures for disposal of nonradioactive materials associated with RGDs
should be in accordance with applicable DOE directives. Attention shall
be given to ensure that all non-exempt radioactive materials have been
removed (e.g., sealed radioactive sources or thorium containing electron
tubes) and that no radioactive contamination remains before disposal.
X-ray generating devices should be thoroughly dismantled so that they
cannot be used without servicing by qualified technicians. Other
nonradioactive material, such as lead shielding, shall be disposed of in
accordance with the "Resources Conservation Recovery Act of 1976" (RCRA,
1976), as amended, and DOE directives.
Section IV, Subsection C - Implementation of Site-Specific Documents
C. Implementation of Site-Specific Documents
The site-specific RPP and RCM are implemented, in part, through
scheduled radiation surveys and inspections, which constitute the
actions that "shall" (to implement 10 CFR 835.401 & 501(d) and RCM 551) be
conducted: 1) before operating a new installation; 2) before operating a
modified installation; and 3) periodically while operating an
installation.
Inspections and surveys "shall" be performed to identify potential hazards
and deficiencies, to result in corrective actions or controls (10 CFR
835.401(a)(5) & (b); RCM 551, 552, & 554; and ANSI N43.3 (8.6.6.10)).
1. Pre-Operational Inspections
The elements that should be included in pre-operational inspections are
described in the following sections.
a. Review of Radiation Safety Procedures and Documentation
The manufacturer's design and construction diagrams of the RGD, the
engineering diagrams, the drawings depicting the physical layout of the
installation, and electrical safety interlock diagrams should be
reviewed to verify that the device and installation are accurately
reflected by this documentation and adequately designed. Operating and
emergency procedures shall be reviewed to ensure that procedures exist
and are satisfactory for the intended use (10 CFR 835.501(d), DOE
5700.6C (Criteria 5 & 6) and RCM 334.10).
b. Operational Factors
The current and expected occupancy of the areas adjacent to the
installation and their radiation exposure levels shall be determined
(ANSI N43.3(8.6.1)). Interviews should be conducted with the RGD
Operators and Custodian to assess RGD and equipment use time, expected
occupancy factors, and anticipated methods of operation.
c. Shielding
Administrative controls should be implemented to ensure that no
modifications to the RGD shielding are made without the review and
consent of the RGD Custodian and the radiation protection manager, and
that a pre-operational radiological survey is conducted that verifies
the adequacy of the shielding configuration.
d. Access and Control Devices
The proper location and proper functioning of access or control devices,
timing switches, interlocks, safety switches, and any system-control
interlock (i.e., current, position, time, etc.) "shall" be verified (10
CFR 835.501(d); DOE 5700.6C(Criterion 6), ANSI N43.3(8.6.2), and RCM
334.10).
e. Warning Devices
The proper location and proper functioning of warning devices, both
visual and audible, and interlocked warning lights "shall" be verified.
(10 CFR 835.501(d), ANSI N43.3 (8.6.2), DOE 5700.6C (Criterion 6), and
RCM 334.10).
f. Control Panel Configuration and Indicator Lights and Labels
The layout and proper functioning of control switches, indicator lights,
and location of appropriate labels located on the control panel shall be
verified (ANSI N537 (Sections 4, 5 and 6) and DOE 5700.6C (Criterion
6)).
g. Posting and Labeling
Signs and labels should be displayed as described in Sections IV.C.6,
IV.C.7, and IV.D.2 of this IG.
h. Personnel Dosimeters
The need for dosimeters (whole body and extremity) and their anticipated
use "shall" be reviewed for appropriateness and compliance with the
requirements of 10 CFR 835.402(a) & (b) and RCM 511. The requirement
for, and use of, direct reading, real time integrating dosimeters shall
be assessed, including the need for audibility to implement ANSI
N43.3(9.4.2) & (9.4.3). Further guidance is contained in the DOE
Implementation Guide, G-10 CFR 835/C2, "External Dosimetry Program" (DOE,
1994b).
i. Stationary (Area) and Portable Radiation Monitors
The pre-operational inspection shall review the need for area radiation
monitors and portable instrumentation and the appropriateness of the
location(s) where placed (DOE 5700.6C (Criterion 6)). The ability and
calibration of these monitors or instruments to perform their intended
functions "shall" be assessed and documented to comply with 10 CFR
835.401(c) and RCM 553.
2. Pre-Operational Radiation Surveys
Radiation surveys "shall" be conducted to determine and document the
integrity and adequacy of the shielding and to verify that posting and
access control requirements are satisfactory before the RGD is turned
over to the RGD Custodian for routine operation (10 CFR 835.401 and RCM
551). The areas adjacent to the installation, including above and
below, if occupiable, shall be surveyed and should be vacated when
pre-operational surveys are performed (ANSI N43.3(8.6.3)). Continuous
monitoring and surveys by the radiation protection staff "shall" be
performed during initial use of new or modified equipment until
integrity of shields, performance of interlocks, and operation of safety
devices is proven (10 CFR 835.401(a)(5) & 501(d), and RCM 551.4).
Specifically, the surveys are designed to:
-- Determine the exposure in units of dose rate or integrated dose
received in any 1 hour as dependent upon the pulse capability of
the RGD;
-- evaluate the RGD at the maximum value of applied voltage or
current, or at the maximum exposed position of the source for
sealed radioactive source installations. RGD(s) should be operated
in steps of increasing beam strength until the highest values are
achieved;
-- include the use of mechanical or electrical devices that restrict
beam orientation and magnitude, and determine the degree of beam
restriction, with and without those devices;
-- detect and measure potential leaks in the shielding and barriers;
and
-- encompass all geometries in which the useful beam can be directed.
3. Periodic Inspections and Radiation Surveys
Periodic inspections and radiation (radiological) surveys "shall" be
conducted to determine and document the continued integrity and adequacy
of the shielding and to verify that posting and access control
requirements remain satisfactory (10 CFR 835.401 & 501(d) and RCM 551).
ANSI N43.3(8.7.3) specifies that the inspections of safety devices are
not a substitute for radiation surveys. This means that surveys are to
be performed concurrently with the routine functional inspections of the
safety devices. The RCM specifies that "survey frequencies should be
established based on potential radiological conditions, probability of
change in conditions and area occupancy factors" (RCM 551.8).
Recommended minimum frequencies for routine operations are specified in
Appendix B of this IG.
In addition to the periodic operational radiation surveys specified
above, special surveys should be conducted by operational staff as
follows:
-- During the performance of maintenance and alignment procedures if
the procedures require the presence of a primary beam (RCM 552.3);
-- when any component in the system is disassembled or removed;
-- any time an inspection of the components in the system reveals an
abnormal condition;
-- whenever personnel monitoring dosimeters or surveys show a
significant increase over a previous monitoring period or are
approaching administrative limits; and
-- after any modification.
The radiation protection manager may remove an RGD from service and
place it in controlled "storage" during which it is exempt from routine
inspections and surveys. However, when any RGD which has been in
"storage" is being reactivated for use, functional and operational
inspections and radiological surveys "shall" be performed prior to initial
use (10 CFR 835.401(a) & (b), 10 CFR 835.501(d), and RCM 551).
Operational and functional inspections (i.e., checks which verify
operability prior to RGD use and adequacy of the design basis,
respectively) of safety devices and radiation surveys "shall" be performed
(10 CFR 835.501(d) and ANSI N43.3(8.7)). Recommended inspection
intervals are specified in Appendix B of this IG .
For open installations, where irradiation configurations and boundary
conditions are likely to change frequently, radiation surveys "shall" be
conducted in response to changing working parameters (10 CFR 835.401(a)
& (b) and RCM 551).
After the initial assessment, independent inspections and surveys
should be conducted by the radiation protection staff to verify: 1) that
RGD operations continue to remain safe; 2) that during the operation of
any open installation, the proper location and posting of boundaries is
maintained; and 3) that after any modification or removal from storage
of a RGD installation, the effectiveness and operability of safety
features are adequate (RCM 551-553).
All radiation surveys should be performed in accordance with Section
IV.C.2, "Pre-Operational Radiation Surveys", of this IG. In addition to
the mandatory inspections of the safety devices, interlocks, and
shielding, inspections should include all those items delineated in
Section IV.C.1, "Pre-Operational Inspections", of this IG.
Similar to the pre-operational radiological surveys, sources of
potential exposures identified by any survey or inspection "shall" be
controlled (10 CFR 835.401(b) and RCM 551.1).
4. Radiation Survey Report
A radiation survey report "shall" be prepared following any radiation
survey required by 10 CFR 835.401 and 10 CFR 835.403 & 404 (10 CFR
835.703(a) and RCM 752.1). Survey results should be recorded on
appropriate standard forms and shall include the following (RCM 751-752
and ANSI N43.3(8.6.6)):
-- Date, time, location, purpose, and person(s) performing the survey;
-- for a sealed radioactive source, identification of the RGD by
serial number, isotope, and activity in curies or expected dose
rate;
-- for a RGD which needs to be energized, the voltage and current at
which the RGD was operated during the survey;
-- category of the installation;
-- the location of the generating device and orientation of the useful
beam during each exposure measurement;
-- a description of mechanical and electrical limiting devices that
restrict the orientation of the useful beam or the orientation of
the RGD;
-- any restrictions upon the weekly workload, degree of occupancy, and
the length of time that the useful beam may be directed at any
installation shield;
-- instrument(s) used to conduct the survey, date of calibration, and
energy (or correction factor) used for calibration;
-- results of area dose rate measurements which includes all adjacent
occupiable areas (for open installations, this also includes the
locations which define the posting boundaries); and
-- a statement of compliance or delineation of the actions
necessary to achieve compliance.
5. Sealed Radioactive Source Leak Testing
A program of sealed radioactive source accountability and leak testing for
radioactive contamination and encapsulation integrity shall be implemented
(DOE Order 5480.11, DOE Notice N 5400.9, as amended, and RCM 431).
6. Area Posting
The RGD installation-specific procedures should include diagrams that
show the extent of the Controlled Areas, radiation areas, high radiation
areas, or very high radiation areas that they mark. Due to the nature
of RGD installation designs, posting "shall" be clearly and conspicuously
visible to individuals outside, in the installation, and in the area
adjacent to the installation (10 CFR 835.601(d); ANSI N43.3(5.1.6),
(5.1.9), and (5.3); and RCM 231, 232, 234 & 236). All other warning
signs should be displayed in a similar manner.
In addition to the posting, both 10 CFR 835.601(d) and RCM 231.7 specify
that dose rates or radiological protection instructions may be included
on or in conjunction with the posting.
a. Radiation Area
Areas where an individual can receive a dose as defined in 10 CFR 835.2
for a radiation area "shall" be posted with warning signs bearing the
words required by 10 CFR 835.603(a) and RCM 234.1. Table 2-3 of the RCM
requires additional wording on the posted signs. In open installations,
these signs mark the boundary of the first perimeter (outer) and shall
be used in conjunction with a physical barrier (10 CFR 34.42; RCM 231.9
& 10; and RCM 234).
b. High Radiation Area
Areas where an individual can receive a dose as defined in 10 CFR 835.2
for a high radiation area "shall" be posted with warning signs bearing
the words as required by 10 CFR 835.603(b) and RCM 234.1. Table 2-3 of
the RCM requires additional wording on the posted signs. In open
installations, these signs mark the boundary of the second perimeter
(inner) and shall be used in conjunction with a physical barrier (10 CFR
34.42; RCM 231.9 & 10 and RCM 234).
c. Very High Radiation Area
Areas where an individual can receive a dose as defined in 10 CFR 835.2
for a very high radiation area "shall" be posted with warning signs
bearing the words required by 10 CFR 835.603(c) and RCM 234.1. Table
2-3 of the RCM requires additional wording on the posted signs. In open
installations, this posting should be at a sufficient distance to
maintain surveyor exposures ALARA.
d. Operational Status
Radiological posting is required to signify the presence of an
intermittent radiation condition (RCM 231.1&12). The posting should
also express the method used to convey that a radiation field is
present. An example of such a sign is:
"CAUTION:
RADIATION BEING PRODUCED OR
RADIATION AREA EXISTS WHEN RED LIGHT IS ON"
e. Maintenance Status
Any time an installation requires maintenance, the entrance to the area
in which the installation is located and the inside of the installation
should be conspicuously posted to indicate the maintenance status of the
installation. To implement this for RGDs, posting is required:
-- During the performance of maintenance and alignment procedures
if the procedures require the presence of radiation; and
-- any time an inspection or survey reveals a deficient condition for
any safety device.
When a safety device or interlock has been approved to be by-passed or
is awaiting repair, the entrance to the installation and the RGD
enclosure should be posted with a prominent sign bearing the words
"SAFETY DEVICE NOT FUNCTIONING" or a similar message.
f. Additional Warning Signs
The entrance to exposure rooms shall be posted with a sign displaying
the radiation symbol and cautionary wording alerting personnel that they
are entering a radiation exposure room and that a survey instrument is
required (ANSI N43.3(5.1.6.3)), For example:
"CAUTION
ENTERING A RADIATION EXPOSURE ROOM
RADIATION SURVEY INSTRUMENT REQUIRED"
The posting requirement should not apply to all exempt shielded or
unattended (if located outdoors) installations.
Installations housing X-ray equipment shall have a sign on the outside
of the door (or enclosure) displaying the radiation symbol and the words
(ANSI N43.3(5.1.6.4)):
"CAUTION
X-RAYS"
or a reasonable equivalent.
Installations using a sealed radioactive source shall have a similar
sign but with the words:
"CAUTION
RADIOACTIVE MATERIAL"
or a reasonable equivalent.
For additional posting requirements for specific RGD installations, see
Section IV.D.2., "Requirements for Specific RGD Installations."
7. Labeling
Labels are used on the RGD assembly, the RGD installation control panel,
and access panels or doors of the RGD or RGD installation to convey
operational conditions or information as follows:
-- A shutter status indicator is required on RGDs if the emission of
the useful beam is controlled by shutters. The indicator may
consist of two visible mechanical or electrical signals of
contrasting color, or it may feature the message "on" and "off."
The tube assembly shall also display the basic radiation symbol.
The indicator and symbol should be readily observed by the operator
to indicate the "on-off" position of RGDs with shutter assemblies
(ANSI N43.5(6.4.1));
-- for X-ray RGDs, the control panel and tube assembly shall be
labeled as follows (or a reasonable eguivalent):
"CAUTION
THIS EQUIPMENT PRODUCES X-RAYS WHEN
ENERGIZED. TO BE OPERATED BY QUALIFIED
PERSONNEL ONLY"
NOTE: This statement should be legible at a distance of
at least 2 meters (ANSI N43.5(6.1) and N43.2(5.2.2.1.5)).
-- a label "shall" indicate the presence of radioactive material for
radioactive sources, if adequate warning is not provided by control
measures and required posting (10 CFR 835.601(a)). RCM 412, and
ANSI N43.2(5.2.2.1.7) require labeling with the words:
"CAUTION
RADIOACTIVE MATERIAL"
or equivalent wording and the standard radiation symbol. The label
shall also identify the radionuclide, activity, date of assay,
source model and serial number and RGD custodian (N 5400.9(7.c.1),
RCM 431.1 and ANSI N43.2(5.2.2.1.8));
-- when appropriate, a label indicating non-compliance to identify the
RGD as unsuitable for safe use (DOE 5700.6C (Criterion 5)). The
label should be color-coded to readily convey RGD status;
-- a label should be used to indicate approval by the radiation
protection staff that the RGD is suitable for safe use (i.e.,
operational) and the date of the last inspection or survey. The
label should be color-coded to readily convey RGD status;
-- a label stating that the radiation protection staff should be
notified when the RGD is to be moved, repaired, transferred, or
altered. The phone number of the radiation protection staff should
be included;
-- in the inoperative or storage mode, a label should be color coded
to accent visibility and indicate that electrical cables that
energize or activate the RGD should be disconnected, and that
radiation protection staff approval is required for resumption of
RGD use;
-- a label indicating the use and function of any "emergency shutdown
button" used to interrupt an irradiation sequence (ANSI
N43.3(5.1.5.2)); and
-- radiological instruments that are used for radiological surveys and
monitoring should bear a label or tag with the date of calibration
and the date the calibration expires (RCM 562.7).
8. Training
Before an installation is operated, both RGD custodians and operators
"shall" receive initial training (10 CFR 835.902, DOE 5700.6C (Criterion
2), and RCM 613) since these individuals are considered radiological
workers (i.e., 10 CFR 835 definition of radiological worker). General
requirements are provided in RCM 621 and 631 thru 634. Specific
requirements are provided in this IG.
Since, at RGD installations, a radiological worker is a general employee
who operates a RGD, retraining "shall" be provided to custodians and
operators when there is a significant change to radiation protection
policies or procedures that are associated with RGD use (10 CFR
835.901(b), 10 CFR 835.902, and RCM 613). Examples include RGD or
installation modifications or the assignment of different or additional
RGDs to a custodian or operator.
RCTs who perform inspections and surveys "shall" also be trained to
perform these duties (10 CFR 835.903, DOE 5700.6C (Criterion 2), and RCM
614). General requirements are specified in RCM 641 - 643. Such
training shall be comprehensive enough to address routine RGD operations
and to ensure that the RCT can recognize and control both normal and
changing radiological conditions associated with RGDs (RCM 641). After
initial training, retraining "shall" be performed at intervals not to
exceed 2 years for all RGD custodians, operators and RCTs (10 CFR
835.902 & 903; RCM 613; and DOE 5700.6C (Criterion 2)).
Radiological control technical staff and management training is
specified in RCM 654. Management who oversee and supervise RGD
operational personnel shall have training in the principles of the RCM
(RCM 651).
Training requirements for tour groups and visitors are addressed in RCM
622 and 657 and are applicable if the RGD is operated at the time of a
visit. Requirements for visiting scientists, researchers, or
specialists who may use a RGD, are specified in RCM 657.
RCM 655 requires that radiographers shall receive training in accordance
with 10 CFR 34.31 and that the operators of all other types of
installations should receive comparable training. However, 10 CFR 34
addresses radiography using a sealed radioactive source only and
stipulates requirements associated with a licensed activity performed
under the jurisdiction of the Nuclear Regulatory Commission (NRC). This
would apply to any NRC licensee that has been contracted by DOE to
perform this function. RCM 365.5(c) provides the requirements for this
situation.
There are applications where DOE or DOE contractor employees perform
radiography using a RGD other than a sealed radioactive source or at a
DOE facility not under the jurisdiction of an NRC or Agreement State
license. All RGD Operators, RGD Custodians, and RCTs at DOE facilities
shall receive training on the equipment they will be operating (RCM
655). The training should include the following topics (10 CFR 34
(Appendix A); ANSI N43.3; DOE 5700.6C; and RCM 655):
-- Characteristics of the type and levels of radiation produced by the
RGD (10 CFR 34);
-- units of radiation dose and radioactivity, as applicable (10 CFR
34);
-- hazards and biological effects of exposure to radiation (10 CFR
34), and the nature of injuries (including historical accident
cases) resulting from overexposure to the type of radiation
produced by the RGD (ANSI N43.3(9.1.2.));
-- principles and practices of radiation protection (i.e., time,
distance, and shielding) as applicable to the RGD (10 CFR 34);
-- use (checking, operation, calibration requirements, limitations) of
the radiation detection instrumentation applicable to the facility
(10 CFR 34); -- survey techniques (10 CFR 34);
-- use of personnel monitoring dosimeters (TLDs, pocket dosimeters,
and alarming rate-meters, as applicable)(10 CFR 34);
-- use of equipment associated with radiation devices or sealed
radioactive sources (e.g., remote handling, exposure positioning
devices and apparatus, storage containers) (10 CFR 34);
-- inspections of the safety devices and interlocks and required
maintenance (10 CFR 34); and
-- safe working practices (ANSI N43.3(9.1.2)).
In order to be fully comprehensive to meet the requirements of RCM 655
and DOE 5700.6C, the training should also include:
-- Lessons learned from incidents at similar installations within and
outside of DOE;
-- written procedures for routine and emergency operation;
-- pertinent DOE Rules, DOE Orders, regulations governing the use of
the RGD, and ANSI standards appropriate for each RGD installation
type;
-- area security and the use and meaning of RGD safeguards (locks,
signs, lights, visual and audible signals, and interlock systems);
-- operational record keeping;
-- survey and inspection record-keeping;
-- operational chain of communication for normal and emergency
response operations;
-- basic design, operation, and preventive maintenance of the RGD and
the installation; and
-- hazards of any associated electrical generating equipment (e.g.,
high voltage power supplies).
Maintenance and emergency personnel should be instructed in potential
hazards associated with the installation commensurate with their job
assignments (RCM 656). This includes specialized instructions for
non-routine situations, especially when the radiological hazards could
be substantially different from those normally encountered.
Radiological support personnel should be trained in ALARA, dose
reconstruction techniques, and job-specific radiation protection
requirements (RCM 652).
For special circumstances (e.g., subcontractors at DOE facilities who
have been trained and certified to meet similar state or other licensing
or certification authority requirements) the DOE training requirements
may be waived or modified at the discretion of the radiation protection
manager of the DOE facility or site. Records supporting this action are
still required, however.
9. Records
With respect to a radiation-generating devices radiation protection
program, the following types of records "shall" be maintained:
-- monitoring and workplace records (10 CFR 835.703 and RCM 751.1),
including sealed radioactive source accountability and leak testing
results (DOE Order 5480.11 and DOE Notice N 5400.9);
-- actions taken to maintain occupational exposures as low as
reasonably achievable (10 CFR 835.704(b) and RCM 742);
-- results of the surveys and inspections performed (10 CFR 835.703(a)
and RCM 751.1);
-- RGD installation protective measures required to be implemented to
ensure that individuals are not able to gain access to high or very
high radiation areas (10 CFR 835.701(a) and RCM 711);
-- installation design and administrative control features to demonstrate
compliance with 10 CFR 835.1001, 1002, and 1003 (10 CFR 835.704(b)
and RCM 742). Such records include schematic diagrams depicting
the wiring and logic for any interlocked safety feature;
-- results of internal audits and reviews (10 CFR 835.704(c) and RCM
743). Such reviews include the independent inspections and surveys
conducted by the radiation protection staff;
-- records demonstrating compliance with the reporting requirements of
10 CFR 835.801 1301(e) and RCM 781.4; and
-- changes in equipment, techniques, and procedures used for RGD
installation monitoring (10 CFR 835.704 (e) and RCM 751.2).
Further, operations and maintenance records shall be maintained for each
RGD installation and be made available to the radiation protection staff
upon request in order to implement the radiation protection staff safety
review in accordance with RCM 551.4.
Records and procedures specifying monitoring methods and techniques
should be maintained in chronological sequence that will allow
correlation with the corresponding support data (RCM 741). For example,
procedures for performing radiation surveys should correlate with the
survey results.
Completed RWPs (or alternative authorizations) should also be maintained
(RCM 741).
Records of quality assurance reviews and audits and ALARA plans and
goals developed for radiological control functions, shall be retained to
ensure that sufficient records are specified, prepared, reviewed,
approved, and maintained to accurately reflect RGD safety (RCM 343,
741-743 and DOE 5700.6C (Criterion 4)).
To meet the requirements specified above, the minimum records that
should be maintained by, and remain with, the RGD operational staff
include detailed RGD-specific operating procedures, operational and
maintenance log books, RGD-specific technical manuals and instructions,
training documents, entry control documents, and inspection and survey
results.
a. Operational Log Book
An operations log book "shall" be maintained for each RGD installation as
an action to document compliance with 10 CFR 835.501(d), 704(b), and
1003(a). This log will also serve to record actions to meet RCM 365.6
and DOE 5700.6C (Criteria 4 and 8). Entries into this log book shall
reflect the dates of safety device operational checks and inspections,
functional checks and inspections, radiation surveys, findings, and
corrective actions (ANSI N43.3(8.7.4)). Daily or scheduled entries
should be made for each operation of the RGD installation. Entries
should be sufficiently descriptive to ensure tracking of all aspects of
the operation, geometry, type of material being irradiated, and quality
of the radiation beam to reconstruct dose, if necessary. Periodic
review of the log book by operations management and the radiation
protection staff should be shown by sign-off. For open installations,
the log book shall include information on the installation layout and
survey boundaries to demonstrate that the required surveys have been
conducted (10 CFR 835.401(b) and RCM 551.1). However, the log book need
not contain all of the required information as long as this is
documented elsewhere and is readily available.
b. Maintenance Log Book
All maintenance work "shall" be described in a maintenance or combination
operations/maintenance log book as an action to document compliance with
10 CFR 835.501(d), DOE 5700.6C (Criterion 6), and RCM 334.10. Entries
should be initialed by the operations or management individual
responsible for the work.
All replacement parts installed should be listed in this log. Any
replacement part installed in the device should be the part prescribed
by the manufacturer unless the written concurrence of the following
individuals is obtained:
-- The cognizant Quality Assurance individual, if
applicable;
-- responsible operations manager; and
-- the radiation protection manager.
Concurrences should be annotated in the log book.
c. RGD Specific
The log books, interlock schematics (mechanical and electrical), and
manufacturer supplied operation and technical manuals "shall" be
maintained by, or available to, the responsible operations organization
or RGD Custodian, along with blue prints or other pertinent information
(as an action to comply with 10 CFR 835.501(d) and RCM 334.10). All
such records shall be updated to accurately reflect actual conditions
(RCM 713.1 and DOE 5700.6C (Criterion 4)).
d. Training
Records of formal classroom, on-the-job, and job-specific training and
qualification in radiological control "shall" be maintained to demonstrate
that RGD custodians and operators received appropriate training in
accordance with the above requirements to operate a RGD in a safe manner
(10 CFR 835.704(a), 902 & 903 and RCM 613, 614 & 725).
e. Inspections and Surveys
Records of RGD operational checks and inspections, functional checks and
inspections, surveys, dates, findings, and corrective actions performed
by the operating staff "shall" be maintained (as an action to show
compliance with 10 CFR 835.401 & 501(d), 703 & 704; RCM 365.6, 751& 752;
and ANSI N43.3(8.7.4)).
f. Entry Control
Documentation of the additional measures taken to control entry into very
high radiation areas "shall" be maintained to demonstrate compliance with
10 CFR 835.502(b), 703 & 704 and RCM 334.5, 751, & 752.
Section IV, Subsection D - Engineered Safety Controls
D. Engineered Safety Controls
RGD installations "shall" be designed so that radiation protection is
achieved primarily through physical controls, and secondarily through
administrative controls (10 CFR 835.1001 and RCM 311). ANSI N43.3 and
N43.2 describe specific requirements for exempt shielded (including
cabinet X-ray), shielded, unattended, and open installations. As
discussed in Section IV.B.2, "RGD Installation Design", of this IG, not
all of the ANSI requirements for shielded, unattended, and open
installations meet the requirements of 10 CFR 835.
As a consequence, the design of any new RGD installation or modification
of existing ones requires the use of installation designs that provide
adequate inherent shielding to meet the radiological exposure levels
discussed in Section IV.B.2, "RGD Installation Design", of this IG. The
alternative is the implementation of additional access and occupancy
controls to meet the design objectives.
Section IV.D.1, "Shielding, Controls, & Safety Devices", of this IG,
describes requirements for engineered (i.e., physical) safety controls
that are common to RGD installations. Specific criteria for each
installation type are provided in Section IV.D.2, "Requirements for
Specific RGD Installations", of this IG.
Requirements for engineered controls provided in this Section should be
considered in conjunction with requirements discussed in Section IV.B,
"Development of Site-Specific Documents", of this IG.
1. Shielding, Controls, & Safety Devices
RGD installations "shall" (10 CFR 835.1001(a) and RCM 311) include, as
essential measures, the following engineered safety controls:
a. Shielding
Shielding should be of assured quality, uniformity, and permanency to
attenuate radiation levels outside the enclosure of exempt shielded,
shielded, and unattended installations. Lead shielding shall be mounted
so that it does not cold-flow because of its weight and to be protected
from mechanical damage (ANSI N43.3(7.2.1)). Joints between similar or
different shielding materials shall be constructed so that the overall
protection of the shield is not reduced (ANSI N43.3(7.2.2), (7.3.1), and
(7.3.2)).
The following aspects of installed shielding should be considered to
ensure proper documentation and consideration of ANSI N43.3(Sections 6 &
7); as well as Appendices A, B, C, and D:
-- The thickness and type of shielding material, the arrangement of
the shielding material and devices, the locations of concrete used
for shielding, as well as the density and uniformity of the
concrete aggregate determined from samples cast during
construction;
-- the specified dimensions of shielding barriers or baffles;
-- the degree of overlap of primary shielding or between primary
shielding and other shielding or barrier materials;
-- the shielding behind electric boxes and lock assemblies;
-- the locations of shielded viewing windows, and the thickness and
densities thereof; and
-- the locations and dimensions of penetrations in the shielding walls
and doors.
Penetrations of the primary shielding to permit the passage of vents,
pipes, ducts, or cables shall also be shielded or baffled (ANSI
N43.3(7.4)).
The effect of temporary shielding should be evaluated prior to its
installation. The installation, use, and removal of temporary shielding
should be controlled by procedures and in accordance with RCM 314.
b. Access Control and Safety Devices
The purpose of the access control devices is to prevent entry into a
radiological area and/or to warn of a hazard.
The RCM (Appendix 3B) specifies that one or more of the following
features should be used for each entrance or access point to a high
radiation area and "shall" (10 CFR 835.502(a) and RCM, Appendix 3B) be
used for each entrance or access point to a high radiation area where
radiation levels exist such that a person could exceed a whole body dose
of 1 rem (0.01 Sv) in any one hour:
(1) A control device that prevents entry to the area when high
radiation levels exist or upon entry causes the radiation level to
be reduced below that level defining a high radiation area;
(2) a device that functions automatically to prevent use or operation
of the radiation source or field while individuals are in the area;
(3) a control device that energizes a conspicuous visible or audible
alarm signal so that the person entering the high radiation area
and the supervisor of the activity are made aware of the entry
(Note: Administrative procedures "shall" define the required actions
of personnel when alarms are activated to demonstrate compliance
with 10 CFR 835.501(d) and RCM 334);
(4) entryways that are locked, except during periods when access to the
area is required, with positive control over each entry;
(5) continuous direct or electronic surveillance that is capable of
preventing unauthorized entry; and
(6) a control device that automatically generates both audible and
visual alarm signals to alert personnel in the area before use or
operation of the radiation source and in sufficient time to permit
evacuation of the area or activation of secondary control devices
to prevent use or operation of the source.
Of all the access control options specified above, Subparagraph (2), is
preferred because the device directly controls the source of radiation.
The selection and implementation of subparagraph options (1), (3), or
(6) should require the review and approval of the radiation protection
manager and the cognizant operations organization.
If locked entryways are used, the keys used for one RGD installation or
storage facility should not provide access to another RGD installation
or storage facility.
Additional measures "shall" (10 CFR 835.502(b) and RCM Appendix 3B) be
implemented to ensure individuals are not able to gain access to very
high radiation areas when dose rates are in excess of the posting
requirements of 10 CFR 835.603(c) or RCM Table 2-3. Such measures
(i.e., physical constraints) include locking or securing service doors
and panels with tamper resistant fasteners (ANSI N43.3(5.2.2.4)), or the
use of multiple and redundant access controls.
Additional requirements that apply to shielded installations are
specified in Section IV.D.2.b., "Shielded Installations", of this IG.
Due to the lack of intrinsic shielding and the nature of use, access to
a very high radiation area could be possible for a "open" installation.
Additional measures (e.g., interlocked "photoelectric eye" light beams)
should be established to meet this requirement.
Physical access controls over radiological areas "shall" (10 CFR
835.501(e) & 502(c); RCM Appendix 3B.3; ANSI N43.3(5.1.4)) be
established in such a way that does not prevent a person from rapidly
evacuating the area.
c. Interlocks
To implement the requirement of 10 CFR 835.502(a)(1) thru (3) and RCM
Appendix 3B.1(a-c), the device must be interlocked to provide a safe or
fail-safe condition to maintain exposures ALARA. Doors and/or access
panels in exempt shielded, shielded, and unattended installations shall
be equipped with one or more fail-safe safety interlocks to prevent
irradiation of an individual (ANSI N43.3(6.5.2)).
If an area radiation monitor is incorporated into a safety interlock
system, the circuitry shall be such that a failure of the monitor shall
either prevent normal access into the area or operation of the RGD (RCM
553.6)
Additional requirements that apply to shielded installations are
specified in Section IV.D.2.b., Shielded Installations, of this IG.
Current, as-built schematic diagrams (mechanical and electrical) of
safety interlocks shall be maintained by, or available to, the RGD
Custodian (see Section IV.C.9.c., RGD Specific Records of this IG)(10
CFR 835.1001(a) and RCM 311).
d. Device Controls
One or more physical control devices should be used to secure the RGD to
prevent unauthorized access and use. The control system governing the
production of radiation should be equipped with a lock and key to
prevent unauthorized use. The key controlling the production of
radiation in one RGD should not control the production in another.
Control devices used to limit RGD time, position (irradiation geometry),
current, voltage, beam intensity, or control panel lights or system
indicators shall be fail-safe to demonstrate the "proper operation"
required by ANSI N43.3(7.6.2) and ANSI N43.2(5.2.2.1.4.). If used for
individual safety, these devices "shall" (10 CFR 835.501(d) and RCM 334)
be inspected and checked. Recommended inspection frequencies are
specified in Appendix B of this IG.
e. Run-Safe and Emergency Shutdown Devices
Administrative procedures "shall" (10 CFR 835.501(d) and RCM 334) be
implemented to ensure that the RGD installation and the RGD safety
interlock control devices are such that:
-- Radiation cannot be produced until the interlock system logic has
been completely satisfied;
-- production of radiation cannot be resumed by merely reestablishing
the interlock circuit at the location where an interlock was
tripped; and
-- the safety circuit shall be re-energized or reestablished manually
(preferably the safety circuit reset is on or near the main control
console).
See Section IV.D.2.b, "Shielded Installations", for emergency shutdown
requirements.
f. Warning Devices
For each area designated as a high radiation area or very high radiation
area, 10 CFR 835.502 and the RCM (Appendix 3B) provide an option that
permits a control device to automatically generate audible or visible
alarm signals to alert individuals and the cognizant RGD Custodian of a
potential entry into the area before it occurs. In order to meet ANSI
N43.3 requirements, warning devices shall be provided as an addition to
any other access control feature in accordance with the installation
specific requirements delineated in Section IV.D.2, "Requirements for
Specific RGD Installations", of this IG. These warning devices are
typically warning lights.
All RGD warning lights should be red for consistency (ANSI
N43.5(6.2.1)). A sufficient number of lights should be installed so
that at least one light is easily visible from all reasonably occupied
areas and from reasonable avenues of approach to such areas.
However, warning lights (even though interlocked to fail-safe if burnt
out) are only passive in nature. When operating, they generally do not
prevent an individual from physical access to a radiation beam unless
they are used as part of a photosensitive circuit. Such a circuit would
remove the radiation beam or field if any individual intercepted the
light beam.
Due to the passiveness (i.e., reliance on worker attention and action)
of this safety feature and the potential for failure, at least one
interlocked warning light should be used in all circumstances. The
interlocked warning light should be used to provide "visual indication"
that radiation is being produced, and should be used in conjunction with
any interlocked safety device which restricts physical access to a
radiation beam or field. This is recommended above and beyond the
installation specific requirements in Section IV.D.2 of this IG, or the
minimum required by 10 CFR 835.502. When used in this fashion, the RGD
shall not be operable when the warning light is out (ANSI N43.3(5.1.3),
(5.1.5), & (8.6.2) and ANSI N43.2(5.2.2.1.4)).
It should not be possible to override the operation of any warning
device activated by a fail-safe function without positive actions by the
operator such as resetting controls at the control console (see Section
IV.D.1.e., "Run-Safe and Emergency Shutdown Devices", of this IG).
g. Monitoring Instruments
Requirements for instruments used to measure radiation are given in 10
CFR 835.401(c) and RCM 551, 553, and 562.
2. Requirements for Specific RGD Installations
In addition to the general requirements in Section IV.D.1, of this IG,
there are specific requirements cited from ANSI N43.3 and N43.2 for each
of the primary RGD installations and the open and shielded beam
analytical RGDs. The analytical RGD installations may enclose one or
more X-ray devices and/or sealed radioactive sources.
The ANSI standards specify dose rates that are to be used for
installation categorization only and are not to be interpreted as
permissible levels.
The following requirements are specific for each installation or RGD
type.
a. Exempt Shielded Installations
Requirements for exempt shielded installations are:
-- The RGD and all objects exposed to the source of radiation shall be
within a permanent enclosure which, under all circumstances of use,
possesses sufficient inherent shielding to meet the following dose
rate limit (ANSI N43.3(4.1.1));
-- the exposure at any accessible region 2 inches (5 cm) from the
outside surface of the enclosure shall not exceed 0.5 mrem (5 ęSv)
in any 1 hour (ANSI N43.3 ( 4.1.1); and
-- the requirements as cited in ANSI N43.3(4.1.1) and (5.1.10).
b. Shielded Installations
Requirements for shielded installations are:
-- The RGD and all objects exposed to the source are within a
permanent enclosure from which persons are excluded during the
irradiation (ANSI N43.3(5.1.1));
-- interlocks shall be provided to prevent personnel access and
audible or visible warning signals shall be provided within the
enclosure (ANSI N43.3(5.1.2) and (5.1.3)). In lieu of the audible
or visible signal, ANSI N43.3(5.1.3.3.) permits the use of two
interlocks (at minimum) to prevent personnel access to X-ray
installations;
-- for any RGD that produces a radiation level in excess of 500 rads/h
at 1 meter (or 500 R/h at 3 feet), both audible and visible warning
signals are required (10 CFR 835.502(b), RCM 334.2, and ANSI
N43.3(5.1.5) (NOTE: This does not apply to installations where
personnel access into the very high radiation areas is not
possible);
-- at least one or more "emergency shutdown buttons" shall be
installed inside the shielded enclosure (if humanly occupiable) of
the installation in conspicuous locations that are easily and
directly accessable to allow rapid activation in the event of an
emergency. The shutdown device shall provide an effective means of
quickly interrupting the RGD operational sequence prior to or
during production of the useful beam or during the movement of an
RGD from a shielded to unshielded position (ANSI N43.3(5.1.5.2)) .
See Section IV.C.7, "Labeling", of this IG for labeling requirements;
-- when entering the exposure area, enclosure, or room after
irradiation, the operator shall use a survey meter to verify that a
sealed radioactive source has been returned to its shielded storage
location or that radiation is no longer being produced by the RGD
(RCM 334.5 and 552.1.c.; and ANSI N43.3(9.3.1.5));
-- if the installation is of the walk-in type, a prominently posted
sign inside the exposure room should read:
"WHEN WARNING SIGNAL IS ON,
VACATE ROOM IMMEDIATELY"
where such warning devices areinstalled.
Another sign posted at the entrance should read:
"CAUTION
ENTERING A RADIATION EXPOSURE ROOM
DO NOT ENTER
WHEN WARNING SIGNAL IS ON"
-- Also, other requirements cited in ANSI N43.3(5.1 and 9.3.1) should
be met.
For any installation that is being operated as an irradiator facility
under the jurisdiction of a NRC license, Subpart C of 10 CFR 36,
"Licenses and Radiation Safety Requirements for Irradiators" (NRC, 1993)
provides additional design and performance requirements.
c. Unattended Installation
Requirements for unattended installations are:
-- That the RGD is installed in a single-purpose shielded
enclosure (ANSI N43.3(5.2.1.1)); and
-- the other requirements cited in ANSI N43.3(4.2) and (5.2).
The design shall ensure that individuals are not exposed to doses
exceeding 100 mrem (1 mSv) in a year. If it is not possible to
demonstrate that an individual receives less than this limit and
occupancy rates in the vicinity of the installation are known to be low,
a short-term limit of 2 mrem (0.02 mSv) in any 1 hour may be used
provided that a radiation survey or monitoring device shows that the
expected dose to an individual is less than 100 mrem (1 mSv) per year
(ANSI N43.3(5.2)).
d. Open Installation
Requirements for open installations are:
-- A conspicuously posted and defined perimeter, visible from any
approach, that limits the area in which the exposure can exceed 5
mrem (0.05 mSv) in any 1 hour (ANSI N43.3(5.3.3)). The posting
should be in accordance with Section IV.C.6.a, "Radiation Area", of
this IG;
-- a conspicuously posted and defined perimeter, visible from any
approach, that limits the area in which the exposure can be or
exceed 100 mrem (1 mSv) in any 1 hour (ANSI N43.3(5.3.1)). The
posting should be in accordance Section IV.C.6. b, "High Radiation
Area", of this IG;
-- a conspicuously posted and defined perimeter, visible from any
approach, for a potential very high radiation area, where the
"additional control measures" apply as required by Section IV.D.1
(b), "Access Control and Safety Devices", of this IG;
-- the operational staff "shall" provide constant surveillance to ensure
that no person has physical access to the high radiation or very
high radiation area within the perimeter or remain in the area
during the irradiation and operation of the RGD (ANSI
N43.3(5.3.4));
-- RGD source and equipment essential to use shall be attended by a
knowledgeable person or kept in a locked enclosure to ensure that
the RGD is not used by un-authorized individuals, tampered with, or
removed (RCM 431 and ANSI N43.3(5.3.4);
-- the performance of radiation surveys to define the boundaries
specified above (10 CFR 835.401, RCM 551, and ANSI N43.3(5.3));
-- when entering the operating area after irradiation, the operator
"shall" use a survey meter to verify that a radioactive source has
been returned to its storage location or that radiation is no
longer being produced (10 CFR 835.501(d) and 401(a)(5), 10 CFR
34.43(b), RCM 334.5 and 552.1.c., and ANSI N43.3(9.3.3.3.1));
-- temporary shielding should be used in accordance with RCM 314;
-- all individuals "shall" wear a primary whole body dosimeter (10 CFR
835.402(a)(1)(i) and RCM 511.1.a);
-- all individuals shall wear supplemental dosimeters (a direct
reading and alarming dosimeter) in addition to the primary
dosimeter (10 CFR 34.33, ANSI N43.3(9.4.2) & (9.4.3) and RCM 513);
-- extremity dosimeters "shall" also be used where potential doses to
the extremities may be 5 rems (0.05 Sv) or greater in a year (10
CFR 835.402(a)(1)(ii) and RCM 511.1.a);
-- the other requirements as cited in ANSI N43.3(5.3) and (9.3.3);
-- all radiography using byproduct material as a sealed radioactive
source (and not under an NRC license) should be conducted in
accordance with 10 CFR 34 as modified by the site-specific RCM or
RPP and this IG for onsite operations at DOE facilities; and
-- all radiography conducted by offsite contractors at DOE facilities
shall be conducted in accordance with RCM 431.9 4 and 10 CFR 34 or
equivalent Agreement State requirements (RCM 365.5), and the degree
of on-site oversight shall be determined by the on-site radiation
protection manager.
e. Analytical Devices: Enclosed Beam Installations
In this subclass of installation, the radiation source, sample and
detector (if used) are enclosed in an exempt shielded enclosure or
chamber that prevents inadvertent entry of any part of the body during
normal operations. The inherent shielding and access controls for these
devices allow activities in close proximity to the device while the beam
is activated. It is not uncommon for several of these devices to be
operated in the same room. Requirements for warning devices, interlocks,
etc., are similar to those used for the exempt shielded (cabinet-type)
installations and those requirements for the engineered controls.
Additional requirements are cited in ANSI N43.2(5.2.2.1) & (5.2.2.3).
f. Analytical X-Ray Devices: Open Beam Installations
In this subclass of installation, the sample to be analyzed cannot be
enclosed in a exempt shielded chamber or enclosure. A shutter controls
the presence of the radiation beam. The shutter is opened after the
operator leaves the room or moves to a safe distance behind barriers or
shielding.
Requirements are similar to a shielded installation. A system barrier
for the operators should be part of the installation to prevent
inadvertent access to the RGD during normal operations (ANSI
N43.2(5.2.2.2.6)). The barrier should have sufficient inherent shielding
so that the exposure received by any individual does not exceed the
design criteria specified in Section IV.B.2., "RGD Installation Design",
of this IG. Additional requirements for this type installation are
cited in ANSI N43.2(5.2.2.1 & .2).
g. Particle Accelerators
Small (low voltage, less than or equal to 10 MeV) particle accelerators
used for radiography, ion implantation, or the production of incidental
photons or particles (e.g., neutron generators) in exempt shielded,
shielded, or open installations are subject to the requirements
specified by this IG and the applicable ANSI standards. When
accelerators are used outside of exempt shielded or shielded
installations, requirements for open-air radiography prevail.
When used within shielded installations, determination must be made
whether the requirements for the exempt shielded or shielded
installations prevail. Although the basic radiation protection program
requirements discussed in this guide are generally applicable to the
large multi-purpose research accelerators, the complexities associated
with these facilities may require additional consideration beyond the
scope of this guide. Additional requirements for those RGDs with
particle energies exceeding 10 MeV are provided in DOE Order 5480.25,
"Safety of Accelerator Facilities" (DOE, 1992c).
For any accelerator which produces neutrons (e.g., proton or deuteron
particle generator using a tritium target), procedures "shall" also
address contamination control and monitoring (10 CFR 835.404 and RCM
337).
h. Electron Devices that Generate X- Rays Incidentally
These devices are usually shielded to attenuate the emission of X-rays.
Requirements for the exempt shielded or shielded installations prevail.
Examples include electron beam welders, electronic microscopes, pulse
generators, etc., and microwave cavities if used as beam guides.
Preoperational inspections and surveys should be performed initially
upon receipt. However, the requirement for the routine semiannual
inspections and surveys may be modified at the discretion of the
radiation protection manager. Inspections and surveys should be
performed after any modification. In the absence of modifications, the
radiation protection staff "shall" conduct independent inspections and
surveys (10 CFR 835.401(a)(5) & 501(d) and RCM 551.4).
i. Cabinet X-Ray Systems
Since these RGDs are used primarily in security applications and are
commercially available, manufacturer requirements for these RGDs are
delineated in 21 CFR Part 1020.40.
These RGDs shall be procured, categorized, inventoried, operated,
inspected and surveyed, and decommissioned in accordance with the
requirements of this IG to ensure compliance with 10 CFR 835.1001& 1003
and RCM 311). Inspections and surveys should be performed as specified
in section IV.D.2.h., "Electron Devices that Generate X-Rays
Incidentally", of this IG.
If not commercially obtained, the requirements for an exempt shielded
installation prevail.
Section V - References
V. REFERENCES
(AEC, 1954) Atomic Energy Act of 1945, as amended. Public Law 83-703
(68 Stat. 919), Title 42 U.S.C. sec. 2011.
(ANSI, 1989a) American National Standards Institute. 1989. "Radiation
Safety for X-Ray Diffraction and Fluorescence Analysis Equipment." ANSI
N43.2-1977(R1989). New York, New York.
(ANSI, 1989b) American National Standards Institute. 1989.
"Radiological Safety Standard for the Design of Radiographic and
Fluoroscopic Industrial X-Ray Equipment." ANSI N43.5-1976 (R1989). New
York, New York.
(ANSI, 1993) American National Standards Institute. 1993. "American
National Standard For General Radiation Safety -Installations Using
Non-Medical X-Ray and Sealed Gamma-Ray Sources, Energies up to 10 MeV."
ANSI N43.3-1993. New York, New York.
(DOE, 1984) U.S. Department of Energy. 1984. "Environmental Protection,
Safety, and Health Protection Standards." DOE Order 5480.4. Washington,
D.C.
(DOE, 1985) U.S. Department of Energy. 1985. "Safety Requirements for
the Packaging and Transportation of Hazardous Materials, Hazardous
Substances, and Hazardous Wastes." DOE Order 5480.3. Washington, D.C.
(DOE, 1990) U.S. Department of Energy. 1990. "Radiation Protection of
the Public and the Environment." DOE Order 5400.5. Washington, D.C.
(DOE, 1991a) U.S. Department of Energy. 1991. "Quality Assurance." DOE
Order 5700.6C. Washington, D.C.
(DOE, 1991b) U.S. Department of Energy. 1991. "Sealed Radioactive
Source Accountability." DOE Notice N 5400.9. Washington, D.C.
(DOE, 1992a) U.S. Department of Energy. 1992. "Radiation Protection for
Occupational Workers." DOE Order 5480.11. Washington, D.C.
(DOE, 1992b) U.S. Department of Energy. 1992. "Contractor Occupational
Medical Program." DOE Order 5480.8A. Washington, D.C.
(DOE, 1992c) U.S. Department of Energy. 1992. "Safety of Accelerator
Facilities." DOE Order 5480.25. Washington, D.C.
(DOE, 1993a) U.S. Department of Energy. 1993. "Occupational Radiation
Protection." 10 CFR 835, 58 FR 65458, Federal Register, Vol. 58, No. 236:
December 14, 1993. Washington, D.C.
(DOE, 1993b) U. S. Department of Energy. 1993. "Procedural Rules for
DOE Nuclear Activities." 10 CFR 820, 58 FR 43680, Federal Register, Vol.
58, No.157: August 17, 1993. Washington, D.C.
(DOE, 1993c) U.S. Department of Energy. 1993. "Occurrence Reporting and
Processing of Operational Information." DOE Order 5000.3B. Washington,
D.C.
(DOE, 1993d) U.S. Department of Energy. 1993. "Environment, Safety and
Health Policy for the Department of Energy Complex." DOE Policy
Statement, dated July 20, 1993. Washington, D.C.
(DOE, 1993e) U.S. Department of Energy. 1993. "Radiological Health and
Safety Policy." DOE Notice N 5480.8. Washington, D.C.
(DOE, 1994a) U.S. Department of Energy. 1994. "Radiological Control
Manual." DOE/EH-0256T. Washington, D.C.
(DOE, 1994b) U.S. Department of Energy. 1994. "Implementation Guide for
10 CFR 835 - External Dosimetry Program." G-10 CFR 835/C3 - Rev. 1.
Washington, D.C.
(HHS, 1992) U.S. Department of Health and Human Services, Food and Drug
Administration. 1992. "Radiological Health." 10 CFR 21(1)(J). Washington,
D.C.
(NRC, 1992) U.S. Nuclear Regulatory Commission. 1992. "Licenses for
Radiography and Radiation Safety Requirements for Radiographic
Operations." 10 CFR 34. Washington, D.C.
(NRC, 1993) U.S. Nuclear Regulatory Commission. 1993. "Licenses and
Radiation Safety Requirements for Irradiators." 10 CFR 36, Subpart C, 55
FR 7715, Federal Register, Vol.58, No.25: February, 9, 1993.
Washington, D.C.
(RCRA, 1976) "Resource Conservation and Recovery Act of 1976," as amended.
Public Law 94-580. Washington, D.C.
Section VI - Supporting Documents
VI. SUPPORTING DOCUMENTS
10 CFR 20. U.S. Nuclear Regulatory Commission. 1991. "Standards for
Protection Against Radiation." Bethesda, Maryland.
American National Standards Institute and The American Society of
Mechanical Engineers. 1986. "Quality Assurance Program Requirements for
Nuclear Facilities." ANSI/ASME NQA-1-1986. ASME. New York, New York.
American National Standards Institute. 1972. "Performance Specifications
for Direct Reading and Indirect Reading Pocket Dosimeters for X- and
Gamma Radiation." ANSI N13.5-1972. U.S. Department of Commerce.
Washington, D.C.
American National Standards Institute. 1978. "Safe Design and Use of
Self-Contained, Dry Source Storage Gamma Irradiators (Category I)." ANSI
N433.1, U.S. Department of Commerce. Washington, D.C.
American National Standards Institute. 1978. "Sealed Radioactive
Sources, Classification." ANSI N542. U.S. Department of Commerce.
Washington, D.C.
American National Standards Institute. 1984. "Safe Design and Use of
Panoramic, Wet Source Storage Gamma Irradiators (Category IV)." ANSI
N43.10-1984. U.S. Department of Commerce. Washington, D.C. (Also
available as NBS Handbook 142.)
American National Standards Institute. 1988. "Classification of
Industrial Ionizing Radiation Gaging Devices." ANSI N43.8-1988. U.S.
Department of Commerce. Washington, D.C.
American National Standards Institute. 1991. "American National Standard
for Gamma Radiography - Specifications for Design and Testing of
Apparatus." ANSI N43.9, U.S. Department of Commerce. Washington, D.C.
American Welding Society, Inc. 1978. "Recommended Safe Practice for
Electron Beam Welding and Cutting." AWS F2.1-78. American Welding
Society. Miami, Florida.
Argonne National Laboratory. 1987. "Appraisal and Survey of an Electron
Microscope, Health Physics Procedures." HPP-704. Argonne National
Laboratory. Argonne, Illinois.
International Atomic Energy Agency. 1989. "Emergency Planning and
Preparedness for Accidents Involving Radioactive Materials Used in
Medicine, Industry, Research and Teaching." Safety Series Report No. 91.
Vienna, Austria.
International Atomic Energy Agency. 1990. "Extension of the Principles
of Radiation Protection to Sources of Potential Exposure." Safety Series
Report No. 104. Vienna, Austria.
Klein, H. F., ed. 1972. "Radiation Safety and Protection in Industrial
Applications." DHEW Publication No. (FDA) 73-8012. U.S. Department of
Health, Education, and Welfare. Rockville, Maryland.
Moore, T. M., W. E. Gundaker, and J. W. Thomas, eds. 1971. "Radiation
Safety in X-Ray Diffraction and Spectroscopy." DHEW Publication No.
(FDA) 72-8009. U.S. Department of Health, Education, and Welfare.
Rockville, Maryland.
National Council on Radiation Protection and Measurements. 1964. "Safe
Handling of Radioactive Materials." NCRP Report No. 30. Bethesda,
Maryland.
National Council on Radiation Protection and Measurements. 1976.
"Structural Shielding Design and Evaluation for Medical Use of X Rays and
Gamma Rays of Energies Up to 10 MeV." NCRP Report No. 49. Bethesda,
Maryland.
National Council on Radiation Protection and Measurements. 1977.
"Radiation Protection Design Guidelines for 0.1-100 MeV Particle
Accelerator Facilities." NCRP Report No. 51. Bethesda, Maryland.
National Council on Radiation Protection and Measurements. 1978.
"Operational Radiation Safety Program." NCRP Report No. 59. Bethesda,
Maryland.
National Council on Radiation Protection and Measurements. 1978.
"Instrumentation and Monitoring Methods for Radiation Protection." NCRP
Report No. 57. Bethesda, Maryland.
National Council on Radiation Protection and Measurements. 1978.
"Radiation Safety Training Criteria for Industrial Radiography." NCRP
Report No. 61. Bethesda, Maryland.
National Council on Radiation Protection and Measurements. 1983.
"Radiation Protection and Measurement for Low-Voltage Neutron Generators."
NCRP Report No. 72. Bethesda, Maryland.
National Council on Radiation Protection and Measurements. 1987.
"Radiation Alarms and Access Control Systems." NCRP Report No. 88.
Bethesda, Maryland.
National Council on Radiation Protection and Measurements. 1987.
Recommendations on Limits for Exposure to Ionizing Radiation." NCRP
Report No. 91. Bethesda, Maryland.
National Council on Radiation Protection and Measurements. 1989.
Medical X-ray, Electron Beam and Gamma-ray Protection for Energies Up to
50 MeV (Equipment Design, Performance and Use)." NCRP Report No. 102.
Bethesda, Maryland.
Parsons, D. F., V. A. Phillips, and J. S. Lally. 1974. "The
Radiological Significance of X-Ray Leakage from Electron Microscopes."
Health Phys. 26:439-448.
U.S. Department of Energy. 1981. "Environmental Protection, Safety, and
Health Protection Program for DOE Operations." DOE Order 5480.1A.
Washington, D.C.
U.S. Department of Energy. 1988. "Operational Health Physics Training."
ANL-88-26. Washington, D.C.
U.S. Food and Drug Administration. 1986. "Suggested X-Ray Survey
Procedure Manual." Conference Publication 96-5. Washington, D.C.
U.S. Nuclear Regulatory Commission. 1984. "Guide for the Preparation of
Applications for the Use of Sealed Sources and Devices for Performing
Industrial Radiography." Regulatory Guide 10.6. Bethesda, Maryland.
U.S. Nuclear Regulatory Commission. 1988. "Guide for the Preparation of
Applications for Licenses for the Use of Self-Contained Dry
Source-Storage Gamma Irradiators." Regulatory Guide 10.9. Bethesda,
Maryland.
Appendix A - Manual Cross-Reference
Appendix A
10 CFR 835, Implementation Guide, and DOE Radiological Control
Manual Cross-Reference
10 CFR 835 Implementation Guide Radiological Control Manual
----------------------------------------------------------------------------
835.101 III & IV.B.2 -
835.101(a) IV & IV.B 114
835.101(c) IV 128
835.101(e) & (f) IV 114
835.202 III 213.1
835.207 IV.B.2 Table 2-1
835.208 IV.B.2 Table 2-1
835.401 IV.B.5, IV.C, IV.C.1, 365.6 & 551-555
IV.C.3.a & IV.C.9.e
835.401(a) & (b) IV.C & IV.C.2-3 551, 552 & 554
835.401(a)(5) IV.A.2.d & IV.A.2.h 551.4 & 552.1.c
835.401(b) IV.C.3 & IV.C.9.a 551.1
835.401(c) IV.B.5 & IV.C.1.i 553 & 561-563
835.402(a)(1)(i) IV.A.2.d 511.1.a
& (ii)
835.402(a) & (b) IV.B.5 & IV.C.1.h 511
835.404 IV.A.2.g 337
835.501(b) IV.B.5 312.4
835.501(d) IV.B.5, IV.C, IV.C.1.d, 312.4, 334, 346, 365.6,
IV.C.1.e, IV.C.2, IV.C.3, 551 & 552
IV.C.9(a, b, c, & e),
IV.A.1(b, d, & e) &
IV.A.2(d & h)
835.501(e) IV.A.1.b Appendix 3B.3
835.502(a) IV.A.1.b Appendix 3B
835.502(b) IV.A.1.b, IV.A.2.b & IV.C.9.f 334.2 & 5, Appendix 3B &
Appendix 3B.3
835.502(c) IV.A.1.b Appendix 3B.3
835.601 IV.B.5 231 & 331-334
835.601(a) IV.C.7 412
835.601(d) IV.C.6 231, 232, 234 & 236
835.602 IV.B.5 231 & 331-334
836.603 IV.B.5 231 & 331-334
835.603(a) IV.C.6.a 234.1
835.603(b) IV.C.6.b 234.1
835.603(c) IV.C.6.c 234.1
835.701(a) IV.C.9 711
835.702 IV.B.5 754, 761 & 762
835.703 IV.B.5 & IV.C.9(e) & (f) 751, 752, 754, 761 & 762
835.703(a) IV.C.4 & IV.C.9 751.1 & 752.1
835.704 IV.B.5 & IV.C.9(e) & (f) 751, 752, 754, 761 & 762
835.704(a) IV.C.9(d) 725
835.704(b) IV.C.9 & IV.C.9(a) 742
835.704(c) IV.C.9 743
835.704(e) IV.C.9 751.2
835.901(b) IV.C.8 613
835.902 IV.C.8 & IV.C.9.d 613
835.903 IV.C.8 & IV.C.9.d 614
835.1001 IV.A 311
835.1001(a) III, IV.A.1 & IV.B.2 128.1.a & 311
835.1001(b) IV.B.2, IV.B.5 & IV.B.7 311
835.1002 III 128
835.1002(a) & (b) IV.B.2 128.1.a & 311
835.1002(d) IV.B.2 312
835.1003 III -
835.1003(a) IV, IV.B.2, IV.B.5 & IV.C.9.a 213.1
835.1301(e) IV.C.9 781.4
Appendix B - Inspection & Survey Frequencies For Routine Operations
APPENDIX B
Inspection & Survey Frequencies For Routine Operations
(Performed by Operations Organization)
Source Requiring Exempt Shielded Open Unattended
Radiation Controls Shielded
----------------------------------------------------------------------
Radioactive Material 5C 5G 1F (+) 4E
X-ray (<1 MeV) (*) 4E 5G 1F (+) 4E
Incidental X-ray 4E 4E 1F (+) 4E
Accelerator 5C 5H 5F (+) 4E
Inspection & Survey Frequencies For Routine Operations
(Performed by Radiation Protection Organization)
Source Requiring Exempt Shielded Open Unattended
Radiation Controls Shielded
----------------------------------------------------------------------
Radioactive Material 4E 3D 4A 4E
X-ray (<1 MeV) (*) 4E 3D 4A 4E
Incidental X-ray 4E 3D 4A 4E
Accelerator 4E 3D 4A 4E
Superscripted Notes:
(*) = For energies greater than 1000 kVp, use accelerator category.
(+) = Operator surveillance to control access required at all times.
Frequency of Inspections:
1 = Prior to each use to check that safety or monitoring devices
(e.g., interlocks, audible and/or visual warnings, or survey
instruments) are physically present and working and are
reasonably expected to remain operational over the duration
of use. Such activity constitutes an operational
inspection.
2 = Semiannual verification that the control or stationary area
monitoring devices, if interlocked to perform safety or
fail-safe functions, perform as intended when the RGD can
produce radiation. Such activity constitutes a functional
inspection. If the RGD cannot produce radiation (e.g., X-ray
machine in storage with power cables disabled), the functional
inspection is performed prior to future use.
3 = Annual functional inspection.
4 = Frequency determined by the radiation protection manager, or
3 if non-existent.
5 = 1 and 2.
Frequency of Radiological Surveys:
A = During each use in response to changing radiological conditions
or conditions that have the potential to change radiation
levels previously evaluated, or to post (or verify) the
l